[Federal Register Volume 76, Number 175 (Friday, September 9, 2011)]
[Notices]
[Pages 55986-55988]
[FR Doc No: 2011-23112]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-65251; File No. SR-BX-2011-060]

Self-Regulatory Organizations; NASDAQ OMX BX, Inc.; Notice of
Filing and Immediate Effectiveness of Proposed Rule Change Regarding a
Clarifying Amendment To Direct Connectivity Services

September 2, 2011.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that, on August 31, 2011, NASDAQ OMX BX, Inc. (the ``Exchange'') filed
with the Securities and Exchange Commission (``Commission'') the
proposed rule change as described in Items I, II, and III below, which
Items have been prepared by the 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 a clarifying amendment to Exchange Rule 7051
regarding the Exchange's direct connectivity services. The text of the
proposed rule change is available at http://nasdaqomxbx.cchwallstreet.com/, at the Exchange's principal office, 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 is amending Rule 7051 entitled ``Direct Connectivity
to BX'' to clarify the Exchange's direct connectivity services.
Currently, the Exchange assesses fees for direct 10Gb circuit
connections, and fees for direct circuit connections capable of
supporting up to 1Gb, for customers who are not co-located at the
Exchange's datacenter.\3\ The Exchange noted in SR-BX-2010-064 that it
makes available to both co-located and non-co-located customers direct
connections capable of supporting up to 1Gb, with per connection
monthly fees of $500 for co-located customers and $1000 for non co-
located customers.\4\ Monthly fees are higher for non co-located
customers because direct connection requires the Exchange to provide
cabinet space and middleware for those customers' third-party vendors
to connect to the datacenter and, ultimately, to the trading system.\5\
The Exchange also assesses an optional installation fee of $925 if the
customer chooses to use an on-site router (collectively ``Direct
Connectivity Fees'').\6\ The Exchange provides direct connect services
and assesses fees through NASDAQ Technology Services, LLC, as it does
with similar co-location services.\7\
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    \3\ See Securities Exchange Act Release No. 62969 (September 22,
2010), 75 FR 59777 (September 28, 2010) (SR-BX-2010-064).
    \4\ Id. at page 4 and page 10.
    \5\ Id.
    \6\ Id.
    \7\ See Exchange Rule 7034(b), Connectivity to BX.
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    Subsequently, the Exchange amended these Direct Connectivity Fees
to establish pricing for customers who are not co-located in the
Exchange's data center, but require shared cabinet space and power for
optional routers, switches, or modems to support their direct circuit
connections. The Exchange assesses customers who are not co-located in
the Exchange's data center monthly fees for space based on a height
unit of approximately two inches high, commonly call a ``U'' space and
a maximum power of 125 Watts per U space.\8\
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    \8\ See Securities Exchange Act Release No. 64439 (May 9, 2011),
76 FR 28248 (May 16, 2011) (SR-BX-2011-023).
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    The Exchange now seeks to add clarifying text to Exchange Rule 7051
to state that the direct connectivity services are provided by NASDAQ
Technology Services, LLC. The Exchange's proposal is the result of its
desire to prominently place language in the Exchange Rule 7051 to make
transparent that the connectivity services are provided by NASDAQ
Technology Services, LLC. Such change will assist with easy
identification of items not serviced, and billed, by the Exchange. This
change merely codifies the practice of the Exchange.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with the provisions of Section 6 of the Act,\9\ in general, and
furthers the objectives of Section 6(b)(5) of the Act \10\ in
particular, in that it is designed to promote just and equitable
principles of trade, to remove impediments to and perfect the mechanism
of a free and open market and a national market system, and, in general
to protect investors and the public interest. The Exchange believes the
proposed amendment to Exchange Rule 7051 makes transparent that the
direct connectivity services are provided by NASDAQ Technology
Services, LLC. The Exchange believes that this clarifying amendment
will benefit all market participants by making transparent the source
of the direct connectivity services.
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    \9\ 15 U.S.C. 78f.
    \10\ 15 U.S.C. 78f(b)(5).
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B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
result in any burden on competition that is not necessary or
appropriate in furtherance of the purposes of the Act.

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

    Written comments were neither solicited nor received.

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)(i) of the Act.\11\ At any time within 60 days of the filing
of the proposed rule change, the Commission summarily may temporarily
suspend such rule change if it appears to the Commission that such
action is necessary or appropriate in the public interest, for the
protection of investors, or otherwise in furtherance of the purposes of
the Act. If the Commission takes such action, the Commission shall
institute proceedings to determine whether the proposed rule should be
approved or disapproved.
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    \11\ 15 U.S.C. 78s(b)(3)(a)(i).
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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-BX-2011-060 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-BX-2011-060. 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 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
a.m. and 3 p.m. Copies of the filing also will be available for
inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-BX-2011-060 and should be
submitted on or before September 30, 2011.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\12\
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    \12\ 17 CFR 200.30-3(a)(12).
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Elizabeth M. Murphy,
Secretary .
[FR Doc. 2011-23112 Filed 9-8-11; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 79, Number 215 (Thursday, November 6, 2014)]
[Notices]
[Pages 65978-65979]
[FR Doc No: 2014-26306]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-D-0369, formerly 2007D-0168]

Bioequivalence Recommendations for CONCERTA (Methylphenidate
Hydrochloride) Extended-Release Tablets; Draft Guidance for Industry;
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance for industry entitled ``Bioequivalence
Recommendations for CONCERTA (methylphenidate hydrochloride) Extended-
Release Tablets.'' The recommendations provide specific guidance on the
design of bioequivalence (BE) studies to support abbreviated new drug
applications (ANDAs) that reference the listed drug CONCERTA
(methylphenidate hydrochloride (HCl)) extended-release tablets (new
drug application (NDA) 021121). The draft guidance is a revised version
of a previously issued draft guidance on the same subject.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comments on
this draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by January 5, 2015.

ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information, Center for Drug
Evaluation and Research, Food and Drug Administration, 10001 New
Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD
20993-0002. Send one self-addressed adhesive label to assist that
office in processing your requests. See the SUPPLEMENTARY INFORMATION
section for electronic access to the draft guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Kris Andr[eacute], Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 4726, Silver Spring, MD 20993-0002, 240-
402-7959.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of June 11, 2010 (75 FR 33311), FDA
announced the availability of a guidance for industry, ``Bioequivalence
Recommendations for Specific Products,'' which explained the process
that would be used to make product-specific BE recommendations
available to the public on FDA's Web site at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm. As
described in that guidance, FDA adopted this process as a means to
develop and disseminate product-specific BE recommendations and provide
a meaningful opportunity for the public to consider and comment on
those recommendations. This notice announces the availability of draft
BE recommendations for CONCERTA (methylphenidate HCl) extended-release
tablets. This draft guidance revises and replaces the draft guidance
for industry entitled ``Draft and Revised Draft Guidances for Industry
Describing Product-Specific Bioequivalence Recommendations;
Availability,'' issued on September 14, 2012 (77 FR 56851), which
provided recommendations to establish BE to CONCERTA (methylphenidate
hydrochloride) (NDA 021121).
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the Agency's current thinking on the design
of BE studies to support ANDAs for CONCERTA (methylphenidate HCl)
extended-release tablets. It does not create or confer any rights for
or on any person and does not operate to bind FDA or the public. An
alternative approach may be used if such approach satisfies the
requirements of the applicable statutes and regulations.

II. Comments

    Interested persons may submit either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

III. Electronic Access

    Persons with access to the Internet may obtain the document at
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: October 31, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-26306 Filed 11-5-14; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 77, Number 119 (Wednesday, June 20, 2012)]
[Notices]
[Page 37037]
[FR Doc No: 2012-15039]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 11175-024]

Crown Hydro LLC; Notice of Initiation of Proceeding To Terminate
License By Implied Surrender and Soliciting Comments and Motions To
Intervene

    Take notice that the following hydroelectric proceeding has been
initiated by the Commission:
    a. Types of Proceeding: Termination of License by Implied
Surrender.
    b. Project No.: 11175-024.
    c. Date Initiated: June 14, 2012.
    d. Licensee: Crown Hydro, LLC.
    e. Name and Location of Project: The 3.4-Megawatt (MW) Crown Mill
Hydroelectric Project is located at the Upper St Anthony Falls Dam on
the Mississippi River in the City of Minneapolis, Hennepin County,
Minnesota.
    f. Proceeding Initiated Pursuant to: Standard Article 35 of the
Project's license.
    g. FERC Contact: Mrs. Anumzziatta Purchiaroni,<PHONE_NUMBER>,
<EMAIL_ADDRESS>    h. Deadline for filing comments, protest, and motions to intervene:
July 19, 2012.
    Comments, Motions to Intervene, and Protests may be filed
electronically via the Internet. See, 18 CFR 385.2001(a)(1)(iii) and
the instructions on the Commission's Web site under the ``eFiling''
link. Include the project number (P-11175-024) on any documents or
motions filed. To paper-file, an original and eight copies should be
mailed to: Secretary, Federal Energy Regulatory Commission, 888 First
Street NE., Washington, DC 20426. For more information on how to submit
these types of filings, please go to the Commission's Web site located
at http://www.ferc.gov/filing-comments.asp.
    The Commission's Rules of Practice and Procedure require all
intervenors filing documents with the Commission to serve a copy of
that document on each person in the official service list for the
project. Further, if an intervenor files comments or documents with the
Commission relating to the merits of an issue that may affect the
responsibilities of a particular resource agency, they must also serve
a copy of the document on that resource agency.
    i. Description of Existing Facilities: The licensee has performed
no on-site construction or ground-disturbing activities.\1\
---------------------------------------------------------------------------

    \1\ The licensee met the March 2003 deadline to commence project
construction by initiating turbine manufacture. See June 19, 2003
letter from Commission staff.
---------------------------------------------------------------------------

    j. Description of Proceeding: The Commission has initiated this
Termination of License by Implied Surrender proceeding for the Crown
Mill Hydroelectric Project No. 11175 because over 13 years have passed
since the issuance of the license, the licensee has failed to complete
construction of the project as licensed, and its filings fail to show
it can do so in the near future.
    In 1999 the Commission issued a major license for the 3.4-megawatt
(MW) Crown Mill Hydroelectric Project. The authorized project includes:
A reconstructed upper canal and intake tunnel; a powerhouse located at
the basement of the Crown Roller Mill Building and containing two
hydropower units with a total capacity of 3.4 MW; an existing tailrace
tunnel and a reconstructed tailrace canal; and an underground
transmission line.
    Standard Article 35 of the license for Project No. 11175 provides,
in pertinent part:

    If the licensee shall cause or suffer essential project property
to be removed or destroyed or to become unfit for use, without
adequate replacement, or shall abandon or discontinue good faith
operation of the project or refuse or neglect to comply with the
terms of the license and the lawful orders of the Commission mailed
to the record address of the Licensee or its agent, the Commission
will deem it to be the intent of the Licensee to surrender the
license.\2\
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    \2\ Crown Hydro Co., 86 FERC ] 62, 209, at 64,289, incorporating
by reference form L-6 (Revised Oct. 1975), entitled ``Terms and
Conditions of License for Unconstructed Major Project Affecting
Navigable Waters and Lands of the United States,'' 54 F.P.C. 1792
(1975).

