EPA REGISTRATION DIVISION COMPANY NOTICE OF FILING FOR PESTICIDE PETITIONS PUBLISHED IN THE FEDERAL REGISTER

EPA Registration Division contact: [Mr. Dominic Schuler,<PHONE_NUMBER>]

INSTRUCTIONS:  Please utilize this outline in preparing the pesticide petition.  In cases where the outline element does not apply, please insert "NA-Remove" and maintain the outline. Please do not change the margins, font, or format in your pesticide petition. Simply replace the instructions that appear in green, i.e., "[Company Name]," with the information specific to your action.

TEMPLATE:

BASF Corporation

PP#3F8163

	EPA has received a pesticide petition (PP#3F8163 ) from BASF Corporation, 26 Davis Drive, Research Triangle Park, NC 27709 proposing, pursuant to section 408(d) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part 180.624 by establishing a tolerance for residues of metrafenone ((3-bromo-6-methoxy-2-methylphenyl)(2,3,4-trimethoxy-6-methylphenyl)methanone) in or on the raw agricultural commodity Fruits, pome, group 11-10 at 1.5 parts per million (ppm). EPA has determined that the petition contains data or information regarding the elements set forth in section 408 (d)(2) of  FDDCA; however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data supports granting of the petition. Additional data may be needed before EPA rules on the petition.

A. Residue Chemistry

	1. Plant metabolism. [In plant metabolism studies conducted in grapevines with metrafenone, the parent compound was the principal residue in grapes.  Metrafenone is metabolized through methyl and ring oxidative bio-transformations, followed by enzymatic glucoside conjugation reactions to yield the conjugates from their corresponding aglycons.  All major metabolites, which were present at very low levels, are considered non-relevant as all were detected in the rat metabolism study as aglycons or conjugates, and can therefore be considered as not toxicologically significant.  Thus, only parent metrafenone is considered relevant to define the residue in plants.

The results from a hydrolysis study designed to simulate different industrial and household processes (pasteurization, brewing, boiling and sterilization) showed that metrafenone is stable.  Therefore, metrafenone as unchanged parent is proposed as the relevant residues in grapes and industrial or household preparations of grapes.]

	2. Analytical method. [The residues of parent metrafenone in/on apple and pear RAC samples were quantitated using an LC/MS/MS multi-residue QuEChERS method (BASF Study No. 398340).  The method was successfully validated on apples in conjunction with this study prior to analysis of the field samples.  Acceptable concurrent method recovery data for pome fruit RAC samples were also obtained for metrafenone.  The validated limit of quantitation (LOQ) for residues of metrafenone in/on pome fruits RAC samples was 0.01 ppm.  The method limit of detection (LOD) was 0.003 ppm, or approximately 30% of the LOQ. An independent laboratory validation demonstrated good performance of the QuEChERS method.]

	3. Magnitude of residues. [BASF has submitted field trial data for metrafenone (BAS 560 F) on representative crops (apple and pear) of the pome fruits crop group (EPA Crop Group 11-10).  A total of 18 trials was conducted on pome fruits during the 2010 growing season:  twelve trials on apple in EPA Regions 1 (NY, two trials; PA, one trial), 2 (VA, one trial), 5 (MI, WI, one trial each), 9 (UT, one trial), 10 (CA, one trial), and 11 (ID, WA, two trials each), and six trials on pear in EPA Regions 1 (NY, one trial), 10 (CA, two trials), and 11 (ID, two trials; WA, one trial). The number and locations of field trials are in accordance with OPPTS Guideline 860.1500. Field trials were carried out using the maximum label rates, the maximum number of applications, and the minimum pre-harvest interval (PHI) for all the crops.

An apple processing study was conducted to determine the potential for concentration of residues of metrafenone (BAS 560 F) in the processed fractions of apple.  Two trials were conducted in EPA Regions 1 (NY, one trial) and 11 (ID, one trial) during the 2010 growing season. The apple RAC samples were separately processed using simulated commercial processing procedures into the currently EPA-regulated commodities of apple, wet pomace and juice.  Apple sauce, canned apples, and dried apples were also generated and collected for analysis.  A comparison of the residues in the RAC samples with those in each processed fraction indicated that metrafenone residues do not concentrate appreciably (processing factors <1 to 1.2, average of two trials) in any apple processed commodities, with the exception of apple sauce, in which the processing factor was 4.5x on average, with individual results of 4.8x and 4.1x calculated from the samples collected at the sites in New York and Idaho, respectively.

B. Toxicological Profile

	1. Acute toxicity.  [In an acute toxicity study with rats, metrafenone was practically non-toxic (EPA Tox. Category IV).  In an acute neurotoxicity study with rats, no signs of neurotoxicity were detected up to 2,000 mg/kg b.w., the highest dose tested.]

	2. Genotoxicty. [metrafenone was evaluated for its potential genotoxicity in vitro using bacterial and mammalian cell mutagenicity tests and a chromosome damage (clastogenicity) test.  The results of these studies demonstrated the absence of a genotoxic effect.  In vivo, the test substance was assessed for the induction of micronuclei in mice. The result of this study showed that metrafenone has no chromosome-damaging potential.

It is therefore concluded, that metrafenone has no mutagenic or genotoxic properties both in vitro and in vivo.]

	3. Reproductive and developmental toxicity. [The reproductive and developmental toxicity of metrafenone was investigated in a 2-generation reproduction study in rats as well as in prenatal toxicity studies in rats and rabbits.

In the definitive 2-generation reproduction study in rats, the NOAEL for fertility and reproduction was 10,000 ppm (the highest concentration tested), equivalent to approximately 811 mg/kg b.w./day based on food consumption data during the premating periods. The parental NOAEL of metrafenone is 500 ppm (approximately 39 mg/kg b.w./day based on food consumption data).  The 1,000 ppm treatment showed statistically significant decreases in body weight and weight gain in F1 parental males and increased absolute and relative liver weights in females.  The NOAEL for pup (offspring) toxicity was 1,000 ppm (approximately 79 mg/kg b.w./day based on food consumption data); the 10,000 ppm treatment showed a statistically significant decrease in pup body weight (31%) during lactation, an increase in relative liver weights at weaning, and a delay in vaginal opening (F1 only).

In the prenatal toxicity study in rats, there was no treatment-related maternal or developmental toxicity observed, even at the highest dose tested (1,000 mg/kg b.w./day). On the basis of these data, the maternal NOAEL of metrafenone is 1,000 mg/kg b.w./day (highest dose tested).  The 1,000 mg/kg b.w./day dose showed a statistically significantly increased ratio of liver weight to terminal body weights.  However, no correlating microscopic changes were diagnosed, indicating that the increased relative liver weight was not considered toxicologically significant.  The developmental NOAEL for metrafenone is 1,000 mg/kg b.w./day (no effects were observed at the highest dose tested).  Based on the above results, metrafenone is not selectively toxic to the fetus.  In addition, metrafenone was not teratogenic in rats.

In the rabbit prenatal toxicity study, developmental toxicity was observed in the presence of maternal toxicity. Specifically, the maternal NOAEL is 50 mg/kg b.w./day based on the following: reduced body weight gains and reduced feed consumption (absolute and relative) at both 350 and 700 mg/kg b.w./day.  In addition, at these two dose levels, a dose-related, statistically significant increase in absolute and relative (to body weight) liver weights occurred, as compared to controls.  Also, increased incidences and/or severities of periportal hepatocellular hypertrophy and diffuse and/or periportal hepatocellular vacuolation were observed at 350 and 700 mg/kg b.w./day.  In this prenatal toxicity study in rabbits, the developmental NOAEL of metrafenone is 350 mg/kg b.w./day, as based on the slight but statistically significant reduction in fetal body weights at 700 mg/kg b.w./day.  Therefore, because developmental toxicity was only observed at dose levels that were maternally toxic, metrafenone is not selectively toxic to the fetus.  In addition, metrafenone was not teratogenic in rabbits.

Overall, for the reproductive and developmental toxicity studies, the lowest NOAEL for maternal/parental toxicity was 39 mg/kg b.w./day (two-generation reproduction study) and for pup toxicity was 79 mg/kg b.w./day (two-generation reproduction study).]

	4. Subchronic toxicity. [The subchronic toxicity of metrafenone was investigated in a dietary 28-day study in rats, a 28-day oral toxicity study in dogs, and 3-month toxicity studies in rats, mice, and dogs.  In addition, a 28-day neurotoxicity study, as well as a 28-day immunotoxicity study were conducted with rats.

The signs of toxicity observed in the three species tested were overall similar and consisted of reduced body weight gain at the highest tested dose levels.  The observed effects on clinical chemistry in rats and mice can be linked to the microscopic effects observed in the liver.  The effects observed typically included increased cholesterol, total protein, and total bilirubin (mice only).  Organ weights and/or pathology indicated the liver to be the only consistent target organ in all three species tested.  The changes included, periportal cytoplasmic vacuolation in rats, centrilobular hepatocellular hypertrophy in mice, and increased liver weights in rats, mice, and dogs.

In the 28-day neurotoxicity study with rats, there was no evidence of neurotoxicity in all treatment groups, with a No-Observed-Adverse-Effect Level (NOAEL) for neurotoxicity of 15,000 in the diet (equivalent to 1,371 mg/kg b.w./day for both sexes, as based on food consumption data, which exceeds a limit dose of 1,000 mg/kg b.w./day).  These results, coupled with the lack of neurotoxic effects observed in acute, sub-chronic and chronic studies with other species, indicate that metrafenone is not potentially neurotoxic.

In the 28-day immunotoxicity study with female rats, there was no evidence of immunotoxicity in all treatment groups, with a No-Observed-Adverse-Effect Level (NOAEL) for immunotoxicity of 12,000 in the diet (equivalent to 1,086 mg/kg b.w./day, as based on food consumption data, which exceeds a limit dose of 1,000 mg/kg b.w./day).  These results, coupled with the lack of immunotoxic effects observed in acute, sub-chronic and chronic studies with other species, indicate that metrafenone is not potentially immunotoxic.]

