	UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

     OFFICE OF

PREVENTION, PESTICIDES

AND TOXIC SUBSTANCES

MEMORANDUM

Date: June 12, 2008

SUBJECT:	ID#: 08MN03 Section 18 Emergency Exemption for the Use of
Chlorantraniliprole on Sweet Corn in Minnesota.

PC Code:  090100	DP Barcode:  351271

MRID No.:  None	Registration No.: 08MN03

Petition No.:  None	Regulatory Action: Section 18

Assessment Type:  Single Chemical Aggregate	Reregistration Case No.:
None

TXR No.:  None

FROM:	Barry O’Keefe, Senior Biologist

		Leung Cheng, Senior Chemist

		Jack Arthur, Senior Environmental Scientist

		Registration Action Branch 3

		Health Effects Division (7509P)

		Office of Pesticide Programs

THRU:	Paula Deschamp, Branch Chief

		Registration Action Branch 3

		Health Effects Division (7509P)

		Office of Pesticide Programs

TO:	Marcel Howard

		Section 18 Team

		Minor Use, Inerts and Emergency Response Branch

		Registration Division (7505P)

		Office of Pesticide Programs

The Registration Division (RD) of the Office of Pesticide Programs (OPP)
has requested that HED evaluate the Section 18 Emergency Exemption
request for the first time use of the insecticide chlorantraniliprole to
control corn earworm on sweet corn.

INTRODUCTION

A Section 18 Emergency Exemption request has been received for the
first-time use of the insecticide chlorantraniliprole to control corn
earworm on sweet corn in all counties in Minnesota on up to a total of
40,050 acres.  The use sites intended to be treated include sweet corn
for processing and fresh market.  The use season is from July 20th to
September 30th.  The product to be used is Coragen (EPA Reg. No.
352-729), a liquid formulation containing 18.4% active ingredient (ai)
and 1.667 lb ai per gallon.

EXECUTIVE SUMMARY

General Information

Chlorantraniliprole, or DPX-E2Y45, is a novel anthranilic diamide
insecticide that belongs to a class of compounds that acts on the
ryanodine receptor (Group 28 based on the target site of action).  It is
an insecticide that was developed by DuPont for control of lepidopteran
pests and controls many insects primarily via interruption of normal
muscle contraction pathways, which leads to paralysis and eventual death
of the pest.

DuPont has recently received approval for a Section 3 registration of
two agricultural end-use products (DupontTM CoragenTM SC Insecticide and
DupontTM AltacorTM WG Insecticide) and 13 products for use on turf and
ornamentals (DupontTM E2Y45 SC Insecticide, and 12 granular formulations
of varying concentrations ai).  Additionally the Louisiana Department of
Agriculture has recently received approval for a Section 18 exemption
for the use of DupontTM Dermacor X-100 Seed Treatment on rice seeds.
These actions required the establishment of tolerances for resulting
residues of
3-bromo-N-[4-chloro-2-methyl-6-[(methylamino)carbonyl]phenyl]-1-(3-chlor
o-2-pyridinyl)-1H-pyrazole-5-carboxamide in/on pome fruit, stone fruit,
leafy vegetables, Brassica leafy vegetables, cucurbit vegetables,
fruiting vegetables, cotton, grapes and potatoes and rice.

The proposed Section 18 use pattern for sweet corn is as follows: The
Minnesota Department of Agriculture has requested an emergency specific
exemption to use chlorantraniliprole (Coragen 20 SC a liquid insecticide
(EPA Reg. No. 352-TEO)) to control corn earworm on sweet corn in all
counties in Minnesota on up to a total of 40,050 acres.  This is the
first Section 18 request for this crop and use pattern.  The use sites
intended to be treated include sweet corn for processing and fresh
market.  The use season is from July 20th to September 30th.  The
maximum number of application will be two.  The proposed use is to apply
Coragen 20 SC by ground or aerial application methods at an application
rate of 0.045 to 0.098 lb ai/A and 3.5 to 7.5 fl oz/A per application,
with a maximum application rate of 0.2 lb ai/A per season.  The minimum
interval between treatments is one day.  A pre-harvest interval (PHI)
has not been specified; however, the residue data support a PHI of 1
day.

Toxicology

The toxicology database for chlorantraniliprole is considered adequate
for risk assessment and considered adequate for the characterization of
potential pre- and postnatal risks to infants and children.  The
chlorantraniliprole risk assessment team previously evaluated the
quality of the toxicity and exposure data and, based on these data,
recommended that the FQPA Safety Factor be reduced to 1x.

Chlorantraniliprole/DPX-E2Y45 has no significant acute toxicity via the
oral, dermal, and inhalation routes of exposure.  The LD50 for oral and
dermal acute exposure is ≥5000 mg/kg/day and the LC50 for acute
inhalation exposure is ≥5.1 mg/L.  This substance is not an eye or
skin irritant and does not cause skin sensitization.  In short-term
studies, the most consistent effects are those associated with non
adverse pharmacological response to the xenobiotic, induction of liver
enzymes and subsequent increase in liver weights.  DPX-E2Y45 is not
genotoxic, neurotoxic, immunotoxic, carcinogenic, or teratogenic.
Furthermore, it is not uniquely toxic to the conceptus as there were no
maternal or fetal effects in studies conducted in rats and rabbits.
Based on the results of a 28-day dermal study in rats, as well as the
dermal LD50 study, DPX-E2Y45 has relatively low dermal toxicity.

Overall, chlorantraniliprole exhibits minimal mammalian toxicity after
long-term exposure.  The only consistent observation in the mammalian
toxicology studies is an increased degree of microvesiculation of the
adrenal cortex after dermal or dietary administration of
chlorantraniliprole.  Based on the lack of an adverse effect on the
function of the adrenal gland, this observation was considered treatment
related, but not “adverse.”

In addition to the adrenal effects, liver effects (e.g., increased liver
weight and induction of Cytochrome P450 enzymes) were reported in the
90-day oral subchronic studies across species and only at the highest
dose tested (>1000 mg/kg/day).  While in the subchronic studies, these
effects were considered adaptive, the liver effects were more pronounced
in the 18-month chronic mouse study at the highest dose tested.
Increased eosinophilic foci (preneoplastic foci) were noted in male mice
at 935 mg/kg/day and liver hypertrophy and weight increase were evident
at the next lower dose (158 mg/kg/day), but progression to tumors was
not apparent for these effects.  Therefore, the eosinophilic foci appear
to be an adverse effect only seen in the highest dose tested and was
graded minimal in severity.

Dietary Exposure

The residue of concern in drinking water, plants and livestock for risk
assessment and tolerance enforcement is chlorantraniliprole (although
drinking water is not subject to tolerance enforcement).  Because
long-term oral exposure was the only route and duration where
chlorantraniliprole demonstrated toxicity (an adverse effect), only
chronic dietary (food and drinking water) exposure assessments were
conducted (using the dietary model DEEM-FCID).  The modeled exposure
estimates are based on tolerance level residues, assuming 100% of crops
associated with the Section 3 and 18 requests are treated, and include
the highest modeled EDWC relevant to the scenario.  Despite the
conservative assumptions on the exposure side, the resulting chronic
dietary exposures for all population subgroups were less than ≤1% of
the cPAD.

Non-Dietary, Non-Occupational Exposure

Residential exposure to chlorantraniliprole from existing uses is
expected.  The multitude of use sites, in addition to the persistence of
chlorantraniliprole, indicate there is potential for short- and
intermediate-term postapplication dermal (adults and children) and
incidental oral (children only) exposure to chlorantraniliprole
(inhalation exposure is not expected due to low vapor pressure).
However, due to the lack of toxicity via the dermal route, as well as
the lack of toxicity over the acute, short- and intermediate-term
durations via the oral route, no risk is expected from these exposures.

Aggregate Risk

Although there is potential residential exposure, there is no
residential hazard/risk associated with the route/duration of the
proposed uses; therefore, aggregate exposure is comprised of food and
water only, and is considered in the dietary section of this document.

Occupational Exposure

There is a potential for occupational short- and intermediate-term
inhalation and dermal exposure to chlorantraniliprole during mixing,
loading, application and postapplication activities.  However, the
chlorantraniliprole toxicology database indicates there is no systemic
hazard associated with short- and intermediate-term dermal and
inhalation exposure, and therefore, no occupational exposure and risk
assessment was conducted.

In addition to systemic hazard, the Worker Protection Standard (WPS)
sets an REI based on the acute toxicity of chemicals.  Technical
chlorantraniliprole is in Category IV for acute dermal toxicity and
Category IV for primary eye and skin irritation.  Per the WPS, a 12-hr
REI is required for chemicals classified under Toxicity Category III or
IV.  However, the Section 18 label submitted for chlorantraniliprole
indicates a proposed REI of 4 hours.  According to Pesticide
Registration (PR) Notice 95-3, EPA permits registrants to reduce REIs
from 12 to 4 hours for certain low risk pesticides that meet certain
criteria.  Chlorantraniliprole meets all of the criteria listed in PR
Notice 95-3, and therefore, is a candidate for a reduced REI of 4 hours.
 The minimum level of PPE for handlers is based on acute toxicity for
the end-use product.  The Registration Division (RD) is responsible for
ensuring that PPE listed on the label is in compliance with the Worker
Protection Standard (WPS).

Conclusion

HED has no concerns regarding human health exposure and risk from the
proposed Section 18 use of chlorantraniliprole on sweet corn for control
of earworms.  HED recommends time-limited tolerances for residues of
chlorantraniliprole

(3-bromo-N-[4-chloro-2-methyl-6-[(methylamino)carbonyl]phenyl]-1-(3-chlo
ro-2-pyridinyl)-1H-pyrazole-5-carboxamide) be established in/on the
following raw agricultural commodities:

	K+CWHR ....................................0.01 ppm

	Corn, sweet, forage .......................6.0 ppm

	Corn, sweet, stover ………………6.0 ppm

	Corn, sweet, cannery waste………6.0 ppm

	Milk……………………………. 0.03 ppm

NOTE:  There is an existing tolerance for milk associated with the
current Section 3 registrations.  The proposed S18 use on sweet corn
results in an increase in the livestock dietary burden and necessitates
an increase in the existing milk tolerance.  A temporary tolerance of
0.03 ppm is needed in association with the proposed Section 18 use on
sweet corn.

