[Federal Register Volume 79, Number 122 (Wednesday, June 25, 2014)]
[Notices]
[Pages 36110-36112]
[FR Doc No: 2014-14779]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-72434; File No. SR-BATS-2014-014; SR-BX-2014-021; SR-
BYX-2014-007; SR-CHX-2014-06; SR-EDGA-2014-11; SR-EDGX-2014-12; SR-
FINRA-2014-021; SR-ISE-2014-25; SR-NASDAQ-2014-044; SR-NSX-2014-08; SR-
NYSE-2014-22; SR-NYSEArca-2014-48; SR-NYSEMKT-2014-37; SR-Phlx-2014-27]

Self-Regulatory Organizations; BATS Exchange, Inc.; BATS-Y
Exchange, Inc.; NASDAQ OMX BX, Inc.; Chicago Stock Exchange, Inc.; EDGA
Exchange, Inc.; EDGX Exchange, Inc.; Financial Industry Regulatory
Authority, Inc.; International Securities Exchange LLC; The NASDAQ
Stock Market LLC; National Stock Exchange, Inc.; New York Stock
Exchange LLC; NYSE Arca, Inc.; NYSE MKT LLC; NASDAQ OMX PHLX LLC; Order
Granting Approval of Proposed Rule Changes Relating to Clearly
Erroneous Executions

June 19, 2014.

I. Introduction

    On April 17, 2014, BATS Exchange, Inc. (``BATS''), BATS-Y Exchange,
Inc. (``BATS-Y''), NASDAQ OMX BX, Inc. (``BX''), EDGA Exchange, Inc.
(``EDGA''), EDGX Exchange, Inc. (``EDGX''), Financial Industry
Regulatory Authority, Inc. (``FINRA''), International Securities
Exchange LLC (``ISE''), The NASDAQ Stock Market LLC (``Nasdaq''),
National Stock Exchange, Inc. (``NSX''), and NASDAQ OMX PHLX LLC
(``Phlx'') filed with the Securities and Exchange Commission
(``Commission'') pursuant to Section 19(b)(1) of the Securities
Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4 thereunder,\2\
proposed rule changes to amend certain of their respective rules
relating to clearly erroneous transactions. On April 21, 2014, New York
Stock Exchange LLC (``NYSE''), NYSE Arca, Inc. (``NYSE Arca'') and NYSE
MKT LLC (``NYSE MKT'') filed with the Commission pursuant to Section
19(b)(1) of the Securities Exchange Act of 1934 (``Act'') \3\ and Rule
19b-4 thereunder,\4\ proposed rule changes to amend certain of their
respective rules relating to clearly erroneous transactions. On April
22, 2014, Chicago Stock Exchange, Inc. (``CHX'') filed with the
Commission pursuant to Section 19(b)(1) of the Securities Exchange Act
of 1934 (``Act'') \5\ and Rule 19b-4 thereunder,\6\ proposed rule
changes to amend certain of its respective rules relating to clearly
erroneous transactions. The proposed rule changes were published for
comment in the Federal Register on May 6, 2014.\7\ The Commission
received no comments on the proposed changes. This order approves the
proposed rule changes.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(1).
    \4\ 17 CFR 240.19b-4.
    \5\ 15 U.S.C. 78s(b)(1).
    \6\ 17 CFR 240.19b-4.
    \7\ See Securities Exchange Act Release Nos. 72044 (April 30,
2014), 79 FR 25919; 72045 (April 30, 2014), 79 FR 25943; 72046
(April 30, 2014), 79 FR 25972; 72047 (April 30, 2014), 79 FR 25940;
72048 (April 30, 2014), 79 FR 25976; 72049 (April 30, 2014), 79 FR
25951; 72050 (April 30, 2014), 79 FR 25933; 72051 (April 30, 2014),
79 FR 25954; 72052 (April 30, 2014), 79 FR 25958; 72053 (April 30,
2014), 79 FR 25965; 72054 (April 30, 2014), 79 FR 25947; 72055
(April 30, 2014), 79 FR 25961; 72056 (April 30, 2014), 79 FR 25968;
and 72057 (April 30, 2014), 79 FR 25937 (collectively, the
``Notices'').
---------------------------------------------------------------------------

II. Description of the Proposal

A. Background

    The U.S. equity markets experienced a severe disruption on May 6,
2010.\8\ Severe price volatility led to a large number of trades being
executed at temporarily depressed prices, including many that occurred
at prices dramatically away from pre-decline levels. BATS, BX, CHX,
EDGA, EDGX, ISE, Nasdaq, NSX, NYSE, NYSE Arca, NYSE MKT (collectively,
and, together with BATS-Y and Phlx, the ``Exchanges'') and FINRA
(collectively, the ``self-regulatory organizations'' or the ``SROs'')
exercised their authority under their clearly erroneous executions
rules to break trades that were effected at prices 60% or more away
from pre-decline prices, using a process that was not sufficiently
clear or transparent to market participants. To clarify the clearly
erroneous execution review process across all SROs, and reduce the
discretion of the Exchanges and FINRA to deviate from the objective
standards in their respective rules when dealing with clearly erroneous
transactions, the Exchanges and FINRA filed proposed rule changes to,
among other things, establish clear thresholds for when

trades should be broken and to limit the discretion to deviate from
specified percentage thresholds at which trades would be broken in many
situations, including those where the single-stock circuit breakers are
applicable and in other larger ``Multi-Stock Events'' involving five or
more securities.\9\ These proposed rule changes were approved on a
pilot basis by the Commission.\10\
---------------------------------------------------------------------------

    \8\ The events of May 6, 2010 are described more fully in the
report of the staffs of the Commodity Futures Trading Commission
(``CFTC'') and the Commission, titled Report of the CFTC and SEC to
the Joint Advisory Committee on Emerging Regulatory Issues,
``Preliminary Findings Regarding the Market Events of May 6, 2010,''
dated May 18, 2010.
    \9\ See Securities Exchange Act Release Nos. 62330 (June 21,
2010), 75 FR 36725 (June 28, 2010); 62331 (June 21, 2010), 75 FR
36746 (June 28, 2010); 62332 (June 21, 2010), 75 FR 36749 (June 28,
2010); 62333 (June 21, 2010), 75 FR 36759 (June 28, 2010); 62334
(June 21, 2010), 75 FR 36732 (June 28, 2010); 62335 (June 21, 2010),
75 FR 37494 (June 29, 2010); 62336 (June 21, 2010), 75 FR 36743
(June 28, 2010); 62337 (June 21, 2010), 75 FR 36739 (June 28, 2010);
62338 (June 21, 2010), 75 FR 36762 (June 28, 2010); 62339 (June 21,
2010), 75 FR 36765 (June 28, 2010); 62340 (June 21, 2010), 75 FR
36768 (June 28, 2010); 62341 (June 21, 2010), 75 FR 36756 (June 28,
2010); and 62342 (June 21, 2010), 75 FR 36752 (June 28, 2010).
    \10\ See Securities Exchange Act Release Nos. 62885 (September
10, 2010), 75 FR 56641 (September 16, 2010); 62886 (September 10,
2010), 75 FR 56613 (September 16, 2010).
---------------------------------------------------------------------------

    In January 2013, the Exchanges and FINRA adopted a provision in
their clearly erroneous executions rules designed to address the
operation of the Plan to Address Extraordinary Market Volatility
Pursuant to Rule 608 of Regulation NMS under the Act (the ``Limit Up-
Limit Down Plan'').\11\ Subsequently, the Exchanges and FINRA removed
the specific provisions in the clearly erroneous executions rules
related to individual stock trading pauses,\12\ and recently extended
the pilot program to coincide with the pilot period for the Limit Up-
Limit Down Plan, including any extensions to the pilot period for the
Limit Up-Limit Down Plan.\13\
---------------------------------------------------------------------------