	5. Chronic toxicity. [The chronic toxicity of metrafenone was evaluated in a 1-year oral administration study in dogs, a 24-month feeding study with rats and an 18-month feeding study with mice.

Administration of metrafenone to dogs for one year resulted in mild increases in mean alkaline phosphatase in males after 9 and 12 months of dosing at 500 mg/kg b.w./day (highest dose tested).  Mean absolute and relative liver weights were both statistically significantly increased in females at 500 mg/kg b.w./day and relative liver weights were statistically significantly increased in males at 500 mg/kg b.w./day.  However, there were no associated macroscopic or microscopic findings in the livers of these animals.  Therefore, the slight but statistically significant differences in liver weights and alkaline phosphatase (in males) were not considered to be of toxicological significance.  All other parameters evaluated including mortality, clinical observations, body weights and food consumption data, ophthalmology, hematology, coagulation and urinalysis data, and macroscopic and microscopic examinations revealed no adverse effects due to administration of metrafenone.  Therefore, the NOAEL for oral administration of metrafenone to pure-bred Beagle Dogs was 500 mg/kg b.w./day, the highest dose tested.

Treatment of Sprague-Dawley rats with metrafenone for 24 months resulted in markedly reduced body weight gains in females at 5,000 (26%) and 20,000/10,000 ppm (42%) and a lesser reduction in body weight gain for males at 20,000 ppm (14%).  Microscopic effects in the liver and kidney were associated with clinical chemistry changes in males and females at doses of 5,000 ppm and greater.  Slight anemia was observed in females at 5,000 ppm and higher, which was reversed at 24 months.  An increase in the incidence of hepatocellular necrosis after 12 months and benign hepatocellular adenomas was observed in females at 5,000 ppm and greater which are dietary concentrations that exceeded the MTD.  Therefore, the NOAEL for systemic toxicity and for oncogenic effects following dietary administration of metrafenone to Sprague-Dawley rats for 24 months, was 500 ppm (25 mg/kg b.w./day as based on food consumption data).

Treatment of albino mice with metrafenone for 18 months resulted in statistically significant increases in the following: liver weights (absolute and relative, in females), hepatocellular hypertrophy in males, renal chronic nephropathy in males and extramedullary hematopoiesis in the spleen of females at 1,000 ppm, the next highest concentration tested. Therefore, the NOAEL for systemic toxicity following dietary administration of metrafenone to albino mice for 18 months, was 250 ppm (46 mg/kg b.w./day as based on food consumption data).

A statistically significant (P<0.01) increase in the incidence of hepatocellular neoplasms (adenomas and carcinomas) was observed in the livers of male mice receiving 7,000 ppm (19/66, 28.8%), as compared to controls (6/65, 9.2%).  There was also a marginal increase in the incidence of hepatocellular neoplasms in females receiving 7,000 ppm (4/65), as compared to the control mice (2/65). The incidence of 14/66 (21.2%) hepatocellular adenoma for males at 7,000 ppm is slightly above the maximum range of historical control data at the testing laboratory (14.8%) and at Charles River Laboratories (19.2%).  The incidence of 5/66 (7.6%) hepatocellular carcinoma in males at 7,000 ppm is within the maximum range of historical control data at both the testing facility (9.2%) and Charles River Laboratories (11.5%).  Although the number of hepatocellular neoplasms in males receiving 1,000 ppm was also slightly increased (9/65, 13.8%) compared to the untreated controls (6/65, 9.2%), this slight increase was not statistically significant (p<0.05) and was within the range of the historical controls (9.2-18.5%) at the testing laboratory.  The slight increase in hepatocellular neoplasms in male mice at 1,000 ppm may have resulted from increased survival observed at termination in male mice at 1,000 ppm as compared to controls (55 versus 45 in the surviving male controls).  The incidences of hepatocellular neoplasms in terminally sacrificed male mice were 5/45 or 11%, 3/53 or 6%, 8/55 or 15% and 18/54 or 33%, at respective treatment levels of 0, 250, 1,000 and 7,000 ppm.

For females, whereas the incidence of hepatocellular adenoma was the same (2/65 or 3.1%) at 7,000 ppm and for controls, the incidence of hepatocellular carcinoma was slightly increased at 7,000 ppm (2/65 or 3.1%) versus control (0/65 or 0%).  Since this incidence of hepatocellular carcinoma (3.1%) for females at 7,000 ppm is slightly above the maximum range of historical control data at both the testing facility (1.5%) and Charles River Laboratories (2.0%), the incidence represents an equivocal finding.  However, because this increase was very small, was not statistically significant, and did not demonstrate decreased latency compared to the controls, this finding was considered to represent only equivocal toxicologic significance.

Therefore, based on the weight-of-the-evidence analysis, the NOAEL for oncogenicity is 1,000 ppm (approximately 190 mg/kg of b.w./day, calculated from food consumption data and nominal concentrations) based on the increased incidence of hepatocellular neoplasms observed in male mice at 7,000 ppm, as compared to controls.

In summary, long-term exposure studies with metrafenone in dogs, rats and mice resulted in increased liver weights with corresponding changes in clinico-chemical parameters.  Microscopic pathological changes were identified in the liver, kidney, and spleen for rats and/or mice. The main target organ was identified as the liver in all species.  Additionally, increased incidences of primary hepatocellular neoplasms were observed at the highest doses in rats and mice.]

	6. Animal metabolism. [Metrafenone was rapidly absorbed and efficiently excreted following oral administration in the rat.  The amount of absorption ranged from approximately 89 to 92% of the administered dose of 10 mg/kg b.w.  Most of  the administered dose was eliminated via bile within 72 hours (85.2 to 90.1%) and feces within 7 days (84.1 to 98.8%), with a small amount (0.69 to 6.6%) in urine.  metrafenone-related residues showed no potential for accumulation as <1.2% of the applied dose was retained over seven days, with highest levels of residues found in the liver, GI tract, plasma, blood, kidney, and fat.  The tissue retention of the orally administered dose was less than 2% at 48-72 hours and less than 1.2% at 168 hours.  metrafenone was extensively metabolized in the rat to multiple metabolites formed via demethylation of the aromatic methoxy-group(s) followed by mono-O-glycosidation, hydroxylation of the bromophenyl ring, and hydroxylation of the methyl substituent to hydroxymethyl followed by O-glycosidation or further oxidation to aldehyde or lactone.]

	7. Metabolite toxicology. [In plant metabolism studies conducted in grapevines with metrafenone, the parent compound was the principal residue in grapes.  metrafenone is metabolized through methyl and ring oxidative biotransformations, followed by enzymatic glucoside conjugation reactions to yield the conjugates from their corresponding aglycons.  All major metabolites, which were present at very low levels, are considered non-relevant as all were detected in the rat metabolism study as aglycons or conjugates, and can therefore be considered as not toxicologically significant.  Thus, only parent metrafenone is considered relevant to define the residue in plants.

The results from a hydrolysis study designed to simulate different industrial and household processes (pasteurization, brewing, boiling and sterilization) showed that metrafenone is stable.  Therefore, metrafenone as unchanged parent is proposed as the relevant residue in grapes and industrial or household preparations of grapes.

Since metrafenone is not registered for use in the United States, the toxicity of metabolites formed in matrices other than the raw or processed treated commodity (e.g., water, soil) is not relevant.]

	8. Endocrine disruption. [Data from the reproduction / developmental toxicity and short- and long-term repeated dose toxicity studies with metrafenone in the rat, rabbit, mouse, or dog, do not suggest any endocrine disruption activity.  This information is based on the absence of any treatment-related effects from the histopathological examination of endocrine organs as well as the low level of concern for possible effects on fertility, reproductive performance, or any other aspect of reproductive function, or on growth and development of the offspring.]

C. Aggregate Exposure

	1. Dietary exposure. [Assessments were conducted to evaluate the potential risk due to chronic dietary exposure of the U.S. population to residues of metrafenone.  The U.S. EPA has not established an acute reference dose for either the general population or females ages 13  -  49 years because no study demonstrated evidence of toxicity from a single dose exposure for these populations.  Therefore, an acute exposure risk evaluation is not required.  The chronic assessment was conducted using all currently established tolerances for metrafenone listed in 40CFR180.624 and the proposed new tolerance for the Pome Fruit Crop Group 11-10 of 1.5 ppm.   ]

	i. Food. [The dietary assessment analysis followed an initial tier approach using 100% crop treated, and current tolerance values for grapes and raisins and the proposed new tolerance for the Pome Fruit Crop Group 11-10 of 1.5 ppm.   Dietary exposure assessments were conducted using Dietary Exposure Evaluation Module (DEEM-FCID Ver 3.12).
Acute Dietary Exposure Assessment
An acute assessment was not conducted because there are no relevant toxicological endpoints for acute dietary exposure and a risk assessment is not required.

Chronic Dietary Exposure Assessment
Results of the chronic exposure estimates were compared against the chronic Population Adjusted Dose (cPAD) of 0.25 mg/kg b.w./day  that was based on the NOAEL from the rat chronic toxicity study, a safety factor of 100, and no additional FQPA safety factor is required.

Results of the chronic dietary exposure assessments are listed in Table 1.  The estimated chronic dietary exposure from imported grapes was less than 11% of the cPAD for all subpopulations.

