[Federal Register Volume 79, Number 103 (Thursday, May 29, 2014)]
[Notices]
[Pages 30911-30912]
[FR Doc No: 2014-12426]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-72230; File No. SR-CBOE-2014-029]

Self-Regulatory Organizations; Chicago Board Options Exchange,
Incorporated; Order Approving a Proposed Rule Change To Enhance the
Exchange's Audit Trail

May 22, 2014.

I. Introduction

    On March 27, 2014, the Chicago Board Options Exchange, Incorporated
(the ``Exchange'' or ``CBOE'') filed with the Securities and Exchange
Commission (the ``Commission''), pursuant to Section 19(b)(1) of the
Securities Exchange Act of 1934 (the ``Act'') \1\ and Rule 19b-4
thereunder,\2\ a proposed rule change to enhance the Exchange's audit
trail. The proposed rule change was published for comment in the
Federal Register on April 9, 2014.\3\ The Commission received no
comment letters regarding the proposed rule change. This order approves
the proposed rule change.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 71859 (April 3,
2014), 79 FR 19697 (``Notice'').
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II. Description of the Proposal

    The Exchange proposes to require Floor Brokers \4\ and PAR
Officials \5\ to electronically capture, by pressing a ``Represent
Button'' on their trading device, the time at which they initially
verbally present orders in the Exchange's trading crowd.\6\ The
Represent Button will be located on PAR workstations and other
Exchange-approved devices used by Floor Brokers.\7\
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    \4\ See CBOE Rule 6.70 defining a Floor Broker.
    \5\ See CBOE Rule 7.12(a) defining a PAR Official.
    \6\ See Notice, supra note 3, at 19697.
    \7\ See id.
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    According to the Exchange, CBOE Trading Permit Holders may use
Exchange-approved devices to systematize \8\ orders on the floor, but
the Exchange does not currently require Floor Brokers and PAR Officials
to electronically capture the time when orders are represented in the
trading crowd on these devices.\9\ The Exchange states that the
procedure Floor Brokers and PAR Officials currently follow to represent
orders and consummate trades on the Exchange's trading floor will not
change aside from the added step of capturing the time an order is
initially represented in the trading crowd by pushing the Represent
Button.\10\ The Exchange also represents that any new floor based order
management device will be required to have the Represent Button
functionality before CBOE will approve it to be used on the Exchange
trading floor if it will be used to represent orders on an agency
basis.\11\ The Exchange believes that capturing the time when orders
are represented on the Exchange's trading floor will help the Exchange
develop and implement surveillances concerning the Exchange's rules,
including, but not limited to, due diligence requirements of Floor
Brokers and Exchange priority rules.\12\
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    \8\ See id. at n. 4 (citing CBOE Rule 6.24).
    \9\ See id. at 19698.
    \10\ See id.
    \11\ See id. at n. 5.
    \12\ See id. at 19698.
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    The Exchange proposes to announce the implementation date of the
proposed rule change within 30 days following approval by the
Commission and has represented to the Commission that all devices
currently used to represent orders in the trading crowd by Floor
Brokers and PAR Officials will have the Represent Button functionality
by the time of implementation.\13\
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    \13\ See id.
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III. Discussion and Commission Findings

    After careful review, the Commission finds that the proposed rule
change is consistent with the requirements of the Act and the rules and
regulations thereunder applicable to a national securities
exchange.\14\ In particular, the Commission finds that the proposed
rule change is consistent with Section 6(b)(5) of the Act,\15\ which
requires, among other things, that the rules of a national securities
exchange be designed to prevent fraudulent and manipulative acts and
practices, 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.
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    \14\ In approving this proposal, the Commission has considered
the proposed rule's impact on efficiency, competition, and capital
formation. See 15 U.S.C. 78c(f).
    \15\ 15 U.S.C. 78f(b)(5).
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    As described above, the Exchange proposes to require that Floor
Brokers and PAR Officials press the Represent Button to capture
electronically the time at which they initially represent an order to
the Exchange's trading crowd. The Commission notes that the Exchange
has represented that, aside from this additional requirement, open out-
cry trading will generally continue to operate as it currently does
once this proposed rule change is implemented.\16\ The Represent Button
will be added to devices already used by Floor Brokers and PAR
Officials on the Exchange floor and represents an additional discrete
functionality to capture the time that an order is represented. The
Exchange also represents that this new requirement will apply equally
to all participants that handle agency orders in the trading crowd.\17\
The Commission believes that the proposed rule change represents an
incremental enhancement to CBOE's audit trail and should help
facilitate CBOE's ability to monitor activity on its trading floor and
assess compliance with its rules.
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    \16\ See Notice, supra note 3, at 19698.
    \17\ See id.

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IV. Conclusion

    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\18\ that the proposed rule change (SR-CBOE-2014-029) is approved.
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    \18\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\19\
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    \19\ 17 CFR 200.30-3(a)(12).
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Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2014-12426 Filed 5-28-14; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: May 12, 2010 (Volume 75, Number 91)]
[Rules and Regulations]
[Page 26668-26673]
[DOCID:fr12my10-10]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2009-0184; FRL-8812-6]

Flutriafol; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of
flutriafol, [()-[alpha]-(2-fluorophenyl)-[alpha]-(4-
fluorophenyl)-1H-1,2,4-triazole-1-ethanol], including its metabolites
and degradates in or on apple at 0.20 ppm; soybean, seed at 0.35 ppm;
and grain, aspirated fractions at 2.2 ppm; and cattle, goat, hog, horse
and sheep liver at 0.02 ppm. Cheminova A/S, c/o Cheminova, Inc.
requested these tolerances under the Federal Food, Drug, and Cosmetic
Act (FFDCA).

DATES: This regulation is effective May 12, 2010. Objections and
requests for hearings must be received on or before July 12, 2010, 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-2009-0184. 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: Tamue L. Gibson, Registration Division
(7505P), Office of Pesticide Programs, 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 those
engaged in the following activities:
     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 to
provide 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 EPA's tolerance regulations
at 40 CFR part 180 through the Government Printing Office's e-CFR cite
at http://www.gpoaccess.gov/ecfr. To access the OPPTS Harmonized Test
Guidelines referenced in this document, go directly to the guidelines
at http://www.epa.gov/opptsfrs/home/guidelin.htm.

