[Federal Register: February 17, 2009 (Volume 74, Number 30)]
[Notices]
[Page 7447-7448]
[DOCID:fr17fe09-88]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0012]

International Conference on Harmonisation; Draft Guidance on Q4B
Evaluation and Recommendation of Pharmacopoeial Texts for Use in the
International Conference on Harmonisation Regions; Dissolution Test
General Chapter; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance entitled ``Q4B Evaluation and
Recommendation of Pharmacopoeial Texts for Use in the ICH Regions;
Annex 7: Dissolution Test General Chapter.'' The draft guidance was
prepared under the auspices of the International Conference on
Harmonisation of Technical Requirements for Registration of
Pharmaceuticals for Human Use (ICH). The draft guidance provides the
results of the ICH Q4B evaluation of the Dissolution Test General
Chapter harmonized text from each of the three pharmacopoeias (United
States, European, and Japanese) represented by the Pharmacopoeial
Discussion Group (PDG). The draft guidance conveys recognition of the
three pharmacopoeial methods by the three ICH regulatory regions and
provides specific information regarding the recognition. The draft
guidance is intended to recognize the interchangeability between the
local regional pharmacopoeias, thus avoiding

redundant testing in favor of a common testing strategy in each
regulatory region. This draft guidance is the seventh annex to the core
Q4B guidance, which was made available in the Federal Register of
February 21, 2008 (73 FR 9575).

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this draft guidance before it begins work on the final version of the
guidance, submit written or electronic comments on the draft guidance
by April 20, 2009.

ADDRESSES: Submit written requests for single copies of this draft
guidance to the Division of Drug Information, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD 20993-0002; or
the Office of Communication, Training and Manufacturers Assistance
(HFM-40), Center for Biologics Evaluation and Research (CBER), Food and
Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD
20852-1448. The guidance may also be obtained by mail by calling CBER
at 1-800-835-4709 or<PHONE_NUMBER>. Send two self-addressed adhesive
labels to assist the office in processing your requests. Submit written
comments on the draft guidance to the Division of Dockets Management
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. Submit electronic comments to http://
www.regulations.gov. See the SUPPLEMENTARY INFORMATION section for
electronic access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT:
    Regarding the guidance:Robert H. King, Sr., Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 4150, Silver Spring, MD 20993-0002, 301-
796-1242;or
    Christopher Joneckis, Center for Biologics Evaluation and Research
(HFM-25), Food and Drug Administration, 1401 Rockville Pike, suite
200N, Rockville, MD 20852-1448,<PHONE_NUMBER>.
    Regarding the ICH: Michelle Limoli, Office of International
Programs (HFG-1), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance entitled
``Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in
the ICH Regions; Dissolution Test General Chapter.'' In recent years,
many important initiatives have been undertaken by regulatory
authorities and industry associations to promote international
harmonization of regulatory requirements. FDA has participated in many
meetings designed to enhance harmonization and is committed to seeking
scientifically based harmonized technical procedures for pharmaceutical
development. One of the goals of harmonization is to identify and then
reduce differences in technical requirements for drug development among
regulatory agencies.
    ICH was organized to provide an opportunity for tripartite
harmonization initiatives to be developed with input from both
regulatory and industry representatives. FDA also seeks input from
consumer representatives and others. ICH is concerned with
harmonization of technical requirements for the registration of
pharmaceutical products among three regions: The European Union, Japan,
and the United States. The six ICH sponsors are the European
Commission; the European Federation of Pharmaceutical Industries
Associations; the Japanese Ministry of Health, Labour, and Welfare; the
Japanese Pharmaceutical Manufacturers Association; the Centers for Drug
Evaluation and Research and Biologics Evaluation and Research, FDA; and
the Pharmaceutical Research and Manufacturers of America. The ICH
Secretariat, which coordinates the preparation of documentation, is
provided by the International Federation of Pharmaceutical
Manufacturers Associations (IFPMA).
    The ICH Steering Committee includes representatives from each of
the ICH sponsors and the IFPMA, as well as observers from the World
Health Organization, Health Canada, and the European Free Trade Area.
    In November 2008, the ICH Steering Committee agreed that a draft
guidance entitled ``Q4B Evaluation and Recommendation of Pharmacopoeial
Texts for Use in the ICH Regions; Annex 7: Dissolution Test General
Chapter'' should be made available for public comment. The draft
guidance is the product of the Q4B Expert Working Group of the ICH.
Comments about this draft will be considered by FDA and the Q4B Expert
Working Group.
    The draft guidance provides the specific evaluation results from
the ICH Q4B process for the Dissolution Test General Chapter
harmonization proposal originating from the three-party PDG. This draft
guidance is in the form of an annex to the core ICH Q4B guidance. Once
finalized, the annex will provide guidance to assist industry and
regulators in the implementation of the specific topic evaluated by the
ICH Q4B process.
    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 agency's current thinking on Q4B
Evaluation and Recommendation of Pharmacopoeial Texts for Use in the
ICH Regions; Dissolution Test General Chapter. It does not create or
confer any rights for or on any person and does not operate to bind FDA
or the public. An alternative approach may be used if such approach
satisfies the requirements of the applicable statutes and regulations.

II. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this document.
Submit a single copy of electronic comments or two paper copies of any
mailed comments, except that individuals may submit one paper copy.
Comments are to be identified with the docket number found in brackets
in the heading of this document. Received comments may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.

III. Electronic Access

    Persons with access to the Internet may obtain the document at
http://www.regulations.gov, http://www.fda.gov/cder/guidance/index.htm,
or http://www.fda.gov/cber/guidelines.htm.

    Dated: February 6, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-3169 Filed 2-13-09; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register Volume 79, Number 184 (Tuesday, September 23, 2014)]
[Rules and Regulations]
[Pages 56654-56655]
[FR Doc No: 2014-22588]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2014-0761]

Drawbridge Operation Regulation; Middle River, Between Bacon
Island and Lower Jones Tract, CA

AGENCY: Coast Guard, DHS.

ACTION: Notice of deviation from drawbridge regulation.

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SUMMARY: The Coast Guard has issued a temporary deviation from the
operating schedule that governs the Bacon Island Road Drawbridge across
Middle River, mile 8.6, between Bacon Island and Lower Jones Tract, CA.
The deviation is necessary to allow the bridge owner to perform
structural maintenance work to the bridge. This deviation allows the
bridge to remain in the closed-to-navigation position during the
deviation period.

DATES: This deviation is effective without actual notice from September
23, 2014 through 5 p.m. on October 23, 2014. For the purposes of
enforcement, actual notice will be used from 9 a.m. on September 8,
2014, until September 23, 2014.

ADDRESSES: The docket for this deviation, [USCG-2014-0761], is
available at http://www.regulations.gov. Type the docket number in the
``SEARCH'' box and click ``SEARCH.'' Click on Open Docket Folder on the
line associated with this deviation. You may also visit the Docket
Management Facility in Room W12-140 on the ground floor of the
Department of Transportation West Building, 1200 New Jersey Avenue SE.,
Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this
temporary deviation, call or email David H. Sulouff, Chief, Bridge
Section, Eleventh Coast Guard District; telephone<PHONE_NUMBER>, email
<EMAIL_ADDRESS>If you have questions on viewing the docket,
call Cheryl Collins, Program Manager, Docket Operations, telephone 202-
366-9826.

SUPPLEMENTARY INFORMATION: San Joaquin County Department of Public
Works has requested a temporary change to the operation of the Bacon
Island Road Drawbridge, mile 8.6, over Middle River, between Bacon
Island and Lower Jones Tract, CA. The drawbridge navigation span
provides approximately 8 feet vertical clearance above Mean High Water
in the closed-to-navigation position. In accordance with 33 CFR
117.171(a), the draw opens on signal from May 15 through September 15
from 9 a.m. to 5 p.m. From September 16 through May 14, the draw opens
on signal from 9 a.m. to 5 p.m. from Thursday through Monday. At all
other times, the draw shall open on signal if at least 12 hours notice
is given to the San Joaquin County Department of Public Works at
Stockton. Navigation on the waterway is commercial and recreational.
    The drawspan will be secured in the closed-to-navigation position
from 9 a.m. on September 8, 2014 to 5 p.m. on October 23, 2014, due to
structural maintenance work in replacing the approach deck slabs. The
work will require loss of power to the bridge electrical systems. This
temporary deviation has been coordinated with the waterway users. No
objections to the proposed temporary deviation were raised.
    Vessels able to pass through the bridge in the closed position may
do so at any time. The bridge will not be able to open for emergencies.
Old River can be used as an alternate route for vessels unable to pass
through the bridge in the closed position. The Coast Guard will inform
waterway users of this temporary deviation via our Local and Broadcast
Notices to Mariners, to minimize resulting navigational impacts.
    In accordance with 33 CFR 117.35(e), the drawbridge must return to
its regular operating schedule immediately at the end of the effective
period of this temporary deviation. This deviation from the operating
regulations is authorized under 33 CFR 117.35.

