[Federal Register Volume 81, Number 186 (Monday, September 26, 2016)]
[Rules and Regulations]
[Pages 65917-65924]
[FR Doc No: 2016-23184]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2015-0791; FRL-9951-60]

Fluopicolide; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation amends tolerances for residues of fluopicolide
in or on potato, processed potato waste and vegetable, tuberous and
corm, subgroup 1C and establishes a tolerance for residues of
fluopicolide in or on potato, granules/flakes. Valent U.S.A.
Corporation requested these tolerances under the Federal Food, Drug,
and Cosmetic Act (FFDCA). This regulation also assigns an expiration
date to existing tolerances for potato, processed potato waste at 1.0
ppm and vegetable, tuberous and corm, subgroup 1C at 0.3 ppm. Lastly,
this regulation establishes a time-limited tolerance on hop, dried
cones. The time-limited tolerance is in response to EPA's granting of
an emergency exemption under the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA). The time-limited tolerance will expire and
revoked on December 31, 2019.

DATES: This regulation is effective September 26, 2016. Objections and
requests for hearings must be received on or before November 25, 2016,
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-2015-0791, 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), West William Jefferson Clinton 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<PHONE_NUMBER>, and the telephone number for the OPP
Docket is<PHONE_NUMBER>. Please review the visitor instructions and
additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Michael Goodis, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main 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. To access the OCSPP
test guidelines referenced in this document electronically, please go
to http://www.epa.gov/ocspp and select ``Test Methods and Guidelines.''

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-2015-0791 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
November 25, 2016. 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-2015-0791, 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 Agency's Action

A. Petitioned-For Tolerances

    In the Federal Register of March 16, 2016 (81 FR 14030) (FRL-9942-
86) 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
5F8414) by Valent U.S.A. Corporation, 1600 Riviera Avenue, Suite 200,
Walnut Creek, CA 94596. The petition requested that 40 CFR 180.627 be
amended by establishing tolerances for residues of the fungicide
fluopicolide, 2,6-dichloro-N-[3-chloro-5-(trifluoromethyl)-2-
pyridylmethyl]-benzamide, in or on potato, chips at 0.1 parts per
million (ppm) and potato, granules/flakes at 0.15 ppm. That document
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. A comment was
received on the notice of filing. EPA's response to this comment is
discussed in Unit IV.C.
    In the Federal Register of May 19, 2016 (81 FR 31581) (FRL-9946-02)
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 5F8414)
by Valent U.S.A. Corporation, 1600 Riviera Avenue, Suite 200, Walnut
Creek, CA 94596. The petition requested that 40 CFR 180.627 be amended
by amending tolerances for residues of the fungicide fluopicolide, 2,6-
dichloro-N-[3-chloro-5-(trifluoromethyl)-2-pyridylmethyl]-benzamide, in
or on potato, processed potato waste at 0.25 ppm and vegetable,
tuberous and corm, subgroup 1C at 0.10 ppm. That document 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.
    Based upon review of the data supporting the petition, EPA is
establishing tolerance levels for potato, processed potato waste and
vegetable, tuberous and corm, subgroup 1C that differ from the petition
requests and is not establishing a tolerance for residues on potato,
chips. The reasons for these changes are explained in Unit IV.D.

B. Tolerance for Use of Pesticide Under Emergency Exemption

    In response to a crisis exemption request filed under section 18 of
the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) on
behalf of the Michigan Department of Agriculture and Rural Development
for the emergency use of fluopicolide to control downy mildew on hops
grown in Michigan, EPA is establishing, pursuant to FFDCA section
408(l)(6), a time-limited tolerance for the use of fluopicolide on hop,
dried cones at 30 ppm with an expiration date of December 31, 2019.
    As part of its evaluation of the emergency exemption application,
EPA assessed the potential risks presented by residues of fluopicolide
on hops. In doing so, EPA considered the safety standard in section
408(b)(2) of FFDCA, and the Agency decided that the necessary tolerance
under section 408(l)(6) of FFDCA would be consistent with the safety
standard and with FIFRA section 18. Consistent with the need to move
quickly on the emergency exemption in order to address an urgent non-
routine situation and to ensure that the resulting food is safe and
lawful, EPA is issuing this tolerance without notice and opportunity
for public comment as provided in section 408(l)(6) of FFDCA. Although
this time-limited tolerance expires and is revoked on December 31,
2019, under section 408(l)(5) of FFDCA, residues of the pesticide not
in excess of the amounts specified in the tolerance remaining in or on
hops after that date will not be unlawful, provided the pesticide was
applied in a manner that was lawful under FIFRA, and the residues do
not exceed a level that was authorized by the time-limited tolerance at
the time of that application. EPA will take action to revoke this time-
limited tolerance earlier if any experience with, scientific data on,
or other relevant information on this pesticide indicate that the
residues are not safe.
    Because this time-limited tolerance is being approved under
emergency conditions, EPA has not made any decisions whether
fluopicolide meets FIFRA's registration requirements for use in or on
hops or whether a permanent tolerance for this use would be
appropriate. Under these circumstances, EPA does not believe that this
time-limited tolerance serves as a basis for registration of
fluopicolide by a State for Special Local Needs under FIFRA section
24(c). Nor does this tolerance serve as the basis for persons in any
State other than Michigan to use this pesticide on hops under FIFRA
sction 18 absent the issuance of an emergency exemption applicable
within that State. For additional information regarding the emergency
exemption for fluopicolide, contact the Agency's Registration Division
at the address provided under FOR FURTHER INFORMATION CONTACT.

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 fluopicolide including exposure
resulting from the tolerances established by this action.
    Fluopicolide shares a metabolite, 2,6-dichlorobenzamide (BAM), with
another active ingredient, dichlobenil. Residues of BAM are considered
to be of regulatory concern, and separate toxicity data and endpoints
for risk assessment have been identified for BAM. Therefore, EPA has
considered the aggregate, or combined risks, from food, water, and non-
occupational exposure resulting from fluopicolide alone and BAM from
all sources for this action. The BAM risk assessment considers residues
resulting from both fluopicolide and dichlobenil uses. However, BAM
residues generated from fluopicolide uses are expected to be
significantly lower than BAM residues from dichlobenil uses.

