[Federal Register Volume 79, Number 15 (Thursday, January 23, 2014)]
[Notices]
[Page 3826]
[FR Doc No: 2014-01219]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0663]

Agency Information Collection Activities; Announcement of Office
of Management and Budget Approval; Investigational New Drug Safety
Reporting Requirements for Human Drug and Biological Products and
Safety Reporting Requirements for Bioavailability and Bioequivalence
Studies in Humans

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a
collection of information entitled ``Investigational New Drug Safety
Reporting Requirements for Human Drug and Biological Products and
Safety Reporting Requirements for Bioavailability and Bioequivalence
Studies in Humans'' has been approved by the Office of Management and
Budget (OMB) under the Paperwork Reduction Act of 1995.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville,
MD 20850<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: On November 13, 2013, the Agency submitted a
proposed collection of information entitled ``Investigational New Drug
Safety Reporting Requirements for Human Drug and Biological Products
and Safety Reporting Requirements for Bioavailability and
Bioequivalence Studies in Humans'' to OMB for review and clearance
under 44 U.S.C. 3507. An Agency may not conduct or sponsor, and a
person is not required to respond to, a collection of information
unless it displays a currently valid OMB control number. OMB has now
approved the information collection and has assigned OMB control number
0910-0672. The approval expires on December 31, 2016. A copy of the
supporting statement for this information collection is available on
the Internet at http://www.reginfo.gov/public/do/PRAMain.

    Dated: January 16, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-01219 Filed 1-22-14; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register: April 8, 2009 (Volume 74, Number 66)]
[Rules and Regulations]
[Page 15865-15869]
[DOCID:fr08ap09-12]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2008-0762; FRL-8408-7]

Bacillus subtilis MBI 600; Exemption from the Requirement of a
Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of the biofungicide, Bacillus subtilis MBI
600, in or on all food commodities, including residues resulting from
post-harvest uses, when applied/used in accordance with good
agricultural practices. Becker Underwood, Inc. submitted a petition to
EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting
an amendment to expand the existing exemption from the requirement of a
tolerance. This regulation eliminates the need to establish a maximum
permissible level for residues of Bacillus subtilis MBI 600 in or on
all food commodities.

DATES: This regulation is effective April 8, 2009. Objections and
requests for hearings must be received on or before June 8, 2009, and
must be filed in accordance with the instructions provided in 40 CFR
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2008-0762. All documents in the
docket are listed in the docket index available at http://
www.regulations.gov. Although listed in the index, some information is
not publicly available, e.g., Confidential Business Information (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 in the electronic
docket at http://www.regulations.gov, or, if only available in hard
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket Facility telephone number is (703)
305-5805.

FOR FURTHER INFORMATION CONTACT: Denise Greenway, Biopesticides and
Pollution Prevention Division (7511P), Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather provides
a guide

for readers regarding entities likely to be affected by this action.
Other types of entities not listed in this unit could also be affected.
The North American Industrial Classification System (NAICS) codes have
been provided to assist you and others in determining whether this
action might apply to certain entities. If you have any questions
regarding the applicability of this action to a particular entity,
consult the person listed under FOR FURTHER INFORMATION CONTACT.

B. How Can I Access Electronic Copies of this Document?

    In addition to accessing electronically available documents at
http://www.regulations.gov, you may access this Federal Register
document electronically through the EPA Internet under the ``Federal
Register'' listings at http://www.epa.gov/fedrgstr. You may also access
a frequently updated electronic version of 40 CFR part 180 through the
Government Printing Office's e-CFR site at http://www.gpoaccess.gov/
ecfr.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, 21 U.S.C. 346a, any person may file
an objection to any aspect of this regulation and may also request a
hearing on those objections. The EPA procedural regulations which
govern the submission of objections and requests for hearings appear in
40 CFR part 178. You must file your objection or request a hearing on
this regulation in accordance with the instructions provided in 40 CFR
part 178. To ensure proper receipt by EPA, you must identify docket ID
number EPA-HQ-OPP-2008-0762 in the subject line on the first page of
your submission. All requests must be in writing, and must be mailed or
delivered to the Hearing Clerk on or before June 8, 2009.
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit your copies, identified by docket ID
number EPA-HQ-OPP-2008-0762, by one of the following methods.
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket Facility's normal hours of operation (8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays).
Special arrangements should be made for deliveries of boxed
information. The Docket Facility telephone number is<PHONE_NUMBER>.

II. Background and Statutory Findings

    In the Federal Register of November 14, 2008 (73 FR 67512) (FRL-
8388-3), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance
petition (PP 8F7368) by Becker Underwood, Inc., 801 Dayton Ave., P. O.
Box 667, Ames, IA 50010. The petition requested that 40 CFR 180.1128 be
amended by expanding the existing exemption from the requirement of a
tolerance for the biofungicide Bacillus subtilis MBI 600 to cover
residues in or on all food commodities, including residues resulting
from post-harvest uses. The notice included a summary of the petition
prepared by the petitioner Becker Underwood, Inc.
    Previously, on June 8, 1994 (59 FR 29543) (FRL-4865-8), EPA issued
a final rule granting an exemption from the requirement of a tolerance
for residues of Bacillus subtilis MBI 600 in or on all raw agricultural
commodities when applied as a seed treatment on seeds used for growing
agricultural crops. In submitting this current petition (i.e., 8F7368),
Becker Underwood, Inc. is relying on the data previously submitted by
another company, Gustafson, Inc., in support of the existing tolerance
exemption for Bacillus subtilis MBI 600. These data were previously
summarized by EPA in the June 8, 1994, final rule. On July 18, 2002,
EPA issued a Tolerance Reassessment Decision in which it found that the
existing tolerance exemption for Bacillus subtilis MBI 600 continues to
meet the FQPA safety standard. This determination in 2002 was based on
EPA's review of the data on which Becker Underwood, Inc., is now
relying in connection with this action.
    There was one comment received in response to the notice of filing.
The commenter expressed dissatisfaction with the level of safety EPA
provides to Americans. Pursuant to its authority under the FFDCA, EPA
conducted a comprehensive assessment of Bacillus subtilis MBI 600,
including a review of studies addressing acute oral, pulmonary and
intravenous injection toxicity/pathogenicity; acute dermal toxicity;
primary eye irritation: and skin sensitization. EPA review of these
studies indicated that the active ingredient is not toxic to test
animals when administered via the oral, pulmonary, intravenous or
dermal routes of exposure. In addition, the active ingredient was not
infective or pathogenic to test animals when administered via the oral,
pulmonary or intravenous routes. Moreover, no reports of
hypersensitivity have been recorded in personnel working with this
organism. Based on these data, the Agency has concluded that there is a
reasonable certainty that no harm will result from dietary exposure to
residues of Bacillus subtilis MBI 600 in or on all food commodities,
including residues resulting from post-harvest uses. Thus, under the
standard in FFDCA section 408(c)(2), an exemption from the requirement
of a tolerance is appropriate.
    Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an
exemption from the requirement for a tolerance (the legal limit for a
pesticide chemical residue in or on a food) only if EPA determines that
the exemption is ``safe.'' Section 408(c)(2)(A)(ii) of FFDCA defines
``safe'' to mean that ``there is a reasonable certainty that no harm
will result from aggregate exposure to the pesticide chemical residue,
including all anticipated dietary exposures and all other exposures for
which there is reliable information.'' This includes exposure through
drinking water and in residential settings, but does not include
occupational exposure. Pursuant to section 408(c)(2)(B) of FFDCA, in
establishing or maintaining in effect an exemption from the requirement
of a tolerance, EPA must take into account the factors set forth in
section 408(b)(2)(C) of FFDCA, which require EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. . .
.'' Additionally, section 408(b)(2)(D) of FFDCA requires that the
Agency consider ``available information concerning the cumulative
effects of a particular pesticide's residues'' and ``other substances
that have a common mechanism of toxicity.''
    EPA performs a number of analyses to determine the risks from
aggregate

exposure to pesticide residues. First, EPA determines the toxicity of
pesticides. Second, EPA examines exposure to the pesticide through
food, drinking water, and through other exposures that occur as a
result of pesticide use in residential settings.

