[Federal Register Volume 76, Number 205 (Monday, October 24, 2011)]
[Notices]
[Pages 65765-65767]
[FR Doc No: 2011-27379]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-65587; File No. SR-NASDAQ-2011-144]

Self-Regulatory Organizations; The NASDAQ Stock Market LLC;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change
Relating to the Establishment of a Direct Market Data Product, NASDAQ
Options Trade Outline (``NOTO'')

October 18, 2011.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on October 12, 2011, The NASDAQ Stock Market LLC (``NASDAQ'' or
``Exchange'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I, II,
and III below, which Items have been prepared by the Exchange. The
Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of the
Substance of the Proposed Rule Change

    The Exchange proposes to establish a direct market data product,
NASDAQ Options Trade Outline (``NOTO'').
    The text of the proposed rule change is available on the Exchange's
Web site at http://www.nasdaq.cchwallstreet.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 Exchange included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The Exchange has prepared summaries, set forth in
sections A, B, and C below, of the most significant aspects of such
statements.

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

1. Purpose
    The purpose of the proposed rule change is to establish the NOTO
market data product. NOTO is a market data product offered by the
Exchange that is designed to provide proprietary electronic trade data
to subscribers. NOTO is available as either an ``End-of-Day'' data
product or an ``Intra-Day'' data product, as described more fully
below. NOTO is available to any person who wishes to subscribe to it,
regardless of whether or not they are a member of the Exchange. NOTO is
available only for internal use and distribution by subscribers.
Data Included in NOTO
    NOTO provides information about the activity of a particular option
series during a particular trading session. NOTO subscribers will
receive the following data:
     Aggregate number of buy and sell transactions in the
affected series;
     Aggregate volume traded electronically on the Exchange in
the affected series;
     Aggregate number of trades effected on the Exchange to
open a position; \3\
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    \3\ NOTO will provide subscribers with the aggregate number of
``opening purchase transactions'' in the affected series. An opening
purchase transaction is an Exchange options transaction in which the
purchaser's intention is to create or increase a long position in
the series of options involved in such transaction. NOTO will also
provide subscribers with the aggregate number of ``opening writing
transactions.'' An opening writing transaction is an Exchange
options transaction in which the seller's (writer's) intention is to
create or increase a short position in the series of options
involved in such transaction.
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     Aggregate number of trades effected on the Exchange to
close a position; \4\
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    \4\ NOTO will provide subscribers with the aggregate number of
``closing purchase transactions'' in the affected series. A closing
purchase transaction is an Exchange options transaction in which the
purchaser's intention is to reduce or eliminate a short position in
the series of options involved in such transaction. NOTO will also
provide subscribers with the aggregate number of ``closing sale
transactions.'' A closing sale transaction is an Exchange options
transaction an Exchange options transaction in which the seller's
intention is to reduce or eliminate a long position in the series of
options involved in such transaction.

