[Federal Register: October 16, 2006 (Volume 71, Number 199)]
[Notices]
[Page 60775-60781]
[DOCID:fr16oc06-106]

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SECURITIES AND EXCHANGE COMMISSION

[Investment Company Act Release No. 27511; 812-12993]

SSgA Funds Management, Inc., et al.; Notice of Application

October 6, 2006.
AGENCY: Securities and Exchange Commission.

ACTION: Notice of an application for an order under section 12(d)(1)(J)
of the Investment Company Act of 1940 (``Act'') for an exemption from
sections 12(d)(1)(A) and (B), 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 6(c) of the Act to amend a previous order.

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    Summary of the Application: The order would permit certain
management investment companies and unit investment trusts (``UITs'')
registered under the Act to acquire shares (``Shares'') of certain
open-end management investment companies and UITs registered under the
Act that operate as exchange-traded funds and are outside of the same
group of investment companies as the acquiring investment companies.
The order also would amend a prior order (the ``Prior Order'') \1\ to
permit: (a) Dealers to sell Shares to purchasers in the secondary
market unaccompanied by a prospectus when prospectus delivery is not
required by the Securities Act of 1933 (``Securities Act''); (b) under
certain circumstances, exchange-traded funds that track certain foreign
equity securities indexes to pay redemption proceeds more than seven
days after the tender of Shares (in large aggregations called
``Creation Units'') for redemption; and (c) additional exchange-traded
funds that track certain foreign equity securities indexes to rely on
the Prior Order. Further, the order would add certain representations
and terms concerning the operations of exchange-traded funds that track
certain foreign equity securities indexes, replace certain conditions,
and add a condition, to the Prior Order.
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    \1\ State Street Bank and Trust Company, et al., Investment
Company Act Release Nos. 24631 (Sept. 1, 2000) (notice) and 24666
(Sept. 25, 2000) (``Prior Order''), superseding The Select Sector
SPDR Trust, et al., Investment Company Act Release Nos. 23492 (Oct.
20, 1998) (notice) and 23534 (Nov. 13, 1998) (order).
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    Applicants: SSgA Funds Management, Inc. (the ``Adviser''), ALPS
Distributors, Inc., and State Street Global Markets, LLC (each, a
``Distributor'' and together, the ``Distributors''), The Select Sector
SPDR [supreg]Trust (``Select Sector Trust''), streetTRACKS [supreg]
Series Trust (``Series Trust''), and streetTRACKS [supreg] Index Shares
Funds (``Index Shares Funds'') (each of Select Sector Trust, Series
Trust, and Index Shares Funds, a ``Trust'' and collectively, the
``Trusts'').

DATES: The application was filed on July 29, 2003 and amended on August
3, 2006. Applicants have agreed to file an amendment during the notice
period, the substance of which is reflected in the notice.
    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 October
31, 2006, 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, U.S. Securities and Exchange Commission, 100 F
Street, NE., Washington, DC 20549-1090; Applicants, c/o Scott M.
Zoltowski, Esq., State Street Bank and Trust Company, Two Avenue de
Lafayette-6th Floor, Boston, Massachusetts 02111.

FOR FURTHER INFORMATION CONTACT: Laura J. Riegel, Senior Counsel, at
(202) 551-6873, or Michael W. Mundt, Senior Special Counsel, at (202)
551-6821 (Office of Investment Company Regulation, Division of
Investment Management).

SUPPLEMENTARY INFORMATION: The following is a summary of the
application. The complete application may be obtained for a fee at the
Public Reference Branch, U.S. Securities and Exchange Commission, 100 F
Street, NE., Washington, DC 20549-0102 (tel.<PHONE_NUMBER>).

Applicants' Representations

    1. The Trusts are open-end management investment companies
registered under the Act, each of which consists of separate series
that seek to provide investment results that correspond generally to
the price and yield performance or total return of, its specified
equity securities index (an ``Index'') and operate as exchange-traded
funds. Index Shares Funds is the only Trust that currently offers
series based on Indexes comprised of foreign equity securities
(``Foreign Indexes'').\2\ The Adviser is registered as an investment
adviser under the Investment Advisers Act of 1940 (``Advisers Act'')
and serves as investment adviser to each Trust. ALPS Distributors,
Inc., a broker-dealer registered under the Securities Exchange Act of
1934 (the ``Exchange Act'') serves as the principal underwriter for
each series of Select Sector Trust. State Street Global Markets, LLC, a
broker-dealer registered under the Exchange Act, serves as the
principal underwriter for each series of Series Trust and Index Shares
Funds.
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    \2\ These series, streetTRACKS [supreg] Dow Jones STOXX 50 Fund
and streetTRACKS [supreg] Dow Jones EURO STOXX 50 Fund, currently
operate in reliance on an order that is not the Prior Order. If the
requested order is granted, those series will operate in reliance on
the Prior Order, as amended.
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    2. Applicants request an exemption under section 12(d)(1)(J) of the
Act to permit certain management investment companies and UITs
registered under the Act to acquire Shares beyond the limitations in
sections 12(d)(1)(A) and (B). Applicants request that the relief apply
to (a) each open-end management investment company or UIT registered
under the Act that operates as an exchange-traded fund, is currently or
subsequently part of the same ``group of investment companies'' as the
Trusts within the meaning of section 12(d)(1)(G)(ii) of the Act, and is
advised or sponsored by the Adviser or an entity controlling,
controlled by or under common control with the Adviser (such registered
management investment companies are referred to as ``Open-End ETFs'';
such registered UITs are referred to as ``UIT ETFs''; Open-End ETFs and
UIT ETFs are collectively referred to as ``ETFs''),\3\ as well as any
principal underwriter of an Open-End ETF or broker or dealer registered
under the Exchange Act (``Broker'') selling Shares of an ETF to an
Investing Fund (as defined below); and (b) each management investment
company or UIT registered under the Act that is not part of the same
``group of investment companies'' as the ETFs within the meaning of
section 12(d)(1)(G)(ii) of the Act and that enters into a participation
agreement with an ETF (such management investment companies are
referred to as ``Investing Management Companies''; such UITs are
referred to as ``Investing Trusts,'' and Investing Management Companies
and Investing Trusts are collectively referred to as ``Investing
Funds'').\4\ Each Investing Trust will have a sponsor (``Sponsor'').
Each Investing Management Company will be advised by an investment
adviser within the meaning of section 2(a)(20)(A) of the Act
(``Investing Fund Adviser'') and may be advised by investment
adviser(s) within the meaning of section 2(a)(20)(B) of the Act
(``Investing Fund Subadviser''). Any investment adviser to any
Investing Management Company will be registered as an investment
adviser under the Advisers Act or exempt from registration. In
addition, applicants request relief from sections 17(a)(1) and 17(a)(2)
of the Act to permit the ETFs that are or become affiliated persons of
an Investing Fund to sell Shares to, and redeem Shares from the
Investing Fund.
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    \3\ Investing Funds do not include the ETFs. All existing ETFs
are open-end management investment companies.
    \4\ All entities that currently intend to rely on the requested
order are named as applicants. Any other entity that relies on the
order in the future will comply with the terms and conditions of the
application. An Investing Fund may rely on the requested order only
to invest in ETFs and not in any other registered investment
company.
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    3. Applicants also request relief under section 6(c) of the Act to
amend the Prior Order to: (a) Add exemptions from sections 22(e) and
24(d) of the Act; (b) replace certain conditions and add a new
condition, to the Prior Order; (c) add certain terms and
representations concerning the creation and redemption of Creation
Units of ETFs that track Foreign Indexes (``Foreign ETFs''), as
described in the application; (d) permit Foreign ETFs to invest in
depositary receipts as component securities and/or alternatives to
component securities of the relevant Foreign Index \5\; and (e) permit
additional series of Index Shares Funds that would track Foreign
Indexes (``New Foreign ETFs''; included in the term ``Foreign ETFs'')
\6\ to rely on the Prior Order. Applicants assert that the New Foreign
ETFs will operate in a manner substantially similar to the existing
Foreign ETFs and will comply with all of the terms and conditions of
the Prior Order, as amended.
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    \5\ Any depositary receipts held by a Foreign ETF will be
negotiable securities that represent ownership of a non-U.S.
company's publicly traded stock. Depositary receipts will typically
be American depositary receipts, but may include Global depositary
receipts, and Euro depositary receipts. The Adviser may include
depositary receipts on the list of deposit securities of an ETF when
holding the depositary receipt will improve liquidity, tradability,
or settlement for a Foreign ETF and may treat the depositary receipt
of a component security of the Foreign Index as a component security
for purposes of applicants' representations related to the
percentage of assets of a Foreign ETF that will be invested in
component securities.
    \6\ The Foreign Indexes for the New Foreign ETFs are S&P/
Citigroup BMI World ex-US Index, S&P/Citigroup BMI EPAC Index, S&P/
Citigroup BMI Europe Index, S&P/Citigroup BMI Asia Pacific Index,
S&P/Citigroup BMI Emerging Markets Index, S&P/Citigroup BMI Latin
America Index, S&P/Citigroup BMI Middle-East & Africa Index, S&P/
Citigroup BMI European Emerging Index, S&P/Citigroup BMI Asia
Pacific Emerging Index, S&P/Citigroup BMI China Index, S&P/Citigroup
BMI World ex-US Cap Range <  2 Billion USD Index, MSCI ACWI ex-US
Index, Russell/Nomura PRIMETM Index, Russell/Nomura Small
CapTM Index, Dow Jones Wilshire ex-US Real Estate
Securities Index, and Macquarie Global Infrastructure 100 Index.
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Applicants' Legal Analysis

    1. Section 6(c) of the Act provides that the Commission may exempt
any person, security or transaction, or any class of persons,
securities or transactions, from any provision of the

Act, if and to the extent that 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 thereof, from any of the provisions 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
exempt a proposed transaction from section 17(a) if evidence
establishes that the terms of the transaction, including the
consideration to be paid or received, are fair and reasonable and do
not involve overreaching on the part of any person concerned, and the
proposed transaction is consistent with the policies of the registered
investment company and the general provisions of the Act.

