[Federal Register Volume 79, Number 211 (Friday, October 31, 2014)]
[Notices]
[Pages 64849-64853]
[FR Doc No: 2014-25888]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-73433; File No. SR-NYSEArca-2014-122]

Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change Relating to Use of
Derivative Instruments by the AdvisorShares Global Echo ETF

October 27, 2014.
    Pursuant to Section 19(b)(1) \1\ of the Securities Exchange Act of
1934 (the ``Act'') \2\ and Rule 19b-4 thereunder,\3\ notice is hereby
given that, on October 23, 2014, NYSE Arca, Inc. (the ``Exchange'' or
``NYSE Arca'') filed with the Securities and Exchange Commission (the
``Commission'') the proposed rule change as described in Items I and II
below, which Items have been prepared by the self-regulatory
organization. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 15 U.S.C. 78a.
    \3\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to reflect a change to the means of achieving
the investment objective applicable to the AdvisorShares Global Echo
ETF (``The Fund'') relating to its use of derivative instruments. The
text of the proposed rule change is available on the Exchange's Web
site at www.nyse.com, at the principal office of the Exchange, and at
the Commission's Public Reference Room.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the self-regulatory organization
included statements concerning the purpose of, and basis for, the
proposed rule change and discussed any comments it received on the
proposed rule change. The text of those statements may be examined at
the places specified in Item IV below. The Exchange has prepared
summaries, set forth in sections A, B, and C below, of the most
significant parts of such statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and the
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The Commission has approved listing and trading on the Exchange of
shares (``Shares'') of the Fund under NYSE Arca Equities Rule 8.600,
which governs the listing and trading of Managed Fund Shares on the
Exchange.\4\ The Shares are offered by AdvisorShares Trust (``Trust''),
a statutory trust organized under the laws of the State of Delaware and
registered with the Commission as an open-end management investment
company.\5\
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    \4\ The Commission originally approved the listing and trading
of the Shares on the Exchange on May 16, 2012. See Securities
Exchange Act Release No. 67003 (May 16, 2012), 77 FR 30345 (May 22,
2012) (SR-NYSEArca-2012-24) (``Prior Order''). See also Securities
Exchange Act Release No. 66696 (March 30, 2012), 77 FR 20660 (April
5, 2012) (SR-NYSEArca-2012-24) (``Prior Notice'').
    \5\ The Trust is registered under the Investment Company Act of
1940 (15 U.S.C. 80a-1) (``1940 Act''). On July 15, 2011, the Trust
filed with the Commission Post-Effective Amendment No. 32 to Form N-
1A under the Securities Act of 1933 (15 U.S.C. 77a), and under the
1940 Act relating to the Fund (File Nos. 333-157876 and 811-22110)
(``Registration Statement''). The description of the operation of
the Trust and the Fund herein is based, in part, on the Registration
Statement. In addition, the Commission has issued an order granting
certain exemptive relief to the Trust under the 1940 Act. See
Investment Company Act Release No. 29291 (May 28, 2010) (File No.
812-13677) (``Exemptive Order'').
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    The investment adviser to the Fund is AdvisorShares Investments,
LLC (``Adviser''). The Fund's sub-advisers (``Sub-Advisers'' and each a
``Sub-Adviser''), which provide day-to-day portfolio management of the
Fund, are First Affirmative Financial Network LLC; Reynders, McVeigh
Capital Management, LLC; Baldwin Brothers Inc.; and Community Capital
Management Inc.
    In this proposed rule change, the Exchange proposes to change the
description of the Fund's use of

derivative instruments, as described below.\6\
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    \6\ The Adviser represents that the Adviser and the Sub-Advisers
have managed and will continue to manage the Fund in the manner
described in the Prior Notice, and will not implement the changes
described herein until the instant proposed rule change is
operative.
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    On December 6, 2012, the staff of the Commission's Division of
Investment Management (``Division'') issued a no-action letter (``No-
Action Letter'') relating to the use of derivatives by actively-managed
exchange-traded funds (``ETFs'').\7\ The No-Action Letter noted that,
in March of 2010, the Commission announced in a press release that the
staff was conducting a review to evaluate the use of derivatives by
mutual funds, ETFs, and other investment companies and that, pending
completion of this review, the staff would defer consideration of
exemptive requests under the 1940 Act relating to, among others,
actively-managed ETFs that would make significant investments in
derivatives.
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    \7\ See No-Action Letter dated December 6, 2012 from Elizabeth
G. Osterman, Associate Director, Office of Exemptive Applications,
Division of Investment Management.
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    The No-Action Letter stated that the Division staff will no longer
defer consideration of exemptive requests under the 1940 Act relating
to actively-managed ETFs that make use of derivatives provided that
they include representations to address some of the concerns expressed
in the Commission's March 2010 press release. These representations
are: (i) That the ETF's board periodically will review and approve the
ETF's use of derivatives and how the ETF's investment adviser assesses
and manages risk with respect to the ETF's use of derivatives; and (ii)
that the ETF's disclosure of its use of derivatives in its offering
documents and periodic reports is consistent with relevant Commission
and staff guidance (together, the ``No-Action Letter
Representations''). The No-Action Letter stated that the Division would
not recommend enforcement action to the Commission under sections
2(a)(32), 5(a)(1), 17(a), 22(d), and 22(e) of the 1940 Act, or rule
22c-1 under the 1940 Act if actively-managed ETFs operating in reliance
on specified orders (which include the Trust's Exemptive Order \8\)
invest in options contracts, futures contracts or swap agreements
provided that they comply with the No-Action Letter Representations.\9\
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    \8\ See supra, note 5.
    \9\ The Adviser acknowledges that for the Fund to rely on the
No-Action Letter, the Fund must comply with the No-Action Letter
Representations. In this regard, (i) the Board of Trustees of the
Trust will periodically review and approve the Fund's use of
derivatives and how the Adviser assesses and manages risk with
respect to the Fund's use of derivatives and (ii) the Fund's
disclosure of its use of derivatives in its offering documents and
periodic reports will be consistent with relevant Commission and
staff guidance.
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    The Prior Notice included the following representation: ``Further,
in accordance with the Exemptive Order, the Fund will not invest in
options, futures, or swaps.'' (the ``Derivatives Representation''). In
view of the No-Action Letter, the Exchange is proposing to delete the
Derivatives Representation. The Exchange now proposes that, to pursue
the Fund's investment objective, the Fund be permitted to invest in
options, futures, and forward contracts (``Derivative Instruments''),
as described below.
    Going forward, the Fund may buy and sell futures contracts and
options on futures contracts. The Fund will only enter into futures
contracts and options on futures contracts that are traded on a
national futures exchange that is regulated by the Commodities Futures
Trading Commission (``CFTC'') and that is a member of the Intermarket
Surveillance Group (``ISG'').\10\ With respect to the Fund's
investments in futures contracts and options on futures contracts, the
Fund may buy and sell only index futures contracts and options on
futures contracts with respect to any index on which futures or options
on futures are traded on a U.S. futures exchange. The Fund may use such
index futures contracts and related options on futures contracts for
bona fide hedging; attempting to offset changes in the value of
securities held or expected to be acquired or be disposed of;
attempting to gain exposure to a particular market, index or
instrument; or other risk management purposes.
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    \10\ To the extent the Fund invests in futures, options on
futures or other instruments subject to regulation by the CFTC, it
will do so in reliance on and in compliance with CFTC regulations in
effect from time to time and in accordance with the Fund's policies.
The Trust, on behalf of certain of its series, has filed a notice of
eligibility for exclusion from the definition of the term
``commodity pool operator'' in accordance with CFTC Regulation 4.5.
Therefore, neither the Trust nor the Fund is deemed to be a
``commodity pool'' or ``commodity pool operator'' with respect to
the Fund under the Commodity Exchange Act (``CEA''), and they are
not subject to registration or regulation as such under the CEA. In
addition, as of the date of this filing, the Adviser is not deemed
to be a ``commodity pool operator'' or ``commodity trading adviser''
with respect to the advisory services it provides to the Fund. The
CFTC recently adopted amendments to CFTC Regulation 4.5 and has
proposed additional regulatory requirements that may affect the
extent to which the Fund invests in instruments that are subject to
regulation by the CFTC and impose additional regulatory obligations
on the Fund and the Adviser. The Fund reserves the right to engage
in transactions involving futures and options thereon to the extent
allowed by CFTC regulations in effect from time to time and in
accordance with the Fund's policies.
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    The Fund may invest in exchange-traded put and call options on
securities indices and currencies. The Fund may purchase and write
options only if such options are traded on a U.S. national securities
exchange.
    The Fund may invest in currency forwards.
    Under normal market conditions, no more than 20% of the value of
the Fund's net assets will be invested in Derivative Instruments.\11\
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    \11\ The Fund will limit its direct investments in futures to
the extent necessary for the Adviser to claim the exclusion from
regulation as a ``commodity pool operator'' with respect to the Fund
under Rule 4.5 promulgated by the CFTC, as such rule may be amended
from time to time. Under Rule 4.5 as currently in effect, the Fund
will limit its trading activity in futures and options on futures
(excluding activity for ``bona fide hedging purposes,'' as defined
by the CFTC) such that it will meet one of the following tests: (i)
Aggregate initial margin and premiums required to establish its
futures and options on futures will not exceed 5% of the liquidation
value of the Fund's portfolio, after taking into account unrealized
profits and losses on such positions; or (ii) aggregate net notional
value of its futures and options on futures will not exceed 100% of
the liquidation value of the Fund's portfolio, after taking into
account unrealized profits and losses on such positions.
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    The Prior Notice stated that the Fund's investments would be
consistent with the Fund's investment objective and would not be used
to enhance leverage. In view of the Exchange's proposal to permit the
Fund to use Derivative Instruments, the Fund's investments in
Derivative Instruments could potentially be used to enhance leverage.
However, the Fund's investments in Derivative Instruments will be
consistent with the Fund's investment objective and will not be used to
seek to achieve a multiple or inverse multiple of an index.
    Investments in Derivative Instruments will be made in accordance
with the 1940 Act and consistent with the Fund's investment objective
and policies. The Fund will comply with the regulatory requirements of
the Commission to maintain assets as ``cover,'' maintain segregated
accounts, and/or make margin payments when it takes positions in
Derivative Instruments involving obligations to third parties (i.e.,
instruments other than purchase options). If the applicable guidelines
prescribed under the 1940 Act so require, the Fund will earmark or set
aside cash, U.S. government securities, high grade liquid debt
securities and/or other liquid assets permitted by the Commission in a
segregated custodial account in the amount prescribed.\12\
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    \12\ With respect to guidance under the 1940 Act, see 15 U.S.C.
80a-18; Investment Company Act Release No. 10666 (April 18, 1979),
44 FR 25128 (April 27, 1979); Dreyfus Strategic Investing,
Commission No-Action Letter (June 22, 1987); Merrill Lynch Asset
Management, L.P., Commission No-Action Letter (July 2, 1996).