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     Origin of the orders involved in trades on the Exchange in
the affected series during a particular trading session, specifically
aggregated in the following categories of participants: customers,
broker-dealers, and market makers.
End of Day Product
    The End of Day product includes the aggregate data described above
representing the entire trading session. It is calculated during an
overnight process after each trading session and is available to
subscribers for download the following morning at approximately 7 a.m.,
E.T.
    The Exchange will establish a monthly subscriber fee for the End of
Day product by way of a separate proposed rule change, which the
Exchange will submit after the NOTO market data product is established.
Intra-Day Product
    The Intra-Day product includes periodic, cumulative data for a
particular trading session. The Intra-Day product is produced and
updated every ten minutes during the trading day. Data is captured in
``snapshots'' taken every 10 minutes throughout the trading day and is
available to subscribers within 5 minutes of the conclusion of each 10
minute period. For example, subscribers to the Intra-Day product will
receive the first calculation of intra-day data by 9:44 a.m. E.T.,
which represents data captured from 9:30 a.m. to 9:39 a.m. Subscribers
will receive the next update at 9:54 a.m., representing the data
previously provided together with data captured from 9:40 a.m. through
9:49 a.m., and so forth. Each update will represent the aggregate data
captured from the current ``snapshot'' and all previous ``snapshots.''
    The Exchange will establish a monthly subscriber fee for the Intra-
Day product by way of a separate proposed rule change, which the
Exchange will submit after the NOTO market data product is established.
    NOTO provides subscribers data that should enhance their ability to
analyze option trade and volume data, and to create and test trading
models and analytical strategies. The Exchange believes that NOTO is a
valuable tool that subscribers can use to gain comprehensive insight
into the trading activity in a particular option series.
    NOTO is virtually identical to a market data product currently
available on NASDAQ OMX PHLX LLC (``PHLX'') known as the PHLX Options
Trade Outline (``PHOTO'') market data product.\5\
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    \5\ See Securities Exchange Act Release No. 62887 (September 10,
2010), 75 FR 57092 (September 17, 2010) (SR-Phlx-2010-121).
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2. Statutory Basis
    NASDAQ believes that its proposal is consistent with Section 6(b)
of the Act \6\ in general, and furthers the objectives of Section
6(b)(5) of the Act \7\ in particular, in that it is designed to promote
just and equitable principles of trade, to remove impediments to and
perfect the mechanism of a free and open market and a national market
system, and, in general to protect investors and the public interest,
by establishing a market data product that enhances subscribers'
ability to make decisions on trading strategy, and by providing option
trade and volume data that should help bring about such decisions in a
timely manner.
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    \6\ 15 U.S.C. 78f(b).
    \7\ 15 U.S.C. 78f(b)(5).
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B. Self-Regulatory Organization's Statement on Burden on Competition

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

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

    No written comments were either solicited or received.

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

    Because the foregoing 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 after the date of the filing, or such
shorter time as the Commission may designate, it has become effective
pursuant to Section 19(b)(3)(A) of the Act \8\ and Rule 19b-4(f)(6) \9\
thereunder.
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    \8\ 15 U.S.C. 78s(b)(3)(A).
    \9\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)
requires a self-regulatory organization to give the Commission
written notice of its intent to file 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.
The Exchange has satisfied this requirement.
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    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.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File Number SR-NASDAQ-2011-144 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NASDAQ-2011-144. This
file number should be included on the subject line if e-mail is used.
To help the Commission process and review your comments more
efficiently, please use only one method. The Commission will post all
comments on the Commission's Internet Web site (http://www.sec.gov/rules/sro/shtml). Copies of the submission, all subsequent amendments,
all written statements with respect to the proposed rule change that
are filed with the Commission, and all written communications relating
to the proposed rule change between the Commission and any person,
other than those that may be withheld from the public in accordance
with the provisions of 5 U.S.C. 552, will be available for Web site
viewing and printing in the Commission's Public Reference Room, 100 F
Street, NE., Washington, DC 20549, on official business days between
the hours of 10 a.m. and 3 p.m. Copies of such filing also will be
available for inspection and copying at the principal office of the
Exchange. All comments received will be posted without change; the
Commission does not edit personal

identifying information from submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File No. SR-NASDAQ-2011-144 and should be submitted on
or before November 14, 2011.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\10\
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    \10\ 17 CFR 200.30-3(a)(12).
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Elizabeth M. Murphy,
Secretary.
[FR Doc. 2011-27379 Filed 10-21-11; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 83, Number 192 (Wednesday, October 3, 2018)]
[Proposed Rules]
[Pages 49894-49897]
[FR Doc No: 2018-21448]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R06-OAR-2008-0408; FRL-9984-28--Region 6]

Approval and Promulgation of Implementation Plans; Texas;
Interstate Transport Requirements for the 1997 Ozone National Ambient
Air Quality Standards

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: Pursuant to the Federal Clean Air Act (CAA or the Act), the
Environmental Protection Agency (EPA) is proposing to approve portions
of two Texas State Implementation Plan (SIP) submittals that pertain to
the good neighbor and interstate transport requirements of the CAA with
respect to the 1997 ozone National Ambient Air Quality Standards
(NAAQS). The good neighbor provision requires each state, in its SIP,
to prohibit emissions that will significantly contribute to
nonattainment, or interfere with maintenance, of a NAAQS in other
states. In this action, EPA is proposing

to approve the Texas SIP submittals as having met the requirements of
the good neighbor provision for the 1997 ozone NAAQS in accordance with
section 110 of the CAA.

