[Federal Register Volume 78, Number 32 (Friday, February 15, 2013)]
[Notices]
[Pages 11174-11175]
[FR Doc No: 2013-03598]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OAR-2007-1196; FRL-9781-1]

Recent Postings of Broadly Applicable Alternative Test Methods

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of availability.

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SUMMARY: This notice announces the broadly applicable alternative test
method approval decisions the EPA has made under and in support of New
Source Performance Standards (NSPS) and the National Emission Standards
for Hazardous Air Pollutants (NESHAP) under the Clean Air Act (CAA) in
2012.

FOR FURTHER INFORMATION CONTACT: An electronic copy of each alternative
test method approval document is available on the EPA's Web site at
www.epa.gov/ttn/emc/approalt.html. For questions about this notice,
contact Ms. Lula H. Melton, Air Quality Assessment Division, Office of
Air Quality Planning and Standards (E143-02), Environmental Protection
Agency, Research Triangle Park, NC 27711; telephone number: 919-541-
2910; fax number:<PHONE_NUMBER>; email address<EMAIL_ADDRESS>For
technical questions about individual alternative test method decisions,
refer to the contact person identified in the individual approval
documents.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this notice apply to me?

    This notice will be of interest to entities regulated under 40 Code
of Federal Regulations (CFR) parts 60, 61, and 63, state, local, and
tribal agencies, and the EPA Regional Offices responsible for
implementation and enforcement of regulations under 40 CFR parts 60,
61, and 63.

B. How can I get copies of this information?

    You may access copies of the broadly applicable alternative test
method approval documents from the EPA's Web site at www.epa.gov/ttn/emc/approalt.html.

II. Background

    Broadly applicable alternative test method approval decisions made
by the EPA in 2012 under the NSPS, 40 CFR part 60 and the NESHAP, and
40 CFR parts 61 and 63 are identified in this notice (see Table 1).
Source owners and operators may voluntarily use these broadly
applicable alternative test methods subject to their specific
applicability. Use of these broadly applicable alternative test methods
does not change the applicable emission standards.
    As explained in a previous Federal Register notice published at 72
FR 4257 (January 30, 2007) and found on the EPA's Web site at
www.epa.gov/ttn/emc/approalt.html, the EPA Administrator has the
authority to approve the use of alternative test methods to comply with
requirements under 40 CFR parts 60, 61, and 63. This authority is found
in sections 60.8(b)(3), 61.13(h)(1)(ii), and 63.7(e)(2)(ii). In the
past, we have performed thorough technical reviews of numerous requests
for alternatives and modifications to test methods and procedures.
Based on these reviews, we have often found that these changes or
alternatives would be equally valid and appropriate to apply to other
sources within a particular class, category, or subcategory.
Consequently, we have concluded that, where a method modification or an
alternative method is clearly broadly applicable to a class, category,
or subcategory of sources, it is both more equitable and efficient to
approve its use for all appropriate sources and situations at the same
time.
    It is important to clarify that alternative methods are not
mandatory but permissive. Sources are not required to employ such a
method but may choose to do so in appropriate cases. Source owners or
operators should review the specific broadly applicable alternative
method approval decision on the EPA's Web site at www.epa.gov/ttn/emc/approalt.html before electing to employ it. As per 63.7(f)(5), by
electing to use an alternative method for 40 CFR part 63 standards, the
source owner or operator must continue to use the alternative method
until approved otherwise.
    The criteria for approval and procedures for submission and review
of broadly applicable alternative test methods are outlined at 72 FR
4257 (January 30, 2007). We will continue to announce approvals for
broadly applicable alternative test methods on the EPA's Web site at
www.epa.gov/ttn/emc/approalt.html and annually publish a notice that
summarizes approvals for broadly applicable alternative test methods.
    This notice comprises a summary of seven such approval documents
added to our Technology Transfer Network from January 1, 2012, through
December 31, 2012. The alternative method decision letter/memo number,
the reference method affected, sources allowed to use this alternative,
and the modification or alternative method allowed are summarized in
Table 1 of this notice. Please refer to the complete copies of these
approval documents available from the EPA's Web site at www.epa.gov/ttn/emc/approalt.html as Table 1 serves only as a brief summary of the
broadly applicable alternative test methods. In addition to alternative
decisions listed in Table 1, we received comments and updated
Alternative-082, which was approved the previous year in 2011. This
alternative approval letter can also be viewed at www.epa.gov/ttn/emc/approalt.html.
    If you are aware of reasons why a particular alternative test
method approval that we issued should not be broadly applicable, we
request that you make us aware of the reasons in writing, and we will
revisit the broad approval. Any objection to a broadly applicable
alternative test method, as well as the resolution of that objection,
will be announced on the EPA's Web site at www.epa.gov/ttn/emc/approalt.html and in the subsequent Federal Register notice. If we
decide to retract a broadly applicable test method, we would continue
to grant case-by-case approvals, as appropriate, and would (as

states, local and tribal agencies and the EPA Regional Offices should)
consider the need for an appropriate transition period for users either
to request case-by-case approval or to transition to an approved
method.

    Dated: February 8, 2013.
Mary E. Henigin,
Acting Director, Office of Air Quality Planning and Standards.

  Table 1--Approved Alternative Test Methods and Modifications to Test
 Methods Referenced in or Published Under Appendices in 40 CFR Parts 60,
         61, and 63 Made Between January 2012 and December 2012
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                            As an
  Alternative method    alternative or
 decision letter/memo  modification to     For . . .      You may . . .
         No.                . . .
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ALT-091..............  Method 4-        Sources subject  Use alternative
                        Determination    to 40 CFR part   procedures in
                        of Moisture      63, subpart      lieu of Method
                        Content in       UUUUU-National   4 to determine
                        Stack Gases.     Emission         the moisture
                                         Standards for    content of the
                                         Hazardous Air    stack gas
                                         Pollutants:      during low
                                         Coal- and Oil-   emitting EGU
                                         Fired Electric   (LEE)testing
                                         Utility Steam    for mercury
                                         Generating       emissions.
                                         Units.
ALT-092..............  Method 7E-       Natural gas      Use a single 10
                        Determination    burning          ppm (or less)
                        of Nitrogen      internal         calibration
                        Oxides           combustion       gas in lieu of
                        Emissions from   engines          a three-point
                        Stationary       subject to 40    calibration
                        Sources          CFR part 60,     for
                        (Instrumental    subpart JJJJ-    determination
                        Analyzer         Standards of     of NO2 when
                        Procedure).      Performance      the NO2
                                         for Stationary   emissions
                                         Spark Ignition   remain below
                                         Internal         10 ppm.
                                         Combustion
                                         Engines.
ALT-093..............  Method 5-        Sources subject  Use alternative
                        Determination    to 40 CFR part   test
                        of Particulate   63, subpart      procedures for
                        Matter           RRR-National     batch
                        Emissions from   Emission         processes
                        Stationary       Standards for    subject to 40
                        Sources.         Hazardous Air    CFR
                                         Pollutants for   63.1511(b)(3)
                                         Secondary        that are
                                         Aluminum         required to be
                                         Production.      sampled using
                                                          an isokinetic
                                                          train.
ALT-094..............  Measure total    Sources subject  Use a sample
                        sulfides using   to 40 CFR part   conditioning,
                        an H2S and CS2   63, subpart      sample
                        CEMS.            UUUU-National    conversion,
                                         Emission         and SO2 CEMS
                                         Standards for    in place of
                                         Hazardous Air    H2S and CS2
                                         Pollutants for   CEMS to
                                         Cellulose        measure total
                                         Products         sulfides at
                                         Manufacturing.   process vents.
ALT-095..............  Calculating the  Sources subject  Use the flow
                        coke burn-off    to 40 CFR part   rate CEMS and
                        rate for         60, subpart J-   Equation 2 of
                        compliance       Standards of     40 CFR
                        with 40 CFR      Performance      63.1573(a)(2).
                        60.105(c).       for Petroleum
                                         Refineries.
ALT-096..............  Method 25A-      Sources subject  Use the TECO-
                        Determination    to 40 CFR part   551 to measure
                        of Total         60, subpart      methane and
                        Gaseous          JJJJ-Standards   NMOC.
                        Organic          of Performance
                        Concentration    for Stationary
                        Using a Flame    Spark Ignition
                        Ionization       Internal
                        Analyzer and     Combustion
                        Method 18-       Engines.
                        Measurment of
                        Gaseous
                        Organic
                        Compound
                        Emissions by
                        Gas
                        Chromatography.
ALT-097..............  Method 25A-      Bypass flare     Use GC and GC
                        Determination    exhaust          back-flush
                        of Total         emissions        procedures to
                        Gaseous          subject to 40    separate and
                        Organic          CFR part 60,     measure
                        Concentration    subpart WWW-     methane and
                        Using a Flame    Standards of     NMOC.
                        Ionization       Performance
                        Analyzer and     for Municipal
                        Method 18-       Solid Waste
                        Measurment of    Landfills.
                        Gaseous
                        Organic
                        Compound
                        Emissions by
                        Gas
                        Chromatography.
------------------------------------------------------------------------
Source owners or operators should review the specific broadly applicable
  alternative method approval letter on the EPA's Web site at
  www.epa.gov/ttn/emc/approalt.html before electing to employ it.

[FR Doc. 2013-03598 Filed 2-14-13; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 82, Number 236 (Monday, December 11, 2017)]
[Notices]
[Pages 58260-58262]
[FR Doc No: 2017-26596]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2005-20027; FMCSA-2005-20560; FMCSA-2006-26653;
FMCSA-2007-27333; FMCSA-2008-0021; FMCSA-2008-0398; FMCSA-2009-0054;
FMCSA-2009-0121; FMCSA-2010-0327; FMCSA-2010-0413; FMCSA-2011-0024;
FMCSA-2011-0092; FMCSA-2011-0102; FMCSA-2012-0338; FMCSA-2013-0022;
FMCSA-2013-0027; FMCSA-2013-0028; FMCSA-2014-0302; FMCSA-2014-0304;
FMCSA-2014-0305; FMCSA-2014-0048; FMCSA-2015-0049; FMCSA-2015-0052]

Qualification of Drivers; Exemption Applications; Vision

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

ACTION: Notice of final disposition.

