[Federal Register Volume 81, Number 158 (Tuesday, August 16, 2016)]
[Notices]
[Pages 54634-54639]
[FR Doc No: 2016-19442]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-78533; File No. SR-NASDAQ-2016-086]

Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Order
Granting Approval of a Proposed Rule Change, as Modified by Amendment
No. 1 Thereto, To List and Trade the Shares of the VanEck Vectors Long/
Flat Commodity ETF

August 10, 2016.

I. Introduction

    On June 10, 2016, The NASDAQ Stock Market LLC (``Nasdaq'' or
``Exchange'') filed with the Securities and Exchange Commission
(``Commission''), pursuant to Section 19(b)(1) of the Securities
Exchange Act of 1934 (``Act'' or ``Exchange Act''),\1\ and Rule 19b-4
thereunder,\2\ a proposed rule change to list and trade shares
(``Shares'') of the VanEck Vectors Long/Flat Commodity ETF (``Fund'')
under Nasdaq Rule 5735. The Commission

published notice of the proposed rule change in the Federal Register on
June 30, 2016.\3\ On July 15, 2016, the Exchange submitted Amendment
No. 1 to the proposed rule change.\4\ The Commission received no
comments on the proposed rule change. This order grants approval of the
proposed rule change, as modified by Amendment No. 1 thereto.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 78150 (Jun. 24,
2016), 81 FR 42768 (``Notice'').
    \4\ In Amendment No. 1 the Exchange clarified the usage of the
defined terms used for commodities instruments in the portfolio and
clarified the application of the percentage limitation on equity
securities that trade in markets that are not members of the
Intermarket Surveillance Group (``ISG'') or are not parties to a
comprehensive surveillance sharing agreement with the Exchange.
Amendment No. 1 is available at https://www.sec.gov/comments/sr-nasdaq-2016-086/nasdaq2016086-1.pdf. Because Amendment No. 1 to the
proposed rule change does not materially alter the substance of the
proposed rule change or raise unique or novel regulatory issues,
Amendment No. 1 is not subject to notice and comment.
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II. Exchange's Description of the Proposal

    The Exchange proposes to list and trade the Shares under Nasdaq
Rule 5735, which governs the listing and trading of Managed Fund Shares
on the Exchange. The Shares will be offered by VanEck Vectors ETF Trust
(``Trust''), which was organized as a Delaware statutory trust on March
15, 2001.\5\ The investment adviser and the administrator to the Fund
will be Van Eck Absolute Return Advisers Corporation (``Adviser''), and
the Fund currently does not intend to use a sub-adviser.\6\ Van Eck
Securities Corporation (``Distributor'') will be the distributor of the
Fund's Shares. The Bank of New York Mellon will act as the custodian of
the Fund's assets and provide transfer agency and fund accounting
services to the Fund.
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    \5\ The Trust is registered with the Commission as an investment
company and has filed a registration statement on Form N-1A
(``Registration Statement'') with the Commission. See Registration
Statement on Form N-1A for the Trust, dated November 12, 2015 (File
Nos. 333-123257 and 811-10325). In addition, the Exchange states
that the Trust has obtained certain exemptive relief under the
Investment Company Act of 1940 (``1940 Act''). See Investment
Company Act Release No. 29571 (Jan. 24, 2011) (File No. 812-13601).
    \6\ According to the Exchange, the Adviser is not a broker-
dealer, although it is affiliated with Van Eck Securities
Corporation, a broker-dealer, and has implemented a fire wall with
respect to its broker-dealer affiliate regarding access to
information concerning the composition and/or changes to a
portfolio. In the event (a) the Adviser becomes newly affiliated
with a broker-dealer or registers as a broker-dealer, or (b) any new
adviser or sub-adviser to the Fund is a registered broker-dealer or
becomes affiliated with a broker-dealer, it will implement a fire
wall with respect to its relevant personnel or such broker-dealer
affiliate, if applicable, regarding access to information concerning
the composition of, and changes to, the portfolio. In addition,
personnel who make decisions on each Fund's portfolio composition
will be subject to procedures designed to prevent the use and
dissemination of material, non-public information regarding such
portfolio.
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    The Exchange has made the following representations and statements
in describing the Fund and its investment strategies, including the
Fund's portfolio holdings and investment restrictions.\7\
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    \7\ The Commission notes that additional information regarding
the Trust, the Fund, and the Shares, including investment
strategies, risks, net asset value (``NAV'') calculation, creation
and redemption procedures, fees, Fund holdings disclosure policies,
distributions, and taxes, among other information, is included in
the Notice, as modified by Amendment No. 1 thereto, and the
Registration Statement, as applicable. See Notice, Amendment No. 1
to the proposed rule change, and Registration Statement, supra notes
3, 4, and 5, respectively, and accompanying text.
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A. Exchange's Description of the Fund's Principal Investments

    The Fund's investment objective will be to seek long-term capital
appreciation while seeking to manage volatility and reduce downside
risk during sustained market declines. The Fund will seek to achieve
its investment objective by investing, under normal circumstances, in
exchange-traded commodity futures contracts and, under certain limited
circumstances, other commodity-linked instruments as set forth in
``Other Investments'' hereunder (collectively, ``Commodities
Instruments''). The Fund will invest in Commodities Instruments
primarily through a wholly-owned subsidiary of the Fund organized under
the laws of the Cayman Islands (``Subsidiary'').\8\
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    \8\ The Subsidiary will be wholly-owned and controlled by the
Fund and will be advised by the Adviser. The Exchange represents
that the Fund's investment in the Subsidiary may not exceed 25% of
the value of the Fund's total assets at each quarter-end of the
Fund's fiscal year. The Fund's investment in the Subsidiary is
expected to provide the Fund with exposure to Commodities
Instruments within the limits of the federal tax laws, which limit
the ability of investment companies like the Fund to invest directly
in such instruments. The Subsidiary will have the same investment
objective as the Fund and will follow the same general investment
policies and restrictions, except that unlike the Fund, it may
invest without limit in Commodities Instruments. In addition, the
Subsidiary will not be registered under the 1940 Act and will not be
directly subject to its investor protections, except as noted in the
Registration Statement. The Trust's board (``Board'') will have
oversight responsibility for the investment activities of the Fund,
including its investment in the Subsidiary, and the Fund's role as
the sole shareholder of the Subsidiary. The Adviser will receive
certain fees for managing the Subsidiary's assets, and the Adviser
will waive or credit such amounts against the fees payable to the
Adviser by the Fund. It is expected that the Subsidiary will become
party to the existing custody agreement, transfer agency agreement
and accounting agreement of the Trust and Fund.
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    The Fund (directly or indirectly through the Subsidiary) will
normally invest in exchange-traded commodity futures contracts that are
components of the Morningstar[supreg] Long/Flat Commodity Index\SM\
(``Benchmark''), an index composed of futures contracts on 20 heavily
traded commodities across the energy, agriculture, industrial metals,
precious metals, and livestock sectors. The Adviser will employ a
rules-based investment approach when selecting Commodities Instruments
based upon momentum characteristics of the Commodities Instruments.
Commodities Instruments are assessed on a monthly basis by comparing
current prices to 12-month moving averages. The Fund's positions will
be either long \9\ or flat.\10\ The Fund intends to take long positions
in those Commodities Instruments whose prices are above their 12-month
moving average. Conversely, the Fund intends to take flat positions to
manage volatility and reduce downside risk for those Commodities
Instruments whose prices are below their 12-month moving average. The
Fund will not be an ``index tracking'' ETF and may not always invest in
all of the Benchmark's components, or in the same proportion, and it
may invest in Commodities Instruments outside the Benchmark.\11\
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    \9\ For the purposes of this filing, a ``long'' position is a
position that will increase in market price if the price of the
commodity futures contract is rising during the period when the
position is open.
    \10\ For the purposes of this filing, a ``flat'' position is a
position that will not increase or decrease in market price whether
the price of the commodity futures contract to which it relates is
rising or falling.
    \11\ See Notice, supra note 3, 81 FR at 42770 (providing, in
table format, detailed information relating to each of the commodity
futures contracts in the Benchmark, including each instrument's
trading hours, futures exchange, and ticker symbol). The Exchange
represents that all of the futures exchanges represented in the
Benchmark are members of ISG.
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B. Exchange's Description of the Fund's Non-Principal Investments

