[Federal Register Volume 85, Number 128 (Thursday, July 2, 2020)]
[Notices]
[Pages 39925-39926]
[FR Doc No: 2020-14315]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID FEMA-2020-0002; Internal Agency Docket No. FEMA-B-2038]

Proposed Flood Hazard Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: Comments are requested on proposed flood hazard
determinations, which may include additions or modifications of any
Base Flood Elevation (BFE), base flood depth, Special Flood Hazard Area
(SFHA) boundary or zone designation, or regulatory floodway on the
Flood Insurance Rate Maps (FIRMs), and where applicable, in the
supporting Flood Insurance Study (FIS) reports for the communities
listed in the table below. The purpose of this notice is to seek
general information and comment regarding the preliminary FIRM, and
where applicable, the FIS report that the Federal Emergency Management
Agency (FEMA) has provided to the affected communities. The FIRM and
FIS report are the basis of the floodplain management measures that the
community is required either to adopt or to show evidence of having in
effect in order to qualify or remain qualified for participation in the
National Flood Insurance Program (NFIP). In addition, the FIRM and FIS
report, once effective, will be used by insurance agents and others to
calculate appropriate flood insurance premium rates for new buildings
and the contents of those buildings.

DATES: Comments are to be submitted on or before September 30, 2020.

ADDRESSES: The Preliminary FIRM, and where applicable, the FIS report
for each community are available for inspection at both the online
location https://www.fema.gov/preliminaryfloodhazarddata and the
respective Community Map Repository address listed in the tables below.
Additionally, the current effective FIRM and FIS report for each
community are accessible online through the FEMA Map Service Center at
https://msc.fema.gov for comparison.
    You may submit comments, identified by Docket No. FEMA-B-2038, to
Rick Sacbibit, Chief, Engineering Services Branch, Federal Insurance
and Mitigation Administration, FEMA, 400 C Street SW, Washington, DC
20472,<PHONE_NUMBER>, or (email<EMAIL_ADDRESS>
FOR FURTHER INFORMATION CONTACT: Rick Sacbibit, Chief, Engineering
Services Branch, Federal Insurance and Mitigation Administration, FEMA,
400 C Street SW, Washington, DC 20472,<PHONE_NUMBER>, or (email)
<EMAIL_ADDRESS>or visit the FEMA Mapping and Insurance
eXchange (FMIX) online at https://www.floodmaps.fema.gov/fhm/fmx_main.html.

SUPPLEMENTARY INFORMATION: FEMA proposes to make flood hazard
determinations for each community listed below, in accordance with
section 110 of the Flood Disaster Protection Act of 1973, 42 U.S.C.
4104, and 44 CFR 67.4(a).
    These proposed flood hazard determinations, together with the
floodplain management criteria required by 44 CFR 60.3, are the minimum
that are required. They should not be construed to mean that the
community must change any existing ordinances that are more stringent
in their floodplain management requirements. The community may at any
time enact stricter requirements of its own or pursuant to policies
established by other Federal, State, or regional entities. These flood
hazard determinations are used to meet the floodplain management
requirements of the NFIP and are used to calculate the appropriate
flood insurance premium rates for new buildings built after the FIRM
and FIS report become effective.
    The communities affected by the flood hazard determinations are
provided in the tables below. Any request for reconsideration of the
revised flood hazard information shown on the Preliminary FIRM and FIS
report that satisfies the data requirements outlined in 44 CFR 67.6(b)
is considered an appeal. Comments unrelated to the flood hazard
determinations also will be considered before the FIRM and FIS report
become effective.
    Use of a Scientific Resolution Panel (SRP) is available to
communities in support of the appeal resolution process. SRPs are
independent panels of experts in hydrology, hydraulics, and other
pertinent sciences established to review conflicting scientific and
technical data and provide recommendations for resolution. Use of the
SRP only may be exercised after FEMA and local communities have been
engaged in a collaborative consultation process for at least 60 days
without a mutually acceptable resolution of an appeal. Additional
information regarding the SRP process can be found online at https://www.floodsrp.org/pdfs/srp_overview.pdf.
    The watersheds and/or communities affected are listed in the tables
below. The Preliminary FIRM, and where applicable, FIS report for each
community are available for inspection at both the online location
https://www.fema.gov/preliminaryfloodhazarddata and the respective
Community Map Repository address listed in the tables. For communities
with multiple ongoing Preliminary studies, the studies can be
identified by the unique project number and Preliminary FIRM date
listed in the tables. Additionally, the current effective FIRM and FIS
report for each community are accessible online through the FEMA Map
Service Center at https://msc.fema.gov for comparison.
(Catalog of Federal Domestic Assistance No. 97.022, ``Flood
Insurance.'')

Michael M. Grimm,
Assistant Administrator for Risk Management, Department of Homeland
Security, Federal Emergency Management Agency.

------------------------------------------------------------------------
                                             Community map repository
               Community                             address
------------------------------------------------------------------------
             Kern County, California and Incorporated Areas
------------------------------------------------------------------------
        Project: 14-09-3094S Preliminary Date: November 15, 2019
------------------------------------------------------------------------
City of Bakersfield....................  Development Services, 1715
                                          Chester Avenue, Bakersfield,
                                          CA 93301.
Unincorporated Areas of Kern County....  Public Works Department, 2700 M
                                          Street, Suite 500,
                                          Bakersfield, CA 93301.
------------------------------------------------------------------------

              Herkimer County, New York (All Jurisdictions)
------------------------------------------------------------------------
 Project: 17-02-0791S Preliminary Dates: August 3, 2018 and December 13,
                                  2019
------------------------------------------------------------------------
City of Little Falls...................  Little Falls City Hall, 659
                                          East Main Street, Little
                                          Falls, NY 13365.
Town of Columbia.......................  Columbia Town Hall, 147
                                          Columbia Center Road, Ilion,
                                          NY 13357.
Town of Danube.........................  Danube Town Hall, 438 Creek
                                          Road, Little Falls, NY 13365.
Town of Fairfield......................  Fairfield Town Hall, 439 Kelly
                                          Road, Little Falls, NY 13365.
Town of Frankfort......................  Frankfort Town Hall, 201 3rd
                                          Avenue, Frankfort, NY 13340.
Town of German Flatts..................  German Flatts Town Hall, 66
                                          East Main Street, Mohawk, NY
                                          13407.
Town of Herkimer.......................  Herkimer Town Hall, 114 North
                                          Prospect Street, Herkimer, NY
                                          13350.
Town of Litchfield.....................  Litchfield Town Hall, 804
                                          Cedarville Road, Ilion, NY
                                          13357.
Town of Little Falls...................  Little Falls Town Hall, 478
                                          Flint Avenue Extension,
                                         Little Falls, NY 13365.
Town of Manheim........................  Manheim Town Hall, 6356 State
                                          Route 167, Dolgeville, NY
                                          13329.
Town of Newport........................  Newport Town Hall, 2788 Newport
                                          Road, Newport, NY 13416.
Town of Norway.........................  Norway Town Office, 3013
                                          Military Road, Newport, NY
                                          13416.
Town of Ohio...........................  Ohio Town Hall, 234 Nellis
                                          Road, Ohio, NY 13324.
Town of Russia.........................  Russia Town Hall, 8916 North
                                          Main Street, Poland, NY 13431.
Town of Salisbury......................  Salisbury Town Hall, 126 State
                                          Route 29A, Salisbury Center,
                                          NY 13454.
Town of Schuyler.......................  Schuyler Town Hall, 2090 State
                                          Route 5, Utica, NY 13502.
Town of Stark..........................  Stark Town Hall, 703 Elwood
                                          Road, Fort Plain, NY 13339.
Town of Warren.........................  Warren Town Hall, 383 Hogsback
                                          Road, Richfield Springs, NY
                                          13439.
Town of Webb...........................  Webb Town Hall, 183 Park
                                          Avenue, Old Forge, NY 13420.
Town of Winfield.......................  Winfield Town Hall, 306 Stone
                                          Road, West Winfield, NY
                                         13491.
Village of Cold Brook..................  Russia Town Hall, 8916 North
                                          Main Street, Poland, NY 13431.
Village of Dolgeville..................  Dolgeville Village Hall, 41
                                          North Main Street, Dolgeville,
                                          NY 13329.
Village of Frankfort...................  Frankfort Village Hall, 110
                                          Railroad Street, Suite 1,
                                          Frankfort, NY 13340.
Village of Herkimer....................  Herkimer Village Hall, 120
                                          Green Street, Herkimer, NY
                                          13350.
Village of Ilion.......................  Ilion Village Hall, 49 Morgan
                                          Street, Ilion, NY 13357.
Village of Middleville.................  Corey Hall, 3 South Main
                                          Street, Middleville, NY 13406.
Village of Mohawk......................  Mohawk Village Hall, 28
                                          Columbia Street, Mohawk, NY
                                          13407.
Village of Newport.....................  Newport Village Hall, 4
                                          Coventry Avenue, Yorkville, NY
                                          13495.
Village of Poland......................  Poland Village Hall, 9 Case
                                          Street, Poland, NY 13431.
Village of West Winfield...............  Bisby Hall, 179 South Street,
                                          West Winfield, NY 13491.
------------------------------------------------------------------------

