[Federal Register Volume 84, Number 212 (Friday, November 1, 2019)]
[Notices]
[Page 58817]
[FR Doc No: 2019-23949]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Notice of Intent To Rule on a Request To Release Surplus Property
at the Daniel Field Airport, Augusta, Georgia

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice and request for comment.

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SUMMARY: Under the provisions of Title 49, U.S.C. Section 47151(d),
notice is being given that the Federal Aviation Administration (FAA) is
considering a request from the City of Augusta to waive the requirement
that 0.13 acres of surplus property located at the Daniel Field Airport
be used for aeronautical purposes. Currently, the ownership of the
property provides for the protection of FAR Part 77 surfaces and
compatible land use which would continue to be protected with deed
restrictions required in the transfer of land ownership.

DATES: Comments must be received on or before December 2, 2019.

ADDRESSES: Comments on this application may be mailed or delivered to
the FAA at the following address: Rob Rau, Federal Aviation
Administration, Atlanta Airports District Office, 1701 Columbia Ave.,
Ste. 220, College Park, GA 30337.
    In addition, one copy of any comments submitted to the FAA must be
mailed to: David Fields, Chairman, General Aviation Commission, City of
Augusta, 1775 Highland Avenue, Augusta, GA 30904.

FOR FURTHER INFORMATION CONTACT: Rob Rau, Federal Aviation
Administration, Atlanta Airports District Office, 1701 Columbia Ave.,
Ste. 220, College Park, GA 30337<EMAIL_ADDRESS>The request to
release property may be reviewed, by appointment, in person at this
same location.

SUPPLEMENTARY INFORMATION: The FAA is reviewing a request to release
0.13 acres of surplus property at the Daniel Field Airport (DNL) under
the provisions of 49 U.S.C. 47151(d). On October 11, 2019, the City of
Augusta (with concurrence from Georgia Department of Transportation)
requested the FAA release 0.13 acres of surplus property for a
permanent utility easement. The FAA has determined that the proposed
property release at the Daniel Field Airport, as submitted by the City
of Augusta, meets the procedural requirements of the FAA and release of
the property does not and will not impact future aviation needs at the
airport. The FAA may approve the request, in whole or in part, no
sooner than thirty days after the publication of this notice. In
accordance with 49 U.S.C. 47107(c)(2)(B)(i) and (iii), the airport will
receive fair market value for the easement, which will be subsequently
reinvested in another eligible airport improvement project for aviation
facilities at the Daniel Field Airport.
    Any person may inspect, by appointment, the request in person at
the FAA office listed above under FOR FURTHER INFORMATION CONTACT. In
addition, any person may, upon appointment and request, inspect the
application, notice and other documents determined by the FAA to be
related to the application in person at the Daniel Field Airport.

    Issued in Atlanta, GA, on October 23, 2019.
Larry F. Clark, Manager,
Atlanta Airports District Office.
[FR Doc. 2019-23949 Filed 10-31-19; 8:45 am]
BILLING CODE 4910-13-P


August 31, 2010

MEMORANDUM

TO: EPA Docket #EPA-HQ-OAR-2009-0211

FROM: Robert Anderson, Environmental Protection Specialist,
EPA/OAR/OTAQ/CISD

RE: Preliminary Data from Tier DOE Catalyst Durability Program (V4/CRC
E-87-2)

Attached is an Excel spreadsheet that contains preliminary data from the
DOE Catalyst Durability Test Program also referred to as the DOE V4
program or the CRC E-87-2 program.  These data are preliminary results
for the Tier 2 vehicle portion of the test program.

The enclosed spreadsheet contains all data submitted to EPA from DOE as
of August 31, 2010.  It should be noted that these data are preliminary
and therefore, subject to change based on ongoing QA/QC.  Please read
the “readme” tab of the attached spreadsheet for more information
concerning the data.

For more information, please contact Robert Anderson at either
HYPERLINK<EMAIL_ADDRESS><EMAIL_ADDRESS>or
(202) 343-9718.


[Federal Register: January 21, 2010 (Volume 75, Number 13)]
[Notices]
[Page 3471-3472]
[DOCID:fr21ja10-60]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-D-0470]

International Conference on Harmonisation; Guidance on M3(R2)
Nonclinical Safety Studies for the Conduct of Human Clinical Trials and
Marketing Authorization for Pharmaceuticals; 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 guidance entitled ``M3(R2) Nonclinical Safety Studies
for the Conduct of Human Clinical Trials and Marketing Authorization
for Pharmaceuticals.'' The guidance was prepared under the auspices of
the International Conference on Harmonisation of Technical Requirements
for Registration of Pharmaceuticals for Human Use (ICH). The guidance,
which is a revision of an existing guidance, discusses the types of
nonclinical studies, their scope and duration, and their relation to
the conduct of human clinical trials and marketing authorization for
pharmaceuticals. The guidance is intended to facilitate the timely
conduct of clinical trials and reduce the unnecessary use of animals
and other drug development resources.

DATES:  Submit written or electronic comments on agency guidance at any
time.

ADDRESSES:  Submit written requests for single copies of the guidance
to the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, rm. 2201, Silver Spring, MD 20993-0002, or the Office of
Communication, Outreach and Development (HFM-40), Center for Biologics
Evaluation and Research (CBER), Food and Drug Administration, 1401
Rockville Pike, Rockville, MD 20852-1448. The guidance may also be
obtained by mail by calling CBER at 1-800-835-4709 or<PHONE_NUMBER>.
Send two self-addressed adhesive labels to assist the office in
processing your requests.
    Submit electronic comments to http://www.regulations.gov. Submit
written comments on the guidance to the Division of Dockets Management
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. See the SUPPLEMENTARY INFORMATION section for
electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT:
    Regarding the guidance: Abigail Jacobs, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave,
Bldg. 22, rm. 6484, Silver Spring, MD 20993-0002,<PHONE_NUMBER>; or
Martin D. Green, Center for Biologics Evaluation and Research (HFM-
475), Food and Drug Administration, 1401 Rockville Pike, suite 200N,
Rockville, MD 20852-1448,<PHONE_NUMBER>.
    Regarding the ICH: Michelle Limoli, Office of International
Programs (HFG-1), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    In recent years, many important initiatives have been undertaken by
regulatory authorities and industry associations to promote
international harmonization of regulatory requirements. FDA has
participated in many meetings designed to enhance harmonization and is
committed to seeking scientifically based harmonized technical
procedures for pharmaceutical development. One of the goals of
harmonization is to identify and then reduce differences in technical
requirements for drug development among regulatory agencies.
    ICH was organized to provide an opportunity for tripartite
harmonization initiatives to be developed with input from both
regulatory and industry representatives. FDA also seeks input from
consumer representatives and others. ICH is concerned with
harmonization of technical requirements for the registration of
pharmaceutical products among three

regions: The European Union, Japan, and the United States. The six ICH
sponsors are the European Commission; the European Federation of
Pharmaceutical Industries Associations; the Japanese Ministry of
Health, Labour, and Welfare; the Japanese Pharmaceutical Manufacturers
Association; the Centers for Drug Evaluation and Research and Biologics
Evaluation and Research, FDA; and the Pharmaceutical Research and
Manufacturers of America. The ICH Secretariat, which coordinates the
preparation of documentation, is provided by the International
Federation of Pharmaceutical Manufacturers Associations (IFPMA).
    The ICH Steering Committee includes representatives from each of
the ICH sponsors and the IFPMA, as well as observers from the World
Health Organization, Health Canada, and the European Free Trade Area.
    In the Federal Register of September 3, 2008 (73 FR 51491), FDA
published a notice announcing the availability of a draft guidance
entitled ``M3(R2) Nonclinical Safety Studies for the Conduct of Human
Clinical Trials and Marketing Authorization for Pharmaceuticals.'' The
notice gave interested persons an opportunity to submit comments by
October 20, 2008.
    After consideration of the comments received and revisions to the
guidance, a final draft of the guidance was submitted to the ICH
Steering Committee and endorsed by the three participating regulatory
agencies in June 2009.
    Guidance is provided on the various nonclinical studies recommended
to support conduct of clinical trials and marketing. The guidance
further harmonizes the recommendations in a number of areas and
includes a new section on exploratory clinical trials. The
recommendations should promote safe and ethical development and
availability of new pharmaceuticals.
    The guidance reflects revisions made in response to comments
received on the draft guidance. The revisions include more detailed
discussions of some types of nonclinical studies and editorial changes
to provide further clarification in a number of areas.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
agency's current thinking on this topic. 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 to the Division of Dockets Management
(see ADDRESSES) electronic or written comments on the guidance. Submit
a single copy of electronic comments or two paper copies of any mailed
comments, except that individuals may submit one paper copy. Comments
are to be identified 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.

