[Federal Register Volume 83, Number 117 (Monday, June 18, 2018)]
[Notices]
[Pages 28328-28329]
[FR Doc No: 2018-13008]

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

DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2018-0007]

Qualification of Drivers; Exemption Applications; Vision

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

ACTION: Notice of final disposition.

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

SUMMARY: FMCSA announces its decision to exempt 13 individuals from the
vision requirement in the Federal Motor Carrier Safety Regulations
(FMCSRs) to operate a commercial motor vehicle (CMV) in interstate
commerce. They are unable to meet the vision requirement in one eye for
various reasons. The exemptions enable these individuals to operate
CMVs in interstate commerce without meeting the vision requirement in
one eye.

DATES: The exemptions were applicable on May 10, 2018. The exemptions
expire on May 10, 2020.

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

SUPPLEMENTARY INFORMATION:

I. Electronic Access

    You may see all the comments online through the Federal Document
Management System (FDMS) at http://www.regulations.gov.
    Docket: For access to the docket to read background documents or
comments, go to http://www.regulations.gov and/or Room W12-140 on the
ground level of the West Building, 1200 New Jersey Avenue SE,
Washington, DC, between 9 a.m. and 5 p.m., e.t., Monday through Friday,
except Federal holidays.
    Privacy Act: In accordance with 5 U.S.C. 553(c), DOT solicits
comments from the public to better inform its rulemaking process. DOT
posts these comments, without edit, including any personal information
the commenter provides, to http://www.regulations.gov, as described in
the system of records notice (DOT/ALL-14 FDMS), which can be reviewed
at http://www.dot.gov/privacy.

II. Background

    On April 9, 2018, FMCSA published a notice announcing receipt of
applications from 13 individuals requesting an exemption from vision
requirement in 49 CFR 391.41(b)(10) and requested comments from the
public (83 FR 15214). The public comment period ended on May 9, 2018,
and no comments were received.
    FMCSA has evaluated the eligibility of these applicants and
determined that granting the exemptions to these individuals would
achieve a level of safety equivalent to or greater than the level that
would be achieved by complying with the current regulation 49 CFR
391.41(b)(10).
    The physical qualification standard for drivers regarding vision
found in 49 CFR 391.41(b)(10) states that a person is physically
qualified to driver a CMV if that person has distant visual acuity of
at least 20/40 (Snellen) in each eye without corrective lenses or
visual acuity separately corrected to 20/40 (Snellen) or better with
corrective lenses, distant binocular acuity of a least 20/40 (Snellen)
in both eyes with or without corrective lenses, field of vision of at
least 70[deg] in the horizontal meridian in each eye, and the ability
to recognize the colors of traffic signals and devices showing red,
green, and amber.

III. Discussion of Comments

    FMCSA received no comments in this proceeding.

IV. Basis for Exemption Determination

    Under 49 U.S.C. 31136(e) and 31315, FMCSA may grant an exemption
from the vision standard in 49 CFR 391.41(b)(10) if the exemption is
likely to achieve an equivalent or greater level of safety than would
be achieved without the exemption. The exemption allows applicants to
operate CMVs in interstate commerce.
    The Agency's decision regarding these exemption applications is
based on medical reports about the applicants' vision as well as their
driving records and experience driving with the vision deficiency. The
qualifications, experience, and medical condition of each applicant
were stated and discussed in detail in the April 9, 2018, Federal
Register notice (83 FR 15214) and will not be repeated in this notice.
    FMCSA recognizes that some drivers do not meet the vision
requirement but have adapted their driving to accommodate their
limitation and demonstrated their ability to drive safely. The 13
exemption applicants listed in this notice are in this category. They
are unable to meet the vision requirement in one eye for various
reasons, including amblyopia, central retinal artery occlusion, central
vein occlusion, complete loss of vision, optic nerve damage,
prosthesis, retinal scar, and scleral laceration. In most cases, their
eye conditions were not recently developed. Eight of the applicants
were either born with their vision impairments or have had them since
childhood. The five individuals that sustained their vision conditions
as adults have had it for a range of 2 to 10 years. Although each
applicant has one eye which does not meet the vision requirement in 49
CFR 391.41(b)(10), each has at least 20/40 corrected vision in the
other eye, and in a doctor's opinion, has sufficient vision to perform
all the tasks necessary to operate a CMV.
    Doctors' opinions are supported by the applicants' possession of a
valid license to operate a CMV. By meeting State licensing
requirements, the applicants demonstrated their ability to operate a
CMV, with their limited vision in intrastate commerce, even though
their vision disqualified them from driving in interstate commerce. We
believe that the applicants' intrastate driving experience and history
provide an adequate basis for predicting their ability to drive safely
in interstate commerce. Intrastate driving, like interstate operations,
involves substantial driving on highways on the interstate system and
on other roads built to interstate standards. Moreover, driving in
congested urban areas exposes the driver to more pedestrian and
vehicular traffic than exists on interstate highways. Faster reaction
to traffic and traffic signals is generally required because distances
between them are more compact. These conditions tax visual capacity and
driver response just as intensely as interstate driving conditions.
    The applicants in this notice have driven CMVs with their limited
vision in careers ranging for 3 to 61 years. In the past three years,
no drivers were involved in crashes, and one driver was convicted of a
moving violation in a CMV. All the applicants achieved a record of
safety while driving with their vision impairment, demonstrating the
likelihood that they have adapted their driving skills to accommodate
their condition. As the applicants' ample driving histories with their
vision

deficiencies are good predictors of future performance, FMCSA concludes
their ability to drive safely can be projected into the future.
    Consequently, FMCSA finds that in each case exempting these
applicants from the vision requirement in 49 CFR 391.41(b)(10) is
likely to achieve a level of safety equal to that existing without the
exemption.