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    The Fund will include appropriate risk disclosure in its offering
documents, including leveraging risk. Leveraging risk is the risk that
certain transactions of the Fund, including the Fund's use of
Derivative Instruments, may give rise to leverage, causing the Fund to
be more volatile than if it had not been leveraged.\13\
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    \13\ To mitigate leveraging risk, the Fund will segregate or
``earmark'' liquid assets or otherwise cover the transactions that
may give rise to such risk.
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    Based on the above, the Exchange seeks this modification regarding
the Fund's use of Derivative Instruments. The Adviser represents that
there is no change to the Fund's investment objective. The Adviser and
the Sub-Advisers believe that the ability to invest in Derivative
Instruments will provide the Adviser and Sub-Advisers with additional
flexibility to meet the Fund's investment objective.
    The Fund will continue to comply with all initial and continued
listing requirements under NYSE Arca Equities Rule 8.600.
    Except for the changes noted herein, all other facts presented and
representations made in the Rule 19b-4 filing underlying the Prior
Order remain unchanged.
    The changes described herein will be effective upon (i) the
effectiveness of an amendment to the Trust's Registration Statement
disclosing the Fund's intended use of Derivative Instruments and (ii)
when this proposed rule change has become operative. The Adviser
represents that the Adviser and Sub-Advisers have managed and will
continue to manage the Fund in the manner described in the Prior
Notice, and will not implement the changes described herein until this
proposed rule change is operative.
Impact on Arbitrage Mechanism
    The Adviser believes there will be minimal, if any, impact to the
arbitrage mechanism as a result of the use of derivatives. Market
makers and participants should be able to value derivatives as long as
the positions are disclosed with relevant information. The Adviser
believes that the price at which Shares trade will continue to be
disciplined by arbitrage opportunities created by the ability to
purchase or redeem Creation Units (as defined in the Prior Notice) at
their net asset value (``NAV''), which should ensure that Shares will
not trade at a material discount or premium in relation to their NAV.
    The Adviser does not believe there will be any significant impacts
to the settlement or operational aspects of the Fund's arbitrage
mechanism due to the use of derivatives. Certain derivatives may not be
eligible for in-kind transfer, and such derivatives will be substituted
with a ``cash in lieu'' amount when the Fund processes purchases or
redemptions of Creation Units (as defined in the Prior Notice) in-kind.
Valuation for Purposes of Calculating Net Asset Value
    As stated in the Prior Notice, the NAV per Share of the Fund is
computed by dividing the value of the net assets of the Fund (i.e., the
value of its total assets less total liabilities) by the total number
of Shares of the Fund outstanding, rounded to the nearest cent.
Expenses and fees, including without limitation, the management,
administration, and distribution fees, are accrued daily and taken into
account for purposes of determining NAV. The NAV per Share for the Fund
is calculated by the Administrator (The Bank of New York Mellon
Corporation) and determined as of the close of the regular trading
session on the New York Stock Exchange (``NYSE'') (ordinarily 4:00
p.m., E.T.) on each day that the NYSE is open.
    U.S. exchange-traded options will be valued at the closing price
determined by the applicable exchange. The Fund will generally value
exchange-traded futures at the settlement price determined by the
applicable exchange. Currency forward contracts will normally be valued
on the basis of quotes obtained from a third party broker-dealer who
makes markets in such securities or on the basis of quotes obtained
from an independent third-party pricing service.
Availability of Information
    As described in the Prior Notice, on each business day, before
commencement of trading in Shares in the Core Trading Session on the
Exchange, the Fund discloses on its Web site the Disclosed Portfolio as
defined in NYSE Arca Equities Rule 8.600(c)(2) that will form the basis
for the Fund's calculation of NAV at the end of the business day. See
``Disclosed Portfolio'' below.
    Pricing information for Derivative Instruments will be available
from major broker-dealer firms, subscription services, and/or pricing
services and, in addition, for exchange-traded Derivative Instruments,
from the exchanges on which they are traded.
    Intra-day and closing price information regarding exchange traded
options (including options on futures) and futures will be available
from the exchange on which such instruments are traded. Quotation and
last sale information for exchange-traded options cleared via the
Options Clearing Corporation is available from the Options Price
Reporting Authority.
Disclosed Portfolio
    The Fund's disclosure of derivative positions in the Disclosed
Portfolio will include information that market participants can use to
value these positions intraday. On a daily basis, the Fund will
disclose on the Fund's Web site the following information regarding
each portfolio holding, as applicable to the type of holding: Ticker
symbol, CUSIP number or other identifier, if any; a description of the
holding (including the type of holding); the identity of the security
or other asset or instrument underlying the holding, if any; for
options, the option strike price; quantity held (as measured by, for
example, par value, notional value or number of shares, contracts or
units); maturity date, if any; coupon rate, if any; effective date, if
any; market value of the holding; and the percentage weighting of the
holding in the Fund's portfolio.
Surveillance
    The Exchange represents that trading in the Shares will be subject
to the existing trading surveillances, administered by the Financial
Industry Regulatory Authority (``FINRA'') on behalf of the Exchange,
which are designed to detect violations of Exchange rules and
applicable federal securities laws.\14\ The Exchange represents that
these procedures are adequate to properly monitor Exchange trading of
the Shares in all trading sessions and to deter and detect violations
of Exchange rules and federal securities laws applicable to trading on
the Exchange.
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    \14\ FINRA surveils trading on the Exchange pursuant to a
regulatory services agreement. The Exchange is responsible for
FINRA's performance under this regulatory services agreement.
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    The surveillances referred to above generally focus on detecting
securities trading outside their normal patterns, which could be
indicative of manipulative or other violative activity. When such
situations are detected, surveillance analysis follows and
investigations are opened, where appropriate, to review the behavior of
all relevant parties for all relevant trading violations.

