"O'Hare, Andy"<EMAIL_ADDRESS> 07/11/2006 09:08 AM	To

Keith Barnett/RTP/USEPA/US@EPA

cc

Carl Koch/DC/USEPA/US@EPA, "Matz, Tim"<EMAIL_ADDRESS>Alan Kao

<EMAIL_ADDRESS> bcc

Subject

Draft HCl Report

Keith,

Attached please find a draft report summarizing the result of the HCl

modeling of virtually all U.S. portland cement plants.  The work was done

by Environ Corp on behalf of PCA.  Alan Kao with Environ will participate

in our meeting via conference phone on Thursday afternoon, and will

therefore be able to answer any questions you may have about the approach

or conclusions.

I plan to formally transmit this to the rulemaking docket when it is

reopened in the next few days.

See you on Thursday.

Regards,

Andy

Andrew T. O'Hare, CAE

Portland Cement Association

500 New Jersey Avenue, NW

7th Floor

Washington, DC  20001

Ph:<PHONE_NUMBER>

Fx:<PHONE_NUMBER>

Cell:<PHONE_NUMBER>

e-mail<EMAIL_ADDRESS>


[Federal Register Volume 88, Number 145 (Monday, July 31, 2023)]
[Notices]
[Pages 49508-49512]
[FR Doc No: 2023-16110]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-97985; File No. SR-NASDAQ-2023-022]

Self-Regulatory Organizations; The Nasdaq Stock Market LLC;
Notice of Filing of Proposed Rule Change To Create a New, Non-Trading
Limited Membership Class and Impose Related Requirements for Principal
Underwriting Activity

July 25, 2023.
    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 July 12, 2023, 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, 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.
---------------------------------------------------------------------------

    \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 create a new, non-trading limited
membership class and impose related requirements for principal
underwriting activity, as described further below. The text of the
proposed rule change is available on the Exchange's website at https://listingcenter.nasdaq.com/rulebook/nasdaq/rules, at the principal office
of the Exchange, and at the Commission's Public Reference Room.

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

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

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

1. Purpose
    The purpose of the proposed rule change is to amend the Exchange's
Rules to create a new, limited membership class for those underwriters
seeking only to perform underwriting activity as the principal
underwriter on the Exchange \3\ (and not seeking access to trade via
the Nasdaq Market Center) and require a company applying for initial
listing in connection with a transaction involving an underwriter to
have a principal underwriter \4\ that is a member or limited member of
Nasdaq.
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    \3\ ``Principal underwriter'' will have the same definition used
in Rule 405 promulgated under the Securities Act of 1933
(``Securities Act''): an underwriter in privity of contract with the
issuer of the securities as to which he is underwriter. Such
definition provides that the term ``issuer'' in the definition of
``principal underwriter'' has the meaning given in Sections 2(4) and
2(11) of the Securities Act. 17 CFR 230.405.
    \4\ The Exchange proposes to apply the requirements herein to a
principal underwriter (defined as an underwriter in privity of
contract with the issuer of the securities as to which he is
underwriter) because the definition of principal underwriter points
to the lead underwriter, who is generally responsible for organizing
the offering, including tasks such as determining allocation of
shares and the offering price, in conjunction with the issuer.
Although offerings may require more than one underwriter, or a group
of underwriters known as an underwriting syndicate, the Exchange
proposes to focus on the lead underwriters given the substantial
role they typically play in the offering process.
---------------------------------------------------------------------------

    Specifically, the Exchange proposes to amend its General Rules to:
(i) add a definition of ``Limited Underwriting Member'' to General 1,
Section 1; (ii) add a new, limited underwriting

membership to General 3, Section 1031; and (iii) provide an exemption
from registration for certain investment banking representatives
associated solely with Limited Underwriting Members in General 4,
Section 1230, as described below. Finally, the Exchange proposes to
amend Equity 7, Section 10 to exempt Limited Underwriting Members from
being assessed a trading rights fee. In addition, the Exchange proposes
to amend Rule 5210 of the Listing Rules to impose a requirement that
each Company applying for initial listing in connection with a
transaction involving an underwriter have a principal underwriter that
is a Member or Limited Underwriting Member.
Background
    In the fall of 2022, Nasdaq observed instances of unusually high
price spikes immediately following the pricing of certain initial
public offerings (IPOs) on the Exchange and other national securities
exchanges, mostly with respect to small-cap companies whose offerings
were less than $25 million. In many instances, the IPO securities that
were the subject of these extreme price spikes then experienced equally
dramatic price declines to a level at or below the offering price.
These extreme price spikes may occur in the opening trade on an
exchange, or in continuous trading on the day of, or days immediately
following, the listing.
    Underwriters play a critical role as gatekeepers to the capital
markets in connection with the trading of newly issued securities.
Unusual price volatility following IPOs of certain small-cap issuers
highlights the essential role underwriters play. Nasdaq relies on
underwriters to select the selling syndicate and ensure that the shares
are placed in a way that is reasonably designed to allow liquid
trading, consistent with Nasdaq's listing requirements, and the
successful introduction of the company to the marketplace. In a recent
Equity Regulatory Alert,\5\ Nasdaq highlighted the important role of
underwriters as gatekeepers in the IPO process and the applicability of
market rules and the federal securities laws. The Financial Industry
Regulatory Authority (FINRA) and the New York Stock Exchange (NYSE)
published similar alerts at the same time.\6\ In Nasdaq's Equity
Regulatory Alert, the Exchange also noted:
---------------------------------------------------------------------------

