[Federal Register Volume 79, Number 103 (Thursday, May 29, 2014)]
[Notices]
[Pages 30852-30853]
[FR Doc No: 2014-12348]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-0622]

Draft Guidance for Industry on Best Practices in Developing
Proprietary Names for Drugs; 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availability of a draft guidance for industry entitled ``Best Practices
in Developing Proprietary Names for Drugs.'' The draft guidance focuses
on the safety aspects in the development and selection of proposed
proprietary names for all prescription and nonprescription human drug
products and biological products. The draft guidance describes naming
design practices to help avoid medication errors and provides a
qualitative systematic framework for evaluating proprietary names
before submitting them for FDA review. FDA is issuing this draft
guidance to help drug and biologic product sponsors develop proprietary
names that do not cause or contribute to medication errors or otherwise
contribute to the misbranding of the drug.

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 comments 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this draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by July 28, 2014.

ADDRESSES: Submit written requests for single copies of this draft
guidance to the Division of Drug Information, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 2201, Silver Spring, MD 20993-0002; or
the Office of Communication, Outreach and Development, Center for
Biologics Evaluation and Research (CBER), Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-
0002. Send one self-addressed adhesive label to assist that office in
processing your requests. The draft guidance may also be obtained by
calling CBER at 1-800-835-4709 or<PHONE_NUMBER>. See the SUPPLEMENTARY
INFORMATION section for electronic access to the 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    Submit electronic comments on the draft guidance to http://www.regulations.gov.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: Kellie Taylor, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 4418, Silver Spring, MD 20993-0002, 301-
796-0157, or Stephen Ripley, Center for Biologics Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
71, Rm. 7301, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Best Practices in Developing Proprietary Names for Drugs.''
FDA has long recognized the importance of proprietary name confusion as
a potential cause of medication errors, and has addressed this issue
repeatedly in recent decades. Our primary focus has been to develop and
communicate to sponsors a systematic, standardized, and transparent
approach to proprietary name evaluation within the product review and
approval process. As part of this initiative, FDA held public meetings
in June and December 2003 to discuss the methods used for proprietary
name evaluation. In 2007, FDA formally committed to certain performance
goals (under the reauthorization of the Prescription Drug User Fee Act
(PDUFA IV) (Public Law 110-85), including implementing measures to
reduce medication errors related to look-alike and sound-alike
proprietary names (PDUFA IV performance goals). In 2008, FDA held a
public meeting to further discuss testing and evaluating proprietary
names, and initiating a pilot project on proprietary name review. The
2008 meeting focused on advances and current limitations in the science
of proprietary name evaluation, FDA's recommendations for best
practices in the absence of a ``gold standard,'' and details of the
proposed pilot project. The participating expert panel judged all the
evaluation methods proposed by FDA to be complementary and of value in
the proprietary name testing process. We are issuing this guidance in
partial fulfillment of the PDUFA IV performance goals.
    This draft guidance document, which addresses minimizing risks
through the design of drug product naming, is the last in a series of
three guidance documents that FDA is issuing to help sponsors minimize
the potential for medication errors when designing and developing
products. The first draft guidance, published in the Federal Register
on December 13, 2012 (77 FR 74196), focuses on minimizing risks
associated with the design of the drug product and its container
closure system. The second draft guidance, published in the Federal
Register on April 24, 2013 (78 FR 24211), focuses on safety aspects of
the container label and carton labeling design.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the Agency's current thinking on best
practices for developing and selecting proposed proprietary names to
minimize medication errors. It does not create or confer any rights for
or on any person and does not operate to bind FDA or the public. An
alternative approach may be used if such approach satisfies the
requirements of the applicable statutes and regulations.

II. Comments

    Interested persons may submit either electronic comments regarding
this document 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.

III. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
Proprietary name information submitted under 21 CFR part 314 has been
approved under OMB control number 0910-0001, and proprietary name
information submitted under 21 CFR part 601 has been

approved under OMB control number 0910-0338.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm, or http://www.regulations.gov.

