Notice of Filing of Pesticide Petition 8E7353

IR-4 Project Headquarters

EPA Registration Division contact: Susan Stanton<PHONE_NUMBER>

EPA has received a pesticide petition (PP #8E7353) from IR-4 Project
Headquarters, 500 College Road East, Suite 201W, Princeton, NJ 08540,
proposing, pursuant to section 408(d) of the Federal Food, Drug, and
Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part 180.518 by
establishing tolerances for residues of the fungicide pyrimethanil
4,6-dimethyl-N-phenyl-2-pyrimidinamine in or on the raw agricultural
commodities as follows 1) revise the existing tolerance for the fruit,
stone, group 12, except cherry at 3.0 parts per million (ppm) to fruit,
stone, group 12 at 10 ppm, 2) revise the tolerance designation for
fruit, citrus, group 10 postharvest to exclude lemons at 10 ppm to read
fruit, citrus, group 10, except lemons (postharvest) at 10 ppm  and 3)
add a separate tolerance for lemon at 11.0 ppm. EPA has determined that
the petition contains data or information regarding the elements set
forth in section 408(d)(2) of the FFDCA; however, EPA has not fully
evaluated the sufficiency of the submitted data at this time or whether
the data supports granting of the petition.  Additional data may be
needed before EPA rules on the petition.

A. Residue Chemistry

	1. Plant metabolism. The metabolic profile of pyrimethanil has been
investigated following application to five different crops (apple,
carrots, grapes, lettuce and tomatoes) and is well understood.  In
plants, pyrimethanil is the only significant residue ranging from
essentially all of the Total Radioactive Residues (TRR) in carrots and
tomatoes to 44% in lettuce. Limited metabolism of pyrimethanil occurs
with minor amounts (less than 10%) of the phenyl and pyrimidyl
hydroxylated metabolites (AE C614276, AE C614277, AE C614278 and AE
C621312) being released after acid hydrolysis. Analysis of the foliage
from apples and carrots confirmed that the metabolism of pyrimethanil in
plants proceeded primarily via hydroxylation of the aromatic ring
structures as well as the methyl groups.

	2. Analytical method.  The plant metabolism studies indicated that
analysis for the parent compound, pyrimethanil was sufficient to enable
the assessment of the relevant residues in crop commodities.  For the
stone fruit group, peaches, plums, and sweet cherries were analyzed as
representative crops.  For peaches, plums, and sweet cherries
pyrimethanil was extracted by homogenization with acetone, the extract
acidified and washed with hexane and basified to enable solvent
partition  (ethyl acetate and hexane).  Final clean up was by silica
SPE, with determination by gas chromatography with mass selective
detection.  The validated sensitivity of the method is 0.05 ppm for
pyrimethanil, which allows for the detection and measurement of residues
in or on stone fruits at or above the proposed tolerance level.

	3. Magnitude of residues. Magnitude of residue trials were conducted
for pyrimethanil applied postharvest to peaches, plums, and cherries by
whole fruit dip, and high volume sprays and to peaches and plums by low
volume sprays. Three (3) peach field trials were conducted during the
2004 and 2005 growing seasons, two in California (Region 10) and one in
New Jersey (Region 2).  Likewise, three (3) plum field trials were
conducted during the 2004 growing season, one each in California,
Washington (region 11) and Michigan (Region 5).  California represents
54% of the U.S. fresh (freestone) peach production and over 90% of the
US plum production.  U.S. cherry trials (3) were conducted in 2006 in
California, Michigan, and Washington.  Additional trials were conducted
in Germany with fruits originating from Chile and Argentina.  Samples
were harvested at maturity and analyzed with the validated analytical
method described above.

In each U.S. trial, the stone fruits were dipped for approximately 30
seconds in the fungicide solution at a rate of approximately 0.881 lb ai
/100 gal mix (equivalent to 400 g ai/100 gal or 1000 ppm AI).  Two
additional treatments were examined in the California trials and
Washington cherry trials, whereby fruit were sprayed with PENBOTEC™
400SC at a rate of approximately 400 grams AI/200,000 lb fruit (400
grams AI/25,000 lbs fruit for cherries) in a high-volume or low-volume
spray, except for cherries where a low volume application was not
conducted.   A fruit wax adjuvant was added to each of the mixtures for
all treatments.  In the foreign trials, fruit were dipped for 30-60
seconds in aqueous solutions containing either 323 or 430 ppm
pyrimethanil,and sampled for residues after 0, 3, 7, 14, 28, 31, 35, and
42 days in cold or ambient storage. Following treatment, the fruits were
allowed to dry and the pits were removed prior to frozen storage until
analysis.

The results from the three peach trials show that the maximum residue in
fruit following a 30-second post-harvest dip in PENBOTEC 400SC at
approximately 0.881 lb ai/100 gal mix was 8.2 ppm.  Residues were
lower in samples treated with the low-volume spray (400 g ai/16.42 gal
oil and water mixture) of PENBOTEC 400SC at approximately 400 grams
AI/200,000 lb fruit, with a maximum residue of 3.3 ppm.  The lowest
residues were observed in samples treated with the high-volume spray
(400 g ai/~ 100 gal oil and water mixture) of PENBOTEC 400SC at
approximately 400 grams AI/200,000 lb fruit, with a maximum residue of
2.1 ppm.

On plums, the results from the three trials show that the maximum fruit
residue following a 30-second post-harvest dip in PENBOTEC 400SC at
approximately 0.881 lb ai/100 gal mix was 2.00 ppm.  Residues were
lower in samples treated with the low-volume spray (400 g ai/16.42 gal
oil and water mixture) of PENBOTEC 400SC at approximately 400 grams
AI/200,000 lb fruit, with a maximum residue of 0.347 ppm.  The lowest
residues were observed in samples treated with the high-volume spray
(400 g ai/~ 100 gal oil and water mixture) of PENBOTEC 400SC at
approximately 400 grams AI/200,000 lb fruit, with a maximum residue of
0.204 ppm.

On sweet cherries, the results from the three U.S trials show that the
maximum fruit residue following a 30-second post-harvest dip in PENBOTEC
400SC at approximately 0.881 lb ai/100 gal mix was 13.00 ppm.
Residues were about the same in samples treated with the high-volume
spray (400 g ai/~ 100 gal oil and water mixture) of PENBOTEC 400SC at
approximately 400 grams AI/25,000 lb fruit, with a maximum residue of
12.0 ppm.  In the foreign trials, fruit dipped at 323 or 430 ppm AI had
maximum residues of 1.21 ppm and 1.47 ppm, respectively.

Since the registrant is proposing a maximum application rate that is
half the rate tested (i.e. 500 ppm vs 1000 ppm for dip treatment), the
data were extrapolated and the MRL calculator used to project a proposed
tolerance level.  When the MRL calculator rejects lognormality, it
recommends the California Method of the mean plus three standard
deviations.  The resulting recommendation for the stone fruit crop group
is 7 ppm for postharvest use.  Since there is already an existing
tolerance of 3.0 ppm for the stone fruit crop group (except cherries), a
revised tolerance of 10.0 ppm for the entire Crop Group 12 – Stone
Fruits is proposed.

Five lemon trials were conducted in California, representing NAFTA
growing region 10.  At each trial, one foliar airblast application of
Scala 600SC at a rate of approximately 0.70 lb ai/A was applied.  No
adjuvant was added to the spray mixtures.  Commercially mature lemons
were collected 7 days prior to harvest.  The maximum storage interval
for field-treated samples in this study was 523 days.  Storage
stability testing was performed after 542 days of frozen storage;
results demonstrated stability.  Pyrimethanil residues ranged from 0.068
to 0.31 ppm with the lowest residues (0.068 ppm and 0.095 ppm) in a
single trial, while in the remaining trials, residues ranged from 0.12
to 0.31 ppm, and the highest average field trial was 0.27 ppm.

B. Toxicological Profile

	1. Acute toxicity.  Pyrimethanil is of low acute toxicity placing the
active ingredient in Toxicity Category II, III and IV.  Pyrimethanil is
non-irritating to the eyes and skin and is not a skin sensitizer.

	2. Genotoxicity. Pyrimethanil is not mutagenic or genotoxic in any
assay in either the presence or absence of metabolic activation.

	3. Reproductive and developmental toxicity. Pyrimethanil is not a
developmental or reproductive toxicant.

a.  Teratology - Rat

Thirty Sprague Dawley rats/group received doses of 0, 7, 85, 1,000 mg/kg
of pyrimethanil by gavage from gestation days (GD) 6-15.  At the highest
dose tested, reduced maternal body weight gain was observed during
GD6-15, along with a slight but statistically significant decrease in
food consumption, hair loss, hunched posture, slight emaciation, and
slightly reduced mean fetal body weight.  The maternal and developmental
NOEL was 85 mg/kg.

b.  Teratology - Rabbit

Groups of at least 18 time-mated New Zealand White rabbits received oral
gavage doses of 0, 7, 45 or 300 mg/kg/d pyrimethanil over gestation days
(GD) 7-19.  At the highest dose tested, there was a decrease in body
weight gain, production of feces and food consumption.  Three females
were euthanized due to severe emaciation.  The highest dose, 300
mg/kg/day exceeded the maternal maximum tolerated dose (MTD).  The
maternal NOAEL was 45 mg/kg/d due to reduced fecal production in 1/3 of
the animals. The high dose resulted in reduced mean fetal body weight,
increased incidence of runts, delayed skeletal ossification and
incidence of fetuses with 13 thoracic vertebrae and ribs. The maternal
NOEL was 7 mg/kg/day.  The developmental NOEL was 45 mg/kg/d.

c.  Two-Generation Reproduction - Rat

Three groups of 30 Sprague-Dawley rats per sex received dietary exposure
to pyrimethanil at levels of 0, 1.7, 20.9 or 266.7 mg/kg/d.  In the
parental generation at the highest dose tested there was a statistically
significant decrease in mean body weight gain in both sexes.  Mean pup
weights, observed on PND1 through weaning, were reduced, though were
within the range of historical controls.  In the F1 generation at the
highest dose tested, mean body weights and mean food consumption were
reduced.  Though the mean score for the combined sexes was the same as
the controls, a marginally different air-righting reflex at PND11
associated with reduced body weight was seen in high dose male pups.
The NOEL for maternal and developmental toxicity was 20.9 mg/kg/d.  The
reproductive NOEL was 266.7 mg/kg/d.

