[Federal Register: July 22, 2009 (Volume 74, Number 139)]
[Notices]
[Page 36196-36198]
[DOCID:fr22jy09-62]

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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2003-0010; FRL-8426-6]

1,2-Ethylene Dichloride; Completion of EPA Program Review

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: EPA issued a testing consent order that incorporated an
enforceable consent agreement (ECA) for 1,2-Ethylene Dichloride (EDC)
in June 2003, using authorities under section 4 of the Toxic Substances
Control Act (TSCA). The companies subject to the ECA agreed to conduct
toxicity testing in a tiered testing program that included development
of pharmacokinetics and mechanistic data and a computational dosimetry
model for route-to-route extrapolations. The testing program was
designed to satisfy the toxicological data needs for EDC identified in
a TSCA section 4 proposed test rule for a number of hazardous air
pollutant chemicals. The modeling is intended to allow toxicological
studies conducted using oral exposures to be interpreted so that they
could also be used to predict the effects of inhalation exposures. This
notice announces the completion of the program review component of the
ECA for EDC. This notice also states EPA's findings and conclusion
regarding the adequacy of the derived models to perform satisfactory
route-to-route extrapolations, responds to comments on the Tier I
Program Review Testing, and establishes revised deadlines for
completion of Tier II testing and computational route-to-route
dosimetry modeling for extrapolations listed under Tier II of the ECA
for EDC.

FOR FURTHER INFORMATION CONTACT: For general information contact: Colby
Lintner, Regulatory Coordinator, Environmental Assistance Division
(7408M), Office of Pollution Prevention and Toxics, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number:<PHONE_NUMBER>; e-mail address: TSCA-
<EMAIL_ADDRESS>    For technical information contact: John Schaeffer, Chemical Control
Division (7405M), Office Pollution Prevention and Toxics, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number:<PHONE_NUMBER>; e-mail address:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    This action is directed to the public in general, and may be of
particular interest to those persons who are or may be required to
conduct testing of chemical substances under TSCA. Since other entities
may also be interested, the Agency has not attempted to describe all
the specific entities that may be affected by this action. If you have
any questions regarding the applicability of this action to a
particular entity, consult the technical person listed under FOR
FURTHER INFORMATION CONTACT.

B. How Can I Get Copies of this Document and Other Related Information?

    1. Docket. EPA has established a docket for this action under
docket identification (ID) number EPA-HQ-OPPT-2003-0010. All documents
in the docket are listed in the docket index available at http://
www.regulations.gov. Although listed in the index, some information is
not publicly available, e.g., Confidential Business Information (CBI)
or other information whose disclosure is restricted by statute. Certain
other material, such as copyrighted material, will be publicly
available only in hard copy. Publicly available docket materials are
available electronically at http://www.regulations.gov, or, if only
available in hard copy, at the OPPT Docket. The OPPT Docket is located
in the EPA Docket Center (EPA/DC) at Rm. 3334, EPA West Bldg., 1301
Constitution Ave., NW., Washington, DC. The EPA/DC Public Reading Room
hours of operation are 8:30 a.m. to 4:30 p.m., Monday through Friday,
excluding Federal holidays. The telephone number of the EPA/DC Public
Reading Room is<PHONE_NUMBER>, and the telephone number for the OPPT
Docket is<PHONE_NUMBER>. Docket visitors are required to show
photographic identification, pass through a metal detector, and sign
the EPA visitor log. All visitor bags are processed through an X-ray
machine and subject to search. Visitors will be provided an EPA/DC
badge that must be visible at all times in the building and returned
upon departure.
    2. Electronic access. You may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr.

II. Background

 A. What is the EPA Program Review for EDC?

    In the Federal Register of September 5, 2006 (71 FR 52329) (FRL-
8088-3), EPA announced that it was conducting the program review
component of the ECA for the EDC alternative testing program, and
solicited public comment on data received under the Tier I Program
Review testing segment of the ECA for EDC (CAS No. 107-06-2). Comments
were to inform EPA's decision on whether or not additional data and/or
model development are needed before Tier II testing and computational
route-to-route dosimetry modeling extrapolations could proceed for the
Tier II endpoints listed in the ECA for EDC. Details of the testing
program for EDC are available in the ECA and in the Federal Register of
June 3, 2003 (68 FR 33125) (FRL-7300-6), in which EPA announced it had
entered into an ECA and issued a testing consent order for EDC. The ECA
for EDC was developed in response to EPA's request for ECA proposal for
health effects testing of a number of hazardous air pollutants (HAPs or
HAP chemicals), including EDC (see the proposed test rule in the
Federal Register of June 26, 1996 (61 FR 33177) (FRL-4869-1), and the
proposed test rule, as amended, in the Federal Register of December 24,
1997 (62 FR 67466) (FRL-5742-2); February 5, 1998 (63 FR 5915) (FRL-
5769-3); and April 21, 1998 (63 FR 19694) (FRL-5780-6)). The HAPs
rulemaking proposed testing for health effects by the inhalation route
of exposure. In the proposed rule, EPA also invited the submission of
proposals that included pharmacokinetics studies and model development
that would permit the extrapolation of testing administered by other
exposure routes, such as the oral route, to predict for inhalation
exposures. On November 22, 1996, Dow Chemical Company, Vulcan Materials
Company (no longer in existence), Occidental Chemical Corporation, Oxy
Vinyls, LP, Georgia Gulf Corporation, Westlake Chemical Corporation,
PPG Industries, Inc., and Formosa Plastics Corporation, U.S.A. (the
``Companies''), under the auspices of the HAP Task Force, submitted a
proposal for alternative testing of EDC that included physiologically
based pharmacokinetics (PBPK) and model development to support route-
to-route extrapolation of testing to be conducted under the ECA by the
oral route. EPA considered this proposal sufficient to enter into ECA
negotiations with the Companies and other interested parties (62 FR
66626; December 19, 1997) (FRL-5763-1). The ECA for EDC that resulted
was announced in the Federal Register of June 3, 2003 (68 FR 33125).
Since the route-to-route extrapolation of test results was a new
approach, EPA and the Companies included a program review step within
the testing program. The testing program consists of Tier I HAPs
Testing; Tier I Program Review Testing; EPA Program Review; and Tier II
Testing.
    Tier I HAPs Testing consisted of endpoint testing conducted by
inhalation exposure for acute toxicity, with bronchoalveolar lavage
(BAL) and histopathology, and acute neurotoxicity. The Tier I Program
Review Testing consisted of studies to develop PK/MECH data, analyze
glutathione metabolism, and perform model simulation. These studies
were conducted to extend the computational dosimetry model of D'Souza
et al. (1987, 1988; Refs. 1 and 2) to improve the model's application
to the specific health effects endpoints for EDC listed in the ECA. The
studies also enabled EPA to validate the model and verify the model's
ability to adequately perform quantitative route-to-route
extrapolations of dose response. Further description of the Tier I HAPs
Testing and the Tier I Program Review Testing is provided in the
Federal Register of September 5, 2006 (71 FR 52329). That notice, as
well as the final study reports, can be accessed in the docket (EPA-HQ-
OPPT-2003-0010) as explained in Unit I.B.
    As specified in the ECA, the EPA program review is required before
the Tier II Testing segment is undertaken. In the Federal Register of
September 5, 2006 (71 FR 52329), EPA announced that it was conducting
the program review component of the ECA for EDC, and solicited public
comment on data received under the Tier I Program Review Testing
segment of the ECA. Comments were to inform EPA's decision on whether
or not additional data and/or model development were needed before Tier
II Testing and computational route-to-route dosimetry modeling
extrapolations can proceed for the Tier II endpoints listed in the ECA
for EDC.

B. What were the Public Comments on the Tier I Program Review Testing
for EDC?

    EPA received two public comments in response to its solicitation
for comments on the Tier I Program Review Testing. Comments from People
for the Ethical Treatment of Animals (PETA) were on behalf of
themselves and the following organizations: The Physicians' Committee
for Responsible Medicine, the Humane Society of the United States, the
Doris Day Animal League, and Earth Island Institute. PETA expressed
support for the use of PBPK modeling to limit additional animal testing
through the use of route-to-route extrapolation to existing studies.
However, PETA also stated that they disagreed that additional Tier II
tests (i.e., for reproductive effect or subchronic neurotoxicity) are
needed; contending that existing studies for these effects are
adequate. EPA disagrees, and its basis for requiring this additional
testing is discussed in previous Federal Register documents, cited in
Unit II.A. A second comment, from a private citizen, was focused on
opposition to the manufacture of chlorine compounds in general,
including EDC, and not the testing program.