DATES: Written comments must be received on or before November 2, 2018.

ADDRESSES: Submit your comments, identified by Docket No. EPA-R06-OAR-
2008-0408, at http://www.regulations.gov or via email to
[email protected]. 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 Carl Young,<PHONE_NUMBER>,
[email protected]. 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 the 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: Carl Young,<PHONE_NUMBER>,
[email protected]. To inspect the hard copy materials, please schedule
an appointment with Mr. Young or Mr. Bill Deese at<PHONE_NUMBER>.

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

I. Background

A. The 1997 8-Hour Ozone NAAQS and Interstate Transport of Air
Pollution

    Under section 109 of the CAA, we establish NAAQS to protect human
health and public welfare. In 1997, we established new 8-hour primary
and secondary ozone NAAQS of 0.08 parts per million (62 FR 38856, July
18, 1997).\1\ Ground level ozone is formed when nitrogen oxides
(NOX) and volatile organic compounds (VOCs) react in the
presence of sunlight.
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    \1\ In 2008, we revised the 8-hour ozone NAAQS to 0.075 ppm (73
FR 16436, March 27, 2008) and in 2015 we revised the 8-hour ozone
NAAQS to 0.070 ppm (80 FR 65292, October 26, 2015). This proposal
pertains to the 1997 8-hour ozone NAAQS only.
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    Section 110(a)(1) of the CAA requires states to submit, within
three years after promulgation of a new or revised standard, SIPs
meeting the applicable ``infrastructure'' elements set forth in Section
110(a)(2). One of these applicable infrastructure elements, CAA section
110(a)(2)(D)(i), requires SIPs to contain ``good neighbor'' provisions
to prohibit certain adverse air quality effects on neighboring states
due to interstate transport of pollution. There are four sub-elements
within CAA section 110(a)(2)(D)(i). This action reviews how the first
two sub-elements of the good neighbor provisions at CAA section
110(a)(2)(D)(i)(I) were addressed in the infrastructure SIP submittals
from Texas for the 1997 8-hour ozone NAAQS. These sub-elements require
that each SIP for a new or revised NAAQS contain adequate provisions to
prohibit any emissions activity within the state from emitting air
pollutants that will ``contribute significantly to nonattainment'' or
``interfere with maintenance'' of the applicable air quality standard
in any other state.
    The EPA has addressed the interstate transport requirements of CAA
section 110(a)(2)(D)(i)(I) with respect to the 1997 8-hour ozone NAAQS
in several past regulatory actions. Most relevant to this action, we
promulgated the Clean Air Interstate Rule (CAIR) in 2005 to address the
requirements of the good neighbor provision for the 1997 fine
particulate PM2.5 and 1997 ozone NAAQS (May 12, 2005, 70 FR
25172). While Texas was included in CAIR with respect to the 1997
PM2.5 NAAQS, we determined that Texas would not
significantly contribute to nonattainment or interfere with maintenance
of the 1997 ozone NAAQS in other states. However, CAIR was remanded by
the D.C. Circuit in North Carolina v. EPA, 531 F.3d 896 (D.C. Cir.
2008), modified on reh'g, 550 F.3d 1176. The court determined that CAIR