	4. Subchronic toxicity.

28-Day Dietary – Rat

Five Sprague-Dawley rats/sex/group received dietary exposure to
pyrimethanil for 28 days at 0, 844, 1,161, 1,500 and 2,710 mg/kg/day.
All doses exceeded the maximum tolerated dose.  Severe emaciation was
observed at all dose levels.  Body weight gains and food consumption
were reduced.  Liver and thyroid histopathology were observed, along
with reduced hemoglobin, MCV and MCH.  Kidney, adrenal and liver weights
were altered.  No NOEL or NOAEL was achieved.

90 Day Dietary – Rat

Ten Sprague-Dawley rats/sex/group received pyrimethanil in the diet at
dose levels of 0, 5.4-6.8, 54.5-66.7, 545-667 mg/kg/d (males and
females, respectively).  High dose animals had reduced body weight gain
and food consumption, increased urinary protein in males, colored urine
(not blood or bilirubin) and minimal hepatocellular hypertrophy.  The
NOAEL in males was 54.5-66.7 (males and females, respectively) due to
colored urine and a low incidence of minimal centrilobular
hepatocellular hypertrophy.  The NOEL was 5.4 mg/kg/d (males) -6.8
mg/kg/d  (females).

28-Day Dietary-Mouse

Five CD-1 mice/sex/group received dietary doses of 0, 167-236, 567-667,
1960-2357 mg/kg/d, males and females respectively, for 28 days (all the
mice in one additional high dose group, 30,000 ppm, died within the
first week of the study).  At  1960-2357 mg/kg/day, animals experienced:
 body weight loss (females), decreased body weight gain during the 1st
two weeks (males), a statistically significant decrease in cholesterol,
statistically significant decreases in relative liver weights (females),
pigmentation of thyroid follicles, urolithiasis, moderate urothelial
hyperplasia in urinary bladder, and slight kidney tubular degeneration
(females).  The NOEL was 167-236 mg/kg/d.

90-Day Dietary-Mouse

Twenty CD-1 mice/sex/group received pyrimethanil diet exposure at dose
levels of 0, 12-18, 139-203, 1,864-2,545 mg/kg/d males-females for 90
days.  At the high dose, animals had decreased body weight and increased
food consumption, cholesterol and total bilirubin.  High dose females
had increased relative liver weights.  Histopathology in the high dose
animals was found in the kidneys, liver, thyroid, and urinary bladder.
High dose males had slight urinary tract tubular dilation and slight to
moderate hyperplasia of bladder epithelium.  The NOEL was determined to
be 12 mg/kg/d (males) -18 mg/kg/d (females).  Based on mild hepatic
glycogen depletion, the NOAEL was 139-203 mg/kg/d (males and females,
respectively).

90-Day Dietary-Dog

Four beagle dogs/sex/group received pyrimethanil by gavage for 90 days
at doses of 0, 6, 80, 1,000 mg/kg/d.  The high dose was lowered to 800
mg/kg/d on day 7 due to frequent and consistent vomiting.  Decreased
body weight, food and water consumption were observed.  Males had a
significant reduction in phosphate, while females experienced a slight
reduction in sodium, anion gap and total protein.  At 80 mg/kg/day,
infrequent vomiting after dosing and decreased water consumption were
observed.  After 4 weeks of dosing at 80 mg/kg/day, males had
significantly reduced phosphate.  The NOAEL was 80 mg/kg/day.  The NOEL
was 6 mg/kg/day.

f.   Dermal Toxicity Evaluation

No dermal studies have been conducted for pyrimethanil.

	5. Chronic toxicity

a.  Chronic Toxicity - Dog

Four beagle dogs/sex/group received pyrimethanil by gavage at levels of
0, 2, 30, or 250 mg/kg/day for twelve months.  The high dose was reduced
from 400 to 250 mg/kg/day on day 8 of treatment due to excessive
vomiting during the first week of treatment. At the high dose, there was
a decrease in mean body weight gain and mean consumption of food and
water.  The NOEL for the study was 30 mg/kg/day, with the high dose of
250 mg/kg/day being the NOAEL.

b.  Combined Chronic Toxicity / Oncogenicity - Rat

Seventy Sprague-Dawley rats/sex/group received pyrimethanil by diet at
levels of 0, 1.3-1.8, 17-22, 221-291 mg/kg/day (males and females,
respectively) for two years.  At the highest dose tested, body weight
gain and food consumption were decreased.  Absolute liver weights were
increased.  Histopathology revealed centrilobular hepatocyte
hypertrophy, increased incidence of eosinophilic foci (males), thyroid
follicular hyperplasia, hypertrophy and colloid depletion, and the
presence of a brown pigment, identified as lipofuscin in thyroid
follicular cell epithelium.  There was a statistically significant,
dose-dependent increase in the incidence of benign thyroid follicular
cell adenomas.  There was no increased incidence in any malignant tumor
or increase in tumor multiplicity as a result of daily dietary ingestion
of pyrimethanil at any dose level.  The results of special studies,
discussed below, demonstrate that the benign thyroid tumors are likely a
secondary result of a disruption of thyroid-pituitary homeostasis, a
well-known, threshold-mediated mechanism.  The NOEL was 17 mg/kg/d
(males) and 22 mg/kg/day (females).

c.  Oncogenicity - Mouse

Fifty-one CD-1 mice/sex/group received pyrimethanil by diet at 0, 16,
160 and 1,600 ppm (corresponding to 0, 2-2.5, 20-24.9, 210.9-253.8
mg/kg/day in males and females, respectively).  There was an increase in
the number of high dose male deaths caused by urogenital tract lesions.
Urinary bladder histopathology on those dying during the course of the
study indicates an increase in the incidence of male urinary bladder
distension, cystitis, urothelial hyperplasia and inflammation of the
penis.  These findings are consistent with the findings of both the 28-
and 90-day studies indicating that high dose administration of
pyrimethanil resulted in urolith formation leading to irritation,
distension and hyperplasia of the urinary bladder and urinary tract.
Chronic dietary treatment with pyrimethanil produced no increased
incidence of tumor-bearing mice nor of any specific tumor type
suggestive of a carcinogenic effect. The NOEL for both sexes was 20-24.9
mg/kg/d (males and females, respectively).

d.  Special Studies

Since rodent thyroid tumors are fairly common, and since the EPA has
established that five lines of evidence are required to prove the
thyroid-pituitary disruption mode of action for rodent thyroid tumors,
special studies were undertaken

Thyroid mechanistic study (14-Day)

Sprague Dawley rats received 378.5 mg/kg/d of pyrimethanil for 14 days
to study the effects of pyrimethanil on the thyroid and liver microsomal
enzymes.  An increase in the levels of UDPGT and a corresponding
statistically significant increase in liver weight were observed.
Thyroid hormones T4 and T3 were decreased, while TSH levels were
significantly increased.  All effects were shown to be reversible.

Dietary Thyroid Function Test Using Perchlorate Discharge (7-Day)

Sprague Dawley rats received 509 mg/kg/d pyrimethanil or 177 mg/kg/d
propylthiouracil, or 109 mg/kg/d phenobarbital in order to study the
function of the thyroid gland.  The animals fed pyrimethanil had 43%
decreased body weight gain, 21% decreased food consumption and a 150%
increase in uptake of iodine-125.  There was no significant discharge of
radioactive iodine from the thyroid after administration of perchlorate.

The required five lines of evidence to support the threshold mode of
action for thyroid pituitary disruption and rat thyroid tumors are
satisfied in the pyrimethanil studies.

The EPA’s final rule establishing a tolerance for pyrimethanil in wine
stated that “The Agency’s Carcinogenicity Peer Review Committee
(CPRC) chose a non-linear approach (MOE) based on a NOEL of 17 mg/kg/day
for increased incidences of thyroid tumors in rats.  The MOE methodology
was selected because of thyroid tumors associated with administration of
pyrimethanil in the rat, which may be due to a disruption in the
thyroid-pituitary status.  This chemical has been classified as a Group
C chemical (possible human carcinogen) and a non-linear methodology
(MOE) was applied for the estimation of human cancer risk. The estimated
MOE does not exceed the Agency’s level of concern and therefore, EPA
has a reasonable certainty that no harm will result from exposures to
residues of pyrimethanil.”

	6. Neurotoxicity.

a.  Acute Neurotoxicity

Groups of 10 rats/sex/group were dosed once by oral gavage at dose
levels of  0, 30, 100, 1,000 mg of pyrimethanil/kg bodyweight.  On the
day of dosing, high dose animals experienced transient behavioral
effects attributable to receipt of a substantial bolus dose of test
substance.  No histopathological lesions accompanied these transient
behavioral changes.  The NOAEL was 100 mg/kg due to reduced body
temperature for males.  The NOEL was 30 mg/kg.

b.  Subchronic Neurotoxicity

Groups of 12 Sprague-Dawley rats per sex were treated for 13 weeks with
pyrimethanil via the diet  at 0, 4, 38.7-44.3, 391.9-429.9 mg/kg/d
(males and females, respectively).  There were no treatment-related
findings in behavioral assessments, neuropathology or brain
morphometrics.  The NOEL for this study is 38.7 – 44.3 mg/kg/day
(males and females, respectively) based upon decreased body weight and
food consumption in the high dose group.

