[Federal Register Volume 78, Number 32 (Friday, February 15, 2013)]
[Notices]
[Pages 11208-11209]
[FR Doc No: 2013-03488]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0001]

Circulatory System Devices Panel of the Medical Devices Advisory
Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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    This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will
be open to the public.
    Name of Committee: Circulatory System Devices Panel of the Medical
Devices Advisory Committee.
    General Function of the Committee: To provide advice and
recommendations to the Agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on March 20, 2013, from 8
a.m. to 6 p.m.
    Location: Holiday Inn, Ballroom, Two Montgomery Village Ave.,
Gaithersburg, MD 20879. The hotel's phone number is<PHONE_NUMBER>.
    Contact Person: Jamie Waterhouse, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993, or FDA Advisory Committee Information
Line, 1-800-741-8138<PHONE_NUMBER> in the Washington, DC area). A
notice in the Federal Register about last minute modifications that
impact a previously announced advisory committee meeting cannot always
be published quickly enough to provide timely notice. Therefore, you
should always check the Agency's Web site at http://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate
advisory committee meeting link, or call the advisory committee
information line to learn about possible modifications before coming to
the meeting.
    Agenda: On March 20, 2013, the committee will discuss, make
recommendations, and vote on information related to the premarket
approval application for the MitraClip Delivery System sponsored by
Abbott Vascular. The system consists of three major components: The
delivery catheter, the steerable sleeve, and the MitraClip device. The
MitraClip device is a single sized, percutaneously implanted mechanical
clip for the reduction of mitral regurgitation. The MitraClip device
grasps and coapts the mitral valve leaflets resulting in fixed
approximation of the mitral leaflets throughout the cardiac cycle. The
implantable MitraClip device is fabricated with metal alloys and
polyester fabric (Clip cover) that are commonly used in cardiovascular
implants. The proposed indication for use: The MitraClip Delivery
System is indicated for the percutaneous reduction of significant
symptomatic mitral regurgitation (MR>=3) in patients who have been
determined by a cardiac surgeon to be too high risk for open mitral
valve surgery and in whom existing comorbidities would not

preclude the expected benefit from correction of the mitral
regurgitation.
    FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its Web site prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's Web site after the meeting. Background material is
available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting
link.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person on or before
March 13, 2013. Oral presentations from the public will be scheduled
between approximately 1 p.m. and 2 p.m. on March 20, 2013. Those
individuals interested in making formal oral presentations should
notify the contact person and submit a brief statement of the general
nature of the evidence or arguments they wish to present, the names and
addresses of proposed participants, and an indication of the
approximate time requested to make their presentation on or before
March 1, 2013. Time allotted for each presentation may be limited. If
the number of registrants requesting to speak is greater than can be
reasonably accommodated during the scheduled open public hearing
session, FDA may conduct a lottery to determine the speakers for the
scheduled open public hearing session. The contact person will notify
interested persons regarding their request to speak by March 4, 2013.
    Persons attending FDA's advisory committee meetings are advised
that the Agency is not responsible for providing access to electrical
outlets.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
physical disabilities or special needs. If you require special
accommodations due to a disability, please contact James Clark,
Conference Management Staff, at<EMAIL_ADDRESS>or 301-796-
5293, at least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: February 11, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-03488 Filed 2-14-13; 8:45 am]
BILLING CODE 4160-01-P


Comment Info: =================

General Comment:FAA-2010-0380; Dir. ID 2009-NM-009-AD.  See Grid


[Federal Register Volume 85, Number 109 (Friday, June 5, 2020)]
[Rules and Regulations]
[Pages 34519-34520]
[FR Doc No: 2020-11303]

=======================================================================
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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2020-0237]
RIN 1625-AA00

Safety Zone; Schwab Family Fireworks, Lake Huron, MI

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard is establishing a temporary safety zone for
navigable waters within a 200-yard radius of a portion of Lake Huron,
Harbor Beach, MI. This zone is necessary to protect spectators and
vessels from potential hazards associated with the Schwab Family
Fireworks.

DATES: This temporary final rule is effective from 10 p.m. to 11 p.m.
on July 4, 2020.

ADDRESSES: To view documents mentioned in this preamble as being
available in the docket, go to http://www.regulations.gov, type USCG-
2020-0237 in the ``SEARCH'' box and click ``SEARCH.'' Click on Open
Docket Folder on the line associated with this rule.

FOR FURTHER INFORMATION CONTACT: If you have questions on this
temporary rule, call or email Tracy Girard, Prevention Department,
Sector Detroit, Coast Guard; telephone<PHONE_NUMBER>, or email
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
COTP Captain of the Port Detroit
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of Proposed Rulemaking
Sec.  Section
U.S.C. United States Code

II. Background Information and Regulatory History

    The Coast Guard is issuing this temporary rule without prior notice
and opportunity to comment pursuant to authority under section 4(a) of
the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b) (B), the Coast Guard finds that good
cause exists for not publishing a notice of proposed rulemaking (NPRM)
with respect to this rule because doing so would be impracticable. The
Coast Guard did not receive the final details of this fireworks display
in time to publish an NPRM. As such, it is impracticable to publish an
NPRM because we lack sufficient time to provide a reasonable comment
period and then consider those comments before issuing the rule.

III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority in 46 U.S.C.
70034. The Captain of the Port Detroit (COTP) has determined that
potential hazard associated with fireworks from 10 p.m. until 11 p.m.
on July 4, 2020 will be a safety concern to anyone within a 200-yard
radius of the launch site. This rule is needed to protect personnel,
vessels, and the marine environment in the navigable waters within the
safety zone while the fireworks are being displayed.

IV. Discussion of the Rule

    This rule establishes a safety zone from 10 p.m. until 11 p.m. on
July 4, 2020. The safety zone will encompass all U.S. navigable waters
of Lake Huron, Harbor Beach, MI within a 200-yard radius of position
43[deg]53.48'N, 082[deg]40.76'W (NAD 83). No vessel or person will be
permitted to enter the safety zone without obtaining permission from
the COTP or a designated representative.

V. Regulatory Analyses

    We developed this rule after considering numerous statutes and
Executive orders related to rulemaking. Below we summarize our analyses
based on a number of these statutes and Executive orders, and we
discuss First Amendment rights of protestors.

