[Federal Register Volume 81, Number 116 (Thursday, June 16, 2016)]
[Rules and Regulations]
[Pages 39208-39211]
[FR Doc No: 2016-14181]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R03-OAR-2015-0838; FRL-9947-76-Region 3]

Approval and Promulgation of Air Quality Implementation Plans;
Virginia Infrastructure Requirements for the 2012 Fine Particulate
Matter National Ambient Air Quality Standards

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: The Environmental Protection Agency (EPA) is approving a state
implementation plan (SIP) revision submitted by the Commonwealth of
Virginia (Virginia) pursuant to the Clean Air Act (CAA). Whenever new
or revised national ambient air quality standards (NAAQS) are
promulgated, the CAA requires states to submit a plan to address basic
program elements, including but not limited to regulatory structure,
monitoring, modeling, legal authority, and adequate resources necessary
to assure implementation, maintenance, and enforcement of the NAAQS.
These elements are referred to as infrastructure requirements. The
Commonwealth of Virginia made a submittal addressing the infrastructure
requirements for the 2012 fine particulate matter (PM2.5)
NAAQS.

DATES: This final rule is effective on July 18, 2016.

ADDRESSES: EPA has established a docket for this action under Docket ID
Number EPA-R03-OAR-2015-0838. All documents in the docket are listed in
the www.regulations.gov Web site. Although listed in the electronic
docket, some information is not publicly available, i.e., 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 through www.regulations.gov or may be viewed during normal
business hours at the Air Protection Division, U.S. Environmental
Protection Agency, Region III, 1650 Arch Street, Philadelphia,
Pennsylvania 19103. Copies of the state submittal are available at
Virginia Department of Environmental Quality, 629 East Main Street,
Richmond, Virginia 23219.

FOR FURTHER INFORMATION CONTACT: Ellen Schmitt,<PHONE_NUMBER>, or by
email at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    On July 18, 1997, the EPA promulgated a new 24-hour and a new
annual NAAQS for PM2.5 (62 FR 38652). Subsequently, on
December 14, 2012, the EPA revised the level of the health based
(primary) annual PM2.5 standard to 12 micrograms per cubic
meter ([micro]g/m\3\). See 78 FR 3086 (January 15, 2013).\1\
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    \1\ In EPA's 2012 PM2.5 NAAQS revision, EPA left
unchanged the existing welfare (secondary) standards for
PM2.5 to address PM related effects such as visibility
impairment, ecological effects, damage to materials and climate
impacts. This includes an annual secondary standard of 15 [mu]g/m\3\
and a 24-hour standard of 35 [mu]g/m\3\.
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    Pursuant to section 110(a)(1) of the CAA, states are required to
submit SIPs meeting the applicable requirements of section 110(a)(2)
within three years after promulgation of a new or revised NAAQS or
within such shorter period as EPA may prescribe. Section 110(a)(2)
requires states to address basic SIP elements such as requirements for
monitoring, basic program requirements, and legal authority that are
designed to assure attainment and maintenance of the NAAQS. Section
110(a) imposes the obligation upon states to make a SIP submission to
EPA for a new or revised NAAQS, but the contents of that submission may
vary depending upon the facts and circumstances. In particular, the
data and analytical tools available at the time the state develops and
submits the SIP for a new or revised NAAQS affect the content of the
submission. The content of such SIP submission may also vary depending
upon what provisions the state's existing SIP already contains.

II. Summary of SIP Revision

    On July 16, 2015, the Commonwealth of Virginia, through the
Virginia Department of Environmental Quality (VADEQ), submitted a SIP
revision that addresses the infrastructure elements specified in
section 110(a)(2) of the CAA necessary to implement, maintain, and
enforce the 2012 PM2.5 NAAQS.\2\ On March 7, 2016 (81 FR
11711), EPA published a notice of proposed rulemaking (NPR) proposing
approval of the Virginia July 16, 2015 submittal. In the NPR, EPA
proposed approval of the following infrastructure elements: Section
110(a)(2)(A), (B), (C), (D)(i)(II) (prevention of significant
deterioration), (D)(ii), (E), (F), (G), (H), (J), (K), (L), and (M).
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    \2\ To clarify, the ``2013 PM2.5 NAAQS'' referred to
in the Virginia SIP submittal is the same as the ``2012
PM2.5 NAAQS'' EPA refers to in this rulemaking action.
The final rule for this NAAQS was signed by the EPA Administrator on
December 14, 2012, thereby it has been called the ``2012
PM2.5 NAAQS.'' However, the final rule was published in
the Federal Register on January 15, 2013, with an effective date of
March 13, 2013, resulting in it also being referred to as the ``2013
PM2.5 NAAQS.''
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    At this time, EPA is not taking action on section
110(a)(2)(D)(i)(I) of the CAA relating to interstate transport of
emissions because Virginia's July 16, 2016 infrastructure SIP submittal
did not include provisions for this element; therefore EPA will take
later, separate action on section 110(a)(2)(D)(i)(I) for the 2012
PM2.5 NAAQS for Virginia as explained in the NPR.
Additionally, EPA is not at this time taking action on section
110(a)(2)(D)(i)(II) for visibility protection for the 2012
PM2.5 NAAQS as explained in the NPR. Although Virginia's
infrastructure SIP submittal for the 2012 PM2.5 NAAQS
referred to Virginia's regional haze SIP for section
110(a)(2)(D)(i)(II) for visibility protection, EPA intends to take
later, separate action on Virginia's submittal for these elements as
explained in the NPR and the Technical Support Document (TSD) which
accompanied the NPR. Finally, Virginia did not submit section
110(a)(2)(I) which pertains to the nonattainment requirements of part
D, Title I of the CAA, because this element is not required to be
submitted by the 3-year submission deadline of section 110(a)(1) and
will be addressed in a separate process if necessary.
    The rationale supporting EPA's proposed rulemaking action,
including the scope of infrastructure SIPs in general, is explained in
the published NPR and the TSD accompanying the NPR and will not be
restated here. The NPR and TSD are available in the docket for this
rulemaking at www.regulations.gov, Docket ID Number EPA-R03-OAR-2015-
0838. No public comments were received on the NPR.

III. Final Action

    EPA is approving, as a revision to the Virginia SIP, the following
elements of Virginia's July 16, 2015 SIP revision for the 2012
PM2.5 NAAQS: Section 110(a)(2)(A), (B), (C), (D)(i)(II)
(prevention of significant deterioration), (D)(ii), (E), (F), (G), (H),
(J), (K), (L), and (M). Virginia's SIP revision provides the basic
program elements specified in section 110(a)(2) necessary to implement,
maintain, and enforce the 2012 PM2.5 NAAQS. This final
rulemaking action does not include action on sections
110(a)(2)(D)(i)(I) (interstate transport of emissions), and (D)(i)(II)
(visibility protection) for the 2012 PM2.5 NAAQS as
previously discussed. Additionally, EPA is not taking action on section
110(a)(2)(I) which pertains to the nonattainment planning requirements
of part D, title I of the CAA, because this element is not required to
be submitted by the 3-year submission deadline of section 110(a)(1) of
the CAA, and will be addressed in a separate process if necessary.

IV. General Information Pertaining to SIP Submittals From the
Commonwealth of Virginia

    In 1995, Virginia adopted legislation that provides, subject to
certain conditions, for an environmental assessment (audit)
``privilege'' for voluntary compliance evaluations performed by a
regulated entity. The legislation further addresses the relative burden
of proof for parties either asserting the privilege or seeking
disclosure of documents for which the privilege is claimed. Virginia's
legislation also provides, subject to certain conditions, for a penalty
waiver for violations of environmental laws when a regulated entity
discovers such violations pursuant to a voluntary compliance evaluation
and voluntarily discloses such violations to the Commonwealth and takes
prompt and appropriate measures to remedy the violations. Virginia's
Voluntary Environmental Assessment Privilege Law, Va. Code Sec. 10.1-
1198, provides a privilege that protects from disclosure documents and
information about the content of those documents that are the product
of a voluntary environmental assessment. The Privilege Law does not
extend to documents or information that: (1) Are generated or developed
before the commencement of a voluntary environmental assessment; (2)
are prepared independently of the assessment process; (3) demonstrate a
clear, imminent and substantial danger to the public health or
environment; or (4) are required by law.
    On January 12, 1998, the Commonwealth of Virginia Office of the
Attorney General provided a legal opinion that states that the
Privilege law, Va. Code Sec. 10.1-1198, precludes granting a privilege
to documents and information ``required by law,'' including documents
and information ``required by federal law to maintain program
delegation, authorization or approval,'' since Virginia must ``enforce
federally authorized environmental programs in a manner that is no less
stringent than their federal counterparts. . . .'' The opinion
concludes that ``[r]egarding Sec.  10.1-1198, therefore, documents or
other information needed for civil or criminal enforcement under one of
these programs could not be privileged because such documents and

information are essential to pursuing enforcement in a manner required
by federal law to maintain program delegation, authorization or
approval.''
    Virginia's Immunity law, Va. Code Sec. 10.1-1199, provides that
``[t]o the extent consistent with requirements imposed by federal
law,'' any person making a voluntary disclosure of information to a
state agency regarding a violation of an environmental statute,
regulation, permit, or administrative order is granted immunity from
administrative or civil penalty. The Attorney General's January 12,
1998 opinion states that the quoted language renders this statute
inapplicable to enforcement of any federally authorized programs, since
``no immunity could be afforded from administrative, civil, or criminal
penalties because granting such immunity would not be consistent with
federal law, which is one of the criteria for immunity.''
    Therefore, EPA has determined that Virginia's Privilege and
Immunity statutes will not preclude the Commonwealth from enforcing its
program consistent with the federal requirements. In any event, because
EPA has also determined that a state audit privilege and immunity law
can affect only state enforcement and cannot have any impact on federal
enforcement authorities, EPA may at any time invoke its authority under
the CAA, including, for example, sections 113, 167, 205, 211 or 213, to
enforce the requirements or prohibitions of the state plan,
independently of any state enforcement effort. In addition, citizen
enforcement under section 304 of the CAA is likewise unaffected by
this, or any, state audit privilege or immunity law.

