[Federal Register Volume 80, Number 55 (Monday, March 23, 2015)]
[Rules and Regulations]
[Page 15167]
[FR Doc No: 2015-06603]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 100

[Docket No. USCG-2015-0062]

Special Local Regulation; Annual Marine Events on the Colorado
River, Between Davis Dam (Bullhead City, Arizona) and Headgate Dam
(Parker, Arizona) Within the San Diego Captain of the Port Zone

AGENCY: Coast Guard, DHS.

ACTION: Notice of enforcement of regulation.

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SUMMARY: The Coast Guard will enforce the 2015 Lake Havasu Desert Storm
marine event special local regulations from 8 a.m. through 3 p.m. on
April 25, 2015. This annual marine event occurs on the navigable waters
of the Colorado River in Lake Havasu, Arizona. This action is necessary
to provide for the safety of the participants, crew, spectators, safety
vessels, and general users of the waterway. During the enforcement
period, persons and vessels are prohibited from entering into,
transiting through, or anchoring within this regulated area unless
authorized by the Captain of the Port, or his designated
representative.

DATES: The regulations in 33 CFR 100.1102, Table 1, Item 4 will be
enforced from 8 a.m. through 3 p.m. on April 25, 2015. If the event is
delayed by inclement weather, these regulations will also be enforced
from 8 a.m. through 3 p.m. on April 26, 2015.

FOR FURTHER INFORMATION CONTACT: If you have questions on this
document, call or email Petty Officer Nick Bateman, Waterways
Management, U.S. Coast Guard Sector San Diego, CA; telephone 619-278-
7656<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The Coast Guard will enforce the Special
Local Regulations in Lake Havasu for the 2015 Desert Storm Shootout in
33 CFR 100.1102, Table 1, Item 4 from 8 a.m. through 3 p.m. on April
25, 2015. If the event is delayed by inclement weather, these
regulations will also be enforced from 8 a.m. through 3 p.m. on April
26, 2015.
    Under provisions of 33 CFR 100.1102, persons and vessels are
prohibited from entering into, transiting through, or anchoring within
the regulated area, unless authorized by the Coast Guard Captain of the
Port or his designated representative. Persons or vessels desiring to
enter into or pass through the special local regulations may request
permission from the Captain of the Port or a designated representative.
If permission is granted, all persons and vessels shall comply with the
instructions of the Captain of the Port or his designated
representative. Spectator vessels may safely transit outside the
regulated area but may not anchor, block, loiter, or impede the transit
of participants or official patrol vessels. The Coast Guard may be
assisted by other Federal, State, or Local law enforcement agencies in
enforcing this regulation.
    This document is issued under authority of 33 CFR 100.1102 and 5
U.S.C. 552(a). In addition to this document in the Federal Register,
the Coast Guard will provide the maritime community with extensive
advance notification of this enforcement period via the Local Notice to
Mariners, Broadcast Notice to Mariners, and local advertising by the
event sponsor.
    If the Captain of the Port Sector San Diego or his designated
representative determines that the regulated area need not be enforced
for the full duration stated on this document, he or she may use a
Broadcast Notice to Mariners to grant general permission to enter the
regulated area.

     Dated: March 6, 2015.
J.A. Janszen,
Commander, U.S. Coast Guard, Acting, Captain of the Port San Diego.
[FR Doc. 2015-06603 Filed 3-20-15; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 76, Number 149 (Wednesday, August 3, 2011)]
[Notices]
[Pages 46791-46793]
[FR Doc No: 2011-19626]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings 1

    Take notice that the Commission received the following exempt
wholesale generator filings:
    Docket Numbers: EG11-114-000.
    Applicants: TPW Petersburg, LLC.
    Description: Self-Certification of Exempt Wholesale Generator
Status of TPW Petersburg, LLC.
    Filed Date: 07/26/2011.
    Accession Number: 20110726-5110.
    Comment Date: 5 p.m. Eastern Time on Tuesday, August 16, 2011.

    Take notice that the Commission received the following electric
rate filings:
    Docket Numbers: ER11-3795-001.
    Applicants: Interstate Power and Light Company.
    Description: Interstate Power and Light Company submits tariff
filing per 35.17(b): IPL & Elk Wind Energy--LBA Agreement Amendment to
be effective 6/14/2011.
    Filed Date: 07/26/2011.
    Accession Number: 20110726-5037.
    Comment Date: 5 p.m. Eastern Time on Tuesday, August 16, 2011.

    Docket Numbers: ER11-3800-001.
    Applicants: Interstate Power and Light Company.
    Description: Interstate Power and Light Company submits tariff
filing per 35.17(b): IPL & Lakefield Wind Project--LBA Agreement
Amendment to be effective 6/15/2011.
    Filed Date: 07/26/2011.
    Accession Number: 20110726-5038.
    Comment Date: 5 p.m. Eastern Time on Tuesday, August 16, 2011.

    Docket Numbers: ER11-4102-001.
    Applicants: Public Service Company of New Mexico.
    Description: Public Service Company of New Mexico submits tariff
filing per 35: OATT Section 23 Revision 2 Substitute to be effective 9/
21/2011.
    Filed Date: 07/26/2011.
    Accession Number: 20110726-5001.
    Comment Date: 5 p.m. Eastern Time on Tuesday, August 16, 2011.

    Docket Numbers: ER11-4112-000.
    Applicants: Southwestern Electric Power Company.
    Description: Southwestern Electric Power Company submits tariff
filing per 35.13(a)(2)(iii: 20110726 Rayburn PSA to be effective 12/17/
2010.
    Filed Date: 07/26/2011.
    Accession Number: 20110726-5040.
    Comment Date: 5 p.m. Eastern Time on Tuesday, August 16, 2011.

    Docket Numbers: ER11-4113-000.
    Applicants: Constellation NewEnergy, Inc.
    Description: Constellation NewEnergy, Inc. submits tariff filing
per 35.13(a)(2)(iii: Revised MBR Tariff Effective 7-27-2011 to be
effective 7/27/2011.
    Filed Date: 07/26/2011.
    Accession Number: 20110726-5046.
    Comment Date: 5 p.m. Eastern Time on Tuesday, August 16, 2011.

    Docket Numbers: ER11-4114-000.
    Applicants: Pacific Gas and Electric Company.
    Description: Pacific Gas and Electric Company submits tariff filing
per 35.13(a)(2)(iii: Modifications to Remove the RMS Agreement from
LGIA, Attachment H to WD Tariff to be effective 9/30/2011.
    Filed Date: 07/26/2011.
    Accession Number: 20110726-5062.
    Comment Date: 5 p.m. Eastern Time on Tuesday, August 16, 2011.