    In 2002, the licensee filed an application to amend the license to
relocate the powerhouse to the east side of the West River Parkway in
the footprint of the remains of the Holly and Cataract Mill Foundation
owned by the Minneapolis Park and Recreation Board (Park Board) because
it stated it could not secure a lease agreement with the owner of the
Crown Roller Building and, therefore, it could not construct the
project as licensed. In 2005, the Commission dismissed the licensee's
amendment application on the grounds that the licensee could not show
that it could obtain the necessary property rights from the Park
Board.\3\
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    \3\ See Crown Hydro LLC, 110 FERC ] 62,121 (2005), order denying
reh'g and request for abeyance, 111 FERC ] 61,315 (2005).
---------------------------------------------------------------------------

    On May 25, 2011, Commission staff sent the licensee a letter
stating that the staff considered the project to have been abandoned
and that it was the licensee's intent to surrender the license and
asking the licensee to show cause why the Commission, based upon these
conclusions, should not terminate the license. The licensee responded
on June 23, 2011, stating its intent to file yet another amendment
application to develop a substantially different project that would be
located in the headrace canal adjacent to the U.S. Army Corps of
Engineers (USACE) Lock and Dam and on USACE lands. This response and
subsequent filings of the licensee indicates that it is in the very
early stages of preparing a license amendment application that will
materially alter the project facilities and their locations from those
as originally licensed. After more than 13 years since the issuance of
the license, there is still no expectation that the licensee will
complete construction of the project in the foreseeable future.
    k. Individuals desiring to be included on the Commission's mailing
list for this proceeding should so indicate by writing to the Secretary
of the Commission.
    l. Filing and Service of Responsive Documents: Any filing must bear
in all capital letters the title ``COMMENTS'', ``PROTEST'', or ``MOTION
TO INTERVENE'', as applicable, and the Project Number of the proceeding
(P-11175-024).
    m. Agency Comments--Federal, states, and local agencies are invited
to file comments on the described proceeding. If an agency does not
file comments within the time specified for filing comments, it will be
presumed to have no comments.

    Dated: June 14, 2012.
Kimberly D. Bose,
Secretary.
[FR Doc. 2012-15039 Filed 6-19-12; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 86, Number 25 (Tuesday, February 9, 2021)]
[Rules and Regulations]
[Pages 8700-8704]
[FR Doc No: 2021-02512]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2020-0568; FRL-10017-55]

Extension of Tolerances for Emergency Exemptions; Multiple
Chemicals

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation extends time-limited tolerances for residues
of the pesticides clothianidin, methyl bromide, and triclopyr in or on
various commodities, as identified in this document. These actions are
in response to EPA's granting of emergency exemptions under the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA) authorizing use of
these pesticides. In addition, the Federal Food, Drug, and Cosmetic Act
(FFDCA) requires EPA to establish a time-limited tolerance or exemption
from the requirement for a tolerance for pesticide chemical residues in
food that will result from the use of a pesticide under an emergency
exemption granted by EPA. Additionally, EPA is removing time-limited
tolerances for flonicamid on prickly pear, fruit and pads at 1.5 ppm
because this exemption will not be renewed, and the tolerances will
expire by the effective date of this rule. EPA is also making non-
substantive administrative revisions to the tolerance listings for
methyl bromide to update the commodity terminology.

DATES: This regulation is effective February 9, 2021. Objections and
requests for hearings must be received on or before April 12, 2021 and
must be filed in accordance with the instructions

provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY
INFORMATION).

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2020-0568, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334,
1301 Constitution Ave. NW, Washington, DC 20460-0001. The Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is<PHONE_NUMBER>, and the telephone number for the OPP
Docket is<PHONE_NUMBER>.
    Due to the public health concerns related to COVID-19, the EPA
Docket Center (EPA/DC) and Reading Room is closed to visitors with
limited exceptions. The staff continues to provide remote customer
service via email, phone, and webform. For the latest status
information on EPA/DC services and docket access, visit https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Marietta Echeverria, Registration
Division (7505P), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001; main telephone number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of 40 CFR
part 180 through the Government Publishing Office's e-CFR site at
http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2020-0568 in the subject line on the first
page of your submission. All objections and requests must be in writing
and must be received by the Hearing Clerk on or before April 12, 2021.
Addresses for mail and hand delivery of objections and hearing requests
are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2020-0568, by one of
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at https://www.epa.gov/dockets/where-send-comments-epa-dockets. Additional instructions on commenting or visiting the docket,
along with more information about dockets generally, is available at
http://www.epa.gov/dockets.