[FR Doc. 2020-14315 Filed 7-1-20; 8:45 am]
BILLING CODE 9110-12-P


[Federal Register Volume 88, Number 244 (Thursday, December 21, 2023)]
[Notices]
[Pages 88401-88402]
[FR Doc No: 2023-28092]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-D-1136]

Development of Monoclonal Antibody Products Targeting SARS-CoV-2
for Emergency Use Authorization; Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance for industry entitled
``Development of Monoclonal Antibody Products Targeting SARS-CoV-2 for
Emergency Use Authorization.'' This guidance provides recommendations
to sponsors on the development of monoclonal antibody products
targeting SARS-CoV-2 intended for the prevention or treatment of COVID-
19, including addressing the impact of emerging variants. The
recommendations focus on the data and information that may be used to
support a request for emergency use authorization (EUA) under the
Federal Food, Drug, and Cosmetic Act (FD&C Act). This guidance
supersedes the guidance entitled ``Development of Monoclonal Antibody
Products Targeting SARS-CoV-2, Including Addressing the Impact of
Emerging Variants, During the COVID-19 Public Health Emergency'' issued
on February 22, 2021.

DATES: The announcement of the guidance is published in the Federal
Register on December 21, 2023.

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

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2020-D-1136 for ``Development of Monoclonal Antibody Products
Targeting SARS-CoV-2 for Emergency Use Authorization.'' Received
comments will be placed in the docket and, except for those submitted
as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see Sec.
10.115(g)(5) (21 CFR 10.115(g)(5))).
    Submit written requests for single copies of the guidance to the
Division of Drug Information, Center for Drug Evaluation and Research,
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale
Building,

4th Floor, Silver Spring, MD 20993-0002. Send one self-addressed
adhesive label to assist that office in processing your requests. See
the SUPPLEMENTARY INFORMATION section for electronic access to the
guidance document.

FOR FURTHER INFORMATION CONTACT: Maria Clary, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 4638, Silver Spring, MD 20993-0002, 240-
402-8615.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a final guidance for industry
entitled ``Development of Monoclonal Antibody Products Targeting SARS-
CoV-2 for Emergency Use Authorization.'' This guidance provides
recommendations to sponsors on the development of monoclonal antibody
products targeting SARS-CoV-2 intended for the prevention or treatment
of COVID-19. The recommendations focus on the data and information that
may be used to support a request for EUA under section 564 of the FD&C
Act (21 U.S.C. 360bbb-3). Specifically, the guidance discusses the
manufacturing, pharmacology/toxicology, virologic, and clinical
considerations to support EUA.
    This guidance supersedes the guidance for industry entitled
``Development of Monoclonal Antibody Products Targeting SARS-CoV-2,
Including Addressing the Impact of Emerging Variants, During the COVID-
19 Public Health Emergency,'' which was published in February 2021. FDA
issued the guidance to communicate its policy for the duration of the
COVID-19 public health emergency (PHE) declared by the Secretary of
Health and Human Services (HHS) on January 31, 2020, including any
renewals made by the HHS Secretary in accordance with section 319(a)(2)
of the Public Health Service Act (42 U.S.C. 247d(a)(2)). In the Federal
Register of March 13, 2023 (88 FR 15417), FDA listed certain guidance
documents that FDA was revising to continue in effect for 180 days
after the expiration of the COVID-19 PHE declaration, during which time
FDA planned to further revise the guidances. The February 2021 guidance
on development of monoclonal antibody products targeting SARS-CoV-2 is
included in this list.
    Although circumstances have improved, SARS-CoV-2 remains in broad
circulation throughout the United States. The virus has and continues
to evolve over time, and in certain instances, mutations in the virus
have greatly reduced the activity of monoclonal antibody therapies
available for the prevention or treatment of COVID-19, resulting in
vulnerable populations having limited preventative and therapeutic
options. FDA retains the ability to issue an EUA under section 564 of
the FD&C Act for products to treat or prevent COVID-19, so the
recommendations in this guidance are still pertinent (88 FR 16644).
This guidance is intended to remain in effect only for the duration of
the declaration by the Secretary of HHS under section 564 of the FD&C
Act effective March 27, 2020, that circumstances exist justifying the
authorization of emergency use of drugs and biological products during
the COVID-19 pandemic (85 FR 18250). In revising this guidance, FDA
considered comments received on the 2021 guidance as well as the
Agency's experience issuing COVID-19-related EUAs. In addition,
editorial changes were made to improve clarity.
    Given the need to ensure that sponsors are aware of our current
recommendations to facilitate timely development of monoclonal antibody
products targeting SARS-CoV-2, FDA is issuing this guidance for
immediate implementation without initially seeking prior comment
because the Agency has determined that prior public participation is
not feasible or appropriate (see Sec.  10.115(g)(2) and section
701(h)(1)(C)(i) of the FD&C Act (21 U.S.C. 371(h)(1)(C)(i))). This
guidance document is being implemented immediately, but it remains
subject to comment in accordance with the Agency's good guidance
practices (see Sec.  10.115(g)(3)).
    The guidance represents the current thinking of FDA on
``Development of Monoclonal Antibody Products Targeting SARS-CoV-2 for
Emergency Use Authorization.'' It does not establish any rights for any
person and is not binding on FDA or the public. You can use an
alternative approach if it satisfies the requirements of the applicable
statutes and regulations.

II. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. The
previously approved collections of information are subject to review by
the Office of Management and Budget (OMB) under the Paperwork Reduction
Act of 1995 (PRA) (44 U.S.C. 3501-3521). The collections of information
in 21 CFR part 314 pertaining to new drug applications have been
approved under 0910-0001. The collections of information pertaining to
EUA of medical products have been approved under OMB control number
0910-0595.

