[Federal Register Volume 85, Number 224 (Thursday, November 19, 2020)]
[Notices]
[Page 73701]
[FR Doc No: 2020-25559]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket Nos. EL21-16-000]

Wisconsin Electric Power Company; Notice of Petition for
Declaratory Order

    Take notice that on November 13, 2020, pursuant to Rule 207 of the
Federal Energy Regulatory Commission's (Commission) Rules of Practice
and Procedure, 18 CFR 385.207 (2020),\1\ Wisconsin Electric Power
Company (Petitioner), filed a petition for declaratory order (Petition)
requesting that the Commission find that their Market Rate Tariff
Service Agreement with Cloverland Electric Cooperative \2\, does not
impede the Commission's regulations and policies concerning the Public
Utility Regulatory Policies Act of 1978 (PURPA), as more fully
explained in the petition.
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    \1\ As required by Rule 381.302(a), 18 CFR 381.302(a) (2020),
and the Commission's Annual Update of Filing Fees, 85 FR 1,102 (Jan.
9, 2020), Wisconsin Electric has submitted the required filing fee
of $30,060.
    \2\ Edison Sault Electric Company, LLC (ESE) is also listed as a
party to the Agreement. Concurrently with the execution of the
Service Agreement, Wisconsin Electric's parent company sold all of
the membership interests in ESE to Cloverland, and ESE was merged
into Cloverland.
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    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 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 comment date.
Anyone filing a motion to intervene or protest must serve a copy of
that document on the Petitioner.
    In addition to publishing the full text of this document in the
Federal Register, the Commission provides all interested persons an
opportunity to view and/or print the contents of this document via the
internet through the Commission's Home Page (http://ferc.gov) using the
eLibrary link. Enter the docket number excluding the last three digits
in the docket number field to access the document. At this time, the
Commission has suspended access to the Commission's Public Reference
Room, due to the proclamation declaring a National Emergency concerning
the Novel Coronavirus Disease (COVID-19), issued by the President on
March 13, 2020. For assistance, contact the Federal Energy Regulatory
Commission at<EMAIL_ADDRESS>or call toll-free, (886) 208-
3676 or TYY,<PHONE_NUMBER>.
    The Commission strongly encourages electronic filings of comments,
protests and interventions in lieu of paper using the eFiling link at
http://www.ferc.gov. Persons unable to file electronically may mail
similar pleadings to the Federal Energy Regulatory Commission, 888
First Street NE, Washington, DC 20426. Hand delivered submissions in
docketed proceedings should be delivered to Health and Human Services,
12225 Wilkins Avenue, Rockville, Maryland 20852.
    Comment Date: 5:00 p.m. Eastern time on November 27, 2020.

    Dated: November 13, 2020.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2020-25559 Filed 11-18-20; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 78, Number 170 (Tuesday, September 3, 2013)]
[Notices]
[Pages 54246-54247]
[FR Doc No: 2013-21331]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings 1

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

    Docket Numbers: ER13-2232-000
    Applicants: Mustang Hills, LLC
    Description: Category Seller Revision to be effective 8/24/2013.
    Filed Date: 8/23/13

    Accession Number: 20130823-5119
    Comments Due: 5 p.m. ET 9/13/13

    Docket Numbers: ER13-2233-000
    Applicants: Midcontinent Independent System Operator, Inc.
    Description: 08-23-2013 Order 764 Compliance Filing to be effective
5/6/2013.
    Filed Date: 8/23/13
    Accession Number: 20130823-5149
    Comments Due: 5 p.m. ET 9/13/13

    Docket Numbers: ER13-2234-000
    Applicants: Interstate Power and Light Company
    Description: Amended Exhibits and Attachments to O&T to be
effective 10/22/2013.
    Filed Date: 8/23/13
    Accession Number: 20130823-5161
    Comments Due: 5 p.m. ET 9/13/13

    Docket Numbers: ER13-2235-000
    Applicants: Southern California Edison Company
    Description: True-Up SGIA & Distrib Serv Agmt with SCE's Power
Production Dept to be effective 10/26/2013.
    Filed Date: 8/23/13
    Accession Number: 20130826-5000
    Comments Due: 5 p.m. ET 9/13/13

    Docket Numbers: ER13-2236-000
    Applicants: Midcontinent Independent System Operator, Inc.
    Description: Request for Waiver of Midcontinent Independent System
Operator, Inc.
    Filed Date: 8/23/13
    Accession Number: 20130823-5170
    Comments Due: 5 p.m. ET 9/13/13

    Docket Numbers: ER13-2237-000
    Applicants: Southern California Edison Company
    Description: Southern California Edison Company submits Relay
Upgrade Agreement at Palo Verde Switchyard with SRP to be effective 8/
27/2013.
    Filed Date: 8/26/13
    Accession Number: 20130826-5161
    Comments Due: 5 p.m. ET 9/16/13

    Take notice that the Commission received the following public
utility holding company filings:

    Docket Numbers: PH13-23-000
    Applicants: ArcLight Capital Holdings, LLC
    Description: FERC-65A Exemption Request of ArcLight Capital
Holdings, LLC.
    Filed Date: 8/23/13
    Accession Number: 20130823-5168
    Comments Due: 5 p.m. ET 9/13/13

    Docket Numbers: PH13-24-000
    Applicants: JP Energy GP LLC and CB Capital Holdings
    Description: FERC-65A Exemption Request of JPE Companies.
    Filed Date: 08/26/2013
    Accession Number: 20130826-5046
    Comment Date: 5 p.m. ET 9/16/13

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: August 26, 2013.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2013-21331 Filed 8-30-13; 8:45 am]
BILLING CODE 6717-01-P


  SEQ CHAPTER \h \r 1 FILE NAME:   company.wpt   (1/1/2005) (xml)

Template Number P25

ATTENTION:

	All commodity terms must comply with the Food and Feed Commodity
Vocabulary database (http://www.epa.gov/pesticides/foodfeed/).

	All text in blue font (instructions for preparing the document), should
be removed prior to sending the document to the Federal Register Staff.
Instructional text and prompts in green font should also be removed.

COMPANY FEDERAL REGISTER DOCUMENT SUBMISSION TEMPLATE

(1/1/2005)

EPA Registration Division contact:  Tony Kish, Product Manager 22
(703)-308-9443

INSTRUCTIONS:  Please utilize this outline in preparing tolerance
petition documents.  In cases where the outline element does not apply
please insert “NA-Remove” and maintain the outline.  The comment
notes that appear on the left margin represent hidden typesetting codes
designed to expedite the processing of the Federal Register document.
Please do not remove or alter these comment notes or change the margins,
font, or format  in your document. Simply replace the instructions that
appear in italics and brackets, i.e., “[insert company name],” with
the information specific to your action.

TEMPLATE:

 by establishing a tolerance for residues of the fungicide
pyraclostrobin, carbamic acid,
[2-[[[1-(4-chlorophenyl)-1H-pyrazol-3-yl]oxy]methyl]phenyl]methoxy-,
methyl ester and its metabolite methyl-N-[[[1-(4-chlorophenyl)
pyrazol-3-yl]oxy]o-tolyl] carbamate (BF 500-3); expressed as parent
compound, in or on the raw agricultural commodities herbs, fresh, 30
parts per million (ppm), avocado, 0.7 ppm, mango, 0.7 ppm, papaya, 0.7
ppm, black sapote, 0.7 ppm, mamey sapote, 0.7 ppm, canistel, 0.7 ppm,
sapodilla, 0.7 ppm, and star apple, 0.7 ppm. EPA has determined that the
petition contains data or information regarding the elements set forth
in section 408(d)(2) of the FFDCA; however, EPA has not fully evaluated
the sufficiency of the submitted data at this time or whether the data
supports granting of the petition.  Additional data may be needed before
EPA rules on the petition.

.  The reproductive and developmental toxicity of pyraclostrobin was
investigated in a 2-generation rat reproduction study as well as in rat
and rabbit teratology studies.  There were no adverse effects on
reproduction, systemic toxicity to adults or developmental toxicity in
the two-generation study so the NOAEL is the highest dose tested of 300
ppm (approximately 32.6 mg/kg bw/day).

No teratogenic effects were noted in either the rat or rabbit
developmental studies.  In the rat study, maternal toxicity observed at
the mid and high dose consisted of decreased food consumption and body
weight gain.  Developmental changes noted at the high dose were
increased incidences of dilated renal pelvis and cervical ribs with no
cartilage.  The maternal NOAEL was 10 mg/kg bw and the developmental
NOAEL was 25 mg/kg bw.

The subchronic toxicity of pyraclostrobin was investigated in 90-day
feeding studies with rats, mice and dogs, and in a 28-day dermal
administration study in rats.  A 90-day neurotoxicity study in rats was
also performed.  Generally, mild toxicity was observed.  At high dose
levels in feeding studies, general findings in all three species were
decreased food consumption and body weight gain and a thickening of the
duodenum.  Anemia occurred at high dose levels in both rats and mice
with accompanying extramedullary hematopoiesis of the spleen in rats.
In rats only, a finding of liver cell hypertrophy was indicative of a
physiological response to the handling of the chemical.   The lowest
NOAEL in the 90-day feeding studies was from the dog study and
determined to be 5.8 mg/kg bw/day.

In the 28-day repeat dose dermal study, no systemic effects were noted
up to the highest dose tested of 250 mg/kg bw/day.

. Pyraclostrobin was administered to groups of 5 male and 5 female
purebred Beagle dogs in the diet at concentrations of 0, 100, 200 and
400 ppm over a period of 12 months.   Signs of toxicity were observed at
the high dose.  Diarrhea was observed throughout the study period for
both sexes. High dose males and females initially lost weight and body
weight gain was decreased for the entire study period for females.
Hematological changes observed were an increase in white blood cells in
males, and an increase in platelets in both sexes at the high dose.
Clinical chemistry demonstrated a decrease in serum total protein,
albumin, globulins and cholesterol in high dose animals of both sexes
possibly due to the diarrhea and reduced nutritional status of the
animals.  The NOAEL was 200 ppm (ca. 5.5 mg/kg bw/day males; 5.4 mg/kg
bw/day females).