III. Electronic Access

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

    Dated: January 15, 2010.
David Dorsey,
Acting Deputy Commissioner for Policy, Planning and Budget.
[FR Doc. 2010-1027 Filed 1-20-10; 8:45 am]
BILLING CODE 4160-01-S


[Federal Register Volume 80, Number 143 (Monday, July 27, 2015)]
[Notices]
[Page 44406]
[FR Doc No: 2015-18323]

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SECURITIES AND EXCHANGE COMMISSION

Proposed Collection; Comment Request

Upon Written Request, Copies Available From: Securities and Exchange
Commission, Office of FOIA Services, 100 F Street NE., Washington, DC
20549-2736.

Extension:
    Rule 17f-1(c) and Form X-17F-1A; SEC File No. 270-29, OMB
Control No. 3235-0037

    Notice is hereby given that pursuant to the Paperwork Reduction Act
of 1995 (``PRA'') (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (``Commission'') is soliciting comments on the existing
collection of information provided for in Rule 17f-1(c) and Form X-17F-
1A (17 CFR 249.100) under the Securities Exchange Act of 1934 (15
U.S.C. 78a et seq.). The Commission plans to submit this existing
collection of information to the Office of Management and Budget
(``OMB'') for extension and approval.
    Rule 17f-1(c) requires approximately 15,500 entities in the
securities industry to report lost, stolen, missing, or counterfeit
securities certificates to the Commission or its designee, to a
registered transfer agent for the issue, and, when criminal activity is
suspected, to the Federal Bureau of Investigation. Such entities are
required to use Form X-17F-1A to make such reports. Filing these
reports fulfills a statutory requirement that reporting institutions
report and inquire about missing, lost, counterfeit, or stolen
securities. Since these reports are compiled in a central database, the
rule facilitates reporting institutions to access the database that
stores information for the Lost and Stolen Securities Program.
    We estimate that 15,500 reporting institutions will report that
securities are either missing, lost, counterfeit, or stolen annually
and that each reporting institution will submit this report 30 times
each year. The staff estimates that the average amount of time
necessary to comply with Rule 17f-1(c) and Form X-17F-1A is five
minutes. The total burden is approximately 38,750 hours annually for
respondents (15,500 times 30 times 5 divided by 60).
    Written comments are invited on: (a) Whether the proposed
collection of information is necessary for the proper performance of
the functions of the agency, including whether the information shall
have practical utility; (b) the accuracy of the agency's estimate of
the burden of the proposed collection of information; (c) ways to
enhance the quality, utility, and clarity of the information on
respondents; and (d) ways to minimize the burden of the collection of
information on respondents, including through the use of automated
collection techniques or other forms of information technology.
Consideration will be given to comments and suggestions submitted in
writing within 60 days of this publication.
    Rule 17f-1(c) is a reporting rule and does not specify a retention
period. The rule requires an incident-based reporting requirement by
the reporting institutions when securities certificates are discovered
to be missing, lost, counterfeit, or stolen. Registering under Rule
17f-1(c) is mandatory to obtain the benefit of a central database that
stores information about missing, lost, counterfeit, or stolen
securities for the Lost and Stolen Securities Program. Reporting
institutions required to register under Rule 17f-1(c) will not be kept
confidential; however, the Lost and Stolen Securities Program database
will be kept confidential.
    An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information under the PRA unless it
displays a currently valid OMB control number.
    Please direct your written comments to: Pamela Dyson, Director/
Chief Information Officer, Securities and Exchange Commission, c/o Remi
Pavlik-Simon, 100 F Street NE., Washington DC 20549, or send an email
to<EMAIL_ADDRESS>
    Dated: July 22, 2015.
Robert W. Errett,
Deputy Secretary.
[FR Doc. 2015-18323 Filed 7-24-15; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 83, Number 85 (Wednesday, May 2, 2018)]
[Notices]
[Pages 19376-19381]
[FR Doc No: 2018-09258]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-83113; File No. SR-NYSE-2018-15]

Self-Regulatory Organizations; New York Stock Exchange LLC;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change to
Adopt Transaction Fees In Connection with the Exchange's Trading of UTP
Securities on Pillar

April 26, 2018.
    Pursuant to Section 19(b)(1) \1\ of the Securities Exchange Act of
1934 (the

``Act'') \2\ and Rule 19b-4 thereunder,\3\ notice is hereby given that,
on April 17, 2018, New York Stock Exchange LLC (``NYSE'' or the
``Exchange'') filed with the Securities and Exchange Commission (the
``Commission'') the proposed rule change as described in Items I, II,
and III below, which Items have been prepared by the self-regulatory
organization. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
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    \1\ 15 U.S.C.78s(b)(1).
    \2\ 15 U.S.C. 78a.
    \3\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to adopt transaction fees in connection with
the Exchange's trading of UTP Securities on Pillar, the Exchange's new
trading technology platform. The Exchange proposes to implement these
changes to its Price List effective April 17, 2018.\4\ The proposed
rule change is available on the Exchange's website at www.nyse.com, at
the principal office of the Exchange, and at the Commission's Public
Reference Room.
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    \4\ The Exchange originally filed to amend the Price List on
April 9, 2018 (SR-NYSE-2018-13) and withdrew such filing on April
17, 2018.
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II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

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

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

1. Purpose
    On April 9, 2018, the Exchange will introduce trading of UTP
Securities on the Exchange on the Pillar trading platform.\5\ As
described in the UTP Trading Rules Filing, with Pillar, the Exchange
will continue to trade NYSE-listed securities on its current trading
platform without any changes.\6\
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    \5\ See Securities Exchange Act Release No.82945 (March 26,
2018), 83 FR 13553 (March 29, 2018) (SR-NYSE-2017-36) (the ``UTP
Trading Rules Filing''). The term ``UTP Security'' means a security
that is listed on a national securities exchange other than the
Exchange and that trades on the Exchange pursuant to unlisted
trading privileges. See Rule 1.1(ii).
    \6\ See UTP Trading Rules Filing, 83 FR at 13554, n.17.
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    In connection with the offering of trading in UTP Securities, the
Exchange proposes to amend its Price List to adopt a new pricing for
trading UTP Securities on the Pillar platform.
    The proposed changes would apply to transactions executed in
securities priced at or above and below $1.00.
    The Exchange proposes to implement these changes effective April
17, 2018.
Proposed Rule Change
    The Exchange proposes the following transaction fees for UTP
trading on its Pillar trading platform.
    The Exchange proposes to add the following heading immediately
after the crossing session fees and credits in the current fee
schedule: ``Transaction Fees and Credits For Securities Traded Pursuant
to Unlisted Trading Privileges (Tapes B and C) on the Pillar Trading
Platform.'' The Exchange believes that the proposed legend would
clarify which fees and credits in the current fee schedule would be
applicable to trading UTP Securities on the Pillar platform, and thus
add clarity and promote transparency.
    Immediately below this proposed heading, the Exchange proposes a
second heading titled ``Fees and Credits applicable to Market
Participants.''
General Information Applicable to the Price List
    The Exchange proposes to summarize general information applicable
to fees for trading UTP Securities on the Pillar trading platform in
two bullets under the second heading in the proposed Price List.
    The first bullet would provide that rebates are indicated by
parentheses.
    The second bullet would provide that, for purposes of determining
transaction fees and credits based on requirements based on quoting
levels, average daily volume (``ADV''), and consolidated ADV
(``CADV''), the Exchange may exclude shares traded any day that (1) the
Exchange is not open for the entire trading day and/or (2) a disruption
affects an Exchange system that lasts for more than 60 minutes during
regular trading hours. The second proposed bullet would reproduce the
language in footnote 6 of the current Price List.
Transaction Fees
    The Exchange proposes the following fees and credits for all
transactions in UTP Securities:
Liquidity Adding Non-Displayed Order Fees
    The Exchange does not propose to charge a fee for UTP executions on
the Exchange of non-displayed orders \7\ that add liquidity to the
Exchange in securities priced at or above $1.00.
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    \7\ These rates are client rates. The Exchange proposes separate
provide rates for non-displayed orders by SLPs, discussed below.
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    The Exchange also does not propose to charge a fee for UTP
executions on the Exchange of non-displayed orders that add liquidity
to the Exchange in securities priced below $1.00.
Liquidity Adding Displayed Order Credits and Fees
    For securities priced at or above $1.00, the Exchange proposes a
rebate of $0.0020 per share for UTP executions on the Exchange of
displayed orders that add liquidity to the Exchange.
    For UTP executions on the Exchange of displayed orders that add
liquidity to the Exchange by Floor brokers, the Exchange proposes a
rebate of $0.0026 per share.
    The Exchange does not propose to charge a fee for UTP executions on
the Exchange of displayed orders that add liquidity to the Exchange in
securities priced below $1.00.
    For securities priced at or above $1.00, the Exchange proposes a
credit of $0.0010 per share for UTP executions in each tape for MPL
orders that add liquidity to the Exchange, unless a specific credit for
SLP Provide Tiers or Adding Tiers applies.
    For securities priced at or above $1.00, the Exchange proposes a
rebate of $0.0006 per share for cross trades \8\ in UTP Securities that
add liquidity to the Exchange.
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    \8\ For purposes of the Price List, cross trades are trades
where a Floor broker executes customer orders to buy and sell an
equivalent amount of the same security pursuant to Rule 76.
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Liquidity Removing Order Fees
    For UTP executions on the Exchange that remove liquidity from the
Exchange, the Exchange proposes to charge $0.0030 per share for
securities priced at or above $1.00, including MPL Orders, unless the
Floor broker fee applies, and to charge 0.3% of the total dollar value
of the transaction for securities priced below $1.00.
    For Floor broker UTP executions that remove liquidity from the
Exchange, the Exchange proposes a fee $0.0026 per share for securities
priced at or above $1.00.