was ``fundamentally flawed'' and ordered EPA to ``redo its analysis
from the ground up.'' 531 F.3d at 929.
    In 2011 we promulgated the Cross-State Air Pollution Rule (CSAPR)
to address the remand of CAIR.\2\ CSAPR addressed the state and federal
obligations under CAA section 110(a)(2)(D)(i)(I) to prohibit air
pollution contributing significantly to nonattainment in, or
interfering with maintenance by, any other state with regard to the
1997 8-hour ozone NAAQS and the 1997 annual PM2.5 NAAQS, as
well as the 2006 24-hour PM2.5 NAAQS. To address Texas'
transport obligation under CAA section 110(a)(2)(D)(i)(I) with regard
to the 1997 8-hour ozone NAAQS, CSAPR established Federal
Implementation Plan (FIP) requirements for affected electric generating
units (EGUs) in Texas, including an emissions budget that applied to
the EGUs' collective ozone-season emissions of NOX. The
CSAPR budgets were to be implemented in two phases, with phase 1 to be
implemented beginning with the 2012 ozone season and phase 2 to be
implemented beginning with the 2014 ozone season.\3\ Due to litigation,
phase 1 of CSAPR was not implemented until 2015 and phase 2 was set to
be implemented beginning in 2017. (81 FR 13275, March 14, 2016).
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    \2\ Federal Implementation Plans; Interstate Transport of Fine
Particulate Matter and Ozone and Correction of SIP Approvals, 76 FR
48208 (August 8, 2011) (codified as amended at 40 CFR 52.38 and
52.39 and 40 CFR part 97).
    \3\ However, the implementation of the emissions budgets was
stayed by the D.C. Circuit in December 2011 pending further
litigation. The D.C. Circuit initially issued a decision in EME
Homer City Generation, L.P. v. EPA, 696 F.3d 7 (D.C. Cir. 2012) (EME
Homer City I), vacating CSAPR, but in April 2014, the Supreme Court
issued a opinion reversing the D.C. Circuit and remanding the case
for further proceedings. EPA v. EME Homer City Generation, L.P., 134
S. Ct. 1584, 1600-01 (2014). After the Supreme Court issued its
decision, the D.C. Circuit granted a motion from EPA to lift the
stay and toll the compliance timeframes by three years. See
Respondents' Motion to Lift the Stay Entered on December 30, 2011,
Document #1499505, EME Homer City Generation, L.P. v. EPA, No. 11-
1302 (D.C. Cir. filed June 26, 2014); Order, Document #1518738, EME
Homer City Generation, L.P. v. EPA, No. 11-1302 (D.C. Cir. issued
Oct. 23, 2014).
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    In subsequent litigation (See generally EME Homer City Generation,
L.P. v. EPA, 795 F.3d 118 (D.C. Cir. Ct. App. 2015) (``EME Homer City
II'' herein)), the court reviewed our ability to regulate interstate
air pollution pursuant to the good neighbor provision. The court in EME
Homer City II declared the CSAPR phase 2 ozone season emission budgets
of 11 states invalid, including Texas, holding that those budgets over-
control with respect to the downwind air quality problems to which
those states were linked for the 1997 ozone NAAQS.\4\
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    \4\ EME Homer City II, 795 F.3d at 129-30, 138 (D.C. Cir. Ct.
App. 2015).
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    In our response to Homer City II, we addressed Texas's ozone-season
emissions budget in the regulation,

