[Federal Register Volume 79, Number 182 (Friday, September 19, 2014)]
[Proposed Rules]
[Pages 56316-56319]
[FR Doc No: 2014-21969]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 100

[Docket Number USCG-2014-0783]
RIN 1625-AA08

Special Local Regulations for Marine Events, Spa Creek;
Annapolis, MD

AGENCY: Coast Guard, DHS.

ACTION: Notice of proposed rulemaking.

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SUMMARY: The Coast Guard proposes to temporarily change the enforcement
periods of special local regulations for a recurring marine event in
the Fifth Coast Guard District. These regulations apply to the MRE Tug
of War, a recurring marine event, and would be effective on November 8,
2014. Special local regulations are necessary to provide for the safety
of life on navigable waters during the event. This action is intended
to restrict vessel traffic in a portion of Spa Creek at Annapolis, MD
during the event.

DATES: Comments and related material must be received by the Coast
Guard on or before October 20, 2014.

ADDRESSES: You may submit comments identified by docket number using
any one of the following methods:
    (1) Federal eRulemaking Portal: http://www.regulations.gov.
    (2) Fax:<PHONE_NUMBER>.
    (3) Mail or Delivery: Docket Management Facility (M-30), U.S.
Department of Transportation, West Building Ground Floor, Room W12-140,
1200 New Jersey Avenue SE., Washington, DC 20590-0001. Deliveries
accepted between 9 a.m. and 5 p.m., Monday through Friday, except
federal holidays. The telephone number is<PHONE_NUMBER>.

See the ``Public Participation and Request for Comments'' portion of
the SUPPLEMENTARY INFORMATION section below for further instructions on
submitting comments. To avoid duplication, please use only one of these
three methods.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email Mr. Ronald Houck, U.S. Coast Guard Sector Baltimore, MD;
telephone<PHONE_NUMBER>, email<EMAIL_ADDRESS>If you have
questions on viewing or submitting material to the docket, call Cheryl
Collins, Program Manager, Docket Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Table of Acronyms

DHS Department of Homeland Security
FR Federal Register
NPRM Notice of Proposed Rulemaking

A. Public Participation and Request for Comments

    We encourage you to participate in this rulemaking by submitting
comments and related materials. All comments received will be posted
without change to http://www.regulations.gov and will include any
personal information you have provided.

1. Submitting Comments

    If you submit a comment, please include the docket number for this
rulemaking, indicate the specific section of this document to which
each comment applies, and provide a reason for each suggestion or
recommendation. You may submit your comments and material online at
http://www.regulations.gov, or by fax, mail, or hand delivery, but
please use only one of these means. If you submit a comment online, it
will be considered received by the Coast Guard when you successfully
transmit the comment. If you fax, hand deliver, or mail your comment,
it will be considered as

having been received by the Coast Guard when it is received at the
Docket Management Facility. We recommend that you include your name and
a mailing address, an email address, or a telephone number in the body
of your document so that we can contact you if we have questions
regarding your submission.
    To submit your comment online, go to http://www.regulations.gov,
type the docket number [USCG-2014-0783] in the ``SEARCH'' box and click
``SEARCH.'' Click on ``Submit a Comment'' on the line associated with
this rulemaking.
    If you submit your comments by mail or hand delivery, submit them
in an unbound format, no larger than 8\1/2\ by 11 inches, suitable for
copying and electronic filing. If you submit comments by mail and would
like to know that they reached the Facility, please enclose a stamped,
self-addressed postcard or envelope. We will consider all comments and
material received during the comment period and may change the rule
based on your comments.

2. Viewing Comments and Documents

    To view comments, as well as documents mentioned in this preamble
as being available in the docket, go to http://www.regulations.gov,
type the docket number (USCG-2014-0783) in the ``SEARCH'' box and click
``SEARCH.'' Click on Open Docket Folder on the line associated with
this rulemaking. You may also visit the Docket Management Facility in
Room W12-140 on the ground floor of the Department of Transportation
West Building, 1200 New Jersey Avenue SE., Washington, DC 20590,
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays.

3. Privacy Act

    Anyone can search the electronic form of comments received into any
of our dockets by the name of the individual submitting the comment (or
signing the comment, if submitted on behalf of an association,
business, labor union, etc.). You may review a Privacy Act notice
regarding our public dockets in the January 17, 2008, issue of the
Federal Register (73 FR 3316).

4. Public Meeting

    We do not now plan to hold a public meeting. But you may submit a
request for one, using one of the methods specified under ADDRESSES.
Please explain why you believe a public meeting would be beneficial. If
we determine that one would aid this rulemaking, we will hold one at a
time and place announced by a later notice in the Federal Register.

B. Regulatory History and Information

    This marine event is regulated at 33 CFR Sec.  100.501. The dates
of the event as published are October--last Saturday; or November--1st
Saturday.

C. Basis and Purpose

    The legal basis and authorities for this rulemaking establishing a
special local regulation are found in 33 U.S.C. 1233, which authorize
the Coast Guard to establish and define special local regulations. The
Captain of the Port Baltimore is establishing a special local
regulation for the waters of the Spa Creek, at Annapolis, MD to protect
event participants, spectators and transiting vessels. Entry into this
area is prohibited unless specifically authorized by the Captain of the
Port Baltimore or designated representative.

D. Discussion of Proposed Rule

    Marine events are frequently held on the navigable waters within
the boundary of the Fifth Coast Guard District. The activities that
typically comprise marine events include but are not limited to sailing
regattas, power boat races, swim races and holiday parades. The
regulation listing annual marine events within the Fifth Coast Guard
District and their regulated dates is 33 CFR 100.501. The Table to
Sec.  100.501 identifies marine events by Captain of the Port zone. For
a description of the geographical area of each Coast Guard Sector--
Captain of the Port Zone, please see 33 CFR 3.25.
    Event planners notified the Coast Guard of date changes for the
``MRE Tug of War'' marine event that is listed at 33 CFR 100.501, Table
to Sec.  100.501. This regulation temporarily changes the enforcement
period for this marine event for 2014 only. The enforcement date for
2014 is November 8, 2014.
    The annual ``MRE Tug of War,'' marine event is sponsored by the
Maritime Republic of Eastport; and takes place on the waters of Spa
Creek at Annapolis, MD. The regulation at 33 CFR 100.501 is effective
annually for the MRE Tug of War marine event. The event consists of
extending a 1,500-foot rope across the navigable waters of Spa Creek at
Annapolis, MD. Participants on shore are assisted by sponsor-provided
support craft. Therefore, to ensure the safety of participants and
support vessels, 33 CFR 100.501 is enforced for the duration of the
event. During the enforcement period vessels may not enter the
regulated area unless they receive permission from the Coast Guard
Patrol Commander. Vessel traffic may contact the Coast Guard Patrol
Commander to request permission to pass through the regulated area. If
permission is granted, vessels must pass directly through the regulated
area at safe speed and without loitering.

E. Regulatory Analyses

    We developed this proposed rule after considering numerous statutes
and executive orders related to rulemaking. Below we summarize our
analyses based on a number of these statutes or executive orders.

1. Regulatory Planning and Review

    This proposed rule is not a significant regulatory action under
section 3(f) of Executive Order 12866, Regulatory Planning and Review,
as supplemented by Executive Order 13563, Improving Regulation and
Regulatory Review, and does not require an assessment of potential
costs and benefits under section 6(a)(3) of Executive Order 12866 or
under section 1 of Executive Order 13563. The Office of Management and
Budget has not reviewed it under those Orders.
    The economic impact of this rule is not significant for the
following reasons: (i) The regulated area will be in effect for a
limited duration; (ii) the regulated area has been narrowly tailored to
impose the least impact on general navigation, yet provide the level of
safety deemed necessary; and (iii) advance notifications will be made
to the maritime community via marine information broadcasts and local
notices to mariners, so mariners can adjust their plans accordingly.
Additionally, this rulemaking does not change the permanent regulated
areas that have been published in 33 CFR 100.501, Table to Sec.
100.501. In some cases, vessel traffic may be able to transit the
regulated area when the Coast Guard Patrol Commander grants permission
to do so. For the above reasons, the Coast Guard does not anticipate
any significant economic impact.

