[Federal Register: December 15, 2005 (Volume 70, Number 240)]
[Notices]
[Page 74310-74311]
[DOCID:fr15de05-58]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket Nos. ER05-1325-002, ER05-1319-002, ER05-1324-002]

Pacific Gas and Electric Company; Notice of Filing

December 7, 2005.
    Take notice that on November 25, 2005, Pacific Gas and Electric
Company (PG&E) tendered for filing its Wholesale Distribution Tariff
Small Generator Interconnection Procedures and Small Generator
Interconnection Agreement in compliance with Commission Order issued on
October 11, 2005, 112 FERC ] 61,021.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as

appropriate. Such notices, motions, or protests must be filed on or
before the comment date. Anyone filing a motion to intervene or protest
must serve a copy of that document on the Applicant and all the parties
in this proceeding.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov.
 Persons unable to file electronically should submit an

original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the

``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For

TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. eastern time on December 16, 2005.

Magalie R. Salas,
Secretary.
[FR Doc. E5-7353 Filed 12-14-05; 8:45 am]

BILLING CODE 6717-01-P


December 14, 2021
MEMORANDUM
TO:		Air Docket EPA-HQ-OAR-2021-0845
SUBJECT: 	Lifecycle Greenhouse Gas Estimates for Renewable Diesel, Jet Fuel, Naphtha, LPG and Heating Oil Produced from Canola Oil via a Hydrotreating Process
This memorandum describes seven workbooks that contain our lifecycle greenhouse gas (GHG) estimates for biofuels produced from hydrotreated canola oil. The modeling approach and basis for the assumptions and analysis contained in these spreadsheets are described in the preamble for the proposed rule titled, "Renewable Fuel Standard Program: Canola Oil Pathways to Renewable Diesel, Jet Fuel, Naphtha, Liquefied Petroleum Gas and Heating Oil."
Description of workbooks docketed with this memo:
 Hydrotreated Canola Oil Biofuel Lifecycle GHG Estimates -- Contains Information Claimed CBI
      Description: This workbook contains lifecycle GHG estimates for biofuels produced from hydrotreated canola oil. This version of the workbook includes hydrotreating process data that is claimed as confidential business information (CBI).
 Hydrotreated Canola Oil Biofuel Lifecycle GHG Estimates -- Does Not Contain Information Claimed CBI
      Description: This workbook contains lifecycle GHG estimates for biofuels produced from hydrotreated canola oil. The original version of this workbook includes hydrotreating process data that is claimed as confidential business information (CBI). Information claimed CBI has been removed in this version.
 Hydrotreated Canola Oil Biofuel GHG Impact Estimates
      Description: This workbook contains lifecycle GHG estimates for canola oil feedstock used to produce biofuels through a hydrotreating process.
 Biofuel Life-cycle Emissions Stochastic Model (BSLAM)
      Description: This workbook performs a stochastic analysis of non-U.S. land conversions and associated land use change GHG emissions based on information about the uncertainty associated with uncertainty in the two main inputs: 1) categorization of historical land conversions based on satellite data and 2) land conversion emissions factors. It estimates the mean and 95% confidence interval estimates for land use change GHG emissions. It also reports dynamic land use change emissions over thirty years.
 Hydrotreated Canola Oil Biofuel International Fertilizer and Pesticide GHG Emissions
      Description: This workbook calculates total changes in fertilizer and pesticide use and associated GHG emissions based on crop area and production changes from the FAPRI-CARD model.
 Hydrotreated Canola Oil Biofuel International Crop Energy Inputs and Associated GHG Emissions
      Description: This workbook estimates GHG emissions from changes in crop energy inputs associated with producing biofuels from hydrotreated canola oil.
 Hydrotreated Canola Oil Biofuel FAPRI Results for Lifecycle GHG Analysis
      Description: This workbook contains results from the FAPRI-CARD model for two cases with different levels of canola oil production. The workbook uses these results to calculate crop and pasture area changes and livestock changes between these two scenarios.
Relationship between workbooks
Workbook #
Inputs from other workbooks
Outputs
1 and 2
Domestic and international agricultural emissions per pound of canola oil from #3; International land use change emissions from #4
Lifecycle GHG emissions (gCO2e/MJ of biofuel from hydrotreated canola oil)
3
Domestic agricultural sector results from the FASOMGHG model; International GHG estimates from #5 and #6
Agricultural sector GHG emissions per pound of canola oil (gCO2e/lb of canola oil)
4
International crop and pasture area changes from #7
International land use change GHG emissions per pound of canola oil (gCO2e/lb of canola oil)
5
International crop area and production changes from #7
Changes in fertilizer and pesticide application and associated nitrous oxide emissions per pound of canola oil
6
International crop area and changes from #7
GHG emissions associated with changes in crop energy inputs per pound of canola oil (gCO2e/lb of canola oil)
7
Inputs are results from the FAPRI-CARD model
Changes in crop production and area, pasture area in Brazil, and livestock production per pound of canola oil


[Federal Register Volume 77, Number 244 (Wednesday, December 19, 2012)]
[Notices]
[Pages 75174-75176]
[FR Doc No: 2012-30510]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-D-1168]

Draft Guidance for Industry on Providing Submissions in
Electronic Format--Summary Level Clinical Site Data for Center for Drug
Evaluation and Research's Inspection Planning; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance for industry entitled ``Providing
Submissions in Electronic Format--Summary Level Clinical Site Data for
CDER's Inspection Planning.'' The draft guidance is intended to assist
applicants in the voluntary submission of a clinical dataset that
describes and summarizes the characteristics and outcomes of clinical
investigations at the level of the individual study site (summary level
clinical site dataset). The summary level clinical site dataset is
intended to facilitate use of a risk-based approach to timely
identification of clinical investigator sites for onsite inspection by
FDA during the review of marketing applications. This draft guidance
describes a recommended electronic format for the summary level
clinical site dataset to be submitted voluntarily in new drug
applications (NDAs), biologics licensing applications (BLAs), and NDA
and BLA supplemental applications submitted to FDA's Center for Drug
Evaluation and Research (CDER).

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by February 19, 2013.

ADDRESSES: 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, 10903 New
Hampshire Ave., Bldg. 51, rm. 2201, 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.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Paul Okwesili, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 5353, Silver Spring, MD 20993-0002, 301-
796-0173.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Providing Submissions in Electronic Format--Summary Level
Clinical Site Data for CDER's Inspection Planning.'' FDA is responsible
for making regulatory decisions about drugs and

biological products after reviewing clinical safety and efficacy data
submitted in support of NDAs, BLAs, and NDA and BLA supplements
submitted to CDER (BLAs submitted to and reviewed by CDER as described
in the Federal Register of June 26, 2003 (68 FR 38067), available at
http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CBER/UCM186799.pdf). CDER's
Bioresearch Monitoring Program has specific responsibility for
verifying the integrity of data submitted to FDA in support of new NDAs
and BLAs and supplements, and for determining whether clinical trials
are conducted in compliance with applicable FDA regulations and
statutory requirements, including those intended to ensure the rights
and welfare of human research subjects.

