[Federal Register Volume 76, Number 56 (Wednesday, March 23, 2011)]
[Notices]
[Pages 16462-16464]
[FR Doc No: 2011-6785]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-64090; File No. SR-BX-2011-007]

Self-Regulatory Organizations; NASDAQ OMX BX LLC; Order Approving
a Proposed Rule Change Relating to Permanent Approval of the BX and NES
Inbound Routing Relationship

March 17, 2011.

I. Introduction

    On January 28, 2011, NASDAQ OMX BX LLC (``BX'' or ``Exchange'')
filed with the Securities and Exchange Commission (``Commission''),
pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ a proposed rule

change requesting permanent approval of the Exchange's pilot program to
permit the Exchange to accept inbound orders that Nasdaq Execution
Services, LLC (``NES'') routes in its capacity as a facility of The
NASDAQ Stock Market LLC (``Nasdaq''), with certain obligations and
conditions. The proposed rule change was published for comment in the
Federal Register on February 14, 2011.\3\ The Commission received no
comment letters regarding the proposed rule change. This order approves
the proposed rule change.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 63859 (February 7,
2011), 76 FR 8391 (``Notice'').
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II. Background

    BX Equity Rule 2140(a) prohibits the Exchange or any entity with
which it is affiliated from acquiring or maintaining an ownership
interest in a member in the absence of an effective filing under
Section 19(b) of the Act.\4\ NES is a broker-dealer that is a member of
the Exchange, and currently provides to Nasdaq members optional routing
services to other market centers. NES is owned by The NASDAQ OMX Group,
Inc. (``NASDAQ OMX''), which also owns three registered securities
exchanges--Nasdaq, the Exchange, and NASDAQ OMX PHLX LLC.\5\ Thus, NES
is an affiliate of each of these exchanges. Absent an effective filing,
BX Equity Rule 2140(a) would prohibit NES from being a member of the
Exchange.
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    \4\ 15 U.S.C. 78s(b).
    \5\ See Securities Exchange Act Release No. 58324 (August 7,
2008), 73 FR 46936 (August 12, 2008) (SR-BSE-2008-02; SR-BSE-2008-
23; SR-BSE-2008-25; SR-BSECC-2008-01) (``BSE Approval Order''). See
also Securities Exchange Act Release No. 58179 (July 17, 2008), 73
FR 42874 (July 23, 2008) (order approving NASDAQ OMX's acquisition
of Phlx.)
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    On August 7, 2008, in connection with the acquisition of the
Exchange by NASDAQ OMX, the Commission, approved an affiliation between
the Exchange and NES for the limited purpose of permitting NES to
provide routing services for Nasdaq for orders that first attempt to
access liquidity on Nasdaq's system before routing to the Exchange,
subject to certain other limitations and conditions.\6\ At the time of
NASDAQ OMX's acquisition of the Exchange, the Exchange was not trading
equity securities.\7\ On December 23, 2008, in connection with the
Exchange's resumption of equity trading, the Commission approved a
modification to the conditions for the affiliation between NES and the
Exchange, to permit the Exchange to receive orders routed by NES in its
capacity as a facility of Nasdaq (including ``Directed Orders''),\8\ on
a one-year pilot basis.\9\ The Exchange is now proposing to make such
approval permanent.\10\
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    \6\ See BSE Approval Order, supra note 5.
    \7\ See BSE Approval Order, supra note 5, 73 FR at 46944, n.117.
    \8\ Nasdaq Rule 4751(f)(9) defines Directed Orders as immediate-
or-cancel orders that are directed to an exchange other than Nasdaq
without checking the Nasdaq book.
    \9\ See Securities Exchange Act Release No. 59154 (December 23,
2008), 73 FR 80468 (December 31, 2008) (SR-BSE-2008-48) (``BSE
Inbound Routing Order'').
    \10\ See Notice, supra note 3.
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III. Discussion and Commission Findings

