[Federal Register: August 14, 2009 (Volume 74, Number 156)]
[Notices]
[Page 41144-41145]
[DOCID:fr14au09-56]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0343]

International Conference on Harmonisation; Draft Guidance on Q4B
Evaluation and Recommendation of Pharmacopoeial Texts for Use in the
International Conference on Harmonisation Regions; Annex 9 on Tablet
Friability General Chapter; Availability

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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SUMMARY:  The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance entitled ``Q4B Evaluation and
Recommendation of Pharmacopoeial Texts for Use in the ICH Regions;
Annex 9: Tablet Friability General Chapter.'' The draft guidance was
prepared under the auspices of the International Conference on
Harmonisation of Technical Requirements for Registration of
Pharmaceuticals for Human Use (ICH). The draft guidance provides the
results of the ICH Q4B evaluation of the Tablet Friability General
Chapter harmonized text from each of the three pharmacopoeias (United
States, European, and Japanese) represented by the Pharmacopoeial
Discussion Group (PDG). The draft guidance conveys recognition of the
three pharmacopoeial methods by the three ICH regulatory regions and
provides specific information regarding the recognition. The draft
guidance is intended to recognize the interchangeability between the
local regional pharmacopoeias, thus avoiding redundant testing in favor
of a common testing strategy in each regulatory region. This draft
guidance is the ninth annex to the core Q4B guidance, which was made
available in the Federal Register of February 21, 2008 (73 FR 9575).

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this draft guidance before it begins work on the final version of the
guidance, submit written or electronic comments on the draft guidance
by October 13, 2009.

ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information (HFD-240), Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD 20993-0002; or
the Office of Communication and Development, Center for Biologics
Evaluation and Research, Food and Drug Administration, 1401 Rockville
Pike, suite 200N, Rockville, MD 20852-1448. The guidance may also be
obtained by mail by calling the Center for Biologics Evaluation and
Research at 1-800-835-4709 or<PHONE_NUMBER>. Send two self-addressed
adhesive labels to assist the office in processing your requests.
Submit written comments on the draft guidance to the Division of
Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments
to http://www.regulations.gov. See the SUPPLEMENTARY INFORMATION
section for electronic access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT:
    Regarding the guidance: Robert H. King, Sr., Center for Drug
Evaluation and Research (HFD-003), Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 51, rm. 4150, Silver Spring, MD 20993-0002,
301-796-1242; or
     Christopher Joneckis, Center for Biologics Evaluation and Research
(HFM-25), Food and Drug Administration, 1401 Rockville Pike, suite
200N, Rockville, MD 20852-1448,<PHONE_NUMBER>.
    Regarding the ICH: Michelle Limoli, Office of International
Programs (HFG-1), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    In recent years, many important initiatives have been undertaken by
regulatory authorities and industry associations to promote
international harmonization of regulatory requirements. FDA has
participated in many meetings designed to enhance

harmonization and is committed to seeking scientifically based
harmonized technical procedures for pharmaceutical development. One of
the goals of harmonization is to identify and then reduce differences
in technical requirements for drug development among regulatory
agencies.
    ICH was organized to provide an opportunity for tripartite
harmonization initiatives to be developed with input from both
regulatory and industry representatives. FDA also seeks input from
consumer representatives and others. ICH is concerned with
harmonization of technical requirements for the registration of
pharmaceutical products among three regions: The European Union, Japan,
and the United States. The six ICH sponsors are the European
Commission; the European Federation of Pharmaceutical Industries
Associations; the Japanese Ministry of Health, Labour, and Welfare; the
Japanese Pharmaceutical Manufacturers Association; the Centers for Drug
Evaluation and Research and Biologics Evaluation and Research, FDA; and
the Pharmaceutical Research and Manufacturers of America. The ICH
Secretariat, which coordinates the preparation of documentation, is
provided by the International Federation of Pharmaceutical
Manufacturers Associations (IFPMA).
    The ICH Steering Committee includes representatives from each of
the ICH sponsors and the IFPMA, as well as observers from the World
Health Organization, Health Canada, and the European Free Trade Area.
    In June 2009, the ICH Steering Committee agreed that a draft
guidance entitled ``Q4B Evaluation and Recommendation of Pharmacopoeial
Texts for Use in the ICH Regions; Annex 9: Tablet Friability General
Chapter'' should be made available for public comment. The draft
guidance is the product of the Q4B Expert Working Group of the ICH.
Comments about this draft will be considered by FDA and the Q4B Expert
Working Group.
    The draft guidance provides the specific evaluation results from
the ICH Q4B process for the Tablet Friability General Chapter
harmonization proposal originating from the three-party PDG. This draft
guidance is in the form of an annex to the core ICH Q4B guidance. Once
finalized, the annex will provide guidance to assist industry and
regulators in the implementation of the specific topic evaluated by the
ICH Q4B process.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the agency's current thinking on this topic.
It does not create or confer any rights for or on any person and does
not operate to bind FDA or the public. An alternative approach may be
used if such approach satisfies the requirements of the applicable
statutes and regulations.

II. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments on the draft guidance.
Submit a single copy of electronic comments or two paper copies of any
mailed comments, except that individuals may submit one paper copy.
Comments are to be identified 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.

III. Electronic Access

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

    Dated: July 31, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-19528 Filed 8-13-09; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register Volume 88, Number 119 (Thursday, June 22, 2023)]
[Notices]
[Pages 40890-40893]
[FR Doc No: 2023-13211]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-97737; File No. SR-ICEEU-2023-014]

Self-Regulatory Organizations; ICE Clear Europe Limited; Notice
of Filing and Immediate Effectiveness of Proposed Rule Change Relating
to Amendments to the Futures and Options Default Management Procedures

June 15, 2023.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on June 6, 2023, ICE Clear Europe Limited (``ICE Clear Europe'' or the
``Clearing House'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule changes described in Items I, II and
III below, which Items have been prepared by ICE Clear Europe. ICE
Clear Europe filed the proposed rule change pursuant to Section
19(b)(3)(A) of the Act \3\ and Rule 19b-4(f)(4)(ii) thereunder,\4\ such
that the proposed rule change was immediately effective upon filing
with the Commission. The Commission is publishing this notice to
solicit comments on the proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A).
    \4\ 17 CFR 240.19b-4(f)(4)(ii).
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I. Clearing Agency's Statement of the Terms of Substance of the
Proposed Rule Change

    ICE Clear Europe Limited (``ICE Clear Europe'' or the ``Clearing
House'') is proposing to adopt new Futures and Options Default
Management Procedures (the ``Procedures'').\5\ The new Procedures are
intended to supplement the Clearing House's existing Futures and
Options Default Management Policy by describing in further detail the
actions the Clearing House may take in the event of a Clearing Member
default.
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    \5\ Capitalized terms used but not defined herein have the
meanings specified in the ICE Clear Europe Clearing Rules and the
Procedures.
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II. Clearing Agency's Statement of the Purpose of, and Statutory Basis
for, the Proposed Rule Change

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

(A) Clearing Agency's Statement of the Purpose of, and Statutory Basis
for, the Proposed Rule Change

