[Federal Register Volume 83, Number 81 (Thursday, April 26, 2018)]
[Proposed Rules]
[Pages 18241-18243]
[FR Doc No: 2018-08743]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2018-0239]
RIN 1625-AA00

Safety Zone; Tennessee River, Gilbertsville, KY

AGENCY: Coast Guard, DHS.

ACTION: Notice of proposed rulemaking.

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SUMMARY: The Coast Guard proposes to establish a temporary safety zone
for certain waters of the Tennessee River. This action is necessary to
provide for the safety of life on these navigable waters near Kentucky
Dam Marina, Gilbertsville, KY, during a fireworks display. This
proposed rulemaking would prohibit persons and vessels from entering
the safety zone unless authorized by the Captain of the Port Sector
Ohio Valley or a designated representative. We invite your comments on
this proposed rulemaking.

DATES: Comments and related material must be received by the Coast
Guard on or before May 29, 2018.

ADDRESSES: You may submit comments identified by docket number USCG-
2018-0239 using the Federal eRulemaking Portal at http://www.regulations.gov. See the ``Public Participation and Request for
Comments'' portion of the SUPPLEMENTARY INFORMATION section for further
instructions on submitting comments.

FOR FURTHER INFORMATION CONTACT: If you have questions about this
proposed rulemaking, call or email MST3 Joseph Stranc, Marine Safety
Unit Paducah Waterways division, U.S. Coast Guard; telephone 270-442-
1621 ext. 2124, email [email protected].

SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
COTP Captain of the Port Sector Ohio Valley
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of proposed rulemaking
Sec.  Section
U.S.C. United States Code

II. Background, Purpose, and Legal Basis

    On January 17, 2018, the Kentucky Dam Marina notified the Coast
Guard that they would be conducting a fireworks display from 7 p.m.
through 10 p.m. on June 30, 2018. The fireworks are to be launched from
the break wall of Kentucky Dam Marina. Hazards from firework displays
include accidental discharge of fireworks, dangerous projectiles, and
falling hot embers or other debris. The Captain of the Port Sector Ohio
Valley (COTP) has determined that potential hazards associated with the
fireworks display would be a safety concern for anyone within a 350-
foot radius of the break wall.
    The purpose of this rulemaking is to ensure the safety of vessels
and the navigable waters within a 350-foot radius of the fireworks
launch site before, during, and after the scheduled event. The Coast
Guard proposes this rulemaking under authority in 33 U.S.C. 1231.

III. Discussion of Proposed Rule

    The COTP proposes to establish a safety zone from 6:50 p.m. to
10:10 p.m. on June 30, 2018. The safety zone would cover all navigable
waters of the Tennessee River at mile marker (MM) 23 within 350 feet of
a break wall at Kentucky Dam Marina in Gilbertsville, KY. The duration
of the zone is intended to ensure the safety of vessels and these
navigable waters before, during, and after the scheduled fireworks
display. No vessel or person would be permitted to enter the safety
zone without obtaining permission from the COTP or a designated
representative. They may be contacted on VHF-FM Channel 16 or by phone
at 1-800-253-7465. Persons and vessels permitted to enter this safety
zone must transit at their slowest safe speed and comply with all
lawful directions issued by the COTP or a designated representative.
The COTP or a designated representative would inform the public through
broadcast notices to mariners of the enforcement period for the
temporary safety zone as well as any changes in the planned schedule.
The regulatory text we are proposing appears at the end of this
document.

IV. 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 and Executive orders and
we discuss First Amendment rights of protestors.

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. Executive Order 13771 directs agencies to control
regulatory costs through a budgeting process. This NPRM has not been
designated a ``significant regulatory action,'' under Executive Order
12866. Accordingly, the NPRM has not been reviewed by the Office of
Management and Budget (OMB), and pursuant to OMB guidance it is exempt
from the requirements of Executive Order 13771.
    This regulatory action determination is based on the size,
location, duration and time-of-day of the safety zone. Vessel traffic
would be able to safely transit around this safety zone, which would
impact a 350-foot designated area of the Tennessee River for
approximately 3 hours on one evening. Moreover, the Coast Guard would
issue a Broadcast Notice to Mariners (BNMs) via VHF-FM marine channel
16 about the zone, and the rule would allow

vessels to seek permission to enter the zone.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as
amended, requires Federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this
proposed rule would not have a significant economic impact on a
substantial number of small entities.
    While some owners or operators of vessels intending to transit the
safety zone may be small entities, for the reasons stated in section
IV.A above, this proposed rule would not have a significant economic
impact on any vessel owner or operator.
    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.
    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
section. 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.

C. Collection of Information

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

D. Federalism and Indian Tribal Governments

    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
have determined that it is consistent with the fundamental federalism
principles and preemption requirements described in Executive Order
13132.
    Also, 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. If
you believe this proposed rule has implications for federalism or
Indian tribes, please contact the person listed in the FOR FURTHER
INFORMATION CONTACT section.

E. 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.

F. Environment

    We have analyzed this proposed rule under Department of Homeland
Security Directive 023-01 and Commandant Instruction M16475.1D, which
guide the Coast Guard in complying with the National Environmental
Policy Act of 1969 (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 a safety zone lasting
approximately 3 hours that would prohibit entry within 350 feet of a
break wall. Normally, such actions are categorically excluded from
further review under paragraph L 60(a) of Appendix A, Table 1 of DHS
Instruction Manual 023-01-001-01, Rev. 01. A preliminary Record of
Environmental Consideration supporting this determination is 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.

G. 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.

V. Public Participation and Request for Comments

    We view public participation as essential to effective rulemaking,
and will consider all comments and material received during the comment
period. Your comment can help shape the outcome of this rulemaking. 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.
    We encourage you to submit comments through the Federal eRulemaking
Portal at http://www.regulations.gov. If your material cannot be
submitted using http://www.regulations.gov, contact the person in the
FOR FURTHER INFORMATION CONTACT section of this document for alternate
instructions.
    We accept anonymous comments. All comments received will be posted
without change to http://www.regulations.gov and will include any
personal information you have provided. For more about privacy and the
docket, visit http://www.regulations.gov/privacyNotice.
    Documents mentioned in this NPRM as being available in the docket,
and all public comments, will be in our online docket at http://www.regulations.gov and can be viewed by following that website's
instructions. Additionally, if you go to the online docket and sign up
for email alerts, you will be notified when comments are posted or a
final rule is published.

List of Subjects in 33 CFR Part 165

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

    For the reasons discussed in the preamble, the Coast Guard proposes
to amend 33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows:

    Authority:  33 U.S.C. 1231; 50 U.S.C. 191; 33 CFR 1.05-1, 6.04-
1, 6.04-6, and 160.5;

Department of Homeland Security Delegation No. 0170.1.

0
2. Add Sec.  165.T08-0239 to read as follows:

Sec.  165.T08-0239   Safety Zone; Ohio River, Cincinnati, OH.

    (a) Location. The following area is a safety zone: all navigable
waters of the Tennessee River at mile marker (MM) 23 within a 350-foot
radius from fireworks launch site on the Kentucky Dam Marina break wall
in Gilbertsville, KY.
    (b) Effective date. This section is effective from 6:50 p.m.
through 10:10 p.m. on June 30, 2018.
    (c) Regulations. (1) In accordance with the general regulations in
Sec.  165.23 of this part, entry into this zone is prohibited unless
authorized by the Captain of the Port Sector Ohio Valley (COTP) or a
designated representative.
    (2) Persons or vessels desiring to enter into or pass through the
zone must request permission from the COTP or a designated
representative. They may be contacted on VHF-FM Channel 16 or by phone
at 1-800-253-7465.
    (3) If permission is granted, all persons and vessels must transit
at their slowest safe speed and comply with all lawful directions
issued by the COTP or a designated representative.
    (d) Informational broadcasts. The COTP or a designated
representative will inform the public through Broadcast Notice to
Mariners (BNMs) of the enforcement period for the safety zone as well
as the date and time of enforcement.

