[Federal Register Volume 88, Number 10 (Tuesday, January 17, 2023)]
[Rules and Regulations]
[Pages 2518-2520]
[FR Doc No: 2023-00480]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 862

[Docket No. FDA-2022-N-3335]

Medical Devices; Clinical Chemistry and Clinical Toxicology
Devices; Classification of the Prognostic Test for Assessment of Liver
Related Disease Progression

AGENCY: Food and Drug Administration, HHS.

ACTION: Final amendment; final order.

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

SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
classifying the prognostic test for assessment of liver related disease
progression into class II (special controls). The special controls that
apply to the device type are identified in this order and will be part
of the codified language for the prognostic test for assessment of
liver related disease progression's classification. We are taking this
action because we have determined that classifying the device into
class II (special controls) will provide a reasonable assurance of
safety and effectiveness of the device. We believe this action will
also enhance patients' access to beneficial innovative devices.

DATES: This order is effective January 17, 2023. The classification was
applicable on August 20, 2021.

FOR FURTHER INFORMATION CONTACT: Irene Tebbs, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 3526, Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Upon request, FDA has classified the prognostic test for assessment
of liver related disease progression as class II (special controls),
which we have determined will provide a reasonable assurance of safety
and effectiveness. In addition, we believe this action will enhance
patients' access to beneficial innovation, in part by placing the
device into a lower device class than the automatic class III
assignment.
    The automatic assignment of class III occurs by operation of law
and without any action by FDA, regardless of the level of risk posed by
the new device. Any device that was not in commercial distribution
before May 28, 1976, is automatically classified as, and remains
within, class III and requires premarket approval unless and until FDA
takes an action to classify or reclassify the device (see 21 U.S.C.
360c(f)(1)). We refer to these devices as ``postamendments devices''
because they were not in commercial distribution prior to the date of
enactment of the Medical Device Amendments of 1976, which amended the
Federal Food, Drug, and Cosmetic Act (FD&C Act).
    FDA may take a variety of actions in appropriate circumstances to
classify or reclassify a device into class I or II. We may issue an
order finding a new device to be substantially equivalent under section
513(i) of the FD&C Act (see 21 U.S.C. 360c(i)) to a predicate device
that does not require premarket approval. We determine whether a new
device is substantially equivalent to a predicate device by means of
the procedures for premarket notification under section 510(k) of the
FD&C Act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807).
    FDA may also classify a device through ``De Novo'' classification,
a common name for the process authorized under section 513(f)(2) of the
FD&C Act. Section 207 of the Food and Drug Administration Modernization
Act of 1997 (Pub. L. 105-115) established the first procedure for De
Novo classification. Section 607 of the Food and Drug Administration
Safety and Innovation Act (Pub. L. 112-144) modified the De Novo
application process by adding a second procedure. A device sponsor may
utilize either procedure for De Novo classification.
    Under the first procedure, the person submits a 510(k) for a device
that has not previously been classified. After receiving an order from
FDA classifying the device into class III under section 513(f)(1) of
the FD&C Act, the person then requests a classification under section
513(f)(2).
    Under the second procedure, rather than first submitting a 510(k)
and then a request for classification, if the person determines that
there is no legally marketed device upon which to base a determination
of substantial equivalence, that person requests a classification under
section 513(f)(2) of the FD&C Act.
    Under either procedure for De Novo classification, FDA is required
to classify the device by written order within 120 days. The
classification will be according to the criteria under section
513(a)(1) of the FD&C Act. Although the device was automatically placed
within class III, the De Novo classification is considered to be the
initial classification of the device.
    When FDA classifies a device into class I or II via the De Novo
process, the device can serve as a predicate for future devices of that
type, including for 510(k)s (see section 513(f)(2)(B)(i) of the FD&C
Act). As a result, other device sponsors do not have to submit a De
Novo request or premarket approval application to market a
substantially equivalent device (see section 513(i) of the FD&C Act,
defining ``substantial equivalence''). Instead, sponsors can use the
less-burdensome 510(k) process, when necessary, to market their device.

II. De Novo Classification

    On November 4, 2020, FDA received Siemens Healthcare Diagnostics
Inc.'s request for De Novo classification of the ADVIA Centaur Enhanced
Liver Fibrosis. FDA reviewed the request in order to classify the
device under the

criteria for classification set forth in section 513(a)(1) of the FD&C
Act.
    We classify devices into class II if general controls by themselves
are insufficient to provide reasonable assurance of safety and
effectiveness, but there is sufficient information to establish special
controls that, in combination with the general controls, provide
reasonable assurance of the safety and effectiveness of the device for
its intended use (see 21 U.S.C. 360c(a)(1)(B)). After review of the
information submitted in the request, we determined that the device can
be classified into class II with the establishment of special controls.
FDA has determined that these special controls, in addition to the
general controls, will provide reasonable assurance of the safety and
effectiveness of the device.
    Therefore, on August 20, 2021, FDA issued an order to the requester
classifying the device into class II. In this final order, FDA is
codifying the classification of the device by adding 21 CFR
862.1622.\1\ We have named the generic type of device prognostic test
for assessment of liver related disease progression, and it is
identified as a device intended to measure one or more analytes
obtained from human samples as an aid in assessing progression of liver
related disease. This device is not intended for diagnosis of any
disease, for monitoring the effect of any therapeutic product, for
assessing progression to hepatocellular carcinoma, or for assessing
disease progression in individuals with viral hepatitis. It is also not
intended for the detection of viruses, viral antigens, or antibodies to
viruses.
---------------------------------------------------------------------------

    \1\ FDA notes that the ``ACTION'' caption for this final order
is styled as ``Final amendment; final order,'' rather than ``Final
order.'' Beginning in December 2019, this editorial change was made
to indicate that the document ``amends'' the Code of Federal
Regulations. The change was made in accordance with the Office of
Federal Register's (OFR) interpretations of the Federal Register Act
(44 U.S.C. chapter 15), its implementing regulations (1 CFR 5.9 and
parts 21 and 22), and the Document Drafting Handbook.
---------------------------------------------------------------------------

    FDA has identified the following risks to health associated
specifically with this type of device and the measures required to
mitigate these risks in table 1.

    Table 1--Prognostic Test for Assessment of Liver Related Disease
                Progression Risks and Mitigation Measures
------------------------------------------------------------------------
       Identified risks                   Mitigation measures
------------------------------------------------------------------------
False negative results         Certain design verification and
 leading to delayed             validation activities, including certain
 assessment or treatment.       clinical studies; and
                               Certain labeling information, including
                                certain warnings and performance
                                information.
False positive results         Certain design verification and
 leading to unnecessary         validation activities, including certain
 medical procedures.            clinical studies; and
                               Certain labeling information, including
                                certain warnings and performance
                                information.
------------------------------------------------------------------------

    FDA has determined that special controls, in combination with the
general controls, address these risks to health and provide reasonable
assurance of safety and effectiveness. For a device to fall within this
classification, and thus avoid automatic classification in class III,
it would have to comply with the special controls named in this final
order. The necessary special controls appear in the regulation codified
by this order. This device is subject to premarket notification
requirements under section 510(k) of the FD&C Act.

III. Analysis of Environmental Impact

    The Agency has determined under 21 CFR 25.34(b) that this action is
of a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.

IV. Paperwork Reduction Act of 1995

    This final order establishes special controls that refer to
previously approved collections of information found in other FDA
regulations and guidance. These collections of information are subject
to review by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The collections
of information in 21 CFR part 860, subpart D, regarding De Novo
classification have been approved under OMB control number 0910-0844;
the collections of information in 21 CFR part 814, subparts A through
E, regarding premarket approval, have been approved under OMB control
number 0910-0231; the collections of information in part 807, subpart
E, regarding premarket notification submissions, have been approved
under OMB control number 0910-0120; the collections of information in
21 CFR part 820, regarding quality system regulation, have been
approved under OMB control number 0910-0073; and the collections of
information in 21 CFR parts 801and 809, regarding labeling, have been
approved under OMB control number 0910-0485.

