[Federal Register Volume 80, Number 19 (Thursday, January 29, 2015)]
[Notices]
[Pages 4951-4953]
[FR Doc No: 2015-01647]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-74128; File No. SR-NYSE-2015-03]

Self-Regulatory Organizations; New York Stock Exchange LLC;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change
Establishing the NYSE Integrated Feed Data Feed

January 23, 2015.
    Pursuant to Section 19(b)(1) \1\ of the Securities Exchange Act of
1934 (the ``Act'') \2\ and Rule 19b-4 thereunder,\3\ notice is hereby
given that on January 21, 2015, New York Stock Exchange LLC (``NYSE''
or the ``Exchange'') filed with the Securities and Exchange Commission
(the ``Commission'') the proposed rule change as described in Items I
and II below, which Items have been prepared by the self-regulatory
organization. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
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    \1\ 15 U.S.C.78s(b)(1).
    \2\ 15 U.S.C. 78a.
    \3\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to establish the NYSE Integrated Feed (``NYSE
Integrated Feed'') data feed. The text of the proposed rule change is
available on the Exchange's Web site at www.nyse.com, at the principal
office of the Exchange, and at the Commission's Public Reference Room.

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

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

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

1. Purpose
    The Exchange proposes to establish the NYSE Integrated Feed. The
NYSE Integrated Feed would provide real-time market data in a unified
view of events, in sequence, as they appear on the NYSE matching
engines. The NYSE Integrated Feed would include depth of book order
data, last sale data, and opening and closing imbalance data. The NYSE
Integrated Feed would also include security status updates (e.g., trade
corrections and trading halts) and stock summary messages. The stock
summary message updates every minute and includes NYSE's opening price,
high price, low price, closing price, and cumulative volume for the
security. The NYSE Integrated Feed would include information currently
available from three existing NYSE real-time market data feeds: NYSE
OpenBook,\4\ which provides a compilation of all limit orders resident
in the NYSE limit order book; NYSE Trades,\5\ which provides NYSE last
sale information on a real-time basis; and NYSE Order Imbalances,\6\
which publishes order imbalance information prior to the opening and
closing of trading.\7\
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    \4\ See Securities Exchange Act Release Nos. 44962 (Oct. 15,
2001), 66 FR 554562 (Oct. 29, 2001) (SR-NYSE-2001-42); 54594 (Oct.
6, 2006), 71 FR 61819 (Oct. 19, 2006) (SR-NYSE-2006-81); 56384 (Aug.
30, 2007), 72 FR 53271 (SR-NYSE-2007-80).
    \5\ See Securities Exchange Act Release Nos. 59290 (Jan. 23,
2009), 74 FR 5707 (Jan. 30, 2009) (SR-NYSE-2009-05); 59606 (Mar. 19,
2009), 74 FR 13293 (Mar. 26, 2009) (SR-NYSE-2009-04).
    \6\ See Securities Exchange Act Release Nos. 59543 (March 9,
2009), 74 FR 11159 (March 16, 2009) (SR-NYSE-2008-132); 60153 (June
19, 2009), 74 FR 30656 (June 26, 2009) (SR-NYSE-2009-49).
    \7\ Neither this filing nor the later filing establishing fees
for the NYSE Integrated Feed will have any effect on the filings for
NYSE Openbook, NYSE Trades, or NYSE Order Imbalances.
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    The Exchange proposes to offer the NYSE Integrated Feed through the
Exchange's Liquidity Center Network (``LCN''), a local area network in
the Exchange's Mahwah, New Jersey data center that is available to
users of the Exchange's co-location services. The Exchange also would
offer the NYSE Integrated Feed through the Exchange's Secure Financial
Transaction Infrastructure (``SFTI'') network, through which all other
users and member organizations access the Exchange's trading and
execution systems and other proprietary market data products.
    Offering an integrated product addresses requests received from
vendors and subscribers that would like to receive the data described
above in an integrated fashion. An integrated data feed would provide
greater efficiencies and reduce errors for vendors and subscribers that
currently choose to integrate the data after receiving it from the
Exchange. The Exchange believes that providing vendors and subscribers
with the option of a market data product that both integrates existing
products and includes additional market data would allow vendors and
subscribers to choose the best solution for their specific businesses.
    The Exchange will file a separate rule filing to establish the fees
for the NYSE Integrated Feed and will announce the date that the NYSE
Integrated Feed will be available through an NYSE Market Data Notice.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with Section 6(b) \8\ of the Act, in general, and furthers the
objectives of Section 6(b)(5) \9\ of the Act, in particular, in that it
is designed to prevent fraudulent and manipulative acts and practices,
to promote just and equitable principles of trade, to foster
cooperation and coordination with persons engaged in facilitating
transactions in securities, to remove impediments to and perfect the
mechanism of a free and open market and a national market system and,
in general, to protect investors and the public interest, and it is not
designed to permit unfair discrimination among customers, brokers, or
dealers. This proposal is in keeping with those principles in that it
promotes increased transparency through the dissemination of the NYSE
Integrated Feed to those interested in receiving it.
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    \8\ 15 U.S.C. 78f(b).
    \9\ 15 U.S.C. 78f(b)(5).
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    The Exchange also believes this proposal is consistent with Section
6(b)(5) of the Act because it protects investors and the public
interest and promotes just and equitable principles of trade by
providing investors with new options for receiving market data as
requested by market data vendors and purchasers. The proposed rule
change would benefit investors by facilitating their prompt access to
the real-time information contained in the NYSE Integrated Feed.
    In adopting Regulation NMS, the Commission granted self-regulatory
organizations (``SROs'') and broker dealers increased authority and
flexibility to offer new and unique market data to consumers of such
data. It was believed that this authority would expand the amount of
data available to users and consumers of such data and also spur
innovation and competition for the provision of market data. The
Exchange believes that the NYSE Integrated Feed is precisely the sort
of market data product that the Commission envisioned when it adopted
Regulation NMS. The Commission concluded that Regulation NMS would
itself further the Act's goals of facilitating efficiency and
competition:

