3.2 0.05 0.10 1.00 0.16 0.26 1.16 Cotton Aerial 1.6 0 0.05 0.05 0.50 0.08 0.13 0.58 Table E 3. Estimated Environmental Concentrations ( lbs ai/ A) For Dry and Semi Aquatic Areas for a Single Application Site/ Application Method/ Rate of Application in lbs ai/ A Minimum Incorporatio n Depth ( cm) Runoff Value Sheet Runoff ( lbs ai/ A) Channelized Runoff ( lbs ai/ A) Drift ( lbs ai/ A) Total Loading to Adjacent Area ( Sheet Runoff Drift) 1/ Total Loading to Semi aquatic Area ( Channel Run off+ Drift) 2/

Page 68 of 72 1/ Dry area EEC / Seeding Emergence EC25, 2/ Semi aquatic EEC / Seeding Emergence EC25 The EC25 value of the most sensitive species in the seedling emergence study is compared to runoff and drift exposure to determine the risk quotient ( EEC/ toxicity value). The EC25 value of the most sensitive species in the vegetative vigor study is compared to the drift exposure to determine the acute risk quotient.

The NOEC or EC05 ( if NOEC is unavailable) value of the most sensitive species in the seedling emergence study is compared to runoff and drift exposure to determine the endangered species risk quotient. The NOEC or EC05 value of the most sensitive species in the vegetative vigor study is compared to the drift exposure to determine the endangered species risk quotient.

EECs and acute ( endangered species) risk quotients for terrestrial plants based on a single application are tabulated below. Risk quotients based on seedling emergence on NOEC or EC05 ranged from 5 to 48 for dry area and from 29 to 306 for semi aquatic areas. RQ values were 20 and 100 for ground application and aerial application, respectively ( Table 9).

Thus a single application, plant acute high risk and endangered species levels of concern are exceeded for terrestrial plants in dry areas and semi aquatic area at a registered maximum single application rate equal to or above 1.6 lb/ A. The results also implicate that for multiple applications, plant acute high risk and endangered species levels of concerns will exceeded for terrestrial plants in both dry and semiaquatic areas at a registered minimum label rate. Currently, EFED does not perform chronic risk assessments for terrestrial plants ii. Aquatic Plants Aquatic plant testing is required for diuron that has outdoor non residential terrestrial uses that may move off site by runoff ( solubility > 10 ppm in water), by drift ( aerial), or that is applied directly to aquatic use sites ( except residential). The registrant has chose to conduct Aquatic Tier II studies. For Aquatic Tier II studies, the following species should be tested at Tier II: Pseudokirchneria subcapitata, Lemna gibba, Skeletonema costatum, Anabaena flos aquae, and freshwater diatom.

Results of Tier II toxicity testing on the technical material are tabulated below.

Table E 4. Nontarget Aquatic Plant Toxicity ( Tier II)

Species % ai EC50/ ( ppb) MRID No. Author/ Year Study Classification Vascular Plants Table E 4. Nontarget Aquatic Plant Toxicity ( Tier II)

Species % ai EC50/ ( ppb) MRID No. Author/ Year Study Classification Page 69 of 72 Duckweed Lemna gibba

 Nonvascular Plants Green algae Selenastrum capricornutum 96.8 2.4 42218401/ Blasberg & Hicks/ 1991 Core Green algae Dunaliella tertiolecta 95 20 40228401/ Mayer, F. L./ 1986 Supplemental Green algae Chlamydomonas sp. 95 37 40228401/ Mayer, F. L./ 1986 Supplemental Green algae Chlorococcum sp. 95 10 40228401/ Mayer, F. L./ 1986 Supplemental Green algae Chlorella sp. 95 19 40228401/ Mayer, F. L./ 1986 Supplemental Green algae Neochloris sp. 95 28 40228401/ Mayer, F. L./ 1986 Supplemental Marine diatom Skeletonema costatum _ _ _ _

Marine diatom Phaeodactylum tricornutum 95 10 40228401/ Mayer, F. L./ 1986 Supplemental Freshwater diatom Navicula pelliculosa _ _ _ _

Freshwater diatom Thallssiosira fluviatilus 95 95 40228401/ Mayer, F. L./ 1986 Supplemental Blue green algae Anabaena flos aquae _ _ _ _

Algae Monochrysis lutheri 95 18 40228401/ Mayer, F. L./ 1986 Supplemental Algae Isochrysis galbana 95 10 40228401/ Mayer, F. L./ 1986 Supplemental Algae Cyclotella nana _ _ _ _

Algae Achnanthes brevipes 95 24 40228401/ Mayer, F. L./ 1986 Supplemental Algae Navicula incerta 95 93 40228401/ Mayer, F. L./ 1986 Supplemental Algae Stauroneis amphoroides 95 31 40228401/ Mayer, F. L./ 1986 Supplemental Algae Amphora exigua 95 31 40228401/ Mayer, F. L./ 1986 Supplemental Table E 4. Nontarget Aquatic Plant Toxicity ( Tier II)

Species % ai EC50/ ( ppb) MRID No. Author/ Year Study Classification Page 70 of 72 Algae Nitzschia closterium sp 95 50 40228401/ Mayer, F. L./ 1986 Supplemental The Tier II results indicate that only the study with Green algae Selenastrum capricornutum toxicity study is acceptable. All other studies submitted is not acceptable because the plant species not recommended species ( Table E4).

ii. Aquatic Plants Exposure to nontarget aquatic plants may occur through runoff or spray drift from adjacent treated sites or directly from such uses as aquatic weed or mosquito larvae control. An aquatic plant risk assessment for acute high risk is usually made for aquatic vascular plants from the surrogate duckweed Lemna gibba. Non vascular acute high aquatic plant risk assessments are performed using either algae or a diatom, whichever is the most sensitive species. An aquatic plant risk assessment for acute endangered species is usually made for aquatic vascular plants from the surrogate duckweed Lemna gibba. To date there are no known non vascular plant species on the endangered species list. Runoff and drift exposure is computed from either GENEEC or PRIZM3/ EXAMS 2.95 ( GENEEC II used). The risk quotient is determined by dividing the pesticide's initial or peak concentration in water by the plant EC50 value.