List of Subjects in 21 CFR Part 862

    Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
862 is amended as follows:

PART 862--CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES

0
1. The authority citation for part 862 continues to read as follows:

    Authority:  21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

0
2. Add Sec.  862.1622 to subpart B to read as follows:

Sec.  862.1622   Prognostic test for assessment of liver related
disease progression.

    (a) Identification. A prognostic test for assessment of liver
related disease progression is intended to measure one or more analytes
obtained from human samples as an aid in assessing progression of liver
related disease. This device is not intended for diagnosis of any
disease, for monitoring the effect of any therapeutic product, for
assessing progression to hepatocellular carcinoma, or for assessing
disease progression in individuals with viral hepatitis. It is also not
intended for the detection of viruses, viral antigens, or antibodies to
viruses.
    (b) Classification. Class II (special controls). The special
controls for this device are:
    (1) Design verification and validation must include clinical
validation data providing:
    (i) Information demonstrating clinical performance in a population
of patients with liver disease for the different risk categories (e.g.,
at lower risk, at higher risk) for progression of their disease using
well characterized clinical specimens representing the intended use
population collected from multiple

intended clinical sites, or an alternative study design determined to
be appropriate by FDA.
    (ii) Information demonstrating that the outcomes measured and the
length of followup are clinically relevant for the progression of the
specified liver disease.
    (iii) Information demonstrating that the clinical criteria for
determining whether the target disease is present and that the
exclusion and inclusion criteria for subjects who have the target
disease are appropriate.
    (iv) Information demonstrating test performance of the complete
test system, including any sample collection and processing steps.
    (v) Information, provided or referenced, generated in samples from
non-diseased individuals, that demonstrate the upper and lower
reference intervals for the output provided by the device.
    (2) The labeling required under 21 CFR 809.10(b) must include:
    (i) A warning statement that test results are not intended to
diagnose disease or for monitoring the effect of any therapeutic
product.
    (ii) A warning statement that test results are intended to be used
in conjunction with other clinical and diagnostic findings, consistent
with professional standards of practice, including information obtained
by alternative methods, and clinical evaluation, as appropriate.
    (iii) A warning statement that describes any limitations on the
clinical interpretation(s) of the test results.
    (iv) Detailed information on device performance, including any
limitations to the data generated in the clinical study(ies) and
information on device performance in relevant subgroups (e.g., severity
of liver disease at the beginning of the observation period) observed
in the clinical study(ies).
    (v) Information on the analytical performance of the device,
including demonstration of reproducibility across multiple sites and
multiple reagent lots, or an alternative reproducibility study design
determined to be appropriate by FDA.

    Dated: January 6, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-00480 Filed 1-13-23; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: October 8, 2010 (Volume 75, Number 195)]
[Proposed Rules]
[Page 62354-62358]
[DOCID:fr08oc10-13]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R04-OAR-2010-0663-201037; FRL-9212-7]

Approval and Promulgation of Implementation Plans; Tennessee:
Approval of Section 110(a)(1) Maintenance Plan for the 1997 8-Hour
Ozone Standards for the Nashville, TN Area

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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

SUMMARY: EPA is proposing to approve a draft revision to the Tennessee
State Implementation Plan (SIP), submitted to EPA on August 3, 2010,
for parallel processing. The proposed revision modifies Tennessee's SIP
to address the required maintenance plan for the 1997 8-hour ozone
standards for the Nashville, Tennessee 1997 8-hour ozone maintenance
area, hereafter referred to as ``the Nashville Area.'' The Nashville
Area is comprised of Davidson, Rutherford, Sumner, Williamson, and
Wilson Counties in their entireties. This maintenance plan was
submitted to EPA by the State of Tennessee, through the Tennessee
Department of Environment and Conservation (TDEC), to ensure the
continued attainment of the 1997 8-hour ozone national ambient air
quality standards (NAAQS) through the year 2018 in the Nashville Area.
EPA is approving the SIP revision pursuant to section 110 of the Clean
Air Act (CAA). This maintenance plan meets all the statutory and
regulatory requirements, and is consistent with EPA's guidance.

DATES: Comments must be received on or before November 8, 2010.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R04-
OAR-2010-0663, by one of the following methods:
    1. http://www.regulations.gov: Follow the on-line instructions for
submitting comments.
    2. E-mail<EMAIL_ADDRESS>    3. Fax:<PHONE_NUMBER>.
    4. Mail: EPA-R04-OAR-2010-0663, Regulatory Development Section, Air
Planning Branch, Air, Pesticides and Toxics Management Division, U.S.
Environmental Protection Agency, Region 4, 61 Forsyth Street, SW.,
Atlanta, Georgia 30303-8960.
    5. Hand Delivery or Courier: Lynorae Benjamin, Chief, Regulatory
Development Section, Air Planning Branch, Air, Pesticides and Toxics
Management Division, U.S. Environmental Protection Agency, Region 4, 61
Forsyth Street, SW., Atlanta, Georgia 30303-8960. Such deliveries are
only accepted during the Regional Office's normal hours of operation.
The Regional Office's official hours of business are Monday through
Friday, 8:30 a.m. to 4:30 p.m., excluding federal holidays.
    Instructions: Direct your comments to Docket ID No. EPA-R04-OAR-
2010-0663. EPA's policy is that all comments received will be included
in the public docket without change and may be made available online at
http://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit through http://
www.regulations.gov or e-mail, information that you consider to be CBI
or otherwise protected. The http://www.regulations.gov Web site is an
``anonymous access'' system, which means EPA will not know your
identity or contact information unless you provide it in the body of
your comment. If you send an e-mail comment directly to EPA without
going through http://www.regulations.gov, your e-mail address will be
automatically captured and included as part of the comment that is
placed in the public docket and made available on the Internet. If you
submit an electronic comment, EPA recommends that you include your name
and other contact information in the body of your comment and with any
disk or CD-ROM you submit. If EPA cannot read your comment due to
technical difficulties and cannot contact you for clarification, EPA
may not be able to consider your comment. Electronic files should avoid
the use of special characters, any form of encryption, and be free of
any defects or viruses. For additional information about EPA's public
docket visit the EPA Docket Center homepage at http://www.epa.gov/
epahome/dockets.htm.
    Docket: All documents in the electronic docket are listed in the
http://www.regulations.gov index. Although listed in the index, some
information is not publicly available, i.e., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, is not placed on the Internet and will be
publicly available only in hard copy form. Publicly available docket
materials are available either electronically in http://
www.regulations.gov or in hard copy at the Regulatory Development
Section, Air Planning Branch, Air, Pesticides and Toxics Management
Division, U.S. Environmental Protection Agency, Region 4, 61 Forsyth
Street, SW., Atlanta, Georgia 30303-8960. EPA requests that if at all
possible, you contact the person listed in the FOR FURTHER INFORMATION
CONTACT section to schedule your inspection. The Regional Office's
official hours of business are Monday through Friday, 8:30 a.m. to 4:30
p.m., excluding federal holidays.