Section 12(d)(1) of the Act

    2. Section 12(d)(1)(A) of the Act prohibits a registered investment
company from acquiring shares of an investment company if the
securities represent more than 3% of the total outstanding voting stock
of the acquired company, more than 5% of the total assets of the
acquiring company, or, together with the securities of any other
investment companies, more than 10% of the total assets of the
acquiring company. Section 12(d)(1)(B) of the Act prohibits a
registered open-end investment company, its principal underwriter, or
any broker or dealer registered under the Exchange Act, from selling
its shares to another investment company if the sale will cause the
acquiring company to own more than 3% of the acquired company's voting
stock, or if the sale will cause more than 10% of the acquired
company's voting stock to be owned by investment companies generally.
Applicants seek an exemption under section 12(d)(1)(J) to permit the
Investing Funds to acquire Shares in an ETF beyond the limits of
section 12(d)(1)(A) and Open-end ETFs and any principal underwriter of
an Open-end ETF or Broker to sell Shares of Open-end ETFs to the
Investing Funds beyond the limits set forth in sections 12(d)(1)(B).
    3. Applicants state that the proposed arrangement and conditions
will adequately address the policy concerns underlying sections
12(d)(1)(A) and (B), which include concerns about undue influence by a
fund of funds over underlying funds, excessive layering of fees, and
overly complex fund structures. Accordingly, applicants believe that
the requested exemption is consistent with the public interest and the
protection of investors.
    4. Applicants believe that neither the Investing Funds nor an
Investing Fund Affiliate would be able to exert undue influence over
the ETFs.\7\ To limit the control that an Investing Fund may have over
an ETF, applicants propose a condition prohibiting the Investing Fund
Adviser or Sponsor, any person controlling, controlled by, or under
common control with the Investing Fund Adviser or Sponsor, and any
investment company or issuer that would be an investment company but
for sections 3(c)(1) or 3(c)(7) of the Act that is advised or sponsored
by the Investing Fund Adviser or Sponsor, or any person controlling,
controlled by, or under common control with the Investing Fund Adviser
or Sponsor (``Investing Fund Adviser Group'') from controlling
(individually or in the aggregate) an ETF within the meaning of section
2(a)(9) of the Act. The same prohibition would apply to the Investing
Fund Subadviser, any person controlling, controlled by or under common
control with the Investing Fund Subadviser, and any investment company
or issuer that would be an investment company but for section 3(c)(1)
or 3(c)(7) of the Act (or portion of such investment company or issuer)
advised or sponsored by the Investing Fund Subadviser or any person
controlling, controlled by or under common control with the Investing
Fund Subadviser (``Investing Fund Subadviser Group''). Applicants
propose other conditions to limit the potential for undue influence
over the ETFs, including that no Investing Fund or Investing Fund
Affiliate (except to the extent it is acting in its capacity as an
investment adviser to an Open-end ETF or sponsor to a UIT ETF) will
cause an ETF to purchase a security in any offering of securities
during the existence of any underwriting or selling syndicate of which
a principal underwriter is an Underwriting Affiliate (``Affiliated
Underwriting''). An ``Underwriting Affiliate'' is a principal
underwriter in any underwriting or selling syndicate that is an
officer, director, member of an advisory board, Investing Fund Adviser,
Investing Fund Subadviser, employee or Sponsor of the Investing Fund,
or a person which any such officer, director, member of an advisory
board, Investing Fund Adviser, Investing Fund Subadviser, employee or
Sponsor is an affiliated person (except any person whose relationship
to the ETF is covered by section 10(f) of the Act is not an
Underwriting Affiliate).
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    \7\ An ``Investing Fund Affiliate'' is an Investing Fund
Adviser, Investing Fund Subadviser, Sponsor, promoter, principal
underwriter of an Investing Fund, and any person controlling,
controlled by, or under common control with any of those entities.
An ``ETF Affiliate'' is the investment adviser(s), promoter,
sponsor, and principal underwriter of an ETF, and any person
controlling, controlled by, or under common control with any of
those entities.
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    5. Applicants do not believe the proposed arrangement will involve
excessive layering of fees. The board of directors or trustees of each
Investing Management Company, including a majority of the disinterested
directors or trustees, will find that the advisory fees charged to the
Investing Management Company are based on services provided that will
be in addition to, rather than duplicative of, services provided under
the advisory contract(s) of any Open-end ETF in which the Investing
Management Company may invest. In addition, an Investing Fund Adviser
or trustee (``Trustee'') or Sponsor of an Investing Trust will waive
fees otherwise payable to it by the Investing Management Company or
Investing Trust, as applicable, in an amount at least equal to any
compensation (including fees received pursuant to any plan adopted by
an Open-end ETF under rule 12b-1 under the Act) received from an ETF by
the Investing Fund Adviser, Trustee or Sponsor or an affiliated person
of the Investing Fund Adviser, Trustee or Sponsor, other than advisory
fees paid to the Adviser or its affiliated person by an ETF, in
connection with the investment by the Investing Management Company or
Investing Trust, as applicable, in the ETF. Applicants state that any
sales charges or service fees charged with respect to shares of an
Investing Fund will not exceed the limits applicable to a fund of funds
set forth in Conduct Rule 2830 of the NASD.
    6. Applicants submit that the proposed arrangement will not create
an overly complex fund structure. Applicants note that no ETF may
acquire securities of any investment company or company relying on
section 3(c)(1) or 3(c)(7) of the Act in excess of the limits contained
in section 12(d)(1)(A) of the Act. Applicants also represent that to
ensure that Investing Funds comply with the terms and conditions of the
requested relief from section 12(d)(1), any Investing Fund that intends
to invest in an ETF in reliance on the requested order will be required
to enter into a participation agreement between the relevant Trust on
behalf of the ETF(s) and the Investing Fund. The participation
agreement will require the Investing Fund to adhere to the terms

and conditions of the requested order. The participation agreement also
will include an acknowledgement from the Investing Fund that it may
rely on the order only to invest in the ETFs and not in any other
investment company. The participation agreement will further require
any Investing Fund that exceeds the 5% or 10% limitations in sections
12(d)(1)(A)(ii) and (iii) to disclose in its prospectus that it may
invest in ETFs, and to disclose, in ``plain English,'' in its
prospectus the unique characteristics of the Investing Fund investing
in ETFs, including but not limited to the expense structure and any
additional expenses of investing in ETFs.

Section 17(a) of the Act

    7. Section 17(a) of the Act generally prohibits sales or purchases
of securities between a registered investment company and any
affiliated person of the company. Section 2(a)(3) of the Act defines an
``affiliated person'' of another person to include any person 5% or
more of whose outstanding voting securities are directly or indirectly
owned, controlled, or held with power to vote by the other person.
    8. Applicants seek relief from section 17(a) to permit an ETF that
is an affiliated person of an Investing Fund because the Investing Fund
holds 5% or more of the ETF's Shares to sell its Shares to and redeem
its Shares from an Investing Fund (and to engage in in-kind
transactions in conjunction with those sales and redemptions).\8\
Applicants believe that any proposed transactions directly between ETFs
and Investing Funds will be consistent with the policies of each ETF
and Investing Fund. The participation agreement will require any
Investing Fund that purchases Creation Units directly from an ETF to
represent that the purchase of Creation Units from an ETF by an
Investing Fund will be accomplished in compliance with the investment
restrictions of the Investing Fund and will be consistent with the
investment policies set forth in the Investing Fund's registration
statement.\9\
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    \8\ Applicants acknowledge that receipt of any compensation by
(a) an affiliated person of an Investing Fund, or an affiliated
person of such person, for the purchase by the Investing Fund of
shares of an ETF or (b) an affiliated person of an ETF, or an
affiliated person of such person, for the sale by the ETF of its
shares to an Investing Fund is subject to section 17(e) of the Act.
The participation agreement also will include this acknowledgment.
    \9\ Applicants believe that an Investing Fund will purchase
Shares in the secondary market and will not purchase or redeem
Creation Units directly from an ETF. Nonetheless, an Investing Fund
that owns 5% or more of an ETF could seek to transact in Creation
Units directly with an ETF pursuant to the section 17(a) relief
requested.
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Section 22(e) of the Act

