[Federal Register Volume 87, Number 169 (Thursday, September 1, 2022)]
[Notices]
[Pages 53826-53827]
[FR Doc No: 2022-18936]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2013-0109; FMCSA-2013-0442; FMCSA-2013-0444; FMCSA-
2013-0445; FMCSA-2014-0381; FMCSA-2015-0320; FMCSA-2015-0323; FMCSA-
2015-0326; FMCSA-2017-0252; FMCSA-2017-0253; FMCSA-2018-0050; FMCSA-
2019-0033; FMCSA-2019-0206; FMCSA-2020-0046; FMCSA-2020-0047]

Qualification of Drivers; Exemption Applications; Epilepsy and
Seizure Disorders

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

ACTION: Notice of final disposition.

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SUMMARY: FMCSA announces its decision to renew exemptions for 18
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: Each group of renewed exemptions were applicable on the dates
stated in the discussions below and will expire on the dates provided
below.

FOR FURTHER INFORMATION CONTACT: Ms. Christine A. Hydock, Chief,
Medical Programs Division,<PHONE_NUMBER>, [email protected], FMCSA,
DOT, 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 Dockets
Operations,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Public Participation

A. Viewing Comments

    To view comments go to www.regulations.gov. Insert the docket
number, FMCSA-2013-0109, FMCSA-2013-0442, FMCSA-2013-0444, FMCSA-2013-
0445, FMCSA-2014-0381, FMCSA-2015-0320, FMCSA-2015-0323, FMCSA-2015-
0326, FMCSA-2017-0252, FMCSA-2017-0253, FMCSA-2018-0050, FMCSA-2019-
0033, FMCSA-2019-0206, FMCSA-2020-0046, or FMCSA-2020-0047 in the
keyword box, and click ``Search.'' Next, sort the results by ``Posted
(Newer-Older),'' choose the first notice listed, and click ``Browse
Comments.'' If you do not have access to the internet, you may view the
docket online by visiting Dockets Operations in Room W12-140 on the
ground floor of the DOT West Building, 1200 New Jersey Avenue SE,
Washington, DC 20590-0001, between 9 a.m. and 5 p.m., ET, Monday
through Friday, except Federal holidays. To be sure someone is there to
help you, please call<PHONE_NUMBER> or<PHONE_NUMBER> before visiting
Dockets Operations.

B. Privacy Act

    In accordance with 49 U.S.C. 31315(b)(6), DOT solicits comments
from the public on the exemption request. 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,
the comments are searchable by the name of the submitter.

II. Background

    On July 5, 2022, FMCSA published a notice announcing its decision
to renew exemptions for 18 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 (87 FR 39889). The
public comment period ended on August 4, 2022, 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.
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III. Discussion of Comments

    FMCSA received no comments in this proceeding.

IV. Conclusion

    Based on its evaluation of the 18 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).
    In accordance with 49 U.S.C. 31136(e) and 31315(b), the following
groups of drivers received renewed exemptions in the month of July and
are discussed below.
    As of July 1, 2022, and in accordance with 49 U.S.C. 31136(e) and
31315(b), the following 14 individuals have satisfied the renewal
conditions for obtaining an exemption from the epilepsy and seizure
disorders prohibition in the FMCSRs for interstate CMV drivers (87 FR
39889):

David F. Bigler (MN)
Ronald Bohr (IA)
David P. Crowe (VA)
Heath Crowe (LA)
Michael Davis (ME)
Nathan Dermer (AK)
John Johnson (WI)
Anthony Kornuszko (PA)
Raymond Lobo (NJ)
Lucas Meeker (OH)
David Pamperin (WI)
Kevin Sprinkle (NC)
Stephen Soden (LA)
Michael Vitch (MS)
    The drivers were included in docket number FMCSA-2013-0109, FMCSA-
2013-0442, FMCSA-2013-0444, FMCSA-2014-0381, FMCSA-2015-0320, FMCSA-
2015-0323, FMCSA-2015-0326, FMCSA-2017-0252, FMCSA-2017-0253, FMCSA-
2018-0050, FMCSA-2019-0033, FMCSA-2019-0206, or FMCSA-2020-0046. Their
exemptions were applicable as of July 1, 2022 and will expire on July
1, 2024.
    As of July 14, 2022, and in accordance with 49 U.S.C. 31136(e) and
31315(b), Ronald Blount (GA) has satisfied the renewal conditions for
obtaining an exemption from the epilepsy and seizure disorders
prohibition in the FMCSRs for interstate CMV drivers.
    This driver was included in docket number FMCSA-2013-0445. The
exemption was applicable as of July 14, 2022 and will expire on July
14, 2024 (87 FR 39889).
    As of July 21, 2022, 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 (87 FR
39889):

Sonny Chase (MN); Jason Miller (WI); and Michael Morris (OR).

    The drivers were included in docket number FMCSA-2020-0047. Their
exemptions were applicable as of July 21, 2022 and will expire on July
21, 2024.
    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).

Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2022-18936 Filed 8-31-22; 8:45 am]
BILLING CODE 4910-EX-P


[Federal Register: July 9, 2009 (Volume 74, Number 130)]
[Notices]
[Page 33012-33013]
[DOCID:fr09jy09-139]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-60208; File No. SR-ISE-2009-39]

Self-Regulatory Organizations; International Securities Exchange,
LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule
Change Relating to PrecISE Fees

July 1, 2009.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on June 24, 2009, the International Securities Exchange, LLC (the
``Exchange'' or the ``ISE'') filed with the Securities and Exchange
Commission (the ``Commission'') the proposed rule change as described
in Items I, II, and III below, which items have been prepared by the
self-regulatory organization. The Commission is publishing this notice
to solicit comments on the proposed rule change from interested
persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The ISE is proposing to amend the fees for its PrecISE
Trade[supreg] order entry terminals. The text of the proposed rule
change is available on the Exchange's Web site (http://www.ise.com), at
the principal office of the Exchange, and at the Commission's Public
Reference Room.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the self-regulatory organization
included statements concerning the purpose of, and basis for, the
proposed rule change and discussed any comments it received on the
proposed rule change. The text of these statements may be examined at
the places specified in Item IV below. The self-regulatory organization
has prepared summaries, set forth in sections A, B and C below, of the
most significant aspects of such statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    (1) Purpose--The purpose of this proposed rule change is to amend
the ISE's fee schedule for its proprietary PrecISE Trade[supreg] order
entry terminals. ``PrecISE'' is the Exchange's internally-developed
proprietary order-routing terminal used by Electronic Access Members
(``EAM'') to send order flow to ISE. ISE currently charges a monthly
fee of $300 per user per month for the first 10 users; for all
subsequent users, ISE charges $50 per user per month.\3\ ISE recently
upgraded PrecISE, enhancing it with certain new functionalities that,
among other things, provide users with ``Greek'' calculations and the
use of Attributable Orders.\4\ Certain other user-requested
enhancements have also been built into the new version. In order for
ISE to cover the costs of building out the enhanced version, we propose
to increase the fee for the first 10 users to $350 per month and for
all subsequent users, $100 per month.
---------------------------------------------------------------------------

    \3\ See Securities Exchange Act Release No. 55960 (June 26,
2007), 72 FR 36531 (July 3, 2007) (Notice of Filing and Immediate
Effectiveness of a Proposed Rule Change Relating to PrecISE Fees).
    \4\ Attributable Order is a market or limit order in which an
EAM can choose to disclose their member ID. See Securities Exchange
Act Release No. 58701 (October 1, 2008), 73 FR 59007 (October 8,
2008) (Notice of Filing and Immediate Effectiveness of Proposed Rule
Change Relating to a New Order Type) (SR-ISE-2008-74).
---------------------------------------------------------------------------

    ISE also proposes to change the method for calculating this fee.
Currently, EAMs are billed based on the number of maximum concurrent
logins. For example, if an EAM uses five logins over the course of a
month but only three logins were used simultaneously at any point
during the month, that member is charged for just those three logins.
The Exchange now proposes to charge EAMs for the total number of logins
used during the month. Using the same example, EAMs will now be charged
for all five logins that they used over the course of the month. This
proposed fee change will be operative on July 1, 2009.
    (2) Basis--The basis under the Securities Exchange Act of 1934 (the
``Exchange Act'') [sic] for this proposed rule change is the
requirement under Section 6(b)(4) that an exchange have an equitable
allocation of reasonable dues, fees and other charges among its members
and other persons using its facilities. In particular, these fees will
enable the Exchange to cover its costs for providing an enhanced
version of its front-end trading system.