CSAPR Update, which was promulgated in 2016 to address the requirements
of the good neighbor provision for the 2008 ozone NAAQS.\5\ In the
original 2011 CSAPR, EPA noted that the reductions for 11 states,
including Texas, may not be sufficient to fully eliminate all
significant contribution to nonattainment or interference with
maintenance for certain downwind areas with respect to the 1997 ozone
NAAQS because EPA's analysis projected continued nonattainment and
maintenance problems at downwind receptors to which these upwind states
were linked after implementation of the CSAPR trading programs.
Specifically, exceedances were expected in Baton Rouge, Louisiana;
Houston, Texas; and Allegan, Michigan according to the remedy case
modeling conducted for the original CSAPR rule. The CSAPR Update used
2017 as the analytic year for the air quality modeling to determine
nonattainment and maintenance receptors and states linked to those
receptors. We evaluated this 2017 modeling to determine whether
additional emission reductions would be needed in these 11 states,
including Texas, to address the states' full good neighbor obligation
for the 1997 ozone NAAQS.
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    \5\ CSAPR Update Rule for the 2008 ozone NAAQS, 81 FR 74504,
October 26, 2016.
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    Despite our conclusion in the 2011 CSAPR that the 1997 ozone
transport problems to which Texas was linked were not fully resolved,
the court concluded in EME Homer City II that the ozone season emission
budget finalized for Texas may result in over-control as to the ozone
air quality problems to which the state was linked. 795 F.3d at 129-30.
In response to this determination, we removed Texas's phase 2 ozone
season budget as a constraint in the 2017 air quality modeling
conducted for the CSAPR Update. EPA concluded that, even in the absence
of this constraint, the 2017 air quality modeling shows that the
predicted average design values (DVs) \6\ used to identify
nonattainment receptors and the maximum DVs used to identify
maintenance receptors would both be below the level of the 1997 ozone
NAAQS for the downwind receptors of concern to which Texas was linked
in the original CSAPR rulemaking with respect the 1997 ozone NAAQS.
Accordingly, we found that Texas emissions would no longer contribute
significantly to nonattainment in, or interfere with maintenance by,
any other state with respect to the 1997 ozone NAAQS. (See generally,
81 FR 74504). Consistent with this finding, we removed the FIP
requirements associated with the 1997 ozone NAAQS, and sources in Texas
were no longer subject to the phase 2 ozone season budget calculated to
address that standard. See 40 CFR 52.38(b)(2)(ii) (relieving sources in
Texas of the obligation to comply with the remanded phase 2 ozone
season emission budgets after 2016).\7\
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    \6\ DVs are used to determine whether a NAAQS is being met.
    \7\ EPA notes that, because Texas was linked to downwind air
quality problems with respect to the 2008 ozone NAAQS in its
analysis, the EPA promulgated a new ozone season NOX
emission budget to address that standard at 40 CFR 97.810(a).
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B. Texas SIP Submittals Pertaining to the 1997 8-Hour Ozone NAAQS and
Interstate Transport of Air Pollution

    Texas made the following SIP submittals to address CAA requirements
to prohibit emissions which will significantly contribute to
nonattainment or interfere with maintenance of the 1997 ozone NAAQS in
other states: (1) An April 4, 2008 submittal stating that the state had
addressed any potential CAA section 110(a)(2) infrastructure issues
associated with the 1997 ozone NAAQS, including the first two sub-
elements for interstate transport in (CAA section 110(a)(2)(D)(i)(I))
and (2) a separate, but similar May 1, 2008 submittal which discussed
how the first two sub-elements of the good neighbor provision were
addressed with respect to the 1997 ozone standards. For the reasons
described below, this action proposes to approve the state's two SIP
submittals with respect to the state's conclusions regarding the first
two sub-elements of the good neighbor provisions at CAA section
110(a)(2)(D)(i)(I) for the 1997 ozone NAAQS. See Docket No. EPA-R06-
OAR-2008-0408 in www.regulations.gov.

