[Federal Register Volume 80, Number 211 (Monday, November 2, 2015)]
[Rules and Regulations]
[Pages 67313-67314]
[FR Doc No: 2015-27817]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 866

[Docket No. FDA-2015-N-3392]

Medical Devices; Immunology and Microbiology Devices;
Classification of Gastrointestinal Microorganism Multiplex Nucleic
Acid-Based Assay

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

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SUMMARY: The Food and Drug Administration (FDA) is classifying a
gastrointestinal microorganism multiplex nucleic acid-based assay into
class II (special controls). The Agency is classifying the device into
class II (special controls) in order to provide a reasonable assurance
of safety and effectiveness of the device.

DATES: This order is effective November 2, 2015. The classification was
applicable January 14, 2013.

FOR FURTHER INFORMATION CONTACT: Andrew Grove, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5515, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    In accordance with section 513(f)(1) of the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) (21 U.S.C. 360c(f)(1)), devices that were
not in commercial distribution before May 28, 1976 (the date of
enactment of the Medical Device Amendments of 1976), generally referred
to as postamendments devices, are classified automatically by statute
into class III without any FDA rulemaking process. These devices remain
in class III and require premarket approval, unless and until the
device is classified or reclassified into class I or II, or FDA issues
an order finding the device to be substantially equivalent, in
accordance with section 513(i) of the FD&C Act, to a predicate device
that does not require premarket approval. The Agency determines whether
new devices are substantially equivalent to predicate devices by means
of premarket notification procedures in section 510(k) of the FD&C Act
(21 U.S.C. 360(k)) and part 807 (21 CFR part 807) of the regulations.
    Section 513(f)(2) of the FD&C Act, as amended by section 607 of the
Food and Drug Administration Safety and Innovation Act (Pub. L. 112-
144), provides two procedures by which a person may request FDA to
classify a device under the criteria set forth in section 513(a)(1).
Under the first procedure, the person submits a premarket notification
under section 510(k) of the FD&C Act for a device that has not
previously been classified and, within 30 days of receiving an order
classifying the device into class III under section 513(f)(1) of the
FD&C Act, the person requests a classification under section 513(f)(2).
Under the second procedure, rather than first submitting a premarket
notification under section 510(k) of the FD&C Act and then a request
for classification under the first procedure, the person determines
that there is no legally marketed device upon which to base a
determination of substantial equivalence and requests a classification
under section 513(f)(2) of the FD&C Act. If the person submits a
request to classify the device under this second procedure, FDA may
decline to undertake the classification request if FDA identifies a
legally marketed device that could provide a reasonable basis for
review of substantial equivalence with the device or if FDA determines
that the device submitted is not of ``low-moderate risk'' or that
general controls would be inadequate to control the risks and special
controls to mitigate the risks cannot be developed.
    In response to a request to classify a device under either
procedure provided by section 513(f)(2) of the FD&C Act, FDA will
classify the device by written order within 120 days. This
classification will be the initial classification of the device.
    In accordance with section 513(f)(1) of the FD&C Act, FDA issued an
order on January 03, 2013 automatically classifying the xTAG[supreg]
Gastrointestinal Pathogen Panel (GPP) in class III, because it was not
substantially equivalent to a device that was introduced or delivered
for introduction into interstate commerce for commercial distribution
before May 28, 1976, nor to a device that was subsequently reclassified
into class I or class II. On January 10, 2013, Luminex Molecular
Diagnostics, submitted a request for de novo classification of the
xTAG[supreg] GPP under section 513(f)(2) of the FD&C Act.
    In accordance with section 513(f)(2) of the FD&C Act, FDA reviewed
the request for de novo classification in order to classify the device
under the criteria for classification set forth in section 513(a)(1) of
the FD&C Act. FDA classifies devices into class II if general controls
by themselves are insufficient to provide reasonable assurance of
safety and effectiveness, but there is sufficient information to
establish special controls to provide reasonable assurance of the
safety and effectiveness of the device for its intended use. After
review of the information submitted in the request, FDA determined that
the device can be classified into class II with the establishment of
special controls. FDA believes these special controls will provide
reasonable assurance of the safety and effectiveness of the device.
    Therefore, on January 14, 2013, FDA issued an order to the
requestor classifying the device into class II. FDA is codifying the
classification of the device by adding 21 CFR 866.3990 (Sec.
866.3990).
    Following the effective date of this final classification
administrative order, any firm submitting a premarket notification
(510(k)) for a gastrointestinal microorganism multiplex nucleic acid-
based assay will need to comply with the special controls named in this
final administrative order.
    The device is assigned the generic name gastrointestinal
microorganism multiplex nucleic acid-based assay, and it is identified
as a qualitative in vitro diagnostic device intended to simultaneously
detect and identify multiple gastrointestinal microbial nucleic acids
extracted from human stool specimens. The device detects specific
nucleic acid sequences for organism identification as well as for
determining the presence of toxin genes. The detection and
identification of a specific gastrointestinal microbial nucleic acid
from individuals exhibiting signs and symptoms of gastrointestinal
infection aids in the diagnosis of gastrointestinal infection when used
in conjunction with clinical evaluation and other laboratory findings.
A gastrointestinal microorganism multiplex nucleic acid-based assay
also aids in the detection and identification of acute gastroenteritis
in the context of outbreaks.
    FDA has identified the following risks to health associated with
this type of device and the measures required to mitigate these risks
in table 1:

           Table 1--Identified Risks and Required Mitigations
------------------------------------------------------------------------
            Identified risks                   Mitigation measures
------------------------------------------------------------------------
Failure of the device to detect and      The FDA document entitled
 identify a targeted organism when such   ``Class II Special Controls
 organism is present in the specimen      Guideline: Gastrointestinal
 (i.e., false negative result for         Microorganism Multiplex
 presence of organism).                   Nucleic Acid-Based Assays for
                                          Detection and Identification
                                          of Microorganisms and Toxin
                                          Genes from Human Stool
                                          Specimens,'' which addresses
                                          this risk through: Specific
                                          device description
                                          requirements, performance
                                          studies, and labeling.
Detection of the targeted microorganism  The FDA document entitled
 when such organism is not present in     ``Class II Special Controls
 the specimen (i.e., false positive       Guideline: Gastrointestinal
 result for presence of organism).        Microorganism Multiplex
                                          Nucleic Acid-Based Assays for
                                          Detection and Identification
                                          of Microorganisms and Toxin
                                          Genes from Human Stool
                                          Specimens,'' which addresses
                                          this risk through: Specific
                                          device description
                                          requirements, performance
                                          studies, and labeling.
Failure to correctly interpret test      The FDA document entitled
 results.                                 ``Class II Special Controls
                                          Guideline: Gastrointestinal
                                          Microorganism Multiplex
                                          Nucleic Acid-Based Assays for
                                          Detection and Identification
                                          of Microorganisms and Toxin
                                          Genes from Human Stool
                                          Specimens,'' which addresses
                                          this risk through: Specific
                                          device description
                                          requirements and labeling.
------------------------------------------------------------------------

    FDA believes that the measures set forth in the special controls
guideline entitled ``Class II Special Controls Guideline:
Gastrointestinal Microorganism Multiplex Nucleic Acid-Based Assays for
Detection and Identification of Microorganisms and Toxin Genes from
Human Stool Specimens'' are necessary, in addition to general controls,
to mitigate the risks to health described in table 1.

II. Premarket Notification

    A gastrointestinal microorganism multiplex nucleic acid-based assay
is a prescription device. Section 510(m) of the FD&C Act provides that
FDA may exempt a class II device from the premarket notification
requirements under section 510(k) of the FD&C Act if FDA determines
that premarket notification is not necessary to provide reasonable
assurance of the safety and effectiveness of the device. For this type
of device, FDA has determined that premarket notification is necessary
to provide reasonable assurance of the safety and effectiveness of the
device. Therefore, this type of device is not exempt from premarket
notification requirements. Persons who intend to market this type of
device must submit to FDA a premarket notification, prior to marketing
the device, which contains information about the gastrointestinal
microorganism multiplex nucleic acid-based assay they intend to market.