FOR FURTHER INFORMATION CONTACT: Royce Dansby-Sparks, Regulatory
Development Section, Air Planning Branch, Air, Pesticides and Toxics
Management Division, U.S. Environmental Protection Agency, Region 4, 61
Forsyth Street, SW., Atlanta, Georgia 30303-8960. The telephone number
is<PHONE_NUMBER>. Mr. Dansby-Sparks can also be reached via electronic
mail at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Table of Contents

I. Background
II. EPA's Analysis of Tennessee's Submittal
III. Proposed Action
IV. Statutory and Executive order Reviews

I. Background

    In accordance with the CAA, the Nashville Area was designated
nonattainment for the 1-hour ozone NAAQS on November 6, 1991, 56 FR
56694 (effective January 6, 1992, 60 FR 7124). On November 14, 2004,
the State of Tennessee, through the TDEC, submitted a request to
redesignate the Nashville Area to attainment for the 1-hour ozone NAAQS
(see 61 FR 55903). Subsequently on August 9, 1995, and January 19,
1996, Tennessee submitted supplementary information which included
revised contingency measures and emission projections. Included with
the 1-hour ozone redesignation request, Tennessee submitted the
required 1-hour ozone monitoring data and maintenance plan ensuring the
Area would remain in attainment for the 1-hour ozone NAAQS for at least
a period of 10 years (consistent with CAA 175A(a)). The maintenance
plan submitted by Tennessee followed EPA guidance for maintenance
areas, subject to section 175A of the CAA.
    On October 30, 1996, EPA approved Tennessee's request to
redesignate the Nashville Area to attainment for the 1-hour ozone NAAQS
(61 FR 55903). The maintenance plan for the Area became effective on
October 30, 1996. Tennessee later updated the maintenance plan in
accordance with section 175(A)(b) on August 10, 2005, to extend the
maintenance plan to cover

additional years such that the entire maintenance period was for at
least 20 years after the initial redesignation of the Area to
attainment. EPA approved Tennessee's maintenance plan update for the
Nashville Area on November 1, 2005 (see 70 FR 65838).
    On April 30, 2004, EPA designated and classified areas for the 1997
8-hour ozone NAAQS (69 FR 23858), and published the final Phase 1 Rule
for implementation of the 1997 8-hour ozone NAAQS (69 FR 23951) (Phase
1 Rule), ultimately revoking the 1-hour ozone NAAQS. The Nashville
Area, however, was still required to fulfill requirements under the 1-
hour ozone NAAQS due to its participation in an Early Action Compact
(EAC). For areas participating in an EAC, the effective designation
date for the 1997 8-hour ozone NAAQS was deferred until December 31,
2006, in a final action published by EPA on August 19, 2005 (70 FR
50988) and later extended to April 15, 2008 (71 FR 69022) for most of
the EAC Areas, including Nashville, so long as the Area continued to
meet milestone requirements. Therefore, the requirement for an
attainment area to submit a 10-year maintenance plan under 110(a)(1) of
the CAA and the Phase 1 Rule was also postponed until the Area was
effectively designated for the 1997 8-hour ozone NAAQS. The Nashville
Area was later designated as attainment for the 1997 8-hour ozone
NAAQS, effective April 15, 2008, with the 1-hour ozone requirements no
longer effective on April 15, 2009 (73 FR 17897). The attainment area
was consequently required to submit a 10-year maintenance plan under
section 110(a)(1) of the CAA and the Phase 1 Rule.
    On May 20, 2005, EPA issued guidance providing information on how a
state might fulfill the maintenance plan obligation established by the
CAA and the Phase 1 Rule (Memorandum from Lydia N. Wegman to Air
Division Directors, Maintenance Plan Guidance Document for Certain 8-
hour Ozone Areas Under Section 110(a)(1) of Clean Air Act, May 20,
2005, hereafter referred to as the ``Wegman Memorandum''). On December
22, 2006, the United States Court of Appeals for the District of
Columbia Circuit issued an opinion that vacated EPA's Phase 1 Rule for
the 1997 8-hour ozone NAAQS. South Coast Air Quality Management
District (SQAMD) v. EPA, 472 F.3d 882 (D.C. Cir. 2006). The Court
vacated those portions of the Phase 1 Rule that provided for regulation
of the 1997 8-hour ozone nonattainment areas designated under Subpart 1
in lieu of Subpart 2 (of part D of the CAA), among other portions. The
Court's decision does not alter any requirements under the Phase 1 Rule
for section 110(a)(l) maintenance plans.
    EPA is proposing to take action to approve Tennessee's August 3,
2010, SIP revision, submitted for parallel processing, which satisfy
CAA section 110(a)(1) CAA requirements for a plan providing for
maintenance of the 1997 8-hour ozone NAAQS in the Nashville Area.

II. EPA's Analysis of Tennessee's Submittal

    On August 3, 2010, the State of Tennessee, through the TDEC and the
Metro Nashville/Davidson County Pollution Control Division Office,
submitted a proposed SIP revision for parallel processing containing
the 1997 8-hour ozone maintenance plan for the Nashville Area as
required by section 110(a)(1) of the CAA and the provisions of EPA's
Phase 1 Rule (see 40 CFR 51.905(a)(4)). The purpose of the plan is to
ensure continued attainment and maintenance of the 1997 8-hour ozone
NAAQS until 2018 for this attainment area.
    The August 3, 2010, SIP revision is not yet state-effective,
therefore, Tennessee has requested that EPA ``parallel process'' the
SIP revision. Under this procedure, the Regional Office works closely
with the state while developing new or revised regulations. Generally,
the state submits a copy of the proposed regulation or other revisions
to EPA before conducting its public hearing. EPA reviews this proposed
state action, and prepares a notice of proposed rulemaking. EPA's
notice of proposed rulemaking is published in the Federal Register
during approximately the same time frame that the state is holding its
public hearing. The state and EPA then provide for public comment
periods on both the state and federal actions.
    After Tennessee submits the formal state-effective SIP revision
request (including a response to all public comments raised during the
state's public participation process, and the 1997 8-hour ozone
110(a)(1) maintenance plan), EPA will prepare a final rulemaking notice
for the SIP revision. If Tennessee's rulemaking to address the 1997 8-
hour ozone 110(a)(1) maintenance plan contains changes which occur
after EPA's notice of proposed rulemaking, such change must be
described in EPA's final rulemaking action. If Tennessee's changes are
significant, EPA must decide whether it is appropriate to repropose
action on the state's changes to their submittal to address the 1997 8-
hour ozone 110(a)(1) maintenance plan.
    As required, the plan provides for continued attainment and
maintenance of the 1997 8-hour ozone NAAQS in the Nashville Area for at
least 10 years from the effective date of this Area's designation as
attainment for the 1997 8-hour ozone NAAQS. The plan also includes
components illustrating how the Area will continue attainment of the
1997 8-hour ozone NAAQS, and provides contingency measures. The Section
110(a)(1) plan components are discussed below for the Nashville Area.
    (a) Attainment Inventory. In order to demonstrate maintenance in
the aforementioned area, Tennessee developed comprehensive inventories
of volatile organic compounds (VOC) and nitrogen oxide (NOX)
emissions from area, point, on-road mobile, non-road mobile, and
aircraft, locomotive, and commercial marine (ALM) sources using 2007 as
the base year. According to the May 20, 2005, guidance, a state may use
one of the three years for which the 1997 8-hour attainment designation
was based (2001, 2002, and 2003) as their attainment inventory base
year. However, due to the fact that the Nashville Area was an EAC area,
the effective date of designation was deferred to April 15, 2008, and
therefore consideration of a later base year of 2005, 2006, or 2007 was
required for the purpose of an emissions inventory. For the purpose of
this maintenance plan, Tennessee chose 2007 as the attainment level
emissions base year for the Nashville Area. The state's submittal
contains the detailed inventory data and summaries by source category
for the Nashville Area.
    In accordance with Consolidated Emissions Reporting Rule
requirements (CERR), Tennessee compiles a statewide emissions inventory
for point sources on an annual basis. On-road mobile emissions of VOC
and NOX were estimated using MOBILE6.2 motor vehicle
emissions factor computer model. Non-road mobile emissions data were
derived using the U.S. EPA's NONROAD 2008 model. ALM emissions were
primarily estimated based on EPA's National Emissions Inventory.
    In projecting data for the maintenance year 2018 emissions
inventories, Tennessee used several methods to project data from the
base year 2007 to the interim years 2010, 2014, and 2018. These
projected inventories were developed using EPA-approved technologies
and methodologies including the Southeastern Emissions Modeling,
Analysis, and Planning methodology. Projected point, area, and non-road
mobile source inventories were developed using the 2007 base year
inventories and economic growth

factors from EPA's Economic Growth and Analysis System.
    The following tables provide VOC and NOX emissions data
for the 2007 base attainment year inventories, as well as projected VOC
and NOX emissions inventory data for 2010, 2014, and 2018.
The Phase 1 Rule provides that the 10-year maintenance period begin as
of the effective date of designation for the 1997 8-hour NAAQS for the
Area. The designations for the 13 EAC attainment areas (of which
Nashville was one) were effective in April 2008 so the maintenance
period must end no earlier than 2018.