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SUMMARY: FMCSA announces its decision to renew exemptions for 88
individuals from the vision requirement in the Federal Motor Carrier
Safety

Regulations (FMCSRs) for interstate commercial motor vehicle (CMV)
drivers. The exemptions enable these individuals to continue to operate
CMVs in interstate commerce without meeting the vision requirement in
one eye.

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.

FOR FURTHER INFORMATION CONTACT: Ms. Christine A. Hydock, Chief,
Medical Programs Division,<PHONE_NUMBER>, [email protected], 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 Services, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Electronic Access

    You may see all the comments online through the Federal Document
Management System (FDMS) at: http://www.regulations.gov.
    Docket: For access to the docket to read background documents or
comments, go to http://www.regulations.gov and/or Room W12-140 on the
ground level of the West Building, 1200 New Jersey Avenue SE.,
Washington, DC, between 9 a.m. and 5 p.m., ET, Monday through Friday,
except Federal holidays.
    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 http://www.regulations.gov, as described in
the system of records notice (DOT/ALL-14 FDMS), which can be reviewed
at http://www.dot.gov/privacy.

II. Background

    On July 20, 2017, FMCSA published a notice announcing its decision
to renew exemptions for 88 individuals from the vision requirement in
49 CFR 391.41(b)(10) to operate a CMV in interstate commerce and
requested comments from the public (82 FR 33542). The public comment
period ended on August 21, 2017 and no comments were received.
    As stated in the previous notice, FMCSA has evaluated the
eligibility of these applicants and determined that renewing these
exemptions would achieve a level of safety equivalent to or greater
than the level that would be achieved by complying with the current
regulation 49 CFR 391.41(b)(10).
    The physical qualification standard for drivers regarding vision
found in 49 CFR 391.41(b)(10) states that a person is physically
qualified to driver a CMV if that person has distant visual acuity of
at least 20/40 (Snellen) in each eye without corrective lenses or
visual acuity separately corrected to 20/40 (Snellen) or better with
corrective lenses, distant binocular acuity of a least 20/40 (Snellen)
in both eyes with or without corrective lenses, field of vision of at
least 70[deg] in the horizontal meridian in each eye, and the ability
to recognize the colors of traffic signals and devices showing red,
green, and amber.

III. Discussion of Comments

    FMCSA received no comments in this preceding.

VI. Conclusion

    Based upon its evaluation of the 88 renewal exemption applications
and comments received, FMCSA confirms its' decision to exempt the
following drivers from the vision requirement in 49 CFR 391.41 (b)(10):
    In accordance with 49 U.S.C. 31136(e) and 31315, the following
groups of drivers received renewed exemptions in the month of July and
are discussed below:
    As of July 2, 2017, and in accordance with 49 U.S.C. 31136(e) and
31315, the following 32 individuals have satisfied the renewal
conditions for obtaining an exemption from the vision requirement in
the FMCSRs for interstate CMV drivers (70 FR 2701; 70 FR 16887; 70 FR
17504; 70 FR 30997; 72 FR 8417; 72 FR 27624; 72 FR 36099; 73 FR 15567;
73 FR 27015; 74 FR 7097; 74 FR 11988; 74 FR 15584; 74 FR 19270; 74 FR
21427; 74 FR 21796; 74 FR 26466; 75 FR 19674; 75 FR 65057; 76 FR 17481;
76 FR 25762; 76 FR 25766; 76 FR 28125; 76 FR 37173; 76 FR 37885; 77 FR
23797; 77 FR 74731; 78 FR 800; 78 FR 12811; 78 FR 12815; 78 FR 22596;
78 FR 22602; 78 FR 24300; 78 FR 26106; 78 FR 37270; 78 FR 57679; 79 FR
23797; 80 FR 603; 80 FR 12248; 80 FR 14220; 80 FR 14223; 80 FR 16502;
80 FR 18696; 80 FR 22773; 80 FR 25766; 80 FR 26139; 80 FR 26320; 80 FR
29152; 80 FR 31640; 80 FR 31957; 80 FR 33011; 80 FR 45573; 80 FR
48409):

Michael W. Anderson (NM)
Michael R. Bradford (MD)
Ralph H. Bushman (IL)
William D. Cardiff (IL)
John J. Caricola, Jr. (NC)
Adan Cortes-Juarez (WA)
David L. Ellis (OK)
Denise M. Engle (GA)
Robert A. Goerl, Jr. (PA)
Wade M. Hillmer (MN)
Paul M. Hinkson (TN)
Michael W. Jensen (CA)
Clifford D. Johnson (VA)
Michael Lafferty (ID)
Mark L. LeBlanc (MN)
Michael J. McGregan (FL)
Felix L. McLean (NM)
Anthony R. Miles (NV)
Jerry D. Paul (OK)
John P. Perez (FL)
Raymond W. Pitts (FL)
William A. Ramirez Vasquez (CA)
Donald W. Randall (OR)
Raymond Sherrill (PA)
Kyle C. Shover (NJ)
Charles H. Smith (IN)
George Stapleton (GA)
David B. Stone (OK)
David M. Stout (OR)
James K. Waites (AR)
John E. Westbrook (LA)
Jason R. White (OH)

    The drivers were included in docket numbers FMCSA-2005-20027;
FMCSA-2005-20560; FMCSA-2006-26653; FMCSA-2008-0021; FMCSA-2008-0398;
FMCSA-2009-0054; FMCSA-2010-0327; FMCSA-2011-0024; FMCSA-2011-0092;
FMCSA-2012-0338; FMCSA-2013-0022; FMCSA-2014-0302; FMCSA-2014-0304;
FMCSA-2014-0305; FMCSA-2015-0048. Their exemptions are applicable as of
July 2, 2017, and will expire on July 2, 2019.
    As of July 7, 2017, and in accordance with 49 U.S.C. 31136(e) and
31315, the following eight individuals have satisfied the renewal
conditions for obtaining an exemption from the vision requirements (80
FR 31636; 80 FR 48413):
Robert A. Buckley (IN)
Jose J. Guzman-Olguin (IL)
Stephen T. Hines (NJ)
James J. Keranen (MI)
Herbert S. Lear (PA)
Nathan C. Nissen (IA)
Gregory S. Richter (PA)
George Tomecek (PA)

    The drivers were included in docket number FMCSA-2015-0049. Their
exemptions are applicable as of July 7, 2017, and will expire on July
7, 2019.
    As of July 9, 2017, and in accordance with 49 U.S.C. 31136(e) and
31315, the following five individuals have satisfied the renewal
conditions for obtaining an exemption from the vision requirements (78
FR 41188; 78 FR 27281; 78 FR 41188; 80 FR 33007):

Brian G. Dvorak (IL)
Charles T. Spears (VA)
Brian E. Tessman (WI)
Gregory J. Thurston (PA)
Donald Torbett (IA)

    The drivers were included in docket number FMCSA-2013-0028. Their
exemptions are applicable as of July 9, 2017, and will expire on July
9, 2019.
    As of July 16, 2017, and in accordance with 49 U.S.C. 31136(e) and
31315, the following seven individuals have satisfied the renewal
conditions for obtaining an exemption from the vision requirements (74
FR 26461; 74 FR 34630; 76 FR 1493; 76 FR 12408; 76 FR 37168; 78 FR
51269):

Steven L. Forristall (WI)
Rocky D. Gysberg (MN)
Charles H. Lefew (VA)
Joseph B. Peacock (NC)
James M. Tennyson (MD)
Steven L. Thomas (IN)
Daniel A. Wescott (CO)

    The drivers were included in docket numbers FMCSA-2009-0413; FMCSA-
2009-0121. Their exemptions are applicable as of July 16, 2017, and
will expire on July 16, 2019.
    As of July 22, 2017, and in accordance with 49 U.S.C. 31136(e) and
31315, the following 12 individuals have satisfied the renewal
conditions for obtaining an exemption from the vision requirements (72
FR 72666; 72 FR 25831; 74 FR 19270; 76 FR 29022; 76 FR 34135; 76 FR
44082; 78 FR 34140; 78 FR 51268; 80 FR 36398):

Stanley C. Anders (SD)
Joel A. Cabrera (FL)
Sherman W. Clapper (ID)
Eric Esplin (UT)
Ronald R. Fournier (NY)
Ronald D. Jackman II (NV)
Thomas W. Kent (IN)
Robert J. MacInnis (MA)
Steven A. Proctor (TX)
Rodney W. Sukalski (MN)
Larry D. Warneke (WA)
Lonnie Wendinger (MN)

    The drivers were included in docket numbers FMCSA-2007-27333;
FMCSA-2011-0102. Their exemptions are applicable as of July 22, 2017,
and will expire on July 22, 2019.
    As of July 23, 2017, and in accordance with 49 U.S.C. 31136(e) and
31315, the following 19 individuals have satisfied the renewal
conditions for obtaining an exemption from the vision requirements (80
FR 35699; 80 FR 48404):

Robert J. Bickel (MI)
Steven R. Brinegar (TX)
Garry D. Burkholder (PA)
Dennis W. Cosens (NM)
William J. Garigulo (OH)
Wladyslaw Gogola (IL)
Antonio Gomez (PA)
Mark A. Grenier (CT)
Acquillious Jackson, III (SC)
Jimmy D. Johnson, II (TN)
Bradley J. Kearl (UT)
Larry G. Kreke (IL)
Christopher P. Mrockza (MD)
Gary A. Oster (OR)
Mark A. Pleskovitch (IL)
Edward J. Puto (CT)
Andrew P. Risner (OH)
Kyle B. Sharp (MI)
Francis A. St. Pierre (NH)

    The drivers were included in docket number FMCSA-2015-0052. Their
exemptions are applicable as of July 23, 2017, and will expire on July
23, 2019.
    As of July 31, 2017, and in accordance with 49 U.S.C. 31136(e) and
31315, the following five individuals have satisfied the renewal
conditions for obtaining an exemption from the vision requirements (76
FR 25766; 76 FR 37885; 78 FR 37270; 80 FR 31640):

Anthony Luciano (CT)
David McKinney (OR)
Frank L. O'Rourke (NY)
Larry F. Reber (OH)
Edward Swaggerty, Jr. (OH)

    The drivers were included in docket number FMCSA-2011-0192. Their
exemptions are applicable as of July 31, 2017, and will expire on July
31, 2019.
    In accordance with 49 U.S.C. 31315, each exemption will be valid
for two years from the effective date unless revoked earlier by FMCSA.
The exemption will be revoked if the following occurs: (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
prior to being granted; or (3) continuation of the exemption would not
be consistent with the goals and objectives of 49 U.S.C. 31136 and
31315.

