[Federal Register: August 24, 2006 (Volume 71, Number 164)]
[Notices]
[Page 50054-50055]
[DOCID:fr24au06-42]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP06-430-000]

Columbia Gas Transmission Corporation; Notice of Application

August 17, 2006.
    Take notice that on August 15, 2006, Columbia Gas Transmission
Corporation (Columbia), 1700 MacCorkle Avenue, SE., Charleston, West
Virginia, filed in Docket No. CP06-430-000 an application pursuant to
Section 7 of the Natural Gas Act (NGA), as amended, for authorization
to permit Columbia to increase the maximum volume of gas in storage in
certain storage fields in Bedford and Washington Counties,
Pennsylvania; Kanawha, Randolph, Pocahontas, Putnam, and Preston
Counties, West Virginia; and Hocking and Lorain Counties, Ohio, on a
temporary basis from August 2006 to April 2007, to a level above the
amount currently certificated by the Commission, all as more fully set
forth in the application which is on file with the Commission and open
to public inspection. This filing may also be viewed on the
Commission's Web site at http://www.ferc.gov using the ``eLibrary''

link. Enter the docket number, excluding the last three digits, in the
docket number field to access the document. For assistance, call (202)
502-8659 or TTY,<PHONE_NUMBER>.
    Any questions regarding this application should be directed to
Fredric J. George, Lead Counsel, Columbia Gas Transmission Corporation,
P.O. Box 1273, Charleston West Virginia 25325-1273; telephone (304)
357-2359, fax<PHONE_NUMBER>.
    There are two ways to become involved in the Commission's review of
this project. First, any person wishing to obtain legal status by
becoming a party to the proceedings for this project should, on or
before the comment date stated below, file with the Federal Energy
Regulatory Commission, 888 First Street, NE., Washington, DC 20426, a
motion to intervene in accordance with the requirements of the
Commission's Rules of Practice and Procedure (18 CFR 385.214 or
385.211) and the Regulations under the NGA (18 CFR 157.10). A person
obtaining party status will be placed on the service list maintained by
the Secretary of the Commission and will receive copies of all
documents filed by the applicant and by all other parties. A party must
submit 14 copies of filings made with the Commission and must mail a
copy to the applicant and to every other party in the proceeding. Only
parties to the proceeding can ask for court review of Commission orders
in the proceeding.
    However, a person does not have to intervene in order to have
comments considered. The second way to participate is by filing with
the Secretary of the Commission, as soon as possible, an original and
two copies of comments in support of or in opposition to this project.
The Commission will consider these comments in determining the
appropriate action to be taken, but the filing of a comment alone will
not serve to make the filer a party to the proceeding. The Commission's
rules require that persons filing comments in opposition to the project
provide copies of their protests only to the party or parties directly
involved in the protest.
    Persons who wish to comment only on the environmental review of
this project should submit an original and two copies of their comments
to the Secretary of the Commission. Environmental commentors will be
placed on the Commission's environmental mailing list, will receive
copies of the environmental documents, and will be notified of meetings
associated with the Commission's environmental review process.
Environmental commentors will not be required to serve copies of filed
documents on all other parties. However, the non-party commentors will
not receive copies of all documents filed by other parties or issued by
the

Commission (except for the mailing of environmental documents issued by
the Commission) and will not have the right to seek court review of the
Commission's final order.
    The Commission strongly encourages electronic filings of comments
protests and interventions via the Internet in lieu of paper. See 18
CFR 385.2001(a)(1)(iii) and the instructions on the Commission's Web
site (http://www.ferc.gov) under the ``e-Filing'' link.

    Comment Date: 5 p.m. Eastern Time on August 24, 2006.

Magalie R. Salas,
Secretary.
 [FR Doc. E6-14009 Filed 8-23-06; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 80, Number 225 (Monday, November 23, 2015)]
[Notices]
[Pages 73019-73024]
[FR Doc No: 2015-29707]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-76452; File No. SR-Phlx-2015-93]

Self-Regulatory Organizations; NASDAQ OMX PHLX LLC; Notice of
Filing and Immediate Effectiveness of Proposed Rule Change Relating to
Sponsored Access

November 17, 2015.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on November 4, 2015, NASDAQ OMX PHLX LLC (``Phlx'' or ``Exchange'')
filed with the Securities and Exchange Commission (``SEC'' or
``Commission'') the proposed rule change as described in Items I, II,

and III, below, which Items have been prepared by the Exchange. The
Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to amend Rule 1094, entitled ``Sponsored
Participants'' (1) define the term ``Sponsored Access'' and ``Customer
Agreement;'' (2) specify the requirements to comply with Rule 15c3-5
under the Securities Exchange Act of 1934 (``Market Access Rule''); (3)
remove the requirement that each Sponsored Participant and each
Sponsoring Member Organization must enter into certain agreements with
the Exchange; and (4) remove PSX Rule 3211 as well as certain
definitions.
    The text of the proposed rule change is available on the Exchange's
Web site at http://nasdaqomxphlx.cchwallstreet.com/, at the principal
office of the Exchange, and at the Commission's Public Reference Room.

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

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

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

1. Purpose
    The purpose of the filing is to amend Rule 1094 entitled,
``Sponsored Participants'' to: (1) Define the term ``Sponsored
Access,'' and specifically stating that compliance with the Market
Access Rule is required, and defining ``Customer Agreement'' to refer
to the agreement that must be executed between the Sponsoring
Participant and the Sponsoring Member Organization; (2) specify the
requirements to comply with the Market Access Rule; (3) remove the
requirement that each Sponsored Participant and each Sponsoring Member
Organization must enter into certain agreements with the Exchange to
streamline its rule and remove unnecessarily burdensome notice
requirements to the Exchange; and (4) remove PSX Rule 3211, entitled
``Application of Other Rules of the Exchange,'' because Phlx Rule 1094
will be applicable to market participants trading on PSX, and remove
the definitions of Sponsored Participant and Sponsoring Member
Organization in Rule 1, which relate to PSX Rules.
Defining Sponsored Access
    A Sponsored Participant may be a member or a non-member of the
Exchange, such as an institutional investor, that gains access to the
Exchange \3\ and trades under a Sponsoring Member Organization's
execution and clearing identity pursuant to sponsorship arrangements
currently set forth in Phlx Rule 1094. The Exchange is proposing to
define the term ``Sponsored Access'' to clarify the type of market
access arrangement that is subject to Phlx Rule 1094. The Exchange
proposes to amend Phlx Rule 1094(a) to add the following definition,
``Sponsored Access shall mean an arrangement whereby a member
organization permits its customers to enter orders into the Exchange's
trading system that bypass the member organization's trading system and
are routed directly to the Exchange, including routing through a
service bureau or other third party technology provider.'' This
definition was derived from the Commission's description of Sponsored
Access used in the release approving the Market Access Rule.\4\ The
Exchange believes that defining Sponsored Access in Phlx Rule 1094 will
provide market participants with greater clarity concerning Sponsored
Access and their obligations with respect to this type of access
arrangement.
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    \3\ For example, a broker-dealer may allow its customer--whether
an institution such as a hedge fund, mutual fund, bank or insurance
company, an individual, or another broker-dealer--to use the broker-
dealer's MPID, account or other mechanism or mnemonic used to
identify a market participant for the purposes of electronically
accessing the Exchange.
    \4\ The Market Access Rule, among other things, requires broker-
dealers providing others with access to an exchange or alternative
trading system to establish, document, and maintain a system of risk
management controls and supervisory procedures reasonably designed
to manage the financial, regulatory, and other risks of providing
such access. See Securities Exchange Act Release No. 63241 (November
3, 2010), 75 FR 69792 (November 15, 2010).
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Defining Customer Agreement
    The Exchange proposes to amend Phlx Rule 1094(b)(i) to define the
agreement that Sponsored Participants must enter into and maintain with
one or more Sponsoring Member Organizations to establish proper
relationship(s) and account(s) through which the Sponsored Participant
may trade on the Exchange, as a ``Customer Agreement.''
Market Access Rule
    Pursuant to Phlx Rule 1094, the Sponsoring Member Organization is
responsible for the activities of the Sponsored Participant. Sponsored
Participants are required to have procedures in place to comply with
Exchange rules, and the Sponsoring Member Organization takes
responsibility for the Sponsored Participant's activity on the
Exchange. Members may have multiple Sponsored Access relationships in
place at a given time. The Exchange's examination program assesses
compliance with Phlx Rule 1094, among other rules.\5\ The Exchange
proposes to specifically enumerate within Phlx Rule 1094 the member's
obligation to comply with the Market Access Rule, which members are
currently required to comply with respecting market access. The
Exchange believes that specifying the obligation to comply with the
Market Access Rule specifically will reinforce that Phlx Rule 1094
presupposes member compliance with the Market Access Rule.
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    \5\ The Exchange has a Regulatory Services Agreement with
Financial Industry Regulatory Authority (``FINRA'') to conduct
regulatory examinations, among other obligations.
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Elimination of Certain Contract Requirements
    At this time, the Exchange proposes to remove requirements to
submit certain forms to the Exchange. There are three forms that are
currently required by Phlx Rule 1094: (1) An agreement between the
Sponsored Participant and the Exchange (``Exchange Agreement''); (2) an
Access Agreement between the Sponsored Participant and its Sponsoring
Member Organization that is provided to the Exchange; and (3) a
Sponsored Participant Addendum to its Access Agrement (hereinafter
``addendum'') provided to the Exchange by the Sponsoring Member
Organization. Phlx Rule 1094 will continue to require that each
Sponsored Participants enter into a Customer Agreement with each
Sponsoring member to establish proper relationship(s) and account(s)
through which the Sponsored Participant may trade on the Exchange.
These Customer Agreement(s) must incorporate the Sponsorship Provisions
set forth in

