[Federal Register Volume 80, Number 178 (Tuesday, September 15, 2015)]
[Notices]
[Pages 55399-55405]
[FR Doc No: 2015-23093]

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SECURITIES AND EXCHANGE COMMISSION

[Investment Company Act Release No. 31807; 812-13995]

TIAA-CREF Funds, et al.; Notice of Application

September 8, 2015.
AGENCY: Securities and Exchange Commission (``Commission'').

ACTION: Notice of application for an order under sections 6(c) and
17(b) of the Investment Company Act of 1940 (``Act'') for exemptions
from section 17(a) of the Act, and under section 17(d) of the Act and
rule 17d-1 thereunder to permit certain joint transactions.

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Summary of Application: Applicants requests an order that would permit
certain registered management investment companies or series thereof
that are advised by Teachers Advisors, Inc. (``Advisors'') to invest in
a private investment vehicle established by Advisors to invest directly
in real estate.

Applicants: TIAA-CREF Funds (the ``Trust''), Advisors, TIAA-CREF Real
Property Fund LP (``TCLP''), TIAA-CREF Real Property Fund GP LLC
(``TCGP''), and TIAA-CREF Real Property Fund REIT LLC (``TC REIT'').

Filing Dates: The application was filed on January 4, 2012, and amended
on June 25, 2012, December 3, 2012, October 16, 2013, June 26, 2014,
May 8, 2015, and September 4, 2015.

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 October 5, 2015, 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 of the Act, hearing
requests should state the nature of the writer's interest, any facts
bearing upon the desirability of a hearing on the matter, the reason
for the request, and the issues contested. Persons who wish

to be notified of a hearing may request notification by writing to the
Commission's Secretary.

ADDRESSES: Secretary, U.S. Securities and Exchange Commission, 100 F
Street NE., Washington, DC 20549. Applicants: TIAA-CREF, Attn: Rachael
Zufall, 8500 Andrew Carnegie Boulevard, Charlotte, NC, 28262.

FOR FURTHER INFORMATION CONTACT: Mark N. Zaruba, Senior Counsel, at
(202) 551-6878, or David Bartels, Branch Chief, at<PHONE_NUMBER>
(Division of Investment Management, Chief Counsel's Office).

SUPPLEMENTARY INFORMATION: The following is a summary of the
application. The complete application may be obtained via the
Commission's Web site 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 Trust is organized as a Delaware statutory trust and is an
open-end management investment company registered under the Act. The
Trust currently consists of multiple Funds (as defined below).
    2. TCLP is organized as a limited partnership, and applicants state
that it will rely on an exception from the definition of ``investment
company'' such as Section 3(c)(1) or Section 3(c)(7) of the Act (or any
other applicable exclusion). TCGP, the sole general partner of TCLP, is
organized as a limited liability company and will be a direct or
indirect wholly owned subsidiary of Teachers Insurance and Annuity
Association of America (``TIAA''). As general partner of TCLP, TCGP
will be responsible for the operational and administrative maintenance
of TCLP, but it will not exercise any responsibilities for the
management of TCLP's assets.
    3. TC REIT is organized as a limited liability company, and
Applicants anticipate that it will be excluded from the definition of
``investment company'' under Section 3(a)(1) of the Act by reason of
its real estate investments. Applicants state that TC REIT will elect
to be taxed as a real estate investment trust (``REIT'') under the
Internal Revenue Code of 1986, as amended (the ``Code'') and will not
incur separate, entity level tax under the current provisions of the
Code.
    4. Advisors, a Delaware corporation, is an investment adviser that
is registered with the Commission under the Investment Advisers Act of
1940, as amended (the ``Advisers Act''). Advisors is an indirect,
wholly owned subsidiary of TIAA. Advisors will be the investment
adviser to each of the Funds (as defined below), TCLP and TC REIT.\1\
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    \1\ Only Advisors or a successor entity will serve as investment
adviser to TCLP or TC REIT, and any other investment adviser to TCLP
or TC REIT will serve only as investment sub-adviser.
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    5. TIAA and Advisors believe that exposure to direct real estate
investments is an important element of diversified retirement
investing. Advisors seeks to provide shareholders who invest for
retirement and other long-term purposes through the Funds (as defined
below) with exposure to direct real estate. Applicants argue that
direct exposure to real estate offers advantages over investment in
conventional real estate mutual funds that invest primarily in publicly
traded REITs. In addition, Applicants note that, while the Act does not
preclude a registered management investment company from investing
directly in real estate (provided that the fund is not subject to a
fundamental policy precluding such investment and, in the case of an
open-end fund, has sufficient liquidity to comply with applicable
Commission and Commission staff positions), direct investment in real
estate would be impractical due to the typical size of such investments
and for tax reasons. Accordingly, applicants propose to allow each Fund
(solely to the extent consistent with its investment policies,
objectives, strategies and restrictions) to obtain exposure to real
estate through TCLP, which will be dedicated to investing indirectly in
real estate through TC REIT.
    6. For this reason, Applicants request an order under sections 6(c)
and 17(b) of the Act for exemptions from section 17(a) of the Act, and
under section 17(d) of the Act and rule 17d-1 thereunder, to permit:
(i) One or more Funds (as defined below) to purchase, hold and redeem
units of limited partnership interests of TCLP (``Units''); (ii) TCLP
to sell Units to one or more Funds and redeem such Units following
demand of such Funds; (iii) to the extent it could be deemed an element
of a ``joint transaction,'' as defined below, TCLP to purchase, hold
and redeem interests in TC REIT; and (iv) the Funds and Other Accounts
(as defined below) to engage in certain purchase or sale cross
transactions in securities, all as described and subject to the
conditions set forth in the application.\2\
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    \2\ Applicants acknowledge that they are not seeking, and the
Commission is not granting, relief from any disclosure requirements
that are applicable to Applicants.
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    7. Applicants request that the relief extend to each existing or
future registered management investment company or series thereof that
is advised by Advisors or any successor entity or any entity
controlling, controlled by, or under common control with Advisors
(each, a ``Fund'').\3\ Applicants further request that the relief
extend to any future limited partnership (``Future LP''), general
partner thereof (``Future GP''), and underlying real estate investment
vehicle (``Future Real Estate Fund'') in which such Future LP invests
that has elected to be taxed as a REIT pursuant to the Code that
operate in a manner that is identical to TCLP, TCGP and TC REIT except
for the types of real estate investments held by a Future Real Estate
Fund.\4\
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    \3\ Each entity that currently intends to rely on the requested
relief has been named as an applicant. For purposes of the requested
order, ``successor'' is limited to an entity that results from
reorganization into another jurisdiction or a change in the type of
business organization.
    \4\ Any entity that relies in the future on the requested relief
will comply with the terms and conditions of the Application as they
apply to the corresponding current party.
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    8. Applicants state that TC REIT will invest in direct real estate
holdings and, to maintain some liquidity, may invest a portion of its
assets in liquid investments. To finance its investments in real estate
holdings, TC REIT plans to borrow from banks, as well as from insurance
companies, pension/retirement systems, state and federal government
related entities (e.g., Freddie Mac), investment banks, and other
commercial lenders (e.g., GE Capital Corporation (or its successor),
Ally Financial) (lenders other than banks are referred to as ``Non-bank
Commercial Lenders''). Applicants represent that TC REIT plans to incur
loans from Non-bank Commercial Lenders because such lenders have been
longstanding capital resources to the commercial real estate market and
often are able to offer more favorable lending terms to borrowers.\5\
TC REIT will not incur any loans that are callable at the option of the
lender.
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    \5\ Applicants submit that, in light of the presence of a bona
fide business purpose for TCLP and TC REIT and the difficulty a Fund
would have in directly investing in real estate, the structure
proposed by this Application can be distinguished from a structure
intended primarily to evade leverage restrictions applicable to
open-end funds.
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    9. Applicants state that TCLP will invest a substantial portion of
its assets in TC REIT and, if deemed appropriate by Advisors, may, for
purposes of maintaining some liquidity, invest a portion of its assets
in liquid investments. TCLP will incur expenses relating to the
management of any liquid investments held by TCLP, as well as for

