[Federal Register Volume 79, Number 145 (Tuesday, July 29, 2014)]
[Rules and Regulations]
[Page 43938]
[FR Doc No: 2014-17849]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2014-0584]

Drawbridge Operation Regulation; Hutchinson River, Bronx, NY

AGENCY: Coast Guard, DHS.

ACTION: Notice of deviation from drawbridge regulation.

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SUMMARY: The Coast Guard has issued a temporary deviation from the
operating schedule that governs the Amtrak Pelham Bay Bridge across the
Hutchinson River, mile 0.5, at Bronx, New York. The deviation is
necessary for installation of new bearing bushings at the bridge. This
temporary deviation allows the bridge to remain in the closed position
for two six-day closure periods to perform scheduled maintenance.

DATES: This deviation is effective from 10 p.m. on October 10, 2014
through 7 a.m. on October 30, 2014.

ADDRESSES: The docket for this deviation, [USCG-2014-0584] is available
at http://www.regulations.gov. Type the docket number in the ``SEARCH''
box and click ``SEARCH.'' Click on Open Docket Folder on the line
associated with this deviation. You may also visit the Docket
Management Facility in Room W12-140, on the ground floor of the
Department of Transportation West Building, 1200 New Jersey Avenue SE.,
Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this
temporary deviation, call or email Ms. Judy Leung-Yee, Project Officer,
First Coast Guard District<EMAIL_ADDRESS>or (212) 668-
7165. If you have questions on viewing the docket, call Cheryl Collins,
Program Manager, Docket Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:
    The Amtrak Pelham Bay Bridge has a vertical clearance of 8 feet at
mean high water and 15 feet at mean low water. The existing drawbridge
operating regulations are found at 33 CFR 117.793.
    The Hutchinson River has predominantly commercial vessel traffic of
various sizes.
    The owner of the bridge, National Railroad Passenger Corporation
(Amtrak), requested two six-day bridge closures to facilitate
installation of new bearing bushings at the bridge.
    Under this temporary deviation, the Amtrak Pelham Bay Bridge may
remain in the closed position from 10 p.m. on October 10, 2014 through
7 a.m. on October 16, 2014 and from 10 p.m. on October 17, 2014 through
7 a.m. on October 23, 2014. In the event of inclement weather a rain
date from 10 p.m. on October 24, 2014 through 7 a.m. on October 30,
2014 will be used to complete the scheduled bridge maintenance.
    The Coast Guard coordinated this bridge closure with the existing
marine facilities that normally transit the Amtrak Pelham Bay Bridge
and no objections were received.
    Vessels that can pass under the bridge in the closed position may
do so at all times. There are no alternate routes. The bridge can't be
opened in the event of an emergency during this bridge maintenance.
    In accordance with 33 CFR 117.35(e), the drawbridge must return to
its regular operating schedule immediately at the end of the effective
period of this temporary deviation. This deviation from the operating
regulations is authorized under 33 CFR 117.35.

    Dated: July 17, 2014.
C.J. Bisignano,
Supervisory Bridge Management Specialist, First Coast Guard District.
[FR Doc. 2014-17849 Filed 7-28-14; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 88, Number 182 (Thursday, September 21, 2023)]
[Notices]
[Pages 65200-65202]
[FR Doc No: 2023-20403]

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DEPARTMENT OF LABOR

Occupational Safety and Health Administration

[Docket No. OSHA-2007-0039]

Intertek Testing Services NA, Inc.: Grant of Expansion of
Recognition

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

ACTION: Notice.

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SUMMARY: In this notice, OSHA announces the final decision to expand
the scope of recognition for Intertek Testing Services NA, Inc., as a
Nationally Recognized Testing Laboratory (NRTL).

DATES: The expansion of the scope of recognition becomes effective on
September 21, 2023.

FOR FURTHER INFORMATION CONTACT: Information regarding this notice is
available from the following sources:
    Press inquiries: Contact Mr. Frank Meilinger, Director, OSHA Office
of Communications, U.S. Department of Labor, telephone:<PHONE_NUMBER>;
email: [email protected].
    General and technical information: Contact Mr. Kevin Robinson,
Director, Office of Technical Programs and Coordination Activities,
Directorate of Technical Support and Emergency Management, Occupational
Safety and Health Administration, U.S. Department of Labor, phone:
(202) 693-2300 or email: [email protected].

SUPPLEMENTARY INFORMATION:

I. Notice of Final Decision

    OSHA hereby gives notice of the expansion of the scope of
recognition of Intertek Testing Services NA, Inc. (ITSNA) as a NRTL.
ITSNA's expansion covers the addition of 23 test sites to its NRTL
scope of recognition.
    OSHA recognition of a NRTL signifies that the organization meets
the requirements specified in 29 CFR 1910.7. Recognition is an
acknowledgment that the organization can perform independent safety
testing and certification of the specific products covered within the
scope of recognition. Each NRTL's scope of recognition includes (1) the
type of products the NRTL may test, with each type specified by the
applicable test standard and (2) the recognized site(s) that has/have
the technical capability to perform the product-testing and product-
certification activities for test standards within the NRTL's scope.
Recognition is not a delegation or grant of government authority;
however, recognition enables employers to use products approved by the
NRTL to meet OSHA standards that require product testing and
certification.
    The agency processes applications by a NRTL for initial
recognition, as well as for an expansion or renewal of recognition,
following requirements in Appendix A to 29 CFR 1910.7. This appendix
requires that the agency publish two notices in the Federal Register in
processing an application. In the first notice, OSHA announces the
application and provides the preliminary finding. In the second notice,
the agency provides the final decision on the application. These
notices set forth the NRTL's scope of recognition or modifications of
that

scope. OSHA maintains an informational web page for each NRTL,
including ITSNA, which details that NRTL's scope of recognition. These
pages are available from the OSHA website at http://www.osha.gov/dts/otpca/nrtl/index.html.
    ITSNA submitted an application, dated January 25, 2021 (OSHA-2007-
0039-0047), requesting the conversion of 23 existing Satellite
Notification Acceptance Program (SNAP) sites to recognized sites under
the NRTL Policy for Transitioning to Satellite Notification and
Acceptance Program Termination (SNAP Transition Policy) published in
the Federal Register on November 24, 2020 (85 FR 75042), as amended by
a June 22, 2022 Memorandum from James S. Frederick, Deputy Assistant
Secretary for Occupational Safety and Health, to Regional
Administrators and Executive Staff, titled ``Second Revision to the
Nationally Recognized Testing Laboratory (NRTL) Policy for
Transitioning to Satellite Notification and Acceptance Program (SNAP)
Termination.'' OSHA published the preliminary notice announcing ITSNA's
expansion application in the Federal Register on August 15, 2023 (88 FR
55476). The agency requested comments by August 30, 2023, but it
received no comments in response to this notice. OSHA is now proceeding
with this final grant of expansion of ITSNA's NRTL recognition.\1\
---------------------------------------------------------------------------

    \1\ In the preliminary notice, OSHA stated that ITSNA's
expansion application was dated December 18, 2020. However, OSHA
cited to the correct docket number, OSHA-2007-0039-0047, in that
notice, which indicates the correct date of January 25, 2021.
---------------------------------------------------------------------------

    To obtain or review copies of all public documents pertaining to
the ITSNA application, go to http://www.regulations.gov or contact the
Docket Office, Occupational Safety and Health Administration, U.S.
Department of Labor. Docket No. OSHA-2007-0039 contains all materials
in the record concerning ITSNA's recognition. All submissions,
including copyrighted material, are available for inspection through
the OSHA Docket Office. Contact the OSHA Docket Office at (202) 693-
2350 (TTY<PHONE_NUMBER>) for assistance in locating docket
submissions.