    After careful review, the Commission finds that the proposed rule
change is consistent with the requirements of the Act and the rules and
regulations thereunder applicable to a national securities
exchange.\11\ Specifically, the Commission finds that the proposed rule
change is consistent with Section 6(b)(1) of the Act,\12\ which
requires, among other things, that a national securities exchange be so
organized and have the capacity to carry out the purposes of the Act,
and to comply and enforce compliance by its members and persons
associated with its members, with the provisions of the Act, the rules
and regulation thereunder, and the rules of the Exchange. Further, the
Commission finds that the proposed rule change is consistent with
Section 6(b)(5) of the Act,\13\ which requires, among other things,
that the rules of a national securities exchange be 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 regulating, clearing, settling, and 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. Section 6(b)(5) also
requires that the rules of an exchange not be designed to permit unfair
discrimination among customers, issuers, brokers, or dealers.
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    \11\ In approving this proposed rule change, the Commission has
considered the proposed rule's impact on efficiency, competition and
capital formation. 15 U.S.C. 78c(f).
    \12\ 15 U.S.C. 78f(b)(1).
    \13\ 15 U.S.C. 78f(b)(5).
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    NES operates as a facility of Nasdaq that provides outbound routing
from Nasdaq to other market centers, subject to certain conditions.\14\
NES's operation as a facility providing outbound routing services for
Nasdaq is subject to the conditions that: (1) NES is operated and
regulated as a facility of Nasdaq; (2) NES only provides outbound
routing services unless otherwise approved by the Commission; (3) the
designated examining authority of NES is a self-regulatory organization
unaffiliated with Nasdaq; and (4) the use of NES for outbound routing
is available only to Nasdaq members and the use of NES remains
optional.\15\
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    \14\ See Nasdaq Rule 4758. See also Notice, supra note 3, 76 FR
at 8301, n.5.
    \15\ Id. See also BSE Inbound Routing Order, supra note 9, 73 FR
at 80475.
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    The operation of NES as a facility of Nasdaq providing outbound
routing services from that exchange will be subject to Nasdaq
oversight, as well as Commission oversight. Nasdaq will be responsible
for ensuring that NES's outbound routing function is operated
consistent with Section 6 of the Act and Nasdaq rules. In addition,
Nasdaq must file with the Commission rule changes and fees relating to
NES's outbound routing function.
    Recognizing that the Commission has previously expressed concern
regarding the potential for conflicts of interest in instances where a
member firm is affiliated with an exchange of which it is a member, the
Exchange previously proposed, and the Commission approved, limitations
and conditions on NES's affiliation with the Exchange.\16\ Also
recognizing that the Commission has expressed concern regarding the
potential for conflicts of interest in instances where a member firm is
affiliated with an exchange to which it is routing orders, the Exchange
previously proposed, and the Commission approved,\17\ NES's affiliation
with the Exchange to permit the Exchange to accept inbound orders that
NES routes in its capacity as a facility of Nasdaq, subject to the
following limitations and conditions, which the Exchange states it has
met: \18\
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    \16\ See BSE Approval Order, supra note 5, 73 FR at 46944.
    \17\ See BSE Inbound Routing Order, supra note 9, 73 FR at
80475.
    \18\ See Notice, supra note 3, 73 FR at 8391-8392.
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     First, the Exchange and FINRA will enter into a Regulatory
Contract, as well as an agreement pursuant to Rule 17d-2 under the Act
(``17d-2 Agreement'').\19\ Pursuant to the Regulatory Contract and the
17d-2 Agreement, FINRA will be allocated regulatory responsibilities to
review NES's compliance with certain Exchange rules.\20\ Pursuant to
the Regulatory Contract, however, BX

retains ultimate responsibility for enforcing its rules with respect to
NES.
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    \19\ 17 CFR 240.17d-2.
    \20\ The Exchange also states that NES is subject to independent
oversight by FINRA, its Designated Examining Authority, for
compliance with financial responsibility requirements. See Notice,
supra note 3, 76 FR at 8391, n.9.
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     Second, FINRA will monitor NES for compliance with the
Exchange's trading rules, and will collect and maintain certain related
information.\21\
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    \21\ Pursuant to the Regulatory Contract, both FINRA and the
Exchange will collect and maintain all alerts, complaints,
investigations and enforcement actions in which NES (in its capacity
as a facility of Nasdaq routing orders to the Exchange) is
identified as a participant that has potentially violated applicable
Commission or Exchange rules. The Exchange and FINRA will retain
these records in an easily accessible manner in order to facilitate
any potential review conducted by the Commission's Office of
Compliance Inspections and Examinations. See Notice, supra note 3,
76 FR at 8391, n.10
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     Third, FINRA will provide a report to the Exchange's chief
regulatory officer (``CRO''), on a quarterly basis, that: (i)
Quantifies all alerts (of which FINRA is aware) that identify NES as a
participant that has potentially violated Commission or Exchange rules,
and (ii) lists all investigations that identify NES as a participant
that has potentially violated Commission or Exchange rules.\22\
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    \22\ See Notice, supra note 3, 76 FR at 8392.
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     Fourth, the Exchange has adopted BX Equity Rule 2140(c),
which requires NASDAQ OMX, as the holding company owning both the
Exchange and NES, to establish and maintain procedures and internal
controls reasonably designed to ensure that NES does not develop or
implement changes to its system, based on non-public information
obtained regarding planned changes to the Exchange's systems as a
result of its affiliation with the Exchange, until such information is
available generally to similarly situated Exchange members, in
connection with the provision of inbound order routing to the
Exchange.\23\
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    \23\ See BX Equity Rule 2140(c). See also Notice, supra note 3,
76 FR at 8392.
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     Fifth, routing of orders from NES to the Exchange, in
NES's capacity as a facility of Nasdaq, was authorized for a pilot
period of twelve months.\24\
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    \24\ See Notice, supra note 3, 76 FR at 8392. The Commission
notes that the original pilot period of twelve months was approved
and began on December 23, 2008, but was extended several times. See
Notice, supra note 3, 76 FR at 8391, n.6 and accompanying text.
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    The Exchange believes that by meeting the above-listed conditions
it has set up mechanisms that protect the independence of the
Exchange's regulatory responsibility with respect to NES, and has
demonstrated that NES cannot use any information advantage it may have
because of its affiliation with the Exchange.\25\
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    \25\ See Notice, supra note 3, 76 FR at 8392.
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    In the past, the Commission has expressed concern that the
affiliation of an exchange with one of its members raises potential
conflicts of interest, and the potential for unfair competitive
advantage.\26\ Although the Commission continues to be concerned about
potential unfair competition and conflicts of interest between an
exchange's self-regulatory obligations and its commercial interest when
the exchange is affiliated with one of its members, for the reasons
discussed below, the Commission believes that it is consistent with the
Act to permit NES to provide inbound routing to the Exchange on a
permanent basis instead of a pilot basis, subject to the other
conditions described above.
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    \26\ See, e.g., Securities Exchange Act Release Nos. 54170 (July
18, 2006), 71 FR 42149 (July 25, 2006) (SR-NASDAQ-2006-006) (order
approving Nasdaq's proposal to adopt Nasdaq Rule 2140, restricting
affiliations between Nasdaq and its members); 53382 (February 27,
2006), 71 FR 11251 (March 6, 2006) (SR-NYSE-2005-77) (order
approving the combination of the New York Stock Exchange, Inc. and
Archipelago Holdings, Inc.); 58673 (September 29, 2008), 73 FR 57707
(October 8, 2008) (SR-Amex-2008-62) (order approving the combination
of NYSE Euronext and the American Stock Exchange LLC); 59135
(December 22, 2008), 73 FR 79954 (December 30, 2008) (SR-ISE-2009-
85) (order approving the purchase by ISE Holdings of an ownership
interest in DirectEdge Holdings LLC); and 59281 (January 22, 2009),
74 FR 5014 (January 28, 2009) (SR-NYSE-2008-120) (order approving a
joint venture between NYSE and BIDS Holdings L.P.).
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    The Exchange has proposed four ongoing conditions applicable to
NES's routing activities, which are enumerated above. The Commission
believes that these conditions mitigate its concerns about potential
conflicts of interest and unfair competitive advantage. In particular,
the Commission believes that FINRA's oversight of NES,\27\ combined
with FINRA's monitoring of NES's compliance with the equity trading
rules and quarterly reporting to the Exchange's CRO, will help to
protect the independence of the Exchange's regulatory responsibilities
with respect to NES. The Commission also believes that BX Equity Rule
2140(c) is designed to ensure that NES cannot use any information
advantage it may have because of its affiliation with the Exchange.
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    \27\ This oversight will be accomplished through the 17d-2
Agreement between FINRA and the Exchange and the Regulatory
Contract.
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V. Conclusion

