[Federal Register Volume 84, Number 194 (Monday, October 7, 2019)]
[Notices]
[Pages 53482-53487]
[FR Doc No: 2019-21811]

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SECURITIES AND EXCHANGE COMMISSION

[Investment Company Act Release No. 33654; File No. 812-15033]

Mutual of America Life Insurance Company, et al.

October 2, 2019.
Agency: Securities and Exchange Commission (``Commission'').

Action: Notice.

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    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 ``Act'') and an order of exemption
pursuant to section 17(b) of the Act from section 17(a) of the Act.

Applicants: Mutual of America Life Insurance Company (``Mutual of
America''), Wilton Reassurance Life Company of New York (``Wilton,''
and together with Mutual of America, the ``Companies''), Mutual of
America Separate Account No. 2, Mutual of America Separate Account No.
3, American Separate Account No. 2, and American Separate Account No. 3
(the ``Separate Accounts,'' and together with the Companies, the
``Section 26 Applicants''); and Mutual of America Variable Insurance
Portfolios, Inc. (``Investment Corporation II'') and Mutual of America
Capital Management LLC (the ``Adviser,'' and collectively with
Investment Corporation II and 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 Act, approving the substitution of shares
issued by certain investment portfolios (the ``Existing Portfolios'')
of Mutual of America Investment Corporation (``Investment Corporation
I'') for shares of certain investment portfolios of the Investment
Corporation II (the ``Replacement Portfolios''), held by the Separate
Accounts to support certain variable annuity insurance contracts
(``Non-Qualified Annuity Contracts'') and variable life insurance
contracts (the ``Life Insurance Contracts'').\1\ The Section 17
Applicants seek an order pursuant to section 17(b) of the Act exempting
them from section 17(a) of the Act to the extent necessary to permit
them to engage in certain in-kind transactions.
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    \1\ The variable annuity contracts that are issued in connection
with retirement plans or individual retirement annuities under the
Code (other than the individual retirement annuities issued by
American Separate Account No. 2) are referred to herein as the
``Qualified Annuity Contracts.'' The Non-Qualified Annuity
Contracts, the Life Insurance Contracts, and the Qualified Annuity
Contracts are collectively referred to herein as the ``Contracts.''

Filing Dates: The application was filed on May 15, 2019 and amended on
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August 20, 2019 and September 27, 2019.

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 October 28, 2019 and should be accompanied
by proof of service on the Applicants in the form of an affidavit or,
for lawyers, a certificate of service. Pursuant to rule 0-5 under the
Act, hearing requests should state the nature of the writer's interest,
any facts bearing upon the desirability of a hearing on the matter, the
reason for the request, and the issues contested. Persons who wish to
be notified of a hearing may request notification by writing to the
Commission's Secretary.

ADDRESSES: Secretary, Securities and Exchange Commission, 100 F Street
NE, Washington, DC 20549-1090. Applicants: Mutual of America Life
Insurance Company, 320 Park Avenue, New York, New York 10022.

FOR FURTHER INFORMATION CONTACT: Hae-Sung Lee, Senior Counsel, at (202)
551-7345, or Trace W. Rakestraw, 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 website by searching for the file number, or for an
Applicant using the Company name box, at http://www.sec.gov.search/search.htm, or by calling<PHONE_NUMBER>.

Applicants' Representations

    1. Mutual of America is a mutual life insurance company organized
under the laws of the state of New York and is authorized to transact
its business in 50 states and the District of Columbia.
    2. Wilton is a life insurance company organized under New York law
and is authorized to transact the business of life insurance, including
annuities, in all 50 states, the Virgin Islands, and the District of
Columbia. Wilton was a wholly-owned subsidiary of a holding company
that was, in turn, 100% owned by Mutual of America. Mutual of America
sold the holding company that owned Wilton but retained full authority
and responsibility to take all actions in regard to American Separate
Account No. 2 and American Separate Account No. 3, under an agreement
with the holding company, and assumptively reinsured the variable
contracts offered through those accounts.
    3. Each Separate Account meets the definition of ``separate
account,'' as defined in section 2(a)(37) of the Act and rule 0-1(e)
thereunder. The Separate Accounts are registered with the Commission
under the Act as unit investment trusts. The assets of the Separate
Accounts support the Contracts and interests in the Separate Accounts
offered through such Contracts. The Companies are the legal owners of
the assets in their respective Separate Accounts. The Separate Accounts
are segmented into subaccounts, and each subaccount invests in an
underlying registered open-end management investment company or series
thereof.
    4. The Contracts are individual and group flexible premium variable
annuity and variable life insurance contracts. Each Contract is
registered under the Securities Act of 1933, as amended (the ``1933
Act'') on Form N-4 or Form N-6 (or, in the case of the variable life
insurance contract supported by American Separate Account No. 3, on
Form S-6). Each Contract has particular fees, charges, and investment
options, as described in the Contracts' respective prospectuses.
    5. As set forth under each Contract, as well as in the prospectus
for each Contract, the Companies reserve the right to substitute shares
of the underlying fund for shares of another underlying fund. The
substitutions will be performed only for the Non-Qualified Annuity
Contracts and the Life Insurance Contracts. The substitutions will not
affect the Qualified Annuity Contracts.
    6. The Companies, on their own behalf and on behalf of their
Separate Accounts, propose to exercise their contractual rights to
substitute underlying funds currently available under the Contracts for
different underlying funds (``Substitutions'' or each, a
``Substitution''), as shown in the table below:

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        Substitution No.             Existing portfolio                     Replacement portfolio
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1...............................  Equity Index Fund.......  Equity Index Portfolio.
2...............................  All America Fund........  All America Portfolio.
3...............................  Small Cap Value Fund....  Small Cap Value Portfolio.
4...............................  Small Cap Growth Fund...  Small Cap Growth Portfolio.
5...............................  Small Cap Equity Index    Small Cap Equity Index Portfolio.
                                   Fund.
6...............................  Mid Cap Value Fund......  Mid Cap Value Portfolio.
7...............................  Mid-Cap Equity Index      Mid-Cap Equity Index Portfolio.
                                   Fund.
8...............................  Composite Fund..........  Moderate Allocation Portfolio.
9...............................  International Fund......  International Portfolio.
10..............................  Money Market Fund.......  Money Market Portfolio.
11..............................  Mid-Term Bond Fund......  Mid-Term Bond Portfolio.
12..............................  Bond Fund...............  Bond Portfolio.
13..............................  Retirement Income Fund..  Retirement Income Portfolio.
14..............................  2010 Retirement Fund....  2010 Retirement Portfolio.
15..............................  2015 Retirement Fund....  2015 Retirement Portfolio.
16..............................  2020 Retirement Fund....  2020 Retirement Portfolio.
17..............................  2025 Retirement Fund....  2025 Retirement Portfolio.
18..............................  2030 Retirement Fund....  2030 Retirement Portfolio.
19..............................  2035 Retirement Fund....  2035 Retirement Portfolio.
20..............................  2040 Retirement Fund....  2040 Retirement Portfolio.
21..............................  2045 Retirement Fund....  2045 Retirement Portfolio.
22..............................  2050 Retirement Fund....  2050 Retirement Portfolio.
23..............................  2055 Retirement Fund....  2055 Retirement Portfolio.
24..............................  2060 Retirement Fund....  2060 Retirement Portfolio.
25..............................  Conservative Allocation   Conservative Allocation Portfolio.
                                   Fund.
26..............................  Moderate Allocation Fund  Moderate Allocation Portfolio.
27..............................  Aggressive Allocation     Aggressive Allocation Portfolio.
                                   Fund.
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    7. The Existing Portfolios are series of Investment Corporation I,
a Maryland corporation registered as an open-end management investment
company under the Act (File No. 811-05084) and whose shares are
registered under the 1933 Act (File No. 033-06486). Investment
Corporation I issues separate classes (or series) of shares, each of
which represents a separate portfolio of investments. There are
currently 27 series of Investment Corporation I; they are the Existing
Portfolios. Investment Corporation I intends to begin offering shares
of its series directly to the general public through the retail market.
    8. The Replacement Portfolios are series of Investment Corporation
II, a Maryland corporation. On June 13, 2019, Investment Corporation II
filed a new registration statement on Form N-1A to register as an open-
end management investment company under the Act (File No. 811-23449)
and to register shares of the Replacement Portfolios under the 1933 Act
(File No. 333-232095). There will be 26 series of

