[Federal Register Volume 85, Number 56 (Monday, March 23, 2020)]
[Notices]
[Pages 16398-16400]
[FR Doc No: 2020-06000]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-88398; File No. SR-NYSEARCA-2020-22]

Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change of a Temporary
Waiver of the Co-Location Hot Hands Fee

March 17, 2020.
    Pursuant to Section 19(b)(1) \1\ of the Securities Exchange Act of
1934 (the ``Act'') \2\ and Rule 19b-4 thereunder,\3\ notice is hereby
given that, on March 16, 2020, NYSE Arca, Inc. (``NYSE Arca'' or the
``Exchange'') filed with the Securities and Exchange Commission (the
``Commission'') the proposed rule change as described in Items I, II,
and III below, which Items have been prepared by the self-regulatory
organization. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 15 U.S.C. 78a.
    \3\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes a temporary waiver of the co-location ``Hot
Hands'' fee beginning on March 16, 2020 through March 29, 2020. The
proposed rule change is available on the Exchange's website at
www.nyse.com, at the principal office of the Exchange, and at the
Commission's Public Reference Room.

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

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

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

1. Purpose
    The Exchange proposes a temporary suspension of the co-location \4\
``Hot Hands'' fee beginning on March 16, 2020 through March 29, 2020,
after which the Mahwah, New Jersey data center (``Data Center'') is
scheduled to reopen to third parties.
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    \4\ The Exchange initially filed rule changes relating to its
co-location services with the Securities and Exchange Commission
(``Commission'') in 2010. See Securities Exchange Act Release No.
63275 (November 8, 2010), 75 FR 70048 (November 16, 2010) (SR-
NYSEArca-2010-100).
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    The Exchange is an indirect subsidiary of Intercontinental
Exchange, Inc. (``ICE''). Through its ICE Data Services (``IDS'')
business, ICE operates the Data Center, from which the Exchange
provides co-location services to Users.\5\
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    \5\ For purposes of the Exchange's co-location services, a
``User'' means any market participant that requests to receive co-
location services directly from the Exchange. See Securities
Exchange Act Release No. 76010 (September 29, 2015), 80 FR 60197
(October 5, 2015) (SR-NYSEArca-2015-82). As specified in the NYSE
Arca Options Fees and Charges and the NYSE Arca Equities Fees and
Charges (together, the ``Fee Schedules''), a User that incurs co-
location fees for a particular co-location service pursuant thereto
would not be subject to co-location fees for the same co-location
service charged by the Exchange's affiliates the New York Stock
Exchange LLC (``NYSE''), NYSE American LLC (``NYSE American''), NYSE
Chicago, Inc. (``NYSE Chicago''), and NYSE National, Inc. (``NYSE
National'' and together, the ``Affiliate SROs''). See Securities
Exchange Act Release No. 70173 (August 13, 2013), 78 FR 50459
(August 19, 2013) (SR-NYSEArca-2013-80). Each Affiliate SRO has
submitted substantially the same proposed rule change to propose the
changes described herein. See SR-NYSE-2020-18, SR-NYSEAmer-2020-19,
SR-NYSECHX-2020-07, and SR-NYSENAT-2020-10.