DETAILED DISCUSSION

Toxicological Considerations

The toxicology database for chlorantraniliprole is considered adequate
for risk assessment and considered adequate for the characterization of
potential pre- and postnatal risks to infants and children.  The
chlorantraniliprole risk assessment team previously evaluated the
quality of the toxicity and exposure data and, based on these data,
recommended that the FQPA Safety Factor be reduced to 1x.

Chlorantraniliprole/DPX-E2Y45 has no significant acute toxicity via the
oral, dermal, and inhalation routes of exposure.  The LD50 for oral and
dermal acute exposure is ≥5000 mg/kg/day and the LC50 for acute
inhalation exposure is ≥5.1 mg/L.  This substance is not an eye or
skin irritant and does not cause skin sensitization.  In short-term
studies, the most consistent effects are those associated with non
adverse pharmacological response to the xenobiotic, induction of liver
enzymes and subsequent increase in liver weights.  DPX-E2Y45 is not
genotoxic, neurotoxic, immunotoxic, carcinogenic, or teratogenic.
Furthermore, it is not uniquely toxic to the conceptus as there were no
maternal or fetal effects in studies conducted in rats and rabbits.
Based on the results of a 28-day dermal study in rats, as well as the
dermal LD50 study, DPX-E2Y45 has relatively low dermal toxicity.

Overall, chlorantraniliprole exhibits minimal mammalian toxicity after
long-term exposure.  The only consistent observation in the mammalian
toxicology studies is an increased degree of microvesiculation of the
adrenal cortex after dermal or dietary administration of
chlorantraniliprole.  Based on the lack of an adverse effect on the
function of the adrenal gland, this observation was considered treatment
related, but not “adverse.”

In addition to the adrenal effects, liver effects (e.g., increased liver
weight and induction of Cytochrome P450 enzymes) were reported in the
90-day oral subchronic studies across species and only at the highest
dose tested (>1000 mg/kg/day).  While in the subchronic studies, these
effects were considered adaptive, the liver effects were more pronounced
in the 18-month chronic mouse study at the highest dose tested.
Increased eosinophilic foci (preneoplastic foci) were noted in male mice
at 935 mg/kg/day and liver hypertrophy and weight increase were evident
at the next lower dose (158 mg/kg/day), but progression to tumors was
not apparent for these effects.  Therefore, the eosinophilic foci appear
to be an adverse effect only seen in the highest dose tested and was
graded minimal in severity.

Based on the weight of evidence of the available scientific data, and in
accordance with EPA’s Final Guidelines for Carcinogen Risk Assessment
(March 2005), chlorantraniliprole is classified as “Not Likely to Be
Carcinogenic to Humans”.

Dietary exposure via residues in/on food and drinking water are
aggregated in the chronic dietary assessment.  Aggregating routes and/or
pathways of exposure are not relevant for all other scenarios due to
lack of observed hazard for all other durations and exposure routes.

The toxicological doses (points of departure) and endpoints selected for
chlorantraniliprole are presented in the endpoint summary tables, i.e.,
Tables 1 and 2.

Table 1 Summary of Toxicological Doses and Endpoints for
Chlorantraniliprole for Use in Dietary and Non-Occupational Human Health
Risk Assessments

Exposure/

Scenario	Point of Departure	Uncertainty/FQPA Safety Factors	RfD, PAD,
Level of Concern for Risk Assessment	Study and Toxicological Effects

Acute Dietary (All Populations)	N/A	N/A	N/A	No acute hazard,
attributable to a single dose, was identified; therefore, an acute
dietary endpoint was not selected for quantitative risk assessment.

Chronic Dietary (All Populations)	NOAEL= 158 mg/kg/day	UFA= 10x

UFH=10x

FQPA SF= 1x	Chronic RfD = 1.58 mg/kg/day

cPAD = 1.58 mg/kg/day	18-Month Oral (feeding)/mouse

LOAEL = 935 mg/kg/day based on eosinophilic foci accompanied by
hepatocellular hypertrophy and increased liver weight (males only)

Incidental Oral Short-/Intermediate-Term 	N/A	N/A	N/A	There was no
hazard identified via the oral route over the short- and
intermediate-term and therefore, no endpoint was selected for
quantitative risk assessment.

Dermal Short-/Intermediate-Term 	N/A	N/A	N/A	There was no hazard
identified via the dermal route (and no concerns for developmental,
reproductive or neurotoxic effects) and therefore, no dermal endpoint
was selected for quantitative risk assessment.

Inhalation Short-/Intermediate-Term 	N/A	N/A	N/A	Based on the lack of
hazard identified in the acute inhalation study, lack of acute
irritation, and extremely low oral toxicity – no inhalation endpoint
was selected for quantitative risk assessment.

Cancer (oral, dermal, inhalation)	Classification:  “Not likely to be
Carcinogenic to Humans” based on weight of evidence of data: no
treatment-related tumors reported in the submitted chronic and
oncogenicity studies in rats and mice, subchronic studies in mice, dogs
and rats and that no mutagenic concern was reported in the genotoxicity
studies.

Table 2  Summary of Toxicological Doses and Endpoints for
Chlorantraniliprole for Use in Occupational Human Health Risk
Assessments

Exposure/

Scenario	Point of Departure	Uncertainty Factors	Level of Concern for
Risk Assessment	Study and Toxicological Effects

Dermal Short-/Intermediate-Term 	N/A	N/A	N/A	There was no hazard
identified via the dermal route (and no concerns for developmental,
reproductive or neurotoxic effects) and therefore, no dermal endpoint
was selected for quantitative risk assessment.

Inhalation Short-/Intermediate-Term 	N/A	N/A	N/A	Based on the lack of
hazard identified in the acute inhalation study, lack of acute
irritation, and extremely low oral toxicity – no inhalation endpoint
was selected for quantitative risk assessment.

Cancer (dermal, inhalation)	Classification:  “Not likely to be
Carcinogenic to Humans” based on weight of evidence of data: no
treatment-related tumors reported in the submitted chronic and
oncogenicity studies in rats and mice, subchronic studies in mice, dogs
and rats and that no mutagenic concern was reported in the genotoxicity
studies.

Point of Departure (POD) = A data point or an estimated point that is
derived from observed dose-response data and  used to mark the beginning
of extrapolation to determine risk associated with lower environmentally
relevant human exposures.  NOAEL = no observed adverse effect level.
LOAEL = lowest observed adverse effect level.  UF = uncertainty factor.
UFA = extrapolation from animal to human (interspecies).  UFH =
potential variation in sensitivity among members of the human population
(intraspecies).  FQPA SF = FQPA Safety Factor.  PAD = population
adjusted dose (c = chronic).  RfD = reference dose.  LOC = level of
concern.  N/A = not applicable

Residue Chemistry Considerations

Metabolism in Plants and Livestock

The nature of the residue in primary crops and rotational crops is
adequately understood.  In primary crops, chlorantraniliprole does not
metabolize to any great extent when applied as a foliar spray.  With up
to three consecutive foliar applications of chlorantraniliprole to
apples, tomatoes, and lettuce, and following a single application to
cotton, parent compound was the major component of the extracted
radioactivity in both human food and livestock feed items.  However,
when chlorantraniliprole was applied as a soil drench to rice crop, the
metabolism was demonstrated to be complex due to uptake from water
through roots, and numerous metabolites were identified in addition to
parent compound.   In rotational crops, the parent chlorantraniliprole
is the major component of the residue in following crops or succeeding
crops that were grown in soil previously treated with
chlorantraniliprole.  HED has determined that chlorantraniliprole is the
residue of concern in primary and rotational crop commodities for the
purposes of tolerance expression and risk assessment.

The nature of the residue in animals is adequately understood based on
acceptable ruminant and hen metabolism studies.  In the ruminant
metabolism study, parent was the major terminal residue identified in
kidney, muscle, and fat, and it was also a residue in liver and milk.
Metabolites were formed by N-demethylation, hydroxylation at the two
methyl groups, and/or cyclization to yield a pyrimidone ring.  In the
poultry study, chlorantraniliprole and its metabolites were eliminated
by the hen primarily in the excreta (>98% of the dose).  Parent was the
major residue in eggs and skin with fat, and was also detected in liver
and muscle.  The residue of concern in poultry and ruminant for
tolerance expression and risk assessment is chlorantraniliprole.

Analytical Enforcement Methodology

The LC/MS/MS method, DuPont-11374, was used for data collection and
subsequently proposed as an enforcement method for plant commodities.
Using this method, chlorantraniliprole is analyzed by LC/MS/MS operating
in the positive ionization mode.  The limit of quantification (LOQ) is
0.01 ppm for parent chlorantraniliprole.  The method for the
determination of chlorantraniliprole and its metabolites in processed
commodities is an LC/MS/MS method, DuPont-14314, which is a slightly
modified version of DuPont-11374.

The proposed enforcement method for livestock commodities is an LC/MS/MS
method described in MRID 46889003.  Detection is by Atmospheric Pressure
Chemical Ionization (APCI) MS/MS operated in the positive ion mode.  The
LOQ is reported at 0.010 ppm for parent and each of the metabolites.
The proposed plant and animal methods are adequate for tolerance
enforcement purposes (DP# 340358, C. Stafford, 2/6/08).

Chlorantraniliprole is not recovered by the U.S. FDA’s multi-residue
methods.

Magnitude of the Residues

IR-4 is currently conducting a magnitude of the residue study to support
registration on sweet corn in the U.S. and Canada.  The field trials
were conducted in 2007.

Coragen 20SC was applied twice at 0.1 lb ai/A/application at a
retreatment interval of one day.  The PHI was also one day.  Field
trials were conducted in NY, NJ, MD, FL, AZ, WA, ND, WI, MI, OR in the
U.S., and Ontario (3 trials) and Alberta, Canada.  A brief summary of
the residue data that accompanied this Section 18 request is based on
the results for WA, Ontario (2 trials), FL, MD, ND, NJ, NY and WI.