Investment Corporation II; they are the Replacement Portfolios.
Investment Corporation II was formed for the purpose of performing the
Substitutions. However, new series of Investment Corporation II may be
established in the future, and the series of Investment Corporation II
may be made available as investment allocation options under variable
insurance contracts of the Companies other than the Non-Qualified
Annuity Contracts and the Life Insurance Contracts.
    9. The Adviser serves as the investment adviser for the Existing
Portfolios and the Replacement Portfolios. The Adviser is a Delaware
limited liability company that is registered as an investment adviser
under the Investment Advisers Act of 1940. A sub-adviser has not been
engaged to manage any of the Portfolios.
    10. Applicants state that the primary purpose of the Substitutions
is to preserve the favorable tax treatment of the Non-Qualified Annuity
Contracts and the Life Insurance Contracts that are currently supported
by the Existing Portfolios. With exception of Substitution No. 8, each
Existing Portfolio and its corresponding Replacement Portfolio have
identical investment objectives, strategies, and risks and
substantially identical fee structures (with different expense ratios
due to differences in net assets). With respect to Substitution No. 8,
the Existing Portfolio and its corresponding Replacement Portfolio have
substantially similar objectives, strategies, and risks, and the
Replacement Portfolio has a lower expense ratio. The Portfolios are
advised by the same Adviser and share a common board of directors. As
such, the Substitutions will permit owners of the Non-Qualified Annuity
Contracts (``Non-Qualified Annuity Contract Owners'') and owners of the
Life Insurance Contracts (``Life Insurance Contract Owners'') to
maintain the favorable tax treatment of their Non-Qualified Annuity and
Life Insurance Contracts and continue their investments in
substantially identical underlying funds (or a substantially similar
underlying fund with respect to Substitution No. 8).
    11. In order to preserve that favorable tax treatment, Section 26
Applicants propose to reallocate contract values attributable to the
Non-Qualified Annuity and Life Insurance Contracts from the Existing
Portfolios to the Replacement Portfolios. Applicants represent that the
Substitutions will preserve the favorable tax treatment of the Non-
Qualified Annuity and Life Insurance Contracts because the Replacement
Portfolios will be offered only under variable annuity and life
insurance contracts. The Replacement Portfolios will not be sold
directly to the general public through the retail market.
    12. Mutual of America will cause the Adviser to enter into a
written contract with Investment Corporation II whereby, for a period
of two years following the date of substitution for each Substitution
(the ``Substitution Date''), the Adviser will, at least as frequently
as the last business day of each fiscal quarter, reimburse the expenses
of the Replacement Portfolio to the extent that the net annual
operating expenses of the Replacement Portfolio (after taking into
account any other fee waivers or expense reimbursements) for such
period exceed, 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 (the ``Expense Caps''). Any
amounts waived or reimbursed by the Adviser will not be subject to
recoupment rights. Any Expense Cap that applies to a Replacement
Portfolio as a condition of this application is separate and apart from
any other contractual expense reimbursement agreement between
Investment Corporation II and the Adviser. To the extent that an
Expense Cap caps a Replacement Portfolio's net annual operating
expenses at a lower percentage of net assets than any other contractual
expense reimbursement agreement between Investment Corporation II and
the Adviser, such other contractual expense reimbursement agreement
will have no practical impact on the Replacement Portfolio's net annual
operating expenses due to the operation of the Expense Cap. In
addition, for each Substitution, the Section 26 Applicants will not
increase the Contract fees and charges that would otherwise be assessed
under the terms of the Contracts for the Non-Qualified Annuity and Life
Insurance Contract Owners for a period of at least two years following
the Substitution Date.
    13. Applicants represent that as of the Substitution Date, the
Separate Accounts will redeem shares of the applicable Existing
Portfolios for cash and/or in-kind. Redemption requests and purchase
orders will be placed simultaneously so that the Non-Qualified Annuity
and Life Insurance 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 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 Non-Qualified Annuity and Life
Insurance Contracts.\2\
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    \2\ The Section 26 Applicants note that, because the
Substitutions will occur at relative net asset value, and the fees
and charges under the Non-Qualified Annuity and Life Insurance
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. 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 each Existing Portfolio and
Replacement Portfolio, 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.
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    15. Non-Qualified Annuity and Life Insurance Contract Owners will
not incur any fees or charges as a result of the Substitutions. The
obligations of the Section 26 Applicants, and the rights of the Non-
Qualified Annuity and Life Insurance Contract Owners, under the
Contracts will not be altered in any way. The Companies and/or their
affiliates (other than Investment Corporation II) 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 paid by the Non-Qualified
Annuity and Life Insurance Contract Owners to effect the Substitutions.
The Substitutions will not cause the Contract fees and charges
currently being paid by Non-Qualified Annuity and Life Insurance
Contract Owners to be greater after any Substitution than before the
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. From the date of the Pre-Substitution Notice (defined below)
through 30 days following the Substitution Date, Non-Qualified Annuity
and Life Insurance 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 a Substitution Date, values

