[Federal Register Volume 79, Number 93 (Wednesday, May 14, 2014)]
[Notices]
[Pages 27622-27623]
[FR Doc No: 2014-11053]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-0234]

Draft Guidance for Industry on Clinical Pharmacology Data To
Support a Demonstration of Biosimilarity to a Reference Product;
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availability of a draft guidance for industry entitled ``Clinical
Pharmacology Data to Support a Demonstration of Biosimilarity to a
Reference Product.'' This guidance is intended to assist sponsors in
developing a clinical pharmacology program to support a decision that a
proposed therapeutic biological product is biosimilar to, that is not
clinically meaningfully different from, its reference product.
Specifically, the guidance discusses some of the overarching concepts
related to clinical pharmacology studies for biosimilar products,
approaches for developing the appropriate clinical pharmacology
database, and the utility of modeling and simulation for designing
clinical trials. This draft guidance is one in a series of guidances
that FDA is developing to implement the Biologics Price Competition and
Innovation Act of 2009 (BPCI Act).

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draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by August 12, 2014.

ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information, Center for Drug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, 10903 New
Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD 20993-0002, or
Office of Communication, Outreach, and Development (HFM-40), Center for
Biologics Evaluation and Research, Food and Drug Administration, 1401
Rockville Pike, Rockville, MD 20852-1448. 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draft guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Sandra Benton, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6340, Silver Spring, MD 20993-0002, 301-
796-2500, email<EMAIL_ADDRESS>or Stephen Ripley, Center
for Biologics Evaluation and Research (HFM-17), Food and Drug
Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-
1448,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Clinical Pharmacology Data to Support a Demonstration of
Biosimilarity to a Reference Product.'' Clinical pharmacology studies
are part of a stepwise approach to develop the data and information
needed to support a demonstration of biosimilarity. Adequate and well-
conducted clinical pharmacology studies can address the residual
uncertainty in biosimilarity assessment from clinical perspectives and
inform the design of subsequent studies to assess clinically meaningful
differences between the biosimilar and the reference products. The
draft guidance discusses some critical considerations related to
clinical pharmacology testing for biosimilar products, approaches for
developing the appropriate clinical pharmacology database, and the
utility of modeling and simulation for designing clinical trials. In
its description of how to design and use clinical pharmacology studies
to add to the totality of evidence that a proposed biological product
is biosimilar to its reference product, the draft guidance is meant to
assist sponsors in designing such studies in support of applications
submitted under section 351(k) of the Public Health Service Act (42
U.S.C. 262(k)). Scientific principles described in the draft guidance
may also be informative for the development of certain biological
products under section 505(b)(2) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355).
    This draft guidance is one in a series that FDA is developing to
implement the BPCI Act and 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 this topic.
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. The Paperwork Reduction Act of 1995

    The draft guidance refers to previously approved collections of
information that are subject to review by the Office of Management and
Budget under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
The collection of information submitted under section 351(k)
applications for biosimilars is approved under OMB control number 0910-
0719. The collection of information submitted under 21 CFR part 312 is
approved under OMB control number 0910-0014.

III. Comments

    Interested persons may submit either electronic comments regarding
the draft guidance to http://www.regulations.gov or written comments to
the Division of Dockets Management (see ADDRESSES). It is only
necessary to send one set of comments. Identify comments with the
docket number found in brackets in the heading of this document.
Received comments may be seen in the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to
the docket at http://www.regulations.gov.

IV. Electronic Access

    Persons with access to the Internet may obtain the draft guidance
at either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://
www.fda.

gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/
default.htm, or http://www.regulations.gov.

    Dated: May 8, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-11053 Filed 5-13-14; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 79, Number 56 (Monday, March 24, 2014)]
[Notices]
[Pages 16094-16095]
[FR Doc No: 2014-06359]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Twenty-Third Meeting: RTCA Special Committee 216, Aeronautical
Systems Security (Joint Meeting With EUROCAE WG-72)

AGENCY: Federal Aviation Administration (FAA), U.S. Department of
Transportation (DOT).

ACTION: Meeting Notice of RTCA Special Committee 216, Aeronautical
Systems Security (Joint Meeting with EUROCAE WG-72).