(a) Purpose
    ICE Clear Europe is proposing to adopt new Futures and Options
Default Management Procedures, which would supplement the Clearing
House's existing F&O Default Management Policy (the ``Default
Management Policy'') and describe in further detail the actions the
Clearing House will take if an Event of Default is declared in relation
to an F&O Clearing Member. The Procedures are generally intended to
document, in a consolidated way, the Clearing House's current practices
around default management in the F&O clearing business and would not
generally change those practices.
    The Procedures would outline the Clearing House's overall purposes
and objectives when managing an Event of Default by a Clearing
Member.\6\ The first objective is to take quick action to contain
losses and liquidity pressures while returning the Clearing House to a
matched book, as soon as reasonably practicable. In addition, the
Clearing House may consider other objectives, depending on the
characteristics of the default, including ensuring timely completion of
settlement, limiting disruptions to the market, and managing and
closing out the defaulter's positions and liquidating any applicable
collateral in a prudent and orderly manner. The Clearing House's
default management framework would be guided by ICE Clear Europe's
default Rules and the Default Management Policy and supporting
procedures (including the Procedures). The Procedures would further
recognize that each default is unique and the Procedures do not provide
an exhaustive list of actions ICE Clear Europe would take.
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    \6\ The Procedures would also provide that similar provisions
would apply in the case of a Sponsored Principal default. The
Procedures also note that in the case of a default of a customer of
a Clearing Member, the default Rules would not be expected to apply.
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    The Procedures would detail the governance and responsibilities of
various Clearing House personnel and committees with respect to default
management, consistent with the Default Management Policy. (These
provisions are intended to more clearly document existing practice,
rather than change practice.) The Procedures would in particular
reflect the following: the Board of Directors has delegated to the
President the authority to declare an Event of Default and take all
actions the Clearing House may take under the Rules in managing an
Event of Default. The President has the discretion to consult the ERC
Default Management Committee (``DMC''), which is a subcommittee of the
Executive Risk Committee. The President has the authority to make final
decisions but may delegate powers as appropriate. The DMC would also
assume the responsibilities of the President in the declaration and
management of an Event of Default if the President is unavailable. The
DMC would require a quorum of the majority of voting members of the
Executive Risk Committee for the DMC to make decisions and the
decisions would have to be by unanimous agreement of the voting members
of the Executive Risk Committee present in the meeting. If there are
dissenting views at the DMC level, the issue must be escalated to the
Board. Consistent with the requirements of the Rules, the Procedures
would state that a declaration of an Event of Default would be limited
to circumstances where an event in Rule 901(a) has occurred with
respect to a Clearing Member. Following an Event of Default, the Board
would have to be informed as soon as practicable of the relevant
circumstances, key steps or actions taken or determinations made or
approvals given.
    The Procedures would detail the actions that may be taken with
respect

to a potential defaulter prior to the occurrence of an Event of
Default. The Procedures would reflect that the Clearing Risk Department
(``CRD'') may perform heightened monitoring of the potential defaulter
including an increase in daily credit risk monitoring, scenario
planning for a potential default management strategy and appropriate
risk mitigation through additional collateralization. The Treasury
Department (``Treasury'') would also review its relationships and
accounts with the potential defaulter in the context of auxiliary
banking services. The Operations Department (``Operations'') may
conduct a review of operational activities relevant to the potential
defaulter. The Compliance Department (``Compliance'') would be expected
to be in close contact with regulators at times when there is an
anticipated default in relation to a Clearing Member. The Legal
Department (``Legal'') may seek the advice of outside legal counsel
regarding the laws of the defaulter's domicile country. Senior
Management may inform the senior management of the other ICE clearing
houses and exchanges of the increased monitoring of a potential
defaulter and the President may provide the Board with an update on
increased monitoring of a potential defaulter.
    The Procedures would also set out the Clearing House's actions in a
declaration of an Event of Default, in accordance with the Rules. The
President or its delegate would be expected to be in contact with the
potential defaulter in order to ensure accurate and up to date
information is available to declare an Event of Default. Prior to a
declaration of an Event of Default, Compliance would consult with and
keep informed the relevant regulatory authorities. The President or the
President's delegate may convene the DMC to discuss the potential
default. The Procedures would address internal reports that may be
considered by the DMC in connection with a potential default. If the
criteria for an Event of Default under the Rules are met, the President
(or the President's delegate) would declare an Event of Default. The
Procedures would address the process for issuing a Default notice to
the Defaulter, communicating this issuance to the relevant regulators,
issuing a Circular to the Clearing Members and a notice on its website,
as well as for communication to the Board and other relevant ICE
exchanges and clearing houses.
    The Procedures would also detail the actions ICE Clear Europe would
take immediately following the Default Notice in order to protect
itself from any further losses related to the default event. These
actions would include the convening of the DMC, suspension of the
Defaulter's trading access, prevention of payments to the Defaulter,
communication with brokers that may be used in any liquidation strategy
for default management, and confirmation of the Defaulter's positions.
    The Procedures would address procedures for client porting in
circumstances where the defaulting Clearing Member provides clearing
services to customers. Consistent with the Rules and applicable law,
the Clearing House would attempt within a predefined period to port
client positions and assets to another solvent Clearing Member, subject
to specified conditions and requirements. The Procedures would set out
certain requirements for porting notices to be provided to the Clearing
House under the Rules with respect to customers' porting preferences.
Consistent with the Rules, where porting is not performed, the Clearing
House would liquidate customer positions.
    The Procedures would set out the responsibilities of various
Clearing House departments for aspects of the default management
process. For example, the CRD is responsible for assessing the
defaulter's positions and proposing whether splitting the portfolio
would be the appropriate strategy. In making its determination the CRD
may consider combining offsetting positions of different accounts and
liquidating or hedging the remaining positions. Moreover, the CRD would
consider the portfolio's complexity and timing for the execution of the
default management process. The Procedures would note that the CRD
could determine to take various actions depending on market
circumstances, such as liquidation through private sales or brokers or
liquidation through default auctions with broader participation. The
Procedures would further address considerations in circumstances where
the Defaulter holds physically delivered contracts close to maturity
and where the defaulter's positions are in products traded across
different ICE exchanges.
    The Procedures would also address potential hedging strategies. The
CRD has the responsibility to assess the Defaulter's positions and
determine if hedge trades are useful to reduce the portfolio's risk
prior to liquidation. Hedge trades could be executed through brokers,
voluntary auctions or private sales. During the course of the hedging
strategy, the CRD would periodically re-evaluate the risk exposure as
hedges are executed and positions are liquidated. Hedging may continue
until reaching hedging/liquidation targets.
    The Procedures would also address liquidation of remaining
positions following hedging, through various strategies. The Procedures
would set out the responsibilities of the President, with advice of the
CRD, in deciding how the remaining positions can be liquidated.
Liquidation options would include holding and financing open positions
until maturity, liquidating positions or sub-portfolios via brokers,
arranging a private sale of part or the entire book, and Default
Auctions.
    The Procedures would describe the key features of the Default
Auctions, which are more fully set out in the existing published
Auction Terms for F&O Default Auctions. The Procedures would describe,
among other features, the use of a modified Dutch auction methodology,
the use of ``all or nothing'' bids, the establishment of minimum bid
requirements, customer participation, use of mirrored auctions, and
``juniorization'' of guaranty fund contributions, in accordance with
the Auction Terms for F&O Default Auctions. The Procedures also address
the process for establishing positions with winning bidders and payment
of related amounts. An annex to the Procedures would set out examples
of the operation of the auction methodology.
    The Procedures would also describe the Treasury's responsibility in
proposing to the President a liquidation strategy of non-cash
collateral provided by the Defaulter. The liquidation strategy would
take into account the liquidity waterfall as defined under the
Liquidity Stress testing methodology.
    The Procedures would also address the steps taken at the conclusion
of the transfer and close out of all the Defaulter's positions,
including an analysis of the cost of managing the event in accordance
with the default Rules. The Procedures would reflect the requirement of
the Rules that post-default, a net sum would be calculated separately
for house and customer accounts according to the methodology in the
Rules, and the net sum would be reported to the officer or
administrator responsible for the Clearing Member in default.
    The Procedures would also provide for the testing and review of the
Default Management Procedures on a quarterly basis, through practicing
certain aspects of the default management process. In addition, the
Procedures provide for the Clearing House to conduct a default test on
an annual basis with mandatory participation of the Clearing Members.
Additionally, the Procedures would list