For K+CWHR residues were below the LOQ (0.01 ppm, N=18).  Residues in
treated forage samples (N=18) ranged from 0.94 ppm to 5.44 ppm.  All
control samples contained <0.01 ppm residues.

Based on the above residue data, HED recommends time-limited tolerances
be established on K+CWHR at 0.01 ppm, sweet corn forage at 6.0 ppm,
sweet corn stover at 6.0 ppm, and cannery waste at 6.0 ppm.

Sweet corn stover (83% DM) may be fed to beef cattle (10% in the diet),
and sweet corn forage (48% DM) and cannery waste (30% DM) may be fed to
dairy cattle (20% and 10%, respectively).  The inclusion of sweet corn
forage (2.5 ppm) and cannery waste (2.0 ppm) in the dairy cattle diet
resulted in a much higher dietary burden (4.6 ppm) than beef cattle
(0.78 ppm).  The construction of reasonably balanced dietary burdens in
beef and dairy cattle reflects the most recent guidance from HED
(Personal communication, 5/7/08, J. Stokes).

An adequate cattle feeding study is available.  Previously HED
recommended that tolerances at 0.01 ppm be established on milk, muscle,
fat, kidney and liver.  This Section 18 use on sweet corn could
potentially result in a significant increase in the dietary burden for
dairy cattle (from the previous estimate of 0.25 ppm to 4.6 ppm).  Given
the results of the cattle feeding study, HED recommends that the milk
tolerance be raised to 0.03 ppm, and the tolerances in muscle, fat,
kidney and liver remain unchanged at 0.01 ppm.

There are no poultry feeds associated with sweet corn commodities.
Therefore, the poultry dietary burden previously calculated remains
unchanged and the original conclusion that tolerances for eggs and
poultry are not needed remains valid.

Dietary (Food & Drinking Water) Exposure Analysis and Risk Estimates

Chronic exposure and risk estimates do not exceed HED’s level of
concern for the U.S. population.  Further, chronic exposure and risk
estimates do not exceed HED’s level of concern for all relevant
population subgroups (see Table 3).

The chronic dietary analysis was based on tolerance level residues and
100% crop treated assumption for all commodities.  The drinking water
values used in the chronic dietary risk assessment were based on
information provided by the Environmental Fate and Effects Division
(DPBarcode 351273, T. Nguyen, et. al., 5/14/08).  Exposure to
chlorantraniliprole was higher in the surface water (3.65 ppb) than
ground water (1.06 ppb).  The surface drinking water residue of 3.65 ppb
was incorporated in the DEEM-FCID into the food categories “water,
direct, all sources” and “water, indirect, all sources”.  These
estimated drinking water concentration (EDWC) inputs cover the sweet
corn use pattern.

Table 3.  Chronic Dietary Exposure and Risk Estimates for
Chlorantraniliprole

Population Subgroup	cPAD, mg/kg/day	Chronic Estimates

(Food only)	Chronic Estimates

(Food and Drinking Water)

Exposure, mg/kg/day	Risk, % cPAD	Exposure, mg/kg/day	Risk, % cPAD

U.S. Population	1.58	0.007814	0.5	0.007891	<1.0

All infants

0.008110	0.5	0.008362	<1.0

Children 1-2 yrs

0.015594	1.0	0.015708	1.0

Children 3-5 yrs

0.012513	0.8	0.012620	<1.0

Children 6-12 yrs

0.008274	0.5	0.008348	<1.0

Youth 13-19 yrs

0.005963	0.4	0.006019	<1.0

Adults 20-49 yrs

0.007148	0.5	0.007220	<1.0

Adults 50+ yrs

0.007679	0.5	0.007754	<1.0

Females 13-49 yrs

0.007286	0.5	0.007357	<1.0

The population subgroup with the highest estimated exposure/risk is
bolded.

Non-Dietary, Non-Occupational Exposure

Residential exposure to chlorantraniliprole from existing uses is
expected.  The multitude of use sites, in addition to the persistence of
chlorantraniliprole, indicate there is potential for short- and
intermediate-term postapplication dermal (adults and children) and
incidental oral (children only) exposure to chlorantraniliprole
(inhalation exposure is not expected due to low vapor pressure).
However, due to the lack of toxicity via the dermal route, as well as
the lack of toxicity over the acute, short- and intermediate-term via
the oral route – no risk is expected from these exposures.

Aggregate Risk

Although there is potential residential exposure, there is no
residential hazard/risk associated with the route/duration of the
proposed uses; therefore, aggregate exposure is comprised of food and
water only, and is considered in the dietary section of this document.

Occupational Considerations

There is a potential for occupational short- and intermediate-term
inhalation and dermal exposure to chlorantraniliprole during mixing,
loading, application and postapplication activities.  However, the
chlorantraniliprole toxicology database indicates there is no systemic
hazard associated with short- and intermediate-term dermal and
inhalation exposure, and therefore, no occupational exposure and risk
assessment was conducted.

In addition to systemic hazard, the Worker Protection Standard (WPS)
sets an REI based on the acute toxicity of chemicals.  Technical
chlorantraniliprole is in Category IV for acute dermal toxicity and
Category IV for primary eye and skin irritation.  Per the WPS, a 12-hr
REI is required for chemicals classified under Toxicity Category III or
IV.  However, the Section 18 label submitted for chlorantraniliprole
indicates a proposed REI of 4 hours.  According to Pesticide
Registration (PR) Notice 95-3, EPA permits registrants to reduce REIs
from 12 to 4 hours for certain low risk pesticides that meet certain
criteria.  Chlorantraniliprole meets all of the criteria listed in PR
Notice 95-3, and therefore, is a candidate for a reduced REI of 4 hours.
 The minimum level of PPE for handlers is based on acute toxicity for
the end-use product.  The Registration Division (RD) is responsible for
ensuring that PPE listed on the label is in compliance with the Worker
Protection Standard (WPS).

Cumulative Risk

 hž

␃༂킄⸂⼀㄀$♀帀킄愂Ȥ摧捷T

6

U

V

h

z

¬

Ì

ë

ì

í

T

Y

ê

ë

—

°

Ñ

hi

hi

h‘

h‘

gdi

gdi

gdi

Ò

a$gdi

gdi

gdi

gdi

gdi

gdi

gdi

gdi

gdi

gdi

gdi

gdi

gdi

gdi

gdi

gdi

gdi

gdi

)epa.gov/pesticides/cumulative/.

Conclusion

HED has no concerns regarding human health exposure and risk from the
proposed Section 18 use of chlorantraniliprole on sweet corn for control
of earworms.  HED recommends time-limited tolerances for residues of
chlorantraniliprole

(3-bromo-N-[4-chloro-2-methyl-6-[(methylamino)carbonyl]phenyl]-1-(3-chlo
ro-2-pyridinyl)-1H-pyrazole-5-carboxamide) be established in/on the
following raw agricultural commodities:

	K+CWHR ....................................0.01 ppm

	Corn, sweet, forage .......................6.0 ppm

	Corn, sweet, stover ………………6.0 ppm

	Corn, sweet, cannery waste………6.0 ppm

	Milk……………………………. 0.03 ppm

Page   PAGE  9  of   NUMPAGES  11


[Federal Register: April 2, 2007 (Volume 72, Number 62)]
[Notices]
[Page 15674]
[DOCID:fr02ap07-37]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP96-200-169]

CenterPoint Energy Gas Transmission Company; Notice of Negotiated
Rates

March 27, 2007.
    Take notice that on March 22, 2007, CenterPoint Energy Gas
Transmission Company (CEGT) tendered for filing as part of its FERC Gas
Tariff, Sixth Revised Volume No. 1, the following tariff sheets to be
effective April 1, 2007:

Sheet Nos. 809-849
Sheet Nos. 854-862
Sheet Nos. 883-890
Sheet Nos. 892-1999

    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211 and 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed in accordance with the provisions of
Section 154.210 of the Commission's regulations (18 CFR 154.210).
Anyone filing an intervention or protest must serve a copy of that
document on the Applicant. Anyone filing an intervention or protest on
or before the intervention or protest date need not serve motions to
intervene or protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov.
 Persons unable to file electronically should submit an

original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the

``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For

TTY, call<PHONE_NUMBER>.

Philis J. Posey,
Acting Secretary.
[FR Doc. E7-6004 Filed 3-30-07; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 78, Number 225 (Thursday, November 21, 2013)]
[Notices]
[Pages 69931-69932]
[FR Doc No: 2013-27950]

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

DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[Docket No. NHTSA-2012-0004; Notice 2]

Ford Motor Company, Grant of Petition for Decision of
Inconsequential Noncompliance

AGENCY: National Highway Traffic Safety Administration (NHTSA),
Department of Transportation (DOT).

ACTION: Grant of Petition.