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. 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-2009-0184 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 as required by 40 CFR part 178
on or before July 12, 2010.
    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 this copy, identified by docket ID number
EPA-HQ-OPP-2009-0184, 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. Petition for Tolerance

    In the Federal Register of April 8, 2009 (74 FR 15973) (FRL-8407-
4), 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 petition (PP
7F7197) by Cheminova A/S, c/o Cheminova, Inc., 1600 Wilson Blvd.,
Arlington, VA 22209. The petition requested that 40 CFR 180 be amended
by establishing tolerances for residues of the fungicide flutriafol in
or on the following raw agricultural commodities: Apple at 0.2 parts
per million (ppm); apple, wet pomace at 0.3 ppm; soybean at 0.3 ppm;
soybean, aspirated grain fractions at 0.5 ppm; and liver (cattle, goat,
hog, horse and sheep) at 0.01 ppm. That notice referenced a summary of
the petition prepared by Cheminova A/S, c/o Cheminova Inc., the
registrant, which is available to the public in the docket, http://
www.regulations.gov. There were no comments received in response to the
notice of filing.
    Based upon review of the data supporting the petition, EPA has
determined that tolerances are not needed for apple, juice; wet apple
pomace; soybean meal; soybean hull; and soybean oil. Additionally,
tolerances were increased for soybean seed; aspirated grain fractions;
and cattle, goat, hog, horse and sheep liver. The reason for these
changes are explained in Unit IV.D.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(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.
Section 408(b)(2)(C) of FFDCA requires 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. . .
.''
    Consistent with section 408(b)(2)(D) of FFDCA, and the factors
specified in section 408(b)(2)(D) of FFDCA, EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has sufficient data to assess the hazards of and to
make a determination on aggregate exposure for the petitioned-for
tolerances for residues of flutriafol including its metabolites and
degradates in or on apple at 0.20 ppm; soybean, seed at 0.35 ppm;
grain, aspirated fractions at 2.2 ppm; and cattle, goat, hog, horse and
sheep liver at 0.02 ppm. EPA's assessment of exposures and risks
associated with establishing tolerances follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies 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. Specific information on the studies received and the nature
of the adverse effects caused by flutriafol as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at http://
www.regulations.gov in document Flutriafol. Human-Health Risk
Assessment for Proposed Uses on Apple and Soybean at page 20 in docket
ID number EPA-HQ-OPP-2009-0184.
    Flutriafol has low acute oral and inhalation toxicity. A 28-day
dermal toxicity study did not reveal any signs of toxicity at the limit
dose (1,000 mg/kg/day). Thus, flutriafol is not considered to be
acutely toxic via the dermal route. Flutriafol is minimally irritating
to the eyes and is not a dermal irritant. Flutriafol was not shown to
be a skin sensitizer when tested in guinea pigs.
    The pattern of toxicity attributed to flutriafol exposure via the
oral route includes hepatotoxicity, developmental toxicity (manifested
as increased intrauterine death) at the same dose as parental toxicity,
and generalized toxicity (body weight/body weight gains and food
consumption decrements as well as slight anemia).
    Short-term, subchronic, and chronic toxicity studies in rats, mice,
and dogs identified the liver as the primary target organ of
flutriafol. Hepatotoxicity was first evident in the subchronic studies
(rats and dogs) in the form of increases in liver enzymes (alkaline
phosphatase), liver weights, and histopathology findings ranging from
hepatocyte vacuolation to centrilobular hypertrophy and slight
increases in hemosiderin-laden Kupffer cells. With chronic exposures,
there were no indications of progression of liver toxicity in either
species. Neither the chronic/carcinogenicity study in rats nor the
carcinogenicity study in mice revealed treatment-related increases in
tumor incidences.
    Slight indications of effects on red blood cells were sporadically
seen in the database. These effects were manifested in the form of
slight anemia and increased hemosiderin in the liver or spleen of rats
and dogs. Increased platelet, white blood cell, neutrophil, and
lymphocyte counts were also observed in one study in mice. However,
these effects were minimal in severity, were not considered adverse,
and were not observed in any other study or species.

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no
appreciable risk, a toxicological point of departure (POD) is
identified as the basis for derivation of reference values for risk
assessment. The POD may be defined as the highest dose at which no
adverse effects are observed (the NOAEL) in the toxicology study
identified as appropriate for use in risk assessment. However, if a
NOAEL cannot be determined, the lowest dose at which adverse effects of
concern are identified (the LOAEL) or a Benchmark Dose (BMD) approach
is sometimes used for risk assessment. Uncertainty/safety factors (UFs)
are used in conjunction with the POD to take into account uncertainties
inherent in the extrapolation from laboratory animal data to humans and
in the variations in

