[Federal Register Volume 79, Number 26 (Friday, February 7, 2014)]
[Rules and Regulations]
[Pages 7397-7401]
[FR Doc No: 2014-02568]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2013-0235; FRL-9905-56]

Chlorantraniliprole; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of the
insecticide chlorantraniliprole in or on multiple commodities which are
identified and discussed later in this document. In addition, this
regulation revises existing tolerances in or on papaya, passionfruit,
and spice subgroup 19B, and removes several previously established
tolerances that will be superseded by tolerances established by this
action. 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 February 7, 2014. Objections and
requests for hearings must be received on or before April 8, 2014, 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: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2013-0235, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), EPA West Bldg., Rm. 3334, 1301 Constitution
Ave. NW., Washington, DC 20460-0001. The Public Reading Room is open
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays. The telephone number for the Public Reading Room is (202)
566-1744, and the telephone number for the OPP Docket is (703) 305-
5805. Please review the visitor instructions and additional information
about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Lois Rossi, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone
number:<PHONE_NUMBER>. email 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.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

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 site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 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-2013-0235 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
April 8, 2014. 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 (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2013-0235, by one of
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerances

    In the Federal Register of June 5, 2013 (78 FR 33785) (FRL-9386-2),
EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C.
346a(d)(3), announcing the filing of a pesticide petition (PP 3F8158)
by DuPont Crop Protection, Stine-Haskell Research Center, P.O. Box 30,
Newark, DE 19714. The petition requested that 40 CFR 180.628 be amended
by establishing tolerances for residues of the insecticide
chlorantraniliprole, 3-bromo-N-[4-chloro-2-methyl-6-
[(methylamino)carbonyl]phenyl]-1-(3-chloro-2-pyridinyl)-1H-pyrozole-5-
carboxamide, in or on peanuts at 0.06 parts per million (ppm) and
peanut, hay at 90 ppm. That document referenced a summary of the
petition prepared by DuPont Crop Protection, the registrant, which is
available in the docket, http://www.regulations.gov. There were no
comments received in response to the notice of filing.
    Additionally, in the Federal Register of July 19, 2013 (78 FR
43115) (FRL-9392-9), EPA issued a document pursuant to FFDCA section
408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide
petition (PP 3E8170) by Interregional Research Project Number 4 (IR-4),
500 College Road East, Suite 201 W, Princeton, NJ 08540. The petition
requested that 40 CFR 180.628 be amended by establishing tolerances for
residues of the insecticide chlorantraniliprole in or on fruit, stone,
group 12-12, except cherry, chickasaw

plum, and damson plum at 4.0 ppm; nut, tree, group 14-12 at 0.04 ppm;
papaya at 4.0 ppm; passionfruit at 4.0 ppm; and onion, green, subgroup
3-07B at 3.0 ppm. The petition also requested that tolerances for
spice, subgroup 19B be increased to 40 ppm; and papaya and passionfruit
be increased to 4.0 ppm. IR-4 is seeking to raise the tolerance on
spice, subgroup 19B based on additional residue data on dill seed; IR-4
is seeking to raise the tolerances on papaya and passionfruit as a
result of the request to shorten the existing pre-harvest intervals
(PHIs) for the accompanying use directions for these commodities. That
document referenced a summary of the petition prepared on behalf of IR-
4 by DuPont Crop Protection, the registrant, which is available in the
docket, http://www.regulations.gov. There were no comments received in
response to the notice of filing.
    EPA was petitioned for a tolerance in or on fruit, stone, group 12-
12, except cherry, chickasaw plum, and damson plum at 4.0 ppm; however,
the proposed tolerance was incorrectly transcribed in the Federal
Register Notice of the filing of the petition to propose a tolerance in
or on fruit, stone, group 12, except cherry, chickasaw plum, and damson
plum. However, the summary available in the docket lists stone fruit
group 12-12, except cherry, chickasaw plum, and damson plum. EPA
assessed the correct proposed tolerance on crop group 12-12 rather than
crop group 12, for which there is already an established tolerance.
    Based upon review of the data supporting the petition, EPA has
revised the proposed tolerances for several commodities. The reasons
for these changes are explained in Unit IV.C. Additionally, IR-4 later
withdrew the request to establish a tolerance for tree nut group 14-12.

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 FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA section 408(b)(2)(D), 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 chlorantraniliprole including
exposure resulting from the tolerances established by this action.
EPA's assessment of exposures and risks associated with
chlorantraniliprole follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered their
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.
    Chlorantraniliprole does not exhibit immunotoxicity, neurotoxicity,
carcinogenicity, or developmental toxicity. Additionally, no
mutagenicity concerns were reported in the genotoxicity studies.
    In oral and dermal toxicity studies in rats, minimally increased
microvesiculation of adrenal cortex was observed mostly in males;
however, supporting data demonstrated no effect on the capacity of the
adrenal gland to produce corticosterone following stimulation.
Therefore, adrenal cortex effects observed in rat studies were not
considered adverse.
    Chlorantraniliprole does not exhibit prenatal or postnatal toxicity
as there were no maternal or fetal effects in studies conducted in rats
and rabbits. The relative absence of mammalian hazard may be due in
part to chlorantranilprole's selectivity for insect ryanodine receptor
(RyR) over mammalian counterparts. In short-term mammalian studies, the
most consistent effects are increased liver weights and mild induction
of liver enzymes.
    Chlorantraniliprole is classified as not likely to be carcinogenic
to humans, based on the weight of evidence of the data. No treatment-
related tumors were reported in the submitted chronic and oncogenicity
studies in rats and mice (18-month carcinogenicity study) or in the
subchronic studies in mice, dogs, and rats.
    Specific information on the studies received and the nature of the
adverse effects caused by chlorantraniliprole as well as the no-
observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-
effect-level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in document ``Chlorantraniliprole: Human Health
Risk Assessment for Proposed Uses on Green Onion Subgroup 3-07b, and
Peanut; for the Requests to Update the Crop Groups of Stone Fruit, Tree
Nut, and Spices; to Shorten the Pre-Harvest Intervals for Papaya,
Passionfruit, and Mayhaw; and Evaluation of Condition of Registration
Data on Rice, Coffee, Strawberry, and Tropical Fruits'' at pp. 25-30 in
docket ID number EPA-HQ-OPP-2013-0235.

