[Federal Register Volume 85, Number 9 (Tuesday, January 14, 2020)]
[Notices]
[Pages 2212-2218]
[FR Doc No: 2020-00358]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-87910; File No. S7-24-89]

Joint Industry Plan; Notice of Filing of the Forty-Seventh
Amendment to the Joint Self-Regulatory Organization Plan Governing the
Collection, Consolidation and Dissemination of Quotation and
Transaction Information for Nasdaq-Listed Securities Traded on
Exchanges on an Unlisted Trading Privileges Basis

January 8, 2020.
    Pursuant to Section 11A of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 608 of Regulation National Market System
(``NMS'') thereunder,\2\ notice is hereby given that on November 25,
2019,\3\ the Participants \4\ in the Joint Self-

Regulatory Organization Plan Governing the Collection, Consolidation
and Dissemination of Quotation and Transaction Information for Nasdaq-
Listed Securities Traded on Exchanges on an Unlisted Trading Privileges
Basis (``Nasdaq/UTP Plan'' or ``Plan'') filed with the Securities and
Exchange Commission (``SEC'' or ``Commission'') a proposal to amend the
Nasdaq/UTP Plan.\5\ The amendment represents the Forty-Seventh
Amendment to the Plan (``Amendment''). As described in the Amendment,
the Participants propose to adopt a confidentiality policy to provide
guidelines for the Operating Committee and the Advisory Committee of
the Plan, and all subcommittees thereof, regarding the confidentiality
of any data or information generated, accessed, or transmitted to the
Operating Committee, as well as discussions occurring at a meeting of
the Operating Committee or any subcommittee. According to the
Participants, the confidentiality policy is designed broadly (i) to
protect against any potential misuse of confidential information, which
includes, but is not limited to, protecting confidential information
obtained or generated by the Administrator and Processor in connection
with the operation of the Plan as well as (ii) to allow the Operating
Committee to disclose confidential information to the Advisory
Committee to obtain its input without concern that such confidential
information may be shared beyond the Advisory Committee. The
Participants believe that the proposed Amendment will allow for more
sharing of information with the Advisory Committee regarding the
operation of the Plan and elicit more input by the Advisory Committee
on Plan matters that might otherwise be deemed confidential.\6\
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    \1\ 15 U.S.C. 78k-1(a)(3).
    \2\ 17 CFR 242.608.
    \3\ See Letter from Robert Books, Chairman, Operating Committee,
Nasdaq/UTP Plan, to Vanessa Countryman, Secretary, Commission, dated
November 19, 2019 (``Transmittal Letter'').
    \4\ The Participants are the national securities association and
national securities exchanges that submit trades and quotes to the
Plan and include: Cboe BYX Exchange, Inc., Cboe BZX Exchange, Inc.,
Cboe EDGA Exchange, Inc., Cboe EDGX Exchange, Inc., Cboe Exchange,
Inc., Financial Industry Regulatory Authority, Inc., The Investors'
Exchange LLC, Long-Term Stock Exchange, Inc., Nasdaq BX, Inc.,
Nasdaq ISE, LLC, Nasdaq PHLX, Inc., The Nasdaq Stock Market LLC, New
York Stock Exchange LLC, NYSE American LLC, NYSE Arca, Inc., NYSE
Chicago, Inc., and NYSE National, Inc. (each a ``Participant'' and
collectively, the ``Participants''). Participants also are members
of the Plan's Operating Committees. Other parties include the
``Processor,'' who is charged with collecting, processing and
preparing for distribution or publication all Plan information. The
``Administrator'' is charged with administering the Plan to include
data feed approval, customer communications, contract management,
and related functions. ``Advisory Committee members'' are
individuals who represent particular types of financial services
firms or actors in the securities market, and who were selected by
Plan participants to be on the Advisory Committee A list of the
Processor, Administrator, and Advisory Committee members is
available at http://www.utpplan.com/governance.
    \5\ The Plan governs the collection, processing, and
dissemination on a consolidated basis of quotation information and
transaction reports in Eligible Securities for its Participants.
This consolidated information informs investors of the current
quotation and recent trade prices of Nasdaq securities. It enables
investors to ascertain from one data source the current prices in
all the markets trading Nasdaq securities. The Plan serves as the
required transaction reporting plan for its Participants, which is a
prerequisite for their trading Eligible Securities. See Securities
Exchange Act Release No. 55647 (April 19, 2007), 72 FR 20891 (April
26, 2007).
    \6\ See Transmittal Letter at 1.
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    The proposed Amendment has been filed by the Participants pursuant
to Rule 608(b)(2) under Regulation NMS.\7\ The Commission is publishing
this notice to solicit comments from interested persons on the proposed
Amendment.
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    \7\ 17 CFR 242.608(b)(2).
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    The Commission notes that, contemporaneously with the issuance of
this notice, it has issued a notice of proposed order (``Governance
Notice'') \8\ soliciting public comment on a proposed order that would
direct the national securities exchanges and the Financial Industry
Regulatory Authority, Inc. (collectively, ``SROs'') to act jointly in
developing and filing with the Commission a proposed new single
national market system plan, which will replace the existing national
market system plans that govern the public dissemination of real-time,
consolidated equity market data for national market system stocks
(``Equity Data Plans''). The Commission stated in the Governance Notice
its view that, among other concerns,

    \8\ See Securities Exchange Act Release No. 87906 (January 8,
2020).
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    [i]n the operation of the Equity Data Plans, Participants and
Participant representatives have been privy to confidential and
proprietary information of substantial commercial or competitive
value, including, among other things, information about core data
usage, the [securities information processors' or] SIPs' customer
lists, financial information, and subscriber audit results. However,
the terms of the Equity Data Plans do not address commercial use of
confidential or proprietary information by the Participants.\9\

    \9\ Id. at A-67 (footnotes omitted).
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    The Governance Notice solicits public comment on a proposed order
that would direct the SROs to include provisions in the New Data Plan
(as defined in the Governance Notice) addressing several issues arising
from the current governance structure of the Plan, and discusses the
Commission's view that the new data plan should include provisions
regarding the treatment of confidential information.
    In addition, contemporaneously with the publication of notice of
the Amendment set forth below, the Commission also is publishing a
separate proposed amendment from the Plan concerning a conflicts of
interest policy.

I. Text of the Amendment

    Set forth below is the entirety of the Amendment submission that
the Participants filed with the Commission, which includes a statement
of the purpose and summary of the Amendment, along with the information
required by Rules 608(a) and 601(a) under the Act.\10\
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    \10\ See 17 CFR 242.608(a)(4) and (a)(5).
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A. Purpose of the Amendment

1. Background
    Under the provisions of the Plan, the Advisory Committee has the
right to attend all meetings of the Operating Committee and receive any
information concerning Plan matters distributed to the Operating
Committee. The Advisory Committee also can attend meetings of most
subcommittees. The Operating Committee, however, may meet in Executive
Session without the Advisory Committee to discuss items that require
confidential treatment, as determined by majority vote of the Operating
Committee. Last year, the Participants adopted an Executive Session
Policy, which provides a specified list of topics that are appropriate
for Executive Session. Those topics include:
     Fees that require discussion of confidential financial
information;
     subscriber audit findings;
     discussions that require the disclosure of Material Non-
Public Information;
     financial reports containing confidential financial
information;
     the portion of a discussion or evaluation of administrator
and processor performance that includes confidential, non-public
information;
     contract negotiations, awards, and revocations that
contain non-public information;
     Advisory Committee member selection;
     litigation matters; and
     confidential, non-public discussions with the SEC.
    The Participants currently use Executive Sessions sparingly to
discuss confidential information. When used, the Executive Session
usually lasts less than thirty minutes and is used to discuss a limited
set of topics, often consisting of a single, discrete topic. Although
the Executive Session is sparingly used, the Participants are now
seeking additional ways to include the Advisory Committee in more
discussions and to share additional confidential information with the
Advisory Committee.
    Therefore, the Participants are proposing a confidentiality policy
to