paragraph (ii) in Phlx Rule 1094.\6\ The Customer Agreement remains
unaffected by this rule proposal. Also, the Exchange is proposing to
amend Phlx Rule 1094 to identify the aforementioned agreement as the
``Customer Agreement.''
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    \6\ The Customer Agreement is required to include, among other
language, all orders entered by the Sponsored Participants and any
person acting on behalf of or in the name of such Sponsored
Participant and any executions occurring as a result of such orders
are binding in all respects on the Sponsoring Member Organization
and, also, Sponsoring Member Organization is responsible for any and
all actions taken by such Sponsored Participant and any person
acting on behalf of or in the name of such Sponsored Participant.
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    Today, only members may request connectivity to the Exchange. A
member may obtain one or more ports for the purpose of providing
Sponsored Access. If separate ports are requested by a member for the
purpose of providing Sponsored Access, the member must request those
ports from the Exchange and the member is responsible for the Sponsored
Participant's activity on the Exchange. In all circumstances, the
Exchange will only permit members to request connectivity to the market
and the member is responsible for all customer orders submitted through
the member's port.
    First, the Exchange believes that completing and submitting the
Exchange Agreement, Access Agreement and Addendum is unnecessarily
burdensome in light of the current structure in place at the Exchange.
Only members may request connectivity to the Exchange by contacting
Phlx Subscriber Services. Such connection by the member requires
approval by the Exchange for the purpose of testing as well as other
relevant information sharing with the Exchange by the member to obtain
a port. The Exchange is aware of the member responsible for each of its
ports, however the Exchange may not be aware of the member's Sponsored
Access arrangements due to varied ways that a member may utilize a
port. The Exchange believes the requirement to also complete and submit
an Exchange Agreement, Access Agreement and Addendum with our Phlx
Membership Department is viewed as unnecessarily burdensome by members
because of the multitude of relationships the member has with various
customers. Members have expressed to the Exchange that they have
multiple relationships with customers, which customer relationships
change over time.\7\ Members have indicated that the necessity to
continuously disclose the updated customer relationships to the
Exchange is burdensome and unnecessary as they remain responsible for
all activity conducted on the Exchange through a port assigned to the
member. Further such information is available to the Exchange upon
Exchange request from its regulatory group.\8\
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    \7\ For example, a broker-dealer's customers, which could
include hedge funds, institutional investors, individual investors,
and other broker-dealers.
    \8\ See Phlx Rule 960.2.
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    Second, the Exchange believes that the Exchange Agreement between
the Sponsored Participant and the Exchange is also unnecessarily
burdensome. The requirement to provide this form was intended to give
the Exchange notification that such a relationship existed and to
ensure that the Sponsored Participant was informed of the Exchange's
Limited Liability Company Agreement, By-Laws, Rules and procedures. The
agreements also provided the Exchange with contractual privity, which
would no longer exist with the removal of the Exchange Agreement. The
Exchange does not believe the loss of privity with the Sponsored
Participant creates a concern as the Exchange has the ability to remove
access to the port \9\ at any time if the activity of the Sponsored
Participant warrants such removal. In addition, as discussed below, the
Sponsored Participant will be made aware of its obligations through the
Customer Agreement that it executed with the Sponsoring Member. As
noted above, the Exchange only permits its members to request
connectivity to the Exchange's System and members responsible for all
trades submitted through such ports. Pursuant to Phlx Rule 1094 the
trading activity of a Sponsored Participant must be monitored by the
Sponsoring Member Organization for compliance with the terms of the
Customer Agreement with the Sponsoring Participant.\10\ Finally, the
member continues to be obligated to comply with Phlx Rule 1094 and the
Market Access Rule. The Sponsoring Member Organiztion is responsible
for any and all actions taken by such Sponsored Participant and any
person acting on behalf of or in the name of such Sponsored
Participant.
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    \9\ Phlx Rule 911, entitled ``Member and Member Organization
Participation'' permits the Exchange to impose upon any member or
member organization such temporary restrictions upon the automated
entry or updating of orders or quotes/orders as the Exchange may
determine to be necessary to protect the integrity of Exchange's
systems.
    \10\ See Phlx Rule 1094(b)(ii)(G).
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    Phlx Rule 1094 requires that the Sponsored Participant and the
Sponsored Member Organization maintain a Customer Agreement to ensure
compliance with the Exchange's Rules and obligations related to
security, among other things.\11\ Phlx Rule 1094 requires that the
Customer Agreement specify that the Sponsored Participant shall
maintain, keep current and provide to the Sponsoring Member a list of
individuals authorized to obtain access to the Exchange on behalf of
the Sponsored Participant and provide appropriate training. In
addition, pursuant to the Customer Agreement provisions, the Sponsored
Participant is required to take reasonable security precautions to
prevent unauthorized use or access to the Exchange, including
unauthorized entry of information into the Exchange, or the information
and data made available therein. Finally, the Customer Agreement must
provide that the Sponsored Participant is responsible for any and all
orders, trades and other messages and instructions entered, transmitted
or received under identifiers, passwords and security codes of
authorized individuals, and for the trading and other consequences
thereof, including granting unauthorized access to the Exchange. The
contents and the requirement for a Customer Agreement are unchanged.
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    \11\ See Phlx Rule 1094(b)(ii)(B).
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    Pursuant to Phlx Rule 1094 the Sponsoring Member Organization must
provide an Addendum to the Exchange. The Exchange believes that the
Addendum provided to the Exchange by the Sponsoring Member Organization
is also unnecessarily burdensome. The Addendum notifies the Exchange of
the relationship between the Sponsoring Member Organization and the
Sponsored Participant. However, as noted above, the Exchange's
regulatory group may request information about a particular customer
relationship as it deems necessary.\12\ Further, the Exchange is made
aware of the existence of ports when the Sponsoring Member Organization
requests connectivity to the Exchange and the Members are responsible
for all trading activity by its Sponsored Participant. In addition, the
Exchange, through its Regulatory Services Agreement with the Financial
Industry Regulatory Authority (FINRA), reviews for member compliance
with Phlx Rule 1094 and the Market Access Rule. The Exchange has the
ability to remove access to the port \13\ at any time if the activity
of the Sponsored Participant would warrant such removal.
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    \12\ See Phlx Rule 960.2.
    \13\ See note 9.
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    In light of the foregoing, the requirement to complete and submit
an