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 (LOC) 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 chlorantraniliprole
used for human risk assessment is discussed in Unit III.B. of the final
rule published in the Federal Register of July 27, 2011 (76 FR 44815)
(FRL-8875-5).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to chlorantraniliprole, EPA considered exposure under the
petitioned-for tolerances as well as all existing chlorantraniliprole
tolerances in 40 CFR 180.628. EPA assessed dietary exposures from
chlorantraniliprole 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
chlorantraniliprole; 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 United States
Department of Agriculture (USDA) 2003-2008 National Health and
Nutrition Examination Survey, What We Eat in America (NHANES/WWEA). As
to residue levels in food, EPA assumed tolerance-level residues for the
proposed and registered crops, and assumed 100 percent crop treated
(PCT) for all commodities. Where processing data indicated a reduction
(or no increase) in residue upon processing, the residue level of the
raw agricultural commodity (RAC) was used without reduction for the
processed commodity, for example mint oil from spearmint. Where
processing data indicated an increase in residue in the processed
commodity, tolerance-level residues based on tolerances established for
those processed commodities were used, e.g., raisins from grapes.
However, if residues do not concentrate or where processing data
indicated a reduction in residues upon processing, the tolerance for
the RAC is used without reduction and a separate tolerance for the
processed commodity is not needed. Where adequate processing data do
not exist, Dietary Risk Evaluation System (DEEM) default concentration
factors were used.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that chlorantraniliprole does not pose a cancer risk to
humans. Therefore, a dietary exposure assessment for the purpose of
assessing cancer risk is unnecessary.
    iv. Anticipated residue and PCT information. EPA did not use
anticipated residue and/or PCT information in the dietary assessment
for chlorantraniliprole. Tolerance level residues and/or 100 PCT were
assumed for all food commodities.
    2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for chlorantraniliprole in drinking water. These simulation
models take into account data on the physical, chemical, and fate/
transport characteristics of chlorantraniliprole. 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 Pesticide Root Zone Model/Exposure Analysis Modeling
System (PRZM/EXAMS) and PRZM Groundwater (GW) models, the estimated
drinking water concentrations (EDWCs) of chlorantraniliprole for
chronic exposures for non-cancer assessments are estimated to be 39.87
parts per billion (ppb) for surface water and 207 ppb for groundwater.
    Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. No acute dietary risk
assessment was performed because no acute hazard was identified. For
chronic dietary risk assessment, the water concentration value of 207
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).
    Chlorantraniliprole is currently registered for the following uses
that could result in residential exposures: Sod farms/turf, landscape
ornamentals and interiorscapes, and as a termiticide. Residential
exposure is expected to occur for short-term and intermediate-term
durations; however, due to the lack of toxicity identified for short-
and intermediate-term durations via relevant routes of exposure,
residential exposure was not assessed. Further information regarding
EPA standard assumptions and generic inputs for residential exposures
may be found at http://www.epa.gov/pesticides/trac/science/trac6a05.pdf.
    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 chlorantraniliprole to share a common mechanism
of toxicity with any other substances, and chlorantraniliprole does not
appear to produce a toxic metabolite produced by other substances. For
the purposes of this tolerance action, therefore, EPA has assumed that
chlorantraniliprole 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 Web site at
http:[sol][sol]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 were no effects on
prenatal fetal growth or postnatal development up to the limit dose of
1,000 milligrams/kilogram/day (mg/kg/day) in rats or rabbits in the
developmental or 2-generation reproduction studies. Moreover, there
were no treatment related effects on the numbers of litters, fetuses
(live or dead), resorptions, sex ratio, or post-implantation losses.
There were no effects on fetal body weights, skeletal ossification, and
external, visceral, or skeletal malformations or variations.
    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. The toxicity database for chlorantraniliprole is complete.
    ii. There is no indication that chlorantraniliprole is a neurotoxic
chemical and there is no need for a developmental neurotoxicity study
or additional uncertainty factor (UFs) to account for neurotoxicity.

    iii. There is no evidence that chlorantraniliprole results in
increased susceptibility in in utero rats or rabbits in the prenatal
developmental studies or in young rats in the 2-generation reproduction
study.
    iv. There are no residual uncertainties identified in the exposure
databases. The chronic dietary assessment utilized tolerance-level
residues for all crops and assumed that 100 PCT of the proposed and
registered crops were treated with chlorantraniliprole. Default
processing factors were used, as appropriate. EPA made conservative
(protective) assumptions in the ground and surface water modeling used
to assess exposure to chlorantraniliprole in drinking water. Moreover,
there is a lack of toxicity via the dermal route, as well as a lack of
toxicity over the acute-, short- and intermediate-term via the oral
route of exposure. These assessments will not underestimate the
exposure and risks posed by chlorantraniliprole.

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,
chlorantraniliprole 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
chlorantraniliprole from food and water will utilize 6.7% of the cPAD
for children 1-2 years old, the population group receiving the greatest
exposure. Based on the explanation in Unit III.C.3., regarding
residential use patterns, chronic residential exposure to residues of
chlorantraniliprole is not expected.
    3. Short-term and intermediate-term risk. Short-term and
intermediate-term aggregate exposures take into account short-term and
intermediate-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level). Because no
short-term or intermediate-term adverse effects were identified, the
aggregate short-term or intermediate-term risk is the same as the
dietary risk, which will not be greater than the chronic aggregate
risk.
    4. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, chlorantraniliprole is not expected to pose a cancer risk to
humans.
    5. 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 chlorantraniliprole residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology, liquid chromatography mass
spectrometry (LC/MS/MS); Method DuPont-11374, is available to enforce
the tolerance expression.
    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>; email address:
<EMAIL_ADDRESS>
B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
    Codex has not established chlorantraniliprole MRLs for
passionfruit, papaya, peanuts, green onions, or spice commodities. EPA
cannot harmonize the requested tolerance for stone fruit group 12-12,
except cherry, chickasaw plum, and damson plum with the Codex MRL for
stone fruit, because the permitted domestic use on these crops in
accordance with the approved pesticide label results in residue levels
higher than the Codex MRL; EPA will not set tolerances at levels that
could result in legally treated food in the United States bearing
residues in excess of the approved tolerance.

C. Revisions to Petitioned-For Tolerances

    Based on the data supporting the petition, EPA has revised the
following proposed tolerance level: Spice subgroup 19B from 40 ppm to
90. The Agency revised this tolerance level based on analysis of the
residue field trial data using the Organization for Economic
Cooperation and Development tolerance calculation procedures.

