[Federal Register Volume 81, Number 133 (Tuesday, July 12, 2016)]
[Notices]
[Pages 45185-45188]
[FR Doc No: 2016-16380]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-78236; File No. SR-BatsBZX-2016-26]

Self-Regulatory Organizations; Bats BZX Exchange, Inc.; Notice of
Filing of Proposed Rule Change to BZX Rule 14.11(d) To Add the EURO
STOXX 50[supreg] Volatility Futures to the Definition of Futures
Reference Asset

July 6, 2016.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on June 23, 2016, Bats BZX Exchange, Inc. (the ``Exchange'' or
``BZX'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I and
II below, which Items have been prepared by the Exchange. The
Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of the
Substance of the Proposed Rule Change

    The Exchange filed a proposal to amend Rule 14.11(d) in order to
add the EURO STOXX 50[supreg] Volatility (VSTOXX[supreg]) Futures
(``VSTOXX Futures'') to the definition of Futures Reference Asset.
    The text of the proposed rule change is available at the Exchange's
Web site at www.batstrading.com, at the principal office of the
Exchange, and at the Commission's Public Reference Room.

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

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

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

1. Purpose
    The Commission has approved the listing of debt securities known as
Linked Securities \3\ and, in particular, Futures-Linked Securities,
which are Linked Securities with a payment at maturity based on the
performance of a Futures Reference Asset,\4\ including listing pursuant
to Rule 19b-4(e) under Rule 14.11(d)(2).\5\ Rule 19b-4(e) \6\ under the
Act provides that the listing and trading of a new derivative
securities product by a self-regulatory organization (``SRO'') shall
not be deemed a proposed rule change, pursuant to section (c)(1) of
Rule 19b-4,\7\ if the Commission has

approved, pursuant to Section 19(b) of the Act,\8\ the SRO's trading
rules, procedures, and listing standards for the product class and the
SRO has a surveillance program for the product class.\9\
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    \3\ As defined in Rule 14.11(d), ``Linked Securities'' includes
Multifactor Index-Linked Securities, Equity Index-Linked Securities,
Commodity-Linked Securities, Fixed Income Index-Linked Securities,
and Futures-Linked Securities.
    \4\ As defined in Rule 14.11(d), ``Futures Reference Asset''
includes ``an index of (a) futures on Treasury Securities, GSE
Securities, supranational debt and debt of a foreign country or a
subdivision thereof, or options or other derivatives on any of the
foregoing; or (b) interest rate futures or options or derivatives on
the foregoing in this subparagraph (b); or (c) CBOE Volatility Index
(VIX) Futures.''
    \5\ See Securities Exchange Act Release No. 65225 (August 30,
2011), 76 FR 55148 (September 6, 2011) (SR-BATS-2011-018) (Order
Approving Proposed Rule Change to Adopt Rules for the Qualification,
Listing and Delisting of Companies on the Exchange) (the ``Approval
Order''). The Approval Order approved the rules permitting the
listing of both Tier I and Tier II securities on the Exchange and
the requirements associated therewith, which includes, among others,
the listing and trading of Linked Securities, trading hours and
halts, and listing fees originally applicable to Linked Securities.
    \6\ 17 CFR 240.19b-4(e).
    \7\ 17 CFR 240.19b-4(c)(1).
    \8\ 15 U.S.C. 78s(b).
    \9\ See Securities Exchange Act Release No. 40761 (December 8,
1998), 63 FR 70952 (December 22, 1998).
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    The Exchange proposes to amend Rule 14.11(d) in order to add VSTOXX
Futures to the definition of Futures Reference Asset, which would allow
the Exchange to list Futures-Linked Securities linked to VSTOXX Futures
through generic listing standards pursuant to Rule 19b-4(e) under BZX
Rule 14.11(d)(2)(K)(iv).
    Rule 14.11(d)(2)(K)(iv)(a) requires that a Futures-Linked Security
meet one of the following standards: (1) That the Futures Reference
Asset to which the security is linked shall have been reviewed and
approved for the trading of Futures-Linked Securities or options or
other derivatives by the Commission under Section 19(b)(2) of the Act
and rules thereunder and the conditions set forth in the Commission's
approval order, including with respect to comprehensive surveillance
sharing agreements, continue to be satisfied; or (2) the pricing
information for components of a Futures Reference Asset must be derived
from a market which is a member or affiliate of a member of the
Intermarket Surveillance Group (``ISG'') or a market with which the
Exchange has a comprehensive surveillance sharing agreement
(``CSSA'').\10\ A Futures Reference Asset may include components not
representing more than 10% of the dollar weight of such Futures
Reference Asset for which the pricing information is derived from
markets that do not meet requirement (2); provided, however, that no
single component subject to this exceptions [sic] exceeds 7% of the
dollar weight of the Futures Reference Asset. As proposed, adding
VSTOXX Futures to the definition of Futures Reference Asset would
satisfy the first criterion described above and the second criterion
would be satisfied by virtue of Eurex Deutschland's membership in ISG,
as further described below.
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    \10\ ISG is comprised of an international group of exchanges,
market centers, and market regulators that perform front-line market
surveillance in their respective jurisdictions. See https://www.isgportal.org/home.html.
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    Further, any Futures-Linked Securities linked to VSTOXX Futures
would also be required to meet both the initial and continued listing
standards under Rule 14.11(d)(2)(K)(iv)(b) and (c) or be subject to
delisting or removal proceedings, which include: (i) That the value of
the Futures Reference Asset be calculated and widely disseminated by
one or more major market data vendors on at least a 15-second basis
during the Exchange's regular market session; (ii) for Futures-Linked
Securities that are periodically redeemable, the Intraday Indicative
Value of the securities must be calculated and widely disseminated by
the Exchange or one or more major market data vendors on at least a 15-
second basis during the Exchange's regular market session; (iii) the
aggregate market value or the principal amount of the Futures-Linked
Securities must be at least $400,000; (iv) the value of the VSTOXX
Futures must be calculated and available; and (v) any other event
occurs or condition exists which in the opinion of the Exchange makes
further dealings on the Exchange inadvisable. Any Futures-Linked
Securities linked to VSTOXX Futures would also be required to meet the
listing standards applicable to all Linked Securities under
14.11(d)(2). Finally, all Linked Securities listed pursuant to Rule
14.11(d) are included within the definition of ``security'' or
``securities'' as such terms are used in the Rules of the Exchange and,
as such, are subject to the full panoply of Exchange Rules and
procedures that currently govern the trading of securities on the
Exchange.
    The Exchange believes that the proposed standards would continue to
ensure transparency surrounding the listing process for Linked
Securities. Additionally, the Exchange believes that the existing
standards for listing and trading Futures-Linked Securities are
reasonably designed to promote a fair and orderly market for such
Futures-Linked Securities and the addition of VSTOXX Futures to Futures
Reference Assets does not affect this. The proposed addition of VSTOXX
Futures to those instruments included in Futures Reference Assets would
also work in conjunction with the existing initial and continued
listing criteria related to surveillance procedures and trading
guidelines.
    The Exchange believes that its surveillance procedures are adequate
to continue to properly monitor the trading of the Futures-Linked
Securities linked to VSTOXX Futures in all trading sessions and to
deter and detect violations of Exchange rules. Specifically, the
Exchange intends to utilize its existing surveillance procedures
applicable to derivative products, which includes Linked Securities, to
monitor trading in the Futures-Linked Securities. The issuer of a
series of Linked Securities is and will continue to be required to
comply with Rule 10A-3 under the Act for the initial and continued
listing of Linked Securities, as provided under Rule 14.11(d)(2)(F).
The Exchange notes that the proposed change is not intended to amend
any other component or requirement of Rule 14.11(d).
VSTOXX
    The information in this filing relating to the VSTOXX was taken
from the Web site of STOXX Limited (``STOXX''). The VSTOXX was
originally developed by STOXX in 2005 and is based on EURO STOXX 50
Index real-time option prices that are listed on the Eurex Deutschland
(``Eurex'') and are designed to reflect the market expectations of
near-term up to long-term volatility by measuring the square root of
the implied variances across all options of a given time to expiration.
The EURO STOXX 50 Index, Europe's leading Blue-chip index for the
Eurozone, provides a blue-chip representation of super sector leaders
in the Eurozone. The index covers 50 stocks from 12 Eurozone countries:
Austria, Belgium, Finland, France, Germany, Greece, Ireland, Italy,
Luxembourg, the Netherlands, Portugal and Spain.
    The model for VSTOXX aims at making pure volatility tradable--i.e.
it should be possible to replicate the indices with an options
portfolio which does not react to price fluctuations, but to changes in
volatility only. The VSTOXX does not measure implied volatilities of
at-the-money EURO STOXX 50 Index options, but the implied variance
across all options of a given time to expiry. A portfolio of EURO STOXX
50 Index options with different exercise price and weighting meets this
goal: the implied volatilities of all eligible options with a given
time to expiry are considered. The VSTOXX is calculated using a series
of sub-indices that are based on put and call options on the EURO STOXX
in eight expiry months with a maximum time to expiry of two years in
order to bracket a 30-day calendar period. The VSTOXX is calculated
using linear interpolation of the sub-indices whose times to expiration
closely surround the targeted fixed time to expiry. If there are no
such surrounding sub-indices, the VSTOXX is calculated by extrapolation
of two sub-indices with closest time to expiry. Because the calculation
relies on two sub-indices, VSTOXX is independent of a specific time to
expiry, which helps to eliminate effects that typically result in
strong volatility fluctuations close to expiry.

