[Federal Register Volume 82, Number 84 (Wednesday, May 3, 2017)]
[Notices]
[Pages 20664-20671]
[FR Doc No: 2017-08904]

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

SECURITIES AND EXCHANGE COMMISSION

[Investment Company Act Release No. 32615; File No. 812-14646]

Commonwealth Annuity and Life Insurance Company, et al.

April 27, 2017.
AGENCY: Securities and Exchange Commission (``SEC'' or ``Commission'').

ACTION: Notice.

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

    Notice of application for an order approving the substitution of
certain securities pursuant to Section 26(c) of the Investment Company
Act of 1940, as amended (the ``1940 Act'' or ``Act'') and an order of
exemption pursuant to Section 17(b) of the Act from Section 17(a) of
the Act.

Applicants: Commonwealth Annuity and Life Insurance Company
(``Commonwealth'') and Commonwealth Select Separate Account of
Commonwealth Annuity and Life Insurance Company, Commonwealth Select
Separate Account II of Commonwealth Annuity and Life Insurance Company,
Commonwealth Select Separate Account III of Commonwealth Annuity and
Life Insurance Company, Fulcrum Separate Account of Commonwealth
Annuity and Life Insurance Company, Group VEL Account of Commonwealth
Annuity and Life Insurance Company, Inheritage Account of Commonwealth
Annuity and Life Insurance Company, Separate Account FUVUL of
Commonwealth Annuity and Life Insurance Company, Separate Account IMO
of Commonwealth Annuity and Life Insurance Company, Separate Account KG
of Commonwealth Annuity and Life Insurance Company, Separate Account
KGC of Commonwealth Annuity and Life Insurance Company, Separate
Account VA-K of Commonwealth Annuity and Life Insurance Company,
Separate Account VA-P of Commonwealth Annuity and Life Insurance
Company, Separate Account VEL of Commonwealth Annuity and Life
Insurance Company, Separate Account VEL II of Commonwealth Annuity and
Life Insurance Company, Separate Account VEL III of Commonwealth
Annuity and Life Insurance Company (collectively, the ``Separate
Accounts,'' and together with Commonwealth, the ``Section 26
Applicants''); and Forethought Variable Insurance Trust (the
``Trust''), and Global Atlantic Investment Advisors, LLC (``Global
Atlantic,'' and collectively with the Section 26 Applicants, the
``Section 17 Applicants'').

Summary of Application: The Section 26 Applicants seek an order
pursuant to Section 26(c) of the 1940 Act, approving the substitution
of shares of 77 investment portfolios (each, an ``Existing Portfolio,''
and collectively, the ``Existing Portfolios'') of 20 registered
investment companies \1\ with shares of 13 investment portfolios (each,
a ``Replacement Portfolio,'' and collectively, the ``Replacement
Portfolios'') of the Trust, under certain variable annuity contracts
and variable life insurance policies (the ``Contracts'') funded through
the Separate Accounts.
---------------------------------------------------------------------------

    \1\ (1) AB Variable Products Series Fund, Inc. (File Nos. 811-
05398; 033-18647); (2) Alger Portfolios (File Nos. 811-05550; 033-
21722); (3) AIM Variable Insurance Funds (Invesco Variable Insurance
Funds) (File Nos. 811-07452; 033-57340); (4) Delaware VIP Trust
(File Nos. 811-05162; 033-14363); (5) Deutsche Variable Series I
(File Nos. 811-04257; 002-96461); (6) Deutsche Variable Series II
(File Nos. 811-05002; 033-11802); (7) Dreyfus Investment Portfolios
(File Nos. 811-08673; 333-47011); (8) Fidelity Variable Insurance
Products Fund I (File Nos. 811-03329; 002-75010); (9) Fidelity
Variable Insurance Products Fund II (File Nos. 811-05511; 033-
20773); (10) Fidelity Variable Insurance Products Fund III (File
Nos. 811-07205; 033-54837); (11) Fidelity Variable Insurance
Products Fund V (File Nos. 811-05361; 033-17704); (12) Franklin
Templeton Variable Insurance Products Trust (File Nos. 811-05583;
033-23493); (13) Goldman Sachs Variable Insurance Trust (File Nos.
811-08361; 333-35883); (14) Janus Aspen Portfolio (File Nos. 811-
07736; 033-63212); (15) Lazard Retirement Series, Inc. (File Nos.
811-08071; 333-22309); (16) Lincoln Variable Insurance Products
Trust (File Nos. 811-08090; 033-70742); (17) MFS Variable Insurance
Trust (File Nos. 811-08326; 033-74668); (18) Oppenheimer Variable
Account Funds (File Nos. 811-04108; 002-93177); (19) Pioneer
Variable Contracts Trust (File Nos. 811-08786; 033-84546); (20) T.
Rowe Price International Series, Inc. (File Nos. 811-07145; 033-
07145).

Filing Date: The application was filed on April 29, 2016, and was
---------------------------------------------------------------------------
amended and restated on October 18, 2016 and March 3, 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 Secretary of
the Commission and serving the 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 May 22, 2017 and should be accompanied by
proof of service on the Applicants in the form of an affidavit or, for
lawyers, a certificate of service. Pursuant to Rule 0-5 under the Act,
hearing requests should state the nature of the writer's interest, any
facts bearing upon the desirability of a hearing on the matter, the
reason for the request, and the issues contested. Persons who wish to
be notified of a hearing may request notification by writing to the
Commission's Secretary.

ADDRESSES:
    Commission: Secretary, SEC, 100 F Street NE., Washington, DC 20549-
1090.
    Applicants: Commonwealth Annuity and Life Insurance Company,
Commonwealth Select Separate Account of Commonwealth Annuity and Life
Insurance Company, Commonwealth Select Separate Account II of
Commonwealth Annuity and Life Insurance Company, Commonwealth Select
Separate Account III of Commonwealth Annuity and Life Insurance
Company, Fulcrum Separate Account of Commonwealth Annuity and Life
Insurance Company, Group VEL Account of Commonwealth Annuity and Life
Insurance Company, Inheritage Account of Commonwealth Annuity and Life
Insurance Company, Separate Account FUVUL of Commonwealth Annuity and
Life Insurance Company, Separate Account IMO of Commonwealth Annuity
and Life Insurance Company, Separate Account KG of Commonwealth Annuity
and Life Insurance Company, Separate Account KGC of Commonwealth
Annuity and Life Insurance Company, Separate Account VA-K of
Commonwealth Annuity and Life Insurance Company, Separate Account VA-P
of Commonwealth Annuity and Life Insurance Company, Separate Account
VEL of Commonwealth Annuity and Life Insurance Company, Separate
Account VEL II of Commonwealth Annuity and Life Insurance Company,
Separate Account VEL III of Commonwealth Annuity and Life Insurance
Company, 132 Turnpike Road Suite 210, Southborough, MA 01772; and
Forethought Variable Insurance Trust and Global Atlantic Investment
Advisors, LLC, 300 N. Meridian Street, Suite 1800, Indianapolis, IN,
46204.

