[Federal Register: June 27, 2006 (Volume 71, Number 123)]
[Notices]
[Page 36575-36576]
[DOCID:fr27jn06-75]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-54016; File No. SR-ISE-2006-32]

Self-Regulatory Organizations; International Securities Exchange,
Inc.; Notice of Filing and Immediate Effectiveness of Proposed Rule
Change and Amendment No. 1 Thereto Relating to Fee Changes

June 19, 2006.
    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 1, 2006, the International Securities Exchange, Inc. (ISE or
Exchange) filed with the Securities and Exchange Commission
(Commission) the proposed rule change as described in Items I, II, and
III below, which Items have been prepared by the ISE. On June 15, 2006,
ISE filed Amendment No. 1 to the proposed rule change.\3\ The ISE has
designated this proposal as one establishing or changing a due, fee, or
other charge imposed by the ISE under Section 19(b)(3)(A)(ii) of the
Act,\4\ and Rule 19b-4(f)(2) thereunder,\5\ which renders the proposal
effective upon filing with the Commission. The Commission is publishing
this notice to solicit comments on the proposed rule change, as
amended, from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ Amendment No. 1 deleted brackets included in the initial
Exhibit 5. The brackets reflected a proposed rule change in SR-ISE-
2006-30, which was originally submitted under Section 19(b)(3)(A) of
the Act, rejected by the Commission, and subsequently re-filed by
the Exchange under Section 19(b)(2) of the Act. The Exchange also
made clarifying changes to the purpose section of the filing. The
correction to Exhibit 5 and the clarifications to the purpose
section of the original filing do not affect the fees covered by
this filing.
    \4\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \5\ 17 CFR 240.19b-4(f)(2).
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The ISE is proposing to increase the threshold average daily volume
(ADV) levels for the reduction and waiver of execution fees and the
waiver of comparison fees with respect to trading options on the Nasdaq
100 Index Tracking Stock[reg] (QQQQ) and transactions executed in the
Exchange's Facilitation Mechanism.
    The text of the proposed rule change, as amended, is available on
the ISE's Web site (http://www.iseoptions.com/legal/proposed_rule_changes.asp
), at the principal office of the ISE, 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 ISE 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 ISE has prepared summaries, set forth in Sections A,
B, and C below, of the most significant aspects of such statements.

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

1. Purpose
    The purpose of this proposed rule change is to increase the
threshold ADV levels for the reduction and waiver of execution fees and
the waiver of comparison fees in the Exchange's Schedule of Fees for
(i) trading options in the QQQQ and (ii) transactions executed through
the Exchange's Facilitation Mechanism. In November 2003, on a pilot
basis, the Exchange adopted a reduction and a waiver of execution fees
and a waiver of comparison fees for QQQQ options.\6\ In September 2004,
again on a pilot basis, the Exchange adopted a similar reduction and a
waiver of execution fees and a waiver of comparison fees on
transactions executed through the Exchange's Facilitation Mechanism.\7\
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    \6\ See Securities Exchange Act Release No. 49147 (January 29,
2004), 69 FR 5629 (February 5, 2004). See also Securities Exchange
Act Release Nos. 49853 (June 14, 2004), 69 FR 35087 (June 23, 2004)
(extending the pilot program until November 30, 2004); 50900
(December 21, 2004), 69 FR 78075 (December 29, 2004) (extending the
pilot program until November 30, 2005); and 52934 (December 9,
2005), 70 FR 74859 (December 16, 2005) (extending the pilot program
until November 30, 2006).
    \7\ See Securities Exchange Act Release Nos. 50658 (November 12,
2004), 69 FR 67768 (November 19, 2004); and 52934, supra note 6
(extending the pilot program until November 30, 2006). The
Facilitation Mechanism is a process by which Electronic Access
Members facilitate block-size orders. Options traded in the
Facilitation Mechanism are treated as Firm Proprietary orders and,
as such, are subject to an execution and comparison fee of $0.15 and
$0.03 per contract per side, respectively.
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Discount on QQQQ Execution and Comparison Fees
    Under the current QQQQ pilot program, when a member's monthly ADV
in QQQQ options reaches 8,000 contracts, the member's execution fee for
the next 2,000 contracts is reduced by $0.10 per contract.\8\ Further,
when a member's monthly ADV in QQQQ options reaches 10,000 contracts,
the Exchange waives the entire execution fee and the comparison fee for
each QQQQ option contract traded thereafter. The Exchange states that
its volume in QQQQ options traded has increased as a result of this
pilot program. As a result, ISE now proposes to increase the threshold
ADV levels at which the fee reduction and waiver for QQQQ options
traded apply, such that the $0.10 per contract fee reduction shall
apply for the next 2,000 contracts when a member's monthly ADV in QQQQ
options reaches 10,000 contracts. Further, when a member's monthly ADV
reaches 12,000 contracts, the Exchange will waive the entire execution
fee and the comparison fee for each QQQQ option contract traded
thereafter.
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    \8\ This execution fee and any reduction or waiver thereof is
applicable to Firm Proprietary orders and ISE Market Maker orders.
For ISE Market Maker orders, the execution fee is currently between
$0.21 and $0.12 per contract side, depending on the Exchange Average
Daily Volume, and the comparison fee is currently $0.03 per contract
per side.
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Discount on Facilitation Mechanism Fees
    With respect to the Exchange's Facilitation Mechanism, the
structure of

