[Federal Register Volume 81, Number 60 (Tuesday, March 29, 2016)]
[Rules and Regulations]
[Pages 17386-17387]
[FR Doc No: 2016-07011]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2016-0230]

Drawbridge Operation Regulation; Lake Washington Ship Canal,
Seattle, WA

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 University Bridge, mile 4.3, and
the Montlake Bridge, mile 5.2, both crossing Lake Washington Ship Canal
at Seattle, WA. The deviation is necessary to accommodate the ``Beat
the Bridge'' foot race event. This deviation allows the bridges to
remain in the closed-to-navigation position to allow for the safe
movement of event participants.

DATES: This deviation is effective from 8 a.m. to 9:30 a.m. on May 15,
2016.

ADDRESSES: The docket for this deviation, [USCG-2016-0230] 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. Steven Fischer, Bridge
Administrator, Thirteenth Coast Guard District; telephone<PHONE_NUMBER>,
email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The Seattle Department of Transportation
requested a temporary deviation from the operating schedule for the
University Bridge, mile 4.3, and the Montlake Bridge, mile 5.2, both
crossing Lake Washington Ship Canal at Seattle, WA, to facilitate safe
passage of participants in the ``Beat the Bridge'' foot race. The
University Bridge provides a vertical clearance of 30 feet in the
closed-to-navigation position. The Montlake Bridge provides 30 feet of
vertical clearance in the closed-to-navigation position throughout the
navigation channel, and 46 feet of vertical clearance in the closed-to-
navigation position throughout the center 60 feet of the bridge.
Vertical clearances are referenced to the Mean Water Level of Lake
Washington. The normal operating schedule for both the University
Bridge and Montlake Bridge is in 33 CFR 117.1051. During this deviation
period, the University Bridge, mile 4.3, need not open to marine
vessels from 8 a.m. to 9:30 a.m. on May 15, 2016. The Montlake Bridge,
mile 5.2, need not open to marine vessels from 8:15 a.m. to 8:45 a.m.
on May 15, 2016. Waterway usage on Lake Washington Ship Canal ranges
from commercial tug and barge to small pleasure craft.
    Vessels able to pass through the bridges in the closed positions
may do so at any time. Both bridges will be able to open for
emergencies, and there is no immediate alternate route for vessels to
pass. The Coast Guard will also inform the users of the waterways
through our Local and Broadcast Notices to Mariners of the change in
operating schedule for the bridge so that vessel operators can arrange
their transits to minimize any impact 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: March 23, 2016.
Steven M. Fischer,
Bridge Administrator, Thirteenth Coast Guard District.
[FR Doc. 2016-07011 Filed 3-28-16; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register: May 12, 2010 (Volume 75, Number 91)]
[Rules and Regulations]
[Page 26673-26678]
[DOCID:fr12my10-11]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2009-0307; FRL-8822-7]

Clethodim; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of
clethodim in or on the raw agricultural commodity artichoke, globe;
bushberry subgroup 13-07B; caneberry subgroup 13-07A; and peach. This
regulation additionally removes the existing tolerances on lettuce leaf
and spinach, as they are covered by the leafy greens subgroup 4A and
removes the tolerance for flax seed at 0.50 ppm because there is one
for flax seed at 0.6 ppm. The Interregional Research Project Number 4
(IR-4) requested these tolerances under the Federal Food, Drug, and
Cosmetic Act (FFDCA).

DATES: This regulation is effective May 12, 2010. Objections and
requests for hearings must be received on or before July 12, 2010, and
must be filed in accordance with the instructions provided in 40 CFR
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2009-0307. All documents in the
docket are listed in the docket index available at http://
www.regulations.gov. Although listed in the index, some information is
not publicly available, e.g., Confidential Business Information (CBI)
or other information whose disclosure is restricted by statute. Certain
other material, such as copyrighted material, is not placed on the
Internet and will be publicly available only in hard copy form.
Publicly available docket materials are available in the electronic
docket at http://www.regulations.gov, or, if only available in hard
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket Facility telephone number is (703)
305-5805.

FOR FURTHER INFORMATION CONTACT: Andrew Ertman, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to those
engaged in the following activities:

     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather to
provide a guide for readers regarding entities likely to be affected by
this action. Other types of entities not listed in this unit could also
be affected. The North American Industrial Classification System
(NAICS) codes have been provided to assist you and others in
determining whether this action might apply to certain entities. If you
have any questions regarding the applicability of this action to a
particular entity, consult the person listed under FOR FURTHER
INFORMATION CONTACT.

B. How Can I Get Electronic Access to Other Related Information?

    You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Government
Printing Office's e-CFR cite at http://www.gpoaccess.gov/ecfr.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, 21 U.S.C. 346a, any person may file
an objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2009-0307 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing, and must be received by the Hearing Clerk on or before
July 12, 2010. Addresses for mail and hand delivery of objections and
hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit this copy, identified by docket ID number
EPA-HQ-OPP-2009-0307, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket Facility's normal hours of operation (8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays).
Special arrangements should be made for deliveries of boxed
information. The Docket Facility telephone number is<PHONE_NUMBER>.

II. Petition for Tolerance

    In the Federal Register of June 10, 2009 (74 FR 27538) (FRL-8417-
7), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
8E7505) by IR-4 Project Headquarters, Rutgers, The State University of
New Jersey, 500 College Road East, Suite 201 W, Princeton, NJ 08540.
The petition requested that 40 CFR 180.458 be amended by establishing
tolerances for combined residues of the herbicide clethodim, ((E)-()-2-
[1-[[(3-chloro-2-propenyl)oxy]imino]propyl]-5-[2-(ethylthio)propyl]-3-
hydroxy-2-cyclohexen-1-one) and its metabolites containing the 5-(2-
(ethylthio)propyl]cyclohexen-3-one and the 5-[2-(ethylthio)propyl]-5-
hydroxycyclohexen-3-one moieties and their sulfoxides and sulfones,
expressed as clethodim, in or on the raw agricultural commodity
artichoke, globe at 1.3 parts per million (ppm), bushberry subgroup 13-
07B at 3.0 ppm, caneberry subgroup 13-07A at 0.30 ppm and peach at 0.20
ppm. That notice referenced a summary of the petition prepared by
Valent U.S.A. Corporation, the registrant, which is available in the
docket, http://www.regulations.gov. There were no comments received in
response to the notice of filing.
    Based upon review of the data supporting the petition, EPA has
modified the bushberry subgroup 13-07B tolerance from 3.0 ppm to 0.20
ppm and the globe artichoke tolerance from 1.3 ppm to 1.2 ppm. The
reason for these changes is explained in Unit IV.C.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. . .
.''
    Consistent with section 408(b)(2)(D) of FFDCA, and the factors
specified in section 408(b)(2)(D) of FFDCA, EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has sufficient data to assess the hazards of and to
make a determination on aggregate exposure for clethodim including
exposure resulting from the tolerances established by this action.
EPA's assessment of exposures and risks associated with clethodim
follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. Clethodim has a low order of acute toxicity via oral, dermal
and inhalation routes of exposure. Clethodim produces mild ocular
irritation and moderate skin irritation. It is not a dermal sensitizer.
The subchronic and chronic toxicity data show that clethodim produces
consistent effects in the liver characterized by increased liver
weights and centrilobular hepatic hypertrophy in rats, mice, and dogs.
Decreased body weight is also a consistent finding. Treatment related
increase in tumor incidence is not observed in rat and mouse
carcinogenicity studies. Clethodim is not genotoxic. The data
demonstrate no reproductive effect in rats and no developmental effects
in rabbits. No effects were seen in offspring of the 2-generation
study. In the rat developmental toxicity study, reduced fetal weights
and increased incidence of reduced ossification were seen in the
fetuses at the maternal toxic dose level.

The data show no increase in susceptibility in the young.
    Specific information on the studies received and the nature of the
adverse effects caused by clethodim as well as the no-observed-adverse-
effect-level (NOAEL) and the lowest-observed-adverse-effect-level
(LOAEL) from the toxicity studies can be found at http://
www.regulations.gov on pages 45-50 of the document titled ``Clethodim
Human Health Risk Assessment for Proposed Uses on Caneberry Subgroup
13-07A, Bushberry Subgroup 13-07B, Peach, and Globe Artichoke'' in
docket ID number EPA-HQ-OPP-2009-0307.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors are used in conjunction with
the POD to calculate a safe exposure level - generally referred to as a
population-adjusted dose (PAD) or a reference dose (RfD) - and a safe
margin of exposure (MOE). For non-threshold risks, the Agency assumes
that any amount of exposure will lead to some degree of risk. Thus, the
Agency estimates risk in terms of the probability of an occurrence of
the adverse effect expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see http://www.epa.gov/
pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for clethodim used for
human risk assessment is shown in the Table of this unit.