B. Self-Regulatory Organization's Statement on Burden on Competition

    The proposed rule change does not impose any burden on competition
that is not necessary or appropriate in furtherance of the purposes of
the Act.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants or Others

    The Exchange has not solicited, and does not intend to solicit,
comments on this proposed rule change. The Exchange has not received
any unsolicited written comments from members or other interested
parties.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    The foregoing rule change has become effective pursuant to Section
19(b)(3) [sic] of the Act \5\ and Rule 19b-4(f)(2) \6\ thereunder. At
any time within 60 days of the filing of such proposed rule

change, the Commission may summarily abrogate such rule change if it
appears to the Commission that such action is necessary or appropriate
in the public interest, for the protection of investors, or otherwise
in furtherance of the purposes of the Act.
---------------------------------------------------------------------------

    \5\ 15 U.S.C. 78s(b)(3)(A). [sic]
    \6\ 17 CFR 19b-4(f)(2). [sic]
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IV. Solicitation of Comments

    Interested persons are invited to submit written data, views and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://
www.sec.gov/rules/sro.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File Number SR-ISE-2009-39 on the subject line.

Paper Comments

     Send paper comments in triplicate to Elizabeth M. Murphy,
Secretary, Securities and Exchange Commission, 100 F Street, NE.,
Washington, DC 20549-1090.

All submissions should refer to File Number SR-ISE-2009-39. This file
number should be included on the subject line if e-mail is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/
sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for inspection and
copying in the Commission's Public Reference Room, 100 F Street, NE.,
Washington, DC 20549, on official business days between the hours of 10
a.m. and 3 p.m. Copies of such filing also will be available for
inspection and copying at the principal office of ISE. All comments
received will be posted without change; the Commission does not edit
personal identifying information from submissions. You should submit
only information that you wish to make available publicly. All
submissions should refer to File Number SR-ISE-2009-39 and should be
submitted on or before July 30, 2009.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\7\
---------------------------------------------------------------------------

    \7\ 17 CFR 200.30-3(a)(12).
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Elizabeth M. Murphy,
Secretary.
[FR Doc. E9-16176 Filed 7-8-09; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 78, Number 18 (Monday, January 28, 2013)]
[Notices]
[Pages 5817-5818]
[FR Doc No: 2013-01640]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-D-0128; Formerly Docket No. 2007D-0396]

Detecting and Evaluating Drug-Induced Liver Injury; What's
Normal, What's Not, and What Should We Do About It?; Public Conference;
Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public conference; request for comments.

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SUMMARY: The Food and Drug Administration (FDA) is announcing a public
conference entitled ``Detecting and Evaluating Drug-Induced Liver
Injury; What's Normal, What's Not, and What Should We Do About It?''
This conference will be cosponsored with the Critical Path Institute
(C-Path) and the Pharmaceutical Research and Manufacturers of America.
Its purpose is to discuss, debate, and build consensus among
stakeholders in the pharmaceutical industry, academia, health care
providers, patient groups, and regulatory bodies on how best to detect
and assess the severity, extent, and likelihood of drug causation of
liver injury and dysfunction in people using drugs for any medical
purpose.

DATES: The public conference will be held on March 20, 2013, from 8
a.m. to 6 p.m. and March 21, 2013, from 8 a.m. until 4 p.m.

ADDRESSES: The conference will take place at the Marriott Inn &
Conference Center, University of Maryland University College, 3501
University Blvd., East Hyattsville, MD 20783.

FOR FURTHER INFORMATION CONTACT: Lana L. Pauls, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, rm. 4307, Silver Spring MD 20993-0002, 301-
796-0518<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    In July 2009, FDA announced the availability of guidance for
industry entitled ``Drug-Induced Liver Injury: Premarketing Clinical
Evaluation'' (74 FR 38035; July 30, 2009). This guidance explained that
drug-induced liver injury (DILI) was the most frequent cause of safety-
related drug marketing withdrawals for the past 50 years and that
hepatotoxicity has limited use of many drugs that have been approved
and prevented the approval of others. It

discusses methods of detecting DILI by periodic tests of serum enzyme
activities and bilirubin concentration, and how changes in the results
of those laboratory tests over time, along with symptoms and physical
findings, may be used to estimate severity of the injury. It suggests
some ``stopping rules'' for interrupting drug treatment, and the need
to obtain sufficient clinical information to assess causation. FDA
published a draft of this guidance in 2006, and comments on the draft
were taken into consideration when issuing the final guidance in July
2009 (http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM174090.pdf.). FDA
is now interested in obtaining stakeholder input on the issues
addressed in this guidance, including comments regarding potential
revisions to the guidance.

II. The Public Conference

A. Why are we holding this conference?

    The purpose of the 2013 conference is to invite participants to
present their data and views, and to hold open discussion.

B. Registration, Transcripts, and Additional Information on This
Conference and Its Predecessors

    A registration fee ($600 for industry registrants and $300 for
Federal Government and academic registrants) will be charged to help
defray the costs of renting meeting spaces and the meals and snacks
provided. The fee will also be used to cover travel costs incurred by
invited academic (but not Government or Industry) speakers and other
expenses. The registration process will be handled by C-Path, an
independent, nonprofit organization established in 2005 with public and
private philanthropic support from the southern Arizona community,
Science Foundation Arizona, and FDA.
    The presentations and discussions will be transcribed and published
on the Internet for public availability after minor editing by the
organizers of the meeting.
    Additional information on the conference, program, and registration
procedures may be obtained on the Internet at http://www.c-path.org,
and also at http://www.fda.gov by typing into the search box ``liver
toxicity''. (FDA has verified the C-Path Web site address, but is not
responsible for any subsequent changes to the Web site after this
document publishes in the Federal Register.) Material presented at past
programs (from 1999 to 2012) may be accessed at www.aasld.org. Click on
Education/Training and then scroll down to ``Drug Induced Liver Injury
2012 Program.''

    Dated: January 22, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-01640 Filed 1-25-13; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 76, Number 222 (Thursday, November 17, 2011)]
[Notices]
[Pages 71341-71342]
[FR Doc No: 2011-29749]

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ENVIRONMENTAL PROTECTION AGENCY

[FRL-9494-4; Docket ID No. EPA-HQ-ORD-2011-0914]

BASINS and WEPP Climate Assessment Tools: Case Study Guide to
Potential Applications

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of public comment period and letter peer-review.

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SUMMARY: EPA is announcing a 30-day public comment period for the draft
document titled, BASINS and WEPP Climate Assessment Tools (CAT): Case
Study Guide to Potential Applications (EPA/600/R-11/123A). EPA also is
announcing that an EPA contractor for external scientific peer review
will select an independent group of experts to conduct a letter peer-
review of the draft document. The document was prepared by the National
Center for Environmental Assessment within EPA's Office of Research and
Development, and is intended to support application of two recently
developed water modeling tools, the BASINS and WEPP climate assessment
tools. The report presents a series of short case studies designed to
illustrate the capabilities of these tools for conducting scenario
based assessments of the potential future effects of climate, land use,
and management change on water resources.
    EPA intends to forward the public comments that are submitted in
accordance with this notice to the external peer-reviewers for their
consideration during the letter review. When finalizing the draft
document, EPA intends to consider any public comments received in
accordance with this notice. EPA is releasing this draft assessment for
the purposes of public comment and peer review. This draft assessment
is not final as described in EPA's information quality guidelines, and
it does not represent and should not be construed to represent Agency
policy or views.
    The draft document is available via the Internet on the NCEA home
page under the Recent Additions and the Data and Publications menus at
http://www.epa.gov/ncea.

DATES: The 30-day public comment period begins November 17, 2011, and
ends December 19, 2011. Technical comments should be in writing and
must be received by EPA by December 19, 2011.

ADDRESSES: The draft document, BASINS and WEPP Climate Assessment
Tools: Case Study Guide to Potential Applications, is available
primarily via the Internet on the National Center for Environmental
Assessment's home page under the Recent Additions and the Data and
Publications menus at http://www.epa.gov/ncea. A limited number of
paper copies are available from the Information Management Team, NCEA;
telephone:<PHONE_NUMBER>; facsimile:<PHONE_NUMBER>. If you are
requesting a paper copy, please provide your name, mailing address, and
the document title.
    Comments may be submitted electronically via http://www.regulations.gov, by mail, by facsimile, or by hand delivery/
courier. Please follow the detailed instructions provided in the
SUPPLEMENTARY INFORMATION section of this notice.