the general operation and administration of the entity.\6\
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    \6\ Applicants anticipate that TCLP will be able to efficiently
deploy assets invested by the Funds in light of the ability of TCLP
to invest in liquid investments in addition to interests in TC REIT,
so that any Fund assets invested in TCLP that are not currently
invested in real estate will be effectively deployed pending
completion of real estate investments. The performance of TCLP, the
costs of investing in TCLP, and the related expenses, will be
considered by the Funds' Board during the course of its oversight of
the Funds' investments in TCLP, including its annual determinations
as required by condition 1 below.
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    10. TCLP will conduct a non-public offering of its Units, and will
not be publicly traded. Applicants state that TCLP is currently
expected to be made available solely to the Funds, although it is
possible that it will be made available in the future to: (i)
Unaffiliated registered investment companies, pension plans, other
institutional investors or high-net-worth individuals (``Outside
Investors''); as well as to (ii) pension plans, or other institutional
investors or high-net-worth individuals for which Advisors or an
affiliate of Advisors serves as investment adviser (``Other
Accounts'').\7\
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    \7\ No Applicant, or an affiliated person thereof, will have a
proprietary interest in any Outside Investor or Other Account,
except that an Applicant or an affiliated person thereof may be a
shareholder of an Outside Investor that is a registered investment
company.
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    11. Applicants state that the Funds (as well as any Other Accounts
or Outside Investors) that invest in TCLP will be able to purchase and
redeem Units on a daily basis at the next determined net asset value
(``NAV'') per Unit. In the event that TCLP is unable to accommodate
investment demand from the Funds, Other Accounts and/or Outside
Investors, opportunities for investment will be allocated in accordance
with allocation policies and procedures drafted and maintained by
Advisors.\8\ Applicants represent that, while such allocation policies
and procedures may be subject to revision over time, the allocation
policies and procedures generally will allocate opportunities on a pro
rata basis based on orders received, with normal exceptions for
rounding and de minimis amounts, although applicants state that other
allocation methodologies may be employed as appropriate. Any such
methodology will be applied in a manner that is objective and
verifiable and will be consistent with Advisors' fiduciary obligation
to treat client accounts in a manner that is fair and provides for
equality of opportunity over time. However, TCLP will reserve the right
to give the Funds preferential access to opportunities to invest in
TCLP as compared to Outside Investors and (to the extent permitted
under the allocation policies and procedures) Other Accounts, and the
Funds will always have opportunities to invest in TCLP that are at
least as favorable as the opportunities to invest in TCLP made
available to Other Accounts or Outside Investors. The policies and
procedures will require the documentation of the basis of allocation,
as well as the basis for any exception to the general principles set
forth in the policies and procedures, which exception will be subject
to review by legal or compliance personnel.
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    \8\ Applicants are not seeking any comfort and acknowledge that
the Commission is providing no opinion on whether these allocation
policies and procedures meet the standards applicable under either
the Act or the Advisers Act.
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    12. Applicants anticipate that TCLP will be managed to maintain
sufficient liquidity to satisfy the daily liquidity needs of its
limited partners under ordinary market conditions. However, any
investment in TCLP will be subject to terms permitting TCLP, under
circumstances described in the application, to (a) cease offering new
Units; (b) limit or postpone redemptions in the event that TC REIT has
insufficient liquidity to satisfy redemption requests; or (c) utilize a
``gate'' pursuant to which the amount of redemptions from TCLP by any
limited partner on any business day may be limited to a percentage of
the limited partner's investment in TCLP.\9\ Accordingly, each Fund
that is an open-end investment company will treat its investments in
TCLP and any Future LPs as investments that are not liquid for purposes
of any applicable rules or guidance of the Commission or its staff
regarding the management of liquidity. Similarly, each Fund that is a
closed-end investment company will, at all times, limit its holdings in
TCLP (together with any Future LPs) to no more than 15% of its net
assets.\10\
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    \9\ TCLP expects that the ability to limit or postpone
redemption will help to minimize transaction costs and any dilutive
effects on non-redeeming limited partners. TCLP's ability to limit
or postpone redemption and the circumstances under which TCLP may
waive an established redemption gate, in whole or in part, are
discussed in greater detail in the application.
    \10\ Applicants submit that, although closed-end Funds do not
present the same concerns with respect to liquidity as open-end
Funds, it is nonetheless appropriate to limit the investments of
these Funds in TCLP (and Future LPs) to address concerns that may
arise regarding complex structures and the use of leverage, among
other things.
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    13. Redemption requests will be considered on a first in basis
based upon the business day of receipt, unless a limited partner (other
than a registered investment company or Other Account) has agreed to a
lower priority of redemption. Except as a limited partner (other than a
registered investment company or Other Account) has otherwise agreed,
redemption requests of all investors will be treated equally, and TCLP
will allocate redemption proceeds on a pro rata basis in the event that
there are insufficient liquid assets to satisfy fully all redemption
requests. The rules on redemption and TCLP's policy regarding the
allocation of redemption proceeds, and any changes to either of these,
will be disclosed to all prospective investors in TCLP. TCLP will have
a written policy regarding the allocation of redemption proceeds that
will be applied in a manner that is objective and verifiable and will
be consistent with Advisors' fiduciary obligation to treat client
accounts in a manner that is fair.
    14. Each Fund and Other Account limited partner of TCLP will have
identical rights, duties and obligations under the limited partnership
agreement as each other Fund and Other Account limited partner. If
Outside Investors are permitted to invest in TCLP, the Funds and Other
Accounts will be entitled to purchase, hold and redeem Units on terms
that are at least as favorable, including (without limitation) the
expenses associated with an investment in TCLP, as the terms on which
any Outside Investor purchases, holds or redeems Units. Limited
partners other than the Funds and Other Accounts will have
substantially similar rights, duties and obligations as the Funds and
Other Accounts, but Applicants currently contemplate that they may
distinguish among Outside Investors with respect to rights, duties and
obligations pursuant to the terms of the limited partnership agreement,
or otherwise, with respect to the following issues (without
limitation): (a) Utilization of redemption gates; (b) limitation of
rights of redemption; or (c) the level of expenses charged to limited
partners other than the Funds and Other Accounts in connection with an
investment in TCLP, which may be higher than the level of expenses
borne by the Funds and Other Accounts.
    15. TCLP will be able to purchase and redeem limited liability
company interests in TC REIT on a daily basis at the next determined
NAV. Applicants represent that TCLP will be the sole investor in TC
REIT, other than the ninety-nine or more additional investors necessary
or appropriate to allow TC REIT to qualify as a REIT under section
856(a)(5) of the Code (the ``Tax Holders''). The Tax Holders' interests
in TC REIT will be preferred to TCLP's interests in TC REIT. However,
(a) the Tax Holders will have only limited