    Dated: April 18, 2018.
M.B. Zamperini,
Captain, U.S. Coast Guard, Captain of the Port Sector Ohio Valley.
[FR Doc. 2018-08743 Filed 4-25-18; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register: September 3, 2010 (Volume 75, Number 171)]
[Rules and Regulations]
[Page 54019-54020]
[DOCID:fr03se10-6]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558

[Docket No. FDA-2010-N-0002]

New Animal Drugs for Use in Animal Feed; Ractopamine

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect approval of two supplemental new animal
drug applications (NADAs) filed by Elanco Animal Health, A Division of
Eli Lilly & Co. The supplemental NADAs provide for administering a Type
C medicated feed containing ractopamine hydrochloride as a top dress on
Type C medicated feeds containing monensin, USP, or monensin, USP, and
tylosin phosphate to cattle fed in confinement for slaughter.

DATES: This rule is effective September 3, 2010.

FOR FURTHER INFORMATION CONTACT:  Suzanne J. Sechen, Center for
Veterinary Medicine (HFV-126), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855,<PHONE_NUMBER>, e-mail:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Elanco Animal Health, A Division of Eli
Lilly & Co., Lilly Corporate Center, Indianapolis, IN 46285, filed a
supplement to NADA 141-225 that provides for use of OPTAFLEXX
(ractopamine hydrochloride) and RUMENSIN (monensin, USP) Type A
medicated articles to formulate two-way combination drug Type C
medicated feeds for cattle fed in confinement for slaughter. Elanco
Animal Health also filed a supplement to NADA 141-224 that provides for
use of OPTAFLEXX (ractopamine hydrochloride), RUMENSIN (monensin, USP),
and TYLAN (tylosin phosphate) Type A medicated articles to formulate
three-way combination drug Type C medicated feeds for cattle fed in
confinement for slaughter.
    The supplemental NADAs provide for administering ractopamine
hydrochloride Type C medicated feeds as a top dress on Type C medicated
feeds containing monensin, USP, or monensin, USP, and tylosin phosphate
to cattle fed in confinement for slaughter as the means by which the
two-way or three-way combinations will be created. Supplemental NADA
141-224 is approved as of June 7, 2010; supplemental NADA 141-225 is
approved as of June 17, 2010; and the regulations in 21 CFR 558.500 are
amended to reflect the approvals.
    In accordance with the freedom of information provisions of 21 CFR
part 20 and 21 CFR 514.11(e)(2)(ii), a summaries of safety and
effectiveness data and information submitted to support approval of
these applications may be seen in the Division of Dockets Management
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday.
    The agency has determined under 21 CFR 25.33 that these actions are
of a type that do not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.
    This rule does not meet the definition of ``rule'' in 5 U.S.C.
804(3)(A) because it is a rule of ``particular applicability.''
Therefore, it is not subject to the congressional review requirements
in 5 U.S.C. 801-808.

List of Subjects in 21 CFR Part 558

    Animal drugs, Animal feeds.

0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under the
authority delegated to the Commissioner of Food and Drugs and
redelegated to the Center for Veterinary Medicine, 21 CFR part 558 is
amended as follows:

PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

    1. The authority citation for 21 CFR part 558 continues to read as
follows:

    Authority: 21 U.S.C. 360b, 371.

0
2. In Sec.  558.500, add paragraphs (e)(2)(xii) and (e)(2)(xiii) to
read as follows:

Sec.  558.500  Ractopamine.

* * * * *
    (e) * * *
    (2) * * *

----------------------------------------------------------------------------------------------------------------
                                  Combination in
   Ractopamine in  grams/ton         grams/ton       Indications for use          Limitations          Sponsor
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
(xii) Not to exceed 800; to      Monensin 10 to    Cattle fed in            Top dress ractopamine         000986
 provide 70 to 400 mg/head/day.   40 to provide     confinement for          in a minimum of 1.0 lb
                                  0.14 to 0.42 mg   slaughter: As in         of medicated feed
                                  monensin/lb of    paragraph (e)(2)(i) of   during the last 28 to
                                  body weight,      this section; for        42 days on feed. Not
                                  depending on      prevention and control   for animals intended
                                  severity of       of coccidiosis due to    for breeding. See Sec.
                                  coccidiosis       Eimeria bovis and E.       558.355(d).
                                  challenge, up     zuernii.
                                  to 480 mg/head/
                                  day.
----------------------------------------------------------------------------------------------------------------

(xiii) Not to exceed 800; to     Monensin 10 to    Cattle fed in            Top dress ractopamine         000986
 provide 70 to 400 mg/head/day.   40 to provide     confinement for          in a minimum of 1.0 lb
                                  0.14 to 0.42 mg   slaughter: As in         of medicated feed
                                  monensin/lb of    paragraph (e)(2)(i) of   during the last 28 to
                                  body weight,      this section; for        42 days on feed. Not
                                  depending on      prevention and control   for animals intended
                                  severity of       of coccidiosis due to    for breeding. See Sec.
                                  coccidiosis       Eimeria bovis and E.      Sec.   558.355(d) and
                                  challenge, up     zuernii; and for         558.625(c).
                                  to 480 mg/head/   reduction of incidence
                                  day, plus         of liver abscesses
                                  tylosin 8 to      caused by
                                  10.               Fusobacterium
                                                    necrophorum and
                                                    Arcanobacterium
                                                    (Actinomyces)
                                                    pyogenes.
----------------------------------------------------------------------------------------------------------------

* * * * *

    Dated: August 31, 2010.
Elizabeth Rettie,
Deputy Director, Office of New Animal Drug Evaluation, Center for
Veterinary Medicine.
[FR Doc. 2010-22071 Filed 9-2-10; 8:45 am]
BILLING CODE 4160-01-S


[Federal Register: September 11, 2009 (Volume 74, Number 175)]
[Notices]
[Page 46758]
[DOCID:fr11se09-35]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP09-459-000]

Egan Hub Storage, LLC; Notice of Request Under Blanket
Authorization

September 3, 2009.
    Take notice that on August 31, 2009, Egan Hub Storage, LLC (Egan
Hub), filed in Docket No. CP09-459-000, a prior notice request pursuant
to Sections 157.205, 157.208, 157.211, 157.212 and 157.213 of the
Commission's regulations under the Natural Gas Act (NGA), for
authorization to construct and operate facilities to connect the Egan
Hub system to Kinder Morgan Louisiana Pipeline LLC (KMLP) in Acadia
Parish, Louisiana in order to receive and deliver natural gas from and
to KMLP, all as more fully set forth in the application which is on
file with the Commission and open to public inspection. Egan Hub
proposes to perform these activities under its blanket certificate
issued October 7, 1996, in Docket No. CP96-199-000 [77 FERC ] 61,016
(1996)].
    The filing may be viewed on the Web at http://www.ferc.gov using
the ``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field to access the document. For
assistance, contact FERC at<EMAIL_ADDRESS>or call toll-
free,<PHONE_NUMBER> or TYY,<PHONE_NUMBER>.
    Specifically, Egan Hub seeks authorization to construct, own,
operate, and maintain a new pipeline tap on its Fourth Cavern Line 85,
and associated connecting piping to the edge of the right-of-way, to
receive and deliver natural gas at an interconnection with KMLP's
interstate pipeline facilities, at a site selected by KMLP.
Additionally, Egan Hub will own, operate and maintain a check
electronic gas measurement (EGM) facility that KMLP will install at its
meter and regulator (M&R) site. KMLP's facilities are designed
primarily to receive revaporized liquefied natural gas (LNG) from the
Sabine Pass LNG, L.P. LNG import terminal to be located in Cameron
Parish, Louisiana.
    Egan Hub also proposes the design and construction of approximately
15 feet of 16-inch diameter pipe, a single 24-inch by 24-inch by 16-
inch tee tap and a 16-inch valve. The check EGM, to be constructed by
KMLP within its M&R site, is to be owned and operated by Egan Hub. The
project area is located within the corridor of Egan Hub's Fourth Cavern
Project Line 85 at approximately milepost 6.9 in Acadia Parish,
Louisiana. With the exception of the check EGM, the project area is
entirely within the proposed workspace previously surveyed and approved
for Egan Hub's Fourth Cavern Project. Egan Hub has estimated the total
cost of constructing the facilities proposed herein to be $400,000.
Egan Hub will bear all costs associated with constructing such
facilities. The proposed in-service date for the interconnect
facilities is March 1, 2010.
    Any questions regarding this application may be directed to Lisa A.
Moore, General manager, Rates and Certificates, Egan Hub Storage, LLC,
P. O. Box 1642, Houston, Texas 77251-1642; phone<PHONE_NUMBER>, FAX
(713)627-5947.
    Any person or the Commission's Staff may, within 60 days after the
issuance of the instant notice by the Commission, file pursuant to Rule
214 of the Commission's Procedural Rules (18 CFR 385.214) a motion to
intervene or notice of intervention and, pursuant to section 157.205 of
the Commission's Regulations under the NGA (18 CFR 157.205) a protest
to the request. If no protest is filed within the time allowed
therefore, the proposed activity shall be deemed to be authorized
effective the day after the time allowed for protest. If a protest is
filed and not withdrawn within 30 days after the time allowed for
filing a protest, the instant request shall be treated as an
application for authorization pursuant to Section 7 of the NGA.
    The Commission strongly encourages electronic filings of comments,
protests, and interventions via the Internet in lieu of paper. See 18
CFR 385.2001(a) (1) (iii) and the instructions on the Commission's Web
site (http://www.ferc.gov) under the ``e-Filing'' link. Persons unable
to file electronically should submit an original and 14 copies of the
protest or intervention to the Federal Energy regulatory Commission,
888 First Street, NE., Washington, DC 20426.