                 Table 1--2007 VOC and NOX Base Year Emissions Inventory for the Nashville Area
                                                   [Tons/day]
----------------------------------------------------------------------------------------------------------------
              County                   Point         Area        Onroad      Nonroad        ALM        Total *
----------------------------------------------------------------------------------------------------------------
                                                                  --NOX emissions--
                                   -----------------------------------------------------------------------------
Davidson..........................        11.52         0.62        45.70         9.57         3.35        70.76
Rutherford........................         0.33         2.79        17.29         5.45         1.26        27.11
Sumner............................        18.74         0.24         6.07         2.57         0.78        28.41
Williamson........................         0.06         0.86        12.60         3.58         1.36        18.47
Wilson............................         0.00         1.23        13.12         2.19         0.15        16.68
                                   -----------------------------------------------------------------------------
    Total *.......................        30.65         5.75        94.79        23.36         6.90       161.44
----------------------------------------------------------------------------------------------------------------

----------------------------------------------------------------------------------------------------------------
              County                   Point         Area        Onroad      Nonroad        ALM         Total
----------------------------------------------------------------------------------------------------------------
                                                                  --VOC emissions--
                                   -----------------------------------------------------------------------------
Davidson..........................         5.05        20.98        17.73        15.06         0.60        59.42
Rutherford........................         5.97        11.02         6.65         4.44         0.20        28.28
Sumner............................         0.97         6.78         3.53         2.68         0.08        14.05
Williamson........................         0.31         6.00         5.05         2.64         0.07        14.06
Wilson............................         0.00         4.88         3.32         4.80         0.05        13.04
                                   -----------------------------------------------------------------------------
    Total *.......................        12.31        49.66        36.27        29.62         1.00       128.85
----------------------------------------------------------------------------------------------------------------
* Due to conventional rounding rules, emission totals listed in Tables 1 and 2 may not reflect the absolute
  mathematical totals.

                    Table 2--Projected VOC and NOX Emissions Inventory for the Nashville Area
                                                   [Tons/day]
----------------------------------------------------------------------------------------------------------------
                         Source type                              2007         2010         2014         2018
----------------------------------------------------------------------------------------------------------------
                                                                               --NOX emissions--
                                                             ---------------------------------------------------
Point.......................................................        30.65        30.33        31.59        31.61
Area........................................................         5.75         5.88         6.07         6.25
Onroad......................................................        94.79        76.72        55.79        28.53
Nonroad.....................................................        23.36        21.08        16.38        12.37
ALM.........................................................         6.90         6.93         7.12         7.36
                                                             ---------------------------------------------------
    Total *.................................................       161.44       140.93       116.95        86.11
                                                             ---------------------------------------------------
                                                                               --VOC emissions--
                                                             ---------------------------------------------------
Point.......................................................        12.31        12.49        13.18        14.50
Area........................................................        49.66        51.48        54.14        57.77
Onroad......................................................        36.27        30.43        22.13        14.84
Nonroad.....................................................        29.62        25.87        20.27        16.70
ALM.........................................................         1.00         1.07         1.17         1.27
                                                             ---------------------------------------------------
    Total *.................................................       128.85       121.34       110.88       105.07
----------------------------------------------------------------------------------------------------------------
* Due to conventional rounding rules, emission totals listed in Tables 1 and 2 may not reflect the absolute
  mathematical totals.

    As shown in Table 2 above, the Nashville Area is projected to
steadily decrease its total VOC and NOX emissions from the
base year of 2007 to the maintenance year of 2018. This VOC and
NOX emission decrease demonstrates continued attainment/
maintenance of the 1997 8-hour ozone NAAQS for ten years from 2008
(i.e., the year the Area was effectively designated attainment for the
1997 8-hour ozone NAAQS) as required by the CAA and Phase 1 Rule.
NOX and VOC emissions are expected to decrease approximately
47 and 18 percent, respectively, from the attainment base year to 2018.
These projected reductions of ozone precursors ensure continued
maintenance of the 1997 8-hour ozone NAAQS.
    The attainment inventories submitted by Tennessee for this Area are
consistent with the criteria as discussed in the Wegman Memorandum. EPA
finds that the future emission levels for the projected years 2010,
2014, and 2018, are expected to be less than the attainment level
emissions in 2007. In

the event that future 1997 8-hour ozone monitoring values in the Area
are found to violate the 1997 8-hour ozone NAAQS, the contingency plan
section of the Area's maintenance plan includes measures that will be
promptly implemented to ensure that the Area returns to maintenance of
the 1997 ozone NAAQS. Please see section (d) Contingency Plan, below,
for additional information related to the contingency measures in the
maintenance plan.
    (b) Maintenance Demonstration. The primary purpose of a maintenance
plan is to demonstrate how an area will continue to remain in
attainment with the 1997 8-hour ozone standards for the 10-year period
following the effective date of designation as unclassifiable/
attainment. The required end projection year for the Nashville Area is
2018. As discussed in section (a) Attainment Inventory above, Tennessee
identified the level of ozone-forming emissions that were consistent
with attainment of the NAAQS for ozone in 2007. Tennessee projected VOC
and NOX emissions for 2010, 2014, and 2018. EPA finds that
the future emissions levels in these years are expected to be below the
emissions levels in 2007 in the Nashville Area.
    Tennessee's SIP revision for the maintenance plan for the Nashville
Area also relies on the closure of large parts of the operations of
E.I. du Pont Nemours and Company located in Davidson County resulting
in significant reductions of both VOC and NOX. The Nashville
Attainment Area is also benefiting from the following reductions that
are occurring in other states in the Southeast: (1) North Carolina
Clean Smokestacks Act, (2) Atlanta/Northern Kentucky/Birmingham 1-hour
SIPs, (3) NOX reasonably available control technology in
1997 8-hour ozone nonattainment area SIP, and (4) implementation of
NOX SIP Call Phase 1 in southeastern states. Moreover,
despite the legal status of the Clean Air Interstate Rule (CAIR) as
remanded, many facilities have already installed or are continuing with
plans to install emission controls that may benefit the Nashville Area.
    (c) Consideration of CAIR. The NOX SIP Call requires
states to make significant, specific emissions reductions. It also
provided a mechanism, the NOX Budget Trading Program, which
states could use to achieve those reductions. When EPA promulgated
CAIR, it discontinued (starting in 2009) the NOX Budget
Trading Program, 40 CFR 51.121(r), but created another mechanism--the
CAIR ozone season trading program--which states could use to meet their
SIP Call obligations (70 FR 25289-90). EPA notes that a number of
states, when submitting SIP revisions to require sources to participate
in the CAIR ozone season trading program, removed the SIP provisions
that required sources to participate in the NOX Budget
Trading Program. In addition, because the provisions of CAIR, including
the ozone season NOX trading program, remain in place during
the remand (North Carolina v. EPA, 550 F.3d 1176 (DC Cir. 2008)), EPA
is not currently administering the NOX Budget Trading
Program. Nonetheless, all states, regardless of the current status of
their regulations that previously required participation in the
NOX Budget Trading Program, will remain subject to all of
the requirements in the NOX SIP Call, even if the existing
CAIR ozone season trading program is withdrawn or altered. In addition,
the anti-backsliding provisions of 40 CFR 51.905(f) specifically
provide that the provisions of the NOX SIP Call, including
the statewide NOX emission budgets, continue to apply after
revocation of the 1-hour standards.
    All NOX SIP Call states have SIPs that currently satisfy
their obligations under the SIP Call, the SIP Call reduction
requirements are being met, and EPA will continue to enforce the
requirements of the NOX SIP Call even after any response to
the CAIR remand. For these reasons, EPA believes that regardless of the
status of the CAIR program, the NOX SIP call requirements
can be relied upon in demonstrating maintenance.
    (d) Ambient Air Quality Monitoring. The table below shows design
values \1\ for the Nashville Area. The ambient ozone monitoring data
were collected at sites that were selected with assistance from EPA and
are considered representative of the areas of highest concentration.
The State of Tennessee and Metro Nashville/Davidson County Pollution
Control Division Office will continue to conduct ambient air quality
monitoring programs for ozone in their respective areas. All monitoring
programs will continue in accordance with applicable EPA monitoring
requirements contained in 40 CFR part 58. Any modification to the
ambient air monitoring network will be accomplished through close
consultation with EPA. The Nashville Area has not had a monitor design
value that exceeded the 1997 8-hour NAAQS since the 2001-2003 design
value time-period as seen in Table 3.\2\
---------------------------------------------------------------------------