Based on an EC50 value for green algae ( EC50 = 0.0021 ppm) and EEC value ranged from 0.022 mg/ l to 0.412 ppm, acute risk quotients for non vascular plants are from 9.58 to 171.67. Based on these RQ values, the results indicate that plant acute high risk and endangered species levels of concern are exceeded for nonvascular plants at registered minimum label rate of 1.6 lbs. ai/ A.( Table 10). However, acute RQ for vascular aquatic plant and endanger species ane not calculated because lack of duckweed ( Lemna gibba) toxicity data. Currently, EFED does not perform assessments for chronic risk to aquatic plants.

Appendix 4 Environmental Fate and Transport Studies Reviewed ( 4) MRID No. 41418804 ( 161 1) Hawkins, D. R. et al. 1988. The hydrolytic stability of 14C diuron, 21 April 1988. Huntingdon Research Center, Report No. HRC/ DPT 177/ 88698. EFGWB 90 0737.

( 5) MRID No. 41418805 ( 161 2) Hawkins, D. R. et al. 1988. The photodegradation of 14C diuron in water, 30 August 1988. Huntingdon Research Center, Report No. HRC/ DPT 177/ 881179. EFGWB 90 0737.

( 6) MRID No. 41719302 ( 161 3) Stevenson, I. E. 1990b. Photodegradation of [ phenyl( U) 14C] diuron on soil under artificial sunlight. Laboratory Project ID: AMR 771 87. Unpublished study performed by Biospherics, Inc., Rockville, MD, and Cambridge Analytical Associates, Boston, MA, and submitted by E. I. du Pont de Nemours and Company, Wilmington, DE. Page 71 of 72 ( 7) MRID No. 4179303 ( 162 1) Hawkins, D. R., D. Kirkpatrick, D. Shaw, and S. C. Chan. 1990. The metabolism of [ phenyl( U) 14C] diuron in Keyport silt loam soil under aerobic conditions. Du Pont Report No. AMR 1202 88. Huntingdon Research Center Report No. HRC/ DPT 189/ 891860. Unpublished study performed by Huntingdon Research Centre, Huntingdon, Cambridgeshire, England, and submitted by E. I du Pont de Nemours & Company, Inc., Wilmington, DE.

( 8) MRID No. 41418806 ( 162 2) Yu, W. C. 1988. Anaerobic soil metabolism of [ phenyl( U) 14C] diuron, 30 August 1988. Cambridge Analytical Associates.

( 9) MRID No. 44221001 ( 162 3) Hausmann, S. M. 1992. Anaerobic aquatic metabolism of [ phenyl( U) 14C] diuron. Laboratory Project ID: AMR 2067 91. Unpublished study performed and submitted by E. I. du Pont de Nemours and Company, Wilmington, DE.

( 10) MRID No: 44221002 ( 162 4) Hausmann, S. M., and G. M. Kraut. 1992. Aerobic aquatic metabolism of [ phenyl( U) 14C] diuron. Laboratory Project ID: AMR 2066 91. Unpublished study performed and submitted by E. I. du Pont de Nemours and Company, Wilmington, DE.

( 11) MRID No. 444490501 ( 163 1) Bramble, F. Q., F. D. Behmke, and G. I. Norwood. 1998. Batch equilibrium ( adsorption/ desorption) of 14C diuron, fenuron, and N'( 3 chlorophenyl) N, N dimethylurea on soil. DuPont Project ID: AMR 4584 97. Unpublished study performed and submitted by E. I. du Pont de Nemours and Company, Wilmington, DE.

( 12) MRID No. 444865001 ( 164 1) Bramble, F. Q. Jr., F. D. Behmke, R. S. Frizzel., and G. I. Norwwod. July 2, 1998. Field soil dissipation of diuron following application of Karmex DF herbicide. Performed by E. I. du pont de Nemorous and Company, Wilmington, DE 19880 0402. Sponsored by E. I. du pont de Nemorous and Company, Wilmington, DE 19898. Report No. AMR 4383 97.

( 10) MRID No. 44865001 ( 164 1) Tweedy, B. G. June 28, 1999. Field soil dissipation of diuron following application of Karmex DF herbicide. Performed by ABC Laboratories, Columbia, MO. Sponsored by Griffin LLC, P. O. Box 1847, Valdosta, GA 31603 1847. Project Identification No. GP98 084 ( 7B) MRID No: 44386701 Page 72 of 72


[Federal Register Volume 76, Number 87 (Thursday, May 5, 2011)]
[Notices]
[Page 25726]
[FR Doc No: 2011-10931]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. IC-29663]

Notice of Applications for Deregistration Under Section 8(f) of
the Investment Company Act of 1940

April 29, 2011.
    The following is a notice of applications for deregistration under
section 8(f) of the Investment Company Act of 1940 for the month of
April 2011. A copy of each application may be obtained via the
Commission's Web site by searching for the file number, or an applicant
using the Company name box, at http://www.sec.gov/search/search.htm or
by calling<PHONE_NUMBER>. An order granting each application will be
issued unless the SEC orders a hearing. Interested persons may request
a hearing on any application by writing to the SEC's Secretary at the
address below and serving the relevant applicant with a copy of the
request, personally or by mail. Hearing requests should be received by
the SEC by 5:30 p.m. on May 24, 2011, and should be accompanied by
proof of service on the applicant, 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 Secretary, U.S. Securities and
Exchange Commission, 100 F Street, NE., Washington, DC 20549-1090.
    For Further Information Contact: Diane L. Titus at<PHONE_NUMBER>,
SEC, Division of Investment Management, Office of Investment Company
Regulation, 100 F Street, NE., Washington, DC 20549-4041.