	6. Animal metabolism. Pyrimethanil is rapidly metabolized and excreted
from lactating dairy cows.  The observed total radioactive residues in
edible tissues and milk were as follows: milk - maximum residue of 0.069
ppm; liver -0.363 ppm; kidney – 0.249 ppm and muscle – 0.017 ppm.
The metabolic pathway is similar to that of plants involving
hydroxylation of the phenyl and pyrimidine rings as well as
hydroxylation of the methyl substituents.  Further metabolic reactions
occur including cleavage of the phenyl ring to produce substituted
pyrimidines.  The major metabolite was AE C614276 (46% of the kidney
residues, 63% of the milk residues) resulting from hydroxylation of the
phenyl ring.  Hydroxylation of the pyrimidinyl ring of pyrimethanil
resulted in formation of minor amounts of AE C614277.  Hydroxylation of
the methyl groups of pyrimethanil resulted in formation of minor amounts
of AE C614278.  Hydroxylation of the methyl groups of AE C614276
resulted in formation of minor amounts of AE C614800.

7. Endocrine disruption. Chronic, life span, and multi-generational
bioassays in mammals and acute and subchronic studies on aquatic
organisms and wildlife did not reveal endocrine effects.  Any endocrine
related effects would have been detected in this definitive array of
required tests.  The probability of any such effect due to agricultural
uses of pyrimethanil is negligible.

C. Aggregate Exposure

effects.  Any endocrine related effects would have been detected in this
definitive array of required tests.  The probability of any such effect
due to agricultural uses of pyrimethanil is negligible.

	1. Dietary exposure.  An increase in the pyrimethanil tolerance under
40 CFR §180.518 is proposed for the stone fruit crop group 12 to allow
for post-harvest application. Tolerances are currently established for
the residues of the fungicide pyrimethanil in or on the following raw
agricultural commodities: almond (0.2 ppm), almond hulls (12 ppm), apple
wet pomace (12 ppm), banana (0.1 ppm), citrus oil (150 ppm), citrus
fruit crop group 10 – postharvest (10 ppm), pome fruit crop group 11
– preharvest and postharvest (3 ppm), stone fruit (except cherry) crop
group 12 (3 ppm), grape (5 ppm), grape, raisin (8 ppm), onion, dry bulb
(0.1 ppm), onion, green (2 ppm), pistachio (0.2 ppm), strawberry (3
ppm), tomato (0.5 ppm), and vegetable, tuberous and corm subgroup 1C
(0.05 ppm).  Tolerances are also established for the combined residues
of pyrimethanil and its metabolite 4-[4,6-dimethyl-2-pyrimidinyl) amino]
phenol in or on fat, meat, meat by-products (except kidney) of cattle,
goat, horse, and sheep (0.01 ppm) and kidney of cattle, goat, horse, and
sheep (0.3 ppm), and of the combined residues of pyrimethanil and the
metabolite 4,6-dimethyl-2-(phenylamino)-5-pyrimidinol in or on milk
(0.03 ppm).   There are no residential uses proposed for pyrimethanil.
Therefore, potential human risk scenarios cover aggregate exposure from
food residues and drinking water.

	i. Food  and drinking water

Estimates of acute dietary exposure from potential pyrimethanil residues
with the addition of postharvest uses on stone fruits are all well under
100% of the acute reference dose at the 95th percentile.   This assumed
all commodities contained tolerance level residue concentrations, 100%
crop treated, and all consumed water at the highest EEC.  The highest
exposed subpopulation of children 1-2 years old utilizes 64.0% of the
reference dose (aRfD), while females aged 13-49 years old utilize 22% of
the acute population adjusted dose (aPAD).  These potential dietary
exposures were assessed based on the Dietary Exposure Evaluation Model
– Food Consumption Database (DEEM-FCID, ver 1.30) and Lifeline (ver.
2.00) models.

Chronic dietary exposure estimates resulting from the proposed uses of
pyrimethanil are well within acceptable limits for all population
subgroups examined.  This assumes all commodities contained average
field trial residue concentrations, 100% crop treated, combined mean
residue concentrations as modeled, high-end pome fruit residues, and all
consumed water at the highest EEC.  The highest exposed subpopulation
was Non-nursing infants; at the chronic cRfD of 0.17 mg/kg body weight
(BW), exposure occupied 18% of the cRfD.  The U.S. Population (total)
exposure was 0.005624 mg/kg BW, with a margin of exposure (MOE) of
3,023.

US EPA’s Standard Operating Procedure (SOP) for Drinking Water
Exposure and Risk Assessments was followed to perform the Tier One
drinking water assessment.  This SOP uses a variety of tools to conduct
drinking water assessments, including water models such as SCI-GROW,
FIRST, PRZMS/EXAMS, and monitoring data.  If monitoring data are not
available then the models are used to predict potential residues in
surface and ground water and the highest levels (whether ground or
surface) are assumed to be the drinking water residue.  In the case of
pyrimethanil, monitoring data are not available.  SCI-GROW and FIRST
were used to estimate a drinking water residue.  Calculation of the
Drinking Water Estimated Concentration (DWEC) for surface water for the
worst-case pyrimethnail use scenario results in a acute DWEC of 122 ppb
and a chronic DWEC of 37 ppb.  DWLOCs calculated based on the acute and
chronic risk assessments described above are many fold higher than these
conservative DWECs.  The adult acute and chronic DWLOCs are 9,860 ppb
and 5,936 ppb respectively.  Children’s acute and chronic DWLOCs are
2,641ppb and 1,686 ppb respectively.

	2. Non-dietary exposure. Pyrimethanil products are not labeled for
residential uses (food or non-food), thereby eliminating the potential
for residential exposure or non-occupational exposure.

D. Cumulative Effects  Section 408(b)(2)(D)(v) requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider “available information” concerning the cumulative
effects of a particular pesticide’s residues and “other substances
that have a common mechanism of toxicity.” There are no available data
to determine whether pyrimethanil has a common mechanism of toxicity
with other substances or how to include this pesticide in a cumulative
risk assessment.  Unlike other pesticides for which EPA has followed a
cumulative risk approach based on a common mechanism of toxicity,
pyrimethanil does not appear to form a toxic metabolite produced by
other substances.  For the purposes of the tolerance petition and this
reduced risk rationale, therefore, it has been assumed that pyrimethanil
does not have a common mechanism of toxicity with other substances.

E. Safety Determination

	1. U.S. population.

Using the assumptions and data described above, based on the
completeness and reliability of the toxicity data, it is concluded that
dietary risk from the proposed uses of pyrimethanil are acceptable for
all populations examined.  Chronic exposure for the US Population
utilizes 3.3% (0.005624 mg/kg bw/day) of the chronic reference dose.
The most highly exposed population of non-nursing infants utilizes 18%
of the chronic reference dose and the most highly exposed population of
children 1-2 years old utilizes 64% of the acute reference dose.  The
actual exposures are likely to be much less as more realistic data and
models are developed.  EPA generally has no concern for exposures below
100% of the RfD (acute or chronic), because the RfD represents the level
at or below which exposure will not pose appreciable risk to human
health.  Drinking Water Levels of Comparison (DWLOC) for adults both
acute (9,860 ppb) and chronic (5,936 ppb) are several orders of
magnitude above the conservative Drinking Water Estimated Concentration
(DWEC) for acute (122 ppb) and chronic (37 ppb) worst case scenarios.
Therefore there is a reasonable certainty that no harm will occur to the
US Population from aggregate exposure (food and drinking water) to
residues of pyrimethanil.

	2. Infants and children.

The relevant toxicity studies as discussed in the toxicology section
above show no extra sensitivity of infants and children to pyrimethanil,
therefore, the FQPA safety factor can be removed.  Using the assumptions
and data described in the exposure section above, it is concluded that
dietary risk from the proposed uses of pyrimethanil are acceptable for
all infant and children sub-populations examined.  The most highly
exposed sub-populations were Non-nursing infants for chronic analysis,
and children 1-2 years old for acute analyses.  The sub-population
Non-nursing infants, utilizes 18% (0.030240 mg/kg bw/day) of the chronic
reference dose and the sub-population of children 1-2 years old utilizes
64% of the acute reference dose.  All other infant and children
populations have less exposure.   The chronic and acute drinking water
levels of concern for children (1,684 ppb and 2,600 ppb respectively)
are well above the conservative drinking water estimated concentrations
for chronic and acute scenarios.  The chronic DWEC is 37 ppb and the
acute DWEC is 122 ppb.  Therefore, there is a reasonable certainty that
no harm will occur to infants and children from aggregate exposure to
residues of pyrimethanil.

F. International Tolerances  Maximum Residue Limits (Codex MRLs) for
pyrimethanil have not been established by the Codex Alimentarius
Commission.

 62 Federal Register 63662-63669 (December 2, 1997)

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[Federal Register: November 3, 2008 (Volume 73, Number 213)]
[Notices]
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October 28, 2008.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on October 21, 2008, BATS Exchange, Inc. (``BATS'' or ``Exchange'')
filed with the Securities and Exchange Commission (``Commission'') the
proposed rule change as described in Items I, II , and III below, which
Items have been prepared by the Exchange. The Exchange filed the
proposed rule change pursuant to Section 19(b)(3)(A) of the Act \3\ and
Rule 19b-4(f)(2) thereunder,\4\ which renders it effective upon filing
with the Commission. The Commission is publishing this notice to
solicit comments on the proposed rule change.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.196-4.
    \3\ 15 U.S.C. 78s(b)(3)(A).
    \4\ 17 CFR 240.19b-4(f)(2).
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange is proposing to implement a fee schedule applicable to
use of the Exchange commencing on the date it begins operating as a
national securities exchange. The Exchange currently intends to
commence operations as a national securities exchange on October 24,
2008.
    The text of the proposed rule change is available at the Exchange's
Web site at http://www.batstrading.com, at the principal office of the
Exchange, and at the Commission's Public Reference Room.