A. Site Inspections

    As part of the application review process, FDA may conduct onsite
inspections of clinical investigators, sponsors, contract research
organizations, and institutional review boards. The study-related
information in applications is critical to FDA's selection of clinical
investigator sites for inspection. However, the current submission
format for the data does not facilitate efficient site selection. Thus,
CDER is requesting submission of a structured, summary-level clinical
site dataset.

B. Summary Level Clinical Site Dataset

    CDER recently initiated a pilot program evaluating a risk-based
model for selecting clinical investigators for inspection. This model
permits evaluation of an array of risk parameters across clinical
investigator sites associated with marketing applications.
    The summary level clinical site dataset:
     Contains data from all relevant studies used to support
evaluation of the application, including studies supportive of various
treatment indications; and
     Presents the characteristics and outcomes of the study at
the site level.
The data requested in the summary level clinical site dataset comprise
data elements currently collected under regulations in 21 CFR part 312
and maintained, tabulated, and submitted under regulations in 21 CFR
part 314, specifically Sec.  314.50(d)(5) Clinical data section and
Sec.  314.50(f) Case report forms and tabulations or in 21 CFR part
601, specifically Sec.  601.2 Applications for biologic licenses;
procedures for filing.
    The electronic submission of a summary level clinical site dataset
is intended to facilitate FDA's timely selection of clinical
investigator sites for inspection to evaluate the integrity of the data
submitted in the application or supplement.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the Agency's current thinking on this topic.
It does not create or confer any rights for or on any person and does
not operate to bind FDA or the public. An alternative approach may be
used if such approach satisfies the requirements of the applicable
statutes and regulations.

II. Comments

    Interested persons may submit either written comments regarding
this document to the Division of Dockets Management (see ADDRESSES) or
electronic comments regarding to http://www.regulations.gov. It is only
necessary to send one set of comments. Identify comments with the
docket number found in brackets in the heading of this document.
Received comments may be seen in the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to
the docket at http://www.regulations.gov.

III. Paperwork Reduction Act of 1995

    Under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C.
3501-3520), Federal Agencies must obtain approval from the Office of
Management and Budget (OMB) for each collection of information that
they conduct or sponsor. ``Collection of information'' is defined in 44
U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or
requirements that members of the public submit reports, keep records,
or provide information to a third party. Section 3506(c)(2)(A) of the
PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a
60-day notice in the Federal Register for each proposed collection of
information before submitting the collection to OMB for approval. To
comply with this requirement, FDA is publishing this notice of the
proposed collection of information set forth in this document.
    With respect to the collection of information associated with this
draft guidance, FDA invites comments on the following topics: (1)
Whether the proposed information collected is necessary for the proper
performance of FDA's functions, including whether the information will
have practical utility; (2) the accuracy of FDA's estimated burden of
the proposed information collected, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information collected; and (4) ways to
minimize the burden of information collected on the respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
    The draft guidance recommends an electronic format for a summary
level clinical site dataset to be submitted voluntarily in NDAs, BLAs,
and NDA and BLA supplemental applications submitted to CDER. The
summary level clinical site dataset is intended to facilitate use of a
risk-based approach to timely identification of clinical investigator
sites for on-site inspection by FDA during the review of marketing
applications.
    The summary level dataset comprises information required in parts
312, 314, or 601, including case histories (Sec.  312.62(b)),
information regarding foreign clinical studies not conducted under an
investigational new drug application (IND) (Sec.  312.120), and the
clinical data section (Sec.  314.50(d)(5)) and case report forms and
tabulations (Sec.  314.50(f)), or in part 601 (Sec.  601.2 Applications
for biologic licenses; procedures for filing) in an NDA, BLA, or
supplement. The draft guidance recommends that the data be submitted
electronically in a format that will facilitate site selection. The
variables described in the format are elements currently used in other
submissions; some of the variable names are new. The financial
disclosure information is currently reported in Module 1 (region
specific information) of the electronic common technical document, but
is new as a variable in a dataset. In addition, identifying that a
study has been conducted under an IND is new as a request in a dataset.
Initial preparation of the summary level clinical site dataset and the
development of new standard operating procedures (SOPs) would require
additional time. Once SOPs have been established, generation of the
dataset should not involve significant additional work. The applicant
would likely perform additional quality assurance, which may add time
to preparation and review of the submission.
    Based on CDER's data on the number of applications, including
supplements, that would be covered by the draft guidance, we estimate
that each year approximately 75 applicants will voluntarily submit for
96 applications the summary level clinical site dataset in electronic
format as recommended by

the draft guidance. We estimate that the submission of each summary
level clinical site dataset will take approximately 26 hours to
prepare.
    Initial preparation of the summary level clinical site dataset
would involve the development of new SOPs for the preparation of the
summary level clinical site dataset. We estimate that 75 applicants
would take approximately 12 hours to develop and subsequently 1 hour
annually to maintain and update the SOP(s). The summary level clinical
site dataset submitted with each application would likely involve
additional quality assurance procedures, which would add approximately
1 hour for each submission.
    This draft guidance also refers to previously approved collections
of information found in FDA regulations. The collections of information
in part 312 have been approved under OMB control number 0910-0014; the
collections of information in part 314 have been approved under OMB
control number 0910-0001.
    FDA estimates the burden of this collection of information as
follows:

                                     Table 1--Estimated Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of
                                     Number of     responses per
            Activity                respondents     respondent         Total         Hours per      Total hours
                                       (i.e.          (i.e.,         responses       response
                                    applicants)    applications)
----------------------------------------------------------------------------------------------------------------
Summary Level Clinical Site                   75             1.3              96              26           2,496
 Dataset Submissions............
Dataset Quality Assurance.......              75             1.3              96               1              96
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............           2,592
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this information collection.

                                   Table 2--Estimated Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of
            Activity                 Number of      records per    Total records     Hours per      Total hours
                                   recordkeepers   recordkeeper                    recordkeeper
----------------------------------------------------------------------------------------------------------------
Develop Initial SOP(s)..........              75               1              75              12             900
Maintain and Update SOP(s)......              75               1              75               1              75
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............             975
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this information collection.

IV. Electronic Access

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

    Dated: December 13, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-30510 Filed 12-18-12; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 78, Number 110 (Friday, June 7, 2013)]
[Notices]
[Pages 34410-34413]
[FR Doc No: 2013-13551]

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SECURITIES AND EXCHANGE COMMISSION

[Investment Company Act Release No. 30546; File No. 812-14070]

First Trust Exchange-Traded Fund, et al.; Notice of Application

June 3, 2013.
AGENCY: Securities and Exchange Commission (``Commission'').