II. Background and Statutory Findings

    EPA previously published final rules establishing time-limited
tolerances in the Federal Register for the chemicals and commodities
listed, below, under FFDCA section 408, 21 U.S.C. 346a. EPA established
the tolerances because FFDCA section 408(l)(6) requires EPA to
establish a time-limited tolerance or exemption from the requirement
for a tolerance for pesticide chemical residues in food that will
result from the use of a pesticide under an emergency exemption granted
by EPA under FIFRA section 18. Such tolerances can be established at
EPA's own initiative and without providing notice or time for public
comment.
    EPA received requests to extend emergency uses of clothianidin,
methyl bromide, and triclopyr for this year's growing season. After
having reviewed these submissions, EPA concurs that emergency
conditions continue to exist. EPA assessed the potential risks
presented by residues for each chemical in the pertinent commodities.
In doing so, EPA considered the safety standard in FFDCA section
408(b)(2) and decided that the necessary tolerance under FFDCA section
408(l)(6) would be consistent with the safety standard and with FIFRA
section 18.
    The data and other relevant material have been evaluated and were
discussed in the final rules originally establishing the time-limited
tolerances. Based on those data and information considered, the Agency
reaffirms that extension of these time-limited tolerances will continue
to meet the requirements of FFDCA section 408(l)(6). Therefore, the
time-limited tolerances are extended until December 31, 2023. Although
these tolerances will expire and are revoked on December 31, 2023,
under FFDCA section 408(l)(5), residues of the pesticide not in excess
of the amounts specified in the tolerances remaining in or on the
commodities after that date will not be unlawful, provided the residue
is present as a result of an application or use of a pesticide at a
time and in a manner that was lawful under FIFRA, the tolerance was in
place at the time of the application, and the residue does not exceed
the level that was authorized by the tolerance. EPA will take action to
revoke these tolerances earlier if any experience with, scientific data
on, or other relevant information on this pesticide indicate that the
residues are not safe. EPA will publish a document in the Federal
Register to remove the revoked tolerances from the Code of Federal
Regulations (CFR).
    Time-limited tolerances for the use of the following pesticide
chemicals on specific commodities are being extended:
    Clothianidin. EPA has authorized under FIFRA section 18 the use of
clothianidin on citrus for control of the Asian citrus psyllid in
Florida and Texas. This regulation extends a time-limited tolerance for
residues of the insecticide clothianidin and its

metabolites and degradates in or on fruit, citrus, group 10-10 at 0.07
parts per million (ppm) for an additional 3-year period. This tolerance
will expire and is revoked on December 31, 2023. The time-limited
tolerance was originally published in the Federal Register of February
25, 2015 (80 FR 10003) (FRL-9919-59).
    Methyl bromide. Pursuant to a request by the US Department of
Agriculture, Animal and Plant Health Inspection Service, EPA has
authorized under FIFRA section 18 the use of methyl bromide on certain
imported and domestic commodities, post-harvest for control of invasive
non-indigenous quarantine plant pests and to prevent the introduction
and/or spread of any new or recently introduced foreign pests to the
United States. This regulation extends time-limited tolerances for
residues of the pesticide methyl bromide, including its metabolites and
degradates, in or on the commodities identified in 40 CFR 180.124(b)
(and listed in the regulatory text section of this document) at the
levels listed for an additional 3-year period. The tolerances will
expire and are revoked on December 31, 2023. The time-limited
tolerances were originally published in the Federal Register of March
1, 2018 (83 FR 8758) (FRL-9971-19) and October 16, 2020 (85 FR 65729)
(FRL-10014-31).
    In addition to extending these tolerances, EPA is making several
non-substantive revisions to 40 CFR 180.124(b). Entries for avocado,
banana, longan, lychee, pomegranate, rambutan, and Spanish lime are
deleted, because these commodities are included in Tropical and
subtropical fruits, inedible peel, group 24. This regulation also
revises certain commodity terms for consistency with current crop
groups and commodity vocabulary as follows: ``Tropical and subtropical
fruits, edible peel, group 23'' will now read ``Fruit, tropical and
subtropical, edible peel, group 23''; ``Tropical and subtropical
fruits, inedible peel, group 24'' will now read ``Fruit, tropical and
subtropical, inedible peel, group 24''; and ``Stalk, stem and leaf
petiole vegetables, group 22'' will now read ``Vegetables, stalk, stem
and leaf petiole, group 22''. None of the revisions discussed in this
paragraph change the amount of methyl bromide residues permitted on any
commodity.
    Triclopyr. EPA has authorized under FIFRA section 18 the use of
triclopyr on sugarcane for control of divine nightshade (Solanum
nigresens) in Louisiana. This regulation extends a time-limited
tolerance for residues of the herbicide triclopyr and its metabolites
and degradates in or on sugarcane, cane at 40 ppm for an additional 3-
year period. The tolerance will expire and is revoked on December 31,
2023. A time-limited tolerance was originally published in the Federal
Register of June 8, 2017 (82 FR 26599) (FRL-9961-29).
    The time-limited tolerances are being removed at 40 CFR 180.613(b)
for residues of the insecticide flonicamid and its metabolites in or on
prickly pear, fruit and pads at 1.5 ppm which expire on December 31,
2020. The applicant has not submitted a request for further use of
flonicamid on prickly pear. The time-limited tolerances were originally
published in the Federal Register of January 26, 2018 (83 FR 3610)
(FRL-9971-94).

III. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level. The Codex has not
established any MRLs for flonicamid, methyl bromide, or triclopyr on
the commodities listed in this document. The Codex has established MRLs
for clothianidin in or on citrus at 0.07 ppm, the same as the tolerance
established for fruit, citrus, group 10-10 in the United States.
Therefore, there are no harmonization issues.