Adding and Remove Tiers for Securities at or Above $1.00
    The Exchange proposes tiered adding requirements for displayed
orders in securities priced at or above $1.00, as follows.
    Under the proposed Tier 1 Adding Credit, the Exchange would offer a
per tape credit of $0.0026 per share ($0.0025 if an MPL order) on a per
tape basis for transactions in stocks with a per share price of $1.00
or more when adding liquidity to the Exchange if the member
organization has at least 0.05% of Adding CADV in Tape B or C. For
purposes of qualifying for this tier, the 0.05% of Adding CADV could
include shares of both an SLP-Prop and an SLMM \9\ of the same or an
affiliated member organization. The Exchange also proposes to waive the
Tier 1 add and remove tier requirements until June 1, 2018, which would
be reflected in footnote *.
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    \9\ Under Rule 107B, a Supplemental Liquidity Provider (``SLP'')
can be either a proprietary trading unit of a member organization
(``SLP-Prop'') or a registered market maker at the Exchange
(``SLMM''). For purposes of the 10% average or more quoting
requirement in assigned securities pursuant to Rule 107B, quotes of
an SLP-Prop and an SLMM of the same member organization are not
aggregated. However, for purposes of adding liquidity for assigned
SLP securities in the aggregate, shares of both an SLP-Prop and an
SLMM of the same member organization are included.
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    Under the proposed Tier 2 Adding Credit, the Exchange would offer a
per tape credit of $0.0023 per share for transactions in stocks with a
per share price of $1.00 or more when adding liquidity to the Exchange
if the member organization has at least 0.01% of Adding CADV in Tape B
or C. For purposes of qualifying for this tier, the 0.01% of Adding
CADV could include shares of both an SLP-Prop and an SLMM of the same
or an affiliated member organization.
    Finally, for UTP Securities, the Exchange proposes to charge a per
tape fee of $0.0028 per share to remove liquidity from the Exchange for
member organizations with an Adding ADV \10\ of at least 50,000 shares
for that respective tape.
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    \10\ The phrase ``Adding ADV'' in the proposed tier would have a
citation to footnote 4 in the current Price List, which provides
``For purposes of transaction fees and Supplemental Liquidity
Provider liquidity credits, ADV calculations exclude early closing
days.'' The text of current footnote 4 would remain unchanged.
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SLP Provide Tiers
    The Exchange proposes tiered and non-tiered rates for displayed and
non-displayed orders by SLPs that add liquidity to the Exchange in UTP
Securities priced at or above $1.00, as follows:
Non-Tiered Rates
    For displayed orders in UTP Securities that add liquidity to the
Exchange, the Exchange proposes a non-tiered credit of $0.0026 per
share per tape in an assigned UTP Security where the SLP meets the 10%
average or more quoting requirement in an assigned security pursuant to
Rule 107B.\11\ For non-displayed orders in UTP Securities that add
liquidity to the Exchange, the Exchange proposes a non-tiered credit of
$0.0008 per share per tape in an assigned UTP Security if the SLP meets
the 10% average or more quoting requirement in an assigned security
pursuant to Rule 107B.
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    \11\ See note 9, supra.
---------------------------------------------------------------------------

Tier 2
    Proposed Tier 2 would provide a $0.0029 per share credit per tape
in an assigned UTP Security for SLPs adding displayed liquidity to the
Exchange if the SLP (1) adds liquidity for all assigned UTP Securities
in the aggregate of an CADV of at least 0.01% per tape, and meets the
10% average or more quoting requirement in 250 or more assigned UTP
Securities in Tapes B and C combined pursuant to Rule 107B, and (2)
meets the 10% average or more quoting requirement in an assigned UTP
Security pursuant to Rule 107B.
    Proposed Tier 2 would provide a $0.0011 per share credit per tape
in an assigned UTP Security for SLPs adding non-displayed liquidity to
the Exchange if the SLP meets the 10% average or more quoting
requirement in an assigned UTP Security pursuant to Rule 107B.
Tier 1
    Proposed Tier 1 would provide a $0.0032 per share credit per tape
in an assigned UTP Security for SLPs adding displayed liquidity to the
Exchange if the SLP (1) adds liquidity for all assigned UTP Securities
in the aggregate of an CADV of at least 0.05% per tape, and (2) meets
the 10% average or more quoting requirement in 500 or more assigned UTP
Securities in Tapes B and C combined pursuant to Rule 107B, and (2)
meets the 10% average or more quoting requirement in an assigned UTP
Security pursuant to Rule 107B.
    Proposed Tier 1 would provide a $0.0014 per share credit per tape
for SLPs adding non-displayed liquidity to the Exchange, and a $0.0025
per share credit for MPL Orders adding liquidity, in an assigned UTP
Security if the SLP meets the 10% average or more quoting requirement
in an assigned UTP Security pursuant to Rule 107B.
Tape A Tier
    The proposed Tape A Tier would provide a $0.00005 per share in an
assigned UTP Security in addition to the Tape A SLP credit in Tape A
assigned securities for SLPs adding displayed liquidity to the Exchange
if the SLP (1) qualifies for the SLP Tier 1 provide rate in both Tape B
and C or quotes in excess of the 10% average quoting requirement in 300
or more assigned securities separately in Tapes B and Tape C pursuant
to Rule 107B, and (2) where the SLP meets the 10% average quoting
requirement pursuant to Rule 107B.
    Finally, the Exchange proposes to waive the provide volume
component of the SLP Tier requirements until June 1, 2018, which would
be reflected in footnote **.
Routing Fees
    Under a new heading titled ``Routing Fees,'' the Exchange proposes
the following fees for routing, which would be applicable to all orders
in UTP Securities that are routed.
    For executions in securities with a price at or above $1.00 that
route to and execute in an auction on the Exchange's affiliate NYSE
American, the Exchange proposes to charge a fee of $0.0005 per share.
For executions in securities with a price at or above $1.00 that route
to and execute in an auction on an Away Market \12\ other than NYSE
American, the Exchange proposes to charge a fee of $0.0010 per share,
and a fee of $0.0030 per share for all other executions.
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    \12\ The term ``Away Market'' is defined in Rule 1.1(ff) to mean
any exchange, alternative trading system (``ATS'') or other broker-
dealer (1) with which the Exchange maintains an electronic linkage,
and (2) that provides instantaneous responses to orders routed from
the Exchange.
---------------------------------------------------------------------------

    For securities priced below $1.00 that route to and execute on an
Away Market, the Exchange proposes to charge a fee of 0.30% of the
total dollar value of the transaction for executions in an Away Market
auction as well as all other executions.
* * * * *
    The proposed changes are not otherwise intended to address any
other issues, and the Exchange is not aware of any problems that member
organizations would have in complying with the proposed change.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with Section 6(b) of the Act,\13\ in general, and furthers the
objectives of Sections 6(b)(4) and 6(b)(5) of the Act,\14\ in
particular, because it provides for the

equitable allocation of reasonable dues, fees, and other charges among
its members, issuers and other persons using its facilities and does
not unfairly discriminate between customers, issuers, brokers or
dealers.
---------------------------------------------------------------------------

    \13\ 15 U.S.C. 78f(b).
    \14\ 15 U.S.C. 78f(b)(4) & (5).
---------------------------------------------------------------------------

Adding Liquidity Credits and Fees
Liquidity Adding Non-Displayed Order Fees
    The Exchange believes that not charging a fee for liquidity adding
non-displayed orders in UTP Securities is reasonable, equitable and not
unfairly discriminatory because it is designed to facilitate execution
of, and enhance trading opportunities for, non-displayable orders,
thereby further incentivizing entry of non-displayed orders on the
Exchange. The Exchange notes that other markets charge fees for non-
displayed orders.\15\
---------------------------------------------------------------------------

    \15\ IEX, for instance, charges a fee of $0.0009 per share for
providing non-displayed liquidity for securities priced at or above
$1.00 and 0.30% of TDVT (i.e., the total dollar value of the
transaction calculated as the execution price) for securities below
$1.00. See Investors Exchange Fee Schedule 2017, available at
https://www.iextrading.com/trading/fees/.
---------------------------------------------------------------------------