FOR FURTHER INFORMATION CONTACT: For information on the public comment
period, contact the Office of Environmental Information Docket;
telephone:<PHONE_NUMBER>; facsimile:<PHONE_NUMBER>; or email:
<EMAIL_ADDRESS>    For technical information, contact Thomas Johnson, NCEA; telephone:
(703) 347-8618; facsimile:<PHONE_NUMBER>; or email:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Information About the Project/Document

    There is growing concern about the potential effects of climate
change on water resources. U.S. EPA and partners have developed two
assessment tools, the BASINS Climate Assessment Tool (BASINS CAT) and
the Water Erosion Prediction Project Climate Assessment Tool (WEPPCAT),
that facilitate application of existing simulation models for
conducting scenario-based assessments of potential climate change
impacts on water.
    This report presents a series of short case studies using the
BASINS and WEPP climate assessment tools. The case studies are designed
to illustrate the capabilities of these tools for conducting
assessments of the potential future effects of climate, land use, and
management change on water resources. Climate change scenarios are
created based on model projections as well as historical data and past
events. Land use change and management scenarios are also included to
address questions related to the relative effects of land use versus
climate change, and the effectiveness of management practices for
reducing impacts.
    This report is technical in nature. It is of interest to modeling
professionals including water and watershed managers, urban or regional
planners, government officials, and scientists and engineers interested
in using the BASINS or WEPP water models to assess the potential
implications of climate change on water resources.

II. How To Submit Technical Comments to the Docket at
www.regulations.gov

    Submit your comments, identified by Docket ID No. EPA-HQ-ORD 2011-
0914, by one of the following methods:
     www.regulations.gov: Follow the on-line instructions for
submitting comments;
     Email<EMAIL_ADDRESS>     Fax:<PHONE_NUMBER>;
     Mail: Office of Environmental Information (OEI) Docket
(Mail Code: 28221T), U.S. Environmental Protection Agency, 1200
Pennsylvania Avenue, NW., Washington, DC 20460. The phone number is
(202) 566-1752. If you provide comments by mail, please submit one
unbound original with pages

numbered consecutively and three copies of the comments. For
attachments, provide an index, number pages consecutively with the
comments, and submit an unbound original and three copies; or
     Hand Delivery: The OEI Docket is located in the EPA
Headquarters Docket Center, EPA West Building, Room 3334, 1301
Constitution Avenue, NW., Washington, DC. The EPA Docket Center's
Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is<PHONE_NUMBER>. Deliveries are only accepted during the
docket's normal hours of operation, and special arrangements should be
made for deliveries of boxed information. If you provide comments by
hand delivery, please submit one unbound original with pages numbered
consecutively and three copies of the comments. For attachments,
provide an index, number pages consecutively with the comments, and
submit an unbound original and three copies.
    Instructions: Direct your comments to Docket ID No. EPA-HQ-ORD-
2011-0914. Please ensure that your comments are submitted within the
specified comment period. Comments received after the closing date will
be marked ``late,'' and may only be considered if time permits. It is
EPA's policy to include all comments it receives in the public docket
without change and to make the comments available online at http://www.regulations.gov, including any personal information provided,
unless a comment includes information claimed to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Do not submit information that you consider to
be CBI or otherwise protected through http://www.regulations.gov or
email. The http://www.regulations.gov Web site is an ``anonymous
access'' system, which means EPA will not know your identity or contact
information unless you provide it in the body of your comment. If you
send an email comment directly to EPA without going through http://www.regulations.gov, your email address will be automatically captured
and included as part of the comment that is placed in the public docket
and made available on the Internet. If you submit an electronic
comment, EPA recommends that you include your name and other contact
information in the body of your comment and with any disk or CD-ROM you
submit. If EPA cannot read your comment due to technical difficulties
and cannot contact you for clarification, EPA may not be able to
consider your comment. Electronic files should avoid the use of special
characters, any form of encryption, and be free of any defects or
viruses. For additional information about EPA's public docket visit the
EPA Docket Center homepage at http://www.epa.gov/epahome/dockets.htm.
    Docket: Documents in the docket are listed in the http://www.regulations.gov index. Although listed in the index, some
information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other materials,
such as copyrighted material, are publicly available only in hard copy.
Publicly available docket materials are available either electronically
at http://www.regulations.gov or in hard copy at the OEI Docket in the
EPA Headquarters Docket Center.

    Dated: November 10, 2011.
Darrell A. Winner,
Acting Director, National Center for Environmental Assessment.
[FR Doc. 2011-29749 Filed 11-16-11; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: September 17, 2010 (Volume 75, Number 180)]
[Notices]
[Page 57045-57048]
[DOCID:fr17se10-111]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare and Medicaid Services

Food and Drug Administration

[Docket No. FDA-2010-N-0308]

Parallel Review of Medical Products

AGENCIES: Centers for Medicare and Medicaid Services; Food and Drug
Administration, HHS.

ACTION: Notice; request for comments.

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SUMMARY: The Food and Drug Administration (FDA) and the Centers for
Medicare and Medicaid Services (CMS) are considering establishing a
process for overlapping evaluations of premarket, FDA-regulated medical
products when the product sponsor and both agencies agree to such
parallel review. This process will serve the public interest by
reducing the time between FDA marketing approval or clearance decisions
and CMS national coverage determinations (NCDs). The agencies are
establishing a docket to receive information and comment from the
public on what products would be appropriate for parallel review by the
two agencies, what procedures should be developed, how a parallel
review process should be implemented, and other issues related to the
effective operation of the process. The agencies are also announcing
their intent to create a pilot program for parallel review of medical
devices. The pilot program will begin after both agencies have reviewed
the public comments on this notice. A memorandum of understanding (MOU)
concerning the exchange of data and information has been completed
between the two agencies. See http://www.fda.gov/AboutFDA/
PartnershipsCollaborations/MemorandaofUnderstandingMOUs/DomesticMOUs/
ucm217585.htm.

DATES: Submit either electronic or written comments by December 16,
2010.

ADDRESSES: 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.

FOR FURTHER INFORMATION CONTACT:
    General questions about parallel review: Peter Beckerman, Office of
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Silver
Spring, MD 20993-0002,<PHONE_NUMBER>, e-mail:
<EMAIL_ADDRESS>or Tamara Syrek Jensen, Centers for
Medicare and Medicaid Services, 7500 Security Blvd., Baltimore, MD
21244, e-mail<EMAIL_ADDRESS>    For device sponsors interested in requesting voluntary parallel
review: Markham C. Luke, Center for Devices and Radiological Health,
Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring,
MD 20993-0002,<PHONE_NUMBER>, e-mail<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    FDA and CMS share a common interest in improving the health of
patients through the availability of safe, effective, and affordable
medical products and fostering medical product innovations.
    The mission of the FDA is to protect and promote the public health.
It accomplishes this task, in part, by the following:
     Assuring the safety, efficacy, and quality of human drugs,
biological products, and medical devices;
     Fostering innovations to make medical products safer and
more effective; and
     Helping health care providers and the public get the
accurate, science-based information they need to use medical products
to improve public health.
    The mission of CMS is to ensure effective, up-to-date Medicare
coverage and to promote the continual improvement of the quality care
for its beneficiaries. CMS accomplishes this mission by continuing to
transform and modernize America's health care system, in part, by the
following:
     Fostering accurate and predictable payments,
     Ensuring high-value health care,
     Promoting understanding of CMS programs among
beneficiaries, the health care community, and the public.
    Through coordinated decisions regarding medical products, FDA and
CMS can affect public health in critical ways: FDA in determining the
safety and effectiveness of those products and CMS in providing
beneficial coverage and appropriate payment for covered items and
services involving those products. Both agencies believe they should
address the growing need to improve public health by speeding consumer
access to and spurring the development of new, affordable, reliable,
safer, and more effective medical products and services. FDA and

CMS are working together to identify areas in which they can
collaborate to achieve these goals and parallel review provides one
such opportunity.

A. Innovative Medical Products are Difficult to Develop

    The recent boom in new basic science discoveries has generated hope
for the development of new treatments and diagnostics for serious
illnesses. However, there is concern as to whether there are adequate
resources available for bringing the most innovative medical devices to
market. The number of new drug and biologic applications submitted to
FDA has been declining for several years for reasons not wholly clear.
Inefficiencies and rising costs appear to account for only part of the
reluctance to embark on new medical product development. The limited
predictability of market access may also hinder investment in the
development of innovative therapies and diagnostics. Reducing the time
between marketing approval or clearance and obtaining third party
payment (``approval-to-payment'' time) can produce savings for sponsors
and improve public health through overlapping medical review of data/
evidence leading to more timely patient access to those new products.
    Currently, medical product development and coverage and payment of
new therapies and diagnostics generally occur in a serial manner.
First, a new medical product is submitted to FDA, which determines
whether it meets applicable safety and effectiveness standards for
commercial marketing. Next, the company seeks coverage from the payer
who in turn determines the payment rate for the product.
    Timely access to innovative medical technologies has been
identified as a significant issue in the delivery of high quality
health care. Manufacturers of innovative medical products have said
that after undergoing the FDA approval process the availability of
their products to consumers is often slow because, in order to obtain
coverage and payment from third-party payers, the manufacturers must go
through a second review process by such payers. This is in part because
the materials submitted by manufacturers for FDA review are, for
various reasons, not generally made available to third-party payers
prior to FDA approval or clearance. In addition, the materials
submitted by manufacturers to FDA may not adequately address the issues
of importance to payers, such as community or home based use outside of
clinical trial protocols, generalizability of the results to target
populations that may have not been studied, and the incremental
clinical utility of these products compared to currently available
technologies.
    Although CMS is only one of many third-party payers and provides
insurance benefits to select populations, the agency plays a leading
role in healthcare through its coverage and payment decisions. Because
many third-party payers tend to follow CMS' lead, a positive national
coverage or payment decision by CMS often promotes rapid adoption of a
new therapy by the medical community. However, a positive coverage
decision after a long time lag following FDA approval or clearance can
delay consumer access to new medical products.

