[Federal Register Volume 76, Number 235 (Wednesday, December 7, 2011)]
[Notices]
[Pages 76424-76429]
[FR Doc No: 2011-31499]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0326]

Biologics Price Competition and Innovation Act of 2009; Proposed
Recommendations for a User Fee Program for Biosimilar and
Interchangeable Biological Product Applications for Fiscal Years 2013
Through 2017; Notice of Public Meeting; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comments.

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SUMMARY: The Food and Drug Administration (FDA) is announcing a public
meeting to discuss the proposed recommendations for a user fee program
for biosimilar biological products for fiscal years (FYs) 2013 through
2017.

DATES: The public meeting will be held on Friday, December 16, 2011,
from 9 a.m. to 1 p.m. Registration to attend the meeting must be
received by December 14, 2011. See section III.B of this document for
information on how to register for the meeting. Submit either
electronic or written comments by January 6, 2012.

ADDRESSES: The public meeting will be held at FDA's White Oak Campus,
10903 New Hampshire Ave., Bldg. 31, Rm. 1503, Silver Spring, MD, 20993-
0002. Please note that visitors to the White Oak Campus must enter
through Building 1.
    Submit electronic comments to http://www.regulations.gov. Submit
written comments to the Division of Dockets Management (HFA-305), Food
and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD
20852. All comments should be identified with the docket number found
in brackets in the heading of this document.
    Transcripts of the meeting will be available for review at the
Division of Dockets Management and on the Internet at http://www.regulations.gov approximately 30 days after the public meeting (see
section III.C of this document).

FOR FURTHER INFORMATION CONTACT:  Rokhsana Safaai-Jazi, Food and Drug
Administration, Center for Drug Evaluation and Research, 10903 New
Hampshire Ave., Bldg. 51, Rm. 1164, Silver Spring, MD 20993-0002, (301)
796-4463, Fax:<PHONE_NUMBER>, Email:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Introduction

    FDA is announcing a public meeting to discuss proposed
recommendations for a user fee program for biosimilar biological
products (biosimilars user fee program) for FYs 2013 through 2017. On
March 23, 2010, President Obama signed into law the Affordable Care Act
(Pub. L. 111-148). The Affordable Care Act contains a subtitle called
the Biologics Price Competition and Innovation Act of 2009 (BPCI Act)
that amends the Public Health Service Act (PHS Act) and other statutes
to create an abbreviated approval pathway for biological products shown
to be biosimilar to or interchangeable with an FDA-licensed reference
biological product. (See sections 7001 through 7003 of the Affordable
Care Act.) Section 351(k) of the PHS Act (42 U.S.C. 262(k)), added by
the BPCI Act, allows a company to submit an application for licensure
of a biosimilar or interchangeable biological product.
    The BPCI Act also amends section 735 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 379g) to include 351(k) applications in the
definition of ``human drug application'' for the purposes of the
prescription drug user fee provisions. (See section 7002(f)(3)(A) of
the Affordable Care Act.) Accordingly, under section 736 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 379h), the fee for a biologics
license application (BLA) is currently the same regardless of whether
the application is submitted under the new 351(k) approval pathway or
the preexisting 351(a) approval pathway.
    The authority conferred by the Federal Food, Drug, and Cosmetic
Act's prescription drug user fee provisions expires in September 2012.
The BPCI Act directs FDA to develop recommendations for a biosimilars
user fee program for FYs 2013 through 2017. (See section 7002(f)(1) of
the Affordable Care Act.) The BPCI Act provides that FDA must consult
with a range of groups, including scientific and academic experts,
health care professionals, representatives of patient and consumer
advocacy groups (public stakeholders), and regulated industry (industry
stakeholders), in developing the recommendations. As described in
section II of this document, FDA consulted with public and industry
stakeholders from June 2011 through September 2011.
    The BPCI Act requires that FDA must publish the recommendations for
a biosimilars user fee program in the Federal Register and provide a
period of 30 days for the public to provide written comments on the
recommendations.

FDA is also required to hold a meeting at which the public may present
its views on such recommendations. After consideration of such public
views and comments, FDA is to revise the recommendations as necessary
and transmit them to Congress by January 15, 2012.
    This notice, the 30-day comment period, and the public meeting will
satisfy certain of these requirements. After the public meeting, FDA
will revise the recommendations as necessary and present them to
Congress. (See section 7002(f)(1) of the Affordable Care Act.)
Additional information is provided in this document to help potential
meeting participants better understand the proposed recommendations.

II. Proposed Biosimilars User Fee Program Recommendations

    In developing proposed recommendations for a biosimilars user fee
program, FDA has conducted discussions with regulated industry and
consulted with public stakeholders, as required by the law. FDA
initiated the public consultation process on November 2 and 3, 2010, by
holding a public hearing at which stakeholders and other members of the
public were given an opportunity to present their views on issues
associated with the implementation of the BPCI Act. (See 75 FR 61497,
October 5, 2010.) \1\ Among other issues relating to the implementation
of the BPCI Act, FDA solicited public comment on the following
questions related to a biosimilars user fee program:
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    \1\ http://edocket.access.gpo.gov/2010/pdf/2010-24853.pdf.
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     If the existing fee structure under the Prescription Drug
User Fee Act (PDUFA) were to be considered as a model in establishing a
user fee structure for applications and supplements for proposed
biosimilar and interchangeable biological products, what factors and
changes should FDA take into consideration, and why?
     What factors should FDA take into account when considering
whether to recommend that user fees for biosimilar and interchangeable
biological products should also be used to monitor safety after
approval?
    In the Federal Register of May 10, 2011 (76 FR 27062),\2\ FDA
published a notice requesting public input on FDA's proposed principles
for development of a biosimilars user fee program, FDA's proposed
structure for a biosimilars user fee program that would adhere to these
principles, and proposed performance goals for this program.
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    \2\ http://www.gpo.gov/fdsys/pkg/FR-2011-05-10/pdf/2011-11348.pdf.
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    From June 2011 through September 2011, FDA conducted negotiations
with regulated industry, and consultation meetings with public
stakeholders, concerning development of recommendations for a
biosimilars user fee program. FDA posted minutes of these meetings on
its Web site at http://www.fda.gov/ForIndustry/UserFees/ucm268124.htm.
    The proposed biosimilars user fee program for FYs 2013 through 2017
addresses many of the top priorities identified by public and industry
stakeholders, and the most important challenges identified within FDA.
The proposed biosimilars user fee program is similar to the PDUFA
program in that it includes fees for marketing applications,
manufacturing establishments, and products. However, there are some
differences because of the nascent state of the biosimilars industry in
the United States. For example, there are no currently marketed
biosimilar biological products; accordingly, the recommended
biosimilars user fee program includes fees for products in the
development phase in order to generate fee revenue in the near-term and
to enable sponsors to have meetings with FDA early in the development
of biosimilar biological product candidates.
    As in all of FDA's other medical product user fee programs, under
the proposed biosimilars user fee program, user fee funding would
supplement dedicated non-user fee funding to ensure sufficient
resources for the Agency's biosimilars review program. In each fiscal
year, in order to spend biosimilars user fees, FDA would be required to
have available and allocate at least $20 million, adjusted for
inflation, in non-user fee money for biosimilars review activities.
    Under the proposed biosimilars user fee program, FDA would be
authorized to spend biosimilars user fees on Agency activities related
to the review of submissions in connection with biosimilar biological
product development, biosimilar biological product applications, and
supplements. This would include activities related to biosimilar
biological product development meetings and investigational new drug
applications (INDs). It would also include development of the
scientific, regulatory, and policy infrastructure necessary for review
of biosimilar biological product applications, such as regulation and
policy development related to the review of biosimilar biological
product applications, and development of standards for products subject
to review and evaluation. It would cover FDA activities at the
application stage, such as review of advertising and labeling prior to
approval of a biosimilar biological product application or supplement;
review of required postmarketing studies and postmarketing studies that
have been agreed to by sponsors as a condition of approval; the
issuance of action letters that communicate decisions on biosimilar
biological product applications; and inspection of biosimilar
biological product establishments and other facilities undertaken as
part of FDA's review of pending biosimilar biological product
applications and supplements (but not inspections unrelated to the
review of biosimilar biological product applications and supplements).
Finally, it would include some activities at the post-approval stage,
such as postmarketing safety activities with respect to biologics
approved under biosimilar biological product applications or
supplements.

