[Federal Register Volume 87, Number 180 (Monday, September 19, 2022)]
[Notices]
[Pages 57202-57203]
[FR Doc No: 2022-20195]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-P-0068]

Determination That ENDEP (Amitriptyline Hydrochloride) Oral
Concentrate, 40 Milligrams/Milliliter, Was Not Withdrawn From Sale for
Reasons of Safety or Effectiveness

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) has
determined that ENDEP (amitriptyline hydrochloride) oral concentrate,
40 milligrams (mg)/milliliter (mL), was not withdrawn from sale for
reasons of safety or effectiveness. This determination will allow FDA
to approve abbreviated new drug applications (ANDAs) for ENDEP
(amitriptyline hydrochloride) oral concentrate, 40 mg/mL, if all other
legal and regulatory requirements are met.

FOR FURTHER INFORMATION CONTACT: Kaetochi Okemgbo, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6224,

Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION: Section 505(j) of the Federal Food, Drug,
and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)) allows the submission of
an ANDA to market a generic version of a previously approved drug
product. To obtain approval, the ANDA applicant must show, among other
things, that the generic drug product: (1) has the same active
ingredient(s), dosage form, route of administration, strength,
conditions of use, and (with certain exceptions) labeling as the listed
drug, which is a version of the drug that was previously approved, and
(2) is bioequivalent to the listed drug. ANDA applicants do not have to
repeat the extensive clinical testing otherwise necessary to gain
approval of a new drug application (NDA).
    Section 505(j)(7) of the FD&C Act requires FDA to publish a list of
all approved drugs. FDA publishes this list as part of the ``Approved
Drug Products With Therapeutic Equivalence Evaluations,'' which is
known generally as the ``Orange Book.'' Under FDA regulations, drugs
are removed from the list if the Agency withdraws or suspends approval
of the drug's NDA or ANDA for reasons of safety or effectiveness or if
FDA determines that the listed drug was withdrawn from sale for reasons
of safety or effectiveness (21 CFR 314.162).
    A person may petition the Agency to determine, or the Agency may
determine on its own initiative, whether a listed drug was withdrawn
from sale for reasons of safety or effectiveness. This determination
may be made at any time after the drug has been withdrawn from sale,
but must be made prior to approving an ANDA that refers to the listed
drug (Sec.  314.161 (21 CFR 314.161)). FDA may not approve an ANDA that
does not refer to a listed drug.
    ENDEP (amitriptyline hydrochloride) oral concentrate, 40 mg/mL, is
the subject of ANDA 085749, held by Hoffman-La Roche Inc., and
initially approved on December 23, 1977. ENDEP (amitriptyline
hydrochloride) oral concentrate, 40 mg/mL, is indicated for relief of
symptoms of depression.
    Hoffman-La Roche Inc. has never marketed ENDEP (amitriptyline
hydrochloride) oral concentrate, 40 mg/mL. ANDA 085749 is listed in the
``Discontinued Drug Product List'' section of the Orange Book.
    Hyman, Phelps & McNamara, P.C., submitted a citizen petition dated
January 11, 2022 (Docket No. FDA-2022-P-0068), under 21 CFR 10.30,
requesting that the Agency determine whether ENDEP (amitriptyline
hydrochloride) oral concentrate, 40 mg/mL, was withdrawn from sale for
reasons of safety or effectiveness.
    After considering the citizen petition and reviewing Agency records
and based on the information we have at this time, FDA has determined
under Sec.  314.161 that ENDEP (amitriptyline hydrochloride) oral
concentrate, 40 mg/mL, was not withdrawn for reasons of safety or
effectiveness. The petitioner has identified no data or other
information suggesting that ENDEP (amitriptyline hydrochloride) oral
concentrate, 40 mg/mL, was withdrawn for reasons of safety or
effectiveness. We have carefully reviewed our files for records
concerning the withdrawal of ENDEP (amitriptyline hydrochloride) oral
concentrate, 40 mg/mL, from sale. We have also independently evaluated
relevant literature and data for possible postmarketing adverse events.
We have reviewed the available evidence and determined that this drug
product was not withdrawn from sale for reasons of safety or
effectiveness.
    Accordingly, the Agency will continue to list ENDEP (amitriptyline
hydrochloride) oral concentrate, 40 mg/mL, in the ``Discontinued Drug
Product List'' section of the Orange Book. The ``Discontinued Drug
Product List'' delineates, among other items, drug products that have
been discontinued from marketing for reasons other than safety or
effectiveness. ANDAs that refer to ENDEP (amitriptyline hydrochloride)
oral concentrate, 40 mg/mL, may be approved by the Agency as long as
they meet all other legal and regulatory requirements for the approval
of ANDAs. If FDA determines that labeling for this drug product should
be revised to meet current standards, the Agency will advise ANDA
applicants to submit such labeling.