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. Executive Order 13771 directs agencies to control
regulatory costs through a budgeting process. This rule has not been
designated a ``significant regulatory action,'' under Executive Order
12866. Accordingly, this rule has not been reviewed by the Office of
Management and Budget (OMB), and pursuant to OMB guidance it is exempt
from the requirements of Executive Order 13771.
    This regulatory action determination is based on the size,
location, duration, and time-of-year of the safety zone. Vessel traffic
will be able to safely transit around this safety zone which will
impact a small designated area of Lake Huron from 10 p.m. on July 4,
2020. Moreover, the Coast Guard will issue Broadcast Notice to Mariners
(BNM) via VHF-FM marine channel 16 about the zone and the rule allows
vessels to seek permission to enter the zone.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as
amended, requires Federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule
will not have a significant economic impact on a substantial number of
small entities.
    While some owners or operators of vessels intending to transit the
safety zone may be small entities, for the reasons stated in section
V.A above, this rule will not have a significant economic impact on any
vessel owner or operator.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Public Law 104-121), we want to assist small
entities in understanding this rule. If the rule would affect your
small business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
contact the person listed in the FOR FURTHER INFORMATION CONTACT
section.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

C. Collection of Information

    This rule will not call for a new collection of information under
the

Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

D. Federalism and Indian Tribal Governments

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government. We have analyzed this rule under that Order and have
determined that it is consistent with the fundamental federalism
principles and preemption requirements described in Executive Order
13132.
    Also, this rule does not have tribal implications under Executive
Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it does not have a substantial direct effect on
one or more Indian tribes, on the relationship between the Federal
Government and Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes. If
you believe this rule has implications for federalism or Indian tribes,
please contact the person listed in the FOR FURTHER INFORMATION CONTACT
section above.

E. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this rule will not result in
such an expenditure, we do discuss the effects of this rule elsewhere
in this preamble.

F. Environment

    We have analyzed this rule under Department of Homeland Security
Directive 023-01 and Environmental Planning COMDTINST 5090.1 (series),
which guide the Coast Guard in complying with the National
Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have
determined that this action is one of a category of actions that do not
individually or cumulatively have a significant effect on the human
environment. This rule involves a safety zone lasting one and a half
hours on two nights that will prohibit entry into a designated area. It
is categorically excluded from further review under paragraph L60(a) in
Table 3-1 of U.S. Coast Guard Environmental Planning Implementing
Procedures 5090.1. A Record of Environmental Consideration supporting
this determination is available in the docket where indicated under
ADDRESSES.

G. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to contact the person listed in the FOR FURTHER
INFORMATION CONTACT section to coordinate protest activities so that
your message can be received without jeopardizing the safety or
security of people, places or vessels.

List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and record
keeping requirements, Security measures, Waterways.

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows:

    Authority:  46 U.S.C. 70034, 70051; 33 CFR 1.05-1, 6.04-1, 6.04-
6, and 160.5; Department of Homeland Security Delegation No. 0170.1.

0
2. Add Sec.  165.T09-0237 to read as follows:

Sec.  165.T09-0237  Safety Zone; Schwab Family Fireworks, Lake Huron,
MI.

    (a) Location. A safety zone is established to include all U.S.
navigable waters of Lake Huron, Harbor Beach, MI within a 200-yard
radius of position 43[deg]53.48' N, 082[deg]40.76' W (NAD 83).
    (b) Enforcement period. The regulated area described in paragraph
(a) will be enforced from 10 p.m. until 11 p.m. on July 4, 2020.
    (c) Regulations. (1) No vessel or person may enter, transit
through, or anchor within the safety zone unless authorized by the
Captain of the Port Detroit (COTP), or his on-scene representative.
    (2) The safety zone is closed to all vessel traffic, except as may
be permitted by the COTP or his on-scene representative.
    (3) The ``on-scene representative'' of COTP is any Coast Guard
commissioned, warrant or petty officer or a Federal, State, or local
law enforcement officer designated by or assisting the Captain of the
Port Detroit to act on his behalf.
    (4) Vessel operators shall contact the COTP or his on-scene
representative to obtain permission to enter or operate within the
safety zone. The COTP or his on-scene representative may be contacted
via VHF Channel 16 or at<PHONE_NUMBER>. Vessel operators given
permission to enter or operate in the regulated area must comply with
all directions given to them by the COTP or his on-scene
representative.

    Dated: May 13, 2020.
Jeffrey W. Novak,
Captain, U.S. Coast Guard, Captain of the Port Detroit.
[FR Doc. 2020-11303 Filed 6-4-20; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register Volume 86, Number 245 (Monday, December 27, 2021)]
[Notices]
[Pages 73391-73396]
[FR Doc No: 2021-27927]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-93835; File No. SR-NYSEAMER-2021-45]

Self-Regulatory Organizations; NYSE American LLC; Notice of
Filing and Immediate Effectiveness of Proposed Rule Change to Amend
Rule 904 (Position Limits)

December 20, 2021.
    Pursuant to Section 19(b)(1) \1\ of the Securities Exchange Act of
1934 (the ``Act'') \2\ and Rule 19b-4 thereunder,\3\ notice is hereby
given that on December 6, 2021, NYSE American LLC (``NYSE American'' or
the ``Exchange'') filed with the Securities and Exchange Commission
(the ``Commission'') the proposed rule change as described in Items I
and II below, which Items have been prepared by the self-regulatory
organization. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 15 U.S.C. 78a.
    \3\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

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

    The Exchange proposes to amend Rule 904 (Position Limits) to
increase position limits for options on certain exchange-traded funds.
The proposed rule change is available on the Exchange's website at
www.nyse.com, at the principal office of the Exchange, and at the
Commission's Public Reference Room.

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

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

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

1. Purpose
    The Exchange proposes to amend Rule 904 (Position Limits) to
increase position limits for options on certain exchange-traded funds
(``ETFs''). This is a competitive filing that is based on a proposal
recently submitted by Cboe Exchange, Inc. (``Cboe'') and approved by
the Securities and Exchange Commission (``Commission'').\4\
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    \4\ See Securities Exchange Act Release No. 93525 (November 4,
2021), 86 FR 62584 (November 10, 2021) (Notice of Filing of
Amendment Nos. 2 and 3 and Order Granting Accelerated Approval of
SR-CBOE-2021-029).
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    Position limits are designed to address potential manipulative
schemes and adverse market impacts surrounding the use of options, such
as disrupting the market in the security underlying the options. While
position limits should address and discourage the potential for
manipulative schemes and adverse market impact, if such limits are set
too low, participation in the options market may be discouraged. The
Exchange believes that position limits must therefore be balanced
between mitigating concerns of any potential manipulation and the cost
of inhibiting potential hedging activity that could be used for
legitimate economic purposes.

