[Federal Register Volume 77, Number 238 (Tuesday, December 11, 2012)]
[Notices]
[Pages 73719-73726]
[FR Doc No: 2012-29842]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-68362; File No. 4-551]

Program for Allocation of Regulatory Responsibilities Pursuant to
Rule 17d-2; Notice of Filing and Order Approving and Declaring
Effective an Amendment to the Plan for the Allocation of Regulatory
Responsibilities Among NYSE MKT LLC, BATS Exchange, Inc., BOX Options
Exchange LLC, C2 Options Exchange, Incorporated, the Chicago Board
Options Exchange, Incorporated, the International Securities Exchange
LLC, Financial Industry Regulatory Authority, Inc., NYSE Arca, Inc.,
The NASDAQ Stock Market LLC, NASDAQ OMX BX, Inc., the NASDAQ OMX PHLX,
Inc. and Miami International Securities Exchange, LLC Concerning
Options-Related Market Surveillance

December 5, 2012.
    Notice is hereby given that the Securities and Exchange Commission
(``Commission'') has issued an Order, pursuant to Section 17(d) of the
Securities Exchange Act of 1934 (``Act''),\1\ approving and declaring
effective an amendment to the plan for allocating regulatory
responsibility (``Plan'') filed on November 20, 2012, pursuant to Rule
17d-2 of the Act,\2\ by NYSE MKT LLC (``MKT''), BATS Exchange, Inc.,
(``BATS''), the BOX Options Exchange LLC (``BOX''), C2 Options
Exchange, Incorporated (``C2''), the Chicago Board Options Exchange,
Incorporated (``CBOE''), the International Securities Exchange LLC
(``ISE''), Financial Industry Regulatory Authority, Inc. (``FINRA''),
NYSE Arca, Inc. (``Arca''), The NASDAQ Stock Market LLC (``Nasdaq''),
NASDAQ OMX BX, Inc. (``BX''), NASDAQ OMX PHLX, Inc. (``PHLX''), and
Miami International Securities Exchange (``MIAX'') (collectively,
``Participating Organizations'' or ``parties'').
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    \1\ 15 U.S.C. 78q(d).
    \2\ 17 CFR 240.17d-2.
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I. Introduction

    Section 19(g)(1) of the Act,\3\ among other things, requires every
self-regulatory organization (``SRO'') registered as either a national
securities exchange or national securities association to examine for,
and enforce compliance by, its members and persons associated with its
members with the Act, the rules and regulations thereunder, and the
SRO's own rules, unless the SRO is relieved of this responsibility
pursuant to Section 17(d) \4\ or Section 19(g)(2) \5\ of the Act.
Without this relief, the statutory obligation of each individual SRO
could result in a pattern of multiple examinations of broker-dealers
that maintain memberships in more than one SRO (``common members'').
Such regulatory duplication would add unnecessary expenses for common
members and their SROs.
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    \3\ 15 U.S.C. 78s(g)(1).
    \4\ 15 U.S.C. 78q(d).
    \5\ 15 U.S.C. 78s(g)(2).
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    Section 17(d)(1) of the Act \6\ was intended, in part, to eliminate
unnecessary multiple examinations and regulatory duplication.\7\ With
respect to a common member, Section 17(d)(1) authorizes the Commission,
by rule or order, to relieve an SRO of the responsibility to receive
regulatory reports, to examine for and enforce compliance with
applicable statutes, rules, and regulations, or to perform other
specified regulatory functions.
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    \6\ 15 U.S.C. 78q(d)(1).
    \7\ See Securities Act Amendments of 1975, Report of the Senate
Committee on Banking, Housing, and Urban Affairs to Accompany S.
249, S. Rep. No. 94-75, 94th Cong., 1st Session 32 (1975).
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    To implement Section 17(d)(1), the Commission adopted two rules:
Rule 17d-1 and Rule 17d-2 under the Act.\8\ Rule 17d-1 authorizes the
Commission to name a single SRO as the designated examining authority
(``DEA'') to examine common members for compliance with the financial
responsibility requirements imposed by the Act, or by Commission or SRO
rules.\9\ When an SRO has been named as a common member's DEA, all
other SROs to which the common member belongs are relieved of the
responsibility to examine the firm for compliance with the applicable
financial responsibility rules. On its face, Rule 17d-1 deals only with
an SRO's obligations to enforce

member compliance with financial responsibility requirements. Rule 17d-
1 does not relieve an SRO from its obligation to examine a common
member for compliance with its own rules and provisions of the federal
securities laws governing matters other than financial responsibility,
including sales practices and trading activities and practices.
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    \8\ 17 CFR 240.17d-1 and 17 CFR 240.17d-2, respectively.
    \9\ See Securities Exchange Act Release No. 12352 (April 20,
1976), 41 FR 18808 (May 7, 1976).
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    To address regulatory duplication in these and other areas, the
Commission adopted Rule 17d-2 under the Act.\10\ Rule 17d-2 permits
SROs to propose joint plans for the allocation of regulatory
responsibilities with respect to their common members. Under paragraph
(c) of Rule 17d-2, the Commission may declare such a plan effective if,
after providing for notice and comment, it determines that the plan is
necessary or appropriate in the public interest and for the protection
of investors, to foster cooperation and coordination among the SROs, to
remove impediments to, and foster the development of, a national market
system and a national clearance and settlement system, and is in
conformity with the factors set forth in Section 17(d) of the Act.
Commission approval of a plan filed pursuant to Rule 17d-2 relieves an
SRO of those regulatory responsibilities allocated by the plan to
another SRO.
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    \10\ See Securities Exchange Act Release No. 12935 (October 28,
1976), 41 FR 49091 (November 8, 1976).
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II. The Plan

    On December 11, 2007, the Commission declared effective the
Participating Organizations' Plan for allocating regulatory
responsibilities pursuant to Rule 17d-2.\11\ On April 11, 2008, the
Commission approved an amendment to the Plan to include NASDAQ as a
participant.\12\ On October 9, 2008, the Commission approved an
amendment to the Plan to clarify that the term Regulatory
Responsibility for options position limits includes the examination
responsibilities for the delta hedging exemption.\13\ On February 25,
2010, the Commission approved an amendment to the Plan to add BATS
Exchange, Inc. and C2 Options Exchange, Incorporated as SRO
participants and to reflect the name changes of the American Stock
Exchange LLC to the NYSE Amex LLC, and the Boston Stock Exchange, Inc.
to the NASDAQ OMX BX, Inc.\14\ On May 11, 2012, the Commission approved
an amendment to the Plan to add BOX Options Exchange LLC as a
participant to the Plan.\15\
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    \11\ See Securities Exchange Act Release No. 56941 (December 11,
2007), 72 FR 71723 (December 18, 2007) (File No. 4-551).
    \12\ See Securities Exchange Act Release No. 57649 (April 11,
2008), 73 FR 20976 (April 17, 2008) (File No. 4-551).
    \13\ See Securities Exchange Act Release No. 58765 (October 9,
2008), 73 FR 62344 (October 20, 2008) (File No. 4-551).
    \14\ See Securities Exchange Act Release No. 61588 (February 25,
2010), 75 FR 9970 (March 4, 2010) (File No. 4-551).
    \15\ See Securities Exchange Act Release No. 66975 (May 11,
2012), 77 FR 29712 (May 18, 2010) (File No. 4-551).
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    The Plan is designed to reduce regulatory duplication for common
members by allocating regulatory responsibility for certain options-
related market surveillance matters among the Participating
Organizations. Generally, under the Plan, a Participating Organization
will serve as the Designated Options Surveillance Regulator (``DOSR'')
for each common member assigned to it and will assume regulatory
responsibility with respect to that common member's compliance with
applicable common rules for certain accounts. When an SRO has been
named as a common member's DOSR, all other SROs to which the common
member belongs will be relieved of regulatory responsibility for that
common member, pursuant to the terms of the Plan, with respect to the
applicable common rules specified in Exhibit A to the Plan.