FOR FURTHER INFORMATION CONTACT: Erin C. Loomis, Senior Counsel, at
(202) 551-6721, or Holly Hunter-Ceci, Acting Assistant Chief Counsel at
(202) 551-6825 (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. Commonwealth is a life insurance company engaged in the business
of writing individual and group annuity contracts and life insurance
policies. Commonwealth was originally organized under the laws of
Delaware in July 1974 and was subsequently re-domiciled in the state of
Massachusetts effective December 31, 2002.
    2. Prior to December 30, 2005, Commonwealth (formerly Allmerica
Financial Life Insurance and Annuity Company) was an indirect wholly-
owned subsidiary of The Hanover Insurance Group (``THG''), formerly
Allmerica Financial Corporation. On that date, THG completed the
closing of the sale of Commonwealth to The Goldman Sachs Group, Inc.
(``Goldman Sachs''). Effective September 1, 2006, Commonwealth changed
its name from Allmerica Financial Life Insurance and

Annuity Company to Commonwealth Annuity and Life Insurance Company.
Effective April 30, 2013, Goldman Sachs completed the transfer of the
common stock of Commonwealth to Global Atlantic (Fin) Company, which is
a wholly-owned indirect subsidiary of Global Atlantic Financial Group
Limited. Effective January 2, 2014, Forethought Services LLC acquired
ownership of 79% of the shares of Commonwealth. Forethought Services
LLC is a wholly-owned subsidiary of Forethought Financial Group, Inc.,
which in turn is a wholly-owned subsidiary of Global Atlantic (Fin)
Company. As of December 31, 2015, Goldman Sachs owns a total of
approximately 22% of the outstanding shares of Global Atlantic; and
other investors, none of whom own more than 9.9%, own the remaining 78%
of the outstanding ordinary shares.
    3. Each of the Separate Accounts meets the definition of ``separate
account,'' as defined in Section 2(a)(37) of the 1940 Act and Rule 0-
1(e) thereunder. The Separate Accounts are registered with the
Commission under the 1940 Act as unit investment trusts. The assets of
the Separate Accounts support the Contracts and interests in the
Separate Accounts offered through such Contracts. Commonwealth is the
legal owner of the assets in the Separate Accounts. The Separate
Accounts are segmented into subaccounts, and each subaccount invests in
an underlying registered open-end management investment company or a
series thereof. A subaccount of one or more of the Separate Accounts
corresponds to each of the Existing Portfolios. The business and
affairs of the Separate Accounts, as unit investment trusts, are
conducted by Commonwealth, as depositor thereof.
    4. The Contracts are each registered under the Securities Act of
1933, as amended (the ``1933 Act''), on Form N-4 or Form N-6, as
applicable. Each of the Contracts has particular fees, charges, and
investment options, as described in the Contracts' respective
registration statements.
    5. The Contracts are individual or group deferred variable annuity
contracts or variable life insurance policies. As set forth in the
prospectuses for the Contracts, Commonwealth reserves the right to
substitute shares of another registered investment company for the
shares of any registered investment company already purchased or to be
purchased in the future by the Separate Accounts.
    6. Applicants propose, as set forth below, to substitute shares of
the Replacement Portfolios for shares of the Existing Portfolios
(``Substitutions''):