    STOXX will compute the index on a real-time basis throughout each
trading day, from 8:50 a.m. until 5:30 p.m. Central European Time
(``CET'') (3:50 a.m. until 12:30 p.m. Eastern Time (``ET'')). VSTOXX
levels will be calculated by STOXX and disseminated by major market
data vendors such as Bloomberg and Thomson Reuters.
VSTOXX Futures
    Additional information regarding the VSTOXX Futures can be found on
the Eurex Web site. Eurex \11\ began listing and trading VSTOXX Futures
in June 2009 under the ticker symbol FVS. VSTOXX Futures are cash
settled and trade between the hours of 7:30 a.m. and 10:30 p.m. CET
(2:30 a.m. and 5:30 p.m. ET). The VSTOXX Futures contract value is 100
Euros per index point of the underlying and it is traded to two decimal
places with a minimum price change of 0.05 points (equivalent to a
value of 5 Euros). The daily settlement price is determined during the
closing auction of the respective futures contract. The last trading
day and final settlement day is 30 calendar days prior to the third
Friday of the expiration month of the underlying options, which is
usually the Wednesday prior to the second to last Friday of the
respective maturity month.
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    \11\ The Exchange notes that Eurex is a member of the ISG and,
as such, the Exchange may obtain information regarding trading in
the underlying VSTOXX futures contracts. For a list of the current
members and affiliate members of ISG, see www.isgportal.com.
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    The monthly volume and open interest, in USD, as of the last day of
each month in 2015 for the VSTOXX Futures was as follows:

------------------------------------------------------------------------
                                         Monthly volume   Open interest
                                             (USD)            (USD)
------------------------------------------------------------------------
Jan-15................................    1,916,437,601      486,772,067
Feb-15................................    1,126,070,071      409,419,303
Mar-15................................    1,318,852,657      414,012,733
Apr-15................................    1,484,997,987      451,249,212
May-15................................    1,236,975,400      426,194,591
Jun-15................................    1,952,524,278      588,991,482
Jul-15................................    1,658,790,585      575,821,234
Aug-15................................    1,269,161,197      469,785,978
Sep-15................................    2,059,860,768      684,640,331
Oct-15................................    1,354,413,865      600,708,025
Nov-15................................    1,239,076,845      397,025,249
Dec-15................................   15,350,681,777      276,743,850
------------------------------------------------------------------------

    Both in the numbers shown above and throughout the history of
VSTOXX Futures, the monthly trading volume and open interest in VSTOXX
Futures has, subject to natural fluctuation in the market, continued to
grow. The Exchange notes that the monthly trading volume in the VSTOXX
Futures is very similar to the trading volume of the CBOE Volatility
Index[supreg] (VIX[supreg]) Futures prior to NYSE Arca, Inc. adding the
VIX Futures to the definition of futures reference asset in its
comparable rule,\12\ which, as noted above, the Exchange also added to
its rules related to Futures-Linked Securities. Much like the Futures-
Linked Securities linked to the VIX Futures, Futures-Linked Securities
linked to the VSTOXX Futures will provide investors with the ability to
better diversify and hedge their portfolios using an exchange listed
security without having to trade directly in the underlying futures
contracts.
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    \12\ See Securities Exchange Act Release No. 58968 (November 17,
2008), 73 FR 71082 (November 24, 2008) (NYSEArca-2008-111).
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    As such, the Exchange believes that the proposed amendment to add
VSTOXX Futures as an underlying Futures Reference asset will facilitate
the listing and trading of an additional Futures-Linked Security that
will enhance competition among market participants, to the benefit of
investors and the marketplace.
2. Statutory Basis
    The Exchange believes that the proposal is consistent with Section
6(b) of the Act \13\ in general and Section 6(b)(5) of the Act \14\ in
particular in that it is designed 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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    \13\ 15 U.S.C. 78f.
    \14\ 15 U.S.C. 78f(b)(5).
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    The proposed rule change is designed to promote just and equitable
principles of trade, to perfect the mechanism of a free and open market
and, in general, to protect investors and the public interest in that
it will facilitate the listing and trading of additional types of
Futures-Linked Securities that will enhance competition among market
participants, to the benefit of investors and the marketplace. As noted
above, the Exchange has in place surveillance procedures relating to
trading in Futures-Linked Securities and may obtain information
regarding both the Futures-Linked Securities and VSTOXX Futures via ISG
from other exchanges that are members of ISG or with which the Exchange
has entered into a comprehensive surveillance sharing agreement. In
addition, as noted above, investors will have ready access to
information on an intraday basis regarding: (i) The value of the
Futures Reference Asset, which will be calculated and widely
disseminated by one or more major market data vendors on at least a 15-
second basis during the Exchange's regular market session; (ii) for
Futures-Linked Securities that are periodically redeemable, the
Intraday Indicative Value of the securities, which must be calculated
and widely disseminated by the Exchange or one or more major market
data vendors on at least a 15-second basis during the Exchange's
regular market session; and (iii) information regarding market price
and trading of Futures-Linked Securities will be continually available
on a real-time basis throughout the day on brokers' computer screens
and other electronic services, and quotation and last sale information
for the securities will be available on the facilities of the CTA.
    Further, any Futures-Linked Securities linked to VSTOXX Futures
would be required to meet both the initial and continued listing
standards, including certain of those named above, under Rule
14.11(d)(2)(K)(iv)(b) and (c) or be subject to delisting or removal
proceedings, which include: (i) That the value of the Futures Reference
Asset be calculated and widely disseminated by one or more major market
data vendors on at least a 15-second basis during the Exchange's
regular market session; (ii) for Futures-Linked Securities that are
periodically redeemable, the Intraday Indicative Value of the
securities must be calculated and widely disseminated by the Exchange
or one or more major market data vendors on at least a 15-second basis
during the Exchange's regular market session; (iii) the aggregate
market value or the principal amount of the Futures-Linked Securities
must be at least $400,000; (iv) the value of the VSTOXX Futures must be
calculated and available; and (v) any other event occurs or condition
exists which in the opinion of the Exchange makes further dealings on
the Exchange inadvisable. Any Futures-Linked Securities linked to
VSTOXX Futures would also be required to meet the listing standards
applicable to all Linked Securities under 14.11(d)(2). Finally, all
Linked Securities listed pursuant to Rule 14.11(d) are included within
the definition of ``security'' or ``securities'' as such terms are used
in the Rules of the Exchange and, as such, are subject to the full
panoply of Exchange Rules and procedures that currently govern the
trading of securities on the Exchange. Additionally, trading in the
securities will be halted under the conditions specified in BZX Rule
11.18. Trading may also be halted because of market conditions, for
reasons that, in the view of the Exchange, make trading in the

securities inadvisable, or the circumstances set forth in BZX Rule
14.11(d)(2)(H), which sets forth circumstances under which Linked
Securities may be halted.
    As noted above, both in the context presented herein and throughout
the history of VSTOXX Futures, the monthly trading volume and open
interest in VSTOXX Futures has, subject to natural fluctuation in the
market, continued to grow. The Exchange notes that the monthly trading
volume in the VSTOXX Futures is very similar to the trading volume of
the CBOE Volatility Index[supreg] (VIX[supreg]) Futures prior to NYSE
Arca, Inc. adding the VIX Futures to the definition of futures
reference asset in its comparable rule,\15\ which, as noted above, the
Exchange also added to its rules related to Futures-Linked Securities.
Much like the Futures-Linked Securities linked to the VIX Futures,
Futures-Linked Securities linked to the VSTOXX Futures will provide
investors with the ability to better diversify and hedge their
portfolios using an exchange listed security without having to trade
directly in the underlying futures contracts. The Exchange also
believes that the proposed rule change would fulfill the intended
objective of Rule 19b-4(e) under the Act by allowing Futures-Linked
Securities linked to the VSTOXX Futures that satisfy the listing
standards in Rule 14.11(d) to be listed and traded without separate
Commission approval. However, as proposed, the Exchange would continue
to file separate proposed rule changes before the listing and trading
of Futures-Linked Securities that do not satisfy the criteria of Rule
14.11(d)(2)(K)(iv). As such, the Exchange believes that the proposed
amendment to add VSTOXX Futures as an underlying Futures Reference
asset will facilitate the listing and trading of an additional Futures-
Linked Security that will enhance competition among market
participants, to the benefit of investors and the marketplace.
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    \15\ See Securities Exchange Act Release No. 58968 (November 17,
2008), 73 FR 71082 (November 24, 2008) (NYSEArca-2008-111).
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    For the above reasons, the Exchange believes that the proposed rule
change is consistent with the requirements of Section 6(b)(5) of the
Act.

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

    The Exchange does not believe that the proposed rule change will
impose any burden on competition that is not necessary or appropriate
in furtherance of the purpose of the Act. Instead, the Exchange
believes that the proposed rule change would facilitate the listing and
trading of additional types of Futures-Linked Securities, which will
enhance competition among market participants, to the benefit of
investors and the marketplace and provide investors with the ability to
better diversify and hedge their portfolios using an exchange listed
security without having to trade directly in the underlying futures
contracts. The Exchange believes that this would reduce the time frame
for bringing Futures-Linked Securities linked to the VSTOXX Futures to
market, thereby reducing the burdens on issuers and other market
participants and promoting competition.

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

    The Exchange has neither solicited nor received written comments on
the proposed rule change.