C. What are the Conclusions of the EPA Tier I Program Review Testing
for EDC?

    The companies have completed the Tier I and Tier I Program Review
testing segments of the ECA for EDC. The companies have also examined
additional PBPK models and other available information in order to more
fully update the model developed by D'Souza et al., 1987, 1988; as
specified in the ECA agreement. The results of this work, the updated
model, and model simulations have been discussed with EPA (Refs. 3
through 6) and have also been recently published as a peer-reviewed
article in the scientific literature (Ref. 7). It is EPA's conclusion
that the PBPK model developed by the test sponsors under the EDC ECA is
acceptable for route-to-route extrapolations and that Tier II testing
and extrapolation reporting can proceed as per the schedule set forth
below (Ref. 8). Specifically, EPA concludes that:
    1. The PK/MECH data report and Tier I toxicity studies have been
conducted in accordance with the protocols and specifications as
described in Appendix C of the ECA.
    2. The available study records are sufficient to allow an
evaluation of the quality of the studies performed.
    3. The EDC PBPK model is appropriately chemical-specific, and
suitably based on the current understanding of the kinetics of EDC.
    4. The species, dose level, exposure regimens, and vehicles used
are relevant for the toxicity data that are the object of the Tier II
extrapolations.
    5. The Tier I Program Review PK/MECH data, along with additional
data, show that periodicity was demonstrated and that the various data
sets bearing on the issue of periodicity can be properly

interpreted and managed in the studies that support the model.
    6. Refinements of the model related to absorption, tissue
distribution, and metabolism were accomplished, or suitably explained,
including the role of extrahepatic metabolism as it impacts the model
dose metrics and route-to-route extrapolation; appreciably improving
prior PBPK models of EDC.
    It is EPA's decision that the HAP Task Force can proceed with the
Tier II Testing under the schedule set forth in Table 1. of this
Federal Register document.

                 Table 1.--Required Testing, Test Standards, and Reporting Requirements for EDC
----------------------------------------------------------------------------------------------------------------
                                                                                Deadline for final
           Testing segment                 Required testing          Test standard          report\1\ (months)
----------------------------------------------------------------------------------------------------------------

Tier II testing and/or extrapolation   Subchronic toxicity      ECA appendix C.2 and     12
 reporting                              route-to-route           C.6
                                        extrapolation of dose-
                                        response (oral Tier II
                                        testing to inhalation)
                                        of a study reported by
                                        Daniel, et al., (1994)

                                       Subchronic               40 CFR 799.9620 (as      18
                                        neurotoxicity (oral)     annotated in ECA
                                                                 appendix D.2)

                                       Subchronic               ECA appendix C.3 and     21
                                        neurotoxicity route-to-  C.6
                                        route extrapolation of
                                        dose-response (oral
                                        Tier II testing to
                                        inhalation)

                                       Reproductive toxicity    40 CFR 799.9380 (as      25
                                        (oral)                   annotated in ECA
                                                                 appendix D.3)

                                       Reproductive toxicity    ECA appendix C.4 and     28
                                        route-to-route           C.6
                                        extrapolation of dose-
                                        response (oral data to
                                        inhalation, including
                                        Tier II testing and
                                        extant studies
                                        reported by Alumot, et
                                        al., (1976), Rao, et
                                        al., (1980), and Lane,
                                        et al., (1982))
----------------------------------------------------------------------------------------------------------------
\1\Number of months after the date of publication of this Federal Register document, which announces that EPA
  has concluded the EPA Program Review, when the final report is due. In addition, every 6 months from the
  effective date of the Order until the end of the ECA testing program, interim reports describing the status of
  all testing to be performed under this ECA must be submitted by the Companies to EPA.

III. References

    1. D'Souza, R.W., Francis, W.R., Bruce R.D., and Andersen, M.E.
Physiologically based pharmacokinetic model for ethylene dichloride and
its application in risk assessment. P. 286-301, In: Pharmacokinetics in
Risk Assessment. National Academy Press. Washington, D.C. (1987).
    2. D'Souza, R.W., Francis, W.R., and Andersen, M.E. Physiological
model for tissue glutathione depletion and increased resynthesis after
ethylene dichloride exposure. Journal of Pharmacology and Experimental
Therapeutics. 245(2):563-568. (1988).
    3. EPA, Office of Prevention, Pesticides and Toxic Substances,
Chemical Control Division. Letter from Jim Willis, Director, CCD to Dr.
Peter Voytek, HAP Task Force. RE: EPA Tier I Program Review for EDC.
January 10, 2007.
    4. EPA and HAP Task Force. Technical Consultation Meeting on 1, 2-
Ethylene Dichloride Program Review. February 12, 2007.
    5. HAP Task Force. Letter from Peter E. Voytek, Manager, HAP Task
Force to Jim Willis, Director, Chemical Control Division, Office of
Pollution Prevention and Toxics, with Enclosure: Response to Issues
Raised in EPA's Tier 1 Data Evaluation Meeting. May 23, 2007.
    6. Sweeny, L. M. and Gargas, M.I. Physiologically based
pharmacokinetic model development and simulations for ethylene
dichloride (1,2-dichlorethane) in rats. Prepared by the Sapphire Group,
Dayton Ohio for the HAP Task Force, Millwood, Virginia. Revised Draft
Report. March 11, 2009.
    7. Sweeny, L. M., Saghir, S. A., and Gargas, M.I. Physiologically
based pharmacokinetic model development and simulations for ethylene
dichloride (1,2-dichlorethane) in rats. Regulatory Toxicology and
Pharmacology. 51:311-323. (2008).
    8. EPA. Email from Rob Dewoskin, PhD, DABT, US EPA/NCEA (National
Center for Environmental Assessment) to John Schaeffer. Review of Final
report - EDC ECA Program Review Completion. April 22, 2009.

List of Subjects

    Environmental protection, 1,2-Ethylene Dichloride, EDC, Hazardous
chemicals.

    Dated: July 10, 2009.
Jim Willis,
Director, Chemical Control Division, Office of Pollution Prevention and
Toxics.

[FR Doc. E9-17170 Filed 7-21-09; 8:45 am]

BILLING CODE 6560-50-S


[Federal Register: October 17, 2005 (Volume 70, Number 199)]
[Notices]
[Page 60332-60333]
[DOCID:fr17oc05-83]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Notice of Application for Amendment of License and Soliciting
Comments, Motions To Intervene, and Protests

October 11, 2005.
    Take notice that the following application has been filed with the
Commission and is available for public inspection:
    a. Application Type: Amendment of license.
    b. Project No: 20-065.
    c. Date Filed: August 16, 2005.
    d. Applicant: PacifiCorp.
    e. Name of Project: Cove Development.
    f. Location: The project is located on the Bear River in Caribou
and Franklin Counties, Idaho.
    g. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791a-825r.
    h. Applicant Contacts: Monte Garrett, Project Manager, PacifiCorp,
1500 Lloyd Center Tower, 825 NE. Multnomah Street, Portland, OR 97232-
2135. Telephone:<PHONE_NUMBER>.
    i. FERC Contact: Any questions on this notice should be addressed
to Mr. Hong Tung at<PHONE_NUMBER>, or e-mail address:
<EMAIL_ADDRESS>
    j. Deadline for filing comments and or motions: November 14, 2005.
    k. Description of Request: The licensee proposes to amend the
project license to remove the Cove Development, and to reduce minimum
flow requirements in the Grace Development bypassed reach. The licensee
states that removal of the Cove Development in accordance with the
terms of the Offer of Settlement would enhance environmental resources
in the project area, and reductions in Grace Development bypassed reach
minimum flows would partially offset the cost of Cove Development
removal.
    l. Locations of Applications: A copy of the application is
available for inspection and reproduction at the Commission in the
Public Reference Room, located at 888 First Street, NE., Room 2A,
Washington, DC 20426, or by calling<PHONE_NUMBER>. This filing may
also be viewed on the Commission's Web site at http://www.ferc.gov