B. Differences in FDA and CMS Review

    FDA premarket review and CMS national coverage determinations
differ significantly. Each process operates under different statutory
standards and each asks different questions to meet its respective
mandates. The FDA premarket review generally assesses the safety and
effectiveness of these medical products. Even within FDA's review
processes, there are differences in types of evaluation depending upon
the application under consideration (for example, premarket approval
applications (PMAs) must meet standards different from premarket
notifications (510(k)s)).
    CMS serves a different function by providing health insurance to
protect the nation's aged and disabled persons from the substantial
burdens of illness. Under section 1862(a)(1) of the Social Security Act
(the Act), CMS makes determinations regarding the coverage of specific
items and services. In short, CMS must make multiple decisions: It must
decide what items and services it can and should pay for; how it should
accomplish the payment; and how much to pay.
    CMS' evaluation of medical products depends on the type of request.
For most NCDs, CMS evaluates whether a medical product or service is
reasonable and necessary to diagnose or treat an illness or injury
affecting the Medicare population. This evaluation includes review of
appropriate outcomes data, such as whether the product provides
improved, equivalent, or complementary health outcomes in the Medicare
population as compared to alternative treatments or diagnostics already
covered by the program. CMS may also evaluate medical product
indications that have not been approved or cleared by FDA, so-called
unapproved or off-label uses.

C. Parallel Review--Opportunity To Speed Patient Access To Beneficial
Medical Products

    Under current practice, CMS does not routinely undertake an NCD
unless it receives a complete formal external request. At times, CMS
may also internally generate a request. Because local fiscal
intermediaries, carriers, or Medicare Administrative Contractors are
able to make decisions within their own jurisdictions, Medicare
coverage and payment can occur in the absence of a NCD, such as from
the initial market availability of a new technology.
    CMS usually begins its national coverage decision making process
for FDA-regulated medical products after they have been approved or
cleared by FDA. Because FDA does not approve or clear all the marketing
applications it reviews, such serial processing ensures that CMS does
not expend its limited resources assessing medical products that never
reach the U.S. market. In addition, the CMS NCD process is subject to
strict statutory time limits (9 to 12 months from the opening to
publication of the final decision) that cannot be extended if a
manufacturer should encounter an unexpected delay in obtaining FDA
approval or clearance. However, this serial review process has been
subject to criticism because it potentially causes delay in consumer
access to beneficial medical products. Overlapping evaluations by FDA
and CMS for innovative products could speed consumer access to those
new products by reducing the time span between marketing approval or
clearance decisions and national coverage/payment determinations.
    From time to time CMS finds that developers of new technology fail
to recognize the differences between the regulatory requirements of FDA
and CMS. They may undertake clinical studies that are designed to
address FDA questions but do not adequately address CMS questions
concerning the impact of the technology on Medicare beneficiary health
outcomes. This omission can slow the developer's quest for Medicare
coverage. We believe that a parallel review process can furnish an
opportunity to educate developers regarding clinical study designs that
are more likely to simultaneously address both FDA and CMS questions.
    To potentially accelerate consumer access to new, particularly
innovative, safe and effective medical products, FDA and CMS intend to
establish a process for parallel review. Parallel review could also
create incentives for venture capitalists and companies to increase
their investment in innovative

medical products by reducing the time to return on investment for those
products eligible for parallel review.
    The agencies envision parallel review as a collaborative effort in
which CMS will begin its NCD-related review process to determine
whether the product is reasonable and necessary for the Medicare
population while FDA is completing its premarket review. However,
before developing and implementing such a process, the agencies believe
that important issues must be resolved. For example, to avoid CMS
reaching a coverage determination deadline before FDA has completed its
review process and to minimize the possibility that CMS will begin its
coverage process for a product that is subsequently not approved or
cleared by FDA, the CMS process and FDA process should be carefully
staged. FDA and CMS also seek comment on whether they should establish
a voluntary process to allow companies to meet with both agencies to
develop clinical trial protocols that would meet each agency's
respective statutory standard rather than potentially conducting
separate clinical studies.
    This notice provides the first opportunity for the public to
comment on these issues. The public will have a second opportunity to
provide input should the agencies subsequently issue, as they currently
intend, a joint draft guidance or other appropriate documents,
describing the proposed process. The agencies envision that the
decision to undertake the parallel review process with respect to a
specific product will be at the request of the manufacturer and with
the agreement of both agencies, thus making the process voluntary for
all parties involved. FDA would make its approval or clearance
determination first because CMS would not ordinarily provide coverage
to a product not approved or cleared by FDA for marketing in the United
States. In addition, CMS has statutory requirements (for example, CMS
must issue a proposed coverage decision memorandum for comment) that
make it impossible for the issuance of an NCD simultaneous with an FDA
approval or clearance.
    Parallel review would be a variation of the usual serial review
process. Sponsors would be able to request use of this process in
seeking an NCD. The regulatory standards and evidentiary standards used
by FDA and CMS for decision-making would not change; under any review
scenario, each agency would continue to make its decision under its
respective authority and with its own standards, independent of the
other. The sponsor requesting parallel review would be expected to meet
the legal requirements, including data submission requirements, for
both FDA premarket review or clearance and of an NCD request by CMS.
Once formal procedures are developed, the agencies will work on making
the data submissions efficient and nonduplicative with the intent of
making parallel review less burdensome than if the sponsor went to each
agency in serial fashion. Parallel review between the FDA and CMS would
include only CMS coverage determination reviews and not any reviews of
payment mechanisms.
    By means of this notice, we are opening a public comment docket to
solicit comment from the public on the parallel review process. We are
interested in comments on all aspects of the process as we have
explained it, including what categories of products are most
appropriate for such review, the timing of parallel review, what
procedures should be developed, how such a review process should be
implemented, and what efficiencies could be achieved. After reviewing
the public comments, FDA and CMS intend to issue a joint draft guidance
describing the parallel review process and the procedures each agency
would use for its implementation.
    After review of the public comments on this notice, both agencies
will consider a small number of requests from sponsors of innovative
medical devices for parallel review on a pilot basis. (No new statutory
authorities would be required to pursue such a pilot because FDA and
CMS are continuing to comply with all aspects of current law.) The
agencies will announce procedures for participating in the pilot at
that time as well as criteria for participation. For general questions
about parallel review, contact the persons listed in the ``FOR FURTHER
INFORMATION CONTACT'' section of this document. Device sponsors
interested in requesting voluntary parallel review should contact the
person noted as the contact listed in the ``FOR FURTHER INFORMATION
CONTACT'' section of this notice.

II. Comments

    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 assist interested parties, we are asking for public comment on
the following issues:
    1. Should anyone other than the product sponsor be able to initiate
a request for parallel review (for example, the FDA, CMS, an interested
third party)?
    2. For which classes of products would consumers, payers, or
sponsors benefit most from parallel review? Why?
    3. FDA and CMS may propose to limit the number of products
concurrently under parallel review. How should limits be placed on the
number and/or type of products concurrently under parallel review?
Should CMS be permitted to review indications for which the sponsor is
not seeking FDA clearance or approval under parallel review?
    4. Are there disadvantages to parallel review?
    5. Are there any barriers (for example, regulatory, legal,
scientific) to parallel review and if so, how might they be overcome?
    6. Should a voluntary process be put in place to encourage the
conduct of clinical trials that are appropriately designed to support
both FDA approval/clearance and CMS national coverage decisions? If so,
what process should be established?
    7. What criteria should the FDA and CMS use to decide whether to
grant a request for parallel review?
    8. At what point during FDA premarket review for prescription
drugs, biologics, and medical devices, should parallel review begin in
order to reduce the time between FDA marketing approval or clearance
decisions and CMS national coverage decisions while avoiding the risk
that CMS would initiate an NCD for a product whose premarket
application the FDA subsequently does not approve or clear?
    9. How should parallel review be implemented? Should the agencies
use means in addition to a guidance document, such as designating
agency liaisons, to educate sponsors about parallel review?
    10. When, if at all, should the agencies offer joint meetings to
interested sponsors during parallel review? Before parallel review
begins? Before a premarket application is submitted to the FDA?
    11. Should FDA and CMS have access to the same data and information
about the product during parallel review? (Note: Both agencies will
protect the confidentiality of proprietary information used in the
parallel review process, as they currently do under their