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

    Within 45 days of the date of publication of this notice in the
Federal Register or within such longer period up to 90 days (i) as the
Commission may designate if it finds such longer period to be
appropriate and publishes its reasons for so finding or (ii) as to
which the self-regulatory organization consents, the Commission will:
(a) By order approve or disapprove such proposed rule change; or (b)
institute proceedings to determine whether the proposed rule change
should be disapproved.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-BatsBZX-2016-26 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-BatsBZX-2016-26. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549 on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of such filing will also be available
for inspection and copying at the principal offices of the Exchange.
All comments received will be posted without change; the Commission
does not edit personal identifying information from submissions. You
should submit only information that you wish to make available
publicly. All submissions should refer to File Number SR-BatsBZX-2016-
26, and should be submitted on or before August 2, 2016.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\16\
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    \16\ 17 CFR 200.30-3(a)(12).
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Brent J. Fields,
Secretary.
[FR Doc. 2016-16380 Filed 7-11-16; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register: September 24, 2009 (Volume 74, Number 184)]
[Notices]
[Page 48760-48761]
[DOCID:fr24se09-76]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0444]

Schmid Laboratories, Inc. et al.; Proposal To Withdraw Approval
of Five New Drug Applications; Opportunity for a Hearing

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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SUMMARY:  The Food and Drug Administration (FDA) is announcing an
opportunity to request a hearing on the agency's proposal to withdraw
approval of five new drug applications (NDAs) from multiple sponsors.
The basis for the proposal is that the sponsors have repeatedly failed
to file required annual reports for these applications.

DATES:  Submit written requests for a hearing by October 26, 2009;
submit data and information in support of the hearing request by
November 23, 2009.

ADDRESSES:  Requests for a hearing, supporting data, and other comments
are to be identified with Docket No. FDA-2009-N-0444 and submitted to
the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:  Florine P. Purdie, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6366, Silver Spring, MD 20993-0002, 301-
796-3601.

SUPPLEMENTARY INFORMATION: The holders of approved applications to
market new drugs for human use are required to submit annual reports to
FDA concerning each of their approved applications in accordance with
Sec.  314.81 (21 CFR 314.81). The holders of the approved applications
listed in table 1 of this document have failed to submit the required
annual reports and have not responded to the agency's request by
certified mail for submission of the reports.

                                 Table 1
------------------------------------------------------------------------
 Application No.            Drug                     Applicant
------------------------------------------------------------------------
NDA 5-766          Ramses Vaginal Jelly   Schmid Laboratories, Inc.,
                                           Route 46 West, Little Falls,
                                           NJ 07424
------------------------------------------------------------------------
NDA 7-220          Synthetic Vitamin A    Merck & Co., Inc., 770
                    (vitamin A             Sumneytown Pike, P.O. Box 4,
                    palmitate)             West Point, PA 19486
------------------------------------------------------------------------
NDA 8-595          Immolin Vaginal Cream  Schmid Laboratories, Inc.
                    Jel
------------------------------------------------------------------------
NDA 8-612          Silicote               Arnar-Stone Laboratories,
                    (simethicone)          Inc., 601 East Kensington
                    Ointment               Rd., Mount Prospect, IL 60056
------------------------------------------------------------------------
NDA 10-915         Q.E.D. Hairgroom       A.R. Winarick, Inc., 783
                    (captan)               Palisade Ave., Cliffside, NJ
                                           07010
------------------------------------------------------------------------

    Therefore, notice is given to the holders of the approved
applications listed in table 1 of this document and to all other
interested persons that the Director of the Center for Drug Evaluation
and Research proposes to issue an order under section 505(e) of the
Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355(e))
withdrawing approval of the applications and all amendments and
supplements thereto on the ground that the applicants have failed to
submit reports required under Sec.  314.81.
    In accordance with section 505 of the act and part 314 (21 CFR part
314), the applicants are hereby provided an opportunity for a hearing
to show why the applications listed previously should not be withdrawn
and an opportunity to raise, for administrative determination, all
issues relating to the legal status of the drug products covered by
these applications.
    An applicant who decides to seek a hearing shall file the
following: (1) A written notice of participation and request for a
hearing (see DATES), and (2) the data, information, and analyses relied
on to demonstrate that there is a genuine and substantial issue of fact
that requires a hearing (see DATES). Any other interested person may
also submit comments on this notice. The procedures and requirements
governing this notice of opportunity for a hearing, notice of
participation and request for a hearing, information and analyses to
justify a hearing, other comments, and a grant or denial of a hearing
are contained in Sec.  314.200 and in 21 CFR part 12.
    The failure of an applicant to file a timely written notice of
participation and request for a hearing, as required by Sec.  314.200,
constitutes an election by that applicant not to avail itself of the
opportunity for a hearing concerning the proposal to withdraw approval
of the applications and constitutes a waiver of any contentions
concerning the legal status of the drug products. FDA will then
withdraw approval of the applications and the drug products may not
thereafter lawfully be marketed, and FDA will begin appropriate
regulatory action to remove the products from the market. Any new drug
product marketed without an approved new drug application is subject to
regulatory action at any time.
    A request for a hearing may not rest upon mere allegations or
denials, but must present specific facts showing that there is a
genuine and substantial issue of fact that requires a hearing. Reports
submitted to remedy the deficiencies must be complete in all respects
in accordance with Sec.  314.81. If the submission is not complete or
if a request for a hearing is not made in the required format or with
the required reports, the Commissioner of Food and Drugs will enter
summary judgment against the person who requests the hearing, making
findings and conclusions, and denying a hearing.
    All submissions under this notice of opportunity for a hearing must
be filed in four copies. Except for data and information prohibited
from public disclosure under 21 U.S.C. 331(j) or 18 U.S.C. 1905, the
submissions may be seen in the Division of Dockets Management (see
ADDRESSES) between 9 a.m. and 4 p.m., Monday through Friday, or on the
Internet at http://www.regulations.gov.
    This notice is issued under the Federal Food, Drug, and Cosmetic
Act (sec. 505 (21 U.S.C. 355)) and under authority delegated to the
Director, Center for Drug Evaluation and Research, by the Commissioner
of Food and Drugs.

    Dated: September 9, 2009.
Douglas C. Throckmorton,
Deputy Director, Center for Drug Evaluation and Research.
[FR Doc. E9-23005 Filed 9-23-09; 8:45 am]

BILLING CODE 4160-01-S


From<EMAIL_ADDRESS>Sent:	Monday, October 05, 2009 9:34 PM
-----Forwarded by Melanie King/RTP/USEPA/US on 10/05/2009 09:26PM -----
To: Melanie King/RTP/USEPA/US@EPA
From: "Stachowicz, Bob"<EMAIL_ADDRESS>Date: 10/05/2009 03:53PM
cc: "Palmer, Lynn"<EMAIL_ADDRESS>"Siehoff, Jack"
<EMAIL_ADDRESS>"Towner, Stephen"<EMAIL_ADDRESS>
"McDowell, Bob"<EMAIL_ADDRESS>"Boeh, Cynthia"
<EMAIL_ADDRESS>"Spaulding, Dennis"<EMAIL_ADDRESS>Subject: Additional Dresser-Waukesha RICE NESHAP Test Data and Comments
References:   EPA Proposed NESHAP Rule for RICE -- 74FR9698;  Docket ID No. EPA-HQ-OAR-2008-
0708
                    Waukesha comments dated June 2, 2009
                    Waukesha e-mail; R. Stachowicz to M. King dated August 12, 2009

Dear Ms. King,

    In my previous e-mail to you, dated August 12, 2009, Dresser-Waukesha said that we had decided to
acquire additional data in our Engineering Laboratory on the formaldehyde - THC relationship in the
exhaust of a 4SRB SI, natural gas engine and across a catalyst in the exhaust stream to support our
comments to Docket ID No. EPA-HQ-OAR-2008-0708 that THC was a much more suitable surrogate for
HAP for 4SRB engines than the currently specified formaldehyde.  Dresser-Waukesha and our third party
testing firm, Clean Air Engineering (CAE) of Palatine, IL, ran a substantial program of 46 distinct
operating conditions and obtained performance and emissions data both before (engine out) and after a
commercially available, non-selective catalytic reduction, NSCR or 3-way, catalyst.  Our two reports of
the testing and a cover letter with additional comments are attached for your use and inclusion in the
docket.

    Dresser-Waukesha believes that these data and reports strongly support our recommendation to use
THC as a suitable, cost effective surrogate for HAP for 4SRB engines in all RICE NESHAP rules.

    For expediency, I have sent these documents as electronic attachments to this e-mail.  Can you
please confirm to me that you received everything?  If you would like hard copies please let me know
and Waukesha will send them by express delivery.  If you need anything else please do not hesitate to
contact me.

Sincerely,
Robert  S tachowicz
________________________________________________________________________________________________________
______________________
Robert Stachowicz, PE | Staff Engineer | Dresser, Inc., Dresser Waukesha | 1101 West St. Paul Avenue, Waukesha, WI, 53188 |
262.549.2753 |<PHONE_NUMBER> (fax)

Attachments (3):    Comments Letter
                            TR-4858 Dresser-Waukesha Report
                            #10845-R1 CAE Report

This email, including any attached files, may contain confidential and privileged information for the sole use of the
intended recipient(s). Any review, use, distribution or disclosure by others is strictly prohibited. Distribution of sensitive
technical material may violate applicable export and trade laws. If you are not the intended recipient or authorized to
receive information for the recipient(s), please contact the sender by reply email and delete all copies of this message. E-
mail may be susceptible to data corruption, interception, unauthorized amendment, viruses and delays or the
consequences thereof. Accordingly this e-mail and any attachments are opened at your own risk . Unless expressly stated
in this e-mail, nothing in this message should be construed as a digital or electronic signature.