A. Fluopicolide

    In the Federal Register of August 6, 2014 (79 FR 45688) (FRL-9914-
37), EPA amended tolerances to raise the residue levels of fluopicolide
in or on potato, processed potato waste to 1.0 ppm and vegetable,
tuberous and corm, subgroup 1C to 0.3 ppm. In March of 2016, the EPA
updated the dietary assessment for fluopicolide to account for the use
of fluopicolide on hops under an emergency exemption. The March 2016
assessment considered the higher tolerance levels for potato, processed
potato waste (1.0 ppm) and vegetable, tuberous and corm, subgroup 1C
(0.3 ppm). Since this current action involves lowering the tolerances
for potato, processed potato waste to 0.2 ppm and vegetable, tuberous
and corm, subgroup 1C to 0.09 ppm, the EPA is relying upon the risk
assessments and the findings made for fluopicolide in the August 6,
2014 Federal Register document, as well as an updated dietary risk
assessment conducted for hops to support the lowering of the tolerances
for potato, processed potato waste and vegetable, tuberous and corm,
subgroup 1C.
    The toxicity profile and the points of departure for evaluating
human health for fluopicolide have not changed since the August 6, 2014
rule. EPA conducted a dietary risk assessment to support the Section 18
registration for use of

fluopicolide on hops grown in Michigan in March 2016. The March 2016
assessment assumed the same exposure assumptions for assessing food
exposure as discussed in Unit III.C. of the 2014 rule, where the
analysis assumed 100 percent crop treated (PCT) and tolerance-level
residues for all proposed/registered crops except for field corn/wheat
grain (rotational crop tolerances) and tuberous and corm vegetables.
For these crops, the residues of concern for risk assessment include
metabolites that are not included in the tolerance expression, and the
analysis assumed the highest combined residues from the field trials.
However, the drinking water estimates used in 2016 are higher than
those used in 2014 (24.14 ppb) based on the use of the Pesticide Root
Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS), where
residues in ground water are now estimated to be 103 ppb. The March
2016 assessment resulted in slightly higher chronic dietary exposure
estimates than the August 2014 dietary risk assessment (an increase
from 13% to 14% chronic population-adjusted dose (cPAD)). Since the
2016 dietary risk assessment does not take into account the tolerance
reductions for potato, processed potato waste (from 1.0 ppm to 0.2 ppm)
and vegetable, tuberous and corm, subgroup 1C (from 0.3 ppm to 0.09
ppm) and estimates a higher drinking water concentration (24.14 ppb to
103 ppb), EPA expects the actual chronic dietary exposure estimates to
be lower than 14%. The Agency has not made any new findings concerning
cumulative exposure, nor has it identified any residual uncertainties
to warrant changes to the Agency's August 6, 2014 FQPA safety factor
determination. EPA concludes that reliable data continue to show that
the safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1X based on the same findings found in the
August 6, 2014 rule and supporting documents. Therefore, relying upon
the findings made in the August 6, 2014, Federal Register document and
the 2016 dietary risk assessment, 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 fluopicolide
residues.
    For a detailed discussion of the aggregate risk assessments and
determination of safety for these tolerances, please refer to the
August 6, 2014, Federal Register document and its supporting documents,
available at http://www.regulations.gov in docket ID number EPA-HQ-OPP-
2014-0225, as well as document titled ``Fluopicolide. Section 18
Registration for Application of Fluopicolide to Hops Grown in Michigan.
Dietary Risk Assessment.'' dated March 24, 2016, in docket ID number
EPA-HQ-OPP-2015-0791.
    However, since the August 6, 2014 action relied on a 2008 action
for BAM, the EPA has updated the BAM assessment to revisit the percent
crop treated (PCT) and account for updated food consumption data. EPA's
assessment of exposures and risks associated with BAM follows.

B. BAM

1. 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. The toxicity profile for BAM has not changed since the 2008
assessment EPA conducted for BAM. Specific information on the studies
received and the nature of the adverse effects caused by BAM 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 in
``2,6-Dichlorobenzamide (BAM). 2,6-Dichlorobenzamide (BAM) as a
Metabolite/Degradate of Fluopicolide and Dichlobenil. Human Health Risk
Assessment for Proposed Uses of Rhubarb, Dichlobenil on Caneberries
(Subgroup 13-07A), and Bushberries (Subgroup 13-07B).'' dated June 19,
2008, in docket ID number EPA-HQ-OPP-2007-0604.
2. 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://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.
    A summary of the toxicological endpoints for BAM used for human
risk assessment is discussed in Unit III.B. of the final rule published
in the Federal Register of April 20, 2011 (76 FR 22045) (FRL-8859-9).
3. Exposure Assessment
    a. Dietary exposure from food and feed uses. In evaluating dietary
exposure to BAM, EPA considered exposure of BAM from petitioned-for
tolerances discussed in this document, as well as all existing uses for
both fluopicolide and dichlobenil. EPA assessed dietary exposures from
BAM 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
from a 1-day or single exposure.
    Such effects were identified for BAM. In estimating acute dietary
exposure, EPA used food consumption information from the United States
Department of Agriculture (USDA) National Health and Nutrition
Examination Survey, What We Eat in America, (NHANES/WWEIA). This
dietary survey was conducted from 2003 to 2008. EPA conducted a
partially refined acute dietary exposure assessment for the metabolite
BAM. As to residue levels in food, EPA assumed maximum BAM residue from
either the fluopicolide or dichlobenil field trial data. Further, 100
PCT for all commodities was assumed except apples, blueberries,
cherries, peaches, pears, and raspberries where EPA relied on PCT
estimates based on use of dichlobenil on these commodities;
fluopicolide is not registered for use on these commodities. DEEM
default processing-factors were used for commodities where empirical
processing data were not available.

    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment, EPA used food consumption information from the USDA NHANES/
WWEIA 2003 to 2008 dietary survey. As to residue levels in food, EPA
assumed maximum BAM residue from either fluopicolide or dichlobenil
field trials and, further, the chronic assessment used 100 PCT for all
commodities except apples. DEEM default processing-factors were used
for commodities where empirical processing data were not available.
    iii. Cancer. EPA determines whether quantitative cancer exposure
and risk assessments are appropriate for a food-use pesticide based on
the weight of the evidence from cancer studies and other relevant data.
Cancer risk is quantified using a linear or nonlinear approach. If
sufficient information on the carcinogenic mode of action is available,
a threshold or nonlinear approach is used and a cancer RfD is
calculated based on an earlier noncancer key event. If carcinogenic
mode of action data are not available, or if the mode of action data
determines a mutagenic mode of action, a default linear cancer slope-
factor approach is utilized. EPA has concluded that a nonlinear RfD
approach is appropriate for assessing cancer risk to BAM.
    The carcinogenic potential of BAM has been evaluated in only one
species, the rat. That study showed an increased incidence of
hepatocellular adenomas in high-dose females that was marginally
statistically significant. To be conservative, EPA has assumed that
BAM's potential for carcinogenicity is similar to the parent having the
greatest carcinogenic potential. Fluopicolide has been classified as
not likely to be carcinogenic to humans; EPA classified dichlobenil as
a Group C, possible human carcinogen, but determined that the chronic
dietary risk assessment based on the cPAD would be protective of any
potential cancer effects. EPA has assumed that BAM's carcinogenic
potential is similar to that of dichlobenil, the parent compound having
the greatest carcinogenicity potential. As with dichlobenil, the
chronic dietary risk assessment based on the cPAD is expected to
protect for any potential cancer effects. Cancer risk was assessed
using the same exposure estimates as discussed in Unit III.B.3.a.ii.
    For additional information, refer to the summary of the
toxicological endpoints for BAM used for human risk assessment is
discussed in Unit III.B. of the final rule published in the Federal
Register of April 20, 2011 (76 FR 22045) (FRL-8859-9).
    iv. Anticipated residue and percent crop treated (PCT) information.
For the BAM dietary assessment, EPA used available anticipated residue
levels and PCT information on apples, blueberries, cherries, peaches,
pears, and raspberries where EPA relied on PCT estimates based on use
of dichlobenil; fluopicolide is not registered for use on these
commodities. 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 FFDCA section 408(f)(1) 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 FFDCA section 408(b)(2)(E) and authorized under
FFDCA section 408(f)(1). 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 FFDCA section 408(b)(2)(F), EPA may require
registrants to submit data on PCT.
    In the acute dietary assessment for BAM, the Agency estimated the
PCT from the existing dichlobenil uses as follows: Apple, 2.5%;
blueberry, 2.5%; raspberry, 20%; cherry, 2.5%; peach, 2.5%; pear, 5%.
In the chronic dietary assessment for BAM, the Agency estimated the PCT
from the existing dichlobenil uses as follows: Apple, 1%.
    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 to 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.B.3.a.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 fluopicolide or dichlobenil may be applied in a
particular area.
    b. Dietary exposure from drinking water. The Agency used screening-
level water exposure models in the dietary exposure analysis and risk
assessment for BAM in drinking water. The Agency used estimates of BAM
resulting from the application of dichlobenil, as they were higher than
those resulting from the application of fluopicolide. These simulation
models take into account data on the physical, chemical, and fate/
transport characteristics of BAM. Further information regarding EPA
drinking water models used in pesticide exposure assessment can be
found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.

