[Federal Register Volume 80, Number 61 (Tuesday, March 31, 2015)]
[Notices]
[Pages 17129-17132]
[FR Doc No: 2015-07252]

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SECURITIES AND EXCHANGE COMMISSION

[Investment Company Act Release No. 31511; File No. 812-14346]

ETFS Trust and ETF Securities Advisors, LLC; Notice of
Application

March 25, 2015.
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 of Application:  Applicants request an order that would permit
them to enter into and materially amend subadvisory agreements with
Wholly-Owned Sub-Advisers (as defined below) and non-affiliated sub-
advisers without shareholder approval and would grant relief from
certain disclosure requirements.

Applicants: ETFS Trust (the ``Trust'') and ETF Securities Advisors LLC
(the ``Adviser'').

DATES: Filing Dates: The application was filed on August 13, 2014 and
amended on December 2, 2014 and February 12, 2015.

Hearing or Notification of Hearing: An order granting the requested
relief will be issued unless the Commission orders a hearing.
Interested persons may request a hearing by writing to the Commission's
Secretary and serving applicants with a copy of the request, personally
or by mail. Hearing requests should be received by the Commission by
5:30 p.m. on April 17, 2015, and should be accompanied by proof of
service on applicants, in the form of an affidavit or, for lawyers, a
certificate of service. Pursuant to rule 0-5 under the Act, hearing
requests should state the nature of the writer's interest, any facts
bearing upon the desirability of a hearing on the matter, the reason
for the request, and the issues contested. Persons who wish to be
notified of a hearing may request notification by writing to the
Commission's Secretary.

ADDRESSES: Secretary, U.S. Securities and Exchange Commission, 100 F
Street NE., Washington, DC 20549-1090. Applicants, ETFS Trust, 48 Wall
Street, New York, New York 10005.

FOR FURTHER INFORMATION CONTACT: Barbara T. Heussler, Senior Counsel,
at<PHONE_NUMBER>, or Mary Kay Frech, 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. The Trust is organized as a Delaware statutory trust and is
registered with the Commission as an open-end management investment
company under the Act. The Trust currently offers four series of shares
and may offer additional series of shares in the future (each, a
``Fund'' and collectively the ``Funds''),\1\ each with its own distinct
investment objective, policy and restrictions. Each Fund will operate
as an exchange-traded fund.\2\ ETF Securities is a Delaware limited
liability company and is registered with the Commission as an
investment adviser under the Investment Advisers Act of 1940 (the
``Advisers Act'').
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    \1\ Currently the Trust consists of the following Funds: ETFS
Zacks Earnings Large-Cap U.S. Index Fund, ETFS Zacks Earnings Small-
Cap U.S. Index Fund, ETFS Diversified-Factor Large Cap U.S. Index
Fund, and the ETFS Diversified-Factor Developed Europe Index Fund
(the ``Initial Fund(s)'').
    \2\ Future Funds may be operated as a master-feeder structure
pursuant to section 12(d)(1)(E) of the Act. In such a structure,
certain Funds (each, a ``Feeder Fund'') may invest substantially all
of their assets in a Fund (a ``Master Fund'') pursuant to section
12(d)(1)(E) of the Act. No Feeder Fund will engage any sub-advisers
other than through approving the engagement of one or more of the
Master Fund's sub-advisers.
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    2. Applicants request an order to permit the Adviser,\3\ subject to
the