V. Conditions and Requirements

    The terms and conditions of the exemption are provided to the
applicants in the exemption document and includes the following: (1)
Each driver must be physically examined every year (a) by an
ophthalmologist or optometrist who attests that the vision in the
better eye continues to meet the standard in 49 CFR 391.41(b)(10) and
(b) by a certified Medical Examiner who attests that the individual is
otherwise physically qualified under 49 CFR 391.41; (2) each driver
must provide a copy of the ophthalmologist's or optometrist's report to
the Medical Examiner at the time of the annual medical examination; and
(3) each driver must provide a copy of the annual medical certification
to the employer for retention in the driver's qualification file, or
keep a copy in his/her driver's qualification file if he/she is self-
employed. The driver must also have a copy of the exemption when
driving, for presentation to a duly authorized Federal, State, or local
enforcement official.

VI. Preemption

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

VII. Conclusion

    Based upon its evaluation of the 13 exemption applications, FMCSA
exempts the following drivers from the vision requirement, 49 CFR
391.41(b)(10), subject to the requirements cited above:

Ahmed Abukhatwa (MI)
James A. Barlow (OH)
Thomas R. Danser (PA)
Jerome DeFabo, Jr. (PA)
Jorge Gonzales (FL)
Jimmy D. Johnson (MS)
Michael S. Mai (KS)
Jose M. Rios (NY)
Michael B. Sauseda (IL)
Steven D. Schlichting (NE)
Jesse P. Schuster (ND)
Joseph L. Smith (WV)
Larry L. Stewart (NC)

    In accordance with 49 U.S.C. 31136(e) and 31315, each exemption
will be valid for two years from the effective date unless revoked
earlier by FMCSA. The exemption will be revoked if the following
occurs: (1) The person fails to comply with the terms and conditions of
the exemption; (2) the exemption has resulted in a lower level of
safety than was maintained prior to being granted; or (3) continuation
of the exemption would not be consistent with the goals and objectives
of 49 U.S.C. 31136 and 31315.

    Issued on: June 11, 2018.
Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2018-13008 Filed 6-15-18; 8:45 am]
 BILLING CODE 4910-EX-P


											           November 27, 2007

NATIONAL EXPOSURE RESEARCH LABORATORY STANDING SUBCOMMITTEE

DRAFT AGENDA

November 28, 2007

2:00 pm – 4:00 pm Eastern Time

Participation by Teleconference Only

866-299-3188

code:<PHONE_NUMBER>#

2:00 - 2:10 pm	Welcome

	-  Introduction of Subcommittee Members	Dr. Kenneth L. Demerjian,

	- Overview of Subcommittee Objectives	Subcommittee Chair

2:10 - 2:20 pm	Administrative Procedures and	Ms. Susan Peterson

	NERL Subcommittee Background	Subcommittee DFO

2:20 - 3:00 pm	ORD/NERL Overview	Dr. Larry Reiter

Office of Research and Development (ORD)

3:00 - 3:10 pm	Public Comment

3:10 - 3:40 pm	Discussion of Charge	Dr. Kenneth L. Demerjian

		Subcommittee Chair/

		Dr. Larry Reiter

ORD

3:40 - 4:00 pm 	Preparation for Face-to-Face 	Dr. Kenneth L. Demerjian,

	Meeting	Subcommittee Chair

	- Review Draft Agenda

	- Discuss Writing Assignments

	- Identify Additional Information Needs

4:00 pm	Adjourn

            A Federal Advisory Committee for the U.S. Environmental Protection Agency’s Office of Research and Development


[Federal Register Volume 79, Number 99 (Thursday, May 22, 2014)]
[Notices]
[Page 29478]
[FR Doc No: 2014-11857]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Public Notice for Waiver of Aeronautical Land-Use Assurance

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of intent of waiver with respect to land; Freeman
Municipal Airport, Seymour, Indiana.

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

SUMMARY: The FAA is considering a proposal to change 3.1 acres of
airport land from aeronautical use to non-aeronautical use and to
authorize the sale of airport property located at Freeman Municipal
Airport, Seymour, Indiana. The aforementioned land is not needed for
aeronautical use.
    The property is located at 740 East C Avenue, on the corner of 4th
Avenue. The property is surplus airport property, following its
military air base use during World War II, and is no longer needed for
aeronautical purposes. It is currently, and has long been, leased for
use as light industrial business. Upon release, the land will be sold
for continued use for light industrial purposes.

DATES: Comments must be received on or before June 23, 2014.

ADDRESSES: Documents are available for review by appointment at the FAA
Chicago Airports District Office, Michael Ferry, Program Manager, 2300
East Devon Avenue, Des Plaines, IL, 60018, Telephone:<PHONE_NUMBER>
<EMAIL_ADDRESS>or at the Seymour Municipal Airport Authority,
Don Furlow, 1025 A Avenue, Seymour, IN, 47274,<PHONE_NUMBER>.
    Written comments on the Sponsor's request must be delivered or
mailed to: Michael Ferry, Program Manager, Federal Aviation
Administration, Chicago Airports District Office, 2300 East Devon
Avenue, Des Plaines, IL, 60018, Telephone Number:<PHONE_NUMBER>/FAX
Number:<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Michael Ferry, Program Manager,
Federal Aviation Administration, Chicago Airports District Office, 2300
East Devon Avenue, Des Plaines, IL, 60018. Telephone Number: (847) Michael.Ferry<EMAIL_ADDRESS>Number:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: In accordance with section 47107(h) of Title
49, United States Code, this notice is required to be published in the
Federal Register 30 days before modifying the land-use assurance that
requires the property to be used for an aeronautical purpose.
    The property has long been surplus airport property, following its
use as a military air base during World War II, and is currently being
used for light industrial business. The land was acquired as airport
property from the United States government in 1948 through the Surplus
Property Act. The airport plans to sell the property at fair market
value upon release. The income from the sale will be reinvested in the
airport.
    The disposition of proceeds from the sale of the airport property
will be in accordance with FAA's Policy and Procedures Concerning the
Use of Airport Revenue, published in the Federal Register on February
16, 1999 (64 FR 7696).
    This notice announces that the FAA is considering the release of
the subject airport property at the Freeman Municipal Airport, Seymour,
Indiana, from federal land covenants, subject to a reservation for
continuing right of flight as well as restrictions on the released
property as required in FAA Order 5190.6B section 22.16. Approval does
not constitute a commitment by the FAA to financially assist in the
disposal of the subject airport property nor a determination of
eligibility for grant-in-aid funding from the FAA.