under Non-Qualified Annuity and Life Insurance Contracts attributable
to investments in the applicable Existing Portfolio will be transferred
to the corresponding Replacement Portfolio without charge and without
being subject to any transfer limitations. Moreover, for each
Substitution, except with respect to frequent trading restrictions
described in the Contracts' prospectuses, the Companies will not
exercise any rights reserved under their policies to impose
restrictions on transfers between the subaccounts for a period
beginning at least 30 days before the Substitution Date through at
least 30 days following the Substitution Date.
    17. For each Substitution, at least 30 days prior to the
Substitution Date, Non-Qualified Annuity and Life Insurance Contract
Owners will be notified via prospectus supplements (i) that the Section
26 Applicants received or expect to receive Commission approval of the
Substitution and (ii) of the anticipated Substitution Date (the ``Pre-
Substitution Notice''). Pre-Substitution Notices sent to Non-Qualified
Annuity and Life Insurance Contract Owners (including a subset of
contract owners that own inactive contracts (``Inactive Contract
Owners'')) will be filed with the Commission pursuant to rule 497(e)
under the 1933 Act. The Pre-Substitution Notice will also advise Non-
Qualified Annuity and Life Insurance Contract Owners of their pre- and
post-Substitution rights. For each Substitution, the Section 26
Applicants will also deliver to affected Non-Qualified Annuity and Life
Insurance Contract Owners (including Inactive Contract Owners), at
least 30 days before the Substitution Date, a prospectus for the
Replacement Portfolio.
    18. In addition, within five business days after the Substitution
Date, Non-Qualified Annuity and Life Insurance Contract Owners
(including Inactive Contract Owners) whose assets were allocated to the
Replacement Portfolio as part of the Substitution will be sent a
written notice (a ``Confirmation'') informing them that the
Substitution was carried out as previously notified. The Confirmation
will also restate the information set forth in the Pre-Substitution
Notice. The Confirmation will also reflect the values of the Non-
Qualified Annuity or Life Insurance 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 Act approving the Substitutions.
Section 26(c) 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 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 Act was amended to include this provision.
Applicants state that they are seeking the Substitutions to preserve
the favorable tax treatment of the Non-Qualified Annuity Contracts and
the Life Insurance Contracts. A key feature of annuity and life
insurance contracts is the deferral of federal income taxes on the
accumulated earnings within such contracts if fund shares supporting
such contracts are not offered directly to the general public. The
Existing Portfolios are presently sold in a manner that facilitates the
deferral of federal income taxes on the accumulated earnings under the
Non-Qualified Annuity and Life Insurance Contracts. However, in an
effort to expand the markets to which the Existing Portfolios are
offered, Investment Corporation I intends to begin offering shares of
the Existing Portfolios directly to the general public through the
retail market. While this initiative will generally benefit the
Existing Portfolios, and will not affect the tax treatment of the
Qualified Annuity Contracts, it would result in the Non-Qualified
Annuity and Life Insurance Contracts no longer receiving tax deferral
unless the Substitutions are performed.
    3. Companies have 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 Substitutions are not
of the type that section 26 was designed to prevent because they will
not result in costly forced redemptions, nor will they affect any other
aspects of the Contracts. In the current situation, Contract owners are
contractually provided investment discretion during the accumulation
phase of the Contracts to allocate and reallocate their Contract values
among the investment options available under the Contracts.
Accordingly, after the Substitutions, each Non-Qualified Annuity and
Life Insurance Contract Owner may exercise his or her own judgment as
to the most appropriate investment alternative available under the
Contract. Moreover, for each Substitution, the Section 26 Applicants
will offer Non-Qualified Annuity and Life Insurance Contract Owners the
opportunity to transfer amounts out of the affected subaccounts which,
as with all transfers under the Contracts, will be without any cost or
other penalty (other than those necessary to implement policies and
procedures designed to detect and deter disruptive transfers) for a
period beginning on the date of the Pre-Substitution Notice (which
supplement will be delivered to the Non-Qualified Annuity and Life
Insurance Contract Owners at least 30 days before the Substitution
Date) and ending no earlier than 30 days after the Substitution Date.
The Substitutions, therefore, will not result in the type of forced
redemption that section 26(c) was designed to prevent.
    5. The 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. Specifically, the
Substitutions will not affect the type of benefits offered by the
Companies under the Contracts, or numerous other rights and privileges
associated with the Contracts.
    6. 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 Substitutions. The Section 17 Applicants state that because the
Substitutions may be effected, in whole or in part, by means of in-kind
redemptions and purchases, the Substitutions may be deemed to involve
one or more purchases or sales of securities or property between
affiliated persons.
    7. Section 17(a)(1) of the 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 Act
generally prohibits the persons described above, acting as principals,
from knowingly purchasing any security or other property from the
registered investment company.
    8. 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 that the Companies, the Separate
Accounts, the Adviser, Investment Corporation II, or the Replacement
Portfolios are deemed to be affiliated persons of one another under
section 2(a)(3) or section 2(a)(9) of the Act, it is conceivable that
this aspect of the 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).
    9. 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 also submit that the terms of the proposed in-kind
transactions, including the consideration to be paid by 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 Act.
    10. The proposed transactions will take place at relative net asset
value in conformity with the requirements of section 22(c) of the 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 Non-Qualified
Annuity Contract or any Life Insurance Contract. The Substitutions will
in no way alter the tax treatment of Non-Qualified Annuity and Life
Insurance Contract Owners in connection with their Contracts, and no
tax liability will arise for Non-Qualified Annuity and Life Insurance
Contract Owners as a result of the Substitutions. The fees and charges
under the Non-Qualified Annuity and Life Insurance Contracts will not
increase because of the Substitutions. Even though the Company, the
Separate Accounts, the Adviser, Investment Corporation II, and the
Replacement Portfolios 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.
    11. The Section 17 Applicants also submit that the proposed in-kind
purchases by the Separate Accounts are consistent with the investment
policies and restrictions of the Section 17 Applicants and the
Replacement Portfolio. Finally, the Section 17 Applicants submit that
the Substitutions are consistent with the general purposes of the Act.

Applicants' Conditions

    Applicants agree that any order granting the requested relief will
be subject to the following conditions:
    1. The Substitutions will not be effected unless the Companies
determine 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. The Companies or an affiliate thereof (other than Investment
Corporation II) 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 paid by Non-Qualified Annuity and Life Insurance Contract Owners to
effect the Substitutions. The Substitutions will not cause the Contract
fees and charges currently being paid by Non-Qualified Annuity and Life
Insurance Contract Owners to be greater after the Substitution than
before the Substitution.
    3. 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 Act and rule 22c-1 thereunder
without the imposition of any transfer or similar charges by the
Applicants. The Substitutions will be effected without change in the
amount or value of any Non-Qualified Annuity Contract or Life Insurance
Contract.
    4. The Substitutions will in no way alter the tax treatment of Non-
Qualified Annuity and Life Insurance Contract Owners in connection with
their Contracts, and no tax liability will arise for Non-Qualified
Annuity and Life Insurance Contract Owners as a result of the
Substitutions.
    5. The obligations of the Section 26 Applicants, and the rights of
the Non-Qualified Annuity and Life Insurance Contract Owners, under the
Non-Qualified Annuity and Life Insurance Contracts will not be altered
in any way.
    6. For each Substitution, Non-Qualified Annuity and Life Insurance
Contract Owners will be permitted to transfer 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 subaccount without charge for a period beginning at
least 30 days before the Substitution Date through at least 30 days
following the Substitution Date. Except with respect to any frequent
trading restrictions described in the relevant prospectus, the
Applicants will not exercise any rights reserved under the Contracts to
impose restrictions on transfers between the subaccounts, 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.
    7. For each Substitution, all Non-Qualified Annuity and Life
Insurance Contract Owners will be notified via the Pre-Substitution
Notice, at least 30 days before the Substitution Date, about: (i) The
intended Substitution of the Existing Portfolio with the Replacement
Portfolio; (ii) the intended Substitution Date; and (iii) information
with respect to transfers as set forth in Condition 6 above. In
addition, for each Substitution, the Section 26 Applicants will also
deliver to Non-Qualified Annuity and Life Insurance Contract Owners, at
least 30 days before the Substitution Date, a prospectus for the
applicable Replacement Portfolio.
    8. For each Substitution, the Section 26 Applicants will deliver to
each Non-Qualified Annuity and Life Insurance Contract Owner within
five business days after the Substitution Date, a written confirmation
which will include: (i) A confirmation that the Substitution was
carried out as previously notified; (ii) a restatement of the
information set forth in the Pre-Substitution Notice; and (iii) values
of the Non-Qualified Annuity and Life Insurance Contract Owner's
positions in the Existing Portfolio before the Substitution and the
Replacement Portfolio after the Substitution.
    9. Mutual of America will cause the Adviser, as the investment
adviser of the Replacement Portfolios, to enter into a written contract
with Investment Corporation II whereby, for a period of two years
following the Substitution Date for each Substitution, the Adviser
will, at least as frequently as the last business day of each fiscal
quarter,

reimburse the expenses of the Replacement Portfolio to the extent that
the net annual operating expenses of the Replacement Portfolio (i.e.,
after taking into account any other fee waivers or expense
reimbursements) for such period exceed, 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. Any amounts waived
or reimbursed by the Adviser will not be subject to recoupment rights.
In addition, for each Substitution, the Section 26 Applicants will not
increase the Contract fees and charges that would otherwise be assessed
under the terms of the Contracts for the Non-Qualified Annuity and Life
Insurance Contract Owners for a period of at least two years following
the Substitution Date.