    \1\ The air quality design value at a monitoring site is defined
as the concentration that when reduced to the level of the standard
ensures that the site meets the standard. For a concentration-based
standard, the air quality design value is simply the standard-
related test statistic. Thus, for the primary and secondary 1997 8-
hour ozone standards, the 3-year average annual forth-highest daily
maximum 8-hour average ozone concentration is also the air quality
design value for the site. 40 CFR part 50, appendix I, section 3.
    \2\ Under EPA regulations found at 40 CFR part 50, the 1997 8-
hour ozone NAAQS are attained when the 3-year average of the annual
fourth-highest daily maximum 8-hour ambient air quality ozone
concentrations is less than 0.08 parts per million (i.e., 0.084 when
rounding is considered).

               Table 3--Maximum 8-Hour Ozone Design Values
                           [Parts per million]
------------------------------------------------------------------------
                        Years                            Design value
------------------------------------------------------------------------
1994-1996...........................................               0.099
1995-1997...........................................               0.099
1996-1998...........................................               0.101
1997-1999...........................................               0.102
1998-2000...........................................               0.100
1999-2001...........................................               0.093
2000-2002...........................................               0.088
2001-2003...........................................               0.086
2002-2004...........................................               0.083
2003-2005...........................................               0.082
2004-2006...........................................               0.083
2005-2007...........................................               0.084
2006-2008...........................................               0.084
2007-2009...........................................               0.078
------------------------------------------------------------------------

    The maximum design value for 2007 through 2009 identified in Table
3 demonstrate attainment of the 1997 8-hour ozone NAAQS at a level of
0.079 parts per million (ppm). Further, these design values indicate
that the Nashville maintenance Area is expected to continue attainment
of the 1997 8-hour ozone NAAQS based on a gradual decrease in the
design values. The attainment level for the 1997 8-hour ozone standards
is 0.080 ppm, effectively 0.084 ppm with the rounding convention. In
the event that a design value for the Nashville Area monitors exceed
the 1997 8-hour ozone standards, one or more contingency measures
included in Tennessee's maintenance plan would be promptly implemented
in accordance with the contingency plan, as discussed below.
    (e) Contingency Plan. In accordance with 40 CFR 51.905(a)(4)(ii)
and the Wegman Memorandum, the Section 110(a)(1) maintenance plan
includes contingency provisions to promptly correct a violation of the
1997 8-hour ozone NAAQS that may occur. The state of Tennessee has
established two triggers to activate contingency measures including:
(1) Quality assured ambient air quality monitoring data showing a
violation of the 1997 8-hour ozone NAAQS at any monitor, and (2) an
increase in the actual ozone precursor emissions of at least ten

percent over the 2007 emissions inventory. In the maintenance plan, if
contingency measures are triggered, the State of Tennessee and Metro
Nashville/Davidson County Pollution Control Division Office are
committed to implement the measures as expeditiously as practicable,
including adopting one or more contingency measures as expeditiously as
practical and implementing the measures within twenty-four months of
the triggering event. The contingency measures include: (1) Expansion
of NOX and/or VOC control strategies in the Nashville
Maintenance Area; (2) in conjunction with the State of Tennessee,
implementation of mobile source transportation controls such as reduced
speed limits for heavy duty diesel vehicles; (3) lowering major source
thresholds; (4) expansion of the open burning ban in Davidson County to
include homeowners in the area; (5) implementation of anti-idling
legislation; and/or (6) any other control measure determined to be
appropriate at the time a trigger is exceeded.
    These contingency measures and schedules for implementation satisfy
EPA's long-standing guidance on the requirements of section 110(a)(1)
of continued attainment. Continued attainment of the 1997 8-hour ozone
NAAQS in the Nashville Area will depend, in part, on the air quality
measures discussed previously (see section II). In addition, the State
of Tennessee and Metro Nashville/Davidson County Pollution Control
Division Office commit to verify the 1997 8-hour ozone status in this
maintenance plan through periodic ozone precursor emission inventory
updates. Emission inventory updates will be completed by 18 months
following the end of the inventory year to verify continued attainment
of the 1997 8-hour ozone NAAQS.

III. Proposed Action

    Pursuant to section 110(a)(1) of the CAA, EPA is proposing to
approve the maintenance plan addressing the 1997 8-hour ozone standards
in the Nashville Area, submitted by the State of Tennessee, through
TDEC, on August 3, 2010. The maintenance plan ensures continued
attainment of the 1997 8-hour ozone NAAQS through the maintenance year
2018. EPA has evaluated Tennessee's submittal and has preliminarily
determined that it meets the applicable requirements of the CAA and EPA
regulations, and is consistent with EPA policy.
    On March 12, 2008, EPA issued revised ozone NAAQS. On September 16,
2009, EPA announced it would reconsider the 2008 NAAQS for ozone and
proposed a new schedule for designations for the reconsidered NAAQS.
The current action, however, is being taken to address requirements
under the 1997 8-hour ozone standards. Requirements for the Nashville
Area under the 2010 reconsidered ozone NAAQS will be addressed in the
future.

IV. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the Act and applicable
Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. Accordingly, this
proposed action merely approves state law as meeting Federal
requirements and does not impose additional requirements beyond those
imposed by state law. For that reason, this proposed action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Order
12866 (58 FR 51735, October 4, 1993);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, this proposed rule does not have tribal implications
as specified by Executive Order 13175 (65 FR 67249, November 9, 2000),
because the SIP is not approved to apply in Indian country located in
the state, and EPA notes that it will not impose substantial direct
costs on tribal governments or preempt tribal law.

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Ozone, Volatile
organic compounds.

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

    Dated: September 28, 2010.
Gwendolyn Keyes Fleming,
Regional Administrator, Region 4.
[FR Doc. 2010-25448 Filed 10-7-10; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 75, Number 248 (Tuesday, December 28, 2010)]
[Notices]
[Pages 81605-81606]
[FR Doc No: 2010-32662]

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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2010-0877; FRL-8858-9]

Endocrine Disruptor Screening Program (EDSP); Announcing the
Availability of a Draft for Weight-of-Evidence Guidance Document:
Evaluating Results of EDSP Tier 1 Screening To Identify Candidate
Chemicals for Tier 2 Testing; Extension of Comment Period

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice; extension of comment period.