2. Impact on Small Entities

    Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have
considered the impact of this proposed rule on small entities. The
Coast Guard certifies under 5 U.S.C. 605(b) that this proposed rule
will not have a significant economic impact on a substantial number of
small entities.
    This rule may affect the following entities, some of which may be
small entities: The owners or operators of vessels intending to enter,
transit through, anchor in, or remain within the area where the marine
event is being held. This regulation will not have a

significant impact on a substantial number of small entities because it
will be enforced only during a marine event that has been permitted by
the Coast Guard Captain of the Port. The Captain of the Port will
ensure that small entities are able to operate in the area where the
event is occurring by requesting permission from the Coast Guard Patrol
Commander. Vessels may transit through the regulated area with the
permission of the Patrol Commander. In some cases, vessels will be able
to safely transit around the regulated area. Before the enforcement
period, the Coast Guard will issue maritime advisories so mariners can
adjust their plans accordingly.
    If you think that your business, organization, or governmental
jurisdiction qualifies as a small entity and that this rule would have
a significant economic impact on it, please submit a comment (see
ADDRESSES) explaining why you think it qualifies and how and to what
degree this rule would economically affect it.

3. Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this proposed rule. If the rule would affect
your small business, organization, or governmental jurisdiction and you
have questions concerning its provisions or options for compliance,
please contact the person listed in the FOR FURTHER INFORMATION
CONTACT, above. The Coast Guard will not retaliate against small
entities that question or complain about this proposed rule or any
policy or action of the Coast Guard.

4. Collection of Information

    This proposed rule will not call for a new collection of
information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520).

5. Federalism

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government. We have analyzed this proposed rule under that Order and
determined that this rule does not have implications for federalism.

6. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to contact the person listed in the FOR FURTHER
INFORMATION CONTACT section to coordinate protest activities so that
your message can be received without jeopardizing the safety or
security of people, places or vessels.

7. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this proposed rule would not
result in such an expenditure, we do discuss the effects of this rule
elsewhere in this preamble.

8. Taking of Private Property

    This proposed rule would not cause a taking of private property or
otherwise have taking implications under Executive Order 12630,
Governmental Actions and Interference with Constitutionally Protected
Property Rights.

9. Civil Justice Reform

    This proposed rule meets applicable standards in sections 3(a) and
3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize
litigation, eliminate ambiguity, and reduce burden.

10. Protection of Children From Environmental Health Risks

    We have analyzed this proposed rule under Executive Order 13045,
Protection of Children from Environmental Health Risks and Safety
Risks. This rule is not an economically significant rule and would not
create an environmental risk to health or risk to safety that might
disproportionately affect children.

11. Indian Tribal Governments

    This proposed rule does not have tribal implications under
Executive Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it would not have a substantial direct effect on
one or more Indian tribes, on the relationship between the Federal
Government and Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes.

12. Energy Effects

    This proposed rule is not a ``significant energy action'' under
Executive Order 13211, Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use.

13. Technical Standards

    This proposed rule does not use technical standards. Therefore, we
did not consider the use of voluntary consensus standards.

14. Environment

    We have analyzed this proposed rule under Department of Homeland
Security Management Directive 023-01 and Commandant Instruction
M16475.lD, which guide the Coast Guard in complying with the National
Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and
have made a preliminary determination that this action is one of a
category of actions that do not individually or cumulatively have a
significant effect on the human environment. This proposed rule
involves implementation of regulations within 33 CFR Part 100
applicable to organized marine events on the navigable waters of the
United States that could negatively impact the safety of waterway users
and shore side activities in the event area. The category of water
activities includes but is not limited to sail boat regattas, boat
parades, power boat racing, swimming events, crew racing, canoe and
sail board racing. This rule is categorically excluded from further
review under paragraph 34(h) of Figure 2-1 of the Commandant
Instruction. A preliminary environmental analysis checklist supporting
this determination and a Categorical Exclusion Determination are
available in the docket where indicated under ADDRESSES. We seek any
comments or information that may lead to the discovery of a significant
environmental impact from this proposed rule.

List of Subjects in 33 CFR Part 100

    Marine safety, Navigation (water), Reporting and recordkeeping
requirements, Waterways.

    For the reasons discussed in the preamble, the Coast Guard proposes
to amend 33 CFR part 100 as follows:

PART 100--SAFETY OF LIFE ON NAVIGABLE WATERS

0
1. The authority citation for part 100 continues to read as follows:

    Authority:  33 U.S.C. 1233.

0
2. In the Table to Sec.  100.501:
0
a. Suspend line No. (b.)17, from October 25, 2014 to November 1, 2014;
and

0
b. On November 8, 2014, add line No. (b.)25 to the Table to Sec.
100.501 to read as follows:

Sec.  100.501  Special Local Regulations; Marine Events in the Fifth
Coast Guard District.

* * * * *
    Table To Sec.  100.501.--All coordinates listed in the Table to
Sec.  100.501 reference Datum NAD 1983.

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         No.                   Date                  Event               Sponsor                Location
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
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                                  (b.) Coast Guard Sector Baltimore--COTP Zone
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
25...................  November 8, 2014....  MRE Tug of War......  Maritime Republic    The waters of Spa Creek
                                                                    of Eastport.         from shoreline to
                                                                                shoreline, extending
                                                                                400 feet from either
                                                                                side of a rope spanning
                                                                                Spa Creek from a
                                                                                position at latitude
                                                                                38[deg]58'36.9'' N,
                                                                                longitude
                                                                                076[deg]29'03.8'' W on
                                                                                the Annapolis shoreline
                                                                                to a position at
                                                                                latitude
                                                                                38[deg]58'26.4'' N,
                                                                                longitude
                                                                                076[deg]28'53.7'' W on
                                                                                the Eastport shoreline.

                                                  * * * * * * *
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    Dated: August 28, 2014.
K.C. Kiefer,
Captain, U.S. Coast Guard, Captain of the Port Baltimore.
[FR Doc. 2014-21969 Filed 9-18-14; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register: August 31, 2010 (Volume 75, Number 168)]
[Notices]
[Page 53292-53294]
[DOCID:fr31au10-50]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings No. 1

August 23, 2010.
    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER00-2815-000.
    Applicants: Wheelabrator Shasta Energy Company Inc.
    Description: Response to request of FERC staff of Wheelabrator
Shasta Energy Company Inc.
    Filed Date: 08/20/2010.
    Accession Number: 20100820-5134.
    Comment Date: 5 p.m. Eastern Time on Friday, September 10, 2010.

    Docket Numbers: ER05-1232-024; ER07-1358-014.
    Applicants: J.P. Morgan Ventures Energy Corporation.
    Description: J.P. Morgan Ventures Energy Corporation and BE
Louisiana LLC submit Second Supplement to Updated Market Power Analysis
and Order No. 697 Compliance Filing.
    Filed Date: 08/17/2010.
    Accession Number: 20100817-5123.
    Comment Date: 5 p.m. Eastern Time on Tuesday, September 07, 2010.

    Docket Numbers: ER06-1399-007.
    Applicants: Sunbury Generation LP.
    Description: Supplemental Information of Sunbury Generation LP.
    Filed Date: 08/23/2010.
    Accession Number: 20100823-5092.
    Comment Date: 5 p.m. Eastern Time on Monday, September 13, 2010.

    Docket Numbers: ER09-1650-001; OA09-32-001.
    Applicants: BP Wind Energy North America Inc.
    Description: CFA Parties submits amendment to the Common Facilities
Agreement, effective 8/18/10.
    Filed Date: 08/17/2010.
    Accession Number: 20100818-0201.
    Comment Date: 5 p.m. Eastern Time on Tuesday, September 07, 2010.

    Docket Numbers: ER10-895-005.
    Applicants: Detroit Edison Company.
    Description: The Detroit Edison Company submits Notice of
Cancellation.
    Filed Date: 08/12/2010.
    Accession Number: 20100812-0208.
    Comment Date: 5 p.m. Eastern Time on Thursday, September 02, 2010.

    Docket Numbers: ER10-1400-000.
    Applicants: Midwest Independent Transmission System Operator, Inc.
    Description: Response to Deficiency Letter of Midwest Independent
System Transmission Operator, Inc.
    Filed Date: 08/18/2010.
    Accession Number: 20100818-5024.
    Comment Date: 5 p.m. Eastern Time on Wednesday, September 08, 2010.

    Docket Numbers: ER10-1466-002.
    Applicants: Community Power & Utility LLC.
    Description: Community Power & Utility LLC submits Amended Petition
for Acceptance of Initial Tariff, Waivers and Blanket Authority.
    Filed Date: 08/18/2010.
    Accession Number: 20100819-0208.
    Comment Date: 5 p.m. Eastern Time on Wednesday, September 08, 2010.

    Docket Numbers: ER10-1805-001.
    Applicants: The Connecticut Light and Power Company.
    Description: The Connecticut Light and Power Company submits tariff
filing per 35: PSNH Compliance Baseline Filing of Market-Based Tariff
Under Order No. 714 to be effective 7/19/2010.
    Filed Date: 08/20/2010.
    Accession Number: 20100820-5142.
    Comment Date: 5 p.m. Eastern Time on Friday, September 10, 2010.