using the ``eLibrary'' link. Enter the docket number excluding the last
three digits in the docket number field to access the document. You may
also register online at http://www.ferc.gov/docs-filing/esubscription.asp
 to be notified via e-mail of new filings and

issuances related to this or other pending projects. For assistance,
call toll-free 1-866-208-3676 or e-mail<EMAIL_ADDRESS>For
TTY, call<PHONE_NUMBER>. A copy is also available for inspection and
reproduction at the address in item (h) above.
    m. Individuals desiring to be included on the Commission's mailing
list should so indicate by writing to the Secretary of the Commission.
    n. Comments, Protests, or Motions to Intervene--Anyone may submit
comments, a protest, or a motion to intervene in accordance with the
requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211,
.214. In determining the appropriate action to take, the Commission
will consider all protests or other comments filed, but only those who
file a motion to intervene in accordance with the Commission's Rules
may become a party to the proceeding. Any comments, protests, or
motions to intervene must be received on or before the specified

comment date for the particular application.
    o. Filing and Service of Responsive Documents--Any filings must
bear in all capital letters the title ``COMMENTS'', ``RECOMMENDATIONS
FOR TERMS AND CONDITIONS'', ``PROTEST'', OR ``MOTION TO INTERVENE'', as
applicable, and the Project Number of the particular application to
which the filing refers. All documents (original and eight copies)
should be filed with: Magalie R. Salas, Secretary, Federal Energy
Regulatory Commission, 888 First Street, NE., Washington, DC 20426. A
copy of any motion to intervene must also be served upon each
representative of the Applicant specified in the particular
application.
    p. Agency Comments--Federal, State, and local agencies are invited
to file comments on the described application. A copy of the
application may be obtained by agencies directly from the Applicant. If
an agency does not file comments within the time specified for filing
comments, it will be presumed to have no comments. One copy of an
agency's comments must also be sent to the Applicant's representatives.
    q. Comments, protests and interventions may be filed electronically
via the Internet in lieu of paper. See, 18 CFR 385.2001(a)(1)(iii) and
the instructions on the Commission's Web site at http://www.ferc.gov

under the ``e-Filing'' link.

Magalie R. Salas,
Secretary.
[FR Doc. E5-5700 Filed 10-14-05; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 77, Number 190 (Monday, October 1, 2012)]
[Notices]
[Pages 60005-60006]
[FR Doc No: 2012-23954]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

[AC 187-1F]

Schedule of Charges Outside the United States

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of availability.

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

SUMMARY: The Federal Aviation Administration (FAA) is announcing the
availability of Advisory Circular (AC) 187-1F which transmits an
updated schedule of charges for services of FAA Flight Standards
Aviation Safety Inspectors outside the United States. The advisory
circular has been updated in accordance with the procedures listed in
14 CFR Part 187, Appendix A.

DATES: This AC is effective on October 1, 2012.

ADDRESSES: How to obtain copies: A copy of this publication may be
downloaded from: http://www.faa.gov/documentLibrary/media/Advisory_Circular/.pdf

FOR FURTHER INFORMATION CONTACT: Ms. Tish Thompkins-Imafidon, Flight
Standards Service, AFS-50, Federal Aviation Administration, 800
Independence Avenue SW., Washington, DC 20591, telephone (202) 385-
8097.

    Issued in Washington, DC, on September 25, 2012.
Raymond Towles,
Deputy Director, Flight Standards Service.
[FR Doc. 2012-23954 Filed 9-28-12; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 78, Number 98 (Tuesday, May 21, 2013)]
[Notices]
[Page 29760]
[FR Doc No: 2013-12004]

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

DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-3364-EM; Docket ID FEMA-2012-0002]

North Dakota; Amendment No. 1 to Notice of an Emergency
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: This notice amends the notice of an emergency declaration for
the State of North Dakota (FEMA-3364-EM), dated April 26, 2013, and
related determinations.

DATES: Effective Date: May 7, 2013.

FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW.,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Notice is hereby given that the incident
period for this emergency is closed effective May 7, 2013.

(The following Catalog of Federal Domestic Assistance Numbers (CFDA)
are to be used for reporting and drawing funds: 97.030, Community
Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling;
97.033, Disaster Legal Services; 97.034, Disaster Unemployment
Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048,
Disaster Housing Assistance to Individuals and Households in
Presidentially Declared Disaster Areas; 97.049, Presidentially
Declared Disaster Assistance--Disaster Housing Operations for
Individuals and Households; 97.050, Presidentially Declared Disaster
Assistance to Individuals and Households--Other Needs; 97.036,
Disaster Grants--Public Assistance (Presidentially Declared
Disasters); 97.039, Hazard Mitigation Grant.)

W. Craig Fugate,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2013-12004 Filed 5-20-13; 8:45 am]
BILLING CODE 9111-23-P


here are some of the key points of my review:
 Selection for heavy metal resistant organisms
 Does chelation matter.  The published studies of the use of copper clad/copper coated materials in the healthcare setting do not appear to use chelators so unclear whether their results are being influenced by copper ion carrier-over into their recovery media.
 EPA method does mention chelation but lacks details of what should be used.  There might be a benefit to run a validation study to evaluate whether chelation makes a difference in the culture method thereby influencing log recovery.
 Drying of inocula on surface will yield some loss of test organisms and may not be able to be teased out from the activity of copper even with using the stainless steel coupon controls.  That said a 1 hr dry time may not yield significant loss of test organism.
 With other antimicrobial agent impregnated materials one could use the unimpregnated (same base material) as a control.
 With regards to porous materials.  We still need a universally agreed upon protocol (even for non-impregnated materials).  Results would have to translatable and not impacted by the microbial recovery issues.


[Federal Register Volume 82, Number 126 (Monday, July 3, 2017)]
[Rules and Regulations]
[Page 30736]
[FR Doc No: 2017-13563]

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

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2017-0561]

Safety Zones; Cornucopia 4th of July Fireworks Display, Siskiwit
Bay, Cornucopia, WI

AGENCY: Coast Guard, DHS.

ACTION: Notice of enforcement of regulation.

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

SUMMARY: The Coast Guard will enforce the safety zone for the
Cornucopia 4th of July Fireworks Display in Cornucopia, WI from 9:30
p.m. through 11:00 p.m. on July 1, 2017. This action is necessary to
protect participants and spectators during the Cornucopia 4th of July
Fireworks Display. During the enforcement period, entry into,
transiting, or anchoring within the safety zone is prohibited unless
authorized by the Captain of the Port Duluth or her designated on-scene
representative.

DATES: The regulations in 33 CFR 165.943(a)(4) and (b) will be enforced
from 9:30 p.m. through 11:00 p.m. on July 1, 2017, for the Cornucopia
4th of July Fireworks Display safety zone, located in Sec.
165.943(a)(4).

FOR FURTHER INFORMATION CONTACT: If you have questions on this
document, call or email LT John Mack, Chief of Waterways Management,
Coast Guard; telephone<PHONE_NUMBER>, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The Coast Guard will enforce the safety zone
for the annual Cornucopia 4th of July Fireworks Display in 33 CFR
165.943(a)(4) and (b) from 9:30 p.m. through 11:00 p.m. on July 1, 2017
on all waters of Siskiwit Bay bounded by the arc of a circle with a
420-foot radius from the fireworks launch site with it center in
position 46[deg]51'35'' N., 091[deg]06'15'' W.
    Entry into, transiting, or anchoring within the safety zone is
prohibited unless authorized by the Captain of the Port Duluth or her
designated on-scene representative. The Captain of the Port's
designated on-scene representative may be contacted via VHF Channel 16
or via telephone at<PHONE_NUMBER>. This document is issued under
authority of 33 CFR 165.943 and 5 U.S.C. 552(a). In addition to this
publication in the Federal Register, the Coast Guard will provide the
maritime community with advance notification of the enforcement of this
safety zone via Broadcast Notice to Mariners. The Captain of the Port
Duluth or her on-scene representative may be contacted via VHF Channel
16 or via telephone at<PHONE_NUMBER>.