A. Proposed Fees

    The four types of fees under the proposed biosimilars user fee
program are summarized in this section II.A.
1. Biosimilar Product Development Fees
    FDA's proposed biosimilars user fee program includes initial and
annual biosimilar product development (BPD) fees for biosimilar
biological products in development. The initial BPD fee would be due
upon the date of submission of an IND describing an investigation that
FDA determines is intended to support a biosimilar biological
application for a product, or within 5 days after FDA grants a request
for a ``biosimilar biological product development meeting'' (BPD
Meeting) for a product. (BPD Meetings are further described in section
II.B.7 of this document.)
    Additionally, under the proposed BPD program, if FDA determines
that an IND is intended to support a biosimilar biological product
application for a product, each person that has submitted an IND before
the date of enactment of the legislation authorizing the biosimilars
user fee program would also be subject to the initial BPD fee. A
sponsor would be assessed only one initial BPD fee per product.
Regardless of the number of proposed indications for the biosimilar
biological product, the sponsor would pay one BPD fee per product. The
initial BPD fee for each of the FYs 2013 through 2017 would be equal to
10 percent of the fee established for a human drug

application under PDUFA for that fiscal year.
    Beginning in the next fiscal year after a sponsor has paid the
initial BPD fee for a product, the sponsor would pay an annual BPD fee
on or before October 1 of each year, until the sponsor submits a
marketing application for the product that is accepted for filing, or
discontinues participation in the BPD program for the product. A
sponsor that has not submitted an IND for the product may discontinue
participation in the BPD program by submitting a written declaration to
FDA affirming that the sponsor has no present intention of further
developing the product as a biosimilar biological product. A sponsor
that has submitted an IND for the product would be able to effectuate
the discontinuation only after withdrawing the IND as specified in 21
CFR part 312. A sponsor must discontinue participation in the BPD
program by August 1 of the year of discontinuation to avoid incurring
the fee that otherwise would be due on October 1. A sponsor that
maintains an IND for the product after submitting a marketing
application for the product that was accepted for filing would not pay
the annual BPD fee for that product.
    A sponsor that has discontinued participation in the BPD program
for a product would be required to pay a reactivation fee in order to
resume participation in the BPD program for that product. The
reactivation fee would be equal to twice the initial BPD fee for that
fiscal year. The reactivation fee would be due within 5 days after FDA
grants a request for a BPD Meeting for the product, or upon the date of
submission of an IND describing an investigation that FDA determines is
intended to support a biosimilar biological product application for
that product, whichever is earlier. A sponsor that pays a reactivation
fee for a product would be required to pay the annual BPD fee for the
product beginning in the next fiscal year.
    If a sponsor has failed to pay the initial BPD fee, annual BPD fee,
or reactivation fee as required, FDA would not provide a BPD Meeting
relating to the biosimilar biological product for which the fees are
owed. Also, except in extraordinary circumstances, if a sponsor that
owes BPD fees submits an IND that FDA determines is intended to support
a biosimilar biological product application, FDA would not consider the
sponsor's IND to have been received under section 505(i)(2) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)(2)). In
addition, if a sponsor that owes BPD fees has an existing IND that FDA
determines is intended to support a biosimilar biological product
application, FDA would prohibit the sponsor from continuing the
investigation (this action would be referred to as ``financial hold'').
Finally, if a sponsor has failed to pay BPD fees as required, then any
biosimilar biological product application or supplement submitted by
that sponsor would be considered incomplete and would not be accepted
for filing until all fees owed by the sponsor have been paid.
2. Marketing Application Fee
    FDA estimates that the cost of reviewing an application for
licensure of a biosimilar biological product will be comparable to the
cost of reviewing an application for licensure of a biological product
under section 351(a) of the PHS Act. FDA therefore proposes to set the
marketing application fee for a biosimilar biological product equal to
the fee established for a human drug application under PDUFA, minus the
cumulative amount of any BPD fees (including any reactivation fees)
paid for the product that is the subject of the application. The
feedback and consultation that FDA expects to provide to sponsors
during the biosimilar biological product development phase is expected
to improve the efficiency of the biosimilar biological product
development process and the quality of submitted marketing
applications. Therefore, FDA considers the BPD phase fees, and the
deduction of paid BPD fees from the associated marketing application
fee payment, to be a reasonable approach to shift resources forward to
the point in development where FDA review is currently being sought by
sponsors.
3. Establishment Fees and Product Fees
    Because the complexity and level of effort required for FDA
oversight of manufacturing and postmarketing safety issues for products
licensed under section 351(k) of the PHS Act is expected to be
comparable to that required for products licensed under section 351(a),
FDA proposes setting biosimilar biological product establishment and
product fees equal to the establishment and product fees under PDUFA
for any fiscal year. FDA anticipates a modest level of funding from
these sources initially because only biosimilar biological products
that are approved for marketing would be subject to these fees.

B. Proposed Performance Goals and Procedures

    The full description of the proposed performance goals and
procedures for the biosimilars user fee program can be found in the
draft biosimilars user fee commitment letter (draft commitment letter)
posted on FDA's Web site at http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/UCM281991.pdf. The proposed performance goals and procedures are
described in this section II.B with reference to the section of the
draft commitment letter where more detailed information can be found.
1. Review Performance Goals
    The proposed biosimilars review program would include review
performance goals for biosimilar biological product application
submissions and resubmissions, supplements with clinical data, and
original manufacturing supplements. Further information concerning
these review performance goals can be found in section I of the draft
commitment letter. The review performance goals are summarized in
tables 1 and 2 of this document.:

              Table 1--Performance Goals for Original and Resubmitted Applications and Supplements
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                                                                 Performance goal
        Submission cohort        -------------------------------------------------------------------------------
                                      FY 2013         FY 2014         FY 2015         FY 2016         FY 2017
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                                      Within 10 Months of the Receipt Date
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Original Biosimilar Biological               70%             70%             80%             85%             90%
 Product Application Submissions
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                                       Within 6 Months of the Receipt Date
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Resubmitted Original Biosimilar              70%             70%             80%             85%             90%
 Biological Product Applications
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                       Table 2--Performance Goals for Original and Resubmitted Supplements
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               Submission                                            Performance goal
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Original Supplements with Clinical Data  90% Within 10 Months of the Receipt Date.
Resubmitted Supplements with Clinical    90% Within 6 Months of the Receipt Date.
 Data.
Manufacturing Supplements..............  90% Within 6 Months of the Receipt Date.
----------------------------------------------------------------------------------------------------------------

2. First Cycle Performance Goals
    The proposed biosimilars review program includes first cycle review
performance goals for original biosimilar biological product
applications and supplements with clinical data. For 90 percent of
applications and supplements with clinical data, FDA's goal would be to
inform the applicant of any substantive review issues identified during
the initial filing review within 74 calendar days of the receipt date.
In addition, for 90 percent of applications and supplements with
clinical data, FDA's goal would be to inform the applicant of the
planned review timeline for the application within 74 calendar days of
the receipt date. Section II of the draft commitment letter contains
further information concerning these performance goals.
3. Review of Proprietary Names To Reduce Medication Errors
    The proposed biosimilars review program includes proprietary name
review performance goals. For proprietary names submitted during the
biosimilar biological product development phase, FDA's goal would be to
review 90 percent within 180 days of receipt. For proprietary names
submitted with the biosimilar biological product application, FDA's
goal would be to review 90 percent within 90 days of receipt. Section
III of the draft commitment letter contains further information
concerning these performance goals.
4. Major Dispute Resolution
    The proposed biosimilars review program includes a major dispute
resolution performance goal. For procedural or scientific matters
involving the review of biosimilar biological product applications and
supplements that cannot be resolved at the signatory authority level,
FDA's goal would be to respond to 90 percent of decision appeals within
30 calendar days of FDA's receipt of the written appeal, provided that
certain conditions are met. Section IV of the draft commitment letter
contains further information concerning this performance goal.
5. Clinical Holds
    The proposed biosimilars review program includes a clinical hold
performance goal. FDA's goal would be to respond to 90 percent of
sponsors' complete responses to a clinical hold within 30 days of FDA's
receipt of the complete response submission. Section V of the draft
commitment letter contains further information concerning this
performance goal.
6. Special Protocol Assessment
    The proposed biosimilars review program includes procedures and
performance goals for special protocol assessments. Under the proposed
program, provided that certain conditions are met, upon specific
request by a sponsor, the Agency would evaluate certain protocols and
related issues to assess whether the design is adequate to meet
scientific and regulatory requirements identified by the sponsor. FDA's
goal would be to provide a written response to the sponsor that
includes a succinct assessment of the protocol and answers to the
questions posed by the sponsor. For FYs 2013 and 2014, FDA's goal would
be to respond to 70 percent of the requests within 45 days of FDA's
receipt of the protocol and specific questions. For FY 2015, FDA's goal
would be to respond to 80 percent of the requests within the 45-day
time frame; for FY 2016, 85 percent, and for FY 2017, 90 percent.
Section VI of the draft commitment letter contains further information
concerning this performance goal.
7. Meeting Management Goals
    FDA proposes performance goals and procedures regarding meetings
related to sponsors' biosimilar biological product development
programs. Further information concerning these goals can be found in
section VII of the draft commitment letter. These goals and procedures
would apply to Biosimilar Initial Advisory Meetings and BPD Meetings.
Under the proposed program, a Biosimilar Initial Advisory Meeting is an
initial assessment limited to a general discussion regarding whether
licensure under section 351(k) of the PHS Act may be feasible for a
particular product, and, if so, general advice on the expected content
of the development program. It does not include any meeting that
involves substantive review of summary data or full study reports. A
BPD Meeting is any meeting, other than a Biosimilar Initial Advisory
Meeting, regarding the content of a development program, including a
proposed design for, or data from, a study intended to support a
biosimilar biological product application. The four types of BPD
Meetings are as follows:
     A BPD Type 1 Meeting is a meeting that is necessary for an
otherwise stalled drug development program to proceed (e.g., meeting to
discuss clinical holds, dispute resolution meeting), a special protocol
assessment meeting, or a meeting to address an important safety issue.
     A BPD Type 2 Meeting is a meeting to discuss a specific
issue (e.g., proposed study design or endpoints) or questions where FDA
will provide targeted advice regarding an ongoing biosimilar biological
product development program. BPD Type 2 Meetings include substantive
review of