In an oncogenicity study, pyraclostrobin was administered to groups of
50 male and 50 female Wistar rats at dietary concentrations of 0; 25;
75, and 200 ppm for 24 months.  In a companion chronic toxicity study,
20 rats/sex were used at the same dose levels as in the oncogenicity
study.  A body weight gain depression of 10-11% in males and 14-22% in
females with an accompanying decrease in food efficiency was observed at
the high dose.   There was no evidence that pyraclostrobin produced a
carcinogenic effect in rats.  The NOAEL for the chronic rat and the
cancer rat study is 75 ppm (ca. 3.4 mg/kg bw/day males; 4.7 mg/kg bw/day
females).

Pyraclostrobin was administered to groups of 50 male and 50 female
B6C3F1 mice at dietary concentrations of 0, 10, 30, 120 and 180 ppm
(females only) for 18 months.  Body weights were reduced at the highest
doses tested in both males and females.  At the high dose, body weight
gain decreases of 27% in females and 29% in males with an accompanying
decrease in food efficiency were observed.  No other signs of toxicity
were noted at any dose level.  The NOAEL  was found to be 30 ppm (ca.
4.1 mg/kg bw/day) for males. The Agency determined that the body weight
effect at the high dose in females was not sufficient to determine an
MTD.  Therefore the NOAEL for females is considered greater than the
highest dose tested of 32.8 mg/kg bw/day.   There was no evidence that
pyraclostrobin produced a carcinogenic effect in mice.

. Exposure assessments were conducted to evaluate the potential risk due
to acute and chronic dietary exposure of the U.S. population to residues
of pyraclostrobin.  This fungicide and its desmethoxy metabolite, in or
on raw agricultural commodities, and metabolites in or on animal fat,
liver, meat and meat byproducts were expressed as the parent compound.
The tolerance values previously established for various cereals,
vegetables, fruits, and animal products are listed in the U.S. EPA final
rule published in the Federal Register October 29, 2004 (Vol 69, No.
209, p 63083 – 63100) and U.S. 40 CFR § 180.582.  This analysis
included all current and proposed tolerance values, including fresh
herbs (30 ppm), mango (0.7 ppm), papaya (0.7 ppm), black sapote (0.7
ppm), mamey sapote (0.7 ppm), canistel (0.7 ppm), sapodilla (0.7 ppm),
and star apple (0.7 ppm).

The pyraclostrobin chronic reference dose (cRfD) is 0.034 mg/kg bw/day
based on the NOAEL of 3.4 mg/kg bw/day in the rat chronic toxicity study
and a 100X safety factor.  The acute reference dose (aRfD) is 3 mg/kg
b.w./day for the general population based on a NOAEL from the acute
neurotoxicity study of 300 mg/kg bw/day and a 100X safety factor.  For
females of child bearing years (13-49 years), the aRfD is 0.05 mg/kg
b.w./day based on the NOAEL of 5 mg/kg bw/day from the rabbit teratology
study and a 100X safety factor.  The EPA determined that the FQPA safety
factor should be 1X for all exposure scenarios.  Therefore, the acute
Population Adjusted Dose (aPAD) and the chronic Population Adjusted Dose
(cPAD) are the same as the aRfD and cRfD, respectively.

Acute Dietary Exposure Assessment

The acute dietary exposure estimates were based on tolerance values,
default process factors, 100% crop treated values for all commodities
except for leafy vegetables, pome fruit, stone fruit, and citrus crop
groups where the tolerance and percent crop treated (%CT) values listed
in the U.S. EPA document DP Barcode No. D323632 (November 30, 2005) were
utilized.  The consumption data was from the USDA Continuing Survey of
Food Intake by Individuals (CSFII 1994 - 1996, 1998) and the EPA Food
Commodity Ingredient Database (FCID) using Exponent's Dietary Exposure
Evaluation Module (DEEM-FCID) software.

The acute population adjusted dose (aPAD) used for females 13-49 years
of age was 0.05 mg/kg bw/day and 3.0 mg/kg bw/day for all other
sub-populations.  Considering the exposure assumptions discussed above,
pyraclostobin acute dietary exposure from food is less than 2.5 % aPAD
for the U.S. population and all sub-populations except females 13-49
years of age that occupies 53.3 % of the aPAD.  The results of the acute
dietary assessment are presented in Table 1.