II. Final Decision and Order

    OSHA staff examined ITSNA's expansion applications, its capability
to meet the requirements of the test standards, and other pertinent
information. Based on its review of this evidence, OSHA finds that
ITSNA meets the requirements of 29 CFR 1910.7 for expansion of its
recognition, subject to the specified limitations and condition. OSHA
limits the expansion of ITSNA's recognition to include the 23 sites
listed in Table 1, below. This limitation is consistent with the
recognition that OSHA grants to other NRTLs that operate multiple
sites.

   Table 1--List of Test Sites for Inclusion in ITSNA's NRTL Scope of
                               Recognition
------------------------------------------------------------------------
        ITSNA site name                 Address              Country
------------------------------------------------------------------------
Columbus......................  1717 Arlingate Lane,    United States.
                                 Columbus, Ohio 43228.
Detroit.......................  45000 Helm Street--     United States.
                                 Suite 150, Plymouth
                                 Township, Michigan
                                 48170.
Grand Rapids..................  4700 Broadmoor SE--     United States.
                                 Suite 200, Kentwood,
                                 Michigan 49512.
Edmonton......................  14920 135 Ave.,         Canada.
                                 Edmonton, Alberta T5V
                                 1R9.
Montreal......................  1829 32nd Avenue,       Canada.
                                 Lachine, Quebec H8T
                                 3J1.
Toronto.......................  6225 Kenway Drive,      Canada.
                                 Mississauga, Ontario
                                 L5T 2L3.
Mexico City...................  Poniente 134 No. 660,   Mexico.
                                 Col. Industrial
                                 Vallejo, Mexico City,
                                 Azcapotzalco 02300.
Kaufbeuren....................  Innovapark 20,          Germany.
                                 Kaufbeuren, 87600.
Leatherhead...................  Cleeve Road,            United Kingdom.
                                 Leatherhead, Surrey
                                 KT22 7SA.
Milton Keynes.................  Davy Avenue,            United Kingdom.
                                 Knowlhill, Milton
                                 Keynes,
                                 Buckinghamshire MK5
                                 8NL.
Udine.........................  Via Principe di Udine   Italy.
                                 114, Campoformido,
                                 Udine 33030,.
Guangzhou.....................  Building E, Guangdong   China.
                                 Software Science
                                 Park, No. 7-2, Caipin
                                 Road, Science City--
                                 GETDD, Guangzhou,
                                 Guangdong 510663.
Hangzhou......................  4th Floor, Building     China.
                                 4#, No. 22, 22nd
                                 Street, Qiantang
                                 District Hangzhou,
                                 310018.
Shanghai Fengxian.............  Plant 5, No. 6958 Daye  China.
                                 Road, Fengxian
                                 District, Shanghai,
                                 201405.
Shanghai Qinzhou..............  No. 86, 1198 Qinzhou    China.
                                 Road North, Shanghai,
                                 200233.
Shenzhen......................  2F, Building B, No.     China.
                                 308 Wuhe Avenue,
                                 Zhangkengjing
                                 Community, GuanHu
                                 Subdistrict, LongHua
                                 District, Shenzhen,
                                 Guangdong 518067.
Shunde (Foshan)...............  Guangzhou Branch        China.
                                 Shunde Testing Site,
                                 Room 604, Block 5,
                                 Tianfulai
                                 International
                                 Industrial Park (the
                                 fifth phase), No. 3
                                 Changfu West Road,
                                 Ronggui Town, Shunde
                                 District, Foshan
                                 City, Guangdong
                                 Province.
Mumbai........................  ``F Wing'' Tex Centre,  India.
                                 Chandivali Farm Road,
                                 Andheri (East),
                                 Mumbai, Maharashtra--
                                 400072.
New Delhi.....................  E-20 & E26 Block B1,    India.
                                 Mohan Cooperative
                                 Industrial Area,
                                 Mathura Road, New
                                 Delhi, 110044.
Tokyo.........................  Yasuda Shibaura No.2    Japan.
                                 Bldg. 4F, 3-2-12,
                                 Kaigan, Minato-ku,
                                 Tokyo 108-0022.
Seoul.........................  3, Gongdan-ro 160beon-  South Korea.
                                 gil, Intertek
                                 Building, Gunpo-si,
                                 Gyeonggi-do 15845.
Bangkok.......................  1285/5 Prachachuen      Thailand.
                                 Road, Wong Sawang,
                                 Bangsue, Bangkok
                                 10800.
Taipei........................  5F, No. 423, Ruiguang   Taiwan.
                                 Road, Neihu District,
                                 Taipei, 114690.
------------------------------------------------------------------------

A. Conditions

    In addition to those conditions already required by 29 CFR 1910.7,
ITSNA must abide by the following conditions of the recognition:
    1. ITSNA must inform OSHA as soon as possible, in writing, of any
change of ownership, facilities, or key personnel, and of any major
change in its operations as a NRTL, and provide details of the
change(s);
    2. ITSNA must meet all the terms of its recognition and comply with
all OSHA policies pertaining to this recognition; and
    3. ITSNA must continue to meet the requirements for recognition,
including all previously published conditions on ITSNA's scope of
recognition, in all areas for which it has recognition.
    Pursuant to the authority in 29 CFR 1910.7, OSHA hereby expands the
scope of recognition of ITSNA as a NRTL, subject to the limitations and
conditions specified above.

III. Authority and Signature

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

    Signed at Washington, DC.
James S. Frederick,
Deputy Assistant Secretary of Labor for Occupational Safety and Health.
[FR Doc. 2023-20403 Filed 9-20-23; 8:45 am]
BILLING CODE 4510-26-P


[Federal Register Volume 78, Number 175 (Tuesday, September 10, 2013)]
[Notices]
[Pages 55310-55312]
[FR Doc No: 2013-21931]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-70313; File No. SR-CBOE-2013-085]

Self-Regulatory Organizations; Chicago Board Options Exchange,
Incorporated; Notice of Filing and Immediate Effectiveness of a
Proposed Rule Change To Amend the Fees Schedule

September 4, 2013.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on August 22, 2013, Chicago Board Options Exchange, Incorporated
(the ``Exchange'' or ``CBOE'') filed with the Securities and Exchange
Commission (the ``Commission'') the proposed rule change as described
in Items I, II, and III below, which Items have been prepared by the
Exchange. The Commission is publishing this notice to solicit comments
on the proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to amend its Fees Schedule. The text of the
proposed rule change is available on the Exchange's Web site (http://www.cboe.com/AboutCBOE/CBOELegalRegulatoryHome.aspx), at the Exchange's
Office of the Secretary, and at the Commission's Public Reference Room.

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

    In its filing with the Commission, the Exchange included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the

proposed rule change. The text of these statements may be examined at
the places specified in Item IV below. The Exchange has prepared
summaries, set forth in sections A, B, and C below, of the most
significant aspects of such statements.

