[Federal Register Volume 81, Number 239 (Tuesday, December 13, 2016)]
[Rules and Regulations]
[Pages 89870-89876]
[FR Doc No: 2016-29561]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 81

[EPA-HQ-OAR-2014-0464; FRL-9956-10-OAR]

Air Quality Designations for the 2010 Sulfur Dioxide
(SO2) Primary National Ambient Air Quality Standard--
Supplement to Round 2 for Four Areas in Texas: Freestone and Anderson
Counties, Milam County, Rusk and Panola Counties, and Titus County

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This rule establishes the initial air quality designations for
four areas in Texas for the 2010 primary sulfur dioxide
(SO2) National Ambient Air Quality Standard (NAAQS). The
Environmental Protection Agency (EPA) is designating three of the areas
as nonattainment because they do not meet the NAAQS. One area is being
designated unclassifiable because it cannot be classified on the basis
of available information as meeting or not meeting the NAAQS. The
designations are based on the weight of evidence for each area,
including available air quality monitoring data and air quality
modeling. For the areas designated nonattainment by this rule, the
Clean Air Act (CAA) directs the state of Texas to undertake certain
planning and pollution control activities to attain the SO2
NAAQS as expeditiously as practicable. This action is a supplement to
the final rule addressing the second round of area designations for the
2010 SO2 NAAQS, which the EPA Administrator signed on June
30, 2016.

DATES: The effective date of this rule is January 12, 2017.

ADDRESSES: The EPA has established a docket for the second round of
designations, including this supplemental action, under Docket ID No.
EPA-HQ-OAR-2014-0464. All documents in the docket are listed in the
http://www.regulations.gov Web site. Although listed in the index, some
information is not publicly available, e.g., 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 electronically
in http://www.regulations.gov.
    In addition, the EPA has established a Web site for the 2010
SO2 NAAQS designations rulemakings at: https://

www.epa.gov/sulfur-dioxide-designations. The Web site includes the
EPA's final SO2 designations, as well as state and tribal
initial recommendation letters, the EPA's letters announcing
modifications to those recommendations, technical support documents,
responses to comments and other related technical information.

FOR FURTHER INFORMATION CONTACT:  For general questions concerning this
supplemental action, please contact Liz Etchells, U.S. EPA, Office of
Air Quality Planning and Standards, Air Quality Planning Division,
C539-04, Research Triangle Park, NC 27711, telephone<PHONE_NUMBER>,
email at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:
    U.S. EPA Regional Office Contacts: Region VI--Jim Grady, telephone
(214) 665-6745, email at<EMAIL_ADDRESS>    The public may inspect the rule and area-specific technical support
information at the following location: Air Planning Section, EPA Region
VI, 1445 Ross Avenue, Dallas, TX 75202.

Table of Contents

    The following is an outline of the preamble.

I. Preamble Glossary of Terms and Acronyms
II. What is the purpose of this supplemental action?
III. What is the 2010 SO2 NAAQS and what are the health
concerns that it addresses?
IV. What are the CAA requirements for air quality designations and
what action has the EPA taken to meet these requirements?
V. What guidance did the EPA issue and how did the EPA apply the
statutory requirements and applicable guidance to determine area
designations and boundaries?
VI. What air quality information has the EPA used for these
designations?
VII. How do the designations supplementing the Round 2 designations
affect Indian country?
VIII. Where can I find information forming the basis for this action
and exchanges between the EPA, states and tribes related to this
action?
IX. Environmental Justice Concerns
X. Statutory and Executive Order Reviews
    A. Executive Order 12866: Regulatory Planning and Review and
Executive Order 13563: Improving Regulation and Regulatory Review
    B. Paperwork Reduction Act (PRA)
    C. Regulatory Flexibility Act (RFA)
    D. Unfunded Mandates Reform Act (URMA)
    E. Executive Order 13132: Federalism
    F. Executive Order 13175: Consultation and Coordination With
Indian Tribal Governments
    G. Executive Order 13045: Protection of Children From
Environmental Health Risks and Safety Risks
    H. Executive Order 13211: Actions That Significantly Affect
Energy Supply, Distribution, or Use
    I. National Technology Transfer and Advancement Act (NTTAA)
    J. Executive Order 12898: Federal Actions To Address
Environmental Justice in Minority Populations and Low-Income
Populations
    K. Congressional Review Act (CRA)
    L. Judicial Review

I. Preamble Glossary of Terms and Acronyms

    The following are abbreviations of terms used in the preamble.

APA Administrative Procedure Act
CAA Clean Air Act
CFR Code of Federal Regulations
DC District of Columbia
EO Executive Order
EPA Environmental Protection Agency
FR Federal Register
NAAQS National Ambient Air Quality Standards
NTTAA National Technology Transfer and Advancement Act
OMB Office of Management and Budget
SO2 Sulfur Dioxide
SOX Sulfur Oxides
RFA Regulatory Flexibility Act
UMRA Unfunded Mandate Reform Act of 1995
TAR Tribal Authority Rule
TAD Technical Assistance Document
TSD Technical Support Document
US United States

II. What is the purpose of this supplemental action?

    The purpose of this final action is to announce and promulgate
initial air quality designations for four areas in Texas for the 2010
primary SO2 NAAQS, in accordance with the requirements of
the CAA. The EPA is designating three of these areas as nonattainment,
and one area as unclassifiable. As discussed in Section IV of this
document, the EPA is designating areas for the 2010 SO2
NAAQS in multiple rounds under a court-ordered schedule pursuant to a
consent decree. The EPA completed the first round of SO2
designations in an action signed by the Administrator on July 25, 2013
(78 FR 47191; August 5, 2013). In that action, the EPA designated 29
areas in 16 states as nonattainment, based on air quality monitoring
data.
    The court order required the EPA Administrator to sign a notice
designating areas in a second round that contained sources meeting
certain criteria no later than July 2, 2016. See Sierra Club and NRDC
v. McCarthy, No. 3:13-cv-3953-SI (N.D. Cal.) (March 2, 2015). The four
areas in Texas covered by this action met those criteria, and the EPA
responded to state recommendations for Round 2 designations, including
Texas' recommendations for these four areas, on February 11, 2016
(Letter from Ron Curry, EPA Region 6 Administrator, to Governor of
Texas, Honorable Greg Abbott). In the second round of SO2
designations signed on June 30, 2016, the EPA designated 61 areas in 24
states (including eight other areas in Texas): four nonattainment
areas, 41 unclassifiable/attainment areas and 16 unclassifiable areas
(81 FR 45039; July 12, 2016). However, by a series of stipulations of
the parties in Sierra Club and NRDC v. McCarthy and orders of the
Court, the deadline to promulgate designations was extended to November
29, 2016, for the four areas in Texas that are the subject of this
supplemental action. This action to designate four Texas areas further
discharges the EPA's duty to issue the second round of SO2
designations, and uses the same administrative record as supported by
the action signed on June 30, 2016, that addressed eight other Texas
areas and other areas in the United States, as supplemented by
additional materials further addressing these four Texas areas.
    In this supplementary designation action, the list of areas being
designated in Texas and the boundaries of each area appear in the
tables within the regulatory text at the end of this notice. These
designations are based on the EPA's technical assessment of and
conclusions regarding the weight of evidence for each area, including
but not limited to available air quality monitoring data or air quality
modeling. With respect to air quality monitoring data, the EPA
considered data from the most recent calendar years 2012-2015. In the
modeling runs conducted by industry and members of the public, the air
quality impacts of the actual emissions for the 3-year periods 2012-
2014 or 2013-2015 were assessed.
    For the areas being designated nonattainment, the CAA directs
states to develop and submit to the EPA State Implementation Plans
within 18 months of the effective date of this final rule that meet the
requirements of sections 172(c) and 191-192 of the CAA and provide for
attainment of the NAAQS as expeditiously as practicable, but not later
than 5 years from the effective date of this final rule. We also note
that under the EPA's SO2 Data Requirements Rule in 40 CFR
part 51, subpart BB (80 FR 51052; August 21, 2015), the EPA expects to
receive additional air quality characterization for the one area in
Milam County, Texas, designated unclassifiable in this action, and the
agency will consider such data, as appropriate, in future actions.