    Dated: June 22, 2017.
E.E. Williams,
Commander, U.S. Coast Guard, Captain of the Port.
[FR Doc. 2017-13563 Filed 6-30-17; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register: July 17, 2007 (Volume 72, Number 136)]
[Notices]
[Page 39118-39121]
[DOCID:fr17jy07-86]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-56042; File No. SR-NYSEArca-2007-45]

Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing
and Order Granting Accelerated Approval of Proposed Rule Change To
Trade Units of the United States Natural Gas Fund, LP Pursuant to
Unlisted Trading Privileges

 July 11, 2007.
    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 May 15, 2007, NYSE Arca, Inc. (the ``Exchange''), through its
wholly-owned subsidiary, NYSE Arca Equities, Inc. (``NYSE Arca
Equities''), filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I and
II below, which Items have been substantially prepared by the Exchange.
This order provides notice of the proposed rule change and approves the
proposed rule change on an accelerated basis.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange, through NYSE Arca Equities, proposes to trade
partnership units (``Units'') of the United States Natural Gas Fund, LP
(``USNG'' or ``Partnership'') pursuant to unlisted trading privileges
(``UTP''). The text of the proposed rule change is available at the
Exchange, the Commission's Public Reference Room, and http://www.nyse.com
.

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

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

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

1. Purpose
    Under NYSE Arca Equities Rule 8.300, which permits the trading of
Partnership Units either by listing or pursuant to UTP,\3\ the Exchange
proposes to trade pursuant to UTP the Units of the Partnership. Each
Unit represents ownership of a fractional undivided beneficial interest
in the net assets of USNG.\4\ The Commission has approved the listing
and trading of the Units on the American Stock Exchange LLC
(``Amex'').\5\
---------------------------------------------------------------------------

    \3\ See Securities Exchange Act Release No. 53875 (May 25,
2006), 71 FR 32164 (June 2, 2006) (SR-NYSEArca-2006-11) (approving
NYSE Arca Equities Rule 8.300 and the trading of Partnership Units
of the United States Oil Fund, LP pursuant to UTP).
    \4\ USNG is a commodity pool that issues Units that would be
purchased and sold on the Exchange.
    \5\ See Securities Exchange Act Release No. 55632 (April 13,
2007), 72 FR 19987 (April 20, 2007) (SR-Amex-2006-112) (granting
approval to list and trade the Units on Amex); Securities Exchange
Act Release No. 55372 (February 28, 2007), 72 FR 10267 (March 7,
2007) (SR-Amex-2006-112) (providing notice of Amex's proposal to
list and trade the Units) (``Amex Notice'').
---------------------------------------------------------------------------

    The net assets of USNG consist of investments in futures contracts
based on natural gas, crude oil, heating oil, gasoline, and other
petroleum-based fuels traded on the New York Mercantile Exchange
(``NYMEX''), Intercontinental Exchange (``ICE Futures''), or other U.S.
and foreign exchanges (such futures contracts collectively referred to
herein as ``Futures Contracts''). USNG may also invest in other
natural-gas-related investments such as cash-settled options on Futures
Contracts; forward contracts for natural gas; over-the-counter
instruments that are based on the price of natural gas, oil, and other
petroleum-based fuels; Futures Contracts; and indices based on the
foregoing (collectively referred to herein as ``Other Natural Gas
Related Investments,'' and together with Futures Contracts, ``Natural
Gas Interests''). A detailed discussion of the natural gas, crude oil,
heating oil, and gasoline markets; futures regulation and the
regulation of USNG; investment strategy; creations and redemptions of
baskets of Units; and calculation methodology of the net asset value
(``NAV'') for the Units, among others, can be found in the Amex
Notice.\6\
---------------------------------------------------------------------------

    \6\ See id.
---------------------------------------------------------------------------

    The Web site for Amex at http://www.amex.com, which is publicly

accessible at no charge, contains the following information: (1) The
prior business day's NAV and the reported closing price; (2) the mid-
point of the bid-ask price in relation to the NAV as of the time the
NAV is calculated (``Bid-Ask Price''); \7\ (3) calculation of the
premium or discount of such price against such NAV; (4) data in chart
form displaying the frequency distribution of discounts and premiums of
the Bid-Ask Price against the NAV, within appropriate ranges for each
of the four previous calendar quarters; (5) the prospectus and the most
recent periodic reports filed with the Commission or required by the
Commodity Futures Trading Commission; and (6) other applicable
quantitative information.
---------------------------------------------------------------------------

    \7\ The Bid-Ask Price of Units is determined using the highest
bid and lowest offer as of the time of calculation of the NAV.
---------------------------------------------------------------------------

    The NAV for USNG is calculated and disseminated daily.\8\ Amex
disseminates for USNG on a daily basis through the facilities of the
Consolidated Tape Association (CTA/CQ High Speed Lines) information
with respect to the Indicative Partnership Value (as discussed below),
recent NAV, Units outstanding, the Basket Amount,\9\ and

the Deposit Amount.\10\ Amex also makes available on its Web site daily
Unit trading volume and closing prices.
---------------------------------------------------------------------------

    \8\ See Amex Notice, 72 FR at 10273 n.18 (confirming that a
representation would be obtained from USNG that its NAV per Unit
will be calculated daily and made available to all market
participants at the same time).
    \9\ A ``Basket Amount'' is the amount equal to the NAV per Unit,
times 100,000 Units (each such aggregation of Units, a ``Basket'')
calculated for the purpose of issuing Baskets to Authorized
Purchasers. See Amex Notice, 72 FR at 10271. An ``Authorized
Purchaser'' is a person, who, at the time of submitting an order to
create or redeem Units, is (1) A registered broker-dealer or other
market participant, such as a bank or other financial institution,
that is exempt from broker-dealer registration, (2) a Depository
Trust Company participant, and (3) a party to a valid Authorized
Purchaser agreement. See id.
    \10\ The ``Deposit Amount'' is the amount transferred from a
purchaser to the Administrator for the purpose of purchasing a
Basket of Units. See Amex Notice, 72 FR at 10272. The
``Administrator'' is Brown Brothers Harriman & Co., performing or
supervising the performance of services necessary for the operation
and administration of USNG. See Amex Notice, 72 FR at 10269.
---------------------------------------------------------------------------

    To provide updated information relating to USNG for use by
investors, professionals, and persons wishing to create or redeem the
Units, Amex disseminates through the facilities of the Consolidated
Tape Association an updated Indicative Partnership Value (``Indicative
Partnership Value''). The Indicative Partnership Value is disseminated
on a per-Unit basis at least every 15 seconds during the regular
trading hours of 9:30 a.m. to 4:15 p.m. Eastern Time (``ET''). The
Indicative Partnership Value is calculated based on the Cash \11\
required for creations and redemptions (i.e., NAV per limit x 100,000
Units) and adjusted to reflect the price changes of the Benchmark
Futures Contract.\12\
---------------------------------------------------------------------------

    \11\ ``Cash'' includes short-term obligations of the United
States, cash equivalents, and cash.
    \12\ The ``Benchmark Futures Contract,'' which is used to
measure changes in percentage terms of a Unit's NAV, is the natural
gas futures contract traded on NYMEX reflecting the price and change
in price of natural gas delivered at the Henry Hub, Louisiana.
---------------------------------------------------------------------------

    The Indicative Partnership Value does not reflect price changes to
the price of the Benchmark Futures Contract between the close of open-
outcry trading of such contract on NYMEX at 2:30 p.m. ET and the open
of trading on the NYMEX ACCESS market at 3:15 p.m. ET.\13\ The
Indicative Partnership Value after 3:15 p.m. ET will reflect changes to
the Benchmark Futures Contract as provided for through NYMEX ACCESS.
The value of a Unit may accordingly be influenced by non-concurrent
trading hours between the NYSE Arca Marketplace and NYMEX. While the
Units will trade on the NYSE Arca Marketplace in accordance with NYSE
Arca Equities Rule 7.34 (4 a.m. to 8 p.m. ET), the Benchmark Futures
Contract will trade, in open-outcry, on NYMEX from 10 a.m. to 2:30 pm
ET and NYMEX ACCESS from 3:15 p.m. through the following morning 9:30
a.m. ET.
---------------------------------------------------------------------------

    \13\ NYMEX ACCESS[supreg], an electronic trading system, is open
for price discovery on the Benchmark Futures Contract each Monday
through Thursday at 3:15 p.m. ET through the following morning at
9:30 a.m. ET, and from 7 p.m. Sunday night until Monday morning 9:30
a.m. ET.
---------------------------------------------------------------------------