approval of the board of trustees of the Trust (the ``Board''),
including a majority of the trustees who are not ``interested persons''
of the Trust, the Funds or the Adviser as defined in section 2(a)(19)
of the Act (the ``Independent Trustees''), to, without obtaining
shareholder approval: (a) Select Sub-Advisers \4\ to manage all or a
portion of the assets of a Fund and enter into investment sub-advisory
agreements with the Sub-Advisers (each, a ``Sub-Advisory Agreement'');
and (b) materially amend Sub-Advisory Agreements with the Sub-
Advisers.\5\ Applicants request that the relief apply to the named
applicants, as well as to any future Fund and any other existing or
future registered open-end management investment company or series
thereof that is advised by the Adviser, uses the multi-manager
structure described in the application, and complies with the terms and
conditions set forth in the application (each, a ``Subadvised
Fund'').\6\ The requested relief will not extend to any sub-adviser,
other than a Wholly-Owned Sub-Adviser, who is an affiliated person, as
defined in section 2(a)(3) of the Act, of the Subadvised Fund, of any
Feeder Fund, or of the Adviser, other than by reason of serving as a
sub-adviser to one or more of the Subadvised Funds (``Affiliated Sub-
Adviser'').
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    \3\ The term ``Adviser'' includes (1) ETF Securities, and (2)
any entity controlling, controlled by or under common control with,
ETF Securities or its successors that serves as investment adviser
to the Funds. 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.
    \4\ A ``Sub-Adviser'' for a Fund is (1) an indirect or direct
``wholly owned subsidiary'' (as such term is defined in the Act) of
the Adviser for that Fund, or (2) a sister company of the Adviser
for that Fund that is an indirect or direct ``wholly-owned
subsidiary'' of the same company that, indirectly or directly,
wholly owns the Adviser (each of (1) and (2) a ``Wholly-Owned Sub-
Adviser'' and collectively, the ``Wholly-Owned Sub-Advisers''), or
(3) not an ``affiliated person'' (as such term is defined in section
2(a)(3) of the Act) of the Fund, any Feeder Fund invested in a
Master Fund, the Trust, or the Adviser, except to the extent that an
affiliation arises solely because the Sub-Adviser serves as a sub-
adviser to a Fund (each, a ``Non-Affiliated Sub-Adviser'').
    \5\ Shareholder approval will continue to be required for any
other sub-adviser changes (not otherwise permitted by rule) and
material amendments to an existing Sub-Advisory Agreement with any
sub-adviser other than a Non-Affiliated Sub-Adviser or Wholly-Owned
Sub-Adviser (all such changes referred to as ``Ineligible Sub-
Adviser Changes'').
    \6\ All registered open-end investment companies that currently
intend to rely on the requested order are named as applicants. All
Funds that currently are, or that currently intend to be, Subadvised
Funds 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 in the application. If the name of any
Subadvised Fund contains the name of a Sub-Adviser, the name of the
Adviser that serves as the primary adviser to the Subadvised Fund,
or a trademark or trade name that is owned by or publicly used to
identify that Adviser, will precede the name of the Sub-Adviser.
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    3. ETF Securities is the investment adviser to each Fund pursuant
to an investment advisory agreement with the Trust (the ``Investment
Management Agreement''). Any other Adviser will be registered with the
Commission as an investment adviser under the Advisers Act. The
Investment Management Agreement was approved by the Board, including a
majority the Independent Trustees, and by the shareholders of each Fund
in the manner required by sections 15(a) and 15(c) of the Act and rule
18f-2 thereunder. The terms of the Investment Management Agreement will
comply with section 15(a) of the Act. Each other investment management
agreement with respect to a Fund (included in the term ``Investment
Management Agreement'') will comply with section 15(a) of the Act and
will be similarly approved.
    4. Pursuant to the terms of the Investment Management Agreement,
the Adviser, subject to the supervision of the Board, provides
continuous investment management of the assets of each Fund. Consistent
with the terms of the Investment Management Agreement, the Adviser may,
subject to the approval of the Board, including a majority of the
Independent Trustees, and the shareholders of the applicable Subadvised
Fund (if required), delegate portfolio management responsibilities of
all or a portion of the assets of a Subadvised Fund to one or more Sub-
Advisers. The Adviser would continue to have overall responsibility for
the management and investment of the assets of each Subadvised Fund,
and the Adviser's responsibilities would include, for example,
recommending the removal or replacement of Sub-Advisers and determining
the portion of that Subadvised Fund's assets to be managed by any given
Sub-Adviser and reallocating those assets as necessary from time to
time. The Adviser evaluates, allocates assets to, and oversees, the
Sub-Advisers, and makes recommendations about their hiring, termination
and replacement to the Board, at all times subject to the authority of
the Board. For its services to a Fund under an Investment Management
Agreement, the Adviser would receive an investment management fee from
that Fund based on the average net assets of that Fund.
    5. Currently the Adviser has entered into a sub-advisory agreement
with Index Management Solutions, LLC (``IMS'') with respect to the
Initial Funds. The sub-advisory agreement with IMS was approved by the
Board, including a majority of the Independent Trustees, and by the
sole shareholders of each Initial Fund in the manner required by
sections 15(a) and 15(c) of the Act and rule 18f-2 thereunder. The
terms of the sub-advisory agreement with IMS comply with section 15(a)
of the Act. IMS is, and any future Sub-Adviser will be, an ``investment
adviser'' as defined in section 2(a)(20) of the Act and will be
registered as an investment adviser under the Advisers Act or exempt
from such registration. Any Sub-Advisory Agreements will be approved by
the Board, including a majority of the Independent Trustees, and the
terms of each Sub-Advisory Agreement will comply fully with the
requirements of section 15(a) of the Act. The Sub-Advisers, subject to
the supervision of the Adviser and oversight of the Board, determine
the securities and other instruments to be purchased, sold or entered
into by a Subadvised Fund's portfolio or a portion thereof, and place
orders with brokers or dealers that they select. The Adviser will
compensate each Sub-Adviser out of the fee paid to the Adviser under
the Investment Management Agreement.
    6. Subadvised Funds will inform shareholders of the hiring of a new
Sub-Adviser pursuant to the following procedures (``Modified Notice and
Access Procedures''): (a) Within 90 days after a new Sub-Adviser is
hired for any Subadvised Fund, that Subadvised Fund will send its
shareholders \7\ either a Multi-manager Notice or a Multi-manager
Notice and Multi-manager Information Statement; \8\ and (b) the
Subadvised Fund 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. Applicants state that, in the circumstances described in
the application, a proxy solicitation to approve the appointment of new
Sub-Advisers provides no more meaningful information to shareholders
than the proposed Multi-manager Information Statement. Applicants also
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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    \7\ If the Subadvised Fund is a Master Fund, for purposes of the
Modified Notice and Access Procedures, ``shareholders'' include both
the shareholders of the applicable Master Fund and the shareholders
of its Feeder Funds.
    \8\ 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-Adviser; (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 Fund.
    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. Multi-
manager Information Statements will be filed with the Commission via
the EDGAR system.
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    7. Applicants also request an order under section 6(c) of the Act
exempting the Subadvised Funds from certain disclosure obligations that
may require each Subadvised Fund to disclose fees paid by the Adviser
to each Sub-Adviser. Applicants seek relief to permit each Subadvised
Fund to disclose (as a dollar amount and a percentage of the Subadvised
Fund's net assets): (a) The aggregate fees paid to the Adviser and any
Wholly-Owned Sub-Advisers; (b) the aggregate fees paid to Non-
Affiliated Sub-Advisers; and (c) the fee paid to each Affiliated Sub-
Adviser (collectively, the ``Aggregate Fee Disclosure''). An exemption
is requested to permit the Funds 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.