IV. Statutory and Executive Order Reviews

    This action establishes tolerances under FFDCA section 408(e) and
408(l)(6). The Office of Management and Budget (OMB) has exempted these
types of actions from review under Executive Order 12866, entitled
``Regulatory Planning and Review'' (58 FR 51735, October 4, 1993).
Because this action has been exempted from review under Executive Order
12866, this action is not subject to Executive Order 13211, entitled
``Actions Concerning Regulations That Significantly Affect Energy
Supply, Distribution, or Use'' (66 FR 28355, May 22, 2001) or Executive
Order 13045, entitled ``Protection of Children from Environmental
Health Risks and Safety Risks'' (62 FR 19885, April 23, 1997). This
action does not contain any information collections subject to OMB
approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et
seq.), nor does it require any special considerations under Executive
Order 12898, entitled ``Federal Actions to Address Environmental
Justice in Minority Populations and Low-Income Populations'' (59 FR
7629, February 16, 1994).
    Since tolerances and exemptions that are established under FFDCA
sections 408(e) and 408(l)(6), such as the tolerance in this final
rule, do not require the issuance of a proposed rule, the requirements
of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.), do not
apply.
    This action directly regulates growers, food processors, food
handlers, and food retailers, not States or Tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
Tribal Governments, on the relationship between the National Government
and the States or Tribal Governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian Tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this action. In addition, this
action does not impose any enforceable duty or contain any unfunded
mandate as described under Title II of the Unfunded Mandates Reform Act
(UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act (NTTAA) (15 U.S.C. 272 note).

V. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA has submitted a report containing this rule

and other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. This action is not
a ``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

    Dated: December 4, 2020.
Marietta Echeverria,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, for the reasons stated in the preamble, EPA is amending
40 CFR chapter I as follows:

PART 180--TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES
IN FOOD

0
1. The authority citation for part 180 continues to read as follows:

    Authority:  21 U.S.C. 321(q), 346a and 371.

0
2. In Sec.  180.124, revise paragraph (b) to read as follows:

Sec.  180.124  Methyl bromide; tolerances for residues.

* * * * *
    (b) Section 18 emergency exemptions. Time-limited tolerances are
established for residues of the fumigant methyl bromide, including its
metabolites and degradates, in or on the specified agricultural
commodities in Table 2 to this paragraph (b). Compliance with the
tolerance levels specified in Table 2 to this paragraph (b) is to be
determined by measuring only methyl bromide, in or on the commodities,
resulting from use of the pesticide pursuant to Federal Insecticide,
Fungicide, Rodenticide Act (FIFRA) section 18 emergency exemptions. The
tolerances expire and are revoked on the dates specified in Table 2 to
this paragraph (b).

                        Table 2 to Paragraph (b)
------------------------------------------------------------------------
                                                            Expiration/
                Commodity                    Parts per      revocation
                                              million          date
------------------------------------------------------------------------
Berry and small fruit, group 13-07......             5.0        12/31/23
Cactus..................................             3.0        12/31/23
Coconut, copra..........................             8.0        12/31/23
Coffee, green bean......................             150        12/31/23
Cola, seed..............................             150        12/31/23
Cucurbit, seed..........................             150        12/31/23
Fig.....................................              10        12/31/23
Fruit, citrus, group 10-10..............               2        12/31/23
Fruit, stone, group 12-12...............             5.0        12/31/23
Fruit, tropical and subtropical, edible               10        12/31/23
 peel, group 23.........................
Fruit, tropical and subtropical,                     5.0        12/31/23
 inedible peel, group 24................
Herb and spice, group 19................              35        12/31/23
Hibiscus, seed..........................             150        12/31/23
Ivy gourd...............................             5.0        12/31/23
Kaffir lime, leaves.....................            0.50        12/31/23
Kenaf, seed.............................             150        12/31/23
Oilseed group 20........................             150        12/31/23
Peppermint, tops........................              35        12/31/23
Pointed gourd...........................             5.0        12/31/23
Spearmint, tops.........................              35        12/31/23
Vegetable, bulb, group 3-07.............             2.0        12/31/23
Vegetable, cucurbit, group 9............             5.0        12/31/23
Vegetable, foliage of legume, group 7...            0.50        12/31/23
Vegetable, fruiting, group 8-10.........             7.0        12/31/23
Vegetable, head and stem Brassica, group             1.0        12/31/23
 5-16...................................
Vegetable, leafy, group 4-16............            0.50        12/31/23
Vegetable, leaves of root and tuber,                0.50        12/31/23
 group 2................................
Vegetable, legume, group 6..............             3.0        12/31/23
Vegetable, root and tuber, group 1......             3.0        12/31/23
Vegetable, stalk, stem and leaf petiole,            0.50        12/31/23
 group 22...............................
------------------------------------------------------------------------

* * * * *

0
3. In Sec.  180.417, revise the table in paragraph (b) to read as
follows:

Sec.  180.417  Triclopyr; tolerances for residues.

* * * * *
    (b) * * *

                        Table 3 to Paragraph (b)
------------------------------------------------------------------------
                                                            Expiration/
                Commodity                    Parts per      revocation
                                              million          date
------------------------------------------------------------------------
Sugarcane, cane.........................              40        12/31/23
------------------------------------------------------------------------

* * * * *

0
4. In Sec.  180.586, revise the entry for ``Fruit, citrus, group 10-
10'' in the table in paragraph (b) to read as follows:

Sec.  180.586  Clothianidin; tolerances for residues.

* * * * *
    (b) * * *

------------------------------------------------------------------------
                                                            Expiration/
                Commodity                    Parts per      revocation
                                              million          date
------------------------------------------------------------------------
Fruit, citrus, group 10-10..............            0.07        12/31/23

                              * * * * * * *
------------------------------------------------------------------------

* * * * *

Sec.  180.613  [Amended]

0
5. In Sec.  180.613, remove and reserve paragraph (b).

