[Federal Register Volume 79, Number 199 (Wednesday, October 15, 2014)]
[Notices]
[Pages 61865-61867]
[FR Doc No: 2014-24525]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2014-0748; FRL-9917-58]

Agricultural Pesticide Spray Drift Reduction Technologies
Voluntary Program

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: EPA's Office of Pesticides Programs (OPP) is announcing a
voluntary program to document the effectiveness of agricultural
pesticide spray application technologies on reducing pesticide spray
drift. Under the Drift Reduction Technology (DRT) Program, agricultural
equipment manufacturers would conduct (or make arrangements for a
testing facility to conduct) studies to determine the percent drift
reduction according to a verification protocol. Once completed, the
manufacturer would submit the study to EPA for review and evaluation.
As verified, these reductions could then be quantitatively credited in
the environmental risk assessments used to develop the drift reduction
measures appearing on the label of the pesticide product.

FOR FURTHER INFORMATION CONTACT: Jay Ellenberger, Field and External
Affairs Division (7506P), 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 a
pesticide application equipment manufacturer, chemical manufacturer,
pesticide registrant, university researcher, or have an interest in
reducing spray drift. 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).
     Producers of pesticide products (NAICS code 32532).
     Research and development in the physical, engineering, and
life sciences (NAICS code 541710).
     Colleges, universities, and professional schools (NAICS
code 611310).

B. How can I get copies of this document and other related information?

    The docket for this action, identified by docket identification
(ID) number EPA-HQ-OPP-2014-0748, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334,
1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is<PHONE_NUMBER>, and the telephone number for the OPP
Docket is<PHONE_NUMBER>. Please review the visitor instructions and
additional information about the docket available at http://www.epa.gov/dockets.

II. Background

A. What is the Drift Reduction Technology Program?

    Since 2006, EPA has worked collaboratively with other government
agencies, industry, and academia to develop a verification protocol for
quantitating the percent drift reduction for a particular application
technology. With this notice, EPA is announcing a voluntary program
based on this verification protocol to promote the use of technologies
that have demonstrated their effectiveness in reducing the drift of
agricultural pesticide spray application technologies. The benefits of
this voluntary program include reduced loss of pesticide from site of
application,

more deposition of the applied pesticide on the crop, improved
pesticide product efficacy, reduced costs to applicators and growers,
and reductions in overall risks.
    EPA believes there are application technologies that have the
potential to significantly reduce the amount of spray drift. Studies
conducted to measure spray drift reduction would verify the percent
reduction achieved, and thus identify these technologies. As
manufacturers become aware of the DRT Program and begin to complete
verification studies of their technologies (in accordance with the
verification protocol), the manufacturer would submit the test data to
OPP for evaluation. OPP will evaluate each data submission and, as
appropriate, assign a DRT rating to the specific technology (e.g., a
nozzle) based on the technology's spray drift characteristics as
compared to those of a standard set of nozzles. OPP will then post on
its Web site (http://www2.epa.gov/reducing-pesticide-drift) the
identification of the manufacturer, its validated technology, and the
EPA-assigned DRT rating.
    Using the information on the OPP's Web site, pesticide registrants
then have the option of submitting a draft label for review which would
include draft application instructions using DRT-rated technology on
their product labels. As part of the label approval process, EPA would
consider the rating category, (along with the appropriate drift
reduction factor), in its risk assessment and risk management
decisions. As appropriate, the approved label would contain application
instructions for use of non-DRT-rated equipment as well as one or more
categories of DRT-rated equipment. The applicator would read the label
and also refer to OPP's Web site to identify verified DRTs whose use
could be compatible with their application and then follow the label
directions for the DRT-rated technology selected for use.
    Use of DRT technologies offers the potential for fewer/reduced
application restrictions needed to mitigate spray drift from the
intended application site(s); application of more of the spray on the
target site or crop which can improve efficacy; a potential reduction
in the associated potential risks from spray drift; and a reduction in
costs to the applicator and grower (reduced potential for insurance
claims and enforcement penalties). Thus, applicators and growers will
have incentives to use these drift reduction technologies. As
applicators and growers use DRTs on a more routine basis, benefits will
accrue. Less pesticide loss to non-target sites means more of the
applied pesticides are deposited on the intended sites. This may result
in improved pesticide application efficacy, reduced costs to
applicators and growers, and reductions in overall risks.
    This is a voluntary program: No one is required to participate.
Detailed information about the voluntary DRT Program, including
approval by the Office of Management and Budget to collect this
information, is available on OPP's Web site. EPA will accept DRT
studies for review and evaluation immediately.

B. What is Pesticide Drift and why is DRT important?

    For the purpose of this notice pesticide spray drift is defined as
the physical movement of a pesticide through the air at the time of
application or soon thereafter from the target site to any non- or off-
target site. This does not include pesticide movements by erosion,
migration, volatility, or windblown soil particles after application.
Spray drift is dependent on the design of application equipment, size
of spray droplets, weather conditions, and other factors.
    Today, there is increased sensitivity to spray drift due to
increased suburban development in agricultural areas, and protection of
endangered species. Spray drift management is of interest to pesticide
and other chemical manufacturers, application equipment manufacturers,
pesticide applicators, government agencies, advocacy groups, and the
public. Generally, applications of most if not all sprays result in
some amount of drift. It is not possible to completely eliminate drift.

C. Description of the DRT Program

    The following is an outline of the DRT Program:
     Agricultural equipment manufacturers contract with a
testing facility (or use their own facility) to test their technology
using the verification protocol.
     Manufacturers then submit studies to OPP for review and
evaluation.
     OPP verifies the adequacy of the study and determines the
potential for the technology to reduce drift compared to a reference.
     OPP assigns a `star' rating to the technology.
     Rating is posted on OPP's Web site.
     Pesticide registrant submits a proposed label that offers
an alternative application process that specifies the use of a DRT with
`star' rating.
     OPP evaluates the proposed label and conducts the
environmental risk assessment using assumptions appropriate for the
`star' rating/application technology.
     If appropriate, OPP may also approve the label with two
sets of application restrictions: One set of restrictions if the
product is applied without DRT and another set of restrictions if the
product is applied with a DRT.

D. What is a `Star' rating?

    As appropriate, each verified technology is assigned to one of four
drift reduction categories represented by stars:
     Less than 25% reduction = No DRT rating.
     25 to 49% reduction = DRT* rating.
     50 to 74% reduction = DRT** rating.
     75 to 89% reduction = DRT*** rating.
     Equal to or greater than 90% reduction = DRT**** rating.

E. Benefits of the Voluntary DRT Program

    Use of verified DRTs in the application of pesticides has the
potential for significant benefits.
    1. Benefits to growers and applicators would include:
     Substantiated, accepted performance claims of the verified
technologies.
     Greater deposition of applied pesticides on the target
sites/crops which may result in improved efficacy of pest or weed
control.
     With greater on-target deposition, potential reductions in
application rates with a commensurate reduction in application costs.
     Reduction of the currently estimated application
restrictions for preventing adverse effects (e.g., smaller or no buffer
zones).
     Applications can be made with increased flexibility in
application timing and options potentially saving applicators time and
costs: This means applications under a wider range of environmental and
application method conditions.
     Reduced spray drift resulting in fewer incidents of
adverse effects: This means fewer claims of violations of pesticide
labeling requirements that need to be investigated by enforcement
authorities, reduction in enforcement violation penalties, and less
litigation and associated costs, including insurance claim costs.
    2. Benefits to manufacturers and pesticide registrants would
include:
     Increased demand for DRT-rated equipment and pesticide
products offering the option of DRT application methods on the label as
applicators and

growers use DRTs on a more routine basis.
    3. Benefits to the public and the environment would include:
     Fewer incidents of adverse effects from spray drift to
humans, and terrestrial and aquatic organisms and ecosystems, including
threatened or endangered species.

