[Federal Register: May 5, 2010 (Volume 75, Number 86)]
[Notices]
[Page 24710-24711]
[DOCID:fr05my10-100]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-P-0284]

Determination That BREVIBLOC (Esmolol Hydrochloride) Injection,
250 Milligrams/Milliliter, 10-Milliliter Ampule, Was Withdrawn From
Sale for Reasons of Safety or Effectiveness

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) has determined that
BREVIBLOC (esmolol hydrochloride (HCl)) Injection, 250 milligrams (mg)/
milliliter (mL), 10-mL ampule, was withdrawn from sale for reasons of
safety or effectiveness. This determination means the agency will not
accept or approve abbreviated new drug applications (ANDAs) for esmolol
HCl injection, 250 mg/mL, 10-mL ampule.

FOR FURTHER INFORMATION CONTACT: Olivia A. Pritzlaff, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6308, Silver Spring, MD 20993-0002, 301-
796-3601.

SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price
Competition and Patent Term Restoration Act of 1984 (Public Law 98-417)
(the 1984 amendments), which authorized the approval of duplicate
versions of drug products approved under an ANDA procedure. ANDA
applicants must, with certain exceptions, show that the drug for which
they are seeking approval contains the same active ingredient in the
same strength and dosage form as the ``listed drug,'' which is a
version of the drug that was previously approved under a new drug
application (NDA). ANDA applicants do not have to repeat the extensive
clinical testing otherwise necessary to gain approval of an NDA. The
only clinical data required in an ANDA are data to show that the drug
that is the subject of the ANDA is bioequivalent to the listed drug.
    The 1984 amendments include what is now section 505(j)(7) of the
Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355(j)(7)),
which requires FDA to publish a list of all approved drugs. FDA
publishes this list as part of the ``Approved Drug Products With
Therapeutic Equivalence Evaluations,'' which is generally known as the
``Orange Book.'' Under FDA regulations, drugs are removed from the list
if the agency withdraws or suspends approval of the drug's NDA or ANDA
for reasons of safety or effectiveness, or if FDA determines that the
listed drug was withdrawn from sale for reasons of safety or
effectiveness (section 505(j)(7)(C) of the act; 21 CFR 314.162).
    FDA will not approve an ANDA if the listed drug has been withdrawn
from sale for safety or effectiveness reasons (section 505(j)(4)(I) of
the act). Under Sec.  314.161(a)(1) (21 CFR 314.161(a)(1)), the agency
must determine whether a listed drug was withdrawn from sale for
reasons of safety or effectiveness before an ANDA that refers to that
listed drug may be approved. A drug that has been withdrawn from the
market for safety or effectiveness reasons is not a listed drug (21 CFR
314.3(b)). FDA may not approve an ANDA that does not refer to a listed
drug.
    BREVIBLOC (esmolol HCl)) Injection is the subject of NDA 19-386,
held by Baxter Healthcare Corp. (Baxter). BREVIBLOC is a
beta1-selective adrenergic receptor-blocking agent with a
short duration of action. BREVIBLOC is approved for the treatment of
supraventricular tachycardia. BREVIBLOC is also indicated for treatment
of intraoperative and postoperative tachycardia and/or hypertension.
    Baxter currently markets 4 product presentations of BREVIBLOC
Injection--10-mg/mL and 20-mg/mL ready-to-use vials and 10-mg/mL and
20-mg/mL premixed injection bags. Baxter has discontinued marketing the
following two product presentations of BREVIBLOC (esmolol HCl)
Injection:
     In 2003, Baxter discontinued BREVIBLOC (esmolol HCl)
Injection, 10 mg/mL (formulation without sodium chloride), and FDA
determined that this presentation of BREVIBLOC Injection was not
withdrawn from sale for reasons of safety or effectiveness (69 FR
47155, August 4, 2004).
     In 2007, Baxter discontinued BREVIBLOC (esmolol HCl)
Injection, 250 mg/mL, 10-mL ampule. In a letter dated June 28, 2007,
Baxter informed the agency that the company had decided to cease
manufacture and distribution of BREVIBLOC (esmolol HCl) Injection, 250
mg/mL, 10-mL ampule, because the product demonstrated a higher risk of
medication errors that may potentially result in serious outcomes.
Baxter observed that serious adverse events were associated with the
following medication errors:
     Mixups between the ready-to-use 10-mg/mL vial and the 250-
mg/mL, 10-mL ampule concentrate;
     Use of undiluted 250-mg/mL, 10-mL ampule concentrate;
     Dilution calculation errors with the 250-mg/mL, 10-mL
ampule concentrate; and
     Administration of the wrong drug.
    In a Dear Healthcare Professional letter dated August 20, 2007,
Baxter stated that their decision to cease manufacture of BREVIBLOC
(esmolol HCl) Injection, 250 mg/mL, 10-mL ampule, was made after
thorough review of adverse event reports, clinical usage studies, input
from clinicians, and initiatives to reduce medication errors.
    In a citizen petition dated March 27, 2008 (Docket No. FDA-2008-P-
0284), submitted under 21 CFR 10.30 and in accordance with 21 CFR
314.122 and 314.161, Bedford Laboratories (Bedford) requested that the
agency determine