    \5\ https://www.nasdaqtrader.com/MicroNews.aspx?id=ERA2022-9.
    \6\ https://www.nyse.com/publicdocs/nyse/markets/nyse/rule-interpretations/2022/NYSER_Reg_Memo_-_Regulatory_Scrutiny_in_Connection_with_IPOs_(2022.11.17_final).pdf;
https://www.finra.org/rules-guidance/notices/22-25.
---------------------------------------------------------------------------

    Nasdaq members, as well as the members of other self-regulatory
organizations, that underwrite IPOs, and that play other roles in the
offering process, should expect a heightened focus when an IPO
experiences unusual price movements. Nasdaq Regulation will continue to
investigate to determine whether such members have complied with
applicable rules designed to prevent fraudulent and manipulative acts
and practices, to promote just and equitable principles of trade, and
to protect investors and the public interest. Areas of focus will
include suspected manipulation and, beyond manipulation, whether the
members are complying with their obligation to observe high standards
of commercial honor and just and equitable principles of trade pursuant
to Nasdaq Rule General 9, Section 1(a). That rule sets forth a standard
intended to encompass a wide variety of conduct that may operate as an
injustice to investors or other participants in the marketplace.\7\
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    \7\ Supra note 5.
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    Notwithstanding the important role of underwriters, Nasdaq does not
currently require underwriters of companies that are going public on
the Exchange to be Members of the Exchange. As such, Nasdaq does not
have authority to require responses to investigative inquiries or to
enforce its Rules directly against non-member underwriters.\8\
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    \8\ Nasdaq does, however, have broad discretionary authority
over the initial and continued listing of securities in Nasdaq in
order to maintain the quality of and public confidence in its
market, to prevent fraudulent and manipulative acts and practices,
to promote just and equitable principles of trade, and to protect
investors and the public interest. The Exchange may request
information from companies that are going public on the Exchange.
The Exchange may also request information from non-Member
underwriters, but they are not required to respond to these
requests. As described further below, this proposal would provide
the Exchange with authority to directly obtain information from
Limited Underwriting Members, whether pre or post-IPO.
---------------------------------------------------------------------------

    Nasdaq proposes creating a new, limited membership class and
requiring underwriters involved in Nasdaq-listed IPOs to be Members or
Limited Underwriting Members in order to serve as a principal
underwriter of an IPO on the Exchange. By creating a new, limited
membership class, Nasdaq would provide those firms seeking only to
perform principal underwriting activity on the Exchange (and not
seeking access to trade via the Nasdaq Market Center) the option of
selecting a membership that is less burdensome (i.e., to become a
Limited Underwriting Member rather than a Member).\9\
---------------------------------------------------------------------------

    \9\ A revised Membership Application is attached [sic] as
Exhibit 3, in which Nasdaq proposes to add a category for Limited
Underwriting Members and clarify that Limited Underwriting Members
are not subject to the requirement to provide an NSCC account
number.
---------------------------------------------------------------------------

Proposed Changes to Listing Rules
    The proposed rule change primarily impacts membership rules and
other non-listing rules, which would apply to the underwriters
themselves. However, as part of the proposal, Nasdaq would impose a new
requirement in its Listing Rules at 5210(l), requiring each Company
applying for initial listing in connection with a transaction involving
an underwriter to have a principal underwriter that is a Member or
Limited Underwriting Member of Nasdaq. In proposed Rule 5210(l), the
Exchange would also specify that ``principal underwriter'' shall have
the same definition used in Rule 405 promulgated under the Securities
Act.\10\ The rule would cross reference the definition of ``Limited
Underwriting Member,'' which is proposed to be added at General 1,
Section 1, and would define Limited Underwriting Member to mean a
broker or dealer admitted to limited underwriting membership in Nasdaq.
---------------------------------------------------------------------------