voting rights, (b) the Tax Holders' aggregate interests in TC REIT will
be de minimis in relation to that of TCLP,\11\ and (c) TC REIT will not
issue additional interests to the Tax Holders after the initial
organization of TC REIT (clause (a), (b), and (c), collectively, the
``Tax Holder Limitations'').\12\ Accordingly, it is anticipated that
TCLP will own substantially all of the total outstanding securities of
TC REIT at all times during the operation of TC REIT.
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    \11\ Applicants anticipate that the Tax Holders will invest, in
aggregate, approximately $125,000 and will represent much less than
1% of the expected aggregate net assets of TC REIT.
    \12\ The Tax Holders' interests in TC REIT and the Tax Holder
Limitations are discussed in greater detail in the application.
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    16. Applicants represent that TC REIT will not participate in any
joint enterprise or other joint arrangement, within the meaning of rule
17d-1 under the Act, with the Future Real Estate Funds or other TIAA
related accounts, and the Applicants are not asking for an order
pursuant to rule 17d-1 with respect to any such transaction. Further,
Applicants state that TIAA has adopted policies and procedures
applicable to any purchasing conflicts between TC REIT and any other
TIAA related accounts, which are designed to allocate opportunities
consistent with Advisors' fiduciary obligations to its clients and will
be applied in a manner that is objective and verifiable.

Applicants' Legal Analysis

Section 17(a)--Purchase and Sale of Units

    1. Section 17(a) of the Act generally prohibits an ``affiliated
person'' as defined by section 2(a)(3) of the Act, or an affiliated
person of an affiliated person, of a registered investment company,
acting as principal, from purchasing securities or other property from
the registered investment company or selling securities or other
property to the registered investment company. Section 2(a)(3) of the
Act defines an ``affiliated person'' of another person to include,
among others, (a) any person directly or indirectly owning,
controlling, or holding with power to vote, 5% or more of the
outstanding voting securities of the other person; (b) any person 5% or
more of whose outstanding voting securities are directly or indirectly
owned, controlled, or held with the power to vote by the other person;
and (c) any person directly or indirectly controlling, controlled by,
or under common control with the other person. Section 2(a)(9) defines
``control'' to mean ``the power to exercise a controlling influence
over the management or policies of a company, unless such power is
solely the result of an official position with such company.''
    2. Section 17(b) of the Act authorizes the Commission to grant an
order permitting a transaction otherwise prohibited by section 17(a) if
the terms of the proposed transaction, including the consideration to
be paid or received, are fair and reasonable and do not involve
overreaching on the part of any person concerned, and the proposed
transaction is consistent with the policies of each registered
investment company involved and with the general purposes of the Act.
Section 6(c) of the Act permits the Commission to exempt any person or
transactions from any provisions of the Act 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.
    3. Applicants state that the sale by TCLP of its Units to a Fund or
the repurchase by TCLP of its Units from a Fund may be deemed to be
prohibited by section 17(a) of the Act, as TCLP and each Fund may be
deemed to be affiliated persons, or affiliated persons of affiliated
persons, of each other under multiple theories. For example, the Fund
may be deemed to be an affiliated person of TCLP in the event that it
owns 5% or more of the Units in TCLP. In addition, TCLP could be deemed
to be an affiliated person of an affiliated person of the Fund, if it
is deemed to be under the control of or under common control with
Advisors.
    4. Applicants believe that the proposed transactions among the
Funds and TCLP satisfy the requirements for relief from section 17(a)
of the Act under both sections 17(b) and 6(c) of the Act.
    5. Applicants submit that the proposed transactions are reasonable
and fair and would not involve overreaching on the part of any person
concerned. Before investment by a Fund in TCLP, the Fund's board of
trustees (the ``Board''), including a majority of the Independent
Trustees, would have made the determinations required under condition 1
below.\13\ The Board, including the Independent Trustees, will review
these determinations on at least an annual basis. Applicants represent
that, currently, the Board is made up of ten trustees, all of whom are
Independent Trustees. Further, Applicants notes that Advisors' ability
to allocate a Fund's assets to investments in TCLP would be limited to
address any potential for overreaching because (a) the allocation would
be determined either by the Fund's glide path or would be within a
range of permissible allocations approved in advance by the Board and
(b) the Fund's investment would be limited under condition 3 below.
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    \13\ The ``Independent Trustees'' are the trustees who are not
interested persons of the Trust within the meaning of section
2(a)(19) of the Act.
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    6. In addition, Applicants state that each Fund would purchase and
sell Units on the same terms as each other Fund and any Other Account,
and on terms that are at least as favorable as the terms on which
Outside Investors would purchase and sell Units. TCLP also would sell
its shares to or purchase its shares from a Fund at the next-calculated
NAV per Unit. This value, which would be provided to the Funds on a
daily basis, would be determined based on the valuations of the assets
of TC REIT, which would be determined by using valuation methodologies
that are consistent with section 2(a)(41) of the Act except that the
TCLP Committee will, in reliance on independent appraisals obtained at
least quarterly, make determinations that would otherwise be made by a
board of directors.\14\
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    \14\ Applicants note that, in accordance with condition 9, TCLP
will consolidate TC REIT for reporting purposes and the consolidated
financial statements of TCLP will be prepared in accordance with
Regulation S-X, will be audited by an independent auditor, and, if
practicable, will be prepared as of the same date and for the same
periods as the investing Funds. Applicants state that the Public
Company Accounting Oversight Board auditing standards applicable to
the audit of TCLP would be the same standards as those applicable to
a registered investment company. Further, Applicants state that the
U.S. Generally Accepted Accounting Principles and Regulation S-X
would apply to the financial statements of both TCLP and a
registered investment company. Thus, Applicants assert that critical
accounting policies governing security valuation, accounting for
investment transactions, recognition of investment income and of
expenses, and accrual of expenses, which are often the critical
policies applicable to investment companies, would apply in
substantially the same manner for the financial statements of TCLP.
Valuation of the assets of TCLP and TC REIT for which market
quotations are not readily available will be overseen by a committee
consisting of the employees and agents of TCLP, TIAA and/or its
subsidiaries (the ``TCLP Committee'').
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    7. Applicants further submit that the proposed transactions would
be consistent with the policies of each Fund. Applicants represent that
the investment by a Fund in TCLP would be effected in accordance with
the investment policies, objective, strategies and restrictions
contained in the registration statement of the Fund.
    8. Finally, Applicants submit that, for these reasons, as well as
the benefits shareholders in the Funds would

experience by reason of the Funds' investments in TCLP, the proposed
transactions are 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.