the reduction and waiver of the execution fee for the Facilitation
Mechanism (``facilitation execution fee'') and the waiver of the
comparison fee are similar to the structure of the reduction and waiver
of the QQQQ execution fee and the waiver of the comparison fee noted
above. That is, when a member's monthly ADV in the Facilitation
Mechanism reached 8,000 contracts, the member's facilitation execution
fee for the next 2,000 contracts transacted in the Facilitation
Mechanism is reduced by $0.10 per contract.\9\ Further, when a member's
monthly ADV in the Facilitation Mechanism reaches 10,000 contracts, the
Exchange waives the entire facilitation execution fee and the
comparison fee for each contract transacted in the Facilitation
Mechanism thereafter. The Exchange believes that the current pilot
program has also encouraged members to use the Facilitation Mechanism,
illustrated by its increased volume. As such, the Exchange now also
proposes to increase the threshold ADV levels at which the fee
reduction and waiver for options traded in the Facilitation Mechanism
apply, such that the $0.10 per contract fee reduction shall apply for
the next 5,000 contracts when a member's monthly ADV in the
Facilitation Mechanism reaches 15,000 contracts. Further, when a
member's monthly ADV reaches 20,000 contracts, the Exchange will waive
the entire execution fee and the comparison fee for each option
contract traded in the Facilitation Mechanism thereafter.
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    \9\ This execution fee and any reduction or waiver thereof is
applicable only to Firm Proprietary orders. See supra note 7.
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    The Exchange believes that the proposed increases of the threshold
levels will allow it to maintain its competitiveness in trading QQQQ
options and encourage continued use by members of the Facilitation
Mechanism.
2. Statutory Basis
    The Exchange believes that the proposed rule change, as amended, is
consistent with Section 6(b)(4) of the Act,\10\ which requires that an
exchange have an equitable allocation of reasonable dues, fees, and
other charges among its members and other persons using its facilities.
In particular, these fees would extend current reductions and waivers.
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    \10\ 15 U.S.C. 78f(b)(4).
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B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange believes that the proposed rule change does not 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

    The Exchange has not solicited, and does not intend to solicit,
comments on this proposed rule change. The Exchange has not received
any unsolicited written comments from members or other interested
parties.

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A) of the Act \11\ and Rule 19b-4(f)(2) \12\ thereunder
because it changes a fee imposed by the Exchange. At any time within 60
days of the filing of such amended proposed rule change, the Commission
may summarily abrogate such rule change if it appears to the Commission
that such action is necessary or appropriate in the public interest,
for the protection of investors, or otherwise in furtherance of the
purposes of the Act.\13\
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    \11\ 15 U.S.C. 78s(b)(3)(A).
    \12\ 17 CFR 19b-4(f)(2).
    \13\ The effective date of the original proposed rule is June 1,
2006. The effective date of Amendment No. 1 is June 15, 2006. For
purposes of calculating the 60-day period within which the
Commission may summarily abrograte the proposed rule change under
Section 19(b)(3)(C) of the Act, the Commission considers the period
to commence on June 15, 2006, the date on which the ISE submitted
Amendment No. 1 See 15 U.S.C. 78s(b)(3)(C).
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IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment from (http://www.sec.gov/rules/sro.shtml.
); or     Send an e-mail to<EMAIL_ADDRESS>Please include

File No. SR-ISE-2006-32 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-ISE-2006-32. This file
number should be included on the subject line if e-mail 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: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 inspection and copying in the
Commission's Public Reference Room. Copies of such filings also will be
available for inspection and copying at the principal office of the
ISE. 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-ISE-
2006-32 and should be submitted on or before July 18, 2006.
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    \14\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\14\
J. Lynn Taylor,
Assistant Secretary.
[FR Doc. 06-5677 Filed 6-26-06; 8:45 am]

BILLING CODE 8010-01-M


[Federal Register Volume 79, Number 246 (Tuesday, December 23, 2014)]
[Notices]
[Page 77075]
[FR Doc No: 2014-29968]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-73856; File No. SR-MIAX-2014-30]

Self-Regulatory Organizations; Miami International Securities
Exchange LLC; Notice of Designation of a Longer Period for Commission
Action on Proceedings To Determine Whether To Approve or Disapprove a
Proposed Rule Change To List and Trade Options on Shares of the iShares
ETFs