    For the Commission, by the Division of Investment Management,
under delegated authority.
Jill M. Peterson,
Assistant Secretary.
[FR Doc. 2019-21811 Filed 10-4-19; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 78, Number 218 (Tuesday, November 12, 2013)]
[Notices]
[Pages 67365-67367]
[FR Doc No: 2013-26856]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-1361]

Determination That Adderall (Amphetamine Aspartate; Amphetamine
Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate)
Tablet and 13 Other Drug Products Were Not Withdrawn From Sale for
Reasons of Safety or Effectiveness

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) has determined that the
drug products listed in this document were not withdrawn from sale for
reasons of safety or effectiveness. This determination means that FDA
will not begin procedures to withdraw approval of abbreviated new drug
applications (ANDAs) that refer to these drug products, and it will
allow FDA to continue to approve ANDAs that refer to the products as
long as they meet relevant legal and regulatory requirements.

FOR FURTHER INFORMATION CONTACT: Amy Hopkins, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6207, Silver Spring, MD 20993-0002, 301-
796-5418.

SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price
Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417)
(the 1984 amendments), which authorized the approval of duplicate
versions of drug products approved under an ANDA procedure. ANDA
sponsors must, with certain exceptions, show that the drug for which
they are seeking approval contains the same active ingredient in the
same strength and dosage form as the ``listed drug,'' which is a
version of the drug that was previously approved. Sponsors of ANDAs do
not have to repeat the extensive clinical testing otherwise necessary
to gain approval of a new drug application (NDA).
    The 1984 amendments include what is now section 505(j)(7) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which
requires FDA to publish a list of all approved drugs. FDA publishes
this list as part of the ``Approved Drug Products With Therapeutic
Equivalence Evaluations,'' which is generally known as the ``Orange
Book.'' Under FDA regulations, a drug is removed from the list if the
Agency withdraws or suspends approval of the drug's NDA or ANDA for
reasons of safety or effectiveness, or if FDA determines that the
listed drug was withdrawn from sale for reasons of safety or
effectiveness (21 CFR 314.162).
    Under Sec.  314.161(a) (21 CFR 314.161(a)), the Agency must
determine whether a listed drug was withdrawn from sale for reasons of
safety or effectiveness: (1) Before an ANDA that refers to that listed
drug may be approved, (2) whenever a listed drug is voluntarily
withdrawn from sale and ANDAs that refer to the listed drug have been
approved, and (3) when a person petitions for such a determination
under 21 CFR 10.25(a) and 10.30. Section 314.161(d) provides that if
FDA determines that a listed drug was withdrawn from sale for safety or
effectiveness reasons, the Agency will initiate proceedings that could
result in the withdrawal of approval of the ANDAs that refer to the
listed drug.
    FDA has become aware that the drug products listed in the table in
this document are no longer being marketed.

------------------------------------------------------------------------
       Application No.                Drug                Applicant
------------------------------------------------------------------------
NDA 011522..................  ADDERALL              Teva Womens Health
                               (amphetamine          Inc., 41 Moores
                               aspartate;            Rd., P.O. Box 4011,
                               amphetamine           Frazer, PA 19355.
                               sulfate;
                               dextroamphetamine
                               saccharate;
                               dextroamphetamine
                               sulfate) Tablet;
                               Oral, 5 milligrams
                               (mg), 7.5 mg, 10
                               mg, 12.5 mg, 15 mg,
                               20 mg, 30 mg.
NDA 011601..................  KENALOG               Apothecon
                               (triamcinolone        Pharmaceuticals,
                               acetonide) Cream;     General Offices,
                               Topical, 0.025%,      P.O. Box 4500,
                               0.1%.                 Princeton, NJ 08543-
                                                     4500.
NDA 013601..................  MUCOMYST              Do.
                               (acetylcysteine)
                               Solution;
                               Inhalation, Oral,
                               10%, 20%.
NDA 018531..................  NITROGLYCERIN         Hospira Inc., 275
                               (nitroglycerin)       North Field Dr.,
                               Injectable;           Bldg. H2, Lake
                               Injection, 5mg/       Forest, IL 60045-
                               milliliter (mL).      5046.
NDA 018726..................  WESTCORT              Ranbaxy Inc., 600
                               (hydrocortisone       College Rd., East
                               valerate) Ointment;   Princeton, NJ
                               Topical, 0.2%.        08540.
NDA 018830..................  TAMBOCOR (flecainide  Medicis
                               acetate) Tablet;      Pharmaceutical
                               Oral, 50 mg, 100      Corp., 7720 North
                               mg, 150 mg.           Dobson Rd.,
                                                     Scottsdale, AZ
                                                     85256.
NDA 020336..................  DYNACIRC CR           GlaxoSmithKline
                               (isradipine)          LLC., 2711
                               Tablet; Extended      Centerville Rd.,
                               Release, Oral, 5      Ste. 400,
                               mg, 10 mg.            Wilmington, DE
                                                     19808.
NDA 020518..................  RETROVIR              ViiV Healthcare, 5
                               (zidovudine)          Moore Dr., Research
                               Tablet; Oral, 300     Triangle Park, NC
                               mg.                   27709.
NDA 021745..................  RYZOLT (tramadol      Purdue Pharma
                               HCl) Tablet;          Products LP, 1
                               Extended Release,     Stamford Forum,
                               Oral, 100 mg, 200     Stamford, CT 06901.
                               mg, 300 mg.
NDA 022021..................  ALTACE (ramipril)     Pfizer Inc., 501 5th
                               Tablet; Oral, 1.25    St., Bristol, TN
                               mg, 2.5 mg, 5 mg,     37620.
                               10 mg.
NDA 050808..................  SOLODYN (minocycline  Medicis
                               HCl) Tablet;          Pharmaceutical
                               Extended Release;     Corp., 7720 North
                               Equivalent to (EQ)    Dobson Rd.,
                               45 mg Base, EQ 90     Scottsdale, AZ
                               mg Base, EQ 135 mg    85256.
                               Base.
ANDA 081295.................  ESTRACE (estradiol)   Bristol Myers
                               Tablet; Oral, 0.5     Squibb, P.O. Box
                               mg.                   4000, Princeton, NJ
                                                     08543.
ANDA 084499.................  ESTRACE (estradiol)   Do.
                               Tablet; Oral, 1 mg.
ANDA 084500.................  ESTRACE (estradiol)   Do.
                               Tablet; Oral, 2 mg.
------------------------------------------------------------------------

    FDA has reviewed its records and, under Sec.  314.161, has
determined that the drug products listed in this document were not
withdrawn from sale for reasons of safety or effectiveness.
Accordingly, the Agency will continue to list the drug products listed
in this document in the ``Discontinued Drug Product List'' section of
the Orange Book. The ``Discontinued Drug Product List'' identifies,
among other items, drug products that have been discontinued from
marketing for reasons other than safety or effectiveness.
    Approved ANDAs that refer to the NDAs and ANDAs listed in this
document are unaffected by the discontinued marketing of the products
subject to those NDAs and ANDAs. Additional ANDAs that refer to these
products may also be approved by the Agency if they comply with
relevant legal and regulatory requirements. If FDA determines that
labeling for these drug products should be revised to meet current
standards, the Agency will advise ANDA applicants to submit such
labeling.