Exchange Agreement and Addendum with the Phlx Membership Department is
viewed as unnecessarily burdensome by members, who must update their
customer relationships internally and provides such information upon
Exchange request.
PSX Rules
    The Exchange proposes to remove PSX Rule 3211, entitled
``Application of Other Rules of the Exchange,'' because Phlx Rule 1094
will be applicable to market participants trading on PSX. The Exchange
is adding Phlx Rule 1094 to the list of Phlx Rules for which PSX are
responsible for compliance. Finally, the Exchange is removing the
definitions of Sponsored Participant and Sponsoring Member Organization
in Rule 1, which relate to PSX Rules.
2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act \14\ in general, and furthers the objectives of Section
6(b)(5) of the Act \15\ in particular, in that it is designed to
promote just and equitable principles of trade, to remove impediments
to and perfect the mechanism of a free and open market and a national
market system, and, in general to protect investors and the public
interest, by enhancing the risk protections available to Exchange
members.
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    \14\ 15 U.S.C. 78f(b).
    \15\ 15 U.S.C. 78f(b)(5).
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Defining Sponsored Access
    Adding a definition of Sponsored Access will assist market
participants to understand the type of arrangements that are subject to
Phlx Rule 1094 and such clarity will serve to promote just and
equitable principles of trade. Members have indicated, and the Exchange
believes, that adding the Sponsored Access definition will provide
members with additional guidance with respect to Phlx Rule 1094.
Defining Customer Agreement
    Defining the agreement that Sponsored Participants must enter into
and maintain with one or more Sponsoring Member Organizations to
establish proper relationship(s) and account(s) through which the
Sponsored Participant may trade on the Exchange, as a ``Customer
Agreement'' will also serve to provide members with clarity on the
agreement that the Exchange will continue to require and the
obligations that are contained within the Customer Agreement. This
amendment is non-substantive.
Market Access Rule
    Members continue to be required to comply with Phlx Rule 1094 and
the Market Access Rule. The Exchange believes that specifically
enumerating the member's responsibility to comply with the Market
Access Rule will provide member's with additional guidance concerning
the application of the Rule. This change is non-substantive as members
are currently responsible to comply with the Market Access Rule.
Elimination of Certain Contract Requirements
    Removing the requirement to submit and complete an Exchange
Agreement, Access Agreement and Addendum will remove impediments to and
perfect the mechanism of a free and open market by removing a
burdensome and time-consuming requirement for members. While
elimination of the Exchange Agreement requirement will also eliminate
the Exchange's contractual privity with the Sponsored Participant, he
Exchange notes that any potential concerns to the loss of privity are
mitigated by the Exchange's ability to restrict the Sponsored
Participant's access to a port \16\ at any time it is warranted by the
Sponsored Participant's trading activity. Also, members have indicated
that customer relationships must be frequently updated and it is
unnecessarily burdensome to continuously update the Exchange with this
information that is available upon request. Connectivity to the
Exchange is authorized by the Exchange and must be requested by a
member of the Exchange. Such connection requires approval by the
Exchange, testing and other security features as well as information
sharing with the Exchange by the member. In addition, Phlx Rule 1064
delineates the terms of the required contractual relationship between
the Sponsoring Member Organization and the Sponsored Participant in the
Customer Agreement, which remains in effect. The Exchange believes that
the Addendum is unnecessary as Sponsoring Member Organizations must
request connectivity to the Exchange as well as enter into a Customer
Agreement with the Sponsored Participant. Finally, as is the case with
other Exchange Rules, the Exchange examines for compliance with Phlx
Rule 1064 and may request information about any customer relationship
which concerns the Exchange.
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    \16\ See note 9.
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    The requirement to also complete and submit an Exchange Agreement,
Access Agreement and Addendum with our Phlx Membership Department is
viewed as unnecessarily burdensome by members, who must update their
customer relationships internally.
PSX Rules
    The Exchange's proposal to remove PSX Rule 3211, entitled
``Application of Other Rules of the Exchange,'' and add Phlx Rule 1094
to the list of Phlx Rules for which PSX are responsible for compliance
will continue to treat both Phlx equities and options members in a
similar manner, pursuant to the same rule. Eliminating the definitions
of Sponsored Participant and Sponsoring Member Organization in Rule 1
will avoid confusion.

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

    The Exchange does not believe that the proposed rule change will
impose any burden on competition not necessary or appropriate in
furtherance of the purposes of the Act for the reasons below.
Defining Sponsored Access
    The addition of a definition for Sponsored Access will assist
market participants to understand the type of arrangement subject to
Phlx Rule 1094 and such clarity will serve to promote just and
equitable principles of trade.
Defining Customer Agreement
    Defining the agreement that Sponsored Participants must enter into
and maintain with one or more Sponsoring Member Organizations to
establish proper relationship(s) and account(s) through which the
Sponsored Participant may trade on the Exchange, as a ``Customer
Agreement'' does not create an undue burden on competition as this
amendment is non-substantive and the Exchange believes that providing
guidance concerning the type of arrangement subject to Phlx Rule 1094
will facilitate member compliance and does not unduly burden
competition.
Market Access Rule
    In addition, the Exchange believes that specifically enumerating
the member's obligation to comply with the Market Access Rule does not
create an undue burden on competition, but rather reinforces the
application of the Rule. This change is non-substantive as members are
currently responsible to comply with the Market Access Rule.

Elimination of Certain Contract Requirements
    Removing the requirement to complete an Exchange Agreement, Access
Agreement and Addendum under Phlx Rule 1094 does not create an undue
burden on competition. The Exchange believes that this requirement is
unnecessarily burdensome as the Exchange's regulatory group may request
information about a particular customer relationship as it deems
necessary.\17\ Further, the Exchange is made aware of the existence of
ports when the Sponsoring Member Organization requests connectivity to
the Exchange and the Members are responsible for all trading activity
by its Sponsored Participant. In order to obtain connectivity to the
Exchange, members are required to contact Phlx Subscriber Services and
request a connection to the market. Such connection requires approval
by the Exchange, testing and other security features as well as
information sharing with the Exchange by the member. Only members are
permitted to request connectivity to the Exchange. The requirement to
also complete and submit an Exchange Agreement, Access Agreement and
Addendum with our Phlx Membership Department is viewed as unnecessarily
burdensome by members, who must update their customer relationships
internally. Additionally, the Exchange examines for compliance with
Phlx Rule 960.2 and may request information about any customer
relationship which concerns the Exchange.
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    \17\ See Phlx Rule 960.2.
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    The Sponsoring Member Organization remains responsible for customer
activity conducted on the Exchange through the Customer Agreement,
among other obligations. Additionally, Sponsored Participants that
obtain access to the Exchange's trading system are required to take
reasonable security precautions and prevent unauthorized use or access
the Exchange, including unauthorized entry of information to the
Exchange,\18\ pursuant to the Customer Agreement. Further, the
Sponsored Participants is responsible to establish adequate procedures
and controls that permit it to effectively monitor its employees',
agents' and customers' use and access to the Exchange for compliance
with the terms of this agreement.\19\ In addition, the Exchange,
through its Regulatory Services Agreement with FINRA conducts reviews
of members for compliance with Phlx Rule 1094 and the Market Access
Rule. The Exchange has the ability to remove access to the port \20\ at
any time if the activity of the Sponsored Participant would warrant
such removal. Finally, Phlx Rule 1094 is currently applicable to all
Phlx members that desire to sponsor access for its customers and
applies to trading in all securities on the Exchange.
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    \18\ See Phlx Rule 1094(b)(ii)(G).
    \19\ See Phlx Rule 1094(b)(ii)(H).
    \20\ See note 9.
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PSX Rules
    The Exchange's proposal to remove PSX Rule 3211, entitled
``Application of Other Rules of the Exchange,'' and add Phlx Rule 1094
to the list of Phlx Rules for which PSX are responsible for compliance
does not create an undue burden on competition because both Phlx
equities and options members will be obligated similarly to Rule 1094.
Eliminating the definitions of Sponsored Participant and Sponsoring
Member Organization in Rule 1 does not create an undue burden on
competition because it will avoid confusion.

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

    No written comments were either solicited or received.