    Table--Summary of Toxicological Doses and Endpoints for Clethodim for Use in Human Health Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                       Point of Departure and
          Exposure/Scenario              Uncertainty/Safety     RfD, PAD, LOC for Risk   Study and Toxicological
                                              Factors                 Assessment                 Effects
----------------------------------------------------------------------------------------------------------------
Acute dietary                         N/A                      N/A                      None Selected.
 (All Populations)..................                                                    There were no effects
                                                                                observed in oral
                                                                                toxicity studies
                                                                                including developmental
                                                                                toxicity studies in
                                                                                rats and rabbits that
                                                                                could be attributable
                                                                                to a single dose
                                                                                (exposure). Therefore,
                                                                                a dose and endpoint
                                                                                were not selected for
                                                                                this exposure scenario.
----------------------------------------------------------------------------------------------------------------
Chronic dietary                       NOAEL= 1.0 mg/kg/day     Chronic RfD = 0.01 mg/   Chronic Toxicity-Dog (1-
(All populations)...................  UFA = 10x..............   kg/day                   year).
                                      UFH = 10x..............  cPAD = 0.01 mg/kg/day..  Alterations in
                                      FQPA SF = 1x...........                            hematology and clinical
                                                                                chemistry parameters
                                                                                and increased absolute
                                                                                and relative liver
                                                                                weights observed at the
                                                                                LOAEL of 75 mg/kg/day.
----------------------------------------------------------------------------------------------------------------
Cancer                                   Classification: ``Not likely to be Carcinogenic to Humans'' based on
(Oral, dermal, inhalation)..........                       feeding studies in rats and mice.
----------------------------------------------------------------------------------------------------------------
UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members
  of the human population (intraspecies). FQPA SF = Food Quality Protection Act Safety Factor. PAD = population
  adjusted dose (a = acute, c = chronic). RfD = reference dose. LOC = level of concern.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to clethodim, EPA considered exposure under the petitioned-for
tolerances as well as all existing clethodim tolerances in 40 CFR
180.458. EPA assessed dietary exposures from clethodim in food as
follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure.
    No such effects were identified in the toxicological studies for
clethodim; therefore, a quantitative acute dietary exposure assessment
is unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA 1994-1996
and 1998 CSFII. The chronic dietary (food and drinking water) exposure
assessment is partially refined, i.e., based on the assumption of
tolerance-level residues for most commodities and average percent crop
treated information for some crops. An anticipated residue (AR) value
was used for succulent snap bean.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that clethodim is classified as ``Not Likely to be
Carcinogenic to Humans.'' Therefore, a dietary exposure assessment for
the purpose of assessing cancer risk is unnecessary.
    iv. Anticipated residue and percent crop treated (PCT) information.
Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data and
information on the anticipated residue levels of pesticide residues in
food and the actual levels of pesticide residues that have been
measured in food. If EPA relies on such information, EPA must require
pursuant to section 408(f)(1) of FFDCA that data be provided 5 years
after the tolerance is established, modified, or left in effect,
demonstrating that the levels in food are not above the levels
anticipated. For the present action, EPA will issue such data call-ins
as are required by section 408(b)(2)(E) of FFDCA and authorized under
section 408(f)(1) of FFDCA. Data will be required to be submitted no
later than 5 years from the date of issuance of these tolerances.
    Section 408(b)(2)(F) of FFDCA states that the Agency may use data
on the actual percent of food treated for assessing chronic dietary
risk only if:
     Condition a: The data used are reliable and provide a
valid basis to show what percentage of the food

derived from such crop is likely to contain the pesticide residue.
     Condition b: The exposure estimate does not underestimate
exposure for any significant subpopulation group.
     Condition c: Data are available on pesticide use and food
consumption in a particular area, the exposure estimate does not
understate exposure for the population in such area.
In addition, the Agency must provide for periodic evaluation of any
estimates used. To provide for the periodic evaluation of the estimate
of PCT as required by section 408(b)(2)(F) of FFDCA, EPA may require
registrants to submit data on PCT.
    The Agency estimated the percent crop treated for existing uses as
follows:
    Beets 1%, Broccoli 10%, Cabbage 1%, Cantaloupes 1%, Carrots 10%,
Celery 5%, Cotton 1%, Cucumbers 1%, Dry beans 5%, Lettuce 1%, Onions
10%, Peanuts 5%, Potatoes 5%, Pumpkins 5%, Soybeans 5%, Squash 5%,
Strawberries 1%, Sugar beets 45%, Sunflowers 20%, Sweet potatoes 1%,
Tomatoes 1%, Watermelons 5%.
    In most cases, EPA uses available data from United States
Department of Agriculture/National Agricultural Statistics Service
(USDA/NASS), proprietary market surveys, and the National Pesticide Use
Database for the chemical/crop combination for the most recent 6-7
years. EPA uses an average PCT for chronic dietary risk analysis. The
average PCT figure for each existing use is derived by combining
available public and private market survey data for that use, averaging
across all observations, and rounding to the nearest 5%, except for
those situations in which the average PCT is less than one. In those
cases, 1% is used as the average PCT and 2.5% is used as the maximum
PCT. EPA uses a maximum PCT for acute dietary risk analysis. The
maximum PCT figure is the highest observed maximum value reported
within the recent 6 years of available public and private market survey
data for the existing use and rounded up to the nearest multiple of 5%.
    The Agency believes that the three conditions discussed in Unit
III.C.1.iv. have been met. With respect to Condition a, PCT estimates
are derived from Federal and private market survey data, which are
reliable and have a valid basis. The Agency is reasonably certain that
the percentage of the food treated is not likely to be an
underestimation. As to Conditions b and c, regional consumption
information and consumption information for significant subpopulations
is taken into account through EPA's computer-based model for evaluating
the exposure of significant subpopulations including several regional
groups. Use of this consumption information in EPA's risk assessment
process ensures that EPA's exposure estimate does not understate
exposure for any significant subpopulation group and allows the Agency
to be reasonably certain that no regional population is exposed to
residue levels higher than those estimated by the Agency. Other than
the data available through national food consumption surveys, EPA does
not have available reliable information on the regional consumption of
food to which clethodim may be applied in a particular area.
    2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for clethodim in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of clethodim. Further information regarding EPA
drinking water models used in pesticide exposure assessment can be
found at http://www.epa.gov/oppefed1/models/water/index.htm.
    Based on the First Index Reservoir Screening Tool (FIRST) and
Screening Concentration in Ground Water (SCI-GROW) models, the
estimated drinking water concentrations (EDWCs) of clethodim for
chronic exposures for non-cancer assessments are 13.0 ppb for surface
water and 9.8 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For chronic dietary risk
assessment, the water concentration value of 13.0 ppb was used to
assess the contribution to drinking water.
    3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets).
    Clethodim is not registered for any specific use patterns that
would result in residential exposure.
    4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
    EPA has not found clethodim to share a common mechanism of toxicity
with any other substances, and clethodim does not appear to produce a
toxic metabolite produced by other substances. For the purposes of this
tolerance action, therefore, EPA has assumed that clethodim does not
have a common mechanism of toxicity with other substances. For
information regarding EPA's efforts to determine which chemicals have a
common mechanism of toxicity and to evaluate the cumulative effects of
such chemicals, see EPA's website at http://www.epa.gov/pesticides/
cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the Food Quality
Protection Act (FQPA) Safety Factor (SF). In applying this provision,
EPA either retains the default value of 10X, or uses a different
additional safety factor when reliable data available to EPA support
the choice of a different factor.
    2. Prenatal and postnatal sensitivity. There is no evidence of
increased susceptibility of fetuses as compared to maternal animals
following in utero and/or postnatal exposure to clethodim in the
developmental toxicity studies in rats or rabbits, and no increased
sensitivity in pups as compared to adults in the 2-generation rat
reproduction toxicity study. There are no residual uncertainties
concerning prenatal and postnatal toxicity and no neurotoxicity
concerns.
    3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1X. That decision is based on the following
findings:
    i. Except for the new requirements of an immunotoxicity study and
an acute and subchronic neurotoxicity battery, the available toxicity
database for clethodim is sufficient and the exposure data are complete
or are estimated based on data that reasonably account for potential
exposures. In the absence of the immunotoxicity and acute and
subchronic neurotoxicity studies, the available toxicity data for
clethodim have been thoroughly examined for any information which
suggests a potential for neurotoxicity or immunotoxicity.