sensitivity among members of the human population as well as other
unknowns. Safety is assessed for acute and chronic dietary risks by
comparing aggregate food and water exposure to the pesticide to the
acute population adjusted dose (aPAD) and chronic population adjusted
dose (cPAD). The aPAD and cPAD are calculated by dividing the POD by
all applicable UFs. Aggregate short-, intermediate-, and chronic-term
risks are evaluated by comparing food, water, and residential exposure
to the POD to ensure that the margin of exposure (MOE) called for by
the product of all applicable UFs is not exceeded. This latter value is
referred to as the Level of Concern (LOC).
    For non-threshold risks, the Agency assumes that any amount of
exposure will lead to some degree of risk. Thus, the Agency estimates
risk in terms of the probability of an occurrence of the adverse effect
greater than that expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see http://www.epa.gov/
pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for flutriafol used for
human risk assessment can be found at http://www.regulations.gov in
document Flutriafol. Human-Health Risk Assessment for Proposed Uses on
Apple and Soybean at page 20 in docket ID number EPA-HQ-OPP-2009-0184.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to flutriafol, EPA considered exposure under the petitioned-
for tolerances for soybean and apples. Tolerances have been previously
established in 40 CFR 180.629 in or on soybean treated under section 18
of FIFRA. EPA assessed dietary exposures from flutriafol in food as
follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure.
    In conducting the acute dietary exposure assessment, EPA used the
Dietary Exposure Evaluation Model software with the Food Commodity
Intake Database (DEEM-FCID\TM\, version 2.03) which incorporates food
consumption data as reported by respondents in the United States
Department of Agriculture (USDA) 1994-1996 and 1998 Nationwide
Continuing Surveys of Food Intake by Individuals (CSFII). The following
assumptions were made for the acute exposure assessment: Tolerance-
level residues, 100% crop treated (CT), and DEEM\TM\ version 7.81
default processing factors were used.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment, EPA used the DEEM\TM\ software with DEEM-FCID\TM\, version
2.03 which incorporates food consumption data as reported by
respondents in the USDA 1994-1996 and 1998 Nationwide CSFII. The
following assumptions were made for the chronic exposure assessment:
Tolerance-level residues, 100% CT, and DEEM\TM\ version 7.81 default
processing factors were used.
    iii. Cancer. The Agency classified flutriafol as ``Not Likely to be
Carcinogenic to Humans'' based on the results of the carcinogenicity
studies in rats and mice. All genotoxicity studies on flutriafol showed
no evidence of clastogenicity or mutagenicity. Flutriafol is a member
of a class of pesticides known as triazoles. Although several triazoles
are carcinogenic, many are not and flutriafol has been adequately
tested and found not to be carcinogenic in long-term studies in rats
and mice. Structure-activity-relationship analysis indicates that
flutriafol may have the potential to produce thyroid and/or liver
tumors in rodents. However, in the rat and mouse carcinogenicity
studies, there were no treatment-related increases in tumor incidence
when comparing treated animals to controls.
    iv. Anticipated residue and percent crop treated (PCT) information.
EPA did not use anticipated residue and/or PCT information in the
dietary assessment for flutriafol. Tolerance level residues and 100% CT
were assumed for all food commodities.
    2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for flutriafol in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of flutriafol. Further information regarding EPA
drinking water models used in pesticide exposure assessment can be
found at http://www.epa.gov/oppefed1/models/water/index.htm.
    Based on the First Index Reservoir Screening Tool (FIRST), and
Screening Concentration in Ground Water (SCI-GROW) models, the
estimated drinking water concentrations (EDWCs) of flutriafol for acute
exposures are estimated to be 48.8 parts per billion (ppb) for surface
water and 4.8 ppb for ground water. For chronic exposures for non-
cancer assessments are estimated to be 5.7 ppb for surface water and
4.8 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For acute dietary risk
assessment, the water concentration value of 48.8 ppb was used to
assess the contribution to drinking water. For chronic dietary risk
assessment, the water concentration of value 5.7 ppb was used to assess
the contribution to drinking water.
    3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets).
    Flutriafol is not registered for any specific use patterns that
would result in residential exposure.
    4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, 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.''
    Flutriafol is a member of the triazole-containing class of
pesticides. Although conazoles act similarly in plants (fungi) by
inhibiting ergosterol biosynthesis, there is not necessarily a
relationship between their pesticidal activity and their mechanism
toxicity in mammals. Structural similarities do not constitute a common
mechanism of toxicity. Evidence is needed to establish that the
chemicals operate by the same, or essentially the same, sequence of
major biochemical events. In conazoles, however, a variable pattern of
toxicological responses is found; some are hepatotoxic and
hepatocarcinogenic in mice. Some induce thyroid tumors in rats. Some
induce developmental, reproductive, and neurological effects in
rodents. Furthermore, the conazoles produce a diverse range of
biochemical events including altered cholesterol levels, stress
responses, and altered DNA methylation. It is not clearly understood
whether these biochemical events are directly connected to their
toxicological outcomes. Thus, there is currently no evidence to
indicate that conazoles share common mechanisms of toxicity and EPA is
not following a cumulative risk approach based on a common mechanism of
toxicity for the conazoles. For information regarding EPA's procedures
for cumulating effects from substances found to have a

common mechanism of toxicity, see EPA's website at http://www.epa.gov/
pesticides/cumulative.
    Triazole-derived pesticides can form the metabolite 1,2,4-triazole
(T) and two triazole conjugates triazolylalanine (TA) and
triazolylacetic acid (TAA). To support existing tolerances and to
establish new tolerances for triazole-derivative pesticides, EPA
conducted an initial human-health risk assessment for exposure to T,
TA, and TAA resulting from the use of all current and pending uses of
any triazole-derived fungicide as of September 1, 2005. The risk
assessment was a highly conservative, screening-level evaluation in
terms of hazards associated with common metabolites (e.g., use of a
maximum combination of uncertainty factors) and potential dietary and
non-dietary exposures (i.e., high-end estimates of both dietary and
non-dietary exposures). In addition, the Agency retained the additional
10X FQPA SF for the protection of infants and children. The assessment
included evaluations of risks for various subgroups, including those
comprised of infants and children. The Agency's complete risk
assessment can be found in the propiconazole reregistration docket at
http://www.regulations.gov, Docket Identification (ID) Number EPA-HQ-
OPP-2005-0497.
    The Agency completed an updated dietary risk assessment considering
exposure to T, TA, and TAA based on established and proposed uses of
triazole fungicides; however, this risk assessment did not include
flutriafol uses. The resulting acute and chronic exposure to T, TA, and
TAA were less than the Agency's level of concern (T: <=36% aPAD and
<=54% cPAD; TA/TAA: 34% aPAD and <=40% cPAD). The Agency concludes that
revised T and TA/TAA dietary risk assessments are unnecessary for the
following reasons: (1) Incorporation of the flutriafol uses resulted in
negligible changes to the T and TA/TAA residue estimates incorporated
into the previous dietary analyses and (2) the T and TA/TAA drinking
water estimates incorporated into the previous dietary analyses assumed
an annual fungicide application rate of 10.38 pound active ingredient/
acre (lb ai/acre) for nonagricultural uses and 2.0 lb ai/acre for
agricultural uses and the formation of T and/or TA/TAA at 30.7% of the
applied rate. Since the annual application rate for flutriafol is
<=0.63 lb ai/acre and since all environmental degradates were
identified at <10% total radioactive residue (TRR), a revised drinking
water assessment was unnecessary.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) 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 on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA SF. In
applying this provision, EPA either retains the default value of 10X,
or uses a different additional safety factor when reliable data
available to EPA support the choice of a different factor.
    2. Prenatal and postnatal sensitivity. The potential impact of in
utero and perinatal flutriafol exposure was investigated in three
developmental toxicity studies (two in rats, one in rabbits) and a
multigeneration reproduction toxicity study in rats. Only one of the
rat developmental toxicity studies was acceptable. Qualitative
susceptibility was noted in the acceptable rat developmental study and
in the two-generation reproduction study.
    In the acceptable rat developmental study, developmental toxicity
(late resorptions, skeletal malformations and variations, decrease in
fetal weights) occurred at the same dose level that elicited maternal
toxicity (late resorptions, decreased food consumption, body weight
gains). In rabbits, a decreased number of live fetuses were observed at
the same dose that also caused adverse effects in maternal animals
(complete litter resorptions, increased post-implantation loss,
decreased body weight gain and food consumption).
    In the two-generation reproduction study, effects in the offspring
(decreased litter size and percentage of live births and liver
toxicity) were observed at the same dose as parental toxicity
(decreased body weight and food consumption and liver toxicity) and may
be related to the systemic toxicity of the parents. There is no concern
for the offspring toxicity observed in the developmental and
reproductive toxicity studies for the following reasons: (1) the
effects were seen in the presence of maternal/parental/systemic
toxicity; (2) clear NOAELs and LOAELs were established in the fetuses/
offspring; (3) the dose-response for these effects are well defined and
characterized; and (4) developmental endpoints are used for assessing
acute dietary risks to the most sensitive population (females 13-49) as
well as all other short- and intermediate-term exposure scenarios.
    3. Conclusion. EPA has determined that reliable data show that it
would be safe for infants and children to reduce the FQPA safety factor
to 1X. That decision is based on the following findings.
     Except for an immunotoxicity study, the toxicological
database is complete. In accordance with the revised part 158 an
immunotoxicity study is required. In the case of flutriafol, there was
no evidence of toxicity to the immune organs in any study in the
database. Increased hemosiderin in the spleen was observed in rats or
dogs. However, this was considered due to the storage of iron following
the clearance of damaged erythrocytes from the blood and not to an
immunotoxic effect. Increased platelet, white blood cell, neutrophil,
and lymphocyte counts were also observed in one study in mice. However,
these effects were minimal in severity, were not considered adverse,
and were not observed in any other study or species. Therefore, they
are not considered immunotoxic effects.
    In addition, flutriafol does not belong to a class of chemicals
(e.g., the organotins, heavy metals, or halogenated aromatic
hydrocarbons) that would be expected to be immunotoxic. Based on the
above considerations, the Agency does not believe that conducting a
special series OPPTS Harmonized Guideline 870.7800 immunotoxicity study
will result in a point of departure lower than that used for overall
risk assessment. Therefore an additional UFDB does not need to be
applied.
     There are no concerns or residual uncertainties for pre-
and/or post-natal toxicity. There is no evidence of quantitative
susceptibility following in utero exposures to rats or rabbits and
following pre- and post-natal exposures to rats for two generations.
There is no concern for the offspring toxicity observed in the
developmental and reproductive toxicity studies for the following
reasons: (1) The effects were seen in the presence of maternal/parental
systemic toxicity; (2) clear NOAELs and LOAELs were established in the
fetuses/offspring; (3) the dose-response for these effects are well
defined and characterized; and (4) developmental endpoints are used for
assessing acute dietary risks to the most sensitive population (females
13-49) as well as all other short- and intermediate-term exposure
scenarios.