Liquidity Adding Displayed Order Credits and Fees
    The Exchange believes that rebates of $0.0020 per share for UTP
executions on the Exchange of displayed orders that add liquidity to
the Exchange (unless another credit applies) and $0.0026 per share for
UTP executions on the Exchange of displayed orders that add liquidity
to the Exchange by Floor brokers are reasonable, equitable and not
unfairly discriminatory because it will encourage submission of
additional displayed liquidity to a public exchange, thereby promoting
price discovery and transparency.
    The Exchange further believes the proposed rebate for Floor brokers
is equitable and not unfairly discriminatory because it would continue
to encourage member organizations to send orders to the trading Floor
for execution, thereby contributing to robust levels of liquidity on
the trading Floor, which benefits all market participants. Further, the
proposed Floor broker credit is also equitable and not unfairly
discriminatory because those member organizations that make significant
contributions to market quality and that contribute to price discovery
by providing higher volumes of liquidity would be allocated a higher
credit. The Exchange believes that any member organizations that would
qualify for the proposed $0.0020 per share for UTP executions that add
liquidity could qualify for the higher rate based on the levels of
activity sent to Floor brokers. For the same reasons, the Exchange
believes the proposed credits for MPL orders and cross trades in UTP
Securities that add liquidity to the Exchange are reasonable and not
unfairly discriminatory.
    The Exchange believes that not charging UTP executions on the
Exchange of displayed orders that add liquidity to the Exchange in
securities priced below $1.00 would encourage price discovery and
enhance market quality by encouraging more competitive pricing of
displayed orders in low-priced UTP Securities. The Exchange believes
that not charging a fee for liquidity adding displayed orders is
equitable and not unfairly discriminatory because it is designed to
facilitate execution of, and enhance trading opportunities for,
displayable orders, thereby further incentivizing entry of displayed
orders on the Exchange.
Liquidity Removing Fees
    The Exchange believes that charging $0.0030 per share for
securities priced at or above $1.00, including MPL Orders unless the
Floor broker fee applies, and 0.3% of the total dollar value of the
transaction for securities priced below $1.00 for executions on the
Exchange in UTP Securities that remove liquidity is reasonable and
consistent with the Act. The Exchange notes that the proposed fees are
in line with the fees the Exchange currently charges for removing
liquidity from the Exchange in Tape A securities.\16\
---------------------------------------------------------------------------

    \16\ See page 5 of the current NYSE Price List, available at
https://www.nyse.com/publicdocs/nyse/markets/nyse/NYSE_Price_List.pdf.
---------------------------------------------------------------------------

Adding Tier Credits and Remove Tier Fees
    The Exchange believes that that the proposed tiered adding
requirements for displayed orders in securities priced at or above
$1.00 are reasonable, equitable and not unfairly discriminatory, as
follows.
    The proposed Tier 1 ($0.0026 per share, $0.0025 if an MPL order)
and Tier 2 ($0.0023 per share) Adding Credits per share for
transactions in UTP Securities with a per share stock price of $1.00 or
more when adding liquidity are reasonable because it would further
contribute to incenting member organizations to provide additional
amounts of liquidity on the Exchange. The Exchange believes that the
proposed Tier 1 and Tier 2 Adding Credits are reasonable, equitable and
not unfairly discriminatory because all member organizations would
benefit from such increased levels of liquidity. In addition, the Tier
1 and Tier 2 Adding Credits would provide a higher credit to member
organizations that is reasonably related to the value to the Exchange's
market quality associated with higher volumes of liquidity. In
addition, the Exchange believes that the proposed Tier 1 and Tier 2
Adding Credits are equitable and not unfairly discriminatory as all
similarly situated market participants will be subject to the same
credits on an equal and non-discriminatory basis.
    Further, the Exchange believes that proposed Tier 1 charge of
$0.0028 per share in UTP Securities for member organizations with an
Adding ADV of at least 50,000 shares that removes liquidity from the
Exchange is reasonable, equitable and not unfairly discriminatory
because the proposed fees are in line with the fees the Exchange
currently charges for removing liquidity from the Exchange in Tape A
securities.\17\
---------------------------------------------------------------------------

    \17\ See id.
---------------------------------------------------------------------------

    Finally, the Exchange believes it is reasonable and not unfairly
discriminatory to waive the Tier 1 requirements until June 1, 2018,
because the proposed credits and fees will apply to all similarly
situated member organizations.
SLP Provide Tiers
    The Exchange believes that higher rebates for SLPs discussed below
are reasonable, equitable and not unfairly discriminatory because SLPs
have monthly quoting requirements that non-SLP market participants do
not have. As discussed below, the Exchange believes that the proposed
rebates for SLPs are commensurate with the SLP's quoting requirement,
are consistent with rebates charged on other markets, and will
encourage the SLPs to add liquidity to the market in UTP Securities,
thereby providing customers with a higher quality venue for price
discovery, liquidity, competitive quotes and price improvement.
Non-Tiered Credits
    The Exchange believes that the proposed non-tiered credit of
$0.0026 per share for displayed orders, and the proposed non-tiered
credit of $0.0008 per share for non-displayed orders, for SLPs that add
liquidity to the Exchange are reasonable, equitable and not unfairly
discriminatory because, although slightly higher than the non-tiered
SLP rates applicable to Tape A securities, would encourage submission
of additional liquidity to a public

exchange, thereby promoting price discovery and transparency and
enhancing order execution opportunities for member organizations.
Tiers 1 and 2
    The Exchange believes the proposed credits for SLPs adding
displayed liquidity to the Exchange (proposed Tier 2 credit of $0.0029
per share and Tier 1 credit of $0.0032 per share) and non-displayed
liquidity to the Exchange (proposed Tier 2 credit of $0.0011 per share,
Tier 1 credit of $0.0014 per share credit, and $0.0025 per share credit
for MPL Orders), are reasonable, equitable and not unfairly
discriminatory because the proposed credits are in line with the fees
the Exchange currently charges SLPs for adding displayed and non-
displayed liquidity in Tape A securities.\18\
---------------------------------------------------------------------------

    \18\ See page 5 of the current NYSE Price List, available at
https://www.nyse.com/publicdocs/nyse/markets/nyse/NYSE_Price_List.pdf.
---------------------------------------------------------------------------

Tape A Tier
    The Exchange believes that proposed SLP Tier A Tier is reasonable
because it would provide SLPs with an additional way to qualify for a
rebate, thereby providing SLPs with greater flexibility and creating an
added incentive for SLPs to bring additional order flow to a public
market in UTP Securities.
    Finally, the Exchange believes it is reasonable and not unfairly
discriminatory to waive the provide volume component of the SLP Tier
requirements until June 1, 2018, because the proposed credits and fees
will apply to all similarly situated SLPs.
Routing Fees
    The Exchange believes that its proposed routing fees are a
reasonable, equitable and not an unfairly discriminatory allocation of
fees because the fee would be applicable to all member organizations in
an equivalent manner. Moreover, the proposed fees for routing shares
are also reasonable, equitable and not unfairly discriminatory because
they are consistent with fees charged on other exchanges. In
particular, the Exchange's proposal to charge a fee of $0.0005 per
share for executions that route to and execute on an NYSE American
auction in securities priced at or above $1.00 is the same as the fee
charged by the Exchange's affiliate NYSE Arca, Inc. (``NYSE Arca''), to
route orders to NYSE American auctions.\19\ Moreover, the Exchange
believes that the proposed $0.0005 per share routing fee is reasonable
and not unfairly discriminatory because it is the same as NYSE
American's fee for executions in the opening and closing auctions.\20\
The Exchange notes that the proposed $0.0005 routing fee is at least
half the base rate charged for auction orders on most other markets,
including the NYSE.\21\
---------------------------------------------------------------------------

    \19\ See page 4 of the NYSE Arca, Inc., Schedule of Fees and
Charges, available at https://www.nyse.com/publicdocs/nyse/markets/nyse-arca/NYSE_Arca_Marketplace_Fees.pdf.
    \20\ See page 1 of NYSE American's Price List, available at
https://www.nyse.com/publicdocs/nyse/markets/nyse-american/NYSE_America_Equities_Price_List.pdf.
    \21\ The NYSE's base rate is $0.0010. See note 18, supra. The
NASDAQ Stock Market's (``NASDAQ'') base rate, in contrast, is
$0.0016. See note 22, infra.
---------------------------------------------------------------------------

    The proposal to charge $0.0010 per share for executions that route
to and execute on Away Market auctions other than NYSE American in
securities priced at or above $1.00 is reasonable and not unfairly
discriminatory because it is consistent with fees charged on other
exchanges. The Exchange notes that the proposed fee is the same, and in
some cases lower than, the fees charged on other exchanges.\22\
---------------------------------------------------------------------------

    \22\ For example, NASDAQ charges a rate of $0.0016 per executed
share for Tier F. See NASDAQ Fee Schedule at http://www.nasdaqtrader.com/Trader.aspx?id=PriceListTrading2.
---------------------------------------------------------------------------

    The proposal to charge $0.0030 for all other executions in
securities priced at or above $1.00 that route to and execute on Away
Market auctions is reasonable, equitable and not unfairly
discriminatory because it is consistent with fees charged on other
exchanges.\23\
---------------------------------------------------------------------------

    \23\ For example, NASDAQ charges a rate of $0.0030 to remove
liquidity for shares executed at or above $1.00. See NASDAQ Fee
Schedule at http://www.nasdaqtrader.com/Trader.aspx?id=PriceListTrading2.
---------------------------------------------------------------------------

    Further, the proposal to charge a fee of 0.30% of total dollar
value for transactions in securities with a price under $1.00 are
reasonable, equitable and not unfairly discriminatory because it is
consistent with fees charged on other exchanges.\24\
---------------------------------------------------------------------------

    \24\ NASDAQ, for example, charges a fee of 0.30% (i.e. 30 basis
points) of total dollar volume to remove liquidity for shares
executed below $1.00. See NASDAQ Fee Schedule at http://www.nasdaqtrader.com/Trader.aspx?id=PriceListTrading2.
---------------------------------------------------------------------------

    Finally, the Exchange notes that it operates in a highly
competitive market in which market participants can readily favor
competing venues if they deem fee levels at a particular venue to be
excessive or rebate opportunities available at other venues to be more
favorable. In such an environment, the Exchange must continually adjust
its fees and rebates to remain competitive with other exchanges and
with alternative trading systems that have been exempted from
compliance with the statutory standards applicable to exchanges.
Because competitors are free to modify their own fees and credits in
response, and because market participants may readily adjust their
order routing practices, the Exchange believes that the degree to which
fee changes in this market may impose any burden on competition is
extremely limited. As a result of all of these considerations, the
Exchange does not believe that the proposed changes will impair the
ability of member organizations or competing order execution venues to
maintain their competitive standing in the financial markets.