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

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

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

1. Purpose
    The Exchange proposes to implement a fee schedule applicable to use
of the Exchange commencing on the date it begins operating as a
national securities exchange. The Exchange currently intends to
commence operations as a national securities exchange on October 24,
2008. Please find below a description of the fees and rebates that the
Exchange intends to impose under the initial, proposed fee schedule.
    The Exchange does not propose to charge different fees or grant
different rebates depending on the amount of orders submitted to, and/
or trades executed on or through, the Exchange. Accordingly, all fees
and rebates described below are applicable to all Members,\5\
regardless of the overall volume of their trading activities on the
Exchange.
---------------------------------------------------------------------------

    \5\ A Member is any registered broker or dealer that has been
admitted to membership in the Exchange.
---------------------------------------------------------------------------

    (i) Standard Fees for Removing Liquidity.
    The Exchange is proposing to charge $0.0025 per share for
executions that remove liquidity from the Exchange, with the exception
of executions that remove non-displayed liquidity and securities priced
under $1.00 per share, as described below. The charge for removing
liquidity will apply to securities traded on the Exchange pursuant to
unlisted trading privileges that are listed on: (A) The New York Stock
Exchange (``NYSE''); (B) regional exchanges, such as NYSE Arca Equities
(``NYSE Arca'') and NYSE Alternext US (``NYSE Alternext,'' formerly the
American Stock Exchange); and (C) the NASDAQ Stock Market (``NASDAQ'')
(``Tape A Securities'', ``Tape B Securities'' and ``Tape C
Securities'', respectively, and collectively, ``All Tapes'').
    (ii) Standard Rebates for Adding Liquidity.
    With the exception of executions that result from non-displayed
orders and securities priced under $1.00 per share, as described below,
the Exchange is proposing to rebate: (A) $0.0030 per share for
executions that add liquidity to the Exchange in Tape B Securities; and
(B) $0.0024 per share for executions that add liquidity to the Exchange
in Tape A Securities and Tape C Securities.
    (iii) Securities Priced under $1.00 per Share.
    In connection with executions in securities priced under $1.00 per
share, the Exchange does not propose to charge any fee or to provide
any rebates to Members.
    (iv) Routing Charges.
    The Exchange proposes to charge the routing charges described
below. All charges by the Exchange for routing are applicable only in
the event that an order is executed. In other words, there is no charge
for orders that are routed away from the Exchange but are not filled.
In connection with routing of orders away from the Exchange, the
Exchange proposes to charge: (A) $0.0029 per share for Destination
Specific Orders \6\ routed to NASDAQ, the International Securities
Exchange (``ISE''), and the National Securities Exchange (``NSX''); (B)
$0.0028 per share for Destination Specific Orders routed to NYSE Arca;
(C) $0.0009 per share (other than exchange traded funds, or ``ETFs'',
if applicable) \7\ for Destination Specific Orders routed to the NYSE;
(D) $0.0005 per share for Modified Destination Specific Orders \8\
routed to a dark liquidity venue (i.e., an alternative trading system
known as a ``dark pool''); (E) $0.0035 per share for Directed ISO's;
\9\ (F) $0.03 per share for Odd Lot Orders \10\ routed to NYSE Arca in
Tape A Securities and Tape B Securities; (G) 0.004 per share for Odd
Lot Orders routed to NYSE Arca in Tape C Securities; (H) 0.29% of the
total dollar value of the execution of an order for any security (All
Tapes) priced under $1.00 per share that is routed away from the
Exchange; and (I) $0.0029 per share for all other routing options
offered by the Exchange, including routing as part of the Exchange's
default best execution routing strategy (``CYCLE''). The differences
between the fees charged for routing to specific market centers and
routing of specific order types described above are due to different
cost structures at the various market centers to which orders may be
routed and other factors. For instance, lower transaction fees at NYSE
Arca (in round lots) and NYSE allow the Exchange to charge lower
routing fees for Destination Specific Orders routed to such markets
than Destination Specific Orders routed elsewhere (i.e., to

NASDAQ, ISE or NSX) or for odd lots routed to NYSE Arca. Similarly,
lower transaction fees at dark liquidity venues permit the Exchange to
charge lower routing fees for Modified Destination Specific Orders
routed to such venues. Because the Exchange incurs additional costs and
performs additional services in connection with the routing of Directed
ISOs, it charges a higher routing fee for such orders. Finally, because
the Exchange believes that a uniform routing fee for all other orders
routed away from the Exchange (other than those set forth in (A)
through (H) above) provides Members with certainty as to transaction
costs, it proposes to charge a standard routing fee for such orders,
rather than further differentiating routing fees that it charges to
Members.
---------------------------------------------------------------------------

    \6\ As defined in BATS Rule 11.9(c)(10).
    \7\ To the extent any Destination Specific Orders in ETF
products are routed to the NYSE, the charge will be $0.0029 per
share, as set forth in (I) and on the schedule of fees (``all other
routing options offered by the Exchange'').
    \8\ As defined in BATS Rule 11.9(c)(11).
    \9\ As defined in BATS Rule 11.9(d)(2).
    \10\ As defined in BATS Rule 11.9(c)(2).
---------------------------------------------------------------------------

    (v) Fees and Rebates for Non-Displayed Liquidity.
    The Exchange proposes to charge different fees and provide
different rebates for executions involving non-displayed liquidity on
the Exchange's book (this pricing is referred to by the Exchange as
``Dark Match'' pricing on the proposed fee schedule). Because the
Exchange wishes to encourage larger trade sizes to execute against non-
displayed liquidity on the Exchange's book, orders that remove non-
displayed liquidity from the Exchange will be charged fees lower than
the Exchange's standard fees, as set forth on the schedule below.
Conversely, non-displayed orders, including Pegged Orders,\11\ Mid-
Point Peg Orders,\12\ and Non-Displayed Orders,\13\ will receive
rebates lower than the Exchange's standard rebates, as set forth on the
schedule below. Dark Match pricing for rebates does not apply to
Reserve Orders \14\ or Discretionary Orders.\15\
---------------------------------------------------------------------------

    \11\ As defined in BATS Rule 11.9(c)(6).
    \12\ As defined in BATS Rule 11.9(c)(7).
    \13\ As defined in BATS Rule 11.9(c)(9).
    \14\ As defined in BATS Rule 11.9(c)(1).
    \15\ As defined in BATS Rule 11.9(c)(8).
---------------------------------------------------------------------------

    Below is the proposed Dark Match pricing schedule:

------------------------------------------------------------------------
                                                       Rebate/    Fee/
                     Trade size                         share     share
------------------------------------------------------------------------
1-500...............................................   $0.0020   $0.0025
501-5,000...........................................    0.0020    0.0024
5,001-10,000........................................    0.0016    0.0020
10,001-25,000.......................................    0.0010    0.0018
25,001+.............................................    0.0005    0.0015
------------------------------------------------------------------------

2. Statutory Basis
    The Exchange believes that the rule change proposed in this
submission is consistent with the requirements of the Act and the rules
and regulations thereunder that are applicable to a national securities
exchange, and, in particular, with the requirements of Section 6 of the
Act.\16\ Specifically, the proposed rule change is consistent with
Section 6(b)(4) of the Act,\17\ in that it provides for the equitable
allocation of reasonable dues, fees and other charges among members and
other persons using any facility or system which the Exchange operates
or controls. The Exchange notes that it operates in a highly
competitive market in which market participants can readily direct
order flow to competing venues if they deem fee levels at a particular
venue to be excessive. The Exchange believes that its fees and credits
are competitive with those charged by other venues. The Exchange also
believes that the proposed rates further the objectives of Regulation
NMS by promoting competition and granting fair and equal access to all
exchange participants. Finally, the Exchange believes that the proposed
rates are equitable in that they apply uniformly to all Members.
---------------------------------------------------------------------------

    \16\ 15 U.S.C. 78f.
    \17\ 15 U.S.C. 78f(b)(4).
---------------------------------------------------------------------------

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

    The Exchange does not believe that the proposed rule change imposes
any burden on competition.

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

    No written comments were solicited or received.

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

    The foregoing proposed rule change has been designated as a fee
change pursuant to Section 19(b)(3)(A)(ii) of the Act \18\ and Rule
19b-4(f)(2) thereunder,\19\ because it establishes or changes a due,
fee or other charge imposed on members by the Exchange. Accordingly,
the proposal is effective upon filing with the Commission.
---------------------------------------------------------------------------

    \18\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \19\ 17 CFR 240.19b-4(f)(6).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission may summarily abrogate such rule change if it
appears to the Commission that such action is necessary or appropriate
in the public interest, for the protection of investors, or otherwise
in furtherance of the purposes of the Act.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://
www.sec.gov/rules/sro.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File Number SR-BATS-2008-009 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-BATS-2008-009. This file
number should be included on the subject line if e-mail is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/
sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for inspection and
copying in the Commission's Public Reference Room, 100 F Street, NE.,
Washington, DC 20549, on official business days between the hours of 10
a.m. and 3 p.m. Copies of such filing also will be available for
inspection and copying at the principal office of BATS. All comments
received will be posted without change; the Commission does not edit
personal identifying information from submissions. You should submit
only information that you wish to make available publicly. All
submissions should refer to File Number SR-BATS-2008-009 and should be
submitted on or before November 24, 2008.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\20\
---------------------------------------------------------------------------

    \20\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Florence E. Harmon,
Acting Secretary.
 [FR Doc. E8-26110 Filed 10-31-08; 8:45 am]

BILLING CODE 8011-01-P


[Federal Register Volume 76, Number 227 (Friday, November 25, 2011)]
[Rules and Regulations]
[Pages 72617-72619]
[FR Doc No: 2011-30329]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 500, 522, and 556

[Docket No. FDA-2011-N-0003]

Animal Drugs, Feeds, and Related Products; Eprinomectin; N-
Methyl-2-Pyrrolidone

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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

SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect approval of an original new animal drug
application (NADA) filed by Merial Ltd. The NADA provides for the
veterinary prescription use of eprinomectin by

injection for the treatment and control of internal and external
parasites of cattle on pasture with persistent effectiveness. The
current tolerance for the marker residue for total residues of
eprinomectin in edible tissues of cattle is being lowered. The method
of detection for residues of the carcinogenic excipient n-methyl-2-
pyrrolidone (NMP) in edible tissues of cattle is also being codified.