The analysis did not reveal such information and the Agency does not
believe that conducting these studies will result in a NOAEL less than
the currently selected NOAELs for risk assessment. Therefore, a
database uncertainty factor (UFdb) is not needed to account
for the lack of these studies.
    ii. There is no evidence of susceptibility following in utero and/
or postnatal exposure in the developmental toxicity studies in rats or
rabbits, and in the 2-generation rat reproduction study. There are no
residual uncertainties concerning prenatal and postnatal toxicity.
    iii. There is no evidence that clethodim is a neurotoxic chemical
and there is no need for a developmental neurotoxicity study or
additional UFs to account for neurotoxicity.
    iv. There are no residual uncertainties identified in the exposure
data base. The chronic dietary food exposure assessment utilized
tolerance level residues for most commodities and incorporated average
PCT data for some commodities. There is no potential for residential
exposure. The dietary (food and drinking water) exposure assessment
will not underestimate the potential exposure for infants, children,
and/or women of childbearing age.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the appropriate PODs to ensure that an
adequate MOE exists.
    1. Acute risk. An acute aggregate risk assessment takes into
account acute exposure estimates from dietary consumption of food and
drinking water. No adverse effect resulting from a single oral exposure
was identified and no acute dietary endpoint was selected. Therefore,
clethodim is not expected to pose an acute risk.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
clethodim from food and drinking water will utilize 79% of the cPAD for
all infants <1 year old, the population group receiving the greatest
exposure. There are no residential uses for clethodim.
    3. Short-term risk. Short-term aggregate exposure takes into
account short-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level).
    A short-term adverse effect was identified; however, clethodim is
not registered for any use patterns that would result in short-term
residential exposure. Short-term risk is assessed based on short-term
residential exposure plus chronic dietary exposure. Because there is no
short-term residential exposure and chronic dietary exposure has
already been assessed under the appropriately protective cPAD (which is
at least as protective as the POD used to assess short-term risk), no
further assessment of short-term risk is necessary, and EPA relies on
the chronic dietary risk assessment for evaluating short-term risk for
clethodim.
    4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term residential exposure plus chronic
exposure to food and drinking water (considered to be a background
exposure level).
    An intermediate-term adverse effect was identified; however,
clethodim is not registered for any use patterns that would result in
intermediate-term residential exposure. Intermediate-term risk is
assessed based on intermediate-term residential exposure plus chronic
dietary exposure. Because there is no intermediate-term residential
exposure and chronic dietary exposure has already been assessed under
the appropriately protective cPAD (which is at least as protective as
the POD used to assess intermediate-term risk), no further assessment
of intermediate-term risk is necessary, and EPA relies on the chronic
dietary risk assessment for evaluating intermediate-term risk for
clethodim.
    5. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, clethodim is not expected to pose a cancer risk to humans.
    6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population or to infants and children from aggregate
exposure to clethodim residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate plant analytical methods are available for tolerance
enforcement. Method RM-26B-2 (a gas chromatography method with flame
photometric detection in the sulfur mode (GC/FPD-S) and the
confirmatory method RM-26D-2 (a high performance liquid chromatography
method with ultraviolet detection (HPLC/UV) have been forwarded to FDA
as enforcement methods for publication in the Pesticides Analytical
Manual, Volume II (PAM II). Method RM-26B-2 has undergone a successful
validation in an EPA laboratory. Method RM-26B-2 and Method RM-26B-3 (a
modification of Method RM-26B-2) determine the combined residues of
clethodim and its metabolites containing the 2-cyclohexen-1-one moiety
determined as the dimethyl esters of clethodim sulfoxide and 5-OH
clethodim sulfone (DME and DME-OH, respectively) and reported as
clethodim equivalents.
    A modification of Method RM-26B-3 (GC/FPD-S) was used for
quantitation of clethodim residues in/on blueberry, caneberry, peach
and globe artichoke samples from the submitted field trials. The method
is adequate for data collection based on validation data.
    The method may be requested from: Chief, Analytical Chemistry
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD
20755-5350; telephone number:<PHONE_NUMBER>; e-mail address:
<EMAIL_ADDRESS>
B. International Residue Limits

    There are no Codex, Canadian, or Mexican maximum residue limits
(MRLs)/tolerances established at this time for residues of clethodim in
or on the commodities receiving tolerances in this document. However,
Agriculture and Agri-Food Canada (AAFC) and IR-4 developed residue
field trial data for blueberry jointly and submitted these data to the
Pest Management Regulatory Agency (PMRA) and EPA. Both PMRA and EPA
will be establishing MRLs for bushberry subgroup 13-07B at the same
level.

C. Revisions to Petitioned-For Tolerances

    The globe artichoke tolerance is a reduction from the proposed 1.3
ppm to 1.2 ppm based on the tolerance spreadsheet summary of clethodim
field trial data under the Guidance for Setting Pesticide Tolerances
Based on Field Trial Data SOP.
    The recommended bushberry subgroup 13-07B tolerance is a reduction
from the proposed 3.0 ppm to 0.20 ppm. The 0.20 ppm recommended
tolerance is based on the lowest level of method validation and
excludes the lowbush blueberry data since the lowbush blueberry data
were obtained by over-the-top foliar spray instead of

according to the proposed use of spray directed at the base of the
plants and only one study was submitted on low-growing berries.
    The paragraph and table in (a)(2) is being removed because the
tolerances in this section have expired.
    The tolerances for lettuce leaf and spinach are being removed in
paragraph (a)(3) as they are covered by the leafy greens subgroup 4A.
    The tolerance for flax seed at 0.50 ppm is being removed in
paragraph (a)(3) because there is one for flax seed at 0.6 ppm.

V. Conclusion

    Therefore, tolerances are established for residues of clethodim,
including its metabolites and degradates, in or on the raw agricultural
commodities artichoke, globe at 1.2 ppm, bushberry subgroup 13-07B at
0.20 ppm, caneberry subgroup 13-07A at 0.30 ppm and peach at 0.20 ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under section 408(d) of
FFDCA in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). Because this final rule has been
exempted from review under Executive Order 12866, this final rule is
not subject to Executive Order 13211, entitled Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
Protection of Children from Environmental Health Risks and Safety Risks
(62 FR 19885, April 23, 1997). This final rule does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any
special considerations under Executive Order 12898, entitled Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under section 408(d) of FFDCA, such as the tolerance in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.
    This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled Federalism (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (65 FR
67249, November 9, 2000) do not apply to this final rule. In addition,
this final rule does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (Public Law 104-4).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272
note).

VII. Congressional Review Act

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

List of Subjects in 40 CFR Part 180

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

    Dated: May 4, 2010.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

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

PART 180--[AMENDED]

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

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

0
2. Section 180.458 is amended as follows:
0
i. Remove paragraph (a)(2);
0
ii. Redesignate paragraph (a)(3) as (a)(2);
0
iii. Alphabetically add the commodities to newly designated paragraph
(a)(2);
0
iv. Redesignate paragraph (a)(4) as (a)(3);
0
v. Remove the existing tolerances on lettuce leaf, and spinach in newly
designated paragraph (a)(2);
0
vi. Remove the tolerance for flax seed at 0.50 ppm in newly designated
paragraph (a)(2).
    The amendments read as follows:

Sec.  180.458  Clethodim; tolerances for residues.