III. What is the 2010 SO2 NAAQS and what are the health
concerns that it addresses?

    The Administrator signed a final rule revising the primary
SO2 NAAQS on June 2, 2010. The rule was published in the
Federal Register on June 22, 2010 (75 FR 35520) and became effective on
August 23, 2010. Based on the Administrator's review of the air quality
criteria for oxides of sulfur and the primary NAAQS for oxides of
sulfur as measured by SO2, the EPA revised the primary
SO2 NAAQS to provide requisite protection of public health
with an adequate margin of safety. Specifically, the EPA established a
new 1-hour SO2 standard at a level of 75 parts per billion
(ppb), which is met at an ambient air quality monitoring site when the
3-year average of the annual 99th percentile of 1-hour daily maximum
concentrations is less than or equal to 75 ppb, as determined in
accordance with Appendix T of 40 CFR part 50. 40 CFR 50.17(a)-(b). The
EPA also established provisions to revoke both the existing 24-hour and
annual primary SO2 standards, subject to certain conditions.
40 CFR 50.4(e).
    Additional information regarding the current scientific evidence on
the health impacts of short-term exposures to SO2 is
provided in the Federal Register notice containing the final rule for
the second round of SO2 designations for other areas that
was signed on June 30, 2016. See 81 FR 45041.

IV. What are the CAA requirements for air quality designations and what
action has the EPA taken to meet these requirements?

    After the EPA promulgates a new or revised NAAQS, the EPA is
required to designate all areas of the country as either
``nonattainment,'' ``attainment,'' or ``unclassifiable,'' for that
NAAQS pursuant to section 107(d)(1) of the CAA. Section 107(d)(1)(A)(i)
of the CAA defines a nonattainment area as ``any area that does not
meet (or that contributes to ambient air quality in a nearby area that
does not meet) the national primary or secondary ambient air quality
standard for the pollutant.'' If an area meets either prong of this
definition, then the EPA is obligated to designate the area as
``nonattainment.'' This provision also defines an attainment area as
any area other than a nonattainment area that meets the NAAQS and an
unclassifiable area as any area that cannot be classified on the basis
of available information as meeting or not meeting the NAAQS.
    Additional information regarding the process for designating areas
following promulgation of a new or revised NAAQS pursuant to section
107(d) of the CAA and how the EPA is applying this process to the
designation of areas under the 2010 SO2 NAAQS is provided in
the final rule addressing the second round of SO2
designations for other areas signed on June 30, 2016. See 81 FR 45041.
For this supplemental action, the EPA reiterates that CAA section
107(d) provides the agency with discretion to determine how best to
interpret the terms in the definition of a nonattainment area (e.g.,
``contributes to'' and ``nearby'') for a new or revised NAAQS, given
considerations such as the nature of a specific pollutant, the types of
sources that may contribute to violations, the form of the standards
for the pollutant, and other relevant information. In particular, the
EPA's position is that the statute does not require the agency to
establish bright line tests or thresholds for what constitutes
``contribution'' or ``nearby'' for purposes of designations.\1\
---------------------------------------------------------------------------

    \1\ This view was confirmed in Catawba County v. EPA, 571 F.3d
20 (D.C. Cir. 2009).
---------------------------------------------------------------------------

    Similarly, the EPA's position is that the statute permits the EPA
to evaluate the appropriate application of the term ``area'' to include
geographic areas based upon full or partial county boundaries, as may
be appropriate for a particular NAAQS. For example, CAA section
107(d)(1)(B)(ii) explicitly provides that the EPA can make
modifications to designation recommendations for an area ``or portions
thereof,'' and under CAA section 107(d)(1)(B)(iv) a designation remains
in effect for an area ``or portion thereof'' until the EPA redesignates
it.
    As explained in more detail in the final rule addressing the second
round of SO2 designations for other areas, the EPA completed
the first round of SO2 designations for 29 areas on July 25,
2013 (78 FR 47191), and intends to complete up to three more rounds of
designations to address all remaining areas pursuant to a schedule
contained in a consent decree and enforceable order entered by the U.S.
District Court for the Northern District of California on March 2,
2015. See 81 FR 45042.
    The court order specifies that in this second round of
SO2 designations the EPA must designate two groups of areas:
(1) Areas that have newly monitored violations of the 2010
SO2 NAAQS and (2) areas that contain any stationary sources
that had not been announced as of March 2, 2015, for retirement and
that, according to the EPA's Air Markets Database, emitted in 2012
either (i) more than 16,000 tons of SO2, or (ii) more than
2,600 tons of SO2 with an annual average emission rate of at
least 0.45 pounds of SO2 per one million British thermal
units (lbs SO2/mmBTU).
    On March 20, 2015, the EPA sent letters to Governors notifying them
of the schedule for completing the remaining designations for the 2010
1-hour SO2 NAAQS. The EPA offered states, including Texas,
the opportunity to submit updated recommendations and supporting
information for the EPA to consider for the affected areas. The EPA
also notified states that the agency had updated its March 24, 2011,
SO2 designations guidance to support analysis of
designations and boundaries for the next rounds of designations. All of
the states, including Texas, with affected areas submitted updated
designation recommendations.
    In a letter dated February 11, 2016, the EPA notified Texas of its
intended designation of twelve Round 2 areas, including the four areas
in Texas addressed in this final notice, as either nonattainment,
unclassifiable/attainment, or unclassifiable for the SO2
NAAQS. Texas then had the opportunity to demonstrate why they believed
the EPA's intended modification of their updated recommendations may be
inappropriate. Although not required, as the EPA had done for the first
round of SO2 designations, the EPA also provided an
opportunity for members of the public to comment on the EPA's February
2016 response letters. The EPA published a notice of availability and
public comment period for the intended designation on March 1, 2016 (81
FR 10563). The public comment period closed on March 31, 2016. The
updated recommendations, the EPA's February 2016 responses to those
letters, any modifications, and the subsequent state and public comment
letters, are in the docket for the Round 2 SO2 designations
at Docket ID No. EPA-HQ-OAR-2014-0464 and are available on the
SO2 designations Web site.
    Before taking final action, however, the parties to Sierra Club and
NRDC v. McCarthy filed the first in a series of joint stipulations
extending the deadline for these four areas in Texas, out to November
29, 2016.\2\ In the final rule signed on June 30, 2016, the EPA
promulgated designations for the Round 2 areas for which no extensions
in the deadline had been obtained (including the eight other Texas
areas) and explained the ongoing process for completing SO2
designations for all

areas of the country by December 31, 2020 (see generally 81 FR 45042-
43).
---------------------------------------------------------------------------

    \2\ The parties to Sierra Club and NRDC v. McCarthy also filed a
joint stipulation extending the Round 2 designation deadline for the
Muskogee County Area in Oklahoma out to December 31, 2016.
---------------------------------------------------------------------------

    In these supplemental Round 2 designations, and consistent with the
extended deadline under the consent decree, the EPA must designate the
four areas in Texas associated with the following sources by November
29, 2016: The Big Brown Steam Electric Station in the Freestone and
Anderson Counties Area, the Sandow Power Station in the Milam County
Area, the Martin Lake Electrical Station in the Rusk and Panola
Counties Area, and the Monticello Steam Electric Station in the Titus
County Area.