     There is no concern for neurotoxicity with flutriafol.
Signs of neurotoxicity were reported in the acute and subchronic
neurotoxicity studies at the highest dose only; however, these effects
were primarily seen in animals that were agonal (at the point of death)
and, thus are not indicative of neurotoxicity. In addition, there was
no evidence of neurotoxicity in any additional short-term studies in
rats, mice, and dogs, or in the long-term toxicity studies in rats,
mice, and dogs.
     A developmental neurotoxicity study is not required.
     The dietary exposure assessment is conservative in nature
(utilized tolerance level residues and 100% CT were utilized).
     Conservative (protective) assumptions were used in the
ground water and surface water modeling to assess exposure to
flutriafol in drinking water.
     There are no proposed residential uses.
     Based on summaries of confined/field rotational crop
studies submitted by the petitioner, the Agency determined that
rotation of only soybean to a treated field was acceptable. The Agency
is requesting that the petitioner submit a detailed version of these
studies and views this requirement as confirmatory and, therefore, not
requiring the application of additional uncertainty factors.
     Storage stability data for flutriafol and/or its
metabolites in/on livestock and soybean commodities have been
requested. Based on the available storage stability data, which did not
result in the degradation of flutriafol or its metabolites in a variety
of matrices, the Agency views these data as confirmatory and,
therefore, not requiring the application of additional uncertainty
factors.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic pesticide exposures are
safe by comparing aggregate exposure estimates to the aPAD and cPAD.
The aPAD and cPAD represent the highest safe exposures, taking into
account all appropriate SFs. EPA calculates the aPAD and cPAD by
dividing the POD by all applicable UFs. For linear cancer risks, EPA
calculates the probability of additional cancer cases given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the POD to ensure that the MOE called for
by the product of all applicable UFs is not exceeded.
    1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food and water
to flutriafol will occupy 3.7% of the aPAD for (females 13-49 years
old) the population group receiving the greatest exposure.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
flutriafol from food will utilize 4.6% of the cPAD for (children 1 to 2
years old) the population group receiving the greatest exposure. There
are no proposed or existing residential uses of flutriafol. Therefore,
chronic dietary exposure to flutriafol is not a concern to the Agency.
    3. Short-term risk. Short-term aggregate exposure takes into
account short-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level).
    Flutriafol is not registered for any use patterns that would result
in residential exposure. Therefore, the short-term aggregate risk is
the sum of the risk from exposure to flutriafol through food and water
and will not be greater than the chronic aggregate risk.
    4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level).
    Flutriafol is not registered for any use patterns that would result
in intermediate-term residential exposure. Therefore, the intermediate-
term aggregate risk is the sum of the risk from exposure to flutriafol
through food and water, which has already been addressed, and will not
be greater than the chronic aggregate risk.
    5. Aggregate cancer risk for U.S. population. For flutriafol there
were no treatment-related increases in tumor incidence when comparing
treated animals to controls in the rat and mouse carcinogenicity
studies. Therefore, the human cancer risk from flutriafol is
negligible.
    6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to flutriafol residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodologies (multiresidue method (MRM)
Protocol D for apples; GC/Nitrogen/Phosphorus detector (NPD) method for
soybean seed and method ICIA AM00306 for ruminant liver) are available
to enforce the tolerance expression. The methods may be requested from:
Chief, Analytical Chemistry Branch, Environmental Science Center, 701
Mapes Rd., Ft. Meade, MD 20755-5350; telephone number:<PHONE_NUMBER>;
e-mail address<EMAIL_ADDRESS>
B. International Residue Limits

    There are no currently established Codex, Canadian, or Mexican
maximum residue limits for flutriafol on apples and soybeans.

