[Federal Register Volume 79, Number 41 (Monday, March 3, 2014)]
[Notices]
[Pages 11837-11840]
[FR Doc No: 2014-04555]

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SECURITIES AND EXCHANGE COMMISSION

[Investment Company Act Release No. 30923; File No. 812-14127]

Legg Mason Partners Equity Trust, et al.; Notice of Application

February 24, 2014.
AGENCY: Securities and Exchange Commission (``Commission'').

ACTION: Notice of an application under section 6(c) of the Investment
Company Act of 1940 (``Act'') for an exemption from section 15(a) of
the Act and rule 18f-2 under the Act, as well as from certain
disclosure requirements.

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SUMMARY: Summary of Application: Applicants request an order that would
permit them to enter into, and amend, subadvisory agreements with
Wholly-Owned Sub-Advisors (as defined below) and Non-Affiliated Sub-
Advisors (as defined below) without shareholder approval. The order
would also grant relief from certain disclosure requirements.
    Applicants: Legg Mason Partners Equity Trust (``Equity Trust''),
Legg Mason Partners Variable Equity Trust (``Variable Equity Trust,''
and, together with Equity Trust, the ``Trusts''), and Permal Asset
Management LLC (``Permal'').
    DATES: Filing Dates: The application was filed on March 1, 2013,
and amended on September 24, 2013, and February 6, 2014.
    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 March 21, 2014, 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: Trusts, 620 Eighth
Avenue, New York, NY 10018; Permal, 900 3rd Avenue, New York, NY 10022.

FOR FURTHER INFORMATION CONTACT: Courtney S. Thornton, Senior Counsel,
at<PHONE_NUMBER>, or David P. Bartels, Branch Chief, at<PHONE_NUMBER>
(Division of Investment Management, Chief Counsel's Office).

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

Applicants' Representations

    1. Each Trust is organized as a Maryland statutory trust and is
registered with the Commission as an open-end management investment
company under the Act. The Equity Trust currently consists of 39 series
of shares (each a ``Series'' and collectively, ``Series''), each with
its own distinct investment objectives, policies and restrictions. The
Variable Equity Trust consists of 14 Series, each with its own distinct
investment objectives, policies and restrictions. The Trusts may offer
additional Series that in the future may operate under the multi-
manager structure described in the application and comply with the
terms and conditions set forth therein.
    2. Permal is a limited liability company organized under the laws
of the State of Delaware and is registered

with the Commission as an investment adviser under the Investment
Advisers Act of 1940 (``Advisers Act'').
    3. Applicants request an order to permit the Advisor,\1\ subject to
the approval of the applicable board of trustees (``Board''), including
a majority of the members of the Board who are not ``interested
persons'', as defined in section 2(a)(19) of the Act, of the Series or
the Advisor (``Independent Board Members''), to, without obtaining
shareholder approval: (i) select Sub-Advisors \2\ to manage all or a
portion of the assets of a Series and enter into Sub-Advisory
Agreements (as defined below) with the Sub-Advisors, and (ii)
materially amend Sub-Advisory Agreements with the Sub-Advisors.\3\
Applicants request that the relief apply to the applicants, as well as
to any future Series and any other existing or future registered open-
end management investment company or series thereof that is advised by
an Advisor, uses the multi-manager structure described in the
application, and complies with the terms and conditions of the
application (each a ``Subadvised Series'').\4\ The requested relief
will not extend to any sub-advisor, other than a Wholly-Owned Sub-
Advisor, who is an affiliated person, as defined in section 2(a)(3) of
the Act, of the Subadvised Series or of the Advisor, other than by
reason of serving as sub-advisor to one or more of the Subadvised
Series (``Affiliated Sub-Advisor'').
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    \1\ The term ``Advisor'' includes (i) Permal and (ii) any entity
controlling, controlled by or under common control with, the Permal
or its successors. For purposes of the requested order,
``successor'' is limited to an entity that results from a
reorganization into another jurisdiction or a change in the type of
business organization. Each Advisor will be registered with the
Commission under the Advisers Act.
    \2\ As used herein, a ``Sub-Advisor'' is (1) an indirect or
direct ``wholly-owned subsidiary'' (as such term is defined in the
Act) of the Advisor for that Series, or (2) a sister company of the
Advisor for that Series that is an indirect or direct wholly-owned
subsidiary of the same company that, indirectly or directly, wholly
owns the Advisor (each of (1) and (2) a ``Wholly-Owned Sub-
Advisor''), or (3) not an ``affiliated person'' (as defined in
section 2(a)(3) of the Act) of the Series, the applicable Trust, or
the Advisor, except to the extent that an affiliation arises solely
because the Sub-Advisor serves as a Sub-Advisor to a Subadvised
Series (each a ``Non-Affiliated Sub-Advisor). Each Sub-Advisor will
be registered under Advisers Act or exempt from registration.
    \3\ Shareholder approval will continue to be required for any
other Sub-Advisor change not otherwise permitted by rule or other
action of the Commission or staff and material amendments to an
existing Sub-Advisory Agreement with any sub-advisor other than a
Non-Affiliated Sub-Advisor or a Wholly-Owned Sub-Advisor (all such
changes referred to as ``Ineligible Sub-Advisor Changes'').
    \4\ All registered open-end investment companies that currently
intend to rely on the requested order are named as applicants. All
Series that currently are, or that currently intend to be,
Subadvised Series are identified in the application. Any entity that
relies on the requested order will do so only in accordance with the
terms and conditions contained the application. The Series that
currently intend to rely on the requested order, and to be
Subadvised Series are Permal Alternative Select Fund (``Alternative
Select Fund''), a Series of the Equity Trust, and Permal Alternative
Select VIT Portfolio (``Alternative Select Portfolio''), a Series of
Variable Equity Trust. The Alternative Select Portfolio is newly
organized and the Board meeting at which the Advisor will be
appointed as investment adviser has not yet occurred. If the name of
any Subadvised Series contains the name of a Sub-Advisor, the name
of the Advisor or a trademark or trade name that is owned by or
publicly used to identify the Advisor, will precede the name of the
Sub-Advisor.
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    4. The Advisor serves or will serve as the investment adviser to
each Subadvised Series pursuant to an investment advisory agreement
with each Trust (``Investment Management Agreement''). The Investment
Management Agreement for each Subadvised Series has been or will be
approved by the applicable Board, including a majority of the
Independent Board Members and by the shareholders of the applicable
Series as required by sections 15(a) and 15(c) of the Act and rule 18f-
2 thereunder. The terms of the Investment Management Agreements will
comply with section 15(a) of the Act.
    5. Under the terms of each Investment Management Agreement, the
Advisor, subject to the supervision of the Board, will provide
continuous investment management of the assets of the Subadvised
Series. The Advisor will periodically review the Subadvised Series'
investment policies and strategies and may recommend changes to the
investment policies and strategies of the Subadvised Series for
consideration by the Board. For its services to the Subadvised Series
under the Investment Management Agreement, the Advisor will receive an
investment management fee from the Subadvised Series based on the
average net assets of the Subadvised Series. The terms of the
Investment Management Agreement will permit the Advisor, subject to the
approval of the applicable Board, including a majority of the
Independent Board Members, and the shareholders of the Subadvised
Series, to delegate portfolio management responsibilities of all or a
portion of the assets of the Subadvised Series to one or more Sub-
Advisors.
    6. Pursuant to each Investment Management Agreement, the Advisor
will have overall responsibility for the management and investment of
the assets of each Subadvised Series. These responsibilities include
recommending the removal or replacement of Sub-Advisors, determining
the portion of that Subadvised Series' assets to be managed by any
given Sub-Advisor and reallocating those assets as necessary from time
to time.\5\ In accordance with each Investment Management Agreement,
the Advisor will supervise each Sub-Advisor in its performance of its
duties.
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    \5\ Although the Advisor will not normally make day-to-day
investment decisions, it may manage all or a portion of a Subadvised
Series.
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    7. The Advisor will enter into sub-advisory agreements with Sub-
Advisors (``Sub-Advisory Agreements'') to provide investment management
services to the Subadvised Series. The terms of each Sub-Advisory
Agreement will comply fully with the requirements of section 15(a) of
the Act and will be approved by the applicable Board, including a
majority of the Independent Board Members, in accordance with sections
15(a) and 15(c) of the Act and rule 18f-2 thereunder. The Sub-Advisors,
subject to the supervision of the Advisor and oversight of the
applicable Board, will determine the securities and other instruments
or investments to be purchased, sold, or entered into by a Subadvised
Series' portfolio or a portion thereof, and will place orders with
brokers or dealers that they select. The Advisor will compensate each
Sub-Advisor out of the fee paid to the Advisor under the relevant
Investment Management Agreement.
    8. Each Subadvised Series will inform its shareholders of the
hiring of a new Sub-Advisor pursuant to the following procedures
(``Modified Notice and Access Procedures''): (a) within 90 days after a
new Sub-Advisor is hired for any Subadvised Series, that Subadvised
Series will send its shareholders either a Multi-manager Notice or a
Multi-manager Notice and Multi-manager Information Statement; \6\ and
(b) the