Kimberly D. Bose,
Secretary.
[FR Doc. E9-21866 Filed 9-10-09; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 76, Number 166 (Friday, August 26, 2011)]
[Notices]
[Page 53437]
[FR Doc No: 2011-21785]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 12849-003; Project No. 14095-000]

Free Flow Power Corporation; Northland Power Mississippi River
LLC; Notice of Competing Preliminary Permit Applications Accepted for
Filing and Soliciting Comments, Motions To Intervene, and Competing
Applications

August 18, 2011.
    On January 11, 2011, Free Flow Power Corporation (Free Flow) and
Northland Power Mississippi River LLC (Northland) filed preliminary
permit applications, pursuant to section 4(f) of the Federal Power Act,
proposing to study the feasibility of developing hydropower projects
hydropower on the Mississippi River, near the town of Point a La Hache,
in Plaquemines Parish, Louisiana. The sole purpose of a preliminary
permit, if issued, is to grant the permit holder priority to file a
license application during the permit term. A preliminary permit does
not authorize the permit holder to perform any land-disturbing
activities or otherwise enter upon lands or waters owned by others
without the owners' express permission.
    The proposed projects are described as follows:

    Free Flow's hydrokinetic Project, Project No. 12849-003 would
consist of: (1) Up to 900 SmartTurbine generating units installed in
arrays on the bottom of the river; (2) the total capacity of the
installation would be up to 36,000 kilowatts; (3) flexible cables
would convey each arrays power to a metering station; and (4) a
transmission line would interconnect with the power grid. The
proposed project would have an average annual generation of
81,872,100 kilowatt-hours (kWh), which would be sold to a local
utility.
    Northland's hydrokinetic Project, Project No. 14095-000 would
consist of: (1) Up to 140 TREK generating units installed in a
matrix on the bottom of the river; (2) the total capacity of the
installation would be up to 35,000 kilowatts; (3) shielded
underwater cables would convey each matrix power to a substation;
and (4) a transmission line would interconnect with the power grid.
The proposed project would have an average annual generation of
307,000,000 kWh, which would be sold to a local utility.
    Applicants Contact: For Free Flow: Ramya Swaminathan, Free Flow
Power Corporation, 239 Causeway Street, Boston, MA 02114; phone
(978) 283-2822. For Northland: Tim Richardson, 30 St. Clair Avenue
West 17th Floor, Toronto, Ontario, Canada; phone<PHONE_NUMBER>.
    FERC Contact: Michael Spencer,<PHONE_NUMBER>.

    Deadline for filing comments, motions to intervene, competing
applications (without notices of intent), or notices of intent to file
competing applications: 60 days from the issuance of this notice.
Competing applications and notices of intent must meet the requirements
of 18 CFR 4.36. Comments, motions to intervene, notices of intent, and
competing applications may be filed electronically via the Internet.
See 18 CFR 385.2001(a)(1)(iii) and the instructions on the Commission's
Web site (http://www.ferc.gov/docs-filing/ferconline.asp) under the
``eFiling'' link. For a simpler method of submitting text-only
comments, click on ``Quick Comment.'' For assistance, please contact
FERC Online Support at<EMAIL_ADDRESS>call toll-free at
(866) 208-3676; or, for TTY, contact<PHONE_NUMBER>. Although the
Commission strongly encourages electronic filing, documents may also be
paper-filed. To paper-file, mail an original and eight copies to:
Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission, 888
First Street, NE., Washington, DC 20426.
    More information about this project, including a copy of the
application, can be viewed or printed on the ``eLibrary'' link of the
Commission's Web site at http://www.ferc.gov/docs-filing/elibrary.asp.
Enter the docket number (P-12849-003, or P-14095-000) in the docket
number field to access the document. For assistance, contact FERC
Online Support.

    Dated: August 18, 2011.
Kimberly D. Bose,
Secretary.
[FR Doc. 2011-21785 Filed 8-25-11; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 78, Number 216 (Thursday, November 7, 2013)]
[Notices]
[Pages 66941-66942]
[FR Doc No: 2013-26690]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0567]

Design Considerations for Pivotal Clinical Investigations for
Medical Devices; Guidance for Industry, Clinical Investigators,
Institutional Review Boards and Food and Drug Administration Staff;
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the guidance entitled ``Design Considerations for
Pivotal Clinical Investigations for Medical Devices.'' This document is
intended to provide guidance to those involved in designing clinical
studies intended to support premarket submissions for medical devices
and for FDA staff who review those submissions. This guidance document
describes different study design principles relevant to the development
of medical device clinical studies that can be used to fulfill
premarket clinical data requirements.

DATES: Submit either electronic or written comments on this guidance at
any time. General comments on agency guidance documents are welcome at
any time.

ADDRESSES: Submit written requests for single copies of the guidance
document entitled ``Design Considerations for Pivotal Clinical
Investigations for Medical Devices'' to the Division of Small
Manufacturers, International, and Consumer Assistance, Center for
Devices and Radiological Health (CDRH), Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 66, rm. 4613, Silver Spring, MD 20993-
0002; or the Office of Communication, Outreach and Development (HFM-
40), Center for Biologics Evaluation and Research (CBER), Food and Drug
Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-
1448. Send one self-addressed adhesive label to assist that office in
processing your request, or fax your request to CDRH at<PHONE_NUMBER>.
See the SUPPLEMENTARY INFORMATION section for information on electronic
access to the guidance.

    Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852. Identify comments with the docket number
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT:
    For devices regulated by CDRH: Gregory Campbell, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, rm. 2110, Silver Spring, MD 20993-0002, 301-
796-5750.
    For devices regulated by CBER: Stephen Ripley, Center for Biologics
Evaluation and Research (HFM-17), Food and Drug Administration, 1401
Rockville Pike, suite 200N, Rockville, MD 20852-1448,<PHONE_NUMBER>.