December 17, 2014.
    On June 17, 2014, Miami International Securities Exchange LLC
(``MIAX'' or ``Exchange'') filed with the Securities and Exchange
Commission (``Commission''), pursuant to Section 19(b)(1) of the
Securities Exchange Act of 1934 (``Exchange Act'' or ``Act'') \1\ and
Rule 19b-4 thereunder,\2\ a proposed rule change to list and trade
options on shares of the iShares MSCI Brazil Capped ETF, iShares MSCI
Chile Capped ETF, iShares MSCI Peru Capped ETF, and iShares MSCI Spain
Capped ETF (collectively ``iShares ETFs''). The proposed rule change
was published for comment in the Federal Register on July 3, 2014.\3\
On August 13, 2014, the Commission extended the time period in which to
either approve the proposed rule change, disapprove the proposed rule
change, or institute proceedings to determine whether to approve or
disapprove the proposed rule change, to October 1, 2014.\4\ On
September 25, 2014, the Commission instituted proceedings to determine
whether to approve or disapprove the proposed rule change.\5\ The
Commission received a letter from MIAX on the proposal.\6\
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 72492 (June 27,
2014), 79 FR 38099 (SR-MIAX-2014-30) (``iShares ETFs Proposal'').
    \4\ See Securities Exchange Act Release No. 72835 (August 13,
2014), 79 FR 49140 (August 19, 2014).
    \5\ See Securities Exchange Act Release No. 73211 (September 25,
2014), 79 FR 59338 (October 1, 2014).
    \6\ See Letter to Elizabeth M. Murphy, Secretary, Commission,
from Brian O'Neill, Vice President and Senior Counsel, MIAX, dated
October 22, 2014 (providing comment on SR-MIAX-2014-30 and SR-MIAX-
2014-39) (``MIAX Letter'').
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    Section 19(b)(2) of the Act \7\ provides that, after initiating
disapproval proceedings, the Commission shall issue an order approving
or disapproving the proposed rule change not later than 180 days after
the date of publication of notice of filing of the proposed rule
change. The Commission may extend the period for issuing an order
approving or disapproving the proposed rule change, however, by not
more than 60 days if the Commission determines that a longer period is
appropriate and publishes the reasons for such determination. In this
case, the proposed rule change was published for notice and comment in
the Federal Register on July 3, 2014. December 30, 2014, is 180 days
from that date, and February 28, 2015, is 240 days from that date.
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    \7\ 15 U.S.C. 78s(b)(2).
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    The Commission finds it appropriate to designate a longer period
within which to issue an order approving or disapproving the proposed
rule change so that it has sufficient time to evaluate the proposed
rule change and whether it is consistent with the Act.\8\ The proposed
rule change would allow the Exchange to list for trading on the
Exchange options on shares of the iShares ETFs without satisfying the
Exchange's listing standards, which require, in part, that the
component securities of an index or portfolio of securities on which
the Exchange Traded Fund Shares are based for which the primary market
is in any one country that is not subject to a comprehensive
surveillance sharing agreement do not represent 20% or more of the
weight of the index.\9\
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    \8\ The Commission notes that MIAX also submitted a similar
proposed rule change to list and trade options on shares of certain
Market Vectors ETFs. See Securities Exchange Act Release No. 72777
(August 6, 2014), 79 FR 47165 (August 12, 2014) (MIAX-2014-39).
    \9\ See MIAX Rule 402(i)(5)(ii)(B). The Exchange represents that
each of the iShares ETFs are comprised of component securities for
which the primary market is a single foreign market, and that, for
each ETF, MIAX does not have a CSSA with its foreign counterpart in
the applicable foreign market.
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    Accordingly, the Commission, pursuant to Section 19(b)(2) of the
Act,\10\ designates February 28, 2015, as the date by which the
Commission shall either approve or disapprove the proposed rule change
(File No. SR-MIAX-2014-30).
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    \10\ Id.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\11\
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    \11\ 17 CFR 200.30-3(a)(57).
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Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2014-29968 Filed 12-22-14; 8:45 am]
BILLING CODE 8011-01-P


MEMORANDUM

DATE:		April 23, 2015
TO:		Clean Power Plan for Existing Power Plants; Docket Id: OAR - 2013-0602
FROM:		Angela Hackel, OAQPS
SUBJECT:	April 23, 2015 Meeting with Environmental Groups
--------------------------------------------------------------------------------

SUMMARY
This meeting was held to discuss a number of rulemakings being conducted within the Office of Air Quality Planning and Standards. One of the rulemakings discussed was the Clean Power Plan.
ATTENDEES
EPA
   * Steve Page, OAQPS
   * Mike Koerber, OAQPS
   * Peter Tsirigotis, OAQPS

External
   * David Baron, Earthjustice
   * Paul Cort, Earthjustice
   * John Walke, Natural Resources Defense Council
   * Emily Davis, Natural Resources Defense Council
   * Peter Zalzal, Environmental Defense Fund
   * Janice Nolen, American Lung Association
   * Zachary Fabish, Sierra Club


[Federal Register Volume 78, Number 10 (Tuesday, January 15, 2013)]
[Notices]
[Pages 3065-3067]
[FR Doc No: 2013-00610]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-68606; File No. SR-CBOE-2012-131]

Self-Regulatory Organizations; Chicago Board Options Exchange,
Incorporated; Notice of Filing and Immediate Effectiveness of a
Proposed Rule Change Amending Rule 5.5.04 To Permit the Exchange To
List Additional Strike Prices Until the Close of Trading on the Second
Business Day Prior to Monthly Expiration in Unusual Market Conditions

January 9, 2013.
    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 December 28, 2012, the Chicago Board Options Exchange,
Incorporated (the ``Exchange'' or ``CBOE'') filed with the Securities
and Exchange Commission (the ``Commission'') the proposed rule change
as described in Items I and II below, which Items have been prepared by
the Exchange. The Exchange filed the proposal as a ``non-
controversial'' proposed rule change pursuant to Section
19(b)(3)(A)(iii) of the Act \3\ and Rule 19b-4(f)(6) thereunder,\4\
which renders the proposal effective upon filing with the Commission.
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.
    \3\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \4\ 17 CFR 240.19b-4(f)(6).
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    CBOE proposes to amend Interpretation and Policy .04 to CBOE Rule
5.5 to permit the Exchange to list additional strike prices until the
close of trading on the second business day prior to the expiration of
a monthly, or standard, option in the event of unusual market
conditions. The text of the proposed rule change is available on the
Exchange's Web site (http://www.cboe.org/legal), at the Exchange's
Office of the Secretary, 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 purpose of this filing is to amend Interpretation and Policy
.04 to CBOE Rule 5.5 to permit the Exchange to add additional strikes
until the close of trading on the second business day prior to a
monthly expiration in the event of unusual market conditions.
    This is a competitive filing that is based on two recently approved
filings submitted by NYSE MKT LLC (``NYSE MKT'') and NYSE, Arca, Inc.
(``NYSE Arca'').\5\ The NYSE MKT and NYSE Arca filings both made
changes to their respective rules governing the last day on which
strikes may be added for individual stock and exchange-traded fund
(``ETF'') options. Similar to CBOE Rule 5.5.04, NYSE MKT and NYSE Arca
had rules that permitted the opening of additional series of individual
stock and ETF options until the first calendar day of the month in
which the option expires or until the fifth business day prior to
expiration if unusual market conditions exist. NYSE MKT and NYSE Arca
both amended their rules to permit the opening of additional series of
individual stocks and ETF options until the close of trading on the
second business day prior to the expiration of a monthly, or standard,
option in the event of unusual market conditions.
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    \5\ See Securities Exchange Act Release Nos. 68460 (December 18,
2012), (SR-NYSEMKT-2012-41) (approval order) (``NYSE MKT filing'')
and 68461 (December 18, 2012) (SR-NYSEArca-2012-94) (approval order)
(``NYSE Arca filing'').
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    Options market participants generally prefer to focus their trading
in strike prices that immediately surround the price of the underlying
security. However, if the price of the underlying stock or ETF moves
significantly, there