    Dated: September 14, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-20195 Filed 9-16-22; 8:45 am]
BILLING CODE 4164-01-P


UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

NATIONAL VEHICLE AND FUEL EMISSIONS LABORATORY

2000 TRAVERWOOD DRIVE

ANN ARBOR, MI  48105-2498

									     OFFICE OF

									AIR AND RADIATION

8/25/15

MEMORANDUM

SUBJECT: Test Procedure Meeting with the Engine Manufacturers
Association

FROM: Christopher Laroo

TO:  Greenhouse Gas Emissions Standards and Fuel Efficiency Standards
for Medium- and

Heavy-Duty Engines and Vehicles - Phase 2 - Docket EPA-HQ-OAR-2014-0827

This memo documents a meeting held on August 25 and 26, 2015 between
representatives of the Engine Manufacturers Association and EPA to
discuss test procedures recently proposed in the Phase 2 greenhouse gas
and fuel efficiency standards for heavy-duty vehicles notice of proposed
rulemaking.  The meeting attendees, agenda, and draft part 1065 working
document are enclosed.

The discussion topics included test procedures in 40 CFR part 1065 and
fuel maps for engines as proposed in 1036.535.


[Federal Register: July 19, 2010 (Volume 75, Number 137)]
[Notices]
[Page 41854-41855]
[DOCID:fr19jy10-56]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER10-1730-000]

Great Bay Energy, LLC; Supplemental Notice That Initial Market-
Based Rate Filing Includes Request for Blanket Section 204
Authorization

July 13, 2010.
    This is a supplemental notice in the above-referenced proceeding of
Great Bay Energy, LLC's application for market-based rate authority,
with an accompanying rate tariff, noting that such application includes
a request for blanket authorization, under 18 CFR part 34, of future
issuances of securities and assumptions of liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street, NE.,
Washington, DC 20426, in accordance with Rules 211 and 214 of the
Commission's Rules of Practice and Procedure (18 CFR 385.211 and
385.214). Anyone filing a motion to intervene or protest must serve a
copy of that document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is August 2, 2010.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://
www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor

must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
14 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First St., NE., Washington, DC 20426.
    The filings in the above-referenced proceeding are accessible in
the Commission's eLibrary system by clicking on the appropriate link in
the above list. They are also available for review in the Commission's
Public Reference Room in Washington, DC. There is an eSubscription link
on the Web site that enables subscribers to receive e-mail notification
when a document is added to a subscribed docket(s). For assistance with
any FERC Online service, please e-mail<EMAIL_ADDRESS>or
call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.

Kimberly D. Bose,
Secretary.
[FR Doc. 2010-17554 Filed 7-16-10; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 80, Number 20 (Friday, January 30, 2015)]
[Notices]
[Pages 5104-5105]
[FR Doc No: 2015-01730]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP14-96-000]

Algonquin Gas Transmission, LLC; Notice of Availability of the
Final Environmental Impact Statement for the Proposed Algonquin
Incremental Market Project

    The staff of the Federal Energy Regulatory Commission (FERC or
Commission) has prepared a final environmental impact statement (EIS)
for the Algonquin Incremental Market Project (AIM Project), proposed by
Algonquin Gas Transmission, LLC (Algonquin) in the above-referenced
docket. Algonquin requests authorization to expand its existing
pipeline system from an interconnection at Ramapo, New York to deliver
up to 342,000 dekatherms per day of natural gas transportation service
to the Connecticut, Rhode Island, and Massachusetts markets.
    The final EIS assesses the potential environmental effects of the
construction and operation of the AIM Project in accordance with the
requirements of the National Environmental Policy Act (NEPA). The FERC
staff concludes that approval of the proposed project would result in
some adverse environmental impacts; however, most of these impacts
would be reduced to less-than-significant levels with the
implementation of Algonquin's proposed mitigation and the additional
measures recommended in the final EIS.
    The U.S. Environmental Protection Agency, the U.S. Army Corps of
Engineers, and the U.S. Department of Transportation's Pipeline and
Hazardous Materials Safety Administration participated as cooperating
agencies in the preparation of the EIS. Cooperating agencies have
jurisdiction by law or special expertise with respect to resources
potentially affected by the proposal and participate in the NEPA
analysis. Although the cooperating agencies provided input to the
conclusions and recommendations presented in the final EIS, the
agencies will present their own conclusions and recommendations in
their respective records of decision or determinations for the AIM
Project.
    The final EIS addresses the potential environmental effects of the
construction and operation of about 37.4 miles of pipeline composed of
the following facilities:
     Replacement of 26.3 miles of existing pipeline with a 16-
and 42-inch-diameter pipeline;
     extension of an existing loop \1\ pipeline with about 3.3
miles of additional 12- and 36-inch-diameter pipeline within
Algonquin's existing right-of-way; and
---------------------------------------------------------------------------