Section 17(d)

    9. Section 17(d) of the Act and rule 17d-1 under the Act generally
prohibit joint transactions involving registered investment companies
and their affiliates unless the Commission has approved the
transaction. In considering whether to approve a joint transaction
under rule 17d-1, the Commission considers whether the proposed
transaction is consistent with the provisions, policies, and purposes
of the Act, and the extent to which the participation of the investment
companies is on a basis different from or less advantageous than that
of the other participants.
    10. Applicants state that the sale of Units to a Fund, the Fund's
holding of Units, the redemption of Units held by the Fund, an Other
Account's purchase, holding and redemption of Units alongside a Fund,
TCLP's purchase, holding and redemptions of interest in the TC REIT,
and Advisors' management of the Funds, Other Accounts, TCLP and TC REIT
at the same time that the Funds are investing in TCLP (directly) and TC
REIT (indirectly) could be deemed to constitute a joint enterprise or
joint arrangement among the Funds, Other Accounts, TCLP, TCGP, TC REIT,
and Advisors because the Funds may be presumed to be affiliated
persons, or affiliated persons of affiliated persons, of Advisors,
Other Accounts, TCLP or TC REIT.
    11. For the reasons discussed above, Applicants submit that the
proposed transactions are consistent with the provisions, policies and
purposes of the Act. Applicants further believe that, based on the
terms of the proposed transactions and the conditions set forth below,
the participation by the Funds in the proposed transactions would be on
a basis no different from that of other Funds or Other Accounts or less
advantageous than that of other Funds, Outside Investors or Other
Accounts. A Fund will hold Units of TCLP only if it will at all times
have identical rights, duties and obligations under the limited
partnership agreement as each other Fund limited partner and Other
Account limited partner. If Outside Investors or Other Accounts are
permitted to invest in TCLP, the Funds will be entitled to purchase,
hold and redeem Units on terms that are at least as favorable,
including (without limitation) the expenses associated with an
investment in TCLP, as the terms on which any Outside Investor
purchases, holds or redeem Units and on terms that are the same as the
terms on which any Other Account purchases, holds or redeems Units.
TCLP and the Tax Holders will be the only investors in TC REIT, and the
Tax Holders' interests will be subject to the Tax Holder Limitations.
All transactions in Units would be priced in the same manner and would
be redeemable under the terms discussed herein and disclosed to
investors. In addition, any investment by a Fund in TCLP would be
subject to oversight by the Fund's Board.

Section 17(a)--Cross Transactions

    12. Applicants also propose that the Funds and Other Accounts be
permitted to engage in certain purchase and sale cross transactions in
securities (``Cross Transactions''). Applicants expect that these
transactions will be between a Fund seeking to implement a portfolio
strategy and an Other Account seeking to raise or invest cash, or vice
versa. Applicants represent that the Funds currently are able rely on
rule 17a-7 to engage in such Cross Transactions. However, if a Fund and
an Other Account were deemed to be affiliated persons of an affiliated
person of each other by virtue of their ownership or control
affiliations with TCLP, the Funds may not be entitled to rely on rule
17a-7 because they would no longer be affiliated solely for the reasons
permitted by the rule. Applicants represent that Funds and Other
Accounts will not engage in Cross Transactions involving Units, and to
the extent any Future LPs are created, TCLP and the Future LPs (and
their respective subsidiaries) will not engage in cross-trades with
each other.
    13. Applicants represent that, when engaging in Cross Transactions,
the Funds and Other Accounts will comply with the requirements set
forth in rule 17a-(7)(a) through (g), as interpreted by the Commission
staff. Applicants assert that the potential affiliations created by the
TCLP structure do not affect the other protections provided by the
rule, including the integrity of the pricing mechanism employed and
oversight by each Fund's Board. Applicants also note that no brokerage
commission, fee or other remuneration will be paid in connection with
the transactions. Applicants, therefore, believe that Cross
Transactions will be reasonable and fair, will not involve
overreaching, and will be consistent with the purposes of the Act and
the investment policy of each Fund.

Applicants' Conditions

    Applicants agree that any order granting the requested relief shall
be subject to the following conditions:
    1. Advisors will not implement an initial decision to invest the
assets of a Fund in TCLP unless prior to the Fund's initial investment
in TCLP, the Board, including a majority of the Independent Trustees,
has determined that: (a) Investment in TCLP (and indirectly in TC REIT)
is an appropriate means to implement an investment decision made by
Advisors for the Fund to seek real estate exposure; (b) investment in
TCLP (and indirectly in TC REIT) is in the best interests of the Fund
and its shareholders, taking into account, among other things, the
management and administration fees of TCLP and TC REIT; (c) the
management and administration fees to be charged by TCLP and TC REIT
are for services in addition to, rather than duplicative of, services
rendered to the Fund directly; and (d) the management and
administration fees to be charged by TCLP and TC REIT are fair and
reasonable in light of the usual and customary fees charged by others
for services of the same nature and quality. The Board, including the
Independent Trustees, will review these determinations on at least an
annual basis. The basis for each of the Board's determinations required
by this condition will be recorded in its minutes. If the Board does
not make the determinations in clauses (c) and (d) in a review
subsequent to the initial investment, Advisors will reimburse the Fund
the amount of any management and administrative fee borne by the Fund
as a direct investor in TCLP and an indirect investor in TC REIT
charged since the most recent date on which the Board did make these
determinations.
    2. Prior to any initial or additional investments in Units,
Advisors will determine that each Fund's investment in TCLP will be
consistent with the Fund's investment policies, objective, strategies
and restrictions, and purchases of Units will be determined either by
the Fund's glide path or be limited such that total holdings remain
within a range of permissible allocations approved in advance by the
Board. For purposes of determining consistency with a Fund's investment
policies, objective, strategies and restrictions, a Fund will look
through its investment in TCLP (and indirectly in TC REIT) and apply
its investment policies, objective, strategies and restrictions (except
for any restriction relevant to the direct ownership of real estate
assets) in such a manner that the Fund will not do

indirectly through TCLP and TC REIT that which it cannot do directly.
For purposes of applying its investment policies, objective, strategies
and restrictions, a Fund will be considered as owning its pro rata
portion of the portfolio holdings of TCLP and TC REIT.
    3. Each Fund that is an open-end investment company will treat its
entire investments in TCLP and any Future LPs as investments that are
not liquid for purposes of any applicable rules or guidance of the
Commission or its staff regarding the management of liquidity. For
example, under current guidelines, each such Fund must limit its
aggregate holdings of illiquid assets, which for purposes of the
requested relief include any investments in TCLP and any Future LPs, to
15% of its net assets. In addition, each Fund, including any open- or
closed-end investment company, will, at all times, limit its holdings
in TCLP (together with any Future LPs) to no more than 15% of its net
assets.\15\
---------------------------------------------------------------------------

    \15\ Although closed-end Funds do not present the same concerns
with respect to liquidity as open-end Funds, Applicants believe that
it is nonetheless appropriate to limit the investments of these
Funds in TCLP (and Future LPs) to address concerns that may arise
regarding complex structures and the use of leverage, among other
things.
---------------------------------------------------------------------------