III. Proposed Amendment to the Plan

    On November 20, 2012, the parties submitted a proposed amendment to
the Plan. The primary purpose of the amendment is to add MIAX as a
Participant to the Plan. The amendment also reflects the name change of
the NYSE Amex LLC to NYSE MKT LLC. The text of the proposed amended
17d-2 plan is as follows (additions are italicized; deletions are
[bracketed]):
* * * * *

AGREEMENT BY AND AMONG NYSE MKT[AMEX] LLC, BATS EXCHANGE, INC., BOX
OPTIONS EXCHANGE LLC NASDAQ OMX BX, INC., C2 OPTIONS EXCHANGE,
INCORPORATED, THE CHICAGO BOARD OPTIONS EXCHANGE, INCORPORATED, THE
INTERNATIONAL SECURITIES EXCHANGE LLC, FINANCIAL INDUSTRY REGULATORY
AUTHORITY, INC., NYSE ARCA, INC., THE NASDAQ STOCK MARKET LLC, [AND
]NASDAQ OMX PHLX, INC., AND MIAMI INTERNATIONAL SECURITIES EXCHANGE,
LLC PURSUANT TO RULE 17d-2 UNDER THE SECURITIES EXCHANGE ACT OF 1934

    This agreement (this ``Agreement''), by and among [the ]NYSE
[Amex]MKT LLC (``[Amex]MKT''), BATS Exchange, Inc., (``BATS''), [the]C2
Options Exchange, Incorporated (``C2''), [the ]Chicago Board Options
Exchange, Incorporated (``CBOE''), [the]International Securities
Exchange LLC (``ISE''), Financial Industry Regulatory Authority, Inc.
(``FINRA''), NYSE Arca, Inc. (``Arca''), [The]NASDAQ Stock Market LLC
(``Nasdaq''), [the ]BOX Options Exchange LLC (``BOX''), NASDAQ OMX BX,
Inc. (``BX''), [and the ]NASDAQ OMX PHLX, Inc. (``PHLX''), and Miami
International Securities Exchange, LLC (``MIAX'') is made this 10th day
of October 2007, and as amended the 31st day of March 2008, the 1st day
of October 2008, the 3rd day of February 2010, [and ]the 25th day of
April 2012, and the 19th day of November 2012, pursuant to Section
17(d) of the Securities Exchange Act of 1934, as amended (the
``Exchange Act''), and Rule 17d-2 thereunder (``Rule 17d-2''), which
allows for a joint plan among self-regulatory organizations (``SROs'')
to allocate regulatory obligations with respect to brokers or dealers
that are members of two or more of the parties to this Agreement
(``Common Members''). The [Amex]MKT, BATS, C2, CBOE, ISE, FINRA, Arca,
Nasdaq, BOX, BX, [and ]PHLX, and MIAX are collectively referred to
herein as the ``Participants'' and individually, each a
``Participant.'' This Agreement shall be administered by a committee
known as the Options Surveillance Group (the ``OSG'' or ``Group''), as
described in Section V hereof. Unless defined in this Agreement or the
context otherwise requires, the terms used herein shall have the
meanings assigned thereto by the Exchange Act and the rules and
regulations thereunder.
    Whereas, the Participants desire to eliminate regulatory
duplication with respect to SRO market surveillance of Common Member
\1\ activities with regard to certain common rules relating to listed
options (``Options''); and
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    \1\ In the case of the BX and BOX, members are those persons who
are Options Participants (as defined in the BOX Options Exchange LLC
Rules and NASDAQ OMX BX, Inc. Rules).
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    Whereas, for this purpose, the Participants desire to execute and
file this Agreement with the Securities and Exchange Commission (the
``SEC'' or ``Commission'') pursuant to Rule 17d-2.
    Now, therefore, in consideration of the mutual covenants contained
in this Agreement, the Participants agree as follows:
    I. Except as otherwise provided in this Agreement, each Participant
shall assume Regulatory Responsibility (as