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

    Because the foregoing proposed rule change does not: (i)
Significantly affect the protection of investors or the public
interest; (ii) impose any significant burden on competition; and (iii)
become operative for 30 days from the date on which it was filed, or
such shorter time as the Commission may designate, it has become
effective pursuant to Section 19(b)(3)(A)(iii) of the Act \21\ and
subparagraph (f)(6) of Rule 19b-4 thereunder.\22\
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    \21\ 15 U.S.C. 78s(b)(3)(a)(iii).
    \22\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)
requires a self-regulatory organization to give the Commission
written notice of its intent to file the proposed rule change at
least five business days prior to the date of filing of the proposed
rule change, or such shorter time as designated by the Commission.
The Exchange has satisfied this requirement.
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    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is: (i)
Necessary or appropriate in the public interest; (ii) for the
protection of investors; or (iii) otherwise in furtherance of the
purposes of the Act. If the Commission takes such action, the
Commission shall institute proceedings to determine whether the
proposed rule should be approved or disapproved.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-Phlx-2015-93 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-Phlx-2015-93. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549, on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of the filing also will be available
for inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-Phlx-2015-93 and should be
submitted on or before December 14, 2015.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\23\
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    \23\ 17 CFR 200.30-3(a)(12).
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Robert W. Errett,
Deputy Secretary.
[FR Doc. 2015-29707 Filed 11-20-15; 8:45 am]
BILLING CODE 8011-01-P


                           Supporting Statement for
                    An Information Collection Request (ICR)

 1.	IDENTIFICATION OF THE INFORMATION COLLECTION

      1(a)	Title of the Information Collection

      Submission of Protocols and Study Reports for Environmental Research Involving Human Subjects

      OMB No. 2070-0169   	EPA No. 2195.04

      1(b)	Short Characterization/Abstract
	The Environmental Protection Agency (EPA or the Agency) is responsible for the regulation of pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal Food, Drug, and Cosmetic Act (FFDCA).  The applicable Sections of FIFRA and FFDCA which authorize the information collection activities in this ICR are discussed in Section 2(a) of this document.  In January 2006, EPA issued a final rule to amend the Federal Policy for the Protection of Human Subjects (also known as the Common Rule) at 40 CFR part 26 (see Attachment A).  EPA's January 2006 final rule significantly strengthens and expands the protections for subjects of "third-party" human research (i.e., research that is not conducted or supported by EPA).  In addition to other protections, the final rule requires affected entities to submit information to EPA and an institutional review board (IRB) prior to initiating, and to EPA upon the completion of, certain studies that involve human research participants.
      The information collection activity imposed by this final rule consists of activity-driven reporting and recordkeeping requirements for those who intend to conduct research for submission to EPA under the pesticide laws.  If such research involves intentional dosing of human subjects, these individuals (respondents) are required to submit study protocols to EPA and a cognizant local Human Subjects IRB before such research is initiated so that the scientific design and ethical standards that will be employed during the proposed study may be reviewed and approved.  In addition, respondents are required to submit information about the ethical conduct of completed research that involved human subjects when such research is submitted to EPA.  This renewal ICR estimates the third party response burden from complying with the January 2006 final rule requirements. Information is typically submitted by registrants of pesticide products to support the registration of their products. It is estimated that the annual response burden is approximately 20,572 hours valued at about $1,712,833.

2.	NEED FOR AND USE OF THE COLLECTION

      2(a)	Need/Authority for the Collection

      The 2006 Appropriations Act, Pub. L. No. 109-54, required EPA to issue a final rule addressing third-party intentional dosing human toxicity studies for pesticides, and EPA conduct of intentional dosing human toxicity studies for pesticides.  This ICR applies to all of the information collection activities identified in the final rule EPA promulgated in response to the Congressional mandate.  EPA's statutory authority to require and collect information identified in the final rule already existed under FIFRA and FFDCA.

  Sections 3(c)(5), 3(g) and 4(g)(2)(D) of FIFRA generally require EPA to determine that a pesticide would not present any "unreasonable adverse effects on the environment" when deciding to grant a new or amended pesticide registration or to continue an existing registration.  Section 4(g)(2)(E) of FIFRA and section 408(b)(2)(A)(ii) of FFDCA generally require EPA to determine that that there is a reasonable certainty that no harm will result from aggregate exposure to the residue of a pesticide chemical, including all anticipated dietary exposures and all other exposures for which there is reliable information when making pesticide tolerance decisions.  FIFRA section 12(a)(2)(P) forbids any person "to use any pesticide in tests on human beings unless such human beings (i) are fully informed of the nature and purposes of the test and of any physical and mental health consequences which are reasonably foreseeable from, and (ii) freely volunteer to participate in the test."  EPA established this collection of information as part of the final rule as authorized under section 25 of FIFRA and section 408(e)(1)(C) of FFDCA to:

(1)	ensure that sound and appropriate scientific data are available to EPA when 			making regulatory decisions about pesticides as described in the previous 				paragraph; and,

      (2)	protect the interests, rights and safety of human research subjects, as required under FIFRA section 12(a)(2)(P).

Sections 3(c)(5), 3(g), 4(g)(2), and 25 of FIFRA, and sections 408(b)(2)(A)(ii) and 408(e)(1)(C) of FFDCA are included as Supporting Statement attachments B and C, respectively.

      2(b)	Practical Utility/Users of the Data

      In order to ensure the availability of sound and appropriate scientific data in its decisions, and to protect the interests, rights and safety of human research subjects, EPA extended the requirements of the Agency's Common Rule, 40 CFR Part 26, prospectively to third-party research intended for submission to EPA under the pesticide laws and involving intentional exposure of non-pregnant, non-nursing adult human subjects.  The information provided allows EPA to review protocols and related information before research involving human subjects is initiated, after it has been reviewed and approved by a local IRB.  In addition, anyone who submits to EPA a report of research with human subjects must submit concurrently documentation of the ethical conduct of the research.  This information collection activity allows EPA to ensure all human subjects in research conducted by EPA (first party), conducted by entities with support from EPA (second parties), or conducted by third parties with the intention to submit it to EPA are treated ethically.

3.		NON DUPLICATION, CONSULTATIONS, AND OTHER COLLECTION CRITERIA

      3(a)	Non duplication

		The information requirements identified in the final rule do not duplicate other federal agency information collections.  Other federal agencies have adopted the Common Rule and FDA has established requirements similar to those in the Common Rule for third-party researchers who perform human testing intended for submission to FDA.   None of those requirements, however, apply to third-party research that is intended for submission to EPA.

      3(b)	Public Notice Required Prior to ICR submission to OMB

       Pursuant to 5 CFR 1320.8(d), EPA is publishing a Federal Register (FR) notice soliciting comment on this information collection activity and the Agency's intent to renew the OMB approval of this ICR.  The FR notice and the proposed renewal ICR as well as any public comment are located in the docket for this action, which can be accessed at http://www.regulations.gov using the docket identifier EPA-HQ-OPP-2011-0704.

      3(c)	Consultations

      During preparation of this ICR renewal, EPA staff will contact respondent representatives to seek feedback on the burden estimates in the ICR and the clarity of guidance provided.  Their responses to EPA's consultation efforts will be summarized and made publicly available with the final ICR renewal request, as Attachment D.

      3(d)	Effects of Less Frequent Collection

	Not applicable.  This is an event-driven information collection activity and is conducted only as information is submitted to EPA for consideration.  As such there is no set collection frequency for the collection of this information.

      3(e)	General Guidelines

		The only guideline established under the Paperwork Reduction Act (PRA) that may be exceeded in this collection is the time period for retaining records.  EPA's requirement at 40 CFR 169.2(k) states that records containing research data relating to registered pesticides be retained for as long as the registration is valid and the producer remains in business.  Registrations are valid until they are either voluntarily canceled or withdrawn by the registrant or until EPA has cause to suspend or cancel the registration.

      Since the average period of marketability of a pesticide ranges from 15 to 30 years, the PRA guidelines specifying that data other than health, medical or tax records not be required to be retained for more than three years will be exceeded in this collection activity.  This is an existing requirement that was not changed by the final rule.  In any case, EPA asserts that recordkeeping requirement merely codifies the usual and customary business practices of IRBs and third-party researchers; therefore no burden is attributed to the activity.