    Docket Numbers: ER11-4115-000.
    Applicants: Michigan Electric Transmission Company, LLC.
    Description: Michigan Electric Transmission Company, LLC submits
tariff filing per 35.13(a)(2)(iii: Notice of Succession to Transmission
Agreement with County of Antrim to be effective 9/26/2011.
    Filed Date: 07/26/2011.
    Accession Number: 20110726-5065.
    Comment Date: 5 p.m. Eastern Time on Tuesday, August 16, 2011.

    Docket Numbers: ER11-4116-000.
    Applicants: Michigan Electric Transmission Company, LLC.
    Description: Michigan Electric Transmission Company, LLC submits
tariff filing per 35.13(a)(2)(iii: Filing of Amended and Restated
Facilities Agreement to be effective 9/26/2011.
    Filed Date: 07/26/2011.
    Accession Number: 20110726-5068.
    Comment Date: 5 p.m. Eastern Time on Tuesday, August 16, 2011.

    Docket Numbers: ER11-4117-000.
    Applicants: Michigan Electric Transmission Company, LLC.
    Description: Michigan Electric Transmission Company, LLC submits
tariff filing per 35.13(a)(2)(iii: Filing of Amended and Restated
Marshall Facilities Agreement to be effective 9/26/2011.
    Filed Date: 07/26/2011.
    Accession Number: 20110726-5077.
    Comment Date: 5 p.m. Eastern Time on Tuesday, August 16, 2011.

    Docket Numbers: ER11-4118-000.
    Applicants: Michigan Electric Transmission Company, LLC.
    Description: Michigan Electric Transmission Company, LLC submits
tariff filing per 35.13(a)(1): Filing of Letter Agreement with MSCPA to
be effective 9/26/2011.
    Filed Date: 07/26/2011.
    Accession Number: 20110726-5082.
    Comment Date: 5 p.m. Eastern Time on Tuesday, August 16, 2011.

    Docket Numbers: ER11-4119-000.
    Applicants: Michigan Electric Transmission Company, LLC.
    Description: Michigan Electric Transmission Company, LLC submits
tariff filing per 35.13(a)(1): Filing of Letter Agreement with Presque
Isle County to be effective 9/26/2011.
    Filed Date: 07/26/2011.
    Accession Number: 20110726-5085.
    Comment Date: 5 p.m. Eastern Time on Tuesday, August 16, 2011.

    Docket Numbers: ER11-4120-000.
    Applicants: FFC Energy, LLC.
    Description: FFC Energy, LLC submits tariff filing per 35.12: FFC
Market Based Rate Tariff to be effective 9/30/2011.
    Filed Date: 07/26/2011.
    Accession Number: 20110726-5093.
    Comment Date: 5 p.m. Eastern Time on Tuesday, August 16, 2011.

    Docket Numbers: ER11-4121-000.
    Applicants: ALLETE, Inc., Midwest Independent Transmission System
Operator, Inc.
    Description: ALLETE, Inc. submits tariff filing per
35.13(a)(2)(iii: Allete-Bison LGIAs to be effective 7/27/2011.
    Filed Date: 07/26/2011.
    Accession Number: 20110726-5129.
    Comment Date: 5 p.m. Eastern Time on Tuesday, August 16, 2011.

    Docket Numbers: ER11-4121-000.
    Applicants: ALLETE, Inc., Midwest Independent Transmission System
Operator, Inc.
    Description: ALLETE, Inc. submits tariff filing per
35.13(a)(2)(iii: Allete-Bison LGIAs to be effective 7/27/2011.
    Filed Date: 07/26/2011.
    Accession Number: 20110726-5130.
    Comment Date: 5 p.m. Eastern Time on Tuesday, August 16, 2011.

    Docket Numbers: ER11-4125-000.
    Applicants: Xcel Energy Services Inc., Southwestern Public Service
Company.
    Description: Southwestern Public Service Company's Notice of
Termination of Master Commodity Purchase and Sale Agreement with
Reliant Energy Service, Inc.
    Filed Date: 07/27/2011.
    Accession Number: 20110727-5044.
    Comment Date: 5 p.m. Eastern Time on Wednesday, August 17, 2011.

    Take notice that the Commission received the following land
acquisition reports:
    Docket Numbers: LA11-2-000.
    Applicants: CinCap IV, LLC, CinCap V, LLC, Duke Energy Commercial
Asset Management, Inc., Duke Energy Commercial Enterprises, Inc., Duke
Midwest Operating Companies, Duke Energy Carolinas, LLC, Duke Energy
Fayette II, LLC, Duke Energy Hanging Rock II, LLC, Duke Energy Indiana,
Inc., Duke Energy Kentucky, Inc., Duke Energy Lee II, LLC., Duke Energy
Ohio, Inc., Duke Energy Retail Sales, LLC, Duke Energy Trading and
Marketing, LLC, Duke Energy Vermillion II, LLC, Duke Energy Washington
II, LLC, Happy Jack Windpower, LLC, North Allegheny Wind, LLC, Silver
Sage Windpower, LLC, St. Paul Cogeneration, LLC, Three Buttes
Windpower, LLC, Kit Carson Windpower, LLC, Top of the World Energy,
LLC.
    Description: Report of Duke Energy Corporation under LA11-2.
    Filed Date: 07/26/2011.
    Accession Number: 20110726-5149.
    Comment Date: 5 p.m. Eastern Time on Tuesday, August 16, 2011.
    Any person desiring to intervene or to protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Rules of Practice and Procedure (18 CFR 385.211 and
385.214) on or before 5 p.m. Eastern time on the specified comment
date. It is not necessary to separately intervene again in a subdocket
related to a compliance filing if you have previously intervened in the
same docket. Protests will be considered by the Commission in
determining the appropriate action to be taken, but will not serve to
make protestants parties to the proceeding. Anyone filing a motion to
intervene or protest must serve a copy of that document on the
Applicant. In reference to filings initiating a new proceeding,
interventions or protests submitted on or before the comment deadline
need not be served on persons other than the Applicant.
    As it relates to any qualifying facility filings, the notices of
self-certification [or self-recertification] listed above, do not
institute a proceeding regarding qualifying facility status. A notice
of self-certification [or self-recertification] simply provides
notification that the entity making the filing has determined the
facility named in the notice meets

the applicable criteria to be a qualifying facility. Intervention and/
or protest do not lie in dockets that are qualifying facility self-
certifications or self-recertifications. Any person seeking to
challenge such qualifying facility status may do so by filing a motion
pursuant to 18 CFR 292.207(d)(iii). Intervention and protests may be
filed in response to notices of qualifying facility dockets other than
self-certifications and self-recertifications.
    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
14 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First St., NE., Washington, DC 20426.
    The filings in the above proceedings are accessible in the
Commission's eLibrary system by clicking on the appropriate link in the
above list. They are also available for 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 e-mail notification
when a document is added to a subscribed docket(s). For assistance with
any FERC Online service, please e-mail<EMAIL_ADDRESS>or
call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.