    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\28\ that the proposed rule change (SR-BX-2011-007) be, and hereby
is, approved.
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    \28\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\29\
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    \29\ 17 CFR 200.30-3(a)(12).
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Cathy H. Ahn,
Deputy Secretary.
[FR Doc. 2011-6785 Filed 3-22-11; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 81, Number 244 (Tuesday, December 20, 2016)]
[Notices]
[Pages 92932-92935]
[FR Doc No: 2016-30552]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-79546; File No. SR-NASDAQ-2016-165]

Self-Regulatory Organizations; The NASDAQ Stock Market LLC;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change To
Amend Rule 4770 (Compliance With Regulation NMS Plan To Implement a
Tick Size Pilot)

December 14, 2016.
    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, 2016, The NASDAQ Stock Market LLC (``Nasdaq'' or
``Exchange'') filed with the Securities and Exchange Commission
(``SEC'' or ``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.
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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 proposes to amend Nasdaq Rule 4770 to modify the Web
site data publication requirements relating to the Regulation NMS Plan
to Implement a Tick Size Pilot Program (``Plan'') and to clarify the
timing and format of publishing Market Maker registration statistics.
    The text of the proposed rule change is available on the Exchange's
Web site 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
Statutory Basis for, the Proposed Rule Change

1. Purpose
    On August 25, 2014, Nasdaq, and several other self-regulatory
organizations (the ``Participants'') filed with the Commission,
pursuant to Section 11A of the Act \3\ and Rule 608 of Regulation NMS
thereunder,\4\ the Plan to Implement a Tick Size Pilot Program.\5\ The
Participants filed the Plan to comply with an order issued by the
Commission on June 24, 2014.\6\ The Plan was published for comment in
the Federal Register on November 7, 2014, and approved by the
Commission, as modified, on May 6, 2015.\7\ The Commission approved the
Pilot on a two-year basis, with implementation to begin no later than
May 6, 2016.\8\ On November 6, 2015, the SEC exempted the Participants
from implementing the Pilot until October 3, 2016.\9\ Under the revised
Pilot implementation date, the Pre-Pilot data collection period
commenced on April 4, 2016. On September 13, 2016, the SEC exempted the
Participants from the requirement to fully implement the Pilot on
October 3, 2016, to permit the Participants to implement the pilot on a
phased-in basis, as described in the Participants' exemptive
request.\10\
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    \3\ 15 U.S.C. 78k-1.
    \4\ 17 CFR 242.608.
    \5\ See Letter from Brendon J. Weiss, Vice President,
Intercontinental Exchange, Inc., to Secretary, Commission, dated
August 25, 2014.
    \6\ See Securities Exchange Act Release No 72460 (June 24,
2014), 79 FR 36840 (June 30, 2014).
    \7\ See Securities Exchange Act Release No. 74892 (May 6, 2015),
80 FR 27513 (May 13, 2015) (``Approval Order'').
    \8\ See Approval Order at 27533 and 27545.
    \9\ See Securities Exchange Act Release No. 76382 (November 6,
2015), 80 FR 70284 (November 13, 2015).
    \10\ See Letter from David S. Shillman, Associate Director,
Division of Trading and Markets, Commission, to Eric Swanson, EVP,
General Counsel and Secretary, Bats Global Markets, Inc., dated
September 13, 2016; see also Letter from Eric Swanson, EVP, General
Counsel and Secretary, Bats Global Markets, Inc., to Brent J.
Fields, Secretary, Commission, dated September 9, 2016.
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    The Plan is designed to allow the Commission, market participants,
and the public to study and assess the impact of increment conventions
on the liquidity and trading of the common stock of small-
capitalization companies. Each Participant is required to comply, and
to enforce compliance by its member organizations, as applicable, with
the provisions of the Plan.
    Nasdaq adopted rule amendments to implement the requirements of the
Plan, including relating to the Plan's data collection requirements and
requirements relating to Web site data publication.\11\ Specifically,
with respect to the Web site data publication requirements pursuant to
Section VII and Appendices B and C to the Plan, Nasdaq Rule
4770(b)(2)(B) provides, among other things, that Nasdaq shall make the
data required by Items I and II of Appendix B to the Plan, and
collected pursuant to paragraph (b)(2) of Rule 4770, publicly available
on the Nasdaq Web site on a monthly basis at no charge and shall not
identify the Trading Center that generated the data. Nasdaq Rule
4770(b)(3)(C), provides, among other things, that Nasdaq shall make the
data required by Item IV of Appendix B to the Plan, and collected
pursuant to paragraph (b)(3) of Rule 4770, publicly available on the
Nasdaq Web site on a monthly basis at no charge and shall not identify
the Trading Center that generated the data. Commentary .08 to Rule 4770
provides, among other things, that the requirement that Nasdaq make
certain data publicly available on the Nasdaq Web site pursuant to
Appendix B and C to the Plan shall commence at the beginning of the
Pilot Period.
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    \11\ See, e.g., Securities Exchange Act Release No. 77456 (March
28, 2016), 81 FR 18925 (April 1, 2016) (SR-NASDAQ-2016-043); see