    In its filing, Cboe states that it has observed an ongoing increase
in demand, for both trading and hedging purposes, in options on the
following ETFs: (1) iShares iBoxx $ Investment Grade Corporate Bond ETF
(``LQD'') and (2) VanEck Vectors Gold Miners ETF (``GDX''). Though the
demand for these options appears to have increased, position limits for
options on LQD and GDX have remained the same. The Exchange believes
these unchanged position limits may have impeded, and may continue to
impede, trading activity and strategies of investors, such as use of
effective hedging vehicles or income generating strategies (e.g., buy-
write or put-write), and the ability of Market Makers to make liquid
markets with tighter spreads in these options resulting in the transfer
of volume to over-the-counter (``OTC'') markets. OTC transactions occur
through bilateral agreements, the terms of which are not publicly
disclosed to the marketplace. As such, OTC transactions do not
contribute to the price discovery process on a public exchange or other
lit markets. Therefore, the Exchange believes that the proposed
increases in position limits for options on LQD and GDX may enable
liquidity providers to provide additional liquidity to the Exchange and
other market participants to transfer their liquidity demands from OTC
markets to the Exchange. As described in further detail below, the
Exchange believes that the continuously increasing market
capitalization of LQD and GDX, including ETF components, as well as the
highly liquid markets for each, reduces the concerns for potential
market manipulation and/or disruption in the underlying markets upon
increasing position limits, while the rising demand for trading options
on LQD and GDX for legitimate economic purposes compels an increase in
position limits.
Proposed Position Limits for Options on LQD and GDX
    Position limits for options on ETFs are determined pursuant to Rule
904 and vary according to the number of outstanding shares and the
trading volumes of the underlying equity security (which includes ETFs)
over the past six months. Pursuant to Rule 904, the largest in
capitalization and the most frequently traded stocks and ETFs have an
option position limit of 250,000 contracts (with adjustments for
splits, re-capitalizations, etc.) on the same side of the market; and
smaller capitalization stocks and ETFs have position limits of 200,000,
75,000, 50,000 or 25,000 contracts (with adjustments for splits, re-
capitalizations, etc.) on the same side of the market. Options on LQD
and GDX are currently subject to the standard position limit of 250,000
contracts as set forth in Rule 904. Commentary .07(f) to Rule 904 sets
forth separate, higher position limits for specific equity options
(including options on specific ETFs).\5\ The Exchange proposes to amend
Commentary .07(f) to Rule 904 to increase the position limits and, as a
result, exercise limits, for options on LQD and GDX.\6\ The table below
represents the current, and proposed, position limits for options on
the ETFs subject to this proposal:
---------------------------------------------------------------------------

    \5\ Adjusted option series, in which one option contract in the
series represents the delivery of other than 100 shares of the
underlying security as a result of a corporate action by the issuer
of the security underlying such option series, do not impact the
notional value of the underlying security represented by those
options. When an underlying security undergoes a corporate action
resulting in adjusted series, the Exchange lists new standard option
series across all appropriate expiration months the day after the
existing series are adjusted. The adjusted series are generally
actively traded for a short period of time following adjustment, but
orders to open options positions in the underlying security are
almost exclusively placed in the new standard option series
contracts.
    \6\ By virtue of Rule 905 (Exercise Limits), which is not being
amended by this filing, the exercise limits for LQD and GDX options
would be similarly increased, because Rule 905 provides that the
exercise limits for index options and ETF options, respectively, are
equivalent to their position limits.

------------------------------------------------------------------------
                                              Current        Proposal
                 Product                     position        position
                                               limit           limit
------------------------------------------------------------------------
LQD.....................................         250,000         500,000
GDX.....................................         250,000         500,000
------------------------------------------------------------------------

    The Exchange notes that the proposed position limit for options on
LQD and GDX are consistent with current position limits for options on
the iShares MSCI Brazil Capped ETF (``EWZ''), iShares 20+ Year Treasury
Bond Fund ETF (``TLT''), iShares MSCI Japan ETF (``EWJ''), and iShares
iBoxx High Yield Corporate Bond Fund (``HYG''). The Exchange represents
that LQD and GDX qualify for either (1) the initial listing criteria
set forth in Rule 915, Commentary .06 for ETFs holding non-U.S.
component securities, or (2) the generic listing standards for series
of portfolio depository receipts and index fund shares based on
international or global indexes under which a comprehensive
surveillance agreement (``CSA'') is not required, as well as (3) the
continued listing criteria in Rule 916 (for ETFs).\7\ In compliance
with its listing rules, the Exchange also represents that non-U.S.
component securities that are not subject to a CSA do not, in the
aggregate, represent more than more than 50% of the weight of LQD and
GDX.\8\
---------------------------------------------------------------------------

    \7\ The Exchange notes that the initial listing criteria for
options on ETFs that hold non-U.S. component securities are more
stringent than the maintenance listing criteria for those same ETF
options. See Rule 915, Commentary .06(a) (ii) and Rule 916,
Commentary .07.
    \8\ See Rule 915, Commentary .06(a) (ii).
---------------------------------------------------------------------------

Composition and Growth Analysis for LQD and GDX
    As stated above, position (and exercise) limits are intended to
prevent the establishment of options positions that can be used to or
potentially create incentives to manipulate the underlying market so as
to benefit options positions. The Commission has recognized that these
limits are designed to minimize the potential for mini-manipulations
and for corners or squeezes of the underlying market, as well as serve
to reduce the possibility for disruption of the options market itself,
especially in illiquid classes.\9\ LQD and GDX, as well as the ETF
components, are highly liquid and are based on a broad set of highly
liquid securities and other reference assets, as demonstrated through
the trading statistics presented in this proposal. To support the
proposed position limit increases, Cboe considered the liquidity of LQD
and GDX, the value of LQD and GDX, their components and the relevant
marketplace, the share and option volume for LQD and GDX, and, where
applicable, the availability or comparison of economically equivalent
products to options on LQD and GDX.
---------------------------------------------------------------------------

    \9\ See Securities Exchange Act Release No. 67672 (August 15,
2012), 77 FR 50750 (August 22, 2012) (SR-NYSEAmex-2012-29).
---------------------------------------------------------------------------

    Cboe collected the following trading statistics regarding shares of
and options on LQD and GDX and the values of LQD and GDX and their
components:

----------------------------------------------------------------------------------------------------------------
                                                                      Shares       Fund  market
                                   ADV 10  (ETF    ADV  (option     outstanding     cap  (USD)     Share  Value
             Product                  shares)       contracts)     (millions) 11   (millions) 12       (USD)
                                    (millions)
----------------------------------------------------------------------------------------------------------------
LQD.............................            14.1          30,300           308.1        54,113.7    130.13 (NAV)
GDX.............................            39.4         166,000           419.8        16,170.5     33.80 (NAV)
----------------------------------------------------------------------------------------------------------------

    Cboe also collected the same trading statistics, where applicable,
as above regarding a sample of other ETFs, as well as the current
position limits for options on such ETFs, to draw comparisons in
support of proposed position limit increases for options on LQD and GDX
(see further discussion below):
---------------------------------------------------------------------------

    \10\ Average daily volume (ADV) data for ETF shares and option
contracts, as well as for ETF shares and options on the comparative
ETFs presented below, are for all of 2020. Additionally, reference
to ADV in ETF shares and ETF options, and indexes herein this
proposal are for all of calendar year 2020, unless otherwise
indicated.
    \11\ Shares Outstanding and Net Asset Values (``NAV''), as well
as for the comparative ETFs presented below, are as of April 5, 2021
for all ETFs.
    \12\ Fund Market Capitalization data, as well as for the
comparative ETFs presented below, are as of January 14, 2021.