III. Electronic Access

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

    Dated: December 15, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-28092 Filed 12-20-23; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 81, Number 200 (Monday, October 17, 2016)]
[Rules and Regulations]
[Pages 71370-71371]
[FR Doc No: 2016-25002]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 870

[Docket No. FDA-2016-N-2766]

Medical Devices; Cardiovascular Devices; Classification of the
Apical Closure Device

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

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SUMMARY: The Food and Drug Administration (FDA) is classifying the
apical closure device into class II (special controls). The special
controls that will apply to the device are identified in this order and
will be part of the codified language for the apical closure device's
classification. The Agency is classifying the device into class II
(special controls) in order to provide a reasonable assurance of safety
and effectiveness of the device.

DATES: This order is effective October 17, 2016. The classification was
applicable on July 27, 2016.

FOR FURTHER INFORMATION CONTACT: Jennifer Piselli, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave. Bldg. 66, Rm. 1561, Silver Spring, MD, 20993-0002, 240-
402-6646<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    In accordance with section 513(f)(1) of the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) (21 U.S.C. 360c(f)(1)), devices that were
not in commercial distribution before May 28, 1976 (the date of
enactment of the Medical Device Amendments of 1976), generally referred
to as postamendments devices, are classified automatically by statute
into class III without any FDA rulemaking process. These devices remain
in class III and require premarket approval unless and until the device
is classified or reclassified into class I or II, or FDA issues an
order finding the device to be substantially equivalent, in accordance
with section 513(i), to a predicate device that does not require
premarket approval. The Agency determines whether new devices are
substantially equivalent to predicate devices by means of premarket
notification procedures in section 510(k) of the FD&C Act (21 U.S.C.
360(k)) and part 807 (21 CFR part 807) of the regulations.
    Section 513(f)(2) of the FD&C Act, as amended by section 607 of the
Food and Drug Administration Safety and Innovation Act (Pub. L. 112-
144), provides two procedures by which a person may request FDA to
classify a device under the criteria set forth in section 513(a)(1).
Under the first procedure, the person submits a premarket notification
under section 510(k) of the FD&C Act for a device that has not
previously been classified and, within 30 days of receiving an order
classifying the device into class III under section 513(f)(1) of the
FD&C Act, the person requests a classification under section 513(f)(2).
Under the second procedure, rather than first submitting a premarket
notification under section 510(k) of the FD&C Act and then a request
for classification under the first procedure, the person determines
that there is no legally marketed device upon which to base a
determination of substantial equivalence and requests a classification
under section 513(f)(2) of the FD&C Act. If the person submits a
request to classify the device under this second procedure, FDA may
decline to undertake the classification request if FDA identifies a
legally marketed device that could provide a reasonable basis for
review of substantial equivalence with the device or if FDA determines
that the device submitted is not of ``low-moderate risk'' or that
general controls would be inadequate to control the risks and special
controls to mitigate the risks cannot be developed.
    In response to a request to classify a device under either
procedure provided by section 513(f)(2) of the FD&C Act, FDA shall
classify the device by written order within 120 days. This
classification will be the initial classification of the device.
    On June 25, 2015, Micro Interventional Devices, Inc. submitted a
request for classification of the Permaseal Device under section
513(f)(2) of the FD&C Act.
    In accordance with section 513(f)(2) of the FD&C Act, FDA reviewed
the request in order to classify the device under the criteria for
classification set forth in section 513(a)(1). FDA classifies devices
into class II if general controls by themselves are insufficient to
provide reasonable assurance of safety and effectiveness, but there is
sufficient information to establish special controls to provide
reasonable assurance of the safety and effectiveness of the device for
its intended use. After review of the information submitted in the
request, FDA determined that the device can be classified into class II
with the establishment of special controls. FDA believes these special
controls, in addition to general controls, will provide reasonable
assurance of the safety and effectiveness of the device.
    Therefore, on July 27, 2016, FDA issued an order to the requestor
classifying the device into class II. FDA is codifying the
classification of the device by adding 21 CFR 870.4510.
    Following the effective date of this final classification order,
any firm submitting a premarket notification (510(k)) for an apical
closure device will need to comply with the special controls named in
this final administrative order.
    The device is assigned the generic name apical closure device, and
it is identified as a prescription device consisting of a delivery
system and implant component that is used for soft tissue approximation
of cardiac apical tissue during transcatheter valve replacement
procedures.
    FDA has identified the following risks to health associated
specifically with this type of device and the measures required to
mitigate these risks in table 1:

      Table 1--Apical Closure Device Risks and Mitigation Measures
------------------------------------------------------------------------
            Identified risk                     Mitigation measure
------------------------------------------------------------------------
Infection..............................  Sterilization Validation.
                                         Shelf Life Testing.
                                         Labeling.
Adverse Tissue Reaction................  Biocompatibility Evaluation.
                                         In vivo Performance Testing.
Bleeding...............................  Non-clinical Performance
                                          Testing.
    [ssquf] At ventricular puncture or   In vivo Performance Testing.
     anchor deployment sites.            Labeling.
Tissue Damage..........................  Non-clinical Performance
                                          Testing.
    [ssquf] Apical tearing.............  In vivo Performance Testing.
    [ssquf] Myocardial tearing (local    Labeling.
     or diffuse).                        Training.
New Hypokinesia or Akinesis of Apex....  In vivo Performance Testing.
                                         Labeling.
Thromboemboli and Full Thickness Injury  In vivo Performance Testing.
                                         Labeling.
                                         Training.
Pericardial Tamponade..................  In vivo Performance Testing.
                                         Labeling.
------------------------------------------------------------------------

    FDA believes that special controls, in combination with the general
controls, address these risks to health and provide reasonable
assurance of the safety and effectiveness.
    Apical closure devices are not safe for use except under the
supervision of a practitioner licensed by law to direct the use of the
device. As such, the device is a prescription device and must satisfy
prescription labeling requirements (see 21 CFR 801.109 Prescription
devices).
    Section 510(m) of the FD&C Act provides that FDA may exempt a class
II device from the premarket notification requirements under section
510(k), if FDA determines that premarket notification is not necessary
to provide reasonable assurance of the safety and effectiveness of the
device. For this type of device, FDA has determined that premarket
notification is necessary to provide reasonable assurance of the safety
and effectiveness of the device. Therefore, this device type is not
exempt from premarket notification requirements. Persons who intend to
market this type of device must submit to FDA a premarket notification,
prior to marketing the device, which contains information about the
apical closure device they intend to market.

II. Analysis of Environmental Impact

    The Agency has determined under 21 CFR 25.34(b) that this action is
of a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.

III. Paperwork Reduction Act of 1995

    This final administrative order establishes special controls that
refer to previously approved collections of information found in other
FDA regulations. These collections of information are subject to review
by the Office of Management and Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of
information in part 807, subpart E, regarding premarket notification
submissions have been approved under OMB control number 0910-0120, and
the collections of information in 21 CFR part 801, regarding labeling
have been approved under OMB control number 0910-0485.

List of Subjects in 21 CFR Part 870

    Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
870 is amended as follows:

PART 870--CARDIOVASCULAR DEVICES

0
1. The authority citation for part 870 is revised to read as follows:

    Authority:  21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

0
2. Add Sec.  870.4510 to subpart E to read as follows:

Sec.  870.4510  Apical closure device.