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 provides that each series or class
of stock in a series investment company affected by a matter must
approve that matter if the Act requires shareholder approval.
    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 investment company
registration statements and shareholder reports filed with the
Commission. Sections 6-07(2)(a), (b) and (c) of Regulation S-X require
registered investment companies to include in their financial
statements information about 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 Adviser,
subject to the review and approval of the Board, to select the Sub-
Advisers who are in the best position to achieve the Subadvised Funds'
investment objectives. Applicants assert that, from the perspective of
the shareholder, the role of the Sub-Advisers 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 Adviser to perform the duties for which the
shareholders of the Subadvised Fund are paying the Adviser--the
selection, supervision and evaluation of the Sub-Advisers--without
incurring unnecessary delays or expenses is appropriate in the interest
of the Subadvised Fund's shareholders and will allow such Subadvised
Fund to operate more efficiently. Applicants state that the 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 Board,
including a majority of the Independent Trustees, 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
Agreement.
    7. Applicants assert that disclosure of the individual fees that
the Adviser would pay to the Sub-Advisers of Subadvised Funds that
operate in the multi-manager structure described in the application
does not serve any meaningful purpose. Applicants contend that the
primary reasons for requiring disclosure of individual fees paid to
Sub-Advisers are to inform shareholders of expenses to be charged by a
particular Subadvised Fund 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 Adviser will be fully disclosed and,
therefore, shareholders will know what the Subadvised Fund's fees and
expenses are and will be able to compare the advisory fees a Subadvised
Fund is charged to those of other investment companies. Applicants
assert that the requested disclosure relief would benefit shareholders
of the Subadvised Fund because it would improve the Adviser's ability
to negotiate the fees paid to Sub-Advisers. Applicants state that if
the Adviser is not required to disclose the Sub-Advisers' fees to the
public, the Adviser may be able to negotiate rates that are below a
Sub-Adviser's ``posted'' amounts. Applicants assert that the relief
will also encourage Sub-Advisers to negotiate lower sub-advisory fees
with the Adviser if the lower fees are not required to be made public.
    8. Applicants submit that the requested relief meets the standards
for relief under section 6(c) of the Act. Applicants state that each
Subadvised Fund will be required to obtain shareholder approval to
operate as a ``multiple manager'' fund as described in the application
before relying on the requested order. Applicants assert that
conditions 6, 10, and 11 are designed to provide the Board with
sufficient independence and the resources and information it needs to
monitor and address any conflicts of interest. 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: \9\
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    \9\ Applicants will only comply with conditions 7, 8, 9, and 12
if they rely on the relief that would allow them to provide
Aggregate Fee Disclosure.
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    1. Before a Subadvised Fund may rely on the order requested in the
application, the operation of the Subadvised Fund in the manner
described in the application, including the hiring of Wholly-Owned Sub-
Advisers, will be approved by a majority of the Subadvised Fund's
outstanding voting securities as defined in the Act, which in the case
of a Master Fund will include voting instructions provided by
shareholders of the Feeder Funds investing in such Master Fund or other
voting arrangements that comply with section 12(d)(1)(E)(iii)(aa) of
the Act or, in the case of a new Subadvised Fund whose public
shareholders purchase shares on the basis of a prospectus containing
the disclosure contemplated by condition 2 below, by the initial
shareholder(s) before offering the Subadvised Fund's shares to the
public.
    2. The prospectus for each Subadvised Fund, and in the case of a
Master Fund relying on the requested relief, the prospectus for each
Feeder Fund investing in such Master Fund, will disclose the existence,
substance and effect of any order granted pursuant to the application.
Each Subadvised Fund (and any such Feeder Fund) will hold itself out to
the public as employing the multi-manager structure described in the