    4. At all times that any Fund or other registered investment
company holds an interest in TCLP, each of TCLP and TC REIT: (a) Will
determine its respective net asset value per Unit or membership
interest, as applicable, each Business Day; and (b) will maintain and
comply with policies and procedures for valuing its assets that are
consistent with section 2(a)(41) of the Act except that the TCLP
Committee will, in reliance on independent appraisals obtained at least
quarterly, make determinations that would otherwise be made by a board
of directors (as if TCLP and TC REIT were subject to section 2(a)(41))
and with applicable U.S. generally accepted accounting principles
(``U.S. GAAP'') (or successor accounting standards). For these
purposes, ``Business Day'' means each day on which the Funds or other
registered investment company determine net asset value per share, as
disclosed in the Funds' or other registered investment company's
registration statement.
    5. A Fund will hold Units of TCLP only if it will at all times have
identical rights, duties and obligations under the limited partnership
agreement as each other Fund limited partner and Other Account limited
partner. If Other Accounts or Outside Investors are permitted to invest
in TCLP, the Funds will be entitled to purchase, hold and redeem Units
on terms that are at least as favorable, including (without limitation)
the expenses associated with an investment in TCLP, as the terms on
which any Outside Investor purchases, holds or redeems Units and on
terms that are the same as the terms on which any Other Account
purchases, holds or redeems Units. Other than the Tax Holders'
interests, which will be subject to the Tax Holder Limitations, TCLP
will own at all times 100% of the voting and economic interests in TC
REIT.
    6. TC REIT and TCLP will be managed by an investment adviser that
is registered as an investment adviser with the Commission. Any
investment sub-adviser to TC REIT or TCLP will be registered as an
investment adviser with the Commission or, if not registered, will
consent to examination by the Commission staff with respect to the
services it would provide to TC REIT or TCLP as if it were registered
as an investment adviser.
    7. The Funds' proposed investments in TCLP, and TCLP's investment
in TC REIT, will not be subject to any sales load, redemption fee,
distribution fee analogous to a 12b-1 fee, or service fee analogous to
a FINRA Rule 2830 service fee imposed by TCLP or TC REIT.
    8. Advisors shall cause TCGP, TCLP and TC REIT to maintain books
and records as is consistent with Internal Revenue Service guidance and
U.S. GAAP, shall cause the books and records of TCGP, TCLP and TC REIT
to be made available for inspection by the Commission staff as would be
required by the Act if each of TCGP, TCLP and TC REIT was a registered
investment company, and, if requested, shall furnish copies of the
books and records to the Commission staff.
    9. TCLP will prepare consolidated annual and semi-annual financial
reports and, for each quarter for which a semi-annual or annual report
is not required to be prepared, a consolidated schedule of investments
for TCLP. The financial statements of TCLP will be prepared in
accordance with Regulation S-X and U.S. GAAP, will be audited by an
independent auditor (for annual financial statements), and, if
practicable, will be prepared as of the same date and for the same
periods as the investing Funds. TCLP will consolidate TC REIT for
financial reporting purposes. Any consolidated schedule of investments
of TCLP will disclose each position that TCLP and TC REIT hold. The
Trust, on behalf of each Fund that has invested 5% or more of its net
assets in TCLP \16\ as of the end of a reporting period, will attach,
as an exhibit to each of the Trust's shareholder reports with respect
to such a Fund filed on Form N-CSR and each of the Trust's quarterly
reports with respect to such a Fund filed on Form N-Q, TCLP's audited
or unaudited financial statements (which will consist of financial
statements, footnotes, thereto and a schedule of investments) or
schedule of investments for the period most recently ended. TCLP will
deliver such annual and semi-annual financial statements and schedules
of investments to the Trust in time to allow the Trust to make such
filings. The relevant Fund's shareholder reports and quarterly reports
will cross-reference the TCLP financial statements (for annual and
semi-annual reports) or schedule of investments (for other quarters)
filed as an exhibit to the form. If a Fund is required to attach and
cross-reference the financial statements of TCLP solely for purpose of
complying with this condition 9, (a) the Fund may disclaim that (i) the
TCLP financial statements or schedule of investments constitute part of
the Fund's financial statements, shareholder report or quarterly
report, and (ii) the TCLP financial statements or schedule of
investments are incorporated therein by reference, and (b) the
certifications for each principal executive and principal financial
officer required by rule 30a-2(a) under the Act that accompany Form N-
CSR or Form N-Q filings with respect to such a Fund may make clear that
the TCLP financial statements or schedule of investments that accompany
the Form N-CSR or Form N-Q filings do not constitute part of the report
to which the certificate relates.\17\
---------------------------------------------------------------------------

    \16\ Investments in any Future LPs will be aggregated with
investments in TCLP to determine whether a Fund has invested 5% or
more of its net assets. If the aggregate investments are 5% or more,
then the disclosure requirements under this condition will apply
(for that Fund) with respect to information about TCLP and each
Future LP in which that Fund is invested.
    \17\ As noted above, the requested order does not include relief
from any existing disclosure requirements. Accordingly, the
disclaimer and clarification contemplated in clauses (a) and (b)
could not be included if the Fund is required to disclose
information regarding the financial statements of TCLP for any
purpose other than complying with this condition 9.
---------------------------------------------------------------------------

    10. Neither TCLP nor TC REIT will acquire securities of any other
investment company or company relying on section 3(c)(1) or 3(c)(7) of
the Act in excess of the limits contained in section 12(d)(1)(A) of the
Act, except to the extent that TCLP or TC REIT: (a) Receives securities
of another investment company as a dividend or as a result of a plan of
reorganization of a company (other than a plan devised for the purpose
of evading section 12(d)(1) of the Act); or (b) acquires (or is deemed

to have acquired) securities of another investment company pursuant to
exemptive relief from the Commission permitting TCLP or TC REIT to (i)
acquire securities of one or more investment companies for short-term
cash management purposes, or (ii) engage in interfund borrowing and
lending transactions.
    11. A Fund will treat any leverage that TCLP or TC REIT incurs as
though such leverage were incurred by the Fund for purposes of
determining compliance with applicable restrictions under the Act
relevant to the Fund's use of leverage. Under no circumstances will a
Fund guarantee, or otherwise be responsible for the satisfaction of,
any loan or obligation incurred by TCLP or TC REIT.
    12. The TCLP and TC REIT will comply with the following sections of
the Act as if the TCLP and TC REIT each were an open-end management
investment company registered under the Act, except as noted: Section
9; section 12 (except that, to the extent necessary to implement the
arrangements described herein, (i) the Funds may invest in Units issued
by TCLP in accordance with condition 3, (ii) TCLP may issue Units to
the investing Funds subject to the limits in condition 3, and (iii)
TCLP may invest in TC REIT beyond the limits of sections 12(d)(1)(A)
and (B)); section 13 (provided that section 13(a)(4) will apply as
though it read only ``change the nature of its business''; the
interests issued by TCLP and TC REIT will be regarded as voting
securities under section 2(a)(42) of the Act for purposes of applying
this condition; and the offering memoranda utilized by TCLP and TC REIT
to offer and sell their interests will be regarded as registration
statements for purposes of applying this condition); section 17(a)
(except insofar as relief is provided by the order requested herein);
section 17(d) (except insofar as relief is provided by the order
requested herein); section 17(e); section 17(f); section 17(h); section
18 (although (a) the interests issued by TCLP and TC REIT will be
regarded as voting securities under section 2(a)(42) of the Act for
purposes of applying this condition, (b) TC REIT will be permitted to
incur loans from Non-bank Commercial Lenders, subject to the asset
coverage limit, and (c) TC REIT will not be required to restore 300%
asset coverage within three days, as required under section 18(f), if
such asset coverage falls below 300% solely as a result of a decline in
the value of TC REIT's real estate holdings); section 21; section 36;
and sections 37-53. In addition, the TCLP and TC REIT will comply with
the rules under section 17(f) \18\ and section 17(g) of the Act, as
well as rule 22c-1 under the Act as if each of the TCLP and TC REIT
were an open-end management investment company registered under the
Act.
---------------------------------------------------------------------------

    \18\ Applicants note that they will operate TCLP and TC REIT
such that rules under section 17(f) will not be applicable to either
entity.
---------------------------------------------------------------------------