      OMB regulations require agencies to provide a statement indicating whether the collection of information involves the use of automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses, and an explanation of the decision (5 CFR
1320.5(a)(iii)(E)).  EPA is not offering a fully electronic submission option at this time.  EPA is developing an internet portal that would adequately secure any confidential and/or sensitive information submitted electronically; however, EPA is not yet ready to accept such information in this way.

		Respondents that submit study protocols and/or reports to EPA may elect to submit certain information "electronically" via compact disc.  Ordinarily, registrants would be required to submit 3 paper copies of study data to EPA.  Under this hybrid option, registrants need only submit 2 paper copies if they submit the required study data in Adobe Acrobat Portable Document Format (PDF) on a compact disc.

      Once EPA staff have become familiar with the electronic submission process and the technology, OPP believes that this option will allow the Agency to achieve operating efficiencies in the regulation of pesticides through the promotion and facilitation of the electronic submission process, including the delivery, review, data interchange capability and archiving of data supporting national pesticide registration.  OPP expects that registrants will spend less time and money preparing copies and sending their submissions using the hybrid paper-electronic submission option, and stand to benefit from the efficiencies that EPA expects to experience during data reviews.

      3(f)		Confidentiality

		EPA has implemented procedures to protect any confidential, trade secret or proprietary information from disclosure that provide strict instructions regarding access to and contact with documents confidential business information (CBI).  These procedures comply with EPA's CBI regulations at 40 CFR Part 2, Subpart B.

      3(g)	Sensitive Questions

      This information collection activity complies with the provisions of the Privacy Act of 1974 and OMB Circular A-108.  No information of a sensitive or private nature is requested in conjunction with this information collection activity.  The protection of human research subjects' privacy is a basic, long-standing principle within the scientific community.  Reports of human research submitted to federal agencies should not identify subjects by name, or include recognizable photographs, or otherwise identify them.  On the rare occasion that the Agency receives identifying information, such information will be treated as confidential and not released to third parties unless required by law.

4. 		THE RESPONDENTS AND THE INFORMATION REQUESTED

      4(a)	Respondents/NAICS Codes

		This collection of information applies to any entity that submits protocols and study reports for environmental research involving human subjects under FIFRA and/or FFDCA. Although EPA has only received such third-party research in conjunction with FIFRA from pesticide registrants, it is conceivable that other entities could submit such information to EPA under FIFRA and/or FFDCA in the future.  The North American Industrial Classification System (NAICS) code for the principal respondents to this ICR is 541710 (Research and Development in the Physical, Engineering, Life Sciences).

		4(b)	Information Requested

 Data items, including record keeping requirements

 		The final rule sets forth those additional information activities that are necessary to ensure the protection of human subjects of research when such research is submitted to EPA for consideration under FIFRA and/or FFDCA.

 Respondent Activities

	The following information activities are required:

   * Rule Familiarization and Training - read, and understand what data are to be submitted and understand the protocols must be developed to comply with the Common Rule.

   * Submit Protocol to an IRB and EPA  -  Prepare and submit a proposal for test protocol to IRB for review.  After approval by the IRB, submit the proposal and related documentation, including a record of the IRB approval, to EPA.

   * Prepare and Submit Ethics Information for EPA Review - once a study is conducted, compile applicable records to document ethical conduct of the research.

   * Store, File and Maintain Information  -  ensure that research information is placed in central records as required by FIFRA and consistent with section 3(e) of this ICR.

5. 	THE INFORMATION COLLECTED - AGENCY ACTIVITIES, COLLECTION METHODOLOGY, AND INFORMATION MANAGEMENT

      5(a)	Agency Activities

		EPA's information-related activities associated with this collection consist of the following:

   * Conduct Prior review on study protocol  -  review and comment on study protocol, document comments/review.

   * Review Ethical Aspect of a Protocol and Study Report  -  make formal EPA determination on usefulness and ethical aspects of the study.

   * Record and Report Information  -  Document any formal decisions made.

   * Store, File and Maintain Information  -  compile information into appropriate databases and archive.

      5(b)	Collection Methodology and Management

	OPP completed a major review of its information tracking systems to improve their efficiency and accuracy. This review resulted in the development of a new integrated information system, which, when complete, will improve the quality of the Agency's databases and allows the EPA to respond more timely and accurately to queries from registrants and the public, including requests made under the FOIA.

	OPP is also investigating the possibility of providing optional electronic data transfer services to the industry as a means of minimizing the burden of registration activities. The Agency's pesticide program, along with the pesticide industry, recognizes the advantages in terms of accuracy, speed, cost and personnel from electronic data transfer technologies. In addition, OPP is consulting with industry associations and other federal agencies, and participating in an Agency-wide workgroup to develop electronic reporting standards intended to facilitate collection of information from industry.

		OPP does not publish the studies submitted.  However, it maintains records of each study in the Office of Pesticide Programs Information Network (OPPIN), and provides public access to OPPIN bibliographies through the National Pesticides Information Retrieval System (NPIRS). NPIRS supports searches of the PDMS database by chemical, subject, submission date, laboratory, guideline number, and document type, and the public may request copies of studies that are non-confidential by submitting a FOIA request.

      5(c)	Small Entity Flexibility

      Although the Agency cannot predict whether or how many small entities might engage in the subject matter research, the burden and related cost for researchers to comply with these information collection activities is estimated to be a comparatively small portion of the overall cost of performing such studies.  After reviewing the history of EPA's consideration on human research in its various program offices, EPA estimates that only a limited number of third-party human studies will be impacted by these activities each year.  Because both the number of affected studies is relatively small and the estimated current costs of compliance with the Common Rule are low, the potential overall burden and costs from these activities to third parties are also estimated to be small, regardless of their size.  As a result, EPA has not provided any special flexibility for small entities.

      5(d)	Collection Schedule

		A periodic collection schedule is not appropriate for the information collection activity.  The information collection activity is initiated by the respondents and therefore EPA expects that respondents will engage in the activities described in this ICR only once, whenever developing and performing a given research study that involves human subjects as governed by EPA's regulations.

6. 		ESTIMATING THE BURDEN AND COST OF THE COLLECTION

      6(a)	Estimating Respondent Burden

		EPA is estimating only the incremental burden imposed upon respondents for compliance with the paperwork requirements established in the final rule.  EPA is neither estimating, de novo, the estimated paperwork burden for compliance with the 1991 Common Rule in this ICR nor the paperwork burden associated with the generation of certain study data that is already covered by other ICRs, such as those requested by EPA in a Data Call-In under FIFRA section 3(c)(2)(B).  EPA does assume that IRBs are already in compliance with the 1991 Common Rule requirements and therefore believes that there is no additional burden imposed upon IRBs for compliance with the paperwork requirements established in the final rule and discussed in this document.

 	Based upon responses received in previous years to the Agency's consultation questions, as well as historical data, EPA anticipates that respondents will submit to OPP an average of 34 pesticide research studies per year under FIFRA and/or FFDCA that will involve intentional exposure of human subjects.  See Attachment E for an explanation of the methodology, data, and assumptions used to calculate and revise previous estimates of respondent burdens and costs.

      EPA also expects to receive other types of pesticide research involving human subjects; an average of 20 studies annually.  While EPA assumes that researchers conducting these studies would already be required to comply with the 1991 Common Rule requirements, they will be subject to some additional paperwork requirements under EPA's amendments.  Therefore, EPA is estimating only the burden and costs associated with the paperwork activities that are described in the final rule.

		Respondent activities that are within the scope of this ICR include: preparing and submitting protocols, supporting documents, and completed study reports for IRB, EPA, and HSRB review; communicating with IRB and EPA staff regarding required changes to a protocol; communicating with EPA about HSRB recommendations; and documenting protocol changes made at the recommendation of an IRB, EPA, or the HSRB.  Activities which are unrelated to the paperwork and recordkeeping requirements of the final rule, such as the costs of conducting the research, are not incremental paperwork or recordkeeping costs and therefore are not within the scope of this ICR.

 	The consultation responses indicated that EPA's previous estimates significantly underestimated the actual burden and costs.  Thus, to calculate new burden and cost estimates for this renewal ICR, EPA relied upon the figures provided in the five consultation responses.  Two of the five participants in the consultation process were also the two parties that submitted comments during the public comment period; the input they provided in their public comments was essentially the same as that included in the consultation responses.  EPA calculated a weighted average of the estimates contained in each of the responses, to account for the fact that some study types are more complex than others.