defined below) for the Common Members that are allocated or assigned to
such Participant in accordance with the terms of this Agreement and
shall be relieved of its Regulatory Responsibility as to the remaining
Common Members. For purposes of this Agreement, a Participant shall be
considered to be the Designated Options Surveillance Regulator
(``DOSR'') for each Common Member that is allocated to it in accordance
with Section VII.
    II. As used in this Agreement, the term ``Regulatory
Responsibility'' shall mean surveillance, investigation and enforcement
responsibilities relating to compliance by the Common Members with such
Options rules of the Participants as the Participants shall determine
are substantially similar and shall approve from time to time, insofar
as such rules relate to market surveillance (collectively, the ``Common
Rules''). For the purposes of this Agreement the list of Common Rules
is attached as Exhibit A hereto, which may only be amended upon
unanimous written agreement by the Participants. The DOSR assigned to
each Common Member shall assume Regulatory Responsibility with regard
to that Common Member's compliance with the applicable Common Rules for
certain accounts.\2\ A DOSR may perform its Regulatory Responsibility
or enter an agreement to transfer or assign such responsibilities to a
national securities exchange registered with the SEC under Section 6(a)
of the Exchange Act or a national securities association registered
with the SEC under Section 15A of the Exchange Act. A DOSR may not
transfer or assign its Regulatory Responsibility to an association
registered for the limited purpose of regulating the activities of
members who are registered as brokers or dealers in security futures
products.
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    \2\ Certain accounts shall include customer (``C'' as classified
by the Options Clearing Corporation (``OCC'')) and firm (``F'' as
classified by OCC) accounts, as well as other accounts, such as
market maker accounts as the Participants shall, from time to time,
identify as appropriate to review.
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    The term ``Regulatory Responsibility'' does not include, and each
Participant shall retain full responsibility with respect to:
    (a) Surveillance, investigative and enforcement responsibilities
other than those included in the definition of Regulatory
Responsibility;
    (b) any aspects of the rules of a Participant that are not
substantially similar to the Common Rules or that are allocated for a
separate surveillance purpose under any other agreement made pursuant
to Rule 17d-2. Any such aspects of a Common Rule will be noted as
excluded on Exhibit A.
    With respect to options position limits, the term Regulatory
Responsibility shall include examination responsibilities for the delta
hedging exemption. Specifically, the Participants intend that FINRA
will conduct examinations for delta hedging for all Common Members that
are members of FINRA notwithstanding the fact that FINRA's position
limit rule is, in some cases, limited to only firms that are not
members of an options exchange (i.e., access members). In such cases,
FINRA's examinations for delta hedging options position limit
violations will be for the identical or substantively similar position
limit rule(s) of the other Participant(s). Examinations for delta
hedging for Common Members that are non-FINRA members will be conducted
by the same Participant conducting position limit surveillance. The
allocation of Common Members to DOSRs for surveillance of compliance
with options position limits and other agreed to Common Rules is
provided in Exhibit B. The allocation of Common Members to DOSRs for
examinations of the delta hedging exemption under the options position
limits rules is provided in Exhibit C.
    III. Each year within 30 days of the anniversary date of the
commencement of operation of this Agreement, or more frequently if
required by changes in the rules of a Participant, each Participant
shall submit to the other Participants, through the Chair of the OSG,
an updated list of Common Rules for review. This updated list may add
Common Rules to Exhibit A, shall delete from Exhibit A rules of that
Participant that are no longer identical or substantially similar to
the Common Rules, and shall confirm that the remaining rules of the
Participant included on Exhibit A continue to be identically or
substantially similar to the Common Rules. Within 30 days from the date
that each Participant has received revisions to Exhibit A from the
Chair of the OSG, each Participant shall confirm in writing to the
Chair of the OSG whether that Participant's rules listed in Exhibit A
are Common Rules.
    IV. Apparent violation of another Participant's rules discovered by
a DOSR, but which rules are not within the scope of the discovering
DOSR's Regulatory Responsibility, shall be referred to the relevant
Participant for such action as is deemed appropriate by that
Participant.
    Notwithstanding the foregoing, nothing contained herein shall
preclude a DOSR in its discretion from requesting that another
Participant conduct an investigative or enforcement proceeding
(``Proceeding'') on a matter for which the requesting DOSR has
Regulatory Responsibility. If such other Participant agrees, the
Regulatory Responsibility in such case shall be deemed transferred to
the accepting Participant and confirmed in writing by the Participants
involved. Additionally, nothing in this Agreement shall prevent another
Participant on whose market potential violative activity took place
from conducting its own Proceeding on a matter. The Participant
conducting the Proceeding shall advise the assigned DOSR. Each
Participant agrees, upon request, to make available promptly all
relevant files, records and/or witnesses necessary to assist another
Participant in a Proceeding.
    V. The OSG shall be composed of one representative designated by
each of the Participants (a ``Representative''). Each Participant shall
also designate one or more persons as its alternate representative(s)
(an ``Alternate Representative''). In the absence of the
Representative, the Alternate Representative shall assume the powers,
duties and responsibilities of the Representative. Each Participant may
at any time replace its Representative and/or its Alternate
Representative to the Group.\3\ A majority of the OSG shall constitute
a quorum and, unless otherwise required, the affirmative vote of a
majority of the Representatives present (in person, by telephone or by
written consent) shall be necessary to constitute action by the Group.
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    \3\ A Participant must give notice to the Chair of the Group of
such a change.
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    The Group will have a Chair, Vice Chair and Secretary. A different
Participant will assume each position on a rotating basis for a one-
year term. In the event that a Participant replaces a Representative
who is acting as Chair, Vice Chair or Secretary, the newly appointed
Representative shall assume the position of Chair, Vice Chair, or
Secretary (as applicable) vacated by the Participant's former
Representative. In the event a Participant cannot fulfill its duties as
Chair, the Participant serving as Vice Chair shall substitute for the
Chair and complete the subject unfulfilled term. All notices and other
communications for the OSG are to be sent in care of the Chair and, as
appropriate, to each Representative.
    VI. The OSG shall determine the times and locations of Group
meetings, provided that the Chair, acting alone, may also call a
meeting of the Group in the event the Chair determines that there is
good cause to do so. To the extent reasonably possible, notice of any