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

SUMMARY: Ford Motor Company \1\ (Ford), has determined that certain
model year 2012 Ford Focus model passenger cars manufactured between
May 12, 2011 and May 18, 2011, do not fully comply with the
requirements of S5.2.1 of Federal Motor Vehicle Safety Standard (FMVSS)
No. 101, Controls and Displays and the requirements of S5.5.5 of FMVSS
No. 135, Light Vehicle Brake Systems. Ford has filed an appropriate
report pursuant to 49 CFR Part 573, Defect and Noncompliance
Responsibility and Reports, dated July 7, 2011.
---------------------------------------------------------------------------

    \1\ Ford Motor Company is a motor vehicle manufacturer
incorporated under the laws of the state of Delaware.
---------------------------------------------------------------------------

    Pursuant to 49 U.S.C. 30118(d) and 30120(h) and the rule
implementing those provisions at 49 CFR part 556, Ford has petitioned
for an exemption from the notification and remedy requirements of 49
U.S.C. Chapter 301 on the basis that this noncompliance is
inconsequential to motor vehicle safety.
    Notice of receipt of Ford's petition was published, with a 30-day
public comment period, on February 2, 2012 in the Federal Register (77
FR 5302). No comments were received. To view the petition, and all
supporting documents log onto the Federal Docket Management System
(FDMS) Web site at: http://www.regulations.gov/. Then follow the online
search instructions to locate docket number ``NHTSA-2012-0004.''
    Contact Information: For further information on this decision
contact Mr. Stuart Seigel, Office of Vehicle Safety Compliance, the
National Highway Traffic Safety Administration (NHTSA), telephone (202)
366-5287, facsimile<PHONE_NUMBER>.
    Vehicles Involved: Affected are approximately 485 model year 2012
Ford Focus passenger cars that were manufactured at Ford's Michigan
Assembly Plant between May 12, 2011 and May 18, 2012.
    Summary of Ford's Analyses: Ford explains that the affected
vehicles display a red International Standards Organization (ISO)
symbol for the brake telltale and warning indicator within the
instrument cluster instead of the word ``BRAKE'' as required in FMVSS
No. 101 and FMVSS No. 135.
    Ford stated its belief that although the instrument cluster
telltale symbols are displayed using ISO symbols the noncompliance is
inconsequential to motor vehicle safety for the following reasons:
    (1) The Owners Guide for the subject vehicles is written for
multiple markets and depicts both the ``BRAKE'' and ISO symbol
telltales for brake warning conditions.
    (2) Paragraph S5.5.1 of FMVSS No. 135 states that the warning
indicator must identify a gross loss of fluid or fluid pressure and
identify if the parking brake is applied and is satisfied by a separate
ABS lamp which complies with all requirements of FMVSS No. 135 and
FMVSS No. 101.
    (3) In the event that the brake fluid level in the master cylinder
reservoir is less than the recommended safe level, the ISO symbol will
illuminate and a warning message will display in the Message Center
that states ``BRAKE FLUID LEVEL LOW SERVICE NOW'' and an initial
warning chime will sound. The message will stay continuously displayed
until acknowledged by the operator, provided there are no other serious
message(s), which would result in the messages alternating. If the
brake fluid is still low on subsequent key cycles the message will be
redisplayed in the message center. If the message is acknowledged by
the operator a red ``i'' is illuminated on the instrument cluster
noting that an important message is stored and can be re-accessed by
requesting a System Check.
    (4) The parking brake in the subject vehicle is set by pulling up
on the parking brake handle, which is located on the center console
adjacent to the gear shift lever. Thus the application of the parking
brake is in full view of the operator. When the parking brake is
engaged it illuminates the ISO symbol and should the operator proceed
with the parking brake engaged, a warning message ``PARK BRAKE
APPLIED'' and an initial audible chime will sound when the vehicle is
driven at six miles per hour or greater for more than five seconds, in
addition to the vehicle feedback of a lack of acceleration. The warning
message will time out after ten seconds but a red ``i'' remains
illuminated noting that an important message is stored and can be re-
accessed by requesting a System Check. If the operator continues to
drive with the parking brake engaged, after 30 seconds the warning
message ``PARK BRAKE APPLIED'' will return, along with a warning chime.
    (5) In all cases the ISO symbol for the brake telltale illuminates
and remains illuminated in accordance with the requirements of FMVSS
No. 135.
    (6) Ford is unaware of any field or owner complaints regarding the
issue of non-compliant telltales.
    In summation, Ford believes that the described noncompliance of its
vehicles is inconsequential to motor vehicle safety, and that its
petition, to exempt it from providing recall notification of
noncompliance as required by 49 U.S.C. 30118 and remedying the recall
noncompliance as required by 49 U.S.C. 30120 should be granted.
    Requirement Background: FMVSS No. 101 S5.2.1 and S5.5.2
specifically state:

    S5.2.1 Except for the Low Tire Pressure Telltale, each control,
telltale and indicator that is listed in column 1 of Table 1 or
Table 2 must be identified by the symbol specified for it in column
2 or the word or abbreviation specified for it in column 3 of Table
1 or Table 2. If a symbol is used, each symbol provided pursuant to
this paragraph must be substantially similar in form to the symbol
as it appears in Table 1 or Table 2. If a symbol is used, each
symbol provided pursuant to this paragraph must have the
proportional dimensional characteristics of the symbol as it appears
in Table 1 or Table . . .
    S5.5.2 The telltales for any brake system malfunction required
by Table 1 to be red, air bag malfunction, low tire pressure,
electronic stability control malfunction (as of September 1, 2011),
passenger air bag off, high beam, turn signal, and seat belt must
not be shown in the same common space.

    Additionally, Table 1 Note 9 states:

    Refer to FMVSS 105 of FMVSS 135, as appropriate, for additional
specific requirements for brake telltale labeling and color. If a
single telltale is to be used to indicate more than one brake system
condition, the brake system malfunction identifier must be used.

    FMVSS No. 135 S5.5.5 specifically states:

    (a) Each visual indicator shall display a word or words in
accordance with the requirements of Standard No. 101 (49 CFR
571.101) and this section, which shall be legible to the driver
under all daytime and nighttime conditions when activated. Unless
otherwise specified, the words shall have letters not less than 3.2
mm (\1/8\ inch) high and the letters and background shall be of
contrasting colors, one of which is red. Words or symbols in
addition to those required by Standard No. 101 and this section may
be provided for purposes of clarity.
    (b) Vehicles manufactured with a split service brake system may
use a common brake warning indicator to indicate two or more of the
functions described in S5.5.1(a)

through S5.5.1(g). If a common indicator is used, it shall display
the word ``Brake'' (emphasis added).

    NHTSA Analysis and Reasoning: Ford stated that there are two
conditions which will cause the brake system warning indicator, located
on the instrument cluster and labeled with an ISO symbol instead of
BRAKE, to illuminate:
    1. The brake fluid level in the master cylinder reservoir is less
than the recommended safe level; and
    2. The parking brake control, a handle located on the center
console, is applied.
    Ford also stated that each warning to the driver includes an
audible chime and a warning message in the vehicle's message center.
The message ``brake fluid low service now'' would remain illuminated
until brake fluid is added. However, that message may alternate with
other serious message(s) should they appear. If the vehicle's parking
brake is applied, an audible chime will sound when the vehicle reaches
6 mph for more than 5 seconds. The message ``park brake applied'' will
time out after 10 seconds, but it will be stored in the message
information center for subsequent retrieval by the driver. In addition,
the parking brake control is readily visible to the driver and the
vehicle will lack acceleration if the parking brake is applied. For
either or both conditions 1 and 2, the red brake system warning
indicator labeled with the ISO symbol will remain illuminated until the
problem is corrected.
    We believe that the combination of the red color of the ISO symbol,
the audible chimes, message center warnings, and additionally for the
parking brake, the position of the applied lever and reduced
drivability, all described in the owner's manual, will be sufficient to
adequately warn the driver should these serious problems in the braking
system occur, even in the absence of the required BRAKE label on the
indicator. The manufacturer has shown that the discrepancy with the
safety requirement is unlikely to lead to any misunderstanding
especially since other sources of correct information beyond the ISO
symbol are available. We also believe the ISO symbol has over time
evolved to become more recognizable and understandable to drivers. In
addition, NHTSA has not received any consumer complaints regarding the
subject vehicles.
    NHTSA Decision: In consideration of the foregoing, NHTSA has
determined that Ford has met its burden of persuasion that the FMVSS
No. 101 and 135 noncompliance for the BRAKE telltale is inconsequential
to motor vehicle safety. Accordingly, Ford's petition is hereby
granted.
    NHTSA notes that the statutory provisions (49 U.S.C. 30118(d) and
30120(h)) that permit manufacturers to file petitions for a
determination of inconsequentiality allow NHTSA to exempt manufacturers
only from the duties found in sections 30118 and 30120, respectively,
to notify owners, purchasers, and dealers of a defect or noncompliance
and to remedy the defect or noncompliance. Therefore, this decision
only applies to the 485 vehicles that Ford no longer controlled at the
time that it determined that a noncompliance existed in the subject
vehicles. However, the granting of this petition does not relieve
vehicle distributors and dealers of the prohibitions on the sale, offer
for sale, or introduction or delivery for introduction into interstate
commerce of the noncompliant vehicles under their control after Ford
notified them that the subject noncompliance existed.

    Authority: 49 U.S.C. 30118, 30120: delegations of authority at
CFR 1.95 and 501.8.

    Issued on: November 18, 2013.
Claude H. Harris,
Director, Office of Vehicle Safety Compliance.
[FR Doc. 2013-27950 Filed 11-20-13; 8:45 am]
BILLING CODE 4910-59-P


[Federal Register: March 24, 2009 (Volume 74, Number 55)]
[Notices]
[Page 12407-12408]
[DOCID:fr24mr09-131]

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

SECURITIES AND EXCHANGE COMMISSION

[Investment Company Act Release No. 28650; 812-13538]

ING Investments, LLC, et al.; Notice of Application

March 17, 2008.
AGENCY: Securities and Exchange Commission (``Commission'').

ACTION: Notice of an application under section 6(c) of the Investment
Company Act of 1940 (``Act'') for an exemption from rule 12d1-2(a)
under the Act.

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

Summary of Application: Applicants request an order to permit funds of
funds relying on rule 12d1-2 under the Act to invest in certain
financial instruments.
    Applicants: ING Investments, LLC (``IIL''), Directed Services, LLC
(``DSL''), ING Investment Management Co. (``IIM''), ING Funds
Distributor, LLC (``IFD'') and ING Investors Trust, ING Partners, Inc.,
ING Mutual Funds, ING Series Funds, Inc., and ING Strategic Allocation
Portfolios, Inc. (collectively, the ``Trusts'').
    Filing Dates: The application was filed on June 4, 2008, and
amended on March 13, 2009.
    Hearing or Notification of Hearing: An order granting the
application will be issued unless the Commission orders a hearing.
Interested persons may request a hearing by writing to the Commission's
Secretary and serving applicants with a copy of the request, personally
or by mail. Hearing requests should be received by the Commission by
5:30 p.m. on April 13, 2009 and should be accompanied by proof of
service on applicants, in the form of an affidavit or, for lawyers, a
certificate of service. Hearing requests should state the nature of the
writer's interest, the reason for the request, and the issues
contested. Persons who wish to be notified of a hearing may request
notification by writing to the Commission's Secretary.