    Based on the Pesticide Root Zone Model/Exposure Analysis Modeling
System (PRZM/EXAMS) and Screening Concentration in Ground Water (SCI-
GROW) models, the estimated drinking water concentrations (EDWCs) of
BAM resulting from application of dichlobenil for acute exposures are
estimated to be 25.5 parts per billion (ppb) for surface water and 67.4
ppb for ground water. The EDWCs of BAM resulting from application of
dichlobenil for chronic exposures for non-cancer assessments are
estimated to be 10.5 ppb for surface water and 67.4 ppb for ground
water.
    Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For acute and chronic dietary
risk assessment, the water concentration of value 67.4 ppb was used to
assess the contribution to drinking water.
    c. 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).
    Fluopicolide is currently registered for the following uses that
could result in residential exposures: Residential turf grass,
recreational sites, and ornamental plants and trees. EPA assessed
residential exposure to BAM from fluopicolide uses using the following
assumptions: Residential handlers may receive short-term dermal and
inhalation exposure to BAM when mixing, loading, and applying the
fluopicolide formulations. Residential post-application exposure via
the dermal route is likely for adults and children entering treated
lawns or treated gardens and during mowing and golfing activities.
Children may experience exposure via incidental non-dietary ingestion
(i.e., hand-to-mouth, object-to-mouth, and soil ingestion) during post-
application activities on treated turf.
    Residential handler exposure to BAM resulting from the application
of dichlobenil is not expected. While dichlobenil is currently
registered for residential uses on ornamental plants, they are approved
for professional applicator use only. Post-application exposure of
adults and children to dichlobenil and BAM exposure from the use of
dichlobenil products on ornamental plants is expected to be negligible
and, therefore, was not assessed.
    Further information regarding EPA standard assumptions and generic
inputs for residential exposures may be found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/standard-operating-procedures-residential-pesticide.
    d. 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.''
    Unlike other pesticides for which EPA has followed a cumulative
risk approach based on a common mechanism of toxicity, EPA has not made
a common mechanism of toxicity finding as to fluopicolide and any other
substances. Fluopicolide shares a common metabolite, BAM, with
dichlobenil. Quantification of risks for residues of BAM resulting from
fluopicolide and dichlobenil was completed as part of this assessment;
aggregate risks from BAM are not of concern. For the purposes of this
tolerance action, EPA has not assumed that fluopicolide has 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://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides
4. Safety Factor for Infants and Children
    a. 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 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.
    b. Prenatal and postnatal sensitivity. For BAM, there is no
evidence of quantitative susceptibility following in utero and/or
postnatal exposure in the rabbit developmental toxicity study or in the
3-generation rat reproduction study. Qualitative susceptibility was not
observed in the 3-generation reproduction study. Qualitative
susceptibility was observed in the rabbit developmental toxicity study.
Fetal effects (skeletal and visceral anomalies) and late-term abortions
were observed. There is low concern for this qualitative
susceptibility, because the fetal effects and late-term abortions have
been well characterized and occurred at dose levels where significant
maternal toxicity (severe body-weight gain decrements and decreased
food consumption) was observed. Protection of the maternal effects also
protects for any effects that may occur during development. There are
not residual uncertainties concerning prenatal and postnatal toxicity
for BAM.
    c. Conclusion. EPA has retained the 10X FQPA SF for BAM for those
exposure scenarios that do not rely on dichlobenil toxicity data. These
scenarios are acute dietary for the general population (including
infants and children) and females 13-49 years of age, chronic dietary,
and incidental oral non-dietary. Although EPA has developmental,
reproduction, and subchronic and chronic toxicity studies for the
metabolite BAM, and a structure activity analysis indicates EPA has
identified its principal toxicological effects and level of toxicity,
EPA is retaining the FQPA 10X SF due to remaining questions regarding
the systemic neurotoxic potential of BAM (olfactory neurotoxicity) via
the oral route of exposure and the use of a LOAEL in assessing acute
dietary risk for the general population. For the dermal and inhalation
routes of exposures, for which the Agency is relying on dichlobenil
toxicity data, EPA has reduced the FQPA SF for BAM to 1X, based on a
comparison of toxicity via the intraperitoneal route of exposure
showing that higher doses of BAM are needed to induce levels of
olfactory toxicity that are similar to those caused by dichlobenil.
Olfactory toxicity, the most sensitive endpoint, was the endpoint
chosen for these exposure scenarios. Other factors EPA considered in
the FQPA SF decisions for BAM include the following:
    i. To compensate for deficiencies in the toxicology database for
BAM, EPA performed a comparative analysis of the toxicity of BAM and
the parent compounds, dichlobenil and fluopicolide, using the available
animal data and DEREK analysis (Deductive Estimation of Risk from
Existing Knowledge). DEREK is a toxicology application that uses
structure-activity relationships to predict a broad range of
toxicological properties based on a comprehensive analysis of a
compound's molecular structure. Based on the available animal data and
DEREK analyses, BAM does not appear to cause