III. Toxicological Profile

    Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the
available scientific data and other relevant information in support of
this action and considered its validity, completeness, and reliability
and the relationship of this information to human risk. EPA has also
considered available information concerning the variability of the
sensitivities of major identifiable subgroups of consumers, including
infants and children.
    Toxicological data on the active ingredient were previously
submitted to support the existing exemption from the requirement of a
tolerance for residues of Bacillus subtilis MBI 600 resulting from its
use in the treatment of seeds used for growing agricultural crops, and
to support various pesticide product registrations held by the
petitioner. The previously submitted studies on the active ingredient
include the following:
    An acceptable acute oral toxicity/pathogenicity study performed in
rats (MRID 419074-02) demonstrated the lack of mammalian toxicity at
high levels of exposure to Bacillus subtilis MBI 600. In this study,
Bacillus subtilis MBI 600 was not toxic, infective nor pathogenic to
rats given an oral dose of 2 x 108 colony forming units
(CFU) per animal. The study resulted in a classification of Toxicity
Category IV for this strain of Bacillus subtilis.
    An acceptable acute pulmonary toxicity/pathogenicity study in rats
(MRID 419074-04) demonstrated that Bacillus subtilis MBI 600 was
neither toxic, pathogenic nor infective to rats dosed intratracheally
with 3.4 x 108 CFU of the test material. The study resulted
in a classification of Toxicity Category IV for this strain of Bacillus
subtilis.
    An acceptable acute intravenous injection toxicity/pathogenicity
study in rats (MRID 419074-05) demonstrated that Bacillus subtilis MBI
600 was neither toxic, pathogenic nor infective to rats dosed
intravenously with approximately 4 x 107 CFU of the test
material. Although the microbe was detected in every organ tested, the
test material displayed a distinct pattern of clearance. The study
resulted in a classification of Toxicity Category IV for this strain of
Bacillus subtilis.
    An acceptable acute dermal toxicity study in rabbits (MRID 419074-
03) demonstrated that Bacillus subtilis MBI 600 was not toxic to
rabbits when a single 5 x 1010 dose was administered
dermally. The study resulted in a classification of Toxicity Category
IV for this strain of Bacillus subtilis.
    An acceptable primary eye irritation study in rabbits (MRID 419074-
06) demonstrated that Bacillus subtilis MBI 600 produced a slight
ocular irritation when a single 0.1 gram ocular dose was administered.
Ocular irritation dissipated by day 4. The study resulted in a
classification of Toxicity Category IV for this strain of Bacillus
subtilis.
    A supplemental skin sensitization test resulted in an overall
moderate reaction in guinea pigs 24 to 78 hours post-treatment.
However, an acceptable dermal sensitization study, conducted with an
end use formulation, demonstrated no irritation 2 weeks after
sensitization and treatment using 400 milligrams of test material. As a
result, the product was determined to not be a dermal sensitizer.
Furthermore, in the nearly 15 years since its initial registration as
an active ingredient, there have been no hypersensitivity reports
associated with Bacillus subtilis MBI 600 pesticide products.

IV. Aggregate Exposures

    In examining aggregate exposure, section 408 of FFDCA directs EPA
to consider available information concerning exposures from the
pesticide residue in food and all other non-occupational exposures,
including drinking water from ground water or surface water and
exposure through pesticide use in gardens, lawns, or buildings
(residential and other indoor uses).

A. Dietary Exposure

    Bacillus subtilis MBI 600 is ubiquitous in the environment,
especially in soils and agricultural environments (indeed, strain MBI
600 of Bacillus subtilis is a naturally-occurring isolate of the genus
Bacillus, originally isolated from faba beans grown at Nottingham
University School of Agriculture in the United Kingdom). As a result,
dietary exposure to background levels of the naturally occurring
microbe likely is already occurring and likely will continue to occur.
Because of its ubiquitous presence in the environment, the Agency
expects there to be no increase in exposure to Bacillus subtilis MBI
600 resulting from the existing and proposed pesticidal uses when
compared to existing exposure to background levels of Bacillus subtilis
MBI 600.
    1. Food. As discussed above, dietary exposure to the naturally
occurring microbe likely is already occurring and likely will continue
to occur. Notably, similar Bacillus subtilis strains are used
internationally in the production of food grade products and in
fermented foods in Japan and Thailand. Reports in the literature
implicating Bacillus subtilis (as distinguished from the specific
strain, Bacillus subtilis MBI 600, at issue in this action) in food-
borne illness do not describe any pathogen or toxin production, but
rather simple spoilage from Bacillus subtilis growth in dough. Such
low-quality dough would not be suitable for bread production by
commercial bakeries and so the Agency considers this particular food
exposure scenario to be unlikely and the risk to be negligible. The
risk posed to adults, infants and children from food-related exposures
to Bacillus subtilis MBI 600 is minimal due to the demonstrated lack of
acute oral toxicity/pathogenicity associated with the microbial
pesticide. Based on the evaluation of the submitted data, there are no
dietary risks that exceed the Agency's level of concern.
    2. Drinking water exposure. Because Bacillus subtilis MBI 600 is
ubiquitous in the environment, exposure to the microbe through drinking
water may already be occurring and likely will continue to occur. While
the proposed and existing use sites do not include direct application
to aquatic environments, the intended use of Bacillus subtilis MBI 600
is treatment of growing crops or seed for the control of plant disease.
If such uses were to result in pesticide spray drift or runoff that
were to reach surface or ground waters, there is the potential for
human exposure to Bacillus subtilis MBI 600 residues, albeit greatly
diluted, in drinking water. Municipal drinking water treatment
processes and deep water wells, however, would both further reduce any
such residues. More importantly, even if oral exposure to this
ubiquitous microbe should occur through drinking water, due to its
demonstrated lack of acute oral toxicity/pathogenicity, the Agency
concludes that there is a reasonable certainty that no harm will result
from such exposure.

B. Other Non-Occupational Exposure

    The pesticide uses of Bacillus subtilis MBI 600, both those
currently allowed and the additional ones being established by this
rule, are limited to commercial agricultural and horticultural
settings. There are no residential uses. Nonetheless, because Bacillus
subtilis MBI 600 is naturally occurring and ubiquitous in the
environment, the potential for non-dietary, non-occupational exposure
to

its residues for the general population, including infants and
children, is likely since populations have probably been previously
exposed (and likely will continue to be exposed) to background levels
of the microbe. However, neither such common human exposures to
Bacillus subtilis MBI 600 naturally present in soils, waters and
plants, nor exposures associated with similar Bacillus subtilis strains
used internationally in producing food-grade products and fermented
foods, have resulted in reports of disease or other effects. Finally,
while the literature includes accounts of Bacillus subtilis infections
in humans (which consistently are reported only in otherwise-
compromised individuals), those reports are most notable for their rare
and exceptional nature.
    EPA's evaluation of the required high-dose Tier I acute toxicity
and pathogenicity tests resulted in the assignment of Toxicity Category
IV (least toxic), and determinations of not infective and not
pathogenic, for all exposure routes. No toxicological end points of
concern were identified. There are no dietary endpoints that exceed the
Agency's Level of Concern (LOC). Therefore, the Agency has determined
that any additional exposure to the microbe resulting from residues
attributable to Bacillus subtilis MBI 600 pesticide use will not result
in additional aggregate non-occupational risk from dermal and
inhalation exposures. This conclusion, based solely on non-occupational
exposures, is consistent with EPA's determination that no occupational
risks exceed the Agency's LOC, meaning that even regular occupational
exposures associated with this active ingredient pose negligible risk.

V. Cumulative Effects

    No mechanism of toxicity in mammals has been identified for
Bacillus subtilis MBI 600. Therefore, no cumulative effect with other
related organisms is anticipated. Because the available data
demonstrate a lack of toxicity/pathogenicity potential for the active
ingredient, adverse dietary effects are unlikely.

VI. Determination of Safety for U.S. Population, Infants and Children

    FFDCA section 408(b)(2)(C), as amended by the Food Quality
Protection Act (FQPA) of 1996, provides that EPA shall assess the
available information about consumption patterns among infants and
children, special susceptibility of infants and children to pesticide
chemical residues, and the cumulative effects on infants and children
of the residues and other substances with a common mechanism of
toxicity. In addition, FFDCA section (b)(2)(C) also provides that EPA
shall apply an additional tenfold margin of safety for infants and
children in the case of threshold effects to account for prenatal and
postnatal toxicity and the completeness of the database, unless EPA
determines that a different margin of safety will be safe for infants
and children.
    Based on the acute toxicity information discussed in Unit III., EPA
concludes that there is a reasonable certainty that no harm will result
to the United States population, including infants and children, from
aggregate exposure to residues of Bacillus subtilis MBI 600. This
includes all anticipated dietary exposures and all other exposures for
which there is reliable information. The Agency has arrived at this
conclusion because the data available on Bacillus subtilis MBI 600
demonstrate a lack of toxicity/pathogenicity potential. Thus, there are
no threshold effects of concern and, as a result, the Agency has
concluded that the additional tenfold margin of safety for infants and
children is unnecessary in this instance. Further, the need to consider
consumption patterns, special susceptibility, and cumulative effects
does not arise when dealing with pesticides with no demonstrated
significant adverse effects.