    (a) General. * * *
    (2) Tolerances are established for the combined residues of the
herbicide clethodim [(E)-()-2-[1-[[(3-chloro-2-
propenyl)oxy]imino]propyl]-5-[2-(ethylthio)propyl]-3-hydroxy-2-
cyclohexen-1-one] and its metabolites containing the 5-(2-
ethylthiopropyl)cyclohexen-3-one and 5-(2-ethylthiopropyl)-5-
hydroxycyclohexen-3-one moieties and their sulphoxides and sulphones,
expressed as clethodim tolerance residues for the following
commodities:

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
                                * * * * *
Artichoke, globe.....................................                1.2
                                * * * * *
Bushberry subgroup 13-07B............................               0.20
Caneberry subgroup 13-07A............................               0.30
                                * * * * *
Peach................................................               0.20
                                * * * * *
------------------------------------------------------------------------

---------------------------------------------------------------------------
* * * * *

[FR Doc. 2010-11301 Filed 5-11-10; 8:45 am]
BILLING CODE 6560-50-S


[Federal Register Volume 80, Number 76 (Tuesday, April 21, 2015)]
[Notices]
[Pages 22175-22176]
[FR Doc No: 2015-09178]

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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
rate filings:
    Docket Numbers: ER10-2721-005.
    Applicants: El Paso Electric Company.
    Description: Non-Material Change in Status Filing of El Paso
Electric Company.
    Filed Date: 4/15/15.
    Accession Number: 20150415-5237.
    Comments Due: 5 p.m. ET 5/6/15.

    Docket Numbers: ER15-1176-001.
    Applicants: South Jersey Energy ISO6, LLC.
    Description: Tariff Amendment per 35.17(b): Amendment to Market-
Based Rate application to be effective 3/5/2015.
    Filed Date: 4/15/15.
    Accession Number: 20150415-5255.
    Comments Due: 5 p.m. ET 5/6/15.

    Docket Numbers: ER15-1177-001.
    Applicants: South Jersey Energy ISO7, LLC.
    Description: Tariff Amendment per 35.17(b): Amendment to Market-
Based Rate Application to be effective 3/5/2015.
    Filed Date: 4/15/15.
    Accession Number: 20150415-5253.
    Comments Due: 5 p.m. ET 5/6/15.

    Docket Numbers: ER15-1178-001.
    Applicants: South Jersey Energy ISO8, LLC.
    Description: Tariff Amendment per 35.17(b): Amendment to Market-
Based Rate Application to be effective 3/5/2015.
    Filed Date: 4/15/15.
    Accession Number: 20150415-5250.
    Comments Due: 5 p.m. ET 5/6/15.

    Docket Numbers: ER15-1510-000.
    Applicants: FirstEnergy Solutions Corp.
    Description: Section 205(d) rate filing per 35.13(a)(2)(iii):
Normal filing to be effective 4/16/2015.
    Filed Date: 4/15/15.
    Accession Number: 20150415-5161.
    Comments Due: 5 p.m. ET 5/6/15.

    Docket Numbers: ER15-1511-000.
    Applicants: Southwest Power Pool, Inc.
    Description: Section 205(d) rate filing per 35.13(a)(2)(iii):
1166R23 Oklahoma Municipal Power Authority NITSA and NOA to be
effective 4/1/2015.
    Filed Date: 4/15/15.
    Accession Number: 20150415-5238.
    Comments Due: 5 p.m. ET 5/6/15.

    Docket Numbers: ER15-1512-000.
    Applicants: Southwest Power Pool, Inc.
    Description: Section 205(d) rate filing per 35.13(a)(2)(iii): 2199
Grand River Dam Authority PTP Notice of Cancellation to be effective 1/
27/2015.
    Filed Date: 4/15/15.
    Accession Number: 20150415-5240.
    Comments Due: 5 p.m. ET 5/6/15.

    Docket Numbers: ER15-1513-000.
    Applicants: Duquesne Conemaugh, LLC.
    Description: Section 205(d) rate filing per 35.13(a)(2)(iii):
Conemaugh Revisions to be effective 1/30/2015.
    Filed Date: 4/15/15.
    Accession Number: 20150415-5275.
    Comments Due: 5 p.m. ET 5/6/15.

    Docket Numbers: ER15-1514-000.
    Applicants: Duquesne Keystone, LLC.
    Description: Section 205(d) rate filing per 35.13(a)(2)(iii):
Revision to MBR to be effective 1/30/2015.
    Filed Date: 4/15/15.
    Accession Number: 20150415-5280.
    Comments Due: 5 p.m. ET 5/6/15.

    Take notice that the Commission received the following electric
securities filings:
    Docket Numbers: ES15-14-000.
    Applicants: NorthWestern Corporation.
    Description: Supplement to March 19, 2015 Application for
Authorization Under Section 204 of the Federal Power Act to Issue
Securities of NorthWestern Corporation.
    Filed Date: 4/15/15.
    Accession Number: 20150415-5155.
    Comments Due: 5 p.m. ET 4/27/15.

    Docket Numbers: ES15-15-000.
    Applicants: ISO New England Inc.
    Description: Application of ISO New England Inc. Under Section 204
of the Federal Power Act For An Order Authorizing the Issuance of
Securities.
    Filed Date: 4/15/15.
    Accession Number: 20150415-5165.
    Comments Due: 5 p.m. ET 5/6/15.

    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 15, 2015.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2015-09178 Filed 4-20-15; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 82, Number 162 (Wednesday, August 23, 2017)]
[Notices]
[Page 40008]
[FR Doc No: 2017-17961]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2013-E-0264; FDA-2013-E-0263; and FDA-2013-E-0218]

Determination of Regulatory Review Period for Purposes of Patent
Extension; RECUVYRA; Affirmation

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of affirmation.

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

DATES: August 23, 2017

FOR FURTHER INFORMATION CONTACT: Joyce Strong, Office of Policy, 10903
New Hampshire Ave., Bldg. 51, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The Food and Drug Administration (FDA) is
affirming the signature date for a notice that appeared in the Federal
Register on August 21, 2017 (82 FR 39587). The document announced FDA's
determination for the regulatory review period for RECUVYRA. The
document published with an incorrect date for the signature. We affirm
that the document was signed on August 15, 2017.

    Dated: August 21, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-17961 Filed 8-21-17; 4:15 pm]
BILLING CODE 4164-01-P


[Federal Register Volume 88, Number 123 (Wednesday, June 28, 2023)]
[Notices]
[Pages 41954-41955]
[FR Doc No: 2023-13761]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #1

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

    Docket Numbers: ER16-355-004; ER16-141-006; ER15-255-005; ER10-
2032-010; ER10-2033-010; ER15-190-021; ER12-2313-007; ER10-1330-009;
ER18-2466-002; ER18-2465-002; ER19-2343-003; ER17-2336-007; ER18-1343-
015.
    Applicants: Carolina Solar Power, LLC, Shoreham Solar Commons LLC,
2018 ESA Project Company, LLC, Potter Road Powerhouse LLC, Federal Way
Powerhouse LLC, North Allegheny Wind, LLC, Laurel Hill Wind Energy,
LLC, Duke Energy Renewable Services, LLC, Duke Energy Ohio, Inc., Duke
Energy Kentucky, Inc., Duke Energy Beckjord Storage, LLC, Conetoe II
Solar, LLC, Colonial Eagle Solar, LLC.
    Description: Supplement to December 20, 2022, Triennial Market
Power Analysis for Northeast Region of Duke MBR Sellers.
    Filed Date: 6/20/23.
    Accession Number: 20230620-5241.
    Comment Date: 5 p.m. ET 7/11/23.

    Docket Numbers: ER22-1731-002.
    Applicants: Southwest Power Pool, Inc.
    Description: Compliance filing: Settlement Compliance Filing of
MRES in Response to May 23 Order to be effective 7/1/2022.
    Filed Date: 6/22/23.
    Accession Number: 20230622-5019.
    Comment Date: 5 p.m. ET 7/13/23.

    Docket Numbers: ER23-1653-001.
    Applicants: Jersey Central Power & Light Company, PJM
Interconnection, L.L.C.
    Description: Tariff Amendment: Jersey Central Power & Light Company
submits tariff filing per 35.17(b): JCPL Responses to Deficiency Letter
in ER23-1653 to be effective 6/17/2023.
    Filed Date: 6/22/23.
    Accession Number: 20230622-5035.
    Comment Date: 5 p.m. ET 7/13/23.

    Docket Numbers: ER23-1730-001.
    Applicants: Pacific Gas and Electric Company.
    Description: Tariff Amendment: Amendment to Q1 2023 Quarterly
Filing of CCSF's WDT SA (SA 275) to be effective 3/31/2023.
    Filed Date: 6/22/23.
    Accession Number: 20230622-5069.
    Comment Date: 5 p.m. ET 7/13/23.