Legal Description

    LOT 41A OF ``SEYMOUR MUNICIPAL AIRPORT AUTHORITY--MINOR
SUBDIVISION'' AS RECORDED IN PLAT CABINET 7, PAGE 1948 IN THE OFFICE OF
THE JACKSON COUNTY RECORDER AND DESCRIBED AS FOLLOWS:
    BEGINNING AT A 1'' STEEL PIPE (FOUND) MARKING THE WEST CORNER OF
LOT 41A; THENCE NORTH 44[deg]13'57'' EAST (ASSUMED BEARING) ALONG THE
NORTHWEST LINE OF SAID LOT A DISTANCE OF 351.16 FEET TO THE NORTH
CORNER OF SAID LOT AND A 1'' STEEL PIPE (FOUND); THENCE SOUTH
45[deg]48'15'' EAST ALONG THE NORTHEAST LINE OF SAID LOT A DISTANCE OF
384.04 FEET TO THE EAST CORNER OF SAID LOT AND A 5/8'' REBAR AND CAP
(FOUND); THENCE SOUTH 44[deg]11'45'' WEST ALONG THE SOUTHEAST LINE OF
SAID LOT A DISTANCE OF 351.29 FEET TO THE SOUTH CORNER OF SAID LOT AND
A 5/8'' REBAR AND CAP (FOUND); THENCE NORTH 45[deg]47'01'' WEST ALONG
THE SOUTHWEST LINE OF SAID LOT A DISTANCE OF 384.26 FEET TO THE POINT
OF BEGINNING, CONTAINING 3.10 ACRES, MORE OR LESS, AND SUBJECT TO ALL
LEGAL RIGHTS OF WAY AND EASEMENTS.

    Issued in Des Plaines, Illinois, on May 12, 2014.
Jim Keefer,
Manager, Chicago Airports District Office, FAA, Great Lakes Region.
[FR Doc. 2014-11857 Filed 5-21-14; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: September 26, 2007 (Volume 72, Number 186)]
[Rules and Regulations]
[Page 54584-54588]
[DOCID:fr26se07-18]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2007-0145; FRL-8148-1]

Tepraloxydim; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes a tolerance for residues of
tepraloxydim in or on imported flax, seed; lentil, seed; and pea, dry
seed. BASF requested this tolerance under the Federal Food, Drug, and
Cosmetic Act (FFDCA).

DATES: This regulation is effective September 26, 2007. Objections and
requests for hearings must be received on or before November 26, 2007,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2007-0145. To access the
electronic docket, go to http://www.regulations.gov, select ``Advanced

Search,'' then ``Docket Search.'' Insert the docket ID number where
indicated and select the ``Submit'' button. Follow the instructions on
the regulations.gov website to view the docket index or access
available documents. All documents in the docket are listed in the
docket index available in regulations.gov. Although listed in the
index, some information is not publicly available, e.g., Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available in the electronic docket at http://www.regulations.gov, or,

if only available in hard copy, at the OPP Regulatory Public Docket in
Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr.,
Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m.,
Monday through Friday, excluding legal holidays. The Docket Facility
telephone number is<PHONE_NUMBER>.

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

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to those
engaged in the following activities:
     Crop production (NAICS code 111), e.g., agricultural
workers; greenhouse, nursery, and floriculture workers; farmers.
     Animal production (NAICS code 112), e.g., cattle ranchers
and farmers, dairy cattle farmers, livestock farmers.
     Food manufacturing (NAICS code 311), e.g., agricultural
workers; farmers; greenhouse, nursery, and floriculture workers;
ranchers; pesticide applicators.
     Pesticide manufacturing (NAICS code 32532), e.g.,
agricultural workers; commercial applicators; farmers; greenhouse,
nursery, and floriculture workers; residential users.
    This listing is not intended to be exhaustive, but rather to
provide a guide for readers regarding entities likely to be affected by
this action. Other types of entities not listed in this unit could also
be affected. The North American Industrial Classification System
(NAICS) codes have been provided to assist you and others in
determining whether this action might apply to certain entities. If you
have any questions regarding the applicability of this action to a
particular entity, consult

the person listed under FOR FURTHER INFORMATION CONTACT.

B. How Can I Access Electronic Copies of this Document?

    In addition to accessing an electronic copy of this Federal
Register document through the electronic docket at http://www.regulations.gov
, you may access this Federal Register document

electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr. You may also access a

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

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, 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-2007-0145 in the subject line on the first page of
your submission. All requests must be in writing, and must be mailed or
delivered to the Hearing Clerk as required by 40 CFR part 178 on or
before November 26, 2007.
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit this copy, identified by docket ID number
EPA-HQ-OPP-2007-0145, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.

Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket's normal hours of operation (8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays). Special
arrangements should be made for deliveries of boxed information. The
Docket Facility telephone number is<PHONE_NUMBER>.

II. Petition for Tolerance

    In the Federal Register of May 9, 2007 (72 FR 26372) (FRL-8121-5),
EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C.
346a(d)(3), announcing the filing of a pesticide petition (PP 6E7046)
by BASF, 26 Davis Drive, Research Triangle Park, NC 27709. The petition
requested that 40 CFR 180.573 be amended by establishing a tolerance
for residues of the herbicide tepraloxdydim (2-[1-[[[(2E)-3-chloro-2-
propenyl]oxy]imino]propyl]-3-hydroxy-5-(tetrahydro-2H-pyran-4-yl)-2-
cyclohexen-1-one) and its metabolites convertible to GP (3-
(tetrahydropyran-4-yl)pentane-1,5-dioic acid) and OH-GP (3-hydroxy-3-
(tetrahydropyran-4-yl)pentane-1,5-dioic acid), calculated as
tepraloxydim, in or on imported flax, seed; lentil, seed; and pea, dry,
seed at 0.10 parts per million (ppm). That notice referenced a summary
of the petition prepared by BASF, the registrant, which is available to
the public in the docket, http://www.regulations.gov. There were no

comments received in response to the notice of filing.

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. . .
.'' These provisions were added to FFDCA by the Food Quality Protection
Act (FQPA) of 1996.
    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 the petitioned-for tolerance
for residues of tepraloxydim on imported flax, seed; lentil, seed; and
pea, dry, seed at 0.10 ppm. EPA's assessment of exposures and risks
associated with establishing the tolerance follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. Specific information on the studies received and the nature
of the adverse effects caused by tepraloxydim as well as the no-
observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-
effect-level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov.
 The referenced document is available in the docket

established by this action, which is described under ADDRESSES, and is
identified as document 3 (pages 44-47) in docket ID number EPA-HQ-OPP-
2007-0145 in that docket.

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no
appreciable risk, the toxicological level of concern (LOC) is derived
from the highest dose at which no adverse effects are observed (the
NOAEL) in the toxicology study identified as appropriate for use in
risk assessment. However, if a NOAEL cannot be determined, the lowest
dose at which adverse effects of concern are identified (the LOAEL) is
sometimes used for risk assessment. Uncertainty/safety factors (UFs)
are used in conjunction with the Point of Departure (POD) to take into
account uncertainties inherent in the extrapolation from laboratory
animal data to humans and in the variations in sensitivity among
members of the human population as well as other unknowns. Safety is
assessed for acute and chronic risks by comparing aggregate exposure to
the pesticide to the acute population adjusted dose (aPAD) and chronic
population adjusted dose (cPAD). The aPAD and cPAD are calculated by
dividing the POD by all applicable UFs. Short-, intermediate-, and
long-term risks are evaluated by comparing aggregate exposure to the
POD to ensure

that the LOC called for by the product of all applicable UFs is not
exceeded.
    For non-threshold risks, the Agency assumes that any amount of
exposure will lead to some degree of risk and estimates risk in terms
of the probability of occurrence of additional adverse cases.
Generally, cancer risks are considered non-threshold. For more
information on the general principles EPA uses in risk characterization
and a complete description of the risk assessment process, see http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm
.

    A summary of the toxicological endpoints for tepraloxydim used for
human risk assessment can be found at http://www.regulations.gov in

document 3 (pages 22-23) in docket ID number EPA-HQ-OPP-2007-0145.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to tepraloxydim, EPA considered exposure under the petitioned-
for tolerances as well as all existing tepraloxydim tolerances in (40
CFR 180.573). EPA assessed dietary exposures from tepraloxydim in food
as follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure.
    In estimating acute dietary exposure, EPA used food consumption
information from the U.S. Department of Agriculture (USDA) 1994-1996
and 1998 Nationwide Continuing Surveys of Food Intake by Individuals
(CSFII). As to residue levels in food, EPA assumed all foods for which
there are tolerances were treated and contain tolerance-level residues.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA 1994-1996
and 1998 CSFII. As to residue levels in food, EPA assumed all foods for
which there are tolerances were treated and contain tolerance-level
residues.
    iii. Cancer. Tepraloxydim is classified as ``Data are inadequate
for an assessment of human carcinogenic potential'', because there was
some evidence of liver tumors in female rats at the high dose in the
carcinogenicity phase of the study, but not in the chronic phase of the
study. Female mice developed liver tumors at an excessively toxic dose.
Male mice had non-neoplastic liver changes similar to or exceeding
those seen in female mice at the same dose, though there was no
increase in liver tumor incidences. Tepraloxydim was not mutagenic in a
battery of assays. Considering all of this evidence, tepraloxydim is
not expected to pose a cancer risk for humans, and a quantitative
cancer risk assessment was not conducted.
    iv. Anticipated residue and percent crop treated (PCT) information.
EPA did not use anticipated residues or PCT information in the dietary
assessment for tepraloxydim. The acute and chronic dietary exposure
analyses were based on tolerance level residues and 100 PCT
assumptions.
    2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring data to complete a comprehensive dietary exposure
analysis and risk assessment for tepraloxydim in drinking water.
Because the Agency does not have comprehensive monitoring data,
drinking water concentration estimates are made by reliance on
simulation or modeling, taking into account data on the environmental
fate characteristics of tepraloxydim. Further information regarding EPA
drinking water models used in pesticide exposure assessment can be
found at http://www.epa.gov/oppefed1/models/water/index.htm.