Subadvised Series will make the Multi-manager Information Statement
available on the Web site identified in the Multi-manager Notice no
later than when the Multi-manager Notice (or Multi-manager Notice and
Multi-manager Information Statement) is first sent to shareholders, and
will maintain it on that Web site for at least 90 days. In the
circumstances described in the application, a proxy solicitation to
approve the appointment of new Sub-Advisors provides no more meaningful
information to shareholders than the proposed Multi-manager Information
Statement. Applicants state that the Board would comply with the
requirements of sections 15(a) and 15(c) of the Act before entering
into or amending Sub-Advisory Agreements.
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    \6\ A ``Multi-manager Notice'' will be modeled on a Notice of
Internet Availability as defined in rule 14a-16 under the Securities
Exchange Act of 1934 (``Exchange Act''), and specifically will,
among other things: (a) summarize the relevant information regarding
the new Sub-Advisor; (b) inform shareholders that the Multi-manager
Information Statement is available on a Web site; (c) provide the
Web site address; (d) state the time period during which the Multi-
manager Information Statement will remain available on that Web
site; (e) provide instructions for accessing and printing the Multi-
manager Information Statement; and (f) instruct the shareholder that
a paper or email copy of the Multi-manager Information Statement may
be obtained, without charge, by contacting the Subadvised Series.
    A ``Multi-manager Information Statement'' will meet the
requirements of Regulation 14C, Schedule 14C and Item 22 of Schedule
14A under the Exchange Act for an information statement, except as
modified by the order to permit Aggregate Fee Disclosure, as defined
below. Multi-manager Information Statements will be filed with the
Commission via the EDGAR system.
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    9. Applicants also request an order exempting the Subadvised Series
from certain disclosure obligations that may require the applicants to
disclose fees paid by the Advisor to each Sub-Advisor. Applicants seek
relief to permit each Subadvised Series to disclose (as a dollar amount
and a percentage of the Subadvised Series' net assets): (a) The
aggregate fees paid to the Advisor and any Wholly-Owned Sub-Advisors;
(b) the aggregate fees paid to Non-Affiliated Sub-Advisors; and (c) the
fee paid to each Affiliated Sub-Advisor (collectively, the ``Aggregate
Fee Disclosure'').\7\ An exemption is requested to permit the Series to
include only the Aggregate Fee Disclosure. All other items required by
Sections 6-07(2)(a), (b) and (c) of Regulation S-X will be disclosed.
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    \7\ Applicants will only comply with conditions 8, 9, and 12 if
they rely on the relief that would allow them to provide Aggregate
Fee Disclosure.
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Applicants' Legal Analysis

    1. Section 15(a) of the Act states, in part, that it is unlawful
for any person to act as an investment adviser to a registered
investment company ``except pursuant to a written contract, which
contract, whether with such registered company or with an investment
adviser of such registered company, has been approved by the vote of a
majority of the outstanding voting securities of such registered
company.'' Rule 18f-2 under the Act states that any ``matter required
to be submitted . . . to the holders of the outstanding voting
securities of a series company shall not be deemed to have been
effectively acted upon unless approved by the holders of a majority of
the outstanding voting securities of each class or series of stock
affected by such matter.'' Further, rule 18(f)-2(c)(1) under the Act
provides that a vote to approve an investment advisory contract
required by section 15(a) of the Act ``shall be deemed to be
effectively acted upon with respect to any class or series of
securities of such [registered investment] company if a majority of the
outstanding voting securities of such class or series vote for the
approval of such matter.''
    2. Form N-1A is the registration statement used by open-end
investment companies. Item 19(a)(3) of Form N-1A requires a registered
investment company to disclose in its statement of additional
information the method of computing the ``advisory fee payable'' by the
investment company, including the total dollar amounts that the
investment company ``paid to the adviser (aggregated with amounts paid
to affiliated advisers, if any), and any advisers who are not
affiliated persons of the adviser, under the investment advisory
contract for the last three fiscal years.''
    3. Rule 20a-1 under the Act requires proxies solicited with respect
to a registered investment company to comply with Schedule 14A under
the Exchange Act. Items 22(c)(1)(ii), 22(c)(1)(iii), 22(c)(8) and
22(c)(9) of Schedule 14A, taken together, require a proxy statement for
a shareholder meeting at which the advisory contract will be voted upon
to include the ``rate of compensation of the investment adviser,'' the
``aggregate amount of the investment adviser's fee,'' a description of
the ``terms of the contract to be acted upon,'' and, if a change in the
advisory fee is proposed, the existing and proposed fees and the
difference between the two fees.
    4. Regulation S-X sets forth the requirements for financial
statements required to be included as part of a registered investment
company's registration statement and shareholder reports filed with the
Commission. Sections 6-07(2)(a), (b), and (c) of Regulation S-X require
a registered investment company to include in its financial statement
information about the investment advisory fees.
    5. Section 6(c) of the Act provides that the Commission by order
upon application may conditionally or unconditionally exempt any
person, security, or transaction or any class or classes of persons,
securities, or transactions from any provisions of the Act, or from any
rule thereunder, 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.
Applicants state that their requested relief meets this standard for
the reasons discussed below.
    6. Applicants assert that the shareholders expect the Advisor,
subject to review and approval of the applicable Board, to select the
Sub-Advisors who are in the best position to achieve the Subadvised
Series' investment objective. Applicants assert that, from the
perspective of the shareholder, the role of the Sub-Advisors is
substantially equivalent to the role of the individual portfolio
managers employed by an investment adviser to a traditional investment
company. Applicants believe that permitting the Advisor to perform the
duties for which the shareholders of the Subadvised Series are paying
the Advisor--the selection, supervision and evaluation of the Sub-
Advisors--without incurring unnecessary delays or expenses is
appropriate in the interest of the Subadvised Series' shareholders and
will allow such Subadvised Series to operate more efficiently.
Applicants state that each Investment Management Agreement will
continue to be fully subject to section 15(a) of the Act and rule 18f-2
under the Act and approved by the applicable Board, including a
majority of the Independent Board Members, in the manner required by
sections 15(a) and 15(c) of the Act. Applicants are not seeking an
exemption with respect to the Investment Management Agreements.
    7. Applicants assert that disclosure of the individual fees that
the Advisor would pay to the Sub-Advisors of Subadvised Series that
operate under the multi-manager structure described in the application
would not serve any meaningful purpose. Applicants contend that the
primary reasons for requiring disclosure of individual fees paid to
Sub-Advisors are to inform shareholders of expenses to be charged by a
particular Subadvised Series and to enable shareholders to compare the
fees to those of other comparable investment companies. Applicants
believe that the requested relief satisfies these objectives because
the advisory fee paid to the Advisor will be fully disclosed and,
therefore, shareholders will know what the Subadvised Series' fees and
expenses are and will be able to compare the advisory fees a Subadvised
Series is charged to those of other investment companies. Applicants
assert that the requested disclosure relief would benefit shareholders
of the Subadvised Series because it would improve the Advisor's ability
to negotiate the fees paid to Sub-Advisors. Applicants state that the
Advisor may be able to negotiate rates that are below a Sub-Advisor's
``posted'' amounts if the Advisor is not required to disclose the

Sub-Advisors' fees to the public. Applicants submit that the relief
requested to use Aggregate Fee Disclosure will encourage Sub-Advisors
to negotiate lower subadvisory fees with the Advisor if the lower fees
are not required to be made public.
    8. For the reasons discussed above, Applicants submit that the
requested relief meets the standards for relief under section 6(c) of
the Act. Applicants state that the operation of the Subadvised Series
in the manner described in the application must be approved by
shareholders of a Subadvised Series before that Subadvised Series may
rely on the requested relief. In addition, Applicants state that the
proposed conditions to the requested relief are designed to address any
potential conflicts of interest, including any posed by the use of
Wholly-owned Sub-Advisors, and provide that shareholders are informed
when new Sub-Advisors are hired. Applicants assert that conditions 6,
7, 10 and 11 are designed to provide the applicable Board with
sufficient independence and the resources and information it needs to
monitor and address any conflicts of interest with affiliated person of
the Advisor, including Wholly-Owned Sub-Advisors. Applicants state
that, accordingly, they believe the requested relief 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.