    (a) Identification. An apical closure device is a prescription
device consisting of a delivery system and implant component that is
used for soft tissue approximation of cardiac apical tissue during
transcatheter valve replacement procedures.
    (b) Classification. Class II (special controls). The special
controls for this device are:
    (1) The patient contacting materials must be evaluated to be
biocompatible.
    (2) Performance data must validate the sterility of the patient-
contacting components of the device.
    (3) Performance data must support the shelf life of the device by
demonstrating continued sterility, package integrity, and device
functionality over the labeled shelf life.
    (4) Non-clinical performance testing data must demonstrate that the
device performs as intended under anticipated conditions of use. The
following performance characteristics must be tested:
    (i) Consistent and reliable implant deployment;
    (ii) Assessment of implant pull-out force; and
    (iii) Sheath size compatibility with implant.
    (5) In vivo evaluation of the device must demonstrate device
performance, including device operation resulting in closure of the
myocardial wound.
    (6) Labeling must include the following:
    (i) Detailed information explaining how the device operates;
    (ii) Sheath size that device can accommodate;
    (iii) Identification of the minimum myocardial wall thickness to
ensure optimal device function; and
    (iv) A shelf life.

    Dated: October 11, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-25002 Filed 10-14-16; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register: January 14, 2010 (Volume 75, Number 9)]
[Notices]
[Page 2153]
[DOCID:fr14ja10-82]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

[Docket No. USCG-2009-1071]

Certificate of Alternative Compliance for the Offshore Supply
Vessel C-CHARIOT

AGENCY: Coast Guard, DHS.

ACTION: Notice.

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SUMMARY: The Coast Guard announces that a Certificate of Alternative
Compliance was issued for the offshore supply vessel C-CHARIOT as
required by 33 U.S.C. 1605(c) and 33 CFR 81.18.

DATES: The Certificate of Alternative Compliance was issued on December
4, 2009.

ADDRESSES: The docket for this notice is available for inspection or
copying at the Docket Management Facility (M-30), U.S. Department of
Transportation, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays. You may also find this
docket on the Internet by going to http://www.regulations.gov,
inserting USCG-2009-1071 in the ``Keyword'' box, and then clicking on
``Search.''

FOR FURTHER INFORMATION CONTACT: If you have questions on this notice,
call CWO2 David Mauldin, District Eight, Prevention Branch, U.S. Coast
Guard, telephone<PHONE_NUMBER>. If you have questions on viewing or
submitting material to the docket, call Renee V. Wright, Program
Manager, Docket Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Background and Purpose

    The offshore supply vessel C-CHARIOT will be used for offshore
supply operations. The horizontal distance between the forward and aft
masthead lights may be 21'-8\3/4\''. Placing the aft masthead light at
the horizontal distance from the forward masthead light as required by
Annex I, paragraph 3(a) of the 72 COLREGS, and Annex I, Section
84.05(a) of the Inland Rules Act, would result in an aft masthead light
location directly over the cargo deck where it would interfere with
loading and unloading operations.
    The Certificate of Alternative Compliance allows for the horizontal
separation of the forward and aft masthead lights to deviate from the
requirements of Annex I, paragraph 3(a) of 72 COLREGS, and Annex I,
Section 84.05(a) of the Inland Rules Act.
    This notice is issued under authority of 33 U.S.C. 1605(c), and 33
CFR 81.18.

    Dated: December 14, 2009.
J.W. Johnson,
Commander, U.S. Coast Guard, Chief, Inspections and Investigations
Branch, By Direction of the Commander, Eighth Coast Guard District.
[FR Doc. 2010-549 Filed 1-13-10; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 81, Number 250 (Thursday, December 29, 2016)]
[Notices]
[Page 95977]
[FR Doc No: 2016-31537]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER17-582-000]

Westside Solar, LLC; Supplemental Notice That Initial Market-
Based Rate Filing Includes Request for Blanket Section 204
Authorization

    This is a supplemental notice in the above-referenced proceeding of
Westside Solar, LLC`s application for market-based rate authority, with
an accompanying rate tariff, noting that such application includes a
request for blanket authorization, under 18 CFR part 34, of future
issuances of securities and assumptions of liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street, NE.,
Washington, DC 20426, in accordance with Rules 211 and 214 of the
Commission's Rules of Practice and Procedure (18 CFR 385.211 and
385.214). Anyone filing a motion to intervene or protest must serve a
copy of that document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is January 11, 2017.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
5 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First Street NE., Washington, DC 20426.
    The filings in the above-referenced proceeding are accessible in
the Commission's eLibrary system by clicking on the appropriate link in
the above list. They are also available for electronic review in the
Commission's Public Reference Room in Washington, DC. There is an
eSubscription link on the Web site that enables subscribers to receive
email notification when a document is added to a subscribed docket(s).
For assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.

    Dated: December 22, 2016.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2016-31537 Filed 12-28-16; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register: July 30, 2008 (Volume 73, Number 147)]
[Rules and Regulations]
[Page 44164-44168]
[DOCID:fr30jy08-15]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2007-0214; FRL-8373-2]

Pyraclostrobin; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for combined residues
of pyraclostrobin and its desmethoxy metabolite in or on the following
commodities: Borage, seed; castor oil plant, seed; chinese tallowtree,
seed; crambe, seed; cuphea, seed; echium, seed; euphorbia, seed;
evening primrose, seed; flax, seed; gold of pleasure, seed; hare's ear
mustard, seed; jojoba, seed; lesquerella, seed; lunaria, seed;
meadowfoam, seed; milkweed, seed; mustard, seed; niger seed, seed; oil
radish, seed; poppy, seed; rapeseed, seed; rose hip, seed; safflower,
seed; sesame, seed; stokes aster, seed; sweet rocket, seed; tallowwood,
seed; tea oil plant, seed; and vernonia, seed. It also increases the
existing tolerance for residues of pyraclostrobin and its desmethoxy
metabolite in or on sunflower. BASF Corporation requested these
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective July 30, 2008. Objections and
requests for hearings must be received on or before September 29, 2008,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2007-0214. To access the
electronic docket, go to http://www.regulations.gov, select ``Advanced
Search,'' then ``Docket Search.'' Insert the docket ID number where
indicated and select the ``Submit'' button. Follow the instructions on
the regulations.gov website to view the docket index or access
available documents. All documents in the docket are listed in the
docket index available in regulations.gov. Although listed in the
index, some information is not publicly available, e.g., Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are

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

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

I. General Information

A. Does this Action Apply to Me?

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

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

    In addition to accessing an electronic copy of this Federal
Register document through the electronic docket at http://
www.regulations.gov, you may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr. You may also access a
frequently updated electronic version of EPA's tolerance regulations at
40 CFR part 180 through the Government Printing Office's pilot e-CFR
site at http://www.gpoaccess.gov/ecfr.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, any person may file an objection to
any aspect of this regulation and may also request a hearing on those
objections. You must file your objection or request a hearing on this
regulation in accordance with the instructions provided in 40 CFR part
178. To ensure proper receipt by EPA, you must identify docket ID
number EPA-HQ-OPP-2007-0214 in the subject line on the first page of
your submission. All requests must be in writing, and must be mailed or
delivered to the Hearing Clerk as required by 40 CFR part 178 on or
before September 29, 2008.
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit this copy, identified by docket ID number
EPA-HQ-OPP-2007-0214, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket's normal hours of operation (8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays). Special
arrangements should be made for deliveries of boxed information. The
Docket Facility telephone number is<PHONE_NUMBER>.