I. Background

    The guidance document is intended to provide guidance to those
involved in designing clinical studies that support premarket
submissions for medical devices and FDA staff who review those
submissions. Although the Agency has articulated policies related to
design of studies intended to support specific device types, and a
general policy of tailoring the evidentiary burden to the regulatory
requirement, the Agency has not attempted to describe the different
clinical study designs that may be appropriate to support a device
premarket submission, or to define how a sponsor should decide which
pivotal clinical study design should be used to support a submission
for a particular device. The guidance document describes different
study design principles relevant to the development of medical device
clinical studies that can be used to fulfill premarket clinical data
requirements. The guidance is not intended to provide a comprehensive
tutorial on the best clinical and statistical practices for
investigational medical device studies.
    A medical device pivotal study is a definitive study in which
evidence is gathered to support the safety and effectiveness evaluation
of the medical device for its intended use. Evidence from one or more
pivotal clinical studies generally serves as the primary basis for the
determination of reasonable assurance of safety and effectiveness of
the medical device of a premarket approval application (PMA) and FDA's
overall risk-benefit assessment. In some cases, a PMA may include
multiple studies designed to answer different scientific questions.
    The guidance describes principles that should be followed for the
design of premarket clinical studies that are pivotal in establishing
the safety and effectiveness of a medical device. Practical issues and
pitfalls in pivotal clinical study design are discussed, along with
their effects on the conclusions that can be drawn from the studies
concerning safety and effectiveness.
    In the Federal Register of August 15, 2011 (76 FR 50484), FDA
announced the availability of the draft guidance. Interested persons
were invited to comment by November 14, 2011. FDA considered the
comments and revised the guidance, as appropriate.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
Agency's current thinking on pivotal clinical investigations for
medical devices. It does not create or confer any rights for or on any
person and does not operate to bind FDA or the public. An alternative
approach may be used if such approach satisfies the requirements of the
applicable statute and regulations.

III. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so by
using the Internet. A search capability for all CDRH guidance documents
is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance
documents are also available at http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm or http://www.regulations.gov. To receive ``Device
Considerations for Pivotal Clinical Investigations for Medical
Devices,'' you may either send an email request to<EMAIL_ADDRESS>to receive an electronic copy of the document or send a fax request to
301-847-8149 to receive a hard copy. Please use the document number
1776 to identify the guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR part 807, subpart E have been
approved under 0910-0120; the collections of information in 21 CFR part
812 have been approved under 0910-0078; the collections of information
in 21 CFR part 814 have been approved under 0910-0231.

V. Comments

    Interested persons may submit either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). 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. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

    Dated: November 1, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-26690 Filed 11-6-13; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 81, Number 212 (Wednesday, November 2, 2016)]
[Notices]
[Pages 76412-76414]
[FR Doc No: 2016-26384]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[Docket No. NHTSA-2016-0067; Notice 2]

Michelin North America, Inc., Grant of Petition for Decision of
Inconsequential Noncompliance

AGENCY: National Highway Traffic Safety Administration (NHTSA),
Department of Transportation (DOT).

ACTION: Grant of petition.

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SUMMARY: Michelin North America, Inc. (MNA), has determined that
certain MNA tires do not fully comply with paragraph S5.5.1(b) of
Federal Motor Vehicle Safety Standard (FMVSS) No. 139, New pneumatic
radial tires for light vehicles. MNA filed a report dated May 5, 2016,
pursuant to 49 CFR part 573, Defect and Noncompliance Responsibility
and Reports. MNA then petitioned NHTSA under 49 CFR part 556 requesting
a decision that the subject noncompliance is

inconsequential as it relates to motor vehicle safety.

ADDRESSES: For further information on this decision contact Abraham
Diaz, Office of Vehicle Safety Compliance, the National Highway Traffic
Safety Administration (NHTSA), telephone<PHONE_NUMBER>, facsimile
(202) 366-5930.

SUPPLEMENTARY INFORMATION:

I. Overview

    Pursuant to 49 U.S.C. 30118(d) and 30120(h) (see implementing rule
at 49 CFR part 556), MNA submitted a petition for an exemption from the
notification and remedy requirements of 49 U.S.C. Chapter 301 on the
basis that this noncompliance is inconsequential as it relates to motor
vehicle safety.
    Notice of receipt of the petition was published, with a 30-day
public comment period on August 3, 2016 in the Federal Register (81 FR
51266). No comments were received. To view the petition and all
supporting documents log onto the Federal Docket Management System
(FDMS) Web page at: http://www.regulations.gov/. Then follow the online
search instruction to locate docket number ``NHTSA-2016-0067.''

II. Tires Involved

    Affected are approximately 186 MNA Uniroyal Tiger Paw AWP II size
P215/70R15 97T passenger car tires that were manufactured between
January 10, 2016 and January 13, 2016.

III. Noncompliance

    MNA explains that two of the digits in the tire identification
number (TIN) that identify the week and year of manufacture were
inadvertently switched. This resulted in the tires, which were
manufactured in the second week of 2016, being molded with a
manufacturing date of ``0126'' rather than the correct marking of
``0216,'' contrary to the requirements specified in paragraph S5.5.1 of
FMVSS No. 139 and 49 CFR 574.5(g)(4).

IV. Rule Text

    Paragraph S5.5.1 of FMVSS No. 139 requires in pertinent part:

    S5.5.1 Tire Identification Number.
    . . .
    (b) Tires manufactured on or after September 1, 2009. Each tire
must be labeled with the tire identification number required by 49
CFR part 574 on the intended outboard sidewall of the tire.

    49 CFR 574.5(g)(4) provides that the fourth grouping of symbols
within the tire identification number shall ``identify the week and
year of manufacture.'' The regulation specifies that ``[t]he first and
second symbols of the date code must identify the week of the year,''
and ``[t]he third and fourth symbols of the date code identify the last
two digits of the year of manufacture.'' Applying these requirements,
the subject tires, which were manufactured during week 2 of 2016,
should display ``0216'' as the date code, but instead display ``0126''
as the date code.

V. Summary of MNA's Petition

    MNA believes that this noncompliance is inconsequential as it
relates to motor vehicle safety.
    In support of its petition, MNA submitted the following information
and analysis of the subject noncompliance:
    1. MNA stated that although the date code is not correct, it
specifies a date well into the future and thus offers a unique
identification for the subject tires. Furthermore, the incorrect but
unique coding has been recorded in MNA's records and can be used to
identify the subject tires in the event of a future market action.
    2. MNA also stated that there should be no risk of duplication of
the TIN in the future since the current 2 digit plant code will be
replaced with a 3 digit plant code by April 25, 2025, thus creating a
new TIN sequence prior to week 1 of 2026 (the date inadvertently
specified on the subject tires).
    3. MNA further noted that the incorrect date code does not
compromise the ability to register the tire. Tire registration cards
accept the date as marked (0126). Moreover, the Uniroyal tire
registration Web page accepts the TIN with the date as described.
    4. MNA also stated that Michelin's consumer care team has been
informed should there be any questions from a consumer or dealer.
    5. MNA concluded by noting that all other markings on the subject
tires conform to the applicable regulations and meet all performance
requirements of FMVSS No. 139.
    In its part 573 Report, MNA stated that there is no imminent safety
risk associated with the mismarking.
    In summation, MNA believes that the described noncompliance is
inconsequential as it relates to motor vehicle safety, and that its
petition, to exempt MNA from providing notification of the
noncompliance, as required by 49 U.S.C. 30118, and a remedy for the
noncompliance, as required by 49 U.S.C. 30120, should be granted.

NHTSA's Decision

    NHTSA's Analysis: The agency believes that in the case of a tire
labeling noncompliance, one measure of its inconsequentiality to motor
vehicle safety is whether the mislabeling would affect the
manufacturer's or consumer's ability to identify the mislabeled tires
properly, should the tires be recalled for performance related
noncompliance.
    After review of MNA's petition, NHTSA believes that the mislabeling
of the date code would not create confusion with manufacturers or
consumers should there be a recall since MNA has taken the following
measures that would enable correct tire registration: (1) Accepting
registration cards for tires that have an incorrectly labeled date
code, (2) accepting internet registration through their Web page for
tires that have an incorrectly labeled date code, and (3) informing
their consumer care team about how to address the mislabeling in
response to customers' inquiries.
    NHTSA's Decision: In consideration of the foregoing, NHTSA finds
that MNA has met its burden of persuasion that the subject FMVSS No.
139 noncompliance in the affected tires is inconsequential to motor
vehicle safety. Accordingly, MNA's petition is hereby granted and MNA
is consequently exempted from the obligation of providing notification
of, and a free remedy for, that noncompliance under 49 U.S.C. 30118 and
30120.
    NHTSA notes that the statutory provisions (49 U.S.C. 30118(d) and
30120(h)) that permit manufacturers to file petitions for a
determination of inconsequentiality allow NHTSA to exempt manufacturers
only from the duties found in sections 30118 and 30120, respectively,
to notify owners, purchasers, and dealers of a defect or noncompliance
and to remedy the defect or noncompliance. Therefore, this decision on
this petition only applies to the subject tires that MNA no longer
controlled at the time it determined that the noncompliance existed.
However, the granting of this petition does not relieve equipment
distributors and dealers of the prohibitions on the sale, offer for
sale, or introduction or delivery for introduction into interstate
commerce of the noncompliant tires under their control after MNA
notified them that the subject noncompliance existed.