    Dated: May 21, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-12348 Filed 5-28-14; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 83, Number 155 (Friday, August 10, 2018)]
[Proposed Rules]
[Pages 39626-39628]
[FR Doc No: 2018-16498]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2018-0642; Product Identifier 2018-NM-087-AD]
RIN 2120-AA64

Airworthiness Directives; Dassault Aviation Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: We propose to adopt a new airworthiness directive (AD) for all
Dassault Aviation Model Falcon 10 airplanes. This proposed AD was
prompted by a determination that more restrictive maintenance
requirements and airworthiness limitations are necessary. This proposed
AD would require revising the maintenance or inspection program, as
applicable, to incorporate new or more restrictive maintenance
requirements and airworthiness limitations. We are proposing this AD to
address the unsafe condition on these products.

DATES: We must receive comments on this proposed AD by September 24,
2018.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    For service information identified in this NPRM, contact Dassault
Falcon Jet Corporation, Teterboro Airport, P.O. Box 2000, South
Hackensack, NJ 07606; telephone<PHONE_NUMBER>; internet http://www.dassaultfalcon.com. You may view this service information at the
FAA, Transport Standards Branch, 2200 South 216th St., Des Moines, WA.
For information on the availability of this material at the FAA, call
206-231-3195.

Examining the AD Docket

    You may examine the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-
0642; or in person at Docket Operations between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays. The AD docket contains
this NPRM, the regulatory evaluation, any comments received, and other
information. The street address for Docket Operations (phone: 800-647-
5527) is in the ADDRESSES section. Comments will be available in the AD
docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Tom Rodriguez, Aerospace Engineer,
International Section, Transport Standards Branch, FAA, 2200 South
216th St., Des Moines, WA 98198; telephone and fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposal. Send your comments to an address listed
under the ADDRESSES section. Include ``Docket No. FAA-2018-0642;
Product Identifier 2018-NM-087-AD'' at the beginning of your comments.
We specifically invite comments on the overall regulatory, economic,
environmental, and energy aspects of this NPRM. We will consider all
comments received by the closing date and may amend this NPRM because
of those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this NPRM.

Discussion

    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Union, has issued EASA AD
2018-0078, dated April 9, 2018 (referred to after this as the Mandatory
Continuing Airworthiness Information, or ``the MCAI''), to correct an
unsafe condition for all Dassault Aviation Model Falcon 10 airplanes.
The MCAI states:

    The airworthiness limitations and certification maintenance
instructions for the Dassault Falcon 10 aeroplanes, which are
approved by EASA, are currently defined and published in the
Dassault Falcon 10 [Airplane Maintenance Manual] AMM, Chapter 5-40.
These instructions have been identified as mandatory for continued
airworthiness.
    Failure to accomplish these instructions could result in an
unsafe condition [fatigue cracking and damage in principal
structural elements, which could result in reduced structural
integrity of the airplane.]
    Previously, EASA issued AD 2008-0221 to require accomplishment
of the maintenance tasks, and implementation of the airworthiness
limitations, as specified in the Dassault Falcon 10 AMM, Chapter 5-
40, at Revision 8.
    Since that [EASA] AD was issued, Dassault issued the
[Airworthiness Limitations Section] ALS, which introduces new and
more restrictive maintenance requirements and/or airworthiness
limitations.
    For the reason described above, this [EASA] AD takes over the
requirements for Falcon 10 aeroplanes from EASA AD 2008-0221, and
requires accomplishment of the actions specified in the ALS.

    You may examine the MCAI in the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-
0642.

Related Service Information Under 1 CFR Part 51

    Dassault has issued Falcon 10 Maintenance Manual, Airworthiness
Limitations, Chapter 5-40-00, Revision 13, dated July 2017. This
service information describes repetitive mandatory maintenance tasks.
This service information is reasonably available because the interested
parties have access to it through their normal course of business or by
the means identified in the ADDRESSES section.

FAA's Determination

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to our bilateral agreement with the State of Design Authority, we have
been notified of the unsafe condition described in the MCAI and service
information referenced above. We are proposing this AD because we
evaluated all the relevant information and determined the unsafe
condition described previously is likely to exist or develop on other
products of the same type design.