different organ-specific toxicities compared to fluopicolide and
dichlobenil. The kidney and liver toxicities are common to all three
compounds. With respect to relative toxicity, conclusions from the
evaluation of the animal studies appear to confirm that both
fluopicolide and dichlobenil appear to be more or equally toxic
compared to BAM. A full discussion of EPA's comparative toxicity
analysis of BAM, dichlobenil and fluopicolide can be found at http://www.regulations.gov in the document Comparative Toxicity Using Derek
Analysis for Dichlobenil, Fluopicolide and BAM in docket ID number EPA-
HQ-OPP-2007-0604. Based on the results of the available animal data and
the DEREK analysis, EPA concludes that the safety factors discussed in
the previous paragraph are adequate.
    ii. For BAM, there is no evidence of quantitative susceptibility
following in utero and/or postnatal exposure in the rabbit
developmental toxicity study or in the 3-generation rat reproduction
study. Qualitative susceptibility was not observed in the 3-generation
reproduction study however, qualitative susceptibility was observed in
the rabbit developmental toxicity study. Yet the concern for this
qualitative susceptibility is low because the fetal effects and late-
term abortions have been well characterized and occurred at dose levels
where significant maternal toxicity (severe body-weight gain decrements
and decreased food consumption) was observed. Protection of the
maternal effects also protects for any effects that may occur during
development.
    iii. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were refined using
reliable PCT information and anticipated residue values calculated from
residue field trial results. EPA made conservative (protective)
assumptions in the ground and surface water modeling used to assess
exposure to BAM in drinking water. EPA used similarly conservative
assumptions to assess postapplication exposure of children as well as
incidental oral exposure of toddlers. These assessments will not
underestimate the exposure and risks posed by BAM.
5. 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.
    a. Acute risk. An acute aggregate risk assessment takes into
account acute exposure estimates from dietary consumption of food and
drinking water. Using the exposure assumptions discussed in this unit
for acute exposure, the acute dietary exposure from food and water to
BAM will occupy 26% of the aPAD for females 13 to 49 years old, the
population group receiving the greatest exposure.
    b. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
BAM from food and water will utilize 95% of the cPAD for all Infants
(<1 year old), the population group receiving the greatest exposure.
Based on the explanation in Unit III.B.3.c., regarding residential use
patterns, chronic residential exposure to residues of BAM is not
expected.
    c. Short-term risk. Short-term aggregate exposure takes into
account short-term residential exposure plus chronic exposure to food
and water (considered a background exposure level). Fluopicolide, is
currently registered for uses that could result in short-term
residential exposure to BAM, and the Agency has determined that it is
appropriate to aggregate chronic exposure through food and water with
short-term residential exposures to BAM associated with the application
of fluopicolide. As noted in Unit III.B.3.c above, EPA does not expect
there to be residential exposures to BAM from use of dichlobenil. Using
the exposure assumptions described in this unit for short-term
exposures, EPA has concluded the combined short-term food, water, and
residential exposures result in aggregate MOEs of 3200 for All Infants
(<1 year old) and 5,400 for children 1 to 2 years old. Because EPA's
level of concern for BAM is a MOE of 1,000 or below, these MOEs are not
of concern.
    d. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term residential exposure plus chronic
exposure to food and water (considered a background exposure level). An
intermediate-term adverse effect was identified; however, fluopicolide
is not registered for any use patterns that would result in
intermediate-term residential exposure. Further, fluopicolide and
dichlobenil are not registered for any use patterns that would result
in intermediate-term residential exposure to BAM. 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 fluopicolide and its metabolite, BAM.
    e. Aggregate cancer risk for U.S. population. The Agency considers
the chronic aggregate risk assessment, making use of the cPAD, to be
protective of any aggregate cancer risk. See Unit III.B.5.b, Chronic
risk, above.
    f. 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 residues of fluopicolide and its metabolite, BAM.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (liquid chromatography/tandem mass
spectrometry (LC/MS/MS)) 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. The Codex
has not established an MRL for fluopicolide on the subject commodities.

C. Response to Comments

    EPA received one comment to the Notice of Filing that stated, in
part, that the citizenry of this country do not want to eat any food
items that have been polluted by these toxic chemicals and to deny this
exemption. The Agency understands the commenter's concerns and
recognizes that some individuals believe that pesticides should be
banned on agricultural crops. However, the existing legal framework
provided by section 408 of the Federal Food, Drug, and Cosmetic Act
(FFDCA) states that tolerances may be set when persons seeking such
tolerances or exemptions have demonstrated that the pesticide meets the
safety standard imposed by that statute. This citizen's comment appears
to be directed at the underlying statute and not EPA's implementation
of it; the citizen has made no contention that EPA has acted in
violation of the statutory framework.

D. Revisions to Petitioned-For Tolerances

    EPA revised the tolerance levels based on analysis of the residue
field trial data using the Organization for Economic Cooperation and
Development (OECD) tolerance calculation procedures. Based on
evaluation of the residue data and use of the OECD calculation
procedures, the Agency modified the tolerance for the vegetable,
tuberous and corm, subgroup 1C from the requested level of 0.10 ppm to
0.09 ppm. The Agency also modified the tolerance for potato, processed
potato waste from the requested tolerance level of 0.25 ppm to 0.2 ppm
(0.075 ppm maximum residue x 2.4 processing factor for wet peel). The
EPA did not establish the requested tolerance for potato, chips because
the tolerance for vegetable, tuberous and corm, subgroup 1C (0.09 ppm)
will cover residues in or on potato chips (0.068 ppm estimated
residue).

E. International Trade Considerations

    In this rulemaking, EPA is reducing the tolerances for vegetable,
tuberous and corm, subgroup 1C from 0.3 ppm to 0.09 ppm and potato,
processed potato waste from 1.0 ppm to 0.2 ppm. The petitioner
requested these reductions in order to harmonize tolerances with field
trial data after the tolerances were increased in 2014 to support an
early season soil application to potato, which has since then been
restricted. The reduction is appropriate based on available data and
residue levels resulting from registered use patterns.
    In accordance with the World Trade Organization's (WTO) Sanitary
and Phytosanitary Measures Agreement, EPA notified the WTO of the
request to revise these tolerances on July 19, 2016 as WTO notification
G/SPS/N/USA/2861. In this action, EPA is allowing the existing higher
tolerances to remain in effect for 6 months following the publication
of this rule in order to allow a reasonable interval for producers in
the exporting countries to adapt to the requirements of these modified
tolerances. On March 27, 2017, those existing higher tolerances will
expire, and the new reduced tolerances for vegetable, tuberous and
corm, subgroup 1C and potato, processed potato waste will remain to
cover residues of fluopicolide on those commodities. Before that date,
residues of fluopicolide on those commodities would be permitted up to
the higher tolerance levels; after that date, residues of fluopicolide
on vegetable, tuberous and corm, subgroup 1C and potato, processed
potato waste will need to comply with the new lower tolerance levels.
This reduction in tolerance is not discriminatory; the same food safety
standard contained in the FFDCA applies equally to domestically
produced and imported foods.

V. Conclusion

    Therefore, tolerances are established for residues of fluopicolide,
2,6-dichloro-N-[3-chloro-5-(trifluoromethyl)-2-pyridylmethyl]-
benzamide, in or on vegetable, tuberous and corm, subgroup 1C at 0.09
ppm, potato, processed waste at 0.2 ppm, and potato, granules/flakes at
0.15 ppm. The Agency is adding an expiration date of March 27, 2017 to
the existing tolerances for vegetable, tuberous and corm, subgroup 1C
at 0.3 ppm and potato, processed potato waste at 1.0 ppm. Residues of
fluopicolide will be covered by these higher tolerances until the
expiration date, after which time, they will need to comply with the
lower tolerances being established today. Lastly, this regulation
establishes a time-limited tolerance for residues of fluopicolide in or
on hop, dried cone at 30 ppm.