meeting shall be given at least ten business days prior to the meeting
date. Representatives shall always be given the option of participating
in any meeting telephonically at their own expense rather than in
person.
    VII. No less frequently than every two years, in such manner as the
Group deems appropriate, the OSG shall allocate Common Members that
conduct an Options business among the Participants (``Allocation''),
and the Participant to which a Common Member is allocated will serve as
the DOSR for that Common Member. Any Allocation shall be based on the
following principles, except to the extent all affected Participants
consent to one or more different principles:
    (a) The OSG may not allocate a Common Member to a Participant
unless the Common Member is a member of that Participant.
    (b) To the extent practicable, Common Members that conduct an
Options business shall be allocated among the Participants of which
they are members in such manner as to equalize as nearly as possible
the allocation among such Participants, provided that no Common Members
shall be allocated to FINRA. For example, if sixteen Common Members
that conduct an Options business are members only of three
Participants, none of which is FINRA, those Common Members shall be
allocated among the three Participants such that no Participant is
allocated more than six such members and no Participant is allocated
less than five such members. If, in the previous example, one of the
three Participants is FINRA, the sixteen Common Members would be
allocated evenly between the remaining Participants, so that the two
non-FINRA Participants would be allocated eight Common Members each.
    (c) To the extent practicable, Allocation shall take into account
the amount of Options activity conducted by each Common Member in order
to most evenly divide the Common Members with the largest amount of
activity among the Participants of which they are members. Allocation
will also take into account similar allocations pursuant to other plans
or agreements to which the Common Members are party to maintain
consistency in oversight of the Common Members.\4\
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    \4\ For example, if one Participant was allocated a Common
Member by another regulatory group that Participant would be
assigned to be the DOSR of that Common Member, unless there is good
cause not to make that assignment.
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    (d) To the extent practicable, Allocation of Common Members to
Participants will be rotated among the applicable Participants such
that a Common Member shall not be allocated to a Participant to which
that Common Member was allocated within the previous two years. The
assignment of DOSRs pursuant to the Allocation is attached as Exhibit B
hereto, and will be updated from time to time to reflect Common Member
Allocation changes.
    (e) The Group may reallocate Common Members from time-to-time, as
it deems appropriate.
    (f) Whenever a Common Member ceases to be a member of its DOSR, the
DOSR shall promptly inform the Group, which shall review the matter and
allocate the Common Member to another Participant.
    (g) A DOSR may request that a Common Member to which it is assigned
be reallocated to another Participant by giving 30 days written notice
to the Chair of the OSG. The Group, in its discretion, may approve such
request and reallocate the Common Member to another Participant.
    (h) All determinations by the Group with respect to Allocation
shall be made by the affirmative vote of a majority of the Participants
that, at the time of such determination, share the applicable Common
Member being allocated; a Participant shall not be entitled to vote on
any Allocation relating to a Common Member unless the Common Member is
a member of such Participant.
    VIII. Each DOSR shall conduct routine surveillance reviews to
detect violations of the applicable Common Rules by each Common Member
allocated to it with a frequency (daily, weekly, monthly, quarterly,
semi-annually or annually as noted on Exhibit A) not less than that
determined by the Group. The other Participants agree that, upon
request, relevant information in their respective files relative to a
Common Member will be made available to the applicable DOSR. In
addition, each Participant shall provide, to the extent not otherwise
already provided, information pertaining to its surveillance program
that would be relevant to FINRA or the Participant(s) conducting
routine examinations for the delta hedging exemption.
    At each meeting of the OSG, each Participant shall be prepared to
report on the status of its surveillance program for the previous
quarter and any period prior thereto that has not previously been
reported to the Group. In the event a DOSR believes it will not be able
to complete its Regulatory Responsibility for its allocated Common
Members, it will so advise the Group in writing promptly. The Group
will undertake to remedy this situation by reallocating the subject
Common Members among the remaining Participants. In such instance, the
Group may determine to impose a regulatory fee for services provided to
the DOSR that was unable to fulfill its Regulatory Responsibility.
    IX. Each Participant will, upon request, promptly furnish a copy of
the report or applicable portions thereof relating to any investigation
made pursuant to the provisions of this Agreement to each other
Participant of which the Common Member under investigation is a member.
    X. Each Participant will routinely populate a common database, to
be accessed by the Group relating to any formal regulatory action taken
during the course of a Proceeding with respect to the Common Rules
concerning a Common Member.
    XI. Any written notice required or permitted to be given under this
Agreement shall be deemed given if sent by certified mail, return
receipt requested, to any Participant to the attention of that
Participant's Representative, to the Participant's principal place of
business or by email at such address as the Representative shall have
filed in writing with the Chair.
    XII. The costs incurred by each Participant in discharging its
Regulatory Responsibility under this Agreement are not reimbursable.
However, any of the Participants may agree that one or more will
compensate the other(s) for costs incurred.
    XIII. The Participants shall notify the Common Members of this
Agreement by means of a uniform joint notice approved by the Group.
Each Participant will notify the Common Members that have been
allocated to it that such Participant will serve as DOSR for that
Common Member.
    XIV. This Agreement shall be effective upon approval of the
Commission. This Agreement may only be amended in writing duly approved
by each Participant. All amendments to this Agreement, excluding
changes to Exhibits A, B and C, must be filed with and approved by the
Commission.
    XV. Any Participant may manifest its intention to cancel its
participation in this Agreement at any time upon providing written
notice to (i) the Group six months prior to the date of such
cancellation, or such other period as all the Participants may agree,
and (ii) the Commission. Upon receipt of the notice the Group shall
allocate, in accordance with the provisions of this Agreement, those
Common Members for which the canceling Participant was the DOSR. The
canceling Participant shall retain its Regulatory Responsibility and
other rights, privileges and duties pursuant to this Agreement until
the Group has

completed the reallocation as described above, and the Commission has
approved the cancellation.
    XVI. The cancellation of its participation in this Agreement by any
Participant shall not terminate this Agreement as to the remaining
Participants. This Agreement will only terminate following notice to
the Commission, in writing, by the then Participants that they intend
to terminate the Agreement and the expiration of the applicable notice
period. Such notice shall be given at least six months prior to the
intended date of termination, or such other period as all the
Participants may agree. Such termination will become effective upon
Commission approval.
    XVII. Participation in the Group shall be strictly limited to the
Participants and no other party shall have any right to attend or
otherwise participate in the Group except with the unanimous approval
of all Participants. Notwithstanding the foregoing, any national
securities exchange registered with the SEC under Section 6(a) of the
Act or any national securities association registered with the SEC
under section 15A of the Act may become a Participant to this Agreement
provided that: (i) Such applicant has adopted rules substantially
similar to the Common Rules, and received approval thereof from the
SEC; (ii) such applicant has provided each Participant with a signed
statement whereby the applicant agrees to be bound by the terms of this
Agreement to the same effect as though it had originally signed this
Agreement and (iii) an amended agreement reflecting the addition of
such applicant as a Participant has been filed with and approved by the
Commission.
    XVIII. This Agreement is wholly separate from the multiparty
Agreement made pursuant to Rule 17d-2 by and among the NYSE MKT
LLC[American Stock Exchange, LLC], the Boston Stock Exchange, Inc., the
Chicago Board Options Exchange, Inc., the International Securities
Exchange, LLC, Financial Industry Regulatory Authority, The NASDAQ
Stock Market LLC, Inc., the New York Stock Exchange, LLC, the NYSE
Arca, Inc., [and ]the Philadelphia Stock Exchange, Inc., and Miami
International Securities Exchange, LLC involving the allocation of
regulatory responsibilities with respect to common members for
compliance with common rules relating to the conduct by broker-dealers
of accounts for listed options or index warrants entered into on June
5, 2008, and as may be amended from time to time.

Limitation of Liability

    No Participant nor the Group nor any of their respective directors,
governors, officers, employees or representatives shall be liable to
any other Participant in this Agreement for any liability, loss or
damage resulting from or claimed to have resulted from any delays,
inaccuracies, errors or omissions with respect to the provision of
Regulatory Responsibility as provided hereby or for the failure to
provide any such Regulatory Responsibility, except with respect to such
liability, loss or damages as shall have been suffered by one or more
of the Participants and caused by the willful misconduct of one or more
of the other Participants or its respective directors, governors,
officers, employees or representatives. No warranties, express or
implied, are made by the Participants, individually or as a group, or
by the OSG with respect to any Regulatory Responsibility to be
performed hereunder.

Relief From Responsibility

    Pursuant to Section 17(d)(1)(A) of the Exchange Act and Rule 17d-2,
the Participants join in requesting the Commission, upon its approval
of this Agreement or any part thereof, to relieve the Participants that
are party to this Agreement and are not the DOSR as to a Common Member
of any and all Regulatory Responsibility with respect to the matters
allocated to the DOSR.