    Docket Numbers: ER10-1808-001.
    Applicants: Western Massachusetts Electric Company.
    Description: Western Massachusetts Electric Company submits tariff
filing per 35: WMECO Compliance Baseline Filing of Market-Based Tariff
Under Order No. 714 to be effective 7/19/2010.
    Filed Date: 08/20/2010.
    Accession Number: 20100820-5146.
    Comment Date: 5 p.m. Eastern Time on Friday, September 10, 2010.

    Docket Numbers: ER10-1810-001.
    Applicants: E. I. du Pont de Nemours and Company.
    Description: E. I. du Pont de Nemours and Company submits tariff
filing per 35.17(b): Amendment to DuPont MBR Tariff to be effective 9/
30/2010.
    Filed Date: 08/20/2010.
    Accession Number: 20100820-5053.
    Comment Date: 5 p.m. Eastern Time on Friday, September 10, 2010.

    Docket Numbers: ER10-1879-001.
    Applicants: Wabash Valley Power Association, Inc.
    Description: Wabash Valley Power Association, Inc. submits tariff
filing per 35: WVPA Baseline Formulary Rate Tariff to be effective 8/
20/2010.
    Filed Date: 08/20/2010.
    Accession Number: 20100820-5141.
    Comment Date: 5 p.m. Eastern Time on Friday, September 10, 2010.

    Docket Numbers: ER10-2111-001.
    Applicants: MidAmerican Energy Company.
    Description: MidAmerican Energy Company submits revisions to Open
Access Transmission Tariff.
    Filed Date: 08/20/2010.
    Accession Number: 20100823-0201.
    Comment Date: 5 p.m. Eastern Time on Friday, September 10, 2010.

    Docket Numbers: ER10-2151-001.
    Applicants: Windstar Energy, LLC.
    Description: Windstar Energy, LLC submits Original Sheet No 1 to
FERC Electric Tariff, Original Volume No 1, effective 9/5/10.
    Filed Date: 08/18/2010.
    Accession Number: 20100819-0209.
    Comment Date: 5 p.m. Eastern Time on Wednesday, September 01, 2010.

    Docket Numbers: ER10-2259-000.
    Applicants: Allegheny Energy Supply Company, LLC.
    Description: Allegheny Energy Supply Co, LLC submits a request for

authorization to make wholesale power sales to an affiliate.
    Filed Date: 08/17/2010.
    Accession Number: 20100817-0213.
    Comment Date: 5 p.m. Eastern Time on Tuesday, September 07, 2010.

    Docket Numbers: ER10-2279-000.
    Applicants: PacifiCorp.
    Description: PacifiCorp submits a Notice of Termination for First
Revised Service Agreement No. 357.
    Filed Date: 08/18/2010.
    Accession Number: 20100818-0205.
    Comment Date: 5 p.m. Eastern Time on Wednesday, September 08, 2010.

    Docket Numbers: ER10-2284-000.
    Applicants: National Grid Generation LLC.
    Description: National Grid Generation LLC submits filing containing
certain information re its Pension and Other Post Employment Benefits
Costs for the year ending 12/31/10.
    Filed Date: 08/19/2010.
    Accession Number: 20100819-0205.
    Comment Date: 5 p.m. Eastern Time on Thursday, September 09, 2010.

    Docket Numbers: ER10-2285-000.
    Applicants: Central Maine Power Company.
    Description: Central Maine Power Company submits tariff filing per
35.12: CMP Baseline eTariff Filing to be effective 8/19/2010.
    Filed Date: 08/20/2010.
    Accession Number: 20100820-5021.
    Comment Date: 5 p.m. Eastern Time on Friday, September 10, 2010.

    Docket Numbers: ER10-2286-000.
    Applicants: PJM Interconnection, LLC
    Description: PJM Interconnection, LLC submits an executed Wholesale
Market Participation Agreement with Alethea Cleantech Advisors, LLC and
Public Service Electric & Gas Co executed on 7/21/10.
    Filed Date: 08/20/2010.
    Accession Number: 20100820-0203.
    Comment Date: 5 p.m. Eastern Time on Friday, September 10, 2010.

    Docket Numbers: ER10-2287-000.
    Applicants: Unitil Power Corp.
    Description: Unitil Power Corp. submits Notice of Cancellation of
its FERC Electric Tariff, Third Revised Volume 3.
    Filed Date: 08/19/2010.
    Accession Number: 20100820-0204.
    Comment Date: 5 p.m. Eastern Time on Thursday, September 09, 2010.

    Docket Numbers: ER10-2288-000.
    Applicants: Optim Energy Marketing LLC.
    Description: Optim Energy Marketing LLC submits tariff filing per
35.12: Optim Energy Marketing MBR Baseline to be effective 8/20/2010.
    Filed Date: 08/20/2010.
    Accession Number: 20100820-5063.
    Comment Date: 5 p.m. Eastern Time on Friday, September 10, 2010.

    Docket Numbers: ER10-2289-000.
    Applicants: UniSource Energy Development Company.
    Description: UniSource Energy Development Company submits tariff
filing per 35.12: Baseline Filing for UniSource Energy Development
Company MBR Tariff to be effective 8/23/2010.
    Filed Date: 08/20/2010.
    Accession Number: 20100820-5073.
    Comment Date: 5 p.m. Eastern Time on Friday, September 10, 2010.

    Docket Numbers: ER10-2290-000.
    Applicants: Avista Corporation.
    Description: Avista Corporation submits its baseline tariff filing
to FERC Electric Tariff, Volume No. 9, Version 8.0.0 et al., to be
effective 8/20/2010.
    Filed Date: 08/20/2010.
    Accession Number: 20100820-5075.
    Comment Date: 5 p.m. Eastern Time on Friday, September 10, 2010.

    Docket Numbers: ER10-2291-000.
    Applicants: Westmoreland Partners.
    Description: Westmoreland Partners submits tariff filing per 35.12:
Baseline Market-Based Rates to be effective 8/20/2010.
    Filed Date: 08/20/2010.
    Accession Number: 20100820-5112.
    Comment Date: 5 p.m. Eastern Time on Friday, September 10, 2010.

    Docket Numbers: ER10-2292-000.
    Applicants: Entergy Arkansas, Inc.
    Description: Entergy Arkansas, Inc. submits tariff filing per
35.13(a)(2)(iii): ETEC 9th Rev. NITSA to be effective 8/1/2010.
    Filed Date: 08/20/2010.
    Accession Number: 20100820-5143.
    Comment Date: 5 p.m. Eastern Time on Friday, September 10, 2010.

    Docket Numbers: ER10-2293-000.
    Applicants: California Independent System Operator Corporation.
    Description: California Independent System Operator Corporation
submits tariff filing per 35: 2010-08-23 CAISO Scarcity Pricing
Compliance to be effective 12/14/2010.
    Filed Date: 08/23/2010.
    Accession Number: 20100823-5068.
    Comment Date: 5 p.m. Eastern Time on Monday, September 13, 2010.

    Docket Numbers: ER10-2294-000.
    Applicants: ORNI 18, LLC.
    Description: ORNI 18, LLC submits tariff filing per 35.12: ORNI 18
Baseline MBR Filing to be effective 8/17/2010.
    Filed Date: 08/23/2010.
    Accession Number: 20100823-5071.
    Comment Date: 5 p.m. Eastern Time on Monday, September 13, 2010.

    Docket Numbers: ER10-2295-000.
    Applicants: WSPP Inc.
    Description: WSPP Inc. submits tariff filing per 35.13(a)(2)(iii):
Submission of New Schedules D and E to WSPP Agreement to be effective
11/1/2010.
    Filed Date: 08/23/2010.
    Accession Number: 20100823-5085.
    Comment Date: 5 p.m. Eastern Time on Monday, September 13, 2010.

    Docket Numbers: ER10-2296-000.
    Applicants: Hermiston Power, LLC.
    Description: Hermiston Power, LLC submits tariff filing per
35.13(a)(2)(iii): Hermiston Power, LLC--BPA Transmission Rights Filing
to be effective 8/24/2010.
    Filed Date: 08/23/2010.
    Accession Number: 20100823-5104.
    Comment Date: 5 p.m. Eastern Time on Monday, September 13, 2010.

    Docket Numbers: ER10-2297-000.
    Applicants: California Independent System Operator Corporation.
    Description: California Independent System Operator Corporation
submits tariff filing per 35.13(a)(2)(iii): 2010-08-23 CAISO CRR Credit
Provisions Amendment to be effective 11/1/2010.
    Filed Date: 08/23/2010.
    Accession Number: 20100823-5106.
    Comment Date: 5 p.m. Eastern Time on Monday, September 13, 2010.