------------------------------------------------------------------------
           Existing portfolio                 Replacement portfolio
------------------------------------------------------------------------
AB Large Cap Growth Portfolio (Class A)  Global Atlantic BlackRock
                                          Disciplined Core Portfolio
                                          (Class I).
AB Large Cap Growth Portfolio (Class B)  Global Atlantic BlackRock
                                          Disciplined Core Portfolio
                                          (Class I, II).
Deutsche Core Equity VIP (Class A).....  Global Atlantic BlackRock
                                          Disciplined Core Portfolio
                                          (Class I).
Delaware VIP U.S. Growth Series          Global Atlantic BlackRock
 (Standard Class).                        Disciplined Core Portfolio
                                          (Class I).
Fidelity VIP Contrafund Portfolio        Global Atlantic BlackRock
 (Initial Class).                         Disciplined Core Portfolio
                                          (Class I).
Fidelity VIP Contrafund Portfolio        Global Atlantic BlackRock
 (Service Class 2).                       Disciplined Core Portfolio
                                          (Class I, Class II).
Fidelity VIP Growth Portfolio (Initial   Global Atlantic BlackRock
 Class).                                  Disciplined Core Portfolio
                                          (Class I).
Fidelity VIP Growth Portfolio (Service   Global Atlantic BlackRock
 Class 2).                                Disciplined Core Portfolio
                                          (Class I, Class II).
Fidelity VIP Growth & Income Portfolio   Global Atlantic BlackRock
 (Initial Class, Service Class 2).        Disciplined Core Portfolio
                                          (Class I).
Fidelity VIP Growth Opportunities        Global Atlantic BlackRock
 Portfolio (Service Class 2).             Disciplined Core Portfolio
                                          (Class I).
Franklin Large Cap Growth VIP Fund       Global Atlantic BlackRock
 (Class 2).                               Disciplined Core Portfolio
                                          (Class I, Class II).
Goldman Sachs Strategic Growth Fund      Global Atlantic BlackRock
 (Service Shares).                        Disciplined Core Portfolio
                                          (Class I, Class II).
Goldman Sachs U.S. Equity Insights Fund  Global Atlantic BlackRock
 (Service Shares).                        Disciplined Core Portfolio
                                          (Class I, Class II).
Invesco V.I. American Franchise Fund     Global Atlantic BlackRock
 (Series I).                              Disciplined Core Portfolio
                                          (Class I, II).
Invesco V.I. American Franchise Fund     Global Atlantic BlackRock
 (Series II).                             Disciplined Core Portfolio
                                          (Class II).
Invesco V.I. Core Equity Fund (Series    Global Atlantic BlackRock
 I).                                      Disciplined Core Portfolio
                                          (Class I).
Invesco V.I. Core Equity Fund (Series    Global Atlantic BlackRock
 II).                                     Disciplined Core Portfolio
                                          (Class II).
MFS Growth Series (Initial Class)......  Global Atlantic BlackRock
                                          Disciplined Core Portfolio
                                          (Class I).
MFS Investors Trust Series (Initial      Global Atlantic BlackRock
 Class).                                  Disciplined Core Portfolio
                                          (Class I).
Oppenheimer Capital Appreciation Fund/   Global Atlantic BlackRock
 VA (Service Shares).                     Disciplined Core Portfolio
                                          (Class I, Class II).
Pioneer Fund VCT Portfolio (Class I)...  Global Atlantic BlackRock
                                          Disciplined Core Portfolio
                                          (Class II).
Pioneer Fund VCT Portfolio (Class II)..  Global Atlantic BlackRock
                                          Disciplined Core Portfolio
                                          (Class I).
Alger Capital Appreciation Portfolio     Global Atlantic BlackRock
 (Class I-2).                             Disciplined Growth Portfolio
                                          (Class II).
Deutsche CROCI International VIP (Class  Global Atlantic BlackRock
 A).                                      Disciplined International Core
                                          Portfolio (Class I).
Delaware VIP International Value Equity  Global Atlantic BlackRock
 Series (Standard Class, Service Class).  Disciplined International Core
                                          Portfolio (Class I, Class II).
Fidelity VIP Overseas Portfolio          Global Atlantic BlackRock
 (Initial Class).                         Disciplined International Core
                                          Portfolio (Class I).
Invesco V.I. International Growth Fund   Global Atlantic BlackRock
 (Series I).                              Disciplined International Core
                                          Portfolio (Class I).
Goldman Sachs Strat. International       Global Atlantic BlackRock
 Equity Fund (Service Shares).            Disciplined International Core
                                          Portfolio (Class I, Class II).
Lazard Retirement International Equity   Global Atlantic BlackRock
 Portfolio (Service Shares).              Disciplined International Core
                                          Portfolio (Class II).
T. Rowe Price International Stock        Global Atlantic BlackRock
 Portfolio.                               Disciplined International Core
                                          Portfolio (Class I, Class II).
Templeton Foreign VIP Fund (Class 2)...  Global Atlantic BlackRock
                                          Disciplined International Core
                                          Portfolio (Class I, Class II).
AB Growth and Income Portfolio (Class    Global Atlantic BlackRock
 B).                                      Disciplined Value Portfolio
                                          (Class I, Class II).
AB Value Portfolio (Class B)...........  Global Atlantic BlackRock
                                          Disciplined Value Portfolio
                                          (Class I, Class II).
Deutsche Large Cap Value VIP (Class A).  Global Atlantic BlackRock
                                          Disciplined Value Portfolio
                                          (Class I).
Fidelity VIP Equity-Income Portfolio     Global Atlantic BlackRock
 (Initial Class).                         Disciplined Value Portfolio
                                          (Class I).
Fidelity VIP Equity-Income Portfolio     Global Atlantic BlackRock
 (Service Class 2).                       Disciplined Value Portfolio
                                          (Class I, Class II).
Franklin Mutual Shares VIP Fund (Class   Global Atlantic BlackRock
 2).                                      Disciplined Value Portfolio
                                          (Class I, Class II).
Franklin Growth & Income VIP Fund        Global Atlantic BlackRock
 (Class 2).                               Disciplined Value Portfolio
                                          (Class I).
Invesco V.I. Value Opportunities Fund    Global Atlantic BlackRock
 (Series II).                             Disciplined Value Portfolio
                                          (Class I, Class II).
Pioneer Equity Income VCT Portfolio      Global Atlantic BlackRock
 (Class I)..                              Disciplined Value Portfolio
                                          (Class I).