summary data, but does not include review of full study reports.
     A BPD Type 3 Meeting is an in-depth data review and advice
meeting regarding an ongoing biosimilar biological product development
program. This type of meeting includes substantive review of full study
reports, FDA advice regarding the similarity between the proposed
biosimilar biological product and the reference product, and FDA advice
regarding additional studies, including design and analysis.
     A BPD Type 4 Meeting is a meeting to discuss the format
and content of a biosimilar biological product application or
supplement submitted under section 351(k) of the PHS Act.
    The proposed review program includes performance goals for
responses to meeting requests. Specifically, for 90 percent of BPD Type
1 Meeting requests, FDA's goal would be to notify the requester in
writing of the date, time, place, and format for the meeting, as well
as expected Center participants, within 14 calendar days of FDA's
receipt of the request and meeting package. For 90 percent of BPD Type
2, 3, and 4 Meeting requests and Biosimilar Initial Advisory Meeting
requests, FDA's goal would be to notify the requester in writing of the
date, time, place, and format for the meeting, as well as expected
Center participants, within 21 calendar days of FDA's receipt of the
request and meeting package.
    The proposed review program also includes performance goals for
scheduling meetings within target time frames. The target time frames
for each of the five meeting types are as follows:

              Table 3--Target Time Frames for Meeting Types
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                                   Timeframe after receipt of meeting
         Meeting type                 request and meeting package
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Biosimilar Initial Advisory    Meeting should occur within 90 calendar
 Meeting.                       days of FDA receipt.
BPD Type 1 Meeting...........  Meeting should occur within 30 calendar
                                days of FDA receipt.
BPD Type 2 Meeting...........  Meeting should occur within 75 calendar
                                days of FDA receipt.
BPD Type 3 Meeting...........  Meeting should occur within 120 calendar
                                days of FDA receipt.
BPD Type 4 Meeting...........  Meeting should occur within 60 calendar
                                days of FDA receipt.
------------------------------------------------------------------------

    The performance goals for each meeting type are as follows:
     For FY 2013, 70 percent of Biosimilar Initial Advisory
Meetings and BPD Type 1, 2, 3, and 4 Meetings are held within the
target time frame.
     For FY 2014, 70 percent of Biosimilar Initial Advisory
Meetings and BPD Type 1, 2, 3, and 4 Meetings are held within the
target time frame.
     For FY 2015, 80 percent of Biosimilar Initial Advisory
Meetings and BPD Type 1, 2, 3, and 4 Meetings are held within the
target time frame.
     For FY 2016, 85 percent of Biosimilar Initial Advisory
Meetings and BPD Type 1, 2, 3, and 4 Meetings are held within the
target time frame.
     For FY 2017, 90 percent of Biosimilar Initial Advisory
Meetings and BPD Type 1, 2, 3, and 4 Meetings are held within the
target time frame.
    Under the proposed program, in order for a meeting to qualify for
these performance goals, certain conditions would need to be met.
First, the meeting request and meeting package must include the
information outlined in the draft commitment letter. Second, FDA must
concur that the meeting will serve a useful purpose (i.e., it is not
premature or clearly unnecessary). If FDA determines that a different
type of meeting is more appropriate, it may grant a meeting of a
different type than requested, which may require the payment of a BPD
fee before the meeting will be provided. If a BPD fee is required and
the sponsor does not pay the fee within the required time frame, the
meeting will be cancelled. If the sponsor pays the BPD fee after the
meeting has been cancelled because of non-payment, the target time
frame for the meeting will be calculated from the date on which FDA
received the payment, not the date on which the sponsor originally
submitted the meeting request.
    FDA's goal would be to provide meeting minutes within 30 days of
the date of the meeting for 90 percent of Biosimilar Initial Advisory
Meetings and BPD Type 1, 2, 3, and 4 Meetings. Finally, FDA's goal
would be to develop and publish for comment draft guidance on
Biosimilar Initial Advisory Meetings and BPD Type 1, 2, 3, and 4
Meetings by the end of the second quarter of FY 2014.

III. What information should you know about the public meeting?

A. When and where will the public meeting occur? What format will FDA
use?

    We will convene a public meeting to hear the public's views on the
proposed recommendations for a biosimilars user fee program. We will
conduct the meeting on December 16, 2011, at FDA's White Oak Campus
(see ADDRESSES). The meeting will include a presentation by FDA and a
series of panels representing different stakeholder groups identified
in the statute (such as patient advocacy groups, consumer advocacy
groups, health professionals, and regulated industry) to provide input
on the proposed recommendations. We will also provide an opportunity
for other organizations and individuals to make presentations at the
meeting or to submit written comments to the docket before the meeting.

B. How do you register for the public meeting or submit comments?

    If you wish to attend this meeting, please register by email at:
<EMAIL_ADDRESS>by December 14, 2011. Your email
should contain complete contact information for each attendee,
including: Name title, affiliation, address, email, address, and phone
number. Registration is free and will be on a first-come, first-served
basis. Early registration is recommended because seating is limited.
FDA may limit the number of participants from each organization based
on space limitations. Registrants will receive confirmation once they
have been accepted. On-site registration on the day of the meeting will
be based on space availability. We will try to accommodate all persons
who wish to make a presentation. If you need special accommodations
because of disability, please notify FDA by email to
<EMAIL_ADDRESS>or Rokhsana Safaai-Jazi (see FOR
FURTHER INFORMATION CONTACT) at least 4 days before the meeting.
    In addition, interested persons may submit to the Division of
Dockets Management (see ADDRESSES) either electronic or written
comments regarding this document. It is only necessary to send one set
of comments. It is no longer necessary to send two copies of mailed
comments. Identify comments with the docket number found in brackets in
the heading of this document. Received comments may be

seen in the Division of Dockets Management between 9 a.m. and 4 p.m.,
Monday through Friday. To ensure consideration, all comments must be
received by January 6, 2012.

C. Will meeting transcripts be available?

    As soon as a transcript is available, it will be accessible at
http://www.regulations.gov and http://www.fda.gov. It may be viewed at
the Division of Dockets Management (see ADDRESSES). A transcript will
also be made available in either hard copy or on CD-ROM, after
submission of a Freedom of Information request. Written requests are to
be sent to Division of Freedom of Information (ELEM-1029), Food and
Drug Administration, 12420 Parklawn Dr., Element Bldg., Rockville, MD
20857.