    Dated: July 27, 2011.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2011-19626 Filed 8-2-11; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 77, Number 247 (Wednesday, December 26, 2012)]
[Notices]
[Page 76024]
[FR Doc No: 2012-30987]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:

Filings Instituting Proceedings

    Docket Numbers: RP10-1069-000.
    Applicants: Kinder Morgan Interstate Gas Transmission.
    Description: TIGT 2012 Annual Reconciliation Filing to be effective
N/A.
    Filed Date: 12/18/12.
    Accession Number: 20121218-5064.
    Comments Due: 5 p.m. ET 12/31/12.

    Docket Numbers: RP13-398-000.
    Applicants: Natural Gas Pipeline Company of America.
    Description: Removal of Agreements to be effective 1/19/2013.
    Filed Date: 12/18/12.
    Accession Number: 20121218-5086.
    Comments Due: 5 p.m. ET 12/31/12.

    Docket Numbers: RP13-399-000.
    Applicants: NGO Transmission, Inc.
    Description: NGO Transmission--Negotiated Rate Filing to be
effective 1/1/2013.
    Filed Date: 12/18/12.
    Accession Number: 20121218-5092.
    Comments Due: 5 p.m. ET 12/31/12.

    Docket Numbers: RP13-400-000.
    Applicants: TC Offshore LLC.
    Description: Negotiated Rate Agreements to be effective 11/1/2012.
    Filed Date: 12/18/12.
    Accession Number: 20121218-5154.
    Comments Due: 5 p.m. ET 12/31/12.

    Docket Numbers: RP13-401-000.
    Applicants: Gulf South Pipeline Company, LP.
    Description: FSS Open Season Option to be effective 1/18/2013.
    Filed Date: 12/19/12.
    Accession Number: 20121219-5021.
    Comments Due: 5 p.m. ET 12/31/12.

    Docket Numbers: RP13-402-000.
    Applicants: Gulfstream Natural Gas System, L.L.C.
    Description: Gulfstream Natural Gas System, L.L.C. submits tariff
filing per 154.204: Negotiated Rate Agreement--contract 9120401 to be
effective 1/1/2013.
    Filed Date: 12/19/12.
    Accession Number: 20121219-5033.
    Comments Due: 5 p.m. ET 12/31/12.

    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.

Filings in Existing Proceedings

    Docket Numbers: RP12-1134-001.
    Applicants: Fayetteville Express Pipeline LLC.
    Description: FEP 2012 Hub Service--Substitute Sheet Filing to be
effective 1/1/2013.
    Filed Date: 12/18/12.
    Accession Number: 20121218-5155.
    Comments Due: 5 p.m. ET 12/31/12.
    Any person desiring to protest in any the above proceedings must
file in accordance with Rule 211 of the Commission's Regulations (18
CFR 385.211) on or before 5:00 p.m. Eastern time on the specified
comment date.
    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, and service can be found at:
http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other
information, call<PHONE_NUMBER> (toll free). For TTY, call (202) 502-
8659.

    Dated: December 19, 2012.
Nathaniel J. Davis, Sr.,
Deputy Secretary
[FR Doc. 2012-30987 Filed 12-21-12; 4:15 pm]
BILLING CODE 6717-01-P


[Federal Register: June 13, 2007 (Volume 72, Number 113)]
[Notices]
[Page 32640]
[DOCID:fr13jn07-62]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RM07-9-000]

Notice of Inquiry on Adequacy of FERC Financial Forms; Notice of
Workshop

June 6, 2007.
    The staff of the Federal Energy Regulatory Commission (Commission)
will hold an informal workshop in the above-referenced proceeding on
July 18, 2007, at the Federal Energy Regulatory Commission, 888 First
Street, NE., Washington, DC 20426 in meeting room 3M-2A&B from 9:30
a.m. until 12:30 p.m. Eastern Time.
    The purpose of this staff workshop is to address the need for
changes or revisions to the Commission's reporting requirements in the
FERC Form 6. By addressing these issues, the Commission staff is
providing an informal forum for market participants and stakeholders in
the oil industry to explore ways to improve the quality and usefulness
of information contained in this form. During the staff workshop, the
following questions will be addressed:
    How do you use the FERC Form 6?
    What information from the FERC Form 6 is most helpful to you?
    What additional information should be included in the FERC Form 6?
    How would including additional information be helpful to you?
    What changes, if any, to the FERC Form 6 do you believe are
necessary?
    How burdensome would any suggested changes be to filers of the FERC
Form 6?
    The workshop will be held in room 3M-2A&B, which accommodates about
90 people. All interested persons are invited, and there is no
registration fee to attend. Seating will be on a first-come, first-
served basis.
    This workshop will be neither webcasted nor transcribed.
    Questions about the conference should be directed to Samuel Berrios
by e-mail at<EMAIL_ADDRESS>or by phone at<PHONE_NUMBER>.

Kimberly D. Bose,
Secretary.
 [FR Doc. E7-11364 Filed 6-12-07; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 82, Number 208 (Monday, October 30, 2017)]
[Notices]
[Pages 50138-50139]
[FR Doc No: 2017-23520]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-3275]

Product Labeling for Certain Ultrasonic Surgical Aspirator
Devices; Guidance for Industry and Food and Drug Administration Staff;
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 the guidance entitled ``Product Labeling for
Certain Ultrasonic Surgical Aspirator Devices.'' FDA is providing a
specific labeling recommendation in this guidance to promote the safe
and effective use of ultrasonic surgical aspirator devices. The
labeling recommendation is being made in light of the risk of tissue
dissemination and relates to use of these devices in the removal of
uterine fibroids.

DATES: The announcement of the guidance is published in the Federal
Register on October 30, 2017.

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 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-2016-D-3275 for ``Product Labeling for Certain Ultrasonic Surgical
Aspirator Devices; Guidance for Industry and Food and Drug
Administration Staff.'' 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 Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday.
     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 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.gpo.gov/fdsys/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 Dockets Management Staff, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    An electronic copy of the guidance document is available for
download from the internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance. Submit written
requests for a single hard copy of the guidance document entitled
``Product Labeling for Certain Ultrasonic Surgical Aspirator Devices''
to the Office of the Center Director, Guidance and Policy Development,
Center for Devices and Radiological Health, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver
Spring, MD 20993-0002. Send one self-

addressed adhesive label to assist that office in processing your
request.