F. Next Steps

    Once the submitted DRT studies have been reviewed and evaluated by
OPP, and the results are posted on the Agency's Web site, then
pesticide registrants have the option of amending their label to
include DRT-rated application methods. This requires the submission of
a complete application including a Pesticide Registration Improvement
Act (PRIA) fee, or request for waiver or reduction. OPP will complete
its review of the amendment according to the PRIA timeframe.

    Authority: 7 U.S.C. 136 et seq.

    Dated: October 8, 2014.
Jack E. Housenger,
Director, Office of Pesticide Programs.
[FR Doc. 2014-24525 Filed 10-14-14; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 84, Number 195 (Tuesday, October 8, 2019)]
[Rules and Regulations]
[Pages 53601-53602]
[FR Doc No: 2019-21552]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R05-OAR-2016-0343; FRL-10000-66-Region 5]

Air Plan Approval; Indiana; Infrastructure SIP Requirements for
the 2012 PM2.5 NAAQS; Interstate Transport

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: The Environmental Protection Agency (EPA) is approving
elements of a State Implementation Plan (SIP) submission from Indiana
regarding the infrastructure requirements of section 110 of the Clean
Air Act (CAA) for the 2012 annual fine particulate matter
(PM2.5) National Ambient Air Quality Standard (NAAQS). The
infrastructure requirements are designed to ensure that the structural
components of each state's air quality management program are adequate
to meet the state's responsibilities under the CAA. This action
pertains specifically to infrastructure requirements concerning
interstate transport provisions. EPA did not receive any adverse
comments in response to its July 30, 2019 proposal to approve this
submission.

DATES: This final rule is effective on November 7, 2019.

ADDRESSES: EPA has established a docket for this action under Docket ID
No. EPA-R05-OAR-2016-0343. All documents in the docket are listed on
the www.regulations.gov website. Although listed in the index, some
information is not publicly available, i.e., 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 either
through www.regulations.gov or at the Environmental Protection Agency,
Region 5, Air and Radiation Division, 77 West Jackson Boulevard,
Chicago, Illinois 60604. This facility is open from 8:30 a.m. to 4:30
p.m., Monday through Friday, excluding Federal holidays.

FOR FURTHER INFORMATION CONTACT: Samantha Panock, Environmental
Scientist, Attainment Planning and Maintenance Section, Air Programs
Branch (AR-18J), Environmental Protection Agency, Region 5, 77 West
Jackson Boulevard, Chicago, Illinois 60604,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document whenever ``we,''
``us,'' or ``our'' is used, we mean EPA. This supplementary information
section is arranged as follows:

I. What is the background for this action?
II. What comments did we receive on the proposed action?
III. What action is EPA taking?
IV. Statutory and Executive Order Reviews

I. What is the background for this action?

    On June 10, 2016, the Indiana Department of Environmental
Management (IDEM) submitted a request for EPA to approve its
infrastructure SIP for the 2012 annual PM2.5 NAAQS. The June
10, 2016 IDEM submittal included a technical analysis of its interstate
transport of pollution relative to the 2012 PM2.5 NAAQS that
demonstrates that current controls are adequate for Indiana to show
that it meets prongs one and two of the ``good neighbor'' provision \1\
under CAA section 110(a)(2)(D)(i). On July 30, 2019 (84 FR 36848), EPA
proposed to approve the portion of the submission dealing with those
requirements.
---------------------------------------------------------------------------

    \1\ There are four prongs to the Section 110(a)(2)(D)(i) ``good
neighbor'' provision, which are: Prohibit any source or other type
of emissions activity in one state from contributing significantly
to nonattainment of the NAAQS in another state (prong one); prohibit
any source or other type of emissions activity in one state from
interfering with maintenance of the NAAQS in another state (prong
two); prohibit any source or other type of emissions activity in one
state from interfering with measures required to prevent significant
deterioration (PSD) of air quality in another state (prong three);
and protect visibility in another state (prong four).
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II. What comments did we receive on the proposed action?

    Our July 30, 2019 proposed rule provided a 30-day review and
comment period. The comment period closed on August 29, 2019. EPA did
not receive any comments.

III. What action is EPA taking?

    In this action, EPA is approving the portion of Indiana's June 10,
2016, submission certifying that the current Indiana SIP is sufficient
to meet the required infrastructure requirements under CAA section
110(a)(2)(D)(i), specifically prongs one and two of the ``good
neighbor'' provisions, with respect to the 2012 PM2.5 NAAQS.

VI. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the

CAA and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR
52.02(a). Thus, in reviewing SIP submissions, EPA's role is to approve
state choices, provided that they meet the criteria of the CAA.
Accordingly, this action merely approves state law as meeting Federal
requirements and does not impose additional requirements beyond those
imposed by state law. For that reason, this action:
     Is not a significant regulatory action subject to review
by the Office of Management and Budget under Executive Orders 12866 (58
FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
     Is not an Executive Order 13771 (82 FR 9339, February 2,
2017) regulatory action because SIP approvals are exempted under
Executive Order 12866;
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Public Law 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, the SIP is not approved to apply on any Indian
reservation land or in any other area where EPA or an Indian tribe has
demonstrated that a tribe has jurisdiction. In those areas of Indian
country, the rule does not have tribal implications and will not impose
substantial direct costs on tribal governments or preempt tribal law as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000).
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this action 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. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by December 9, 2019. Filing a petition for
reconsideration by the Administrator of this final rule does not affect
the finality of this action for the purposes of judicial review nor
does it extend the time within which a petition for judicial review may
be filed and shall not postpone the effectiveness of such rule or
action. This action may not be challenged later in proceedings to
enforce its requirements. (See section 307(b)(2).)

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Particulate matter, Reporting
and recordkeeping requirements.

    Dated: September 19, 2019.
Cathy Stepp,
Regional Administrator, Region 5.

    40 CFR part 52 is amended as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

0
1. The authority citation for part 52 continues to read as follows:

    Authority: 42 U.S.C. 7401 et seq.

0
2. In Sec.  52.770, the table in paragraph (e) is amended by revising
the entry for ``Section 110(a)(2) infrastructure requirements for the
2012 PM2.5 NAAQS'' to read as follows:

Sec.  52.770  Identification of plan.

* * * * *
    (e) * * *

                       EPA-Approved Indiana Nonregulatory and Quasi-Regulatory Provisions
----------------------------------------------------------------------------------------------------------------
               Title                      Indiana date            EPA approval               Explanation
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
Section 110(a)(2) infrastructure     6/10/2016 and 12/28/    10/8/2019, [Insert      Fully approved for all CAA
 requirements for the 2012 PM2.5      2016.                   Federal Register        elements except the
 NAAQS.                                                       citation].              visibility protection
                                                                                requirements of
                                                                                (D)(i)(II).