IV. Additional Information on the BPCI Act

    The following sources of information on FDA's Web site may serve as
useful information:
     The Federal Register document that announced the November
2010 public hearing and requested public comments is available at
http://edocket.access.gpo.gov/2010/pdf/2010-24853.pdf. (FDA has
verified the Web site address, but FDA is not responsible for any
subsequent changes to the Web site after this document publishes in the
Federal Register.)
     Comments submitted in response to the November 2010 public
hearing document can be found at http://www.regulations.gov using
Docket No. FDA-2010-N-0477.
     The Federal Register notice document that requested
notification of stakeholder intention to participate in consultation
meetings in December 2010 is available at http://edocket.access.gpo.gov/2010/pdf/2010-30713.pdf.
     The Federal Register notice that requested input on the
comments relating to the development of a user fee program for
biosimilar and interchangeable biological product applications in May
2010 is available at http://www.gpo.gov/fdsys/pkg/FR-2011-05-10/pdf/2011-11348.pdf. Additional information regarding implementation of the
BPCI Act is available at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/UCM215031.

    Dated: December 5, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-31499 Filed 12-5-11; 4:15 p.m.]
BILLING CODE 4160-01-P


P-19-0059 Sanitized Support Documents Index:
 P-19-0059 Sanitized Determination Document (linked)
 P-19-0059 Sanitized CHEM Report (attached)
 P-19-0059 Sanitized ECO Report (attached)
 P-19-0059 Sanitized ENG Report (attached)
 P-19-0059 Sanitized EXP Report (attached)
 P-19-0059 Sanitized Fate Report (attached)
 P-19-0059 Sanitized HLTH Report_POST-FOCUS FINAL (attached)


[Federal Register: October 8, 2008 (Volume 73, Number 196)]
[Notices]
[Page 59019-59021]
[DOCID:fr08oc08-116]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-58706; File No. SR-NYSE-2008-70]

Self-Regulatory Organizations; New York Stock Exchange LLC; Order
Granting Approval of Proposed Rule Change Amending Rules Governing
Membership in Order To Waive-In Members in Good Standing of the
American Stock Exchange LLC as Members and Member Organizations of the
Exchange

October 1, 2008.

I. Introduction

    On July 30, 2008, the New York Stock Exchange LLC (``NYSE'' or
``Exchange'') filed with the Securities and Exchange Commission
(``Commission''), pursuant to Section 19(b)(1) of the Securities
Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4 thereunder,\2\ a
proposed rule change amending its rules governing membership in order
to permit members in good standing of the American Stock Exchange LLC
(``Amex'') to waive-in to NYSE after the acquisition of Amex by NYSE
Euronext. The proposed rule change was published for comment in the
Federal Register on August 11, 2008.\3\ The Commission received no
comments on the proposal. This order approves the proposed rule change.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(l).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 58290 (August 1,
2008), 73 FR 46676 (August 11, 2008) (SR-NYSE-2008-70).
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II. Description of the Proposal

    As described in a separate proposed rule change,\4\ on January 17,
2008, the Amex Membership Corporation and NYSE Euronext entered into an
Agreement and Plan of Merger whereby, through a series of mergers
(``Mergers''), NYSE Euronext will acquire Amex, and, as a result of
these mergers, Amex will become a wholly-owned subsidiary of NYSE Group
and be renamed NYSE Alternext US LLC. Immediately following the closing
of the Mergers, those persons and entities who were authorized to trade
on Amex before the closing of the Mergers will be deemed to have
satisfied applicable qualification requirements necessary to trade on
NYSE Alternext and will be issued trading permits (referred to as ``86
Trinity Permits'') which will allow them to continue to trade on NYSE
Alternext's systems and facilities at 86 Trinity Place, New York, New
York (``86 Trinity Trading Systems'').
---------------------------------------------------------------------------

    \4\ See Securities Exchange Act Release No. 58284 (August 1,
2008), 73 FR 46086 (August 7, 2008) (SR-Amex-2008-62) (``Acquisition
Proposal'').
---------------------------------------------------------------------------

    Subsequently, NYSE Euronext intends to relocate all equities
trading previously conducted on the 86 Trinity Trading Systems to 11
Wall Street, New York, New York (the ``Equities Relocation'').\5\ The
NYSE Alternext trading systems at 11 Wall Street will be operated by
NYSE on behalf of NYSE Alternext. NYSE Alternext will also adopt a
version of NYSE's rules for trading equities on NYSE Alternext after
the Equities Relocation.\6\ Holders of the 86 Trinity Permits will be
able to apply for an NYSE Alternext equities trading

license or options trading permit upon the Equities or Options
Relocation, as applicable. After the Equities Relocation, 86 Trinity
Permit holders who apply to receive an NYSE Alternext equities trading
license will also receive an NYSE Market trading license.
---------------------------------------------------------------------------

    \5\ Subsequently, NYSE Alternext will also relocate all options
trading conducted on the 86 Trinity Trading Systems to 11 Wall
Street and utilize a trading system based on the options trading
system used by NYSE Arca, Inc. (``Options Relocation,'' and,
together with the Equities Relocation, the ``Relocations'').
    \6\ See Securities Exchange Act Release No. 58265 (July 30,
2008), 73 FR 46075 (August 7, 2008) (SR-Amex-2008-63) (``NYSE
Alternext Equities filing''). In the NYSE Alternext Equities filing,
NYSE Alternext also proposed to adopt rules governing member
organizations that are closely modeled existing NYSE Rules. After
the closing of the Mergers, there may be NYSE Alternext members or
member organizations holding an 86 Trinity Permit that do not
immediately qualify for membership under the new NYSE Alternext
membership rules. Amex has proposed that any such member would
automatically retain its membership and have a six-month grace
period to meet the new membership requirements. The grace period
would commence from the date the member receives an NYSE Alternext
equities trading permit in exchange for a valid 86 Trinity Permit.
---------------------------------------------------------------------------

NYSE and NYSE Alternext Membership Rules and Proposed Changes

    NYSE Rule 2 defines the terms ``member'' and ``member
organization.'' Under NYSE Rule 2(b), a ``member organization'' means a
registered broker or dealer (unless exempt pursuant to the Act) that is
also a member of the Financial Industry Regulatory Authority, Inc.
(``FINRA'') and has been approved by the Exchange to designate an
associated natural person to effect transactions on the floor of the
Exchange. The term also includes any natural person so registered and
approved and who directly effects transactions on the floor of the
Exchange. NYSE Rule 2(a) provides that a ``member'' includes any person
associated with and designated by a member organization to effect
transactions on the floor of the Exchange.
    NYSE Rule 300 requires members and member organizations to have a
trading license in order to effect transactions on the floor of the
Exchange or through any facility thereof. Only a qualified and approved
NYSE member organization may acquire and hold a trading license. An
NYSE member organization that holds a trading license may designate an
NYSE member to effect transactions on its behalf on the floor of the
Exchange.
    The Exchange proposes to add supplementary material to NYSE Rule 2
to provide that an NYSE Alternext member organization is deemed
qualified and approved as an NYSE member organization and thus eligible
to hold an NYSE trading license. The Exchange further proposes that
Exchange membership would be automatic for any NYSE Alternext member
organization, and that such NYSE Alternext member organization would be
exempt from the Exchange's new member organization application fee. In
addition, the Exchange proposes that any natural person associated with
an NYSE Alternext member organization, who has been approved by NYSE
Alternext as a member and designated by an NYSE Alternext member
organization to effect transactions on the floor of NYSE Alternext,
would be deemed approved as an NYSE member.
    As proposed, NYSE Alternext members and member organizations and
that seek an NYSE Alternext equities trading license would be
automatically waived in as members and member organizations of NYSE.
NYSE Alternext will have the same standards for membership as NYSE;
therefore, if NYSE Alternext determines that an applicant is qualified
to be an NYSE Alternext member organization, NYSE will accept NYSE
Alternext's determination as conclusive evidence that the applicant is
eligible for NYSE membership. NYSE Alternext will certify to the
Exchange that each such transferring member met Amex's minimum
membership standards at the time that it was approved for membership
and that nothing has come to the attention of NYSE Alternext that would
disqualify that member. If that member's 86 Trinity Permit were revoked
for any reason, it would not be deemed eligible to be approved as an
NYSE member organization.
    Some NYSE Alternext members that waive into NYSE might not be fully
compliant with all NYSE membership requirements at the time of the
waive-in.\7\ NYSE has proposed to provide any such member with a six-
month grace period in which to meet the requirements of Exchange rules
governing membership. Such grace period would begin to run from the
date that the NYSE Alternext member organization transfers its equities
operations to the NYSE Alternext trading systems at 11 Wall Street. If
the member organization fails to meet all NYSE membership requirements
by the close of the grace period, NYSE would revoke its approval to
trade. NYSE would also reserve the right to commence proceedings to
terminate that member organization.
---------------------------------------------------------------------------

