[Federal Register Volume 81, Number 128 (Tuesday, July 5, 2016)]
[Rules and Regulations]
[Pages 43490-43492]
[FR Doc No: 2016-15748]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R06-OAR-2016-0278 FRL-9948-60-Region 6]

Approval and Promulgation of Implementation Plans; Louisiana;
Baton Rouge Nonattainment Area; Base Year Emissions Inventory for the
2008 8-Hour Ozone Standard

AGENCY: Environmental Protection Agency (EPA).

ACTION: Direct final rule.

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SUMMARY: The Environmental Protection Agency (EPA) is proposing to
approve a revision to the State Implementation Plan (SIP) submitted by
the Louisiana Department of Environmental Quality (LDEQ) to address the
emissions inventory (EI) requirement for the Baton Rouge ozone
nonattainment area (BRNA) for the 2008 8-hour ozone National Ambient
Air Quality Standards (NAAQS). The Clean Air Act (CAA) requires an EI
for all ozone nonattainment areas. The inventory includes emission data
for Nitrogen Oxides (NOX) and Volatile Organic Compounds
(VOCs). EPA is approving the revisions pursuant to section 110 and part
D of the CAA and EPA's regulations.

DATES: This rule is effective on September 6, 2016 without further
notice, unless the EPA receives relevant adverse comment by August 4,
2016. If the EPA receives such comment, the EPA will publish a timely
withdrawal in the Federal Register informing the public that this rule
will not take effect.

ADDRESSES: Submit your comments, identified by Docket No. EPA-R06-OAR-
2016-0278, at http://www.regulations.gov or via email to
<EMAIL_ADDRESS>Follow the online instructions for submitting
comments. Once submitted, comments cannot be edited or removed from
Regulations.gov. The EPA may publish any comment received to its public
docket. Do not submit electronically any information you consider to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Multimedia submissions (audio,
video, etc.) must be accompanied by a written comment. The written
comment is considered the official comment and should include
discussion of all points you wish to make. The EPA will generally not
consider comments or comment contents located outside of the primary
submission (i.e. on the web, cloud, or other file sharing system). For
additional submission methods, please contact Ms. Nevine Salem, 214-
665-7222<EMAIL_ADDRESS>For the full EPA public comment policy,
information about CBI or multimedia submissions, and general guidance
on making effective comments, please visit http://www2.epa.gov/dockets/commenting-epa-dockets.
    Docket: The index to the docket for this action is available
electronically at www.regulations.gov and in hard copy at EPA Region 6,
1445 Ross Avenue, Suite 700, Dallas, Texas. While all documents in the
docket are listed in the index, some information may be publicly
available only at the hard copy location (e.g., copyrighted material),
and some may not be publicly available at either location (e.g., CBI).

FOR FURTHER INFORMATION CONTACT: Ms. Nevine Salem,<PHONE_NUMBER>,
<EMAIL_ADDRESS>To inspect the hard copy materials, please
schedule an appointment with Ms. Salem or Mr. Bill Deese at 214-665-
7253.

SUPPLEMENTARY INFORMATION: Throughout this document wherever ``we,''
``us,'' or ``our'' is used, we mean the EPA.

I. Background

A. The 2008 Ozone National Ambient Air Quality Standards (NAAQS) and
Emissions Inventory Requirements

    On March 12, 2008 EPA revised the eight-hour ozone NAAQS from 0.08
part per million (ppm) to 0.075 ppm. (73 FR 16436, March 27, 2008). In
2012, EPA designated nonattainment areas for the 2008 ozone NAAQS (2008
ozone nonattainment areas) (77 FR 30088, May 21, 2012).\1\ The Baton
Rouge area was designated as nonattainment areas for the 2008 ozone
NAAQS. The BRNA consists of five parishes: Ascension, East Baton Rouge,
Iberville, Livingston, and West Baton Rouge.
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    \1\ On October 1, 2015, the EPA strengthened the ozone standard
to 0.070 ppm (80 FR 65292, October 26, 2015). The EPA has not made
area designations under this new standard and the emissions
inventory under evaluation in this rulemaking does not address that
standard.
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    CAA sections 172(c)(3) and 182(a)(1), require states to develop and
submit, as a SIP revision, an EI for all areas designated as
nonattainment for the ozone NAAQS. An EI is an estimation of actual
emissions of air pollutants in an area. Ground-level ozone,
O3, is a gas that is formed by the reaction of volatile
organic compounds (VOCs) and oxides of nitrogen (NOX) in the
atmosphere in the presence of sunlight. (VOCs and NOX are
referred to as ozone precursors). Therefore, an EI for ozone covers the
emissions of VOC and NOX. These precursor emissions are
emitted by many types of pollution sources, including power plants and
industrial emissions sources, on-road and off-road motor vehicles and
engines, smaller stationary sources, collectively referred to as
nonpoint sources, and biogenic sources.\2\ The EI provides emissions
data for a variety of air quality planning tasks including establishing
baseline

emission levels, calculating federally required emission reduction
targets needed to attain the NAAQS, determining emission inputs for
ozone air quality simulation models, and tracking emissions over time
to determine progress toward achieving air quality and emission
reduction goals.
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    \2\ Biogenic emissions are produced by living organisms and are
typically not included in the base year emission inventories, but
are considered in ozone modeling analyses, which must consider all
emissions in a modeled area.
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    As stated above, the CAA requires the states to submit EIs for
areas designated as nonattainment for ozone. For the 2008 ozone NAAQS,
EPA has recommended that states use 2011 as a base year for the
emission estimates (78 FR 34178, 34190, June 6, 2013). However, EPA
also allows states to submit base year emissions for other years during
a recent ozone standard violation period. States are required to submit
estimates of VOC and NOX emissions for four general classes
of anthropogenic sources: stationary point sources; nonpoint sources;
on-road mobile sources; and off-road mobile sources in their EIs.

B. Louisiana's Submittal

    In a letter dated May 2, 2016, the LDEQ submitted the 2011 base
year inventory to the EPA as part of the BRNA designation and
maintenance plan. The EPA reviewed the 2011 base year inventory and
determined that it was developed in accordance with EPA guidelines.
Table 1 summarizes the 2011 VOC and NOX base year emission
for the BRNA area for a typical summer day (reflective of the summer
period, when the highest ozone concentrations are expected in these
ozone nonattainment areas).

    Table 1--Baton Rouge Nonattainment Area 2011 VOC and NOX Baseline
                           Emissions Inventory
                               [Tons/Day]
------------------------------------------------------------------------
                    Source type                        NOX        VOC
------------------------------------------------------------------------
Point.............................................       74.2       33.6
Nonpoint..........................................       17.1       82.6
Onroad Mobile.....................................       38.4       19.2
Nonroad Mobile....................................       27.3        8.7
------------------------------------------------------------------------
    Total.........................................      157.0      144.0
------------------------------------------------------------------------

C. CAA Requirements for the SIP Revision

    The primary CAA requirements pertaining to the SIP revision
submitted by LDEQ are found in CAA sections 110(l), 172(c)(3) and
182(a)(1). CAA section 110(l) requires that a SIP revision submitted to
EPA be adopted by the State after reasonable notice and public hearing.
Section 110(l) also prevents us from approving a SIP revision if the
revision would interfere with any applicable requirement concerning
attainment and reasonable further progress, or any other applicable
requirement of the CAA. CAA sections 172(c)(3) and 182(a) requires a
SIP revision that is a comprehensive, accurate, current inventory of
actual emissions from all sources.

II. EPA's Evaluation

    EPA has reviewed the revision for the consistency with the
requirements of EPA regulations. A summary of EPA's analysis is
provided below. For a full discussion of our evaluation, please see our
TSD.
    CAA sections 172 (c)(3) and 182(a)(1) require an inventory of
actual emissions from all sources of relevant pollutants in the
nonattainment areas. EPA specified in the 2008 ozone standard SIP
requirements rule that the states should use 2011 as a base year for EI
SIPs to address the EI requirements. LDEQ has developed a 2011 base
year emissions inventory for the Baton Rouge nonattainment areas. The
2011 base year emissions includes all point, nonpoint, non-road mobile,
and on-road mobile source emissions in BRNA. LDEQ utilized data from
the US EPA 2011 National Emissions Inventory (NEI), Version 2 as the
baseline emissions inventory to identify the level of emissions in the
area during the period of monitored attainment and satisfy the
requirement of section 182(a)(1).
    EPA reviewed the emission inventory and determined that it is
approvable because it was developed in accordance with EPA guidance on
emission inventory preparation. The inventory is a comprehensive,
accurate, and current inventory of actual emissions for all relevant
sources in accordance with CAA sections 172(c)(3) and 182(a)(1).
Additionally we found that (1) LDEQ adopted after reasonable notice and
public hearing and (2) approval would not interfere with any applicable
requirement concerning attainment and reasonable further progress or
any other applicable requirement of the CAA. A technical support
document (TSD) was prepared which details our evaluation. Our TSD may
be accessed online at www.regulations.gov, Docket No. EPA-R06-OAR-2016-
0278.