allow the Operating Committee to share confidential information with
the Advisory Committee without concern that such information would be
more broadly disseminated. By sharing information that would in the
ordinary course be considered appropriate for confidential treatment,
the Participants believe that the Advisory Committee will be able to
provide more informed advice and recommendations with respect to the
operation and governance of the Plan. Further, the confidentiality
policy is designed to protect against any potential misuse of
confidential information by: (1) Restricting the use and dissemination
of customer-related information; (2) requiring the Administrator and
Processor to maintain confidential information policies that will be
reviewed by the Operating Committee at least every two years; (3)
permitting disclosure of confidential information by a representative
of a Participant to other employees or agents of the Participant or its
affiliates only as needed to perform that representative's function on
behalf of the Participant; and (4) setting clear procedures regarding
the treatment of various forms of confidential information.
    The Participants discussed this proposal extensively with the
Advisory Committee and this proposal reflects input and comments from
the members of the Advisory Committee.
2. Proposed Confidentiality Policy
    In an effort to expand the information that the Operating Committee
may provide to the Advisory Committee, and also to provide guidelines
about what information can and cannot be shared outside the meetings of
the Operating Committee, the Participants are proposing to adopt a
confidentiality policy.
    The proposed confidentiality policy would apply to all
representatives of the Participants, Pending Participants, the UTP
Administrator and Processor, and the Advisory Committee. Additionally,
it would apply to agents of the Operating Committee, including, but not
limited to, attorneys, advisors, accountants, contractors or
subcontractors (``Agents''), as well as any third parties invited to
attend meetings of the Operating Committee or Plan subcommittees. These
persons are collectively defined in the confidentiality policy as
``Covered Persons.'' \11\
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    \11\ Covered Persons would not include staff of the Commission.
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    The proposed confidentiality policy creates three categories of
confidential information: (1) Restricted Information; (2) Highly
Confidential Information; and (3) Confidential Information. Restricted
Information is defined as (i) highly sensitive customer-specific
financial information, (ii) customer-specific audit information, (iii)
other customer financial information, and (iv) Personal Identifiable
Information. Highly Confidential Information is defined as (i) any data
or information shared in an Executive Session or that would otherwise
qualify for confidential treatment pursuant to the Plan's Executive
Session Policy; \12\ and (ii) any other highly sensitive Participant-
specific, customer-specific, individual-specific, or otherwise
sensitive information relating to the Operating Committee,
Participants, or customers that is not otherwise Restricted
Information. Highly Confidential Information includes: A Participant's
contract negotiations with the Processor or Administrator; personnel
matters; information concerning the intellectual property of
Participants or customers; and any document subject to the Attorney-
Client Privilege or Work Product Doctrine. Finally, Confidential
Information is defined as (i) any non-public data or information
designated as Confidential by a majority vote of the Operating
Committee; (ii) any document generated by a Participant or Advisor and
designated by that Participant or Advisor as Confidential; (iii) the
minutes of the Operating Committee or any subcommittee thereof unless
approved by the Operating Committee for release to the public; and (iv)
the individual views and statements of Covered Persons and SEC staff
disclosed during a meeting of the Operating Committee or any
subcommittees thereunder.
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    \12\ Although Highly Confidential Information includes data or
information shared in an Executive Session, the Participants plan on
including more information in General Session rather than Executive
Session. The proposed confidentiality policy allows the Participants
to share more sensitive information with the Advisory Committee
without concerns that such information would be more broadly
disseminated. Therefore, the Participants intend to share additional
information, previously designated for Executive Session, with the
Advisory Committee, including confidential financial information.
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    The confidentiality policy outlines the procedures with respect to
identifying documents as Restricted, Highly Confidential, or
Confidential as well as the procedures regarding how to treat documents
and information in each category. With respect to general procedures,
the confidentiality policy places the obligation on the Administrator
and the Processor to be the custodian of all documents and to maintain
the classification of such documents. The Administrator will ensure
that all documents are properly labeled with the appropriate category.
The Administrator may, under delegated authority, designate documents
as Restricted, Highly Confidential, or Confidential, which will be
determinative unless altered by a majority vote of the Operating
Committee. Finally, all contracts between the Operating Committee and
its Agents will require the Operating Committee information to be
treated as Confidential Information that may not be disclosed to third
parties, except as necessary to effect the terms of the contract or as
required by law.
3. Procedures Governing Restricted Information
    With respect to Restricted Information, the proposed
confidentiality policy provides that such information will be kept in
confidence by the Administrator and Processor and will not be disclosed
to the Operating Committee or any subcommittee thereof, or during
Executive Session, or the Advisory Committee, except in the following
circumstances:
    1. If an Administrator determines that it is appropriate to share a
customer's financial information with the Operating Committee or a
subcommittee thereof, the Administrator will first anonymize the
information by redacting the customer's name and any other information
that may lead to the identification of the customer.
    2. The Administrator may disclose the identity of a customer that
is the subject of the Restricted Information in Executive Session only
if the Administrator determines in good faith that it is necessary to
disclose the customer's identity in order to obtain input or feedback
from the Operating Committee or a subcommittee thereof about a matter
of importance to the Plan. In such an event, the Administrator will
change the designation of the information at issue from ``Restricted
Information'' to ``Highly Confidential Information.''
    3. The Administrator may share Restricted Information related to
any willful, reckless, or grossly negligent conduct by a customer
discovered by the Administrator with the UTP Administrator or with the
SEC, as appropriate, upon majority vote of the Operating Committee in
Executive Session, provided that, in any report by the Administrator
during Executive Session related to such disclosure, the Administrator
anonymizes the information related to the wrongdoing

by removing the names of the party or parties involved, as well as any
other information that may lead to the identification of such party or
parties.
    The Participants believe that the procedures governing Restricted
Information will ensure the protection of customer identities and
customer-related information, and such information will be disclosed
only when necessary to conduct Plan-related business.
4. Procedures Governing Highly Confidential Information
    With respect to Highly Confidential Information, the proposed
confidentiality policy provides that such information may be disclosed
only in Executive Session of the Operating Committee or to the Legal
Subcommittee. Highly Confidential Information may also be disclosed to
SEC staff, unless it is protected by the Attorney-Client Privilege or
the Work Product Doctrine. Any disclosure of Highly Confidential
Information to SEC staff will be accompanied by a FOIA Confidential
Treatment Request. The confidentiality policy does not permit any other
disclosure of Highly Confidential Information.
    In addition, a Covered Person that is a representative of a
Participant may disclose Highly Confidential Information to other
employees or agents of the Participant or its affiliates only as needed
for such Covered Person to perform his or her function on behalf of the
Participant, as reasonably determined by the Covered Person. A copy of
the confidentiality policy will be made available to recipients of such
information who are employees or agents of a Participant or its
affiliates that are not Covered Persons, who will be required to abide
by the confidentiality policy.
    Further, because of the heightened concerns regarding the
disclosure of Highly Confidential Information, in the event a Covered
Person is determined by a majority vote of the Operating Committee to
have disclosed Highly Confidential Information, the Operating Committee
will determine the appropriate remedy for the breach based on the facts
and circumstances of the event. For the representatives of a
Participant, appropriate remedies include a letter of complaint
submitted to the SEC, which may be made public by the Operating
Committee. For a member of the Advisory Committee, appropriate remedies
include removal of that member from the Advisory Committee.
5. Procedures Governing Confidential Information
    Under the proposed confidentiality policy, Confidential Information
may be disclosed to the Operating Committee, any subcommittee thereof,
and the Advisory Committee. A Covered Person may not disclose
Confidential Information to any individual that is not either a Covered
Person or a member of the SEC staff, except with authorization of the
Operating Committee, or as may be otherwise required by law. The
Operating Committee or a subcommittee thereof may authorize the
disclosure of Confidential Information by an affirmative vote of the
number of members that represent a majority of the total number of
members of the Operating Committee or subcommittee. However, with
respect to Confidential Information that is generated by a Participant
or member of the Advisory Committee, the Operating Committee may
authorize its disclosure only with the consent of such Participant or
member of the Advisory Committee.
    In order to elicit industry feedback, members of the Advisory
Committee may be authorized by the Operating Committee to disclose
particular Confidential Information to enable them to consult with
third-party industry representatives or technical experts, provided
that the member of the Advisory Committee takes any steps requested by
the Operating Committee to prevent further dissemination of that
Confidential Information, including providing the individuals consulted
with a copy of the confidentiality policy and requesting that person to
maintain the confidentiality of such information in a manner consistent
with the confidentiality policy.
    A Covered Person that is a representative of a Participant may
disclose Confidential Information to other employees or agents of the
Participant or its affiliates only as needed for such Covered Person to
perform his or her function on behalf of the Participant, as reasonably
determined by the Covered Person. A copy of the confidentiality policy
will be made available to recipients of such information who are
employees or agents of a Participant or its affiliates that are not
Covered Persons, who will be required to abide by the confidentiality
policy.
    A Covered Person may disclose his or her own individual views and
statements that may otherwise be considered Confidential Information
without obtaining authorization of the Operating Committee provided
that the Covered Person is not disclosing the views or statements of
any other Covered Person or Participant that are considered
Confidential Information.
    Finally, a Covered Person that discloses Confidential Information
without the authorization of the Operating Committee will report such
disclosure to the Chair of the Operating Committee. Such unauthorized
disclosure of Confidential Information will be recorded in the minutes
of the meeting of the Operating Committee and will contain: (a) The
name(s) of the person(s) who disclosed such Confidential Information,
and (b) a description of the Confidential Information disclosed. The
name(s) of the person(s) who disclosed such Confidential Information
will also be recorded in any publicly available summaries of Operating
Committee minutes.