    \7\ The Exchange has noted that the current Amex rules governing
membership are substantially similar to Exchange rules governing
membership. However, there are some small variations in the
membership requirements. For example, NYSE requires a member
organization to submit an opinion of counsel that a member
corporation's stock is validly issued and outstanding and that the
restrictions and provisions required by the Exchange on the
transfer, issuance, conversion, and redemption of its stock have
been made legally effective. Amex does not have such a requirement.
See NYSE Rule 313.20. Accordingly, if an NYSE Alternext member
organization has not previously provided such an opinion of counsel
to Amex, it must be provided to NYSE Alternext within six months of
the member organization transferring its equities operations to the
NYSE Alternext Trading Systems pursuant to a valid 86 Trinity
Permit.
---------------------------------------------------------------------------

    In addition, the Exchange proposes to provide a temporary exemption
from the NYSE Rule 2 requirement that each member organization be a
FINRA member. This exemption would apply to any NYSE Alternext member
organization that: (1) Holds a valid 86 Trinity Permit as of the date
that the NYSE Alternext member organization transfers its equities
operations to NYSE Alternext trading systems at 11 Wall Street; (2) is
not currently a FINRA member; and (3) is eligible for FINRA's waive-in
membership process.\8\ The Exchange proposes a 60-day grace period for
any such NYSE Alternext member organization to apply for and be
approved as a FINRA member. Such grace period would run from the date
that the NYSE Alternext member organization transfers its equities
operation to NYSE Alternext trading systems at 11 Wall Street.
---------------------------------------------------------------------------

    \8\ See Securities Exchange Act Release No. 58291 (August 1,
2008), 73 FR 46661 (August 11, 2008) (SR-FINRA-2008-043).
---------------------------------------------------------------------------

    Finally, the Exchange proposes to add temporary Rule 304A.90T to
provide a similar six-month grace period so that an approved person of
a member organization, as opposed to the member organization itself,
may address any changes that that approved person would have to make in
connection with being associated with a member organization. If an
approved person who has been designated to effect transactions on the
floor of the Exchange fails to meet the relevant requirements by the
end of the grace period, such approved person would not be permitted to
effect trades on the floor until such requirements were met.

III. Discussion and Commission Findings

    The Commission has carefully reviewed the proposed rule change and
finds that it is consistent with the requirements of the Act and the
rules and regulations thereunder applicable to a national securities
exchange.\9\ In particular, the Commission finds that the proposed rule
change is consistent with Section 6(b)(5) of the Act,\10\ which, among
other things, requires that the rules of a national securities exchange
be designed to promote just and equitable principles of trade, to
foster cooperation and coordination with persons engaged in regulating
transactions in securities, to remove impediments to and perfect the
mechanism of a free and open market and a national market system, and,
in general, to protect investors and the public interest. The
Commission also finds that the proposed rule change is consistent with
Section 6(b)(8) of the Act,\11\ which requires that the rules of an
exchange not impose any burden on

competition that is not necessary or appropriate in furtherance of the
purposes of the Act.
---------------------------------------------------------------------------

    \9\ In approving this proposed rule change, the Commission has
considered the proposed rule's impact on efficiency, competition,
and capital formation. See 15 U.S.C. 78c(f).
    \10\ 15 U.S.C. 78f(b)(5).
    \11\ 15 U.S.C. 78f(b)(8).
---------------------------------------------------------------------------

    NYSE Alternext intends to adopt membership rules that are nearly
identical to those of NYSE.\12\ Thus, if a firm were to meet NYSE
Alternext's membership rules, then it also will have met NYSE's rules.
Moreover, the same staff that administer NYSE membership rules will
also administer NYSE Alternext membership rules. Therefore, the
Commission believes it is consistent with the Act for NYSE to waive in
NYSE Alternext members that have been duly admitted to NYSE Alternext
membership. Such action will eliminate regulatory duplication without
undermining compliance with applicable membership requirements.
Similarly, the Commission believes it is consistent with the Act for
NYSE to waive the new member application fee for NYSE Alternext members
that waive into NYSE.
---------------------------------------------------------------------------

    \12\ See NYSE Alternext Equities filing, supra note 6.
---------------------------------------------------------------------------

    Certain NYSE Alternext members that will be waived in to NYSE do
not currently meet all of NYSE's membership requirements. In a separate
order, the Commission has approved Amex's proposal to give its existing
members a six-month grace period to meet the new NYSE Alternext
membership requirements.\13\ In this proposal, NYSE is offering such
members a similar six-month grace period to meet the NYSE membership
requirements. The Commission believes that this aspect of the proposal
reasonably balances the desire to allow NYSE Alternext members to
continue their businesses and participate in the Relocations with the
need to ensure compliance with applicable membership requirements.
---------------------------------------------------------------------------

    \13\ See Securities Exchange Act Release No. 58705 (October 1,
2008) (SR-Amex-2008-63).
---------------------------------------------------------------------------

IV. Conclusion

    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\14\ that the proposed rule change (SR-NYSE-2008-70) be, and hereby
is, approved.
---------------------------------------------------------------------------

    \14\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\15\
---------------------------------------------------------------------------

    \15\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Florence E. Harmon,
Acting Secretary.
 [FR Doc. E8-23767 Filed 10-7-08; 8:45 am]

BILLING CODE 8011-01-P


[Federal Register: June 5, 2008 (Volume 73, Number 109)]
[Notices]
[Page 32076-32077]
[DOCID:fr05jn08-115]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[Docket No. NHTSA-2008-0103; Notice 1]

Chrysler, LLC, Receipt of Petition for Decision of
Inconsequential Noncompliance

    Chrysler, LLC (Chrysler) has determined that certain vehicles that
it manufactured during the period of March 14, 2006 through March 20,
2008, do not fully comply with paragraph S4.3 of 49 CFR 571.110
(Federal Motor Vehicle Safety Standard (FMVSS) No. 110 Tire Selection
and Rims for Motor Vehicles With a GVWR of 4,536 Kilograms (10,000
Pounds) or Less). Chrysler has filed an appropriate report pursuant to
49 CFR Part 573, Defect and Noncompliance Responsibility and Reports.
    Pursuant to 49 U.S.C. 30118(d) and 30120(h) (see implementing rule
at 49 CFR part 556), Chrysler has petitioned for an exemption from the
notification and remedy requirements of 49 U.S.C. Chapter 301 on the
basis that this noncompliance is inconsequential to motor vehicle
safety.
    This notice of receipt of Chrysler's petition is published under 49
U.S.C. 30118 and 30120 and does not represent any agency decision or
other exercise of judgment concerning the merits of the petition.
    Affected are approximately 1,886 model year 2007-2008 Jeep Wrangler
right-hand drive (RHD) multipurpose passenger vehicles (MPV).
    Paragraphs S4.3 of 49 CFR 571.110 requires in pertinent part that:

    S4.3 Placard. Each vehicle, except for a trailer or incomplete
vehicle, shall show the information specified in S4.3 (a) through
(g), and may show, at the manufacturer's option, the information
specified in S4.3 (h) and (i), on a placard permanently affixed to
the driver's side B-pillar. In each vehicle without a driver's side
B-pillar and with two doors on the driver's side of the vehicle
opening in opposite directions, the placard shall be affixed on the
forward edge of the rear side door. If the above locations do not
permit the affixing of a placard that is legible, visible and
prominent, the placard shall be permanently affixed to the rear edge
of the driver's side door. If this location does not permit the
affixing of a placard that is legible, visible and prominent, the
placard shall be affixed to the inward facing surface of the vehicle
next to the driver's seating position. This information shall be in
the English language and conform in color and format, not including
the border surrounding the entire placard, as shown in the example
set forth in Figure 1 in this standard. At the manufacturer's
option, the information specified in S4.3 (c), (d), and, as
appropriate, (h) and (i) may be shown, alternatively to being shown
on the placard, on a tire inflation pressure label which must
conform in color and format, not including the border surrounding
the entire label, as shown in the example set forth in Figure 2 in
this standard. The label shall be permanently affixed and proximate
to the placard required by this paragraph. The information specified
in S4.3 (e) shall be shown on both the vehicle placard and on the
tire inflation pressure label (if such a label is affixed to provide
the information specified in S4.3 (c), (d), and, as appropriate, (h)
and (i)) may be shown in the format and color scheme set forth in
Figures 1 and 2.