V. Conclusion

    Therefore, tolerances are established for residues of
chlorantraniliprole, 3-bromo-N-[4-chloro-2-methyl-6-
[(methylamino)carbonyl]phenyl]-1-(3-chloro-2-pyridinyl)-1H-pyrozole-5-
carboxamide, including its metabolites and degradates, in or on fruit,
stone, group 12-12, except cherry, chickasaw plum, and damson plum at
4.0 ppm; onion, green subgroup 3-07B at 3.0 ppm; peanut, hay at 90 ppm;
and peanut at 0.06 ppm. This regulation additionally revises previously
established tolerances in or on the following commodities: Papaya from
2.0 ppm to 4.0 ppm; passionfruit from 2.0 ppm to 4.0 ppm; and spice
subgroup 19B from 14 ppm to 90 ppm. Finally, this regulation removes
established permanent tolerances or time-limited tolerances for the
indirect or inadvertent residues of chlorantraniliprole in or on fruit,
stone, group 12, except cherry, chickasaw plum, and damson plum at 4.0
ppm; leek at 0.20 ppm; onion, green at 0.20 ppm; onion, welsh at 0.20
ppm; peanut, hay at 0.20 ppm; and shallots, fresh leaves at 0.20 ppm.
    Fruit, stone, group 12, except cherry, chickasaw plum, and damson
plum is being removed because the group 12-12 tolerance being
established, includes all commodities in group 12 at the same tolerance
level. Leek; onion, green; onion, welsh; and shallots, fresh leaves are
being removed because each of these commodities are included in the
subgroup 3-07B, which is being established at 3.0 ppm, a level higher
than the time-limited tolerances for the inadvertent residues of
chlorantraniliprole in or on these commodities.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under FFDCA section 408(d)
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 FFDCA section 408(d), such as the tolerances 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 FFDCA section 408(n)(4). 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) (2 U.S.C. 1501 et seq.).
    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) (15 U.S.C. 272 note).

VII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
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
the rule in the Federal Register. This action 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: January 31, 2014.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.
    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. In Sec.  180.628:
0
a. Remove the entry ``Fruit, stone, group 12, except cherry, chickasaw
plum, and damson plum'' in the table in paragraph (a).
0
b. Add the entries: ``Fruit, stone, group 12-12, except cherry,
chickasaw plum, and damson plum''; ``Onion, green, subgroup 3-07B'';
``Peanut, hay''; and ``Peanut'' to the table in paragraph (a).
0
c. Revise the entries ``Papaya'', ``Passionfruit'', and ``Spice,
subgroup 19B'' in the table in paragraph (a).
0
d. Remove and reserve paragraph (d).
    The amendments read as follows:

Sec.  180.628  Chlorantraniliprole; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------

                                * * * * *
Fruit, stone, group 12-12, except cherry, chickasaw plum,           4.0
 and damson plum...........................................

                                * * * * *
Onion, green, subgroup 3-07B...............................         3.0
Papaya.....................................................         4.0
Passionfruit...............................................         4.0
Peanut.....................................................         0.06
Peanut, hay................................................        90

                                * * * * *
Spice, subgroup 19B........................................        90

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

* * * * *
    (d) Indirect or inadvertent residues. [Reserved]

[FR Doc. 2014-02568 Filed 2-6-14; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: May 24, 2007 (Volume 72, Number 100)]
[Notices]
[Page 29157-29158]
[DOCID:fr24my07-68]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. P-12756-000]

Bost3 Hydroelectric LLC; Notice of Application Accepted for
Filing and Soliciting Motions To Intervene, Protests and Comments

May 17, 2007.
    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection:
    a. Type of Application: Preliminary Permit.
    b. Project No.: 12756-000.
    c. Date filed: December 12, 2006.
    d. Applicant: Bost3 Hydroelectric LLC.
    e. Name of Project: Red River Lock & Dam No. 3 Hydroelectric
Project.
    f. Location: The proposed project would utilize the existing U.S.
Army Corps of Engineers Red River Lock & Dam 3 and would be
located on the Red River in Natchitoches and Grant Parishes, Louisiana.
    g. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791(a)-825(r).
    h. Applicant Contact: Mr. Robert Larson, Bost3 Hydroelectric LLC,
c/o Gray, Plant, Mooty, Mooty, & Bennett, 80 South 8th Street, Suite
500, Minneapolis, MN 55402,<PHONE_NUMBER>.
    i. FERC Contact: Patricia W. Gillis at<PHONE_NUMBER>.
    j. Deadline for filing comments, protests, and motions to
intervene: 60 days from the issuance date of this notice.
    k. All documents (original and eight copies) should be filed with
the Secretary, Federal Energy Regulatory Commission, 888 First Street,
NE., Washington, DC 20426. Please include the project number (P-12756-
000) on any comments, protests, or motions filed.
    The Commission's Rules of Practice and Procedure require all
intervenors filing documents with the Commission to serve a copy of
that document on each person whose name appears on the official service
list for the project. Further, if an intervenor files comments or
documents with the Commission relating to the merits of an issue that
may affect the responsibilities of a particular resource agency, they
must also serve a copy of the document on that resource agency. A copy
of any motion to intervene must also be served upon each representative
of the Applicant specified in the particular application.
    l. Description of Project: The proposed project would use the
existing U. S. Army Corps of Engineers's Red River Lock and Dam No. 3
and consist of: (1) Six proposed penstocks; (2) a proposed powerhouse
containing six generating units with a total installed capacity of 49-
megawatts; (3) a proposed 500-foot-long, 14.7-kilovolt transmission
line; and (4) appurtenant facilities. The proposed project would have
an estimated annual generation of approximately 300-gigawatt-hours. The
applicant plans to sell the generated energy to a local utility.
    m. Location of Application: A copy of the application is available
for inspection and reproduction at the Commission in the Public
Reference Room, located at 888 First Street, NE., Room 2A, Washington,
DC 20426, or by calling<PHONE_NUMBER>. This filing may also be viewed
on the Commission's Web site at http://www.ferc.gov using the