Federated American Leaders Fund, Inc. [File No. 811-1704]

    Summary: Applicant seeks an order declaring that it has ceased to
be an investment company. On September 18, 2009, applicant transferred
its assets to Federated Clover Value Fund, a series of Federated Equity
Funds, based on net asset value. Expenses of approximately $577,896
incurred in connection with the reorganization were paid by applicant,
Federated Equity Management Company of Pennsylvania, applicant's
investment adviser, or its affiliates.
    Filing Dates: The application was filed on April 12, 2011 and
amended on April 26, 2011.
    Applicant's Address: Federated Investors Funds, 4000 Ericsson Dr.,
Warrendale, PA 15086-7561.

Banknorth Funds [File No. 811-10021]

    Summary: Applicant seeks an order declaring that it has ceased to
be an investment company. On August 27, 2004, applicant transferred its
asset to corresponding series of Federated Equity Funds, Federated
Total Return Series, Inc., and Federated Municipal Securities Income
Trust, based on net asset value. Expenses of approximately $71,914
incurred in connection with the reorganization were paid by Federated
Equity Company of Pennsylvania and Federated Investment Management
Company, the investment advisers to the surviving funds, or their
affiliates.
    Filing Dates: The application was filed on February 4, 2011 and two
amendments were filed on April 7, 2011.
    Applicant's Address: Federated Investors Tower, 1001 Liberty Ave.,
Pittsburgh, PA 15222-3779.

Tortoise Total Return Fund, LLC [File No. 811-22085]

    Summary: Applicant, a closed-end investment company, seeks an order
declaring that it has ceased to be an investment company. On January 5,
2011, applicant made a final liquidating distribution to its
shareholders, based on net asset value. Expenses of approximately
$14,996 incurred in connection with the liquidation were paid by
applicant. Applicant has retained approximately $10,188 in cash to pay
any remaining outstanding expenses.
    Filing Dates: The application was filed on February 15, 2011 and
amended on April 8, 2011.
    Applicant's Address: 11550 Ash St., Suite 300, Leawood, KS 66211.

Neuberger Berman Income Opportunity Fund [File No. 811-21334] Neuberger
Berman High Yield Strategies Fund [File No. 811-21342]

    Summary: Each applicant, a closed-end investment company, seeks an
order declaring that it has ceased to be an investment company. On
August 6, 2010, each applicant transferred its assets to Neuberger
Berman High Yield Strategies Fund Inc., based on net asset value. Each
applicant's preferred stockholders received an equivalent number of
shares of preferred stock of the acquiring fund. Expenses of $200,000
were incurred in connection with each reorganization and were paid by
the respective applicant.
    Filing Date: The applications were filed on March 28, 2011.
    Applicants' Address: 605 Third Ave., 2nd Floor, New York, NY 10158-
0180.

Greenwich Advisors Trust [File No. 811-21996]

    Summary: Applicant seeks an order declaring that it has ceased to
be an investment company. On February 25, 2011, applicant made a
liquidating distribution to its shareholders, based on net asset value.
Expenses of $28,680 incurred in connection with the liquidation were
paid by applicant and Greenwich Advisors LLC, applicant's investment
adviser.
    Filing Date: The application was filed on March 31, 2011.
    Applicant's Address: Greenwich Advisors LLC, 330 Railroad Ave.,
Greenwich, CT 06830.

BlackRock Apex Municipal Fund, Inc. [File No. 811-5227]

    Summary: Applicant, a closed-end investment company, seeks an order
declaring that it has ceased to be an investment company. On February
28, 2011, applicant transferred its assets to BlackRock MuniAssets
Fund, Inc., based on net asset value. Expenses of approximately
$203,515 incurred in connection with the reorganization were paid by
applicant.
    Filing Date: The application was filed on April 4, 2011.
    Applicant's Address: 100 Bellevue Parkway, Wilmington, DE 19809.

Lord Abbett Municipal Income Trust [File No. 811-6418]

    Summary: Applicant seeks an order declaring that it has ceased to
be an investment company. On November 19, 2010, applicant transferred
its assets to Lord Abbett Municipal Income Fund, Inc., based on net
asset value. Expenses of $150,000 incurred in connection with the
reorganization were paid by Lord, Abbett & Co. LLC, applicant's
investment adviser.
    Filing Date: The application was filed on March 30, 2011.
    Applicant's Address: 90 Hudson St., Jersey City, NJ 07302.

    For the Commission, by the Division of Investment Management,
pursuant to delegated authority.
 Cathy H. Ahn,
Deputy Secretary.
[FR Doc. 2011-10931 Filed 5-4-11; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 82, Number 177 (Thursday, September 14, 2017)]
[Notices]
[Pages 43276-43278]
[FR Doc No: 2017-19536]

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SECURITIES AND EXCHANGE COMMISSION

[Investment Company Act Release No. 32811; 812-14782]

Innovator ETFs Trust, et al.

September 11, 2017.
AGENCY: Securities and Exchange Commission (``Commission'').

ACTION: Notice.