    As noted above, the Fund intends to invest first in exchange-traded
commodity futures contracts. However, in the event the Fund reaches the
position limits applicable to one or more exchange-traded commodity
futures contracts or a futures exchange imposes limitations on the
Fund's ability to maintain or increase its positions in an exchange-
traded commodity futures contract after reaching accountability levels
or a price limit is in effect on an exchange-traded commodity futures
contract during the last 30 minutes of its regular trading session, the
Fund's intention is to invest first in commodity-based swap agreements
cleared through a central clearing house or the clearing house's
affiliate (``Cleared Swaps'') to the extent

permitted under the position limits applicable to Cleared Swaps and
appropriate in light of the liquidity in the Cleared Swaps market, and
then, using its commercially reasonable judgment, in forward contracts
on commodities, exchange-traded options on futures contracts, and
commodity-based swaps other than Cleared Swaps (collectively, including
Cleared Swaps, ``Other Commodity Instruments'').
    The Fund (and the Subsidiary, as applicable) expects to invest its
remaining assets in any one or more of the following: U.S. government
securities; \12\ money market funds; cash and other cash equivalents;
\13\ treasury inflation-protected securities; sovereign debt
obligations of non-U.S. countries; and repurchase agreements that
provide liquidity, serve as margin, or collateralize the Fund's or the
Subsidiary's investments in exchange-traded commodity futures
contracts.
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    \12\ Such securities will include securities that are issued or
guaranteed by the U.S. Treasury, by various agencies of the U.S.
government, or by various instrumentalities, which have been
established or sponsored by the U.S. government. U.S. Treasury
obligations are backed by the ``full faith and credit'' of the U.S.
government. Securities issued or guaranteed by federal agencies and
U.S. government-sponsored instrumentalities may or may not be backed
by the full faith and credit of the U.S. government.
    \13\ Cash equivalents will include banker's acceptances,
commercial paper, and certificates of deposit.
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    The Fund also may invest directly in exchange-traded funds
(``ETFs''),\14\ exchange-traded closed end funds (to the extent
permitted by the 1940 Act and certain exemptive relief issued in
thereunder), and exchange-traded notes (``ETNs'') that provide exposure
to commodities.\15\ The Fund may also invest in commodity-related
foreign and domestic equity securities.\16\
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    \14\ ETFs in which the Fund invests will be listed and traded in
the U.S. on registered exchanges. The ETFs in which the Fund will
invest include Index Fund Shares (as described in Nasdaq Rule 5705),
Portfolio Depositary Receipts (as described in Nasdaq Rule 5705),
and Managed Fund Shares (as described in Nasdaq Rule 5735). The
shares of ETFs in which the Fund may invest will be limited to
securities that trade in markets that are members of the ISG, which
includes all U.S. national securities exchanges, or exchanges that
are parties to a comprehensive surveillance sharing agreement with
the Exchange. The Exchange represents that the Fund will not hold
inverse, leveraged, and inverse leveraged ETFs. See Notice, supra
note 3, 81 FR at 42770, n.14.
    \15\ ETNs in which the Fund invests will be listed and traded in
the U.S. on registered exchanges. The ETNs in which the Fund will
invest include Securities Linked to the Performance of Indexes and
Commodities, Including Currencies (as described in Nasdaq Rule
5710), and Index-Linked Exchangeable Notes (as described in Nasdaq
Rule 5711). The Exchange represents that the Fund will not hold
inverse, leveraged, and inverse leveraged ETNs. See id.
    \16\ Commodity-related foreign and domestic equity securities
will be comprised of exchange-traded common stocks of companies that
operate in commodities, natural resources and energy businesses, and
in associated businesses, as well as companies that provide services
or have exposure to such businesses.
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C. Exchange's Descriptions of the Fund's Investment Restrictions

    According to the Exchange, the Fund may not make loans, except that
it may (i) lend portfolio securities, (ii) enter into repurchase
agreements, (iii) purchase all or a portion of an issue of debt
securities, bank loan or participation interests, bank certificates of
deposit, bankers' acceptances, debentures or other securities, whether
or not the purchase is made upon the original issuance of the
securities, and (iv) participate in an interfund lending program with
other registered investment companies, all in accordance with the 1940
Act. In addition, the Fund may not borrow money, except as permitted
under the 1940 Act, and as interpreted or modified by regulation from
time to time. The Fund also may not issue senior securities, except as
permitted under the 1940 Act, and as interpreted or modified by
regulation from time to time.
    The Fund may hold up to an aggregate amount of 15% of its net
assets in illiquid assets (calculated at the time of investment).\17\
The Fund will monitor its portfolio liquidity on an ongoing basis to
determine whether, in light of current circumstances, an adequate level
of liquidity is being maintained, and will consider taking appropriate
steps in order to maintain adequate liquidity if, through a change in
values, net assets, or other circumstances, more than 15% of the Fund's
net assets are held in illiquid assets. Illiquid assets include
securities subject to contractual or other restrictions on resale and
other instruments that lack readily available markets as determined in
accordance with Commission staff guidance. An illiquid security is
generally considered to be a security that cannot be sold or disposed
of in the ordinary course of business within seven days at or near its
carrying value.
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    \17\ In reaching liquidity decisions, the Adviser may consider
factors such as but not limited to the following: The frequency of
trades and quotes for the security; the number of dealers wishing to
purchase or sell the security and the number of other potential
purchasers; dealer undertakings to make a market in the security;
and the nature of the security and the nature of the marketplace in
which it trades (e.g., the time needed to dispose of the security,
the method of soliciting offers and the mechanics of transfer).
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    The Fund may not purchase any security if, as a result of that
purchase, 25% or more of its total assets would be invested in
securities of issuers having their principal business activities in the
same industry. This limit does not apply to securities issued or
guaranteed by the U.S. Government, its agencies or instrumentalities,
or securities of other investment companies.

III. Discussion and Commission Findings

    After careful review, the Commission finds that the Exchange's
proposal to list and trade the Shares is consistent with the Exchange
Act and the rules and regulations thereunder applicable to a national
securities exchange.\18\ In particular, the Commission finds that the
proposed rule change, as modified by Amendment No. 1 thereto, is
consistent with Section 6(b)(5) of the Exchange Act,\19\ which
requires, among other things, that the Exchange's rules be 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 a national market system,
and, in general, to protect investors and the public interest.
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    \18\ In approving this proposed rule change, the Commission has
considered the proposed rule's impact on efficiency, competition,
and capital formation. See 15 U.S.C. 78c(f).
    \19\ 15 U.S.C. 78f(b)(5).
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    The Commission also finds that the proposal to list and trade the
Shares on the Exchange is consistent with Section 11A(a)(1)(C)(iii) of
the Exchange Act,\20\ which sets forth the finding of Congress that it
is in the public interest and appropriate for the protection of
investors and the maintenance of fair and orderly markets to assure the
availability to brokers, dealers, and investors of information with
respect to quotations for and transactions in securities. According to
the Exchange, quotation and last-sale information for the Shares will
be available via Nasdaq proprietary quote and trade services, as well
as in accordance with the Unlisted Trading Privileges and the
Consolidated Tape Association plans for the Shares. Quotation and last-
sale information for any underlying exchange-traded equity will also be
available via the quote and trade service of their respective primary
exchanges, as well as in accordance with the Unlisted Trading
Privileges and the Consolidated Tape Association plans. Quotation and
last-sale information for any underlying exchange-traded options will
also be available via the quote and trade service of their respective
primary exchanges. Quotation and last-sale information for any
underlying exchange-traded futures contracts will be available via the
quote and trade service of their respective