respective approval/clearance and coverage processes.)
    12. It is CMS' policy to inform the public when it begins an NCD
process for a particular product. However, under applicable statutes
and FDA's regulations, the existence of a premarket application is
considered confidential commercial information prior to approval or
clearance unless the sponsor has publicly acknowledged the application.
With the consent of the sponsor, should CMS make public that it has
begun the NCD process, as part of parallel review, for a product still
undergoing FDA premarket review? As a condition of the agencies'
agreement to initiate parallel review, should a sponsor have to inform
the public, or consent to the agencies informing the public, that the
product will be evaluated under parallel review? If the sponsor
declines to consent to disclosure, should it be permitted to request
parallel review anyway, which would prevent CMS from disclosing the NCD
process until after the product is approved by the FDA? How can the
transparency of CMS' NCD process be reconciled with the need to retain
confidentiality of certain commercial information?
    13. At present, sponsors whose medical products will undergo both
FDA premarket review and CMS national coverage review submit separate
application packages to FDA and CMS that, in part, contain the same
data, and, in part, contain different data. Keeping in mind the limited
resources available to the agencies, what steps can the agencies take
to minimize duplication of data submissions? Would the use of
electronic submissions reduce submission burdens and facilitate data
transfers? Are there other steps the agencies can take to streamline a
parallel review process without modifying the regulatory standards and
evidentiary requirements of both agencies? Would the transparency of
CMS' NCD process subject the FDA to additional public pressure
regarding marketing authorization?
    14. Should the agencies convene a joint advisory committee to
consider common issues needing public discussion and advice during the
parallel review process?
    15. What other concerns or considerations should the agencies take
into account when developing a process for parallel review?
    16. Once FDA and CMS have opened a parallel review should a sponsor
be able to terminate or withdraw the request for parallel review? If
this happens, should that information be made public?
    17. Sponsors who submit a PMA or 510(k) to the FDA generally must
pay a user fee. One key advantage of parallel review is to streamline
the current process by allowing engagement by a sponsor with both FDA
and CMS concurrently. Earlier engagement could shorten the time between
FDA approval or clearance of the PMA or 510(k) and a coverage decision
from CMS. Parallel review could, however, entail additional costs for
the agencies (for example, if the product ultimately does not receive
FDA approval or clearance). Changes to a user fee would also require
legislative changes. Given these factors, should the current Medical
Device User Fee be restructured to support the FDA and CMS costs of
this parallel review and if so, how?

    Dated: September 10, 2010.
Margaret A. Hamburg,
Commissioner of Food and Drugs.

    Dated: July 29, 2010.
Donald M. Berwick,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2010-23252 Filed 9-16-10; 8:45 am]
BILLING CODE 4160-01-S


[Federal Register: February 28, 2007 (Volume 72, Number 39)]
[Notices]
[Page 9051-9052]
[DOCID:fr28fe07-104]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-55329; File No. SR-NASDAQ-2007-008]

Self-Regulatory Organizations; The NASDAQ Stock Market LLC;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change To
Clarify Opening Process for Nasdaq Market Center

February 21, 2007.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on February 12, 2007, The NASDAQ Stock Market LLC (``Nasdaq''), filed
with the Securities and Exchange Commission (``Commission'') the
proposed rule change as described in Items I and II below, which Items
have been prepared substantially by Nasdaq. The Exchange filed the
proposal as a ``non-controversial'' proposed rule change pursuant to
Section 19(b)(3)(A) of the Act,\3\ and Rule 19b-4(f)(6) thereunder,\4\
which renders the proposal effective upon filing with the
Commission.\5\ The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A).
    \4\ 17 CFR 240.19b-4(f)(6).
    \5\ Nasdaq has requested that the Commission waive the 5-day
written notice of intention to file the proposed rule change. In
addition, Nasdaq has asked the Commission to waive the 30-day
operative delay. See Rule 19b-4(f)(6)(iii). 17 CFR 240.19b-
4(f)(6)(iii).
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I. Self-Regulatory Organization's Statement of the Terms of the
Substance of the Proposed Rule Change

    Nasdaq is proposing to modify Rule 4752 to clarify that in the
Nasdaq Market Center (``System''), securities listed on the New York
and American Stock Exchanges, which are not subject to an opening
cross, open for the pre-market session in the same manner as Nasdaq-
listed securities. The text of the proposed rule change is available at
Nasdaq, the Commission's Public Reference Room, and http://www.nasdaq.complinet.com/nasdaq/display/index.html
.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for the Proposed Rule Change

    In its filing with the Commission, Nasdaq included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. Nasdaq has prepared summaries, set forth in Sections A,
B, and C below, of the most significant aspects of such statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    Nasdaq is proposing to modify Rule 4752 to clarify that in the
Nasdaq Market Center (``System''), securities listed on the New York
and American Stock Exchanges, which are not subject to an opening
cross, open for the pre-market session in the same manner as Nasdaq-
listed securities. Specifically, at 7 a.m., the System adds to the
Nasdaq book in time priority all eligible orders in accordance with
each order's defined characteristics. At 9:25 a.m., the System opens
all remaining unopened Quotes in accordance with each firm's
instructions. As with Nasdaq securities, market participants quoting in
NYSE/

Amex securities may instruct Nasdaq to open their quotes either at the
price of the firm's quote when the quote was closed by the participant
during the previous trading day or at a price and size entered by the
participant between 7 a.m. and 9:24:59 a.m.
    This opening process is consistent with the opening process for
NYSE/Amex securities that was utilized for such securities in Nasdaq's
ITS/CAES system pursuant to NASD Rule 4707(d) with the exception that
the NMC System opens at 7 a.m. rather than 7:30 a.m.
2. Statutory Basis
    Nasdaq believes that the proposed rule change is consistent with
the provisions of Section 6 of the Act,\6\ in general, and with Section
6(b)(5) of the Act,\7\ in particular, in that the proposal is designed
to prevent fraudulent and manipulative acts and practices, to promote
just and equitable principles of trade, to foster cooperation and
coordination with persons engaged in regulating, clearing, settling,
processing information with respect to, and facilitating 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 proposed rule change
clarifies certain terms in Nasdaq's rules.
---------------------------------------------------------------------------

    \6\ 15 U.S.C. 78f.
    \7\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

B. Self-Regulatory Organization's Statement on Burden on Competition

    Nasdaq does not believe that the proposed rule change will result
in any burden on competition that is not necessary or appropriate in
furtherance of the purposes of the Act, as amended.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    Written comments were neither solicited nor received.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    Because the foregoing rule change does not: (i) Significantly
affect the protection of investors or the public interest; (ii) impose
any significant burden on competition; and (iii) become operative for
30 days after the date of the filing, or such shorter time as the
Commission may designate, it has become effective pursuant to Section
19(b)(3)(A) of the Act \8\ and Rule 19b-4(f)(6) thereunder.\9\
---------------------------------------------------------------------------

    \8\ 15 U.S.C. 78s(b)(3)(A).
    \9\ 17 CFR 240.19b-4(f)(6).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of such proposed rule
change, the Commission may summarily abrogate the rule change if it
appears to the Commission that such action is necessary or appropriate
in the public interest, for the protection of investors, or otherwise
in furtherance of the purposes of the Act.
    A proposed rule change filed under Section 19b-4 of the Act
normally does not become operative prior to 30 days after the date of
the filing.\10\ However, Rule 19b-4(f)(6)(iii) permits the Commission
to designate a shorter time if such action is consistent with the
protection of investors and the public interest. Nasdaq has requested
that the Commission waive the 30-day operative delay contained in Rule
19b-4(f)(6)(iii) under the Act.\11\ Because the filing would conform
the opening of trading in NYSE/Amex securities to the opening of
trading in Nasdaq securities, thus streamlining the Nasdaq's opening
process, the Commission believes waiver of the 30-day operative delay
is consistent with the protection of investors and the public interest.
Accordingly, the Commission designates the proposal to be effective and
operative upon filing with the Commission.\12\
---------------------------------------------------------------------------

    \10\ 17 CFR 240.19b-4(f)(6)(iii). In addition, Rule 19b-
4(f)(6)(iii) requires that a self-regulatory organization submit to
the Commission written notice of its intent to file the proposed
rule change, along with a brief description and text of the proposed
rule change, at least five business days prior to the filing of the
proposed rule change, or such shorter time as designated by the
Commission. The Commission has decided to waive the five-day pre-
filing notice requirement.
    \11\ Id.
    \12\ For purposes only of waiving the 30-day operative delay of
this proposal, the Commission has considered the proposed rule's
impact on efficiency, competition, and capital formation. 15 U.S.C.
78C(F).
---------------------------------------------------------------------------

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml.
); or     Send an e-mail to<EMAIL_ADDRESS>Please include

File Number SR-NASDAQ-2007-008 in the subject line.