    \1\ A pipeline loop is a segment of pipe constructed parallel to
an existing pipeline to increase capacity.
---------------------------------------------------------------------------

     installation of about 7.8 miles of new 16-, 24-, and 42-
inch-diameter pipeline.
    The AIM Project's proposed aboveground facilities consist of
modifications to six existing compressor stations, to add a total
81,620 horsepower, in New York, Connecticut, and Rhode Island.
Algonquin also proposes to abandon four existing compressor units for a
total of 10,800 horsepower at one compressor station in New York.
    The FERC staff mailed copies of the final EIS to federal, state,
and local government representatives and agencies; elected officials;
environmental and public interest groups; Native American tribes;
potentially affected landowners and other interested individuals and
groups; newspapers and libraries in the area of the project; and
parties to this proceeding. Paper copy versions of this final EIS were
mailed to those specifically requesting them; all others received a CD
version. However, we note that due to its voluminous size, the comment
responses are provided as an electronic-only volume (Volume II) on a CD
that was mailed to the entire mailing list. In addition, the final EIS
is available for public viewing on the FERC's Web site (www.ferc.gov)
using the eLibrary link. A limited number of copies are available for
distribution and public inspection at: Federal Energy Regulatory
Commission, Public Reference Room, 888 First Street NE., Room 2A,
Washington, DC 20426,<PHONE_NUMBER>.
    In accordance with the Council on Environmental Quality's (CEQ)
regulations implementing the NEPA, no agency decision on a proposed
action may be made until 30 days after the U.S. Environmental
Protection Agency publishes a notice of availability of a final EIS.
However, the CEQ regulations provide an exception to this rule when an
agency decision is subject to a formal internal appeal process that
allows other agencies or the public to make their views known. In such
cases, an agency decision may be made at the same time the notice of
the final EIS is published, allowing both periods to run concurrently.
The Commission decision for this proposed action is subject to a 30-day
rehearing period.
    Additional information about the proposed project is available from
the Commission's Office of External Affairs, at (866) 208-FERC, or on
the FERC Web site (www.ferc.gov) using the eLibrary link. Click on the
eLibrary link, click on ``General Search,'' and enter the docket number
excluding the last three digits in the Docket Number field (i.e., CP14-
96). Be sure you have selected an appropriate date range. For
assistance, please contact FERC Online Support at
<EMAIL_ADDRESS>or toll free at<PHONE_NUMBER>; for TTY,
contact<PHONE_NUMBER>. The eLibrary link also provides access to the
texts of formal documents issued by the Commission,

such as orders, notices, and rulemakings.
    In addition, the Commission offers a free service called
eSubscription that allows you to keep track of all formal issuances and
submittals in specific dockets. This can reduce the amount of time you
spend researching proceedings by automatically providing you with
notification of these filings, document summaries, and direct links to
the documents. Go to www.ferc.gov/docs-filing/esubscription.asp.

    Dated: January 23, 2015.
Kimberly D. Bose,
Secretary.
[FR Doc. 2015-01730 Filed 1-29-15; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 83, Number 193 (Thursday, October 4, 2018)]
[Rules and Regulations]
[Pages 50022-50024]
[FR Doc No: 2018-21473]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R04-OAR-2017-0395; FRL-9984-89-Region 4]

Air Plan Approval; TN; Revisions to Ambient Air Quality Standards

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: The Environmental Protection Agency (EPA) is taking final
action to approve a portion of a revision to the Chattanooga/Hamilton
County portion of the Tennessee State Implementation Plan (SIP)
submitted by the State of Tennessee through the Tennessee Department of
Environment and Conservation (TDEC) on behalf of Chattanooga/Hamilton
County Air Pollution Control Bureau (Chattanooga/Hamilton County) on
June 25, 2008. The changes to the SIP that EPA is taking final action
to approve include changes to Chattanooga/Hamilton County's air quality
standards for carbon monoxide, lead, nitrogen dioxide, particulate
matter, ozone, and sulfur dioxide to reflect the current National
Ambient Air Quality Standards (NAAQS). The portions of the SIP revision
that EPA is approving are consistent with the requirements of the Clean
Air Act (CAA or Act).