whether BREVIBLOC (esmolol HCl) Injection, 250 mg/mL, 10-mL ampule, was
withdrawn from sale for reasons of safety or effectiveness. Bedford
noted that Baxter has publicly stated that the product was discontinued
due to safety issues surrounding medication errors and asked the agency
to determine the cause of the discontinuation.
    We have carefully reviewed our files for records concerning the
withdrawal from sale of BREVIBLOC (esmolol HCl) Injection, 250 mg/mL,
10-mL ampule, including the NDA file for this drug product. We have
also independently evaluated relevant literature and data for possible
postmarketing adverse event reports. FDA's review shows that the
product was withdrawn from sale because of reports of serious adverse
events, including deaths.
    Although the application holder has made several labeling revisions
(including a warning sticker on the ampule) and issued Dear Healthcare
Provider letters to reduce the potential for medication errors, there
have been additional reports of medication errors. In addition,
alternative presentations of the product are available that are not
associated with the same potential for medication errors.
    After considering the citizen petition (and comments submitted) and
reviewing agency records concerning the drug product, analyses of
adverse event reports, and relevant literature, FDA has determined
under Sec.  314.161 that BREVIBLOC (esmolol HCl) Injection, 250 mg/mL,
10-mL ampule, was withdrawn from sale for reasons of safety or
effectiveness. FDA has reviewed the latest approved labeling for
BREVIBLOC (esmolol HCl) Injection, 250 mg/mL, 10-mL ampule, and has
determined that this labeling is inadequate to reduce medication errors
to an acceptable level. FDA has determined that Human Factors studies
(i.e., Failure Mode and Effects Analysis and usability studies to test
the product in a typical practice setting) are necessary before this
product could be considered for reintroduction to the market.
    Therefore, the agency has determined, under Sec.  314.161, that
BREVIBLOC (esmolol HCl) Injection, 250 mg/mL, 10-mL ampule, was
withdrawn from sale for reasons of safety. BREVIBLOC (esmolol HCl)
Injection, 250 mg/mL, 10-mL ampule, will be removed from the list of
drug products published in the Orange Book. FDA will not accept or
approve ANDAs that refer to BREVIBLOC (esmolol HCl) Injection, 250 mg/
mL, 10-mL ampule.

    Dated: April 30, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-10559 Filed 5-4-10; 8:45 am]
BILLING CODE 4160-01-S


[Federal Register Volume 78, Number 189 (Monday, September 30, 2013)]
[Proposed Rules]
[Pages 59906-59907]
[FR Doc No: 2013-23798]

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DEPARTMENT OF TRANSPORTATION

Pipeline and Hazardous Materials Safety Administration

49 CFR Part 192

[Docket No. PHMSA-2013-0161]

Pipeline Safety: Class Location Requirements

AGENCY: Pipeline and Hazardous Materials Safety Administration, DOT.

ACTION: Notice of inquiry, extension of comment period.

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SUMMARY: On August 1, 2013, PHMSA published a notice of inquiry in the
Federal Register on ``Class Location Requirements,'' seeking comments
on whether integrity management program (IMP) requirements, or elements
of IMP, should be expanded beyond high consequence areas (HCA) and,
with respect to gas transmission pipeline facilities, whether applying
IMP requirements to additional areas would mitigate the need for class
location requirements. PHMSA has received two requests to extend the
comment period to allow stakeholders more time to evaluate the notice
of inquiry. PHMSA concurs with this request and is extending the
comment period from September 30, 2013, to November 1, 2013.

DATES: The comment period for the proposed rule published on August 1,
2013 (78 FR 46560), is extended. The closing date for filing comments
is extended from September 30, 2013, to November 1, 2013.

ADDRESSES: Comments should reference Docket No. PHMSA-2013-0161.
Comments may be submitted in the following ways:
     E-Gov Web site: http://www.regulations.gov. This site
allows the public to enter comments on any Federal Register notice
issued by any agency. Follow the instructions for submitting comments.
     Fax: 1-202-493-2251.
     Mail: Docket Management System, U.S. Department of
Transportation (DOT), 1200 New Jersey Avenue SE., Room W12-140,
Washington, DC 20590.
    Hand Delivery: DOT Docket Management System, Room W12-140, on the
ground floor of the West Building, 1200 New Jersey Avenue SE.,
Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays.
    Instructions: Identify the docket number at the beginning of your
comments. If you submit your comments by mail, submit two copies. If
you wish to receive confirmation that PHMSA has received your comments,
include a self-addressed stamped postcard. Internet users may submit
comments at http://www.regulations.gov.

    Note:  Comments will be posted without changes or edits to
http://www.regulations.gov, including any personal information
provided. Please see the Privacy Act Statement heading below for
additional information.

    Privacy Act statement: Anyone may search the electronic form of all
comments received for any of our dockets. You may review DOT's complete
Privacy Act Statement in the Federal Register published April 11, 2000
(65 FR 19477).

FOR FURTHER INFORMATION CONTACT: Mike Israni at<PHONE_NUMBER> or by
email at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: On August 1, 2013, PHMSA issued a notice of
inquiry (78 FR 46560), seeking public comment on whether applying the
IMP requirements, or elements of IMP, to areas beyond current HCAs
would mitigate the need for class location

requirements for gas transmission pipelines. It should be noted that
the notice dated August 1, 2013, was incorrectly identified as a
``Notice of proposed rulemaking'' instead of the correct identifier,
``Notice of inquiry.''
    The notice of inquiry was published in response to Section 5 of the
Pipeline Safety, Regulatory Certainty, and Job Creation Act of 2011,
which requires the Secretary of Transportation to evaluate and issue a
report on whether IMP requirements should be expanded beyond HCAs and
whether such expansion would mitigate the need for class location
requirements.
    The American Petroleum Institute (API) and American Gas Association
(AGA), on September 23, 2013, and September 24, 2013, respectively,
requested that PHMSA extend the notice comment period deadline from
September 30, 2013, to November 1, 2013, to give API and AGA members
enough time to share the notice with their membership and to collect
their members' responses and comments for docket submission.
    PHMSA concurs with API and AGA's request and is extending the
comment period from September 30, 2013, to November 1, 2013. This
extension will provide sufficient additional time for commenters to
submit their comments.

    Issued in Washington, DC, on September 25, 2013.
Alan K. Mayberry,
Deputy Associate Administrator for Policy and Programs.
[FR Doc. 2013-23798 Filed 9-27-13; 8:45 am]
BILLING CODE 4910-60-P


[Federal Register: August 6, 2010 (Volume 75, Number 151)]
[Notices]
[Page 47652-47655]
[DOCID:fr06au10-141]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-62623; File No. SR-NYSEArca-2010-51]

Self-Regulatory Organizations; NYSE Arca, Inc.; Order Granting
Approval of a Proposed Rule Change Relating to Listing and Trading of
WisdomTree Dreyfus Commodity Currency Fund under NYSE Arca Equities
Rule 8.600

August 2, 2010.