    \11\ See Securities Exchange Release Nos. 68797 (January 31,
2013), 78 FR 8635 (February 6, 2013); 68798 (January 31, 2013), 78
FR 8628 (February 6, 2013); 68801 (February 1, 2013), 78 FR 8630
(February 6, 2013); 68802 (February 1, 2013), 78 FR 9092 (February
7, 2013); 68803 (February 1, 2013), 78 FR 9078 (February 7, 2013);
68804 (February 1, 2013), 78 FR 8677 (February 6, 2013); 68808
(February 1, 2013), 78 FR 9083 (February 7, 2013); 68809 (February
1, 2013), 78 FR 9081 (February 7, 2013); 68813 (February 1, 2013),
78 FR 9073 (February 7, 2013); 68814 (February 1, 2013), 78 FR 9086
(February 7, 2013); 68818 (February 1, 2013), 78 FR 9100 (February
7, 2013); 68819 (February 1, 2013), 78 FR 9438 (February 8, 2013);
68820 (February 1, 2013), 78 FR 9436 (February 8, 2013); and 68822
(February 4, 2013), 78 FR 9440 (February 8, 2013).
    \12\ See Securities Exchange Act Release Nos. 70510 (September
26, 2013), 78 FR 60991 (October 2, 2013); 70511 (September 26,
2013), 78 FR 60941 (October 2, 2013); 70512 (September 26, 2013), 78
FR 60965 (October 2, 2013); 70513 (September 26, 2013), 78 FR 60973
(October 2, 2013); 70514 (September 26, 2013), 78 FR 60963 (October
2, 2013); 70515 (September 26, 2013), 78 FR 60945 (October 2, 2013);
70516 (September 26, 2013), 78 FR 60952 (October 2, 2013); 70517
(September 26, 2013), 78 FR 60943 (October 2, 2013); 70518
(September 26, 2013), 78 FR 60950 (October 2, 2013); 70519
(September 26, 2013), 78 FR 60969 (October 2, 2013); 70529
(September 26, 2013), 78 FR 60977 (October 2, 2013); 70541
(September 27, 2013), 78 FR 61431 (October 3, 2013); 70542
(September 27, 2013), 78 FR 61427 (October 3, 2013); and 70589
(October 1, 2013), 78 FR 62782 (October 22, 2013).
    \13\ See Securities Exchange Act Release Nos. 71781 (March 24,
2014), 79 FR 17615 (March 28, 2014); 71782 (March 24, 2014), 79 FR
17630 (March 28, 2014); 71783 (March 24, 2014), 79 FR 17617 (March
28, 2014); 71784 (March 24, 2014), 79 FR 17610 (March 28, 2014);
71785 (March 24, 2014), 79 FR 17621 (March 28, 2014); 71795 (March
25, 2014), 79 FR 18089 (March 31, 2014); 71796 (March 25, 2014), 79
FR 18099 (March 31, 2014); 71797 (March 25, 2014), 79 FR 18108
(March 31, 2014); 71806 (March 26, 2014), 79 FR 18375 (April 1,
2014); 71807 (March 26, 2014), 79 FR 18087 (March 31, 2014); 71808
(March 26, 2014), 79 FR 18355 (April 1, 2014); 71809 (March 26,
2014), 79 FR 18353 (April 1, 2014); 71820 (March 27, 2014), 79 FR
18595 (April 2, 2014); and 71821 (March 27, 2014), 79 FR 18592
(April 2, 2014).
---------------------------------------------------------------------------

B. The Proposed Rule Changes

    The Exchanges and FINRA now propose to adopt two new provisions in
their respective clearly erroneous executions rules, as discussed
below. Additionally, the SROs propose to update certain cross-
references in their clearly erroneous executions rules to reflect the
addition of the new proposed rules. The proposals of each of the
Exchanges and FINRA are substantially similar.\14\
---------------------------------------------------------------------------

    \14\ While certain Exchanges only propose to permit an Exchange
officer to declare transactions null and void for purposes of the
proposed rules, BATS, BATS-Y, CHX, EDGA, EDGX, ISE, NSX and Phlx
each propose to permit a senior level designee to act as an officer
for purposes of the proposed rules and FINRA proposes to permit the
executive vice president of its Market Regulation Department or
Transparency Service Department or any officer designated by such
executive vice president to act as a FINRA officer for purposes of
the proposed rules. In addition, FINRA proposes to make additional
changes to its rule addressing clearly erroneous transactions in
exchange-listed securities, including replacing ``market centers''
and ``markets'' with ``other self-regulatory organizations'' to
categorize the Exchanges and FINRA in the same manner (as self-
regulatory organizations); and other technical or clarifying
changes.
---------------------------------------------------------------------------

1. Multi-Day Event Based on Fundamentally Incorrect or Grossly
Misinterpreted Issuance Information
    The Exchanges and FINRA propose to adopt a new paragraph in their
respective clearly erroneous executions rules that would provide that a
series of transactions in a particular security on one or more trading
days may be viewed as one event if all such transactions were effected
based on the same fundamentally incorrect or grossly misinterpreted
issuance information (e.g., with respect to a stock split or corporate
dividend) resulting in a severe valuation error for all such
transactions (the ``Multi-Day Event'').\15\
---------------------------------------------------------------------------

    \15\ As an example of a Multi-Day Event contemplated by the
proposed paragraph, the Notices refer to a specific event involving
an exchange offer made by U.S. Bancorp on the NYSE in 2010, in which
depositary shares of U.S. Bancorp traded over the course of a period
of days at a price approximately one-tenth the actual value of the
security (the ``U.S. Bancorp Event''). The NYSE filed an emergency
rule filing to nullify all trades occurring after the exchange offer
at severely dislocated prices. See Notices, supra note 7 (describing
Securities Exchange Act Release No. 62609 (July 30, 2010), 75 FR
47327 (August 5, 2010)).
---------------------------------------------------------------------------

    The Exchanges and FINRA propose that an officer of an Exchange or
FINRA, or a senior level employee designee (as applicable)
(collectively, ``Officer''), acting on his or her own motion, shall
take action to declare all transactions that occurred during the Multi-
Day Event null and void not later than the start of trading on the day
following the last transaction in the Multi-Day Event. If trading in
the security is halted before the valuation error is corrected, the
Officer shall take action to declare all transactions that occurred
during the Multi-Day Event null and void prior to the resumption of
trading. However, no action would be permitted pursuant to the proposed
paragraph with respect to any transactions that have reached the
settlement date for the security or that result from an initial public
offering (``IPO'') of a security.
    Further, the Exchanges and FINRA propose that to the extent
transactions related to a Multi-Day Event involve one or more other
SROs, the affected SROs would be required to promptly coordinate with
each other to ensure consistent treatment of the transactions related
to the Multi-Day Event, if practicable. The Exchanges and FINRA also
propose that any action taken in connection with the proposed paragraph
would be required to be taken without regard to the numerical
guidelines set forth in the clearly erroneous executions rules of each
Exchange and FINRA.\16\
---------------------------------------------------------------------------

    \16\ See e.g., BATS Rule 11.17(c)(3); Nasdaq Rule
11890(a)(2)(C)(1); FINRA Rule 11892(b)(1). For example, an Officer
would have the authority to nullify transactions resulting from a
stock split that were based on fundamentally incorrect or grossly
misinterpreted issuance information, even if such transactions were
effected at prices consistent with the price at which the security
was previously trading. The transactions in this particular example
would not meet the applicable numerical guidelines, but would be
considered clearly erroneous for purposes of the proposed paragraph
because they should have been effected at prices well away from the
actual execution prices.
---------------------------------------------------------------------------

    The Exchanges and FINRA also propose to include a provision stating
that each party involved in a transaction subject to the proposed
paragraph would be required to be notified as soon as practicable of a
determination to declare such transaction null and void, and that the
party aggrieved by such action may appeal in accordance with the
applicable appeals provision of each

Exchange or FINRA's clearly erroneous executions rules.\17\
---------------------------------------------------------------------------

    \17\ See e.g., BATS Rule 11.17(e)(2); Nasdaq Rule 11890(c);
FINRA Rule 11894.
---------------------------------------------------------------------------