    Dated: November 5, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-26856 Filed 11-8-13; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 80, Number 3 (Tuesday, January 6, 2015)]
[Notices]
[Pages 593-594]
[FR Doc No: 2014-30891]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-73957; File No. SR-MIAX-2014-068]

Self-Regulatory Organizations; Miami International Securities
Exchange LLC; Notice of Filing and Immediate Effectiveness of a
Proposed Rule Change To Amend Its Fee Schedule

December 30, 2014.
    Pursuant to the provisions of Section 19(b)(1) of the Securities
Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice
is hereby given that on December 19, 2014, Miami International
Securities Exchange LLC (``MIAX'' or ``Exchange'') filed with the
Securities and Exchange Commission (``Commission'') a proposed rule
change as described in Items I, II, and III below, which Items have
been prepared by the Exchange. The Commission is publishing this notice
to solicit comments on the proposed rule change from interested
persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange is filing a proposal to modify the Trading Permit Fee
for EEMs.
    The text of the proposed rule change is available on the Exchange's
Web site at http://www.miaxoptions.com/filter/wotitle/rule_filing, at
MIAX's principal office, and at the Commission's Public Reference Room.

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

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

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

1. Purpose
    The Exchange proposes to modify its Monthly Trading Permit fee to
increase the monthly Trading Permit fee that applies to Electronic
Exchange Members (``EEMs''). Specifically, the Exchange proposes to
increase the monthly Trading Permit fee that applies to EEMs to $1,500,
from the current level of $1,000.
    The Exchange issues Trading Permits that confer the ability to
transact on the Exchange.\3\ The Exchange assesses monthly fees for
Trading Permits depending upon the category of Member that is issued a
particular trading permit.\4\ EEMs are assessed a monthly fee of $1,000
for a Trading Permit. All Market Makers, whether they are a Registered
Market Makers (``RMMs''), Lead Market Makers (``LMMs''), or Primary
Lead Market Makers (``PLMMs''), are assessed $4,000.00 per month for a
Trading Permit for an assignment in up to 100 option classes, $5,500.00
per month for a Trading Permit for an assignment in up to 250 option
classes, or $7,000.00 per month for a Trading Permit for an assignment
in all option classes listed on the Exchange.
---------------------------------------------------------------------------

    \3\ There is no limit on the number of Trading Permits that may
be issued by the Exchange; however the Exchange has the authority to
limit or decrease the number of Trading Permits it has determined to
issue provided it complies with the provisions set forth in Rule
200(a) and Section 6(c)(4) of the Exchange Act. See 15 U.S.C.
78(f)(c)(4). For a complete description of MIAX Trading Permits, see
MIAX Rule 200.
    \4\ The monthly Trading Permit Fee is in addition to the one-
time application fee for MIAX Membership. The Exchange charges a
one-time application fee based upon the applicant's status as either
an Electronic Exchange Member (``EEM'') or as a Market Maker.
Applicants for MIAX Membership as an EEM are assessed a one-time
Application Fee of $2,500.00. Applicants for MIAX Membership as a
Market Maker are assessed a one-time Application Fee of $3,000.00.
The difference in the fee charged to EEMs and Market Makers reflects
the additional review and processing effort needed for Market Maker
applications.
---------------------------------------------------------------------------

    The Exchange proposes to increase the monthly Trading Permit fee
that applies to EEMs to $1,500, in order to increase the Exchange's
non-transaction fee revenues. The Exchange notes that the proposed
monthly Trading Permit fees are generally lower than monthly trading
permit fees in place at CBOE and the NASDAQ OMX PHLX LLC (``PHLX'').
The $1,500 monthly Trading Permit fee to be assessed to EEMs is lower
than the CBOE's monthly electronic access trading permit fee ($1,600)
and the PHLX's monthly permit fee for members ($2,150).
    Members receiving Trading Permits during the month will be assessed
Trading Permit Fees according to the above schedule, except that the
calculation of the Trading Permit fee for the first month in which the
Trading Permit is issued will be pro-rated based on the number of
trading days occurring

after the date on which the Trading Permit was in effect during that
first month divided by the total number of trading days in such month
multiplied by the monthly rate.
    The Exchange proposes to implement the Trading Permit fees
beginning January 1, 2015.
2. Statutory Basis
    The Exchange believes that its proposal to amend its fee schedule
is consistent with Section 6(b) of the Act \5\ in general, and furthers
the objectives of Section 6(b)(4) of the Act \6\ in particular, in that
it is an equitable allocation of reasonable fees and other charges
among Exchange members.
---------------------------------------------------------------------------

    \5\ 15 U.S.C. 78f(b).
    \6\ 15 U.S.C. 78f(b)(4).
---------------------------------------------------------------------------

    The Exchange believes that the proposed Trading Permit fee is
reasonable, equitable and not unfairly discriminatory. The Exchange
notes that the Trading Permit fees are lower than comparable fees at
other exchanges as described in the Purpose section above. As such, the
proposal is reasonably designed because it will incent market
participants to register as EEMs on the Exchange in a manner that
enables the Exchange to improve its overall competitiveness and
strengthen its market quality for all market participants. The proposed
fee is fair and equitable and not unreasonably discriminatory because
the Trading Permit fee applies equally to all Members who choose to
register as an EEM. All similarly situated EEMs will be subject to the
same Trading Permit fee, and access to the Exchange is offered on terms
that are not unfairly discriminatory.

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

    The Exchange does not believe that the proposed rule change will
impose any burden on competition not necessary or appropriate in
furtherance of the purposes of the Act. The Exchange believes that the
proposal increases both intermarket and intramarket competition by
marginally increasing Trading Permit fees for EEMs on the Exchange in a
manner that still remains lower than comparable fees on other
exchanges. The Exchange notes that it operates in a highly competitive
market in which market participants can readily favor competing venues
if they deem fee levels at a particular venue to be excessive. In such
an environment, the Exchange must continually adjust its fees to remain
competitive with other exchanges and to attract order flow to the
Exchange. The Exchange believes that the proposal reflects this
competitive environment because it increases the Exchange's fees in a
manner that continues to encourage market participants to register as
EEMs on the Exchange, to provide liquidity, and to attract order flow.
To the extent that this purpose is achieved, all the Exchange's market
participants should benefit from the improved market liquidity.

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

    Written comments were neither solicited nor received.

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A)(ii) of the Act.\7\ At any time within 60 days of the filing
of the proposed rule change, the Commission summarily may temporarily
suspend such rule change if it appears to the Commission that such
action is necessary or appropriate in the public interest, for the
protection of investors, or otherwise in furtherance of the purposes of
the Act. If the Commission takes such action, the Commission shall
institute proceedings to determine whether the proposed rule should be
approved or disapproved.
---------------------------------------------------------------------------

    \7\ 15 U.S.C. 78s(b)(3)(A)(ii).
---------------------------------------------------------------------------

IV. Solicitation of Comments

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

Electronic comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please
include File Number SR-MIAX-2014-068 on the subject line.

Paper comments

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

All submissions should refer to File Number SR-MIAX-2014-068. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549, on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of the filing also will be available
for inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-MIAX-2014-068 and should be
submitted on or before January 27, 2015.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\8\
---------------------------------------------------------------------------

    \8\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Brent J. Fields,
Secretary.
[FR Doc. 2014-30891 Filed 1-5-15; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 82, Number 235 (Friday, December 8, 2017)]
[Notices]
[Pages 57991-57993]
[FR Doc No: 2017-26442]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-D-6294]

Changes to Existing Medical Software Policies Resulting From
Section 3060 of the 21st Century Cures Act; Draft Guidance for Industry
and Food and Drug Administration Staff; 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 the draft guidance entitled ``Changes to Existing
Medical Software Policies Resulting from Section 3060 of the 21st
Century Cures Act.'' This draft guidance provides clarity on FDA's
current thinking regarding changes made by the 21st Century Cures Act
(Cures Act) to the definition of a medical device and the resulting
effect on guidances related to medical device software. This draft
guidance is not final nor is it in effect at this time.