Applicants' Conditions

    Applicants agree that any order granting the requested relief will
be subject to the following conditions:
    1. Before a Subadvised Series may rely on the order requested in
the application, the operation of the Subadvised Series in the manner
described in the application, including the hiring of Wholly-Owned Sub-
Advisors, will be approved by a majority of the Subadvised Series'
outstanding voting securities as defined in the Act, or, in the case of
a new Subadvised Series whose public shareholders purchase shares on
the basis of a prospectus containing the disclosure contemplated by
condition 2 below, by the sole initial shareholder before offering the
Subadvised Series' shares to the public.
    2. The prospectus for each Subadvised Series will disclose the
existence, substance, and effect of any order granted pursuant to the
application. Each Subadvised Series will hold itself out to the public
as employing the multi-manager structure described in the application.
Each prospectus will prominently disclose that the Advisor has the
ultimate responsibility, subject to oversight by the applicable Board,
to oversee the Sub-Advisors and recommend their hiring, termination and
replacement.
    3. The Advisor will provide general management services to a
Subadvised Series, including overall supervisory responsibility for the
general management and investment of the Subadvised Series' assets.
Subject to review and approval of the applicable Board, the Advisor
will (a) set a Subadvised Series' overall investment strategies, (b)
evaluate, select, and recommend Sub-Advisors to manage all or a portion
of a Subadvised Series' assets, and (c) implement procedures reasonably
designed to ensure that Sub-Advisors comply with a Subadvised Series'
investment objective, policies and restrictions. Subject to review by
the applicable Board, the Advisor will (a) when appropriate, allocate
and reallocate a Subadvised Series' assets among multiple Sub-Advisors;
and (b) monitor and evaluate the performance of Sub-Advisors.
    4. A Subadvised Series will not make any Ineligible Sub-Advisor
Changes without such agreement, including the compensation to be paid
thereunder, being approved by the shareholders of the applicable
Subadvised Series.
    5. A Subadvised Series will inform shareholders of the hiring of a
new Sub-Advisor within 90 days after the hiring of a new Sub-Advisor
pursuant to the Modified Notice and Access Procedures.
    6. At all times, at least a majority of the applicable Board will
be Independent Board Members, and the selection and nomination of new
or additional Independent Board Members will be placed within the
discretion of the then-existing Independent Board Members.
    7. Independent Legal Counsel, as defined in rule 0-1(a)(6) under
the Act, will be engaged to represent the Independent Board Members.
The selection of such counsel will be within the discretion of the
then-existing Independent Board Members.
    8. The Advisor will provide the applicable Board, no less
frequently than quarterly, with information about the profitability of
the Advisor on a per Subadvised Series basis. The information will
reflect the impact on profitability of the hiring or termination of any
sub-advisor during the applicable quarter.
    9. Whenever a sub-advisor is hired or terminated, the Advisor will
provide the applicable Board with information showing the expected
impact on the profitability of the Advisor.
    10. Whenever a sub-advisor change is proposed for a Subadvised
Series with an Affiliated Sub-Advisor or a Wholly-Owned Sub-Advisor,
the applicable Board, including a majority of the Independent Board
Members, will make a separate finding, reflected in the applicable
Board minutes, that such change is in the best interests of the
Subadvised Series and its shareholders and does not involve a conflict
of interest from which the Advisor or the Affiliated Sub-Advisor or
Wholly-Owned Sub-Advisor derives an inappropriate advantage.
    11. No Board member or officer of a Subadvised Series, or partner,
director, manager, or officer of the Advisor, will own directly or
indirectly (other than through a pooled investment vehicle that is not
controlled by such person), any interest in a Sub-Advisor, except for
(a) ownership of interests in the Advisor or any entity, except a
Wholly-Owned Sub-Advisor, that controls, is controlled by, or is under
common control with the Advisor, or (b) ownership of less than 1% of
the outstanding securities of any class of equity or debt of a publicly
traded company that is either a Sub-Advisor or an entity that controls,
is controlled by, or is under common control with a Sub-Advisor.
    12. Each Subadvised Series will disclose the Aggregate Fee
Disclosure in its registration statement.
    13. In the event the Commission adopts a rule under the Act
providing substantially similar relief to that requested in the
application, the requested order will expire on the effective date of
that rule.

    For the Commission, by the Division of Investment Management,
under delegated authority.
Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2014-04555 Filed 2-28-14; 8:45 am]
BILLING CODE 8011-01-P


About the Award
Eligibility:  	Retailers of ENERGY STAR certified products. To be eligible for an award, applicant must be a partner in good standing, having complied with applicable partner commitments. Additionally, please read the separate General Instructions for all applicants.

          Regional retailers and specialized retailers are encouraged to apply and will be evaluated commensurate with their size and product focus.

          Buying groups and/or retail member groups are encouraged to apply. Buying groups should consider the same award evaluation criteria in compiling their application as retailers, but should focus on demonstrating how they supported their retail members' accomplishments in relation to the criteria, particularly for Product Specification and Stocking, Sales Associate Training, and Marketing and Communications.

          E-tailers, who have no storefronts, are encouraged to apply. E-tailers should consider the same award evaluation criteria in compiling their application as retailers, with the exception of Sales Associate Training and Marketing and Communications tactics related to in-store.

Description:	Retailers, both large and small, are making an ever-increasing contribution to the growing success of ENERGY STAR. As ENERGY STAR retail partner participation in the program continues to expand, we are dedicated to recognizing the very best in terms of a broad commitment to and success with ENERGY STAR.

 Each retailer excels in specific areas relative to their size and specialty. Applications will be reviewed with this in mind and, depending on the applicant pool, a separate retail Partner of the Year award may be given to a small, regional, or specialized retailer.

 Narrative:	(Required)
	Your narrative description should be no more than 10 pages and should be accompanied by samples of specific outreach materials representing your 2019 activities, such as strategies, examples of participation in EPA Annual Promotions and other ENERGY STAR specific company-produced materials and initiatives.

          Accomplishments -- Organizations applying for the Partner of the Year Award should highlight their accomplishments from 2019, and if possible, cumulative accomplishments. Since applications are due on December 2, 2019, this will provide retailers an opportunity to share your accomplishments starting earlier in the season rather than the start of the calendar year (i.e., November 2018  -  November 2019). When highlighting cumulative accomplishments, please ensure that you include a timeframe (e.g., saved more than $10 million since 2001).

Supporting Materials: (a minimum of 1 required)
 Applicants should submit electronic samples of program materials and examples to accompany the narrative description. Additionally, EPA may also validate incorporation of the ENERGY STAR label by reviewing use of the ENERGY STAR logo and educational content of the applicant's website.

 Applicants should not submit or send hard copies/physical copies of supporting materials.

                                               BEGIN APPLICATION

                         PART 2:
Award Accomplishment Document
                (use the following information to create a Word or PDF file)

 In describing your company's activities, please organize your submission document consistent with the outline below, and be as specific as possible per the instructions for each criterion.

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Award Evaluation Criteria and Outline

Section 1: ENERGY STAR Partnership and Planning
Partner should document any and all planning meetings held with EPA to discuss general coordination and collaboration.  This can include in-person, and telephone meetings where high level objectives were discussed.  Please also provide information on how EPA was provided access and coordinated with merchants and other internal decision-making groups.

Section 2: Product Stocking and Sales

In this section, retailers should show how they worked to order and stock ENERGY STAR products in store and on-line. Leading retailers are expected to work to increase stocking and sales of ENERGY STAR products every year. This means working with suppliers to increase the number of SKUs/models and/or percentage of sales in EPA priority product categories. Please include stocking and sales information in the format below.

(Note: Cut and paste this table into your Accomplishments document for editing)
                              Stocking and Sales
                                   Lighting
                                  Appliances
                             Consumer Electronics
                                 Water Heaters
                                Other Products
Number of ENERGY STAR certified models available in 2019
                             Click to enter text.
Click to enter text.
                             Click to enter text.
                             Click to enter text.
                             Click to enter text.
Percentage change over number of certified models available in 2018
                             Click to enter text.
                             Click to enter text.
                             Click to enter text.
                             Click to enter text.
                             Click to enter text.
Percentage of eligible 2019 models that are ENERGY STAR certified
                             Click to enter text.
                             Click to enter text.
                             Click to enter text.
                             Click to enter text.
                             Click to enter text.
Percentage of total sales (ENERGY STAR vs. non-ENERGY STAR units) in 2019
                             Click to enter text.
                             Click to enter text.
                             Click to enter text.
                             Click to enter text.
                             Click to enter text.
Percentage total sales (ENERGY STAR vs. non-ENERGY STAR units) change over 2018
                             Click to enter text.
                             Click to enter text.
                             Click to enter text.
                             Click to enter text.
                             Click to enter text.

Please provide any additional context for decreases in product selection or sales, as appropriate. Retailers should also identify and provide examples of specific activities in support of increasing the availability of ENERGY STAR products, including coordination with manufacturers and/or suppliers.

Include any information on collaboration with EPA, manufacturers, and energy efficiency program sponsors/utilities in changes to stocking practices. For ENERGY STAR Retail Products Platform (ESRPP) members, include ESRPP related stocking activities in Section 5.

Section 3: Product Marketing and Promotions

In this section, retailers should show how they worked to order, stock and promote ENERGY STAR products in store and on-line. Retailers should also identify and provide examples of specific activities in support of efforts to increase visibility of ENERGY STAR products online and in-store for each product category.

Clearly identify if specific ENERGY STAR-provided content or a specific ENERGY STAR-provided tool was used in an activity, including ENERGY STAR promotion such as:

 Laundry Made Better
 Flip Your Fridge
 Light the Moment
 The Cool Choice for Room AC
 Upgrade Now and Warm Up to Savings (Water Heaters)
 The Smart Choice Made Simple (Smart Thermostats), and
 Make a Savings Splash (Pool Pumps)
For these efforts, include any information on collaboration with EPA, manufacturers, and Energy Efficiency Program Sponsors (EEPS)/utilities in the development of these marketing and promotional activities.

 In Store Product Marketing and Promotions
      Identify and provide examples of content promoting ENERGY STAR certified products and their benefits in-store.  For each product area, include specific examples of activities that included ENERGY STAR benefits such as:
 Product category or product specific how-to, selection, or category signage
 In-store kiosk or selection tools
 Signage created/cobranded with utilities and EEPS
 Public Address/overhead announcement messaging (include script and/or audio)
 In-store events

 Retailer Website Product Marketing and Promotions
      Identify and provide examples of content promoting ENERGY STAR certified products and their benefits in each product category on the retail website.  Include specific examples of web content, such as:
 Product overviews and how-to guides
 Display ads on the retailer site
 Use of the certification mark and/or appropriate wording on search result pages and product detail pages
 Inclusion of an ENERGY STAR filter for product selection
 ENERGY STAR partnership on corporate sustainability website

Additional instructions: Do not include examples that do not specifically highlight ENERGY STAR. For example, if you have an in-store promotion and giveaway for an ENERGY STAR certified refrigerator, but do not specifically highlight/promote the product as ENERGY STAR certified, then the promotion would not be counted in your favor.

Section 3: Overall ENERGY STAR Education and Promotion
This section is to demonstrate what your company has done throughout the year to promote ENERGY STAR and educate consumers about energy efficiency and its environmental and other benefits through general efforts, such as advertising, social media, public relations, events, etc.