    Docket Numbers: ER23-1876-001.
    Applicants: Public Service Company of Colorado.
    Description: Tariff Amendment: 2023-06-22-TSGT-Fox Run Bndry Agrmt-
743--Errata Filling to be effective 7/11/2023.
    Filed Date: 6/22/23.
    Accession Number: 20230622-5102.
    Comment Date: 5 p.m. ET 7/13/23.

    Docket Numbers: ER23-2207-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Tariff Amendment: Notice of Cancellation of ISA,
Service Agreement No. 5616; Queue No. AD1-143 to be effective 8/23/
2023.
    Filed Date: 6/22/23.
    Accession Number: 20230622-5027.
    Comment Date: 5 p.m. ET 7/13/23.

    Docket Numbers: ER23-2208-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: Original WMPA, Service
Agreement No. 6972; Queue No. AF1-167 to be effective 8/1/2023.
    Filed Date: 6/22/23.
    Accession Number: 20230622-5032.
    Comment Date: 5 p.m. ET 7/13/23.

    Docket Numbers: ER23-2209-000.
    Applicants: Tri-State Generation and Transmission Association, Inc.
    Description: Sec.  205(d) Rate Filing: Initial Filing of Service
Agreement No. 913 to be effective 5/30/2023.
    Filed Date: 6/22/23.
    Accession Number: 20230622-5034.
    Comment Date: 5 p.m. ET 7/13/23.

    Docket Numbers: ER23-2210-000.
    Applicants: El Paso Electric Company.
    Description: Sec.  205(d) Rate Filing: Rate Schedule No. 361 Cost
Reimbursement Agreement between SunZia and El Rio Sol to be effective
5/31/2023.
    Filed Date: 6/22/23.
    Accession Number: 20230622-5046.
    Comment Date: 5 p.m. ET 7/13/23.

    Docket Numbers: ER23-2211-000.
    Applicants: El Paso Electric Company.
    Description: Tariff Amendment: Termination of Service Agreement No.
346, EPE--La Mesa PV I LLC SGIA As Amended to be effective 6/5/2023.
    Filed Date: 6/22/23.
    Accession Number: 20230622-5051.
    Comment Date: 5 p.m. ET 7/13/23.

    Docket Numbers: ER23-2212-000.
    Applicants: New York Independent System Operator, Inc.,
Consolidated Edison Company of New York, Inc.
    Description: Sec.  205(d) Rate Filing: New York Independent System
Operator, Inc. submits tariff filing per 35.13(a)(2)(iii: Con Edison
Proposed FR Template and Protocols in Rate Schedules 10 and 19 to be
effective 8/22/2023.
    Filed Date: 6/22/23.
    Accession Number: 20230622-5080.
    Comment Date: 5 p.m. ET 7/13/23.

    Docket Numbers: ER23-2213-000.
    Applicants: Southwest Power Pool, Inc.
    Description: Sec.  205(d) Rate Filing: 2491R11 Evergy Kansas
Central, Inc. NITSA NOA to be effective 9/1/2023.
    Filed Date: 6/22/23.
    Accession Number: 20230622-5081.
    Comment Date: 5 p.m. ET 7/13/23.

    Docket Numbers: ER23-2214-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: Original ISA and ICSA,
Service Agreement Nos. 6947 and 6948; Queue No. AD2-066 to be effective
8/21/2023.
    Filed Date: 6/22/23.
    Accession Number: 20230622-5099.
    Comment Date: 5 p.m. ET 7/13/23.

    Docket Numbers: ER23-2215-000.
    Applicants: Southwest Power Pool, Inc.
    Description: Sec.  205(d) Rate Filing: 3675R4 Doniphan Electric
Cooperative Assn, Inc. NITSA NOA to be effective 9/1/2023.
    Filed Date: 6/22/23.
    Accession Number: 20230622-5106.
    Comment Date: 5 p.m. ET 7/13/23.

    The filings are accessible in the Commission's eLibrary system
(https://elibrary.ferc.gov/idmws/search/fercgensearch.asp) by querying
the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.

    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: https://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.
    The Commission's Office of Public Participation (OPP) supports
meaningful public engagement and participation in Commission
proceedings. OPP can help members of the public, including landowners,
environmental justice communities, Tribal members and others, access
publicly available information and navigate Commission processes. For
public inquiries and assistance with making filings such as
interventions, comments, or requests for rehearing, the public is
encouraged to contact OPP at<PHONE_NUMBER> or [email protected].

    Dated: June 22, 2023.
Kimberly D. Bose,
Secretary.
[FR Doc. 2023-13761 Filed 6-27-23; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 87, Number 1 (Monday, January 3, 2022)]
[Notices]
[Page 136]
[FR Doc No: 2021-28434]

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SECURITIES AND EXCHANGE COMMISSION

[SEC File No. S7-23-15, OMB Control No. 3235-0763]

Submission for OMB Review; Comment Request; Extension: Rule 304
of Regulation ATS and Form ATS

Upon Written Request, Copies Available From: Securities and Exchange
Commission, Office of FOIA Services, 100 F Street NE, Washington, DC
20549-2736

    Notice is hereby given that pursuant to the Paperwork Reduction Act
of 1995 (``PRA'') (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (``Commission'') has submitted to the Office of Management
and Budget (``OMB'') a request for approval of extension of the
previously approved collection of information provided for in Rule 304
of Regulation ATS (17 CFR 242.304) and Form ATS-N under the Securities
Exchange Act of 1934 (15 U.S.C. 78a et seq.) (``Exchange Act'').
    Regulation ATS provides a regulatory structure for alternative
trading systems. Rule 304 of Regulation ATS provides conditions for NMS
Stock ATSs seeking to rely on the exemption from the definition of
``exchange'' provided by Rule 3a1-1(a) of the Exchange Act, including
to file a Form ATS-N, and for that Form ATS-N to become effective. Form
ATS-N requires NMS Stock ATSs to provide information about their manner
of operations, the broker-dealer operator, and the ATS-related
activities of the broker-dealer operator and its affiliates to comply
with the conditions provided under Rule 304. Form ATS-N promotes more
efficient and effective market operations by providing more
transparency to market participants about the operations of NMS Stock
ATSs and the potential conflicts of interest of the controlling broker-
dealer operator and its affiliates, and helps brokers meet their best
execution obligations to their customers. Operational transparency
rules, including Form ATS-N, are designed to increase competition among
trading centers in regard to order routing and execution quality.
    The Commission staff estimates that entities subject to the
requirements of Rule 304 and Form ATS-N will spend a total of
approximately 2,042 hours a year to comply with the Rule.
    Regulation ATS requires ATSs to preserve any records, for at least
three years, made in the process of complying with the systems
capacity, integrity and security requirements.
    An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information under the PRA unless it
displays a currently valid OMB control number.
    The public may view background documentation for this information
collection at the following website: www.reginfo.gov. Find this
particular information collection by selecting ``Currently under 30-day
Review--Open for Public Comments'' or by using the search function.
Written comments and recommendations for the proposed information
collection should be sent within 30 days of publication of this notice
to (i) www.reginfo.gov/public/do/PRAMain and (ii) David Bottom,
Director/Chief Information Officer, Securities and Exchange Commission,
c/o John R. Pezzullo, 100 F Street NE, Washington, DC 20549, or by
sending an email to: [email protected].

    Dated: December 28, 2021.
J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2021-28434 Filed 12-30-21; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 78, Number 54 (Wednesday, March 20, 2013)]
[Notices]
[Pages 17193-17194]
[FR Doc No: 2013-06336]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP13-91-000]