Proposed Requirements of This NPRM

    This proposed AD would require accomplishing the actions specified
in the service information described previously, except as discussed
under ``Differences Between this Proposed AD and the MCAI or Service
Information.''
    This AD requires revisions to certain operator maintenance
documents to include new actions (e.g., inspections). Compliance with
these actions is required by 14 CFR 91.403(c). For airplanes that have
been previously modified, altered, or repaired in the areas addressed
by this proposed AD, the operator may not be able to accomplish the
actions described in the revisions. In this situation, to comply with
14 CFR 91.403(c), the operator must request approval for an alternative
method of compliance according to paragraph (i)(1) of this proposed AD.
The request should include a description of changes to the required
actions that will ensure the continued damage tolerance of the affected
structure.

Difference Between This Proposed AD and the MCAI or Service Information

    The MCAI specifies that if there are findings from the
airworthiness limitations section (ALS) inspection tasks, corrective
actions must be accomplished in accordance with Dassault maintenance
documentation. However, this proposed AD does not include that
requirement. Operators of U.S.-registered airplanes are required by
general airworthiness and operational regulations to perform
maintenance using methods that are acceptable to the FAA. We consider
those methods to be adequate to address any corrective actions
necessitated by the findings of ALS inspections required by this
proposed AD.

Costs of Compliance

    We estimate that this proposed AD affects 60 airplanes of U.S.
registry. We estimate the following costs to comply with this proposed
AD:
    We have determined that revising the maintenance or inspection
program takes an average of 90 work-hours per operator, although we
recognize that this number may vary from operator to operator. In the
past, we have estimated that this action takes 1 work-hour per
airplane. Since operators incorporate maintenance or inspection program
changes for their affected fleet(s), we have determined that a per-
operator estimate is more accurate than a per-airplane estimate.
Therefore, we estimate the total cost per operator to be $7,650 (90
work-hours x $85 per work-hour).

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. Subtitle VII: Aviation Programs,
describes in more detail the scope of the Agency's authority.
    We are issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701: ``General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.
    This proposed AD is issued in accordance with authority delegated
by the Executive Director, Aircraft Certification Service, as
authorized by FAA Order 8000.51C. In accordance with that order,
issuance of ADs is normally a function of the Compliance and
Airworthiness Division, but during this transition period, the
Executive Director has delegated the authority to issue ADs applicable
to transport category airplanes to the Director of the System Oversight
Division.

Regulatory Findings

    We determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect on the States, on the relationship
between the national Government and the States, or on the distribution
of power and responsibilities among the various levels of government.
    For the reasons discussed above, I certify this proposed
regulation:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979);
    3. Will not affect intrastate aviation in Alaska; and
    4. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

The Proposed Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA proposes to amend 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority:  49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive (AD):

Dassault Aviation: Docket No. FAA-2018-0642; Product Identifier
2018-NM-087-AD.

(a) Comments Due Date

    We must receive comments by September 24, 2018.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to all Dassault Aviation Model Falcon 10
airplanes, certificated in any category.

(d) Subject

    Air Transport Association (ATA) of America Code 05, Time Limits/
Maintenance Checks.

(e) Reason

    This AD was prompted by a determination that more restrictive
maintenance requirements and airworthiness limitations are
necessary. We are issuing this AD to address, among other things,
fatigue cracking and damage in principal structural elements; such
fatigue cracking and damage could result in reduced structural
integrity of the airplane.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Maintenance or Inspection Program Revision

    Within 90 days after the effective date of this AD, revise the
maintenance or inspection program, as applicable, to incorporate
Falcon 10 Maintenance Manual, Airworthiness Limitations, Chapter 5-
40-00, Revision 13, dated July 2017. The initial compliance time for
accomplishing the actions is at the applicable time specified in
Falcon 10 Maintenance Manual, Airworthiness Limitations, Chapter 5-
40-00, Revision 13, dated July 2017; or within 90 days after the
effective date of this AD; whichever occurs later.