B. Governing or Constituent Documents

    Not applicable.

C. Implementation of Amendment

    Each of the Participants has approved the amendment in accordance
with Section IV.C of the UTP Plan. The Participants also received and
incorporated feedback from the Advisory Committee in preparing the
confidentiality policy.

D. Development and Implementation Phases

    Not applicable.

E. Analysis of Impact on Competition

    The Participants believe that the proposed amendment does not
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act.
    The Participants believe that the proposed confidentiality policy
will provide enhanced disclosure to the Advisory Committee regarding
matters that the Participants consider confidential information.
Currently, the Plan allows information to be discussed in Executive
Session when the Operating Committee determines that an item of Plan
business requires confidential treatment. Despite the confidential
nature of the information, the Participants believe that inclusion of
the Advisory Committee in certain discussions that involve confidential
information would be beneficial for the operation and governance of the
Plan.
    The confidentiality policy allows such information to be more
freely shared with the Advisory Committee without concerns that the
confidential information will be disseminated more broadly.
Additionally, the confidentiality policy provides guidance

to the representatives of Participants on how to treat confidential
information that they obtained through the course of participating on
the Operating Committee, thereby reducing confusion among the
representatives of the Participants. Finally, by requiring Agents of
the Operating Committee to adhere to the confidentiality policy, the
confidentiality policy will ensure that such Agents will be subject to
the same requirements as the Operating Committee when handling
confidential information.
    Additionally, the proposed confidentiality policy will protect
customer-specific information in the possession of the Administrator
and Processor. The procedures surrounding the use of Restricted
Information will help to ensure that the dissemination of Restricted
Information is limited to instances when necessary for the operation of
the Plan. Further, the confidentiality policy requires the
Administrator and Processor to establish written confidential
information policies that provide for the protection of information
under their control. Therefore, the confidentiality policy is designed
to protect confidential information obtained or generated by the
Administrator and Processor in connection with the operation of the
Plan.
    Finally, as noted above, the proposal was vetted With the Advisory
Committee to include its input into a policy that would enhance the
amount of information available to the Advisory Committee.

F. Written Understanding or Agreement Relating to Interpretation of, or
Participating in Plan

    Not applicable.

G. Approval by Sponsors in Accordance With Plan

    Section IV.C.1 of the UTP Plan require the Participants to
unanimously approve the amendment proposed herein. They have so
approved it.

H. Description of Operation of Facility Contemplated by the Proposed
Amendment

    Not applicable.

I. Terms and Conditions of Access

    Not applicable.

J. Method of Determination and Imposition and Amount of, Fees and
Charges

    Not applicable.

K. Method and Frequency of Processor Evaluation

    Not applicable.

L. Dispute Resolution

    Not applicable.

II. Regulation NMS Rule 601(a)

A. Equity Securities for Which Transaction Reports Shall be Required by
the Plan

    Not applicable.

B. Reporting Requirements

    Not applicable.

C. Manner of Collecting, Processing, Sequencing, Making Available and
Disseminating Last Sale Information

    Not applicable.

D. Manner of Consolidation

    Not applicable.

E. Standards and Methods Ensuring Promptness, Accuracy and Completeness
of Transaction Reports

    Not applicable.

F. Rules and Procedures Addressed to Fraudulent or Manipulative
Dissemination

    Not applicable.

G. Terms of Access to Transaction Reports

    Not applicable.

H. Identification of Marketplace of Execution

    Not applicable.

III. Solicitation of Comments

    The Commission seeks comments on the Amendment. Interested persons
are invited to submit written data, views, and comments concerning the
foregoing, including whether the Amendment is consistent with the Act
and the rules thereunder. Among other things, the Commission asks
commenters to consider whether the Amendment to the current Plan
addresses the concerns outlined in the Governance Notice or whether
they should be further enhanced regarding the identification and
protection of confidential information. Accordingly, the Commission
requests comments on matters including, but not limited to, the
following:
    1. Do commenters believe that Participants involved in the
operation or governance of each Plan have, by consequence of their
position, access to information of substantial commercial and
competitive value? If so, do commenters believe that certain of that
information, including customer-specific financial information,
customer-specific audit information, personally identifiable
information, and information concerning the intellectual property of
Participants or customers, is highly sensitive to such a degree that
its possession and use should be more tightly controlled? Please
explain. For example, should the Amendment require logs and written
attestations when a Covered Person shares Highly Confidential
Information with other employees or agents of the Participant or its
affiliates? Do commenters believe the Amendment should specifically
address commercial use of information that is of substantial
competitive value?
    2. Do commenters believe that Participants' representatives should
be subject to restrictions and/or information barriers as part of the
confidentiality policy to address their direct or indirect involvement
in the development or sale of proprietary data products to SIP
customers? For example, do commenters believe that Participants' access
to a list of the Processor's customers as well as information on those
customers' data usage and fees paid to the Plan has competitive
implications? Do commenters believe that the Plan should require
recusal in certain circumstances (e.g., during Executive Sessions or
Operating Committee meetings) because the potential for misuse of
competitively sensitive confidential information is too great? If so,
what should those circumstances be? Do commenters believe that any
Participant or Advisory Committee member that is directly involved in
the management, sale, or development of similar proprietary market data
products that may be sold to customers of the SIPs should have access
to any customer information from the SIPs? Do commenters believe that
Operating Committee members, as well as the Administrator, Processor,
and auditor should be prohibited, unless otherwise required by law,
from sharing confidential information with individuals that are not
involved with the operation of the Plan and individuals employed by or
affiliated with the same entity if such individuals are involved in the
management, sale, or development of proprietary data products that are
offered separately to a substantially similar customer base, i.e.,
customers or potential customer of the SIPs? Would these concerns also
be present for the sale of related data products that are supplemental
to SIP data?
    3. Do commenters believe that the Plan should require all
Participants and other Covered Persons to establish, maintain, and
enforce policies and procedures to safeguard confidential and
proprietary information received via their participation in the Plan
and to