Gulf South Pipeline Company, LP; Notice of Application

    Take notice that on March 1, 2013, Gulf South Pipeline Company, LP
(Gulf South), 9 Greenway Plaza, Suite 2800, Houston, Texas 77046, filed
in Docket No. CP13-91-000, an application pursuant to section 7(b) of
the Natural Gas Act (NGA), for authorization to abandon by sale or by
inter-corporate transfer to its affiliate, Boardwalk Louisiana
Intrastate Pipeline Company, LLC, approximately 950 miles of lower-
pressure gathering and transmission pipeline, associated meters, one
compressor station, and appurtenant and auxiliary facilities located in
Louisiana, all as more fully set forth in the application which is on
file with the Commission and open for public inspection.
    Any questions regarding the applications should be directed to J.
Kyle Stephens, Vice President, Regulatory Affairs, Gulf South Pipeline
Company, LP, 9 Greenway Plaza, Suite 2800, Houston, Texas 77046, or
call<PHONE_NUMBER>, or by email to<EMAIL_ADDRESS>    Pursuant to section 157.9 of the Commission's rules, 18 CFR 157.9,
within 90 days of this Notice the Commission staff will either:
Complete its environmental assessment (EA) and place it into the
Commission's public record (eLibrary) for this proceeding; or issue a
Notice of Schedule for Environmental Review. If a Notice of Schedule
for Environmental Review is issued, it will indicate, among other
milestones, the anticipated date for the Commission staff's issuance of
the final environmental impact statement (FEIS) or EA for this
proposal. The filing of the EA in the Commission's public record for
this proceeding or the issuance of a Notice of Schedule for
Environmental Review will serve to notify federal and state agencies of
the timing for the completion of all necessary reviews, and the
subsequent need to complete all federal authorizations within 90 days
of the date of issuance of the Commission staff's FEIS or EA.
    There are two ways to become involved in the Commission's review of
this project. First, any person wishing to obtain legal status by
becoming a party to the proceedings for this project should, on or
before the comment date stated below, file with the Federal Energy
Regulatory Commission, 888 First Street NE., Washington, DC 20426, a
motion to intervene in accordance with the requirements of the
Commission's Rules of Practice and Procedure (18 CFR 385.214 or
385.211) and the Regulations under the NGA (18 CFR 157.10). A person
obtaining party status will be placed on the service list maintained by
the Secretary of the Commission and will receive copies of all
documents filed by the applicant and by all other parties. A party must
submit 7 copies of filings made with the Commission and must mail a
copy to the applicant and to every other party in the proceeding. Only
parties to the proceeding can ask for court review of Commission orders
in the proceeding.
    However, a person does not have to intervene in order to have
comments considered. The second way to participate is by filing with
the Secretary of the Commission, as soon as possible, an original and
two copies of comments in support of or in opposition to this project.
The Commission will consider these comments in determining the
appropriate action to be taken, but the filing of a comment alone will
not serve to make the filer a party to the proceeding. The Commission's
rules require that persons filing comments in opposition to the project
provide copies of their protests only to the party or parties directly
involved in the protest.
    Persons who wish to comment only on the environmental review of
this project should submit an original and two copies of their comments
to the Secretary of the Commission. Environmental commentors will be
placed on the Commission's environmental mailing list, will receive
copies of the environmental documents, and will be notified of meetings
associated with the Commission's environmental review process.
Environmental commentors will not be required to serve copies of filed
documents on all other parties. However, the non-party commentors will
not receive copies of all documents filed by other parties or issued by
the Commission (except for the mailing of environmental documents
issued by the Commission) and will not have the right to seek court
review of the Commission's final order.
    The Commission strongly encourages electronic filings of comments,
protests and interventions in lieu of paper using the ``eFiling'' link
at http://www.ferc.gov. Persons unable to file electronically should
submit an original and 7 copies of the protest or intervention to the
Federal Energy Regulatory Commission, 888 First Street NE., Washington,
DC 20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive email
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5:00 p.m. Eastern Time on April 3, 2013.

    Dated: March 13, 2013.
Kimberly D. Bose,
Secretary.
[FR Doc. 2013-06336 Filed 3-19-13; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 76, Number 12 (Wednesday, January 19, 2011)]
[Notices]
[Pages 3143-3144]
[FR Doc No: 2011-1000]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-P-0431]

Determination That ALBAMYCIN (Novobiocin Sodium) Capsule, 250
Milligrams, Was Withdrawn From Sale for Reasons of Safety or
Effectiveness

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) has determined that
ALBAMYCIN (novobiocin sodium) capsule, 250 milligrams (mg) was
withdrawn from sale for reasons of safety or effectiveness. The Agency
will not accept or approve abbreviated new drug applications (ANDAs)
for ALBAMYCIN (novobiocin sodium) capsule, 250 mg.

FOR FURTHER INFORMATION CONTACT: Nancy Hayes, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6244, Silver Spring, MD 20993-0002, 301-
796-3601.

SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price
Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417)
(the 1984 amendments), which authorized the approval of duplicate
versions of drug products approved under an ANDA procedure. ANDA
applicants must, with certain exceptions, show that the drug for which
they are seeking approval contains the same active ingredient in the
same strength and dosage form as the ``listed drug,'' which is a
version of the drug that was previously approved. ANDA applicants do
not have to repeat the extensive clinical testing otherwise necessary
to gain approval of a new drug application (NDA). The only clinical
data required in an ANDA are data to show that the drug that is the
subject of the ANDA is bioequivalent to the listed drug.
    The 1984 amendments include what is now section 505(j)(7) of the
Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)(7)),
which requires FDA to publish a list of all approved drugs. FDA
publishes this list as part of the ``Approved Drug Products With
Therapeutic Equivalence Evaluations,'' which is known generally as the
``Orange Book.'' Under FDA regulations, drugs are removed from the list
if the Agency withdraws or suspends approval of the drug's NDA or

ANDA for reasons of safety or effectiveness or if FDA determines that
the listed drug was withdrawn from sale for reasons of safety or
effectiveness (21 CFR 314.162). Under Sec.  314.161(a)(1) (21 CFR
314.161(a)(1)), the Agency must determine whether a listed drug was
withdrawn from sale for reasons of safety or effectiveness before an
ANDA that refers to that listed drug may be approved. FDA may not
approve an ANDA that does not refer to a listed drug.
    ALBAMYCIN (novobiocin sodium) capsule, 250 mg, is the subject of
NDA 50-339, held by Pfizer, Inc. (Pfizer), and initially approved on
September 4, 1964. ALBAMYCIN is indicated for the treatment of serious
infections due to susceptible strains of Staphylococcus aureus when
other less toxic antibiotics such as the penicillins, cephalosporins,
vancomycin, lincomycin, erythromycin, and the tetracyclines cannot be
used.
    Novobiocin antibiotic drug products were reviewed for efficacy
under the Drug Efficacy Study Implementation (DESI) program. Under this
program, implemented in response to the 1962 amendments to the FD&C Act
requiring demonstration of effectiveness (The Kefauver-Harris
Amendments, Public Law 87-781 (1962)), the National Academy of
Sciences-National Research Council (NAS-NRC) undertook a study of some
4,000 drug formulations to assess the efficacy of the products. Upon
consideration of the findings and recommendations of the NAS-NRC, FDA
set forth in the Federal Register its conclusions and assessment of
whether and under what circumstances the reviewed drug products are
considered ``effective'' for use as required by the FD&C Act.
    In the Federal Register of May 2, 1969 (34 FR 7252), FDA announced
its conclusions following consideration of the findings and
recommendations of the NAS-NRC regarding oral and parenteral forms of
novobiocin including ALBAMYCIN (novobiocin sodium) capsule, 250 mg. The
announcement stated that FDA had concluded that novobiocin is effective
for certain indications and provided labeling guidelines in accordance
with this conclusion. We note, however, that the initial panel review
of a syrup form of novobiocin raised questions, even at that time,
concerning the safety and effectiveness of this antibiotic. The panel
report included the following statement: ``The development of safer and
more effective drugs has virtually eliminated the need for novobiocin.
The majority of the Panel believes that orally administered novobiocin
should be taken off the market.'' Report of the Anti-Infectives Panel,
National Academy of Sciences-National Research Council, Albamycin
Syrup.
    In an annual report received on June 9, 1999, Pharmacia & Upjohn
(now Pfizer, Inc.) notified FDA that ALBAMYCIN (novobiocin sodium)
capsule, 250 mg, was no longer being manufactured. In a letter dated
June 27, 2007, Pfizer, then the current holder of NDA 50-339, notified
FDA that ALBAMYCIN (novobiocin sodium) capsule, 250 mg, had been
discontinued. In the Federal Register of February 11, 2009 (74 FR
6896), FDA announced that it was withdrawing approval of NDA 50-339 in
response to Pfizer's withdrawal request. As a result, ALBAMYCIN
(novobiocin sodium) capsule, 250 mg, was moved to the ``Discontinued
Drug Product List'' section of the Orange Book.
    Crixmore LLC submitted a citizen petition dated July 9, 2008
(Docket No. FDA-2008-P-0431), under 21 CFR 10.30, requesting that the
Agency determine whether ALBAMYCIN (novobiocin sodium) capsule, 250 mg,
was withdrawn from sale for reasons of safety or effectiveness.
    After considering the citizen petition and reviewing Agency
records, FDA has determined under Sec.  314.161 that ALBAMYCIN
(novobiocin sodium) capsule, 250 mg, was withdrawn for reasons of
safety or effectiveness. The petitioner stated that it had identified
no data or other information suggesting that ALBAMYCIN (novobiocin
sodium) capsule, 250 mg, was withdrawn for reasons of safety or
effectiveness and speculated that the discontinuation of this product
was an economic/strategic decision totally unrelated to safety and/or
efficacy. We have carefully reviewed our files for records concerning
the withdrawal of ALBAMYCIN (novobiocin sodium) capsule, 250 mg, from
sale. We have also independently evaluated relevant literature and data
for possible postmarketing adverse events. The literature and adverse
event reports reveal several significant safety concerns. Reported
adverse reactions include relatively common skin reactions, jaundice,
hepatic failure, and blood dyscrasias (neutropenia, anemia, and
thrombocytopenia). The literature also reveals concern about the
development of novobiocin-resistant Staphylococci during treatment, and
a potential for drug interactions. In light of the significant safety
concerns with this product, we conclude that the withdrawal of this
product from the market was on the basis of safety or effectiveness.
    Accordingly, the Agency will remove ALBAMYCIN (novobiocin sodium)
capsule, 250 mg, from the list of drug products published in the Orange
Book. FDA will not accept or approve ANDAs that refer to this drug
product.