[Federal Register Volume 86, Number 215 (Wednesday, November 10, 2021)]
[Rules and Regulations]
[Pages 62481-62482]
[FR Doc No: 2021-24589]

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

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2021-0799]

Safety Zone; Four Seasons Hotel Fireworks Display Event, New
Orleans, LA

AGENCY: Coast Guard, Department of Homeland Security (DHS).

ACTION: Notification of enforcement of regulation.

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

SUMMARY: The Coast Guard will enforce a temporary safety zone for a
fireworks display located on the navigable waters

of the Lower Mississippi River between Mile Marker (MM) 94 and MM 95.
This action is needed to provide for the safety of life on these
navigable waterways during the event. During the enforcement periods,
the operator of any vessel in the regulated area must comply with
directions from the Patrol Commander or any Official Patrol displaying
a Coast Guard ensign.

DATES: The regulations in 33 CFR 165.845 will be enforced from 9:00
p.m. to 10:00 p.m. on November 17, 2021.

FOR FURTHER INFORMATION CONTACT: If you have questions about this
notification of enforcement, call or email Lieutenant Commander William
Stewart, Sector New Orleans, U.S. Coast Guard; telephone<PHONE_NUMBER>,
email [email protected].

SUPPLEMENTARY INFORMATION: The Coast Guard will enforce safety zone
located in 33 CFR 165.845 for the Four Seasons Hotel Fireworks Display
event. The regulations will be enforced from 9:00 p.m. through 10:00
p.m. on November 17, 2021. This action is being taken to provide for
the safety of life on navigable waterways during this event, which will
be located between MM 94 and MM 95 above Head of Passes, Lower
Mississippi River, LA. During the enforcement periods, if you are the
operator of a vessel in the regulated area you must comply with
directions from the Patrol Commander or any Official Patrol displaying
a Coast Guard ensign.
    In addition to this notification of enforcement in the Federal
Register, the Coast Guard plans to provide notification of this
enforcement period via Marine Safety Information Bulletin and Broadcast
Notice to Mariners.

    Dated: October 29, 2021.
W.E. Watson,
Captain, U.S. Coast Guard, Captain of the Port Sector New Orleans.
[FR Doc. 2021-24589 Filed 11-9-21; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 88, Number 146 (Tuesday, August 1, 2023)]
[Notices]
[Page 50182]
[FR Doc No: 2023-16131]

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

DEPARTMENT OF LABOR

Occupational Safety and Health Administration

[Docket No. OSHA-2007-0083]

Applied Research Laboratories of South Florida, LLC; Voluntary
Termination of Recognition as a Nationally Recognized Testing
Laboratory

AGENCY: Occupational Safety and Health Administration (OSHA), Labor.

ACTION: Notice.

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

SUMMARY: In this notice, OSHA announces the voluntary termination of
recognition granted to Applied Research Laboratories of South Florida,
LLC as a Nationally Recognized Testing Laboratory (NRTL).

DATES: The voluntary termination of recognition specified by this
notice becomes effective on August 1, 2023.

FOR FURTHER INFORMATION CONTACT: Information regarding this notice is
available from the following sources:
    Press inquiries: Contact Mr. Frank Meilinger, Director, OSHA Office
of Communications, U.S. Department of Labor; telephone:<PHONE_NUMBER>;
email: [email protected].
    General and technical information: Contact Mr. Kevin Robinson,
Director, Office of Technical Programs and Coordination Activities,
Directorate of Technical Support and Emergency Management, Occupational
Safety and Health Administration, U.S. Department of Labor; telephone:
(202) 693-2110; email: [email protected].

SUPPLEMENTARY INFORMATION:

I. Notice of Voluntary Termination of Recognition as a Nationally
Recognized Testing Laboratory

    On April 25, 2018, OSHA granted Applied Research Laboratories of
South Florida, LLC (ARL) recognition as a Nationally Recognized Testing
Laboratory (NRTL). The NRTL Program regulation, 29 CFR 1910.7 App. A,
provides that, ``[a]t any time, a recognized NRTL may voluntarily
terminate its recognition, either in its entirety or with respect to
any area covered in its recognition, by giving written notice to
OSHA,'' that ``[t]he written notice shall state the date as of which
the termination is to take effect, and that [t]he Assistant Secretary
shall inform the public of any voluntary termination by Federal
Register notice.''
    ARL notified OSHA by a letter dated April 19, 2023 (OSHA-2007-0083-
0057), that it would be closing its business effective July 31, 2023.
In a subsequent email, dated May 25, 2023 (OSHA-2007-0038-0058), ARL
confirmed that this letter constituted a voluntary and complete
termination of ARL's recognition as a NRTL, effective August 1, 2023,
as well as a voluntary withdrawal of any open NRTL scope expansions and
NRTL renewal applications previously submitted to OSHA, also effective
August 1, 2023.
    Therefore, pursuant to the NRTL Program regulation, OSHA is
informing the public that ARL has voluntary terminated its recognition.

II. Authority and Signature

    James S. Frederick, Deputy Assistant Secretary of Labor for
Occupational Safety and Health, 200 Constitution Avenue NW, Washington,
DC 20210, authorized the preparation of this notice. Accordingly, the
agency is issuing this notice pursuant to Section 29 U.S.C. 657(g)(2),
Secretary of Labor's Order No. 8-2020 (85 FR 58393, Sept. 18, 2020),
and 29 CFR 1910.7.

    Signed at Washington, DC, on July 24, 2023.
James S. Frederick,
Deputy Assistant Secretary of Labor for Occupational Safety and Health.
[FR Doc. 2023-16131 Filed 7-31-23; 8:45 am]
BILLING CODE 4510-26-P


[Federal Register Volume 87, Number 164 (Thursday, August 25, 2022)]
[Notices]
[Pages 52421-52422]
[FR Doc No: 2022-18354]

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

SECURITIES AND EXCHANGE COMMISSION

[Investment Company Act Release No. 34680; File No. 812-15287]

Brightwood Capital Corporation I, et al.

August 22, 2022.
AGENCY: Securities and Exchange Commission (``Commission'' or ``SEC'').

ACTION: Notice.

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

    Notice of application for an order (``Order'') under sections 17(d)
and 57(i) of the Investment Company Act of 1940 (the ``Act'') and rule
17d-1 under the Act to permit certain joint transactions otherwise
prohibited by sections 17(d) and 57(a)(4) of the Act and rule 17d-1
under the Act.

SUMMARY OF APPLICATION: Applicants request an order to permit certain
business development companies (``BDCs'') and closed-end management
investment companies to co-invest in portfolio companies with each
other and with certain affiliated investment entities.

APPLICANTS: Brightwood Capital Corporation I, Brightwood Capital
Advisors, LLC, Brightwood SPV Advisors, LLC, Brightwood Capital SBIC
III, LP, Brightwood Capital Fund V, LP, Brightwood Capital Fund V-U,
LP, Brightwood Capital Offshore Fund V, LP, Brightwood Capital Offshore
Feeder Fund V, LP, Brightwood Capital Offshore Fund V-U, LP, Brightwood
Capital Offshore Feeder Fund V-U, LP, BCOF Capital V, LP, Brightwood
Capital MM CLO 2019-1, Ltd., Brightwood Capital MM CLO 2020-1, Ltd.,
Brightwood Capital MM CLO 2021-2, Ltd., and Brightwood Capital MM CLO
2022-1, Ltd.

FILING DATES: The application was filed on December 3, 2021, and
amended on May 10, 2022 and August 16, 2022.

HEARING OR NOTIFICATION OF HEARING: An order granting the requested
relief will be issued unless the Commission orders a hearing.
Interested persons may request a hearing on any application by emailing
the SEC's Secretary at [email protected] and serving the
Applicants with a copy of the request by email, if an email address is
listed for the relevant Applicant below, or personally or by mail, if a
physical address is listed for the relevant Applicant below. Hearing
requests should be received by the Commission by 5:30 p.m. on September
16, 2022, and should be accompanied by proof of service on applicants,
in the form of an affidavit or, for lawyers, a certificate of service.
Pursuant to rule 0-5 under the Act, hearing requests should state the
nature of the writer's interest, any facts bearing upon the
desirability of a hearing on the matter, the reason for the request,
and the issues contested. Persons who wish to be notified of a hearing
may request notification by emailing the Commission's Secretary at
[email protected].

ADDRESSES: The Commission: [email protected]. Applicants:
Darilyn T. Olidge, Esq., [email protected].

FOR FURTHER INFORMATION CONTACT: Asen Parachkevov, Senior Counsel, or
Terri Jordan, Branch Chief, at<PHONE_NUMBER> (Division of Investment
Management, Chief Counsel's Office).

SUPPLEMENTARY INFORMATION: For Applicants' representations, legal

analysis, and conditions, please refer to Applicants' second amended
and restated application, dated August 16, 2022, which may be obtained
via the Commission's website by searching for the file number at the
top of this document, or for an Applicant using the Company name search
field, on the SEC's EDGAR system. The SEC's EDGAR system may be
searched at, http://www.sec.gov/edgar/searchedgar/legacy/companysearch.html. You may also call the SEC's Public Reference Room
at<PHONE_NUMBER>.
    For the Commission, by the Division of Investment Management, under
delegated authority.

J. Matthew DeLesDernier,
Deputy Secretary.
[FR Doc. 2022-18354 Filed 8-24-22; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 84, Number 211 (Thursday, October 31, 2019)]
[Notices]
[Page 58400]
[FR Doc No: 2019-23843]

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

DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4462-DR; Docket ID FEMA-2019-0001]

Louisiana; Amendment No. 1 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: This notice amends the notice of a major disaster declaration
for the State of Louisiana (FEMA-4462-DR), dated September 19, 2019,
and related determinations.