FOR FURTHER INFORMATION CONTACT: Trisha Eustaquio, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 1529, Silver Spring, MD 20993-0002, 301-
796-5214.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is issuing this guidance to recommend the addition of a
specific safety statement to the product labeling of certain ultrasonic
surgical aspirator devices. This guidance applies to ultrasonic
surgical aspirator devices with indications for use in laparoscopic
surgery, open surgery, or gynecologic surgery, as such surgeries can
include gynecologic procedures. Ultrasonic surgical aspirator devices
are surgical tools intended to fragment, emulsify, and aspirate hard
and soft tissue. However, the mechanism of action of ultrasonic
surgical aspirator devices creates the potential for tissue
dissemination. In light of this risk, FDA is providing a specific
labeling recommendation in this guidance regarding use of these devices
in the removal of uterine fibroids.
    FDA is aware that ultrasonic surgical aspirator devices are
sometimes used to treat advanced malignancy through cytoreduction (also
known as debulking). When used in advanced cancers, the risk of adverse
clinical effects from tissue dissemination may be small compared to the
device's potential benefits. In certain clinical circumstances,
however, the unintended dissemination of cancerous cells may have a
significant adverse effect that outweighs any demonstrated benefits.
Specifically, use of an ultrasonic surgical aspirator device during
treatment for symptomatic uterine fibroids on a woman with an occult
uterine sarcoma could result in dissemination of this cancer.
Therefore, FDA recommends that manufacturers of ultrasonic surgical
aspirator devices with indications for use in laparoscopic surgery,
open surgery, or gynecologic surgery prominently include a specific
contraindication in their product labeling that the device is not
indicated for and should not be used for the fragmentation,
emulsification, and aspiration of uterine fibroids.
    In the Federal Register on November 10, 2016 (81 FR 79028), FDA
announced the availability of the draft guidance and interested parties
were invited to comment by January 9, 2017. FDA has considered all of
the public comments received prior to finalizing this guidance.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on ``Product Labeling for Certain Ultrasonic
Surgical Aspirator Devices.'' 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. This guidance is not subject to Executive
Order 12866.

III. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so by
downloading an electronic copy from the internet. A search capability
for all Center for Devices and Radiological Health guidance documents
is available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance
documents are also available at https://www.regulations.gov. Persons
unable to download an electronic copy of ``Product Labeling for Certain
Ultrasonic Surgical Aspirator Devices; Guidance for Industry and Food
and Drug Administration Staff'' may send an email request to [email protected] to receive an electronic copy of the document.
Please use the document number 1500072 to identify the guidance you are
requesting.

IV. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of
information found in 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 21 CFR part 807, subpart E have been
approved under OMB control number 0910-0120 and the collections of
information in 21 CFR part 801 have been approved under OMB control
number 0910-0485.

    Dated: October 25, 2017.
Lauren Silvis,
Chief of Staff.
[FR Doc. 2017-23520 Filed 10-27-17; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 79, Number 54 (Thursday, March 20, 2014)]
[Proposed Rules]
[Pages 15555-15556]
[FR Doc No: 2014-06007]

=======================================================================
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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2014-0132; Directorate Identifier 2012-NM-007-AD]
RIN 2120-AA64

Airworthiness Directives; Airbus Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Proposed rule; correction.

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SUMMARY: The FAA is correcting a Notice of Proposed Rulemaking (NPRM)
that published in the Federal Register. The NPRM applies to certain
Airbus Model A330-200 and -300 series airplanes, and Model A340-200 and
-300 series airplanes. The docket number identified throughout the NPRM
is incorrect. This document corrects that error. In all other respects,
the original document remains the same.

DATES: The last date for submitting comments to the NPRM (79 FR 7098,
February 6, 2014) remains March 24, 2014.

ADDRESSES: You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2014-
0132; or in person at the Docket Management Facility between 9 a.m. and
5 p.m., Monday through Friday, except Federal holidays. The AD docket
contains this AD action, the regulatory evaluation, any comments
received, and other information. The address for the Docket Office
(phone:<PHONE_NUMBER>) is Docket Management Facility, U.S. Department of
Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590.

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

SUPPLEMENTARY INFORMATION: On January 29, 2014, the FAA issued a Notice
of Proposed Rulemaking (NPRM) (79 FR 7098, February 6, 2014) for
certain Airbus Model A330-200 and -300 series airplanes, and Model
A340-200 and -300 series airplanes. The NPRM, Directorate Identifier
2012-NM-007-AD, currently proposes to require repetitive draining of
any fluid from the retraction actuator piston rod internal volume and
sealing of the vent hole; repetitive ultrasonic inspections of the
upper end of the piston rods, and corrective actions if necessary; a
one-time ultrasonic inspection (longitudinal and circumferential) of
the full-length of the piston rod, and corrective actions if necessary;
and a terminating modification of the left-hand and right-hand main
landing gear (MLG) retraction actuators.
    As published, the NPRM (79 FR 7098, February 6, 2014) specifies an
incorrect docket number throughout the preamble and regulatory text. We
have been informed that a duplicate docket number was inadvertently
assigned to us for the NPRM. The correct docket number is FAA-2014-
0132.
    Commenters who submitted comments to the original (incorrect)
docket number should check Docket No. FAA-2014-0012 and Docket No. FAA-
2014-0132 on http://www.regulations.gov to determine whether their
comments have been received and filed in the appropriate docket. If
not, or if it is not possible to determine whether comments have been
posted to the correct docket, the comments should be resubmitted using
the correct docket number.
    No other part of the preamble or regulatory information has been
changed; therefore, only the changed portion of the NPRM (79 FR 7098,
February 6, 2014) is being published in the Federal Register.
    The last date for submitting comments to the NPRM (79 FR 7098,
February 6, 2014) remains March 24, 2014.

Correction of Non-Regulatory Text

    In the Federal Register of February 6, 2014, Directorate Identifier
2012-NM-007-AD is corrected as follows:
    On page 7098, in the first column, on line four of the headings
section, correct ``Docket No. FAA-2014-0012'' to read ``Docket No. FAA-
2014-0132.''
    On page 7098, in the second column, on line four under ``Examining
the AD Docket,'' correct ``Docket No. FAA-2014-0012'' to read ``Docket
No. FAA-2014-0132.''
    On page 7098, in the third column, on line five under
``SUPPLEMENTARY INFORMATION: Comments Invited,'' correct ``Docket No.
FAA-2014-0012'' to read ``Docket No. FAA-2014-0132.''
    On page 7099, in the second column, on line fifteen, correct
``Docket No. FAA-2014-0012'' to read ``Docket No. FAA-2014-0132.''