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    Among those services is a ``Hot Hands'' service, which allows Users
to use on-site Data Center personnel to maintain User equipment,
support network troubleshooting, rack and stack a server in a User's
cabinet; power recycling; and install and document the fitting of cable
in a User's cabinet(s).\6\ The Hot Hands fee is $100 per half hour.
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    \6\ See Securities Exchange Act Release No. 72720 (July 30,
2014), 79 FR 45577 (August 5, 2014) (SR-NYSEArca-2014-81).
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    ICE has announced to each User that, starting March 16, 2020, the
Data Center will be closed to third parties through March 29, 2020.
Pursuant to the ICE contingency plan, the Data Center is being closed
to third parties to help avoid the spread of COVID-19, which could
negatively impact Data Center functions. The President of the Exchange
has taken the actions required under NYSE Arca Rules 7.1-E and 7.1-O to
close the co-location facility of the Exchange to third parties.\7\
While the Rules 7.1-E and 7.1-O closures are in effect, User
representatives will not be allowed access to the Data Center.
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    \7\ See NYSE Arca Rules 7.1-E(c) through (e) and 7.1-O(c)
through (e). See also NYSE Rule 7.1, NYSE American Rules 7.1E and
901NY, NYSE Chicago Rule 7.1, and NYSE National Rule 7.1.
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    If a User's equipment requires work while the Rules 7.1-E and 7.1-O
closures are in effect, the User will have no option but to use the Hot
Hands service and, absent the proposed waiver, would incur Hot Hands
fees for the work. Given that, the Exchange proposes to waive all Hot
Hands fees from the date of the closing through March 29, 2020, and to
add text to the Hot Hands Fee in the Fee Schedules noting the waiver.
The Exchange believes that there will be sufficient Data Center staff
on-site to comply with User requests for Hot Hands service.
    The proposed waiver would apply equally to all Users. The proposed
fee waiver would not apply differently to distinct types or sizes of
market participants. Rather, it would apply uniformly to all Users.
    The proposed change is not otherwise intended to address any other
issues relating to co-location services and/or related fees, and the
Exchange is not aware of any problems that Users would have in
complying with the proposed change.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with Section 6(b) of the Act,\8\ in general, and furthers the
objectives of Sections 6(b)(4) and (5) of the Act,\9\ in particular,
because it provides for the equitable allocation of reasonable dues,
fees, and other charges among its members, issuers and other persons
using its facilities and does not unfairly discriminate between
customers, issuers, brokers or dealers. In addition, it is designed to
foster cooperation and coordination with persons engaged in regulating,
clearing, settling, processing information with respect to, and
facilitating transactions in securities, to remove impediments to, and
perfect the mechanisms of, a free and open market and a national market
system and, in general, to protect investors and the public interest
and because it is not designed to permit unfair discrimination between
customers, issuers, brokers, or dealers.
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    \8\ 15 U.S.C. 78f(b).
    \9\ 15 U.S.C. 78f(b)(4) and (5).
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The Proposed Rule Change Is Reasonable
    The Exchange believes that the proposed rule change is reasonable
for the following reasons.
    While the Rules 7.1-E and 7.1-O closures are in effect, User
representatives will not be allowed access to the Data Center. If a
User's equipment requires work during such period, the User will have
to use the Hot Hands service and, absent a waiver, would incur Hot
Hands fees for the work. The Exchange believes that it is reasonable to
grant the proposed waiver because Users would have no option other than
using the Hot Hands service.
    The proposed relief would allow a User to have work carried out on
its equipment notwithstanding the closure of the Data Center without
incurring Hot Hands fees.
The Proposed Rule Change Is Equitable
    The Exchange believes the proposed rule change is an equitable
allocation of its fees and credits for the following reasons.
    The proposed waiver would apply equally to all Users. The proposed
fee waiver would not apply differently to distinct types or sizes of
market participants. Rather, it would apply uniformly to all Users.
    The Exchange believes that the proposal is equitable because all
similarly-situated Users would not be charged a fee to use the Hot
Hands service that the User would have to use because of the Data
Center closure.
The Proposed Change Is Not Unfairly Discriminatory and Would Protect
Investors and the Public Interest
    The Exchange believes that the proposed change is not unfairly
discriminatory for the following reasons.
    The proposed waiver would not apply differently to distinct types
or sizes of market participants. Rather, all Users whose equipment
requires work during the Data Center closure would have the resulting
fees waived, and the waiver would apply uniformly to all Users from
March 16, 2020 through March 29, 2020. For the reasons above, the
proposed changes do not unfairly discriminate between or among market
participants.
    In addition, the Exchange believes that the proposed rule change
would perfect the mechanisms of a free and open market and a national
market system and, in general, protect investors and the public
interest because it would allow a User to have work carried out on its
equipment notwithstanding the closure of the Data Center pursuant to
Rules 7.1-E and 7.1-O without incurring Hot Hands fees. Accordingly,
the Exchange believes that the requested relief is designed to perfect
the mechanisms of a free and open market and a national market system
and, in general, protect investors and the public interest by
facilitating the uninterrupted availability of Users' equipment.
    For all of the above reasons, the Exchange believes that the
proposal is consistent with the Act.