Table 1.	Results for Pyraclostrobin Acute Dietary Exposure Analysis
Considering all Current and Proposed Tolerances using DEEM-FCID at the
95th Percentile

Population	Exposure Estimate	%aPAD

Subgroups	(mg/kg b.w./day)*

U.S. Population	0.031449	1.05

All Infants (< 1 year old)	0.044759	1.49

Children (1-2 years old)	0.07164	2.39

Children (3-5 years old)	0.055231	1.84

Children (6-12 years old)	0.034292	1.14

Youth (13-19 years old)	0.02442	0.81

Females (13-49 years old)	0.026636	53.3

Adults (20-49 years old)	0.026011	0.87

Adults (50+ years old)	0.026845	0.89

aPAD = acute population adjusted dose

* Exposure Estimate (95th percentile) was based on tolerance values,
default processing factors, and considering 100% crop treated for all
commodities except for leafy vegetables, pome fruit, stone fruit, and
citrus fruit groups which included the tolerance and percent crop
treated values listed in U.S. EPA document DP Barcode No. D323632
(November 30, 2005)

The results of the analysis show that for all sub-populations, the
exposures are below the Agency's level of concern (< 100% aPAD).
Additional refinements in the dietary risk assessment (i.e. utilizing
anticipated residue values, process factors, percent crop treated values
for all crops) would further reduce the estimated exposure values.

Chronic Dietary Exposure Assessment

The chronic dietary exposure estimates were based on tolerance values
for all commodities with the exception that anticipated residues were
utilized for leafy vegetables, apples, and pears; default process
factors; % crop treated values listed in the U.S. EPA document DP
Barcode No. D323632 (November 30, 2005); and 100% crop treated values
for herbs, fresh, mango, papaya, ), black sapote, mamey sapote,
canistel, sapodilla, and star apple.  The consumption data was from the
USDA Continuing Survey of Food Intake by Individuals (CSFII 1994 - 1996,
1998) and the EPA Food Commodity Ingredient Database (FCID) using
Exponent's Dietary Exposure Evaluation Module (DEEM-FCID) software.  The
proposed tolerance values for fresh herbs (30 ppm), mango (0.7 ppm),
papaya (0.7 ppm), black sapote (0.7 ppm), mamey sapote (0.7 ppm),
canistel (0.7 ppm), sapodilla (0.7 ppm), and star apple (0.7 ppm), were
included.

The chronic population adjusted dose (cPAD) used for U.S. population and
all sub-populations is 0.034 mg/kg bw/day. Considering the exposure
assumptions discussed above, pyraclostobin chronic dietary exposure from
food for the U.S. population was 8.2 % of the cPAD.  The most highly
exposure population sub group was children 1-2 years of age at 25.1 %
cPAD.  The results of the chronic dietary assessment are presented in
Table 2.

Table 2. 	Results for Pyraclostrobin Chronic Dietary Exposure Analysis
Considering all Current and Proposed Tolerances using DEEM-FCID

Population	Exposure Estimate	%cPAD

Subgroups	(mg/kg b.w./day)

U.S. Population	0.002779	8.2

All Infants (< 1 year old)	0.00408	12.0

Children (1-2 years old)	0.008525	25.1

Children (3-5 years old)	0.006374	18.7

Children (6-12 years old)	0.003804	11.2

Youth (13-19 years old)	0.002192	6.4

Females (13-49 years old)	0.002083	6.1

Adults (20-49 years old)	0.002135	6.3

Adults (50+ years old)	0.002281	6.7

cPAD = chronic  population adjusted dose

* Exposure estimates based on tolerance values for all commodities with
the exception of anticipated residues for leafy vegetables, apples, and
pears; default processing factor; and considering % crop treated values
listed in the U.S. EPA document DP Barcode No. D323632 (November 30,
2005); and 100% crop treated values for herbs, fresh, mango, papaya,
black sapote, mamey sapote, canistel, sapodilla, and star apple

The results of the analysis show that for all sub-populations, the
exposures are below a level of concern (< 100% cPAD).  Additional
refinements in the chronic dietary risk assessment (i.e. utilizing
anticipated residue values for all crops) would further reduce the
estimated exposure values.

. Based on the PRZM/EXAMS and SCIGROW models, the peak EDWCs of
pyraclostrobin for acute exposure are estimated to be 22.6 ug/L (ppb) in
surface water and 0.02 ug/L in shallow ground water.  The peak EDWCs for
chronic exposure are estimated to be 1.9 ug/L in surface water and 0.02
ug/L in shallow ground water.  These concentrations are based on maximum
applications to turf, which have the highest labeled application rate of
any pyraclostrobin use.

Drinking water contributions were assessed based on the maximum
estimated pyraclostrobin water concentrations (acute - 22.6 ug/L,
chronic 1.9 ug/L), and water consumption and body weights reported in
CSFII, using DEEM-FCID software.  The acute and chronic estimated water
exposure values are summarized in Tables 3 and 4, respectively.  Minimal
exposure of pyraclostrobin occurs through drinking water with < 0.5% the
aPAD and cPAD for all subpopulations with the exception of females 13-49
years of age with a 2.2% aPAD.