    While NYMEX is open for trading, the Indicative Partnership Value
can be expected to closely approximate the value per Unit of the Basket
Amount. However, during trading hours when the Futures Contracts have
ceased trading, spreads and resulting premiums or discounts may widen,
and therefore, increase the difference between the price of the Units
and the NAV of the Units. The Indicative Partnership Value on a per-
Unit basis disseminated from 9:30 a.m. to 4:15 p.m. ET should not be
viewed as a real-time update of the NAV, which is calculated only once
a day.
    The Exchange represents that it will cease trading the Units of
USNG if: (1) The original listing market stops trading the Units; or
(b) the original listing market delists the Units. Additionally, the
Exchange may cease trading the Units if such other event shall occur or
condition exists which, in the opinion of the Exchange, makes further
dealings on the Exchange inadvisable.\14\ UTP trading in the Units is
also governed by the trading halts provisions of NYSE Arca Equities
Rule 7.34 relating to temporary interruptions in the calculation or
wide dissemination of the Indicative Partnership Value or the value of
the Benchmark Futures Contract.\15\
---------------------------------------------------------------------------

    \14\ With respect to trading halts, the Exchange may consider
all relevant factors in exercising its discretion to halt or suspend
trading in the Units. 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 the Units could be halted pursuant to the Exchange's
``circuit breaker'' rule or by the halt or suspension of trading of
the underlying securities. See NYSE Arca Equities Rule 7.12 (Trading
Halts Due to Extraordinary Market Volatility).
    \15\ The Exchange states that NYSE Arca Equities Rule 7.34(a)
literally addresses temporary interruptions in the calculation or
wide dissemination of the Indicative Intra-Day Value and the value
of an underlying index. The Units, however, do not have an
underlying index, but have an underlying Benchmark Futures Contract.
Therefore, the Exchange represents that the provisions in NYSE Arca
Equities Rule 7.34(a) that address interruptions in the calculation
or wide dissemination of the value of an underlying index shall also
apply, in this case, to interruptions in the calculation or wide
dissemination of the value of the underlying Benchmark Futures
Contract. See infra
---------------------------------------------------------------------------

    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. ET until 8 p.m. ET in accordance with
NYSE Arca Equities Rule 7.34 (Opening, Core, and Late Trading
Sessions). The Exchange states that it has appropriate rules to
facilitate transactions in the Units during all trading sessions.
    The Exchange intends to utilize its existing surveillance
procedures applicable to derivative products 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. The Exchange may
also obtain information via the Intermarket Surveillance Group
(``ISG'') from other exchanges who are members or affiliate members of
ISG. In addition, the Exchange has information sharing agreements in
place with NYMEX and ICE Futures for the purpose of providing
information in connection with trading in or related to futures
contracts traded on NYMEX and ICE Futures, respectively. To the extent
that USNG invests in Natural Gas Interests traded on other exchanges,
the Exchange will seek to enter into information sharing agreements
with those particular exchanges. In addition, the Exchange also has a
general policy prohibiting the distribution of material, non-public
information by its employees.
    Prior to the commencement of trading, the Exchange will inform its
ETP Holders \16\ 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; \17\ (2) the procedures for
purchases and redemptions of Units in Baskets (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 and when information regarding the Indicative Partnership Value
and NAV 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) other
relevant

trading information. In addition, the Bulletin will reference that the
Partnership is subject to various fees and expenses and that there is
no regulated source of last-sale information regarding physical
commodities. The Bulletin will also discuss any exemptive, no-action,
and/or interpretive relief granted by the Commission from any rules
under the Act.
---------------------------------------------------------------------------

    \16\ 16 An ETP Holder is a registered broker or dealer that has
been issued an Equity Trading Permit (ETP) by NYSE Arca Equities.
    \17\ E-mail from Timothy J. Malinowski, Director, NYSE Group,
Inc., to Edward Cho, Special Counsel, Division of Market Regulation,
Commission, dated July 9, 2007 (confirming that such risks will be
disclosed in the Bulletin).
---------------------------------------------------------------------------

2. Statutory Basis
    The proposal is consistent with Section 6(b) of the Act,\18\ in
general, and Section 6(b)(5) of the Act,\19\ 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.
In addition, the proposal is consistent with Rule 12f-5 under the Act
\20\ because 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.
---------------------------------------------------------------------------

    \18\ 15 U.S.C. 78f(b).
    \19\ 15 U.S.C. 78f(b)(5).
    \20\ 17 CFR 240.12f-5.
---------------------------------------------------------------------------

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

    The Exchange does not believe that the proposed rule change will
result in any burden on competition that is not necessary or
appropriate in furtherance of the purpose of the Act.

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

    The Exchange has neither solicited nor received written comments on
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-2007-45 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NYSEArca-2007-45. 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 such filing also will be available for
inspection and copying at the principal offices 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-2007-45 and should
be submitted on or before August 7, 2007.

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

    After careful review, 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.\21\ In particular, the Commission finds that the proposed
rule change is consistent with Section 6(b)(5) of the Act,\22\ which
requires that an exchange have rules designed, among other things, 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 believes that this proposal should benefit
investors by increasing competition among markets that trade the Units.
---------------------------------------------------------------------------

    \21\ 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).
    \22\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    In addition, the Commission finds that the proposal is consistent
with Section 12(f) of the Act,\23\ which permits an exchange to trade,
pursuant to UTP, a security that is listed and registered on another
exchange.\24\ The Commission notes that it previously approved the
original listing and trading of the Units on Amex.\25\ The Commission
finds that the proposal is consistent with Rule 12f-5 under the
Act,\26\ which provides that an exchange shall not extend UTP to a
security unless the exchange has in effect a rule or rules providing
for transactions in the class or type of security to which the exchange
extends UTP. The Exchange has represented that it meets this
requirement because it 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. The Commission notes that
it previously approved for trading on the Exchange pursuant to UTP
Partnership Units issued by the United States Oil Fund, LP, which are
similar to the Units issued by USNG.\27\
---------------------------------------------------------------------------

    \23\ 15 U.S.C. 78l(f).
    \24\ Section 12(a) of the Act, 15 U.S.C. 78l(a), generally
prohibits a broker-dealer from trading a security on a national
securities exchange unless the security is registered on that
exchange pursuant to Section 12 of the Act. Section 12(f) of the Act
excludes from this restriction trading in any security to which an
exchange ``extends UTP.'' When an exchange extends UTP to a
security, it allows its members to trade the security as if it were
listed and registered on the exchange even though it is not so
listed and registered.
    \25\ See supra note 5.
    \26\ 17 CFR 240.12f-5.
    \27\ See supra note 3.
---------------------------------------------------------------------------

    The Commission further believes that the proposal is consistent
with Section 11A(a)(1)(C)(iii) of the Act,\28\ 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. Quotations for and last-sale information regarding the
Units will be disseminated through the Consolidated Quotation System
and the Consolidated Tape Association,

respectively.\29\ In addition, Amex disseminates a variety of
information through the facilities of the Consolidated Tape Association
including the Indicative Partnership Value on a per-Unit basis at least
every 15 seconds during regular Amex trading hours, the number of Units
outstanding, the Basket Amount, and the Deposit Amount. Daily closing
and settlement prices for the NYMEX-traded Futures Contracts held by
USNG, delayed futures information on current and past trading sessions,
and market news are publicly available on the NYMEX Web site.
Quotations and last-sale information for the Futures Contracts are
widely disseminated through a variety of market data vendors worldwide,
including Bloomberg and Reuters. Amex's Web site contains information
related to the NAV, including the Bid-Ask Price, calculation
information and other data of the premium or discount of the Bid-Ask
Price against the NAV, the prospectus and other periodically-filed
reports, trading volume data, Unit closing prices, and other applicable
quantitative information. Finally, USNG's Web site discloses on each
business day that Amex is open for trading the total portfolio
composition of USNG, including the name, value, type, and
characteristics of the Natural Gas Interests and Cash held.
---------------------------------------------------------------------------

    \28\ 15 U.S.C. 78k-1(a)(1)(C)(iii).
    \29\ E-mail from Timothy J. Malinowski, Director, NYSE Group,
Inc., to Edward Cho, Special Counsel, Division of Market Regulation,
Commission, dated July 9, 2007 (confirming the method of
dissemination of quotations and last-sale information regarding the
Units).
---------------------------------------------------------------------------