ACTION: Notice of an application under section 6(c) of the Investment
Company Act of 1940 (``Act'') for an exemption from section 15(a) of
the Act and rule 18f-2 under the Act, as well as from certain
disclosure requirements.

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Summary of Application: Applicants, including exchange-traded funds
(``ETFs''), request an order that would permit them to enter into and
materially amend sub-advisory agreements without shareholder approval
and would grant relief from certain disclosure requirements.

Applicants: First Trust Exchange-Traded Fund, First Trust Exchange-
Traded Fund II, First Trust Exchange-Traded Fund III, First Trust
Exchange-Traded Fund IV, First Trust Exchange-Traded Fund V, First
Trust Exchange-Traded Fund VI, First Trust Exchange-Traded Fund VII,
First Trust Exchange-Traded AlphaDEX(R) Fund and First Trust
Exchange-Traded AlphaDEX(R) Fund II (each an ``ETF Trust''),
First Trust Series Fund (the ``Series Trust''), First Defined Portfolio
Fund, LLC (``First Defined''), First Trust Variable Insurance Trust
(``VIT'' and, together with each ETF Trust, the Series Trust, and First
Defined, each a ``Company'' and together, the ``Companies'') and First
Trust Advisors L.P. (``First Trust'' and, together with the Companies,
the ``Applicants'').

DATES: Filing Dates: The application was filed on August 24, 2012, and
amended on February 19, 2013.

Hearing or Notification of Hearing: An order granting the application
will be issued unless the Commission orders a hearing. Interested
persons may request a hearing by writing to the Commission's Secretary
and serving Applicants with a copy of the request, personally or by
mail. Hearing requests should be received by the Commission by 5:30
p.m. on June 28, 2013, and should be accompanied by proof of service on
the Applicants, in the form of an affidavit or, for lawyers, a
certificate of service. Hearing requests should state the nature of the
writer's interest, the reason for the request, and the issues
contested. Persons who wish to be notified of a hearing may request
notification by writing to the Commission's Secretary.

ADDRESSES: Elizabeth M. Murphy, Secretary, U.S. Securities and Exchange
Commission, 100 F Street NE., Washington, DC 20549-1090. Applicants,
Attn: W. Scott Jardine, 120 East Liberty Drive, Suite 400, Wheaton, IL
60187.

FOR FURTHER INFORMATION CONTACT: Steven I. Amchan, Senior Counsel, at
(202) 551-6826, or Jennifer L. Sawin, Branch Chief, at<PHONE_NUMBER>
(Division of Investment Management, Exemptive Applications Office).

SUPPLEMENTARY INFORMATION: The following is a summary of the
application. The complete application may be obtained via the
Commission's Web site by searching for the file number, or an applicant
using the Company name box, at http://www.sec.gov/search/search.htm or
by calling<PHONE_NUMBER>.

Applicants' Representations

    1. The ETF Trusts, the Series Trust, and VIT each are organized as
Massachusetts business trusts, and First Defined is organized as a
Delaware limited liability company. Each Company is, or will be,
registered under the Act as an open-end management investment
company.\1\ The ETF Trusts have received or may rely on exemptive
relief to offer series that sell their shares on a national securities
exchange at negotiated prices. As of February 19, 2013, each ETF Trust,
other than First Trust Exchange-Traded Fund V and First Trust Exchange-
Traded Fund VII, had series with publicly outstanding shares. Also as
of February 19, 2013, the Series Trust had three existing series
currently offered and sold, First Defined had eight, and VIT had one.
All Companies may offer additional series in the future.\2\
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    \1\ The Companies and all of their existing and future series
are referred to herein as ``Funds.''
    \2\ Applicants request that any relief granted pursuant to the
application apply not only to the series of the Companies but also
to any existing or future open-end management investment companies
or series thereof that (a) are advised by First Trust or any entity
controlling, controlled by or under common control with First Trust
or its successors (each such entity included with First Trust in the
term ``Advisor''), (b) are registered under the Act, (c) use a
management approach that utilizes Sub-Advisers (as defined below) as
described in the application (the ``Manager of Managers
Structure''), and (d) comply with the terms and conditions in the
application (included in the term ``Funds''); and any Advisor. The
term ``Company'' as used in the application includes any existing or
future open-end management investment company that is registered
with the Commission and advised by the Advisor. Every existing
registered open-end management investment company that currently
intends to rely on the requested order is named as an Applicant. Any
entity that relies on the order in the future will do so only in
accordance with the terms and conditions in the application. For the
purposes of the requested order, ``successor'' is limited to an
entity that results from a reorganization into another jurisdiction
or a change in the type of business organization. If the name of any
Fund relying on the requested relief contains the name of a Sub-
Adviser, the name of the Advisor that serves as the primary adviser
to that Fund, or a trademark or trade name owned by that Advisor,
will precede the name of the Sub-Adviser.
---------------------------------------------------------------------------

    2. First Trust, an Illinois limited partnership with its principal
office in Wheaton, Illinois, is registered as an investment adviser
under the Investment Advisers Act of 1940 (``Advisers Act''). First
Trust has one limited partner, Grace Partners of DuPage L.P., and one
general partner, The Charger Corporation. First Trust currently serves
as the investment adviser to the existing Funds pursuant to an
investment advisory agreement with respect to each Fund (each, an
``Advisory Agreement'') approved by the applicable board of trustees
(the ``Board'') \3\, including a majority of the trustees who are not
``interested persons,'' as defined in section 2(a)(19) of the Act (the
``Independent Trustees''), and by the shareholder(s) of each Fund in
the manner required by sections 15(a) and (c) of the Act and rule 18f-2
thereunder. With respect to new Funds offered in the future, the
Advisory Agreement will be approved by the Board, including majority of
the Independent Trustees, and by the initial shareholder of the Fund in
the manner required by sections 15(a) and (c) of the Act and rule 18f-2
thereunder.
---------------------------------------------------------------------------

    \3\ ``Board,'' as used herein, is the applicable board of
directors or trustees for each Fund, including future Funds.
---------------------------------------------------------------------------