VII. Other Considerations

A. Endocrine Disruptors

    Bacillus subtilis MBI 600 is a ubiquitous organism in the
environment that is non-toxic to mammals. To date, there is no evidence
to suggest that Bacillus subtilis MBI 600 affects the immune system,
functions in a manner similar to any known hormone, or that it acts as
an endocrine disruptor. Indeed, the submitted toxicity/pathogenicity
studies in rodents indicate that, following several routes of exposure,
the immune system is intact and able to process and clear the active
ingredient. Therefore, it is unlikely that this organism will have
estrogenic or endocrine effects.

B. Analytical Method

    The Agency is establishing an exemption from the requirement of a
tolerance for residues of Bacillus subtilis MBI 600 in or on all food
commodities, including residues resulting from post-harvest uses, for
the reasons stated above. Therefore, the Agency has concluded that an
analytical method is not required for enforcement purposes for
detecting Bacillus subtilis MBI 600 residues resulting from its use as
a pesticide.

C. Codex Maximum Residue Level

    No Codex maximum residue level (MRL) exists for Bacillus subtilis
MBI 600.

VIII. Conclusions

    Based on the toxicity information for Bacillus subtilis MBI 600
that was previously submitted and reviewed, EPA concludes that there is
a reasonable certainty that no harm will result to the U.S. population,
including infants and children, from aggregate exposure to Bacillus
subtilis MBI 600 under reasonably foreseeable circumstances when used
as a microbial pesticide in accordance with its label and good
agricultural practices. This includes all anticipated dietary exposures
and all other exposures for which there is reliable information. As a
result, pursuant to FFDCA sections 408(c) and (d) EPA is establishing
an exemption from the requirement of a tolerance for residues of the
biofungicide Bacillus subtilis MBI 600 in or on all food commodities,
including residues resulting from post-harvest uses, when applied or
used in accordance with good agricultural practices.

IX. Statutory and Executive Order Reviews

    This final rule establishes a tolerance under section 408(d) of
FFDCA in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). Because this final rule has been
exempted from review under Executive Order 12866, this final rule is
not subject to Executive Order 13211, entitled Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
Protection of Children from Environmental Health Risks and Safety Risks
(62 FR 19885, April 23, 1997). This final rule does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any
special considerations under Executive Order 12898, entitled Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under section 408(d) of FFDCA, such as

the tolerance in this final rule, do not require the issuance of a
proposed rule, the requirements of the Regulatory Flexibility Act (RFA)
(5 U.S.C. 601 et seq.) do not apply.
    This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled Federalism (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (65 FR
67249, November 9, 2000) do not apply to this final rule. In addition,
this final rule does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (Public Law 104-4).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272
note).

X. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report to each House of the Congress and to
the Comptroller General of the United States. EPA will submit a report
containing this rule and other required information to the U.S. Senate,
the U.S. House of Representatives, and the Comptroller General of the
United States prior to publication of this final rule in the Federal
Register. This final rule is not a ``major rule'' as defined by 5
U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

    Dated: March 20, 2009.
Janet L. Andersen,
Director, Biopesticides and Pollution Prevention Division, Office of
Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

0
2. Section 180.1128 is revised to read as follows:

Sec.  180.1128  Bacillus subtilis MBI 600; exemption from the
requirement of a tolerance.

    An exemption from the requirement of a tolerance is established for
residues of the biofungicide Bacillus subtilis MBI 600 in or on all
food commodities, including residues resulting from post-harvest uses,
when applied or used in accordance with good agricultural practices.

[FR Doc. E9-7172 Filed 4-7-09; 8:45 am]

BILLING CODE 6560-50-S


[Federal Register Volume 81, Number 154 (Wednesday, August 10, 2016)]
[Notices]
[Pages 52933-52939]
[FR Doc No: 2016-18912]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-78481; File No. SR-IEX-2016-07]

Self-Regulatory Organizations; Investors Exchange LLC; Notice of
Filing and Immediate Effectiveness of Proposed Rule Change To Adopt
Rule 11.340(b) To Set Forth the Requirements for the Collection and
Transmission of Data Pursuant to the Regulation NMS Plan To Implement a
Tick Size Pilot Program

August 4, 2016.
    Pursuant to section 19(b)(1) \1\ of the Securities Exchange Act of
1934 (the ``Act'') \2\ and Rule 19b-4 thereunder,\3\ notice is hereby
given that, on July 28, 2016, the Investors Exchange LLC (``IEX'' or
the ``Exchange'') filed with the Securities and Exchange Commission
(the ``Commission'') the proposed rule change as described in Items I
and II below, which Items have been prepared by the self-regulatory
organization. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 15 U.S.C. 78a.
    \3\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    Pursuant to the provisions of section 19(b)(1) under the Securities
Exchange Act of 1934 (``Act''), and Rule 19b-4 thereunder, Investors
Exchange LLC (``IEX'' or ``Exchange'') is filing with the Securities
and Exchange Commission (``Commission'') a proposed rule change to
amend Rule 11.340, which is currently reserved, to implement the
Regulation NMS Plan to Implement a Tick Size Pilot Program (``Plan'').
Specifically, the Exchange proposes to adopt Rule 11.340(b) to set
forth the requirements for the collection and transmission of data
pursuant to Appendices B and C of the Plan. The proposed rule change is
substantially similar to proposed rule changes recently approved or
published by the Commission for the Bats BZX Exchange, Inc. f/k/a BATS
Exchange, Inc. (``BZX'') to adopt BZX Rule 11.27(b) which also sets
forth requirements for the collection and transmission of data pursuant
to Appendices B and C of the Plan. The Exchange has designated this
proposal as a ``non-controversial'' proposed rule change pursuant to
section 19(b)(3)(A) of the Act and provided the Commission with the
notice required by Rule 19b-4(f)(6)(iii) under the Act. The text of the
proposed rule change is available at the Exchange's Web site at
www.iextrading.com, at the principal office of the Exchange, and at the
Commission's Public Reference Room.

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

    In its filing with the Commission, the self-regulatory organization
included statements concerning the purpose of and basis for the
proposed rule change and discussed any comments it received on the
proposed rule change. The text of these statement may be examined at
the places specified in Item IV below. The self-regulatory organization
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
    On August 25, 2014, NYSE Group, Inc., on behalf of BATS Exchange,
Inc., BATS Y-Exchange, Inc., Chicago Stock Exchange, Inc., EDGA
Exchange, Inc., EDGX Exchange, Inc., Financial Industry Regulatory
Authority, Inc. (``FINRA''), NASDAQ OMX BX, Inc., NASDAQ OMX PHLX LLC,
the Nasdaq Stock Market LLC, New York Stock Exchange LLC (``NYSE''),
NYSE MKT LLC, and NYSE Arca, Inc. (collectively ``Participants''),
filed with the Commission, pursuant to section 11A of the Act \4\ and
Rule 608 of Regulation NMS thereunder,\5\ the Plan to Implement a Tick
Size Pilot Program (``Pilot'').\6\ The Participants filed the Plan to
comply with an order issued by the Commission on June 24, 2014.\7\ The
Plan \8\ was published for comment in the Federal Register on November
7, 2014, and approved by the Commission, as modified, on May 6,
2015.\9\ On November 6, 2015, the Commission granted the Participants
an exemption from implementing the Plan until October 3, 2016.\10\ An
amendment to the Plan adding IEX as a Participant will be filed with
the Commission shortly.
---------------------------------------------------------------------------

    \4\ 15 U.S.C. 78k-1
    \5\ 17 CFR 242.608.
    \6\ See Letter from Brendon J. Weiss, Vice President,
Intercontinental Exchange, Inc., to Secretary, Commission, dated
August 25, 2014.
    \7\ See Securities Exchange Act Release No. 72460 (June 24,
2014), 79 FR 36840 (June 30, 2014).
    \8\ Unless otherwise specified, capitalized terms used in this
rule filing are based on the defined terms of the Plan.
    \9\ See Securities Exchange Act Release No. 74892 (May 6, 2015),
80 FR 27513 (May 13, 2015) (File No. 4-657) (``Approval Order'').
    \10\ See Securities Exchange Act Release No. 76382 (November 6,
2015), 80 FR 70284 (November 13, 2015) (File No. 4-657) (Order
Granting Exemption from Compliance with the National Market System
Plan to Implement a Tick Size Pilot Program).
---------------------------------------------------------------------------

    The Plan is designed to allow the Commission, market participants,
and the public to study and assess the impact of increment conventions
on the liquidity and trading of the common stocks of small-
capitalization companies. Each Participant is required to comply, and
to enforce compliance by its member organizations, as applicable, with
the provisions of the Plan. As is described more fully below, the
proposed rules would require IEX Members \11\ to comply with the
applicable data collection requirements of the Plan.\12\
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    \11\ An IEX Member is ``. . . any registered broker or dealer
that has been admitted to membership in the Exchange. A Member will
have the status of a Member of the Exchange as that term is defined
in Section 3(a)(3) of the Act. Membership may be granted to a sole
proprietor, partnership, corporation, limited liability company, or
other organization that is a registered broker or dealer pursuant to
Section 15 of the Act, and which has been approved by the
Exchange.'' See IEX Rule 1.160(s).
    \12\ The Exchange proposes Supplementary Material .01 to Rule
11.340 to provide that the Rule shall be in effect during a pilot
period to coincide with the pilot period for the Plan (including any
extensions to the pilot period for the Plan).
---------------------------------------------------------------------------