--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                             ADV  (ETF                        Shares       Fund  market                       Current
                         Product                              shares)      ADV  (option     outstanding     cap  (USD)     Share  value      position
                                                            (millions)      contracts)      (millions)      (millions)         (USD)          limits
--------------------------------------------------------------------------------------------------------------------------------------------------------
EWZ.....................................................            29.2         139,400           173.8         6,506.8     33.71 (NAV)         500,000
TLT.....................................................            11.5         111,800           103.7        17,121.3    136.85 (NAV)         500,000
EWJ.....................................................             8.2          15,500           185.3        13,860.7     69.72 (NAV)         500,000
HYG.....................................................            30.5         261,600           254.5        24,067.5     86.86 (NAV)         500,000
--------------------------------------------------------------------------------------------------------------------------------------------------------

    The Exchange believes that, overall, the liquidity in the shares of
LQD and GDX and in their overlying options, the larger market
capitalizations for each LQD and GDX, and the overall market landscape
relevant to each LQD and GDX support the proposal to increase the
position limits for each option class. Given the robust liquidity in
and value of LQD and GDX and their components, the Exchange does not
anticipate that the proposed increase in position limits would create
significant price movements as the relevant markets are large enough to
adequately absorb potential price movements that may be caused by
larger trades.
    LQD tracks the performance of the Markit iBoxx USD Liquid
Investment Grade (``IBOXIG'') Index, which is an index designed as a
subset of the broader U.S. dollar-denominated corporate bond market
which can be used as a basis for tradable products, such as ETFs, and
is comprised of over 8,000 bonds.\13\ The Exchange notes that from 2019
through 2020, ADV has grown significantly in shares of LQD and in
options on LQD, from approximately 9.7 million shares in 2019 to 14.1
million through 2020, and from approximately 8,200 option contracts in
2019 to 30,300 through 2020. LQD also continued to experience
significant growth in ADV in the first quarter of 2021 with an ADV of
approximately 140,200 option contracts. Further, LQD generally
experiences higher ADV in shares than both TLT (11.5 million shares)
and EWJ (8.2 million shares) and almost double the ADV in option
contracts than EWJ (15,500 option contracts). Options on each EWZ, TLT
and EWJ are currently subject to a position limit of 500,000
contracts--the proposed limit for options on LQD. The NAV of LQD is
also higher than, or comparable to, that of the NAV of the ETFs
underlying the options that are currently subject to a position limit
of 500,000 option contracts (as presented in the table above), which is
indicative that the total value of its underlying components is
generally higher or comparable. Per the tables above, LQD's total
market capitalization of approximately $54.1 billion is also higher
than or comparable to the total market capitalization of the ETFs
underlying the options currently subject to a position limit of
5000,000 [sic] contracts. In addition to this, the Exchange notes that,
although there are currently no options listed for trading on the
IBOXIG Index, the components \14\ of the IBOXIG Index, which can be
used in creating a basket of securities that equate to the LQD ETF, are
made up of over 8,000 bonds for which the outstanding face value of
each must be greater than or equal to $2 billion.\15\
---------------------------------------------------------------------------

    \13\ See Markit iBoxx USD Liquid Investment Grade Index,
available at https://cdn.ihsmarkit.com/www/pdf/MKT-iBoxx-USD-Liquid-Investment-Grade-Index-factsheet.pdf (January 14, 2021).
    \14\ Investment grade corporate bonds.
    \15\ See id.
---------------------------------------------------------------------------

    The Exchange believes that the total value of the bonds in the
IBOXIG Index, coupled with LQD's share and option volume, total market
capitalization, and NAV price indicates that the market is large enough
to absorb potential price movements caused by a large trade in LQD.
Also, as evidenced above, trading volume in LQD shares has increased
over the past few years and the Exchange understands that market
participants' need for options have continued to grow alongside the
ETF. Particularly, the Exchange notes that in the last year, market
participants have sought more cost-effective hedging strategies through
the use of LQD options as a result of the borrow on other fixed income
ETFs, such as HYG. Therefore, the Exchange believes that because LQD
options are being increasingly utilized as an alternative to similar
products, such as HYG options, then it is appropriate that options on
LQD be subject to the same 500,000 contract position limit that
currently exists for options on HYG.
    GDX seeks to replicate as closely as possible the price and yield
performance of the NYSE Arca Gold Miners (``GDMNTR'') Index, which is
intended to track the overall performance of companies involved in the
gold mining industry.\16\ ADV in GDX options has increased from 2019
through 2020, with an ADV of

approximately 117,400 option contracts in 2019 to an ADV of
approximately 166,000 option contracts in 2020. The Exchange notes that
ADV in GDX shares did not increase from 2019 to 2020. GDX options also
experienced an ADV of approximately 287,800 option contracts in the
first quarter of 2021. The Exchange notes that the ADV in GDX shares
(39.4 million) and options on GDX (166,000 option contracts) are
greater than the ADV in EWZ (29.2 million shares and 139,300 option
contracts), TLT (11.5 million shares and 111,800 option contracts), EWJ
(8.2 million shares and 15,500 option contracts) and HYG (30.5 million
shares and 261,600 option contracts), each of which is currently
subject to a position limit of 500,000 option contracts--the proposed
limit for options on GDX. GDX also experiences a comparable, or higher,
market capitalization (approximately $16.2 billion) than EWZ, TLT and
EWZ. The Exchange particularly notes that many of the Brazil-based gold
mining constituents included in GDX are also included in EWZ, which
tracks the investment results of an index composed of Brazilian
equities, and that the Exchange has not identified any issues with the
continued listing and trading of EWZ options or any adverse market
impact on EWZ in connection with the current 500,000 position limit in
place for EWZ options. Additionally, like that of LQD above, there is
currently no index option analogue for the GDX ETF on the GDMNTR Index
approved for options trading, however, the components of the GDMNTR
Index, which can be used to create the GDX ETF, currently must each
have a market capitalization greater than $750 million, an ADV of at
least 50,000 shares, and an average daily value traded of at least $1
million in order to be eligible for inclusion in the GDMNTR Index. The
Exchange believes that the GDMNTR Index component inclusion
requirements, as well as GDX's share and option volume and total market
capitalization, indicate that the GDX market is sufficiently large and
liquid enough to absorb price movements as a result of potentially
oversized trades.
---------------------------------------------------------------------------