DATES: This rule will be effective November 5, 2018.

ADDRESSES: EPA has established a docket for this action under Docket
Identification No. EPA-R04-OAR-2017-0395. All documents in the docket
are listed on the www.regulations.gov website. Although listed in the
index, some information is not publicly available, i.e., Confidential
Business Information or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available either electronically through www.regulations.gov or in hard
copy at the Air Regulatory Management Section, Air Planning and
Implementation 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 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: Tiereny Bell, Air Regulatory
Management Section, Air Planning and Implementation Branch, Air,
Pesticides and Toxics Management Division, U.S. Environmental
Protection Agency, Region 4, 61 Forsyth Street SW, Atlanta, Georgia
30303-8960. Ms. Bell can be reached by phone at<PHONE_NUMBER> or via
electronic mail at [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Sections 108 and 109 of the CAA govern the establishment, review,
and revision, as appropriate, of the NAAQS to protect public health and
welfare. The CAA requires periodic review of the air quality criteria--
the science upon which the standards are based--and the standards
themselves. EPA's regulatory provisions that govern the NAAQS are found
at 40 CFR part 50--National Primary and Secondary Ambient Air Quality
Standards.
    In a proposed rulemaking published on May 21, 2018 (83 FR 23407),
EPA proposed to approve into the Tennessee SIP a portion of a revision
to Chattanooga/Hamilton County's air quality rules in Chapter 4 of Part
II, Section 4-41, submitted by TDEC on behalf of the Chattanooga/
Hamilton County Air Pollution Control Bureau on June 25, 2008.
Specifically, EPA proposed to approve a new version of Chapter 4 of
Part II, Section 4-41, Rule 21 of the Chattanooga City Code

``Ambient Air Quality Standards,'' \1\ which was updated to be
consistent with the Federal NAAQS in effect at the time of the SIP
submittal in 2008. The details of Tennessee's submission and the
rationale for EPA's action are explained in the proposed rulemaking.
Comments on the proposed rulemaking were due on or before June 20,
2018. EPA did not receive any adverse comments on the proposed action.
EPA is now taking final action to approve the above-referenced
revision.
---------------------------------------------------------------------------

    \1\ EPA will consider the other changes included in Tennessee's
June 25, 2008, SIP revision in a future rulemaking.
---------------------------------------------------------------------------

II. Incorporation by Reference

    In this rule, EPA is finalizing regulatory text that includes
incorporation by reference. In accordance with requirements of 1 CFR
51.5, EPA is finalizing the incorporation by reference of Chattanooga/
Hamilton Regulation Chapter 4 of Part II, Section 4-41, Rule 21,
``Ambient Air Quality Standards,'' State effective on June 11, 2008.
EPA has made, and will continue to make, these materials generally
available through www.regulations.gov and at the EPA Region 4 Office
(please contact the person identified in the ``For Further Information
Contact'' section of this preamble for more information). Therefore,
these materials have been approved by EPA for inclusion in the SIP,
have been incorporated by reference by EPA into that plan, are fully
federally enforceable under sections 110 and 113 of the CAA as of the
effective date of the final rulemaking of EPA's approval, and will be
incorporated by reference in the next update to the SIP compilation.\2\
---------------------------------------------------------------------------

    \2\ See 62 FR 27968 (May 22, 1997).
---------------------------------------------------------------------------

III. Final Action

    EPA is taking final action to approve a change to the Chattanooga/
Hamilton County portion of the Tennessee SIP for Chapter 4 of Part II,
Section 4-41, Rule 21. EPA has evaluated the relevant portion of
Tennessee's June 25, 2008, SIP revision and has determined that it
meets the applicable requirements of the CAA and EPA regulations.

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. See 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. This action merely
approves State law as meeting Federal requirements and does not impose
additional requirements beyond those imposed by State law. For that
reason, this action:
     Is not a significant regulatory action subject to review
by the Office of Management and Budget under Executive Orders 12866 (58
FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
     Is not an Executive Order 13771 (82 FR 9339, February 2,
2017) regulatory action because SIP approvals are exempted under
Executive Order 12866;
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    The SIP is not approved to apply on any Indian reservation land or
in any other area where EPA or an Indian tribe has demonstrated that a
tribe has jurisdiction. In those areas of Indian country, the rule does
not have tribal implications as specified by Executive Order 13175 (65
FR 67249, November 9, 2000), nor will it impose substantial direct
costs on tribal governments or preempt tribal law.
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this action and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by December 3, 2018. Filing a petition for
reconsideration by the Administrator of this final rule does not affect
the finality of this action for the purposes of judicial review nor
does it extend the time within which a petition for judicial review may
be filed, and shall not postpone the effectiveness of such rule or
action. This action may not be challenged later in proceedings to
enforce its requirements. See section 307(b)(2).