2. Trading Halts
    The Exchanges and FINRA also propose to adopt an additional
paragraph in their respective clearly erroneous executions rules
relating to transactions resulting from certain disruptions or
malfunctions in connection with a regulatory trading halt, suspension
or pause (``trading halt'') in a security. Specifically, in the event
of any disruption or malfunction in the operation of the electronic
communications and trading facilities of an Exchange, another SRO, or
responsible single plan processor in connection with the transmittal or
receipt of a trading halt, an Officer, acting on his or her own motion,
shall nullify any transaction that occurs after a trading halt has been
declared by the primary listing market for a security and before such
trading halt has officially ended according to the primary listing
market. In addition, the Exchanges and FINRA propose that, in the event
a trading halt is declared, then prematurely lifted in error, and then
re-instituted, an Officer, acting on his or her own motion shall
nullify transactions that occur before the official, final end of the
trading halt according to the primary listing market. In the event that
a trading halt is declared as of a future time, the Exchanges and FINRA
would nullify only those transactions occurring after the time the
trading halt was supposed to be in place until the official end of the
trading halt according to the primary listing market.
    The Exchanges and FINRA propose that any action taken in connection
with the proposed paragraph would be taken in a timely fashion,
generally within thirty minutes of the detection of the erroneous
transaction and in no circumstances later than the start of regular
market hours, generally between 9:30 a.m. EST to 4:00 p.m. EST, on the
trading day following the date of execution(s) under review. The
Exchanges and FINRA also propose that any action taken in connection
with the proposed rule would be required to be taken without regard to
the numerical guidelines set forth in their respective clearly
erroneous executions rules \18\ because such transactions should not
have occurred during a trading halt, and thus, nullifying them, or
declaring them null and void would not put the parties in a different
position. Lastly, the Exchanges and FINRA also propose to include a
provision stating that each party involved in a transaction subject to
the proposed paragraph would be required to be notified as soon as
practicable of a determination to nullify such transaction, and that
the party aggrieved by such action may appeal in accordance with the
applicable appeals provision of each Exchange or FINRA's clearly
erroneous executions rules.\19\
---------------------------------------------------------------------------

    \18\ See supra note 16.
    \19\ See supra note 17.
---------------------------------------------------------------------------

III. Discussion and Commission Findings

    After careful review, the Commission finds that the proposed rule
changes are consistent with the requirements of the Act and the rules
and regulations thereunder applicable to national securities exchanges
and national securities associations.\20\ In particular, the Commission
finds that the proposed rule changes submitted by the Exchanges and
FINRA are consistent with the requirements of Section 6(b)(5) of the
Act \21\ (in the case of the Exchanges) and Section 15A(b)(6) of the
Act \22\ (in the case of FINRA) which require, among other things, that
the rules of national securities exchanges and FINRA, respectively,
must be designed to prevent fraudulent and manipulative acts and
practices, to promote just and equitable principles of trade, 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.
---------------------------------------------------------------------------

    \20\ In approving this proposed rule change, the Commission has
considered the proposed rule's impact on efficiency, competition,
and capital formation. See 15 U.S.C. 78c(f).
    \21\ 15 U.S.C. 78f(b)(5).
    \22\ 15 U.S.C. 78o-3(b)(6).
---------------------------------------------------------------------------

    In the Commission's view, the proposed rule changes will continue
to help assure that the determination of whether a clearly erroneous
trade has occurred will be based on clear and objective criteria, and
that the resolution of the incident will occur promptly through a
transparent process. The proposed rule changes also should help
continue to assure consistent results in handling erroneous trades
across the U.S. markets, thus furthering fair and orderly markets and
the protection of investors and the public interest. Specifically, the
Commission believes that the provision relating to the handling of
Multi-Day Events effected based on the same fundamentally incorrect or
grossly misinterpreted issuance information that results in a severe
valuation error should contribute to a more transparent process, and
help achieve a fair and equitable result, on the very rare occasions
such events occur. The Commission believes that the proposed trading
halt provision should help to increase certainty and transparency with
respect to transactions that inadvertently occur during trading halts
due to a technology failure. The Commission notes that these
transactions should not have occurred in the first place, and that the
proposed rule change provides certainty to market participants that
these transactions will be nullified promptly through an objective and
transparent process.

IV. Conclusion

    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\23\ that the proposed rule changes, SR-BATS-2014-014; SR-BX-2014-
021; SR-BYX-2014-007; SR-CHX-2014-06; SR-EDGA-2014-11; SR-EDGX-2014-12;
SR-FINRA-2014-021; SR-ISE-2014-25; SR-NASDAQ-2014-044; SR-NSX-2014-08;
SR-NYSE-2014-22; SR-NYSEArca-2014-48; SR-NYSEMKT-2014-37; SR-Phlx-2014-
27, be, and hereby are, approved.
---------------------------------------------------------------------------

    \23\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\24\
---------------------------------------------------------------------------

    \24\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2014-14779 Filed 6-24-14; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: March 15, 2011 (Volume 76, Number 50)]
[Notices]
[Page 14027-14028]
[DOCID:fr15mr11-85]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0002]

Antiviral Drugs Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

    This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will
be open to the public.
    Name of Committee: Antiviral Drugs Advisory Committee.
    General Function of the Committee: To provide advice and
recommendations to the Agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on April 28, 2011, from 8
a.m. to 5 p.m.
    Location: FDA White Oak Campus, 10903 New Hampshire Ave., Building
31 Conference Center, the Great Room (rm. 1503), Silver Spring, MD
20993-0002. Information regarding special accommodations due to a
disability, visitor parking and transportation may be accessed at:
http://www.fda.gov/AdvisoryCommittees/default.htm; under the heading
``Resources for You'', click on ``White Oak Conference Center Parking
and Transportation Information for FDA Advisory Committee Meetings.''
Please note that visitors to the White Oak Campus must enter through
Building 1.
    Contact Person: Paul Tran, Center for Drug Evaluation and Research,
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, rm.
2417, Silver Spring, MD 20993-0002,<PHONE_NUMBER>, Fax:<PHONE_NUMBER>, e-
mail<EMAIL_ADDRESS>or FDA Advisory Committee Information
Line, 1-800-741-8138<PHONE_NUMBER> in the Washington, DC area), and
follow the prompts to the desired center or product area. Please call
the Information Line for up-to-date information on this meeting. A
notice in the Federal Register about last minute modifications that
impact a previously announced advisory committee meeting cannot always
be published quickly enough to provide timely notice. Therefore, you
should always check the Agency's Web site and call the appropriate
advisory committee hot line/phone line to learn about possible
modifications before coming to the meeting.
    Agenda: On April 28, 2011, the committee will discuss a new drug
application (NDA) 201-917, telaprevir (a hepatitis C virus protease
inhibitor), manufactured by Vertex Pharmaceuticals, Inc., with a
proposed indication for the treatment of chronic hepatitis C genotype 1
infection, in combination with peginterferon alfa and ribavirin (two
medicines approved to treat chronic hepatitis C infection) in adult
patients with compensated liver disease who are previously untreated or
who have failed previous therapy. Compensated liver disease is a stage
in which the liver is damaged but maintains ability to function.
    FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its Web site prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's Web site after the meeting. Background material is
available at http://www.fda.gov/AdvisoryCommittees/Calendar/
default.htm. Scroll down to the appropriate advisory committee link.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person on or before
April 14, 2011. Oral presentations from the public will be scheduled
between approximately 1 p.m. and 2 p.m. Those individuals interested in
making formal oral presentations should notify the contact person and
submit a brief statement of the general nature of the evidence or
arguments they wish to present, the names and addresses of proposed
participants, and an indication of the approximate time requested to
make their presentation on or before April 6, 2011. Time allotted for
each presentation may be limited. If the number of registrants
requesting to speak is greater than can be reasonably accommodated
during the scheduled open public hearing session, FDA may conduct a
lottery to determine the speakers for the scheduled open public hearing
session. The contact person will notify interested persons regarding
their request to speak by April 7, 2011.
    Persons attending FDA's advisory committee meetings are advised
that the Agency is not responsible for providing access to electrical
outlets.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
physical disabilities or special needs. If you require special
accommodations due to

a disability, please contact Paul Tran at least 7 days in advance of
the meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at http://www.fda.gov/
AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: March 9, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-5901 Filed 3-14-11; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register: March 11, 2010 (Volume 75, Number 47)]
[Notices]
[Page 11604-11605]
[DOCID:fr11mr10-100]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-61646; File No. SR-NYSE-2010-03]

Self-Regulatory Organizations; New York Stock Exchange LLC; Order
Approving Proposed Rule Change Amending the Rule Governing the Issuance
of Trading Licenses

March 4, 2010.