may be a market need for additional strike prices to adequately account
for market participants' risk management needs in a stock or ETF. In
these situations, the Exchange has the ability to add additional series
at strike prices that are better tailored to the risk management needs
of market participants. The Exchange may make the determination to open
additional series for trading when the Exchange deems it necessary to
maintain an orderly market, to meet customer demand, or when the market
price of the underlying stock or ETF moves more than five strike prices
from the initial exercise price or prices.\6\
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    \6\ See CBOE Rule 5.5(c).
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    If the market need occurs prior to five business days prior to
expiration, then the market participants may have access to an option
contract that is more tailored to the movement in the underlying stock
or ETF. Under current CBOE Rule 5.5.04, however, the Exchange is unable
to open additional series in response to unusual market conditions that
occur between five to two days prior to expiration and market
participants may be left without a contract that is tailored to manage
their risk. Because of the current five-days-before expiration
restriction, investors may be unable to tailor their hedging activities
in options and effectively manage their risk going into expiration.
    The Exchange proposes to permit the listing of additional strikes
until the close of trading on the second business day prior to
expiration in unusual market conditions. Since expiration of standard
options on individual stocks and ETFs is on a Saturday, the close of
trading on the second business day prior to expiration will typically
fall on a Thursday. However, in the cases where Friday is a holiday
during which the Exchange is closed, the close of trading on the second
business day will occur on a Wednesday. The Exchange will continue to
make the determination to open additional series for trading when the
Exchange deems it necessary to maintain an orderly market, to meet
customer demand, or when certain price movements take place in the
underlying market. The proposed change will provide an additional four
days to the Exchange to gauge market impact of the underlying stock or
ETF and to react to any market conditions that would render additional
series prior to expiration beneficial to market participants. The
Exchange believes that the impact on the market from the proposed
change will be very minimal to market participants; however, it will be
extremely beneficial when unusual market conditions occur during the
five to two days leading up to expiration. As a result, the proposal
would allow participants to adjust their risk exposure when an unusual
market event occurred on trading days 2, 3, 4, 5 prior to expiration.
    This proposal does not raise any capacity concerns on the Exchange,
because the changes have no material difference in impact from the
current rules. The Exchange notes the proposed change allows for new
strikes that would otherwise be permitted to add under existing rules
either on the fifth day prior or immediately after expiration.\7\ A
strike which opens two days prior to expiration will have minimal
impact on quoting, as it adds two series out of hundreds of thousands,
and only for a small number of days.\8\ Thus, any additional strikes
that may be added under the proposed change would have no measurable
effect on systems capacity.
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    \7\ Any new strikes added under this proposal would be added in
a manner consistent with the range limitations described in CBOE
Rule 5.5A.
    \8\ In the case of a multi-stock event where multiple stocks may
be subject to unusual market conditions, a strike which opens two
days prior to expiration will also have minimal impact on quoting,
as it adds two series per stock out of hundreds of thousands, and
only for a small number of days.
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    The Exchange understands that The Options Clearing Corporation
(``OCC'') is able to accommodate the proposal and would have no
operational concerns with adding new series on any day except the last
day of trading an expiring series.
2. Statutory Basis
    The Exchange believes the proposed rule change is consistent with
the Act and the rules and regulations thereunder, including the
requirements of Section 6(b) of the Act.\9\ In particular, the Exchange
believes the proposed rule change is consistent with the Section
6(b)(5) \10\ requirements that the rules of an exchange be designed to
promote just and equitable principles of trade, to prevent fraudulent
and manipulative acts, to foster cooperation and coordination with
persons engaged in facilitating transactions in securities, to remove
impediments to and to perfect the mechanism for a free and open market
and a national market system, and, in general, to protect investors and
the public interest.
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    \9\ 15 U.S.C. 78f(b).
    \10\ 15 U.S.C. 78f(b)(5).
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    The Exchange believes that providing an additional four days to the
Exchange to gauge market impact and to react to any market conditions
prior to expiration is beneficial and will result in a continuing
benefit to investors by giving them more flexibility to closely tailor
their investment decisions and hedging decisions prior to expiration.
The Exchange also believes that the additional four days will provide
the investing public and other market participants with additional
opportunities to hedge their investment thus allowing these investors
to better manage their risk exposure with additional in the money
series. While the four additional days may generate additional quote
traffic, the Exchange does not believe that this increased traffic will
become unmanageable since the proposal remains limited to the narrow
situations when an unusual market event occurred on trading days 2, 3,
4, 5 prior to expiration. The Exchange also believes that the proposed
rule change will ensure competition because CBOE will be able to list
additional equity and ETF series up the second day before expiration in
the same manner that NYSE MKT and NYSE Arca are currently able to do.

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

    This proposed rule change does not impose any burden on competition
that is not necessary or appropriate in furtherance of the purposes of
the Act. In this regard and as indicated above, the Exchange notes that
the rule change is being proposed as a competitive response to recently
approved NYSE MKT and NYSE Arca. CBOE believes this proposed rule
change is necessary to permit fair competition among the options
exchanges.