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

* * * * *
[FR Doc. 2019-21552 Filed 10-7-19; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register: June 28, 2011 (Volume 76, Number 124)]
[Rules and Regulations]
[Page 37646]
[DOCID:fr28jn11-11]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG 2011-0208]

Safety Zone; Northern California Annual Fireworks Events, Fourth
of July Fireworks, Lake Tahoe, CA

AGENCY: Coast Guard, DHS.

ACTION: Notice of enforcement of regulation.

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SUMMARY: The Coast Guard will enforce the annual safety zone for the
Fourth of July Fireworks, Lake Tahoe, California, located off Incline
Village in Crystal Bay. This action is necessary to control vessel
traffic and to ensure the safety of event participants and spectators.
During the enforcement period, unauthorized persons or vessels are
prohibited from entering into, transiting through, or anchoring in the
safety zone, unless authorized by the Patrol Commander (PATCOM).

DATES: The regulations in 33 CFR 165.1191 will be enforced from 9 p.m.
to 9:30 p.m. on July 4, 2011.

FOR FURTHER INFORMATION CONTACT: If you have questions on this notice,
call or e-mail Lieutenant Junior Grade Liezl Nicholas, U.S. Coast
Guard, Waterways Safety Division; telephone<PHONE_NUMBER>, e-mail D11-
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The Coast Guard will enforce the 1,000 foot
safety zone for the annual Fourth of July Fireworks Display in 33 CFR
165.1191 on July 4, 2011. The fireworks launch site is approximately
800 feet off the shore line of Incline Village Nevada in Crystal Bay in
position 39[deg]14'16.50'' N, 119[deg]53'59.43'' W (NAD83).
    Under the provisions of 33 CFR 165.1191, unauthorized persons or
vessels are prohibited from entering into, transiting through, or
anchoring in the safety zone during all applicable effective dates and
times, unless authorized to do so by the PATCOM. Additionally, each
person who receives notice of a lawful order or direction issued by an
official patrol vessel shall obey the order of direction. The PATCOM is
empowered to forbid entry into and control the regulated area. The
PATCOM shall be designated by the Commander, Coast Guard Sector San
Francisco. The PATCOM may, upon request, allow the transit of
commercial vessels through regulated areas when it is safe to do so.
    This notice is issued under authority of 33 CFR 165.1191 and 5
U.S.C. 552(a). In addition to this notice in the Federal Register, the
Coast Guard will provide the maritime community with extensive advance
notification of this enforcement period via the Local Notice to
Mariners.
    If the Captain of the Port determines that the regulated area need
not be enforced for the full duration stated in this notice, a
Broadcast Notice to Mariners may be used to grant general permission to
enter the regulated area.

    Dated: June 16, 2011.
Cynthia L. Stowe,
Captain, U.S. Coast Guard, Captain of the Port San Francisco.
[FR Doc. 2011-16107 Filed 6-27-11; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register: November 25, 2009 (Volume 74, Number 226)]
[Notices]
[Page 61681-61683]
[DOCID:fr25no09-69]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2009-0787; FRL-8798-6]

Difenzoquat; Notice of Receipt of Request to Voluntarily Cancel
Pesticide Registrations

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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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 cancel
their registrations of products containing the pesticide difenzoquat.
The request would terminate difenzoquat use on barley and wheat. The
request would terminate the last difenzoquat products registered for
use in the United States. 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 28, 2009.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2009-0787, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket Facility's normal hours of operation (8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays).
Special arrangements should be made for deliveries of boxed
information. The Docket Facility telephone number is<PHONE_NUMBER>.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2009-0787. 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 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
available at http://www.regulations.gov. 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 Bldg.), 2777 S. Crystal Dr., 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 Facility telephone
number is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Eric Miederhoff, Pesticide Re-
evaluation 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 Cancel and/or Amend
Registrations to Delete Uses

    This notice announces receipt by EPA of a request from registrant
AMVAC Chemical Corporation to cancel all 3 product registrations for
the herbicide difenzoquat. Difenzoquat is registered for use on only
two crops, wheat and barley. In a letter dated November 2, 2009, AMVAC
Chemical Corporation requested EPA to cancel the affected product
registrations identified in Table 1 of this notice. If the registrant's
request is granted, the last difenzoquat products registered in the
United States will be canceled effective December 31, 2009.

III. What Action is the Agency Taking?

    This notice announces receipt by EPA of a request from a registrant
to cancel difenzoquat product registrations. The affected products and
the registrants making the requests are identified in Table 1 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: The registrants
request a waiver of the comment period, or; the Administrator
determines that continued use of the pesticide would pose an
unreasonable adverse effect on the environment.
    The difenzoquat registrants have requested that EPA waive the 180-
day comment period. EPA will provide a 30-day comment period on the
proposed requests.
    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 canceling the affected registrations.

 Table 1. -- Difenzoquat Product Registrations with Pending Requests for
                              Cancellation
------------------------------------------------------------------------
       Registration Number           Product Name           Company
------------------------------------------------------------------------
5481-536                          Avenge Technical    AMVAC Chemical
                                   Herbicide           Corporation
------------------------------------------------------------------------
5481-537                          Avenge Wild Oat     AMVAC Chemical
                                   Herbicide           Corporation
------------------------------------------------------------------------
5481-538                          Avenge SG Wild Oat  AMVAC Chemical
                                   Herbicide           Corporation
------------------------------------------------------------------------

    Table 2, of this unit includes the name and address of record for
the

registrant of the products listed in Table 1 of this unit.

     Table 2. -- Registrant Requesting Voluntary Cancellation and/or
                               Amendments
------------------------------------------------------------------------
            EPA Company Number                Company Name and Address
------------------------------------------------------------------------
5481                                        AMVAC Chemical Corporation,
                                            4695 Macarthur Court, Suite
                                             1250,
                                            Newport Beach, CA 92660-1706
------------------------------------------------------------------------

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 Difenzoquat

    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 28, 2009. 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 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.
    In any order issued in response to these requests for cancellation
of difenzoquat product registrations, EPA proposes to include the
following provisions for the treatment of any existing stocks of the
products identified or referenced in Table 1 in Unit III.
    If the request for voluntary cancellation is granted as discussed
in this unit, the Agency proposes to issue a cancellation order that
will allow AMVAC to sell and distribute existing stocks of the products
identified in Unit III. until December 31, 2010. All sale or
distribution of existing stocks by AMVAC is prohibited after December
30, 2010, unless that sale or distribution is solely for the purpose of
facilitating disposal or export of the product.
    The Agency will allow persons other than the registrant to continue
to sell and/or use existing stocks of canceled 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
canceled product. The order will specifically prohibit any use of
existing stocks that is not consistent with such previously approved
labeling. The Agency will publish the cancellation order in the Federal
Register.

List of Subjects

    Environmental protection, Pesticides and pests.

    Dated: November 12, 2009.
Peter Caulkins,
Acting Director, Pesticide Re-evaluation Division, Office of Pesticide
Programs.