    9. Applicants seek to amend the Prior Order to add relief from
section 22(e) of the Act. Section 22(e) generally prohibits a
registered investment company from suspending the right of redemption
or postponing the date of payment of redemption proceeds for more than
seven days after the tender of a security for redemption. The principal
reason for the requested exemption is that settlement of redemptions
for the Foreign ETFs is contingent not only on the settlement cycle of
the United States market, but also on currently practicable delivery
cycles in local markets for underlying foreign securities held by the
Foreign ETFs. Applicants state that local market delivery cycles for
transferring certain foreign securities to investors redeeming Creation
Units, together with local market holiday schedules, will under certain
circumstances require a delivery process in excess of seven calendar
days for the Foreign ETFs. Applicants request relief under section 6(c)
from section 22(e) in such circumstances to allow the Foreign ETFs to
pay redemption proceeds up to 14 calendar days after the tender of a
Creation Unit for redemption. At all other times and except as
disclosed in the relevant prospectus and/or statement of additional
information (``SAI''), applicants expect that each Foreign ETF will be
able to deliver redemption proceeds within seven days.\10\ With respect
to future Foreign ETFs, applicants seek the same relief from section
22(e) only to the extent that circumstances similar to those described
in the application exist.
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    \10\ Rule 15c6-1 under the Exchange Act requires that most
securities transactions be settled within three business days of the
trade. Applicants acknowledge that no relief obtained from the
requirements of section 22(e) will affect any obligations applicants
may have under rule 15c6-1.
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    10. Applicants state that section 22(e) was designed to prevent
unreasonable, undisclosed and unforeseen delays in the payment of
redemption proceeds. Applicants assert that the requested relief will
not lead to the problems that section 22(e) was designed to prevent.
Applicants state that the SAI will disclose those local holidays (over
the period of at least one year following the date of the SAI), if any,
that are expected to prevent the delivery of redemption proceeds in
seven calendar days, and the maximum number of days needed to deliver
the proceeds for the relevant Foreign ETF.

Section 24(d) of the Act

    11. Applicants seek to amend the Prior Order to add relief from
section 24(d) of the Act. Section 24(d) provides, in relevant part,
that the prospectus delivery exemption provided to dealer transactions
by section 4(3) of the Securities Act does not apply to any transaction
in a redeemable security issued by an open-end investment company.
Applicants request relief under section 6(c) from section 24(d) to
permit dealers selling Shares to rely on the prospectus delivery
exemption provided by section 4(3) of the Securities Act.\11\
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    \11\ Applicants state that they are not seeking seek relief from
the prospectus delivery requirement for non-secondary market
transactions, such as when an investor purchases Shares from the
relevant Trust or an underwriter. Applicants state that the
prospectus will caution broker-dealers and others purchasing
Creation Units that some activities on their part, depending on the
circumstances, may result in their being deemed statutory
underwriters and subject them to the prospectus delivery and
liability provisions of the Securities Act. For example, a broker-
dealer firm and/or its client may be deemed a statutory underwriter
if it takes Creation Units after placing an order with the relevant
Distributor, breaks them down into the constituent Shares and sells
them directly to its customers, or if it chooses to couple the
creation of new Shares with an active selling effort involving
solicitation of secondary market demand for Shares. The prospectus
will state that whether a person is an underwriter depends upon all
the facts and circumstances pertaining to that person's activities.
The prospectus also will state that dealers who are not
``underwriters'' but are participating in a distribution (as
contrasted to ordinary secondary market trading transactions), and
thus dealing with Shares that are part of an ``unsold allotment''
within the meaning of section 4(3)(C) of the Securities Act, would
be unable to take advantage of the prospectus delivery exemption
provided by section 4(3) of the Securities Act.
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    12. Applicants state that Shares are bought and sold in the
secondary market in the same manner as closed-end fund shares.
Applicants note that transactions in closed-end fund shares are not
subject to section 24(d), and thus closed-end fund shares are sold in
the secondary market without a prospectus. Applicants contend that
Shares likewise merit a reduction in the unnecessary compliance costs
and regulatory burdens resulting from the imposition of the prospectus
delivery obligations in the secondary market. Because Shares will be
listed on the American Stock Exchange, the New York Stock Exchange or
another national securities exchange as defined in section 2(a)(26) of
the Act (each, a ``Stock Exchange''), prospective investors will have
access to information about the product over and above what is normally
available about an open-end security. Applicants state that information
regarding market price and volume is available on a real time basis
throughout the day on brokers' computer screens and other electronic
services. The previous day's price and volume information is published
daily in the financial section of newspapers.

In addition, the ETFs' websites will include a downloadable form of the
prospectus for each ETF and additional quantitative information that is
updated on a daily basis, including daily trading volume, closing
price, the net asset value (``NAV'') for each ETF and information about
the premiums and discounts at which the Shares have traded.
    13. Applicants will arrange for broker-dealers selling Shares in
the secondary market to provide purchasers with a product description
(``Product Description'') that describes, in plain English, the
relevant Trust and the Shares it issues. Applicants state that a
Product Description is not intended to substitute for a full
prospectus. Applicants state that the Product Description will be
tailored to meet the information needs of investors purchasing Shares
in the secondary market.

Conditions to Prior Order

    14. Applicants also seek to amend the Prior Order by replacing
existing conditions 2, 5, and 6 to the Prior Order and adding a new
condition.. Existing condition 2 to the Prior Order currently provides
that each ETF's prospectus will clearly disclose that, for purposes of
the Act, shares are issued by the ETF and that the acquisition of
Shares by investment companies is subject to the restrictions of
section 12(d)(1) of the Act. In light of the requested order to permit
Investing Funds to invest in ETFs in excess of the limits of section
12(d)(1), applicants wish to replace this condition in the Prior Order
with condition 13, as stated below.
    15. Existing condition 5 to the Prior Order provides that the
website for each Trust, which will be publicly available at no charge,
will contain the following information, on a per Share basis, for each
ETF: (a) the prior business day's NAV and the reported closing price,
and a calculation of the premium or discount of such price against such
NAV; and (b) data in chart format displaying the frequency distribution
of discounts and premiums of the daily closing price against the NAV,
within appropriate ranges, for each of the four previous calendar
quarters.
    16. Existing condition 6 to the Prior Order provides that the
prospectus and annual report for each ETF will also include: (a) The
information listed in existing condition 5(b), (i) in the case of the
prospectus, for the most recently completed year (and the most recently
completed quarter or quarters as applicable) and (ii) in the case of
the annual report, for the immediately preceding five years, as
applicable; and (b) the following data, calculated on a per Share basis
for one, five and ten year periods (or life of the ETFs): (i) The
cumulative total return and the average annual total return based on
NAV and market price, and (ii) the cumulative total return of the
relevant Index.
    17. Conditions 14 and 15, as stated below, would replace conditions
5 and 6 to the Prior Order, respectively. Under the new conditions,
each ETF would use the mid-point of the bid/ask spread at the time of
calculation of its NAV (the ``Bid/Ask Price'') instead of the Shares''
closing price for certain aspects of the data presentation required by
the conditions.\12\
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    \12\ The Bid/Ask Price of an ETF is determined using the highest
bid and the lowest offer on the Stock Exchange as of the time of the
calculation of such ETF's NAV. The records relating to Bid/Ask
Prices will be retained by the ETFs and their service providers.
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Applicants' Conditions