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

1. Purpose
    The Exchange proposes to exclude the Russell 2000 Index (``RUT'')
from the Exchange's Volume Incentive Program (``VIP''). This would mean
that RUT volume would not be included in the calculations used for
determining VIP, nor would the Exchange pay out a credit for RUT
trades. The reason for this proposed change is due to changing economic
circumstances regarding RUT (including changed license fees (which are
lower than those offered by other exchanges) \3\ and other effects of
the new RUT licensing structure). The changed licensing structure for
RUT makes it less economically feasible to include RUT in the VIP.
Further, CBOE's competitive offering for RUT, including the trading of
RUT over CBOE's Complex Order Book and the assessment of the Marketing
Fee for RUT transactions \4\ as well as other economic circumstances
regarding the trading of RUT, has caused CBOE to gain such market share
that CBOE has deemed it unnecessary to offer the VIP's incentives in
order to attract RUT volume (the purpose of the VIP is to attract
volume via offering volume-based incentives). Unlike for other
multiply-listed indexes traded at CBOE that are still included in the
VIP, CBOE's competitive offering regarding RUT offers enough incentives
to market participants wishing to trade RUT that including RUT in the
VIP is unnecessary.
---------------------------------------------------------------------------

    \3\ See SR-CBOE-2013-83, which increases the Exchange's RUT
Surcharge Fee to $0.30 per contract, compared to SR-NYSEMKT-2013-65,
which increased the NYSE MKT LLC (``AMEX'') Royalty Fee for RUT from
$0.15 per contract to $0.40 per contract.
    \4\ See CBOE Fees Schedule, Marketing Fee table.
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2. Statutory Basis
    The Exchange believes the proposed rule change is consistent with
the Securities Exchange Act of 1934 (the ``Act'') and the rules and
regulations thereunder applicable to the Exchange and, in particular,
the requirements of Section 6(b) of the Act.\5\ Specifically, the
Exchange believes the proposed rule change is consistent with Section
6(b)(4) of the Act,\6\ which provides that Exchange rules may provide
for the equitable allocation of reasonable dues, fees, and other
charges among its TPHs and other persons using its facilities.
---------------------------------------------------------------------------

    \5\ 15 U.S.C. 78f(b).
    \6\ 15 U.S.C. 78f(b)(4).
---------------------------------------------------------------------------

    The Exchange believes that excluding RUT from the VIP is reasonable
because the VIP is a credit program, and excluding RUT from the VIP
does not impose any extra fee for RUT trades, it just prevents them
from incurring a credit (or counting towards incurring credits). As
such, qualifying market participants trading RUT will merely be
required to pay regular transaction fees. The Exchange believes that
excluding RUT from the VIP is equitable and not unfairly discriminatory
because the different licensing schemes for RUT (and all licensed
products) make such products incomparable, and the changed licensing
structure for RUT makes it less economically feasible to include RUT in
the VIP. Further, CBOE's competitive offering for RUT, including the
trading of RUT over CBOE's Complex Order Book and the assessment of the
Marketing Fee for RUT transactions \7\ as well as other economic
circumstances regarding the trading of RUT, has caused CBOE to gain
such market share that CBOE has deemed it unnecessary to offer the
VIP's incentives in order to attract RUT volume (the purpose of the VIP
is to attract volume via offering volume-based incentives). Unlike for
other multiply-listed indexes traded at CBOE that are still included in
the VIP, CBOE's competitive offering regarding RUT offers enough
incentives to market participants wishing to trade RUT that including
RUT in the VIP is unnecessary.
---------------------------------------------------------------------------

    \7\ See CBOE Fees Schedule, Marketing Fee table.
---------------------------------------------------------------------------

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

    CBOE does not believe that the proposed rule change will impose any
burden on competition that is not necessary or appropriate in
furtherance of the purposes of the Act. The Exchange does not believe
that excluding RUT from the VIP will impose any burden on intramarket
competition that is not necessary or appropriate in furtherance of the
purposes of the Act because the proposed change does not affect to whom
the VIP applies. Further, the different licensing schemes for RUT (and
all licensed products) make such products incomparable, and the changed
licensing structure for RUT makes it less economically feasible to
include RUT in the VIP. The Exchange does not believe that excluding
RUT from the VIP is will impose any burden on intermarket competition
that is not necessary or appropriate in furtherance of the purposes of
the Act because this exclusion only applies to trading on CBOE, and the
VIP only applies to CBOE.

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

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

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A) of the Act \8\ and paragraph (f) of Rule 19b-4 \9\
thereunder. At any time within 60 days of the filing of the proposed
rule change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission will institute proceedings to
determine whether the proposed rule change should be approved or
disapproved.
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    \8\ 15 U.S.C. 78s(b)(3)(A).
    \9\ 17 CFR 240.19b-4(f).
---------------------------------------------------------------------------

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-CBOE-2013-085 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-CBOE-2013-085. This file
number should be included on the subject line if email is used. To help
the

Commission process and review your comments more efficiently, please
use only one method. The Commission will post all comments on the
Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml).
Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for Web site viewing and printing in
the Commission's Public Reference Room, 100 F Street NE., Washington DC
20549, on official business days between the hours of 10:00 a.m. and
3:00 p.m. Copies of such filing also will be available for inspection
and copying at the principal offices of the Exchange. All comments
received will be posted without change; the Commission does not edit
personal identifying information from submissions. You should submit
only information that you wish to make available publicly. All
submissions should refer to File Number SR-CBOE-2013-085, and should be
submitted on or before October 1, 2013.
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    \10\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\10\
Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2013-21931 Filed 9-9-13; 8:45 am]
BILLING CODE 8011-01-P


41131 Federal Register / Vol. 68, No. 132 / Thursday, July 10, 2003 / Notices Davis Highway, Arlington, VA. The telephone number is ( 703) 418   6800. The Hilton Crystal City is a 5   minute walk from the Crystal City Metro Station and about a 10 minute taxi ride from National Airport. FOR FURTHER INFORMATION CONTACT: Margie Fehrenbach, Office of Pesticide Programs, Mail code 7501C, Environmental Protection Agency, 1200 Pennsylvania Avenue, NW., Washington, DC 20460; telephone number: 703   308   4775; fax number: 703   308   4776; e mail address: Fehrenbach. Margie@ epa. gov.

SUPPLEMENTARY INFORMATION:

I. General Information A. Does this Action Apply to Me? This action is directed to the public in general; however, persons may be interested who work in agricultural settings or persons who are concerned about implementation of the Federal Insecticide, Fungicide, and Rodenticide Act ( FIFRA); the Federal Food, Drug, and Cosmetic Act ( FFDCA); and the amendments to both of these major pesticide laws by the Food Quality Protection Act ( FQPA) of 1996. Since other entities may also be interested, the Agency has not attempted to describe all the specific entities that may be affected by this action. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT. Potentially affected entities may include but are not limited to: Agricultural workers and farmers; pesticide industry and trade associations; environmental, consumer and farmworker groups; pesticide users and growers; pest consultants; State, local and Tribal governments; academia; public health organizations; food processors; and the public. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT.