VI. Statutory and Executive Order Reviews

    This action 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 action has been
exempted from review under Executive Order 12866, this action 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 action 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 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 action 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 action. In addition, this
action does not impose any enforceable duty or contain any unfunded
mandate as described under Title II of the Unfunded Mandates Reform Act
(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 (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: September 13, 2016.
Daniel J. Rosenblatt,
Acting 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.  180.627:
0
a. In the table in paragraph (a), add alphabetically entries for
``Potato, granules/flakes'' and ``Potato, processed potato waste,''
revise the existing entry for ``Potato, processed potato waste,'' and
add an entry for ``Vegetable, tuberous and corm, subgroup 1C''; and
0
b. Revise paragraph (b).
    The additions and revisions read as follows:

Sec.  180.627  Fluopicolide; tolerances for residues.

    (a) * * *

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

                                * * * * *
Potato, granules/flakes.....................................        0.15
Potato, processed potato waste..............................         0.2
Potato, processed potato waste.\1\..........................         1.0

                                * * * * *
Vegetable, tuberous and corm, subgroup 1C...................        0.09
Vegetable, tuberous and corm, subgroup 1C \1\...............         0.3
------------------------------------------------------------------------
\1\ This tolerance expires on March 27, 2017.

    (b) Section 18 emergency exemptions. Time-limited tolerances
specified in the following table are established for residues of the
fluopicolide, including its metabolites and degradates, in or on the
specified agricultural commodities, resulting from use of the pesticide
pursuant to FIFRA section 18 emergency exemptions. Compliance with the
tolerance levels specified below is to be determined by measuring only
fluopicolide [2,6-dichloro-N-[[3-chloro-5-(trifluoromethyl)-2-
pyridinyl]methyl]benzamide] in or on the commodity. The tolerances
expire on the date specified in the table.

------------------------------------------------------------------------
                                 Parts per
          Commodity               million           Expiration date
------------------------------------------------------------------------
Hop, dried cones............              30  December 31, 2019.
------------------------------------------------------------------------

* * * * *
[FR Doc. 2016-23184 Filed 9-23-16; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 84, Number 65 (Thursday, April 4, 2019)]
[Notices]
[Pages 13299-13302]
[FR Doc No: 2019-06553]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0976]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Guidance: Emergency Use Authorization of Medical
Products and Related Authorities

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information, and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on the proposed extension of the collection of
information related to emergency use authorizations by the Agency.

DATES: Submit either electronic or written comments on the collection
of information by June 3, 2019.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before June 3, 2019. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of June 3, 2019. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.

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-2012-N-0976 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Guidance: Emergency Use
Authorization of Medical Products and Related Authorities.'' Received
comments, those filed in a timely manner (see ADDRESSES), 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.

FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Guidance: Emergency Use Authorization of Medical Products and Related
Authorities

OMB Control Number 0910-0595--Extension

    The guidance describes the Agency's policies applicable to the
authorization of the emergency use of certain medical products under
sections 564, 564A, and 564B of the Federal Food, Drug, and Cosmetic
Act (FD&C Act) (21 U.S.C. 360bbb-3, 360bbb-3a, and 360bbb-3b), as
amended or added by the Project BioShield Act of 2004 (Pub. L. 108-
276), the Pandemic and All-Hazards Preparedness Reauthorization Act of
2013 (Pub. L. 113-5), 21st Century Cures Act (Pub. L. 114-255), and
Public Law 115-92 (2017). The FD&C Act permits the Commissioner to
authorize the use of unapproved medical products or unapproved uses of
approved medical products during an emergency declared under section
564 of the FD&C Act. The data to support issuance of an emergency use
authorization (EUA) must demonstrate that, based on the totality of the
scientific evidence available to the Commissioner, including data from
adequate and well-controlled clinical trials (if available), it is
reasonable to believe that the product may be effective in diagnosing,
treating, or preventing a serious or life-threatening disease or
condition (21 U.S.C. 360bbb-3(c)). Although the exact type and amount
of data needed to support an EUA may vary depending on the nature of
the declared emergency and the nature of the candidate product, FDA
recommends that a request for consideration for an EUA include
scientific evidence evaluating the product's safety and effectiveness,
including the adverse event profile for diagnosis, treatment, or
prevention of the serious or life-threatening disease or condition, as
well as data and other information on safety, effectiveness, risks and
benefits, and (to the extent available) alternatives.
    Under section 564 of the FD&C Act, the FDA Commissioner may
establish conditions on the authorization. Section 564(e) requires the
FDA Commissioner (to the extent practicable given the circumstances of
the emergency) to establish certain conditions on an authorization that
the Commissioner finds necessary or appropriate to protect the public
health and permits the FDA Commissioner to establish other conditions
that he or she finds necessary or appropriate to protect the public
health. Conditions authorized by section 564(e) of the FD&C Act
include, for example: Requirements for information dissemination to
healthcare providers or authorized dispensers and product recipients;
adverse event monitoring and reporting; data collection and analysis;
recordkeeping and records access; restrictions on product advertising,
distribution, and administration; and limitations on good manufacturing
practices requirements. Some conditions, the statute specifies, are
mandatory to the extent practicable for authorizations of unapproved
products and discretionary for authorizations of unapproved uses of
approved products. Moreover, some conditions may apply to manufacturers
of an EUA product, while other conditions may apply to any person who
carries out any activity for which