    Issued on: December 4, 2017.
Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2017-26596 Filed 12-8-17; 8:45 am]
 BILLING CODE 4910-EX-P


[Federal Register Volume 83, Number 244 (Thursday, December 20, 2018)]
[Notices]
[Pages 65385-65386]
[FR Doc No: 2018-27516]

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SECURITIES AND EXCHANGE COMMISSION

[Investment Company Act Release No. 33323; 812-14893]

Investment Managers Series Trust and 361 Capital, LLC

December 14, 2018.
AGENCY: Securities and Exchange Commission (``Commission'').

ACTION: Notice.

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    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 in rule 20a-1 under the Act, Item 19(a)(3) of
Form N-1A, Items 22(c)(1)(ii), 22(c)(1)(iii), 22(c)(8) and 22(c)(9) of
Schedule 14A under the Securities Exchange Act of 1934, and sections 6-
07(2)(a), (b), and (c) of Regulation S-X (``Disclosure Requirements'').
The requested exemption would permit an investment adviser to hire and
replace certain sub-advisers without shareholder approval and grant
relief from the Disclosure Requirements as they relate to fees paid to
the sub-advisers.

Applicants:  Investment Managers Series Trust (the ``Trust''), a
Delaware statutory trust registered under the Act as an open-end
management investment company, and 361 Capital, LLC (the ``Adviser''),
a Delaware limited liability company registered as an investment
adviser under the Investment Advisers Act of 1940 (together with the
Trust, the ``Applicants'').

Filing Dates:  The application was filed on April 5, 2018 and amended
on August 16, 2018.

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 January 8, 2019, and should be accompanied by proof of service
on the applicants, in the form of an affidavit or, for lawyers, a
certificate of service. Pursuant to rule 0-5 under the Act, hearing
requests should state the nature of the writer's interest, any facts
bearing upon the desirability of a hearing on the matter, 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: Secretary, U.S. Securities and Exchange Commission, 100 F
Street NE, Washington, DC 20549-1090. Applicants: 235 West Galena
Street, Milwaukee, WI 53212 and 4600 South Syracuse Street, Suite 500,
Denver, Colorado 80237.

FOR FURTHER INFORMATION CONTACT: Deepak T. Pai, Senior Counsel, at
(202) 551-6876, or Andrea Ottomanelli Magovern, Branch Chief, at (202)
551-6821 (Division of Investment Management, Chief Counsel's Office).

SUPPLEMENTARY INFORMATION: The following is a summary of the
application. The complete application may be obtained via the
Commission's website 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>.
    Summary of the Application:
    1. The Adviser will serve as the investment adviser to the
Subadvised Series pursuant to an investment advisory agreement with the
Trust (each, an ``Investment Management Agreement'' and, collectively,
the ``Investment Management Agreements'').\1\ The Adviser will

provide the Subadvised Series with continuous and comprehensive
investment management services, subject to the supervision of, and
policies established by, the Trust's board of trustees (the ``Board'').
The Investment Management Agreement permits the Adviser, subject to the
approval of the Board, to delegate to one or more Sub-Advisers the
responsibility to provide the day-to-day portfolio investment
management of each Subadvised Series, subject to the supervision and
direction of the Adviser.\2\ The primary responsibility for managing
the Subadvised Series will remain vested in the Adviser. The Adviser
will hire, evaluate, allocate assets to and oversee the Sub-Advisers,
including determining whether a Sub-Adviser should be terminated, at
all times subject to the authority of the Board.
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    \1\ Applicants request relief with respect to any existing or
future series of the Trust and any other existing or future
registered open-end management company or series thereof that
intends to rely on the requested order and that: (a) Is advised by
the Adviser, or any person controlling, controlled by or under
common control with the Adviser or its successors; (b) uses the
multi-manager structure described in the application; and (c)
complies with the terms and conditions of the application (each, a
``Subadvised Series''). For 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.
    \2\ A ``Sub-Adviser'' for a Subadvised Series is an investment
sub-adviser for that Series that is not an ``affiliated person'' (as
such term is defined in Section 2(a)(3) of the Act) of the
Subadvised Series or the Adviser, except to the extent that an
affiliation arises solely because the Sub-Adviser serves as a sub-
adviser to one or more Subadvised Series (each a ``Non-Affiliated
Sub-Adviser'' and collectively, the ``Non-Affiliated Sub-
Advisers'').
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    2. Applicants request an exemption to permit the Adviser, subject
to Board approval, to hire a Non-Affiliated Sub-Adviser, pursuant to
Sub-Advisory Agreements and materially amend Sub-Advisory Agreements
with Non-Affiliated Sub-Advisers without obtaining the shareholder
approval required under section 15(a) of the Act and rule 18f-2 under
the Act.\3\ Applicants also seek an exemption from the Disclosure
Requirements to permit a Subadvised Series to disclose (as both a
dollar amount and a percentage of the Subadvised Series' net assets):
(a) The aggregate fees paid to the Adviser; (b) the aggregate fees paid
to Non-Affiliated Sub-Advisers; and (c) the fee paid to each Affiliated
Sub-Adviser.
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    \3\ The requested relief will not extend to any sub-adviser
which is an affiliated person, as defined in section 2(a)(3) of the
Act, of the Subadvised Series or of its Adviser, other than by
reason of serving as a sub-adviser to one or more of the Subadvised
Series (``Affiliated Sub-Adviser'').
---------------------------------------------------------------------------

    3. Applicants agree that any order granting the requested relief
will be subject to the terms and conditions stated in the application.
Such terms and conditions provide for, among other safeguards,
appropriate disclosure to Subadvised Series' shareholders and
notification about sub-advisory changes and enhanced Board oversight to
protect the interests of the Subadvised Series' shareholders.
    4. 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
any rule thereunder, if such relief is necessary or appropriate in the
public interest and consistent with the protection of investors and
purposes fairly intended by the policy and provisions of the Act.
Applicants believe that the requested relief meets this standard
because, as further explained in the application, the Investment
Management Agreements will remain subject to shareholder approval while
the role of the Sub-Advisers is substantially equivalent to that of
individual portfolio managers, so that requiring shareholder approval
of Sub-Advisory Agreements would impose unnecessary delays and expenses
on the Subadvised Series. Applicants believe that the requested relief
from the Disclosure Requirements meets this standard because it will
improve the Adviser's ability to negotiate fees paid to the Sub-
Advisers that are more advantageous for the Subadvised Series.

    For the Commission, by the Division of Investment Management,
under delegated authority.
Eduardo A. Aleman,
Deputy Secretary.
[FR Doc. 2018-27516 Filed 12-19-18; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 83, Number 225 (Wednesday, November 21, 2018)]
[Notices]
[Pages 58767-58768]
[FR Doc No: 2018-25423]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OW-2015-0641; FRL-9986-92-OW]

Proposed Information Collection Request; Comment Request;
Information Collection Request for Reporting Requirements for BEACH Act
Grants (Renewal)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The Environmental Protection Agency (EPA) is planning to
submit an information collection request (ICR), ``Information
Collection Request for Reporting Requirements for BEACH Act Grants''
(EPA ICR No. 2048.06, OMB Control No. 2040-0244) to the Office of
Management and Budget (OMB) for review and approval in accordance with
the Paperwork Reduction Act. Before doing so, the EPA is soliciting
public comments on specific aspects of the proposed information
collection as described below. This is a proposed extension of the ICR,
which is currently approved through July 31, 2019. An Agency may not
conduct or sponsor and a person is not required to respond to a
collection of information unless it displays a currently valid OMB
control number.

DATES: Additional comments must be submitted on or before January 22,
2019.

ADDRESSES: Submit your comments, referencing Docket ID Number EPA-HQ-
OW-2015-0641 to the EPA (1) online using www.regulations.gov (our
preferred method), or (2) by mail to: EPA Docket Center, Environmental
Protection Agency, Mail Code 28221T, 1200 Pennsylvania Ave. NW,
Washington, DC 20460.
    The EPA's policy is that all comments received will be included in
the public docket without change including any personal information
provided, unless the comment includes profanity, threats, information
claimed to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute.

FOR FURTHER INFORMATION CONTACT: Tracy Bone, OW, 4305T, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460;
telephone number:<PHONE_NUMBER>; email address: [email protected].

SUPPLEMENTARY INFORMATION: Supporting documents which explain in detail
the information that the EPA will be collecting are available in the
public docket for this ICR. The docket can be viewed online at
www.regulations.gov