B. How Can I Get Copies of this Document and Other Related Information? 1. Docket. EPA has established an official public docket for this action under docket identification ( ID) number OPP   2003   0247. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although a part of the official docket, the public docket does not include Confidential Business Information ( CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the Public Information and Records Integrity Branch ( PIRIB), Rm. 119, Crystal Mall # 2, 1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open from 8: 30 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The docket telephone number is ( 703) 305   5805. 2. Electronic access. You may access this Federal Register document electronically through the EPA Internet under the `` Federal Register'' listings at http:// www. epa. gov/ fedrgstr/. An agenda has been developed and is posted on EPA's website at www. epa. gov/ pesticides/ carat. An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at http:// www. epa. gov/ edocket/ to view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I. B. 1. Once in the system, select `` search,'' then key in the appropriate docket ID number.

II. Background The Committee to Advise on Reassessment and Transition ( CARAT) was established in accordance with the Federal Advisory Committee Act to provide advice and counsel to the Administrator of EPA and the Secretary of Agriculture regarding strategic approaches for pest management planning and tolerance reassessment for pesticides as required by the Food Quality Protection Act of 1996 ( FQPA). Through CARAT, EPA and the USDA are working together to ensure smooth implementation of FQPA through use of sound science, consultation with stakeholders, increased transparency, and reasonable transition for agriculture. CARAT is composed of a balanced group of participants from the following sectors: Pesticide user, grower and commodity groups; industry and trade associations; food processors and distributors; environmental/ public interest and farmworker groups; Federal, State and Tribal governments; public health organizations; and academia. The CARAT Work Group on Transition was established to identify barriers to the development and adoption by users of new, safer and effective pest management techniques and to formulate recommendations for Federal agency actions that, in partnership with the range of stakeholders, will reduce or eliminate these barriers.

III. How Can I Request to Participate in this Meeting?

This meeting will be open to the public. Opportunity will be provided for questions and comments by the public. Any person who wishes to file a written statement may do so before or after the meeting. These statements will become part of the permanent record and will be available for public inspection at the address listed under Unit I. B. 1.

List of Subjects Environmental protection, Agricultural workers, Agriculture, Chemicals, Foods, Pesticides, Pests, Risk assessment.

Dated: July 7, 2003. James Jones, Director, Office of Pesticide Programs.

[ FR Doc. 03   17608 Filed 7   9   03; 8: 45 am]

BILLING CODE 6560   50   S ENVIRONMENTAL PROTECTION AGENCY [ OPP   2003   0252; FRL   7318   9]

Pesticide Program Dialogue Committee's Registration Review Work Group; Notice of Public Meeting AGENCY: Environmental Protection Agency ( EPA). ACTION: Notice.

SUMMARY: EPA's Office of Pesticide Programs will hold a public meeting of the Registration Review Work Group of the Pesticide Program Dialogue Committee ( PPDC) on July 16, 2003. The Registration Review Work Group was established as a forum to provide advice and recommendations to the PPDC regarding a registration review program that is efficient and fair to all stakeholders, focuses on risk reduction, and considers user needs for agricultural, non agricultural and public health pesticides. Under section 3( g) of the Federal Insecticide, Fungicide, and Rodenticide Act, EPA must publish procedures for reviewing the registration of pesticides every 15 years. DATES: The meeting will be held on Wednesday, July 16, 2003, from 9 a. m. to 5 p. m. ADDRESSES: The meeting will be held at the Sheraton Crystal City, 1800 Jefferson Davis Highway, Arlington, VA. The telephone number is ( 703) 486   1111.

VerDate Jan< 31> 2003 16: 23 Jul 09, 2003 Jkt 200001 PO 00000 Frm 00023 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 10JYN1. SGM 10JYN1 41132 Federal Register / Vol. 68, No. 132 / Thursday, July 10, 2003 / Notices The Sheraton Crystal City is one block from the Crystal City Metro Station. FOR FURTHER INFORMATION: Margie Fehrenbach, Office of Pesticide Programs, Mail code 7501C, Environmental Protection Agency, 1200 Pennsylvania Avenue, NW., Washington, DC 20460; telephone number: 703   308   4775; fax number: 703   308   4776; e mail address: Fehrenbach. Margie@ epa. gov.

SUPPLEMENTARY INFORMATION:

I. General Information A. Does this Action Apply to Me? This action is directed to the public in general; however, persons may be interested who work in agricultural settings or persons who are concerned about implementation of the Federal Insecticide, Fungicide, and Rodenticide Act ( FIFRA); the Federal Food, Drug, and Cosmetic Act ( FFDCA); and the amendments to both of these major pesticide laws by the Food Quality Protection Act ( FQPA) of 1996. Since other entities may also be interested, the Agency has not attempted to describe all the specific entities that may be affected by this action. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT. Potentially affected entities may include but are not limited to: Agricultural workers and farmers; pesticide industry and trade associations; environmental, consumer and farmworker groups; pesticide users and growers; pest consultants; State, local and Tribal governments; academia; public health organizations; food processors; and the public. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT.

B. How Can I Get Copies of this Document and Other Related Information? 1. Docket. EPA has established an official public docket for this action under docket identification ( ID) number OPP   2003   0252. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although a part of the official docket, the public docket does not include Confidential Business Information ( CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the Public Information and Records Integrity Branch ( PIRIB), Rm. 119, Crystal Mall # 2, 1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open from 8: 30 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The docket telephone number is ( 703) 305   5805. 2. Electronic access. You may access this Federal Register document electronically through the EPA Internet under the `` Federal Register'' listings at http:// www. epa. gov/ fedrgstr/. An agenda has been developed and is posted on EPA's website at www. epa. gov/ pesticides/ ppdc. An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at http:// www. epa. gov/ edocket/ to view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I. B. 1. Once in the system, select `` search,'' then key in the appropriate docket ID number.

II. Background The PPDC is composed of 42 members appointed by EPA's Deputy Administrator. Committee members were selected from a balanced group of participants from the following sectors: Pesticide user, grower and commodity groups; industry and trade associations; environmental/ public interest and farmworker groups; Federal, State and Tribal governments; public health organizations; animal welfare; and academia. PPDC was established to provide a public forum to discuss a wide variety of pesticide regulatory development and reform initiatives, evolving public policy, program implementation issues, and science policy issues associated with evaluating and reducing risks from use of pesticides. PPDC's Registration Review Work Group was recently established and is comprised of 22 members with balanced representation from the broad group of stakeholders. The Registration Review Work Group is Chaired by Jay Ellenberger, Acting Director, Field and External Affairs Division, Office of Pesticide Programs, and Betty Shackleford, Acting Director, Special Review and Reregistration Division, Office of Pesticide Programs. III. How Can I Request to Participate in this Meeting?

This meeting will be open to the public. Opportunity will be provided for questions and comments by the public. Any person who wishes to file a written statement may do so before or after the meeting. These statements will become part of the permanent record and will be available for public inspection at the address listed under Unit I. B. 1.

List of Subjects Environmental protection, Agriculture, Agricultural workers, Chemicals, Foods, Inert Ingredients, Pesticides, Pests, Registration, Risk assessment.

Dated: July 7, 2003. James Jones, Director, Office of Pesticide Programs.

[ FR Doc. 03   17607 Filed 7   9   03; 8: 45 am]

BILLING CODE 6560   50   S ENVIRONMENTAL PROTECTION AGENCY [ FRL   7527   1]

Science Advisory Board; Air Toxics Research Strategy/ Multi Year Plan Review Panel; Notification of An Upcoming Public Meeting AGENCY: Environmental Protection Agency ( EPA). ACTION: Notice.