prevent its misuse by such Participants or entities controlling,
controlled by, or under common control with such Participants? If so,
do commenters believe the proposed Amendment sufficiently achieves that
goal?
    4. Do commenters believe the proposed guidelines and procedures for
identifying and categorizing types of confidential information,
including for providing increasing degrees of protection for more
sensitive types of confidential information, provide sufficient detail
and a sufficiently comprehensive process and procedures to identify,
classify, and subsequently protect confidential information? Or do
commenters believe that further efforts are necessary to identify,
categorize, and protect confidential information and/or information of
substantial competitive or commercial value? Do commenters believe that
a need may arise for information or data that are not initially
categorized as confidential to be categorized as such at a later point
in time and, if so, what should the process be for doing so? For
example, should the Operating Committee be able to classify or de-
classify material as appropriate based on a majority vote?
    5. Do commenters believe that the Administrator and Processor
should be solely responsible for classifying material according to the
proposed standards? Or do commenters believe the decisions of the
Administrator and Processor should be subject to review, for example
upon the request of a member of the Operating Committee? Do commenters
believe that potential conflicts of interest should preclude the
Administrator and Processor from solely and independently making
classification determinations in those circumstances when entities with
which they are directly or indirectly affiliated separately offer
proprietary data products to a substantially similar customer base,
i.e., customers or potential customers of the SIPs?
    6. Do commenters believe that certain information or data
generated, accessed, transmitted to, or discussed by the Operating
Committee, such as information regarding contract negotiations with a
potential new Processor, Administrator, auditor, or other third party
service provider, should be designated as confidential and, if so, what
level of confidentiality should such information be afforded?
    7. Do commenters believe that information shared in Executive
Sessions should be classified as Highly Confidential simply by virtue
of it having been shared in an Executive Session, or should such
information be classified based solely on its content and competitive
sensitivity?
    8. Do commenters believe that information that is not classified at
some level of confidentiality should be considered public and may be
shared freely outside of the Operating Committee? What specific
information do commenters believe should be considered public and
shared outside of the Operating Committee?
    9. Do commenters believe that the proposed guidelines and
procedures setting forth the circumstances in which disclosure of
confidential information may be authorized are sufficiently clear and
comprehensive? Do commenters believe that the proposed provisions
allowing Participants to disclose confidential and highly confidential
information to other employees or agents of the Participant or its
affiliates as needed as they reasonably determine is appropriate? Or do
commenters believe that, if a Participant is either employed by or
affiliated with an entity that offers proprietary data products that
are offered for sale to a substantially similar customer base (i.e.,
customer or potential customers of the SIPs), that Participant should
be required to develop policies and procedures that govern the sharing
of confidential information? Do commenters believe such policies and
procedures should be reviewed by the Operating Committee and Advisors
and made publicly available via the Plan's website? Do commenters
believe that the potential conflicts of interest involved and the
difficulty of mitigating the potential harm and potential burdens on
competition are so great that Participants should be explicitly
prohibited from disclosing restricted and confidential information at
all or only if authorized to do so on a case-by-case basis from the
Operating Committee, unless such disclosure is otherwise required by
law? If disclosure is required by law, should the Covered Person be
required to first notify the Operating Committee (e.g., to provide the
Operating Committee with an opportunity to redact information if
permitted by applicable law or to dispute the requirement to provide in
its entirety)?
    10. Do commenters believe that certain confidential information may
become less sensitive if it is anonymized and aggregated? If so, do
commenters believe that certain types of restricted or highly
confidential information could be anonymized and aggregated to the
point where it could be classified as public? What methodology for
anonymizing confidential information would commenters suggest, and
should the methodology be standardized such that the Administrator,
Processor, and auditor all follow a consistent practice for anonymizing
such information? Do commenters believe that certain information is so
sensitive, whether anonymized or not, that it should never be shared
outside of the Operating Committee or outside of the Administrator?
    11. Do commenters believe that the scope of the proposed Amendment
is sufficiently comprehensive to cover all parties that might have
access to confidential information, or should the scope be broadened to
apply to additional classes of persons? For example, should outsourced
service providers (including, but not limited to, firms and persons
that provide audit services, accounting services, or legal services to
the Plan, the Administrator, or the Processor) be subject to additional
restrictions, particularly if they are directly or indirectly
affiliated with a Participant, the Administrator, the Processor, or any
entity that offers separately proprietary data products to a
substantially similar customer base, i.e., customers or potential
customers of the SIPs? If so, should the Plan explicitly preclude
itself from engaging with an Administrator, Processor, auditor, or any
agents or third parties thereof, unless the entity establishes,
maintains, and enforces policies and procedures to safeguard
confidential and proprietary information and to prevent its direct or
indirect misuse? If so, should the Operating Committee review those
policies and procedures and/or should they be made public (i.e.,
provided on the Plan's website)? For example, if the Administrator
oversees a Plan's audit function (directly or through an agent or third
party) but also is affiliated with an entity that sells proprietary
data products to SIP customers, do commenters believe that potential
conflicts of interest should preclude the Administrator from
independently determining its own confidential information policies as
they apply to the audit function? Or, should such policies be subject
to review and approval by the Operating Committee, and be posted
publicly, to help ensure their adequacy and completeness?
    12. Do commenters believe that Advisory Committee members need
access to sensitive information of substantial commercial and
competitive value in order to perform their duties? Do commenters
believe that the Advisory Committee members need access to underlying
information relied on by the Participants when making

decisions on funding of and improvements for the SIPs?
    13. Do commenters believe the proposed remedy in the event that a
Covered Person discloses ``Highly Confidential Information'' in a
manner inconsistent with the proposed policy is sufficient, or should
any other consequences of such disclosure be provided?
    14. Similarly, do commenters believe the Amendment would
sufficiently deter unauthorized disclosure of ``Confidential
Information'' by a Covered Person without authorization by the
Operating Committee? Do commenters believe appropriate remedies for
Participants and Advisors should differ, or should potential remedies
for Participants that disclose confidential information also include
the possibility of removal of that Participant from the Operating
Committee?
    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 S7-24-89 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 S7-24-89. 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 website (http://www.sec.gov/rules/sro.shtml). Copies of
the submission, all written statements with respect to the proposed
Amendment that are filed with the Commission, and all written
communications relating to the proposed Amendment 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 3:00p.m. Copies of
the filing also will be available for website viewing and printing at
the principal office of the Plan. All comments received will be posted
without change. Persons submitting comments are cautioned that we do
not redact or edit personal identifying information from comment
submissions. You should submit only information that you wish to make
available publicly. All submissions should refer to File Number S7-24-
89 and should be submitted on or before February 4, 2020.

    By the Commission.
Vanessa A. Countryman,
Secretary.
[FR Doc. 2020-00358 Filed 1-13-20; 8:45 am]
BILLING CODE 8011-01-P


--------------------------------------------------------------------------------
MEMORANDUM FOR THE DOCKET
--------------------------------------------------------------------------------
Subject:	Input data for the overall risk assessment and the at-risk analysis completed using BenMAP-CE as part of the PM NAAQS Reconsideration
--------------------------------------------------------------------------------
Date: 		October 12, 2021
EPA has placed into docket number EPA-HQ-OAR-2015-0072, files used in generating the mortality estimates for the overall risk assessment and the at-risk analysis completed using BenMAP-CE as part of the PM NAAQS Reconsideration. The assessment was completed using BenMAP-CE version <IP_ADDRESS>. Health incidence estimates can be reproduced either by performing individual parameterized runs for a given air quality scenario and set of urban study areas using the BenMAP graphical user interface (GUI) or performing batch runs using scripts.
BenMAP runs were batch processed using command line and a written script. The full set of estimates can be reproduced using the automation script files available in the docket materials, which can be run from the command prompt using the input air quality surface files. See Appendix L of the BenMAP manual for additional details.
The standard BenMAP folders are included in the docket materials, however in some cases there are two sub-folders distinguishing files for the "Overall Risk Assessment" and "At-Risk Analysis." Script file can be reviewed and modified in a text editor such as Notepad++, which includes comments preceded by "#". Prior to running the script from the command line, a number of subdirectory pointers within the automation code must be set to where the user has placed the input files and results directories for outputs. Imbedded notes within the automation code highlight the pointers which must be updated, which appear near the beginning of the script file. Once pointers have been updated and the required input files have been placed in the appropriate subdirectories (see below), then the script run is initiated with the below commands from the command prompt:
 Direct to the location where the BenMAP program is located (e.g., "cd\program files (x86)\BenMAP-CE") and hit Enter
 Direct to the script file (e.g., "C:\ PM_NAAQS_RA.ctlx")

In order to run the automated script, make sure that the following subdirectories have been created, include the necessary input files, and the script has been edited to their location:

 "Inputs" Containing the air quality grid .csv files
 "AQG" Will be the location of output .aqg air quality surface files
 "CFG" Containing the BenMAP configuration file used as the basis for generating risk estimates, PM_NAAQS_HHRA.cfgx
 "APV" Contains BenMAP aggregation and pooling file which allows reports containing the risk estimates to be generated, PM_NAAQS_HHRA.apvx
 "Reports" Will be the location of output .csv files
 "Results" Will be the location of output .cfgrx and .apvrx files


[Federal Register: August 18, 2008 (Volume 73, Number 160)]
[Notices]
[Page 48237]
[DOCID:fr18au08-82]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[FEMA-1780-DR]

Texas; Amendment No. 2 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 Texas (FEMA-1780-DR), dated July 24, 2008, and related
determinations.