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

    In accordance with Section 6(b)(8) of the Act,\10\ the Exchange
believes that the proposed rule change will not impose any burden on
competition that is not necessary or appropriate in furtherance of the
purposes of the Act.
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    \10\ 15 U.S.C. 78f(b)(8).
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Intramarket Competition
    The Exchange does not believe that the proposed change would place
any burden on intramarket competition that is not necessary or
appropriate.
    The proposal it is not designed to affect competition, but rather
to provide relief to Users that, while the Rules 7.1-E and 7.1-O
closures are in effect, have no option but to use the Hot Hands
service.
    The proposed waiver would not apply differently to distinct types
or sizes of

market participants. All Users who use the Hot Hands service from March
16, 2020 through March 29, 2020 would have the resulting fees waived.
Intermarket Competition
    The Exchange does not believe that the proposed change would impose
any burden on intermarket competition that is not necessary or
appropriate.
    The Exchange believes that the proposed change would not affect the
competitive landscape among the national securities exchanges, as the
Hot Hands service is solely charged within co-location to existing
Users, and would be temporary.
    For the reasons described above, the Exchange believes that the
proposed rule change reflects this competitive environment.

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

    The foregoing rule change is effective upon filing pursuant to
Section 19(b)(3)(A) \11\ of the Act and subparagraph (f)(2) of Rule
19b-4 \12\ thereunder, because it establishes a due, fee, or other
charge imposed by the Exchange.
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    \11\ 15 U.S.C. 78s(b)(3)(A).
    \12\ 17 CFR 240.19b-4(f)(2).
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    At any time within 60 days of the filing of such proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission shall institute proceedings under
Section 19(b)(2)(B) \13\ of the Act to determine whether the proposed
rule change should be approved or disapproved.
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    \13\ 15 U.S.C. 78s(b)(2)(B).
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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 is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-NYSEARCA-2020-22 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NYSEARCA-2020-22. 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 website (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 website viewing and printing in
the Commission's Public Reference Room, 100 F Street NE, Washington, DC
20549 on official business days between the hours of 10:00 a.m. and
3:00 p.m. Copies of the filing also will be available for inspection
and copying at the principal office of the Exchange. All comments
received will be posted without change. Persons submitting comments are
cautioned that we do not redact or edit personal identifying
information from comment submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File Number SR-NYSEARCA-2020-22 and should be submitted
on or before April 13, 2020.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\14\
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    \14\ 17 CFR 200.30-3(a)(12).
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J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2020-06000 Filed 3-20-20; 8:45 am]
BILLING CODE 8011-01-P


DuPont Chemical Solutions Enterprise

Chambers Works

Deepwater, NJ  08023

CERTIFIED MAIL – Return Receipt Requested

August 21, 2007

Document Control Office

US Environmental Protection Agency

Office of Pollution Prevention and Toxics

EPA East

Room 6428

1200 Pennsylvania Avenue, NW

Washington, DC 20460

Re: 	EPA – HQ – OPPT – 2003 - 0012

	DuPont Chambers Works NJPDES Permit No. NJ0005100

	PFOA Data Submittal – Outfall DSN662 Weekly Grab Samples

	May 2007 Sample Data

Dear Document Control Office,

As per Part IV, Section G.5.a of the NJPDES permit, we are submitting a summary of PFOA analytical results for the weekly grab samples taken at internal outfall DSN662A to NJDEP on a monthly basis. Per your request, we are sending you a paper and electronic copy of the report for samples taken during May 2007. We will continue to send you the reports each month.

If you have any questions, please do not hesitate to call me at (856) 540-3105.

Sincerely,

Karen L. Pinder

SET Environmental Coordinator

DuPont Chambers Works

Enclosures

Copies to:

Director, Chemical Control Division

US Environmental Protection Agency

Office of Pollution Prevention and Toxics

EPA East

Room 4146

1201 Constitution Avenue, NW

Washington, DC 20004

Ms. Susan Rosenwinkel (cover letter only)

Principal Environmental Engineer

NJDEP Division of Water Quality

Bureau of Point Source Permitting – Region 2

401 E. State Street

P.O. Box 029

Trenton, NJ 08625-0029


[Federal Register: February 6, 2009 (Volume 74, Number 24)]
[Rules and Regulations]
[Page 6228-6229]
[DOCID:fr06fe09-5]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2008-1263]

Drawbridge Operation Regulation; Bayou Lacarpe, Mile 7.5, at
Houma, Lafourche Parish, LA

AGENCY: Coast Guard, DHS.