primary exchanges. Information on the Morningstar Long/Flat Commodity
Index\SM\ will be available on the Morningstar Indexes Web site.
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    \20\ 15 U.S.C. 78k-1(a)(1)(C)(iii).
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    On each business day, before commencement of trading in Shares in
the Regular Market Session on the Exchange, the Fund will disclose on
its Web site the ``Disclosed Portfolio,'' as defined in Nasdaq Rule
5735(c)(2), that will form the basis for the Fund's calculation of NAV
at the end of the business day.\21\ In addition, an estimated value of
the Fund, defined in Exchange Rule 5735(c)(3) as ``Intraday Indicative
Value,'' that reflects an estimated intraday value of the Fund's
portfolio (including the Subsidiary's portfolio), will be disseminated.
The Intraday Indicative Value, available on the NASDAQ OMX Information
LLC proprietary index data service \22\ will be based upon the current
value for the components of the Disclosed Portfolio and will be updated
and widely disseminated by one or more major market data vendors and
broadly displayed at least every 15 seconds during the Regular Market
Session.\23\ The NAV of the Fund will be determined each business day
as of the close of trading (ordinarily 4:00 p.m. Eastern Time) on
Nasdaq.\24\ In addition, a basket composition file, which includes the
security names and quantities required to be delivered in exchange for
the Fund's Shares, together with estimates and actual cash components,
will be publicly disseminated daily prior to the opening of the
Exchange via NSCC.
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    \21\ Under accounting procedures to be followed by the Fund,
trades made on the prior business day (``T'') will be booked and
reflected in NAV on the current business day (``T+1''). Accordingly,
the Fund will be able to disclose at the beginning of the business
day the portfolio that will form the basis for the NAV calculation
at the end of the business day. 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
percentage weighting of the holding in the Fund's portfolio. The Web
site information will be publicly available at no charge.
    \22\ The Exchange states that the NASDAQ OMX Global Index Data
Service (``GIDS'') is the NASDAQ OMX global index data feed service,
offering real-time updates, daily summary messages, and access to
widely followed indexes and Intraday Indicative Values for ETFs. See
Notice, supra note 3, 81 FR at 42773, n.26.
    \23\ The Exchange represents that the dissemination of the
Intraday Indicative Value, together with the Disclosed Portfolio,
will allow investors to determine the value of the underlying
portfolio of the Fund on a daily basis and will provide a close
estimate of that value throughout the trading day. See id. at 42773.
    \24\ According to the Exchange, ETFs, exchange-traded closed-end
funds, ETNs, and commodity-related foreign and domestic equity
securities, will be based on the securities' closing prices on local
markets, when available. Due to the time differences between the
United States and certain countries, securities on these non-U.S.
exchanges may not trade at times when Shares of the Fund will trade.
In the absence of a last reported sales price, or if no sales were
reported, and for other assets for which market quotes are not
readily available, values may be based on quotes obtained from a
quotation reporting system, established market makers or by an
outside independent pricing service using data reflecting the
earlier closing of the principal markets for those securities. U.S.
government securities, treasury inflation-protected securities, and
sovereign debt obligations of non-U.S. countries will normally be
valued on the basis of quotes from brokers or dealers, established
market makers, or an outside independent pricing service. Short-term
investments purchased with a remaining maturity of 60 days or less,
including repurchase agreements and cash equivalents, will be valued
on the basis of quotes from broker dealers, established major market
makers, an independent pricing service, or at amortized cost. Money
market funds will be valued at their reported closing NAV. Futures
contracts and options on futures contracts, which are traded on
exchanges, will be valued at the current settle price for like
contracts acquired on the day on which the futures contract will be
valued as of the close of such exchanges. Other Commodity
Instruments not traded on exchanges will generally be valued daily
based upon quotations from market makers or by a pricing service and
in accordance with the Trust's valuation policies and procedures.
Prices obtained by an outside independent pricing service may use
information provided by market makers or estimates of market values
obtained from yield data related to investments or securities with
similar characteristics and may use a computerized grid matrix of
securities and its evaluations in determining what it believes is
the fair value of the portfolio securities. If a market quotation
for a security is not readily available or the Adviser believes it
does not otherwise accurately reflect the market value of the
security at the time the Fund calculates its NAV, the security will
be fair valued by the Adviser in accordance with the Trust's
valuation policies and procedures approved by the Board.
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    Intra-day, executable price quotations on the exchange-traded
assets held by the Fund and the Subsidiary, including futures
contracts, options on futures contracts, ETFs, ETNs, closed-end funds,
and foreign and domestic equity securities are expected to be available
on the exchange on which they are traded. Intra-day, executable price
quotations on swaps, money market funds, forward contracts, U.S.
government securities, cash and other cash equivalents, treasury
inflation-protected securities, sovereign debt obligations of non-U.S.
countries, and repurchase agreements will be available from major
broker-dealer firms. Intra-day price information will also be available
through subscription services, such as Bloomberg and Reuters.
Additionally, the Trade Reporting and Compliance Engine (``TRACE'') of
the Financial Industry Regulatory Authority (``FINRA'') will be a
source of price information for certain fixed income securities held by
the Fund.
    The Commission believes that the proposal to list and trade the
Shares is reasonably designed to promote fair disclosure of information
that may be necessary to price the Shares appropriately and to prevent
trading when a reasonable degree of transparency cannot be assured. The
Exchange will obtain a representation from the issuer of the Shares
that the NAV per Share will be calculated daily and that the NAV and
the Disclosed Portfolio will be made available to all market
participants at the same time. Nasdaq will halt trading in the Shares
under the conditions specified in Nasdaq Rules 4120 and 4121, including
the trading pauses under Nasdaq Rules 4120(a)(11) and (12). Trading may
be halted because of market conditions or for reasons that, in the view
of the Exchange, make trading in the Shares inadvisable.\25\ Trading in
the Shares also will be subject to Rule 5735(d)(2)(D), which sets forth
circumstances under which trading in the Shares of the Fund may be
halted. The Exchange represents that it has a general policy
prohibiting the distribution of material, non-public information by its
employees. Further, the Commission notes that the Reporting Authority
\26\ that provides the Disclosed Portfolio must implement and maintain,
or be subject to, procedures designed to prevent the use and
dissemination of material, non-public information regarding the actual
components of the portfolio.\27\ In addition, Nasdaq Rule 5735(g)
further requires that personnel who make decisions on the open-end
fund's portfolio composition must be subject to procedures designed to
prevent the use and dissemination of material, non-public information
regarding the open-end fund's portfolio. The Exchange states that the
Adviser is affiliated with the Distributor, a broker-dealer, and has
implemented a fire wall with respect to its broker-dealer affiliate
regarding access to information concerning the composition of, and
changes to, the portfolio.\28\
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    \25\ These may include: (1) The extent to which trading is not
occurring in the securities and other assets constituting the
Disclosed Portfolio of the Fund and the Subsidiary; or (2) whether
other unusual conditions or circumstances detrimental to the
maintenance of a fair and orderly market are present.
    \26\ Nasdaq Rule 5730(c)(4) defines ``Reporting Authority.''
    \27\ See Nasdaq Rule 5735(d)(2)(B)(ii).
    \28\ See supra note 6. The Exchange further represents that an
investment adviser to an open-end fund is required to be registered
under the Investment Advisers Act of 1940 (``Advisers Act''). As a
result, the Adviser and its related personnel are subject to the
provisions of Rule 204A-1 under the Advisers Act relating to codes
of ethics. This Rule requires investment advisers to adopt a code of
ethics that reflects the fiduciary nature of the relationship to
clients as well as compliance with other applicable securities laws.
Accordingly, procedures designed to prevent the communication and
misuse of non-public information by an investment adviser must be
consistent with Rule 204A-1 under the Advisers Act. In addition,
Rule 206(4)-7 under the Advisers Act makes it unlawful for an
investment adviser to provide investment advice to clients unless
such investment adviser has (i) adopted and implemented written
policies and procedures reasonably designed to prevent violation, by
the investment adviser and its supervised persons, of the Advisers
Act and the Commission rules adopted thereunder; (ii) implemented,
at a minimum, an annual review regarding the adequacy of the
policies and procedures established pursuant to subparagraph (i)
above and the effectiveness of their implementation; and (iii)
designated an individual (who is a supervised person) responsible
for administering the policies and procedures adopted under
subparagraph (i) above.

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    The Exchange represents that the Shares are deemed to be equity
securities, thus rendering trading in the Shares subject to the
Exchange's existing rules governing the trading of equity securities.
In support of this proposal, the Exchange has made representations,
including the following:
    (1) The Shares will conform to the initial and continued listing
criteria under Nasdaq Rule 5735.\29\
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    \29\ See Notice, supra note 3, 81 FR at 42774.
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    (2) Trading in the Shares will be subject to the existing trading
surveillances, administered by both Nasdaq and also the FINRA on behalf
of the Exchange, and 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 applicable federal securities
laws.\30\
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    \30\ See id. 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. See
id. at 42774, n.28.
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    (3) FINRA, on behalf of the Exchange, will communicate as needed
regarding trading information it can obtain relating to the Shares,
other exchange-traded securities and other assets held by the Fund and
the Subsidiary, which include exchange-traded commodity-related equity
securities, exchange-traded futures contracts, exchange-traded options
on futures contracts, ETNs, ETFs and exchange-traded closed-end funds,
with other markets and other entities that are members of the ISG, and
FINRA may obtain trading information regarding trading in the Shares,
and such exchange-traded securities and other assets held by the Fund
and the Subsidiary from such markets and other entities. In addition,
the Exchange may obtain information regarding trading in the Shares,
and such exchange-traded securities and other assets held by the Fund
and the Subsidiary from markets and other entities that are members of
ISG, which includes securities and futures exchanges, or with which the
Exchange has in place a comprehensive surveillance sharing agreement.
Moreover, FINRA, on behalf of the Exchange, will be able to access, as
needed, trade information for certain fixed income securities held by
the Fund reported to FINRA's TRACE.\31\
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    \31\ See id. at 42774.
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    (4) With respect to the exchange-traded commodity futures contracts
and options on futures contracts (if applicable) held, not more than
10% of the weight of such futures contracts and options on futures
contracts in the aggregate shall consist of instruments whose principal
trading market is not a member of the ISG or is a market with which the
Exchange does not have a comprehensive surveillance sharing agreement.
In addition, not more than 10% of the equity securities (including
shares of ETFs, closed-end funds, and commodity-related foreign and
domestic equity securities) and ETNs in which the Fund may invest will,
in the aggregate, be invested in securities that trade in markets that
are not members of the ISG or are not parties to a comprehensive
surveillance sharing agreement with the Exchange.
    (5) The Exchange has appropriate rules to facilitate transactions
in the Shares during all trading sessions.
    (6) Prior to the commencement of trading, the Exchange will inform
its members in an Information Circular of the special characteristics
and risks associated with trading the Shares. Specifically, the
Information Circular will discuss the following: (a) The procedures for
purchases and redemptions of Shares in Creation Units (and that Shares
are not individually redeemable); (b) Nasdaq Rule 2111A, which imposes
suitability obligations on Nasdaq members with respect to recommending
transactions in the Shares to customers; (c) how and by whom the
information regarding the Intraday Indicative Value and the Disclosed
Portfolio is disseminated; (d) the risks involved in trading the Shares
during the Pre-Market and Post-Market Sessions when an updated Intraday
Indicative Value will not be calculated or publicly disseminated; (e)
the requirement that members deliver a prospectus to investors
purchasing newly issued Shares prior to or concurrently with the
confirmation of a transaction; and (f) trading information.
    (7) For initial and/or continued listing, the Fund and the
Subsidiary must be in compliance with Rule 10A-3 under the Exchange
Act.\32\
---------------------------------------------------------------------------