SUMMARY: The EPA's Science Advisory Board ( SAB) is announcing a public meeting of the Air Toxics Research Strategy/ Multi Year Plan Review ( Panel) to conduct a review of the Agency's Air Toxics Research Strategy/ Multi Year Plan.

DATES: July 23   24, 2003   The public meeting for the SAB Panel will begin at 9 am and adjourn no later than 5: 30 pm ( Eastern Time) each day. The meeting agenda and final charge questions will be posted on the SAB Web site http:// www. epa. gov/ sab/ agendas. htm one week before the meeting. ADDRESSES: The public meeting of the Panel will be held at the U. S. Environmental Protection Agency ( EPA), 109 T. W. Alexander Drive, Research Triangle Park, North Carolina 27709. The room number is C111   C for July 23 and C111   B for July 24. For further information concerning the public meeting, please contact Dr. James Rowe, Designated Federal Officer ( DFO) ( see contact information below).

FOR FURTHER INFORMATION CONTACT: Any member of the public wishing further VerDate Jan< 31> 2003 16: 23 Jul 09, 2003 Jkt 200001 PO 00000 Frm 00024 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 10JYN1. SGM 10JYN1


[Federal Register Volume 78, Number 194 (Monday, October 7, 2013)]
[Notices]
[Page 61941]
[FR Doc No: 2013-24376]

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Notices
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains documents other than rules
or proposed rules that are applicable to the public. Notices of hearings
and investigations, committee meetings, agency decisions and rulings,
delegations of authority, filing of petitions and applications and agency
statements of organization and functions are examples of documents
appearing in this section.

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

Federal Register / Vol. 78, No. 194 / Monday, October 7, 2013 /
Notices

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:

Filings Instituting Proceedings

    Docket Numbers: RP13-1347-000.
    Applicants: Enable Mississippi River Transmission, L.
    Description: ACA Compliance Filing to be effective 10/1/2013.
    Filed Date: 9/25/13.
    Accession Number: 20130925-5055.
    Comments Due: 5 p.m. e.t. 10/7/13.

    Docket Numbers: RP13-1348-000.
    Applicants: National Fuel Gas Supply Corporation.
    Description: Appalachian Pooling Filing (GT&C Sec 13.1) to be
effective 11/1/2013.
    Filed Date: 9/26/13.
    Accession Number: 20130926-5092.
    Comments Due: 5 p.m. e.t. 10/8/13.

    Docket Numbers: RP13-1349-000.
    Applicants: Natural Gas Pipeline Company of America.
    Description: EDF Negotiated Rate to be effective 10/1/2013.
    Filed Date: 9/26/13.
    Accession Number: 20130926-5093.
    Comments Due: 5 p.m. e.t. 10/8/13.

    Docket Numbers: RP13-1350-000.
    Applicants: Maritimes & Northeast Pipeline, L.L.C.
    Description: MNUS FRQ 2013 to be effective 11/1/2013.
    Filed Date: 9/26/13.
    Accession Number: 20130926-5104.
    Comments Due: 5 p.m. e.t. 10/8/13.

    Docket Numbers: RP13-1351-000.
    Applicants: Texas Eastern Transmission, LP.
    Description: ConocoPhillips 10-1-2013 releases to be effective 10/
1/2013.
    Filed Date: 9/27/13.
    Accession Number: 20130927-5030.
    Comments Due: 5 p.m. e.t. 10/9/13.

    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.

Filings in Existing Proceedings

    Docket Numbers: RP11-2061-006.
    Applicants: Northern Natural Gas Company.
    Description: 20130926 Reservation Charge Credits Compliance to be
effective 12/20/2012.
    Filed Date: 9/26/13.
    Accession Number: 20130926-5031.
    Comments Due: 5 p.m. e.t. 10/8/13.

    Docket Numbers: RP13-1312-000.
    Applicants: Millennium Pipeline Company, LLC.
    Description: Withdrawal Request of Negotiate Rate SVC Agreement--
Contract No. 142902.
    Filed Date: 9/26/13.
    Accession Number: 20130926-5105.
    Comments Due: 5 p.m. e.t. 10/8/13.

    Docket Numbers: RP12-245-003.
    Applicants: TransColorado Gas Transmission Company L.
    Description: Second Compliance Filing--Reservation Charge Credits
to be effective 6/16/2012.
    Filed Date: 9/27/13.
    Accession Number: 20130927-5002.
    Comments Due: 5 p.m. e.t. 10/9/13.

    Any person desiring to protest in any of the above proceedings must
file in accordance with Rule 211 of the Commission's Regulations (18
CFR 385.211) on or before 5:00 p.m. Eastern time on the specified
comment date.
    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: September 27, 2013.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2013-24376 Filed 10-4-13; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 84, Number 241 (Monday, December 16, 2019)]
[Notices]
[Page 68438]
[FR Doc No: 2019-27016]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP20-19-000]

UGI Sunbury, LLC; Notice of Request Under Blanket Authorization

    Take notice that on December 3, 2019, UGI Sunbury, LLC (UGI
Sunbury), 835 Knitting Mills Way, Wyomissing, PA 19610, filed in the
above referenced docket a prior notice request pursuant to sections
157.205, 157.208, and 157.216 of the Commission's regulations under the
Natural Gas Act and its blanket certificate issued in Docket No. CP15-
525-000 for authorization to remove, construct, own, operate, and
maintain a one mile segment of the Sunbury Pipeline Project in Snyder
County, Pennsylvania. Specifically, UGI Sunbury states that it will
remove and relocate a portion of the Sunbury Pipeline Project to
accommodate a Pennsylvania Department of Transportation and Federal
Highway Administration project known as the Central Susquehanna Valley
Transportation Project. UGI Sunbury estimates the cost of the project
to be $12,500,000, all as more fully set forth in the application which
is on file with the Commission and open to public inspection.
    The filing may also be viewed on the web at http://www.ferc.gov
using the ``eLibrary'' link. Enter the docket number excluding the last
three digits in the docket number field to access the document. For
assistance, please contact FERC Online Support at
<EMAIL_ADDRESS>or toll free at<PHONE_NUMBER>, or TTY,
contact<PHONE_NUMBER>.
    Any questions concerning this application may be directed to Brett
Burch Project Manager, UGI Energy Services, LLC, 835 Knitting Mills
Way, Wyomissing, PA 19610, by telephone at<PHONE_NUMBER>, or by email
at<EMAIL_ADDRESS>    Any person or the Commission's staff may, within 60 days after
issuance of the instant notice by the Commission, file pursuant to Rule
214 of the Commission's Procedural Rules (18 CFR 385.214) a motion to
intervene or notice of intervention and pursuant to section 157.205 of
the regulations under the NGA (18 CFR 157.205), a protest to the
request. If no protest is filed within the time allowed therefore, the
proposed activity shall be deemed to be authorized effective the day
after the time allowed for filing a protest. If a protest is filed and
not withdrawn within 30 days after the allowed time for filing a
protest, the instant request shall be treated as an application for
authorization pursuant to section 7 of the NGA.
    Pursuant to section 157.9 of the Commission's rules (18 CFR 157.9),
within 90 days of this Notice, the Commission staff will either:
Complete its environmental assessment (EA) and place it into the
Commission's public record (eLibrary) for this proceeding; or issue a
Notice of Schedule for Environmental Review. If a Notice of Schedule
for Environmental Review is issued, it will indicate, among other
milestones, the anticipated date for the Commission staff's issuance of
the EA for this proposal. The filing of the EA in the Commission's
public record for this proceeding or the issuance of a Notice of
Schedule for Environmental Review will serve to notify federal and
state agencies of the timing for the completion of all necessary
reviews, and the subsequent need to complete all federal authorizations
within 90 days of the date of issuance of the Commission staff's EA.
    Persons who wish to comment only on the environmental review of
this project should submit an original and two copies of their comments
to the Secretary of the Commission. Environmental commenters will be
placed on the Commission's environmental mailing list, and will be
notified of any meetings associated with the Commission's environmental
review process. Environmental commenters will not be required to serve
copies of filed documents on all other parties. However, the non-party
commenters, will not receive copies of all documents filed by other
parties or issued by the Commission and will not have the right to seek
court review of the Commission's final order.
    The Commission strongly encourages electronic filings of comments,
protests, and interventions in lieu of paper using the ``eFiling'' link
at http://www.ferc.gov. Persons unable to file electronically should
submit an original and 3 copies of the protest or intervention to the
Federal Energy Regulatory Commission, 888 First Street NE, Washington,
DC 20426.