ACTION: Notice of temporary deviation from regulations.

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SUMMARY: The Commander, Eighth Coast Guard District, has issued a
temporary deviation from the regulation governing the operation of the
SR 661 Vertical Lift Bridge across Bayou Lacarpe, mile 7.5, at Houma,
Lafourche Parish, Louisiana. The deviation is necessary to replace all
the wire ropes used to lift the movable span of the bridge. This
deviation allows the bridge to remain closed during daytime hours and
requires an advance notice for openings during the nighttime.

DATES: This deviation is effective from 9 a.m. on January 31, 2009
through 5 p.m. on February 14, 2009.

ADDRESSES: Documents indicated in this preamble as being available in
the docket are part of docket USCG-2008-1263 and are available online
at www.regulations.gov. They are also available for inspection or
copying at two locations: the Docket Management Facility (M-30), U.S.
Department of Transportation, West Building Ground Floor, Room W12-140,
1200 New Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays, and the Eighth
Coast Guard District, Bridge Administration Branch, Hale Boggs Federal
Building, Room 1313, 500 Poydras Street, New Orleans, Louisiana 70130-
3310 between 7 a.m. and 3 p.m., Monday through Friday, except Federal
holidays.

FOR FURTHER INFORMATION CONTACT: Bart Marcules, Bridge Administration
Branch, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Louisiana Department of Transportation and
Development has requested a temporary deviation from the operating
schedule of the State Route 661 Vertical Lift Bridge across Bayou
Lacarpe, mile 7.5, at Houma, Lafourche Parish, Louisiana. The vertical
clearance in the closed position is 3 feet, thus most vessels will not
be able to pass underneath this bridge in the closed-to-navigation
position. There may be times, during the closure period, when the draw
will not

be able to open for emergencies. The bridge normally operates in
accordance with 33 CFR 117.460 on signal with at least a four hour
advance notice except that it need not open on weekdays except holidays
from 7 a.m. to 8:30 a.m. and 4:30 p.m. to 6 p.m. This deviation will
allow the bridge to remain in the closed-to-navigation position from 9
a.m. to 6 p.m. and will open on signal if at least 24 hour notice is
given from 6 p.m. to 9 a.m. starting January 31, 2009 through February
14, 2009. During the closure periods the wire ropes used for lifting
the movable span will all be changed. Navigation on the waterway
consists of tugs with tows, fishing vessels and recreational craft. Due
to prior experience, as well as coordination with waterway users, and
an alternate route, it has been determined that this closure will not
have a significant effect on these vessels.
    In accordance with 33 CFR 117.35(e), the drawbridge must return to
its regular operating schedule immediately at the end of the designated
time period. This deviation from the operating regulations is
authorized under 33 CFR 117.35.

    Dated: January 12, 2009.
David M. Frank,
Bridge Administrator.
[FR Doc. E9-2492 Filed 2-5-09; 8:45 am]

BILLING CODE 4910-15-P


[Federal Register: August 27, 2008 (Volume 73, Number 167)]
[Notices]
[Page 50661-50663]
[DOCID:fr27au08-87]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-58407; File No. SR-DTC-2008-10]

Self-Regulatory Organizations; The Depository Trust Company;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change To
Make Technical Changes to the Collateral Loan System