I. Introduction

    On January 13, 2010, New York Stock Exchange LLC (``NYSE'' or the
``Exchange'') filed with the Securities and Exchange Commission (the
``Commission''), pursuant to Section 19(b)(1) \1\ of the Securities
Exchange Act of 1934 (the ``Act'') \2\ and Rule 19b-4 thereunder,\3\ a
proposal to amend its Rule 300 (Trading Licenses) and Rule 309 (Failure
to Pay Exchange Fees). The proposed rule change was published for
comment in the Federal Register on February 2, 2010.\4\ The Commission
received no comments regarding the proposal. This order approves the
proposed rule change.
---------------------------------------------------------------------------

    \1\ 15 U.S.C.78s(b)(1).
    \2\ 15 U.S.C. 78a.
    \3\ 17 CFR 240.19b-4.
    \4\ See Securities Exchange Act Release No. 61424 (January 26,
2010), 75 FR 5367.
---------------------------------------------------------------------------

II. Description of the Proposal

    NYSE Rule 300 provides that member organizations may buy trading
licenses in the annual offering and may buy licenses at any other time
in the year, provided that the maximum number of 1,366 licenses has not
been issued and subject to limitations on the number of licenses a
single member organization may hold. Member organizations must pay for
their trading licenses in 12 monthly installments, with the first
installment due prior to the commencement of the applicable year. The
Exchange represents that it relies in part on the revenues from trading
license fees to pay for the maintenance of the trading floor and to
fund its trading floor regulatory activities. According to the
Exchange, if some member organizations consistently fail to pay their
trading license fee bills, the Exchange would be forced to impose
higher fees on those member organizations which do pay their bills.
    The Exchange therefore proposes to amend Rule 300 to provide that a
member organization shall be ineligible to purchase a trading license,
either in the annual offering or subsequently, if, at the time of such
proposed purchase, such member organization remains three months in
arrears in paying monthly installments of the trading license fee
payable in respect of any previously purchased trading license.\5\ Any
trading license purchased by a member organization in the annual
auction for the calendar year commencing January 1, 2010, will be
subject to automatic revocation at the close of business on March 31,
2010, if the member organization that holds such license remains three
months in arrears in making such payments at that time.
---------------------------------------------------------------------------

    \5\ The Exchange also proposes to amend Rule 309 to explicitly
provide that failure to pay trading license fee installments will be
governed by proposed Rule 300(h).
---------------------------------------------------------------------------

    The Exchange also proposes to adopt appeal procedures for the
denial or revocation of a member organization's trading license. One
calendar month prior to the effective date of any potential denial of
renewal or revocation of a trading license (the ``Expiration Date'')
pursuant to Rule 300(h), the Exchange would notify each applicable
member organization that is currently two months or more in arrears in
paying monthly installments of the trading license fee payable in
respect of any previously purchased trading license of the amount of
then overdue trading license installment payments and the possibility
of denial of renewal or revocation of the trading license on the
Expiration Date. The notice must include a description of the appeal
process. If the member organization believes the Exchange's records are
incorrect, the member organization must submit a written appeal within
five business days of receipt of the Exchange's notice to the officer
of the Exchange identified for that purpose in such notice, providing
an explanation as to why it believes the Exchange's records are
incorrect, and providing copies of any relevant documentation. The
Exchange would be required to provide a final determination in writing
in response to any such appeal no later than 15 calendar days prior to
the effective date of the potential denial of renewal or revocation of
the applicable trading license.\6\ If the Exchange denies the appeal,
its written final determination must specifically address the arguments
made by the member organization in its submission. The Exchange's
written determination would be final and conclusive action by the
Exchange.
---------------------------------------------------------------------------

    \6\ The Exchange represents that, if it denies a member
organization's appeal under Rule 300(h), the Exchange will notify
the Commission in the manner required by Exchange Act Rule 19d-1.
---------------------------------------------------------------------------

    A written record would be required to be kept of any proceedings
under Rule 300(h). As the appeal procedures under proposed Rule 300(h)
would not include any provision for an oral hearing, the Exchange
expects that the written record would generally consist of (i) the
written appeal and supporting documents (if any) submitted by the
member organization and (ii) the Exchange's written determination.
Finally, the Exchange states that any member organization which
forfeits its trading licenses as of March 31, 2010 would only owe the
pro rata license fee for 2010 through that date. Any member
organization which forfeits its trading

licenses in 2010 or is ineligible to purchase trading licenses
thereafter may purchase trading licenses (to the extent there are
available unsold licenses) at such time as it is no longer three months
in arrears in its payments.

III. Discussion and Commission Findings

    The Commission finds that the proposed rule change is consistent
with the requirements of the Act and the rules and regulations
thereunder applicable to a national securities exchange \7\ and, in
particular, the requirements of Sections 6(b)(4), 6(b)(5) and 6(b)(7)
of the Act.\8\ Section 6(b)(4) of the Act \9\ requires that the rules
of the exchange provide for the equitable allocation of reasonable
dues, fees, and other charges among its members and issuers and other
persons using its facilities. Section 6(b)(5) of the Act \10\ requires,
among other things, that the rules of a national securities exchange
are not designed to permit unfair discrimination between customers,
issuers, brokers or dealers. Section 6(b)(7) of the Act \11\ requires,
among other things, that the exchange's rules provide fair procedures
for prohibiting or limiting any person with respect to access to
services offered by the exchange or member thereof.
---------------------------------------------------------------------------

    \7\ In approving this proposed rule change, the Commission has
considered the proposed rule's impact on efficiency, competition,
and capital formation. 15 U.S.C. 78c(f).
    \8\ 15 U.S.C. 78f(b)(4); 15 U.S.C. 78f(b)(5); 15 U.S.C.
78f(b)(7).
    \9\ 15 U.S.C. 78f(b)(4).
    \10\ 15 U.S.C. 78f(b)(5).
    \11\ 15 U.S.C. 78f(b)(7).
---------------------------------------------------------------------------

    The Commission believes that the proposal is consistent with
Section 6(b)(4) of the Act \12\ in that it provides for an equitable
allocation of fees among member organizations. The Exchange represents
that it relies in part on the revenues from trading license fees to pay
for the maintenance of the trading floor and to fund its trading floor
regulatory activities. The trading license fees and rules limiting the
number of trading licenses that may be initially applied for are the
same for all member organizations, and member organizations would be
denied trading floor privileges only if they have not paid the trading
license fee for several months. The Commission notes that the proposal
may encourage member organizations to pay their bills more promptly and
thereby enable the Exchange to avoid imposing the cost of the
nonpayment by a small number of member organizations on the majority of
other member organizations that routinely pay on time.
---------------------------------------------------------------------------

    \12\ 15 U.S.C. 78f(b)(4).
---------------------------------------------------------------------------

    The Commission also believes that the proposal is consistent with
Sections 6(b)(5) and 6(b)(7) of the Act. The Commission notes that the
new procedures specify procedures to provide notice to member
organizations of a pending denial or revocation. In addition, member
organizations receive monthly trading license bills that reflect unpaid
balances from previous periods. The Exchange has also represented that
it would distribute an Information Memorandum to its member
organizations to inform them of the proposed rule change.\13\
Thereafter, the procedures provide that, one calendar month prior to
the Expiration Date, the Exchange will notify each applicable member
organization that is currently two months or more in arrears in paying
monthly installments of the trading license fee payable in respect of
any previously purchased trading license of the amount of then overdue
trading license installment payments and the possibility of denial of
renewal or revocation of the trading license on the Expiration Date.
The notice must include a description of the appeal process.
---------------------------------------------------------------------------

    \13\ The first such notice will be sent to member organizations
that are two months or more in
    arrears as of the end of February 2010. See e-mail from John
Carey, Chief Counsel--U.S. Equities, NYSE Euronext LLC, to David
Liu, Assistant Director, and Leigh W. Duffy, Attorney-Adviser,
Division of Trading and Markets, Commission, dated January 25, 2010.
---------------------------------------------------------------------------