    The Pilot will include stocks of companies with $3 billion or less
in market capitalization, an average daily trading volume of one
million shares or less, and a volume weighted average price of at least
$2.00 for every trading day. The Pilot will consist of a control group
of approximately 1,400 Pilot Securities and three test groups with 400
Pilot Securities in each (selected by a stratified random sampling
process).\13\ During the pilot, Pilot Securities in the control group
will be quoted at the current tick size increment of $0.01 per share
and will trade at the currently permitted increments. Pilot Securities
in the first test group (``Test Group One'') will be quoted in the
$0.05 minimum increments but will continue to trade at any price
increment that is currently permitted.\14\ Pilot Securities in the
second test group (``Test Group Two'') will be quoted in $0.05 minimum
increments and will trade at $0.05 minimum increments subject to a
midpoint exception, a retail investor order exception, and a negotiated
trade exception.\15\ Pilot Securities in the third test group (``Test
Group Three'') will be subject to the same quoting and trading
increments as Test Group Two and also

will be subject to the ``Trade-at'' requirements to prevent price
matching by a market participant that is not displaying at a Trading
Center's ``Best Protected Bid'' or ``Best Protected Offer,'' unless an
enumerated exception applies.\16\ In addition to the exceptions
provided under Test Group Two, an exception for Block Size orders and
exceptions that mirror those under Rule 611 of Regulation NMS \17\ will
apply to the Trade-at requirement.
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    \13\ See Section V of the Plan for identification of Pilot
Securities, including criteria for selection and grouping.
    \14\ See Section VI(B) of the Plan.
    \15\ See Section VI(C) of the Plan.
    \16\ See Section VI(D) of the Plan.
    \17\ 17 CFR 242.611.
---------------------------------------------------------------------------

    In approving the Plan, the Commission noted that the Trading Center
data reporting requirements would facilitate an analysis of the effects
of the Pilot on liquidity (e.g., transaction costs by order size),
execution quality (e.g., speed of order executions), market maker
activity, competition between trading venues (e.g., routing frequency
of market orders), transparency (e.g., choice between displayed and
hidden orders), and market dynamics (e.g., rates and speed of order
cancellations).\18\ The Commission noted that Market Maker
profitability data would assist the Commission in evaluating the
effect, if any, of a widened tick increment on market maker profits and
any corresponding changes in the liquidity of small-capitalization
securities.\19\
---------------------------------------------------------------------------

    \18\ See Approval Order, 80 FR at 27543.
    \19\ Id.
---------------------------------------------------------------------------

Compliance With the Data Collection Requirements of the Plan
    The Plan contains requirements for collecting and transmitting data
to the Commission and to the public.\20\ Specifically, Appendix B.I of
the Plan (Market Quality Statistics) requires Trading Centers \21\ to
submit a variety of market quality statistics, including information
about an order's original size, whether the order was displayable or
not, the cumulative number of orders, the cumulative number of shares
of orders, and the cumulative number of shares executed within specific
time increments, e.g., from 30 seconds to less than 60 seconds after
the time of order receipt. This information shall be categorized by
security, order type, original order size, hidden status, and coverage
under Rule 605.\22\ Appendix B.I of the Plan also contains additional
requirements for market orders and marketable limit orders, including
the share-weighted average spread for executions of orders; the
cumulative number of shares of orders executed with price improvement;
and, for shares executed with price improvement, the share-weighted
average amount per share that prices were improved.
---------------------------------------------------------------------------

    \20\ The Exchange is also required by the Plan to establish,
maintain, and enforce written policies and procedures that are
reasonably designed to comply with applicable quoting and trading
requirements specified in the Plan. The Exchange intends to
separately propose rules that would require compliance by its
Members with the applicable quoting and trading requirements
specified in the Plan, and has reserved paragraph (a) for such
rules.
    \21\ The Plan incorporates the definition of a ``Trading
Center'' from Rule 600(b)(78) of Regulation NMS. Regulation NMS
defines a ``Trading Center'' as ``a national securities exchange or
national securities association that operates an SRO trading
facility, an alternative trading system, an exchange market maker,
an OTC market maker, or any other broker or dealer that executes
orders internally by trading as principal or crossing orders as
agent.'' See 17 CFR 242.600(b).
    \22\ 17 CFR 242.605.
---------------------------------------------------------------------------

    Appendix B.II of the Plan (Market and Marketable Limit Order Data)
requires Trading Centers to submit information relating to market
orders and marketable limit orders, including the time of order
receipt, order type, the order size, the National Best Bid and National
Best Offer (``NBBO'') quoted price, the NBBO quoted depth, the average
execution price-share-weighted average, and the average execution time-
share-weighted average.
    The Plan requires Appendix B.I and B.II data to be submitted by
Participants that operate a Trading Center, and by members of the
Participants that operate Trading Centers. The Plan provides that each
Participant that is a Designated Examining Authority (``DEA'') for a
member of the Participant that operates a Trading Center shall collect
such data in a pipe delimited format, beginning six months prior to the
Pilot Period and ending six months after the end of the Pilot Period.
The Plan also requires the Participant, operating as DEA, to transmit
this information to the SEC within 30 calendar days following month
end.
    The Exchange is therefore proposing Rule 11.340(b) to set forth the
requirements for the collection and transmission of data pursuant to
Appendices B and C of the Plan. Proposed Rule 11.340(b) is
substantially similar to proposed rule changes of BZX that were
recently approved or published by the Commission to adopt BZX Rule
11.27(b) which also sets forth requirements for the collection and
transmission of data pursuant to Appendices B and C of the Plan.\23\
---------------------------------------------------------------------------

    \23\ See Securities Exchange Act Release Nos. 77105 (February
10, 2016), 81 FR 8112 (February 17, 2016) (order approving SR-BATS-
2015-102); and 77310 (March 7, 2016) (notice for comment and
immediate effectiveness of SR-BATS-2016-27).
---------------------------------------------------------------------------

    Proposed Rule 11.340(b)(1) requires that a Member that operates a
Trading Center shall establish, maintain and enforce written policies
and procedures that are reasonably designed to comply with the data
collection and transmission requirements of Items I and II to Appendix
B of the Plan, and a Member that is a Market Maker \24\ shall
establish, maintain and enforce written policies and procedures that
are reasonably designed to comply with the data collection and
transmission requirements of Item IV of Appendix B of the Plan and Item
I of Appendix C of the Plan.
---------------------------------------------------------------------------

    \24\ The Plan defines a Market Maker as ``a dealer registered
with any self-regulatory organization, in accordance with the rules
thereof, as (i) a market maker or (ii) a liquidity provider with an
obligation to maintain continuous, two-sided trading interest.''
---------------------------------------------------------------------------

    Proposed Rule 11.340(b)(2) provides that the Exchange shall collect
and transmit to the SEC the data described in Items I and II of
Appendix B of the Plan relating to trading activity in Pre-Pilot
Securities and Pilot Securities on a Trading Center operated by the
Exchange. The Exchange shall transmit such data to the SEC in a pipe
delimited format, on a disaggregated basis by Trading Center, within 30
calendar days following month end for: (i) Each Pre-Pilot Data
Collection Security for the period beginning six months prior to the
Pilot Period through the trading day immediately preceding the Pilot
Period; and (ii) each Pilot Security for the period beginning on the
first day of the Pilot Period through six months after the end of the
Pilot Period. The Exchange also shall make such data publicly available
on the Exchange Web site on a monthly basis at no charge and will not
identify the Member that generated the data.
    On June 17, 2016 the Commission granted to IEX an application for
registration as a national securities exchange under section 6 of the
Act.\25\ IEX intends to launch exchange operations during a security-
by-security phase-in period scheduled to begin on August 19, 2016.
During the phase-in period, securities will transition from being
available for trading on the Alternative Trading System operated by the
Exchange's affiliate IEX Services LLC (``IEX ATS''), to the Exchange.
Once a security becomes available for trading on the Exchange it will
no longer be available for trading on the IEX ATS.\26\ The IEX ATS
currently reports data for Pilot Securities to FINRA pursuant to FINRA
Rule 6191(b). During the phase-in period, the IEX ATS will continue to
report data to FINRA

for Pilot Securities that have not yet transitioned to the Exchange.
Data for Pilot Securities that have transitioned to the Exchange will
be reported to the SEC pursuant to IEX Rule 11.340(b), as proposed.
Accordingly, reporting for Pilot Securities will take place as
appropriate based on each Pilot Security's status as either available
for trading on the IEX ATS or the Exchange.
---------------------------------------------------------------------------