Table 3. 	Results for Pyraclostrobin Acute Water Exposure Analysis
Considering the Maximum Estimated Acute Drinking Water Concentration
using

DEEM-FCID

Population	Water Exposure Estimate	%aPAD

Subgroups	(mg/kg b.w./day)

U.S. Population	0.001181	0.04

All Infants (< 1 year old)	0.004451	0.15

Children (1-2 years old)	0.001852	0.06

Children (3-5 years old)	0.001692	0.06

Children (6-12 years old)	0.001178	0.04

Youth (13-19 years old)	0.000958	0.03

Females (13-49 years old)	0.001100	2.20

Adults (20-49 years old)	0.001094	0.04

Adults (50+ years old)	0.000988	0.03

aPAD = acute  population adjusted dose

Based on estimated acute surface water value of 22.6 ug/L

Table 4. 	Results for Pyraclostrobin Chronic Water Exposure Analysis
Considering the Maximum Estimated Chronic Drinking Water Concentration
using DEEM-FCID

Population	Water Exposure Estimate	%cPAD

Subgroups	(mg/kg b.w./day)

U.S. Population	0.00004	0.1

All Infants (< 1 year old)	0.000131	0.4

Children (1-2 years old)	0.000059	0.2

Children (3-5 years old)	0.000056	0.2

Children (6-12 years old)	0.000038	0.1

Youth (13-19 years old)	0.000029	0.1

Females (13-49 years old)	0.000037	0.1

Adults (20-49 years old)	0.000037	0.1

Adults (50+ years old)	0.000039	0.1

cPAD = chronic  population adjusted dose

Based on estimated chronic surface water value of 1.9 ug/L

Acute Aggregate Exposure and Risk (Food and water)

The aggregate acute risk includes residues of pyraclostrobin from food
and water (Table 5). Exposures from residential uses are not included in
the acute aggregate assessment.  The results demonstrate that there are
no safety concerns for any subpopulation based on established and new
uses, and that the results clearly meet the FQPA standard of reasonable
certainty of no harm.

Table 5. 	Estimated Acute Aggregate Exposure and Risk of Pyraclostrobin

Population Subgroup	aPAD (mg/kg/day)	Food Exposure (mg/kg/day)	Water
Exposure (mg/kg/day)	Total Exposure (mg/kg/day)	% aPAD

U.S. Population	3	0.031449	0.001181	0.03263	1.09

All Infants (< 1 yr old)	3	0.044759	0.004451	0.04921	1.64

Children 1-2 years	3	0.07164	0.001852	0.073492	2.45

Children 3-5 years	3	0.055231	0.001692	0.056923	1.90

Children 6 – 12 years	3	0.034292	0.001178	0.03547	1.18

Youth 13-19 years	3	0.02442	0.000958	0.025378	0.85

Females 13-49 years	0.05	0.026636	0.0011	0.027736	55.47

Adults 20-49 years	3	0.026011	0.001094	0.027105	0.90

Adults + 50	3	0.026845	0.000988	0.027833	0.93

Short- and Intermediate Term Aggregate Exposure and Risk (food,water,
and residential)

Short-term aggregate risk from pyraclostrobin takes into account
exposures from dietary consumption (food and water) and residential
exposure from turf use.  Post application exposure from the turf use is
considered short-term.  The aggregate MOE from food, water, and
residential exposure are 129 and 266 for the children 1-2 years old and
the US population, respectively.  These MOE are greater than the target
MOE of 100 which indicates there is no safety concern.  The results of
the analysis are shown in Table 6.

Table 6. 	Estimated Short/Intermediate Term Aggregate Exposure and Risk
of Pyraclostrobin

Population	NOAEL (mg/kg/day)	Target MOE1	Food Exposure (mg/kg/day)	Water
Exposure (mg/kg/day)	Residential Exposure2 (mg/kg/day)	Total Exposure
(mg/kg/day)	MOE3

US	5.8	100	0.002779	0.00004	0.019	0.021819	266

Child 1-2 yr old	5.8	100	0.008525	0.000059	0.036425	0.045009	129

1 Target MOE is 100.

2  Residential Exposure = Exposure to adult while playing golf.

3 Aggregate MOE = (NOAEL / (Food + Water + Residential Exposure)

Chronic Aggregate Exposure and Risk (food and water)

The aggregate chronic risk includes residues of pyraclostrobin from food
and water (Table 7). Exposures from residential uses are not included in
the chronic aggregate assessment.  The results demonstrate there are no
safety concerns for any subpopulation based on established and new uses,
and that the results clearly meet the FQPA standard of reasonable
certainty of no harm.

  Table 7. 	Estimated Chronic Aggregate Exposure and Risk of
Pyraclostrobin

Population Subgroup	cPAD (mg/kg/day)	Food Exposure (mg/kg/day)	Water
Exposure (mg/kg/day)	Total Exposure (mg/kg/day)	% cPAD

U.S. Population	0.034	0.002779	0.00004	0.002819	8.29

All Infants (< 1 yr old)	0.034	0.00408	0.000131	0.004211	12.39

Children 1-2 years	0.034	0.008525	0.000059	0.008584	25.25

Children 3-5 years	0.034	0.006374	0.000056	0.00643	18.91

Children 6 – 12 years	0.034	0.003804	0.000038	0.003842	11.30

Youth 13-19 years	0.034	0.002192	0.000029	0.002221	6.53

Females 13-49 years	0.034	0.002083	0.000037	0.00212	6.24

Adults 20-49 years	0.034	0.002135	0.000037	0.002172	6.39

Adults + 50	0.034	0.002281	0.000039	0.00232	6.82

Aggregate Cancer Risk for U.S. Population

The aggregate MOE value (considering food and drinking water) was
calculated for pyraclostrobin and is shown in Table 8.  The 36-year
average of pyraclostrobin in surface water that was estimated by
PRZM/EXAMS for use in the chronic/cancer risk assessment is 1.2 ug/L.
The results demonstrate there are no safety concerns for US population
based on established and new uses, and that the results clearly meet the
FQPA standard of reasonable certainty of no harm.