[FR Doc. E9-28057 Filed 11-24-09; 8:45 am]

BILLING CODE 6560-50-S


[Federal Register Volume 86, Number 168 (Thursday, September 2, 2021)]
[Notices]
[Pages 49334-49337]
[FR Doc No: 2021-18928]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-N-0874]

Proposal To Refuse To Approve a New Drug Application for ITCA 650
(Exenatide in DUROS Device); Opportunity for a Hearing

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Director of the Center for Drug Evaluation and Research
(Center Director) at the Food and Drug Administration (FDA or Agency)
is proposing to refuse to approve a new drug application (NDA)
submitted by Intarcia Therapeutics, Inc. (Intarcia), for ITCA 650
(exenatide in DUROS device) in its present form. This notice summarizes
the grounds for the Center Director's proposal and offers Intarcia an
opportunity to request a hearing on the matter.

DATES: Submit either electronic or written requests for a hearing by
October 4, 2021; submit data, information, and analyses in support of
the hearing and any other comments by November 1, 2021.

ADDRESSES: You may submit hearing requests, documents in support of the
hearing, and any other comments as follows. Please note that late,
untimely filed requests and documents will not be considered.
Electronic requests for a hearing must be submitted on or before
October 4, 2021; electronic documents in support of the hearing and any
other comments must be submitted on or before November 1, 2021. The
https://www.regulations.gov electronic filing system will accept
hearing requests until 11:59 p.m. Eastern Time at the end of October 4,
2021, and will accept documents in support of the hearing and any other
comments until 11:59 p.m. Eastern Time at the end of November 1, 2021.
Documents received by mail/hand delivery/courier (for written/paper
submissions) will be considered timely if they are postmarked or the
delivery service acceptance receipt is on or before these dates.

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-2021-N-0874 for ``Proposal To Refuse To Approve a New Drug
Application for ITCA 650 (Exenatide in DUROS Device); Opportunity for a
Hearing.'' Received comments, those filed in a timely manner (see
ADDRESSES), will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday,<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>.

FOR FURTHER INFORMATION CONTACT: Kevin Fain, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 22, Rm. 6419, Silver Spring, MD 20993,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Proposal To Refuse To Approve NDA 209053

    Intarcia submitted NDA 209053 for ITCA 650 (exenatide in DUROS
device), a drug-device combination product intended to deliver the
active ingredient exenatide, a GLP-1 receptor agonist (RA), on November
21, 2016, under section 505(b)(1) of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C. 355(b)(1)). Intarcia proposed that
ITCA 650 be indicated as an adjunct to diet and exercise to improve
glycemic control in adults with type 2 diabetes mellitus (T2DM).
    On September 21, 2017, the former Division of Metabolism and
Endocrinology Products (DMEP), Office of Drug Evaluation II (now the
Division of Diabetes, Lipid Disorders, and Obesity, within the Office
of Cardiology, Hematology, Endocrinology and Nephrology (OCHEN)) in the
Office of New Drugs (OND) in FDA's Center for Drug Evaluation and
Research (CDER), issued a complete response letter to Intarcia under
Sec.  314.110(a) (21 CFR 314.110(a)) stating that NDA 209053 could not
be approved in its present form, describing the specific deficiencies
and, where possible, recommending ways that Intarcia might remedy these
deficiencies. On September 9, 2019, Intarcia resubmitted the NDA under
section 505(b)(1) of the FD&C Act. On March 9, 2020, the former DMEP
issued a second complete response letter stating that NDA 209053 could
not be approved in its present form, describing the specific
deficiencies and, where possible, recommending ways that Intarcia might
remedy these deficiencies. These deficiencies, which are summarized
below, include the following:
    1. The clinical trial data demonstrated that ITCA 650 causes acute
kidney injury (AKI).
    a. A signal of AKI was evident in the pivotal phase 3 trials of the
ITCA 650 clinical development program. A standardized Medical
Dictionary for Regulatory Activities query for acute renal failure
identified reports of AKI serious adverse events in 14 subjects (0.6
percent) who received ITCA 650 versus 4 subjects (0.2 percent) who
received placebo.
    b. The magnitude of the AKI risk was greater for ITCA 650 than for
the marketed exenatide products or for other members of the GLP-1 RA
class. Although other drugs in the GLP-1 RA class have a risk of AKI,
this information is based on spontaneous postmarketing adverse event
reports. The risk of AKI was not detected in the clinical trials that
supported the approval of these drugs. In contrast, the risk of AKI was
clearly identified in the ITCA 650 clinical trial data. This AKI risk
for ITCA 650, compared to other members of the GLP-1 RA class, is
particularly concerning because it was identified from these adequate
and well-controlled clinical trials, which constitute stronger evidence
for assessing a drug's safety than spontaneous postmarketing adverse
event reports.
    c. AKI events experienced by participants who received ITCA 650
sometimes resulted in prolonged hospitalization; complications observed
in association with AKI events included dialysis and death.
    d. A majority of the serious AKI events in participants randomized
to ITCA 650 appeared to be associated with vomiting, diarrhea, and
dehydration, which are known adverse