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    Notice of an application for an order under section 6(c) of the
Investment Company Act of 1940 (the ``Act'') for an exemption from
sections 2(a)(32), 5(a)(1), 22(d), and 22(e) of the Act and rule 22c-1
under the Act, under sections 6(c) and 17(b) of the Act for an
exemption from sections 17(a)(1) and 17(a)(2) of the Act, and under
section 12(d)(1)(J) for an exemption from sections 12(d)(1)(A) and
12(d)(1)(B) of the Act. The requested order would permit (a) index-
based series of certain open-end management investment companies
(``Funds'') to issue shares redeemable in large aggregations only
(``Creation Units''); (b) secondary market transactions in Fund shares
to occur at negotiated market prices rather than at net asset value
(``NAV''); (c) certain Funds to pay redemption proceeds, under certain
circumstances, more than seven days after the tender of shares for
redemption; (d) certain affiliated persons of a Fund to deposit
securities into, and receive securities from, the Fund in connection
with the purchase and redemption of Creation Units; and (e) certain
registered management investment companies and unit investment trusts
outside of the same group of investment companies as the Funds (``Funds
of Funds'') to acquire shares of the Funds.

Applicants:  Innovator ETFs Trust (formerly, Academy Funds Trust)
(``Trust''), a Delaware statutory trust registered under the Act as an
open-end management investment company with multiple series, Innovator
Capital Management, LLC (``Innovator''), Delaware limited liability
company registered as an investment adviser under the Investment
Advisers Act of 1940, and Quasar Distributors, LLC (``Distributor''), a
Delaware limited liability company and broker-dealer registered under
the Securities Exchange Act of 1934 (``Exchange Act'').

Filing Dates: The application was filed on June 7, 2017, and amended on
September 8, 2017.

Hearing or Notification of Hearing: An order granting the requested
relief will be issued unless the Commission orders a hearing.
Interested persons may request a hearing by writing to the Commission's
Secretary and serving applicants with a copy of the request, personally
or by mail. Hearing requests should be received by the Commission by
5:30 p.m. on October 5, 2017, and should be accompanied by proof of
service on applicants, in the form of an affidavit, or for lawyers, a
certificate of service. Pursuant to rule 0-5 under the Act, hearing
requests should state the nature of the writer's interest, any facts
bearing upon the desirability of a hearing on the matter, the reason
for the request, and the issues contested. Persons who wish to be
notified of a hearing may request notification by writing to the
Commission's Secretary.

ADDRESSES: Secretary, Securities and Exchange Commission, 100 F Street
NE., Washington, DC 20549-1090; Applicants: Innovator and the Trust,
120 N. Hale Street, Suite 200, Wheaton IL, 60187; the Distributor, 615
East Michigan Street, Milwaukee, Wisconsin 53202.

FOR FURTHER INFORMATION CONTACT: Jill Ehrlich, Senior Counsel, at (202)
551-6819, or Andrea Ottomanelli Magovern, Acting Branch Chief, at (202)
551-6821 (Division of Investment Management, Chief Counsel's Office).

SUPPLEMENTARY INFORMATION: The following is a summary of the

application. The complete application may be obtained via the
Commission's Web site by searching for the file number, or for an
applicant using the Company name box, at http://www.sec.gov/search/search.htm or by calling<PHONE_NUMBER>.

Summary of the Application

    1. Applicants request an order that would allow Funds to operate as
index exchange traded funds (``ETFs'').\1\ Fund shares will be
purchased and redeemed at their NAV in Creation Units only. All orders
to purchase Creation Units and all redemption requests will be placed
by or through an ``Authorized Participant,'' which will have signed a
participant agreement with the Distributor. Shares will be listed and
traded individually on a national securities exchange, where share
prices will be based on the current bid/offer market. Any order
granting the requested relief would be subject to the terms and
conditions stated in the application (``Application'').\2\
---------------------------------------------------------------------------

