[Federal Register Volume 82, Number 86 (Friday, May 5, 2017)]
[Notices]
[Pages 21214-21215]
[FR Doc No: 2017-09110]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP16-498-000]

Columbia Gas Transmission, LLC; Notice of Availability of the
Environmental Assessment for the Proposed B-System Project

    The staff of the Federal Energy Regulatory Commission (FERC or
Commission) has prepared an environmental assessment (EA) for the B-
System Project, proposed by Columbia Gas Transmission, LLC (Columbia)
in the above-referenced docket. Columbia requests authorization to
modernize and upgrade Columbia's B-System pipelines by replacing and
abandoning existing pipeline as well as constructing new pipeline and
appurtenant facilities in Fairfield and Franklin Counties, Ohio.
    The EA assesses the potential environmental effects of the
construction and operation of the B-System Project in accordance with
the requirements of the National Environmental Policy Act (NEPA). The
FERC staff concludes that approval of the proposed project, with
appropriate mitigating measures, would not constitute a major federal
action significantly affecting the quality of the human environment.
    The U.S. Army Corps of Engineers and Ohio Department of Natural
Resources participated as cooperating agencies in the preparation of
the EA. Cooperating agencies have jurisdiction by law or special
expertise with respect to resources potentially affected by the
proposal and participate in the NEPA analysis.
    As part of its proposed B-System Project, Columbia would:
     Abandon in place approximately 17.5 miles of 20-inch-
diameter pipeline, remove two associated mainline valves (mileposts 7.7
and 10.9), install two gas heaters, and remove various exposed pipe
segments on Columbia's Line B-105;
     construct approximately 14.0 miles of 20-inch-diameter
replacement pipeline on Columbia's Line B-111;
     construct approximately 0.1 mile of 4-inch-diameter
replacement pipeline on Columbia's Line B-121;
     construct approximately 0.5 mile of 4-inch-diameter
replacement pipeline on Columbia's Line B-130;
     construct approximately 7.6 miles of new 20-inch-diameter
pipeline (``Line K-270'') connecting Columbia's K-System and B-System;
and
     remove, replace, restore, and install various
appurtenances including connections, valves, aboveground piping, one
regulation facility, and pig \1\ launchers and receivers.
---------------------------------------------------------------------------

    \1\ A ``pig'' is a tool that the pipeline company inserts into
and pushes through the pipeline for cleaning the pipeline,
conducting internal inspections, or other purposes.
---------------------------------------------------------------------------

    The FERC staff mailed copies of the EA to federal, state, and local
government representatives and agencies; elected officials;
environmental and public interest groups; Native American tribes;
potentially affected landowners and other interested individuals and
groups; and newspapers and libraries in the project area. In addition,
the EA is available for public viewing on the FERC's Web site
(www.ferc.gov) using the eLibrary link. A limited number of copies of
the EA are available for distribution and public inspection at: Federal
Energy Regulatory Commission, Public Reference Room, 888 First Street
NE., Room 2A, Washington, DC 20426,<PHONE_NUMBER>.
    Any person wishing to comment on the EA may do so. Your comments
should focus on the potential environmental effects, reasonable
alternatives, and measures to avoid or lessen environmental impacts.
The more specific your comments, the more useful they will be. To
ensure that the Commission has the opportunity to consider your
comments prior to making its decision on this project, it is important
that we receive your comments in Washington, DC on or before May 30,
2017.
    For your convenience, there are three methods you can use to file
your comments with the Commission. In all instances please reference
the project docket number (CP16-498-000) with your submission. The
Commission

encourages electronic filing of comments and has expert staff available
to assist you at<PHONE_NUMBER> or<EMAIL_ADDRESS>    (1) You can file your comments electronically using the eComment
feature located on the Commission's Web site (www.ferc.gov) under the
link to Documents and Filings. This is an easy method for submitting
brief, text-only comments on a project;
    (2) You can also file your comments electronically using the
eFiling feature on the Commission's Web site (www.ferc.gov) under the
link to Documents and Filings. With eFiling, you can provide comments
in a variety of formats by attaching them as a file with your
submission. New eFiling users must first create an account by clicking
on ``eRegister.'' You must select the type of filing you are making. If
you are filing a comment on a particular project, please select
``Comment on a Filing''; or
    (3) You can file a paper copy of your comments by mailing them to
the following address: Kimberly D. Bose, Secretary, Federal Energy
Regulatory Commission, 888 First Street NE., Room 1A, Washington, DC
20426.
    Any person seeking to become a party to the proceeding must file a
motion to intervene pursuant to Rule 214 of the Commission's Rules of
Practice and Procedures (18 CFR 385.214).\2\ Only intervenors have the
right to seek rehearing of the Commission's decision. The Commission
grants affected landowners and others with environmental concerns
intervenor status upon showing good cause by stating that they have a
clear and direct interest in this proceeding which no other party can
adequately represent. Simply filing environmental comments will not
give you intervenor status, but you do not need intervenor status to
have your comments considered.
---------------------------------------------------------------------------

    \2\ See the previous discussion on the methods for filing
comments.
---------------------------------------------------------------------------

    Additional information about the project is available from the
Commission's Office of External Affairs, at (866) 208-FERC, or on the
FERC Web site (www.ferc.gov) using the eLibrary link. Click on the
eLibrary link, click on ``General Search,'' and enter the docket number
excluding the last three digits in the Docket Number field (i.e., CP16-
498). Be sure you have selected an appropriate date range. For
assistance, please contact FERC Online Support at
<EMAIL_ADDRESS>or toll free at<PHONE_NUMBER>, or for TTY,
contact<PHONE_NUMBER>. The eLibrary link also provides access to the
texts of formal documents issued by the Commission, such as orders,
notices, and rulemakings.
    In addition, the Commission offers a free service called
eSubscription which allows you to keep track of all formal issuances
and submittals in specific dockets. This can reduce the amount of time
you spend researching proceedings by automatically providing you with
notification of these filings, document summaries, and direct links to
the documents. Go to www.ferc.gov/docs-filing/esubscription.asp.

    Dated: April 28, 2017.
Kimberly D. Bose,
 Secretary.
[FR Doc. 2017-09110 Filed 5-4-17; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 86, Number 195 (Wednesday, October 13, 2021)]
[Notices]
[Pages 56979-56980]
[FR Doc No: 2021-22187]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID: FEMA-2021-0025; OMB No. 1660-0138]

Agency Information Collection Activities: Proposed Collection;
Comment Request; Direct Housing Assistance Forms

AGENCY: Federal Emergency Management Agency, Department of Homeland
Security.

ACTION: 60-day notice of revision and request for comments.

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SUMMARY: The Federal Emergency Management Agency (FEMA), as part of its
continuing effort to reduce paperwork and respondent burden, invites
the general public to take this opportunity to comment on a revision of
a currently approved information collection. In accordance with the
Paperwork Reduction Act of 1995, this notice seeks comments concerning
information collected by FEMA to provide temporary housing units,
including manufactured housing units, recreational vehicles and other
readily fabricated dwellings to eligible applicants who, as a direct
result of a major disaster or emergency, are unable to occupy their
primary residence or obtain adequate alternate housing, and therefore
require temporary housing.

DATES: Comments must be submitted on or before December 13, 2021.

ADDRESSES: To avoid duplicate submissions to the docket, please submit
comments at www.regulations.gov under Docket ID FEMA-2021-0025. Follow
the instructions for submitting comments.
    All submissions received must include the agency name and Docket
ID. Regardless of the method used for submitting comments or material,
all submissions will be posted, without change, to the Federal
eRulemaking Portal at http://www.regulations.gov, and will include any
personal information you provide. Therefore, submitting this
information makes it public. You may wish to read the Privacy Act
notice that is available via the link in the footer of http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Brian Thompson, Supervisory Program
Specialist, FEMA, Recovery Directorate, at<PHONE_NUMBER> or
[email protected]. You may contact the Information
Management Division for copies of the proposed collection of
information at email address: [email protected].

SUPPLEMENTARY INFORMATION: The Robert T. Stafford Disaster Relief and
Emergency Assistance Act, 42 U.S.C. 5174, as amended by the Disaster
Mitigation Act of 2000 (Pub. L. 106-390), authorizes the President to
provide temporary housing units, including manufactured housing units,
recreational vehicles and other readily fabricated dwellings to
eligible applicants who, as a direct result of a major disaster or
emergency, are unable to occupy their primary residence or obtain
adequate alternate housing, and therefore require temporary housing.
Requirements for disaster-related housing needs of individuals and
households who are eligible for temporary housing assistance may be
found in Title 44 CFR 206.117--Housing Assistance. The information

collected is used to determine the feasibility of a potential site for
placement of temporary housing units (THUs) to ensure the THUs are
ready for applicant occupancy, and to confirm applicant understanding
of the requirements of occupancy of the THUs. The information will also
provide FEMA with access to place the THUs, to document the
installation and maintenance of the THUs, and to retrieve the THUs at
the end of their use.