III. Environmental Impact

    We have determined under 21 CFR 25.34(b) that this action is of
type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.

IV. Paperwork Reduction Act of 1995

    This final administrative order establishes special controls that
refer to previously approved collections of information found in other
FDA regulations. These collections of information are subject to review
by the Office of Management and Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of
information in 21 CFR part 807, subpart E, regarding premarket
notification submissions have been approved under OMB control number
0910-0120; the collections of information in 21 CFR part 820 regarding
quality systems have been approved under OMB control number 0910-0073;
and the collections of information in 21 CFR parts 801 and 809
regarding labeling have been approved under OMB control number 0910-
0485.

List of Subjects in 21 CFR Part 866

    Biologics, Laboratories, Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
866 is amended as follows:

PART 866--IMMUNOLOGY AND MICROBIOLOGY DEVICES

0
1. The authority citation for part 866 continues to read as follows:

    Authority:  21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

0
2. Add Sec.  866.3990 to subpart D to read as follows:

Sec.  866.3990  Gastrointestinal microorganism multiplex nucleic acid-
based assay.

    (a) Identification. A gastrointestinal microorganism multiplex
nucleic acid-based assay is a qualitative in vitro diagnostic device
intended to simultaneously detect and identify multiple
gastrointestinal microbial nucleic acids extracted from human stool
specimens. The device detects specific nucleic acid sequences for
organism identification as well as for determining the presence of
toxin genes. The detection and identification of a specific
gastrointestinal microbial nucleic acid from individuals exhibiting
signs and symptoms of gastrointestinal infection aids in the diagnosis
of gastrointestinal infection when used in conjunction with clinical
evaluation and other laboratory findings. A gastrointestinal
microorganism multiplex nucleic acid-based assay also aids in the
detection and identification of acute gastroenteritis in the context of
outbreaks.
    (b) Classification. Class II (special controls). The special
controls are set forth in FDA's guideline document entitled: ``Class II
Special Controls Guideline: Gastrointestinal Microorganism Multiplex
Nucleic Acid-Based Assays for Detection and Identification of
Microorganisms and Toxin Genes from Human Stool Specimens.'' For
availability of the guideline document, see Sec.  866.1(e).

    Dated: October 27, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-27817 Filed 10-30-15; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 87, Number 23 (Thursday, February 3, 2022)]
[Notices]
[Page 6187]
[FR Doc No: 2022-02250]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4635-DR; Docket ID FEMA-2022-0001]

Washington; Major Disaster and Related Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This is a notice of the Presidential declaration of a major
disaster for the State of Washington (FEMA-4635-DR), dated January 5,
2022, and related determinations.

DATES: The declaration was issued January 5, 2022.

FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Notice is hereby given that, in a letter
dated January 5, 2022, the President issued a major disaster
declaration under the authority of the Robert T. Stafford Disaster
Relief and Emergency Assistance Act, 42 U.S.C. 5121 et seq. (the
``Stafford Act''), as follows:

    I have determined that the damage in certain areas of the State
of Washington resulting from flooding and mudslides during the
period of November 13 to November 15, 2021, is of sufficient
severity and magnitude to warrant a major disaster declaration under
the Robert T. Stafford Disaster Relief and Emergency Assistance Act,
42 U.S.C. 5121 et seq. (the ``Stafford Act''). Therefore, I declare
that such a major disaster exists in the State of Washington.
    In order to provide Federal assistance, you are hereby
authorized to allocate from funds available for these purposes such
amounts as you find necessary for Federal disaster assistance and
administrative expenses.
    You are authorized to provide Individual Assistance in the
designated areas and Hazard Mitigation throughout the State.
Consistent with the requirement that Federal assistance be
supplemental, any Federal funds provided under the Stafford Act for
Hazard Mitigation and Other Needs Assistance under section 408 will
be limited to 75 percent of the total eligible costs.
    Further, you are authorized to make changes to this declaration
for the approved assistance to the extent allowable under the
Stafford Act.

    The time period prescribed for the implementation of section
310(a), Priority to Certain Applications for Public Facility and Public
Housing Assistance, 42 U.S.C. 5153, shall be for a period not to exceed
six months after the date of this declaration.
    The Federal Emergency Management Agency (FEMA) hereby gives notice
that pursuant to the authority vested in the Administrator, under
Executive Order 12148, as amended, Toney L. Raines, of FEMA is
appointed to act as the Federal Coordinating Officer for this major
disaster.
    The following areas of the State of Washington have been designated
as adversely affected by this major disaster:

    Clallam, Skagit, and Whatcom Counties and the Lummi Nation,
Nooksack Indian Tribe, and Quileute Tribe for Individual Assistance.
    All areas within the State of Washington are eligible for
assistance under the Hazard Mitigation Grant Program.

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

Deanne Criswell,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2022-02250 Filed 2-2-22; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register Volume 84, Number 60 (Thursday, March 28, 2019)]
[Notices]
[Pages 11804-11805]
[FR Doc No: 2019-05976]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0155]

Veterinary Feed Directive Regulation Questions and Answers; Small
Entity Compliance Guide; Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA, we, or Agency) is
announcing the availability of a draft revised guidance for industry
(GFI) #120 entitled ``Veterinary Feed Directive Regulation Questions
and Answers.'' This draft revised guidance document, when finalized,
will aid industry in complying with the requirements of the veterinary
feed directive (VFD) regulation.

DATES: Submit either electronic or written comments on the draft
revised guidance by May 28, 2019 to ensure that the Agency considers
your comment on this draft revised guidance before it begins work on
the final version of the guidance.

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

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2010-N-0155 for ``Veterinary Feed Directive Regulation Questions
and Answers.'' Received comments will be placed in the docket and,
except for those submitted as ``Confidential Submissions,'' publicly
viewable at https://www.regulations.gov or at the Dockets Management
Staff between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the draft revised
guidance to the Policy and Regulations Staff (HFV-6), Center for
Veterinary Medicine, Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855. 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 revised guidance
document.

FOR FURTHER INFORMATION CONTACT: Dragan Momcilovic, Center for
Veterinary Medicine (HFV-226), Food and Drug Administration, 7519
Standish Pl., Rockville, MD 20855,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of September 30, 2015 (80 FR 58602), FDA
announced the availability of GFI #120 to assist industry in complying
with the VFD regulation in 21 CFR part 558. This guidance also serves
as a Small Entities Compliance Guide (SECG), to aid industry in
complying with the requirements of the VFD final rule that published in
the Federal Register on June 3, 2015 (80 FR 31708). FDA prepared this
SECG in accordance with section 212 of the Small Business Regulatory
Enforcement Fairness Act (Pub. L. 104-121). This document provides
guidance to small businesses on the requirements of the final rule. We
are announcing the availability of draft revised GFI #120 to provide
additional information in response to questions that have been
submitted by interested parties since 2015.

II. Significance of Guidance

    This level 1 draft revised guidance is being issued consistent with
FDA's good guidance practices regulation (21 CFR 10.115). The draft
revised guidance, when finalized, will represent the current thinking
of FDA on ``Veterinary Feed Directive Regulation Questions and
Answers.'' It does not establish any rights for any person and is not
binding on FDA or the public. You can use an alternative approach if it
satisfies the requirements of the applicable statutes and regulations.
This guidance is not subject to Executive Order 12866.

III. Paperwork Reduction Act of 1995

    This draft revised guidance refers to previously approved
collections of information found in FDA regulations. These collections
of information are subject to review by the Office of Management and
Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520). The collections of information in 21 CFR 558.6 have been
approved under OMB control number 0910-0363.