the aims of the annual default test and quarterly reviews, and the
elements that may be included in a default management test plan.
    Finally, the Procedures would describe the process for reviews,
breach management, exception handling and document governance in a
manner generally consistent with other ICE Clear Europe policies. The
document owner identified by the Clearing House would be responsible
for ensuring that the Procedures remain up-to-date and reviewed in
accordance with the Clearing House's governance processes. Any changes
to the document would have to be approved in accordance with ICE Clear
Europe's governance process and will be implemented after the
completion of all required internal and regulatory approvals. Document
reviews would encompass at the minimum regulatory compliance,
documentation and purpose, implementation, use and open items from
previous validations or reviews. Results of the review would have to be
reported to the Executive Risk Committee or in certain cases to the
Model Oversight Committee. The document owner would also aim to
remediate the findings, complete internal governance and receive
regulatory approvals before the following annual review is due. The
document owner would also be responsible for reporting any material
breaches or deviations to the Head of Department, Chief Risk Officer
and Head of Regulation and Compliance. Exceptions to the Procedures
would also be approved in accordance with such governance processes.
(b) Statutory Basis
    ICE Clear Europe believes that the Procedures are consistent with
the requirements of Section 17A of the Act \7\ and the regulations
thereunder applicable to it. In particular, Section 17A(b)(3)(F) of the
Act \8\ requires, among other things, that the rules of a clearing
agency be designed to promote the prompt and accurate clearance and
settlement of securities transactions and, to the extent applicable,
derivative agreements, contracts, and transactions, the safeguarding of
securities and funds in the custody or control of the clearing agency
or for which it is responsible, and the protection of investors and the
public interest.
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    \7\ 15 U.S.C. 78q-1.
    \8\ 15 U.S.C. 78q-1(b)(3)(F).
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    The Procedures are designed to supplement the Default Management
Policy by setting out in additional detail the actions and processes of
the Clearing House in declaring and managing an Event of Default,
recognizing that the details of any particular default will vary. The
Procedures would more clearly set out the responsibilities of the
President, DMC and various ICE Clear Europe departments, including the
CRD, in declaring and managing an Event of Default. The Procedures
would also outline various aspects of the default management process,
including convening and use of the DMC, suspension of the Defaulter's
trading access, prevention of payments to the Defaulter, confirmation
of the Defaulter's positions, liquidity considerations, hedging
strategy and liquidation strategy (including as to various means of
liquidation, such as the use of brokers, private sales and auctions).
The Procedures would also address annual default testing with mandatory
involvement of Clearing Members, and quarterly reviews to address
various aspects of the default management process. In ICE Clear
Europe's view, the Procedures will thus facilitate management of the
risks related to a default or anticipated default from a Clearing
Member, so that the Clearing House can promptly restore a matched book
and contain losses. The Procedures will thus promote the prompt and
accurate clearing and settlement of cleared transactions and are
consistent with the protection of investors and the public interest in
the continued operation of the Clearing House in the event of a
Clearing Member default. (ICE Clear Europe would not expect the
adoption of the Procedures to materially affect the safeguarding of
securities and funds in ICE Clear Europe's custody or control or for
which it is responsible.) Accordingly, the Procedures satisfy the
requirements of Section 17A(b)(3)(F).\9\
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    \9\ 15 U.S.C. 78q-1(b)(3)(F).
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    The Procedures are also consistent with relevant provisions of Rule
17Ad-22.\10\ Rule 17Ad-22(e)(2) provides that ``[e]ach covered clearing
agency shall establish, implement, maintain and enforce written
policies and procedures reasonably designed to, as applicable [. . .]
provide for governance arrangements that are clear and transparent''
\11\ and ``[s]pecify clear and direct lines of responsibility''.\12\ As
discussed, the Procedures would state relevant responsibilities of the
President, Board, DMC, Executive Risk Committee, CRD and other ICE
Clear Europe departments in relation to oversight of default management
processes in the period leading up and following an Event of Default.
Specifically, and consistent with the Rules, Default Management Policy
and current practice, the President would have full authority in
declaring and managing an Event of Default, with the ability to
delegate if necessary or for the DMC to assume certain responsibilities
if the President is unavailable. The CRD would have the responsibility
of advising the President throughout various actions and decisions when
managing an Event of Default. In line with the Clearing House's other
policies and procedures, the Procedures would also describe the
responsibilities of the document owner and appropriate escalation and
notification requirements for responding to exceptions and deviations
from the Procedures. In ICE Clear Europe's view, the Procedures are
therefore consistent with the requirements of Rule 17Ad-22(e)(2).\13\
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    \10\ 17 CFR 240.17Ad-22. [sic]
    \11\ 17 CFR 240.17Ad-22(e)(2)(i). [sic]
    \12\ 17 CFR 240.17Ad-22(e)(2)(v). [sic]
    \13\ 17 CFR 240.17Ad-22(e)(2). [sic]
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    Rule 17Ad-22(e)(13) provides that the ``covered clearing agency
shall establish, implement, maintain and enforce written policies and
procedures reasonably designed to, as applicable [. . .] ensure that
[sic] the covered clearing agency has the authority and operational
capacity to take timely action to contain losses and liquidity demands
and continue to meet its obligations by, at a minimum, requiring the
covered clearing agency's participants and, where [sic] practicable,
other stakeholders to participate [sic] the testing and review of its
default procedures, including any close-out procedures, at least
annually and following material changes thereto.'' \14\ As discussed
above, the Procedures would address the Clearing House's practices for
testing its default management framework, which includes annual default
tests in which participation by Clearing Members is mandatory, and
further provides for additional quarterly reviews. In ICE Clear
Europe's views, these testing measures, together with the other aspects
of the Procedures and the underlying Rules, will facilitate its ability
to take timely action to contain losses and liquidity pressure in the
event of a Clearing Member default. As such, the Procedures are
consistent with the requirements of Rule 17Ad-22(e)(13).\15\
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    \14\ 17 CFR 240.17Ad-22(e)(13).
    \15\ 17 CFR 240.17Ad-22(e)(13).
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(B) Clearing Agency's Statement on Burden on Competition

    ICE Clear Europe does not believe the Procedures would have any
impact, or impose any burden, on competition not

necessary or appropriate in furtherance of the purposes of the Act. The
Procedures are being adopted to document the Clearing House's practices
and actions in the event of an Event of Default in relation to a
Clearing Member. The Procedures do not change the rights or obligations
of Clearing Members or the Clearing House under the Rules or
Procedures. The Procedures set out certain requirements for Clearing
Members to participate in annual default testing, but these
requirements reflect current practices and Clearing House does not
believe this requirement would impose a material burden on Clearing
Members. (In any event such participation is required of all Clearing
Members under Commission regulations as set out above.) Accordingly,
ICE Clear Europe does not believe that adoption of the Procedures would
adversely affect competition among Clearing Members, materially affect
the costs of clearing, adversely affect the ability of market
participants to access clearing or the market for clearing services
generally, or otherwise adversely affect competition in clearing
services. Therefore, ICE Clear Europe does not believe the proposed
rule change imposes any burden on competition that is not necessary or
appropriate in furtherance of the purposes of the Act.

(C) Clearing Agency's Statement on Comments on the Proposed Rule Change
Received From Members, Participants or Others

    Written comments relating to the proposed amendment has not been
solicited or received by ICE Clear Europe. ICE Clear Europe will notify
the Commission of any comments received with respect to the proposed
rule change.

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A) of the Act \16\ and paragraph (f) of Rule 19b-4 \17\
thereunder. At any time within 60 days of the filing of the proposed
rule change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act.
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    \16\ 15 U.S.C. 78s(b)(3)(A).
    \17\ 17 CFR 240.19b-4(f).
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IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml) or
     Send an email to [email protected]. Please include
File Number SR-ICEEU-2023-014 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-ICEEU-2023-014. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (http://www.sec.gov/rules/sro.shtml).
Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for website viewing and printing in
the Commission's Public Reference Room, 100 F Street NE, Washington, DC
20549, on official business days between the hours of 10:00 a.m. and
3:00 p.m. Copies of such filings will also be available for inspection
and copying at the principal office of ICE Clear Europe and on ICE
Clear Europe's website at https://www.theice.com/clear-europe/regulation.
    Do not include personal identifiable information in submissions;
you should submit only information that you wish to make available
publicly. We may redact in part or withhold entirely from publication
submitted material that is obscene or subject to copyright protection.
All submissions should refer to File Number SR-ICEEU-2023-014 and
should be submitted on or before July 13, 2023.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\18\
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    \18\ 17 CFR 200.30-3(a)(12).
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J. Matthew DeLesDernier,
Deputy Secretary.
[FR Doc. 2023-13211 Filed 6-21-23; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: January 16, 2009 (Volume 74, Number 11)]
[Notices]
[Page 3132-3134]
[DOCID:fr16ja09-159]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

Petition for Exemption From the Federal Motor Vehicle Motor Theft
Prevention Standard; General Motors Corporation

AGENCY: National Highway Traffic Safety Administration, Department of
Transportation (DOT).