``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field to access the document. For
assistance, call toll-free 1-866-208-3676 or e-mail
<EMAIL_ADDRESS>For TTY, call<PHONE_NUMBER>. A copy is

also available for inspection and reproduction at the address in item h
above.
    n. Individuals desiring to be included on the Commission's mailing
list should so indicate by writing to the Secretary of the Commission.
    o. Competing Preliminary Permit: Anyone desiring to file a
competing application for preliminary permit for a proposed project
must submit the competing application itself, or a notice of intent to
file such an application, to the Commission on or before the specified
comment date for the particular application (see 18 CFR 4.36).
Submission of a timely notice of intent allows an interested person to
file the competing preliminary permit application no later than 30 days
after the specified comment date for the particular application. A
competing preliminary permit application must conform with 18 CFR
4.30(b) and 4.36.
    p. Competing Development Application: Any qualified development
applicant desiring to file a competing development application must
submit to the Commission, on or before a specified comment date for the
particular application, either a competing development application or a
notice of intent to file such an application. Submission of a timely
notice of intent to file a development application allows an interested
person to file the competing application no later than 120 days after
the specified comment date for the particular application. A competing
license application must conform with 18 CFR 4.30(b) and 4.36.
    q. Notice of Intent: A notice of intent must specify the exact
name, business address, and telephone number of the prospective
applicant, and must include an unequivocal statement of intent to
submit, if such an application may be filed, either a preliminary
permit application or a development application (specify which type of
application). A notice of intent must be served on the applicant(s)
named in this public notice.
    r. Proposed Scope of Studies under Permit: A preliminary permit, if
issued, does not authorize construction. The term of the proposed
preliminary permit would be 36 months. The work proposed under the
preliminary permit would include economic analysis, preparation of
preliminary engineering plans, and a study of environmental impacts.
Based on the results of these studies, the Applicant would decide
whether to proceed with the preparation of a development application to
construct and operate the project.
    s. Comments, Protests, or Motions to Intervene: Anyone may submit
comments, a protest, or a motion to intervene in accordance with the
requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211,
.214. In determining the appropriate action to take, the Commission
will consider all protests or other comments filed, but only those who
file a motion to intervene in accordance with the Commission's Rules
may become a party to the proceeding. Any comments, protests, or
motions to intervene must be received on or before the specified
comment date for the particular application.
    t. Filing and Service of Responsive Documents: Any filings must
bear in all capital letters the title ``COMMENTS'', ``PROTEST'',
``MOTION TO INTERVENE'', ``NOTICE OF INTENT'', or ``COMPETING
APPLICATION'', as applicable, and the Project Number of the particular
application to which the filing refers. Any of the above-named
documents must be filed by providing the original and the number of
copies provided by the Commission's regulations to: The Secretary,
Federal Energy Regulatory Commission, 888 First Street, NE.,
Washington, DC 20426. A copy of any motion to intervene must also be
served upon each representative of the Applicant specified in the
particular application.
    u. Agency Comments: Federal, State, and local agencies are invited
to file comments on the described application.

A copy of the application may be obtained by agencies directly from the
applicant. If an agency does not file comments within the time
specified for filing comments, it will be presumed to have no comments.
One copy of an agency's comments must also be sent to the Applicant's
representatives.
    v. Comments, protests and interventions may be filed electronically
via the Internet in lieu of paper. See, 18 CFR 385.2001(a)(1)(iii) and
the instructions on the Commission's Web site at http://www.ferc.gov

under the ``e-Filing'' link.

Kimberly D. Bose,
Secretary.
 [FR Doc. E7-9996 Filed 5-23-07; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register: May 20, 2010 (Volume 75, Number 97)]
[Notices]
[Page 28319]
[DOCID:fr20my10-5201]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Thirteenth Meeting: EUROCAE WG-72: RTCA Special Committee 216:
Aeronautical Systems Security (Joint Meeting)

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of EUROCAE WG-72: RTCA Special Committee 216:
Aeronautical Systems Security (Joint Meeting).

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

SUMMARY: The FAA is issuing this notice to advise the public of a
meeting of EUROCAE WG-72: RTCA Special Committee 216: Aeronautical
Systems Security (Joint Meeting).

DATES: The meeting will be held June 8-11, 2010 starting at 9 a.m. on
the first day and ending by 13:00 on the last day.

ADDRESSES: The meeting will be held at Malakoff (France), 102 rue
Etienne Dolet-92240 Malakoff (4th Floor), hosted by EUROCAE. Point of
Contact: Samira Bezza<EMAIL_ADDRESS>Tel: +33 1 40 92 79 30,
Fax: +33 1 46 55 62 65.

FOR FURTHER INFORMATION CONTACT: RTCA Secretariat, 1828 L Street, NW.,
Suite 805, Washington, DC 20036; telephone<PHONE_NUMBER>; fax (202)
833-9434; Web site http://www.rtca.org.

SUPPLEMENTARY INFORMATION: Pursuant to section 10(a)(2) of the Federal
Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., Appendix 2), notice
is hereby given for a EUROCAE WG-72: RTCA Special Committee 216:
Aeronautical Systems Security (Joint Meeting) meeting.
    The meeting is expected to start at 9:00 on the first day and to
finish by 17:00 each day. It will finish latest by 13:00 on the last
day.
    The main purpose of the meeting is to determine potential joint
Subgroup work based on the new SC-216 TOR, develop agreement between
both groups on the roadmap to potentially jointly publish documents,
continue the specification work and strengthening of links to the Civil
Aviation Authorities.
    Please inform<EMAIL_ADDRESS>and
<EMAIL_ADDRESS>of your intention to attend the meeting.
    The agenda will include:

Day 1

     09h00 to 09h20: Introduction/review of the previous MoM/
Report about publications/Approval of the meeting agenda.
     09h20 to 09h40: WG72 and Group (ED20x) activities status
discussion of implications on joint work.
     09h40 to 10h00: SC-216 and Subgroup activities status and
discussion of implications on joint work.
     10h00 to 10h45: Mapping of SC216 SG's to WG72 ED 20x
Documents:
     Discuss joint SG work plan & schedule based on document(s)
chart.
     10h45 to 11h00: Break.
     11h00 to 11h45: Develop agreement on:
     Either continuing as per previous mode of cooperation.
     Or create a firm joint work plan for mutual document
development.
     Publication Plan: Roadmap and Document layout, discuss
implications.
     11h45 to 12h00: Discussion options to strengthen ties with
CAA's (EASA and others):
     Discuss Response to White Paper: Vision to Lawmakers.
     12h00 to 13h15: Lunch Break.
     13h15 to 14h30: Status of ED201, ED202/ED203, ED204 or
equivalent documents.
     14h15 to 17h00: Split-up sessions:
     ED201: Include transversal topics extracted from other
parts; coordinate details with other parts.
     ED202/203-SG2: Discussion of differences with SC216/SG2;
identify specific terms and glossary concerns; establish common basis
for collaboration or joint work.
     ED204-SG4: Review the SOW of both groups, determine if
full or partly joint work with one resulting document is possible,
identify parts, that can't be joint.