    Violation I--Expiring Exercise Declarations (EED)--For Listed Equity Options Expiring: The Third Saturday
                  Following the Third Friday of A Month, Quarterly, and for Listed FLEX Options
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               SRO                    Description of rule         Exchange Rule No.        Frequency  of review
----------------------------------------------------------------------------------------------------------------
BATS.............................  Exercise of Options        Rule 23.1................  At Expiration.
                                    Contracts.
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BOX..............................  Exercise of Options        Rule 9000................  At Expiration.
                                    Contracts.
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C2...............................  Exercise of Options        Rule 11.1................  At Expiration.
                                    Contracts.
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CBOE.............................  Exercise of Options        Rule 11.1................  At Expiration.
                                    Contracts.
----------------------------------------------------------------------------------------------------------------
FINRA............................  Exercise of Options        Rule 2360(b)(23).........  At Expiration.
                                    Contracts.
----------------------------------------------------------------------------------------------------------------
ISE..............................  Exercise of Options        Rule 1100................  At Expiration.
                                    Contracts.
----------------------------------------------------------------------------------------------------------------
MIAX.............................  Exercise of Options        Rule 700.................  At Expiration.
                                    Contracts.
----------------------------------------------------------------------------------------------------------------
Nasdaq...........................  Exercise of Options        Nasdaq Chapter VIII, Sec.  At Expiration.
                                    Contracts.                 1.
----------------------------------------------------------------------------------------------------------------
NYSE Arca........................  Exercise of Options        Rule 6.24................  At Expiration.
                                    Contracts.
----------------------------------------------------------------------------------------------------------------
NYSE [Amex]MKT...................  Exercise of Options        Rule 980.................  At Expiration.
                                    Contracts.
----------------------------------------------------------------------------------------------------------------
NASDAQ OMX BX....................  Exercise of Options        Chapter VII, Section 1...  At Expiration.
                                    Contracts.
----------------------------------------------------------------------------------------------------------------
NASDAQ OMX PHLX..................  Exercise of Equity         Rule 1042................  At Expiration.
                                    Options Contracts.
----------------------------------------------------------------------------------------------------------------

 Violation II--Position Limits (PL)--For Listed Equity Options Expiring: The Third Saturday Following The Third
                                          Friday of A Month, Quarterly
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                                    Description of rule (for
               SRO                  review as they apply to       Exchange rule No.        Frequency  of review
                                              PL)
----------------------------------------------------------------------------------------------------------------
BATS.............................  Position Limits..........  Rule 18.7................  Daily.
                                   Exemptions from Position.  Rule 18.8................  As Needed.
                                   Liquidating Positions....  Rule 18.11...............  As Needed.
----------------------------------------------------------------------------------------------------------------
BOX..............................  Position Limits..........  Rule 3120................  Daily.
                                   Exemptions from Position.  Rule 3130................  As Needed.
                                   Liquidating Positions....  Rule 3160................  As Needed.
----------------------------------------------------------------------------------------------------------------
C2...............................  Position Limits..........  Rule 4.11................  Daily.
                                   Liquidating Positions....  Rule 4.14................  As Needed.
----------------------------------------------------------------------------------------------------------------
CBOE.............................  Position Limits..........  Rule 4.11................  Daily.
                                   Liquidating Positions....  Rule 4.14................  As Needed.
----------------------------------------------------------------------------------------------------------------
FINRA............................  Position Limits..........  Rule 2360(b)(3)..........  Daily.
                                   Liquidation of Positions   Rule 2360(b)(6)..........  As Needed.
                                    and Restrictions on
                                    Access.
----------------------------------------------------------------------------------------------------------------
ISE..............................  Position Limits..........  Rule 412.................  Daily.
                                   Exemptions from Position   Rule 413.................  As Needed.
                                    Limits.
                                   Liquidating Positions....  Rule 416.................  As Needed.
----------------------------------------------------------------------------------------------------------------
MIAX.............................  Position Limits..........  Rule 307.................  Daily.
                                   Exemptions from Position   Rule 308.................  As Needed.
                                    Limits.
                                   Liquidating Positions....  Rule 311.................  As Needed.
----------------------------------------------------------------------------------------------------------------
Nasdaq...........................  Position Limits..........  [Nasdaq Rule] Chapter      Daily.
                                                               III, Section 7.
                                   Exemptions from Position   [Nasdaq Rule] Chapter      As Needed.
                                    Limits.                    III, Section 8.
                                   Liquidating Positions....  [Nasdaq Rule] Chapter      As Needed.
                                                               III, Section 11.
----------------------------------------------------------------------------------------------------------------
NYSE Arca........................  Position Limits..........  Rule 6.8.................  Daily.
                                   Liquidation of Positions.  Rule 6.7.................  As Needed.
----------------------------------------------------------------------------------------------------------------
NYSE [Amex] MKT..................  Position Limits..........  Rule 904.................  Daily.
                                   Liquidating Positions....  Rule 907.................  As Needed.
----------------------------------------------------------------------------------------------------------------
NASDAQ OMX BX....................  Position Limits..........  Chapter III, Section 7...  Daily.
                                   Exemptions from Position   Chapter III, Section 8...  As Needed.
                                    Limits.
                                   Liquidating Positions....  Chapter III, Section 11..  As Needed.
----------------------------------------------------------------------------------------------------------------
NASDAQ OMX PHLX..................  Position Limits..........  Rule 1001................  Daily.
                                   Liquidation of Positions.  Rule 1004................  As Needed.
----------------------------------------------------------------------------------------------------------------

              Violation III--Large Option Position Report (LOPR)--For Listed Equity and ETF Options
----------------------------------------------------------------------------------------------------------------
                                    Description of rule (for
               SRO                  review as they apply to       Exchange Rule No.        Frequency  of review
                                             LOPR)
----------------------------------------------------------------------------------------------------------------
BATS.............................  Reports Related to         Rule 18.10...............  Yearly.
                                    Position Limits.
----------------------------------------------------------------------------------------------------------------
BOX..............................  Reports Related to         Rule 3150................  Yearly.
                                    Position Limits.
----------------------------------------------------------------------------------------------------------------
C2...............................  Reports Related to         Rule 4.13(a).............  Yearly.
                                    Position Limits.
                                   Reports Related to         Rule 4.13(b).............  Yearly.
                                    Position Limits.
                                   Reports Related to         Rule 4.13(d).............  Yearly.
                                    Position Limits.
----------------------------------------------------------------------------------------------------------------
CBOE.............................  Reports Related to         Rule 4.13(a).............  Yearly.
                                    Position Limits.
                                   Reports Related to         Rule 4.13(b).............  Yearly.
                                    Position Limits.
                                   Reports Related to         Rule 4.13(d).............  Yearly.
                                    Position Limits.
----------------------------------------------------------------------------------------------------------------
FINRA............................  Options..................  Rule 2360(b)(5)..........  Yearly.
----------------------------------------------------------------------------------------------------------------
ISE..............................  Reports Related to         Rule 415.................  Yearly.
                                    Position Limits.
----------------------------------------------------------------------------------------------------------------
MIAX.............................  Reports Related to         Rule 310.................  Yearly.
                                    Position Limits.
----------------------------------------------------------------------------------------------------------------
Nasdaq...........................  Reports Related to         Chapter III, Section 10..  Yearly.
                                    Position Limits.
----------------------------------------------------------------------------------------------------------------
NYSE Arca........................  Reporting of Options       Rule 6.6.................  Yearly.
                                    Positions.
----------------------------------------------------------------------------------------------------------------