ACTION: Grant of petition for exemption.

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SUMMARY: This document grants in full the petition of General Motors
Corporation (GM), for an exemption in accordance with Sec.  543.9(c)(2)
of 49 CFR Part 543, Exemption from the Vehicle Theft Prevention
Standard, for the GMC small crossover vehicle line beginning with model
year (MY) 2010. This petition is granted because the agency has
determined that the antitheft device to be placed on the line as
standard equipment is likely to be as effective in reducing and
deterring motor vehicle theft as compliance with the parts-marking
requirements of the Theft Prevention Standard.

DATES: The exemption granted by this notice is effective beginning with
model year (MY) 2010.

FOR FURTHER INFORMATION CONTACT: Ms. Deborah Mazyck, Office of
International Policy, Fuel Economy and Consumer Standards, NHTSA, 1200
New Jersey Avenue, SE., Washington, DC 20590. Ms. Mazyck's phone number
is<PHONE_NUMBER>. Her fax number is<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: In a petition dated September 25, 2008, GM
requested an exemption from the parts-marking requirements of the theft
prevention standard (49 CFR part 541) for the GMC small crossover
vehicle line beginning with MY 2010. The petition requested an
exemption from parts-marking pursuant to 49 CFR 543, Exemption from the
Vehicle Theft Prevention Standard, based on the installation of an
antitheft device as standard equipment for the entire vehicle line.
    Under Sec.  543.5(a), a manufacturer may petition NHTSA to grant an
exemption for one vehicle line per model year. GM has petitioned the
agency to grant an exemption for its small crossover vehicle line
beginning with MY 2010. On November 18, 2008, the agency contacted GM
by telephone to obtain additional information. GM's submission is
considered a complete petition as required by 49 CFR 543.7, in that it
meets the general requirements contained in Sec.  543.5 and the
specific content requirements of Sec.  543.6.
    GM's petition provided a detailed description and diagram of the
identity, design, and location of the components of the antitheft
device for the new vehicle line. GM will install its passive,
transponder-based, electronic immobilizer device (PASS-Key III+) as
standard equipment on its GMC small crossover vehicle line beginning
with MY 2010. GM stated that the device will provide protection against
unauthorized use (i.e., starting and engine fueling), but will not
provide any visible or audible indication of unauthorized vehicle entry
(i.e., flashing lights or horn alarm).
    The PASS-Key III+ device is designed to be active at all times
without direct intervention by the vehicle operator. The system is
fully armed immediately after the ignition has been turned off and the
key removed. Components of the antitheft device include an
electronically-coded ignition key, a PASS-Key III+ controller module
and an engine control module. The ignition key contains electronics
molded into the key head, providing billions of possible electronic
combinations. The electronics receive energy and data from the antenna
module. Upon receipt of the data, the key will calculate a response to
the data using secret information and an internal encryption algorithm,
and transmit the response back to the vehicle. The antenna module
translates the radio frequency signal received from the key into a
digital signal and compares the received response to an internally
calculated value. If the values match, the key is recognized as valid
and one of 65,534 ``Vehicle Security Passwords'' is transmitted to the
engine control module to enable fueling and starting of the vehicle. If
an invalid key code is received, the PASS-Key III+ controller module
will send a ``Disable Password'' to the engine control module and
starting, ignition, and fuel will be inhibited.
    GM indicated that the theft rates, as reported by the Federal
Bureau of Investigation's National Crime Information Center (NCIC), are
lower for exempted GM models equipped with the ``PASS-Key''-like
systems than the theft rates for earlier, similarly constructed models
which were parts-marked. Based on the performance of the PASS-Key,
PASS-Key II, and PASS-Key III systems on other GM models, and the
advanced technology utilized by the modification, GM believes that the
PASS-Key III+ antitheft device will be more effective in deterring
theft than the parts-marking requirements of 49 CFR Part 541.
    In addressing the specific content requirements of 543.6, GM
provided information on the reliability and durability of the proposed
device. To ensure reliability and durability of the device, GM
conducted tests based on its own specified standards. GM provided its
own test information on the reliability and durability of its device,
and believes that the device is reliable and durable since it complied
with the specified requirements for each test. GM stated that the PASS-
Key III+ system has been designed to enhance the functionality and
theft protection provided by GM's first, second and third generation
PASS-Key, PASS-Key II, and PASS-Key III systems. GM also stated that
since the authorization code is not handled or contacted by the vehicle
operator, the reliability of the PASS-Key III+ is significantly
improved over the PASS-Key and PASS-Key II devices. According to GM,
this reliability allows the system to return to the ``Go/No Go'' based
system, eliminating the ``fail enabled'' mode of operation.
    GM compared the device proposed for its small crossover vehicle
line with other devices which NHTSA has determined to be as effective
in reducing and deterring motor vehicle theft as would compliance with
the parts-marking requirements. GM stated that the theft rates for the
2003 and 2004 Cadillac CTS and the MY 2004 Cadillac SRX currently
installed with the PASS-Key III+ antitheft device exhibit theft rates
that are lower than the median theft rate (3.5826) established by the
agency. The Cadillac CTS introduced as a MY 2003 vehicle line has been
equipped with the PASS-Key III+ device since the start of production.
The theft rates for the MY 2003 and 2004 Cadillac CTS are 1.0108 and
0.7681 respectively. Similarly, the Cadillac SRX, introduced as a MY
2004 vehicle, has been equipped with the PASS-Key III+ device since
production. The theft rate for MY 2004 Cadillac SRX is 0.7789. GM
stated that the theft rates experienced by these lines with
installation of the PASS-Key III+ device demonstrate the effectiveness
of the device. GM also stated that its crossover vehicle is a corporate
twin to the Chevrolet Equinox which is equipped with the PASS-Key III+
device and already exempt from the parts-marking requirements. The
average theft rate for the Chevrolet Equinox using two model years'
data is 1.2073. The agency agrees that the device is substantially
similar to devices for which the agency has previously approved
exemptions.
    Based on comparison of the reduction in the theft rates of GM
vehicles using a passive theft deterrent device with an audible/visible
alarm system to the reduction in theft rates for GM vehicle models
equipped with a passive antitheft device without an alarm, GM finds
that the lack of an alarm or attention attracting device does not
compromise the theft deterrent performance of a system such as PASS-Key
III+.
    GM's proposed device lacks an audible or visible alarm. Therefore,
this device cannot perform one of the functions listed in 49 CFR part
543.6(a)(3), that is, to call attention to unauthorized attempts to
enter or move the vehicle. However, theft data have indicated a decline
in theft rates for vehicle lines equipped with comparable devices that
have received full exemptions from the parts-marking requirements. In
these instances, the agency has concluded that the lack of a audible or
visible alarm has not prevented these antitheft devices from being
effective protection against theft.
    Based on the evidence submitted by GM, the agency believes that the
antitheft device for the GM small crossover vehicle line is likely to
be as effective in reducing and deterring motor vehicle theft as
compliance with the parts-marking requirements of the Theft Prevention
Standard (49 CFR 541).
    The agency concludes that the device will provide four of the five
types of performance listed in Sec.  543.6(a)(3): promoting activation;
preventing defeat or circumvention of the device by unauthorized
persons; preventing operation of the vehicle by unauthorized entrants;
and ensuring the reliability and durability of the device.