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

    In accordance with Section 6(b)(8) of the Act,\25\ the Exchange
believes that the proposed rule change would not impose any burden on
competition that is not necessary or appropriate in furtherance of the
purposes of the Act. Instead, the Exchange believes that the proposed
changes would encourage the submission of additional liquidity to a
public exchange, thereby promoting price discovery and transparency and
enhancing order execution opportunities for member organizations. The
Exchange believes that this could promote competition between the
Exchange and other execution venues, including those that currently
offer similar order types and comparable transaction pricing, by
encouraging additional orders to be sent to the Exchange for execution.
The Exchange believes that providing higher rebates and credits to SLPs
and Floor brokers could similarly promote competition because the
higher rates would encourage submission of additional liquidity by
member organizations with enhanced quoting obligations (SLPs) and those
that make significant contributions to market quality and contribute to
price discovery by providing higher volumes of liquidity (Floor
brokers).
---------------------------------------------------------------------------

    \25\ 15 U.S.C. 78f(b)(8).
---------------------------------------------------------------------------

    Finally, the Exchange notes that it operates in a highly
competitive market in which market participants can readily favor
competing venues if they deem fee levels at a particular venue to be
excessive or rebate opportunities available at other venues to be more
favorable. In such an environment, the Exchange must continually adjust
its fees and rebates to remain competitive with other exchanges and
with alternative trading systems that have been exempted from
compliance with the statutory standards applicable to exchanges.
Because competitors are free to modify their own fees and credits in

response, and because market participants may readily adjust their
order routing practices, the Exchange believes that the degree to which
fee changes in this market may impose any burden on competition is
extremely limited. As a result of all of these considerations, the
Exchange does not believe that the proposed changes will impair the
ability of member organizations or competing order execution venues to
maintain their competitive standing in the financial markets.

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

    No written comments were solicited or received with respect to the
proposed rule change.

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

    The foregoing rule change is effective upon filing pursuant to
Section 19(b)(3)(A) \26\ of the Act and subparagraph (f)(2) of Rule
19b-4 \27\ thereunder, because it establishes a due, fee, or other
charge imposed by the Exchange.
---------------------------------------------------------------------------

    \26\ 15 U.S.C. 78s(b)(3)(A).
    \27\ 17 CFR 240.19b-4(f)(2).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of such proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission shall institute proceedings under
Section 19(b)(2)(B) \28\ of the Act to determine whether the proposed
rule change should be approved or disapproved.
---------------------------------------------------------------------------

    \28\ 15 U.S.C. 78s(b)(2)(B).
---------------------------------------------------------------------------

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 protected]. Please include
File Number SR-NYSE-2018-15 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NYSE-2018-15. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (http://www.sec.gov/rules/sro.shtml).
Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for website viewing and printing in
the Commission's Public Reference Room, 100 F Street NE, Washington, DC
20549 on official business days between the hours of 10:00 a.m. and
3:00 p.m. Copies of the filing also will be available for inspection
and copying at the principal office of the Exchange. All comments
received will be posted without change. Persons submitting comments are
cautioned that we do not redact or edit personal identifying
information from comment submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File Number SR-NYSE-2018-15 and should be submitted on
or before May 23, 2018.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\29\
---------------------------------------------------------------------------

    \29\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2018-09258 Filed 5-1-18; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 84, Number 224 (Wednesday, November 20, 2019)]
[Notices]
[Page 64059]
[FR Doc No: 2019-25146]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER20-370-000]

City Power & Gas, LLC; Supplemental Notice That Initial Market-
Based Rate Filing Includes Request for Blanket Section 204
Authorization

    This is a supplemental notice in the above-referenced proceeding of
City Power & Gas, LLC's application for market-based rate authority,
with an accompanying rate tariff, noting that such application includes
a request for blanket authorization, under 18 CFR part 34, of future
issuances of securities and assumptions of liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street NE, Washington,
DC 20426, in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone
filing a motion to intervene or protest must serve a copy of that
document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is December 4, 2019.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
5 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First Street NE, Washington, DC 20426.
    The filings in the above-referenced proceeding are accessible in
the Commission's eLibrary system by clicking on the appropriate link in
the above list. They are also available for electronic review in the
Commission's Public Reference Room in Washington, DC. There is an
eSubscription link on the website that enables subscribers to receive
email notification when a document is added to a subscribed docket(s).
For assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.

    Dated: November 14, 2019.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2019-25146 Filed 11-19-19; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 78, Number 1 (Wednesday, January 2, 2013)]
[Notices]
[Pages 101-102]
[FR Doc No: 2012-31476]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-D-0524]

Guidance for Industry and Food and Drug Administration Staff;
Acceptance and Filing Reviews for Premarket Approval Applications;
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the guidance entitled ``Acceptance and Filing Reviews
for Premarket Approval Applications (PMAs).'' The purpose of the
acceptance and filing reviews is to make a threshold determination
about whether an application is administratively complete. This
guidance document is intended to clarify the criteria for accepting and
filing a PMA, thereby assuring the consistency of our acceptance and
filing decisions. This guidance is applicable to original PMAs and PMA
panel-track supplements reviewed in the Center for Devices and
Radiological Health (CDRH) and the Center for Biologics Evaluation and
Research (CBER).

DATES: Submit either electronic or written comments on this guidance at
any time. General comments on Agency guidance documents are welcome at
any time.

ADDRESSES: Submit written requests for single copies of the guidance
document entitled ``Acceptance and Filing Reviews for Premarket
Approval Applications (PMAs)'' to the Division of Small Manufacturers,
International and Consumer Assistance, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, rm. 4613, Silver Spring, MD 20993-0002; or Office of
Communication, Outreach and Development (HFM-40), Center for Biologics
Evaluation and Research (CBER), Food and Drug Administration, 1401
Rockville Pike, suite 200N, Rockville, MD 20852-1448. Send one self-
addressed adhesive label to assist that office in processing your
request, or fax your request to<PHONE_NUMBER>. See the SUPPLEMENTARY
INFORMATION section for information on electronic access to the
guidance.
    Submit electronic comments on the 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. Identify comments with the docket number
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT:
Nicole Wolanski, 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>; or
Stephen Ripley, Center for Biologics Evaluation and Research (HFM-17),
Food and Drug Administration, 1401 Rockville Pike, suite 200N,
Rockville, MD 20852-1448,<PHONE_NUMBER>.

I. Background

    The PMA regulation (21 CFR 814.42(e)) identifies the criteria that,
if not met, may serve as a basis for refusing to file a PMA. These
criteria are discussed in the guidance document ``Guidance for Industry
and FDA Staff Premarket Approval Application Filing Review,'' dated May
1, 2003. This document has been used by FDA staff and the device
industry to help elucidate the broad preclinical and clinical issues
that need to be addressed in a PMA and the key decisions to be made
during the filing process. The guidance entitled ``Acceptance and
Filing Reviews for Premarket Approval Applications (PMAs)'' supersedes
the guidance entitled ``Guidance for Industry and FDA Staff Premarket
Approval Application Filing Review.''
    To further focus the Agency's review resources on complete
applications, which will provide a more efficient approach to ensuring
that devices that have a reasonable assurance of safety