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SUMMARY: The FAA is issuing this notice to advise the public of the
twenty-third meeting of RTCA Special Committee 216, Aeronautical
Systems Security (Joint Meeting with EUROCAE WG-72).

DATES: The meeting will be held April 8-9, 2014 from 9:00 a.m.-5:00
p.m. but ending at 3:00 p.m. on the last day.

ADDRESSES: The meeting will be held at RTCA Headquarters, 1150 18th
Street NW., Suite 910, Washington, DC 20036.

FOR FURTHER INFORMATION CONTACT: You may contact the RTCA Secretariat,
1150 18th Street NW., Suite 910, Washington, DC 20036, or by telephone
at<PHONE_NUMBER>, fax at<PHONE_NUMBER>, or Web site http://www.rtca.org for directions.

SUPPLEMENTARY INFORMATION: Pursuant to section 10(a)(2) of the Federal
Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.), notice is
hereby given for a meeting of Special Committee 216.
    This important plenary meeting will start at 9:00 a.m. on the first
day and to finish by 5:00 p.m. on the last day.
    The main purpose of the meeting is to finalize disposition of any
remaining public comments from the FRAC period on revised ED-202/DO-326
and ED-

204/DO-yy4, and to hold a committee vote on whether these two documents
are ready for publication.
    Eurocae WG-72 will meet simultaneously in Europe and hold their own
vote. The two committees intend to communicate via teleconference
during the meeting to ensure coordination.
    Logistical information: Directions and Hotel information for RTCA
is located on the Web site--http://www.rtca.org--Directions to RTCA.
    RSVP: Please inform Derek Schatz (derek.p.schatz@boeing.com), Dan
Johnson (daniel.p.johnson@honeywell.com), or Chuck Royalty
<EMAIL_ADDRESS>of your intention to attend the meeting. The
agenda will include the following:

April 8

 Welcome (Committee chairs)
 Introductions, logistics
 Plenary Session:
     Review/Approval of the Twenty-Second Meeting Summary, RTCA
Paper No. 238-13/SC216-047.
     RTCA PMC Report
     FAA Status Report
     Coordination between drafting groups
 Subgroup Breakouts--if needed
     Review any remaining document comments

April 9

 Additional Subgroup Breakouts--if needed
     Review Any Remaining Document Comments
 Reconvene Plenary for Status
     Review Schedule
 Review/Approval--Revised DO-326--Airworthiness Security
Process Specification, RTCA Paper No. 239-13/SC216-048.
 Review/Approval--New Document, Information Security Guidance
for Continuing Airworthiness, RTCA Paper No. 240-13/SC216-049.
 Adjourn

    Note:  Subgroup 2 may continue to meet separately from this
meeting on April 10th in order to continue work on DO-yy3/ED-203.
Those interested in this document are encouraged to remain and
participate.

    Attendance is open to the interested public but limited to space
availability. With the approval of the chairman, members of the public
may present oral statements at the meeting. Persons wishing to present
statements or obtain information should contact the person listed in
the FOR FURTHER INFORMATION CONTACT section. Members of the public may
present a written statement to the committee at any time.

    Issued in Washington, DC, on March 18, 2014.
Paige Williams,
Management Analyst, NextGen, Business Operations Group, Federal
Aviation Administration.
[FR Doc. 2014-06359 Filed 3-21-14; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 81, Number 223 (Friday, November 18, 2016)]
[Notices]
[Page 81758]
[FR Doc No: 2016-27814]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER17-242-000]

Gavin Power, LLC; Supplemental Notice That Initial Market-Based
Rate Filing Includes Request for Blanket Section 204 Authorization

    This is a supplemental notice in the above-referenced proceeding
Gavin Power, LLC`s application for market-based rate authority, with an
accompanying rate tariff, noting that such application includes a
request for blanket authorization, under 18 CFR part 34, of future
issuances of securities and assumptions of liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street NE., Washington,
DC 20426, in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone
filing a motion to intervene or protest must serve a copy of that
document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is November 30, 2016.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
5 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First Street NE., Washington, DC 20426.
    The filings in the above-referenced proceeding are accessible in
the Commission's eLibrary system by clicking on the appropriate link in
the above list. They are also available for electronic 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>.