    Dated: January 13, 2011.
David Dorsey,
Acting Deputy Commissioner for Policy, Planning and Budget.
[FR Doc. 2011-1000 Filed 1-18-11; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 79, Number 204 (Wednesday, October 22, 2014)]
[Notices]
[Pages 63111-63112]
[FR Doc No: 2014-25117]

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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
rate filings:

    Docket Numbers: ER10-2530-001.
    Applicants: Caprock Wind LLC.
    Description: Notice of Non-Material change in status of Caprock
Wind LLC.
    Filed Date: 10/15/14.
    Accession Number: 20141015-5113.
    Comments Due: 5 p.m. ET 11/5/14.

    Docket Numbers: ER15-91-000.
    Applicants: Brandon Shores LLC.
    Description: Sec.  205(d) rate filing per 35.13(a)(2)(iii): Market-
Based Rate Tariff Revisions to be effective 10/16/2014.
    Filed Date: 10/15/14.
    Accession Number: 20141015-5052.
    Comments Due: 5 p.m. ET 11/5/14.

    Docket Numbers: ER15-92-000.
    Applicants: C.P. Crane LLC.
    Description: Sec.  205(d) rate filing per 35.13(a)(2)(iii): Market-
Based Rate Tariff Revisions to be effective 10/16/2014.
    Filed Date: 10/15/14.
    Accession Number: 20141015-5053.
    Comments Due: 5 p.m. ET 11/5/14.

    Docket Numbers: ER15-93-000.
    Applicants: H.A. Wagner LLC.
    Description: Sec.  205(d) rate filing per 35.13(a)(2)(iii): Market-
Based Rate Tariff Revisions to be effective 10/16/2014.
    Filed Date: 10/15/14.
    Accession Number: 20141015-5054.
    Comments Due: 5 p.m. ET 11/5/14.

    Docket Numbers: ER15-94-000.
    Applicants: Sapphire Power Marketing LLC.
    Description: Sec.  205(d) rate filing per 35.13(a)(2)(iii): Market-
Based Rate Tariff Revisions to be effective 10/16/2014.
    Filed Date: 10/15/14.
    Accession Number: 20141015-5055.
    Comments Due: 5 p.m. ET 11/5/14.

    Docket Numbers: ER15-95-000.
    Applicants: Bayonne Plant Holding, L.L.C.
    Description: Sec.  205(d) rate filing per 35.13(a)(2)(iii): Market-
Based Rate Tariff Revisions to be effective 10/16/2014.
    Filed Date: 10/15/14.
    Accession Number: 20141015-5056.
    Comments Due: 5 p.m. ET 11/5/14.

    Docket Numbers: ER15-96-000.
    Applicants: Camden Plant Holding, L.L.C.
    Description: Sec.  205(d) rate filing per 35.13(a)(2)(iii): Market-
Based Rate Tariff Revisions to be effective 10/16/2014.
    Filed Date: 10/15/14.
    Accession Number: 20141015-5057.
    Comments Due: 5 p.m. ET 11/5/14.

    Docket Numbers: ER15-97-000.
    Applicants: Dartmouth Power Associates Limited Partnership.
    Description: Sec.  205(d) rate filing per 35.13(a)(2)(iii): Market-
Based Rate Tariff Revisions to be effective 10/16/2014.
    Filed Date: 10/15/14.
    Accession Number: 20141015-5058.
    Comments Due: 5 p.m. ET 11/5/14.

    Docket Numbers: ER15-98-000.
    Applicants: Elmwood Park Power, LLC.
    Description: Sec.  205(d) rate filing per 35.13(a)(2)(iii): Market-
Based Rate Tariff Revisions to be effective 10/16/2014.
    Filed Date: 10/15/14.
    Accession Number: 20141015-5059.
    Comments Due: 5 p.m. ET 11/5/14.

    Docket Numbers: ER15-99-000.
    Applicants: Newark Bay Cogeneration Partnership, L.P.
    Description: Sec.  205(d) rate filing per 35.13(a)(2)(iii): Market-
Based Rate Tariff Revisions to be effective 10/16/2014.
    Filed Date: 10/15/14.
    Accession Number: 20141015-5060.
    Comments Due: 5 p.m. ET 11/5/14.

    Docket Numbers: ER15-100-000.
    Applicants: Pedricktown Cogeneration Company LP.
    Description: Sec.  205(d) rate filing per 35.13(a)(2)(iii): Market-
Based Rate Tariff Revisions to be effective 10/16/2014.
    Filed Date: 10/15/14.
    Accession Number: 20141015-5062.
    Comments Due: 5 p.m. ET 11/5/14.

    Docket Numbers: ER15-101-000.
    Applicants: York Generation Company LLC.
    Description: Sec.  205(d) rate filing per 35.13(a)(2)(iii): Market-
Based Rate Tariff Revisions to be effective 10/16/2014.
    Filed Date: 10/15/14.
    Accession Number: 20141015-5064.
    Comments Due: 5 p.m. ET 11/5/14.

    Docket Numbers: ER15-102-000.
    Applicants: TrailStone Power, LLC.
    Description: Sec.  205(d) rate filing per 35.13(a)(2)(iii): Market-
Based Rate Tariff Revisions to be effective 10/16/2014.
    Filed Date: 10/15/14.
    Accession Number: 20141015-5065.
    Comments Due: 5 p.m. ET 11/5/14.

    Docket Numbers: ER15-103-000.
    Applicants: Invenergy Nelson LLC.
    Description: Initial rate filing per 35.12 Application for Market-
Based Rate Authorization to be effective 12/15/2014.
    Filed Date: 10/15/14.
    Accession Number: 20141015-5076.
    Comments Due: 5 p.m. ET 11/5/14.

    Docket Numbers: ER15-103-001.
    Applicants: Invenergy Nelson LLC.
    Description: Tariff Amendment per 35.17(b): Supplement to
Application for Market-Based Rate Authorization to be effective 12/15/
2014.
    Filed Date: 10/15/14.
    Accession Number: 20141015-5082.
    Comments Due: 5 p.m. ET 11/5/14.

    Docket Numbers: ER15-104-000.
    Applicants: Midcontinent Independent System Operator, Inc.
    Description: Sec.  205(d) rate filing per 35.13(a)(2)(iii): 2014-
10-15_SA 1503 NSP-Mankato GIA 1st Rev. (G261) to be effective 10/16/
2014.
    Filed Date: 10/15/14.
    Accession Number: 20141015-5078.
    Comments Due: 5 p.m. ET 11/5/14.

    Docket Numbers: ER15-105-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Sec.  205(d) rate filing per 35.13(a)(2)(iii):
Original Service Agreement No. 3982; Queue No. R52 to be effective 9/
15/2014.
    Filed Date: 10/15/14.
    Accession Number: 20141015-5080.
    Comments Due: 5 p.m. ET 11/5/14.