    FINRA, on behalf of the Exchange, will communicate as needed
regarding trading in the Shares, exchange-traded options, exchange-
traded futures and exchange-traded options on futures with other
markets and other entities that are members of the ISG, and FINRA, on
behalf of the Exchange, may obtain trading information regarding
trading in the Shares, exchange-traded options, exchange-traded futures
and exchange-traded options on futures from such markets and other
entities. In addition, the Exchange may obtain information regarding
trading in the Shares, exchange-traded options, exchange-traded futures
and exchange-traded options on futures, from markets and other entities
that are members of ISG or with which the Exchange has in place a
comprehensive surveillance sharing agreement.\15\
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    \15\ For a list of the current members of ISG, see
www.isgportal.org. The Exchange notes that not all components of the
Disclosed Portfolio for the Fund may trade on markets that are
members of ISG or with which the Exchange has in place a
comprehensive surveillance sharing agreement.
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    In addition, the Exchange also has a general policy prohibiting the
distribution of material, non-public information by its employees.
2. Statutory Basis
    The basis under the Act for this proposed rule change is the
requirement under Section 6(b)(5) \16\ that an exchange have rules that
are designed to prevent fraudulent and manipulative acts and practices,
to promote just and equitable principles of trade, to remove
impediments to, and perfect the mechanism of a free and open market
and, in general, to protect investors and the public interest.
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    \16\ 15 U.S.C. 78f(b)(5).
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    The Exchange believes that the proposed rule change is designed to
prevent fraudulent and manipulative acts and practices in that, under
normal market conditions, no more than 20% of the value of the Fund's
net assets will be invested in Derivative Instruments. The Fund's
investments in Derivative Instruments will be consistent with the
Fund's investment objective and will not be used to seek to achieve a
multiple or inverse multiple of an index. Investments in Derivative
Instruments will be made in accordance with the 1940 Act and consistent
with the Fund's investment objective and policies. The Fund will comply
with the regulatory requirements of the Commission to maintain assets
as ``cover,'' maintain segregated accounts, and/or make margin payments
when it takes positions in Derivative Instruments involving obligations
to third parties (i.e., instruments other than purchase options). If
the applicable guidelines prescribed under the 1940 Act so require, the
Fund will earmark or set aside cash, U.S. government securities, high
grade liquid debt securities and/or other liquid assets permitted by
the Commission in a segregated custodial account in the amount
prescribed. Moreover, the Fund will include appropriate risk disclosure
in its offering documents, including leveraging risk.
    The proposed rule change is designed to promote just and equitable
principles of trade and to protect investors and the public interest in
that the Fund's disclosure of derivative positions in the Disclosed
Portfolio will include information that market participants can use to
value these positions intraday. On a daily basis, the Fund will
disclose on the Fund's Web site specific information regarding each
portfolio holding, as applicable to the type of holding. The Fund may
use futures contracts and related options for bona fide hedging;
attempting to offset changes in the value of securities held or
expected to be acquired or be disposed of; attempting to gain exposure
to a particular market, index or instrument; or other risk management
purposes. In addition, such proposed change will provide the Adviser
and Sub-Advisers with additional flexibility in meeting the Fund's
investment objective. The Adviser does not believe there will be any
significant impacts to the settlement or operational aspects of the
Fund's arbitrage mechanism due to the use of derivatives. In addition,
the Commission has previously approved the use of derivatives similar
to those proposed herein by issues of Managed Fund Shares traded on the
Exchange.\17\ Consistent with the Prior Notice, NAV will continue to be
calculated daily and the NAV and Disclosed Portfolio (as defined in
NYSE Arca Equities Rule 8.600(c)(2)) will be made available to all
market participants at the same time.
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    \17\ See, e.g., Securities Exchange Act Release Nos. 73081
(September 11, 2014), 79 FR 55859 (September 17, 2014) (SR-NYSEArca-
2014-20) (order approving listing and trading on the Exchange of
shares of the Reality Shares DIVS ETF under NYSE Arca Equities Rule
8.600); 72882 (August 20, 2014), 79 FR 50964 (August 26, 2014) (SR-
NYSEArca-2014-58) (order approving listing and trading on the
Exchange of shares of the PIMCO Short-Term Exchange-Traded Fund and
the PIMCO Municipal Bond Exchange-Traded Fund under NYSE Arca
Equities Rule 8.600).
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    The proposed rule change is designed to perfect the mechanism of a
free and open market and, in general, to protect investors and the
public interest in that it will facilitate the listing and trading of
an actively-managed exchange-traded product that will enhance
competition among market participants, to the benefit of investors and
the marketplace. As noted, the additional flexibility to be afforded to
the Adviser and Sub-Advisers by permitting the Fund to invest in
Derivative Instruments under the proposed rule change is intended to
enhance the Adviser's and Sub-Advisers' ability to meet the Fund's
investment objective. FINRA, on behalf of the Exchange, will
communicate as needed regarding trading in the Shares, exchange-traded
options, exchange-traded futures and exchange-traded options on futures
with other markets and other entities that are members of the ISG, and
FINRA, on behalf of the Exchange, may obtain trading information
regarding trading in the Shares, exchange-traded options, exchange-
traded futures and exchange-traded options on futures from such markets
and other entities. In addition, the Exchange may obtain information
regarding trading in the Shares, exchange-traded options, exchange-
traded futures and exchange-traded options on futures from markets and
other entities that are members of ISG or with which the Exchange has
in place a comprehensive surveillance sharing agreement. In addition,
as indicated in the Prior Notice, investors will have ready access to
information regarding the Fund's holdings, the Portfolio Indicative
Value (as defined in NYSE Arca Equities Rule 8.600(d)(2)(A)), the
Disclosed Portfolio, and quotation and last sale information for the
Shares. Consistent with the No-Action Letter, (i) the Board of Trustees
of the Trust will periodically review and approve the Fund's use of
derivatives and how the Adviser assesses and manages risk with respect
to the Fund's use of derivatives and (ii) the Fund's disclosure of its
use of derivatives in its offering documents and periodic reports will
be consistent with relevant Commission and staff guidance.

B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act. The Exchange believes the
proposed rule change will permit the Adviser and Sub-Advisers
additional flexibility in achieving the Fund's investment objective,
thereby offering investors additional investment options.

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

    No written comments were solicited or received with respect to the
proposed rule change.

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

    Because the foregoing proposed rule change does not: (i)
Significantly affect the protection of investors or the public
interest; (ii) impose any significant burden on competition; and (iii)
become operative for 30 days from the date on which it was filed, or
such shorter time as the Commission may designate, if consistent with
the protection of investors and the public interest, the proposed rule
change has become effective pursuant to Section 19(b)(3)(A) of the Act
\18\ and Rule 19b-4(f)(6) thereunder.\19\
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    \18\ 15 U.S.C. 78s(b)(3)(A).
    \19\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)
requires a self-regulatory organization to give the Commission
written notice of its intent to file the proposed rule change at
least five business days prior to the date of filing of the proposed
rule change, or such shorter time as designated by the Commission.
The Exchange has satisfied this requirement.
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    At any time within 60 days of the filing of the proposed rule
change, the Commission may summarily abrogate such rule change if it
appears to the Commission that such action is necessary or appropriate
in the public interest, for the protection of investors, or otherwise
in furtherance of the purposes of the Act.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-NYSEArca-2014-122 on the subject line.