    Dated: November 10, 2016.
Kimberly D. Bose,
Secretary.
[FR Doc. 2016-27814 Filed 11-17-16; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register: November 26, 2008 (Volume 73, Number 229)]
[Notices]
[Page 72094-72097]
[DOCID:fr26no08-113]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-58979; File No. SR-NYSE-2008-116]

Self-Regulatory Organizations; New York Stock Exchange LLC;
Notice of Filing of Proposed Rule Change Amending Rule 411(b)
Concerning Certain Odd-Lot Order Handling Requirements, Rescinding NYSE
Information Memorandum 94-14 and Issuing a New Information Memo That
Provides Comprehensive and Updated Interpretive Guidance on, and
Application of, Current NYSE Odd-Lot Trading Practices and Rules

November 19, 2008.
    Pursuant to Section 19(b)(1) \1\ of the Securities Exchange Act of
1934 (``Act'') \2\ and Rule 19b-4 thereunder,\3\ notice is hereby given
that, on November 6, 2008, New York Stock Exchange LLC (``NYSE'' or
``Exchange'') filed with the Securities and Exchange Commission
(``Commission'' or ``SEC'') 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.
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    \1\ 15 U.S.C.78s(b)(1).
    \2\ 15 U.S.C. 78a.
    \3\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to (i) amend Rule 411(b) concerning certain
odd-lot order handling requirements, (ii) rescind NYSE Information
Memorandum (``Information Memo'') 94-14 to the extent it created a
distinction in the regulatory treatment of odd-lot limit and odd-lot
market orders, and (iii) issue a new Information Memo that provides
comprehensive and updated interpretive guidance on, and application of,
current NYSE odd-lot trading practices and Rules. This rule filing is
available on the Exchange's Web site at http://www.nyse.com, at the
Exchange's principal office, and at the Public Reference Room of the
Commission.

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

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

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

1. Purpose
    This proposal is to (i) amend NYSE Rule 411(b) concerning certain
odd-lot order handling requirements, (ii) rescind NYSE Information Memo
94-14 to the extent it created a distinction in the regulatory
treatment of odd-lot limit and odd-lot market orders, and (iii) issue a
new Information Memo that provides comprehensive and updated
interpretive guidance on, and application of, current NYSE odd-lot
trading practices and Rules.
Current Operation of the Odd-Lot Order System
    The odd-lot order system is used for all orders for less than a
unit of trading (a unit of trading is generally referred to as a
``round-lot''), currently set at 100 shares for most NYSE-listed
securities.\4\ These orders, which are too small to be handled
efficiently in the regular auction market on the Exchange,
traditionally, have been used by retail investors to buy and sell small
amounts of stock. More recently, market

professionals using certain trading strategies and programs have also
accessed the odd-lot system.
---------------------------------------------------------------------------

    \4\ The vast majority of securities trade in round-lots of 100
shares; however, there are some securities that trade in round-lots
of 10 or even 1 share.
---------------------------------------------------------------------------

    NYSE Rule 124 prescribes certain rules governing the execution of
odd-lot orders. Among other things, because odd-lot orders are executed
outside the regular auction market, Rule 124(a) prescribes that the
Designated Market Maker (``DMM'') is the contra party for all odd-lot
orders, thereby providing execution and price guarantees. Pursuant to
NYSE Rule 124(c), odd-lot market orders and marketable limit orders are
subject to automatic execution at the price of the next round-lot
transaction in the subject security on the Exchange.
    NYSE Rule 411(b) prescribes certain order-handling requirements for
odd-lot orders. In particular, Rule 411(b)(1) provides that member
organizations may not combine (or ``bunch'') multiple odd-lot orders
from different customers without prior approval. The Rule also requires
member organizations to aggregate odd-lot orders, where possible, into
as many round lot orders as possible rather than process them
separately. Although not expressly stated, Rule 411(b) also implicitly
prohibits a customer or member organization from unbundling a round-lot
order in order to avoid the round-lot market and take advantage of the
odd-lot market.
Background
    The odd-lot system was initially created to replace odd-lot dealers
on the Exchange. Before the creation of the odd-lot system, odd-lot
dealers made markets in odd-lots and either paired-off odd-lot orders
against each other or traded with them as dealers. When the Exchange
eliminated separate odd-lot dealers and adopted Rule 124, DMMs (at the
time, specialists) were made the counter-party for each odd-lot order
execution in their respective stocks.
    Because the system forces DMMs to provide liquidity, the Exchange
has always sought to limit the use of the odd-lot order system to only
the types of trading it replaced (so-called ``traditional'' or
``standard'' odd-lot trading practices) in order to ensure the system's
continued economic viability. In particular, the Exchange has long
prohibited the specific use of the odd-lot order system as a
professional trading platform, because it reduces the DMMs' willingness
to provide cost effective and efficient liquidity for the odd-lot
system as a whole. Accordingly, the Exchange has on many occasions
issued guidance that any use of the odd-lot system in a manner that is
inconsistent with traditional or standard odd-lot investment activity
is strictly prohibited.
Distinction in Regulatory Treatment of Odd-Lot Limit and Odd-Lot Market
Orders
    Information Memo 94-14 provides that certain trading practices that
rely specifically on odd-lot limit orders are flatly prohibited.\5\
Under the terms of Information Memo 94-14, however, odd-lot market
orders were not subject to the same restrictions.
---------------------------------------------------------------------------