August 21, 2008.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ notice is hereby given that on August 1, 2008, The
Depository Trust Company (``DTC'') filed with the Securities and
Exchange Commission (``Commission'') the proposed rule change described
in Items I, II, and III below, which items have been prepared primarily
by DTC. DTC filed the proposal pursuant to Section 19(b)(3)(A)(iii) of
the Act \2\ and Rule 19b-4(f)(4) \3\ thereunder so that the proposal
was effective upon filing with the Commission. The Commission is
publishing this notice to solicit comments on the rule change from
interested parties.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \3\ 17 CFR 240.19b-4(f)(4).
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The purpose of the rule change is to (i) modify record layouts for
the Collateral Loan System to comply with the new Symbology series key
defined by the Options Symbology Initiative (``OSI'') and (ii)
implement record layout changes that will allow The Options Clearing
Corporation (``OCC'') members to process collateral loan transactions
directly against OCC sub-accounts.\4\
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    \4\ For more information regarding the record layout changes,
see DTC Important Notice B 3577-08. http://www.dtcc.com/downloads/
legal/imp_notices/2008/dtc/set/3577-08.pdf.
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II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, DTC 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. DTC has prepared summaries, set forth in sections (A),
(B), and (C) below, of the most significant aspects of these
statements.\5\
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    \5\ The Commission has modified the text of the summaries
prepared by DTC.
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(A) Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Options Symbology Initiative
    Currently organizations that support trading in listed options
typically use a three to five alpha character representation. The first
three characters identify the option root symbol, and the remaining two
alpha characters identify the expiration month, call/put indicator, and
strike price. In an effort to standardize option symbols and overhaul
the existing method of identifying exchange-listed options contracts,
OCC is spearheading an industry-wide adoption of the OSI.\6\
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    \6\ For more information about The Options Clearing
Corporation's Options Symbology Initiative see the most recent plan
at http://www.theocc.com/initiatives/symbology/implementation_
plan.jsp.
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    The OSI supports the elimination of alpha codes that are currently
used to denote expiration month, call/put code, and strike price. As a
result, DTC is proposing to modify its record layouts for DTC's
Collateral Loan System to

comply with the new Symbology series key defined by the OSI. DTC
believes these changes will increase efficiency and improve the
mechanism for participants to perform under the OSI initiative.
2. OCC Sub-Accounting Initiative
    The purpose of the OCC sub-accounting initiative is to eliminate
the need for multiple OCC clearing member numbers. OCC sub-accounting
also allows OCC clearing members to separate retail and professional
customers for purposes of reserve/PAIB computations \7\ and to separate
traditional and portfolio margin customers for purposes of portfolio
margining. In support of the OCC sub-accounting initiative, OCC has
requested that DTC implement record layout changes that will allow OCC
members to process collateral loan transactions directly against these
OCC sub-accounts.
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    \7\ Commission customer protection rules require firms to
compute the amount a clearing firm must place in a reserve account
to back their customers' assets. There are effectively two
calculations: One for retail customers (``Reserve'') and one for the
proprietary accounts of introducing brokers (``PAIB''). Under both
of these calculations the clearing firm is allowed to take as a
debit in the calculation OCC's clearing level margin associated with
these customers' positions. At the clearinghouse level both Reserve
and PAIB customers are cleared in the customer range, and currently
only one margin requirement is produced. Since the OCC margin
requirement is comprised of both Reserve and PAIB clients, clearing
firms do not use the OCC margin requirement as a debit in their
computations. As a result, firms have to post more in their Reserve
accounts since they cannot use the offsets provided for under
Commission customer protection rules.
    OCC sub-accounting would provide clearing firms with the ability
to maintain subaccounts under the customer range for Reserve
customers and PAIB customers. As a result, OCC could compute two
separate margin requirements to which the clearing firm can post
collateral and apply Reserve and PAIB calculations. This would free
up additional liquidity for clearing firms that currently cannot
include the OCC margin in the customer protection rule computations
due to the inability to create a subaccount.
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    The OCC has mandated that modifications for the OSI and the OCC
sub-accounting initiative be implemented simultaneously because both
initiatives require modifications to input and output file formats as
well as some of DTC's screen based applications on the Participant
Terminal System (``PTS'') and Participant Browser Services
(``PBS'').\8\ OCC has requested that DTC implement these changes on
August 8, 2008, so that OCC members can begin to migrate to the new
formats. OCC has mandated that OCC members be ready to use the new
formats by October 10, 2008.
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    \8\ Participants use DTC's Collateral Loan function on the PTS
to pledge securities to OCC in order to meet OCC's option
collateralization requirements. Participants can also use PTS to
input requests for the release of securities pledged to OCC, and OCC
can use PTS to approve or cancel release requests.
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    The proposed rule change is consistent with Section 17A of the
Act,\9\ as amended, because it will reduce operational and financial
risks associated with multiple OCC clearing member numbers thereby
promoting the prompt and accurate clearance and settlement of
securities transactions. Additionally, record layout modifications will
increase efficiency and improve the mechanism for DTC Participants to
perform under the OSI initiative.
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    \9\ 15 U.S.C. 78q-1.
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(B) Self-Regulatory Organization's Statement on Burden on Competition