or in person at the EPA Docket Center, WJC West, Room 3334, 1301
Constitution Ave. NW, Washington, DC. The telephone number for the
Docket Center is<PHONE_NUMBER>. For additional information about the
EPA's public docket, visit http://www.epa.gov/dockets.
    Pursuant to section 3506(c)(2)(A) of the PRA, the EPA is soliciting
comments and information to enable it to: (i) Evaluate whether the
proposed collection of information is necessary for the proper
performance of the functions of the Agency, including whether the
information will have practical utility; (ii) evaluate the accuracy of
the Agency's estimate of the burden of the proposed collection of
information, including the validity of the methodology and assumptions
used; (iii) enhance the quality, utility, and clarity of the
information to be collected; and (iv) minimize the burden of the
collection of information on those who are to respond, including
through the use of appropriate automated electronic, mechanical, or
other technological collection techniques or other forms of information
technology, e.g., permitting electronic submission of responses. The
EPA will consider the comments received and amend the ICR as
appropriate. The final ICR package will then be submitted to OMB for
review and approval. At that time, the EPA will issue another Federal
Register notice to announce the submission of the ICR to OMB and the
opportunity to submit additional comments to OMB.
    Abstract: The Beaches Environmental Assessment and Coastal Health
(BEACH) Act amends the Clean Water Act (CWA) in part and authorizes the
U.S. Environmental Protection Agency (EPA) to award BEACH Act Program
Development and Implementation Grants to coastal and Great Lakes
states, tribes, and territories (collectively referred to as
jurisdictions) for their beach monitoring and notification programs.
The grants assist those jurisdictions to develop and implement a
consistent approach to monitor recreational water quality; assess,
manage, and communicate health risks from waterborne microbial
contamination; notify the public of pollution occurrences, and post
beach advisories and closures to prevent public exposure to microbial
pathogens. To qualify for a BEACH Act Grant, a jurisdiction must submit
information to the EPA documenting that its beach monitoring and
notification program is consistent with performance criteria outlined
in the National Beach Guidance and Required Performance Criteria for
Grants, 2014 Edition.
    Form numbers: None.
    Respondents/affected entities: Entities potentially affected by
this action are environmental and public health agencies in coastal and
Great Lakes states, territories, and tribes.
    Respondent's obligation to respond: Required to obtain the grants
as directed by the BEACH Act amendment to the CWA.
    Estimated number of respondents: 39.
    Frequency of response: Annual; however, the agency encourages more
frequent reporting to provide more up-to-date information to the
public.
    Total estimated burden: 88,569 hours (per year). Burden is defined
at 5 CFR 1320.03(b).
    Total estimated cost: $14,865,812 (per year), includes $11,063,780
(per year) operation & maintenance costs. There are no capital costs.
    Changes in estimates: There is a decrease of 2,707 hours in the
total respondent burden compared with the ICR approved by OMB in July
2015 due to the respondents no longer needing to prepare and submit
schedules for the adoption of new or revised WQS and identification and
use of a beach notification threshold (BNT). The EPA no longer requests
respondents submit these schedules because they are using BNTs or
alternate BNTs and have either adopted new or revised WQS or are in the
process of doing so. This decrease in hours is partially offset by one
additional tribe having qualified for a BEACH grant. The total
respondent cost decreased by $587,496. The decrease in cost is
partially offset by slight increases in the salary rates. The O&M
decreased by $289,366 due to a reduction in the total number of beaches
(affecting O&M). The number of beaches reported by the jurisdictions
varies from year to year for many reasons. Reasons for removing beaches
include the destruction of beaches by natural disasters, change in
beach ownership, and existing beaches being combined within a
jurisdiction's monitoring and notification program.

    Dated: November 13, 2018.
Deborah G. Nagle,
Acting Director, Office of Science and Technology.
[FR Doc. 2018-25423 Filed 11-20-18; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 77, Number 214 (Monday, November 5, 2012)]
[Notices]
[Pages 66461-66462]
[FR Doc No: 2012-26920]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RM98-1-000]

Records Governing Off-the-Record Communications; Public Notice

    This constitutes notice, in accordance with 18 CFR 385.2201(b), of
the receipt of prohibited and exempt off-the-record communications.
    Order No. 607 (64 FR 51222, September 22, 1999) requires Commission
decisional employees, who make or receive a prohibited or exempt off-
the-record communication relevant to the merits of a contested
proceeding, to deliver to the Secretary of the Commission, a copy of
the communication, if written, or a summary of the substance of any
oral communication.
    Prohibited communications are included in a public, non-decisional
file associated with, but not a part of, the decisional record of the
proceeding. Unless the Commission determines that the prohibited
communication and any responses thereto should become a part of the
decisional record, the prohibited off-the-record communication will not
be considered by the Commission in reaching its decision. Parties to a
proceeding may seek the opportunity to respond to any facts or
contentions made in a prohibited off-the-record communication, and may
request that the Commission place the prohibited communication and
responses thereto in the decisional record. The Commission will grant
such a request only when it determines that fairness so requires. Any
person identified below as

having made a prohibited off-the-record communication shall serve the
document on all parties listed on the official service list for the
applicable proceeding in accordance with Rule 2010, 18 CFR 385.2010.
    Exempt off-the-record communications are included in the decisional
record of the proceeding, unless the communication was with a
cooperating agency as described by 40 CFR 1501.6, made under 18 CFR
385.2201(e)(1)(v).
    The following is a list of off-the-record communications recently
received by the Secretary of the Commission. The communications listed
are grouped by docket numbers in ascending order. These filings are
available for review at the Commission in the Public Reference Room or
may 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, please contact FERC, Online Support at
<EMAIL_ADDRESS>or toll free at<PHONE_NUMBER>, or for TTY,
contact<PHONE_NUMBER>.

----------------------------------------------------------------------------------------------------------------
                 Docket No.                      Filed date                  Presenter or requester
----------------------------------------------------------------------------------------------------------------
                                                   Prohibited
----------------------------------------------------------------------------------------------------------------
1. CP11-72-000..............................          10-16-12  Carl Held.
2. CP11-161-000.............................          10-16-12  Thomas Klee.
3. CP11-161-000.............................          10-16-12  Pancho Antonetti.
4. CP11-161-000.............................          10-16-12  Samantha Antonetti.
5. CP11-161-000.............................          10-16-12  Gian Antonetti.
6. CP11-515-000.............................          10-18-12  Minisink Resident.\1\
7. CP11-515-000.............................          10-22-12  Janice Okeeffe.
                                                                Kevin M. Okeefe.
8. CP11-515-000.............................          10-22-12  Colin Okeeffe.
                                                                Lauren Okeeffe.
9. CP11-515-000.............................          10-22-12  Commission Staff.\2\
----------------------------------------------------------------------------------------------------------------
                                                     Exempt
----------------------------------------------------------------------------------------------------------------
1. CP08-431-000.............................          10-18-12  Hon. Sherrod Brown.
2. CP11-515-000.............................          10-22-12  U.S. Senators.\3\
3. CP12-495-000.............................          10-25-12  Gary Sorensen.
4. EL11-50-000..............................          10-22-12  Hon. Charles E. Schumer.
5. P-2100-000...............................          10-18-12  Hon. Wally Herger.
6. P-12690-000..............................          10-25-12  Catherine Creese.\4\
----------------------------------------------------------------------------------------------------------------
\1\ Protest card passed out at 10-18-12 Commission Meeting by a Minisink Resident.
\2\ Call log for 10-18-12, containing comments of Jessica Briecke and 14 others.
\3\ U.S. Senators Charles E. Schumer and Kirsten E. Gillibrand.
\4\ Email record.

    Dated: October 26, 2012.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2012-26920 Filed 11-2-12; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 85, Number 47 (Tuesday, March 10, 2020)]
[Notices]
[Page 13891]
[FR Doc No: 2020-04878]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 2088-068]

South Feather Water and Power Agency; Notice of Request for
Waiver Determination

    Take notice that on December 12, 2019, South Feather Water and
Power Agency, applicant for relicensing the South Feather Power Project
No. 2088, filed a letter requesting the Commission find that the
California State Water Resources Control Board waived its authority to
issue a certification for the South Feather Power Project under Section
401 of the Clean Water Act, 33 U.S.C. 1341(a)(1), as more fully
explained in the filing.
    Any person wishing to comment on South Feather Water Agency's
request may do so.\1\ The deadline for filing comments is 30 days from
the issuance of this notice. The Commission encourages electronic
submission of comments in lieu of paper using the ``eFiling'' link at
http://www.ferc.gov. Persons unable to file electronically should send
comments to the following address: Federal Energy Regulatory
Commission, 888 First Street NE, Washington, DC 20426. Be sure to
reference the project docket number (P-2088-068) with your submission.
---------------------------------------------------------------------------

    \1\ South Feather Water and Power Agency's request is part of
its relicensing proceeding in Project No. 2088-068. Thus, any person
that intervened in the relicensing proceeding is already a party.
The filing of the request does not trigger a new opportunity to
intervene.
---------------------------------------------------------------------------

    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 website that enables subscribers to receive email
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5:00 p.m. Eastern Time on April 3, 2020.

    Dated: March 4, 2020.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2020-04878 Filed 3-9-20; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 80, Number 193 (Tuesday, October 6, 2015)]
[Notices]
[Page 60397]
[FR Doc No: 2015-25302]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID: FEMA-2015-0019; OMB No. 1660-0108]

Agency Information Collection Activities: Proposed Collection;
Comment Request; National Emergency Family Registry and Locator System

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: The Federal Emergency Management Agency, as part of its
continuing effort to reduce paperwork and respondent burden, invites
the general public and other Federal agencies to take this opportunity
to comment on an extension of a currently approved information
collection. In accordance with the Paperwork Reduction Act of 1995,
this notice seeks comments concerning the FEMA National Emergency
Family Registry and Locator System (NEFRLS), which allows adults that
have been displaced by a Presidentially declared disaster or emergency
to reunify with their families.

DATES: Comments must be submitted on or before December 7, 2015.

ADDRESSES: To avoid duplicate submissions to the docket, please use
only one of the following means to submit comments:
    (1) Online. Submit comments at www.regulations.gov under Docket ID
FEMA-2015-0019. Follow the instructions for submitting comments.
    (2) Mail. Submit written comments to Docket Manager, Office of
Chief Counsel, DHS/FEMA, 500 C Street SW., 8NE, Washington, DC 20472-
3100.
    All submissions received must include the agency name and Docket
ID. Regardless of the method used for submitting comments or material,
all submissions will be posted, without change, to the Federal
eRulemaking Portal at http://www.regulations.gov, and will include any
personal information you provide. Therefore, submitting this
information makes it public. You may wish to read the Privacy Act
notice that is available via the link in the footer of
www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Michael Lee, Program Specialist,
Recovery Directorate, Individual Assistance Division, Mass Care/
Emergency Management Section at<PHONE_NUMBER>. You may contact the
Records Management Division for copies of the proposed collection of
information at email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The Post-Katrina Emergency Management Reform
Act of 2006 (PKEMRA), in Title VI of the DHS Appropriations Act of
2007, Public Law 109-295, Section 689c, 120 Stat. 1355 at 1451 is the
legal basis for FEMA to provide a National Emergency Family Registry
and Locator System (NEFRLS). NEFRLS allows adults (including medical
patients), displaced by a Presidentially declared major disaster or
emergency, to voluntarily register by submitting personal information
into a database that can be used by others to help reunify them with
their families. Children who are traveling with their families during a
Presidentially declared major disaster or emergency can be listed in
NEFRLS. NEFRLS allows a registrant to designate up to 7 individuals who
are authorized to search for and access the registrant's information in
the system. The ability to list children within NEFRLS is only to
indicate which family members are together and safe.