    \32\ See 17 CFR 240.10A-3.
---------------------------------------------------------------------------

    (8) The Fund will not hold inverse, leveraged, and inverse
leveraged ETFs or ETNs.\33\
---------------------------------------------------------------------------

    \33\ See supra notes 14 and 15.
---------------------------------------------------------------------------

    (9) As noted above, the Fund (directly or indirectly through the
Subsidiary) intends to invest principally in exchange-traded commodity
futures contracts. Only in the event the Fund reaches the position
limits applicable to one or more exchange-traded commodity futures
contracts or a futures exchange imposes limitations on the Fund's
ability to maintain or increase its positions in an exchange-traded
commodity futures contract after reaching accountability levels or a
price limit is in effect on an exchange-traded commodity futures
contract during the last 30 minutes of its regular trading session, the
Fund's intention is to invest first in Cleared Swaps, to the extent
permitted under the position limits applicable to Cleared Swaps and
appropriate in light of the liquidity in the Cleared Swaps market, and
then, using its commercially reasonable judgment, in Other Commodity
Instruments (other than Cleared Swaps).
    (10) The Fund may hold up to an aggregate amount of 15% of its net
assets in illiquid assets (calculated at the time of investment),
deemed illiquid by the Adviser.
    (11) A minimum of 100,000 Shares will be outstanding at the
commencement of trading on the Exchange.
    The Commission notes that the Fund and the Shares must comply with
the initial and continued listing criteria in Nasdaq Rule 5735 for the
Shares to be listed and traded on the Exchange. In addition, the
Exchange represents that all statements and representations made in
this filing regarding (a) the description of the portfolio, (b)
limitations on portfolio holdings or reference assets, or (c) the
applicability of Exchange rules and surveillance procedures shall
constitute continued listing requirements for listing the Shares on the
Exchange. In addition, the issuer has represented to the Exchange that
it will advise the Exchange of any failure by the Fund to comply with
the continued listing requirements, and, pursuant to its obligations
under Section 19(g)(1) of the Act, the Exchange will monitor for
compliance with the

continued listing requirements.\34\ If the Fund is not in compliance
with the applicable listing requirements, the Exchange will commence
delisting procedures under the Nasdaq 5800 Series.\35\ This approval
order is based on all of the Exchange's representations, including
those set forth above and in the Notice, as modified by Amendment No. 1
to the proposed rule change.
---------------------------------------------------------------------------

    \34\ The Commission notes that certain other proposals for the
listing and trading of Managed Fund Shares include a representation
that the exchange will ``surveil'' for compliance with the continued
listing requirements. See, e.g., Securities Exchange Act Release No.
78005 (Jun. 7, 2016), 81 FR 38247 (Jun. 13, 2016) (SR-BATS-2015-
100). In the context of this representation, it is the Commission's
view that ``monitor'' and ``surveil'' both mean ongoing oversight of
a fund's compliance with the continued listing requirements.
Therefore, the Commission does not view ``monitor'' as a more or
less stringent obligation than ``surveil'' with respect to the
continued listing requirements.
    \35\ See id. at 42775.
---------------------------------------------------------------------------

    For the foregoing reasons, the Commission finds that the proposed
rule change, as modified by Amendment No. 1 thereto, is consistent with
Section 6(b)(5) of the Act \36\ and the rules and regulations
thereunder applicable to a national securities exchange.
---------------------------------------------------------------------------

    \36\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

IV. Conclusion

    It is Therefore Ordered, pursuant to Section 19(b)(2) of the
Exchange Act,\37\ that the proposed rule change (SR-NASDAQ-2016-086),
as modified by Amendment No. 1 thereto, be, and it hereby is, approved.
---------------------------------------------------------------------------

    \37\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\38\
---------------------------------------------------------------------------

    \38\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Robert W. Errett,
Deputy Secretary.
[FR Doc. 2016-19442 Filed 8-15-16; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: October 29, 2007 (Volume 72, Number 208)]
[Notices]
[Page 61128-61129]
[DOCID:fr29oc07-49]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

[FRL-8488-3; Docket ID No. EPA-HQ-ORD-2007-0920]

Board of Scientific Counselors, Human Health Risk Assessment
Subcommittee Meeting--November 14-16, 2007

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of meeting.

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

SUMMARY: Pursuant to the Federal Advisory Committee Act, Public Law 92-
463, the Environmental Protection Agency, Office of Research and
Development (ORD), gives notice of a meeting of the Board of Scientific
Counselors (BOSC) Human Health Risk Assessment Subcommittee.

DATES: The face-to-face meeting will be held on November 14-16, 2007.
The meeting will begin on November 14, 2007 (8:30 a.m. until 5 p.m.);
continue on November 15, 2007 (10 a.m. to 5 p.m.); and conclude on
November 16, 2007 (8:30 a.m. until 12 noon). All times noted are
eastern time. The meeting may adjourn early if all business is
finished. Requests for the draft agenda or for making oral
presentations at the meeting will be accepted up to 2 business days
before the meeting.

ADDRESSES: The meeting will be held at the Residence Inn by Marriott,
Bethesda Downtown, 7335 Wisconsin Avenue, Bethesda, Maryland 20814. The
hotel is located across the street from the Bethesda red line Metro
stop. Submit your comments, identified by Docket ID No. EPA-HQ-ORD-
2007-0920, by one of the following methods:
     http://www.regulations.gov: Follow the on-line instructions for

submitting comments.
     E-mail: Send comments by electronic mail (e-mail) to:
<EMAIL_ADDRESS>Attention Docket ID No. EPA-HQ-ORD-2007-0920.

     Fax: Fax comments to:<PHONE_NUMBER>, Attention Docket ID
No. EPA-HQ-ORD-2007-0920.
     Mail: Send comments by mail to: Board of Scientific
Counselors, Human Health Risk Assessment Subcommittee Meetings--Fall
2007 Docket, Mailcode: 2822T, 1200 Pennsylvania Ave., NW., Washington,
DC 20460, Attention Docket ID No. EPA-HQ-ORD-2007-0920.
     Hand Delivery or Courier. Deliver comments to: EPA Docket
Center (EPA/DC), Room 3334, EPA West Building, 1301 Constitution
Avenue, NW., Washington, DC, Attention Docket ID No. EPA-HQ-ORD-2007-
0920. Note: this is not a mailing address. Such deliveries are only
accepted during the docket's normal hours of operation, and special
arrangements should be made for deliveries of boxed information.
    Instructions: Direct your comments to Docket ID No. EPA-HQ-ORD-
2007-0920. EPA's policy is that all comments received will be included
in the public docket without change and may be made available online at
http://www.regulations.gov, including any personal information provided,

unless the comment includes information claimed to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Do not submit information that you consider to
be CBI or otherwise protected through http://www.regulations.gov or e-mail.

The http://www.regulations.gov Web site is an ``anonymous access'' system,

which means EPA will not know your identity or contact information
unless you provide it in the body of your comment. If you send an e-
mail comment directly to EPA without going through http://www.regulations.gov,

your e-mail address will be automatically captured and included as part
of the comment that is placed in the public docket and made available
on the Internet. If you submit an electronic comment, EPA recommends
that you include your name and other contact information in the body of
your comment and with any disk or CD-ROM you submit. If EPA cannot read
your comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses. For additional
information about EPA's public docket visit the EPA Docket Center
homepage at http://www.epa.gov/epahome/dockets.htm.

    Docket: All documents in the docket are listed in the
http://www.regulations.gov index. Although listed in the index, some

information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, will be publicly available only in hard copy.
Publicly available docket materials are available either electronically
in http://www.regulations.gov or in hard copy at the Board of Scientific

Counselors, Human Health Risk Assessment Subcommittee Meetings--Fall
2007 Docket, EPA/DC, EPA West, Room 3334, 1301 Constitution Ave., NW.,
Washington, DC. The 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 Public Reading Room is<PHONE_NUMBER>, and the telephone
number for the ORD Docket is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: The Designated Federal Officer via
express mail to: Joanna Foellmer, Charles Glover Building, 808 17\th\
Street, NW., 4\th\ Floor, Washington, DC 20006; via regular mail to:
Joanna Foellmer, Mail Code 8601D, Office of Research and Development,
U. S. Environmental Protection Agency, 1200 Pennsylvania Avenue, NW. ,
Washington, DC 20460; via phone/voice mail at:<PHONE_NUMBER>; via fax
at:<PHONE_NUMBER>; or via e-mail at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

General Information

    Any member of the public interested in receiving a draft BOSC
agenda or making a presentation at the meeting may contact Joanna
Foellmer, the Designated Federal Officer, via any of the contact
methods listed in the FOR FURTHER INFORMATION CONTACT section above. In
general, each individual making an oral presentation will be limited to
a total of three minutes.
    Proposed agenda items for the meeting include, but are not limited
to: how the human health risk assessment program is helping to
accomplish the mission of the U.S. EPA; and overviews and poster
sessions relevant to the Human Health Risk Assessment Program's long-
term goals: Goal 1; Integrated Risk Information System (IRIS) and other
priority health assessments; Goal 2; State of the Science, risk
assessment models, methods and guidance; and Goal 3; Integrated Science
Assessments, previously known as Air Quality Criteria Documents. The
meeting is open to the public. The subcommittee roster and charge can
be accessed at: http://www.epa.gov/osp/bosc/subcomm-hhra.htm.