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 does not (i) Significantly
affect the protection of investors or the public interest; (ii) impose
any significant burden on competition; and (iii) become operative for
30 days from the date on which it was filed, or such shorter time as
the Commission may designate if consistent with the protection of
investors and the public interest, provided that the self-regulatory
organization has given the Commission written notice of its intent to
file the proposed rule change at least five business days prior to the
date of filing

of the proposed rule change or such shorter time as designated by the
Commission, the proposed rule change has become effective pursuant to
Section 19(b)(3)(A) of the Act \11\ and Rule 19b-4(f)(6)
thereunder.\12\
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    \11\ 15 U.S.C. 78s(b)(3)(A).
    \12\ 17 CFR 240.19b-4(f)(6).
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    The Exchange has requested that the Commission waive the 30-day
operative delay. The Commission believes that waiver of the operative
delay is consistent with the protection of investors and the public
interest because the proposal is substantially similar to those of
other exchanges that have been approved by the Commission and would
allow CBOE, also, to add additional strikes until the close of trading
on the second business day prior to a monthly expiration in the event
of unusual market conditions.\13\ Therefore, the Commission designates
the proposal operative upon filing.\14\
---------------------------------------------------------------------------

    \13\ See supra, note 5.
    \14\ For purposes only of waiving the 30-day operative delay,
the Commission has considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
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    At any time within 60 days of the filing of such proposed rule
change, the Commission may summarily abrogate such rule change if it
appears to the Commission that such action is necessary or appropriate
in the public interest, for the protection of investors, or otherwise
in furtherance of the purposes of the Act.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-CBOE-2012-131 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-CBOE-2012-131. 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 also will be available
for inspection and copying at the principal office of the CBOE. 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-CBOE-2012-131 and should be
submitted on or before February 5, 2013.
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    \15\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\15\
Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2013-00610 Filed 1-14-13; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 76, Number 197 (Wednesday, October 12, 2011)]
[Notices]
[Page 63333]
[FR Doc No: 2011-26513]

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SECURITIES AND EXCHANGE COMMISSION

Sunshine Act Meeting

    Notice is hereby given, pursuant to the provisions of the
Government in the Sunshine Act, Public Law 94-409, that the Securities
and Exchange Commission will hold a Roundtable on Execution, Clearance
and Settlement of Microcap Securities on Monday, October 17, 2011,
commencing at 1 p.m.
    This Sunshine Act notice is being issued because a majority of the
Commission may attend the meeting.
    The Roundtable will take place in the Multi-Purpose Room of the
Commission's headquarters at 100 F Street, NE., Washington DC. The
Roundtable will be open to the public with seating on a first-come,
first-served basis. Doors will open at 12:30 p.m. Visitors will be
subject to security checks.
    The Roundtable will consist of a series of three panels. Panelists
will consider a range of microcap securities topics, such as the
current issues facing small cap issuers in the clearance and settlement
process, potential regulatory changes impacting the Over-The-Counter
markets, and Anti-Money laundering concerns specific to microcap
issuers.
    For further information, please contact the Office of the Secretary
at<PHONE_NUMBER>.

     October 7, 2011.
Elizabeth M. Murphy,
Secretary.
[FR Doc. 2011-26513 Filed 10-7-11; 4:15 pm]
BILLING CODE 8011-01-P


PAPERWORK REDUCTION ACT SUBMISSION Please read the instructions before completing this form. For additional forms or assistance in completing this form, contact your agency's Paperwork Clearance Officer. Send two copies of this form, the collection instrument to be reviewed, the Supporting Statement and any additional documentation to: Office of Information and Regulatory Affairs, Office of Management and Budget, Docket Library, Room 10102, 725 17th Street NW Washington, DC 20503.

1. Agency/ Subagency originating request USEPA/ Office of Enforcement and Compliance Assurance/ Office of Compliance 2. OMB control number b. G None a. 2060 0029 __ __ __ __

3. Type of information collection ( check one) a. G New collection b. G Revision of a currently approved collection c. X Extension of a currently approved collection d. G Reinstatement, without change, of a previously approved collection for which approval has expired e. G Reinstatement, with change, of a previously approved collection for which approval has expired f. G Existing collection in use without an OMB control number 4. Type of review requested ( check one) a. X Regular b. G Emergency  Approval requested by: / / c. G Delegated 5. Small entities Will this information collection have a significant economic impact on a substantial number of small entities? G Yes X No For b f, note item A2 of Supporting Statement Instructions 6. Requested expiration date a. X Three years from approval date b. G Other Specify: / /___

7. Title NSPS for Primary and Secondary Emissions from Basic Oxygen Furnaces ( 40 CFR part 60, subparts N and Na) ( Renewal)

8. Agency form number( s) ( If applicable) ICR Number 1069.08 9. Keywords Basic oxygen furnaces, basic oxygen process furnace shops ( BOPF) shops, steel plants, iron and steel plants and NSPS.

10. Abstract These rules apply to BOPFs in iron and steel plants commencing construction, modification or reconstruction after June 11, 1973 ( NSPS Subpart N) and to top blown BOPFs, hot metal transfer stations or skimming stations for which construction, reconstruction, or modification commenced after January 20, 1983 ( NSPS Subpart Na). Consistent with the NSPS General Provisions ( 40 CFR part 60, subpart A), owners and operators subject to these rules are required to comply with recordkeeping, monitoring and reporting requirements, unless specified otherwise in the regulation. The monitoring requirements specific to BOPF shops provide information the the operation of the emissions control device and compliance with the mass and visible emission standards. Sources are required to submit semiannual reports of measurements that average 10 percent below the average measurements obtained during the most recent performance tests and maintain records of their operations for two years.