V. What guidance did the EPA issue and how did the EPA apply the
statutory requirements and applicable guidance to determine area
designations and boundaries?

    Following entry of the March 2, 2015, court order, the EPA issued
updated designations guidance through a March 20, 2015, memorandum from
Stephen D. Page, Director, U.S. EPA, Office of Air Quality Planning and
Standards, to Air Division Directors, U.S. EPA Regions 1-10 titled,
``Updated Guidance for Area Designations for the 2010 Primary Sulfur
Dioxide National Ambient Air Quality Standard.'' As explained in the
final rule addressing the second round of SO2 designations
for other areas signed on June 30, 2016, this guidance contains the
factors the EPA intends to evaluate in determining the appropriate
designations and associated boundaries for all remaining areas in the
country, including: (1) Air quality characterization via ambient
monitoring or dispersion modeling results; (2) emissions-related data;
(3) meteorology; (4) geography and topography; and (5) jurisdictional
boundaries. See 81 FR at 45043. Additional information regarding
relevant guidance relied upon in designating the other second round
areas and that is also used in this supplemental action is available in
the previously issued final rule. See id.

VI. What air quality information has the EPA used for these
designations?

    To inform designations for the SO2 NAAQS, air agencies
have the flexibility to characterize air quality using either
appropriately sited ambient air quality monitors or using modeling of
actual or allowable source emissions. The EPA's non-binding Monitoring
Technical Assistance Document (TAD) and Modeling TAD contain
scientifically sound recommendations on how air agencies should conduct
such monitoring or modeling. For the SO2 designations of the
four Texas areas addressed in this supplemental action, the EPA is
using the same approach taken for a number of areas designated in the
final rule signed on June 30, 2016, and considering available air
quality monitoring data from calendar years 2012-2015, and modeling
submitted by the affected emissions sources and a public interest
group. See 81 FR 45043. In the modeling runs, the impacts of the actual
emissions for the 3-year periods 2012-2014 or 2013-2015 were
considered. The 1-hour primary SO2 standard is violated at
an ambient air quality monitoring site (or in the case of dispersion
modeling, at an ambient air quality receptor location) when the 3-year
average of the annual 99th percentile of the daily maximum 1-hour
average concentrations exceeds 75 ppb, as determined in accordance with
appendix T of 40 CFR part 50. The EPA has concluded that dispersion
modeling shows that three Round 2 areas in Texas (portions of Freestone
and Anderson Counties, portions of Rusk and Panola Counties, and
portions of Titus County) are not meeting the 1-hour primary
SO2 standard and we are, therefore, designating these areas
as nonattainment. Based on available information, the EPA has also
concluded that it cannot determine whether one Round 2 area in Texas
(Milam County) is or is not meeting the 1-hour primary SO2
standard and whether the area contributes to a violation in a nearby
area. Therefore, we are designating this area as unclassifiable.
Details about the available information can be found in the
supplemental technical support document in the docket for the Round 2
SO2 designations at Docket ID No. EPA-HQ-OAR-2014-0464.

VII. How do the designations supplementing the Round 2 designations
affect Indian country?

    For the designations in four areas of Texas for the 2010 primary
SO2 NAAQS supplementing the Round 2 designations, the EPA is
designating 3 state areas as nonattainment and 1 state area as
unclassifiable. No areas of Indian country are being designated as part
of this action.

VIII. Where can I find information forming the basis for this action
and exchanges between the EPA, states and tribes related to this
action?

    Information providing the basis for this action can be found in
several technical support documents (TSDs), a response to comments
document (RTC) and other information in the docket. The TSDs, RTC,
applicable EPA guidance memoranda and copies of correspondence
regarding this process between the EPA and the states, tribes and other
parties, are available for review at the EPA Docket Center listed above
in the ADDRESSES section of this document and on the agency's
SO2 Designations Web site at https://www.epa.gov/sulfur-dioxide-designations. Area-specific questions can be addressed by the
EPA Regional office (see contact information provided at the beginning
of this notice).

IX. Environmental Justice Concerns

    When the EPA establishes a new or revised NAAQS, the CAA requires
the EPA to designate all areas of the U.S. as either nonattainment,
attainment, or unclassifiable. This final action addresses designation
determinations for four areas in Texas for the 2010 primary
SO2 NAAQS. Area designations address environmental justice
concerns by ensuring that the public is properly informed about the air
quality in an area. In locations where air quality does not meet the
NAAQS, the CAA requires relevant state authorities to initiate
appropriate air quality management actions to ensure that all those
residing, working, attending school, or otherwise present in those
areas are protected, regardless of minority and economic status.

X. Statutory and Executive Order Reviews

    Upon promulgation of a new or revised NAAQS, the CAA requires the
EPA to designate areas as attaining or not attaining the NAAQS. The CAA
then specifies requirements for areas based on whether such areas are
attaining or not attaining the NAAQS. In this final rule, the EPA
assigns designations to selected areas as required.

A. Executive Order 12866: Regulatory Planning and Review and Executive
Order 13563: Improving Regulation and Regulatory Review

    This action is exempted from the Office of Management and Budget
because it responds to the CAA requirement to promulgate air quality
designations after promulgation of a new or revised NAAQS.

B. Paperwork Reduction Act (PRA)

    This action does not impose an information collection burden under
the PRA. This action responds to the requirement to promulgate air
quality designations after promulgation of a new or revised NAAQS. This
requirement is prescribed in the CAA section 107 of title 1. This
action does not contain any information collection activities.

C. Regulatory Flexibility Act (RFA)

    This final rule is not subject to the RFA. The RFA applies only to
rules subject to notice-and-comment rulemaking requirements under the
Administrative Procedure Act (APA), 5 U.S.C. 553, or any other statute.
This rule is not subject to notice-and-comment requirements under the
APA but is subject to the CAA section 107(d)(2)(B) which does not
require a notice-and-comment rulemaking to take this action.

D. Unfunded Mandates Reform Act (UMRA)

    This action does not contain any unfunded mandates as described by
URM, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect
small governments. The action imposes no enforceable duty on any state,
local or tribal governments or the private sector.

E. Executive Order 13132: Federalism

    This final action does not have federalism implications. It will
not have substantial direct effects on the states, on the relationship
between the national government and the states or on the distribution
of power and responsibilities among the various levels of government.

F. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments

    This action does not have tribal implications, as specified in
Executive Order 13175. This action concerns the designation of certain
areas in the U.S. for the 2010 primary SO2 NAAQS. The CAA
provides for states and eligible tribes to develop plans to regulate
emissions of air pollutants within their areas, as necessary, based on
the designations. The Tribal Authority Rule (TAR) provides tribes the
opportunity to apply for eligibility to develop and implement CAA
programs, such as programs to attain and maintain the SO2
NAAQS, but it leaves to the discretion of the tribe the decision of
whether to apply to develop these programs and which programs, or
appropriate elements of a program, the tribe will seek to adopt. This
rule does not have a substantial direct effect on one or more Indian
tribes. It does not create any additional requirements beyond those of
the SO2 NAAQS. This rule establishes the designations for
certain areas of the country for the SO2 NAAQS, but no areas
of Indian country are being designated in this action. Furthermore,
this rule does not affect the relationship or distribution of power and
responsibilities between the federal government and Indian tribes. The
CAA and the TAR establish the relationship of the federal government
and tribes in developing plans to attain the NAAQS, and this rule does
nothing to modify that relationship. Thus, Executive Order 13175 does
not apply.
    Although Executive Order 13175 does not apply to this rule, after
the EPA promulgated the 2010 primary SO2 NAAQS, the EPA
communicated with tribal leaders and environmental staff regarding the
designations process. The EPA also sent individualized letters to all
federally recognized tribes to explain the designation process for the
2010 primary SO2 NAAQS, to provide the EPA designations
guidance, and to offer consultation with the EPA. The EPA provided
further information to tribes through presentations at the National
Tribal Forum and through participation in National Tribal Air
Association conference calls. The EPA also sent individualized letters
to all federally recognized tribes that submitted recommendations to
the EPA about the EPA's intended designations for the SO2
standard and offered tribal leaders the opportunity for consultation.
These communications provided opportunities for tribes to voice
concerns to the EPA about the general designations process for the 2010
primary SO2 NAAQS, as well as concerns specific to a tribe,
and informed the EPA about key tribal concerns regarding designations
as the rule was under development. For this supplemental round of
SO2 designations action, the EPA sent additional letters to
tribes that could potentially be affected and offered additional
opportunities for participation in the designations process. The
communication letters to the tribes are provided in the dockets for
Round 1 designations (Docket ID No. EPA-HQ-OAR-2012-0233) and Round 2
designations (Docket ID No. EPA-HQ-OAR-2014-0464).

G. Executive Order 13045: Protection of Children From Environmental
Health Risks and Safety Risks

    The action is not subject to Executive Order 13045 because it is
not an economically significant regulatory action as defined in
Executive Order 12866. While not subject to the Executive Order, this
final action may be especially important for asthmatics, including
asthmatic children, living in SO2 nonattainment areas
because respiratory effects in asthmatics are among the most sensitive
health endpoints for SO2 exposure. Because asthmatic
children are considered a sensitive population, the EPA evaluated the
potential health effects of exposure to SO2 pollution among
asthmatic children as part of the EPA's prior action establishing the
2010 primary SO2 NAAQS. These effects and the size of the
population affected are summarized in the EPA's final SO2
NAAQS rules. See http://www3.epa.gov/ttn/naaqs/standards/so2/fr/20100622.pdf.

H. Executive Order 13211: Actions That Significantly Affect Energy
Supply, Distribution, or Use

    This action is not subject to Executive Order 13211, because it is
not a significant regulatory action under Executive Order 12866.

I. National Technology Transfer and Advancement Act (NTTAA)

    This action does not involve technical standards.

J. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations

    The EPA believes this action does not have disproportionately high
and adverse human health or environmental effects on minority
populations, low-income populations and or indigenous peoples, as
specified Executive Order 12898 (59 FR 7629, February 16, 1994). The
documentation for this decision is contained in Section IX of this
document.

K. Congressional Review Act (CRA)

    The CRA, 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 U.S. The 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 U.S. 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). This rule will be effective
January 12, 2017.

L. Judicial Review

    Section 307 (b) (1) of the CAA indicates which Federal Courts of
Appeal have venue for petitions for review of final actions by the EPA.
This section provides, in part, that petitions for review must be filed
in the Court of Appeals for the District of Columbia Circuit: (i) When
the agency action consists of ``nationally applicable

regulations promulgated, or final actions taken, by the
Administrator,'' or (ii) when such action is locally or regionally
applicable, if ``such action is based on a determination of nationwide
scope or effect and if in taking such action the Administrator finds
and publishes that such action is based on such a determination.''
    This final action designating areas for the 2010 primary
SO2 NAAQS is ``nationally applicable'' within the meaning of
section 307(b)(1). As explained in the preamble, this final action
supplements the June 30, 2016 final action taken by the EPA to issue a
second round of designations for areas across the U.S. for the 2010
primary SO2 NAAQS. EPA determined the June 30, 2016 final
action was ``nationally applicable'' within the meaning of section
307(b)(1). 81 FR 45045. The rulemaking docket, EPA-HQ-OAR-2014-0464, is
the same docket for both the June 30, 2016 action and for this
supplemental action, with the relevant difference being that in
addition to the materials it contained regarding these four Texas areas
generated through June 30, 2016--the date that action was signed by the
Administrator--it now also contains the final technical support
documents and responses to comments related to these four areas. Both
the June 30, 2016 action and this supplemental action were proposed in
a single March 1, 2016, notice announcing the EPA's intended Round 2
designations and were taken to discharge a duty under the court order
to issue a round of designations of areas with sources meeting common
criteria in the court order. As explained in the June 30, 2016 final
rule, at the core of that final action and this supplemental final
action is the EPA's interpretation of the definitions of nonattainment,
attainment and unclassifiable under section 107(d)(1) of the CAA, and
its application of that interpretation to areas across the country. Id.
Accordingly, the Administrator has determined that this supplemental
final action, which results from the same proposed action as the June
30, 2016 final action, is nationally applicable and is hereby
publishing that finding in the Federal Register.
    For the same reasons, the Administrator also is finding that this
supplemental final action is based on a determination of nationwide
scope and effect for the purposes of section 307(b)(1). As previously
explained in the June 30, 2016 final action, in the report on the 1977
Amendments that revised section 307(b)(1) of the CAA, Congress noted
that the Administrator's determination that an action is of
``nationwide scope or effect'' would be appropriate for any action that
has a scope or effect beyond a single judicial circuit. H.R. Rep. No.
95-294 at 323, 324, reprinted in 1977 U.S.C.C.A.N. 1402-03. 81 FR
45045. Here, the June 30, 2016 final action and this supplemental final
action combined issue designations in 65 areas in 24 states and extend
to numerous judicial circuits. In these circumstances, section
307(b)(1) and its legislative history calls for the Administrator to
find the action to be of ``nationwide scope or effect'' and for venue
to be in the D.C. Circuit. Therefore, like the June 30, 2016 final
action it supplements, see 81 FR at 45045, this final action is based
on a determination by the Administrator of nationwide scope or effect,
and the Administrator is hereby publishing that finding in the Federal
Register.
    Thus, any petitions for review of these final designations must be
filed in the Court of Appeals for the District of Columbia Circuit
within 60 days from the date final action is published in the Federal
Register.

List of Subjects in 40 CFR Part 81

    Environmental protection, Air pollution control, National parks,
Wilderness areas.

    Dated: November 29, 2016.
Gina McCarthy,
Administrator.