    \10\ Supra note 3.
---------------------------------------------------------------------------

Proposed Changes to General Rules
    Within its General Rules, the Exchange proposes to amend General 1
(General Provisions), General 3 (Membership and Access), and General 4
(Registration Requirements).
    The Exchange proposes to add the definition of ``Limited
Underwriting Member'' to General 1, Section 1 (Definitions). As noted
above, the Exchange proposes to define Limited Underwriting Member to
mean a broker or dealer admitted to limited underwriting membership in
Nasdaq.
    The Exchange proposes to add the new category of membership to
General 3, Section 1031, within which the Exchange proposes to include
information about persons eligible to become Limited Underwriting
Members, Limited Underwriting Member access to the Exchange, and rules
applicable to Limited Underwriting Members.
    The Exchange would specify in General 3, Section 1031(a), that (i)
any registered broker or dealer shall be eligible for limited
underwriting membership in the Exchange, except such registered brokers
or dealers as are excluded under paragraph (b) of Rule 1002; \11\ and
(ii) any person shall be

eligible to become an Associated Person of a Limited Underwriting
Member, except such persons as are excluded under paragraph (b) of Rule
1002.\12\ Proposed Rule 1031(a) is consistent with the existing rules
for persons eligible to become Members and Associated Persons in
General 3, Rule 1002(a).
---------------------------------------------------------------------------

    \11\ In relevant part, General 3, Section 1002(b) provides that,
subject to certain exceptions, no registered broker or dealer shall
be admitted to membership, and no Member shall be continued in
membership, if such broker, dealer, or Member fails or ceases to
satisfy the qualification requirements established by the Rules, or
if such broker, dealer, or Member is or becomes subject to a
statutory disqualification, or if such broker, dealer, or Member
fails to file such forms as may be required in accordance with such
process as the Exchange may prescribe.
    \12\ In relevant part, General 3, Section 1002(b) provides that,
subject to such exceptions as may be explicitly provided elsewhere
in the Rules, no person shall become associated with a Member,
continue to be associated with a Member, or transfer association to
another Member, if such person fails or ceases to satisfy the
qualification requirements established by the Rules, or if such
person is or becomes subject to a statutory disqualification; and no
broker or dealer shall be admitted to membership, and no Member
shall be continued in membership, if any person associated with it
is ineligible to be an Associated Person under this subsection.
---------------------------------------------------------------------------

    The Exchange proposes to state, in General 3, Section 1031(b) that
(i) a limited underwriting membership provides no rights to transact on
the Exchange and (ii) a limited underwriting membership is solely to
allow a firm that is not otherwise a Member to serve as a principal
underwriter for a Company seeking to list on the Exchange, pursuant to
Rule 5210(l).
    Nasdaq proposes applying a limited ruleset to this newly proposed
limited membership class.\13\ Specifically, the Exchange proposes to
apply only the following rules to Limited Underwriting Members: General
1 (General Provisions); General 2 (Organization and Administration),
with the exception of Sections 6(a) and 22; General 3 (Membership and
Access); General 4 (Registration Requirements); General 5 (Discipline),
with the exception of Rules 8211 and 9557; General 9 (Regulation),
Sections 1 and 20; and Equity 7, Section 10 (Pricing Schedule,
Membership Fees). The Exchange would specify the aforementioned rules
applicable to this new membership class in General 3, Section
1031(c)(1). With the proposal, the Exchange aims to apply only those
rules it deems appropriate to a firm serving as a principal
underwriter, including those rules it deems critical to such firms.
---------------------------------------------------------------------------

    \13\ Members of the Exchange, unlike Limited Underwriting
Members, are subject to all of the Exchange's Rules (which includes
the limited ruleset applicable to the newly proposed limited
membership class).
---------------------------------------------------------------------------