(h) No Alternative Actions or Intervals

    After the maintenance or inspection program has been revised as
required by paragraph (g) of this AD, no alternative actions (e.g.,
inspections) or intervals may be used unless the actions or
intervals are approved as an alternative method of compliance (AMOC)
in accordance with the procedures specified in paragraph (i)(1) of
this AD.

(i) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Section, Transport Standards Branch, FAA, has the
authority to approve AMOCs for this AD, if requested using the
procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19,
send your request to your principal inspector or local Flight
Standards District Office, as appropriate. If sending information
directly to the International Section, send it to the attention of
the person identified in paragraph (j)(2) of this AD. Information
may be emailed to: [email protected]. Before using any
approved AMOC, notify your appropriate principal inspector, or
lacking a principal inspector, the manager of the local flight
standards district office/certificate holding district office.
    (2) Contacting the Manufacturer: For any requirement in this AD
to obtain corrective actions from a manufacturer, the action must be
accomplished using a method approved by the Manager, International
Section, Transport Standards Branch, FAA; or the European Aviation
Safety Agency (EASA); or Dassault Aviation's EASA Design
Organization Approval (DOA). If approved by the DOA, the approval
must include the DOA-authorized signature.

(j) Related Information

    (1) Refer to Mandatory Continuing Airworthiness Information
(MCAI) EASA AD 2018-0078, dated April 9, 2018, for related
information. This MCAI may be found in the AD docket on the internet
at http://www.regulations.gov by searching for and locating Docket
No. FAA-2018-0642.
    (2) For more information about this AD, contact Tom Rodriguez,
Aerospace Engineer, International Section, Transport Standards
Branch, FAA, 2200 South 216th St., Des Moines, WA 98198; telephone
and fax<PHONE_NUMBER>.
    (3) For service information identified in this AD, contact
Dassault Falcon Jet Corporation, Teterboro Airport, P.O. Box 2000,
South Hackensack, NJ 07606; telephone<PHONE_NUMBER>; internet http://www.dassaultfalcon.com. You may view this service information at the
FAA, Transport Standards Branch, 2200 South 216th St., Des Moines,
WA. For information on the availability of this material at the FAA,
call<PHONE_NUMBER>.

    Issued in Des Moines, Washington, on July 24, 2018.
James Cashdollar,
Acting Director, System Oversight Division, Aircraft Certification
Service.
[FR Doc. 2018-16498 Filed 8-9-18; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register: November 24, 2008 (Volume 73, Number 227)]
[Notices]
[Page 71078-71081]
[DOCID:fr24no08-152]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-58965; File No. SR-NYSEArca-2008-127]

Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing
and Order Granting Accelerated Approval of Proposed Rule Change
Relating to the Listing and Trading of Units of the United States Oil
Fund, United States Heating Oil Fund, United States Gasoline Fund,
United States 12 Month Oil Fund, United States 12 Month Natural Gas
Fund, and the United States Natural Gas Fund