Table 8. 	Aggregate Cancer Risk of Pyraclostrobin to the U.S. Population

Population	NOAEL (mg/kg/day)	Food Exposure (mg/kg/day)	Water Exposure
(mg/kg/day)	Total Exposure (mg/kg/day)	Total MOE

U.S. Population	32.80	0.002779	0.000025	0.002804	11698

	Section 408(b)(2)(D)(v) requires that, when considering whether to
establish, modify, or revoke a tolerance, the Agency consider
``available information'' concerning the cumulative effects of a
particular pesticide's residues and ``other substances that have a
common mechanism of toxicity.'  Pyraclostrobin is a foliar fungicide
which belongs to the new class of strobilurin chemistry.  It is a
synthetic analog of strobilurin A, a naturally occurring antifungal
metabolite of the mushroom Strobillurus tenacellus (Anke et. al., 1977).
The active ingredient acts in the fungal cell through inhibition of
electron transport in the mitochondrial respiratory chain at the
position of the cytochrome-bc1 complex.  The protective effect is due to
the resultant death of the fungal cells by disorganization of the fungal
membrane system.  Pyraclostrobin also acts curatively to prevent the
increase and spread of fungal infections by inhibiting mycelial growth
and sporulation on the leaf surface. BAS 500F inhibits spore
germination, germ tube growth and penetration into the host tissues

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[Federal Register Volume 77, Number 196 (Wednesday, October 10, 2012)]
[Rules and Regulations]
[Pages 61515-61518]
[FR Doc No: 2012-24776]

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

 ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2011-0949; FRL-9361-7]

Alkyl Amines Polyalkoxylates; Exemption From the Requirement of a
Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation amends the exemption from the requirement of a
tolerance for residues alkyl amines polyalkoxylates under 40 CFR
180.920 and 40 CFR 180.930 to include the additional Chemical Abstract
Service Registry Number (CAS Reg. No.) 1266162-49-5. BASF Corporation
submitted a petition to EPA under the Federal Food, Drug, and Cosmetic
Act (FFDCA), requesting an amendment to an existing requirement of a
tolerance.

DATES: This regulation is effective October 10, 2012. Objections and
requests for hearings must be received on or before December 10, 2012,
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-2011-0949 is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), EPA West Bldg., Rm. 3334, 1301 Constitution
Ave. NW., Washington, DC 20460-0001. The Public Reading Room is open
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays. The telephone number for the Public Reading Room is (202)
566-1744, and the telephone number for the OPP Docket is (703) 305-
5805. Please review the visitor instructions and additional information
about the docket available at http://www.epa.gov/dockets.

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

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of 40 CFR
part 180 through the Government Printing Office's e-CFR site at http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

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

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2011-0949 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
December 10, 2012. 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 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-2011-0949, 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 Confidential Business
Information (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.htm.

Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Petition for Exemption

    In the Federal Register of March 14, 2012 (77 FR 15012) (FRL-9335-
9), EPA issued a notice pursuant to FFDCA section 408, 21 U.S.C. 346a,
announcing the filing of a pesticide petition (PP 1E7931) by BASF
Corporation, 100 Campus Drive; Florham Park, NJ 07932. The petition
requested that 40 CFR 180.920 and 180.930 be amended by modifying an
exemption from the requirement of a tolerance for residues of N,N-Bis-
[alpha]-ethyl-[omega]-hydroxypoly(oxy-1,2-ethanediyl) C8-C18 saturated
and unsaturated alkylamines; the poly(oxy-1,2-ethanediyl) content is 2-
60 moles (CAS Reg. Nos. 10213-78-2, 25307-17-9, 26635-92-7, 26635-93-8,
288259-52-9, 58253-49-9, 61790-82-7, 61791-14-8, 61791-24-0, 61791-26-
2, 61791-31-9, 61791-44-4, 68155-33-9, 68155-39-5, 68155-40-8,70955-14-
5, 73246-96-5); herein referred to as alkyl amines polyalkoxylates.
Specifically, the petition requested that the exemption also include
the alkyl amines polyalkoxylate described by CAS Reg. No. 1266162-49-5.
That notice referenced a summary of the petition prepared by BASF
Corporation, the petitioner, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the
notice of filing.
    In this petition, BASF Corporation claims that the chemical
represented by CAS Reg. No. 1266162-49-5 (poly(oxy-1,2-ethandiyl),
[alpha],[alpha]'-[[(2-propylheptyl)imino]di-2,1-ethanediyl]bis[[omega]-
hydroxy-) is covered by the published tolerance exemption for alkyl
amines polyalkoxylates and that no further data or review is required
to amend the existing tolerance exemption to include the additional CAS
Reg. No.