    3. Under the terms of the applicable Advisory Agreement, the
Advisor, subject to the oversight of the Board, generally furnishes a
continuous investment program for each Fund. For the investment
management services that it provides to each Fund, the Advisor receives
the fee specified in the Advisory Agreement from each Fund based on the
Fund's average daily net assets. The terms of the Advisory Agreement
for any Fund that will use sub-advisers also permit or will permit the
Advisor, subject to the approval of the applicable Board, including a
majority of the Independent Trustees, and the approval of the
shareholders of the Fund (to the extent required by applicable law), to
delegate portfolio management responsibilities of all or a portion of
the assets of the Fund to one or more sub-advisers. With respect to
certain existing Funds the Advisor has entered into investment sub-
advisory agreements with unaffiliated sub-

advisers (each, a ``Sub-Adviser'' and such agreements, ``Sub-Advisory
Agreements'') pursuant to which the Sub-Advisers will provide
investment advisory services to those Funds. The Advisor may, in the
future, enter into Sub-Advisory Agreements with other Sub-Advisers for
one or more Funds.\4\ Each Sub-Adviser is, or will be, an investment
adviser registered under the Advisers Act, or not subject to such
registration. Each Sub-Adviser is and will be responsible, subject to
the general supervision of the Advisor and the Board, for, among other
things, the purchase and sale of securities for the applicable Fund.
The Advisor will (1) Set each Fund's overall investment strategies; (2)
evaluate, select, and recommend to the Board Sub-Advisers needed to
manage all or part of the Funds' assets; (3) monitor and evaluate each
Sub-Adviser's investment programs, results, and performance; and (4)
review each Fund's compliance with its investment objective(s),
policies and restrictions. The Advisor will also recommend to the Board
whether Sub-Advisory Agreements should be renewed, modified or
terminated. Additionally, when the Advisor employs multiple Sub-
Advisers, the Advisor will allocate, and reallocate, the Fund's assets
among Sub-Advisers. The Advisor currently compensates each Sub-Adviser
out of the advisory fees paid to the Advisor under the relevant
Advisory Agreement; in the future, subject to the terms of the
applicable Advisory Agreement and Sub-Advisory Agreement, Sub-Advised
Funds may pay advisory fees to the Sub-Advisers directly. Where the
Sub-Advisers are paid directly by the Funds, Applicants acknowledge
that, after the requested order is issued, shareholder approval will
still be sought for any amendment to a Sub-Advisory Agreement that
would increase the total management and advisory fees payable by a
Fund.
---------------------------------------------------------------------------

    \4\ Each existing Sub-Advisory Agreement (i) was approved by the
Board, including a majority of the Independent Trustees, and the
shareholders of the applicable Fund in accordance with sections
15(a) and 15(c) of the Act and rule 18f-2 thereunder and (ii)
complies fully with the requirements of section 15(a) of the Act.
---------------------------------------------------------------------------

    4. Applicants request an order to permit the Advisor, subject to
Board approval, to select certain Sub-Advisers to manage all or a
portion of the assets of a Fund pursuant to a Sub-Advisory Agreement
and materially amend Sub-Advisory Agreements without obtaining
shareholder approval. The requested relief will not extend to any sub-
adviser that is an affiliated person, as defined in section 2(a)(3) of
the Act, of a Company, a Fund, or the Advisor, other than by reason of
serving as a sub-adviser to one or more of the Funds (``Affiliated Sub-
Advisers'').
    5. Applicants acknowledge that the requested order seeks relief for
Funds that are ETFs (``ETF Funds''). However, Applicants believe that
operations of the ETF Funds under the requested order address the
concerns historically considered by the Commission when granting
identical relief to mutual funds. Applicants believe that similar to
shareholders of a mutual fund who may ``vote with their feet'' by
redeeming their individual shares at net asset value (``NAV'') if they
do not approve of a change in sub-adviser or subadvisory agreement, ETF
Fund shareholders will be able, due to the arbitrage mechanism
implemented for each ETF Fund, to sell shares in the secondary market
at negotiated prices that do not vary materially from the relevant
Fund's NAV if the shareholders do not approve of a change.
    6. Applicants also request an order exempting the Funds from
certain disclosure provisions described below that may require the
Applicants to disclose fees paid to each Sub-Adviser. Applicants seek
an order to permit each Fund to disclose (as a dollar amount and a
percentage of the Fund's net assets) only: (a) The aggregate fees paid
to the Advisor and any Affiliated Sub-Advisers; and (b) the aggregate
fees paid to Sub-Advisers (collectively, the ``Aggregate Fee
Disclosure''). A Fund that employs an Affiliated Sub-Adviser will
provide separate disclosure of any fees paid to the Affiliated Sub-
Adviser.

Applicants' Legal Analysis

    1. Section 15(a) of the Act provides, in relevant part, that it is
unlawful for any person to act as an investment adviser to a registered
investment company except pursuant to a written contract that has been
approved by the vote of a majority of the company's outstanding voting
securities. Rule 18f-2 under the Act provides that each series or class
of stock in a series investment company affected by a matter must
approve that matter if the Act requires shareholder approval.
    2. Form N-1A is the registration statement used by open-end
investment companies. Item 19(a)(3) of Form N-1A requires disclosure of
the method and amount of the investment adviser's compensation.
    3. Rule 20a-1 under the Act requires proxies solicited with respect
to an investment company to comply with Schedule 14A under the
Securities Exchange Act of 1934 (``Exchange Act''). Items 22(c)(1)(ii),
22(c)(1)(iii), 22(c)(8) and 22(c)(9) of Schedule 14A, taken together,
require a proxy statement for a shareholder meeting at which the
advisory contract will be voted upon to include the ``rate of
compensation of the investment adviser,'' the ``aggregate amount of the
investment adviser's fees,'' a description of the ``terms of the
contract to be acted upon,'' and, if a change in the advisory fee is
proposed, the existing and proposed fees and the difference between the
two fees.
    4. Regulation S-X sets forth the requirements for financial
statements required to be included as part of a registered investment
company's registration statement and shareholder reports filed with the
Commission. Sections 6-07(2)(a), (b) and (c) of Regulation S-X require
a registered investment company to include in its financial statements
information about the investment advisory fees.
    5. Section 6(c) of the Act provides that the Commission may exempt
any person, security, or transaction or any class or classes of
persons, securities, or transactions from any provisions of the Act, or
from any rule thereunder, if such exemption is necessary or appropriate
in the public interest and consistent with the protection of investors
and the purposes fairly intended by the policy and provisions of the
Act. Applicants state that the requested relief meets this standard for
the reasons discussed below.
    6. Applicants state that the shareholders expect the Advisor to
select the portfolio managers or, subject to the review and approval of
the Board, the Sub-Adviser for a Fund that is best suited to achieve
the Fund's investment objective(s). Applicants assert that, from the
perspective of the investor, the role of the Sub-Advisers with respect
to the Funds utilizing the Manager of Managers Structure is
substantially equivalent to the role of the individual portfolio
managers employed by traditional investment company advisory firms. In
the absence of exemptive relief from section 15(a) of the Act, when a
new Sub-Adviser is proposed for retention by a Fund, shareholders would
be required to approve the Sub-Advisory Agreement with that Sub-
Adviser. Similarly, approval by the shareholders of the affected Fund
would be required in order to amend an existing Sub-Advisory Agreement
in any material respect or in order to continue to retain an existing
Sub-Adviser whose Sub-Advisory Agreement is ``assigned'' as a result of
a change of control. Obtaining shareholder approval would be costly and
slow, and potentially harmful to the affected Fund and its
shareholders. Applicants note that each Advisory