    The Commission also notes that the proposal clarifies the scope of
the Exchange's review on appeal and sets forth specific time frames for
scheduling and conducting an appeal of a pending denial or revocation.
If the member organization believes the Exchange's records are
incorrect, the member organization must submit a written appeal within
five business days of receipt of the Exchange's notice, providing an
explanation as to why it believes the Exchange's records are incorrect,
and providing copies of any relevant documentation. In addition, the
Exchange must provide a final determination in writing in response to
any such appeal no later than 15 calendar days prior to the effective
date of the potential denial of renewal or revocation of the applicable
trading license. If the Exchange denies the appeal, its written final
determination must specifically address the arguments made by the
member organization in its submission. The written determination shall
be final and conclusive action by the Exchange. In addition, the
Exchange has required a written record of any proceedings.
    For these reasons, the Commission finds that the proposed rule
change is consistent with the requirements of the Act.\14\
---------------------------------------------------------------------------

    \14\ 15 U.S.C. 78f.
---------------------------------------------------------------------------

IV. Conclusion

    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\15\ that the proposed rule change (SR-NYSE-2010-03) is hereby
approved.
---------------------------------------------------------------------------

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

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

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

Florence E. Harmon,
Deputy Secretary.
[FR Doc. 2010-5214 Filed 3-10-10; 8:45 am]
BILLING CODE 8011-01-P


U. S. Environmental Protection Agency Draft, September 9, 2003 Technical Subgroup on Degradation Test Methods for Telomers Tentative Agenda  Second Meeting ( Teleconference)

Tuesday, September 9, 2003 10: 00 AM to 1: 00 PM Meeting Location  Room 4225 in EPA East. Fifteen ( 15) teleconference lines are available for anticipated attendees who are unable to attend in person.

The call in number is 202 275 0199. The access code is 3824#.

Please note that the number of conference lines available is limited, and priority must be given to anticipated attendees. Organizations with multiple remote attendees are requested to consolidate their participants to the extent possible, so that multiple participants at the same remote location could use a single call in line.

  Review of Action Items from 8/ 14/ 2003 meeting:

TRP: review applicability of SCAS test; consider degradation products for testing or alternative proposal to screen for degradants, measurement of rate constants, and consider extending the length of the test EPA: comment on TRP proposal, review TRP logic for not testing water and air, analytical chemistry issues, degradation products issues, and consider whether we can consider drafting a soil testing proposal suitable for incorporation into an ECA by EPA and Test Sponsors   Discussion of TRP Action Items  TRP S Discussion of EPA Action Items  EPA S Next Steps U. S. Environmental Protection Agency Draft, September 4, 2003 Anticipated Attendees for September 9, 2003 Telomer Degradation Subgroup Meeting Rich Purdy Treye Thomas, CPSC John Heinze, Environmental Health Research Foundation Volker Koch, Clariant Hiroyuki Iwai, Daikin Satoshi Komatsu, Daikin Ed Lampert, Daikin Yukiko Nishiyama, Daikin Randy Roussel, Daikin Maggie Martin, Daikin Bob Buck, DuPont Bill Berti, DuPont John Gannon, DuPont Steve Korzeniowski, DuPont W. Michael McCabe ( DuPont) Bill Hardie, W. L. Gore Richard Baillie, W. L. Gore Erin Russell, Clariant Bill Beers, OMNOVA Solutions David Lynch, EPA/ EETD Bob Boethling, EPA/ EETD Andy Mamantov, EPA/ EETD Greg Fritz, EPA/ EETD Laurence Libelo, EPA/ EETD Ward Penberthy, EPA/ CCD Eric Weber, EPA/ ORD Tim Collette. EPA/ ORD Ed Heithmar, EPA/ ORD Rich Leukroth, EPA/ CCD Wendy Hoffman, EPA/ EETD Cathy Fehrenbacher, EPA/ EETD Barbara Leczynski, EPA/ CCD Mary Dominiak, EPA/ CCD ( Observer: Barbara Smyser, CPS [ TRP]) ( Observer: Katie Smythe, RAND [ TRP]) PFOA ECA Telomer Degradation Expert Subgroup Teleconference September 9, 2003 ~ Jc ~ r `~ j3~ cC~'~~ P~ JL_. NAME ORGANIZATION TELEPHONE # E MAIL ADDRESS ~~ 2i~: ~ ~* L~ ç~~

~ tQ~. L ~<~~ 9rcvv~ ~

Cokk~ backw Onu2 &. L, v, J& f ~ PA EPA ~% t~

~  s~ q ~ 0'/, 5tq~~ 2 5+~~ SJ~.\<~ jci~~ ~

A .

Ly, i~/ J. p, e~.~ V i~~ ci,~ 24~/ c' L~ P4 io~ y~ cs~ 3 L~' / c./~ c~' c~.'~ c~ G? 4~ çotJ ~ Ld~ t.~ j~ 1t~  N ~ ~: AJ V E~ A~ ~ ~` Iu~ ~ E~ Cfl ~ P~ 7x~/ s D~ UC(~

4~ 4b~ T ~~ 4~.' t~' S ~

~

~ s~ 3 ~ f j( s~~

~~ W~ rW)~ 4~~_ Ltt~ ts' F~~

~ jjcG & I ~ e~ 10 V Fr~~ ~ € pe~ jc~ V ~ C~

~`~ ii~&~ ~ n ~ co~ ~~ on cq~ C~ s 2OL~ J4 + pe~ n~ ric~ f&~ i ~ J I?~~ O~ k%~ k `)

LtS EPA ;~  ~ `/~, og 3 ~ ~

f~ f'efr1i?} Qh~ ii~

~ ~

fi ~

cFki~ J G, lj~' PJ~~ fJ 1~

~~( CCL L( S aP4 ~ / 61~

~

~

~ IiuPo~ IT 5~ 4~ 4~

~ ~   c~~ R77O z~ z~ ~ ci ~ I~/ o~

2o ~ ~ 2Oi~

7~ 3~ 4l3~ ~ c ~ 63~ 2~

~ 07c~ 0~( C ixkj~ oz~

J i~ flLcc~ J~ c~~

~

~ °  ~

~   r~ ~ n~ 4~ thcx~ cur~. Or~

~ ~ i~ A~ ~ 4~( ~ V~ dp9~ w~

Ko~ A ~

C~ i~ C~ Le~  cc7 2~? A~ a PFOA ECA Telomer Degradation Expert Subgroup Teleconference September 9, 2003 NAME ORGANIZATION TELEPHONE # E MAIL ADDRESS 4~~& nd; n~ v~ Qeph7v~:

~ 1J ~ j',/ e, Ew. ~ 4~~ 14h 7Z, sea, 4~ L~

~~/ Dlk. e4)(~ L e~ 4~ M .

1t ~ ,4 Np, ia.. r~. aar,~ t, tci~ .~

,~ I ~ il I .61. ~ 0/ 19 ~ 7   ~ Eo~ h1e;~ 4i~ r Ei~ 4 `~ 4~~ J~ iC~~ D~ 1~~

.~` k;~ 1 13~) ti3e~ s OThf~ Ob'A So/ u~ nis Cl4v, a~ fr ~ 4i~ TRP Telomer Research Program Biodegradation Technical Work Group Meeting Telomer based Polymeric Products ( TBPP) Testing Strategy 9 September 2003 2003 09 09 , page 2 Telomer Research Program Overview

Objective of Biodegradation Studies for Telomer based Polymeric Products

Analytical Considerations & Limitations

Biodegradation in Sludge

Biodegradation in Soil

Summary & Conclusions 2003 09 09 , page 3 Telomer Research Program Study Objective

Do Telomer based Polymeric Products ( TBPP) biodegrade to PFOA?

TRP recognizes that data is needed to inform this question and offers a study approach where both Telomer based Polymeric Products and Telomerbased Polymers are investigated and the desire for timely results.

Proposed Studies

address partitioning and biotransformation in relevant environmental compartments

start with laboratory studies that are simple and inform the question of whether telomer based polymeric products and telomer based polymers have the potential to transform to PFOA 2003 09 09 , page 4 Telomer Research Program Approach

Focuses on relevant releases during the life cycle of telomer based products and articles

Products and treated articles were chosen using criteria such as market end use,

chemistry type/ class, chemical volume, article type, and potential for human exposure.