II. Petition for Tolerance

    In the Federal Register of June 13, 2008 (73 FR 33814) (FRL-8367-
3), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
6F7105) by BASF Corporation, 26 Davis Dr., Research Triangle Park, NC
27709. The petition requested that 40 CFR 180.582 be amended by
establishing tolerances for combined residues of the fungicide
pyraclostrobin; carbamic acid, [2-[[[1-(4-chlorophenyl)-1H-pyrazol-3-
yl]oxy]methyl]phenyl]methoxy-, methyl ester and its desmethoxy
metabolite; (methyl-N-[[[1-(4-chlorophenyl)-1H-pyrazol-3-
yl]oxy]methyl]phenylcarbamate, expressed as parent compound, in or on
borage; castor oil plant; chinese tallowtree; crambe; cuphea; echium;
euphorbia; evening primrose; flax seed; gold of pleasure; hare's ear
mustard; jojoba; lesquerella; lunaria; meadowfoam; milkweed; mustard
seed; niger seed; oil radish; poppy seed; rapeseed; rose hip;
safflower; sesame; stokes aster; sunflower; sweet rocket; tallowwood;
tea oil plant; and vernonia; each at 0.45 parts per million (ppm). That
notice referenced a summary of the petition prepared by BASF
Corporation, the registrant, which is available to the public in the
docket, http://www.regulations.gov. There were no comments received in
response to the notice of filing.
    No changes were made to the proposed tolerance levels; however, EPA
modified the proposed commodity terms slightly (e.g., changing
``borage'' to ``borage, seed'', ``cuphea'' to ``cuphea, seed'', etc.)
to conform to current nomenclature recommendations.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. . .
.''
    Consistent with section 408(b)(2)(D) of FFDCA, and the factors
specified in section 408(b)(2)(D) of FFDCA, EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has sufficient data to assess the hazards of and to
make a determination on aggregate exposure for the petitioned-for

tolerances for combined residues of pyraclostrobin and its desmethoxy
metabolite on borage, seed; castor oil plant, seed; chinese tallowtree,
seed; crambe, seed; cuphea, seed; echium, seed; euphorbia, seed;
evening primrose, seed; flax, seed; gold of pleasure, seed; hare's ear
mustard, seed; jojoba, seed; lesquerella, seed; lunaria, seed;
meadowfoam, seed; milkweed, seed; mustard, seed; niger seed, seed; oil
radish, seed; poppy, seed; rapeseed, seed; rose hip, seed; safflower,
seed; sesame, seed; stokes aster, seed; sunflower, seed; sweet rocket,
seed; tallowwood, seed; tea oil plant, seed; and vernonia, seed; each
at 0.45 ppm. EPA's assessment of exposures and risks associated with
establishing tolerances follows.
    On March 24, 2008 the Agency published a Final Rule (73 FR 15425,
FRL-8355-4) establishing tolerances for residues of pyraclostrobin and
its desmethoxy metabolite in or on avocado at 0.6 ppm; barley, grain at
1.4 ppm; canistel at 0.6 ppm; mango at 0.6 ppm; oat, grain at 1.2 ppm;
oat, hay at 18 ppm; oat, straw at 15 ppm; papaya at 0.6 ppm; sapodilla
at 0.6 ppm; sapote, black at 0.6 ppm; sapote, mamey at 0.6 ppm; and
star apple at 0.6 ppm. When the Agency conducted the risk assessments
in support of this tolerance action it assumed that pyraclostrobin
residues would be present on all of the oilseed commodities requested
in this petition as well as on all foods covered by the proposed and
established tolerances. Residues on oilseeds were included because
there was a pending petition for pyraclostrobin tolerances on oilseed
commodities at the time. The decision to establish tolerances on
oilseed commodities was deferred until now because the original notice
of filing of this petition contained errors requiring revision and re-
publication in the Federal Register. Since the oilseed commodities were
included in the previous risk assessments, establishing the oilseed
commodity tolerances will not change the most recent estimated
aggregate risks resulting from use of pyraclostrobin, as discussed in
the March 24, 2008 Federal Register. Refer to the March 24, 2008
Federal Register document, available at http://www.regulations.gov, for
a detailed discussion of the aggregate risk assessments and
determination of safety. EPA relies upon those risk assessments and the
findings made in the Federal Register document in support of this
action.
    Based on the risk assessments discussed in the final rule published
in the Federal Register of March 24, 2008 (73 FR 15425, FRL-8355-4),
EPA concludes that there is a reasonable certainty that no harm will
result to the general population, and to infants and children from
aggregate exposure to pyraclostrobin residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methods (an Liquid chromatography/mass/
spectrometry (LC/MS/MS) method (BASF Method D9808), and an high
performance liquid chromatography/ultraviolet (HPLC/UV) method (BASF
Method D9904)) are available to enforce the tolerance expression. The
methods may be requested from: Chief, Analytical Chemistry Branch,
Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350;
telephone number:<PHONE_NUMBER>; e-mail address:
<EMAIL_ADDRESS>
B. International Residue Limits

    No CODEX, Canadian or Mexican maximum residue limits (MRLs) have
been established for residues of pyraclostrobin on the oilseed
commodities associated with this petition.

V. Conclusion

    Therefore, tolerances are established for combined residues of
pyraclostrobin carbamic acid, [2-[[[1-(4-chlorophenyl)-1H-pyrazol-3-
yl]oxy]methyl]phenyl]methoxy-, methyl ester and its desmethoxy
metabolite; methyl-N-[[[1-(4-chlorophenyl)-1H-pyrazol-3-
yl]oxy]methyl]phenylcarbamate, expressed as parent compound, in or on
borage, seed; castor oil plant, seed; chinese tallowtree, seed; crambe,
seed; cuphea, seed; echium, seed; euphorbia, seed; evening primrose,
seed; flax, seed; gold of pleasure, seed; hare's ear mustard, seed;
jojoba, seed; lesquerella, seed; lunaria, seed; meadowfoam, seed;
milkweed, seed; mustard, seed; niger seed, seed; oil radish, seed;
poppy, seed; rapeseed, seed; rose hip, seed; safflower, seed; sesame,
seed; stokes aster, seed; sweet rocket, seed; tallowwood, seed; tea oil
plant, seed; and vernonia, seed; each at 0.45 ppm. The existing
tolerance for combined residues of pyraclostrobin and its desmethoxy
metabolite on sunflower at 0.3 ppm is revised to read ``sunflower,
seed'' at 0.45 ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under section 408(d) of
FFDCA in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). Because this final rule has been
exempted from review under Executive Order 12866, this final rule is
not subject to Executive Order 13211, Actions Concerning Regulations
That Significantly Affect Energy Supply, Distribution, or Use (66 FR
28355, May 22, 2001) or Executive Order 13045, entitled Protection of
Children from Environmental Health Risks and Safety Risks (62 FR 19885,
April 23, 1997). This final rule does not contain any information
collections subject to OMB approval under the Paperwork Reduction Act
(PRA), 44 U.S.C. 3501 et seq., nor does it require any special
considerations under Executive Order 12898, entitled Federal Actions to
Address Environmental Justice in Minority Populations and Low-Income
Populations (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under section 408(d) of FFDCA, such as the tolerance in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.
    This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled Federalism (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (65 FR
67249, November 9, 2000) do not apply to this final rule. In addition,
this final rule does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (Public Law 104-4).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995

(NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note).

VII. Congressional Review Act

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

List of Subjects in 40 CFR Part 180

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

    Dated: July 10, 2008.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

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

PART 180--[AMENDED]

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

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

0
2. Section 180.582 is amended by revising the entry for sunflower to
read sunflower, seed, and alphabetically adding the following
commodities to the table in paragraph (a)(1) to read as follows:

Sec.  180.582  Pyraclostrobin; tolerances for residues.