Collection of Information

    Title: Direct Housing Assistance Forms.
    Type of Information Collection: Revision of a currently approved
information collection.
    OMB Number: 1660-0138.
    FEMA Forms: FEMA Form FF-104-FY-21-191 (English) (formerly 009-0-
129), Transportable Temporary Housing Unit Ready for Occupancy Status;
FF-104-FY-21-192 (English) (formerly 009-0-131), Sales Calculation
Worksheet; FF-104-FY-21-193 (English) (formerly 009-0-134), Direct
Temporary Housing Assistance Recertification Worksheet; FF-104-FY-21-
194 (English) (formerly 009-0-135), Direct Temporary Housing Assistance
Temporary Housing Agreement; FF-104-FY-21-195 (English) (formerly 009-
0-137), Commercial Park Unit Pad Requirements--Information Checklist;
FEMA Form FF-104-FY-21-109 (English) (formerly 010-0-9), Transportable
Temporary Housing Unit Request for the Site Inspection; FEMA Form FF-
104-FY-21-110 (formerly 010-0-10) Transportable Temporary Housing Unit
Landowner's Authorization Ingress-Egress Agreement; FEMA Form FF-104-
FY-21-110-A (English/Spanish) (formerly 010-0-10S), Autorizaci[oacute]n
del Propietario/Acuerdo de Entrada y Salida; FF-104-FY-21-111 (English)
(formerly 009-0-138), Transportable Temporary Housing Unit Inspection
Report; FF-104-FY-21-112 (English) (formerly 009-0-136), Transportable
Temporary Housing Unit Installation Work Order; FF-104-FY-21-113
(English) (formerly 009-0-130), Transportable Temporary Housing Unit
Maintenance Work Order.
    Abstract: The information collected is used to determine the
feasibility of a potential site for placement of temporary housing
units (THUs) to ensure the THUs are ready for applicant occupancy, and
to confirm applicant understanding of the requirements of occupancy of
the THUs. The information will also provide FEMA with access to place
the THUs, to document the installation and maintenance of the THUs, and
to retrieve the THUs at the end of their use.
    Affected Public: Individuals or households, business or other for-
profit.
    Estimated Number of Respondents: 50,000.
    Estimated Number of Responses: 50,000.
    Estimated Total Annual Burden Hours: 12,088.
    Estimated Total Annual Respondent Cost: $563,318.
    Estimated Respondents' Operation and Maintenance Costs: $0.
    Estimated Respondents' Capital and Start-Up Costs: $0.
    Estimated Total Annual Cost to the Federal Government: $10,631,850.

Comments

    Comments may be submitted as indicated in the ADDRESSES caption
above. Comments are solicited to (a) evaluate whether the proposed data
collection is necessary for the proper performance of the agency,
including whether the information shall have practical utility; (b)
evaluate the accuracy of the agency's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (c) enhance the quality, utility, and
clarity of the information to be collected; and (d) minimize the burden
of the collection of information on those who are to respond, including
through the use of appropriate automated, electronic, mechanical, or
other technological collection techniques or other forms of information
technology, e.g., permitting electronic submission of responses.

Millicent L. Brown,
Acting Branch Chief, Records Management Branch, Office of the Chief
Administrative Officer, Mission Support, Federal Emergency Management
Agency, Department of Homeland Security.
[FR Doc. 2021-22187 Filed 10-12-21; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register Volume 79, Number 204 (Wednesday, October 22, 2014)]
[Notices]
[Page 63154]
[FR Doc No: 2014-25073]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4192-DR; Docket ID FEMA-2014-0003]

American Samoa; Major Disaster and Related Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This is a notice of the Presidential declaration of a major
disaster for the Territory of American Samoa (FEMA-4192-DR), dated
September 10, 2014, and related determinations.

DATES: Effective Date: September 10, 2014.

FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW.,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Notice is hereby given that, in a letter
dated September 10, 2014, the President issued a major disaster
declaration under the authority of the Robert T. Stafford Disaster
Relief and Emergency Assistance Act, 42 U.S.C. 5121 et seq. (the
``Stafford Act''), as follows:

    I have determined that the damage in certain areas of the
Territory of American Samoa resulting from severe storms, flooding,
and landslides during the period of July 29 to August 3, 2014, is of
sufficient severity and magnitude to warrant a major disaster
declaration under the Robert T. Stafford Disaster Relief and
Emergency Assistance Act, 42 U.S.C. 5121 et seq. (the ``Stafford
Act''). Therefore, I declare that such a major disaster exists in
the Territory of American Samoa.
    In order to provide Federal assistance, you are hereby
authorized to allocate from funds available for these purposes such
amounts as you find necessary for Federal disaster assistance and
administrative expenses.
    You are authorized to provide Public Assistance in the
designated areas and Hazard Mitigation throughout the Territory of
American Samoa. Consistent with the requirement that Federal
assistance be supplemental, any Federal funds provided under the
Stafford Act for Hazard Mitigation will be limited to 75 percent of
the total eligible costs. Federal funds provided under the Stafford
Act for Public Assistance also will be limited to 75 percent of the
total eligible costs, with the exception of projects that meet the
eligibility criteria for a higher Federal cost-sharing percentage
under the Public Assistance Alternative Procedures Pilot Program for
Debris Removal implemented pursuant to section 428 of the Stafford
Act.
    Further, you are authorized to make changes to this declaration
for the approved assistance to the extent allowable under the
Stafford Act.

    The Federal Emergency Management Agency (FEMA) hereby gives notice
that pursuant to the authority vested in the Administrator, under
Executive Order 12148, as amended, Kenneth K. Suiso, of FEMA is
appointed to act as the Federal Coordinating Officer for this major
disaster.
    The following areas have been designated as adversely affected by
this major disaster:

    The Territory of American Samoa for Public Assistance.
    All areas within the Territory of American Samoa are eligible
for assistance under the Hazard Mitigation Grant Program.
    The following Catalog of Federal Domestic Assistance Numbers
(CFDA) are to be used for reporting and drawing funds: 97.030,
Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis
Counseling; 97.033, Disaster Legal Services; 97.034, Disaster
Unemployment Assistance (DUA); 97.046, Fire Management Assistance
Grant; 97.048, Disaster Housing Assistance to Individuals and
Households In Presidentially Declared Disaster Areas; 97.049,
Presidentially Declared Disaster Assistance--Disaster Housing
Operations for Individuals and Households; 97.050, Presidentially
Declared Disaster Assistance to Individuals and Households--Other
Needs; 97.036, Disaster Grants--Public Assistance (Presidentially
Declared Disasters); 97.039, Hazard Mitigation Grant.

W. Craig Fugate,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2014-25073 Filed 10-21-14; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register: May 12, 2008 (Volume 73, Number 92)]
[Notices]
[Page 26975-26976]
[DOCID:fr12my08-25]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 13125-000]

MARMC Enterprises, LLC; Notice of Application Accepted for Filing
and Soliciting Comments, Motions To Intervene, and Protests

May 5, 2008.
    Take notice that the following hydroelectric applications have been
filed with the Commission and are available for public inspection:
    a. Type of Application: Preliminary Permit.
    b. Project No.: P-13125-000.
    c. Date Filed: March 3, 2008.
    d. Applicant: MARMC Enterprises, LLC.
    e. Name of the Project: Belair Project.
    f. Location: The project would be located on the Mississippi River
in Plaquemines Parish, Louisiana. The project uses no dam or
impoundment.
    g. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791a-825r.
    h. Applicants Contact: Ms. Nicoline Marinovich, 722 Oak Lane,
Thibodaux, LA 70301,<PHONE_NUMBER>.
    i. FERC Contact: Patricia W. Gillis,<PHONE_NUMBER>.
    j. Deadline for filing comments, protests, and motions to
intervene: 60 days from the issuance date of this notice.
    All documents (original and eight copies) should be filed with:
Secretary, Federal Energy Regulatory Commission, 888 First Street, NE.,
Washington, DC 20426. Comments, protests, and interventions may be
filed electronically via the Internet in lieu of paper; see 18 CFR
385.2001(a)(1)(iii) and the instructions on the Commission's Web site
under the ``e-Filing'' link. The Commission strongly encourages
electronic filings. Please include the project number (P-13125-000) on
any comments or motions filed.
    The Commission's Rules of Practice and Procedure require all
intervenors filing documents with the Commission to serve a copy of
that document on each person in the official service list for the
project. Further, if an intervenor files comments or documents with the
Commission relating to the merits of an