DATES: Effective Date: August 1, 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: Notice is hereby given that the incident
period for this disaster is closed effective August 1, 2008.

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

R. David Paulison,
Administrator, Federal Emergency Management Agency.
[FR Doc. E8-19021 Filed 8-15-08; 8:45 am]

BILLING CODE 9110-10-P


[Federal Register Volume 88, Number 210 (Wednesday, November 1, 2023)]
[Notices]
[Pages 75003-75004]
[FR Doc No: 2023-24124]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-E-3178]

Determination of Regulatory Review Period for Purposes of Patent
Extension; Omegaven

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or the Agency) has
determined the regulatory review period for Omegaven and is publishing
this notice of that determination as required by law. FDA has made the
determination because of the submission of an application to the
Director of the U.S. Patent and Trademark Office (USPTO), Department of
Commerce, for the extension of a patent which claims that human drug
product.

DATES: Anyone with knowledge that any of the dates as published (see
SUPPLEMENTARY INFORMATION) are incorrect may submit either electronic
or written comments and ask for a redetermination by January 2, 2024.
Furthermore, any interested person may petition FDA for a determination
regarding whether the applicant for extension acted with due diligence
during the regulatory review period by April 29, 2024. See
``Petitions'' in the SUPPLEMENTARY INFORMATION section for more
information.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before January 2, 2024. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of January 2, 2024.Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are received on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://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 https://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): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, 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-2019-E-3178 for ``Determination of Regulatory Review Period for
Purposes of Patent Extension; OMEGAVEN.'' Received comments, those
filed in a timely manner (see ADDRESSES), will be placed in the docket
and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
     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 https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. 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 Sec.  10.20 (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: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://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 Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6250, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984
(Pub. L. 98-417) and the Generic Animal Drug and Patent Term
Restoration Act (Pub. L. 100-670) generally provide that a patent may
be extended for a period of up to 5 years so long as the patented item
(human

drug product, animal drug product, medical device, food additive, or
color additive) was subject to regulatory review by FDA before the item
was marketed. Under these acts, a product's regulatory review period
forms the basis for determining the amount of extension an applicant
may receive.
    A regulatory review period consists of two periods of time: a
testing phase and an approval phase. For human drug products, the
testing phase begins when the exemption to permit the clinical
investigations of the drug becomes effective and runs until the
approval phase begins. The approval phase starts with the initial
submission of an application to market the human drug product and
continues until FDA grants permission to market the drug product.
Although only a portion of a regulatory review period may count toward
the actual amount of extension that the Director of USPTO may award
(for example, half the testing phase must be subtracted as well as any
time that may have occurred before the patent was issued), FDA's
determination of the length of a regulatory review period for a human
drug product will include all of the testing phase and approval phase
as specified in 35 U.S.C. 156(g)(1)(B).
    FDA has approved for marketing the human drug product, Omegaven
(fish oil triglycerides) indicated as a source of calories and fatty
acids in pediatric patients with parenteral nutrition-associated
cholestasis. Subsequent to this approval, the USPTO received a patent
term restoration application for Omegaven (U.S. Patent No. 9,566,260)
from Children's Medical Center Corporation and the USPTO requested
FDA's assistance in determining the patent's eligibility for patent
term restoration. In a letter dated November 29, 2019, FDA advised the
USPTO that this human drug product had undergone a regulatory review
period and that the approval of Omegaven represented the first
permitted commercial marketing or use of the product. Thereafter, the
USPTO requested that FDA determine the product's regulatory review
period.

II. Determination of Regulatory Review Period

    FDA has determined that the applicable regulatory review period for
Omegaven is 4,246 days. Of this time, 4,007 days occurred during the
testing phase of the regulatory review period, while 239 days occurred
during the approval phase. These periods of time were derived from the
following dates:
    1. The date an exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(i)) became effective:
December 13, 2006. FDA has verified the applicant's claim that the date
the investigational new drug application became effective was on
December 13, 2006.
    2. The date the application was initially submitted with respect to
the human drug product under section 505 of the FD&C Act: December 1,
2017. FDA has verified the applicant's claim that the new drug
application (NDA) for Omegaven (NDA 210589) was initially submitted on
December 1, 2017.
    3. The date the application was approved: July 27, 2018. FDA has
verified the applicant's claim that NDA 210589 was approved on July 27,
2018.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the USPTO
applies several statutory limitations in its calculations of the actual
period for patent extension. In its application for patent extension,
this applicant seeks 383 days of patent term extension.

III. Petitions

    Anyone with knowledge that any of the dates as published are
incorrect may submit either electronic or written comments and, under
21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as
specified in Sec.  60.30 (21 CFR 60.30), any interested person may
petition FDA for a determination regarding whether the applicant for
extension acted with due diligence during the regulatory review period.
To meet its burden, the petition must comply with all the requirements
of Sec.  60.30, including but not limited to: must be timely (see
DATES), must be filed in accordance with Sec.  10.20, must contain
sufficient facts to merit an FDA investigation, and must certify that a
true and complete copy of the petition has been served upon the patent
applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42,
1984.) Petitions should be in the format specified in 21 CFR 10.30.
    Submit petitions electronically to https://www.regulations.gov at
Docket No. FDA-2013-S-0610. Submit written petitions (two copies are
required) to the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Dated: October 27, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-24124 Filed 10-31-23; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 79, Number 144 (Monday, July 28, 2014)]
[Rules and Regulations]
[Pages 43604-43607]
[FR Doc No: 2014-17297]

=======================================================================
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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2014-0007; Directorate Identifier 2012-NM-038-AD;
Amendment 39-17889; AD 2014-13-13]
RIN 2120-AA64

Airworthiness Directives; Fokker Services B.V. Airplanes

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Final rule.

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

SUMMARY: We are adopting a new airworthiness directive (AD) for all
Fokker Services B.V. Model F.28 Mark 0070 and 0100 airplanes. This AD
was prompted by reports that the bracket of the rod in the carbon fiber
reinforced plastic (CFRP) main landing gear (MLG) outboard door had
detached. In addition, we received reports of broken recessed heads on
titanium attachment bolts of the operating rod brackets on the modified
CFRP MLG outboard doors. This AD requires a detailed inspection of the
CFRP MLG outboard door for play or cracks in the recessed countersunk
heads of the operating rod bracket attachment bolts; replacement of the
bolt if necessary; and, for certain airplanes, modification of the CFRP
MLG outboard doors and attachment to the MLG. We are issuing this AD to
detect and correct the affected MLG from moving to the down and locked
position, which could result in MLG collapse during landing or roll-
out, and consequent damage to the airplane and injury to passengers.

DATES: This AD becomes effective September 2, 2014.
    The Director of the Federal Register approved the incorporation by
reference of certain publications listed in this AD as of September 2,
2014.