and effectiveness reach patients as quickly as possible, we have
modified the PMA filing guidance. In this guidance entitled,
``Acceptance and Filing Reviews for Premarket Approval Applications
(PMAs),'' we have separated the requirements for PMA filing into: (1)
Acceptance criteria and (2) filing criteria. Acceptance review involves
an early assessment of the completeness of the application, and
informing the applicant in a written response within the first 15
calendar days of receipt of the application whether any administrative
elements are missing, and if so, identifying the missing administrative
element(s).
    In order to enhance the consistency of our acceptance and filing
decisions and to help applicants understand the types of information
FDA needs to conduct a substantive review of a PMA, this guidance and
associated checklist clarify the necessary elements and contents of a
complete PMA application. The process we outline is applicable to all
devices reviewed in a PMA application. Acceptance and filing decisions
will be made for all original PMA applications and panel-track PMA
supplements.
    This guidance is not significantly different from the 2003 PMA
guidance document. The ``preliminary questions'' remain the same and
the ``filing review questions'' have been separated into ``acceptance
decision questions'' (i.e., is the file administratively complete) and
``filing decision questions'' (i.e., are data consistent with protocol,
final device design, and proposed indications). In addition, it should
be noted that this document is focused on the regulatory and scientific
criteria for making an ``Accept'' or ``Refuse to Accept'' decision as
well as ``File'' or ``Not File'' decision for a PMA. It specifically
does not alter the following administrative aspects of the PMA filing
process: (1) The time frame for the filing review phase (i.e., 45
days); (2) the processes for document tracking, distribution, and
handling; and (3) the procedures for assembling the review team and
setting up the filing meeting.
    In the Federal Register of July 31, 2012 (77 FR 45357), FDA
announced the availability of the draft guidance document. Interested
persons were invited to comment by September 14, 2012. Nine comments
were received with multiple recommendations pertaining to the
administrative processes and policies regarding acceptance and filing
review decisions. In response to these comments, FDA revised the
guidance document to clarify the processes and policies as appropriate.
This guidance supersedes the guidance entitled ``Guidance for Industry
and FDA Staff Premarket Approval Application Filing Review,'' dated May
1, 2003.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
Agency's current thinking on acceptance and filing reviews for PMAs. 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 statute
and regulations.

III. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so by
using the Internet. A search capability for all CDRH guidance documents
is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance
documents are also available at http://www.regulations.gov or from the
CBER internet site at http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm. To receive
``Acceptance and Filing Reviews for Premarket Approval Applications
(PMAs),'' you may either send an email request to<EMAIL_ADDRESS>to
receive an electronic copy of the document or send a fax request to
301-847-8149 to receive a hard copy. Please use the document number
1792 to identify the guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    This guidance refers to currently approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR part 814, subpart B, have been
approved under OMB control number 0910-0231.

V. Comments

    Interested persons may submit either written comments regarding
this document to the Division of Dockets Management (see ADDRESSES) or
electronic comments to http://www.regulations.gov. 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.

    Dated: December 26, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-31476 Filed 12-31-12; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 76, Number 250 (Thursday, December 29, 2011)]
[Notices]
[Page 81929]
[FR Doc No: 2011-33307]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 199-205]

South Carolina Public Service Authority; Notice of Workshop for
Santee Cooper Hydroelectric Project

    On May 26 and November 8, 2011, Commission staff met with
representatives of the National Marine Fisheries Service (NMFS) and the
South Carolina Public Service Authority (SCPSA), licensee for the
Santee-Cooper Hydroelectric Project No. 199, to discuss what is needed
to complete formal consultation for shortnose sturgeon (Acipenser
brevirostrum) under section 7 of the Endangered Species Act (ESA). At
the November 8, 2011 meeting, the parties agreed that additional
dialogue was necessary to understand the project, its operations, and
the technical feasibility of implementing measures at the project's two
developments. Accordingly, Commission staff will meet with
representatives of NMFS and SCPSA on Wednesday and Thursday, January 11
and 12, 2012, respectively. The focus of each day is as follows:
    a. January 11 will be devoted to touring and discussing ESA issues
at Wilson Dam, and for the Santee River and the Re-Diversion Canal; and
    b. January 12 will be devoted to touring and discussing issues at
Pinopolis (Jefferies Station) and the U.S. Army Corps of Engineers'
(Corps) St. Stephen Project.
    Each day will begin at 9 a.m. at SCPSA's headquarters, located at 1
Riverwood Drive, Moncks Corner, South Carolina. Participation at the
workshop will be limited to Commission staff, NMFS, SCPSA, and the
Corps; all local, state, and federal agencies, and interested parties,
are invited to attend. Questions concerning the workshop should be
directed to John Inabinet of SCPSA at<PHONE_NUMBER>. The workshop is
posted on the Commission's calendar located at http://www.ferc.gov/EventCalendar/EventsList.aspx, along with other related information.
    For further information, contact Allan Creamer at<PHONE_NUMBER>,
or by email at<EMAIL_ADDRESS>
    Dated: December 21, 2011.
Kimberly D. Bose,
Secretary.
[FR Doc. 2011-33307 Filed 12-28-11; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 88, Number 241 (Monday, December 18, 2023)]
[Notices]
[Page 87435]
[FR Doc No: 2023-27662]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-5344]

Pharmacyclics LLC.; Withdrawal of Approval of Indications for
Mantle Cell Lymphoma and Marginal Zone Lymphoma for IMBRUVICA
(ibrutinib) Capsules and Tablets

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
that it is withdrawing approval of the indications for mantle cell
lymphoma (MCL) and marginal zone lymphoma (MZL) for IMBRUVICA
(ibrutinib) Capsules and Tablets approved, respectively, under new drug
applications (NDAs) 205552 and 210563. These NDAs are held by
Pharmacyclics LLC, 1000 Gateway Blvd., South San Francisco, CA 94080
(Pharmacyclics). Pharmacyclics voluntarily requested that the Agency
withdraw approval of these indications and waived its opportunity for a
hearing.

DATES: Approval is withdrawn as of December 18, 2023.

FOR FURTHER INFORMATION CONTACT: Kimberly Lehrfeld, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6226, Silver Spring, MD 20993-0002, 301-
796-3137, [email protected].

SUPPLEMENTARY INFORMATION: On November 13, 2013, FDA approved NDA
205552 for IMBRUVICA (ibrutinib) Capsules for the treatment of adult
patients with MCL who have received at least one prior therapy (the MCL
indication). On January 18, 2017, FDA approved a prior approval
supplement for NDA 205552 for IMBRUVICA (ibrutinib) Capsules for the
treatment of adult patients with MZL who require systemic therapy and
have received at least one prior anti-CD20-based therapy (the MZL
indication). On February 16, 2018, FDA approved NDA 210563 for
IMBRUVICA (ibrutinib) Tablets, a new dosage form of IMBRUVICA
(ibrutinib), for the MCL and MZL indications. FDA approved the MCL and
MZL indications for both products under the Agency's accelerated
approval regulations, 21 CFR part 314, subpart H. As a condition of
accelerated approval of IMBRUVICA (ibrutinib) Capsules and Tablets for
the MCL and MZL indications, the applicant was required to conduct
postmarketing trials to verify the clinical benefit of ibrutinib for
the MCL and MZL indications.
    On February 8, 2023, FDA met with Pharmacyclics to inform the
applicant of the plans to convene the Oncologic Drugs Advisory
Committee regarding the accelerated approvals for the MCL and MZL
indications because the required postmarketing trials did not verify
the clinical benefit of ibrutinib for these indications. On March 21,
2023, FDA met with Pharmacyclics to discuss the applicant's request to
voluntarily withdraw approval of the MCL and MZL indications for
IMBRUVICA (ibrutinib) Capsules and Tablets. On April 6, 2023,
Pharmacyclics submitted a letter requesting withdrawal of the MCL and
MZL indications for IMBRUVICA (ibrutinib) Capsules and Tablets pursuant
to Sec.  314.150(d) (21 CFR 314.150(d)) and waiving its opportunity for
a hearing.
    Therefore, under Sec.  314.150(d), approvals of the MCL and MZL
indications for IMBRUVICA (ibrutinib) Capsules and Tablets are
withdrawn as of December 18, 2023. Withdrawal of approval of these
indications does not affect any other approved indication for IMBRUVICA
(ibrutinib) Capsules and Tablets.

    Dated: December 12, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-27662 Filed 12-15-23; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: March 25, 2008 (Volume 73, Number 58)]
[Rules and Regulations]
[Page 15672-15674]
[DOCID:fr25mr08-8]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R02-OAR-2008-0078; FRL-8546-2]

Determinations of Attainment of the Eight-Hour Ozone Standard for
Various Ozone Nonattainment Areas in Upstate New York State

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: The EPA is determining that three ozone nonattainment areas in
New York, the Albany-Schenectady-Troy, Jefferson County and Rochester
areas, have attained the 8-hour National Ambient Air Quality Standard
(NAAQS) for ozone. This determination is based upon certified ambient
air monitoring data that show each area has monitored attainment of the
8-hour ozone NAAQS based on complete, quality-assured ambient air
monitoring data for the three year period ending in 2006. In addition,
data for 2007 show that the areas continue to attain the standard. This
determination suspends any applicable requirements for these areas to
submit an attainment demonstration, a reasonable further progress plan,
contingency measures, and other planning State Implementation Plans
related to attainment of the 8-hour ozone NAAQS. These requirements
shall remain suspended for so long as these areas continue to attain
the ozone NAAQS. New York proposed that Essex County had also attained
the 8-hour ozone standard, but because of incomplete data, a
determination of attainment cannot be made at this time.

DATES: Effective Date: This rule is effective on March 25, 2008.