III. Final Action

    We are approving a Louisiana SIP revision submitted to address the
emissions inventory requirement for the Baton Rouge 2008 ozone NAAQS
nonattainment area. The inventory we are proposing to approve is listed
in table 1 above.
    We are publishing this rule without prior proposal because we view
this as a non-controversial amendment and anticipate no adverse
comments. However, in the proposed rules section of this Federal
Register publication, we are publishing a separate document that will
serve as the proposal to approve the SIP revision if relevant adverse
comments are received. This rule will be effective on September 6, 2016
without further notice unless we receive relevant adverse comment by
August 4, 2016. If we receive relevant adverse comments, we will
publish a timely withdrawal in the Federal Register informing the
public that the rule will not take effect. We will address all public
comments in a subsequent final rule based on the proposed rule. We will
not institute a second comment period on this action. Any parties
interested in commenting must do so now. Please note that if we receive
relevant adverse comment on an amendment, paragraph, or section of this
rule and if that provision may be severed from the remainder of the
rule, we may adopt as final those provisions of the rule that are not
the subject of an adverse comment.

IV. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the Act and applicable
Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. Accordingly, this
action merely proposes to approve state law as meeting Federal
requirements and does not impose additional requirements beyond those
imposed by state law. For that reason, this action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Order
12866 (58 FR 51735, October 4, 1993);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Public Law 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);

     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).

In addition, the SIP is not approved to apply on any Indian reservation
land or in any other area where EPA or an Indian tribe has demonstrated
that a tribe has jurisdiction. In those areas of Indian country, the
proposed rule does not have tribal implications as specified by
Executive Order 13175 (65 FR 67249, November 9, 2000), nor will it
impose substantial direct costs on tribal governments or preempt tribal
law.

    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. The 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 CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by September 6, 2016. 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, Incorporation by
reference, Nitrogen dioxide, Ozone, Reporting and recordkeeping
requirements, Volatile organic compounds.

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

    Dated: June 22, 2016.
Ron Curry,
Regional Administrator, Region 6.

    40 CFR part 52 is amended as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

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

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

Subpart T--Louisiana

0
2. In Sec.  52.970, the second table in paragraph (e) is amended by
adding the entry ``2011 Emissions Inventory for the 2008 Ozone NAAQS''
at the end of the table to read as follows:

Sec.  52.970  Identification of plan.

* * * * *
    (e) * * *

                 EPA Approved Louisiana Non-Regulatory Provisions and Quasi-Regulatory Measures
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                                       Applicable           State
      Name of SIP provision          geographic or     submittal  date/  EPA Approval date       Explanation
                                   nonattainment area  effective  date
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                                                  * * * * * * *
2011 Emissions Inventory for the  Baton Rouge Ozone            5/2/16   7/5/16 [Insert
 2008 Ozone NAAQS.                 Nonattainment Area.                   Federal Register
                                                                         citation].
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[FR Doc. 2016-15748 Filed 7-1-16; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 79, Number 6 (Thursday, January 9, 2014)]
[Rules and Regulations]
[Pages 1593-1596]
[FR Doc No: 2014-00030]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R04-OAR-2013-0440; FRL-9905-13-Region 4]

Approval and Promulgation of Implementation Plans; Tennessee;
Bristol; 2010 Lead Base Year Emissions Inventory and Conversion of
Conditional Approvals for Prevention of Significant Deterioration

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: The Environmental Protection Agency (EPA) is approving the
Lead 2010 base year emissions inventory State Implementation Plan (SIP)
revision submitted by the State of Tennessee, through the Tennessee
Department of Environment and Conservation (TDEC) on April 11, 2013.
The emissions inventory was submitted to meet the requirements of the
Clean Air Act (CAA or Act) for the Bristol 2008 Lead National Ambient
Air Quality Standards (NAAQS) nonattainment area (hereafter also
referred to as the ``Bristol Area'' or ``Area''). Additionally, EPA is
converting conditional approvals to full approvals for Tennessee's 1997
annual fine particulate matter (PM2.5) NAAQS, 2006 24-hour
PM2.5 NAAQS and 2008 8-hour ozone NAAQS infrastructure SIPs
as they relate to adequate provisions prohibiting emissions that
interfere with any other State's required measures to prevent
significant deterioration of its air quality. EPA conditionally
approved these portions of Tennessee's infrastructure SIPs for these
NAAQS on March 6, 2013, and March 26, 2013. Tennessee has since met the
obligations

associated with these conditional approvals, and therefore, EPA is
converting the conditional approvals to full approvals.

DATES: This rule will be effective February 10, 2014.

ADDRESSES: EPA has established a docket for this action under Docket
Identification No. EPA-R04-OAR-2013-0440. All documents in the docket
are listed on the www.regulations.gov Web site. Although listed in the
index, some information is not publicly available, i.e., Confidential
Business Information 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 www.regulations.gov or in hard
copy at the Regulatory Development Section, Air Planning Branch, Air,
Pesticides and Toxics Management Division, U.S. Environmental
Protection Agency, Region 4, 61 Forsyth Street SW., Atlanta, Georgia
30303-8960. EPA requests that if at all possible, you 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 federal
holidays.

FOR FURTHER INFORMATION CONTACT: Sean Lakeman, Regulatory Development
Section, Air Planning Branch, Air, Pesticides and Toxics Management
Division, U.S. Environmental Protection Agency, Region 4, 61 Forsyth
Street SW., Atlanta, Georgia 30303-8960. The telephone number is (404)
562-9043. Mr. Lakeman can be reached via electronic mail at
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:
I. Background
II. This Action
III. Final Action
IV. Statutory and Executive Order Reviews

I. Background

a. Emissions Inventory

    States are required under section 172(c)(3) of the CAA to develop
comprehensive, accurate and current emissions inventories of all
sources of the relevant pollutant or pollutants in the area. These
inventories provide a detailed accounting of all emissions and emission
sources by precursor or pollutant. In the November 12, 2008 Lead
Standard rulemaking, EPA finalized the guidance related to the
emissions inventories requirements. The current regulations are located
at 40 CFR 51.117(e), and include, but are not limited to, the following
requirements:
     States must develop and periodically update a
comprehensive, accurate, current inventory of actual emissions from all
source affecting ambient lead concentrations;
     The SIP inventory must be approved by EPA as a SIP element
and is subject to public hearing requirements; and
     The point source inventory upon which the summary of the
baseline for lead emissions inventory is based must contain all sources
that emit 0.5 or more tons of lead per year.
    For the base-year inventory of actual emissions, EPA recommends
using either 2010 or 2011 as the base year for the contingency measure
calculations, but does provide flexibility for using other inventory
years if states can show another year is more appropriate.\1\ For lead
SIPs, the CAA requires that all sources of lead emissions in the
nonattainment area must be submitted with the base-year inventory. In
today's action, EPA is approving the base year emissions inventory
portion of the SIP revision submitted by Tennessee on April 11, 2013,
as required by section 172(c)(3). On October 23, 2013, EPA proposed
approval of Tennessee's April 11, 2013, SIP revision. See 78 FR 63148.
EPA did not receive any comments, adverse or otherwise, on the October
23, 2013, proposed action.
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    \1\ See EPA document titled ``Addendum to the 2008 Lead NAAQS
Implementation Questions and Answers'' dated August 10, 2012,
included in EPA's SIP Toolkit located at http://www.epa.gov/air/lead/kitmodel.html.
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b. Conditional Approvals

    On October 4, 2012, Tennessee submitted a letter requesting
conditional approval of certain prevention of significant deterioration
(PSD)-related infrastructure elements.\2\ Specifically, Tennessee
requested conditional approval of elements of the infrastructure SIP
related to the requirements in its SIP applicable to its permitting
program for adopting the PM2.5 PSD increments as promulgated
in the rule entitled ``Prevention of Significant Deterioration (PSD)
for Particulate Matter Less Than 2.5 Micrometers (PM2.5)--
Increments, Significant Impact Levels (SILs) and Significant Monitoring
Concentration (SMC), Final Rule,'' 75 FR 64864 (October 20, 2010)
(hereafter referred to as the ``PM2.5 PSD Increments-SILs-
SMC Rule''). Following promulgation of the PM2.5 PSD
Increment-SILs-SMC Rule, the PSD increments portion of the Rule became
one of the prerequisites for approval of the PSD-related infrastructure
requirements of sections 110(a)(2)(C), 110(a)(2)(D)(i)(II) and
110(a)(2)(J) for the 1997 annual and 2006 24-hour PM2.5
NAAQS and the 2008 8-hour ozone NAAQS. The Rule provides additional
regulatory provisions under the PSD program regarding the
implementation of the PM2.5 NAAQS for New Source Review,
including PM2.5 increments pursuant to section 166(a) of the
CAA to prevent significant deterioration of air quality in areas
meeting the NAAQS. PSD increments prevent air quality in attainment/
unclassifiable areas from deteriorating to the level set by the NAAQS.
As such, an increment is the mechanism used to estimate ``significant
deterioration'' of air quality for a pollutant in an area. Under
section 165(a)(3) of the CAA, a PSD permit applicant must demonstrate
that emissions from the proposed construction and operation of a
facility ``will not cause, or contribute to, air pollution in excess of
any maximum allowable increase or allowable concentration for any
pollutant.''
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    \2\ The CAA requires that the SIP provide for the
implementation, maintenance, and enforcement of each NAAQS
promulgated by EPA, which is commonly referred to as an
``infrastructure'' SIP. See 42 U.S.C. 7410(a).
---------------------------------------------------------------------------