    Information on Services for Individuals with Disabilities: For
information on access or services for individuals with disabilities,
please contact Joanna Foellmer on<PHONE_NUMBER> or
<EMAIL_ADDRESS>To request accommodation of a disability,

please contact Joanna Foellmer, preferably at least 10 days prior to
the

meeting, to give EPA as much time as possible to process your request.

    Dated: October 18, 2007.
Jeff Morris,
Acting Director, Office of Science Policy.
 [FR Doc. E7-21250 Filed 10-26-07; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register Volume 84, Number 98 (Tuesday, May 21, 2019)]
[Notices]
[Pages 23055-23056]
[FR Doc No: 2019-10537]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0801]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Exports: Notification
and Recordkeeping Requirements

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by June
20, 2019.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
Fax:<PHONE_NUMBER>, or emailed to<EMAIL_ADDRESS>All
comments should be identified with the OMB control number 0910-0482.
Also include the FDA docket number found in brackets in the heading of
this document.

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: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Exports: Notification and Recordkeeping Requirements--21 CFR 1.101

OMB Control Number 0910-0482--Extension

    Section 801 of the Federal Food, Drug, and Cosmetic Act (FD&C Act)
(21 U.S.C. 381) charges the Secretary of Health and Human Services,
through FDA, with the responsibility of helping to ensure that exports
of unapproved new drugs, biologics, devices, animal drugs, food,
cosmetics, and tobacco products which are not to be sold in the United
States

meet the requirements of the country to which the product is to be
exported. The respondents to this information collection are exporters
who have notified FDA of their intent to export unapproved products
that may not be sold or offered for sale in domestic commerce in the
United States as allowed under section 801(e) of the FD&C Act. In
general, the notification identifies the product being exported (e.g.,
name, description, and in some cases, country of destination) and
specifies where the notifications were sent. These notifications are
sent only for an initial export. Subsequent exports of the same product
to the same destination or to certain countries identified in section
802(b) of the FD&C Act (21 U.S.C. 382(b)) would not result in a
notification to FDA.
    The recordkeepers for this information collection are exporters of
products that may not be sold in the United States who are regulated by
the following FDA Centers: Center for Drug Evaluation and Research
(CDER); Center for Biologics Evaluation and Research (CBER); Center for
Devices and Radiological Health (CDRH); Center for Veterinary Medicine
(CVM); Center for Food Safety and Applied Nutrition (CFSAN); and Center
for Tobacco Products (CTP). Respondents to this collection of
information maintain records demonstrating their compliance with the
requirements in 21 CFR 1.101.
    In the Federal Register of February 15, 2019 (84 FR 4473), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of
                           21 CFR section                               Number of      responses per     Total annual    Average burden    Total hours
                                                                       respondents       respondent       responses       per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
1.101(d) (CBER)....................................................                5               92              460               15            6,900
1.101(d) (CDER)....................................................                5              180              900               15           13,500
1.101(d) (CDRH)....................................................              160                1              160               15            2,400
                                                                    ------------------------------------------------------------------------------------
    Total..........................................................  ...............  ...............  ...............  ...............           22,800
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

                                                   Table 2--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of                       Average burden
                           21 CFR section                               Number of       records per      Total annual         per          Total hours
                                                                      recordkeepers     recordkeeper       records       recordkeeping
--------------------------------------------------------------------------------------------------------------------------------------------------------
1.101 (b), (c), (e) (CBER, CDER, CDRH, CFSAN, and CVM).............              320                3              960               22           21,120
1.101(b) Office of International Programs only.....................                1              189              189               22            4,158
1.101(b) (currently regulated Tobacco Products)....................              322                3              966               22           21,252
                                                                    ------------------------------------------------------------------------------------
    Total..........................................................  ...............  ...............  ...............  ...............           46,530
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    We have adjusted our burden estimate, which has resulted in an
overall decrease of 129,543 hours to the currently approved burden. The
reporting burden estimate for CDRH has been adjusted to correct an
error and corresponding miscalculation in the previous burden estimate
and has been updated based on recent internal data. This adjustment
contributed to the overall burden estimate reduction by eliminating
8,030 responses and 120,450 hours from the reporting burden estimate.
CBER's estimated reporting burden for the information collection in
table 1 reflects a decrease of 7,575 hours and a corresponding decrease
of total annual responses (193 to 92). We attribute this adjustment to
a normal variation in the number of submissions we received over the
last few years. CTP's current number of respondents and recordkeeping
burden hours in table 2 are expected to decrease by 23 respondents and
1,518 hours. This is based on summary derived from the monthly
operational reports that manufacturers and importers of tobacco
products are required to file with the Alcohol and Tobacco Tax and
Trade Bureau.

    Dated: May 16, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-10537 Filed 5-20-19; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 83, Number 231 (Friday, November 30, 2018)]
[Notices]
[Pages 61711-61713]
[FR Doc No: 2018-26060]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[Docket No. NHTSA-2018-0014; Notice 1]

Notice of Receipt of Petition for Decision That Nonconforming
Model Year 2005 Chevrolet Corvette Passenger Cars Are Eligible for
Importation

AGENCY: National Highway Traffic Safety Administration (NHTSA),
Department of Transportation (DOT).

ACTION: Receipt of petition.

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

SUMMARY: This document announces receipt by the National Highway
Traffic Safety Administration (NHTSA) of a

petition for a decision that certain model year (MY) 2005 Chevrolet
Corvette passenger cars (PCs) that were not originally manufactured to
comply with all applicable Federal motor vehicle safety standards
(FMVSS) are eligible for importation into the United States because
they are substantially similar to vehicles that were originally
manufactured for sale in the United States and that were certified by
their manufacturer as complying with the safety standards (the U.S.-
certified version of the MY 2005 Chevrolet Corvette PCs) and are
capable of being readily altered to conform to the standards.

DATES: The closing date for comments on the petition is December 31,
2018.

ADDRESSES: Interested persons are invited to submit written data,
views, and arguments on this petition. Comments must refer to the
docket number cited in the title of this notice and must be submitted
by any of the following methods:
     Mail: Send comments by mail addressed to the 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: Deliver comments by hand to the U.S.
Department of Transportation, Docket Operations, M-30, West Building
Ground Floor, Room W12-140, 1200 New Jersey Avenue SE, Washington, DC
20590. The Docket Section is open on weekdays from 10 a.m. to 5 p.m.
except for Federal Holidays.
     Electronically: Submit comments electronically by logging
onto the Federal Docket Management System (FDMS) website at https://www.regulations.gov/. Follow the online instructions for submitting
comments.
     Comments may also be faxed to<PHONE_NUMBER>.
    Comments must be written in the English language, and be no greater
than 15 pages in length, although there is no limit to the length of
necessary attachments to the comments. If comments are submitted in
hard copy form, please ensure that two copies are provided. If you wish
to receive confirmation that comments you have submitted by mail were
received, please enclose a stamped, self-addressed postcard with the
comments. Note that all comments received will be posted without change
to https://www.regulations.gov, including any personal information
provided.
    All comments, background documentation, and supporting materials
submitted to the docket may be viewed by anyone at the address and
times given above. The documents may also be viewed on the internet at
https://www.regulations.gov by following the online instructions for
accessing the dockets. The docket ID number for this petition is shown
in the heading of this notice.
    DOT's complete Privacy Act Statement is available for review in a
Federal Register notice published on April 11, 2000, (65 FR 19477-78).

FOR FURTHER INFORMATION CONTACT: Neil Thurgood, Office of Vehicle
Safety Compliance, NHTSA, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. History

    Under 49 U.S.C. 30141(a)(1)(A), a motor vehicle that was not
originally manufactured to conform to all applicable FMVSS (49 CFR 571)
shall be refused admission into the United States unless NHTSA has
decided that the motor vehicle is substantially similar to a motor
vehicle originally manufactured for importation into and sale in the
United States, certified under 49 U.S.C. 30115, and of the same model
year as the model of the motor vehicle to be compared, and is capable
of being readily altered to conform to all applicable FMVSS.
    Petitions for eligibility decisions may be submitted by either
manufacturers or importers who have registered with NHTSA pursuant to
49 CFR part 592. As specified in 49 CFR 593.7, Processing of Petitions,
NHTSA publishes notice in the Federal Register of each petition that it
receives, and affords interested persons an opportunity to comment on
the petition. At the close of the comment period, NHTSA decides, on the
basis of the petition and any comments that it has received, whether
the vehicle is eligible for importation. The agency then publishes this
decision in the Federal Register.

