[Federal Register Volume 78, Number 223 (Tuesday, November 19, 2013)]
[Notices]
[Pages 69412-69413]
[FR Doc No: 2013-27676]

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ENVIRONMENTAL PROTECTION AGENCY

[FRL-9903-04-OCFO]

Draft FY 2014-2018 EPA Strategic Plan; Availability

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of availability, request for public comments.

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SUMMARY: The U.S. Environmental Protection Agency (EPA) is announcing
the availability of the Draft FY 2014-2018 EPA Strategic Plan for
public review and comment, as part of the periodic update required by
the Government Performance and Results Act (GPRA) Modernization Act of
2010 (Pub. L. 111-352). The agency anticipates the final Strategic Plan
will be submitted to Congress in February 2014. The Strategic Plan
provides the Agency's long-term direction and strategies for advancing
human health and the environment. For this notice, the EPA is seeking
comment from individual citizens, states, tribes, local government,
industry, the academic community, non-governmental organizations, and
all other interested parties. The agency is particularly interested in
feedback addressing strategies contained in the goal narratives, cross-
cutting fundamental strategies, and strategic measures. The agency made
targeted revisions to our existing Plan that seek to advance efforts to
address our changing climate, protect our precious water and land
resources, and advance chemical safety. The Plan seeks to outline how
EPA will make a visible difference in communities across the country by
advancing sustainability, innovation and providing sound scientific
advice, technical and compliance assistance and other tools that
support states, tribes, cities, towns, rural communities, and the
private sector. Under this Plan, EPA will continue to improve the way
we do business, engaging closely with our public sector partners at all
levels and the regulated community to achieve environmental benefits in
the most pragmatic, collaborative, and flexible way possible--for our
children and future generations.
    In addition, the EPA is proposing new FY 2014-2015 Agency Priority
Goals--a key component of the

Administration's performance management system--to align more closely
with our highest priorities, including improving the health of
communities across the country and tackling the issue of climate
change.

DATES: Comments must be received on or before January 3, 2014.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-OA-
2013-0555, by one of the following methods (electronic submission
preferred):
    Electronic: Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
    Fax: ATTN: Vivian Daub, Director, Planning Staff, Fax number: (202)
564-1808.
    Mail: ATTN: Vivian Daub, Director, Planning Staff, Office of
Planning, Analysis, and Accountability (Mail Code 2723A), Office of the
Chief Financial Officer, U.S. Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington, DC 20460.
    Important: Please allow a minimum of two weeks from date postmarked
to allow ample time for receipt.

FOR FURTHER INFORMATION CONTACT: Vivian Daub, Director, Planning Staff,
Office of Planning, Analysis, and Accountability, Office of the Chief
Financial Officer<EMAIL_ADDRESS>    Instructions: EPA's policy is that all comments received will be
included in the public docket without change and may be made available
online at www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through www.regulations.gov
or email. The www.regulations.gov Web site is an ``anonymous access''
system, which means EPA will not know your identity or contact
information unless you provide it in the body of your comment. If you
send an email comment directly to EPA without going through
www.regulations.gov your email address will be automatically captured
and included as part of the comment that is placed in the public docket
and made available on the Internet. If you submit an electronic
comment, EPA recommends that you include your name and other contact
information in the body of your comment and with any disk or CD-ROM you
submit. If EPA cannot read your comment due to technical difficulties
and cannot contact you for clarification, EPA may not be able to
consider your comment. Electronic files should avoid the use of special
characters, any form of encryption, and be free of any defects or
viruses. For additional information about EPA's public docket visit the
EPA Docket Center homepage at http://www.epa.gov/dockets/.

SUPPLEMENTARY INFORMATION:

Background

    The GPRA Modernization Act holds federal agencies accountable for
using resources wisely and achieving program results. Specifically, the
GPRA Modernization Act requires agencies to develop: Strategic Plans,
which include a mission statement, set out long-term goals, objectives,
and strategic measures, and describe strategies to achieve them over a
four-year time horizon; Annual Performance Plans, which provide annual
performance measures and activities toward the long-term Strategic
Plan; and, Annual Performance Reports, which evaluate an agency's
success in achieving the annual performance measures.
    The Draft FY 2014-2018 EPA Strategic Plan reflects the
Administrator's themes for advancing EPA's mission. The Plan presents
five strategic goals to accelerate protection of human health and the
environment and four cross-cutting fundamental strategies for changing
the way the agency does business in achieving its results. The five
strategic goals are: Addressing Climate Change and Improving Air
Quality; Protecting America's Waters; Cleaning Up Communities and
Advancing Sustainable Development; Ensuring the Safety of Chemicals and
Preventing Pollution; and Protecting Human Health and the Environment
by Enforcing Laws and Assuring Compliance. The four cross-cutting
fundamental strategies are: Working Toward a Sustainable Future;
Working to Make a Visible Difference in Communities; Launching a New
Era of State, Tribal, Local, and International Partnerships; and
Embracing EPA as a High-Performing Organization. The Strategic Plan
also identifies a suite of strategic measures by which the agency will
hold itself accountable.

Maryann Froehlich,
Acting Chief Financial Officer, Office of the Chief Financial Officer.
[FR Doc. 2013-27676 Filed 11-18-13; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 76, Number 209 (Friday, October 28, 2011)]
[Notices]
[Pages 67015-67017]
[FR Doc No: 2011-27936]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-65605; File No. SR-PHLX-2011-140]

Self-Regulatory Organizations; NASDAQ OMX PHLX LLC; Notice of
Filing of Proposed Rule Change To Amend the By-Laws of The NASDAQ OMX
Group, Inc.

October 21, 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 October 11, 2011, NASDAQ OMX PHLX LLC (``PHLX'' or ``Exchange'')
filed with the Securities and Exchange Commission (``Commission'') the
proposed rule change as described in Items I, II, and III below, which
Items have been prepared by the Exchange. The Commission is publishing
this notice to solicit comments on the proposed rule change from
interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    PHLX is filing this proposed rule change with respect to an
amendment to the by-laws of its parent corporation, The NASDAQ OMX
Group, Inc. (``NASDAQ OMX''). The text of the proposed rule change is
available on the Exchange's Web site at http://nasdaqomxphlx.cchwallstreet.com, at the principal office of the
Exchange, and at the Commission's Public Reference Room. The proposed
amendments will be implemented upon approval by the Commission.

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

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

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

1. Purpose
    NASDAQ OMX is proposing amendments to provisions of its by-laws
pertaining to the composition of committees of the NASDAQ OMX Board of
Directors. First, NASDAQ OMX is amending the compositional requirements
of its Audit Committee in Section 4.13(g) to provide that the committee
shall include three or more directors. Currently, the provision
provides that the Audit Committee shall be composed of either four or
five directors. The change will provide the NASDAQ OMX Board of
Directors, which has authority to establish the size of each committee
of the Board of Directors, with flexibility to increase or decrease the
size of the committee, as long as the committee includes at least three
directors. The listing standards of the NASDAQ Stock Market, which
apply to NASDAQ OMX as a listed company, require that NASDAQ OMX's
Audit Committee must have at least three members.\3\ The amendment
would not change any of the other compositional requirements of the
Audit Committee, including independence requirements.
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    \3\ NASDAQ IM-4605-3. [sic]
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    Similarly, NASDAQ OMX is proposing to amend the compositional
requirements of the Nominating & Governance Committee in Section
4.13(h) to replace a requirement that the committee comprise four or
five members with a requirement to include two or more members, thereby
creating flexibility to populate a larger or a