DATES: Submit either electronic or written comments on the draft
guidance by February 6, 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-2017-D-6294 for ``Changes to Existing Medical Software Policies
Resulting from Section 3060 of the 21st Century Cures Act; Draft
Guidance for Industry and Food and Drug Administration Staff;
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)).
    An electronic copy of the guidance document is available for
download from the internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance. Submit written
requests for a single hard copy of the draft guidance document entitled
``Changes to Existing Medical Software Policies Resulting from Section
3060 of the 21st Century Cures Act'' to the Office of the Center
Director, Guidance and Policy Development, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-0002, or the Office
of Communication, Outreach, and Development, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your request.

FOR FURTHER INFORMATION CONTACT: Bakul Patel, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5458, Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
or Stephen Ripley, Center for Biologics Evaluation and Research, Food
and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA has long regulated software that meets the definition of a
device. Section 3060(a) of the Cures Act, enacted on December 13, 2016
(Pub. L. 114-255), amended the Federal Food, Drug, and Cosmetic Act
(the FD&C Act) to exclude certain medical software functions from the
definition of device under section 201(h) of the FD&C Act (21 U.S.C.
321(h)). Under sections 520(o)(1)(A)-(D) of the FD&C Act (21 U.S.C.
360j(o)(1)(A)-(D)), as added by the Cures Act, certain medical software
functions are not medical devices, including software functions that
are intended (1) for administrative support of a health care facility,
(2) for maintaining or encouraging a healthy lifestyle, (3) to serve as
electronic patient records, or (4) for transferring, storing,
converting formats, or displaying data.
    This draft guidance explains the effect of the medical software
provisions in the Cures Act on preexisting FDA policy, including policy
on mobile medical applications; medical device

data systems used for the electronic transfer, storage, display, or
conversion of medical device data; medical image storage devices, used
to store or retrieve medical images electronically; medical image
communications devices, used to transfer medical image data
electronically between medical devices; software that automates
laboratory workflow; and low-risk general wellness products. FDA
intends to provide clarification of its interpretation of section
520(o)(1)(E) of the FD&C Act, which is for software functions intended
to provide decision support for the diagnosis, treatment, prevention,
cure, or mitigation of disease or other conditions (often referred to
as clinical decision support software) in a separate guidance document.
Section 520(o)(2) of the FD&C Act describes the regulation of a product
with multiple functions, including at least one device function and at
least one software function that is not a device. FDA also intends to
provide recommendations on the regulation of such products with
multifunctionality in a separate guidance document.

II. Significance of Guidance

    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 ``Changes to
Existing Medical Software Policies Resulting from Section 3060 of the
21st Century Cures Act.'' It does not establish any rights for any
person and is not binding on FDA or the public. You can use an
alternative approach if it satisfies the requirements of the applicable
statutes and regulations. This guidance is not subject to Executive
Order 12866.

III. Electronic Access

    Persons interested in obtaining a copy of the draft guidance may do
so by downloading an electronic copy from the Internet. A search
capability for all Center for Devices and Radiological Health guidance
documents is available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance
documents are also available at https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm or https://www.regulations.gov. Persons unable to download
an electronic copy of ``Changes to Existing Medical Software Policies
Resulting from Section 3060 of the 21st Century Cures Act'' may send an
email request to [email protected] to receive an electronic
copy of the document. Please use the document number 17030 to identify
the guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR part 820 have been approved under
OMB control number 0910-0073; the collections of information in 21 CFR
part 807, subpart E, have been approved under OMB control number 0910-
0120; the collections of information in 21 CFR part 803 have been
approved under OMB control number 0910-0437; and the collections of
information in 21 CFR parts 801 and 809 have been approved under OMB
control number 0910-0485.

    Dated: December 4, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-26442 Filed 12-7-17; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 82, Number 220 (Thursday, November 16, 2017)]
[Notices]
[Page 53495]
[FR Doc No: 2017-24791]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket Nos. EL18-27-000, QF86-968-015]

EF Oxnard LLC, Notice of Request for Waiver

    Take notice that on November 7, 2017, pursuant to section
292.205(c) of the Federal Energy Regulatory Commission's (Commission)
implementing the Public Utility Regulatory Policies Act of 1978, as
amended 18 CFR 292.205(c) (2017), EF Oxnard LLC (EF Oxnard) submitted a
request for limited waiver of the efficiency standard set forth in
section 292.205(a)(2) for the topping-cycle cogeneration facility owned
and operated by EF Oxnard, as more fully explained in its request.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date.
Anyone filing a motion to intervene or protest must serve a copy of
that document on the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov. Persons unable to file electronically should submit an
original and 5 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive email
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please email
[email protected], or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5:00 p.m. Eastern time on November 28, 2017.

    Dated: November 8, 2017.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2017-24791 Filed 11-15-17; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 77, Number 31 (Wednesday, February 15, 2012)]
[Proposed Rules]
[Pages 8757-8758]
[FR Doc No: 2012-3589]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 280 and 281

[EPA-HQ-UST-2011-0301; FRL-9631-6]
RIN 2050-AG46

Revising Underground Storage Tank Regulations--Revisions to
Existing Requirements and New Requirements for Secondary Containment
and Operator Training

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule; extension of comment period.

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

SUMMARY: EPA is extending the public comment period for the proposed
changes to the 1988 underground storage tank (UST) technical, financial
responsibility, and state program approval regulations published in the
Federal Register on November 18, 2011 (76 FR 71708) (FRL-9485-5). These
changes establish federal requirements that are similar to key portions
of the Energy Policy Act of 2005; they also update certain 1988 UST
regulations. Proposed changes include: Adding secondary containment
requirements for new and replaced tanks and piping; adding operator
training requirements; adding periodic operation and maintenance
requirements for UST systems; removing certain deferrals; adding new
release prevention and detection technologies; updating codes of
practice; making editorial and technical corrections; and updating
state program approval requirements to incorporate these new changes.
These changes will likely protect human health and the environment by
increasing the number of prevented UST releases and quickly detecting
them, if they occur. This document extends the comment period for 60
days, from February 16, 2012 until April 16, 2012.