the authorization is issued. Section 564 of the FD&C Act also gives the
FDA Commissioner authority to establish other conditions on an
authorization that he or she finds to be necessary or appropriate to
protect the public health. Additionally, sections 564A and 564B
established streamlined mechanisms to facilitate preparedness and
response activities involving certain FDA-approved products without
requiring FDA to issue an EUA, including expiration date extension
authority.
    For purposes of estimating the annual burden of reporting (table
1), FDA has established four categories of respondents: (1) Those who
file a request for FDA to issue an EUA or a substantive amendment to an
EUA that has previously been issued, assuming that a requisite
declaration under section 564 of the FD&C Act has been made and
criteria for issuance have been met; (2) those who submit a request for
FDA to review information/data (i.e., a pre-EUA package) for a
candidate EUA product or a substantive amendment to an existing pre-EUA
package for preparedness purposes; (3) manufacturers who carry out an
activity related to an unapproved EUA product (e.g., administering
product, disseminating information) who must report to FDA regarding
such activity; and (4) public health authorities (e.g., State, local)
who carry out an activity (e.g., administering product, disseminating
information) related to an unapproved EUA product who must report to
FDA regarding such activity or who submit to FDA an expiration date
extension request for an approved product.
    In some cases, manufacturers directly submit EUA requests. Often a
Federal Government entity (e.g., Centers for Disease Control and
Prevention, Department of Defense) requests that FDA issue an EUA and
submits pre-EUA packages for FDA to review. In many of these cases,
manufacturer respondents inform these requests and submissions, which
are the activities that form the basis of the estimated reporting
burdens. However, in some cases the Federal Government is the sole
respondent; manufacturers do not inform these requests or submissions.
FDA estimates minimal burden when the Federal Government performs the
relevant activities. In addition to variability based on whether there
is an active manufacturer respondent, other factors also inject
significant variability in estimates for annual reporting burdens. A
second factor is the type of product. For example, FDA estimates
greater burden for novel therapeutics than for certain unapproved uses
of approved products. A third significant factor that injects
variability is the type of submission. For example, FDA estimates
greater burden for ``original'' EUA and pre-EUA submissions than for
amendments to them, and FDA estimates minimal burden to issue an EUA
when there is a previously reviewed pre-EUA package or investigational
application. For purposes of estimating the reporting burden, FDA has
calculated the anticipated burden on manufacturers based on the
anticipated types of responses (i.e., estimated manufacturer input),
types of product, and types of submission that comprise the described
reporting activities.
    For purposes of estimating the annual burden of recordkeeping, FDA
has also calculated the anticipated burden on manufacturers and public
health officials associated with administration of unapproved products
authorized for emergency use, recognizing that the Federal Government
will perform much of the recordkeeping related to administration of
such products (table 2). FDA is not calculating any recordkeeping
burden for public health authorities who may need to submit expiration
date extension requests, as these entities already maintain records for
the products that they stockpile, which would include records of any
expiration date request or extension.
    The guidance refers to previously approved collections of
information. These collections are subject to review by the OMB under
the PRA. These collections have been approved as follows: Adverse
experience reporting for biological products is approved under OMB
control number 0910-0308; adverse drug experience reporting is approved
under OMB control number 0910-0230; adverse device experience reporting
is approved under OMB control number 0910-0471; investigational new
drug (IND) application regulations are approved under OMB control
number 0910-0014and investigational device exemption (IDE) reporting is
approved under OMB control number 0910-0078; current good manufacturing
practices for finished pharmaceuticals are approved under OMB control
number 0910-0139, and for devices under OMB control number 0910-0073;
applications for marketing a new drug are approved under OMB control
number 0910-0001, and for biological products under OMB control number.
Any additional burden imposed by this proposed collection would be
minimal.
    FDA estimates the burden of this collection of information as
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                    Average burden
       Type of respondent            Number of     responses per   Total annual    per response     Total hours
                                    respondents     respondent       responses        (hours)
----------------------------------------------------------------------------------------------------------------
Requests to Issue an EUA or a                 12            2.39              29              45           1,305
 Substantive Amendment to an
 Existing EUA...................
FDA Review of a Pre-EUA Package               32            1.79              57              34           1,938
 or an Amendment Thereto........
Manufacturers of an Unapproved                12             5.8              70               2             140
 EUA Product....................
Public Health Authorities;                    30               3              90               2             180
 Unapproved EUA Product.........
Public Health Authorities;                     1               1               1               2               2
 Request for Expiration Date
 Extension......................
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............           3,565
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

                               Table 2--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                    Average burden
       Type of respondent            Number of      records per    Total annual         per         Total hours
                                   recordkeepers   recordkeeper       records      recordkeeping
----------------------------------------------------------------------------------------------------------------
Manufacturers of an Unapproved                12               2              24              25             600
 EUA Product....................
Public Health Authorities;                    30               3              90               3             270
 Unapproved EUA Product.........
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............             870
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Our estimated annual reporting burden for the information
collection reflects an overall increase of 239 hours since our last
request for OMB approval. We attribute this adjustment to an increase
in the number of submissions we received.

    Dated: March 29, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-06553 Filed 4-3-19; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 87, Number 131 (Monday, July 11, 2022)]
[Notices]
[Pages 41163-41164]
[FR Doc No: 2022-14628]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2021-0189]

Agency Information Collection Activities; Renewal of an Approved
Information Collection: Hours of Service (HOS) of Drivers Regulations

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

ACTION: Notice and request for comments.

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

SUMMARY: In accordance with the Paperwork Reduction Act of 1995, the
Federal Motor Carrier Safety Administration (FMCSA) announces its plan
to submit the Information Collection Request (ICR) described below to
the Office of Management and Budget (OMB) for its review and approval
and invites public comment. FMCSA requests approval to renew an ICR
titled, ``Hours of Service (HOS) of Drivers Regulations.'' The HOS
regulations require a motor carrier to install, and requires each of
its drivers subject to the record of duty status (RODS) rule to use, an
electronic logging device (ELD) to report the driver's RODS. The RODS
is critical to FMCSA's safety mission because it helps enforcement
officials determine if commercial motor vehicle (CMV) drivers are
complying with the HOS rules limiting driver on-duty and driving time
and requiring periodic off-duty time.

DATES: Comments on this notice must be received on or before August 10,
2022.

ADDRESSES: Written comments and recommendations for the proposed
information collection should be sent within 30 days of publication of
this notice to www.reginfo.gov/public/do/PRAMain. Find this information
collection by selecting ``Currently under 30-day Review--Open for
Public Comments'' or by using the search function.

FOR FURTHER INFORMATION CONTACT: Ms. Pearlie Robinson, FMCSA Driver and
Carrier Operations Division, DOT, FMCSA, West Building 6th Floor, 1200
New Jersey Avenue SE, Washington, DC 20590,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION:
    Title: Hours of Service (HOS) of Drivers Regulations.
    OMB Control Number: 2126-0001.
    Type of Request: Renewal of an information collection.

    Respondents: Motor Carriers of Property and Passengers, Drivers of
CMVs.
    Estimated Number of Respondents: 4.24 million CMV drivers; 602,542
Motor Carriers.
    Estimated Time per Response: CMV drivers using technology: 2
minutes. Motor Carriers: 2 minutes.
    Expiration Date: July 31, 2022.
    Frequency of Response: Drivers: 240 days per year; Motor carriers
240 days per year.
    Estimated Total Annual Burden: 50.37 million hours.
    Background:
    CMV drivers are limited in how long they may remain in an on-duty
or driving status over specified periods of time. The regulations
outlining those limits are found at 49 CFR part 395 and are known as
the ``HOS regulations.'' The HOS regulations require a motor carrier to
install, and requires each of its drivers subject to the RODS rule to
use, an ELD to report the driver's RODS. These RODS are used to enforce
compliance with the HOS regulations.
    As a condition of receiving certain federal grants, States agree to
adopt and enforce the Federal Motor Carrier Safety Regulations,
including the HOS regulations, as State law. As a result, State
enforcement inspectors use the RODS and supporting documents to
determine whether CMV drivers are complying with the HOS regulations.
In addition, FMCSA uses the RODS during on-site and offsite
investigations of motor carriers and Federal and State courts rely upon
the RODS as evidence of driver and motor carrier violations of the HOS
regulations. This information collection supports DOT's Strategic Goal
of Safety because the information helps the agency ensure the safe
operation of CMVs in interstate commerce.