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

SUMMARY: EPA published a notice in the Federal Register of November 4,
2010, concerning a draft guidance document titled, ``Weight-of-Evidence
Guidance Document: Evaluating Results of EDSP Tier 1 Screening To
Identify Candidate Chemicals for Tier 2 Testing.'' EPA received a
request for an extension of the comment period. EPA is extending the
comment period from January 3, 2011, to February 3, 2011.

DATES: Comments, identified by docket identification (ID) number EPA-
HQ-OPPT-2010-0877, must be received on or before February 3, 2011.

ADDRESSES: Follow the detailed instructions as provided under ADDRESSES
in the Federal Register document of November 4, 2010.

FOR FURTHER INFORMATION CONTACT: For technical information contact: Don
Bergfelt, Office of Science Coordination and Policy (7203M),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number:<PHONE_NUMBER>; e-mail
address<EMAIL_ADDRESS>    For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:
    This document extends the public comment period established in the
Federal Register notice of November 4, 2010 (75 FR 67963) (FRL-8849-8).
In that notice, EPA announced the

availability for public review and comment of a draft guidance document
titled, ``Weight-of-Evidence Guidance Document: Evaluating Results of
EDSP Tier 1 Screening To Identify Candidate Chemicals for Tier 2
Testing.'' EPA is hereby extending the comment period, which was set to
end on January 3, 2011, to February 3, 2011.
    To submit comments, or access the docket, please follow the
detailed instructions as provided under ADDRESSES in the Federal
Register notice of November 4, 2010. If you have questions, consult the
technical person listed under FOR FURTHER INFORMATION CONTACT.

List of Subjects

    Environmental protection, Endocrine disruptors, Screening assays,
Weight-of-evidence.

    Dated: December 20, 2010.
Stephen A. Owens,
Assistant Administrator, Office of Chemical Safety and Pollution
Prevention.
[FR Doc. 2010-32662 Filed 12-27-10; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 83, Number 15 (Tuesday, January 23, 2018)]
[Notices]
[Pages 3199-3203]
[FR Doc No: 2018-01092]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-82521; File No. SR-ISE-2018-04]

Self-Regulatory Organizations; Nasdaq ISE, LLC; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change Relating to Market
Maker Orders

January 17, 2018.
    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 January 5, 2018, Nasdaq ISE, LLC (``ISE'' or ``Exchange'') filed
with the Securities and Exchange Commission (``Commission'') the
proposed rule change as described in Items I and II 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

    The Exchange proposes to amend ISE Rule 805 to permit Market Makers
\3\ to enter additional order types in the options classes to which
they are appointed.
---------------------------------------------------------------------------

    \3\ Market Makers refers to ``Competitive Market Makers'' and
``Primary Market Makers'' collectively. See ISE Rule 100(a)(25).
---------------------------------------------------------------------------

    The text of the proposed rule change is set forth below. Proposed
new language is italicized; deleted text is in brackets.
* * * * *

Nasdaq ISE Rulebook

* * * * *

Rule 805. Market Maker Orders

    (a) Options Classes to Which Appointed. Market makers may enter all
order types defined in Rule 715 in the options classes to which they
are appointed under Rule 802, except Stopped Orders, Reserve Orders and
Customer Cross Orders.[not place principal orders to buy or sell
options in the options classes to which they are appointed under Rule
802, other than opening only orders, immediate-or-cancel orders, market
orders, fill-or-kill orders, sweep orders, complex orders, and block-
size orders executed through the Block Order Mechanism pursuant to Rule
716(c).] Competitive Market Makers shall comply with the provisions of
Rule 804(e)(2)(iii) upon

the entry of such orders if they were not previously quoting in the
series.
    (b) Options Classes Other Than Those to Which Appointed.
    (1) A market maker may enter all order types permitted to be
entered by non-customer participants under the Rules to buy or sell
options in classes of options listed on the Exchange to which the
market maker is not appointed under Rule 802, except for Reserve
Orders, provided that:
    (i) and (ii) No change.
    (2) and (3) No change.
* * * * *

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 this rule change is to permit Market Makers to enter
principal orders to buy or sell options in the options classes to which
they are appointed under Rule 802 \4\ for all order types listed in
Rule 715 except for Stopped Orders,\5\ Reserve Orders \6\ and Customer
Cross Orders.\7\ This filing is intended to permit Market Makers to
execute most of the same order types, which today they are permitted to
enter on other options markets.\8\ In addition, this filing is intended
to amend ISE Rule 805(b)(1) to indicate that Reserve Orders are not
permitted to be entered by ISE Market Makers in non-appointed options
classes. Today, ISE Market Makers may not enter Reserve Orders in
either appointed or non-appointed options classes. Today, while the
System prohibits ISE Market Makers from entering Reserve Orders, ISE
Rule 805(b)(1) does not indicate the restriction.
---------------------------------------------------------------------------

    \4\ ISE Rule 802 concerns the appointment of Market Makers.
    \5\ A stopped order is a limit order that meets the requirements
of Rule 1901(b)(8). To execute stopped orders, Members must enter
them into the Facilitation Mechanism or Solicited Order Mechanism
pursuant to Rule 716. See ISE Rule 715(b)(6).
    \6\ A Reserve Order is a limit order that contains both a
displayed portion and a non-displayed portion. Both the displayed
and non-displayed portions of a Reserve Order are available for
potential execution against incoming marketable orders. A non-
marketable Reserve Order will rest on the order book. The displayed
portion of a Reserve Order shall be ranked at the specified limit
price and the time of order entry. The displayed portion of a
Reserve Order will trade in accordance with Rule 713(c) and (d) for
Priority Customer Orders, and Rule 713(e) and Supplementary Material
.01, for Professional Orders. When the displayed portion of a
Reserve Order is decremented, either in full or in part, it shall be
refreshed from the non-displayed portion of the resting Reserve
Order. If the displayed portion is refreshed in part, the new
displayed portion shall include the previously displayed portion.
Upon any refresh, the entire displayed portion shall be ranked at
the specified limit price and obtain a new time stamp, i.e., the
time that the new displayed portion of the order was refreshed. The
new displayed portion will trade in accordance with Rule 713(c) and
(d) for Priority Customer Orders, and Rule 713(e) and Supplementary
Material .01, for Professional Orders. The initial non-displayed
portion of a Reserve Order rests on the order book and is ranked
based on the specified limit price and time of order entry.
Thereafter, non-displayed portions, if any, always obtain the same
time stamp as that of the new displayed portion in subparagraph 4
above. The non-displayed portion of any Reserve Order is available
for execution only after all displayed interest has been executed.
The non-displayed portion of any Reserve Order will trade in
accordance with Rule 713(c) and (d) for Priority Customer Orders,
and Rule 713(e) and Supplementary Material .01, for Professional
Orders. See ISE Rule 715(g).
    \7\ A Customer Cross Order is comprised of a Priority Customer
Order to buy and a Priority Customer Order to sell at the same price
and for the same quantity. See ISE Rule 715(i).
    \8\ NYSE Arca, Inc. (``NYSE Arca'') and NYSE American LLC
(``NYSE American'') do not limit the types of orders that can be
entered by market makers. See NYSE Arca Rule 6.37C-O and NYSE
American Rule 925.2NY.
---------------------------------------------------------------------------