Paper Comments

     Send paper comments in triplicate to Secretary, Securities
and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.

All submissions should refer to File Number SR-NYSEArca-2014-122. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549, on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of such filing will also be available
for inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-NYSEArca-2014-122 and should
be submitted on or before November 21, 2014.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\20\
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    \20\ 17 CFR 200.30-3(a)(12).
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Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2014-25888 Filed 10-30-14; 8:45 am]
BILLING CODE 8011-01-P


Imports, Motor vehicles, Motor vehicle safety.

    In consideration of the foregoing, NHTSA amends 49 CFR part 571 as
follows:

PART 571--FEDERAL MOTOR VEHICLE SAFETY STANDARDS

0
1. The authority citation for part 571 continues to read as follows:

    Authority: 49 U.S.C. 322, 30111, 30115, 30117, and 30166;
delegation of authority at 49 CFR 1.95.

Subpart B--Federal Motor Vehicle Safety Standards

0
2. Section 571.227 is added to read as follows:

Sec.  571.227  Standard No. 227; Bus rollover structural integrity.

    S1. Scope. This standard establishes performance requirements for
bus rollover structural integrity.
    S2. Purpose. The purpose of this standard is to reduce death and
injuries resulting from the structural collapse of the bus body
structure in rollover crashes and from partial and complete ejections
through emergency exits opening in such crashes.
    S3. Application.

    (a) Subject to S3(b), this standard applies to:
    (1) Over-the-road buses; and
    (2) Buses that are not over-the-road buses, and that have a gross
vehicle weight rating (GVWR) greater than 11,793 kilograms (26,000
pounds).
    (b) This standard does not apply to:
    (1) School buses, school bus derivative buses, transit buses, and
prison buses; and
    (2) Buses with 7 or fewer designated seating positions rearward of
the driver's seating position that are forward-facing or can convert to
forward-facing without the use of tools.
    S4. Definitions.
    Occupant compartment means a space within the vehicle interior
intended for driver and passenger use, excluding any space occupied by
fixed appliances such as bars, kitchenettes, or toilets.
    Over-the-road bus means a bus characterized by an elevated
passenger deck located over a baggage compartment.
    Prison bus means a bus manufactured for the purpose of transporting
persons subject to involuntary restraint or confinement and has design
features consistent with that purpose.
    School bus is defined in Sec.  571.3.
    School bus derivative bus means a bus that meets Federal motor
vehicle safety standards for school buses regarding emergency exits
(Sec.  571.217), rollover protection (Sec.  571.220), bus body joint
strength (Sec.  571.221), and fuel system integrity (Sec.  571.301).
    Stop-request system means a vehicle-integrated system for passenger
to use to signal to a vehicle operator that they are requesting a stop.
    Survival space means all points within a three-dimensional space in
the occupant compartment as defined within the following volume:
    (1) The front boundary of the survival space is a transverse
vertical plane forward of the most forward seat (whether passenger, or
driver seat) when the seat back is in the manufacturer's nominal design
riding position. This transverse vertical plane is:
    (i) For a forward-facing seat, 600 millimeters (mm) in front of the
forward most point on the longitudinal centerline of the front surface
of the seat back when the seat is in its forward most position;
    (ii) For a rearward-facing seat, through the most forward point
(relative to the vehicle) on the longitudinal centerline of the seat
back when the seat is in its forward most position with respect to the
vehicle;
    (iii) For a side-facing seat, through the most forward point
(relative to the vehicle) on the seat, including the seat back, seat
arm rest, and seat cushion.
    (2) The rear boundary of the survival space is the inside surface
of the rear wall of the occupant compartment of the vehicle.
    (3) The outer boundary of the survival space at any transverse
cross section between, or at the front and rear boundaries, is defined
on each side of the vehicle by the occupant compartment floor and the
following three line segments (see Figure 1 of this section, provided
for illustration purposes only):
    (i) Segment 1 extends vertically from the floor to an end point
that is 500 mm above the floor and 150 mm inboard of the side wall.
    (ii) Segment 2 starts at the end point of Segment 1. The end point
of Segment 2 is 750 mm vertically above and 250 mm horizontally inboard
of the end point of Segment 1.
    (iii) Segment 3 is a horizontal line that starts at the end point
of Segment 2 and ends at the vertical longitudinal center plane of the
vehicle.
    Transit bus means a bus that is equipped with a stop-request system
sold for public transportation provided by, or on behalf of, a State or
local government and that is not an over-the-road bus.
    S5. Requirements. When tested under the conditions in S6 and the
test procedures specified in S7, each bus shall meet the requirements
in S5.1 and S5.2.
    S5.1 Survival space intrusion. No part of the vehicle that is
outside the survival space shall intrude into the survival space during
the movement of the tilting platform or resulting from impact of the
vehicle on the impact surface, except as provided below in this
paragraph.
    (a) Items separated from the vehicle and with a mass less than 15.0
grams that enter the survival space will not be considered for this
evaluation of survival space intrusion.
    (b) Portions of a bus over which there is not a permanent roof,
such as the upper level of an open-top double-decker bus, will not be
considered for this evaluation.
    S5.2 Opening of Emergency exits. Emergency exits shall not open
during the movement of the tilting platform or resulting from impact of
the vehicle on the impact surface.
    S6. Test conditions.
    S6.1 Tilting platform.
    S6.1.1 The tilting platform has a top surface that rests
horizontally at its initial position and is of sufficient size to fully
contact the bottom of the vehicle's tires, as shown in Figure 2 of this
section (figure provided for illustration purposes only).
    S6.1.2 The top surface of the tilting platform, at its initial
position, is 800  20 millimeters (mm) above the impact
surface specified in S6.1.6, as shown in Figures 1 and 2 of this
section (figures provided for illustration purposes only).
    S6.1.3 The axis of rotation of the tilting platform is a maximum of
a 100 mm horizontal distance from the edge of the impact surface
closest to the platform and a maximum of 100 mm below the horizontal
plane at the top surface of the tilting platform as shown in Figure 3
of this section (figure provided for illustration purposes only).
    S6.1.4 The tilting platform is equipped with rigid wheel supports
on the top surface as illustrated in Figure 3 of this section (figure
provided for illustration purposes only). At each vehicle axle, the
wheel closest to the platform's axis of rotation is supported. The
rigid wheel supports are positioned to make contact with the outboard
tire sidewall of the supported wheels with the vehicle positioned as
specified in S6.3.1 to prevent sliding of the vehicle during the test.
Each rigid wheel support has the following dimensions:
    (a) The height above the top surface of the tilting platform is no
greater than two-thirds of the vertical height of the adjacent tire's
sidewall.
    (b) The width is a minimum of 19 mm.
    (c) The length is a minimum of 500 mm.
    (d) The top inboard edge has a radius of 10 mm.
    S6.1.5 While raising the platform, the tilting platform roll angle,
measured at the outside of each wheel farthest from the pivot point,
does not differ by more than one degree.
    S6.1.6 The impact surface is horizontal, uniform, dry, and smooth
concrete. The impact surface covers an area that is large enough to
ensure that the vehicle does not strike beyond the impact surface
edges.
    S6.2 Vehicle preparation.
    S6.2.1 The vehicle's tires are inflated to the manufacturer's
recommended tire pressure.
    S6.2.2 Test equipment may be attached securely to the bus structure
such that the equipment does not break away from the bus structure from
the time the tilting platform begins movement to after the vehicle
comes to rest on the impact surface.
    S6.2.3 Fixed seats may be removed or adjustable seats repositioned
for the installation of test equipment in the survival space. Ballast
of any weight up to the weight of the removed seat and 68 kg per
designated seating position