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Carbon monoxide,
Incorporation by reference, Lead, Nitrogen dioxide, Ozone, Particulate
matter, Reporting and recordkeeping requirements, Sulfur oxides,
Volatile organic compounds.

    Dated: September 19, 2018.
Onis ``Trey'' Glenn, III,
Regional Administrator, Region 4.

    40 CFR part 52 is amended as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

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

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

Subpart RR--Tennessee

0
2. In Sec.  52.2220(c), Table 4 is amended under the heading ``Article
II. Section 4-41 Rules, Regulations, Criteria, Standards'' by revising
the entry for ``Section 4-41 Rule 21'' to read as follows:

Sec.  52.2220  Identification of plan.

* * * * *
    (c) * * *

                                  Table 4--EPA Approved Chattanooga Regulations
----------------------------------------------------------------------------------------------------------------
          State section              Title/subject     Adoption date    EPA approval date       Explanation
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
                        Article II. Section 4-41 Rules, Regulations, Criteria, Standards
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
Section 4-41 Rule 21............  Ambient Air              6/11/2008   10/4/2018, [Insert  .....................
                                   Quality Standards.                   citation of
                                                                        publication].

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

* * * * *
[FR Doc. 2018-21473 Filed 10-3-18; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 84, Number 168 (Thursday, August 29, 2019)]
[Notices]
[Pages 45565-45568]
[FR Doc No: 2019-18626]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-86744; File No. SR-CBOE-2019-049]

Self-Regulatory Organizations; Cboe Exchange, Inc.; Notice of
Filing of a Proposed Rule Change Relating To Make Permanent Certain
Options Market Rules That Are Linked to the Equity Market Plan To
Address Extraordinary Market Volatility

August 23, 2019.
    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 August 21, 2019, 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. (``Cboe'' or the ``Exchange'') is filing with
the Securities and Exchange Commission (the ``Commission'') to make
permanent certain options market rules that are linked to the equity
market Plan to Address Extraordinary Market Volatility. The text of the
proposed rule change is attached [sic] as 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
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The purpose of the proposed rule change is to make permanent
certain options market rules in connection with the equity market Plan
to Address Extraordinary Market Volatility (the ``Limit Up-Limit Down
Plan'' or the ``Plan''). This change is being proposed in connection
with the recently approved amendment to the Limit Up-Limit Down Plan
that allows the Plan to continue to operate on a permanent basis
(``Amendment 18'').\3\
---------------------------------------------------------------------------

    \3\ See Securities Exchange Act Release No. 85623 (April 11,
2019), 84 FR 16086 (April 17, 2019) (Order Approving Amendment No.
18).
---------------------------------------------------------------------------

    In an attempt to address extraordinary market volatility in NMS
Stocks, and, in particular, events like the severe volatility on May 6,
2010, U.S. national securities exchanges and the Financial Industry
Regulatory Authority, Inc. (collectively, ``Participants'') drafted the
Plan pursuant to Rule 608 of Regulation NMS under the Act.\4\ On May
31, 2012, the Commission approved the Plan, as amended, on a one-year
pilot basis.\5\ Though the Plan was primarily designed for equity
markets, the Exchange believed it would, indirectly, potentially impact
the options markets as well. Thus, the Exchange has previously adopted
and amended Rules 6.3A, 6.3B and Interpretation and Policy .01 to Rule
6.25 to ensure the option markets were not harmed as a result of the
Plan's implementation and implemented such rules on a pilot basis that
has coincided with the pilot period for the Plan (collectively, the
``Options Pilots'').\6\ Rule 6.3A essentially serves as a roadmap for
the Exchange's universal changes due to the implementation of the Plan,
Rule 6.3B provides for trading halts whenever a market-wide trading
halt is initiated due to extraordinary market conditions pursuant to
the Plan, and Rule 6.25.01 provides that transactions executed during a
limit or straddle state are not subject to the obvious and catastrophic
error rules. A limit or straddle state occurs when at least one side of
the National Best Bid (``NBB'') or Offer (``NBO'') bid/ask is priced at
a non-tradable level. Specifically, a straddle state exists when the
NBB is below the lower price band while the NBO is inside the prices
band or when the NBO is above the upper price band and the NBB is
within the band, while a limit state occurs when the NBO equals the
lower price band (without crossing the NBB), or the NBB equals the
upper price band (without crossing the NBO). The Exchange adopted the
Options Pilots to protect investors because when an underlying security
is in a limit or straddle state, there will not be a reliable price for
the security to serve as a benchmark for the price of the option.
Specifically, the Exchange adopted Rule 6.25.01 because the application
of the obvious and catastrophic error rules would be impracticable
given the potential for lack of a reliable NBBO in the options market
during limit and straddle states. When adjusting or busting a trade
pursuant to the obvious error rule, the determination of theoretical
value of a trade generally references the NBB (for erroneous sell
transactions) or NBO (for erroneous buy transactions) just prior to the
trade in question, and is therefore not reliable when at least one side
of the NBBO is priced at a non-tradeable level, as is the case in limit
and straddle states. In such a situation, determining theoretical value
may often times be a very subjective rather than an objective
determination and could give rise to additional uncertainty and
confusion for investors. As a result, application of the obvious and
catastrophic error rules would be impracticable given the lack of a
reliable NBBO in the options market during limit and straddle states,
and may produce undesirable effects or unanticipated consequences. The
Exchange adopted additional measures via other Options Pilot rules that
are designed to protect investors during limit and straddle states. For
example, the Exchange will reject market orders and not elect stop
orders \7\ during a