Paper Comments

     Send paper comments in triplicate to Nancy M. Morris,
Secretary, Securities and Exchange Commission, 100 F Street, NE.,
Washington, DC 20549-1090.

All submissions should refer to File Number SR-NASDAQ-2007-008. This
file number should be included on the subject line if e-mail is used.
To help the Commission process and review your comments more
efficiently, please use only one method. The Commission will post all
comments on the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml
). Copies of the submission, all subsequent amendments,

all written statements with respect to the proposed rule change that
are filed with the Commission, and all written communications relating
to the proposed rule change between the Commission and any person,
other than those that may be withheld from the public in accordance
with the provisions of 5 U.S.C. 552, will be available for inspection
and copying in the Commission's Public Reference Room. Copies of such
filing also will be available for inspection and copying at the
principal office of Nasdaq. All comments received will be posted
without change; the Commission does not edit personal identifying
information from submissions. You should submit only information that
you wish to make available publicly.
    All submissions should refer to File Number SR-NASDAQ-2007-008 and
should be submitted on or before March 21, 2007.

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\13\
---------------------------------------------------------------------------

    \13\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Florence E. Harmon,
Deputy Secretary.
[FR Doc. E7-3493 Filed 2-27-07; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 79, Number 73 (Wednesday, April 16, 2014)]
[Notices]
[Pages 21506-21507]
[FR Doc No: 2014-08637]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2011-0141]

Unified Carrier Registration Plan Board of Directors; Request for
Nominations

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

ACTION: Notice Requesting Nominations From Among Chief Administrative
Officers of State Agencies to the Board of Directors.

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SUMMARY: The FMCSA solicits nominations and applications for
appointment to the Board of Directors of the Unified Carrier
Registration Plan (UCR Plan) of interested persons to serve as
representatives of chief administrative officers of State agencies
responsible for overseeing the Unified Carrier Registration Agreement
(UCR Agreement). The Agency will appoint four members from such State
agencies, one from each of FMCSA's four service areas. As authorized by
49 U.S.C. 14504a, the UCR Plan is responsible for the administration of
the UCR Agreement. The UCR Agreement governs the registration and the
collection and distribution of fees paid by for-hire and private motor
carriers, brokers, freight forwarders, and leasing companies. The UCR
Plan and Agreement replaced the Single State Registration System
(SSRS), which was repealed as of January 1, 2008.

DATES: Nominations or expressions of interest for appointment to the
Board of Directors must be received on or before May 1, 2014.

ADDRESSES: You may submit comments to this notice, identified by docket
number FMCSA-2011-0141, by any of the following methods--Internet,
facsimile, regular mail, or hand-delivery.
    Federal eRulemaking Portal: Federal Docket Management System (FDMS)
Web site at http://www.regulations.gov. The FDMS is the preferred
method for submitting comments, and we urge you to use it. In the
``Comment'' or ``Submission'' section, type Docket ID Number ``FMCSA-
2011-0141'', select ``Go'', and then click on ``Send a Comment or
Submission.'' You will receive a tracking number when you submit a
comment.
    Fax: 1-202-493-2251.
    Mail, Courier, or Hand-Deliver: U.S. Department of Transportation,
Docket Operations (M-30), West Building Ground Floor, Room W12-140,
1200 New Jersey Avenue SE., Washington, DC 20590. Office hours are
between 9 a.m. and 5 p.m., ET, Monday through Friday, except Federal
holidays.
    Docket: Comments and material received from the public, as well as
background information and documents mentioned in this preamble, are
part of docket FMCSA--2011 -0141, and are available for inspection and
copying on the Internet at http://www.regulations.gov. You may also
view and copy documents at the U.S.

Department of Transportation's Docket Operations Unit, West Building
Ground Floor, Room W12-140, 1200 New Jersey Avenue SE., Washington, DC.
    Privacy Act: All comments will be posted without change including
any personal information provided to the FDMS at http://www.regulations.gov. Anyone can search the electronic form of all our
dockets in FDMS, by the name of the individual submitting the comment
(or signing the comment, if submitted on behalf of an association,
business, labor union, etc.). The Department of Transportation's (DOT)
complete Privacy Act Systems of Records notice was published in the
Federal Register on April 11, 2000 (65 FR 19476), and can be viewed at
http://docketsinfo.dot.gov. Comments received after the comment closing
date will be included in the docket, and we will consider late comments
to the extent practicable.

FOR FURTHER INFORMATION CONTACT: Mr. Gerald Folsom, Office of Research
and Information Technology,<PHONE_NUMBER>, FMCSA, Department of
Transportation, 1200 New Jersey Ave. SE., Washington, DC 20590 or by
email at<EMAIL_ADDRESS>
Background

    Section 4305(b) of the Safe, Accountable, Flexible, Efficient
Transportation Equity Act: A Legacy for Users (SAFETEA-LU) [Pub. L.
109-59, 119 Stat. 1144, August 10, 2005] enacted 49 U.S.C. 14504a
entitled ``Unified carrier registration system plan and agreement.''
Under the UCR Agreement, motor carriers, motor private carriers,
brokers, freight forwarders, and leasing companies that are involved in
interstate transportation register and pay certain fees. The UCR Plan's
Board of Directors must issue rules and regulations to govern the UCR
Agreement. Section 14504a(a)(9) defines the Unified Carrier
Registration Plan as the organization of State, Federal, and industry
representatives responsible for developing, implementing, and
administering the UCRA. Section 14504a(d)(1)(B) directed the Secretary
to establish a Unified Carrier Registration Plan Board of Directors
made up of 15 members from FMCSA, State governments, and the motor
carrier industry. The Board also must recommend initial annual fees to
be assessed against carriers, leasing companies, brokers, and freight
forwarders under the UCRA, as well as any annual adjustments to those
fees. Section 14504a(d)(1)(B) provides that the UCR Plan's Board of
Directors must consist of directors from the following groups:
    Federal Motor Carrier Safety Administration: One director must be
selected from each of the FMCSA four service areas (as defined by FMCSA
on January 1, 2005) from among the chief administrative officers of the
State agencies responsible for administering the UCRA.
    State Agencies: The five directors selected to represent State
agencies must be from among the professional staffs of State agencies
responsible for overseeing the administration of the UCR Agreement.
    Motor Carrier Industry: Five directors must be from the motor
carrier industry. At least one of the five motor carrier industry
directors must be from ``a national trade association representing the
general motor carrier of property industry'' and one of them must be
from ``a motor carrier that falls within the smallest fleet fee
bracket.''
    U.S. Department of Transportation (the Department): One individual,
either the FMCSA Deputy Administrator or such other Presidential
appointee from the Department appointed by the Secretary, represents
the Department.
    The establishment of the Board was announced in the Federal
Register on May 12, 2006 (71 FR 27777). In that notice, the Agency
recognized the American Trucking Associations, Inc. (ATA) as the
national trade association representing the general motor carrier of
property industry. ATA is a national affiliation of State trucking
organizations representing the national, State and local interests of
the 50 affiliated State trucking associations; and the interests of
specialized areas of the trucking industry through conferences and
councils. The Agency selected the Owner-Operator Independent Drivers
Association (OOIDA) as the organization from which to appoint an
individual to represent motor carriers comprising the smallest fleet
fee bracket. OOIDA is a national trade association representing the
interests of small trucking companies and drivers.
    Each of the four current directors from the chief administrative
officers of the State agencies responsible for overseeing the
administration of the UCR Agreement are serving terms that expire on
May 31, 2013. These directors may continue to serve until their
replacements are appointed; each of them may be reappointed (49 U.S.C.
14504a(d)(1)(D)(iii) and (iv)). Today's publication serves as a notice
requesting nominations for and public comment on possible appointment
of the four members of the UCR Plan's Board of Directors to be
appointed from the chief administrative officers of the responsible
State agencies in accordance with 49 U.S.C. 14504a(d).

Board Member Nominations

    FMCSA seeks either nominations of, or expressions of interest from,
individuals to serve as members of the board of directors for the UCR
Plan from the responsible State agencies. Nominations or expressions of
interest should indicate that the person nominated or recommended meets
the statutory requirements specified in 49 U.S.C. 14504a(d)(1)(B)(i).
    Nominations or expressions of interest must be transmitted by means
of the procedures for comments specified earlier in this notice. FMCSA
and the Department will make the appointments for the four members from
the responsible State agencies for three-year terms, expiring on May
31, 2017.