ADDRESSES: You may examine the AD docket on the Internet at http://www.regulations.gov/#!docketDetail;D=FAA-2014-0007; or in person at the
Docket Management Facility, U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC.
    For service information identified in this AD, contact Fokker
Services B.V., Technical Services Dept., P.O. Box 1357, 2130 EL
Hoofddorp, the Netherlands; telephone +31 (0)88-6280-350; fax +31
(0)88-6280-111; email<EMAIL_ADDRESS>Internet http://www.myfokkerfleet.com. You may view this referenced service information
at the FAA, Transport Airplane Directorate, 1601 Lind Avenue SW.,
Renton, WA. For information on the availability of this material at the
FAA, call<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Tom Rodriguez, Aerospace Engineer,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
1601 Lind Avenue SW., Renton, WA 98057-3356; telephone<PHONE_NUMBER>;
fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 by adding an AD that would apply to all Fokker Services B.V.
Model F.28 Mark 0070 and 0100 airplanes. The NPRM published in the
Federal Register on February 3, 2014 (79 FR 6109).
    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Community, has issued
Airworthiness Directive 2012-0023, dated February 6, 2012 (referred to
after this as the Mandatory Continuing Airworthiness Information, or
``the MCAI''), to correct an unsafe condition for all Fokker Services
B.V. Model F.28 Mark 0070 and 0100 airplanes. The MCAI states:

    In 2005, several occurrences were reported where the bracket of
the rod in the Carbon Fibre Reinforced Plastic (CFRP) MLG outboard
door had detached, preventing the MLG to lock properly when selected
down. Prompted by these reports, CAA-NL [Civil

Aviation Authority-Netherlands] issued AD NL-2006-001 [http://ad.easa.europa.eu/blob/easa_ad_2006_0002_NL2006001.pdf/AD_NL-2006-001_1] (EASA approval 2006-0002) to require the inspection and
modification of the attachment of the operating rod bracket as
detailed in Fokker Service Bulletin (SB) SBF100-52-080.
    After that [EASA] AD was issued, several operators reported
broken recessed heads of titanium attachment bolts of the operating
rod bracket on modified (i.e. post-SBF100-52-080) CFRP MLG outboard
doors. In such a situation, the remaining bolt shafts can get pulled
through the external repair patch and the carbon fibre door outer
skin, causing the operating rod, with the detached bracket, to get
stuck between the MLG main fitting and wing lower skin. The primary
factor to the cause of breaking bolt heads has been determined to be
incorrect adjustment of the MLG outboard door.
    This condition, if not detected and corrected, would prevent the
affected MLG from moving to the down and locked position, possibly
resulting in MLG collapse during landing or roll-out and consequent
damage to the aeroplane and/or injury to the occupants.
    To address this potential unsafe condition, Fokker Services has
published SBF100-52-090, providing modification instructions to
install an improved attachment of the MLG outboard door operating
rod.
    For the reasons described above, this new [EASA] AD requires a
one-time detailed inspection for play or cracks in the recessed bolt
heads and, depending on findings, applicable corrective actions,
modification of the operating rod bracket attachment to the CFRP MLG
outboard door, and introduction of a weaker (aluminum) bolt in the
attachment of the MLG outboard door operating rod.

    You may examine the MCAI in the AD docket on the Internet at http://www.regulations.gov/#!docketDetail;D=FAA-2014-0007-0002.

Comments

    We gave the public the opportunity to participate in developing
this AD. We received no comments on the NPRM (79 FR 6109, February 3,
2014) or on the determination of the cost to the public.

``Contacting the Manufacturer'' Paragraph in This AD

    Since late 2006, we have included a standard paragraph titled
``Airworthy Product'' in all MCAI ADs in which the FAA develops an AD
based on a foreign authority's AD.
    The MCAI or referenced service information in an FAA AD often
directs the owner/operator to contact the manufacturer for corrective
actions, such as a repair. Briefly, the Airworthy Product paragraph
allowed owners/operators to use corrective actions provided by the
manufacturer if those actions were FAA-approved. In addition, the
paragraph stated that any actions approved by the State of Design
Authority (or its delegated agent) are considered to be FAA-approved.
    In the NPRM (79 FR 6109, February 3, 2014), we proposed to prevent
the use of repairs that were not specifically developed to correct the
unsafe condition, by requiring that the repair approval provided by the
State of Design Authority or its delegated agent specifically refer to
this FAA AD. This change was intended to clarify the method of
compliance and to provide operators with better visibility of repairs
that are specifically developed and approved to correct the unsafe
condition. In addition, we proposed to change the phrase ``its
delegated agent'' to include a design approval holder (DAH) with State
of Design Authority design organization approval (DOA), as applicable,
to refer to a DAH authorized to approve required repairs for the
proposed AD.
    No comments were provided to the NPRM (79 FR 6109, February 3,
2014) about these proposed changes. However, a comment was provided for
another NPRM, Directorate Identifier 2012-NM-101-AD (78 FR 78285,
December 26, 2013). The commenter stated the following: ``The proposed
wording, being specific to repairs, eliminates the interpretation that
Airbus messages are acceptable for approving minor deviations
(corrective actions) needed during accomplishment of an AD mandated
Airbus service bulletin.''
    This comment has made the FAA aware that some operators have
misunderstood or misinterpreted the Airworthy Product paragraph to
allow the owner/operator to use messages provided by the manufacturer
as approval of deviations during the accomplishment of an AD-mandated
action. The Airworthy Product paragraph does not approve messages or
other information provided by the manufacturer for deviations to the
requirements of the AD-mandated actions. The Airworthy Product
paragraph only addresses the requirement to contact the manufacturer
for corrective actions for the identified unsafe condition and does not
cover deviations from other AD requirements. However, deviations to AD-
required actions are addressed in 14 CFR 39.17, and anyone may request
the approval for an alternative method of compliance to the AD-required
actions using the procedures found in 14 CFR 39.19.
    To address this misunderstanding and misinterpretation of the
Airworthy Product paragraph, we have changed that paragraph and
retitled it ``Contacting the Manufacturer.'' This paragraph now
clarifies that for any requirement in this AD to obtain corrective
actions from a manufacturer, the action must be accomplished using a
method approved by the FAA, the European Aviation Safety Agency (EASA),
or Airbus's EASA DOA. Where necessary throughout this AD, we also
replaced any reference to approvals of corrective actions with a
reference to the Contacting the Manufacturer paragraph.
    The Contacting the Manufacturer paragraph also clarifies that, if
approved by the DOA, the approval must include the DOA-authorized
signature. The DOA signature indicates that the data and information
contained in the document are EASA-approved, which is also FAA-
approved. Messages and other information provided by the manufacturer
that do not contain the DOA-authorized signature approval are not EASA-
approved, unless EASA directly approves the manufacturer's message or
other information.
    This clarification does not remove flexibility previously afforded
by the Airworthy Product paragraph. Consistent with long-standing FAA
policy, such flexibility was never intended for required actions. This
is also consistent with the recommendation of the Airworthiness
Directive Implementation Aviation Rulemaking Committee to increase
flexibility in complying with ADs by identifying those actions in
manufacturers' service instructions that are ``Required for
Compliance'' with ADs. We continue to work with manufacturers to
implement this recommendation. But once we determine that an action is
required, any deviation from the requirement must be approved as an
alternative method of compliance.
    Other commenters to the NPRM discussed previously, Directorate
Identifier 2012-NM-101-AD (78 FR 78285, December 26, 2013), pointed out
that in many cases the foreign manufacturer's service bulletin and the
foreign authority's MCAI might have been issued some time before the
FAA AD. Therefore, the DOA might have provided U.S. operators with an
approved repair, developed with full awareness of the unsafe condition,
before the FAA AD is issued. Under these circumstances, to comply with
the FAA AD, the operator would be required to go back to the
manufacturer's DOA and obtain a new approval document, adding time and
expense to the compliance process with no safety benefit.
    Based on these comments, we removed the requirement that the DAH-
provided repair specifically refer to this AD. Before adopting such a

requirement, the FAA will coordinate with affected DAHs and verify they
are prepared to implement means to ensure that their repair approvals
consider the unsafe condition addressed in this AD. Any such
requirements will be adopted through the normal AD rulemaking process,
including notice-and-comment procedures, when appropriate. We also have
decided not to include a generic reference to either the ``delegated
agent'' or ``DAH with State of Design Authority design organization
approval,'' but instead we have provided the specific delegation
approval granted by the State of Design Authority for the DAH in the
Contacting the Manufacturer paragraph of this AD.