I. Introduction

    On June 10, 2010, NYSE Arca, Inc. (``Exchange'' or ``NYSE Arca''),
filed with the Securities and Exchange Commission (``Commission''),
pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ a proposed rule change to
list and trade the shares (``Shares'') of the WisdomTree Dreyfus
Commodity Currency Fund (``Fund'') under NYSE Arca Equities Rule 8.600.
The proposed rule change was published for comment in the Federal
Register on June 29, 2010.\3\ The Commission received no comment
letters on the proposal. This order approves the proposed rule change.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ Securities Exchange Act Release No. 62349 (June 22, 2010),
75 FR 37510 (``Notice'').
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II. Description of the Proposal

    The Exchange proposes to list and trade the Shares pursuant to NYSE
Arca Equities Rule 8.600 which governs the listing and trading of
``Managed Fund Shares'' on the Exchange.\4\
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    \4\ Managed Fund Shares are defined as securities that (a)
represent an interest in a registered investment company organized
as an open-end management investment company or similar entity that
invests in a portfolio of securities selected by the investment
company's investment adviser consistent with the investment
company's investment objectives and policies; (b) are issued in a
specified aggregate minimum number in return for a deposit of a
specified portfolio of securities and/or a cash amount with a value
equal to the next determined net asset value; and (c) when
aggregated in the same specified minimum number, may be redeemed at
a holder's request, which holder will be paid a specified portfolio
of securities and/or cash with a value equal to the next determined
net asset value. See NYSE Arca Equities Rule 8.600(c)(1).
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    The Fund will be an actively managed exchange traded fund. The
Shares will

be offered by the WisdomTree Trust (``Trust''), which was established
as a Delaware statutory trust on December 15, 2005. The Trust is
registered with the Commission as an investment company.\5\ WisdomTree
Asset Management, Inc. (``WisdomTree Asset Management'') is the
investment adviser (``Adviser'') to the Fund.\6\ The Exchange
represents that WisdomTree Asset Management is not affiliated with any
broker-dealer. The Dreyfus Corporation (``Dreyfus''), which will serve
as the sub-adviser for the Fund (``Sub-Adviser''), is affiliated with
multiple broker-dealers and, accordingly, has implemented a ``fire
wall'' with respect to such broker-dealers regarding access to
information concerning the composition and/or changes to the Fund's
portfolio.\7\ The Bank of New York is the administrator, custodian and
transfer agent for the Trust. ALPS Distributors, Inc. serves as the
distributor for the Trust.\8\
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    \5\ See Post-Effective Amendment No. 32 to Registration
Statement on Form N-1A for the Trust, dated March 19, 2010 (File
Nos. 333-132380 and 811-21864), as supplemented on June 8, 2010 (the
``Registration Statement''). The descriptions of the Fund and the
Shares contained herein are based on information in the Registration
Statement.
    \6\ WisdomTree Investments, Inc. (``WisdomTree Investments'') is
the parent company of WisdomTree Asset Management.
    \7\ The Exchange represents that the Adviser and Sub-Adviser,
and their related personnel, are subject to Investment Advisers Act
Rule 204A-1. This Rule specifically requires the adoption of a code
of ethics by an investment adviser to include, at a minimum: (i)
Standards of business conduct that reflect the firm's/personnel
fiduciary obligations; (ii) provisions requiring supervised persons
to comply with applicable Federal securities laws; (iii) provisions
that require all access persons to report, and the firm to review,
their personal securities transactions and holdings periodically as
specifically set forth in Rule 204A-1; (iv) provisions requiring
supervised persons to report any violations of the code of ethics
promptly to the chief compliance officer (``CCO'') or, provided the
CCO also receives reports of all violations, to other persons
designated in the code of ethics; and (v) provisions requiring the
investment adviser to provide each of the supervised persons with a
copy of the code of ethics with an acknowledgement by said
supervised persons. In addition, Rule 206(4)-7 under the Advisers
Act makes it unlawful for an investment adviser to provide
investment advice to clients unless such investment adviser has (i)
adopted and implemented written policies and procedures reasonably
designed to prevent violation, by the investment adviser and its
supervised persons, of the Advisers Act and the Commission rules
adopted thereunder; (ii) implemented, at a minimum, an annual review
regarding the adequacy of the policies and procedures established
pursuant to subparagraph (i) above and the effectiveness of their
implementation; and (iii) designated an individual (who is a
supervised person) responsible for administering the policies and
procedures adopted under subparagraph (i) above.
    \8\ The Commission has issued an order granting certain
exemptive relief to the Trust under the Investment Company Act of
1940 (15 U.S.C. 80a-1) (``1940 Act''). See Investment Company Act
Release No. 28174 (February 27, 2008) (File No. 812-13470). In
compliance with Commentary .05 to NYSE Arca Equities Rule 8.600,
which applies to Managed Fund Shares based on an international or
global portfolio, the Trust's application for exemptive relief under
the 1940 Act states that the Fund will comply with the Federal
securities laws in accepting securities for deposits and satisfying
redemptions with redemption securities, including that the
securities accepted for deposits and the securities used to satisfy
redemption requests are sold in transactions that would be exempt
from registration under the Securities Act of 1933 (15 U.S.C. 77a).
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WisdomTree Commodity Currency Fund