    \25\ See Securities Exchange Act Release No. 34-78101 (June 17,
2016), 81 FR 41141 (June 23, 2016) (File No. 10-222).
    \26\ See, https://iextrading.com/trading/alerts/2016/028/#exchange-transition for detailed information on the transition from
the IEX ATS to Exchange.
---------------------------------------------------------------------------

    Appendix B.IV (Daily Market Maker Participation Statistics)
requires a Participant to collect data related to Market Maker
participation from each Market Maker engaging in trading activity on a
Trading Center operated by the Participant. The Exchange is therefore
proposing Rule 11.340(b)(3) to gather data about a Market Maker's
participation in Pilot Securities and Pre-Pilot Data Collection
Securities. Proposed Rule 11.340(b)(3)(A) provides that a Member that
is a Market Maker shall collect and transmit to their DEA data relating
to Item IV of Appendix B of the Plan with respect to activity conducted
on any Trading Center in Pilot Securities and Pre-Pilot Data Collection
Securities in furtherance of its status as a registered Market Maker,
including a Trading Center that executes trades otherwise than on a
national securities exchange, for transactions that have settled or
reached settlement date. The proposed rule requires Market Makers to
transmit such data in a format required by their DEA, by 12:00 p.m. EST
on T+4 for: (i) Transactions in each Pre-Pilot Data Collection Security
for the period beginning six months prior to the Pilot Period through
the trading day immediately preceding the Pilot Period; and (ii) for
transactions in each Pilot Security for the period beginning on the
first day of the Pilot Period through six months after the end of the
Pilot Period.
    The Exchange understands that some Members may have a DEA that is
not a Participant to the Plan and that such non-Participant DEA would
not be subject to the Plan's data collection requirements. In such
case, a DEA that is not a Participant of the Plan would not be required
to collect the required data and may not establish procedures for those
Members for which it acts as DEA to report the data required under
subparagraphs (b)(3)(A) of Rule 11.340 and in accordance with Item IV
of Appendix B of the Plan. Therefore, the Exchange proposes to adopt
subparagraph (b)(3)(B) to Rule 11.340 to require a Member that is a
Market Maker whose DEA is not a Participant to the Plan to transmit the
data collected pursuant to paragraph (3)(A) of Rule 11.340(b) to FINRA,
which is a Participant to the Plan and will collect data relating to
Item IV of Appendix B of the Plan on behalf of the Participants. For
Market Makers for which it is the DEA, FINRA issued a Market Maker
Transaction Data Technical Specification to collect data on Pre-Pilot
Data Collection Securities and Pilot Securities from Trading Centers to
comply with the Plan's data collection requirements.\27\
---------------------------------------------------------------------------

    \27\ FINRA members for which FINRA is their DEA should refer to
the Market Maker Transaction Technical Specification on the FINRA
Web site at http://www.finra.org/sites/default/files/market-maker-transaction-data-tech-specs.pdf.
---------------------------------------------------------------------------

    Proposed Rule 11.340(b)(3)(C) provides that the Exchange shall
transmit the data collected by the DEA or FINRA pursuant to Rule
11.340(b)(3)(A) and (B) above relating to Market Maker activity on a
Trading Center operated by the Exchange to the SEC in a pipe delimited
format within 30 calendar days following month end. The Exchange shall
also make such data publicly available on the Exchange Web site on a
monthly basis at no charge and shall not identify the Trading Center
that generated the data.
    Appendix C.I (Market Maker Profitability) requires a Participant to
collect data related to Market Maker profitability from each Market
Maker for which it is the DEA. Specifically, the Participant is
required to collect the total number of shares of orders executed by
the Market Maker; the raw Market Maker realized trading profits, and
the raw Market Maker unrealized trading profits. Data shall be
collected for dates starting six months prior to the Pilot Period
through six months after the end of the Pilot Period. This data shall
be collected on a monthly basis, to be provided in a pipe delimited
format to the Participant, as DEA, within 30 calendar days following
month end. Appendix C.II (Aggregated Market Maker Profitability)
requires the Participant, as DEA, to aggregate the Appendix C.I data,
and to categorize this data by security as well as by the control group
and each Test Group. That aggregated data shall contain information
relating to total raw Market Maker realized trading profits, volume-
weighted average of raw Market Maker realized trading profits, the
total raw Market Maker unrealized trading profits, and the volume-
weighted average of Market Maker unrealized trading profits.
    The Exchange is therefore proposing Rule 11.340(b)(4) to set forth
the requirements for the collection and transmission of data pursuant
to Appendix C.I of the Plan. Proposed Rule 11.340(b)(4)(A) requires
that a Member that is a Market Maker shall collect and transmit to
their DEA the data described in Item I of Appendix C of the Plan, as
modified by Paragraph (b)(5) with respect to executions in Pilot
Securities that have settled or reached settlement date that were
executed on any Trading Center. The proposed rule also requires Members
to provide such data in a format required by their DEA by 12 p.m. EST
on T+4 for executions during and outside of Regular Trading Hours in
each: (i) Pre-Pilot Data Collection Security for the period beginning
six months prior to the Pilot Period through the trading day
immediately preceding the Pilot Period; and (ii) Pilot Security for the
period beginning on the first day of the Pilot Period through six
months after the end of the Pilot Period.
    For the same reasons set forth above for subparagraph (b)(3)(B) to
Rule 11.340, the Exchange proposes to adopt subparagraph (b)(4)(B) to
Rule 11.340 to require a Member that is a Market Maker whose DEA is not
a Participant to the Plan to transmit the data collected pursuant to
paragraph (4)(A) of Rule 11.340(b) to FINRA. As stated above, FINRA is
a Participant to the Plan and is to collect data relating to Item I of
Appendix C of the Plan on behalf of the Participants. For Market Makers
for which it is the DEA, FINRA issued a Market Maker Transaction Data
Technical Specification to collect data on Pre-Pilot Data Collection
Securities and Pilot Securities from Trading Centers to comply with the
Plan's data collection requirements.\28\
---------------------------------------------------------------------------

    \28\ Id.
---------------------------------------------------------------------------

    The Exchange is also adopting a rule setting forth the manner in
which Market Maker participation will be calculated. Item III of
Appendix B of the Plan requires each Participant that is a national
securities exchange to collect daily Market Maker registration
statistics categorized by security, including the following
information: (i) Ticker symbol; (ii) the Participant exchange; (iii)
number of registered market makers; and (iv) the number of other
registered liquidity providers. Therefore, the Exchange proposes to
adopt Rule 11.340(b)(5) providing that the Exchange shall collect and
transmit to the SEC the data described in Item III of Appendix B of the
Plan relating to daily Market Maker registration statistics in a pipe
delimited format within 30 calendar days following month end for: (i)
Transactions in each Pre-Pilot Data Collection Security for the period
beginning six months prior to the Pilot Period through the trading day
immediately preceding the Pilot Period; and (ii) transactions in each
Pilot Security for the period beginning on the first day of the Pilot
Period through six months after the end of the Pilot Period.

The Exchange notes that, as of the date of this filing, it does not
have any registered Market Makers and therefore will not have daily
Market Maker registration statistics to collect or transmit to the SEC
or to FINRA pursuant to Item III of Appendix B of the Plan unless and
until such time as it has registered Market Makers.
    The Exchange is also proposing, through Supplementary Material, to
clarify other aspects of the data collection requirements.\29\ Proposed
Supplementary Material .02 relates to the use of the retail investor
order flag for purposes of Appendix B.II(n) reporting. The Plan
currently states that market and marketable limit orders shall include
a ``yes/no'' field relating to the Retail Investor Order flag. The
Exchange is proposing Supplementary Material .02 to clarify that, for
purposes of the reporting requirement in Appendix B.II(n), a Trading
Center shall report ``y'' to their DEA where it is relying upon the
Retail Investor Order exception to Test Groups Two and Three, and ``n''
for all other instances.\30\ The Exchange believes that requiring the
identification of a Retail Investor Orders only where the exception may
apply (i.e., Pilot Securities in Test Groups Two and Three) is
consistent with Appendix B.II(n).
---------------------------------------------------------------------------