Company should provide examples of the following ENERGY STAR consumer outreach activities:
 Advertising (including television spots, radio spots, newspaper circulars, display ads on non-retailer websites, e-newsletters, promotional emails, direct mail, and search engine advertising)
 Social media (including Facebook, YouTube, partnerships with influencers, and blog posts)
 Public Relations (including press releases, content syndication, or a retailer's media portal)
 Consumer materials that show environmental benefits messaging, such as climate protection
Clearly identify if specific ENERGY STAR-provided content or a specific ENERGY STAR-provided tool was used in an activity, such as posting a suggested ENERGY STAR partner message on social media.
Additional instructions: Do not include examples that feature ENERGY STAR products, but do not mention or highlight ENERGY STAR. For example, a Public Relations campaign for a clothes washer that is ENERGY STAR certified, but the campaign fails to mention additional education specific to ENERGY STAR would not count in your favor. It is not necessary or advantageous to submit copies of all advertising materials; samples with additional references of placement is sufficient.
Section 4: ENERGY STAR Training and Internal Education Efforts
In this section, retailers should demonstrate what they have done throughout the year to educate internal stakeholders and sales associates about the ENERGY STAR program and the value of ENERGY STAR certified products. Please do not include trainings that include the ENERGY STAR certification mark but do not specifically address the program or explain its benefits.

Please describe how your organization has achieved the following goals:
    Integration of ENERGY STAR into your organization's sales force and employee training. Provide scope, description of efforts, measures of impact, and examples (e.g., training manuals, new employee packets, presentations, etc.)
    Cooperation with product brand owners, manufacturers, or utility/state/regional partners to increase ENERGY STAR information in product knowledge training. Provide scope, description of efforts, measures of impact and examples (e.g., collateral, e-mails, screen shots of web-based, video, manuals, newsletters, presentations, ENERGY STAR specification summary sheets, etc.)
    Use of intranets or internal social sites
    Internal product fairs or events
    Collaboration with EPA in the development of training activities

Additional instructions: Please provide copies of training scripts and/or links to video files, where possible. (Upload under PART 3: Supporting Materials). Screenshots of training videos or of trainers with certified products are not sufficient evidence of training. Please do not include examples of training or promotions that feature ENERGY STAR certified products, but do not specifically mention ENERGY STAR.
ENERGY STAR Retail Products Platform (ESRPP) Participants Only
Section 5: ENERGY STAR Retail Products Platform
EPA is working with a national group of program managers and retailers to develop a more streamlined approach to energy efficiency.  If your company is participating in this effort, please outline the following:
 Date joined (first agreement signed)
 Number of stores covered by partnerships
 Participation in Retail Action Council meetings and ESRPP-related participation at ENERGY STAR national partner meetings
 Brief description of presentations on ESRPP made by your company at national forums or conferences

                 Prepare/Gather Remaining Documents for Upload

PART 3: Supporting Materials (at least one required, as described in the Application Instructions above)
    PART 4: Organization's High-Resolution Logo (required)

ENERGY STAR[(R)] is the simple choice for energy efficiency. For 25 years, EPA's ENERGY STAR program has been America's resource for saving energy and protecting the environment. Join the millions already making a difference at energystar.gov.

ENERGY STAR[(R)] is the simple choice for energy efficiency. For 25 years, EPA's ENERGY STAR program has been America's resource for saving energy and protecting the environment. Join the millions already making a difference at energystar.gov.

ENERGY STAR[(R)] is the simple choice for energy efficiency. For 25 years, EPA's ENERGY STAR program has been America's resource for saving energy and protecting the environment. Join the millions already making a difference at energystar.gov.

ENERGY STAR[(R)] is the simple choice for energy efficiency. For 25 years, EPA's ENERGY STAR program has been America's resource for saving energy and protecting the environment. Join the millions already making a difference at energystar.gov.


[Federal Register: January 29, 2009 (Volume 74, Number 18)]
[Notices]
[Page 5199]
[DOCID:fr29ja09-106]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-59185; File No.
SR-NYSE-2008-141]

Self-Regulatory Organizations; New York Stock Exchange LLC;
Notice of Filing and Order Granting Accelerated Approval of Proposed
Rule Change To Extend the Pilot Period for the NYSE Realtime Reference
Prices Pilot Program

Correction

    In notice document E9-9 beginning on page 749 in the issue of
Wednesday, January 7, 2009 make the following correction:
    On page 750, in the third column, in the last line of the first
paragraph, ``January 27, 2009'' should read ``January 28, 2009''.

[FR Doc. Z9-9 Filed 1-28-09; 8:45 am]

BILLING CODE 1505-01-D


Interim Quantitative Method for Evaluating the Efficacy of Antimicrobial Test Substances on Porous Surfaces against Viruses
                                 (12/08/2022)

Scope
The Environmental Protection Agency (EPA) Office of Pesticide Programs (OPP) recommends that applicants utilize this interim method to support the registration of disinfectant products with claims for efficacy against viruses when used on soft-porous surfaces.
This method is quantitative and provides log reduction (virus inactivation) as the quantitative measure of efficacy for disinfectants against viruses on soft-porous surfaces.
Method Overview
In brief, the method uses 1 cm diameter discs (carriers) of a set of materials to represent soft-porous surfaces. Each disc receives 10 uL of microbial inoculum (with a three-part organic and inorganic soil load) deposited in the center of each carrier. The inoculum is allowed to dry and is then exposed to 50 uL of the antimicrobial treatment; control carriers receive an equivalent volume of an innocuous fluid (e.g., growth media). The exposure time is allowed to elapse; a liquid neutralizer is then added to the vial to halt the antimicrobial action. Each vial with the carrier is vortexed, serially diluted, and plated onto cells to recover viable virus. The presence of viable virus particles is determined as applicable to the test system (e.g., cytopathic effect (CPE), direct fluorescent antibody (DFA) stain, hemagglutination, etc.). Based on the difference between the mean log10 density values of the untreated control and treated carriers, a log10 reduction (LR) in viable virus is calculated. The LR value is used as the measure of product effectiveness.
Appropriate biosafety procedures should always be used when working with laboratory test systems which include human pathogenic microorganisms. Laboratory safety is discussed in the current edition of "Biosafety in Microbiological and Biomedical Laboratories (BMBL)" 6[th] edition, from the subject matter experts within the U.S. Department of Health and Human Services (HHS), including experts from the Centers for Disease Control and Prevention (CDC) and National Institutes of Health (NIH).
                               TABLE OF CONTENTS

1) Special Apparatus and Materials...............................................................
3
2) Carriers.............................................................................................
5
3) Carrier Inoculation ...............................................................................
6
4) Performance Assessment  -  Efficacy..........................................................
8
5) Data Requirements...............................................................................
10
Attachment 1: Neutralization Assay and Flowchart.............................................
11
Attachment 2: Cytotoxicity Determination.......................................................
13