Limit Up-Limit Down state to ensure that only those orders with a limit
price will be executed during a limit or straddle state given the
uncertainty of market prices during such a state. Additionally, the
Exchange will initiate a trading halt whenever a market-wide trading
halt is initiated, which ensures that investors have an opportunity to
become aware of and respond to significant price movements.
Furthermore, the Exchange believes that eliminating the application of
obvious error rules during a limit or straddle state eliminates the re-
evaluation of a transaction executed during such a state that could
potentially create an unreasonable adverse selection opportunity due to
lack of a reliable reference price on one side of the market or another
and discourage participants from providing liquidity during limit and
straddle states, which is contrary to the goal in limiting
participants' adverse selection with the application of the obvious
error rule during normal trading states. For these reasons, the
Exchange believes the Options Pilots are designed to add certainty on
the options markets, which encourages more investors to participate in
light of the changes associated with the Plan. The Plan was originally
implemented on a pilot-basis in order to allow the public, the
participating exchanges, and the Commission to assess the operation of
the Plan and whether the Plan should be modified prior to approval on a
permanent basis. As stated, the Exchange adopted the Option Pilots to
coincide with this pilot; to continue the protections therein while the
industry gains further experience operating the Plan.
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    \4\ See Securities Exchange Act Release No. 64547 (May 25,
2011), 76 FR 31647 (June 1, 2011) (File No. 4-631).
    \5\ See Securities and Exchange Act Release No. 67091 (May 31,
2012) 77 FR 33498 (June 6, 2012).
    \6\ See Securities Exchange Act Release Nos. 69328 (April 5,
2013), 78 FR 21642 (April 11, 2013) (SR-CBOE-2013-030) (amending
certain options rules to coincide with the pilot period for the
Plan, including Rule 6.3A and Rule 6.25); 65438 (September 28,
2011), 76 FR 61447 (October 4, 2011) (SR-CBOE-2011-087) (amending
Rule 6.3B for determining when to halt trading in all stocks and
stock options due to extraordinary market volatility); 68770
(January 30, 2013), 78 FR 8211 (February 5, 2013) (SR-CBOE-2013-011)
(amending Rule 6.3B to delay the operative date of the pilot to
coincide with the initial date of operations of the Plan); and 85616
(April 11, 2019), 84 FR 16093 (April 17, 2019) (SR-CBOE-2019-020)
(proposal to extend the pilot for certain options pilots).
    \7\ This includes rules in connection with special handling for
market orders, market-on-close orders, stop orders, and stock-option
orders, as well as for certain electronic order handling features in
a Limit Up-Limit Down state, the obvious error rules, and providing
that the Exchange will not require Market-Makers to quote in series
of options when the underlying security is in a Limit Up-Limit Down
state.
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    In connection with the order approving the establishment of the
obvious error pilot, as well as the extensions of the obvious error
pilot, the Exchange committed to submit monthly data regarding the
program and to submit an overall analysis of the obvious error pilot in
conjunction with the data submitted under the Plan and any other data
as requested by the Commission. Pursuant to a rule filing, approved on
April 3, 2014, each month, the Exchange committed to provide the
Commission, and the public, a dataset containing the data for each
straddle and limit state in optionable stocks that had at least one
trade on the Exchange.\8\ The Exchange has continued to provide the
Commission with this data on a monthly basis from October 2015. For
each trade on the Exchange, the Exchange provides (a) the stock symbol,
option symbol, time at the start of the straddle or limit state, an
indicator for whether it is a straddle or limit state, and (b) for the
trades on the Exchange, the executed volume, time-weighted quoted bid-
ask spread, time-weighted average quoted depth at the bid, time-
weighted average quoted depth at the offer, high execution price, low
execution price, number of trades for which a request for review for
error was received during straddle and limit states, an indicator
variable for whether those options outlined above have a price change
exceeding 30% during the underlying stock's limit or straddle state
compared to the last available option price as reported by OPRA before
the start of the limit or straddle state. In addition, to help evaluate
the impact of the pilot program, the Exchange has provided to the
Commission, and the public, assessments relating to the impact of the
operation of the obvious error rules during limit and straddle states
including: (1) An evaluation of the statistical and economic impact of
limit and straddle states on liquidity and market quality in the
options markets, and (2) an assessment of whether the lack of obvious
error rules in effect during the straddle and limit states are
problematic. The Exchange has concluded that the obvious error pilot
does not negatively impact market quality during normal market
conditions,\9\ and that there has been insufficient data to assess
whether a lack of obvious error rules is problematic, however, the
Exchange believes the continuation of Rule 6.25.01 functions to protect
against any unanticipated consequences in the options markets during a
limit or straddle state and add certainty on the options markets.
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    \8\ See Securities Exchange Act Release No. 71857 (April 3,
2014), 79 FR 19678 (April 9, 2014) (SR-CBOE-2014-033); see also Cboe
Global Markets, LULD Limit and Straddle Reports, available at http://markets.cboe.com/us/options/market_statistics/luld_reports/?mkt=opt.
    \9\ See also Cboe Global Markets, LULD Limit and Straddle
Reports, available at http://markets.cboe.com/us/options/market_statistics/luld_reports/?mkt=opt. During the most recent
Review Period the Exchange did not receive any obvious error review
requests for Limit Up-Limit Down trades, and Limit Up-Limit Down
trade volume accounted for nominal overall trade volume.
---------------------------------------------------------------------------