    The Exchange proposes to apply General 1 to Limited Underwriting
Members because General 1 provides defined terms that would be
applicable to Limited Underwriting Members and, as explained above, the
proposed rule change would also add a definition (``Limited
Underwriting Member'') to General 1.
    The Exchange proposes to apply General 2 (with the exception of
Sections 6(a) and 22) to Limited Underwriting Members because General 2
relates to organization and administration including requirements
surrounding fees, limitations on affiliations, and a requirement for an
executive representative, among other obligations. The Exchange
proposes to specifically exclude General 2, Sections 6(a) and Section
22. General 2, Section 6(a) states that General Equity and Options
Rules and Equity Rules shall apply to all members and persons
associated with a member, which is not accurate in the case of Limited
Underwriting Members. General 2, Section 22 relates to Sponsored
Participants and client access to the Nasdaq Market Center via a
Member, which is not applicable to underwriting activity.
    The Exchange also proposes to subject Limited Underwriting Members
to General 3 because General 3 contains membership rules, including an
obligation to follow specified procedures for applying to be a member,
making changes to membership, or terminating membership. As described
herein, the proposed rule change would also add additional details
regarding the limited underwriting membership to General 3, Rule 1031.
    The Exchange proposes to apply General 4 to Limited Underwriting
Members, which includes registration requirements that are applicable
to Limited Underwriting Members. The proposal would also add an
exemption within General 4, as described below.
    The Exchange believes it is critical to subject Limited
Underwriting Members to General 5 (with the exception of Rules 8211 and
9557), which contains the Exchange's disciplinary rules.\14\ Notably,
General 5, Rule 8210 provides the Exchange with authority to require
information from Exchange Members. The Exchange proposes to
specifically exclude General 5, Rule 8211 and Rule 9557. Rule 8211
relates to members submission of trade data. Rule 9557 relates to
procedures for regulating activities under General 9, Sections 40 and
41, which incorporate FINRA Rules 4110 and 4120, which relate to FINRA
carrying or clearing members. Therefore, Rule 8211 and Rule 9557 are
not relevant to underwriting activity.
---------------------------------------------------------------------------

    \14\ General 5, Rule 8001 provides that the Exchange and FINRA
are parties to the FINRA Regulatory Contract (often referred to as a
Regulatory Services Agreement (``RSA'')) pursuant to which FINRA has
agreed to perform certain functions described in the Exchange's
Rules on behalf of the Exchange. The Exchange does not anticipate
that the proposed rule change would have any material impact on the
current RSA.
---------------------------------------------------------------------------

    The Exchange also believes it is important to subject Limited
Underwriting Members to General 9, Section 1 which includes general
standards by which Members must abide. Specifically, of importance,
General 9, Section 1(a) requires Members to observe just and equitable
principles of trade. General 9, Section 20 requires Members to
establish and maintain a system to supervise the activities of each
registered representative and associated person that is reasonably
designed to achieve compliance with applicable securities laws and
regulations and with applicable Nasdaq rules. The Exchange believes it
is important to apply this provision on supervision as it would provide
the Exchange with authority to assess whether a Limited Underwriting
Member has an adequate supervisory system and written supervisory
procedures in place.
    Finally, the Exchange proposes to include Equity 7, Section 10 to
Limited Underwriting Members because this section includes the
membership and application fees applicable to Limited Underwriting
Members. The Exchange proposes to avoid applying all those Exchange
rules not specified in proposed General 3, Section 1031(c)(1) to
Limited Underwriting Members in an effort to impose minimal burden on
Limited Underwriting Members, while still allowing the Exchange to have
regulatory authority over such members. Furthermore, the Exchange
believes that the Exchange's rules that Limited Underwriting Members
would not be subject to under the proposal primarily relate to trading
activity and are, therefore, not relevant to the activities of Limited
Underwriting Members.
    The Exchange proposes to include language in General 3, Section
1031(c)(1) providing that, for purposes of interpreting and applying
the rules to Limited Underwriting Members, references to ``Member,''
``Members,'' or ``membership'' shall be functionally equivalent to
``Limited Underwriting Member,'' ``Limited Underwriting Members,'' or
``limited underwriting membership'' respectively. The Exchange also
proposes to include a

requirement, in General 3, Section 1031(c)(2), that Limited
Underwriting Members and their Associated Persons shall at all times be
members of FINRA.\15\
---------------------------------------------------------------------------

    \15\ Limited Underwriting Members would, therefore, be eligible
to waive-in to Exchange membership, as provided for in General 3,
Section 1013(b). Prospective Limited Underwriting Members would need
to submit a membership application (see supra note 9) in which they
would select ``Waive-In Membership'' for the application type and
``Limited Underwriting Member of NQX'' for the nature of intended
activity. For ``waive-in'' applicants, the Exchange relies
substantially upon FINRA's determination to approve the applicant
for FINRA membership when the Exchange evaluates the applicant for
Exchange membership.
---------------------------------------------------------------------------

    Finally, the Exchange proposes to exempt persons associated solely
with a Limited Underwriting Member whose functions are related solely
and exclusively to underwriting and who are registered with FINRA as an
Investment Banking Representative \16\ from the requirement to register
with the Exchange. The Exchange proposes to add such exemption to
General 4, Section 1230(4).
---------------------------------------------------------------------------