    For the reasons set forth in the preamble, 40 CFR part 81 is
amended as follows:

PART 81--DESIGNATIONS OF AREAS FOR AIR QUALITY PLANNING PURPOSES

0
1. The authority citation for part 81 continues to read as follows:

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

Subpart C--Section 107 Attainment Status Designations

0
2. Section 81.344 is amended by revising the table titled ``Texas--2010
Sulfur Dioxide NAAQS (Primary)'' to read as follows:

Sec.  81.344   Texas.

* * * * *

                                   Texas--2010 Sulfur Dioxide NAAQS (Primary)
----------------------------------------------------------------------------------------------------------------
                                                                               Designation
                    Designated area                     --------------------------------------------------------
                                                              Date                         Type
----------------------------------------------------------------------------------------------------------------
Freestone and Anderson Counties, TX \1\................         1/12/17  Nonattainment.
    Freestone County (part) and Anderson County (part)                   .......................................
        Those portions of Freestone and Anderson                         .......................................
         Counties encompassed by the rectangle with the
         vertices using Universal Traverse Mercator
         (UTM) coordinates in UTM zone 14 with datum
         NAD83 as follows:
            (1) Vertices--UTM Easting (m) 766752.69,                     .......................................
             UTM Northing (m) 3536333.0,
            (2) vertices--UTM Easting (m) 784752.69,                     .......................................
             UTM Northing (m) 3536333.0,
            (3) vertices--UTM Easting (m) 784752.69,                     .......................................
             UTM Northing (m) 3512333.0,
            (4) vertices--UTM Easting (m) 766752.69,                     .......................................
             UTM Northing (m) 3512333.0
Rusk and Panola Counties, TX \1\.......................         1/12/17  Nonattainment.
    Rusk County (part) and Panola County (part)                          .......................................
        Those portions of Rusk and Panola Counties                       .......................................
         encompassed by the rectangle with the vertices
         using Universal Traverse Mercator (UTM)
         coordinates in UTM zone 15 with datum NAD83 as
         follows:
            (1) Vertices--UTM Easting (m) 340067.31,                     .......................................
             UTM Northing (m) 3575814.75
            (2) vertices--UTM Easting (m) 356767.31,                     .......................................
             UTM Northing (m) 3575814.75
            (3) vertices--UTM Easting (m) 356767.31,                     .......................................
             UTM Northing (m) 3564314.75
            (4) vertices--UTM Easting (m) 340067.31,                     .......................................
             UTM Northing (m) 3564314.75
Titus County, TX \1\...................................         1/12/17  Nonattainment.
    Titus County (part)                                                  .......................................
        That portion of Titus County encompassed by the                  .......................................
         rectangle with the vertices using Universal
         Traverse Mercator (UTM) coordinates in UTM
         zone 15 with datum NAD83 as follows:

            (1) Vertices--UTM Easting (m) 304329.030,                    .......................................
             UTM Northing (m) 3666971.0,
            (2) vertices--UTM Easting (m) 311629.030,                    .......................................
             UTM Northing (m) 3666971.0,
            (3) vertices--UTM Easting (m) 311629.03,                     .......................................
             UTM Northing (m) 3661870.5,
            (4) vertices--UTM Easting (m) 304329.03,                     .......................................
             UTM Northing (m) 3661870.5
Milam County, TX \1\...................................         1/12/17  Unclassifiable.
    Milam County, TX                                                     .......................................
Potter County, TX \ 1\.................................         9/12/16  Unclassifiable.
    Potter County, TX                                                    .......................................
Atascosa County, TX \1\................................         9/12/16  Unclassifiable/Attainment.
    Atascosa County, TX                                                  .......................................
Fort Bend County, TX \1\...............................         9/12/16  Unclassifiable/Attainment.
    Fort Bend County                                                     .......................................
Goliad County, TX \1\..................................         9/12/16  Unclassifiable/Attainment.
    Goliad County                                                        .......................................
Lamb County, TX \1\....................................         9/12/16  Unclassifiable/Attainment.
    Lamb County                                                          .......................................
Limestone County, TX \2\...............................         9/12/16  Unclassifiable/Attainment.
    Limestone County                                                     .......................................
McLennan County, TX \2\................................         9/12/16  Unclassifiable/Attainment.
    McLennan County, TX                                                  .......................................
Robertson County, TX \2\...............................         9/12/16  Unclassifiable/Attainment.
    Robertson County                                                     .......................................
----------------------------------------------------------------------------------------------------------------
\1\ Excludes Indian country located in each area, if any, unless otherwise specified.
\2\ Includes Indian country located in each area, if any, unless otherwise specified.

* * * * *
[FR Doc. 2016-29561 Filed 12-12-16; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 85, Number 58 (Wednesday, March 25, 2020)]
[Notices]
[Pages 16978-16981]
[FR Doc No: 2020-06190]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-88426; File No. SR-CBOE-2020-021]

Self-Regulatory Organizations; Cboe Exchange, Inc.; Notice of
Filing and Immediate Effectiveness of a Proposed Rule Change To Amend
Its Fees Schedule

March 19, 2020.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on March 17, 2020, Cboe Exchange, Inc. (the ``Exchange'' or ``Cboe
Options'') filed with the Securities and Exchange Commission (the
``Commission'') the proposed rule change as described in Items I, II,
and III below, which Items have been prepared by the Exchange. The
Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
---------------------------------------------------------------------------

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

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

    Cboe Exchange, Inc. (the ``Exchange'' or ``Cboe Options'') proposes
to amend its Fees Schedule. The text of the proposed rule change is
provided in Exhibit 5.
    The text of the proposed rule change is also available on the
Exchange's website (http://www.cboe.com/AboutCBOE/CBOELegalRegulatoryHome.aspx), at the Exchange's Office of the
Secretary, and at the Commission's Public Reference Room.

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

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

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

1. Purpose
    The Exchange proposes to adopt new Footnote 12 of the Fees Schedule
to govern pricing changes in the event the Exchange trading floor
becomes inoperable.\3\ In the event the trading floor becomes
inoperable, the Exchange will continue to operate in a screen-based
only environment using a floorless configuration of the System that is
operational while the trading floor facility is inoperable. The
Exchange would operate using that configuration only until the
Exchange's trading floor facility became operational. Open outcry
trading would not be available in the event the trading floor becomes
inoperable.
---------------------------------------------------------------------------

    \3\ The Exchange originally submitted the proposed fee changes
on March 16, 2020 (SR-CBOE-2020-020). On March 17, 2020, the
Exchange withdrew that filing and submitted this filing.
---------------------------------------------------------------------------