III. Inert Ingredient Definition

    Inert ingredients are all ingredients that are not active
ingredients as defined in 40 CFR 153.125 and include, but are not
limited to, the following types of ingredients (except when they have a
pesticidal efficacy of their own): Solvents such as alcohols and
hydrocarbons; surfactants such as polyoxyethylene polymers and fatty
acids; carriers such as clay and diatomaceous earth; thickeners such as
carrageenan and modified cellulose; wetting, spreading, and dispersing
agents; propellants in aerosol dispensers; microencapsulating agents;
and emulsifiers. The term ``inert'' is not intended to imply
nontoxicity; the ingredient may or may not be chemically active.
Generally, EPA has exempted inert ingredients from the requirement of a
tolerance based on the low toxicity of the individual inert
ingredients.

IV. Aggregate Risk Assessment and Determination of Safety

    Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an
exemption from the requirement for 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 * * *.''
    EPA establishes exemptions from the requirement of a tolerance only
in those cases where it can be clearly demonstrated that the risks from
aggregate exposure to pesticide chemical residues under reasonably
foreseeable circumstances will pose no appreciable risks to human
health. In order to determine the risks from aggregate exposure to
pesticide inert ingredients, the Agency considers the toxicity of the
inert ingredient in conjunction with possible exposure to residues of
the inert ingredient through food, drinking water, and through other
exposures that occur as a result of pesticide use in residential
settings. If EPA is able to determine that a finite tolerance is not
necessary to ensure that there is a reasonable certainty that no harm
will result from aggregate exposure to the inert ingredient, an
exemption from the requirement of a tolerance may be established.
    Consistent with FFDCA section 408(c)(2)(A), and the factors
specified in FFDCA section 408(c)(2)(B), 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 alkyl amine polyalkoxylates
including exposure resulting from the exemption established by this
action. EPA's assessment of exposures and risks associated with alkyl
amine polyalkoxylates follows.
    The Agency agrees with the petitioner that CAS Reg. No. 1266162-49-
5 is an alkyl amine polyalkoxylate similar to the other alkyl amine
polyalkoxylates present in the exemption for N,N-Bis-[alpha]-ethyl-
[omega]-hydroxypoly(oxy-1,2-ethanediyl) C8-C18 saturated and
unsaturated alkylamines; the poly(oxy-1,2-ethanediyl) content is 2-60
moles (CAS Reg. Nos. 10213-78-2, 25307-17-9, 26635-92-7, 26635-93-8,
288259-52-9, 58253-49-9, 61790-82-7, 61791-14-8, 61791-24-0, 61791-26-
2, 61791-31-9, 61791-44-4, 68155-33-9, 68155-39-5, 68155-40-8, 70955-
14-5, 73246-96-5). In 2009, in establishing the exemption for the alkyl
amine polyalkoxylates, EPA assessed the safety of the alkyl amine
polyalkoxylates generally using worst case exposure assumptions. (74 FR
28616) (FRL-8418-6). EPA concluded that that assessment showed that
exempting the alkyl amine polyalkoxylates from the requirement from a
tolerance would be safe. Inclusion of chemical described by the CAS
Reg. No. 1266162-49-5 in the risk assessment for the alkyl amine
polyalkoxylates would in no way alter that prior risk assessment given
the generic findings on toxicity and the worst case exposure
assumptions used in that risk assessment. Accordingly, based on the
findings in that earlier rule, EPA has determined that there is a
reasonable certainty that no harm to any population subgroup, including
infants and children, will result from aggregate exposure to alkyl
amine polyalkoxylates, including the chemical described by the CAS Reg.
No.

1266162-49-5, under reasonably foreseeable circumstances. Therefore,
the amendment of an exemption from tolerance under 40 CFR 180.920 and
180.930 for residues of alkyl amine polyalkoxylates to include the
chemical described by the CAS Reg. No. 1266162-49-5 is safe under FFDCA
section 408.

V. Other Considerations

A. Analytical Enforcement Methodology

    An analytical method is not required for enforcement purposes since
the Agency is establishing an exemption from the requirement of a
tolerance without any numerical limitation.

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 alkyl amine polyalkoxylates.

VI. Conclusions

    Therefore, the exemption from the requirement of a tolerance under
40 CFR 180.920 and 180.930 for alkyl amine polyalkoxylates is amended
to include CAS Reg. No. 1266162-49-5.

VII. Statutory and Executive Order Reviews

    This final rule establishes a tolerance under FFDCA section 408(d)
in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this final rule has
been exempted from review under Executive Order 12866, this final rule
is not subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997). This final rule does not contain
any information collections subject to OMB approval under the Paperwork
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any
special considerations under Executive Order 12898, entitled ``Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
    This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this final rule. In addition,
this final rule does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA) (15 U.S.C. 272 note).