NYSE [Amex] MKT..................  Reporting of Options       Rule 906.................  Yearly.
                                    Positions.
----------------------------------------------------------------------------------------------------------------
Nasdaq OMX BX....................  Reports Related to         Chapter III, Section 10..  Yearly.
                                    Position Limits.
----------------------------------------------------------------------------------------------------------------
NASDAQ OMX PHLX..................  Reporting of Options       Rule 1003................  Yearly.
                                    Positions.
----------------------------------------------------------------------------------------------------------------

                       Violation IV--Options Clearing Corporation (OCC) Adjustment Process
----------------------------------------------------------------------------------------------------------------
                                    Description of Rule (as
                                       they apply to OCC
               SRO                    Adjustments/By-Laws         Exchange Rule No.        Frequency  of review
                                       Article V, Section
                                        1.01(a) and .02)
----------------------------------------------------------------------------------------------------------------
BATS.............................  Adherence to Law.........  Rule 18.1................  Yearly.
----------------------------------------------------------------------------------------------------------------
BOX..............................  Adherence to Law.........  Rule 3010................  Yearly.
----------------------------------------------------------------------------------------------------------------
C2...............................  Adherence to Law.........  Rule 4.2.................  Yearly.
----------------------------------------------------------------------------------------------------------------
CBOE.............................  Adherence to Law.........  Rule 4.2.................  Yearly.
----------------------------------------------------------------------------------------------------------------
FINRA............................  Violation of By-Laws and   Rule2360(b)(21)..........  Yearly.
                                    Rules of FINRA or the
                                    OCC.
----------------------------------------------------------------------------------------------------------------
ISE..............................  Adherence to Law.........  Rule 401.................  Yearly.
----------------------------------------------------------------------------------------------------------------
MIAX.............................  Adherence to Law.........  Rule 300.................  Yearly.
----------------------------------------------------------------------------------------------------------------
Nasdaq...........................  Adherence to Law.........  Chapter III, Section 1...  Yearly.
----------------------------------------------------------------------------------------------------------------
NYSE Arca........................  Adherence to Law and Good  Rule 11.1................  Yearly.
                                    Business Practice.
----------------------------------------------------------------------------------------------------------------
NYSE [Amex]MKT...................  Business Conduct.........  Rule 16..................  Yearly.
----------------------------------------------------------------------------------------------------------------
NASDAQ OMX BX....................  Adherence to Law.........  Chapter III, Section 1...  Yearly.
----------------------------------------------------------------------------------------------------------------
NASDAQ OMX PHLX..................  Violation of By-Laws and   Rule 1050................  Yearly.
                                    Rules of OCC.
----------------------------------------------------------------------------------------------------------------

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number 4-551 on the subject line.

Paper Comments

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

All submissions should refer to File Number 4-551. This file number
should be included on the subject line if email is used. To help the
Commission process and review your comments more efficiently, please
use only one method. The Commission will post all comments on the
Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml).
Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed plan that are filed with the
Commission, and all written communications relating to the proposed
plan between the Commission and any person, other than those that may
be withheld from the public in accordance with the provisions of 5
U.S.C. 552, will be available for Web site viewing and printing in the
Commission's Public Reference Room, 100 F Street NE., Washington, DC
20549, on official business days between the hours of 10:00 a.m. and
3:00 p.m. Copies of the plan also will be available for inspection and
copying at the principal offices of MKT, BATS, C2, CBOE, ISE, FINRA,
Arca, NASDAQ, BOX, BX, Phlx and MIAX. All comments received will be
posted without change; the Commission does not edit personal
identifying information from submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File Number 4-551 and should be submitted on or before
January 2, 2013.

V. Discussion

    The Commission continues to believe that the Plan, as proposed to
be amended, is an achievement in cooperation among the SRO
participants. The Plan, as amended, will reduce unnecessary regulatory
duplication by allocating to the designated SRO the responsibility for
certain options-related market surveillance matters that would
otherwise be performed by multiple SROs. The Plan promotes efficiency
by reducing costs to firms that are members of more than one of the SRO
participants. In addition, because the SRO participants coordinate
their regulatory functions in accordance with the Plan, the Plan
promotes, and will continue to promote, investor protection. Under
paragraph (c) of Rule 17d-2, the Commission may, after appropriate
notice and comment, declare a plan, or any part of a plan,

effective. In this instance, the Commission believes that appropriate
notice and comment can take place after the proposed amendment is
effective. The primary purpose of the amendment is to add MIAX as a
Participant to the Plan. By declaring it effective today, the amended
Plan can become effective and be implemented without undue delay.\16\
In addition, the Commission notes that the prior version of this Plan
was published for comment, and the Commission did not receive any
comments thereon.\17\ Finally, the Commission does not believe that the
amendment to the Plan raises any new regulatory issues that the
Commission has not previously considered.
---------------------------------------------------------------------------

    \16\ On December 3, 2012, the Commission granted MIAX's
application for registration as a national securities exchange. See
Securities Exchange Act Release No. 68341 (File No. 10-207).
    \17\ See supra note 15 (citing to Securities Exchange Act
Release No. 66975).
---------------------------------------------------------------------------

VI. Conclusion

    This order gives effect to the amended Plan submitted to the
Commission that is contained in File No. 4-551.
    It is therefore ordered, pursuant to Section 17(d) of the Act, that
the Plan, as amended by and between MKT, BATS, C2, CBOE, ISE, FINRA,
Arca, NASDAQ, BOX, BX, Phlx and MIAX, filed with the Commission
pursuant to Rule 17d-2 on November 20, 2012 is hereby approved and
declared effective.
    It is further ordered that those SRO participants that are not the
DOSR as to a particular common member are relieved of those regulatory
responsibilities allocated to the common member's DOSR under the
amended Plan to the extent of such allocation.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\18\
---------------------------------------------------------------------------

    \18\ 17 CFR 200.30-3(a)(34).
---------------------------------------------------------------------------

Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2012-29842 Filed 12-10-12; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 80, Number 195 (Thursday, October 8, 2015)]
[Notices]
[Pages 60916-60917]
[FR Doc No: 2015-25630]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-D-0449]

Integrated Summary of Effectiveness; Guidance for Industry;
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a guidance for industry entitled ``Integrated
Summary of Effectiveness.'' This guidance describes how an integrated
summary of effectiveness (ISE) should be prepared by industry for new
drug applications (NDAs) and biologics license applications (BLAs).
This guidance is intended to improve the quality of drug applications
by describing what efficacy information should be submitted so that FDA
can make a regulatory decision on an application. This guidance
finalizes the draft guidance issued August 28, 2008.