    (a) General. (1) * * *

------------------------------------------------------------------------
              Commodity                        Parts per million
------------------------------------------------------------------------
                                * * * * *
Borage, seed........................                                0.45
                                * * * * *
Castor oil plant, seed..............                                0.45
Chinese tallowtree, seed............                                0.45
                                * * * * *
Crambe, seed........................                                0.45
Cuphea, seed........................                                0.45
Echium, seed........................                                0.45
Euphorbia, seed.....................                                0.45
Evening primrose, seed..............                                0.45
Flax, seed..........................                                0.45
                                * * * * *
Gold of pleasure, seed..............                                0.45
                                * * * * *
Hare's ear mustard, seed............                                0.45
                                * * * * *
Jojoba, seed........................                                0.45
Lesquerella, seed...................                                0.45
Lunaria, seed.......................                                0.45
                                * * * * *
Meadowfoam, seed....................                                0.45
Milkweed, seed......................                                0.45
Mustard, seed.......................                                0.45
Niger seed, seed....................                                0.45
                                * * * * *
Oil radish, seed....................                                0.45
                                * * * * *
Poppy, seed.........................                                0.45
                                * * * * *
Rapeseed, seed......................                                0.45
Rose hip, seed......................                                0.45
                                * * * * *
Safflower, seed.....................                                0.45
                                * * * * *
Sesame, seed........................                                0.45
                                * * * * *
Stokes aster, seed..................                                0.45
                                * * * * *
Sunflower, seed.....................                                0.45
Sweet rocket, seed..................                                0.45
Tallowwood, seed....................                                0.45
Tea oil plant, seed.................                                0.45
                                * * * * *
Vernonia, seed......................                                0.45
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. E8-17480 Filed 7-29-08; 8:45 am]

BILLING CODE 6560-50-S


[Federal Register: July 24, 2009 (Volume 74, Number 141)]
[Notices]
[Page 36686-36687]
[DOCID:fr24jy09-55]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 13160-002]

Red River Hydro LLC; Notice of Intent To File License
Application, Filing of Pre-Application Document, Commencement of
Licensing Proceeding, and Scoping; Request for Comments on the Pad and
Scoping Document, and Identification of Issues and Associated Study
Requests

July 17, 2009.
    a. Type of Filing: Notice of Intent to File License Application for
a New License and Commencing Licensing Proceeding.
    b. Project No.: 13160-002.
    c. Dated Filed: July 16, 2009.
    d. Submitted by: Red River Hydro LLC.
    e. Name of Project: Overton Lock and Dam Hydroelectric Project.
    f. Location: On the Red River in Rapides Parish, Louisiana at the
U.S. Army Corps of Engineers' existing Overton Lock and Dam.
    g. Filed Pursuant to: 18 CFR Part 5 of the Commission's
Regulations.
    h. Potential Applicant Contact: Brent L. Smith, COO, Symbiotics
LLC, P.O. Box 535, Rigby, Idaho 83442,<PHONE_NUMBER> or e-mail at
<EMAIL_ADDRESS>    i. FERC Contact: Lesley Kordella at<PHONE_NUMBER> or e-mail at
<EMAIL_ADDRESS>    j. Cooperating agencies: Federal, state, local, and tribal agencies
with jurisdiction and/or special expertise with respect to
environmental issues that wish to cooperate in the preparation of the
environmental document should follow the instructions for filing such
requests described in item o below. Cooperating agencies should note
the Commission's policy that agencies that cooperate in the preparation
of the environmental document cannot also intervene. See, 94 FERC ]
61,076 (2001).
    k. With this notice, we are initiating informal consultation with:
(a) the U.S. Fish and Wildlife Service and/or NOAA Fisheries under
section 7 of the Endangered Species Act and the joint agency
regulations thereunder at 50 CFR, Part 402 and (b) the State Historic
Preservation Officer, as required by Section 106, National Historical
Preservation Act, and the implementing regulations of the Advisory
Council on Historic Preservation at 36 CFR 800.2.
    l. Red River Hydro LLC filed a Pre-Application Document (PAD;
including a proposed process plan and schedule) with the Commission,
pursuant to 18 CFR 5.6 of the Commission's regulations.
    m. A copy of the PAD is available for review at the Commission in
the Public Reference Room or may be viewed on the Commission's Web site
(http://www.ferc.gov), using the ``eLibrary'' link. Enter the docket
number, excluding the last three digits in the docket number field to
access the document. For assistance, contact FERC Online Support at
<EMAIL_ADDRESS>or toll free at 1-866-208-3676, of for TTY,
(202) 502-8659. A copy is also available for inspection and
reproduction at the address in paragraph h.
    Register online at http://www.ferc.gov/docs-filing/
esubscription.asp to be notified via e-mail of new filing and issuances
related to this or other pending projects. For assistance, contact FERC
Online Support.
    n. With this notice, we are soliciting comments on the PAD and
Scoping Document 1 (SD1), as well as study requests. All comments on
the PAD and SD1, and study requests should be sent to the address above
in paragraph h. In addition, all comments on the PAD and SD1, study
requests, requests for cooperating agency status, and all
communications to and from Commission staff related to the merits of
the potential application (original and eight copies) must be filed
with the Commission at the following address: Kimberly D. Bose,
Secretary, Federal Energy Regulatory Commission, 888 First Street, NE.,
Washington, DC 20426. All filings with the Commission must include on
the first page, the project name (Overton Lock and Dam Hydroelectric
Project) and number (P-13160-002), and bear the heading ``Comments on
Pre-Application Document,'' ``Study Requests,'' ``Comments on Scoping
Document 1,'' ``Request for Cooperating Agency Status,'' or
``Communications to and from Commission Staff.'' Any individual or
entity interested in submitting study requests, commenting on the PAD
or SD1, and any agency requesting cooperating status must do so by
September 15, 2009.
    Comments on the PAD and SD1, study requests, requests for
cooperating agency status, and other permissible forms of
communications with the Commission may be filed electronically via the
Internet in lieu of paper. The Commission strongly encourages
electronic filings. See 18 CFR 385.2001(a)(1)(iii) and the instructions
on the Commission's Web site (http://www.ferc.gov/docs-filing/
ferconline.asp)

under the ``e-filing'' link. For a simpler method of submitting text
only comments, click on ``Quick Comment.''
    p. Although our current intent is to prepare an environmental
assessment (EA), there is the possibility that an Environmental Impact
Statement (EIS) will be required. Nevertheless, this meeting will
satisfy the NEPA scoping requirements, irrespective of whether an EA or
EIS is issued by the Commission.

Scoping Meetings

    Commission staff will hold two scoping meetings in the vicinity of
the project at the time and place noted below. The daytime meeting will
focus on resource agency, Indian tribes, and non-governmental
organization concerns, while the evening meeting is primarily for
receiving input from the public. We invite all interested individuals,
organizations, and agencies to attend one or both of the meetings, and
to assist staff in identifying particular study needs, as well as the
scope of environmental issues to be addressed in the environmental
document. The times and locations of these meetings are as follows:

Daytime Scoping Meeting

    Date: Wednesday August 12, 2009.
    Time: 7 p.m.
    Location: Sai Convention Center, 2301 N. MacArthur Drive,
Alexandria, LA, 71301.
    Phone:<PHONE_NUMBER>.

Evening Scoping Meeting

    Date: Thursday August 13, 2009.
    Time: 10 a.m.
    Location: Sai Convention Center, 2301 N. MacArthur Drive,
Alexandria, LA, 71301.
    Phone:<PHONE_NUMBER>.
    Scoping Document 1 (SD1), which outlines the subject areas to be
addressed in the environmental document, was mailed to the individuals
and entities on the Commission's mailing list. Copies of SD1 will be
available at the scoping meetings, or may be viewed on the Web at
http://www.ferc.gov, using the ``eLibrary'' link. Follow the directions
for accessing information in paragraph n. Based on all oral and written
comments, a Scoping Document 2 (SD2) may be issued. SD2 may include a
revised process plan and schedule, as well as a list of issues,
identified through the scoping process.