V. Statutory and Executive Order Reviews

A. General Requirements

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the CAA and applicable
federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. Accordingly, this
action merely approves state law as meeting federal requirements and
does not impose additional requirements beyond those imposed by state
law. For that reason, this action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Orders
12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21,
2011);
     does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     does not have federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     is not subject to requirements of section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    The SIP is not approved to apply on any Indian reservation land as
defined in 18 U.S.C. 1151 or in any other area where EPA or an Indian
tribe has demonstrated that a tribe has jurisdiction. In those areas of
Indian country, the rule does not have tribal implications and will not
impose substantial direct costs on tribal governments or preempt tribal
law as specified by Executive Order 13175 (65 FR 67249, November 9,
2000).

B. Submission to Congress and the Comptroller General

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this action and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).

C. Petitions for Judicial Review

    Under section 307(b)(1) of the CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by August 15, 2016. Filing a petition for
reconsideration by the Administrator of this final rule does not affect
the finality of this action for the purposes of judicial review nor
does it extend the time within which a petition for judicial review may
be filed, and shall not postpone the effectiveness of such rule or
action. This action, which satisfies certain infrastructure
requirements of section 110(a)(2) of the CAA for the 2012
PM2.5 NAAQS for the Commonwealth of Virginia, may not be
challenged later in proceedings to enforce its requirements. (See
section 307(b)(2).)

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Particulate matter, Reporting and recordkeeping
requirements.

    Dated: May 27, 2016.
Shawn M. Garvin,
Regional Administrator, Region III.
    40 CFR part 52 is amended as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

0
1. The authority citation for part 52 continues to read as follows:

    Authority:  42 U.S.C. 7401 et seq.

Subpart VV--Virginia

0
2. In Sec.  52.2420, the table in paragraph (e) is amended by adding,
to the end of the table, an entry for ``Section 110(a)(2)
Infrastructure Requirements for the 2012 Particulate Matter NAAQS.''
The added text reads as follows:

Sec.  52.2420  Identification of plan.

* * * * *
    (e) * * *

----------------------------------------------------------------------------------------------------------------
   Name of non-regulatory SIP         Applicable            State
            revision                geographic area    submittal date  EPA approval date  Additional explanation
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
Section 110(a)(2)                Statewide...........         7/16/15  6/16/16, [Insert   Docket #2015-0838.
 Infrastructure Requirements                                            Federal Register   This action addresses
 for the 2012 Particulate                                               citation].         the following CAA
 Matter NAAQS.                                                                             elements, or portions
                                                                                thereof:
                                                                                110(a)(2)(A), (B),
                                                                                (C), (D)(i)(II)(PSD),
                                                                                (D)(ii), (E), (F),
                                                                                (G), (H), (J), (K),
                                                                                (L), and (M).
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[FR Doc. 2016-14181 Filed 6-15-16; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register: February 3, 2010 (Volume 75, Number 22)]
[Notices]
[Page 5640-5641]
[DOCID:fr03fe10-102]

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DEPARTMENT OF TRANSPORTATION

Pipeline and Hazardous Materials Safety Administration

[Docket No. PHMSA-2008-0211]

Pipeline Safety: Implementation of Revised Incident/Accident
Report Forms for Distribution Systems, Gas Transmission and Gathering
Systems, and Hazardous Liquid Systems

AGENCY: Pipeline and Hazardous Materials Safety Administration (PHMSA),
DOT.

ACTION: Notice; Issuance of Advisory Bulletin.

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SUMMARY: This notice advises owners and operators of gas pipeline
facilities and hazardous liquid pipeline facilities that the incident/
accident report forms for their pipeline systems were recently revised
and should be used for all incidents and accidents occurring on or
after January 1, 2010.

FOR FURTHER INFORMATION CONTACT: Jamerson Pender, Information Resources
Manager,<PHONE_NUMBER> or by e-mail at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    The Pipeline and Hazardous Materials Safety Administration (PHMSA)
requires that an operator of a covered pipeline facility file a written
report within 30 days of certain adverse events, defined by regulation
as either

an incident or accident, 49 CFR 191.1-191.27, 195.48-195.63 (2008).\1\
PHMSA further requires that those reports be submitted to the agency on
one of three standardized forms: (1) PHMSA Form F 7100.1, Incident
Report--Gas Distribution Pipelines, (2) PHMSA Form F 7100.2, Incident
Report--Gas Transmission and Gathering Systems, and (3) PHMSA Form F
7000-1--Accident Report for Hazardous Liquid Pipeline Systems. PHMSA
uses the information collected from these forms to identify trends in
the occurrence of safety-related problems, to appropriately target its
performance of risk-based inspections, and to assess the overall
efficacy of its regulatory program.
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    \1\ Reportable events are referred to as ``incidents'' for gas
pipelines, 49 CFR 191.3, and ``accidents'' for hazardous liquid
pipelines, 49 CFR 195.50. An operator may also be required to file a
supplemental report in certain circumstances.
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    PHMSA published a Federal Register notice on September 4, 2008 (73
FR 51697) inviting public comment on a proposal to revise the incident/
accident report forms. PHMSA stated that the proposed revisions were
needed to make the information collected more useful to all those
concerned with pipeline safety and to provide additional, and in some
instances more detailed, data for use in the development and
enforcement of its risk-based regulatory program. PHMSA published a
subsequent Federal Register notice on October 30, 2008 (73 FR 64661) to
extend the comment period to December 12, 2008.
    On August 17, 2009, PHMSA published a Federal Register notice (74
FR 41496) to respond to comments, provide the public with an additional
30 days to comment on the proposed revisions to the incident/accident
report forms, including the form instructions, and announce that the
revised Information Collections would be submitted to the Office of
Management and Budget (OMB) for approval. Several comments were
received in response to the August 17, 2009, notice. PHMSA reviewed the
comments and revised the forms as applicable.
    PHMSA has recently received OMB approval to use the newly revised
forms that are incorporated under OMB Control No. 2137-0522, ``Incident
and Annual Reports for Gas Pipeline Operators'' and OMB Control No.
2137-0047, ``Transportation of Hazardous Liquids by Pipeline:
Recordkeeping and Accident Reporting.'' The revised forms reflect
comments that were received throughout the notice and comment periods.
These forms should be used for all incidents/accidents that have
occurred on or after January 1, 2010.

Advisory Bulletin (ADB-2010-01)

    To: Owners and Operators of Gas Pipeline Facilities and Hazardous
Liquid Pipeline Facilities.
    Subject: Implementation of PHMSA`s Revised Incident/Accident Report
Forms for Gas Distribution Systems, Gas Transmission and Gathering
Systems, and Hazardous Liquid Systems.
    Advisory: This notice advises owners and operators of gas pipeline
facilities and hazardous liquid pipeline facilities that the incident/
accident report forms for their pipeline systems were recently revised
and should be used for all incidents/accidents occurring on or after
January 1, 2010. Until PHMSA completes development of a new electronic
online data entry system for the new forms (approximately March 1,
2010) operators should file hard copy forms for incidents/accidents
occurring on or after January 1, 2010. Copies of the new forms and
instructions are available at http://phmsa.dot.gov/pipeline/library/
forms or http://opsweb.phmsa.dot.gov/. Hard copy forms should be
submitted to the attention of the Information Resources Manager at the
address listed in the instructions. As an alternative, completed forms
that include signatures may be submitted to the Information Resources
Manager by e-mail to<EMAIL_ADDRESS>Any questions regarding
this new requirement can be directed to the Office of Pipeline Safety
operator helpline at<PHONE_NUMBER>.

    Issued in Washington, DC on January 25, 2010.
Jeffrey D. Wiese,
Associate Administrator for Pipeline Safety.
[FR Doc. 2010-2240 Filed 2-2-10; 8:45 am]
BILLING CODE 4910-60-P


[Federal Register Volume 83, Number 201 (Wednesday, October 17, 2018)]
[Notices]
[Pages 52581-52586]
[FR Doc No: 2018-22540]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-84410; File No. SR-LCH SA-2018-004]

Self-Regulatory Organizations; LCH SA; Order Approving Proposed
Rule Change Relating to Implementation of Electronic Exercise Platform

October 11, 2018.