 November 17, 2008.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that, on November 5, 2008, NYSE Arca, Inc. (``NYSE Arca'' or
``Exchange'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I and
II below, which Items have been prepared by the Exchange. The
Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons and approving the proposed
rule change on an accelerated basis.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange, through its wholly-owned subsidiary NYSE Arca
Equities, Inc. (``NYSE Arca Equities''), proposes to list the following
Partnership Units (``Units'') pursuant to NYSE Arca Equities Rule
8.300: United States Oil Fund, LP; United States Heating Oil Fund, LP;
United States Gasoline Fund, LP; United States 12 Month Oil Fund, LP;
United States 12 Month Natural Gas Fund, LP; and the United States
Natural Gas Fund, LP (each, a ``Partnership,'' and collectively
``Partnerships''). The text of the proposed rule change is available on
the Exchange's Web site at http://www.nyse.com, at the Exchange's
principal office 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 III 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
    Under NYSE Arca Equities Rule 8.300, the Exchange may propose to
list and trade or trade pursuant to unlisted trading privileges
(``UTP'') Partnership Units (``Units'').\3\ The Exchange proposes to
list and trade the following Units pursuant to NYSE Arca Equities Rule
8.300: United States Oil Fund, LP (``USOF''); United States Heating Oil
Fund, LP (``USHO''); United States Gasoline Fund, LP (``USG''); United
States 12 Month Oil Fund, LP (``12 Month Oil Fund''); United States 12
Month Natural Gas Fund, LP (``12 Month Natural Gas Fund''); and the
United States Natural Gas Fund, LP (``USNG''). The Commission has
previously approved listing of the Partnerships on the NYSE Alternext
US LLC (``NYSE Alternext US'') (formerly, the American Stock Exchange
LLC (``Amex'')) \4\ and trading on the Exchange pursuant to UTP.\5\
Prior to listing on the Exchange, the issuer of the Units would be
required to satisfy the applicable delisting procedures of NYSE
Alternext US and applicable statutory and regulatory requirements,
including, without limitation, Section 12 of the Securities Exchange
Act of 1934 (``Act''),\6\ relating to listing the Units on the
Exchange.\7\
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    \3\ On May 25, 2006, the Commission approved NYSE Arca Equities
Rule 8.300, which sets forth the rules related to listing and
trading criteria for Partnership Units. See Securities Exchange Act
Release No. 53875 (May 25, 2006), 71 FR 32164 (June 2, 2006) (SR-
NYSEArca-2006-11) (approving trading pursuant to UTP of Partnership
Units of the United States Oil Fund, LP).
    \4\ See Securities Exchange Act Release Nos. 53582 (March 31,
2006), 71 FR 17510 (April 6, 2006) (SR-Amex-2005-127) (order
approving Amex listing of USOF); 56831 (November 21, 2007), 72 FR
67612 (November 29, 2007) (SR-Amex-2007-98) (order approving Amex
listing of 12 Month Oil Fund and 12 Month Natural Gas Fund); 55632
(April 13, 2007), 72 FR 19987 (April 20, 2007) (SR-Amex-2006-112)
(order approving Amex listing of USNG); 57188 (January 23, 2008), 73
FR 5607 (January 30, 2008) (SR-Amex-2007-70) (order approving Amex
listing of USHO and USG) (collectively, the ``Amex Filings'').
    \5\ See Securities Exchange Act Release No. 56832 (November 21,
2007), 72 FR 67328 (November 28, 2007) (SR-NYSEArca-2007-102) (order
approving UTP trading of 12 Month Oil Fund and 12 Month Natural Gas
Fund); Securities Exchange Act Release No. 56042 (July 11, 2007), 72
FR 39118 (July 17, 2007) (SR-NYSEArca-2007-45) (order approving UTP
trading of USNG); Securities Exchange Act Release No. 57294
(February 8, 2008), 73 FR 8917 (February 15, 2008) (SR-NYSEArca-
2007-78) (order approving UTP trading of USHO and USG)
(collectively, with the orders cited in note 3, supra, the ``UTP
Filings'').
    \6\ 15 U.S.C. 78(l).
    \7\ The Exchange will seek the voluntary consent of the issuer
of the Units currently listed on NYSE Alternext U.S. to be delisted
from NYSE Alternext U.S. and listed on the Exchange.
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    Descriptions of the Partnerships and the Units are included in the
Amex Filings, the UTP Filings, and the respective Registration
Statements, as amended, for the Units.\8\ The Exchange represents that
the Units satisfy the requirements of Rule 8.300 and thereby qualify
for listing on the Exchange. The Exchange states that all of the facts
describing the Partnerships and the Units contained in the Amex Filings
are true and correct as of the date of this filing. The Exchange states
further that the representations included in the Amex Filings relating
to the dissemination and availability of information regarding the
Units will apply to listing and trading of the Units on the Exchange.
To the extent NYSE

Alternext US has any affirmative obligations with respect to
dissemination of information or key values relating to the Units, the
Exchange represents that it would take the place of NYSE Alternext US
in such role and discharge such obligations.
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    \8\ See USHO's Form S-1, dated April 19, 2007 (File No. 333-
142211); USG's S-1, dated April 18, 2007 (File No. 333-142206); the
12 Month Oil Fund's Form S-1, dated July 5, 2007 (File No. 333-
144348); the 12 Month Natural Gas Fund's S-1, dated July 6, 2007
(File No. 333-144409); USNG's Form S-1, dated October 6, 2006 (File
No. 333-137871); USOF's Form S-1, dated May 16, 2005(File No. 333-
124950).
---------------------------------------------------------------------------

