[Federal Register: January 13, 2009 (Volume 74, Number 8)]
[Notices]
[Page 1730-1734]
[DOCID:fr13ja09-91]

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SECURITIES AND EXCHANGE COMMISSION

[Investment Company Act Release No. 28578; 812-13239]

SunAmerica Focused Alpha Growth Fund, Inc., et al.; Notice of
Application

January 6, 2009.
AGENCY: Securities and Exchange Commission (``Commission'').

ACTION: Notice of application under section 6(c) of the Investment
Company Act of 1940 (``Act'') for an exemption from section 19(b) of
the Act and rule 19b-1 under the Act.

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Summary of Application:  Applicants request an order to permit certain
closed-end investment companies to make periodic distributions of long-
term capital gains with respect to their outstanding common stock as
frequently as twelve times each year, and as frequently as
distributions are specified by or in accordance with the terms of any
outstanding preferred stock that such investment companies may issue.

Applicants:  SunAmerica Focused Alpha Growth Fund, Inc. (``FGF''),
SunAmerica Focused Alpha Large-Cap Fund, Inc. (``FGI'') and AIG
SunAmerica Asset Management Corp. (the ``Adviser'').

Filing Dates:  October 17, 2005 and September 2, 2008.

Hearing or Notification of Hearing:  An order granting the application
will be issued unless the Commission orders a hearing. Interested
persons may request a hearing by writing to the Commission's Secretary
and serving applicants with a copy of the request, personally or by
mail. Hearing requests should be received by the Commission by 5:30
p.m. on February 2, 2009, and should be accompanied by proof of service
on applicants, in the form of an affidavit or, for lawyers, a
certificate of service. Hearing requests should state the nature of the
writer's interest, the reason for the request, and the issues
contested. Persons who wish to be notified of a hearing may request
notification by writing to the Commission's Secretary.

ADDRESSES: Secretary, Securities and Exchange Commission, 100 F Street,
NE., Washington, DC 20549-1090; Applicants, c/o AIG SunAmerica Asset
Management Corp., Harborside Financial Center, 3200 Plaza 5, Jersey
City, NJ 07311-4992, Attention: Gregory N. Bressler.

FOR FURTHER INFORMATION CONTACT: Wendy Friedlander, Senior Counsel, at
(202) 551-6837, or James M. Curtis, Branch Chief, at<PHONE_NUMBER>
(Division of Investment Management, Office of Chief Counsel).

SUPPLEMENTARY INFORMATION: The following is a summary of the
application. The complete application may be obtained for a fee at the
Commission's Public Reference Room, 100 F Street, NE., Washington, DC
20549-1520 (telephone<PHONE_NUMBER>).

Applicants' Representations

    1. FGF and FGI are registered closed-end management investment
companies organized as Maryland corporations, and each has capital
growth as its investment objective.\1\ The common stock of FGF and FGI
are listed on the New York Stock Exchange. FGF and FGI have not issued
preferred stock. Applicants believe that the stockholders of FGF and
FGI are generally conservative, dividend-sensitive investors who desire
current income periodically and may favor a fixed distribution policy.
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    \1\ Applicants request that any order issued granting the relief
requested in the application also apply to any closed-end investment
company (``fund'') that in the future: (a) Is advised by the Adviser
(including any successor in interest) or by any entity controlling,
controlled by, or under common control (within the meaning of
section 2(a)(9) of the Act) with the Adviser; and (b) complies with
the terms and conditions of the requested order. A successor in
interest is limited to entities that result from a reorganization
into another jurisdiction or a change in the type of business
organization.
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    2. The Adviser is a Delaware corporation and is registered as an
investment adviser under the Investment Advisers Act of 1940. The
Adviser is the investment adviser for FGF and FGI and provides
investment advice and management services to other mutual funds and
accounts. The Adviser is a wholly-owned subsidiary of American
International Group, Inc.
    3. Applicants represent that prior to May 30, 2007, the Board of
Directors (the ``Boards'') of FGF and FGI, including a majority of the
members of each of the Boards who are not ``interested persons'' of
each fund (the ``Independent Directors'') as defined in section
2(a)(19) of the Act, requested information, and the Adviser provided,
such information as was reasonably necessary for the Boards to
determine whether FGF or FGI should adopt a proposed distribution
policy.
    4. Applicants represent that at a meeting on May 30, 2007, the
Directors reviewed the information regarding the purpose and terms of a
proposed distribution policy, the likely effects of such policy on each
fund's long-term total return (in relation to market price and net
asset value (``NAV'') per common share) and the relationship between
such fund's distribution rate on its common stock under the policy and
the fund's total return on NAV per share. Applicants state that the
Independent Directors of each fund also considered what conflicts of
interest the Adviser and the affiliated persons of the Adviser and each
fund might have with respect to the adoption or implementation of such
policy.
    5. Applicants state that at another meeting on August 27, 2007, the
Boards of FGF and FGI, including the Independent directors, approved a
revised distribution policy with respect to its fund's common stock
(``Plan'') and determined that such Plan is consistent with such fund's
investment objectives and in the best interest of such fund's common
stockholders.
    4. Applicants state that the purpose of each of the proposed Plans
would be to permit each fund to distribute over the course of each year
periodic and level distributions that would be independent of the
fund's performance during any particular period but that would be
expected to correlate with the fund's performance over time. Applicants
explain that each distribution would be at the stated rate then in
effect, except for extraordinary distributions and potential increases
or decreases in the final dividend periods in light of the fund's
performance for the entire calendar year and to enable the fund to
comply with the distribution requirements of Subchapter M of the
Internal Revenue Code of 1986 (the ``Code'') for the calendar year.
Applicants state that the Boards of the funds will periodically review
the amount of potential distributions in light of the investment
experience of each fund, and may modify or terminate the fund's Plan at
any time.
    5. Applicants state that at the August 27, 2007 meeting, the Boards
of FGF and FGI each also adopted policies and procedures under rule
38a-1 under the Act that are reasonably designed to ensure that all
notices sent to FGF and FGI shareholders with distributions under the
Plan (``Notices'') comply with condition II below, and that all other
written communications by FGF and FGI or its agents regarding
distributions under the Plan include the disclosure required by
condition III below. Applicants state that the Boards of FGF and FGI
each also adopted policies and procedures at that meeting that require
FGF and FGI to keep records that demonstrate each fund's compliance
with all of the conditions of the requested order and that are
necessary for each fund to form the basis for, or demonstrate the
calculation of, the amounts disclosed in its Notices.