issue that may affect the responsibilities of a particular resource
agency, they must also serve a copy of the document on that resource
agency.
    k. Description of Project: The proposed project would consist of:
(1) Up to 40 proposed 336.8-kilowatt Underwater Electric Kite
generating units having a total installed capacity of 16-megawatts, (2)
a proposed transmission line, and (4) appurtenant facilities. The
project would have an average annual generation of 137.3-gigawatt-hours
and be sold to a local utility.
    l. Location of Application: A copy of the application is available
for inspection and reproduction at the Commission in the Public
Reference Room, located at 888 First Street, NE., Room 2A, Washington,
DC 20426, or by calling<PHONE_NUMBER>. This filing may also be viewed
on the Commission's Web site at 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, call toll-free 1-866-208-3676 or e-mail
<EMAIL_ADDRESS>For TTY, call<PHONE_NUMBER>. A copy is
also available for inspection and reproduction at the address in item h
above.
    m. Individuals desiring to be included on the Commission's mailing
list should so indicate by writing to the Secretary of the Commission.
    n. Competing Preliminary Permit--Anyone desiring to file a
competing application for preliminary permit for a proposed project
must submit the competing application itself, or a notice of intent to
file such an application, to the Commission on or before the specified
comment date for the particular application (see 18 CFR 4.36).
Submission of a timely notice of intent allows an interested person to
file the competing preliminary permit application no later than 30 days
after the specified comment date for the particular application. A
competing preliminary permit application must conform with 18 CFR 4.30
and 4.36.
    o. Competing Development Application--Any qualified development
applicant desiring to file a competing development application must
submit to the Commission, on or before a specified comment date for the
particular application, either a competing development application or a
notice of intent to file such an application. Submission of a timely
notice of intent to file a development application allows an interested
person to file the competing application no later than 120 days after
the specified comment date for the particular application. A competing
license application must conform with 18 CFR 4.30 and 4.36.
    p. Notice of Intent--A notice of intent must specify the exact
name, business address, and telephone number of the prospective
applicant, and must include an unequivocal statement of intent to
submit, if such an application may be filed, either a preliminary
permit application or a development application (specify which type of
application). A notice of intent must be served on the applicant(s)
named in this public notice.
    q. Proposed Scope of Studies Under Permit--A preliminary permit, if
issued, does not authorize construction. The term of the proposed
preliminary permit would be 36 months. The work proposed under the
preliminary permit would include economic analysis, preparation of
preliminary engineering plans, and a study of environmental impacts.
Based on the results of these studies, the Applicant would decide
whether to proceed with the preparation of a development application to
construct and operate the project.
    r. Comments, Protests, or Motions to Intervene--Anyone may submit
comments, a protest, or a motion to intervene in accordance with the
requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211,
.214. In determining the appropriate action to take, the Commission
will consider all protests or other comments filed, but only those who
file a motion to intervene in accordance with the Commission's Rules
may become a party to the proceeding. Any comments, protests, or
motions to intervene must be received on or before the specified
comment date for the particular application.
    Comments, protests and interventions may be filed electronically
via the Internet in lieu of paper. See 18 CFR 385.2001(a)(1)(iii) and
the instructions on the Commission's Web site at http://www.ferc.gov
under the ``e-Filing'' link.
    s. Filing and Service of Responsive Documents--Any filings must
bear in all capital letters the title ``COMMENTS'', ``NOTICE OF INTENT
TO FILE COMPETING APPLICATION'', ``COMPETING APPLICATION'',
``PROTEST'', and ``MOTION TO INTERVENE'', as applicable, and the
Project Number of the particular application to which the filing
refers. Any of the above-named documents must be filed by providing the
original and the number of copies provided by the Commission's
regulations to: The Secretary, Federal Energy Regulatory Commission,
888 First Street, NE., Washington, DC 20426. An additional copy must be
sent to Director, Division of Hydropower Administration and Compliance,
Federal Energy Regulatory Commission, at the above-mentioned address. A
copy of any notice of intent, competing application or motion to
intervene must also be served upon each representative of the Applicant
specified in the particular application.
    t. Agency Comments--Federal, state, and local agencies are invited
to file comments on the described application. A copy of the
application may be obtained by agencies directly from the Applicant. If
an agency does not file comments within the time specified for filing
comments, it will be presumed to have no comments. One copy of an
agency's comments must also be sent to the Applicant's representatives.

Kimberly D. Bose,
Secretary.
 [FR Doc. E8-10458 Filed 5-9-08; 8:45 am]

BILLING CODE 6717-01-P


                  UNITED STATES ENVIRONMENTAL PROTECTION AGENCY                 NATIONAL VEHICLE AND FUEL EMISSIONS LABORATORY                              2000 TRAVERWOOD DRIVE                            ANN ARBOR, MI  48105-2498

									     OFFICE OF 									AIR AND RADIATION 3/31/16

MEMORANDUM

SUBJECT: Honeywell visit on Phase 2 Technology Update

FROM: Houshun Zhang

TO:  Greenhouse Gas Emissions Standards and Fuel Efficiency Standards for Medium- and Heavy-Duty Engines and Vehicles - Phase 2 - Docket EPA-HQ-OAR-2014-0827

This memo documents an on-site meeting at EPA on March 31, 2016 between Honeywell and EPA on their technology update to the Phase 2 greenhouse gas and fuel efficiency standards for heavy-duty vehicles.  Five people from Honeywell attended the meeting:  Stacey Bernards (VP), Mark Rodrigues (Director), PJ Cancalon (Manager), Rob Cadle (Manager).

During the meeting, they provided the updates on their advanced technology development, including different turbocharger technologies.  The meeting also talked about their public comments to our NPRM.


UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

	OFFICE OF CHEMICAL SAFETY

	AND POLLUTION PREVENTION

MEMORANDUM

Date:		04/16/2013

SUBJECT:	Pyraclostrobin:   Request for the Use on Sugarcane.  Summary of
Analytical Chemistry and Residue Data.

PC Code:  099100	DP Barcodes: 403449; ,403451; 403452; 403453; 403454;
403456; 403462;

Decision No.: 465126	Registration Nos.: 7969-185; 7969-186; 7969-247;
7969-258; 7969- 289; 7969-291

Petition Nos.: 2F8038	Regulatory Action:  Section 3 Registration

Risk Assessment Type: Single Chemical/Aggregate	Case No.: N/A

TXR No.: N/A	CAS No.: 175013-18-0

MRID No.: 48237401	40 CFR: 180.582

FROM:	Stephen Funk, Senior Chemist

		Risk Assessment Branch III (RAB III)

		Health Effects Division (HED; 7509P)

THROUGH:	Christine Olinger, Branch Chief

		Risk Assessment Branch III (RAB III)

		Health Effects Division (HED; 7509P)

TO:		T. Kish/d. Schuler, RM# 22

		Fungicide Branch

		Registration Division (RD; 7505P)

		And

		Barry O’Keefe, Senior Biologist

		Risk Assessment Branch III (RAB III)

		Health Effects Division (HED; 7509P)

Executive Summary

  SEQ CHAPTER \h \r 1 Pyraclostrobin, or methyl
N-[2-[[[1-(4-chlorophenyl)-1H-pyrazol-3-yl]oxy]methyl]phenyl]-N-methoxyc
arbamate, belongs to the strobilurin class of fungicides.  Strobilurins
are synthetic analogs of a natural antifungal substance which inhibits
spore germination, mycelial growth, and sporulation of the fungi causing
diseases such as fruit rot in strawberry, early leaf rot in peanuts,
late blight in pistachios, rust diseases in soybeans, and pre- and
post-fruit rot of pome and stone fruits.  The fungicide is currently
registered to BASF Corporation (BASF) for use on a variety of field,
vegetable, fruit, and nut crops.  It is formulated as water-dispersible
granules (WDG) or an emulsifiable concentrate (EC) and is typically
applied as foliar applications using ground or aerial equipment at
maximum seasonal rates of 0.3-3.0 lb ai/A.  The 20% WDG formulation is
also registered for use as a seed treatment on some crops.

BASF is proposing a new use for pyraclostrobin on sugarcane.  The
proposed use is for up to four applications of an EC or SC formulation
at 0.20 lb ai/acre with a seasonal maximum rate of 0.80 lb ai/acre and a
14 day preharvest interval (PHI). There is an existing Section 18
tolerance for sugarcane.

BASF has proposed the establishment of a tolerance for the 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) pyrazol-3-yl]oxy]o-tolyl] carbamate,
expressed as parent compound, in or on the following raw agricultural
commodity:

	Sugarcane, cane………………………………….0.2 ppm

  SEQ CHAPTER \h \r 1 Tolerances have been established in 40 CFR
§180.582 for residues of the fungicide pyraclostrobin, including its
metabolites and degradates.  Compliance with the tolerance levels is to
be determined by measuring only the sum 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]phenyl carbamate),
calculated as the stoichiometric  equivalent of pyraclostrobin .  The
established tolerances for plant food commodities range from 0.02 ppm
in/on wheat grain to 29 ppm in/on leafy vegetables, except Brassica.
Tolerances for livestock commodities are listed in 40 CFR §180.582
(a)(2) and are expressed in terms of the combined residues of the
fungicide pyraclostrobin and its metabolites convertible to
1-(4-chlorophenyl)-1H-pyrazol-3-ol and
1-(4-chloro-2-hydroxyphenyl)-1H-pyrazol-3-ol, expressed as parent
compound.  The established tolerances for livestock commodities range
from 0.1 to 1.5 ppm; no tolerances are established for poultry
commodities.

HED (D278044, Metabolism Assessment Review Committee (MARC), 10/09/01)
has determined that for purposes of tolerance and dietary risk
assessments, the residues of concern in plant and rotational crop
commodities include pyraclostrobin and desmethoxy metabolite (BF 500-3).
 The residues of concern in livestock commodities include pyraclostrobin
and its metabolites convertible to 1-(4-chlorophenyl)-1H-pyrazol-3-ol
(BF 500-5) and 1-(4-chloro-2-hydroxyphenyl)-1H-pyrazol-3-ol (BF 500-8).

There are adequate residue analytical methods for tolerance enforcement.
   SEQ CHAPTER \h \r 1 The analytical methods for plant commodities are
liquid chromatography with tandem mass spectrometry (LC/MS/MS) and high
pressure liquid chromatography with ultraviolet detection (HPLC/UV),
which both measure pyraclostrobin and its desmethoxy metabolite.  The
analytical methods for livestock commodities, gas chromatography with
mass spectrometry (GC/MS) and LC/MS/MS, convert pyraclostrobin and
related metabolites to chlorophenylpyrazolol (BF 500-5) and hydroxylated
chlorophenylpyrazolol (BF 500-8) in goats and chlorophenylpyrazolol (BF
500-5) and a hydroxylated chlorophenylpyrazolol isomer of BF 500-8 (BF
500-9) in poultry.