	Table 1.  Chronic Dietary Food Exposure Assessment for Metrafenone.
                                  Population
                               Exposure Estimate
                                     %cPAD
                                   Subgroups
                               (mg/kg b.w./day)

                                 US Population
                                   0.003669
                                      1.5
                           All infants (< 1 year)
                                   0.020536
                                      8.2
                                 Children 1-2
                                   0.027148
                                     10.9
                                 Children 3-5
                                   0.014828
                                      5.9
                                 Children 6-12
                                   0.005949
                                      2.4
                                  Youth 13-19
                                   0.001885
                                      0.8
                                 Adults 20-49
                                   0.001546
                                      0.6
                                Adults 50+ yrs
                                   0.001961
                                      0.8
                              Females 13 - 49 yrs
                                   0.001743
                                      0.7

The results in Table 1 demonstrate there are no safety concerns for any subpopulation based on established and new uses, and that the results clearly meet the FQPA standard of reasonable certainty of no harm.]

	ii. Drinking water. [The drinking water exposure values used in this assessment are from the most recent U.S. EPA risk assessment for Grapes (U.S. EPA, March 1, 2010 "Metrafenone: Human Health Risk Assessment for Foliar Use on Grape").  The water values calculated by EPA are the higher values than the proposed use on pome fruit.  The chronic surface water concentration used in the human exposure assessment was 22.82 ug/L.

Drinking water contributions were assessed based on a metrafenone water concentration of 22.82 ug/L for chronic exposure and water consumption and body weights reported in CSFII, using DEEM-FCID Ver 3.12 software.  The chronic estimated water exposure values are summarized in Table 2.

Table 2. Summary of chronic dietary exposure assessment for drinking water considering direct and indirect sources.
                                  Population
                                   Subgroups
                               Exposure Estimate
                               (mg/kg b.w./day)
                                     %cPAD
US Population
                                   0.000478
                                      0.2
All infants (< 1 year)
                                   0.001232
                                      0.5
Children 1-2
                                   0.000689
                                      0.3
Children 3-5
                                   0.000581
                                      0.2
Children 6-12
                                   0.000419
                                      0.2
Youth 13-19
                                   0.000348
                                      0.1
Adults 20-49
                                   0.000477
                                      0.2
Adults 50+ yrs
                                   0.000471
                                      0.2
Females 13 - 49 yrs
                                   0.000475
                                      0.2
%cPAD = percent of chronic population adjusted dose
Exposure based on the maximum estimated water concentration of 22.82 ug/L

Acute Aggregate Exposure (Food + Water)
An acute assessment was not needed because there are no relevant toxicological endpoints for acute dietary exposure and an aggregate risk assessment is not required.

Short- and Intermediate Aggregate Exposure (Food + Water + Residential)
Metrafenone is not registered for any use which will result in residential exposure.  Therefore, a short- or intermediate-term exposure and aggregate risk evaluation is not required.

Chronic Aggregate Exposure (Food + Water)
The aggregate chronic risk includes residues of metrafenone from food and water (Table 3).  The results demonstrate there are no safety concerns for any subpopulation based on established and new uses, and that the results clearly meet the FQPA standard of reasonable certainty of no harm.

Table 3. Estimated chronic aggregate exposure and risk of Metrafenone
                              Population Subgroup
                               cPAD (mg/kg/day)
                  Total Exposure, Food and Water (mg/kg/day)
                                    % cPAD
US Population
                                     0.25
                                   0.004147
                                      1.7
All infants (< 1 year)
                                     0.25
                                   0.021768
                                      8.7
Children 1-2
                                     0.25
                                   0.027837
                                     11.1
Children 3-5
                                     0.25
                                   0.015409
                                      6.2
Children 6-12
                                     0.25
                                   0.006368
                                      2.5
Youth 13-19
                                     0.25
                                   0.002233
                                      0.9
Adults 20-49
                                     0.25
                                   0.002023
                                      0.8
Adults 50+ yrs
                                     0.25
                                   0.002432
                                      1.0
Females 13 - 49 yrs
                                     0.25
                                   0.002218
                                      0.9

]

	2. Non-dietary exposure. [Metrafenone is not registered for any use which will result in non-dietary residential exposure.]

D. Cumulative Effects

	[At this time, there is no available information to indicate that metrafenone or its metabolites have a common mechanism of toxicity with other substances.  Therefore, there is no reason to include this pesticide or its metabolites in a cumulative risk assessment.  For the purposes of this tolerance action EPA has not assumed that metrafenone and its metabolites have a common mechanism of toxicity with other substances.  ]

E. Safety Determination

	1. U.S. population. [Results of the dietary exposure analysis demonstrate with reasonable certainty that no harm to the general U.S. population or any subpopulation would results from the use of metrafenone on the current and proposed uses.]

	2. Infants and children. [Results of the dietary exposure analysis demonstrate with reasonable certainty that no harm to the general U.S. population or any subpopulation, including infants and children, would results from the use of metrafenone on the current and proposed uses. ]

F. International Tolerances

	[No maximum residue levels (MRLs) have been established for metrafenone by the Codex Alimentarius Commission (CODEX) or in Mexico.]


[Federal Register Volume 79, Number 3 (Monday, January 6, 2014)]
[Notices]
[Pages 695-697]
[FR Doc No: 2013-31553]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Notice of Passenger Facility Charge (PFC) Approvals and
Disapprovals

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Monthly Notice of PFC Approvals and Disapprovals. In October
2013, there were four applications approved. This notice also includes
information on two applications, one approved in January 2012 and the
other approved in September 2013, inadvertently left off the January
2012 and September 2013 notices, respectively. Additionally, 12
approved amendments to previously approved applications are listed.

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

SUMMARY: The FAA publishes a monthly notice, as appropriate, of PFC
approvals and disapprovals under the provisions of the Aviation Safety
and Capacity Expansion Act of 1990 (Title IX of the Omnibus Budget
Reconciliation Act of 1990) (Pub. L. 101-508) and Part 158 of the
Federal Aviation Regulations (14 CFR Part 158). This notice is
published pursuant to paragraph d of Sec.  158.29.

PFC Applications Approved

    Public Agency: City of Burlington, Vermont.
    Application Number: 11-05-C-00-BTV.
    Application Type: Impose and use a PFC.
    PFC Level: $4.50.
    Total PFC Revenue Approved in This Decision: $5,240,755.
    Earliest Charge Effective Date: April 1, 2014.
    Estimated Charge Expiration Date: February 1, 2016.
    Class of Air Carriers Not Required to Collect PFC's: On-demand air
taxi commercial operators.
    Determination: Approved. Based on information contained in the
public agency's application, the FAA has determined that the approved
class accounts for less than 1 percent of the total annual enplanements
at Burlington International Airport.
    Brief Description of Projects Approved for Collection and Use:

Snow removal equipment purchase.
Rehabilitate a portion of the cargo apron.
Terminal building renovation.
Land acquisition for noise abatement.
Land acquisition for development.
Reconstruct, mark and light taxiway A north.
Storm water management plan.
Security projects.

Airport master plan and airport layout plan updates.
Runway 15-33 pavement evaluation and rehabilitate study.
North terminal and apron--phase 2 and glycol deicing system.
Noise study and noise compatibility study.
Taxiway lighting.
Reconstruct and mark runway 15/33.
Extend runway 19 and taxiway A.
PFC application costs.
Reconstruct, mark and light a portion of taxiway C.
    Brief Description of Project Partially Approved for Collection and
Use:

South end development projects.
    Determination: Partially approved. One of the proposed components
of this project was also requested under a different project in this
application. The component, acquisition of the Roberts land, was
approved under the project titled ``land acquisition for development''
above and is disallowed in this project.
    Brief Description of Withdrawn Project:

Taxiway G extension and taxiway B reconstruction.
    Date of Withdrawal: January 20, 2012.
    Decision Date: January 31, 2012.

FOR FURTHER INFORMATION CONTACT: Priscilla Scott, New England Region
Airports Division,<PHONE_NUMBER>.

    Public Agency: County of Campbell/Gillette-Campbell County Airport
Board, Gillette, Wyoming.
    Application Number: 13-09-C-00-GCC.
    Application Type: Impose and use a PFC.
    PFC Level: $4.50.
    Total PFC Revenue Approved in This Decision: $405,826.
    Earliest Charge Effective Date: October 1, 2014.
    Estimated Charge Expiration Date: December 1, 2017.
    Class of Air Carriers Not Required to Collect PFC's: Air taxi/
commercial operators filing FAA Form 1800-31.
    Determination: Approved. Based on information contained in the
public agency's application, the FAA has determined that the approved
class accounts for less than 1 percent of the total annual enplanements
at Gillette-Campbell County Airport.
    Brief Description of Projects Approved for Collection and Use:

Acquire snow removal equipment.
Realign airport access road.
PFC administration.
    Decision Date: September 27, 2013.

FOR FURTHER INFORMATION CONTACT: Jesse Lyman, Denver Airports District
Office,<PHONE_NUMBER>.

    Public Agency: Metropolitan Nashville Airport Authority, Nashville,
Tennessee.
    Application Number: 13-19-C-00-BNA.
    Application Type: Impose and use a PFC.
    PFC Level: $4.50.
    Total PFC Revenue Approved in this Decision: $4,430,000.
    Earliest Charge Effective Date: August 1, 2017.
    Estimated Charge Expiration Date: November 1, 2017.
    Class of Air Carriers Not Required to Collect PFC's: Air taxi/
commercial operators filing FAA Form 1800-31 and operating at Nashville
International Airport (BNA).
    Determination: Approved. Based on information contained in the
public agency's application, the FAA has determined that the approved
class accounts for less than 1 percent of the total annual enplanements
at BNA.
    Brief Description of Project Approved for Collection and Use at a
$4.50 PFC Level:

Reconstruct runway 13/31 west.

    Brief Description of Projects Approved for Collection and Use at a
$3.00 PFC Level:

Improve storm water collection and treatment system.
Operations 14 CFR Part 139 online training and 49 CFR Part 1542.
    Decision Date: October 3, 2013.

FOR FURTHER INFORMATION CONTACT: Cynthia Wills, Memphis Airports
District Office,<PHONE_NUMBER>.