Applicants' Legal Analysis

    1. Section 19(b) generally makes it unlawful for any registered
investment company to make long-term capital gains distributions more
than once each year. Rule 19b-1 limits the number of capital gains
dividends, as defined in section 852(b)(3)(C) of the Code
(``distributions''), that a fund may make with respect to any one
taxable year to one, plus a supplemental ``clean up'' distribution made
pursuant to section 855 of the Code not exceeding 10% of the total
amount distributed for the year, plus one additional capital gain
dividend made in whole or in part to avoid the excise tax under section
4982 of the Code.
    2. Section 6(c) provides that the Commission may, by order upon
application, conditionally or unconditionally exempt any person,
security, or transaction, or any class or classes of persons,
securities or transactions, from any provision of the Act, if and to
the extent that the exemption is necessary or appropriate in the public
interest and consistent with the protection of investors and the
purposes fairly intended by the policy and provisions of the Act.
    3. Applicants state that the one of the concerns underlying section
19(b) and rule 19b-1 is that shareholders might be unable to
differentiate between regular distributions of capital gains and
distributions of investment income. Applicants state, however, that
rule 19a-1 effectively addresses this concern by requiring that a
separate statement showing the sources of a distribution (e.g.,
estimated net income, net short-term capital gains, net long-term
capital gains and/or return of capital) accompany any distributions (or
the confirmation of the reinvestment of distributions) estimated to be
sourced in part from capital gains or capital. Applicants state that
the same information also is included in FGF's and FGI's annual reports
to shareholders and on their IRS Forms 1099-DIV, which are sent to each
common and preferred shareholder who received distributions during the
year.
    4. Applicants further state that each of FGF and FGI will make the
additional disclosures required by the conditions set forth below, and
each of them has adopted compliance policies and procedures in
accordance with rule 38a-1 to ensure that all required Notices and
disclosures are sent to shareholders. Applicants argue that by
providing the information required by section 19(a) and rule 19a-1, and
by complying with the procedures adopted under each Plan and the
conditions listed below, the funds would ensure that each fund's
shareholders are provided sufficient information to understand that
their periodic distributions are not tied to the fund's net investment
income (which for this purpose is the fund's taxable income other than
from capital gains) and realized capital gains to date, and may not
represent yield or investment return. Accordingly, applicants assert