    The Commission also believes that the Exchange's trading halt rules
are reasonably designed to prevent trading in the Shares when
transparency is impaired. Existing NYSE Arca Equities Rule 7.34(a)(4),
which will apply to the trading of the Units, provides that, if the
Benchmark Futures Contract or Indicative Partnership Value is no longer
calculated or disseminated as required (a) during the Opening Session
(4 a.m. to 9:30 a.m. ET), the Exchange may continue to trade the Units
for the remainder of the Opening Session; (b) during the Core Trading
Session (9:30 a.m. to 4 p.m. ET), the Exchange must halt trading in the
Units; and (c) during the Late Trading Session (4 p.m. to 8 p.m. ET),
the Exchange may continue trading in the Units only if the original
listing market traded such Units until the close of its regular trading
session without halt.\30\ If the Benchmark Futures Contract or
Indicative Partnership Value continues not to be calculated or
disseminated as of the next business day's Opening Session, the
Exchange will not commence trading in the Units in such Opening
Session.\31\
---------------------------------------------------------------------------

    \30\ See supra note 15 and accompanying text.
    \31\ The Exchange may resume trading in the Units only if the
calculation and dissemination of the Benchmark Futures Contract or
Indicative Partnership Value resumes, or trading in the Units
resumes in the original listing market. See NYSE Arca Equities Rule
7.34(a)(4)(C)(2).
---------------------------------------------------------------------------

    The Commission notes that, if the Units should be delisted by the
listing exchange, the Exchange would no longer have authority to trade
the Units pursuant to this order.
    In support of this proposal, the Exchange has made the following
representations:
    (1) The Exchange's surveillance procedures are adequate to address
any concerns associated with the trading of the Units on a UTP basis.
    (2) The Exchange would inform its members in an Information
Bulletin of the special characteristics and risks associated with
trading the Units, including risks inherent with trading the Units
during the Opening and Late Trading Sessions when the updated
Indicative Partnership Value is not calculated and disseminated and
suitability recommendation requirements.
    (3) The Exchange would require its members to deliver a prospectus
or product description to investors purchasing Units prior to or
concurrently with a transaction in such Units and will note this
prospectus delivery requirement in the Information Bulletin.

This approval order is conditioned on the Exchange's adherence to these
representations.
    The Commission finds good cause for approving this proposal before
the thirtieth day after the publication of notice thereof in the
Federal Register. As noted above, the Commission previously approved
the original listing and trading of the Units on Amex and the trading
of Partnership Units issued by the United States Oil Fund, LP, which
are similar to the Partnership Units issued by the Partnership,
pursuant to UTP on the Exchange. The Commission presently is not aware
of any regulatory issue that should cause it to revisit those findings
or would preclude the trading of the Units on the Exchange pursuant to
UTP. Accelerating approval of this proposal should benefit investors by
creating, without undue delay, additional competition in the market for
such Units.

V. Conclusion

    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\32\ that the proposed rule change (SR-NYSEArca-2007-45) be, and it
hereby is, approved on an accelerated basis.
---------------------------------------------------------------------------

    \32\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\33\
---------------------------------------------------------------------------

    \33\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Florence E. Harmon,
Deputy Secretary.
 [FR Doc. E7-13750 Filed 7-16-07; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 82, Number 144 (Friday, July 28, 2017)]
[Rules and Regulations]
[Pages 35067-35069]
[FR Doc No: 2017-15894]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 876

[Docket No. FDA-2017-N-1609]

Medical Devices; Gastroenterology-Urology Devices; Classification
of the Oral Removable Palatal Space Occupying Device for Weight
Management and/or Weight Loss

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is
classifying the oral removable palatal space occupying device for
weight management and/or weight loss into class II (special controls).
The special controls that will apply to the device are identified in
this order and will be part of the codified language for the oral
removable palatal space occupying device for weight management and/or
weight loss classification. The Agency is classifying the device into
class II (special controls) in order to provide a reasonable assurance
of safety and effectiveness of the device.

DATES: This order is effective July 28, 2017. The classification was
applicable on September 26, 2016.

FOR FURTHER INFORMATION CONTACT: Mark Antonino, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. G208, Silver Spring, MD, 20993-0002,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    In accordance with section 513(f)(1) of the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) (21 U.S.C. 360c(f)(1)), devices that were
not in commercial distribution before May 28, 1976 (the date of
enactment of the Medical Device Amendments of 1976), generally referred
to as postamendments devices, are classified automatically by statute
into class III without any FDA rulemaking process. These devices remain
in class III and require premarket approval, unless and until the
device is classified or reclassified into class I or II, or FDA issues
an order finding the device to be substantially equivalent, in
accordance with section 513(i) of the FD&C Act, to a predicate device
that does not require premarket approval. The Agency determines whether
new devices are substantially

equivalent to predicate devices by means of premarket notification
procedures in section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and
part 807 (21 CFR part 807) of the regulations.
    Section 513(f)(2) of the FD&C Act, also known as De Novo
classification, as amended by section 607 of the Food and Drug
Administration Safety and Innovation Act (Pub. L. 112-144), provides
two procedures by which a person may request FDA to classify a device
under the criteria set forth in section 513(a)(1) of the FD&C Act.
Under the first procedure, the person submits a premarket notification
under section 510(k) of the FD&C Act for a device that has not
previously been classified and, within 30 days of receiving an order
classifying the device into class III under section 513(f)(1), the
person requests a classification under section 513(f)(2) of the FD&C
Act. Under the second procedure, rather than first submitting a
premarket notification under section 510(k) of the FD&C Act and then a
request for classification under the first procedure, the person
determines that there is no legally marketed device upon which to base
a determination of substantial equivalence and requests a
classification under section 513(f)(2) of the FD&C Act. If the person
submits a request to classify the device under this second procedure,
FDA may decline to undertake the classification request if FDA
identifies a legally marketed device that could provide a reasonable
basis for review of substantial equivalence with the device or if FDA
determines that the device submitted is not of ``low-moderate risk'' or
that general controls would be inadequate to control the risks and
special controls to mitigate the risks cannot be developed.
    In response to a request to classify a device under either
procedure provided by section 513(f)(2) of the FD&C Act, FDA shall
classify the device by written order within 120 days. This
classification will be the initial classification of the device.
    On July 31, 2015, Scientific Intake submitted a request for
classification of the Sensor Monitored Alimentary Restriction Therapy
(SMART) device under section 513(f)(2) of the FD&C Act.
    In accordance with section 513(f)(2) of the FD&C Act, FDA reviewed
the request in order to classify the device under the criteria for
classification set forth in section 513(a)(1). FDA classifies devices
into class II if general controls by themselves are insufficient to
provide reasonable assurance of safety and effectiveness, but there is
sufficient information to establish special controls to provide
reasonable assurance of the safety and effectiveness of the device for
its intended use. After review of the information submitted in the
request, FDA determined that the device can be classified into class II
with the establishment of special controls. FDA believes these special
controls, in addition to general controls, will provide reasonable
assurance of the safety and effectiveness of the device.
    Therefore, on September 26, 2016, FDA issued an order to the
requestor classifying the device into class II. FDA is codifying the
classification of the device by adding 21 CFR 876.5981.
    Following the effective date of this final classification order,
any firm submitting a premarket notification (510(k)) for an oral
removable palatal space occupying device for weight management and/or
weight loss will need to comply with the special controls named in this
final order. A De Novo classification decreases regulatory burdens.
When FDA classifies a device type as class I or II via the De Novo
pathway, other manufacturers do not have to submit a De Novo request or
premarket approval application to market the same type of device,
unless the device has a new intended use or technological
characteristics that raise different questions of safety or
effectiveness. Instead, manufacturers can use the less burdensome
510(k) pathway, when necessary, to market their device, and the device
that was the subject of the original De Novo classification can serve
as a predicate device for additional 510(k)s from other manufacturers.
    The device is assigned the generic name oral removable palatal
space occupying device for weight management and/or weight loss, and it
is identified as a prescription device that is worn during meals to
limit bite size, thereby reducing the amount of food that is consumed.
The device may contain recording sensors for monitoring patient use.
This classification does not include devices that are intended to treat
any dental diseases or conditions.
    FDA has identified the following risks to health associated
specifically with this type of device and the measures required to
mitigate these risks in Table 1.