Study Plans are for Telomer based Polymeric Products ( TBPP) 2003 09 09 , page 5 Telomer Research Program 80% Water 20% Telomer Polymer ° Aqueous Dispersion of .

° Polymeric Particles 100 200 nm with...

° Hydrocarbon Surfactant( s)

What is a Typical Telomer Based Polymeric Product's Composition ?

Telomer Polymeric Product Variables

wt.% active ingredient in product (~ 20%)

wt.% fluorine

wt.% Telomer raw materials

wt.% eight fluorinated carbon chain C8F17

PFOA ( from product analysis)

Mol. Wt.  Typically > 10,000 Daltons

polyacrylates

polyurethanes 2003 09 09 , page 6 Telomer Research Program Release of Telomer based polymeric products

Telomer based polymeric products ( TBPP) enter the environment

in sewage treatment plants ( stp)

in soil via sludge amendment to agricultural soils

in surface water and sediment via stp e. g. sorbed to effluent particles

in landfills from sludge or disposal of treated articles ( carpets, textiles,

paper)

TRP Conclusion : Sludge and Soil are environmental compartments where study work should be focused 2003 09 09 , page 7 Telomer Research Program Analytical Methods

First, establishing robust analytical methods for study matrices are mandatory to achieve meaningful results

Matrices

sludge, aerobic and anaerobic soil; appropriate dispersion needed

Analytes

Fluoride, PFOA and extractable Total Organic Fluorine ( TOF)

Extraction & Recovery Demonstration

analyte recovery within test time period must be acceptable

sludge 28d to 84days

soil 4 6 months

It is standard procedure to only begin testing after having established and demonstrated the appropriate analytical methods. 2003 09 09 , page 8 Telomer Research Program Demonstrating Analytical Feasibility for Environmental Matrices  General Overview Establish Dispersion Method Establish Extraction Method Establish Quantification Method Quality Check Spiking experiment Full Exposure Period Quality Check START REAL TEST Test method not applicable yes yes no no It has to be proven  ..

° that dispersion, extraction and quantification is possible ° that the development methodology is applicable to real test test conditions in Biodegradation tests over the full exposure period ( e. g. 28d, 84d or 6 months)

Improvement ? 2003 09 09 , page 9 Telomer Research Program Demonstrating Analytical Feasibility for Application to Biodegradation Studies Improvement possible ?

Matrix Proceed with STP Biodegradability Study Overall Biodegradability Testing Flow Chart Test Feasibility of Analytical Procedures Meets Quality Requirements?

NO Proceed with Soil Biodegradability Study YES YES 2003 09 09 , page 11 Telomer Research Program Sewage Treatment Plants ( STP)

Biodegradability Testing Experimental Design Discussion 2003 09 09 , page 12 Telomer Research Program Test Materials for STP Biodegradation Study Proposals

Start with  .

OECD 302 B ( Zahn Wellens / EMPA Test) on

Two ( 2) Telomer based Polymeric Products ( TBPP) & 2 Telomer based polymers isolated from TBPP Products will be from the 12 that are included in the TRP LOI

Two isolated polymers from the two Products

to understand whether the polymer alone undergoes transformation

characterization of the products and isolated polymers will be done

will enable method development and demonstration for longer term studies

provides results in short timeframe

Then  .. Conduct 302B on additional 10 polymeric products in LOI

This is a modification of the TRP LOI commitment 2003 09 09 , page 13 Telomer Research Program Test Materials for STP Biodegradation Study Proposals

In parallel, we propose to develop a study protocol to conduct

OPPTS 835.5045 " Modified SCAS Test For Insoluble and Volatile Chemicals"

need to develop and demonstrate feasible analytical methods

on two ( 2) Isolated Polymers ( from Telomer Based Polymer Products)

we want to discuss with EPA decision triggers for this study Modified Zahn Wellens/ EMPA test Telomer Based Polymer Product ( TBPP) Isolated Polymer from TBPP Does Polymer Biodegrade?

Conduct Modified SCAS Test on Isolated Polymer only*

Does TBPP Biodegrade?

Conduct Modified SCAS Test on TBPP * Residual telomer based raw materials potential contribution to PFOA is considered separately as part of the TRP 8 2 Telomer B Alcohol studies.

Phase 1: STP Biodegradability Testing Demonstrate SCAS Analytical Feasibility Decision points to be discussed Entry via STP Sludge Adsorption or Sedimentation?

 HLC?

Effluent? STOP Phase 2: STP Biodegradability Testing Aerobic Sewage Treatment Simulation Test Sludge Adsorption & Sedimentation Tests Modified SCAS Test for Insoluble and Volatile Chemicals OPPTS 835.5045 Significant Biodegradability? Significantly Adsorb or Settle in Sludge?

Consider Water &

Sediment Compartments kinetic study Decision points to be discussed 2003 09 09 , page 16 Telomer Research Program Technical Hurdles STP Study Proposals 2003 09 09 , page 17 Telomer Research Program Activated Sludge Adsorption of Telomer Based Polymer STP Study Proposals 2003 09 09 , page 18 Telomer Research Program Technical Hurdles: Activated Sludge Sorption Guideline

Reliable Analytical Methods

Need methods with sufficient accuracy to be able to extract and measure test substance in the solution and/ or the adsorbed phase Issues

Reliable Analytical Methods

Total Organic Fluorine is only available tool but is non specific

14C labeled polymer would be optimal to conduct this study, but this would require significant R& D. 2003 09 09 , page 19 Telomer Research Program Modification of OPPTS 835.5045 " Modified SCAS Test For Insoluble and Volatile Chemicals"

STP Study Proposals 2003 09 09 , page 20 Telomer Research Program Technical Hurdles: Modified SCAS Test for Insoluble and Volatile Chemicals ( OPPTS 835.5045)

Guideline

Reliable Analytical Methods

Requires use of a chemicalspecific analytical technique or 14C labeled test chemical

Biodegradability & Mass Balance

Labeled ( 14C) material required for determining transformation pathways, rates and mass balance.

Mass balance established by quantifying parent chemical in settled effluent sludge solids,

effluent plus solids, and off gases Issues

How to disperse Telomer based polymer and products in SCAS test system

Analytical Methods

Total Organic Fluorine and Fluoride ion are only available tools but are nonspecific

14C labeled polymer would be optimal , but would require significant R& D.

Biodegradability & Mass Balance

Analyze for PFOA in water and 8_ 2 Telomer B Alcohol in air trap

Need to meet data quality standards for efficient Extraction/ Clean Up methods from effluent and sludge 2003 09 09 , page 21 Telomer Research Program Guideline

Water solubility and Organic Carbon content of test chemical must be established.

Exhaust gases from aeration unit are passed through a suitable trap. Issues

How to determine water solubility and organic carbon content of Telomer

Based Polymer & Products

What is a suitable trap for potential volatiles for Telomer Based polymers and products and what are the appropriate extraction procedures?

Total Organic Fluorine : a non chemical specific endpoint in traps

Fluoride Ion in traps

8_ 2 Telomer B Alcohol in traps if can be demonstrated to be technically feasible Technical Hurdles: Modified SCAS Test for Insoluble and Volatile Chemicals ( OPPTS 835.5045) 2003 09 09 , page 22 Telomer Research Program Proposal for Modification of Performance of Test:

Modified SCAS Test ( OPPTS 835.5045)

Run study for 12 weeks

Collect and freeze samples daily over 12 weeks

Phase A: Analyze samples at Day 0, Weeks 4, 8, and 12. Assess for:

1) Total Organic Fluorine and/ or Fluoride ion in effluent and sludge solids

2) Presence of PFOA in effluent and sludge solids

3) Presence of Total Organic Fluorine and/ or Fluoride ion in Volatility traps

If levels are significant, then look for PFOA and 8_ 2 Telomer B Alcohol

If 2 & 3 are negative or insignificant concentrations, then stop

If 2 or 3 are positive and significant concentrations, then go to Phase B.