Agreement will remain fully subject to the requirements of section
15(a) of the Act and rule 18f-2 under the Act, including the
requirement for shareholder voting. Moreover, the Board would comply
with the requirements of sections 15(a) and 15(c) of the Act before
entering into or amending a Sub-Advisory Agreement.
    7. If new Sub-Advisers are hired, the applicable Fund will inform
shareholders of the hiring of a new Sub-Adviser pursuant to the
following procedures (``Modified Notice and Access Procedures''): (a)
Within 90 days after a new Sub-Adviser is hired for any Fund, that Fund
will furnish its shareholders with either a Multi-manager Notice or a
Multi-manager Notice and Multi-manager Information Statement; \5\ and
(b) the Fund will make the Multi-manager Information Statement
available on the Web site identified in the Multi-manager Notice no
later than when the Multi-manager Notice (or Multi-manager Notice and
Multi-manager Information Statement) is first sent to shareholders, and
will maintain it on that Web site for at least 90 days. In the
circumstances described in the Application, a proxy solicitation to
approve the appointment of new Sub-Advisers provides no more meaningful
information to shareholders than the proposed Multi-manager Information
Statement.\6\
---------------------------------------------------------------------------

    \5\ A ``Multi-manager Notice'' will be modeled on a Notice of
Internet Availability as defined in rule 14a-16 under the Exchange
Act, and specifically will, among other things: (a) Summarize the
relevant information regarding the new Sub-Adviser; (b) inform
shareholders that the Multi-manager Information Statement is
available on a Web site; (c) provide the Web site address; (d) state
the time period during which the Multi-manager Information Statement
will remain available on that Web site; (e) provide instructions for
accessing and printing the Multi-manager Information Statement; and
(f) instruct the shareholder that a paper or email copy of the
Multi-manager Information Statement may be obtained, without charge,
by contacting the Funds.
    A ``Multi-manager Information Statement'' will meet the
requirements of Regulation 14C, Schedule 14C and Item 22 of Schedule
14A under the Exchange Act for an information statement, except as
modified by the requested order to permit Aggregate Fee Disclosure.
Multi-manager Information Statements will be filed electronically
with the Commission via the EDGAR system.
    \6\ Applicants state that the ETF Funds will rely on the
disclosure document delivery mechanisms currently used by mutual
funds that are not directly sold and by other ETFs to ensure that
shareholders who purchase in the secondary markets receive
disclosure materials.
---------------------------------------------------------------------------

    8. Applicants assert that the requested disclosure relief would
benefit Fund shareholders because it would improve the Advisor's
ability to negotiate the fees paid to Sub-Advisers. Applicants state
that the Advisor may be able to negotiate rates that are below a Sub-
Adviser's ``posted'' amounts if the Advisor is not required to disclose
the Sub-Advisers' fees to the public. Applicants submit that the
requested relief will also encourage Sub-Advisers to negotiate lower
sub-advisory fees with the Advisor if the lower fees are not required
to be made public.

Applicants' Conditions

    Applicants agree that any order granting the requested relief will
be subject to the following conditions:
    1. Before a Fund may rely on the order requested in the
application, the operation of the Fund in the manner described in the
application will be approved by a majority of the Fund's outstanding
voting securities, as defined in the Act, or, in the case of a Fund
whose public shareholders purchase shares on the basis of a prospectus
containing the disclosure contemplated by condition 2 below, by the
initial shareholder(s) before offering shares of that sub-advised Fund
to the public.
    2. The prospectus for each Fund relying on the order requested in
the application will disclose the existence, substance, and effect of
any order granted pursuant to the application. Each Fund relying on the
order requested in the application will hold itself out to the public
as utilizing the Manager of Managers Structure described in the
application. The prospectus will prominently disclose that the Advisor
has ultimate responsibility (subject to oversight by the Board) to
oversee the Sub-Advisers and recommend their hiring, termination, and
replacement.
    3. Funds will inform shareholders of the hiring of a new Sub-
Adviser within 90 days of the hiring of the new Sub-Adviser pursuant to
the Modified Notice and Access Procedures.
    4. The Advisor will not enter into a sub-advisory agreement with
any Affiliated Sub-Adviser without such agreement, including the
compensation to be paid thereunder, being approved by the shareholders
of the applicable Fund.
    5. At all times, at least a majority of the Board will be
Independent Trustees, and the nomination of new or additional
Independent Trustees will be placed within the discretion of the then-
existing Independent Trustees.
    6. Whenever a sub-adviser change is proposed for a Fund with an
Affiliated Sub-Adviser, the Board, including a majority of the
Independent Trustees, will make a separate finding, reflected in the
applicable Board minutes, that such change is in the best interests of
the Fund and its shareholders, and does not involve a conflict of
interest from which the Advisor or the Affiliated Sub-Adviser derives
an inappropriate advantage.
    7. Whenever a sub-adviser is hired or terminated, the Advisor will
provide the Board with information showing the expected impact on the
profitability of the Advisor.
    8. The Advisor will provide general management services to each
Fund that is sub-advised, including overall supervisory responsibility
for the general management and investment of the Fund's assets and,
subject to review and approval of the Board, will: (i) Set each Fund's
overall investment strategies; (ii) evaluate, select and recommend Sub-
Advisers to manage all or a part of a Fund's assets; (iii) allocate
and, when appropriate, reallocate a Fund's assets among one or more
Sub-Advisers; (iv) monitor and evaluate the performance of Sub-
Advisers; and (v) implement procedures reasonably designed to ensure
that the Sub-Advisers comply with the relevant Fund's investment
objective(s), policies and restrictions.
    9. No trustee or officer of a Company, or director, manager or
officer of the Advisor, will own directly or indirectly (other than
through a pooled investment vehicle that is not controlled by such
person), any interest in a Sub-Adviser except for: (a) Ownership of
interests in the Advisor or any entity that controls, is controlled by,
or is under common control with the Advisor, or (b) ownership of less
than 1% of the outstanding securities of any class of equity or debt of
any publicly traded company that is either a Sub-Adviser or an entity
that controls, is controlled by, or is under common control with a Sub-
Adviser.
    10. Each Fund will disclose in its registration statement the
Aggregate Fee Disclosure.
    11. In the event the Commission adopts a rule under the Act
providing substantially similar relief to that in the order requested
in the application, the requested order will expire on the effective
date of that rule.
    12. The Advisor will provide the Board, no less frequently than
quarterly, with information about the profitability of the Advisor on a
per Fund basis. The information will reflect the impact on
profitability of the hiring or termination of any sub-adviser during
the applicable quarter.
    13. Independent Legal Counsel, as defined in rule 0-1(a)(6) under
the Act, will be engaged to represent the Independent Trustees. The
selection of such counsel will be within the discretion of the then-
existing Independent Trustees.

    14. For Funds that pay fees to a Sub-Adviser directly from Fund
assets, any changes to a Sub-Advisory Agreement that would result in an
increase in the total management and advisory fees payable by a Fund
will be required to be approved by the shareholders of the Fund.