    Based on the First Index Reservoir Screening Tool (FIRST) and
Screening Concentration in Groundwater (SCI-GROW) models, the estimated
environmental concentrations (EECs) of tepraloxydim for acute exposures
are estimated to be 1.4 parts per billion (ppb) for surface water and
0.002 ppb for ground water. The EECs for chronic exposures are
estimated to be 0.7 ppb for surface water and 0.002 ppb for ground
water.
    Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For acute dietary risk
assessment, the water concentration value of 1.4 ppb was used to assess
the contribution to drinking water. For chronic dietary risk
assessment, the water concentration of value 0.7 ppb was used to assess
the contribution to drinking water.
    3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets).
    Tepraloxydim is not registered for use on any sites that would
result in residential exposure.
    4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
    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 and any other substances
and tepraloxydim does not appear to produce a toxic metabolite produced
by other substances. For the purposes of this tolerance action,
therefore, EPA has not assumed that tepraloxydim 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 website at http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408 of FFDCA provides that EPA shall apply
an additional (``10X'') tenfold 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. In
applying this provision, EPA either retains the default value of 10X
when reliable data do not support the choice of a different factor, or,
if reliable data are available, EPA uses a different additional FQPA
safety factor value based on the use of traditional UFs and/or special
FQPA safety factors, as appropriate.
    2. Prenatal and postnatal sensitivity. There were qualitative and
quantitative prenatal susceptibility in the rat developmental toxicity
study. The developmental findings with a NOAEL of 40 milligrams/
kilograms/day (mg/kg/day) were well characterized and included
increased developmental sensitivity in the form of reduced fetal body
weights, retarded ossification indicative of delayed maturation and the
presence of hydroureter at 120 mg/kg/day (developmental LOAEL). Rare
malformations (dilation of both heart ventricles and filiform tail)
were also detected at the high dose of 360 mg/kg/day. The maternal
toxicity NOAEL/LOAEL of 120/360 mg/kg/day was based on reduced body
weight gain and food

consumption. There was no evidence of increased susceptibility
following prenatal exposure to rabbits, nor was there evidence of
increased susceptibility following prenatal and/or postnatal exposure
to rats (in the rat reproduction and fertility effects study). The
degree of concern is low for the increased susceptibility seen the
developmental study in rats (prenatal exposure) since a clear NOAEL/
LOAEL was established for developmental toxicity, and since the
endpoints of concern were used for the most sensitive population of
concern (Females 13-49). There is no uncertainty for prenatal and/or
postnatal toxicity.
    3. Conclusion. The 10X FQPA safety factor was retained for
assessing the acute dietary risk to the general population (including
infants and children), due to the lack of a NOAEL in the acute
neurotoxicity study. The 10X FQPA safety factor was reduced to 1X for
assessing the acute dietary risk to females (13-49 years of age) and
for assessing the chronic dietary risk to all populations based on the
following conclusions.
    i. The toxicity database for tepraloxydim is complete.
    ii. While there are indications that tepraloxydim is neurotoxic at
doses far higher than those currently being used for the acute and
chronic dietary risk assessments, the two generation reproduction study
showed no clinical signs indicative of neurotoxicity in the parental
animals or offspring, nor was there evidence for increased
susceptibility. The Agency concluded there is no need for a
developmental neurotoxicity study or additional UFs to account for
neurotoxicity.
    iii. There are no residual concerns regarding increased sensitivity
in the young. There were no qualitative or quantitative prenatal or
postnatal susceptibility issues in the developmental toxicity study in
rabbits and 2-generation reproduction toxicity study in rats. Although
increased sensitivity was seen in the developmental rat study, the
degree of concern is low as to this finding because a clear NOAEL/LOAEL
was established for developmental toxicity, and the endpoints of
concern were used for assessing risk to the most sensitive population
of concern (Females 13-49).
    iv. The dietary food exposure assessment was performed based on
100%CT and tolerance-level residues. Conservative ground water and
surface water modeling estimates were used. The drinking water
assessment utilized values generated by models and associated modeling
parameters which are designed to provide conservative, health
protective, high-end estimates of water concentrations. These
assessments will not underestimate the exposure and risks posed by
tepraloxydim.

E. Aggregate Risks and Determination of Safety

    Safety is assessed for acute and chronic risks by comparing
aggregate exposure to the pesticide to the aPAD and cPAD. The aPAD and
cPAD are calculated by dividing the LOC by all applicable UFs. For
linear cancer risks, EPA calculates the probability of additional
cancer cases given aggregate exposure. Short-, intermediate-, and long-
term risks are evaluated by comparing the LOC to ensure that the Margin
of exposure called for by the product of all applicable UFs is not
exceeded.
    1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food and water
to tepraloxydim will occupy 2% of the aPAD for the population group
(children 1-2 years old) receiving the greatest exposure.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to
tepraloxydim from food and water will utilize 10% of the cPAD for the
population group (children 1-2 years old) receiving the greatest
exposure.
    3. Short-term risk. Short-term aggregate exposure takes into
account residential exposure plus chronic exposure to food and water
(considered to be a background exposure level). Tepraloxydim is not
registered for use on any sites that would result in residential
exposure. Therefore, the aggregate risk is the sum of the risk from
food and water, which does not exceed the Agency's level of concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account residential exposure plus chronic exposure to food
and water (considered to be a background exposure level). Tepraloxydim
is not registered for use on any sites that would result in residential
exposure. Therefore, the aggregate risk is the sum of the risk from
food and water, which do not exceed the Agency's level of concern.
    5. Aggregate cancer risk for U.S. population. Tepraloxydim is not
expected to pose a cancer risk for humans.
    6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population or to infants and children from aggregate
exposure to tepraloxydim residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology is available to enforce the
tolerance expression. The analytical method involves extraction,
concentration, precipitation, centrifugation/filtration, oxidation,
partition, and clean-up. Samples are then analyzed by GC-MS (selected
ion monitoring). The LOQ is 0.05 ppm for each analyte.
    The method may be requested from: Chief, Analytical Chemistry
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD
20755-5350; telephone number:<PHONE_NUMBER>; e-mail address:
<EMAIL_ADDRESS>

B. International Residue Limits

    No Codex maximum residue limits (MRLs) have been established for
residues of tepraloxydim on any crops at this time.