    Advisors will cause TCGP, TCLP and TC REIT to, and TCGP, TCLP and
TC REIT will, adopt policies and procedures designed to ensure that
each of TCLP and TC REIT complies with the aforementioned sections of
the Act and rules under the Act. Advisors will cause TCGP, TCLP and TC
REIT to, and TCGP, TCLP and TC REIT will, periodically review and
periodically update as appropriate such policies and procedures,
maintain books and records describing such policies and procedures, and
maintain the records required by rules 31a-1(b)(1), 31a-1(b)(2)(ii) and
31a-1(b)(9) under the Act. All books and records required to be made
pursuant to this condition will be maintained and preserved for a
period of not less than six years from the end of the fiscal year in
which any transaction occurs, the first two years in an easily
accessible place, and will be subject to examination by the Commission
and its staff.
    For purposes of implementing condition 12, any action that the
above-referenced statutory and regulatory provisions require to be
taken or made by the directors, officers and/or employees of a
registered investment company will be performed by TCGP with respect to
TCLP, and by Advisors (or its successor),\19\ as managing member with
respect to TC REIT. As noted in this Application, the TCLP Committee
will oversee the valuation of the assets of TCLP and TC REIT for which
market quotations are not readily available, which also will be
relevant to the implementation of condition 12.
---------------------------------------------------------------------------

    \19\ See supra, note 2.
---------------------------------------------------------------------------

    13. To engage in Cross Transactions, the Funds will comply with
rule 17a-7 under the Act in all respects other than the requirement
that the parties to the transaction be affiliated persons (or
affiliated persons of affiliated persons) of each other solely by
reason of having a common investment adviser or investment advisers
which are affiliated persons of each other, common officers, and/or
common directors, solely because a Fund and Other Account might become
affiliated persons within the meaning of section 2(a)(3)(A), (B) or (C)
of the Act because of their investments in TCLP.

    For the Commission, by the Division of Investment Management,
under delegated authority.
Robert W. Errett,
Deputy Secretary.
[FR Doc. 2015-23093 Filed 9-14-15; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 77, Number 210 (Tuesday, October 30, 2012)]
[Notices]
[Page 65754]
[FR Doc No: 2012-26638]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-68096, File No. SR-C2-2012-030]

Self-Regulatory Organizations; C2 Options Exchange, Incorporated;
Order Approving Proposed Rule Change Relating to the Complex Order
Auction Process

October 24, 2012.

I. Introduction

    On August 30, 2012, the C2 Options Exchange, Incorporated
(``Exchange'' or ``C2'') 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 modify C2 Rule 6.13(c),
``Process for Complex Order RFR Auction,'' to: (i) Include the side of
the market in the request for response (``RFR'') message sent to
Participants at the start of a Complex Order Auction (``COA''); and
(ii) require responses to an RFR message (``RFR Responses'') to be on
the opposite side of the market from the order being auctioned in a
COA. The proposed rule change was published for comment in the Federal
Register on September 17, 2012.\3\ The Commission received no comment
letters regarding the proposal. This order approves the proposed rule
change.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 67828 (September 11,
2012), 77 FR 57173 (``Notice'').
---------------------------------------------------------------------------

II. Description of the Proposal

    COA is an automated RFR auction process for COA-eligible orders.\4\
On receipt of a COA-eligible order and a request from the Participant
representing the order that the order be subjected to a COA, C2 sends
an RFR message to all Participants that have elected to receive RFR
messages.\5\ The RFR message identifies the component series, the size
of the COA-eligible order, and any contingencies, if applicable, but
not the side of the market (i.e. whether the order is to buy or to
sell).\6\ Responders to the COA, who do not know the side of the market
of the order being auctioned, may submit RFR Responses on both sides of
the market.\7\ Because RFR Responses on the same side of the market as
the COA-eligible order cannot trade with the order and thus are
unnecessary, C2's trading system automatically rejects these RFR
Responses.\8\
---------------------------------------------------------------------------

    \4\ A ``COA-eligible order'' is a complex order that, as
determined by the Exchange on a class-by-class basis, is eligible
for a COA considering the order's marketability (defined as a number
of ticks away from the current market), size, complex order type,
and complex order origin (i.e. non-broker-dealer public customer,
broker-dealers that are not Market-Makers or specialist on an
options exchange, and/or Market-makers or specialists on an options
exchange). See C2 Rule 6.13(c)(1)(B).
    \5\ See C2 Rule 6.13(c)(2).
    \6\ See id.
    \7\ See Notice, supra note 3, at 57174.
    \8\ See id.
---------------------------------------------------------------------------

    The Exchange proposes to amend C2 Rule 6.13(c) to: (i) Include the
side of the market in the RFR message sent to Participants at the start
of a COA; and (ii) require RFR Responses to be on the opposite side of
the market from the order being auctioned in a COA. C2 believes that
these proposed changes will make the COA process more efficient by
eliminating the entry of unnecessary RFR Responses that cannot trade
with the COA order.\9\ C2 also believes that this increased efficiency
could lead to more meaningful and competitively priced RFR Responses,
which could result in better prices for customers.\10\
---------------------------------------------------------------------------

    \9\ See id.
    \10\ See id.
---------------------------------------------------------------------------

III. Discussion

    After careful consideration of the proposed rule change, the
Commission finds that the proposal is consistent with the requirements
of the Act and the rules and regulations thereunder applicable to a
national securities exchange.\11\ The Commission believes that the
proposed rule change is consistent with Section 6(b) of the Act, in
general, and Section 6(b)(5) of the Act,\12\ in particular, in that it
is designed 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.
More specifically, the Commission believes that the proposal could
improve the efficiency of the COA process by eliminating unnecessary
RFR Responses, which otherwise would been rejected automatically by
C2's trading system.
---------------------------------------------------------------------------

    \11\ In approving this proposed rule change, the Commission has
considered the proposed rule's impact on efficiency, competition,
and capital formation. See 15 U.S.C. 78c(f).
    \12\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

IV. Conclusion

    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\13\ that the proposed rule change (SR-C2-2012-030) is approved.
---------------------------------------------------------------------------

    \13\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\14\
---------------------------------------------------------------------------

    \14\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2012-26638 Filed 10-29-12; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 80, Number 129 (Tuesday, July 7, 2015)]
[Notices]
[Pages 38694-38695]
[FR Doc No: 2015-16563]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-D-2244

Qualification of Biomarker--Plasma Fibrinogen in Studies
Examining Exacerbations and/or All-Cause Mortality for Patients With
Chronic Obstructive Pulmonary Disease; Draft Guidance for Industry;
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled
``Qualification of Biomarker--Plasma Fibrinogen in Studies Examining
Exacerbations and/or All-Cause Mortality in Patients With Chronic
Obstructive Pulmonary Disease.'' This draft guidance provides a
qualified context of use (COU) for plasma fibrinogen in interventional
clinical trials of chronic obstructive pulmonary disease (COPD)
subjects at high risk for exacerbations and/or all-cause mortality.
This draft guidance also describes the experimental conditions

and constraints for which this biomarker is qualified through the
Center for Drug Evaluation and Research (CDER) Biomarker Qualification
Program. This biomarker can be used by drug developers for the
qualified COU in submissions of investigational new drug applications
(INDs), new drug applications (NDAs), and biologics license
applications (BLAs) without the relevant CDER review group
reconsidering and reconfirming the suitability of the biomarker.
    In the Federal Register of January 7, 2014, FDA announced the
availability of a final guidance for industry entitled ``Qualification
Process for Drug Development Tools'' that described the process that
would be used to qualify drug development tools (DDTs) and to make new
DDT qualification recommendations available on FDA's Web site. The
qualification recommendations in this draft guidance were developed
using the process described in that guidance.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by September 8, 2015.

ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information, Center for Drug
Evaluation and Research, Food and Drug Administration, 10001 New
Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD
20993-0002. Send one self-addressed adhesive label to assist that
office in processing your requests. See the SUPPLEMENTARY INFORMATION
section for electronic access to the draft guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Marianne Noone, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 21, Rm. 4528, Silver Spring, MD 20993-0002, 301-
796-2600.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Qualification of Biomarker--Plasma Fibrinogen in Studies
Examining Exacerbations and/or All-Cause Mortality for Chronic
Obstructive Pulmonary Disease.'' This draft guidance provides
qualification recommendations for the use of plasma fibrinogen,
measured at baseline, as a prognostic biomarker to enrich clinical
trial populations of COPD subjects at high risk for exacerbations and/
or all-cause mortality for inclusion in interventional clinical trials.
This biomarker should be considered with other subject demographic and
clinical characteristics, including a prior history of COPD
exacerbations, as an enrichment factor in these trials.
    Specifically, this draft guidance provides the COU for which this
biomarker is qualified through the CDER Biomarker Qualification
Program. Qualification of this biomarker for this specific COU
represents the conclusion that analytically valid measurements of the
biomarker can be relied on to have a specific use and interpretable
meaning. This biomarker can be used by drug developers for the
qualified COU in submission of IND applications, NDAs, and BLAs without
the relevant CDER review group reconsidering and reconfirming the
suitability of the biomarker. ``Qualification'' means that the use of
this biomarker in the specific COU is not limited to a single, specific
drug development program. Making the qualification recommendations
widely known and available for use by drug developers will contribute
to drug innovation, thus supporting public health.
    As stated previously, in the Federal Register of January 7, 2014
(79 FR 831), FDA announced the availability of a final guidance for
industry entitled ``Qualification Process for Drug Development Tools''
that described the process that would be used to qualify DDTs and to
make new DDT qualification recommendations available on FDA's Web site
at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm. The current draft guidance is an attachment to
that final guidance.
    CDER has initiated this formal qualification process to work with
developers of these biomarker DDTs to guide them as they refine and
evaluate DDTs for use in the regulatory context. Once qualified, DDTs
will be publicly available for use in any drug development program for
the qualified COU. As described in the January 2014 guidance, biomarker
DDTs should be developed and reviewed using this process. For more
information on FDA's DDTs Qualification Programs, refer to the
following Web site: http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DrugDevelopmentToolsQualificationProgram/default.htm.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the Agency's current thinking on the use of
plasma fibrinogen as an enrichment biomarker in interventional clinical
trials of COPD patients. 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.

II. The Paperwork Reduction Act of 1995

    This guidance contains an information collection that is 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 information collection
has been approved under the OMB control numbers 0910-0001 and 0910-
0014. The information requested in this guidance is currently submitted
to FDA to support medical product effectiveness (see 21 CFR 312.30, 21
CFR 314.50(d)(5), and 21 CFR 314.126(b)(6)).

III. Comments

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

IV. Electronic Access

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

    Dated: June 30, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-16563 Filed 7-6-15; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 83, Number 114 (Wednesday, June 13, 2018)]
[Notices]
[Pages 27618-27619]
[FR Doc No: 2018-12636]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-1893]

Patient-Focused Drug Development: Collecting Comprehensive and
Representative Input; Draft Guidance for Industry, Food and Drug
Administration Staff, and Other Stakeholders; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry, FDA staff, and other
stakeholders entitled ``Patient-Focused Drug Development: Collecting
Comprehensive and Representative Input.'' This guidance (Guidance 1) is
the first of a series of four methodological guidance documents that
FDA committed to develop to address in a stepwise manner how to collect
and submit information from patients and caregivers for medical product
development and regulatory decision making.

DATES: Submit either electronic or written comments on the draft
guidance by September 11, 2018 to ensure that the Agency considers your
comment on this draft 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-2018-D-1893 for ``Patient-Focused Drug Development: Collecting
Comprehensive and Representative Input; Draft Guidance for Industry,
Food and Drug Administration Staff, and Other Stakeholders;
Availability.'' 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 guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one
self-addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Meghana Chalasani, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 1146, Silver Spring, MD 20993-0002, 240-
402-6525, Fax:<PHONE_NUMBER>, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing availability of a draft guidance for industry,
FDA staff, and other stakeholders entitled ``Patient-Focused Drug
Development: Collecting Comprehensive and Representative Input.'' This
guidance (Guidance 1) is the first of a series of four guidance
documents that FDA committed to develop to address in a stepwise manner
how stakeholders (patients, researchers, medical product developers,
and others) can collect and submit information from patients and
caregivers for medical product development and regulatory decision
making. This series of guidance documents is intended to facilitate the
advancement and use of systematic approaches to collect and use robust
and meaningful patient and caregiver input that can more consistently
inform medical product development and regulatory decision making. The
purpose of Guidance 1 is to present methods for collecting information
on the patient experience that is representative of the intended
population to inform the development and evaluation of medical products

throughout the medical product lifecycle. In addition, this document
discusses methods on how to operationalize and standardize the
collection, analysis, and dissemination of patient experience data.
Guidance 1 also includes a glossary of terms that will be used in one
or more of the series of four guidance documents.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on ``Patient-
Focused Drug Development: Collecting Comprehensive and Representative
Input.'' 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.

II. Additional Information

    Section 3002 of Title III, Subtitle A of the 21st Century Cures Act
(Pub. L. 114-255) directs FDA to develop patient-focused drug
development guidance to address a number of areas, including under
section 3002(c)(1) (methodological approaches), which are relevant and
objective and ensure that such data are accurate and representative of
the intended population, that a person seeking to collect patient
experience data to inform regulatory decision making may use.
    In addition, FDA committed to meet certain performance goals under
the sixth authorization of the Prescription Drug User Fee Act. These
goal commitments were developed in consultation with patient and
consumer advocates, healthcare professionals, and other public
stakeholders, as part of negotiations with regulated industry. Section
I.J.1. of the commitment letter, ``Enhancing the Incorporation of the
Patient's Voice in Drug Development and Decision-Making,'' (https://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM511438.pdf) outlines work, including the development of a series of
guidance documents and associated public workshops to facilitate the
advancement and use of systematic approaches to collect and utilize
robust and meaningful patient and caregiver input that can more
consistently inform drug development, and, as appropriate, regulatory
decision making.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance
at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://www.regulations.gov.

    Dated: June 7, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-12636 Filed 6-12-18; 8:45 am]
 BILLING CODE 4164-01-P


			  UNITED STATES OF AMERICA

		        DEPARTMENT OF TRANSPORTATION

			  OFFICE OF THE SECRETARY

			          WASHINGTON, D.C.

Issued by the Department of Transportation on June 27XX, 2005

NOTICE OF ACTION TAKEN -- DOCKET OST 2005-21592335

________________________________________________________________________
________________________________________________________

This serves as notice to the public of the action described below, taken
by the Department official indicated

(no additional confirming order will be issued in this matter).

Applicant:  VOLGA-DNEPR J.S. CARGO AIRLINE (Volga-Dnepr)						Date
Filed:  June 15, May 26, 2005

Relief requested:  Exemption from from 49 U.S.C. section 40109(g) to
permit the applicant to operate one round-trip,       one-way,
all--cargo charter flight between North Island NAS, California and
Denver, Colorado Denver, Colorado and Cape Canaveral, Florida within
during the periodon or around  of June 29-306-14, 2005, using it’s
AN-124-100 aircraft to transport one Centaur III Launch Vehicle Upper
Stage as well as 26,000 pounds of associated ground support equipment on
behalf of Lockheed Martin Space Systems (LMSS).  twoone cLockheed Martin
Space System Centaur tTank each way Upper Stages on behalf of Lockheed
Martin Space Systems (LMSS). ThThee applicant statesd that LMSS needs
the subject lift in order to meet an aggressive final assembly schedule;
that the cargo is too large for transportation by U.S.-carrier aircraft;
and that surface transportation is not feasible because of the delicate
nature of the cargo.