also Letter from David S. Shillman, Associate Director, Division of
Trading and Markets, Commission, to Marcia E. Asquith, Senior Vice
President and Corporate Secretary, FINRA, dated February 17, 2016.
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    Nasdaq is proposing amendments to Rule 4770(b)(2)(B) (regarding
Appendix B.I and B.II data) and Rule 4770(b)(3)(C) (regarding Appendix
B.IV data) to provide that data required to be made available on
Nasdaq's Web site be published within 120 calendar days following month
end. In addition, the proposed amendments to Commentary .08 to Rule
4770 would provide that, notwithstanding the provisions of paragraphs
(b)(2)(B), (b)(3)(C) and (b)(5), Nasdaq shall make data for the Pre-
Pilot period publicly available on the Nasdaq Web site pursuant to
Appendix B and C to the Plan by February 28, 2017.\12\
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    \12\ With respect to data for the Pilot Period, the requirement
that Nasdaq make data publicly available on the Nasdaq Web site
pursuant to Appendix B and C to the Plan shall continue to commence
at the beginning of the Pilot Period. Thus, the first Web site
publication date for Pilot Period data (covering October 2016) would
be published on the Nasdaq Web site by February 28, 2017, which is
120 days following the end of October 2016.
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    The purpose of delaying the publication of the Web site data is to
address confidentiality concerns by providing for the passage of
additional time between the market information reflected in the data
and the public availability of such information.
    Nasdaq also proposes to amend Rule 4770(b)(5), which relates to the
collection and transmission of Market Maker registration statistics.
Currently, Rule 4770(b)(5) provides that the Exchange shall collect and
transmit to the SEC the data described in Item III of Appendix B of the
Plan relating to daily Market Maker registration statistics in a pipe
delimited format within 30 calendar days following month end for (1)
transactions in each Pre-Pilot Data Collection Security for the period
beginning six months prior to the Pilot Period through the trading day
immediately preceding the Pilot Period; and (2) transactions in each
Pilot Security for the period beginning on the first day of the Pilot
Period through six months after the end of the Pilot Period. Although
the Plan requires that such data be made publicly available,\13\ Rule
4770(b)(5) does not currently include a provision requiring the
Exchange to publish such data to its Web site. The Exchange therefore
proposes to amend Rule 4770(b)(5) to provide that the Exchange shall
make Market Maker registration data publicly available on the Exchange
Web site within 120 calendar days following month end at no charge.
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    \13\ See Section VII.A. 4 of the Plan.
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    Nasdaq has filed the proposed rule change for immediate
effectiveness and has requested that the Commission waive the 30-day
operative delay. If the Commission waives the 30-day operative delay,
the operative date of the proposed rule change will be the date of
filing.
2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act,\14\ in general, and furthers the objectives of Section
6(b)(5) of the Act,\15\ 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, because it is designed to assist the Participants in meeting
their regulatory obligations pursuant to the Plan and is in furtherance
of the objectives of the Plan, as identified by the SEC.
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    \14\ 15 U.S.C. 78f(b).
    \15\ 15 U.S.C. 78f(b)(5).
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    In approving the Plan, the Commission recognized that requiring the
publication of Market Maker data may raise confidentiality concerns,
especially for Pilot Securities that may

have a relatively small number of designated Market Makers.\16\ For
this reason, the Commission modified the Plan so that the data that
would be made publicly available would not contain profitability
measures for each security, but would be aggregated by the Control
Group and each Test Group. Nasdaq believes that this proposal is
consistent with the Act in that it is designed to address
confidentiality concerns by permitting Nasdaq to delay Web site
publication to provide for passage of additional time between the
market information reflected in the data and the public availability of
such information. With respect to the change to Rule 4770(b)(5), Nasdaq
believes this change will clarify the timing and format of publishing
Market Maker registration statistics.
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    \16\ See Approval Order at 27543-27544.
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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. Nasdaq notes that the proposed
rule change implements the provisions of the Plan, and is designed to
assist the Participants in meeting their regulatory obligations
pursuant to the Plan.
    The proposal is intended to address confidentiality concerns that
may adversely impact competition, especially for Pilot Securities that
may have a relatively small number of designated Market Makers, by
permitting Nasdaq to delay Web site publication to provide for passage
of additional time between the market information reflected in the data
and the public availability of such information. The proposal also does
not alter the information required to be submitted to the SEC.