Correction of Regulatory Text

Sec.  39.13 [Corrected]

0
1. On page 7100, in the second column, amendatory instruction 2. and
the heading of Docket No. FAA-2014-0132 are corrected to read as
follows:
0
2. The FAA amends Sec.  39.13 by removing airworthiness directive (AD)
2004-16-01, Amendment 39-13757 (69 FR 46979, August 4, 2004), and
adding the following new AD:

Airbus: Docket No. FAA-2014-0132; Directorate Identifier 2012-NM-
007-AD.
* * * * *
0
2. On page 7103, in the second column, paragraph (y)(1) of NPRM Docket
No. FAA-2014-0132 is corrected to read as follows:
* * * * *
    (1) Refer to Mandatory Continuing Airworthiness Information (MCAI)
European Aviation Safety Agency Airworthiness Directive 2011-0178R1,
dated March 6, 2012 (corrected March 7, 2012); and 2011-0179R1, dated
March 6, 2012; for related information. These MCAIs may be found in the
AD docket on the Internet at http://www.regulations.gov by searching
for and locating Docket No. FAA-2014-0132.
* * * * *

    Issued in Renton, Washington, on March 13, 2014.
Jeffrey E. Duven,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2014-06007 Filed 3-19-14; 8:45 am]
BILLING CODE 4910-13-P


SMART Meeting/ Aliphatic Solvents Case Page 1 4/ 19/ 06 SMART Meeting: April 19, 2006 Aliphatic Solvents Case Mineral Oils / Aliphatic Petroleum Hydrocarbons Attendees:

Name Division/ Company Akiva Abramovitch EPA/ RD Brian Anderson EPA/ EFED Wilfred Burr USDA/ OPMP Robert Butz ChemReg Steve Carey EPA/ EFED/ ERBB Mark Corbin EPA/ EFED Becky Daiss EPA/ HED Jim Damico SciReg, Inc.

David Dawe SciReg, Inc.

Michael Fefer Petro Canada Anne Goldsmith Calumet Lubricants Co.

Bentley Gregg EPA/ SRRD Arthur Grube EPA/ BEAD/ EAB Jennifer Hall Sunoco, Inc.

John Hebert EPA/ RD Kelly McAloon Versar, Inc.

Richard Michell EPA/ BEAD/ BAB Nathan Mottl EPA/ SRRD Roy Olson Drexel Chemical Co.

John Pates EPA/ SRRD Mark Perry EPA/ SRRD Fred Smith SciReg, Inc.

Stephanie Syslo EPA/ OPP/ EFED Bob Vincent BVA Kedra Wherry Drexel Chemical Co.

Nancy Wright Sunoco, Inc. SMART Meeting/ Aliphatic Solvents Case Page 2 4/ 19/ 06 A. Introduction and Purpose of the SMART meeting Ben Gregg of EPA/ SRRD welcomed everyone to the meeting and began with introductions of those present, and then provided some background information:

A meeting was held with the Horticultural Spray Oil Task Force back on October 13, 1999 on the aliphatic solvents and SRRD has received the PowerPoint presentations from that meeting, and they have been very helpful in providing information on the production methods for the spray oils, as well as some data on the mammalian toxicity and the environmental fate and effects ( although it is somewhat historical information).

There is an August 3, 2006 deadline for the aliphatic solvents RED, as mandated by FQPA.

The information found/ provided indicates that there are two food tolerances still active, for post harvest corn and sorghum, but SRRD asked those in attendance if anyone has any information on whether these usage patterns are still in use ( a preliminary survey of the 165 labels does not reveal any labels which still list these uses).

EPA still has some information/ data needs, and the purpose of this meeting is to share what EPA does have and an update on the status within the various divisions in their assessments, and what information is still needed.

B. Current Status of the RED Data and Assessments SRRD:

Ben Gregg of SRRD gave a brief synopsis of the role of SRRD in the RED process.

RED stands for Reregistration Eligibility Decision.

The process has been in use for a long time, since the early 1990s for REDs, and back into the 1980s for developing Registration Standards for the various active ingredients.

Congress had mandated the reregistration of pesticide chemicals.

For the low risk REDs, a more expedited single phase process has been developed as opposed to that used for most products, either a 4 phase or 6 phase process for other REDs.

Since the chemicals in these low risk REDs are expected to have low toxicity, SRRD receives little data from HED, but does receive help from EFED and BEAD and also has interactions with the Registration Division ( RD).

All these divisions pull together their own sections of the RED document and SRRD combines these materials into the one final document.

SRRD also tracks data call in materials and reviews these documents. After REDs are issued, the Agency prefers to receive product specific data, especially for product chemistry data, but for acute toxicity testing, it will allow for some batching if the chemicals are similar ( to reduce the number of animals which may be needed for acute toxicity testing). SMART Meeting/ Aliphatic Solvents Case Page 3 4/ 19/ 06 ** At this point in the meeting, Nancy Wright of Sunoco, Inc, and Jim Damico of SciReg, Inc., ( both representatives of the Horticultural Spray Oil Task Force [ HSOTF]) asked to read aloud an anti trust compliance statement from the Task Force.**

BEAD Arthur Grube of BEAD provided some background on the information available on usage of spray oils on various crops, typical application rates versus maximum application rates listed on labels, and the sources of information on amounts and crops.

Grube indicated that the data sources suggest there is information on fewer products than the full number of those registered; it was difficult at first to identify the full data set of names for the chemicals as collected within each of the various data bases; it was assumed that this may be due to the diversity of data reporting and the fact that most products are reported as petroleum oils or petroleum distillates; they are lumped together by name in most cases.

Based on the sources of data, BEAD has prepared a SLUA ( Screening Level Usage Analysis), which provides a broad outline summary of usage ( including pounds of active ingredient, percent of crop treated, and maximum percent of crop treated).

The pounds of active ingredient and percent of crop treated are average numbers.