    The Fund seeks to achieve total returns reflective of money market
rates in selected commodity-producing countries and changes to the
value of such countries' currencies relative to the U.S. dollar.
    The Fund is designed to provide exposure to both the currencies and
money market rates available to foreign investors in selected
commodity-producing countries. The Fund intends to invest in commodity-
producing countries such as Australia, Brazil, Canada, Chile,
Indonesia, Mexico, New Zealand, Norway, Russia and South Africa. In
addition to seeking broad exposure across countries and currencies, the
Fund intends to seek exposure across currencies correlated to each of
the key commodity groups: Industrial metals, precious metals, energy,
agriculture and livestock. The Fund generally will invest only in
currencies that ``float'' relative to other currencies. The value of a
floating currency is largely determined by supply and demand and
prevailing market rates. In contrast, the value of a ``fixed'' currency
generally is set by a government or central bank at an official
exchange rate. The Fund generally does not intend to invest in the
currencies of notable commodity producers, such as China, Saudi Arabia
and the United Arab Emirates, since they are fixed or otherwise closely
linked to the U.S. dollar. The Fund will only invest in currencies that
it deems to be sufficiently liquid and accessible.\9\
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    \9\ The Fund may pursue its objectives through direct
investments in money market instruments issued by entities in the
applicable foreign country and denominated in the applicable non-
U.S. currency when WisdomTree Asset Management believes it is in the
best interest of the Fund to do so. The decision to secure exposure
directly or indirectly will be a function of, among other things,
market accessibility, credit exposure, and tax ramifications for
foreign investors. If the Fund pursues direct investment, eligible
investments include short-term securities issued by the applicable
foreign government and its agencies or instrumentalities, bank debt
obligations and time deposits, bankers' acceptances, commercial
paper, and short-term, high-quality corporate debt obligations
designed to provide exposure to the applicable non-U.S. currency and
money market rates, and U.S. dollar money market instruments.
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    The Fund intends to achieve exposure to selected commodity-
producing countries available to U.S. investors by investing primarily
in short-term U.S. money market securities and forward currency
contracts and swaps. The combination of money market securities with
forward currency contracts and currency swaps is designed to create a
position economically similar to a money market instrument denominated
in a non-U.S. currency. A forward currency contract is an agreement to
buy or sell a specific currency at a future date at a price set at the
time of the contract. A currency swap is an agreement between two
parties to exchange one currency for another at a future rate.
    In order to reduce interest rate risk, the Fund generally expects
to maintain an average portfolio maturity of 90 days or less. The
``average portfolio maturity'' of the Fund is the average of all the
current maturities of the individual securities in the Fund's
portfolio. All money market securities acquired by the Fund will be
rated in the upper two short-term ratings by at least two nationally
recognized statistical rating organizations (``NRSROs'') or, if
unrated, deemed by the Adviser to be of equivalent quality.
    As a matter of general policy, the Fund will invest, under normal
circumstances, at least 80% of its net assets, plus the amount of any
borrowings for investment purposes, in investments that are tied
economically to selected commodity-producing countries available to
U.S. investors that make a significant contribution to the global
export of commodities. If, subsequent to an investment, the 80%
requirement is no longer met, the Fund's future investments will be
made in a manner that will bring the Fund into compliance with this
policy.
    The Fund may invest up to an aggregate amount of 10% of its net
assets in illiquid securities. Illiquid securities include securities
subject to contractual or other restrictions on resale and other
instruments that lack readily available markets.
    Additional information regarding the Trust, the Fund, the Shares,
the investment objectives, strategies, policies, and restrictions,
risks, fees and expenses, creation and redemption procedures, portfolio
holdings, distributions and taxes, availability of information, trading
rules and halts, and surveillance procedures, among other things, can
be found in the Registration Statement and in the Notice, as
applicable.\10\
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    \10\ See supra notes 3 and 5.

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III. Discussion and Commission Findings

    After careful review, the Commission finds that the proposed rule
change is consistent with the requirements of Section 6 of the Act \11\
and the rules and regulations thereunder applicable to a national
securities exchange.\12\ In particular, the Commission finds that the
proposed rule change is consistent with the requirements of Section
6(b)(5) of the Act,\13\ which requires, among other things, that the
Exchange's rules be designed to prevent fraudulent and manipulative
acts and practices, 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.
The Commission notes that the Shares must comply with the requirements
of NYSE Arca Equities Rule 8.600 to be listed and traded on the
Exchange.
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    \11\ 15 U.S.C. 78f.
    \12\ In approving this proposed rule change, the Commission has
considered the proposed rule's impact on efficiency, competition,
and capital formation. See 15 U.S.C. 78c(f).
    \13\ 15 U.S.C. 78f(b)(5).
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    The Commission finds that the proposal to list and trade the Shares
on the Exchange is consistent with Section 11A(a)(1)(C)(iii) of the
Act,\14\ which sets forth Congress' finding that it is in the public
interest and appropriate for the protection of investors and the
maintenance of fair and orderly markets to assure the availability to
brokers, dealers, and investors of information with respect to
quotations for and transactions in securities. Quotation and last-sale
information for the Shares will be available via the Consolidated Tape
Association's high-speed line, and the Portfolio Indicative Value
(``PIV'') will be updated and disseminated by one or more major market
data vendors at least every 15 seconds during the Core Trading Session.
In addition, the Trust will make available on its Web site on each
business day before the commencement of trading in Shares in the Core
Trading Session the Disclosed Portfolio that will form the basis for
the calculation of the NAV, which will be determined at the end of the
business day.\15\ The Fund's Web site will also include additional
quantitative information updated on a daily basis relating to NAV.
Information regarding the market price and trading volume of the Shares
will be continually available on a real-time basis throughout the day
on brokers' computer screens and other electronic services, and the
previous day's closing price and trading volume information will be
published daily in the financial section of newspapers.
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    \14\ 15 U.S.C. 78k-1(a)(1)(C)(iii).
    \15\ The Commission notes that the Reporting Authority providing
the Disclosed Portfolio must implement and maintain, or be subject
to, procedures designed to prevent the use and dissemination of
material non-public information regarding the actual components of
the portfolio. See NYSE Arca Equities Rule 8.600(d)(2)(B)(ii).
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    The Commission further believes that the proposed rule change is
reasonably designed to promote fair disclosure of information that may
be necessary to price the Shares appropriately and to prevent trading
when a reasonable degree of transparency cannot be assured. The
Exchange represents that it will obtain a representation from the
issuer of the Shares that the net asset value per share for the Fund
will be calculated daily and that the net asset value and the Disclosed
Portfolio will be made available to all market participants at the same
time.\16\ Additionally, if the Exchange becomes aware that the NAV or
the Disclosed Portfolio is not disseminated daily to all market
participants at the same time, the Exchange will halt trading until
such time as the NAV or the Disclosed Portfolio is available to all
market participants.\17\ Further, if the PIV is not being disseminated
as required, the Exchange may halt trading during the day in which the
interruption occurs; if the interruption persists past the trading day
in which it occurred, the Exchange will halt trading no later than the
beginning of the trading day following the interruption.\18\ The
Exchange represented that the Sub-Adviser is affiliated with multiple
broker-dealers and, accordingly, has implemented a ``fire wall'' with
respect to those broker-dealers regarding access to information
concerning the composition and/or changes to the Fund's portfolio.
Further, the Commission notes that personnel who make decisions on the
open-end fund's portfolio composition must be subject to procedures
designed to prevent the use and dissemination of material nonpublic
information regarding the open-end fund's portfolio.\19\
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    \16\ See NYSE Arca Equities Rule 8.600(d)(1)(B).
    \17\ See NYSE Arca Equities Rule 8.600(d)(2)(D).
    \18\ Id. Trading may also be halted because of market conditions
or for reasons that, in the view of the Exchange, make trading in
the Shares inadvisable. These may include (1) the extent to which
trading is not occurring in the securities comprising the Disclosed
Portfolio and/or the financial instruments of a Fund; or (2) whether
other unusual conditions or circumstances detrimental to the
maintenance of a fair and orderly market are present.
    \19\ See Commentary .06 to NYSE Arca Equities Rule 8.600.
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    The Exchange represented that the Shares are equity securities
subject to the Exchange's rules governing the trading of equity
securities. In support of this proposal, the Exchange has made
representations, including:
    (1) The Shares will be subject to the initial and continued listing
criteria under NYSE Arca Equities Rule 8.600(d).
    (2) The Exchange's surveillance procedures are adequate to properly
monitor Exchange trading of the Shares in all trading sessions and to
deter and detect violations of Exchange rules and applicable Federal
securities laws.
    (3) Before commencement of trading, the Exchange will inform its
ETP Holders in an Information Bulletin of the special characteristics
and risks associated with trading the Shares. Specifically, the
Information Bulletin will discuss the following: (a) The procedures for
purchases and redemptions of shares and that Shares are not
individually redeemable; (b) NYSE Arca Equities Rule 9.2(a), which
imposes a duty of due diligence on its ETP Holders to learn the
essential facts relating to every customer prior to trading the Shares;
(c) the risks involved in trading the Shares during the Opening and
Late Trading Sessions when an updated PIV will not be calculated or
publicly disseminated; (d) how information regarding the PIV is
disseminated; (e) the requirement that ETP Holders deliver a prospectus
to investors purchasing newly issued Shares prior to or concurrently
with the confirmation of a transaction; and (f) trading information.
    (4) The Fund will be in compliance with Rule 10A-3 under the
Act.\20\
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    \20\ 17 CFR 240.10A-3.
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    (5) The Fund will not invest in non-U.S. equity securities.