reactions associated with exenatide therapy, supporting a causal
relationship between ITCA 650 and AKI.
    e. Intarcia's proposed risk mitigation measures were inadequate and
sufficient risk mitigation approaches could not be identified for the
AKI risk identified in the clinical trial data, particularly because
serious AKI events occurred in participants who received ITCA 650 who
did not have known risk factors (moderate to severe renal impairment or
use of concomitant medications that increase the risk of AKI) and
serious AKI events were observed with use of both the nominal initial/
reduced dose ITCA 650, 20 micrograms (mcg)/day, and the nominal
maintenance dose ITCA 650, 60 mcg/day.
    2. The cardiovascular risk assessment failed to provide sufficient
assurance that ITCA 650 is not associated with excess cardiovascular
(CV) risk. Rather, the clinical trial data suggested that ITCA 650 may
be associated with an increased risk for major adverse cardiovascular
events (MACE), defined as myocardial infarction, nonfatal stroke, and
cardiovascular death.
    a. A prespecified meta-analysis incorporated the data from clinical
trials CLP-103, CLP-105, and CLP-107, and included 181 MACE and
unstable angina (UA) events. An unfavorable point estimate of 1.12 was
observed [hazard ratio (HR) for MACE + UA; 1.12 (95 percent confidence
interval (CI): 0.83, 1.51)].
    b. Furthermore, estimates of CV risk from the meta-analysis were
notably higher and nominally statistically significant in the subgroup
of participants 65 years of age or older [HR for MACE + UA; 1.67 (95
percent CI: 1.02, 2.71)]. Subgroup analyses also suggested an
interaction between CV risk and baseline renal function, where the HR
estimates trended higher with worse renal function.
    c. The CV risk analyses from trial CLP-107 augmented the concern
that the drug is associated with a higher risk for MACE. CLP-107 was a
randomized, double-blind, placebo-controlled cardiovascular outcomes
trial (CVOT) conducted in a patient population at high risk of MACE.
CLP-107 contributed 174 of the 181 total MACE + UA events observed in
the CV risk meta-analysis. In CLP-107, the assessment of product-
related CV risk yielded an HR for MACE of 1.24 (95 percent CI: 0.90,
1.70).
    d. This CV risk resulting from ITCA 650 use is particularly
concerning when compared to the beneficial effect of other drugs in
this class on CV outcomes. In contrast to the unfavorable CVOT results
for ITCA 650, some other GLP-1 RA products carry indications for MACE
risk reduction in patients with T2DM based on favorable results of
CVOTs. The MACE HR observed in a CVOT conducted for another formulation
of exenatide was 0.91 (95 percent CI: 0.83, 1.0). The lower bound of
the CLP-107 confidence interval (0.90) nearly excludes the point
estimate for MACE risk observed with this other product (0.91),
suggesting a true difference in MACE risk between the products.
    3. The data provided to validate the limits of the in vitro dose
delivery specifications did not support the safe and effective use of
the device constituent of ITCA 650.
    a. The device design validation data did not support the proposed
daily, weekly, and biweekly in vitro drug-release specifications as
appropriate for the intended use.
    b. The in vitro device performance data demonstrated inconsistent
day-to-day drug delivery and did not support that weekly and biweekly
in vitro drug-release testing is adequate to ensure controlled in vivo
drug release by the device constituent of ITCA 650.
    4. The data provided, inclusive of delivery performance data and
failure analyses, did not demonstrate adequate device reliability
associated with in vitro dose delivery to support safety and
effectiveness for the intended use.
    a. Variability in the daily in vitro drug-release data did not
support the use of weekly and biweekly averages to calculate device
failure rates.
    b. The failure rate data was inadequate to support the safety and
effectiveness of the device constituent of ITCA 650.
    c. The sponsor provided inadequate mitigation strategies to reduce
device failures.
    5. The information provided, including the following, was
inadequate in support of sterility assurance for ITCA 650:
    a. The container-closure integrity test data provided to support
integrity of a container-closure system used for sterile intermediate
storage of sterile components of ITCA 650.
    b. Information regarding the product-contact filling equipment used
for commercial manufacturing of ITCA 650.
    c. Information provided to support the routine depyrogenation
process for components of the primary container-closure system for ITCA
650.
    d. The method suitability data provided to support the proposed
routine endotoxins test method with ITCA 650.
    6. An FDA inspection of the Intarcia manufacturing facility
identified deficiencies with the manufacturing practices for ITCA 650
that were not adequately addressed.
    a. Controls were inadequate to ensure empty devices would not be
included in the final release of ITCA 650.
    b. Qualification of the filling line with an original or new
manifold was not performed.
    c. The results and reports of the process simulation test, used to
demonstrate the effectiveness of preventing microbiological
contamination of ITCA 650, were not provided.
    The complete response letters issued on September 21, 2017, and
March 9, 2020, both stated that to address the clinical deficiencies,
Intarcia should address all the specific device and product quality-
related deficiencies and provide additional clinical data that
adequately address the clinical risks and establish that ITCA 650 is
safe and effective for the intended use. The complete response letters
stated that Intarcia is required either to resubmit the application,
fully addressing all deficiencies listed in the letter, or take other
actions available under Sec.  314.110 (i.e., withdraw the application
or request an opportunity for a hearing). Applicable regulations,
including 21 CFR 10.75, also provide a mechanism for applicants to
obtain formal review of one or more decisions reflected in a complete
response letter (see FDA's guidance for industry and review staff
``Formal Dispute Resolution: Sponsor Appeals Above the Division Level''
(November 2017)).\1\
---------------------------------------------------------------------------

    \1\ Available at https://www.fda.gov/media/126910/download. FDA
updates guidances periodically. For the most recent version of a
guidance, check the FDA guidance web page at https://www.fda.gov/regulatory-information/search-fda-guidance-documents.
---------------------------------------------------------------------------

    Intarcia submitted a formal dispute resolution request (FDRR) on
June 5, 2020, concerning the complete response letter issued on March
9, 2020, by the former DMEP. Ellis Unger, Director of OND's OCHEN,
denied the FDRR by correspondence dated July 30, 2020, based on his
determination that the drug's unexpected numeric imbalance in cases of
serious AKI, the MACE observed in the CVOT, and device-related
deficiencies regarding exenatide release rates over the life of the
product outweighed the benefit in reductions in Hemoglobin A1c.
Intarcia submitted another FDRR on August 14, 2020, for review of the
OCHEN denial. Robert Temple, Senior Advisor to OND, denied the second
FDRR on behalf of OND by correspondence dated October 30, 2020,

based on his determination that the drug's clinical risks, device-
related deficiencies, and product quality and manufacturing
deficiencies had not been satisfactorily resolved, reaffirming the
reasoning in OCHEN's denial of the prior FDRR. Intarcia submitted a
third FDRR on November 27, 2020, for review of the OND denial and
requested an advisory committee meeting. Douglas Throckmorton, Deputy
Director for Regulatory Programs, CDER, denied the third FDRR and the
request for an advisory committee meeting on behalf of CDER by
correspondence dated February 12, 2021, based on his determination that
the drug's clinical risks and device-related deficiencies had not been
satisfactorily resolved, reaffirming the reasoning in OND's denial of
the prior FDRR, and determined that an advisory committee would be
premature because of these unresolved safety issues.
    On March 16, 2021, Intarcia submitted a request for an opportunity
for a hearing under Sec.  314.110(b)(3) on whether there are grounds
under section 505(d) of the FD&C Act for denying approval of NDA
209053.

II. Notice of Opportunity for a Hearing

    For the reasons stated above and as explained in further detail in
the March 9, 2020, complete response letter and the February 12, 2021,
November 27, 2020, and July 30, 2020, FDRR denials, notice is given to
Intarcia and all other interested persons that the Center Director
proposes to issue an order refusing to approve NDA 209053 on the
grounds that the application fails to meet the criteria for approval
under section 505(d) of the FD&C Act, including the following: (1) Data
submitted in the application do not show that the product would be safe
under the proposed conditions of use (section 505(d)(2) of the FD&C
Act) and (2) the methods used in, and the facilities and controls used
for, the manufacture, processing, or packing of the product are not
shown to be adequate to preserve its identity, strength, quality, and
purity (section 505(d)(3) of the FD&C Act).
    Intarcia may request a hearing before the Commissioner of Food and
Drugs (the Commissioner) on the Center Director's proposal to refuse to
approve NDA 209053. If Intarcia decides to seek a hearing, it must
file: (1) A written notice of participation and request for a hearing
(see the DATES section) and (2) the studies, data, information, and
analyses relied upon to justify a hearing (see the DATES section), as
specified in Sec.  314.200 (21 CFR 314.200).
    As stated in Sec.  314.200(g), a request for a hearing may not rest
upon mere allegations or denials, but must present specific facts
showing that there is a genuine and substantial issue of fact that
requires a hearing to resolve. We note in this regard that because CDER
proposes to refuse to approve NDA 209053 based on the multiple
deficiencies summarized above, any hearing request from Intarcia must
address all of those deficiencies. Failure to request a hearing within
the time provided and in the manner required by Sec.  314.200
constitutes a waiver of the opportunity to request a hearing. If a
hearing request is not properly submitted, FDA will issue a notice
refusing to approve NDA 209053.
    The Commissioner will grant a hearing if there exists a genuine and
substantial issue of fact or if the Commissioner concludes that a
hearing would otherwise be in the public interest (Sec.
314.200(g)(6)). If a hearing is granted, it will be conducted according
to the procedures provided in 21 CFR parts 10 through 16 (21 CFR
314.201).
    Paper submissions under this notice of opportunity for a hearing
should be filed in one copy, except for those submitted as
``Confidential Submissions'' (see ``Written/Paper Submissions'' and
``Instructions''). Except for data and information prohibited from
public disclosure under 21 U.S.C. 331(j) or 18 U.S.C. 1905, submissions
may be seen in the Dockets Management Staff Office between 9 a.m. and 4
p.m., Monday through Friday, and on the internet at https://www.regulations.gov. This notice is issued under section 505(c)(1)(B)
of the FD&C Act and Sec. Sec.  314.110(b)(3) and 314.200.