    \29\ The Exchange is also proposing Supplementary Material .01
to Rule 11.340 to clarify that certain enumerated terms used
throughout Rule 11.340 shall have the same meaning as set forth in
the Plan.
    \30\ FINRA, on behalf of the Plan Participants at the time
submitted a letter to the Commission requesting exemption from
certain provisions of the Plan related to data collection. See
letter from Marcia E. Asquith, Senior Vice President and Corporate
Secretary, FINRA dated December 9, 2015 to Robert W. Errett, Deputy
Secretary, Commission (``Exemption Request''). The Commission,
pursuant to its authority under Rule 608(e) of Regulation NMS,
granted BZX, as of February 10, 2016, a limited exemption from the
requirement to comply with certain provisions of the Plan as
specified in the letter and noted herein. See e.g., letter from
David Shillman, Associate Director, Division of Trading and Markets,
Commission to Eric Swanson, General Counsel, BZX, dated February 10,
2016 (``Exemption Letter''). On April 4, 2016, the Commission
granted the National Stock Exchange, Inc. (``NSX''), which was not a
Plan Participant as of February 10, 2016, comparative limited
exemption from such requirements. See, letter from John C. Roeser,
Associate Director, Division of Trading and Markets, Commission to
James Buckley, Chief Regulatory Officer, NSX, dated April 4, 2016.
IEX was not a Plan Participant at the time that such exemptions were
requested or granted and respectfully requests that the Commission
grant to it the same exemptions that the Commission granted to the
other Plan Participants.
---------------------------------------------------------------------------

    Supplementary Material .03 requires that Members populate a field
to identify to their DEA whether an order is affected by the bands in
place pursuant to the National Market System Plan to Address
Extraordinary Market Volatility.\31\ Pursuant to the Limit-Up Limit-
Down Plan, between 9:30 a.m. and 4:00 p.m., the Securities Information
Processor (``SIP'') calculates a lower price band and an upper price
band for each NMS stock. These price bands represent a specified
percentage above or below the stock's reference price, which generally
is calculated based on reported transactions in that stock over the
preceding five minutes. When one side of the market for an individual
security is outside the applicable price band, the SIP identifies that
quotation as non-executable. When the other side of the market reaches
the applicable price band (e.g., the offer reaches the lower price
band), the security enters a Limit State. The stock would exit a Limit
State if, within 15 seconds of entering the Limit State, all Limit
State Quotations were executed or canceled in their entirety. If the
security does not exit a Limit State within 15 seconds, then the
primary listing exchange declares a five-minute trading pause, which
would be applicable to all markets trading the security.
---------------------------------------------------------------------------

    \31\ See National Market System Plan to Address Extraordinary
Market Volatility, Securities Exchange Act Release No. 67091 (May
31, 2012), 77 FR 33498 (June 6, 2012) (File No. 4-631) (``Limit-Up
Limit-Down Plan'').
---------------------------------------------------------------------------

    The Exchange and the other Participants have determined that it is
appropriate to create a new flag for reporting orders that are affected
by the Limit-Up Limit-Down bands. Accordingly, a Trading Center shall
report a value of ``Y'' to their DEA when the ability of an order to
execute has been affected by the Limit-Up Limit-Down bands in effect at
the time of order receipt. A Trading Center shall report a value of
``N'' to their DEA when the ability of an order to execute has not been
affected by the Limit-Up Limit-Down bands in effect at the time of
order receipt.
    Supplementary Material .03 also requires, for securities that may
trade in a foreign market, that the Participant indicate whether the
order was handled domestically, or routed to a foreign venue.
Accordingly, the Participant will indicate, for purposes of Appendix
B.I, whether the order was: (1) Fully executed domestically, or (2)
fully or partially executed on a foreign market. For purposes of
Appendix B.II, the Participant will classify all orders in dually-
listed Pilot and Pre-Pilot Securities as: (1) Directed to a domestic
venue for execution; (2) may only be directed to a foreign venue for
execution; or (3) was fully or partially directed to a foreign venue at
the discretion of the Member. The Exchange believes that this proposed
flag will better identify orders in securities that may trade in a
foreign market, as such orders that were routed to foreign venues would
not be subject to the Plan's quoting and trading requirements, and
could otherwise compromise the integrity of the data.
    Supplementary Material .04 relates to the time ranges specified in
Appendix B.I.a(14), B.I.a(15), B.I.a(21) and B.I.a(22).\32\ The
Exchange and the other Participants have determined that it is
appropriate to change the reporting times in these provisions to
require more granular reporting for these categories. Accordingly, the
Exchange proposes to add Appendix B.I.a(14A), which will require
Trading Centers to report the cumulative number of shares of orders
executed from 100 microseconds to less than 1 millisecond after the
time of order receipt. Appendix B.I.a(15) will be changed to require
the cumulative number of shares of orders executed from 1 millisecond
to less than 100 milliseconds after the time of order receipt. The
Exchange also proposes to add Appendix B.I.a(21A), which will require
Trading Centers to report the cumulative number of shares of orders
canceled from 100 microseconds to less than 1 millisecond after the
time of order receipt. Appendix B.I.a(22) will be changed to require
the cumulative number of shares of orders canceled from 1 millisecond
to less than 100 milliseconds after the time of order receipt. The
Exchange believes that these new reporting requirements will contribute
to a meaningful analysis of the Pilot by producing more granular data
on these points.\33\
---------------------------------------------------------------------------

    \32\ Specifically, Appendix B.I.a(14) requires reporting of the
cumulative number of shares of orders executed from 0 to less than
100 microseconds after the time of order receipt; Appendix B.I.a(15)
requires reporting of the cumulative number of shares of orders
executed from 100 microseconds to less than 100 milliseconds after
the time of order receipt; Appendix B.I.a(21) requires reporting of
the cumulative number of shares of orders cancelled from 0 to less
than 100 microseconds after the time of order receipt; and appendix
B.I.a(22) requires reporting of the cumulative number of shares of
orders cancelled from 100 microseconds to less than 100 milliseconds
after the time of order receipt.
    \33\ On February 10, 2016, the Commission granted BZX an
exemption from Rule 608(c) related to this provision. See Exemption
Letter, supra, note 30. IEX requests that the Commission grant to it
this same exemption.
---------------------------------------------------------------------------

    Supplementary Material .05 relates to the relevant measurement for
purposes of Appendix B.I.a(31)-(33) reporting. Currently, the Plan
states that this data shall be reported as of the time of order
execution. The Exchange and the other Participants believe that this
information should more properly be captured at the time of order
receipt as

evaluating share-weighted average prices at the time of order receipt
is more consistent with the goal of observing the effect of the Pilot
on the liquidity of Pilot Securities. The Exchange is therefore
proposing to make this change through Supplementary Material .05.\34\
This change will make these provisions consistent with the remainder of
the statistics in Appendix B.I.a, which are all based on order receipt.
---------------------------------------------------------------------------

    \34\ On February 10, 2016, the Commission granted BZX an
exemption from Rule 608(c) related to this provision. See Exemption
Letter, supra, note 30. IEX requests that the Commission grant to it
this same exemption.
---------------------------------------------------------------------------

    Supplementary Material .06 addresses the status of not-held and
auction orders for purposes of Appendix B.I reporting. Currently,
Appendix B.I sets forth eight categories of orders, including market
orders, marketable limit orders, and inside-thequote resting limit
orders, for which daily market quality statistics must be reported.
Currently, Appendix B.I does not provide a category for not held
orders, clean cross orders, auction orders, or orders received when the
NBBO is crossed. The Exchange and the other Participants have
determined that it is appropriate to include separate categories for
both not held orders and auction orders for purposes of Appendix B
reporting. The Exchange is therefore proposing Supplementary Material
.06 to provide that not held orders shall be included as an order type
for purposes of Appendix B reporting, and shall be assigned the number
(18). Clean cross orders shall be included as an order type for
purposes of Appendix B reporting, and shall be assigned the number
(19); auction orders shall be included an as order type for purposes of
Appendix B reporting, and shall be assigned the number (20); \35\ and
orders that cannot otherwise be classified, including, for example,
orders received when the NBBO is crossed shall be included as an order
type for purposes of Appendix B reporting, and shall be assigned the
number (21). All of these orders already are included in the scope of
Appendix B; however, without this proposed change, these order types
would be categorized with other orders, such as regular held orders,
that should be able to be fully executed upon receipt, which would
compromise the value of this data.
---------------------------------------------------------------------------

    \35\ The Exchange notes that, as of the date of this filing, it
does not offer order types specifically defined as ``not held,''
``clean cross,'' or ``auction order.''
---------------------------------------------------------------------------

    The Exchange is proposing Supplementary Material .07 to clarify the
scope of the Plan as it relates to Members that only execute orders
limited purposes. Specifically, The Exchange and the other Participants
believe that a Member that only executes orders otherwise than on a
national securities exchange for the purpose of: (1) Correcting a bona
fide error related to the execution of a customer order; (2) purchasing
a security from a customer at a nominal price solely for purposes of
liquidating the customer's position; or (3) completing the fractional
share portion of an order \36\ shall not be deemed a Trading Center for
purposes of Appendix B to the Plan. The Exchange is therefore proposing
Supplementary Material .09 to make this clarification.
---------------------------------------------------------------------------