smaller committee than is currently the case. NASDAQ Stock Market
listing standards do not regulate the size of a listed company's
nominating committee. The amendment would not change any of the other
compositional requirements of the Nominating & Governance Committee,
including independence requirements.
    PHLX expects that the NASDAQ OMX Board of Directors will, in the
immediate future, use the modified authority to increase the size of
the Nominating & Governance Committee to six directors, but will not
modify the size of the Audit Committee at this time. It is likely that
the authority would be used to reduce the size of these committees
below their current levels only in the event of a reduction in the
overall size of the NASDAQ OMX Board of Directors (which currently has
16 members). The Audit Committee supervises the audit function with
respect to NASDAQ OMX and all of its subsidiaries, including PHLX, but
the Nominating & Governance Committee does not perform a nominating
function with respect to NASDAQ OMX's subsidiaries.
    Third, NASDAQ OMX proposes to delete a paragraph of the by-laws
(Section 4.13(k)) that pertains to the qualifications of committee
members who are not directors. This provision was originally adopted by
NASDAQ OMX's predecessor corporation, The Nasdaq Stock Market, Inc.,
when it was a subsidiary and facility of the National Association of
Securities Dealers, Inc. (``NASD''). In that capacity, The Nasdaq Stock
Market, Inc. appointed committees that included non-directors and that
exercised authority provided for under NASD rules. For example, at that
time, the Board of Directors of The Nasdaq Stock Market, Inc. appointed
the Nasdaq Listing and Hearing Review Council, a committee composed of
non-directors with authority to review listing decisions with respect
to companies with securities listed on The Nasdaq Stock Market, which
was then a facility of NASD.
    In 2005, The NASDAQ Stock Market LLC (``NASDAQ'') was formed as a
subsidiary [sic] The Nasdaq Stock Market, Inc., and in 2006, NASDAQ was
registered as a national securities exchange. The Nasdaq Stock Market,
Inc., which had already issued stock to the public, became a holding
company, and in 2007, it ceased operating as a facility of NASD or
NASDAQ. Subsequently, following the acquisition of OMX AB, The Nasdaq
Stock Market, Inc. became NASDAQ OMX. As a public holding company,
NASDAQ OMX no longer appoints committees that include non-directors.
Accordingly, the provision with respect to the qualifications of non-
directors is obsolete and may appropriately be deleted.
    Finally, NASDAQ OMX is correcting a typographical error in the
numbering of the provisions of Section 4.13(h) of the by-laws.
2. Statutory Basis
    PHLX believes that the proposed rule change is consistent with the
provisions of Section 6 of the Act,\4\ in general, and with Sections
6(b)(1) and (b)(5) of the Act,\5\ in particular, in that the proposal
enables PHLX to be so organized and to have the capacity to be able to
carry out the purposes of the Act and to comply with and enforce
compliance by members and persons associated with members with
provisions of the Act, the rules and regulations thereunder, and PHLX
rules, and is designed to prevent fraudulent and manipulative acts and
practices, to promote just and equitable principles of trade, to foster
cooperation and coordination with persons engaged in regulating,
clearing, settling, processing information with respect to, and
facilitating transactions in securities, to remove impediments to and
perfect the mechanism of a free and open market and a national market
system, and, in general, to protect investors and the public interest.
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    \4\ 15 U.S.C. 78f.
    \5\ 15 U.S.C. 78f(b)(1), (5).
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    PHLX believes that the proposed amendments are non-controversial.
The proposal to modify the compositional requirements of the NASDAQ OMX
Audit Committee and Nominating & Governance Committee will provide the
NASDAQ OMX Board of Directors with greater flexibility to determine the
appropriate size for these committees, while maintaining compliance
with applicable listing standards. PHLX expects that the NASDAQ OMX
Board of Directors will, in the immediate future, use the modified
authority to increase the size of the Nominating & Governance Committee
to six directors, but will not modify the size of the Audit Committee
at this time. The proposed changes also delete an obsolete provision
from the by-laws and correct a typographical error.

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

    No written comments were either solicited or received.

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

    Within 45 days of the date of publication of this notice in the
Federal Register or within such longer period (i) As the Commission may
designate up to 90 days of such date if it finds such longer period to
be appropriate and publishes its reasons for so finding or (ii) as to
which the self-regulatory organization consents, the Commission shall:
(a) By order approve or disapprove such proposed rule change, or (b)
institute proceedings to determine whether the proposed rule change
should be disapproved.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-PHLX-2011-140 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-PHLX-2011-140. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the

public in accordance with the provisions of 5 U.S.C. 552, will be
available for Web site viewing and printing in the Commission's Public
Reference Room, 100 F Street, NE., Washington, DC 20549, on official
business days between the hours of 10 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 publicly available. All submissions should refer to
File Number SR-PHLX-2011-140 and should be submitted on or before
November 18, 2011.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\6\
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    \6\ 17 CFR 200.30-3(a)(12).
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Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2011-27936 Filed 10-27-11; 8:45 am]
BILLING CODE 8011-01-P


U. S. EPA BOARD OF SCIENTIFIC COUNSELORS Mercury Subcommittee DRAFT AGENDA Face to Face Meeting February 23 24, 2005 Holiday Inn Rosslyn 1900 N. Fort Myer Drive Arlington, VA Wednesday, February 23 7: 30 Breakfast Meet and Greet 9: 00 Welcome & Introductions Herb Windom, Chair FACA Housekeeping Heather Drumm, DFO 9: 30 Agency Perspective   How Mercury Research fits into regulatory support. Jeff Morris or Kevin Teichman ( OSP)/ Carl Mazza or Jason Burnett ( OAR)

10: 00 BREAK 10: 15 Presentation on Fate and Transport Bill Stelz, NCER Michele Aston, NERL 11: 00 Presentation on Combustion Doug McKinney, NRMRL Combustion Team 11: 40 Presentation on Health Effects Rita Schoeny 12: 00 Public Comments 12: 15 LUNCH 1: 15 Writing Period  breakout into groups based on charge questions 5: 00 Adjourn Thursday, February 24 8: 30 Summary of Previous Days Events Herb Windom 8: 45 Report back on results of writing assignment.

9: 45 Additional Writing and Editing of Letter Report 10: 15 BREAK 10: 30 Distribution and Discussion of Letter Report 11: 30 Next Steps Herb Windom Noon Adjourn


[Federal Register Volume 81, Number 123 (Monday, June 27, 2016)]
[Notices]
[Pages 41625-41626]
[FR Doc No: 2016-15214]

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SECURITIES AND EXCHANGE COMMISSION

[File No. 500-1]

In the Matter of Caspian International Oil Corporation, Elevate,
Inc., Frawley Corporation, Groen Brothers Aviation, Inc., and Logic
Devices, Incorporated; Order of Suspension of Trading