    Docket Numbers: ER10-2298-000.
    Applicants: Enserco Energy Inc.
    Description: Enserco Energy Inc. submits tariff filing per 35.12:
MBR Application of Enserco Energy LLC to be effective 9/1/2010.
    Filed Date: 08/23/2010.
    Accession Number: 20100823-5107.
    Comment Date: 5 p.m. Eastern Time on Monday, September 13, 2010.

    Take notice that the Commission received the following electric
securities filings:

    Docket Numbers: ES10-54-000.
    Applicants: MDU Resources Group, Inc.
    Description: Application of MDU Resources Group, Inc. under New
Docket for authority to issue up to $1 billion worth of various
securities for the next 2 years.
    Filed Date: 08/19/2010.
    Accession Number: 20100819-5050.
    Comment Date: 5 p.m. Eastern Time on Thursday, September 09, 2010.

    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>.

Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2010-21654 Filed 8-30-10; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: August 30, 2006 (Volume 71, Number 168)]
[Rules and Regulations]
[Page 51510-51516]
[DOCID:fr30au06-20]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2005-0537; FRL-8086-2]

Ethofumesate; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for combined residues
of the herbicide, ethofumesate in or on carrot, roots (with regional
restrictions for use in the States of Washington and Oregon), beet,
garden, tops and beet, garden, roots; onion, bulb; garlic, bulb;
shallot, bulb; and shallot, fresh leaves. The Interregional Research
Project 4 (IR-4), 681 Highway 1 South, North Brunswick, NJ
08902-3390 requested these tolerances under the Federal Food, Drug, and
Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act of
1996 (FQPA).

DATES: This regulation is effective August 30, 2006. Objections and
requests for hearings must be received on or before October 30, 2006,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2005-0537. All documents in the
docket are listed in the index for the docket. Although listed in the
index, some information is not publicly available, e.g., Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly

available only in hard copy form. Publicly available docket materials
are available in the electronic docket at http://www.regulations.gov,

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

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

I. General Information

A. Does this Action Apply to Me?

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

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

    In addition to accessing an electronic copy of this Federal
Register document through the electronic docket at http://www.regulations.gov
, you may access this Federal Register document

electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr. You may also access a

frequently updated electronic version of 40 CFR part 180 through the
Government Printing Office's pilot e-CFR site at http://www.gpoaccess.gov/ecfr.
 To access the OPPTS Harmonized Guidelines

referenced in this document, go directly to the guidelines at http://www.epa.gpo/opptsfrs/home/guidelin.htm

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of the FFDCA, as amended by the FQPA, any
person may file an objection to any aspect of this regulation and may
also request a hearing on those objections. The EPA procedural
regulations which govern the submission of objections and requests for
hearings appear in 40 CFR part 178. You must file your objection or
request a hearing on this regulation in accordance with the
instructions provided in 40 CFR part 178. To ensure proper receipt by
EPA, you must identify docket ID number EPA-HQ-OPP-2005-0537 in the
subject line on the first page of your submission. All requests must be
in writing, and must be mailed or delivered to the Hearing Clerk on or
before October 30, 2006.
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit your copies, identified by docket ID
number EPA-HQ-OPP-2005-0537, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.

Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Building), 2777 S. Crystal Drive, Arlington, VA. Deliveries are only
accepted during the Docket's normal hours of operation (8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays). Special
arrangements should be made for deliveries of boxed information. The
Docket telephone number is<PHONE_NUMBER>.

II. Background and Statutory Findings

    In the Federal Register of March 22, 2006 (71 FR 14522) (FRL-7767-
8), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of (pesticide petitions (PP)
3E6564, 3E6565 and 5E6914) by IR-4, 681 Highway 1 South, North
Brunswick, NJ 08902-3390 on behalf of the registrant, Bayer
CropScience. The petition requested that 40 CFR 180.345 be amended by
establishing tolerances for combined residues of the herbicide
ethofumesate (2-ethoxy -2, 3-dihydro-3, 3-dimethyl-5-benzofuranyl
methanesulfonate) and its metabolites 2-hydroxy-2,3-dihydro-3,3-
dimethyl-5-benzofuranyl methanesulfonate and 2,3-dihydro-3,3-dimethyl-
2-oxo-5-benzofuranyl methanesulfonate (both calculated as the parent
compound) in or on the raw agricultural commodities: Carrots (with
regional restrictions for use in the States of Washington and Oregon)
at 10 parts per million (ppm) (PP 3E6565), garden beets tops at 4 ppm,
garden beet roots at 0.5 ppm (PP 3E6564), onion, dry bulb at 0.30 ppm
(PP 5E6914), garlic, bulb at 0.30 ppm (PP 5E6914), and shallot at 0.30
ppm (PP 5E6914). That notice included a summary of the petitions
prepared by Bayer CropScience, P. O. Box 12014, 2 T. W. Alexander
Drive, Research Triangle Park, NC 27709, the registrant. There were no
comments received in response to the notice of filing.
    Supporting documents including the Reregistration Eligibility
Decision (RED) for Ethofumesate, EPA 738-R-05-010, Sept. 2005, can be
viewed on-line along with the Agency's Human Health Risk Assessment of
ethofumesate and other supporting documents at http://www.regulations.gov

under the index of the docket for this action, Docket ID number: EPA-
HQ-OPP-2005-0537. The Agency's reregistration and tolerance
reassessment of ethofumesate are completed. Due to its uses, risks, and
other factors, ethofumesate was reviewed/reassessed through the
modified 4-Phase process as outlined in the Federal Register on May 14,
2004 (69 FR 26819)(FRL-7357-9). Through this process, EPA worked
extensively with stakeholders and the public to reach the regulatory
decisions for ethofumesate.
    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will

result from aggregate exposure to the pesticide chemical residue,
including all anticipated dietary exposures and all other exposures for
which there is reliable information.'' This includes exposure through
drinking water and in residential settings, but does not include
occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to
give special consideration to exposure of infants and children to the
pesticide chemical residue in establishing a tolerance and to ``ensure
that there is a reasonable certainty that no harm will result to
infants and children from aggregate exposure to the pesticide chemical
residue....''
    EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion of the
regulatory requirements of section 408 of the FFDCA and a complete
description of the risk assessment process, see http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm
.

III. Aggregate Risk Assessment and Determination of Safety

    Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has sufficient data to assess the hazards of and to
make a determination on aggregate exposure, consistent with section
408(b)(2) of FFDCA, for tolerances for combined residues of
ethofumesate on: Carrot (with regional restrictions for use in
Washington and Oregon) at 7.0 ppm, beet, garden, tops at 4.0 ppm, beet,
garden, roots at 0.5 ppm, onion, dry bulb at 0.25 ppm, garlic, bulb at
0.25 ppm, and shallot at 0.25 ppm. It can be noted that the tolerance
level for certain commodities was revised, based on current data
evaluations and differ from the proposed level presented in the Notice
of Filing on March 22, 2006 or as recommended in the RED for
ethofumesate. These revisions include: Carrot tolerance at 7.0 ppm,
reduced from 10.0 ppm; and garlic, bulb; onion, dry bulb and shallot
tolerances set at 0.25 ppm, reduced from 0.30 ppm. EPA's assessment of
exposures and risks associated with establishing the tolerance follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered their
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. Specific information on the studies received and the nature
of the toxic effects caused by ethofumesate as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at
http://www.regulations.gov.

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no
appreciable risk, the dose at the NOAEL from the toxicology study
identified as appropriate for use in risk assessment is used to
estimate the toxicological level of concern (LOC). However, the LOAEL
is sometimes used for risk assessment if no NOAEL was achieved in the
toxicology study selected. An uncertainty factor (UF) is applied to
reflect uncertainties inherent in the extrapolation from laboratory
animal data to humans and in the variations in sensitivity among
members of the human population as well as other unknowns.
    The linear default risk methodology (Q*) is the primary method
currently used by the Agency to quantify non-threshold hazards such as
cancer. The Q* approach assumes that any amount of exposure will lead
to some degree of cancer risk, estimates risk in terms of the
probability of occurrence of additional cancer cases. More information
can be found on the general principles EPA uses in risk
characterization at http://www.epa.gov/pesticides/health/human.htm.