IV. Electronic Access

    Persons with access to the internet may obtain the draft revised
guidance at either https://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm or
https://www.regulations.gov. Use the FDA website listed in the previous
sentence to find the most current version of the guidance.

    Dated: March 22, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-05976 Filed 3-27-19; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 83, Number 111 (Friday, June 8, 2018)]
[Notices]
[Pages 26742-26744]
[FR Doc No: 2018-12355]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2007-28043]

Hours of Service (HOS) of Drivers; American Pyrotechnics Assn.
(APA); Request To Add New Members to Current APA Exemption; Request for
Comments

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

ACTION: Notice of application for exemption; request for comments.

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SUMMARY: The American Pyrotechnics Association (APA) has requested an
exemption for three member companies--Artisan Pyrotechnics Inc.,
Montana Display Fireworks, Inc., and ZY Pyrotechnics, LLC dba
Skyshooter Displays, Inc.--from the prohibition on driving commercial
motor vehicles (CMVs) after the 14th hour after the driver comes on
duty. Fifty APA members currently hold such an exemption during the
Independence Day period each year, terminating on July 8, 2020. If
granted, this exemption would terminate at the same time as the other
50 exempted carriers. The APA maintains that the terms and conditions
of the limited exemption would ensure a level of safety equivalent to,
or greater than, the level of safety achieved without the exemption.

DATES: Comments are due no later than July 9, 2018.

ADDRESSES: You may submit comments bearing the Federal Docket
Management System (FDMS) Docket ID FMCSA-2007-28043 using any of the
following methods:
     Federal eRulemaking Portal: www.regulations.gov. Follow
the online instructions for submitting comments.
     Mail: Docket Management Facility, U.S. Department of
Transportation, 1200 New Jersey Avenue SE, West Building, Ground Floor,
Room W12-140, Washington, DC 20590-0001.
     Hand Delivery or Courier: West Building, Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.
     Fax: 1-202-493-2251.
    Each submission must include the Agency name and the docket number
for this notice. Note that DOT posts all comments received without
change to www.regulations.gov, including any personal information
included in a comment. Please see the Privacy Act heading below.
    Docket: For access to the docket to read background documents or
comments, go to www.regulations.gov at any time or visit 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. The on-line FDMS is available 24 hours each
day, 365 days each year. If you want acknowledgment that we received
your comments, please include a self-addressed, stamped envelope or
postcard or print the acknowledgement page that appears after
submitting comments on-line.
    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.

FOR FURTHER INFORMATION CONTACT: Ms. Pearlie Robinson, FMCSA Driver and
Carrier Operations Division; Office of Carrier, Driver and Vehicle
Safety Standards; Telephone:<PHONE_NUMBER>. Email: [email protected]. If you
have questions on viewing or submitting material to the docket, contact
Docket Services, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Public Participation and Request for Comments

    FMCSA encourages you to participate by submitting comments and
related materials.

Submitting Comments

    If you submit a comment, please include the docket number for this
notice (FMCSA-2007-28043), indicate the specific section of this
document to which the comment applies, and provide a reason for
suggestions or recommendations. 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 the Agency can contact you if it has questions
regarding your submission.
    To submit your comment online, go to www.regulations.gov and put
the docket number, ``FMCSA-2007-28043'' in the ``Keyword'' box, and
click ``Search.'' When the new screen appears, click on ``Comment
Now!'' button and type your comment into the text box in 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.

Viewing Comments and Documents

    To view comments, as well as documents mentioned in this preamble
as being available in the docket, go to www.regulations.gov and insert
the docket number, ``FMCSA-2007-28043'' in the ``Keyword'' box and
click ``Search.'' Next, click ``Open Docket Folder'' button and choose
the document listed to review. If you do not have access to the
internet, you may view the docket online by visiting the Docket
Management Facility 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., e.t., Monday through Friday, except Federal holidays.

II. Legal Basis

    FMCSA has authority under 49 U.S.C. 31136(e) and 31315 to grant
exemptions from certain parts of the Federal Motor Carrier Safety
Regulations. FMCSA must publish a notice of each exemption request in
the Federal Register (49 CFR 381.315(a)). The Agency must provide the
public an opportunity to inspect the information relevant to the
application, including any safety analyses that have been conducted.
The Agency must also provide an opportunity for public comment on the
request.
    The Agency reviews the safety analyses and the public comments, and
determines whether granting the exemption would likely achieve a level
of safety equivalent to, or greater than, the level that would be
achieved by compliance with the current regulation (49 CFR 381.305).
The decision of the Agency must be published in the Federal Register
(49 CFR 381.315(b)) with the reason for the grant or denial, and, if
granted, the specific person or class of persons receiving the
exemption, and the regulatory provision or provisions from which
exemption is granted. The notice must also specify the effective period
of the exemption (up to 5 years), and explain the terms and conditions
of the exemption. The exemption may be renewed (49 CFR 381.300(b)).

APA Application for Exemption

    The HOS rule in 49 CFR 395.3(a)(2) prohibits the driver of a
property-carrying CMV from driving after the 14th hour after coming on
duty following 10 consecutive hours off duty. In 2016, the APA, a trade
association representing the domestic fireworks industry was granted
exemptions for 51 member companies through the annual Independence Day
periods ending on July 8, 2020 [81 FR 43701, July 5, 2016]. One of the
51 APA member companies, Island Fireworks, DOT #414583, no longer
requires the exemption, leaving the total at 50. APA has requested an
exemption for Artisan Pyrotechnics Inc., DOT #1898096, Montana Display
Fireworks, Inc., DOT #1030231, and ZY Pyrotechnics, LLC dba Skyshooter
Displays, Inc., DOT #2149202, which would increase the total to 53. The
exemption for these APA carriers, if granted, would expire on July 8,
2020. Although this is less than the 5-year exemption period authorized
by 49 U.S.C. 31315(b)(2), as amended by section 5206(a)(3) of the
Fixing America's Surface Transportation (FAST) Act (Pub. L. 114-94, 129
Stat. 1312, 1537, Dec. 4, 3015), FMCSA believes that the interests of
the APA members and the Agency would best be served by harmonizing, as
far as possible, the expiration dates of all such fireworks-related
exemptions. Like the other 50 member companies, the three new member
companies would be subject to all of the terms and conditions of the
exemption.
    The initial APA application for relief from the 14-hour rule was
submitted in 2004; a copy is in the docket. That application fully
describes the nature of the pyrotechnic operations of CMV

drivers during a typical Independence Day period.
    As stated in the 2004 request, the CMV drivers employed by APA
member companies are trained pyro-technicians who hold commercial
driver's licenses (CDLs) with hazardous materials (HM) endorsements.
They transport fireworks and related equipment by CMVs on a very
demanding schedule during a brief Independence Day period, often to
remote locations. After they arrive, the drivers are responsible for
set-up and staging of the fireworks shows.
    The APA states that it is seeking an additional exemption for the
three new member companies because compliance with the current 14-hour
rule in 49 CFR 395.3(a)(2) would impose a substantial economic hardship
on numerous cities, towns and municipalities, as well as its member
companies. To meet the demand for fireworks without the exemptions, APA
states that its member companies would be required to hire a second
driver for most trips. The APA advises that the result would be a
substantial increase in the cost of the fireworks shows--beyond the
means of many of its members' customers--and that many Americans would
be denied this important component of the celebration of Independence
Day.