DATES: Submit either electronic or written comments on Agency guidances
at any time.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2008-D-0449 for Integrated Summary of Effectiveness; Guidance for
Industry; Availability. Received comments will be placed in the docket
and, except for those submitted as ``Confidential Submissions,''
publicly viewable at http://www.regulations.gov or at the Division of
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
    Submit written requests for single copies of this guidance to the
Division of Drug Information, Center for Drug Evaluation and Research,
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale
Building, 4th Floor, Silver Spring, MD 20993-0002; or the Office of
Communication, Training, and Manufacturers Assistance, Center for
Biologics Evaluation and Research, 10903 New Hampshire Ave., Bldg. 71,
Rm. 3128, Silver Spring, MD 20993-0002. The guidance may also be
obtained from the Center for Biologics Evaluation and Research by mail
by calling 1-800-835-4709 or<PHONE_NUMBER>. Send one self-addressed
adhesive label to assist that office in processing your requests. See
the SUPPLEMENTARY INFORMATION section for electronic access to the
guidance document.

FOR FURTHER INFORMATION CONTACT: Helen Sile, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 22, Rm. 6462, Silver Spring, MD 20993-0002,<PHONE_NUMBER>; or
Stephen Ripley, Center for Biologics Evaluation and Research, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry
entitled ``Integrated Summary of Effectiveness.'' This guidance
describes how an ISE should be prepared by industry for NDAs and BLAs.
The ISE has been required as part of an NDA submission since 1985 (21
CFR 314.50(d)(5)(v)), but the regulation does not describe the specific
components of the ISE. The guidance for industry ``Guideline for the
Format and Content of the Clinical and Statistical Sections of an
Application'' (Clin-Stat guidance) provides a description of what FDA
recommends for inclusion in an ISE. However, since the Clin-Stat
guidance was published, several International Conference on
Harmonisation guidances, including the ICH guidances for industry ``E3
Structure and Content of Clinical Study Reports,'' ``E10 Choice of
Control Group and Related Issues in Clinical Trials,'' and ``M4E The
CTD--Efficacy,'' have

provided additional recommendations for describing individual trials
and providing results of efficacy analyses.
    This guidance supersedes section II.G., Integrated Summary of
Effectiveness Data, of the Clin-Stat guidance to reflect FDA's current
thinking regarding the format and content of the ISE to provide a truly
integrated analysis, rather than a summary of efficacy results from
individual clinical trials, and to satisfy FDA regulatory requirements.
This guidance also incorporates the conceptual framework of section
2.7.3, Summary of Clinical Efficacy, from ICH M4E. Although there are
no corresponding regulations requiring an ISE for BLA submissions,
applicants are encouraged to provide these analyses.
    The focus of the ISE is not on the detailed results of individual
studies, which are described in individual study reports, but a
comprehensive, detailed, integrated analysis that goes beyond
individual study results to examine all sources of information
concerning effectiveness to provide further insight into the efficacy
of the study drug. Integrated analyses included in an ISE generally
fall into two broad categories: (1) Comparing the individual studies to
better understand the overall results; and (2) using the greater power
of pooled analyses to gain insight into the nature of the drug's
effectiveness in demographic (e.g., age, sex, race, and ethnicity) and
other subpopulations, dose-response, and onset and duration of effect,
among others.
    A draft of this guidance was published for comment in the Federal
Register on August 28, 2008 (73 FR 50825). Comments received on the
draft guidance have been considered and the guidance has been revised
as follows: (1) Clarification on the difference between the document
included in Module 2, section 2.7.3, Summary of Clinical Efficacy, from
ICH M4E, and the ISE has been provided; (2) the definition of
integrated analyses has been revised and the components that constitute
an integrated analyses have been clarified; (3) pooled analyses has
been defined; and (4) the recommendations for when it is appropriate to
pool data has been included.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on preparing an ISE. It does not establish any
rights for any person and is not binding on FDA or the public. You can
use an alternative approach if it satisfies the requirements of the
applicable statutes and regulations.

II. The Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of
information that are subject to review by the Office of Management and
Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520). The collections of information in 21 CFR part 314 have been
approved under OMB control number 0910-0001. The collections of
information for submission of data in a BLA under 21 CFR 601.2 have
been approved under OMB control number 0910-0338.

III. Electronic Access

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

    Dated: October 2, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-25630 Filed 10-7-15; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register: May 1, 2008 (Volume 73, Number 85)]
[Notices]
[Page 24080]
[DOCID:fr01my08-62]

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

DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[FEMA-1749-DR]

Missouri; Amendment No. 4 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: This notice amends the notice of a major disaster declaration
for the State of Missouri (FEMA-1749-DR), dated March 19, 2008, and
related determinations.

DATES: Effective Date: April 23, 2008.

FOR FURTHER INFORMATION CONTACT: Peggy Miller, Disaster Assistance
Directorate, Federal Emergency Management Agency, 500 C Street, SW.,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The notice of a major disaster declaration
for the State of Missouri is hereby amended to include the following
areas among those areas determined to have been adversely affected by
the catastrophe declared a major disaster by the President in his
declaration of March 19, 2008.

    Douglas and Ozark Counties for Public Assistance (already
designated for emergency protective measures [Category B], limited
to direct Federal assistance, under the Public Assistance program.)

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

R. David Paulison,
Administrator, Federal Emergency Management Agency.
 [FR Doc. E8-9530 Filed 4-30-08; 8:45 am]

BILLING CODE 9110-10-P


[Federal Register Volume 80, Number 32 (Wednesday, February 18, 2015)]
[Notices]
[Pages 8639-8640]
[FR Doc No: 2015-03293]

=======================================================================
-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

[FRL-9923-30-OEI]

Agency Information Collection Activities OMB Responses

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: This document announces the Office of Management and Budget
(OMB) responses to Agency Clearance requests, in compliance with the
Paperwork Reduction Act (44 U.S.C. 3501 et seq.). An agency may not
conduct or sponsor, and a person is not required to respond to, a
collection of information unless it displays a currently valid OMB
control number. The OMB control numbers for EPA regulations are listed
in 40 CFR part 9 and 48 CFR chapter 15.

FOR FURTHER INFORMATION CONTACT: Courtney Kerwin<PHONE_NUMBER>, or
email at<EMAIL_ADDRESS>and please refer to the appropriate
EPA Information Collection Request (ICR) Number.

SUPPLEMENTARY INFORMATION:

OMB Responses to Agency Clearance Requests

OMB Approvals

    EPA ICR Number 1564.09; NSPS for Small Industrial-Commercial-
Institutional Steam Generating Units (Renewal); 40 CFR part 60,
subparts A and Dc; approved with change on 12/30/2014; OMB Number 2060-
0202; expires on 12/31/2017.
    EPA ICR Number 1053.11; NSPS for Electric Utility Steam Generating
Units (Renewal); 40 CFR part 60, subparts A and Da; approved without
change on 12/30/2014; OMB Number 2060-0023; expires on 12/31/2017.

    EPA ICR Number 1626.12; National Refrigerant Recycling and
Emissions Reduction Program (Renewal); was approved with change on 12/
23/2014; OMB Number 2060-0256; expires on 12/23/2017.
    EPA ICR Number 2473.02; RFS2 Voluntary RIN Quality Assurance
Program (Final Rule); approved with change on 12/01/2014; OMB Control
Number 2060-0688.