Samples were analyzed for pyraclostrobin using BASF Analytical Method
Number D9908 (Version 2), "Method for Determining BAS 500 F, BF 500-3
and BAS 510 F Residues in Plant Matrices using LC/MS/MS."  The final
chromatographic analysis of residues was determined by LC/MS/MS.  The
lower limit of method validation (LLMV) in this study was 0.02 ppm for
both pyraclostrobin and BF 500-3.  The LC/MS/MS method used to determine
residues of pyraclostrobin and BF 500-3 were adequately validated in
conjunction with the field sample analyses.  The average recovery of all
pyraclostrobin and BF 500-3 fortifications was adequate.  The method is
adequate for data collection.

The requirements for multiresidue methods testing data are fulfilled.
Pyraclostrobin was successfully evaluated through several of the FDA
protocols (complete recovery through protocols D and E), while recovery
of metabolite BF 500-3 was unsuccessful in all protocols.

Samples of sugarcane from field trials were stored frozen for up to 24.9
months prior to analysis. Samples of sugarcane RAC, blackstrap molasses,
and refined sugar from the processing study were stored frozen for up to
17.0 months from collection to extraction  Submitted freezer storage
stability data indicate that residues of pyraclostrobin and BF 500-3 are
stable in diverse representative crop matrices for up to 25 months.
These data are adequate to support the storage conditions and durations
of samples from the sugarcane field trials and processing studies.

Sugarcane molasses is a livestock feed item of regulatory interest,
comprising up to 10% of the diet of dairy and beef cattle.  Low
concentration of pyraclostrobin in the processed commodity from the
proposed use will have no effect on the calculated livestock diet.

BASF has submitted field trial data for eight trials for pyraclostrobin
sugarcane in the USA. At each trial location, the treated plots received
four foliar directed or foliar broadcast applications of a 2.09 lb
ai/gal emulsifiable concentrate (EC) formulation of pyraclostrobin
(Headline®) during the vegetative or bloom stages of development at
rates of 0.189-0.206 lb ai/A/application (0.21-0.23 kg
ai/ha/application), for total seasonal rates of 0.78-0.81 lb ai/A
(0.88-0.91 kg ai/ha).  Retreatment intervals (RTIs) were 13-14 days.
Applications were made using ground equipment in spray volumes of
15.54-27.15 gal/A of water (145-254 L/ha).  A nonionic surfactant (NIS)
was added to the spray mixture at each trial in the LA and TX trials;
however, no adjuvant was used in the FL trials. Samples of sugarcane
were harvested from trials at preharvest intervals (PHIs) of 13-14 and
27-28 days.

Residues (and per trial averages) of pyraclostrobin, of BF 500-3, and of
combined pyraclostrobin and BF 500-3 in/on sugarcane harvested at a 13-
to 14-day PHI were <0.02-0.1049 (<0.02-0.099), <0.02-0.0267
(<0.02-0.027), and <0.04-<0.1249 (<0.040-<0.119) ppm, respectively.
Following the same treatment at a 27- to 28-day PHI, residues of BF
500-3 in/on all sugarcane samples were <0.02 ppm, and residues (and per
trial averages) of pyraclostrobin and of combined pyraclostrobin and BF
500-3 were <0.02-0.0866 (<0.020-0.068) and <0.04-<0.1066 (<0.040-<0.088)
ppm, respectively.

A processing study was also conducted for sugarcane.  At two trial
locations (Trial IDs 08-FL32 and 08-TX24), an additional plot received
four foliar directed or foliar broadcast applications of the Headline®
formulation of pyraclostrobin during the vegetative or bloom stages of
development at rates of 0.977-1.04 lb ai/A/application (1.09-1.13 kg
ai/ha/application), for total seasonal rates of 3.94-3.99 lb ai/A
(4.42-4.47 kg ai/ha, 5x rate).  Sugarcane was processed within 21-27
days of harvest into blackstrap molasses and refined sugar using
simulated commercial procedures.  Concentration of pyraclostrobin and BF
500-3 did not occur.

Analytical reference standards for pyraclostrobin and its regulated
metabolites are available at the EPA National Pesticide Standards
Repository.

Adequate confined, limited and extensive field rotational crop studies
are available supporting the existing tolerances for indirect residues
of pyraclostrobin in rotational crops.  These data support the 14-day
plant-back interval currently specified for crops without pyraclostrobin
uses.  No additional rotational crop data are required for purposes of
this petition.

Regulatory Recommendations and Residue Chemistry Deficiencies

HED has examined the residue chemistry database for pyraclostrobin and
concludes that pending submission of a revised label there are no
residue chemistry deficiencies that would preclude granting Section 3
registration for the requested crop commodity use of pyraclostrobin, or
establishment of a tolerance for residues of pyraclostrobin.  It is
recommended that a tolerance be established for residues of the
fungicide pyraclostrobin, including its metabolites and degradates, in
or on sugarcane, cane at 0.2 ppm. Compliance with the tolerance levels
is to be determined by measuring only the sum 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]phenyl carbamate),
calculated as the stoichiometric equivalent of pyraclostrobin .

A human health risk assessment is forthcoming.

860.1200  Direction for Use

A revised label is required for EPA Reg.No. 7969-247 (12.0% EC,
Multiva®).  The proposed label has a maximum seasonal rate of 0.52 lb
ai/acre.  However, the directions state that no more than 80 ozs of
Multiva™ should be applied per season, which is equivalent to 0.68 lb
ai.  The 80 ozs is incorrect and must be changed to 62 ounces of
product.

	Background

Pyraclostrobin belongs to the strobilurin class of fungicides.
Strobilurins are synthetic analogs of a natural antifungal substance
which inhibits spore germination and mycelial growth and sporulation of
the fungus on the leaf surface.  The chemical structure and nomenclature
of pyraclostrobin are presented in Table 1.  The physicochemical
properties of the technical grade of pyraclostrobin are presented in
Table 2.

TABLE 1.	Test Compound Nomenclature.

Compound

Common name	Pyraclostrobin

Company experimental name	BAS 500 F

IUPAC name	methyl
2-[1-(4-chlorophenyl)pyrazol-3-yloxymethyl]-N-methoxycarbanilate

CAS name	methyl
N-[2-[[[1-(4-chlorophenyl)-1H-pyrazol-3-yl]oxy]methyl]phenyl]-N-methoxyc
arbamate

CAS registry number	175013-18-0

End-use product (EP)	Headline® EC Fungicide, EPA Reg. No. 7969-186.

TABLE 2.	Physicochemical Properties of Technical Grade Pyraclostrobin.

Parameter	Value	References1  (MRID)

Melting point/range	63.7-65.2ºC	45118213

pH	Not applicable

	Density	1.367 g/cm3 	45118214

Water solubility at 20 ºC	1.9 ±  0.17 mg/L (deionized water, pH 5.8)

	45118233

Solvent solubility	n-heptane (0.37 g/100mL);  2-propanol (3.0 g/100mL);
1-octanol (2.42 g/100mL);  olive oil (2.80 g/100m/L);  methanol  (10.08
g/100mL); >50 g/100mL in acetone, ethyl acetate , acetonitrile,
dichloromethane and toluene.	45118228

Vapor pressure	2.6 x 10-10 hPa at 20 ºC

	45118214

Dissociation constant, pKa	None (no dissociable moieties)

	Octanol/water partition coefficient, Log(KOW) at room temperature	3.990
mean log Pow; Pow is 9772

	45118215

UV/visible absorption spectrum	The structural identity of BAS 500 F was
confirmed by NMR and MS spectra. UV molecular extinction (e [1 mol-1
cm-1]): 2.5x104 at 205 nm; 2.4x104 at 275 nm.	1996/109552

1	Product Chemistry data were reviewed by the Registration Division (DP#
269848 and DP# 274191, 5/3/01, 5/15/01, and 6/7/01, S. Malak).

2	BASF  Document Number.

860.1200  Directions for Use

Proposed supplemental labels were provided for end use products7969-186,
7969-247, 7969-289, and 7969-291.  Supplemental labels were also
supplied for the technical products 7969-185 (98.0%) and 7969-258
(90.2%).

TABLE 3.  Summaryof Proposed Use Patterns of Pyraclostrobin.

Applic. Timing, Type, and Equip.	Formulation

[EPA Reg. No.]	Applic. Rate

(lb ai/A)	Max. No. Applic. per Season	Max. Seasonal Applic. Rate

(lb ai/A)	PHI

(days)	Use Directions and Limitations

Sugarcane

Foliar with ground equipment, aerial equipment, or sprinkler irrigation1
23/6%

2.09 lb ai/gal

™ EC

7969-186	0.146-0.196	N/S	0.78	14	Apply at 14 – 28 day intervals with
no more than 2 sequential applications before alternating to a labeled
non Group 11 fungicide.

Foliar with ground equipment, aerial equipment,  or sprinkler
irrigation1	12.0%

+ 7.4% metconazole

1.083 lb ai/gal

[0.67 lb metconazole

/gal]

Multiva™EC

7969-247	0.10-0.13	4	0.52	14	Apply at 14 – 28 day intervals with no
more than 2 sequential applications before alternating to a labeled non
Group 11 or non Group 3 fungicide.