      As shown in Tables 1 and 2, the total annual estimated burden associated with this information collection activity is 20,332 hours for all submitted pesticide research that involves intentional exposure of human subjects, and 240 hours for all other pesticide research that involves human subjects.  Therefore the total annual burden for this information collection activity is estimated to be 20,572 hours.

 Table 1.	Respondent Burden and Cost Estimates  -  Research Involving Intentional Exposure of Human Subjects

                                  Activities
                       Average Burden Hours Per Response
                              Total Per Response

                                  Management
                                   Technical
                                   Clerical
                                     Hours
                                   Cost ($)

                                    $152.89
                                    $78.54
                                    $45.43

Rule familiarization and training
                                       2
                                       4
                                       2
                                       8
                                      711
Prepare and submit protocol for IRB review
                                      31
                                      83
                                      33
                                      147
                                    12,758
Prepare and submit protocol for EPA and HSRB review
                                      25
                                      181
                                      37
                                      243
                                    19,719
Document ethical conduct of a completed study for which EPA and the HSRB have reviewed the protocol
                                      19
                                      113
                                      21
                                      153
                                    12,734
Document ethical conduct of a pre-rule study for which EPA and the HSRB have not reviewed the protocol
                                       5
                                      16
                                       8
                                      29
                                     2,385
Store, file, maintain records
                                       4
                                       8
                                       6
                                      18
                                     1,512
Total per response
                                      86
                                      405
                                      107
                                      598
                                    49,818

Annual Burden: 	598 hours per protocol or completed study * 34 protocols or completed studies per year = 20,332 hours
Annual Costs:	$49,818 per study * 34 protocols or completed studies per year = $1,693,821

Table 2.	Respondent Burden and Cost Estimates  -  All Other Submitted Research with Human Subjects

                                  Activities
                       Average Burden Hours Per Response
                              Total Per Response

                                  Management
                                   Technical
                                   Clerical
                                     Hours
                                   Cost ($)

                                    $152.89
                                    $78.54
                                    $45.43

Rule familiarization and training
                                       1
                                       1
                                       0
                                       2
                                      231
Prepare and Submit Ethics Information of Completed Human Studies to EPA
                                       0
                                       8
                                       1
                                       9
                                      674
Store, file, and maintain records
                                       0
                                       0
                                       1
                                       1
                                      45
Total per response
                                       1
                                       9
                                       2
                                      12
                                      951

Annual Burden:	12 hours per study * 20 studies submitted per year = 240 hours
Annual Costs:		$951 per study * 20 studies submitted per year = $19,012

      6(b)	Estimating Respondent Costs

      The estimated annual cost for all respondents is $1,712,833.  Respondent labor rates are estimated to be $153, $79, and $45 per hour, respectively, for managerial, technical and clerical labor.  These labor rates were derived from the Bureau of Labor Statistics' May 2010 National Industry-Specific Occupational Employment and Wage Estimates for NAICS code 541710 (Research and Development in the Physical, Engineering, and Life Sciences).  These labor rates are fully loaded and include benefits and overhead costs, using a methodology developed by OPP's Biological and Economic Analysis Division (see Attachment F).

      6(c)	Estimating Agency Burden and Cost

      The total estimated Agency annual cost is $644,038 (see Table 5).  EPA activities include: communicating with respondents, reviewing the ethical aspects of submitted study protocols and completed study reports, making presentations to the HSRB, documenting decisions, and information management activities to record, file, and track the submissions.

      Agency labor rates are $120, $72, and $43 per hour for management, technical, and clerical staff, respectively.  These labor rates were derived from the Bureau of Labor Statistics' May 2010 National Industry-Specific Occupational Employment and Wage Estimates for NAICS code 999100 (Federal Executive Branch).  These labor rates are fully loaded and include benefits and overhead costs, using a methodology developed by OPP's Biological and Economic Analysis Division (see Attachment G).  The details of the calculations are identified in Tables 3 and 4.

Table 3.	Agency Burden & Cost Estimates  -  Review of Research Involving Intentional Exposure of Human Subjects

                                  Activities
                       Average Burden Hours Per Response
                              Total Per Response

                                  Management
                                   Technical
                                   Clerical
                                     Hours
                                   Cost ($)

                                     $120
                                      $72
                                      $43

Rule familiarization and training
                                       2
                                       2
                                       0
                                       4
                                      383
Primary Review of Scientific and Ethical Aspects of a Protocol
                                       1
                                      113
                                       0
                                      114
                                     8,208
Primary Review of Ethical Aspects of a Completed Study Report
                                       1
                                      57
                                       0
                                      58
                                     4,200
Secondary Review of Scientific and Ethical Aspects of a Protocol or Review of Ethical Aspects of a Completed Study
                                    4,172*
Store, file, and maintain records
                                       0
                                       0
                                       2
                                       2
                                      86
                            Total per protocol or
                                completed study
                                       4
                                      172
                                       2
                                      178
                                    17,050

      1. * The value 4,172 is computed in line 7) below.
      2. Cost of HSRB members working on the HSRB report (collectively spending 240 hours per HSRB report in FY 2008, compensated at the rate of $53/hour, plus the cost of EPA Office of the Science Advisor technical staff working on the HSRB report (171 hours per report, at the technical staff rate of $72/hour).  Each HSRB report covers an average of 6 protocols and/or completed studies per report.
      3. 240 hours/HSRB Members/report * $53/hour = $12,720/report
      4. 172 hours/OSA Staff/report*$72/hour = $12,312/report
      5. Total Cost for HSRB Member and OSA Staff Review Time Per Report = $12,720 + $12,312 = $25,032
      6. If 1 report = 6 protocols
      7. Total Cost for HSRB Member and OSA Staff Review Time Per Protocol = $25,032/6 = $4,172/protocol

Annual Burden:  	178 hours per study or protocol * 34 protocols or completed studies = 6,052 hours
Annual Costs:		17,050 * 34 protocols or completed studies = $579,684

Table 4. Agency Burden & Cost Estimates  -  Review of All Other Submitted Research with Human Subjects

                                  Activities
                        Average Burden Hours Per Study
                                Total Per Study

                                  Management
                                   Technical
                                   Clerical
                                     Hours
                                   Cost ($)

                                     $120
                                      $72
                                      $43

Rule Familiarization And Training
                                       1
                                       1
                                       0
                                       2
                                      191
Primary Review Ethical Aspects of a Completed Study Report
                                       1
                                      40
                                       0
                                      41
                                     2,983
Store, File and Maintain Information
                                       0
                                       0
                                       1
                                       1
                                      43
Total per study
                                       2
                                      41
                                       1
                                      44
                                     3,218

	Annual Burden:	44 hours/study * 20 studies = 880 hours
	Annual Costs:		$3,218/study * 20 studies = $64,354

      6(d)	Bottom Line Burden Hours and Cost Tables

		The total estimate represents the information collection activities expected to occur annually over the next three years.  Table 5 provides the total estimated annual burden and costs for respondents, as well as the total estimated annual burden and costs for the Agency:

Table 5.  Total Annual Bottom Line Burden and Costs / Master Table

                              Collection Activity
                              Annual Burden Hours
                                 Annual Costs
                      Annual Respondent Burden and Costs

      Research Involving Intentional Exposure of Human Subjects (Table 1)
                                    20,332
                                  $1,693,821
          All Other Submitted Research with Human Subjects (Table 2)
                                      240
                                    $19,012
                               Respondent Total
                                    20,572
                                   1,712,833
                             Annual Agency Burden

      Research Involving Intentional Exposure of Human Subjects (Table 3)
                                     6,052
                                   $579,684
          All Other Submitted Research with Human Subjects (Table 4)
                                      880
                                    $64,354
                                 Agency Total
                                     6,932
                                    644,038

      6(e)	Reasons for Change in Burden

		There is no change in the labor hours in this ICR as compared to the previous ICR.  There is, however, an increase in the estimated burden cost as currently identified in the OMB Inventory of Approved ICR Burdens. This is not due to any program changes. The change in burden cost is due to the use of the most updated labor rates.  The estimates for this renewal ICR are based on the labor hours of operating the HSRB that was approved by OMB during Fiscal Year 2008.