II. The EPA's Evaluation

    Each of the above-referenced Texas SIP submittals relied on (1)
EPA's CAIR modeling document, ``Technical Support Document for the
Final Clean Air Interstate Rule--Air Quality Modeling, March 2005'' \8\
and (2) emission controls found in the Texas SIP to support a
conclusion that the Texas SIP had adequate provisions to prohibit
emissions which will significantly contribute to nonattainment or
interfere with maintenance of the 1997 ozone NAAQS in any other state.
The SIP submittals rely on the conclusion in the CAIR rulemaking that
Texas would not significantly contribute to nonattainment or interfere
with maintenance of the 1997 ozone NAAQS in downwind states. While CAIR
was still in place at the time the state submitted its SIPs, as
discussed above, the rule was remanded by the D.C. Circuit in 2008
because the court found it was ``fundamentally flawed'' and must be
replaced ``from the ground up.'' North Carolina, 531 F.3d at 929-30.
Accordingly, we cannot approve the state's SIP submittals based on the
CAIR analysis. However, more recent information provides support for
our proposed approval of the conclusions in the SIP submittals that the
state will not significantly contribute to nonattainment or interfere
with maintenance of the 1997 ozone NAAQS in any other state.
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    \8\ Document EPA-HQ-OAR-2003-0053-2151 in regulations.gov.
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    The updated air quality modeling conducted for the original CSAPR
rulemaking projected the effect of emissions on ambient air quality
monitors (receptors). The modeling projected that in 2012: (1) A
receptor located in East Baton Rouge Parish, Louisiana (monitor ID
220330003) would have difficulty attaining and maintaining the 1997 8-
hour ozone NAAQS; and, (2) A receptor located in Allegan County,
Michigan (monitor ID 260050003) would have difficulty maintaining the
1997 8-hour ozone NAAQS (76 FR 48208, 48236, August 8, 2011). The
modeling also showed that Texas emissions were projected to contribute
more than the threshold amount of ozone pollution necessary to be
considered ``linked'' to these receptors for the 1997 8-hour ozone
NAAQS (76 FR 48208, 48246, August 8, 2011). These were the only ozone
receptors with projected air quality problems to which Texas was found
to be linked.
    In CSAPR we used air quality projections for the year 2012, which
was also the intended start year for implementation of the CSAPR Phase
1 EGU emission budgets, to identify receptors projected to have air
quality problems. The CSAPR final rule record also contained air
quality projections for 2014, which was the intended start year for
implementation of the CSAPR Phase 2 EGU emission budgets. The 2014
modeling results projected that before considering the emissions
reductions anticipated from implementation of CSAPR: (1) The East Baton
Parish receptor would have an average 8-hour ozone DV of 84.1 parts per
billion (ppb) and a maximum DV of 87.7 ppb; and, (2) The Allegan
County, Michigan

would have maximum DV of 83.6 ppb.\9\ We used a value of 85 ppb to
determine whether a particular ozone receptor should be identified as
having air quality problems that may trigger transport obligations in
upwind states with regard to the 1997 8-hour ozone NAAQS (76 FR 48208,
48236).
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    \9\ See projected 2014 base case average and maximum DVs for
these monitors at pages B-14 and B-16 of the June 2011 Air Quality
Modeling Final Rule Technical Support Document for CSAPR, Document
ID No. EPA-HQ-OAR-2009-0491-4140, available in regulations.gov.
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    The 2014 modeling results show that the Allegan County, Michigan
monitor which Texas was linked to in the 2012 modeling was no longer
projected to have air quality problems sufficient to trigger transport
obligations with regard to the 1997 8-hour ozone NAAQS. Thus, Texas was
no longer projected to interfere with maintenance of the 1997 ozone
NAAQS at the Allegan County receptor in 2014. However, the 2014
modeling results continued to project that the East Baton Parish
receptor would have problems maintaining the 1997 ozone NAAQS.
    As discussed above, in response to the remand of Texas's CSAPR
phase 2 ozone season budget by the D.C. Circuit in EME Homer City II,
EPA reviewed the 2017 air quality modeling conducted for the CSAPR
Update. EPA concluded that, even in the absence of Texas's CSAPR
budget, both the Baton Rouge and Allegan receptors would have average
and maximum DVs below the level of the 1997 ozone NAAQS for the
downwind receptors of concern to which Texas was linked in the original
CSAPR rulemaking with respect the 1997 ozone NAAQS. Accordingly, EPA
found that Texas emissions would no longer contribute significantly to
nonattainment in, or interfere with maintenance by, any other state
with respect to the 1997 ozone NAAQS at either receptor or in any other
state. (81 FR 74525-26). This conclusion is based on EPA's most recent
modeling analysis and is supported by the fact that the Baton Rouge
area has monitored attainment of the 1997 ozone standard since 2008.