Do not apply more than 80 oz of Multiva per acre per season [0.68 lb
ai/acre]..

Foliar with ground equipment, aerial equipment, ,or sprinkler
irrigation1	23.3%

2.08 lb ai/gal

Headline™ SC

7969-289	0.195	N/S	0.78	14	Apply at 14 – 28 day intervals with no more
than 2 sequential applications before alternating to a labeled non Group
11 fungicide.

Foliar with ground equipment, aerial equipment,  or sprinkler
irrigation1	13.64%

+5.14% metconazole

1.22 lb ai/gal

[0.46 lb metconazole /gal]

BAS 556 SC

7969-291	0.14-0.19	4	0.76	14	Apply at 14 – 28 day intervals with no
more than 2 sequential applications before alternating to a labeled non
Group 11 or non Group 3 fungicide.

Do not apply more than 80 oz of Multiva per acre per season [0.76 lb
ai/acre]..

1 From approved existing master label.  Not included in proposed
supplemental label.

The label for 7969-247 (12.0% EC) has a maximum seasonal rate of 0.52 lb
ai/acre.  However, the directions state that no more than 80 oz of
Multiva™ should be applied per season, which is equivalent to 0.68 lb
ai.  The 80 oz is incorrect and must be changed to 62 oz of product.

Conclusions:  The submitted use directions are sufficient to allow for
evaluation of the submitted residue data relative to the proposed use
pattern.

860.1300 Nature of the Residue - Plants

HED MARC, DP# 278044, L. Cheng, 10/9/01

PP#0F6139, DP# 269668, L. Cheng, 11/28/01

Adequate metabolism studies with pyraclostrobin on grapes, potatoes, and
wheat have been reviewed (D269668, 11/28/01, L. Cheng) in conjunction
with PP#0F06139.  The results of these studies indicate that the
metabolism of pyraclostrobin is similar in the three crops investigated.
 The HED Metabolism Assessment Review Committee (MARC) discussed the
results of these studies on 9/20/01, and concluded that the nature of
the residue in plants is understood.  For the purpose of tolerance and
risk assessment, the terminal residues of concern in plants consist of
pyraclostrobin and its desmethoxy metabolite (BF 500-3).

860.1300 Nature of the Residue – Livestock

HED MARC, DP# 278044, L. Cheng, 10/9/01

PP#0F6139, DP# 269668, L. Cheng, 11/28/01

The nature of the residue in livestock is adequately understood based on
acceptable ruminant and poultry metabolism studies.  In goat, the major
residues are pyraclostrobin and BF 500-3 in muscle and fat;
pyraclostrobin, BF 500-3, and BF 500-5 and its sulfate conjugate in
milk; pyraclostrobin, BF 500-3, and BF 500-5 and its sulfate conjugate,
and hydroxylated desmethoxy metabolite (500M67) in kidney; and
metabolites hydrolyzed to BF 500-5 and its hydroxylated compound (BF
500-8) in liver.  In poultry, the major residues are pyraclostrobin and
BF 500-3 in eggs; pyraclostrobin, BF 500-3, and hydroxylated BF 500-3
(500M64) in fat; and the glucuronic acid conjugate of hydroxylated BF
500-3 (500M32) in liver.  Radioactive residues were below detection in
muscle.  The main degradation reactions in livestock consist of
demethoxylation, hydroxylation, and conjugation, and breaking of the
ether bond.

HED has determined that for the tolerance and risk assessment, the
residues of concern in livestock commodities consist of pyraclostrobin
and its metabolites convertible to 1-(4-chlorophenyl)-1H-pyrazol-3-ol
(BF 500-5) and 1-(4-chloro-2-hydroxyphenyl)-1H-pyrazol-3-ol (BF 500-8).

860.1340 Residue Analytical Methods

PP#0F6139, DP# 269668, L. Cheng, 11/28/01

PP#0F6139, DP# 269850, L. Cheng, 11/8/00

MRID: 48049201, W. Cutchin, in process

Enforcement:  Two adequate methods are available for enforcement
purposes for residues of pyraclostrobin and the metabolite BF 500-3
in/on plant commodities: an LC/MS/MS method (BASF Method D9908) and an
HPLC/UV method (Method D9904).  The validated method LOQ for both
pyraclostrobin and BF 500-3 is 0.02 ppm in all tested plant matrices,
for a combined LOQ of 0.04 ppm.  Adequate independent method validation
and radiovalidation data were submitted for both methods and forwarded
to Analytical Chemistry Branch/Biological and Economic Analysis Division
(ACB/BEAD) for a petition method validation.

388→194 for pyraclostrobin and m/z 358→164 for BF 500-3.

The LLMV in this study was 0.02 ppm for each of pyraclostrobin and BF
500-3.  Concurrent recoveries from fortifications of sugarcane at 0.02
and 20 ppm ranged from 76% to 110%.   Concurrent recoveries from
blackstrap molasses at the same fortifications ranged from 85 – 112%,
and for refined sugar, 85 – 101%  There were acceptable concurrent
method recovery data.

Conclusions: There are adequate residue analytical methods for tolerance
enforcement and data collection.

860.1360 Multiresidue Methods

PP#0F6139, DP# 269668, L. Cheng, 11/28/01

Pyraclostrobin was successfully evaluated through several of the FDA
protocols, while recovery of BF 500-3 was unsuccessful in all protocols.
 Pyraclostrobin was completely recovered through Protocol D (in grape)
and E (in grape), and partially recovered through Protocol F (in
peanut).  Metabolite BF 500-3 had poor peak shape and inadequate
sensitivity with Protocol C columns, and therefore was not further
analyzed under Protocol D, E, and F.  The results of the multiresidue
testing for pyraclostrobin were forwarded to FDA on 1/4/02 for the
purpose of updating the Pesticide Analytical Manual, Volume I (PAM I).

860.1380 Storage Stability

PP#0F6139, DP# 269668, L. Cheng, 11/28/01

Samples of sugar cane from the field trials were stored frozen (<-17
°C)  for up to 757 days (about 25 months).  Samples of processed
commodities were stored frozen (≤-12 °C) for up to 518 days (17
months).   Residues of pyraclostrobin and its metabolite BF 500-3 are
stable under frozen storage conditions in/on representative crop
commodities of grape juice, sugar beet tops and roots, tomatoes, and
wheat grain and straw for up to 25 months, and peanut nutmeat and
processed oil for up to 19 months.

Conclusions:  These data are adequate to support the storage conditions
and durations of samples from the sugarcane field trials and processing
study.

860.1400 Water, Fish, and Irrigated Crops

This guideline requirement is not relevant to the current petitions as
there are no aquatic uses being proposed for pyraclostrobin.

860.1460 Food Handling

This guideline requirement is not relevant to the current petitions as
there are no food-handling uses being proposed for pyraclostrobin.

860.1480 Meat, Milk, Poultry, and Eggs

Sugarcane blackstrap molasses is a carbohydrate concentrate (CC) feed
item for dairy cattle and beef cattle and may comprise up to 10% of the
diet of each.  The processing factor for conversion of sugarcane to
blackstrap molasses is 0.3X (S. Funk, 48237401.der2).  Applying that
factor to the HAFT for sugarcane (0.12 ppm, Table 4) yields a residue of
0.04 ppm on blackstrap molasses.  The contribution to the diet is 0.12 X
10% / 75%  DM = 0.02 ppm.  The dietary  exposure of cattle was most
recently determined to be 6.1 ppm for beef cattle and 12.9 ppm for dairy
cattle (D367409, 12/29/09, W. Cutchin).  Carbohydrate concentrates (CC)
contributed 2.56 ppm to the dairy diet and 1.0 ppm to the beef cattle
diet. These represent the maximum percentages allowed (80% CC for beef
cattle and 45% for dairy cattle). Sugarcane blackstrap molasses was
included in the calculation at a concentration of 0.4 ppm, based on the
temporary emergency tolerance.  It contributed minimally (0.03 ppm) to
the burden, and its contribution would now be less.  Therefore, no
significant changes to the dietary burden result from the present
considerations.  No changes to the existing livestock tolerances are
indicated.

Sugarcane blackstrap molasses is not a poultry or swine feed item.

860.1500 Crop Field Trials

MRID: 48237401

BASF Corp. has submitted field trial data for pyraclostrobin on
sugarcane.  A total of 8 crop field trials on sugarcane were conducted
in the United States during the 2008 growing season in North American
Free Trade Agreement (NAFTA) Growing Zones 3 (FL, 3 trials), 4 (LA, 4
trials), and 6 (TX).  Examination of the field trial records indicates
that one director supervised all three field trials in FL (all in the
same city), and another director supervised all field trials in both LA
(four in the same city) and the one trial approximately 600 miles
distant in TX.  Every crop field trial differed as to crop variety, and
the four trials in LA involved three different soil types.  Also, the
geographic area in which sugarcane is cultivated in the continental USA
is relatively small.   The trials are considered independent (n = 8) for
purposes of OSCPP 860.1500 data requirements.