    \1\ Applicants request that the order apply to the series of the
Trust identified and described in an appendix to the Application and
any additional series of the Trust, and any other open-end
management investment company or series thereof (each, included in
the term ``Fund''), each of which will operate as an ETF and will
track a specified index comprised of domestic and/or foreign equity
securities and/or domestic and/or foreign fixed income securities
(each, an ``Underlying Index''). Each Fund will (a) be advised by
Innovator or an entity controlling, controlled by, or under common
control with Innovator (each, an ``Adviser'') and (b) comply with
the terms and conditions of the Application.
    \2\ Prior to May 9, 2017, Innovator Management LLC (``Innovator
Management'') served as the Trust's investment adviser. (Innovator
and Innovator Management are not affiliated persons of each other.)
Innovator Management entered into an agreement with Innovator
pursuant to which Innovator Management transferred the assets of its
investment advisory business and related intellectual property to
Innovator (the ``Transaction''). The closing of the Transaction (the
``Closing'') occurred on May 9, 2017. The Commission previously
granted relief to Innovator Management, the Trust, and the
Distributor that, other than the identity of the investment adviser,
was identical in all material respects to that requested in the
Application. Innovator Management LLC, et al., Investment Company
Act Release Nos. 31996 (Feb. 12, 2016) (notice) and 32026 (Mar. 9,
2016) (order) (``Existing Order''). On May 5, 2017, the Commission
staff provided oral no-action relief to Innovator, the Trust, and
the Distributor to rely on the Existing Order until the earlier of
the receipt of any order granted by the Commission on the
Application or 150 days from the date of the Closing.
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    2. Each Fund will hold investment positions selected to correspond
generally to the performance of an Underlying Index. In the case of
Self-Indexing Funds, an affiliated person, as defined in section
2(a)(3) of the Act (``Affiliated Person''), or an affiliated person of
an Affiliated Person (``Second-Tier Affiliate''), of the Trust or a
Fund, of the Adviser, of any sub-adviser to or promoter of a Fund, or
of the Distributor will compile, create, sponsor or maintain the
Underlying Index.\3\
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    \3\ Each Self-Indexing Fund will post on its Web site the
identities and quantities of the investment positions that will form
the basis for the Fund's calculation of its NAV at the end of the
day. Applicants believe that requiring Self-Indexing Funds to
maintain full portfolio transparency will help address, together
with other protections, conflicts of interest with respect to such
Funds.
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    3. Shares will be purchased and redeemed in Creation Units and
generally on an in-kind basis. Except where the purchase or redemption
will include cash under the limited circumstances specified in the
Application, purchasers will be required to purchase Creation Units by
depositing specified instruments (``Deposit Instruments''), and
shareholders redeeming their shares will receive specified instruments
(``Redemption Instruments''). The Deposit Instruments and the
Redemption Instruments will each correspond pro rata to the positions
in the Fund's portfolio (including cash positions) except as specified
in the Application.
    4. Because shares will not be individually redeemable, applicants
request an exemption from section 5(a)(1) and section 2(a)(32) of the
Act that would permit the Funds to register as open-end management
investment companies and issue shares that are redeemable in Creation
Units only.
    5. Applicants also request an exemption from section 22(d) of the
Act and rule 22c-1 under the Act as secondary market trading in shares
will take place at negotiated prices, not at a current offering price
described in a Fund's prospectus, and not at a price based on NAV.
Applicants state that (a) secondary market trading in shares does not
involve a Fund as a party and will not result in dilution of an
investment in shares, and (b) to the extent different prices exist
during a given trading day, or from day to day, such variances occur as
a result of third-party market forces, such as supply and demand.
Therefore, applicants assert that secondary market transactions in
shares will not lead to discrimination or preferential treatment among
purchasers. Finally, applicants represent that share market prices will
be disciplined by arbitrage opportunities, which should prevent shares
from trading at a material discount or premium from NAV.
    6. With respect to Funds that effect creations and redemptions of
Creation Units in kind and that are based on certain Underlying Indexes
that include foreign securities, applicants request relief from the
requirement imposed by section 22(e) in order to allow such Funds to
pay redemption proceeds within fourteen calendar days following the
tender of Creation Units for redemption. Applicants assert that the
requested relief would not be inconsistent with the spirit and intent
of section 22(e) to prevent unreasonable, undisclosed or unforeseen
delays in the actual payment of redemption proceeds.
    7. Applicants request an exemption to permit Funds of Funds to
acquire Fund shares beyond the limits of section 12(d)(1)(A) of the
Act; and the Funds, and any principal underwriter for the Funds, and/or
any broker or dealer registered under the Exchange Act, to sell shares
to Funds of Funds beyond the limits of section 12(d)(1)(B) of the Act.
The Application's terms and conditions are designed to, among other
things, help prevent any potential (i) undue influence over a Fund
through control or voting power, or in connection with certain
services, transactions, and underwritings, (ii) excessive layering of
fees, and (iii) overly complex fund structures, which are the concerns
underlying the limits in sections 12(d)(1)(A) and (B) of the Act.
    8. Applicants request an exemption from sections 17(a)(1) and
17(a)(2) of the Act to permit persons that are Affiliated Persons, or
Second-Tier Affiliates, of the Funds, solely by virtue of certain
ownership interests, to effectuate purchases and redemptions in-kind.
The deposit procedures for in-kind purchases of Creation Units and the
redemption procedures for in-kind redemptions of Creation Units will be
the same for all purchases and redemptions and Deposit Instruments and
Redemption Instruments will be valued in the same manner as those
investment positions currently held by the Funds. Applicants also seek
relief from the prohibitions on affiliated transactions in section
17(a) to permit a Fund to sell its shares to and redeem its shares from
a Fund of Funds, and to engage in the accompanying in-kind transactions
with the Fund of Funds.\4\ The purchase of Creation Units by a Fund of
Funds directly from a Fund will be accomplished in accordance with the

policies of the Fund of Funds and will be based on the NAVs of the
Funds.
---------------------------------------------------------------------------

    \4\ The requested relief would apply to direct sales of shares
in Creation Units by a Fund to a Fund of Funds and redemptions of
those shares. Applicants, moreover, are not seeking relief from
section 17(a) for, and the requested relief will not apply to,
transactions where a Fund could be deemed an Affiliated Person, or a
Second-Tier Affiliate, of a Fund of Funds because an Adviser or an
entity controlling, controlled by or under common control with an
Adviser provides investment advisory services to that Fund of Funds.
---------------------------------------------------------------------------

    9. Section 6(c) of the Act permits the Commission to exempt any
persons or transactions from any provision of the Act if such exemption
is necessary or appropriate in the public interest and consistent with
the protection of investors and the purposes fairly intended by the
policy and provisions of the Act. Section 12(d)(1)(J) of the Act
provides that the Commission may exempt any person, security, or
transaction, or any class or classes of persons, securities, or
transactions, from any provision of section 12(d)(1) if the exemption
is consistent with the public interest and the protection of investors.
Section 17(b) of the Act authorizes the Commission to grant an order
permitting a transaction otherwise prohibited by section 17(a) if it
finds that (a) the terms of the proposed transaction are fair and
reasonable and do not involve overreaching on the part of any person
concerned; (b) the proposed transaction is consistent with the policies
of each registered investment company involved; and (c) the proposed
transaction is consistent with the general purposes of the Act.