Method To Ensure an Equivalent or Greater Level of Safety

    The APA believes that the exemption would not adversely affect the
safety of the fireworks transportation provided by this motor carrier.
According to APA, its member companies have operated under this
exemption for 11 previous Independence Day periods without a reported
motor carrier safety incident. Moreover, it asserts, without the extra
time provided by the exemption, safety would decline because APA
drivers would be unable to return to their home base after each show.
They would be forced to park the CMVs carrying HM 1.1G, 1.3G and 1.4G
products in areas less secure than the motor carrier's home base. As a
condition of holding the exemption, each motor carrier is required to
notify FMCSA within 5 business days of any accident (as defined in 49
CFR 390.5) involving the operation of any its CMVs while under this
exemption. To date, FMCSA has received no accident notifications, nor
is the Agency aware of any accidents reportable under terms of the
prior APA exemptions.
    In its exemption request, APA asserts that the operational demands
of this unique industry minimize the risks of CMV crashes. In the last
few days before July 4, these drivers transport fireworks over
relatively short routes from distribution points to the site of the
fireworks display, and normally do so in the early morning when traffic
is light. At the site, they spend considerable time installing, wiring,
and safety-checking the fireworks displays, followed by several hours
off duty in the late afternoon and early evening prior to the event.
During this time, the drivers are able to rest and nap, thereby
reducing or eliminating the fatigue accumulated during the day. Before
beginning another duty day, these drivers must take 10 consecutive
hours off duty, the same as other CMV drivers.

Terms and Conditions of the Exemption

Period of the Exemption

    The requested exemption from 49 CFR 395.3(a)(2) would be effective
from June 28 through July 8, at 11:59 p.m. local time, each year
through 2020.

Terms and Conditions of the Exemption

    During the 2018 Independence Day period, the exemption from 49 CFR
395.3(a)(2) would be limited to drivers employed by the 50 motor
carriers already covered by the exemption, plus (if approved) the three
carriers now seeking an exemption. Section 395.3(a)(2) prohibits a
driver from driving a CMV after the 14th hour after coming on duty and
does not permit off-duty periods to extend the 14-hour limit. Drivers
covered by this exemption would be able to exclude off-duty and
sleeper-berth time of any length from the calculation of the 14-hour
limit. This exemption would be contingent on each driver driving no
more than 11 hours in the 14-hour period after coming on duty, as
extended by any off-duty or sleeper-berth time in accordance with this
exception. The exemption would be further contingent on each driver
having a full 10 consecutive hours off duty following 14 hours on duty
prior to beginning a new driving period. The carriers and drivers must
comply with all other requirements of the Federal Motor Carrier Safety
Regulations (49 CFR parts 350-399) and Hazardous Materials Regulations
(49 CFR parts 105-180).

Preemption

    In accordance with 49 U.S.C. 31315(d), as implemented by 49 CFR
381.600, during the period this exemption is in effect, no State shall
enforce any law or regulation applicable to interstate commerce that
conflicts with or is inconsistent with this exemption with respect to a
firm or person operating under the exemption. States may, but are not
required to, adopt the same exemption with respect to operations in
intrastate commerce.

FMCSA Notification

    Exempt motor carriers would be required to notify FMCSA within 5
business days of any accidents (as defined by 49 CFR 390.5) involving
the operation of any of their CMVs while under this exemption. The
notification must be by email to [email protected] and include the
following information:
    a. Name of the Exemption: ``APA'',
    b. Date of the accident,
    c. City or town, and State, in which the accident occurred, or
which is closest to the scene of the accident,
    d. Driver's name and driver's license State, number, and class,
    e. Co-Driver's name and driver's license State, number, and class,
    f. Vehicle company number and power unit license plate State and
number,
    g. Number of individuals suffering physical injury,
    h. Number of fatalities,
    i. The police-reported cause of the accident,
    j. Whether the driver was cited for violation of any traffic laws,
or motor carrier safety regulations, and
    k. The total driving time and the total on-duty time of the CMV
driver at the time of the accident.
    In addition, if there are any injuries or fatalities, the carrier
must forward the police accident report to [email protected] as soon as
available.

Termination

    The FMCSA does not believe the motor carriers and drivers covered
by this exemption, if granted, would experience any deterioration of
their safety record.
    However, should this occur, FMCSA would take all steps necessary to
protect the public interest, including revocation of the exemption. The
FMCSA will immediately revoke the exemption for failure to comply with
its terms and conditions. Exempt motor carriers and drivers would be
subject to FMCSA monitoring while operating under this exemption.

    Issued on: June 4, 2018.
Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2018-12355 Filed 6-7-18; 8:45 am]
 BILLING CODE 4910-EX-P


6976 Federal Register / Vol. 69, No. 29 / Thursday, February 12, 2004 / Notices develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information. Respondents/ Affected Entities: Owners or operators of magnetic tape coating facilities. Estimated Number of Respondents: 6. Frequency of Response: Initial, quarterly, semiannually. Estimated Total Annual Hour Burden: 2,017 hours. Estimated Total Cost: $ 216,000, which includes $ 34,000 annualized capital/ startup costs, $ 53,000 annual O& M costs and $ 129,000 labor costs. Changes in the Estimates: There is a decrease of 1,874 hours in the total estimated burden currently identified in the OMB Inventory of Approved ICR Burdens. This decrease is due to a reduction in the number of sources affected by the standard.

Dated: January 22, 2004. Doreen Sterling, Acting Director, Collection Strategies Division. [ FR Doc. 04   3086 Filed 2   11   04; 8: 45 am]

BILLING CODE 6560   50   P ENVIRONMENTAL PROTECTION AGENCY [ OPPT   2003   0017; FRL   7621   3]

Agency Information Collection Activities; Submission to OMB for Review and Approval; Comment Request; Voluntary Cover Sheet for TSCA Submissions, EPA ICR No. 1780.03, OMB No. 2070   0156 AGENCY: Environmental Protection Agency ( EPA). ACTION: Notice.

SUMMARY: In compliance with the Paperwork Reduction Act ( 44 U. S. C. 3501 et seq.), this document announces that the following Information Collection Request ( ICR) has been forwarded to the Office of Management and Budget ( OMB) for review and approval: Voluntary Cover Sheet for TSCA Submission ( EPA ICR # 1780.03; OMB # 2070   0156). This is a request to renew an existing approved collection. This ICR is scheduled to expire on February 29, 2004. Under OMB regulations, the Agency may continue to conduct or sponsor the collection of information while this submission is pending at OMB. This ICR describes the nature of the information collection and its estimated cost. DATES: Additional comments may be submitted on or before March 15, 2004. ADDRESSES: Submit your comments, referencing docket ID Number OPPT   2003   0017, to ( 1) EPA online using EDOCKET ( our preferred method), by email to oppt. ncic@ epa. gov or by mail to: Document Control Office ( DCO), Office of Pollution Prevention and Toxics ( OPPT), Environmental Protection Agency, Mailcode: 7407T, 1200 Pennsylvania Ave., NW., Washington, DC 20460, and ( 2) OMB at: Office of Information and Regulatory Affairs, Office of Management and Budget ( OMB), Attention: Desk Officer for EPA, 725 17th Street, NW., Washington, DC 20503.

FOR FURTHER INFORMATION CONTACT: Barbara Cunningham, Acting Director, Environmental Assistance Division, Office of Pollution Prevention and Toxics, Environmental Protection Agency, Mailcode: 7408, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: 202   554   1404; e mail address: TSCAHotline epa. gov.