    Pursuant to 49 U.S.C. 33106 and 49 CFR 543.7 (b), the agency grants
a petition for exemption from the parts-marking requirements of part
541, either in whole or in part, if it determines that, based upon
substantial evidence, the standard equipment antitheft device is likely
to be as effective in reducing and deterring motor vehicle theft as
compliance with the parts-marking requirements of part 541. The agency
finds that GM has provided adequate reasons for its belief that the
antitheft device for the GMC small crossover vehicle line is likely to
be as effective in reducing and deterring motor vehicle theft as
compliance with the parts-marking requirements of the Theft Prevention
Standard (49 CFR part 541). This conclusion is based on the information
GM provided about its device.
    For the foregoing reasons, the agency hereby grants in full GM's
petition for exemption for the GMC small crossover vehicle line from
the parts-marking requirements of 49 CFR part 541. The agency notes
that 49 CFR part 541, Appendix A-1, identifies those lines that are
exempted from the Theft Prevention Standard for a given model year. 49
CFR part 543.7(f) contains publication requirements incident to the
disposition of all part 543 petitions. Advanced listing, including the
release of future product nameplates, the beginning model year for
which the petition is granted and a general description of the
antitheft device is necessary in order to notify law enforcement
agencies of new vehicle lines exempted from the parts marking
requirements of the Theft Prevention Standard.
    If GM decides not to use the exemption for this line, it should
formally notify the agency. If such a decision is made, the line must
be fully marked according to the requirements under 49 CFR Parts 541.5
and 541.6 (marking of major component parts and replacement parts).
    NHTSA notes that if GM wishes in the future to modify the device on
which this exemption is based, the company may have to submit a
petition to modify the exemption. Part 543.7(d) states that a part 543
exemption applies only to vehicles that belong to a line exempted under
this part and equipped with the antitheft device on which the line's
exemption is based. Further, part 543.9(c)(2) provides for the
submission of petitions ``to modify an exemption to permit the use of
an antitheft device similar to but differing from the one specified in
that exemption.''
    The agency wishes to minimize the administrative burden that part
543.9(c)(2) could place on exempted vehicle manufacturers and itself.
The agency did not intend in drafting part 543 to require the
submission of a modification petition for every change to the
components or design of an antitheft device. The significance of many
such changes could be de minimis. Therefore, NHTSA suggests that if the
manufacturer contemplates making any changes, the effects of which
might be characterized as de minimis, it should consult the agency
before preparing and submitting a petition to modify.

    Authority: 49 U.S.C. 33106; delegation of authority at 49 CFR
1.50.

    Issued on: January 12, 2009.
Stephen R. Kratzke,
Associate Administrator for Rulemaking.
 [FR Doc. E9-947 Filed 1-15-09; 8:45 am]

BILLING CODE 4910-59-P


[Federal Register Volume 79, Number 105 (Monday, June 2, 2014)]
[Proposed Rules]
[Pages 31236-31237]
[FR Doc No: 2014-12689]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2013-0441; Airspace Docket No. 13-ASO-11]

Proposed Establishment of Class E Airspace; Pine Knot, KY

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: This action proposes to establish Class E airspace at Pine
Knot, KY, to accommodate a new Area Navigation (RNAV) Global
Positioning System (GPS) Standard Instrument Approach Procedure (SIAP)
serving McCreary County Airport. This action would enhance the safety
and airspace management of Instrument Flight Rules (IFR) operations
within the National Airspace System.

DATES: Comments must be received on or before July 17, 2014.

ADDRESSES: Send comments on this rule to: U.S. Department of
Transportation, Docket Operations, West Building Ground Floor, Room
W12-140, 1200 New Jersey, SE., Washington, DC 20590-0001; Telephone: 1-
800-647-5527; Fax:<PHONE_NUMBER>. You must identify the Docket Number
FAA-2013-0441; Airspace Docket No. 13-ASO-11, at the beginning of your
comments. You may also submit and review received comments through the
Internet at http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: John Fornito, Operations Support
Group, Eastern Service Center, Federal Aviation Administration, P.O.
Box 20636, Atlanta, Georgia 30320; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    Interested persons are invited to comment on this rulemaking by
submitting such written data, views, or arguments, as they may desire.
Comments that provide the factual basis supporting the views and
suggestions presented are particularly helpful in developing reasoned
regulatory decisions on the proposal. Comments are specifically invited
on the overall regulatory, aeronautical, economic, environmental, and
energy-related aspects of the proposal.
    Communications should identify both docket numbers (FAA Docket No.
FAA-2013-0441; Airspace Docket No. 13-ASO-11) and be submitted in
triplicate to the Docket Management System (see ADDRESSES section for
address and phone number). You may also submit comments through the
Internet at http://www.regulations.gov.
    Persons wishing the FAA to acknowledge receipt of their comments on
this action must submit with those comments a self-addressed stamped
postcard on which the following statement is made: ``Comments to Docket
No. FAA-2013-0441; Airspace Docket No. 13-ASO-11.'' The postcard will
be date/time stamped and returned to the commenter.
    All communications received before the specified closing date for
comments will be considered before taking action on the proposed rule.
The proposal contained in this notice may be changed in light of the
comments received. A report summarizing each substantive public contact
with FAA personnel concerned with this rulemaking will be filed in the
docket.

Availability of NPRMs

    An electronic copy of this document may be downloaded from and
comments submitted through http://www.regulations.gov. Recently
published rulemaking documents can also be accessed through the FAA's
Web page at http://www.faa.gov/airports_airtraffic/air_traffic/publications/airspace_amendments/.
    You may review the public docket containing the proposal, any
comments received and any final disposition in person in the Dockets
Office (see the ADDRESSES section for address and phone number) between
9:00 a.m. and 5:00 p.m., Monday through Friday, except Federal
Holidays. An informal docket may also be examined between 8:00 a.m. and
4:30 p.m., Monday through Friday, except Federal Holidays, at the
office of the Eastern Service Center, Federal Aviation Administration,
Room 350, 1701 Columbia Avenue, College Park, Georgia 30337.
    Persons interested in being placed on a mailing list for future
NPRM's should contact the FAA's Office of Rulemaking,<PHONE_NUMBER>,
to request a copy of Advisory circular No. 11-2A, Notice of Proposed
Rulemaking distribution System, which describes the application
procedure.

The Proposal

    The FAA is considering an amendment to Title 14, Code of Federal
Regulations (14 CFR) part 71 to establish Class E airspace at Pine
Knot, KY, providing the controlled airspace required to support the new
RNAV (GPS) standard instrument approach procedures for McCreary County
Airport. Controlled airspace extending upward from 700 feet above the
surface is required for IFR operations within a 9.3-mile radius of the
airport.
    Class E airspace designations are published in Paragraph 6005 of
FAA order 7400.9X, dated August 7, 2013, and effective September 15,
2013, which is incorporated by reference in 14 CFR 71.1. The Class E
airspace designation listed in this document will be published
subsequently in the Order.
    The FAA has determined that this proposed regulation only involves
an established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore, (1) is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under DOT
Regulatory Policies and Procedures (44 FR 11034; February 26, 1979);
and (3) does not warrant preparation of a Regulatory Evaluation as the
anticipated impact is so minimal. Since this is a routine matter that
will only affect air traffic procedures and air navigation, it is
certified that this proposed rule, when promulgated, would not have a
significant economic impact on a substantial number of small entities
under the criteria of the Regulatory Flexibility Act.
    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. Subtitle I, Section 106
describes the authority of the FAA Administrator. Subtitle VII,
Aviation Programs, describes in more detail the scope of the agency's
authority. This proposed rulemaking is promulgated under the authority
described in Subtitle VII, Part, A, Subpart I, Section 40103. Under
that section, the FAA is charged with prescribing regulations to assign
the use of airspace necessary to ensure the safety of aircraft and the
efficient use of airspace. This proposed regulation is within the scope
of that authority as it would establish Class E airspace at McCreary
County Airport, Pine Knot, KY.
    This proposal will be subject to an environmental analysis in
accordance with FAA Order 1050.1E, ``Environmental Impacts: Policies
and Procedures'' prior to any FAA final regulatory action.

Lists of Subjects in 14 CFR Part 71:

    Airspace, Incorporation by reference, Navigation (air).

The Proposed Amendment:

    In consideration of the foregoing, the Federal Aviation
Administration proposes to amend 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for part 71 continues to read as follows:

    Authority:  49 U.S.C. 106(g); 40103, 40113, 40120; E.O. 10854,
24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of Federal Aviation
Administration Order 7400.9X, Airspace Designations and Reporting
Points, dated August 7, 2013, effective September 15, 2013, is amended
as follows:

Paragraph 6005 Class E Airspace Areas Extending Upward From 700
Feet or More Above the Surface of the Earth.

* * * * *

ASO KY E5 Pine Knot, KY [New]

McCreary County Airport, KY
    (Lat. 36[deg]41'43'' N., long. 84[deg]23'29'' W.)

    That airspace extending upward from 700 feet above the surface
within a 9.3-mile radius of McCreary County Airport.