DATES: This amendment was issued October 17, 2019.

FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The notice of a major disaster declaration
for the State of Louisiana is hereby amended to include the following
area among those areas determined to have been adversely affected by
the event declared a major disaster by the President in his declaration
of September 19, 2019.

    St. Mary Parish for Public Assistance.

The following Catalog of Federal Domestic Assistance Numbers (CFDA)
are to be used for reporting and drawing funds: 97.030, Community
Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling;
97.033, Disaster Legal Services; 97.034, Disaster Unemployment
Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048,
Disaster Housing Assistance to Individuals and Households In
Presidentially Declared Disaster Areas; 97.049, Presidentially
Declared Disaster Assistance--Disaster Housing Operations for
Individuals and Households; 97.050 Presidentially Declared Disaster
Assistance to Individuals and Households--Other Needs; 97.036,
Disaster Grants--Public Assistance (Presidentially Declared
Disasters); 97.039, Hazard Mitigation Grant.

Pete Gaynor,
Acting Administrator, Federal Emergency Management Agency.
[FR Doc. 2019-23843 Filed 10-30-19; 8:45 am]
BILLING CODE 9111-23-P


	UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

	WASHINGTON, D.C.  20460

OFFICE OF

PREVENTION, PESTICIDES AND

TOXIC SUBSTANCES

April 23, 2007

Memorandum

SUBJECT:	Antimycin A:  Response to Public Comments on the Health Effects
Division (HED) Considerations for the Reregistration Eligibility
Decision (RED) Document

		Barcode: DP# 338642

FROM:	Deborah Smegal, MPH, Toxicologist/Risk Assessor

		Byong-Han Chin, Toxicologist

		Timothy Dole, Industrial Hygienist

		Christine Olinger, Senior Scientist

		Re-Registration Branch 1

		Health Effects Division (HED) (7509P)

THRU:		Michael Metzger, Branch Chief

		Reregistration Branch I

		Health Effects Division (HED), (7509P)

TO:		Lance Wormell, Chemical Review Manager

Reregistration Branch 2

Special Review and Reregistration Division (SRRD) (7508P)

Background:

This document represents the Health Effects Division’s (HED) response
to public comments received in March 2007

GENERAL COMMENTS:

Comment:

There are uncertainties regarding effects to humans due to an incomplete
database.

EPA Response:

The HED memorandum acknowledges a lack of toxicity data for antimycin A.
 However, antimycin A is a restricted use pesticide used only by trained
and/or certified applicators that is used in quantities of several
hundred pounds per year in the U.S.   There is currently only one
registered product (Fintrol® Concentrate) that is used at low
application rates resulting in water concentrations generally less than
25 ppb antimycin A, and the Agency will require additional label
language to preclude significant human exposure.  Given these
considerations, HED believes there are minimal risks to human health
from antimycin A.

Comment:

Based on the potential for residues, a tolerance should be established
for antimycin A in fish (see Gilderhus et al. 1969, Ritter et al. 1966).

EPA Response:

The catfish farm use is considered to be a non-food use because the
Agency intends to require label restrictions not to harvest fish for 1
year following treatment with antimycin A to ensure that fish residues
will be non-detectable.  In addition, antimycin A appears to have a low
potential to bioaccumulate in aquatic organisms (EFED memo, Young and
Steeger 12/12/06, D310730).  Thus, a food tolerance is not necessary
under these use conditions.

COMMENTS FROM ANN MCCAMPBELL, MARCH 19, 2007

Comment:

I do not agree that sub-chronic impacts of antimycin can be dismissed
because

there was no ?gross or microscopic? pathology demonstrated (p. 6). This
ignores the possibility of functional impacts, such as on the endocrine
or immune systems, which can be significantly impacted without showing
structural

abnormalities. Microscopic analysis would also miss abnormalities that
are too

small to be seen with a standard microscope.

EPA Response:

The document was revised to add that the Agency lacks toxicology
information regarding endocrine and immunological toxicity of antimycin
A.

Comment:

I also disagree that because antimycin has a low vapor pressure and
because it

will preferentially partition into acetone rather than air that this
means that antimycin will not become airborne (p. 8). My experience with
chlorpyrifos, which is also relatively non-volatile, was that when mixed
with petroleum solvents in the product Dursban, it contaminated my house
when fumes entered open windows. I believe the volatile component of
Dursban acted as a carrier to volatilize the otherwise less volatile
chlorpyrifos. In any case, the claim that antimycin is not expected to
become airborne should be recognized as only theoretical and until this
hypothesis is empirically tested, should not be given much weight.

EPA Response:

The memorandum was revised to state the following:  “Antimycin A has a
very low pressure of 2.31x10-15 mmHg at ambient temperatures, and thus
inhalation exposure to antimycin A vapors is expected to be minimal….
Backpack applications, however, may result in significant aerosols
exposures if high concentrations are applied, and it is therefore
recommended that the label be clarify to specify the solution strength
for backpack application.”

HED believes the comments related to chlorpyrifos (dursban) are not
directly relevant to antimycin A.

Comment:

An assumption is made that antimycin affected the intestinal flora of
rats who

developed diarrhea after consuming antimycin (p.7). Is there any
documentation

of this? How likely is this explanation given the fact that antimycin
has no

effect on bacteria?

EPA Response:

The document was modified to state the following:  “Increased
incidence of diarrhea and soft stool was considered as a
treatment-related effect.  The LOAEL was 0.5 mg/kg/day based on
occurrence of increased incidence of diarrhea or soft feces.  The NOAEL
was not established.”

Comment:

The worst case scenario is described as drinking water contamination at
the

application concentration (p. 9), but the worst case would actually be a

misapplication or spill scenario, which were not, but should be,
analyzed.

EPA Response:

It is current Agency policy to conduct assessments assuming that
individuals follow the label instructions.

Comment:

More attention should be paid to evidence that antimycin causes DNA
strand

breaks and is a mutagen.

EPA Response:

No mutagenicity studies are available in our database to indicate that
antimycin A is mutagenic.  However, the published literature including
the ToxNet/Environmental Mutagen Information Center (EMIC), did not show
evidence that antimycin A by itself is a mutagen.  Many references used
antimycin A with other chemicals to study a mutation.

COMMENTS FROM ANN MCCAMPBELL, MARCH 19, 2007 RELATED TO THE WATER
QUALITY CONTROL COMMISSION HEARING ON NEW MEXICO DEPARTMENT OF GAME AND
FISH PETITION DATED SEPTEMBER 12, 2002

Comment:

Antimycin A is a highly toxic pesticide and poison. It is not an
antibiotic (Exhibit 1) or a

pharmaceutical agent. Although antimycin A is derived from bacteria, it
has more in

common with cyanide than penicillin. Like cyanide, antimycin A blocks
electron

transport in mitochondria causing cellular anoxia.

EPA Response:

The HED memorandum was revised to remove reference to antimycin A as an
antibiotic.

Comment:

Fintrol concentrate carries the highest acute toxicity rating given by
the U.S.

Environmental Protection Agency (EPA), Toxicity Category I. The label
contains the

warning “DANGER POISON” next to a skull and crossbones. Under
“hazards to

humans and domestic animals” it says this product is “FATAL IF
SWALLOWED” and

“MAY BE FATAL IF ABSORBED THROUGH THE SKIN”.

According to its Material Safety Data Sheet (Exhibit 2), the oral LD 50
of antimycin A in

rats is 30 mg/kg, that is, it takes 30 mg/kg of ingested antimycin A to
kill half the test

animals. According to an EPA Chemical Profile (Exhibit 3), the LD 50 for
guinea pigs is

even lower at an extraordinary 1.8 mg/kg. Pesticides with an oral LD 50
less than 50

mg/kg meet the criteria for EPA Toxicity Category I. To put this in
perspective, pesticides in the other three EPA toxicity categories have
much higher oral LD 50 values.

The oral LD 50 for Category II pesticides is 50-500 mg/kg, for Category
III pesticides it

is 500-5000 mg/kg, and is greater than 5000 mg/kg for Category IV
pesticides (1).

EPA Response:

The HED memorandum indicates that antimycin A technical is in toxicity
category 1 for acute oral toxicity.  The document was revised to include
the LD50 of 28 mg/kg.  The recent acute toxicity study for the end-use
product that contains 23% antimycin A (fintrol concentrate; MRID
45937201)  produced a higher LD50 of 316 mg/kg (combined sexes), which
is considered to be toxicity category 2.

Comment:

The Hazards Information section of the Material Safety Data Sheet
(Exhibit 2) states that

routes of entry for antimycin A include the skin, inhalation, and
ingestion. The ingestion

hazard rating is “highly toxic”. Antimycin A is also noted to be an
eye, skin and

respiratory irritant. Target organs include eyes, skin, respiratory
tract, cardiovascular

system, nervous system, kidneys, and possibly fetus. Inhalation of
vapors or aerosol can

irritate the eyes, nose, and respiratory tract. Direct contact with skin
or eyes can produce

severe irritation. And systemic intake can produce a decrease in blood
pressure, nausea,

light headedness, dizziness, excitement, incoordination, weakness, loss
of coordinated

speech and drowsiness. Medical conditions said to be aggravated by
antimycin A

exposure are pre-existing eye, skin, respiratory, kidney, nervous system
or cardiovascular

ailments.