DATES: This rule is effective November 25, 2011. The incorporation by
reference of a certain method listed in this rule is approved by the
Director of the Federal Register as of November 25, 2011.

FOR FURTHER INFORMATION CONTACT: Cindy L. Burnsteel, Center for
Veterinary Medicine (HFV-130), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855,<PHONE_NUMBER>, email:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Merial Ltd., 3239 Satellite Blvd., Bldg.
500, Duluth, GA 30096-4640 filed NADA 141-327 that provides for
veterinary prescription use of LONGRANGE (eprinomectin) Extended-
Release Injectable Parasiticide for the treatment and control of
internal and external parasites of cattle on pasture with persistent
effectiveness. The NADA is approved as of September 26, 2011, and the
regulations are amended in 21 CFR part 522 to reflect the approval.
    As a consequence of the residue depletion characteristics of this
product, the current tolerance for the marker residue for eprinomectin
in the target tissue of cattle is being lowered. Accordingly, the
regulations are amended in 21 CFR part 556. Elsewhere in this issue of
the Federal Register, the approved NADA for an eprinomectin topical
solution used on cattle is being supplemented to provide for this lower
tolerance.
    In addition, FDA has determined that an inactive ingredient in this
product, the excipient n-methyl-2-pyrrolidone (NMP), is a carcinogen.
As required by section 512(d)(1)(I) of the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) (21 U.S.C. 360b(d)(1)(I)), a method of
detection for residues of NMP in edible tissues of cattle is being
codified in 21 CFR part 500, new subpart F, through incorporation by
reference.
    A summary of safety and effectiveness data and information
submitted to support approval of this application may be seen in the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, between 9 a.m. and 4
p.m., Monday through Friday.
    Under section 512(c)(2)(F)(ii) of the FD&C Act, this approval
qualifies for 3 years of marketing exclusivity beginning on the date of
approval.
    The Agency has carefully considered the potential environmental
impact of this action and has concluded that the action will not have a
significant impact on the human environment and that an environmental
impact statement is not required. FDA's finding of no significant
impact and the evidence supporting that finding, contained in an
environmental assessment, may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.
    This rule does not meet the definition of ``rule'' in 5 U.S.C.
804(3)(A) because it is a rule of ``particular applicability.''
Therefore, it is not subject to the congressional review requirements
in 5 U.S.C. 801-808.

List of Subjects

21 CFR Part 500

    Animal drugs, Animal feeds, Cancer, Labeling, Packaging and
containers, Polychlorinated biphenyls (PCBs), Incorporation by
reference.

21 CFR Part 522

    Animal drugs.

21 CFR Part 556

    Animal drugs, Foods.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs and
redelegated to the Center for Veterinary Medicine, 21 CFR parts 500,
522, and 556 are amended as follows:

PART 500--GENERAL

0
1. The authority citation for 21 CFR part 500 continues to read as
follows:

    Authority: 21 U.S.C. 321, 331, 342, 343, 348, 351, 352, 353,
360b, 371.

0
2. Add subpart F, consisting of Sec.  500.1410, to read as follows:

Subpart F--Methods for Detection of Residues of Carcinogenic
Compounds Used in Food-Producing Animals

Sec.  500.1410  N-methyl-2-pyrrolidone.

    (a) Standard for residues. No residues of n-methyl-2-pyrrolidone
may be found in the uncooked edible tissues of cattle as determined by
a method entitled ``Method of Analysis: N-methyl-2-pyrrolidone,''
September 26, 2011, Center for Veterinary Medicine, Food and Drug
Administration, which is incorporated by reference with the approval of
the Director of the Federal Register under 5 U.S.C. 522(a) and 1 CFR
part 51. You may obtain a copy of the method from the Communications
Staff (HFV-12), Center for Veterinary Medicine, Food and Drug
Administration, 7519 Standish Pl., Rockville, MD 20855;<PHONE_NUMBER>;
or go to: http://www.fda.gov/aboutfda/centersoffices/cvm/cvmfoiaelectronicreadingroom/default.htm. You may inspect a copy at the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>,
between 9 a.m. and 4 p.m., Monday through Friday or 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.
    (b) Related conditions of use. See Sec. Sec.  522.814 and 522.955
of this chapter.

PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

0
3. The authority citation for 21 CFR part 522 continues to read as
follows:

    Authority: 21 U.S.C. 360b.

0
4. Add Sec.  522.814 to read as follows:

Sec.  522.814  Eprinomectin.

    (a) Specifications. Each milliliter of solution contains 50
milligrams (mg) eprinomectin.
    (b) Sponsor. See No. 050604 in Sec.  510.600(c) of this chapter.
    (c) Related tolerances. See Sec. Sec.  500.1410 and 556.227 of this
chapter.
    (d) Conditions of use in cattle on pasture--(1) Amount. Administer
1 mg/kilogram of body weight by subcutaneous injection.
    (2) Indications for use. For the treatment and control of the
following internal and external parasites: Gastrointestinal roundworms
(adults and fourth-stage larvae) Cooperia oncophora, C. punctata, C.
surnabada, Trichostrongylus axei, Ostertagia ostertagi (including
inhibited stage); (adults) Haemonchus placei, Oesophagostomum radiatum,
O. lyrata, T. colubriformis; lungworms (adults) Dictyocaulus viviparus;
cattle grubs Hypoderma bovis; mites Sarcoptes scabiei var. bovis.
Prevents reinfection with C. oncophora, C. punctata, and T. axei for
100 days following treatment; H. placei, O. radiatum, O. lyrata, and O.
ostertagi for 120 days following treatment; and D. viviparus for 150
days following treatment.
    (3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian. Animals

intended for human consumption must not be slaughtered within 48 days
of the last treatment. Do not use in female dairy cattle 20 months of
age or older. Use in lactating dairy cows may cause drug residues in
milk. A withdrawal period has not been established for pre-ruminating
calves. Do not use in calves to be processed for veal.

PART 556--TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD

0
5. The authority citation for 21 CFR part 556 continues to read as
follows:

    Authority: 21 U.S.C. 342, 360b, 371.

0
6. In Sec.  556.227, revise paragraph (b) and add paragraph (c) to read
as follows:

Sec.  556.227  Eprinomectin.

* * * * *
    (b) Tolerances. The tolerances for eprinomectin B1a
(marker residue) are:
    (1) Cattle--(i) Liver (target tissue): 1.5 parts per million.
    (ii) Muscle: 100 parts per billion (ppb).
    (iii) Milk: 12 ppb.
    (2) [Reserved]
    (c) Related conditions of use. See Sec. Sec.  522.814 and 524.814
of this chapter.

    Dated: November 17, 2011.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2011-30329 Filed 11-23-11; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 82, Number 147 (Wednesday, August 2, 2017)]
[Notices]
[Pages 35971-35973]
[FR Doc No: 2017-16230]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0689]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; De Novo
Classification Process (Evaluation of Automatic Class III Designation)

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by
September 1, 2017.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX:<PHONE_NUMBER>, or emailed to<EMAIL_ADDRESS>All

comments should be identified with the OMB control number 0910-NEW and
title ``De Novo Classification Process (Evaluation of Automatic Class
III Designation).'' Also include the FDA docket number found in
brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A63, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

De Novo Classification Process (Evaluation of Automatic Class III
Designation)

OMB Control Number 0910--NEW

    The draft guidance entitled ``De Novo Classification Process
(Evaluation of Automatic Class III Designation)'' provides guidance on
the process for the submission and review of a De Novo classification
request (hereafter a ``De Novo request'') under section 513(f)(2) of
the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C.
360c(f)(2)), also known as the De Novo classification process. This
process provides a pathway to class I or class II classification for
medical devices for which general controls or general and special
controls provide a reasonable assurance of safety and effectiveness,
but for which there is no legally marketed predicate device.
    The proposed collection of information is necessary to satisfy the
previously mentioned statutory requirements for implementing this
voluntary submission program.
    In the Federal Register of August 14, 2014 (79 FR 47651), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. Seven organizations commented on the draft
guidance document. None of the comments were related to the information
collection.
    Upon further review of the information collection, it has come to
our attention that the 60-day notice did not include an estimated hour
burden for requests for withdrawal or estimated operating and
maintenance costs for eCopy,\1\ printing, and shipping of De Novo
submissions. To correct this oversight, we have included these
estimates here.
---------------------------------------------------------------------------

    \1\ See the eCopy guidance, ``eCopy Program for Medical Device
Submissions; Guidance for Industry and Food and Drug Administration
Staff,'' at<EMAIL_ADDRESS>---------------------------------------------------------------------------

    FDA estimates the burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Total
                                                             Number of       Number of     Total annual   Average burden                   operating and
                        Activity                            respondents    responses per     responses     per response     Total hours     maintenance
                                                                            respondent                                                         costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                               De Novo request under section 513(f)(2)(i) of the FD&C Act
--------------------------------------------------------------------------------------------------------------------------------------------------------
CDRH....................................................              25               1              25             100           2,500  ..............
CBER....................................................               1               1               1             100             100  ..............
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                               De Novo request under section 513(f)(2)(ii) of the FD&C Act
--------------------------------------------------------------------------------------------------------------------------------------------------------
CDRH....................................................              25               1              25             180           4,500  ..............
CBER....................................................               1               1               1             180             180  ..............
                                                         -----------------------------------------------------------------------------------------------
    Total De Novo requests..............................  ..............  ..............              52  ..............           7,280          $6,308
Request for withdrawal..................................               5               1               5              10              50               5
                                                         -----------------------------------------------------------------------------------------------
        Total...........................................  ..............  ..............  ..............  ..............           7,330           6,313
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs associated with this collection of information.