I. Introduction

    On August 24, 2018, Banque Centrale de Compensation, which conducts
business under the name LCH SA (``LCH SA''), filed with the Securities
and Exchange Commission (``Commission''), pursuant to Section 19(b)(1)
of the Securities Exchange Act of 1934 (``Act''),\1\ and Rule 19b-4
thereunder,\2\ a proposed rule change (the ``Proposed Rule Change'') to
amend its (i) CDS Clearing Rule Book (``Rule Book''), (ii) CDS Clearing
Supplement (``Supplement''), and (iii) CDS Clearing Procedures
(``Procedures'') to incorporate new terms and to make conforming,
clarifying, and clean-up changes to implement a new electronic exercise
platform (``EEP'') for the exercise of options on index credit default
swaps (``CDS Options'') by Clearing Members and their Clients. The
proposed rule change was published for comment in the Federal Register
on September 5, 2018.\3\ The Commission has not received any comments
on the proposed rule change. For the reasons discussed below, the
Commission is approving the proposed rule change.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ Securities Exchange Act Release No. 34-83983 (Aug. 29,
2018), 83 FR 45155 (Sept. 5, 2018) (SR-LCH SA-2018-004)
(``Notice'').
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II. Description of the Proposed Rule Change

    The proposed rule change would create an EEP for CDS Options to
capture and support decisions to exercise CDS Options by Clearing
Members and their Clients.\4\ Currently, LCH SA matches a Clearing
Member or Client holding the option to either buy or sell protection on
the underlying index credit default swap (``CDS'') (``CDS Option
buyer''), with a Clearing Member or Client obligated to either buy or
sell protection, as applicable, on the underlying index CDS (``CDS
Option seller'') (this transaction is a ``matched pair'').\5\ The
creation of the matched pair allows the CDS Option buyer to exercise or
abandon the CDS Option. If the CDS Option buyer exercises the CDS
Option, the CDS Option buyer must notify the CDS Option seller manually
via email and then inform LCH SA that the exercise notice has been
successfully delivered. LCH SA then manually executes the exercise
decisions and updates its risk system.
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    \4\ Capitalized terms used herein but not otherwise defined have
the meaning set forth in the Rule Book, Supplement, and Procedures,
which are available at https://www.lch.com/resources/rules-and-regulations/sa-rulebooks.
    \5\ For more information regarding the operation of CDS Options,
see Exchange Act Release No. 34-82109 (Nov. 17, 2017), 82 FR 55905
(Nov. 24, 2017) (SR-LCH SA 2017-006; SR-LCH SA-2017-007).
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    Under the proposed rule change, LCH would still create matched
pairs to allow the exercise or abandonment of a CDS Option. The
proposed rule change would, however, eliminate the manual notification
process between the CDS Option buyer and CDS Option seller by
providing, through the EEP, an electronic process for exercising CDS
Options. Specifically, a CDS Option buyer would submit an intent
through the EEP to either exercise or abandon the CDS Option (``Option
Intent''). If validly submitted before the expiration date of the CDS
Option, the Option Intent would serve as notice to the CDS Option
seller that the CDS Option buyer is going to exercise or abandon the
CDS Option. The proposed rule change would require Clearing Members and
Clients to use the EEP system to exercise CDS Options. The proposed
rule change would also require Clearing Members to delegate to Clients
the ability to directly exercise CDS Options related to their cleared
transactions (``Client Cleared Transactions''). The EEP would capture
CDS Option buyers' exercise decisions in real time and notify the
relevant CDS Option sellers in real time. In addition, the EEP would
validate and check exercise decisions and facilitate the anonymous
exercise of CDS Options.
    The proposed rule change would create and implement the EEP through
amendments to LCH SA's Rule Book, Supplement, and Procedures. These
amendments are summarized below according to how they affect: (i) The
exercise of CDS Options directly by Clients; (ii) the operational
process for the exercise of CDS Options in the EEP; and (iii) technical
specifications of the EEP. The proposed rule change would also make
other changes to the Rule Book, Supplement, and Procedures, as
discussed below.

A. Exercise of CDS Options Directly by Clients

    The proposed rule change would add new provisions to allow for the
exercise of CDS Options in the EEP directly by Clients.\6\
Specifically, with respect to those CDS Options transactions that are
Client Cleared Transactions, new Section 6.4 of the Supplement would
require Clearing Members to designate their relevant Clients to act on
their behalf via the EEP.\7\ The Client so designated would be the
Exercise Delegation Beneficiary. Moreover, the proposed rule change
would amend the Rule Book to require that Clearing Members delegate to
their Clients sufficient power to act on their behalf via the EEP and
to ensure that their Clients have created an account in the LCH Portal
for use of the EEP (``Client Portal Account'') before delegating such
power.\8\ Finally, the proposed rule change would amend the Rule Book
to require Clients to exercise their delegated power only through their
Client Portal Account unless the EEP is or will be unavailable for the
exercise of CDS Options (an ``EEP Failure Event'').\9\
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    \6\ The proposed rule change would also apply these provisions
to FCM Clearing Members who clear credit-default swaps and CDS
Options for their Clients. Notice, 83 FR at 45156.
    \7\ Notice, 83 FR at 45158.
    \8\ Notice, 83 FR at 45156.
    \9\ Id.
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    The proposed rule change would add similar provisions to Appendix
VIII of the Supplement. Appendix VIII provides mandatory provisions
that are incorporated into transactions between a Clearing Member and
its Client. Changes to Appendix VIII are necessary to incorporate the
conditions described above directly into the terms of the transaction
between a Clearing Member and its Client. Specifically, the proposed
rule change would add new Section 5, which would provide that the
Clearing Member and its Client agree that the Clearing Member will
designate

its Client as its Exercise Delegation Beneficiary with respect to
Client Cleared Transactions.\10\ Moreover, new Section 5 would specify
the conditions upon which an Option Intent submitted by an Exercise
Delegation Beneficiary with respect to a Client Cleared Transaction
will be deemed a valid notice to exercise or abandon a CDS Option.\11\
Specifically, such an Option Intent will be deemed valid if (i) the
Client submits the Option Intent through its Client Portal Account;
(ii) the Option Intent is submitted prior to 4.00 p.m. (London time) on
the expiration date of the CDS Option; and (iii) LCH SA completes the
steps necessary to make the intent available for viewing in the EEP,
including validation of the EEP Controls (these controls are described
further below in subsection C as part of the technical specifications
of the EEP).\12\
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    \10\ Notice, 83 FR at 45161.
    \11\ Id.
    \12\ Notice, 83 FR at 45161. The proposed rule change would
define the term ``EEP Controls'' as the controls that LCH SA
performs immediately following the submission of an Option Intent.
These controls are described in Section 5 of the Procedures. If an
Option Intent does not pass these controls it is not made available
for viewing in the EEP by the Option Seller, and thus will not be
deemed a valid notice to exercise or abandon a CDS Option.
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    The proposed rule change would also limit LCH SA's liability
associated with Clients using the EEP to exercise their CDS Options.
The proposed rule change would amend the Rule Book to eliminate LCH
SA's liability for (i) any damage caused to a Clearing Member by its
Client exercising or not exercising a CDS Option in the EEP and (ii)
any improper use or disclosure by a third party, including a Client, of
information made available at the request of a Clearing Member.\13\ The
proposed rule change would add a new Section 13(b) to the Supplement to
eliminate LCH SA's liability to a Clearing Member for any cost or
expense arising out of any failure of an Exercise Delegation
Beneficiary to perform its obligations in relation with a delegation or
in connection with the exercise or abandonment of a CDS Option.\14\
Additionally, the proposed rule change would amend Section 13(d), which
currently provides that LCH SA will have no responsibility to verify
the contents of any notice received by it from any Clearing Member
under the terms of any Cleared Transaction.\15\ The proposed rule
change would amend Section 13(d) to clarify that this limitation on
responsibility also applies to any notice received from an Exercise
Delegation Beneficiary of a Clearing Member.
---------------------------------------------------------------------------

    \13\ Notice, 83 FR at 45156.
    \14\ Notice, 83 FR at 45160.
    \15\ Notice, 83 FR at 45160.
---------------------------------------------------------------------------

B. Operational Process for the Exercise of CDS Options in the EEP

    The proposed rule change would make a number of amendments to the
Rule Book and Supplement to further specify the operational process for
the exercise of CDS Options in the EEP.
    First, the proposed rule change would add defined terms to the Rule
Book and Supplement relevant to the creation and implementation of the
EEP.\16\ Moreover, the proposed rule change would amend existing
defined terms both to account for exercise of CDS Options through the
EEP and to correct typographical errors.\17\
---------------------------------------------------------------------------

    \16\ For an explanation of the definition of each of these
terms, see Notice, 83 FR at 45156-45157.
    \17\ Notice, 83 FR at 45156-45157.
---------------------------------------------------------------------------

    Second, the proposed rule change would make a number of
modifications and additions to Section 6 to provide for the operation
of the new EEP. The proposed rule change would facilitate the anonymous
exercise of CDS Options by removing the requirement that LCH SA notify
the CDS Option buyer and CDS Option seller of their respective
identifies.\18\ Instead, LCH SA would keep the identities and contact
information of the CDS Option buyer and CDS Option seller in a
protected report (the ``Protected Exercise Matched Pair Report''), and
it would provide access to this report only during an EEP Failure
Event, as discussed below.\19\
---------------------------------------------------------------------------

    \18\ Notice, 83 FR at 45157.
    \19\ The proposed rule change would add a new Section 5.8 to
Appendix VIII of the Supplement to require Clients to consent to the
disclosure of their address, fax number, telephone number, contact
email address (and any other applicable notice details) by their
Clearing Members to LCH SA and by LCH SA in any Protected Exercise
Matched Pair Report. Notice, 83 FR at 45162.
---------------------------------------------------------------------------

    The proposed rule change would also describe the circumstances in
which LCH SA would consider the exercise of a CDS Option via the EEP to
be valid in new Section 6.3. Specifically, the proposed rule change
would provide that an Option Intent is a valid notice to exercise or
abandon a CDS Option if the CDS Option buyer submits the Option Intent
prior to 4.00 p.m. (London time) and LCH SA has completed those steps
necessary to make such Option Intent available for viewing in the EEP,
including validation of the EEP Controls (discussed below).\20\
---------------------------------------------------------------------------

    \20\ Notice, 83 FR at 45157-45158.
---------------------------------------------------------------------------