    Chrysler stated that the noncompliance is that the required placard
was installed on the passenger's side (left side) door on each of the
subject RHD vehicles, not on the driver's side (right side) door or B-
pillar as required by FMVSS No. 110.
    Chrysler explains that the subject vehicles were sold primarily for
use by rural postal carriers, since RHD makes it easier for the
carriers to access mailboxes located along the right side of the
roadway. The relevant portion of S4.3 of FMVSS No. 110, entitled
``Placard,'' provides as follows: ``Each vehicle, except for a trailer
or incomplete vehicle, shall show the information specified in S4.3(a)
through (g) * * * on a placard permanently affixed to the driver's side
B-pillar. In each vehicle without a driver's side B-pillar and with two
doors on the driver's side of the vehicle opening in opposite
directions, the placard shall be affixed on the forward edge of the
rear side door. If the above locations do not permit the affixing of a
placard that is legible, visible and prominent, the placard shall be
permanently affixed to the rear edge of the driver's side door.''
    Chrysler further explained that the subject vehicles have placards
that contain all of the tire and vehicle loading information required
by the various subsections of S4.3. However, because of an inadvertent
failure of the assembly plant work instructions to differentiate
between RHD and left hand drive (LHD) vehicles in this respect, the
placards were inadvertently affixed to the rear edge of the door on the
left (passenger) side of the subject vehicles, as opposed to the
driver's side door. (Chrysler notes that the subject vehicles do not
have a B-pillar with a flat surface that would permit the affixing of a
placard that is ``legible, visible, and prominent.'')
    Chrysler states its belief that the fact that the placard required
by paragraph S4.3 of the standard was affixed to the left hand door of
these RHD vehicles--as opposed to the driver's side door--creates
absolutely no risk to motor vehicle safety. All of the relevant tire
and loading information is set forth on the placard, and therefore it
is readily available to vehicle operators. Moreover, the placard is
located at the place where United States drivers are used to looking
for it.
    Chrysler also states its belief that the operators of the subject
vehicles will have almost certainly owned and driven conventional LHD
vehicles, so they will have had experience in locating the tire and
load information on the left side of their vehicles. And in the
extremely unlikely event that an owner has difficulty locating the
placard, the owner's manual provided with the subject vehicles shows
the location of the placard on the left side door.
    Chrysler also makes reference to several previous NHTSA
inconsequential noncompliance decisions that in its opinion are similar
to the instant one.
    Chrysler also notes that it has not received any consumer
complaints

regarding an inability to locate the placard or an unawareness of the
relevant tire and loading information.
    In addition, Chrysler states that it has corrected the problem that
caused these errors so that they will not be repeated in future
production and that it believes that because the noncompliance is
inconsequential to motor vehicle safety that no corrective action is
warranted.
    NHTSA notes that the statutory provisions (49 U.S.C. 30118(d) and
30120(h)) that permit manufacturers to file petitions for a
determination of inconsequentiality allow NHTSA to exempt manufacturers
only from the duties found in sections 30118 and 30120, respectively,
to notify owners, purchasers, and dealers of a defect or noncompliance
and to remedy the defect or noncompliance.
    Interested persons are invited to submit written data, views, and
arguments on this petition. Comments must refer to the docket and
notice number cited at the beginning of this notice and be submitted by
any of the following methods:
    a. By mail addressed to: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590.
    b. By hand delivery to: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590. The Docket Section is open on
weekdays from 10 a.m. to 5 p.m. except Federal Holidays.
    c. Electronically: by logging onto the Federal Docket Management
System (FDMS) website at http://www.regulations.gov/. Follow the online
instructions for submitting comments. Comments may also be faxed to 1-
202-493-2251.
    The petition, supporting materials, and all comments received
before the close of business on the closing date indicated below will
be filed and will be considered. Please note that we are allowing just
10 days for comment in order to expedite resolution of this matter. All
comments and supporting materials received after the closing date will
also be filed and will be considered to the extent possible. When the
petition is granted or denied, notice of the decision will be published
in the Federal Register pursuant to the authority indicated below.
    Comment closing date: June 16, 2008.

    Authority: 49 U.S.C. 30118, 30120: delegations of authority at
CFR 1.50 and 501.8.

    Issued on: May 29, 2008.
Claude H. Harris,
Director, Office of Vehicle Safety Compliance.
[FR Doc. E8-12548 Filed 6-4-08; 8:45 am]

BILLING CODE 4910-59-P


[Federal Register Volume 88, Number 140 (Monday, July 24, 2023)]
[Notices]
[Page 47495]
[FR Doc No: 2023-15629]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2023-0067; FRL-10578-06-OCSPP]

Pesticide Product Registration; Receipt of Applications for New
Uses June 2023

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: EPA has received applications to register new uses for
pesticide products containing currently registered active ingredients.
Pursuant to the Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA), EPA is hereby providing notice of receipt and opportunity to
comment on these applications.

DATES: Comments must be received on or before August 23, 2023.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2023-0067, through the Federal eRulemaking
Portal at https://www.regulations.gov. Follow the online instructions
for submitting comments. Do not submit electronically any information
you consider to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute. Additional
instructions on commenting and visiting the docket, along with more
information about dockets generally, is available at https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Madison Le, Biopesticides and
Pollution Prevention Division (BPPD) (7511M), main telephone number:
(202) 566-1400, email address: [email protected]; or Charles Smith,
Registration Division (RD) (7505T), main telephone number: (202) 566-
2427, email address: [email protected]. The mailing address for each
contact person is Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001. As part of the mailing address, include the contact person's
name, division, and mail code. The division to contact is listed at the
end of each application summary.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

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

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 email. 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 preparing and submitting
your comments, see the commenting tips at https://www.epa.gov/dockets/commenting-epa-dockets.

II. Registration Applications

    EPA has received applications to register new uses for pesticide
products containing currently registered active ingredients. Pursuant
to the provisions of FIFRA section 3(c)(4) (7 U.S.C. 136a(c)(4)), EPA
is hereby providing notice of receipt and opportunity to comment on
these applications. Notice of receipt of these applications does not
imply a decision by the Agency on these applications.

Notice of Receipt--New Uses

    EPA Registration Numbers: 241-245 and 241-418. Docket ID number:
EPA-HQ-OPP-2023-0308. Applicant: BASF Corporation, 26 Davis Drive,
Research Triangle Park, NC 27709. Active ingredient: Pendimethalin.
Product type: Herbicide. Proposed use: Tropical and subtropical fruit,
Medium to large fruit, edible peel subgroup 23B. Contact: RD.
    EPA Registration Number: 55146-162. Docket ID number: EPA-HQ-OPP-
2023-0293. Applicant: Nufarm Americas Inc., AGT Division, 11901 S
Austin Avenue, Alsip, IL 60803. Active ingredient: Cis-Jasmone at
0.88%. Product type: Nematicide. Proposed use: Commercial use for seed
treatment and in-furrow on crops. Contact: BPPD.
    EPA Registration Number: 55146-163. Docket ID number: EPA-HQ-OPP-
2023-0293. Applicant: Nufarm Americas Inc., AGT Division, 11901 S
Austin Avenue, Alsip, IL 60803. Active ingredient: Cis-Jasmone at
93.0%. Product type: Nematicide. Proposed use: For formulation into
commercial seed treatment. Contact: BPPD.
    EPA Registration Numbers: 59639-185 and 59639-211. Docket ID
number: EPA-HQ-OPP-2023-0259. Applicant: Valent U.S.A. LLC, 4600 Norris
Canyon Rd., San Ramon, CA 94583. Active ingredient: Ethaboxam. Product
type: Fungicide. Proposed use: Leaf petiole vegetable subgroup 22B
(greenhouse use only). Contact: RD.
    File Symbol: 87895-O. Docket ID number: EPA-HQ-OPP-2022-0709.
Applicant: AgLogic Chemical, LLC., 121 Estes Dr., Ste. 101, Chapel
Hill, NC 27514. Active ingredient: Aldicarb. Product type: Insecticide.
Proposed use: Oranges and grapefruit in nine counties in Florida.
Contact: RD.
    EPA Registration Number: 87895-2. Docket ID number: EPA-HQ-OPP-
2022-0709. Applicant: AgLogic Chemical, LLC., 121 Estes Dr., Ste. 101,
Chapel Hill, NC 27514. Active ingredient: Aldicarb. Product type:
Insecticide. Proposed use: Oranges and grapefruit in nine counties in
Florida. Contact: RD.
    EPA Registration Number: 94485-4. Docket ID number: EPA-HQ-OPP-
2023-0324. Applicant: Plant Health Intermediate Inc. DBA DPH
Biologicals, 1550 East Old 210 Highway, Liberty, MO 64068. Active
ingredient: Bacillus amyloliquefaciens strain ENV503. Product type:
Fungicide. Proposed use: For use on turf and professional landscape in
residential areas. Contact: BPPD.
    Authority: 7 U.S.C. 136 et seq.