SUPPLEMENTARY INFORMATION: EPA has submitted the following ICR to OMB for review and approval according to the procedures prescribed in 5 CFR 1320.12. On April 18, 2003, EPA sought comments on this renewal ICR ( 68 FR 19203). EPA sought comments on this ICR pursuant to 5 CFR 1320.8( d). EPA received one comment and has addressed the comment received. EPA has established a public docket for this ICR under Docket ID No. OPPT   2003   0017, which is available for public viewing at the OPPT Docket in the EPA Docket Center ( EPA/ DC), EPA West, Room B102, 1301 Constitution Ave., NW., Washington, DC. The EPA Docket Center Public Reading Room is open from 8 a. m. to 4: 30 p. m., Monday through Friday, excluding legal holidays. The telephone number for the Reading Room is 202   566   1744, and the telephone number for the Pollution Prevention and Toxics Docket is 202   566   0280. An electronic version of the public docket is available through EPA Dockets ( EDOCKET) at http:// www. epa. gov/ edocket. Use EDOCKET to submit or view public comments, access the index listing of the contents of the public docket, and to access those documents in the public docket that are available electronically. Once in the system, select `` search,'' then key in the docket ID number identified above. Any comments related to this ICR should be submitted to EPA and OMB within 30 days of this notice. EPA's policy is that public comments, whether submitted electronically or in paper, will be made available for public viewing in EDOCKET as EPA receives them and without change, unless the comment contains copyrighted material, CBI, or other information whose public disclosure is restricted by statute. When EPA identifies a comment containing copyrighted material, EPA will provide a reference to that material in the version of the comment that is placed in EDOCKET. The entire printed comment, including the copyrighted material, will be available in the public docket. Although identified as an item in the official docket, information claimed as CBI, or whose disclosure is otherwise restricted by statute, is not included in the official public docket, and will not be available for public viewing in EDOCKET. For further information about the electronic docket, see EPA's Federal Register notice describing the electronic docket at 67 FR 38102 ( May 31, 2002), or go to www. epa. gov/ edocket. Title: Voluntary Cover Sheet for TSCA Submissions. Abstract: The Toxic Substances Control Act ( TSCA) requires industry to submit information and studies for existing chemical substances under sections 4, 6, and 8. Under normal reporting conditions, EPA receives thousands of submissions each year; each submission represents on average three studies. In addition, specific data call ins can be imposed on industry. As a follow up to industry experience with a 1994 TSCA data call in, the Chemical Manufacturers Association ( CMA, now known as the American Chemistry Council ( ACC)), the Specialty Organics Chemical Manufacturers Association ( SOCMA), and the Chemical Industry Data Exchange ( CIDX), in cooperation with EPA, took an interest in pursuing electronic transfer of TSCA summary data and of full submissions to EPA. In particular, ACC developed a standardized cover sheet for voluntary use by industry as a first step to an electronic future and to begin familiarizing companies with standard requirements and concepts of electronic transfer. This form is designed for voluntary use as a cover sheet for submissions of information under TSCA sections 4, 8( d) and 8( e). The cover sheet facilitates submission of information by displaying certain basic data elements, permitting VerDate jul< 14> 2003 14: 33 Feb 11, 2004 Jkt 203001 PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 12FEN1. SGM 12FEN1 6977 Federal Register / Vol. 69, No. 29 / Thursday, February 12, 2004 / Notices EPA more easily to identify, log, track, distribute, review and index submissions, and to make information publicly available more rapidly and at reduced cost, to the mutual benefit of both the respondents and EPA. Responses to the collection of information are voluntary. Respondents may claim all or part of a notice as CBI. EPA will disclose information that is covered by a CBI claim only to the extent permitted by, and in accordance with, the procedures in 40 CFR part 2. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for EPA's regulations in 40 CFR are listed in 40 CFR part 9 and are identified on the form and/ or instrument, if applicable. Burden Statement: The annual public reporting and recordkeeping burden for this collection of information is estimated to average 0.5 hour per response. Burden means the total time, effort or financial resources expended by persons to generate, maintain, retain or disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; develop, acquire, install and utilize technology and systems for the purposes of collecting, validating and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information. Respondents/ Affected Entities: Companies that manufacture, process, use, import or distribute in commerce chemical substances that are subject to reporting requirements under sections 4, 8( d) or 8( e) of TSCA. Frequency of Collection: On occasion. Estimated No. of Respondents: 964. Estimated Total Annual Burden on Respondents: 9,136 hours. Estimated Total Annual Costs: $ 703,435. Changes in Burden Estimates: There is an increase of 8,221 hours ( from 915 hours to 9,136 hours) in the total estimated respondent burden compared with that identified in the information collection request most recently approved by OMB. This change reflects a net increase in the estimated number of submissions under TSCA sections 4, 8( d) and 8( e) for which the Voluntary TSCA Cover Sheet could be used, in particular a substantial increase in the estimated number of TSCA section 4 submissions. Since the use of the Voluntary TSCA Cover Sheet is a direct reflection of the number of submissions received under TSCA sections 4, 8( d) and 8( e), any change in the estimated numbers of submissions under those requirements will result in a parallel change in the burden hours associated with this information collection. This increase represents an adjustment.

Dated: January 22, 2004. Doreen Sterling, Acting Director, Collection Strategies Division. [ FR Doc. 04   3087 Filed 2   11   04; 8: 45 am]

BILLING CODE 6560   50   P ENVIRONMENTAL PROTECTION AGENCY [ FRL   7621   7]

Proposed Settlement Agreement, Clean Air Act Citizen Suit AGENCY: Environmental Protection Agency ( EPA). ACTION: Notice of proposed settlement agreement; request for public comment.

SUMMARY: In accordance with section 113( g) of the Clean Air Act, as amended (`` Act''), 42 U. S. C. 7413( g), notice is hereby given of a proposed settlement agreement, to address a lawsuit filed by the Utility Air Regulatory Group in the U. S. Court of Appeals for the District of Columbia: Utility Air Regulatory Group v. EPA, No. 03   1168 ( D. C. Cir.). Petitioners challenge EPA's final rule entitled `` Revision of the Guidance on Air Quality Models: Adoption of a Preferred Long Range Transportation Model and Other Revisions,'' published at 68 FR 18444 ( April 5, 2003), adopting the CALPUFF modeling system as an additional air quality model under the Guideline on Air Quality Models, 40 CFR part 51. Under the terms of the proposed settlement agreement, EPA would issue three documents if, after review of public comments received in response to this Notice, it elects to proceed with the settlement agreement. DATES: Written comments on the proposed settlement agreement must be received by March 15, 2004. ADDRESSES: Submit your comments, identified by docket ID number OGC   2004   0001, online at http:// www. epa. gov/ edocket ( EPA's preferred method); by e mail to oei. docket@ epa. gov; mailed to EPA Docket Center, Environmental Protection Agency, Mailcode: 2822T, 1200 Pennsylvania Ave., NW., Washington, DC 20460   0001; or by hand delivery or courier to EPA Docket Center, EPA West, Room B102, 1301 Constitution Ave., NW., Washington, DC, between 8: 30 a. m. and 4: 30 p. m. Monday through Friday, excluding legal holidays. Comments on a disk or CDROM should be formatted in WordPerfect or ASCII file, avoiding the use of special characters and any form of encryption, and may be mailed to the mailing address above.

FOR FURTHER INFORMATION CONTACT: Roland Dubois, Office of General Counsel ( 2333A), U. S. Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. telephone: ( 202) 564   5626.

SUPPLEMENTARY INFORMATION:

I. Additional Information About the Proposed Settlement Agreement Petitioners raise issues concerning: ( 1) The adequacy of CALPUFF air dispersion model to address certain instances of long range transport, ( 2) the availability of EPA approved version of CALPUFF model on model developer's website potentially allowing model developer to make unauthorized changes to the model, and ( 3) the potential for misinterpretation of statements in preamble to April 5, 2003, final rule ( 68 FR 18444) discussing the role of federal land managers in evaluating air quality related values impacts. Under the Settlement Agreement, EPA would issue three documents: ( 1) A guidance document for using CALPUFF to model long range pollutant transport, ( 2) a letter to the CALPUFF model developer describing procedures for EPA approval of changes to the EPAapproved version of the CALPUFF model, and ( 3) a letter to Petitioner's counsel clarifying EPA's statement in the preamble to the rule regarding the role of federal land managers in evaluating air quality related values impacts. For a period of thirty ( 30) days following the date of publication of this notice, the Agency will receive written comments relating to the proposed settlement agreement from persons who were not named as parties to the litigation in question. The Agency will review and consider comments received, and will then: ( 1) Consent to the proposed settlement, ( 2) make any modifications deemed necessary or appropriate prior to consenting to the proposed settlement, or ( 3) withhold consent to the proposed settlement.