    DTC does not believe that the proposed rule change will have any
impact or impose any burden on competition.

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

    Written comments relating to the proposed rule change have not yet
been solicited or received. DTC will notify the Commission of any
written comments received by DTC.

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

    The foregoing proposed rule change has become effective upon filing
pursuant to Section 19(b)(3)(A)(iii) of the Act \10\ and Rule 19b-
4(f)(4) \11\ thereunder because the proposed rule change effects a
change in an existing service of a registered clearing agency that: (i)
does not adversely affect the safeguarding of securities or funds in
the custody or control of the clearing agency or for which it is
responsible and (ii) does not significantly affect the respective
rights or obligations of the clearing agency or persons using the
service. At any time within sixty days of the filing of the proposed
rule change, the Commission may summarily abrogate such rule change if
it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act.
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    \10\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \11\ 17 CFR 240.19b-4(f)(4).
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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 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 e-mail to<EMAIL_ADDRESS>Please include
File Number SR-DTC-2008-10 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-DTC-2008-10. 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://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, 100 F Street, NE.,
Washington, DC 20549, on official business days between the hours of 10
a.m. and 3 p.m. Copies of such filings also will be available for
inspection and copying at the principal office of DTC and on DTC's Web
site at http://www.dtcc.com/downloads/legal/rule_filings/2008/dtc/
2008-10.pdf. 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-DTC-
2008-10 and should be submitted on or before September 17, 2008.
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    \12\ 17 CFR 200.30-3(a)(12).

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    For the Commission by the Division of Trading and Markets,
pursuant to delegated authority.\12\
Florence E. Harmon,
Acting Secretary.
[FR Doc. E8-19822 Filed 8-26-08; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 83, Number 29 (Monday, February 12, 2018)]
[Notices]
[Pages 6033-6034]
[FR Doc No: 2018-02761]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-E-2079]

Determination of Regulatory Review Period for Purposes of Patent
Extension; BRAVECTO

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) has
determined the regulatory review period for BRAVECTO and is publishing
this notice of that determination as required by law. FDA has made the
determination because of the submission of an application to the
Director of U.S. Patent and Trademark Office (USPTO), Department of
Commerce, for the extension of a patent which claims that animal drug
product.

DATES: Anyone with knowledge that any of the dates as published (see
the SUPPLEMENTARY INFORMATION section) are incorrect may submit either
electronic or written comments and ask for a redetermination by April
13, 2018. Furthermore, any interested person may petition FDA for a
determination regarding whether the applicant for extension acted with
due diligence during the regulatory review period by August 13, 2018.
See ``Petitions'' in the SUPPLEMENTARY INFORMATION section for more
information.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before April 13, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of April 13, 2018. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2015-E-2079 for ``Determination of Regulatory Review Period for
Purposes of Patent Extension; BRAVECTO.'' Received comments, those
filed in a timely manner (see ADDRESSES), will be placed in the docket
and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with Sec.  10.20 (21 CFR 10.20) and
other applicable disclosure law. For more information about FDA's
posting of comments to public dockets, see 80 FR 56469, September 18,
2015, or access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6250, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984
(Pub. L. 98-417) and the Generic Animal Drug and Patent Term
Restoration Act (Pub. L. 100-670) generally provide that a patent may
be extended for a period of up to 5 years so long as the patented item
(human drug product, animal drug product, medical device, food
additive, or color additive) was subject to regulatory review by FDA
before the item was marketed. Under these acts, a product's regulatory
review period forms the basis for determining the amount of extension
an applicant may receive.
    A regulatory review period consists of two periods of time: A
testing phase and an approval phase. For animal drug products, the
testing phase begins on the earlier date when either a major
environmental effects test was initiated for the drug or when an
exemption under section 512(j) of the Federal Food, Drug, and Cosmetic
Act (FD&C Act) (21