A University of California at Santa Cruz Laboratory Standard Operating
Procedure guide

on antimycin A (Exhibit 4) states that this material is considered a
Particularly Hazardous

Substance by the CAL OSHA Lab Standard. It also says that antimycin A is
“highly

toxic” and “may be fatal if swallowed, absorbed through skin, or
inhaled”. It notes that

“respiratory distress, impaired reflexes, incoordination, and terminal
symptoms consistent

with CNS (central nervous system) depression have been reported in
experimental

animals poisoned by the oral or parenteral route.”

ToxNet Hazardous Substance Databank Information on antimycin A, which
includes data

from PoisonDex (Exhibit 5), states that respiratory distress,
incoordination, impaired

reflexes, and CNS (central nervous system) depression have occurred in
animals. It

further notes that the minimum lethal human exposure level is unknown.

EPA Response:

The HED memorandum was revised to more clearly indicate that antimycin A
is a dermal, eye and respiratory irritant.

The following text was added to the HED memorandum:  “Neurotoxicity:
Incoordination, impaired reflexes and respiratory distress have been
reported in mice injected intravenously with antimycin A. (HSDB
2007).”

Comment:

Besides its extreme acute toxicity, ToxNet also states that antimycin A
is an experimental

MUTAGEN. The NIOSH Registry of Toxic Effects of Chemical Substances
(RTECS)

(Exhibit 6) also includes “mutation data” on antimycin A. And there
are 36 references

regarding antimycin on the ToxNet Environmental Mutagen Information
Center (EMIC)

web page (2). At least one study describes antimycin-induced DNA
fragmentation and

strand breaks (Exhibit 7).

EPA Response:

No mutagenicity studies are available in our database to indicate that
antimycin A is mutagenic.  Although RTECS indicates that antimycin A is
a mutagen, no citations are provided to support this conclusion (RTECS
2006).  However, the published literatures including the
ToxNet/Environmental Mutagen Information Center (EMIC), did not show
evidence that Antimycin A by itself (i.e., when tested alone) is a
mutagen.  Many of the references cited by the commentor appeared to test
antimycin A with other chemicals.   Regarding one study which involves
antimycin A with DNA fragmentation and strand breaks (Exhibit 7, Garberg
et al. 1988)), genotoxic activity was also not demonstrated by antimycin
A by itself.   In this study (Garberg et al. 1988) that employed the DNA
alkaline unwinding assay (see reference), genotoxic activity was not
demonstrated by antimycin A tested at concentrations in the range of 1.5
X 10-5 to 150 X 10-5 mol/L.  [NOTE:  The DNA alkaline unwinding assay is
based on the measurement of the proportions of single- to
double-stranded DNA by alkaline unwinding and hydroxyapatite elution in
mouse lymphoma cells treated in vitro with various chemicals.]

Reference

GARBERG P; AKERBLOM EL; BOLCSFOLDI G.  Evaluation of a Genotoxicity Test
Measuring DNA-Strand Breaks in Mouse Lymphoma Cells by Alkaline
Unwinding and Hydroxyapatite Elution.  MUTAT RES 203:155-176,1988

Comment:

Perhaps most importantly, there is a disturbing lack of knowledge about
the full range of

toxicity of antimycin A. Fintrol was initially registered in 1977 (3)
before the EPA

adopted more stringent registration requirements. In a 1987 EPA Chemical
Profile on

Antimycin A (Exhibit 3) data was “not found” in most categories
evaluated -- from

physical and chemical properties to health hazards -- despite a search
of 15 data sources.

In addition, the California Department of Pesticide Regulation recently
rejected the

registration of Fintrol in that state because of insufficient data
regarding its toxicity and

environmental fate (Exhibit 8). There are as well concerns among fish
managers that

Fintrol may lose its federal EPA registration (Exhibits 1 & 9).

EPA Response:

The HED memorandum acknowledges a lack of toxicity data for antimycin A.
 However, antimycin A is a restricted use pesticide used only by trained
and/or certified applicators that is used in quantities of several
hundred  pounds per year in the U.S.   There is currently only one
registered product (Fintrol® Concentrate) that is used at low
application rates resulting in water concentrations generally less than
25 ppb antimycin A, and the Agency will require additional label
language to preclude significant human exposure.  Given these
considerations, HED believes there are minimal risks to human health
from antimycin A.

Comments from Food and Water Watch, Washington D.C.  March 16, 2007.

Comment:

The document submitted by the EPA’s Health Effects Division (HED)
states, “Based on

its use pattern there are potential exposures for workers during
application, children or

adult recreational users of treated lakes/streams via swimming, anglers
harvesting fish

after treatment, and dietary exposures from the catfish farm use, and
potential drinking

water exposures from the treatment of lakes/streams/reservoirs that
could be used as a

drinking water source.”iii

The Food Quality Protection Act of 1996 requires that during the
registration process, the

EPA establish a tolerance for pesticides (the level of the pesticide
residue that can be

allowed in food products) based on risk assessment methods to ensure
that the pesticide

can be used with “reasonable certainty of no harm.”iv

However, the HED analysis states, “No tolerance exists for commodities
treated with

antimycin A…HED believes that there are insufficient data at this time
to conduct a

quantitative human health risk assessment for antimycin A. Currently,
HED lacks reliable

information on the hazard of antimycin A with regard to developmental,
reproductive,

neurological, dermal, inhalation and chronic toxicity.”v Additionally,
the Food and Drug

Administration does not test for residues of antimycin A during the
Total Diet Study, a

program that tests for pesticide resides in food.vi

This is unacceptable. The EPA must not allow a food product such as
catfish to be

exposed to a toxic substance without determining the level of residue
that persists in the

edible portion of the fish, and also studying the potential human health
impacts of

consuming the contaminated fish.

Although the level of antimycin A residue in the edible portion of
catfish exposed to the

pisicide has not been studied, it is reasonable to assume the presence
of residue in the

flesh. While catfish can survive comparably higher concentrations of
antimycin A, it can

kill them at concentrations of 20 ppb. In a Bureau of Sport Fisheries
and Wildlife study,

28 out of 30 catfish died in the presence of antimycin A at
concentrations of 20 ppb in the

water.vii

Additionally, a 1966 study, published in Journal of Agricultural and
Food Chemistry,

that measured antimycin A residues in carp and trout provides some basis
for comparison

as to the possible level of antimycin A residue in farmed catfish. Trout
and carp were

exposed to 5 ppb and 10 ppb, levels fatal to both types of fish.viii The
residues in the

edible portions of the fish averaged from 76 to 201 ppm, concentrations
significantly

higher than the 5-10 ppb in the water. The carp, which survived longer
in the presence of

the pisicide, had concentrations of antimycin A residue two to three
times greater than in

the trout.

Since catfish survive longer in the presence of antimycin A at
commercial levels than do

carp, we reasonably conjecture that concentrations of the residue in the
edible portion of

catfish could be even higher than the concentrations in the edible
portion of carp.

Furthermore, another Bureau of Sport Fisheries and Wildlife study
determined that the

effects of antimycin A on fish are likely irreversible, even if the fish
is placed in water

that does not contain any of the pisicide.ix If it is the case that
antimycin A persists in the

flesh of catfish, then the proposed mitigation measure that catfish not
be harvested before

12 months following pisicide application would not do anything to reduce
the risk to

consumers. Pure supposition is not sufficient.

The above studies reinforce the point in the HED analysis about the
potential for dietary

exposure to antimycin A, based on its use in catfish aquaculture.
Indeed, in the face of

such lack of scientific investigation, the EPA cannot conclude that
there is “reasonable

certainty of no harm,” as required by the Food Quality Protection Act.
It is reckless and

unacceptable for the EPA to expose consumers to a chemical whose human
health effects

are simply not known.

EPA Response:

The catfish farm use is considered to be a non-food use because the
Agency intends to require label restrictions not to harvest fish for 1
year following treatment with antimycin A to ensure that fish residues
will be non-detectable.  In addition, antimycin A appears to have a low
potential to bioaccumulate in aquatic organisms (EFED memo, Young and
Steeger 12/12/06, D310730).  Thus, a food tolerance is not necessary
under these use conditions.

The commenter cites a study conducted in 1966 on high concentrations of
antimycin A in fish tissues.  However, the study did not identify the
composition of the residues (i.e., whether they are the parent or
breakdown products).  Also, this study used a tritium label, and our
metabolism guidance (860.1300) states "the use of tritium is strongly
discouraged".  Finally, the EFED chapter states (Page 12…  D. Young
and T. Steeger , 12/12/06, D310730) "Antimycin a…appears to have a low
potential to bioaccumulate in aquatic organisms". Therefore, catfish may
have been present at the time of application, but by the time they are
harvested a year later residues in tissues should have dissipated.

GAME AND FISH DEPARTMENT.  STATE OF ARIZONA.  MARCH 18, 2007.

Comment:

EPA Response:

The HED memorandum has been revised to recommend the following:  “…
additional label language should specify that workers wear long-sleeved
shirt and long pants to preclude dermal exposure during application.
HED also recommends that workers wear coveralls while handling or mixing
the concentrated liquid.”

Comment:

EPA Response:

No revisions are considered necessary to address these comments because
they generally support the HED recommendations.  The Agency will
consider these comments in revising the label language.

 PAGE  11


[Federal Register: October 27, 2009 (Volume 74, Number 206)]
[Notices]
[Page 55285-55286]
[DOCID:fr27oc09-124]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

Petition for Waiver of Compliance

    In accordance with Part 211 of Title 49 Code of Federal Regulations
(CFR), notice is hereby given that the Federal Railroad Administration
(FRA) received a request for a waiver of compliance with certain
requirements of its safety standards. The individual petition is
described below, including the party seeking relief, the regulatory
provisions involved, the nature of the relief being requested, and the
petitioner's arguments in favor of relief.