VerDate jul< 14> 2003 14: 33 Feb 11, 2004 Jkt 203001 PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 12FEN1. SGM 12FEN1


[Federal Register Volume 86, Number 242 (Tuesday, December 21, 2021)]
[Notices]
[Page 72296]
[FR Doc No: 2021-27541]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-93786; File No. SR-BOX-2021-14]

Self-Regulatory Organizations; BOX Exchange LLC; Notice of
Designation of Longer Period for Commission Action on Proceedings To
Determine Whether To Approve or Disapprove a Proposed Rule Change, as
Modified by Amendment No. 1, in Connection With the Proposed
Establishment of BSTX as a Facility of the Exchange

December 15, 2021.
    On June 7, 2021, BOX Exchange LLC (``Exchange'' or ``BOX'') filed
with the Securities and Exchange Commission (``Commission''), pursuant
to Section 19(b)(1) of the Securities Exchange Act of 1934 (``Act'')
\1\ and Rule 19b-4 thereunder,\2\ a proposed rule change to adopt rules
in connection with the establishment of BSTX LLC as a facility of the
Exchange. The proposed rule change was published for comment in the
Federal Register on June 24, 2021.\3\ On August 3, 2021, pursuant to
Section 19(b)(2) of the Act,\4\ the Commission designated a longer
period within which to approve the proposed rule change, disapprove the
proposed rule change, or institute proceedings to determine whether to
disapprove the proposed rule change.\5\ On September 16, 2021, the
Exchange filed Amendment No. 1 to the proposed rule change, which
replaced and superseded the proposed rule change as originally
filed.\6\ On September 21, 2021, the Commission published the proposed
rule change, as modified by Amendment No. 1, for notice and comment and
instituted proceedings to determine whether to approve or disapprove
the proposed rule change, as modified by Amendment No. 1.\7\
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 92206 (June 17,
2021), 86 FR 33402 (``Notice''). Comments on the proposed rule
change can be found at: https://www.sec.gov/comments/sr-box-2021-14/srbox202114.htm.
    \4\ 15 U.S.C. 78s(b)(2).
    \5\ See Securities Exchange Act Release No. 92556, 86 FR 43572
(August 9, 2021). The Commission designated September 22, 2021, as
the date by which the Commission shall approve or disapprove, or
institute proceedings to determine whether to approve or disapprove,
the proposed rule change.
    \6\ Amendment No. 1 is available on the Commission's website at:
https://www.sec.gov/comments/sr-box-2021-14/srbox202114-9251558-250847.pdf.
    \7\ See Securities Exchange Act Release No. 93094 (September 21,
2021), 86 FR 53365 (September 27, 2021).
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    Section 19(b)(2) of the Act \8\ provides that, after initiating
proceedings, the Commission shall issue an order approving or
disapproving the proposed rule change not later than 180 days after the
date of publication of notice of filing of the proposed rule change.
The Commission may extend the period for issuing an order approving or
disapproving the proposed rule change, however, by not more than 60
days if the Commission determines that a longer period is appropriate
and publishes the reasons for such determination. The proposed rule
change was published for notice and comment in the Federal Register on
June 24, 2021.\9\ December 21, 2021 is 180 days from that date, and
February 19, 2022 is 240 days from that date. The Commission finds it
appropriate to designate a longer period within which to issue an order
approving or disapproving the proposed rule change so that it has
sufficient time to consider the proposed rule change. Accordingly, the
Commission, pursuant to Section 19(b)(2) of the Act,\10\ designates
February 19, 2022 as the date by which the Commission shall either
approve or disapprove the proposed rule change, as modified by
Amendment No.1 (File No. SR-BOX-2021-14).
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    \8\ 15 U.S.C. 78s(b)(2).
    \9\ See Notice, supra note 3.
    \10\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\11\
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    \11\ 17 CFR 200.30-3(a)(57).
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J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2021-27541 Filed 12-20-21; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 76, Number 129 (Wednesday, July 6, 2011)]
[Notices]
[Pages 39450-39451]
[FR Doc No: 2011-16823]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-64768; File No. SR-BX-2011-040]

Self-Regulatory Organizations; Notice of Filing and Immediate
Effectiveness of Proposed Rule Change by NASDAQ OMX BX, Inc. To Amend
the BOX Fee Schedule

June 29, 2011.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on June 28, 2011, NASDAQ OMX BX, Inc. (the ``Exchange'') filed with the
Securities and Exchange Commission (``Commission'') the proposed rule
change as described in Items I and II, below, which Items have been
prepared by the self-regulatory organization. The Exchange filed the
proposed rule change pursuant to Section 19(b)(3)(A)(ii) of the Act,\3\
and Rule 19b-4(f)(2) thereunder,\4\ which renders the proposal
effective upon filing with the Commission. The Commission is publishing
this notice to solicit comments on the proposed rule change from
interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \4\ 17 CFR 240.19b-4(f)(2).
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to amend the Fee Schedule of the Boston
Options Exchange Group, LLC (``BOX'').\5\ While changes to the BOX Fee
Schedule pursuant to this proposal will be effective upon filing, the
changes will become operative on July 1, 2011. The text of the proposed
rule change is available from the principal office of the Exchange, at
the Commission's Public Reference Room, on the Exchange's Internet Web
site at http://nasdaqomxbx.cchwallstreet.com/NASDAQOMXBX/Filings and on
the Commission's Web site at http://www.sec.gov.
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    \5\ The BOX Fee Schedule can be found on the BOX Web site at
http://bostonoptions.com/pdf/BOX_Fee _Schedule.pdf.
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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 these statements may be examined at
the places specified in Item IV below. The self-regulatory organization
has prepared summaries, set forth in Sections A, B, and C below, of the
most significant aspects of such statements.

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

1. Purpose
    Section 8 of the BOX Fee Schedule currently imposes a fee of $0.50
per contract for all Eligible Orders sent to Away Exchanges in excess
of 10,000 contracts per month for each BOX Options Participant.\6\
Additionally, BOX currently exempts outbound Eligible Orders sent to
Away Exchanges, up to a maximum of 10,000 contracts per month, from the
fees and credits of Section 7 of the BOX Fee Schedule, as these
transactions are deemed to neither `add' nor `take' liquidity from the
BOX Book. The Exchange proposes an amendment to Section 8 of the BOX
Fee Schedule to eliminate the $0.50 per contract fee on Eligible Orders
sent to Away Exchanges. Additionally, the Exchange proposes a
corresponding change to Section 7 so that all Eligible Orders sent to
Away Exchanges are exempt from Section 7 of the BOX Fee Schedule.
Therefore, Eligible Orders sent to Away Exchanges will be subject only
to the applicable transaction fees listed in Sections 1 through 3 of
the BOX Fee Schedule.
---------------------------------------------------------------------------

    \6\ See Securities Exchange Act Release No. 64583 (June 2,
2011), 76 FR 33014 (June 7, 2011) (SR-BX-2011-031). The proposed
change will have no effect on the billing of orders of non-BOX
Options Participants.
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2. Statutory Basis
    The Exchange believes that the proposal is consistent with the
requirements of Section 6(b) of the Act,\7\ in general, and Section
6(b)(4) of the Act,\8\ in particular, in that it provides for the
equitable allocation of reasonable dues, fees, and other charges among
BOX Participants and other persons using its facilities.
---------------------------------------------------------------------------