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.\17\
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    \17\ Nasdaq notes that Financial Information Forum (FIF)
submitted a letter to the staff of the Commission raising concerns
regarding the publication of certain Appendix B statistics on a
disaggregated basis using a unique masked market participant
identifier. See Letter from Mary Lou Von Kaenel, Managing Director,
FIF, to David S. Shillman, Associate Director, Division of Trading
and Markets, Commission, dated August 16, 2016, available at https://www.fif.com/comment-letters.
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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 \18\ and
subparagraph (f)(6) of Rule 19b-4 thereunder.\19\
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    \18\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \19\ 17 CFR 240.19b-4(f)(6).
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    A proposed rule change filed under Rule 19b-4(f)(6) \20\ normally
does not become operative prior to 30 days after the date of the
filing. However, pursuant to Rule 19b-4(f)(6)(iii),\21\ the Commission
may designate a shorter time if such action is consistent with the
protection of investors and the public interest. In this filing, the
Exchange has asked that the Commission waive the requirement that the
proposed rule change not become operative for 30 days after the date of
the filing.
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    \20\ Id.
    \21\ 17 CFR 240.19b-4(f)(6)(iii).
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    The Exchange notes that the proposed rule change implements the
provisions of the Plan, and is designed to assist the Participants in
meeting their regulatory obligations pursuant to the Plan. The proposal
is intended to address confidentiality concerns by permitting the
Exchange to delay Web site publication to provide for passage of
additional time between the market information reflected in the data
and public availability of such information. The proposal does not
alter the information required to be submitted to the Commission.
    The Commission believes that waiving the 30-day operative delay is
consistent with the protection of investors and the public interest
because it will allow the Exchange to implement these proposed changes
that are intended to address confidentiality concerns. The Commission
notes that some Pilot data was scheduled to be published on November
30, 2016. Therefore, the Commission hereby waives the 30-day operative
delay and designates the proposed rule change to be operative on
November 30, 2016.\22\
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    \22\ For purposes only of waiving the operative delay for this
proposal, the Commission has considered the proposed rule's impact
on efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
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    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-NASDAQ-2016-165 on the subject line.

Paper Comments

 Send paper comments in triplicate to Brent J. Fields,
Secretary, Securities and Exchange Commission, 100 F Street NE.,
Washington, DC 20549-1090.

All submissions should refer to File Number SR-NASDAQ-2016-165. 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-NASDAQ-2016-165 and should be submitted
on or before January 10, 2017.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\23\
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    \23\ 17 CFR 200.30-3(a)(12).
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Robert W. Errett,
Deputy Secretary.
[FR Doc. 2016-30552 Filed 12-19-16; 8:45 am]
 BILLING CODE 8011-01-P


Panel Members:
Matthew J. Arduino, M.S., Dr.P.H., FSHEA, RM(NRCM), M(ASCP)cm
Chief, Clinical and Environmental Microbiology Branch
Centers for Disease Control and Prevention

Joel Bozue, Ph.D.
Bacteriology Division
USAMRIID

Christina Egan, Ph.D.
Chief, Biodefense Laboratory, Wadsworth Center
New York State Department of Health

Lynne M. Sehulster, Ph.D., M (ACSP)
Prevention and Response Branch, Division of Healthcare Quality Promotion
Centers for Disease Control and Prevention