    Dated: July 18, 2023.
Delores Barber,
Director, Information Technology and Resources Management Division,
Office of Program Support.
[FR Doc. 2023-15629 Filed 7-21-23; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 84, Number 200 (Wednesday, October 16, 2019)]
[Notices]
[Pages 55372-55373]
[FR Doc No: 2019-22506]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2016-0315]

Qualification of Drivers; Exemption Applications; Epilepsy and
Seizure Disorders

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

ACTION: Notice of final disposition.

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SUMMARY: FMCSA announces its decision to renew exemptions for three
individuals from the requirement in the Federal Motor Carrier Safety
Regulations (FMCSRs) that interstate commercial motor vehicle (CMV)
drivers have ``no established medical history or clinical diagnosis of
epilepsy or any other condition which is likely to cause loss of
consciousness or any loss of ability to control a CMV.'' The exemptions
enable these individuals who have had one or more seizures and are
taking anti-seizure medication to continue to operate CMVs in
interstate commerce.

DATES: The exemptions were applicable on May 5, 2019. The exemptions
expire on May 5, 2021.

FOR FURTHER INFORMATION CONTACT: Ms. Christine A. Hydock, Chief,
Medical Programs Division,<PHONE_NUMBER><EMAIL_ADDRESS>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.,
ET, Monday through Friday, except Federal holidays. If you have
questions regarding viewing or submitting material to the docket,
contact Docket Services,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Public Participation

A. Viewing Documents and Comments

    To view comments, as well as any documents mentioned in this notice
as being available in the docket, go to http://www.regulations.gov/docket?D=FMCSA-2019-0315 and choose the document to review. If you do
not have access to the internet, you may view the docket online by
visiting the Docket Management Facility in Room W12-140 on the ground
floor of the DOT West Building, 1200 New Jersey Avenue SE, Washington,
DC 20590, between 9 a.m. and 5 p.m., ET, Monday through Friday, except
Federal holidays.

B. 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 www.regulations.gov, as described in the system
of records notice (DOT/ALL-14 FDMS), which can be reviewed at
www.dot.gov/privacy.

II. Background

    On July 15, 2019, FMCSA published a notice announcing its decision
to renew exemptions for three individuals from the epilepsy and seizure
disorders prohibition in 49 CFR 391.41(b)(8) to operate a CMV in
interstate commerce and requested comments from the public (84 FR
33808). The public comment period ended on August 14, 2019, and no
comments were received.
    FMCSA has evaluated the eligibility of these applicants and
determined that renewing these exemptions would achieve a level of
safety equivalent to, or greater than, the level that would be achieved
by complying with Sec.  391.41(b)(8).
    The physical qualification standard for drivers regarding epilepsy
found in Sec.  391.41(b)(8) states that a person is physically
qualified to drive a CMV if that person has no established medical
history or clinical diagnosis of epilepsy or any other condition which
is likely to cause the loss of consciousness or any loss of ability to
control a CMV.
    In addition to the regulations, FMCSA has published advisory
criteria \1\ to assist medical examiners in determining whether drivers
with certain medical conditions are qualified to operate a CMV in
interstate commerce.
---------------------------------------------------------------------------

    \1\ These criteria may be found in APPENDIX A TO PART 391--
MEDICAL ADVISORY CRITERIA, section H. Epilepsy: Sec.  391.41(b)(8),
paragraphs 3, 4, and 5, which is available on the internet at
https://www.gpo.gov/fdsys/pkg/CFR-2015-title49-vol5/pdf/CFR-2015-title49-vol5-part391-appA.pdf.
---------------------------------------------------------------------------

III. Discussion of Comments

    FMCSA received no comments in this preceding.

IV. Conclusion

    Based on its evaluation of the three renewal exemption
applications, FMCSA announces its decision to exempt the following
drivers from the epilepsy and seizure disorders prohibition in Sec.
391.41(b)(8).
    As of May 5, 2019, and in accordance with 49 U.S.C. 31136(e) and
31315(b), the following three individuals have satisfied the renewal
conditions for obtaining an exemption from the epilepsy and seizure
disorders prohibition in the FMCSRs for interstate CMV drivers (84 FR
33808): Brian Brown (PA); Adam Cutler (MA); and Larry Henington (UT).
    The drivers were included in docket number FMCSA-2016-0315. Their
exemptions are applicable as of May 5, 2019, and will expire on May 5,
2021.
    In accordance with 49 U.S.C. 31315(b), each exemption will be valid
for 2 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(e) and
31315(b).

    Issued on: October 4, 2019.
Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2019-22506 Filed 10-15-19; 8:45 am]
BILLING CODE 4910-EX-P


[Federal Register Volume 77, Number 90 (Wednesday, May 9, 2012)]
[Rules and Regulations]
[Pages 27130-27134]
[FR Doc No: 2012-10950]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2010-0261; FRL-9339-6]

Ametoctradin; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes tolerances for residues of
ametoctradin in or on multiple commodities which are identified and
discussed later in this document. BASF Corporation requested these
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective May 9, 2012. Objections and
requests for hearings must be received on or before July 9, 2012, and
must be filed in accordance with the instructions provided in 40 CFR
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2010-0261. 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., 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 (703)
305-5805.

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

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to those
engaged in the following activities:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    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 get electronic access to other related information?

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

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

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must

identify docket ID number EPA-HQ-OPP-2010-0261 in the subject line on
the first page of your submission. All objections and requests for a
hearing must be in writing, and must be received by the Hearing Clerk
on or before July 9, 2012. Addresses for mail and hand delivery of
objections and hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket. Information not marked confidential pursuant to 40 CFR part 2
may be disclosed publicly by EPA without prior notice. Submit a copy of
your non-CBI objection or hearing request, identified by docket ID
number EPA-HQ-OPP-2010-0261, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online 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>.

II. Summary of Petitioned-for Tolerance

    In the Federal Register of May 19, 2010 (75 FR 28009) (FRL-8823-2),
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 0F7695)
by BASF Corporation, 26 Davis Drive, Research Triangle Park, NC. The
petition requested that 40 CFR part 180 be amended by establishing
tolerances for residues of the fungicide ametoctradin, including its
metabolites and degradates, in or on brassica, head and stem, subgroup
5A at 12 parts per million (ppm); brassica, leafy greens, subgroup 5B
at 50 ppm; grape at 5.0 ppm; grape, raisin at 8 ppm; hop, dried cones
at 9 ppm; onion, bulb, subgroup 3-07A at 1.2 ppm; onion, green,
subgroup 3-07B at 16 ppm; vegetable, cucurbit, group 9 at 4.5 ppm;
vegetable, fruiting, group 8-10 at 2 ppm; vegetable, leafy, except
brassica, group 4, at 70 ppm, and vegetable, tuberous and corm,
subgroup 1C at 0.05 ppm. That notice referenced a summary of the
petition prepared by BASF Corporation, the registrant, which is
available in the docket, http://www.regulations.gov. There were no
comments received in response to the notice of filing.
    Based upon review of the data supporting the petition, EPA has
proposed different tolerance levels under a cooperative global review
process. The reason for these changes are explained in Unit IV.D.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. * *
*''
    Consistent with section 408(b)(2)(D) of FFDCA, and the factors
specified in section 408(b)(2)(D) of FFDCA, 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 ametoctradin including
exposure resulting from the tolerances established by this action.
EPA's assessment of exposures and risks associated with ametoctradin
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.
    In toxicity testing with ametoctradin, no single dose or repeated
dose study performed by any route of exposure produced a significant
toxic effect up to or within 75-80% of the limit dose (1000 mg/kg/day).
This includes the studies performed with the ametoctradin metabolites.
There was also no evidence of carcinogenicity or mutagenicity and
therefore ametoctradin is considered ``Not Likely to Be Carcinogenic to
Humans''.
    Specific information on the studies received and the nature of the
adverse effects caused by ametoctradin as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in document ``BAS 650 F (Ametoctradin): Human
Health Risk Assessment for the Proposed New Fungicide Active
Ingredient,'' at p. 10 in docket ID number EPA-HQ-OPP-2010-0261.