    \16\ In FINRA Rule 1220(b)(5), FINRA describes the requirement
for representatives to register as an ``Investment Banking
Representative'' if his or her activities in the investment banking
or securities business of a member involve: (i) advising on or
facilitating debt or equity securities offerings through a private
placement or a public offering, including but not limited to
origination, underwriting, marketing, structuring, syndication, and
pricing of such securities and managing the allocation and
stabilization activities of such offerings, or (ii) advising on or
facilitating mergers and acquisitions, tender offers, financial
restructurings, asset sales, divestitures or other corporate
reorganizations or business combination transactions, including but
not limited to rendering a fairness, solvency or similar opinion.
---------------------------------------------------------------------------

Proposed Change to Equity Rules
    The Exchange proposes to exempt Limited Underwriting Members from
the trading rights fee of $1,250 per month that is normally charged to
Members because such Limited Underwriting Members would not be eligible
to trade on the Exchange. Accordingly, the Exchange proposes to add
language to Equity 7, Section 10(a) to specify that Limited
Underwriting Members would not be charged the monthly trading rights
fee. Limited Underwriting Members would be subject to a $2,000
application fee (per Equity 7, Section 10(b)) and a $3,000 yearly
membership fee (per Equity 7, Section 10(a)).
Implementation
    The Exchange would designate the proposed changes to be operative
60 days after publication of the Commission's approval order of SR-
NASDAQ-2023-022 in the Federal Register. This delay will allow time for
firms involved with upcoming IPOs to become Limited Underwriting
Members, if they choose, and for companies planning IPOs to select
alternative underwriters if their current firm is not, and does not
intend to become, a Member or Limited Underwriting Member.
2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act,\17\ in general, and furthers the objectives of Section
6(b)(5) of the Act,\18\ in particular, in that it is designed to
promote just and equitable principles of trade, 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, by strengthening Nasdaq's ability to carry out its oversight
responsibilities. It is also consistent with Section 6(b)(7) of the Act
in that it provides for a fair procedure for prohibiting or limiting
any person with respect to access to services offered by the Exchange
or a Member thereof.\19\ As discussed above, the proposal would create
a new, limited membership class for those firms seeking only to perform
activity as the principal underwriter of an IPO on the Exchange (and
not seeking access to trade via the Nasdaq Market Center) and require a
company applying for initial listing in connection with a transaction
involving an underwriter to have a principal underwriter that is a
member or limited member of Nasdaq. The Exchange would apply specified
rules to Limited Underwriting Members, as explained above. Such rules
include general provisions and standards, membership and access rules,
organization and administration rules, registration requirements,
disciplinary rules, and certain fees. Creating this new membership
class and subjecting principal underwriters to such specified rules
supports fair and orderly markets, which protects investors and the
public interest, consistent with Section 6(b)(5) of the Act. Notably,
the proposal would subject Limited Underwriting Members to Nasdaq's
disciplinary rules, which provides Nasdaq authority to require
information from such underwriters (per General 5, Rule 8210), as well
as other general rules, including the requirement to observe just and
equitable principles of trade (per General 9, Section 1(a)) and the
requirement to establish and maintain a system to supervise the
activities of registered representatives and associated persons (per
General 9, Section 20). Nasdaq believes that imposing these Nasdaq
rules, as well as the other rules included in proposed Rule 1031(c)(1),
on principal underwriters will strengthen Nasdaq's ability to carry out
its oversight responsibilities and deter potential violative conduct,
such as fraud or manipulation, thereby protecting investors and the
public interest.
---------------------------------------------------------------------------

    \17\ 15 U.S.C. 78f(b).
    \18\ 15 U.S.C. 78f(b)(5).
    \19\ 15 U.S.C. 78f(b)(7).
---------------------------------------------------------------------------

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

    The Exchange does not believe that the proposed rule change will
impose any burden on competition not necessary or appropriate in
furtherance of the purposes of the Act. The proposed changes to the
Listing Rules will apply equally to all similarly situated companies
applying for initial listing in connection with a transaction involving
an underwriter on the Exchange. Likewise, the proposed changes to the
General and Equity Rules, including to the membership rules, will apply
equally to all similarly situated Applicants and Members and they will
confer no relative advantage or disadvantage upon any category of
Exchange Applicant or Member. Although the Exchange proposes to subject
Limited Underwriting Members to a limited set of rules, the limited
underwriting membership does not confer the same benefits as a standard
Exchange membership. Namely, a Limited Underwriting Member would not be
permitted to transact on the Nasdaq Market Center. Therefore, applying
a limited ruleset to Limited Underwriting Members is justified. All
Limited Underwriting Members would be subject to the same specified
rules, as noted above. Moreover, the Exchange does not expect that its
proposal will have an adverse impact on competition among exchanges for
members. The Exchange believes the proposed rule changes, overall, will
strengthen the Exchange's ability to carry out its role and
responsibilities as a self-regulatory organization and deter potential
violative conduct. As such, the Exchange does not believe that the
proposed rule change will impose any burden on competition not
necessary or appropriate in furtherance of the purposes of the Act.