    Table 1--Oral Removable Palatal Space Occupying Device for Weight
  Management and/or Weight Loss Risks to Health and Mitigation Measures
------------------------------------------------------------------------
       Identified risks                   Mitigation measures
------------------------------------------------------------------------
Tooth Movement, Irritation,    Non-clinical performance testing.
 and Soreness of Mouth or      Labeling.
 Gums, including:              Training.
 Improper mold
 making;
 User error; and
 Damage to material
 (soft edge separation)
Choking or gag reflex........  Clinical performance testing.
                               Labeling.
Adverse tissue reaction......  Biocompatibility evaluation.
Incorrect data                 Non-clinical performance testing.
 interpretation, including:    Labeling.
 Hardware malfunction  Training.
 (sensor malfunction)
Electrical shock and           Non-clinical performance testing.
 electrical interference with
 other devices.
Weight gain..................  Clinical performance testing.
                               Labeling.
------------------------------------------------------------------------

    FDA believes that the special controls, in combination with the
general controls, address these risks to health and provide reasonable
assurance of safety and effectiveness.
    Oral removable palatal space occupying devices for weight
management and/or weight loss are not safe for use except under the
supervision of a practitioner licensed by law to direct the use of the
device. As such, the device is a prescription device and must satisfy
prescription labeling requirements (see 21 CFR 801.109, Prescription
devices).

    Section 510(m) of the FD&C Act provides that FDA may exempt a class
II device from the premarket notification requirements under section
510(k), if FDA determines that premarket notification is not necessary
to provide reasonable assurance of the safety and effectiveness of the
device. For this type of device, FDA believes premarket notification is
not necessary to provide reasonable assurance of the safety and
effectiveness of the device type and, therefore, is planning to exempt
the device from the premarket notification requirements under section
510(m) of the FD&C Act. Once finalized, persons who intend to market
this device type need not submit a 510(k) premarket notification
containing information on the oral removable palatal space occupying
device for weight management and/or weight loss prior to marketing the
device.

II. Analysis of Environmental Impact

    The Agency has determined under 21 CFR 25.34(b) that this action is
of a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.

III. Paperwork Reduction Act of 1995

    This final order establishes special controls that refer to
previously approved collections of information found in other 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). The collections of information in
part 807, subpart E, regarding premarket notification submissions have
been approved under OMB control number 0910-0120, and the collections
of information in 21 CFR part 801 regarding labeling have been approved
under OMB control number 0910-0485.

List of Subjects in 21 CFR Part 876

    Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
876 is amended as follows:

PART 876--GASTROENTEROLOGY-UROLOGY DEVICES

0
1. The authority citation for part 876 continues to read as follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

0
2. Add Sec.  876.5981 to subpart F to read as follows:

Sec.  876.5981  Oral removable palatal space occupying device for
weight management and/or weight loss.

    (a) Identification. An oral removable palatal space occupying
device for weight management and/or weight loss is a prescription
device that is worn during meals to limit bite size, thereby reducing
the amount of food that is consumed. The device may contain recording
sensors for monitoring patient use. This classification does not
include devices that are intended to treat any dental diseases or
conditions
    (b) Classification. Class II (special controls). The special
controls for this device are:
    (1) The patient-contacting components of the device must be
demonstrated to be biocompatible for its intended use.
    (2) Non-clinical performance testing must demonstrate that the
device performs as intended under anticipated conditions for use, as
follows:
    (i) Mechanical testing must demonstrate that the device performs as
intended for the labeled use life and does not create forces that
result in movement of teeth and damage to teeth.
    (ii) Electrical safety and electromagnetic compatibility testing
must demonstrate that the device performs as intended.
    (iii) Software verification and validation must demonstrate that
the device performs as intended.
    (iv) Battery testing must demonstrate that the device battery
performs as intended.
    (3) Clinical performance testing must demonstrate the device
performs as intended and must include an evaluation for choking.
    (4) Device labeling must address the following:
    (i) Patient labeling must state:
    (A) The clinical benefit of weight management and/or weight loss as
assessed by using percent total body weight loss;
    (B) Treatment must be offered in combination with a behavioral
modification program;
    (C) Instructions on how to use the device as intended; and
    (D) The use life of the device.
    (ii) Physician labeling must state:
    (A) The clinical benefit of weight management and/or weight loss as
assessed by using percent total body weight loss;
    (B) Treatment must be offered in combination with a behavioral
modification program;
    (C) Instructions on how to use the device as intended; and
    (D) The use life of the device.
    (5) Training must be provided to health professionals that includes
procedures for determining a patient's oral health status, instructions
for making the palatal mold, and assessment of issues with the device
that may require service by the manufacturer.

    Dated: July 24, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-15894 Filed 7-27-17; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 77, Number 198 (Friday, October 12, 2012)]
[Notices]
[Pages 62300-62302]
[FR Doc No: 2012-25086]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-68000; File No. SR-ISE-2012-81]

Self-Regulatory Organizations; International Securities Exchange,
LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule
Change To Adopt a Pilot Program To Eliminate Position and Exercise
Limits in SPY Options

October 5, 2012.
    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 September 27, 2012, the International Securities Exchange, LLC (the
``Exchange'' or the ``ISE'') 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.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to amend its rules to eliminate position and
exercise limits for physically-settled options on the SPDR S&P ETF
Trust (``SPY'') pursuant to a pilot program. The text of the proposed
rule change is available on the Exchange's Web site www.ise.com, at the
principal office of the Exchange, and at the Commission's Public
Reference Room.

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

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

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

1. Purpose
    ISE proposes to amend Supplementary Material .01 to ISE Rule 412
and Supplementary Material .01 of ISE Rule 414 to eliminate position
and exercise limits, respectively, for physically-settled SPY options
pursuant to a pilot program. This filing is based on a filing
previously submitted by NYSE MKT LLC (f/k/a NYSE Amex, LLC (``NYSE
Amex'')), which the Commission recently approved.\3\
---------------------------------------------------------------------------

    \3\ See Securities Exchange Act Release No. 67672 (August 15,
2012), 77 FR 50750 (August 22, 2012) (SR-NYSEAmex-2012-29).
---------------------------------------------------------------------------

    The Exchange began trading SPY options on January 10, 2005. That
year, the position limit for these options was increased from 75,000
contracts to 300,000 contracts on the same side of the market.\4\ In
July 2011, the position limit for these options was again increased
from 300,000 contracts to the

current limit of 900,000 contracts on the same side of the market.\5\
---------------------------------------------------------------------------

    \4\ See Securities Exchange Act Release No. 51042 (January 14,
2005), 70 FR 3412 (January 24, 2005) (SR-ISE-2005-05).
    \5\ See Securities Exchange Act Release No. 64760 (June 28,
2011), 76 FR 39143 (July 5, 2011) (SR-ISE-2011-34).
---------------------------------------------------------------------------

    The underlying SPY generally tracks the performance of the S&P 500
Index and the Exchange states that the SPY and SPY options have deep,
liquid markets that reduce concerns regarding manipulation and
disruption in the underlying markets. In support of this proposed rule
change, the Exchange has collected the following trading statistics for
SPY and SPY options: (1) The average daily volume (``ADV'') to date (as
of August 24, 2012) for SPY is 148 million shares; (2) the ADV to date
in 2012 for SPY options is 2.6 million; (3) the total shares
outstanding for SPY are 750.3 million; and (4) the fund market cap for
SPY is $106 billion. The Exchange represents further that there is
tremendous liquidity in the securities that make up the S&P 500 Index.
For example, the ADV of the component securities in the S&P 500 Index
for the 6-month period of February 28, 2012 through August 28, 2012 was
635,583,189.
    Under the Exchange's proposal, the options reporting requirement
for SPY options would continue unabated. Thus, the Exchange would still
require that each Member that maintains a position in SPY options on
the same side of the market, for its own account or for the account of
a customer, report certain information to the Exchange. This
information would include, but would not be limited to, the option
position, whether such position is hedged and, if so, a description of
the hedge, and the collateral used to carry the position, if
applicable. Exchange market makers would continue to be exempt from
this reporting requirement, as market maker information can be accessed
through the Exchange's market surveillance systems. In addition, the
general reporting requirement for customer accounts that maintain an
aggregate position of 200 or more option contracts would remain at this
level for SPY options.\6\
---------------------------------------------------------------------------

    \6\ See ISE Rule 415(a).
---------------------------------------------------------------------------

    In addition, ISE Rule 4.15(b) [sic] provides:

    Electronic Access Members that maintain an end of day position
in excess of 10,000 non-FLEX equity options contracts on the same
side of the market on behalf of its own account or for the account
of a customer, shall report whether such position is hedged and
provide documentation as to how such position is hedged. This report
is required at the time the subject account exceeds the 10,000
contract threshold and thereafter, for customer accounts, when the
position increases by 2,500 contracts and for proprietary accounts
when the position increases by 5,000 contracts.