June 23, 2016.
    It appears to the Securities and Exchange Commission
(``Commission'') that there is a lack of current and accurate
information concerning the securities of Caspian International Oil
Corporation (``CIOC \1\'') (CIK No. 816958), a void Delaware
corporation located in Houston, Texas with a class of securities
registered with the Commission pursuant to Securities Exchange Act of
1934 (``Exchange Act'') Section 12(g) because it is delinquent in its
periodic filings with the Commission, having not filed any periodic
reports since it filed a Form 10-Q for the period ended September 30,
2008. On April 12, 2011, the Commission's Division of Corporation
Finance (``Corporation Finance'') sent a delinquency letter to CIOC
requesting compliance with its periodic filing requirements but CIOC
did not receive the delinquency letter due to its failure to maintain a
valid address on file with the Commission as required by Commission
rules (Rule 301 of Regulation S-T, 17 CFR 232.301 and Section 5.4 of
EDGAR Filer Manual) (``Commission Issuer Address Rules''). As of June
16, 2016, the common stock of CIOC was quoted on OTC Link operated by
OTC Markets Group Inc. (formerly ``Pink Sheets'') (``OTC Link''), had
two market makers, and was eligible for the ``piggyback'' exception of
Exchange Act Rule 15c2-11(f)(3).
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    \1\ The short form of each issuer's name is also its stock
symbol.
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    It appears to the Commission that there is a lack of current and
accurate information concerning the securities of Elevate, Inc.
(``ELEV'') (CIK No. 1424415), a defaulted Nevada corporation located in
San Clemente, California with a class of securities registered with the
Commission pursuant to Exchange Act Section 12(g) because it is
delinquent in its periodic filings with the Commission, having not
filed any periodic reports since it filed a Form 10-Q for the period
ended February 29, 2012. On January 28, 2016, Corporation Finance sent
a delinquency letter to ELEV requesting compliance with its periodic
filing requirements but ELEV did not receive the delinquency letter due
to its failure to maintain a valid address on file with the Commission
as required by Commission Issuer Address Rules. As of June 16, 2016,
the common stock of ELEV was quoted on OTC Link, had six market makers,
and was eligible for the ``piggyback'' exception of Exchange Act Rule
15c2-11(f)(3).
    It appears to the Commission that there is a lack of current and
accurate information concerning the securities of Frawley Corporation
(``FRWL'') (CIK No. 38824), a void Delaware corporation located in
Agoura Hills, California with a class of securities registered with the
Commission pursuant to Exchange Act Section 12(g) because it is
delinquent in its periodic filings with the Commission, having not
filed any periodic reports since it filed a Form 10-K for the period
ended December 31, 2011. On November 21, 2011, Corporation Finance sent
a delinquency letter to FRWL requesting compliance with its periodic
filing requirements but FRWL did not receive the delinquency letter due
to its failure to maintain a valid address on file with the Commission
as required by Commission Issuer Address Rules. As of June 16, 2016,
the common stock of FRWL was quoted on OTC Link, had four market
makers, and was eligible for the ``piggyback'' exception of Exchange
Act Rule 15c2-11(f)(3).
    It appears to the Commission that there is a lack of current and
accurate information concerning the securities of Groen Brothers
Aviation, Inc. (``GNBA'') (CIK No. 870743), an expired Utah corporation
located in Salt Lake City, Utah with a class of securities registered
with the Commission pursuant to Exchange Act Section 12(g) because it
is delinquent in its periodic filings with the Commission, having not
filed any periodic reports since it filed a Form 10-K for the period
ended June 30,

2012. On February 22, 2016, Corporation Finance sent a delinquency
letter to GNBA requesting compliance with its periodic filing
requirements but GNBA did not receive the delinquency letter due to its
failure to maintain a valid address on file with the Commission as
required by Commission Issuer Address Rules. As of June 16, 2016, the
common stock of GNBA was quoted on OTC Link, had five market makers,
and was eligible for the ``piggyback'' exception of Exchange Act Rule
15c2-11(f)(3).
    It appears to the Commission that there is a lack of current and
accurate information concerning the securities of Logic Devices,
Incorporated (``LOGC'') (CIK No. 802851), a suspended California
corporation located in Sunnyvale, California with a class of securities
registered with the Commission pursuant to Exchange Act Section 12(g)
because it is delinquent in its periodic filings with the Commission,
having not filed any periodic reports since it filed a Form 10-Q for
the period ended June 30, 2012. On November 14, 2013, Corporation
Finance sent a delinquency letter to LOGC requesting compliance with
its periodic filing requirements but LOGC did not receive the
delinquency letter due to its failure to maintain a valid address on
file with the Commission as required by Commission Issuer Address
Rules. As of June 16, 2016, the common stock of LOGC was quoted on OTC
Link, had five market makers, and was eligible for the ``piggyback''
exception of Exchange Act Rule 15c2-11(f)(3).
    The Commission is of the opinion that the public interest and the
protection of investors require a suspension of trading in the
securities of the above-listed companies. Therefore, it is ordered,
pursuant to Section 12(k) of the Securities Exchange Act of 1934, that
trading in the securities of the above-listed companies is suspended
for the period from 9:30 a.m. EDT on June 23, 2016, through 11:59 p.m.
EDT on July 7, 2016.

    By the Commission.
Jill M. Peterson,
Assistant Secretary.
[FR Doc. 2016-15214 Filed 6-23-16; 11:15 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 87, Number 103 (Friday, May 27, 2022)]
[Notices]
[Pages 32172-32174]
[FR Doc No: 2022-11420]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-N-0589]

General and Plastic Surgery Devices Panel of the Medical Devices
Advisory Committee; Notice of Meeting; Establishment of a Public
Docket; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; establishment of a public docket; request for comments.

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SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming
public advisory committee meeting of the General and Plastic Surgery
Devices Panel of the Medical Devices Advisory Committee. The general
function of the committee is to provide advice and recommendations to
FDA on regulatory issues. The meeting will be open to the public. FDA
is establishing a docket for public comment on this document.

DATES: The meeting will be held virtually on July 28, 2022, from 9 a.m.
to 5:45 p.m. Eastern Time and July 29, 2022, from 9 a.m. to 4 p.m.
Eastern Time.

ADDRESSES: Please note that due to the impact of the COVID-19 pandemic,
all meeting participants will be joining this advisory committee
meeting via an online teleconferencing platform. Answers to commonly
asked questions, including information regarding special accommodations
due to a disability, may be accessed at: https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.
    FDA is establishing a docket for public comment on this meeting.
The docket number is FDA-2022-N-0589. The docket will close on August
29, 2022. Submit either electronic or written comments on this public
meeting by August 29, 2022. Please note that late, untimely filed
comments will not be considered. Electronic comments must be submitted
on or before August 29, 2022. The https://www.regulations.gov
electronic filing system will accept comments until 11:59 p.m. Eastern
Time at the end of August 29, 2022. Comments received by mail/hand
delivery/courier (for written/paper submissions) will be considered
timely if they are postmarked or the delivery service acceptance
receipt is on or before that date.
    Comments received on or before July 11, 2022, will be provided to
the committee. Comments received after that date will be taken into
consideration by FDA. In the event that the meeting is cancelled, FDA
will continue to evaluate any relevant applications or information, and
consider any comments submitted to the docket, as appropriate.
    You may submit comments 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-2022-N-0589 for ``General and Plastic Surgery Devices Panel of the
Medical Devices Advisory Committee; Notice of Meeting; Establishment of
a Public Docket; Request for Comments.'' Received comments, those filed
in a timely manner (see ADDRESSES), will be placed in the docket and,
except for those submitted as ``Confidential Submissions,'' publicly
viewable at https://www.regulations.gov or at the Dockets Management
Staff between 9 a.m. and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' FDA 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 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 the information as ``confidential.'' Any
information marked as ``confidential'' will not be disclosed except in
accordance with 21 CFR 10.20 and other applicable disclosure law. For
more information about FDA's posting of comments to public dockets, see
80 FR 56469, September 18, 2015, or access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Candace Nalls, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5216, Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
[email protected], or FDA Advisory Committee Information Line,
1-800-741-8138<PHONE_NUMBER> in the Washington, DC area). A notice in
the Federal Register about last minute modifications that impact a
previously announced advisory committee meeting cannot always be
published quickly enough to provide timely notice. Therefore, you
should always check the FDA's website at https://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate
advisory committee meeting link, or call the advisory committee
information line to learn about possible modifications before the
meeting.