    \5\ See Information Memo 94-14 (April 18, 1994). See also
Securities Exchange Act Release No. 34-33678 (February 24, 1994), 59
FR 10192 (March 3, 1994) (SR-NYSE-92-13).
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    This distinction in the regulatory treatment between odd-lot limit
and odd-lot market orders noted in Information Memo 94-14 evolved from
changes made to the odd-lot order system in and around 1991.\6\ Before
then, DMMs were permitted to charge a differential on (i) all odd-lot
limit orders executed through the automated system, and (ii) any odd-
lot order that required manual handling; all other odd-lot orders,
including market orders, were executed without a differential.\7\
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    \6\ In May 1992, because it made changes to existing NYSE Rule
124, the Exchange submitted to the Commission the interpretive
guidance that would later become Information Memo 94-14, which was
approved in February 1994 after several amendments. See Securities
Exchange Act Release No. 34-33678 (February 24, 1994), 59 FR 10192
(March 3, 1994) (SR-NYSE-92-13) (formally adopting Information Memo
94-14). Information Memo 94-14 was subsequently distributed to all
members and member organizations on April 18, 1994.
    \7\ See Securities Exchange Act Release No. 34-28837 (January 14
[sic], 1991), 56 FR 4660 (February 5, 1991) (SR-NYSE-91-03).
---------------------------------------------------------------------------

    In February 1991, at the conclusion of a six month pilot program,
the Exchange amended NYSE Rule 124 to eliminate price differentials on
odd-lot orders executed on the Exchange and extended the ``no
commission policy'' to cover floor brokerage charges on all
systematized odd-lot orders. The Exchange stated that, by providing
more economic pricing, the amendments would enhance the efficiency of
odd-lot order executions compatible with the traditional odd-lot
investing practices of smaller investors. Although there were concerns
about possible adverse impacts to the odd-lot market, the data
collected during the implementation of the pilot program reflected that
the mix of odd-lot limit and market orders had remained at or near
historical levels and there was no evidence of regulatory issues or
trading abuses.\8\
---------------------------------------------------------------------------

    \8\ See Securities Exchange Act Release No. 34-28837 (January 14
[sic], 1991), 56 FR 4660 (February 5, 1991) (SR-NYSE-91-03). See
also Securities Exchange Act Release No. 34-33678 (February 24,
1994), 59 FR 10192 (March 3, 1994) (SR-NYSE-92-13).
---------------------------------------------------------------------------

    In July 1991, after implementation of the amendments and further
observation of the odd-lot market, the Exchange released Information
Memo 91-29. In that Information Memo, the Exchange identified and
precluded certain trading practices that had developed that were
inconsistent with traditional or standard odd-lot trading practices and
that undermined the economic benefits derived by the market from the
elimination of differential pricing for odd-lot orders. These practices
included the unbundling of round-lot orders for the purpose of entering
odd-lot limit orders in comparable amounts, the failure to aggregate
into round-lots odd-lot orders from the same account or accounts with a
common monetary interest, and the entry of odd-lot limit orders on both
sides of the market for a security in order to capture the ``spread''.
The Exchange also emphasized more generally that any odd-lot order
entry practices intended to circumvent the round-lot auction market
were prohibited.\9\
---------------------------------------------------------------------------