II. Summary of Petition

    Wallace Environmental Testing Laboratories (WETL), of Houston,
Texas (Registered Importer R-90-005) has petitioned NHTSA to decide
whether nonconforming MY 2005 Chevrolet Corvette PCs are eligible for
importation into the United States. The vehicles that WETL believes are
substantially similar are MY 2005 Chevrolet Corvette PCs, manufactured
for sale in the United States and certified by their manufacturer as
conforming to all applicable FMVSS.
    The petitioner submitted information with its petition intended to
demonstrate that the subject non-U.S.-certified vehicles as originally
manufactured, conform to many applicable FMVSS in the same manner as
their U.S.-certified counterparts, or are capable of being readily
altered to conform to those standards.
    Specifically, the petitioner claims that the non-U.S.-certified MY
2005 Chevrolet Corvette PCs, as originally manufactured, conforms to:
Standard Nos. 102 Transmission Shift Position Sequence, Starter
Interlock, and Transmission Braking Effect, 103 Windshield Defrosting
and Defogging Systems, 104 Windshield Wiping and Washing Systems, 106
Brake Hoses, 108 Lamps, Reflective Devices and Associated Equipment,
110 Tire Selection and Rims and Motor Home/Recreation Vehicle Trailer
Load Carrying Capacity Information for Motor Vehicles with a GVWR of
4,536 Kilograms (10,000 Pounds) or Less, 111 Rearview Mirrors, 113 Hood
Latch System, 114 Theft Protection, 116 Motor Vehicle Brake Fluids, 118
Power-Operated Window, Partition, and Roof Panel Systems, 124
Accelerator Control Systems, 135 Light Vehicle Brake Systems, 138 Tire
Pressure Monitoring Systems, 201 Occupant Protection in Interior
Impact, 202a Head Restraints; Mandatory Applicability Begins on
September 1, 2008, 204 Steering Control Rearward Displacement, 205
Glazing Materials, 206 Door Locks and Door Retention Components, 207
Seating Systems, 209 Seat Belt Assemblies, 210 Seat Belt Assembly
Anchorages, 212 Windshield Mounting, 214 Side Impact Protection, 216
Roof Crush Resistance, 219 Windshield Zone Intrusion, 225 Child
Restraint Anchorage Systems, 301 Fuel System Integrity, 302
Flammability of Interior Materials and 401 Interior Trunk Release.
    The petitioner also contends that the subject non-U.S.-certified
passenger cars are capable of being readily altered to meet the
following standards in the manners indicated:
    Standard No. 101 Controls and Displays: The brake warning telltale
must be modified to show the word ``BRAKE'' when activated.
    Standard No. 208 Occupant Crash Protection: Inspection to ascertain
if the software and firmware installed in the vehicle are the same as
the most up-to-date versions installed in the U.S.-conforming version
of the vehicle. Replacement of any software or firmware found not to be
the most recent versions. Replacement of sun visors with U.S.-model
components to meet the labeling requirements of FMVSS No. 208.
    The petitioner additionally states that a vehicle identification
plate must be

affixed to the vehicle near the left windshield pillar to meet the
requirements of 49 CFR part 565.

III. Comments

    All comments and supporting materials received before the close of
business on the closing date indicated above will be filed in the
docket and considered. Comments filed after the closing date will also
be considered to the fullest extent possible and available for
examination in the docket at the above addresses.
    Once the petition is granted or denied, notice of the decision will
be published in the Federal Register pursuant to the authority
indicated at the end of this notice.
    This notice of receipt of the subject petition does not represent
any agency decision or other exercise of judgment concerning the merits
of the petition. Notice of final action on the petition will be
published in the Federal Register pursuant to the authority indicated
below.

    Authority: 49 U.S.C. 30141(a)(1)(A), (a)(1)(B), and (b)(1); 49
CFR 593.7; delegation of authority at 49 CFR 1.95 and 501.8.

Michael A. Cole,
Acting Director, Office of Vehicle Safety Compliance.
[FR Doc. 2018-26060 Filed 11-29-18; 8:45 am]
 BILLING CODE 4910-59-P


[Federal Register Volume 84, Number 169 (Friday, August 30, 2019)]
[Proposed Rules]
[Pages 45700-45702]
[FR Doc No: 2019-18240]

=======================================================================
-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 62

[EPA-HQ-OAR-2019-0298; FRL-9998-65-OAR]
RIN 2060-AU49

General Provisions Amendments: Incorporation by Reference of
State Plans

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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

SUMMARY: The U.S. Environmental Protection Agency is proposing to amend
the Approval and Promulgation of State Plans for Designated Facilities
and Pollutants, General Provisions to clarify the process by which
state plans for the control of pollutants and facilities are
incorporated by reference into this part. This action is intended to
update and modify the outdated General Provisions that note that state
plans are incorporated by reference and that describe the availability
of state plans. Concurrently, EPA is also taking direct final action on
these amendments. If we receive no significant adverse comment, we will
not take further action on this proposed rule.

DATES:
    Comments. Comments must be received on or before October 15, 2019,
or 30 days after date of public hearing, if one is requested.
    Public hearing. If anyone contacts us requesting a public hearing
on or before September 4, 2019, we will hold a hearing. Additional
information about the hearing, if requested, will be published in a
subsequent Federal Register document and posted at https://www.epa.gov/stationary-sources-air-pollution/amendments-general-provisions-part-62-incorporation-reference-clean. See SUPPLEMENTARY INFORMATION for
information on registering and attending a public hearing.

ADDRESSES: You may send comments, identified by Docket ID No. EPA-HQ-
OAR-2019-0298, by any of the following methods:
     Federal eRulemaking Portal: https://www.regulations.gov/
(our preferred method). Follow the online instructions for submitting
comments.

     Email<EMAIL_ADDRESS>Include Docket ID No. EPA-
HQ-OAR-2019-0298 in the subject line of the message.
     Fax:<PHONE_NUMBER>. Attention Docket ID No. EPA-HQ-OAR-
2019-0298.
     Mail: U.S. Environmental Protection Agency, EPA Docket
Center, Docket ID No. EPA-HQ-OAR-2019-0298, Mail Code 28221T, 1200
Pennsylvania Avenue NW, Washington, DC 20460.
     Hand/Courier Delivery: EPA Docket Center, WJC West
Building, Room 3334, 1301 Constitution Avenue NW, Washington, DC 20004.
The Docket Center's hours of operation are 8:30 a.m.-4:30 p.m., Monday-
Friday (except federal holidays).
    Instructions: All submissions received must include the Docket ID
No. for this rulemaking. Comments received may be posted without change
to https://www.regulations.gov/, including any personal information
provided. For detailed instructions on sending comments and additional
information on the rulemaking process, see the SUPPLEMENTARY
INFORMATION section of this document.

FOR FURTHER INFORMATION CONTACT: For questions about this proposed
action, contact Jodi Howard, Sector Policies and Programs Division
(D205-02), Office of Air Quality Planning and Standards, U.S.
Environmental Protection Agency, Research Triangle Park, North Carolina
27711; telephone number:<PHONE_NUMBER>; fax number:<PHONE_NUMBER>;
and email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Public hearing. Please contact Nancy Perry
at<PHONE_NUMBER> or at<EMAIL_ADDRESS>to request a hearing, to
determine if a hearing will be held, or to register to speak at the
hearing, if one is held.
    Docket. The EPA has established a docket for this rulemaking under
Docket ID No. EPA-HQ-OAR-2019-0298. All documents in the docket are
listed in Regulations.gov. Although listed, some information is not
publicly available, e.g., Confidential Business Information (CBI) or
other information whose disclosure is restricted by statute. Certain
other material, such as copyrighted material, is not placed on the
internet and will be publicly available only in hard copy. Publicly
available docket materials are available either electronically in
Regulations.gov or in hard copy at the EPA Docket Center, Room 3334,
WJC West Building, 1301 Constitution Avenue NW, Washington, DC. The
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 Public
Reading Room is<PHONE_NUMBER>, and the telephone number for the EPA
Docket Center is<PHONE_NUMBER>.
    Instructions. Direct your comments to Docket ID No. EPA-HQ-OAR-
2019-0298. The EPA's policy is that all comments received will be
included in the public docket without change and may be made available
online at https://www.regulations.gov/, including any personal
information provided, unless the comment includes information claimed
to be CBI or other information whose disclosure is restricted by
statute. Do not submit information that you consider to be CBI or
otherwise protected through https://www.regulations.gov/ or email. This
type of information should be submitted by mail as discussed below.
    The EPA may publish any comment received to its public docket.
Multimedia submissions (audio, video, etc.) must be accompanied by a
written comment. The written comment is considered the official comment
and should include discussion of all points you wish to make. The EPA
will generally not consider comments or comment contents located
outside of the primary submission (i.e., on the Web, cloud, or other
file sharing system). For additional submission methods, the full EPA
public comment policy, information about CBI or multimedia submissions,
and general guidance on making effective comments, please visit https://www.epa.gov/dockets/commenting-epa-dockets.
    The https://www.regulations.gov/ website allows you to submit your
comment anonymously, which means the EPA will not know your identity or
contact information unless you provide it in the body of your comment.
If you send an email comment directly to the EPA without going through
https://www.regulations.gov/, your email address will be automatically
captured and included as part of the comment that is placed in the
public docket and made available on the internet. If you submit an
electronic comment, the EPA recommends that you include your name and
other contact information in the body of your comment and with any
digital storage media you submit. If the EPA cannot read your comment
due to technical difficulties and cannot contact you for clarification,
the EPA may not be able to consider your comment. Electronic files
should not include special characters or any form of encryption and be
free of any defects or viruses. For additional information about the
EPA's public docket, visit the EPA Docket Center homepage at https://www.epa.gov/dockets.
    Submitting CBI. Do not submit information containing CBI to the EPA
through https://www.regulations.gov/ or email. Clearly mark the part or
all of the information that you claim to be CBI. For CBI information on
any digital storage media that you mail to the EPA, mark the outside of
the digital storage media as CBI and then identify electronically
within the digital storage media the specific information that is
claimed as CBI. In addition to one complete version of the comments
that includes information claimed as CBI, you must submit a copy of the
comments that does not contain the information claimed as CBI directly
to the public docket through the procedures outlined in Instructions
above. If you submit any digital storage media that does not contain
CBI, mark the outside of the digital storage media clearly that it does
not contain CBI. Information not marked as CBI will be included in the
public docket and the EPA's electronic public docket without prior
notice. Information marked as CBI will not be disclosed except in
accordance with procedures set forth in 40 Code of Federal Regulations
(CFR) part 2. Send or deliver information identified as CBI only to the
following address: OAQPS Document Control Officer (C404-02), OAQPS,
U.S. Environmental Protection Agency, Research Triangle Park, North
Carolina 27711, Attention Docket ID No. EPA-HQ-OAR-2019-0298.