    With respect to the PSD-related requirements of section
110(a)(2)(D)(i)(II) for the 1997 annual and 2006 24-hour
PM2.5 NAAQS, and sections 110(a)(2)(C), 110(a)(2)(D)(i)(II)
and 110(a)(2)(J) for the 2008 8-hour ozone NAAQS, EPA conditionally
approved Tennessee's infrastructure SIP submissions, because at the
time of these approvals, the State had not yet adopted the PSD
increments provided in the PM2.5 PSD Increments-SILs-SMC
Rule; however, the State had committed through the October 4, 2012,
commitment letter to do so within one year. Based upon this commitment,
and consistent with section 110(k)(4) of the CAA, EPA took final action
to conditionally approval the portions of Tennessee's infrastructure
SIP submissions related to the above-described PSD program requirements
for the PM2.5 1997 annual and the 2006 24-hour NAAQS, and
the 2008 8-hour ozone NAAQS. See 78 FR 14450 (March 6, 2013) and 78 FR
18241 (March 26, 2013), respectively.
    Following these actions, and consistent with the terms of the
conditional approvals, Tennessee submitted a SIP revision on May 10,
2013, to adopt the PSD PM2.5 increments (set forth in
Chapter 1200-03-09 of the Tennessee Air Pollution Control Regulations--
Construction and Operating Permits, Rule Number .01--Construction
Permits) and the then

applicable regulatory requirements for implementing the
PM2.5 NAAQS, as promulgated in the PM2.5 PSD
Increments-SILs-SMC Rule. This SIP revision was provided to satisfy the
October 4, 2012, commitment made by the State. On July 25, 2013, EPA
took final action approving the May 10, 2013, submittal. See 78 FR
44886. As such, Tennessee has satisfied the conditions listed in EPA's
previous conditional approvals for these infrastructure submissions.
See 78 FR 44886 for additional information.

II. This Action

    On October 23, 2013 (78 FR 63148), EPA proposed approval of
Tennessee's April 11, 2013, submission regarding the Bristol, Tennessee
Lead 2010 base year emissions inventory and proposed to convert to full
approvals the existing conditional approvals of Tennessee's 1997 annual
PM2.5 NAAQS, 2006 24-hour PM2.5 NAAQS and 2008 8-
hour ozone NAAQS infrastructure SIPs as they relate to adequate
provisions prohibiting emissions that interfere with any other state's
required measures to prevent significant deterioration of its air
quality. EPA received no adverse comments on its proposed action and is
hereby finalizing approval of this action.

III. Final Action

    EPA is approving the 2010 base year emissions inventory SIP
revision for lead for the Bristol Area as submitted by the State of
Tennessee on April 11, 2013. Additionally, EPA is converting to full
approvals the March 6, 2013, and March 26, 2013, conditional approvals
of the PSD-related requirements of section 110(a)(2)(D)(i)(II) for the
1997 annual and the 2006 24-hour PM2.5 NAAQS, and the PSD-
related requirements of sections 110(a)(2)(C), 110(a)(2)(D)(i)(II) and
110(a)(2)(J) for the 2008 8-hour ozone. EPA is also removing the
conditional approval language from 40 CFR 52.2219 to reflect that these
elements of the infrastructure SIPs have been converted to full
approval, and that Tennessee has met the State's obligations related to
the previous conditional approvals. These actions are being taken
pursuant to section 110 of the CAA.

IV. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the Act and applicable
Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. Accordingly, this
action merely approves state law as meeting Federal requirements and
does not impose additional requirements beyond those imposed by state
law. For that reason, this action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Order
12866 (58 FR 51735, October 4, 1993);
     does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     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);
     does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).

In addition, this action does not have tribal implications as specified
by Executive Order 13175 (65 FR 67249, November 9, 2000), because the
SIP is not approved to apply in Indian country located in the State,
and EPA notes that it will not impose substantial direct costs on
tribal governments or preempt tribal law.
    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 action 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 CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by March 10, 2014. Filing a petition for
reconsideration by the Administrator of this final rule does not affect
the finality of this action 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, Incorporation by
reference, Intergovernmental relations, Nitrogen dioxide, Ozone,
Particulate matter, Reporting and recordkeeping requirements and Sulfur
oxides.

    Dated: December 23, 2013.
A. Stanley Meiburg,
Acting Regional Administrator, Region 4.

    40 CFR part 52 is amended as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

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

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

Subpart RR--Tennessee

0
2. Section 52.2219 is amended by removing and reserving paragraphs (c)
and (e) to read as follows:

Sec.  52.2219  Conditional approval.

* * * * *
    (c) [Reserved]
* * * * *
    (e) [Reserved]

0
3. Section 52.2220(e) is amended by adding a new entry for ``Bristol,
Tennessee Lead 2010 Base Year Emissions Inventory'' at the end of the
table to read as follows:

Sec.  52.2220  Identification of plan.

* * * * *
    (e) * * *

                                EPA-Approved Tennessee Non-Regulatory Provisions
----------------------------------------------------------------------------------------------------------------
                                       Applicable
   Name of non-regulatory SIP        geographic or      State effective    EPA-approval date      Explanation
            provision              nonattainment area         date
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
Bristol, Tennessee Lead 2010      Bristol............          4/11/2013  1/9/2014 [Insert    ..................
 Base Year Emissions Inventory.                                            citation of
                                                                           publication].
----------------------------------------------------------------------------------------------------------------

[FR Doc. 2014-00030 Filed 1-8-14; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 86, Number 175 (Tuesday, September 14, 2021)]
[Notices]
[Pages 51169-51170]
[FR Doc No: 2021-19755]

=======================================================================
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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

[Docket No. USCG-2021-0736]

Information Collection Request to Office of Management and
Budget; OMB Control Number: 1625-0029

AGENCY: Coast Guard, Homeland Security (DHS).

ACTION: Sixty-day notice requesting comments.

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

SUMMARY: In compliance with the Paperwork Reduction Act of 1995, the
U.S. Coast Guard intends to submit an Information Collection Request
(ICR) to the Office of Management and Budget (OMB), Office of
Information and Regulatory Affairs (OIRA), requesting approval of an
extension for the following collection of information: 1625-0029, Self-
propelled Liquefied Gas Vessels; without change. Our ICR describes the
information we seek to collect from the public. Before submitting this
ICR to OIRA, the Coast Guard is inviting comments as described below.

DATES: Comments must reach the Coast Guard on or before November 15,
2021.

ADDRESSES: You may submit comments identified by Coast Guard docket
number [USCG-2021-0736] to the Coast Guard using the Federal
eRulemaking Portal at https://www.regulations.gov. See the ``Public
participation and request for comments'' portion of the SUPPLEMENTARY
INFORMATION section for further instructions on submitting comments.
    A copy of the ICR is available through the docket on the internet
at https://www.regulations.gov. Additionally, copies are available
from: Commandant (CG-6P), Attn: Paperwork Reduction Act Manager, U.S.
Coast Guard, 2703 Martin Luther King Jr. Ave., SE, Stop 7710,
Washington, DC 20593-7710.

FOR FURTHER INFORMATION CONTACT: A.L. Craig, Office of Privacy
Management, telephone<PHONE_NUMBER>, or fax<PHONE_NUMBER>, for questions
on these documents.

SUPPLEMENTARY INFORMATION:

Public Participation and Request for Comments

    This notice relies on the authority of the Paperwork Reduction Act
of 1995; 44 U.S.C. chapter 35, as amended. An ICR is an application to
OIRA seeking the approval, extension, or renewal of a Coast Guard
collection of information (Collection). The ICR contains information
describing the Collection's purpose, the Collection's likely burden on
the affected public, an explanation of the necessity of the Collection,
and other important information describing the Collection. There is one
ICR for each Collection.
    The Coast Guard invites comments on whether this ICR should be
granted based on the Collection being necessary for the proper
performance of Departmental functions. In particular, the Coast Guard
would appreciate comments addressing: (1) The practical utility of the
Collection; (2) the accuracy of the estimated burden of the Collection;
(3) ways to enhance the quality, utility, and clarity of information
subject to the Collection; and (4) ways to minimize the burden of the
Collection on respondents, including the use of automated collection
techniques or other forms of information technology.
    In response to your comments, we may revise this ICR or decide not
to seek

an extension of approval for the Collection. We will consider all
comments and material received during the comment period.
    We encourage you to respond to this request by submitting comments
and related materials. Comments must contain the OMB Control Number of
the ICR and the docket number of this request, [USCG-2021-0736], and
must be received by November 15, 2021.

Submitting Comments

    We encourage you to submit comments through the Federal eRulemaking
Portal at https://www.regulations.gov. If your material cannot be
submitted using https://www.regulations.gov, contact the person in the
FOR FURTHER INFORMATION CONTACT section of this document for alternate
instructions. Documents mentioned in this notice, and all public
comments, are in our online docket at https://www.regulations.gov and
can be viewed by following that website's instructions. Additionally,
if you go to the online docket and sign up for email alerts, you will
be notified when comments are posted.
    We accept anonymous comments. All comments received will be posted
without change to https://www.regulations.gov and will include any
personal information you have provided. For more about privacy and
submissions in response to this document, see DHS's eRulemaking System
of Records notice (85 FR 14226, March 11, 2020).