    \36\ The Exchange notes that where a Member purchases a
fractional share from a customer, the Trading Center that executes
the remaining whole shares of that customer order would be subject
to Appendix B of the Plan.
---------------------------------------------------------------------------

    The Exchange is proposing Supplementary Material .08 to clarify
that, for purposes of the Plan, Trading Centers must begin the data
collection required pursuant to Appendix B.I.a(1) through B.II.(y) of
the Plan and Item I of Appendix C of the Plan on April 4, 2016. While
the Exchange or the Member's DEA will provide the information required
by Appendix B and C of the Plan during the Pilot Period, the
requirement that the Exchange or their DEA provide information to the
SEC within 30 days following month end and make such data publicly
available on its Web site pursuant to Appendix B and C shall commence
six months prior to the beginning of the Pilot Period.\37\
---------------------------------------------------------------------------

    \37\ In the Approval Order, the SEC noted that the Pilot shall
be implemented within one year of the date of publication, i.e., by
May 6, 2016. See Approval Order, 80 FR at 27545. The SEC
subsequently extended the implementation date approximately five
months to October 3, 2016. See supra, note 9. See also Letter dated
November 4, 2015 from Brendon J. Weiss, Co-Head, Government Affairs,
Intercontinental Exchange/NYSE, to Brent J. Fields, Secretary,
Commission (requesting the data collection period be extended until
six months after the requisite SRO rules are approved, and the
implementation date of the Tick Size Pilot until six months
thereafter).
---------------------------------------------------------------------------

    The Exchange is proposing Supplementary Material .09 to address the
requirement in Appendix C.I(b) of the Plan that the calculation of raw
Market Maker realized trading profits utilize a last in, first out
(``LIFO'')-like method to determine which share prices shall be used in
that calculation. The Exchange and the other Participants believe that
it is more appropriate to utilize a methodology that yields LIFO-like
results, rather than utilizing a LIFO-like method, and the Exchange is
therefore proposing Supplementary Material .09 to make this change.\38\
The Exchange is proposing that, for purposes of Item I of Appendix C,
the Participants shall calculate daily Market Maker realized
profitability statistics for each trading day on a daily LIFO basis
using reported trade price and shall include only trades executed on
the subject trading day. The daily LIFO calculation shall not include
any positions carried over from previous trading days. For purposes of
Item I.c of Appendix C, the Participants shall calculate daily Market
Maker unrealized profitability statistics for each trading day on an
average price basis. Specifically, the Participants must calculate the
volume weighted average price of the excess (deficit) of buy volume
over sell volume for the current trading day using reported trade
price. The gain (loss) of the excess (deficit) of buy volume over sell
volume shall be determined by using the volume weighted average price
compared to the closing price of the security as reported by the
primary listing exchange. In reporting unrealized trading profits, the
Participant shall also report the number of excess (deficit) shares
held by the Market Maker, the volume weighted average price of that
excess (deficit) and the closing price of the security as reported by
the primary listing exchange used in reporting unrealized profit.\39\
---------------------------------------------------------------------------

    \38\ Appendix C.I currently requires Market Maker profitability
statistics to include (1) the total number of shares of orders
executed by the Market Maker; (2) raw Market Maker realized trading
profits, which is the difference between the market value of Market
Maker shares and the market value of Market Maker purchases, using a
LIFO-like method; and (3) raw Market Maker unrealized trading
profits, which is the difference between the purchase or sale price
of the end-of-day inventory position of the Market Maker and the
Closing Price. In the case of a short position, the Closing Price
from the sale will be subtracted; in the case of a long position,
the purchase price will be subtracted from the Closing Price.
    \39\ The Commission granted BZX, as of February 10, 2016, an
exemption from Rule 608(c) related to this provision. See Exemption
Letter, supra, note 30. IEX requests that the Commission grant to it
this same exemption.
---------------------------------------------------------------------------

    Finally, the Exchange is proposing Supplementary Material .10 to
address the securities that will be used for data collection purposes
prior to the commencement of the Pilot. The Exchange and the other
Participants have determined that it is appropriate to collect data for
a group of securities that is larger, and using different quantitative
thresholds, than the group of securities that will be Pilot Securities.
The Exchange is therefore proposing Supplementary Material .09 to
define ``Pre-Pilot Data Collection Securities'' as the securities
designated by the Participants for purposes of the data collection
requirements described in Items I, II and IV of Appendix B and Item I
of Appendix C of the Plan for the period beginning six months prior to
the

Pilot Period and ending on the trading day immediately preceding the
Pilot Period. The Participants shall compile the list of Pre-Pilot Data
Collection Securities by selecting all NMS stocks with a market
capitalization of $5 billion or less, a Consolidated Average Daily
Volume (CADV) of 2 million shares or less and a closing price of $1 per
share or more. The market capitalization and the closing price
thresholds shall be applied to the last day of the Pre-Pilot
measurement period, and the CADV threshold shall be applied to the
duration of the Pre-Pilot measurement period. The Pre-Pilot measurement
period shall be the three calendar months ending on the day when the
Pre-Pilot Data Collection Securities are selected. The Pre-Pilot Data
Collection Securities shall be selected thirty days prior to the
commencement of the six-month Pre-Pilot Period. On the trading day that
is the first trading day of the Pilot Period through six months after
the end of the Pilot Period, the data collection requirements will
become applicable to the Pilot Securities only. A Pilot Security will
only be eligible to be included in a Test Group if it was a PrePilot
Security.
Implementation Date
    The proposed rule change will be effective to coincide with IEX's
launch of exchange operations during a security-by-security phase-in
period.
2. Statutory Basis
    IEX believes that the proposed rule change is consistent with the
provisions of section 6 of the Act,\40\ in general and furthers the
objectives of sections 6(b)(5) of the Act \41\ in particular, in that
it is designed to promote just and equitable principles of trade, to
foster cooperation and coordination with persons engaged in
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.
---------------------------------------------------------------------------

    \40\ 15 U.S.C. 78f(b).
    \41\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    The Exchange believes that this proposal is consistent with the Act
because it implements and clarifies the provisions of the Plan, and is
designed to assist the Exchange in meeting its regulatory obligations
pursuant to the Plan. In approving the Plan, the SEC noted that the
Pilot was an appropriate, data-driven test that was designed to
evaluate the impact of wider tick size on trading, liquidity, and the
market quality of securities of smaller capitalization companies, and
was therefore in furtherance of the purposes of the Act. The Exchange
believes that this proposal is in furtherance of the objectives of the
Plan, as identified by the SEC, and is therefore consistent with the
Act because the proposal implements and clarifies the requirements of
the Plan and applies specific obligations to Members in furtherance of
compliance with the Plan.

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

    IEX does not believe that the proposed rule change will result in
any burden on competition that is not necessary or appropriate in
furtherance of the purposes of the Act. The Exchange notes that the
proposed rule change implements the provisions of the Plan, and is
designed to assist the Exchange in meeting its regulatory obligations
pursuant to the Plan. The Exchange also notes that the data collection
requirements for Members that operate Trading Centers will apply
equally to all such Members, as will the data collection requirements
for Market Makers.

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

    Written comments were neither solicited nor received.

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

    Because the proposed rule change does not (i) significantly affect
the protection of investors or the public interest; (ii) impose any
significant burden on competition; and (iii) become operative for 30
days from the date on which it was filed, or such shorter time as the
Commission may designate, it has become effective pursuant to section
19(b)(3)(A) of the Act \42\ and Rule 19b-4(f)(6) thereunder.\43\
---------------------------------------------------------------------------

    \42\ 15 U.S.C. 78s(b)(3)(A).
    \43\ 17 CFR 240.19b-4(f)(6). As required under Rule 19b-
4(f)(6)(iii), the Exchange provided the Commission with written
notice of its intent to file the proposed rule change, along with a
brief description and the text of the proposed rule change, at least
five business days prior to the date of filing of the proposed rule
change, or such shorter time as designated by the Commission.
---------------------------------------------------------------------------

    A proposed rule change filed pursuant to Rule 19b-4(f)(6) under the
Act \44\ normally does not become operative for 30 days after the date
of its filing. However, Rule 19b-4(f)(6)(iii) \45\ 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. The
Commission believes that waiver of the operative delay is consistent
with the protection of investors and the public interest because it
would allow the Exchange to implement the proposed rule change to
coincide with IEX's intent to launch exchange operations during a
security-by-security phase-in period scheduled to begin on August 19,
2016. Therefore, the Commission hereby waives the operative delay and
designates the proposal operative upon filing.\46\
---------------------------------------------------------------------------

    \44\ 17 CFR 240.19b-4(f)(6).
    \45\ 17 CFR 240.19b-4(f)(6)(iii).
    \46\ For purposes only of waiving the 30-day operative delay,
the Commission has also considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
---------------------------------------------------------------------------