that continuing to subject the funds to section 19(b) and rule 19b-1
would afford shareholders no extra protection.
    5. Applicants note that section 19(b) and rule 19b-1 also were
intended to prevent certain improper sales practices, including, in
particular, the practice of urging an investor to purchase shares of a
fund on the basis of an upcoming capital gains dividend (``selling the
dividend''), where the dividend would result in an immediate
corresponding reduction in NAV and would be in effect a taxable return
of the investor's capital. Applicants assert that the ``selling the
dividend'' concern should not apply to closed-end investment companies,
such as FGF and FGI, which do not continuously distribute shares.
According to Applicants, if the underlying concern extends to secondary
market purchases of shares of closed-end funds that are subject to a
large upcoming capital gains dividend, adoption of a Plan actually
helps minimize the concern by avoiding, through periodic distributions,
any buildup of large end-of-the-year distributions.
    6. Applicants also note that common shares of closed-end funds that
invest primarily in equity securities often trade in the marketplace at
a discount to their NAV. Applicants believe that this discount may be
reduced for closed-end funds that pay relatively frequent dividends on
their common shares at a consistent rate, whether or not those
dividends contain an element of long-term capital gain.
    7. Applicants assert that the application of rule 19b-1 to a Plan
actually could have an undesirable influence on portfolio management
decisions. Applicants state that, in the absence of an exemption from
rule 19b-1, the implementation of a Plan imposes pressure on management
(i) not to realize any net long-term capital gains until the point in
the year that the fund can pay all of its remaining distributions in
accordance with rule 19b-1, and (ii) not to realize any long-term
capital gains during any particular year in excess of the amount of the
aggregate pay-out for the year (since as a practical matter excess
gains must be distributed and accordingly would not be available to
satisfy pay-out requirements in following years), notwithstanding that
purely investment considerations might favor realization of long-term
gains at different times or in different amounts. Applicants thus
assert that the limitation on the number of capital gain distributions
that a fund may make with respect to any one year imposed by rule 19b-
1, may prevent the efficient operation of a Plan whenever that fund's
realized net long-term capital gains in any year exceed the total of
the periodic distributions that may include such capital gains under
the rule.
    8. In addition, Applicants assert that rule 19b-1 may cause fixed
regular periodic distributions under a Plan to be funded with returns
of capital \2\ (to the extent net investment income and realized short-
term capital gains are insufficient to fund the distribution), even
though realized net long-term capital gains otherwise could be
available. To distribute all of a fund's long-term capital gains within
the limits in rule 19b-1, a fund may be required to make total
distributions in excess of the annual amount called for by its Plan, or
to retain and pay taxes on the excess amount. Applicants thus assert
that the requested order would minimize these effects of rule 19b-1 by
enabling the funds to realize long-term capital gains as often as
investment considerations dictate without fear of violating rule 19b-1.
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    \2\ Returns of capital as used in the application means return
of capital for financial accounting purposes and not for tax
accounting purposes.
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    9. Applicants state that Revenue Ruling 89-81 under the Code
requires that a fund that has both common stock and preferred stock
outstanding designate the types of income, e.g., investment income and
capital gains, in the same proportion as the total distributions
distributed to each class for the tax year. To satisfy the
proportionate designation requirements of Revenue Ruling 89-81,
whenever a fund has realized a long-term capital gain with respect to a
given tax year, the fund must designate the required proportionate
share of such capital gain to be included in common and preferred stock
dividends. Applicants state that although rule 19b-1 allows a fund some
flexibility with respect to the frequency of capital gains
distributions, a fund might use all of the exceptions available under
the rule for a tax year and still need to distribute additional capital
gains allocated to the preferred stock to comply with Revenue Ruling
89-81.
    10. Applicants assert that the potential abuses addressed by
section 19(b) and rule 19b-1 do not arise with respect to preferred
stock issued by a closed-end fund. Applicants assert that such
distributions are fixed or determined in periodic auctions by reference
to short-term interest rates rather than by reference to performance of
the issuer and Revenue Ruling 89-81 determines the proportion of such
distributions that are comprised of the long-term capital gains.
    11. Applicants also submit that the ``selling the dividend''
concern is not applicable to preferred stock, which entitles a holder
to no more than a periodic dividend at a fixed rate or the rate
determined by the market, and, like a debt security, is priced based
upon its liquidation value, credit quality, and frequency of payment.
Applicants state that investors buy preferred shares for the purpose of
receiving payments at the frequency bargained for, and do not expect
the liquidation value of their shares to change.
    12. Applicants request an order under section 6(c) granting an
exemption from the provisions of section 19(b) and rule 19b-1 to permit
each fund's common stock to distribute periodic capital gains dividends
(as defined in section 852(b)(3)(C) of the Code) as often as monthly in
any one taxable year in respect of its common shares and as often as
specified by or determined in accordance with the terms thereof in
respect of its preferred shares.\3\
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    \3\ Applicants state that a future fund that relies on the
requested order will satisfy each of the representations in the
application except that such representations will be made in respect
of actions by the board of directors of such future fund and will be
made at a future time.
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Applicants' Conditions

    Applicants agree that, with respect to each fund seeking to rely on
the order, the order will be subject to the following conditions:

I. Compliance Review and Reporting

    The fund's chief compliance officer will: (a) report to the fund
Board, no less frequently than once every three months or at the next
regularly scheduled quarterly board meeting, whether (i) the fund and
the Adviser have complied with the conditions to the requested order,
and (ii) a Material Compliance Matter, as defined in rule 38a-1(e)(2),
has occurred with respect to compliance with such conditions; and (b)
review the adequacy of the policies and procedures adopted by the fund
no less frequently than annually.