Renewal of This Information Collection (IC)

    The current IC burden estimate of the HOS rules, approved by OMB on
July 31, 2019, is 41.04 million hours. The expiration date of the
current ICR is July 31, 2022. Through this ICR renewal, FMCSA requests
a revision of the paperwork burden of 2126-0001. The Agency requests an
increase in the burden hours from 41.04 million hours to 50.37 million
hours. The increase is the result of the increase in estimated driver
population as well as the increase in expected industry growth rate for
drivers from 2020 to 2030. Two types of information are collected under
this IC: (1) drivers' RODS commonly referred to as a logbook, and (2)
supporting documents, such as gasoline and toll receipts, that motor
carriers use to verify accuracy of RODS and document expense deductions
for income tax filing purposes. The use of ELDs reduces the driver's
time to input duty status from 6.5 minutes to 2 minutes. This IC
includes only the estimate of 2 minutes for drivers and motor carriers.
    On March 18, 2022, FMCSA published a 60-day notice in the Federal
Register requesting public comments on the proposed revision of this
information collection (87 FR 15488). The Agency received comments
filed jointly by the Truck Safety Coalition (TSC), Citizens for
Reliable and Safe Highways, and Parents Against Tired Truckers and
their volunteers in support of this IC. The TSC wrote, ``Our
organizations strongly support FMCSA's continuation of the collection
Record of Duty Status (RODS) records from Electronic Logging Devices
(ELDs) as well as the supporting documentation, to have the information
needed to inform safety-oriented rulemaking and life-saving enforcement
activities related to HOS.''
    Public Comments Invited: You are asked to comment on any aspect of
this information collection, including: (1) whether the proposed
collection is necessary for the performance of FMCSA's functions; (2)
the accuracy of the estimated burden; (3) ways for the FMCSA to enhance
the quality, usefulness, and clarity of the collected information; and
(4) ways that the burden could be minimized without reducing the
quality of the information collected.
    The Agency will summarize or include your comments in the request
for OMB's clearance of this ICR.

    Issued under the authority of 49 CFR 1.87.
Thomas P. Keane,
Associate Administrator, Office of Research and Registration.
[FR Doc. 2022-14628 Filed 7-8-22; 8:45 am]
BILLING CODE 4910-EX-P


[Federal Register Volume 88, Number 49 (Tuesday, March 14, 2023)]
[Notices]
[Pages 15708-15709]
[FR Doc No: 2023-05288]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Sunshine Act Meeting Notice

    The following notice of meeting is published pursuant to section
3(a) of the government in the Sunshine Act (Pub. L. 94-409), 5 U.S.C.
552b:

Agency Holding Meeting:  Federal Energy Regulatory Commission.

TIME AND DATE:  March 16, 2023, 10 a.m.

PLACE:  Room 2C, 888 First Street NE, Washington, DC 20426.

STATUS:  Open to the public.

MATTERS TO BE CONSIDERED:  Agenda.

* Note--Items listed on the agenda may be deleted without further
notice.

CONTACT PERSON FOR MORE INFORMATION:  Kimberly D. Bose, Secretary.
Telephone<PHONE_NUMBER>.
    For a recorded message listing items stricken from or added to the
meeting, call<PHONE_NUMBER>.
    This is a list of matters to be considered by the Commission. It
does

not include a listing of all documents relevant to the items on the
agenda. All public documents, however, may be viewed on line at the
Commission's website at https://elibrary.ferc.gov/eLibrary/search using
the eLibrary link.

                                                 1099th--Meeting
                                   [Open Meeting; March 16, 2023, 10:00 a.m.]
----------------------------------------------------------------------------------------------------------------
       Item No.                      Docket No.                                    Company
----------------------------------------------------------------------------------------------------------------
                                                 Administrative
----------------------------------------------------------------------------------------------------------------
A-1...................  AD23-1-000.........................  Agency Administrative Matters.
A-2...................  AD23-2-000.........................  Customer Matters, Reliability, Security and Market
                                                              Operations.
A-3...................  AD06-3-000.........................  Market Update.
----------------------------------------------------------------------------------------------------------------
                                                    Electric
----------------------------------------------------------------------------------------------------------------
E-1...................  RD23-3-000.........................  North American Electric Relaibility Corporation.
E-2...................  ER21-2459-001......................  Tenaska Power Services Co.
E-3...................  EL23-31-000........................  Commonwealth Edison Company.
E-4...................  EL22-39-000........................  Public Service Company of Colorado.
E-5...................  EL22-37-000........................  Idaho Power Company.
E-6...................  ES23-23-000........................  PJM Interconnection, L.L.C.
E-7...................  EL15-3-005.........................  City and County of San Francisco v. Pacific Gas and
                        E15-704-027........................   Electric Company.
                                                             Pacific Gas and Electric Company.
E-8...................  EL22-56-001........................  Iowa Coalition for Affordable Transmission v. ITC
                                                              Midwest, LLC.
E-9...................  EL23-8-000.........................  Cubit Power One, Inc. v. Consolidated Edison
                                                              Company of New York, Inc.
E-10..................  ER20-2584-001......................  Transource Maryland, LLC, American Electric Power
                                                              Service Corporation, and PJM Interconnection,
                                                              L.L.C.
E-11..................  ER22-2377-000......................  Black Hills Colorado Electric, LLC.
E-12..................  EL23-14-000........................  Alternative Transmission Inc.
----------------------------------------------------------------------------------------------------------------
                                                       Gas
----------------------------------------------------------------------------------------------------------------
G-1...................  RP22-1105-000......................  Anadarko US Offshore LLC, Murphy Exploration &
                                                              Production Company--USA, Eni Petroleum US LLC, and
                                                              INPEX Americas, Inc.
G-2...................  RP21-1143-001......................  Transcontinental Gas Pipe Line Company, LLC.
----------------------------------------------------------------------------------------------------------------
                                                      Hydro
----------------------------------------------------------------------------------------------------------------
H-1...................  P-2322-073.........................  Brookfield White Pine Hydro LLC.
----------------------------------------------------------------------------------------------------------------
                                                  Certificates
----------------------------------------------------------------------------------------------------------------
C-1...................  CP23-11-000........................  Florida Gas Transmission Company, LLC.
C-2...................  CP21-498-000.......................  Columbia Gas Transmission, LLC.
C-3...................  CP21-113-000.......................  Alliance Pipeline L.P.
C-4...................  CP22-41-000........................  Cameron LNG, LLC.
C-5...................  OMITTED............................
C-6...................  CP21-94-001........................  Transcontinental Gas Pipe Line Company, LLC.
----------------------------------------------------------------------------------------------------------------

    A free webcast of this event is available through the Commission's
website. Anyone with internet access who desires to view this event can
do so by navigating to www.ferc.gov's Calendar of Events and locating
this event in the Calendar. The Federal Energy Regulatory Commission
provides technical support for the free webcasts. Please call (202)
502-8680 or email [email protected] if you have any questions.
    Immediately following the conclusion of the Commission Meeting, a
press briefing will be held in the Commission Meeting Room. Members of
the public may view this briefing in the designated overflow room. This
statement is intended to notify the public that the press briefings
that follow Commission meetings may now be viewed remotely at
Commission headquarters but will not be telecast.