Days 2 & 3

     09h00 to 17h00: Split-up sessions:
     Continuation of work for all documents.

Day 4

     09h00 to 13h00: Plenary Session:
     09:00 to 09:20: Review Status of ED201 session work--What
has been added/modified? Which elements will be dealt with in 2010,
which in a later issue? What is the status of the EFB analysis?
     09:20 to 10:00: Review Status of ED202/ED203-SG2 session
work--What is the status of the documents? Is it reasonable to expect
termination of ED202/DO-TBD work in 2010?
     10:00 to 10:30: Review Status of ED204-SG4 session work--
Is the target audience clear and limited, for which the document is to
be established? Are the expectations of the audience well understood?
How will the work progress, fully joint, partly joint, coordinated w/
two separate documents?
     10:30 to 11:00: Discussion of Glossary: Content and
Publication (separate in ED210 or integrated).
     11:00 to 11:15: Break.
     11:15 to 11:30: Discuss collaboration and associated
topics with other organisations (Arinc, DSWG, ICAO, etc.)
     11:30 to 12:00: Summarize the official Eurocae and RTCA
release/review processes in relation to the planned releases for this
year/early next--verify publication schedule.
     12:00 to 12:30: Future meeting dates & locations;
Expertise to be included; Action Item review.
     12:30 to 12:45: Wrap-up of Meeting, Agreement on
Conclusions and Main Events, Main messages to be disseminated.
    Attendance is open to the interested public but limited to space
availability. With the approval of the chairmen, members of the public
may present oral statements at the meeting. Persons wishing to present
statements or obtain information should contact the person listed in
the FOR FURTHER INFORMATION CONTACT section. Members of the public may
present a written statement to the committee at any time.

    Issued in Washington, DC on May 12, 2010.
Francisco Estrada C.,
RTCA Advisory Committee.
[FR Doc. 2010-12084 Filed 5-19-10; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 84, Number 190 (Tuesday, October 1, 2019)]
[Notices]
[Pages 52114-52115]
[FR Doc No: 2019-21226]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-D-4247]

Patient-Focused Drug Development: Methods To Identify What Is
Important to Patients; Draft Guidance for Industry, Food and Drug
Administration Staff, and Other Stakeholders; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry, FDA staff, and other
stakeholders entitled ``Patient-Focused Drug Development: Methods To
Identify What Is Important to Patients.'' This guidance (Guidance 2) is
the second in a series of four methodological guidance documents that
FDA committed to develop to describe how to collect and submit
information from patients and caregivers to be used for medical product
development and regulatory decision-making.

DATES: Submit either electronic or written comments on the draft
guidance by December 30, 2019 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as
follows.

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2019-D-4247 for ``Patient-Focused Drug Development: Methods To
Identify What Is Important to Patients.'' Received comments will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access

the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of this guidance to the
Division of Drug Information, Center for Drug Evaluation and Research,
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale
Building, 4th Floor, Silver Spring, MD 20993-0002, or to the Office of
Communication, Outreach and Development, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Meghana Chalasani, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 1146, Silver Spring, MD 20993-0002, 240-
402-6525, Fax:<PHONE_NUMBER><EMAIL_ADDRESS>or Stephen
Ripley, Center for Biologics Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver
Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for
industry, FDA staff, and other stakeholders entitled ``Patient-Focused
Drug Development: Methods To Identify What Is Important to Patients.''
This guidance (Guidance 2) is the second in a series of four
methodological patient-focused drug development guidance documents that
FDA committed to develop to describe how stakeholders (patients,
researchers, medical product developers, and others) can collect and
submit information from patients and caregivers to be used for medical
product development and regulatory decision-making. This series of
guidance documents is intended to facilitate the advancement and use of
systematic approaches to collect and use robust and meaningful patient
and caregiver input that can more consistently inform medical product
development and regulatory decision-making. The purpose of Guidance 2
is to present a range of methods and established best research
practices to identify what is important to patients with respect to
burden of disease, burden of treatment, and the benefits and risks in
the management of the patient's disease. The methods and best practices
presented can help elicit relevant information from patients and other
stakeholders, such as how their disease affects their daily lives; what
they find most troublesome; and the challenges, problems, and burdens
of the treatment for the disease.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on ``Patient-
Focused Drug Development: Methods To Identify What Is Important to
Patients.'' It does not establish any rights for any person and is not
binding on FDA or the public. You can use an alternative approach if it
satisfies the requirements of the applicable statutes and regulations.
This guidance is not subject to Executive Order 12866.

II. Additional Information

    Section 3002 of Title III, Subtitle A of the 21st Century Cures Act
(Pub. L. 114-255), directs FDA to develop patient-focused drug
development guidance to address a number of areas, including under
section 3002(c)(2) (methodological approaches that may be used to
develop and identify what is important to patients with respect to
burden of disease, burden of treatment, and the benefits and risks in
the management of the patient's disease).
    In addition, FDA committed to meet certain performance goals under
the sixth authorization of the Prescription Drug User Fee Act. These
goal commitments were developed in consultation with patient and
consumer advocates, healthcare professionals, and other public
stakeholders, as part of negotiations with regulated industry. Section
J.1 of the commitment letter, ``Enhancing the Incorporation of the
Patient's Voice in Drug Development and Decision-Making'' (available at
https://www.fda.gov/media/99140/download), outlines work, including the
development of a series of guidance documents and associated public
workshops to facilitate the advancement and use of systematic
approaches to collect and use robust and meaningful patient and
caregiver input that can more consistently inform drug development,
and, as appropriate, regulatory decision-making.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance
at https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, or https://www.regulations.gov.

    Dated: September 25, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-21226 Filed 9-30-19; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 81, Number 31 (Wednesday, February 17, 2016)]
[Notices]
[Pages 8110-8111]
[FR Doc No: 2016-03112]

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

SECURITIES AND EXCHANGE COMMISSION

Proposed Collection; Comment Request

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

Extension: Rule 15a-6,
    SEC File No. 270-0329, OMB Control No. 3235-0371.