    A summary of the toxicological endpoints for ethofumesate used for
human risk assessment can be found in the index of this document,
Docket ID number EPA-HQ-OPP-2005-0537, entitled, ``Human Health Risk
Assessment for Proposed Uses on Onion, Bulb'', (Table 3.4.15) (dated
April 24, 2006).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. Tolerances have been
established (40 CFR 180.345 for the combined residues of ethofumesate,
in or on a variety of raw agricultural commodities; plant commodities
range from 0.1 ppm in/on sugar beet roots to 1.0 ppm in/on sugar beet
tops and grass straw. Tolerances on animal commodities including fat,
meat and meat byproducts are set at 0.05 ppm. A process feeds tolerance
in sugar beet molasses is set at 0.5 ppm. Risk assessments were
conducted by EPA to assess dietary exposures from ethofumesate in food
as follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure.
    No appropriate endpoint was identified for the general population
and infants since no such effects were identified in the toxicological
studies for ethofumesate; therefore, a quantitative acute dietary
exposure assessment was not conducted for these populations. For
females, 13 plus years of age, in conducting the acute dietary (food +
water) exposure assessment, EPA used the Dietary Exposure Evaluation
Model software with the Food Commodity Intake Database (DEEM-FCID(\TM\)
Version 2.03), which incorporates food consumption data as reported by
respondents in the USDA 1994-1996 and 1998 Nationwide Continuing
Surveys of Food Intake by Individuals (CSFII), and accumulated exposure
to the chemical for each commodity. The following assumptions were made
for the acute exposure assessments: A conservative acute dietary
assessment was performed using tolerance level residues and 100 % crop
treated (PCT) in the assessment.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the DEEM-FCID\TM\. The following assumptions were
made for the chronic exposure assessments: A conservative chronic
dietary (food + water) assessment was performed using tolerance level
residues and 100 PCT.
    iii. Cancer. Ethofumesate is classified as ``not likely to be a
human carcinogen,'' based on bioassays in the rat and the mouse. An
exposure assessment for the purpose of assessing cancer risk is not
needed.
    2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring exposure data to complete a comprehensive dietary
exposure analysis and risk assessment for ethofumesate in drinking
water. Because the Agency does not have comprehensive monitoring data,
drinking water concentration estimates are made by reliance on
simulation or modeling taking into account data on the physical
characteristics of ethofumesate. Further information regarding EPA
drinking water models used in pesticide exposure assessment can be
found http://www.epa.gov/oppefed1/models/water/index. Typically EPA

evaluates the potential for human exposure to pesticides in drinking
water through an assessment of available surface water and ground water
monitoring data and modeling.

For ethofumesate, no monitoring data were available for use in this
drinking water assessment. Therefore, potential human exposures to
ethofumesate were evaluated through modeling. Estimated exposure
concentrations (EECs) in surface water were calculated using Pesticide
Root Zone Model/Exposure Analyses Modeling System (PRZM/EXAMS). Ground
water concentrations were modeled using screening concentration in
ground water (SCI-GROW) (version 2.3). Drinking water residues were
then incorporated into the DEEM-FCID(\TM\) into the food categories
``water, direct, all sources'' and ``water, indirect, all sources.''
The Agency concluded that degradates of ethofumesate are of
toxicological equivalence to the parent. Because these degradates were
detected in environmental fate studies in relatively low amounts (10%),
only the parent needs to be assessed for drinking water.
    Based on the PRZM/EXAMS - Index Reservoir and SCI-GROW models, the
estimated environmental concentrations (EECs) of ethofumesate for acute
exposures are estimated to be 154 parts per billion (ppb) for surface
water and 8.4 ppb for ground water. The EECs for chronic exposures are
estimated to be 45.5 ppb for for surface water and 8.4 ppb for ground
water. Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model (DEEM-FCID\TM\). For the acute
assessment, the peak concentration of 154 ppb was used to access the
contribution to drinking water; for the chronic assessment, the annual
mean value of 45.5 ppb was used to access the contribution to drinking
water.
    3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets).
    Ethofumesate is currently registered for use on the following
residential non-dietary sites: Turf grasses/lawns. The risk assessment
was conducted using the following residential exposure assumptions: All
ethofumesate products are intended for either agricultural use or
require professional application for ornamental turf. For potential
ethofumesate residential post-application exposure, the Agency
conducted screening level calculations on the scenarios most likely to
result in highest possible exposure to this herbicide. The other
aspects of the turf exposure scenario involve calculating dose from
non-dietary ingestion that arises from the hand-to-mouth, object-to-
mouth and soil ingestion pathways. These processes are:
    For toddlers: Incidental ingestion (hand-to-mouth);
    Incidental ingestion (turf-to-mouth);
    Incidental ingestion (soil-to-mouth);
    Incidental dermal;
    For adults: Jazzercise (on treated turf).
    EPA believes that this screening level assessment will be
protective of other possible residential exposures to ethofumesate such
as golfing, and mowing the lawn. Exposures were calculated by
considering the potential sources of exposure then calculating dermal
exposure, and risks.
    The Agency calculated Margin of Exposure (MOE)s for each exposure
pathway and for all pathway combinations.
    4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of the FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
    Unlike other pesticides for which EPA has followed a cumulative
risk approach based on a common mechanism of toxicity, EPA has not made
a common mechanism of toxicity finding as to ethofumesate and any other
substances and ethofumesate does not appear to produce a toxic
metabolite produced by other substances. For the purposes of this
tolerance action, therefore, EPA has not assumed that ethofumesate has
a common mechanism of toxicity with other substances. For information
regarding EPA's efforts to determine which chemicals have a common
mechanism of toxicity and to evaluate the cumulative effects of such
chemicals, see the policy statements released by EPA's Office of
Pesticide Programs concerning common mechanism determinations and
procedures for cumulating effects from substances found to have a
common mechanism on EPA's website at http://www.epa.gov/pesticides/cumulative
.

D. Safety Factor for Infants and Children

    1. In general. Section 408 of FFDCA provides that EPA shall apply
an additional tenfold margin of safety for infants and children in the
case of threshold effects to account for prenatal and postnatal
toxicity and the completeness of the database on toxicity and exposure
unless EPA determines based on reliable data that a different margin of
safety will be safe for infants and children. Margins of safety are
incorporated into EPA risk assessments either directly through use of a
MOE analysis or through using uncertainty (safety) factors in
calculating a dose level that poses no appreciable risk to humans. In
applying this provision, EPA either retains the default value of 10X
when reliable data do not support the choice of a different factor, or,
if reliable data are available, EPA uses a different additional safety
factor value based on the use of traditional UFs and/or special FQPA
safety factors, as appropriate.
    2. Prenatal and postnatal sensitivity. The Agency determined based
on the weight-of-the-evidence considerations that there are no concerns
or uncertainties for prenatal and/or postnatal toxicity resulting from
exposure to ethofumesate. There is evidence for increased quantitative
susceptibility following in utero exposure to rabbits. At 300
milligrams/kilograms/day (mg/kg/day), no maternal toxicity was reported
but developmental toxicity was observed as increased resorptions, post-
implantation loss and skeletal abnormalities (incomplete ossification
of vertebral arches). No evidence of increased susceptibility was
observed in the rat in either the developmental or reproductive
toxicity study. In the rat developmental toxicity study, no
developmental effects were reported at the highest dose tested (limit
dose of 1,000 mg/kg/day). In the 3-generation rat reproductive toxicity
study, maternal, reproductive and offspring toxicity were not observed
at any dose tested up to 5,000 ppm (396.8 and 462.5 mg/kg/day, males
and females, respectively).
    The Agency concluded that although increased prenatal quantitative
susceptibility was observed in the rabbit developmental toxicity study,
there is no concern that the risk assessment will not adequately
safeguard against potential prenatal and postnatal toxicity because the
developmental toxicity NOAELs/LOAELs are well characterized and are
used as endpoints for risk assessment for the appropriate population
subgroups.
    3. Conclusion. The toxicity database for ethofumesate is adequate
in terms of endpoint studies and dose response information to
characterize any potential prenatal or postnatal risk for infants and
children. However, a 28-day inhalation toxicity study has been required
to assess inhalation exposure, due to the potential for inhalation
exposure during application. In the absence of this study, the
inhalation exposure used a 100% default assumption. Additionally, a
dermal