    The Exchange first proposes to provide that in the event the Cboe
Options trading floor becomes inoperable, holders of a Market-Maker
Floor Permit will be entitled to act as an electronic Market-Maker and
holders of a Floor Broker Permit will be entitled to access the
Exchange electronically to submit orders to the Exchange, at no further
cost. Currently, in order to act as a Market-Maker electronically a
Trading Permit Holder (``TPH'') must purchase a Market-Maker Electronic
Access Permit. In order to access the Exchange electronically and
submit orders to the Exchange, a TPH must purchase an ``Electronic
Access Permit''. Conversely, TPHs that wish to act as a Market-Maker on
the floor must purchase a Market-Maker Permit and TPHs that wish to act
as a Floor Broker on the floor of the Exchange must purchase a Floor
Broker Permit. The Exchange wishes to encourage floor-based market
participants to participate on the Exchange electronically if the
trading floor becomes inoperable. As such, the Exchange proposes to
provide that holders of a Market-Maker Floor Permit and Floor Broker
Permit are entitled to operate electronically in their registered
capacity at no additional cost (i.e., not charge for an additional
Market-Maker Electronic Access Permit or Electronic Access Permit).
    The Exchange next proposes to amend the Floor Broker ADV Discount.
Under this discount program, Floor Broker Trading Permit fees are
eligible for rebates based on the average customer (``C'') open-outcry
contracts executed per day over the course of a calendar month in all
underlying symbols. In light of the Exchange's recent announcement that
it's trading floor would be considered inoperable starting March 16,
2020, the Exchange proposes to provide that for the month of March
2020, ADV will be based on March 1-March 13, 2020 volume.
    The Exchange next proposes to provide that in the event the trading
floor becomes inoperable, the Exchange shall waive SPX and SPXW
Execution Surcharges for SPX and SPXW volume executed via the Automated
Improvement Mechanism (``AIM'') for the duration of time the Exchange
operates in a screen-based only environment. The Exchange currently
assesses a SPX Execution Surcharge of $0.21 per contract and a SPXW
Execution Surcharge of $0.13 per contract for non-Market Maker orders
in SPX and SPXW, respectively that are executed electronically (with
some exceptions).\4\ The Execution Surcharges were adopted to ensure
that there is reasonable cost equivalence between the primary execution
channels for SPX and SPXW. More specifically, the Execution Surcharges
minimize the cost differentials between manual and electronic
executions, which is in the interest of the Exchange as it must both
maintain robust electronic systems as well as provide for economic
opportunity for floor brokers to continue to conduct business, as the
Exchange believes they serve an important function in achieving price
discovery and customer executions.\5\ In the event the trading floor
becomes inoperable, the only execution available for SPX and SPXW would
be electronic executions. The Exchange still wishes to encourage floor
brokers to continue to conduct business on the Exchange, albeit
electronically when the floor is inoperable. To that end, in order to
approximate the trading floor environment electronically, the Exchange
will make AIM available for SPX/SPXW in the event the trading floor
becomes inoperable. Particularly, the Exchange notes that it can
determine AIM eligibility on a class-by-class basis \6\ and
historically SPX and SPXW have not been designated as eligible for AIM
Auctions. As such, the Exchange does not wish to discourage floor
brokers from executing SPX and SPXW volume via AIM when the trading
floor is inoperable by assessing the Execution

Surcharges such volume. Indeed, in the absence of the trading floor
being inoperable, AIM would not be available for SPX/SPX and such
volume would otherwise execute on the floor and not be subject to the
Execution Surcharges.
---------------------------------------------------------------------------

    \4\ See Cboe Options Fees Schedule, Footnote 21.
    \5\ See e.g., Securities Exchange Act Release No. 71295 (January
14, 2014) 79 FR 3443 (January 21, 2014) (SR-CBOE-2013-129).
    \6\ See Rule 5.37(a)(1) and 5.38(a)(1).
---------------------------------------------------------------------------

    The Exchange next proposes to adopt an AIM Execution Surcharge for
SPX, SPXW and VIX AIM Agency/Primary orders for all market participants
which would apply only when the Exchange operates in a screen-based
only environment and which would be invoiced to the executing TPH.
Specifically, the Exchange proposes to adopt a $0.05 per contract fee
for SPX and SPXW AIM Agency/Primary orders and a $0.04 per contract fee
for VIX AIM Agency/Primary orders. The Exchange notes that currently,
SPX, SPXW and VIX orders executed via open-outcry are assessed floor
brokerage fees. Specifically, SPX/SPXW orders are assessed a floor
brokerage fee of $0.04 per contract fee for non-crossed orders and a
$0.02 per contract fee for crossed orders and VIX orders are assessed a
floor brokerage fee of $0.03 per contract for non-crossed orders and
$0.015 per contract for crossed orders. The Exchange notes that in the
event the trading floor becomes inoperable, volume that would otherwise
be executed on the floor would have to be executed electronically. The
Exchange believes it's appropriate to continue to assess this volume,
notwithstanding the fact that it is being moved to an electronic
channel.
    The Exchange also proposes to provide that SPX/SPXW, VIX and RUT
contracts executed via AIM during the time when the Exchange operates
in a screen-based only environment will not count towards the 1,000
contract thresholds for the electronic SPX/SPXW, VIX and RUT Tier
Appointment Fee. Currently, the Exchange assesses separate monthly Tier
Appointment Fees to electronic and floor Market-Maker holding a Market-
Maker Electronic Access Permit or Market-Maker Floor Permit,
respectively, that trade SPX (including SPXW), VIX or RUT contracts at
any time during the month. The Exchange proposes to exclude SPX/SPXW,
VIX and RUT volume executed via AIM during the time when the Exchange
operates in a screen-based only environment, as the Exchange does not
wish to discourage the sending of such orders via AIM during that time.
The Exchange notes that the electronic Tier Appointment fees are
intended to be assessed to Market-Maker TPHs who act as Market-Makers
electronically and engage in trading of these products (as opposed to
those who normally execute volume via open outcry, but must participate
electronically due to the trading floor being inoperable).
    The Exchange next proposes to provide that for purposes of the
Market-Maker EAP Appointments Sliding Scale, the total quantity will be
determined by the highest quantity used at any point during the month,
excluding additional quantity added during the time the Exchange
operates in a screen-based only environment. Currently, during Regular
Trading Hours, a Market-Maker has an appointment to trade open outcry
in all classes traded on the Exchange, at no charge.\7\ Electronic
Market-Makers however, must select appointments and are charged for one
or more ``Appointment Units'' (which are scaled from 1 ``unit'' to more
than 5 ``units''), depending on which classes they elect appointments
in.\8\ The Exchange does not wish to subject Market-Makers to increased
fees as a result of selecting appointments to trade electronically in
classes during a time when the Exchange operates in a screen-based only
environment that they otherwise trade, at no charge, on the floor.
---------------------------------------------------------------------------

    \7\ See Rule 5.50(e).
    \8\ Appointment weights for each appointed class are set forth
in Cboe Options Rule 5.50(g) and are summed for each Market-Maker in
order to determine the total appointment units, to which fees will
be assessed.
---------------------------------------------------------------------------

    Lastly, as noted above, SPX and SPXW have not historically been
designated as eligible for AIM Auctions. The Exchange anticipates that
it will designate SPX/SPXW as eligible for AIM Auctions in the event
the trading floor becomes inoperable. The header relating to AIM in the
Rate Table for Underlying Symbol List A Schedule however references
only that AIM is available for (1) VIX and (2) SPX/SPXW during Global
Trading Hours.\9\ As such, the Exchange proposes to clarify in proposed
Footnote 12 of the Fees Schedule that AIM would be available for SPX/
SPXW during Regular Trading Hours, in the event the trading floor is
inoperable.
---------------------------------------------------------------------------

    \9\ See Cboe Options Fees Schedule, Rate Table--Underlying
Symbol List A.
---------------------------------------------------------------------------