    Authority: (49 U.S.C. 30118, 30120: Delegations of authority at
49 CFR 1.95 and 501.8).

Jeffrey M. Giuseppe,
Director, Office of Vehicle Safety Compliance.
[FR Doc. 2016-26384 Filed 11-1-16; 8:45 am]
 BILLING CODE 4910-59-P


[Federal Register Volume 87, Number 107 (Friday, June 3, 2022)]
[Notices]
[Page 33805]
[FR Doc No: 2022-11908]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4505-DR; Docket ID FEMA-2022-0001]

Rhode Island; Amendment No. 9 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice amends the notice of a major disaster declaration
for the State of Rhode Island (FEMA-4505-DR), dated March 30, 2020, and
related determinations.

DATES: This change occurred on May 17, 2022.

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: The Federal Emergency Management Agency
(FEMA) hereby gives notice that pursuant to the authority vested in the
Administrator, under Executive Order 12148, as amended, Lori A.
Ehrlich, of FEMA is appointed to act as the Federal Coordinating
Officer for this disaster.
    This action terminates the appointment of Paul F. Ford as Federal
Coordinating Officer for this disaster.

    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.

Deanne Criswell,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2022-11908 Filed 6-2-22; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register Volume 87, Number 225 (Wednesday, November 23, 2022)]
[Notices]
[Pages 71632-71633]
[FR Doc No: 2022-25605]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-R02-OAR-2022-0715; FRL-10145-01-R2]

Adequacy Status of Motor Vehicle Emissions Budgets for the New
York Portion of the New York-Northern New Jersey-Long Island, NY-NJ-CT
2008 8-Hour Ozone Nonattainment Area

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of adequacy.

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

SUMMARY: In this notice, the EPA is notifying the public that it has
found that the 2020 motor vehicle emissions budgets for volatile
organic compounds (VOCs) and nitrogen oxides (NOX),
submitted by the New York State Department of Environmental

Conservation on November 29, 2021, for the 2008 national ambient air
quality standard (NAAQS) for ozone (the Budgets), are adequate for
transportation conformity purposes for the New York portion of the New
York-Northern New Jersey-Long Island, NY-NJ-CT 8-hour ozone
nonattainment area. This revision to the SIP included 2020 summer day
VOC and NOX Budgets associated with the SIP's reasonable
further progress demonstration.

DATES: This finding is effective December 8, 2022.

ADDRESSES: Publicly available docket materials, identified by Docket ID
Number EPA-R02-OAR-2022-0715, are available either electronically
through www.regulations.gov or in hard copy at the EPA Docket Center,
WJC West Building, Room 3334, 1301 Constitution Ave. NW, Washington,
DC. The Docket Center's hours of operations are 8:30 a.m.-4:30 p.m.,
Monday-Friday (except Federal holidays). For further information on the
EPA Docket Center services and the current status, see: https://www.epa.gov/dockets. You may access this Federal Register document
electronically from https://www.federalregister.gov/documents/current.
This finding will also be available at the EPA's conformity website:
https://www.epa.gov/state-and-local-transportation/state-implementation-plans-sip-submissions-currently-under-epa#newyork-ny-nj-ct.

FOR FURTHER INFORMATION CONTACT: Lily Black, Environmental Protection
Agency Region 2, Air and Radiation Division, 290 Broadway, 25th Floor,
New York, New York 10007-1866;<PHONE_NUMBER>, [email protected].

SUPPLEMENTARY INFORMATION: Throughout this document, whenever ``we,''
``us,'' or ``our'' is used, we mean the EPA.
    Today's notice is an announcement of a finding that we have already
made. EPA Region 2 sent a letter to the New York Department of
Environmental Conservation on July 26, 2022, stating that the 2020
motor vehicle emissions budgets (``Budgets'') are adequate for
transportation conformity purposes.
    The transportation conformity rule requires that the EPA conduct a
public process and make an affirmative decision on the adequacy of
these budgets before they can be used by metropolitan planning
organizations in transportation conformity determinations.
    As a result of this finding, upon the effective date of this notice
of adequacy, the New York Metropolitan Transportation Council (NYMTC)
must use the Budgets in future transportation conformity
determinations. The Budgets are associated with the reasonable further
progress milestone demonstration.
    We announced availability of the plan and related Budgets on the
EPA's transportation conformity website on March 8, 2022, requesting
comments by April 8, 2022. We received no comments in response to the
adequacy review posting.
    The Budgets are provided in Table 1.

           Table 1--Motor Vehicle Emissions Budgets for NYMTC
                             [tons per day]
------------------------------------------------------------------------
                          Year                             NOX      VOC
------------------------------------------------------------------------
2020...................................................    89.07   54.51
------------------------------------------------------------------------

    Transportation conformity is required by Clean Air Act section
176(c), 42 U.S.C. 7506(c). The EPA's conformity rule requires that
long-range transportation plans, transportation improvement programs,
and transportation projects conform to a state's air quality SIP and
establishes the criteria and procedures for determining whether or not
they conform. Conformity to a SIP means that transportation activities
will not produce new air quality violations, worsen existing
violations, or delay timely attainment of the NAAQS. See id. at section
7506(c)(1)(B).
    The criteria the EPA uses to determine whether a SIP's motor
vehicle emission budgets are adequate for conformity purposes are
outlined in 40 CFR 93.118(e)(4).\1\ And we have described our process
for determining the adequacy of submitted SIP budgets in 40 CFR
93.118(f). Under 40 CFR 93.104(e), within 2 years of the effective date
of this notice, NYMTC and the U.S. Department of Transportation will
need to demonstrate conformity to the Budgets. To do so, the on-road
motor vehicle emissions from implementation of the long-range
transportation plan should be projected consistently with the Budgets.
---------------------------------------------------------------------------

    \1\ An adequacy review is separate from the EPA's completeness
review and should not be used to prejudge the EPA's ultimate action
on the SIP. Even if we find a budget adequate, the SIP could later
be disapproved.
---------------------------------------------------------------------------

    Authority: 42 U.S.C. 7401-7671q.

Lisa Garcia,
Regional Administrator, Region 2.
[FR Doc. 2022-25605 Filed 11-22-22; 8:45 am]
BILLING CODE 6560-50-P


\185\ The Commission notes that controlled companies are
provided an automatic exemption from the application of the entirety
of Rule 10C-1 by Rule 10C-1(b)(5).
---------------------------------------------------------------------------

    The NYSE MKT proposal would continue to permit foreign private
issuers to follow home country practice in lieu of the provisions of
the new rules, without requiring any further disclosure from such
entities. The Commission believes that granting exemptions to foreign
private issuers in deference to their home country practices with
respect to compensation committee practices is appropriate, and
believes that the existing disclosure requirements will help investors
determine whether they are satisfied with the alternative standard. The
Commission notes that such entities are exempt from the compensation
committee independence requirements of Rule 10C-1 to the extent such
entities disclose in their annual reports the reasons they do not have
independent compensation committees.