    For the Commission, by the Division of Investment Management,
under delegated authority.
Eduardo A. Aleman.
Assistant Secretary.
[FR Doc. 2017-19536 Filed 9-13-17; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register: March 24, 2010 (Volume 75, Number 56)]
[Notices]
[Page 14153-14154]
[DOCID:fr24mr10-51]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2010-0038; FRL-8815-1]

National Advisory Committee for Acute Exposure Guideline Levels
for Hazardous Substances; Notice of Public Meeting

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: A meeting of the National Advisory Committee for Acute
Exposure Guideline Levels for Hazardous Substances (NAC/AEGL Committee)
will be held on April 13-15, 2010, in San Francisco, CA. At this
meeting, the NAC/AEGL Committee will address, as time permits, the
various aspects of the acute toxicity and the development of Acute
Exposure Guideline Levels (AEGLs) for the following chemicals: 1,3-
butadiene; acetaldehyde; acrylonitrile; arsenic trioxide; benzene;
bromine pentafluoride; butane; carbon dioxide; chlorine pentafluoride;
chloroacetone; dichlorvos; hexane; hydrogen bromide; hydrogen iodide;
ketene; methyl isothiocyanate; methylene chloride; monoethanolamine;
nerve agent VX; nitric oxide; oleum; propargyl alcohol;
propionaldehyde; red phosphorus; ricin; selenium hexafluoride; sulfur
trioxide; sulfuric acid; trichloroethylene; and vinyl chloride.

DATES: A meeting of the NAC/AEGL Committee will be held from 10 a.m. to
5 p.m. on April 13, 2010; from 8 a.m. to 5 p.m. on April 14, 2010; and
from 8 a.m. to 12 p.m. on April 15, 2010. To request accommodation of a
disability, please contact the Designated Federal Officer (DFO) listed
under FOR FURTHER INFORMATON CONTACT, preferably at least 10 days prior
to the meeting, to give EPA as much time as possible to process your
request.

ADDRESSES: The meeting will be held at the Mark Hopkins Inter-
Continental Hotel, Number One Nob Hill, San Francisco, CA 94108.

FOR FURTHER INFORMATION CONTACT: Paul S. Tobin, DFO, Risk Assessment
Division (7403M), Office of Pollution Prevention and Toxics, 1200
Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number:
(202) 564-8557; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    This action is directed to the public in general. This action may
be of particular interest to anyone who may be affected if the AEGL
values are adopted by government agencies for emergency planning,
prevention, or response programs, such as EPA's Risk Management Program
under the Clean Air Act and Amendments Section 112r. It is possible
that other Federal agencies besides EPA, as well as State agencies and
private organizations, may adopt the AEGL values for their programs. As
such, the Agency has not attempted to describe all the specific
entities that may be affected by this action. If you have any questions
regarding the applicability of this action to a particular entity,
consult the person listed under FOR FURTHER INFORMATION CONTACT.

B. How Can I Get Copies of this Document and Other Related Information?

    EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPPT-2010-0038. All documents in the
docket are listed in the docket index available at http://
www.regulations.gov. Although listed in the index, some information is
not publicly available, e.g., Confidential Business Information (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 electronically at http://www.regulations.gov, or, if only
available in hard copy, at the OPPT Docket. The OPPT Docket is located
in the EPA Docket Center (EPA/DC) at Rm. 3334, EPA West Bldg., 1301
Constitution Ave., NW., Washington, DC. The EPA/DC Public Reading Room
hours of operation are 8:30 a.m. to 4:30 p.m., Monday through Friday,
excluding legal holidays. The telephone number of the EPA/DC Public
Reading Room is<PHONE_NUMBER>, and the telephone number for the OPPT
Docket is<PHONE_NUMBER>. Docket visitors are required to show
photographic identification, pass through a metal detector, and sign
the EPA visitor log. All visitor bags are processed through an X-ray
machine and subject to search. Visitors will be provided an EPA/DC
badge that must be visible at all times in the building and returned
upon departure.

II. Meeting Procedures

    For additional information on the scheduled meeting, the agenda of
the NAC/AEGL Committee, or the submission of information on chemicals
to be discussed at the meeting, contact the DFO.
    The meeting of the NAC/AEGL Committee will be open to the public.
Oral presentations or statements by interested parties will be limited
to 10 minutes. Interested parties are encouraged to contact the DFO to
schedule presentations before the NAC/AEGL Committee. Since seating for
outside observers may be limited, those wishing to attend the meeting
as observers are also encouraged to contact the DFO at the earliest
possible date to ensure adequate seating arrangements. Inquiries
regarding oral presentations and the submission of written statements
or chemical-specific information should be directed to the DFO.

III. Future Meetings

    Another meeting of the NAC/AEGL Committee is planned for Winter
2010.

List of Subjects

    Environmental protection, Chemicals, Hazardous substances, Health.

    Dated: March 17, 2009.
 Wendy C. Hamnett,
Director, Office of Pollution Prevention and Toxics.
[FR Doc. 2010-6487 Filed 3-23-10; 8:45 am]
BILLING CODE 6560-50-S


[Federal Register Volume 79, Number 200 (Thursday, October 16, 2014)]
[Notices]
[Page 62132]
[FR Doc No: 2014-24562]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER15-55-000]

Blackwell Solar, LLC; Supplemental Notice That Initial Market-
Based Rate Filing Includes Request for Blanket Section 204
Authorization

    This is a supplemental notice in the above-referenced proceeding,
of Blackwell Solar, LLC's application for market-based rate authority,
with an accompanying rate schedule, noting that such application
includes a request for blanket authorization, under 18 CFR Part 34, of
future issuances of securities and assumptions of liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street NE., Washington,
DC 20426, in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone
filing a motion to intervene or protest must serve a copy of that
document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR Part 34, of future issuances of securities and assumptions of
liability is October 28, 2014.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
5 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First Street NE., Washington, DC 20426.
    The filings in the above-referenced proceeding(s) are accessible in
the Commission's eLibrary system by clicking on the appropriate link in
the above list. They are also 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_ADDRESS>or
call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.