    The Commission recently approved the Plan on a permanent basis
(Amendment 18).\10\ In connection with this approval, the Exchange now
proposes to amend Exchange Rules 6.3A, 6.3B and Interpretation and
Policy .01 to Rule 6.25 that currently implement the provisions of the
Plan on a pilot basis to eliminate the pilot basis, which effectiveness
expires on October 18, 2019, and to make such rules permanent. In its
approval order to make the Plan permanent, the Commission recognized
that, as a result of the Participants' and industry analysis of the
Plan's operation, the Limit Up-Limit Down mechanism effectively
addresses extraordinary market volatility. Indeed, the Plan benefits
markets and market participants by helping to ensure orderly markets,
but also, the Exchange believes, based on the data made available to
the public and the Commission during the pilot period, that the obvious
error pilot does not negatively impact market quality during normal
market conditions.\11\ Rather, the Exchange believes the obvious error
pilot functions to protect against any unanticipated consequences in
the options markets during a limit or straddle state and add certainty
on the options markets. The Exchange also believes the other Options
Pilots rules provide additional measures designed to protect investors
during limit and straddle states. For example, the Exchange will reject
market orders and not elect stop orders \12\ during a Limit Up-Limit
Down state to ensure that only those orders with a limit price will be
executed during a limit or straddle state given the uncertainty of
market prices during such a state. In addition to this, the Exchange
will initiate a trading halt whenever a market-wide trading halt is
initiated, which ensures that investors have an opportunity to become
aware of and respond to significant price movements. This removes
impediments to and perfects the mechanism of a free and open market and
national market system by encouraging more investors to participate in
light of the changes associated with the Plan. The Exchange believes
that if approved on a permanent basis, the Options Pilots would
permanently provide investors with the above-described additional
certainty of market prices and mitigation of unanticipated consequences
and unreasonable adverse selection risk during limit and straddle
states.
---------------------------------------------------------------------------

    \10\ See supra note 3.
    \11\ See supra note 9.
    \12\ See supra note 7.
---------------------------------------------------------------------------