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

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

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's internet comment form (https://www.sec.gov/rules/sro.shtml); or
     Send an email to [email protected]. Please include
file number SR-NASDAQ-2023-022 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-2023-022. 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 (https://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
a.m. and 3 p.m. Copies of the filing also will be available for
inspection and copying at the principal office of the Exchange. Do not
include personal identifiable information in submissions; you should
submit only information that you wish to make available publicly. We
may redact in part or withhold entirely from publication submitted
material that is obscene or subject to copyright protection. All
submissions should refer to file number SR-NASDAQ-2023-022 and should
be submitted on or before August 21, 2023.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\20\
---------------------------------------------------------------------------

    \20\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

J. Matthew DeLesDernier,
Deputy Secretary.
[FR Doc. 2023-16110 Filed 7-28-23; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 81, Number 127 (Friday, July 1, 2016)]
[Notices]
[Pages 43212-43214]
[FR Doc No: 2016-15661]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-1662]

Vulvovaginal Candidiasis: Developing Drugs for Treatment; Draft
Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled
``Vulvovaginal Candidiasis: Developing Drugs for Treatment.'' The
purpose of this guidance is to assist sponsors in the clinical
development of drugs for the treatment of uncomplicated vulvovaginal
candidiasis (VVC).

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by September 29, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://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 http://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): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, 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-2016-D-1662 for ``Vulvovaginal Candidiasis: Developing Drugs for
Treatment; Draft Guidance for Industry; Availability.'' Received
comments will be placed in the docket and, except for those submitted
as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9
a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
    Submit written requests for single copies of the draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one
self-addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Shrimant Mishra, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 6382, Silver Spring, MD 20993-0002, 301-
796-1400.

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Vulvovaginal Candidiasis: Developing Drugs for Treatment.''
The purpose of this guidance is to assist sponsors in the development
of drugs for the treatment of uncomplicated VVC.
    This guidance helps define enrollment criteria for VVC trials, and
recommends that such trials be superiority trials against placebo or
active control. The recommended efficacy endpoint is resolution of
clinical signs and symptoms. In addition, this guidance reflects recent
developments in scientific information that pertain to drugs being
developed for the treatment of VVC.
    Issuance of this guidance fulfills a portion of the requirements of
Title VIII, section 804, of the Food and Drug Administration Safety and
Innovation Act (Pub. L. 112-144), which requires FDA to review and, as
appropriate, revise not fewer than three guidance documents per year
for the conduct of clinical trials with respect to antibacterial and
antifungal drugs. In 1998, FDA published a draft guidance entitled
``Vulvovaginal Candidiasis: Developing Antimicrobial Drugs for
Treatment'' (the 1998 draft guidance). In a Federal Register notice
dated August 7, 2013 (78 FR 48175), FDA announced an initiative in the
Center for Drug Evaluation and Research involving the review of draft
guidance documents issued before 2010 to determine their status and to
decide whether those guidances should be withdrawn, revised, or
finalized with only minor changes. In the August 2013 Federal Register
notice, FDA announced that the 1998 draft guidance, as well as other
draft guidances, was being withdrawn because new information,
scientific developments, and emerging technologies required a revision.
FDA is now issuing a new draft guidance that revises the
recommendations in the 1998 draft guidance.
    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 this topic. 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. The Paperwork Reduction Act of 1995

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

III. Electronic Access

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

    Dated: June 27, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-15661 Filed 6-30-16; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 77, Number 224 (Tuesday, November 20, 2012)]
[Notices]
[Page 69648]
[FR Doc No: 2012-28109]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4089-DR; Docket ID FEMA-2012-0002]

Rhode Island; Major Disaster and Related Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This is a notice of the Presidential declaration of a major
disaster for the State of Rhode Island (FEMA-4089-DR), dated November
3, 2012, and related determinations.

DATES: Effective Date: November 3, 2012.