    The proposed rule change would also provide procedures for exercise
of CDS Options during an EEP Failure Event.\21\ Specifically, new
Section 6.5 would require LCH SA to notify Clearing Members and their
Exercise Delegation Beneficiaries of the EEP Failure Event and the
subsequent resolution of the event.\22\ Following the occurrence of the
EEP Failure Event, Clearing Members (or their Exercise Delegation
Beneficiaries, as applicable) would be authorized to access the
information contained in the Protected Exercise Matched Pair Report
regarding the identity and contact information of the other Clearing
Member (or Exercise Delegation Beneficiary) within the matched
pair.\23\ During an EEP Failure Event, exercise or abandonment of CDS
Options would fall back to the existing manual delivery process using
the contact information from the Protected Exercise Matched Pair
Report. For an exercise or abandonment to be effective, a Clearing
Member (or its Exercise Delegation Beneficiary) would be required to
notify LCH SA of such exercise of abandonment by no later than 5.00
p.m. (Central European Time) on the expiration date of the CDS
Option.\24\
---------------------------------------------------------------------------

    \21\ The proposed rule change would also amend Appendix VIII of
the Supplement, regarding mandatory terms that are incorporated into
transactions between a Clearing Member and its Client, to add
provisions that mirror these procedures.
    \22\ Notice, 83 FR at 45158.
    \23\ Notice, 83 FR at 45158.
    \24\ Id.
---------------------------------------------------------------------------

    The proposed rule change would also address the circumstances under
which a CDS Option transaction will be terminated taking into account
implementation of the EEP. Specifically, the proposed rule change would
terminate a CDS Option where the CDS Option buyer elects to abandon the
CDS Option or fails to submit an Option Intent by the expiration date
of the CDS Option.\25\ Moreover, the proposed rule change would allow
LCH SA to terminate a CDS Option if the CDS Option buyer does not
submit an Option Intent by the expiration date of the CDS Option or if
there is an EEP Failure Event and LCH SA does not receive a notice of
exercise or abandonment by 5.00 p.m. (Central European Time) on the
expiration date.\26\
---------------------------------------------------------------------------

    \25\ Id.
    \26\ If there is an EEP Failure Event and LCH SA does not
receive a notice of exercise or abandonment by 5.00 p.m. (Central
European Time) on the expiration date, the proposed rule change
would provide that LCH may, in its sole discretion, give effect to
the terms of the notice if LCH determines that the notice was in
fact delivered and would have been effective. If LCH SA determines
that it is not possible to give effect to the terms of such notice,
then the relevant Clearing Members in a matched pair (or their
Exercise Delegation Beneficiaries, as applicable) would have rights
against each other for settlement payment as though parties to a
bilateral credit default swap transaction on the terms of the
relevant underlying index. Notice, 83 FR at 45158-45159.

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

    The proposed rule change would address situations where
communications failures at Clearing Members and their Clients prohibit
access to the EEP.\27\ Specifically, new Section 6.10 would provide
that if a Clearing Member or its Exercise Delegation Beneficiary
experiences a significant communications or information technology
failure resulting in it being impossible or impracticable to use EEP (a
``Clearing Member Communications Failure Event''), such Clearing Member
or its Exercise Delegation Beneficiary shall deliver notices to, and
receive notices from, LCH SA using the existing manual exercise
process.\28\ New Section 6.10 would further specify that upon receipt
of such notice, LCH SA will submit the notice to the EEP system for
processing by submitting an Option Intent in respect of such notice.
New Section 6.10 would further specify the conditions in which such a
notice would be deemed valid, including submission of the Option Intent
prior to 4.00 p.m. (London time) and LCH SA has completed those steps
necessary to make such Option Intent available for viewing in the EEP,
including validation of the EEP Controls (discussed below).\29\
---------------------------------------------------------------------------

    \27\ The proposed rule change would also amend Appendix VIII of
the Supplement, regarding mandatory terms that are incorporated into
transactions between a Clearing Member and its Client, to add
provisions that mirror these procedures. Notice, 83 FR at 45161.
    \28\ Notice, 83 FR at 45159.
    \29\ Id.
---------------------------------------------------------------------------

    New Section 6.10 would further require a Clearing Member or
Exercise Delegation Beneficiary affected by a Clearing Member
Communications Failure Event to notify LCH SA of the occurrence of the
communications failure event using the form notice set out in the
Appendix of the Supplement.\30\ Similarly, section 6.10 would require
an affected Clearing Member or Exercise Delegation Beneficiary to
notify LCH SA as soon as reasonably practicable when no longer subject
to a communications failure event, in which case the requirement to use
the EEP would resume.\31\
---------------------------------------------------------------------------

    \30\ Notice, 83 FR at 45159.
    \31\ Id.
---------------------------------------------------------------------------

    Finally, new Section 6.10(e) would require a Clearing Member or
Exercise Delegation Beneficiary subject to a Clearing Member
Communications Failure Event to use reasonable efforts to (i) mitigate
the operational impact on other Clearing Members and LCH SA of any such
event; (ii) cure such event as soon as reasonably practicable; and
(iii) ensure that the circumstances which caused such event do not
recur.\32\
---------------------------------------------------------------------------

    \32\ Notice, 83 FR at 45159.
---------------------------------------------------------------------------

    Third, the proposed rule change would also make various changes to
Section 8 of the Supplement regarding delivery of notices. The proposed
rule change would first amend Section 8.1(a) to make clear that Section
8.1(a) is subject to new Section 6.3.\33\ Section 8.1(a) provides
general conditions for the effectiveness of notices delivered in
respect of cleared transactions, and Section 6.3, as discussed above,
provides specific conditions for the effectiveness of notices delivered
via the EEP. The proposed rule change would next amend Section 8.1(b)
to implement certain conforming changes regarding notices from or to
LCH SA in the EEP, including with respect to the occurrence of an EEP
Failure Event.\34\ Additionally, the proposed rule change would amend
Section 8.1(c) to provide that notices shall be given to the name and
address provided in the Protected Exercise Matched Pair Report.\35\
---------------------------------------------------------------------------

    \33\ Notice, 83 FR at 45160.
    \34\ Id.
    \35\ Notice, 83 FR at 45160.
---------------------------------------------------------------------------

    The proposed rule change would also renumber Section 8.2 as new
Section 8.3. The proposed rule change would then delete the existing
Section 8.3 as well as the existing Section 8.4.\36\ Both of these
sections would no longer be applicable after the implementation of EEP.
The proposed rule change would renumber Section 8.5 as new Section 8.2
and make certain conforming changes to account for the delivery of the
Protected Exercise Matched Pair Report.\37\ The proposed rule change
would also describe the procedures to be used if LCH SA does not
provide the Protected Exercise Matched Pair Report. In such a case,
clearing members may deliver notices to exercise or abandon CDS Options
directly to LCH SA and vice versa.\38\
---------------------------------------------------------------------------

    \36\ Id.
    \37\ Id.
    \38\ Id.
---------------------------------------------------------------------------

    Fourth, the proposed rule change would add a new Appendix VI to
serve as the form to be used by a Clearing Member or Client to notify
LCH SA that it is subject to a Clearing Member Communications Failure
Event and a new Appendix VII to serve as the form to notify LCH SA that
it is no longer subject to such an event.\39\
---------------------------------------------------------------------------

    \39\ Id.
---------------------------------------------------------------------------

C. Technical Specifications of the EEP

    The technical specifications of the EEP would be set out in
amendments to Section 5 of the Procedures. Specifically, the proposed
rule change would add a definition of ``LCH Portal'' to Section 5.3(f).
``LCH Portal'' would be defined as a single sign-on solution for
various LCH SA applications to which Clearing Members may have access
over secured internet.\40\ The proposed rule change would revise
Section 5.16 to add a new paragraph entitling a Clearing Member to
request that all or part of the reports provided under Section 5.16 be
made available on the Client Portal Account.\41\
---------------------------------------------------------------------------

    \40\ Notice, 83 FR at 45162.
    \41\ Id.
---------------------------------------------------------------------------

    The proposed rule change would also amend Section 5.16(a)(i)(J) to
replace all references to ``Cleared Transaction Exercise Report'' with
``Protected Exercise Matched Pairs Report'' to reflect the new
reporting structure in EEP.\42\ The proposed rule change would further
specify the timing for ICEEU's preparation of the Protected Exercise
Matched Pairs Report and that such report will only be made accessible
following the occurrence of an EEP Failure Event.\43\
---------------------------------------------------------------------------

    \42\ Id.
    \43\ Id.
---------------------------------------------------------------------------

    The proposed rule change would delete the current Section
5.16(c)(ii), regarding reports of open interest in CDS Options, because
such a report would no longer be applicable after the proposed rule
change.\44\ The proposed rule change would renumber current Section
5.16(c)(iii) as a new Section 5.16(c)(ii) and current Section
5.16(c)(iv) as a new Section 5.16(c)(iii).
---------------------------------------------------------------------------

    \44\ Id.
---------------------------------------------------------------------------

    The proposed rule change would add a new Section 5.19 to require
Clearing Members to notify LCH SA when they delegate power to exercise
or abandon CDS Options to their Clients by sending a completed and
signed notification form to LCH SA via email.\45\
---------------------------------------------------------------------------

    \45\ Notice, 83 FR at 45162.
---------------------------------------------------------------------------

    The proposed rule change would add a new Section 5.19.2 to describe
the EEP Controls that LCH SA will use to determine that an Option
Intent is validly submitted. Specifically, upon a submission of an
Option Intent in the EEP, LCH SA will carry out logicality controls to
identify an intent which could have been submitted in the EEP in
error.\46\ The controls will be based on the relative position or the
price of the exercise compared to reference prices provided in the
EEP.\47\ LCH SA will not register in the EEP any intent which does not
pass such controls, and LCH SA will inform the applicable Clearing
Member or Exercise Delegation Beneficiary. The Clearing Member or