    \16\ See VanEck Vectors Gold Miners ETF, available at https://
www.vaneck.com/library/vaneck-vectors-etfs/gdx-fact-sheet-pdf\
(January14, 2021).
---------------------------------------------------------------------------

Creation and Redemption for ETFs
    The Exchange believes that the creation and redemption process for
the ETFs subject to this proposal will lessen the potential for
manipulative activity with options on LQD and GDX. When an ETF provider
wants to create more shares, it looks to an Authorized Participant
(``AP'') (generally a Market Maker or other large financial
institution) to acquire the underlying components the ETF is to hold.
For instance, when an ETF is designed to track the performance of an
index, the AP can purchase all the constituent securities in the exact
same weight as the index, then deliver those shares to the ETF
provider. In exchange, the ETF provider gives the AP a block of equally
valued ETF shares, on a one-for-one fair value basis. The price is
based on the NAV, not the market value at which the ETF is trading. The
creation of new ETF units can be conducted during an entire trading day
and is not subject to position limits. This process works in reverse
where the ETF provider seeks to decrease the number of shares that are
available to trade. The creation and redemption processes for LQD and
GDX creates a direct link to the underlying components of the ETF and
serves to mitigate potential price impact of the ETF shares that might
otherwise result from increased position limits for the options on LQD
and GDX.
    The Exchange understands that the ETF creation and redemption
processes seek to keep an ETF's share price trading in line with the
product's underlying net asset value. Because an ETF trades like a
stock, its share price will fluctuate during the trading day, due to
simple supply and demand. If demand to buy an ETF is high, for
instance, an ETF's share price might rise above the value of its
underlying components. When this happens, the AP or issuer believes the
ETF may now be overpriced, so it may buy shares of the component
securities or assets and then sell ETF shares in the open market. This
may drive the ETF's share price back toward the underlying net asset
value. Likewise, if an ETF share price starts trading at a discount to
the component securities or assets it holds, the AP or issuer can buy
shares of the ETF and redeem them for the underlying components. Buying
undervalued ETF shares may drive the share price of an ETF back toward
fair value. This arbitrage process helps to keep an ETF's share price
in line with the value of its underlying portfolio.
Surveillance and Reporting Requirements
    The Exchange believes that increasing the position limits for the
options on LQD and GDX would lead to a more liquid and competitive
market environment for these options, which will benefit customers
interested in trading these products. The reporting requirement for the
options on LQD and GDX would remain unchanged. Thus, the Exchange would
still require that each Member \17\ that maintains positions in the
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 options'
positions, whether such positions are hedged and, if so, a description
of the hedge(s). Market Makers would continue to be exempt from this
reporting requirement, however, the Exchange may access Market-Maker
position information.\18\ Moreover, the Exchange's requirement that
Members file reports with the Exchange for any customer who held
aggregate large long or short positions on the same side of the market
of 200 or more option contracts of any single class for the previous
day will remain at this level for the options subject to this proposal
and will continue to serve as an important part of the Exchange's
surveillance efforts.\19\
---------------------------------------------------------------------------

    \17\ The term ``Member'' means an individual or organization
approved to exercise the trading rights associated with an ATP. ATP
Holders are deemed ``members'' under the Exchange Act. See Rule
900.2NY(5).
    \18\ The Options Clearing Corporation (``OCC'') through the
Large option Position Reporting (``LOPR'') system acts as a
centralized service provider for Member compliance with position
reporting requirements by collecting data from each Member,
consolidating the information, and ultimately providing detailed
listings of each Member's report to the Exchange, as well as
Financial Industry Regulatory Authority, Inc. (``FINRA''), acting as
its agent pursuant to a regulatory services agreement (``RSA'').
    \19\ See Rule 906 for reporting requirements.
---------------------------------------------------------------------------

    The Exchange believes that the existing surveillance procedures and
reporting requirements at the Exchange and other SROs are capable of
properly identifying disruptive and/or manipulative trading activity.
The Exchange also represents that it has adequate surveillances in
place to detect potential manipulation, as well as reviews in place to
identify potential changes in composition of LQD and GDX and continued
compliance with the Exchange's listing standards. These procedures
utilize daily monitoring of market activity via automated surveillance
techniques to identify unusual activity in both options and the
underlyings, as applicable.\20\ The Exchange also notes that large
stock holdings must be disclosed to the Commission by way of Schedules
13D or 13G,\21\ which are used to report ownership of stock which
exceeds 5% of a company's total stock issue and may assist in providing
information in

monitoring for any potential manipulative schemes.
---------------------------------------------------------------------------

    \20\ The Exchange believes these procedures have been effective
for the surveillance of trading the options subject to this proposal
and will continue to employ them.
    \21\ 17 CFR 240.13d-1.
---------------------------------------------------------------------------

    The Exchange believes that the current financial requirements
imposed by the Exchange and by the Commission adequately address
concerns regarding potentially large, unhedged positions in the options
on LQD and GDX. 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.\22\ In addition, Rule
15c3-1 \23\ imposes a capital charge on Members to the extent of any
margin deficiency resulting from the higher margin requirement.
---------------------------------------------------------------------------

    \22\ See Exchange Rules, Section 9 for a description of margin
requirements.
    \23\ 17 CFR 240.15c3-1.
---------------------------------------------------------------------------

Non-Substantive Changes
    The Exchange also proposes to make two non-substantive changes to
remove the quotation marks around HYG and Financial Select Sector SPDR
Fund (``XLF''), which would add internal consistency to the rule making
it easier to navigate to the benefit of market participants.\24\
---------------------------------------------------------------------------

    \24\ See proposed Commentary .07(f) to Rule 904.
---------------------------------------------------------------------------

2. Statutory Basis
    The Exchange believes the proposed rule change is consistent with
Section 6(b) of the Act \25\ in general, and furthers the objectives of
Sections 6(b)(5) of the Act,\26\ in that it is designed to promote just
and equitable principles of trade, 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.
Additionally, the Exchange believes the proposed rule change is
consistent with the Section 6(b)(5) \27\ requirement that the rules of
an exchange not be designed to permit unfair discrimination between
customers, issuers, brokers, or dealers.
---------------------------------------------------------------------------