    Applicants agree that any order of the Commission granting the
requested relief from sections 12(d)(1)(A) and (B) will be subject to
the following conditions:
    1. The members of the Investing Fund Adviser Group will not control
(individually or in the aggregate) an ETF within the meaning of section
2(a)(9) of the Act. The members of an Investing Fund Subadviser Group
will not control (individually or in the aggregate) an ETF within the
meaning of section 2(a)(9) of the Act. If, as a result of a decrease in
the outstanding voting securities of an ETF, the Investing Fund Adviser
Group or the Investing Fund Subadviser Group, each in the aggregate,
becomes a holder of more than 25 percent of the outstanding voting
securities of an ETF, it will vote its shares of the ETF in the same
proportion as the vote of all other holders of the ETF's shares. This
condition does not apply to the Investing Fund Subadviser Group with
respect to an ETF for which the Investing Fund Subadviser or a person
controlling, controlled by, or under common control with the Investing
Fund Subadviser acts as the investment adviser within the meaning of
section 2(a)(20)(A) of the Act (in the case of an Open-end ETF) or as
the sponsor (in the case of a UIT ETF).
    2. No Investing Fund or Investing Fund Affiliate will cause any
existing or potential investment by the Investing Fund in an ETF to
influence the terms of any services or transactions between the
Investing Fund or an Investing Fund Affiliate and the ETF or an ETF
Affiliate.
    3. The board of directors or trustees of an Investing Management
Company, including a majority of the disinterested directors or
trustees, will adopt procedures reasonably designed to assure that the
Investing Fund Adviser and any Investing Fund Subadviser are conducting
the investment program of the Investing Management Company without
taking into account any consideration received by the Investing
Management Company or an Investing Fund Affiliate from an ETF or an ETF
Affiliate in connection with any services or transactions.
    4. Once an investment by an Investing Fund in the securities of an
ETF exceeds the limits in section 12(d)(1)(A)(i) of the Act, the board
of directors/trustees of an Open-end ETF, including a majority of the
disinterested board members, will determine that any consideration paid
by an Open-end ETF to an Investing Fund or an Investing Fund Affiliate
in connection with any services or transactions: (i) Is fair and
reasonable in relation to the nature and quality of the services and
benefits received by the Open-end ETF; (ii) is within the range of
consideration that the Open-end ETF would be required to pay to another
unaffiliated entity in connection with the same services or
transactions; and (iii) does not involve overreaching on the part of
any person concerned. This condition does not apply with respect to any
services or transactions between an Open-end ETF and its investment
adviser(s), or any person controlling, controlled by or under common
control with such investment adviser(s).
    5. The Investing Fund Adviser, or Trustee or Sponsor of an
Investing Trust, will waive fees otherwise payable to it by the
Investing Management Company or Investing Trust, as applicable, in an
amount at least equal to any compensation (including fees received
pursuant to any plan adopted by an Open-end ETF under rule 12b-1 under
the Act) received from an ETF by the Investing Fund Adviser, Trustee or
Sponsor, or an affiliated person of the Investing Fund Adviser, Trustee
or Sponsor, other than any advisory fees paid to the Investing Fund
Adviser, Trustee or Sponsor, or its affiliated person by the ETF, in
connection with the investment by the Investing Management Company or
Investing Trust, as applicable, in the ETF. Any Investing Fund
Subadviser will waive fees otherwise payable to the Investing Fund
Subadviser, directly or indirectly, by the Investing Management Company
in an amount at least equal to any compensation received from an ETF by
the Investing Fund Subadviser, or an affiliated person of the Investing
Fund Subadviser, other than any advisory fees paid to the Investing
Fund Subadviser

or its affiliated person by the ETF, in connection with any investment
by the Investing Management Company in the ETF made at the direction of
the Investing Fund Subadviser. In the event that the Investing Fund
Subadviser waives fees, the benefit of the waiver will be passed
through to the Investing Management Company.
    6. No Investing Fund or Investing Fund Affiliate (except to the
extent it is acting in its capacity as an investment adviser to an
Open-end ETF or sponsor to a UIT ETF) will cause an ETF to purchase a
security in any Affiliated Underwriting.
    7. The board of an Open-end ETF, including a majority of the
disinterested board members, will adopt procedures reasonably designed
to monitor any purchases of securities by the Open-end ETF in an
Affiliated Underwriting, once an investment by an Investing Fund in the
securities of the Open-end ETF exceeds the limit of section
12(d)(1)(A)(i) of the Act, including any purchases made directly from
an Underwriting Affiliate. The board of the Open-end ETF will review
these purchases periodically, but no less frequently than annually, to
determine whether the purchases were influenced by the investment by
the Investing Fund in the Open-end ETF. The board of the Open-end ETF
will consider, among other things: (i) Whether the purchases were
consistent with the investment objectives and policies of the Open-end
ETF; (ii) how the performance of securities purchased in an Affiliated
Underwriting compares to the performance of comparable securities
purchased during a comparable period of time in underwritings other
than Affiliated Underwritings or to a benchmark such as a comparable
market index; and (iii) whether the amount of securities purchased by
the Open-ETF in Affiliated Underwritings and the amount purchased
directly from an Underwriting Affiliate have changed significantly from
prior years. The board of the Open-end ETF will take any appropriate
actions based on its review, including, if appropriate, the institution
of procedures designed to assure that purchases of securities in
Affiliated Underwritings are in the best interest of shareholders.
    8. Each Open-end ETF will maintain and preserve permanently in an
easily accessible place a written copy of the procedures described in
the preceding condition, and any modifications to such procedures, and
will maintain and preserve for a period of not less than six years from
the end of the fiscal year in which any purchase in an Affiliated
Underwriting occurred, the first two years in an easily accessible
place, a written record of each purchase of securities in Affiliated
Underwritings once an investment by an Investing Fund in the securities
of the Open-end ETF exceeds the limit of section 12(d)(1)(A)(i) of the
Act, setting forth from whom the securities were acquired, the identity
of the underwriting syndicate's members, the terms of the purchase, and
the information or materials upon which the determinations of the board
of the Open-end ETF were made.
    9. Before investing in an ETF in excess of the limit in section
12(d)(1)(A), each Investing Fund and the ETF will execute an agreement
stating, without limitation, that their boards of directors or trustees
and their investment adviser(s), or their sponsors or trustees, as
applicable, understand the terms and conditions of the order, and agree
to fulfill their responsibilities under the order. At the time of its
investment in shares of a Open-end ETF in excess of the limit in
section 12(d)(1)(A)(i), an Investing Fund will notify the Open-end ETF
of the investment. At such time, the Investing Fund will also transmit
to the Open-end ETF a list of the names of each Investing Fund
Affiliate and Underwriting Affiliate. The Investing Fund will notify
the Open-end ETF of any changes to the list of the names as soon as
reasonably practicable after a change occurs. The ETF and the Investing
Fund will maintain and preserve a copy of the order, the agreement,
and, in the case of an Open-end ETF, the list with any updated
information for the duration of the investment and for a period of not
less than six years thereafter, the first two years in an easily
accessible place.
    10. Before approving any advisory contract under section 15 of the
Act, the board of directors or trustees of each Investing Management
Company, including a majority of the independent directors or trustees,
will find that the advisory fees charged under such advisory contract
are based on services provided that will be in addition to, rather than
duplicative of, the services provided under the advisory contract(s) of
any Open-end ETF in which the Investing Management Company may invest.
These findings and their basis will be recorded fully in the minute
books of the appropriate Investing Management Company.
    11. Any sales charges and/or service fees charged with respect to
shares of an Investing Fund will not exceed the limits applicable to a
fund of funds as set forth in Conduct Rule 2830 of the NASD.
    12. No ETF will acquire securities of any investment company or
company relying on section 3(c)(1) or 3(c)(7) of the Act in excess of
the limits contained in section 12(d)(1)(A) of the Act.
    Applicants agree that conditions 2, 5 and 6 to the Prior Order,
respectively, will be replaced with the following conditions:
    13. Each ETF's prospectus and Product Description will clearly
disclose that, for purposes of the Act, Shares are issued by the ETF,
which is a registered investment company, and the acquisition of Shares
by investment companies is subject to the restrictions of section
12(d)(1) of the Act, except as permitted by an exemptive order that
permits registered investment companies to invest in an ETF beyond the
limits of section 12(d)(1), subject to certain terms and conditions,
including that the registered investment company enter into an
agreement with the ETF regarding the terms of the investment.
    14. The Web site for each ETF, which is and will be publicly
accessible at no charge, will contain the following information, on a
per Share basis, for each ETF: (a) The prior business day's NAV and the
Bid/Ask Price, and a calculation of the premium or discount of the Bid/
Ask Price against such NAV; and (b) data in chart format displaying the
frequency distribution of discounts and premiums of the daily Bid/Ask
Price against the NAV, within appropriate ranges, for each of the four
previous calendar quarters. In addition, the Product Description for
each ETF will state that the Web site for the ETF has information about
the premiums and discounts at which the ETF's Shares have traded.
    15. The prospectus and annual report for each ETF will also
include: (a) Data in chart format displaying the frequency distribution
of discounts and premiums of the daily Bid/Ask Price against the NAV,
within appropriate ranges, (i) in the case of the prospectus, for the
most recently completed year (and the most recently completed quarter
or quarters, as applicable) and (ii) in the case of the annual report,
for the immediately preceding five years, as applicable; and (b) the
following data, calculated on a per Share basis for one, five and ten
year periods (or life of the ETF): (i) The cumulative total return and
the average annual total return based on NAV and Bid/Ask Price, and
(ii) the cumulative total return of the relevant Index.
    Applicants agree to add the following condition to the Prior Order:
    16. Before an ETF may rely on the order, the Commission will have
approved, pursuant to rule 19b-4 under the Exchange Act, a Stock
Exchange rule

requiring Stock Exchange members and member organizations effecting
transactions in Shares of such ETF to deliver a Product Description to
purchasers of Shares.

    For the Commission, by the Division of Investment Management,
pursuant to delegated authority.
Jill M. Peterson,
Assistant Secretary.
 [FR Doc. E6-17060 Filed 10-13-06; 8:45 am]

BILLING CODE 8011-01-P


[Federal Register Volume 85, Number 202 (Monday, October 19, 2020)]
[Notices]
[Pages 66317-66318]
[FR Doc No: 2020-23060]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #1

October 13, 2020.
    Take notice that the Commission received the following electric
corporate filings:

    .Docket Numbers: EC21-7-000.
    Applicants: Sun Streams 2, LLC.
    Description: Application for Authorization Under Section 203 of the
Federal Power Act, et al. of Sun Streams 2, LLC.
    Filed Date: 10/9/20.
    Accession Number: 20201009-5191.
    Comments Due: 5 p.m. ET 10/30/20.