may be secured to the bus floor. The ballasts are not placed farther
forward than the forward most point of the vehicle seat immediately in
front of the removed seat, and the ballasts are not placed farther
rearward than the rear most point of the vehicle seat immediately
behind the removed seat.
    S6.2.4 The fuel tank is filled to any level from 90 to 95 percent
of capacity. All other vehicle fluids are filled to any level from 90
to 95 percent of capacity. Fluids may be substituted if the weight of
the original fluid is maintained.
    S6.2.5 Ballasting. The vehicle is loaded to any weight up to and
including the GVWR. Up to 68 kilograms (150 pounds) of ballast is
installed at all designated seating positions that are equipped with
occupant restraints. The ballast is placed on the top of each seat
cushion and attached securely to the seat frame such that it does not
break away from the seat from the time the tilting platform begins
movement to after the vehicle comes to rest on the impact surface.
    S7 Rollover structural integrity test procedure. Each vehicle shall
meet the requirements of S5 when prepared as specified in S6.2 and
tested in accordance with the procedures set forth in paragraphs (a)
through (f) of this S7.
    (a) Position the vehicle on the tilting platform as illustrated in
the examples of Figures 2 and 3 of this section with its longitudinal
centerline parallel to the tilt platform's axis of rotation, the right
or left side facing the impact surface at NHTSA's option, and with the
outboard tire sidewall at the widest axle within 100 mm of the axis of
rotation. (Figures provided for illustration purposes only.)
    (b) Apply the vehicle parking brakes.
    (c) Attach a rigid wheel support to the tilting platform at each
axle of the vehicle so that it contacts the outboard tire sidewall of
the wheel closest to the impact surface.
    (d) Block the suspension system of the vehicle to be within 25 mm of the normal riding attitude as loaded in S6.2.5.
    (e) Vehicle windows, doors, and emergency exits are fully closed
and latched but not locked.
    (f) Tilt the vehicle at a rate not to exceed 5 degrees/second until
it starts to rollover on its own.
BILLING CODE 4910-59-P

[GRAPHIC] [TIFF OMITTED] TR29DE21.003

[GRAPHIC] [TIFF OMITTED] TR29DE21.004

[GRAPHIC] [TIFF OMITTED] TR29DE21.005

    Issued under authority delegated in 49 CFR 1.95.

Steven Cliff,
Deputy Administrator.
[FR Doc. 2021-27538 Filed 12-28-21; 8:45 am]
 BILLING CODE 4910-59-C


Attachment B: Job Training Reporting Form   Brownfields The public reporting and recordkeeping burden for this collection of information is estimated to average 5 hours per response. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.

To comment on the Agency's need for this information, the accuracy of the provided burden estimates, and any suggested methods for minimizing respondent burden, including the use of automated collection techniques, EPA has established a public docket for this ICR under Docket ID No. SFUND 2003 0004, which is available for public viewing at the OSWER Docket in the EPA Docket Center ( EPA/ DC), EPA West, Room B102, 1301 Constitution Ave., NW, Washington, DC. The EPA Docket Center Public Reading Room is open from 8: 30 a. m. to 4: 30 p. m., Monday through Friday, excluding legal holidays. The telephone number for the Reading Room is ( 202) 566 1744, and the telephone number for the OSWER Docket is ( 202) 566 2426. An electronic version of the public docket is available through EPA Dockets ( EDOCKET) at http:// www. epa. gov/ edocket. Use EDOCKET to submit or view public comments, access the index listing of the contents of the public docket, and to access those documents in the public docket that are available electronically. Once in the system, select " search," then key in the docket ID number identified above. Also, you can send comments to the Office of Information and Regulatory Affairs, Office of Management and Budget, 725 17th Street, NW, Washington, DC 20503, Attention: Desk Office for EPA. Please include the EPA Docket ID No. SFUND 2003 0004 and OMB control number ( 2050 NEW) in any correspondence. EPA Form 9310 2 ( 8 2003) United States ENVIRONMENTAL PROTECTION AGENCY Washington, DC 20460 Form Approved. OMB No. 2050 XXXX Expires XX XX XXXX JOB TRAINING REPORTING FORM Brownfields PART I   GRANT RECIPIENT INFORMATION 1. Grant Recipient Name 2. Grant Number Public reporting burden for this collection of information is estimated to average 5 hours per response, including the time for reviewing instructions, searching data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. Send comments regarding this burden estimate, or any other aspect of this collection of information, including suggestions for reducing this burden, to the Environmental Protection Agency, Office of Environmental Information, Code 2822T, Washington, DC 20460 and to the Paperwork Reduction Project, Office of Management and Budget, Washington, DC 20503. DO NOT RETURN your form to either of these addresses. Send your completed form to the address provided by the issuing office. PART II   PERFORMANCE MEASURES INFORMATION Table A   Mandatory Performance Measures Measure ( a) This Quarter ( b) Cumulative 3. Number of Participants Completing Training 4. Number of Participants Obtaining Employment 5. Average Hourly Wage of Participants Obtaining Employment 6. Funds Leveraged ( total)

6 1. Funding Source Name 6 2. Activity Funded 6 1. Funding Source Name 6 2. Activity Funded 6 1. Funding Source Name 6 2. Activity Funded 7. Supplemental Performance Measures Information ( optional)

PART III   APPROVALS 8. Grant Recipient Project Manager Name Signature Date 9. US EPA Regional Representative Name Signature Date EPA Form 9310 2 ( 8 2003) INSTRUCTIONS FOR COMPLETING JOB TRAINING REPORTING FORM  BROWNFIELDS GENERAL INSTRUCTIONS Overview: As specified in your grant terms and conditions, all job training grant recipients must report to EPA on a regular basis. This OMB and EPA approved reporting form ( OMB No. 2050  ####, EPA Form 9310 2), supplements your Quarterly Reports with information about specific activities and accomplishments that EPA deems necessary to adequately monitor and evaluate the performance of job training grants. Please contact your EPA Regional representative if you have any questions when completing this form. Please note that, in most instances, all reported information is accessible by the public under the Freedom of Information Act ( FOIA) and may be distributed by EPA to the public unless one of the FOIA exclusions is applicable.

Compared to the Quarterly Reports, the Brownfields Job Training Reporting Form ( JT Reporting form) contains quantitative information relating to four specific measures of grant recipient performance. Reporting on these specific activities and accomplishments must be provided in the attached JT Reporting form rather than in the Quarterly Reports. Additional voluntary and/ or narrative information may be provided in Part II of this form or in the Quarterly Report.

When to Submit: Original JT Reporting Forms. Grant recipients must develop the first JT Reporting form when the first specified accomplishment has occurred ( e. g., when the first class of trainees " graduates" from the training program provided under the grant, or when leveraged funding is committed to supplement the grant activities). The form should be attached and delivered with the next required Quarterly Report.

Updated JT Reporting Forms. JT Reporting forms should be updated and delivered as additional accomplishments occur, and should be attached to the next required Quarterly Report. In addition, an updated form should be provided when the grant is being closed out.

To Whom to Submit: Grant recipients should submit the JT Reporting forms to their EPA Regional Representative identified in the terms and conditions of the cooperative agreement and the EPA Headquarters Data Manager.

How to Submit: EPA is undertaking a two phased process to facilitate electronic reporting and information dissemination system to facilitate future grant recipient reporting. In the first phase, EPA will prepare electronic versions of this and other required reporting forms for the grant recipients to complete and submit via e mail. In the second phase, EPA will develop a web based database that will allow entry of the information directly by the grant recipient or the Region. As needed, EPA will continue to provide contractor data entry and quality assurance support. Electronic reporting is optional, hard copy reports always will be acceptable. EPA Form 9310 2 ( 8 2003) DETAILED INSTRUCTIONS FOR COMPLETING EACH ITEM ON FORM PART I  GRANT RECIPIENT INFORMATION 1. Grant Recipient Name. Enter the grant name. Use the official name of the grant recipient as provided in the cooperative agreement, unless otherwise directed by the EPA Regional Representative.