Information Collection Request

    Title: Self-propelled Liquefied Gas Vessels.
    OMB Control Number: 1625-0029.
    Summary: The information is needed to ensure compliance with our
rules for the design and operation of liquefied gas carriers.
    Need: Title 46 U.S. Code sections 3703 and 9101 authorizes the
Coast Guard to establish regulations to protect life, property, and the
environment from the hazards associated with the carriage of dangerous
liquid cargo in bulk. Title 46 CFR part 154 prescribes the rules for
the carriage of liquefied gases in bulk on self-propelled vessels by
governing the design, construction, equipment, and operation of these
vessels and the safety of personnel aboard them.
    Forms: None.
    Respondents: Owners and operators of self-propelled vessels
carrying liquefied gas.
    Frequency: On occasion.
    Hour Burden Estimate: The estimated burden has increased from 8,169
hours to 14,781 hours a year, due to an increase in the estimated
number of respondents.
    Authority: The Paperwork Reduction Act of 1995; 44 U.S.C. chapter
35, as amended.

    Dated: September 8, 2021.
Kathleen Claffie,
Chief, Office of Privacy Management, U.S. Coast Guard.
[FR Doc. 2021-19755 Filed 9-13-21; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 75, Number 248 (Tuesday, December 28, 2010)]
[Notices]
[Page 81707]
[FR Doc No: 2010-32585]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Agency Information Collection Activities: Requests for Comments;
Clearance of Renewed Approval of Information Collection(s): Performance
and Handling Requirements for Rotorcraft

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice and request for comments.

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

SUMMARY: In accordance with the Paperwork Reduction Act of 1995, FAA
invites public comments about our intention to request the Office of
Management and Budget (OMB) approval to renew an information
collection. The Federal Register Notice with a 60-day comment period
soliciting comments on the following collection of information was
published on September 23, 2010, vol. 75, no. 184, page 58014. The FAA
requires that certain performance information be provided in the
Rotorcraft Flight Manual in order to show compliance to the regulatory
requirements. The flight manual, by regulation, must be furnished with
each aircraft.

DATES: Written comments should be submitted by January 27, 2011.

FOR FURTHER INFORMATION CONTACT: Carla Scott on<PHONE_NUMBER>, or by
e-mail at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:
    OMB Control Number: 2120-0726.
    Title: Performance and Handling Requirements for Rotorcraft.
    Form Numbers: There are no FAA forms associated with this
collection.
    Type of Review: Renewal of an information collection.
    Background: In order to determine that a rotorcraft is a safe
vehicle, an applicant for a type certificate must show compliance to
specific minimum requirements. In order to show compliance, an
applicant must substantiate the type design through analysis, testing,
design limitations, and other acceptable means. This substantiation
requires that certain performance information for safe operation of the
rotorcraft be presented, in the form of tables, diagrams, or charts, in
the flight manual. FAA engineers and designated engineers review the
required data submittals to determine that the rotorcraft complies with
the minimum safety requirements for rotorcraft performance and that the
rotorcraft has no unsafe features.
    Respondents: Approximately 4 normal or transport category
rotorcraft certification applicants.
    Frequency: Information is collected on occasion.
    Estimated Average Burden per Response: 5.5 hours.
    Estimated Total Annual Burden: 22 hours.

ADDRESSES: Interested persons are invited to submit written comments on
the proposed information collection to the Office of Information and
Regulatory Affairs, Office of Management and Budget. Comments should be
addressed to the attention of the Desk Officer, Department of
Transportation/FAA, and sent via electronic mail to<EMAIL_ADDRESS>or faxed to<PHONE_NUMBER>, or mailed to the
Office of Information and Regulatory Affairs, Office of Management and
Budget, Docket Library, Room 10102, 725 17th Street, NW., Washington,
DC 20503.
    Public Comments Invited: You are asked to comment on any aspect of
this information collection, including (a) Whether the proposed
collection of information is necessary for FAA's performance; (b) the
accuracy of the estimated burden; (c) ways for FAA to enhance the
quality, utility and clarity of the information collection; and (d)
ways that the burden could be minimized without reducing the quality of
the collected information. The agency will summarize and/or include
your comments in the request for OMB's clearance of this information
collection.

    Issued in Washington, DC on December 20, 2010.
Carla Scott,
FAA Information Collection Clearance Officer, IT Enterprises Business
Services Division, AES-200.
[FR Doc. 2010-32585 Filed 12-27-10; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 87, Number 200 (Tuesday, October 18, 2022)]
[Notices]
[Pages 63146-63147]
[FR Doc No: 2022-22537]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Receipt of Noise Compatibility Program Update and Request for
Review; Fort Lauderdale-Hollywood International Airport (FLL), Fort
Lauderdale, Florida

AGENCY: Federal Aviation Administration, DOT.

ACTION: Notice.

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

SUMMARY: The Federal Aviation Administration (FAA) announces that it is
reviewing a proposed Noise Compatibility Program (NCP) Update submitted
by Broward County, Florida, through its Aviation Department, for Fort
Lauderdale-Hollywood International Airport and has found it in
compliance with applicable requirements. This NCP Update was submitted
subsequent to a determination by the FAA that the associated Noise
Exposure Maps (NEMs) for the Fort Lauderdale-Hollywood International
Airport, were prepared in compliance with applicable requirements. The
NCP Update will be approved or disapproved (other than the proposed use
of flight procedures for noise control) on or before April 10, 2023.
Finally, this notice announces that the proposed NCP Update will be
available for public review and comment for 60 days from the
publication date of this notice.

DATES: The effective start date of the FAA's 180-day review period for
the associated NCP Update is October 12, 2022. The FAA must issue an
approval or disapproval of the NCP Update (other than the proposed use
of flight procedures for noise control) on or before April 10, 2023.
The public review and comment period ends 60 days from the publication
date of this notice.

FOR FURTHER INFORMATION CONTACT: Peter Green, Federal Aviation
Administration, Orlando Airports District Office, 8427 SouthPark
Circle, Suite 524, Orlando, Florida 32819,<PHONE_NUMBER>. Comments on
the proposed NCP Update should also be submitted to the above office.

SUPPLEMENTARY INFORMATION: This notice announces that the FAA is
reviewing a proposed NCP Update for the Fort Lauderdale-Hollywood
International Airport. As required by Title 14 Code of Federal
Regulations part 150 (hereinafter referred to as Part 150), the NCP
Update will be approved or disapproved (other than the proposed use of
flight procedures for noise control) on or before April 10, 2023.
Measures that involve changes to flight procedures require further
analysis and are not subject to the 180-day statutory decision
deadline. This notice also announces the availability of this NCP
Update for public review and comment for 60 days from the publication
date of this notice.
    Under the Aviation Safety and Noise Abatement Act (49 U.S.C. 47501
et seq.), an airport operator (hereinafter referred to as Sponsor) who
has submitted NEMs

that are found by the FAA to be in compliance with the requirements of
Part 150 may submit for FAA approval a NCP or NCP Update that sets
forth the measures the Sponsor has taken, or proposes to take, to
reduce existing non-compatible uses and prevent the introduction of
additional non-compatible uses within the area covered by the NEMs.
    The FAA has formally received the NCP Update for the Fort
Lauderdale-Hollywood International Airport, effective on October 12,
2022. Broward County, Florida, through its Aviation Department,
requested the FAA review this material and that the noise mitigation
measures, to be implemented jointly by the Sponsor and surrounding
communities, be approved as a NCP Update under the Act. Preliminary
review of the submitted material indicates that it conforms to Part 150
requirements for the submittal of an NCP, but that further review is
necessary prior to approval or disapproval of the NCP Update. The
formal review period, limited by law to a maximum of 180 days, will be
completed on or before April 10, 2023, with the exception of NCP
measures that propose the use of flight procedures for noise control. A
public hearing on the NCP was held by the Sponsor on April 21, 2021
    The FAA's detailed evaluation will be conducted under the
provisions of part 150, 105.33. The primary considerations in the
evaluation process are whether the proposed measures may reduce the
level of aviation safety or create an undue burden on interstate or
foreign commerce, and whether they are reasonably consistent with
obtaining the goal of reducing existing non-compatible land uses and
preventing the introduction of additional non-compatible land uses.
    Each airport NCP/NCP Update developed in accordance with part 150
is a local program, not a Federal program. The FAA does not substitute
its judgment for that of the Sponsor with respect to which measures
should be recommended for action. The FAA's approval or disapproval of
each specific measure proposed by a Sponsor in an NCP/NCP Update is
determined by applying approval criteria prescribed in Sec.  150.35(b)
of Part 150. Only measures that meet the approval criteria can be
approved and considered for Federal funding eligibility. FAA approval
or disapproval of a measure only indicates whether that measure would,
if implemented, be consistent with the purposes of Part 150. When a
measure is disapproved by the FAA, Sponsors are encouraged to work with
their communities and the FAA, outside of the part 150 process as
necessary, to implement initiatives that provide noise benefits for the
surrounding community.
    Interested persons are invited to comment on the proposed NCP
Update with specific reference to these factors. To maximize the
effectiveness of comments and the FAA's understanding of them, comments
should be as specific as possible, identifying the concern(s) as well
as suggested or desired resolution to the concern(s). When possible,
quote text and cite details such as page and section numbers, NCP
Update measure number, etc. to which the comment(s) pertain. This
commenting procedure is intended to ensure that substantive comments
and concerns are made available to the FAA in a timely manner so that
the FAA has an opportunity to address them in its Record of Approval.
All comments in their entirety become part of the public record,
including any personal information provided in the comment including
name, address, phone number, etc. All relevant comments, other than
those properly addressed to local land use authorities, will be
considered by the FAA to the extent practicable.
    Copies of the the proposed NCP Update are available for examination
online at www.fllpart150.com and by appointment at the following
location: Federal Aviation Administration, Orlando Airports District
Office, 8427 SouthPark Circle, Suite 524, Orlando, Florida 32819.
    Please direct questions or requests to arrange an appointment to
review the NCP Update document to the individual named above under the
heading, FOR FURTHER INFORMATION CONTACT.