DATES: Comments must be received on or before April 16, 2012.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-
UST-2011-0301, by one of the following methods:
     www.regulations.gov: Follow the on-line instructions for
submitting comments.
     Email<EMAIL_ADDRESS>     Mail: EPA Docket Center (EPA/DC), Docket ID No. EPA-HQ-
OPA-2009-0880, Mail Code 2822T, 1200 Pennsylvania Ave. NW., Washington,
DC 20460. In addition, please mail a copy of your comments on the
information collection provisions to the Office of Information and
Regulatory Affairs, Office of Management and Budget (OMB), Attn: Desk
Officer for EPA, 725 17th St. NW., Washington, DC 20503.
     Hand Delivery: EPA Docket Center (EPA/DC), EPA West, Room
3334, 1301 Constitution Ave. NW., Washington DC 20460. Attention Docket
ID No. EPA-HQ-UST-2011-0301. Such deliveries are only accepted during
the Docket's normal hours of operation, and special arrangements should
be made for deliveries of boxed information.
    Instructions: Direct your comments to Docket ID No. EPA-HQ-UST-
2011-0301. EPA's policy is that all comments received will be included
in the public docket without change and may be made available online at
www.regulations.gov, including any personal information provided,
unless the comment includes information claimed to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Do not submit information that you consider to
be CBI or otherwise protected through www.regulations.gov or email. The
www.regulations.gov Web site is an ``anonymous access'' system, which
means EPA will not know your identity or contact information unless you
provide it in the body of your comment. If you send an email comment
directly to EPA without going through www.regulations.gov your email
address will be automatically captured and included as part of the
comment that is placed in the public docket and made available on the
Internet. If you submit an electronic comment, EPA recommends that you
include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses. For additional
information about EPA's public docket, visit the EPA Docket Center
homepage at http://www.epa.gov/epahome/dockets.htm.
    Docket: All documents in the docket are listed in the
www.regulations.gov index. Although listed in the index, some
information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, will be publicly available only in hard copy.
Publicly available docket materials are available either electronically
in www.regulations.gov or in hard copy at the Docket, EPA/DC, EPA West,
Room 3334, 1301 Constitution Ave. NW., Washington, DC. The Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is<PHONE_NUMBER>, and the telephone number for the EPA
Docket Center (EPA/DC) is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Elizabeth McDermott, OSWER/OUST
(5401P), Environmental Protection Agency, 1200 Pennsylvania Avenue NW.,
Washington, DC 20460; telephone number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: This document extends the public comment
period established in the Federal Register on November 18, 2011. In
that document EPA proposed changes that establish federal requirements
that are similar to key portions of the Energy Policy Act of 2005; they
also update certain 1988 UST regulations. Several potential commenters
requested an extension to the comment period. EPA is hereby extending
the comment period, which was set to end on February 16, 2012, to April
16, 2012. To submit comments, please follow the detailed instructions
as provided under ADDRESSES. If you have questions, consult the
individual listed under FOR FURTHER INFORMATION CONTACT.

List of Subjects

40 CFR Part 280

    Environmental protection, Administrative practice and procedures,
Confidential business information, Groundwater, Hazardous materials,
Petroleum, Reporting and recordkeeping requirements, Underground
storage

tanks, Water pollution control, Water supply.

40 CFR Part 281

    Environmental protection, Administrative practice and procedures,
Hazardous materials, Petroleum, State program approval, Underground
storage tanks.

    Dated: February 8, 2012.
Carolyn Hoskinson,
Director, Office of Underground Storage Tanks, Office of Solid Waste
and Emergency Response.
[FR Doc. 2012-3589 Filed 2-14-12; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 76, Number 245 (Wednesday, December 21, 2011)]
[Rules and Regulations]
[Page 79064]
[FR Doc No: 2011-32591]

=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510 and 522

[Docket No. FDA-2011-N-0003]

New Animal Drugs; Change of Sponsor; Zinc Gluconate

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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

SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect a change of sponsor for a new animal drug
application (NADA) for zinc gluconate injectable solution from
Technology Transfer, Inc., to Ark Sciences, Inc.

DATES: This rule is effective December 21, 2011.

FOR FURTHER INFORMATION CONTACT: Steven D. Vaughn, Center for
Veterinary Medicine (HFV-100), Food and Drug Administration, 7520
Standish Pl., Rockville, MD 20855,<PHONE_NUMBER>, email:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Technology Transfer, Inc., 33 East Broadway,
suite 190, Columbia, MO 65203 has informed FDA that it has transferred
ownership of, and all rights and interest in, NADA 141-217 for
NEUTERSOL (zinc gluconate) Injectable Solution to Ark Sciences, Inc.,
1101 East 33rd St., suite B304, Baltimore, MD 21218. Accordingly, the
Agency is amending the regulations in 21 CFR 522.2690 to reflect the
transfer of ownership.
    Following this change of sponsorship, Technology Transfer, Inc., is
no longer the sponsor of an approved application. Accordingly, Sec.
510.600 (21 CFR 510.600) is being amended to remove the entries for
this firm.
    In addition, Ark Sciences, Inc., is not currently listed in the
animal drug regulations as a sponsor of an approved application.
Accordingly, Sec.  510.600 is being amended to add entries for this
sponsor.
    This rule does not meet the definition of ``rule'' in 5 U.S.C.
804(3)(A) because it is a rule of ``particular applicability.''
Therefore, it is not subject to the congressional review requirements
in 5 U.S.C. 801-808.

List of Subjects

21 CFR Part 510

    Administrative practice and procedure, Animal drugs, Labeling,
Reporting and recordkeeping requirements.

21 CFR Part 522

    Animal drugs.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs and
redelegated to the Center for Veterinary Medicine, 21 CFR parts 510 and
522 are amended as follows:

PART 510--NEW ANIMAL DRUGS

0
1. The authority citation for 21 CFR part 510 continues to read as
follows:

    Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.

0
2. In Sec.  510.600, in the table in paragraph (c)(1), remove the entry
for ``Technology Transfer, Inc.''; alphabetically add a new entry for
``Ark Sciences, Inc.''; and in the table in paragraph (c)(2), remove
the entry for ``067647''; and in numerical sequence add a new entry for
``076175'' to read as follows:

Sec.  510.600  Names, addresses, and drug labeler codes of sponsors of
approved applications.

* * * * *
    (c) * * *
    (1) * * *

------------------------------------------------------------------------
                                                                 Drug
                   Firm name and address                       labeler
                                                                 code
------------------------------------------------------------------------

                                * * * * *
Ark Sciences, Inc., 1101 East 33rd St., suite B304,               076175
 Baltimore, MD 21218.......................................

                                * * * * *
------------------------------------------------------------------------

    (2) * * *

------------------------------------------------------------------------
         Drug labeler code                  Firm name and address
------------------------------------------------------------------------

                                * * * * *
076175............................  Ark Sciences, Inc., 1101 East 33rd
                                     St., suite B304, Baltimore, MD
                                     21218.

                                * * * * *
------------------------------------------------------------------------

PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

0
3. The authority citation for 21 CFR part 522 continues to read as
follows:

    Authority: 21 U.S.C. 360b.

Sec.  522.2690  [Amended]

0
4. In paragraph (b) of Sec.  522.2690, remove ``067647'' and in its
place add ``076175''.

    Dated: December 8, 2011.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. 2011-32591 Filed 12-20-11; 8:45 am]
BILLING CODE 4160-01-P


Instructions for Completing OMB Form 83 I Please answer all questions and have a Senior Official or a designee sign the form. These instructions should be used in conjunction with 5 CFR 1320, which provides information on coverage, definitions, and other matters of procedure and interpretation under the Paperwork Reduction Act of 1995.

Once completed, submit one copy of your OMB 83 I form, with an original signature, to the OEI Collection Strategies Division ( CSD) as part of your ICR package.

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If you have any problems or questions, please call your ICR Desk Officer. They are: Rick Westlund ( Team Leader), 260 2745 OPPTS Monica Lewis, 260 4522 OSWER Phil Silverstein, 260 2728 Air ICR renewals Delores Evans, 260 1625 Air rules and rule amendments Lynn Johnson, 260 2964 Water, OP, ORD, OARM, OECA ( not airrelated OA, Regions ( not media specific) PAPERWORK REDUCTION ACT SUBMISSION Please read the instructions before completing this form. For additional forms or assistance in completing this form, contact your agency's Paperwork Clearance Officer. Send two copies of this form, the collection instrument to be reviewed, the Supporting Statement and any additional documentation to: Office of Information and Regulatory Affairs, Office of Management and Budget, Docket Library, Room 10102, 725 17th Street NW Washington, DC 20503.