Phase B: Further analysis of frozen sludge and water samples at additional time points for PFOA, and if technically feasible, 8_ 2 Telomer B Alcohol and measurement of rate constants. Extraction of off gases* from Volatility traps ( e. g., C18) for:

Total Organic Fluorine

Fluoride [ F]

8_ 2 Telomer B Alcohol?

Extraction from Settled Effluent Sludge Solids for:

Total Organic Fluorine

Fluoride [ F]

PFOA Extraction from Effluent + Solids for:

Total Organic Fluorine

Fluoride [ F]

PFOA * If TOF or Fluoride concentrations in traps are significant, then evaluate for 8_ 2 Telomer B Alcohol if " Quality Criteria" for analytical feasibility can be met. 2003 09 09 , page 24 Telomer Research Program Modification of OECD 307 Aerobic and Anaerobic Transformations in Soil Experimental Design Discussion 2003 09 09 , page 25 Telomer Research Program Test Materials for Soil Biodegradation Study Proposals

Start By Conducting .

OECD 307 Aerobic and Anaerobic Transformations in Soil

Two ( 2) Telomer based polymers isolated from TBPP Products will be from the 12 that are included in the TRP LOI

Two isolated polymers from the two Products

to understand whether the polymer alone undergoes transformation

characterization of the products and isolated polymers will be done

will enable method development and demonstration 2003 09 09 , page 26 Telomer Research Program Biodegradation Testing in Soil Testing Strategy Pilot Study

Pilot study Modified OECD 307 Test setting

Establishing and Verification of the Analytical method for 120 to 180d Exposure

Testing two isolated polymers

Use of the OECD 307 ( Aerobic and anaerobic transformation in soil) setting

apply aerobic and anaerobic conditions

Application of testing methodology to other TRP TBPPs

review results from pilot study to determine whether additional polymers should be investigated

Kinetic investigations

only if PFOA amount would reach a certain level in relation to the overall C8F17 content in TBPPs 2003 09 09 , page 27 Telomer Research Program Technical Hurdles Soil Study Proposals 2003 09 09 , page 28 Telomer Research Program Technical Hurdles:

Aerobic and Anaerobic Transformation in Soil Guideline

Analytical Methods

Applicable to all chemical substances which have analytical methods available with sufficient accuracy and sensitivity

Biodegradability & Mass Balance

Labeled ( 14C) material required for determining transformation pathways, rates and mass balance Issues

How to get equal distribution of Telomer based polymer in soil matrix

Analytical Methods

Non chemical Specific Analytical limitation for cold studies

14C labeled polymer would be optimal , but would require significant R& D.

Need to meet data quality standards for efficient Extraction/ Clean Up methods

LOD's & LOQ's for each endpoint described below needs to be established

Biodegradability & Mass Balance

Analyze for PFOA in test system

Total Organic Fluorine in test system and extract from traps

Fluoride Ion in extract from traps

if TOF or Fluoride ion from traps is significant,

then evaluate traps for 8_ 2 Telomer B Alcohol 2003 09 09 , page 29 Telomer Research Program Proposal for Modification of Performance of Test: Aerobic and Anaerobic Transformation in Soil ( OECD 307)

Run study for 6 months

Collect and freeze samples ( frequency: weekly) over 6 months

Use a Flow through System with traps for volatiles.

Phase A: Analyze samples at Day 0, 2 Months, 4 Months and 6 Months. Assess for:

1) Total Organic Fluorine in soil ( aerobic) & soil/ water phases ( anaerobic)

2) Presence of PFOA in soil ( aerobic) & soil/ water phases ( anaerobic)

3) Presence of Total Organic Fluorine and/ or Fluoride ion in Volatility traps

If levels are significant, then look for PFOA and 8_ 2 Telomer B Alcohol

If 2 & 3 are negative or insignificant concentrations, then stop

If 2 or 3 are positive and significant concentrations, then go to Phase B.

Phase B: Further analysis of frozen samples for PFOA, 8_ 2 Telomer B Alcohol,

and measurement of rate constants if technically feasible.

Provide report at completion of study.


[Federal Register Volume 83, Number 238 (Wednesday, December 12, 2018)]
[Notices]
[Pages 63853-63855]
[FR Doc No: 2018-26888]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP19-7-000]

Tennessee Gas Pipeline Company, LLC; Notice of Intent To Prepare
an Environmental Assessment for the Proposed 261 Upgrade Projects and
Request for Comments on Environmental Issues

    The staff of the Federal Energy Regulatory Commission (FERC or
Commission) will prepare an environmental assessment (EA) that will
discuss the environmental impacts of the 261 Upgrade Projects involving
construction and operation of facilities by Tennessee Gas Pipeline
Company, LLC (Tennessee Gas) in Agawam, Massachusetts and Suffield,
Connecticut. The Commission will use this EA in its decision-making
process to determine whether the project is in the public convenience
and necessity.
    This notice announces the opening of the scoping process the
Commission will use to gather input from the public and interested
agencies about issues regarding the project. The National Environmental
Policy Act (NEPA) requires the Commission to take into account the
environmental impacts that could result from its action whenever it
considers the issuance of a Certificate of Public Convenience and
Necessity.

NEPA also requires the Commission to discover concerns the public may
have about proposals. This process is referred to as scoping. The main
goal of the scoping process is to focus the analysis in the EA on the
important environmental issues. By this notice, the Commission requests
public comments on the scope of the issues to address in the EA. To
ensure that your comments are timely and properly recorded, please
submit your comments so that the Commission receives them in
Washington, DC on or before 5:00 p.m. Eastern Time on January 7, 2019.
    You can make a difference by submitting your specific comments or
concerns about the project. Your comments should focus on the potential
environmental effects, reasonable alternatives, and measures to avoid
or lessen environmental impacts. Your input will help the Commission
staff determine what issues they need to evaluate in the EA. Commission
staff will consider all filed comments during the preparation of the
EA.
    If you sent comments on this project to the Commission before the
opening of this docket on October 19, 2018, you will need to file those
comments in Docket No. CP19-7-000 to ensure they are considered as part
of this proceeding.
    This notice is being sent to the Commission's current environmental
mailing list for this project. State and local government
representatives should notify their constituents of this proposed
project and encourage them to comment on their areas of concern.
    If you are a landowner receiving this notice, a pipeline company
representative may contact you about the acquisition of an easement to
construct, operate, and maintain the proposed facilities. The company
would seek to negotiate a mutually acceptable easement agreement. You
are not required to enter into an agreement. However, if the Commission
approves the project, that approval conveys with it the right of
eminent domain. Therefore, if you and the company do not reach an
easement agreement, the pipeline company could initiate condemnation
proceedings in court. In such instances, compensation would be
determined by a judge in accordance with state law.
    Tennessee Gas provided landowners with a fact sheet prepared by the
FERC entitled An Interstate Natural Gas Facility On My Land? What Do I
Need To Know? This fact sheet addresses a number of typically asked
questions, including the use of eminent domain and how to participate
in the Commission's proceedings. It is also available for viewing on
the FERC website (www.ferc.gov) at https://www.ferc.gov/resources/guides/gas/gas.pdf.

Public Participation

    The Commission offers a free service called eSubscription which
makes it easy to stay informed of all issuances and submittals
regarding the dockets/projects to which you subscribe. These instant
email notifications are the fastest way to receive notification and
provide a link to the document files which can reduce the amount of
time you spend researching proceedings. To sign up go to www.ferc.gov/docs-filing/esubscription.asp.
    For your convenience, there are three methods you can use to submit
your comments to the Commission. The Commission encourages electronic
filing of comments and has staff available to assist you at (866) 208-
3676 or<EMAIL_ADDRESS>Please carefully follow these
instructions so that your comments are properly recorded.
    (1) You can file your comments electronically using the eComment
feature, which is located on the Commission's website (www.ferc.gov)
under the link to Documents and Filings. Using eComment is an easy
method for submitting brief, text-only comments on a project;
    (2) You can file your comments electronically by using the eFiling
feature, which is located on the Commission's website (www.ferc.gov)
under the link to Documents and Filings. With eFiling, you can provide
comments in a variety of formats by attaching them as a file with your
submission. New eFiling users must first create an account by clicking
on eRegister. You will be asked to select the type of filing you are
making; a comment on a particular project is considered a ``Comment on
a Filing''; or
    (3) You can file a paper copy of your comments by mailing them to
the following address. Be sure to reference the project docket number
(CP19-7-000) with your submission: Kimberly D. Bose, Secretary, Federal
Energy Regulatory Commission, 888 First Street NE, Room 1A, Washington,
DC 20426.