application. Each prospectus will prominently disclose that the Adviser
has the ultimate responsibility, subject to oversight by the Board, to
oversee the Sub-Advisers and recommend their hiring, termination, and
replacement.
    3. The Adviser will provide general management services to a
Subadvised Fund, including overall supervisory responsibility for the
general management and investment of the Subadvised Fund's assets.
Subject to review and approval of the Board, the Adviser will (a) set a
Subadvised Fund's overall investment strategies, (b) evaluate, select,
and recommend Sub-Advisers to manage all or a portion of a Subadvised
Fund's assets, and (c) implement procedures reasonably designed to
ensure that Sub-Advisers comply with a Subadvised Fund's investment
objective, policies and restrictions. Subject to review by the Board,
the Adviser will (a) when appropriate, allocate and reallocate a
Subadvised Fund's assets among Sub-Advisers; and (b) monitor and
evaluate the performance of Sub-Advisers.
    4. A Subadvised Fund will not make any Ineligible Sub-Adviser
Changes without such agreement, including the compensation to be paid
thereunder, being approved by the shareholders of the applicable
Subadvised Fund, which in the case of a Master Fund will include voting
instructions provided by shareholders of the Feeder Fund investing in
such Master Fund or other voting arrangements that comply with section
12(d)(1)(E)(iii)(aa) of the Act.
    5. Subadvised Funds will inform shareholders, and if the Subadvised
Fund is a Master Fund, shareholders of any Feeder Funds, of the hiring
of a new Sub-Adviser within 90 days after the hiring of the new Sub-
Adviser pursuant to the Modified Notice and Access Procedures.
    6. At all times, at least a majority of the Board will be
Independent Trustees, and the selection and nomination of new or
additional Independent Trustees will be placed within the discretion of
the then-existing Independent Trustees.
    7. Independent Legal Counsel, as defined in rule 0-1(a)(16) under
the Act, will be engaged to represent the Independent Trustees. The
selection of such counsel will be within the discretion of the then-
existing Independent Trustees.
    8. The Adviser will provide the Board, no less frequently than
quarterly, with information about the profitability of the Adviser on a
per Subadvised Fund basis. The information will reflect the impact on
profitability of the hiring or termination of any sub-adviser during
the applicable quarter.
    9. Whenever a sub-adviser is hired or terminated, the Adviser will
provide the Board with information showing the expected impact on the
profitability of the Adviser.
    10. Whenever a sub-adviser change is proposed for a Subadvised Fund
with an Affiliated Sub-Adviser or a Wholly-Owned Sub-Adviser, the
Board, including a majority of the Independent Trustees, will make a
separate finding, reflected in the Board minutes, that such change is
in the best interests of the Subadvised Fund and its shareholders, and
if the Subadvised Fund is a Master Fund, the best interests of any
applicable Feeder Funds and their respective shareholders, and does not
involve a conflict of interest from which the Adviser or the Affiliated
Sub-Adviser or Wholly-Owned Sub-Adviser derives an inappropriate
advantage.
    11. No Trustee or officer of the Trust, a Fund or a Feeder Fund, or
partner, director, manager or officer of the Adviser, will own directly
or indirectly (other than through a pooled investment vehicle that is
not controlled by such person) any interest in a Sub-Adviser except for
(a) ownership of interests in the Adviser or any entity, except a
Wholly-Owned Sub-Adviser, that controls, is controlled by, or is under
common control with the Adviser, or (b) ownership of less than 1% of
the outstanding securities of any class of equity or debt of any
publicly traded company that is either a Sub-Adviser or an entity that
controls, is controlled by, or under common control with a Sub-Adviser.
    12. Each Subadvised Fund and any Feeder Fund that invests in a
Subadvised Fund that is a Master Fund will disclose the Aggregate Fee
Disclosure in its registration statement.
    13. Any new Sub-Advisory Agreement or any amendment to a Subadvised
Fund's existing Investment Management Agreement or Sub-Advisory
Agreement that directly or indirectly results in an increase in the
aggregate advisory fee rate payable by the Subadvised Fund will be
submitted to the Subadvised Fund's shareholders for approval.
    14. 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.
Brent J. Fields,
Secretary.
[FR Doc. 2015-07252 Filed 3-30-15; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 83, Number 188 (Thursday, September 27, 2018)]
[Notices]
[Pages 48825-48826]
[FR Doc No: 2018-21042]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-1752]