    Dated: December 10, 2019.
Kimberly D. Bose,
Secretary.
[FR Doc. 2019-27016 Filed 12-13-19; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 88, Number 47 (Friday, March 10, 2023)]
[Notices]
[Page 15116]
[FR Doc No: 2023-04914]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

[Docket No. FRA-2000-7257, Notice No. 93]

Railroad Safety Advisory Committee; Notice of Meeting

AGENCY: Federal Railroad Administration (FRA), Department of
Transportation (DOT).

ACTION: Notice of public meeting.

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

SUMMARY: FRA announces the sixty-fourth meeting of the Railroad Safety
Advisory Committee (RSAC), a Federal Advisory Committee that provides
advice and recommendations to FRA on railroad safety matters through a
consensus process. This special meeting of the RSAC will focus on the
events related to the February 3, 2023 freight train derailment in East
Palestine, Ohio, and include a discussion of potential related safety
improvements and possible RSAC tasks and actions.

DATES: The RSAC meeting is scheduled for Monday, March 27, 2023. The
meeting will commence at 9:30 a.m. and will adjourn by 4:30 p.m. (all
times Eastern Daylight Time). Requests to submit written materials to
be reviewed during the meeting must be received by March 17, 2023.
Requests for accommodations because of a disability must be received by
March 17, 2023.

ADDRESSES: The RSAC meeting will be held at the National Association of
Home Builders, located at 1201 15th Street NW, Washington, DC 20005. A
final agenda will be posted on the RSAC internet website at https://rsac.fra.dot.gov/ at least one week in advance of the meeting. Please
see the RSAC website for additional information on the committee at
https://rsac.fra.dot.gov/.

FOR FURTHER INFORMATION CONTACT: Kenton Kilgore, RSAC Designated
Federal Officer/RSAC Coordinator, FRA Office of Railroad Safety, (202)
365-3724 or [email protected]. Any committee-related request
should be sent to Mr. Kilgore.

SUPPLEMENTARY INFORMATION: Pursuant to section 10(a)(2) of the Federal
Advisory Committee Act (Pub. L. 92-463), FRA is giving notice of a
meeting of the RSAC. The RSAC is composed of 51 voting representatives
from 26 member organizations, representing various rail industry
perspectives. The diversity of the Committee ensures the requisite
range of views and expertise necessary to discharge its
responsibilities.
    Public Participation: The meeting is open to the public. Attendance
is on a first-come, first served basis, and is accessible to
individuals with disabilities. DOT and FRA are committed to providing
equal access to this meeting for all participants. If you need
alternative formats or services because of a disability, please contact
Mr. Kenton Kilgore as listed in the FOR FURTHER INFORMATION CONTACT
section and submit your request by March 17, 2023. Any member of the
public may submit a written statement to the committee at any time. If
a member of the public wants the submit written materials to be
reviewed by the committee during the meeting, it must be received by
March 17, 2023.
    Agenda Summary: This special meeting of the RSAC will focus on the
events leading up to, during, and following the February 3, 2023
Norfolk Southern Railway Co. freight train derailment in East
Palestine, Ohio, as well as suggested safety improvements, and possible
RSAC tasks and actions. A detailed agenda for the meeting will be
posted on the RSAC internet website at least one week in advance of the
meeting. Copies of the minutes of past meetings, along with general
information about the committee, are also available on the RSAC
internet website at https://rsac.fra.dot.gov/.

    Issued in Washington, DC.
Amitabha Bose,
Administrator.
[FR Doc. 2023-04914 Filed 3-9-23; 8:45 am]
BILLING CODE 4910-06-P


[Federal Register Volume 83, Number 99 (Tuesday, May 22, 2018)]
[Notices]
[Pages 23686-23688]
[FR Doc No: 2018-10924]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2017-M-3372, FDA-2017-M-3951, FDA-2017-M-3990, FDA-
2017-M-4022, FDA-2017-M-4271, FDA-2017-M-4498, FDA-2017-M-4756, FDA-
2017-M-4757, FDA-2017-M-4711, FDA-2017-M-4904, FDA-2017-M-5320, FDA-
2017-M-5262, FDA-2017-M-5334, FDA-2017-M-5438, FDA-2017-M-5813, FDA-
2017-M-5863, FDA-2017-M-5864, FDA-2017-M-5884, FDA-2017-M-5929, FDA-
2017-M-5969, FDA-2017-M-5968, FDA-2017-M-5997, FDA-2017-M-6223, FDA-
2017-M-6232, FDA-2017-M-6290, FDA-2017-M-6524, FDA-2017-M-6525, FDA-
2017-M-6550, FDA-2017-M-6614, FDA-2017-M-6650, FDA-2017-M-6799, FDA-
2017-M-6800, and FDA-2017-M-6896]

Medical Devices; Availability of Safety and Effectiveness
Summaries for Premarket Approval Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is publishing a list of
premarket approval applications (PMAs) that have been approved. This
list is intended to inform the public of the availability of safety and
effectiveness summaries of approved PMAs through the internet and the
Agency's Dockets Management Staff.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: httpss://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 Nos.
FDA-2017-M-3372, FDA-2017-M-3951, FDA-2017-M-3990, FDA-2017-M-4022,
FDA-2017-M-4271, FDA-2017-M-4498, FDA-2017-M-4756, FDA-2017-M-4757,
FDA-2017-M-4711, FDA-2017-M-4904, FDA-2017-M-5320, FDA-2017-M-5262,
FDA-2017-M-5334, FDA-2017-M-5438, FDA-2017-M-5813, FDA-2017-M-5863,
FDA-2017-M-5864, FDA-2017-M-5884, FDA-2017-M-5929, FDA-2017-M-5969,
FDA-2017-M-5968, FDA-2017-M-5997, FDA-2017-M-6223, FDA-2017-M-6232,
FDA-2017-M-6290, FDA-2017-M-6524, FDA-2017-M-6525, FDA-2017-M-6550,
FDA-2017-M-6614, FDA-2017-M-6650, FDA-2017-M-6799, FDA-2017-M-6800, and
FDA-2017-M-6896 for ``Medical Devices; Availability of Safety and
Effectiveness Summaries for Premarket Approval Applications.'' Received
comments 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 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: Joshua Nipper, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1650, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    In accordance with section 515(d)(4) and (e)(2) of the Federal
Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360e(d)(4) and
(e)(2)), notification of an order approving, denying, or withdrawing
approval of a PMA will continue to include a notice of opportunity to
request review of the order under section 515(g) of the FD&C Act. The
30-day period for requesting reconsideration of an FDA action under
Sec.  10.33(b) (21 CFR 10.33(b)) for notices announcing approval of a
PMA begins on the day the notice is placed on the internet. Section
10.33(b) provides that FDA may, for good cause, extend this 30-day
period. Reconsideration of a denial or withdrawal of approval of a PMA
may be sought only by the applicant; in these cases, the 30-day period
will begin when the applicant is notified by FDA in writing of its
decision.
    The regulations provide that FDA publish a list of available safety
and effectiveness summaries of PMA approvals and denials that were
announced during that quarter. The following is a list of approved PMAs
for which summaries of safety and effectiveness were placed on the
internet from July 1, 2017, through December 31, 2017. There were no
denial actions during this period. The list provides the manufacturer's
name, the product's generic name or the trade name, and the approval
date.