Alger Mid Cap Growth Portfolio (Class I- Global Atlantic BlackRock
 2).                                      Disciplined Mid Cap Growth
                                          Portfolio (Class I).
Deutsche Small Mid Cap Growth VIP        Global Atlantic BlackRock
 (Class A).                               Disciplined Mid Cap Growth
                                          Portfolio (Class I).
Delaware VIP Smid Cap Growth Series      Global Atlantic BlackRock
 (Standard Class).                        Disciplined Mid Cap Growth
                                          Portfolio (Class I).
Delaware VIP Smid Cap Growth Series      Global Atlantic BlackRock
 (Service Class).                         Disciplined Mid Cap Growth
                                          Portfolio (Class I, Class II).
Fidelity VIP Mid Cap Portfolio (Initial  Global Atlantic BlackRock
 Class, Service Class 2).                 Disciplined Mid Cap Growth
                                          Portfolio (Class I).
Franklin Small-Mid Cap Growth VIP Fund   Global Atlantic BlackRock
 (Class 2).                               Disciplined Mid Cap Growth
                                          Portfolio (Class I, Class II).
Invesco V.I. Mid Cap Growth Fund         Global Atlantic BlackRock
 (Series I, Series II).                   Disciplined Mid Cap Growth
                                          Portfolio (Class I).
Goldman Sachs Growth Opportunities Fund  Global Atlantic BlackRock
 (Service Shares).                        Disciplined Mid Cap Growth
                                          Portfolio (Class I, Class II).
Janus Aspen Enterprise Portfolio         Global Atlantic BlackRock
 (Service Shares).                        Disciplined Mid Cap Growth
                                          Portfolio (Class I).
MFS Mid Cap Growth Series (Service       Global Atlantic BlackRock
 Class).                                  Disciplined Mid Cap Growth
                                          Portfolio (Class I, Class II).
Alger Small Cap Growth Portfolio (Class  Global Atlantic BlackRock
 I-2).                                    Disciplined Small Cap
                                          Portfolio (Class I).
Delaware VIP Small Cap Value Series      Global Atlantic BlackRock
 (Standard Class).                        Disciplined Small Cap
                                          Portfolio (Class I).
Franklin Small Cap Value VIP Fund        Global Atlantic BlackRock
 (Class 2).                               Disciplined Small Cap
                                          Portfolio (Class II).
MFS New Discovery Series (Service        Global Atlantic BlackRock
 Class).                                  Disciplined Small Cap
                                          Portfolio (Class II).
AB Growth Portfolio (Class B)..........  Global Atlantic BlackRock
                                          Disciplined U.S. Core
                                          Portfolio (Class I, Class II).
Delaware VIP Value Series (Standard      Global Atlantic BlackRock
 Class).                                  Disciplined U.S. Core
                                          Portfolio (Class I).
Oppenheimer Main Street Fund/VA (Non-    Global Atlantic BlackRock
 Service Class, Service Class).           Disciplined U.S. Core
                                          Portfolio (Class II).
AB Global Thematic Growth Portfolio      Global Atlantic Goldman Sachs
 (Class B).                               Global Equity Insights
                                          Portfolio (Class II).
Deutsche Global Equity VIP (Class A)...  Global Atlantic Goldman Sachs
                                          Global Equity Insights
                                          Portfolio (Class I).
Deutsche Global Growth VIP (Class A)...  Global Atlantic Goldman Sachs
                                          Global Equity Insights
                                          Portfolio (Class I).
Oppenheimer Global Fund/VA (Service      Global Atlantic Goldman Sachs
 Shares).                                 Global Equity Insights
                                          Portfolio (Class II).
Templeton Growth VIP Fund (Class 2)....  Global Atlantic Goldman Sachs
                                          Global Equity Insights
                                          Portfolio (Class II).
Alger Large Cap Growth Portfolio (Class  Global Atlantic Goldman Sachs
 I-2).                                    Large Cap Growth Insights
                                          Portfolio (Class II).
Deutsche Capital Growth VIP (Class A)..  Global Atlantic Goldman Sachs
                                          Large Cap Growth Insights
                                          Portfolio (Class I).
Janus Aspen Janus Portfolio              Global Atlantic Goldman Sachs
 (Institutional Shares).                  Large Cap Growth Insights
                                          Portfolio (Class I).
Janus Aspen Janus Portfolio (Service     Global Atlantic Goldman Sachs
 Shares).                                 Large Cap Growth Insights
                                          Portfolio (Class I, Class II).
AB Small/Mid Cap Value Portfolio (Class  Global Atlantic Goldman Sachs
 B).                                      Mid Cap Value Insights
                                          Portfolio (Class II).
Deutsche Small Mid Cap Value VIP (Class  Global Atlantic Goldman Sachs
 A).                                      Mid Cap Value Insights
                                          Portfolio (Class I).
Dreyfus Midcap Stock Portfolio (Initial  Global Atlantic Goldman Sachs
 Shares).                                 Mid Cap Value Insights
                                          Portfolio (Class I).
Fidelity VIP Value Strategies Portfolio  Global Atlantic Goldman Sachs
 (Service Class 2).                       Mid Cap Value Insights
                                          Portfolio (Class II).
Goldman Sachs Mid Cap Value Fund         Global Atlantic Goldman Sachs
 (Service Shares).                        Mid Cap Value Insights
                                          Portfolio (Class II).
Pioneer Mid Cap Value VCT Portfolio      Global Atlantic Goldman Sachs
 (Class I).                               Mid Cap Value Insights
                                          Portfolio (Class I).
Pioneer Mid Cap Value VCT Portfolio      Global Atlantic Goldman Sachs
 (Class II).                              Mid Cap Value Insights
                                          Portfolio (Class II).
Deutsche High Income VIP (Class A).....  Global Atlantic BlackRock High
                                          Yield Portfolio (Class I).
Delaware VIP High Yield Series           Global Atlantic BlackRock High
 (Standard Class).                        Yield Portfolio (Class I).
Fidelity VIP High Income Portfolio       Global Atlantic BlackRock High
 (Initial Class).                         Yield Portfolio (Class I).
Fidelity VIP High Income Portfolio       Global Atlantic BlackRock High
 (Service Class 2).                       Yield Portfolio (Class II).
Invesco V.I. High Yield Fund (Series I)  Global Atlantic BlackRock High
                                          Yield Portfolio (Class I).
Pioneer High Yield VCT Portfolio (Class  Global Atlantic BlackRock High
 I, Class II).                            Yield Portfolio (Class I).
Deutsche Bond VIP (Class A)............  Global Atlantic Goldman Sachs
                                          Core Fixed Income Portfolio
                                          (Class I).
Deutsche Unconstrained Income VIP        Global Atlantic Goldman Sachs
 (Class A).                               Core Fixed Income Portfolio
                                          (Class I).
Goldman Sachs Core Fixed Income Fund     Global Atlantic Goldman Sachs
 (Service Shares).                        Core Fixed Income Portfolio
                                          (Class I).
Pioneer Bond VCT Portfolio (Class I)...  Global Atlantic Goldman Sachs
                                          Core Fixed Income Portfolio
                                          (Class I).
Alger Balanced Portfolio (Class I-2)...  Global Atlantic BlackRock
                                          Allocation Portfolio (Class
                                          I).
Deutsche Global Income Builder VIP       Global Atlantic BlackRock
 (Class A).                               Allocation Portfolio (Class
                                          I).
Fidelity VIP Asset Manager Portfolio     Global Atlantic BlackRock
 (Initial Class).                         Allocation Portfolio (Class
                                          I).
Fidelity VIP Asset Manager Portfolio     Global Atlantic BlackRock
 (Service Class 2).                       Allocation Portfolio (Class
                                          II).

LVIP Delaware Foundation Moderate        Global Atlantic BlackRock
 Allocation Fund (Standard Class).        Allocation Portfolio (Class I,
                                          Class II).
MFS Total Return Series (Service Class)  Global Atlantic BlackRock
                                          Allocation Portfolio (Class I,
                                          Class II).
------------------------------------------------------------------------