2. Statutory Basis
    The Exchange believes the proposed rule change is consistent with
the Securities Exchange Act of 1934 (the ``Act'') and the rules and
regulations thereunder applicable to the Exchange and, in particular,
the requirements of Section 6(b) of the Act. Specifically, the Exchange
believes the proposed rule change is consistent with the Section
6(b)(5) requirements that the rules of an exchange be 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 mechanism of a
free and open market and a national market system, and, in general, to
protect investors and the public interest. Additionally, the Exchange
believes the proposed rule change is consistent with Section 6(b)(4) of
the Act, which requires that Exchange rules provide for the equitable
allocation of reasonable dues, fees, and other charges among its
Trading Permit Holders and other persons using its facilities.
    The Exchange believes the proposed rule change to allow holders of
Floor Trading Permits to operate in their registered capacity
electronically at no further cost is reasonable as such market
participants would not be subject to additional costs in the event they
can only participate electronically due to the trading floor being
inoperable. Indeed, in such an event, the Exchange wishes to encourage
floor-based market participants to continue to participate on the
Exchange electronically. The Exchange believes the proposed rule change
is equitable and not unfairly discriminatory as all such floor
participants will be treated equally. The Exchange also believes it's
proposal to base the ADV thresholds for the Floor Broker ADV Discount
program on volume from March 1, through March 13, 2020 is reasonable as
such discount is based on open-outcry volume only and the Exchange
floor has been closed indefinitely as of March 16, 2020.
    The Exchange believes the proposed rule change to waive SPX and
SPXW Execution Surcharges for AIM volume in the event the trading floor
becomes inoperable is reasonable because market participants will not
be subject to these extra surcharge for these executions. As noted
above, the Execution Surcharges minimize the cost differentials between
manual and electronic executions, which is in the interest of the
Exchange as it must both maintain robust electronic systems as well as
provide for economic opportunity for floor brokers to continue to
conduct business, as the Exchange believes they serve an important
function in achieving price discovery and customer executions. In the
event the trading floor becomes inoperable, Exchange still wishes to
incentivize floor brokers to conduct business on the Exchange, albeit
electronically and as such does not wish to assess a surcharge on
volume that was otherwise executed on floor and not

via AIM. As discussed above, the Exchange wishes to make AIM available
for SPX/SPXW in the event the trading floor is inoperable in order to
best approximate the trading floor in an electronic environment.
Indeed, the Exchange believes waiving the Execution Surcharges for
volume executed via AIM in the event the trading floor is inoperable
will promote and encourage trading of these products notwithstanding
the fact that manual executions are no longer available. Additionally,
the Exchange does not wish to assess the Execution Surcharges on AIM
volume as AIM provides price improvement opportunities for these
orders, similar to the opportunities that are generally available to
them on the trading floor, which protects customers seeking execution
of these orders. The Exchange believes the proposed change is also
equitable and not unfairly discriminatory as it applies uniformly to
all similarly situated market participants, as all TPHs will be able to
execute electronically via AIM and be subject to equivalent execution
costs while the trading floor is inoperable.
    The Exchange believes the proposal to adopt an AIM Execution
Surcharge for SPX/SPXW and VIX Agency/Primary orders is reasonable as
the proposed rates are similar to the total rates charged for volume
that is executed via open-outcry.\10\ The Exchange also notes that the
Fees Schedule already provides for a similar scenario of such rates
being assessed in the event the trading floor is inoperable. For
example, Footnote 15 of the Fees Schedule provides that in the event
the Exchange's exclusively listed options must be traded at a Back-up
Exchange pursuant to Cboe Options Rule 5.26, the Back-up Exchange has
agreed to apply the per contract and per contract side fees (i.e., the
Floor Brokerage fees) to such transactions. Accordingly, the Exchange
believes it's similarly appropriate to adopt and apply similar fees to
transactions that must occur via an electronic execution channel
(instead of on a Back-Up Exchange) due to the Exchange's trading floor
being inoperable. The Exchange also notes that as discussed above, it
is not otherwise assessing the SPX/SPXW Execution Surcharges on AIM
SPX/SPXW orders. The Exchange believes the proposed change is also
equitable and not unfairly discriminatory as it applies uniformly to
all similarly situated market participants, as all TPHs will be able to
execute electronically via AIM and be subject to equivalent execution
costs while the trading floor is inoperable.
---------------------------------------------------------------------------

    \10\ See Cboe Options Fees Schedule, Floor Brokerage Fees.
---------------------------------------------------------------------------

    The Exchange believes its proposal to provide that SPX/SPXW, VIX
and RUT contracts executed via AIM during a time when the Exchange
operates in a screen-based only environment will not count towards the
1,000 contract thresholds for the electronic SPX/SPXW, VIX and RUT Tier
Appointment Fees is reasonable as Market-Makers that would otherwise
meet the current contract thresholds due to the need to participate on
the Exchange electronically will not be subject to an additional Tier
Appointment Fee for volume executed via AIM. The Exchange believes the
proposed change is reasonable as the Tier Appointment fees were
intended to apply to TPHs who act as electronic Market-Makers in SPX/
SPX, VIX and RUT, not those that notwithstanding the trading floor
being inoperable would act as floor Market-Makers and trade these
products. The Exchange anticipates Market-Maker a large portion of
volume for any Market-Maker that trades in SPX/SPXW, VIX and RUT only
in open cry will be executed via AIM in the event the trading floor is
inoperable. Accordingly, the Exchange does not wish to assess the Tier
Appointment fees to Market-Makers who do not usually conduct
significant electronic volume in these products and would not
participate electronically if not for the trading floor being
inoperable. Additionally, the Exchange does not wish to discourage the
use of AIM for SPX/SPXW, VIX or RUT as AIM provides price improvement
opportunities for these orders, similar to the opportunities that are
generally available to them on the trading floor, which protects
customers seeking execution of these orders. The proposed change is
equitable and not unfairly discriminatory because it will apply
uniformly to all similarly situated market participants, as it applies
to all Market-Makers trading in these products.
    The Exchange believes the proposal to not count Appointment Units
added during a time when the Exchange operates in a screen-based only
environment toward the total quantity of Appointment Units for purposes
of calculating the Market-Maker EAP Appointments Sliding Scale is
reasonable, as Market-Makers should not be subject to additional
charges resulting from any additional appointments selected during a
time when the trading floor is inoperable. As discussed above, floor
Market-Makers have an appointment to trade open outcry in all classes
traded on the Exchange at no cost. The Exchange does not wish to
subject Market-Makers to increased fees as a result of selecting
appointments to trade classes electronically during a time when the
trading floor is inoperable, particularly classes they would otherwise
trade at no charge on the trading floor. The proposed change is
equitable and not unfairly discriminatory because it will apply
uniformly to all similarly situated market participants, as it will
apply to all Market-Makers, while also ensuring that Market-Makers who
generally operate on the trading floor will not be subject to
additional costs due to the unavailability of the trading floor.
    Lastly, the Exchange believes its proposal to clarify in the fees
schedule that AIM may be available for SPX/SPXW during Regular Trading
Hours in the even the trading floor becomes inoperable will provide
clarity in the Fees Schedule and alleviate potential confusion, thereby
removing impediments to and perfecting the mechanism of a free and open
market and a national market system, and, in general, protecting
investors and the public interest.

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

    The Exchange does not believe that the proposed rule changes will
impose any burden on competition that are not necessary or appropriate
in furtherance of the purposes of the Act. The Exchange notes the
proposed changes are not intended to address any competitive issue, but
rather to address fee changes it believes are reasonable in the event
the trading floor becomes inoperable, thereby only permitting
electronic participation on the Exchange. The Exchange does not believe
that the proposed rule change will impose any burden on intramarket
competition that is not necessary or appropriate in furtherance of the
purposes of the Act because the proposed changes apply equally to all
similarly situated market participants. The Exchange does not believe
that the proposed rule changes will impose any burden on intermarket
competition that is not necessary or appropriate in furtherance of the
purposes of the Act because the proposed changes only affect trading on
the Exchange in limited circumstances.