    Efficiency is promoted when broker-dealers who do not need the
data beyond the prices, sizes, market center identifications of the
NBBO and consolidated last sale information are not required to
receive (and pay for) such data. The Commission also believes that
efficiency is promoted when broker-dealers may choose to receive
(and pay for) additional market data based on their own internal
analysis of the need for such data.\10\
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    \10\ See Securities Exchange Act Release No. 51808 (June 9,
2005), 70 FR 37496 (June 29, 2005) (``Regulation NMS Adopting
Release'').

    The Exchange further notes that the existence of alternatives to
the Exchange's product, including real-time consolidated data, free
delayed consolidated data, and proprietary data from other sources, as
well as the continued availability of the Exchange's separate data
feeds, ensures that the Exchange is not unreasonably discriminatory
because vendors and subscribers can elect these alternatives as their
individual business cases warrant.
    The NYSE Integrated Feed will help to protect a free and open
market by providing additional data to the marketplace and by giving
investors greater choices. In addition, the proposal would not permit
unfair discrimination because the product will be available to all of
the Exchange's customers and broker-dealers through both the LCN and
SFTI.

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

    In accordance with Section 6(b)(8) of the Act,\11\ 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. Because other exchanges already offer similar
products, the Exchange's proposed NYSE Integrated Feed will enhance
competition. The NYSE Integrated Feed will foster competition by
providing an alternative to similar products offered by other
exchanges, including the NYSE Arca Integrated

Feed,\12\ offered by the Exchange's affiliate, NYSE Arca, Inc. (``NYSE
Arca''), Nasdaq TotalView-Itch,\13\ offered by The Nasdaq Stock Market,
Inc., and BATS Multicast Pitch,\14\ offered by BATS Global Markets.
This proposed new data feed provides investors with new options for
receiving market data, which was a primary goal of the market data
amendments adopted by Regulation NMS.\15\
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    \11\ 15 U.S.C. 78f(b)(8).
    \12\ See NYSE Arca Integrated Feed, http://www.nyxdata.com/page/1084 (last visited January 5, 2015)(data feed that provides a
unified view of events, in sequence as they appear on the NYSE Arca
matching engine, including depth of book, trades, order imbalance
data, and security status messages).
    \13\ See Nasdaq TotalView-ITCH, http://www.nasdaqtrader.com/Trader.aspx?id=Totalview2 (last visited January 5, 2015)(displays
the full order book depth for Nasdaq market participants and also
disseminates the Net Order Imbalance Indicator (NOII) for the Nasdaq
Opening and Closing Crosses and Nasdaq IPO/Halt Cross).
    \14\ See BATS Multicast PITCH, http://www.batstrading.com/market_data/products/ (last visited January 5, 2015)(real-time depth
of book quotations and execution information).
    \15\ See Regulation NMS Adopting Release, supra, at 37503.
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C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