Public Availability of Lists of Retail Consignees To Effectuate
Certain Human and Animal Food Recalls; Draft Guidance for Industry and
Food and Drug Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA, we, or Agency) is
announcing the availability of a draft guidance for industry and FDA
staff entitled ``Public Availability of Lists of Retail Consignees to
Effectuate Certain Human and Animal Food Recalls.'' The draft guidance,
when finalized, establishes guidance for industry and FDA staff on how
and when FDA intends to collect, compile, and publicize retail
consignees that may have received recalled foods. While FDA intends to
focus on recalls where there is a reasonable probability that the use
of, or exposure to, the food will cause serious adverse health
consequences or death to humans or animals (Class I recalls), FDA may
also publicize retail consignee lists for other food recalls as
described in the draft guidance. FDA's goal is to publicize retail
consignee lists for these food recalls where providing this additional
information will be of the most use to consumers to help them identify
recalled food and to determine whether that food is in their possession
as effectively and quickly as possible.

DATES: Submit either electronic or written comments on the draft
guidance by November 26, 2018 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted,

such as medical information, your or anyone else's Social Security
number, or confidential business information, such as a manufacturing
process. Please note that if you include your name, contact
information, or other information that identifies you in the body of
your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2018-D-1752 for ``Public Availability of Lists of Retail Consignees
to Effectuate Certain Human and Animal Food Recalls; Draft Guidance for
Industry and FDA Staff.'' Received comments will be placed in the
docket and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the draft guidance to
the Office of Strategic Planning and Operational Policy, Office of
Regulatory Affairs, Food and Drug Administration, 12420 Parklawn Dr.,
Element Building, Rockville, MD 20857. Send one self-addressed adhesive
label to assist that office in processing your requests. See the
SUPPLEMENTARY INFORMATION section for electronic access to the draft
guidance document.