    FDA estimates from past experience with the De Novo classification
program that the complete process involved with the program under
section 513(f)(2)(i) of the FD&C Act takes approximately 100 hours, and
the complete process under section 513(f)(2)(ii) of the FD&C Act takes
approximately 180 hours. This includes the time for any supplements or
amendments to the original submission. We estimate that requests for
withdrawal take approximately 10 minutes. The average burdens per
response are based upon estimates by FDA administrative and technical
staff who are familiar with the requirements for submission of a De
Novo request (and related materials), have consulted and advised
manufacturers on the submissions, and have reviewed the documentation
submitted.
    Respondents to the information collection are medical device
manufacturers seeking to market medical device products that have been
classified into class III under section 513(f)(2) of the FD&C Act. It
is expected that the number of De Novo requests will reach a steady
rate of approximately 52 submissions per year. We expect that we will
receive approximately five requests for withdrawal per year.
    The operating and maintenance cost for a De Novo submission
includes the cost of printing, shipping, and the eCopy. We estimate the
cost burden for a De Novo submission to be $121.30 ($90 printing + $30
shipping + $1.30 eCopy). The annual cost estimate for De Novo
submissions is $6,308 (rounded) (52 submissions x $121.30). We estimate
the cost for a request for withdrawal to be $1 (rounded) ($0.09
printing 1 page + $0.03 shipping + $1.30 eCopy). The annual cost
estimate for requests for withdrawal is $5.
    The draft guidance also refers to currently approved information
collections found in FDA regulations. The collections of information in
21 CFR part 807, subpart E, are approved under OMB control number 0910-
0120.

    Dated July 27, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-16230 Filed 8-1-17; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 82, Number 238 (Wednesday, December 13, 2017)]
[Notices]
[Pages 58678-58679]
[FR Doc No: 2017-26870]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2014-0387]

Qualification of Drivers; Exemption Applications; Hearing

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

ACTION: Notice of renewal of exemptions; request for comments.

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SUMMARY: FMCSA announces its decision to renew exemptions for five
individuals from the hearing requirement in the Federal Motor Carrier
Safety Regulations (FMCSRs) for interstate commercial motor vehicle
(CMV) drivers. The exemptions enable these hard of hearing and deaf
individuals to continue to operate CMVs in interstate commerce.

DATES: The exemptions were applicable on October 22, 2017. The
exemptions expire on October 22, 2019. Comments must be received on or
before January 12, 2018.

FOR FURTHER INFORMATION CONTACT: Ms. Christine A. Hydock, Chief,
Medical Programs Division,<PHONE_NUMBER>, [email protected], FMCSA,
Department of Transportation, 1200 New Jersey Avenue SE, Room W64-224,
Washington, DC 20590-0001. Office hours are from 8:30 a.m. to 5 p.m.,
e.t., Monday through Friday, except Federal holidays. If you have
questions regarding viewing or submitting material to the docket,
contact Docket Services, telephone<PHONE_NUMBER>.

ADDRESSES: You may submit comments bearing the Federal Docket
Management System (FDMS) Docket No. FMCSA-2014-0387 using any of the
following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the online instructions for submitting
comments.
     Mail: Docket Management Facility; U.S. Department of
Transportation, 1200 New Jersey Avenue SE, West Building Ground Floor,
Room W12-140, Washington, DC 20590-0001.
     Hand Delivery: West Building Ground Floor, Room W12-140,
1200 New Jersey Avenue SE, Washington,

DC, between 9 a.m. and 5 p.m., e.t., Monday through Friday, except
Federal Holidays.
     Fax: 1-202-493-2251.
    Instructions: Each submission must include the Agency name and the
docket number(s) for this notice. Note that all comments received will
be posted without change to http://www.regulations.gov, including any
personal information provided. Please see the Privacy Act heading below
for further information.
    Docket: For access to the docket to read background documents or
comments, go to http://www.regulations.gov at any time or Room W12-140
on the ground level of the West Building, 1200 New Jersey Avenue, SE,
Washington, DC, between 9 a.m. and 5 p.m., e.t., Monday through Friday,
except Federal holidays. The FDMS is available 24 hours each day, 365
days each year. If you want acknowledgment that we received your
comments, please include a self-addressed, stamped envelope or postcard
or print the acknowledgement page that appears after submitting
comments online.
    Privacy Act: In accordance with 5 U.S.C. 553(c), DOT solicits
comments from the public to better inform its rulemaking process. DOT
posts these comments, without edit, including any personal information
the commenter provides, to http://www.regulations.gov, as described in
the system of records notice (DOT/ALL-14 FDMS), which can be reviewed
at http://www.dot.gov/privacy.

I. Background

    Under 49 U.S.C. 31136(e) and 31315, FMCSA may grant an exemption
for five years if it finds ``such exemption would likely achieve a
level of safety that is equivalent to or greater than the level that
would be achieved absent such exemption.'' The statute also allows the
Agency to renew exemptions at the end of the five-year period. FMCSA
grants exemptions from the FMCSRs for a two-year period to align with
the maximum duration of a driver's medical certification.
    The physical qualification standard for drivers regarding hearing
found in 49 CFR 391.41(b)(11) states that a person is physically
qualified to driver a CMV if that person first perceives a forced
whispered voice in the better ear at not less than 5 feet with or
without the use of a hearing aid or, if tested by use of an audiometric
device, does not have an average hearing loss in the better ear greater
than 40 decibels at 500 Hz, 1,000 Hz, and 2,000 Hz with or without a
hearing aid when the audiometric device is calibrated to American
National Standard (formerly ASA Standard) Z24.5--1951.
    49 CFR 391.41(b)(11) was adopted in 1970, with a revision in 1971
to allow drivers to be qualified under this standard while wearing a
hearing aid, 35 FR 6458, 6463 (April 22, 1970) and 36 FR 12857 (July 3,
1971).
    The five individuals listed in this notice have requested renewal
of their exemptions from the hearing standard in 49 CFR 391.41(b)(11),
in accordance with FMCSA procedures. Accordingly, FMCSA has evaluated
these applications for renewal on their merits and decided to extend
each exemption for a renewable two-year period.

II. Request for Comments

    Interested parties or organizations possessing information that
would otherwise show that any, or all, of these drivers are not
currently achieving the statutory level of safety should immediately
notify FMCSA. The Agency will evaluate any adverse evidence submitted
and, if safety is being compromised or if continuation of the exemption
would not be consistent with the goals and objectives of 49 U.S.C.
31136(e) and 31315, FMCSA will take immediate steps to revoke the
exemption of a driver.

III. Basis for Renewing Exemptions

    In accordance with 49 U.S.C. 31136(e) and 31315, each of the five
applicants has satisfied the renewal conditions for obtaining an
exemption from the hearing requirement. The five drivers in this notice
remain in good standing with the Agency. In addition, for Commercial
Driver's License (CDL) holders, the Commercial Driver's License
Information System (CDLIS) and the Motor Carrier Management Information
System (MCMIS) are searched for crash and violation data. For non-CDL
holders, the Agency reviews the driving records from the State Driver's
Licensing Agency (SDLA). These factors provide an adequate basis for
predicting each driver's ability to continue to safely operate a CMV in
interstate commerce. Therefore, FMCSA concludes that extending the
exemption for each of these drivers for a period of two years is likely
to achieve a level of safety equal to that existing without the
exemption.
    As of October 22, 2017, and in accordance with 49 U.S.C. 31136(e)
and 31315, the following five individuals have satisfied the renewal
conditions for obtaining an exemption from the hearing requirement in
the FMCSRs for interstate CMV drivers.

Jon Burley (CO)
Jennifer Campbell (CO)
Richard Carter (MD)
Clint Harmon (IL)
Tami Richardson (NE)

    The drivers were included in docket number FMCSA-2014-0387. Their
exemptions are applicable as of October 22, 2017, and will expire on
October 22, 2019.

IV. Conditions and Requirements

    The exemptions are extended subject to the following conditions:
(1) Each driver must report any crashes or accidents as defined in 49
CFR 390.5; and (2) report all citations and convictions for
disqualifying offenses under 49 CFR part 383 and 49 CFR 391 to FMCSA;
and (3) each driver prohibited from operating a motorcoach or bus with
passengers in interstate commerce. The driver must also have a copy of
the exemption when driving, for presentation to a duly authorized
Federal, State, or local enforcement official. In addition, the
exemption does not exempt the individual from meeting the applicable
CDL testing requirements. Each exemption will be valid for two years
unless rescinded earlier by FMCSA. The exemption will be rescinded if:
(1) The person fails to comply with the terms and conditions of the
exemption; (2) the exemption has resulted in a lower level of safety
than was maintained before it was granted; or (3) continuation of the
exemption would not be consistent with the goals and objectives of 49
U.S.C. 31136(e) and 31315.

V. Preemption

    During the period the exemption is in effect, no State shall
enforce any law or regulation that conflicts with this exemption with
respect to a person operating under the exemption.

VI. Conclusion

    Based upon its evaluation of the five exemption applications, FMCSA
renews the exemptions of the aforementioned drivers from the hearing
requirement in 49 CFR 391.41 (b)(11). In accordance with 49 U.S.C.
31136(e) and 31315, each exemption will be valid for two years unless
revoked earlier by FMCSA.

    Issued on: December 4, 2017.
Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2017-26870 Filed 12-12-17; 8:45 am]
 BILLING CODE 4910-EX-P


[Federal Register Volume 82, Number 66 (Friday, April 7, 2017)]
[Notices]
[Pages 17004-17005]
[FR Doc No: 2017-06932]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #2

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

    Docket Numbers: EC17-100-000.
    Applicants: Invenergy TN LLC.
    Description: Application for Authorization under section 203 of the
Federal Power Act and Request for Waivers and Expedited Action of
Invenergy TN LLC.
    Filed Date: 4/3/17.
    Accession Number: 20170403-5417.
    Comments Due: 5 p.m. ET 4/24/17.

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

    Docket Numbers: ER17-1374-000.
    Applicants: Cube Yadkin Transmission LLC.
    Description: Request for Waiver of the Order No. 1000, Transmission
Planning Requirements of Cube Yadkin Transmission LLC.
    Filed Date: 4/3/17.
    Accession Number: 20170403-5492.
    Comments Due: 5 p.m. ET 4/24/17.