    \25\ 15 U.S.C. 78f(b).
    \26\ 15 U.S.C. 78f(b)(5).
    \27\ Id.
---------------------------------------------------------------------------

    The Exchange believes that the proposed increase in position limits
for options on LQD and GDX will remove impediments to and perfect the
mechanism of a free and open market and a national market system, and,
in general, protect investors and the public interest, because it will
provide market participants with the ability to more effectively
execute their trading and hedging activities. The proposed increases
will allow market participants to more fully implement hedging
strategies in related derivative products and to further use options to
achieve investment strategies (e.g., there are other exchange-traded
products (``ETPs'') that use options on the ETFs subject to this
proposal as part of their investment strategy, and the applicable
position limits as they stand today may inhibit these other ETPs in
achieving their investment objectives, to the detriment of investors).
Also, increasing the applicable position limits may allow Market Makers
to provide the markets for these options with more liquidity in amounts
commensurate with increased consumer demand in such markets. The
proposed position limit increases may also encourage other liquidity
providers to shift liquidity, as well as encourage consumers to shift
demand, from OTC markets onto the Exchange, which will enhance the
process of price discovery conducted on the Exchange through increased
order flow.
    In addition, the Exchange believes that the structure of LQD and
GDX, the considerable market capitalization of the funds and underlying
components, and the liquidity of the markets for the applicable options
and underlying components will mitigate concerns regarding potential
manipulation of the products and/or disruption of the underlying
markets upon increasing the relevant position limits. As a general
principle, increases in market capitalizations, active trading volume,
and deep liquidity of the underlying components do not lead to
manipulation and/or disruption. This general principle applies to the
recently observed increased levels of market capitalization and trading
volume and liquidity in shares of and options on LQD and GDX (as
described above), and, as a result, the Exchange does not believe that
the options markets or underlying markets would become susceptible to
manipulation and/or disruption as a result of the proposed position
limit increases. Indeed, the Commission has previously expressed the
belief that not just increasing, but removing, position and exercise
limits may bring additional depth and liquidity to the options markets
without increasing concerns regarding intermarket manipulation or
disruption of the options or the underlying securities.\28\
---------------------------------------------------------------------------

    \28\ See Securities Exchange Act Release No. 62147 (October 28,
2005) (SR-CBOE-2005-41), at 62149.
---------------------------------------------------------------------------

    Further, the Exchange notes that the proposed rule change to
increase position limits for select actively traded options is not
novel and the Commission has approved similar proposed rule changes to
increase position limits for options on similar, highly liquid and
actively traded ETPs.\29\ Furthermore, the Exchange again notes that
that the proposed position limits for options on LQD and GDX are
consistent with existing position limits for options on other ETFs in
Rule 904, Commentary .07(f). The Exchange's surveillance and reporting
safeguards continue to be designed to deter and detect possible
manipulative behavior that might arise from increasing or eliminating
position and exercise limits in certain classes. The Exchange believes
that the current financial requirements imposed by the Exchange and by
the Commission adequately address concerns regarding potentially large,
unhedged position in the options on LQD and GDX, further promoting just
and equitable principles of trading, the maintenance of a fair and
orderly market, and the protection of investors.
---------------------------------------------------------------------------

    \29\ See Securities Exchange Act Release Nos. 88768 (April 29,
2020), 85 FR 26736 (May 5, 2020) (SR-CBOE-2020-015); 83415 (June 12,
2018), 83 FR 28274 (June 18, 2018) (SR-CBOE-2018-042); and 68086
(October 23, 2012), 77 FR 65600 (October 29, 2012) (SR-CBOE-2012-
066).
---------------------------------------------------------------------------

    Finally, the Exchange also proposes to make two non-substantive
changes to remove the quotation marks around HYG and XLF, which would
add internal consistency to the rule making it easier to navigate to
the benefit of market participants.\30\
---------------------------------------------------------------------------

    \30\ See proposed Commentary .07(f) to Rule 904.
---------------------------------------------------------------------------

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

    The Exchange does not believe that the proposed rule change will
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act. In this regard and as
indicated above, the Exchange notes that the rule change is being
proposed as a competitive response to a filing submitted by Cboe.\31\
---------------------------------------------------------------------------

    \31\ See supra note 4 (approval of Cboe filing).
---------------------------------------------------------------------------

    The Exchange does not believe the proposed rule change will impose
any burden on intramarket competition that is not necessary or
appropriate in furtherance of the purposes of the Act because the
increased position limits (and exercise limits) will be available to
all market participants and apply to each in the same manner. The
Exchange believes that the proposed rule change will provide additional
opportunities for market participants to more efficiently achieve their
investment and trading objectives.
    The Exchange does not believe that the proposed rule change will
impose any burden on intermarket competition that is not necessary or
appropriate in furtherance of the Act. On the contrary,

the Exchange believes the proposal promotes competition because it may
attract additional order flow from the OTC market to exchanges, which
would in turn compete amongst each other for those orders. The Exchange
believes market participants would benefit from being able to trade
options with increased position limits in an exchange environment in
several ways, including but not limited to the following: (1) Enhanced
efficiency in initiating and closing out positions; (2) increased
market transparency; and (3) heightened contra-party creditworthiness
due to the role of OCC as issuer and guarantor. The Exchange notes that
other options exchanges may choose to file similar proposals with the
Commission to increase position limits on options on LQD and GDX.

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

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

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

    Because the foregoing 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 for 30 days from the date on which it was filed, or
such shorter time as the Commission may designate, it has become
effective pursuant to Section 19(b)(3)(A) of the Act \32\ and Rule 19b-
4(f)(6) thereunder.\33\
---------------------------------------------------------------------------

    \32\ 15 U.S.C. 78s(b)(3)(A).
    \33\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)(iii)
requires a self-regulatory organization to give the Commission
written notice of its intent to file the proposed rule change, along
with a brief description and text of 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 \34\ normally does not become operative for 30 days after the date
of its filing. However, Rule 19b-4(f)(6)(iii) \35\ 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 so that
the proposed rule change may become operative upon filing. The Exchange
states that waiver of the operative delay would be consistent with the
protection of investors and the public interest because it will ensure
fair competition among the exchanges by allowing the Exchange to
immediately increase the relevant position limits, which will provide
consistency for Exchange Members that are also members at Cboe where
these increased position limits are currently in place. The Commission
notes that the Exchange's corresponding exercise limits for the options
covered by this proposal also would be increased, consistent with the
increased exercise limits for these options already in place at Cboe.
For these reasons, the Commission believes that waiver of the 30-day
operative delay is consistent with the protection of investors and the
public interest. Therefore, the Commission hereby waives the operative
delay and designates the proposal as operative upon filing.\36\
---------------------------------------------------------------------------