FOR FURTHER INFORMATION CONTACT: Chris Henderson, Office of Regulatory
Affairs, Division of Operational Policy, Food and Drug Administration,
12420 Parklawn Dr., Rockville, MD 20857,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
and FDA staff entitled ``Public Availability of Lists of Retail
Consignees to Effectuate Certain Human and Animal Food Recalls.'' The
draft guidance, when finalized, establishes guidance for industry and
FDA staff on how and when FDA intends to publicize retail consignees
that may have received recalled foods. FDA's goal is to publicize
retail consignee lists for these food recalls, especially those that
are likely to be classified as Class I recalls, where providing this
additional information will be of the most use to consumers to help
them identify recalled food and to determine whether that food is in
their possession as effectively and quickly as possible. FDA seeks
comment on this draft guidance, including scope of the term ``retail
consignee'' as used in this document, the situations where providing
retail consignee lists would be of the most use to consumers to
identify recalled food in their possession, and additional information
that would be of the most use to consumers to help them identify
recalled food in their possession.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA regarding
publicizing retail consignees to effectuate certain food recalls. It
does not establish any rights for any person and is not binding on FDA
or the public. You can use an alternative approach if it satisfies the
requirements of the applicable statutes and regulations. This draft
guidance is not subject to Executive Order 12866.

II. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). Any
collections of information under 21 CFR 7.46, 7.49, 7.53, 7.55, and
7.59 have been approved under OMB control number 0910-0249.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance
at either https://www.fda.gov/Safety/Recalls/default.htm or https://www.regulations.gov.

    Dated: September 21, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-21042 Filed 9-26-18; 8:45 am]
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[Federal Register Volume 86, Number 29 (Tuesday, February 16, 2021)]
[Notices]
[Pages 9513-9514]
[FR Doc No: 2021-03066]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-0008]

General and Plastic Surgery Devices Panel of the Medical Devices
Advisory Committee, Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) announces
a forthcoming public advisory committee meeting of the General and
Plastic Surgery Devices Panel of the Medical Devices Advisory
Committee. The general function of the committee is to provide advice
and recommendations to the Agency on FDA's regulatory issues. The
meeting will be open to the public.

DATES: The meeting will take place virtually on March 23, 2021, from 9
a.m. Eastern Time to 6 p.m. Eastern Time.

ADDRESSES: Please note that due to the impact of this COVID-19
pandemic, all meeting participants will be joining this advisory
committee meeting via an online teleconferencing platform. Answers to
commonly asked questions about FDA advisory committee meetings may be
accessed at: https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.

FOR FURTHER INFORMATION CONTACT: Patricio Garcia, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 5216, Silver Spring, MD 20993-0002,
<EMAIL_ADDRESS>301-796-6875, or FDA Advisory Committee
Information Line, 1-800-741-8138<PHONE_NUMBER> in the Washington, DC
area). 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 website at: https://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 the
meeting.

SUPPLEMENTARY INFORMATION:
    Agenda: The meeting presentations will be heard, viewed, captioned,
and recorded through an online teleconferencing platform. On March 23,
2021, the committee will discuss and make recommendations regarding the
benefits and risks of dermal fillers concerning the following topics:
(1) Risks associated with intravascular injection of dermal fillers and
(2) patient preference and informed decision making. FDA is convening
this meeting to seek expert opinion on the clinical evaluation and
regulation of dermal filler products.
    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 website prior to the meeting, the
background material will be made publicly available on FDA's website at
the time of the advisory committee meeting, and the background

material will be posted on FDA's website after the meeting. Background
material and the link to the online teleconference meeting room will be
available at: https://www.fda.gov/advisory-committees/medical-devices-advisory-committee/general-and-plastic-surgery-devices-panel. Select
the link for the 2021 Meeting Materials. The meeting will include slide
presentations with audio components to allow the presentation of
materials in a manner that most closely resembles an in-person advisory
committee meeting.
    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
March 9, 2021. Oral presentations from the public and organizations
will be scheduled on March 23, 2021, between approximately 12:40 p.m.
Eastern Time to 1:40 p.m. Eastern Time. Those individuals interested in
making formal oral presentations should notify the contact person (see
FOR FURTHER INFORMATION CONTACT). The notification should include 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 March 11, 2021. 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 sessions.
The contact person will notify interested persons regarding their
request to speak by March 12, 2021.
    For press inquiries, please contact the Office of Media Affairs at
<EMAIL_ADDRESS>or<PHONE_NUMBER>.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
disabilities. If you require accommodations due to a disability, please
contact Artair Mallet at<EMAIL_ADDRESS>or<PHONE_NUMBER> at
least 7 days in advance of the meeting. FDA is committed to the orderly
conduct of its advisory committee meetings. Please visit our website
at: https://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: February 9, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-03066 Filed 2-12-21; 8:45 am]
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[Federal Register Volume 79, Number 74 (Thursday, April 17, 2014)]
[Proposed Rules]
[Pages 21651-21655]
[FR Doc No: 2014-08727]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2014-0236; Directorate Identifier 2013-NM-184-AD]
RIN 2120-AA64