    Public Agency: Phoenix--Mesa Gateway Airport Authority, Mesa,
Arizona.
    Application Number: 13-03-C-00-IWA.
    Application Type: Impose and Use a PFC.
    PFC Level: $4.50.
    Total PFC Revenue Approved in this Decision: $23,927,638.
    Earliest Charge Effective Date: July 1, 2017.
    Estimated Charge Expiration Date: January 1, 2023.
    Class of Air Carriers not Required to Collect PFC's: None.
    Brief Description of Projects Approved for Collection and Use:

Environmental assessment for the northeast terminal.
Benefit cost analysis for the northeast terminal development.
Construct taxilane L extension--phase II.
Construct Alpha apron expansion--phase III.
Construct paralle taxiway C extension--phase II.
PFC administration costs.

    Brief Description of Projects Approved for Use:

Design/construct fuel farm expansion.
Design/reconstruct taxiway P.

    Brief Description of Project Approved for Collection:

West terminal expansion--phase IV.

    Brief Description of Disapproved Project:

Conduct airport surveillance radar relocation study.

    Determination: Disapproved. The FAA determined that this study does
not meet the requirements of Sec.  158.15(b)(2).
    Decision Date: October 11, 2013.

FOR FURTHER INFORMATION CONTACT: Darlene Williams, Los Angeles Airports
District Office,<PHONE_NUMBER>.

    Public Agency: City and County of San Francisco, San Francisco,
California.
    Application Number: 11-05-C-00-SFO.
    Application Type: Impose and use a PFC.
    PFC Level: $4.50.
    Total PFC Revenue Approved in This Decision: $610,451,805.
    Earliest Charge Effective Date: January 1, 2017.
    Estimated Charge Expiration Date: June 1, 2023.
    Class of Air Carriers not Required to Collect PFC's: Nonscheduled/
on-demand air carriers filing FAA Form 1800-31 and operating at San
Francisco International Airport (SFO).
    Determination: Approved. Based on information contained in the
public agency's application, the FAA has determined that the approved
class accounts for less than 1 percent of the total annual enplanements
at SFO.
    Brief Description of Projects Approved for Collection and Use:

Terminal 2 and boarding area D renovations.

    Decision Date: October 11, 2013.

FOR FURTHER INFORMATION CONTACT: Neil Kumar, San Francisco Airports
District Office,<PHONE_NUMBER>.

    Public Agency: Tulsa Airports Improvement Trust, Tulsa, Oklahoma.
    Application Number: 13-09-C-00-TUL.
    Application Type: Impose and use a PFC.
    PFC Level: $4.50.
    Total PFC Revenue Approved in This Decision: $54,675,000.
    Earliest Charge Effective Date: October 1, 2022.
    Estimated Charge Expiration Date: April 1, 2033.

    Class of Air Carriers Not Required to Collect PFC's: Air taxi/
commercial operators filing FAA Form 1800-31.
    Determination: Approved. Based on information contained in the
public agency's application, the FAA has determined that the approved
class accounts for less than 1 percent of the total annual enplanements
at Tulsa International Airport.
    Brief Description of Projects Approved for Collection and Use:

Concourse A rehabilitation.
Terminal building chillers.
PFC consulting services.

    Decision Date: October 22, 2013.

FOR FURTHER INFORMATION CONTACT: Don Harris, Arkansas/Oklahoma Airports
Development Office,<PHONE_NUMBER>.

                                           Amendments to PFC Approvals
----------------------------------------------------------------------------------------------------------------
                                                                                Original         Amended
                                     Amendment       Original         Amended        estimated       estimated
   Amendment No., city, state      approved date   approved net    approved net     charge exp.     charge exp.
                                                    PFC revenue     PFC revenue        date            date
----------------------------------------------------------------------------------------------------------------
06-07-C-01-HDN, Hayden, CO......        09/24/13      $2,199,678      $2,021,503        12/01/11        04/01/12
99-03-C-03-BOI, Boise, ID.......        09/27/13      96,884,411      84,362,062        08/01/18        05/01/16
07-08-C-02-PHX, Phoenix, AZ.....        09/30/13     187,649,602     179,036,442        08/01/10        08/01/10
01-01-C-01-OXR, Oxnard, CA......        09/30/13         872,000         631,115        03/01/11        03/01/11
07-03-C-02-CEC, Crescent City,          09/30/13         301,745         283,357        07/01/13        07/01/13
 CA.............................
07-03-C-01-RDD, Redding, CA.....        09/30/13         809,295         670,755        09/01/11        09/01/11
08-04-C-01-STS, Santa Rosa, CA..        09/30/13       1,594,049       1,319,049        04/01/13        04/01/13
07-05-C-02-PIH, Pocatello, ID...        10/15/13         419,295         240,192        02/01/10        12/01/08
94-01-C-07-ISP, Ronkonkoma, NY..        10/16/13      22,382,626      22,305,857        07/01/04        07/01/04
96-02-C-02-ISP, Ronkonkoma, NY..        10/16/13       4,497,958       4,496,961        03/01/05        03/01/05
06-06-C-03-LBB, Lubbock, TX.....        10/23/13      12,451,441      12,419,871        12/01/13        11/01/12
10-07-C-01-LBB, Lubbock, TX.....        10/23/13      13,101,351       7,164,045        07/01/19        09/01/16
----------------------------------------------------------------------------------------------------------------

    Issued in Washington, DC, on December 30, 2013.
Joe Hebert,
Manager, Financial Analysis and Passenger Facility Charge Branch.
[FR Doc. 2013-31553 Filed 1-3-14; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 77, Number 143 (Wednesday, July 25, 2012)]
[Notices]
[Pages 43600-43601]
[FR Doc No: 2012-18095]

=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0001]

Cardiovascular and Renal Drugs Advisory Committee; Notice of
Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

    This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will
be open to the public.
    Name of Committee: Cardiovascular and Renal Drugs Advisory
Committee.
    General Function of the Committee: To provide advice and
recommendations to the Agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on September 13, 2012, from
8 a.m. to 5 p.m.
    Location: FDA White Oak Campus, Building 31, the Great Room, White
Oak Conference Center (rm. 1503), 10903 New Hampshire Ave., Silver
Spring, MD 20993-0002. Information regarding special accommodations due
to a disability, visitor parking, and transportation may be accessed
at: http://www.fda.gov/AdvisoryCommittees/default.htm; under the
heading ``Resources for You,'' click on ``Public Meetings at the FDA
White Oak Campus.'' Please note that visitors to the White Oak Campus
must enter through Building 1.
    Contact Person: Kalyani Bhatt, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Avenue,
WO31-2417, Silver Spring, MD 20993-0002,<PHONE_NUMBER>, FAX: 301-847-
8533, email<EMAIL_ADDRESS>or FDA Advisory Committee Information
Line, 1-800-741-8138<PHONE_NUMBER> in the Washington, DC area), to find
out information regarding FDA advisory committee information. A notice
in the Federal Register about last minute modifications that impact a
previously announced advisory committee meeting cannot always be
published quickly enough to provide timely notice. Therefore, you
should always check the Agency's Web site at http://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate
advisory committee link, or call the advisory committee information
line to learn about possible modifications before coming to the
meeting.
    Agenda: During the morning session, the committee will discuss new
drug application (NDA) 203009, lixivaptan, submitted by Cardiokine
Biopharma, LLC, for the proposed indication of the treatment of
symptomatic hypervolemic and euvolemic hyponatremia associated with
heart failure and syndrome of inappropriate antidiuretic hormone
(SIADH), respectively.
    During the afternoon session, the committee will discuss NDA
203826, phenylephrine hydrochloride injection, USP, submitted by West-
Ward Pharmaceutical Corp., to increase blood pressure in acute
hypotensive states, such as shock and peri-operative hypotension.
    FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its Web site prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's Web site after the meeting. Background material is
available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee link.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person on or before
August 29, 2012. Oral presentations from the public will be scheduled
between approximately 10:30 a.m. to 11 a.m., and 3:30 p.m. to 4 p.m.
Those individuals interested in making formal oral presentations should
notify the contact person and submit a brief statement of the general
nature of the evidence or arguments they wish to present, the names and
addresses of proposed participants, and an indication of the
approximate time requested to make their presentation on or before
August 21, 2012. Time allotted for each presentation may be limited. If

the number of registrants requesting to speak is greater than can be
reasonably accommodated during the scheduled open public hearing
session, FDA may conduct a lottery to determine the speakers for the
scheduled open public hearing session. The contact person will notify
interested persons regarding their request to speak by August 22, 2012.
    Persons attending FDA's advisory committee meetings are advised
that the Agency is not responsible for providing access to electrical
outlets.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
physical disabilities or special needs. If you require special
accommodations due to a disability, please contact Kalyani Bhatt at
least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: July 19, 2012.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2012-18095 Filed 7-24-12; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 88, Number 52 (Friday, March 17, 2023)]
[Notices]
[Pages 16429-16431]
[FR Doc No: 2023-05425]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #1

    Take notice that the Commission received the following exempt
wholesale generator filings:

    Docket Numbers: EG23-88-000.
    Applicants: Fifth Standard Solar PV, LLC.
    Description: Fifth Standard Solar PV, LLC submits Notice of Self-
Certification of Exempt Wholesale Generator Status.
    Filed Date: 3/10/23.
    Accession Number: 20230310-5173.
    Comment Date: 5 p.m. ET 3/31/23.

    Take notice that the Commission received the following Complaints
and Compliance filings in EL Dockets:

    Docket Numbers: EL23-45-000.
    Applicants: Public Service Commission of West Virginia v. PJM
Interconnection, L.L.C.
    Description: Complaint of Public Service Commission of West
Virginia v. PJM Interconnection, L.L.C.
    Filed Date: 3/8/23.
    Accession Number: 20230308-5167.
    Comment Date: 5 p.m. ET 3/28/23.