    Dated: October 8, 2014.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2014-24562 Filed 10-15-14; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 84, Number 207 (Friday, October 25, 2019)]
[Notices]
[Pages 57439-57441]
[FR Doc No: 2019-23334]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-4611]

Compliance Policy Guide Sec. 400.400 Conditions Under Which
Homeopathic Drugs May Be Marketed; Withdrawal of Guidance

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; withdrawal.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the withdrawal of Compliance Policy Guide Sec. 400.400 (CPG 400.400)
entitled ``Conditions Under Which Homeopathic Drugs May be Marketed,''
which was issued in 1988.

DATES: The withdrawal is applicable October 25, 2019.

FOR FURTHER INFORMATION CONTACT: Elaine Lippmann, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6238, Silver Spring, MD 20993, 301-796-
3600.

SUPPLEMENTARY INFORMATION: FDA is withdrawing CPG 400.400, entitled
``Conditions Under Which Homeopathic Drugs May be Marketed,'' which was
issued in 1988. CPG 400.400 described an enforcement policy regarding
homeopathic drug products.
    Under section 505(a) of the Federal Food, Drug, and Cosmetic Act
(FD&C Act) (21 U.S.C. 355(a)), before any ``new drug'' is marketed, it
must be the subject of an approved application filed pursuant to
section 505(b) or section 505(j) of the FD&C Act. The requirements in
section 505 of the FD&C Act apply to biological products regulated
under section 351 of the Public Health Service Act (PHS Act) (42 U.S.C.
262); however, as stated in section 351(j) of the PHS Act, a biological
product with an approved license under section 351(a) of the PHS Act is
not required to have an approved application under section 505 of the
FD&C Act. Accordingly, absent a determination that a homeopathic drug
product is not a ``new drug'' under section 201(p) of the FD&C Act (21
U.S.C. 321(p)), all homeopathic drug products are subject to the
premarket approval requirements in section 505 of the FD&C Act or
section 351 of the PHS Act. There are currently no homeopathic drug
products approved by FDA.
    Since the issuance of CPG 400.400, the Agency has encountered
multiple situations in which homeopathic drug products posed a
significant risk to patients. There is a broad misconception that all
homeopathic products are highly diluted and generally composed of
``natural'' ingredients, and that they are therefore incapable of
causing harm. However, as with all drugs, the safety of homeopathic
drugs depends upon many factors, such as the product's intended use,
dosage form, frequency of use, manufacturing quality, intended patient
population, and the quantity and combination of ingredients. CPG
400.400 does not directly address all these important considerations.
    For example, FDA has encountered situations in which homeopathic
products either caused or could have caused significant harm, even
though the products, as labeled, appeared to meet the conditions
described in CPG 400.400. In 2016, FDA's search of the FDA Adverse
Event Reporting System database identified 99 cases of adverse events
consistent with belladonna toxicity, including reports of infant deaths
and seizures, possibly related to teething products. Multiple
homeopathic drug products were identified as associated with this
safety concern. Further investigation revealed that the poisonous
belladonna alkaloids in some of the products far exceeded the labeled
amounts, raising a serious safety concern. As another example, by 2009,
FDA had received more than 130 reports of anosmia (loss of the sense of
smell) associated with the use of Zicam homeopathic intranasal zinc
products. FDA determined that if the products were used as labeled, a
user would receive significant daily intranasal exposure to zinc,
raising a serious safety concern. These are only two examples among
many. FDA has also, for example, documented many serious violations of
current good manufacturing practice (CGMP) requirements by
manufacturers of homeopathic drug products, raising significant
concerns about the safety of the products made with inadequate process
controls.
    The homeopathic drug industry has grown significantly since FDA
issued CPG 400.400 in 1988. According to the National Health Interview
Survey, conducted by the Centers for Disease Control and Prevention's
National Center for Health Statistics, between 2007 and 2012 the use of
homeopathic products increased by approximately 15 percent in U.S.
adults. This growth, and the increased population exposure that it
apparently represents, has contributed to FDA's enhanced focus on the
safety of homeopathic drugs in recent years and the evaluation of the
CPG, which was issued over three decades ago.
    In light of the growth of the industry and passage of time since
the issuance of CPG 400.400, FDA announced on March 27, 2015, that it
was evaluating its regulatory framework for homeopathic drug products.
In April 2015, FDA held a public hearing to obtain information and
comments from stakeholders about the current use of homeopathic drug
products, as well as the Agency's regulatory framework for such
products (Docket No. FDA-2015-N-0540; available at https://www.regulations.gov/docket?D=FDA-2015-N-0540). FDA sought broad public
input on its enforcement policies related to homeopathic drug products
to better promote and protect the public health. On December 18, 2017,
FDA issued a draft guidance entitled ``Drug Products Labeled as
Homeopathic; Guidance for FDA Staff and Industry.'' The draft guidance
detailed a risk-based enforcement policy, prioritizing enforcement and
regulatory actions for certain categories of homeopathic products that
potentially pose higher risk to public health.
    In response to comments received, we have revised the draft
guidance and are announcing the reissue of it elsewhere in this issue
of the Federal Register to enable the public to review and comment
before it is finalized. In particular, we have added a definition of
``homeopathic drug product'' for purposes of the guidance, added an
additional explanation of some of the safety issues that contributed to
the development of the draft guidance, and clarified the intent to use
risk-based factors to prioritize enforcement and regulatory actions
involving homeopathic products that are marketed without required FDA
approval. In addition, the revised draft guidance removes the statement
that the Agency will withdraw the CPG simultaneous with the issuance of
the final guidance.
    As a result of the Agency's ongoing evaluation of its regulatory
framework, including consideration of the public input received on this
issue and the recent growth of safety concerns associated with
homeopathic drug products, FDA believes that it is appropriate to
withdraw CPG 400.400 at this time, rather than waiting for the issuance
of the final guidance. Because CPG 400.400 is inconsistent with the
Agency's risk-based approach to enforcement generally, it does not
accurately reflect the Agency's current thinking. When the draft
guidance is finalized, it will specify the categories of products that
the Agency intends to prioritize for enforcement. In the interim,
before the draft guidance is finalized, FDA intends to apply its
general approach to prioritizing regulatory and enforcement action,
which involves risk-based prioritization in light of all the facts of a
given circumstance. Risk-based enforcement best reflects FDA's public
health priorities.
    We note that withdrawing the CPG does not represent a change in the
legal obligations that apply to homeopathic drugs under the statutes
FDA administers. The definition of a ``drug'' under section
201(g)(1)(A) through (C) of the FD&C Act includes: (1) Articles
recognized in the official United States Pharmacopoeia or the official
Homoeopathic Pharmacopoeia of the United States; (2) articles intended
for use in the diagnosis, cure, mitigation, treatment, or prevention of
disease in man or other animals; and (3) articles (other than food)
intended to affect the structure or any function of the body of man or
other animals. As such, homeopathic drugs are subject to the same
regulatory requirements as other drugs; nothing in the FD&C Act exempts
homeopathic drug products from any of the requirements in the FD&C Act,
including those related to approval, adulteration, and misbranding.