VIII. 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 28, 2012.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.
    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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

0
2. In Sec.  180.920, the table is amended by revising the following
inert ingredient to read as follows:

Sec.  180.920  Inert ingredients use pre-harvest; exemptions from the
requirement of a tolerance.

* * * * *

----------------------------------------------------------------------------------------------------------------
          Inert ingredients                     Limits                                 Uses
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
N,N-Bis-[alpha]-ethyl-[omega]-        Not to exceed 25% in        Surfactants, related adjuvants of surfactants.
 hydroxypoly(oxy-1,2-ethanediyl) C8-   herbicide formulations
 C18 saturated and unsaturated         and 10% in insecticide
 alkylamines; the poly(oxy-1,2-        and fungicide
 ethanediyl) content is 2-60 moles     formulations.
 (CAS Reg. Nos. 10213-78-2, 25307-17-
 9, 26635-92-7, 26635-93-8, 288259-
 52-9, 58253-49-9, 61790-82-7, 61791-
 14-8, 61791-24-0, 61791-26-2, 61791-
 31-9, 61791-44-4, 68155-33-9, 68155-
 39-5, 68155-40-8,70955-14-5, 73246-
 96-5, 1266162-49-5).

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

0
3. In Sec.  180.930, the table is amended by revising the following
inert ingredient to read as follows:

Sec.  180.930  Inert ingredients applied to animals; exemptions from
the requirement of a tolerance.

* * * * *

----------------------------------------------------------------------------------------------------------------
          Inert ingredients                     Limits                                 Uses
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
N,N-Bis-[alpha]-ethyl-[omega]-        Not to exceed 25% in        Surfactants, related adjuvants of surfactants
 hydroxypoly(oxy-1,2-ethanediyl) C8-   herbicide formulations
 C18 saturated and unsaturated         and 10% in insecticide
 alkylamines; the poly(oxy-1,2-        and fungicide
 ethanediyl) content is 2-60 moles     formulations.
 (CAS Reg. Nos. 10213-78-2, 25307-17-
 9, 26635-92-7, 26635-93-8, 288259-
 52-9, 58253-49-9, 61790-82-7, 61791-
 14-8, 61791-24-0, 61791-26-2, 61791-
 31-9, 61791-44-4, 68155-33-9, 68155-
 39-5, 68155-40-8,70955-14-5, 73246-
 96-5, 1266162-49-5).

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

[FR Doc. 2012-24776 Filed 10-9-12; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 84, Number 38 (Tuesday, February 26, 2019)]
[Notices]
[Pages 6148-6150]
[FR Doc No: 2019-03246]

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

Food and Drug Administration

[Docket No. FDA-2018-D-4367]

Bioavailability Studies Submitted in New Drug Applications or
Investigational New Drug Applications--General Considerations; Draft
Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled
``Bioavailability Studies Submitted in NDAs or INDs--General
Considerations.'' This draft guidance provides recommendations to
sponsors planning to include bioavailability (BA) information for drug
products in investigational new drug applications (INDs), new drug
applications (NDAs), and NDA supplements. This draft guidance revises
and replaces FDA's March 2014 draft guidance for industry entitled
``Bioavailability and Bioequivalence Studies Submitted in NDAs or
INDs--General Considerations,'' which addresses BA or bioequivalence
(BE) studies for INDs, NDAs, and NDA supplements.

DATES: Submit either electronic or written comments on the draft
guidance by May 28, 2019 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

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

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2018-D-4367 for ``Bioavailability Studies Submitted in NDAs or
INDs--General Considerations.'' Received comments will be placed in the
docket and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one
self-addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Dakshina Chilukuri, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Bioavailability Studies Submitted in NDAs or INDs--General
Considerations.'' Determining the BA of formulations is critical during
the life cycle of drug products and aids in FDA's evaluation of the
safety and effectiveness of a product in an IND, NDA, or NDA
supplements. This draft guidance provides recommendations to sponsors
planning to include BA information for drug products in INDs, NDAs, and
NDA supplements. This draft guidance contains recommendations on how to
meet the BA requirements set forth in 21 CFR part 320 as they apply to
dosage forms intended for oral administration. The draft guidance is
also applicable to non-orally administered drug products when it is
appropriate to rely on systemic exposure measures to determine the BA
of a drug (e.g., transdermal delivery systems and certain rectal and
nasal drug products). The draft guidance provides recommendations on
conducting relative BA studies during the IND period for an NDA and BE
studies during the postapproval period for certain changes to drug
products.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on
``Bioavailability Studies in NDAs or INDs--General Considerations.'' It
does not establish any rights for any person and is not binding on FDA
or the public. You can use an alternative approach if it satisfies the
requirements of the applicable statutes and regulations. This guidance
is not subject to Executive Order 12866.

II. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collection of information submitted under 21 CFR part 312 (INDs) has
been approved under OMB control number 0910-0014; and the collection of
information submitted under 21 CFR part 314 (NDAs) has been approved
under OMB control number 0910-0001.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance
at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or
https://www.regulations.gov.

    Dated: February 20, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-03246 Filed 2-25-19; 8:45 am]
 BILLING CODE 4164-01-P