    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER10-2126-006; EL23-9-000.
    Applicants: Idaho Power Company.
    Description: Response to February 15, 2023, Deficiency Letter of
Idaho Power Company.
    Filed Date: 3/7/23.
    Accession Number: 20230307-5185.
    Comment Date: 5 p.m. ET 3/28/23.

    Docket Numbers: ER22-290-003.
    Applicants: Oakland Power Company LLC.
    Description: Compliance filing: Notice of Implementation of Capital
Items to be effective 9/1/2022.
    Filed Date: 3/10/23.
    Accession Number: 20230310-5169.
    Comment Date: 5 p.m. ET 3/31/23.

    Docket Numbers: ER23-892-001.
    Applicants: PJM Interconnection, L.L.C.
    Description: Tariff Amendment: Amendment to Enhancements in OATT
Att. Q and Request Shortened Comment Period to be effective 4/6/2023.
    Filed Date: 3/10/23.
    Accession Number: 20230310-5193.
    Comment Date: 5 p.m. ET 3/15/23.

    Docket Numbers: ER23-926-000.
    Applicants: LS Power Grid California, LLC.
    Description: LS Power Grid California, LLC submits Supplemental
Information re HVDC Projects under ER23-926.
    Filed Date: 3/9/23.
    Accession Number: 20230309-5222.
    Comment Date: 5 p.m. ET 3/20/23.

    Docket Numbers: ER23-1279-000.
    Applicants: DTE Energy Services, Inc.
    Description: Baseline eTariff Filing: DTE Energy Services MBR
Application Filing to be effective 3/10/2023.
    Filed Date: 3/9/23.
    Accession Number: 20230309-5146.
    Comment Date: 5 p.m. ET 3/30/23.

    Docket Numbers: ER23-1281-000.
    Applicants: Midcontinent Independent System Operator, Inc.
    Description: Sec.  205(d) Rate Filing: 2023-03-10_SA 3314 Entergy
Louisiana-St. James Solar 1st Rev GIA (J1142) to be effective 3/2/2023.
    Filed Date: 3/10/23.
    Accession Number: 20230310-5009.
    Comment Date: 5 p.m. ET 3/31/23.

    Docket Numbers: ER23-1284-000.
    Applicants: ITC Midwest LLC.
    Description: Sec.  205(d) Rate Filing: Filing of an Amended and
Restated Interconnection Agreement to be effective 5/10/2023.
    Filed Date: 3/10/23.
    Accession Number: 20230310-5013.
    Comment Date: 5 p.m. ET 3/31/23.

    Docket Numbers: ER23-1285-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: Amended WMPA, Service
Agreement No. 4840; Queue No. AC2-174 to be effective 5/10/2023.
    Filed Date: 3/10/23.
    Accession Number: 20230310-5025.
    Comment Date: 5 p.m. ET 3/31/23.

    Docket Numbers: ER23-1286-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: Amendment to ISA, Service
Agreement No. 6664; Queue No. AF1-083 to be effective 5/9/2023.
    Filed Date: 3/10/23.
    Accession Number: 20230310-5027.
    Comment Date: 5 p.m. ET 3/31/23.

    Docket Numbers: ER23-1290-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: Amendment to ISA, Service
Agreement No. 6657; Queue No. AF1-050 to be effective 5/9/2023.
    Filed Date: 3/10/23.
    Accession Number: 20230310-5031.
    Comment Date: 5 p.m. ET 3/31/23.

    Docket Numbers: ER23-1291-000.
    Applicants: Ashtabula Wind III, LLC.
    Description: Tariff Amendment: Ashtabula Wind III, LLC Notice of
Cancellation of Market-Based Rate Tariff to be effective 3/11/2023.
    Filed Date: 3/10/23.
    Accession Number: 20230310-5050.
    Comment Date: 5 p.m. ET 3/31/23.

    Docket Numbers: ER23-1292-000.
    Applicants: PacifiCorp.
    Description: Tariff Amendment: Termination of Avangrid Const Agmt
for Klamath Metering to be effective 5/25/2023.
    Filed Date: 3/10/23.
    Accession Number: 20230310-5054.
    Comment Date: 5 p.m. ET 3/31/23.

    Docket Numbers: ER23-1297-000.
    Applicants: Midcontinent Independent System Operator, Inc.,
Michigan Electric Transmission Company, LLC.
    Description: Sec.  205(d) Rate Filing: Midcontinent Independent
System Operator, Inc. submits tariff filing per 35.13(a)(2)(iii: 2023-
03-10_SA 1926 METC-CE 9th Rev DTIA to be effective 3/1/2023.
    Filed Date: 3/10/23.
    Accession Number: 20230310-5073.
    Comment Date: 5 p.m. ET 3/31/23.

    Docket Numbers: ER23-1298-000.
    Applicants: OnPoint Energy Illinois, LLC.
    Description: Tariff Amendment: Notice of Cancellation and Request
for Waiver to be effective 3/11/2023.
    Filed Date: 3/10/23.
    Accession Number: 20230310-5079.
    Comment Date: 5 p.m. ET 3/31/23.

    Docket Numbers: ER23-1299-000.
    Applicants: OnPoint Energy Northeast, LLC.
    Description: Compliance filing: Notice of Succession and Revised
Market-Based Rate Tariff to be effective 3/11/2023.
    Filed Date: 3/10/23.
    Accession Number: 20230310-5080.
    Comment Date: 5 p.m. ET 3/31/23.

    Docket Numbers: ER23-1300-000.
    Applicants: OnPoint Energy Ohio, LLC.
    Description: Tariff Amendment: Notice of Cancellation and Request
for Waiver to be effective 3/11/2023.
    Filed Date: 3/10/23.
    Accession Number: 20230310-5082.
    Comment Date: 5 p.m. ET 3/31/23.

    Docket Numbers: ER23-1302-000.
    Applicants: Alabama Power Company, Georgia Power Company,
Mississippi Power Company.
    Description: Tariff Amendment: Alabama Power Company submits tariff
filing per 35.15: RE Limestone LGIA Termination Filing to be effective
3/10/2023.
    Filed Date: 3/10/23.
    Accession Number: 20230310-5084.
    Comment Date: 5 p.m. ET 3/31/23.

    Docket Numbers: ER23-1304-000.
    Applicants: MFT Energy US 1 LLC.
    Description: Baseline eTariff Filing: Baseline new to be effective
3/13/2023.
    Filed Date: 3/10/23.
    Accession Number: 20230310-5085.
    Comment Date: 5 p.m. ET 3/31/23.

    Docket Numbers: ER23-1307-000.
    Applicants: New York Independent System Operator, Inc.
    Description: Sec.  205(d) Rate Filing: NYISO 205 filing re: Virtual
and External Transactions to be effective 12/31/9998.
    Filed Date: 3/10/23.
    Accession Number: 20230310-5118.
    Comment Date: 5 p.m. ET 3/31/23.

    Docket Numbers: ER23-1308-000.
    Applicants: Midcontinent Independent System Operator, Inc.
    Description: Sec.  205(d) Rate Filing: 2023-03-10_SA 4005 Ameren
Missouri-Northeast Missouri Wind FSA (MPFCA) (J1025) to be effective 5/
10/2023.
    Filed Date: 3/10/23.
    Accession Number: 20230310-5128.
    Comment Date: 5 p.m. ET 3/31/23.

    Docket Numbers: ER23-1314-000.
    Applicants: ITC Midwest LLC.
    Description: Sec.  205(d) Rate Filing: Joint Use Pole Agreement
with Amana Society Service Company (RS No. 223) to be effective 5/10/
2023.
    Filed Date: 3/10/23.
    Accession Number: 20230310-5156.
    Comment Date: 5 p.m. ET 3/31/23.

    Docket Numbers: ER23-1315-000.
    Applicants: Northern Indiana Public Service Company LLC.
    Description: Sec.  205(d) Rate Filing: Lagrange TDSIC CIAC to be
effective 6/1/2023.
    Filed Date: 3/10/23.
    Accession Number: 20230310-5175.
    Comment Date: 5 p.m. ET 3/31/23.

    The filings are accessible in the Commission's eLibrary system
(https://elibrary.ferc.gov/idmws/search/fercgensearch.asp) by querying
the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: March 10, 2023.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2023-05425 Filed 3-16-23; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: July 15, 2010 (Volume 75, Number 135)]
[Notices]
[Page 41258-41262]
[DOCID:fr15jy10-108]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-62468; File No. SR-NASDAQ-2010-074]

Self-Regulatory Organizations; The NASDAQ Stock Market LLC;
Notice of Filing of a Proposed Rule Change, as Modified by Amendment
No. 1, To Adopt Rule 4753(c) as a Six Month Pilot in 100 NASDAQ-Listed
Securities

July 7, 2010.
    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 June 18, 2010, The NASDAQ Stock Market LLC (``Nasdaq'' or the
``Exchange'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I, II,
and III below, which Items have been prepared by Nasdaq. On June 25,
2010, Nasdaq filed Amendment No. 1 to the proposed rule change. The
Commission is publishing this notice to solicit comments on the
proposed rule change, as amended, 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

    NASDAQ is proposing to adopt Rule 4753(c) as an initial six month
pilot in 100 NASDAQ-listed securities.
    The text of the proposed rule change is below. Proposed new
language is in italics; proposed deletions are in brackets.\3\
---------------------------------------------------------------------------

    \3\ Changes are marked to the rule text that appears in the
electronic manual of NASDAQ found at http://
nasdaq.cchwallstreet.com.
---------------------------------------------------------------------------