Collection of Information

    Title: National Emergency Family Registry and Locator System
(NEFRLS).
    Type of Information Collection: Revision of a currently approved
information collection.
    OMB Number: 1660-0108.
    FEMA Forms: FEMA Form 528-1.
    Abstract: NEFRLS is a Web-based database enabling FEMA to provide a
nationally available and recognized database allowing adults (including
medical patients) that have been displaced by a Presidentially declared
major disaster or emergency to voluntarily register via the Internet or
a toll-free number. This database allows designated individuals to
search for displaced friends, family, and household members. Congress
mandated that FEMA establish NEFRLS in the PKEMRA section 689c.
    Affected Public: State, Local or Tribal Government, Federal
Government, and Individuals or Households.
    Number of Respondents: 56,000.
    Number of Responses: 56,000; NEFRLS Tele-registration: 14,000 and
NEFRLS Internet Registration: 42,000.
    Estimated Total Annual Burden Hours: 10,640.
    Estimated Cost: $241,634. There are no recordkeeping, capital,
start-up or maintenance costs associated with this information
collection.

Comments

    Comments may be submitted as indicated in the ADDRESSES caption
above. Comments are solicited to (a) evaluate whether the proposed data
collection is necessary for the proper performance of the agency,
including whether the information shall have practical utility; (b)
evaluate the accuracy of the agency's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (c) enhance the quality, utility, and
clarity of the information to be collected; and (d) minimize the burden
of the collection of information on those who are to respond, including
through the use of appropriate automated, electronic, mechanical, or
other technological collection techniques or other forms of information
technology, e.g., permitting electronic submission of responses.

    Dated: September 30, 2015.
Richard W. Mattison,
Records Management Program Chief, Mission Support, Federal Emergency
Management Agency, Department of Homeland Security.
[FR Doc. 2015-25302 Filed 10-5-15; 8:45 am]
 BILLING CODE 9111-23-P


[Federal Register Volume 87, Number 15 (Monday, January 24, 2022)]
[Rules and Regulations]
[Page 3449]
[FR Doc No: 2022-01247]

=======================================================================
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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

46 CFR Parts 114, 116, 118, 122, 175, 177, 181, and 185

[Docket No. USCG-2021-0306]
RIN 1625-AC69

Fire Safety of Small Passenger Vessels; Correction

AGENCY: Coast Guard, DHS.

ACTION: Interim rule; correction.

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

SUMMARY: The Coast Guard is correcting an interim rule that appeared in
the Federal Register on December 27, 2021. The interim rule announced
changes to small passenger vessel fire safety regulations. The interim
rule has an effective date of March 28, 2022. This correction fixes
incorrect cross references in the regulatory text of that interim rule.

DATES: This correction is effective on March 28, 2022.

FOR FURTHER INFORMATION CONTACT: If you have questions on this
correction, please contact Lieutenant Carmine Faul, Coast Guard;
telephone<PHONE_NUMBER>, email [email protected].

SUPPLEMENTARY INFORMATION:

Correction

    In FR Doc. 2021-27549, published at 86 FR 73160 on December 27,
2021, the Coast Guard is correcting incorrect cross references in the
regulatory text of Sec.  114.110(g)(1). On page 73171, published in the
first column, the interim rule referenced incorrect paragraphs in the
second amendatory instruction for Sec.  114.110(g)(1). There, the
interim rule incorrectly referenced the requirements in Sec. Sec.
118.400(c) and 118.500r. We are correcting the interim rule to instead
cross reference Sec. Sec.  118.400(d) and 118.500 in Sec.
114.110(g)(1). The interim rule added new Sec.  118.400(d) which
requires certain small passenger vessels to install an interconnected
fire detection system. Referencing paragraph (c) of Sec.  118.400 was a
typographical error. Additionally, Sec.  118.500r does not exist. The
``r'' is a typographical error.
    In FR Doc. 2021-27549, appearing on page 73171 in the Federal
Register of Monday, December 27, 2021, the following correction is
made:

Sec.  114.110   [Corrected]

0
1. On page 73171, in the first column, in part 114, in amendment 2, in
the regulatory text of Sec.  114.110(g)(1), the text ``118.400(c) and
118.500r'' is corrected to read ``118.400(d) and 118.500''.

    Dated: January 19, 2022.
M.T. Cunningham,
Chief, Office of Regulations and Administrative Law.
[FR Doc. 2022-01247 Filed 1-21-22; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 76, Number 201 (Tuesday, October 18, 2011)]
[Notices]
[Pages 64340-64341]
[FR Doc No: 2011-26861]

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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
rate filings:

    Docket Numbers: ER11-4042-001.
    Applicants: The Detroit Edison Company.
    Description: The Detroit Edison Company submits tariff filing per
35: FERC Electric Rate Schedule No. 43--SFA Compliance Filing to be
effective 9/28/2011.
    Filed Date: 10/05/2011.
    Accession Number: 20111005-5038.
    Comment Date: 5 p.m. Eastern Time on Wednesday, October 26, 2011.

    Docket Numbers: ER11-4469-001.
    Applicants: Columbia Utilities Power, LLC.
    Description: Columbia Utilities Power, LLC submits tariff filing
per 35: Columbia Utilities Power FERC Electric Tariff to be effective
9/8/2011.
    Filed Date: 10/05/2011.
    Accession Number: 20111005-5029.
    Comment Date: 5 p.m. Eastern Time on Wednesday, October 26, 2011.

    Docket Numbers: ER12-23-000.
    Applicants: Sierra Pacific Power Company.
    Description: Sierra Pacific Power Company submits tariff filing per
35.13(a)(2)(i): Rate Schedule No. 27--Annual BPA-GTA Update 2011 to be
effective 11/1/2011.
    Filed Date: 10/05/2011.
    Accession Number: 20111005-5000.
    Comment Date: 5 p.m. Eastern Time on Wednesday, October 26, 2011.

    Docket Numbers: ER12-25-000.
    Applicants: Southwest Power Pool, Inc.
    Description: Southwest Power Pool, Inc. submits tariff filing per
35.13(a)(2)(iii: Implement Formula Rate Updates for GRDA, LES and OPPD
to be effective 8/1/2011.
    Filed Date: 10/05/2011.
    Accession Number: 20111005-5019.
    Comment Date: 5 p.m. Eastern Time on Wednesday, October 26, 2011.

    Docket Numbers: ER12-26-000.
    Applicants: New York Independent System Operator, Inc.
    Description: New York Independent System Operator, Inc. submits
tariff filing per 35.13(a)(2)(iii: NYISO proposed tariff revisions
regarding dispute resolution provisions to be effective 12/4/2011.
    Filed Date: 10/05/2011.
    Accession Number: 20111005-5048.
    Comment Date: 5 p.m. Eastern Time on Wednesday, October 26, 2011.

    Docket Numbers: ER12-27-000.
    Applicants: New York Independent System Operator, Inc.
    Description: New York Independent System Operator, Inc. submits
tariff filing per 35.13(a)(2)(iii: NYISO proposed ISO Agreement
revisions regarding dispute resolution provisions to be effective 12/4/
2011.
    Filed Date: 10/05/2011.
    Accession Number: 20111005-5052.
    Comment Date: 5 p.m. Eastern Time on Wednesday, October 26, 2011.

    Docket Numbers: ER12-28-000.
    Applicants: Southwest Power Pool, Inc.
    Description: Southwest Power Pool, Inc. submits tariff filing per
35.13(a)(2)(iii: Implement Formula Rate Updates for Midwest Energy,
Inc. to be effective 9/1/2011.
    Filed Date: 10/05/2011.
    Accession Number: 20111005-5068.
    Comment Date: 5 p.m. Eastern Time on Wednesday, October 26, 2011.

    Docket Numbers: ER12-29-000.
    Applicants: PPL EnergyPlus, LLC.
    Description: PPL EnergyPlus, LLC submits tariff filing per 35: PPL
EnergyPlus Compliance Tariff to be Effective March 1, 2010 to be
effective 9/30/2010.
    Filed Date: 10/05/2011.
    Accession Number: 20111005-5070.
    Comment Date: 5 p.m. Eastern Time on Wednesday, October 26, 2011.

    Docket Numbers: ER12-30-000.
    Applicants: BlueStar Energy Services Inc.
    Description: BlueStar Energy Services Inc. submits tariff filing
per 35.1: Baseline FERC Electric MBR Tariff Filing to be effective 10/
5/2011.
    Filed Date: 10/05/2011.
    Accession Number: 20111005-5075.
    Comment Date: 5 p.m. Eastern Time on Wednesday, October 26, 2011.

    Docket Numbers: ER12-31-000.
    Applicants: Southern California Edison Company.
    Description: Southern California Edison Company submits tariff
filing per 35.13(a)(2)(iii: SGIA WDT SERV SCE-SunEdison 1351 Railroad
Ave. Corona Roof Top Solar Project to be effective 10/6/2011.
    Filed Date: 10/05/2011.
    Accession Number: 20111005-5082.
    Comment Date: 5 p.m. Eastern Time on Wednesday, October 26, 2011.

    Docket Numbers: ER12-32-000.
    Applicants: Silver State Solar Power North, LLC.
    Description: Silver State Solar Power North, LLC submits tariff
filing per 35.12: Silver State North Initial Market-Based Rate Tariff
to be effective 11/15/2011.
    Filed Date: 10/05/2011.
    Accession Number: 20111005-5092.
    Comment Date: 5 p.m. Eastern Time on Wednesday, October 26, 2011.

    Docket Numbers: ER12-33-000.
    Applicants: Duke Energy Ohio, Inc., Duke Energy Kentucky, Inc.,
Midwest Independent Transmission System Operator, Inc.
    Description: Duke Energy Ohio, Inc. submits tariff filing per
35.13(a)(2)(iii: 10-05-11 DEO/DEK Exit Fee Agreement to be effective
12/31/2011.
    Filed Date: 10/05/2011.
    Accession Number: 20111005-5093.
    Comment Date: 5 p.m. Eastern Time on Wednesday, October 26, 2011.