absorption (or penetration) study to determine the dermal absorption
potential has been required since data on dermal penetration of
ethofumesate are unavailable at this time. A default assumption of 100%
dermal absorption was selected due to the unavailability of comparative
oral and dermal toxicity data with a common endpoint in the same
species. There are several uncertainties present in this risk
assessment:
    i. While ethofumesate toxicological databases are substantially
complete, confidence in several areas of the risk assessment would
improve with more data. In addition to the requirement for the 28-day
inhalation study, data are needed for residue chemistry (i.e, a new
cattle feeding study and recovery data for metabolites) as well as for
metabolism (i.e. extensive field rotational crop studies).
    ii. The extrapolation from oral studies for both the dermal and
inhalation portions of the risk assessment in conjunction with a dose
spacing concern for the developmental study used to develop residential
or occupational assessments for women 13+ years render a highly
conservative analysis.
    iii. There are uncertainties associated with the drinking water
assessment but the limitations related to modeling drinking water
exposure did not contribute to an overall concern because the highest
aggregate food and water values did not exceed Agency's LOC. Based on
the available data, EPA is confident that the values used in this risk
assessment are protective. No increase in susceptibility of rats was
seen in developmental studies or in a rat 3-generation reproductive
study. Although increased prenatal quantitative sensitivity was
observed in the rabbit developmental toxicity study, the developmental
toxicity NOAELs and LOAELs are well characterized and are used as
endpoints for risk assessment for the appropriate population subgroups.
The Agency evaluated the potential for increased susceptibility of
infants and children from exposure to ethofumesate as required by the
FQPA of 1996. All doses for risk assessment purposes were assessed
using UFs of 10X for interspecies extrapolation and 10X for
intraspecies variability. Acceptable developmental and reproduction
studies have been submitted and reviewed.
    The Agency evaluated the quality of the exposure data to determine
if the the special FQPA (10X) Safety Factor can be reduced based on the
following considerations:
    Dietary food exposure assessment utilizes proposed tolerance level
or higher residues and 100 PCT information for all commodities. By
using these screening-level assessments, chronic exposures/risks will
not be underestimated.
    Dietary drinking water assessment (Tier 1 estimates) utilizes
values generated by model and associated modeling parameters which are
designed to provide conservative, health protective, high-end estimates
of water concentrations.
    Residential exposure assessment utilizes: Activity specific
transfer coefficients and chemical-specific turf transferable residue
(TTR) studies for the post-application scenario. The refined
residential assessment is based on reliable data and is unlikely to
underestimate exposure/risk.
    The Agency concluded that there is no concern for prenatal and/or
postnatal toxicity resulting from exposure to ethofumesate. Therefore,
no special FQPA Safety Factor (i.e. 10X) is needed since there are no
residual uncertainties for prenatal and/or postnatal toxicity. Hence, a
Safety Factor (1X) was applied.

E. Aggregate Risks and Determination of Safety

    In examining aggregate risk, the Agency takes into account all
available reliable information concerning exposures from pesticide
residues in food and other exposures including drinking water and
potential residential exposure to pesticides from such uses as lawn
care applications (turf), golf course and others. Aggregate risk
assessment considerations must also include potential exposures from
oral, dermal and inhalation routes.
    1. Acute risk. For the acute aggregate risk scenario, food and
drinking water exposures were taken into account in the dietary
exposure assessment. The estimated dietary exposures (food and water)
for females 13-49 years, the only population subgroup of toxicological
concern identified at this time, at 4% of the acute Population Adjusted
Dose (aPAD). The contribution of food and food forms to this estimate,
at the 95th percentile, is 2.1%. A risk estimate that is less than 100%
of the aPAD, the dose at which an individual could be exposed on any
given day with no adverse health effects, does not exceed the Agency's
LOC.
    2. Chronic risk. For the chronic aggregate risk scenario, food,
drinking water, and residential exposures were taken into account.
Chronic exposure in residential settings is not expected and the
aggregate chronic assessment included food and drinking water only.
Since the dietary exposure assessment already includes the highest
chronic exposure from the drinking water modeling data, i.e., an
estimated maximum 1 in 10 year average concentration of 45.5 ppb no
further calculations are necessary. The dietary exposure estimate for
all population subgroups was < 1% of the chronic Population Adjusted
Dose (cPAD) with the most highly exposed subgroup being all infants < 1
yrs old. Risk estimates for all population subgroups are below the
Agency's LOC (100% of the cPAD).
    3. Short- and intermediate-term aggregate risk. Short- and
Intermediate-term aggregate exposure takes into account residential
exposure plus chronic exposure to food and water (considered to be a
background exposure level).
    Ethofumesate is currently registered for use that could result in
short-term residential exposure and the Agency has determined that it
is appropriate to aggregate chronic food and water and short-term
exposures for ethofumesate.
    For short- and intermediate-term assessments, the oral, dermal and
inhalation pathways can be combined due to the common toxicity endpoint
via the oral, dermal (oral equivalent) and inhalation (oral equivalent)
routes for the appropriate population of concern. For the short-and
intermediate-term aggregate risk scenarios, food, drinking water and
residential exposures are taken into account. The aggregate short- and
intermediate-term MOEs, combining food, drinking water and residential
exposures ranged from 160 for all infants < 1 yrs old to 270 for the
U.S. population. With the exception of women of child-bearing years,
residential post-application MOEs for toddlers and adults to
ethofumesate on treated turf, regardless of the pathway of exposure, do
not exceed the EPA's LOC.
    In the case of women of child-bearing years, MOEs are 73 for 1.5
pounds active ingedient/Acre (lb ai/A) application rate for turf and 27
for the 3.0 lb ai/A application rate for turf. The rate of 1.5 lb ai/A
covers the majority of uses; however, the label does permit a 3.0 lb
ai/A rate specifically for suppression of Bermuda grass in St Augustine
grass turf. While the residential postapplication scenarios for females
resulted in apparent risks of concern, the Agency believes that these
scenarios are very conservative and unlikely to occur. The
developmental endpoint used to estimate risk for females was based on a
study with a NOAEL (30 mg/kg/day) that is 10X lower than the LOAEL (300
mg/kg/day); therefore the NOAEL may be an artifact of dose selection.
Additionally, for the

residential exposures, the endpoint is oral while the assessed
exposures are dermal and conservative standard operating procedure
(SOP)-based default assumptions such as 100% dermal absorption, default
turf transferable residue dissipation assumptions, contact with turf
immediately post-treatment and maximum application rates were used in
this assessment.
    Further, it should be noted that estimated exposures are extremely
conservative due not only to assumption of 100% dermal absorption but
also because they assume exposure at levels immediately after
application, maximal levels of dermal exposure activity, maximum dermal
contact, and maximum dermal surface contact areas. Additionally,
ethofumesate has minimal lawncare and commercial turf uses, which is
the scenario where high dermal exposure activities would occur. The
predominant use is on golf courses and sod farms. High exposure
activities would likely not occur on a golf course. Ethofumesate
residues resulting from sod farm application would likely dissipate
significantly before sod was transplanted to residential or commercial
turf.
    However, to address this concern, the Agency is requiring a dermal
absorption study to permit more realistic estimation of dermal
absorption. Nonetheless, Agency scientist's consider this a highly
conservative estimate of post-application risk for the population
females 13-49 years of age exposed to ethofumesate on turf and based on
the available data, the EPA is confident that the values used in this
risk assessment are protective.
    4. Aggregate cancer risk for U.S. population. Ethofumesate is
classified as ``not likely to be a carcinogen to humans'' based on the
lack of carcinogenicity in the mouse carcinogenicity study and lack of
convincing evidence for carcinogenicity in the rat chronic toxicity/
carcinogenicity study. In addition, no evidence of genotoxicity of
ethofumesate was observed in available genotoxicity studies. Therefore,
ethofumesate is not expected to pose a cancer risk and a cancer
aggregate risk assessment was not performed.
    5. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, and to infants and children from aggregate
exposure to ethofumesate residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    A tolerance enforcement method is listed as Method I in PAM Vol. II
(Section 108.345) for determining the currently regulated residues in
plants, which include ethofumesate and its metabolites (free and
conjugated). Residues are determined using gas chromatography with
flame ionization detector (GC/FID) in the sulfur mode with an internal
standard. The reported limit of quantification(LOQ) for each analyte is
0.02 ppm.
    Aequate enforcement methodology (gas chromatography with flame
ionization detector (GC/FID)) is available to enforce the tolerance
expression. The method may be requested from: Chief, Analytical
Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft.
Meade, MD 20755-5350; telephone number:<PHONE_NUMBER>; e-mail address:
<EMAIL_ADDRESS>

B. International Residue Limits

    There is currently no Codex, Canadian, or Mexican maximum residue
levels (MRLs) established for ethofumesate, therefore there are no
international harmonization issues for this action.