11. Affected public ( Mark primary with " P" and all others that apply with " X") a. Individuals or households d. Farms b. P Business or other for profit e. Federal Government c. Not for profit institutions f. State, Local or Tribal Government 12. Obligation to respond ( Mark primary with " P" and all others that apply with " X") a. G Voluntary b. G Required to obtain or retain benefits c. P Mandatory 13. Annual reporting and recordkeeping hour burden a. Number of respondents 5 b. Total annual responses 12 1. Percentage of these responses collected electronically 10 % c. Total hours requested 1,896 d. Current OMB inventory 1,012 e. Difference 884 f. Explanation of difference 1. Program Change 0 2. Adjustment 884 14. Annual reporting and recordkeeping cost burden ( in thousands of dollars) a. Total annualized capital/ startup costs 18 b. Total annual costs ( O& M) 8 c. Total annualized cost requested 26 d. Current OMB inventory 26 e. Difference 0 f. Explanation of difference 1. Program change 0 2. Adjustment 0 15. Purpose of information collection ( Mark Primary With " P" and all others that apply with " X") a. Application for benefits e. Program planning or management b. Program evaluation f. Research c. General purpose statistics g. P Regulatory or compliance d. __ Audit 16. Frequency of recordkeeping or reporting ( check all that apply) a. X Recordkeeping b. Q Third party disclosure c. X Reporting 1. X On occasion 2. Q Weekly 3. Q Monthly 4. Q Quarterly 5. X Semi annually 6. Q Annually 7. Q Biannually 8. X Other ( describe) Initially 17. Statistical methods Does this information collection employ statistical methods?

Q Yes X No 18. Agency contact ( person who can best answer questions regarding the content of this submission) Name: Maria Malave Phone: ( 202) 564 7027 OMB 83 I 10/ 95 19. Certification for Paperwork Reduction Act Submissions On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with' 5 CFR 1320.9.

NOTE: The text of 5 CFR 1320.9, and the related provisions of 5 CFR 1320.8( b)( 3), appear at the end of the instructions. The certification is to be made with reference to those regulatory provisions as set forth in the instructions.

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

( a) It is necessary for the proper performance of agency functions;

( b) It avoids unnecessary duplication;

( c) It reduces burden on small entities;

( d) It uses plain, coherent, and unambiguous terminology that is understandable to respondents;

( e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

( f) It indicates the retention periods for recordkeeping requirements;

( g) It informs respondents of the information called for under 5 CFR 1320.8( b)( 3):

( i) Why the information is being collected; ( ii) Use of information; ( iii) Burden estimate; ( iv) Nature of response ( voluntary, required for a benefit, or mandatory); ( v) Nature and extent of confidentiality; and ( vi) Need to display currently valid OMB control number;

( h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected ( see note in Item 19 of the instructions);

( i) It uses effective and efficient statistical survey methodology; and ( j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item below and explain the reason in Item 18 of the Supporting Statement. Signature of Program Official Michael S. Alushin, Director Compliance Assessment and Media Programs Division Office of Compliance Office of Enforcement and Compliance Assurance Date Signature of Senior Official or designee Oscar Morales, Director Collection Strategies Division Office of Environmental Information Date OMB 83 I 10/ 95 Certification Requirement for Paperwork Reduction Act Submissions 5 CFR 1320.9 reads " As part of the agency submission to OMB of a proposed collection of information, the agency ( through the head of the agency, the Senior Official or their designee) shall certify ( and provide a record supporting such certification) that the proposed collection of information

"( a) is necessary for the proper performance of the functions of the agency, including that the information to be collected will have practical utility;

"( b) is not unnecessarily duplicative of information otherwise reasonably accessible to the agency;

"( c) reduces to the extent practicable and appropriate the burden on persons who shall provide information to or for the agency, including with respect to small entities, as defined in the Regulatory Flexibility Act 5 U. S. C. § 601( 6)), the use of such techniques as:

"( 1) establishing differing compliance or reporting requirements or timetables that take into account the resources available to those who are to respond; "( 2) the clarification, consolidation, or simplification of compliance and reporting requirements; or collection of information , or any part thereof; "( 3) an exemption from coverage of the collection of information, or any part thereof;

"( d) is written using plain, coherent, and unambiguous terminology and is understandable to those who are to respond;

"( e) is to be implemented in ways consistent and compatible, to the maximum extent practicable, with the existing reporting and recordkeeping practices of those who are to respond;

"( f) indicates for each recordkeeping requirement the length of time persons are required to maintain the records specified;

"( g) informs potential respondents of the information called for under § 1320.8( b)( 3); [ see below]

"( h) has been developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected, including the processing of the information in a manner which shall enhance, where appropriate, the utility of the information to agencies and the public;

"( i) uses effective and efficient statistical survey methodology appropriate to the purpose for which the information is to be collected; and "( j) to the maximum extent practicable, uses appropriate information technology to reduce burden and improve data quality, agency efficiency and responsiveness to the public."