Courtney Kerwin,
Acting Director, Collections Strategies Division.
[FR Doc. 2015-03293 Filed 2-17-15; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 84, Number 65 (Thursday, April 4, 2019)]
[Notices]
[Pages 13286-13287]
[FR Doc No: 2019-06617]

=======================================================================
-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-ORD-2018-0655; FRL-9991-57-ORD]

Availability of the IRIS Assessment Plan for Methylmercury

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of public comment period.

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

SUMMARY: The Environmental Protection Agency (EPA) is announcing a 30-
day public comment period associated with release of the draft IRIS
Assessment Plan for Methylmercury. This document communicates
information on the scoping needs identified by EPA program and regional
offices and the IRIS Program's initial problem formulation activities.
Specifically, the assessment plan outlines the objectives for each
assessment and the type of evidence considered most pertinent to
address the scoping needs. EPA is releasing this draft IRIS Assessment
Plan for a 30-day public comment period in advance of a public science
webinar planned for May 15, 2019. The Agency encourages the public to
comment on all aspects of the assessment plan, including key science
issues.

DATES: The 30-day public comment period begins April 4, 2019 and ends
May 6, 2019. Comments must be received on or before May 6, 2019.

ADDRESSES: The draft IRIS Assessment Plan for Methylmercury will be
available via the internet on the IRIS website at https://www.epa.gov/iris/iris-recent-additions and in the public docket at http://www.regulations.gov, Docket ID No. EPA-HQ-ORD-2018-0655.

FOR FURTHER INFORMATION CONTACT: For information on the public comment
period, contact the ORD Docket at the EPA Headquarters Docket Center;
telephone:<PHONE_NUMBER>; facsimile:<PHONE_NUMBER>; or email:
[email protected].
    For technical information on the draft IRIS Assessment Plan for
Methylmercury, contact Dr. James Avery, NCEA; telephone:<PHONE_NUMBER>;
or email: [email protected].

SUPPLEMENTARY INFORMATION:

I. Information About IRIS Assessment Plans

    EPA's IRIS Program is a human health assessment program that
evaluates quantitative and qualitative information on the health
effects that may result from exposure to chemicals found in the
environment. Through the IRIS Program, EPA provides high quality
science-based human health assessments to support the Agency's
regulatory activities and decisions to protect public health. As part
of scoping and initial problem formulation activities prior to the
development of a draft assessment, the IRIS Program carries out a
broad, preliminary literature survey to assist in identifying health
effects that have been studied in relation to the chemical or substance
of interest, as well as science issues that may need to be considered
when evaluating toxicity. This information, in conjunction with scoping
needs identified by EPA program and regional offices, is used to inform
the development of an IRIS Assessment Plan (IAP).
    The IAP communicates the plan for developing each individual
chemical assessment to the public and includes summary information on
the IRIS Program's scoping and initial problem formulation, objectives
and specific aims for the assessment, and a PECO (Populations,
Exposures, Comparators, and Outcomes) for the systematic review. The
PECO provides the framework for developing detailed literature search
strategies and inclusion/exclusion criteria, particularly with respect
to evidence stream (e.g., human, animal, mechanistic), exposure
measures, and outcome measures. The IAP serves to inform the subsequent
development of chemical-specific systematic review protocols, which
will be made available for public review.

II. Public Webinar Information

    To allow for public input, EPA is convening a public webinar to
discuss the draft IRIS Assessment Plan for Methylmercury on May 15,
2019. Specific teleconference and webinar information regarding this
public meeting will be provided through the IRIS website (https://www.epa.gov/iris) and via EPA's Human Health Risk Assessment (HHRA) and
IRIS listservs. To register for the HHRA or IRIS listserv, visit the
IRIS website (https://www.epa.gov/iris) or visit https://www.epa.gov/iris/forms/staying-connected-integrated-risk-information-system#connect.

III. How To Submit Technical Comments to the Docket at http://www.regulations.gov

    Submit your comments, identified by Docket ID No. EPA-HQ-ORD-2018-
0655 for Methylmercury, by one of the following methods:
     www.regulations.gov: Follow the on-line instructions for
submitting comments.
     Email: [email protected].
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Environmental Protection Agency, EPA Docket
Center (ORD Docket), Mail Code: 28221T, 1200 Pennsylvania Avenue NW,
Washington, DC 20460. The phone number is<PHONE_NUMBER>.
     Hand Delivery: The ORD Docket is located in the EPA
Headquarters Docket Center, EPA West Building, Room 3334, 1301
Constitution Avenue NW, Washington, DC 20004.

The EPA Docket Center Public Reading Room is open from 8:30 a.m. to
4:30 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the Public Reading Room is<PHONE_NUMBER>.
Deliveries are only accepted during the docket's normal hours of

operation, and special arrangements should be made for deliveries of
boxed information. If you provide comments by mail or hand delivery,
please submit three copies of the comments. For attachments, provide an
index, number pages consecutively with the comments, and submit an
unbound original and three copies.
    Instructions: Direct your comments to Docket ID No. EPA-HQ-ORD-
2018-0655 for Methylmercury. Please ensure that your comments are
submitted within the specified comment period. Comments received after
the closing date will be marked ``late,'' and may only be considered if
time permits. It is EPA's policy to include all comments it receives in
the public docket without change and to make the comments available
online at www.regulations.gov, including any personal information
provided, unless a comment includes information claimed to be
Confidential Business Information (CBI) or other information for which
disclosure is restricted by statute. Do not submit information through
www.regulations.gov or email that you consider to be CBI or otherwise
protected. The www.regulations.gov website is an ``anonymous access''
system, which means EPA will not know your identity or contact
information unless you provide it in the body of your comment. If you
send an email comment directly to EPA without going through
www.regulations.gov, your email address will be automatically captured
and included as part of the comment that is placed in the public docket
and made available on the internet. If you submit an electronic
comment, EPA recommends that you include your name and other contact
information in the body of your comment and with any disk or CD-ROM you
submit. If EPA cannot read your comment due to technical difficulties
and cannot contact you for clarification, EPA may not be able to
consider your comment. Electronic files should avoid the use of special
characters, any form of encryption, and be free of any defects or
viruses. For additional information about EPA's public docket visit the
EPA Docket Center homepage at www.epa.gov/epahome/dockets.htm.
    Docket: Documents in the docket are listed in the
www.regulations.gov index. Although listed in the index, some
information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other materials,
such as copyrighted material, are publicly available only in hard copy.
Publicly available docket materials are available either electronically
in www.regulations.gov or in hard copy at the ORD Docket in the EPA
Headquarters Docket Center.

    Dated: March 26, 2019.
Mary Ross,
Deputy Director, National Center for Environmental Assessment.
[FR Doc. 2019-06617 Filed 4-3-19; 8:45 am]
 BILLING CODE 6560-50-P