Site Visit

    The potential applicant and Commission staff will conduct a site
visit of the project on Wednesday, August 12, 2009. Those wishing to
participate should meet at the John H. Overton Lock and Dam Recreation
Area (west) at 9 a.m. For directions, and to appropriately accommodate
persons interested in attending the site visit, participants should
contact Erik Steimle by August 6, 2009 [e-mail,
<EMAIL_ADDRESS>or phone,<PHONE_NUMBER>]. All
participants are responsible for their own transportation.

Meeting Objectives

    At the scoping meetings, staff will: (1) Initiate scoping of the
issues; (2) review and discuss existing conditions and resource
management objectives; (3) review and discuss existing information and
identify preliminary information and study needs; (4) review and
discuss the process plan and schedule for pre-filing activity that
incorporates the time frames provided for in Part 5 of the Commission's
regulations and, to the extent possible, maximizes coordination of
federal, state, and tribal permitting and certification processes; and
(5) discuss the appropriateness of any federal or state agency or
Indian tribe acting as a cooperating agency for development of an
environmental document.
    Meeting participants should come prepared to discuss their issues
and/or concerns. Please review the PAD in preparation for the scoping
meetings. Directions on how to obtain a copy of the PAD and SD1 are
included in item n. of this document.

Meeting Procedures

    The meetings will be recorded by a stenographer and will become
part of the formal record of the Commission proceeding on the project.

Kimberly D. Bose,
Secretary.
[FR Doc. E9-17693 Filed 7-23-09; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 77, Number 190 (Monday, October 1, 2012)]
[Notices]
[Pages 59998-60000]
[FR Doc No: 2012-24038]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-67921; File No. SR-OCC-2012-17]

Self-Regulatory Organizations; The Options Clearing Corporation;
Advance Notice Relating to the Margining of Segregated Futures Customer
Accounts on a Gross Basis

September 25, 2012.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'')\1\ and Rule 19b-4(n)(1)(i),\2\ notice is hereby given that on
September 14, 2012, The Options Clearing Corporation (``OCC'') filed
with the Securities and Exchange Commission (``Commission'') the
advance notice described in Items I and II below, which Items have been
prepared primarily by OCC. The Commission is publishing this notice to
solicit comments on the advance notice from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4(n)(i).
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I. Clearing Agency's Statement of the Terms of Substance of the Advance
Notice

    The proposed rule change would allow OCC to become compliant with
Commodity Futures Trading Commission (``CFTC'') Rule 39.13(g)(8)(i),
which requires the margining of segregated futures customer accounts on
a gross basis.

II. Clearing Agency's Statement of the Purpose of, and Statutory Basis
for, the Advance Notice

    In its filing with the Commission, the clearing agency included
statements concerning the purpose of and basis for the proposed rule
change and advance notice and discussed any comments it received on the
proposed rule change and advance notice. The text of these statements
may be examined at the places specified in Item IV below. The clearing
agency has prepared summaries, set forth in sections A, B and C below,
of the most significant aspects of such statements.\3\
---------------------------------------------------------------------------

    \3\ The Commission has modified the text of the summaries
prepared by OCC.
---------------------------------------------------------------------------

(A) Clearing Agency's Statement of the Purpose of, and Statutory Basis
for, the Advance Notice

    The purpose of this proposed rule change is to provide for the
margining of OCC segregated futures customer accounts on a gross basis,
as required by CFTC Rule 39.13(g)(8)(i).\4\
---------------------------------------------------------------------------

    \4\ 17 CFR 39.13(g)(8)(i).

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The CFTC's Customer Gross Margin Rule

    On October 18, 2011, the CFTC issued final regulations implementing
many of the new statutory core principles for CFTC-registered
derivatives clearing organizations (``DCOs'') enacted under the Dodd-
Frank Wall Street Reform and Consumer Protection Act (the ``Dodd-Frank
Act''). As a registered DCO (as well as a registered securities
clearing agency), OCC has previously implemented rule changes designed
to bring OCC into compliance with CFTC rules applicable to DCOs that
went into effect on January 9, 2012 \5\ and May 7, 2012.\6\ OCC
believes it is necessary to amend its Rules in order to ensure
compliance with the gross margin rule, which requires a DCO to
``collect initial margin on a gross basis for each clearing member's
customer account(s) equal to the sum of the initial margin amounts that
would be required by the derivatives clearing organization for each
individual customer within that account if each individual customer
were a clearing member.'' \7\ The CFTC gross margin rule goes into
effect on November 8, 2012; however, OCC intends to begin complying
with the gross margin rule on Monday November 5, 2012 as described
herein.
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    \5\ See SR-OCC-2011-18.
    \6\ See SR-OCC-2012-06.
    \7\ Derivatives Clearing Organization General Provisions and
Core Principles, 76 FR 69334, 69439 (November 8, 2011).
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OCC's System for Calculating Margin

    OCC currently calculates margin requirements for each clearing
member's segregated futures customer account held at OCC on a net basis
by applying OCC's System for Theoretical Analysis and Numerical
Simulations (``STANS''). STANS calculates margin with respect to each
account of a clearing member, including each clearing member's futures
customer account(s), on a net basis, i.e., considering the positions of
a clearing member, including positions held in each clearing member's
futures customer account(s), as if they are part of one portfolio and
margining accordingly. STANS includes both a net asset value (``NAV'')
component and a risk component. The NAV component marks all positions
to market and nets long and short positions to determine the NAV of
each clearing member's portfolio of customer positions. The NAV
component represents the cost to liquidate the portfolio at current
prices by selling the net long positions and buying in the net short
positions. The risk component is estimated by means of an expected
shortfall risk measure obtained from ``Monte Carlo'' simulations
designed to measure the additional asset value required in any
portfolio to eliminate an unacceptable level of risk that the portfolio
would liquidate to a deficit.
    OCC presently lacks sufficient information about individual
customer positions to calculate margin at the level of each individual
customer. However, OCC has been coordinating with other DCOs to
establish an industry-wide mechanism for complying with the customer
gross margin rule as applied to futures customer accounts. Pursuant to
this new system, each DCO's clearing members will submit data files to
the DCO identifying positions by numerical customer identifiers.\8\ OCC
will use this information to calculate margins, using STANS, for each
customer identifier of a clearing member and to aggregate those margin
calculations to determine the total futures customer margin requirement
for the clearing member's segregated futures customer account(s) held
at OCC.\9\ OCC will then compare the aggregate positions reported by
each clearing member with its own records and make any needed
adjustments to the margin calculation to ensure all positions on OCC's
books are properly margined.
---------------------------------------------------------------------------

    \8\ The position data provided to OCC by clearing members will
not include (a) information with respect to the allocation of margin
assets to particular customers, nor (b) information with respect to
settlement obligations arising from the exercise, assignment or
maturity of cleared contracts. For this reason, OCC will treat all
margin assets and settlement obligations for each account to which
the gross margin rule applies as being in sub-accounts of the
Clearing Member. OCC will calculate margin, using STANS, separately
for each sub-account and will aggregate the calculated margin
requirements at the level of the clearing member's segregated
futures customer account to which the sub-accounts relate.
    \9\ OCC currently carries the following account types that are
segregated pursuant to Section 4d of the Commodity Exchange Act:
Segregated Futures Accounts, Segregated Futures Professional
Accounts, non-Proprietary X-M accounts, and internal non-proprietary
cross-margining accounts. All such accounts would be margined on a
gross basis under the proposed amendments to Rule 601.
---------------------------------------------------------------------------