Exercise Delegation Beneficiary may then choose to re-submit such
intent or make a ``Force Submission.'' \48\ A Force Submission occurs
when the Clearing Member or its Exercise Delegation Beneficiary elects
to bypass the controls by specifying ``Confirm'' or ``Force'' when
submitting the Option Intent.\49\ LCH SA will not carry out controls on
such an Option Intent.\50\
---------------------------------------------------------------------------

    \46\ Id.
    \47\ Id.
    \48\ Id.
    \49\ Id.
    \50\ Id.
---------------------------------------------------------------------------

    New Section 5.19.2 would further specify that, before registering
any Option Intent, LCH SA will ensure that such intent (i) is submitted
by a user who (a) is connected with the proper user ID and password and
(b) based on such ID and password, is duly authorized to exercise or
abandon, as applicable, the relevant CDS Options; (ii) has not already
been submitted in the EEP (other than as a partial Exercise); and (iii)
passes the logicality controls or is a Force Submission.\51\
---------------------------------------------------------------------------

    \51\ Notice, 83 FR at 45162.
---------------------------------------------------------------------------

D. Other Changes

    The proposed rule change would make a number of other changes
related to CDS Options. First, the proposed rule change would make a
number of amendments regarding restructuring of CDS Options following a
credit event in respect of an entity referenced by the index underlying
the CDS Option.\52\ The proposed rule change would maintain the
existing manual notification process for transactions in restructured
CDS Options. To that end, the proposed rule change would delete a
number of provisions from Section 8 of the Supplement, which currently
contains the manual notification process, and reinstate them in Section
5, which sets out the procedures for restructured CDS Options.\53\
Similarly, the proposed rule change would make changes to Section 7 of
the Supplement regarding settlement of restructured CDS Options. The
proposed rule change would also amend Section 7.2 of the Supplement to
incorporate the term ``Auction Final Price Determination Date'' in
order to correct an inaccurate reference in the current version of the
Supplement.\54\ Additionally, the proposed rule change would amend
Section 7.3(b)(ii) of the Supplement to clarify that a valid Credit
Event Notice must be delivered or deemed to be delivered in respect for
subsections (x) and (y) of Section 7.3(b)(ii) to apply.\55\ Finally,
the proposed rule change would correct typographical errors in Sections
7.3 and 7.4(a) of the Supplement.\56\
---------------------------------------------------------------------------

    \52\ Notice, 83 FR at 45157.
    \53\ Id.
    \54\ Notice, 83 FR at 45160.
    \55\ Notice, 83 FR at 45160.
    \56\ Id.
---------------------------------------------------------------------------

    Second, the proposed rule change would update Section 9 of the
Supplement, regarding the creation of matched pairs. The proposed rule
change would delete Sections 9.1(c) and (d) to remove the requirement
that, to the extent possible, each matched pair of a CDS Option have an
amount which is an integral multiple of Euro 1,000,000 subject to a
maximum of Euro 100,000,000.\57\ Although this change is unrelated to
the implementation of EEP, LCH SA does not believe this condition is
necessary any longer, so the proposed rule change would update the
Supplement accordingly.
---------------------------------------------------------------------------

    \57\ Id.
---------------------------------------------------------------------------

    Finally, the proposed rule change would make typographical
corrections, update conforming references, and revise numbering
throughout the Rule Book, Supplement, and Procedures, as necessary.

III. Discussion and Commission Findings

    Section 19(b)(2)(C) of the Act directs the Commission to approve a
proposed rule change of a self-regulatory organization if it finds that
such proposed rule change is consistent with the requirements of the
Act and the rules and regulations thereunder applicable to such
organization.\58\ For the reasons given below, the Commission finds
that the proposed rule change is consistent with Section 17A(b)(3)(F)
of the Act \59\ and Rules 17Ad-22(e)(1), (e)(17)(i)-(ii), and (e)(18)
thereunder.\60\
---------------------------------------------------------------------------

    \58\ 15 U.S.C. 78s(b)(2)(C).
    \59\ 15 U.S.C. 78q-1(b)(3)(F).
    \60\ 17 CFR 240.17Ad-22(e)(1), (e)(17)(i)-(ii), and (e)(18).
---------------------------------------------------------------------------

A. Consistency With Section 17A(b)(3)(F) of the Act

    Section 17A(b)(3)(F) of the Act requires, among other things, that
the rules of LCH SA be designed to promote the prompt and accurate
clearance and settlement of securities transactions and, to the extent
applicable, derivative agreements, contracts, and transactions, as well
as to assure the safeguarding of securities and funds which are in the
custody or control of LCH SA or for which it is responsible, and, in
general, to protect investors and the public interest.\61\
---------------------------------------------------------------------------

    \61\ 15 U.S.C. 78q-1(b)(3)(F).
---------------------------------------------------------------------------

    The Commission believes that by eliminating the existing manual
notification process and replacing it with an electronic one, the EEP,
in general, would promote the efficient and effective exercise of CDS
Options. The EEP would eliminate the possible delays, errors, and
miscommunications that can result from manual notification via email.
In doing so, the Commission believes the EEP would promote the prompt
and accurate clearance and settlement of CDS Options transactions by
providing a means for the efficient exercise of CDS Options. Moreover,
in reducing the likelihood of delays, errors, and miscommunications as
compared to the existing manual notification process, the Commission
believes that the EEP would reduce the likelihood of disputes over the
exercise of CDS Options and the possibility that LCH SA may not
accurately capture a CDS Option buyer's intent to abandon or exercise a
CDS Option. In this regard, the Commission believes the EEP would help
assure the safeguarding of securities and funds relating to CDS Options
which are in the custody or control of LCH SA or for which it is
responsible by helping LCH SA to avoid disruptions to its operations
which could, in turn, impede access to securities and funds required in
connection with the exercise or abandonment of CDS Options. For both of
these reasons, the Commission also believes that the EEP, in general,
would protect investors and the public interest. Thus, the Commission
believes that the EEP, in general, would be consistent with Section
17A(b)(3)(F) of the Act.\62\
---------------------------------------------------------------------------

    \62\ 15 U.S.C. 78q-1(b)(3)(F).
---------------------------------------------------------------------------

    The Commission further believes that the specific aspects of the
proposed rule change that would facilitate the operation of the EEP
would also be consistent with Section 17A(b)(3)(F).\63\ Specifically,
the Commission believes that in (i) adding new defined terms (and
modifying existing defined terms accordingly); (ii) defining the
circumstances in which LCH SA would consider the exercise of a CDS
Option via the EEP to be valid; (iii) providing the circumstances in
which LCH SA would terminate a CDS Option; and (iv) establishing the
enforceability of notices delivered via the EEP, the proposed rule
change would provide the legal basis for operation of the EEP.
Similarly, by providing the technical specifications of the EEP
(including defining the applications and reports associated with the
EEP) and establishing the controls LCH SA would use to determine if an
Option Intent was submitted correctly and by an authorized user, the
Commission believes the proposed rule change would provide the
technological basis for operation of the EEP. The Commission believes
that these aspects of the proposed rule change would

thereby promote the use and operation of the EEP for executing CDS
Options transactions and therefore would promote the prompt and
accurate clearance and settlement of such transactions, consistent with
Section 17A(b)(3)(F).\64\
---------------------------------------------------------------------------

    \63\ 15 U.S.C. 78q-1(b)(3)(F).
    \64\ 15 U.S.C. 78q-1(b)(3)(F).
---------------------------------------------------------------------------

    Similarly, the Commission believes that the provisions of the
proposed rule change facilitating the exercise of CDS Options in the
EEP directly by Clients would promote the prompt and accurate clearance
and settlement of CDS Options. The Commission believes that if Clients
were not able to exercise their CDS Options directly in the EEP they
would have to rely on Clearing Members to do so on their behalf, which
would require communicating their intentions to Clearing Members
accurately and with sufficient time to allow Clearing Members to act
before expiration of the CDS Options. In contrast, allowing Clients to
exercise their CDS Options directly in the EEP should be more efficient
than, and avoid possible delays and miscommunications associated with,
Clearing Members exercising CDS Options on behalf of Clients. As a
result, the Commission believes the proposed rule change would promote
the prompt and accurate clearance and settlement of CDS Option
transactions by providing Clients a more efficient means for the
exercise of their CDS Options.
    Finally, the Commission believes that the other changes discussed
above are consistent with Section 17A(b)(3)(F) of the Act.\65\
Specifically, by consolidating provisions regarding delivery of notices
with provisions regarding restructuring of CDS Options and making other
updates regarding restructuring of CDS Options, the Commission believes
the proposed rule change would allow the existing notification process
for restructuring of CDS Options to continue after implementation of
the EEP. This would allow LCH SA to continue clearing and settling
restructured CDS Options outside of the EEP, thereby helping to promote
the prompt and accurate clearance and settlement of restructured CDS
Options. Moreover, the Commission believes that updating Section 9 of
the Supplement to remove the inapplicable provisions regarding the
creation of matched pairs would help ensure that LCH SA continues to
create matched pairs consistently, which is necessary to pair CDS
Option buyers and CDS Option sellers for purposes of executing or
abandoning CDS Options. The Commission therefore believes that these
aspects of the proposed rule change would promote the prompt and
accurate clearance and settlement of CDS Option transactions.
---------------------------------------------------------------------------

    \65\ 15 U.S.C. 78q-1(b)(3)(F).
---------------------------------------------------------------------------

    Therefore, for all of the above reasons the Commission finds that
the proposed rule change would promote the prompt and accurate
clearance and settlement of CDS Options transactions, assure the
safeguarding of securities and funds in LCH SA's custody and control,
and, in general, protect investors and the public interest, consistent
with the Section 17A(b)(3)(F) of the Act.\66\
---------------------------------------------------------------------------