 Special Apparatus and Materials
 Test Virus, use appropriate virus to be claimed on the label.
 Cell Line, appropriate for the virus tested.
 Media and reagents:
 Complete Growth Media (CGM). Consisting of Minimum Essential Media and FBS or other medium specified for the virus being tested. Used for cell line propagation, viral propagation, and serial dilution. Antibiotics and/or antifungals may be added to reduce potential contamination.
 Minimum Essential Media (MEM). Liquid or powder form (e.g. Eagle's or Dulbecco's). Used to prepare complete growth media.  Prepare per manufacturer's guidelines.
 Heat Inactivated Fetal Bovine Serum (FBS). Compatible for use with cell lines. Often used to prepare complete growth media.
 Neutralizer. Used to inactivate and/or dilute the antimicrobial treatment to end the contact time.
 Note: The recommended neutralizer for the test system is the same medium used to grow the virus (e.g., CGM). If the neutralization confirmation assay demonstrates that CGM is ineffective, other neutralizers may be used.
 Dulbecco's Phosphate buffered saline (DPBS). Or other equivalent buffer (e.g. PBS, Earle's Balanced Salt Solution). Prepare per manufacturer's guidelines.
 Antibiotic/antifungal. 100x Amphotericin B/Penicillin/Streptomycin solution or other equivalent antibiotic/antimycotic solution. May be used to prevent contamination of cell culture.
 Soil load, 3-part. Use as the soiling agent.  Add to the test suspension in the following manner:
 BSA: Add 0.5 g bovine serum albumin (BSA, radio immunoassay (RIA) grade or equivalent, CAS# 9048-46-8) to 10 mL of PBS, mix and pass through a 0.2 um pore diameter (polyethersulfone) membrane filter, aliquot (e.g., a minimum of 50 uL), and store at -20+-2°C.
 Yeast Extract: Add 0.5 g yeast extract to 10 mL of PBS, mix, and pass through a 0.2 um pore diameter (polyethersulfone) membrane filter, aliquot (e.g., a minimum of 70 uL), and store at -20+-2°C.
 Mucin: Add 0.04 g mucin (from bovine submaxillary gland, CAS # 84195-52-8) to 10 mL of PBS, stir or vortex-mix until thoroughly dissolved, and pass through a 0.2 um pore diameter (polyethersulfone) membrane filter, aliquot, and store at -20+-2°C.
 The three stock solutions of the soil load are single use only.  Do not refreeze; store up to one year at 20+-2°C.
 Antimicrobial Test Substance. Ready-to-use, activated, or concentrated antimicrobial. If the antimicrobial test substance is prepared by diluting a concentrate in hard water, then use prepared test substance within 3 hours of preparation or as otherwise instructed by the manufacturer. Measuring error increases as delivery volume decreases. To minimize variability due to measuring error, a minimum of 1.0 mL or 1.0 g of concentrated antimicrobial test substance should be used when preparing use-dilutions for testing. Use v/v dilutions for liquid antimicrobial test substances and w/v dilutions for solid antimicrobial test substances. The use of a positive displacement pipette is recommended for viscous liquids.
 375ppm hard water. Used as a diluent for the preparation of antimicrobial test substances. Adjust the recipe for volumes other than 1 L.
 Prepare Solution A by dissolving 19.84 g anhydrous magnesium chloride (or 42.36 g MgCl·6H2O) and 46.24 g anhydrous calcium chloride (CaCl2) in de-ionized water and dilute to 1,000 mL. Sterilize by membrane filtration. Store the solution in the refrigerator (2-8°C) for up to 30 days; do not use after that time.
 Prepare Solution B by dissolving 35.02 g sodium bicarbonate (NaHCO3) in water and dilute to 1,000 mL. Sterilize by membrane filtration. Store the solution in the refrigerator (2-8°C) for up to 30 days; do not use after that time.
 To prepare 1 L of 375 ppm hard water, place 600-700 mL of deionized water in a 1,000 mL volumetric flask and add 6.0 mL of Solution A and then 8.0 mL of Solution B. Mix and add water to the flask to reach 1,000 mL. The pH of the hard water should be 7.0+-0.2 at room temperature. If necessary, adjust the pH by using 1 N NaOH or 1 N HCl.  Sterilize by membrane filtration. Ensure sterility of hard water.
 Prepare the hard water under aseptic conditions and use within 5 days of preparation. On the day of the test, measure the hardness of the water using a HACH water hardness test kit or other suitable titration method.
 The target hardness expressed as mg/L calcium carbonate (CaCO3) is 375 mg/L +5%/-10% (338-394 ppm).
 Water. De-ionized (DI), distilled water or water with equivalent quality for making reagent solutions and culture media.
 Apparatus
 Carriers: Discs (1 cm in diameter) cut from porous material.  Carriers are single use only.  See section 2 for carrier specifications.
 Hole punch: If necessary, for use in the preparation of 1 cm discs from material.  Model number: SKU# HP-MEI448R or equivalent.
 Calibrated 10 uL positive displacement pipette with corresponding 10 uL tips, for carrier inoculation.
 Filter paper. Whatman No. 2, to line glass Petri plates.
 Calibrated micropipettes (e.g., 200 uL, 1 mL) with appropriate corresponding tips, for deposition of test substance on carriers and preparing dilutions.
 Forceps, straight or curved, non-magnetic, disposable with smooth flat tips to pick up the carriers for placement in vials.
 Vials with lids (plastic or comparable). Sterile, flat-bottomed, wide-mouthed (at least 25 mm diameter), approximately 20 mL capacity, for holding inoculated carriers to be exposed to the test chemical and for accommodating neutralizer.
 Transparent vials are more desirable to facilitate application of 50 uL test substance or control substance to inoculated carrier.
 Certified timer. Readable in minutes and seconds, for tracking of timed events and intervals.
 Desiccation unit (with gauge to measure vacuum) with fresh desiccant (e.g., anhydrous CaCl2). For drying inoculated carriers.
 Vacuum source. In-house line or suitable vacuum pump capable of achieving 0.068 to 0.085 MPa, for drying inoculated carriers in desiccation unit and to perform membrane filtration.
 Titration kit (e.g. Hach digital titrator). For measuring water hardness.
 Vortex-style mixer. For vortex-mixing of various solutions.
 15 mL conical centrifuge tubes. For serial dilutions.
 Water bath. To maintain cell culture media at 37+-1°C.
 Tissue/cell culture flasks (tissue culture treated). Flasks for cell propagation.
 Cell plates. 24-well plates used to assay virus from control and treated carriers.
 Centrifuge (with swinging bucket rotor). For preparing frozen virus stock.
 Ultracentrifuge (capable of spinning 100,000 x g). For concentrating virus stock if needed.
 Inverted microscope. For viewing cells.
 Incubator with 5% CO2. For incubation of virus/cell line test system

 Carriers
 Carrier Materials (see Figure 1)
 Privacy Curtain Fabric (PCF-03): 54% Polyester, 46% Fire Resistant (FR) Polyester. CF Stinson, LLC. Mambo MAM34 Nights.
 Non-PVC Fabric (NVF-01): Polyurethane Face made with Polycarbonate and Polyether Resins, Polyester Backing. CF Stinson, LLC. Kid BlueSky KID17.
 Vinyl Seating Fabric (VF-01): Vinyl Face, Polyester Backing. CF Stinson, LLC. Hopsack - HOP24 Fjord.
                                           Vinyl
                                    (VF-01)
                                Privacy Curtain
                                   (PCF-03)
                                    Non-PVC
                                   (NVF-01)
Figure 1: Examples of carrier materials cut into 1 cm discs; materials 2.a.i, 2.a.ii, and 2.a.iii (from left to right)
 Carrier Preparation
 Punch 1 cm round carriers or use comparable cutting procedure from fabric.
 Visually screen carriers to ensure consistent surface characteristics; trim any jagged edges or loose fabric.
 No pre-cleaning of carriers is necessary. To sterilize carriers, sterilize using a gravity cycle, 121°C for 20 minutes; ensure carriers are dry following sterilization. Test sterility of carriers prior to testing.
 Carriers may not be entirely flat after autoclaving; however, minor distortion of carriers is acceptable for testing.
 Prior to use in testing, document the condition of the screened and sterile carriers (e.g., digital photographs).
    Carrier Cytotoxicity Check
 Each carrier type should be tested for any cytotoxic effects on the cell line. Place a carrier into 10 mL of the proposed neutralizer and let soak for ten minutes. Add 1 mL per well of this solution to a 24 well plate with a confluent monolayer of cells. Incubate plate at the required conditions and time; observe daily for cytotoxicity. No cytotoxicity should be observed.

 Carrier Inoculation
 Propagate the virus on the appropriate cell line.
   Note: Concentration of the virus stock (~100,000 x g for 4 hours at 4º C) may be necessary to achieve adequate control counts.
 Defrost a cryovial rapidly to avoid loss in the viability of the preserved virus (e.g., place in a 37ºC water bath and use within 15 min after thawing).
 Dilute the virus stock with CGM to achieve control counts in the range of 4.0 to 5.5 logs virus particles/carrier.
 Use the diluted virus to prepare the final test suspension with the addition of the soil load.
 To obtain 500 uL of the final test suspension with the 3-part soil load, vortex-mix each component and combine in the following order using a calibrated micropipette (smaller volumes may be used proportionally):
 25 uL BSA stock
 35 uL yeast extract stock
 100 uL mucin stock
 Vortex soil suspension for 10 s prior to adding microbial test suspension.
 340 uL virus test suspension
 It is advisable to briefly rescreen each sterilized carrier for abnormalities prior to inoculation. Place carriers screened side up inside an empty, sterile plastic Petri dish (no more than 20 carriers/dish).
 Privacy curtain carriers have no backing material and may be inoculated on either side
 Non-PVC and vinyl carriers are layered materials comprised of a smooth, colored top surface and a white fabric bottom; only the top surface will be inoculated.
 Vortex-mix the final test suspension for 10 s following the addition of the virus test suspension and immediately prior to use. Inoculate carriers within 30 min of preparation.
 If a smaller test suspension is prepared, pipetting to mix may be used.
 Inoculate the number of carriers required for the evaluation of the test substance (3 controls and 5 treated) along with a few extra carriers.
 Using a calibrated positive displacement pipette with a 10 uL tip, withdraw 10 uL of the final test suspension and deposit it at the center of each carrier (clean, screened and sterile); avoid contact of pipette tip with carrier and do not spread the final test suspension with the pipette tip.
 For consistency, vortex-mix the final test suspension frequently during inoculation of the carrier set.
 The same pipette tip may be used to inoculate all carriers (unless the tip is compromised).
 Discard any inoculated carrier where the final test suspension has run over the edge.
 Transfer the Petri dish(es) with the inoculated carriers into a desiccation unit (with desiccant) and completely remove the lid of the Petri dish. Close the desiccation unit door (or lid) and seal the unit. Apply vacuum to evacuate the desiccation unit.
 Maintain and monitor the vacuum level using a gauge. Achieve and maintain consistent level of vacuum (at 20-25 in of mercury, 508-635 torr, 677-847 mbar, or 68000-85000 Pascal) throughout the carrier drying process.
 Hold the inoculated carriers in the evacuated desiccation unit at 21+-3°C for 45 to 60 min. Inspect inoculated carriers to verify that they are not visibly wet and remove from desiccation unit. Do not use carriers that are visibly wet for testing.
 Record the time for all timed events.
 Depressurize the desiccator slowly to avoid the potential for carriers to move or flip.
 Use dried inoculated carriers for testing within 30 min following removal from desiccation unit; hold carriers in closed Petri dish at room temperature (21+-3°C) until use.