U.S.C. 360b(j)) became effective and runs until the approval phase
begins. The approval phase starts with the initial submission of an
application to market the animal drug product and continues until FDA
grants permission to market the drug product. Although only a portion
of a regulatory review period may count toward the actual amount of
extension that the Director of USPTO may award (for example, half the
testing phase must be subtracted as well as any time that may have
occurred before the patent was issued), FDA's determination of the
length of a regulatory review period for an animal drug product will
include all of the testing phase and approval phase as specified in 35
U.S.C. 156(g)(4)(B).
    FDA has approved for marketing the animal drug product BRAVECTO
(fluralaner). BRAVECTO is indicated for treatment and control of flea
infestations (Ctenocephalides felis), and the treatment and control of
tick infestations (Ixodes scapularis (black legged tick), Dermacentor
variabilis (American dog tick), and Rhipicephalus sanguineus (brown dog
tick)) for 12 weeks in dogs and puppies 6 months of age and older, and
weighing 4.4 pounds or greater. It is also indicated for the treatment
and control of Amblyomma americanum (lone star tick) infestations for 8
weeks in dogs and puppies 6 months of age and older and weighing 4.4
pounds or greater. Subsequent to this approval, the USPTO received a
patent term restoration application for BRAVECTO (U.S. Patent No.
7,662,972) from Nissan Chemical Industries, Ltd., and the USPTO
requested FDA's assistance in determining this patent's eligibility for
patent term restoration. In a letter dated October 19, 2015, FDA
advised the USPTO that this animal drug product had undergone a
regulatory review period and that the approval of BRAVECTO represented
the first permitted commercial marketing or use of the product.
Thereafter, the USPTO requested that FDA determine the product's
regulatory review period.

II. Determination of Regulatory Review Period

    FDA has determined that the applicable regulatory review period for
BRAVECTO is 1,017 days. Of this time, 979 days occurred during the
testing phase of the regulatory review period, while 38 days occurred
during the approval phase. These periods of time were derived from the
following dates:
    1. The date an exemption under section 505(i) of the FD&C Act (21
U.S.C. 355(i)) became effective: August 4, 2011. The applicant claims
February 19, 2010, as the date the investigational new animal drug
application (INAD) became effective. However, FDA records indicate that
the INAD effective date was August 4, 2011, which was the date a major
health or environmental effects test was begun or the date on which the
Agency acknowledged the filing of a notice of claimed investigational
exemption for a new animal drug, whichever was earlier.
    2. The date the application was initially submitted with respect to
the animal drug product under section 512 of the FD&C Act: April 8,
2014. FDA has verified the applicant's claim that the new animal drug
application (NADA) for BRAVECTO (NADA 141-426) was submitted on April
8, 2014.
    3. The date the application was approved: May 15, 2014. FDA has
verified the applicant's claim that NADA 141-426 was approved on May
15, 2014.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the USPTO
applies several statutory limitations in its calculations of the actual
period for patent extension. In its application for patent extension,
this applicant seeks 792 days of patent term extension.

III. Petitions

    Anyone with knowledge that any of the dates as published are
incorrect may submit either electronic or written comments and, under
21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as
specified in Sec.  60.30 (21 CFR 60.30), any interested person may
petition FDA for a determination regarding whether the applicant for
extension acted with due diligence during the regulatory review period.
To meet its burden, the petition must comply with all the requirements
of Sec.  60.30, including but not limited to: Must be timely (see
DATES), must be filed in accordance with Sec.  10.20, must contain
sufficient facts to merit an FDA investigation, and must certify that a
true and complete copy of the petition has been served upon the patent
applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42,
1984.) Petitions should be in the format specified in 21 CFR 10.30.
    Submit petitions electronically to https://www.regulations.gov at
Docket No. FDA-2013-S-0610. Submit written petitions (two copies are
required) to the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Dated: February 7, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-02761 Filed 2-9-18; 8:45 am]
 BILLING CODE 4164-01-P