    \66\ 15 U.S.C. 78q-1(b)(3)(F).
---------------------------------------------------------------------------

B. Consistency With Rule 17Ad-22(e)(1) of the Act

    Rule 17Ad-22(e)(1) requires that LCH SA establish, implement,
maintain and enforce written policies and procedures reasonably
designed to provide for a well-founded, clear, transparent, and
enforceable legal basis for each aspect of its activities in all
relevant jurisdictions.\67\
---------------------------------------------------------------------------

    \67\ 17 CFR 240.17Ad-22(e)(1).
---------------------------------------------------------------------------

    As discussed above, the Commission believes that the proposed rule
change would provide the legal basis for operation of the EEP by (i)
adding new defined terms (and modifying existing defined terms
accordingly); (ii) establishing the circumstances in which LCH SA would
consider the exercise of a CDS Option via the EEP to be valid; and
(iii) defining the circumstances in which LCH SA would terminate a CDS
Option. Moreover, the Commission believes the proposed rule change, in
making typographical corrections, updating conforming references, and
revising numbering throughout the Rule Book, Supplement, and
Procedures, would help ensure the consistency and accuracy of the Rule
Book, Supplement, and Procedures after implementation of the EEP,
thereby further helping to establish the legal basis for operation of
the EEP.
    Therefore, for the above reasons the Commission finds that the
proposed rule change is consistent with Rule 17Ad-22(e)(1).\68\
---------------------------------------------------------------------------

    \68\ 17 CFR 240.17Ad-22(e)(1).
---------------------------------------------------------------------------

C. Consistency With Rules 17Ad-22(e)(17)(i)-(ii) of the Act

    Rule 17Ad-22(e)(17)(i)-(ii) requires that LCH SA establish,
implement, maintain and enforce written policies and procedures
reasonably designed to manage its operational risks by identifying the
plausible sources of operational risk, both internal and external, and
mitigating their impact through the use of appropriate systems,
policies, procedures, and controls and ensuring that systems have a
high degree of security, resiliency, operational reliability, and
adequate, scalable capacity.\69\
---------------------------------------------------------------------------

    \69\ 17 CFR 240.17Ad-22(e)(17)(i), (ii).
---------------------------------------------------------------------------

    The Commission believes that, in replacing the existing manual
notification process, the EEP would reduce LCH SA's operational risks
associated with clearing and settling CDS Options. For example, the EEP
would check whether an Option Intent was erroneous based on the
relative position or the price in the Option Intent compared to
reference prices provided in the EEP. Such validity checks are not a
feature of the current notification process, and the Commission
believes that these checks would reduce the likelihood that an Option
Intent is submitted in error or otherwise miscommunicated. This, in
turn, would reduce the risk to LCH SA that it does not accurately
capture or execute a Clearing Member's or a Client's intent in
exercising or abandoning a CDS Option. Moreover, under the EEP, if a
CDS Option buyer submits an Option Intent before the exercise deadline
and it passes the EEP validation checks, the notice of exercise or
abandonment would be deemed legally delivered by LCH SA to the CDS
Option seller on a real time basis. The Commission believes that this
feature of the EEP would help reduce the possibility that LCH SA could
fail to carry out a Clearing Member's or a Client's intent in
exercising a CDS Option, further reducing LCH SA's operational risks in
clearing and settling CDS Option transactions.
    The proposed rule change would establish procedures for the
exercise of CDS Options in the case of the EEP not being operational or
a Clearing Member or Client being unable to access the EEP due to a
Clearing Member Communications Failure Event. In addition, the proposed
rule change would require Clearing Members and Clients to (i) mitigate
the impact of a Clearing Member Communications Failure Event; (ii) cure
such event as soon as reasonably practicable; and (iii) ensure that the
circumstances which caused such event do not recur. The Commission
believes that these procedures, which would fall back on the existing
manual notification process in place of the EEP, would provide a
reasonable alternative in circumstances where the EEP is unavailable or
inaccessible. The Commission further believes that these procedures, in
providing another means to exercise CDS Options, would help mitigate
the impact to Clearing Members and Clients from a malfunction of the
EEP or a

communications failure. Thus, the Commission believes that these
alternative procedures would help ensure the resiliency and operational
reliability of the EEP by providing a means to exercise CDS Options
where the EEP is unavailable or inaccessible.
    Therefore, for the above reasons the Commission finds that the
proposed rule change is consistent with Rules 17Ad-22(e)(17)(i)-
(ii).\70\
---------------------------------------------------------------------------

    \70\ 17 CFR 240.17Ad-22(e)(17)(i)-(ii).
---------------------------------------------------------------------------

D. Consistency With Rule 17Ad-22(e)(18)

    Rule 17Ad-22(e)(18) requires that LCH SA establish, implement,
maintain and enforce written policies and procedures reasonably
designed to establish objective, risk-based, and publicly disclosed
criteria for participation, which permit fair and open access by direct
and, where relevant, indirect participants and other financial market
utilities, require participants to have sufficient financial resources
and robust operational capacity to meet obligations arising from
participation in the clearing agency, and monitor compliance with such
participation requirements on an ongoing basis.\71\
---------------------------------------------------------------------------

    \71\ 17 CFR 240.17Ad-22(e)(18).
---------------------------------------------------------------------------

    The Commission believes that by allowing Clients to exercise CDS
Options in the EEP directly, the proposed rule change would establish
objective and publicly disclosed criteria for Clients to participate in
the EEP. Specifically, the proposed rule change would, as discussed
above, require Clearing Members to designate their relevant Clients to
act on their behalf via the EEP with respect to those CDS Options
transactions that are Client Cleared Transactions. The proposed rule
change would also require that Clearing Members delegate to their
Clients sufficient power to act on their behalf via the EEP and require
Clients to exercise that power through their Client Portal Account on
the EEP. Finally, the proposed rule change would add provisions to
Appendix VIII of the Supplement to incorporate these conditions
directly into the terms of the transaction between a Clearing Member
and its Client. The Commission believes that these aspects of the
proposed rule change would establish the objective and public criteria
that Clients must follow to directly access the EEP and participate in
exercising CDS Options at LCH SA. Moreover, the Commission believes
these aspects of the proposed rule change would permit fair and open
access by Clients by requiring Clearing Members to designate their
relevant Clients to act on their behalf in exercising their CDS
Options.
    Therefore, for the above reasons the Commission finds that the
proposed rule change is consistent with Rule 17Ad-22(e)(18).\72\
---------------------------------------------------------------------------

    \72\ 17 CFR 240.17Ad-22(e)(18).
---------------------------------------------------------------------------

IV. Conclusion

    On the basis of the foregoing, the Commission finds that the
proposed rule change is consistent with the requirements of the Act,
and in particular, Section 17A(b)(3)(F) of the Act \73\ and Rules 17Ad-
22(e)(1), (e)(17)(i)-(ii), and (e)(18) thereunder.\74\
---------------------------------------------------------------------------

    \73\ 15 U.S.C. 78q-1(b)(3)(F).
    \74\ 17 CFR 240.17Ad-22(e)(1), (e)(17)(i)-(ii), (e)(18).
---------------------------------------------------------------------------

    It is therefore ordered pursuant to Section 19(b)(2) of the Act
that the proposed rule change (SR-LCH SA-2018-004) be, and hereby is,
approved.\75\
---------------------------------------------------------------------------

    \75\ In approving the proposed rule change, the Commission
considered the proposal's impacts on efficiency, competition, and
capital formation. 15 U.S.C. 78c(f).

    For the Commission by the Division of Trading and Markets,
pursuant to delegated authority.\76\
Eduardo A. Aleman,
Assistant Secretary.
---------------------------------------------------------------------------

    \76\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

[FR Doc. 2018-22540 Filed 10-16-18; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 76, Number 175 (Friday, September 9, 2011)]
[Notices]
[Pages 55923-55927]
[FR Doc No: 2011-23099]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0480]

Draft Guidance for Industry: Submission of Warning Plans for
Cigarettes and Smokeless Tobacco Products; Availability; Agency
Information Collection Activities; Proposed Collection; Comment Request

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance for industry entitled ``Submission of
Warning Plans for Cigarettes and Smokeless Tobacco Products.'' This
draft guidance document is intended to assist persons submitting
warning plans to FDA under the Comprehensive Smokeless Tobacco Health
Education Act, as amended by the Family Smoking Prevention and Tobacco
Control Act; and under the Federal Cigarette Labeling and Advertising
Act, as amended by the Family Smoking Prevention and Tobacco Control
Act, when that requirement takes effect.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by November 8, 2011.
    Submit either electronic or written comments on the proposed
collection of information by November 8, 2011.