Conclusion

    We reviewed the relevant data and determined that air safety and
the public interest require adopting this AD with the changes described
previously and minor editorial changes. We have determined that these
minor changes:
     Are consistent with the intent that was proposed in the
NPRM (79 FR 6109, February 3, 2014) for correcting the unsafe
condition; and
     Do not add any additional burden upon the public than was
already proposed in the NPRM (79 FR 6109, February 3, 2014).
    We also determined that these changes will not increase the
economic burden on any operator or increase the scope of this AD.

Costs of Compliance

    We estimate that this AD affects 4 airplanes of U.S. registry.
    We also estimate that it will take about 12 work-hours per product
to comply with the basic requirements of this AD. The average labor
rate is $85 per work-hour. Required parts will cost about $10,000 per
product. Based on these figures, we estimate the cost of this AD on
U.S. operators to be $44,080, or $11,020 per product.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. 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.
    We are issuing this rulemaking under the authority described in
``Subtitle VII, Part A, Subpart III, Section 44701: General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    We determined that this AD will not have federalism implications
under Executive Order 13132. This AD will not have a substantial direct
effect on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government.
    For the reasons discussed above, I certify that this AD:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979);
    3. Will not affect intrastate aviation in Alaska; and
    4. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov/#!docketDetail;D=FAA-2014-0007; or in person at the
Docket Management Facility between 9 a.m. and 5 p.m., Monday through
Friday, except Federal holidays. The AD docket contains this AD, the
regulatory evaluation, any comments received, and other information.
The street address for the Docket Operations office (telephone 800-647-
5527) is in the ADDRESSES section.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

Adoption of the Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority:  49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive (AD):

2014-13-13 Fokker Services B.V.: Amendment 39-17889. Docket No. FAA-
2014-0007; Directorate Identifier 2012-NM-038-AD.

(a) Effective Date

    This AD becomes effective September 2, 2014.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Fokker Services B.V. Model F.28 Mark 0070 and
0100 airplanes, certificated in any category, all serial numbers.

(d) Subject

    Air Transport Association (ATA) of America Code 52, Doors.

(e) Reason

    This AD was prompted by reports that the bracket of the rod in
the carbon fiber reinforced plastic (CFRP) main landing gear (MLG)
outboard door had detached. In addition, we received reports of
broken recessed heads on titanium attachment bolts of the operating
rod brackets on the modified CFRP MLG outboard doors. We are issuing
this AD to detect and correct the affected MLG from moving to the
down and locked position, which could result in MLG collapse during
landing or roll-out, and consequent damage to the airplane and
injury to passengers.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Inspection

    Within 9 months after the effective date of this AD, do a
detailed inspection of the CFRP MLG outboard door for play and
cracks in the recessed countersunk heads of the operating rod
bracket attachment bolts, in accordance with Part 1 of the
Accomplishment Instructions of Fokker Service Bulletin SBF100-52-
090, dated November 17, 2011, including Fokker Manual Change
Notification F100-147, dated October 28, 2011, as revised by Fokker
Service Bulletin Change Notification SBF100-52-090/01, dated January
24, 2012.

(h) Corrective Action

    If, during the inspection required by paragraph (g) of this AD,
any play or crack is found in any countersunk bolt head, and the
configuration deviation list (CDL) item 52-07 cannot be applied:
Before further flight, replace the bolt with a new bolt, in
accordance with the Accomplishment Instructions of Fokker Service
Bulletin SBF100-52-090, dated November 17, 2011, including Fokker
Manual Change Notification F100-147, dated October 28, 2011, as
revised by Fokker Service Bulletin Change Notification SBF100-52-
090/01, dated January 24, 2012.

(i) Modification Prior to CFRP Door Installation

    At the applicable time specified in paragraph (i)(1) or (i)(2)
of this AD: Modify the CFRP MLG outboard doors and attachment to the
MLG, in accordance with Part 2 of the Accomplishment Instructions of
Fokker Service Bulletin SBF100-52-090, dated November 17, 2011,
including Fokker Manual Change Notification F100-147, dated October
28, 2011, as revised by Fokker Service Bulletin Change Notification
SBF100-52-090/01, dated January 24, 2012. Accomplishing the
modification in this paragraph terminates the inspection required by
paragraph (g) of this AD.
    (1) For airplanes on which a CFRP MLG outboard door is installed
as of the effective date of this AD: Do the modification within 24
months after the effective date of this AD.
    (2) For airplanes on which an aluminum door is installed as of
the effective date of this AD: Do the modification prior to the
installation of the CFRP MLG outboard door.

    Note 1 to paragraph (i) of this AD:  The aluminum MLG outboard
doors and the CFRP MLG outboard doors are two-way interchangeable.

(j) Parts Installation Prohibition

    As of the effective date of this AD, do not install on any
airplane an MLG outboard door having part number (P/N) D13310-401
through -418, or any MLG outboard door assembly having P/N D13312-
401 through -410.

    Note 2 to paragraph (j) of this AD:  Civil Aviation Authority-
Netherlands (CAA-NL) AD NL-2006-001, dated January 5, 2006 (European
Aviation Safety Agency (EASA) approval 2006-002), contains guidance
for modifying spare MLG outboard door assemblies having P/N D13312-
401 through -410, to P/N D13312-7XX standard, as specified in the
Accomplishment Instructions of Fokker Component Service Bulletin
D13312-52-09, December 12, 2005, which is not incorporated by
reference in this AD.

(k) Parts Installation Limitation

    As of the effective date of this AD, do not install on any
airplane a P/N D13310-701 through -708 MLG outboard door, or a P/N
D13312-702 through -711 MLG outboard door assembly, unless the part
has been inspected for cracks in the recessed bolt heads, all
applicable corrective actions have been done, and the CFRP MLG
outboard door has been modified, in accordance with the
Accomplishment Instructions of Fokker Component Service Bulletin
D13312-52-015, dated November 17, 2011.

(l) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
has the authority to approve AMOCs for this AD, if requested using
the procedures found in 14 CFR 39.19. In accordance with 14 CFR
39.19, send your request to your principal inspector or local Flight
Standards District Office, as appropriate. If sending information
directly to the International Branch, send it to ATTN: Tom
Rodriguez, Aerospace Engineer, International Branch, ANM-116,
Transport Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton,
WA 98057-3356; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>. Information
may be emailed to<EMAIL_ADDRESS>Before using any
approved AMOC, notify your appropriate principal inspector, or
lacking a principal inspector, the manager of the local flight
standards district office/certificate holding district office. The
AMOC approval letter must specifically reference this AD.
    (2) Contacting the Manufacturer: For any requirement in this AD
to obtain corrective actions from a manufacturer, the action must be
accomplished using a method approved by the Manager, International
Branch, ANM-116, Transport Airplane Directorate, FAA; or the EASA;
or Fokker Services B.V.'s EASA Design Organization Approval (DOA).
If approved by the DOA, the approval must include the DOA-authorized
signature.

(m) Related Information

    (1) Refer to Mandatory Continuing Airworthiness Information EASA
Airworthiness Directive 2012-0023, dated February 6, 2012, for
related information. This MCAI may be found in the AD docket on the
Internet at http://www.regulations.gov/#!documentDetail;D=FAA-2014-
0007-0002.
    (2) Service information identified in this AD that is not
incorporated by reference may be viewed at the addresses specified
in paragraphs (n)(3) and (n)(4) of this AD.