This approval order is based on the Exchange's representations.
    For the foregoing reasons, the Commission finds that the proposed
rule change is consistent with the Act and the rules and regulations
thereunder applicable to a national securities exchange.

IV. Conclusion

    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\21\ that the proposed rule change (SR-NYSEArca-2010-51) be, and it
hereby is, approved.
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    \21\ 15 U.S.C. 78s(b)(2).

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    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\22\
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    \22\ 17 CFR 200.30-3(a)(12).
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Florence E. Harmon,
Deputy Secretary.
[FR Doc. 2010-19434 Filed 8-5-10; 8:45 am]
BILLING CODE 8010-01-P


[Federal Register Volume 76, Number 116 (Thursday, June 16, 2011)]
[Rules and Regulations]
[Pages 35098-35100]
[FR Doc No: 2011-13951]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 97

[Docket No. 30786; Amdt. No. 3429]

Standard Instrument Approach Procedures, and Takeoff Minimums and
Obstacle Departure Procedures; Miscellaneous Amendments

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: This rule establishes, amends, suspends, or revokes Standard
Instrument Approach Procedures (SIAPs) and associated Takeoff Minimums
and Obstacle Departure Procedures for operations at certain airports.
These regulatory actions are needed because of the adoption of new or
revised criteria, or because of changes occurring in the National
Airspace System, such as the commissioning of new navigational
facilities, adding new obstacles, or changing air traffic requirements.
These changes are designed to provide safe and efficient use of the
navigable airspace and to promote safe flight operations under
instrument flight rules at the affected airports.

DATES: This rule is effective June 16, 2011. The compliance date for
each SIAP, associated Takeoff Minimums, and ODP is specified in the
amendatory provisions.
    The incorporation by reference of certain publications listed in
the regulations is approved by the Director of the Federal Register as
of June 16, 2011.

ADDRESSES: Availability of matter incorporated by reference in the
amendment is as follows:
    For Examination--
    1. FAA Rules Docket, FAA Headquarters Building, 800 Independence
Avenue, SW., Washington, DC 20591;
    2. The FAA Regional Office of the region in which the affected
airport is located;
    3. The National Flight Procedures Office, 6500 South MacArthur
Blvd., Oklahoma City, OK 73169 or
    4. The National Archives and Records Administration (NARA). For
information on the availability of this material at NARA, call 202-741-
6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.
    Availability--All SIAPs are available online free of charge. Visit
http://nfdc.faa.gov to register. Additionally, individual SIAP and
Takeoff Minimums and ODP copies may be obtained from:
    1. FAA Public Inquiry Center (APA-200), FAA Headquarters Building,
800 Independence Avenue, SW., Washington, DC 20591; or
    2. The FAA Regional Office of the region in which the affected
airport is located.

FOR FURTHER INFORMATION CONTACT: Harry J. Hodges, Flight Procedure
Standards Branch (AFS-420)Flight Technologies and Programs Division,
Flight Standards Service, Federal Aviation Administration, Mike
Monroney Aeronautical Center, 6500 South MacArthur Blvd., Oklahoma
City, OK. 73169 (Mail Address: P.O. Box 25082 Oklahoma City, OK 73125)
telephone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: This rule amends Title 14, Code of Federal
Regulations, Part 97 (14 CFR part 97) by amending the referenced SIAPs.
The complete regulatory description of each SIAP is listed on the
appropriate FAA Form 8260, as modified by the National Flight Data
Center (FDC)/Permanent Notice to Airmen (P-NOTAM), and is incorporated
by reference in the amendment under 5 U.S.C. 552(a), 1 CFR part 51, and
Sec.  97.20 of Title 14 of the Code of Federal Regulations.
    The large number of SIAPs, their complex nature, and the need for a
special format make their verbatim publication in the Federal Register
expensive and impractical. Further, airmen do not use the regulatory
text of the SIAPs, but refer to their graphic depiction on charts
printed by publishers of aeronautical materials. Thus, the advantages
of incorporation by reference are realized and publication of the
complete description of each SIAP contained in FAA form documents is
unnecessary. This amendment provides the affected CFR sections and
specifies the types of SIAP and the corresponding effective dates. This
amendment also identifies the airport and its location, the procedure
and the amendment number.