    7. The Replacement Portfolios are all series of the Trust. The
Trust is an insurance-dedicated Delaware statutory trust that was
organized on June 17, 2013. The Trust is registered with the Commission
as an open-end management investment company under the 1940 Act (File
No. 811-22865) and its shares are registered under the 1933 Act (File
No. 333-189870). The Trust is a series investment company and currently
has 30 separate portfolios (each, a ``Global Atlantic Fund,'' and
collectively, the ``Global Atlantic Funds''). The following 13 Global
Atlantic Funds comprise the Replacement Portfolios: Global Atlantic
BlackRock Allocation Portfolio, Global Atlantic BlackRock Disciplined
Core Portfolio, Global Atlantic BlackRock Disciplined Growth Portfolio,
Global Atlantic BlackRock International Core Portfolio, Global Atlantic
BlackRock Disciplined Mid Cap Growth Portfolio, Global Atlantic
BlackRock Small Cap Portfolio, Global Atlantic BlackRock U.S. Core
Portfolio, Global Atlantic BlackRock Disciplined Value Portfolio,
Global Atlantic BlackRock High Yield Portfolio, Global Atlantic Goldman
Sachs Core Fixed Income Portfolio, Global Atlantic Goldman Sachs Global
Equity Insights Portfolio, Global Atlantic Goldman Sachs Large Cap
Growth Insights Portfolio, and Global Atlantic Goldman Sachs Mid Cap
Value Insights Portfolio.
    8. Global Atlantic, an Indiana limited liability company and a
registered investment adviser, serves as investment adviser for each of
the Global Atlantic Funds pursuant to an investment advisory agreement
between the Trust, on behalf of each Global Atlantic Fund, and Global
Atlantic.
    9. Each Replacement Portfolio is sub-advised by BlackRock
Investment Management, LLC (``BlackRock'') or Goldman Sachs Asset
Management, L.P. (``GSAM''). BlackRock is a wholly owned subsidiary of
BlackRock, Inc. BlackRock is a registered investment adviser and a
commodity pool operator organized in Princeton, New Jersey. BlackRock,
Inc. and its affiliates had approximately $4.64 trillion in assets
under management as of December 31, 2015. BlackRock is located at 1
University Square, Princeton, NJ 08536. GSAM is a wholly-owned
subsidiary of The Goldman Sachs Group, Inc. and an affiliate of Goldman
Sachs. As of December 31, 2015, GSAM, including its investment advisory
affiliates, had assets under supervision of approximately $1.08
trillion. GSAM's principal offices are located at 200 West Street, New
York, NY 20182.
    10. The Applicants believe that the Replacement Portfolios have
investment objectives, principal investment strategies, and principle
risks, as described in their prospectuses, that are substantially
similar to, the corresponding Existing Portfolios to make those
Replacement Portfolios appropriate candidates as substitutes.
    11. Information for each Existing Portfolio and Replacement
Portfolio, including investment objectives, principal investment
strategies, principal risks, and comparative performance history, can
be found in the application.
    12. Applicants state that in selecting the Replacement Portfolios,
Commonwealth sought to simplify fund lineups while reducing costs and
maintaining a high-quality menu of investment options that would offer
a similar diversity of investment options after the proposed
Substitutions as is currently available under the Contracts. Contract
owners with Contract value allocated to the subaccounts of the Existing
Portfolios will have lower or equal net annual operating expenses
immediately after the proposed Substitutions as before the proposed
Substitutions. With respect to all of the proposed Substitutions, the
combined management fee and Rule 12b-1 fees paid by the Replacement
Portfolio are the same or lower than those of the corresponding
Existing Portfolio. The application sets forth the fees and expenses of
each Existing Portfolio and its corresponding Replacement Portfolio in
greater detail.
    13. Applicants represent that as of the Substitution Date (defined
below), the Separate Accounts will redeem shares of the Existing
Portfolios for cash or in-kind. Redemption requests and purchase orders
will be placed simultaneously so that Contract values will remain fully
invested at all times.
    14. Each Substitution will be effected at the relative net asset
values of the respective shares of the Replacement Portfolios in
conformity with Section 22(c) of the 1940 Act and Rule 22c-1 thereunder
without the imposition of any transfer or similar charges by the
Section 26 Applicants. The Substitutions will be effected without
change in the amount or value of any Contracts held by affected
Contract owners.\2\
---------------------------------------------------------------------------

    \2\ The Section 26 Applicants state that, because the
Substitutions will occur at relative net asset value, and the fees
and charges under the Contracts will not change as a result of the
Substitutions, the benefits offered by the guarantees under the
Contracts will be the same immediately before and after the
Substitutions. The Section 26 Applicants also state that what effect
the Substitutions may have on the value of the benefits offered by
the Contract guarantees would depend, among other things, on the
relative future performance of the Existing Portfolios and
Replacement Portfolios, which the Section 26 Applicants cannot
predict. Nevertheless, the Section 26 Applicants note that at the
time of the Substitutions, the Contracts will offer a comparable
variety of investment options with as broad a range of risk/return
characteristics.
---------------------------------------------------------------------------

    15. Contract owners will not incur any fees or charges as a result
of the proposed Substitutions. The obligations of the Section 26
Applicants, and the rights of the affected Contract owners, under the
Contracts of affected Contract owners will not be altered in any way.
Commonwealth and/or its affiliates will pay all expenses and
transaction costs of the Substitutions, including legal and accounting
expenses, any applicable brokerage expenses and other fees and
expenses. No fees or charges will be assessed to the affected Contract
owners to effect the Substitutions. The proposed Substitutions will not
cause the Contract fees and charges currently being paid by Contract
owners to be greater after the proposed Substitution than before the
proposed Substitution. In addition, the Substitutions will in no way
alter the tax treatment of affected Contract owners in connection with
their Contracts, and no tax liability will arise for Contract owners as
a result of the Substitutions.
    16. The Section 26 Applicants agree that, for a period of two years
following the implementation of the proposed Substitution (the
``Substitution Date''), and for those Contracts with assets allocated
to the Existing Portfolio on the Substitution Date, Commonwealth or an
affiliate thereof (other than the Trust) will reimburse, on the last
business day of each fiscal quarter, the Contract owners whose
subaccounts invest in the applicable Replacement Portfolio to the
extent that the Replacement Portfolio's net annual operating expenses
(taking into account fee waivers and expense reimbursements) for such
period exceeds, on an annualized basis, the net annual operating
expenses of the

Existing Portfolio for the most recent fiscal year preceding the date
of the most recently filed application. Commonwealth will not increase
the Contract fees and charges that would otherwise be assessed under
the terms of the Contracts for a period of at least two years following
the Substitution Date.
    17. From the date the Pre-Substitution Notice (defined below)
through 30 days following the Substitution Date, Contract owners may
make at least one transfer of Contract value from the subaccount
investing in an Existing Portfolio (before the Substitution) or the
Replacement Portfolio (after the Substitution) to any other available
subaccount under the Contract without charge and without imposing any
transfer limitations. Further, on the Substitution Date, Contract
values attributable to investments in each Existing Portfolio will be
transferred to the corresponding Replacement Portfolio without charge
and without being subject to any transfer limitations. Moreover,
Commonwealth will not exercise any rights reserved under the Contracts
to impose restrictions on transfers between the subaccounts under the
Contracts, including limitations on the future number of transfers, for
a period beginning at least 30 days before the Substitution Date
through at least 30 days following the Substitution Date.
    18. At least 30 days prior to the Substitution Date, Contract
owners will be notified via prospectus supplements that the Section 26
Applicants received or expect to receive Commission approval of the
applicable proposed Substitutions and of the anticipated Substitution
Date (the ``Pre-Substitution Notice''). Pre-Substitution Notices sent
to Contract owners will be filed with the Commission pursuant to Rule
497 under the 1940 Act. The Pre-Substitution Notice will advise
Contract owners that from the date of the Pre-Substitution Notice
through the date 30 days after the Substitutions, Contract owners may
make at least one transfer of Contract value from the subaccounts
investing in the Existing Portfolios (before the Substitutions) or the
Replacement Portfolios (after the Substitutions) to any other available
subaccount without charge and without imposing any transfer
limitations. Among other information, the notice will inform affected
Contract owners that that, except as described in the disruptive
transfers or market timing provisions of the relevant prospectus,
Commonwealth will not exercise any rights reserved under the Contracts
to impose restrictions on transfers among the subaccounts under the
Contracts, including limitations on the future number of transfers,
through at least 30 days after the Substitution Date. Additionally, all
affected Contract owners will be sent prospectuses of the applicable
Replacement Portfolios at least 30 days before the Substitution Date.
    19. In addition to the Supplements distributed to the Contract
owners, within five business days after the Substitution Date, Contract
owners whose assets are allocated to a Replacement Portfolio as part of
the proposed Substitutions will be sent a written notice (each, a
``Confirmation'') informing them that the Substitutions were carried
out as previously notified. The Confirmation also will restate the
information set forth in the Pre-Substitution Notice. The Confirmation
will also reflect the values of the Contract owner's positions in the
Existing Portfolio before the Substitution and the Replacement
Portfolio after the Substitution.