    The Partnerships will comply with the requirements of Rule 10A-3
\9\ under the Act as it applies to limited partnerships.
---------------------------------------------------------------------------

    \9\ 17 CFR 240.10A-3.
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Trading Rules
    The Exchange deems the Units to be equity securities, thus
rendering trading in the Units subject to the Exchange's existing rules
governing the trading of equity securities. Units will trade on the
NYSE Arca Marketplace from 4 a.m. to 8 p.m. ET. The Exchange has
appropriate rules to facilitate transactions in the Units during all
trading sessions. The minimum trading increment for Units on the
Exchange will be $0.01.
    NYSE Arca Equities Rule 8.300(e) sets forth certain restrictions on
ETP Holders acting as registered Market Makers in Units to facilitate
surveillance. NYSE Arca Equities Rule 8.300(e)(2)-(3) requires that the
ETP Holder acting as a registered Market Maker in the Units provide the
Exchange with necessary information relating to its trading in the
underlying asset or commodity, related futures or options on futures,
or any other related derivatives. NYSE Arca Equities Rule 8.300(e)(4)
prohibits the ETP Holder acting as a registered Market Maker in the
Units from using any material nonpublic information received from any
person associated with an ETP Holder or employee of such person
regarding trading by such person or employee in the underlying asset or
commodity, related futures or options on futures or any other related
derivative (including the Units). In addition, NYSE Arca Equities Rule
8.300(e)(1) prohibits the ETP Holder acting as a registered Market
Maker in the Units from being affiliated with a market maker in the
underlying asset or commodity, related futures or options on futures or
any other related derivative unless adequate information barriers are
in place, as provided in NYSE Arca Equities Rule 7.26.
    With respect to trading halts, the Exchange may consider all
relevant factors in exercising its discretion to halt or suspend
trading in the Units. Trading may be halted because of market
conditions or for reasons that, in the view of the Exchange, make
trading in the Units inadvisable. These may include: (1) The extent to
which trading is not occurring in the underlying futures contracts, or
(2) whether other unusual conditions or circumstances detrimental to
the maintenance of a fair and orderly market are present. In addition,
trading in Units could be halted pursuant to the Exchange's ``circuit
breaker'' rule.\10\ Under Rule 7.34(a)(5), if the Exchange becomes
aware that the net asset value (``NAV'') for the Units is not being
disseminated to all market participants at the same time, it will halt
trading in the Units on the Exchange until such time as the NAV is
available to all market participants. In addition, if the portfolio
composition applicable to Units, as disseminated on the Web site for
the Units (as identified in the Amex Filings) is not disseminated to
all market participants at the same time, the Exchange will halt
trading in the affected Units.
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    \10\ See NYSE Arca Equities Rule 7.12.
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Surveillance
    The Exchange intends to utilize its existing surveillance
procedures applicable to derivative products, including Partnership
Units, to monitor trading in the Units. The Exchange represents that
these procedures are adequate to properly monitor Exchange trading of
the Units in all trading sessions and to deter and detect violations of
Exchange rules and applicable federal securities laws.
    The Exchange's current trading surveillances focus on detecting
securities trading outside their normal patterns. When such situations
are detected, surveillance analysis follows and investigations are
opened, where appropriate, to review the behavior of all relevant
parties for all relevant trading violations. The Exchange is able to
obtain information regarding trading in the Units, the applicable
physical commodities included in, or options, futures or options on
futures on, or any other derivatives based on such commodities, through
ETP Holders, in connection with such ETP Holders' proprietary or
customer trades which they effect on any relevant market. With regard
to the petroleum-based and natural gas futures underlying the Units,
the Exchange can obtain market surveillance information, including
customer identity information, with respect to transactions occurring
on the New York Mercantile Exchange and the InterContinental Exchange
pursuant to its comprehensive information sharing agreements with each
of those exchanges. All of the other trading venues on which current
applicable petroleum-based and natural gas futures are traded are
members of the Intermarket Surveillance Group (``ISG'') and the
Exchange therefore has access to all relevant trading information with
respect to those contracts without any further action being required on
the part of the Exchange. A list of ISG members is available at http://
www.isgportal.org.
    In addition, to the extent that a Partnership invests in petroleum-
based, natural gas and similar futures contracts traded on other
exchanges, not more than 10% of the weight of the Partnership assets in
the aggregate shall consist of such futures contracts whose principal
trading market is not a member of ISG or is a market with which the
Exchange does not have a comprehensive surveillance sharing agreement.
    The Exchange also has a general policy prohibiting the distribution
of material, non-public information by its employees.
Information Bulletin
    Prior to the commencement of trading, the Exchange will inform its
ETP Holders in an Information Bulletin (``Bulletin'') of the special
characteristics and risks associated with trading the Units.
Specifically, the Bulletin will discuss the following: (1) The risks
involved in trading the Units during the Opening and Late Trading
Sessions when an updated Indicative Partnership Value will not be
calculated or publicly disseminated; (2) the procedures for purchases
and redemptions of Units (and that Units are not individually
redeemable); (3) 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 Units; (4) how
information regarding the Indicative Partnership Value is disseminated;
(5) the requirement that ETP Holders deliver a prospectus to investors
purchasing newly issued Units prior to or concurrently with the
confirmation of a transaction; and (6) trading information.
    In addition, the Bulletin will reference that each Partnership is
subject to various fees and expenses described in the relevant
registration statement.
    The Bulletin will also reference the fact that there is no
regulated source of last sale information regarding physical
commodities, that the Commission has no jurisdiction over the trading
of heating oil, gasoline, crude oil, natural gas or petroleum-based
fuels, and that the CFTC has regulatory jurisdiction over the trading
of petroleum-based and natural gas futures contracts and related
options.