1. Agency/ Subagency originating request EPA/ Office of Water/ Office of Science and Technology 2. OMB control number b. G None a 2040 0202 __ __ __ __

3. Type of information collection ( check one) a. G New collection b. G Revision of a currently approved collection c. XExtension of a currently approved collection d. G Reinstatement, without change, of a previously approved collection for which approval has expired e. G Reinstatement, with change, of a previously approved collection for which approval has expired f. G Existing collection in use without an OMB control number 4. Type of review requested ( check one) a. X Regular b. G Emergency  Approval requested by: / / c. G Delegated 5. Small entities Will this information collection have a significant economic impact on a substantial number of small entities? G Yes X No For b f, note item A2 of Supporting Statement Instructions 6. Requested expiration date a. X Three years from approval date b. G Other Specify: / /___

7. Title Milestones Plan for the Bleached Papergrade Kraft and Soda Subcategory of the Pulp, Paper, and Paperboard Point Source Category 8. Agency form number( s) ( If applicable) ICR#: 1877.02 9. Keywords Milestones Plan, VATIP, Voluntary Advanced Technology Incentives Program, Cluster Rule, direct discharging mills, bleached papergrade kraft, soda, " mill of the future"

10. Abstract The information to be collected is a Milestones Plan, which is required as part of a new Voluntary Advanced Technology Incentives Program ( VATIP) established under the Pulp, Paper, and Paperboard Effluent Limitations Guidelines and Standards ( 40 CFR Part 430) portion of the Cluster Rule promulgated on April 15, 1998. Only direct discharging bleached papergrade kraft and soda mills are eligible to participate in the VATIP. Furthermore, the Milestones Plan is required only of those mills that voluntarily choose to enroll in the incentives program. The VATIP ( 40 CFR 430.24( b)) is intended to encourage existing and new direct discharging mills to move beyond today's baseline BAT and NSPS technologies.

11. Affected public ( Mark primary with " P" and all others that apply with " X") a. Individuals or households d. Farms b. PBusiness or other for profit e. X Federal Government c. Not for profit institutions f. X State, Local or Tribal Government 12. Obligation to respond ( Mark primary with " P" and all others that apply with " X") a. G Voluntary b. G Required to obtain or retain benefits c. X Mandatory 13. Annual reporting and recordkeeping hour burden a. Number of respondents 29 b. Total annual responses 29 1. Percentage of these responses collected electronically 0 % c. Total hours requested 1,418 d. Current OMB inventory 1,302 e. Difference 116 f. Explanation of difference 1. Program Change 0 2. Adjustment 116 14. Annual reporting and recordkeeping cost burden ( in thousands of dollars)

a. Total annualized capital/ startup costs $ 0 b. Total annual costs ( O& M) $ 0 c. Total annualized cost requested $ 0 d. Current OMB inventory $ 78 e. Difference $ 78 f. Explanation of difference 1. Program change $ 0 2. Adjustment $ 78 15. Purpose of information collection ( Mark Primary With " P" and all others that apply with " X") a. __ Application for benefits e. __ Program planning or management b. __ Program evaluation f. __ Research c. __ General purpose statistics g. X_ Regulatory or compliance d. __ Audit 16. Frequency of recordkeeping or reporting ( check all that apply) a. X Recordkeeping b. Q Third party disclosure c. x Reporting 1. Q On occasion 2. Q Weekly 3. Q Monthly 4. Q Quarterly 5. Q Semi annually 6. X Annually 7. Q Biannually 8. Q Other ( describe) 17. Statistical methods Does this information collection employ statistical methods?

Q Yes X No 18. Agency contact ( person who can best answer questions regarding the content of this submission) Name: M. Ahmar Siddiqui Phone: ( 202) 260 1826 OMB 83 I 10/ 95 19. Certification for Paperwork Reduction Act Submissions On behalf of this Federal agency, 1 certify that the collection of information encompassed by this request complies with' 5 CFR 1320.9.

NOTE: The text of 5 CFR 1320.9, and the related provisions of 5 CFR 1320.8( b)( 3), appear at the end of the instructions. The certification is to be made with reference to those regulatory provisions as set forth in the instructions.

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

( a) It is necessary for the proper performance of agency functions;

( b) It avoids unnecessary duplication;

( c) It reduces burden on small entities;

( d) It uses plain, coherent, and unambiguous terminology that is understandable to respondents;

( e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

( f) It indicates the retention periods for recordkeeping requirements;

( g) It informs respondents of the information called for under 5 CFR 1320.8( b)( 3): ( I) Why the information is being collected' ( ii) Use of information; ( iii) Burden estimate; ( iv) Nature of response ( voluntary, required for a benefit, or mandatory); ( v) Nature and extent of confidentiality; and ( vi) Need to display currently valid OMB control number;

( h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected ( see note in Item 19 of the instructions);

( I) It uses effective and efficient statistical survey methodology; and ( j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item below and explain the reason in Item 18 of the Supporting Statement.

Signature of Program Official Date Signature of Senior Official or designee Oscar Morales, Director Collection Strategies Division Office of Information Collection Office of Environmental Information Date OMB 83 I 10/ 95 Certification Requirement for Paperwork Reduction Act Submissions 5 CFR 1320.9 reads " As part of the agency submission to OMB of a proposed collection of information, the agency ( through the head of the agency, the Senior Official or their designee) shall certify ( and provide a record supporting such certification) that the proposed collection of information

"( a) is necessary for the proper performance of the functions of the agency, including that the information to be collected will have practical utility;

"( b) is not unnecessarily duplicative of information otherwise reasonably accessible to the agency;

"( c) reduces to the extent practicable and appropriate the burden on persons who shall provide information to or for the agency, including with respect to small entities, as defined in the Regulatory Flexibility Act 5 U. S. C. § 601( 6)), the use of such techniques as:

"( 1) establishing differing compliance or reporting requirements or timetables that take into account the resources available to those who are to respond; "( 2) the clarification, consolidation, or simplification of compliance and reporting requirements; or collection of information , or any part thereof; "( 3) an exemption from coverage of the collection of information, or any part thereof;

"( d) is written using plain, coherent, and unambiguous terminology and is understandable to those who are to respond;

"( e) is to be implemented in ways consistent and compatible, to the maximum extent practicable, with the existing reporting and recordkeeping practices of those who are to respond;

"( f) indicates for each recordkeeping requirement the length of time persons are required to maintain the records specified;

"( g) informs potential respondents of the information called for under § 1320.8( b)( 3); [ see below]

"( h) has been developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected, including the processing of the information in a manner which shall enhance, where appropriate, the utility of the information to agencies and the public;

"( I) uses effective and efficient statistical survey methodology appropriate to the purpose for which the information is to be collected; and "( j) to the maximum extent practicable, uses appropriate information technology to reduce burden and improve data quality, agency efficiency and responsiveness to the public."

NOTE: 5 CFR 1320.8( b)( 3) requires that each collection of information:

"( 3) informs and provides reasonable notice to the potential persons to whom the collection of information is addressed of: "( I) the reasons the information is planned to be and/ or has been used to further the proper performance of the functions of the agency; "( ii) the way such information is planned to be and/ or has been used to further the proper performance of the functions of the agency; "( iii) an estimate, to the extent practicable, of the average burden of the collection ( together with a request that the public direct to the agency any comments concerning the accuracy of this burden estimate and any suggestions for reducing this burden); "( iv) whether responses to the collection of information are voluntary, required to obtain or retain a benefit ( citing authority), or mandatory ( citing authority); "( v) the nature and extent of confidentiality to be provided, if any ( citing authority); and "( vi) the fact that any agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number."

OMB 83 I ( Instructions) 10/ 95