    For the Commission, by the Division of Investment Management,
under delegated authority.
Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2013-13551 Filed 6-6-13; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: January 6, 2009 (Volume 74, Number 3)]
[Notices]
[Page 488-489]
[DOCID:fr06ja09-83]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-59167; File No. SR-NYSEArca-2008-141]

Self-Regulatory Organizations; Notice of Filing and Immediate
Effectiveness of Rule Change by NYSE Arca, Inc. Implementing Fee Change

December 29, 2008.
    Pursuant to section 19(b)(1) \1\ of the Securities Exchange Act of
1934 (the ``Act'') \2\ and Rule 19b-4 thereunder,\3\ notice is hereby
given that, on December 22, 2008, NYSE Arca, Inc. (``NYSE Arca'' or the
``Exchange'') filed with the Securities and Exchange Commission (the
``Commission'') the proposed rule change as described in Items I, II,
and III below, which Items have been prepared by the self-regulatory
organization. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 15 U.S.C. 78a.
    \3\ 17 CFR 240.19b-4.

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

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to reduce the Options Orientation Fee. The
text of the proposed rule change is attached to the proposed rule
change as Exhibit 5. A copy of this filing is available on the
Exchange's Web site at http://www.nyse.com, at the Exchange's principal
office 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 self-regulatory organization
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 those 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 parts of such statements.

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

1. Purpose
    The Exchange currently charges an Options Orientation Fee of $1,000
to each applicant seeking to become a Market Maker Authorized Trader
\4\ (``MMAT'') or Floor Broker \5\ (``FB'') on the Exchange. The
Exchange proposes to reduce the Options Orientation Fee from $1,000 to
$500.
---------------------------------------------------------------------------

    \4\ See NYSE Arca Rule 6.1A(9).
    \5\ See NYSE Arca Rule 6.43.
---------------------------------------------------------------------------

    Pursuant to Exchange rules, each MMAT and FB must be approved by
the Exchange. The approval process requires each applicant to file a
Form U-4 and fingerprint cards in Web CRD. The Exchange then performs a
full background investigation and disclosure review of each applicant.
Each applicant must also demonstrate their qualification for
registration by successfully completing the Series 44 or Series 45
examination. The Options Orientation Fee is designed to cover the cost
of processing each application, including the background investigation,
disclosure review, fingerprinting fees, and the administration and
maintenance costs associated with the Series 44 and Series 45 exams.
    NYSE Arca has recently been able to reduce the fixed costs
associated with administering and maintaining the Series 44 and Series
45 exams. The Exchange believes it is appropriate to pass along those
savings to applicants taking either of the two exams. As such, the
Exchange proposes reducing the Options Orientation Fee from $1,000 to
$500. In doing so the Exchange also believes it can attract additional
market makers and floor brokers, thereby increasing participation and
liquidity on the Exchange.
    The new Options Orientation Fee would become effective on January
1, 2009.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with the provisions of section 6 of the Act,\6\ in general, and section
6(b)(4) of the Act,\7\ in particular, in that it is designed to provide
for the equitable allocation of reasonable dues, fees, and other
charges among its members and other persons using its facilities.
---------------------------------------------------------------------------

    \6\ 15 U.S.C. 78f(b).
    \7\ 15 U.S.C. 78f(b)(4).
---------------------------------------------------------------------------

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 that is not necessary or appropriate
in furtherance of the purposes of the Act.

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

    No written comments were solicited or received with respect to the
proposed rule change.

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

    The foregoing rule change is effective upon filing pursuant to
section 19(b)(3)(A) \8\ of the Act and subparagraph (f)(2) of Rule 19b-
4 \9\ thereunder, because it establishes a due, fee, or other charge
imposed by NYSE Arca.
---------------------------------------------------------------------------

    \8\ 15 U.S.C. 78s(b)(3)(A).
    \9\ 17 CFR 240.19b-4(f)(2).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission may summarily abrogate such rule change if it
appears to the Commission that such action is necessary or appropriate
in the public interest, for the protection of investors, or otherwise
in furtherance of the purposes of the Act.

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 e-mail to<EMAIL_ADDRESS>Please include
File Number SR-NYSEArca-2008-141 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-NYSEArca-2008-141. This
file number should be included on the subject line if e-mail 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 inspection
and copying in the Commission's Public Reference Room on official
business days between the hours of 10 a.m. and 3 p.m. Copies of the
filing will also be available for inspection and copying at NYSE Arca's
principal office and on its Internet Web site at http://www.nyse.com.
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-NYSEArca-2008-
141 and should be submitted on or before January 27, 2009.

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\10\
---------------------------------------------------------------------------

    \10\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Florence E. Harmon,
Acting Secretary.
[FR Doc. E8-31347 Filed 1-5-09; 8:45 am]

BILLING CODE 8011-01-P


Comment Info: =================

General Comment:Dear Mr. Zeller:

I am writing as an individual consumer to request an extension of the comment period for the Food and Drug Administration's ("FDA") Proposed Rule Deeming Tobacco Products to be Subject to the Federal Food, Drug, and Cosmetic Act, as amended by the Family Smoking and Prevention and Tobacco Control Act (the "Proposed Rule") published at 79 Fed. Reg. 23,142 and Federal Register No. 2014-09491. On behalf of myself, I am requesting that the comment period for the Proposed Rule be extended by the FDA for an additional 105days, from its current 75-day period, to 180 days.

The Proposed Rule raises a number of significant issues and questions that are important and relevant to me, as a consumer of products that are proposed for regulation under the Proposed Rule. The Proposed Rule asks about a hundred different questions I might want to respond to. I want to provide my thoughts and comments on many of these issues, but my time to devote to researching and providing thoughtful comments on these important questions is limited. I have already spent many hours researching and dissecting these issues, but they take time. I know that the FDA took many years to even come up with the Proposed Rule, so I do not think it is at all unreasonable to allow the public a mere six months to comment on it. This is our only opportunity, as consumers, to provide our feedback. It is only fair.

I believe that electronic cigarettes are a safe alternative to combustible cancer causing cigarettes. Quite simply, I firmly believe that they saved my life. I wish to provide you with my personal story, as well as science- and evidence-based responses to your questions so that you can take my comment into account. I realize that the FDA has the authority under 21 CFR 10.40 to extend this time frame and that the FDA has exercised this authority on numerous occasions in the past. I would therefore ask that you do so here, so that all stakeholders have the opportunity to provide their comments on this proposed regulation.

I appreciate your consideration of my request and am happy to discuss this issue with you further.