    \34\ 17 CFR 240.19b-4(f)(6).
    \35\ 17 CFR 240.19b-4(f)(6)(iii).
    \36\ For purposes only of waiving the 30-day operative delay,
the Commission also 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. If the Commission
takes such action, the Commission shall institute proceedings to
determine whether the proposed rule change should be approved or
disapproved.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to [email protected]. Please include
File Number SR-NYSEAMER-2021-45 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NYSEAMER-2021-45. 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 website (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 website 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 such filing also will be available for inspection
and copying at the principal office of the Exchange. All comments
received will be posted without change. Persons submitting comments are
cautioned that we do not redact or edit personal identifying
information from comment submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File Number SR-NYSEAMER-2021-45, and should be
submitted on or before January 18, 2022.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\37\
---------------------------------------------------------------------------

    \37\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Jill M. Peterson,
Assistant Secretary.
[FR Doc. 2021-27927 Filed 12-23-21; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: July 12, 2007 (Volume 72, Number 133)]
[Notices]
[Page 38071]
[DOCID:fr12jy07-46]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EC07-97-001]

Ecofin Holdings Limited et al.; Notice of Filing

July 5, 2007.
    Take notice that on June 28, 2007, Ecofin Holdings Limited et al.,
submitted an amended application for Request for Blanket Authorization
to Acquire Securities under section 203 of the Federal Power Act on
behalf of itself, its investment management subsidiaries, certain
managed investment funds and investment accounts.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date.
Anyone filing a motion to intervene or protest must serve a copy of
that document on the Applicant and all the parties in this proceeding.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at: http://www.ferc.gov.
 Persons unable to file electronically should submit an

original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at: http://www.ferc.gov, using

the ``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For

TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern Time on July 12, 2007.

Kimberly D. Bose,
 Secretary.
 [FR Doc. E7-13514 Filed 7-11-07; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register: August 7, 2009 (Volume 74, Number 151)]
[Rules and Regulations]
[Page 39543-39545]
[DOCID:fr07au09-4]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2009-0601; FRL-8431-8]

Inert Ingredients; Extension of Effective Date of Revocation of
Certain Tolerance Exemptions with Insufficient Data for Reassessment

AGENCY: Environmental Protection Agency (EPA).

ACTION: Direct final rule.

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

SUMMARY: This document moves the effective date of the revocation of
six inert ingredient tolerance exemptions with insufficient data for
reassessment as set forth in the Federal Register on August 4, 2008 (73
FR 45312).

DATES: In the final rule published August 9, 2006 (71 FR 45415), and
delayed on August 4, 2008 (73 FR 45312):
     1. The effective date is delayed from August 9, 2009, to October
9, 2009, for the following amendments to Sec.  180.910: 2.m., n., and
cc.
     2. The effective date is delayed from August 9, 2009, to October
9, 2009, for the following amendments to Sec.  180.930: 4.t., u., and
v.
     Objections and requests for hearings must be received on or before
October 6, 2009, and must be filed in accordance with the instructions
provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY
INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2009-0601. All documents in the
docket are listed in the index for the docket. 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, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available in the electronic docket at http://www.regulations.gov, or,
if only available in hard copy, at the OPP Regulatory Public Docket in
Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr.,
Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m.,
Monday through Friday, excluding legal holidays. The Docket Facility
telephone number is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Kerry Leifer, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Does this Action Apply to Me?

     You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
      Crop production (NAICS code 111).
      Animal production (NAICS code 112).
      Food manufacturing (NAICS code 311).
      Pesticide manufacturing (NAICS code 32532).
     This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.

II. Background and Statutory Findings

A. Background

     In a final rule published in the Federal Register on August 9,
2006 (71 FR 45415) (FRL-8084-1), EPA revoked inert ingredient tolerance
exemptions because insufficient data were available to the Agency to
make the safety determination required by Federal Food, Drug, and
Comestic Act (FFDCA) section 408(c)(2). In reassessing the safety of
the tolerance exemptions, EPA considered the validity, completeness,
and reliability of the data that are available to the Agency [FFDCA
section 408 (b)(2)(D)] and the available information concerning the
special susceptibility of infants and children (including developmental
effects from in utero exposure) [FFDCA section 408

(b)(2)(C)]. EPA concluded it had insufficient data to make the safety
finding of FFDCA section 408(c)(2) and revoked the inert ingredient
tolerance exemptions identified in the final rule under 40 CFR 180.910,
180.920, 180.930, and 180.940, with the revocations effective on August
9, 2008.
     In a subsequent direct final rule published in the Federal
Register on August 4, 2008 (73 FR 45312) (FRL-8372-7), EPA moved the
effective date of the revocation of certain inert ingredient tolerance
exemptions from August 9, 2008, until August 9, 2009. This
determination was made based on requests for an extension of the
revocation date from pesticide registrants and inert ingredient
manufacturers who had demonstrated their intent to support certain
inert ingredient tolerance exemptions and who had provided data
development plans and schedules for data submission to the Agency.

B. Moving the Effective Date of the Revocation for Six Tolerance
Exemptions

     In the case of six of the revoked tolerance exemptions, EPA has
received petitions for the establishment of tolerance exemptions which
included the submission of data for these inert ingredients. Notices of
filing of these petitions (PP 8E7466 and PP 8E7478) were published in
the Federal Register on March 25, 2009 (74 FR 12856) (FRL-8399-4). The
Agency has not yet fully completed the risk assessments needed to
evaluate these petitions and to make a safety finding. EPA, therefore,
concludes that additional time is necessary to complete the safety
determinations for these six tolerance exemptions and that the
effective date of the revocation of the these tolerance exemptions
should be moved by two months to October 9, 2009.

C. What is the Agency's Authority for Taking this Action?

     A ``tolerance'' represents the maximum level for residues of
pesticide chemicals legally allowed in or on raw agricultural
commodities and processed foods. Section 408 of FFDCA, 21 U.S.C. 346a,
as amended by FQPA, Public Law 104-170, authorizes the establishment of
tolerances, exemptions from tolerance requirements, modifications in
tolerances, and revocation of tolerances for residues of pesticide
chemicals in or on raw agricultural commodities and processed foods.
Without a tolerance or exemption, food containing pesticide residues is
considered to be unsafe and therefore ``adulterated'' under FFDCA
section 402(a), 21 U.S.C. 342(a). Such food may not be distributed in
interstate commerce (21 U.S.C. 331(a)). For a food-use pesticide to be
sold and distributed, the pesticide must not only have appropriate
tolerances under FFDCA, but also must be registered under the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA) (7 U.S.C. 136 et
seq.). Food-use pesticides not registered in the United States must
have tolerances in order for commodities treated with those pesticides
to be imported into the United States. Under FFDCA section
408(e)(1)(B), 21 U.S.C. 346a(e)(1)(B), EPA may take action
establishing, modifying, suspending, or revoking a tolerance exemption.