    Issued under the authority delegated in 49 CFR 1.87: March 18,
2014.
G. Kelly Leone,
Associate Administrator, Office of Research and Information Technology
and Chief Information Officer.
[FR Doc. 2014-08637 Filed 4-15-14; 8:45 am]
BILLING CODE 4910-EX-P


[Federal Register Volume 87, Number 108 (Monday, June 6, 2022)]
[Rules and Regulations]
[Pages 34203-34206]
[FR Doc No: 2022-11993]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2021-0400; FRL-9849-01-OCSPP]

Picarbutrazox; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

DATES: This regulation is effective June 6, 2022. Objections and
requests for hearings must be received on or before August 5, 2022and
must be filed in accordance with the instructions provided in 40 CFR
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2021-0400, is available at
https://www.regulations.gov or at the Office of Pesticide Programs
Regulatory Public Docket (OPP Docket) in the Environmental Protection
Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg.,
Rm. 3334, 1301 Constitution Ave. NW, Washington, DC 20460-0001. The
Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room and the OPP Docket is<PHONE_NUMBER>. For the latest
status information on EPA/DC services, docket access, visit https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Marietta Echeverria, Registration
Division (7505T), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001; main telephone number:<PHONE_NUMBER>; email address:
[email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

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

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

    You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Office of the
Federal Register's e-CFR site at https://www.ecfr.gov/current/title-40.

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-2021-0400 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
August 5, 2022. Addresses for mail and hand delivery of objections and
hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2021-0400 by one of
the following methods:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at https://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at https://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of August 24, 2021 (83 FR 47275) (FRL-8792-
02), EPA issued a document pursuant to FFDCA section 408(d)(3), 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
#1F8917) by Syngenta Crop Protection, LLC, 410 Swing Road, P.O. Box
18300, Greensboro, NC 27410-8300. The petition requested that 40 CFR
180.718(a) be amended by establishing tolerances for residues of the
fungicide picarbutrazox, (1,1-dimethylethyl N-[6-[[[(Z)-[(1-methyl-1H-
tetrazol-5-yl)phenylmethylene]amino]oxy]methyl]-2-pyridinyl]carbamate,
in or on the following raw agricultural commodities: Barley, grain at
0.01 parts per million (ppm); Barley, hay at 0.01 ppm; Barley, straw at
0.01 ppm; Bean, forage at 0.01 ppm; Bean, hay at 0.01 ppm; Buckwheat,
forage at 0.01 ppm; Buckwheat, grain at 0.01 ppm; Buckwheat, hay at
0.01 ppm; Buckwheat, straw at 0.01 ppm; Cotton at 0.01 ppm; Cotton, gin
byproducts at 0.01 ppm; Cotton, undelinted seed at 0.01 ppm; Herb group
25 at 0.01 ppm; Millet, pearl, forage at 0.01 ppm; Millet, pearl, grain
at 0.01 ppm; Millet, pearl, hay at 0.01 ppm; Millet, pearl, straw at

0.01 ppm; Millet, proso, forage at 0.01 ppm; Millet, proso, grain at
0.01 ppm; Millet, proso, hay at 0.01 ppm; Millet, proso, straw at 0.01
ppm; Oat, forage at 0.01 ppm; Oat, hay at 0.01 ppm; Oat, straw at 0.01
ppm; Oat, grain at 0.01 ppm; Pea, hay at 0.01 ppm; Pea, vines at 0.01
ppm; Rapeseed subgroup 20A at 0.01 ppm; Rye, forage at 0.01 ppm; Rye,
grain at 0.01 ppm; Rye, hay at 0.01 ppm; Rye, straw at 0.01 ppm;
Sorghum at 0.01 ppm; Spice group 26 at 0.01 ppm; Spinach at 0.01 ppm;
Teosinte, forage at 0.01 ppm; Teosinte, grain at 0.01 ppm; Teosinte,
hay at 0.01 ppm; Teosinte, straw at 0.01 ppm; Triticale, forage at 0.01
ppm; Triticale, grain at 0.01 ppm; Triticale, hay at 0.01 ppm;
Triticale, straw at 0.01 ppm; Vegetable, brassica, head and stem, group
5-16 at 0.01 ppm; Vegetable, bulb, group 3-07 at 0.01 ppm; Vegetable,
cucurbit, group 9 at 0.01 ppm; Vegetable, leafy, group 4-16, except
spinach at 0.01 ppm; Vegetable, leaves of root and tuber, group 2 at
0.01 ppm; Vegetable, legume, group 6 at 0.01 ppm; Vegetable, fruiting,
group 8-10 at 0.01 ppm; Vegetable, root and tuber, group 1, except
potato at 0.01 ppm; Vegetable, stalk, stem, and leaf petiole group 22
at 0.01 ppm; Wheat, forage at 0.01 ppm; Wheat, grain at 0.01 ppm;
Wheat, hay at 0.01 ppm; and Wheat, straw at 0.01 ppm. The August 24,
2021, notice of filing referenced a summary of the petition prepared by
Syngenta Crop Protection, LLC, the registrant, which is available in
the docket, https://www.regulations.gov. The only comment received on
the notice of filing was from the U.S. Department of Agriculture,
indicating support for the tolerance action.
    Based upon review of the data supporting the petition, EPA is
establishing tolerances in accordance with section 408(d)(4)(a)(i) of
the FFDCA.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. . .
.''
    Consistent with FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for picarbutrazox including
exposure resulting from the tolerances established by this action.
EPA's assessment of exposures and risks associated with picarbutrazox
follows.
    In an effort to streamline its publications in the Federal
Register, EPA is not reprinting sections that repeat what has been
previously published for tolerance rulemakings of the same pesticide
chemical. Where scientific information concerning a particular chemical
remains unchanged, the content of those sections would not vary between
tolerance rulemakings and republishing the same sections is
unnecessary. EPA considers referral back to those sections as
sufficient to provide an explanation of the information EPA considered
in making its safety determination for the new rulemaking.
    EPA has previously published a tolerance rulemaking for
picarbutrazox, most recently on March 5, 2021, in which EPA concluded,
based on the available information, that there is a reasonable
certainty that no harm would result from aggregate exposure to
picarbutrazox and established tolerances for residues of that pesticide
chemical. EPA is incorporating previously published sections from the
March 5, 2021, rulemaking as described further in this rulemaking, as
they remain unchanged.

A. Toxicological Profile

    For a discussion of the Toxicological Profile of picarbutrazox, see
Unit III.A. of the March 5, 2021, rulemaking (86 FR 12829) (FRL-10019-
99).

B. Toxicological Points of Departure/Levels of Concern

    For a summary of the Toxicological Points of Departure/Levels of
Concern used for the safety assessment, see Unit III.B. of the March 5,
2021, rulemaking.

C. Exposure Assessment.

    Much of the exposure assessment remains the same, although updates
have occurred to accommodate exposures from the petitioned-for
tolerances. The updates are discussed in this section; for a
description of the rest of the EPA approach to and assumptions for the
exposure assessment, see Unit III.C. of the March 5, 2021, rulemaking.
    Dietary exposure from food and feed uses. EPA's dietary exposure
assessments have been updated to include the added exposure from the
seed treatment uses of picarbutrazox on many agricultural commodities.
In addition, the dietary exposure assessment was revised to reflect the
updated Dietary Exposure Evaluation Model that incorporates the What We
Eat in America (WWEIA) consumption data from 2005-2010. For the acute
dietary exposure assessment, no toxicological effects of concern
resulting from a 1-day or single exposure were identified; therefore,
this assessment is unnecessary. For the chronic dietary exposure
assessment, EPA used tolerance-level residues, 100 percent crop treated
(PCT), and default processing factors.
    Anticipated residue and percent crop treated (PCT) information. EPA
did not use anticipated residue and/or PCT information in the dietary
assessment for picarbutrazox. Tolerance level residues and/or 100 PCT
were assumed for all food commodities.
    Drinking water, non-occupational, and cumulative exposures.
Drinking water exposures and residential (non-occupational) exposures
are not impacted by the added seed treatment uses in this action. Since
the last assessment in March 2021, the turf application rate has
increased (from 0.33 lb picarbutrazox/acre to 0.44 lb picarbutrazox/
acre), resulting in updated estimated drinking water concentrations
(EDWCs). The most recent dietary risk assessment used the updated
surface water EDWC of 2.33 ppb, which was calculated with the Pesticide
in Water Calculator (PWC) ver. 2.001. Despite the increased turf
application rate, the EDWC decreased from the March 2021 rule, which
used a turf surface water EDWC of 2.56 ppb. The decreased EDWC is due
to use of new weather data in the turf modeling scenario.
    Picarbutrazox is currently registered for use on turf that could
result in residential exposures. The residential risk estimate that was
used in the aggregate assessment is incidental oral hand-to-mouth post-
application exposure to treated turf/lawns for children aged 1 to less
than 2 years old. The Agency would like to note that the March 2021
rule inaccurately described intermediate-term aggregate exposure. The
only exposure, or risk assessed, for

residential post-application exposures in the March 2021 rule was for
incidental oral scenarios for children 1 to <2 years old, which is a
short-term exposure. Intermediate-term exposure is not anticipated when
assessing incidental oral exposures.
    EPA's conclusions concerning cumulative risk remain unchanged from
the March 5, 2021, rulemaking.