V. Conclusion

    Therefore, the tolerance is established for combined residues of
ethofumesate, (2-ethoxy -2, 3-dihydro-3, 3-dimethyl-5-benzofuranyl
methanesulfonate) and its metabolites 2-hydroxy-2,3-dihydro-3,3-
dimethyl-5-benzofuranyl methanesulfonate and 2,3-dihydro-3,3-dimethyl-
2-oxo-5-benzofuranyl methanesulfonate (both calculated as the parent
compound) in or on the raw agricultural commodities: Carrot, roots
(with regional restrictions for us in the States of Washington and
Oregon) at 7.0 ppm; beet, garden, tops at 4 ppm; beet, garden, roots at
0.5 ppm; onion, bulb at 0.25 ppm; garlic, bulb at 0.25 ppm; shallot,
bulb and shallot, fresh leaves at 0.25 ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes a tolerance under section 408(d) of
FFDCA in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). Because this rule has been
exempted from review under Executive Order 12866 due to its lack of
significance, this rule is not subject to Executive Order 13211,
Actions Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May 22, 2001). This final rule does
not contain any information collections subject to OMB approval under
the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose
any enforceable duty or contain any unfunded mandate as described under
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law
104-4). Nor does it require any special considerations under Executive
Order 12898, entitled Federal Actions to Address Environmental Justice
in Minority Populations and Low-Income Populations (59 FR 7629,
February 16, 1994); or OMB review or any Agency action under Executive
Order 13045, entitled Protection of Children from Environmental Health
Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does
not involve any technical standards that would require Agency
consideration of voluntary consensus standards pursuant to section
12(d) of the National Technology Transfer and Advancement Act of 1995
(NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since
tolerances and exemptions that are established on the basis of a
petition under section 408(d) of FFDCA, such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply. The Agency hereby certifies that this rule will not
have significant negative economic impact on a substantial number of
small entities. In addition, the Agency has determined that this action
will not have a substantial direct effect on States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government, as specified in Executive Order 13132, entitled Federalism
(64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to
develop an accountable process to ensure ``meaningful and timely input
by State and local officials in the development of regulatory policies
that have federalism implications.'' ``Policies that have federalism
implications'' is defined in the Executive order to include regulations
that have ``substantial direct effects on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government.'' This final rule

directly regulates growers, food processors, food handlers and food
retailers, not States. This action does not alter the relationships or
distribution of power and responsibilities established by Congress in
the preemption provisions of section 408(n)(4) of FFDCA. For these same
reasons, the Agency has determined that this rule does not have any
``tribal implications'' as described in Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (65 FR
67249, November 6, 2000). Executive Order 13175, requires EPA to
develop an accountable process to ensure ``meaningful and timely input
by tribal officials in the development of regulatory policies that have
tribal implications.'' ``Policies that have tribal implications'' is
defined in the Executive order to include regulations that have
``substantial direct effects on one or more Indian tribes, on the
relationship between the Federal Government and the Indian tribes, or
on the distribution of power and responsibilities between the Federal
Government and Indian tribes.'' This rule will not have substantial
direct effects on tribal governments, on the relationship between the
Federal Government and Indian tribes, or on the distribution of power
and responsibilities between the Federal Government and Indian tribes,
as specified in Executive Order 13175. Thus, Executive Order 13175 does
not apply to this rule.

VII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of this final rule in the Federal Register. This final
rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

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

    Dated: August 23, 2006.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

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

PART 180--[AMENDED]

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

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

0
2. Section 180.345 is amended as follows:
    i. In paragraph (a) by designating the introductory text and table
as paragraph (a)(1) and by alphabetically adding commodities to the
table; and
    ii. Paragraph (c) is amended by adding text and a table.
    The amendments read as follows:

Sec.  180.345  Ethofumesate; tolerances for residues.

    (a) General. (1) * * *

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
Beet, garden, roots..................................                0.5
Beet, garden, tops...................................                4.0
                                * * * * *
Garlic, bulb.........................................               0.25
                                * * * * *
Onion, bulb..........................................               0.25
Shallot, bulb........................................               0.25
Shallot, fresh leaves................................               0.25
                                * * * * *
------------------------------------------------------------------------

* * * * *
    (c) Tolerances with regional registration. Tolerances with regional
registration as defined in 40 CFR 180.1(m) are established for the
combined residues of ethofumesate,(2-ethoxy -2, 3-dihydro-3, 3-
dimethyl-5-benzofuranyl methanesulfonate) and its metabolites 2-
hydroxy-2,3-dihydro-3,3-dimethyl-5-benzofuranyl methanesulfonate and
2,3-dihydro-3,3-dimethyl-2-oxo-5-benzofuranyl methanesulfonate (both
calculated as the parent compound) in or on the raw agricultural
commodities:

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
Carrot, roots........................................                7.0
------------------------------------------------------------------------

* * * * *
[FR Doc. E6-14431 Filed 8-29-06; 8:45 am]

BILLING CODE 6560-50-S


[Federal Register: January 13, 2010 (Volume 75, Number 8)]
[Notices]
[Page 1832]
[DOCID:fr13ja10-111]

=======================================================================
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SECURITIES AND EXCHANGE COMMISSION

Sunshine Act Meeting

    Notice is hereby given, pursuant to the provisions of the
Government in the Sunshine Act, Public Law 94-409, that the Securities
and Exchange Commission will hold a Closed Meeting on Monday, January
11, 2010 at 10:30 a.m.
    Commissioners, Counsel to the Commissioners, the Secretary to the
Commission, and recording secretaries will attend the Closed Meeting.
Certain staff members who have an interest in the matters also may be
present.
    The General Counsel of the Commission, or his designee, has
certified that, in his opinion, one or more of the exemptions set forth
in 5 U.S.C. 552b(c)(10) and 17 CFR 200.402(a)(10), permit consideration
of the scheduled matter at the Closed Meeting.
    Commissioner Walter, as duty officer, voted to consider the item
listed for the Closed Meeting in a closed session, and determined that
no earlier notice thereof was possible.
    The subject matter of the Closed Meeting scheduled for Monday,
January 11, 2010 will be: post argument discussion.
    At times, changes in Commission priorities require alterations in
the scheduling of meeting items.
    For further information and to ascertain what, if any, matters have
been added, deleted or postponed, please contact:
    The Office of the Secretary at<PHONE_NUMBER>.

    Dated: January 11, 2010.
Florence E. Harmon,
Deputy Secretary.
[FR Doc. 2010-592 Filed 1-11-10; 4:15 pm]
BILLING CODE 8011-01-P


[Federal Register Volume 86, Number 248 (Thursday, December 30, 2021)]
[Notices]
[Page 74426]
[FR Doc No: 2021-28338]

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

Federal Aviation Administration

[Docket No. FAA-2018-0857; Summary Notice No.-2021-0020]

Petition for Exemption; Summary of Petition Received; Overwatch
Aero, LLC

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Notice.

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

SUMMARY: This notice contains a summary of a petition seeking relief
from specified requirements of Federal Aviation Regulations. The
purpose of this notice is to improve the public's awareness of, and
participation in, the FAA's exemption process. Neither publication of
this notice nor the inclusion nor omission of information in the
summary is intended to affect the legal status of the petition or its
final disposition.

DATES: Comments on this petition must identify the petition docket
number and must be received on or before January 19, 2022.

ADDRESSES: Send comments identified by docket number FAA-2018-0857
using any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov and follow the online instructions for sending your
comments electronically.
     Mail: Send comments to Docket Operations, M-30; U.S.
Department of Transportation, 1200 New Jersey Avenue SE, Room W12-140,
West Building Ground Floor, Washington, DC 20590-0001.
     Hand Delivery or Courier: Take comments to Docket
Operations in Room W12-140 of the West Building Ground Floor at 1200
New Jersey Avenue SE, Washington, DC 20590-0001, between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays.
     Fax: Fax comments to Docket Operations at<PHONE_NUMBER>.
    Privacy: In accordance with 5 U.S.C. 553(c), DOT solicits comments
from the public to better inform its rulemaking process. DOT posts
these comments, without edit, including any personal information the
commenter provides, to http://www.regulations.gov, as described in the
system of records notice (DOT/ALL-14 FDMS), which can be reviewed at
http://www.dot.gov/privacy.
    Docket: Background documents or comments received may be read at
http://www.regulations.gov at any time. Follow the online instructions
for accessing the docket or go to the Docket Operations in Room W12-140
of the West Building Ground Floor at 1200 New Jersey Avenue SE,
Washington, DC 20590-0001, between 9 a.m. and 5 p.m., Monday through
Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: Jake Troutman,<PHONE_NUMBER>, Office
of Rulemaking, Federal Aviation Administration, 800 Independence Avenue
SW, Washington, DC 20591.
    This notice is published pursuant to 14 CFR 11.85.

Angela O. Anderson,
Acting Executive Director, Office of Rulemaking.

Petition for Exemption

    Docket No.: FAA-2018-0857.
    Petitioner: Overwatch Aero, LLC.
    Section(s) of 14 CFR Affected: Sec. Sec.  61.113(a) and (b);
91.7(a); 91.103(b)(2); 91.109; 91.151(a); 91.403(b); 91.405(a);
91.407(a)(1); 91.409(a)(1) and (2); and 91.417(a) and (b).
    Description of Relief Sought: Overwatch Aero, LLC (Overwatch) seeks
relief to operate the L3Harris Latitude HQ-90C, weighing over 55 pounds
(lbs.) with an increased weight from 121 lbs. to no more than 130 lbs.;
with approval to operate up to 1,200 feet (ft.) above ground level
(AGL) in Class G Airspace, an increase from the currently-approved 400
ft. AGL and below; a provision to allow night visual flight rules (VFR)
operations outside of areas designated as temporary flight
restrictions, which are currently limited to day VFR operations; and, a
provision to expand approved flight categories beyond active emergency
response flights.