Airworthiness Directives; Airbus Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: We propose to adopt a new airworthiness directive (AD) for all
Airbus Model A300 series airplanes. This proposed AD was prompted by
our determination of the need to incorporate new life limits for the
main landing gear (MLG) barrel assembly, retraction actuator assembly
linkage, and flange duct. This proposed AD would require revising the
maintenance or inspection program to include the new life limits. We
are proposing this AD to prevent reduced structural integrity of the
airplane and possible loss of controllability of the airplane.

DATES: We must receive comments on this proposed AD by June 2, 2014.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.
    For service information identified in this proposed AD, contact
Airbus SAS, Airworthiness Office--EAW, 1 Rond Point Maurice Bellonte,
31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5 61
93 44 51; email<EMAIL_ADDRESS>Internet http://www.airbus.com. You may view this service information at the FAA,
Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For
information on the availability of this material at the FAA, call 425-
227-1221.

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-2014-
0236; 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 this proposed AD, the regulatory evaluation, any comments
received, and other information. The street address for the Docket
Operations office (telephone<PHONE_NUMBER>) is in the ADDRESSES
section. Comments will be available in the AD docket shortly after
receipt.

FOR FURTHER INFORMATION CONTACT: Dan Rodina, Aerospace Engineer,
International Branch, ANM 116, Transport Airplane Directorate, FAA,
1601 Lind Avenue SW., Renton, WA 98057-3356; telephone<PHONE_NUMBER>;
fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2014-0236;
Directorate Identifier 2013-NM-184-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD based on those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this proposed AD.

Discussion

    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Community, has issued EASA
Airworthiness Directive 2013-0210, dated September 11, 2013 (referred
to after this as the Mandatory Continuing Airworthiness Information, or
``the MCAI''), to correct an unsafe condition for the specified
products. The MCAI states:

    Some life limits previously defined in Revision 00 of A300 ALS
[airworthiness limitations section] Part 1 have been removed [from]
that document at Revision 01 and should normally be included in an
ALS Part 4.
    At this time, there are no plans to issue an ALS Part 4 for A300
aeroplanes.
    Nevertheless, failure to comply with these life limits could
result in an unsafe condition.
    For the reasons described above, it has been decided to require
the application of these life limits through a separate [EASA] AD.
Consequently, this [EASA] AD requires application of life limits
applicable to Main Landing Gear (MLG) barrel assembly, retraction
actuator assembly linkage assembly and flanged duct which were
previously contained in Airbus ALS Part 1 Revision 00.
    EASA AD 2007-0293 [which corresponds with FAA AD 2009-18-15,
Amendment 39-16011 (74 FR 48143, September 22, 2009)], which
required compliance with the actions specified in ALS Part 1, will
be superseded by a new [EASA] AD, requiring compliance with ALS Part
1 at Revision 1.

    You may examine the MCAI in the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2014-
0236.

FAA's Determination and Requirements of This Proposed AD

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to our bilateral agreement with the State of Design Authority, we have
been notified of the unsafe condition described in the MCAI and service
information referenced above. We are proposing this AD because we
evaluated all pertinent information and determined an unsafe condition
exists and is likely to exist or develop on other products of the same
type design.
    This AD requires revisions to certain operator maintenance
documents to include new actions (e.g., inspections). Compliance with
these actions is required by 14 CFR 91.403(c). For airplanes that have
been previously modified, altered, or repaired in the areas addressed
by this proposed AD, the operator may not be able to accomplish the
actions described in the revisions. In this situation, to comply with
14 CFR 91.403(c), the operator must request approval for an alternative
method of compliance according to the procedures specified in paragraph
(i)(1) of this AD. The request should include a description of changes
to the required

inspections that will ensure the continued operational safety of the
airplane.