    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER11-47-012; ER12-1540-010; ER12-1541-010; ER12-
1542-010; ER12-1544-010; ER17-1930-004; ER17-1931-004; ER17-1932-004;
ER14-594-014; ER11-46-015; ER11-41-012; ER12-2343-010; ER13-1896-016;
ER16-323-008; ER17-2088-002; ER16-2035-002; ER20-2000-001; ER10-2596-
010; ER12-2200-006; ER12-1400-007; ER11-2029-007.
    Applicants: Appalachian Power Company, Indiana Michigan Power
Company, Kentucky Power Company, Kingsport Power Company, Wheeling
Power Company, Public Service Company of Oklahoma, AEP Texas Inc.,
Southwestern Electric Power Company, Ohio Power Company, AEP Energy
Partners, Inc., AEP Retail Energy Partners LLC, AEP Energy, Inc., AEP
Generation Resources Inc., Ohio Valley Electric Corporation, Apple
Blossom Wind, LLC, Black Oak Wind, LLC, Clyde Onsite Generation, LLC,
Flower Ridge II Wind Farm LLC, Mehoopany Wind Energy LLC, Flat Ridge 2
Wind LLC, Cedar Creek II, LLC.
    Description: Notice of Non-Material Change in Status of the AEP
Companies, et al.
    Filed Date: 10/9/20.
    Accession Number: 20201009-5187.
    Comments Due: 5 p.m. ET 10/30/20.

    Docket Numbers: ER19-460-006.
    Applicants: Southwest Power Pool, Inc.
    Description: Compliance filing: Order No. 841 Compliance Filing in
Response to July 2020 Order to be effective 8/5/2021.
    Filed Date: 10/13/20.
    Accession Number: 20201013-5144.
    Comments Due: 5 p.m. ET 11/3/20.

    Docket Numbers: ER19-469-004.
    Applicants: PJM Interconnection, L.L.C.
    Description: Compliance filing: Compliance Filing Pursuant to July
16, 2020 Order re Order No. 841 to be effective 12/3/2019.
    Filed Date: 10/13/20.
    Accession Number: 20201013-5174.
    Comments Due: 5 p.m. ET 11/3/20.

    Docket Numbers: ER19-1960-004.
    Applicants: Midcontinent Independent System Operator, Inc.
    Description: Compliance filing: 2020-10-13_Attachment X Additional
Compliance for Order 845 to be effective 12/20/2019.
    Filed Date: 10/13/20.
    Accession Number: 20201013-5328.
    Comments Due: 5 p.m. ET 11/3/20.

    Docket Numbers: ER19-2546-002.
    Applicants: Tuscola Wind II, LLC.
    Description: Compliance filing: Tuscola Wind II, LLC, Docket No.
ER19-2546 to be effective 10/1/2019.
    Filed Date: 10/13/20.
    Accession Number: 20201013-5155.
    Comments Due: 5 p.m. ET 11/3/20.

    Docket Numbers: ER20-1449-002.
    Applicants: Midcontinent Independent System Operator, Inc., Entergy
Services, LLC.
    Description: Tariff Amendment: 2020-10-13_Entergy NOL Amendment to
be effective 6/1/2020.
    Filed Date: 10/13/20.
    Accession Number: 20201013-5228.
    Comments Due: 5 p.m. ET 11/3/20.

    Docket Numbers: ER21-90-000.
    Applicants: Sun Streams 2, LLC.
    Description: Initial rate filing: Market-Based Rate Application to
be effective 12/9/2020.
    Filed Date: 10/9/20.
    Accession Number: 20201009-5171.
    Comments Due: 5 p.m. ET 10/30/20.

    Docket Numbers: ER21-91-000.
    Applicants: Nevada Power Company.
    Description: Sec.  205(d) Rate Filing: Service Agreement No. 20-
00014, NPC and Open Mountain to be effective 12/12/2020.
    Filed Date: 10/13/20.
    Accession Number: 20201013-5001.
    Comments Due: 5 p.m. ET 11/3/20.

    Docket Numbers: ER21-92-000.
    Applicants: Nevada Power Company.
    Description: Sec.  205(d) Rate Filing: Service Agreement No. 20-
00016 NPC and Open Mountain to be effective 12/12/2020.
    Filed Date: 10/13/20.
    Accession Number: 20201013-5002.
    Comments Due: 5 p.m. ET 11/3/20.

    Docket Numbers: ER21-93-000.
    Applicants: MidAmerican Energy Company.
    Description: Sec.  205(d) Rate Filing: First Amended and Restated
Facilities Agreement to be effective 9/22/2020.
    Filed Date: 10/13/20.
    Accession Number: 20201013-5003.
    Comments Due: 5 p.m. ET 11/3/20.

    Docket Numbers: ER21-94-000.
    Applicants: Tri-State Generation and Transmission Association, Inc.
    Description: Sec.  205(d) Rate Filing: Amendment to Tri-State Rate
Schedule No. 70 to be effective 10/14/2020.
    Filed Date: 10/13/20.

    Accession Number: 20201013-5175.
    Comments Due: 5 p.m. ET 11/3/20.

    Docket Numbers: ER21-95-000.
    Applicants: Citizens Sunrise Transmission LLC.
    Description: Sec.  205(d) Rate Filing: Annual TRBAA Filing October
2020 to be effective 1/1/2021.
    Filed Date: 10/13/20.
    Accession Number: 20201013-5176.
    Comments Due: 5 p.m. ET 11/3/20.

    Docket Numbers: ER21-96-000.
    Applicants: Citizens Sycamore-Penasquitos Transmission LLC.
    Description: Sec.  205(d) Rate Filing: Annual TRBAA Filing October
2020 to be effective 1/1/2021.
    Filed Date: 10/13/20.
    Accession Number: 20201013-5178.
    Comments Due: 5 p.m. ET 11/3/20.

    Docket Numbers: ER21-97-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: Original ISA, Service
Agreement No. 5796; Queue No. AC2-112 to be effective 9/10/2020.
    Filed Date: 10/13/20.
    Accession Number: 20201013-5191.
    Comments Due: 5 p.m. ET 11/3/20.

    The filings are accessible in the Commission's eLibrary system
(https://elibrary.ferc.gov/idmws/search/fercgensearch.asp) by querying
the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: October 13, 2020.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2020-23060 Filed 10-16-20; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 82, Number 198 (Monday, October 16, 2017)]
[Rules and Regulations]
[Pages 47967-47969]
[FR Doc No: 2017-22305]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 866

[Docket No. FDA-2017-N-5714]

Medical Devices; Immunology and Microbiology Devices;
Classification of the Automated Image Assessment System for Microbial
Colonies on Solid Culture Media

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

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

SUMMARY: The Food and Drug Administration (FDA or we) is classifying
the automated image assessment system for microbial colonies on solid
culture media into class II (special controls). The special controls
that apply to the device type are identified in this order and will be
part of the codified language for the automated image assessment system
for microbial colonies on solid culture media's classification. We are
taking this action because we have determined that classifying the
device into class II (special controls) will provide a reasonable
assurance of safety and effectiveness of the device. We believe this
action will also enhance patients' access to beneficial innovative
devices, in part by reducing regulatory burdens.

DATES: This order is effective October 16, 2017. The classification was
applicable on October 6, 2016.

FOR FURTHER INFORMATION CONTACT: Steven Tjoe, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 4550, Silver Spring, MD 20993-0002,<PHONE_NUMBER>
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    Upon request, FDA has classified the automated image assessment
system for microbial colonies on solid culture media as class II
(special controls), which we have determined will provide a reasonable
assurance of safety and effectiveness. In addition, we believe this
action will enhance patients' access to beneficial innovation, in part
by reducing regulatory burdens by placing the device into a lower
device class than the automatic class III assignment.
    The automatic assignment of class III occurs by operation of law
and without any action by FDA, regardless of the level of risk posed by
the new device. Any device that was not in commercial