    Generally, a drug, including a homeopathic drug, is considered a
``new drug'' if it is not generally recognized as safe and effective by
qualified experts for use under the conditions prescribed, recommended,
or suggested in the labeling (section 201(p) of the FD&C Act). CPG
400.400 did not, and legally could not, provide a path for legal
marketing of unapproved new drugs, including those that are
homeopathic. Rather, the CPG merely described an enforcement policy
regarding homeopathic drug products. The Agency does not have authority
to exempt a product or class of products that are new drugs under the
FD&C Act from the new drug approval requirements of the FD&C Act. (See
Cutler v. Kennedy, 475 F. Supp. 838, 856 (D.D.C. 1979); Hoffman-LaRoche
v. Weinberger, 425 F. Supp. 890, 892-894 (D.D.C. 1975). See also Util.
Air Regulatory Grp. v. EPA, 573 U.S. 302, 327 (2014) (``An agency
confronting resource constraints may change its own conduct, but it
cannot change the law.'')).
    The Agency's interest in its general risk-based enforcement
approach also justifies withdrawing an outdated policy that does not
reflect that approach. Additionally, withdrawal of the CPG is
appropriate given the recent growth of safety concerns associated with
homeopathic drug products--including concerns regarding products
associated with serious adverse events and otherwise presenting
significant safety risks and serious violations of CGMP requirements--
and the increasing number of consumer exposures due to the continued
expansion of the homeopathic industry since issuance of the CPG.

    Dated: October 22, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-23334 Filed 10-24-19; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 86, Number 190 (Tuesday, October 5, 2021)]
[Notices]
[Pages 54992-54993]
[FR Doc No: 2021-21633]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

[Docket No. USCG-2021-0734]

Policy Letter: Change 1 to CG-MMC Policy Letter 02-18, Guidelines
for Qualifications of Personnel for Issuing STCW Endorsements for Basic
and Advanced Polar Code Operations

AGENCY: Coast Guard, Homeland Security (DHS).

ACTION: Notice of availability.

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SUMMARY: The Coast Guard announces the availability of Change 1 to CG-
MMC Policy Letter 02-18, Guidelines for Qualifications of Personnel for
Issuing STCW Endorsements for Basic and Advanced Polar Code Operations.
The Coast Guard will use applicable regulations and this policy to
evaluate whether mariners may be issued endorsements for Basic and
Advanced Polar Code Operations.

DATES: The policies announced in Change 1 to CG-MMC Policy Letter 02-18
are effective as of September 20, 2021.

ADDRESSES: To view the policy letter mentioned in this notice, search
the docket number USCG-2021-0734 using the Federal eRulemaking Portal
at https://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: For information about this document,
contact James Cavo, Mariner Credentialing Program Policy Division (CG-
MMC-2), Coast Guard; telephone<PHONE_NUMBER>; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: This change revises CG-Policy Letter 02-18
to include the requirements for renewal of Basic and Advanced Polar
Code Operations endorsements. Renewal requirements for these
endorsements were not included in the original policy letter. Methods
to qualify for renewal of an STCW endorsement in Polar Code Operations
will include completion of refresher training, evidence of being a
qualified instructor of a Basic or Advanced Polar Code Operations
course at least twice within the past five years, or sea service.
    The professional requirements to renew a merchant mariner
credential (MMC) in 46 CFR 10.227 include the option to present
evidence of at least 1 year of sea service during the past 5 years.
However, Section A-I/11 paragraph 4.1 of the STCW Code only requires 2
months of seagoing service within the previous 5 years for renewal of
Basic and Advanced Polar Code endorsements. To align with the STCW
requirements and to ensure the seagoing service requirement for the
renewal of a Polar Code Operations endorsement does not exceed the
seagoing service requirement to initially qualify for Polar Code
Operations endorsement, the seagoing service requirement for renewal of
Polar Code Operations endorsements will be 2 months of seagoing service
in the previous 5 years. Mariners will also need to meet the applicable
requirements in 46 CFR 10.227 for the renewal of their MMC.
    This change also removes transitional provisions that expired on
July 1, 2020.
    This notice is issued under authority of 5 U.S.C. 552(a).

    Dated: September 20, 2021.
J.G. Lantz,
U.S. Coast Guard, Director of Commercial Regulations and Standards.
[FR Doc. 2021-21633 Filed 10-4-21; 8:45 am]
BILLING CODE 9110-04-P