FOR FURTHER INFORMATION CONTACT: Peggy Miller, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW.,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Notice is hereby given that, in a letter
dated November 3, 2012, the President issued a major disaster
declaration under the authority of the Robert T. Stafford Disaster
Relief and Emergency Assistance Act, 42 U.S.C. 5121 et seq. (the
``Stafford Act''), as follows:

    I have determined that the damage in certain areas of the State
of Rhode Island resulting from Hurricane Sandy during the period of
October 26-31, 2012, is of sufficient severity and magnitude to
warrant a major disaster declaration under the Robert T. Stafford
Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121 et seq.
(the ``Stafford Act''). Therefore, I declare that such a major
disaster exists in the State of Rhode Island.
    In order to provide Federal assistance, you are hereby
authorized to allocate from funds available for these purposes such
amounts as you find necessary for Federal disaster assistance and
administrative expenses.
    You are authorized to provide Public Assistance in the
designated areas and Hazard Mitigation throughout the State. Direct
Federal assistance is authorized. Consistent with the requirement
that Federal assistance is supplemental, any Federal funds provided
under the Stafford Act for Public Assistance and Hazard Mitigation
will be limited to 75 percent of the total eligible costs.
    Further, you are authorized to make changes to this declaration
for the approved assistance to the extent allowable under the
Stafford Act.

    The Federal Emergency Management Agency (FEMA) hereby gives notice
that pursuant to the authority vested in the Administrator, under
Executive Order 12148, as amended, James N. Russo, of FEMA is appointed
to act as the Federal Coordinating Officer for this major disaster.
    The following areas of the State of Rhode Island have been
designated as adversely affected by this major disaster:

    Bristol, Newport, and Washington Counties for Public Assistance.
Direct federal assistance is authorized.
    All counties within the State of Rhode Island are eligible to
apply for assistance under the Hazard Mitigation Grant Program.

The following Catalog of Federal Domestic Assistance Numbers (CFDA)
are to be used for reporting and drawing funds: 97.030, Community
Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling;
97.033, Disaster Legal Services; 97.034, Disaster Unemployment
Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048,
Disaster Housing Assistance to Individuals and Households In
Presidentially Declared Disaster Areas; 97.049, Presidentially
Declared Disaster Assistance--Disaster Housing Operations for
Individuals and Households; 97.050, Presidentially Declared Disaster
Assistance to Individuals and Households--Other Needs; 97.036,
Disaster Grants--Public Assistance (Presidentially Declared
Disasters); 97.039, Hazard Mitigation Grant.

W. Craig Fugate,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2012-28109 Filed 11-19-12; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register: June 30, 2006 (Volume 71, Number 126)]
[Notices]
[Page 37558-37559]
[DOCID:fr30jn06-59]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP06-355-001]

[Gulf South Pipeline Company, LP; Notice of Compliance Filing]

June 23, 2006.
    Take notice that on June 21, 2006 Gulf South Pipeline Company, LP
(Gulf South) tendered for filing as part of its FERC Gas Tariff, Sixth
Revised Volume No. 1, the following tariff sheets, to become effective
June 9, 2006:

Substitute First Revised Sheet No. 3701.
Substitute Fourth Revised Sheet No. 3702.
Original Sheet No. 3702A.
Substitute Third Revised Sheet No. 3705.

    Gulf South states that copies of the filing were served on parties
on the official service list in the above-captioned proceeding.
    Any person desiring to protest this filing must file in accordance
with Rule 211 of the Commission's Rules of Practice and Procedure (18
CFR 385.211). Protests to this filing will be considered by the
Commission in determining the appropriate action to be taken, but will
not serve to make protestants parties to the proceeding. Such protests
must be filed in accordance with the provisions of Section 154.210 of
the Commission's regulations (18 CFR 154.210). Anyone filing a protest
must serve a copy of that document on all the parties to the
proceeding.
    The Commission encourages electronic submission of protests in lieu
of paper using the ``eFiling'' link at http://www.ferc.gov. Persons

unable to file electronically should submit an original and 14 copies
of the protest to the Federal Energy Regulatory Commission, 888 First
Street, NE., Washington, DC 20426.
    This filing is accessible on-line at http://www.ferc.gov, using the

``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For

TTY, call<PHONE_NUMBER>.

Magalie R. Salas,
Secretary.
[FR Doc. E6-10305 Filed 6-29-06; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 82, Number 138 (Thursday, July 20, 2017)]
[Notices]
[Pages 33529-33530]
[FR Doc No: 2017-15192]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-81147; File No. SR-GEMX-2017-30]

Self-Regulatory Organizations; Nasdaq GEMX, LLC; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change To Remove Outdated
Language in the Exchange's Rulebook and Fee Schedule

July 14, 2017.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on July 5, 2017, Nasdaq GEMX, LLC (``GEMX'' or ``Exchange'') filed with
the Securities and Exchange Commission (``Commission'') the proposed
rule change as described in Items I, II, and III, below, which Items
have been prepared by the Exchange. The Commission is publishing this
notice to solicit comments on the proposed rule change from interested
persons.
---------------------------------------------------------------------------

    \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 remove outdated rule text from GEMX's
Rulebook and Fee Schedule.
    The text of the proposed rule change is available on the Exchange's
Web site at www.ise.com, at the principal office of the Exchange, and
at the Commission's Public Reference Room.