* * * * *
4753. Nasdaq Halt and Imbalance Crosses
    (a)-(b) No change.
    (c) Beginning August 1, 2010, for a period of six months,
[B]between 9:30 a.m. and 4 p.m. EST, the System will

automatically monitor System executions to determine whether the market
is trading in an orderly fashion and whether to conduct an Imbalance
Cross in order to restore an orderly market in a single Nasdaq
Security.
    (1) An Imbalance Cross shall occur if the System executes a
transaction in a Nasdaq Security at a price that is beyond the
Threshold Range away from the Triggering Price for that security. The
Triggering Price for each Nasdaq Security shall be the price of any
execution by the System in that security within the prior 30 seconds.
The Threshold Range shall be determined as follows:

------------------------------------------------------------------------
                                                           Thresh[h]old
                                                            range away
                                                               from
                     Execution price                        triggering
                                                               price
                                                             (percent)
------------------------------------------------------------------------
$1.75 and under.........................................              15
Over $1.75 and up to $25................................              10
Over $25 and up to $50..................................               5
Over $50................................................               3
------------------------------------------------------------------------

     (2) If the System determines pursuant to subsection (1) above to
conduct an Imbalance Cross in a Nasdaq Security, the System shall
automatically cease executing trades in that security for a 60-second
Display Only Period. During that 60-second Display Only Period, the
System shall:
    (A) Maintain all current quotes and orders and continue to accept
quotes and orders in that System Security; and
    (B) Disseminate by electronic means an Order Imbalance Indicator
every 5 seconds.
    (3) At the conclusion of the 60-second Display Only Period, the
System shall re-open the market by executing the Nasdaq Halt Cross as
set forth in subsection (b)(2)-(4) above.
    (4) No change.
* * * * *

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

    In its filing with the Commission, NASDAQ included statements
concerning the purpose of, and basis for, the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below, and is set forth in Sections A, B, and C below.

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

1. Purpose
    NASDAQ is proposing to adopt Rule 4753(c), a volatility-based pause
in trading in individual NASDAQ-listed securities traded on NASDAQ
(``NASDAQ Securities''). NASDAQ is proposing to adopt the rule
initially as a six-month pilot in 100 NASDAQ Securities beginning
August 1, 2010.
Background
    NASDAQ's efficient market structure allows the price of a security
to change quickly in response to information and market demand.
Allowing trading to react quickly is generally beneficial to investors.
In some circumstances, however, abrupt and significant movements in the
price at which a security is traded can indicate aberrant volatility,
which is harmful to investors. On August 19, 2008, the Commission
approved new Rule 4753(c), which established a volatility-based halt
process on a one-year pilot basis for an initial 100 NASDAQ-listed
securities.\4\ Subsequent to the Commission's approval, NASDAQ
implemented a market order price collar to address aberrant volatility
in lieu of immediately implementing the Rule 4753(c) pilot.\5\ Although
these collars are designed to address volatility by reducing the risk
that market orders will execute at prices that are significantly worse
than the national best bid and offer, they had limited effect on May 6,
2010 because of the limited number of market orders involved in trading
that day on NASDAQ.
---------------------------------------------------------------------------

    \4\ Securities Exchange Act Release No. 58386 (August 19, 2008),
73 FR 50380 (August 26, 2008) (SR-NASDAQ-2007-067).
    \5\ This process cancels any portion of most unpriced orders
that would execute either on NASDAQ or when routed to another market
center at a price that is the greater of $0.25 or 5 percent worse
than the NBBO at the time NASDAQ receives the order. See Securities
Exchange Act Release No. 60371 (July 23, 2009), 74 FR 38075 (July
30, 2009) (SR-NASDAQ-2009-070).
---------------------------------------------------------------------------

    In light of the unprecedented aberrant volatility witnessed on May
6, 2010, and the limited effect that NASDAQ's market collars had in
dampening such volatility, NASDAQ believes that the Rule 4753(c) halt
process is needed to protect its listed securities and market
participants from such volatility in the future. Accordingly, as
described below, NASDAQ is proposing to adopt Rule 4753(c) again as a
six-month pilot for 100 NASDAQ-listed securities.
NASDAQ's Approach: Rule 4753(c)
    NASDAQ originally adopted Rule 4753(c) to promote the protection of
investors by providing a meaningful pause in NASDAQ Securities on
NASDAQ in the midst of abrupt and significant price movements, while
permitting trading to move freely in rapid and stable markets.\6\ As
the events of May 6, 2010 show, severe and rapid price dislocation can
occur in securities with no connection to the fundamental soundness of
the underlying companies. Such dislocation may be caused by operational
and structural factors beyond the control of issuers and individual
markets. NASDAQ's Rule 4753(c) process is designed to protect NASDAQ
securities and market participants from aberrant volatility, which can
quickly spread like a contagion from market to market, to allow time to
reestablish a rational market in NASDAQ Securities.
---------------------------------------------------------------------------

    \6\ NASDAQ has other similar processes that serve to protect
investors during periods of abnormal trading activity. NASDAQ Rule
4120 authorizes NASDAQ Regulation to halt trading in a security
based upon news or an emergency in the market. NASDAQ Regulation
also has the ability under NASDAQ Rule 11890 to break trades in
order to protect the integrity of the market.
---------------------------------------------------------------------------

    NASDAQ's proposed Rule 4753(c) process automatically suspends
trading in individual NASDAQ Securities that are the subject of abrupt
and significant intraday price movements between 9:30 a.m. and 4 p.m.
Eastern Standard Time. The Rule 4753(c) process is triggered
automatically when the execution price of a NASDAQ Security moves more
than a fixed amount away from a pre-established ``triggering price''
for that security. The Triggering Price for each NASDAQ Security is the
price of any execution by the System \7\ in that security within the
previous 30 seconds. For each NASDAQ Security, the System continually
compares the price of each execution in the System against the prices
of all System executions in that security over the 30 seconds.
---------------------------------------------------------------------------

    \7\ As defined in Rule 4751(a).
---------------------------------------------------------------------------

    Proposed Rule 4753(c) has tiered triggering price range percentages
that are based on the execution price of a security. NASDAQ has
observed that, on a percentage basis, lower priced stocks normally
trade in a wider range than stocks with higher prices. For example,
during the first quarter of 2010, a period of relatively low market
volatility, stocks priced under $1.75 had an average range (percent
difference from high to low over the course of the day) of 9%, stocks
priced $1.75 up to $24.99 had an average range of 4%. Stocks priced $25
to $49.99 had an average range of 3%. Stocks priced above $50

had an average range of 2%. The purpose of Rule 4753(c) is not to
inhibit trading within the normal range, but rather to pause trading in
instances of aberrant volatility. As a consequence, NASDAQ selected
percentage tiers that allow for a wider range in lower priced
securities, with decreasing ranges on a percentage basis as price
increases.
    When the Rule 4753(c) process is triggered, NASDAQ institutes a
formal trading halt during which time NASDAQ systems are prohibited
from executing orders.\8\ Members, however, may continue to enter
quotes and orders, which are queued during a 60-second Display Only
Period. At the conclusion of the Display Only Period, the queued orders
are executed at a single price, pursuant to Rule 4753.
---------------------------------------------------------------------------

    \8\ A halt pursuant to Rule 4753(c) is not considered a
regulatory halt and, therefore, it does not trigger a market-wide
trading halt under Section X of the NASDAQ UTP Plan. As a result,
other markets are permitted to continue trading a NASDAQ stock that
is undergoing a Market Re-Opening on NASDAQ. During the Rule 4753(c)
process, NASDAQ's quotations are marked ``closed,'' signaling to
other markets that quotes and orders routed to NASDAQ will not be
executed. A Rule 4753(c) trade is reported to the network processor
as a single-price re-opening that is exempt from trade through
restrictions pursuant to Rule 611(b)(3).
---------------------------------------------------------------------------

Current Environment
    In light of the events of May 6, 2010, NASDAQ believes that
circumstances warrant the implementation of Rule 4753(c), in addition
to the market collar protections currently in place.\9\ NASDAQ believes
that implementing Rule 4753(c) will serve to protect market
participants from aberrant volatility such as that which occurred on
May 6, 2010. NASDAQ also believes that Rule 4753(c) will serve as a
complement to the recently-approved cross-market single stock pause to
be adopted by the U.S. national securities exchanges.\10\ NASDAQ notes
that there are several differences between the cross-market approach
and Rule 4753(c). Specifically, Rule 4753(c) uses tiered threshold
range percentages that are based on a security's execution price in
determining the price at which a halt would be initiated, whereas the
cross market approach does not. Rule 4753(c) also has a shorter time
threshold used in determining that a pause in trading should be
initiated, and a shorter time during which a security is paused, as
compared to the cross-market approach. Rule 4753(c) is applied
throughout the trading day, whereas the cross-market approach does
[sic] not. Last, while the cross-market approach will help to prevent
aberrant volatility, it applies only to S&P 500 Index securities, thus
it will not address aberrant volatility in the majority of NASDAQ-
listed securities. Adoption of Rule 4753(c) will allow NASDAQ to extend
the rule's protections to its listed securities trading on NASDAQ, with
such protections initially applying to the 100 pilot securities \11\
but with the goal of applying the rule to all NASDAQ-listed securities.
---------------------------------------------------------------------------

    \9\ NASDAQ notes that, while the market collar protections were
in place during the events of May 6, 2010, only approximately five
percent of the volume on NASDAQ was attributable to market orders.
    \10\ Securities Exchange Act Release No. 62252 (June 10, 2010),
75 FR 34186 (June 16, 2010) (SR-BATS-2010-014; SR-EDGA-2010-01; SR-
EDGX-2010-01; SR-BX-2010-037; SR-ISE-2010-48; SR-NYSE-2010-39; SR-
NYSEAmex-2010-46; SR-NYSEArca-2010-41; SR-NASDAQ-2010-061; SR-CHX-
2010-10; SR-NSX-2010-05; SR-CBOE-2010-047).
    \11\ Amendment No. 1 indicates that the pilot securities will be
the NASDAQ 100 securities.
---------------------------------------------------------------------------

    The following examples illustrate how Rule 4753(c) would operate in
relation to the new cross-market single stock pause. In this sequence
of events, the Rule 4753(c) pause is triggered prior to the cross-
market trading pause process:
    WXYZ is NASDAQ-listed and included in the S&P 500 Index.