    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'') is soliciting comments on the existing
collection of information provided for in Rule 15a-6, (17 CFR 240.15a-
6), under the Securities Exchange Act of 1934 (15 U.S.C. 78a et seq.).
The Commission plans to submit this existing collection of information
to the Office of Management and Budget (``OMB'') for extension and
approval.
    Rule 15a-6 provides conditional exemptions from the requirement to
register as a broker-dealer pursuant to Section 15 of the Exchange Act
(15 U.S.C. 78o) for foreign broker-dealers that engage in certain
specified activities involving U.S. persons. In particular, Rule 15a-
6(a)(3) provides an exemption from broker-dealer registration for
foreign broker-dealers that solicit and effect transactions with or for
U.S. institutional investors or major U.S. institutional investors
through a registered broker-dealer, provided that the U.S. broker-
dealer, among other things, obtains certain information about, and
consents to service of process from, the personnel of the foreign
broker-dealer involved in such transactions, and maintains certain
records in connection therewith.
    These requirements are intended to ensure (a) that the registered
broker-dealer will receive notice of the identity of, and has reviewed
the background of, foreign personnel who will contact U.S. investors,
(b) that the foreign broker-dealer and its personnel effectively may be
served with process in the event enforcement action is necessary, and
(c) that the Commission has ready access to information concerning
these persons and their U.S. securities activities. Commission staff
estimates that approximately 2,000 U.S. registered

broker-dealers will spend an average of two hours of clerical staff
time and one hour of managerial staff time per year obtaining the
information required by the rule, resulting in a total aggregate burden
of 6,000 hours per year for complying with the rule. Assuming an hourly
cost of $63 \1\ for a compliance clerk and $283 \2\ for a compliance
manager, the resultant total internal labor cost of compliance for the
respondents is $818,000 per year (2,000 entities x ((2 hours/entity x
$63/hour) + (1 hour per entity x $283/hour)) = $818,000).
---------------------------------------------------------------------------

    \1\ The hourly rate used for a compliance clerk was from SIFMA's
Office Salaries in the Securities Industry 2013, modified by
Commission staff to account for an 1,800 hour work-year and
multiplied by 2.93 to account for bonuses, firm size, employee
benefits and overhead.
    \2\ The hourly rate used for a compliance manager was from
SIFMA's Management & Professional Earnings in the Securities
Industry 2013, modified by Commission staff to account for an 1,800
hour work-year and multiplied by 5.35 to account for bonuses, firm
size, employee benefits and overhead.
---------------------------------------------------------------------------

    Written comments are invited on: (a) Whether the proposed
collection of information is necessary for the proper performance of
the functions of the Commission, including whether the information
shall have practical utility; (b) the accuracy of the Commission's
estimates of the burden of the proposed collection of information; (c)
ways to enhance the quality, utility, and clarity of the information
collected; and (d) ways to minimize the burden of the collection of
information on respondents, including through the use of automated
collection techniques or other forms of information technology.
Consideration will be given to comments and suggestions submitted in
writing within 60 days of this publication.
    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.
    Please direct your written comments to: Pamela Dyson, Director/
Chief Information Officer, Securities and Exchange Commission, c/o Remi
Pavlik-Simon, 100 F Street NE., Washington, DC 20549, or send an email
to<EMAIL_ADDRESS>
    Dated: February 10, 2016.
Brent J. Fields,
Secretary.
[FR Doc. 2016-03112 Filed 2-16-16; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 84, Number 151 (Tuesday, August 6, 2019)]
[Notices]
[Pages 38282-38283]
[FR Doc No: 2019-16801]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-3416-EM; Docket ID FEMA-2019-0001]

Louisiana; Emergency and Related Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: This is a notice of the Presidential declaration of an
emergency for the State of Louisiana (FEMA-3416-EM), dated July 11,
2019, and related determinations.

DATES: The declaration was issued July 11, 2019.

FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Notice is hereby given that, in a letter
dated July 11, 2019, the President issued an emergency declaration
under the authority of the Robert T. Stafford Disaster Relief and
Emergency Assistance Act, 42 U.S.C. 5121-5207 (the Stafford Act), as
follows:

    I have determined that the emergency conditions in certain areas
of the State of Louisiana resulting from Tropical Storm Barry
beginning on July 10, 2019, and continuing, are of sufficient
severity and magnitude to warrant an emergency declaration under the
Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42
U.S.C. 5121 et seq. (``the Stafford Act''). Therefore, I declare
that such an emergency exists in the State of Louisiana.
    You are authorized to provide appropriate assistance for
required emergency measures, authorized under title V of the
Stafford Act, to save lives and to protect property and public
health and safety, and to lessen or avert the threat of a
catastrophe in the designated areas. Specifically, you are
authorized to provide assistance for emergency protective measures
(Category B), limited to direct Federal assistance, under the Public
Assistance program.
    Consistent with the requirement that Federal assistance be
supplemental, any Federal funds provided under the Stafford Act for
Public Assistance will be limited to 75 percent of the total
eligible costs. In order to provide Federal assistance, you are
hereby authorized to allocate from funds available for these
purposes such amounts as you find necessary for Federal emergency
assistance and administrative expenses.
    Further, you are authorized to make changes to this declaration
for the approved assistance to the extent allowable under the
Stafford Act.

    The Federal Emergency Management Agency (FEMA) hereby gives notice
that pursuant to the authority vested in the Administrator, Department
of Homeland Security, under Executive Order 12148, as amended, John E.
Long, of FEMA is appointed to act as the Federal Coordinating Officer
for this declared emergency.
    The following areas of the State of Louisiana have been designated
as adversely affected by this declared emergency:

    Acadia, Ascension, Assumption, Avoyelles, Calcasieu, Cameron,
East Baton Rouge, East Feliciana, Iberia, Iberville, Jefferson,
Jefferson Davis, Lafayette, Lafourche, Livingston, Orleans,
Ouachita, Plaquemines, Pointe Coupee, Rapides, St. Bernard, St.
Charles, St. Helena, St. James, St. John the Baptist, St. Landry,
St. Martin, St. Mary, St. Tammany, Tangipahoa, Terrebonne,
Vermilion, Washington, West Baton Rouge, and West Feliciana Parishes
for emergency protective measures (Category B), limited to direct
federal assistance, under the Public Assistance program.

    The following Catalog of Federal Domestic Assistance Numbers
(CFDA) are to be used for reporting and drawing funds: 97.030,
Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis
Counseling; 97.033, Disaster Legal Services; 97.034, Disaster
Unemployment Assistance (DUA); 97.046, Fire Management Assistance
Grant; 97.048, Disaster Housing Assistance to Individuals and
Households In Presidentially Declared Disaster Areas; 97.049,
Presidentially Declared Disaster Assistance--Disaster Housing
Operations for Individuals and Households; 97.050, Presidentially
Declared Disaster Assistance to Individuals and Households--Other
Needs; 97.036, Disaster Grants--Public Assistance (Presidentially
Declared Disasters); 97.039, Hazard Mitigation Grant.