ADDRESSES: EPA has established a docket for this action under Docket
Identification No. EPA-R02-OAR-2008-0078. All documents in the docket
are listed on the http://www.regulations.gov Web site. Although listed
in the index, some information is not publicly available, i.e., CBI or
other information whose disclosure is restricted by statute. Certain
other material, such as copyrighted material, is not placed on the
Internet and will be publicly available only in hard copy form.
Publicly available docket materials are available either electronically
through http://www.regulations.gov or in hard copy at the Air Programs
Branch, U.S. Environmental Protection Agency, Region 2, 290 Broadway,
25th Floor, New York, New York 10007-1866. To make your visit as
productive as possible, contact the person listed in the FOR FURTHER
INFORMATION CONTACT section to schedule your inspection. The Regional
Office's official hours of business are Monday through Friday, 8:30 to
4:30, excluding legal holidays.

FOR FURTHER INFORMATION CONTACT: Robert F. Kelly, Air Programs Branch,
Environmental Protection Agency, Region 2, 290 Broadway, 25th Floor,
New York, New York 10007-1866, telephone number<PHONE_NUMBER>, fax
number<PHONE_NUMBER>, e-mail<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Table of Contents

I. EPA's Action
II. The Effect of EPA's Action
III. The Effective Date of EPA's Action
IV. Final Action
V. Statutory and Executive Order Reviews

I. EPA's Action

    EPA is determining that the Albany-Schenectady-Troy, Jefferson
County and Rochester 8-hour ozone nonattainment areas have attained the
8-hour National Ambient Air Quality Standard (NAAQS) for ozone. These
determinations are based upon certified ambient air monitoring data
that show the areas have monitored attainment of the ozone NAAQS for
the three-year period from 2004 to 2006. In addition, based on quality
controlled and quality assured ozone data, these areas continued to
attain the ozone NAAQS in 2007, the most recent year of data available.
All these data are available in the EPA Air Quality System (AQS)
database. Essex County did not have enough complete data to make a
determination of attainment at this time.
    Other specific requirements of the determination and the rationale
for EPA's proposed action are explained in the Notice of Proposed
Rulemaking (NPR) published on February 14, 2008 (73 FR 8638) and will
not be restated here. No public comments were received on the NPR.

II. The Effect of EPA's Action

    Under the provisions of EPA's ozone implementation rule (see 40 CFR
51.918), this determination suspends the requirements for the Albany-
Schenectady-Troy, Jefferson County and Rochester ozone nonattainment
areas to submit an attainment demonstration, a reasonable further
progress plan, section 172(c)(9) contingency measures, and any other
planning State Implementation Plans (SIPs) related to attainment of the
8-hour ozone NAAQS for so long as these areas continue to attain the
ozone NAAQS.
    This action does not constitute a redesignation to attainment under
Clean Air Act (CAA) section 107(d)(3), because these areas do not have
approved maintenance plans as required under section 175A of the CAA,
nor are there determinations that the areas have met the other
requirements for redesignation. The classification and designation
status of these areas will not change from nonattainment for the 8-hour
ozone NAAQS until such time as EPA determines that they meet the CAA
requirements for redesignation to attainment.
    If EPA subsequently determines, after notice-and-comment rulemaking
in the Federal Register, that any of these areas has violated the
current 8-hour ozone standard, the basis for the suspension of these
requirements would no longer exist for that area, and the area that
violated the 8-hour standard would have to address the pertinent
requirements.

III. The Effective Date of EPA's Action

    EPA finds that there is good cause for this approval to become
effective on the date of publication of this action in the Federal
Register, because a delayed effective date is unnecessary due to the
nature of the approval. The expedited effective date for this action is
authorized under both 5 U.S.C. 553(d)(1), which provides that rule
actions may become effective less than 30 days after publication if the
rule ``grants or recognizes an exemption or relieves a restriction''
and 5 U.S.C. 553(d)(3), which allows an effective date less than 30
days after publication ``as otherwise provided by the agency for good
cause found and published with the rule.'' As noted above, this
determination of attainment suspends the requirements for New York to
submit attainment demonstrations, reasonable further progress plans,
section 172(c)(9) contingency measures, and any other planning SIPs
related to attainment of the 8-hour ozone NAAQS in each of these areas
for so long as an area continues to attain the ozone NAAQS. The
suspension of these requirements is sufficient reason to allow an
expedited effective date of this rule under 5 U.S.C. 553(d)(1). In
addition, New York's suspension from these requirements provides good
cause to make this rule effective on the date

of publication of this action in the Federal Register, pursuant to 5
U.S.C. 553(d)(3). The purpose of the 30-day waiting period prescribed
in 5 U.S.C. 553(d) is to give affected parties a reasonable time to
adjust their behavior and prepare before the final rule takes effect.
Where, as here, the final rule suspends requirements rather than
imposing obligations, affected parties, such as the State of New York,
do not need time to adjust and prepare before the rule takes effect.

IV. Final Action

    EPA is determining that the Albany-Schenectady-Troy, Jefferson
County and Rochester 8-hour ozone nonattainment areas have attained the
8-hour ozone standard and continue to attain the standard based on data
through the 2007 ozone season. As provided in 40 CFR 51.918, this
determination suspends the requirements for New York to submit
attainment demonstrations, reasonable further progress plans, and
contingency measures under section 172(c)(9), and any other planning
SIP related to attainment of the 8-hour ozone NAAQS for these areas. If
one or more of these areas no longer attains the standard, that area or
areas would have to submit the required SIP planning elements required
by the CAA for each particular area. EPA is codifying this
determination in 40 CFR 52.1683 as a new paragraph (f)(2). The existing
text of paragraph (f) has been designated as (f)(1) without any
changes.

V. Statutory and Executive Order Reviews

    Under Executive Order 12866 (58 FR 51735, October 4, 1993), this
action is not a ``significant regulatory action'' and therefore is not
subject to review by the Office of Management and Budget. For this
reason, this action is also not subject to Executive Order 13211,
``Actions Concerning Regulations That Significantly Affect Energy
Supply, Distribution, or Use'' (66 FR 28355, May 22, 2001). This action
makes a determination based on air quality data, and results in the
suspension of certain Federal requirements. Accordingly, the
Administrator certifies that this rule will not have a significant
economic impact on a substantial number of small entities under the
Regulatory Flexibility Act (5 U.S.C. 601 et seq.). Because this rule
makes a determination based on air quality data, and results in the
suspension of certain Federal requirements, it does not contain any
unfunded mandate or significantly or uniquely affect small governments,
as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-
4).
    This rule also does not have tribal implications because it will
not have a substantial direct effect on one or more Indian tribes, on
the relationship between the Federal Government and Indian tribes, or
on the distribution of power and responsibilities between the Federal
Government and Indian tribes, as specified by Executive Order 13175 (65
FR 67249, November 9, 2000). This action also does not have Federalism
implications because it does not have substantial direct effects on the
States, on the relationship between the national government and the
States, or on the distribution of power and responsibilities among the
various levels of government, as specified in Executive Order 13132 (64
FR 43255, August 10, 1999), because it merely makes a determination
based on air quality data and results in the suspension of certain
Federal requirements, and does not alter the relationship or the
distribution of power and responsibilities established in the Clean Air
Act. This rule also is not subject to Executive Order 13045
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997), because it determines that air
quality in the affected area is meeting Federal standards.
    The requirements of section 12(d) of the National Technology
Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do not apply
because it would be inconsistent with applicable law for EPA, when
determining the attainment status of an area, to use voluntary
consensus standards in place of promulgated air quality standards and
monitoring procedures that otherwise satisfy the provisions of the
Clean Air Act.
    This rule does not impose an information collection burden under
the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
et seq.)
    Under Executive Order 12898, EPA finds that this rule involves a
determination of attainment based on air quality data and will not have
disproportionately high and adverse human health or environmental
effects on any communities in the area, including minority and low-
income communities.
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit 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. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the Clean Air Act, petitions for
judicial review of this action must be filed in the United States Court
of Appeals for the appropriate circuit by May 27, 2008. Filing a
petition for reconsideration by the Administrator of this final rule
does not affect the finality of this rule for the purposes of judicial
review nor does it extend the time within which a petition for judicial
review may be filed, and shall not postpone the effectiveness of such
rule or action. This action may not be challenged later in proceedings
to enforce its requirements. (See section 307(b)(2).)

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Carbon monoxide,
Incorporation by reference, Intergovernmental relations, Nitrogen
dioxide, Ozone, Reporting and recordkeeping requirements, Volatile
organic compounds.

    Dated: March 18, 2008.
Alan J. Steinberg,
Regional Administrator, Region 2.

0
Part 52 of chapter I, title 40 of the Code of Federal Regulations is
amended as follows:

PART 52--[AMENDED]

0
1. The authority citation for part 52 continues to read as follows:

    Authority: 42 U.S.C. 7401 et seq.

Subpart HH--New York

0
2. Section 52.1683 is amended by revising paragraph (f) to read as
follows:

Sec.  52.1683  Control strategy: Ozone.