SUPPLEMENTARY INFORMATION:
    Agenda: On July 28, 2022, the committee will discuss the topic of
skin lesion analyzer technology and its application to detecting skin
cancers in various patient care settings. The skin lesion analyzer
devices on which the discussion is focused at this meeting are
algorithm-based devices for adjunctive detection of various skin
lesions, including skin cancers. We will refer to these computer
algorithm-aided devices for adjunctive detection of lesions suspicious
for skin cancers as Skin Lesion Analyzers (SLAs). In recent years, FDA
has seen an increased interest in the development of skin lesion
analyzers that employ artificial intelligence and machine learning.
These devices include a range of technologies and intended user
populations. FDA is interested in the committee members' perspectives
on approaches for evaluating the performance of SLA devices given the
heterogeneity of technologies and indications.
    FDA is convening this committee to promote an open public
discussion of, and seek expert opinion on, currently available
scientific and clinical data pertaining to the diagnosing standard also
known as ground truth, performance criteria, and patient population in
future studies assisting medical providers in properly identifying skin
lesions by a computer algorithm-aided device. The committee will be
asked to discuss and provide recommendations regarding:
     The diagnosing standard, or ground truth, based on factual
data that should be used as a comparison for the performance of
diagnostic devices including, but not limited to, histology, consensus
opinion of a panel of dermatologists, opinion of a single
dermatologist, or other means.
     Acceptable thresholds for sensitivity and specificity
based on the target diagnosis (melanoma, basal cell carcinoma (BCC),
squamous cell carcinoma (SCC)), or on the intended user (dermatologist,
primary care physician, lay user) if assessed for standalone
performance.
     Patient characteristics, including lower or higher
incidence populations, that should be tested before marketing.
     Balance of increased access with risk mitigation measures
that are appropriate when the devices are used by lay people, by
populations with very high or very low incidence of melanoma, by
populations with low incidence, but high mortality associated with
melanoma, or by the target diagnosis/lesion type (melanoma, BCC, SCC)
    On July 29, 2022, the committee will discuss the possible
reclassification of approved computer-aided melanoma detection class
III devices: (1) MelaFind, a device that uses multispectral imaging and
was approved in 2012 (P090012; https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=p090012), and (2) Nevisense, a device that
measures impedance and was approved in 2017 (P150046; https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P150046).

Both Melafind and Nevisense devices are intended for use on cutaneous
lesions suspicious for melanoma when a dermatologist chooses to obtain
additional information when considering biopsy. The committee will
discuss if there is sufficient information to reclassify computer-aided
devices for adjunctive diagnostic information of lesions suspicious for
melanoma from class III to class II, and what special controls may be
appropriate to provide reasonable assurance of safety and effectiveness
for these devices if they are reclassified as class II devices.
    FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its website prior to the meeting, the
background material will be made publicly available on FDA's website
after the meeting. Background material is available at https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the
appropriate advisory committee meeting link. The meeting will include
slide presentations with audio components to allow the presentation of
materials in a manner that most closely resembles an in-person advisory
committee meeting.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
All electronic and written submissions submitted to the Docket (see
ADDRESSES) on or before July 11, 2022, will be provided to the panel.
Oral presentations from the public will be scheduled on July 28, 2022,
between approximately 1 p.m. and 2 p.m. Eastern Time, and on July 29,
2022, between approximately 1 p.m. and 2 p.m. Eastern Time. Those
individuals interested in making formal oral presentations should
notify the contact person and submit a brief statement of the general
nature of the evidence or arguments they wish to present, the names and
addresses of proposed participants, and an indication of the
approximate time requested to make their presentation on or before June
28, 2022. Time allotted for each presentation may be limited. If the
number of registrants requesting to speak is greater than can be
reasonably accommodated during the scheduled open public hearing
session, FDA may conduct a lottery to determine the speakers for the
scheduled open public hearing session. The contact person will notify
interested persons regarding their request to speak by June 29, 2022.
    For press inquiries, please contact the Office of Media Affairs at
[email protected] or<PHONE_NUMBER>.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
disabilities. If you require accommodations due to a disability, please
contact Artair Mallett, at [email protected] or<PHONE_NUMBER>,
at least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our website at https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: May 19, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-11420 Filed 5-26-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 88, Number 226 (Monday, November 27, 2023)]
[Notices]
[Pages 82906-82907]
[FR Doc No: 2023-26044]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-2894]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Good Laboratory
Practice Requirements for Nonclinical Laboratory Studies

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA, we, or the Agency) is
announcing that a proposed collection of information has been submitted
to the Office of Management and Budget (OMB) for review and clearance
under the Paperwork Reduction Act of 1995.

DATES: Submit written comments (including recommendations) on the
collection of information by December 27, 2023.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0119. Also include the FDA docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Good Laboratory Practice Requirements for Nonclinical Laboratory
Studies--21 CFR Part 58

OMB Control Number 0910-0119--Extension

    Sections 409, 505, 512, and 515 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 348, 355, 360b, and 360e) and related statutes
require manufacturers of food additives, human drugs and biological
products, animal drugs, and medical devices to demonstrate the safety
and utility of their product by submitting applications to FDA for
research or marketing permits. Such applications contain, among other
important items, full reports of all studies done to demonstrate
product safety in man and/or other animals. In order to ensure adequate
quality control for these studies and to provide an adequate degree of
consumer protection, the Agency issued good laboratory practice (GLP)
regulations for nonclinical laboratory studies in part 58 (21 CFR part
58). The regulations specify minimum standards for the proper conduct
of safety testing and contain sections on facilities, personnel,
equipment, standard operating procedures (SOPs), test and control
articles, quality assurance, protocol and conduct of a safety study,
records and reports, and laboratory disqualification, and include
information collection provisions.
    Part 58 requires testing facilities engaged in conducting
toxicological studies to retain, and make available to regulatory
officials, records regarding compliance with GLPs. Records are
maintained on file at each testing facility and examined there
periodically by FDA inspectors. The GLP regulations require that, for
each nonclinical laboratory study, a final report be prepared that
documents the results of quality assurance unit inspections, test and
control article characterization, testing of mixtures of test and
control articles with carriers, and an overall interpretation of
nonclinical laboratory studies. The GLP regulations also require
written records pertaining to: (1) personnel job descriptions and
summaries of training and experience; (2) master schedules, protocols
and amendments thereto, inspection reports, and SOPs; (3) equipment
inspection, maintenance, calibration, and testing records; (4)
documentation of feed and water analyses and animal treatments; (5)
test article accountability records; and (6) study documentation and
raw data.
    Description of Respondents: Respondents to the collection of
information are sponsors of nonclinical laboratory studies that support
or are intended to support applications for research or marketing
permits for products regulated by FDA.
    In the Federal Register of August 8, 2023 (88 FR 53492), we
published a 60-day notice soliciting comment on the proposed collection
of information. One comment was received underscoring the critical
nature of language translations in information exchange between
international communities but did not suggest any modifications to our
burden estimates.
    We estimate the burden of this collection of information as
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of
         21 CFR section              Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
----------------------------------------------------------------------------------------------------------------
Sec.   58.35(b)(7); Quality                  300           60.25          18,075               1          18,075
 assurance unit.................
Sec.   58.185; Reporting of                  300           60.25          18,075           27.65         499,774
 nonclinical laboratory study
 results........................
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............         517,849
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

                                                    Table 2--Estimated Annual Recordkeeping Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                  Number of
                21 CFR section                    Number of      records per    Total annual        Average burden per recordkeeping        Total hours
                                                recordkeepers   recordkeeper       records
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sec.   58.29(b); Personnel...................             300              20           6,000  .21 (13 minutes).........................           1,260
Sec.   58.35(b)(1)-(6), and (c); Quality                  300          270.76          81,228  3.36.....................................         272,926
 assurance unit.
Sec.   58.63(b) and (c); Maintenance and                  300              60          18,000  .09 (5 minutes)..........................           1,620
 calibration of equipment.
Sec.   58.81(a)-(c); SOPs....................             300          301.80          90,540  .14 (8 minutes)..........................          12,676
Sec.   58.90(c) and (g); Animal care.........             300           62.70          18,810  .13 (8 minutes)..........................           2,445
Sec.   58.105(a) and (b); Test and control                300               5           1,500  11.8.....................................          17,700
 article characterization.
Sec.   58.107(d); Test and control article                300               1             300  4.25.....................................           1,275
 handling.
Sec.   58.113(a); Mixtures of articles with               300           15.33           4,599  6.8......................................          31,273
 carriers.
Sec.   58.120; Protocol......................             300           15.38           4,614  32.7.....................................         150,878
Sec.   58.195; Retention of records..........             300          251.50          75,450  3.9......................................         294,255
                                              ----------------------------------------------------------------------------------------------------------
    Total....................................  ..............  ..............  ..............  .........................................         786,308
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Based on an evaluation of the information collection, we are
retaining the currently approved estimates. Our assumptions made
regarding the time needed for the respective activities is based on our
experience with the information collection and informal communications
with respondents.