I. Why is the EPA issuing this proposed rule?

    The EPA is issuing both a proposal and a direct final rule amending
Sec. Sec.  62.02, 62.10, and 62.12 of subpart A of 40 CFR part 62. As
further discussed in the direct final rule action, these amendments
update and clarify provisions relating to the Incorporation by
Reference (IBR) of state plans approved, in accordance with Clean Air
Act sections 111(d) and 129, by the EPA, including information
concerning the availability of such plans.
    The EPA is taking direct final action because we view the revisions
as administrative, noncontroversial, and anticipate no significant
adverse comments. The EPA has identified the specific revisions and
explained our reasons for these revisions in the direct final rule. At
the same time, the EPA is proposing to make the same amendments. If no
significant adverse comments are received, no further action will be
taken on the proposal,

and the direct final rule will become effective as provided in that
action.
    If the EPA receives significant adverse comments, we will withdraw
the direct final rule. The EPA will publish a timely withdrawal in the
Federal Register. If the direct final rule in the Rules and Regulations
section of this Federal Register is withdrawn, all comments will be
addressed in a subsequent final rule based on this proposal. The EPA
will not institute a second comment period pertaining to the revisions
on the subsequent final action. Any parties interested in commenting
should do so at this time.
    The amendments to the regulatory text proposed in this notice are
identical to the amendments made in the direct final rule published in
the Rules and Regulations section of this Federal Register. For further
supplementary information and the rationale for the proposal and the
regulatory revisions, see the direct final rule published in the Rules
and Regulations section of this Federal Register.

II. Statutory and Executive Order Reviews

    For a complete discussion of the administrative requirements
applicable to this action, see the direct final rule in the Rules and
Regulations section of this Federal Register.

    Dated: August 15, 2019.
Andrew R. Wheeler,
Administrator.
[FR Doc. 2019-18240 Filed 8-29-19; 8:45 am]
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[Federal Register Volume 79, Number 51 (Monday, March 17, 2014)]
[Rules and Regulations]
[Pages 14609-14611]
[FR Doc No: 2014-05430]

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

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

The Code of Federal Regulations is sold by the Superintendent of Documents.
Prices of new books are listed in the first FEDERAL REGISTER issue of each
week.

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

Federal Register / Vol. 79, No. 51 / Monday, March 17, 2014 / Rules
and Regulations

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 514

[Docket No. FDA-2014-N-0108]

New Animal Drug Applications; Confidentiality of Data and
Information in a New Animal Drug Application File

AGENCY: Food and Drug Administration, HHS.

ACTION: Direct final rule.

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

SUMMARY: The Food and Drug Administration (FDA) is amending its
regulation regarding the confidentiality of data and information in and
about new animal drug application files to change when certain
approval-related information will be disclosed by the Agency. This
change will ensure that the Agency is able to update its list of
approved new animal drug products within the statutory timeframe. It
will also permit more timely public disclosure of approval-related
information, increasing the transparency of FDA decision making in the
approval of new animal drugs.

DATES: This rule is effective July 30, 2014. Submit either electronic
or written comments by June 2, 2014. If FDA receives no significant
adverse comments within the specified comment period, the Agency will
publish a document confirming the effective date of the final rule in
the Federal Register within 30 days after the comment period on this
direct final rule ends. If timely significant adverse comments are
received, the Agency will publish a document in the Federal Register
withdrawing this direct final rule before its effective date.

ADDRESSES: You may submit comments, identified by Docket No. FDA-2014-
N-0108, by any of the following methods:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.

Written Submissions

    Submit written submissions in the following ways:
     Mail/ Hand Delivery/ Courier (for paper submissions):
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the Agency name
and Docket No. FDA-2014-N-0108 for this rulemaking. All comments
received may be posted without change to http://www.regulations.gov,
including any personal information provided. For additional information
on submitting comments, see the ``Comments'' heading of the
SUPPLEMENTARY INFORMATION section of this document.
    Docket: For access to the docket to read background documents or
comments received, go to http://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 Division of
Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Scott Fontana, Center for Veterinary
Medicine (HFV-100), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 512(i) (21 U.S.C. 360b(i)) was added to the Federal Food,
Drug, and Cosmetic Act (the FD&C Act) by the Animal Drug Amendments of
1968 (Pub. L. 90-399). Section 512(i) requires the conditions and
indications of use of a new animal drug to be published in the Federal
Register upon approval of a new animal drug application (NADA) filed
under section 512(b) of the FD&C Act.
    In 1974, FDA revised its regulations regarding the confidentiality
of information in applications in Sec.  135.33a (21 CFR 135.33a) to
include provisions of the Freedom of Information Act (Pub. L. 89-487).
That revision established that public disclosure by the Agency of
certain data and information in an NADA file could not occur before the
Federal Register notice of approval published (39 FR 44653, December
24, 1974). Shortly thereafter, Sec.  135.33a was redesignated as Sec.
514.11 (21 CFR 514.11) (40 FR 13802 at 13825, March 27, 1975).
    In 1988, the Generic Animal Drug and Patent Term Restoration Act
(Pub. L. 100-670) added section 512(n)(4)(A) of the FD&C Act, which
states that the Agency shall publish a list of approved new animal drug
products and revise that list every 30 days to include each new animal
drug that has been approved during that 30-day period. This list, as
well as related patent information and marketing exclusivity periods,
is contained in a document generally known as the ``Green Book,''
available at the Agency's public Web site at http://www.fda.gov/AnimalVeterinary/Products/ApprovedAnimalDrugProducts ApprovedAnimalDrugProducts.
    The editorial and clearance processes for publishing the Federal
Register notice announcing the approval of an NADA varies from 1 to 2
months after the approval letter is issued to the applicant.
Consequently, the addition of newly approved product information to the
``Green Book'' and public disclosure of certain other approval-related
information at the Agency's public Web site is delayed until after that
Federal Register notice is published. Such other approval-related
information may include the summary of information forming the basis
for approval (known also as the Freedom of Information Summary) and
documentation of environmental review. Trade and proprietary
information in the application file remains confidential and is not
disclosed.
    FDA is issuing this direct final rule amending Sec.  514.11 to
change the time when certain approval-related information in an NADA
file will be publicly disclosed, from when notice of the approval is
published in the Federal Register to when the application is approved.
This change will ensure that the Agency is able to update the ``Green
Book'' within the 30-day statutory timeframe (see section
512(n)(4)(A)(ii) of the FD&C Act). It will also permit more timely
public disclosure of certain approval-related information following
sponsor notification of application approval, increasing the
transparency of

Agency decision making in the approval of new animal drugs.

II. Direct Final Rulemaking

    FDA has determined that the subject of this rulemaking is suitable
for a direct final rule. FDA is amending Sec.  514.11 to change the
time when certain approval-related information in an NADA file will be
publicly disclosed to ensure that the Agency is able to update the
``Green Book'' within the 30-day statutory timeframe. This rule is
intended to make noncontroversial changes to existing regulations. The
Agency does not anticipate receiving any significant adverse comment on
this rule.
    Consistent with FDA's procedures on direct final rulemaking, we are
publishing elsewhere in this issue of the Federal Register a companion
proposed rule. The companion proposed rule and this direct final rule
are substantively identical. The companion proposed rule provides the
procedural framework within which the rule may be finalized in the
event the direct final rule is withdrawn because of any significant
adverse comment. The comment period for this direct final rule runs
concurrently with the comment period of the companion proposed rule.
Any comments received in response to the companion proposed rule will
also be considered as comments regarding this direct final rule.
    FDA is providing a comment period for the direct final rule of 75
days after the date of publication in the Federal Register. If FDA
receives any significant adverse comment, we intend to withdraw this
direct final rule before its effective date by publication of a notice
in the Federal Register within 30 days after the comment period ends. A
significant adverse comment is one that explains why the rule would be
inappropriate, including challenges to the rule's underlying premise or
approach, or would be ineffective or unacceptable without a change. In
determining whether an adverse comment is significant and warrants
withdrawing a direct final rule, the Agency will consider whether the
comment raises an issue serious enough to warrant a substantive
response in a notice-and-comment process in accordance with section 553
of the Administrative Procedure Act (5 U.S.C. 553).
    Comments that are frivolous, insubstantial, or outside the scope of
the direct final rule will not be considered significant or adverse
under this procedure. For example, a comment recommending a regulation
change in addition to those in the rule would not be considered a
significant adverse comment unless the comment states why the rule
would be ineffective without the additional change. In addition, if a
significant adverse comment applies to an amendment, paragraph, or
section of this rule and that provision can be severed from the
remainder of the rule, FDA may adopt as final those provisions of the
rule that are not the subject of a significant adverse comment.
    If FDA does not receive significant adverse comment in response to
the direct final rule, the Agency will publish a document in the
Federal Register confirming the effective date of the final rule. The
Agency intends to make the direct final rule effective 30 days after
publication of the confirmation document in the Federal Register.
    A full description of FDA's policy on direct final rule procedures
may be found in a guidance document published in the Federal Register
of November 21, 1997 (62 FR 62466). The guidance document may be
accessed at: http://www.fda.gov/RegulatoryInformation/Guidances/ucm125166.htm.