    \7\ 15 U.S.C. 78f(b).
    \8\ 15 U.S.C. 78f(b)(4).
---------------------------------------------------------------------------

    The Exchange believes that it is equitable to permit BOX
Participants to have orders routed to away exchanges without being
assessed a fee. The Exchange believes that BOX Options Participants may
send additional order flow to BOX, to the benefit of all market
participants, if there is no fee assessed when Participant orders may
be sent to an Away Exchange. The Exchange believes that the proposed
change is an equitable allocation of fees because the order routing fee
structure applies to all BOX Participants.
    Further, the Exchange believes the proposed change and the
resulting order routing fee structure are fair and reasonable and must
be competitive with similar fees in place on other exchanges. BOX
operates within a highly competitive market in which market
participants can readily direct order flow to any of eight other
competing venues if they deem fee levels at a particular venue to be
excessive. The change to allow BOX Participants to have more orders
routed away at no cost is intended to attract order flow to BOX and
provide BOX Participants additional flexibility in their execution
decisions. The Exchange believes all market participants can benefit
from greater liquidity on BOX and that it is appropriate to provide a
fee structure intended to attract additional order flow. In particular,
the proposed change will allow BOX to remain competitive with other
exchanges, and allow BOX to maintain a fee structure which is equitable
among all BOX Participants. The Exchange believes that this competitive
marketplace impacts the fees present on BOX today and influences this
proposal.

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

    The Exchange does not believe that the proposed rule change will
impose any burden on competition not necessary or appropriate in
furtherance of the purposes of the Act.

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

    The Exchange has neither solicited nor received comments on the
proposed rule change.

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A)(ii) of the Act \9\ and Rule 19b-

4(f)(2) thereunder,\10\ because it establishes or changes a due, fee,
or other charge applicable only to a member.
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    \9\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \10\ 17 CFR 240.19b-4(f)(2).
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    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is 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-BX-2011-040 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-BX-2011-040. 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 Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street, NW.,
Washington, DC 20549, on official business days between the hours of 10
a.m. and 3 p.m. Copies of such filing also will be available for
inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-BX-2011-040 and should be
submitted on or before July 27, 2011.
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    \11\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\11\
Cathy H. Ahn,
Deputy Secretary.
[FR Doc. 2011-16823 Filed 7-5-11; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 78, Number 188 (Friday, September 27, 2013)]
[Notices]
[Pages 59735-59738]
[FR Doc No: 2013-23541]

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SECURITIES AND EXCHANGE COMMISSION

[Investment Company Act Release No. 30693; File No. 812-14143]

The KP Funds and Callan Associates Inc., et al.; Notice of
Application

September 23, 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 request an order that would permit
them to enter into and materially amend subadvisory agreements with
Wholly-Owned Subadvisors (as defined below) and non-affiliated
subadvisors without shareholder approval and would grant relief from
certain disclosure requirements.

Applicants: The KP Funds (the ``Trust'') and Callan Associates Inc.
(``Callan'').

Filing Dates: The application was filed on April 3, 2013, and amended
on August 21, 2013 and September 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 October 18, 2013, and should be accompanied by proof of service
on 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:
The Trust, One Freedom Valley Drive, Oaks, PA 19456; and Callan, 101
California Street, Suite 3500, San Francisco, CA 94111.

FOR FURTHER INFORMATION CONTACT: Laura J. Riegel, Senior Counsel, at
(202) 551-6873, or Mary Kay Frech, 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 Trust is organized as a Massachusetts business trust and is
registered under the Act as an open-end management investment company.
The Trust currently intends to offer 14 series (each, a ``Fund'' and
collectively, the ``Funds''), each with its own distinct investment
objectives, policies and restrictions.\1\ Callan is organized as a
California corporation and is registered as an investment adviser under
the Investment Advisers Act of 1940 (``Advisers Act''). Each Fund has,
or will have, as its investment adviser, Callan or another entity
controlling, controlled by or under common control with Callan or its
successors (collectively, the ``Advisor'').\2\ Any future Advisor will
be registered as an investment adviser under the Advisers Act.\3\
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    \1\ The Funds that currently intend to rely on the requested
order are KP Large Cap Equity Fund, KP Small Cap Equity Fund, KP
International Equity Fund, and KP Fixed Income Fund.
    \2\ For purposes of the requested order, ``successor'' is
limited to any entity that results from a reorganization into
another jurisdiction or a change in the type of business
organization.
    \3\ Applicants request that the relief apply to applicants, as
well as to any existing or future series of the Trust and any other
existing or future registered open-end management investment company
or series thereof that: (a) Is advised by the Advisor; (b) uses the
manager of managers structure (``Manager of Managers Structure'')
described in the application, and (c) complies with the terms and
conditions of the application (included in the term ``Funds''). The
only existing registered open-end management investment company that
currently intends to rely on the requested order is named as an
applicant. If the name of any Fund contains the name of a Subadvisor
(as defined below), the name of the Advisor that serves as the
primary adviser to the Fund will precede the name of the Subadvisor.
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    2. Each Fund will enter into an investment advisory agreement with
the Advisor (the ``Advisory Agreement''). The Advisory Agreement with
Callan has been approved by the board of trustees of the Trust (the
``Board''),\4\ including a majority of the members of the Board who are
not ``interested persons,'' as defined in section 2(a)(19) of the Act,
of the Trust, the relevant Fund, or the Advisor (``Independent
Trustees'') and will be approved by the initial shareholder of the
relevant Fund as required by sections 15(a) and 15(c) of the Act and
rule 18f-2 thereunder. The terms of the Advisory Agreement will comply
with section 15(a) of the Act.
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    \4\ The term ``Board'' also includes the board of directors or
trustees of a future Fund.
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    3. Under the terms of the Advisory Agreement, the Advisor, subject
to the authority of the Board, is responsible for the overall
management of a Fund's business affairs and selecting the Fund's
investments in accordance with the Fund's investment objectives,
policies,