 B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors are used in conjunction with
the POD to calculate a safe exposure level--generally referred to as a
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe
margin of exposure (MOE). For non-threshold risks, the Agency assumes
that any amount of exposure will lead to some degree of risk. Thus, the
Agency estimates risk in terms of the probability of an occurrence of
the adverse effect expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm. Based on the available data,
there were no adverse acute or chronic effects identified as to any
population groups (including infants and children).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary

exposure to ametoctradin, EPA considered exposure under the petitioned-
for tolerances. EPA assessed dietary exposures from ametoctradin in
food as follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure. No such effects were
identified in the toxicological studies for ametoctradin; therefore, a
quantitative acute dietary exposure assessment is unnecessary.
    ii. Chronic exposure. No chronic dietary exposure assessment was
conducted because no chronic effect of concern was identified in the
available data.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that ametoctradin does not pose a cancer risk to humans.
Therefore, a dietary exposure assessment for the purpose of assessing
cancer risk is unnecessary.
    2. Dietary exposure from drinking water. Exposure to ametoctradin
via drinking water from the proposed uses is expected to be minimal
based on its short half life in soil. Ametoctradin degradates (F01,
F02, F03, F04) are likely to contribute much greater drinking water
exposure because they are more persistent and more mobile than the
parent. However, no adverse effects were observed in the submitted
toxicological studies for ametoctradin regardless of the route of
exposure. Thus, no drinking water exposure assessments are needed.
    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). Ametoctradin is not
registered for homeowner uses; however, some of the proposed uses could
be used by commercial applicators in areas that residential
postapplication exposure could occur (i.e., ornamentals on golf courses
or in residential landscapes). No adverse effects were observed in the
submitted toxicological studies for ametoctradin regardless of the
route of exposure. Thus, no residential handler or postapplication
exposure assessments are needed.
    4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
    EPA has not found ametoctradin to share a common mechanism of
toxicity with any other substances, and ametoctradin does not appear to
produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
ametoctradin does not have a common mechanism of toxicity with other
substances. For information regarding EPA's efforts to determine which
chemicals have a common mechanism of toxicity and to evaluate the
cumulative effects of such chemicals, see EPA's Web site at http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA Safety
Factor (SF). In applying this provision, EPA either retains the default
value of 10X, or uses a different additional safety factor when
reliable data available to EPA support the choice of a different
factor.
    2. Prenatal and postnatal sensitivity. Based on the complete
database, there were no adverse effects noted in the developmental
toxicity or reproductive toxicity studies.
    3. Conclusion. Based on review of the available ametoctradin
toxicological studies, no toxicological points of departure where
selected for ametoctradin and thus, an additional safety factor to
protect children is not needed. That decision is based on the following
findings:
    i. The toxicity database for ametoctradin is complete.
    ii. There is no indication that ametoctradin is a neurotoxic
chemical and there is no need for a developmental neurotoxicity study
or additional UFs to account for neurotoxicity.
    iii. There is no evidence that ametoctradin results in increased
susceptibility in in utero rats or rabbits in the prenatal
developmental studies or in young rats in the 2-generation reproduction
study.
    iv. There are no concerns identified with regard to exposure to
ametoctradin and thus there are no uncertainties identified in the
exposure databases.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
aPAD and cPAD. For linear cancer risks, EPA calculates the lifetime
probability of acquiring cancer given the estimated aggregate exposure.
Short-, intermediate-, and chronic-term risks are evaluated by
comparing the estimated aggregate food, water, and residential exposure
to the appropriate PODs to ensure that an adequate MOE exists.
    1. Acute risk. An acute aggregate risk assessment takes into
account acute exposure estimates from dietary consumption of food and
drinking water. No adverse effect resulting from a single oral exposure
was identified and no acute dietary endpoint was selected. Therefore,
ametoctradin is not expected to pose an acute risk.
    2. Chronic risk. No adverse effect resulting from a chronic
exposure was identified and no chronic endpoint was selected.
Therefore, ametoctradin is not expected to pose a chronic risk.
    3. Short-term risk. Short-term aggregate exposure takes into
account short-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level). Because no
short-term adverse effect was identified, ametoctradin is not expected
to pose a short-term risk.
    4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level). Because no intermediate-term adverse effect was identified,
ametoctradin is not expected to pose a intermediate-term risk.
    5. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, ametoctradin is not expected to pose a cancer risk to 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 ametoctradin residues.

V. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology using liquid chromatography tandem
mass spectrometry (LC/MS/MS) is available to enforce the tolerance
expression. The method may be requested from: Chief, Analytical
Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft.
Meade, MD 20755-5350; telephone number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint U.N. Food and
Agriculture Organization/World Health Organization food standards
program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level. The Codex has not
established a MRL for ametoctradin.

C. Revisions to Petitioned-for Tolerances

    Ametoctradin is a candidate for global registration in the USA,
Australia, and Canada and import tolerance establishment in the
European Union (EU) for varying uses. Under a cooperative joint review
process, harmonized MRLs were proposed by the Agency, the Pesticide
Management Regulatory Agency of Canada (PMRA), and the EU.
    Although much effort was made to harmonize with the EU proposed
import-MRLs, there remained a few crops (celery, broccoli, cucumber and
hops) where the proposed global registration recommended MRLs differed.
This is primarily because EU's practice for setting MRLs is to lower
the MRL as much as possible hence they try to assign MRLs to selected
individual crops within a crop group as opposed to assigning a crop
group MRL which is normally higher than all the estimated MRLs for
individual crops. This approach is impractical for North American Free
Trade Agreement (NAFTA) regions as there are other crops within a crop
group petitioned for registration.
    The Organization for Economic Co-operation and Development's (OECD)
MRL calculation procedures used to estimate the proposed MRLs. The MRLs
were derived using the average of individual residue data points from
each field trial conducted at maximum applications rates and the lowest
PHI, and assuming the presence of adjuvants (as indicated on the
proposed labels). In estimating MRLs for crop groups, the highest
estimated MRL for individual representative crops were selected.
    For some crops, field trials were conducted at concentrated and
diluted solutions. In these cases, MRLs were chosen using only the
residue data for applications with concentrated solution if the
concentrated solution residue data showed significant differences from
the whole residue dataset (concentrated and diluted solution
applications).

 V. Conclusion

    Therefore, tolerances are established for residues of ametoctradin,
including its metabolites and degradates, in or on brassica, head and
stem, subgroup 5A at 9.0 ppm; brassica, leafy greens, subgroup 5B at 50
ppm; grape at 4.0 ppm; grape, raisin at 8.0 ppm; hop, dried cones at 10
ppm; onion, bulb, subgroup 3-07A at 1.5 ppm; onion, green, subgroup 3-
07B at 20 ppm; spinach at 50 ppm; vegetable, cucurbit, group 9 at 3.0
ppm; vegetable, fruiting, group 8-10 at 1.5 ppm; vegetable, leafy,
except brassica, group 4, except spinach at 40 ppm; and vegetable,
tuberous and corm, subgroup 1C at 0.05 ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances 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 final rule has been
exempted from review under Executive Order 12866, this final rule is
not subject to Executive Order 13211, entitled Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
Protection of Children from Environmental Health Risks and Safety Risks
(62 FR 19885, April 23, 1997). This final rule does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any
special considerations under Executive Order 12898, entitled Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under 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 9, 2000) do not apply to this final rule. In addition,
this final rule does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (Pub. L. 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: April 27, 2012.
Steven Bradbury,
Director, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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

0
2. Add Sec.  180.663 to read as follows:

Sec.  180.663  Ametoctradin; tolerances for residues.

    (a) General. Tolerances are established for residues of the
fungicide ametoctradin, including its metabolites and degradates, in or
on the commodities in the following table. Compliance with the
tolerance levels specified in the following table is to be determined
by measuring only ametoctradin (5-ethyl-6-octyl[1,2,4]triazolo[1,5-
a]pyrimidin-7-amine).

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Brassica, head and stem, subgroup 5A........................         9.0
Brassica, leafy greens, subgroup 5B.........................          50
Grape.......................................................         4.0
Grape, raisin...............................................         8.0
Hop, dried cones............................................        10.0
Onion, bulb, subgroup 3-07A.................................         1.5
Onion, green, subgroup 3-07B................................        20.0
Spinach.....................................................        50.0
Vegetable, cucurbit, group 9................................         3.0
Vegetable, fruiting, group 8-10.............................         1.5
Vegetable, leafy, except Brassica, group 4, except spinach..        40.0
Vegetable, tuberous and corm, subgroup 1C...................        0.05
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[FR Doc. 2012-10950 Filed 5-8-12; 8:45 am]
BILLING CODE 6560-50-P