Costs of Compliance

    We estimate that this proposed AD affects 7 airplanes of U.S.
registry.
    We also estimate that it would take about 1 work-hour per product
to comply with the basic requirements of this proposed AD. The average
labor rate is $85 per work-hour. Based on these figures, we estimate
the cost of this proposed AD on U.S. operators to be $595, 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 proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would 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 proposed
regulation:
    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.

List of Subjects in 14 CFR Part 39

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

The Proposed Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA proposes to amend 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 airworthiness
directive (AD):

Airbus: Docket No. FAA-2014-0236; Directorate Identifier 2013-NM-
184-AD.

(a) Comments Due Date

    We must receive comments by June 2, 2014.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to all Airbus Model A300 B2-1A, B2-1C, B2K-3C,
B2-203, B4-2C, B4-103, and B4-203 airplanes, certificated in any
category.

(d) Subject

    Air Transport Association (ATA) of America Code 32, Landing
Gear; 36, Pneumatic.

(e) Reason

    This AD was prompted by our determination of the need to
incorporate new life limits for the main landing gear (MLG) barrel
assembly, retraction actuator assembly linkage, and flange duct. We
are issuing this AD to prevent reduced structural integrity of the
airplane and possible loss of controllability of the airplane.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Revise the Maintenance or Inspection Program

    Within 90 days after the effective date of this AD, revise the
maintenance or inspection program, as applicable, to incorporate the
life limits specified in Appendix 1 of this AD into the Airbus A300
ALS Part 1. The initial compliance time for the replacement is
identified in Appendix 1 of this AD and is prior to the applicable
life limits specified in Appendix 1 of this AD or within 90 days
after the effective date of this AD, whichever occurs later.

(h) No Alternative Actions and Intervals

    After accomplishing the revision required by paragraph (g) of
this AD, no alternative actions (e.g., inspections) or intervals may
be used unless the actions or intervals are approved as an
alternative method of compliance (AMOC) in accordance with the
procedures specified in paragraph (i)(1) of this AD.

(i) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Branch, ANM-116, FAA, has the authority to approve
AMOCs for this AD, if requested using the procedures found in 14 CFR
39.19. In accordance with 14 CFR 39.19, send your request to your
principal inspector or local Flight Standards District Office, as
appropriate. If sending information directly to the International
Branch, send it to ATTN: Dan Rodina, Aerospace Engineer,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
1601 Lind Avenue SW., Renton, WA 98057-3356; telephone (425) 227-
2125; fax<PHONE_NUMBER>. Information may be emailed to<EMAIL_ADDRESS>Before using any approved AMOC, notify your
appropriate principal inspector, or lacking a principal inspector,
the manager of the local flight standards district office/
certificate holding district office. The AMOC approval letter must
specifically reference this AD.
    (2) Airworthy Product: For any requirement in this AD to obtain
corrective actions from a manufacturer, use these actions if they
are FAA-approved. Corrective actions are considered FAA-approved if
they were approved by the State of Design Authority (or its
delegated agent, or the DAH with a State of Design Authority's
design organization approval, as applicable). You are required to
ensure the product is airworthy before it is returned to service.

(j) Related Information

    (1) Refer to Mandatory Continuing Airworthiness Information
(MCAI) issued European Aviation Safety Agency Airworthiness
Directive 2013-0210, dated September 11, 2013, for related
information. This MCAI may be found in the AD docket on the Internet
at http://www.regulations.gov by searching for and locating Docket
No. FAA-2014-0236.
    (2) For service information identified in this AD, contact
Airbus SAS, Airworthiness Office--EAW, 1 Rond Point Maurice
Bellonte, 31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96;
fax +33 5 61 93 44 51; email<EMAIL_ADDRESS>
Internet http://www.airbus.com. You may view this service
information at the FAA, Transport Airplane Directorate, 1601 Lind
Avenue SW., Renton, WA. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>.
BILLING CODE 4910-13-P

[GRAPHIC] [TIFF OMITTED] TP17AP14.008

[GRAPHIC] [TIFF OMITTED] TP17AP14.009

Docket FAA-2014-0236.

    Issued in Renton, Washington, on April 8, 2014.
John P. Piccola,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2014-08727 Filed 4-16-14; 8:45 am]
BILLING CODE 4910-13-C