    Dated: November 21, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-26044 Filed 11-24-23; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 83, Number 43 (Monday, March 5, 2018)]
[Notices]
[Pages 9357-9361]
[FR Doc No: 2018-04370]

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SECURITIES AND EXCHANGE COMMISSION

[Investment Company Act Release No. 33037; File No. 812-14773]

TriplePoint Venture Growth BDC Corp., et al.

February 28, 2018.
AGENCY: Securities and Exchange Commission (``Commission'').

ACTION: Notice.

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    Notice of application for an order under sections 17(d) and 57(i)
of the Investment Company Act of 1940 (the ``Act'') and rule 17d-1
under the Act permitting certain joint transactions otherwise
prohibited by sections 17(d) and 57(a)(4) of the Act and under rule
17d-1 under the Act.

Summary of Application: Applicants request an order to permit a
business development company (``BDC'') and certain closed end
management investment companies to co-invest in portfolio companies
with each other and with affiliated investment funds and accounts.

Applicants: TriplePoint Venture Growth BDC Corp. (the ``Company'');
TPVG Variable Funding Company LLC and TPVG Investment LLC
(collectively, the ``Existing Company Subsidiaries''); TPVG Advisers
LLC (the ``BDC Adviser''), on behalf of itself and its successors; \1\
and TriplePoint Capital LLC (``TriplePoint''), TriplePoint Financial
LLC, TPF Funding 1 LLC, TriplePoint Ventures 5 LLC, and TPC Credit
Partners 3 LLC (collectively, with TriplePoint, the ``TPC Companies'').
---------------------------------------------------------------------------

    \1\ The term ``successor,'' as applied to each Adviser, is
limited to an entity that results from a reorganization into another
jurisdiction or change in the type of business organization.

Filing Dates: The application was filed on May 10, 2017, and amended on
---------------------------------------------------------------------------
November 8, 2017.

Hearing or Notification of Hearing: An order granting the requested
relief 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 March 26, 2018, and should be accompanied by proof of
service on applicants, in the form of an affidavit or, for lawyers, a
certificate of service. Pursuant to rule 0-5 under the Act, hearing
requests should state the nature of the writer's interest, any facts
bearing upon the desirability of a hearing on the matter, the reason
for the request, and the issues contested. Persons who wish to be
notified of a hearing may request notification by writing to the
Commission's Secretary.

ADDRESSES: Secretary, U.S. Securities and Exchange Commission, 100 F
St. NE, Washington, DC 20549-1090. Applicants, 2755 Sand Hill Road,
Suite 150, Menlo Park, CA 94025.

FOR FURTHER INFORMATION CONTACT: Christine Y. Greenlees, Senior
Counsel, at<PHONE_NUMBER>, or Robert H. Shapiro, Branch Chief, at
(202) 551-6821 (Chief Counsel's Office, Division of Investment
Management).

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

Applicants' Representations

    1. The Company, a Maryland corporation, is organized as a closed-
end management investment company that has elected to be regulated as a
BDC under section 54(a) of the Act.\2\ The Company's Objectives and
Strategies \3\ are to maximize total return to shareholders primarily
in the form of current income and, to a lesser extent, capital
appreciation, by primarily lending to venture growth stage companies
focused in technology, life sciences and other high growth industries.
The Company has a five-member board of directors (the ``Board''), three
of whom are not ``interested persons'' as defined in section 2(a)(19)
of the Act (the ``Non-Interested Directors'').
---------------------------------------------------------------------------

    \2\ Section 2(a)(48) defines a BDC to be any closed-end
investment company that operates for the purpose of making
investments in securities described in sections 55(a)(1) through
55(a)(3) of the Act and makes available significant managerial
assistance with respect to the issuers of such securities.
    \3\ ``Objectives and Strategies'' means a Regulated Fund's
(defined below) investment objectives and strategies, as described
in the Regulated Fund's registration statement on Form N-2, other
filings the Regulated Fund has made with the Commission under the
Securities Act of 1933 (the ``Securities Act'') or under the
Securities Exchange Act of 1934, and the Regulated Fund's reports to
shareholders.
---------------------------------------------------------------------------

    2. TPVG Variable Funding Company LLC, Delaware limited liability
company, is a wholly-owned subsidiary of the Company established for
utilizing the Company's revolving credit facility.
    3. TPVG Investment LLC, a Delaware limited liability company, is a
wholly-owned subsidiary of the Company established for holding certain
of the Company's investments.
    4. TriplePoint, a Delaware limited liability company, is a global
financing provider. TriplePoint is exempt from registration under the
Act pursuant to section 3(c)(7) of the Act.
    5. Each of TriplePoint Financial LLC, TPF Funding 1 LLC, and
TriplePoint Ventures 5 LLC is a Delaware limited liability company, a
wholly-owned subsidiary of TriplePoint and exempt from registration
under the Act pursuant to section 3(c)(7) of the 1940 Act.
    6. TPC Credit Partners 3 LLC, a Delaware limited liability company,
is a majority-owned subsidiary of TriplePoint and is exempt from
registration under the Act pursuant to section 3(c)(7) of the 1940 Act.
    7. The BDC Adviser, a Delaware limited liability company, is
registered with the Commission as an investment adviser under the
Investment Advisers Act of 1940 (the ``Advisers Act''). The BDC Adviser
is a wholly-owned subsidiary of TriplePoint. The BDC Adviser serves as
investment adviser to the Company.
    8. The TPC Companies, from time to time, may hold various financial
assets in a principal capacity (together, in such capacity, ``Existing
TPC Proprietary Accounts'' and together with any Future TPC Proprietary
Account (as defined below), the ``TPC Proprietary Accounts'').
    9. Applicants seek an order (``Order'') to permit a Regulated Fund
\4\ and one or more other Regulated Funds and/or one or more Affiliated
Funds \5\ to participate

in the same investment opportunities through a proposed co-investment
program (the ``Co-Investment Program'') where such participation would
otherwise be prohibited under either or both of sections 17(d) and
57(a)(4) and rule 17d-1 by (a) co-investing with each other in
securities issued by issuers in private placement transactions in which
an Adviser negotiates terms in addition to price; \6\ and (b) making
additional investments in securities of such issuers, including through
the exercise of warrants, conversion privileges, and other rights to
purchase securities of the issuers (``Follow-On Investments''). ``Co-
Investment Transaction'' means any transaction in which a Regulated
Fund (or its Wholly-Owned Investment Sub, defined below) participated
together with one or more other Regulated Funds and/or one or more
Affiliated Funds in reliance on the requested Order. ``Potential Co-
Investment Transaction'' means any investment opportunity in which a
Regulated Fund (or its Wholly-Owned Investment Sub) could not
participate together with one or more Affiliated Funds and/or one or
more other Regulated Funds without obtaining and relying on the
Order.\7\
---------------------------------------------------------------------------

    \4\ ``Regulated Fund'' means the Company and any Future
Regulated Fund. ``Future Regulated Fund'' means any closed-end
management investment company (a) that is registered under the Act
or has elected to be regulated as a BDC, (b) whose investment
adviser is an Adviser, and (c) that intends to participate in the
Co-Investment Program. The term ``Adviser'' means (a) the BDC
Adviser and (b) any future investment adviser that controls, is
controlled by or is under common control with TriplePoint and is
registered as an investment adviser under the Advisers Act.
    \5\ ``Affiliated Fund'' means the Existing TPC Proprietary
Accounts, any Future TPC Proprietary Accounts and any Future
Affiliated Funds. ``Future TPC Proprietary Account'' means any
direct or indirect, wholly- or majority-owned subsidiary of
TriplePoint that is formed in the future and, from time to time, may
hold various financial assets in a principal capacity. ``Future
Affiliated Fund'' means any entity (a) whose investment adviser is
an Adviser, (b) that would be an investment company but for section
3(c)(1) or 3(c)(7) of the Act, and (c) that intends to participate
in the Co-Investment Program.
    \6\ The term ``private placement transactions'' means
transactions in which the offer and sale of securities by the issuer
are exempt from registration under the Securities Act.
    \7\ All existing entities that currently intend to rely upon the
requested Order have been named as applicants. Any other existing or
future entity that subsequently relies on the Order will comply with
the terms and conditions of the application.
---------------------------------------------------------------------------