    Issued in Orlando Airports District Office, Orlando, Florida on
October 12, 2022.
Rebecca Henry Harper,
Acting Manager, FAA/Orlando Airports District Office.
[FR Doc. 2022-22537 Filed 10-17-22; 8:45 am]
BILLING CODE P


[Federal Register: April 2, 2007 (Volume 72, Number 62)]
[Notices]
[Page 15674-15675]
[DOCID:fr02ap07-39]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[ Docket No. CP07-110-000]

Destin Pipeline Company, L.L.C.; Notice of Application

March 26, 2007.
    Take notice that on March 16, 2007, Destin Pipeline Company, L.L.C.
(Destin), 200 Westlake Park Boulevard, Houston, Texas 77079-2696, filed
in Docket No. CP07-110-000, an application pursuant to section 7(b) of
the Natural Gas Act (NGA) for an order authorizing Destin to abandon by
lease 260,000 Mcf/day of capacity (Lease Capacity) to Gulf South
Pipeline Company, L.P., with the option to increase the Lease Capacity
in excess of 260,000 Mcf/day, but not more than 700,000 Mcf/day, all as
more fully set forth in the application which is on file with the
Commission and open to public inspection. The instant filing

may be also viewed on the Web at http://www.ferc.gov using the

``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field to access the document. For
assistance, call<PHONE_NUMBER> or TTY,<PHONE_NUMBER>.
    Pursuant to Section 157.9 of the Commission's rules, 18 CFR 157.9,
within 90 days of this Notice the Commission staff will either:
complete its environmental assessment (EA) and place it into the
Commission's public record (eLibrary) for this proceeding; or issue a
Notice of Schedule for Environmental Review. If a Notice of Schedule
for Environmental Review is issued, it will indicate, among other
milestones, the anticipated date for the Commission staff's issuance of
the final environmental impact statement (FEIS) or EA for this
proposal. The filing of the EA in the Commission's public record for
this proceeding or the issuance of a Notice of Schedule for
Environmental Review will serve to notify federal and state agencies of
the timing for the completion of all necessary reviews, and the
subsequent need to complete all federal authorizations within 90 days
of the date of issuance of the Commission staff's FEIS or EA.
    Any questions regarding this application may be directed to Bruce
G. Reed, Director, Regulatory Affairs, BP Pipelines (North America),
200 Westlake Park Boulevard, Houston, Texas 77079-2696 or by telephone
at<PHONE_NUMBER> or telecopy to<PHONE_NUMBER>.
    There are two ways to become involved in the Commission's review of
this project. First, any person wishing to obtain legal status by
becoming a party to the proceedings for this project should, on or
before the below listed comment date, file with the Federal Energy
Regulatory Commission, 888 First Street, NE., Washington, DC 20426, a
motion to intervene in accordance with the requirements of the
Commission's Rules of Practice and Procedure (18 CFR 385.214 or
385.211) and the Regulations under the NGA (18 CFR 157.10). A person
obtaining party status will be placed on the service list maintained by
the Secretary of the Commission and will receive copies of all
documents filed by the applicant and by all other parties. A party must
submit 14 copies of filings made with the Commission and must mail a
copy to the applicant and to every other party in the proceeding. Only
parties to the proceeding can ask for court review of Commission orders
in the proceeding.
    However, a person does not have to intervene in order to have
comments considered. The second way to participate is by filing with
the Secretary of the Commission, as soon as possible, an original and
two copies of comments in support of or in opposition to this project.
The Commission will consider these comments in determining the
appropriate action to be taken, but the filing of a comment alone will
not serve to make the filer a party to the proceeding. The Commission's
rules require that persons filing comments in opposition to the project
provide copies of their protests only to the party or parties directly
involved in the protest.
    Persons who wish to comment only on the environmental review of
this project should submit an original and two copies of their comments
to the Secretary of the Commission. Environmental commenters will be
placed on the Commission's environmental mailing list, will receive
copies of the environmental documents, and will be notified of meetings
associated with the Commission's environmental review process.
Environmental commenters will not be required to serve copies of filed
documents on all other parties. However, the non-party commenters will
not receive copies of all documents filed by other parties or issued by
the Commission (except for the mailing of environmental documents
issued by the Commission) and will not have the right to seek court
review of the Commission's final order.
    Motions to intervene, protests and comments may be filed
electronically via the Internet in lieu of paper; see, 18 CFR
385.2001(a)(1)(iii) and the instructions on the Commission's Web site
under the ``e-Filing'' link. The Commission strongly encourages
electronic filings.
    Comment Date: April 16, 2007.

Philis J. Posey,
Acting Secretary.
 [FR Doc. E7-5940 Filed 3-30-07; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 80, Number 185 (Thursday, September 24, 2015)]
[Notices]
[Pages 57645-57649]
[FR Doc No: 2015-24216]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-75952; File No. SR-NYSEMKT-2015-64]

Self-Regulatory Organizations; NYSE MKT LLC; Notice of Filing and
Immediate Effectiveness of Proposed Rule Change To Make Permanent the
Rules of the New Market Model Pilot, the Supplemental Liquidity
Providers Pilot, and the Pilot Program Allowing ``UTP Securities'' To
Be Traded on the Exchange Pursuant to a Grant of Unlisted Trading
Privileges

September 18, 2015.
    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 September 9, 2015, NYSE MKT LLC (the ``Exchange'' or
``NYSE MKT'') filed with the Securities and Exchange Commission (the
``Commission'') the proposed rule change as described in Items I and II
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.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 15 U.S.C. 78a.
    \3\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to make permanent the rules of (1) the New
Market Model Pilot, (2) the Supplemental Liquidity Providers Pilot, and
(3) the pilot program allowing ``UTP Securities'' to be traded on the
Exchange pursuant to a grant of unlisted trading privileges (the ``UTP
Pilot''). The text of the proposed rule change is available on the
Exchange's Web site at www.nyse.com, at the principal office of the
Exchange, and at the Commission's Public Reference Room.

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

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

of the most significant parts of such statements.

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

1. Purpose
    The Exchange proposes to make permanent the rules of the (1) New
Market Model Pilot (``NMM Pilot''), (2) the Supplemental Liquidity
Providers Pilot (``SLP Pilot''), and (3) the UTP Pilot (collectively,
the ``Pilots''). The Pilots are currently scheduled to expire upon the
earlier of October 31, 2015 or Securities and Exchange Commission
(``SEC'' or ``Commission'') approval to make the Pilots permanent.\4\
---------------------------------------------------------------------------

    \4\ See Securities Exchange Act Nos. 75533 (July 28, 2015), 80
FR 46083 (August 3, 2015) (SR-NYSEMKT-2015-52); 75534 (July 28,
2015), 80 FR 46081 (August 3, 2015) (SR-NYSEMKT-2015-53); 75535
(July 28, 2015), 80 FR 46078 (August 3, 2015) (SR-NYSEMKT-2015-54).
---------------------------------------------------------------------------

Background
    In October 2008, the Exchange's affiliate the New York Stock
Exchange LLC (``NYSE'') implemented significant changes to its market
rules, execution technology and the rights and obligations of its
market participants referred to as the ``New Market Model'' which were
designed to improve execution quality on the NYSE.\5\ The Exchange
adopted the NMM Pilot pursuant to its merger with the NYSE.\6\
---------------------------------------------------------------------------

    \5\ See Securities Exchange Act Release No. 58845 (October 24,
2008), 73 FR 64379 (October 29, 2008) (SR-NYSE-2008-46) (``Release
No. 58845'').
    \6\ NYSE Euronext acquired The Amex Membership Corporation
(``AMC'') pursuant to an Agreement and Plan of Merger, dated January
17, 2008 (the ``Merger''). In connection with the Merger, the
Exchange's predecessor, the American Stock Exchange LLC (``Amex''),
a subsidiary of AMC, became a subsidiary of NYSE Euronext called
NYSE Alternext US LLC. See Securities Exchange Act Release No. 58673
(September 29, 2008), 73 FR 57707 (October 3, 2008) (SR-NYSE-2008-60
and SR-Amex-2008-62) (approving the Merger); see also Securities
Exchange Act Release Nos. 58705 (Oct. 1, 2008), 73 FR 58995 (Oct. 8,
2008) (SR-Amex-2008-63) (approving adoption of equities rules based
on those of NYSE) and 59022 (Nov. 26, 2008), 73 FR 73683 (Dec. 3,
2008) (SR-NYSEALTR-2008-10) (amending equity rules to conform to
NYSE NMM Pilot rules). Subsequently, NYSE Alternext US LLC was
renamed NYSE Amex LLC, which was then renamed NYSE MKT LLC and
continues to operate as a national securities exchange registered
under Section 6 of the Securities Exchange Act of 1934, as amended
(the ``Act''). See Securities Exchange Act Release Nos. 59575 (March
13, 2009), 74 FR 11803 (March 19, 2009) (SR-NYSEALTR-2009-24) and
67037 (May 21, 2012), 77 FR 31415 (May 25, 2012) (SR-NYSEAmex-2012-
32).
---------------------------------------------------------------------------