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

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

    The Exchange has filed the proposed rule change pursuant to Section
19(b)(3)(A)(iii) of the Act \16\ and Rule 19b-4(f)(6) thereunder.\17\
Because the proposed rule change does not: (i) Significantly affect the
protection of investors or the public interest; (ii) impose any
significant burden on competition; and (iii) become operative prior to
30 days from the date on which it was filed, or such shorter time as
the Commission may designate, if consistent with the protection of
investors and the public interest, provided that the self-regulatory
organization has given the Commission written notice of its intent to
file the proposed rule change at least five business days prior to the
date of filing of the proposed rule change or such shorter time as
designated by the Commission,\18\ the proposed rule change has become
effective pursuant to Section 19(b)(3)(A) of the Act and Rule 19b-
4(f)(6)(iii) thereunder.
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    \16\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \17\ 17 CFR 240.19b-4(f)(6).
    \18\ The Exchange has satisfied this requirement.
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    At any time within 60 days of the filing of such proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission shall institute proceedings under
Section 19(b)(2)(B) \19\ of the Act to determine whether the proposed
rule change should be approved or disapproved.
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    \19\ 15 U.S.C. 78s(b)(2)(B).
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IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-NYSE-2015-03 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-NYSE-2015-03. 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 Section, 100 F Street
NE., Washington, DC 20549-1090, on official business days between the
hours of 10:00 a.m. and 3:00 p.m. Copies of the filing will also be
available for Web site viewing and printing at the NYSE's principal
office and on its Internet Web site at www.nyse.com. 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-2015-03 and should be
submitted on or before February 19, 2015.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\20\
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    \20\ 17 CFR 200.30-3(a)(12).
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Brent J. Fields,
Secretary.
[FR Doc. 2015-01647 Filed 1-28-15; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 79, Number 103 (Thursday, May 29, 2014)]
[Notices]
[Pages 30855-30856]
[FR Doc No: 2014-12349]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-E-0035]

Determination of Regulatory Review Period for Purposes of Patent
Extension; XARELTO

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for XARELTO and is publishing this notice of
that determination as required by law. FDA has made the determination
because of the submission of an application to the Director of Patents
and Trademarks, Department of Commerce, for the extension of a patent
which claims that human drug product.