The percent of crop treated provided in SLUA comes from several data sources, including 2 major sources and 2 additional sources, which are used if the required information is not available from the major sources: o NASS ( National Agricultural Statistics Service) of USDA ( Major source)

Been collected since 1990

Collect data by state, yearly for several major field crops and alternate years for fruit and vegetables

Information includes: percent crop treated, pounds of active ingredient used, application rates, number of applications

Publicly available information o Doane Marketing Research ( Major source)

Proprietary information

Provided in the form of a database

Information includes: pounds of active ingredients, acres treated, application rates, pest targets

Doane collects data yearly for most crops and for most states o California Department of Pesticide Regulation ( CalDPR) ( Additional source)

Data can be very detailed, down to the field level

CalDPR requires all farmers to report pesticide applications

Information includes: summary of pounds of active ingredients by pesticide and crop, as well as individual application information by date and location. SMART Meeting/ Aliphatic Solvents Case Page 4 4/ 19/ 06

Used mostly when most of crop is grown in California and neither NASS nor Doane provide adequate information o National Center for Food and Agricultural Policy ( NCFAP; specifically Leonard Gianessi) ( Additional source)

Data tends to be older; and it is not always clear when it was collected

Information includes: percent crop treated, pounds of active ingredient used, and application rates

Database updated every 5 years

NASS and Doane data based on surveys; therefore, the data do show some fluctuations, and there is some degree of uncertainty associated with those datasets.

Handouts were provided showing SLUA data for petroleum oils, as well as data collected from NASS.

Based on the numbers provided on SLUA for petroleum oils, citrus appears to have the highest usage, but SLUA covers many other crops as well.

Some crops are listed that are not registered, and it is believed that this may indicate some misuse of the products OR it could indicate cancelled products/ uses.

A. Grube also provided usage data obtained from NASS ( National Agricultural Statistics Service).

He indicated that all use rates were lower than the maximum application rates listed on the various product labels, and that there is a need for information on what rates are actually typically used by applicators.

J. Damico indicated that the Task Force was in the process of gathering data and should be able to provide it within a week or two. He indicated that it was fairly specific ( by state and crop), and would need to be treated as confidential, because the various companies on HSOTF view their own data as proprietary.

EFED Mark Corbin provided some information on the status of EFED with respect to the aliphatic solvents.

On the exposure side of the assessment, one issue is a lack of data; specifically, the lack of information on the physical and chemical properties of the chemicals, which reflect their environmental fate properties.

EFED is using a tiered approach and screening level models in a generic way in order to do the assessment with the limited data on hand.

Their assessment is focused mostly on the aquatic side, in terms of effects of offsite drift and of run off.

The environmental risk assessments related to mosquito applications are being done separately from the agricultural uses of spray oils.

The agricultural spray oil assessment is being conducted using the HydroCarbon Block Method, which is based on published information. This Block Method is used to get an idea of the range of constituents of the petroleum oil, and to SMART Meeting/ Aliphatic Solvents Case Page 5 4/ 19/ 06 provide estimates of the environmental fate properties of the spray oils based on the individual components.

On the terrestrial side of the assessment, the approach is an even more simplified tiered approach; there are some laboratory toxicity data for birds and mammals, and a screening level approach will be taken; the resulting assessment suggests that the main concern is for bird eggs.

Regarding the aquatic toxicity data, it appears that for fish, the spray oils are not very toxic; however, for aquatic invertebrates, the acute data indicate a high level of toxicity to daphnia; the oyster is fairly sensitive as well, based on one oyster shell deposition study.

J. Damico indicated that the Task Force has submitted two studies to EPA relative to Generic Data Call Ins for environmental fate data: one document on adsorption/ desorption ( MRID 459453 01) and another on spray drift ( MRID 460428 01).

HED Ben Gregg provided some background on the acute, sub chronic and chronic toxicity information available, as well as the status of the worker exposure and risk assessment.

For the acute toxicity studies, toxicity does not appear to be high; all the LD50 values are quite high.

For the sub chronic and chronic toxicity, repeated dose studies, there is some information available ( various 28 day dermal studies and a variety of repeat dose inhalation studies).

An IARC document from 1982 indicates that one of the chemicals included in the aliphatic solvents Case ( i. e., Mineral Oil) is a carcinogen; however, IARC revised this decision in 1987 to reflect that only the untreated form of Mineral Oil is carcinogenic. When Mineral Oils are moderately to highly treated, there is no carcinogenic risk.

There have been waiver requests submitted for the repeat dose inhalation studies; however, there are several studies that have been submitted and reviewed by the Agency ( e. g., 5 day, 9 day and 28 day inhalation studies, with DERs having been written); these studies were performed as whole body exposures; most effects seen were primarily physical effects.

In addition, a 90 day inhalation study was submitted in 2000, which was performed as a nose only exposure, examining solely the technical product used in the field. The study was submitted for a mosquito larvicide product, but for extrapolating these data to agricultural products that may be mixed with water, there may be a potential for the water mixture to alter the inhalation toxicity. A DER is currently being written for this 90 day inhalation study, and an inhalation toxicologist from HED will assist SRRD in interpreting these data.

A worker assessment will be performed for inhalation only, examining a range of scenarios and application equipment ( including homeowner application). SMART Meeting/ Aliphatic Solvents Case Page 6 4/ 19/ 06

It is possible that some scenarios might result in worker risk concerns, and thus there may be a need for additional PPE ( for example, it might be possible that applicators operating airblast equipment may be required to wear a respirator).

RD Akiva Abramovitch provided some information from the Registration Division of EPA.

He noted that normally EPA deals with chemicals for which there is one specific name for the active ingredient.

In the case of these petroleum spray oils, however, there is much more information provided on the labels as far as the chemical name and some properties of the active ingredient, because the labels are dealing with a mixture.

Specifically, there is an issue with the fact that there are multiple names for similar chemicals, and there are different percents of unsulfonated residues and boiling ranges reported on the various labels.

There is difficulty in finding correlations between what might be similar products, and he suggested trying to come to some consistency in the naming of these active ingredients.

There is also an issue with the PC codes; there are 2 codes with no obvious explanation as to why there are two; however, it was suggested that the PC code issue was related to a historical issue within RD among the PMs; there may have been confusion as to how to classify these chemicals initially.

J. Damico of the Task Force indicated that they agree that there is confusion on the naming, and noted that there have been talks with the Agency on condensing the names down to one name, " mineral oil", with specifications associated with that name: o Specifications relate to 21 CFR 178.3620( c):

Refined from Virgin Crude Oil

Color per ASTM D1500 = 5.5 maximum

Distillation per D1160 @ 10 mmHg   Initial boiling point converted to atmospheric pressure = 450oF maximum

Ultraviolet absorbance limits per 21 CFR 178.3620( c) iii. o 1997 Series 62 Proposal   Modified/ added requirements:

Distillation per D1160 @ 10 mmHg   Initial boiling point converted to atmospheric pressure = 550oF minimum

Unsulfonated residue per ASTM D483 = 92% minimum

Michael Fefer of Petro Canada presented a somewhat different recommendation concerning the nomenclature.