    Dated: September 4, 2014.
D.H. Sulouff,
District Bridge Chief, Eleventh Coast Guard District.
[FR Doc. 2014-22588 Filed 9-22-14; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register: September 8, 2010 (Volume 75, Number 173)]
[Rules and Regulations]
[Page 54492-54493]
[DOCID:fr08se10-6]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 524

[Docket No. FDA-2010-N-0002]

Ophthalmic and Topical Dosage Form New Animal Drugs; Gentamicin
and Betamethasone Ophthalmic Solution

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Final rule; technical amendment.

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SUMMARY:  The Food and Drug Administration (FDA) is amending the animal
drug regulations to codify the conditions of use of an approved new
animal drug application (NADA) for gentamicin sulfate and betamethasone
acetate ophthalmic solution. This action is being taken to comply with
the Federal Food, Drug, and Cosmetic Act and to improve the accuracy of
the regulations.

DATES: This rule is effective September 8, 2010.

FOR FURTHER INFORMATION CONTACT:  Melanie R. Berson, Center for
Veterinary Medicine (HFV-110), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855,<PHONE_NUMBER>, email:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: FDA has noticed that the approved conditions
of use for GENTOCIN DURAFILM (gentamicin sulfate and betamethasone
acetate) Ophthalmic Solution, sponsored by Intervet, Inc., 56
Livingston Ave., Roseland, NJ 07068 under NADA 34-267 are not codified.
When this NADA was approved in 1967, codification of approved
conditions of use for NADAs was not required. Accordingly, the
regulations are amended in 21 CFR part 524 by adding Sec.  524.1044i to
reflect the approval. This action is being taken to comply with section
512(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(i))
and to improve the accuracy of the regulations.
    This rule does not meet the definition of ``rule'' in 5 U.S.C.
804(3)(A) because it is a rule of ``particular applicability.''
Therefore, it is not subject to the congressional review requirements
in 5 U.S.C. 801-808.

List of Subjects in 21 CFR Part 524

    Animal drugs.

0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs and
redelegated to the Center for Veterinary Medicine, 21 CFR part 524 is
amended as follows:

PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS

0
1. The authority citation for 21 CFR part 524 continues to read as
follows:

    Authority: 21 U.S.C. 360b.

0
2. Add Sec.  524.1044i to read as follows:

Sec.  524.1044i  Gentamicin and betamethasone ophthalmic solution.

    (a) Specifications. Each milliliter (mL) of solution contains
gentamicin sulfate equivalent to 3 milligrams (mg) of gentamicin base
and 1 mg

betamethasone acetate equivalent to 0.89 mg betamethasone alcohol.
    (b) Sponsor. See No. 000061 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. Instill one or two drops
of solution in the conjunctival sac three or four times a day.
    (2) Indications for use. For treatment of external bacterial
infections of the eye (conjunctiva and cornea).
    (3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.

    Dated: September 1, 2010.
Elizabeth Rettie,
Deputy Director, Office of New Animal Drug Evaluation, Center for
Veterinary Medicine.
[FR Doc. 2010-22276 Filed 9-7-10; 8:45 am]
BILLING CODE 4160-01-S


[Federal Register Volume 76, Number 166 (Friday, August 26, 2011)]
[Notices]
[Pages 53503-53505]
[FR Doc No: 2011-21854]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-65175; File No. SR-BX-2011-057]

Self-Regulatory Organizations; NASDAQ OMX BX, Inc.; Notice of
Filing and Immediate Effectiveness of Proposed Rule Change To Establish
and Adopt Fees for the New BX Pre-Trade Risk Management Service