    The Bulletin will also discuss any exemptive, no-action and
interpretive relief granted by the Commission from any rules under the
Act.
    The Bulletin will also disclose that the NAV for the Units will be
calculated after 4:00 p.m. ET each trading day.
2. Statutory Basis
    The proposed rule change is consistent with Section 6(b) of the
Act,\11\ in general, and furthers the objectives of Section
6(b)(5),\12\ 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, and to
remove impediments to and perfect the mechanism of a free and open
market and a national market system. The Exchange believes that the
proposed rule change will permit the listing of the Units on the
Exchange, to the benefit of investors and the marketplace. In addition,
the listing and trading criteria set forth in Rule 8.300 are intended
to protect investors and the public interest.
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    \11\ 15 U.S.C. 78f(b).
    \12\ 15 U.S.C. 78f(b)(5).
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B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
impose any burden on competition 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. 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-NYSEArca-2008-127 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-NYSEArca-2008-127. 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-NYSEArca-2008-127 and should
be submitted on or before December 15, 2008.

IV. Commission's Findings and Order Granting Accelerated Approval of
the Proposed Rule Change

    After careful consideration, the Commission finds that the proposed
rule change is consistent with the requirements of the Act and the
rules and regulations thereunder applicable to a national securities
exchange.\13\ In particular, the Commission believes that the proposal
is consistent with Section 6(b)(5) of the Act,\14\ which requires,
among other things, that the rules of a national securities exchange be
designed to promote just and equitable principles of trade, to remove
impediments to and perfect the mechanism of a free and open market and
a national market system, and in general, to protect investors and the
public interest. The Commission notes that it has approved the listing
and trading of the Units on Amex,\15\ now known as NYSE Alternext US,
and the trading of the Units pursuant to UTP on the Exchange.\16\
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    \13\ In approving this rule change, the Commission notes that it
has considered the proposed rule's impact on efficiency,
competition, and capital formation. See 15 U.S.C. 78c(f).
    \14\ 15 U.S.C. 78f(b)(5).
    \15\ See Amex Filings, supra, note 4.
    \16\ See UTP Filings, supra, note 5.
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    The Commission believes that the proposal to list and trade the
Units on the Exchange is consistent with Section 11A(a)(1)(C)(iii) of
the Act,\17\ 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. The Exchange has stated
that the representations included in the Amex Filings relating to the
dissemination and availability of information regarding the Units will
apply to the listing and trading of the Units on the Exchange, and, to
the extent NYSE Alternext U.S. (formerly Amex) has any affirmative
obligations with respect to dissemination of information or key values
relating to the Units, the Exchange represents that it would take the
place of NYSE Alternext U.S. in such role and discharge such
obligations.\18\ The Commission notes that, at a minimum, the Units
must comply with NYSE Arca Equities Rules 8.300(d)(2)(ii) and (iii),
which relate to the regular dissemination of the value of the
underlying benchmark investment, commodity, or asset and the Indicative
Partnership Value, respectively, for continued trading of the Units on
the Exchange.
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    \17\ 15 U.S.C. 78k-1(a)(1)(C)(iii).
    \18\ See Amex Filings, supra, note 4.