Mid Atlantic Fishery Management Council ø Species Managed ATLANTIC MACKEREL, SQUID & BUTTERFISH FISHERY MANAGEMENT PLAN Atlantic Mackerel Scomber scombrus Long finned Squid Loligo pealei Short finned Squid Illex illecebrosus Butterfish Peprilus triacanthus BLUEFISH FISHERY MANAGEMENT PLAN Bluefish Pomatomus saltatrix DOGFISH FISHERY MANAGEMENT PLAN Spiny Dogfish Squalus acanthias SURFCLAM & OCEAN QUAHOG FISHERY MANAGEMENT PLAN Surfclam Spisula solidissima Ocean Quahog Arctica islandica SUMMER FLOUNDER, SCUP & BLACK SEA BASS FISHERY MANAGEMENT PLAN Summer Flounder Paralichtys dentatus Scup Stenotomus chrysops Black Sea Bass Centropristis striata striata TILEFISH FISHERY MANAGEMENT PLAN Tilefish Lopholatilus chamaeleonticeps MONKFISH FISHERY MANAGEMENT PLAN Monkfish Lophius americanus


[Federal Register Volume 77, Number 94 (Tuesday, May 15, 2012)]
[Notices]
[Page 28592]
[FR Doc No: 2012-11713]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:

Filings Instituting Proceedings

    Docket Numbers: RP12-722-000.
    Applicants: Gulf South Pipeline Company, LP.
    Description: Amendments to Negotiated Rate Agreements--Add PXS and
Bistineau Points Filing 1 to be effective 5/1/2012.
    Filed Date: 5/4/12.
    Accession Number: 20120504-5102.
    Comments Due: 5 p.m. ET 5/16/12.

    Docket Numbers: RP12-723-000.
    Applicants: Williston Basin Interstate Pipeline Company.
    Description: New Pools and Receipt Points to be effective 5/4/2012.
    Filed Date: 5/4/12.
    Accession Number: 20120504-5110.
    Comments Due: 5 p.m. ET 5/16/12.

    Docket Numbers: RP12-724-000.
    Applicants: Columbia Gas Transmission, LLC.
    Description: ISS Implementation Filing to be effective 6/4/2012.
    Filed Date: 5/4/12.
    Accession Number: 20120504-5138.
    Comments Due: 5 p.m. ET 5/16/12.

    Docket Numbers: RP12-725-000.
    Applicants: Kinder Morgan Interstate Gas Transmission LLC.
    Description: Negotiated Rate--2012-05-04 DCP Midstream to be
effective 5/7/2012.
    Filed Date: 5/4/12.
    Accession Number: 20120504-5162.
    Comments Due: 5 p.m. ET 5/16/12.

    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 Sec.  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.

Filings in Existing Proceedings

    Docket Numbers: RP11-1859-001.
    Applicants: Equitrans, L.P.
    Description: Refund Report for Pipeline Safety Cost Tracker under
Docket No. RP11-1859-001 to be effective N/A.
    Filed Date: 5/7/12.
    Accession Number: 20120507-5050.
    Comments Due: 5 p.m. ET 5/21/12.

    Any person desiring to protest in any the above proceedings must
file in accordance with Rule 211 of the Commission's Regulations (18
CFR 385.211) on or before 5:00 p.m. Eastern time on the specified
comment date.
    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, and service 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 (202) 502-
8659.

    Dated: May 7, 2012.
Nathaniel J. Davis, Sr.,
Deputy Secretary
[FR Doc. 2012-11713 Filed 5-14-12; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 84, Number 233 (Wednesday, December 4, 2019)]
[Notices]
[Pages 66440-66441]
[FR Doc No: 2019-26186]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2011-0389; FMCSA-2013-0107; FMCSA-2016-0011; FMCSA-
2017-0181]

Qualification of Drivers; Exemption Applications; Epilepsy and
Seizure Disorders

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

ACTION: Notice of renewal of exemptions; request for comments.

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

SUMMARY: FMCSA announces its decision to renew exemptions for seven
individuals from the requirement in the Federal Motor Carrier Safety
Regulations (FMCSRs) that interstate commercial motor vehicle (CMV)
drivers have ``no established medical history or clinical diagnosis of
epilepsy or any other condition which is likely to cause loss of
consciousness or any loss of ability to control a CMV.'' The exemptions
enable these individuals who have had one or more seizures and are
taking anti-seizure medication to continue to operate CMVs in
interstate commerce.

DATES: Each group of renewed exemptions were applicable on the dates
stated in the discussions below and will expire on the dates stated in
the discussions below. Comments must be received on or before January
3, 2020.

ADDRESSES: You may submit comments identified by the Federal Docket
Management System (FDMS) Docket No. FMCSA-2011-0389, Docket No. FMCSA-
2013-0107, Docket No. FMCSA-2016-0011, or Docket No. FMCSA-2017-0181
using any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the online instructions for submitting
comments.
     Mail: Docket Operations; U.S. Department of
Transportation, 1200 New Jersey Avenue SE, West Building Ground Floor,
Room W12-140, Washington, DC 20590-0001.
     Hand Delivery: West Building Ground Floor, Room W12-140,
1200 New Jersey Avenue SE, Washington, DC, between 9 a.m. and 5 p.m.,
ET, Monday through Friday, except Federal Holidays.
     Fax:<PHONE_NUMBER>.
    To avoid duplication, please use only one of these four methods.
See the ``Public Participation'' portion of the SUPPLEMENTARY
INFORMATION section for instructions on submitting comments.

FOR FURTHER INFORMATION CONTACT: Ms. Christine A. Hydock, Chief,
Medical Programs Division,<PHONE_NUMBER><EMAIL_ADDRESS>FMCSA,
Department of Transportation, 1200 New Jersey Avenue SE, Room W64-224,
Washington, DC 20590-0001. Office hours are from 8:30 a.m. to 5 p.m.,
ET, Monday through Friday, except Federal holidays. If you have
questions regarding viewing or submitting material to the docket,
contact Docket Operations,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Public Participation

A. Submitting Comments

    If you submit a comment, please include the docket number for this
notice (Docket No. FMCSA-2011-0389, FMCSA-2013-0107, FMCSA-2016-0011,
or FMCSA-2017-0181), indicate the specific section of this document to
which each comment applies, and provide a reason for each suggestion or
recommendation. You may submit your comments and material online or by
fax, mail, or hand delivery, but please use only one of these means.
FMCSA recommends that you include your name and a mailing address, an
email address, or a phone number in the body of your document so that
FMCSA can contact you if there are questions regarding your submission.
    To submit your comment online, go to http://www.regulations.gov,
put the docket number, FMCSA-2011-0389, FMCSA-2013-0107, FMCSA-2016-
0011, or FMCSA-2017-0181, in the keyword box, and click ``Search.''
When the new screen appears, click on the ``Comment Now!'' button and
type your comment into the text box on the following screen. Choose
whether you are submitting your comment as an individual or on behalf
of a third party and then submit.
    If you submit your comments by mail or hand delivery, submit them
in an unbound format, no larger than 8\1/2\ by 11 inches, suitable for
copying and electronic filing. If you submit comments by mail and would
like to know that they reached the facility, please enclose a stamped,
self-addressed postcard or envelope.
    FMCSA will consider all comments and material received during the
comment period.