2. Grant Number. Enter the grant number. Use the number of the grant as provided in the cooperative agreement.

PART II  PERFORMANCE MEASURES INFORMATION This section contains two parts   one mandatory, for certain limited performance measures information ( Table A); the other optional, for narrative information to supplement the quantitative information provided ( section 7).

Table A  Mandatory Performance Measures. In Table A, provide all quantitative information relating to each of the four ( 4) mandatory performance measures. For each measure, enter amounts in column ( a)   This Quarter   to reflect the incremental accomplishments attained during the current reporting quarter and column ( b)   Cumulative   to reflect the total accomplishments attained to date during the term of the grant. Note: Quantitative information relating to these performance measures should only be provided in the table ( i. e., not in narrative reporting contained in the Quarterly Report).

3. Number of Participants Completing Training. Enter the number of participants taking the grant funded training who have completed the training program.

4. Number of Participants Obtaining Employment. Enter the number of graduates from the grant funded training program who have obtained employment of any kind. Self employed graduates should be included in this count. The cumulative total number inserted in column ( b) should only increase during the term of the grant; the grant recipients' quantitative reporting of the cumulative total should not reflect any decreases for graduates who had obtained employment, but later report losing their jobs. If desired, provide a brief narrative description in section 7 for any reported job losses.

5. Average Hourly Wage. Enter the average hourly wage of job training graduates in their initial posttraining employment. Provide the hourly wage for the first job that each employed graduate secures after completing the job training program. Anecdotal informa tion about subsequent jobs and wages may also be narratively provided by the grant recipient.

6. Funds Leveraged. Enter the total amount of funding leveraged as a result of grant activities. Capture the total number of non grant dollars linked and leve raged to support additional, related activities of the grant recipient. To be reportable, there must be a demonstrable link or connection between the EPA funded activity and the leveraged funding. Funding can occur through direct financial assistance and/ or through inkind services or supplies. Usually, leveraged funding that was committed prior to the award of the EPA grant should not be reported as leveraged since the activity predates the award. In addition, leveraged funding should not be reported in this section until the funding has been committed. These leveraged funds may be used to support activities that cannot be funded by the EPA grant ( e. g., transportation or child care for job training students).

In addition to the total leveraged funds, also describe the source and amount of funding leveraged, and the EPA Form 9310 2 ( 8 2003) types of activities it funded. For each funding source ( 6 1), also list the type of activity funded ( 6 2) and the amount of funding leveraged per source in columns ( a) and ( b). As necessary, add additional lines for 6 1 and 6 2.

6 1. Funding Source Name( s). For each funding source, enter the name of the organization providing the funds and/ or in kind services. Examples of sources of leveraged funding include other EPA programs, private organizations, state environmental, labor, or economic agencies, tribal governments, local governments ( including community development corporations), and other federal agencies.

6 2. Activity Funded. For each funding source listed under 6 1, provide the type of activity that was supported. Examples of leveraged activities include additional curricula development/ training ( e. g., environmental and non environmental), supplies/ equipment, transportation for students, and child care for students.

7. Supplement Performance Measures Information ( Optional). Provide a brief narrative description to supplement the required performance measures reporting, including, for example: demographic information ( e. g., gender, age, ethnicity, education); description of the training curricula; information on the types of jobs obtained by the participants entering/ completing the training; availability of photographs/ video footage of the training/ graduation/ post training employment; and/ or specific milestones tracked by the grant recipient for its own management.

PART III  APPROVALS 8. Grant Recipient Project Manager. Type or print the name of the grant recipient project manager. The project manager must also sign and date the completed JT Reporting form before submission.

9. U. S. EPA Regional Representative. Type or print the name of the EPA Regional Representative. The EPA representative should also sign and date the reviewed JT Reporting form.


[Federal Register Volume 77, Number 234 (Wednesday, December 5, 2012)]
[Notices]
[Pages 72359-72361]
[FR Doc No: 2012-29499]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0655]

Animal Generic Drug User Fee Act; Public Meeting; Request for
Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of meeting; request for comments.

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

    The Food and Drug Administration (FDA) is announcing the following
meeting: Animal Generic Drug User Fee Act. The topic to be discussed is
proposed recommendations for the reauthorization of the Animal Generic
Drug User Fee Act (AGDUFA II).
    Date and Time: The meeting will be held on December 18, 2012, from
1 p.m. to 4 p.m.
    Location: The meeting will be held at FDA's Metro Park North
Campus, 7519 Standish Pl., third floor, Meeting Room A, Rockville, MD
20855. There is parking near the building.
    Contact: Jacqueline Farmer, Center for Veterinary Medicine (HFV-
10), Food and Drug Administration, 7519 Standish Pl., Rockville, MD
20855,<PHONE_NUMBER>, FAX:<PHONE_NUMBER>, email:
<EMAIL_ADDRESS>    Registration and Requests for Oral Presentations: Send registration
information (including name, title, firm name, address, telephone, and
fax number), and written material and requests to make oral
presentations, to the contact person by December 11, 2012.
    If you need special accommodations due to a disability, please
contact Jacqueline Farmer at least 7 days in advance.
    Transcripts: Please be advised that as soon as a transcript is
available, it will be accessible at http://www.regulations.gov. It may
be viewed

at the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD. A
transcript will also be available in either hardcopy or on CD-ROM,
after submission of a Freedom of Information request. Written requests
are to be sent to the Division of Freedom of Information (ELEM-1029),
Food and Drug Administration, 12420 Parklawn Dr., Element Bldg.,
Rockville, MD 20857.
    Comments: Interested persons may submit either written comments
regarding this meeting to the Division of Dockets Management (see
Transcripts) or electronic comments to http://www.regulations.gov. It
is only necessary to send one set of comments. Identify comments with
the docket number found in brackets in the heading of this document.
Received comments may be seen in the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to
the docket at http://www.regulations.gov. So that FDA can consider
comments and revise the recommendations as necessary, we request that
comments be submitted to the docket by January 4, 2013.

SUPPLEMENTARY INFORMATION:

I. The AGDUFA Program

A. What is AGDUFA? What does it do?

    FDA considers the timely review of abbreviated new animal drug
applications (ANADAs) to be central to the Agency's mission to protect
and promote the public health. Prior to 2009, the timeliness and
predictability of the generic animal drug review program was a concern.
The Animal Generic Drug User Fee Act enacted in 2008 (Pub. L. 110-316;
hereinafter referred to as ``AGDUFA I'') amended the Federal Food,
Drug, and Cosmetic Act (the FD&C Act) to authorize the FDA's first-ever
generic animal drug user fee program. AGDUFA I provides FDA with
additional funds to enhance the performance of the generic animal drug
review process. Furthermore, the authorization of AGDUFA I enabled
FDA's continued assurance that generic animal drug products are safe
and effective, and enabled FDA's continued support for lower cost
alternatives to brand name drugs for consumers.
    Under AGDUFA I, FDA agreed to meet review performance goals for
certain submissions over 5 years from fiscal year (FY) 2009 through FY
2013. The purpose of establishing these review performance goals was to
expedite the review of ANADAs and reactivations, supplemental ANADAs,
and generic investigational new animal drug (JINAD) submissions and to
enable FDA to speed up the application review process for generic new
animal drugs without compromising the quality of the Agency's review.