C. Revisions to Petitioned-For Tolerances

    Based on the processing data, the Agency determined that apple
juice, wet apple pomace, soybean meal, soybean hull, and soybean oil
tolerances are unnecessary. However, a tolerance for grain, aspirated
fractions at 2.2 is required. Based on the crop field trial data,
livestock feeding study, and/or the tolerance calculator, EPA is
recommending for higher tolerances than that proposed by the petitioner
for soybean, seed; aspirated grain fractions, and liver (cattle, goat,
hog, horse, and sheep).

V. Conclusion

    Therefore, tolerances are established for residues of flutriafol
including its metabolites and degradates in or on apple at 0.20 ppm;
soybean, seed at 0.35 ppm; grain, aspirated fractions at 2.2 ppm;
cattle, goat, hog, horse and sheep liver at 0.02 ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances 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).

VII. 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: April 28, 2010.
Steven Bradbury,
Director, 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. Revise Sec.  180.629 to read as follows:

180.629  Flutriafol; tolerances for residues.

    (a) General. Tolerances are established for the residues of
flutriafol, [()-[alpha]-(2-fluorophenyl)-[alpha]-(4-
fluorophenyl)-1H-1,2,4-triazole-1-ethanol], including its metabolites
and degradates in or on the following commodities. Compliance with the
following tolerances is to be determined by measuring flutriafol only.

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
Apple................................................               0.20
Cattle, liver........................................               0.02
Goat, liver..........................................               0.02
Grain, aspirated fractions...........................                2.2
Hog, liver...........................................               0.02
Horse, liver.........................................               0.02
Sheep, liver.........................................               0.02
Soybean, seed........................................               0.35
------------------------------------------------------------------------

    (b) Section 18 tolerance [Reserved].
    (c) Tolerances with regional registrations [Reserved].
    (d) Indirect or inadvertent residues [Reserved].

[FR Doc. 2010-11296 Filed 5-11-10; 8:45 am]
BILLING CODE 6560-50-S


[Federal Register Volume 79, Number 30 (Thursday, February 13, 2014)]
[Notices]
[Page 8780]
[FR Doc No: 2014-03259]

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SECURITIES AND EXCHANGE COMMISSION

[File No. 500-1]

Centor Energy, Inc.; Order of Suspension of Trading

February 11, 2014.
    It appears to the Securities and Exchange Commission that there is
a lack of current and accurate information concerning the securities of
Centor Energy, Inc. (``Centor'') because of questions regarding the
accuracy of assertions by Centor, and by others, in press releases and
promotional materials concerning, among other things, the company's
assets, operations, and financial prospects. Centor is a Nevada company
based in Florida. The company's common stock is quoted on the OTC Link
under the symbol CNTO.
    The Commission is of the opinion that the public interest and the
protection of investors require a suspension of trading in the
securities of the above-listed company.
    Therefore, it is ordered, pursuant to Section 12(k) of the
Securities Exchange Act of 1934, that trading in the securities of the
above-listed company is suspended for the period from 9:30 a.m. EST on
February 11, 2014 through 11:59 p.m. EST on February 25, 2014.

    By the Commission.
Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2014-03259 Filed 2-11-14; 4:15 pm]
BILLING CODE 8011-01-P


NOTICE OF CHAUTAUQUA AIRLINES, INC.

D/B/A US AIRWAYS EXPRESS

Pursuant to Order 2001-9-20, Chautauqua Airlines, Inc., d/b/a US Airways
Express, gives the following notice of service reductions that have been
implemented since September 11, 2001:

Termination of the last Nonstop Service in a Domestic Market.

Chautauqua Airlines, Inc., d/b/a US Airways Express, terminated
scheduled airline service between Indianapolis, IN and Grand Rapids, MI
effective September 18, 2001.  Such service had been provided twice
daily using Saab 340 aircraft seating 30 passengers.

Chautauqua Airlines, Inc., d/b/a US Airways Express, terminated
scheduled airline service between Indianapolis, IN and Evansville, IN
effective September 18, 2001.  Such service had been provided three
times daily (with reduced frequency on weekends) using Saab 340 aircraft
seating 30 passengers.

Chautauqua Airlines, Inc., d/b/a US Airways Express, terminated
scheduled service between Indianapolis, IN and Columbus, OH effective
October 7, 2001.  Such service had been provided twice daily using Saab
340 aircraft seating 30 passengers.  One daily round trip was
discontinued on September 18, the other on October 7, 2001.

Reduction of Service at a U.S. Community if the total available flights
linking that community with FAA-designated hubs will be reduced by 33
percent or more.

Chautauqua Airlines, Inc., d/b/a US Airways Express, has reduced flight
frequency between Pittsburgh, PA and Altoona, PA effective October 7,
2001 by approximately 40 percent.  Two of five scheduled daily Saab 340
round trips between Pittsburgh and Altoona have been removed, one
effective September 18, the second effective October 7.  Three daily
Saab 340 round trips remain.

Respectfully submitted,

Jeffrey B. Jones

VP Planning

Chautauqua Airlines, Inc.

2500 S. High School Road, Suite 160

Indianapolis, IN 46241


[Federal Register Volume 80, Number 2 (Monday, January 5, 2015)]
[Notices]
[Pages 268-269]
[FR Doc No: 2014-30809]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-73950; File No. SR-NASDAQ-2014-100]

Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Order
Approving a Proposed Rule Change To Amend NASDAQ Rule 7015(d) To
Include the IPO Indicator as a New Enhancement to the NASDAQ
Workstation

December 29, 2014.

I. Introduction

    On October 29, 2014, The NASDAQ Stock Market LLC (``NASDAQ'' or the
``Exchange'') filed with the Securities and Exchange Commission
(``Commission''), pursuant to Section 19(b)(1) of the Securities
Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4 thereunder,\2\ a
proposed rule change to include a new feature, the IPO Indicator, that
is designed to assist Exchange member firms in monitoring their orders
during the NASDAQ Halt Cross process leading up to the launch of an
initial public offering (``IPO''). The proposed rule change was
published for comment in the Federal Register on November 18, 2014.\3\
The Commission received no comments on the proposal. This order
approves the proposed rule change.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 73574 (November 12,
2014), 79 FR 68745 (``Notice'').
---------------------------------------------------------------------------

II. Description of the Proposal

    The Exchange proposes to amend Exchange Rule 7015(d) to include the
IPO Indicator as a new enhancement to the NASDAQ Workstation. According
to the Exchange, the NASDAQ Workstation provides order entry and quote
functionality and includes several features to assist subscribers with
managing and monitoring their trading activity.\4\ The Exchange
proposes to include the IPO Indicator as a new feature that is designed
to assist member firms in monitoring their orders during the NASDAQ
Halt Cross process.\5\
---------------------------------------------------------------------------