 Performance Assessment  -  Efficacy
 Evaluate 3 untreated control carriers and 5 treated carriers per test substance.
 One set of untreated control carriers may be used for evaluating multiple test substances against the same virus on the same test day (assuming the carrier material, neutralizer, and soil load are the same).
 Using sterile forceps, transfer each dried carrier with the inoculated side up to a flat-bottom vial and cap the vial. Repeat until all carriers are transferred.
 Prepare the antimicrobial test substance.  Use antimicrobial test substance within 3 hours of preparation or as specified by the manufacturer.
 In a timed fashion with appropriate intervals, sequentially deposit 50 uL of the test substance (equilibrated to 21+-3°C) with a calibrated micropipette over the dried inoculum on each test carrier, ensuring complete coverage.
 Note: Gently apply the antimicrobial test substance at a perpendicular angle to the inoculated carrier; do not forcefully deposit the disinfectant.
 Use a new tip for each carrier; do not touch the carrier surface with a pipette tip during the application of the test substance or the control substance; replace with new carrier(s) and vial(s) if this occurs. Do not cap the vials.
 For non-foaming aerosols and pump/trigger spray products, obtain the test substance by dispensing the product into a sterile vessel for collection. Cap the vessel and use dispensed product within 30 min.
 For foaming spray formulations, allow the foam to break down for at least 5-10 minutes for the generation of a 1-2 mL liquid sample. Cap the vessel and use dispensed product within 30 min.
 Do not process carriers where the test substance runs off the carrier or does not completely cover the inoculum spot; replace with new carrier(s) and vial(s) if this occurs.
 Conduct the test at room temperature (21+-3°C) for the selected contact time. Use a certified timer to ensure that each carrier receives the required contact time.
 Process control carriers last. Each control carrier receives 50 uL CGM equilibrated to 21+-3°C, instead of the test substance. Hold the control carriers for the same contact time as used for the test substance.
 Within +-5 s of the end of the contact period, add neutralizer equilibrated to 21+-3°C to each vial in the specified order according to the predetermined schedule.  Briefly vortex-mix (2-3 s) each vial following the addition of the neutralizer.
 The vial containing the neutralized solution with carrier is considered to be the 10[0] dilution.
 Use the same neutralizer for the control carriers as that for the treated carriers.
 If deemed necessary, the final volume of neutralizer may be increased to 20 mL (for all carriers).
 Following the neutralization of the entire set of carriers, vortex-mix each vial for 30+-5 s at high speed to recover and disaggregate the inoculum. Do not remove the carrier from the vial.
 Initiate dilutions within 30 min after neutralization and vortex-mixing. Initiate inoculation of cell line within 30 min of preparing the dilutions.
 Titrate the samples for virus infectivity using the appropriate cell line using 8 wells per dilution.
 Plate a minimum of 80% of the volume (8mL for 10 mL neutralizer, 16 mL for 20 mL) of the 10[0] vial and of each dilution tube.
 Remove the growth medium from each well of the plate with a confluent monolayer of cells and replace with the maximum volume of the dilution tube (i.e. add 1 mL per well for a 24 well plate) working from most dilute to least dilute.
 The elution steps for control carriers are the same as for the test carriers; use 10-fold dilutions to achieve 4.0  -  5.5 logs virus particles/carrier.
 If cytotoxicity was observed in pre-neutralization testing and/or on the cytotoxicity control, CGM may be removed from all wells in the affected dilutions at the appropriate time (one hour minimum) and wash them with pre-warmed PBS, then replace the PBS with fresh CGM.
 Incubate test and control plates as appropriate for the test system.
 Data Requirements
 Record all observations (presence/absence of viable virus particles) and use in calculations to estimate the log reduction based on the TCID50 or MPN (most probably number) technique.
 Use values with at least three significant figures when performing calculations (e.g., log density, mean log density). Report the final mean log reduction value with two significant figures (e.g., round up to the nearest tenth).
 Calculate the TCID50/carrier or MPN/carrier. Calculate the log density of each carrier by taking the log10 of the density (per carrier).
 Calculate the mean log10 density across treated carriers.
 Calculate the mean log10 density across control carriers.
Calculate the log10 reduction (LR) for treated carriers: log10 reduction = mean log10 control  -  mean log10 treated.

Attachment 1
                             Neutralization Assay
   The purpose of this section is to assess the effectiveness of the neutralization processes associated with this method. Perform the neutralization assay prior to testing to demonstrate the neutralizer's ability to inactivate the chemical and determine if there is interference from the carrier itself.
   Select a neutralizing medium that is not inhibitory to the virus and is not cytotoxic to the cells. The acceptance criteria for acceptable neutralization is 0.5 log difference between the neutralization effectiveness, neutralization toxicity control, titer control, and carrier control.  Interaction between the neutralizer and product and its effect on the cell line must be determined prior to testing.
 Prepare Test Suspension A: Dilute the virus stock suspension in CGM to achieve an average recovered concentration of approximately 2-3 logs (i.e., 100-1000 virus particles) per vessel for the Titer Control sample. To achieve this, dilute the virus stock suspension through 10[-4] (or as necessary).
 Prepare Test Suspension B: Prepare the soil load: vortex each component and combine 25 uL bovine serum albumin (BSA), 35 uL yeast extract, 100 uL of mucin, and 340 uL of Test Suspension A (0.5 mL total volume) and mix well. Use Test Suspension B within 30 minutes of preparation.
 Neutralization Treatments (Figure 2)
 Treatment 1: Neutralizer Effectiveness. Add 50 uL of the test substance to each of three test tubes. At timed intervals, add 10 mL (up to 20 mL) neutralizer to each vessel and briefly swirl (by hand). After 10+-2 s, gently add 10 uL of Test Suspension B using a micropipette to each vessel. Use a new tip for each tube. Vortex each tube for 3-5 s.  Proceed with step 3.
 Treatment 2: Neutralizer Toxicity Control. Add 10 mL neutralizer to each of three reaction vessels. At timed intervals, add 10 uL of Test Suspension B using a micropipette to each vessel. Use a new tip for each tube. Vortex each tube for 3-5 s. Proceed with step 3.
 Treatment 3: Titer Control. Add 10 mL CGM to each of three reaction vessels. At timed intervals, add 10 uL of Test Suspension B using a micropipette to each vessel. Use a new tip for each tube. Vortex each tube for 3-5 s. Proceed with step 3.
 Treatment 4: Carrier Interference Control. Add 10 mL CGM and one sterile carrier to each of three reaction vessels. At timed intervals, add 10 uL of Test Suspension B using a micropipette to each vessel. Use a new tip for each tube. Vortex each tube for 3-5 s. Proceed with step 3.
 Note: Steps should be conducted at timed intervals (e.g., 30 s) to ensure consistent time of contact for each carrier.
 Hold the neutralization treatments for 10+-1 minutes at room temperature (21+-3°C).
 At the conclusion of the holding period, vortex each tube for 3-5 s. Serially dilute the sample as needed (e.g., remove 1 mL of sample and dilute in 9 mL of CGM).
 Initiate dilution and plating as soon as possible (e.g., within 5 minutes).  Two analysts are recommended to perform vortexing and dilution steps to reduce holding time after vortexing.
 Titrate the samples for virus infectivity using the appropriate cell  -  plate a minimum of 80% of the 10[0] vial and all dilutions.
 For each well plated, add the maximum volume of the well (i.e. add 1 mL per well for a 24 well plate).
 Note: If any 10[0] (vessel) dilution is used that does not contain CGM (e.g. Treatment 2 with proposed neutralizer), allow it to adsorb on the cells for 1 hr, then remove and replace with fresh CGM.
 If cytotoxicity was observed in pre-neutralization testing CGM may be removed from all wells in the affected dilutions at the appropriate time (one hour minimum) and wash them with pre-warmed PBS, then replace the PBS with fresh CGM. Also wash with pre-warmed PBS and replace the CGM in the same dilutions for the control carriers.
 Incubate test and control plates as appropriate for the test system.
 For the neutralizer to be considered effective:
 Ensure that the recovered virus in the Titer Control using Test Suspension B is between approximately 2-3 logs per vessel.
 The recovered virus in the Neutralizer Effectiveness treatment is within 0.5 logs of the Titer Control; this verifies effective neutralization. A log reduction greater than 0.5 logs indicates that the neutralizer was not effective. Note: a value higher than the Titer Control is also deemed valid.
 The recovered virus in the Neutralizer Toxicity Control is within 0.5 logs of the Titer Control.  A log reduction greater than 0.5 logs indicates that the neutralizer is harmful to the test system. Note: a value higher than the Titer Control is also deemed valid.
 The recovered virus in the Carrier Interference Control is within 0.5 logs of the Titer Control.  A log reduction greater than 0.5 logs indicates that the carrier is harmful to the test system. Note: a value higher than the Titer Control is also deemed valid.
 All criteria in step e must be met. If the criteria are not met, another neutralizer or mixture of neutralizers must be identified and verified.