III. Legal Authority

    FDA is issuing this direct final rule under section 512(c) of the
FD&C Act. This section gives the Secretary of Health and Human Services
the authority to approve new animal drug applications. In addition,
section 701(a) of the FD&C Act (21 U.S.C. 371(a)) gives FDA general
rulemaking authority to issue regulations for the efficient enforcement
of the FD&C Act.

IV. Environmental Impact

    FDA has determined under 21 CFR 25.30(h) that this action is of a
type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.

V. Analysis of Impacts

    FDA has examined the impacts of this direct final rule under
Executive Order 12866, Executive Order 13563, the Regulatory
Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform
Act of 1995 (Pub. L. 104-4). Executive Orders 12866 and 13563 direct
Agencies to assess all costs and benefits of available regulatory
alternatives and, when regulation is necessary, to select regulatory
approaches that maximize net benefits (including potential economic,
environmental, public health and safety, and other advantages;
distributive impacts; and equity). The Agency believes that this direct
final rule is not a significant regulatory action as defined by
Executive Order 12866.
    The Regulatory Flexibility Act requires Agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. Because this direct final rule would not impose any
compliance costs on the sponsors of animal drug products that are
currently marketed or in development, the Agency certifies that this
direct final rule will not have a significant economic impact on a
substantial number of small entities.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires
that Agencies prepare a written statement, which includes an assessment
of anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $141 million, using the most current (2012) Implicit
Price Deflator for the Gross Domestic Product. FDA does not expect this
direct final rule to result in any 1-year expenditure that would meet
or exceed this amount.

VI. Federalism

    FDA has analyzed this direct final rule in accordance with the
principles set forth in Executive Order 13132. FDA has determined that
the direct final rule does not contain policies that have substantial
direct effects 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. Accordingly,
the Agency concludes that the direct final rule does not contain
policies that have federalism implications as defined in the Executive
Order and, consequently, a federalism summary impact statement is not
required.

VII. Paperwork Reduction Act of 1995

    This direct final rule contains no collection of information.
Therefore, clearance by the Office of Management and Budget under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520) is not required.

VIII. Comments

    Interested persons may submit either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). 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.

List of Subjects in 21 CFR Part 514

    Administrative practice and procedure, Animal drugs, Confidential
business information, Reporting and recordkeeping requirements.

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

PART 514--NEW ANIMAL DRUG APPLICATIONS

0
1. The authority citation for 21 CFR part 514 continues to read as
follows:

    Authority: 21 U.S.C. 321, 331, 351, 352, 356a, 360b, 371, 379e,
381.

0
2. In Sec.  514.11, revise paragraphs (b), (d), (e) introductory text,
and (e)(2)(ii) introductory text to read as follows:

Sec.  514.11  Confidentiality of data and information in a new animal
drug application file.

* * * * *
    (b) The existence of an NADA file will not be disclosed by the Food
and Drug Administration before the application has been approved,
unless it has been previously disclosed or acknowledged.
* * * * *
    (d) If the existence of an NADA file has been publicly disclosed or
acknowledged before the application has been approved, no data or
information contained in the file is available for public disclosure,
but the Commissioner may, in his discretion, disclose a summary of such
selected portions of the safety and effectiveness data as are
appropriate for public consideration of a specific pending issue, i.e.,
at an open session of a Food and Drug Administration advisory committee
or pursuant to an exchange of important regulatory information with a
foreign government.
    (e) After an application has been approved, the following data and
information in the NADA file are immediately available for public
disclosure unless extraordinary circumstances are shown:
* * * * *
    (2) * * *
    (ii) For an NADA approved after July 1, 1975, a summary of such
data and information prepared in one of the following two alternative
ways shall be publicly released when the application is approved.
* * * * *

    Dated: March 7, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-05430 Filed 3-14-14; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 77, Number 177 (Wednesday, September 12, 2012)]
[Notices]
[Pages 56201-56202]
[FR Doc No: 2012-22404]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OAR-2003-0162; FRL 9521-6]

Information Collection Request Submitted to OMB for Review and
Approval; Comment Request; Regional Haze Regulations (Renewal)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: The Environmental Protection Agency has submitted an
information collection request (ICR), ``Regional Haze Regulations''
(EPA ICR No. 1813.08, OMB Control No. 2060-0421), to the Office of
Management and Budget (OMB) for review and approval in accordance with
the Paperwork Reduction Act (44 U.S.C. 3501 et seq.). This is a
proposed extension of the ICR, which is currently approved through
October 31, 2012. Public comments were previously requested via the
Federal Register (77 FR 24952) on April 26, 2012, during a 60-day
comment period. This notice allows for an additional 30 days for public
comments. A fuller description of the ICR is given below, including its
estimated burden and cost to the public. 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.

DATES: Additional comments may be submitted on or before October 12,
2012.

ADDRESSES: Submit your comments, referencing Docket ID No. EPA-HQ-OAR-
2003-0162, to (1) EPA online using www.regulations.gov (our preferred
method), by email to<EMAIL_ADDRESS>or by mail to: EPA
Docket Center, Environmental Protection Agency, Mail Code 28221T, 1200
Pennsylvania Avenue NW., Washington, DC 20460, and (2) OMB via email to
<EMAIL_ADDRESS>Address comments to OMB Desk Officer for
EPA.
    The EPA's policy is that all comments received will be included in
the public docket without change including any personal information
provided, unless the comment includes profanity, threats, information
claimed to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute.

FOR FURTHER INFORMATION CONTACT: Ms. Gobeail McKinley<PHONE_NUMBER>,
<EMAIL_ADDRESS>Office of Air Quality Planning and Standards,
Air Quality Policy Division, Mail Code C539-04, Research Triangle Park,
NC 27711.

SUPPLEMENTARY INFORMATION: Supporting documents, which explain in
detail the information that the EPA will be collecting, are available
in the public docket for this ICR. The docket can be viewed online at
www.regulations.gov or in person at the EPA Docket Center, EPA West,
Room 3334, 1301 Constitution Avenue NW., Washington, DC The telephone
number for the Docket Center is<PHONE_NUMBER>. For additional
information about EPA's public docket, visit http://www.epa.gov/dockets.
    Abstract: This ICR is for activities related to the implementation
of the EPA's 1999 regional haze rule, for the time period between
October 31, 2012 and October 30, 2015, and renews the previous ICR. The
regional haze rule, as authorized by sections 169A and 169B of the
Clean Air Act (CAA), requires states to develop implementation plans to
protect visibility in 156 federally-protected Class I areas. Tribes may
choose to develop implementation plans. For this time period, states
will be completing their implementation plans to comply with the rule.
Before any agency, department, or instrumentality of the federal
government engages in, supports in any way, provides financial
assistance for, licenses, permits, or approves any activity, that
agency has the affirmative responsibility to ensure that such action
conforms to the State Implementation Plan (SIP) required under the
regional haze rule. Section 176(c) of the CAA requires that all Federal
actions conform with the SIP requirements. Depending on the type of
action, the federal entities must collect information themselves, hire
consultants to collect the

information or require applicants/sponsors of the federal action to
provide the information.
    Respondents/affected entities: Entities potentially affected by
this action are state, local, and tribal air quality agencies, regional
planning organizations and facilities potentially regulated under the
regional haze rule.
    Respondents/affected entities: States and Federal Land Managers.
    Respondent's obligation to respond: Mandatory.
    Estimated number of respondents: 53.
    Frequency of response: Annual.
    Total estimated burden: 6,048 hours.
    Total estimated cost: $293,631. This includes an estimated labor
cost of $293,631 and an estimated cost of $0 for capital investment or
maintenance and operational costs.
    Changes in the Estimates: There is a decrease of 25,793 hours in
the total estimated burden currently identified in the OMB Inventory of
Approved ICR Burdens. The last collection request anticipated the
program progressing from the planning stages to implementation. The
change in burden reflects changes in labor rates, changes in the
activities conducted due to the normal progression of the program, and
the fact that the aggregate initial regional haze SIPs and best
available retrofit technology (BART) determinations will be acted on by
the EPA by November 2012 and the states will be evaluating reasonable
progress and implementation stages for the goals in those SIPs.

John Moses,
Director, Collection Strategies Division.
[FR Doc. 2012-22404 Filed 9-11-12; 8:45 am]
BILLING CODE 6560-50-P