August 19, 2011.
    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 August 16, 2011, NASDAQ OMX BX, Inc. (the ``Exchange'') filed
with the Securities and Exchange Commission (``Commission'') the
proposed rule change as described in Items I and II below, which Items
have been prepared by the Exchange. The Commission is publishing this
notice to solicit comments on the proposed rule change from interested
persons.
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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 establish and adopt fees for the new BX
Pre-Trade Risk Management service (``PRM''). The Exchange will
implement the fee effective September 1, 2011.
    The text of the proposed rule change is below. Proposed new
language is in

italics; proposed deletions are in brackets.
* * * * *

7016. [Reserved] BX Pre-Trade Risk Management

(a) Users of BX Pre-trade Risk Management (``PRM'') will be assessed
a monthly fee based on the following table, and such fees will not
exceed $25,000 per member firm, per month:

----------------------------------------------------------------------------------------------------------------
                                          Number of PRM-enabled
              Port tiers                          ports                             Monthly fee
----------------------------------------------------------------------------------------------------------------
Tier 1................................  50 or more...............  $400 per port, per month.
Tier 2................................  20 to 49.................  $500 per port, per month.
Tier 3................................  5 to 19..................  $550 per port, per month.
Tier 4................................  1 to 4...................  $600 per port, per month.
----------------------------------------------------------------------------------------------------------------

    (b) Users of PRM services specified below will be assessed the
following charges in addition to the applicable PRM-enabled port
charges:

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

------------------------------------------------------------------------
PRM Modules............................  No charge.
Aggregate Total Checks.................  No charge.
PRM Workstation Add-ons to an existing   $100 per each PRM Workstation
 Workstation or WeblinkACT 2.0.           Add-on per month.
------------------------------------------------------------------------

* * * * *

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 is proposing to adopt BX Pre-trade Risk Management
under Rule 7016. PRM provides member firms with the ability to set a
wide range of parameters for orders to facilitate pre-trade protection
by creating a PRM module defined to represent checks desired. Using
PRM, member firms can increase controls on their trading activity and
the trading activity of their clients and customers at the order level,
including the opportunity to prevent potentially erroneous
transactions. PRM validates orders entered on PRM-enabled ports prior
to allowing those orders into its matching engine and, using parameters
set by the subscriber, determines if the order should be sent for
fulfillment. If PRM rejects an order, it alerts the member firm and
provides it with clearly-defined reasons for the rejection.\3\ These
alerts are sent on Execution and Order/Message DROP copy lines/reports.
The Exchange believes that PRM will be a useful tool to assist members
in complying with the Commission's new market access rule \4\ and
related Exchange requirements.
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    \3\ For example, PRM provides a ``Fat Finger Check,'' which
allows a user to compare price instructions on incoming orders
against the current displayed size and price in the market. If the
order is not in line with the displayed price and size, the order
will be rejected before it can execute. Users can set order limits
at several levels to ensure that clearly erroneous orders never
execute.
    \4\ 17 CFR 240.15c3-5. See Securities Exchange Act Release No.
63241 (November 3, 2010), 75 FR 69792 (November 15, 2010).
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    PRM users may choose to set PRM Order Checks, Aggregate Total
Checks within a PRM Module, and subscribe to PRM Workstation Add-ons to
an existing Workstation or WeblinkACT 2.0. PRM manages risk by checking
each order, before it is accepted into the system, against certain
parameters pre-specified by the user within a module, such as maximum
order size or value, order type restrictions, market session
restrictions (pre/post market), security restrictions, including per-
security limits, restricted stock list, and certain other criteria.
These checks are in addition to the Fat Finger Check, which is
available for all orders submitted through a RASH/FIX PRM-enabled
port.\5\ In order for a member firm to subscribe, at least one PRM
Module per market participant ID (``MPID'') is required, but a user may
have multiple PRM Module subscriptions per MPID, depending on the type
and number of ports designated as PRM ports.\6\ A PRM Module is created
to validate individual orders against pre-specified parameters.
Aggregate Total Checks allow users to limit overall daily trading
activity based on Buy, Sell, and/or Net trading limits. These daily
trading activity limits may be established at an aggregate limit and/or
security specific limit per PRM Module. Member firms may subscribe to
the PRM Workstation Add-on to an existing Workstation or WeblinkACT 2.0
for a fee.
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    \5\ Id.
    \6\ A member firm using FIX or Rash ports can configure its PRM
Module to pre-trade-manage a subscriber's order flow for a specified
MPID and PRM-enabled port, or for an account within an MPID. A
member using OUCH ports can configure its PRM Module to pre-trade-
manage a subscriber's order flow for a specified port.
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    The Exchange is proposing to assess a per-port fee for PRM under
Rule 7016(a). This monthly port-based fee is tiered, decreasing as the
number of PRM-enabled ports subscribed increase and the next tier is
reached. The Exchange is also proposing to limit the fees assessed a
member firm under the tiered fee structure to a total of $25,000 per
month. Rule 7016(b) sets forth fees assessed for PRM Modules and
Aggregate Total Check, which will be available to subscribers at no
cost, and a monthly fee of $100 per each PRM Workstation Add-on to an
existing Workstation or WeblinkACT 2.0 per month.
    The NASDAQ Stock Market (``NASDAQ'') has offered Pre-trade Risk
Management to its members for many years, and the Exchange is now
proposing to offer member firms the identical service offered at the
same fee levels.\7\ A member firm that is an existing subscriber of
NASDAQ PRM, however, must subscribe separately to BX PRM to receive the
service for its Exchange order flow.
---------------------------------------------------------------------------