    The NYSE established the NMM Pilot to provide incentives for
quoting, to enhance competition among the existing group of liquidity
providers and to add a new competitive market participant. The Exchange
believes that the NMM Pilot allows the Exchange to provide its market
participants with a trading venue that utilizes an enhanced market
structure to encourage the addition of liquidity, facilitate the
trading of larger orders more efficiently and operates to reward
aggressive liquidity providers.
    As part of the NMM Pilot, the Exchange eliminated the function of
equity specialists on the Exchange and created a new category of market
participant, the Designated Market Maker or DMM.\7\ DMMs, like
specialists, have affirmative obligations to make an orderly market,
including continuous quoting requirements and obligations to re-enter
the market when reaching across to execute against trading interest.
Unlike specialists, DMMs have a minimum quoting requirement \8\ in
their assigned securities and no longer have a negative obligation.
DMMs are also no longer agents for public customer orders.\9\
---------------------------------------------------------------------------

    \7\ See NYSE MKT Rule 103--Equities.
    \8\ See NYSE MKT Rule 104--Equities.
    \9\ See NYSE MKT Rule 60--Equities; see also NYSE MKT Rules
104--Equities and 1000--Equities.
---------------------------------------------------------------------------

    In addition, the Exchange implemented a system change that allowed
DMMs to create a schedule of additional non-displayed liquidity at
various price points where the DMM is willing to interact with interest
and provide price improvement to orders in the Exchange's system. This
schedule is known as the DMM Capital Commitment Schedule (``CCS'').\10\
CCS provides the Display Book[supreg] with the amount of shares that
the DMM is willing to trade at price points outside, at and inside the
Exchange Best Bid or Best Offer (``BBO''). CCS interest is separate and
distinct from other DMM interest in that it serves as the interest of
last resort.
---------------------------------------------------------------------------

    \10\ See NYSE MKT Rule 1000--Equities.
---------------------------------------------------------------------------

    The Display Book[supreg] system is an order management and
execution facility that receives and displays orders to the DMMs,
contains the order information, and provides a mechanism to execute and
report transactions and publish the results to the Consolidated Tape.
The Display Book[supreg] system is connected to a number of other
Exchange systems for the purposes of comparison, surveillance, and
reporting information to customers and other market data and national
market systems. Because the Exchange has retired the actual system
referred to as the ``Display Book,'' but not the functionality
associated with the Display Book[supreg], the Exchange proposes to
replace all references to the term ``Display Book[supreg]'' in Rules
104 and 1000 with references either to the term (i) ``Exchange
systems'' when use of the term refers to the Exchange systems that
receive and execute orders, or (ii) ``Exchange book'' when use of the
term refers to the interest that has been entered and ranked in
Exchange systems.
    The NMM Pilot further modified the logic for allocating executed
shares among market participants having trading interest at a price
point upon execution of incoming orders. The modified logic rewards
displayed orders that establish the Exchange's BBO. During the
operation of the NMM Pilot, orders or portions thereof that establish
priority \11\ retain that priority until the portion of the order that
established priority is exhausted. Where no one order has established
priority, shares are distributed among all market participants on
parity.
---------------------------------------------------------------------------

    \11\ See NYSE MKT Rule 72(a)(ii)--Equities.
---------------------------------------------------------------------------

    The NYSE SLP Pilot was launched in coordination with the NMM Pilot,
which established SLPs as a new class of market participants to
supplement the liquidity provided by DMMs.\12\ The NYSE established the
SLP Pilot to provide incentives for quoting, to enhance competition
among the existing group of liquidity providers, including the DMMs,
and add new competitive market participants. NYSE MKT Rule 107B--
Equities is based on NYSE Rule 107B. NYSE MKT Rule 107B--Equities was
filed with the Commission on December 30, 2009, as a ``me too'' filing
for immediate effectiveness as a pilot program.\13\
---------------------------------------------------------------------------

    \12\ See NYSE Rule 107B and NYSE MKT Rule 107B--Equities. The
NYSE amended the monthly volume requirements to an average daily
volume (``ADV'') that is a specified percentage of NYSE consolidated
ADV. See Securities Exchange Act Release No. 67759 (August 30,
2012), 77 FR 54939 (September 6, 2012) (SR-NYSE-2012-38).
    \13\ See Securities Exchange Act Release No. 61308 (January 7,
2010), 75 FR 2573 (January 15, 2010) (SR-NYSEAmex-2009-98)
(``Release No. 61308'').
---------------------------------------------------------------------------

    Similarly, in 2010, the Exchange adopted NYSE MKT Rules 500-525--
Equities as a pilot program governing the trading of any ``UTP
Securities'' on the Exchange pursuant to unlisted trading
privileges.\14\ The UTP Pilot was also based on the NMM Pilot trading

rules used by the Exchange and the NYSE for listed equity
securities.\15\
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    \14\ See Securities Exchange Act Release No. 62479 (July 9,
2010), 75 FR 41264 (July 15, 2010) (SR-NYSEAmex-2010-31) (``UTP
Pilot Approval Order''). ``UTP Securities'' is included within the
definition of ``security'' as that term is used in the NYSE MKT
Equities Rules. See NYSE MKT Rule 3--Equities. In accordance with
this definition, UTP Securities are admitted to dealings on the
Exchange on an ``issued,'' ``when issued,'' or ``when distributed''
basis. See NYSE MKT Rule 501--Equities.
    \15\ See Securities Exchange Act Release No. 61890 (April 12,
2010), 75 FR 20401, 20402, n. 7 (April 19, 2010) (SR-NYSEAmex-2010-
31) (noting that because several elements of the Exchange's proposal
to trade Nasdaq Securities rely on the NYSE's NMM pilot, the
Exchange proposed to extend the duration of the UTP Pilot as needed
to track the NYSE's NMM Pilot program and would file for permanent
approval at the same time or after the NYSE files for permanent
approval of the NMM).
---------------------------------------------------------------------------

    The UTP Pilot includes any security, other than a security that is
listed on the Exchange, that (i) is designated as an ``eligible
security'' pursuant to the ``UTP Plan,'' \16\ (ii) has been admitted to
dealings on the Exchange pursuant to a grant of unlisted trading
privileges in accordance with Section 12(f) of the Act,\17\ and (iii)
if it is an ``Exchange Traded Product'' (``ETP'') that does not have
any component security that is listed or traded on the Exchange or the
NYSE; provided, however, that the Invesco PowerShares QQQTM
(the ``QQQ'' TM) may be admitted to dealings on the Exchange
pursuant to a grant of unlisted trading privileges although one or more
component securities of the QQQ may be listed or traded on the Exchange
or the NYSE, subject to the conditions of Rule 504(b)(5)--Equities.
---------------------------------------------------------------------------

    \16\ With respect to Nasdaq Securities, the term ``UTP Plan''
means the Joint Self-Regulatory Organization Plan Governing the
Collection, Consolidation and Dissemination of Quotation and
Transaction Information for Nasdaq-listed Securities Traded on
Exchanges on an Unlisted Trading Privilege Basis, as amended from
time to time, filed with and approved by the Commission. See
Securities Exchange Act Release No. 70953 (November 27, 2013), 78 FR
72932 (December 4, 2013) (File No. S7-24-89). The Exchange's
predecessor, the American Stock Exchange LLC, joined the UTP Plan in
2001. See Securities Exchange Act Release No. 55647 (April 19,
2007), 72 FR 20891 (April 26, 2007) (File No. S7-24-89). In March
2009, the Exchange changed its name to NYSE Amex LLC, and, in May
2012, the Exchange subsequently changed its name to NYSE MKT LLC.
See Securities Exchange Act Release Nos. 59575 (March 13, 2009), 74
FR 11803 (March 19, 2009) (SR-NYSEALTR-2009-24) and 67037 (May 21,
2012), 77 FR 31415 (May 25, 2012) (SR-NYSEAmex-2012-32). With
respect to all other UTP Securities, the term ``UTP Plan'' means the
Consolidated Tape Association Plan for the Dissemination of Last
Sale Prices of Transactions in Eligible Securities, as amended from
time to time, filed with and approved by the Commission. See
Securities Exchange Act Release No. 10787 (May 10, 1974), 39 FR
17799 (May 20, 1974) (declaring the CTA Plan effective). See also
Securities Exchange Release No. 70794 (October 31, 2013), 78 FR
66789 (November 6, 2013) (SR-CTA-2013-05).
    \17\ 15 U.S.C. 78l.
---------------------------------------------------------------------------