The Rule

    This amendment to 14 CFR part 97 is effective upon publication of
each separate SIAP as amended in the transmittal. For safety and
timeliness of change considerations, this amendment incorporates only
specific changes contained for each SIAP as modified by FDC/P-NOTAMs.
    The SIAPs, as modified by FDC P-NOTAM, and contained in this
amendment are based on the criteria contained in the U.S. Standard for
Terminal Instrument Procedures (TERPS). In developing these changes to
SIAPs, the TERPS criteria were applied only to specific conditions
existing at the affected airports. All SIAP amendments in this rule
have been previously issued by the FAA in a FDC NOTAM as an emergency
action of immediate flight safety relating directly to published
aeronautical charts. The circumstances which created the need for all
these SIAP amendments requires making them effective in less than 30
days.
    Because of the close and immediate relationship between these SIAPs
and safety in air commerce, I find that notice and public procedure
before adopting these SIAPs are impracticable and contrary to the
public interest and,

where applicable, that good cause exists for making these SIAPs
effective in less than 30 days.

Conclusion

    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore--(1) Is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under DOT
regulatory Policies and Procedures (44 FR 11034; February 26, 1979);
and (3) does not warrant preparation of a regulatory evaluation as the
anticipated impact is so minimal. For the same reason, the FAA
certifies that this amendment will not have a significant economic
impact on a substantial number of small entities under the criteria of
the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 97

    Air Traffic Control, Airports, Incorporation by reference, and
Navigation (Air).

    Issued in Washington, DC on May 27, 2011.
Ray Towles,
Deputy Director, Flight Standards Service.

Adoption of the Amendment

    Accordingly, pursuant to the authority delegated to me, Title 14,
Code of Federal regulations, Part 97, 14 CFR part 97, is amended by
amending Standard Instrument Approach Procedures, effective at 0901 UTC
on the dates specified, as follows:

PART 97--STANDARD INSTRUMENT APPROACH PROCEDURES

0
1. The authority citation for part 97 continues to read as follows:

    Authority:  49 U.S.C. 106(g), 40103, 40106, 40113, 40114, 40120,
44502, 44514, 44701, 44719, 44721-44722.

0
2. Part 97 is amended to read as follows:

    Sec. Sec.  97.23, 97.25, 97.27, 97.29, 97.31, 97.33 and 97.35
[Amended]
    By amending: Sec.  97.23 VOR, VOR/DME, VOR or TACAN, and VOR/DME or
TACAN; Sec.  97.25 LOC, LOC/DME, LDA, LDA/DME, SDF, SDF/DME; Sec.
97.27 NDB, NDB/DME; Sec.  97.29 ILS, ILS/DME, MLS, MLS/DME, MLS/RNAV;
Sec.  97.31 RADAR SIAPs; Sec.  97.33 RNAV SIAPs; and Sec.  97.35 COPTER
SIAPs, Identified as follows:

* * * Effective Upon Publication

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      AIRAC date           State              City                 Airport          FDC No.      FDC date                      Subject
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30-Jun-11............  NY             New York............  La Guardia..........       1/0495      5/13/11  RNAV (RNP) Z RWY 4, Orig
30-Jun-11............  NY             White Plains........  Westchester County..       1/0496      5/13/11  RNAV (RNP) Z RWY 16, Orig
30-Jun-11............  FL             Miami...............  Miami Intl..........       1/0524      5/17/11  RNAV (RNP) Y RWY 26L, Orig-A
30-Jun-11............  NY             New York............  La Guardia..........       1/0893      5/13/11  RNAV (RNP) Z RWY 22, Orig-A
30-Jun-11............  NY             White Plains........  Westchester County..       1/0894      5/13/11  RNAV (RNP) Z RWY 34, Orig-A
30-Jun-11............  ME             Sanford.............  Sanford Rgnl........       1/0969       5/6/11  VOR RWY 7, Amdt 4
30-Jun-11............  ME             Sanford.............  Sanford Rgnl........       1/0970       5/6/11  ILS OR LOC RWY 7, Amdt 4
30-Jun-11............  TX             Dallas--Fort Worth..  Dallas/Fort Worth          1/0977       5/9/11  RNAV (RNP) Z RWY 13R, Orig-B
                                                             Intl.
30-Jun-11............  TX             Dallas--Fort Worth..  Dallas/Fort Worth          1/0979       5/9/11  RNAV (RNP) Z RWY 31L, Orig-B
                                                             Intl.
30-Jun-11............  TX             Dallas--Fort Worth..  Dallas/Fort Worth          1/1072       5/9/11  RNAV (RNP) Z RWY 31R, Amdt 1A
                                                             Intl.
30-Jun-11............  AK             Soldotna............  Soldotna............       1/3576      5/19/11  RNAV (GPS) RWY 7, Orig
30-Jun-11............  AK             Soldotna............  Soldotna............       1/3577      5/19/11  RNAV (GPS) RWY 25, Orig
30-Jun-11............  VA             Danville............  Danville Rgnl.......       1/4009      4/25/11  ILS OR LOC RWY 2, Amdt 4
30-Jun-11............  TX             Midland.............  Midland Airpark.....       1/7099      4/28/11  VOR OR GPS A, Amdt 2
30-Jun-11............  TX             Midland.............  Midland Airpark.....       1/7100      4/28/11  VOR/DME OR GPS RWY 25, Amdt 3A
30-Jun-11............  NH             Portsmouth..........  Portsmouth Intl At         1/7109      4/25/11  VOR RWY 16, Amdt 5A
                                                             Pease.
30-Jun-11............  NH             Portsmouth..........  Portsmouth Intl At         1/7110      4/25/11  VOR RWY 34, Orig-C
                                                             Pease.
30-Jun-11............  TX             Lufkin..............  Angelina County.....       1/8830      5/13/11  ILS OR LOC RWY 7, Amdt 2A
30-Jun-11............  SC             Bamberg.............  Bamberg County......       1/9179       5/2/11  RNAV (GPS) RWY 23, Orig
30-Jun-11............  SC             Bamberg.............  Bamberg County......       1/9180       5/2/11  RNAV (GPS) RWY 5, Orig
30-Jun-11............  OK             Norman..............  University of              1/9651       5/6/11  Takeoff Minimums and Obstacle DP, Orig
                                                             Oklahoma Westheimer.
30-Jun-11............  NH             Manchester..........  Manchester..........       1/9793      5/13/11  RNAV (RNP) Z RWY 17, Orig
30-Jun-11............  IL             Chicago.............  Chicago Midway Intl.       1/9795       5/6/11  RNAV (RNP) Y RWY 13C, Amdt 1
30-Jun-11............  CO             Rifle...............  Garfield County Rgnl       1/9796       5/9/11  RNAV (RNP) Z RWY 8, Amdt 1
30-Jun-11............  CO             Rifle...............  Garfield County Rgnl       1/9797       5/9/11  RNAV (RNP) Y RWY 26, Amdt 1
30-Jun-11............  CO             Rifle...............  Garfield County Rgnl       1/9798       5/9/11  RNAV (RNP) Z RWY 26, Amdt 1
30-Jun-11............  OH             Columbus............  Port Columbus Intl..       1/9799       5/9/11  RNAV (RNP) Z RWY 10L, Orig-A
30-Jun-11............  OH             Columbus............  Port Columbus Intl..       1/9800       5/9/11  RNAV (RNP) Z RWY 28R, Orig
30-Jun-11............  OH             Columbus............  Port Columbus Intl..       1/9801       5/9/11  RNAV (RNP) Z RWY 28L, Orig
30-Jun-11............  OH             Columbus............  Port Columbus Intl..       1/9802       5/9/11  RNAV (RNP) Z RWY 10R, Orig
30-Jun-11............  CO             Hayden..............  Yampa Valley........       1/9803       5/9/11  RNAV (RNP) Z RWY 10, Amdt 1
30-Jun-11............  CO             Gunnison............  Gunnison--Crested          1/9804       5/9/11  RNAV (RNP) RWY 6, Orig
                                                             Butte Rgnl.
30-Jun-11............  LA             New Orleans.........  Louis Armstrong New        1/9805       5/6/11  RNAV (RNP) Z RWY 10, Orig
                                                             Orleans Intl.
30-Jun-11............  CO             Gunnison............  Gunnison--Crested          1/9806       5/9/11  RNAV (RNP) RWY 24, Orig
                                                             Butte Rgnl.
30-Jun-11............  LA             New Orleans.........  Louis Armstrong New        1/9807       5/6/11  RNAV (RNP) Z RWY 28, Orig
                                                             Orleans Intl.
30-Jun-11............  TX             Corpus Christi......  Corpus Christi Intl.       1/9809       5/6/11  RNAV (RNP) Z RWY 13, Orig
30-Jun-11............  TX             Lubbock.............  Lubbock Preston            1/9810       5/9/11  RNAV (RNP) Z RWY 35L, Orig
                                                             Smith Intl.
30-Jun-11............  TX             Corpus Christi......  Corpus Christi Intl.       1/9811       5/6/11  RNAV (RNP) Z RWY 35, Orig
30-Jun-11............  TX             Lubbock.............  Lubbock Preston            1/9812       5/9/11  RNAV (RNP) Z RWY 17R, Orig
                                                             Smith Intl.
30-Jun-11............  TX             Corpus Christi......  Corpus Christi Intl.       1/9813       5/6/11  RNAV (RNP) Z RWY 31, Orig