Each trial consisted of one untreated (control) plot and one treated
plot.  At each trial location, the treated plots received four foliar
directed or foliar broadcast applications of a 2.09 lb ai/gal EC
formulation of pyraclostrobin (Headline®) during the vegetative or
bloom stages of development at rates of 0.189-0.206 lb ai/A/application
(0.21-0.23 kg ai/ha/application), for total seasonal rates of 0.78-0.81
lb ai/A (0.88-0.91 kg ai/ha).  RTIs were 13-14 days.  Applications were
made using ground equipment in spray volumes of 15.54-27.15 gal/A of
water (145-254 L/ha), containing 0.125-0.126% (v/v) of the NIS Silwet as
an adjuvant in all trials except for those in FL, which used no
adjuvant.  At two trial locations (Trial IDs 08-FL32 and 08-TX24)
designed to produce samples for processing, an additional plot received
four foliar directed or foliar broadcast applications of the Headline®
formulation of pyraclostrobin (Headline®) at rates of 0.977-1.04 lb
ai/A/application (1.09-1.13 kg ai/ha/application; 5x) beginning 56 days
prior to harvest during the vegetative or bloom stages, with RTIs of 13
or 14 days.   The total seasonal (5x) rates were 3.94-3.99 lb ai/A
(4.42-4.47 kg ai/ha).  Applications were made using ground equipment,
and the spray volumes were 21.65-22.32 gal/A of water (202-209 L/ha),
containing 0.125-0.128% (v/v) of the NIS Silwet as an adjuvant in the TX
trial; no adjuvant was used in the FL trial.  Samples of sugarcane were
harvested from all trials at PHIs of 13-14 and 27-28 days.

Samples of sugarcane were fortified with pyraclostrobin and BF 500-3 at
0.02 and 20 ppm.

The method was adequate for data collection based on acceptable
concurrent recovery data.  Recoveries were all within the acceptable
range of 70-120%.  The fortification levels used in concurrent method
recovery were adequate to bracket expected residue levels.  No residues
of pyraclostrobin or its metabolite BF 500-3 equal to or above the LLMV
were detected in any control samples.

Results are summarized in Table 4.

TABLE.4.	Summary of Residue Data from Crop Field Trials with
Pyraclostrobin.

Commodity	Total Applic. Rate

(lb ai/A)

[kg ai/ha]	PHI (days)	Analyte	Residue Levels1

 (ppm)

n	SampleMin.	Sample

Max.	LAFT2	HAFT2	Median	Mean	Std. Dev.

Sugarcane	0.78-0.81

(0.88-0.91)	13-14	Pyraclostro-bin	8	<0.02	0.1049	<0.02	0.099	0.058
<0.060	0.026

	BF 500-3	8	<0.02	0.0267	<0.02	0.027	<0.02	<0.021	0.002

	Combined	8	<0.04	<0.125	<0.040	<0.119	<0.076	<0.076	0.029

27-28	Pyraclostro-bin	8	<0.02	0.0866	<0.020	0.068	0.043	<0.044	0.016

	BF 500-3	8	<0.02	<0.02	<0.02	<0.02	<0.02	<0.02	N/A

	Combined	8	<0.04	<0.1066	<0.040	<0.088	<0.062	<0.061	0.017

Sugarcane

(for processing)	3.94-3.99

[4.42-4.47]	14	Pyraclostro-bin	2	0.0238	0.2935	0.028	0.255	0.141	0.141
N/A

	BF 500-3	2	<0.02	0.0253	<0.02	0.025	<0.022	<0.022	N/A

	Combined	2	<0.044	0.319	<0.048	0.280	<0.164	<0.164	N/A

28	Pyraclostro-bin	2	0.0203	0.38113	0.026	0.268	0.147	0.147	N/A

	BF 500-3	2	<0.02	0.0405	<0.02	<0.030	<0.025	<0.025	N/A

	Combined	2	<0.040	0.422	<0.046	<0.299	<0.172	<0.172	N/A

Conclusions:

The number and geographic distribution of the trials are adequate.  The
analytical method was demonstrated to be acceptable via concurrent
recoveries of fortified control samples.  The intervals of frozen
storage of samples are covered by previous storage stability studies,
and no corrections for loss of residue are needed.  The trials were
conducted according to the proposed label for the EC formulation (single
and seasonal application rates, PHI).  The results of the field trials
are acceptable for estimation of a sugarcane tolerance and for dietary
risk assessment purposes.

860.1520 Processed Food and Feed

PP#0F6139, DP# 269668, L. Cheng, 11/28/01

MRID 48237401

A processing study was submitted for sugarcane.  In a single sugarcane
field trial conducted in North American Free Trade Agreement (NAFTA)
Growing Zone 6 (TX) during the 2008 growing season, a 2.09 lb ai/gal
emulsifiable concentrate (EC) formulation of pyraclostrobin (Headline®)
was applied to sugarcane as four broadcast foliar applications at rates
of 0.977-0.993 lb ai/A/application (1.09-1.11 kg ai/ha/application;
reported 5x rate) beginning 53 days prior to harvest during the
vegetative stage, with a retreatment interval (RTI) of 13 days.  The
total seasonal rate was 3.94 lb ai/A (4.42 kg ai/ha; 5x).

Bulk samples of sugarcane were harvested 14 days after the last
application.  Sugarcane was processed within 21-27 days of harvest into
blackstrap molasses and refined sugar using simulated commercial
procedures.

Samples of sugarcane cane and processed sugarcane commodities were
analyzed for residues of pyraclostrobin and its metabolite BF 500-3
using a liquid chromatography method with tandem mass spectrometry
detection (LC/MS/MS), Method D9908 (Version II).  Samples of sugarcane
RAC, blackstrap molasses, and refined sugar were fortified with
pyraclostrobin and BF 500-3 at 0.02 and 20 ppm.  The method was adequate
for data collection based on acceptable concurrent recovery data.
Recoveries were all within the acceptable range of 70-120%.

Results are summarized in Table 5.

Table 5	Residue Data from Sugarcane Processing Study with
Pyraclostrobin.

Sugarcane Commodity	Total Rate

(lb ai/A)

[kg ai/A]	PHI

(days)	Residues (ppm)1	Processing Factor

	Pyraclostrobin	BF 500-32	Combined2

	Sugarcane RAC	3.94

[4.42]	14	0.232	0.033	0.265	--

Blackstrap molasses

	0.057	<0.02	<0.077	<0.29x

Refined sugar

	<0.02	<0.02	<0.04	<0.15x

1 The petitioner used the lowest level of method validation (LLMV) of
0.02 ppm as the limit for reporting residues for both pyraclostrobin and
its metabolite BF 500-3.  For determining the combined residues, the
LLMV was used for values reported as <LLMV.

2 Residues of metabolite BF 300-3 were reported in parent equivalents.

Conclusions:

The submitted sugarcane processing study is adequate.  An acceptable
method was used for quantitation of pyraclostrobin and BF 500-3 residues
in sugarcane RAC and sugarcane processed commodities.  Samples were
stored frozen for intervals covered by the storage stability study.

Residues of pyraclostrobin and BF 500-3 did not concentrate in
blackstrap molasses or refined sugar, relative to the concentration in
the raw agricultural commodity (sugarcane).  Therefore, tolerances are
not necessary for these processed commodities.

860.1650 Submittal of Analytical Reference Standards

Analytical reference standards for pyraclostrobin and regulated
metabolites (BF 500-3; BF 500-5; BF 500-8) are currently available in
the EPA National Pesticide Standards Repository (e-mail correspondence
with T. Cole, 01/14/2013).

860.1850 Confined Accumulation in Rotational Crops

MARC, DP# 278044, L. Cheng, 10/9/01

PP#0F6139, DP# 269668, L. Cheng, 11/28/01

An adequate confined rotational crop study was reviewed in PP#0F6139.
The study showed that the metabolism of pyraclostrobin in rotated crops
is similar but more extensive than that in primary crops.
Pyraclostrobin undergoes demethoxylation to yield BF 500-3, followed by
further degradation to medium polar and polar metabolites, and
subsequent conjugation reactions and incorporation into natural
products.  The HED MARC has determined that the residues of concern in
rotational crops consist of pyraclostrobin and metabolite BF 500-3.

860.1900 Field Accumulation in Rotational Crops

PP#0F6139, DP# 269668, L. Cheng, 11/28/01

A limited field rotational crop study was reviewed in PP#0F6139.  The
results indicate that r  SEQ CHAPTER \h \r 1 esidues of pyraclostrobin
and its metabolite BF 500-3 were each less than the method LOQ (<0.02
ppm) in/on rotational crop matrices (radish, roots and tops; cabbage,
with and without wrapper leaves; and wheat forage, hay, and grain)
planted 14 days following the last of six sequential foliar applications
to the primary crop, cucumbers, of the 2 lb/gal EC formulation at 0.19 -
0.20 lb ai/A/application.  Residues of pyraclostrobin in/on one sample
of wheat straw from the CA test site were at the LOQ (0.02 ppm), but
residues of pyraclostrobin in/on a replicate sample from the same plot
were below the LOQ (0.012 ppm) for an average residue of <0.02 ppm.
Residues of metabolite BF 500-3 were nondetectable (<0.02 ppm) in/on all
samples of wheat straw.

The registered pyraclostrobin end-use product labels presently specify a
14-day plantback interval restriction for all crops that are not
registered.

860.1550 Proposed Tolerances

For the use of pyraclostrobin on sugarcane a tolerance is required.   A
time-limited Section 18 tolerance of 0.02 ppm exists (40 CFR
§180.582(b).  Based on evaluation of the sugarcane field trial data
with the Organization for Economic Cooperation and Development (OECD)
tolerance calculation procedure, a tolerance of 0.2 ppm is appropriate
for sugarcane, cane (see Appendix I).