    Issued: March 9, 2023.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2023-05288 Filed 3-10-23; 11:15 am]
BILLING CODE 6717-01-P


[Federal Register: March 16, 2009 (Volume 74, Number 49)]
[Notices]
[Page 11098]
[DOCID:fr16mr09-54]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[ Docket No. PR09-15-000]

Arcadia Gas Storage, LLC; Notice of Petition for Rate Approval

March 9, 2009.
    Take notice that on February 27, 2009, Arcadia Gas Storage, LLC
(Arcadia) filed a petition for rate approval pursuant to section
284.123 of the Commission's regulations requesting that the Commission
approve market-based rates for firm and interruptible natural gas
storage services provided at its natural gas storage facilities in
Bienville Parish, Louisiana, commencing on February 27, 2009.
    Any person desiring to participate in this rate proceeding must
file a motion to intervene or to protest this filing must file in
accordance with Rules 211 and 214 of the Commission's Rules of Practice
and Procedure (18 CFR 385.211 and 385.214). Protests will be considered
by the Commission in determining the appropriate action to be taken,
but will not serve to make protestants parties to the proceeding. Any
person wishing to become a party must file a notice of intervention or
motion to intervene, as appropriate. Such notices, motions, or protests
must be filed on or before the date as indicated below. Anyone filing
an intervention or protest must serve a copy of that document on the
Applicant. Anyone filing an intervention or protest on or before the
intervention or protest date need not serve motions to intervene or
protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://
www.ferc.gov. Persons unable to file electronically should submit an
original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern Time, Tuesday, March 24, 2009.

Kimberly D. Bose,
Secretary.
[FR Doc. E9-5558 Filed 3-13-09; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 85, Number 205 (Thursday, October 22, 2020)]
[Notices]
[Pages 67352-67353]
[FR Doc No: 2020-23357]

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

Food and Drug Administration

[Docket No. FDA-2010-N-0493]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Additional Criteria
and Procedures for Classifying Over-the-Counter Drugs as Generally
Recognized as Safe and Effective and Not Misbranded--Time and Extent
Applications for Nonprescription Drug Products

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

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

DATES: Submit written comments (including recommendations) on the
collection of information by November 23, 2020.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0688. Also include the FDA docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Additional Criteria and Procedures for Classifying Over-the-Counter
Drugs as Generally Recognized as Safe and Effective and Not
Misbranded--Time and Extent Applications for Nonprescription Drug
Products (21 CFR 330.14)

OMB Control Number 0910-0688--Extension

    This information collection supports Agency regulations and
associated guidance. Specifically, FDA regulations in Sec.  330.14 (21
CFR 330.14) establish additional criteria and procedures for
classifying over-the-counter (OTC) drugs as generally recognized as
safe and effective and not misbranded. These regulations state that OTC
drug products introduced into the U.S. market after the OTC drug review
began in 1972 and OTC drug products without any marketing experience in
the United States can be evaluated under the monograph process if the
conditions (e.g., active ingredients) meet certain ``time and extent''
criteria outlined in the regulations. The regulations allow a time and
extent application (TEA) to be submitted to us by any party for our
consideration to include new conditions in the OTC drug monograph
system.
    TEAs must provide evidence described in Sec.  330.14(c)
demonstrating that the condition is eligible for inclusion in the
monograph system. (Section 330.14(d) specifies the number of copies and
address for submission of a TEA.) If a condition is found eligible, any
interested parties can submit safety and effectiveness information as
explained in Sec.  330.14(f). Safety and effectiveness data include the
data and information listed in 21 CFR 330.10(a)(2), a listing of all
serious adverse drug experiences that may have occurred (Sec.
330.14(f)(2)), and an official or proposed compendial monograph (Sec.
330.14(i)).
    Based on our experience with submissions we have received under
Sec.  330.14, we estimate that we will receive two TEAs and two safety
and effectiveness submissions each year and assume that it will take
1,525 hours to prepare a TEA and 2,350 hours to prepare a comprehensive
safety and effectiveness submission.
    We revised our regulations in part 330 (21 CFR part 330) (81 FR
84465, November 23, 2016), thus adding 6 hours to our estimated annual
reporting burden for the information collection. Specifically, Sec.
330.14(j) clarifies the requirements on content and format criteria for
a safety and effectiveness data submission and provides procedures for
our review of the submissions and determination of whether a submission
is sufficiently complete to permit a substantive review.
    Section 330.14(j)(3) describes the process for cases in which we
refuse to file the safety and effectiveness data submission. Under
Sec.  330.14(j)(3), if we refuse to file the submission, we will notify
the sponsor in writing, state the reason(s) for the refusal, and allow
the sponsor 30 days to submit a written request for an informal
conference with us about whether we should file the submission. We
estimate one respondent will submit a request for an informal
conference each year and assume that preparing and submitting each
request will take 1 hour.
    Under Sec.  330.14(j)(4)(iii), the safety and effectiveness data
submission must contain a signed statement that the submission
represents a complete safety and effectiveness data submission and that
the submission includes all the safety and effectiveness data and
information available to the sponsor at the time of the submission,
whether positive or negative. We estimate that two respondents will
submit such signed statements each year and assume that preparing and
submitting each signed statement takes 1 hour.
    Under Sec.  330.14(k)(1), we, in response to a written request from
a sponsor, may withdraw consideration of a TEA submitted under Sec.
330.14(c) or a safety and effectiveness data submission under Sec.
330.14(f). We estimate that one respondent will submit such a request
each year and assume that preparing and submitting the request takes 1
hour.
    Under Sec.  330.14(k)(2), a sponsor may request that FDA not
withdraw consideration of a TEA or safety and effectiveness data
submission. We estimate one respondent will submit such a request each
year and assume that preparing and submitting the request takes 2
hours.
    To assist respondents with the information collection, we developed
the guidance document entitled ``Time and Extent Applications for
Nonprescription Drug Products'' (available from our website at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/time-and-extent-applications-nonprescription-drug-products) issued
consistent with our good guidance practice regulations at 21 CFR
10.115, which provide for comment at any time. The guidance explains
what information an applicant should submit to FDA to

request that a drug product be included in the OTC drug monograph
system and describes the process for submitting that information.
    In the Federal Register of July 30, 2020 (85 FR 45892), we
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
    We estimate the burden of this collection of information as
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                      No. of
    21 CFR part and activity         Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
----------------------------------------------------------------------------------------------------------------
Time and extent application and                2               1               2           1,525           3,050
 submission of information (Sec.
   330.14(c) and (d))...........
Safety and effectiveness data                  2               1               2           2,350           4,700
 (Sec.   330.14(f) and (i)).....
Sponsor request for an informal                1               1               1               1               1
 conference (Sec.
 330.14(j)(3))..................
Sponsor signed statement that                  2               1               2               1               2
 submission is complete (Sec.
 330.14(j)(4))..................
Sponsor request for FDA to                     1               1               1               1               1
 withdraw TEA consideration
 (Sec.   330.14(k)(1))..........
Sponsor request for FDA not to                 1               1               1               2               2
 deem the submission withdrawn
 (Sec.   330.14(k)(2))..........
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............           7,756
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Based on a review of the information collection since our last
request for OMB approval, we have made no adjustments to our burden
estimate.

    Dated: October 14, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-23357 Filed 10-21-20; 8:45 am]
BILLING CODE 4164-01-P