 2:00:00 p.m., WXYZ trades at $300 on NASDAQ, which is also the
consolidated last sale price
[cir] 2:00:30 p.m., WXYZ trades below $291 on NASDAQ
    [cir] WXYZ is paused pursuant to Rule 4753(c)
    [cir] WXYZ continues to trade elsewhere
 2:01:30 p.m., WXYZ resumes trading on NASDAQ at $295
 2:02:00 p.m., WXYZ trades below 286.15 on NASDAQ
    [cir] WXYZ is again paused pursuant to Rule 4753(c)
    [cir] WXYZ continues to trade elsewhere
 2:03:00 p.m., WXYZ resumes trading on NASDAQ at $288;
 2:03:30 p.m., WXYZ trades below 279.36 on NASDAQ;
    [cir] WXYZ is again paused pursuant to Rule 4753(c)
    [cir] WXYZ continues to trade elsewhere
 2:04:00 p.m., WXYZ consolidated last sale price reaches $270
    [cir] The cross-market trading pause process is triggered
    [cir] NASDAQ abandons the Rule 4753(c) and now follows the cross-
market trading pause process

    The following sequence of events illustrates a situation whereby a
NASDAQ-listed security that is also covered by the cross-market trading
pause process triggers both processes simultaneously:
    WXYZ is NASDAQ-listed and included in the S&P 500 Index.

 2:00:00 p.m., WXYZ trades at $20 on NASDAQ, which is also the
consolidated last sale price;
 2:00:30 p.m., WXYZ trades at $17 on NASDAQ;
    [cir] Because the execution price exceeds both the 10 percent tiers
of the cross-market pause process and Rule 4753(c), the cross-market
process is followed
    [cir] WXYZ is paused on all markets

    The following sequence of events illustrates a situation whereby a
NASDAQ-listed security may fall greater than 15 percent, yet does not
trigger the cross-market trading pause process:
    WXYZ is NASDAQ-listed, but not included in the S&P 500 Index.
 2:00:00 p.m., WXYZ trades at $1.50 on NASDAQ, which is also
the consolidated last sale price;
 2:00:30 p.m., WXYZ trades below $1.275 on NASDAQ;
    [cir] Although the security dropped more than 10 percent, the
cross-market trading pause process would not triggered, since the
security is not included in the S&P 500 Index
    [cir] WXYZ is paused pursuant to Rule 4753(c) because the security
dropped greater than 15 percent in the prior 30 seconds
    [cir] WXYZ continues to trade elsewhere
    The examples above show that, although Rule 4753(c) operates
independently from the cross-market trading pause process, both trade
pause processes work efficiently along side of each other to dampen
aberrant volatility.
Other Market's Approach
    NASDAQ notes that another market has adopted a similar process
whereby the market's listed securities each may be temporarily removed
from automatic trading when the trading exceeds certain average daily
volume-, price-, and volatility-based criteria.\12\ Although dissimilar
in process due to the differing nature of the markets, the pause under
Rule 4753(c) is designed to achieve the same goal, namely, to apply
quantitative criteria to pause trading in a listed security during
times of aberrant volatility so that a more representative market may
develop. NASDAQ's process differs from the other market's process in
that it uses completely transparent criteria and timeframes, which
serve to eliminate uncertainty from the trade pause process. For
example and as noted above, the Rule 4753(c) process is triggered by
execution prices that are clear and available to all market
participants, and the pause in trading has a fixed 60 second Display

Only period process that cannot be extended.\13\ In addition, the pause
will be followed by a ``cross'' that is predictable and well defined.
As a consequence, application of the Rule 4753(c) process is automatic
and precise, allowing no place for uncertainty. This will make the
transition to this rule predictable and understandable. Most
importantly, it will allow NASDAQ to insulate its issuers from
volatility injected in the market from exchange halt programs with
subjective criteria. Primary markets with responsibility to listed
companies have an obligation and right to take actions to provide
additional levels of protection from volatility to companies that list
with it [sic].
---------------------------------------------------------------------------

    \12\ NYSE Rule 1000(a)(iv).
    \13\ NYSE's LRP process has an indeterminate length, but can
last several minutes during which the NYSE is not transmitting a
protected quote in the affected security.
---------------------------------------------------------------------------

Summary
    In approving Rule 4753(c), the Commission stated that
systematically suspending trading in NASDAQ-listed securities that are
the subject of abrupt and significant intra-day price movements
promotes fair and orderly markets and the protection of investors.\14\
NASDAQ believes that adopting Rule 4753(c) is more appropriate now than
it was at the time the Commission originally approved Rule 4753(c)
given the need to protect investors from aberrant volatility, such as
the volatility witnessed on May 6, 2010. Accordingly, NASDAQ is
proposing to adopt Rule 4753(c) in identical form as originally
approved by the Commission, but as a six month pilot for an initial 100
Nasdaq-listed securities. During this pilot period, NASDAQ will study
the impact of the rule on the pilot securities and will provide the
Commission with monthly reports detailing its ongoing review of the
pilot. These reports will inform the Commission of the number of times
Rule 4753(c) is triggered and the security or securities involved, and
will describe any patterns that emerge during the pilot period. NASDAQ
is also making a technical correction to the table found in Rule
4753(c)(1).
---------------------------------------------------------------------------

    \14\ Supra note 4 at 50381.
---------------------------------------------------------------------------

2. Statutory Basis
    NASDAQ believes the proposed rule change is consistent with the
provisions of Section 6 of the Act,\15\ in general and with Section
6(b)(5) of the Act,\16\ in particular, which requires that the rules of
an exchange be designed to prevent fraudulent and manipulative acts and
practices, promote just and equitable principles of trade, foster
cooperation and coordination with persons engaged in regulating,
clearing, settling, processing information with respect to, and
facilitating transactions in securities, remove impediments to and
perfect the mechanism of a free and open market and a national market
system, and, in general, protect investors and the public interest. The
proposed rule change is consistent with these requirements in that it
will reduce the negative impacts of sudden, unanticipated volatility in
individual NASDAQ Securities, and serve to restore an orderly market in
a transparent and uniform manner, enhance the price-discovery process,
increase overall market confidence, and promote fair and orderly
markets and the protection of investors.
---------------------------------------------------------------------------

    \15\ 15 U.S.C. 78f.
    \16\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    NASDAQ notes that the proposed rule change is identical to the rule
change approved by the Commission when it approved Rule 4753(c) in
August 2008, except that NASDAQ plans to implement the pilot on a
shorter, six month basis. In approving Rule 4753(c), the Commission
acknowledged that Rule 4753(c), which systematically suspends trading
in NASDAQ-listed securities that are the subject of abrupt and
significant intra-day price movements, promotes fair and orderly
markets and the protection of investors.\17\ NASDAQ notes that the
Commission received no comments on the proposed rule change that
adopted Rule 4753(c) originally. NASDAQ believes that the lack of
comment signaled that market participants considered the proposed new
rule to be non-controversial. NASDAQ believes that, given the events of
May 6, 2010, adopting Rule 4753(c) as a new pilot will ensure that
covered NASDAQ Securities, and market participants trading therein on
NASDAQ, are provided the needed protections of the rule.
---------------------------------------------------------------------------

    \17\ Supra note 4 at 50381.
---------------------------------------------------------------------------

    NASDAQ notes that the proposed rule change supplements the cross-
market single stock pause to be adopted by the national securities
exchanges, which was approved by the Commission on June 10, 2010.\18\
NASDAQ applauds the Commission's leadership in bringing the national
securities exchanges together to achieve a cross-market solution to
help address the issues that may have caused the events of May 6, 2010.
NASDAQ is continuously assessing actions it can take to further
strengthen its market. In this regard, NASDAQ believes that quickly
implementing Rule 4753(c) will complement the cross-market single stock
pause by serving to better protect all of NASDAQ's listed securities
covered by the pilot trading on NASDAQ during times of aberrant
volatility, such as the volatility witnessed on May 6, 2010. NASDAQ
notes that Rule 4753(c) in no way conflicts with the new cross-market
single stock pause, but rather applies, in some cases, more stringent
criteria to pause a broader range of securities on NASDAQ only. In
addition, should a cross-market single stock pause be initiated in a
NASDAQ Security during a Rule 4753(c) pause, the security would be
subject to the cross-market single stock pause process.
---------------------------------------------------------------------------

    \18\ Supra note 10.
---------------------------------------------------------------------------

    NASDAQ has an obligation to adopt rules that protect investors and
the public interest, which include rules that protect its listed
securities and those that trade in them. Instituting Rule 4753(c) will
serve to protect market participants within the scope of NASDAQ's
authority under the Act. NASDAQ notes that market participants would be
able to trade in securities subject to a Rule 4753(c) pause at other
market venues, should they so choose.\19\
---------------------------------------------------------------------------

    \19\ Supra note 8.
---------------------------------------------------------------------------

    Last, NASDAQ notes that, in approving another market's approach to
dealing with abnormal volatility in its listed securities, the
Commission stated that precluding automatic executions under certain
circumstances is warranted.\20\ Like that market's process, the
proposed change to NASDAQ Rule 4753(c) will extend the rule's halt
process to all listed securities traded on NASDAQ and will likewise
serve to dampen volatility, thus providing market participants with
time to react to achieve a more natural trading pattern of a particular
security.
---------------------------------------------------------------------------

    \20\ Securities Exchange Act Release No. 53539 (March 22, 2006),
71 FR 16353, 16377-78 (March 31, 2006) (SR-NYSE-2004-05).
---------------------------------------------------------------------------

    NASDAQ will keep the Commission apprised of the use of Rule 4753(c)
as part of NASDAQ's ongoing review of the pilot. In this regard, during
the pilot period NASDAQ will provide the Commission with monthly
reports detailing the use of Rule 4753(c) and describing any patterns
that may develop. As such, NASDAQ believes that the proposed rule
change is consistent with the protection of investors and the public
interest, and does not raise any novel regulatory issues.