 Table 1--List of Safety and Effectiveness Summaries for Approved PMAs Made Available From July 1, 2017, Through
                                                December 31, 2017
----------------------------------------------------------------------------------------------------------------
          PMA No., Docket No.                   Applicant                    Trade name            Approval date
----------------------------------------------------------------------------------------------------------------
P160015, FDA-2017-M-3372..............  Zoll Medical Corporation.  AED Plus[supreg] and Fully          5/26/2017
                                                                    Automatic AED Plus[supreg].
P970003/S207, FDA-2017-M-3951.........  Cyberonics, Inc..........  VNS Therapy System...........       6/23/2017
P150048, FDA-2017-M-3990..............  Edwards Lifesciences, LLC  Edwards Pericardial Aortic          6/29/2017
                                                                    Bioprosthesis and Edwards
                                                                    INSPIRIS RESILIA Aortic
                                                                    Valve.
P930016/S048, FDA-2017-M-4022.........  AMO Manufacturing USA,     STAR S4 IR Excimer Laser            6/30/2017
                                         LLC.                       System and iDesign Advanced
                                                                    WaveScan Studio System.
P130021/S033, FDA-2017-M-4271.........  Medtronic CoreValve LLC..  Medtronic CoreValveTM System,       7/10/2017
                                                                    Medtronic CoreValveTM
                                                                    EvolutTM R System and
                                                                    Medtronic CoreValveTM
                                                                    EvolutTM PRO Systems.
P160049, FDA-2017-M-4498..............  Spectranetics Corp.......  Stellarex 0.035'' OTW Drug-         7/26/2017
                                                                    coated Angioplasty Balloon.
P170006, FDA-2017-M-4756..............  Medtronic, Inc...........  AvalusTM Bioprosthesis.......       7/31/2017
P170005, FDA-2017-M-4757..............  Abbott Molecular, Inc....  Abbott RealTime IDH2.........        8/1/2017
P160042, FDA-2017-M-4711..............  Prollenium Medical         Ravanesse Ultra..............        8/4/2017
                                         Technologies, Inc.
P030017/S275, FDA-2017-M-4904.........  Boston Scientific          PrecisionTM Spinal Cord             8/11/2017
                                         Neuromodulation            Stimulator System, Precision
                                         Corporation.               SpectraTM Spinal Cord
                                                                    Stimulator System,
                                                                    PrecisionTM NoviTM Spinal
                                                                    Cord Stimulator System,
                                                                    PrecisionTM MontageTM MRI
                                                                    Spinal Cord Stimulator
                                                                    System, PrecisionTM
                                                                    MontageTM Spinal Cord
                                                                    Stimulator System and
                                                                    Spectra WaveWriterTM Spinal
                                                                    Cord Stimulator System.
P160054, FDA-2017-M-5320..............  Thoratec Corporation.....  HeartMate 3TM Left                  8/23/2017
                                                                    Ventricular Assist System.
P140015/S020, FDA-2017-M-5262.........  Tandem Diabetes Care, Inc  t:slim X2 Insulin Pump with         8/25/2017
                                                                    Dexcom G5 Mobile CGM.
P170003, FDA-2017-M-5334..............  Lutonix, Inc.............  Lutonix[supreg] 035 Drug            8/25/2017
                                                                    Coated Balloon PTA Catheter,
                                                                    Model 9010.
P170007, FDA-2017-M-5438..............  Bioventus LLC............  DUROLANE[supreg].............       8/29/2017
P150025/S003, FDA-2017-M-5813.........  Dako North America, Inc..  PD-L1 IHC 28-8 pharmDx.......       9/15/2017
P150042, FDA-2017-M-5863..............  ZEUS Scientific, Inc.....  ZEUS ELISA Parvovirus B19 IgM       9/19/2017
                                                                    Test System.
P150045, FDA-2017-M-5864..............  ZEUS Scientific, Inc.....  ZEUS ELISA Parvovirus B19 IgG       9/19/2017
                                                                    Test System.
P170011, FDA-2017-M-5884..............  ABIOMED, Inc.............  Impella RP[supreg] System....       9/20/2017
P150013/S006, FDA-2017-M-5929.........  Dako North America, Inc..  PD-L1 IHC 22C3 pharmDx.......       9/22/2017
P160030, FDA-2017-M-5969..............  Abbott Diabetes Care, Inc  Freestyle Libre Flash Glucose       9/27/2017
                                                                    Monitoring System.
P100047/S090, FDA-2017-M-5968.........  Medtronic, Inc...........  HeartWareTM HVADTM System....       9/27/2017
P100021/S063, FDA-2017-M-5997.........  Medtronic Vascular.......  Endurant II/Endurant IIs            9/29/2017
                                                                    Stent Graft System.
P160039, FDA-2017-M-6223..............  Respicardia, Inc.........  remed[emacr][supreg] System..       10/6/2017
P170002, FDA-2017-M-6232..............  Teoxane S.A..............  RHA[supreg] 2, RHA[supreg] 3       10/19/2017
                                                                    and RHA[supreg] 4.
P150028/S001, FDA-2017-M-6290.........  NuMED, Inc...............  Cheatham Platinum (CP) Stent       10/24/2017
                                                                    System (Covered CP Stent,
                                                                    Model 427; Covered Mounted
                                                                    (CP) Stent, Model 428; CP
                                                                    Stent, Model 425; Mounted CP
                                                                    Stent, Model 426).
H020002/S046, FDA-2017-M-6524.........  Stryker Neurovascular....  Neuroform AtlasTM Stent             11/2/2017
                                                                    System.
P160057, FDA-2017-M-6525..............  OrthogenRx, Inc..........  TriVisc......................      11/13/2017
P160043/S001, FDA-2017-M-6550.........  Medtronic Vascular.......  Resolute OnyxTM Zotarolimus-       11/16/2017
                                                                    Eluting Coronary Stent
                                                                    System.
P160055, FDA-2017-M-6614..............  RxSight, Inc.............  Light Adjustable Lens (LAL)        11/22/2017
                                                                    and Light Delivery Device
                                                                    (LDD).
P170008, FDA-2017-M-6650..............  Medinol Ltd..............  EluNIR[supreg] Ridaforolimus       11/28/2017
                                                                    Eluting Coronary Stent
                                                                    System.
P170019, FDA-2017-M-6799..............  Foundation Medicine, Inc.  FoundationOne CDx............      11/30/2017

P150031, FDA-2017-M-6800..............  Boston Scientific          Vercise Deep Brain                  12/8/2017
                                         Corporation.               Stimulation (DBS) System.
P170012, FDA-2017-M-6896..............  Biom'Up SA...............  HEMOBLASTTM Bellows..........      12/15/2017
----------------------------------------------------------------------------------------------------------------

II. Electronic Access

    Persons with access to the internet may obtain the documents at
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/PMAApprovals/default.htm.