distribution before May 28, 1976, is automatically classified as, and
remains within, class III and requires premarket approval unless and
until FDA takes an action to classify or reclassify the device (see 21
U.S.C. 360c(f)(1)). We refer to these devices as ``postamendments
devices'' because they were not in commercial distribution prior to the
date of enactment of the Medical Device Amendments of 1976, which
amended the Federal Food, Drug, and Cosmetic Act (the FD&C Act).
    FDA may take a variety of actions in appropriate circumstances to
classify or reclassify a device into class I or II. We may issue an
order finding a new device to be substantially equivalent under section
513(i) of the FD&C Act to a predicate device that does not require
premarket approval (see 21 U.S.C. 360c(i)). We determine whether a new
device is substantially equivalent to a predicate by means of the
procedures for premarket notification under section 510(k) of the FD&C
Act and part 807 (21 U.S.C. 360(k) and 21 CFR part 807, respectively).
    FDA may also classify a device through ``De Novo'' classification,
a common name for the process authorized under section 513(f)(2) of the
FD&C Act. Section 207 of the Food and Drug Administration Modernization
Act of 1997 established the first procedure for De Novo classification
(Pub. L. 105-115). Section 607 of the Food and Drug Administration
Safety and Innovation Act modified the De Novo application process by
adding a second procedure (Pub. L. 112-144). A device sponsor may
utilize either procedure for De Novo classification.
    Under the first procedure, the person submits a 510(k) for a device
that has not previously been classified. After receiving an order from
FDA classifying the device into class III under section 513(f)(1) of
the FD&C Act, the person then requests a classification under section
513(f)(2).
    Under the second procedure, rather than first submitting a 510(k)
and then a request for classification, if the person determines that
there is no legally marketed device upon which to base a determination
of substantial equivalence, that person requests a classification under
section 513(f)(2) of the FD&C Act.
    Under either procedure for De Novo classification, FDA shall
classify the device by written order within 120 days. The
classification will be according to the criteria under section
513(a)(1) of the FD&C Act. Although the device was automatically placed
within class III, the De Novo classification is considered to be the
initial classification of the device.
    We believe this De Novo classification will enhance patients'
access to beneficial innovation, in part by reducing regulatory
burdens. When FDA classifies a device into class I or II via the De
Novo process, the device can serve as a predicate for future devices of
that type, including for 510(k)s (see 21 U.S.C. 360c(f)(2)(B)(i)). As a
result, other device sponsors do not have to submit a De Novo request
or premarket approval application in order to market a substantially
equivalent device (see 21 U.S.C. 360c(i), defining ``substantial
equivalence''). Instead, sponsors can use the less-burdensome 510(k)
process, when necessary, to market their device.

II. De Novo Classification

    On December 24, 2015, Clever Culture Systems AG submitted a request
for De Novo classification of the APAS Compact. FDA reviewed the
request in order to classify the device under the criteria for
classification set forth in section 513(a)(1) of the FD&C Act. We
classify devices into class II if general controls by themselves are
insufficient to provide reasonable assurance of safety and
effectiveness, but there is sufficient information to establish special
controls that, in combination with the general controls, provide
reasonable assurance of the safety and effectiveness of the device for
its intended use (see 21 U.S.C. 360c(a)(1)(B)). After review of the
information submitted in the request, we determined that the device can
be classified into class II with the establishment of special controls.
FDA has determined that these special controls, in addition to general
controls, will provide reasonable assurance of the safety and
effectiveness of the device.
    Therefore, on October 6, 2016, FDA issued an order to the requestor
classifying the device into class II. FDA is codifying the
classification of the device by adding 21 CFR 866.2190. We have named
the generic type of device automated image assessment system for
microbial colonies on solid culture media, and it is identified as a
system that is intended to assess the presence or absence of microbial
colonies on solid microbiological culture medium, and to interpret
their number, and phenotypic and morphologic characteristics through
analysis of two dimensional digital images as an aid in diagnosis of
infectious disease.
    FDA has identified the following risks to health associated
specifically with this type of device and the measures required to
mitigate these risks in table 1.

  Table 1--Automated Image Assessment System for Microbial Colonies on Solid Culture Media Risks and Mitigation
                                                    Measures
----------------------------------------------------------------------------------------------------------------
                         Identified risks                                Mitigation measures/21 CFR section
----------------------------------------------------------------------------------------------------------------
False positive results (i.e., incorrect designation of plates for  General controls and special controls: (1),
 ``Review'' or as ``Positive'').                                    (2), (3), (4), (5), (6), (7) (21 CFR
                                                                    866.2190(b)(1); 21 CFR 866.2190(b)(2); 21
                                                                    CFR 866.2190(b)(3); 21 CFR 866.2190(b)(4);
                                                                    21 CFR 866.2190(b)(5); 21 CFR
                                                                    866.2190(b)(6); and 21 CFR 866.2190(b)(7)).
False negative results (i.e., failure to detect growth and         General controls and special controls: (1),
 incorrect designation of plates as ``Negative'').                  (2), (3), (4), (5), (6), (7) (21 CFR
                                                                    866.2190(b)(1); 21 CFR 866.2190(b)(2); 21
                                                                    CFR 866.2190(b)(3); 21 CFR 866.2190(b)(4);
                                                                    21 CFR 866.2190(b)(5); 21 CFR
                                                                    866.2190(b)(6); and 21 CFR 866.2190(b)(7)).
----------------------------------------------------------------------------------------------------------------

    FDA has determined that special controls, in combination with the
general controls, address these risks to health and provide reasonable
assurance of safety and effectiveness. In order for a device to fall
within this classification, and thus avoid automatic classification in
class III, it would have to comply with the special controls named in
this final order. The necessary special controls appear in the
regulation codified by this order. This device is subject to premarket
notification requirements under section 510(k) of the FD&C Act.

III. Analysis of Environmental Impact

    The Agency has determined under 21 CFR 25.34(b) that this action is
of a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment

nor an environmental impact statement is required.

IV. Paperwork Reduction Act of 1995

    This final order establishes special controls that refer to
previously approved collections of information found in other FDA
regulations. These collections of information are subject to review by
the Office of Management and Budget (OMB) under the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501-3520). The collections of information in
part 807, subpart E, regarding premarket notification submissions have
been approved under OMB control number 0910-0120, the collections of
information in part 820 have been approved under OMB control number
0910-0073, and the collections of information in 21 CFR parts 801 and
809, regarding labeling have been approved under OMB control number
0910-0485.

List of Subjects in 21 CFR Part 866

    Biologics, Laboratories, Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
866 is amended as follows:

PART 866--IMMUNOLOGY AND MICROBIOLOGY DEVICES

0
1. The authority citation for part 866 continues to read as follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

0
2. Add Sec.  866.2190 to subpart C to read as follows:

Sec.  866.2190  Automated image assessment system for microbial
colonies on solid culture media.

    (a) Identification. An automated image assessment system for
microbial colonies on solid culture media is a system that is intended
to assess the presence or absence of microbial colonies on solid
microbiological culture medium, and to interpret their number, and
phenotypic and morphologic characteristics through analysis of two
dimensional digital images as an aid in diagnosis of infectious
disease.
    (b) Classification. Class II (special controls). The special
controls for this device are:
    (1) Premarket notification submissions must include a detailed
description of the device, including the technology employed,
components and software modules, as well as a detailed explanation of
the result algorithms and any expert rules that are used to assess
colony characteristics and enumerate colonies from image capture
through end result.
    (2) Premarket notification submissions must include detailed
documentation of the analytical studies performed to characterize
device performance to support the intended use, as appropriate.
    (3) Premarket notification submissions must include detailed
documentation from clinical studies performed on a population that is
consistent with the intended use population.
    (i) The clinical studies must establish the device performance
based on comparison to results obtained by an acceptable reference
method, as appropriate.
    (ii) The clinical study documentation must include the study
protocol with a predefined statistical analysis plan and the final
report documenting support for the Indications for Use and the results
of the statistical analysis, as appropriate.
    (4) Premarket notification submissions must include detailed
documentation for device software, including but not limited to
software applications and hardware based components that incorporate
software, and any decision-making thresholds used to generate results
for the device. If a part of a Total Laboratory Automation System, the
premarket notification submission must include detailed documentation
addressing the instrument and software system integration.
    (5) Premarket notification submissions must include detailed
documentation of appropriate instructions for use regarding the
intended user's device quality control procedures for the instrument
system and components, as appropriate.
    (6) The 21 CFR 809.10 compliant device labeling must include:
    (i) Detailed user instructions to mitigate the risk of failure to
operate the instrument correctly.
    (ii) A detailed explanation of the interpretation of results and
limitations regarding the need for review of culture plates by a
qualified microbiologist, as appropriate.
    (iii) A summary of performance data obtained from the analytical
studies used to support device performance, as appropriate.
    (iv) A summary of performance data obtained from clinical studies
performed on a population that is consistent with the intended use
population, as appropriate.
    (7) Under 21 CFR 820.30 compliant design control, device
manufacturers must, as appropriate:
    (i) Conduct human factors/usability validation testing with the
final version of the labeling and related materials to adequately
mitigate the risk of failure to operate the instrument correctly.
    (ii) Document a device training program that will be offered to the
end user to adequately mitigate the risk of failure to operate the
instrument correctly.