F. Transition to the New Rules for Companies Listed as of the Effective
Date

    The Commission believes that the deadlines for compliance with the
proposal's various provisions are reasonable and should afford listed
companies adequate time to make the changes, if any, necessary to meet
the new standards. The Commission believes that the deadline proposed
is clear-cut and matches the deadline set forth by NYSE and The NASDAQ
Stock Market, as revised.\186\ Accordingly, the deadline gives
companies until the earlier of their first annual meeting after January
15, 2014, or October 31, 2014, to comply with the remaining
provisions.\187\
---------------------------------------------------------------------------

    \186\ See Securities Exchange Act Release Nos. 68011 (October 9,
2012), 77 FR 62541 (October 15, 2012) (Notice of File No. SR-NYSE-
2012-49); 68013 (October 9, 2012), 77 FR 62563 (October 15, 2012)
(Notice of File No. SR-NASDAQ-2012-109); see also Amendment No. 1 to
File No. SR-NASDAQ-2012-109.
    \187\ The proposal is, however, otherwise effective on July 1,
2013, and issuers will be required to comply with the new
compensation committee charter and adviser requirements as of that
date. As noted above, certain existing issuers, such as smaller
reporting companies, are exempt from compliance with the new
independence requirement with respect to compensation committee
service.
---------------------------------------------------------------------------

G. Compliance Schedules: IPOs; Companies That Lose Their Exemptions;
Companies Transferring From Other Markets

    The Commission believes that it is reasonable for NYSE MKT to
allow, with respect to IPOs, companies emerging from bankruptcy,
companies ceasing to be controlled companies, companies ceasing to
qualify as a foreign private issuer, and companies transferring from
other markets, the same phase-in schedule for compliance with the new
requirements as is permitted under its current compensation-related
rules.
    The Commission also believes that the compliance schedule for
companies that cease to be Smaller Reporting Companies, as revised in
Amendment No. 3, affords such companies ample time to come into
compliance with the full panoply of rules that apply to other
companies. In the Commission's view, the revised schedule also offers
such companies more clarity in determining

when they will be subject to the heightened requirements.

V. Accelerated Approval of Amendment No. 3 to the Proposed Rule Change

    The Commission finds good cause, pursuant to Section 19(b)(2) of
the Act,\188\ for approving the proposed rule change, as modified by
Amendment Nos. 1 and 3, prior to the 30th day after the date of
publication of notice in the Federal Register.
---------------------------------------------------------------------------

    \188\ 15 U.S.C. 78s(b)(2).
---------------------------------------------------------------------------

    The change made to the proposal by Amendment No. 3 to change a
reference from Item 10(f)(1) of Regulation S-K to a reference to
Exchange Act Rule 12b-2 is not a substantive one and merely references
an otherwise identical definition.
    The revision made by Amendment No. 3 to the compliance rules for
companies that cease to be Smaller Reporting Companies \189\
establishes a schedule that is easier to understand, while still
affording such companies adequate time to come into compliance with the
applicable requirements. The Commission notes that the Start Date of
the compliance period for such a company is six months after the
Smaller Reporting Company Determination Date, and the company is given
no less than another six months from the Start Date to gain compliance
with the rules from which it had been previously exempt. As originally
proposed a Smaller Reporting Company had to comply within six months of
the Smaller Reporting Company Determination Date, and for the adviser
assessment at the Smaller Reporting Company Determination Date. The
Commission believes the amendments to the transitions for issuers that
lose their status as a Smaller Reporting Company will afford such
companies additional time to comply and avoid issues involving
inadvertent non-compliance because of the provision that originally
applied immediately on the Smaller Reporting Company Determination
Date. The amendments also provide additional clarity on when the time
frames commence, and as such the Commission believes good cause exists
to accelerate approval.
---------------------------------------------------------------------------

    \189\ See supra notes 76-78 and accompanying text.
---------------------------------------------------------------------------

    The change to commentary made by Amendment No. 3 to exclude
advisers that provide only certain types of services from the
independence assessment is also appropriate. As discussed above, the
Commission has already determined to exclude such advisers from the
disclosure requirement regarding compensation advisers in Regulation S-
K because these types of services do not raise conflict of interest
concerns. Finally, the addition of further guidance by Amendment No. 3
merely clarifies that nothing in the Exchange's rules requires a
compensation adviser to be independent, only that the Compensation
Committee consider the independence factors before selecting or
receiving advice from a compensation adviser, and is not a substantive
change, as it was the intent of the rule as originally proposed.
    For all the reasons discussed above, the Commission finds good
cause to accelerate approval of the proposed changes made by Amendment
No. 3.

VI. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing and whether Amendment No. 3 is
consistent with the Act. Comments may be submitted by any of the
following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-NYSEMKT-2012-48 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NYSEMKT-2012-48. This
file number should be included on the subject line if email is used.
    To help the Commission process and review your comments more
efficiently, please use only one method. The Commission will post all
comments on the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments,
all written statements with respect to the proposed rule change that
are filed with the Commission, and all written communications relating
to the proposed rule change between the Commission and any person,
other than those that may be withheld from the public in accordance
with the provisions of 5 U.S.C. 552, will be available for Web site
viewing and printing in the Commission's Public Reference Room on
official business days between the hours of 10:00 a.m. and 3:00 p.m.
Copies of such filing also will be available for inspection and copying
at the principal office of NYSE. All comments received will be posted
without change; the Commission does not edit personal identifying
information from submissions. You should submit only information that
you wish to make available publicly. All submissions should refer to
File Number SR-NYSEMKT-2012-48, and should be submitted on or before
February 12, 2013.

VII. Conclusion

    In summary, and for the reasons discussed in more detail above, the
Commission believes that the rules being adopted by NYSE MKT, taken as
whole, should benefit investors by helping listed companies make
informed decisions regarding the amount and form of executive
compensation. NYSE MKT's new rules will help to meet Congress's intent
that compensation committees that are responsible for setting
compensation policy for executives of listed companies consist only of
independent directors.
    NYSE MKT's rules also, consistent with Rule 10C-1, require
Compensation Committees of listed companies to assess the independence
of compensation advisers, taking into consideration six specified
factors. This should help to assure that Compensation Committees of
NYSE MKT-listed companies are better informed about potential conflicts
when selecting and receiving advice from advisers. Similarly, the
provisions of NYSE MKT's standards that require Compensation Committees
to be given the authority to engage and oversee compensation advisers,
and require the listed company to provide for appropriate funding to
compensate such advisers, should help to support the compensation
committee's role to oversee executive compensation and help provide
Compensation Committees with the resources necessary to make better
informed compensation decisions.
    For the foregoing reasons, the Commission finds that the proposed
rule change, SR-NYSEMKT-2012-48, as modified by Amendment Nos. 1 and 3,
is consistent with the Act and the rules and regulations thereunder
applicable to a national securities exchange, and, in particular, with
Section 6(b)(5) of the Act.\190\
---------------------------------------------------------------------------

    \190\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\191\ that the

proposed rule change, SR-NYSEMKT-2012-48, as modified by Amendment Nos.
1 and 3, be, and it hereby is, approved.
---------------------------------------------------------------------------

    \191\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\192\
---------------------------------------------------------------------------

    \192\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2013-01104 Filed 1-18-13; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 82, Number 94 (Wednesday, May 17, 2017)]
[Notices]
[Pages 22713-22714]
[FR Doc No: 2017-09902]

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

Federal Aviation Administration

Approval of Noise Compatibility Program, Melbourne International
Airport, Melbourne, FL

AGENCY: Federal Aviation Administration, DOT.

ACTION: Notice.

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SUMMARY: The Federal Aviation Administration (FAA) announces its
findings on the Noise Compatibility Program submitted by the Melbourne
Airport Authority (MAA) under the Aviation Safety and Noise Abatement
Act, hereinafter referred to as ``the Act.'' These findings are made in
recognition of the description of Federal and nonfederal
responsibilities in Senate Report No. 96-52 (1980). On December 12,
2016, the FAA determined that the noise exposure maps submitted by the
MAA under Part 150 were in compliance with applicable requirements. On
April 25, 2017, the FAA approved the Melbourne International Airport
(MLB) noise compatibility program. All of the recommendations of the
program were approved. No program elements relating to new or revised
flight procedures for noise abatement were proposed by the airport
operator.

DATES: The effective date of the FAA's approval of the MLB Noise
Compatibility Program is April 25, 2017.

FOR FURTHER INFORMATION CONTACT: Allan Nagy, Federal Aviation
Administration, Orlando Airports District Office, 5950 Hazeltine
National Drive, Suite 400, Orlando, FL 32822, phone number: (407) 812-
6331. Documents reflecting this FAA action may be reviewed at this same
location.