    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
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: October 6, 2011.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2011-26861 Filed 10-17-11; 8:45 am]
BILLING CODE 6717-01-P


1 Bollgard and Bollgard II Cotton Bollworm Resistance Management Issues Sharlene R. Matten, Ph. D., Biologist USEPA/ OPP Biopesticides and Pollution Prevention Division Matten. sharlene@ epa. gov 703 605 0514 Bollgard and Bollgard II Cotton Bollworm Resistance Management Issues Sharlene R. Matten, Ph. D., Biologist USEPA/ OPP Biopesticides and Pollution Prevention Division Matten. sharlene@ epa. gov 703 605 0514 2 Purpose  Highlight EPA's assessment of the Helicoverpa zea ( cotton bollworm, CBW) insect resistance management ( IRM) data submitted by Monsanto required as part of the terms and conditions of the Bollgard and Bollgard II registrations  Bollgard expresses moderate dose of Cry1Ac against CBW  CBW resistance risk considered the greatest  5% external, unsprayed, structured refuge option poses greatest concern; option expires Sept. 30, 2004  Specific data requirements

North south movement

Pyrethroid oversprays

Alternative hosts

Bollgard and Bollgard II registrations expire Sept. 2006 3 EPA Decision  EPA will determine whether the scientific data are adequate to support continuation of the 5%

external, unsprayed, structured refuge for CBW resistance management after Sept. 30, 2004. 4 Outline  Current IRM refuge requirements  Major issues for SAP  North south movement  Synthetic pyrethroid oversprays  Alternative hosts as natural refugia  Gustafson et al. CBW resistance management model  Overall conclusion  SAP questions 5 Current IRM Requirements

5% external, unsprayed refuge: > 150 ft. wide (> 300ft. preferred), < 1/ 2 mile ( 1/ 4 mile or adjacent preferred), expires 9/ 30/ 04

20% external, sprayed refuge: < 1 mile ( 1/ 2 mile or closer preferred) 7 Acres 7 Acres 50 Acres 50 Acres 10 Acres 10 Acres 20 Acres 20 Acres 20 Acres 20 Acres 20 Acres 20 Acres 45 Acres 45 Acres 5% Untreated Refuge with Distance Requirement 5% Untreated Refuge with Distance Requirement 75 Acres 75 Acres Refuge Refuge Refuge Refuge 30 Acres 30 Acres 50 Acres 50 Acres < 0.5 Mile < 0.5 Mile < 0.5 Mile < 0.5 Mile <

0.5 Mile <

0.5 Mile < 0.5 Mile < 0 .5 Mile < 0.5 Mile < 0.5 Mile < 0.5 Mile < 0.5 Mile < 0.5 Mile < 0.5 Mile <

0.5 Mile <

0.5 Mile Road Road **********

***********

Refuge Field *********** *********** **********

***********

Refuge Field *********** *********** One mile or less On e mile or less 20% Sprayed Refuge with Distance Requirement 20% Sprayed Refuge with Distance Requirement Bollgard Bollgard Bollgard Bollgard Bollgard Bollgard Bollgard Bollgard Bollgard Bollgard Bollgard Bollgard Bollgard Bollgard Bollgard Bollgard Bollgard Bollgard ( 20%) Sprayed ( 20%) Sprayed 6 Current IRM Requirements

5% embedded refuge: > 150 ft.

wide (> 300ft. preferred), refuge can only be treated if entire field treated

5% embedded refuge for PBW:

embedded refuge must be at least 1 non Bt cotton row for every 6 10 rows of Bt cotton.

Community refuge: use either 5%

external, unsprayed and/ or 20%

external, sprayed refuge A= 20 A= 20 5% Embedded Refuge ( Field Unit)

5% Embedded Refuge ( Field Unit)

One Mile One Mile One Mile One Mile Field Road Field Road 50 Acres Bollgard 50 Acres Bollgard 100 Acres Bollgard 100 Acres Bollgard 50 Acres Bollgard 50 Acres Bollgard 40 Acres Bollgard 40 Acres Bollgard 40 Acres Bollgard 40 Acres Bollgard 100 Acres Bollgard 100 Acres Bollgard 10 Acre Refuge 10 Acre Refuge 10 Acre Refuge 10 Acre Refuge 400 Total Acres 5% = 20 Total Refuge Acres Needed 400 Total Acres 5% = 20 Total Refuge Acres Needed A= 7 A= 7 B= 50 B= 50 C= 10 C= 10 A= 20 A= 20 A= 20 A= 20 A= 20 A= 20 B= 45 B= 45 Community Refuge Plan  20% Sprayed Community Refuge Plan  20% Sprayed Grower A = 117A Grower A = 117A Grower B = 125A Grower B = 125A Grower C = 85A Grower C = 85A 327A 327A Refuge = 20%

Refuge = 20%

65.4 Acres Needed 65.4 Acres Needed C= 75 C= 75 B= 30 B= 30 A= 50 A= 50 Road Road 20% Sprayed Refuge 20% Sprayed Refuge **********

*********** *********** **********

*********** ***********

******************** One Mile 7 Bollgard and Bollgard II CBW IRM Issues: Focal Points for SAP

North south movement. Evaluate reverse migration impact on CBW adaptation to Bt crops.

Pyrethroid oversprays. Evaluate impact of pyrethroid oversprays on CBW survivors in Bollgard fields and the effect on resistance management.

Alternative hosts. Evaluate the effectiveness of alternative hosts as natural refuges in comparison to the 5% external, unsprayed structured refuge

Gustafson et al. model. Evaluate impact of pyrethroid oversprays and alternative hosts on resistance evolution. 8 North South ( N S) Movement  CEW/ CBW adults move from corn to cotton over the course of the season.

 Feed on both Bt corn and Bt cotton  May undergo selection for adaptation to Bt toxins for several generations each year. 9 N S Movement

Previously thought there was only " one way" CBW migration

Gould et al. 2002

Indirect evidence for reverse migration ( Bossier Parish, LA and College Station, TX)   50 60%

CBW migrating from the North

Timing and extent of reverse migration appears to vary considerably from year to year

Postulated high Bt corn deployment could impact CBW resistance evolution to Bt cotton 10 N S Movement  Modeling

Storer et al.' s spatially explicit, stochastic CBW model ( Storer et al., 2003) was adapted to incorporate southnorth migration in the spring and north south migration in the summer.

Quantify how migration may impact adaptation rates under a range of different circumstances.

Two models were run in parallel for the summer generations:

cotton growing region

corn growing region. 11 N S Movement   Modeling Assumptions  Corn, cotton and soybean are crop hosts for CBW;

Weed hosts are available at the start of the season and end of the season;

Complete cross resistance among the three Cry1 toxins ( Cry1Ab, Cry1Ac, Cry1F);

Additive functional dominance of allele for adaptation ( h = 0.5);

Migration occurs pre mating ( as indicated by field studies on mating and flight behavior in Helicoverpa spp.); and

Migration occurs to the same extent every year. 12 N S Movement   Model Output  Model output was the resistance ( r) allele frequency after 15 years of deploying Bt corn and Bt cotton 13 N S Movement   Modeling Results

Two parameters increased the r allele frequency after 15 years

Increasing the percentage of Bt corn ( BtcrS)

Increasing the percentage of Bt cotton ( Btct)

Magnitude of significant effects or interactions ln( Q+ 15/ Q0)/ ln( Q 15/ Q0)  1

Q+ 15 = r allele frequency after 15 years with reverse migration

Q0 = initial r allele frequency

Q 15 = r allele frequency after 15 years without reverse migration 14 Impact of Reverse Migration on Adaptation Rate  Modeling Impact of reverse migration on adaptation rate after 15 years Bt Cotton Bt Corn Increase 10%

60%

80%

Extreme Conditions   Selection is greatest in the North,

Lowest in the South ( i. e.,

50% return migration,

75% survival of N S migrants) Increase 2%

60%

80%

High Bt Corn Slow 4%

60%

30%

Current Deployment Levels 15 N S Movement Study Conclusion  Based on the modeling studies submitted using the data in Gould et al. ( 2002), CBW ( also called corn earworm in corn) reverse migration has no significant impact ( 0.05< P) on CBW adaptation to Bt corn and cotton. 16 Pyrethroid Overspray Studies  Field studies: NC, LA, MS, SC ( Natural infestations)

 Laboratory studies: CBW survivor susceptibility  Purpose: Determine the impact of pyrethroid oversprays on CBW control in Bollgard fields and evolution of resistance. 17 North Carolina Field Studies   2001 02 North Carolina Bollgard Non Bollgard 78.2 93.7 Adults 73.8 92.1 Pupae 62.1 89.3 Large larvae Jackson et al., 2003b 2002 72.1 77.5 % Damaged Bolls 70.4 87.9 % Damaged Squares 69.7 86.7 % Infested Bolls 80.5 92.3 % Infested Squares Jackson et al., 2003a 2001 02 % Reduction Due to Spray What was measured Study and Year Conducted 18 LA and MS Field Studies   2001 02 Mississippi Louisiana 55.4 58.3 % Damaged Bolls 47.9 59.8 Mean # Larvae per Sample*  9.4 70.0 Mean # Larvae per 25 plants Harris et al., 2002 2001 40.4 63.6 % Infested Bolls Leonard, 2003 2002 Non Bollgard Bollgard % Reduction Due to Spray What was measured Study and Year 19 South Carolina   1999 Field Study Irrigated* 83.1 58.5 0.015 93.1 87.1 0.028 Brickle et al.,

2001 71.9 85.7 0.015 86.4 94.7 0.028 Brickle et al.,

2001 Non irrigated Non Bollgard Bollgard % Reduction Due to Spray Application Rate ( kg ai/ ha)

Study * Excessive soil moisture or vegetative growth or intrinsic differences in Bt expression 20 Pyrethroid Oversprays for CBW in Bollgard vs. Non Bollgard Fields: Conclusions  Field studies NC, MS, LA, SC ( non irrigated)

show pyrethroid oversprays are more effective in Bollgard fields than non Bollgard fields.

 Percent insecticide control values and total number of adults ( insecticide treated vs.

nontreated can be used to develop reliable parameters for mathematical models. 21 Pyrethroid Oversprays for CBW in Bollgard II Fields: Conclusions  Percentage squares and bolls infested and percentage damaged squares and bolls were not statistically different in Bollgard treated and Bollgard II untreated and treated plots.