Pete Gaynor,
Acting Administrator, Federal Emergency Management Agency.
[FR Doc. 2019-16801 Filed 8-5-19; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register Volume 88, Number 60 (Wednesday, March 29, 2023)]
[Notices]
[Pages 18538-18539]
[FR Doc No: 2023-06438]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP23-91-000]

WBI Energy Transmission, Inc.; Notice of Request Under Blanket
Authorization and Establishing Intervention and Protest Deadline

    Take notice that on March 9, 2023, WBI Energy Transmission, Inc.
(WBI), 1250 West Century Avenue, Bismarck, North Dakota 58503, filed in
the above referenced docket, a prior notice request to abandon by sale
mainline natural gas facilities located in Big Horn an Washakie
Counties, Wyoming, under authorities granted by its blanket certificate
issued in Docket No. CP82-487-000, all as more fully set forth in the
application which is on file with the Commission and open to public
inspection.
    Specifically, WBI proposes to abandon by sale a portion of its
Worland Cabin Creek mainline, which consist of 4.8 miles of 12-inch-
diameter pipeline and associated facilities on WBI's Line Section 20.
WBI is selling these facilities to Kentex Worland, LLC (Kentex). WBI
states that no service to any customer will be interrupted or otherwise
adversely affected by the abandonment of the facilities described
above. Upon the sale of the facilities to Kentex, the facilities would
not be used to provide FERC-jurisdictional natural gas service. Kentex
intends to utilize the facilities for gas gathering purposes.
    In addition to publishing the full text of this document in the
Federal Register, the Commission provides all interested persons an
opportunity to view and/or print the contents of this document via the
internet through the Commission's Home Page (http://ferc.gov) using the
``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field to access the document. At this time,
the Commission has suspended access to the Commission's Public
Reference Room, due to the proclamation declaring a National Emergency
concerning the Novel Coronavirus Disease (COVID-19), issued by the
President on March 13, 2020. For assistance, contact FERC at
[email protected] or call toll-free,<PHONE_NUMBER> or TYY,
(202) 502-8659.
    Any questions regarding this prior notice request should be
directed to Lori Myerchin, Director, Regulatory Affairs and
Transportation Services, WBI Energy Transmission, Inc., 1250 West
Century Avenue, Bismarck, North Dakota 58503, at<PHONE_NUMBER>, or by
email at [email protected].

Public Participation

    There are three ways to become involved in the Commission's review
of this project: you can file a protest to the project, you can file a
motion to intervene in the proceeding, and you can file comments on the
project. There is no fee or cost for filing protests, motions to
intervene, or comments. The deadline for filing protests, motions to
intervene, and comments is 5:00 p.m. Eastern Time on May 19, 2023. How
to file protests, motions to intervene, and comments is explained
below.

Protests

    Pursuant to section 157.205 of the Commission's regulations under
the NGA,\1\ any person \2\ or the Commission's staff may file a protest
to the request. If no protest is filed within the time allowed or if a
protest is filed and then withdrawn within 30 days after the allowed
time for filing a protest, the proposed activity shall be deemed to be
authorized effective the day after the time allowed for protest. If a
protest is filed and not withdrawn within 30 days after the time
allowed for filing a protest, the instant request for authorization
will be considered by the Commission.
---------------------------------------------------------------------------

    \1\ 18 CFR 157.205.
    \2\ Persons include individuals, organizations, businesses,
municipalities, and other entities. 18 CFR 385.102(d).
---------------------------------------------------------------------------

    Protests must comply with the requirements specified in section
157.205(e) of the Commission's regulations,\3\ and must be submitted by
the protest deadline, which is May 19, 2023. A protest may also serve
as a motion to intervene so long as the protestor states it also seeks
to be an intervenor.
---------------------------------------------------------------------------

    \3\ 18 CFR 157.205(e).
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Interventions

    Any person has the option to file a motion to intervene in this
proceeding. Only intervenors have the right to request rehearing of
Commission orders issued in this proceeding and to subsequently
challenge the Commission's orders in the U.S. Circuit Courts of Appeal.
    To intervene, you must submit a motion to intervene to the
Commission in accordance with Rule 214 of the Commission's Rules of
Practice and Procedure \4\ and the regulations under the NGA \5\ by the
intervention deadline for the project, which is May 19, 2023. As
described further in Rule 214, your motion to intervene must state, to
the extent known, your position regarding the proceeding, as well as
your interest in the proceeding. For an individual, this could include
your status as a landowner, ratepayer, resident of an impacted
community, or recreationist. You do not need to have property directly
impacted by the project in order to intervene. For more information
about motions to intervene, refer to the FERC website at https://www.ferc.gov/resources/guides/how-to/intervene.asp.
---------------------------------------------------------------------------

    \4\ 18 CFR 385.214.
    \5\ 18 CFR 157.10.
---------------------------------------------------------------------------

    All timely, unopposed motions to intervene are automatically
granted by operation of Rule 214(c)(1). Motions to intervene that are
filed after the intervention deadline are untimely and may be denied.
Any late-filed motion to intervene must show good cause for being late
and must explain why the time limitation should be waived and provide
justification by reference to factors set forth in Rule 214(d) of the
Commission's Rules and Regulations. A person obtaining party status
will be placed on the service list maintained by the Secretary of the
Commission and will receive copies (paper or electronic) of all
documents filed by the applicant and by all other parties.

Comments

    Any person wishing to comment on the project may do so. The
Commission considers all comments received about the project in
determining the appropriate action to be taken. To ensure that your
comments are timely and properly recorded, please submit your comments
on or before May 19, 2023. The filing of a comment alone will not serve
to make the filer a party to the proceeding. To become a party, you
must intervene in the proceeding.

How To File Protests, Interventions, and Comments

    There are two ways to submit protests, motions to intervene, and
comments. In both instances, please reference the Project docket number
CP23-91-000 in your submission.
    (1) You may file your protest, motion to intervene, and comments by
using the Commission's eFiling feature, which is located on the
Commission's website (www.ferc.gov) under the link to Documents and
Filings. New eFiling users must first create an account by clicking on
``eRegister.'' You will be asked to select the type of filing you are
making; first select General'' and then select ``Protest'',
``Intervention'', or ``Comment on a Filing''; or \6\
---------------------------------------------------------------------------

    \6\ Additionally, you may file your comments electronically by
using the eComment feature, which is located on the Commission's
website at www.ferc.gov under the link to Documents and Filings.
Using eComment is an easy method for interested persons to submit
brief, text-only comments on a project.