    Issued in College Park, Georgia, on May 21, 2014.
Myron A. Jenkins,
Manager, Operations Support Group, Eastern Service Center, Air Traffic
Organization.
[FR Doc. 2014-12689 Filed 5-30-14; 8:45 am]
BILLING CODE 4910-13-P


MEMORANDUM

DATE:		June 25, 2014

TO:		Carbon Power Plan for Existing Power Plants; Docket Id: OAR - 2013-0602

FROM:	Carl Daly, EPA Region 8

SUBJECT:	June 19, 2014, Meeting with Metro Denver Economic Development Council Regarding Proposed Carbon Power Plan for Existing Power Plants  --------------------------------------------------------------------------------

SUMMARY

      A one hour meeting was held between EPA and the attendees listed below on June 19, 2014 to discuss factual information related to the proposed Carbon Power Plan for Existing Power Plants (111(d)). The Carbon Power Plan for Existing Power Plants was proposed on June 2, 2014.        ATTENDEES Carl Daly, EPA Region 8 Scott Prestridge, Metro Denver Economic Development Council Jack Isley, Xcel Energy Jennifer Jones, Denver Metro Chamber of Commerce Dave Lock, Tri-State Generation and Transmission Association Tom Dougherty, Lewis Roca Rothgerber, LLP David Hiller, Colorado Energy Research Collaboratory Glenn Johnston, GEVO Eric Doan, Crow Horwath, PC


[Federal Register Volume 78, Number 56 (Friday, March 22, 2013)]
[Notices]
[Pages 17650-17651]
[FR Doc No: 2013-06600]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings 2

    Take notice that the Commission received the following electric
rate filings:
    Docket Numbers: ER10-2238-004; ER10-2239-004; ER10-2237-003; ER10-
1821-005; ER11-4475-005.
    Applicants: Indigo Generation LLC, Larkspur Energy LLC, Wildflower
Energy LP, Goshen Phase II LLC, Rockland Wind Farm LLC.
    Description: Notice of Non-Material Change in Status of the DGC
Companies.
    Filed Date: 3/14/13.
    Accession Number: 20130314-5184.
    Comments Due: 5 p.m. ET 4/4/13.

    Docket Numbers: ER13-633-001.
    Applicants: Public Service Company of Colorado.
    Description: Public Service Company of Colorado submits 2013-03-15-
NSP-BARRON-Tran-to Load-543 to be effective 1/1/2013.
    Filed Date: 3/15/13.
    Accession Number: 20130315-5070.
    Comments Due: 5 p.m. ET 4/5/13.

    Docket Numbers: ER13-656-001.
    Applicants: Public Service Company of Colorado.
    Description: 2013-03-14-NSP-TREMPLO-Tran-to Load-549 to be
effective 1/1/2013.
    Filed Date: 3/15/13.
    Accession Number: 20130315-5003.
    Comments Due: 5 p.m. ET 4/5/13.

    Docket Numbers: ER13-672-001.
    Applicants: Public Service Company of Colorado.
    Description: Public Service Company of Colorado submits 2013-03-15-
NSP-RCLK-Tran-to Load-547 to be effective 1/1/2013.
    Filed Date: 3/15/13.
    Accession Number: 20130315-5048.
    Comments Due: 5 p.m. ET 4/5/13.

    Docket Numbers: ER13-791-001.
    Applicants: Midwest Independent Transmission System Operator, Inc.
    Description: Midwest Independent Transmission System Operator, Inc.
submits 03-15-2013 SA 2478 METC-Traverse IFA to be effective 3/24/2013.
    Filed Date: 3/15/13.
    Accession Number: 20130315-5074.
    Comments Due: 5 p.m. ET 4/5/13.

    Docket Numbers: ER13-1101-000.
    Applicants: Spectrum Nevada Solar, LLC.
    Description: Application and Initial Baseline Tariff Filing to be
effective 4/24/2013.
    Filed Date: 3/15/13.
    Accession Number: 20130315-5000.
    Comments Due: 5 p.m. ET 4/5/13.

    Docket Numbers: ER13-1102-000.
    Applicants: Southern California Edison Company.
    Description: GIA and Distribution Service Agreement CA PV Energy,
LLC at 1670 Champagne Ave to be effective 3/16/2013.
    Filed Date: 3/15/13.
    Accession Number: 20130315-5001.
    Comments Due: 5 p.m. ET 4/5/13.

    Docket Numbers: ER13-1103-000.
    Applicants: Southern California Edison Company.
    Description: GIA and Distribution Service Agreement CA PV Energy,
LLC at 2825 Jurupa Ave to be effective 3/16/2013.
    Filed Date: 3/15/13.
    Accession Number: 20130315-5002.
    Comments Due: 5 p.m. ET 4/5/13.

    Docket Numbers: ER13-1104-000.
    Applicants: Just Energy Illinois Corp.
    Description: Just Energy Illinois Corp. submits Market-Based Rates
application to be effective 5/14/2013.
    Filed Date: 3/15/13.
    Accession Number: 20130315-5047.
    Comments Due: 5 p.m. ET 4/5/13.

    Docket Numbers: ER13-1105-000.
    Applicants: Florida Power Corporation, Duke Energy Carolinas, LLC.
    Description: Florida Power Corporation submits Joint OATT Florida
CWIP Filing to be effective 5/15/2013.
    Filed Date: 3/15/13.
    Accession Number: 20130315-5056.
    Comments Due: 5 p.m. ET 4/5/13.

    Docket Numbers: ER13-1106-000.
    Applicants: Wisconsin Public Service Corporation.
    Description: Wisconsin Public Service Corporation submits WPSC
Annual PEB/PBOP Filing to be effective 4/1/2013 under ER13-1106 Filing
Type: 10.
    Filed Date: 3/15/13.
    Accession Number: 20130315-5076.
    Comments Due: 5 p.m. ET 4/5/13.

    Docket Numbers: ER13-1107-000.
    Applicants: FM Energy Scheduling, LLC.
    Description: FM Energy Scheduling, LLC submits FMES MBRA
Application to be effective 6/1/2013.
    Filed Date: 3/15/13.
    Accession Number: 20130315-5079.
    Comments Due: 5 p.m. ET 4/5/13.

    Docket Numbers: ER13-1108-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: PJM Interconnection, L.L.C. submits Original Service
Agreement No. 3515 Queues V4-006, V4-007, V4-030, V4-031 to be
effective 2/13/2013.
    Filed Date: 3/15/13.
    Accession Number: 20130315-5080.
    Comments Due: 5 p.m. ET 4/5/13.

    Docket Numbers: ER13-1109-000.
    Applicants: Midwest Independent Transmission System Operator, Inc.
    Description: Midwest Independent Transmission System Operator, Inc.
submits 03-15-2013 to be effective 5/14/2013.
    Filed Date: 3/15/13.
    Accession Number: 20130315-5089.
    Comments Due: 5 p.m. ET 4/5/13.

    Take notice that the Commission received the following electric
securities filings:
    Docket Numbers: ES13-18-000.
    Applicants: Midwest Independent Transmission System Operator, Inc.
    Description: Section 204 Application of Midwest Independent
Transmission System Operator, Inc.
    Filed Date: 3/14/13.
    Accession Number: 20130314-5187.
    Comments Due: 5 p.m. ET 4/4/13.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: March 15, 2013.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2013-06600 Filed 3-21-13; 8:45 am]
BILLING CODE 6717-01-P


OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C.  20460 OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C.  20460

VIA EMAIL

Mr. Jon C. Wood AMVAC Chemical Corporation 4695 MacArthur Court, Suite 1200 Newport Beach, CA 92660

Subject: Notification of Outstanding Data Requirements, and Anticipated Registration Review Schedule for DCPA

Dear Mr. Wood:

EPA is contacting AMVAC to confirm that the Agency intends to complete all Registration Review Interim Decisions by October 1, 2022 for all pesticides registered as of October 1, 2007, fifteen years after the initiation of Registration Review. In order to meet this deadline for DCPA, EPA expects to complete the draft risk assessments in June 2021. A substantial portion of the data required in the Data Call-In (DCI) (see below) has not yet been submitted and is outstanding. The Agency will rely upon data available at the time when the risk assessments are being developed. Where the Agency is lacking data, conservative assumptions may be used in their place to complete the risk assessments.