B. Viewing Documents and Comments

    To view comments, as well as any documents mentioned in this notice
as being available in the docket, go to http://www.regulations.gov.
Insert the docket number, FMCSA-2011-0389, FMCSA-2013-0107, FMCSA-2016-
0011, or FMCSA-2017-0181, in the keyword box, and click ``Search.''
Next, click the ``Open Docket Folder'' button and choose the document
to review. If you do not have access to the internet, you may view the
docket online by visiting Docket Operations in Room W12-140 on the
ground floor of the DOT West Building, 1200 New Jersey Avenue SE,
Washington, DC 20590, between 9 a.m. and 5 p.m., ET, Monday through
Friday, except Federal holidays.

C. Privacy Act

    In accordance with 5 U.S.C. 553(c), DOT solicits comments from the
public to better inform its rulemaking process. DOT posts these
comments, without edit, including any personal information the
commenter provides, to www.regulations.gov, as described in the system
of records notice (DOT/ALL-14 FDMS), which can be reviewed at
www.dot.gov/privacy.

II. Background

    Under 49 U.S.C. 31136(e) and 31315(b), FMCSA may grant an exemption
from the FMCSRs for no longer than a 5-year period if it finds such
exemption would likely achieve a level of safety that is equivalent to,
or greater than, the level that would be achieved absent such
exemption. The statute also allows the Agency to renew exemptions at
the end of the 5-year period. FMCSA grants medical exemptions from the
FMCSRs for a 2-year period to align with the maximum duration of a
driver's medical certification.
    The physical qualification standard for drivers regarding epilepsy
found in 49 CFR 391.41(b)(8) states that a person is physically
qualified to drive a CMV if that person has no established medical
history or clinical diagnosis of epilepsy or any other condition which
is likely to cause the loss of consciousness or any loss of ability to
control a CMV.

    In addition to the regulations, FMCSA has published advisory
criteria \1\ to assist medical examiners (MEs) in determining whether
drivers with certain medical conditions are qualified to operate a CMV
in interstate commerce.
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    \1\ These criteria may be found in APPENDIX A TO PART 391--
MEDICAL ADVISORY CRITERIA, section H. Epilepsy: Sec.  391.41(b)(8),
paragraphs 3, 4, and 5, which is available on the internet at
https://www.gpo.gov/fdsys/pkg/CFR-2015-title49-vol5/pdf/CFR-2015-title49-vol5-part391-appA.pdf.
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    The seven individuals listed in this notice have requested renewal
of their exemptions from the epilepsy and seizure disorders prohibition
in Sec.  391.41(b)(8), in accordance with FMCSA procedures.
Accordingly, FMCSA has evaluated these applications for renewal on
their merits and decided to extend each exemption for a renewable 2-
year period.

III. Request for Comments

    Interested parties or organizations possessing information that
would otherwise show that any, or all, of these drivers are not
currently achieving the statutory level of safety should immediately
notify FMCSA. The Agency will evaluate any adverse evidence submitted
and, if safety is being compromised or if continuation of the exemption
would not be consistent with the goals and objectives of 49 U.S.C.
31136(e) and 31315(b), FMCSA will take immediate steps to revoke the
exemption of a driver.

IV. Basis for Renewing Exemptions

    In accordance with 49 U.S.C. 31136(e) and 31315(b), each of the
seven applicants has satisfied the renewal conditions for obtaining an
exemption from the epilepsy and seizure disorders prohibition. The
seven drivers in this notice remain in good standing with the Agency,
have maintained their medical monitoring and have not exhibited any
medical issues that would compromise their ability to safely operate a
CMV during the previous 2-year exemption period. In addition, for
Commercial Driver's License (CDL) holders, the Commercial Driver's
License Information System and the Motor Carrier Management Information
System are searched for crash and violation data. For non-CDL holders,
the Agency reviews the driving records from the State Driver's
Licensing Agency. These factors provide an adequate basis for
predicting each driver's ability to continue to safely operate a CMV in
interstate commerce. Therefore, FMCSA concludes that extending the
exemption for each renewal applicant for a period of 2 years is likely
to achieve a level of safety equal to that existing without the
exemption.
    In accordance with 49 U.S.C. 31136(e) and 31315(b), the following
groups of drivers received renewed exemptions in the month of November
and are discussed below.
    As of November 6, 2019, and in accordance with 49 U.S.C. 31136(e)
and 31315(b), the following four individuals have satisfied the renewal
conditions for obtaining an exemption from the epilepsy and seizure
disorders prohibition in the FMCSRs for interstate CMV drivers:

Christopher Bird (OH)
Ronald Bohr (IA)
Joseph D'Angelo (NY)
Craig Lasecki (WI)

    The drivers were included in docket numbers FMCSA-2011-0389; FMCSA-
2013-0107; and FMCSA-2016-0011. Their exemptions are applicable as of
November 6, 2019, and will expire on November 6, 2021.
    As of November 14, 2019, and in accordance with 49 U.S.C. 31136(e)
and 31315(b), the following three individuals have satisfied the
renewal conditions for obtaining an exemption from the epilepsy and
seizure disorders prohibition in the FMCSRs for interstate CMV drivers:
Gary J. Gress (PA); Kenneth Lewis (NC); and Sean Moran (MA).
    The drivers were included in docket number FMCSA-2017-0181. Their
exemptions are applicable as of November 14, 2019, and will expire on
November 14, 2021.

V. Conditions and Requirements

    The exemptions are extended subject to the following conditions:
(1) Each driver must remain seizure-free and maintain a stable
treatment during the 2-year exemption period; (2) each driver must
submit annual reports from their treating physicians attesting to the
stability of treatment and that the driver has remained seizure-free;
(3) each driver must undergo an annual medical examination by a
certified ME, as defined by Sec.  390.5; and (4) each driver must
provide a copy of the annual medical certification to the employer for
retention in the driver's qualification file, or keep a copy of his/her
driver's qualification file if he/she is self-employed. The driver must
also have a copy of the exemption when driving, for presentation to a
duly authorized Federal, State, or local enforcement official. The
exemption will be rescinded if: (1) The person fails to comply with the
terms and conditions of the exemption; (2) the exemption has resulted
in a lower level of safety than was maintained before it was granted;
or (3) continuation of the exemption would not be consistent with the
goals and objectives of 49 U.S.C. 31136(e) and 31315(b).

VI. Preemption

    During the period the exemption is in effect, no State shall
enforce any law or regulation that conflicts with this exemption with
respect to a person operating under the exemption.

VII. Conclusion

    Based on its evaluation of the seven exemption applications, FMCSA
renews the exemptions of the aforementioned drivers from the epilepsy
and seizure disorders prohibition in Sec.  391.41(b)(8). In accordance
with 49 U.S.C. 31136(e) and 31315(b), each exemption will be valid for
2 years unless revoked earlier by FMCSA.

    Issued on: November 26, 2019.
Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2019-26186 Filed 12-3-19; 8:45 am]
BILLING CODE 4910-EX-P