A representative of EFED ( Steph Syslo) indicated that it would be helpful to identify and classify chain lengths since the toxicities could differ based on the chain length.

Anne Goldsmith, of Calumet Lubricants Co, indicated that the most objective way ( from a manufacturer's point of view) to describe oils is to use their boiling point; chain length could be isolated, but that is not the general practice and is fairly SMART Meeting/ Aliphatic Solvents Case Page 7 4/ 19/ 06 difficult; the mineral oil specifications were developed to limit the number of chains and to require a level of purity down to very low levels of aromatic and naphtha components to avoid phytotoxicity ( but that some small percentage of these components were needed to provide pourability   if the percents are too low, the materials are paraffin waxes and will not pour).

It was noted by Ben Gregg that this discussion on nomenclature would be taken up again with SRRD's Division Director and maybe RD's Division Director, and possibly the OPP Office Director as well, and that the issue would not be resolved at this meeting.

Inerts Ben Gregg stated that there are exemptions from the requirement for a tolerance listed in 40 CFR Part 180.910 for food [ and 180.930 for animal uses] which specifically list Mineral Oil, as well as petroleum hydrocarbons, light odorless, and petroleum hydrocarbons, synthetic isoparaffinic with various sections of 21 CFR cited for various of these ingredient oils. There is also an exemption from the requirement for a tolerance listed in 40 CFR 180.905 for " petroleum oils." ( In addition, there are the two food use tolerances listed for " Mineral Oil" as an active ingredient; for post harvest corn and for post harvest sorghum, at 40 CFR 180.149.)

C. Areas where OPP still has requests for additional data for refining the RED Ben Gregg presented several questions on which OPP would appreciate any additional information. These questions are outlined below, along with input received during the meeting. Additional input is expected from the HSOTF, and various registrants.

Question# 1: Actual Use and Usage Data: Do you agree with the Agency's use estimates outlined in the Screening Level Usage Analysis ( SLUA)? If not, please explain the specific disagreement and provide rationale and data sources. In the past three years, how many pounds of active ingredient were used nationally for each use site? Please provide regional information as well. What are the typical application rates for each use site? Please provide regional information as well. Do you have any additional information? If your estimates are from a single source, how do they compare with publicly available sources, such as from USDA and California DPR?

Responses: David Dawe ( SciReg): For the most part, yes. Grapes were apparently not properly reported in the 1997 Gianessi document. The label rates will vary and are specific to each crop because the amount needed to cover each crop is well defined.

Arthur Grube ( BEAD): On the NASS handout, the maximum application rate identified on labels ( 477 lb ai/ A) does not appear in the averages reported, but this does not mean this rate is not being used. SMART Meeting/ Aliphatic Solvents Case Page 8 4/ 19/ 06 Mark Corbin ( EFED): Knowing average application rates is good in order to characterize the actual maximum rates; however, there is a need to know the reported maximum rates actually being used and where they are actually being applied, geographically ( especially when dealing with endangered species).

Question# 2: By use site, how many total acres are treated per day?

Responses: David Dawe ( SciReg): For orchards, the application method is typically airblast and is not done as a spot treatment. The high range applications can reach 800 gal/ A [ as the volume of spray mix], but applicators are trying to cut back on the volume being used. Typical ranges are from 50 200 gal/ A or from 100 800 gal/ A.

Question# 3: For each major use site, how many different applications might be made per season for each method of application?

Reponses: David Dawe ( SciReg): More applications are made on some crops than others. Most times this is weather related. Typically, there is only one application per year.

Question# 4: What is the total time during the year that any one commercial applicator may be applying these products ( more than one month at a time anywhere in the country)?

Responses: David Dawe ( SciReg): A month is probably a reasonable time. The application is performed late in the season and commonly used insect life cycle models are used to pinpoint the best application time.

Question# 5: What are the typical application rates? What information do you have on how often these Mineral Oil / Aliphatic Petroleum Hydrocarbon products are used in combination with other pesticides?

Responses: David Dawe ( SciReg): Applicators routinely use tank mixes. It is uncommon to just apply the water mixed mineral oil alone, and typically other active ingredients would also be applied.

Registrants will provide a sentence or two to EPA on this question.

Question# 6: What is the frequency and timing of application ( typical and maximum)? How often is the pesticide applied? What is the typical and minimum interval between applications? Describe seasonal variations in use. Provide information on typical and maximum areas of application.

Responses: Registrants may provide details at a later date to EPA. SMART Meeting/ Aliphatic Solvents Case Page 9 4/ 19/ 06 Question# 7: Do you know of any emerging equipment or cultural practices that could reduce exposure to your product in food, to workers, or in the environment?

Responses: Registrants may provide details at a later date to EPA.

Question# 8: What other pesticides ( insecticides/ miticides) are used instead of these products, from a cost/ benefit point of view, what are the competing products? What is unique about products containing this active ingredient? What alternatives are available? Are there any constraints to the use of alternatives such as cost or efficacy? Is there any geographic area where there are no alternatives?

Responses: Registrants may provide details at a later date to EPA.

Question# 9: PPE: Currently there seem to be no requirements for respiratory protection, even for applicators making applications with air blast equipment to orchards. Does anyone think that it would not be prudent to add language to labels to require the use of respirators ( maybe only the dust mist type) for those applicators operating air blast equipment?

Responses: Registrants indicated there is no issue as long as the requirements are equal and reasonable and the equipment is proper.

Question# 10: Homeowner Uses: Does anyone have any information indicating that home owner / residential site applications ( fruit trees, ornamentals) might pose concerns, during application or post application?

Responses: Registrants indicated most applications are performed by commercial applicators to home/ residential areas. However, there are some ready to use ( RTU)/ diluted homeowner products.

Question# 11: Spray Zone Application Restrictions: Because of the potential for certain types of ecological risk concerns ( toxic effects to aquatic water column invertebrate organisms), the Agency is considering requiring language be included on the labels for " buffer zones" for those application sites adjacent to surface waters. Is there any information on usage sites where these " spray zone application restrictions" adjacent to water bodies would be impossible or impractical? What would be a practical buffer zone, acceptable to growers, for applications to use sites, for the distance to an adjacent surface water body?