ADDRESSES: Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments, including comments
regarding the proposed collection of information, to the Division of
Dockets Management (HFA-305), Food and Drug

Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    Submit written requests for single copies of the draft guidance
document entitled ``Submission of Warning Plans for Cigarettes and
Smokeless Tobacco Products'' to the Center for Tobacco Products, Food
and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850-
3229. Send one self-addressed adhesive label to assist that office in
processing your request or include a fax number to which the draft
guidance may be sent. See the SUPPLEMENTARY INFORMATION section for
electronic access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT:
    With regard to the draft guidance: Gail Schmerfeld, Center for
Tobacco Products, Food and Drug Administration, 9200 Corporate Blvd.,
Rockville, MD 20850-3229, 1-877-287-1373<EMAIL_ADDRESS>    With regard to the proposed collection of information: Jonna
Capezzuto, Office of Information Management, Food and Drug
Administration, 1350 Piccard Dr., P150-400B, Rockville, MD 20850, 301-
796-3794<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of the draft guidance entitled
``Submission of Warning Plans for Cigarettes and Smokeless Tobacco
Products.'' This guidance, when finalized, will provide industry with
information on how to submit warning plans for smokeless tobacco
products under section 3 of the Comprehensive Smokeless Tobacco Health
Education Act of 1986 (Smokeless Tobacco Act) and warning plans for
cigarettes under section 4 of the Federal Cigarette Labeling and
Advertising Act (FCLAA) when that requirement takes effect.
    On June 22, 2009, the President signed the Family Smoking
Prevention and Tobacco Control Act (Tobacco Control Act) (Pub. L. 111-
31) into law. The Tobacco Control Act grants FDA authority to regulate
the manufacture, marketing, and distribution of tobacco products to
protect public health generally and to reduce tobacco use by minors.
Section 201 of the Tobacco Control Act amended section 4 of FCLAA (15
U.S.C. 1333). When it takes effect, section 4 of FCLAA will require the
submission of warning plans for cigarette packaging and advertising to
FDA. Section 204 of the Tobacco Control Act amended section 3 of the
Smokeless Tobacco Act (15 U.S.C. 4402), requiring the submission of
warning plans for smokeless tobacco product packaging and advertising
to FDA. The warning plans must be submitted by the tobacco product
manufacturer, importer, distributor, or retailer, be approved by FDA,
and provide for the random display of specified health warnings on
packages and quarterly rotation of those health warnings in
advertisements.
    This draft guidance is intended to assist persons submitting
warning plans for cigarettes and for smokeless tobacco products. The
guidance discusses, among other things: The statutory requirement to
submit a warning plan; definitions; who submits a warning plan; the
scope of a warning plan; when to submit a warning plan; what
information to include in a warning plan; where to submit; and what
approval of a warning plan means.

II. Significance of Guidance

    FDA is issuing this draft guidance document consistent with FDA's
good guidance practices regulations (21 CFR 10.115). The draft
guidance, when finalized, will represent the Agency's current thinking
on ``Submission of Warning Plans for Cigarettes and Smokeless Tobacco
Products.'' It does not create or confer any rights for or on any
person and does not operate to bind FDA or the public. An alternative
approach may be used if such approach satisfies the requirements of the
applicable statute and regulations.

III. Paperwork Reduction Act of 1995

    Under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501-3520),
Federal Agencies must obtain approval from the Office of Management and
Budget (OMB) for each collection of information they conduct or
sponsor. ``Collection of information'' is defined in 44 U.S.C. 3502(3)
and 5 CFR 1320.3(c) and includes Agency requests or requirements that
members of the public submit reports, keep records, or provide
information to a third party. Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day
notice in the Federal Register concerning each proposed collection of
information before submitting the collection to OMB for approval. To
comply with this requirement, FDA is publishing notice of the proposed
collection of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Draft Guidance for Industry: Submission of Warning Plans for Cigarettes
and Smokeless Tobacco Products (OMB Control Number 0910--New)
    This draft guidance is intended to assist persons submitting
warning plans for smokeless tobacco products under section 3 of the
Smokeless Tobacco Act and for cigarettes under section 4 of FCLAA, when
that requirement takes effect. The guidance document discusses, among
other things: The statutory requirement to submit a warning plan;
definitions; who submits a warning plan; the scope of a warning plan;
when to submit a warning plan; what information should be submitted in
a warning plan; where to submit a warning plan; and what approval of a
warning plan means. FDA may collect statutorily mandated warning plan
information for smokeless tobacco products under OMB control number
0910-0671. The purpose of the proposed information collection is to
allow FDA to collect statutorily mandated information regarding warning
plans for cigarettes and administrative information related to warning
plans for both cigarettes and smokeless tobacco products.
    Section 4 of FCLAA states that each cigarette package and
advertisement must bear one of nine health warning statements and
requires the submission of warning plans for cigarette packages and
advertisements to FDA for review and approval. These requirements are
currently not in effect. Section 4(d) of FCLAA (15 U.S.C. 1333(d))
requires FDA to issue regulations that require color graphics depicting
the negative health consequences of smoking to accompany those warning
statements. Section 201(b) of the Tobacco Control Act states that the
requirements take effect 15 months after FDA issues these regulations.
Under the provision, however, if a cigarette product was manufactured
prior to the effective date of the final rule but its package does not
contain a required warning, the product may be introduced into commerce
in the United States within 30 days from such effective date. After the
30-day period,

manufacturers must not introduce into domestic commerce any cigarette
the package of which does not contain a required warning (i.e., a
textual warning statement and accompanying graphic), irrespective of
the date of manufacture. FDA published a proposed rule regarding these
requirements on November 12, 2010 (see 75 FR 69524). FDA published the
final rule on June 22, 2011 (see 76 FR 36628). This rule is effective
September 22, 2012.

A. Warning Plans for Cigarettes

    The requirement for submission of warning plans for cigarettes, and
the specific requirements relating to the random display of required
warnings on cigarette packaging and quarterly rotation of required
warnings in cigarette advertising, appear at 15 U.S.C. 1333(c). In
particular, warning plans for cigarette packaging must provide that all
of the required warnings are randomly displayed in each 12-month period
on each brand of the product; are randomly displayed in as equal a
number of times as is possible on each brand of the product; and are
randomly distributed in all areas of the United States in which the
product is marketed. For FDA to approve it, a warning plan must provide
for the required equal distribution and display of required warnings on
packaging and must assure that all of the required warnings will be
displayed by the manufacturer, importer, distributor, or retailer at
the same time.
    For FDA to approve it, a warning plan for cigarette advertising
must provide that all of the required warnings are rotated quarterly in
alternating sequence in advertisements for each brand of cigarettes.
    Section 3 of the Smokeless Tobacco Act states that each smokeless
tobacco product package and advertisement must bear one of four
required warning statements and requires the submission of warning
plans for smokeless tobacco product packages and advertisements to FDA
for review and approval. The requirement for an FDA approved warning
plan became effective June 22, 2010. On June 8, 2010, FDA announced by
guidance its intent not to enforce the requirement that a brand of
smokeless tobacco product must have an FDA-approved warning plan so
long as a warning plan for the brand was submitted to FDA by July 22,
2010, and implemented (see 75 FR 32481). FDA expects to begin enforcing
the requirement under Section 3 that there be an approved warning plan
6 months after the publication of the notice of availability of a final
guidance on the ``Submission of Warning Plans for Cigarettes and
Smokeless Tobacco Products'' or 6 months after the publication of a
final regulation regarding the submission of warning plans, whichever
comes first.

B. Warning Plans for Smokeless Tobacco Products

    The requirement for submission of warning plans for smokeless
tobacco products, and the specific requirements relating to the random
display of required warning statements on smokeless tobacco packaging
and quarterly rotation of required warning statements in smokeless
tobacco product advertising, appear at 15 U.S.C. 4402(b)(3). In
particular, warning plans for smokeless tobacco product packaging must
provide that all of the required warnings are randomly displayed in
each 12-month period on each brand of the product; are randomly
displayed in as equal a number of times as is possible on each brand of
the product; and are randomly distributed in all areas of the United
States in which the product is marketed. For FDA to approve it, a
warning plan must provide for the required equal distribution and
display of required warning statements on packaging and must assure
that all of the required warning statements will be displayed by the
manufacturer, importer, distributor, or retailer at the same time.
    Warning plans for smokeless tobacco product advertising must
provide that all of the required warning statements are rotated
quarterly in alternating sequence in advertisements for each brand of
smokeless tobacco product.
    In an important change from prior law, outdoor billboard
advertising for smokeless tobacco products must now include the
required warning statements. Prior to its amendment by the Tobacco
Control Act, the Smokeless Tobacco Act exempted outdoor billboard
advertising from the requirement that smokeless tobacco product
advertisements bear required warning statements, but the Tobacco
Control Act amendments eliminated this exemption (which had been
codified at 15 U.S.C. 4402(a)(2)). Thus, it is unlawful for any
smokeless tobacco product manufacturer, packager, importer,
distributor, or retailer to advertise or cause to be advertised within
the United States a smokeless tobacco product on an outdoor billboard
unless the advertisement bears one of the required warning statements.
    Because section 9(1) of the Smokeless Tobacco Act, 15 U.S.C.
4408(1) (as amended by section 101(c) of the Tobacco Control Act),
defines ``smokeless tobacco,'' by reference to section 900(18) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 387(18)), as ``any
tobacco product that consists of cut, ground, powdered, or leaf tobacco
and that is intended to be placed in the oral or nasal cavity,''
smokeless tobacco products intended to be placed in the nasal cavity
must now comply with the warning requirements in section 3 of the
Smokeless Tobacco Act. At this time, as an exercise of enforcement
discretion, FDA does not intend to commence or recommend enforcement of
the requirement that smokeless tobacco products marketed solely for use
in the nasal cavity bear either the ``WARNING: This product can cause
mouth cancer'' or the ``WARNING: This product can cause gum disease and
tooth loss'' so long as a warning plan providing that packages and
advertising for such products will bear the other two warnings has been
submitted to FDA and implemented. FDA will give further consideration
to the warnings smokeless tobacco products marketed solely for use in
the nasal cavity should bear. FDA intends to provide further public
notice prior to revising or rescinding this enforcement policy.