 Results from North Carolina and Mississippi field studies suggest that pyrethroid oversprays will likely not be necessary for CBW in Bollgard II cotton fields as they were for Bollgard cotton fields 22 Bollworm Survivor Susceptibility: NC 2003 0.069 0.191 0.150 F2 Bollgard 0.137 0.217 0.179 F2 Non Bollgard 12.8 19.6 15.6 F2 Bollgard 25.5 37.9 30.6*

F1 Bollgard Bollgard Non Bollgard Non Bollgard Non Bollgard Cotton Type Cypermethrin ( technical grade)

Cry1Ac 7.41 27.9 13.2 F2 0.528 2.82 0.806 F1 0.504 0.819 0.623 F1 12.3 21.8 16.3 F1 Lower Upper 95% Confidence Limits LC 50 ( mg/ ml)

Generation ( Marcus et al. 2004) 23 Laboratory Study Bollworm Susceptibility Conclusions  Tolerance in Cry1Ac in the F1 generation was not statistically significant and may not truly exist  No difference in susceptibility to pyrethroids  Authors are working to select for a CBW strain that has very high levels of Cry1Ac resistance to provide more rigorous results 24 Pyrethroid Overspray Studies: Overall Conclusions  Pyrethroid oversprays in Bollgard cotton fields will increase the level of control of CBW and delay the evolution of resistance.

 Findings can be used to develop reliable parameters in mathematical models  Pyrethroid oversprays for Bollgard II cotton   no significant difference  Laboratory studies have not uncovered a reason for the fitness difference ( Bollgard vs. non Bollgard). 25 Alternative Host Studies  In 2001, EPA required that alternative host data be generated.

 Purpose: Demonstrate whether CBW alternative hosts provide a large and effective unstructured refuge for Bollgard and Bollgard II cotton in the U. S to allow continuation of the 5% external,

unsprayed structured refuge option. 26 Outline of Alternative Hosts Studies

Two year study ( 2002 2003) conducted in LA, AR, MS, GA, NC

100 sampling locations: Bollgard cotton field and an adjacent alternate host crop

Bollgard: corn, soybean, sorghum ( MS, LA, AR  mid South locations)

Bollgard: peanuts ( NC, GA  Southeast locations)

Bollgard: non Bollgard

Bollgard cotton: Bollgard cotton

Larval productivity

Adult productivity: pheromone traps

C3/ C4 carbon isotope analyses: crop source of adults

Assessment of the spatial and temporal distribution of alternative hosts using satellite imaging and USDA/ NASS ( 2002) database 27 Literature Review ( Benedict, 2004)

 Comprehensive review of biology and ecology of TBW and CBW  CBW  Sections: alternative hosts, sequential host utilization, larval and adult productivity on each host, movement and dispersal properties, gene flow  130 crop and non crop hosts; typically 4 generations; ability to move amongst hosts > 10 mi; little genetic variation  Identify corn, peanuts, sorghum, and soybeans as alternative hosts for CBW  Few, if any, studies that have determined the numbers of adult heliothines produced per acre by any host plant and determined the number of adults produced per acre by all host plant species for a crop production system  Field studies designed to prove whether alternative hosts provide a large and effective unstructured CBW refuge 28 Cropping Pattern Analysis

Corn, peanuts, sorghum,

and soybeans present over substantial areas in all of the major cotton growing areas at all spatial scales examined ( 1 mile, 10 mile)

Data from USDA/ NASS,

2002

Acreages remained stable from 1995 2002 in each state or county 1a. Arkansas cropping patterns 0 40000 80000 120000 160000 1995 1997 1999 2001 Cumulative acreage Soybean Sorghum Corn Cotton 1d. Georgia cropping patterns 0 20000 40000 60000 80000 1995 1996 1997 1998 1999 2000 2001 2002 Cumulative acreage Tobacco Soybean Sorghum Peanuts Corn Cotton 1b. Louisiana cropping patterns 0 45000 90000 135000 180000 1995 1997 1999 2001 Cumulative acreage Soybean Sorghum Corn Cotton 1c. Mississippi cropping patterns 0 60000 120000 180000 240000 1995 1997 1999 2001 Cumulative acreage Soybean Sorghum Corn Cotton 1e. North Carolina cropping patterns 0 25000 50000 75000 100000 1995 1996 1997 1998 1999 2000 2001 2002 Cumulative acreage Tobacco Soybean Sorghum Peanuts Corn Cotton Tobacco Soybean Sorghum Peanuts Corn Cotton ( Head and Voth, 2004) 29 Larval Productivity Studies  Larval distributions over time in five states in 2002 and 2003  Larval surveys used to measure productivity on each host and predict when relevant crop fields will produce CBW adults and  Time to adult emergence is approx. 14 days  Adult lifespan is approx. 7 days 30 3a. Larval abundance in Arkansas 2003 0 1 2 3 6/ 2 6/ 16 6/ 30 7/ 14 7/ 28 8/ 11 8/ 25 9/ 8 Abundance Cor n Cotton Sor ghum Soybean 3d. Larval abundance in Georgia 2003 0 1 2 3 6/ 2 6/ 16 6/ 30 7/ 14 7/ 28 8/ 11 8/ 25 9/ 8 Abundance Cor n Cotton Peanut Soybean 3b. Larval abundance in Louisiana 2003 0 1 2 3 6/ 2 6/ 16 6/ 30 7/ 14 7/ 28 8/ 11 8/ 25 9/ 8 Abundance Cor n Cotton Sor ghum Soybean 3c. Larval abundance in Mississippi 2003 0 1 2 3 6/ 2 6/ 16 6/ 30 7/ 14 7/ 28 8/ 11 8/ 25 9/ 8 Abundance Cor n Cotton Sor ghum Soybean 3e. Larval abundance in North Carolina 2003 0 1 2 3 6/ 2 6/ 16 6/ 30 7/ 14 7/ 28 8/ 11 8/ 25 9/ 8 Abundance Cor n Cotton Peanut Soybean Larval Productivity  2003 Index: 1 = 20 200 larvae/ acre; 2 = 200 2000 larvae/ acre; 3 =

> 2000 larvae/ acre ( and generally > 10,000).

( Head and Voth, 2004) 1. Order: corn>>> sorghum> cotton ( peanuts) > soybean 2. NC: Populations are synchronous Corn Sorghum ( AR, LA, MS)

Cotton Soybean Peanut ( GA, NC) 31 Larval Productivity Studies  Conclusions

Larval populations were high on the alternative host crops and were equal to or greater than populations on cotton

Phenology of these populations overlapped with those populations in cotton (= Synchrony of production).

Predict CBW adults in corn by mid June and dominate the landscape until early August

Later adult generations are predicted to dominate in mid August on sorghum, cotton, peanuts, and soybeans ( depending on the region)

Difficult to predict adult productivity from larval productivity studies 32 Adult Productivity Studies   Pheromone Trapping Data in 2002 03  Comparable numbers of adult CBW were captured at all the different crop interfaces in a given state  Adults moving broadly across the landscape  No statistical differences except for a few early season samples in Arkansas and a few other sporadic cases  In 2003, 30 out of 878 pairs of means ( 3.4%) were statistically significant at the 95% confidence level 33 Carbon Isotope Analysis: Sources of Adult Moths ( Semi quantitative)

 Distinguish moths that feed on C3 hosts ( soybean, cotton,

peanuts) from C4 hosts ( corn, sorghum) ( method described in Gould et al., 2002).

 Moths that feed on C3 hosts will have a different 13C to 12C ratio than moths that feed on C4 hosts based on carbon assimilation physiology of the host plant.

Wings from up to 100 adults from a given trapping location and date were pooled

Percentage of C4 plants was calculated by comparing the value obtained to a standard curve

ANOVA run on % moths from C4 plants and pair wise comparisons were performed for each state and week in both 2002 and 2003 34 Fig. 5. Percentage of C4 Adults by State in 2003 0 20 40 60 80 100 5/ 19 6/ 9 6/ 30 7/ 21 8/ 11 9/ 1 9/ 22 10/ 13 %

C4 Arkansas Georgia Louisiana Mississippi North Carolina Sources of Adult Moths:

Percentage of C4 Adults by State ( Head and Voth, 2004)

0 20 40 60 80 100 5/ 19 6/ 9 6/ 30 7/ 21 8/ 11 9/ 1 9/ 22 10/ 13 %

C4 C4 alternative hosts C3 hosts other than cotton C3 hosts including cotton,

soybeans and peanuts 35 Sources of Moths: Conclusions

Total adult production from C4 alternative host of CBW,

averaged across all states, is at least 20% and reaches a peak of 80 100% from early July through the end of August.

Exact source and proximity of these alternative hosts cannot be determined from the data.

Source of late season CBW adults may be southern migrants from the Midwest corn belt ( Gould et al.,

2002). Findings of Head and Voth ( 2004) are the same as Gould et al. ( 2002). 36 7a. % C4 in Arkansas 2002 0 20 40 60 80 100 6/ 3 6/ 17 7/ 1 7/ 15 7/ 29 8/ 12 8/ 26 9/ 9 %

C4 Obser ved County 10 mi le 1 mil e 7b. % C4 in Louisiana 2002 0 20 40 60 80 100 6/ 10 6/ 24 7/ 8 7/ 22 8/ 5 8/ 19 9/ 2 9/ 16 %

C4 Obser ved County 10 mi le 1 mi l e 7e. % C4 in North Carolina 2002 0 20 40 60 80 100 6/ 17 7/ 1 7/ 15 7/ 29 8/ 12 8/ 26 9/ 9 %

C4 Obser ved County 10 mi le 1 mi l e 7c. % C4 in Mississippi 2002 0 20 40 60 80 100 6/ 24 7/ 8 7/ 22 8/ 5 8/ 19 9/ 2 9/ 16 %

C4 Obser ved County 10 mi le 1 mi le 7d. % C4 in Georgia 2002 0 20 40 60 80 100 6/ 24 7/ 8 7/ 22 8/ 5 8/ 19 9/ 2 %

C4 Obser ved County Observed and Predicted Percentage of CBW Moths from C4 Hosts at Different Spatial Scales ° Predicted curves: satellite imaging for 1 mi and 10

mi; USDA/ NASS for county level at 10 mi scale and larval abundances translated to adult emergence ° Predicted underestimate the importance of C4 contribution.

° Scale of adult CBW movement is > 10 miles Observed County 10 mile 1 mile * 37 CBW Alternative Hosts Studies   Specific Conclusions  Based on carbon isotope analyses, both C3 and C4 alternative hosts serve as unstructured refugia throughout the growing season and throughout the landscape.

 Alternative hosts contribute greater numbers of CBW moths than the local 5% external,

unsprayed structured non Bt cotton refuge.