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

    (2) You can file a paper copy of your submission by mailing it to
the address below. Your submission must reference the Project docket
number CP23-91-000.
    To mail via USPS, use the following address: Kimberly D. Bose,
Secretary, Federal Energy Regulatory Commission, 888 First Street NE,
Washington, DC 20426.
    To send via any other courier, use the following address: Kimberly
D. Bose, Secretary, Federal Energy Regulatory Commission, 12225 Wilkins
Avenue, Rockville, Maryland 20852.
    The Commission encourages electronic filing of submissions (option
1 above) and has eFiling staff available to assist you at (202) 502-
8258 or [email protected]
    Protests and motions to intervene must be served on the applicant
either by mail at: Lori Myerchin, Director, Regulatory Affairs and
Transportation Services, WBI Energy Transmission, Inc., 1250 West
Century Avenue, Bismarck, North Dakota 58503, or by email at
[email protected]. Any subsequent submissions by an intervenor
must be served on the applicant and all other parties to the
proceeding. Contact information for parties can be downloaded from the
service list at the eService link on FERC Online.

Tracking the Proceeding

    Throughout the proceeding, additional information about the project
will be available from the Commission's Office of External Affairs, at
(866) 208-FERC, or on the FERC website at FERC.gov using the
``eLibrary'' link as described above. The eLibrary link also provides
access to the texts of all formal documents issued by the Commission,
such as orders, notices, and rulemakings.
    In addition, the Commission offers a free service called
eSubscription which allows you to keep track of all formal issuances
and submittals in specific dockets. This can reduce the amount of time
you spend researching proceedings by automatically providing you with
notification of these filings, document summaries, and direct links to
the documents. For more information and to register, go to
www.ferc.gov/docs-filing/esubscription.asp.

    Dated: March 20, 2023.
Kimberly D. Bose,
Secretary.
[FR Doc. 2023-06438 Filed 3-28-23; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 86, Number 193 (Friday, October 8, 2021)]
[Notices]
[Page 56284]
[FR Doc No: 2021-22058]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID FEMA-2007-0008]

National Advisory Council; Meeting

AGENCY: Federal Emergency Management Agency, Department of Homeland
Security.

ACTION: Committee Management; Notice of open Federal Advisory Committee
meeting.

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SUMMARY: The Federal Emergency Management Agency's National Advisory
Council (NAC) will meet November 2 and 3, 2021. The meeting will be
open to the public through virtual means.

DATES: The NAC will meet 8:30 a.m. and 5 p.m. Eastern Time (ET) on
Tuesday, November 2, 2021 and Wednesday, November 3, 2021. Please note
that the meeting may close early if the NAC has completed its business.

ADDRESSES: Anyone who wishes to participate must register with FEMA in
advance by providing their name, official title, organization,
telephone number, and email address to the person listed in the FOR
FURTHER INFORMATION CONTACT caption below by 5 p.m. ET Friday, October
29, 2021. Members of the public are urged to provide written comments
on the issues to be considered by the NAC. The topic areas are
indicated in the SUPPLEMENTARY INFORMATION caption below. Any written
comments must be submitted and received by 5 p.m. ET on October 29,
2021, identified by Docket ID FEMA-2007-0008, and submitted by the
following method: Federal eRulemaking Portal at http://www.regulations.gov. Follow the instructions for submitting comments.
    Instructions for Submitting Comments: All submissions must include
the words ``Federal Emergency Management Agency'' and the docket number
(Docket ID FEMA-2007-0008) for this action. Comments received,
including any personal information provided, will be posted without
alteration at http://www.regulations.gov. For access to the docket or
to read comments received by the NAC, go to http://www.regulations.gov,
and search for Docket ID FEMA-2007-0008.
    Public comment periods will be held on Tuesday, November 2, 2021,
from 9:45 a.m. to 10:00 a.m.; and Wednesday, November 3, 2021 from 8:45
a.m. to 9:00 a.m. ET. All speakers must register in advance of the
meeting to make remarks during the public comment period and must limit
their comments to three minutes. Comments should be addressed to the
NAC. Any comments not related to the agenda topics will not be
considered. To register to make remarks during the public comment
period, contact the person listed in the FOR FURTHER INFORMATION
CONTACT caption below by 5 p.m. ET, Friday, October 29, 2021. Please
note that the public comment period may end before the time indicated,
following the last call for comments.
    Reasonable accommodations are available for people with
disabilities. To request a reasonable accommodation, contact the person
listed in the FOR FURTHER INFORMATION CONTACT caption below as soon as
possible. Last minute requests will be accepted but may not be possible
to fulfill.

FOR FURTHER INFORMATION CONTACT: Rob Long, Designated Federal Officer,
Office of the National Advisory Council, Federal Emergency Management
Agency, 500 C Street SW, Washington, DC 20472-3184,<PHONE_NUMBER>, and
email<EMAIL_ADDRESS>The NAC website is http://www.fema.gov/national-advisory-council.

SUPPLEMENTARY INFORMATION: Notice of this meeting is given under the
Federal Advisory Committee Act, 5 U.S.C. Appendix.
    The NAC advises the FEMA Administrator on all aspects of emergency
management. The NAC incorporates input from State, local, Tribal, and
territorial governments, and the private sector in the development and
revision of FEMA plans and strategies. The NAC includes a cross-section
of officials, emergency managers, and emergency response providers from
State, local, Tribal, and territorial governments, the private sector,
and nongovernmental organizations.
    Agenda: On Tuesday, November 2, 2021, NAC subcommittees will
present to the full NAC their recommendations on the topics of equity,
potential improvements to the public and individual assistance
programs, workforce support, risk-informed decision making, and ideas
of restructuring FEMA. On Wednesday, November 3, 2021, the NAC will
discuss and consider with selected experts and leadership how to
approach considering issues of equity, climate adaptation and readiness
in 2022.
    The full agenda and any related documents for this meeting will be
available by Friday, October 29, 2021, by contacting the person listed
in the FOR FURTHER INFORMATION CONTACT caption above.

Deanne Criswell,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2021-22058 Filed 10-7-21; 8:45 am]
BILLING CODE 9111-48-P