ADDRESSES: Secretary, Securities and Exchange Commission, 100 F Street,
NE., Washington, DC 20549-1090; Applicants, c/o Huey P. Falgout, Jr.,
ING Investments, LLC, 7337 E. Doubletree Ranch Road, Scottsdale, AZ
85258.

FOR FURTHER INFORMATION CONTACT: Lewis Reich, Senior Counsel, at (202)
551-6919, or Janet M. Grossnickle, Assistant Director, at (202) 551-
6821 (Division of Investment Management, Office of Investment Company
Regulation).

SUPPLEMENTARY INFORMATION: The following is a summary of the
application. The complete application may be obtained for a fee at the
Commission's Public Reference Room, 100 F Street, NE., Washington, DC
20549-1520 (telephone<PHONE_NUMBER>).

Applicants' Representations

    1. ING Investors Trust is organized as a Massachusetts business
trust. ING Mutual Funds is organized as a Delaware statutory trust.
Each of the other Trusts is organized as a Maryland corporation. Each
Trust is registered

under the Act as an open-end management investment company. Each of
IIL, DSL and IIM and is registered as an investment adviser under the
Investment Advisers Act of 1940, as amended, and currently serves as an
investment adviser or sub-adviser to existing series of the Trust. IFD,
a Delaware corporation, is registered as a broker-dealer under the
Securities Exchange Act of 1934, as amended (``Exchange Act''). IFD
currently serves as the distributor of the existing series of the
Trust. The Trusts and each existing or future registered open-end
management investment company or series thereof that is in the same
group of investment companies, as defined in section 12(d)(1)(G)(ii) of
the Act, as the Trusts and that is advised by IIL, DSL or IIM or any
entity controlling, controlled by or under common control with IIL, DSL
or IIM (the ``Advisers''), together with series of the Trusts are
referred to as the ``Funds.'' Applicants request the exemption to the
extent necessary to permit any Fund that may invest in other funds in
reliance on Section 12(d)(1)(G) of the Act, and which is also eligible
to invest in securities (as defined in section 2(a)(36) of the Act) in
reliance on rule 12d1-2 under the Act, to also invest, to the extent
consistent with its investment objective, policies, strategies and
limitations, in financial instruments that may not be securities within
the meaning of section 2(a)(36) of the Act (``Other Investments'').\1\
---------------------------------------------------------------------------

    \1\ Every existing entity that currently intends to rely on the
requested order is named as an applicant. Any existing or future
entity that relies on the order in the future will do so only in
accordance with the terms and condition in the application.
---------------------------------------------------------------------------

    2. Consistent with its fiduciary obligations under the Act, each
Fund's board of trustees or directors will review the advisory fees
charged by the Fund's investment adviser to ensure that they are based
on services provided that are in addition to, rather than duplicative
of, services provided pursuant to the advisory agreement of any
investment company in which the Fund may invest.

Applicants' Legal Analysis

    1. Section 12(d)(1)(A) of the Act provides that no registered
investment company (``acquiring company'') may acquire securities of
another investment company (``acquired company'') if such securities
represent more than 3% of the acquired company's outstanding voting
stock or more than 5% of the acquiring company's total assets, or if
such securities, together with the securities of other investment
companies, represent more than 10% of the acquiring company's total
assets. Section 12(d)(1)(B) of the Act provides that no registered
open-end investment company may sell its securities to another
investment company if the sale will cause the acquiring company to own
more than 3% of the acquired company's voting stock, or cause more than
10% of the acquired company's voting stock to be owned by investment
companies.
    2. Section 12(d)(1)(G) of the Act provides that section 12(d)(1)
will not apply to securities of an acquired company purchased by an
acquiring company if: (i) the acquiring company and acquired company
are part of the same group of investment companies; (ii) the acquiring
company holds only securities of acquired companies that are part of
the same group of investment companies, government securities, and
short-term paper; (iii) the aggregate sales loads and distribution-
related fees of the acquiring company and the acquired company are not
excessive under rules adopted pursuant to section 22(b) or section
22(c) of the Act by a securities association registered under section
15A of the Exchange Act or by the Commission; and (iv) the acquired
company has a policy that prohibits it from acquiring securities of
registered open-end management investment companies or registered unit
investment trusts in reliance on section 12(d)(1)(F) or (G) of the Act.
    3. Rule 12d1-2 under the Act permits a registered open-end
investment company or a registered unit investment trust that relies on
section 12(d)(1)(G) of the Act to acquire, in addition to securities
issued by another registered investment company in the same group of
investment companies, government securities, and short-term paper: (1)
Securities issued by an investment company that is not in the same
group of investment companies, when the acquisition is in reliance on
section 12(d)(1)(A) or 12(d)(1)(F) of the Act; (2) securities (other
than securities issued by an investment company); and (3) securities
issued by a money market fund, when the investment is in reliance on
rule 12d1-1 under the Act. For the purposes of rule 12d1-2,
``securities'' means any security as defined in section 2(a)(36) of the
Act.
    4. Section 6(c) of the Act provides that the Commission may exempt
any person, security, or transaction from any provision of the Act, or
from any rule under the Act, if such exemption is necessary or
appropriate in the public interest and consistent with the protection
of investors and the purposes fairly intended by the policies and
provisions of the Act.
    5. Applicants state that the proposed arrangement would comply with
the provisions of rule 12d1-2 under the Act, but for the fact that the
Funds may invest a portion of their assets in Other Investments.
Applicants request an order under section 6(c) of the Act for an
exemption from rule 12d1-2(a) to allow the Funds to invest in Other
Investments. Applicants assert that permitting the Funds to invest in
Other Investments as described in the application would not raise any
of the concerns that the requirements of section 12(d)(1) were designed
to address.

Applicants' Condition

    Applicants agree that the order granting the requested relief will
be subject to the following condition:
    Applicants will comply with all provisions of rule 12d1-2 under the
Act, except for paragraph (a)(2) to the extent that it restricts any
Fund from investing in Other Investments as described in the
application.

    For the Commission, by the Division of Investment Management,
under delegated authority.
Florence E. Harmon,
Deputy Secretary.
[FR Doc. E9-6391 Filed 3-23-09; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 84, Number 166 (Tuesday, August 27, 2019)]
[Notices]
[Page 44900]
[FR Doc No: 2019-18410]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-3612]

Vaccines and Related Biological Products Advisory Committee;
Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or the Agency) announces
a forthcoming public advisory committee meeting of the Vaccines and
Related Biological Products Advisory Committee (VRBPAC). The general
function of the committee is to provide advice and recommendations to
the Agency on FDA's regulatory issues. At least one portion of the
meeting will be closed to the public. Members will participate via
teleconference.

DATES: The meeting will be held on October 9, 2019, from 8:30 a.m. to
3:30 p.m.

ADDRESSES: FDA White Oak Campus, 10903 New Hampshire Avenue, Bldg. 31
Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993-
0002. For those unable to attend in person, the meeting will also be
webcast and will be available at the following link: https://collaboration.fda.gov/vrbpac100919/. Answers to commonly asked
questions including information regarding special accommodations due to
a disability, visitor parking, and transportation may be accessed at:
https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.

FOR FURTHER INFORMATION CONTACT: Capt. Serina Hunter-Thomas, Center for
Biologics Evaluation and Research, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm. 6338, Silver Spring, MD 20993-0002,
240-402-5771<EMAIL_ADDRESS>or FDA Advisory
Committee Information Line, 1-800-741-8138<PHONE_NUMBER> in the
Washington, DC area). 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 website
at https://www.fda.gov/AdvisoryCommittees/default.htm and scroll down
to the appropriate advisory committee meeting link, or call the
advisory committee information line to learn about possible
modifications before coming to the meeting.

SUPPLEMENTARY INFORMATION:
    Agenda: On October 9, 2019, under topic I, the Center for Biologics
Evaluation and Research's (CBER) VRBPAC will meet in open session to
hear an overview of the research programs in the Laboratory of
Hepatitis Viruses (LIR) and the Laboratory of Vector-Borne Viral
Diseases (LVVD), Division of Viral Products, Office of Vaccines
Research and Review, CBER, FDA. Also, on October 9, 2019, under topic
II, the committee will meet in open session to discuss and make
recommendations on the selection of strains to be included in an
influenza virus vaccine for the 2020 southern hemisphere influenza
season.
    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 website 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 website after the meeting. Background material is
available at https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting
link.
    Procedure: On October 9, 2019, from 8:30 a.m. to approximately 10
a.m. and from 11 a.m. to 3:30 p.m., the meeting is open to the public.
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 October 2, 2019. Oral
presentations from the public will be scheduled between approximately
9:45 a.m. and 10 a.m. for the overview portion of the LHV/LVVD Site
Visit (topic I), and from 1:30 p.m. to 2:15 p.m. for the influenza
strain selection portion of the meeting (topic II). 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 September 24, 2019.
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 September 25, 2019.
    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
disabilities. If you require accommodations due to a disability, please
contact Capt. Serina Hunter-Thomas at least 7 days in advance of the
meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our website at: https://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: August 16, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-18410 Filed 8-26-19; 8:45 am]
 BILLING CODE 4164-01-P


Comment Info: =================

General Comment:Dear Mr. Zeller:

I am writing as an individual consumer to request an extension of the comment period for the Food and Drug Administration's ("FDA") Proposed Rule Deeming Tobacco Products to be Subject to the Federal Food, Drug, and Cosmetic Act, as amended by the Family Smoking and Prevention and Tobacco Control Act (the "Proposed Rule") published at 79 Fed. Reg. 23,142 and Federal Register No. 2014-09491. On behalf of myself, I am requesting that the comment period for the Proposed Rule be extended by the FDA for an additional 105 days, from its current 75-day period, to 180 days.