NOTE: 5 CFR 1320.8( b)( 3) requires that each collection of information:

"( 3) informs and provides reasonable notice to the potential persons to whom the collection of information is addressed of:

"( i) the reasons the information is planned to be and/ or has been used to further the proper performance of the functions of the agency; "( ii) the way such information is planned to be and/ or has been used to further the proper performance of the functions of the agency; "( iii) an estimate, to the extent practicable, of the average burden of the collection ( together with a request that the public direct to the agency any comments concerning the accuracy of this burden estimate and any suggestions for reducing this burden); "( iv) whether responses to the collection of information are voluntary, required to obtain or retain a benefit ( citing authority), or mandatory ( citing authority); "( v) the nature and extent of confidentiality to be provided, if any ( citing authority); and "( vi) the fact that any agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number." OMB 83 I ( Instructions) 10/ 95


[Federal Register Volume 83, Number 156 (Monday, August 13, 2018)]
[Notices]
[Pages 40059-40070]
[FR Doc No: 2018-17303]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-3009]

Authorization of Emergency Use of a Freeze Dried Plasma Treatment
for Hemorrhage or Coagulopathy During an Emergency Involving Agents of
Military Combat; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
issuance of an Emergency Use Authorization (EUA) (the Authorization)
for a freeze dried plasma treatment for hemorrhage or coagulopathy
during an emergency involving agents of military combat (e.g.,
firearms, projectiles, and explosive devices) when plasma is not
available for use or when the use of plasma is not practical. FDA
issued this Authorization under the Federal Food, Drug, and Cosmetic
Act (FD&C Act), as requested by the U.S. Department of Defense (DoD).
The Authorization contains, among other things, conditions on the
emergency use of the authorized treatment. The Authorization follows
the June 7, 2018, determination by the Deputy Secretary of Defense that
there is a military emergency or significant potential for a military
emergency, involving a heightened risk to U.S. military forces of an
attack with an agent or agents that may cause, or are otherwise
associated with an imminently life-threatening and specific risk to
those forces. The Deputy Secretary of Defense further stated that, more
specifically, U.S. forces are now deployed in multiple locations where
they serve at heightened risk of an enemy attack with agents of
military combat, including firearms, projectiles, and explosive
devices, that may cause major and imminently life-threatening combat
casualties involving uncontrolled hemorrhage. On the basis of such
determination, the Department of Health and Human Services (HHS)
Secretary declared on July 9, 2018, that circumstances exist justifying
the authorization of emergency use of freeze dried plasma for the
treatment of hemorrhage or coagulopathy during an emergency involving
agents of military combat (e.g., firearms, projectiles, and explosive
devices) when plasma is not available for use or when the use of plasma
is not practical, subject to the terms of any authorization issued
under the FD&C Act. The Authorization, which includes an explanation of
the reasons for issuance, is reprinted in this document.

DATES: The Authorization is effective as of July 9, 2018.

ADDRESSES: Submit written requests for single copies of the EUA to the
Office of Counterterrorism and Emerging Threats, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4338, Silver
Spring, MD 20993-0002. Send one self-addressed adhesive label to assist
that office in processing your request or include a fax number to which
the Authorization may be sent. See the SUPPLEMENTARY INFORMATION
section for electronic access to the Authorization.

FOR FURTHER INFORMATION CONTACT: Michael Mair, Office of
Counterterrorism and Emerging Threats, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 1, Rm. 4340, Silver Spring, MD 20993-
0002,<PHONE_NUMBER> (this is not a toll-free number).

SUPPLEMENTARY INFORMATION:

I. Background

    Section 564 of the FD&C Act (21 U.S.C. 360bbb-3) as amended by the
Project BioShield Act of 2004 (Pub. L. 108-276), the Pandemic and All-
Hazards Preparedness Reauthorization Act of 2013 (Pub. L. 113-5), 21st
Century Cures Act (Pub. L. 114-255), and Public Law 115-92 (2017),
allows FDA to strengthen the public health protections against
biological, chemical, nuclear, and radiological agents and other agents
that may cause, or are otherwise associated with, an imminently life-
threatening and specific risk to U.S. military forces. Among other
things, section 564 of the FD&C Act allows FDA to authorize the use of
an unapproved medical product or an unapproved use of an approved
medical product in certain situations. With this EUA authority, FDA can
help assure that medical countermeasures may be used in emergencies to
diagnose, treat, or prevent serious or life-threatening diseases or
conditions caused by biological, chemical, nuclear, or radiological
agents and other agents that may cause, or are otherwise associated
with, an imminently life-threatening and specific risk to U.S. military
forces when there are no adequate, approved, and available
alternatives.
    Section 564(b)(1) of the FD&C Act provides that, before an EUA may
be issued, the Secretary of HHS must declare that circumstances exist
justifying the authorization based on one of the following grounds: (1)
A determination by the Secretary of Homeland Security that there is a
domestic emergency, or a significant potential for a domestic
emergency, involving a heightened risk of attack with a biological,
chemical, radiological, or nuclear agent or agents; (2) a determination
by the Secretary of Defense that there is a military emergency, or a
significant potential for a military emergency, involving a heightened
risk to U.S. military forces, including personnel operating under the
authority of title 10 or title 50, United States Code, of attack with
(i) a biological, chemical, radiological, or nuclear agent or agents;
or (ii) an agent or agents that may cause, or are otherwise associated
with, an imminently life-threatening and specific risk to U.S. military
forces; \1\ (3) a determination by the Secretary of HHS that there is a
public health emergency, or a significant potential for a public health
emergency, that affects, or has a significant potential to affect,
national security or the health and security of U.S. citizens living
abroad, and that involves a biological, chemical, radiological, or
nuclear agent or agents, or a disease or condition that may be
attributable to such agent or agents; or (4) the identification of a
material threat by the Secretary of Homeland Security under section
319F-2 of the Public Health Service (PHS) Act (42 U.S.C. 247d-6b)
sufficient to affect national security or the health and security of
U.S. citizens living abroad.
---------------------------------------------------------------------------

    \1\ In the case of a determination by the Secretary of Defense,
the Secretary of HHS shall determine, within 45 calendar days of
such determination, whether to make a declaration under section
564(b)(1) of the FD&C Act, and, if appropriate, shall promptly make
such a declaration.
---------------------------------------------------------------------------