    The NMM Pilot was originally scheduled to end on October 1,
2009,\18\ while the SLP Pilot was originally scheduled to be a six-
month pilot program.\19\ The UTP Pilot was originally scheduled to
continue until September 30, 2010.\20\ The Exchange filed to extend the
operation of the Pilots on several occasions in order to prepare a rule
filing seeking permission to make the above described changes
permanent, most recently in July 2015.\21\
---------------------------------------------------------------------------

    \18\ See Release No. 58845, 73 FR at 6904.
    \19\ See Release No. 61308, 75 FR at 2573.
    \20\ See UTP Pilot Approval Order, 75 FR at 41265.
    \21\ See note 4, supra.
---------------------------------------------------------------------------

Proposal To Make the Pilots Permanent
    The NYSE adopted the NMM Pilot in part to adapt the NYSE's model to
the equities market environment in place in 2008. The Exchange adopted
the NMM Pilot in its entirety as part of its merger with the NYSE.
Similarly, the Exchange adopted the SLP Pilot to encourage an
additional pool of liquidity at the Exchange following the approval of
the NMM Pilot. On July 31, 2015, the Commission approved making the
rules associated with the NMM Pilot and SLP Pilot permanent on the NYSE
(the ``NMM/SLP Approval Order'').\22\
---------------------------------------------------------------------------

    \22\ See Securities Exchange Act Release No. 75578 (July 31,
2015), 80 FR 47008 (August 6, 2015) (SR-NYSE-2015-26).
---------------------------------------------------------------------------

    In its order, the SEC determined that each of the following key
provisions of the NYSE NMM Pilot were consistent with the Act: (1) The
changes to NYSE's priority and order allocation structure under NYSE
Rule 72; \23\ (2) the dealings and responsibilities of DMMs, including
the affirmative obligation to market quality, the quoting obligation,
the re-entry requirements following certain transactions for a DMM's
own account, and, implicitly, the elimination of the ``negative
obligation'' set forth in NYSE Rule 104; \24\ and (3) the provisions
related to DMM CCS interest set forth in NYSE Rule 1000.\25\ In
addition, the Commission determined that the NYSE SLP Pilot, as part of
the NYSE NMM Pilot, produced sufficient execution quality to attract
volume and sufficient incentives to liquidity providers to supply this
execution quality.\26\
---------------------------------------------------------------------------

    \23\ See id., 80 FR at 47013.
    \24\ See id.
    \25\ See id. In particular, the SEC concluded that the NYSE had
shown that the NMM Pilot, which includes the parity provisions under
NYSE Rule 72, produced sufficient execution quality to attract
volume and sufficient incentives to liquidity providers to supply
this execution quality. Similarly, the Commission concluded that the
NYSE had shown that the NMM Pilot, which includes the DMM dealings
and responsibilities provisions and the CCS interest provisions of
NYSE Rules 104 and 1000, respectively, produced sufficient execution
quality to attract volume and sufficient incentives to liquidity
providers to supply this execution quality. See id.
    \26\ See id., 80 FR at 47014.
---------------------------------------------------------------------------

    The Exchange has operated the NMM Pilot and SLP Pilot using the
same rules, the same trading systems, and operating in the same manner
as the NYSE. The Exchange accordingly believes that the Commission's
findings in the NMM/SLP Approval Order, and in particular that the NYSE
pilots operated as intended and are consistent with the Act, apply
equally to the operation of the Pilots on the Exchange. Similarly, the
UTP Pilot has been operating on the Exchange for the past five years
based on the NMM Pilot trading rules the Commission recently approved
for NYSE. Moreover, in approving the UTP Pilot, the Commission
acknowledged that the rules relating to DMM benefits and duties in
trading Nasdaq Securities on the Exchange pursuant to the UTP Pilot are
consistent with the Act \27\ and noted the similarity to the NMM Pilot,
particularly with respect to DMM obligations and benefits.\28\ Further,
the UTP Pilot rules pertaining to the assignment of securities to DMMs
are also substantially similar to the rules implemented through the
recently approved NMM Pilot.\29\ The Exchange notes that making the UTP
Pilot permanent would provide for the uninterrupted trading of UTP
Securities on the Exchange on an unlisted trading privileges basis and
thus continue to encourage the additional utilization of, and
interaction with, the Exchange, and provide market participants with
improved price discovery, increased liquidity, more competitive quotes
and greater price improvement for UTP Securities.
---------------------------------------------------------------------------

    \27\ See UTP Pilot Approval Order, 75 FR at 41270. The Exchange
considers the same to be true with respect to all UTP Securities in
the UTP Pilot, including for ETPs.
    \28\ See UTP Pilot Approval Order, 75 FR at 41271.
    \29\ Id.
---------------------------------------------------------------------------

    For the foregoing reasons, the Exchange believes that making the
Pilots' rules, as amended, permanent on the Exchange is appropriate.
    The Exchange also proposes to delete Rule 104T--Equities (Dealings
by DMMs), which is the pre-NMM Pilot version of Rule 104--Equities.
Rule 104T--Equities remains in the Exchange's rule book, but is not
operational. With permanent approval of current Rule 104--Equities, the
need to retain Rule 104T--Equities is mooted. The Exchange also
proposes to delete Supplementary Material .05 to Rule 104--Equities,
and related reference to that Supplementary Material in Rule
104(a)(2)--Equities, because that rule text was intended to be in
effect only through October 31, 2009.\30\
---------------------------------------------------------------------------

    \30\ See Securities Exchange Act Release No. 60574 (Aug. 26,
2009), 74 FR 45506 (Sept. 2, 2009) (SR-NYSEAmex-2009-58) (Notice of
Filing).
---------------------------------------------------------------------------

    Finally, the Exchange proposes to replace the reference to ``NYSE
Regulation's Division of Market Surveillance'' in Rule 104(k)--Equities

with a reference to the Exchange. Pursuant to Rule 0(c), references to
the Exchange may mean references to NYSE Regulation or FINRA, which
performs certain regulatory services to the Exchange pursuant to a
Regulatory Services Agreement.
    The Exchange notes that the proposed change is 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 rule change.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with Section 6(b) of the Act,\31\ in general, and furthers the
objectives of Section 6(b)(5) of the Act,\32\ in particular, because it
is designed to prevent fraudulent and manipulative acts and practices,
to promote just and equitable principles of trade, to foster
cooperation and coordination with persons engaged in regulating,
clearing, settling, processing information with respect to, and
facilitating transactions in securities, to remove impediments to, and
perfect the mechanisms of, a free and open market and a national market
system and, in general, to protect investors and the public interest
and because it is not designed to permit unfair discrimination between
customers, issuers, brokers, or dealers.
---------------------------------------------------------------------------

    \31\ 15 U.S.C. 78f(b).
    \32\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    The Exchange believes the proposed rule change is consistent with
these principles because it seeks to make permanent Pilots and
associated rule changes that were previously approved as permanent by
the Commission based on findings that the NYSE NMM Pilot and NYSE SLP
Pilot have operated as intended on the Exchange's affiliate and are
consistent with the Act. Similarly, in the case of the UTP Pilot, the
Exchange seeks to make permanent a pilot and associated rule changes
that is based on trading rules adopted as part of the recently approved
NYSE NMM Pilot.
    The Exchange also believes the proposed rule change is designed to
facilitate transactions in securities and to remove impediments to, and
perfect the mechanisms of, a free and open market and a national market
system because making the Pilots permanent would provide market
participants with a trading venue that encourages the addition of
liquidity, facilitates the trading of larger orders more efficiently,
operates to reward aggressive liquidity providers. The Exchange
believes that making the Pilots permanent would encourage the
additional utilization of, and interaction with, the Exchange and
provide customers with the premier venue for price discovery,
liquidity, competitive quotes, and price improvement.
    In addition, the Exchange believes that making the Pilots permanent
would promote just and equitable principles of trade and remove
impediments to and perfect the mechanism of a free and open market
because, as the Commission found in approving the NMM Pilot and SLP
Pilot for the NYSE, the rules strike the appropriate balance between
the obligations and benefits of the Exchange's market participants.
    Finally, the Exchange believes that it is subject to significant
competitive forces, as described below in the Exchange's statement
regarding the burden on competition. For these reasons, the Exchange
believes that the proposal is consistent with the Act.