[FR Doc. 2021-02512 Filed 2-8-21; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 76, Number 77 (Thursday, April 21, 2011)]
[Notices]
[Page 22393]
[FR Doc No: 2011-9658]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[P-13123-002-CA]

Eagle Mountain Pumped Storage Hydroelectric Project, Eagle Crest
Energy; Notice of Cancellation of Teleconference

    On March 15, 2011, the Commission issued public notice of a
teleconference scheduled to occur on Friday, April 15, 2011 at 9 a.m.
(Pacific Time). The teleconference was scheduled as part of our on-
going Section 7 Endangered Species Act consultation efforts with the
U.S. Fish and Wildlife Service for the proposed Eagle Mountain Pumped
Storage Hydroelectric Project. This meeting has been cancelled.
    We will reschedule this meeting in the near future and provide
public notice.

    Dated: April 13, 2011.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2011-9658 Filed 4-20-11; 8:45 am]
BILLING CODE 6717-01-P


FILE NAME:   company.wpt   (7/1/2005) (xml)

Template Number P25

COMPANY FEDERAL REGISTER DOCUMENT SUBMISSION TEMPLATE

(1/1/2005)

EPA Registration Division contact: [Bipin Gandhi,<PHONE_NUMBER>]

TEMPLATE:

960 to establish an exemption from the requirement of a tolerance for

[2-propenoic, 2-methyl-, polymers with ethyl acrylate and polyethylene glycol methylacrylate C18-22 alkyl ethers (No CASRN; EPA Accession No. 251695)] in or on the raw agricultural commodity [seeds]. EPA has determined that the petition contains data or information regarding the elements set forth in section 408(d)(2) of the FFDCA; however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data supports granting of the petition.  Additional data may be needed before EPA rules on the petition.

	a. Analytical chemistry: Lubrizol is petitioning that 2-propenoic, 2-methyl-, polymers with ethyl acrylate and polyethylene glycol methylacrylate C18-22 alkyl ethers (No CASRN; EPA Accession No. 251695) be exempt from the requirement of a tolerance based on the definition of a low risk polymer under 40 CFR 723.250(e). Therefore, the analytical method to determine residues of 2-propenoic, 2-methyl-, polymers with ethyl acrylate and polyethylene glycol methylacrylate C18-22 alkyl ethers in raw agricultural commodities is not required.

	b. The polymeric substance is an acrylic copolymer latex, the product of the polymerization of methacrylic acid, ethyl acrylate and PEG behenyl ether methacrylate. The polymer is supplied as an aqueous dispersion of approximately 30 wt% latex solids in water containing sodium lauryl sulfate (0.4 wt%) as a surface-active agent.

.  [ As part of the EPA policy statement on inert ingredients published in the Federal Register of April 22, 1987 (52 FR 13305), the Agency set forth a list of studies that would generally be used to evaluate the risks posed by the presence of an inert ingredient in a pesticide formulation. However, where it can be determined without the data that the inert ingredient will present minimal or no risk, the Agency generally does not require some or all of the listed studies to rule on the proposed tolerance, or exemption from the requirement of a tolerance, for an inert ingredient. The established set of criteria for polymers of low concern is described in 40 CFR 723.250 for polymers that are relatively unreactive and stable compared to other chemical substances. These properties generally limit the ability of a polymer to cause adverse effects.  Lubrizol believes that the data and information described below is adequate to ascertain the toxicology and characterize the risk associated with the use of  the polymer 2-propenoic, 2-methyl-, polymers with ethyl acrylate and polyethylene glycol methylacrylate C18-22 alkyl ethers as an inert ingredient in pesticide formulations applied to raw agricultural commodities (seeds).

2-propenoic, 2-methyl-, polymers with ethyl acrylate and polyethylene glycol methylacrylate C18-22 alkyl ethers has been notified to the TSCA Inventory and is listed as polymer exempt (XU) (EPA PMN No. P-03-216; Accession No. 251695).

2-propenoic, 2-methyl-, polymers with ethyl acrylate and polyethylene glycol methylacrylate C18-22 alkyl ethers is not cationic.

2-propenoic, 2-methyl-, polymers with ethyl acrylate and polyethylene glycol methylacrylate C18-22 alkyl ethers contains as an integral part of its composition the atomic elements carbon, oxygen and hydrogen.

2-propenoic, 2-methyl-, polymers with ethyl acrylate and polyethylene glycol methylacrylate C18-22 alkyl ethers does not contain as an integral part of its composition, except as impurities, any elements other than those listed in 40 CFR 723.250 (d) (2) (ii).

2-propenoic, 2-methyl-, polymers with ethyl acrylate and polyethylene glycol methylacrylate C18-22 alkyl ethers is not designed, nor is it reasonably anticipated, to substantially degrade, decompose or depolymerize.

2-propenoic, 2-methyl-, polymers with ethyl acrylate and polyethylene glycol methylacrylate C18-22 alkyl ethers is not manufactured or imported from monomers and/or other reactants that are not already on the TSCA chemical substance inventory

2-propenoic, 2-methyl-, polymers with ethyl acrylate and polyethylene glycol methylacrylate C18-22 alkyl ethers is a water absorbing polymer. However, this property was not considered a concern by the Agency.

The acrylic copolymer is a rheology modifier for use in aqueous compositions. The polymer is manufactured using a water soluble initiator in the emulsion polymerization reaction that yields an aqueous latex dispersion at an approximate 30 wt% solids content. The polymer is manufactured and only intended for commerce as an aqueous latex dispersion. The manufactured polymer can not readily be rendered, or used, in the form of a solid. Therefore, water swelling is not a concern for the Agency.