    Docket Numbers: ER17-1375-000.
    Applicants: Wabash Valley Power Association, Inc.
    Description: Sec.  205(d) Rate Filing: Notice of Succession to be
effective 5/1/2017.
    Filed Date: 4/3/17.
    Accession Number: 20170403-5494.
    Comments Due: 5 p.m. ET 4/24/17.

    Docket Numbers: ER17-1376-000.
    Applicants: Midcontinent Independent System Operator, Inc.
    Description: Compliance filing: 2017-04-03_Stored Energy Resource-
Type II Compliance Filing to be effective 9/1/2017.
    Filed Date: 4/3/17.
    Accession Number: 20170403-5496.
    Comments Due: 5 p.m. ET 4/24/17.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or 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: April 3, 2017..
Kimberly D. Bose,
Secretary.
[FR Doc. 2017-06932 Filed 4-6-17; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 87, Number 203 (Friday, October 21, 2022)]
[Rules and Regulations]
[Pages 63940-63943]
[FR Doc No: 2022-22330]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2022-0879; Project Identifier MCAI-2022-00039-T;
Amendment 39-22192; AD 2022-20-08]
RIN 2120-AA64

Airworthiness Directives; Airbus SAS Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: The FAA is adopting a new airworthiness directive (AD) for all
Airbus SAS Model A300 B2K-3C, B2-203, B4-2C, and B4-203 airplanes. This
AD was prompted by reports of cracking of the flight compartment aft
window frame and adjacent fuselage skin. This AD requires require a
one-time check for previously accomplished repairs of the window pane
and adjacent fuselage panel, and applicable corrective actions, as
specified in a European Union Aviation Safety Agency (EASA) AD, which
is incorporated by reference. The FAA is issuing this AD to address the
unsafe condition on these products.

DATES: This AD is effective November 25, 2022.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of November 25,
2022.

ADDRESSES:
    AD Docket: You may examine the AD docket at regulations.gov under
Docket No. FAA-2022-0879; or in person at Docket Operations between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD
docket contains this final rule, the mandatory continuing airworthiness
information (MCAI), any comments received, and other information. The
address for Docket Operations is U.S. Department of Transportation,
Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200
New Jersey Avenue SE, Washington, DC 20590.
    Material Incorporated by Reference:
     For material incorporated by reference (IBR) in this AD,
contact EASA, Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany; telephone
+49 221 8999 000; email [email protected]; website easa.europa.eu. You
may find this IBR material on the EASA website at ad.easa.europa.eu.
     You may view this material at the FAA, Airworthiness
Products Section, Operational Safety Branch, 2200 South 216th St., Des
Moines, WA. For information on the availability of this material at the
FAA, call<PHONE_NUMBER>. It is also available in the AD docket at
regulations.gov under Docket No. FAA-2022-0879. It is also available at
regulations.gov under Docket No. FAA-2022-0879.

FOR FURTHER INFORMATION CONTACT: Dan Rodina, Aerospace Engineer, Large
Aircraft Section, FAA, International Validation Branch, 2200 South
216th St., Des Moines, WA 98198; telephone<PHONE_NUMBER>; email
[email protected].

SUPPLEMENTARY INFORMATION:

Background

    The FAA issued a notice of proposed rulemaking (NPRM) to amend 14
CFR part 39 by adding an AD that would apply to all Airbus SAS Model
A300 B2K-3C, B2-203, B4-2C, and B4-203 airplanes. The NPRM published in
the Federal Register on July 19, 2022 (87 FR 42970). The NPRM was
prompted by EASA AD 2022-0004, dated January 11, 2022 (EASA AD 2022-
0004), issued by EASA, which is the Technical Agent for the Member
States of the European Union. The MCAI terminates the inspections of
the rear lower corner of the flight compartment aft window at fuselage
station (STA) 972/frame (FR) 10, as required by paragraphs (a)(8), (d),
and (e) of FAA AD 2000-10-01, Amendment 39-11725 (65 FR 33441, May 24,
2000), which corresponds to EASA AD 2022-0004.
    In the NPRM, the FAA proposed to require a one-time check for
previously accomplished repairs of the window pane and adjacent
fuselage panel, and applicable corrective actions, as specified in EASA
AD 2022-0004. The FAA is issuing this AD to address the unsafe
condition on these products.
    You may examine the MCAI in the AD docket at regulations.gov under
Docket No. FAA-2022-0879.

Discussion of Final Airworthiness Directive

Comments

    The FAA received a comment from the Air Line Pilots Association
(ALPA), who supported the NPRM without change.

Conclusion

    This product has been approved by the aviation authority of another
country and is approved for operation in the United States. Pursuant to
the FAA's bilateral agreement with this State of Design Authority, it
has notified the FAA of the unsafe condition described in the MCAI
referenced above. The FAA reviewed the relevant data and determined
that air safety requires adopting this AD as proposed. Accordingly, the
FAA is issuing this AD to address the unsafe condition on this product.
Except for minor editorial changes, this AD is adopted as proposed in
the NPRM. None of the changes will increase the economic burden on any
operator.

Related Service Information Under 1 CFR Part 51

    EASA AD 2022-0004 specifies procedures for a one-time check for
previously accomplished repairs of the window pane and adjacent
fuselage panel, and applicable corrective actions. If no repair is
identified, the corrective actions are accomplishing repetitive
ultrasonic inspections of the window frame, and detailed inspections of
the adjacent fuselage panel for cracking, and repair of any cracking.
If any repair is identified, the corrective action is obtaining and
accomplishing further instructions.
    This material is reasonably available because the interested
parties have access to it through their normal course of business or by
the means identified in the ADDRESSES section.

Costs of Compliance

    The FAA estimates that this AD affects 1 airplane of U.S. registry.
The FAA estimates the following costs to comply with this AD:

                                      Estimated Costs for Required Actions
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per       Cost on U.S.
                          Labor cost                              Parts cost        product         operators
----------------------------------------------------------------------------------------------------------------
1 work-hour x $85 per hour = $85.............................              $0              $85              $85
----------------------------------------------------------------------------------------------------------------

    The FAA estimates the following costs to do any necessary on-
condition inspections based on the results of any required actions. The
FAA has no way of determining the number of aircraft that might need
these on-condition inspections:

                 Estimated Costs of On-Condition Actions
------------------------------------------------------------------------
                                                             Cost per
              Labor cost                   Parts cost        product
------------------------------------------------------------------------
3 work-hours x $85 per hour = $255....              $0             $255
------------------------------------------------------------------------

    The FAA has received no definitive data on which to base the cost
estimates for the on-condition repairs or additional instructions
specified in this AD.

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.
    The FAA is 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) Will not affect intrastate aviation in Alaska, and
    (3) 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.

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:

2022-20-08 Airbus SAS: Amendment 39-22192; Docket No. FAA-2022-0879;
Project Identifier MCAI-2022-00039-T.

(a) Effective Date

    This airworthiness directive (AD) is effective November 25,
2022.

(b) Affected ADs

    This AD affects AD 2000-10-01, Amendment 39-11725 (65 FR 33441,
May 24, 2000) (AD 2000-10-01).

(c) Applicability

    This AD applies to all Airbus SAS Model A300 B2K-3C, B2-203, B4-
2C, and B4-203 airplanes, certificated in any category.

(d) Subject

    Air Transport Association (ATA) of America Code 53, Fuselage.

(e) Unsafe Condition

    This AD was prompted by reports of cracking of the flight
compartment aft window frame and adjacent fuselage skin. The FAA is
issuing this AD to address cracking of the wings and fuselage. The
unsafe condition, if not addressed, could result in reduced
structural integrity of the airplane.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Requirements

    Except as specified in paragraph (h) of this AD: Comply with all
required actions and compliance times specified in, and in
accordance with, European Union Aviation Safety Agency (EASA) AD
2022-0004, dated January 11, 2022 (EASA AD 2022-0004).

(h) Exceptions to EASA AD 2022-0004

    (1) Where EASA AD 2022-0004 refers to its effective date, this
AD requires using the effective date of this AD.
    (2) Where paragraph (4) of EASA AD 2022-0004 specifies to
``accomplish those instructions accordingly'' if any crack is
detected, for this AD if any crack is detected, the crack must be
repaired before further flight using a method approved by the
Manager, Large Aircraft Section, International Validation Branch,
FAA; or EASA; or Airbus SAS's EASA Design Organization Approval
(DOA). If approved by the DOA, the approval must include the DOA-
authorized signature.
    (3) Where paragraph (6) of EASA AD 2022-0004 specifies
terminating action, replace the text ``the requirements of paragraph
1.8 of DGAC France AD 1990-222-116(B) R5 are no longer valid,'' with
``the inspections of the rear lower corner of the flight compartment
aft window at fuselage station (STA) 972/frame (FR) 10, as required
by paragraphs (a)(8), (d), and (e) of AD 2000-10-01, are
terminated.''
    (4) The ``Remarks'' section of EASA AD 2022-0004 does not apply
to this AD.

(i) No Reporting Requirement

    Although the service information referenced in EASA AD 2022-0004
specifies to submit certain information to the manufacturer, this AD
does not include that requirement.

(j) Additional AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
Large Aircraft Section, International Validation Branch, FAA, has
the authority to approve AMOCs for this AD, if requested using the
procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19,
send your request to your principal inspector or responsible Flight
Standards Office, as appropriate. If sending information directly to
the Large Aircraft Section, International Validation Branch, send it
to the attention of the person identified in paragraph (k) of this
AD. Information may be emailed to: [email protected].
Before using any approved AMOC, notify your appropriate principal
inspector, or lacking a principal inspector, the manager of the
local flight standards district office/certificate holding district
office.
    (2) Contacting the Manufacturer: For any requirement in this AD
to obtain instructions from a manufacturer, the instructions must be
accomplished using a method approved by the Manager, Large Aircraft
Section, International Validation Branch, FAA; or EASA; or Airbus
SAS's EASA DOA. If approved by the DOA, the approval must include
the DOA-authorized signature.