    \4\ See id. at 68745.
    \5\ See id.
---------------------------------------------------------------------------

    According to the Exchange, the NASDAQ Halt Cross (``Cross'') is
designed to provide for an orderly, single-priced opening of securities
subject to an intraday halt, including securities that are the subject
of an IPO.\6\ Prior to the Cross execution, the Exchange states that
market participants enter quotes and orders eligible for participation
in the Cross, and the Exchange disseminates certain information
regarding buying and selling interest entered and the indicative
execution price information, known as the Net Order Imbalance Indicator
(``NOII'').\7\ The Exchange further states that the NOII is
disseminated every five seconds during a designated period prior to the
completion of the Halt Cross, in order to provide market participants
with information regarding the possible price and volume of the Cross.
According to the Exchange, the information provided in the NOII message
includes the Current Reference Price \8\ and the number of shares of
Eligible Interest.\9\
---------------------------------------------------------------------------

    \6\ See id.
    \7\ See id.
    \8\ See Exchange Rule 4753(a)(3)(A). The Exchange describes the
Current Reference Price as the price at which the Cross would occur
if it executed at the time of the NOII's dissemination. See Notice,
supra note 3, at 68745.
    \9\ See Exchange Rule 4753(a)(5) (defining Eligible Interest as
``any quotation or any order that has been entered into the system
and designated with a time-in-force that would allow the order to be
in force at the time of the Halt Cross'').
---------------------------------------------------------------------------

    The Exchange also disseminates information about the size and buy/
sell direction of an Imbalance,\10\ which the Exchange defines as the
number of shares of Eligible Interest with a limit price equal to the
Current Reference Price that may not be matched with other order shares
at a particular price at any given time.\11\ The Exchange states that
the disseminated information reflects all shares eligible for
participation in the Cross, regardless of time-in-force (including non-
displayed shares and reserve size) and is meant to indicate the degree
to which available liquidity on one or the other side of the market
would not be executed if the Cross were to occur at that time.
---------------------------------------------------------------------------

    \10\ See Exchange Rule 4753(a)(1).
    \11\ See Notice, supra note 3, at 68745. The Exchange states
that it also disseminates a Market Order Imbalance, which the
Exchange defines as the number of shares of Eligible Interest
entered through market orders that would not be matched with other
order shares at the time of the dissemination of a NOII, if in fact
there are such unexecutable market order shares. See Exchange Rule
4753(a)(2). When there is a Market Order Imbalance, the Exchange
notes that it disseminates the imbalance and the buy/sell direction
of the imbalance. See Notice, supra note 3, at 68745.
---------------------------------------------------------------------------

    In the case of an IPO, the Exchange states that the Halt Cross
operates as follows: First, the underwriters to the IPO make a
determination to launch the IPO during the Pre-Launch Period \12\ when
the underwriters believe the security is ready to trade.\13\ Second,

once the underwriter informs the Exchange that it is ready to launch
the IPO, the NASDAQ system calculates the Current Reference Price at
that time (the ``Expected Price'') and displays it to the
underwriter.\14\ If the underwriter then approves proceeding, the
NASDAQ system conducts two validation checks: (1) The NASDAQ system
determines whether all market orders will execute in the cross; and (2)
whether the Expected Price and the price calculated by the Cross differ
by an amount in excess of the price band selected by the
underwriter.\15\ According to the Exchange, if either of the validation
checks fails, the security will not be released for trading and the
Pre-Launch Period will continue until all requirements are met.\16\
---------------------------------------------------------------------------

    \12\ The Exchange explains that the Pre-Launch Period is the
second phase of a two-phase process that NASDAQ uses for launching
IPOs. See id. at 68746. According to the Exchange, the Pre-Launch
Period follows a 15-minute Display Only Period and is of no fixed
duration. See id. In addition, the Exchange states that the NOII is
disseminated every five seconds during both periods. See id.
    \13\ See id. at 68745.
    \14\ See id. at 68746.
    \15\ See Notice, supra note 3, at 68746.
    \16\ See id. Alternatively, the underwriter may, with the
concurrence of the Exchange, determine to postpone and reschedule
the IPO. See id.
---------------------------------------------------------------------------

    The Exchange proposes to offer the IPO Indicator to provide
information about the number and price at which shares of a member
firm's orders entered for execution in an IPO Halt Cross (``IPO
shares'') would execute in an IPO if it were to price at the present
time.\17\ Under the proposal, the IPO Indicator would be offered
through the NASDAQ Workstation and would use the NOII information
already currently available through a Workstation subscription together
with the information about the member firm's orders on NASDAQ.\18\
Under the proposal, the Exchange states that member firms using the IPO
Indicator would be able to see the Current Reference Price, the number
of paired shares, the number of imbalance shares, the total number of
IPO shares the member firm has entered for execution in the IPO Halt
Cross, the nature of such shares (buy or sell), and the number of IPO
shares that would be executed in the Halt Cross at that time for each
of those categories.\19\ In addition, the Exchange states that member
firms using the IPO Indicator would also be able to see details about
its IPO shares presented by individual orders or order blocks, which
would include the number of IPO shares in a particular order or order
block, the number and percentage of IPO shares of the order or order
block that would be executed in the Halt Cross if it occurred at any
given time in the process, based on the NOII disseminated every five
seconds, and the price at which the order or order block was
submitted.\20\
---------------------------------------------------------------------------

    \17\ See id.
    \18\ The Exchange states that the information provided by the
IPO Indicator is limited to the subscribing member firm's orders.
See id.
    \19\ See Notice, supra note 3, at 68746.
    \20\ See id.
---------------------------------------------------------------------------

III. Discussion and Commission Findings

    After careful review, the Commission finds that the proposed rule
change is consistent with the requirements of the Act and the rules and
regulations thereunder applicable to a national securities
exchange.\21\ In particular, the Commission finds that the proposed
rule change is consistent with Section 6(b)(5) of the Act,\22\ which
requires, among other things, that the rules of a national securities
exchange be designed to prevent fraudulent and manipulative acts and
practices, 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, and Section 6(b)(8) of the Act,\23\ which requires
that the rules of the exchange do not impose any burden on competition
not necessary or appropriate in furtherance of the purposes of the Act.
---------------------------------------------------------------------------