The panel was provided with Industry comments from the industry groups/individuals below:
 Copper Development Association (CDA)
 CuPron
 ASTM
 Antimicrobial Test Labs
 Olin Brass
 Rhonda Jones
Panel members were asked to respond to the comments from the various groups.
Arduino
General Comment: I don't think I'll be changing my responses.  There is a common theme among some of the industry regarding lengthening contact time back to the 2hr in the original protocol and to have a way to show continual activity whether this is done by multiple repeat inoculations or an additional reinoculation at some time point.  I do not have a problem with this.
My main concern with extending the time post inoculation is that the registrants would also account for loss because of the drying of inocula  (remember stainless steel has different surface properties that could influence persistence/survival).
Also I know the copper industry likes to influence others with the DoD clinical trial.  This is one small study (not well controlled and with potential bias).  One small study is not a body of evidence that copper surfaces prevent HAI.  We also believe much to industries dismay that not everything in a patient room would have to be clad in antimicrobial surfaces.
Our thoughts on what would be needed is in the attached editorial [McDonald & Arduino. 2012]
Specific Comments:
 CDA
 Topic- Continuous reduction claim
 Response- I understand why they would want reinoculation of surfaces to show that product continuously works; Would require reinoculation after x period of time from the first experiment;  Would they propose a cleaning step between serial trials?
 Topic- Contact time
 Response- I think contact time might be discted by the controls we know that organisms deposited onto a surface and allowed to dry may have significant loss in viability and the longer the contact time the harder it may be to demonstrate activity based on Cu alone.
 Response- With regards to the DoD study cited (Salgado et al, 2013), while it is a start the study did not address other confounding factors and does not reach the level of evidence needed see McDonald LC, Arduino M.  Editorial commentary: climbing the evidentiary hierarchy for environmental infection control.  Clin Infect Dis. 2013;56(1):36-9 (available from http://cid.oxfordjournals.org/content/56/1/36.long)
 Topic- Concerns regarding 1 hour contact time
 Response- I think other factors begin to play a role when extending out contact time of these is the impact of drying on the survival of the challenge organisms.  There is always some die - off;  other factors also play a role.  These factors include surface characteristics roughness, contact angle, surface charge, hydrophobicity, and relative humidity.
 Topic- DoD Clinical Studies
 Response- There are a number of scientific issues with these studies (including the surface sampling methods; not accounting for confounders, eg. Changes in hand hygiene,; bias etc); one study is not a body of evidence:  the three peer reviewed citations are the same study
 Topic- Testing does not mimic cleaning in hospitals
 Response- It is true that most cleaning in hospitals is daily; with exceptions being for special situations; spills (visible contamination of surfaces with blood or other potentially infectious material).
 Topic- Copper based products and contact time
 Response- Label claims are specified by the manufacturer depending on established contact times for their product; the problem with a two contact time is other factors may influence results.
 Topic- Test antimicrobial resistant strains associated with HAIs
 Response-This is not necessary, AR is not in a traditional sense associated with increased resistance to disinfection.  Tolerance may be seen but this is usually detected with disinfectants below the use-dilution of product.
 Topic- Humidity (RH or AH)
 Shouldn't product be tested under use conditions?  If this is the case the product will be used in "conditioned space" (US hospitals) so humidity levels should reflect at a minimum this RH or AH range.
 ASTM (Mary Bruch)
 Topic- General comment
 Response- Comments are editorial in nature
 Topic- Exposed/unexposed
 Response-Is it possible to use treated and untreated surfaces?
 Topic- 70% alcohol (perhaps better choice is 95-98%)
 Response- Well either way alcohol is not effective against bacterial spores and the optimum antimicrobial activity is between 60 and 80% (it's a bell curve with 70% being the most effective).
 Antimicrobial Test Labs (Diego Ugarte)
 Topic- Abrasion and Chemical Exposure
 Response- Use of a scouring pad may be a way to simulate aging.   Though traditionally these surfaces would not be cleaned with scouring pads but with the wipers that Diego says.
 Topic- Disinfectants
 Response- Some of the products EPA has proposed are commonly encountered in the healthcare setting, having the registrant specify (though they could choose a product based on capability with their product) may not reflect actual use in a healthcare facility where they may choose a single cleaning product for all surfaces.
 Topic- Test Protocol Prior to Finalizing
 Response- This may be a good idea and several people have mentioned this.
 Olin Brass- No additional comments.
 Cupron
 Topic- Remove EDTA\Phosphoric acid as cleaning agents; stick to commonly used products
 Response- Yes these chemicals are not routinely used in healthcare for cleaning purposes;  These have been used in industry for cleaning metal parts (stainless steel, tiles, aluminum, concrete, etc), cleaning of RO membrane.
 Topic- Substitute > for at least
 Response- Agree
 Topic- Remove requests relating to visual appearance of the carrier post-treatment regimen
 Response- Main concern this is not the endpoint, however this may show surface damage.
 Rhonda Jones
 Topic- Intent of protocol
 Response- More of the question as to why non-food contact and whether protocol would be different for food contact surfaces
 Topic- Abrasion cycle time is intensive and costly
 Response- Several people have commented on cost and time of the procedure. Is it possible to reduce to one scrub cycle (1080 passes) and one long chemical exposure?

Bozue: I have read through the various responses and do not feel it necessary to revise my previously submitted answers to the charge questions.

Egan: After careful review of the comments received for review, I do not have the need to change my comments submitted in February.