[FR Doc. 2021-28338 Filed 12-29-21; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 79, Number 111 (Tuesday, June 10, 2014)]
[Notices]
[Pages 33198-33199]
[FR Doc No: 2014-13444]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-E-1234]

Determination of Regulatory Review Period for Purposes of Patent
Extension; STENDRA

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for STENDRA and is publishing this notice of
that determination as required by law. FDA has made the determination
because of the submission of an application to the Director of the U.S.
Patent and Trademark Office (USPTO), Department of Commerce, for the
extension of a patent which claims that human drug product.

ADDRESSES: Submit electronic comments to http://

www.regulations.gov. Submit written petitions (two copies are required)
and written comments to the Division of Dockets Management (HFA-305),
Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852. Submit petitions electronically to http://www.regulations.gov
at Docket No. FDA-2013-S-0610.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of
Management, Center for Drug Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6257, Silver
Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term
Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug
and Patent Term Restoration Act (Pub. L. 100-670) generally provide
that a patent may be extended for a period of up to 5 years so long as
the patented item (human drug product, animal drug product, medical
device, food additive, or color additive) was subject to regulatory
review by FDA before the item was marketed. Under these acts, a
product's regulatory review period forms the basis for determining the
amount of extension an applicant may receive.
    A regulatory review period consists of two periods of time: A
testing phase and an approval phase. For human drug products, the
testing phase begins when the exemption to permit the clinical
investigations of the drug becomes effective and runs until the
approval phase begins. The approval phase starts with the initial
submission of an application to market the human drug product and
continues until FDA grants permission to market the drug product.
Although only a portion of a regulatory review period may count toward
the actual amount of extension that the Director of USPTO may award
(for example, half the testing phase must be subtracted as well as any
time that may have occurred before the patent was issued), FDA's
determination of the length of a regulatory review period for a human
drug product will include all of the testing phase and approval phase
as specified in 35 U.S.C. 156(g)(1)(B).
    FDA has approved for marketing the human drug product STENDRA
(avanafil). STENDRA is indicated for the treatment of erectile
dysfunction. Subsequent to this approval, USPTO received a patent term
restoration application for STENDRA (U.S. Patent No. 6,656,935) from
Mitsubishi Tanabe Pharma Corp., and USPTO requested FDA's assistance in
determining this patent's eligibility for patent term restoration. In a
letter dated February 13, 2013, FDA advised USPTO that this human drug
product had undergone a regulatory review period and that the approval
of STENDRA represented the first permitted commercial marketing or use
of the product. Thereafter, USPTO requested that FDA determine the
product's regulatory review period.
    FDA has determined that the applicable regulatory review period for
STENDRA is 3,770 days. Of this time, 3,466 days occurred during the
testing phase of the regulatory review period, while 304 days occurred
during the approval phase. These periods of time were derived from the
following dates:
    1. The date an exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 355(i)) became
effective: January 2, 2002. FDA has verified the applicant's claim that
the date the investigational new drug application became effective was
on January 2, 2002.
    2. The date the application was initially submitted with respect to
the human drug product under section 505(b) of the FD&C Act: June 29,
2011. FDA has verified the applicant's claim that the new drug
application (NDA) for STENDRA (NDA 202276) was submitted on June 29,
2011.
    3. The date the application was approved: April 27, 2012. FDA has
verified the applicant's claim that NDA 202276 was approved on April
27, 2012.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, USPTO applies
several statutory limitations in its calculations of the actual period
for patent extension. In its application for patent extension, this
applicant seeks 1,686 days of patent term extension.
    Anyone with knowledge that any of the dates as published are
incorrect may submit to the Division of Dockets Management (see
ADDRESSES) either electronic or written comments and ask for a
redetermination by August 11, 2014. Furthermore, any interested person
may petition FDA for a determination regarding whether the applicant
for extension acted with due diligence during the regulatory review
period by December 8, 2014. To meet its burden, the petition must
contain sufficient facts to merit an FDA investigation. (See H. Rept.
857, part 1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should
be in the format specified in 21 CFR 10.30.
    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) electronic or written comments and written or
electronic petitions. It is only necessary to send one set of comments.
Identify comments with the docket number found in brackets in the
heading of this document. If you submit a written petition, two copies
are required. A petition submitted electronically must be submitted to
http://www.regulations.gov, Docket No. FDA-2013-S-0610. Comments and
petitions that have not been made publicly available on http://www.regulations.gov may be viewed in the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: June 4, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-13444 Filed 6-9-14; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 79, Number 134 (Monday, July 14, 2014)]
[Notices]
[Page 40744]
[FR Doc No: 2014-16380]

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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: RP14-1086-000.
    Applicants: Wyoming Interstate Company, L.L.C.
    Description: Request for Limited Waiver of Wyoming Interstate
Company, L.L.C.
    Filed Date: 6/30/14.
    Accession Number: 20140630-5363.
    Comments Due: 5 p.m. ET 7/10/14.

    Docket Numbers: RP14-1087-000.
    Applicants: WTG Hugoton, LP.
    Description: Annual Fuel Retention Percentage Filing 2014-2015 to
be effective 8/1/2014.
    Filed Date: 7/2/14.
    Accession Number: 20140702-5050.
    Comments Due: 5 p.m. ET 7/14/14.

    Docket Numbers: RP14-1088-000.
    Applicants: El Paso Natural Gas Company, L.L.C.
    Description: Non-Conforming Agreements Filing (TGS) to be effective
8/1/2014.
    Filed Date: 7/2/14.
    Accession Number: 20140702-5065.
    Comments Due: 5 p.m. ET 7/14/14.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    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.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings 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<PHONE_NUMBER>.

    Dated: July 3, 2014.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2014-16380 Filed 7-11-14; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 86, Number 73 (Monday, April 19, 2021)]
[Notices]
[Pages 20396-20397]
[FR Doc No: 2021-07932]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4525-DR; Docket ID FEMA-2021-0001]

Utah; Amendment No. 3 to Notice of a Major Disaster Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: This notice amends the notice of a major disaster declaration
for the State of Utah (FEMA-4525-DR), dated April 4, 2020, and related
determinations.

DATES: This amendment was issued February 2, 2021.

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, pursuant to the
President's Memorandum to Extend Federal Support to Governors' Use of
the National Guard to Respond to COVID-19 and to Increase

Reimbursement and Other Assistance Provided to States, dated January
21, 2021 and the President's Memorandum on Maximizing Assistance from
the Federal Emergency Management Agency, dated February 2, 2021 FEMA is
amending the cost-sharing arrangements regarding Federal funds provided
under the authority of the Robert T. Stafford Disaster Relief and
Emergency Assistance Act, 42 U.S.C. 5121-5207 (the ``Stafford Act'')
for all of the COVID-19 emergency and major disaster declarations. FEMA
is amending this declaration as follows:

    Federal funds for emergency protective measures (Category B),
including direct Federal assistance, under the Public Assistance
program (Section 403) are authorized at 100 percent of total
eligible costs for work performed from January 20, 2020 through
September 30, 2021.

(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.)

Robert J. Fenton,
Senior Official Performing the Duties of the Administrator, Federal
Emergency Management Agency.
[FR Doc. 2021-07932 Filed 4-16-21; 8:45 am]
BILLING CODE 9111-23-P


Reader’s Guide Fenoxaprop-p-ethyl

CRM: Kylie Rothwell

EPA/OPPTS/OPP/SRRD

Reader’s Guide to Fenoxaprop-p-ethyl Docket # EPA-HQ-2007-0437

Publication Date: August 29, 2007

EPA has created this document to provide an organizational structure to
the Fenoxaprop-p-ethyl docket. The docket index lists the caption
entries sequentially, while this document lists them by subject matter.
The Agency is providing the “Readers Guide” to allow the reader to
more easily access and navigate the various entries contained in the
Fenoxaprop-p-ethyl.

Federal Register and Docket Organizational Documents:

Docket Entry 1. Federal Register Notice:  Fenoxaprop-p-ethyl
Reregistration Review

Docket Entry 2.  Reader’s Guide to Fenoxaprop-p-ethyl Docket #
EPA-HQ-OPP-2007-0437

Docket Entry 3.  Fenoxaprop-p-ethyl Summary Document Registration
Review:  Initial Docket August 29, 2007

Docket Entry 4.  Usage Report in Support of Registration Review for the
Herbicide Fenoxaprop-p-ethyl, (PC Code 129092)

Docket Entry 5.   Ecological Incident Statement for Fenoxaprop-p-ethyl
Ecological Risk Assessment Problem Formulation

Docket Entry 6.  Review of Fenoxaprop-p-ethyl Human Health Incident
Reports