Legal Analysis

    1. The Section 26 Applicants request that the Commission issue an
order pursuant to Section 26(c) of the 1940 Act approving the proposed
Substitutions. Section 26(c) of the 1940 Act prohibits any depositor or
trustee of a unit investment trust that invests exclusively in the
securities of a single issuer from substituting the securities of
another issuer without the approval of the Commission. Section 26(c)
provides that such approval shall be granted by order from the
Commission if the evidence establishes that the substitution is
consistent with the protection of investors and the purposes of the
1940 Act.
    2. The Section 26 Applicants submit that the Substitutions meet the
standards set forth in Section 26(c) and that, if implemented, the
Substitutions would not raise any of the concerns that Congress
intended to address when the 1940 Act was amended to include this
provision. Applicants state that each Substitution protects the
Contract owners who have Contract value allocated to an Existing
Portfolio by providing Replacement Portfolios with substantially
similar investment objectives, strategies, and risks, and providing
Contract owners with investment options that would have total and net
annual operating expense ratios that are lower than, or equal to, their
corresponding investment options before the Substitutions.
    3. Commonwealth has reserved the right under the Contracts to
substitute shares of another underlying fund for one of the current
funds offered as an investment option under the Contracts. The
Contracts and the Contracts' prospectuses disclose this right.
    4. The Section 26 Applicants submit that the ultimate effect of the
proposed Substitutions will be to streamline and simplify the
investment line-ups that are available to Contract owners while
reducing expenses and continuing to provide Contract owners with a wide
array of investment options. The Section 26 Applicants state that the
proposed Substitutions will not reduce in any manner the nature or
quality of the available investment options and the proposed
Substitutions also will permit Commonwealth to present information to
its Contract owners in a simpler and more concise manner. The Section
26 Applicants also state it is anticipated that after the proposed
Substitutions, Contract owners will be provided with disclosure
documents that contain a simpler presentation of the available
investment options under the Contracts. The Section 26 Applicants also
assert that the proposed Substitutions are not of the type that Section
26 was designed to prevent because they will not result in costly
forced redemption, nor will they affect other aspects of the Contracts.
In addition, the proposed Substitutions will not adversely affect any
features or riders under the Contracts because none of the features or
riders have any investment restrictions. Accordingly, no Contract owner
will involuntarily lose his or her features or riders as a result of
any proposed Substitution. Moreover, the Section 26 Applicants will
offer Contract owners the opportunity to transfer amounts out of the
affected subaccounts without any cost or other penalty (other than
those necessary to implement policies and procedures designed to detect
and deter disruptive transfer and other ``market timing'' activity)
that may otherwise have been imposed for a period beginning on the date
of the Pre-Substitution Notice (which supplement will be delivered to
the Contract owners at least thirty (30) days before the Substitution
Date) and ending no earlier than thirty (30) days after the
Substitution Date. The proposed Substitutions are also unlike the type
of substitution that Section 26(c) was designed to prevent in that the
Substitutions have no impact on other aspects of the Contracts.
    5. The Section 17 Applicants request an order under Section 17(b)
exempting them from the provisions of Section 17(a) to the extent
necessary to permit the Section 17 Applicants to carry out some or all
of the proposed Substitutions. The Section 17

Applicants state that because the proposed Substitutions may be
effected, in whole or in part, by means of in-kind redemptions and
purchases, the proposed Substitutions may be deemed to involve one or
more purchases or sales of securities or property between affiliated
persons.
    6. Section 17(a)(1) of the 1940 Act, in relevant part, prohibits
any affiliated person of a registered investment company, or any
affiliated person of such person, acting as principal, from knowingly
selling any security or other property to that company. Section
17(a)(2) of the 1940 Act generally prohibits the persons described
above, acting as principals, from knowingly purchasing any security or
other property from the registered investment company.
    7. The Section 17 Applicants state that the proposed transactions
may involve a transfer of portfolio securities by the Existing
Portfolios to the Separate Accounts. Immediately thereafter, the
Separate Accounts would purchase shares of the Replacement Portfolios
with the portfolio securities received from the Existing Portfolios.
Accordingly, the Section 17 Applicants provide that to the extent
Commonwealth and the Existing Portfolios, and Commonwealth and the
Replacement Portfolios, are deemed to be affiliated persons of one
another under Section 2(a)(3) or Section 2(a)(9) of the 1940 Act, it is
conceivable that this aspect of the proposed Substitutions could be
viewed as being prohibited by Section 17(a). Accordingly, the Section
17 Applicants have determined to seek relief from Section 17(a).
    8. The Section 17 Applicants submit that the terms of the proposed
in-kind purchases of shares of the Replacement Portfolios by the
Separate Accounts, including the consideration to be paid and received,
as described in the application, are reasonable and fair and do not
involve overreaching on the part of any person concerned. The Section
17 Applicants submit that the terms of the proposed in-kind
transactions, including the considered to be paid to each Existing
Portfolio and received by each Replacement Portfolio involved, are
reasonable, fair and do not involve overreaching principally because
the transactions will conform with all but one of the conditions
enumerated in Rule 17a-7 under the 1940 Act. The proposed transactions
will take place at relative net asset value in conformity with the
requirements of Section 22(c) of the 1940 Act and Rule 22c-1 thereunder
without the imposition of any transfer or similar charges by the
Section 26 Applicants. The Substitutions will be effected without
change in the amount or value of any Contract held by the affected
Contract owners. The Substitutions will in no way alter the tax
treatment of affected Contract owners in connection with their
Contracts, and no tax liability will arise for Contract owners as a
result of the Substitutions. The fees and charges under the Contracts
will not increase because of the Substitutions. Even though the
Separate Accounts, Commonwealth and the Trust may not rely on Rule 17a-
7, the Section 17 Applicants believe that the rule's conditions outline
the type of safeguards that result in transactions that are fair and
reasonable to registered investment company participants and preclude
overreaching in connection with an investment company by its affiliated
persons.
    9. The Section 17 Applicants also submit that the proposed in-kind
purchases by the Separate Accounts are consistent with the policies of
the Trust and the Replacement Portfolios, as provided in the Trust's
registration statement and reports filed under the 1940 Act. Finally,
the Section 17 Applicants submit that the proposed Substitutions are
consistent with the general purposes of the 1940 Act.