D. Safety Factor for Infants and Children

    EPA continues to conclude that there is reliable data to support
the reduction of the Food Quality Protection Act (FQPA) safety factor
to 1x. See Unit III.D. of the March 5, 2021, rulemaking for a
discussion of the Agency's rationale for that determination.

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
acute population adjusted dose (aPAD) and chronic population adjusted
dose (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 points of departure to ensure that an adequate
margin of exposure (MOE) exists.
    Picarbutrazox is not expected to pose an acute dietary risk, as no
adverse effect from a single dose exposure was identified and no acute
dietary endpoint was selected. Chronic dietary risks are below the
Agency's level of concern of 100% of the cPAD; they are <1% of the cPAD
for all infants (<1 year old), the population group receiving the
greatest exposure.
    The Agency analyzed short-term aggregate risk by aggregating
chronic dietary (food and drinking water) exposure to children 1 to <2
years old with incidental oral hand-to-mouth post-application exposure
to children 1 to <2 years old on treated turf. EPA has concluded the
combined short-term food, water, and residential exposures result in an
aggregate MOE of 920 for children 1 to <2 years old. Because EPA's
level of concern for picarbutrazox is an MOE of 30 or below, these MOEs
are not of concern.
    Based on the lack of chronic risk, EPA concludes that aggregate
exposure to picarbutrazox will not pose a cancer risk to humans.
    Therefore, based on these risk assessments and information
described above, 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 picarbutrazox residues. More
detailed information can be found at https://www.regulations.gov in the
document titled ``Picarbutrazox. Human Health Risk Assessment for the
Proposed Section 3 Registration to Expand Seed Treatment Use for
Several Agricultural Crops'' in docket ID number EPA-HQ-OPP-2021-0400.

IV. Other Considerations

A. Analytical Enforcement Methodology

    For a discussion of the available analytical enforcement method,
see Unit IV.A. of the March 5, 2021, rulemaking.

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 has not established an MRL for picarbutrazox.

C. Revisions to Petitioned-For Tolerances

    EPA is establishing tolerances for three crop groups: (1)
vegetable, foliage of legume, group 7; (2) grain, cereal, except rice,
group 15; and (3) grain, cereal, forage, fodder and straw, group 16.
EPA is not establishing tolerances for individual commodities included
in the petition. For example, EPA is establishing a tolerance for
grain, cereal, except rice, group 15 rather than establishing
tolerances for the individual commodities barley, grain; buckwheat,
grain; oat, grain; pearl millet, grain; proso millet, grain; rye,
grain; sorghum; teosinte, grain; triticale, grain; and wheat, grain.
    EPA is not establishing a tolerance for cotton as requested because
cotton is already established under the tolerance for cotton,
undelinted seed. EPA is establishing tolerances for vegetable, root,
subgroup 1A and vegetable, tuberous and corm, except potato, subgroup
1D rather than the petitioned-for tolerance for root and tuber
vegetables, except potato, crop group 1. Because data on potato was not
provided, EPA is establishing tolerances for subgroups 1A and 1D, which
do not require potato representative commodity data. All commodities in
group 1, except potato, are covered by establishing tolerances on those
two subgroups, so EPA is establishing tolerances substantively
consistent with what the petition requested.
    EPA is also correcting the definitions of the following commodities
to conform with EPA's Food and Feed Commodity Vocabulary. The commodity
definition for herb crop group 25 is revised to herb group 25. The
commodity definition for rapeseed (including canola) subgroup 20A is
revised to rapeseed subgroup 20A. The commodity definition for spice
crop group 26 is revised to spice group 26. The commodity definition
for brassica head and stem vegetables crop group 5-16 is revised to
vegetable, Brassica, head and stem, group 5-16. The commodity
definition for bulb vegetable group crop group 3-07 is revised to
vegetable, bulb, group 3-07. The commodity definition for cucurbit
vegetables crop group 9 is revised to vegetable, cucurbit, group 9. The
commodity definition for fruiting vegetables crop group 8-10 is revised
to vegetable, fruiting, group 8-10. The commodity definition for leafy
vegetables crop group 4-16 is revised to vegetable, leafy, group 4-16.
The commodity definition for leaves of root and tuber vegetables crop
group 2 is revised to vegetable, leaves of root and tuber, group 2. The
commodity definitions for edible-podded legume vegetables crop subgroup
6A; succulent shelled pea and bean crop subgroup 6B; dried shelled pea
and bean except soybean, subgroup 6C are revised to vegetable, legume,
group 6. The commodity definition for stalk, stem, and leaf petiole
vegetable crop group 22 is revised to vegetable, stalk, stem, and leaf
petiole, group 22.
    Finally, EPA is removing the established tolerances of 0.01 ppm for
corn, field, forage; corn, field, grain; corn, field, stover; corn,
pop, grain; corn, pop, stover; corn, sweet, forage; corn, sweet, kernel
plus cob with husks removed; corn, sweet, stover; soybean, forage;
soybean, hay; and soybean, seed because these commodities are included
in vegetable, legume, group 6; vegetable, foliage of legume, group 7;
grain, cereal, except rice, group 15; or grain, cereal, forage, fodder,
and straw, group 16.

V. Conclusion

    Therefore, tolerances are established for residues of
picarbutrazox, (1,1-dimethylethyl N-[6-[[[(Z)-[(1-methyl-1H-tetrazol-5-
yl)phenylmethylene]amino]oxy]methyl]-2-pyridinyl]carbamate, in or on
cotton, gin byproducts at 0.01 ppm; cotton, undelinted seed at 0.01
ppm; grain, cereal, except rice, group 15 at 0.01 ppm; grain, cereal,
forage, fodder, and

straw, group 16 at 0.01 ppm; herb group 25 at 0.01 ppm; rapeseed
subgroup 20A at 0.01 ppm; spice group 26 at 0.01 ppm; vegetable,
Brassica, head and stem, group 5-16 at 0.01 ppm; vegetable, bulb, group
3-07 at 0.01 ppm; vegetable, cucurbit, group 9 at 0.01 ppm; vegetable,
foliage of legume, group 7 at 0.01 ppm; vegetable, fruiting, group 8-10
at 0.01 ppm; vegetable, leafy, group 4-16 at 0.01 ppm; vegetable,
leaves of root and tuber, group 2 at 0.01 ppm; vegetable, legume, group
6 at 0.01 ppm; vegetable, stalk, stem, and leaf petiole group 22 at
0.01 ppm; vegetable, root, subgroup 1A at 0.01 ppm; and vegetable,
tuberous and corm, except potato, subgroup 1D at 0.01 ppm.

VI. Statutory and Executive Order Reviews

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

VII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

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

    Dated: May 25, 2022.
Marietta Echeverria,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, for the reasons stated in the preamble, EPA is amending
40 CFR chapter I as follows:

PART 180--TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES
IN FOOD

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

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

0
2. In Sec.  180.718, revise Table 1 to Paragraph (a) to read as
follows:

Sec.  180.718  Picarbutrazox; tolerances for residues.

    (a) * * *

                        Table 1 to Paragraph (a)
------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
Cotton, gin byproducts..................................            0.01
Cotton, undelinted seed.................................            0.01
Grain, cereal, except rice, group 15....................            0.01
Grain, cereal, forage, fodder, and straw, group 16......            0.01
Herb group 25...........................................            0.01
Rapeseed subgroup 20A...................................            0.01
Spice group 26..........................................            0.01
Vegetable, Brassica, head and stem, group 5-16..........            0.01
Vegetable, bulb, group 3-07.............................            0.01
Vegetable, cucurbit, group 9............................            0.01
Vegetable, foliage of legume, group 7...................            0.01
Vegetable, fruiting, group 8-10.........................            0.01
Vegetable, leafy, group 4-16............................            0.01
Vegetable, leaves of root and tuber, group 2............            0.01
Vegetable, legume, group 6..............................            0.01
Vegetable, stalk, stem, and leaf petiole group 22.......            0.01
Vegetable, root, subgroup 1A............................            0.01
Vegetable, tuberous and corm, except potato, subgroup 1D            0.01
------------------------------------------------------------------------

* * * * *
[FR Doc. 2022-11993 Filed 6-3-22; 8:45 am]
BILLING CODE 6560-50-P