V. Conclusion

    Therefore, the tolerance is established for residues tepraloxdydim
(2-[1-[[[(2E)-3-chloro-2-propenyl]oxy]imino]propyl]-3-hydroxy-5-
(tetrahydro-2H-pyran-4-yl)-2-cyclohexen-1-one) and its metabolites
convertible to GP (3-(tetrahydropyran-4-yl)pentane-1,5-dioic acid) and
OH-GP (3-hydroxy-3-(tetrahydropyran-4-yl)pentane-1,5-dioic acid),
calculated as tepraloxydim, in or on flax, seed; lentil, seed; and pea,
dry, seed at 0.10 parts per million (ppm).

VI. Statutory and Executive Order Reviews

    This final rule establishes a tolerance under section 408(d) of
FFDCA in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). Because this rule has been
exempted from review under Executive Order 12866, this rule is not
subject to Executive Order 13211, Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355,
May 22, 2001) or Executive Order 13045, entitled Protection of Children
from Environmental Health Risks and Safety Risks (62 FR 19885, April
23, 1997). This final rule does not contain any information collections
subject to OMB approval under the Paperwork Reduction Act (PRA), 44
U.S.C. 3501 et seq., nor does it require any special considerations
under Executive Order

12898, entitled Federal Actions to Address Environmental Justice in
Minority Populations and Low-Income Populations (59 FR 7629, February
16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under section 408(d) of FFDCA, such as the tolerance in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.
    This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled Federalism (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (65 FR
67249, November 6, 2000) do not apply to this rule. In addition, this
rule does not impose any enforceable duty or contain any unfunded
mandate as described under Title II of the Unfunded Mandates Reform Act
of 1995 (UMRA) (Public Law 104-4).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272
note).

VII. Congressional Review Act

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

List of Subjects in 40 CFR Part 180

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

    Dated: September 13, 2007.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

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

PART 180--[AMENDED]

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

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

0
2. Section 180.573 is amended by alphabetically adding the following
commodities to the table in paragraph (a)(1) to read as follows:

Sec.  180.573  Tepraloxydim; tolerances for residues.

    (a) General. (1) * * *

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
                                * * * * *
Flax, seed.................................................         0.10
Lentil, seed...............................................         0.10
Pea, dry, seed.............................................         0.10
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. E7-18850 Filed 9-25-07; 8:45 am]

BILLING CODE 6560-50-S


[Federal Register Volume 87, Number 39 (Monday, February 28, 2022)]
[Notices]
[Pages 11077-11079]
[FR Doc No: 2022-04152]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance for industry, FDA staff, and other
stakeholders entitled ``Patient-Focused Drug Development: Methods To
Identify What Is Important to Patients.'' This guidance (Guidance 2) is
the second in a series of four methodological guidance documents that
FDA committed to develop to describe how to collect and submit
information from patients and caregivers to be used for medical product
development and regulatory decision making. This guidance finalizes the
draft guidance of the same title issued on October 1, 2019.

DATES: The announcement of the guidance is published in the Federal
Register on February 28, 2022.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''

    Instructions: All submissions received must include the Docket No.
FDA-2019-D-4247 for ``Patient-Focused Drug Development: Methods To
Identify What Is Important to Patients.'' Received comments will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday,<PHONE_NUMBER>.
     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.govinfo.gov/content/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,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of this guidance to the
Division of Drug Information, Center for Drug Evaluation and Research,
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale
Building, 4th Floor, Silver Spring, MD 20993-0002, or to the Office of
Communication, Outreach and Development, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance document.

FOR FURTHER INFORMATION CONTACT:  Shannon Cole, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6306, Silver Spring, MD 20993-0002, 301-
796-9208, [email protected], or Stephen Ripley, Center for
Biologics Evaluation and Research, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002,
240-402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry, FDA
staff, and other stakeholders entitled ``Patient-Focused Drug
Development: Methods To Identify What Is Important to Patients.'' This
guidance (Guidance 2) is the second in a series of four methodological
patient-focused drug development guidance documents that FDA committed
to develop to describe how stakeholders (patients, researchers, medical
product developers, and others) can collect and submit information from
patients and caregivers to be used for medical product development and
regulatory decision making. This series of guidance documents is
intended to facilitate the advancement and use of systematic approaches
to collect and use robust and meaningful patient and caregiver input
that can more consistently inform medical product development and
regulatory decision making. The purpose of Guidance 2 is to present a
range of methods and established best research practices to identify
what is important to patients with respect to burden of disease, burden
of treatment, and the benefits and risks in the management of the
patient's disease. In particular, the methods and best practices
presented can help elicit relevant information from patients and other
stakeholders, such as how their disease affects their daily lives; what
they find most troublesome; and the challenges, problems, and burdens
of the treatment for the disease.
    This guidance finalizes the draft guidance entitled ``Patient-
Focused Drug Development: Methods To Identify What Is Important to
Patients'' issued on October 1, 2019 (84 FR 52114). FDA considered
comments received on the draft guidance as the guidance was finalized.
Changes from the draft to the final guidance include incorporating the
definitions of relevant terms within the body of the document instead
of as part of a glossary. In addition, editorial changes and
methodological clarifications were made to improve clarity.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on ``Patient-Focused Drug Development: Methods
To Identify What Is Important to Patients.'' It does not establish any
rights for any person and is not binding on FDA or the public. You can
use an alternative approach if it satisfies the requirements of the
applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    This guidance refers to collections of information from individuals
under treatment or clinical examination in connection with research,
which are not subject to review by the Office of Management and Budget
(OMB) under 5 CFR 1320.3(h)(5). Therefore, clearance by the OMB under
the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. This guidance also refers to previously
approved FDA collections of information. The previously approved
collections of information are subject to review by OMB under the PRA.
The information collections described in this guidance are submitted to
FDA to support the medical product's effectiveness and to support
claims in approved medical product labeling (see 21 CFR 314.50,
314.126, and 601.2). The information collections have been approved
under OMB control numbers 0910-0001 and 0910-0338. The collections of
information in 21 CFR parts 50 and 56 have been approved under OMB
control number 0910-0130.