    \7\ The Exchange notes that NASDAQ recently amended the fees
assessed for PRM and its services. See Securities Exchange Act
Release No. 65020 (August 3, 2011), 76 FR 48193 (August 8, 2011)
(SR-NASDAQ-2011-099).

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2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with Section 6(b)(4) of the Act \8\ in that it provides for the
equitable allocation of reasonable dues, fees and other charges among
members and issuers and other persons using any facility or system
which the Exchange operates or controls, and it does not unfairly
discriminate between customers, issuers, brokers or dealers. The new
PRM fee schedule applies to all subscribers equally based on the number
of ports subscribed. The proposed fees will cover the costs associated
with separately offering the service, responding to customer requests,
configuring Exchange systems, programming to user specifications, and
administering the service, among other things, and may provide the
Exchange with a profit to the extent costs are covered.
---------------------------------------------------------------------------

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

    The Exchange also believes that the proposed rule change is
consistent with the provisions of Section 6(b)(5) of the Act \9\
because it is designed to prevent fraudulent and manipulative acts and
practices, to promote just and equitable principles of trade, to foster
cooperation and coordination with persons engaged in facilitating
transactions in securities, and to remove impediments to and perfect
the mechanism of a free and open market and a national market system.
PRM is designed to assist member firms in avoiding entry of erroneous
orders by screening out those that exceed pre-determined limits, which
otherwise may harm both the member firm and the quality of the markets.
As such, PRM is an important compliance tool that members may use to
help maintain the regulatory integrity of the markets.
---------------------------------------------------------------------------

    \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
result in any burden on competition that is not necessary or
appropriate in furtherance of the purposes of the Act, as amended.

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

    Written comments were neither solicited nor received.

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

    Because the foregoing proposed rule change does not significantly
affect the protection of investors or the public interest, does not
impose any significant burden on competition, and, by its terms, does
not 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) of the Act \10\ and Rule 19b-
4(f)(6) thereunder.\11\
---------------------------------------------------------------------------

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

    The Exchange has requested that the Commission waive the 30-day
operative delay. The Commission believes that waiver of the operative
delay is consistent with the protection of investors and the public
interest. Such a waiver will allow the Exchange to offer the PRM
service, which a member may use as a tool that could assist compliance
with certain regulatory obligations and enhance market integrity, as
soon as possible. Accordingly, the Commission designates the proposal
operative upon filing.\12\
---------------------------------------------------------------------------

    \12\ For purposes only of waiving the 30-day operative delay,
the Commission has considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act.

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 e-mail to<EMAIL_ADDRESS>Please include
File Number SR-BX-2011-057 on the subject line.

Paper Comments

     Send paper comments in triplicate to Elizabeth M. Murphy,
Secretary, Securities and Exchange Commission, 100 F Street, NE.,
Washington, DC 20549-1090.

All submissions should refer to File Number SR-BX-2011-057. This file
number should be included on the subject line if e-mail 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
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. 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-BX-2011-057 and should be
submitted on or before September 16, 2011.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\13\
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    \13\ 17 CFR 200.30-3(a)(12).
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Elizabeth M. Murphy,
Secretary.
[FR Doc. 2011-21854 Filed 8-25-11; 8:45 am]
BILLING CODE 8011-01-P