    \9\ See Information Memo 91-29 (July 25, 1991).
---------------------------------------------------------------------------

    To address these issues in part, in 1992 the Exchange amended NYSE
Rule 411(b) to expand the requirement for aggregating odd-lot orders to
include market participants who entered multiple orders on behalf of
various accounts over which they had investment discretion.\10\
---------------------------------------------------------------------------

    \10\ See Securities Exchange Act Release No. 34-31048 (August
18, 1992), 57 FR 38706 (August 26, 1992) (SR-NYSE-92-03).
---------------------------------------------------------------------------

    In Information Memo 94-14, the Exchange identified and precluded
additional types of trading using odd-lot limit orders in particular,
including index arbitrage, program trading and day trading, as
inconsistent with traditional or standard odd-lot trading practices and
that undermined the integrity of the odd-lot order system and its
purpose. At that time, the Exchange noted that such trading practices
using odd-lot market orders were not precluded.\11\
---------------------------------------------------------------------------

    \11\ See Information Memo 94-14 (April 18, 1994). See also
Securities Exchange Act Release No. 34-33678 (February 24, 1994), 59
FR 10192 (March 3, 1994) (SR-NYSE-92-13).
---------------------------------------------------------------------------

    More recently, in Information Memo 07-60, the Exchange provided
additional interpretive guidance concerning the odd-lot system,
including an overview of various types of prohibited trading
practices.\12\
---------------------------------------------------------------------------

    \12\ See Information Memo 07-60 (June 29, 2007). This
Information Memo was not filed with the SEC.
---------------------------------------------------------------------------

Proposed Rule Changes
    The rules and interpretive guidance (in the form of Information
Memos and Enforcement Decisions) for the

Exchange's odd-lot order system have evolved over the years in response
to changes in the way market participants use the system. This has
resulted in a set of rules and policies that, while comprehensive, is
not readily accessible in one source. Moreover, some of the rules (i.e.
Rule 411(b)) have not been updated to reflect the Exchange's most
current interpretive guidance and application of odd-lot trading
practices. As a result, and as described more fully below, the Exchange
proposes the following changes in order to update Rule 411(b) and to
provide a single source of interpretive guidance in accordance with the
current odd-lot order system and trading practices.
2. Proposed Amendments to Rule 411(b)
    The Exchange proposes to amend Rule 411(b) to update and clarify
certain odd-lot trading practices described in the Rule.
    First, the Exchange proposes to amend the first subparagraph of the
Rule to clarify that a person, member or member organization shall not
enter or accept multiple odd-lot orders in the same security where
those orders can be aggregated into round-lots. Under the current Rule,
members or member organizations must monitor and aggregate odd-lot
orders received from their customers where appropriate. As amended, the
Rule would also explicitly provide that members or member organizations
must not submit un-aggregated orders.
    In addition, the Exchange proposes to limit the requirement to
aggregate odd-lot orders to regular trading hours from 9:30 a.m. to 4
p.m. The Exchange's member firms have differing systems and procedures
that make it difficult to standardize their capability to aggregate
odd-lot orders prior to the commencement of trading at 9:30 a.m. As a
result, the Exchange believes that it is more equitable to limit the
aggregation requirement to regular trading hours.
    The Exchange also proposes to add a new subparagraph to the Rule to
explicitly provide that no person, member or member organization shall
unbundle market or limit round-lot orders for the purpose of entering
multiple odd-lot orders that aggregate to an amount comparable to the
amount of the original round-lot order(s).\13\
---------------------------------------------------------------------------

    \13\ E-mail from Jason Harman, Consultant, NYSE Regulation, to
Nathan Saunders, Special Counsel, and Steve Varholik, Attorney,
Division of Trading and Markets, Commission, on November 18, 2008
(clarifying discussion relating to proposed NYSE Rule 411(b)(3)).
---------------------------------------------------------------------------