    Dated: August 27, 2021.
Jacqueline Corrigan-Curay,
Principal Deputy Center Director, Center for Drug Evaluation and
Research.
[FR Doc. 2021-18928 Filed 9-1-21; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 80, Number 13 (Wednesday, January 21, 2015)]
[Rules and Regulations]
[Pages 2817-2819]
[FR Doc No: 2014-30914]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2014-0530; Directorate Identifier 2014-NM-062-AD;
Amendment 39-18057; AD 2014-26-06]
RIN 2120-AA64

Airworthiness Directives; ATR--GIE Avions de Transport
R[eacute]gional Airplanes

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Final rule.

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

SUMMARY: We are adopting a new airworthiness directive (AD) for certain
ATR--GIE Avions de Transport R[eacute]gional Model ATR42-500 airplanes,
and Model ATR72-212A airplanes. This AD was prompted by a report that,
during an inspection of an airplane on the production line,
interference was detected between the electrical harness and a bonding
lead due to an incorrect installation of the affected bonding lead.
This AD requires a detailed inspection for damage or incorrect routing
of the bonding lead routing above the 120VU shelf, and if any damage or
incorrect routing is found, repairing damage or modifying the bonding
lead routing. We are issuing this AD to detect and correct installation
of the bonding lead, which could cause arcing and chafing, and could
possibly result in an uncontrolled fire.

DATES: This AD becomes effective February 25, 2015.
    The Director of the Federal Register approved the incorporation by
reference of certain publications listed in this AD as of February 25,
2015.

ADDRESSES: You may examine the AD docket on the Internet at http://www.regulations.gov/#!docketDetail;D=FAA-2014-0530 or in person at the
Docket Management Facility, U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC.
    For service information identified in this AD, contact ATR--GIE
Avions de Transport R[eacute]gional, 1, All[eacute]e Pierre Nadot,
31712 Blagnac Cedex, France; telephone +33 (0) 5 62 21 62 21; fax +33
(0) 5 62 21 67 18; email<EMAIL_ADDRESS>Internet
http://www.aerochain.com. You may view this referenced service
information at the FAA, Transport Airplane Directorate, 1601 Lind
Avenue SW., Renton, WA. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Tom Rodriguez, Aerospace Engineer,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
1601 Lind Avenue SW., Renton, WA 98057-3356; telephone<PHONE_NUMBER>;
fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 by adding an AD that would apply to certain ATR--GIE Avions de
Transport R[eacute]gional Model ATR42-500 airplanes, and Model ATR72-
212A airplanes. The NPRM published in the Federal Register on August
13, 2014 (79 FR 47390).
    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Community, has issued
Airworthiness Directive 2014-0056, dated March 7, 2014 (referred to
after this as the Mandatory Continuing Airworthiness Information, or
``the MCAI''), to correct an unsafe condition for certain ATR--GIE
Avions de Transport R[eacute]gional Model ATR42-500 airplanes, and
Model ATR72-212A airplanes. The MCAI states:

    During inspection of an aeroplane on the production line,
interference was detected between electrical harnesses (2M-2S-6M)
and a bonding lead, located in zone 214, positioned above and
forward of the 120VU shelf. Subsequent investigation revealed that
the interference was a result of an incorrect installation of the
affected bonding lead.
    This condition, if not detected and corrected, could lead to
arcing and chafing, possibly resulting in an uncontrolled fire.
    To address this potential unsafe condition, ATR issued Service
Bulletin (SB) ATR42-92-0025 and SB ATR72-92-1034, as applicable to
aeroplane model, to provide inspection instructions.
    For the reasons described above, this [EASA] AD requires a one-
time [detailed] inspection [for damage or incorrect routing of the
bonding lead routing above the 120VU shelf] of the electrical
harness 2M-2S-6M in zone 214 and, depending on findings,
accomplishment of corrective action(s) [repairing damage or
modifying the bonding lead routing].

    You may examine the MCAI in the AD docket on the Internet at http://www.regulations.gov/#!documentDetail;D=FAA-2014-0530-0002.

Comments

    We gave the public the opportunity to participate in developing
this AD. We received no comments on the NPRM (79

FR 47390, August 13, 2014) or on the determination of the cost to the
public.

Clarification of Corrective Actions

    In paragraph (h) of the NPRM (79 FR 47390, August 13, 2014), we
specify modifying the bonding lead routing if any damage or incorrect
routing is found and we refer to ATR Service Bulletin ATR42-92-0025,
dated November 7, 2013; and ATR Service Bulletin ATR72-92-1034, dated
November 7, 2013; as the appropriate sources of service information.
However, ATR Service Bulletin ATR42-92-0025, dated November 7, 2013;
and ATR Service Bulletin ATR72-92-1034, dated November 7, 2013, only
provide corrective action if incorrect routing is found. Therefore,
operators would have to contact the FAA for corrective action if any
damage is found.
    We have re-designated paragraph (h) of the NPRM (79 FR 47390,
August 13, 2014) as paragraph (h)(1) of this AD. In paragraph (h)(1) of
this AD, we specify modifying the bonding lead routing if any incorrect
routing is found, in accordance with ATR Service Bulletin ATR42-92-
0025, dated November 7, 2013; or ATR Service Bulletin ATR72-92-1034,
dated November 7, 2013. We have also added paragraph (h)(2) to this AD
to specify doing a repair if any damage is found, in accordance with a
method approved by the Manager, International Branch, ANM-116,
Transport Airplane Directorate, FAA.

Conclusion

    We reviewed the relevant data and determined that air safety and
the public interest require adopting this AD with the change described
previously and except for minor editorial changes. We have determined
that these minor changes:
     Are consistent with the intent that was proposed in the
NPRM (79 FR 47390, August 13, 2014) for correcting the unsafe
condition; and
     Do not add any additional burden upon the public than was
already proposed in the NPRM (79 FR 47390, August 13, 2014).