2-propenoic, 2-methyl-, polymers with ethyl acrylate and polyethylene glycol methylacrylate C18-22 alkyl ethers does not contain reactive functional groups.

The polymer 2-propenoic, 2-methyl-, polymers with ethyl acrylate and polyethylene glycol methylacrylate C18-22 alkyl ethers has a number-average molecular weight of 94,600 Daltons (molecular weight distribution 8,100 – 6,421,000 Daltons). Substances with molecular weight greater than 400 generally are not absorbed through the intact skin, and substances with molecular weights greater than 1000 generally are not absorbed through the intact gastrointestinal tract. Chemicals not absorbed through the skin or GI tract generally are incapable of eliciting a toxic response.

2-propenoic, 2-methyl-, polymers with ethyl acrylate and polyethylene glycol methylacrylate C18-22 alkyl esters contains < 0.01 wt% oligomeric material below molecular weight 500, and < 0.01 wt% oligomeric material below 1000 molecular weight.

While not expected to be elicit systemic toxicity, the acrylic copolymer 2-propenoic, 2-methyl-, polymers with ethyl acrylate and polyethylene glycol methylacrylate C18-22 alkyl ethers is known to be a mild dermal and ocular irritant. Studies in rabbits resulted in a dermal Primary Irritant Index score = 0.5 (mild irritant) and a maximum mean ocular irritation score = 10.0 (scale 0 – 110; mild irritant). The irritation study reports are submitted as a separate attachment to this submission. This polymer would not contribute significantly to the irritation potential of the end-use formulation.

It should be noted that many similar acrylic copolymers have been found to be polymers of low concern and ruled to be low risk polymers by the Agency.

Sodium lauryl sulfate (CASRN 151-21-3) is present in the commercial mixture as a surface-active agent to a concentration of 0.4 wt%. The surfactant (sodium lauryl sulfate) does not become an intrinsic part of the polymer, rather it is absorbed onto the surface of the polymer particles.

Sodium lauryl sulfate (CASRN 151-21-3) is listed as a food additive permitted for direct addition to food for human consumption (21 CFR 172.822) and as a surface-active agent that may be safely used in the manufacture of articles, or components of articles intended for use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting or holding food (21 CFR 178.3400).

.  [The Agency has maintained that polymers meeting the polymer exemption criteria will present minimal risk to human health when used as inert ingredients in pesticide formulations applied to food crops. EPA has also established exemptions from tolerance for polymeric materials used as pesticide inerts that it considers to be intrinsically safe based on the fact that they are listed on the TSCA Inventory or meet the requirements of the amended TSCA polymer exemption. Exposure to the final use dilution of 2-propenoic, 2-methyl-, polymers with ethyl acrylate and polyethylene glycol methylacrylate C18-22 alkyl ethers  when used as an inert ingredient in pesticide formulations is believed to be inconsequential.

 PAGE  5

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[Federal Register Volume 80, Number 90 (Monday, May 11, 2015)]
[Notices]
[Pages 26929-26930]
[FR Doc No: 2015-11257]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-0001]

Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

    This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will
be open to the public.
    Name of Committee: Pulmonary-Allergy Drugs Advisory Committee.
    General Function of the Committee: To provide advice and
recommendations to the Agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on June 11, 2015, from 8
a.m. to 5 p.m.
    Location: Hilton Washington DC North/Gaithersburg, Grand Ballroom,
620 Perry Pkwy., Gaithersburg, MD 20877. Answers to commonly asked
questions including information regarding special accommodations due to
a disability, visitor parking, and transportation may be accessed at:
http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.
    Contact Person: Kristina Toliver, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
31, Rm. 2417, Silver Spring, MD 20993-0002,<PHONE_NUMBER>, FAX: 301-847-
8533, email<EMAIL_ADDRESS>or FDA Advisory Committee Information
Line, 1-800-741-8138<PHONE_NUMBER> in the Washington, DC area). A
notice in the Federal Register about last minute modifications that
impact a previously announced advisory committee meeting cannot always
be published quickly enough to provide timely notice. Therefore, you
should always check the Agency's Web site at http://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate
advisory committee meeting link, or call the advisory committee
information line to learn about possible modifications before coming to
the meeting.
    Agenda: The committee will discuss biologics license application
(BLA) 125526, for mepolizumab for injection, submitted by
GlaxoSmithKline for the proposed indication of add-on maintenance
treatment in patients 12 years and older with severe eosinophilic
asthma identified by blood eosinophils greater than or equal to 150
cells/microliter at initiation of treatment or blood eosinophils
greater than or equal to 300 cells/microliter in the past 12 months.
    FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its Web site prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's Web site after the meeting. Background material is
available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting
link.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person on or before May
28, 2015. Oral presentations from the public will be scheduled between
approximately 1 p.m. and 2 p.m. Those individuals interested in making
formal oral presentations should notify the contact person and submit a
brief statement of the general nature of the evidence or arguments they
wish to present, the names and addresses of proposed participants, and
an indication of the approximate time requested to make their
presentation on or before May 19, 2015. Time allotted for each
presentation may be limited. If the number of registrants requesting to
speak is greater than can be reasonably accommodated during the
scheduled open public hearing session, FDA may

conduct a lottery to determine the speakers for the scheduled open
public hearing session. The contact person will notify interested
persons regarding their request to speak by May 20, 2015.
    Persons attending FDA's advisory committee meetings are advised
that the Agency is not responsible for providing access to electrical
outlets.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
physical disabilities or special needs. If you require special
accommodations due to a disability, please contact Kristina Toliver at
least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: May 5, 2015.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2015-11257 Filed 5-8-15; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 84, Number 224 (Wednesday, November 20, 2019)]
[Notices]
[Pages 64058-64059]
[FR Doc No: 2019-25142]

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

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 Number: PR20-8-000.
    Applicants: Columbia Gas of Ohio, Inc.
    Description: Tariff filing per 284.123(b),(e)/: Revised SOC to be
effective 10/29/2019.
    Filed Date: 11/12/19.
    Accession Number:<PHONE_NUMBER>59.
    Comments/Protests Due: 5 p.m. ET 12/3/19.