C. Description of Respondents

    The respondents to this collection of information are
manufacturers, importers, distributors, and retailers of cigarettes
and/or smokeless tobacco products who are required to submit warning
plans for cigarettes and smokeless tobacco products to FDA under FCLAA
and the Smokeless Tobacco Act.
    FDA estimates the burden of this collection of information as
follows:

                                Table 1--Cigarette Warning Plans Reporting Burden
                                         [New Collection of Information]
----------------------------------------------------------------------------------------------------------------
                                                                     Number of       Hours per     Total burden
                 Respondent by type of document                     respondents      response          hours
----------------------------------------------------------------------------------------------------------------
                                                  Cover Letter
----------------------------------------------------------------------------------------------------------------
Manufacturers, Distributors, and Importers......................             226               5           1,130
Retailers.......................................................             544               5           2,720
Total Cover Letters.............................................             770  ..............           3,850
----------------------------------------------------------------------------------------------------------------
                                                  Warning Plan
----------------------------------------------------------------------------------------------------------------
Manufacturers, Distributors, and Importers......................             226             120          27,120
Retailers.......................................................             544             120          65,280
Total Warning Plans.............................................             770  ..............          92,400
Total Burden Hours..............................................  ..............  ..............          96,250
----------------------------------------------------------------------------------------------------------------

                        Table 2--Smokeless Tobacco Product Warning Plans Reporting Burden
                           [New Cover Letter Plus Existing Collection of Information]
----------------------------------------------------------------------------------------------------------------
                                                                     Number of       Hours per     Total burden
                 Respondent by type of document                     respondents      response          hours
----------------------------------------------------------------------------------------------------------------
                                                  Cover Letter
----------------------------------------------------------------------------------------------------------------
Manufacturers, Distributors, and Importers......................              20               5             100
Retailers.......................................................              10               5              50
Total Cover Letters.............................................              30  ..............             150
----------------------------------------------------------------------------------------------------------------
                                                  Warning Plan
----------------------------------------------------------------------------------------------------------------
Manufacturers, Distributors, and Importers *....................  ..............  ..............  ..............
Retailers.......................................................              10             120           1,200
Total Warning Plans *...........................................              10  ..............           1,200
Total Burden Hours..............................................  ..............  ..............           1,350
----------------------------------------------------------------------------------------------------------------
* The burden for collection of the warning plans for Smokeless Tobacco Products from manufacturers,
  distributors, and importers is approved and covered under OMB control number 0910-0671.

    FDA's estimate of the number of respondents in table 1 of this
Federal Register document is based on the number of warning plans for
cigarettes submitted to the Federal Trade Commission prior to the
implementation of the Tobacco Control Act on June 22, 2009, which
grants FDA authority to regulate the manufacture, marketing, and
distribution of tobacco products to protect public health generally and
to reduce tobacco use by minors. Using data from 34 State retailer
lists, FDA identified 544 cigarette retailers who have 20 or more
locations, and thus, may be more likely than smaller retailers to
create their own advertisements and submit warning plans to FDA for
those advertisements.
    Thus, FDA estimates the number of manufacturers, importers,
distributors, and retailers who are expected to submit warning plans
for cigarette products in table 1 of this Federal Register document to
be 770. Based on its experience, FDA estimates it may take between 2
and 8 hours to prepare and submit a cover letter, depending on the
number of products and brands submitted. FDA estimates it could take 2
to 3 days for a person in a smaller firm to prepare warning plans, and
up to a week for a person in a larger firm, depending on the number of
products and brands submitted.
    The burden hours for the preparation and submission of warning
plans by manufacturers, distributors, and importers for smokeless
tobacco products in table 2 of this document have already been approved
by OMB under OMB control number 0910-0671. Based on plans submitted to
FDA to date, we estimate the number of retailers who will submit
warning plans for smokeless tobacco products to be 10. FDA estimates
the burden hours for retailers to prepare warning plans to be 1,200.
FDA estimates the additional burden hours for preparation of the cover
letter is 150 hours (100 burden hours for manufacturers, distributors,
and importers and 50 burden hours for retailers).
    FDA estimates, therefore, that it will take an average of 5 hours
to prepare and submit a cover letter and 120 hours to prepare and
submit a warning plan for packaging and advertising. The total number
of burden hours are estimated to be 1,350 hours ([150 cover letter
burden hours] + [1,200 warning plan burden hours].)

IV. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding this
document. It is only necessary to send one set of comments. It is no
longer necessary to send two copies of mailed comments. Identify
comments with the docket number found in brackets in the heading of
this document. Received comments may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.

V. Electronic Access

    Persons with access to the Internet may obtain an electronic
version of this draft guidance document at either http://www.regulations.gov or http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/default.htm.

    Dated: September 2, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-23099 Filed 9-8-11; 8:45 am]
BILLING CODE 4160-01-P


From:	Bacon, Leigh<EMAIL_ADDRESS>Sent:	Thursday, February 2, 2017 9:05 AM
To:	Walther, Katherine
Subject:	FW: Competing Source Inventory for the DRR
Attachments:	GastonDRR525.xlsx

From: Bacon, Leigh
Sent: Wednesday, May 25, 2016 1:47 PM
To: Bacon, Leigh
Subject: FW: Competing Source Inventory for the DRR

From: Bacon, Leigh
Sent: Wednesday, May 25, 2016 1:47 PM
To: 'Steele, C. Mark'
Cc: Carlson, James; Brown, Larry; Graham, Amy
Subject: Competing Source Inventory for the DRR

Mr. Steele,
Please find enclosed a model ready inventory for the area surrounding the Gaston Steam Plant in
Wilsonville, Alabama.  This inventory represents a starting point for further evaluation, as decided by the
facility, to meet the requirements of EPA’s 1 hour SO2 Data Requirements Rule (DRR).  The basis for the
inventory was the use of the following metric in culling facilities, then an evaluation of the emissions
units at the remaining facilities on a unit by unit basis.  This process is laid out below for your
information.  Please let me know if you have any questions about the inventory.  Otherwise, have a
great afternoon.

ADEM Metric:     Q/D > 20 within 20km
*	First, ALL sources within 20km of YOUR facility were pulled,
*	Next, a Q/D value was developed for each facility on the list, where Q represents the SO2 tpy
emissions totals, and D represents the distance between the two facilities,
*	If the Q/D metric yielded a value of greater than 20, the facility was retained and additional
QA/QC was performed on a unit by unit basis.

The results of this process are included in the spreadsheet attached. Again, please feel free to contact
me with questions.

Thank you,

Leigh

Leigh Barb Bacon
State of AL- DEM
p-<PHONE_NUMBER>


[Federal Register Volume 80, Number 101 (Wednesday, May 27, 2015)]
[Notices]
[Pages 30229-30230]
[FR Doc No: 2015-12708]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 14663-000]

Arkansas Electric Cooperative Corporation; Notice of Preliminary
Permit Application Accepted for Filing and Soliciting Comments, Motions
To Intervene, and Competing Applications

    On March 3, 2015, Arkansas Electric Cooperative Corporation, filed
an application for a preliminary permit, pursuant to section 4(f) of
the Federal Power Act (FPA), proposing to study the feasibility of a
hydropower project to be located at the U.S. Army Corps of Engineers'
(Corps) Joe Hardin Lock and Dam #3 on the Arkansas River near the towns
of Pine Bluff and Grady in Jefferson and Lincoln Counties, Arkansas.
The sole purpose of a preliminary permit, if issued, is to grant the
permit holder priority to file a license application during the permit
term. A preliminary permit does not authorize the permit holder to
perform any land-disturbing activities or otherwise enter upon lands or
waters

owned by others without the owners' express permission.
    The proposed project would consist of the following: (1) A 800-
foot-long, 400-foot-wide intake channel; (2) a 200-foot-long, 210-foot-
wide powerhouse containing four generating units with a total capacity
of 48 megawatts; (3) a 1,300-foot-long, 500-foot-wide tailrace; (4) a
6.9/115 kilo-Volt (kV) substation; and (5) a 5-mile-long, 115kV
transmission line. The proposed project would have an estimated average
annual generation of 155,000 megawatt-hours, and operate as directed by
the Corps.
    Applicant Contact: Mr. Jonathan Oliver, Arkansas Electric
Cooperative Corporation, One Cooperative Way, Little Rock, AR 72209;
Phone:<PHONE_NUMBER>; Email<EMAIL_ADDRESS>    FERC Contact: Christiane Casey<EMAIL_ADDRESS>(202)
502-8577.
    Deadline for filing comments, motions to intervene, competing
applications (without notices of intent), or notices of intent to file
competing applications: 60 days from the issuance of this notice.
Competing applications and notices of intent must meet the requirements
of 18 CFR 4.36. Comments, motions to intervene, notices of intent, and
competing applications may be filed electronically via the Internet.
See 18 CFR 385.2001(a)(1)(iii) and the instructions on the Commission's
Web site http://www.ferc.gov/docs-filing/efiling.asp. Commenters can
submit brief comments up to 6,000 characters, without prior
registration, using the eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You must include your name and contact information
at the end of your comments. For assistance, please contact FERC Online
Support at<EMAIL_ADDRESS>or toll free at 1-866-208-3676,
or for TTY,<PHONE_NUMBER>. Although the Commission strongly encourages
electronic filing, documents may also be paper-filed. To paper-file,
mail an original and five copies to: Kimberly D. Bose, Secretary,
Federal Energy Regulatory Commission, 888 First Street NE., Washington,
DC 20426. The first page of any filing should include docket number P-
14663-000.
    More information about this project, including a copy of the
application, can be viewed or printed on the ``eLibrary'' link of
Commission's Web site at http://www.ferc.gov/docs-filing/elibrary.asp.
Enter the docket number (P-14663) in the docket number field to access
the document. For assistance, contact FERC Online Support.

    Dated: May 20, 2015.
 Kimberly D. Bose,
 Secretary.
[FR Doc. 2015-12708 Filed 5-26-15; 8:45 am]
 BILLING CODE 6717-01-P