* * * * *
    (f) Attainment Determination. (1) EPA has determined that, as of
February 5, 1998, the Poughkeepsie ozone nonattainment area (consisting
of Dutchess and Putnam Counties and northern Orange County) has air
monitoring data that attains the one-hour ozone standard and that the
requirements of section 182(b)(1) (reasonable further progress and
attainment demonstration) and related requirements of section 172(c)(9)
(contingency measures) of the Clean Air Act do not apply to the area.

    (2) EPA is determining that the 8-hour ozone nonattainment areas in
New York listed below have attained the 8-hour ozone standard on the
date listed. Under the provisions of EPA's ozone implementation rule
(see 40 CFR 51.918), this determination suspends the reasonable further
progress and attainment demonstration requirements of section 182(b)(1)
and related requirements of section 172(c)(9) of the Clean Air Act for
each of these areas as long as the area does not monitor any violations
of the 8-hour ozone standard. If a violation of the ozone NAAQS is
monitored this determination shall no longer apply in the area where
the violation occurs.
    (i) Albany-Schenectady-Troy (consisting of Albany, Greene,
Montgomery, Rensselaer, Saratoga, Schenectady, and Schoharie Counties)
as of March 25, 2008,
    (ii) Jefferson County, as of March 25, 2008, and
    (iii) Rochester (consisting of Genesee, Livingston, Monroe,
Ontario, Orleans and Wayne Counties) as of March 25, 2008.
* * * * *
 [FR Doc. E8-6027 Filed 3-24-08; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register Volume 83, Number 123 (Tuesday, June 26, 2018)]
[Notices]
[Pages 29779-29780]
[FR Doc No: 2018-13596]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #1

    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER13-738-005; ER11-3097-009; ER10-1186-008; ER10-
1329-008.
    Applicants: DTE Electric Company, DTE Energy Trading, Inc., DTE
Energy Supply, Inc., St. Paul Cogeneration, LLC.
    Description: Updated Market Power Analysis for the Central Region
of the DTE MBR Entities, et al.
    Filed Date: 6/18/18.
    Accession Number: 20180618-5134.
    Comments Due: 5 p.m. ET 8/17/18.

    Docket Numbers: ER14-1619-004.
    Applicants: Cottonwood Energy Company LP.
    Description: Supplement (Clarification) to May 11, 2018 Cottonwood
Energy Company LP tariff filing.
    Filed Date: 6/18/18.
    Accession Number: 20180618-5142.
    Comments Due: 5 p.m. ET 7/9/18.

    Docket Numbers: ER17-219-007.
    Applicants: PacifiCorp.
    Description: Compliance filing: OATT Ancillary Erratum to
Compliance Filing in ER17-219 to be effective 7/1/2018.
    Filed Date: 6/15/18.
    Accession Number: 20180615-5243.
    Comments Due: 5 p.m. ET 7/6/18.

    Docket Numbers: ER17-2088-001: ER16-2035-001; ER16-1833-003; ER14-
474-008.
    Applicants: Apple Blossom Wind, LLC, Black Oak Wind, LLC, Sempra
Gas & Power Marketing, LLC, Sempra Generation, LLC.
    Description: Updated Market Power Analysis for the Central Region
of Apple Blossom Wind, LLC, et al.
    Filed Date: 6/18/18.
    Accession Number: 20180618-5138.
    Comments Due: 5 p.m. ET 8/17/18.

    Docket Numbers: ER18-1190-001.
    Applicants: Entergy Arkansas, Inc.
    Description: Tariff Amendment: Amended Distribution Agreement to
Reflect Tax Cuts and Jobs Act of 2017 to be effective 6/1/2018.
    Filed Date: 6/19/18.
    Accession Number: 20180619-5019.
    Comments Due: 5 p.m. ET 7/10/18.

    Docket Numbers: ER18-1267-002.
    Applicants: South Central MCN LLC.
    Description: Tariff Amendment: SCMCN ER18-1267 Deficiency Filing
Part 1 to be effective 3/31/2018.
    Filed Date: 6/18/18.
    Accession Number: 20180618-5089.
    Comments Due: 5 p.m. ET 6/28/18.

    Docket Numbers: ER18-1267-003.
    Applicants: South Central MCN LLC.
    Description: Tariff Amendment: SCMCN ER18-1267 Deficiency Filing
Part 2 to be effective 3/31/2018.
    Filed Date: 6/18/18.

    Accession Number: 20180618-5090.
    Comments Due: 5 p.m. ET 6/28/18.

    Docket Numbers: ER18-1424-001.
    Applicants: Rio Bravo Fresno, A California Joint Venture.
    Description: Tariff Amendment: Amendment to 1 to be effective 4/23/
2018.
    Filed Date: 6/19/18.
    Accession Number: 20180619-5002.
    Comments Due: 5 p.m. ET 7/10/18.

    Docket Numbers: ER18-1427-001.
    Applicants: Rio Bravo Rocklin, A California Joint Venture.
    Description: Tariff Amendment: Amendment to 1 to be effective 4/23/
2018.
    Filed Date: 6/19/18.
    Accession Number: 20180619-5000.
    Comments Due: 5 p.m. ET 7/10/18.

    Docket Numbers: ER18-1534-001.
    Applicants: East Hampton Energy Storage Center, LLC.
    Description: Tariff Amendment: East Hampton Energy Storage Center,
LLC Amendment to App for Market-Based Rates to be effective 7/6/2018.
    Filed Date: 6/18/18.
    Accession Number: 20180618-5109.
    Comments Due: 5 p.m. ET 6/28/18.

    Docket Numbers: ER18-1535-001.
    Applicants: Montauk Energy Storage Center, LLC.
    Description: Tariff Amendment: Montauk Energy Storage Center, LLC
Amendment to App for Market-Based Rates to be effective 7/6/2018.
    Filed Date: 6/18/18.
    Accession Number: 20180618-5111.
    Comments Due: 5 p.m. ET 6/28/18.

    Docket Numbers: ER18-1577-001.
    Applicants: Thunder Spirit Wind, LLC.
    Description: Tariff Amendment: Supplement to Market-Based Rate
Application to be effective 5/14/2018.
    Filed Date: 6/15/18.
    Accession Number: 20180615-5244.
    Comments Due: 5 p.m. ET 7/6/18.

    Docket Numbers: ER18-1781-001.
    Applicants: Southwest Power Pool, Inc.
    Description: Tariff Amendment: 2041R7 Kansas City Board of Public
Utilities PTP Agreement to be effective 9/1/2018.
    Filed Date: 6/19/18.
    Accession Number: 20180619-5035.
    Comments Due: 5 p.m. ET 7/10/18.

    Docket Numbers: ER18-1795-000.
    Applicants: Southwestern Electric Power Company.
    Description: Sec.  205(d) Rate Filing: Hope PSA to be effective 5/
31/2018.
    Filed Date: 6/18/18.
    Accession Number: 20180618-5092.
    Comments Due: 5 p.m. ET 7/9/18.

    Docket Numbers: ER18-1796-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: First Revised ISA SA No.
4856; Queue No. AA2-121/AB2-104/AC1-003 to be effective 5/21/2018.
    Filed Date: 6/19/18.
    Accession Number: 20180619-5024.
    Comments Due: 5 p.m. ET 7/10/18.

    Docket Numbers: ER18-1797-000.
    Applicants: Ioway Energy, LLC.
    Description: Tariff Cancellation: Cancellation of Ioway Energy MBR
Tariff to be effective 6/19/2018.
    Filed Date: 6/19/18.
    Accession Number: 20180619-5048.
    Comments Due: 5 p.m. ET 7/10/18.

    Docket Numbers: ER18-1798-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: Original WMPA SA No. 5098;
Queue No. AB1-173/AB1-173A to be effective 5/21/2018.
    Filed Date: 6/19/18.
    Accession Number: 20180619-5062.
    Comments Due: 5 p.m. ET 7/10/18.

    Docket Numbers: ER18-1799-000.
    Applicants: Kentucky Utilities Company.
    Description: Sec.  205(d) Rate Filing: Amended Rate Schedules Nos.
185 and 157 TCJA to be effective 7/1/2018.
    Filed Date: 6/19/18.
    Accession Number: 20180619-5095.
    Comments Due: 5 p.m. ET 7/10/18.

    Docket Numbers: ER18-1800-000; ER18-1801-000; ER18-1802-000; ER18-
1803-000; ER18-1804-000; ER18-1805-000; ER18-1806-000; ER18-1807-000.
    Applicants: Bendwind, LLC, DeGreeff DP, LLC, DeGreeffpa, LLC, Groen
Wind, LLC, Hillcrest Wind, LLC, Larswind, LLC, Sierra Wind, LLC, TAIR
Windfarm, LLC.
    Description: Notice of Cancellation Market Base Rate Tariffs of
Bendwind, LLC, et al.
    Filed Date: 6/19/18.
    Accession Number: 20180619-5099.
    Comments Due: 5 p.m. ET 7/10/18.

    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 comment date. 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, nterventions, 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: June 19, 2018.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2018-13596 Filed 6-25-18; 8:45 am]
 BILLING CODE 6717-01-P