(n) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless this AD specifies otherwise.
    (i) Fokker Component Service Bulletin D13312-52-015, dated
November 17, 2011.
    (ii) Fokker Service Bulletin SBF100-52-090, dated November 17,
2011, including Fokker Manual Change Notification F100-147, dated
October 28, 2011.
    (iii) Fokker Service Bulletin Change Notification SBF100-52-090/
01, dated January 24, 2012. The page number shown on the first page
of this document should read ``Page 1 of 2.''
    (3) For service information identified in this AD, contact
Fokker Services B.V., Technical Services Dept., P.O. Box 1357, 2130
EL Hoofddorp, the Netherlands; telephone +31 (0)88-6280-350; fax +31
(0)88-6280-111; email<EMAIL_ADDRESS>Internet http://www.myfokkerfleet.com.
    (4) You may view this service information at the FAA, Transport
Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For
information on the availability of this material at the FAA, call
425-227-1221.
    (5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Renton, Washington, on June 25, 2014.
Jeffrey E. Duven,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2014-17297 Filed 7-25-14; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 88, Number 192 (Thursday, October 5, 2023)]
[Notices]
[Pages 69205-69207]
[FR Doc No: 2023-22189]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-D-1848]

Stimulant Use Disorders: Developing Drugs for Treatment; Draft
Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled ``Stimulant
Use Disorders: Developing Drugs for Treatment.'' The purpose of this
draft guidance is to assist sponsors in the clinical development of
drugs for the treatment of stimulant use disorders. Specifically, this
guidance addresses FDA's current recommendations regarding the overall
development program and clinical trial designs for the development of
drugs to support indications of treatment of moderate to

severe cocaine use disorder, treatment of moderate to severe
methamphetamine use disorder, or treatment of moderate to severe
prescription stimulant use disorder.

DATES: Submit either electronic or written comments on the draft
guidance by December 4, 2023 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as
follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://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 https://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): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, 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-2023-D-1848 for ``Stimulant Use Disorders: Developing Drugs for
Treatment.'' Received comments will be placed in the docket and, except
for those submitted as ``Confidential Submissions,'' publicly viewable
at https://www.regulations.gov or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     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 https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. 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: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://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 Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the draft 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. Send one
self-addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Matthew Sullivan, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 3126, Silver Spring, MD 20993-0002, 301-
796-1245.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Stimulant Use Disorders: Developing Drugs for Treatment.''
The purpose of this draft guidance is to assist sponsors in the
clinical development of drugs for the treatment of stimulant use
disorders. This draft guidance is intended to serve as a focus for
continued discussions among the Division of Anesthesiology, Addiction
Medicine, and Pain Medicine, pharmaceutical sponsors, the academic
community, and the public. This draft guidance does not address
treatment of intoxication or poisoning with various stimulants or
treatment of withdrawal from stimulants.
    Because FDA has yet to approve any medication treatments for
stimulant use disorders, this guidance reflects current recommendations
based on a number of uncertainties about the best approach for treating
stimulant use disorders and the best approach for evaluating response
to treatment. FDA is engaged in an ongoing process to learn more about
stimulant use disorders and their treatments to provide the best
possible advice to sponsors.
    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 current thinking of FDA on ``Stimulant
Use Disorders: Developing Drugs for Treatment.'' 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. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. The
previously approved collections of information are subject to review by
the Office of Management and Budget (OMB) under the Paperwork Reduction
Act of 1995 (PRA) (44 U.S.C. 3501-3521). The collections of information
in 21 CFR part 312 relating to the submission of investigational new
drug applications have been approved under OMB control number 0910-
0014. The collections of information in 21 CFR part 314 relating to the
submission of new drug applications have been approved under OMB
control number

0910-0001. The collections of information in 21 CFR 201.56 and 201.57
relating to certain prescription product labeling requirements have
been approved under OMB control number 0910-0572. The collections of
information pertaining to expedited programs for serious conditions for
drugs and biologics and breakthrough therapy-designation for drugs and
biologics have been approved under OMB control number 0910-0765.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance
at https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    Dated: October 2, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-22189 Filed 10-4-23; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 77, Number 65 (Wednesday, April 4, 2012)]
[Notices]
[Pages 20471-20472]
[FR Doc No: 2012-8036]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-66677; File No. SR-C2-2012-006]

 Self-Regulatory Organizations; C2 Options Exchange,
Incorporated; Order Approving Proposed Rule Change Relating to Its
Automated Improvement Mechanism

March 29, 2012.
    On January 31, 2012, the C2 Options Exchange, Incorporated
(``Exchange'') filed with the Securities and Exchange Commission
(``Commission''), pursuant to Section 19(b)(1) of the Securities
Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4 thereunder,\2\ a
proposed rule change to amend C2 Rule 6.51, which relates to the
Exchange's Automated Improvement Mechanism (``AIM''). The proposal
would permit a participant (``Participant''), when submitting an agency
order to AIM to initiate an auction against a single price submission,
to elect to have last priority in the AIM auction's order
allocation.\3\
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ In an AIM auction, described here generally, a Participant
submits into the mechanism an order that it represents as agent
(``Agency Order'') along with a contra-side order at a specified
price (which must comply with parameters set forth in Rule 6.51) and
for the same size that either represents principal interest of the
Participant or is a solicited order. Certain Participants, as set
forth in Rule 6.51, then can compete with the contra-side order by
submitting bids (offers) to execute against the Agency Order. After
better-priced orders are filled and public customers competing at
the best price receive their allocations, the Participant is granted
priority ahead of other participants to execute against 40% (in some
circumstances 50%) of the original size of the Agency Order. Under
the proposed rule change, the initiating Participant will be able to
elect to have last priority.
---------------------------------------------------------------------------

    The proposed rule change was published for comment in the Federal
Register on February 17, 2012.\4\ The Commission received no comments
on the proposal.
---------------------------------------------------------------------------

    \4\ See Securities Exchange Act Release No. 66384 (February 13,
2012), 77 FR 9717.
---------------------------------------------------------------------------

    After careful review, the Commission finds that the proposed rule
change is consistent with the requirements of the Act and the rules and
regulations thereunder applicable to a national securities exchange \5\
and, in particular, the requirements of Section 6(b)(5) of the Act,\6\
in that it is designed to provide additional flexibility for
Participants to obtain executions on behalf of their customers through
AIM because the initiating Participants may elect to have

last priority. The Commission believes that, as a result of this
flexibility, there may be increased usage of AIM auctions and the
mechanism may attract new participants, thereby helping to further
competition and to enhance the possibility of price improvement on
behalf of customers.\7\
---------------------------------------------------------------------------

    \5\ In approving this proposed rule change, the Commission has
considered the proposed rule's impact on efficiency, competition,
and capital formation. See 15 U.S.C. 78c(f).
    \6\ 15 U.S.C. 78f(b)(5).
    \7\ The Commission notes that Chapter V, Section 18(f)(v) of the
Rules of the Boston Exchange Group, LLC, ``The Price Improvement
Period'' (``PIP''), includes a similar provision that permits an
options participant initiating a PIP auction to designate a lower
amount than the 40% to which it is otherwise entitled upon the
conclusion of the PIP auction. The Commission also recently approved
a similar provision under Rule 6.74A of the Chicago Board of Options
Exchange, Incorporated, with respect to its AIM auction. See
Securities Exchange Act Release No. 66375 (February 10, 2012), 77 FR
9274 (February 16, 2012) (SR-CBOE-2011-117).
---------------------------------------------------------------------------

    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\8\ that the proposed rule change (SR-C2-2012-006) be, and it
hereby is, approved.
---------------------------------------------------------------------------

    \8\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\9\
---------------------------------------------------------------------------

    \9\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2012-8036 Filed 4-3-12; 8:45 am]
BILLING CODE 8011-01-P


From<EMAIL_ADDRESS>Sent:	Wednesday, July 28, 2010 1:35 PM
To<EMAIL_ADDRESS>Cc<EMAIL_ADDRESS><EMAIL_ADDRESS>
<EMAIL_ADDRESS><EMAIL_ADDRESS>
<EMAIL_ADDRESS><EMAIL_ADDRESS>Subject:	SI RICE NESHAP cost breakout by subcategory
Attachments:	Existing SI RICE NESHAP cost breakdown by subcategory 7-28-10.xls

Cortney,
The attached spreadsheet shows the cost breakout by subcategory.
(See attached file: Existing SI RICE NESHAP cost breakdown by subcategory 7-
28-10.xls)

Melanie King
Energy Strategies Group
Sector Policies and Programs Division
Office of Air Quality Planning and Standards U.S. Environmental Protection
Agency

Mail Code D243-01
RTP, NC  27711

Phone:<PHONE_NUMBER>
Fax:<PHONE_NUMBER>
<EMAIL_ADDRESS>