    The Exchange understands that the other national securities
exchanges will also file similar proposals to make permanent their
respective pilot programs. Since the Commission's approval of Amendment
18 allowing the Plan to operate on a permanent basis, the Exchange and
other national

securities exchanges have determined that no further amendments should
be made to the Options Pilots; \13\ the current Options Pilots
effectively address extraordinary market volatility, are reasonably
designed to comply with the requirements of the Plan, facilitate
compliance with the Plan and should now operate on a permanent basis,
consistent with the Plan. The Exchange does not propose any substantive
or additional changes to Exchange Rules 6.3A, 6.3B or Interpretation
and Policy .01 to Rule 6.25.
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    \13\ See Securities Exchange Act Release No. 85616 (April 11,
2019), 84 FR 16093 (April 17, 2019) (SR-CBOE-2019-020) (proposal to
extend the pilot for certain options market rules linked to the
Plan).
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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.\14\ Specifically, the
Exchange believes the proposed rule change is consistent with the
Section 6(b)(5) \15\ 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 the
Section 6(b)(5) \16\ requirement that the rules of an exchange not be
designed to permit unfair discrimination between customers, issuers,
brokers, or dealers.
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    \14\ 15 U.S.C. 78f(b).
    \15\ 15 U.S.C. 78f(b)(5).
    \16\ Id.
---------------------------------------------------------------------------

    In particular, the Exchange believes that the proposed rule
supports the objectives of perfecting the mechanism of a free and open
market and the national market system because it promotes transparency
and uniformity across markets concerning rules for options markets
adopted to coincide with the Plan. The Exchange believes that
eliminating the pilot basis for the Options Pilots and making such
rules permanent facilitates compliance with the Plan by adding
certainty to the markets during periods of market volatility, which has
been approved and found by the Commission to be reasonably designed to
prevent potentially harmful price volatility in NMS Stocks. It has been
determined by the Commission that the Plan benefits markets and market
participants by helping to ensure orderly markets, and, based on the
data made available to the public and the Commission during the pilot
period for Rule 6.25.01, the Plan does not negatively impact options
market quality during normal market conditions. Rather, the Plan, as it
is implemented under the obvious error pilot, functions to protect
against any unanticipated consequences in the options markets during a
limit or straddle state and add certainty on the options markets.
During a limit or straddle state, determining theoretical value of an
option may be a subjective rather than an objective determination given
the lack of a reliable NBBO, which may create an unreasonable adverse
selection opportunity and discourage participants from providing
liquidity during limit and straddle states. Therefore, the Exchange
believes eliminating obvious error review in such states would, in
turn, eliminate uncertainty and confusion for investors and benefit
investors by encouraging more participation in light of the changes
associated with the Plan. As stated, the Exchange believes the other
Options Pilots rules provide additional measures designed to protect
investors during limit and straddle states. For example, the Exchange
will reject market orders and not elect stop orders \17\ during a Limit
Up-Limit Down state to ensure that only those orders with a limit price
will be executed during a limit or straddle state given the uncertainty
of market prices during such a state. Additionally, the Exchange will
initiate a trading halt whenever a market-wide trading halt is
initiated, which ensures that investors have an opportunity to become
aware of and respond to significant price movements. Accordingly, the
Exchange believes that making the Options Pilots permanent will further
the goals of investor protection and fair and orderly markets as the
rules effectively address extraordinary market volatility pursuant to
the Plan.
---------------------------------------------------------------------------

    \17\ See supra note 7.
---------------------------------------------------------------------------

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

    The Exchange does not believe that the proposed rule change would
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act. The proposed rule change is
necessary to reflect that the Plan no longer operates as a pilot and
has been approved to operate on a permanent basis by the Commission. As
such, Exchange Rules 6.3A, 6.3B or Interpretation and Policy .01 to
Rule 6.25, which implement protections in connection with the Plan,
should be amended to operate on a permanent basis. The Exchange
understands that the other national securities exchanges will also file
similar proposals to make permanent their respective pilot programs.
Thus, the proposed rule change will help to ensure consistency across
market centers without implicating any competitive issues.

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

    Within 45 days of the date of publication of this notice in the
Federal Register or within such longer period up to 90 days (i) as the
Commission may designate if it finds such longer period to be
appropriate and publishes its reasons for so finding or (ii) as to
which the self-regulatory organization consents, the Commission will:
    (A) By order approve or disapprove such proposed rule change, or
    (B) institute proceedings to determine whether the proposed rule
change should be disapproved.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-CBOE-2019-049 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-2019-049. 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-2019-049, and should be submitted on or before September 19, 2019.
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    \18\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\18\
Jill M. Peterson,
Assistant Secretary.
[FR Doc. 2019-18626 Filed 8-28-19; 8:45 am]
BILLING CODE 8011-01-P