    Docket Numbers: ER15-106-000.
    Applicants: Trans-Allegheny Interstate Line Company, West Penn
Power Company, The Potomac Edison Company, Monongahela Power Company,
Pennsylvania Electric Company, PJM Interconnection, L.L.C.
    Description: Sec.  205(d) rate filing per 35.13(a)(2)(iii):
TrAILCo, West Penn Power Company, The Potomac Edison Company,
Monongahela Power Company, Pennsylvania Electric Company and PJM
Interconnection, L.L.C. submit Service Agreements to be effective 12/
15/2014.
    Filed Date: 10/15/14.
    Accession Number: 20141015-5083.
    Comments Due: 5 p.m. ET 11/5/14.

    Docket Numbers: ER15-107-000.
    Applicants: Tampa Electric Company.
    Description: Initial rate filing per 35.12 TEC Interconnection
w_Mosaic_South Pierce--RS FERC No. 99 to be effective 8/30/2014.
    Filed Date: 10/15/14.
    Accession Number: 20141015-5120.
    Comments Due: 5 p.m. ET 11/5/14.

    Docket Numbers: ER15-108-000.
    Applicants: Tampa Electric Company.
    Description: Initial rate filing per 35.12 TEC Interconnection
w_Mosaic_Plant City--RS FERC No. 100 to be effective 8/30/2014.

    Filed Date: 10/15/14.
    Accession Number: 20141015-5122.
    Comments Due: 5 p.m. ET 11/5/14.

    Docket Numbers: ER15-109-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Sec.  205(d) rate filing per 35.13(a)(2)(iii):
Original Service Agreement No. 3984; Queue No. R52A to be effective 9/
15/2014.
    Filed Date: 10/15/14.
    Accession Number: 20141015-5124.
    Comments Due: 5 p.m. ET 11/5/14.

    Docket Numbers: ER15-110-000.
    Applicants: Terra-Gen Energy Services, LLC.
    Description: Initial rate filing per 35.12 MBR Application to be
effective 11/15/2014.
    Filed Date: 10/15/14.
    Accession Number: 20141015-5135.
    Comments Due: 5 p.m. ET 11/5/14.

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

    Docket Numbers: RR14-6-001.
    Applicants: North American Electric Reliability Corporation.
    Description: Request of the North American Electric Reliability
Corporation to Submit Revisions to the 2015 Budget and Assessments of
Peak Reliability, Inc. to Reflect Additional Revenues from British
Columbia Hydro and Power Authority.
    Filed Date: 10/14/14.
    Accession Number: 20141014-5501.
    Comments Due: 5 p.m. ET 10/21/14.

    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: October 15, 2014.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2014-25117 Filed 10-21-14; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: May 14, 2009 (Volume 74, Number 92)]
[Notices]
[Page 22739-22740]
[DOCID:fr14my09-30]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2008-0156; FRL-8905-1]

Agency Information Collection Activities; Submission to OMB for
Review and Approval; Comment Request; Use of Consumer Research in
Developing Improved Labeling for Pesticide Products, EPA ICR No.
2297.01, OMB Control No. 2070-NEW

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: In compliance with the Paperwork Reduction Act (44 U.S.C. 3501
et seq.), this document announces that an Information Collection
Request (ICR) has been forwarded to the Office of Management and Budget
(OMB) for review and approval. This is a request for a new collection.
This ICR describes the nature of the information collection and its
estimated burden and cost.

DATES: Additional comments may be submitted on or before June 15, 2009.

ADDRESSES: Submit your comments, referencing docket ID number EPA-HQ-
OPP-2008-0156, to (1) EPA Online to http://www.regulations.gov (our
preferred method), or by mail to: Office of Pesticide Programs (OPP)
Regulatory Public Docket (7502P), 1200 Pennsylvania Ave., NW.,
Washington, DC 20460, and (2) OMB at: Office of Information and
Regulatory Affairs, Office of Management and Budget (OMB), Attention:
Desk Officer for EPA, 725 17th Street, NW., Washington, DC 20503.

FOR FURTHER INFORMATION CONTACT: Cameo Smoot, Field and External
Affairs Division, 7506P, Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460;
telephone number:<PHONE_NUMBER>; fax number:<PHONE_NUMBER>; e-mail
address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: EPA has submitted the following ICR to OMB
for review and approval according to the procedures prescribed in 5 CFR
1320.12. On April 2, 2008 (73 FR 17971), EPA sought comments on this
ICR pursuant to 5 CFR 1320.8(d). EPA received one comment and has
addressed the comment received.
    EPA has established a public docket for this ICR under Docket ID
No. EPA-HQ-OPP-2008-0156, which is available for Online viewing at
http://www.regulations.gov, or in person viewing at the OPP Regulatory
Public Docket in Rm. S-4400, One Potomac Yard (South Building), 2777 S.
Crystal Drive, Arlington, VA. The hours of operation of this Docket
Facility are from 8:30 a.m. to 4 p.m., Monday through Friday, excluding
legal holidays. The Docket telephone number is<PHONE_NUMBER>.
    Use EPA's electronic docket and comment system at http://
www.regulations.gov, to submit or view public comments, access the
index listing of the contents of the docket, and to access those
documents in the docket that are available electronically. Once in the
system, select ``docket search,'' then key in the docket ID number
identified above. Please note that EPA's policy is that public
comments, whether submitted electronically or in paper, will be made
available for public viewing at http://www.regulations.gov as EPA
receives them and without change, unless the comment contains
copyrighted material, Confidential Business Information (CBI), or other
information whose public disclosure is restricted by statute. For
further information about the electronic docket, go to http://
www.regulations.gov.
    Title: Use of Consumer Research in Developing Improved Labeling for
Pesticide Products.
    ICR Numbers: EPA ICR No. 2297.01, OMB Control No. 2070-New.
    ICR Status: This ICR is for a new information collection activity.
An Agency may not conduct or sponsor, and a person is not required to
respond to, a collection of information, unless it displays a currently
valid OMB control number. The OMB control numbers for EPA's regulations
in title 40 of the CFR, after appearing in the Federal Register

when approved, are listed in 40 CFR part 9, are displayed either by
publication in the Federal Register or by other appropriate means, such
as on the related collection instrument or form, if applicable. The
display of OMB control numbers in certain EPA regulations is
consolidated in 40 CFR part 9.
    Abstract: The Environmental Protection Agency (EPA or the Agency)
is proposing to initiate a new information collection activity. EPA
intends to initiate a voluntary information collection for consumer
research involving the conduct of surveys, focus groups and one-on-one
interviews to test various versions of pesticide product labels and
other informational materials developed for the general public. The
pesticide label provides critical information about how to handle and
safely use the pesticide product and avoid harm to human health and the
environment. Every pesticide product must bear a label containing the
information specified by FIFRA as established in EPA's labeling
regulations at 40 CFR 156.10. The purpose for such consumer research is
to identify the consumer's understanding of the information on a
pesticide product label. EPA would use this information to formulate
decisions and policies affecting the labeling of pesticide products.
The ultimate goal of this activity is to assure that the consumer can
effectively use this information to select the pesticide product most
likely to meet their needs and readily understand label instructions
regarding product use.
    The collected information would be used to revise pesticide product
labels and to create other user friendly consumer information
materials. It is anticipated that several surveys, focus groups, and/or
one-on-one interviews would be conducted over the life of the ICR.
    An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information unless it displays a
currently valid OMB control number. The OMB control numbers for EPA's
regulations in 40 CFR are listed in 40 CFR part 9 and are identified on
the form and/or instrument, if applicable.
    Burden Statement: The annual public reporting and recordkeeping
burden for this collection of information is estimated to average 0.89
hours per response. Burden means the total time, effort, or financial
resources expended by persons to generate, maintain, retain, or
disclose or provide information to or for a Federal agency. This
includes the time needed to review instructions; develop, acquire,
install, and utilize technology and systems for the purposes of
collecting, validating, and verifying information, processing and
maintaining information, and disclosing and providing information;
adjust the existing ways to comply with any previously applicable
instructions and requirements; train personnel to be able to respond to
a collection of information; search data sources; complete and review
the collection of information; and transmit or otherwise disclose the
information.
    Respondents/Affected Entities: General Public.
    Estimated Number of Respondents: 2,922.
    Frequency of Response: On occasion.
    Estimated Total Annual Hour Burden: 381.
    Estimated Total Annual Cost: $9,587.
    Changes in the Estimates: None. This is a new ICR request.

    Dated: May 8, 2009.
John Moses,
Director, Collection Strategies Division.
 [FR Doc. E9-11273 Filed 5-13-09; 8:45 am]

BILLING CODE 6560-50-P