SUPPLEMENTARY INFORMATION: This notice announces that the FAA has given
its overall approval to the Noise Compatibility Program for MLB,
effective April 25, 2017.
    Under Section 47504 of the Act, an airport operator who has
previously submitted a Noise Exposure Map may submit to the FAA a Noise
Compatibility Program which sets forth the measures taken or proposed
by the airport operator for the reduction of existing non-compatible
land uses and prevention of additional non-compatible land uses within
the area covered by the Noise Exposure Maps. The Act requires such
programs to be developed in consultation with interested and affected
parties including local communities, government agencies, airport
users, and FAA personnel.
    Each airport noise compatibility program developed in accordance
with Title 14 Code of Federal Regulations (CFR) part 150 is a local
program, not a Federal Program. The FAA does not substitute its
judgment for that of the airport operator with respect to which measure
should be recommended for action. The FAA's approval or disapproval of
14 CFR part 150 program recommendations is measured according to the
standards expressed in 14 CFR part 150 and the Act, and is limited to
the following determinations:
    a. The Noise Compatibility Program was developed in accordance with
the provisions and procedures of 14 CFR part 150;
    b. Program measures are reasonably consistent with achieving the
goals of reducing existing non-compatible land uses around the airport
and preventing the introduction of additional non-compatible land uses;
    c. Program measures would not create an undue burden on interstate
or foreign commerce, unjustly discriminate against types or classes of
aeronautical uses, violate the terms of airport grant agreements, or
intrude into areas preempted by the Federal government; and
    d. Program measures relating to the use of flight procedures can be
implemented within the period covered by the program without derogating
safety, adversely affecting the efficient use and management of the
navigable airspace and air traffic control systems, or adversely
affecting other powers and responsibilities of the Administrator
prescribed by law.
    Specific limitations with respect to FAA's approval of an airport
Noise Compatibility Program are delineated in 14 CFR part 150, Section
150.5. Approval is not a determination concerning the acceptability of
land uses under Federal, state, or local law. Approval does not by
itself constitute an FAA implementing action. A request for Federal
action or approval to implement specific noise compatibility measures
may be required, and an FAA decision on the request may require
environmental review of the proposed action. Approval does not
constitute a

commitment by the FAA to financially assist in the implementation of
the program nor a determination that all measures covered by the
program are eligible for grant-in-aid funding from the FAA. Where
Federal funding is sought, requests for project grants must be
submitted to the FAA Airports District Office in Orlando, FL.
    The MAA submitted to the FAA on September 9, 2016, the Noise
Exposure Maps, descriptions, and other documentation produced during
the noise compatibility planning Study conducted from October 2012
through September 9, 2016. The MLB Noise Exposure Maps were determined
by FAA to be in compliance with applicable requirements on December 1,
2016. Notice of this determination was published in the Federal
Register on December 12, 2016.
    The MLB Study contains a proposed Noise Compatibility Program
comprised of actions designed for phased implementation by airport
management and adjacent jurisdictions from the years 2016 to 2021. It
was requested that FAA evaluate and approve this material as a Noise
Compatibility Program as described in Section 47504 of the Act. The FAA
began its review of the Program on December 1, 2016, and was required
by a provisions of the Act to approve or disapprove the program within
180-days (other than the use of new or modified flight procedures for
noise control). Failure to approve or disapprove such program within
the 180-day period shall be deemed to be an approval of such program.
    The submitted program contained seven (7) proposed actions for
noise mitigation on the airport. The FAA completed its review and
determined that the procedural and substantive requirements of the Act
and 14 CFR part 150 have been satisfied. The overall program,
therefore, was approved by the FAA effective April 25, 2017.
    Outright approval was granted for the five (5) specific program
elements that require FAA Action. No FAA Action is required for the
remaining two (2) program elements which may be implemented by the MAA
outside of the Part 150 Process. The FAA Approved elements consist of:
Element AM-1, Noise Compatibility Program Management: This element
recommends the MAA Airport Manager manage the implementation of the
Noise Compatibility Program (NCP Section 12.1.1); Element AM-2,
Community Involvement: This element recommends that the MAA continues
accepting noise complaints via phone and email and that the MAA creates
a Web page on noise abatement that can be accessed from the main
Airport Web page (NCP Section 12.1.2); Element AM-3, Airport Noise
Abatement Signage: This element recommends that the MAA purchases and
installs noise abatement reminder signs at the ends of each runway to
raise pilot awareness of noise sensitive land uses in proximity to the
airport (NCP Section 12.1.3); Element AM-4, Develop a Jeppesen-style
Insert on Noise Abatement Programs at MLB: This element recommends that
the MAA voluntarily work with MLB ATCT, flight schools, and the FAA to
publish Jeppesen-style pilot handouts notifying pilots of the noise
abatement measures in place at MLB for better pilot awareness and
compliance with the NCP's recommended noise abatement measures (NCP
Section 12.1.4); Element AM-5, Noise Program Update: This element
recommends that MAA staff should continue to routinely examine
operating characteristics of MAA to determine if significant changes
have occurred that would require an update to the most recent FAA
approved Noise Exposure Maps (NCP Section 12.1.5).
    These determinations are set forth in detail in a Record of
Approval (ROA) signed by the FAA on April 25, 2017. The ROA, as well as
other evaluation materials and the documents comprising the submittal,
are available for review at the FAA office listed above and at the
administrative office of the Melbourne Airport Authority. The ROA will
also be available on-line at: http://www.faa.gov/airports_airtraffic/airports/environmental/airport_noise/part_150/states/.

    Issued in Orlando, FL, on May 8, 2017.
Rebecca R. Henry,
Acting Manager, Orlando Airports District Office.
[FR Doc. 2017-09902 Filed 5-16-17; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register: July 26, 2006 (Volume 71, Number 143)]
[Rules and Regulations]
[Page 42285-42288]
[DOCID:fr26jy06-14]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2006-0588; FRL-8078-4]

Oxirane, Methyl-, Polymer with Oxirane, Monobutyl Ether;
Tolerance Exemption

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of oxirane, methyl-, polymer with oxirane,
monobutyl ether; when used as an inert ingredient in a pesticide
chemical formulation. BASF Corporation, submitted a petition to EPA
under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by
the Food Quality Protection Act of 1996 (FQPA) requesting an exemption
from the requirement of a tolerance. This regulation eliminates the
need to establish a maximum permissible level for residues of oxirane,
methyl-, polymer with oxirane, monobutyl ether.

DATES: This regulation is effective July 26, 2006. Objections and
requests for hearings must be received on or before September 25, 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-2006-0588. 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
BusinessInformation (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 docketat http://www.regulations.gov, or, if

only availablein 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: Bipin Gandhi, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number:<PHONE_NUMBER>; e-mail<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 code 111)
     Animal production (NAICS code 112)
     Food manufacturing (NAICS code 311)
     Pesticide manufacturing (NAICS code 32532)
    This listing is not intended to be exhaustive, but rather 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 athttp://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
.

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-2006-0588 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 September 25, 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-2006-0588, 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., Mondaythrough 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 June 1, 2005 (70 FR 31453) (FRL-7711-2),
EPA issued a notice pursuant to section 408 of the FFDCA, 21 U.S.C.
346a, as amended by the FQPA (Public Law 104-170), announcing the
filing of a pesticide petition (PP 5E6917) by BASF Corporation, 100
Campus Drive, Florham Park, NJ 07932. The petition requested that 40CFR
180.960 be amended by establishing an exemption from the requirement of
a tolerance for residues of oxirane, methyl-, polymer with oxirane,
monobutyl ether; CAS Reg. No. 9038-95-3. That notice included a summary
of the petition prepared by the petitioner. There were no comments in
response to the notice of filing.
    Section 408(c)(2)(A)(i) of the FFDCA allows EPA to establish an
exemption from the requirement for 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(c)(2)(A)(ii) of the 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 forwhich 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 the FFDCA
requires EPA to give special consideration to exposure of infants and
children to the pesticide chemical residue in establishing an exemption
from the requirement of 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...'' and
specifies factors EPA is to consider in establishing an exemption.