Attachment 2
                          Cytotoxicity Determination
Prior to performing the neutralization assay, ensure the proposed neutralizer, neutralizer and test chemical, and the soil used do not impact the quality of the cell line by performing the following.
 Neutralizer Effect on Cell Line (for neutralizers other than CGM with 2% CGM).
 Add 0.5 mL of the proposed neutralizer to 4.5 mL CGM with 2% (v/v) FBS, equilibrated to 37+-1°C (this is the 10[-1] dilution).  It is suggested to do further dilutions out to 10[-2] or 10[-3] depending on the expected cytotoxicity of the neutralizer.
 Remove the CGM from the wells of a 24 well plate with an 80-95% confluent monolayer of cells and add 1 mL per well of the neutralizer plus CGM solution. Plate at least 4 wells per dilution. Have at least one well as a negative control (e.g., CGM with 2% FBS alone).
 Incubate plate as appropriate and observe closely for cytotoxicity.
 If cytotoxicity is observed after one hour, remove the media in a single well of the affected dilution, rinse once with pre-warmed DPBS (the DPBS wash step may be omitted if the cytotoxicity is mild), and replace media.
 If cell death occurs in under one hour, the neutralizer cannot be tested.
 The effect of the media change in the single well can be compared to the other wells in the dilution and the negative control. If cytotoxicity cannot be overcome with washing and replacing of media, column filtration (e.g., Sephadex) may be used in future testing.
 Neutralizer Plus Test Chemical Effect on Cell Line.
 Add 50 uL of test chemical and 20 mL of neutralizer, equilibrated to 21+-3°C, and vortex 2-3 seconds. Let this solution sit at room temperature for 10 minutes.
 Add 1.0 mL of this solution to 9 mL CGM with 2% (v/v) FBS, equilibrated to 37+-1°C (this is the 10-1 dilution). It is suggested to do further dilutions out to 10-2 depending on the expected cytotoxicity.
 Remove the CGM from the wells of a 24 well plate with an 80-95% confluent monolayer of cells and add 1 mL per well of the neutralizer plus test chemical solution and dilutions. Plate at least 8 wells for the 100 dilution, 6 wells for the 10[-1] dilution, and 4 wells is for the 10[-2] dilution. Extra wells will be needed to observe the effect of no media changes or for further media changes as needed.
 For highly toxic test chemicals, washing the cells with pre-warmed DPBS before the addition of CGM with 2% FBS will help remove cytotoxicity.
 Have at least one well on each plate as a negative control (e.g., CGM with 2% (v/v) FBS alone).
 At a minimum, change the media in the wells as outlined below. Change the media at the lower time interval if they look more toxic. Other media changes can be made at other times if necessary.
 For the 10[0] dilution: On the day of the test, change 2 wells 1-2 hours (1-hour minimum) after the neutralizer/test chemical mixture was added to the cells. Change 2 more wells 3-5 hours after the neutralizer/test chemical mixture was added to the cells. The next day, change 1 each of the 1-2 hour and 3-5 hour wells, as well as another, previously unchanged well.
 For the 10[-1] dilution: On the day of the test, change 2 wells 3-5 hours after the neutralizer/test chemical mixture was added to the cells. The next day, change 1 of these wells as well as another, previously unchanged well.
 For the 10-2 dilution: On the day after the test, change 1 well.
 Incubate the plate as appropriate and observe the cells for cytotoxicity. The test cells should be compared to the negative control cells to determine toxicity.
 Score the cells as toxic or non-toxic in each in each test conditions.
 Identify the test condition that removed the cytotoxicity and use that condition for further neutralization and efficacy testing. Use the test condition that allows the media to stay on the cells for as long as possible.
 Example: In the 10[0] dilution, if the unchanged wells are toxic, but both the 1 hour and 4 hour media changes are non-toxic, change the media in the 100 dilutions after 4 hours in all future testing.
 If cell death occurs in under one hour, that test condition cannot be used.
 Cytotoxicity past the 10[-1] dilution is unacceptable for testing. Alternative neutralizers or column filtration (e.g., Sephadex) may be used to mitigate cytotoxicity. See ASTM Method E1482-12. Standard Practice for Use of Gel Filtration Columns for Cytotoxicity Reduction and Neutralization (Reapproved 2017) for further information on column filtration.
 3-Part Soil Effect on Cell Line.
 Make the 3-part soil (see section 14e but withhold the virus).
 Add 10 uL of the soil to 20 mL of CGM, equilibrated to 37+-1°C.
 Remove the CGM from the cells and add 1 mL of this solution to 4 wells on a 24 well plate with an 80-95% confluent monolayer of cells. Have at least one well as a negative control (e.g., CGM alone).
 Incubate plate as appropriate and observe daily for cytotoxicity. No cytotoxicity should be observed.

Attachment 3
                          Titer Interference Control
Add 50 uL of test substance to each vessel. At timed intervals add 10 mL neutralizer and swirl by hand.
                           Neutralizer Effectiveness
Add 10 uL of Test Suspension B to each vessel containing 50 uL test substance and 10 mL neutralizer.
Wait 10 s
Vortex and hold for 10 min at 21+-3°C. Proceed to vortexing/plating.
Treatment 1
 50 uL test substance
Add 10 uL of Test Suspension B to each vessel containing 10 mL neutralizer.
                         Neutralizer Toxicity Control
Vortex and hold for 10 min at 21+-3°C. Proceed to vortexing/plating.
Treatment 2
Add 10 uL of Test Suspension B to each vessel containing 10 mL PBS.
                                 Titer Control
Vortex and hold for 10 min at 21+-3°C. Proceed to vortexing/plating.
Treatment 3
Add 1 sterile carrier to each vessel. At timed intervals, add 10 mL neutralizer and swirl by hand.
Treatment 4
Add 10 uL of Test Suspension B to each vessel containing the carrier and 10 mL neutralizer.
Wait 10 s
Vortex and hold for 10 min at 21+-3°C. Proceed to vortexing/plating
Figure 2: Neutralization Schematic


[Federal Register Volume 77, Number 163 (Wednesday, August 22, 2012)]
[Notices]
[Pages 50701-50702]
[FR Doc No: 2012-20608]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0001]

Radiological Devices Panel of the Medical Devices Advisory
Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

    This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will
be open to the public.
    Name of Committee: Radiological Devices Panel of the Medical
Devices Advisory Committee.
    General Function of the Committee: To provide advice and
recommendations to the Agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on October 24, 2012, from 8
a.m. to 6 p.m.
    Location: Hilton Washington DC North/Gaithersburg, Salons A, B, C,
and D, 620 Perry Pkwy., Gaithersburg, MD 20877. The hotel's telephone
number is<PHONE_NUMBER>.
    Contact Person: Shanika Craig, Center for Devices and Radiological
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
66, Rm. 1613, Silver Spring, MD 20993<EMAIL_ADDRESS>301-
796-6639, or FDA Advisory Committee Information Line, 1-800-741-8138
(301-443-0572 in the Washington, DC area), to find out further
information regarding FDA advisory committee information. A notice in
the Federal Register about last minute modifications that impact a
previously announced advisory committee meeting cannot always be
published quickly enough to provide timely notice. Therefore, you
should always check the Agency's Web site at http://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate
advisory committee meeting link, or call the advisory committee
information line to learn about possible modifications before coming to
the meeting.
    Agenda: On October 24, 2012, the committee will discuss, make
recommendations, and vote on a premarket approval application
supplement to expand the indications for use of the Selenia Dimensions
3D System with C-View Software Module, sponsored by Hologic, Inc.
    The Selenia Dimensions 3D System is currently approved for breast
cancer screening and diagnosis. The screening exam can consist of field
digital mammography (FFDM) alone or the combination of FFDM with
digital breast tomosynthesis (DBT).
    The new C-View Software Module can generate synthetic 2D images
from the DBT data. Hologic requests to expand the indications for use
to allow the combination of DBT with synthetic 2D images to be used as
another exam option for breast cancer screening.
    FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its Web site prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's Web site after the meeting. Background material is
available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting
link.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person on or before
October 15, 2012. Oral presentations from the public will be scheduled
between approximately 1 p.m. and 2 p.m. Those individuals interested in
making formal oral presentations should notify the contact person and
submit a brief statement of the general nature of the evidence or
arguments they wish to present, the names and addresses of proposed
participants, and an indication of the approximate time requested to
make their presentation on or before October 5, 2012. Time allotted for
each presentation may be limited. If the number of registrants
requesting to speak is greater than can be reasonably accommodated
during the scheduled open public hearing session, FDA may conduct a
lottery to determine the speakers for the scheduled open public hearing
session. The contact person will notify interested persons regarding
their request to speak by October 9, 2012.
    Persons attending FDA's advisory committee meetings are advised
that the Agency is not responsible for providing access to electrical
outlets.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
physical disabilities or special needs. If you require special
accommodations due to a disability, please contact James Clark,
Conference Management Staff, at<EMAIL_ADDRESS>or 301-796-
5293, at least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: August 17, 2012.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2012-20608 Filed 8-21-12; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 82, Number 109 (Thursday, June 8, 2017)]
[Rules and Regulations]
[Pages 26571-26573]
[FR Doc No: 2017-11411]

========================================================================
Rules and Regulations
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains regulatory documents
having general applicability and legal effect, most of which are keyed
to and codified in the Code of Federal Regulations, which is published
under 50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by the Superintendent of Documents.

========================================================================

Federal Register / Vol. 82, No. 109 / Thursday, June 8, 2017 / Rules
and Regulations

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2017-0194; Directorate Identifier 2017-CE-006-AD;
Amendment 39-18915; AD 2017-11-16]
RIN 2120-AA64

Airworthiness Directives; PILATUS AIRCRAFT LTD. Airplanes

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Final rule.

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

SUMMARY: We are adopting a new airworthiness directive (AD) for PILATUS
AIRCRAFT LTD. Model PC-12/47E airplanes. This AD results from mandatory
continuing airworthiness information (MCAI) issued by an aviation
authority of another country to identify and correct an unsafe
condition on an aviation product. The MCAI describes the unsafe
condition as an error within the flight management system caused by
installing Primus APEX software Build 10 or 10.9, which could cause
deviation from the correctly calculated barometric vertical navigation
nominal glide path. We are issuing this AD to require actions to
address the unsafe condition on these products.

DATES: This AD is effective July 13, 2017.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in the AD as of July 13,
2017.