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

    In accordance with Section 6(b)(8) of the Act,\33\ 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. The Exchange believes that making the Pilots
permanent would continue to foster competition among liquidity
providers and maintain execution quality on the Exchange. The Exchange
notes that it operates in a highly competitive market in which market
participants can easily direct their orders to competing venues,
including off-exchange venues. In such an environment, the Exchange
must continually review, and consider adjusting the services it offers
and the requirements it imposes to remain competitive with other U.S.
equity exchanges. For the reasons described above, the Exchange
believes that the proposed rule change reflects this competitive
environment.
---------------------------------------------------------------------------

    \33\ 15 U.S.C. 78f(b)(8).
---------------------------------------------------------------------------

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

    Because the proposed rule change does not (i) significantly affect
the protection of investors or the public interest; (ii) impose any
significant burden on competition; and (iii) become operative for 30
days from the date on which it was filed, or such shorter time as the
Commission may designate, the proposed rule change has become effective
pursuant to Section 19(b)(3)(A) of the Act \34\ and Rule 19b-4(f)(6)
thereunder.\35\
---------------------------------------------------------------------------

    \34\ 15 U.S.C. 78s(b)(3)(A).
    \35\ 17 CFR 240.19b-4(f)(6). As required under Rule 19b-
4(f)(6)(iii), the Exchange provided the Commission with written
notice of its intent to file the proposed rule change, along with a
brief description and the text of the proposed rule change, at least
five business days prior to the date of filing of the proposed rule
change, or such shorter time as designated by the Commission.
---------------------------------------------------------------------------

    A proposed rule change filed pursuant to Rule 19b-4(f)(6) under the
Act \36\ normally does not become operative for 30 days after the date
of its filing. However, Rule 19b-4(f)(6)(iii) \37\ permits the
Commission to designate a shorter time if such action is consistent
with the protection of investors and the public interest. The Exchange
has asked the Commission to waive the 30-day operative delay so that
the proposal may become operative immediately upon filing, noting that
the proposed rule change is based on the approved rules of the NYSE,
which are already operative, and that making the Pilots permanent would
not alter trading on the Exchange. The Commission believes the waiver
of the operative delay is consistent with the protection of investors
and the public interest. Therefore, the Commission hereby waives the
operative delay and designates the proposal operative upon filing.\38\
---------------------------------------------------------------------------

    \36\ 17 CFR 240.19b-4(f)(6).
    \37\ 17 CFR 240.19b-4(f)(6)(iii).
    \38\ For purposes only of waiving the 30-day operative delay,
the Commission has also considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
---------------------------------------------------------------------------

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

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act.

Comments may be submitted by any of the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-NYSEMKT-2015-64 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NYSEMKT-2015-64. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549, on official business days between the hours of 10
a.m. and 3 p.m. Copies of the filing will also be available for
inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-NYSEMKT-2015-64 and should
be submitted on or before October 15, 2015.
    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\39\
---------------------------------------------------------------------------

    \39\ 17 CFR 200.30-3(a)(12).

Brent J. Fields,
Secretary.
[FR Doc. 2015-24216 Filed 9-23-15; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 84, Number 24 (Tuesday, February 5, 2019)]
[Notices]
[Pages 1746-1747]
[FR Doc No: 2019-01131]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-1987-D-0240 (formerly 87D-0315)]

Neomycin Sulfate for Prescription Compounding; Withdrawal of
Approval of One Abbreviated New Drug Application

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is
withdrawing approval of abbreviated new drug application (ANDA) 061579
for nonsterile neomycin sulfate powder for prescription compounding.
The basis for the withdrawal is that the product is no longer
considered safe as labeled due to clinical evidence that systemic
exposure to neomycin sulfate can induce significant toxicity, including
ototoxicity (manifested as sensorineural hearing loss), nephrotoxicity,
and neuromuscular blockade. The holder of this ANDA has waived its
opportunity for a hearing.

DATES: Approval is withdrawn as of February 5, 2019.

FOR FURTHER INFORMATION CONTACT: Kate Greenwood, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6286, Silver Spring, MD 20993-0002, 240-
402-1748.

SUPPLEMENTARY INFORMATION: In the Federal Register of April 15, 1988,
FDA published four documents arising out of the Agency's finding that
systemic absorption of neomycin sulfate can induce significant
toxicity, including ototoxicity (manifested as sensorineural hearing
loss), nephrotoxicity, and neuromuscular blockade (see generally 53 FR
12644; 53 FR 12658; 53 FR 12662; and 53 FR 12664 (April 15, 1988)). Two
of the four documents were issued under docket numbers FDA-1979-N-0220
and FDA-1987-D-0240 and related to nonsterile neomycin sulfate for
prescription compounding.\1\
---------------------------------------------------------------------------

    \1\ These documents were originally assigned docket numbers 79N-
0155, and 87D-0315. The numbers were changed to FDA-1979-N-0220 and
FDA-1987-D-0240, respectively, as a result of FDA's transition to
its new docketing system (Regulations.gov) in January 2008. The
other two documents were issued under docket number FDA-1979-N-0256
(formerly 79N-0151) and related to neomycin sulfate in sterile vials
for parenteral use.
---------------------------------------------------------------------------

    Under docket number FDA-1979-N-0220, FDA published a final rule
amending the antibiotic drug

regulations governing the certification of nonsterile neomycin sulfate
powder for prescription compounding (53 FR 12644). Based on its
evaluation of the written and oral comments received on the proposed
rule (44 FR 44180 (July 27, 1979)), and based on other information, FDA
concluded that there was a favorable risk:benefit profile for orally
administered neomycin sulfate preparations as adjunctive therapy for
preoperative suppression of intestinal bacteria and for the treatment
of hepatic coma. However, consistent with the findings published in the
proposed rule, FDA concluded in the final rule that the risks of
adverse reactions from the use of the product for wound irrigation
resulted in systemic absorption and a resultant risk of adverse
reactions that significantly outweighed any demonstrated benefits.
Accordingly, the final rule amended the antibiotic drug regulations by
changing the product name from ``neomycin sulfate for prescription
compounding'' to ``neomycin sulfate for compounding oral products'' and
by requiring package insert labeling to provide information concerning
the appropriate uses of the product and to warn about the risks
associated with inappropriate use.
    Under docket number FDA-1987-D-0240, FDA proposed to issue an order
under section 505(e) of the Federal Food, Drug, and Cosmetic Act (FD&C
Act) (21 U.S.C. 355(e)) withdrawing approval of six antibiotic drug
applications and abbreviated antibiotic drug applications (AADAs) \2\
for nonsterile neomycin sulfate for prescription compounding products
unless the application holders submitted supplemental applications
providing for a product name and labeling consistent with the revised
name and labeling requirements described in the newly amended
antibiotic certification regulations (53 FR 12662).\3\ In the document,
FDA announced the availability of guideline labeling for nonsterile
neomycin sulfate for prescription compounding products that
manufacturers could adopt to ensure that their labeling would be
consistent with the labeling required by the revised antibiotic
certification regulations. The proposed order was based on clinical or
other experience, tests, or other scientific data that showed
nonsterile neomycin sulfate was unsafe for use except when named
``Neomycin Sulfate for Compounding Oral Products'' and used in
accordance with package insert labeling that provides information
concerning appropriate uses and that warns about risks associated with
inappropriate use. Under section 505 and the regulations promulgated at
21 CFR parts 310 and 314, the holders of the applications were given
the opportunity for a hearing to show why approval should not be
withdrawn. One application holder, Pharma-Tek, Inc. (Pharma-Tek),
requested a hearing to challenge FDA's proposal to withdraw approval of
its application, AADA 61-579. On December 6, 1988, FDA announced the
withdrawal of approval of five of the six applications for nonsterile
neomycin sulfate for prescription compounding for which the holders had
not requested a hearing (53 FR 49231). The AADA for neomycin sulfate
for prescription compounding, AADA 61-579, held by Pharma-Tek, was not
withdrawn at that time because of the sponsor's pending hearing
request. Today, this application corresponds to ANDA 061579 held by X-
Gen Pharmaceuticals, Inc. (X-Gen).
---------------------------------------------------------------------------

    \2\ The terms ``antibiotic drug applications'' and ``abbreviated
antibiotic drug applications'' are no longer used. AADAs approved
under section 507 of the FD&C Act on or before November 20, 1997,
are deemed to have been approved under section 505(j) of the FD&C
Act.
    \3\ This proposed regulatory action was necessary because the
antibiotic drug certification regulations did not apply to products
with applications in which FDA had approved alternative labeling.
---------------------------------------------------------------------------

    X-Gen informed FDA by letter dated October 9, 2015, that it was
withdrawing the hearing request previously filed on behalf of its
predecessor Pharma-Tek concerning ANDA 061579. X-Gen also informed FDA
that it waived the opportunity for a hearing and, under 21 CFR
314.150(d), X-Gen permitted the Agency to withdraw approval of ANDA
061579 for neomycin sulfate for prescription compounding.
    For the reasons discussed in the document published in the Federal
Register on April 15, 1988, under docket number FDA-1987-D-0240, the
Director of FDA's Center for Drug Evaluation and Research finds that
ANDA 061579 was withdrawn from sale for safety and effectiveness
reasons (21 CFR 314.161(c)). The Director, under section 505(e) of the
FD&C Act and under authority delegated to her by the Commissioner, also
finds that new evidence of clinical experience, not contained in ANDA
061579 and not available at the time the application was approved,
evaluated together with the evidence available to the Secretary when
the application was approved, shows that nonsterile neomycin sulfate
for prescription compounding is not shown to be safe for use under the
conditions of use upon the basis of which the application was approved
(21 U.S.C. 355(e)). Therefore, approval of ANDA 061579 is hereby
withdrawn.
    Under 21 CFR 314.161(e) and 314.162(a)(2), FDA will remove ANDA
061579 from the list of drug products with effective approvals
published in FDA's ``Approved Drug Products With Therapeutic
Equivalence Evaluations.''

    Dated: January 23, 2019.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2019-01131 Filed 2-4-19; 8:45 am]
 BILLING CODE 4164-01-P