B. AGDUFA Achievements

    AGDUFA I established increasingly stringent review performance
goals over a 5-year period from FY 2009 through FY 2013. Based on those
performance goals, in the final year of AGDUFA I (FY 2013) FDA has
agreed to review and act on 90 percent of the following submission
types within the specified timeframes:
     Original ANADAs and reactivations within 270 days after
the submission date.
     Administrative ANADAs within 100 days after the submission
date.
     Manufacturing supplemental ANADAs and reactivations within
270 days after the submission date.
     JINAD study submissions within 270 days after the
submission date.
     JINAD protocol submissions within 100 days after
submission date.
    In the 3 years of AGDUFA I review performance evaluated to date (FY
2009 to FY 2011) FDA has exceeded all performance goals for ANADAs,
manufacturing supplements, JINAD data submissions, and administrative
ANADAs. FDA did not meet the FY 2009 performance goal for JINAD
protocol submissions, with 86 percent reviewed by the goal for that
year but has exceeded the performance goal for JINAD protocol
submissions in FY 2010 and FY 2011. The additional resources provided
under AGDUFA I enabled FDA to completely eliminate the backlog of ANADA
and JINAD submissions by August 2010.
    FDA has published a number of reports that provide useful
background on AGDUFA I. AGDUFA-related Federal Register notices,
guidances, legislation, performance reports, and financial reports can
be found at: http://www.fda.gov/ForIndustry/UserFees/AnimalGenericDrugUserFeeActAGDUFA/default.htm.

II. Proposed AGDUFA II Recommendations

A. Enhancing the Process for Premarket Review

    We are proposing to maintain the AGDUFA I goals regarding work
queue procedures, timely meetings with industry, review of
administrative ANADAs, review of protocols without substantial data,
and amending similar applications and submissions. We are proposing the
following changes to the performance goals that AGDUFA I established to
further enhance the process for review of generic animal drug
applications.
    The Agency will review and act on 90 percent of non-administrative
ANADAs within 270 days after the submission date. An application is
incomplete if it would require additional data or information to enable
the Agency to complete a comprehensive review of the application and
reach a decision on the issue(s) presented in the application.
    The Agency will review and act on 90 percent of reactivated
applications:
     Within 190 days after the reactivated ANADA submission
date if the Agency determines that the deficiencies are not
substantial;
     Within 270 days after the reactivated ANADA submission
date if the Agency determines that the deficiencies are substantial or
new substantial information is provided.
    The Agency will review and act on 90 percent of manufacturing
supplemental ANADAs within 270 days after the submission date. A
submission is incomplete if it would require additional data or
information to enable the Agency to complete a comprehensive review of
the submission and reach a decision on the issue(s) presented in the
submission.
     If the Agency determines that the deficiencies are not
substantial for manufacturing supplements requiring prior approval
according to 21 CFR 514.8(b), the Agency will permit the manufacturing
supplements to be resubmitted as ``Supplement-Changes Being Effected in
30 Days'' as described in 21 CFR 514.8(b)(3).
     If the Agency determines that the deficiencies are
substantial or new substantial information is provided in the
resubmission, the Agency will review and act on 90 percent of
reactivated manufacturing supplements within 270 days after the
resubmission date.
    The Agency will review and act on 90 percent of JINAD study
submissions within 270 days after the submission date. A JINAD study
submission is incomplete if it would require additional data or
information to enable the Agency to complete a comprehensive review of
the submission and reach a decision on the issue(s) presented in the
submission.
    The Agency will review and act on 90 percent of resubmitted JINAD
study submissions:
     Within 90 days after the JINAD study resubmission date if
the Agency determines that the deficiencies are not substantial;
     Within 270 days after the JINAD study resubmission date if
the Agency

determines that the deficiencies are substantial or new substantial
information is provided in the resubmission.
    The Agency will permit comparability protocols as described in 21
CFR 514.8(b)(2)(v) to be submitted as protocols without substantial
data in a JINAD file. The Agency will continue to review and act on 90
percent of JINAD submissions consisting of protocols without
substantial data within 100 days after the submission date.
    The Agency will develop guidance for a two-phased Chemistry,
Manufacturing, and Controls technical section submission and review
process under the JINAD file by the end of FY 2014.
    The Agency will develop and implement a question based review
process for bioequivalence submissions by the end of FY 2016. At its
discretion, the Agency may extend the timeline for completion if
necessary, depending on available resources.
    To improve the timeliness and predictability of foreign preapproval
inspections (PAIs), sponsors may voluntarily submit, at the beginning
of the calendar year, a list of foreign manufacturing facilities that
are included in abbreviated animal drug applications, supplemental
animal drug applications, or investigational animal drug submissions
and may be subject to foreign PAIs for the following fiscal year.
    If such a list is voluntarily submitted, the sponsor should submit
a notification 30 days prior to submitting an abbreviated animal drug
application, an abbreviated supplemental animal drug application, or
generic investigational animal drug submission that informs the Agency
that the application includes a foreign manufacturing facility. Should
any changes to the annual list occur after its submission to the
Agency, the sponsor may provide the updated information to the Agency.

B. AGDUFA II Enhancements for a Modified Inflation Adjuster and
Workload Adjuster

    Similar to AGDUFA I, we agreed to a fixed inflation adjuster over
the 5-year period that results in the statutory revenues specified in
sections 741(b) and 741(g)(3) of FD&C Act (21 U.S.C. 379j-21(b) and
379-21(g)(3)).
    AGDUFA II also modifies the base years for calculating the workload
adjuster, as specified in the AGDUFA II performance goals letter, to
ensure that it adequately captures changes in FDA's workload during
AGDUFA II.

C. Impact of AGDUFA II Enhancements on User Fee Revenue

    The following table summarizes FY 2014 baseline and added funding
to support AGDUFA II program, as well as the AGDUFA II total 5-year
revenue:

------------------------------------------------------------------------
                     Financial baseline                        Dollars
------------------------------------------------------------------------
FY 2014 Base Revenue \1\...................................    6,478,000
One-Time Information Technology (IT) Funding...............      850,000
                                                            ------------
    Total Statutory Revenue for FY 2014....................    7,328,000
------------------------------------------------------------------------
                         Total Financial Funding
------------------------------------------------------------------------
Total 5-Year Revenue.......................................   38,100,000
------------------------------------------------------------------------
\1\ For each year in FY 2015 to FY 2018, the annual statutory revenue
  amounts established in section 741(b) of the FD&C Act may be further
  adjusted by the workload adjuster for FY 2015 to FY 2018 user fee
  revenues.

    The total 5-year revenue for AGDUFA I was $27,100,000. The total 5-
year revenue for AGDUFA II will be $38,100,000, which also includes
one-time IT funding in the amount of $850,000 for FY 2014.
    Additionally, the fee revenue distribution has been modified from
30 percent in application fees, 35 percent in product fees, and 35
percent in sponsor fees under AGDUFA I to 25 percent in application
fees, 37.5 percent in product fees, and 37.5 percent in sponsor fees
under AGDUFA II. The purpose of changing the fee distribution is to
increase the revenue stream stability and reduce application fee costs.

III. What information should you know about the meeting?

    We will convene a public meeting to hear the public's views on the
proposed recommendations for reauthorization of AGDUFA I. The public
meeting will be held on December 18, 2012, at FDA's Metro Park North
Campus (see Location). The meeting will include a presentation by FDA,
and we will also provide an opportunity for other organizations and
individuals to make presentations at the meeting or to submit written
comments to the docket. So that FDA can consider comments and revise
the recommendations as necessary, we request that comments be submitted
to the docket by January 4, 2013.

    Dated: December 3, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-29499 Filed 11-26-12; 4:15 pm]
BILLING CODE 4160-01-P


[Federal Register Volume 78, Number 97 (Monday, May 20, 2013)]
[Notices]
[Pages 29367-29368]
[FR Doc No: 2013-11975]

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ENVIRONMENTAL PROTECTION AGENCY

[FRL-9815-6]

Access to Confidential Business Information by ABT Associates,
Incorporated; Perry Johnson Registrars, Inc.; SGS North America, Inc.;
SAI Global, Inc.; Orion Registrar, Inc.; NSF-ISR International, and
T[Uuml]V S[Uuml]D America, Inc.