    Dated: May 17, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-10924 Filed 5-21-18; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 79, Number 137 (Thursday, July 17, 2014)]
[Notices]
[Pages 41709-41710]
[FR Doc No: 2014-16786]

=======================================================================
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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-72597; File No. SR-OCC-2014-12]

Self-Regulatory Organizations; The Options Clearing Corporation;
Order Approving Proposed Rule Change To Make Its Existing Policy
Concerning Specified Concentration Limits Related to Deposits of
Certain Letters of Credit Applicable to All Letters of Credit

July 11, 2014.

I. Introduction

    On May 20, 2014, the Options Clearing Corporation (``OCC'') filed
with the Securities and Exchange Commission (``Commission'') proposed
rule change SR-OCC-2014-12 pursuant to Section 19(b)(1) of the
Securities Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4
thereunder.\2\ The proposed rule change was published for comment in
the Federal Register on June 6, 2014.\3\ The Commission received no
comment letters in response to the proposed rule change. For the
reasons discussed below, the Commission is approving the proposed rule
change.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ Securities Exchange Act Release No. 72294 (June 2, 2014), 79
FR 32801 (June 6, 23, 2014) (SR-OCC-2014-12).
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II. Description

    OCC proposed to amend OCC Rule 604 in order to make its existing
policy concerning specified concentration limits related to deposits of
certain letters of credit (``LC'') applicable to all letters of credit.
Currently, OCC imposes concentration limits on clearing member margin
deposits of LCs issued by certain non-U.S. institutions.\4\
Specifically, OCC limits a clearing member's margin deposits of LCs
issued by such non-U.S. institutions to no more than 50% of a clearing
member's total margin deposit at any given time, and no more than 20%
of a clearing member's margin

deposit may include an LC issued by any one of these non-U.S.
institutions.\5\
---------------------------------------------------------------------------

    \4\ These concentration limits, however, are not currently
applied to LCs issued by non-U.S. institutions that qualify as
financial holding companies under Federal Reserve Board of Governors
Regulation Y or have an affiliate that is so qualified. See 17 CFR
225. In order to be deemed a financial holding company under
Regulation Y, among other things, the institution must make certain
certifications regarding the capitalization of the depository
institutions controlled by the holding company. See OCC Rule 604,
Interpretation and Policy .02. See also Securities Exchange Act
Release No. 5037 (November 6, 2001), 66 FR 57143 (November 14, 2001)
(SR-OCC-2001-03).
    \5\ Id.
---------------------------------------------------------------------------

    Pursuant to review and analysis performed by OCC's Risk Committee,
OCC is applying the existing concentration limits related to the
deposit of LCs, as set forth in OCC Rule 604, Interpretation and Policy
.02, applicable to all margin deposits of LCs regardless of issuer. As
a result of this change, no more than 50% of a clearing member's margin
on deposit may include LCs and no more than 20% of a clearing member's
margin may include an LC from a single issuer. This change is intended
to reduce OCC's overall credit risk exposure to LCs deposited as margin
by a single clearing member and the potential adverse consequences
should an LC issuer not perform upon its payment commitment after
receiving a demand for payment.
    OCC believes that the rule change will have a minimal impact on its
clearing members because LCs comprise less than one percent of OCC's
total margin deposits and are currently used by only 13 clearing
members. OCC estimates that the proposal will impact three clearing
members and .13% of OCC's total margin deposits. Each of these three
clearing members has been advised by OCC of the proposed change and OCC
stated that all of the affected clearing members have indicated that
they will be able to modify its margin deposit practices to reduce its
LC deposits without undue difficulty.
    OCC has indicated that prior to implementation of this rule change
it will publish an information memorandum to inform all clearing
members of the rule change. In addition, OCC stated that it contacted
clearing members with LCs on deposit that are directly affected by the
filing and all clearing members will have access to information, as
necessary, to better understand any potential impact the proposed rule
change may have on their margin deposits at OCC.

III. Discussion

    Section 19(b)(2)(C) of the Act \6\ directs the Commission to
approve a self-regulatory organization's proposed rule change if the
Commission finds that such proposed rule change is consistent with the
requirements of the Act and the rules and regulations thereunder
applicable to such organization. Section 17A(b)(3)(F) of the Act \7\
requires, among other things, that the rules of a clearing agency are
designed to promote the prompt and accurate clearance and settlement of
securities transactions and to the extent applicable derivative
agreements, contracts and transactions, and to assure the safeguarding
of securities and funds which are in the custody or control of the
clearing agency or for which it is responsible.
---------------------------------------------------------------------------

    \6\ 15 U.S.C. 78s(b)(2)(C).
    \7\ 15 U.S.C. 78q-1(b)(3)(F).
---------------------------------------------------------------------------

    The Commission finds that the proposed rule change to enhance
concentration limits related to deposits of LC and making those limits
applicable to all LC is consistent with Section 17A(b)(3)(F) of the
Act.\8\ The Commission believes the limitations on the concentration of
LC as margin deposits generally and the concentration of LCs by a
particular issuer should reduce the credit risk and settlement risk to
OCC associated with LCs as margin deposits by reducing the risk that an
LC issuer would not be able to provide funds to OCC to close out a
defaulting clearing member's positions. By reducing the risk that OCC
will not be able to use the deposited LC in the event of a clearing
member default, the limitations promote the prompt and accurate
clearance and settlement of securities transactions and other
transactions by OCC and help OCC assure the safeguarding of securities
and funds which are in its custody or control or for which it is
responsible.\9\
---------------------------------------------------------------------------

    \8\ 15 U.S.C. 78q-1(b)(3)(F).
    \9\ See id.
---------------------------------------------------------------------------

IV. Conclusion

    On the basis of the foregoing, the Commission concludes that the
proposal is consistent with the requirements of the Act, particularly
the requirements of Section 17A of the Act,\10\ and the rules and
regulations thereunder.
---------------------------------------------------------------------------

    \10\ 15 U.S.C. 78q-1.
---------------------------------------------------------------------------

    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\11\ that the proposed rule change (File No. SR-OCC-2014-12) be and
hereby is APPROVED.\12\
---------------------------------------------------------------------------

    \11\ 15 U.S.C. 78s(b)(2).
    \12\ In approving the proposed rule change, the Commission
considered the proposal's impact on efficiency, competition, and
capital formation. 15 U.S.C. 78c(f).

    For the Commission by the Division of Trading and Markets,
pursuant to delegated authority.\13\
---------------------------------------------------------------------------

    \13\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2014-16786 Filed 7-16-14; 8:45 am]
BILLING CODE 8011-01-P