Codex and Canada have not established MRLs for pyraclostrobin on
sugarcane.  Therefore, there is no issue of harmonization.

Pyraclostrobin residues did not concentrate in sugarcane molasses and
sugarcane refined sugar.  Therefore these commodities are covered by the
tolerance for the raw agricultural commodity, sugarcane, cane.

The recommended tolerances for sugarcane commodities is  presented in
Table 6.

Table 6.		Tolerance Summary for Pyraclostrobin.

Commodity	Proposed/Existing Tolerance (ppm)	Recommended/ Harmonized
Tolerance (ppm)	Comments; Correct Commodity Definition

40 CFR §180.582(a) It is recommended that a tolerance be established
for residues of the fungicide pyraclostrobin, including its metabolites
and degradates, as indicated below . Compliance with the tolerance
levels is to be determined by measuring only the sum 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]phenyl carbamate),
calculated as the stoichiometric  equivalent of pyraclostrobin

Sugarcane, cane 	0.2	0.20	-

40 CFR §180.582(b) Section 18 emergency exemptions

Sugarcane, cane	0.02	Revoke	Replaced with new tolerance in (a)

Sugarcane, molasses	0.40	Revoke	Replaced with new tolerance in (a) for
sugarcane, cane

References

DP#s:	367409

Subject:	Pyraclostrobin.  Petition for New Uses and Tolerances on
Alfalfa.  Summary of Analytical Chemistry and Residue Data.

From:	W. Cutchin

To:	T. Kish/J. Bazuin

Dated:	10/19/09

MRIDs:	47584401

DP#s:	281042, 286732, 287729, 288459, 290342, 290343, 290369, 292440,
293088, 293684, 295893, 298178

Subject:	Pyraclostrobin.  PP#3F06581, 2F06431, 2E6473, 3E6548, 3E6553,
3E6774, and 2F06139.  Petitions for the establishment of permanent
tolerances to allow uses on corn (field, sweet, and pop), hops, mint,
pome fruits, edible-podded legume vegetables, succulent peas, sunflower,
Brassica leafy greens, soybeans, succulent beans, broccoli, cabbage,
lettuce (head and leaf), spinach, celery, turnip greens, and the import
commodities mango and papaya.  Application for amended Section 3
registration for citrus (reduced PHI).  Petitioner’s response to data
deficiencies identified in PP#0F06139 regarding storage stability data,
dried shelled peas and beans (reduced PHI), and uses on dry and
succulent peas.  Summary of Analytical Chemistry and Residue Data.

From:	L. Cheng

To:	C. Giles-Parker/J. Bazuin

Dated:	7/26/04

MRIDs:	45596211, 45623406, 45623407, 45623408, 45623410, 45645801,
45645802, 45645803, 45645804, 45702901, 45765401, 45832001, 45858801,
45858802, 45903601, 45903602, 46033901-04, 46084401-04, 46109101,
46109102

DP#s:	269668, 272771, 272789, 274095, 274192, 274471, 274957, 275843,
and 278429

Subject:	PP#0F06139.  Pyraclostrobin on Various Crops:  Bananas
(import), Barley, Berries, Bulb Vegetables, Citrus Fruits, Cucurbit
Vegetables, Dried Shelled Pea & Bean (except Soybean), Fruiting
Vegetables, Grapes, Grass, Peanut, Pistachio, Root Vegetables (except
Sugar Beet), Rye, Snap Beans, Stone Fruits, Strawberry, Sugar Beet, Tree
Nuts, Tuberous and Corm Vegetables, and Wheat.  Review of Analytical
Methods and Residue Data.

From:	L. Cheng

To:	C. Giles-Parker/J. Bazuin

Dated:	11/28/01

MRIDs:	45118428-451184-37, 45118501-45118512, 45118514-45118537,
45118601-45118625, 45160501, 45272801, 45274901, 45321101, 45367501,
45399401, and 45429901

DP#:	278044

Subject:	PP# 0F06139.  PC Code 099100.  Pyraclostrobin.  Outcome of the
HED Metabolism Assessment Review Committee (MARC) Meeting Held on
September 20, 2001.

From:	L. Cheng

To:	Y. Donovan

Dated:	10/09/01

MRIDs:	None

DP#:	269850

Subject:	PP# 0F06139.  Pyraclostrobin (BAS 500F) in or on Various Crops.
Request for Tolerance Method Validation (TMV) Trial.

From:	L. Cheng

To:	F. D. Griffith, Jr.

Dated:	11/8/00

MRIDs:	45118505, 45118504, 45118509, 45118510, 45118501, 45118503,
45118507, 45118514

DP#:	281042, 286732, 287729, 288459, 290342, 290343, 290369, 292440,
293088, 293684, 295893, 298178

Subject:	Pyraclostrobin.  PP#3F06581, 2F06431, 2E6473, 3E6548, 3E6553,
3E6774, and 2F06139.  Petitions for the establishment of permanent
tolerances to allow uses on corn (field, sweet, and pop), hops, mint,
pome fruits, edible-podded legume vegetables, succulent peas, sunflower,
Brassica leafy greens, soybeans, succulent beans, broccoli, cabbage,
lettuce (head and leaf), spinach, celery, turnip greens, and the import
commodities mango and papaya.  Application for amended Section 3
registration for citrus (reduced PHI).  Petitioner’s response to data
deficiencies identified in PP#0F06139 regarding storage stability data,
dried shelled peas and beans (reduced PHI), and uses on dry and
succulent peas.  Summary of Analytical Chemistry and Residue Data.

From:	L. Cheng

To:	Cynthia Giles-Parker

Dated:	7/26/04

MRIDs:	45596211, 45623406, 45623407, 45623408, 45623410, 45645801,
45645802, 45645803, 45645804, 45702901, 45765401, 45832001, 45858801,
45858802, 45903601, 45903602, 46033901-04, 46084401-04, 46109101,
46109102

International Residue Limits

Pyraclostrobin (099100; 01/31/2013)

Summary of US and International Tolerances and Maximum Residue Limits

Residue Definition:

US	Canada	Mexico2	Codex3

40 CFR §180.582.  Plants:  Tolerances are established for residues of
the fungicide pyraclostrobin, including its metabolites and degradates.
Compliance with the tolerance levels is to be determined by measuring on
the sum 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]phenyl carbamate),
calculated as the stoichiometric  equivalent of pyraclostrobin	methyl
[2-[[[1-(4-chlorophenyl)-1H-pyrazol-3-yl]oxy]methyl]phenyl]methoxycarbam
ate, including the metabolite [2-[[[1-(4-chlorophenyl)-1H-pyrazol-3-

yl]oxy]methyl]phenyl]carbamate	-	Pyraclostrobin.  Residue is NOT fat
soluble.

Commodity1	Tolerance (ppm) /Maximum Residue Limit (ppm)

	US	Canada	Mexico2	Codex3

Sugarcane, cane	0.2	None

None

1 Includes only commodities of interest for this action.  Tolerance
values should be the HED recommendations and not those proposed by the
applicant.

2 Mexico adopts US tolerances and/or Codex MRLs for its export purposes.

3 * = absent at the limit of quantitation; Po = postharvest treatment,
such as treatment of stored grains.  PoP = processed postharvest treated
commodity, such as processing of treated stored wheat. (fat) = to be
measured on the fat portion of the sample. MRLs indicated as proposed
have not been finalized by the CCPR and the CAC.

Appendix I:  Determination of Tolerance for Pyraclostrobin in/on
Sugarcane and Its Processed Fractions

The Organization of Economic Cooperation and Development statistical
procedure was used to calculate a tolerance estimate for sugarcane.  The
estimate agreed with the proposal of BASF.

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؀Ĥ摧⿙Æ฀Sugarcane

USA

0.80 lb ai/A, PHI 14 day

Total number of data (n)	8

Percentage of censored data	25%

Number of non-censored data	6

Lowest residue	0.040

Highest residue	0.119

Median residue	0.076

Mean	0.076

Standard deviation (SD)	0.029

Correction factor for censoring (CF)	0.833

Proposed MRL estimate

- Highest residue	0.119

- Mean + 4 SD	0.191

- CF x 3 Mean	0.190

Unrounded MRL	0.191

Rounded MRL	0.2

Residues (mg/kg)	n

 < 0.04 	2

0.068	1

0.073	1

0.078	1

0.079	1

0.112	1

0.119	1

Pyraclostrobin

Sugarcane

USA

0.80 lb ai/A, 28 day

Total number of data (n)	8

Percentage of censored data	25%

Number of non-censored data	6

Lowest residue	0.040

Highest residue	0.088

Median residue	0.062

Mean	0.061

Standard deviation (SD)	0.017

Correction factor for censoring (CF)	0.833

Proposed MRL estimate

- Highest residue	0.088

- Mean + 4 SD	0.131

- CF x 3 Mean	0.153

Unrounded MRL	0.153

Rounded MRL	0.15

Residues (mg/kg)	n

 < 0.04 	2

0.05	1

0.06	1

0.063	1

0.074	1

0.076	1

0.088	1

Processed Commodities

Pyraclostrobin and BF 500-3 declined in concentration from the raw
agricultural commodity (RAC) to refined sugar and blackstrap molasses
processed products.  Therefore, the tolerance for sugarcane will cover
the processed commodities.  No separate tolerances are needed.