Applicants' Conditions

    The Section 26 Applicants, and Global Atlantic as applicable, agree
that any order granting the requested relief will be subject to the
following conditions:
    1. The Substitutions will not be effected unless Commonwealth
determines that: (i) The Contracts allow the substitution of shares of
registered open-end investment companies in the manner contemplated by
the application; (ii) the Substitutions can be consummated as described
in the application under applicable insurance laws; and (iii) any
regulatory requirements in each jurisdiction where the Contracts are
qualified for sale have been complied with to the extent necessary to
complete the Substitutions.
    2. After the Substitution Date, Global Atlantic will not change a
sub-adviser, add a new sub-adviser, or otherwise rely on the Manager of
Managers Order (as defined in the application), or any replacement
order from the Commission, with respect to any Replacement Portfolio
without first obtaining shareholder approval of the change in sub-
adviser, the new sub-adviser, or the Replacement Portfolio's ability to
rely on the Manager of Managers Order, or any replacement order from
the Commission.
    3. Commonwealth or an affiliate thereof (other than the Trust) will
pay all expenses and transaction costs of the Substitutions, including
legal and accounting expenses, any applicable brokerage expenses and
other fees and expenses. No fees or charges will be assessed to the
affected Contract owners to effect the Substitutions. The proposed
Substitutions will not cause the Contract fees and charges currently
being paid by Contract owners to be greater after the proposed
Substitution than before the proposed Substitution.
    4. The Substitutions will be effected at the relative net asset
values of the respective shares of the Replacement Portfolios in
conformity with Section 22(c) of the 1940 Act and Rule 22c-1 thereunder
without the imposition of any transfer or similar charges by the
Section 26 Applicants. The Substitutions will be effected without
change in the amount or value of any Contracts held by affected
Contract owners.
    5. The Substitutions will in no way alter the tax treatment of
affected Contract owners in connection with their Contracts, and no tax
liability will arise for Contract owners as a result of the
Substitutions.
    6. The obligations of the Section 26 Applicants, and the rights of
the affected Contract owners, under the Contracts of affected Contract
owners will not be altered in any way.
    7. Affected Contract owners will be permitted to make at least one
transfer of Contract value from the subaccount investing in the
Existing Portfolio (before the Substitution Date) or the Replacement
Portfolio (after the Substitution Date) to any other available
investment option under the Contract without charge for a period
beginning at least 30 days before the Substitution Date through at
least 30 days following the Substitution Date. Except as described in
any market timing/short-term trading provisions of the relevant
prospectus, the Section 26 Applicants will not exercise any rights
reserved under the Contracts to impose restrictions on transfers
between the subaccounts under the Contracts, including limitations on
the future number of transfers, for a period beginning at least 30 days
before the Substitution Date through at least 30 days following the
Substitution Date.
    8. All affected Contract owners will be notified, at least 30 days
before the Substitution Date about: (i) The intended Substitution of
Existing Portfolios with the Replacement Portfolios; (ii) the intended
Substitution Date; and (iii) information with respect to transfers as
set forth in Condition 7

above. In addition, the Section 26 Applicants will also deliver to
affected Contract owners, at least thirty days before the Substitution
Date, a prospectus for each applicable Replacement Portfolio.
    9. The Section 26 Applicants will deliver to each affected Contract
owner within five business days of the Substitution Date a written
confirmation which will include: (i) A confirmation that the
Substitutions were carried out as previously notified; (ii) a
restatement of the information set forth in the Pre-Substitution
Notice; and (iii) values of the Contract owner's positions in the
Existing Portfolio before the Substitution and the Replacement
Portfolio after the Substitution.
    10. For a period of two years following the Substitution Date, for
Contract owners who were Contract owners as of the Substitution Date,
Commonwealth or an affiliate thereof (other than the Trust) will
reimburse, on the last business day of each fiscal quarter, the
Contract owners whose subaccounts invest in the applicable Replacement
Portfolio to the extent that the Replacement Portfolio's net annual
operating expenses (taking into account fee waivers and expense
reimbursements) for such period exceeds, on an annualized basis, the
net annual operating expenses of the Existing Portfolio for the most
recent fiscal year preceding the date of the application. In addition,
the Section 26 Applicants will not increase the Contract fees and
charges that would otherwise be assessed under the terms of the
Contracts for a period of at least two years following the Substitution
Date.

    For the Commission, by the Division of Investment Management,
under delegated authority.
Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2017-08904 Filed 5-2-17; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 86, Number 196 (Thursday, October 14, 2021)]
[Notices]
[Page 57187]
[FR Doc No: 2021-22432]

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

DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4619-DR; Docket ID FEMA-2021-0001]

California; Major Disaster and Related Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: This is a notice of the Presidential declaration of a major
disaster for the State of California (FEMA-4619-DR), dated September
12, 2021, and related determinations.

DATES: The declaration was issued September 12, 2021.

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

SUPPLEMENTARY INFORMATION: Notice is hereby given that, in a letter
dated September 12, 2021, the President issued a major disaster
declaration under the authority of the Robert T. Stafford Disaster
Relief and Emergency Assistance Act, 42 U.S.C. 5121 et seq. (the
``Stafford Act''), as follows:

    I have determined that the damage in certain areas of the State
of California resulting from the Caldor Fire beginning on August 14,
2021, and continuing, is of sufficient severity and magnitude to
warrant a major disaster declaration under the Robert T. Stafford
Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121 et seq.
(the ``Stafford Act''). Therefore, I declare that such a major
disaster exists in the State of California.
    In order to provide Federal assistance, you are hereby
authorized to allocate from funds available for these purposes such
amounts as you find necessary for Federal disaster assistance and
administrative expenses.
    You are authorized to provide Public Assistance in the
designated areas and Hazard Mitigation throughout the State.
Consistent with the requirement that Federal assistance be
supplemental, any Federal funds provided under the Stafford Act for
Public Assistance and Hazard Mitigation will be limited to 75
percent of the total eligible costs.
    Further, you are authorized to make changes to this declaration
for the approved assistance to the extent allowable under the
Stafford Act.