    As the anniversary of listed options trading approaches its
fortieth year, the Exchange believes that the existing surveillance
procedures and reporting requirements at ISE, other options exchanges,
and at the several clearing firms are capable of properly identifying
unusual and/or illegal trading activity. In addition, routine oversight
inspections of the Exchange's regulatory programs by the Commission
have not uncovered any material inconsistencies or shortcomings in the
manner in which the Exchange's market surveillance is conducted. These
procedures utilize daily monitoring of market movements via automated
surveillance techniques to identify unusual activity in both options
and underlying stocks.\7\
---------------------------------------------------------------------------

    \7\ These procedures have been effective for the surveillance of
SPY options trading and will continue to be employed.
---------------------------------------------------------------------------

    Furthermore, large stock holdings must be disclosed to the
Commission by way of Schedules 13D or 13G.\8\ Options positions are
part of any reportable positions and, thus, cannot be legally hidden.
Moreover, the Exchange's requirement that Members file reports with the
Exchange for any customer who held aggregate large long or short
positions of any single class for the previous day will continue to
serve as an important part of the Exchange's surveillance efforts.
---------------------------------------------------------------------------

    \8\ 17 CFR 240.13d-1.
---------------------------------------------------------------------------

    The Exchange believes that the current financial requirements
imposed by the Exchange and by the Commission adequately address
concerns that a Member or its customer may try to maintain an
inordinately large un-hedged position in an option, particularly on
SPY. Current margin and risk-based haircut methodologies serve to limit
the size of positions maintained by any one account by increasing the
margin and/or capital that a Member must maintain for a large position
held by itself or by its customer. In addition, the Commission's net
capital rule, Rule 15c3-1 \9\ under the Securities Exchange Act of 1934
(the ``Act''),\10\ imposes a capital charge on members to the extent of
any margin deficiency resulting from the higher margin requirement.
---------------------------------------------------------------------------

    \9\ 17 CFR 240.15c3-1.
    \10\ 15 U.S.C. 78s(b)(1).
---------------------------------------------------------------------------

Pilot Program
    The Exchange proposes that this rule change be adopted pursuant to
a pilot program, set to expire December 5, 2013.\11\ The Exchange will
perform an analysis of the initial pilot program to eliminate position
limits in SPY after the first twelve (12) months of the pilot program
(the ``Pilot Report''). The Pilot Report will be submitted within
thirty (30) days of the end of such twelve (12) month time period. The
Pilot Report will detail the size and different types of strategies
employed with respect to positions established as a result of the
elimination of position limits in SPY. In addition, the report will
note whether any problems resulted due to the no limit approach and any
other information that may be useful in evaluating the effectiveness of
the pilot program. The Pilot Report will compare the impact of the
pilot program, if any, on the volumes of SPY options and the volatility
in the price of the underlying SPY shares, particularly at expiration.
In preparing the report the Exchange will utilize various data elements
such as volume and open interest. In addition the Exchange will make
available to Commission staff data elements relating to the
effectiveness of the pilot program.
---------------------------------------------------------------------------

    \11\ The Exchange will notify ISE Members of the establishment
of the pilot program and the running dates of the pilot program via
regulatory circular.
---------------------------------------------------------------------------

    Conditional on the findings in the Pilot Report, ISE will file with
the Commission a proposal to either extend the pilot program, adopt the
pilot program on a permanent basis, or terminate the pilot program. If
the pilot program is not extended or adopted on a permanent basis by
December 5, 2013, the position limits for SPY would revert to limits in
effect at the commencement of the pilot program.
    The Exchange believes that the elimination of position and exercise
limits on SPY options on a pilot basis is required for competitive
purposes as well as for purposes of consistency and uniformity among
the competing options exchanges. This supports the Exchange's current
proposal to eliminate the position and exercise limits applicable to
physically-settled SPY options on a pilot basis.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with the Securities Exchange Act of 1934 \12\ (the ``Act'') in general,
and furthers the objectives of Section 6(b)(5) of the Act \13\ in
particular, in that it is designed to prevent fraudulent and
manipulative acts and practices, to promote just and equitable
principles of trade, to foster cooperation and coordination with
persons engaged in facilitating transactions in securities, to remove
impediments to and perfect the mechanism of a free and open market and
a national market system, and, in

general to protect investors and the public interest.
---------------------------------------------------------------------------

    \12\ 15 U.S.C. 78f(b).
    \13\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    Specifically, the proposed rule change will benefit large market
makers (which generally have the greatest potential and actual
liability [sic] to provide liquidity and depth I [sic] the product), as
well as retail traders, investors, and public customers, by providing
them with a more effective trading and hedging vehicle. In addition,
the Exchange believes that the structure of SPY options and the
considerable liquidity of the market for SPY options diminish the
opportunity to manipulate this product and disrupt the underlying
market that a lower position limit may protect against. The Exchange
also believes that the proposed rule change will benefit a greater
number of market participants who are ISE Members and members of other
exchanges. This is because SPY is a multiply listed options class and
currently there is not a uniform and consistent position and exercise
limits regime across all of the exchanges that list SPY options. The
proposed filing will benefit market participants because it will ensure
consistency and uniformity among the competing options exchanges as to
the position and exercise limits for a multiply listed options class.

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

    ISE does not believe that this proposed rule change will impose any
burden on competition that is not necessary or appropriate in
furtherance of the purposes of the Exchange Act. In this regard and as
indicated above, the Exchange notes that the rule change is being
proposed as a competitive response to a NYSE Amex filing. ISE believes
this proposed rule change is necessary to permit fair competition among
the options exchanges and to establish uniform positions for a multiply
listed options class.

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

    The Exchange has not solicited, and does not intend to solicit,
comments on this proposed rule change. The Exchange has not received
any unsolicited written comments from members or other interested
parties.

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

    Because the proposed rule change does not: (i) Significantly affect
the protection of investors or the public interest; (ii) impose any
significant burden on competition; and (iii) become operative prior to
30 days from the date on which it was filed, or such shorter time as
the Commission may designate, the proposed rule change has become
effective pursuant to Section 19(b)(3)(A) of the Act \14\ and Rule 19b-
4(f)(6) thereunder.\15\
---------------------------------------------------------------------------

    \14\ 15 U.S.C. 78s(b)(3)(A).
    \15\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)
requires a self-regulatory organization to give the Commission
written notice of its intent to file the proposed rule change at
least five business days prior to the date of filing of the proposed
rule change, or such shorter time as designated by the Commission.
The Exchange has satisfied this requirement.
---------------------------------------------------------------------------

    A proposed rule change filed pursuant to Rule 19b-4(f)(6) under the
Act \16\ normally does not become operative for 30 days after the date
of its filing. However, Rule 19b-4(f)(6) \17\ permits the Commission to
designate a shorter time if such action is consistent with the
protection of investors and the public interest. The Exchange has asked
the Commission to waive the 30-day operative delay, noting that doing
so will ensure fair competition among options exchanges and immediately
benefit market participants who are ISE members and members of other
exchanges by ensuring consistency and uniformity across options
exchanges with respect to the multiply listed SPY options class. The
Commission believes that waiving the 30-day operative delay is
consistent with the protection of investors and the public
interest.\18\ Therefore, the Commission hereby waives the 30-day
operative delay and designates the proposal operative as of October 5,
2012.
---------------------------------------------------------------------------

    \16\ 17 CFR 240.19b-4(f)(6).
    \17\ 17 CFR 240.19b-4(f)(6).
    \18\ For purposes only of waiving the 30-day operative delay,
the Commission has considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
---------------------------------------------------------------------------

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

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-ISE-2012-81 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-ISE-2012-81. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549, on official business days between the hours of
10:00 a.m. and 3:00 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-ISE-2012-81 and
should be submitted on or before November 2, 2012.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\19\
---------------------------------------------------------------------------

    \19\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2012-25086 Filed 10-11-12; 8:45 am]
BILLING CODE 8011-01-P