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

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-IEX-2016-07 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-IEX-2016-07. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the

submission, all subsequent amendments, all written statements with
respect to the proposed rule change that are filed with the Commission,
and all written communications relating to the proposed rule change
between the Commission and any person, other than those that may be
withheld from the public in accordance with the provisions of 5 U.S.C.
552, will be available for Web site viewing and printing in the
Commission's Public Reference Room, 100 F Street NE., Washington, DC
20549, on official business days between the hours of 10:00 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; the Commission does not edit
personal identifying information from submissions. You should submit
only information that you wish to make available publicly. All
submissions should refer to File Number SR-IEX-2016-07, and should be
submitted on or before August 31, 2016.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\47\
---------------------------------------------------------------------------

    \47\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Robert W. Errett,
Deputy Secretary.
[FR Doc. 2016-18912 Filed 8-9-16; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 83, Number 238 (Wednesday, December 12, 2018)]
[Notices]
[Pages 63922-63924]
[FR Doc No: 2018-26836]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-84741; File No. SR-ISE-2018-97]

Self-Regulatory Organizations; Nasdaq ISE, LLC; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change To Amend
Supplementary Material .02 to Rule 715 Regarding Cancel and Replace
Orders

December 6, 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 November 29, 2018 Nasdaq ISE, LLC (``ISE'' or ``Exchange'') filed
with the Securities and Exchange Commission (``SEC'' or ``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

    The Exchange proposes to amend Supplementary Material .02 to Rule
715 regarding Cancel and Replace Orders.
    The text of the proposed rule change is available on the Exchange's
website at http://ise.cchwallstreet.com/, at the principal office of
the Exchange, and at the Commission's Public Reference Room.

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

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

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

1. Purpose
    The Exchange proposes to amend Supplementary Material .02 to Rule
715 regarding Cancel and Replace Orders to: (i) Correct an
inconsistency between the Exchange's rule text and the operation of the
System \3\ by removing the reference to Rule 710, (ii) update rule
cross-references, and (iii) make other non-substantive, technical
changes.
---------------------------------------------------------------------------

    \3\ The term ``System'' means the electronic system operated by
the Exchange that receives and disseminates quotes, executes orders
and reports transactions. See Rule 100(a)(63).
---------------------------------------------------------------------------

    Today, a member has the option of either sending in a cancel order
and then separately sending in a new order which serves as a
replacement of the original order (two separate messages), or sending a
single cancel and replace order in one message (i.e., a Cancel and
Replace Order). Specifically, Supplementary Material .02 to Rule 715
defines a Cancel and Replace Order as a single message for the
immediate cancellation of a previously received order and the
replacement of that order with a new order.\4\ The replacement portion
of the Cancel and Replace Order is treated as a new order and therefore
goes through price or other reasonability checks as a result of being
viewed as such.\5\ If the replacement portion of a Cancel and Replace
Order does not satisfy the System's price or other reasonability
checks, the existing order will be cancelled and not replaced.\6\ The
Exchange notes, however, that when it initially codified Cancel and
Replace Orders in its Rulebook as part of SR-ISE-2017-03, it
inadvertently included Rule 710 within the list of price reasonability
checks. In SR-ISE-2017-03, the Exchange explained that the System
conducts price or other reasonability checks for Cancel and Replace
Orders to validate such orders against the current market conditions
prior to proceeding with the request to modify the order.\7\ Rule 710,
which relates to the minimum price variations applicable to options
series traded on the Exchange, does not involve the System considering
the current market at the time of the Cancel and Replace Order, and an
incoming Cancel and Replace Order that fails the minimum price
variation checks in Rule 710 would not result in the existing order
being cancelled and not replaced.\8\ The Exchange therefore proposes to
remove the reference to Rule 710 from the list of price or other
reasonability checks to conform its rule text to the System.
---------------------------------------------------------------------------

    \4\ If the previously placed order is already filled partially
or in its entirety, the replacement order is automatically cancelled
or reduced by the number of contracts that were executed. See
Supplementary Material .02 to Rule 715.
    \5\ Supplementary Material .02 to Rule 715 further provides how
the replacement portion may retain the priority of the original
order, provided certain specified conditions are met. The manner in
which the Exchange treats priority with respect to Cancel and
Replace Orders is not changing under this proposal.
    \6\ See Securities Exchange Act Release No. 80432 (April 11,
2017), 82 FR 18191 (April 17, 2017) (SR-ISE-2017-03) (memorializing
Cancel and Replace Orders in Supplementary Material .02 to Rule 715
as part of the Exchange's system migration to INET technology).
    \7\ Id.
    \8\ In this instance, the System would simply reject the cancel
and replace message as an invalid instruction. The Exchange notes
that the previous T7 system likewise treated Cancel and Replace
Orders in this manner.
---------------------------------------------------------------------------

    The Exchange also proposes to update the various rule references
related to the price reasonability checks within this provision to
refer to the current rules.\9\ Finally, the Exchange proposes other
non-substantive, technical changes within Supplementary Material .02 to
Rule 715 to capitalize ``Cancel and Replace Order'' for consistency,
and to capitalize ``System,'' which is a defined term.
---------------------------------------------------------------------------

    \9\ In particular, Rules 711(c) and 714(b)(2) are now Rules
714(b)(1)(B) and 714(b)(1)(A), respectively, pursuant to SR-ISE-
2018-80. See Securities Exchange Act Release No. 84237 (September
20, 2018), 83 FR 48660 (September 26, 2018). Rule 722(b)(1) is now
Rule 722(c)(1) pursuant to SR-ISE-2018-56. See Securities Exchange
Act Release No. 84373 (October 5, 2018), 83 FR 51730 (October 12,
2018). Finally, paragraphs (b), (c), and (d) of Supplementary
Material .07 to Rule 722 are now paragraphs (a)(1)(A), (b), and
(c)(1), respectively, pursuant to SR-ISE-2018-55. See Securities
Exchange Act Release No. 83464 (June 19, 2018), 83 FR 29583 (June
25, 2018).
---------------------------------------------------------------------------

2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act,\10\ in general, and furthers the objectives of Section
6(b)(5) of the Act,\11\ 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. The Exchange's proposal corrects an inadvertent error in
Supplementary Material .02 to Rule 715, which currently includes Rule
710 within the list of price or other reasonability checks. As
discussed above, including Rule 710 is inconsistent with the operation
of the Exchange's System because an incoming Cancel and Replace Order
which fails the minimum price variation checks in Rule 710 does not
result in the existing order getting cancelled and not replaced. This
rule change would amend the rule text to reflect ISE's current
practice, and should avoid potential confusion about how the System
processes Cancel and Replace Orders today.\12\ Furthermore, the
Exchange's proposal to update the rule references and make other non-
substantive technical changes, as further described above, will bring
greater transparency to its Rulebook thereby protecting investors and
the public interest by reducing potential for investor confusion.
---------------------------------------------------------------------------

    \10\ 15 U.S.C. 78f(b).
    \11\ 15 U.S.C. 78f(b)(5).
    \12\ See note 8 above.
---------------------------------------------------------------------------

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. All of the proposed changes are intended to
bring greater transparency to the Exchange's Rulebook, and therefore
does not unduly burden competition.

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 \13\ and
subparagraph (f)(6) of Rule 19b-4 thereunder.\14\
---------------------------------------------------------------------------

    \13\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \14\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)
requires a self-regulatory organization to give the Commission
written notice of its intent to file the proposed rule change at
least five business days prior to the date of filing of the proposed
rule change, or such shorter time as designated by the Commission.
The Exchange has satisfied this requirement.
---------------------------------------------------------------------------

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

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-ISE-2018-97 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-ISE-2018-97. 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-2018-97 and should be submitted on
or before January 2, 2019.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\15\
---------------------------------------------------------------------------

    \15\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2018-26836 Filed 12-11-18; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 77, Number 222 (Friday, November 16, 2012)]
[Notices]
[Pages 68766-68767]
[FR Doc No: 2012-27965]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER13-342-000]

CPV Shore, LLC; Supplemental Notice That Initial Market-Based
Rate Filing Includes Request for Blanket Section 204 Authorization

    This is a supplemental notice in the above-referenced proceeding,
of CPV Shore, LLC's application for market-

based rate authority, with an accompanying rate schedule, 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 November 29, 2012.
    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 Street NE., Washington, DC 20426.
    The filings in the above-referenced proceeding(s) 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 email notification
when a document is added to a subscribed docket(s). For assistance with
any FERC Online service, please email<EMAIL_ADDRESS>or
call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.

    Dated: November 9, 2012.
Kimberly D. Bose,
Secretary.
[FR Doc. 2012-27965 Filed 11-15-12; 8:45 am]
BILLING CODE 6717-01-P