    \21\ In approving this proposal, the Commission has considered
the proposed rule's impact on efficiency, competition, and capital
formation. See 15 U.S.C. 78c(f).
    \22\ 15 U.S.C. 78f(b)(5).
    \23\ 15 U.S.C. 78f(b)(8).
---------------------------------------------------------------------------

    As described above, the Exchange proposes to adopt an IPO Indicator
as a new feature to the NASDAQ Workstation. The Exchange believes the
IPO Indicator would provide member firms with information consistent
with what the Exchange currently disseminates during the IPO launch
process, but as that information relates to a member firm's orders and
in greater detail.\24\ The Exchange further believes that IPO Indicator
would provide member firms and underwriters with more information
regarding their orders submitted for participation in an IPO Halt
Cross, which the Exchange believes would allow them to make better
informed investment decisions.\25\
---------------------------------------------------------------------------

    \24\ See Notice, supra note 3 at 68746.
    \25\ The Exchange notes, for example, that the IPO Indicator may
help an underwriter to make a determination to launch an IPO at a
time when the IPO security would likely pass the validation checks,
which the Exchange believes could increase the likelihood of a fair
and orderly launch of the IPO security. See id.
---------------------------------------------------------------------------

    The Commission notes that the Exchange is not proposing to increase
the fee for usage of the NASDAQ Workstation in connection with the
addition of the IPO Indicator feature. In addition, under the proposal,
the information provided by the IPO Indicator would be limited to the
subscribing member firm's orders.\26\ Accordingly, the Commission
believes that the proposed rule change adopting the IPO Indicator
feature is designed to protect investors and the public interest by
providing them with more information regarding their orders submitted
for participation in an IPO Halt Cross. Further, the new IPO Indicator
feature may also facilitate the fair and orderly launch of an IPO
security.\27\
---------------------------------------------------------------------------

    \26\ See Notice, supra note 3, at 68746.
    \27\ See supra note 25.
---------------------------------------------------------------------------

IV. Conclusion

    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\28\ that the proposed rule change (SR-NASDAQ-2014-100) be, and it
hereby is, approved.
---------------------------------------------------------------------------

    \28\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\29\
---------------------------------------------------------------------------

    \29\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Brent J. Fields,
Secretary.
[FR Doc. 2014-30809 Filed 1-2-15; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 86, Number 38 (Monday, March 1, 2021)]
[Notices]
[Page 11993]
[FR Doc No: 2021-04149]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket Nos. EL21-50-000; QF21-222-001]

Board of Trustees of Michigan State University; Notice of
Petition for Declaratory Order

    Take notice that on February 19, 2021, pursuant to Rule 207 of the
Federal Energy Regulatory Commission's (Commission) Rules of Practice
and Procedure, 18 CFR 385.207, the Board of Trustees of Michigan State
University (Petitioner), filed a petition for declaratory order
(Petition) requesting that the Commission issue a declaratory order
granting limited waiver of the filing requirements applicable to
qualifying cogeneration facilities set forth in 18 CFR Section
292.203(a)(3) of the Commission's regulations for the time period
beginning April 16, 2006, as more fully explained in the petition.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date.
Anyone filing a motion to intervene or protest must serve a copy of
that document on the Petitioner.
    In addition to publishing the full text of this document in the
Federal Register, the Commission provides all interested persons an
opportunity to view and/or print the contents of this document via the
internet through the Commission's Home Page (http://ferc.gov) using the
``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field to access the document. At this time,
the Commission has suspended access to the Commission's Public
Reference Room, due to the proclamation declaring a National Emergency
concerning the Novel Coronavirus Disease (COVID-19), issued by the
President on March 13, 2020. For assistance, contact the Federal Energy
Regulatory Commission at<EMAIL_ADDRESS>or call toll-free,
(886) 208-3676 or TYY,<PHONE_NUMBER>.
    The Commission strongly encourages electronic filings of comments,
protests and interventions in lieu of paper using the ``eFiling'' link
at http://www.ferc.gov. Persons unable to file electronically may mail
similar pleadings to the Federal Energy Regulatory Commission, 888
First Street NE, Washington, DC 20426. Hand delivered submissions in
docketed proceedings should be delivered to Health and Human Services,
12225 Wilkins Avenue, Rockville, Maryland 20852.
    Comment Date: 5:00 p.m. Eastern time on March 21, 2021.

    Dated: February 23, 2021.
Kimberly D. Bose,
Secretary.
[FR Doc. 2021-04149 Filed 2-26-21; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: May 12, 2009 (Volume 74, Number 90)]
[Notices]
[Page 22201]
[DOCID:fr12my09-77]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

The Cancelation of the Fourth Plenary Meeting, NextGen Mid-Term
Implementation Task Force

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of the Cancelation of a NextGen Mid-Term Implementation
Task Force meeting.

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SUMMARY: The FAA is issuing this notice to advise the public of the
cancelation of a meeting of the NextGen Mid-Term Implementation Task
Force.

DATES: The meeting scheduled for June 9, 2009 starting at 1 a.m. to 4
p.m. is canceled.

FOR FURTHER INFORMATION CONTACT: RTCA Secretariat, 1828 L Street, NW.,
Suite 850, Washington, DC 20036; telephone<PHONE_NUMBER>; fax (202)
833-9434; Web site http://www.rtca.org.

SUPPLEMENTARY INFORMATION: Pursuant to section 10(a)(2) of the Federal
Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., Appendix 2), notice
is hereby given for the cancelation of a NextGen Mid-Term
Implementation Task Force meeting.

    Issued in Washington, DC, on May 4, 2009.
Francisco Estrada C.,
RTCA Advisory Committee.
[FR Doc. E9-10984 Filed 5-11-09; 8:45 am]

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[Federal Register Volume 85, Number 239 (Friday, December 11, 2020)]
[Notices]
[Pages 80114-80116]
[FR Doc No: 2020-27248]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2019-D-1647, FDA-2019-D-1652, and FDA-2019-D-1650]

Performance Criteria for Safety and Performance Based Pathway;
Guidances for Industry and Food and Drug Administration Staff;
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of three device-specific final guidance documents for
the Safety and Performance Based Pathway--specifically, ``Spinal
Plating Systems--Performance Criteria for Safety and Performance Based
Pathway; Guidance for Industry and Food and Drug Administration
Staff,'' ``Orthopedic Non-Spinal Metallic Bone Screws and Washers--
Performance Criteria for Safety and Performance Based Pathway; Guidance
for Industry and Food and Drug Administration Staff,'' and ``Magnetic
Resonance (MR) Receive-only Coil--Performance Criteria for Safety and
Performance Based Pathway; Guidance for Industry and Food and Drug
Administration Staff.'' The device-specific guidances identified in
this notice were developed in accordance with the final guidance
entitled ``Safety and Performance Based Pathway.''