Sehulster:
General Comment- I read the comments documents provided and determined whether or not they were a match to the main points I raised about the EPA draft lab protocol for assessing antimicrobial potency of copper- and copper-alloy surfaces.  Briefly, I and some of these commenters focused on the issue of needing a lab method to measure continuous potency (the current method revision does not address this).  With regards to the abrasive testing part of the protocol, I can agree with the substitution of a quaternary ammonium compound for the EDTA-phosphoric acid, but I do question the labor-intensive and time-intensive aspects of this part of the protocol.  Two of the reviewers conducted the highly detailed critique of the protocol, raising good questions.  From the information and directives provided to me, I didn't apply that level of scrutiny but rather focused on addressing the general questions posed to us.
Basically, I'll stick with the vast majority of my original comments with the departures noted above and in the attached document.
Specific comments- I will address the comments made by other entities in chronological order from earliest to most recent.
Re: Comments from Ms. Rhonda Jones (no date of submission)
Ms. Jones is commenting on the version of the potency test method released on 09/19/14.  Her first major point of concern is the duration and details (or lack thereof) of the method to evaluate the effects of abrasive action and chemicals.  She raised good questions, asking for clarification and background information.  The revised EPA test protocol of 02/03/15 addresses these questions.  The majority of Ms. Jones' comments are questions about specific details of the method in which she asks for explanations and additional steps to better eliminate process variations among labs.
 Her level of scrutiny is typical for a person who has extensive experience reviewing lab methods for microbial inactivation for registration purposes, and her questions are reasonable.  As for the task presented to me as part of the Letter Review of the revised lab method dated 02/03/15, my sense was that EPA wanted me to respond to general questions about the revision.  Had the agency's instructions for the Letter Review indicated that EPA wanted a step-by-step critique of the revised method, I would have done that.  My comments and questions would have aligned with those of Ms. Jones on the details.  However, I made a mental note that the agency appeared to be moving away from exquisitely detailed protocols, thereby allowing some room for process variation.  The lab technician, however, would have to make note of all the details done in some of the steps for EPA review and documentation.
Re: Comments from Dr. Mary Bruch (no date of submission)
Dr. Bruch is commenting on the version of the potency test method released on 09/19/14.  Her comments to the agency are similar to those of Ms. Jones, concentrating on detailed information needed for various steps in the protocol, with some editorial comments.  Dr. Bruch also has extensive experience in providing method reviews that are highly detailed and specific.  She raises an interesting point of discussion about "surface products" or "product surfaces."  The EPA revised method of 02/03/15 does not appear to comment on this question.
My statement that the 02/06/15 method appears to be reasonable is made with the awareness that several of the steps in the revised method could be more detailed, but my sense is that the agency is allowing some lab variation on some of the steps so long as the lab provides the agency with the details about said variations.  If my assumption is wrong, then yes  -  the method details as pointed out by these two reviewers should be addressed by the agency.
Re: Comments from Mr. Alastair Monk
Mr. Monk discusses a few major items in his comments.  The first point is the number and identity of the challenge microorganisms (he recommends only two, these being Staphylococcus aureus and Pseudomonas aeruginosa).  In my opinion, I view the agency's recommended challenge microorganisms of S. aureus, P. aeruginosa, and Enterobacter aerogenes to be appropriate selections for this reason  -  these bacteria are representative of bacteria commonly found on skin (S. aureus), bacteria found in water (P. aeruginosa), and bacteria found in fecal matter (E. aerogenes).  This selection covers the three main sources of contaminated reservoirs we would most likely encounter in settings where copper- and copper alloy fixtures and surfaces would be used for infection prevention.  Mr. Monk does make two good points about the abrasive test, saying that there should be a dry version and a wet version of the test, and a representative quaternary ammonium compound should be used in place of EDTA-phosphoric acid as one of the chemicals.  In concept, I would support these suggestions, but other reviewers have commented that in their opinion the abrasive testing phase of the overall test protocol is both labor- and time-burdensome.  With regards to contact time, Mr. Monk supports the two-hour exposure period, so he doesn't appear to comment on the notion of continuous potency.
 Re: Comments from Mr. Andrew Kireta (CDA)
Mr. Kireta's two major points of discussion are the following: 1) the need to demonstrate continuous inactivation of microbes by copper and copper alloys; and 2) the need for the agency to gear up for validation testing of the protocol via intra-lab studies and inter-lab comparative studies.  My previous submission of comments to EPA centered on these two points as well.  Knowing the EPA laboratory professionals, I'm confident that the agency will pursue validation studies on this or any testing method they promote for regulatory purposes.  With regards to the issue of continuous potency, I have not seen any earlier version of the protocol in which this topic may have been considered, but a test does need to be developed to support any claim for continuous potency.
Re: Comments from Mr. Diego Ugarte
Mr. Ugarte joins the other commenters in his questions about the abrasive test.  He basically asks about the rationale for the agency's selection of chemicals and experimental design points, and what happens from a registration viewpoint when a test lab misses the requisite number of test runs.  If EPA produces another revision to this method, responses to Mr. Ugarte's questions would be very helpful not only to him but to all the laboratorians who will be thinking of offering this testing to their clients for product registration.
Re: Comments from Mr. Kon John (Olin Brass)
Mr. John basically wants to keep the status quo.
Re: Comments from Mr. Joseph Green (CDA)
Mr. Green corroborates the earlier comment from his colleague Mr. Kireta regarding the issue of demonstrating continuous potency.  As I mentioned in my comments on the protocol and repeated elsewhere in this document, a validated lab method must be developed (if one doesn't already exist) in order to generate those data in support of a continual inactivation claim.  The lab test protocol dated 02/03/15 does not achieve this objective, as it clearly indicates a contact of two hours.


[Federal Register Volume 88, Number 111 (Friday, June 9, 2023)]
[Notices]
[Page 37890]
[FR Doc No: 2023-12293]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-3343]

Advisory Committee; Dermatologic and Ophthalmic Drugs Advisory
Committee; Renewal

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; renewal of Federal advisory committee.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
renewal of the Dermatologic and Ophthalmic Drugs Advisory Committee by
the Commissioner of Food and Drugs (the Commissioner). The Commissioner
has determined that it is in the public interest to renew the
Dermatologic and Ophthalmic Drugs Advisory Committee for an additional
2 years beyond the charter expiration date. The new charter will be in
effect until the October 7, 2024, expiration date.

DATES: Authority for the Dermatologic and Ophthalmic Drugs Advisory
Committee will expire on October 7, 2024, unless the Commissioner
formally determines that renewal is in the public interest.