The Proposed Rule raises a number of significant issues and questions that are important and relevant to me, as a consumer of products that are proposed for regulation under the Proposed Rule. The Proposed Rule asks arround a hundred different questions I might want to respond to. I want to provide my thoughts and comments on many of these issues, but my time to devote to researching and providing thoughtful comments on these important questions is limited. I have already spent many hours researching and dissecting these issues, but they will take time. I know that the FDA took many years to even come up with the Proposed Rule, so I do not think it is at all unreasonable to allow the public a mere six months to comment on it. This is our only opportunity, as consumers, to provide our feedback.

I feel very strongly about e-cigarettes as an alternative to combustible cigarettes. Quite simply, I firmly believe that they saved my life. As well as improved my lifestyle. As a healthcare worker I feel quality of life to be a major issue in which I wish to provide you with my personal story, as well as science- and evidence-based responses to your questions so that you can take my and others comment into account. I realize that the FDA has the authority under 21 CFR 10.40 to extend this time frame and that the FDA has exercised this authority on numerous occasions in the past. I would therefore ask that you do so here, so that all stakeholders have the opportunity to provide their comments on this proposed regulation.

I appreciate your consideration of my request and am happy to discuss this issue with you further.


[Federal Register Volume 79, Number 241 (Tuesday, December 16, 2014)]
[Notices]
[Pages 74796-74797]
[FR Doc No: 2014-29360]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-73804; File No. SR-DTC-2014-10)]

Self-Regulatory Organizations; The Depository Trust Company;
Order Approving Proposed Rule Change in Connection With the
Modifications To Require Receiver Authorized Delivery Approval for DTC
Processing of Institutional Delivery Transactions

December 10, 2014.

I. Introduction

    On October 16, 2014, The Depository Trust Company (``DTC'') filed
with the Securities and Exchange Commission (``Commission'') proposed
rule change SR-DTC-2014-10 (``Proposed Rule Change'') 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 November 3, 2014.\3\ The
Commission did not receive any comments on the Proposed Rule Change.
This order approves the Proposed Rule Change.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ Securities Exchange Act Release No. 73443 (Oct. 28, 2014),
79 FR 65268 (Nov. 3, 2014).
---------------------------------------------------------------------------

II. Description

    DTC filed the Proposed Rule Change to modify the DTC Settlement
Service Guide (``Guide'') to require DTC Participants \4\ to use the
Receiver Authorized Delivery (``RAD'') function to accept any affirmed
institutional delivery transaction (``ID Transaction'') prior to DTC
processing of the delivery. With the Proposed Rule Change, DTC seeks to
reduce uncertainty in the settlement of ID Transactions.
---------------------------------------------------------------------------

    \4\ Terms not defined herein have the meaning set forth in DTC's
Rules, By-Laws, and Organization Certificate (``Rules''), available
at http://dtcc.com/~/media/Files/Downloads/legal/rules/
dtc_rules.ashx.
---------------------------------------------------------------------------

    Pursuant to a recent rule change,\5\ DTC requires all non-
institutional Deliver Orders and Payment Orders \6\ to be approved
through RAD. RAD enables a receiver of valued deliveries of securities
(``Receiver'') to manage which deliveries to accept, or to reject,
prior to further processing by DTC. With this process, DTC seeks to
establish a consistent internal ``matching'' system for book-entry
deliveries at DTC.
---------------------------------------------------------------------------

    \5\ Securities Exchange Act Release No. 72576 (Jul. 9, 2014); 79
FR 41335 (Jul. 15, 2014) (SR-DTC-2014-06).
    \6\ A Deliver Order is a book-entry movement of a particular
security between two Participants. A Payment Order is a method for
settling funds related to transactions and payments not associated
with a Deliver Order.
---------------------------------------------------------------------------

    ID Transactions generally have not required RAD approval because
the transactions are externally pre-matched through Omgeo, LLC,\7\
although Participants were permitted to apply RAD voluntarily.\8\
Because RAD was not required, a Receiver could use the same-day reclaim
process to return securities to the original Participant delivering
securities (``Deliverer'') without the acceptance of the Deliverer. DTC
states that this process creates uncertainty for Participants and DTC
as to whether securities will be delivered or reclaimed on the same day
without the prior acceptance of the Receiver or original Deliverer.
---------------------------------------------------------------------------

    \7\ Omgeo is a leading provider of post-trade, pre-settlement
institutional trade management solutions, processing over one
million trades per day, and servicing approximately 6,500 investment
managers, broker/dealers, and custodians in over 50 countries. See
About DTCC: Omgeo LLC, http://dtcc.com/about/businesses-and-subsidiaries/omgeo.aspx.
    \8\ Receivers may optionally set their DTC profile to route ID
Transactions to RAD.
---------------------------------------------------------------------------

    Pursuant to the Proposed Rule Change, DTC will amend the Guide to
eliminate this uncertainty by requiring the intended Receiver to
approve the ID Transaction in RAD before DTC processes the
transaction.\9\ Same-day reclaims will also be subject to RAD approval
by the original Deliverer, as though the reclaim was its own, separate
transaction. As with any securities delivery, these transactions will
be subject to DTC's risk management controls.\10\
---------------------------------------------------------------------------

    \9\ For processing efficiency, the proposed change to the Guide
will offer Participants the option to set their system profile to
allow affirmed ID Transactions to be automatically accepted in RAD.
However, Participants will no longer have an option to allow ID
Transactions to bypass RAD.
    \10\ DTC risk management controls, including Collateral Monitor
and Net Debit Cap (as defined in DTC Rule 1), are designed so that
DTC may complete system-wide settlement notwithstanding the failure
to settle of its largest Participant or affiliated family of
Participants. The Collateral Monitor tests that a Receiver has
adequate collateral to secure the amount of its net debit balance
and the Net Debit Cap limits the net debit balance of a Participant
so that it cannot exceed DTC liquidity resources for settlement. See
DTC Rules, http://dtcc.com/~/media/Files/Downloads/legal/rules/
dtc_rules.ashx.
---------------------------------------------------------------------------

    Additionally, with the Proposed Rule Change DTC will make technical
updates to the Guide: (i) update the text for consistency to reflect
that all valued Deliver Orders, Payment Orders, ID Transactions, MMI
transactions, reclaims, pledges, and releases of pledged securities
will be subject to RAD; (ii) update the text for consistency to reflect
that all reclaims will be subject to risk management controls and
remove references to system functions related to reclaims that have
become obsolete; (iii) add an email address to which Settling Banks
seeking to adjust Net Debit Caps may send their requests, in addition
to via mail or overnight delivery to the existing mailing address; (iv)
indicate where Participants may access certain system functions via
Settlement Web either in addition to, or in lieu of, PBS/PTS; (v)
eliminate references to fees relating to the ID Net service, which are
redundant since those fees are also listed in DTC's fee schedule; and
(vi) delete reference to the population of a ``third party'' field on
DTC's system screens for the ID Net service, which is no longer
applicable.
    The effective date of the Proposed Rule Change, including the dates
of the implementation phases described above,

will be announced via a DTC Important Notice.

III. Discussion

    Section 19(b)(2)(C) of the Act \11\ 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 rules and regulations thereunder applicable
to such organization. Section 17A(b)(3)(F) of the Act requires, among
other things, that the rules of a clearing agency be designed to
promote the prompt and accurate clearance and settlement of securities
transactions.\12\ In addition, Rule 17Ad-22(d)(12) of the Act requires
that a clearing agency establish, implement, maintain and enforce
written policies and procedures reasonably designed to ensure that
final settlement occurs no later than the end of the settlement day and
require that intraday or real-time finality be provided where necessary
to reduce risks.\13\
---------------------------------------------------------------------------

    \11\ 15 U.S.C. 78s(b)(2)(C).
    \12\ 15 U.S.C. 78q-1(b)(3)(F).
    \13\ 17 CFR 240.17Ad-22(d)(12).
---------------------------------------------------------------------------

    The Commission finds the Proposed Rule Change consistent with the
Act. More specifically, as the Proposed Rule Change pertains to
requiring acceptance through RAD of any affirmed ID Transaction, the
Commission finds that the Proposed Rule Change is consistent with
Section 17A(b)(3)(F) of the Act \14\ because the change will increase
the number of deliveries that will require Receiver approval prior to
DTC processing. This requirement will reduce the intraday uncertainty
and associated risks that may currently arise from same-day reclaims,
thus facilitating the prompt and accurate clearance and settlement of
securities transactions. The Commission also finds these aspects of the
Proposed Rule Change consistent with Rule 17Ad-22(d)(12) under the Act
\15\ because more transactions will be subject to DTC's risk management
controls, which helps ensure that final settlement occurs no later than
the end of the settlement day.
---------------------------------------------------------------------------

    \14\ 15 U.S.C. 78q-1(b)(3)(F).
    \15\ 17 CFR 240.17Ad-22(d)(12).
---------------------------------------------------------------------------

    As the Proposed Rule Change pertains to the proposed technical
changes, the Commission finds that the Proposed Rule Change is also
consistent with Section 17A(b)(3)(F) of the Act \16\ because updates to
the Guide to make it more clear, consistent, and current supports the
prompt and accurate clearance and settlement of securities
transactions.
---------------------------------------------------------------------------

    \16\ 15 U.S.C. 78q-1(b)(3)(F).
---------------------------------------------------------------------------

IV. Conclusion

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

    \17\ 15 U.S.C. 78q-1.
---------------------------------------------------------------------------

    It is therefore ordered, pursuant to Section 19(b)(2) of the Act,
that proposed rule change SR-DTC-2014-10 be, and hereby is,
approved.\18\
---------------------------------------------------------------------------

    \18\ 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.\19\
---------------------------------------------------------------------------

    \19\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2014-29360 Filed 12-15-14; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 80, Number 23 (Wednesday, February 4, 2015)]
[Rules and Regulations]
[Pages 5909-5911]
[FR Doc No: 2015-01282]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2014-0462; Directorate Identifier 2014-NE-06; Amendment
39-18075; AD 2015-02-08]
RIN 2120-AA64

Airworthiness Directives; Rolls-Royce Corporation Turboprop and
Turbofan Engines (Type Certificate Previously Held by Allison Engine
Company)

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: We are adopting a new airworthiness directive (AD) for certain
Rolls-Royce Corporation (RRC) AE 2100 series turboprop engines and AE
3007A and 3007C series turbofan engines. This AD was prompted by
reports of pitting in the wheel bores and subsequent RRC analysis that
concluded that lower life limits are needed for the affected turbine
wheels. This AD requires a reduction for the approved life limits of
the affected turbine wheels. This AD also requires an eddy current
inspection (ECI) of certain RRC engines with affected turbine wheels.
We are issuing this AD to prevent uncontained failure of the turbine
wheels, damage to the engine, and damage to the airplane.