    Dated: October 11, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-22305 Filed 10-13-17; 8:45 am]
BILLING CODE 4164-01-P


maintenance plan required under Sec.  141.804.
    (4) All events requiring notification to passengers or crew, or
non-routine disinfection and flushing, or non-routine sampling, within
10 days of the event (e.g., notification of positive sample result by
laboratory), including information on whether required notification was
provided to passengers or crew or both.
    (5) Failure to comply with the monitoring or disinfection and
flushing requirements of this subpart within 10 calendar days of
discovery of the failure.
    (6) Changes in disinfection and flushing and coliform sampling
frequencies no later than 10 days following the calendar month in which
the change occurred. Changes to an aircraft's routine coliform sampling
frequency and routine disinfection and flushing frequency must be
included in the aircraft water system operation and maintenance plan
that is included in the air carrier operations and maintenance program
accepted by FAA in accordance with Sec.  141.804.
    (c) The air carrier must provide evidence of a self-inspection to
the Administrator within 90 days of completion of the self-inspection
required under Sec.  141.808(b), including reporting whether all
deficiencies were addressed in accordance with Sec.  141.808(c). The
air carrier must also report to the Administrator within 90 days that
any deficiency identified during a compliance audit conducted in
accordance with Sec.  141.808(a) has been addressed. If any deficiency
has not been addressed within 90 days of identification of the
deficiency, the report must also include a description of the
deficiency, an explanation as to why it has not yet been addressed, and
a schedule for addressing it as expeditiously as possible.
    (d) All information required to be reported to the Administrator
under this subpart must be in an electronic format established or
approved by the Administrator. If an air carrier is unable to report
electronically, the air carrier may use an alternative approach that
the Administrator approves.

Sec.  141.807  Recordkeeping requirements.

    (a) The air carrier must keep records of bacteriological analyses
for at least 5 years and must include the following information:

    (1) The date, time, and place of sampling, and the name of the
person who collected the sample;
    (2) Identification of the sample as a routine, repeat, follow-up,
or other special purpose sample;
    (3) Date of the analysis;
    (4) Laboratory and person responsible for performing the analysis;
    (5) The analytical technique/method used; and
    (6) The results of the analysis.
    (b) The air carrier must keep records of any disinfection and
flushing for at least 5 years and must include the following
information:
    (1) The date and time of the disinfection and flushing; and
    (2) The type of disinfection and flushing (i.e., routine or
corrective action).
    (c) The air carrier must keep records of a self-inspection for at
least 10 years and must include the following information:
    (1) The completion date of the self-inspection; and
    (2) Copies of any written reports, summaries, or communications
related to the self-inspection.
    (d) The air carrier must maintain sampling plans and make such
plans available for review by the Administrator upon request, including
during compliance audits.
    (e) The air carrier must maintain aircraft water system operations
and maintenance plans in accordance with FAA requirements, and make
such plans available for review by the Administrator upon request,
including during compliance audits.
    (f) The air carrier must keep copies of public notices to
passengers and crew issued as required by this subpart for at least 3
years after issuance.

Sec.  141.808  Audits and inspections.

    (a) The Administrator may conduct routine compliance audits as
deemed necessary in providing regulatory oversight to ensure proper
implementation of the requirements in this subpart. Compliance audits
may include, but are not limited to:
    (1) Bacteriological sampling of aircraft water system;
    (2) Reviews and audits of records as they pertain to water system
operations and maintenance such as log entries, disinfection and
flushing procedures, and sampling results; and
    (3) Observation of procedures involving the handling of finished
water, watering point selection, boarding of water, operation,
disinfection and flushing, and general maintenance and self-inspections
of aircraft water system.
    (b) Air carriers or their representatives must perform a self-
inspection of all water system components for each aircraft water
system no less frequently than once every 5 years.
    (c) The air carrier must address any deficiency identified during
compliance audits or routine self-inspections within 90 days of
identification of the deficiency, or where such deficiency is
identified during extended or heavy maintenance, before the aircraft is
put back into service. This includes any deficiency in the water
system's design, construction, operation, maintenance, or
administration, as well as any failure or malfunction of any system
component that has the potential to cause an unacceptable risk to
health or that could affect the reliable delivery of safe drinking
water.

Sec.  141.809  Supplemental treatment.

    (a) Any supplemental drinking water treatment units installed
onboard existing or new aircraft must be acceptable to FAA and FDA; and
must be installed, operated, and maintained in accordance with the
manufacturer's plans and specifications and FAA requirements.
    (b) Water supplemental treatment and production equipment must
produce water that meets the standards prescribed in this part.

Sec.  141.810  Violations.

    An air carrier is in violation of this subpart when, for any
aircraft water system it owns or operates, any of the following occur:
    (a) It fails to perform any of the requirements in accordance with
Sec.  141.803 or Sec.  141.804.
    (b) It has an E. coli-positive sample in any monitoring period
(routine and repeat samples are used in this determination).
    (c) It fails to provide notification to passengers and crew in
accordance with Sec.  141.805.
    (d) It fails to comply with the reporting and recordkeeping
requirements of this subpart.
    (e) It fails to conduct a self-inspection or address a deficiency
in accordance with Sec.  141.808.
    (f) It fails to develop a coliform sampling plan in accordance with
Sec.  141.802, or fails to have and follow an operations and
maintenance plan, which is included in a FAA accepted program in
accordance with Sec.  141.804.
[FR Doc. E9-24552 Filed 10-16-09; 8:45 am]

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[Federal Register Volume 79, Number 76 (Monday, April 21, 2014)]
[Notices]
[Pages 22177-22178]
[FR Doc No: 2014-09027]

=======================================================================
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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Notice of Intent To Prepare an Environmental Assessment (EA) for
the Proposed Part 139 Operating Certificate and Related Actions at
Paulding Northwest Atlanta Airport

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of Intent to prepare an Environmental Assessment and
notice of opportunity for public comment.

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

SUMMARY: The Federal Aviation Administration (FAA) is announcing its
intent to prepare an Environmental Assessment (EA) pursuant to the
National Environmental Policy Act (NEPA) of 1969 and its implementing
regulations for the application by Paulding County Airport Authority
(PCAA) for certification of Paulding Northwest Atlanta Airport (PUJ)
under 14 Code of Federal Regulations Part 139. The EA will also address
connected actions related to the introduction of scheduled commercial
air carrier service at PUJ. The purpose of the EA is to consider and
evaluate the potential environmental impacts of the proposed actions
and alternatives, including the no-action alternative.

DATES: FAA invites comments on the contents of EA during a 30-day
comment period that will be initiated upon publication of this Notice.
Please submit any written comments you may have on the content of the
EA May 21, 2014.

ADDRESSES: Please submit any written comments you may have on the
content of the EA to Atlanta Airports District Office, Attn: Lisa
Favors, Env. Program Manager, 1701 Columbia Ave., Suite 2-260, Atlanta,
GA 30337-2747. Comments may also be submitted by email to
<EMAIL_ADDRESS>
FOR FURTHER INFORMATION CONTACT: Lisa Favors, Environmental Program
Manager, Atlanta Airports District Office, 1701 Columbia Ave., Suite 2-
260, Atlanta, GA 30337-2747,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Paulding Northwest Atlanta Airport (PUJ or
airport) is located outside Atlanta, Georgia in the town of Dallas,
Georgia. It is owned by Paulding County and the PCAA and operated by
PCAA. It is designated as a general aviation airport. In 2013, the PCAA
submitted an application to the FAA requesting a Part 139 Operating
Certificate. A Part 139 Operating Certificate allows the airport to
accommodate scheduled passenger-carrying operations, frequently
referred to as ``commercial service.'' The FAA plans to prepare an EA
in accordance with FAA Order 1050.1E, Policies and Procedures for
Considering Environmental Impacts and FAA Order 5050.4B, National
Environmental Policy Act Implementing Instructions For Airport Actions.
    It is anticipated that the EA will consider the potential
environmental impacts associated with the following

proposed actions, and alternatives including the no-action alternative,
at PUJ: (1) Obtain an Airport Operating Certificate from FAA, as
required for commercial service under 14 CFR Part 139; (2) Relocate the
Runway 13 threshold 500 feet west, to the end of the existing concrete
pavement, which would increase the usable runway length from 5,505 feet
to 6,005 feet; (3) Relocate the Runway 13 Precision Approach Path
Indicators (PAPIs) by approximately 500 feet from their current
location, to accommodate the threshold relocation; (4) Re-mark the
runway and modify the runway lighting and electrical system to coincide
with the new threshold location; (5) Extend the parallel taxiway 500
feet west, to connect with the end of the existing runway pavement; (6)
Install approximately 19,000 linear feet of wildlife fencing around the
perimeter of the Airport; (7) Construct an Aircraft Rescue and Fire
Fighting (ARFF) facility adjacent to Airport Parkway, in conjunction
with the construction by Paulding County of an Airport Fire Station/
Emergency 911 Call Center; (8) Provide a mobile Air Traffic Control
Tower in the existing terminal area; (9) Obtain FAA redesignation of
airspace (to Class D) during periods when mobile Air Traffic Control
Tower is in operation; (10) Construct corporate hangars in the existing
terminal area; (11) Construct a terminal area expansion to provide
hangars and apron area; (12) Design and construct a 400-foot extension
of the Runway Safety Area (RSA) at the Runway 31 End to provide a 1,000
feet long by 500 feet wide RSA; (13) Design and install an approach
lighting system consisting of a Medium-Intensity Approach Lighting
System with Sequenced Flashers (MALSF) and towers; (14) Design paving
and marking for a corporate hangar area expansion; (15) Design paving
and marking for an itinerant parking area expansion; (16) Design paving
and marking for a T-hangar tie-down area expansion; (17) Construct a
blast pad on new pavement at the Runway 13 End; (18) Widen Runway 13-31
from 100 feet to 150 feet; (19) Provide temporary vehicle parking; and
(20) Acquire land interest for approximately two (2) acres of property
within the future Runway Protection Zone (RPZ) located west of the
Runway 13 End.
    In addition, the EA will consider the cumulative impacts of airport
improvement projects recently completed at PUJ including a runway
safety area expansion project and a taxiway widening and lighting
project. The EA will also consider the environmental impacts of the
introduction of scheduled commercial air carrier service to PUJ based
on an air traffic forecast. In addition, or in the alternative to the
forecast, the EA may consider a request by one or more commercial
service air carrier(s) to amend its operating specifications to allow
operation at PUJ. The EA will also consider the environmental impacts
of similar actions not connected to the introduction of scheduled
commercial air carrier service at PUJ but expected to occur at PUJ
around the same time as the connected actions.
    If, during preparation of the EA, it is determined that the
proposed project would result in significant environmental impacts that
cannot be mitigated, the FAA will issue a revised Notice of Intent
(NOI) to complete the NEPA process using an Environmental Impact
Statement (EIS).
    The FAA is now inviting the public, agencies, tribal governments,
and other interested parties to provide comments, suggestions, and
input on the content of the EA. The FAA requests that comments be as
specific as possible. The FAA will not provide responses to those
submitting comments at this time, but all timely comments will be
considered and included in the public record. Additional comments will
be solicited on a draft EA, and at least one public meeting held in
Paulding County, upon completion of the draft EA.