Summary of the Proposed Project

    Tennessee Gas proposes to perform the following activities for
construction of the Project to provide 72,400 million cubic feet per
day (Mcf/d) of natural gas per day to meet existing subscribed shippers
need for capacity.
    The 261 Upgrade Projects would consist of the following facilities:
     Installation of 2.4 miles of 12-inch-diameter pipeline
loop; \1\
---------------------------------------------------------------------------

    \1\ A pipeline loop is a segment of pipe constructed parallel to
an existing pipeline to increase capacity. A ``pig'' is a tool that
the pipeline company inserts into and pushes through the pipeline
for cleaning the pipeline, conducting internal inspections, or other
purposes.
---------------------------------------------------------------------------

     installation of pig launcher and receiver facilities;
     installation of one new Solar Taurus compressor unit to
replace two existing compressor units to be removed at Compressor
station (CS) 261; and
     removal and replacement of one emergency generator.
    The general location of the project facilities is shown in appendix
1.\2\
---------------------------------------------------------------------------

    \2\ The appendices referenced in this notice will not appear in
the Federal Register. Copies of appendices were sent to all those
receiving this notice in the mail and are available at www.ferc.gov
using the link called eLibrary or from the Commission's Public
Reference Room, 888 First Street NE, Washington, DC 20426, or call
(202) 502-8371. For instructions on connecting to eLibrary, refer to
the last page of this notice.
---------------------------------------------------------------------------

Land Requirements for Construction

    Construction of the Project would disturb about 38.35 acres of land
in Massachusetts and 8 acres in Connecticut for the aboveground
facilities and the pipeline loop. Following construction, Tennessee Gas
would maintain about 5.37 acres in Massachusetts for permanent
operation of the project's facilities; the remaining acreage would be
restored and revert to former uses. About 100 percent of the proposed
pipeline loop would be co-located with Tennessee Gas's existing
facilities, other utilities and roadways. This includes 71 percent of
that pipeline loop that would overlap with the permanent easement of
Tennessee Gas's Line 261B-100 or on Tennessee Gas owned CS 261
property, 10 percent that would overlap with other utilities and
roadway corridors, and 19 percent that would be located adjacent to
these corridors.

The EA Process

    The EA will discuss impacts that could occur as a result of the
construction and operation of the proposed project under these general
headings:
     Geology and soils;
     water resources and wetlands;
     vegetation and wildlife;
     threatened and endangered species;
     cultural resources;
     land use;
     air quality and noise;
     public safety; and
     cumulative impacts.
    Commission staff will also evaluate reasonable alternatives to the
proposed project or portions of the project, and

make recommendations on how to lessen or avoid impacts on the various
resource areas.
    The EA will present Commission staffs' independent analysis of the
issues. The EA will be available in electronic format in the public
record through eLibrary \3\ and the Commission's website (https://www.ferc.gov/industries/gas/enviro/eis.asp). If eSubscribed, you will
receive instant email notification when the EA is issued. The EA may be
issued for an allotted public comment period. Commission staff will
consider all comments on the EA before making recommendations to the
Commission. To ensure Commission staff have the opportunity to address
your comments, please carefully follow the instructions in the Public
Participation section, beginning on page 2.
---------------------------------------------------------------------------

    \3\ For instructions on connecting to eLibrary, refer to the
last page of this notice.
---------------------------------------------------------------------------

    With this notice, the Commission is asking agencies with
jurisdiction by law and/or special expertise with respect to the
environmental issues of this project to formally cooperate in the
preparation of the EA.\4\ Agencies that would like to request
cooperating agency status should follow the instructions for filing
comments provided under the Public Participation section of this
notice. Currently, the U.S. Army Corps of Engineers has expressed its
intention to participate as a cooperating agency in the preparation of
the EA to satisfy NEPA responsibilities related to this project.
---------------------------------------------------------------------------

    \4\ The Council on Environmental Quality regulations addressing
cooperating agency responsibilities are at Title 40, Code of Federal
Regulations, part 1501.6.
---------------------------------------------------------------------------

Consultation Under Section 106 of the National Historic Preservation
Act

    In accordance with the Advisory Council on Historic Preservation's
implementing regulations for section 106 of the National Historic
Preservation Act, the Commission is are using this notice to initiate
consultation with the applicable State Historic Preservation Offices
(SHPO), and to solicit their views and those of other government
agencies, interested Indian tribes, and the public on the project's
potential effects on historic properties.\5\ Commission staff will
define the project-specific Area of Potential Effects (APE) in
consultation with the SHPOs as the project develops. On natural gas
facility projects, the APE at a minimum encompasses all areas subject
to ground disturbance (examples include construction right-of-way,
contractor/pipe storage yards, compressor stations, and access roads).
The EA for this project will document findings on the impacts on
historic properties and summarize the status of consultations under
section 106.
---------------------------------------------------------------------------

    \5\ The Advisory Council on Historic Preservation's regulations
are at Title 36, Code of Federal Regulations, part 800. Those
regulations define historic properties as any prehistoric or
historic district, site, building, structure, or object included in
or eligible for inclusion in the National Register of Historic
Places.
---------------------------------------------------------------------------

Environmental Mailing List

    The environmental mailing list includes federal, state, and local
government representatives and agencies; elected officials;
environmental and public interest groups; Native American Tribes; other
interested parties; and local libraries and newspapers. This list also
includes all affected landowners (as defined in the Commission's
regulations) who are potential right-of-way grantors, whose property
may be used temporarily for project purposes, or who own homes within
certain distances of aboveground facilities, and anyone who submits
comments on the project. Commission staff will update the environmental
mailing list as the analysis proceeds to ensure that Commission notices
related to this environmental review are sent to all individuals,
organizations, and government entities interested in and/or potentially
affected by the proposed project.
    If the Commission issues the EA for an allotted public comment
period, a Notice of Availability of the EA will be sent to the
environmental mailing list and will provide instructions to access the
electronic document on the FERC's website (www.ferc.gov). If you need
to make changes to your name/address, or if you would like to remove
your name from the mailing list, please return the attached ``Mailing
List Update Form'' (appendix 2).

Additional Information

    Additional information about the project is available from the
Commission's Office of External Affairs, at (866) 208-FERC, or on the
FERC website at www.ferc.gov using the eLibrary link. Click on the
eLibrary link, click on General Search and enter the docket number in
the Docket Number field, excluding the last three digits (i.e., CP19-
7). Be sure you have selected an appropriate date range. For
assistance, please contact FERC Online Support at
<EMAIL_ADDRESS>or<PHONE_NUMBER>, or for TTY, contact (202)
502-8659. The eLibrary link also provides access to the texts of all
formal documents issued by the Commission, such as orders, notices, and
rulemakings.
    Public sessions or site visits will be posted on the Commission's
calendar located at www.ferc.gov/EventCalendar/EventsList.aspx along
with other related information.

    Dated: December 6, 2018.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2018-26888 Filed 12-11-18; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 88, Number 186 (Wednesday, September 27, 2023)]
[Notices]
[Page 66469]
[FR Doc No: 2023-21001]

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

DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4691-DR; Docket ID FEMA-2023-0001]

Tennessee; Amendment No. 2 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 Tennessee (FEMA-4691-DR), dated March 8, 2023, and
related determinations.

DATES: This change occurred on August 15, 2023.

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 Federal Emergency Management Agency
(FEMA) hereby gives notice that pursuant to the authority vested in the
Administrator, under Executive Order 12148, as amended, Yolanda J.
Jackson, of FEMA is appointed to act as the Federal Coordinating
Officer for this disaster.
    This action terminates the appointment of Andrew D. Friend as
Federal Coordinating Officer for this disaster.

    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.

Deanne Criswell,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2023-21001 Filed 9-26-23; 8:45 am]
BILLING CODE 9111-23-P