DATES: This AD is effective March 11, 2015.
    The Director of the Federal Register approved the incorporation by
reference of certain publications listed in this AD as of March 11,
2015.

ADDRESSES: For service information identified in this AD, contact
Rolls-Royce Corporation, 450 South Meridian Street, Mail Code NB-01-06,
Indianapolis, IN 46225; phone:<PHONE_NUMBER>; email<EMAIL_ADDRESS>Internet: www.rolls-royce.com. You may view this service
information at the FAA, Engine & Propeller Directorate, 12 New England
Executive Park, Burlington, MA. For information on the availability of
this material at the FAA, call<PHONE_NUMBER>.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2014-
0462, or in person at the Docket Management Facility between 9 a.m. and
5 p.m., Monday through Friday, except Federal holidays. The AD docket
contains this AD, the regulatory evaluation, any comments received, and
other information. The address for the Docket Office (phone: 800-647-
5527) is Document Management Facility, U.S. Department of
Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Kyri Zaroyiannis, Aerospace Engineer,
Chicago Aircraft Certification Office, Small Airplane Directorate, FAA,
2300 E. Devon Ave., Des Plaines, IL 60018; phone:<PHONE_NUMBER>; fax:
847-294-7834; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 by adding an AD that would apply to certain RRC AE 2100 series
turboprop engines and AE 3007A and 3007C series turbofan engines. The
NPRM published in the Federal Register on October 2, 2014 (79 FR

59461). The NPRM was prompted by reports of pitting in the wheel bores
and subsequent RRC analysis that concluded that lower life limits are
needed for the affected turbine wheels. The NPRM proposed to require
reducing the approved life limits of the affected turbine wheels and
performing an ECI of certain RRC engines with affected turbine wheels.
We are issuing this AD to prevent uncontained failure of the turbine
wheels, damage to the engine, and damage to the airplane.

Comments

    We gave the public the opportunity to participate in developing
this AD. We have considered the comment received. An anonymous
commenter supported the NPRM (79 FR 59461, October 2, 2014).

Conclusion

    We reviewed the relevant data, considered the comment received, and
determined that air safety and the public interest require adopting
this AD as proposed except for minor editorial changes, e.g., verb
tense changes and word changes appropriate to a final rule. We have
determined that these minor changes:
     Are consistent with the intent that was proposed in the
NPRM (79 FR 59461, October 2, 2014) for correcting the unsafe
condition; and
     Do not add any additional burden upon the public than was
already proposed in the NPRM (79 FR 59461, October 2, 2014).

Related Service Information

    We reviewed:
     Rolls-Royce (RR) Alert Service Bulletin (ASB) No. AE
2100D2-A-72-085, dated July 25, 2013.
     RR ASB No. AE 2100D3-A-72-277, dated July 25, 2013.
     RR ASB No. AE 2100P-A-72-019, dated July 25, 2013.
     RR ASB No. AE 3007A-A-72-407, Revision 1, dated August 29,
2014.
     RR ASB No. AE 3007A-A-72-408, Revision 1, dated August 29,
2014.
     RR ASB No. AE 3007C-A-72-316, dated December 6, 2013.
    These service bulletins describe procedures for inspecting high-
pressure turbine (HPT) stage 2 wheels and identify life-limit reduction
for all affected HPT wheels. You can find this information at http://www.regulations.gov by searching for and locating Docket No. FAA-2014-
0462.

Costs of Compliance

    We estimate that this AD will affect 664 engines installed on
airplanes of U.S. registry. We also estimate that it will take about 1
hour to perform an ECI in the bore of the turbine wheel for affected
engines. The average labor rate is $85 per hour. We estimate the pro-
rated replacement cost would be $30,688 for a 1st stage gas generator
turbine wheel; $63,693 for a HPT stage 1 wheel; $13,941 for an HPT
stage 2 wheel; and $13,186 for a 4th stage turbine wheel. We also
estimate that these parts would be replaced during an engine shop visit
at no additional labor cost. Based on these figures, we estimate the
total cost of this AD on U.S. operators to be $11,317,969.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. Subtitle VII: Aviation Programs,
describes in more detail the scope of the Agency's authority.
    We are issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701: ``General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    This AD will not have federalism implications under Executive Order
13132. This AD will not have a substantial direct effect on the States,
on the relationship between the national government and the States, or
on the distribution of power and responsibilities among the various
levels of government.
    For the reasons discussed above, I certify that this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Is not a ``significant rule'' under DOT Regulatory Policies and
Procedures (44 FR 11034, February 26, 1979),
    (3) Will not affect intrastate aviation in Alaska to the extent
that it justifies making a regulatory distinction, and
    (4) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

Adoption of the Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive (AD):

2015-02-08 Roll-Royce Corporation (Type Certificate previously held
by Allison Engine Company): Amendment 39-18075; Docket No. FAA-2014-
0462; Directorate Identifier 2014-NE-06-AD.

(a) Effective Date

    This AD is effective March 11, 2015.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to all Rolls-Royce Corporation (RRC) AE 2100D2,
2100D2A, 2100D3, and 2100P turboprop engines and AE 3007A1, A1/1,
A1/3, A1E, A1P, A2, A3, C, C1, and C2 turbofan engines:
    (1) With an installed 1st stage gas generator turbine wheel,
part number (P/N) 23079946, 23088906, or 23089692, all serial
numbers (S/Ns) listed in Table 2 and Table 3 of RRC Alert Service
Bulletin (ASB) No. AE 2100D2-A-72-085, dated July 25, 2013; and in
Table 2 and Table 3 of RRC ASB No. AE 2100D3-A-72-277, dated July
25, 2013.
    (2) With an installed high-pressure turbine (HPT) stage 1 or HPT
stage 2 wheel, P/N 23079946, 23088906, 23088784, 23084520, 23084781,
23088817, or 23088818, all S/Ns listed in Table 1 through Table 7 of
RRC ASB No. AE 3007A-A-72-407, Revision 1, dated August 29, 2014,
except those S/Ns excluded by Table 1, Table 2, Table 4, and Table 5
of RRC ASB No. AE 3007A-A-72-407, Revision 1, dated August 29, 2014.
    (3) With an installed HPT stage 2 wheel, P/N 23084520 or
23088818, all S/Ns listed in Table 1 and Table 2 of RRC ASB No. AE
3007C-A-72-316, dated December 6, 2013, except those S/Ns excluded
by Table 1 of RRC ASB No. AE 3007C-A-72-316, dated December 6, 2013.
    (4) With an installed 4th stage turbine wheel, P/N 23083536, all
S/Ns listed in Table 2 of RRC ASB No. AE 2100P-A-72-019, dated July
25, 2013.

(d) Unsafe Condition

    This AD was prompted by reports of pitting in the wheel bores
and subsequent RRC analysis that concluded that lower life

limits are needed for the affected turbine wheels. We are issuing
this AD to prevent uncontained failure of the turbine wheels, damage
to the engine, and damage to the airplane.

(e) Compliance

    Comply with this AD within the compliance times specified,
unless already done.
    (1) For all RRC AE 3007A1, A1/1, A1/3, A1E, A1P, and A3 series
engines with an HPT stage 2 wheel P/N and S/N identified in RRC ASB
No. AE 3007A-A-72-408, Revision 1, dated August 29, 2014, at each
shop visit after the effective date of this AD, eddy current inspect
the bore of the affected HPT stage 2 wheels. Use RRC ASB No. AE
3007A-A-72-408, Revision 1, August 29, 2014, to do the inspection.
Do not return to service any wheel that fails the inspection
required by this AD.
    (2) Thirty days after the effective date of this AD, do not
return to service any engine that has a turbine wheel with a P/N and
an S/N listed in any of the following RRC ASBs whose wheel life
exceeds the new life limits identified in the following RRC ASBs:
    (i) RRC ASB No. AE 2100D2-A-72-085, dated July 25, 2013;
    (ii) RRC ASB No. AE 2100D3-A-72-277, dated July 25, 2013;
    (iii) RRC ASB No. AE 2100P-A-72-019, dated July 25, 2013;
    (iv) RRC ASB No. AE 3007A-A-72-407, Revision 1, dated August 29,
2014; or
    (v) RRC ASB No. AE 3007C-A-72-316, dated December 6, 2013.

(f) Installation Prohibition

    Thirty days after the effective date of this AD, do not install
an affected wheel, as identified in paragraph (c) of this AD, into
any RRC AE 3007C2 engine.

(g) Definition

    For the purpose of this AD, an ``engine shop visit'' is the
induction of an engine into the shop for maintenance involving the
separation of pairs of major mating engine flanges, except that the
separation of engine flanges solely for the purposes of
transportation without subsequent engine maintenance is not an
engine shop visit.

(h) Alternative Methods of Compliance (AMOCs)

    The Manager, Chicago Aircraft Certification Office, FAA, may
approve AMOCs for this AD. Use the procedures found in 14 CFR 39.19
to make your request.