Responses: Mark Corbin ( EFED): EFED is examining the effect of buffers on exposures, which provides information on what chemicals and how much of the chemical reaches water via spray drift, not via runoff. SMART Meeting/ Aliphatic Solvents Case Page 10 4/ 19/ 06 Jim Damico ( SciReg): Noted that spray drift data was submitted to the Agency and has been requested to be reviewed.

Brian Anderson ( EFED): The daphnia study was initially classified as invalid because the solubility had not been characterized and they could not be sure of what was actually in the water ( i. e., what the daphnia were exposed to). The study is being revisited in terms of looking at it in correlation to a system being loaded with oil.

Question # 12: Are there any ecological incidents ( nontarget plant damage and avian, fish, reptilian, amphibian and mammalian mortalities) that have been reported while the current use practices have been in place?

Responses: EFED has a data base where environmental incident reports are compiled ( reporting is required under Section 6( a) 2). SRRD will check with HED for incident reports for any human exposures. Registrants are requested to provide any additional data which they may have.

Question # 13: Nomenclature: There are many names for the actual active ingredients which are listed on the various labels. Should the Agency attempt to require a more limited name or set of names? What would that name, or those few names, be?

Responses: This topic was already discussed during the meeting.

Question # 14: Does anyone have any suggestions for a different grouping of these active ingredients, than that currently being regulated and registered by the Agency?

Responses: This topic was already discussed during the meeting.

Question # 15: Tolerance Issues: Is there still any use of Mineral Oil for treatment of " post harvest corn" and " post harvest sorghum"? The only existing tolerances for this active ingredient are for these grains, " to combat storage insect infestation" ( 40 CFR 180.149). These tolerances apparently date back to over 50 years ago. Does any registrant have these uses on any of their labels, or know of any other registrants having such labels, which would make it important to retain this tolerance on the active ingredient?

The other uses for these active ingredients are apparently covered under the section involving the " exemption from the requirement for a tolerance" ( 40 CFR 180.905, .910, and [ maybe] .930).

Responses: Registrants may provide details at a later date to EPA.

Mosquito Larvicide Uses: SMART Meeting/ Aliphatic Solvents Case Page 11 4/ 19/ 06 There are some ( apparently only three) labels for end use products which permit mosquito larvicide uses. These will be the subject of a separate sub group meeting, but does anyone want to bring up any related issues during this meeting?

Responses: EPA is working with three Registrants on their mosquito larvicide labels ( Bonide, BVA, and Clark Mosquito). There are other products listed in OPPIN Query which seem to contain these oils, but further review of CSFs and/ or labels suggest that the oils are actually inert ingredients.

Ben Gregg ( SRRD): Noted that for the larvicides, the EPA works with Susan Jennings of SRRD and with the US Centers for Disease Control and Prevention ( CDC) and uses a slightly different process of review because of the unique issues associated with these mosquito control products as a result of their unique public health benefits.


[Federal Register Volume 88, Number 37 (Friday, February 24, 2023)]
[Notices]
[Page 11916]
[FR Doc No: 2023-03844]

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ENVIRONMENTAL PROTECTION AGENCY

[FRL OP-OFA-058]

Environmental Impact Statements; Notice of Availability

    Responsible Agency: Office of Federal Activities, General
Information<PHONE_NUMBER> or https://www.epa.gov/nepa.

Weekly receipt of Environmental Impact Statements (EIS)
Filed February 13, 2023 10 a.m. EST Through February 17, 2023 10 a.m.
EST
Pursuant to 40 CFR 1506.9.

    Notice: Section 309(a) of the Clean Air Act requires that EPA make
public its comments on EISs issued by other Federal agencies. EPA's
comment letters on EISs are available at: https://cdxapps.epa.gov/cdx-enepa-II/public/action/eis/search.

EIS No. 20230032, Final, USFS, WY, Invasive and Other Select Plant
Management on the Bighorn NF, Review Period Ends: 03/27/2023, Contact:
Thad Berrett<PHONE_NUMBER>.
EIS No. 20230033, Final, FHWA, LA, Lafayette Regional Xpressway Tier 1,
Contact: Larry Breland<PHONE_NUMBER>.

    Pursuant to 23 U.S.C. 139(n)(2), FHWA has issued a single FEIS and
ROD. Therefore, the 30-day wait/review period under NEPA does not apply
to this action.

EIS No. 20230034, Final, FERC, LA, Venice Extension Project, Review
Period Ends: 03/27/2023, Contact: Office of External Affairs 866-208-
3372.

    Dated: February 17, 2023.
Cindy S. Barger,
Director, NEPA Compliance Division, Office of Federal Activities.
[FR Doc. 2023-03844 Filed 2-23-23; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 78, Number 54 (Wednesday, March 20, 2013)]
[Notices]
[Pages 17204-17205]
[FR Doc No: 2013-06314]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2012-0938; FRL-9374-7]

Pesticide Reregistration Performance Measures and Goals; Annual
Progress Report; Notice of Availability

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of availability.

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SUMMARY: This notice announces the availability of EPA's progress
report in meeting its performance measures and goals for pesticide
reregistration during fiscal year 2012.

FOR FURTHER INFORMATION CONTACT: Carol P. Stangel, Pesticide Re-
evaluation Division (7508P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460-0001; telephone number:<PHONE_NUMBER>; email
address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Why is EPA announcing the availability of this report?

    The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)
requires EPA to publish information about EPA's annual achievements in
meeting its performance measures and goals for pesticide
reregistration. The report for fiscal year 2012 discusses the
integration of tolerance reassessment with the reregistration process,
and describes the status of various regulatory activities associated
with reregistration and tolerance reassessment. The 2012 report also
gives total numbers of products reregistered and products registered
under the ``fast-track'' provisions of FIFRA.

II. How can I get a copy of the 2012 report?

    1. Docket. The 2012 report is available at http://www.regulations.gov, under

docket ID number EPA-HQ-OPP-2012-0938.
    2. EPA Web site. The 2012 report is also available on EPA's Web
site at http://www.epa.gov/pesticides/reregistration/reports.htm.

III. Can I comment on this report?

    Although not subject to a formal comment period, EPA welcomes input
from stakeholders and the general public. Written comments, identified
by the docket identification number EPA-HQ-OPP-2012-0938, would be most
helpful if received by EPA on or before May 20, 2013.
    Submit your comments, identified by docket identification (ID)
number EPA-HQ-OPP-2012-0938, 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.

List of Subjects

    Environmental protection, Pesticides and pests.

    Dated: March 11, 2013.
James Jones,
Acting Assistant Administrator, Office of Chemical Safety and Pollution
Prevention.
[FR Doc. 2013-06314 Filed 3-19-13; 8:45 am]
BILLING CODE 6560-50-P