    The Federal Emergency Management Agency (FEMA) hereby gives notice
that pursuant to the authority vested in the Administrator, under
Executive Order 12148, as amended, Andrew Grant, of FEMA is appointed
to act as the Federal Coordinating Officer for this major disaster.
    The following areas of the State of California have been designated
as adversely affected by this major disaster:

    El Dorado County for Public Assistance.
    All areas within the State of California are eligible for
assistance under the Hazard Mitigation Grant Program.

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

Deanne Criswell,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2021-22432 Filed 10-13-21; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register: March 24, 2010 (Volume 75, Number 56)]
[Notices]
[Page 14216]
[DOCID:fr24mr10-126]

=======================================================================
-----------------------------------------------------------------------

SECURITIES AND EXCHANGE COMMISSION

Submission for OMB Review; Comment Request

Upon Written Request, Copies Available From: U.S. Securities and
Exchange Commission, Office of Investor Education and Advocacy,
Washington, DC 20549-0213.
Extension:
    Rule 17g-4; SEC File No. 270-566; OMB Control No. 3235-0627.

    Notice is hereby given that, pursuant to the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (``Commission'') has submitted to the Office of Management
and Budget a request for approval of extension of the previously
approved collection provided for in Rule 17g-4 (17 CFR 240.17g-4) under
the Securities Exchange Act of 1934 (15 U.S.C. 78a et seq.) (``Exchange
Act'').
    The Rating Agency Act added a new Section 15E, ``Registration of
Nationally Recognized Statistical Rating Organizations,'' \1\ to the
Exchange Act. Rule 17g-4 requires that a Nationally Recognized
Statistical Rating Organization (``NRSRO'') has written policies and
procedures to prevent the misuse of material nonpublic information
including: procedures designed to prevent the inappropriate
dissemination of material nonpublic information obtained in connection
with the performance of credit rating services; procedures designed to
prevent a person associated with the rating organization from trading
on material nonpublic information; and procedures designed to prevent
the inappropriate dissemination of a pending credit rating.\2\
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78o-7.
    \2\ See Rule 17g-4. Release No. 34-55231 (Feb. 2, 2007), 72 FR
6378 (Feb. 9, 2007); and Release No. 34-55857 (June 5, 2007), 72 FR
33564 (June 18, 2007).
---------------------------------------------------------------------------

    It is anticipated that 30 credit rating agencies will register with
the Commission as NRSROs under Section 15E of the Exchange Act. The
Commission estimates that it will take approximately 50 hours for an
NRSRO to establish procedures in conformance with Rule 17g-4 for a
total one-time burden for the 30 credit rating agencies the Commission
estimates will register as NRSROs of 1,500 hours.\3\
---------------------------------------------------------------------------

    \3\ 50 hours x 30 NRSROs = 1,500 hours.
---------------------------------------------------------------------------

    An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information unless it displays a
currently valid control number.
    Comments should be directed to: (i) Desk Officer for the Securities
and Exchange Commission Office of Information and Regulatory Affairs,
Office of Management and Budget, Room 10102, New Executive Office
Building, Washington, DC 20503 or by sending an e-mail to: Shagufta_
<EMAIL_ADDRESS>and (ii) Charles Boucher, Director/Chief Information
Officer, Securities and Exchange Commission, c/o Shirley Martinson,
6432 General Green Way, Alexandria, Virginia 22312 or send an e-mail to
<EMAIL_ADDRESS>Comments must be submitted to OMB within 30 days
of this notice.

    Dated: March 17, 2010.
Florence E. Harmon,
Deputy Secretary.
[FR Doc. 2010-6504 Filed 3-23-10; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 77, Number 226 (Friday, November 23, 2012)]
[Notices]
[Pages 70167-70168]
[FR Doc No: 2012-28430]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-D-1120]

Draft Guidance for Industry on Vaginal Microbicides: Development
for the Prevention of Human Immunodeficiency Virus Infection;
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance for industry entitled ``Vaginal
Microbicides: Development for the Prevention of HIV Infection.'' The
purpose of this guidance is to assist sponsors in all phases of
development of vaginal microbicides for the prevention of human
immunodeficiency virus (HIV) infection. The guidance outlines the types
of nonclinical studies and clinical trials recommended throughout the
drug development process to support approval of vaginal microbicides.

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

ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 2201, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Charu Mullick, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 6365, Silver Spring, MD 20993-0002, 301-
796-1500.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Vaginal Microbicides: Development for the Prevention of HIV
Infection.'' This guidance addresses nonclinical development, early
phases of clinical development, phase 3 trial considerations, and
safety considerations in vaginal microbicide development, including
safety considerations in adolescent and pregnant populations. The
guidance also provides some information on approaches for developing
combination microbicide products such as drug-drug combinations, drug-
device combinations containing a microbicide, or combination products
containing a microbicide that are intended for multiple indications.
With the recent approval of oral emtricitabine/tenofovir for HIV pre-
exposure prophylaxis (PrEP), the effect of oral PrEP on microbicide
trial designs is an emerging topic. The guidance discusses this issue;
however, it should be noted the pertinent sections may be revised as
FDA takes into consideration evolving opinions in the prevention field
as well as public comments on this topic.
    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 developing
vaginal microbicides for preventing HIV transmission. It does not
create or confer any rights for or on any person and does not operate
to bind FDA or the public. An alternative approach may be used if such
approach satisfies the requirements of the applicable statutes and
regulations.

II. The Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of
information that are subject to review by the Office of Management and
Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520). The collections of information in 21 CFR part 312 have been
approved under OMB control number 0910-0014, and the collections of
information referred to in the guidance for clinical trial sponsors
entitled ``Establishment and Operation of Clinical Trial Data
Monitoring Committees'' have been approved under OMB control number
0910-0581.

III. Comments

    Interested persons may submit either written comments regarding the
draft guidance to the Division of Dockets

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

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: November 19, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-28430 Filed 11-21-12; 8:45 am]
BILLING CODE 4160-01-P