(i) Related Information

    For more information about this AD, contact Kyri Zaroyiannis,
Aerospace Engineer, Chicago Aircraft Certification Office, Small
Airplane Directorate, FAA, 2300 E. Devon Ave., Des Plaines, IL
60018; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>
(j) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless the AD specifies otherwise.
    (i) Rolls-Royce Alert Service Bulletin (ASB) No. AE 2100D2-A-72-
085, dated July 25, 2013.
    (ii) Rolls-Royce ASB No. AE 2100D3-A-72-277, dated July 25,
2013.
    (iii) Rolls-Royce ASB No. AE 2100P-A-72-019, dated July 25,
2013.
    (iv) Rolls-Royce ASB No. AE 3007A-A-72-407, Revision 1, dated
August 29, 2014.
    (v) Rolls-Royce ASB No. AE 3007A-A-72-408, Revision 1, dated
August 29, 2014.
    (vi) Rolls-Royce ASB No. AE 3007C-A-72-316, dated December 6,
2013.
    (3) For RRC service information identified in this AD, contact
Rolls-Royce Corporation, 450 South Meridian Street, Mail Code NB-01-
06, Indianapolis, IN 46225; phone:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>Internet: www.rolls-royce.com.
    (4) You may view this service information at FAA, Engine &
Propeller Directorate, 12 New England Executive Park, Burlington,
MA. For information on the availability of this material at the FAA,
call<PHONE_NUMBER>.
    (5) You may view this service information at the National
Archives and Records Administration (NARA). For information on the
availability of this material at NARA, call<PHONE_NUMBER>, or go to:
http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Burlington, Massachusetts, on January 13, 2015.
Thomas A. Boudreau,
Acting Directorate Manager, Engine & Propeller Directorate, Aircraft
Certification Service.
[FR Doc. 2015-01282 Filed 2-3-15; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 86, Number 4 (Thursday, January 7, 2021)]
[Notices]
[Pages 1103-1104]
[FR Doc No: 2020-29324]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #1

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

    Docket Numbers: ER10-1338-004.
    Applicants: Southern Indiana Gas and Electric Company, Inc.
    Description: Triennial Market Power Analysis for Central Region of
Southern Indiana Gas and Electric Company, Inc.
    Filed Date: 12/30/20.
    Accession Number: 20201230-5360.
    Comments Due: 5 p.m. ET 3/1/21.

    Docket Numbers: ER10-2127-020.
    Applicants: Invenergy TN LLC.
    Description: Triennial Market Power Analysis for Southeast Region
of Invenergy TN LLC.
    Filed Date: 12/31/20.
    Accession Number: 20201231-5035.
    Comments Due: 5 p.m. ET 3/2/21.

    Docket Numbers: ER10-2134-013.
    Applicants: Hardee Power Partners Limited.
    Description: Triennial Market Power Analysis for Southeast Region
of Hardee Power Partners Limited.
    Filed Date: 12/31/20.
    Accession Number: 20201231-5034.
    Comments Due: 5 p.m. ET 3/2/21.

    Docket Numbers: ER10-2877-003.
    Applicants: Cobb Electric Membership Corporation.
    Description: Triennial Market Power Analysis for Southeast Region
of Cobb Electric Membership Corporation.
    Filed Date: 12/30/20.
    Accession Number: 20201230-5258.
    Comments Due: 5 p.m. ET 3/1/21.

    Docket Numbers: ER10-3079-018.
    Applicants: Tyr Energy, LLC.
    Description: Triennial Market Power Analysis for Southeast Region
of Tyr Energy, LLC.
    Filed Date: 12/30/20.
    Accession Number: 20201230-5359.
    Comments Due: 5 p.m. ET 3/1/21.

    Docket Numbers: ER10-3109-013.
    Applicants: Washington County Power, LLC.
    Description: Triennial Market Power Analysis for Southeast Region
of Washington County Power, LLC.
    Filed Date: 12/30/20.
    Accession Number: 20201230-5371.
    Comments Due: 5 p.m. ET 3/1/21.

    Docket Numbers: ER12-637-006.
    Applicants: Calhoun Power Company, LLC.
    Description: Triennial Market Power Analysis for Southeast Region
of Calhoun Power Company, LLC.
    Filed Date: 12/30/20.
    Accession Number: 20201230-5358.
    Comments Due: 5 p.m. ET 3/1/21.

    Docket Numbers: ER17-615-004; ER10-2184-028; ER10-2192-036; ER10-
2178-036; ER11-2014-026; ER11-2013-026; ER13-1536-020; ER11-2005-026.
    Applicants: Albany Green Energy, LLC, CER Generation, LLC,
Constellation Energy Commodities Group Maine, LLC, Constellation
NewEnergy, Inc., Cow Branch Wind Power, LLC, CR Clearing, LLC, Exelon
Generation Company, LLC, Wind Capital Holdings, LLC.
    Description: Triennial Market Power Analysis for Southeast Region
of Exelon Southeast MBR Entities.
    Filed Date: 12/30/20.
    Accession Number: 20201230-5242.
    Comments Due: 5 p.m. ET 3/1/21.

    Docket Numbers: ER20-1505-002.
    Applicants: Basin Electric Power Cooperative.
    Description: Triennial Market Power Analysis for Central Region of
Basin Electric Power Cooperative.
    Filed Date: 12/30/20.
    Accession Number: 20201230-5229.
    Comments Due: 5 p.m. ET 3/1/21.

    Docket Numbers: ER21-251-001.
    Applicants: Degrees3 Transportation Solutions, LLC.

    Description: Tariff Amendment: Amendment to 1 to be effective 10/
30/2020.
    Filed Date: 12/31/20.
    Accession Number: 20201231-5017.
    Comments Due: 5 p.m. ET 1/21/21.

    Docket Numbers: ER21-775-000.
    Applicants: NorthWestern Corporation.
    Description: Sec.  205(d) Rate Filing: SA 305 16th Rev--NITSA with
Stillwater Mining Company to be effective 3/1/2021.
    Filed Date: 12/30/20.
    Accession Number: 20201230-5220.
    Comments Due: 5 p.m. ET 1/21/21.

    Docket Numbers: ER21-776-000.
    Applicants: East Coast Power and Gas, LLC.
    Description: Tariff Cancellation: Cancellation Filing to be
effective 12/31/2020.
    Filed Date: 12/31/20.
    Accession Number: 20201231-5000.
    Comments Due: 5 p.m. ET 1/21/21.

    Docket Numbers: ER21-777-000.
    Applicants: NSTAR Electric Company.
    Description: Sec.  205(d) Rate Filing: Large Generator
Interconnection Agreement -MMWEC, Stony Brook?Ludlow to be effective
12/31/2020.
    Filed Date: 12/31/20.
    Accession Number: 20201231-5002.
    Comments Due: 5 p.m. ET 1/21/21.

    Docket Numbers: ER21-778-000.
    Applicants: Niagara Mohawk Power Corporation, New York Independent
System Operator, Inc.
    Description: Sec.  205(d) Rate Filing: Reimbursement Agreement (SA
2590) between NMPC and NY Transco to be effective 12/11/2020.
    Filed Date: 12/31/20.
    Accession Number: 20201231-5004.
    Comments Due: 5 p.m. ET 1/21/21.

    Docket Numbers: ER21-779-000.
    Applicants: NorthWestern Corporation.
    Description: Compliance filing: Order No. 864 Compliance Filing
(Montana OATT) to be effective 1/27/2020.
    Filed Date: 12/31/20.
    Accession Number: 20201231-5011.
    Comments Due: 5 p.m. ET 1/21/21.

    Docket Numbers: ER21-780-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: Original ISA, SA No. 5863;
Queue No. AE2-249 to be effective 12/3/2020.
    Filed Date: 12/31/20.
    Accession Number: 20201231-5016.
    Comments Due: 5 p.m. ET 1/21/21.

    Docket Numbers: ER21-781-000.
    Applicants: Duke Energy Carolinas, LLC.
    Description: Sec.  205(d) Rate Filing: Revisions to Rate Schedule
Nos. 315, 316, 317, and 335 to be effective 1/1/2021.
    Filed Date: 12/31/20.
    Accession Number: 20201231-5020.
    Comments Due: 5 p.m. ET 1/21/21.

    Docket Numbers: ER21-782-000.
    Applicants: ISO New England Inc., New England Power Pool
Participants Committee.
    Description: Sec.  205(d) Rate Filing: ISO-NE & NEPOOL; Change to
Implement New Methodology for Calculating FCM DDBT to be effective 3/2/
2021.
    Filed Date: 12/31/20.
    Accession Number: 20201231-5026.
    Comments Due: 5 p.m. ET 1/21/21.

    Docket Numbers: ER21-783-000.
    Applicants: Southwest Power Pool, Inc.
    Description: Sec.  205(d) Rate Filing: 3330R3 City of Nixa,
Missouri to be effective 12/1/2020.
    Filed Date: 12/31/20.
    Accession Number: 20201231-5032.
    Comments Due: 5 p.m. ET 1/21/21.

    Docket Numbers: ER21-784-000.
    Applicants: New York State Electric & Gas Corporation.
    Description: Sec.  205(d) Rate Filing: Revisions to 2020 Facilities
Agreement Update to be effective 1/1/2021.
    Filed Date: 12/31/20.
    Accession Number: 20201231-5033.
    Comments Due: 5 p.m. ET 1/21/21.

    Docket Numbers: ER21-785-000.
    Applicants: Southwest Power Pool, Inc.
    Description: Sec.  205(d) Rate Filing: 3751 NorthWestern Energy
NITSA and NOA to be effective 12/1/2020.
    Filed Date: 12/31/20.
    Accession Number: 20201231-5037.
    Comments Due: 5 p.m. ET 1/21/21.

    Docket Numbers: ER21-786-000.
    Applicants: Trans Bay Cable LLC.
    Description: Sec.  205(d) Rate Filing: Annual TRBAA Filing--2020 to
be effective 1/1/2021.
    Filed Date: 12/31/20.
    Accession Number: 20201231-5038.
    Comments Due: 5 p.m. ET 1/21/21.

    Docket Numbers: ER21-787-000.
    Applicants: ISO New England Inc.
    Description: Sec.  205(d) Rate Filing: ISO-NE; Updates to CONE, Net
CONE, and Capacity Performance Payment Rate to be effective 3/2/2021.
    Filed Date: 12/31/20.
    Accession Number: 20201231-5060.
    Comments Due: 5 p.m. ET 1/21/21.

    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: December 31, 2020.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2020-29324 Filed 1-6-21; 8:45 am]
BILLING CODE 6717-01-P