    10. Applicants state that any of the Regulated Funds may, from time
to time, form one or more Wholly-Owned Investment Subs.\8\ Such a
subsidiary would be prohibited from investing in a Co-Investment
Transaction with any Affiliated Fund or Regulated Fund because it would
be a company controlled by its parent Regulated Fund for purposes of
section 57(a)(4) and rule 17d-1. Applicants request that each Wholly-
Owned Investment Sub be permitted to participate in Co-Investment
Transactions in lieu of its parent Regulated Fund and that the Wholly-
Owned Investment Sub's participation in any such transaction be
treated, for purposes of the requested Order, as though the parent
Regulated Fund were participating directly. Applicants represent that
this treatment is justified because a Wholly-Owned Investment Sub would
have no purpose other than serving as a holding vehicle for the
Regulated Fund's investments and, therefore, no conflicts of interest
could arise between the Regulated Fund and the Wholly-Owned Investment
Sub. The Regulated Fund's Board would make all relevant determinations
under the conditions with regard to a Wholly-Owned Investment Sub's
participation in a Co-Investment Transaction, and the Regulated Fund's
Board would be informed of, and take into consideration, any proposed
use of a Wholly-Owned Investment Sub in the Regulated Fund's place. If
the Regulated Fund proposes to participate in the same Co-Investment
Transaction with any of its Wholly-Owned Investment Subs, the Board
will also be informed of, and take into consideration, the relative
participation of the Regulated Fund and the Wholly-Owned Investment
Sub.
---------------------------------------------------------------------------

    \8\ The term ``Wholly-Owned Investment Sub'' means an entity (i)
that is wholly-owned by a Regulated Fund (with the Regulated Fund at
all times holding, beneficially and of record, 100% of the voting
and economic interests); (ii) whose sole business purpose is to hold
one or more investments on behalf of the Regulated Fund (and, in the
case of an SBIC Subsidiary (defined below), maintain a license under
the SBA Act (defined below) and issue debentures guaranteed by the
SBA (defined below)); (iii) with respect to which the Regulated
Fund's Board has the sole authority to make all determinations with
respect to the entity's participation under the conditions of the
application; and (iv) that would be an investment company but for
section 3(c)(1) or 3(c)(7) of the Act. Each of the Existing Company
Subsidiaries is a Wholly-Owned Investment Sub. ``SBIC Subsidiary''
means a Wholly-Owned Investment Sub that is licensed by the Small
Business Administration (the ``SBA'') to operate under the Small
Business Investment Act of 1958, as amended, (the ``SBA Act'') as a
small business investment company.
---------------------------------------------------------------------------

    11. When considering Potential Co-Investment Transactions for any
Regulated Fund, the applicable Adviser will consider only the
Objectives and Strategies, investment policies, investment positions,
capital available for investment (``Available Capital''), and other
pertinent factors applicable to that Regulated Fund. Before relying on
the requested Order, the Board of each Regulated Fund, including the
Non-Interested Directors, will have determined that it is in the best
interests of the Regulated Fund to participate in the Co-Investment
Transactions.\9\
---------------------------------------------------------------------------

    \9\ The Regulated Funds, however, will not be obligated to
invest, or co-invest, when investment opportunities are referred to
them.
---------------------------------------------------------------------------

    12. Other than pro rata dispositions and Follow-On Investments as
provided in conditions 7 and 8, and after making the determinations
required in conditions 1 and 2(a), the Adviser will present each
Potential Co-Investment Transaction and the proposed allocation to the
directors of the Board eligible to vote under section 57(o) of the Act
(``Eligible Directors''), and the ``required majority,'' as defined in
section 57(o) of the Act (``Required Majority'') \10\ will approve each
Co-Investment Transaction prior to any investment by the participating
Regulated Fund.
---------------------------------------------------------------------------

    \10\ In the case of a Regulated Fund that is a registered
closed-end fund, the Board members that make up the Required
Majority will be determined as if the Regulated Fund were a BDC
subject to section 57(o).
---------------------------------------------------------------------------

    13. With respect to the pro rata dispositions and Follow-On
Investments provided in conditions 7 and 8, a Regulated Fund may
participate in a pro rata disposition or Follow-On Investment without
obtaining prior approval of the Required Majority if, among other
things: (i) The proposed participation of each Regulated Fund and
Affiliated Fund in such disposition is proportionate to its outstanding
investments in the issuer immediately preceding the disposition or
Follow-On Investment, as the case may be; and (ii) the Board of the
Regulated Fund has approved that Regulated Fund's participation in pro
rata dispositions and Follow-On Investments as being in the best
interests of the Regulated Fund. If the Board does not so approve, any
such disposition or Follow-On Investment will be submitted to the
Regulated Fund's Eligible Directors. The Board of any Regulated Fund
may at any time rescind, suspend or qualify its approval of pro rata
dispositions and Follow-On Investments with the result that all
dispositions and/or Follow-On Investments must be submitted to the
Eligible Directors.
    14. Applicants acknowledge that some of the Affiliated Funds may
not be funds advised by an Adviser because they are TPC Proprietary
Accounts. Applicants do not believe these TPC Proprietary Accounts
should raise issues under the conditions of this Application because
the allocation policies and procedures of the Advisers provide that
investment opportunities are offered to client accounts (including the
Regulated Funds) before they are offered to TPC Proprietary Accounts.
    15. In accordance with each Adviser's allocation policies and
procedures, Potential Co-Investment Transactions will be offered to,
and allocated among, the Affiliated Funds and Regulated Funds based on
each client's particular Objectives and Strategies and in accordance
with the conditions. If the aggregate amount recommended by the
Advisers to be invested by the Affiliated Funds (not including the TPC
Proprietary Accounts) and the Regulated Funds in a Potential Co-
Investment Transaction were equal to or more than the amount of the
investment opportunity, a TPC Proprietary Account would not participate
in the investment

opportunity. If the aggregate amount recommended by the Advisers to be
invested by the Affiliated Funds (not including the TPC Proprietary
Accounts) and the Regulated Funds in a Potential Co-Investment
Transaction were less than the amount of the investment opportunity, a
TPC Proprietary Account would then have the opportunity to participate
in the Potential Co-Investment Transaction in a principal capacity.
    16. Currently, there are no existing Regulated Funds other than the
Company or Affiliated Funds other than TPC Proprietary Accounts. As a
result, the Company and the TPC Proprietary Accounts will be able to
comply with the conditions, including condition 1, because the
conditions require that the TPC Proprietary Accounts will only be
permitted to invest in a Potential Co-Investment Transaction to the
extent that the aggregate demand from the Regulated Funds and the other
Affiliated Funds is less than the total investment opportunity. Once
another Regulated Fund or Affiliated Fund (other than a TPC Proprietary
Account) exists, the Company will no longer have a right of first
refusal and the applicants will continue to comply with the conditions,
including condition 1.
    17. No Non-Interested Director of a Regulated Fund will have a
financial interest in any Co-Investment Transaction, other than through
share ownership in one of the Regulated Funds.
    18. Applicants also represent that if an Adviser or its principals,
or any person controlling, controlled by, or under common control with
an Adviser or its principals, and the Affiliated Funds (collectively,
the ``Holders'') own in the aggregate more than 25% of the outstanding
voting shares of a Regulated Fund (the ``Shares''), then the Holders
will vote such Shares as required under condition 14.