Costs of Compliance

    We estimate that this AD affects 5 airplanes of U.S. registry.
    We also estimate that it will take about 2 work-hours per product
to comply with the basic requirements of this AD. The average labor
rate is $85 per work-hour. Required parts will cost about $0 per
product. Based on these figures, we estimate the cost of this AD on
U.S. operators to be $850, or $170 per product.
    In addition, we estimate that any necessary follow-on actions will
take about 2 work-hours and require parts costing $0, for a cost of
$170 per product. We have no way of determining the number of aircraft
that might need this action.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. ``Subtitle VII: Aviation
Programs,'' describes in more detail the scope of the Agency's
authority.
    We are issuing this rulemaking under the authority described in
``Subtitle VII, Part A, Subpart III, Section 44701: General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    We determined that this AD will not have federalism implications
under Executive Order 13132. This AD will not have a substantial direct
effect on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government.
    For the reasons discussed above, I certify that this AD:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979);
    3. Will not affect intrastate aviation in Alaska; and
    4. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov/#!docketDetail;D=FAA-2014-0530; or in person at the
Docket Management Facility between 9 a.m. and 5 p.m., Monday through
Friday, except Federal holidays. The AD docket contains this AD, the
regulatory evaluation, any comments received, and other information.
The street address for the Docket Operations office (telephone 800-647-
5527) is in the ADDRESSES section.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

Adoption of the Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority:  49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive (AD):

2014-26-06 ATR--GIE Avions de Transport R[eacute]gional: Amendment
39-18057. Docket No. FAA-2014-0530; Directorate Identifier 2014-NM-
062-AD.

(a) Effective Date

    This AD becomes effective February 25, 2015.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to ATR--GIE Avions de Transport R[eacute]gional
airplanes, certificated in any category, as identified in paragraph
(c)(1) and (c)(2) of this AD.
    (1) Model ATR42-500 airplanes, manufacturer serial numbers 669
through 1005 inclusive.
    (2) Model ATR72-212A airplanes, manufacturer serial numbers 773,
774, 776 through 1094 inclusive, 1096 through 1099 inclusive, and
1101.

(d) Subject

    Air Transport Association (ATA) of America Code 92, Electrical
Routing.

(e) Reason

    This AD was prompted by a report that, during an inspection of
an airplane on the production line, interference was detected
between the electrical harness and a bonding lead due to an
incorrect installation of the affected bonding lead. We are issuing
this AD to detect and correct installation of the bonding lead,
which could cause arcing and chafing, and could possibly result in
an uncontrolled fire.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Inspection

    Within 1,000 flight hours after the effective date of this AD:
Do a detailed inspection of the bonding lead routing above the 120VU
shelf for damage (i.e., wire chafing, evidence of burning) or
incorrect routing, in accordance with the Accomplishment
Instructions of ATR Service Bulletin ATR42-92-0025, dated November
7, 2013 (for Model ATR42-500 airplanes); or ATR Service Bulletin
ATR72-92-1034, dated November 7, 2013 (for Model ATR72-212A
airplanes).

(h) Corrective Actions

    (1) If, during the inspection required by paragraph (g) of this
AD, any incorrect routing is found: Before further flight, modify
the bonding lead routing above the 120VU shelf, in accordance with
the Accomplishment Instructions of ATR Service Bulletin ATR42-92-
0025, dated November 7, 2013 (for Model ATR42-500 airplanes); or ATR
Service Bulletin ATR72-92-1034, dated November 7, 2013 (for Model
ATR72-212A airplanes).
    (2) If, during the inspection required by paragraph (g) of this
AD, any damage (i.e., wire chafing, evidence of burning) is found:
Before further flight, repair using a method approved by the
Manager, International Branch, ANM-116, Transport Airplane
Directorate, FAA.

(i) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
has the authority to approve AMOCs for this AD, if requested using
the procedures found in 14 CFR 39.19. In accordance with 14 CFR
39.19, send your request to your principal inspector or local Flight
Standards District Office, as appropriate. If sending information
directly to the International Branch, send it to ATTN: Tom
Rodriguez, Aerospace Engineer, International Branch, ANM-116,
Transport Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton,
WA 98057-3356; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>. Information
may be emailed to<EMAIL_ADDRESS>Before using any
approved AMOC, notify your appropriate principal inspector, or
lacking a principal inspector, the manager of the local flight
standards district office/certificate holding district office. The
AMOC approval letter must specifically reference this AD.
    (2) Contacting the Manufacturer: For any requirement in this AD
to obtain corrective actions from a manufacturer, the action must be
accomplished using a method approved by the Manager, International
Branch, ANM-116, Transport Airplane Directorate, FAA; or the
European Aviation Safety Agency (EASA); or ATR--GIE Avions de
Transport R[eacute]gional's EASA Design Organization Approval (DOA).
If approved by the DOA, the approval must include the DOA-authorized
signature.

(j) Related Information

    Refer to Mandatory Continuing Airworthiness Information (MCAI)
European Aviation Safety Agency Airworthiness Directive 2014-0056,
dated March 7, 2014, for related information. This MCAI may be found
in the AD docket on the Internet at http://www.regulations.gov/#!documentDetail;D=FAA-2014-0530-0002.

(k) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless this AD specifies otherwise.
    (i) ATR Service Bulletin ATR42-92-0025, dated November 7, 2013.
    (ii) ATR Service Bulletin ATR72-92-1034, dated November 7, 2013.
    (3) For service information identified in this AD, contact ATR--
GIE Avions de Transport R[eacute]gional, 1, All[eacute]e Pierre
Nadot, 31712 Blagnac Cedex, France; telephone +33 (0) 5 62 21 62 21;
fax +33 (0) 5 62 21 67 18; email<EMAIL_ADDRESS>
Internet http://www.aerochain.com.
    (4) You may view this service information at the FAA, Transport
Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For
information on the availability of this material at the FAA, call
425-227-1221.
    (5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Renton, Washington, on December 19, 2014.
Michael Kaszycki,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2014-30914 Filed 1-20-15; 8:45 am]
BILLING CODE 4910-13-P