II. Disclosures to Fund Shareholders

    A. Each Notice to the holders of the fund's common shares, in
addition to the information required by section 19(a) and rule 19a-1:
    1. Will provide, in a tabular or graphical format:
    (a) The amount of the distribution, on a per common share basis,
together with the amounts of such distribution amount, on a per common
share basis and as a percentage of such distribution amount, from
estimated: (A) Net investment income; (B) net realized

short-term capital gains; (C) net realized long-term capital gains; and
(D) return of capital or other capital source;
    (b) the fiscal year-to-date cumulative amount of distributions, on
a per common share basis, together with the amounts of such cumulative
amount, on a per common share basis and as a percentage of such
cumulative amount of distributions, from estimated: (A) Net investment
income; (B) net realized short-term capital gains; (C) net realized
long-term capital gains; and (D) return of capital or other capital
source;
    (c) the average annual total return in relation to the change in
NAV for the 5-year period (or, if the fund's history of operations is
less than five years, the time period commencing immediately following
the fund's first public offering) ending on the last day of the month
prior to the most recent distribution declaration date compared to the
current fiscal period's annualized distribution rate expressed as a
percentage of NAV as of the last day of the month prior to the most
recent distribution declaration date; and
    (d) the cumulative total return in relation to the change in NAV
from the last completed fiscal year to the last day of the month prior
to the most recent distribution declaration date compared to the fiscal
year-to-date cumulative distribution rate expressed as a percentage of
NAV as of the last day of the month prior to the most recent
distribution declaration date.
    Such disclosure shall be made in a type size at least as large and
as prominent as the estimate of the sources of the current
distribution; and
    2. will include the following disclosure:
    (a) ``You should not draw any conclusions about the fund's
investment performance from the amount of this distribution or from the
terms of the fund's Plan'';
    (b) ``The fund estimates that it has distributed more than its
income and net realized capital gains; therefore, a portion of your
distribution may be a return of capital. A return of capital may occur
for example, when some or all of the money that you invested in the
fund is paid back to you. A return of capital distribution does not
necessarily reflect the fund's investment performance and should not be
confused with `yield' or `income'''; \4\ and
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    \4\ This disclosure will be included only if the current
distribution or the fiscal year-to-date cumulative distributions are
estimated to include a return of capital.
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    (c) ``The amounts and sources of distributions reported in this
Notice are only estimates and are not being provided for tax reporting
purposes. The actual amounts and sources of the amounts for [accounting
and] tax reporting purposes will depend upon the fund's investment
experience during the remainder of its fiscal year and may be subject
to changes based on tax regulations. The fund will send you a Form
1099-DIV for the calendar year that will tell you how to report these
distributions for federal income tax purposes.''
    Such disclosure shall be made in a type size at least as large as
and as prominent as any other information in the Notice and placed on
the same page in close proximity to the amount and the sources of the
distribution.
    B. On the inside front cover of each report to shareholders under
rule 30e-1 under the Act, the fund will:
    1. Describe the terms of the Plan (including the fixed amount or
fixed percentage of the distributions and the frequency of the
distributions);
    2. include the disclosure required by condition II.A.2.a above;
    3. state, if applicable, that the Plan provides that the Board may
amend or terminate the Plan at any time without prior notice to fund
shareholders; and
    4. describe any reasonably foreseeable circumstances that might
cause the fund to terminate the Plan and any reasonably foreseeable
consequences of such termination.
    C. Each report provided to shareholders under rule 30e-1 and in
each prospectus filed with the Commission on Form N-2 under the Act,
will provide the fund's total return in relation to changes in NAV in
the financial highlights table and in any discussion about the fund's
total return.

III. Disclosure to Shareholders, Prospective Shareholders and Third
Parties

    A. The fund will include the information contained in the relevant
Notice, including the disclosure required by condition II.A.2 above, in
any written communication (other than a Form 1099) about the Plan or
distributions under the Plan by the fund, or agents that the fund has
authorized to make such communication on the fund's behalf, to any fund
common shareholder, prospective common shareholder or third-party
information provider;
    B. The fund will issue, contemporaneously with the issuance of any
Notice, a press release containing the information in the Notice and
will file with the Commission the information contained in such Notice,
including the disclosure required by condition II.A.2 above, as an
exhibit to its next filed Form N-CSR; and
    C. The fund will post prominently a statement on its (or the
Adviser's) Web site containing the information in each Notice,
including the disclosure required by condition II.A.2 above, and will
maintain such information on such Web site for at least 24 months.