Michigan State Trust for Railway Preservation, Inc.

[Docket Number FRA-2009-0084]

    The Michigan State Trust For Railway Preservation, Inc.
(Petitioner) seeks a waiver of compliance from certain provisions of
Railroad Freight Car Safety Standards, 49 CFR 215.303, that requires
restricted railroad freight car be stencilled in a specified way.
    The Petitioner is a Michigan Corporation and 501(c)(3) public
charity whose mission is to preserve the nation's steam locomotive
heritage. The Petitioner operates the Steam Railroading Institute, with
the address of P.O. Box 665, Owosso, Michigan 48867-0665.
    The Petitioner owns ten freight cars of various built dates ranging
from December 1923, to January 1957. In a separate request, the
Petitioner is seeking special approval of continued use of these cars
in accordance with 49 CFR 215.203(c). In this petition, the petitioner
stated that the main reason for the petitioner's maintenance and
operation of these historic cars is their status and the attraction as
operating historic artifacts. Stencilling the cars in order to meet the
letter of Section 215.303 would violate the historic impression that
the car is maintained to preserve. The Petitioner further stated that
the operation will be confined to the Great Lakes Central Railroad in
Michigan, at speeds not exceeding 40 miles per hour with light tonnage,
in accordance with Part 215. These cars will never be subject to
interchange.
    Interested parties are invited to participate in these proceedings
by submitting written views, data, or comments. FRA does not anticipate
scheduling a public hearing in connection with these proceedings since
the facts do not appear to warrant a hearing. If any interested party
desires an opportunity for oral comment, they should notify FRA, in
writing, before the end of the comment period and specify the basis for
their request.
    All communications concerning these proceedings should identify the
appropriate docket number (e.g., Waiver Petition Docket Number FRA-
2009-0084) and may be submitted by any of the following methods:
     Web site: http://www.regulations.gov. Follow the online
instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: Docket Operations Facility, U.S. Department of
Transportation, 1200 New Jersey Avenue, SE., W12-140, Washington, DC
20590.
     Hand Delivery: 1200 New Jersey Avenue, SE., Room W12-140,
Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays.
    Communications received within 45 days of the date of this notice
will be considered by FRA before final action is taken. Comments
received after that date will be considered as far as practicable. All
written communications concerning these proceedings are available for
examination during regular business hours (9 a.m.-5 p.m.) at the above
facility. All documents in the public docket are also available for
inspection and copying on the Internet at the docket facility's Web
site at http://www.regulations.gov.
    Anyone is able to search the electronic form of any written
communications and comments received into any of our dockets by the
name of the individual submitting the document (or signing the
document, if submitted on behalf of an association, business, labor
union, etc.). You may review DOT's complete Privacy Act Statement in
the Federal Register published on April 11, 2000 (65 FR

19477) or at http://www.dot.gov/privacy.html.

    Issued in Washington, DC, on October 21, 2009.
Grady C. Cothen, Jr.,
Deputy Associate Administrator for Safety Standards and Program
Development.
[FR Doc. E9-25819 Filed 10-26-09; 8:45 am]

BILLING CODE 4910-06-P


[Federal Register Volume 81, Number 52 (Thursday, March 17, 2016)]
[Notices]
[Pages 14506-14509]
[FR Doc No: 2016-05972]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-77348; File No. SR-NYSEMKT-2016-29]

Self-Regulatory Organizations; NYSE MKT LLC; Notice of Filing and
Immediate Effectiveness of Proposed Rule Change Amending Sections 401
and 402 of the NYSE MKT Company Guide To Harmonize the Exchange's
Immediate Release and Trading Halt Policies

March 11, 2016.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on February 29, 2016, NYSE MKT LLC (the ``Exchange'' or ``NYSE MKT'')
filed with the Securities and Exchange Commission (``SEC'' or
``Commission'') the proposed rule change as described in Items I and II
below, which Items have been prepared by the Exchange. The Commission
is publishing this notice to solicit comments on the proposed rule
change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to amend Sections 401 and 402 of the NYSE MKT
Company Guide (the ``Company Guide'') to harmonize the Exchange's
immediate release and trading halt policies with recent changes made to
the comparable policies of the New York Stock Exchange (``NYSE''). The
proposed rule change is available on the Exchange's Web site at
www.nyse.com, at the principal office of the Exchange, and at the
Commission's Public Reference Room.

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

    In its filing with the Commission, the self-regulatory organization
included statements concerning the purpose of, and basis for, the
proposed rule change

and discussed any comments it received on the proposed rule change. The
text of those statements may be examined at the places specified in
Item IV below. The Exchange has prepared summaries, set forth in
sections A, B, and C below, of the most significant parts of such
statements.

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

1. Purpose
    The Exchange proposes to amend Sections 401 and 402 of the Company
Guide to harmonize the Exchange's immediate release and trading halt
policies with recent changes made to the comparable policies of the
NYSE (referred to herein as the ``NYSE Amendment'').\3\
---------------------------------------------------------------------------

    \3\ See Securities Exchange Release No. 75809 (September 2,
2015); 80 FR 54362 (September 9, 2015) (SR-NYSE-2015-38).
---------------------------------------------------------------------------

    Consistent with the NYSE Amendment, the Exchange proposes to amend
Sections 401 and 402 of the Company Guide to (i) expand the pre-market
hours during which listed companies are required to notify the Exchange
prior to disseminating material news, and (ii) provide the Exchange
with authority to halt trading (a) during pre-market hours at the
request of a listed company, (b) when the Exchange believes it is
necessary to request certain information from listed companies, and (c)
when an Exchange-listed security is also listed on another national or
foreign securities exchange and such other exchange halts trading in
such security for regulatory reasons. The Exchange also proposes to add
commentary to Section 402 of the Company Guide to provide guidance
related to the release of material news after the close of trading on
the Exchange.
    Sections 401 and 402 of the Company Guide give the Exchange
authority to halt trading in a listed company's security under certain
circumstances. Currently, the Exchange may impose a regulatory trading
halt when a listed company announces material news \4\ shortly before
the opening of trading on the Exchange or during the Exchange trading
session (currently 9:30 a.m. to 4:00 p.m.). When that happens, the
Exchange will typically institute a regulatory halt in trading, which
halts trading on all market centers, to ensure full dissemination of
the news to investors. The Exchange proposes to expand the hours and
circumstances under which it can declare a regulatory trading halt.
---------------------------------------------------------------------------

    \4\ The Exchange considers material news to be any news that is
reasonably likely to have a material impact on the price or trading
volume of a listed security.
---------------------------------------------------------------------------

    Currently, Sections 401 and 402 of the Company Guide require listed
companies to notify the Exchange at least ten minutes in advance of
releasing material news if such release will take place shortly before
the opening of trading on the Exchange or during Exchange market hours
(the ``Material News Policy''). The Exchange proposes to amend Sections
401 and 402 to require companies to comply with the Material News
Policy between 7:00 a.m. and 4:00 p.m. Eastern Time. In the Exchange's
experience, most companies release news related to corporate actions
and other material events between 7:00 a.m. and 9:30 a.m. Although
trading on the Exchange does not begin until 9:30 a.m., the Exchange
believes that material news released between 7:00 a.m. and 9:30 a.m.
has the potential to cause volatility in both price and volume during
pre-market trading that occurs on other market centers as well as once
trading opens on the Exchange. However, because there is a lower volume
of trading in such pre-market hours, the Exchange believes that a
listed company is most well positioned to determine whether a trading
halt is appropriate given the news it intends to release. Therefore, to
facilitate an orderly opening and ensure thorough dissemination of
material news, the Exchange believes it is beneficial to require
companies to comply with the Material News Policy and advise whether a
trading halt is appropriate during pre-market hours.
    As discussed above, when a listed company releases material news
during the course of the trading day, the Exchange will typically halt
trading temporarily to ensure full dissemination of the news. Under the
proposed rules, between 7:00 a.m. and the opening of trading on the
Exchange, the Exchange may implement a regulatory halt in circumstances
where (i) the listed company has informed Exchange staff that it
intends to make a public announcement of material news and (ii) the
listed company requests that trading in its listed securities be halted
pending dissemination of the public announcement (a ``Pre-Market
Halt'').\5\ While trading on the Exchange does not begin until 9:30
a.m. Eastern Time, trading (including trading in Exchange listed
securities) begins on NYSE Arca Equities, Inc., the Nasdaq Stock Market
and other national securities exchanges at 4:00 a.m. Eastern Time. When
the Exchange implements a regulatory trading halt to allow for the
release of material news, other national securities exchanges that
trade Exchange-listed securities also halt trading in such security
until the Exchange lifts the halt.\6\
---------------------------------------------------------------------------

    \5\ However, the proposed rule will state that if it appears
that dissemination of material news will not be complete prior to
the opening of trading on the Exchange at 9:30 a.m., the Exchange
may temporarily halt trading in order to facilitate an orderly
opening process. This is consistent with the Exchange's current
practice.
    \6\ See, for example, NYSE Arca Equities Rule 7.18 and Nasdaq
Stock Market Rule 4120(a)(2) for the authority to initiate a trading
halt.
---------------------------------------------------------------------------