Applicants' Legal Analysis

    1. Section 57(a)(4) of the Act prohibits certain affiliated persons
of a BDC from participating in joint transactions with the BDC or a
company controlled by a BDC in contravention of rules as prescribed by
the Commission. Under section 57(b)(2) of the Act, any person who is
directly or indirectly controlling, controlled by, or under common
control with a BDC is subject to section 57(a)(4). Applicants submit
that each of the Regulated Funds and Affiliated Funds could be deemed
to be a person related to each Regulated Fund in a manner described by
section 57(b) by virtue of being under common control. Section 57(i) of
the Act provides that, until the Commission prescribes rules under
section 57(a)(4), the Commission's rules under section 17(d) of the Act
applicable to registered closed-end investment companies will be deemed
to apply to transactions subject to section 57(a)(4). Because the
Commission has not adopted any rules under section 57(a)(4), rule 17d-1
also applies to joint transactions with Regulated Funds that are BDCs.
Section 17(d) of the Act and rule 17d-1 under the Act are applicable to
Regulated Funds that are registered closed-end investment companies.
    2. Section 17(d) of the Act and rule 17d-1 under the Act prohibit
affiliated persons of a registered investment company from
participating in joint transactions with the company unless the
Commission has granted an order permitting such transactions. In
passing upon applications under rule 17d-1, the Commission considers
whether the company's participation in the joint transaction is
consistent with the provisions, policies, and purposes of the Act and
the extent to which such participation is on a basis different from or
less advantageous than that of other participants.
    3. Applicants state that in the absence of the requested relief,
the Regulated Funds would be, in some circumstances, limited in their
ability to participate in attractive and appropriate investment
opportunities. Applicants believe that the proposed terms and
conditions will ensure that the Co-Investment Transactions are
consistent with the protection of each Regulated Fund's shareholders
and with the purposes intended by the policies and provisions of the
Act. Applicants state that the Regulated Funds' participation in the
Co-Investment Transactions will be consistent with the provisions,
policies, and purposes of the Act and on a basis that is not different
from or less advantageous than that of other participants.

Applicants' Conditions

    Applicants agree that the Order will be subject to the following
conditions:
    1. Each time an Adviser or an Affiliated Fund considers a Potential
Co-Investment Transaction for an Affiliated Fund or another Regulated
Fund that falls within a Regulated Fund's then-current Objectives and
Strategies, the Regulated Fund's Adviser will make an independent
determination of the appropriateness of the investment for such
Regulated Fund in light of the Regulated Fund's then-current
circumstances.
    2. (a) If the Adviser deems a Regulated Fund's participation in any
Potential Co-Investment Transaction to be appropriate for the Regulated
Fund, it will then determine an appropriate level of investment for the
Regulated Fund.
    (b) If the aggregate amount recommended by the applicable Adviser
to be invested by the applicable Regulated Fund in the Potential Co-
Investment Transaction, together with the amount proposed to be
invested by the other participating Regulated Funds and Affiliated
Funds, collectively, in the same transaction, exceeds the amount of the
investment opportunity, the investment opportunity will be allocated
among them pro rata based on each participant's Available Capital, up
to the amount proposed to be invested by each. The applicable Adviser
will provide the Eligible Directors of each participating Regulated
Fund with information concerning each participating party's Available
Capital to assist the Eligible Directors with their review of the
Regulated Fund's investments for compliance with these allocation
procedures.
    (c) After making the determinations required in conditions 1 and
2(a), the applicable Adviser will distribute written information
concerning the Potential Co-Investment Transaction (including the
amount proposed to be invested by each participating Regulated Fund and
Affiliated Fund) to the Eligible Directors of each participating
Regulated Fund for their consideration. A Regulated Fund will co-invest
with one or more other Regulated Funds and/or one or more Affiliated
Funds only if, prior to the Regulated Fund's participation in the
Potential Co-Investment Transaction, a Required Majority concludes
that:
    (i) The terms of the Potential Co-Investment Transaction, including
the consideration to be paid, are reasonable and fair to the Regulated
Fund and its shareholders and do not involve overreaching in respect of
the Regulated Fund or its shareholders on the part of any person
concerned;
    (ii) The Potential Co-Investment Transaction is consistent with:
    (A) The interests of the shareholders of the Regulated Fund; and
    (B) the Regulated Fund's then-current Objectives and Strategies;
    (iii) the investment by any other Regulated Funds or Affiliated
Funds would not disadvantage the Regulated Fund, and participation by
the Regulated Fund would not be on a basis different from or less
advantageous than that of other Regulated Funds or Affiliated Funds;
provided that, if any other Regulated Fund or Affiliated Fund, but not
the Regulated Fund itself, gains the right to nominate a director for

election to a portfolio company's board of directors or the right to
have a board observer or any similar right to participate in the
governance or management of the portfolio company, such event shall not
be interpreted to prohibit the Required Majority from reaching the
conclusions required by this condition (2)(c)(iii), if:
    (A) The Eligible Directors will have the right to ratify the
selection of such director or board observer, if any;
    (B) the applicable Adviser agrees to, and does, provide periodic
reports to the Regulated Fund's Board with respect to the actions of
such director or the information received by such board observer or
obtained through the exercise of any similar right to participate in
the governance or management of the portfolio company; and
    (C) any fees or other compensation that any Affiliated Fund or any
Regulated Fund or any affiliated person of any Affiliated Fund or any
Regulated Fund receives in connection with the right of the Affiliated
Fund or a Regulated Fund to nominate a director or appoint a board
observer or otherwise to participate in the governance or management of
the portfolio company will be shared proportionately among the
participating Affiliated Funds (who each may, in turn, share its
portion with its affiliated persons) and the participating Regulated
Funds in accordance with the amount of each party's investment; and
    (iv) the proposed investment by the Regulated Fund will not benefit
the Advisers, the Affiliated Funds or the other Regulated Funds or any
affiliated person of any of them (other than the parties to the Co-
Investment Transaction), except (A) to the extent permitted by
condition 13, (B) to the extent permitted by section 17(e) or 57(k) of
the Act, as applicable, (C) indirectly, as a result of an interest in
the securities issued by one of the parties to the Co-Investment
Transaction, or (D) in the case of fees or other compensation described
in condition 2(c)(iii)(C).
    3. Each Regulated Fund has the right to decline to participate in
any Potential Co-Investment Transaction or to invest less than the
amount proposed.
    4. The applicable Adviser will present to the Board of each
Regulated Fund, on a quarterly basis, a record of all investments in
Potential Co-Investment Transactions made by any of the other Regulated
Funds or Affiliated Funds during the preceding quarter that fell within
the Regulated Fund's then-current Objectives and Strategies that were
not made available to the Regulated Fund, and an explanation of why the
investment opportunities were not offered to the Regulated Fund. All
information presented to the Board pursuant to this condition will be
kept for the life of the Regulated Fund and at least two years
thereafter, and will be subject to examination by the Commission and
its staff.
    5. Except for Follow-On Investments made in accordance with
condition 8,\11\ a Regulated Fund will not invest in reliance on the
Order in any issuer in which another Regulated Fund, Affiliated Fund,
or any affiliated person of another Regulated Fund or Affiliated Fund
is an existing investor.
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    \11\ This exception applies only to Follow-On Investments by a
Regulated Fund in issuers in which the Regulated Fund already holds
investments.
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    6. A Regulated Fund will not participate in any Potential Co-
Investment Transaction unless the terms, conditions, price, class of
securities to be purchased, settlement date, and registration rights
will be the same for each participating Regulated Fund and Affiliated
Fund. The grant to an Affiliated Fund or another Regulated Fund, but
not the Regulated Fund, of the right to nominate a director for
election to a portfolio company's board of directors, the right to have
an observer on the board of directors or similar rights to participate
in the governance or management of the portfolio company will not be
interpreted so as to violate this condition 6, if conditions
2(c)(iii)(A), (B) and (C) are met.
    7. (a) If any Affiliated Fund or any Regulated Fund elects to sell,
exchange or otherwise dispose of an interest in a security that was
acquired in a Co-Investment Transaction, the applicable Advisers will:
    (i) Notify each Regulated Fund that participated in the Co-
Investment Transaction of the proposed disposition at the earliest
practical time; and
    (ii) formulate a recommendation as to participation by each
Regulated Fund in the disposition.
    (b) Each Regulated Fund will have the right to participate in such
disposition on a proportionate basis, at the same price and on the same
terms and conditions as those applicable to the participating
Affiliated Funds and Regulated Funds.
    (c) A Regulated Fund may participate in such disposition without
obtaining prior approval of the Required Majority if: (i) The proposed
participation of each Regulated Fund and each Affiliated Fund in such
disposition is proportionate to its outstanding investments in the
issuer immediately preceding the disposition; (ii) the Board of the
Regulated Fund has approved as being in the best interests of the
Regulated Fund the ability to participate in such dispositions on a pro
rata basis (as described in greater detail in the application); and
(iii) the Board of the Regulated Fund is provided on a quarterly basis
with a list of all dispositions made in accordance with this condition.
In all other cases, the Adviser will provide its written recommendation
as to the Regulated Fund's participation to the Eligible Directors, and
the Regulated Fund will participate in such disposition solely to the
extent that a Required Majority determines that it is in the Regulated
Fund's best interests.
    (d) Each Affiliated Fund and each Regulated Fund will bear its own
expenses in connection with any such disposition.
    8. (a) If any Affiliated Fund or any Regulated Fund desires to make
a Follow-On Investment in a portfolio company whose securities were
acquired in a Co-Investment Transaction, the applicable Advisers will:
    (i) Notify each Regulated Fund that participated in the Co-
Investment Transaction of the proposed transaction at the earliest
practical time; and
    (ii) formulate a recommendation as to the proposed participation,
including the amount of the proposed Follow-On Investment, by each
Regulated Fund.
    (b) A Regulated Fund may participate in such Follow-On Investment
without obtaining prior approval of the Required Majority if: (i) The
proposed participation of each Regulated Fund and each Affiliated Fund
in such investment is proportionate to its outstanding investments in
the issuer immediately preceding the Follow-On Investment; and (ii) the
Board of the Regulated Fund has approved as being in the best interests
of the Regulated Fund the ability to participate in Follow-On
Investments on a pro rata basis (as described in greater detail in the
application). In all other cases, the Adviser will provide its written
recommendation as to the Regulated Fund's participation to the Eligible
Directors, and the Regulated Fund will participate in such Follow-On
Investment solely to the extent that a Required Majority determines
that it is in the Regulated Fund's best interests.
    (c) If, with respect to any Follow-On Investment:
    (i) The amount of the opportunity is not based on the Regulated
Funds' and the Affiliated Funds' outstanding