In 2013, the Agency issued a Generic DCI for DCPA which has not been completely satisfied:  Generic Data Call-In GDCI-078701-1140, dated January 31, 2013      Please arrange for the generation and submission of any data which is not waived. The status of data required is listed in the table attached to this letter.

You are requested to respond within seven days to acknowledge receipt of this letter and to provide a response in 30 days indicating how you intend to satisfy the remaining data requirements, including a timeline for the generation and submission of outstanding data. EPA would like to remind AMVAC that completion and submission of required studies will not necessarily lead to changes in the risk estimates or safety factors used in the Draft Risk Assessment. These data are required by the DCI and, if submitted in a timely manner, EPA expects to use them in Registration Review to assess the risks of the chemical. If you have any questions, please feel free to contact James Douglass in writing at<EMAIL_ADDRESS>

                              Sincerely,

						Elissa Reaves, PhD 						Acting Division Director, 						Pesticide Re-evaluation Division 						Office of Pesticide Programs

Attachment-- Status of DCPA GDCI-078701-1140 with Current Due Dates (as of October 16, 2020)

cc Ed Messina     Alexandra Dapolito Dunn, Esq. Attachment--Status of DCPA GDCI-078701-1140 with Current Due Dates (as of October 16, 2020)

Guideline No.

Study Title Study Status Due Date 835.1230 Adsorption/desorption (TPA) Supplemental, ; additional data not required. 01/31/2014 835.1240 Leaching (TPA) In review 01/31/2014 835.2120 Hydrolysis (TPA) Waived[2]

835.4100 Aerobic soil metabolism (TPA) Supplemental2, ; additional data not required. 01/31/2015 835.4200 Anaerobic soil metabolism (TPA) Waiver request denied: outstanding[2] 01/31/2015 835.4300 Aerobic aquatic metabolism (DCPA) Supplemental2, ; additional data not required. 01/31/2015 835.4300 Aerobic aquatic metabolism (TPA) Waiver request denied; outstanding[5] 01/31/2015 835.4400 Anaerobic aquatic metabolism (TPA) Waiver request denied; outstanding 01/31/2015 835.6100 Terrestrial field dissipation (DCPA) Waiver request denied; outstanding[5] 01/31/2015 835.6100 Terrestrial field dissipation (TPA) Waiver request denied; outstanding[5] 01/31/2015 850.1010 Acute toxicity, freshwater invertebrates (daphnid) (DCPA) In review 01/31/2014 850.1010 Acute toxicity, freshwater invertebrates (daphnid) (TPA) In review 01/31/2014 850.1025 Acute toxicity, oyster (shell deposition) (DCPA) In review 01/31/2014 850.1025 Acute toxicity, oyster (shell deposition) (TPA) Waiver request denied; outstanding[5] 01/31/2014 850.1035 Acute toxicity, mysid (estuarine/marine invertebrate) (DCPA) In review 01/31/2014 850.1035 Acute toxicity mysid, (estuarine/marine invertebrate) (TPA) Waiver request denied; outstanding[5] 01/31/2014 850.1075 Acute toxicity, freshwater fish (rainbow trout) (DCPA) In review 01/31/2014 850.1075 Acute toxicity, freshwater fish (bluegill sunfish) (DCPA)  In review 01/31/2014 850.1075 Acute toxicity, estuarine/marine fish (sheepshead minnow) (DCPA) In review 01/31/2014 850.1075 Acute toxicity, freshwater fish (rainbow trout) (TPA) Waiver request denied; outstanding[5] 01/31/2014 850.1075 Acute toxicity, freshwater fish (bluegill sunfish) (TPA) Waiver request denied; outstanding[5] 01/31/2014 850.1075 Acute toxicity, estuarine/marine fish (sheepshead minnow) (TPA) Waiver request denied; outstanding[5] 01/31/2014 850.1300 Aquatic invertebrate life-cycle, freshwater (DCPA) In review 01/31/2014 850.1300 Aquatic invertebrate life-cycle, freshwater (TPA) In review 01/31/2014 850.1350 Aquatic invertebrate life-cycle, estuarine/marine (DCPA) In review 01/31/2014 850.1350 Aquatic invertebrate life-cycle, estuarine/marine (TPA) Waiver request denied; outstanding[5] 01/31/2014 850.1400 Fish early life-stage (rainbow trout) (DCPA) Supplemental[,] ; additional data not required. 01/31/2014 850.1400 Fish early life-stage (bluegill sunfish) (DCPA) Outstanding 01/31/2014 850.1400 Fish early life-stage (sheepshead minnow) (DCPA) Outstanding 01/31/2014 850.1400 Fish early life-stage (rainbow trout) (TPA) Waiver request denied; outstanding[5] 01/31/2014 850.1400 Fish early life-stage (bluegill sunfish) (TPA) Waiver request denied; outstanding[5] 01/31/2014 850.1400 Fish early life-stage (sheepshead minnow) (TPA) Waiver request denied; outstanding[5] 01/31/2014 850.1730 Fish bio-concentration (TPA) Waived[5]

850.2100 Acute avian oral, passerine species (DCPA) In review 01/31/2014 850.2300 Avian reproduction (DCPA) Waived[5]     850.4100 Tier I Plant toxicity - Seedling Emergence (DCPA) In review 01/31/2014 850.4100 Tier I Plant toxicity - Seedling Emergence (TPA) Waiver request denied; outstanding[5] 01/31/2014 850.4150 Tier I Plant toxicity - Vegetative Vigor (DCPA) In review 01/31/2014 850.4150 Tier I Plant toxicity - Vegetative Vigor (TPA) Waived 01/31/2014 850.4400 Aquatic vascular plant growth Tier I/II Plant toxicity (Lemna spp.) (DCPA) In review 01/31/2014 850.4400 Aquatic vascular plant growth Tier I/II Plant toxicity (Lemna spp.) (TPA) Waiver request denied; outstanding[5] 01/31/2014 850.4500 Algal toxicity test, Tier I/II (DCPA) In review 01/31/2014 850.4500 Algal toxicity test, Tier I/II (TPA) Outstanding 01/31/2014 860.1300 Nature of the residue: poultry In review; label amendments submitted to satisfy guideline 01/31/2015 860.1340 Residue analytical method: livestock commodities In review; label amendments submitted to satisfy guideline 01/31/2015 860.1380 Storage stability Satisfied     860.1480 Meat/milk/ poultry/eggs In review; label amendments submitted to satisfy guideline 01/31/2015 860.1900 Field accumulation in rotational crops In review; label amendments submitted to satisfy guideline 01/31/2016 870.3465 Subchronic inhalation toxicity study - 90 day Satisfied     870.6200 Neurotoxicity battery  Satisfied     870.7800 Immunotoxicity Waived     SS-1066 Chronic Sediment - Hyalella azteca (DCPA) In review 01/31/2015 SS-1069 Chronic Sediment - Chironomus dilutus (DCPA) In review 01/31/2015 SS-1072 Chronic Sediment - Leptocheirus plumulosus (DCPA) Waiver request denied; outstanding; Guideline 850.1740 (spiked whole sediment 10‐day toxicity test, saltwater invertebrates) may proceed in the interim and results may allow EPA to reconsider waiver request for SS-1072 01/31/2015 SS-1075 Avian inhalation toxicity (DCPA) Waived on condition of limiting applications to ground applications only; waiver request denied if aerial applications remain on label.[2] 10/31/2013 SS-thyroid toxicity Comparative thyroid study (DCPA) Outstanding 01/31/2015


[Federal Register Volume 83, Number 106 (Friday, June 1, 2018)]
[Rules and Regulations]
[Pages 25390-25392]
[FR Doc No: 2018-11833]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 81

[EPA-R04-OAR-2018-0017; FRL-9978-93-Region 4]

Air Plan Approval and Air Quality Designation; SC; Redesignation
of the Greenville-Spartanburg Unclassifiable Area

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: On January 22, 2018, the State of South Carolina, through the
Department of Health and Environmental Control (DHEC), submitted a
request for the Environmental Protection Agency (EPA) to redesignate
the Greenville-Spartanburg, South Carolina fine particulate matter
(PM2.5) unclassifiable area (hereinafter referred to as the
``Greenville Area'' or ``Area'') to unclassifiable/attainment for the
1997 primary and secondary annual PM2.5 national ambient air
quality standards (NAAQS). The Greenville Area is comprised of
Anderson, Greenville, and Spartanburg Counties in South Carolina. EPA
is approving the State's request and redesignating the Area to
unclassifiable/attainment for the 1997 primary and secondary annual
PM2.5 NAAQS based upon valid, quality-assured, and certified
ambient air monitoring data showing that the PM2.5 monitors
in the Area are in compliance with the 1997 primary and secondary
annual PM2.5 NAAQS.