LMSSockheed Martin needsed urgent delivery of the equipmentthe subject
lift in order to meet an aggressive integration and launch schedules
that include subsequent launch integration activities and launch
processing; that the cargo is too large for transportation by
U.S.-carrier aircraft; and that a technical evaluation conducted by
Lockheed Martin determined that surface transportation is not feasible
because of the delicate nature of the cargowould place the cargo in
conditions that are unsuitable to maintaining system integrity.

Applicant representative:  Glenn P. Wicks,<PHONE_NUMBER>
DOT analyst:  Daniel M. Wolfert,<PHONE_NUMBER>

Responsive pleadings:  The applicantVolga-Dnepr served its application
on those U.S. carriers operating large all-cargo aircraft.  Each carrier
indicated that it did not have aircraft available to conduct the
proposed operations and that it had no comment or did not oppose grant
of the requested authority to Volga-Dnepr.

Statutory Standards:  Under 49 U.S.C. section 40109(g), we may authorize
a foreign air carrier to carry commercial traffic between U.S. points
(i.e., cabotage traffic) under limited circumstances.  Specifically, we
must find that the authority is required in the public interest; that
because of an emergency created by unusual circumstances not arising in
the normal course of business the traffic cannot be accommodated by U.S.
carriers holding certificates under 49  U.S.C. section 41102; that all
possible efforts have been made to place the traffic on U.S. carriers;
and that the transportation is necessary to avoid unreasonable hardship
to the traffic involved (an additional required finding, concerning
emergency transportation during labor disputes, was not relevant here).

        DISPOSITION

Action: Approved.
                                                	Action date:  June
27XX,, 2005

Effective dates of authority granted:  June 296x, 2005, through June
3014, 2005.

Basis for approval:  We are granting Volga-Dnepr Airline’s request to
operate its proposed one-way round-trip operation (described above)
between Denver, Colorado and Cape Canaveral, Floridaon behalf of of LMSS
June 29 through June 30, 2005.  We LMSS, through June 14, 2005.  We
found that this request met all the relevant criteria of 49  U.S.C.
section 40109(g) for the grant of an exemption of this type and that the
grant was required in the public interest.  Specifically, we were
persuaded that the need to move the cargo promptly in order to meet the
shipper’s final assembly and launch schedules associated with the
cargo, the fact that the cargo could not be transported by surface
transportation because of its delicate nature, and the unique, outsized
nature of the cargo, constituted an emergency not arising in the normal
course of business.  Moreover, based on the representations of the U.S.
carriers, we concluded that no U.S. carrier had aircraft available which
could be used to conduct the operation at issue here.  We also found
that grant of this authority was necessary to prevent unreasonable
hardship to LMSS.  Finally, we found that the applicant was qualified to
perform its proposed operation.

  Specifically, we were persuaded of the urgent that the need to move
the cargo promptly in order to meet the shipper’s integration and
launch schedules associated with the cargodelivery schedule, the fact
that the cargo could not be transported by surface transportation
because of its delicate naturethe potential negative impact of delivery
delay; and the unique, outsized nature of the cargo, constituted an
emergency not arising in the normal course of business.  Moreover, based
on the representations of the U.S. carriers, we concluded that no U.S.
carrier had aircraft available which could be used to conduct the
operation at issue here.  We also found that grant of this authority was
necessary to prevent unreasonable hardship to Lockheed MartinMSS.
Finally, we found that the applicant was qualified to perform its
proposed operation.

Except to the extent exempted/waived, this authority is subject to our
standard exemption conditions (attached) and to the condition that the
applicant must comply with an FAA-approved flight routing for the
authorized flightoperation.

Action taken by:

Karan K. Bhatia

Assistant Secretary

for Aviation and International Affairs

An electronic version of this document is available on the World Wide
Web at:

http://dms.dot.gov//reports/reports_aviation.asp

FOREIGN CARRIER EXEMPTION CONDITIONS
                               ATTACHMENT

In the conduct of the operations authorized, the foreign carrier
applicant(s) shall:

1) Not conduct any operations unless it holds a currently effective
authorization from its homeland for such operations, and it has filed a
copy of such authorization with the Department;

2) Comply with all applicable requirements of the Federal Aviation
Administration, including, but not limited to, 14 CFR Parts 129, 91, and
36, and with all applicable U.S. Government requirements concerning
security, including, but not limited to, 49 CFR Part 1546 or 1550, as
applicable.  To assure compliance with all applicable U.S. Government
requirements concerning security, the holder shall, before commencing
any new service (including charter flights) from a foreign airport that
would be the holder’s last point of departure for the United States,
contact its International Principal Security Inspector (IPSI) to advise
the IPSI of its plans and to find out whether the Transportation
Security Administration has determined that security is adequate to
allow such airport(s) to be served;

3) Comply with the requirements for minimum insurance coverage contained
in 14 CFR Part 205, and, prior to the commencement of any operations
under this authority, file evidence of such coverage, in the form of a
completed OST Form 6411, with the Federal Aviation Administration’s
Program Management Branch (AFS-260), Flight Standards Service (any
changes to, or termination of, insurance also shall be filed with that
office);

4) Not operate aircraft under this authority unless it complies with
operational safety requirements at least equivalent to Annex 6 of the
Chicago Convention;

5) Conform to the airworthiness and airman competency requirements of
its Government for international air services;

6) Except as specifically exempted or otherwise provided for in a
Department Order, comply with the requirements of 14 CFR Part 203,
concerning waiver of Warsaw Convention liability limits and defenses;

7) Agree that operations under this authority constitute a waiver of
sovereign immunity, for the purposes of 28 U.S.C. 1605(a), but only with
respect to those actions or proceedings instituted against it in any
court or other tribunal in the United States that are: a) based on its
operations in international air transportation that, according to the
contract of carriage, include a point in the United States as a point of
origin, point of destination, or agreed stopping place, or for which the
contract of carriage was purchased in the United States; or b) based on
a claim under any international agreement or treaty cognizable in any
court or other tribunal of the United States.  In this condition, the
term “international air transportation” means “international
transportation” as defined by the Warsaw Convention, except that all
States shall be considered to be High Contracting Parties for the
purpose of this definition;

8) Except as specifically authorized by the Department, originate or
terminate all flights to/from the United States in its homeland;

9) Comply with the requirements of 14 CFR Part 217, concerning the
reporting of scheduled, nonscheduled, and charter data;

10) If charter operations are authorized, except as otherwise provided
in the applicable aviation agreement, comply with the Department’s
rules governing charters (including 14 CFR Parts 212 and 380); and

11) Comply with such other reasonable terms, conditions, and limitations
required by the public interest as may be prescribed by the Department,
with all applicable orders or regulations of other U.S. agencies and
courts, and with all applicable laws of the United States.

This authority shall not be effective during any period when the holder
is not in compliance with the conditions imposed above.  Moreover, this
authority cannot be sold or otherwise transferred without explicit
Department approval under Title 49 of the U.S. Code.

 05/2004