    Docket Number: PR20-9-000.
    Applicants: Southcross Nueces Pipelines LLC.
    Description: Tariff filing per 284.123(e)+(g): Cancellation of SOC
to be effective 11/12/2019.
    Filed Date: 11/12/19.
    Accession Number:<PHONE_NUMBER>12.
    Comments Due: 5 p.m. ET 12/3/19.
    284.123(g) Protests Due: 5 p.m. ET 1/13/20.

    Docket Numbers: RP19-1641-001.
    Applicants: Panhandle Eastern Pipe Line Company, LP.
    Description: Compliance filing Compliance with RP19-1641 Fuel
Filing Order to be effective 11/1/2019.
    Filed Date: 11/8/19.
    Accession Number: 20191108-5031.
    Comments Due: 5 p.m. ET 11/20/19.

    Docket Numbers: RP20-217-000.
    Applicants: KPC Pipeline, LLC.
    Description: Sec.  4(d) Rate Filing: Tariff Filing to Clarify
Ability to Negotiate Contractual ROFRs to be effective 12/9/2019.
    Filed Date: 11/8/19.
    Accession Number: 20191108-5030.
    Comments Due: 5 p.m. ET 11/20/19.

    Docket Numbers: RP20-218-000.
    Applicants: Iroquois Gas Transmission System, L.P.
    Description: Sec.  4(d) Rate Filing: 110819 Negotiated Rates--Emera
Energy Services, Inc. R-2715-39 to be effective 12/1/2019.
    Filed Date: 11/8/19.
    Accession Number: 20191108-5034.
    Comments Due: 5 p.m. ET 11/20/19.

    Docket Numbers: RP20-219-000.
    Applicants: Iroquois Gas Transmission System, L.P.
    Description: Sec.  4(d) Rate Filing: 110819 Negotiated Rates--Emera
Energy Services, Inc. R-2715-40 to be effective 12/1/2019.
    Filed Date: 11/8/19.
    Accession Number: 20191108-5035.
    Comments Due: 5 p.m. ET 11/20/19.

    Docket Numbers: RP20-220-000.
    Applicants: Columbia Gas Transmission, LLC.
    Description: Sec.  4(d) Rate Filing: TCO Arsenal Agreement
Termination to be effective 11/8/2019.
    Filed Date: 11/8/19.
    Accession Number: 20191108-5045.
    Comments Due: 5 p.m. ET 11/20/19.

    Docket Numbers: RP20-221-000.
    Applicants: Algonquin Gas Transmission, LLC.
    Description: Sec.  4(d) Rate Filing: Negotiated Rates--PSEG ERT
K800576 to be effective 11/8/2019.
    Filed Date: 11/8/19.
    Accession Number: 20191108-5115.
    Comments Due: 5 p.m. ET 11/20/19.

    Docket Numbers: RP20-222-000.
    Applicants: Northern Natural Gas Company.
    Description: Sec.  4(d) Rate Filing: 20191108 Negotiated Rate
Filing to be effective 11/10/2019.
    Filed Date: 11/8/19.
    Accession Number: 20191108-5151.
    Comments Due: 5 p.m. ET 11/20/19.

    Docket Numbers: RP20-223-000.
    Applicants: Southern Star Central Gas Pipeline, Inc.
    Description: Compliance filing Annual Operational Flow Order Report
2019 to be effective N/A.

    Filed Date: 11/12/19.
    Accession Number: 20191112-5017.
    Comments Due: 5 p.m. ET 11/25/19.

    Docket Numbers: RP20-224-000.
    Applicants: Southern Natural Gas Company, L.L.C.
    Description: Compliance filing Annual Report on Operational
Transactions 2019 to be effective N/A.
    Filed Date: 11/12/19.
    Accession Number: 20191112-5130.
    Comments Due: 5 p.m. ET 11/25/19.

    Docket Numbers: RP20-225-000.
    Applicants: Rockies Express Pipeline LLC.
    Description: Sec.  4(d) Rate Filing: Neg Rate 2019-11-11 CP, BP and
EOG to be effective 11/12/2019.
    Filed Date: 11/12/19.
    Accession Number: 20191112-5234.
    Comments Due: 5 p.m. ET 11/25/19.

    Docket Numbers: RP20-226-000.
    Applicants: NEXUS Gas Transmission, LLC.
    Description: Sec.  4(d) Rate Filing: Negotiated Rates--NJR,
Equinor, Twin Eagle eff 10-13-19 to be effective 11/13/2019.
    Filed Date: 11/12/19.
    Accession Number: 20191112-5256.
    Comments Due: 5 p.m. ET 11/25/19.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    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 date(s). Protests may be considered,
but intervention is necessary to become a party to the proceeding.
    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: November 14, 2019.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2019-25142 Filed 11-19-19; 8:45 am]
 BILLING CODE 6717-01-P