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    The Commission also believes that the proposal to list and trade
the Units is reasonably designed to promote fair disclosure of
information that may be necessary to price the Units appropriately and
to prevent trading when a reasonable degree of transparency cannot be
assured. The Commission notes that, under NYSE Arca Equities Rule
7.34(a)(5), if the Exchange becomes aware that the NAV for the Units is
not being disseminated to all market participants at the same time, it
will halt trading in the Units on the Exchange until such time as the
NAV is available to all market participants. In addition, if the
portfolio composition applicable to the Units, as disseminated on the
Web site for the Units (as identified in the Amex Filings), is not
disseminated to all

market participants at the same time, the Exchange will halt trading in
the affected Units. Moreover, NYSE Arca Equities Rule 8.300(e) limits
certain dealings and trading activity of ETP Holders acting as
registered Market Makers in Units, prescribes various recordkeeping and
disclosure requirements for ETP Holders, and prohibits the use of any
material non-public information regarding trading in the underlying
physical asset or commodity, futures or options on futures, or any
other related derivatives.
    The Commission further believes that the trading rules and
procedures to which the Units will be subject pursuant to this proposal
are consistent with the Act. The Exchange has represented that the
Units are equity securities subject to NYSE Arca's rules governing the
trading of equity securities.
    In support of this proposal, the Exchange has made the following
representations:
    (1) The Units satisfy the requirements of NYSE Arca Equities Rule
8.300, which includes the initial and continued listing criteria for
Partnership Units.
    (2) The Exchange's surveillance procedures are adequate to properly
monitor trading of the Units in all trading sessions and to deter and
detect violations of Exchange rules and applicable federal securities
laws.
    (3) The Exchange will distribute an Information Bulletin, the
contents of which are more fully described above, to its ETP Holders in
connection with the trading of the Units.
    (4) The Partnerships will comply with the requirements of Rule 10A-
3 under the Act \19\ as it applies to limited partnerships.
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    \19\ 17 CFR 240.10A-3.
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    This approval order is based on the Exchange's representations.
    The Commission finds good cause, pursuant to Section 19(b)(2) of
the Act,\20\ for approving the proposed rule change prior to the 30th
day after the date of publication of notice in the Federal Register.
The Commission notes that it has previously approved the listing and
trading of the Units on Amex \21\ and believes that the Exchange's
proposal to list and trade such Units does not appear to present any
novel or significant regulatory issues. As such, the Commission
believes that accelerating approval of this proposal should benefit
investors by creating, without undue delay, additional competition in
the market for such products.
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    \20\ 15 U.S.C. 78s(b)(2).
    \21\ See Amex Filings, supra, note 4. The Units have also been
approved for trading on the Exchange pursuant to UTP. See UTP
Filings, supra, note 5.
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V. Conclusion

    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\22\ that the proposed rule change (SR-NYSEArca-2008-127) be, and
it hereby is, approved on an accelerated basis.
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    \22\ 15 U.S.C. 78s(b)(2).
    \23\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\23\
Florence E. Harmon,
Acting Secretary.
[FR Doc. E8-27880 Filed 11-21-08; 8:45 am]

BILLING CODE 8011-01-P