investments immediately preceding the Follow-On Investment; and
    (ii) the aggregate amount recommended by the Adviser to be invested
by the Regulated Fund in the Follow-On Investment, together with the
amount proposed to be invested by the other participating Regulated
Funds and the Affiliated Funds in the same transaction, exceeds the
amount of the opportunity;

then the amount invested by each such party will be allocated among
them pro rata based on each participant's Available Capital for
investment in the asset class being allocated, up to the amount
proposed to be invested by each.
    (d) The acquisition of Follow-On Investments as permitted by this
condition will be considered a Co-Investment Transaction for all
purposes and subject to the other conditions set forth in the
application.
    9. The Non-Interested Directors of each Regulated Fund will be
provided quarterly for review all information concerning Potential Co-
Investment Transactions and Co-Investment Transactions, including
investments made by other Regulated Funds or Affiliated Funds that the
Regulated Fund considered but declined to participate in, so that the
Non-Interested Directors may determine whether all investments made
during the preceding quarter, including those investments that the
Regulated Fund considered but declined to participate in, comply with
the conditions of the Order. In addition, the Non-Interested Directors
will consider at least annually the continued appropriateness for the
Regulated Fund of participating in new and existing Co-Investment
Transactions.
    10. Each Regulated Fund will maintain the records required by
section 57(f)(3) of the Act as if each of the Regulated Funds were a
BDC and each of the investments permitted under these conditions were
approved by the Required Majority under section 57(f) of the Act.
    11. No Non-Interested Director of a Regulated Fund will also be a
director, general partner, managing member or principal, or otherwise
an ``affiliated person'' (as defined in the Act) of an Affiliated Fund.
    12. The expenses, if any, associated with acquiring, holding or
disposing of any securities acquired in a Co-Investment Transaction
(including, without limitation, the expenses of the distribution of any
such securities registered for sale under the Securities Act) will, to
the extent not payable by the Advisers under their respective
investment advisory agreements with Affiliated Funds and the Regulated
Funds, be shared by the Regulated Funds and the Affiliated Funds in
proportion to the relative amounts of the securities held or to be
acquired or disposed of, as the case may be.
    13. Any transaction fee \12\ (including break-up or commitment fees
but excluding broker's fees contemplated by section 17(e) or 57(k) of
the Act, as applicable), received in connection with a Co-Investment
Transaction will be distributed to the participating Regulated Funds
and Affiliated Funds on a pro rata basis based on the amounts they
invested or committed, as the case may be, in such Co-Investment
Transaction. If any transaction fee is to be held by an Adviser pending
consummation of the transaction, the fee will be deposited into an
account maintained by such Adviser at a bank or banks having the
qualifications prescribed in section 26(a)(1) of the Act, and the
account will earn a competitive rate of interest that will also be
divided pro rata among the participating Regulated Funds and Affiliated
Funds based on the amounts they invest in such Co-Investment
Transaction. None of the Affiliated Funds, the Advisers, the other
Regulated Funds or any affiliated person of the Regulated Funds or
Affiliated Funds will receive additional compensation or remuneration
of any kind as a result of or in connection with a Co-Investment
Transaction (other than (a) in the case of the Regulated Funds and the
Affiliated Funds, the pro rata transaction fees described above and
fees or other compensation described in condition 2(c)(iii)(C); and (b)
in the case of an Adviser, investment advisory fees paid in accordance
with the agreement between the Adviser and the Regulated Fund or
Affiliated Fund.
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    \12\ Applicants are not requesting and the Commission is not
providing any relief for transaction fees received in connection
with any Co-Investment Transaction.
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    14. If the Holders own in the aggregate more than 25 percent of the
Shares of a Regulated Fund, then the Holders will vote such Shares as
directed by an independent third party when voting on (1) the election
of directors; (2) the removal of one or more directors; or (3) any
other matter under either the Act or applicable state law affecting the
Board's composition, size or manner of election.
    15. The TPC Proprietary Accounts will not be permitted to invest in
a Potential Co-Investment Transaction except to the extent the demand
from the Regulated Funds and the other Affiliated Funds is less than
the total investment opportunity.
    16. Each Adviser will maintain written policies and procedures
reasonably designed to ensure compliance with the foregoing conditions.
These policies and procedures will require, among other things, that
each Adviser will be notified of all Potential Co-Investment
Transactions that fall within the then-current Objectives and
Strategies of any Regulated Fund it advises and will be given
sufficient information to make its independent determination and
recommendations under conditions 1, 2(a), 7 and 8.
    17. Each Regulated Fund's chief compliance officer, as defined in
rule 38a-1(a)(4), will prepare an annual report for its Board that
evaluates (and documents the basis of that evaluation) the Regulated
Fund's compliance with the terms and conditions of the application and
the procedures established to achieve such compliance.

    For the Commission, by the Division of Investment Management,
under delegated authority.
Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2018-04370 Filed 3-2-18; 8:45 am]
 BILLING CODE 8011-01-P