IV. Delivery of 19(a) Notices to Beneficial Owners

    If a broker, dealer, bank or other person (``financial
intermediary'') holds common stock issued by the fund in nominee name,
or otherwise, on behalf of a beneficial owner, the fund: (a) Will
request that the financial intermediary, or its agent, forward the
Notice to all beneficial owners of the fund's shares held through such
financial intermediary; (b) will provide, in a timely manner, to the
financial intermediary, or its agent, enough copies of the Notice
assembled in the form and at the place that the financial intermediary,
or its agent, reasonably requests to facilitate the financial
intermediary's sending of the Notice to each beneficial owner of the
fund's shares; and (c) upon the request of any financial intermediary,
or its agent, that receives copies of the Notice, will pay the
financial intermediary, or its agent, the reasonable expenses of
sending the Notice to such beneficial owners.

V. Additional Board Determinations for Funds Whose Shares Trade at a
Premium

    If:
    A. The fund's common shares have traded on the exchange that they
primarily trade on at the time in question at an average premium to NAV
equal to or greater than 10%, as determined on the basis of the average
of the discount or premium to NAV of the fund's common shares as of the
close of each trading day over a 12-week rolling period (each such 12-
week rolling period ending on the last trading day of each week); and
    B. The fund's annualized distribution rate for such 12-week rolling
period, expressed as a percentage of NAV as of the ending date of such
12-week rolling period, is greater than the fund's average annual total
return in relation to the change in NAV over the 2-year period ending
on the last day of such 12-week rolling period; then:
    1. At the earlier of the next regularly scheduled meeting or within
four months of the last day of such 12-week rolling period, the Board
including a majority of the Independent Directors:
    (a) Will request and evaluate, and the Adviser will furnish, such
information

as may be reasonably necessary to make an informed determination of
whether the Plan should be continued or continued after amendment;
    (b) will determine whether continuation, or continuation after
amendment, of the Plan is consistent with the fund's investment
objective(s) and policies and in the best interests of the fund and its
shareholders, after considering the information in condition V.B.1.a
above; including, without limitation:
    (1) Whether the Plan is accomplishing its purpose(s);
    (2) the reasonably foreseeable effects of the Plan on the fund's
long-term total return in relation to the market price and NAV of the
fund's common shares; and
    (3) the fund's current distribution rate, as described in condition
V.B above, compared to with the fund's average annual total return over
the 2-year period, as described in condition V.B, or such longer period
as the board deems appropriate; and
    (c) based upon that determination, will approve or disapprove the
continuation, or continuation after amendment, of the Plan; and
    2. The Board will record the information considered by it and the
basis for its approval or disapproval of the continuation, or
continuation after amendment, of the Plan in its meeting minutes, which
must be made and preserved for a period of not less than six years from
the date of such meeting, the first two years in an easily accessible
place.

VI. Public Offerings

    The fund will not make a public offering of the fund's common
shares other than:
    A. a rights offering below NAV to holders of the fund's common
stock;
    B. an offering in connection with a dividend reinvestment plan,
merger, consolidation, acquisition, spin-off or reorganization of the
fund; or
    C. an offering other than an offering described in conditions VI.A
and VI.B above, unless, with respect to such other offering:
    1. the fund's average annual distribution rate for the six months
ending on the last day of the month ended immediately prior to the most
recent distribution declaration date,\5\ expressed as a percentage of
NAV per share as of such date, is no more than 1 percentage point
greater than the fund's average annual total return for the 5-year
period ending on such date; \6\ and
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    \5\ If the fund has been in operation fewer than six months, the
measured period will begin immediately following the fund's first
public offering.
    \6\ If the fund has been in operation fewer than five years, the
measured period will begin immediately following the fund's first
public offering.
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    2. the transmittal letter accompanying any registration statement
filed with the Commission in connection with such offering discloses
that the fund has received an order under section 19(b) to permit it to
make periodic distributions of long-term capital gains with respect to
its common stock as frequently as twelve times each year, and as
frequently as distributions are specified in accordance with the terms
of any outstanding preferred stock that such fund may issue.

VII. Amendments to Rule 19b-1

    The requested relief will expire on the effective date of any
amendment to rule 19b-1 that provides relief permitting certain closed-
end investment companies to make periodic distributions of long-term
capital gains with respect to their outstanding common stock as
frequently as twelve times each year.

    For the Commission, by the Division of Investment Management,
under delegated authority.
Florence E. Harmon,
Deputy Secretary.
[FR Doc. E9-416 Filed 1-12-09; 8:45 am]

BILLING CODE 8011-01-P


[Federal Register: March 7, 2008 (Volume 73, Number 46)]
[Notices]
[Page 12454]
[DOCID:fr07mr08-90]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-D-0142]

Draft Guidance for Industry and Review Staff on Nonclinical
Safety Evaluation of Reformulated Drug Products and Products Intended
for Administration by an Alternate Route; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance for industry and review staff entitled
``Nonclinical Safety Evaluation of Reformulated Drug Products and
Products Intended for Administration by an Alternate Route.'' The draft
guidance provides recommendations concerning development of safety
profiles to support approval of reformulated drug products and products
proposed for use by a route of administration for which the product was
not previously approved.