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

    NASDAQ 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, as amended.

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

    Within 35 days of the date of publication of this notice in the
Federal Register or within such longer period (i) as the Commission may
designate up to 90 days of such date if it finds such longer period to
be appropriate and publishes its reasons for so finding or (ii) as to
which the self-regulatory organization consents, the Commission will:
    (A) By order approve such proposed rule change, or
    (B) Institute proceedings to determine whether the proposed rule
change should be disapproved.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning all aspects of the foregoing, including whether
the proposed rule change is consistent with the Act. A stated purpose
of the proposal is to protect Nasdaq-listed securities and market
participants from ``aberrant'' volatility, such as that which occurred
on May 6, 2010 and may be caused by operational or structural factors
beyond the control of issuers and individual markets. To what extent do
the price changes that would trigger a trading halt under the proposal
indicate the potential existence of ``aberrant'' volatility, as opposed
to the normal operation of the markets? If these price changes indicate
potentially ``aberrant'' volatility, to what extent will the proposal
address such volatility in a manner appropriate and consistent with the
purposes of the Act? Will a trading halt at Nasdaq under the proposal
restrict liquidity or increase volatility in the affected stock, since
other markets can continue to trade the stock and may not have
comparable volatility halts? In what respects are the consequences of
this proposal likely to be similar to, or different from, the effects
of other exchange-specific mechanisms that currently restrict trading
on the relevant exchange under certain circumstances? More generally,
to what extent is it appropriate for different exchanges to adopt
different and potentially inconsistent approaches to trading pauses or
restrictions that might affect the same stock? To what extent does the
answer change based on whether the affected stock is already subject to
a market-wide single-stock circuit breaker that applies consistently
across all trading venues?
    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 e-mail to<EMAIL_ADDRESS>Please include
File Number SR-Nasdaq-2010-074 on the subject line.

Paper Comments

     Send paper comments in triplicate to Elizabeth M. Murphy,
Secretary, Securities and Exchange Commission, Station Place, 100 F
Street, NE., Washington, DC 20549-1090.

All submissions should refer to File Number SR-Nasdaq-2010-074. This
file number should be included on the subject line if e-mail 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 a.m. and 3 p.m. Copies of such filing also will be
available for inspection and copying at the principal office of Nasdaq.
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 publicly
available. All submissions should refer to File Number SR-Nasdaq-2010-
074 and should be submitted on or before August 5, 2010.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\21\
---------------------------------------------------------------------------

    \21\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Florence E. Harmon,
Deputy Secretary.
[FR Doc. 2010-17191 Filed 7-14-10; 8:45 am]
BILLING CODE 8010-01-P


[Federal Register Volume 77, Number 129 (Thursday, July 5, 2012)]
[Notices]
[Pages 39760-39761]
[FR Doc No: 2012-16371]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-67289; File No. SR-ICC-2012-04]

Self-Regulatory Organizations; ICE Clear Credit LLC; Order
Approving Proposed Rule Change To Add Rules Related to the Clearing of
Emerging Markets Sovereign Index CDS

June 28, 2012.

I. Introduction

    On April 3, 2012, ICE Clear Credit LLC (``ICC'') filed with the
Securities and Exchange Commission (``Commission'') the proposed rule
change (SR-ICC-2012-04) pursuant to Section 19(b)(1) of the Securities
Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4 thereunder.\2\ The
proposed rule change was published for comment in the Federal Register
on April 16, 2012.\3\ On May 29, 2012, the Commission extended the time
within which to take action of the proposed rule change to July 13,
2012.\4\ The Commission received no comment letters regarding the
proposal. For the reasons discussed

below, the Commission is granting approval of the proposed rule change.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ Securities Exchange Act Release No. 66777 (April 10, 2012),
77 FR 22623 (April 16, 2012).
    \4\ Securities Exchange Act Release No. 67070 (May 29, 2012), 77
FR 33013 (June 4, 2012).
---------------------------------------------------------------------------

II. Description

    This rule change will amend Chapter 26 of ICC's rules to add
Section 26C to provide for the clearance of the CDX Emerging Markets
CDS contracts (``CDX.EM Contracts''), which reference an emerging
market sovereign index. ICC will list the five year tenor of Series 14,
15, 16 and 17 of the CDX.EM Contracts.
    CDX.EM Contracts have similar terms to the CDX North American Index
CDS contracts (``CDX.NA Contracts'') currently cleared by ICC and
governed by Section 26A of the ICC rules. Accordingly, the proposed
rules found in Section 26C largely mirror the ICC rules for CDX.NA
Contracts in Section 26A, with certain modifications that reflect the
underlying reference entities (sovereign reference entities instead of
corporate reference entities) and differences in terms and market
conventions between CDX.EM Contracts and CDX.NA Contracts. The CDX.EM
Contracts reference the CDX.EM index, the current series of which
consists of 15 emerging market sovereign entities: Argentina,
Venezuela, Brazil, Malaysia, Colombia, Hungary, Indonesia, Panama,
Peru, South Africa, the Philippines, Turkey, Russia, Ukraine, and
Mexico. CDX.EM Contracts, consistent with market convention and widely
used standard terms documentation, can be triggered by credit events
for failure to pay, restructuring, and repudiation/moratorium (by
contrast to the credit events of failure to pay and bankruptcy
applicable to the CDX.NA Contracts). CDX.EM Contracts will only be
denominated in U.S. dollars.
    ICC Rule 26C-102 (Definitions) sets forth the definition ICC uses
for its CDX.EM Contract rules. An ``Eligible CDX.EM Untranched Index''
is defined as ``each particular series and version of a CDX.EM index or
sub-index, as published by the CDX.EM Untranched Publisher, included
from time to time in the List of Eligible CDX.EM Untranched Indexes,''
which is a list maintained, updated, and published from time to time by
the ICC board of directors or its designee, containing certain
specified information with respect to each index. ``CDX.EM Untranched
Terms Supplement'' refers to the market standard form of documentation
used for credit default swaps on the CDX.EM index, which is
incorporated by reference into the contract specifications in Section
26C. The remaining definitions are substantially the same as the
definitions found in Section 26A of the ICC rules, other than certain
conforming changes.
    Rules 26C-309 (Acceptance of CDX.EM Untranched Contract), 26C-315
(Terms of the Cleared CDX.EM Untranched Contract), and 26C-316
(Updating Index Version of Fungible Contracts After a Credit Event or a
Succession Event; Updating Relevant Untranched Standard Terms
Supplement) reflect or incorporate the basic contract specifications
for CDX.EM Contracts and are substantially the same as under Section
26A of the ICC rulebook for CDX.NA Contracts. In addition to various
non-substantive conforming changes, proposed Rule 26C-317 (Terms of
CDX.EM Untranched Contracts) differs from the corresponding Rule 26A-
317 to reflect the fact that restructuring and repudiation/moratorium
are credit events for the CDX.EM Contract.
    In addition, a conforming change is being made to the definition of
``Restructuring CDS Contract'' in Section 26E (CDS Restructuring Rules)
to address components of CDX.EM Contracts that become subject to a
restructuring credit event. The treatment of such restructuring credit
events for CDX.EM Contracts will thus be as set forth in existing
Section 26E of the ICC rules.

III. Discussion

    Section 19(b)(2)(B) of the Act directs the Commission to approve a
proposed rule change of a self-regulatory organization if it finds that
such proposed rule change is consistent with the requirements of the
Act and the rules and regulations thereunder applicable to such
organization.\5\ 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 registered
clearing agency. Given the particular characteristics of the products
proposed to be cleared, the Commission carefully considered ICC's
ability to clear the CDX.EM Contracts in a manner that assures the
safeguarding of securities and funds which are in the custody and
control of ICC or for which ICC is responsible. After considering the
representations made by ICC regarding its belief that it would clear
CDX.EM Contracts in a manner that assures the safeguarding of
securities and funds, the Commission finds that the proposed rule
change is consistent with the requirements of the Act and the rules and
regulations thereunder.
---------------------------------------------------------------------------

    \5\ 15 U.S.C. 78s(b)(2)(B). For example, Section 17A(b)(3)(F) of
the Act requires, among other things, that the rules of a clearing
agency be designed to assure the safeguarding of securities and
funds in the custody or control of the clearing agency or for which
the clearing agency is responsible. 15 U.S.C. 78q-1(b)(3)(F). Though
the CDX.EM Contracts are not themselves securities, the safety and
soundness of the product directly impacts ICC's ability to safeguard
securities and funds in its custody or control or for which it is
responsible.
---------------------------------------------------------------------------

IV. Conclusion

    On the basis of the foregoing, the Commission finds that the
proposal is consistent with the requirements of the Act and in
particular with the requirements of Section 17A of the Act \6\ and the
rules and regulations thereunder.
---------------------------------------------------------------------------

    \6\ 15 U.S.C. 78q-1.
---------------------------------------------------------------------------

    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\7\ that the proposed rule change (File No. SR-ICC-2012-04) be, and
hereby is, approved.\8\
---------------------------------------------------------------------------

    \7\ 15 U.S.C. 78s(b)(2).
    \8\ In approving the proposed rule change, the Commission
considered the proposal's impact on efficiency, competition and
capital formation. 15 U.S.C. 78c(f).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\9\
---------------------------------------------------------------------------

    \9\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2012-16371 Filed 7-3-12; 8:45 am]
BILLING CODE 8011-01-P