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of Access to Data and Request for Comments.

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

SUMMARY: EPA will authorize its contractor ABT Associates, Incorporated
(ABT) and six (6) auditing organizations: Perry Johnson Registrars,
Inc.; SGS North America, Inc.; SAI Global; Orion Registrar, Inc.; NSF-
ISR International, and T[Uuml]V S[Uuml]D America, Inc., also known as
the ``Certifying Bodies'', to access Confidential Business Information
(CBI) which has been submitted to EPA under the authority of all
sections of the Resource Conservation and Recovery Act (RCRA) of 1976,
as amended. EPA has issued regulations that outline business
confidentiality provisions for the Agency and require all EPA Offices
that receive information designated by the submitter, as CBI to abide
by these provisions.

DATES: Access to confidential data submitted to EPA will occur no
sooner than May 30, 2013.

FOR FURTHER INFORMATION CONTACT: LaShan Haynes, Document Control
Officer, Office of Resource Conservation and Recovery, (5305P), U.S.
Environmental Protection Agency, 1200 Pennsylvania Avenue NW.,
Washington, DC 20460,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

1. Access to Confidential Business Information

    Under EPA Contract No. EP-W-10-10054, Task Order 54, ABT
Associates, Incorporated will provide technical support to the Office
of Resource Conservation and Recovery (ORCR), Resource Conservation and
Sustainability Division (RCSD) as it conducts a study of the
implementation of two currently used electronics recycling
certification programs in the U.S.: The Responsible Recycling Practices
(R2) and e-Stewards Standard for Responsible Recycling and Reuse of
Electronic Equipment (e-Stewards). Contractor support from ABT will be
required as interviews with stakeholders are conducted; observation of
approximately nine (9) audits of electronic recycling facilities being
voluntarily performed by the Certifying Bodies, who are authorized to
certify the standards. ABT will assist with developing a report
identifying the areas of strength in the programs and implementation
process and recommend any improvements where appropriate. Some of the
data collected voluntarily from the facilities, may be claimed by
industry to contain auditing tools, ownership/operation agreements,
amounts and types of e-waste processed; and environmental health and
safety plans; and asset destruction methods and policies. In accordance
with the provisions of 40 CFR part 2, subpart B, ORCR has established
policies and procedures for handling information collected from
industry, under the authority of RCRA, including RCRA Confidential
Business Information Security Manuals. ABT Associates, Incorporated
shall protect from unauthorized disclosure all information designated
as confidential and shall abide by all RCRA CBI requirements, including
procedures outlined in the RCRA CBI Security Manual. The U.S.
Environmental Protection Agency has issued regulations (40 CFR Part 2,
Subpart B) that outline business confidentiality provisions for the
Agency and require all EPA Offices that receive information designated
by the submitter as CBI to abide by these provisions. ABT Associates,
Incorporated and the Certifying Bodies will be authorized to have
access to RCRA CBI under the EPA ``Contractor Requirements for the
Control and Security of RCRA Confidential Business Information Security
Manual.''
    EPA is issuing this notice to inform all submitters of information
under all sections of RCRA that ABT Associates, Incorporated, and the
Certifying Bodies, under the contract may have access to RCRA CBI.
Access to RCRA CBI under this contract will take place at ABT
Associates facility located in Bethesda, Maryland, and when necessary,
EPA Headquarters only. Contractor personnel at each location will be
required to sign non-disclosure agreements and will be briefed on
appropriate security

procedures before they are permitted access to confidential
information.

    Dated: May 1, 2013.
Suzanne Rudzinski,
Director, Office of Resource Conservation & Recovery.
[FR Doc. 2013-11975 Filed 5-17-13; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 85, Number 189 (Tuesday, September 29, 2020)]
[Notices]
[Pages 60999-61001]
[FR Doc No: 2020-21452]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0987]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Generic Clearance for the Collection of Qualitative
Data on Tobacco Products and Communications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information, and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on generic clearance for the collection of
qualitative data on tobacco products and communications.

DATES: Submit either electronic or written comments on the collection
of information by November 30, 2020.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before November 30, 2020. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of November 30, 2020. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.

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-2014-N-0987 for ``Generic Clearance for the Collection of
Qualitative Data on Tobacco Products and Communications.'' Received
comments, those filed in a timely manner (see ADDRESSES), 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,<PHONE_NUMBER>.
     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.govinfo.gov/content/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,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Generic Clearance for the Collection of Qualitative Data on Tobacco
Products and Communications

OMB Control Number 0910-0796--Extension

    Under section 1003(d)(2)(D) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 393(d)(2)(D)), FDA is authorized to conduct educational
and public information programs.
    In conducting studies relating to the regulation and communications
related to tobacco products, FDA will need to employ formative
qualitative research including focus groups, usability testing, and/or
in-depth interviews (IDIs) to assess knowledge and perceptions about
tobacco-related topics with specific target audiences. The information
collected will serve three major purposes. First, formative research
will provide critical knowledge about target audiences. FDA must first
understand people's knowledge and perceptions about tobacco related
topics prior to developing survey/research questions as well as stimuli
for experimental studies. Second, by collecting communications
usability information, FDA will be able to serve and respond to the
ever-changing demands of consumers of tobacco products. Additionally,
we will be able to determine the best way to present messages. Third,
initial testing will allow FDA to assess consumer understanding of
survey/research questions and study stimuli. Focus groups and/or IDIs
with a sample of the target audience will allow FDA to refine the
survey/research questions and study stimuli while they are still in the
developmental stage. FDA will collect, and interpret information
gathered through this generic clearance in order to: (1) Better
understand characteristics of the target audience--its perceptions,
knowledge, attitudes, beliefs, and behaviors--and use these in the
development of appropriate survey/research questions, study stimuli, or
communications; (2) more efficiently and effectively design survey/
research questions and study stimuli; and (3) more efficiently and
effectively design experimental studies.
    FDA is requesting approval of an extension of this generic
clearance for collecting information using qualitative methods (i.e.,
individual interviews, small group discussions, and focus groups) for
studies involving all tobacco products regulated by FDA. This
information will be used as a first step to explore concepts of
interest and assist in the development of quantitative study proposals,
complementing other important research efforts in the Agency. This
information may also be used to help identify and develop communication
messages, which may be used in education campaigns. Focus groups play
an important role in gathering information because they allow for an
in-depth understanding of individuals' attitudes, beliefs, motivations,
and feelings. Focus group

research serves the narrowly defined need for direct and informal
public opinion on a specific topic.
    FDA estimates the burden of this collection of information as
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                   Number of
       Type of interview           Number of     responses per   Total annual    Average burden     Total hours
                                  respondents     respondent       responses      per response
----------------------------------------------------------------------------------------------------------------
In-Person Individual In-depth            1,092               1           1,092  1...............           1,092
 Interviews.
In-depth Interview (IDI)                 1,800               1           1,800  0.083 (5                     150
 Screener.                                                                       minutes).
Focus Group Screener..........          19,385               1          19,385  0.25 (15                   4,846
                                                                                minutes).
Focus Group Interviews........           5,897               1           5,897  1.5.............           8,846
                               ---------------------------------------------------------------------------------
    Total.....................  ..............  ..............  ..............  ................          14,934
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    The number of respondents to be included in each new pretest may
vary, depending on the nature of the material or message being tested
and the target audience. Table 1 provides examples of the types of
studies that may be administered and estimated burden levels during the
3-year period. Time to read, view, or listen to the message being
tested is built into the ``Hours per Response'' figures. Our estimated
burden for the information collection reflects an overall increase of
5,641 hours and a corresponding increase of 16,585 responses. We
attribute this adjustment to the number of study responses used during
the current approval and now estimated for the next 3 years.

    Dated: September 18, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2020-21452 Filed 9-28-20; 8:45 am]
BILLING CODE 4164-01-P