III. Delayed Effective Date for Certain Tolerance Exemptions

     The amendatory designations listed in this unit are reprinted from
the final rule published in the Federal Register issue of August 4,
2008 (73 FR 45312) for the convenience of the user. The structure
mirrors the amendatory designations in the original document. The
amendatory designations shown are those with the effective date delayed
until October 9, 2009.

Section 180.910

     m. [alpha]-(p-Nonylphenyl)-[omega]-hydroxypoly(oxyethylene)
mixture of dihydrogen phosphate and monohydrogen phosphate esters and
the corresponding ammonium, calcium, magnesium, monoethanolamine,
potassium, sodium, and zinc salts of the phosphate esters; the nonyl
group is a propylene trimer isomer and the poly (oxyethylene) content
averages 4-14 moles or 30 moles.
     n. [alpha]-(p-Nonylphenyl)-[omega]-hydroxypoly(oxyethylene)
sulfate, ammonium, calcium, magnesium, potassium, sodium, and zinc
salts; the nonyl group is a propylene trimer isomer and the
poly(oxyethylene) content averages 4 moles.
     cc. [alpha]-[p-(1,1,3,3-Tetramethylbutyl)phenyl]-[omega]-
hydroxypoly(oxyethylene) produced by the condensation of 1 mole of p-
(1,1,3,3-tetramethylbutyl)phenol with a range of 1-14 or 30-70 moles of
ethylene oxide: if a blend of products is used, the average range
number of moles of ethylene oxide reacted to produce any product that
is a component of the blend shall be in the range of 1-14 or 30-70.

Section 180.930

     t. [alpha]-(p-Nonylphenyl)-[omega]-hydroxypoly(oxyethylene)
mixture of dihydrogen phosphate and monohydrogen phosphate esters and
the corresponding ammonium, calcium, magnesium, monoethanolamine,
potassium, sodium, and zinc salts of the phosphate esters; the nonyl
group is a propylene trimer isomer and the poly(oxyethylene) content
averages 4-14 moles.
     u. [alpha]-(p-Nonylphenyl)-[omega]-hydroxypoly(oxyethylene)
sulfate, and its ammonium, calcium, magnesium, potassium, sodium, and
zinc salts; the nonyl group is a propylene trimer isomer and the
poly(oxyethylene) content averages 4 moles.
     v. [alpha]-(p-Nonylphenyl)-[omega]-hydroxypoly(oxyethylene)
sulfate, and its ammonium, calcium, magnesium, monoethanolamine,
potassium, sodium, and zinc salts; the nonyl group is a propylene
trimer isomer and the poly(oxyethylene) content averages 4-14 or 30-90
moles of ethyiene oxide.

IV. Statutory and Executive Order Reviews

     This rule changes the effective date of the revocation of certain
tolerance exemptions under section 408(d) of FFDCA. The Office of
Management and Budget (OMB) has exempted tolerance exemption actions
from review under Executive Order 12866, entitled Regulatory Planning
and Review (58 FR 51735, October 4, 1993). Because this rule has been
exempted from review under Executive Order 12866 due to its lack of
significance, this rule is not subject to Executive Order 13211,
Actions Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May 22, 2001). This rule does not
contain any information collections subject to OMB approval under the
Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose any
enforceable duty or contain any unfunded mandate as described under
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law
104-4). Nor does it require any special considerations under Executive
Order 12898, entitled Federal Actions to Address Environmental Justice
in Minority Populations and Low-Income Populations (59 FR 7629,
February 16, 1994); or OMB review or any Agency action under Executive
Order 13045, entitled Protection of Children from Environmental Health
Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does
not involve any technical standards that would require Agency
consideration of voluntary consensus standards pursuant to section
12(d) of the National Technology Transfer and Advancement Act of 1995
(NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note).

     Pursuant to the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), the Agency hereby certifies that this action will not have a
significant negative economic impact on a substantial number of small
entities.
     In addition, the Agency has determined that this action will not
have a substantial direct effect on States, on the relationship between
the national government and the States, or on the distribution of power
and responsibilities among the various levels of government, as
specified in Executive Order 13132, entitled Federalism (64 FR 43255,
August 10, 1999). Executive Order 13132 requires EPA to develop an
accountable process to ensure ``meaningful and timely input by State
and local officials in the development of regulatory policies that have
federalism implications.'' ``Policies that have federalism
implications'' is defined in the Executive Order to include regulations
that have ``substantial direct effects on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government.'' This rule directly regulates growers, food processors,
food handlers, and food retailers, not States. This action does not
alter the relationships or distribution of power and responsibilities
established by Congress in the preemption provisions of section
408(n)(4) of FFDCA. For these same reasons, the Agency has determined
that this rule does not have any ``tribal implications'' as described
in Executive Order 13175, entitled Consultation and Coordination with
Indian Tribal Governments (65 FR 67249, November 9, 2000). Executive
Order 13175 requires EPA to develop an accountable process to ensure
``meaningful and timely input by tribal officials in the development of
regulatory policies that have tribal implications.'' ``Policies that
have tribal implications'' is defined in the Executive order to include
regulations that have ``substantial direct effects on one or more
Indian tribes, on the relationship between the Federal Government and
the Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes.'' This rule will not
have substantial direct effects on tribal governments, on the
relationship between the Federal Government and Indian tribes, or on
the distribution of power and responsibilities between the Federal
Government and Indian tribes, as specified in Executive Order 13175.
Thus, Executive Order 13175 does not apply to this rule.

List of Subjects in 40 CFR Part 180

     Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

    Dated: August 4, 2009.
G. Jeffrey Herndon,
Acting Director, Registration Division, Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
 1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

Sec. 180.910  [Amended]

0
 2. In the final rule published August 9, 2006 (71 FR 45415), and
delayed on August 4, 2008 (73 FR 45312), the effective date is delayed
from August 9, 2009, to October 9, 2009, for the following amendments
to Sec.  180.910: 2.m., n., and cc.

Sec. 180.930  [Amended]

0
 3. In the final rule published August 9, 2006 (71 FR 45415), and
delayed on August 4, 2008 (73 FR 45312), the effective date is delayed
from August 9, 2009, to October 9, 2009, for the following amendments
to Sec.  180.930: 4.t., u., and v.
[FR Doc. E9-19057 Filed 8-6-09; 8:45 am]

BILLING CODE 6560-50-S