DATES:  Although you can comment on any guidance at any time (see 21
CFR 10.115(g)(5)), to ensure that the agency considers your comment on
this draft guidance before it begins work on the final version of the
guidance, submit written or electronic comments on the draft guidance
by May 6, 2008.

ADDRESSES:  Submit written requests for single copies of the draft
guidance to the Division of Drug Information (HFD-240), Center for Drug
Evaluation and Research, Food and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857. Send one self-addressed adhesive label to
assist that office in processing your requests. Submit written comments
on the draft guidance to the Division of Dockets Management (HFA-305),
Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville,
MD 20852. Submit electronic comments to http://www.regulations.gov. See
the SUPPLEMENTARY INFORMATION section for electronic access to the
draft guidance document.

FOR FURTHER INFORMATION CONTACT:  Paul Brown, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, rm. 5172, Silver Spring, MD 20993-0002, 301-
796-0856.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
and review staff entitled ``Nonclinical Safety Evaluation of
Reformulated Drug Products and Products Intended for Administration by
an Alternate Route.'' This draft guidance is intended for individuals
or organizations and review staff in the Center for Drug Evaluation and
Research involved in the development and review of new formulations of
products containing previously approved drug substances and proposals
for existing formulations to be used in a new route of administration.
This draft guidance assumes that the drug substance has already been
used in an approved drug product. It outlines the nonclinical
information generally recommended to support the development of a new
formulation containing a previously approved drug substance.
    This draft guidance also provides nonclinical evaluation
information for formulations intended for use by new routes of
administration even if there is no change in the composition of the
formulation. Although this situation does not represent a
reformulation, it is appropriate in this case to reevaluate the
toxicity information using considerations outlined in the draft
guidance.
    This draft guidance does not absolve the sponsor from providing
complete nonclinical information for a drug product, either directly or
through a right of reference to such information or by relying on the
finding of safety and effectiveness for a listed drug and establishing
a clinical bridge to that listed drug. This draft guidance pertains to
new formulations containing previously approved drug substances only
and does not address the safety evaluation of excipients.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the agency's current thinking on the safety
evaluation of reformulated drug products, including products intended
for administration by an alternate route. It does not create or confer
any rights for or on any person and does not operate to bind FDA or the
public. An alternative approach may be used if such approach satisfies
the requirements of the applicable statutes and regulations.

II. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this document.
Submit a single copy of electronic comments or two paper copies of any
mailed comments, except that individuals may submit one paper copy.
Comments are to be identified with the docket number found in brackets
in the heading of this document. Received comments may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
    Please note that on January 15, 2008, the FDA Web site transitioned
to the Federal Dockets Management System (FDMS). FDMS is a Government-
wide, electronic docket management system. Electronic submissions will
be accepted by FDA through FDMS only.

III. Electronic Access

    Persons with access to the Internet may obtain the document at
either http://www.fda.gov/cder/guidance/index.htm or http://
www.fda.gov/ohrms/dockets/default.htm.

    Dated: February 29, 2008.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E8-4481 Filed 3-6-08; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register Volume 84, Number 79 (Wednesday, April 24, 2019)]
[Notices]
[Pages 17213-17214]
[FR Doc No: 2019-08210]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-85692; File No. SR-Phlx-2019-16]

Self-Regulatory Organizations; Nasdaq PHLX LLC; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change To Extend the Pilot
Period for the Listing of P.M.-Settled Nasdaq-100 Index Options
Expiring on the Third Friday of the Month

April 18, 2019.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on April 12, 2019, Nasdaq PHLX LLC (``Phlx'' or ``Exchange'') filed
with the Securities and Exchange Commission (``Commission'') the
proposed rule change as described in Items I and II below, which Items
have been prepared by the Exchange. The Commission is publishing this
notice to solicit comments on the proposed rule change from interested
persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to extend the pilot period for the listing of
P.M.-settled Nasdaq-100 Index Options expiring on the third Friday of
the month (``NDXPM'').
    The text of the proposed rule change is available on the Exchange's
website at http://nasdaqphlx.cchwallstreet.com/, at the principal
office of the Exchange, 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
Statutory Basis for, the Proposed Rule Change