DATES: The announcement of the guidances is published in the Federal
Register on December 11, 2020.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2019-D-1647 for ``Spinal Plating Systems--Performance Criteria for
Safety and Performance Based Pathway; Guidance for Industry and Food
and Drug Administration Staff,'' Docket No. FDA-2019-D-1652 for
``Orthopedic Non-Spinal Metallic Bone Screws and Washers--Performance
Criteria for Safety and Performance Based Pathway; Guidance for
Industry and Food and Drug Administration Staff,'' and Docket No. FDA-
2019-D-1650 for ``Magnetic Resonance (MR) Receive-only Coil--
Performance Criteria for Safety and Performance Based Pathway; Guidance
for Industry and Food and Drug Administration Staff.'' Received
comments will be placed in the docket and, except for those submitted
as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff

between 9 a.m. and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    An electronic copy of the guidance documents are available for
download from the internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidances. Submit written
requests for a single hard copy of the guidance document entitled
``Spinal Plating Systems--Performance Criteria for Safety and
Performance Based Pathway; Guidance for Industry and Food and Drug
Administration Staff,'' ``Orthopedic Non-Spinal Metallic Bone Screws
and Washers--Performance Criteria for Safety and Performance Based
Pathway; Guidance for Industry and Food and Drug Administration
Staff,'' or ``Magnetic Resonance (MR) Receive-only Coil--Performance
Criteria for Safety and Performance Based Pathway; Guidance for
Industry and Food and Drug Administration Staff'' to the Office of
Policy, Guidance and Policy Development, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-0002. Send one self-
addressed adhesive label to assist that office in processing your
request.

FOR FURTHER INFORMATION CONTACT: Jason Ryans, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1613, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    These device-specific guidance documents provide performance
criteria for premarket notification (510(k)) submissions to support the
optional Safety and Performance Based Pathway, as described in the
guidance entitled ``Safety and Performance Based Pathway.'' \1\ As
described in that guidance, substantial equivalence is rooted in
comparisons between new devices and predicate devices. However, the
Federal Food, Drug, and Cosmetic Act does not preclude FDA from using
performance criteria to facilitate this comparison. If a legally
marketed device performs at certain levels relevant to its safety and
effectiveness, and a new device meets those levels of performance for
the same characteristics, FDA could find the new device as safe and
effective as the legally marketed device. Instead of reviewing data
from direct comparison testing between the two devices, FDA could
support a finding of substantial equivalence with data demonstrating
the new device meets the level of performance of an appropriate
predicate device(s). Under this optional Safety and Performance Based
Pathway, a submitter could satisfy the requirement to compare its
device with a legally marketed device by, among other things,
independently demonstrating that the device's performance meets
performance criteria as established in the above-listed guidances,
rather than using direct predicate comparison testing for some of the
performance characteristics.
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    \1\ Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/safety-and-performance-based-pathway.
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    A notice of availability of the draft guidances ``Spinal Plating
Systems'' and ``Orthopedic Non-Spinal Metallic Bone Screws and
Washers'' appeared in the Federal Register of September 20, 2019 (84 FR
49528). A notice of availability of the draft guidance ``Magnetic
Resonance Coil'' appeared in the Federal Register of December 9, 2019
(84 FR 67272). FDA considered comments received on the ``Spinal Plating
Systems'' guidance and revised the guidance as appropriate by
clarifying the types of plates that are excluded from the scope of the
guidance (i.e., occipital plates) and the lack of a specified minimum
plate thickness. FDA considered comments received on the ``Orthopedic
Non-Spinal Metallic Bone Screws and Washers'' guidance and revised the
guidance as appropriate by expanding the scope of appropriate
materials, clarifying the type of appropriate screw and washer design
features, and clarifying the expectations for performance test methods
and criteria. FDA considered comments received on the ``Magnetic
Resonance Coil'' guidance and revised the guidance as appropriate by
clarifying that the guidance is intended for receive-only magnetic
resonance coils, expanding performance test methods with applicable
FDA-recognized consensus standards, and clarifying the relation between
performance testing and evaluations of interoperability.
    These guidances are being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The guidances represent
the current thinking of FDA on performance criteria for ``Spinal
Plating Systems,'' ``Orthopedic Non-Spinal Metallic Bone Screws and
Washers,'' and ``Magnetic Resonance Coil.'' They do not establish any
rights for any person and are not binding on FDA or the public. You can
use an alternative approach if it satisfies the requirements of the
applicable statutes and regulations.

II. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so by
downloading an electronic copy from the internet. A search capability
for all Center for Devices and Radiological Health guidance documents
is available at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-/assistance/guidance-documents-medical-devices-and-radiation-emitting-products. These guidance documents are
also available at https://www.regulations.gov and at https://www.fda.gov/regulatory-information/search-fda-guidance-documents.
Persons unable to download an electronic copy of either ``Spinal
Plating Systems--Performance Criteria for Safety and Performance Based

Pathway; Guidance for Industry and Food and Drug Administration Staff''
(document number 19008), ``Orthopedic Non-Spinal Metallic Bone Screws
and Washers--Performance Criteria for Safety and Performance Based
Pathway; Guidance for Industry and Food and Drug Administration Staff''
(document number 19009), or ``Magnetic Resonance (MR) Receive-only
Coil--Performance Criteria for Safety and Performance Based Pathway;
Guidance for Industry and Food and Drug Administration Staff''
(document number 19011) may send an email request to<EMAIL_ADDRESS>to receive an electronic copy of the document.
Please use the document number and complete title to identify the
guidance you are requesting.

III. Paperwork Reduction Act of 1995

    While these guidances contain no collection of information, they do
refer to previously approved FDA collections of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for these guidances. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information in the following FDA regulations and guidance have been
approved by OMB as listed in the following table:

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                 21 CFR part or guidance                                 Topic                  OMB control No.
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807, subpart E..........................................  Premarket notification.............          0910-0120
``Requests for Feedback on Medical Device Submissions:    Q-submissions......................          0910-0756
 The Pre-Submission Program and Meetings with Food and
 Drug Administration Staff``.
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    Dated: December 7, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-27248 Filed 12-10-20; 8:45 am]
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