Appointed Options Classes
    Today, as noted in ISE Rule 805(a), a Market Maker may not place
principal orders to buy or sell options in the options classes to which
they are appointed under Rule 802, other than opening only orders,\9\
immediate-or-cancel orders,\10\ market orders, fill-or-kill orders,\11\
sweep orders,\12\ complex orders,\13\ and block-size orders \14\
executed through the Block Order Mechanism \15\ pursuant to Rule
716(c). At this time, the Exchange proposes to expand the order types
which Market Makers are permitted to enter on ISE.\16\ The Exchange is
amending ISE Rule 805(a) to make clear which order types a Market Maker
in an appointed options class may submit. Additionally, ISO Orders,
All-Or-None Orders, Stop Orders, Qualified Contingent Cross Orders,
Attributable Orders, Do-Not-Route Orders, QCC with Stock Orders,
Opening Sweep Orders, Cancel and Replace Orders,\17\ and Add Liquidity
Orders are accepted on ISE today from Market Makers as principal orders
as modifiers of the allowable non-resting order types, although they
are not specifically detailed in the rule. This rule change will
further detail and align the rule text with the system functionality by
making clear that Maker Makers may enter all order types defined in
Rule 715 in the options classes to which they are appointed under Rule
802, except Stopped Orders, Reserve Orders and Customer Cross Orders.
---------------------------------------------------------------------------

    \9\ An Opening Only order is a limit order that can be entered
for the opening rotation only. Any portion of the order that is not
executed during the opening rotation is cancelled. See ISE Rules
717(o).
    \10\ An immediate-or-cancel order is a limit order that is to be
executed in whole or in part upon receipt. Any portion not so
executed is to be treated as cancelled. An immediate-or-cancel order
entered by a Market Maker through the Specialized Quote Feed
protocol will not be subject to the (i) Limit Order Price Protection
and Size Limitation Protection as defined in ISE Rule 714(b)(2) and
(3); or (ii) Limit Order Price Protection as defined in
Supplementary Material .07(d) to ISE Rule 722. See ISE Rule
715(b)(2).
    \11\ A fill-or-kill order is a limit order that is to be
executed in its entirety as soon as it is received and, if not so
executed, treated as cancelled. See ISE Rule 715(b)(2).
    \12\ A Sweep Order is a limit order that is to be executed in
whole or in part on the Exchange and the portion not so executed
shall be routed pursuant to Supplementary Material .05 to Rule 1901
to Eligible Exchange(s) for immediate execution as soon as the order
is received by the Eligible Exchange(s). Any portion not immediately
executed by the Eligible Exchange(s) shall be canceled. If a Sweep
Order is not marketable when it is submitted to the Exchange, it
shall be canceled. See ISE Rule 715(s).
    \13\ A complex order is any order involving the simultaneous
purchase and/or sale of two or more different options series in the
same underlying security, for the same account, in a ratio that is
equal to or greater than one-to-three (.333) and less than or equal
to three-to-one (3.00) and for the purpose of executing a particular
investment strategy. See ISE Rule 722(a)(1).
    \14\ Block-size orders are orders for fifty (50) contracts or
more. See ISE Rule 716(a).
    \15\ The Block Order Mechanism is a process by which a Member
can obtain liquidity for the execution of block-size orders. See ISE
Rule 716(c).
    \16\ This expansion would include Good-Till-Date Orders, GTC
Orders, Limit Orders, and Stop Limit Orders as new acceptable order
types.
    \17\ Cancel and Replace Orders shall mean a single message for
the immediate cancellation of a previously received order and the
replacement of that order with a new order. If the previously placed
order is already filled partially or in its entirety, the
replacement order is automatically canceled or reduced by the number
of contracts that were executed. The replacement order will retain
the priority of the cancelled order, if the order posts to the Order
Book, provided the price is not amended, size is not increased, or
in the case of Reserve Orders, size is not changed. If the
replacement portion of a Cancel and Replace order does not satisfy
the system's price or other reasonability checks (e.g., ISE Rule
710; ISE Rule 711(c); ISE Rule 714(b)(2); and ISE Rule 722(b)(1) and
Supplementary Material .07 (b), (c) and (d) to Rule 722) the
existing order shall be cancelled and not replaced. See
Supplementary Material .02 to ISE Rule 715.

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

    Today, ISE Market Makers, who are appointed and non-appointed in a
particular options class, may submit orders without limitation, unless
otherwise restricted by the order type as discussed herein. The
Exchange proposes to permit Market Makers to enter all order types,
which are listed in ISE Rule 715, except for Stopped Orders, Reserve
Orders and Customer Cross Orders. The Exchange notes that today Market
Makers are not eligible to execute either Customer Cross Orders, which
are Customer orders, or Stopped Orders, which are intended for the
account of a customer.\18\ With respect to Reserve Orders, the Exchange
proposes to continue to restrict Market Makers from entering Reserve
Orders in their appointed options class. The Exchange believes that
Market Maker liquidity should be displayed liquidity. For these
reasons, and to remain competitive with other markets, the Exchange
proposes to permit Market Makers to enter all orders they are eligible
to submit in their appointed class with the exception of Reserve Orders
and also restrict Reserve Orders in the non-appointed classes.
---------------------------------------------------------------------------

    \18\ ISE Rule 1901(b)(8) states, ``The transaction that
constituted the Trade-Through was the execution of an order for
which, at the time of receipt of the order, a Member had guaranteed
an execution at no worse than a specified price (a ``stopped
order''), where: (i) The stopped order was for the account of a
Customer; (ii) the Customer agreed to the specified price on an
order-by-order basis; and (iii) the price of the Trade-Through was,
for a stopped buy order, lower than the national Best Bid in the
options series at the time of execution, or, for a stopped sell
order, higher than the national Best Offer in the options series at
the time of execution . . .''
---------------------------------------------------------------------------

Non-Appointed Options Classes
    Today, for the reasons noted above, the Exchange does not permit
Market Makers to enter Reserve Orders in non-appointed options classes.
However, the current rule text does not provide this limitation. The
Exchange proposes to amend the current rule text at ISE Rule 805(b)(1)
to codify this limitation.
2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act,\19\ in general, and furthers the objectives of Section
6(b)(5) of the Act,\20\ 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 providing Market Makers access to trade order types which
are currently permissible to be traded in on other options exchanges
today.\21\ The Exchange believes that permitting Market Makers to enter
all eligible order types, except Reserve Orders, in both appointed and
non-appointed options classes offers no advantage to Market Makers
under the Exchange's market structure, including, but not limited to,
under the priority and trade allocation rules in ISE Rule 713 and
various risk protection mechanism rules applicable to Market Makers in
ISE Rule 804.\22\ Today, other non-Market Maker participants may submit
these order types on ISE.
---------------------------------------------------------------------------

    \19\ 15 U.S.C. 78f(b).
    \20\ 15 U.S.C. 78f(b)(5).
    \21\ See note 8 above.
    \22\ Today, Market Makers are not eligible to execute either
Customer Cross Orders, which are Customer orders, or Stopped Orders,
which are intended for the account of a customer.
---------------------------------------------------------------------------

    The Exchange notes that previously, ISE prohibited non-customer
trading by Electronic Access Members (``EAMs'') for principal or agent
transactions.\23\ At that time, ISE represented that, in an electronic
market, non-customer market orders have the potential to create market
volatility by trading at different price levels until their order is
fully executed. ISE further noted that, without this restriction, non-
customers would be able to use large-size orders to quickly take out
ISE's entire order book without giving other market participants an
opportunity to react.\24\ When the restriction was adopted, there were
various limitations imposed on non-customer trading. For example,
displayed quotes were firm only for public customer orders. Since that
time, electronic options trading has evolved. With the adoption of
trade-through protection under the intermarket linkage, every order
must be executed at the best quoted price. Further, ISE has also
removed restrictions on non-customer trading. For example, EAMs may now
submit non-customer limit orders regardless of the size of the order
where previously EAMs were prohibited from submitting orders for non-
customers that caused ISE's best bid and offer to be for less than 10
contracts.\25\
---------------------------------------------------------------------------