1. Purpose
    In August 2017, the Commission approved a proposed rule change for
the listing on the Exchange of NDXPM options on a pilot basis, with the
pilot to terminate on the earlier to occur of (i) 12 months following
the date of the first listing of the NDXPM options, or (ii) December
29, 2018 pursuant to Phlx Rule 1101A Commentary .05.\3\ Thereafter, the
Exchange amended Commentary .05 to Phlx Rule 1101A to extend the pilot
through May 6, 2019 because P.M.-settled options on the NASDAQ-100
Index (``NASDAQ-100'') had not yet been listed by Phlx.\4\
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    \3\ See Securities Exchange Act Release No. 81293 (August 2,
2017), 82 FR 37138 (August 8, 2017) (approving SR-Phlx-2017-04)
(Order Granting Approval of a Proposed Rule Change, as Modified by
Amendment Nos. 1 and 2, To Permit the Listing and Trading of P.M.-
Settled Nasdaq-100 Index Options on a Pilot Basis) (``Pilot'').
    \4\ See Securities Exchange Act Release No. 84685 (November 29,
2019 [sic]), 83 FR 62942 (December 6, 2018) (SR-Phlx-2018-76)
(Notice of Filing and Immediate Effectiveness of Proposed Rule
Change To Amend the Pilot Period for the Listing of P.M.-Settled
Nasdaq-100 Index Options Expiring on the Third Friday of the Month).
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    By way of background, the Pilot permits the listing and trading, on
a pilot basis, of NASDAQ-100 options with third-Friday-of-the month
expiration dates, whose exercise settlement value will be based on the
closing index value, symbol XQC, of the NASDAQ-100 on the expiration
day (``P.M.-settled''). In particular, NDXPM uses a $100 multiplier,
and the minimum trading increment will be $0.05 for options trading
below $3.00 and $0.10 for all other series. Strike price intervals are
set at no less than $5.00. Consistent with existing rules for index
options, the Exchange allows up to nine near term expiration months, as
well as LEAPS. The product will have European-style exercise and will
not be subject to position limits, though there would be enhanced
reporting requirements.
    The Exchange now proposes to amend Commentary .05 to Phlx Rule
1101A to extend the duration of the pilot program for these nonstandard
expirations through November 4, 2019. The Exchange continues to
experience technical programming delays related to P.M.-settled options
on the NASDAQ-100 and as a result, these option series have not yet
been listed by the Exchange. In order to allow sufficient time to
realize the benefits of a pilot program for NDXPM options, the Exchange
proposes the extension. By extending the outer limit of the pilot
period, the Exchange believes it will have adequate time to resolve the
programming issues, implement the listing of NDXPM options, and provide
the pilot reports associated with the initial approval order over a
meaningful period of time.\5\ Without the amendment, the pilot period
would end on May 6, 2019 and would not afford the Exchange or
Commission a sufficient period of time within which NDXPM options may
trade in order to be meaningfully evaluated by the Exchange as provided
in the August 2017 approval order.\6\ The Exchange will make public on
its website any data and analysis it submits to the Commission under
the pilot program.
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    \5\ The Exchange will issue an Options Trader Alert notifying
Members when NDXPM options are listed.
    \6\ See note 4 above.
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2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act,\7\ in general, and furthers the objectives of Section
6(b)(5) of the Act,\8\ in particular, in that it is designed to promote
just and equitable principles of trade, to remove impediments to and
perfect the mechanism of a free and open market and a national market
system, and, in general to protect investors and the public interest.
The Exchange believes the proposed rule change will protect investors
and the public interest by extending the pilot period for listing NDXPM
options until November 4, 2019, providing the Exchange, the Commission
and investors the benefit of a pilot program of sufficient duration to
yield meaningful information concerning the impact of NDXPM options on
the market.
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    \7\ 15 U.S.C. 78f(b).
    \8\ 15 U.S.C. 78f(b)(5).
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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. NDXPM options would be
available for trading to all market participants. The proposed rule
change will facilitate the listing and trading of a novel option
product that will enhance competition among market participants, to the
benefit of investors and the marketplace. The listing of NDXPM will
enhance competition by providing investors with an additional
investment vehicle, in a fully-electronic trading environment, through
which

investors can gain and hedge exposure to NASDAQ-100 stocks. Further,
this product could offer a competitive alternative to other existing
investment products that seek to allow investors to gain broad market
exposure. Also, the Exchange notes that it is possible for other
exchanges to develop or license the use of a new or different index to
compete with the NASDAQ-100 and seek Commission approval to list and
trade options on such an index.

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

    No written comments were either solicited or received.