    The Exchange notes that the volume of trading in the hours before
trading begins on the Exchange is generally lighter and conducted
predominantly by professional investors. Because of this reduced
trading volume and the fact that the Exchange itself is not yet open
for trading during these hours, the Exchange believes it is appropriate
to institute a Pre-Market Halt only at the request of a listed company.
The Exchange notes that the NYSE Amendment contains a similar provision
and Nasdaq Stock Market (``Nasdaq'') has adopted a comparable rule with
respect to trading halts between the hours of 7:00 a.m. and 9:30
a.m.\7\ Lastly, when a trading halt is implemented during Exchange
market hours, Rule 123D--Equities specifies that a Floor Governor or
two Floor Officials must approve the halt in trading. However, because
a Pre-Market Halt will only be instituted at the request of a listed
company and because Floor Governors and Floor Officials are not
typically on the trading floor during pre-market hours, the Exchange
proposes to include a statement that, notwithstanding anything to the
contrary in Rule 123D(1)--Equities, the approval of the Floor Governors
or Floor Officials is not required for a Pre-Market Halt.
---------------------------------------------------------------------------

    \7\ See Section 202.06(B) of the NYSE Listed Company Manual and
Nasdaq Stock Market Rule 4120(a)(1) (which applies between the hours
of 4:00 a.m. and 9:30 a.m.).
---------------------------------------------------------------------------

    The Exchange proposes to further amend Section 402 of the Company
Guide to add proposed Commentary .02, which will set forth
circumstances in which it may institute a regulatory halt while it
awaits information requested from a listed company. Sections 401 and
402 currently limit the Exchange's authority to halt trading to
situations when a listed company intends to release material news
shortly before and during market hours. However, in the Exchange's
experience there are other scenarios when it may be advisable to halt
trading for the protection of investors. For example, if there is

uncertainty surrounding material news issued by a listed company or a
company's compliance with the Exchange's continued listing standards,
the Exchange believes it may be appropriate to halt trading while it
gathers information to resolve such ambiguity. Accordingly, the
Exchange proposes to add proposed Commentary .02 to Section 402 to
state that if it is necessary to request information from a listed
company relating to (i) material news, (ii) the listed company's
compliance with Exchange continued listing requirements, or (iii) any
other information which is necessary to protect investors and the
public interest, the Exchange may halt trading in such listed company's
security until it has received and evaluated the requested
information.\8\
---------------------------------------------------------------------------

    \8\ The proposed change in this regard mirrors Section 202.06(B)
of the NYSE Listed Company Manual and Nasdaq Stock Market Rule
4120(a)(5).
---------------------------------------------------------------------------

    As discussed above, the Exchange believes that the release of
material news immediately prior to the commencement of trading on the
Exchange has the potential to cause significant volatility to the
opening process. Similarly, material news released immediately after
4:00 p.m. Eastern Time can interfere with the closing process. Although
trading on the Exchange stops at 4:00 p.m. Eastern Time, the order book
for each listed security is manually closed by the security's
Designated Market Maker (``DMM''), a process that can take several
minutes before the closing auction is completed. Because trading
continues after 4:00 p.m. Eastern Time on other exchanges, if a listed
company releases material news immediately after 4:00 p.m. Eastern Time
there can be significant price movement on other markets when compared
to the last sale price on the Exchange. The result, therefore, is that
a DMM can be executing trades at the Exchange closing price while the
same security is simultaneously trading on other exchanges at a very
different price. As this discrepancy can cause confusion to investors,
the Exchange proposes to include advisory text as proposed new
Commentary .03 to Section 402 of the Company Guide requesting that
listed companies intending to release material news after the close of
trading on the Exchange wait until the earlier of the publication of
their security's official closing price on the Exchange or 15 minutes
after the scheduled closing time on the Exchange.\9\ The Exchange
proposes to specify that trading on the Exchange typically closes at
4:00 p.m. Eastern Time, except that on certain days trading closes
early at 1:00 p.m. Eastern Time.
---------------------------------------------------------------------------

    \9\ Although the Exchange typically closes at 4:00 p.m. Eastern
Time, there are certain days each year when it closes at 1:00 p.m.
Eastern Time. The phrase ``15 minutes after the scheduled closing
time'' will account for these early closings.
---------------------------------------------------------------------------

    Lastly, the Exchange proposes to include in proposed Commentary .02
to Section 402 a provision stating that it may halt trading in an
American Depositary Receipt (``ADR'') or other security listed on the
Exchange, when the Exchange-listed security (or the security underlying
the ADR) is listed on or registered with another national securities
exchange or foreign exchange or market and such other exchange (or
regulatory authority overseeing such exchange) halts trading in such
security for regulatory reasons.\10\
---------------------------------------------------------------------------

    \10\ The Exchange notes that the NYSE follows this practice
under Section 202.06(B) of the Listed Company Manual and Nasdaq does
so under Nasdaq Stock Market Rule 4120(a)(4).
---------------------------------------------------------------------------

2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with Section 6(b) \11\ of the Act, in general, and furthers the
objectives of Section 6(b)(5) of the Act,\12\ in particular in that it
is designed to promote just and equitable principles of trade, to
foster cooperation and coordination with persons engaged in regulating,
clearing, settling, processing information with respect to, and
facilitating transactions in securities, 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
and is not designed to permit unfair discrimination between customers,
issuers, brokers, or dealers.
---------------------------------------------------------------------------

    \11\ 15 U.S.C. 78f(b).
    \12\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    The Exchange believes that the proposed amendment is consistent
with the investor protection objectives of section 6(b)(5) because it
gives the Exchange greater flexibility to implement regulatory trading
halts in a listed security when such halts may be necessary for the
protection of investors. Specifically, the proposed rule change will
alter the hours in which listed companies are required to comply with
the Material News Policy such that the hours are from 7:00 a.m. to 4:00
p.m. Eastern Time (rather than just shortly before the opening of
trading on the Exchange and during the Exchange trading session, as is
currently the case). The proposed rule change will also enable the
Exchange to (i) implement a Pre-Market Halt at the request of a listed
company when the company intends to issue material news between 7:00
a.m. and 9.30 a.m. Eastern Time, (ii) halt trading when it believes it
is necessary to request certain information from listed companies, and
(iii) halt trading in an ADR or other Exchange-listed security when the
Exchange-listed security or the security underlying the ADR is listed
on or registered with another national securities exchange or foreign
exchange or market and is halted on such other exchange or market for
regulatory reasons. Additionally, the Exchange proposes to include
advisory text in Section 402 of the Company Guide requesting that
listed companies intending to release material news after the close of
trading on the Exchange wait until the earlier of the publication of
their security's official closing price on the Exchange or 15 minutes
after the scheduled closing time on the Exchange. The Exchange believes
this change will eliminate confusion to investors when a DMM is
executing a trade at the Exchange closing price while the same security
is simultaneously trading on other exchanges at a very different price.
    The Exchange believes that each of the proposed changes enumerated
above is consistent with the investor protection objectives of section
6(b)(5) because they provide the Exchange with additional authority to
halt trading in circumstances where material news that may impact
trading is to be released by listed companies or has not yet been fully
disseminated. The Exchange believes that material news is highly
relevant to investors when deciding to buy or sell securities and thus
providing the Exchange with additional authority to halt trading while
such news is released and disseminated is protective of investors. In
addition, the Exchange believes the proposed rule change is consistent
with the protection of investors because it will specify in Exchange
rules the scenarios in which a trading halt may be necessary, thereby
promoting transparency in Exchange rules and making them easier to
navigate. In giving the Exchange authority to declare regulatory
trading halts in situations described herein, the proposed rule change
enables the Exchange to act in the best interest of protecting
investors.

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

    The Exchange believes that the proposed amendments to Sections 401
and 402 of the Company Guide do not impose any burden on competition
that is not necessary or appropriate in furtherance of the purposes of
the Act. As discussed herein, the Exchange's

proposed amendments to Sections 401 and 402 are designed to give the
Exchange greater flexibility to halt trading in a particular listed
security when the Exchange believes a halt is necessary or appropriate.
Currently, Sections 401 and 402 only permit the Exchange to implement
regulatory trading halts for the dissemination of material news. As
currently drafted, the Exchange believes these rules are unnecessarily
restrictive and do not cover the full spectrum of situations where a
trading halt may be necessary for the protection of investors. In
addition, the Exchange believes that its proposed changes are
consistent with the NYSE and Nasdaq rules with respect to trading
halts. For the foregoing reasons, therefore, the Exchange does not
believe that such changes impose any burden on competition that is not
necessary or appropriate in furtherance of the purposes of the Act.

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

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

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

    Because the foregoing proposed rule change does not: (i)
Significantly affect the protection of investors or the public
interest; (ii) impose any significant burden on competition; and (iii)
become operative prior to 30 days from the date on which it was filed,
or such shorter time as the Commission may designate, it has become
effective pursuant to Section 19(b)(3)(A) of the Act \13\ and Rule 19b-
4(f)(6) \14\ thereunder.
---------------------------------------------------------------------------

    \13\ 15 U.S.C. 78s(b)(3)(A).
    \14\ 17 CFR 240.19b-4(f)(6).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission shall institute proceedings under
Section 19(b)(2)(B) of the Act \15\ to determine whether the proposed
rule change should be approved or disapproved.
---------------------------------------------------------------------------

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

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-NYSEMKT-2016-29 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NYSEMKT-2016-29. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549 on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of the filing also will be available
for inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-NYSEMKT-2016-29, and should
be submitted on or before April 7, 2016.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\16\
---------------------------------------------------------------------------

    \16\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Lynn M. Powalski,
Deputy Secretary.
[FR Doc. 2016-05972 Filed 3-16-16; 8:45 am]
BILLING CODE 8011-01-P