Proposed By-Law and Rule Changes
    The proposed changes to OCC's Rules provide for the calculation of
margin for segregated futures customer accounts on a gross basis and
mandate submission of the clearing member data files necessary to allow
OCC to calculate margin at the level of each futures customer. In the
event that the data included in these data files is incomplete (for
example, if OCC shows positions held in a clearing member's segregated
futures accounts, but those positions are not reflected in the data
file), OCC will create a separate sub-account to be used for margin
calculation purposes only. Positions recorded on OCC's books and
records, but not reflected in the data file, will be attributed to this
sub-account and a margin amount will be calculated for the sub-account.
This margin amount will be added to a clearing member's margin
requirement. OCC has determined to adopt this conservative approach to
dealing with discrepancies between its own records and clearing member
data files in order to ensure that OCC does not collect an inadequate
amount of margin from clearing members.
* * * * *
    The proposed changes to OCC's By-Laws are consistent with the
purposes and requirements of Section 17A of the Exchange Act because
they are designed to permit OCC to perform clearing services for
products that are subject to the jurisdiction of the CFTC without
adversely affecting OCC's obligations with respect to the prompt and
accurate clearance and settlement of securities transactions or the
protection of securities investors and the public interest. The
proposed rule change is not inconsistent with any rules of OCC.

(B) Clearing Agency's Statement on Burden on Competition

    OCC does not believe that the proposed changes contained in the
advance notice would impose any burden on competition not necessary or
appropriate in furtherance of the purposes of the Act.

(C) Clearing Agency's Statement on Comments on the Advance Notice
Received From Members, Participants, or Others

    Written comments were not and are not intended to be solicited with
respect to the proposed rule change and none have been received.

III. Date of Effectiveness of the Advance Notice and Timing for
Commission Action

    The proposed changes contained in the advance notice may be
implemented pursuant to Section 806(e)(1)(G) of Clearing Supervision
Act \10\ if the Commission does not object to the proposed changes
within 60 days of the later of (i) the date that the advance notice was
filed with the Commission or (ii) the date that any additional
information requested by the Commission is received. The clearing
agency shall not implement the proposed changes contained in the

advance notice if the Commission objects to the proposed changes.
---------------------------------------------------------------------------

    \10\ 12 U.S.C. 5465(e)(1)(G).
---------------------------------------------------------------------------

    The Commission may extend the period for review by an additional 60
days if the proposed changes raise novel or complex issues, subject to
the Commission providing the clearing agency with prompt written notice
of the extension. Proposed changes may be implemented in fewer than 60
days from the date the advance notice is filed, or the date further
information requested by the Commission is received, if the Commission
notifies the clearing agency in writing that it does not object to the
proposed changes and authorizes the clearing agency to implement the
proposed changes on an earlier date, subject to any conditions imposed
by the Commission.
    OCC has also filed the advance notice as a proposed rule change
pursuant to Section 19(b)(1) of the Act \11\ and Rule 19b-4
thereunder.\12\ Pursuant to those provisions, within 45 days of the
date of publication of this notice in the Federal Register or within
such longer period up to 90 days (i) as the Commission may designate if
it finds such longer period to be appropriate and publishes its reasons
for so finding or (ii) as to which the self-regulatory organization
consents, the Commission will: (A) By order approve or disapprove the
proposed rule change or (B) Institute proceedings to determine whether
the proposed rule change should be disapproved.
---------------------------------------------------------------------------

    \11\ 15 U.S.C. 78s(b)(1).
    \12\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

    The clearing agency shall post notice on its web site of proposed
changes that are implemented.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing. 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-OCC-2012-17 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-OCC-2012-17. This file
number should be included on the subject line if email 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 advance notice that are filed
with the Commission, and all written communications relating to the
advance notice 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 Web site viewing and printing 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 filings also will be available for inspection and
copying at the principal office of OCC and on OCC's Web site at http://www.optionsclearing.com/components/docs/legal/rules_and_bylaws/sr_occ_12_17.pdf.
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-OCC-2012-17
and should be submitted on or before October 22, 2012.

    By the Commission.
Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2012-24038 Filed 9-28-12; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: July 29, 2009 (Volume 74, Number 144)]
[Notices]
[Page 37767]
[DOCID:fr29jy09-139]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No FMCSA-1998-4334; FMCSA-2000-7006; FMCSA-2000-7363; FMCSA-
2000-8398; FMCSA-2001-9258; FMCSA-2003-14223; FMCSA-2003-14504; FMCSA-
2004-19477; FMCSA-2005-20027; FMCSA-2005-20560; FMCSA-2006-26066;
FMCSA-2007-27333; FMCSA-2007-27515.]

Qualification of Drivers; Exemption Renewals; Vision

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

ACTION: Notice of final disposition.

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SUMMARY: FMCSA previously announced its decision to renew the
exemptions from the vision requirement in the Federal Motor Carrier
Safety Regulations for 29 individuals. FMCSA has statutory authority to
exempt individuals from the vision requirement if the exemptions
granted will not compromise safety. The Agency has concluded that
granting these exemptions will provide a level of safety that will be
equivalent to, or greater than, the level of safety maintained without
the exemptions for these commercial motor vehicle (CMV) drivers.

FOR FURTHER INFORMATION CONTACT: Dr. Mary D. Gunnels, Director, Medical
Programs,<PHONE_NUMBER><EMAIL_ADDRESS>FMCSA, Department of
Transportation, 1200 New Jersey Avenue, SE., Room W64-224, Washington,
DC 20590-0001. Office hours are from 8:30 a.m. to 5 p.m. Monday through
Friday, except Federal holidays.

SUPPLEMENTARY INFORMATION:

Electronic Access

    You may see all the comments online through the Federal Document
Management System (FDMS) at http://www.regulations.gov.

Background

    Under 49 U.S.C. 31136(e) and 31315, FMCSA may grant an exemption
for a 2-year period if it finds ``such exemption would likely achieve a
level of safety that is equivalent to, or greater than, the level that
would be achieved absent such exemption.'' The statute also allows the
Agency to renew exemptions at the end of the 2-year period. The comment
period ended on July 2, 2009.

Discussion of Comments

    FMCSA received no comments in this proceeding.

Conclusion

    The Agency has not received any adverse evidence on any of these
drivers that indicates that safety is being compromised. Based upon its
evaluation of the 29 renewal applications, FMCSA renews the Federal
vision exemptions for Gary A. Barrett, Ivan L. Beal, Johnny A. Beutler,
Daniel R. Brewer, Darryl D. Cassatt, Larry Chinn, Brett L. Condon,
Albion C. Doe, Sr., William K. Gullet, Daryl A. Jester, James P. Jones,
Clyde H. Kitzan, Larry J. Lang, Spencer E. Leonard, Dennis D.
Lesperance, John W. Locke, Herman G. Lovell, Ronald L. Maynard, Donald
G. Meyer, William A. Moore, Jr., Earl R. Neugebauer, Danny R.
Pickelsimer, Richard S. Rehbein, Bernard E. Roche, David E. Sanders,
David B. Speller, Lynn D. Veach, Harry S. Warren, and Michael C. Wines.
    In accordance with 49 U.S.C. 31136(e) and 31315, each renewal
exemption will be valid for 2 years unless revoked earlier by FMCSA.
The exemption will be revoked if: (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 before it was
granted; or (3) continuation of the exemption would not be consistent
with the goals and objectives of 49 U.S.C. 31136 and 31315.

    Issued on: July 21, 2009.
Larry W. Minor,
Associate Administrator for Policy and Program Development.
[FR Doc. E9-17975 Filed 7-28-09; 8:45 am]

BILLING CODE 4910-EX-P