III. Proposed Action

    We are proposing to approve the portions of the April 4, 2008 and
May 1, 2008 Texas SIP submittals as they pertain to the requirements of
CAA section 110(a)(2)(D)(i)(I) with respect to the 1997 ozone NAAQS. We
propose to find that the conclusion in the state's SIP submittals is
consistent with EPA's conclusion regarding the Texas's good neighbor
obligation, that emissions from Texas will not significantly contribute
to nonattainment or interfere with maintenance of the 1997 ozone NAAQS
in any other state.

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, the 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 Orders
12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21,
2011);
     Is not an Executive Order 13771 (82 FR 9339, February 2,
2017) regulatory action because SIP approvals are exempted under
Executive Order 12866;
     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, 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 and will
not impose substantial direct costs on tribal governments or preempt
tribal law as specified by Executive Order 13175 (65 FR 67249, November
9, 2000).

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Ozone.

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

    Dated: September 26, 2018.
Anne Idsal,
Regional Administrator, Region 6.
[FR Doc. 2018-21448 Filed 10-2-18; 8:45 am]
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[Federal Register Volume 78, Number 161 (Tuesday, August 20, 2013)]
[Notices]
[Page 51182]
[FR Doc No: 2013-20162]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 14368-000-CO]

Catamount Metropolitan District; Notice of Availability of Final
Environmental Assessment

    In accordance with the National Environmental Policy Act of 1969
and the Federal Energy Regulatory Commission's regulations, 18 CFR Part
380 (Order No. 486, 52 FR 47879), the Office of Energy Projects has
reviewed the application for a small hydropower project exemption for
the Catamount Hydroelectric Project, to be located at the existing
Catamount dam and Lake Catamount in Routt County, near the City of
Steamboat Springs, in the state of Colorado, and has prepared a final
Environmental Assessment (final EA). In the final EA, Commission staff
analyzed the potential environmental effects of the proposed project
and concludes that issuing an exemption for the project, with
appropriate environmental measures, would not constitute a major
federal action significantly affecting the quality of the human
environment.
    A copy of the final EA is on file with the Commission and is
available for public inspection. The EA may also be viewed on the
Commission's Web site 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, contact
FERC Online Support at<EMAIL_ADDRESS>or toll-free at 1-
866-208-3676, or for TTY,<PHONE_NUMBER>.

    Dated: August 13, 2013.
Kimberly D. Bose,
Secretary.
[FR Doc. 2013-20162 Filed 8-19-13; 8:45 am]
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[Federal Register Volume 88, Number 73 (Monday, April 17, 2023)]
[Notices]
[Pages 23431-23433]
[FR Doc No: 2023-08066]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-N-2480]

Rare Disease Endpoint Advancement Pilot Program Workshop: Novel
Endpoints for Rare Disease Drug Development; Public Workshop; Request
for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop; request for comments.

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

SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
announcing a public workshop entitled ``Rare Disease Endpoint
Advancement Pilot Program Workshop: Novel Endpoints for Rare Disease
Drug Development.'' Convened by the Duke-Robert J. Margolis, MD Center
for Health Policy (Duke-Margolis) and supported by a cooperative
agreement between FDA and Duke-Margolis, the workshop will include
discussions of the Rare Disease Endpoint Advancement (RDEA) Pilot
Program and novel endpoint development for rare disease drug
development.

DATES: The public workshop will be held virtually on June 7, 2023, and
June 8, 2023, from 1 p.m. to 5 p.m., Eastern Time. Either electronic or
written comments on this public workshop must be submitted by July 23,
2023. See the SUPPLEMENTARY INFORMATION section for registration date
and information.

ADDRESSES: The public workshop will be held virtually using the Zoom
platform. The link for the public workshop will be sent to registrants
upon registration.
    You may submit comments as follows. Please note that late, untimely
filed comments will not be considered. The https://www.regulations.gov
electronic filing system will accept comments until 11:59 p.m. Eastern
Time on July 23, 2023. Comments received by mail/hand delivery/courier
(for written/paper submissions) will be considered timely if they are
received on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.