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

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

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

1. Purpose
    The Exchange proposes to remove certain rule text in the GEMX
Rulebook and Fee Schedule which reflects certain dates which are no
longer applicable. The Exchange proposes to remove the proposed
outdated rule text to avoid confusion in the Rulebook and Fee Schedule.
Each change is discussed below.
    The Exchange proposes to remove text from GEMX Rule 716, entitled
``Block Trades.'' Specifically, the Exchange proposes to remove the
following rule text, ``The Block Order Mechanism in Rule 716(c) will
not be available on a date prior to February 27, 2017, the date to be
announced in a separate Market Information Circular. The Exchange will
recommence the Block Order Mechanism on Nasdaq GEMX prior to June 1,
2017, the date to be announced in a separate Market Information
Circular.'' This rule text was added at the time the Exchange proposed
to delay this functionality.\3\ The Exchange recommenced the Block
Order Mechanism on May 30, 2017.\4\ The text is no longer applicable.
---------------------------------------------------------------------------

    \3\ See Securities Exchange Act Release No. 80101 (February 24,
2017), 82 FR 12380 (March 2, 2017) (SR-ISEGemini-2017-05).
    \4\ See Options Trader Alert #2017-38.
---------------------------------------------------------------------------

    The Exchange proposes to remove the following outdated sentences in
Sections I and II of the Fee Schedule:
     There will be no fees or rebates for trades in options
overlying Symbol CPN executed on February 27-28, 2017.\5\
---------------------------------------------------------------------------

    \5\ This rule text was added to the Fee Schedule in connection
with a pricing change. See Securities Exchange Act Release No. 80184
(March 9, 2017), 82 FR 13893 (March 15, 2017) (SR-ISEGemini-2017-
09).
---------------------------------------------------------------------------

     For March 2017 only, all Qualifying Tier Threshold ADV
calculations will be based on the better of (1) the member's full month
ADV for the period of March 1-31, 2017, or (2) the member's ADV for the
period of March 1-24, 2017.\6\
---------------------------------------------------------------------------

    \6\ Id.
---------------------------------------------------------------------------

     Volume executed in options overlying Symbol CPN on
February 27-28, 2017 will not be counted towards a member's tier for
February activity.\7\
---------------------------------------------------------------------------

    \7\ Id.
---------------------------------------------------------------------------

    The operative dates for the pricing noted above has expired. The
Exchange desires to remove the outdated text from its Fee Schedule to
avoid confusion.
2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b)

of the Act,\8\ in general, and furthers the objectives of Section
6(b)(5) of the Act,\9\ in particular, in that it is designed to promote
just and equitable principles of trade, 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,
by removing outdated text in the Exchange's Rulebook and Fee Schedule
which applied at one point in time and is no longer applicable.
Removing the outdated text will avoid confusion as to its
applicability.
---------------------------------------------------------------------------

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

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

    The Exchange does not believe that the proposed rule change will
impose any burden on competition not necessary or appropriate in
furtherance of the purposes of the Act. The Exchange's proposal to
remove the outdated text does not impose an undue burden on competition
because the specified text does not apply to any market participant.

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 foregoing proposed rule change does not: (i)
Significantly affect the protection of investors or the public
interest; (ii) impose any significant burden on competition; and (iii)
become operative for 30 days from the date on which it was filed, or
such shorter time as the Commission may designate, it has become
effective pursuant to Section 19(b)(3)(A)(iii) of the Act \10\ and
subparagraph (f)(6) of Rule 19b-4 thereunder.\11\
---------------------------------------------------------------------------

    \10\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \11\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)
requires a self-regulatory organization to give the Commission
written notice of its intent to file the proposed rule change at
least five business days prior to the date of filing of the proposed
rule change, or such shorter time as designated by the Commission.
The Exchange has satisfied this requirement.
---------------------------------------------------------------------------

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

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-GEMX-2017-30 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-GEMX-2017-30. 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 Web site (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 Web site 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; the Commission does
not 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-GEMX-2017-30 and should be
submitted on or before August 10, 2017.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\12\
---------------------------------------------------------------------------

    \12\ 17 CFR 200.30-3(a)(12).
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Jill M. Peterson,
Assistant Secretary.
[FR Doc. 2017-15192 Filed 7-19-17; 8:45 am]
 BILLING CODE 8011-01-P