ADDRESSES: You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2017-
0194; or in person at Document Management Facility, U.S. Department of
Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590.
    For service information identified in this AD, contact PILATUS
AIRCRAFT LTD., Customer Support PC-12, CH-6371 Stans, Switzerland;
phone: +41 41 619 33 33; fax: +41 41 619 73 11; email:
<EMAIL_ADDRESS>Internet: www.pilatus-aircraft.com.
You may view this referenced service information at the FAA, Small
Airplane Directorate, 901 Locust, Kansas City, Missouri 64106. For
information on the availability of this material at the FAA, call (816)
329-4148. It is also available on the Internet at http://www.regulations.gov by searching for Docket No. FAA-2017-0194.

FOR FURTHER INFORMATION CONTACT: Doug Rudolph, Aerospace Engineer, FAA,
Small Airplane Directorate, 901 Locust, Room 301, Kansas City, Missouri
64106; telephone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 by adding an AD that would apply to PILATUS AIRCRAFT LTD. Model
PC-12/47E airplanes. The NPRM was published in the Federal Register on
March 21, 2017 (82 FR 14488). The NPRM proposed to correct an unsafe
condition for the specified products and was based on mandatory
continuing airworthiness information (MCAI) originated by an aviation
authority of another country. The MCAI states:

    An occurrence was reported of a split between the vertical
guidance data and the flight director steering commands during a
Vertical Glide Path (VGP) approach. Subsequent investigation
identified an error within the Flight Management System (FMS) that
was introduced into Primus APEX software (S/W) Build 10 and S/W
Build 10.9.
    This condition, if not corrected, could lead to loss of control
of the aeroplane.
    To address this potential unsafe condition, Pilatus issued
Temporary Revision (TR) No. 38 to the PC-12/47E Pilot's Operating
Handbook, (POH) Report No: 02277 (hereafter referred to as ``POH TR
38'' in this AD), limiting VGP Approach mode sourced on baro
Vertical Navigation (VNAV) to visual meteorological conditions (VMC)
only, and providing procedures applicable in case of VGP deviation
occurring during baro VNAV approaches.
    For the reason described above, this [EASA] AD requires
amendment of the applicable Aircraft Flight Manual (AFM).

    The MCAI can be found in the AD docket on the Internet at https://www.regulations.gov/document?D=FAA-2017-0194-0002.

Comments

    We gave the public the opportunity to participate in developing
this AD. The following presents the comment received on the proposal
and the FAA's response to the comment.

Request To Clarify the Unsafe Condition

    Johan Kruger of PILATUS AIRCRAFT LTD. stated that in the Discussion
section and the Reason section (paragraph (e)) of the proposed AD, it
is stated that the unsafe condition may result in loss of control due
to following incorrect data from the flight management system. The
commenter stated that the loss of control statement may be misleading.
    The commenter further stated that the autopilot fails to follow the
correctly indicated nominal vertical flight path. If the pilot does not
observe the indicated vertical deviation, which is the pilot's primary
duty during instrument meteorological conditions (IMC) final approach,
it could result in the pilot losing situational awareness. In a worst
case scenario, the airplane would descent towards terrain and
ultimately, if no attention is given to terrain awareness and warning
system (TAWS) call outs, collide with the terrain--potential controlled
flight into terrain (CFIT).
    The commenter requested that the last sentence of paragraph (e) be
changed to read: ``We are issuing this AD to prevent the pilot from
following incorrect data from the flight management system, which could
result in the loss of situational awareness.''
    We agree with the commenter and have changed the AD based on this
comment.

Conclusion

    We reviewed the relevant data, considered the comment received, and
determined that air safety and the public interest require adopting the
AD with the change described previously and minor editorial changes. We
have determined that these minor changes:

     [Agr]re consistent with the intent that was proposed in
the NPRM for correcting the unsafe condition; and
     Do not add any additional burden upon the public than was
already proposed in the NPRM.
    We also determined that these changes will not increase the
economic burden on any operator or increase the scope of the AD.

Related Service Information Under 1 CFR Part 51

    We reviewed PILATUS AIRCRAFT LTD. Temporary Revision No. 38 to PC-
12/47E Pilot's Operating Handbook, Airplane Flight Manual 02277,
Section 2--Limitations, Report No: 02277, dated February 8, 2017. The
service information describes procedures for limiting the use of the
autopilot and flight director to day visual meteorological conditions
(VMC) during barometric vertical navigation (baro VNAV) during a
vertical glide path approach (VGP). This service information is
reasonably available because the interested parties have access to it
through their normal course of business or by the means identified in
the ADDRESSES section of this AD.

Costs of Compliance

    We estimate that this AD will affect 350 products of U.S. registry.
We also estimate that it will take about 1 work-hour per product to
comply with the basic requirements of this AD. The average labor rate
is $85 per work-hour.
    Based on these figures, we estimate the cost of this AD on U.S.
operators to be $29,750, or $85 per product.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. ``Subtitle VII: Aviation
Programs,'' describes in more detail the scope of the Agency's
authority.
    We are issuing this rulemaking under the authority described in
``Subtitle VII, Part A, Subpart III, section 44701: General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    We determined that this AD will not have federalism implications
under Executive Order 13132. This AD will not have a substantial direct
effect on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government.
    For the reasons discussed above, I certify this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979),
    (3) Will not affect intrastate aviation in Alaska, and
    (4) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2017-
0194; or in person at the Docket Management Facility between 9 a.m. and
5 p.m., Monday through Friday, except Federal holidays. The AD docket
contains the NPRM, the regulatory evaluation, any comments received,
and other information. The street address for the Docket Office
(telephone<PHONE_NUMBER>) is in the ADDRESSES section. Comments will
be available in the AD docket shortly after receipt.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

Adoption of the Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

     Authority: 49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13   [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new AD:

2017-11-16 PILATUS AIRCRAFT LTD.: Amendment 39-18915; Docket No.
FAA-2017-0194; Directorate Identifier 2017-CE-006-AD.

(a) Effective Date

    This airworthiness directive (AD) becomes effective July 13,
2017.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to PILATUS AIRCRAFT LTD. Model PC-12/47E
airplanes, all serial numbers, that:
    (1) Have Primus APEX Software Build 10 with Honeywell part
number (P/N) EB60000487-0110 or Primus APEX Software Build 10.9 with
Honeywell P/N EB60000487-0112 installed; and
    (2) are certificated in any category.

(d) Subject

    Air Transport Association of America (ATA) Code 34: Navigation.

(e) Reason

    This AD was prompted by mandatory continuing airworthiness
information (MCAI) originated by an aviation authority of another
country to identify and correct an unsafe condition on an aviation
product. The MCAI describes the unsafe condition as an error within
the flight management system caused by installing Primus APEX
software Build 10 or 10.9, which could cause deviation from the
correctly calculated barometric vertical navigation nominal guide
path. We are issuing this AD to prevent the pilot from following
incorrect data from the flight management system, which could result
in the loss of situational awareness.

(f) Actions and Compliance

    Unless already done, within 30 days after July 13, 2017 (the
effective date of this AD), insert Temporary Revision No. 38 to PC-
12/47E Pilot's Operating Handbook, Airplane Flight Manual 02277,
Section 2--Limitations, Report No: 02277, dated February 8, 2017.

    Note 1 to paragraph (f) of this AD: For airplanes affected by
this AD, the Pilot's Operating Handbook and the Airplane Flight
Manual are the same document with the Report No.: 02277.

(g) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
Standards Office, FAA, has the authority to approve AMOCs for this
AD, if requested using the procedures found in 14 CFR 39.19. Send
information to ATTN: Doug Rudolph, Aerospace Engineer, FAA, Small
Airplane Directorate, 901 Locust, Room 301, Kansas City, Missouri
64106; telephone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>Before using any approved AMOC on any airplane
to which the AMOC applies, notify your appropriate principal
inspector (PI) in the FAA Flight Standards District Office (FSDO),
or lacking a PI, your local FSDO.
    (2) Airworthy Product: For any requirement in this AD to obtain
corrective actions from a manufacturer or other source, use these
actions if they are FAA-approved. Corrective actions are considered
FAA-approved if they are approved by the State of Design Authority

(or their delegated agent). You are required to assure the product
is airworthy before it is returned to service.

(h) Related Information

    Refer to MCAI European Aviation Safety Agency (EASA) AD No.
2017-0024, dated February 13, 2017, for related information. The
MCAI can be found in the AD docket on the Internet at https://www.regulations.gov/document?D=FAA-2017-0194-0002.

(i) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless the AD specifies otherwise.
    (i) Temporary Revision No. 38 to PC-12/47E Pilot's Operating
Handbook, Airplane Flight Manual 02277, Section 2--Limitations,
Report No: 02277, dated February 8, 2017.
    (ii) Reserved.
    (3) For PILATUS AIRCRAFT LTD. service information identified in
this AD, contact PILATUS AIRCRAFT LTD., Customer Support PC-12, CH-
6371 Stans, Switzerland; phone: +41 41 619 33 33; fax: +41 41 619 73
11; email<EMAIL_ADDRESS>Internet: www.pilatus-
aircraft.com.
    (4) You may view this service information at the FAA, Small
Airplane Directorate, 901 Locust, Kansas City, Missouri 64106. For
information on the availability of this material at the FAA, call
(816) 329-4148. In addition, you can access this service information
on the Internet at http://www.regulations.gov by searching for and
locating Docket No. FAA-2017-0194.
    (5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Kansas City, Missouri, on May 26, 2017.
Pat Mullen,
Acting Manager, Small Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2017-11411 Filed 6-7-17; 8:45 am]
BILLING CODE 4910-13-P