III. Additional Information

    Section 3002 of Title III, Subtitle A, of the 21st Century Cures
Act (Pub. L. 114-255) directs FDA to develop patient-focused drug
development guidance to address a number of areas including under
section 3002(c)(2): Methodological approaches that may be used to
develop and identify what is important to patients with respect to
burden of disease, burden of treatment, and the benefits and risks in
the

management of the patient's disease. In addition, FDA committed to meet
certain performance goals under the sixth authorization of the
Prescription Drug User Fee Act. These goal commitments were developed
in consultation with patient and consumer advocates, healthcare
professionals, and other public stakeholders, as part of negotiations
with regulated industry. Section J.1 of the commitment letter,
``Enhancing the Incorporation of the Patient's Voice in Drug
Development and Decision-Making'' (https://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM511438.pdf), outlines
work, including the development of a series of guidance documents and
associated public workshops to facilitate the advancement and use of
systematic approaches to collect and use robust and meaningful patient
and caregiver input that can more consistently inform drug development,
and, as appropriate, regulatory decision making.

IV. Electronic Access

    Persons with access to the internet may obtain the guidance at
https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances,
https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    Dated: February 22, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-04152 Filed 2-25-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: November 22, 2006 (Volume 71, Number 225)]
[Notices]
[Page 67567-67569]
[DOCID:fr22no06-65]

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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2003-0237; FRL-8102-9]

Methyl Parathion; Notice of Receipt of a Request to Voluntarily
Amend Methyl Parathion Pesticide Registrations to Terminate Uses

AGENCY:  Environmental Protection Agency (EPA).

ACTION:  Notice.

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

SUMMARY:  In accordance with section 6(f)(1) of the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA), as amended, EPA is
issuing a notice of receipt of a request by the registrant to
voluntarily amend their registration to terminate some uses from the
methyl parathion technical registration. The request would terminate
methyl parathion use in or on cabbage, dried beans, dried peas, hops,
lentils, pecans and sugar beets. The request would not terminate the
last methyl parathion product registered for use in the U.S., but would
terminate these uses on the only technical product. EPA intends to
grant this request at the close of the comment period for this
announcement unless the Agency receives substantive comments within the
comment period that would merit its further review of the request, or
unless the registrant withdraws their request within this period. Upon
acceptance of this request, any sale, distribution, or use of products
listed in this notice will be permitted only if such sale,
distribution, or use is consistent with the terms as described in the
final order.

DATES: Comments must be received on or before December 22, 2006.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2003-0237, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.

Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Building), 2777 S. Crystal Drive, Arlington, VA. Deliveries are only
accepted during the Docket's normal hours of operation (8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays). Special
arrangements should be made for deliveries of boxed information. The
Docket telephone number is<PHONE_NUMBER>.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2003-0237. EPA's policy is that all comments received will be included
in the docket without change and may be made available on-line at
http://www.regulations.gov, including any personal information

provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through regulations.gov or e-
mail. The Federal regulations.gov website is an ``anonymous access''
system, which means EPA will not know your identity or contact
information unless you provide it in the body of your comment. If you
send an e-mail comment directly to EPA without going through
regulations.gov, your e-mail address will be automatically captured and
included as part of the comment that is placed in the docket and made
available on the Internet. If you submit an electronic comment, EPA
recommends that you include your name and other contact information in
the body of your comment and with any disk or CD-ROM you submit. If EPA
cannot read your comment due to technical difficulties and cannot
contact you for clarification, EPA may not be able to consider your
comment. Electronic files should avoid the use of special characters,
any form of encryption, and be free of any defects or viruses.
    Docket: All documents in the docket are listed in the docket index.
Although listed in the index, some information is not publicly
available, e.g., CBI or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available either in the electronic docket at http://www.regulations.gov
, or, if only available in hard copy, at the OPP

Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South
Building), 2777 S. Crystal Drive, Arlington, VA. The hours of operation
of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday through
Friday, excluding legal holidays. The Docket telephone number is (703)
305-5805.

FOR FURTHER INFORMATION CONTACT: John W. Pates, Jr., Special Review and
Reregistration Division (7508P), Office of Pesticide Programs,
Environmental

Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number:<PHONE_NUMBER>; fax number:<PHONE_NUMBER>; e-
mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    This action is directed to the public in general, and may be of
interest to a wide range of stakeholders including environmental, human
health, and agricultural advocates; the chemical industry; pesticide
users; and members of the public interested in the sale, distribution,
or use of pesticides. Since others also may be interested, the Agency
has not attempted to describe all the specific entities that may be
affected by this action. If you have any questions regarding the
applicability of this action to a particular entity, consult the person
listed under FOR FURTHER INFORMATION CONTACT.