FOR FURTHER INFORMATION CONTACT: LaToya Bonner, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301-
796-2855, [email protected].

SUPPLEMENTARY INFORMATION: Pursuant to 41 CFR 102-3.65 and approval by
the Department of Health and Human Services and by the General Services
Administration, FDA is announcing the renewal of the Dermatologic and
Ophthalmic Drugs Advisory Committee (the Committee). The Committee is a
discretionary Federal advisory committee established to provide advice
to the Commissioner. The Committee advises the Commissioner or designee
in discharging responsibilities as they relate to helping to ensure
safe and effective drugs for human use and, as required, any other
product for which FDA has regulatory responsibility.
    The Committee reviews and evaluates available data concerning the
safety and effectiveness of marketed and investigational human drug
products for use in the treatment of dermatologic and ophthalmic
disorders and makes appropriate recommendations to the Commissioner.
    The Committee shall consist of a core of nine voting members
including two Chairpersons. Members and the Chairpersons are selected
by the Commissioner or designee from among authorities knowledgeable in
the fields of dermatology, ophthalmology, internal medicine, pathology,
immunology, epidemiology or statistics, and other related professions.
Members will be invited to serve for overlapping terms of up to 4
years. Non-Federal members of this committee will serve as Special
Government Employees, representatives or Ex-Officio members. Federal
members will serve as Regular Government Employees or Ex-Officios. The
core of voting members may include one technically qualified member,
selected by the Commissioner or designee, who is identified with
consumer interests and is recommended by either a consortium of
consumer-oriented organizations or other interested persons. In
addition to the voting members, the Committee may include one non-
voting representative member who is identified with industry interests.
There may also be an alternate industry representative.
    Further information regarding the most recent charter and other
information can be found at https://www.fda.gov/advisory-committees/dermatologic-and-ophthalmic-drugs-advisory-committee/dermatologic-and-ophthalmic-drugs-advisory-committee-charter or by contacting the
Designated Federal Officer (see FOR FURTHER INFORMATION CONTACT). In
light of the fact that no change has been made to the committee name or
description of duties, no amendment will be made to 21 CFR 14.100.
    This notice is issued under the Federal Advisory Committee Act (5
U.S.C. app.). For general information related to FDA advisory
committees, please visit us at https://www.fda.gov/AdvisoryCommittees/default.htm.

    Dated: June 5, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-12293 Filed 6-8-23; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 77, Number 43 (Monday, March 5, 2012)]
[Notices]
[Pages 13120-13121]
[FR Doc No: 2012-5232]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket Nos. EL12-36-000; QF89-25-008]

Morgantown Energy Associates; Notice of Petition for Enforcement

    Take notice that on February 24, 2012, Morgantown Energy Associates
(MEA) filed a Petition for Enforcement, pursuant to section
210(h)(2)(B) of the Public Utility Regulatory Policies Act of 1978
(PURPA), requesting that the Federal Energy Regulatory Commission
(Commission) initiate enforcement action against the Public Service
Commission of West Virginia (PSC), because of the PSC's issuance of an
order on November 22, 2011.\1\ MEA argues that the ruling in the PSC
Order is contrary to PURPA.
---------------------------------------------------------------------------

    \1\ Monongahela Power Co. and The Potomac Edison Co., both dba
Allegheny Power, Case No. 11-0249-E-P (Pub. Serv. Comm'n of W. Va.,
Nov. 22, 2011). (PSC Order)
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    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of

the Commission's Rules of Practice and Procedure (18 CFR 385.211,
385.214). Protests 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. Any person wishing to become a
party must file a notice of intervention or motion to intervene, as
appropriate. Such notices, motions, or protests must be filed on or
before the comment date. On or before the comment date, it is not
necessary to serve motions to intervene or protests on persons other
than the Applicant
    The Commission encourages electronic submission of protests and
interventions 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 or intervention 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 email
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern Time on March 16, 2012.

    Dated: February 28, 2012.
Kimberly D. Bose,
Secretary.
[FR Doc. 2012-5232 Filed 3-2-12; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 81, Number 39 (Monday, February 29, 2016)]
[Notices]
[Page 10256]
[FR Doc No: 2016-04277]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-2126]

Agency Information Collection Activities; Announcement of Office
of Management and Budget Approval; Food and Drug Administration's
Research and Evaluation Survey for the Public Education Campaign on
Tobacco Among LGBT (RESPECT)

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a
collection of information entitled ``Food and Drug Administration's
Research and Evaluation Survey for the Public Education Campaign on
Tobacco among LGBT (RESPECT)'' has been approved by the Office of
Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: On January 26, 2016, the Agency submitted a
proposed collection of information entitled ``Food and Drug
Administration's Research and Evaluation Survey for the Public
Education Campaign on Tobacco among LGBT (RESPECT)'' to OMB for review
and clearance under 44 U.S.C. 3507. An Agency may not conduct or
sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB control number.
OMB has now approved the information collection and has assigned OMB
control number 0910-0808. The approval expires on January 31, 2019. A
copy of the supporting statement for this information collection is
available on the Internet at http://www.reginfo.gov/public/do/PRAMain.
    April 4, 2016

    Dated: February 23, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-04277 Filed 2-26-16; 8:45 am]
 BILLING CODE 4164-01-P