Glossary
Abbreviations and Symbols
The following abbreviations and symbols are used with Statistics of U.S. Businesses (SUSB) data:
D
Withheld to avoid disclosing data for individual companies; data are included in higher level totals
G
Low noise; cell value was changed by less than 2 percent by the application of noise
H
Moderate noise; cell value was changed by 2 percent or more but less than 5 percent by the application of noise
J
High noise; cell value was changed by 5 percent or more by the application of noise
S
Withheld because estimate did not meet publication standards
N
Not available or not comparable
r
Revised
a
0 to 19 employees
b
20 to 99 employees
c
100 to 249 employees
e
250 to 499 employees
f
500 to 999 employees
g
1,000 to 2,499 employees
h
2,500 to 4,999 employees
i
5,000 to 9,999 employees
j
10,000 to 24,999 employees
k
25,000 to 49,999 employees
l
50,000 to 99,999 employees
m
100,000 employees or more
Business Information Tracking Series (BITS)
A file which links establishments in the annual County Business Patterns data from year to year. We use a series of matches to link establishments across years. The primary match links establishments having the same census identification number in both the initial and subsequent years. These are establishments which have undergone no ownership or organizational changes.
The remainder of the matches uses establishment identification numbers such as the employer identification number, as well as establishment attributes like business name and address, ZIP code, and industry code to create links for establishments that have remained in existence but have undergone ownership or organizational changes which lead to changes in the census identification numbers across years.
Using this file, we are able to create longitudinal tabulations. A longitudinal tabulation is a tabulation that provides a study of business entities across a span of years. A longitudinal tabulation measures the change in business entities, such as establishment births, deaths, expansions, and contractions for an industry and/or enterprise size. In contrast, non-longitudinal tabulations show aggregate totals for an industry and/or enterprise size. Comparison of non-longitudinal tabulations of two-year time periods do not provide explanations for changes in business entities.
Congressional District
A congressional district is an electoral constituency that elects a single member of a congress. A congressional district is based on population, which, in the United States, is taken using a census every ten years. There are 435 congressional districts in the United States House of Representatives.
Employment
Paid employment consists of full- and part-time employees, including salaried officers and executives of corporations, who are on the payroll in the pay period including March 12. Included are employees on paid sick leave, holidays, and vacations; not included are sole proprietors and partners of unincorporated businesses.
Enterprise
An enterprise (or "company") is a business organization consisting of one or more domestic establishments that were specified under common ownership or control. The enterprise and the establishment are the same for single-establishment firms. Each multi-establishment company forms one enterprise - the enterprise employment and annual payroll are summed from the associated establishments.
Enterprise Classification
An enterprise may have establishments in many different industries. For the purpose of classifying an entire enterprise into a single industry, the classification methodology starts by excluding nonoperating establishments - establishments classified as manufacturers' sales branches and offices, establishments engaged in management of companies and enterprises (NAICS 55), and auxiliary establishments. The enterprise is then classified into the 2-digit NAICS sector in which it paid the largest share of its payroll. Then, within this 2-digit NAICS sector, the enterprise is classified into the 3-digit NAICS sub-sector in which the enterprise paid the largest share of payroll. Finally, within the assigned 3-digit NAICS sub-sector, the enterprise is classified into the 4-digit NAICS industry group with the largest share of payroll.
SUSB currently has tabulations by Enterprise Industry for the 2012-2015 reference years.
Enterprise Size
Enterprise size designations are determined by the summed employment of all associated establishments. Employer enterprises with zero employees are enterprises for which no associated establishments reported paid employees in the mid-March pay period but paid employees at some time during the year.
Establishment
An establishment is a single physical location at which business is conducted or services or industrial operations are performed. It is not necessarily identical with a company or enterprise, which may consist of one or more establishments. When two or more activities are carried on at a single location under a single ownership, all activities generally are grouped together as a single establishment. The entire establishment is classified on the basis of its major activity and all data are included in that classification.
Establishment counts represent the number of locations with paid employees any time during the year. This series excludes government establishments except for wholesale liquor establishments (NAICS 4248), retail liquor stores (NAICS 44531), tobacco stores (NAICS 453991), book publishers (511130), monetary authorities  -  central bank (NAICS 521110), federally-chartered savings institutions (NAICS 522120), federally-chartered credit unions (NAICS 522130), hospitals (NAICS 622), gambling industries (NAICS 7132), and casino hotels (NAICS 721120).
Establishment Births
Births are establishments that have zero employment in the first quarter of the initial year and positive employment in the first quarter of the subsequent year.
Establishment Contractions
Contractions are establishments that have positive first quarter employment in both the initial and subsequent years and decrease employment during the time period between the first quarter of the initial year and the first quarter of the subsequent year.
Establishment Deaths
Deaths are establishments that have positive employment in the first quarter of the initial year and zero employment in the first quarter of the subsequent year.
Establishment Expansions
Expansions are establishments that have positive first quarter employment in both the initial and subsequent years and increase employment during the time period between the first quarter of the initial year and the first quarter of the subsequent year.
Firm
A firm is a business organization consisting of one or more domestic establishments in the same geographic area and industry that were specified under common ownership or control. The firm and the establishment are the same for single-establishment firms. For each multi-establishment firm, establishments in the same industry within a geographic area will be counted as one firm; the firm employment and annual payroll are summed from the associated establishments.
Legal Form of Organization (LFO)
LFO is assigned at the establishment level and is derived from administrative records data sources. The following LFOs are included in this report.
C-Corporation and other corporate legal forms of organization - An incorporated business that is granted a charter recognizing it as a separate legal entity having its own privileges, and liabilities distinct from those of its members.
S-Corporation - A form of corporation where the entity does not pay any federal income taxes. The corporation's income or losses are divided among and passed to its shareholders. The shareholders must then report the income or loss on their own individual income tax returns.
Sole Proprietorships - An unincorporated business with a sole owner.
Partnership - An unincorporated business where two or more persons join to carry on a trade or business with each having a shared financial interest in the business.
Non-profit - An organization that does not distribute surplus funds to its owners or shareholders, but instead uses surplus funds to help pursue its goals. Most non-profit organizations are exempt from income taxes.
Government - A business that taxpayers primarily fund. Most government businesses are out of scope to this data series.
Metropolitan/Micropolitan Statistical Area (MSA)
MSA is a core area containing a substantial population nucleus, together with adjacent communities having a high degree of economic and social integration with that core.
Each metropolitan statistical area must have at least one urbanized area of 50,000 or more inhabitants. Each micropolitan statistical area must have at least one urban cluster of at least 10,000 but less than 50,000 population.  Metropolitan and micropolitan statistical areas can be collectively referred to as "Core Based Statistical Areas" (CBSAs); however, SUSB uses the term MSA.
Noise Infusion
Noise infusion is a method of disclosure avoidance in which a random noise multiplier is applied to certain data values for each business prior to table creation. Disclosure protection is accomplished in a manner that results in a relatively small change in the majority of tabulated values.
North American Industry Classification System (NAICS)
The North American Industry Classification System (NAICS) is the standard used by Federal statistical agencies in classifying business establishments for the purpose of collecting, analyzing, and publishing statistical data related to the U.S. business economy. This system is used by the United States, Canada and Mexico.
Payroll
Payroll includes all forms of compensation, such as salaries, wages, commissions, dismissal pay, bonuses, vacation allowances, sick-leave pay, and employee contributions to qualified pension plans paid during the year to all employees. For corporations, payroll includes amounts paid to officers and executives; for unincorporated businesses, it does not include profit or other compensation of proprietors or partners. Payroll is reported before deductions for social security, income tax, insurance, union dues, etc. This definition of payroll is the same as that used by the Internal Revenue Service (IRS) on Form 941 as taxable Medicare Wages and Tips (even if not subject to income or FICA tax). First-quarter payroll consists of payroll during the January-to-March quarter.
Receipts
Receipts (net of taxes collected from customers or clients) are defined as operating revenue for goods produced or distributed, or for services provided. Receipts excludes local, state, and federal sales and other taxes collected from customers or clients and paid directly to a tax agency. Receipts are acquired from economic census data for establishments in industries that are in-scope to the economic census; receipts are acquired from IRS tax data for single-establishment businesses in industries that are out-of-scope to the economic census; and payroll-to-receipts ratios are used to estimate receipts for multi-establishment businesses in industries that are out-of-scope to the economic census. SUSB tabulations provide summed establishment receipts which creates some duplication of receipts for large multi-establishment enterprises. Receipts data are available for years ending in 2 and 7 only.
Statewide
A county-equivalent geography assigned to employers without a fixed location within a state (or of unknown county location). Employers who report data for multiple locations under one common location are also given a statewide classification. This incomplete detail causes only slight understatement of county employment.