(k) Additional Information

    For more information about this AD, contact Dan Rodina,
Aerospace Engineer, Large Aircraft Section, FAA, International
Validation Branch, 2200 South 216th St., Des Moines, WA 98198;
telephone<PHONE_NUMBER>; email [email protected].

(l) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference 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 this AD specifies otherwise.
    (i) European Union Aviation Safety Agency (EASA) AD 2022-0004,
dated January 11, 2022.
    (ii) [Reserved].
    (3) For EASA AD 2022-0004, contact EASA, Konrad-Adenauer-Ufer 3,
50668 Cologne, Germany; telephone +49 221 8999 000; email
[email protected]; website easa.europa.eu. You may find this EASA
AD on the EASA website at ad.easa.europa.eu.
    (4) You may view this material at the FAA, Airworthiness
Products Section, Operational Safety Branch, 2200 South 216th St.,
Des Moines, WA. For information on the availability of this material
at the FAA, call<PHONE_NUMBER>.

    (5) You may view this material that is incorporated by reference
at the National Archives and Records Administration (NARA). For
information on the availability of this material at NARA, email
[email protected], or go to: www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued on September 16, 2022.
Christina Underwood,
Acting Director, Compliance & Airworthiness Division, Aircraft
Certification Service.
[FR Doc. 2022-22330 Filed 10-20-22; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 76, Number 187 (Tuesday, September 27, 2011)]
[Notices]
[Page 59682]
[FR Doc No: 2011-24767]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 7518-012]

 Erie Boulevard Hydropower L.P.; Notice of Dispute Resolution
Panel Meeting and Technical Conference

    On September 16, 2011, Commission staff, in response to the filing
of notice of study dispute by the New York State Department of
Environmental Conservation (NYSDEC) on August 29, 2011, convened a
single three-person Dispute Resolution Panel (Panel) pursuant to 18 CFR
5.14(d).
    The Panel will hold a technical conference at the time and place
noted below. The session will address study disputes regarding six
separate studies that focus on aquatic resource related issues. The
disputes primarily address the Commission's determination on data
collection and study methodologies being required for assessing project
related effects on aquatic resources. The focus of the technical
session is for the disputing agency, applicant, and Commission to
provide the Panel with additional information necessary to evaluate the
disputed studies. All local, state, and federal agencies, Indian
tribes, and other interested parties are invited to attend the meeting
as observers. The Panel may also request information or clarification
on written submissions as necessary to understand the matters in
dispute. The Panel will limit all input that it receives to the
specific studies or information in dispute and will focus on the
applicability of such studies or information to the study criteria
stipulated in 18 CFR 5.9(b). If the number of participants wishing to
speak creates time constraints, the Panel may, at their discretion,
limit the speaking time for each participant.
    If you have any questions, please contact Ryan Hansen at (202) 502-
8074.

Technical Conference

    Date: Wednesday, October 5, 2011.
    Time: 8:30 a.m.-5 p.m. (EDT).
    Place: Doubletree Hotel Syracuse, 6301 State Route 298, East
Syracuse, New York 13057.
    Phone:<PHONE_NUMBER>.

    Dated: September 20, 2011.
Kimberly D. Bose,
Secretary.
[FR Doc. 2011-24767 Filed 9-26-11; 8:45 am]
BILLING CODE 6717-01-P


                                  Appendix B
                             Consultation Results
                                   Exhibit 1

                             Consultation Results
     No changes in burden estimates based on November 2018 consultations.


[Federal Register: June 9, 2008 (Volume 73, Number 111)]
[Proposed Rules]
[Page 32520]
[DOCID:fr09jn08-20]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

49 CFR Parts 383, 384, and 385

[Docket No. FMCSA-2007-27659]
RIN 2126-AB02

Commercial Driver's License Testing and Commercial Learner's
Permit Standards; Extension of Comment Period

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

ACTION: Proposed rule; extension of comment period.

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SUMMARY: In response to several requests, the Federal Motor Carrier
Safety Administration (FMCSA) extends until July 9, 2008, the comment
period for the notice of proposed rulemaking (NPRM) that was published
on April 9, 2008.

DATES: Please submit comments regarding the NPRM to the docket by July
9, 2008.

ADDRESSES: Comments must be identified by Docket ID Number FMCSA-2007-
27659, and submitted by one of the following methods:
     Electronically: Through the Federal Docket Management
System (FDMS), at http://www.regulations.gov; and follow the
instructions for submitting comments.
     Mail/Courier: U.S. Department of Transportation, Docket
Management Facility, West Building Ground Floor, Room W12-140, 1200 New
Jersey Ave, SE., Washington, DC 20590, between 9 a.m. and 5 p.m., e.t.,
Monday through Friday, except Federal holidays.
     Fax:<PHONE_NUMBER>.
     Docket: For access to the docket to read comments received
and background material, go to the Federal Docket Management System
(FDMS) at http://www.regulations.gov, and search for docket ID Number
FMCSA-2007-27659. Comments may also be inspected at the U.S. Department
of Transportation, Docket Management Facility, West Building Ground
Floor, Room W12-140, 1200 New Jersey Ave, SE., Washington, DC 20590,
between 9 a.m. and 5 p.m., e.t., Monday through Friday, except Federal
holidays.
     Privacy Act: Regardless of the method used for submitting
comments, all comments or material will be posted without change to the
FDMS, including personal information. Anyone can search the electronic
form of all of our dockets in FDMS by the name of the individual
submitting the document (or signing the comment, if submitted on behalf
of an association, business, labor union, etc.). You may review DOT's
complete Privacy Act Statement published in the Federal Register on
April 11, 2000 (65 FR 19476) or you may visit http://
DocketsInfo.dot.gov.

FOR FURTHER INFORMATION CONTACT: Mr. Robert Redmond, Office of Safety
Programs, Commercial Driver's License Division, telephone (202) 366-
5014 or e-mail<EMAIL_ADDRESS>Office hours are from 8 a.m. to
4:30 p.m.

SUPPLEMENTARY INFORMATION: On April 9, 2008 (73 FR 19282), FMCSA
published a notice of proposed rulemaking (NPRM) in the Federal
Register concerning proposed requirements related to commercial
driver's license testing and commercial learner's permit standards. We
provided the public with a 60-day comment period that expires on June
9, 2008. Several commenters have submitted requests for an extension of
30 days beyond June 9, which are in the docket. Accordingly, FMCSA
extends the comment period for an additional 30 days, which now expires
on July 9, 2008.

    Issued on: June 4, 2008.
John H. Hill,
Administrator.
[FR Doc. E8-12876 Filed 6-6-08; 8:45 am]

BILLING CODE 4910-EX-P


[Federal Register Volume 83, Number 170 (Friday, August 31, 2018)]
[Rules and Regulations]
[Page 44479]
[FR Doc No: 2018-18930]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2018-0840]

Drawbridge Operation Regulation; New Jersey Intracoastal Waterway
(NJICW), Atlantic City, NJ

AGENCY: Coast Guard, DHS.

ACTION: Notice of deviation from drawbridge regulation.

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SUMMARY: The Coast Guard has issued a temporary deviation from the
operating schedule that governs the US40-322 (Albany Avenue) Bridge
across the New Jersey Intracoastal Waterway (NJICW) (Inside Thorofare),
mile 70.0, at Atlantic City, NJ. The deviation is necessary to
accommodate the free movement of pedestrians and vehicles during the
3rd Annual Iron Man. This deviation allows the bridge to remain in the
closed-to-navigation position.

DATES: The deviation is effective from 6 a.m. to 4 p.m. on September
23, 2018.

ADDRESSES: The docket for this deviation [USCG-2018-0840], is available
at http://www.regulations.gov. Type the docket number in the ``SEARCH''
box and click ``SEARCH''. Click on Open Docket Folder on the line
associated with this deviation.

FOR FURTHER INFORMATION CONTACT: If you have questions on this
temporary deviation, call or email Mr. Martin Bridges, Bridge
Administration Branch Fifth District, Coast Guard, telephone 757-398-
6422, email [email protected].

SUPPLEMENTARY INFORMATION: The event director, DelMoSports, LLC, with
approval from the New Jersey Department of Transportation, who owns and
operates the US40-322 (Albany Avenue) Bridge across the NJICW (Inside
Thorofare), mile 70.0, at Atlantic City, NJ, has requested a temporary
deviation from the current operating regulations. This temporary
deviation is necessary to accommodate the free movement of pedestrians
and vehicles during the 3rd Annual Iron Man. The bridge is a double
bascule bridge and has a vertical clearance in the closed position of
10 feet above mean high water.
    The current operating schedule is set out in 33 CFR 117.733(f).
Under this temporary deviation, the bridge will be maintained in the
closed-to-navigation position from 6 a.m. to 4 p.m. on September 23,
2018. The NJICW (Inside Thorofare) is used by recreational vessels. The
Coast Guard has carefully coordinated the restrictions with waterway
users in publishing this temporary deviation.
    Vessels able to pass through the bridge in the closed position may
do so at anytime. The bridge will be able to open for emergencies and
there is no immediate alternate route for vessels unable to pass
through the bridge in the closed position. The Coast Guard will also
inform the users of the waterway through our Local and Broadcast Notice
to Mariners of the change in operating schedule for the bridge so that
vessels can arrange their transits to minimize any impacts caused by
the temporary deviation.
    In accordance with 33 CFR 117.35(e), the drawbridge must return to
its regular operating schedule immediately at the end of the effective
period of this temporary deviation. This deviation from the operating
regulations is authorized under 33 CFR 117.35.

    Dated: August 27, 2018.
Hal R. Pitts,
Bridge Program Manager, Fifth Coast Guard District.
[FR Doc. 2018-18930 Filed 8-30-18; 8:45 am]
 BILLING CODE 9110-04-P