      6(f)		Burden Statement

      The total estimated annual paperwork burden to comply with this information collection activity is 20,572 hours.  The average burden is estimated to be 598 hours per response for research involving intentional exposure of human subjects, and 12 hours per response for all other submitted research with human subjects.

      According to the Paperwork Reduction Act, "burden" means the total time, effort, or financial resources expended by persons to generate, maintain, retain, disclose, or provide information to or for a Federal agency.  The agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.  The OMB control number for this information collection appears at the beginning and end of this document. In addition OMB control numbers for EPA's regulations, after initial display in the final rule, are listed in 40 CFR Part 9 (see Attachment H).

      The Agency has established a public docket for this ICR under Docket ID No. EPA-HQ-OPP-2011-0704, which is available for online viewing at www.regulations.gov, or in person viewing at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Building), 2777 S. Crystal Drive, Arlington, VA.  This docket facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays.  The docket telephone number is<PHONE_NUMBER>.  You may submit comments regarding the Agency's need for this information, the accuracy of the provided burden estimates and any suggested methods for minimizing respondent burden, including the use of automated collection techniques.

      Submit your comments, referencing Docket ID No. EPA-HQ-OPP-2011-0704 and OMB Control No. 2070-0169, to (1) EPA online using www.regulations.gov (our preferred method), or by mail to: Public Information and Records Integrity Branch (PIRIB), Mail Code: 7502P, Office of Pesticide Programs (OPP), Environmental Protection Agency, 1200 Pennsylvania Ave., NW, Washington, DC 20460, and (2) OMB by mail to: Office of Information and Regulatory Affairs, Office of Management and Budget (OMB), Attention: Desk Officer for EPA, 725 17th Street, NW, Washington, DC 20503.
                   ATTACHMENTS TO THE SUPPORTING STATEMENT:

Attachments to the supporting statement are available in the public docket established for this ICR under docket identification number EPA-HQ-OPP-2011-0704.  These attachments are available for online viewing at www.regulations.gov or otherwise accessed as described in section 6(f) of the supporting statement.

Attachment A:	Final Rule; Protections for Test Subjects in Human Research

Attachment B:	FIFRA Sections 3(c)(5), 3(g), 4(g)(2), and 25

Attachment C:	FFDCA Sections 408(b)(2)(A)(ii) and 408(e)(1)(C)

Attachment D:	(Reserved) Record of EPA Consultations With Respondents

Attachment E:	Memorandum on Calculation of Burden and Cost

Attachment F:	Wage Rate Tables for Pesticide Registrants

Attachment G:	Work Sheet used to Calculate EPA Labor Costs

Attachment H:	Display Related to OMB Control #2070-0169 -Listings of Related Regulations in 40 CFR 9.


[Federal Register Volume 83, Number 161 (Monday, August 20, 2018)]
[Notices]
[Page 42115]
[FR Doc No: 2018-17861]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #1

    Take notice that the Commission received the following electric
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11/2018.
    Filed Date: 8/10/18.
    Accession Number: 20180810-5167.
    Comments Due: 5 p.m. ET 8/31/18.

    Docket Numbers: ER18-2202-000.
    Applicants: Vermont Transco LLC.
    Description: Request for Rate Recovery of Vermont Transco LLC.
    Filed Date: 8/10/18.
    Accession Number: 20180810-5180.
    Comments Due: 5 p.m. ET 8/31/18.

    Docket Numbers: ER18-2203-000.
    Applicants: Upper Michigan Energy Resources Corporation.
    Description: Baseline eTariff Filing: UMERC Filing of Market-Based
Rate Tariff to be effective 10/12/2018.
    Filed Date: 8/13/18.
    Accession Number: 20180813-5050.
    Comments Due: 5 p.m. ET 9/4/18.

    Docket Numbers: ER18-2204-000.
    Applicants: ISO New England Inc.
    Description: ISO New England Inc. submits Second Quarter 2018
Capital Budget Report.
    Filed Date: 8/10/18.
    Accession Number: 20180810-5194.
    Comments Due: 5 p.m. ET 8/31/18.

    Docket Numbers: ER18-2205-000.
    Applicants: Nevada Power Company.
    Description: Sec.  205(d) Rate Filing: Rate Schedule No. 136 NPC/
APS Mead-Phoenix Project Concurrence to be effective 7/1/2018.
    Filed Date: 8/13/18.
    Accession Number: 20180813-5118.
    Comments Due: 5 p.m. ET 9/4/18.

    Docket Numbers: ER18-2206-000.
    Applicants: GridLiance West LLC.
    Description: Sec.  205(d) Rate Filing: GridLiance West Name Change
Filing to be effective 8/13/2018.
    Filed Date: 8/13/18.
    Accession Number: 20180813-5129.
    Comments Due: 5 p.m. ET 9/4/18.

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

    Dated: August 13, 2018.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2018-17861 Filed 8-17-18; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register: February 15, 2008 (Volume 73, Number 32)]
[Rules and Regulations]
[Page 8796-8798]
[DOCID:fr15fe08-6]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 135

[Docket No. FAA-1999-6717; Amendment No. 135-112]
RIN 2120-AI03

Extended Operations (ETOPS) of Multi Engine Airplanes

AGENCY: Federal Aviation Administration, DOT.

ACTION: Final rule; delay of compliance dates.

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

SUMMARY: The Federal Aviation Administration (FAA) is delaying the
compliance date for certain sections of a final rule, published January
16, 2007, that established regulations governing the design, operation,
and maintenance of certain airplanes operated on flights that fly over
180 minutes from an adequate airport. The extension of the compliance
date is necessary to give operators additional time to gain a
comprehensive understanding of Extended Operations (ETOPS)
requirements, develop training and procedures, and implement safety
measures established in the final rule. In addition, the regulatory
text for certain sections is amended to reflect this delay of
compliance dates.

DATES: Effective Dates: The effective date for the amendments in this
final rule is February 15, 2008.
    Compliance Dates: The compliance date contained in the Final Rule
(72 FR 1808), for Sec. Sec.  135.98, 135.345(a)(9), and 135.364,
section G135.2.1 of appendix G to part 135, and section G135.2.9 of
appendix G to part 135 is delayed by 180 days, from February 16, 2008,
to August 13, 2008. The delay of compliance dates for these specific
sections of the Final Rule does not affect any other compliance date
established in Table 2 of Section VI of the preamble to the Final Rule.

FOR FURTHER INFORMATION CONTACT: Jim Ryan, Air Carrier Operations
Branch (AFS-220), Air Transportation Division, Flight Standards
Service, Federal Aviation Administration, 800 Independence Ave., SW.,
Washington, DC 20591, Telephone<PHONE_NUMBER>), E-Mail
<EMAIL_ADDRESS>

SUPPLEMENTARY INFORMATION:

Availability of Rulemaking Documents

    You can get an electronic copy of rulemaking documents using the
Internet by--
    1. Searching the Federal eRulemaking Portal (http://www.regulations.gov
);

    2. Visiting the FAA's Regulations and Policies Web page at http://www.faa.gov/regulations_policies/
; or

    3. Accessing the Government Printing Office's Web page at http://www.gpoaccess.gov/fr/index.html
.

    You can also get a copy by sending a request to the Federal
Aviation Administration, Office of Rulemaking, ARM-1, 800 Independence
Avenue, SW., Washington, DC 20591, or by calling<PHONE_NUMBER>. Make
sure to identify the amendment number or docket number of this
rulemaking. Anyone is able to search the electronic form of all
comments received into any of our dockets by the name of the individual
submitting the comment (or signing the comment, if submitted on behalf
of an association, business, labor union, etc.). You may review DOT's
complete Privacy Act statement in the Federal Register published on
April 11, 2000 (Volume 65, Number 70; Pages 19477-78), or you may visit
http://DocketInfo.dot.gov.