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

    Because the foregoing proposed rule change does not: (i)
Significantly affect the protection of investors or the public
interest; (ii) impose any significant burden on competition; and (iii)
become operative for 30 days from the date on which it was filed, or
such shorter time as the Commission may designate, it has become
effective pursuant to Section 19(b)(3)(A) of the Act \9\ and Rule 19b-
4(f)(6) thereunder.\10\
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    \9\ 15 U.S.C. 78s(b)(3)(A).
    \10\ 17 CFR 240.19b-4(f)(6). As required under Rule 19b-
4(f)(6)(iii), the Exchange provided the Commission with written
notice of its intent to file the proposed rule change, along with a
brief description and the text of the proposed rule change, at least
five business days prior to the date of filing of the proposed rule
change, or such shorter time as designated by the Commission.
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    A proposed rule change filed under Rule 19b-4(f)(6) \11\ normally
does not become operative prior to 30 days after the date of the
filing. However, Rule 19b-4(f)(6)(iii) \12\ permits the Commission to
designate a shorter time if such action is consistent with the
protection of investors and the public interest. The Exchange has asked
the Commission to waive the 30-day operative delay so that the proposed
rule change may become effective and operative immediately upon filing.
The Exchange states that such waiver would allow the Exchange to extend
the pilot period for listing NDXPM options prior to the Pilot's
scheduled expiration, providing the Exchange, the Commission, and
investors the benefit of a pilot program of sufficient duration to
yield meaningful information concerning the impact of NDXPM options on
the market. For this reason, the Commission believes that waiving the
30-day operative delay is consistent with the protection of investors
and the public interest. Therefore, the Commission hereby waives the
30-day operative delay requirement and designates the proposed rule
change as operative upon filing.\13\
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    \11\ 17 CFR 240.19b-4(f)(6).
    \12\ 17 CFR 240.19b-4(f)(6)(iii).
    \13\ For purposes only of waiving the 30-day operative delay,
the Commission also has considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
---------------------------------------------------------------------------

    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 change should be approved or
disapproved.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to [email protected]. Please include
File Number SR-Phlx-2019-16 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-Phlx-2019-16. 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 website (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 website 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. Persons submitting comments are
cautioned that we do not redact or edit personal identifying
information from comment submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File Number SR-Phlx-2019-16 and should be submitted on
or before May 15, 2019.
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    \14\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\14\
Jill M. Peterson,
Assistant Secretary.
[FR Doc. 2019-08210 Filed 4-23-19; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 85, Number 71 (Monday, April 13, 2020)]
[Notices]
[Page 20492]
[FR Doc No: 2020-07690]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. AD10-12-011]

Increasing Market and Planning Efficiency and Enhancing
Resilience Through Improved Software; Supplemental Notice of Technical
Conference

    As announced in the Notice of Technical Conference issued on
February 14, 2020, the Federal Energy Regulatory Commission staff will
convene a technical conference on June 23, 24, and 25, 2020 to discuss
opportunities for increasing real-time and day-ahead market efficiency
and enhancing the resilience of the bulk power system through improved
software. The conference will no longer take place at Commission
headquarters as stated in the February 14 Notice but instead will take
place virtually via WebEx, with remote participation from both
presenters and attendees. Further details on remote attendance and
participation will be released prior to the conference.
    Attendees must still register through the Commission's website by
5:00 p.m. EST on June 12, 2020.\1\ WebEx connections may not be
available to those who do not register.
---------------------------------------------------------------------------

    \1\ The attendee registration form is located at https://www.ferc.gov/whats-new/registration/real-market-6-23-20-form.asp.
---------------------------------------------------------------------------

    The deadline for speaker nomination submissions has been extended
from April 17 to May 1, 2020. Speaker nominations must still be
submitted through the Commission's website.\2\
---------------------------------------------------------------------------

    \2\ The speaker nomination form is located at https://www.ferc.gov/whats-new/registration/real-market-6-23-20-speaker-form.asp.
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    Staff anticipates facilitating participant questions and
discussions of materials presented through WebEx. Details will be
released prior to the conference on how such discussions will take
place.
    There is an ``eSubscription'' link on the Commission's website 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_ADDRESS>or call (866) 208-
3676 (toll free). For TTY, call<PHONE_NUMBER>.
    The Commission will accept comments following the conference, with
a deadline of July 31, 2020. The technical conference will not be
transcribed.
    Commission conferences are accessible under section 508 of the
Rehabilitation Act of 1973. For accessibility accommodations, please
send an email to<EMAIL_ADDRESS>or call toll free 1-866-208-
3372 (voice) or<PHONE_NUMBER> (TTY); or send a fax to<PHONE_NUMBER> with
the required accommodations.
    For further information about this conference, please contact:
Sarah McKinley (Logistical Information) Office of External Affairs
(202) 502-8004<EMAIL_ADDRESS>    Alexander Smith (Technical Information) Office of Energy Policy and
Innovation<PHONE_NUMBER><EMAIL_ADDRESS>
    Dated: April 7, 2020.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2020-07690 Filed 4-10-20; 8:45 am]
 BILLING CODE 6717-01-P