 C4 alternative hosts contribute 20 95% of the CBW moths in and around cotton fields throughout the growing season. 38 CBW Alternative Hosts Studies   Specific Conclusions  Corn is the greatest producer of CBW adults in the early season; while, sorghum, peanuts,

soybeans, and cotton are producers of CBW adults in the later generations.

 CBW adults are dispersing long distances (> 10 miles) in search of suitable oviposition and feeding sites. 39 CBW Alternative Hosts Studies   Overall Conclusions

CBW moths are produced on alternative hosts in sufficient numbers throughout the cotton growing season to mate with any putative resistant CBW moths emerging in Bollgard or Bollgard II cotton fields and dilute resistance.

Susceptible CBW moths coming from alternative hosts ( immigrants) will reduce the intensity of Cry1Ac and Cry2Ab2 resistance selection in CBW and lower the likelihood of resistance evolution.

Results of the alternative host studies support the continuation of the 5% external, unsprayed structured non Bt cotton refuge. 40 Gustafson et al. ( 2001) CBW Model*

 Modified Caprio's ( 1998a) ILSI two patch,

deterministic, non random, population genetics model  Included insecticidal oversprays of Bollgard cotton fields and the utilization of alternative hosts as natural refugia as parameters  * Same study submitted in 2001 and 2004. 41 Gustafson et al. ( 2001) CBW model   " Effective Refuge Size"

 Calculated by county  Total acres of non Bt cotton, Bt cotton, soybean,

alfalfa, sorghum ( USDA/ NASS, 1999)

 Wild and weedy plants = 10% ( Caprio and Benedict, 1996)

 Corn not included  Effective refuge size: 43 100% 42 Gustafson et al. ( 2001) CBW Model  Model output: number of generations until the rallele frequency exceeds 0.5  Marginal sensitivity analysis: one parameter alone was varied while all other parameters were held at the " mid" value 43 Gustafson et al., ( 2001) CBW Model:

Sensitivity Analysis Results 86 86 47 > 5000 84 68 42 47 High 91 91 85 147 86 86 92 90 Mid 26 26 26 36 25 25 26 27 Mid 27 26 36 13 25 26 > 5000 > 5000 Low CBW M R q ( t 0)

P rr Sr Sr SS 101 25 Move outside habitat before ovipositing 101 25 Move outside habitat before mating 127 16 Resistance Allele Initial Frequency* 25 553 Refuge* 89 25 123 24 Survival on Conventional Cotton > 5000 15 > 5000 15 Survival on Bollgard Cotton Low High Parameter CBW Sprayed* 44 Gustafson et al. ( 2001) CBW Model Results CBW Untreated BG CBW Treated BG Impact of effective refuge size and pyrethroid oversprays on model results using " mid" parameter values 45 Gustafson et al. ( 2001) CBW Model   Issues with " Effective Refuge Size"

 Monsanto's calculation assumes that all hosts are equally productive and synchronous, as well as are generation independent.

 EPA disagrees with Monsanto's assumptions. Same type of calculation used in Head and Voth ( 2004).

 There is no sequential host utilization by generation.

 Different generations will feed on different hosts.

 Larval and moth production on each host varies considerably.

 Corn not included in 2001. 46 Gustafson et al. ( 2001) CBW Model   Issues with " Effective Refuge Size"

 EPA recommends that the " effective refuge size"

be a weighted average of the proportion of moths coming from each alternative host for each CBW generation ( 4 to 6 generations) in each cotton production system. 47 Gustafson et al. ( 2001) CBW Model   Conclusions  Model output is very sensitive to effective refuge size and use of insecticide sprays on Bollgard fields to control CBW.

 There is a 10 fold increase in time to resistance for CBW when Bollgard cotton is sprayed with pyrethroids.

 Model is limited, there is no spatial or temporal dynamic and " effective refuge size" should be recalculated. 48 Gustafson et al. ( 2001) CBW Model   Conclusions  Despite the issues associated with the calculation of " effective refuge size," inclusion of alternative hosts in the model will delay resistance much longer than a 5%

unsprayed, structured non Bt cotton refuge.

 Model was not rerun with parameter values derived from the results of the synthetic pyrethroid overspray studies ( Greenplate, 2004) and the alternate host studies ( Head and Voth, 2004). If model had been updated to include study results, the results would likely have supported the continuation of the 5% external,

unsprayed, structured refuge option. 49 Overall EPA Conclusion: Bollgard and Bollgard II CBW Resistance Management  Data from the N S movement study, pyrethroid overspray studies, alternative host studies support the continuation of the 5% external, unsprayed,

structured non Bt cotton refuge option for CBW resistance management. 50 Acknowledgements  Alan Reynolds, M. S., OPP/ BPPD  Hilary Hill, M. S., OPP/ BPPD  Tessa Milofsky, M. S., OPP/ BPPD 51 Bollgard and Bollgard II CBW Resistance Management SAP Questions 1. North south movement. The Agency requests that the SAP comment on whether CBW reverse migration is expected to have any significant impact on CBW adaptation to Bt crops. 52 Bollgard and Bollgard II CBW Resistance Management SAP Questions 2. Pyrethroid Oversprays.

a. The Agency requests that the SAP comment on whether pyrethroid oversprays in Bollgard cotton fields are likely to increase the level of control of CBW,

delay the evolution of resistance, and increase the relative effectiveness of the 5% external, unsprayed,

structured refuge.

b. The Agency also requests that the SAP comment on EPA's recommendation that pyrethroid oversprays not be included as a parameter in the Gustafson et al.

( 2004) model for Bollgard II. 53 Bollgard and Bollgard II CBW Resistance Management SAP Questions 2. Cont.

c. The Agency requests the SAP comment on whether the cotton bollworm larvae coming from Bollgard fields are more tolerant to the Cry1Ac protein than those larvae coming from the non Bollgard fields. What, if any, additional genetic work should be conducted to better understand the nature of this Cry1Ac tolerance.

d. The Agency requests the SAP to comment on the value of using a Cry1Ac resistant CBW colony to investigate the genetic basis for CBW survival on Bollgard cotton. 54 Bollgard and Bollgard II CBW Resistance Management SAP Questions 3. Alternative Hosts.

a. Based on the larval productivity analyses, adult productivity analyses, and satellite imaging analysis,

the Agency asks the SAP to comment on the relative contribution of the C3 and C4 alternate hosts as unstructured refugia to dilute CBW resistance.

b. Based on the data, the Agency also asks the SAP to comment on the spatial and temporal scale across the landscape, e. g., 1 mile, 10 mile etc., in which CBW adult production should be evaluated. 55 Bollgard and Bollgard II CBW Resistance Management SAP Questions 3. Cont.

c. The Agency asks the SAP to comment on how to quantitatively or semi quantitatively calculate " effective refuge size" locally and regionally using available data ( see above). 56 Bollgard and Bollgard II CBW Resistance Management SAP Questions 4. Gustafson et al. CBW Model.

a. The Agency asks the SAP to comment on the " effective refuge size" calculation. Does the SAP agree with the Agency's conclusion that " effective refuge size" is a weighted average of the proportion of moths coming from each alternate host for each CBW generation ( 5 to 6 generations) in each cotton production system ( geography)?

. 57 Bollgard and Bollgard II CBW Resistance Management SAP Questions 4. Cont.

b. The Agency requests the SAP to comment on the strengths and weaknesses of the Gustafson et al. ( 2004) model and its utility with regard to the effective contribution of alternate hosts as natural refuge per generation. How would the model output be altered if the calculation of " effective refuge size" is changed ( see a. above). What are the SAP's recommendations for refining the Gustafson et al. ( 2004) CBW resistance management model or using a different CBW resistance management model to more appropriately consider the spatial and temporal dynamics of CBW utilization of alternative hosts by generation based on the data in Head and Voth ( 2004)? 58 Bollgard and Bollgard II CBW Resistance Management SAP Questions 4. Cont.

c. The Agency requests the SAP to comment on validity of using the average pyrethroid efficacy value against CBW based on all the field studies conducted in all four states ( North Carolina, Louisiana, Mississippi,

and South Carolina) as the parameter value in the Gustafson et al. ( 2004) model rather than just the Brickle et al. ( 2001) data from South Carolina.


[Federal Register Volume 84, Number 120 (Friday, June 21, 2019)]
[Notices]
[Pages 29212-29213]
[FR Doc No: 2019-13142]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-1620]

Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory
Committee; Amendment of Notice

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing an
amendment to the notice of meeting of the Pediatric Oncology
Subcommittee of the Oncologic Drugs Advisory Committee. This meeting
was announced in the Federal Register of May 6, 2019. The amendment is
being made to reflect a change in the DATES, Agenda, and Procedure
portions of the document. There are no other changes.

FOR FURTHER INFORMATION CONTACT: Lauren Tesh Hotaki, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301-
796-9001, Fax:<PHONE_NUMBER>, email<EMAIL_ADDRESS>or FDA Advisory
Committee Information Line, 1-800-741-8138<PHONE_NUMBER> in the
Washington, DC area). Please call the Information Line for up-to-date
information on this meeting.

SUPPLEMENTARY INFORMATION: In the Federal Register of May 6, 2019 (84
FR 19788), FDA announced that a meeting of the Pediatric Oncology
Subcommittee of the Oncologic Drugs Advisory Committee would be held on
June 20, 2019. On page 19788, in the first column, the DATES portion of
the document is changed to read as follows:
    Dates: The meeting will be held on June 20, 2019, from 9 a.m. to
3:30 p.m.
    On page 19789, in the second column, the second paragraph of the
Agenda portion of the document is changed to read as follows:
    During the afternoon session, information will be presented to
gauge investigator interest in exploring potential pediatric
development plans for one product in early stages of development for
adult cancer indications. The subcommittee will consider and discuss
issues concerning diseases to be studied, patient populations to be
included, and possible study designs in the development of these
products for pediatric use. The discussion will also provide
information to the Agency pertinent to the formulation of written

requests for pediatric studies, if appropriate. The product under
consideration is ONC201, presentation by Oncoceutics Inc.
    On page 19789, in the third column, the third sentence of the
Procedure portion of the document is changed to read as follows:
    Oral presentations from the public will be scheduled between
approximately 10:50 a.m. and 11:20 a.m. and 1:50 p.m. and 2:20 p.m.
    This notice is issued under the Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14, relating to the advisory committees.

    Dated: June 14, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-13142 Filed 6-20-19; 8:45 am]
 BILLING CODE 4164-01-P