B. What Should I Consider as I Prepare My Comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or e-mail. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD ROM that you mail to EPA, mark the outside of the disk or CD ROM as
CBI and then identify electronically within the disk or CD ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When submitting comments,
remember to:
    i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
    ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
    iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
    iv. Describe any assumptions and provide any technical information
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
    vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
    viii. Make sure to submit your comments by the comment period
deadline identified.

II. Background on the Receipt of Requests to Amend Registrations to
Delete Uses

    This notice announces receipt by EPA of a request from the
registrant Cheminova A/S to amend their registration to terminate some
uses from the methyl parathion technical registration. Methyl parathion
is an insecticide/miticide for use on various terrestrial food and feed
crops to control many types of pests, including mites, thrips, weevils,
aphids, and leafhoppers. In a letter dated October 11, 2006, Cheminova
A/S requested EPA to amend the technical registration to terminate uses
of the pesticide identified in this notice (Table 1). Specifically, the
registrant has agreed to voluntarily cancel all use on cabbage, dried
beans, dried peas, hops, lentils, pecans and sugar beets. The
registrant's request will not terminate the last methyl parathion
products registered in the United States, or the last pesticide
products registered in the United States for these uses. This request
will, however, remove these uses from the only technical methyl
parathion registration. After this action is complete, a subsequent
notice will be published to amend all end-use product registrations to
remove these uses.

III. What Action is the Agency Taking?

    This notice announces receipt by EPA of a request from the
registrant to amend to terminate certain uses of methyl parathion
registrations. The affected registrations and the registrant making the
request are identified in Tables 1 and 2 of this unit.
    Under section 6(f)(1)(A) of FIFRA, registrants may request, at any
time, that their pesticide registrations be canceled or amended to
terminate one or more pesticide uses. Section 6(f)(1)(B) of FIFRA
requires that before acting on a request for voluntary cancellation,
EPA must provide a 30-day public comment period on the request for
voluntary cancellation or use termination. In addition, section
6(f)(1)(C) of FIFRA requires that EPA provide a 180-day comment period
on a request for voluntary cancellation or termination of any minor
agricultural use before granting the request, unless:
    1. The registrants request a waiver of the comment period, or
    2. The Administrator determines that continued use of the pesticide
would pose an unreasonable adverse effect on the environment.
     The methyl parathion registrant has requested that EPA waive the
180-day comment period. EPA will provide a 30-day comment period on the
proposed request.
    Unless a request is withdrawn by the registrant within 30 days of
publication of this notice, or if the Agency determines that there are
substantive comments that warrant further review of this request, an
order will be issued amending the affected registrations.

              Table 1.--Methyl Parathion Product Registrations with Pending Requests for Amendment
----------------------------------------------------------------------------------------------------------------
           Registration No.                  Product name               Company                 Use Sites
----------------------------------------------------------------------------------------------------------------
4787-33                                Methyl Parathion         Cheminova A/S            Cabbage, dried beans,
                                        Technical                                         dried peas, hops,
                                                                                lentils, pecans, and
                                                                                sugar beets
----------------------------------------------------------------------------------------------------------------

    Table 2 of this unit includes the name and address of record for
the registrant of the registrations listed in Table 1 of this unit.

     Table 2.--Registrants Requesting Voluntary Cancellation and/or
                               Amendments
------------------------------------------------------------------------
              EPA Company No.                 Company name and address
------------------------------------------------------------------------
4787                                        Cheminova, A/S Suite 700
                                            Washington Office
                                            1600 Wilson Boulevard
                                            Suite 700
                                            Arlington, VA 22209
------------------------------------------------------------------------

IV. What is the Agency's Authority for Taking this Action?

    Section 6(f)(1) of FIFRA provides that a registrant of a pesticide
product may at any time request that any of its pesticide registrations
be canceled or amended to terminate one or more uses. FIFRA further
provides that, before acting on the request, EPA must publish

a notice of receipt of any such request in the Federal Register.
Thereafter, following the public comment period, the Administrator may
approve such a request.

V. Procedures for Withdrawal of Request and Considerations for
Reregistration of Methyl Parathion

    Registrants who choose to withdraw a request for cancellation must
submit such withdrawal in writing to the person listed under FOR
FURTHER INFORMATION CONTACT, postmarked before December 22, 2006. This
written withdrawal of the request for cancellation will apply only to
the applicable FIFRA section 6(f)(1) request listed in this notice. If
the products(s) have been subject to a previous cancellation action,
the effective date of cancellation and all other provisions of any
earlier cancellation action are controlling.

VI. Provisions for Disposition of Existing Stocks

    Existing stocks are those stocks of registered pesticide products
which are currently in the United States and which were packaged,
labeled, and released for shipment prior to the effective date of the
cancellation action. If the request for voluntary cancellation and/or
use termination is granted as discussed above, the Agency intends to
issue a cancellation order that will allow persons other than the
registrant to continue to sell and/or use existing stocks of cancelled
products until such stocks are exhausted, provided that such use is
consistent with the terms of the previously approved labeling on, or
that accompanied, the cancelled product. The order will specifically
prohibit any use of existing stocks that is not consistent with such
previously approved labeling. If, as the Agency currently intends, the
final cancellation order contains the existing stocks provision just
described, the order will be sent only to the affected registrants of
the cancelled products. If the Agency determines that the final
cancellation order should contain existing stocks provisions different
than the ones just described, the Agency will publish the cancellation
order in the Federal Register.

List of Subjects

    Environmental protection, Pesticides and pests.

    Dated: November 8, 2006.
Debra Edwards,
Director, Special Review and Reregistration Division, Office of
Pesticide Programs.
[FR Doc. E6-19748 Filed 11-21-06; 8:45 am]

BILLING CODE 6560-507-S