    Issued in Atlanta, Georgia, on April 15, 2014.
Larry F. Clark,
Manager, Atlanta Airports District Office, Southern Region.
[FR Doc. 2014-09027 Filed 4-18-14; 8:45 am]
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[Federal Register Volume 78, Number 66 (Friday, April 5, 2013)]
[Notices]
[Pages 20665-20666]
[FR Doc No: 2013-07948]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0012]

Pediatric Device Consortia Grant Program

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of grant funds for the support of the Office of Orphan
Products Development (OOPD) Pediatric Device Consortia (PDC) Grant
Program. The goal of the PDC Grant Program is to facilitate the
development, production, and distribution of pediatric medical devices.
The PDC will provide grants to nonprofit consortia which provide expert
advising and support services to innovators of pediatric devices. These
services should include business and regulatory consulting as well as
device testing capabilities. This program is intended to further the
development of multiple pediatric devices; thus, grants are not awarded
to support the development of a single device project.
    Although administered by the OOPD, this grant program is intended
to encompass devices that could be used in all pediatric conditions and
diseases, not just rare diseases. The pediatric population (neonates,
infants, children, and adolescents) includes patients who are 21 years
of age or younger at the time of diagnosis or treatment.

DATES: Important dates are as follows:
    1. The application due date is June 1, 2013.
    2. The anticipated start date is September, 2013.
    3. The opening date is May 1, 2013.
    4. The expiration date is June 2, 2013.

ADDRESSES: Submit the paper application to: Vieda Hubbard, Grants
Management (HFA-500), 5630 Fishers Lane, Rm. 2034, Rockville, MD 20857.
For more information, see section III of the SUPPLEMENTARY INFORMATION
section of this notice.

FOR FURTHER INFORMATION CONTACT:

Linda C. Ulrich, Director, Pediatric Device Consortia Grants Program,
Food and Drug Administration, Bldg. 32, Rm. 5271, 10903 New Hampshire
Ave., Silver Spring, MD 20993-0002,<PHONE_NUMBER>; or
Vieda Hubbard, Grants Management Specialist, Office of Acquisitions &
Grant Services, Food and Drug Administration, 5630 Fishers Lane, Rm.
2034, Rockville, MD 20857,<PHONE_NUMBER>.

    For more information on this funding opportunity announcement (FOA)
and to obtain detailed requirements, please refer to the full FOA
located at http://grants.nih.gov/grants/guide/ or http://www.fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/default.htm.

SUPPLEMENTARY INFORMATION:

I. Funding Opportunity Description

RFA-FD-13-010
93.103

A. Background

    The development of pediatric medical devices currently lags behind
the development of devices for adults. Pediatric patients often differ
from adults in terms of their size, growth, development, body
chemistry, and disease propensity, adding to the challenges of
pediatric device development. There currently exists a great need for
pediatric medical devices, including devices designed originally for
pediatric patients as well as existing adult devices adapted for
pediatric use. Recent passage of the Food and Drug Administration
Safety and Improvement Act (FDASIA) (Pub. L. 112-144) reauthorized
support of section 305 of the Pediatric Medical Device Safety and
Improvement Act of 2007 (Pub. L. 110-85), which requires HHS to provide
demonstration grants to nonprofit consortia to promote pediatric device
development. While the consortia themselves are nonprofit entities,
their contacts and membership can include for-profit partners.

B. Research Objectives

    The Pediatric Device Consortia Grant Program aims to fund networks
of pediatric medical device advisors who are able to provide a platform
of experienced regulatory, business planning, and device development
services (such as intellectual property advising; prototyping;
engineering; laboratory and animal testing; grant writing; and clinical
trial design) to help foster and guide the advancement of medical
devices for pediatric patients. A successful PDC brings together
individuals and institutions that can support pediatric medical device
progression through all stages of development--concept formation,
prototyping, preclinical, clinical, manufacturing, marketing, and
commercialization. The consortia are expected to support a mix of
projects at all stages of development, particularly the later stages of
clinical, manufacturing, and marketing.

    Specifically, the consortia will facilitate the development,
production, and distribution of pediatric medical devices by: (1)
Encouraging innovation and connecting qualified individuals with
pediatric device ideas with potential manufacturers; (2) mentoring and
managing pediatric device projects through the development process,
including product identification, prototype design, device development,
and marketing; (3) connecting innovators and physicians to existing
Federal and non-Federal resources; (4) assessing the scientific and
medical merit of proposed pediatric device projects; and (5) providing
assistance and advice as needed on business development, personnel
training, prototype development, and post-marketing needs.

C. Eligibility Information

    The grants are available to any domestic, public or private,
nonprofit entity (including State and local units of government).
Federal agencies that are not part of HHS may apply. Agencies that are
part of HHS may not apply. Organizations that engage in lobbying
activities, as described in section 501(c)(4) of the Internal Revenue
Code of 1968, are not eligible to receive grant awards.

II. Award Information/Funds Available

A. Award Amount

    The estimated amount of funds available for support of four to five
consortia awarded as a result of this announcement is $3 million for
fiscal year 2013. Because the nature and scope of the proposed research
will vary from application to application, it is anticipated that the
size and duration of each award will also vary. Although PDC financial
plans include support for this program, awards pursuant to this funding
opportunity are contingent upon the availability of funds and the
receipt of a sufficient number of meritorious applications.

B. Length of Support

    Grants will be awarded on a competitive basis up to $750,000 in
total (direct plus indirect) costs per year for up to 5 years,
contingent upon favorable annual review and an additional mid-cycle
review after 2\1/2\ years of funding.

III. Paper Application, Registration, and Submission Information

    To submit a paper application in response to this FOA, applicants
should first review the full announcement located at http://grants.nih.gov/grants/guide/ or http://www.fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/default.htm. (FDA has
verified the Web site addresses throughout this document, but FDA is
not responsible for any subsequent changes to the Web sites after this
document publishes in the Federal Register.) Persons interested in
applying for a grant may obtain an application at http://grants.nih.gov/grants/forms.htm. For all paper application submissions,
the following steps are required:
     Step 1: Obtain a Dun and Bradstreet (DUNS) Number.
     Step 2: Register With System for Award Management.
    Steps 1 and 2, in detail, can be found at http://www07.grants.gov/applicants/organization_registration.jsp. After you have followed
these steps, submit paper applications to: Vieda Hubbard, Grants
Management Specialist, Office of Acquisitions & Grant Services, 5630
Fishers Lane, Rm. 2034, Rockville, MD 20857, phone:<PHONE_NUMBER>.

    Dated: April 2, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-07948 Filed 4-4-13; 8:45 am]
BILLING CODE 4160-01-P


U.S. EPA. EPA-452/P-09-001. February 2009. Available at: https://nepis.epa.gov/Exe/ZyPURL.cgi?Dockey=P100FLUX.txt.
U.S. EPA. (2009c). Integrated Science Assessment for Particulate
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U.S. EPA. (2010a). Quantitative Health Risk Assessment for
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U.S. EPA. (2010b). Particulate Matter Urban-Focused Visibility
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List of Subjects in 40 CFR Part 50

    Environmental protection, Air pollution control, Carbon monoxide,
Lead, Nitrogen dioxide, Ozone, Particulate matter, Sulfur oxides.

    Dated: December 4, 2020.
Andrew Wheeler,
Administrator.
[FR Doc. 2020-27125 Filed 12-17-20; 8:45 am]
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