Pyraclostrobin		D403449

Page   PAGE  1  of   NUMPAGES   9


[Federal Register: March 18, 2010 (Volume 75, Number 52)]
[Rules and Regulations]
[Page 12974-12975]
[DOCID:fr18mr10-8]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2009-0954; Airspace Docket No. 09-ANM-11]

Establishment of Class E Airspace; Hailey, ID

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: This action will establish Class E airspace at Hailey, ID, to
accommodate aircraft using the Area Navigation (RNAV) Global
Positioning System (GPS) Standard Instrument Approach Procedure (SIAP)
at Friedman Memorial Airport. This will improve the safety of
Instrument Flight Rules (IFR) operations at the airport.

DATES: Effective Date: 0901 UTC, June 3, 2010. The Director of the
Federal Register approves this incorporation by reference action under
1 CFR part 51, subject to the annual revision of FAA Order 7400.9 and
publication of conforming amendments.

FOR FURTHER INFORMATION CONTACT: Eldon Taylor, Federal Aviation
Administration, Operations Support Group, Western Service Center, 1601
Lind Avenue, SW., Renton, WA 98057; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

History

    On December 15, 2009, the FAA published in the Federal Register a
notice of proposed rulemaking to establish additional controlled
airspace at Hailey, ID (74 FR 66258). Interested parties were invited
to participate in this rulemaking effort by submitting written comments
on the proposal to the FAA. No comments were received.
    Class E airspace designations are published in paragraph 6002 of
FAA Order 7400.9T signed August 27, 2009, and effective September 15,
2009, which is incorporated by reference in 14 CFR part 71.1. The Class
E airspace designations listed in this document will be published
subsequently in that Order.

The Rule

    This action amends Title 14 Code of Federal Regulations (14 CFR)
part 71 by establishing Class E surface airspace for the Hailey, ID,
area to accommodate IFR aircraft executing a new RNAV (GPS) SIAPs at
Friedman Memorial Airport. This action is necessary for the safety and
management of IFR operations at the airport.
    The FAA has determined this regulation only involves an established
body of technical regulations for which frequent and routine amendments
are necessary to keep them operationally current. Therefore, this
regulation: (1) Is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under DOT
Regulatory Policies and Procedures (44 FR 11034; February 26, 1979);
and (3) does not warrant preparation of a regulatory evaluation as the
anticipated impact is so minimal. Since this is a routine matter that
will only affect air traffic procedures and air navigation, it is
certified that this rule, when promulgated, will not have a significant
economic impact on a substantial number of small entities under the
criteria of the Regulatory Flexibility Act. The FAA's authority to
issue rules regarding aviation safety is found in Title 49 of the U.S.
Code. Subtitle 1, Section 106 discusses the authority of the FAA
Administrator. Subtitle VII, Aviation Programs, describes in more
detail the scope of the agency's authority. This rulemaking is
promulgated under the authority described in Subtitle VII, Part A,
Subpart I, Section 40103. Under that section, the FAA is charged with
prescribing regulations to assign the use of airspace necessary to
ensure the safety of aircraft and the efficient use of airspace. This
regulation is within the scope of that authority as it establishes
additional controlled airspace at Friedman Memorial Airport, Hailey,
ID.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

Adoption of the Amendment

0
In consideration of the foregoing, the Federal Aviation Administration
amends 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for 14 CFR part 71 continues to read as
follows:

    Authority: 49 U.S.C. 106(g), 40103, 40113, 40120; E. O. 10854,
24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of the Federal
Aviation Administration Order 7400.9T, Airspace Designations and
Reporting Points, signed August 27, 2009, and effective September 15,
2009 is amended as follows:

Paragraph 6002 Class E airspace designated as surface areas.

* * * * *

ANM ID E2 Hailey, ID [New]

Friedman Memorial Airport, ID
    (Lat. 43[deg]30[min]14[sec] N., long. 114[deg]17[min]44[sec] W.)

    Within a 4.1-mile radius of the Friedman Memorial Airport, and
within 1.8 miles each side of the 159[deg] bearing from the airport,
extending from the 4.1-mile radius to 6 miles southeast of the
airport. This Class E airspace area is effective during the specific
dates and times established in advance by a Notice to Airmen. The
effective dates and times will thereafter be continuously published
in the Airport/Facility Directory.

    Issued in Seattle, Washington, on March 3, 2010.
Clark Desing,
Manager, Operations Support Group, Western Service Center.
[FR Doc. 2010-5604 Filed 3-17-10; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 82, Number 49 (Wednesday, March 15, 2017)]
[Notices]
[Pages 13823-13824]
[FR Doc No: 2017-05188]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-1063]

Oncologic Drugs Advisory Committee; Notice of Meeting;
Establishment of a Public Docket; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; establishment of a public docket; request for comments.

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

SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming
public advisory committee meeting of the Oncologic Drugs Advisory
Committee. The general function of the committee is to provide advice
and recommendations to the Agency on FDA's regulatory issues. The
meeting will be open to the public. FDA is establishing a docket for
public comment on this document.

DATES: The meeting will be held on March 29, 2017, from 8 a.m. to 5
p.m. Submit either electronic or written comments on this document by
March 28, 2017. Late, untimely filed comments will not be considered.
Electronic comments must be submitted on or before March 28, 2017. The
https://www.regulations.gov electronic filing system will accept
comments until midnight Eastern Time at the end of March 28, 2017.
Comments received by mail/hand delivery/courier (for written/paper
submissions) will be considered timely if they are postmarked or the
delivery service acceptance receipt is on or before that date.

ADDRESSES: Sheraton College Park North Hotel, Chesapeake Ballroom, 4095
Powder Mill Road, Beltsville, MD 20705. The hotel's telephone number is
301-937-4422. Answers to commonly asked questions including information
regarding special accommodations due to a disability, visitor parking,
and transportation may be accessed at: http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.
    You may submit comments as follows:

Electronic Submissions

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Follow the instructions for submitting comments. Comments submitted
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     If you want to submit a comment with confidential
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submit the comment as a written/paper submission and in the manner
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    Submit written/paper submissions as follows:
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    Instructions: All submissions received must include the Docket No.
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Received comments, those filed in a timely manner (see DATES), will be
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Submit

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    Docket: For access to the docket to read background documents or
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FOR FURTHER INFORMATION CONTACT: Lauren D. Tesh, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301-
796-9001, FAX:<PHONE_NUMBER>, email<EMAIL_ADDRESS>or FDA Advisory
Committee Information Line, 1-800-741-8138<PHONE_NUMBER> in the
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at http://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to
the appropriate advisory committee meeting link, or call the advisory
committee information line to learn about possible modifications before
coming to the meeting.

SUPPLEMENTARY INFORMATION:
    Agenda: During the morning session of March 29, 2017, the committee
will discuss biologics license application (BLA) 761064, rituximab/
hyaluronidase injection for subcutaneous use, submitted by Genentech,
Inc. The proposed indications (uses) for this product are for: (1) The
treatment of patients with relapsed or refractory, follicular lymphoma
as a single agent; (2) previously untreated follicular lymphoma in
combination with first line chemotherapy and, in patients achieving a
complete or partial response to rituximab/hyaluronidase for
subcutaneous injection in combination with chemotherapy, as single-
agent maintenance therapy; (3) non-progressing (including stable
disease), follicular lymphoma as a single agent after first-line
cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy; (4)
the treatment of patients with previously untreated diffuse large B-
cell lymphoma (DLBCL) in combination with cyclophosphamide,
doxorubicin, vincristine, prednisolone (CHOP) or other anthracycline
based chemotherapy regimens; and (5) in combination with fludarabine
and cyclophosphamide (FC), for the treatment of patients with
previously untreated and previously treated chronic lymphocytic
leukemia (CLL). During the afternoon session, the committee will
discuss new drug application (NDA) 209099, for binimetinib, submitted
by Array BioPharma Inc. The proposed indication (use) for this product
is for the treatment of patients with unresectable or metastatic
melanoma, with NRAS Q61 mutation as detected by an FDA-approved test,
who have received prior treatment with checkpoint inhibitor therapy.
    FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its Web site prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's Web site after the meeting. Background material is
available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting
link.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
All electronic and written submissions submitted to the Docket (see the
ADDRESSES section) on or before March 24, 2017, will be provided to the
committee. Oral presentations from the public will be scheduled between
approximately 10:30 a.m. to 11 a.m., and 3:30 p.m. to 4 p.m. Those
individuals interested in making formal oral presentations should
notify the contact person and submit a brief statement of the general
nature of the evidence or arguments they wish to present, the names and
addresses of proposed participants, and an indication of the
approximate time requested to make their presentation on or before
March 21, 2017. Time allotted for each presentation may be limited. If
the number of registrants requesting to speak is greater than can be
reasonably accommodated during the scheduled open public hearing
session, FDA may conduct a lottery to determine the speakers for the
scheduled open public hearing session. The contact person will notify
interested persons regarding their request to speak by March 22, 2017.
    Persons attending FDA's advisory committee meetings are advised
that the Agency is not responsible for providing access to electrical
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    FDA is establishing a docket for public comment on this meeting.
The docket number is FDA-2017-N-1063. The docket will close on March
28, 2017. Comments received on or before March 24, 2017, will be
provided to the committee. Comments received after that date will be
taken into consideration by the Agency.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
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the meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: March 10, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-05188 Filed 3-14-17; 8:45 am]
BILLING CODE 4164-01-P