DATES: This rule will be effective July 2, 2018.

ADDRESSES: EPA has established a docket for this action under Docket
Identification No. EPA-R04-OAR-2018-0017. All documents in the docket
are listed on the www.regulations.gov website. Although listed in the
index, some information may not be publicly available, i.e.,
Confidential Business Information 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 either electronically through www.regulations.gov or in hard
copy at the Air Regulatory Management Section, Air Planning and
Implementation Branch, Air, Pesticides and Toxics Management Division,
U.S. Environmental Protection Agency,

Region 4, 61 Forsyth Street SW, Atlanta, Georgia 30303-8960. EPA
requests that if at all possible, you contact the person listed in the
FOR FURTHER INFORMATION CONTACT section to schedule your inspection.
The Regional Office's official hours of business are Monday through
Friday 8:30 a.m. to 4:30 p.m., excluding Federal holidays.

FOR FURTHER INFORMATION CONTACT: Madolyn Sanchez, Air Regulatory
Management Section, Air Planning and Implementation Branch, Air,
Pesticides and Toxics Management Division, U.S. Environmental
Protection Agency, Region 4, 61 Forsyth Street SW, Atlanta, Georgia
30303-8960. Ms. Sanchez can be reached by telephone at<PHONE_NUMBER>
or via electronic mail at [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    On July 18, 1997 (62 FR 38652), EPA revised the NAAQS for
particulate matter to add new standards for PM2.5 (annual
and 24-hour). The primary and secondary annual standards were each set
at a level of 15.0 micrograms per cubic meter ([mu]g/m\3\), based on a
3-year average of annual mean PM2.5 concentrations. The
primary and secondary 24-hour standards were each set at a level of 65
[mu]g/m\3\, based on a 3-year average of the 98th percentile of 24-hour
concentrations. EPA established the standards based on significant
evidence and numerous health studies demonstrating that serious health
effects are associated with exposures to particulate matter.
    The process for designating areas following promulgation of a new
or revised NAAQS is contained in section 107(d)(1) of the Clean Air Act
(CAA). EPA and state air quality agencies initiated the monitoring
process for the 1997 PM2.5 NAAQS in 1999, and deployed all
air quality monitors by January 2001. On January 5, 2005 (70 FR 944),
EPA designated areas across the country as nonattainment,
unclassifiable, or unclassifiable/attainment \1\ for the 1997
PM2.5 NAAQS based upon air quality monitoring data from
these monitors for calendar years 2001-2003.
---------------------------------------------------------------------------

    \1\ For the initial PM area designations in 2005 (for the 1997
PM2.5 NAAQS), EPA used a designation category of
``unclassifiable/attainment'' for areas that had monitors showing
attainment of the standard and were not contributing to nearby
violations and for areas that did not have monitors but for which
EPA had reason to believe were likely attaining the standard and not
contributing to nearby violations. EPA used the category
``unclassifiable'' for areas in which EPA could not determine, based
upon available information, whether or not the NAAQS was being met
and/or EPA had not determined the area to be contributing to nearby
violations. EPA reserves the ``attainment'' category for when EPA
redesignates a nonattainment area that has attained the relevant
NAAQS and has an approved maintenance plan.
---------------------------------------------------------------------------

    Greenville County, South Carolina, had a monitor with less than
three years of data because the monitor had not been in operation for
the full 2001-2003 period. Based upon the data that was obtained during
its operation, the monitor indicated a potential to violate the 1997
annual PM2.5 NAAQS. Also, Anderson and Spartanburg Counties
had emissions and population levels that potentially contributed to the
elevated concentrations of PM2.5 at the Greenville monitor
in question. Therefore, EPA designated all three counties--Anderson,
Greenville and Spartanburg--as unclassifiable for the 1997 annual
PM2.5 NAAQS.
    On January 22, 2018, South Carolina submitted a request for EPA to
redesignate the Greenville Area to unclassifiable/attainment for the
1997 annual PM2.5 NAAQS now that there is sufficient data to
determine that the Area is in attainment. In a notice of proposed
rulemaking (NPRM) published on March 13, 2018 (83 FR 10814), EPA
proposed to approve the State's redesignation request. The details of
South Carolina's submittal and the rationale for EPA's actions are
further explained in the NPRM. EPA did not receive any adverse comments
on the proposed action.

II. Final Action

    EPA is approving South Carolina's redesignation request and
redesignating the Greenville Area from unclassifiable to
unclassifiable/attainment for the 1997 primary and secondary annual
PM2.5 NAAQS.

III. Statutory and Executive Order Reviews

    Under the CAA, redesignation of an area to unclassifiable/
attainment is an action that affects the status of a geographical area
and does not impose any additional regulatory requirements on sources
beyond those imposed by state law. A redesignation to unclassifiable/
attainment does not in and of itself create any new requirements.
Accordingly, this action merely redesignates an area to unclassifiable/
attainment and does not impose additional requirements. 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);
     is not an Executive Order 13771 (82 FR 9339, February 2,
2017) regulatory action because redesignations are exempted under
Executive Order 12866;
     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
     will not have disproportionate human health or
environmental effects under Executive Order 12898 (59 FR 7629, February
16, 1994).
    In addition, this action does not have Tribal implications as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000). The
Catawba Indian Nation Reservation is located within the State of South
Carolina. Pursuant to the Catawba Indian Claims Settlement Act, S.C.
Code Ann. 27-16-120, ``all state and local environmental laws and
regulations apply to the Catawba Indian Nation and Reservation and are
fully enforceable by all relevant state and local agencies and
authorities.'' However, because no tribal lands are located within the
Area and the redesignation does not create new requirements, EPA has
determined that this rule does not have substantial direct effects on
an Indian Tribe. EPA notes this action will not impose substantial
direct costs on Tribal governments or preempt Tribal law.
    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).
    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 July 31, 2018. 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 may not be challenged later in proceedings to
enforce its requirements. See section 307(b)(2).

List of Subjects in 40 CFR Part 81

    Environmental protection, Air pollution control, National parks,
Wilderness areas.

    Dated: May 18, 2018.
Onis'' Trey'' Glenn, III,
Regional Administrator, Region 4.
    40 CFR part 81 is amended as follows:

PART 81--DESIGNATION OF AREAS FOR AIR QUALITY PLANNING PURPOSES

0
1. The authority citation for part 81 continues to read as follows:

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

0
2. In Sec.  81.341, the table entitled ``South Carolina-1997 Annual
PM2.5 NAAQS (Primary and secondary)'' is amended under the
heading ``Greenville-Spartanburg, SC:'' by revising the entries for
``Anderson County'', ``Greenville County'', and ``Spartanburg County''
to read as follows:

Sec.  81.341  South Carolina.

* * * * *

                                     South Carolina--1997 Annual PM2.5 NAAQS
                                             [Primary and secondary]
----------------------------------------------------------------------------------------------------------------
                                                    Designation a                         Classification
          Designated area          -----------------------------------------------------------------------------
                                            Date 1                  Type               Date            Type
----------------------------------------------------------------------------------------------------------------
Greenville-Spartanburg, SC:
    Anderson County...............  June 1, 2018.........  Unclassifiable/
                                                            Attainment.
    Greenville County.............  June 1, 2018.........  Unclassifiable/
                                                            Attainment.
    Spartanburg County............  June 1, 2018.........  Unclassifiable/
                                                            Attainment.

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
\a\ Includes Indian Country located in each county or area, except as otherwise specified.
\1\ This date is 90 days after January 5, 2005, unless otherwise noted.

* * * * *
[FR Doc. 2018-11833 Filed 5-31-18; 8:45 am]
BILLING CODE 6560-50-P