and restrictions. For the investment advisory services that it provides
to a Fund, the Advisor receives the fee specified in the Advisory
Agreement based on the Fund's average daily net assets. The Advisory
Agreement also permits the Advisor to enter into investment subadvisory
agreements (``Subadvisory Agreements'') with one or more subadvisors
(each, a ``Subadvisor'') for the purpose of managing a Fund's
investments.\5\ Each Subadvisory Agreement will be approved by the
Board, including by a majority of the Independent Trustees, and the
initial shareholder of the Fund in accordance with sections 15(a) and
15(c) of the Act and rule 18f-2 under the Act. Each Subadvisor is or
will be registered as an investment adviser under the Advisers Act or
not subject to such registration. The Advisor will supervise, evaluate
and allocate assets to the Subadvisors, and make recommendations to the
Board about their hiring, retention or release. The Advisor will
compensate each Subadvisor out of the fee paid to the Advisor under the
Advisory Agreement or the Fund will be responsible for paying
subadvisory fees directly to the Subadvisor.\6\
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    \5\ A ``Subadvisor'' to a Fund is: (a) An indirect or direct
``wholly-owned subsidiary'' (as such term is defined in the Act) of
the Advisor for that Fund; (b) a sister company of the Advisor for
that Fund that is an indirect or direct ``wholly-owned subsidiary''
(as such term is defined in the Act) of the same company that,
indirectly or directly, wholly owns the Advisor (each of (a) and
(b), a ``Wholly-Owned Subadvisor'' and collectively, the ``Wholly-
Owned Subadvisors''); or (c) an investment subadvisor for that Fund
that is not an ``affiliated person'' (as such term is defined in
section 2(a)(3) of the Act) of the Fund or the Advisor, except to
the extent that an affiliation arises solely because the subadvisor
serves as a subadvisor to a Fund (each, a ``Non-Affiliated
Subadvisor'').
    \6\ To the extent a Fund pays subadvisory fees directly from its
assets, any changes to a Subadvisory Agreement that would result in
an increase in the total management and advisory fees payable by the
Fund will be required to be approved by the shareholders of that
Fund.
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    4. Applicants request an order to permit the Advisor, subject to
the approval of the Board, including a majority of the Independent
Trustees, to, without obtaining shareholder approval: (a) Select
Subadvisors to manage all or a portion of the assets of a Fund and
enter into Subadvisory Agreements with the Subadvisors; and (b)
materially amend Subadvisory Agreements with the Subadvisors.\7\ The
requested relief will not extend to any subadvisor, other than a
Wholly-Owned Subadvisor, who is an affiliated person, as defined in
section 2(a)(3) of the Act, of the Fund or the Advisor, other than by
reason of serving as a subadvisor to one or more of the Funds
(``Affiliated Subadvisor'').
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    \7\ Shareholder approval will continue to be required for any
other subadvisor change (not otherwise permitted by rule or other
action of the Commission or its staff) and material amendments to an
existing Subadvisory Agreement with any subadvisor other than a Non-
Affiliated Subadvisor or a Wholly-Owned Subadvisor (all such changes
referred to as ``Ineligible Subadvisor Changes'').
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    5. Funds will inform shareholders of the hiring of a new Subadvisor
pursuant to the following procedures (``Modified Notice and Access
Procedures''): (a) Within 90 days after a new Subadvisor is hired for
any Fund, that Fund will send its shareholders either a Multi-manager
Notice or a Multi-manager Notice and Multi-manager Information
Statement; \8\ 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.
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    \8\ A ``Multi-manager Notice'' will be modeled on a Notice of
Internet Availability as defined in rule 14a-16 under the Securities
Exchange Act of 1934 (``Exchange Act''), and specifically will,
among other things: (a) Summarize the relevant information regarding
the new Subadvisor; (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 Fund.
    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 order to permit Aggregate Fee Disclosure (as defined
below). Multi-manager Information Statements will be filed with the
Commission via the EDGAR system.
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    6. Applicants also request an order exempting the Funds from
certain disclosure obligations that may require each Fund to disclose
fees paid by the Advisor to each Subadvisor. Applicants seek relief to
permit each Fund to disclose (both as a dollar amount and as a
percentage of the Fund's net assets): (a) The aggregate fees paid to
the Advisor and any Wholly-Owned Subadvisors; and (b) the aggregate
fees paid to Non-Affiliated Subadvisors (collectively, the ``Aggregate
Fee Disclosure''). The Aggregate Fee Disclosure for a Fund also will
include separate disclosure of any subadvisory fees paid to any
Affiliated Subadvisor.

Applicants' Legal Analysis

    1. Section 15(a) of the Act states, in 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, which
contract, whether with such registered company or with an investment
adviser of such registered company, has been approved by the vote of a
majority of the outstanding voting securities of such registered
company.'' 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
management investment companies. Item 19(a)(3) of Form N-1A requires a
registered open-end management investment company to disclose in its
statement of additional information, with respect to each investment
adviser, the method of calculating the advisory fee payable by the
investment company, including the total dollar amounts paid to each
adviser for the last three fiscal years.
    3. Rule 20a-1 under the Act requires proxies solicited with respect
to a registered investment company to comply with Schedule 14A under
the 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 fee,'' 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 statement
information about the investment advisory fees.
    5. Section 6(c) of the Act provides that the Commission by order
upon application may conditionally or unconditionally 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 their requested relief meets this standard for the reasons
discussed below.
    6. Applicants assert that the shareholders expect the Advisor,
subject to the review and approval of the Board, to select the
Subadvisors who are in the best position to achieve the Fund's
investment objective. Applicants assert that, from the perspective of
the shareholder, the role of the Subadvisor is substantially equivalent
to the role of the individual portfolio managers employed by an
investment adviser to a traditional investment company. Applicants
believe that permitting the Advisor to perform the duties for which the
shareholders of the Funds are paying the Advisor--the selection,
supervision and evaluation of the Subadvisors--without incurring
unnecessary delays or expenses is appropriate in the interest of the
Fund's shareholders and will allow such Funds to operate more
efficiently. Applicants state that each Advisory Agreement will
continue to be fully subject to section 15(a) of the Act and rule 18f-2
under the Act.
    7. Applicants assert that disclosure of the individual fees that
the Advisor would pay to the Subadvisors of Funds that operate under
the Manager of Managers Structure would not serve any meaningful
purpose. Applicants contend that the primary reasons for requiring
disclosure of individual fees paid to Subadvisors are to inform
shareholders of expenses to be charged by a particular Fund and to
enable shareholders to compare the fees to those of other comparable
investment companies. Applicants believe that the requested relief
satisfies these objectives because the advisory fee paid to the Advisor
will be fully disclosed and, therefore, shareholders will know what the
Funds' fees and expenses are and will be able to compare the advisory
fees a Fund is charged to those of other investment companies.
Applicants assert that the requested disclosure relief would benefit
shareholders of the Funds because it would improve the Advisor's
ability to negotiate the fees paid to Subadvisors. Applicants state
that the Advisor may be able to negotiate rates that are below a
Subadvisor's ``posted'' amounts if the Advisor is not required to
disclose the Subadvisors' fees to the public. Applicants submit that
the relief requested to use Aggregate Fee Disclosure will encourage
Subadvisors to negotiate lower subadvisory 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 requested order, the operation of
the Fund in the manner described in the application, including the
hiring of Wholly-Owned Subadvisors, 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 that
Fund's shares to the public.
    2. Each Fund relying on the requested order will disclose in its
prospectus, the existence, substance, and effect of any order granted
pursuant to the application. Each Fund will hold itself out to the
public as utilizing the Manager of Managers Structure. The prospectus
will prominently disclose that the Advisor has ultimate responsibility
(subject to oversight by the Board) to oversee the Subadvisors and
recommend their hiring, termination, and replacement.
    3. A Fund will inform shareholders of the hiring of a new
Subadvisor within 90 days after the hiring of the new Subadvisor
pursuant to the Modified Notice and Access Procedures.
    4. A Fund will not make any Ineligible Subadvisor Changes without
the approval of the shareholders of the applicable Fund.
    5. At all times, at least a majority of the Board will be
Independent Trustees, and the selection and nomination of new or
additional Independent Trustees will be placed within the discretion of
the then-existing Independent Trustees.
    6. Whenever a subadvisor change is proposed for a Fund with an
Affiliated Subadvisor or a Wholly-Owned Subadvisor, 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
Subadvisor or Wholly-Owned Subadvisor derives an inappropriate
advantage.
    7. 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.
    8. The Advisor will provide general management services to a Fund,
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: (a) Set a Fund's overall investment strategies; (b)
evaluate, select and recommend Subadvisors to manage all or a part of a
Fund's assets; (c) allocate and, when appropriate, reallocate a Fund's
assets among one or more Subadvisors; (d) monitor and evaluate the
performance of Subadvisors; and (e) implement procedures reasonably
designed to ensure that the Subadvisors comply with a Fund's investment
objective, policies and restrictions.
    9. No trustee or officer of a Trust or of a Fund, 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 subadvisor to a Fund, 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
Subadvisor or an entity that controls, is controlled by, or is under
common control with a Subadvisor.
    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. For any Fund that pays subadvisory fees directly from its
assets, any changes to a Subadvisory Agreement that would result in an
increase in the total management and advisory fees payable by the Fund
will be required to be approved by the shareholders of that Fund.
    13. Whenever a subadvisor is hired or terminated, the Advisor will
provide the Board with information showing the expected impact on the
profitability of the Advisor.
    14. 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 subadvisor during the
applicable quarter.

    For the Commission, by the Division of Investment Management,
under delegated authority.
Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2013-23541 Filed 9-26-13; 8:45 am]
BILLING CODE 8011-01-P