Small Business Regulatory Enforcement Fairness Act

    The Small Business Regulatory Enforcement Fairness Act (SBREFA) of
1996 requires FAA to comply with small entity requests for information
or advice about compliance with statutes and regulations within its
jurisdiction. If you are a small entity and you have a question
regarding this document, you may contact your local FAA official, or
the person listed under FOR FURTHER INFORMATION CONTACT. You can find
out more about SBREFA on the Internet at http://www.faa.gov/

regulations--policies/rulemaking/ sbre--act/.

Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. Subtitle I, Section 106
describes the authority of the FAA Administrator. Subtitle VII,
Aviation Programs, describes in more detail the scope of the agency's
authority. This rulemaking is promulgated under the authority described
in Subtitle VII, Part A, subpart I, 49 U.S.C. 44701. Under that
section, the FAA is charged with regulating air commerce in a way that
best promotes safety.

Background

    The Extended Operations of Multi Engine Airplanes (ETOPS) Final
Rule (72 FR 1808) established regulations governing the design,
operation, and maintenance of certain airplanes operated on flights
that fly long distances from an adequate airport. The final rule
affected aircraft operators under 14 CFR parts 121 and 135, as well as
manufacturers under 14 CFR parts 21, 25, and 33. The Final Rule,
published January 16, 2007, establishes a compliance schedule for
affected operators and manufacturers that was designed to ease the
burden of compliance and make the rule less costly. The FAA established
a compliance date of 1 year for part 135 operators to meet the
operational and training requirements of the final rule. For cargo fire
suppression, the final rule allows 8 years for currently approved part
135 ETOPS operators to comply. In that final rule, the FAA published
commenters' observations that ``There is no FAA guidance for, and FAA
Inspectors have not approved, any part 135 ETOPS flights'' (72 FR
1849).
    Previous FAA guidance has addressed ETOPS operations for 121
operators. In December 1998, the FAA published Advisory Circular (AC)
120-42A, Extended Range Operation with Two-Engine Airplanes. This AC
contained guidance for operators under part 121 who wished to engage in
ETOPS operations. Based on this guidance, part 121 operators have been
conducting safe and successful ETOPS flights for over 20 years. Until
the final rule was published on January 16, 2007, part 135 operators
did not need FAA approval for ETOPS flights. Because the final rule
establishes new requirements for part 135 operations, the FAA intends
to support successful implementation of the operational and training
requirements in the final rule for part 135 operations by publishing an
AC that addresses the requirements for part 135 operators. On September
17, 2007, the FAA published and invited comment on two draft ACs, draft
AC 120-42B for part 121 operators and draft AC 135-42 for part 135
operators (FAA-2002-6717, http://dms.dot.gov).

    The FAA has determined that the current guidance available for part
121 operators regarding ETOPS flights is sufficient for part 121
operators to meet the compliance schedule in the final rule. However,
because the ETOPS requirements in the final rule are new for part 135
operators, the FAA has determined that it is appropriate to delay
compliance for certain part 135 operational and training requirements
(i.e. Sec. Sec.  135.98, 135.345(a)(9), 135.364, section G135.2.1 of
appendix G to part 135, and section G135.2.9 of appendix G to part 135)
until after the guidance in AC 135-42 is published. The delay of the
compliance date is necessary to give part 135 operators additional time
to gain a comprehensive understanding of ETOPS requirements, develop
training and procedures, and implement the safety measures established
in the Final Rule.

Good Cause for Foregoing Public Notice and Comment

    Section 553(b)(3)(B) of the Administrative Procedure Act, 5 U.S.C.
553(b)(3)(B), authorizes agencies to dispense with certain notice
procedures for rules when they find ``good cause'' to do so. Under
section 553(b)(3)(B), the requirements of notice and opportunity for
comment do not apply when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.''
    In this case, the FAA finds that notice and public comment are
unnecessary and contrary to the public interest. This action delays the
compliance date for several sections of the final rule published
January 16, 2007. We issued those regulations using the public notice
and comment procedure. In that final rule, we published commenters'
observations that ``There is no FAA guidance for, and FAA inspectors
have not approved, any part 135 ETOPS flights'' (72 FR 1849). The FAA
intends to support successful implementation of the operational and
training requirements in the final rule for part 135 operations by
publishing an Advisory Circular that addresses these requirements. On
September 17, 2007, the FAA published and invited comment on draft AC
135-42 for part 135 operators (FAA-1999-6717, http://www.regulations.gov
).

    The FAA has determined that it is contrary to the public interest
to require part 135 operators to comply with the requirements of the
final rule until AC 135-42 is published. The FAA has determined that
notice and public comment are unnecessary because the public has
already commented that FAA guidance is necessary for part 135
operators. The public is best served by delaying the compliance date
for the part 135 operational and training requirements in the rule to
allow time for publication of the AC, which will provide part 135
operators with a comprehensive understanding of ETOPS requirements.

Good Cause for Immediate Adoption

    Since the delay in the compliance date of the final rule does not
impose any new requirements or any additional burden on the regulated
public, the FAA finds that good cause exists for immediate adoption of
the compliance date without a 30-day notice period.

The Effect of Our Decision

    Our decision delays the compliance date of certain sections of the
final rule (72 FR 1809, January 15, 2007), Sec. Sec.  135.98,
135.345(a)(9), and 135.364, section G135.2.1 of appendix G to part 135,
and section G135.2.9 of appendix G to part 135, from February 16, 2008,
to August 13, 2008.

List of Subjects in 14 CFR Part 135

    Air taxis, Aircraft, Airmen, Alcohol abuse, Aviation safety, Drug
abuse, Drug testing, Reporting and recordkeeping requirements.

The Amendment

0
In consideration of the foregoing, the Federal Aviation Administration
amends Chapter I of Title 14, Code of Federal Regulations as follows:

PART 135--OPERATING REQUIREMENTS; COMMUTER AND ON DEMAND OPERATION
AND RULES GOVERNING PERSONS ON BOARD SUCH AIRCRAFT

0
1. The authority citation for part 135 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 41706, 44113, 44701-44702, 44705,
44709, 44711-44713, 44715-44717, 44722.

0
2. Amend Sec.  135.98 by revising the introductory text to read as
follows:

Sec.  135.98  Operations in the North Polar Area.

    After August 13, 2008, no certificate holder may operate an
aircraft in the region north of 78[deg] N latitude (``North Polar
Area''), other than intrastate operations wholly within the state of
Alaska, unless authorized by the FAA. The certificate holder's
operation specifications must include the following:
* * * * *

0
3. Amend Sec.  135.345 by revising paragraph (a)(9) to read as follows:

Sec.  135.345  Pilots: Initial, transition, and upgrade ground
training.

* * * * *
    (a) * * *
    (9) After August 13, 2008, passenger recovery plan for any
passenger-carrying operation (other than intrastate operations wholly
within the state of Alaska) in the North Polar area; and
* * * * *

0
4. Revise Sec.  135.364 to read as follows:

Sec.  135.364  Maximum flying time outside the United States.

    After August 13, 2008, no certificate holder may operate an
airplane, other than an all-cargo airplane with more than two engines,
on a planned route that exceeds 180 minutes flying time (at the one-
engine-inoperative cruise speed under standard conditions in still air)
from an Adequate Airport outside the continental United States unless
the operation is approved by the FAA in accordance with Appendix G of
this part, Extended Operations (ETOPS).

0
5. Revise the introductory text of section G135.2.1, and section
G135.2.9, of appendix G to part 135 to read as follows:

Appendix G to Part 135--Extended Operations (ETOPS)

* * * * *
    G135.2 Requirements.
    G135.2.1 General. After August 13, 2008, no certificate holder
may operate an airplane, other than an all-cargo airplane with more
than two engines, outside the continental United States more than
180 minutes flying time (at the one-engine-inoperative cruise speed
under standard conditions in still air) from an airport described in
Sec.  135.364 unless--
* * * * *
    G135.2.9 Delayed compliance date for all airplanes. A
certificate holder need not comply with this appendix for any
airplane until August 13, 2008.

    Issued in Washington, DC, on February 11, 2008.
 Rebecca Byers MacPherson,
Assistant Chief Counsel for Regulations.
 [FR Doc. E8-2879 Filed 2-14-08; 8:45 am]

BILLING CODE 4910-13-P