ADDRESSES: Submit electronic comments to http://www.regulations.gov.
Submit written petitions (two copies are required) and written comments
to the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
Submit petitions electronically to http://www.regulations.gov at Docket
No. FDA-2013-S-0610.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of
Management, Center for Drug Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6257, Silver
Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term
Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug
and Patent Term Restoration Act (Pub. L. 100-670) generally provide
that a patent may be extended for a period of up to 5 years so long as
the patented item (human drug product, animal drug product, medical
device, food additive, or color additive) was subject to regulatory
review by FDA before the item was marketed. Under these acts, a
product's regulatory review period forms the basis for determining the
amount of extension an applicant may receive.
    A regulatory review period consists of two periods of time: A
testing phase and an approval phase. For human drug products, the
testing phase begins when the exemption to permit the clinical
investigations of the drug becomes effective and runs until the
approval phase begins. The approval phase starts with the initial
submission of an application to market the human drug product and
continues until FDA grants permission to market the drug product.
Although only a portion of a regulatory review period may count toward
the actual amount of extension that the Director of Patents and
Trademarks may award (for example, half the testing phase must be
subtracted as well as any time that may have occurred before the patent
was issued), FDA's determination of the length of a regulatory review
period for a human drug product will include all of the testing phase
and approval phase as specified in 35 U.S.C. 156(g)(1)(B).
    FDA has approved for marketing the human drug product XARELTO
(rivaroxaban). XARELTO is indicated for the prophylaxis of deep vein
thrombosis, which may lead to pulmonary embolism in patients undergoing
knee or hip replacement surgery. Subsequent to this approval, the
Patent and Trademark Office received a patent term restoration
application for XARELTO (U.S. Patent No. 7,157,456) from Bayer Pharma
Aktiengesellschaft, and the Patent and Trademark Office requested FDA's
assistance in determining this patent's eligibility for patent term
restoration. In a letter dated July 9, 2012, FDA advised the Patent and
Trademark Office that this human drug product had undergone a
regulatory review period and that the approval of XARELTO represented
the first permitted commercial marketing or use of the product.
Thereafter, the Patent and Trademark Office requested that FDA
determine the product's regulatory review period.
    FDA has determined that the applicable regulatory review period for
XARELTO is 3,291 days. Of this time, 2,222 days occurred during the
testing phase of the regulatory review period, while 1,069 days
occurred during the approval phase. These periods of time were derived
from the following dates:
    1. The date an exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 355(i)) became
effective: June 29, 2002. The applicant claims June 30, 2002, as the
date the investigational new drug application (IND) became effective.
However, FDA records indicate that the IND effective date was June 29,
2002, which was 30 days after FDA receipt of the IND.
    2. The date the application was initially submitted with respect to
the human drug product under section 505(b) of the FD&C Act: July 28,
2008. FDA has verified the applicant's claim that the new drug
application (NDA) for XARELTO (NDA 22-406) was submitted on July 28,
2008.
    3. The date the application was approved: July 1, 2011. FDA has
verified the applicant's claim that NDA 22-406 was approved on July 1,
2011.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the Patent and
Trademark Office applies several statutory limitations in its
calculations of the actual period for patent extension. In its
application for patent extension, this applicant seeks 1,354 days of
patent term extension.
    Anyone with knowledge that any of the dates as published are
incorrect may submit to the Division of Dockets Management (see
ADDRESSES) either electronic or written comments and ask for a
redetermination by July 28, 2014. Furthermore, any interested person
may petition FDA for a determination regarding whether the applicant
for extension acted with due diligence during the regulatory review
period by November 25, 2014. To meet its burden, the petition must
contain sufficient facts to merit an FDA investigation. (See H. Rept.
857, part 1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should
be in the format specified in 21 CFR 10.30.
    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) electronic or written comments and written or
electronic petitions. 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. If you submit a written petition, two copies are required. A
petition submitted electronically must be submitted to http://www.regulations.gov, Docket No. FDA-2013-S-0610. Comments and petitions
that have not been made publicly available on http://www.regulations.gov may be viewed in the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: May 21, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-12349 Filed 5-28-14; 8:45 am]
BILLING CODE 4160-01-P


UNITED STATES ENVIRONMENTAL PROTECTION AGENCY                NATIONAL VEHICLE AND FUEL EMISSIONS LABORATORY
                              2565 PLYMOUTH ROAD
                        ANN ARBOR, MICHIGAN 48105-2498

                                   OFFICE OF
                               AIR AND RADIATION

MEMORANDUM

SUBJECT:	Heavy-Duty Hybrid Onboard Diagnostics

FROM:		Amy Kopin

TO:		The Docket

DATE:		July 15, 2011

	On July 6th, 2011 we held a conference call with the California Air Resources Board (CARB) to discuss concerns raised by hybrid manufacturers, engine manufacturers, and related industry trade groups regarding heavy-duty onboard diagnostic (OBD) requirements and timing. Concerns were raised during the comment period for the heavy-duty greenhouse gas notice of proposed rulemaking that heavy-duty hybrid applications may not be able to meet the 2013 heavy-duty OBD regulations that were published in the 2009 OBD Final Rulemaking.[,]  Specifically, manufacturers have requested a delay of the application of HD OBD requirements for hybrid applications until 2020.  Attendees from the EPA and CARB are shown in the table below.

 Attendee
Affiliation
Cleophas Jackson
EPA  -  Compliance and Innovative Strategies Division
Anthony Neam
EPA  -  Assessment and Standards Division
Amy Kopin
EPA  -  Assessment and Standards Division
Lucina Negrete
CARB
Jessica Dean
CARB
Michael McCarthy
CARB
Michael Regenfuss
CARB