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

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

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A) of the Act \11\ and paragraph (f) of Rule 19b-4 \12\
thereunder. At any time within 60 days of the filing of the proposed
rule change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission will institute proceedings to
determine whether the proposed rule change should be approved or
disapproved.
---------------------------------------------------------------------------

    \11\ 15 U.S.C. 78s(b)(3)(A).
    \12\ 17 CFR 240.19b-4(f).
---------------------------------------------------------------------------

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-CBOE-2020-021 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-CBOE-2020-021. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (http://www.sec.gov/rules/sro.shtml).
Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for website viewing and printing in
the Commission's Public Reference Room, 100 F Street NE, Washington, DC
20549, on official business days between the hours of 10:00 a.m. and
3:00 p.m. Copies of the filing also will be available for inspection
and copying at the principal office of the Exchange. All comments
received will be posted without change. Persons submitting comments are
cautioned that we do not redact or edit personal identifying
information from comment submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File Number SR-CBOE-2020-021 and should be submitted on
or before April 15, 2020.

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

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

J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2020-06190 Filed 3-24-20; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 88, Number 135 (Monday, July 17, 2023)]
[Notices]
[Pages 45431-45432]
[FR Doc No: 2023-15045]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-2562]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Temporary Marketing Permit Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information, and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on reporting requirements contained in
existing FDA regulations governing temporary marketing permit
applications.

DATES: Either electronic or written comments on the collection of
information must be submitted by September 15, 2023.

ADDRESSES: 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 at the end of September 15, 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-2023-N-2562 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Temporary Marketing Permit
Applications.'' 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: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601

Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Temporary Marketing Permit Applications--21 CFR 130.17(c) and (i)

OMB Control Number 0910-0133--Extension

    This information collection request supports FDA regulations found
in 21 CFR 130.17 (section 130.17). Section 401 of the Federal Food,
Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 341) directs FDA to
issue regulations establishing definitions and standards of identity
(SOIs) for food. Under section 403(g) of the FD&C Act (21 U.S.C.
343(g)), a food that is subject to a definition and SOI prescribed by
regulation is misbranded if it does not conform to such definition and
SOI. Section 130.17 provides for the issuance by FDA of temporary
marketing permits (TMPs) that enable the food industry to test consumer
acceptance and measure the technological and commercial feasibility in
interstate commerce of experimental packs of food that deviate from
applicable definitions and SOIs. Section 130.17(c) enables the Agency
to monitor the manufacture, labeling, and distribution of experimental
packs of food that deviate from applicable definitions and SOIs. The
information so obtained can be used in support of a petition to
establish or amend the applicable definition or SOI to provide for the
variations. Section 130.17(i) specifies the information that a firm
must submit to FDA to obtain an extension of a TMP. To assist
respondents with the TMP process, we have developed guidance entitled
``Temporary Permits for Interstate Shipment of Experimental Packs of
Food Varying from the Requirements of Definitions and Standards of
Identity: Guidance for Industry'' (November 2021). This resource can be
found on our website https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-temporary-permits-interstate-shipment-experimental-packs-food-varying-requirements.
    Description of Respondents: Respondents to this collection of
information include private sector businesses including institutional
and/or industrial customers and food industry members such as
manufacturers, packers, or distributors desiring to apply for a TMP or
TMP extension.
    We estimate the burden of this collection of information as
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of
    21 CFR section; activity         Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
----------------------------------------------------------------------------------------------------------------
130.17(c); Request for TMP......              13               2              26              25             650
130.17(i); Request for TMP                     1               2               2               2               4
 extension......................
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............             654
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Based on a review of the information collection since our last
request for OMB approval, we have made no adjustments to our burden
estimate.

    Dated: July 12, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-15045 Filed 7-14-23; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 81, Number 73 (Friday, April 15, 2016)]
[Notices]
[Pages 22277-22278]
[FR Doc No: 2016-08685]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0893]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Center for Devices
and Radiological Health Appeals Processes

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by May 16,
2016.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX:<PHONE_NUMBER>, or emailed to<EMAIL_ADDRESS>All
comments should be identified with the OMB control number 0910-0738.
Also include the FDA docket number found in brackets in the heading of
this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Center for Devices and Radiological Health Appeals Processes--

OMB Control Number 0910-0738--Extension

    The guidance document entitled ``Guidance for Industry and Food and
Drug Administration Staff; Center for Devices and Radiological Health
Appeals Processes'' describes the processes available to outside
stakeholders to request additional review of decisions or actions by
Center for Devices and Radiological Health (CDRH) employees. FDA is
seeking approval for the new reporting burden associated with requests
for additional review of decisions and actions by CDRH employees as
described in the guidance.
    Individuals outside of FDA who disagree with a decision or action
taken by CDRH and wish to have it reviewed or reconsidered have several
processes for resolution from which to choose, including: Requests for
supervisory review of an action; petitions; and hearings. Of these, by
far the most commonly used is a request for supervisory review under
Sec.  10.75 (21 CFR 10.75) (a ``10.75 appeal''). Section 517A of the
Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360g-1),
added by section 603 of the Food and Drug Safety and Innovation

Act of 2012, includes new requirements pertaining to the process and
timelines for 10.75 appeals of ``significant decisions'' regarding
510(k) premarket notifications, applications for premarket approvals
(PMAs), and applications for investigational device exemptions (IDEs).
    A request for review under Sec.  10.75 should be based on the
information that was already present in the administrative file at the
time of the decision that is being reviewed as provided in Sec.
10.75(d). New section 517A of the FD&C Act refers to significant
decisions regarding the information in the administrative file for
premarket notifications (section 510(k)); PMAs (section 515); and IDEs
(section 520(g)) submissions is collected under existing regulations
which specify the information manufacturers must submit so that FDA may
properly evaluate the safety and effectiveness of medical devices. The
information collections associated with these regulations are currently
approved by the Office of Management and Budget as follows: The
collections of information in 21 CFR part 807, subpart E (premarket
notification) have been approved under OMB control number 0910-0120;
the collections of information in 21 CFR part 814 (premarket approval)
have been approved under OMB control number 0910-0231; and the
collections of information in 21 CFR part 812 (investigational device
exemption) have been approved under OMB control number 0910-0078.
    While CDRH already possesses in the administrative file the
information that would form the basis of a decision on a matter under
appeal, the submission of particular information regarding the request
itself and the data and information relied on by the requestor in the
appeal would facilitate timely resolution of the decision under review.
The guidance describes the collection of information not expressly
specified under existing regulations such as: The submission of the
request for review, minor clarifications as part of the request, and
supporting information.
    In the Federal Register of October 21, 2015 (80 FR 63804), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of
                              Activity                                  Number of      responses per     Total annual   Average  burden    Total hours
                                                                       respondents       respondent       responses      per  response
--------------------------------------------------------------------------------------------------------------------------------------------------------
CDRH Appeals Processes Guidance Document...........................              50                1               50                8              400
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Dated: April 8, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-08685 Filed 4-14-16; 8:45 am]
 BILLING CODE 4164-01-P