30-Jun-11............  LA             New Orleans.........  Louis Armstrong New        1/9814       5/6/11  RNAV (RNP) Z RWY 19, Orig
                                                             Orleans Intl.
30-Jun-11............  TX             Amarillo............  Rick Husband               1/9815       5/6/11  RNAV (RNP) Z RWY 31, Orig
                                                             Amarillo Intl.
30-Jun-11............  TX             Amarillo............  Rick Husband               1/9822       5/6/11  RNAV (RNP) Z RWY 13, Orig
                                                             Amarillo Intl.
30-Jun-11............  TX             Amarillo............  Rick Husband               1/9823       5/6/11  RNAV (RNP) Z RWY 22, Orig
                                                             Amarillo Intl.
30-Jun-11............  TX             Amarillo............  Rick Husband               1/9824       5/6/11  RNAV (RNP) Z RWY 4, Orig
                                                             Amarillo Intl.
30-Jun-11............  OK             Tulsa...............  Tulsa Intl..........       1/9825       5/9/11  RNAV (RNP) Z RWY 26, Orig
30-Jun-11............  OK             Tulsa...............  Tulsa Intl..........       1/9826       5/9/11  RNAV (RNP) Z RWY 18R, Orig
30-Jun-11............  WY             Jackson.............  Jackson Hole........       1/9832       5/2/11  RNAV (RNP) Y RWY 1, Orig-A
30-Jun-11............  WY             Jackson.............  Jackson Hole........       1/9833       5/2/11  RNAV (RNP) Z RWY 1, Orig-B
30-Jun-11............  WY             Jackson.............  Jackson Hole........       1/9835       5/2/11  RNAV (RNP) Z RWY 19, Orig-A
30-Jun-11............  NJ             Atlantic City.......  Atlantic City Intl..       1/9836      5/13/11  RNAV (RNP) Z RWY 13, Orig
30-Jun-11............  NJ             Atlantic City.......  Atlantic City Intl..       1/9837      5/13/11  RNAV (RNP) Z RWY 31, Orig
30-Jun-11............  OR             North Bend..........  Southwest Rgnl......       1/9838       5/2/11  RNAV (RNP) Z RWY 4, Orig
30-Jun-11............  MT             Bozeman.............  Gallatin Field......       1/9840       5/2/11  RNAV (RNP) RWY 30, Orig
30-Jun-11............  MT             Bozeman.............  Gallatin Field......       1/9841       5/2/11  RNAV (RNP) Z RWY 12, Orig
30-Jun-11............  TN             Nashville...........  Nashville Intl......       1/9849      5/11/11  RNAV (RNP) Z RWY 31, Orig
30-Jun-11............  TN             Nashville...........  Nashville Intl......       1/9850      5/11/11  RNAV (RNP) Z RWY 20R, Orig
30-Jun-11............  MT             Missoula............  Missoula Intl.......       1/9851       5/6/11  RNAV (RNP) RWY 29, Orig
30-Jun-11............  HI             Honolulu............  Honolulu Intl.......       1/9852       5/9/11  RNAV (RNP) Z RWY 4R, Orig
30-Jun-11............  HI             Honolulu............  Honolulu Intl.......       1/9853       5/9/11  RNAV (RNP) RWY 26L, Orig-B
30-Jun-11............  MD             Baltimore...........  Baltimore/Washington       1/9854      5/10/11  RNAV (RNP) Z RWY 15R, Orig-A
                                                             Intl Thurgood
                                                             Marshal.
30-Jun-11............  HI             Honolulu............  Honolulu Intl.......       1/9855       5/9/11  RNAV (RNP) Z RWY 8L, Orig-A
30-Jun-11............  TN             Nashville...........  Nashville Intl......       1/9856      5/11/11  RNAV (RNP) Z RWY 2C, Orig
30-Jun-11............  TN             Nashville...........  Nashville Intl......       1/9857      5/11/11  RNAV (RNP) Z RWY 2L, Orig
30-Jun-11............  TN             Nashville...........  Nashville Intl......       1/9858      5/11/11  RNAV (RNP) Z RWY 2R, Orig
30-Jun-11............  CA             Ontario.............  Ontario Intl........       1/9859       5/6/11  RNAV (RNP) Z RWY 26L, Orig-B
30-Jun-11............  TN             Nashville...........  Nashville Intl......       1/9860      5/11/11  RNAV (RNP) Z RWY 20L, Orig
30-Jun-11............  CA             Ontario.............  Ontario Intl........       1/9861       5/6/11  RNAV (RNP) Z RWY 26R, Orig-B
30-Jun-11............  MD             Baltimore...........  Baltimore/Washington       1/9862      5/10/11  RNAV (RNP) Z RWY 10, Amdt 1
                                                             Intl Thurgood
                                                             Marshal.
30-Jun-11............  MD             Baltimore...........  Baltimore/Washington       1/9863      5/10/11  RNAV (RNP) Z RWY 28, Orig-A
                                                             Intl Thurgood
                                                             Marshal.
30-Jun-11............  MD             Baltimore...........  Baltimore/Washington       1/9864      5/10/11  RNAV (RNP) Z RWY 33L, Amdt 1
                                                             Intl Thurgood
                                                             Marshal.
30-Jun-11............  CA             Ontario.............  Ontario Intl........       1/9865       5/6/11  RNAV (RNP) Z RWY 8L, Orig-B
30-Jun-11............  CA             San Francisco.......  San Francisco Intl..       1/9867      5/11/11  RNAV (RNP) Y RWY 28R, Orig-B
30-Jun-11............  CA             San Francisco.......  San Francisco Intl..       1/9870      5/11/11  RNAV (RNP) Y RWY 10R, Orig
30-Jun-11............  CA             Monterey............  Monterey Peninsula..       1/9878       5/6/11  RNAV (RNP) Z RWY 28L, Orig
30-Jun-11............  CA             San Jose............  Norman Y. Mineta San       1/9884       5/6/11  RNAV (RNP) Z RWY 30L, Amdt 1
                                                             Jose Intl.
30-Jun-11............  CA             San Jose............  Norman Y. Mineta San       1/9886       5/6/11  RNAV (RNP) Z RWY 12L, Orig
                                                             Jose Intl.
30-Jun-11............  CA             San Jose............  Norman Y. Mineta San       1/9889       5/6/11  RNAV (RNP) Z RWY 12R, Amdt 1
                                                             Jose Intl.
30-Jun-11............  CA             San Jose............  Norman Y. Mineta San       1/9890       5/6/11  RNAV (RNP) Z RWY 30R, Orig-A
                                                             Jose Intl.
30-Jun-11............  AZ             Scottsdale..........  Scottsdale..........       1/9912       5/6/11  RNAV (RNP) Y RWY 3, Orig-A
30-Jun-11............  AZ             Scottsdale..........  Scottsdale..........       1/9914       5/6/11  RNAV (RNP) Z RWY 3, Orig
30-Jun-11............  AZ             Scottsdale..........  Scottsdale..........       1/9918       5/6/11  RNAV (RNP) RWY 21, Orig
30-Jun-11............  CA             Bishop..............  Eastern Sierra Rgnl.       1/9920      5/11/11  RNAV (RNP) RWY 30, Orig
30-Jun-11............  GA             Atlanta.............  Dekalb--Peachtree...       1/9924      5/13/11  RNAV (RNP) Z RWY 20L, Orig
30-Jun-11............  PA             Philadelphia........  Philadelphia Intl...       1/9926      5/13/11  RNAV (RNP) Z RWY 9R, Orig
30-Jun-11............  PA             Philadelphia........  Philadelphia Intl...       1/9927      5/13/11  RNAV (RNP) Z RWY 9L, Orig
30-Jun-11............  FL             Sebring.............  Sebring Rgnl........       1/9934      5/13/11  RNAV (RNP) RWY 18, Orig
30-Jun-11............  FL             Tampa...............  Tampa Intl..........       1/9935      5/13/11  RNAV (RNP) Y RWY 19L, Amdt 1
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[FR Doc. 2011-13951 Filed 6-15-11; 8:45 am]
BILLING CODE 4910-13-P