    Finally, the Exchange proposes to make technical amendments to Rule
411(b) to reorder and renumber the subparagraphs in this section in
accordance with these proposed amendments.
3.Proposed Rescission of Information Memo 94-14 and Issuance of New
Information Memo
    The Exchange is seeking approval from the SEC to rescind
Information Memo 94-14 and to eliminate the regulatory distinction
between odd-lot limit and odd-lot market orders.
    The distinction in the regulatory treatment of odd-lot limit and
odd-lot market orders as described in Information Memo 94-14 is no
longer necessary or practical in today's market. In the past, as
observed by the Exchange, odd-lot limit orders could be and were used
by market participants to access the odd-lot order system in ways that
were inconsistent with traditional or standard odd-lot trading and that
undermined the integrity of the odd-lot order system. Since the filing
and approval of Information Memo 94-14, however, the market has
undergone significant changes, including the adoption of Regulation NMS
and technological developments impacting order routing and execution.
Today, volume is much greater and the speed of the market has increased
such that most limit orders are effectively market orders when entered.
In addition, there are numerous programs and algorithmic trading
platforms that permit market participants to use trading strategies
involving both limit and market orders. At the same time, the Exchange
has better tools with which to conduct market surveillance and
regulation.
    In conjunction with these changes to the marketplace, NYSE
Regulation has noted the increasing use of odd-lot market orders in
trading practices that, were they implemented using odd-lot limit
orders (even marketable limit orders), would be violations of the
Exchange's current odd-lot rules and interpretive guidance. These
trading practices are designed to circumvent the auction market and
provide liquidity and pricing that is not otherwise available, or to
create an unfair advantage over other market participants, and, as a
result, threaten to undermine the economic viability of the odd-lot
trading system and reduce the DMMs' willingness to provide cost-
effective and efficient liquidity.
    Given this trend, the Exchange believes that it is no longer
proper, or consistent with the protection of investors, to maintain a
regulatory distinction between odd-lot limit and odd-lot market orders
in determining whether odd-lot activity is violative and that,
moreover, continuation of this distinction impedes the appropriate
regulation of abusive trading practices involving both odd-lot limit
and odd-lot market orders.
    In addition, in the interest of providing market participants with
a single, comprehensive source of guidance, the Exchange proposes to
issue a new Information Memo that would update and restate the
Exchange's most current interpretive guidance and application of odd-
lot trading practices and Rules. The proposed new Information Memo
would retain the relevant portions of Information Memo 94-14 and prior
Information Memos, as well as the more recent guidance issued in
Information Memo 07-60.
4. Statutory Basis
    The statutory basis for the proposed rule change is Section 6(b)(5)
of the Act,\14\ which requires the rules of an exchange to prevent
fraudulent and manipulative acts and practices, 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. The proposed
rule change also supports the principles of Section 11A(a)(1) \15\ of
the Act, in that it seeks to ensure economically efficient execution of
securities transactions and fair competition among brokers and dealers
and among exchange markets.
---------------------------------------------------------------------------

    \14\ 15 U.S.C. 78f(b)(5).
    \15\ 15 U.S.C. 78k-1(a)(1).
---------------------------------------------------------------------------

    In particular, as noted above, the proposed rule filing would bring
the Exchange's odd-lot Rules and interpretive guidance into line with
the way the odd-lot system is currently used by market participants.
The proposed filing also would eliminate a historical distinction in
the regulatory treatment of odd-lot trading that is no longer relevant
in today's market. The Exchange has observed patterns of abuse by
market participants who have crafted schemes involving odd-lot market
orders that, were they implemented using odd-lot limit orders, would be
violations of the Exchange's current odd-lot rules and interpretive
guidance. The Exchange believes that, in order to effectively regulate
the use of the odd-lot system and protect investors, it is necessary to
close this loophole. In addition, the proposed filing would provide
market participants with a comprehensive source of the Exchange's most
current interpretive guidance and

application of odd-lot trading practices and Rules.

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 that is 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 solicited or received with respect to the
proposed rule change.

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

    Within 35 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 self-regulatory organization consents, the Commission will:
    (A) By order approve the 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 (http://
www.sec.gov/rules/sro.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File Number SR-NYSE-2008-116 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NYSE-2008-116. 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 inspection and
copying 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-NYSE-2008-116 and should be
submitted on or before December 17, 2008.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\16\
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    \16\ 17 CFR 200.30-3(a)(12).
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Florence E. Harmon,
Acting Secretary.
[FR Doc. E8-28042 Filed 11-25-08; 8:45 am]

BILLING CODE 8011-01-P