    Once the Secretary of HHS has declared that circumstances exist
justifying an authorization under section 564 of the FD&C Act, FDA may
authorize the emergency use of a drug, device, or biological product if
the Agency concludes that the statutory criteria are satisfied. Under
section

564(h)(1) of the FD&C Act, FDA is required to publish in the Federal
Register a notice of each authorization, and each termination or
revocation of an authorization, and an explanation of the reasons for
the action. Section 564 of the FD&C Act permits FDA to authorize the
introduction into interstate commerce of a drug, device, or biological
product intended for use when the Secretary of HHS has declared that
circumstances exist justifying the authorization of emergency use.
Products appropriate for emergency use may include products and uses
that are not approved, cleared, or licensed under sections 505, 510(k),
512, or 515 of the FD&C Act (21 U.S.C. 355, 360(k), 360b, and 360e) or
section 351 of the PHS Act (42 U.S.C. 262), or conditionally approved
under section 571 of the FD&C Act (21 U.S.C. 360ccc). FDA may issue an
EUA only if, after consultation with the HHS Assistant Secretary for
Preparedness and Response, the Director of the National Institutes of
Health, and the Director of the Centers for Disease Control and
Prevention (to the extent feasible and appropriate given the applicable
circumstances), FDA \2\ concludes: (1) That an agent referred to in a
declaration of emergency or threat can cause a serious or life-
threatening disease or condition; (2) that, based on the totality of
scientific evidence available to FDA, including data from adequate and
well-controlled clinical trials, if available, it is reasonable to
believe that: (A) The product may be effective in diagnosing, treating,
or preventing (i) such disease or condition; or (ii) a serious or life-
threatening disease or condition caused by a product authorized under
section 564, approved or cleared under the FD&C Act, or licensed under
section 351 of the PHS Act, for diagnosing, treating, or preventing
such a disease or condition caused by such an agent; and (B) the known
and potential benefits of the product, when used to diagnose, prevent,
or treat such disease or condition, outweigh the known and potential
risks of the product, taking into consideration the material threat
posed by the agent or agents identified in a declaration under section
564(b)(1)(D) of the FD&C Act, if applicable; (3) that there is no
adequate, approved, and available alternative to the product for
diagnosing, preventing, or treating such disease or condition; (4) in
the case of a determination described in section 564(b)(1)(B)(ii), that
the request for emergency use is made by the Secretary of Defense; and
(5) that such other criteria as may be prescribed by regulation are
satisfied.
---------------------------------------------------------------------------

    \2\ The Secretary of HHS has delegated the authority to issue an
EUA under section 564 of the FD&C Act to the Commissioner of Food
and Drugs.
---------------------------------------------------------------------------

    No other criteria for issuance have been prescribed by regulation
under section 564(c)(4) of the FD&C Act. Because the statute is self-
executing, regulations or guidance are not required for FDA to
implement the EUA authority.

II. EUA Request for a Freeze Dried Plasma Treatment for Hemorrhage or
Coagulopathy During an Emergency Involving Agents of Military Combat
When Plasma Is Not Available for Use or When the Use of Plasma Is Not
Practical

    On June 7, 2018, the Deputy Secretary of Defense determined that
``there is a military emergency or significant potential for a military
emergency, involving a heightened risk to U.S. military forces of an
attack with an agent or agents that may cause, or are otherwise
associated with an imminently life-threatening and specific risk to
those forces.'' The Deputy Secretary of Defense further stated that,
``[m]ore specifically, U.S. [f]orces are now deployed in multiple
locations where they serve at heightened risk of an enemy attack with
agents of military combat, including firearms, projectiles, and
explosive devices, that may cause major and imminently life-threatening
combat casualties involving uncontrolled hemorrhage.'' On July 9, 2018,
under section 564(b)(1) of the FD&C Act, and on the basis of such
determination, the Secretary of HHS declared that circumstances exist
justifying the authorization of emergency use of freeze dried plasma
for the treatment of hemorrhage or coagulopathy during an emergency
involving agents of military combat (e.g., firearms, projectiles, and
explosive devices) when plasma is not available for use or when the use
of plasma is not practical, subject to the terms of any authorization
issued under section 564 of the FD&C Act. Notice of the declaration of
the Secretary of HHS was published in the Federal Register on July 16,
2018 (83 FR 32884) and a correction was published in the Federal
Register on July 31, 2018 (83 FR 36941). On July 9, 2018, DoD
requested, and on July 9, 2018, FDA issued, an EUA for Pathogen-Reduced
Leukocyte-Depleted Freeze Dried Plasma manufactured by the Centre de
Transfusion Sanguine des Arm[eacute]es (CTSA) (for purposes of this
EUA, ``French FDP''), subject to the terms of the Authorization.

III. Electronic Access

    An electronic version of this document and the full text of the
Authorization are available on the internet at https://www.regulations.gov.

IV. The Authorization

    Having concluded that the criteria for issuance of the
Authorization under section 564(c) of the FD&C Act are met, FDA has
authorized the emergency use of a freeze dried plasma treatment for the
treatment of hemorrhage or coagulopathy during an emergency involving
agents of military combat (e.g., firearms, projectiles, and explosive
devices) when plasma is not available for use or when the use of plasma
is not practical, subject to the terms of the Authorization. The
Authorization in its entirety (not including the authorized versions of
the fact sheets and other written materials) follows and provides an
explanation of the reasons for issuance, as required by section
564(h)(1) of the FD&C Act.

 BILLING CODE 4164-01-P

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    Dated: August 7, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-17303 Filed 8-10-18; 8:45 am]
 BILLING CODE 4164-01-C