III. Inert Ingredient Definition

    Inert ingredients are all ingredients that are not active
ingredients as defined in 40 CFR 153.125 and include, but are not
limited to, the following types of ingredients (except when they have a
pesticidal efficacy of their own): Solvents such as alcohols and
hydrocarbons; surfactants such as polyoxyethylene polymers and fatty
acids; carriers such as clay and diatomaceous earth; thickeners such as
carrageenan and modified cellulose; wetting, spreading, and dispersing
agents; propellants in aerosol dispensers; microencapsulating agents;
and emulsifiers. The term ``inert'' is not intended to imply
nontoxicity; the ingredient may or may not be chemicallyactive.
Generally, EPA has exempted inert ingredients from the requirement of a
tolerance based on the low toxicity of the individual inert
ingredients.

IV. Risk Assessment and Statutory Findings

    EPA establishes exemptions from the requirement of a tolerance only
in those cases where it can be shown that the risks from aggregate
exposure to pesticide chemical residues under reasonably foreseeable
circumstances will pose no appreciable risks to human health. In order
to determine the risks from aggregate exposure to pesticide inert
ingredients, the Agency considersthe toxicity of the inert in
conjunction with possible exposure to residues of the inert ingredient
through food, drinking water, and through other exposures that occur as
a result of pesticide use in residential settings. If EPA is able to
determine that a finite tolerance is not necessary to ensure that there
is a reasonable certainty that no harm will result from aggregate
exposure to the inert ingredient, an exemption from the requirement of
a tolerance may be established.
    Consistent with section 408(b)(2)(D) of the FFDCA, EPA has reviewed
the available scientific data and other relevant information in support
of this action and considered its validity, completeness and
reliability and the relationship of this information 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. In the case of certain chemical
substances that are defined as polymers, the Agency has established a
set of criteria to identify categories of polymers that should present
minimal or no risk. The definition of a polymer is given in 40 CFR
723.250(b). The following exclusion criteria for identifying these low
risk polymers are described in 40 CFR 723.250(d).
    1. The polymer, oxirane, methyl-, polymer with oxirane, monobutyl
ether, is not a cationic polymer nor is it reasonably anticipated to
become a cationic polymer in a natural aquatic environment.
    2. The polymer, oxirane, methyl-, polymer with oxirane, monobutyl
ether, does contain as an integral part of its composition the atomic
elements carbon, hydrogen, and oxygen.
    3. The polymer, oxirane, methyl-, polymer with oxirane, monobutyl
ether, does not contain as an integral part of its composition, except
as impurities, any element other than those listed in 40 CFR
723.250(d)(2)(ii).
    4. The polymer, oxirane, methyl-, polymer with oxirane, monobutyl
ether, is neither designed nor can it be reasonably anticipated to
substantially degrade, decompose, or depolymerize.
    5. The polymer, oxirane, methyl-, polymer with oxirane, monobutyl
ether, is manufactured or imported from monomers and/or reactants that
are already included on the TSCA Chemical Substance Inventory or
manufactured under an applicable TSCA section 5 exemption.
    6. The polymer, oxirane, methyl-, polymer with oxirane, monobutyl
ether, is not a water absorbing polymer with a number average molecular
weight (MW) greater than or equal to 10,000 daltons.
    Additionally, the polymer, oxirane, methyl-, polymer with oxirane,
monobutyl ether, also meets as required the following exemption
criteria specified in 40 CFR 723.250(e).
    7. The polymer's number average MW of 4,000 is greater than 1,000
and less than 10,000 daltons. The polymer contains less than 10%
oligomeric material below MW 500 and less than 25% oligomeric material
below MW 1,000, and the polymer does not contain any reactive
functional groups.
    Thus, oxirane, methyl-, polymer with oxirane, monobutyl ether meet
all the criteria for a polymer to be considered low risk under 40 CFR
723.250. Based on its conformance to the above criteria, no mammalian
toxicity is anticipated from dietary, inhalation, or dermal exposure to
oxirane, methyl-, polymer with oxirane, monobutyl ether.

V. Aggregate Exposures

    For the purposes of assessing potential exposure under this
exemption, EPA considered that oxirane, methyl-, polymer with oxirane,
monobutyl ether could be present in all

raw and processed agricultural commodities and drinking water, and that
non-occupational non-dietary exposure was possible. The number average
MW of oxirane, methyl-, polymer with oxirane, monobutyl ether is 4,000
daltons. Generally, a polymer of this size would be poorly absorbed
through the intact gastrointestinal tract or through intact human skin.
Since oxirane, methyl-, polymer with oxirane, monobutyl ether conform
to the criteria thatidentify a low risk polymer, there are no concerns
for risks associated with any potential exposure scenarios that are
reasonably foreseeable. The Agency has determined that a tolerance is
not necessary to protect the public health.

VI. Cumulative Effects

    Section 408 (b)(2)(D)(v) of FFDCA requires that, when considering
whether to establish, modify, or revoke a tolerance or tolerance
exemption, the Agency consider ``available information'' concerning the
cumulative effects of a particular chemical's residues and ``other
substances that have a common mechanism of toxicity.'' EPA does not
have, at this time, available data to determine whether oxirane,
methyl-, polymer with oxirane, monobutyl ether has a common mechanism
of toxicity with other substances. Unlike other pesticides for which
EPA has followed a cumulative risk approachbased on a common mechanism
of toxicity, EPA has not made a common mechanism of toxicity finding as
to oxirane, methyl-, polymer with oxirane, monobutyl ether and any
other substances and oxirane, methyl-, polymer with oxirane, monobutyl
ether 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 oxirane, methyl-, polymer with oxirane, monobutyl
ether 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 athttp://www.epa.gov/pesticides/cumulative
.

VII. Additional Safety Factor for the Protection of Infants and
Children

    Section 408 of the 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 data base unless EPA concludes
that a different margin of safety will be safe for infants and
children. Due to the expected low toxicity of oxirane, methyl-, polymer
with oxirane, monobutyl ether, EPA has not used a safety factor
analysis to assess the risk. For the same reasons the additional
tenfold safety factor is unnecessary.

VIII. Determination of Safety

    Based on the conformance to the criteria used to identify a low
risk polymer, EPA concludes that there is a reasonable certainty of no
harm to the U.S. population, including infants and children, from
aggregate exposure to residues of oxirane, methyl-, polymer with
oxirane, monobutyl ether.

IX. Other Considerations

A. Endocrine Disruptors

    There is no available evidence that oxirane, methyl-, polymer with
oxirane, monobutyl ether is an endocrine disruptor.

B. Analytical Enforcement Methodology

    An analytical method is not required for enforcement purposes since
the Agency is establishing an exemption from the requirement of a
tolerance without any numerical limitation.

C. International Tolerances

    The Agency is not aware of any country requiring a tolerance for
oxirane, methyl-, polymer with oxirane, monobutyl ether nor have any
CODEX Maximum Residue Levels (MRLs) been established for any food crops
at this time.

X. Conclusion

    Accordingly, EPA finds that exempting residues of oxirane, methyl-,
polymer with oxirane, monobutyl ether from the requirement of a
tolerance will be safe.

XI. Statutory and Executive Order Reviews

    This final rule establishes an exemption from the tolerance
requirement under section 408(d) of the 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 the FFDCA, such as the exemption 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. 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 foodretailers, 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 the 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 regulatorypolicies 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.

XII. 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 rule in the Federal Register. This rule is not a
``major rule '' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

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

    Dated: July 17, 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 180.960 is amended in the table by removing the entry for
``[alpha]-Butyl-[omega]-hydroxypoly(oxypropylene) block polymer with
poly(oxyethylene); molecular weight (in amu) 2,400--3,500'' and by
alphabetically adding a polymer to read as follows:

Sec.  180.960  Polymers; exemptions from the requirement of a
tolerance.

* * * * *

------------------------------------------------------------------------
                          Polymer                              CAS No.
------------------------------------------------------------------------
                                * * * * *
Oxirane, methyl-, polymer with Oxirane, Monobutyl Ether        9038-95-3
                                * * * * *
------------------------------------------------------------------------

[FR Doc. E6-11952 Filed 7-25-06; 8:45 am]

BILLING CODE 6560-50-S