    \23\ See Securities Exchange Act Release No. 42455 (February 24,
2000), 65 FR 11388 (March 2, 2000) (File No. 10-127) (In the Matter
of the Application of The International Securities Exchange LLC for
Registration as a National Securities Exchange; Findings and Opinion
of the Commission).
    \24\ Id.
    \25\ See Securities Exchange Act Release No. 49602 (April 22,
2004), 69 FR 23841 (April 30, 2004) (SR-ISE-2003-26).
---------------------------------------------------------------------------

    The Exchange does not believe there is any reason to restrict
Market Makers in entering order types, except for the restriction
related to Reserve Orders, in options classes in which they are
appointed. Unlike other order types, the Reserve Order is a limit order
that contains both a displayed portion and a non-displayed portion.\26\
Both the displayed and non-displayed portions of a Reserve Order are
available for potential execution against incoming marketable orders.
When the displayed portion of a Reserve Order is decremented, either in
full or in part, it shall be refreshed from the non-displayed portion
of the resting Reserve Order. The Exchange believes that because a
Reserve Order contains a non-displayed potion, Market Makers should not
be permitted to enter this order. Market Makers are required to make
markets that, absent changed market conditions, will be honored for the
number of contracts entered into the Exchange's System in all series of
options classes to which the market maker is appointed.\27\ The
Exchange believes that these markets should be transparent. Today, ISE
Market Makers are not permitted to enter Reserve Orders in either
appointed or non-appointed options classes. The Exchange proposes to
specifically note this limitation in both Rule 805(a) and (b) as an
exception. The Exchange notes that this limitation is specifically not
noted in Rule 805(b) today despite the fact that the limitation exists
in the System today.
---------------------------------------------------------------------------

    \26\ See ISE Rule 715(g).
    \27\ See ISE Rule 803(b)(2).
---------------------------------------------------------------------------

    The Exchange is also amending ISE Rule 805(a) to detail the types
of non-resting order types and their modifiers with respect to ISO
Orders, All-Or-None Orders, Stop Orders, Qualified Contingent Cross
Orders, Attributable Orders, Do-Not-Route Orders, QCC with Stock
Orders, Opening Sweep Orders, Cancel and Replace Orders, and Add
Liquidity Orders. This rule change will detail and align the rule text
with the system functionality and make clear which order types a Market
Maker may submit in appointed options classes.
    ISE Market Makers continue to be obligated to add liquidity on ISE.
The Exchange also notes that ISE Rule 805(b)(2) and (3) restricts the
number of contracts that a Market Maker may enter in an options class
to which the Market Maker is not appointed.\28\ The Exchange

notes that it also requires Market Makers to abide by certain quoting
requirements, in the options classes in which they are appointed
pursuant to ISE Rule 802, in order to maintain the status of a Market
Maker.\29\ The Exchange believes that permitting a Market Maker to
enter additional order types, except Reserve Orders, in their appointed
options class will permit Market Makers additional latitude to conduct
business on ISE and effectively compete with other market makers on
other options exchanges. Quotes and orders entered by a Market Maker
may not interact against quotes and orders entered on the opposite side
of the market by the same Market Maker.\30\
---------------------------------------------------------------------------

    \28\ The total number of contracts executed during a quarter by
a Competitive Market Maker in options classes to which it is not
appointed may not exceed twenty-five percent (25%) of the total
number of contracts traded by such Competitive Market Maker in
classes to which it is appointed and with respect to which it was
quoting pursuant to Rule 804(e)(2). See ISE Rule 805(b)(2).
    The total number of contracts executed during a quarter by a
Primary Market Maker in options classes to which it is not appointed
may not exceed ten percent (10%) of the total number of contracts
traded per each Primary Market Maker Membership. See ISE Rule
805(b)(3).
    \29\ See ISE Rule 804(e) and Supplementary Material .01 to Rule
804. Orders do not count toward meeting continuous quoting
obligations.
    \30\ See ISE Rule 804(b).
---------------------------------------------------------------------------

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

    The Exchange does not believe that the proposed rule change will
impose any burden on competition not necessary or appropriate in
furtherance of the purposes of the Act. Today, NYSE Arca and NYSE
American place no limitation on the types of orders that can be entered
by market makers in their appointed class.\31\ Accordingly, the
Exchange believes that this proposal does not impose an undue burden on
inter-market competition because each options exchange generally
determines permissible order types for market makers in its trading
environment based on the exchange's individual business policy,
objectives, and trading system. The Exchange's proposal reflects its
policy and objectives, and does not impose an undue burden on intra-
market competition because it treats all market makers uniformly with
respect to permissible order types. Further, this rule change will
align the system functionality with the rule text to reflect the types
of orders a Market Maker in both appointed and non-appointed options
class may submit. The current rule text is not accurate. This rule
filing is intended to detail and align the rule text with the system
functionality in the current text of Rule 805(a) and (b). This proposal
will make clear which order types a Market Maker may submit in both
appointed and non-appointed options classes.
---------------------------------------------------------------------------

    \31\ See note 8 above.
---------------------------------------------------------------------------

    Further, Market Makers, unlike other market participants, are
required to abide by certain quoting requirements, in the options
classes in which they are appointed pursuant to ISE Rule 802, in order
to maintain the status of a Market Maker.\32\ The Exchange also notes
that ISE Rule 805(b)(2) and (3) restricts the number of orders that a
Market Maker may enter in an options class to which the Market Maker is
not appointed.\33\ The Exchange believes that permitting a Market Maker
to enter additional order types, except Reserve Orders, in their
appointed options class will permit Market Makers additional latitude
to conduct business on ISE and effectively compete with other market
makers on other options exchanges.
---------------------------------------------------------------------------

    \32\ See note 29 above.
    \33\ See note 28 above.
---------------------------------------------------------------------------

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 from the date on which it was filed, or
such shorter time as the Commission may designate, it has become
effective pursuant to Section 19(b)(3)(A)(iii) of the Act \34\ and
subparagraph (f)(6) of Rule 19b-4 thereunder.\35\
---------------------------------------------------------------------------

    \34\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \35\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)(iii)
requires a self-regulatory organization to give the Commission
written notice of its intent to file the proposed rule change, along
with a brief description and the text of the proposed rule change,
at least five business days prior to the date of filing of the
proposed rule change, or such shorter time as designated by the
Commission. The Exchange has satisfied this requirement.
---------------------------------------------------------------------------

    A proposed rule change filed under Rule 19b-4(f)(6) \36\ normally
does not become operative prior to 30 days after the date of the
filing. However, Rule 19b-4(f)(6)(iii) \37\ permits the Commission to
designate a shorter time if such action is consistent with the
protection of investors and the public interest. The Exchange has asked
the Commission to waive the 30-day operative delay so that the proposal
may become operative immediately upon filing. The Exchange states that
the proposed rule change will permit Market Makers additional latitude
to conduct business on ISE and effectively compete with other market
makers on other options exchanges. The Exchange further states that the
proposed rule will detail and align the rule text with the system
functionality. The Commission believes that waiver of the 30-day
operative delay is consistent with the protection of investors and the
public interest. Accordingly, the Commission hereby waives the
operative delay and designates the proposed rule change as operative
upon filing.\38\
---------------------------------------------------------------------------

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

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

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to [email protected]. Please include
File Number SR-ISE-2018-04 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-ISE-2018-04. 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-ISE-2018-04 and should be
submitted on or before February 13, 2018.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\39\
Eduardo A. Aleman,
Assistant Secretary.
---------------------------------------------------------------------------

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

[FR Doc. 2018-01092 Filed 1-22-18; 8:45 am]
 BILLING CODE 8011-01-P