     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked, and identified
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2022-N-2480 for ``Rare Disease Endpoint Advancement Pilot Program
Workshop: Novel Endpoints for Rare Disease Drug Development.'' Received
comments, those filed in a timely manner (see ADDRESSES), will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Mary Jo Salerno, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD 20993,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    This public workshop is intended to support the RDEA Pilot Program
consistent with the requirements under section 3208 of the Food and
Drug Omnibus Reform Act of 2022 (FDORA). Section 3208 of FDORA requires
FDA to establish a pilot program to provide increased interaction with
sponsors of rare disease drug development programs for purposes of
advancing the development of efficacy endpoints, including surrogate
and intermediate endpoints, for drugs intended to treat rare diseases.
Section 3208 of FDORA also requires FDA to conduct up to three public
workshops to discuss various topics relevant to the development of
endpoints for rare diseases on or before September 30, 2026. This is
the first of up to three public workshops to satisfy the FDORA
requirement.
    The public workshop is also intended to meet a performance goal
under the FDA User Fee Reauthorization Act of 2022, in accordance with
the PDUFA Reauthorization Performance Goals and Procedures Fiscal Years
2023 Through 2027 letter (PDUFA VII Commitment Letter), which is
available at https://www.fda.gov/media/151712/download. Specifically,
section I.K.4 of the PDUFA VII Commitment Letter, ``Advancing
Development of Drugs for Rare Diseases'' (https://www.fda.gov/media/151712/download), outlines commitments, including up to three public
workshops to discuss various topics relevant to endpoint development
for rare diseases.

II. Topics for Discussion at the Public Workshop

    The purpose of this public workshop is to: (1) provide an overview
of the RDEA Pilot Program (a joint program of the Center for Drug
Evaluation and Research and the Center for Biologics Evaluation and
Research), (2) discuss the scientific and technical issues associated
with developing study endpoints for rare diseases and highlight
resources to assist with addressing these issues, (3) discuss lessons
learned from previous PDUFA meeting programs that can be applied to the
RDEA Pilot Program, and (4) provide opportunity for public comment on
the RDEA Pilot Program and issues associated with rare disease endpoint
development.
    Meeting sessions will focus on: (1) the RDEA Pilot Program and
process, (2) elements of RDEA proposal and meeting packages, (3)
addressing issues in developing rare disease endpoints, and (4)
experience with other FDA pilot programs. At the end of the public
workshop, there will be an opportunity for public comment.
    Meeting updates, the agenda, and background materials (if any) will
be made available at https://duke.is/5ca3k prior to the workshop.

III. Participating in the Public Workshop

    Registration: To register for the public workshop, please visit the
following website: https://duke.is/5ca3k. Please provide complete
contact information for each attendee, including name, title,
affiliation, address, email, and telephone. Registration will end at
11:59 p.m. Eastern Time on June 6, 2023.
    Registration is free, and persons interested in attending this
public workshop must register to receive a link to the meeting.
Registrants will receive a confirmation email after they register.
    If you need special accommodations due to a disability, please
contact [email protected] no later than May 5, 2023. Please note,
closed captioning will be available automatically.
    Requests for Oral Comments: During online registration you may
indicate if you wish to speak during a public comment session. We will
do our best to accommodate requests to make public comments.
Individuals and organizations with common interests are urged to
consolidate or coordinate their comment and request time for joint
commentary. All requests to make oral comments must be received by
11:59 p.m. Eastern Time on May 26, 2023. FDA will determine the amount
of time

allotted to each commenter and the approximate time each comment is to
begin and will select and notify participants by June 2, 2023.
    Transcript: Please be advised that as soon as a transcript of the
public workshop is available, it will be accessible at https://duke.is/5ca3k. The transcript will also be available at https://www.regulations.gov and may be viewed at the Dockets Management Staff
(see ADDRESSES).

    Dated: April 12, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-08066 Filed 4-14-23; 8:45 am]
BILLING CODE 4164-01-P