[Federal Register Volume 80, Number 82 (Wednesday, April 29, 2015)]
[Rules and Regulations]
[Pages 23708-23709]
[FR Doc No: 2015-09873]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2014-0741; Airspace Docket No. 14-ASW-4]

Establishment of Class E Airspace; Encinal, TX

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: This action establishes Class E airspace at Encinal, TX.
Controlled airspace is necessary to accommodate new Standard Instrument
Approach Procedures (SIAPs) at El Jardin Ranch Airport. The FAA is
taking this action to enhance the safety and management of Instrument
Flight Rules (IFR) operations for SIAPs at the airport.

DATES: Effective 0901 UTC, June 25, 2015. The Director of the Federal
Register approves this incorporation by reference action under title 1,
Code of Federal Regulations, part 51, subject to the annual revision of
FAA Order 7400.9 and publication of conforming amendments.

ADDRESSES: FAA Order 7400.9Y, Airspace Designations and Reporting
Points, and subsequent amendments can be viewed on line at http://www.faa.gov/airtraffic/publications/. The Order is also available for
inspection at the National Archives and Records Administration (NARA).
For information on the availability of this material at NARA, call 202-
741-6030, or go to http://www.archives.gov/federal_register/code_of_federal-regulations/ibr_locations.html.
    FAA Order 7400.9, Airspace Designations and Reporting Points, is
published yearly and effective on September 15. For further
information, you can contact the Airspace Policy and ATC Regulations
Group, Federal Aviation Administration, 800 Independence Avenue SW.,
Washington, DC 29591; telephone:<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Rebecca Shelby, Central Service
Center, Operations Support Group, Federal Aviation Administration,
Southwest Region, 2601 Meacham Blvd., Fort Worth, TX 76137; telephone:
817-321-7740.

SUPPLEMENTARY INFORMATION:

History

    On October 28, 2014, the FAA published in the Federal Register a
notice of proposed rulemaking (NPRM) to establish Class E airspace at
El Jardin Ranch Airport, Encinal, TX, (79 FR 64153). Interested parties
were invited to participate in this rulemaking effort by submitting
written comments on the proposal to the FAA. No comments were received.
    Class E airspace designations are published in Paragraphs 6005,
respectively, of FAA Order 7400.9Y, dated August 6, 2014, and effective
September 15, 2014, which is incorporated by reference in 14 CFR 71.1.
The Class E airspace designations listed in this document will be
published subsequently in the Order.

Availability and Summary of Documents for Incorporation by Reference

    This document amends FAA Order 7400.9Y, airspace Designations and
Reporting Points, dated August 6, 2014, and effective September 15,
2014. FAA Order 7400.9Y is publicly available as listed in the
ADDRESSES section of this final rule. FAA Order 7400.9Y lists Class A,
B, C, D, and E airspace areas, air traffic service routes, and
reporting points.

The Rule

    This action amends Title 14, Code of Federal Regulations (14 CFR),
Part 71 by establishing Class E airspace extending upward from 700 feet
above the surface within a 7-mile radius of El Jardin Ranch Airport,
Encinal, TX, to accommodate new Standard Instrument Approach Procedures
at airport. The FAA is taking this action to enhance the safety and
management of IFR operations at the airport.
    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
Therefore, this regulation: (1) Is not a ``significant regulatory
action'' under Executive Order 12866; (2) is not a ``significant rule''
under DOT Regulatory Policies and Procedures (44 FR 11034; February 26,
1979); and (3) does not warrant preparation of a regulatory evaluation
as the anticipated impact is so minimal. Since this is a routine matter
that only affects air traffic procedures and air navigation, it is
certified that this rule, when promulgated, does not have a significant
economic impact on a substantial number of small entities under the
criteria of the Regulatory Flexibility Act.
    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the U.S. Code. Subtitle 1, Section 106, describes
the authority of the FAA Administrator. Subtitle VII, Aviation
Programs, describes in more detail the scope of the agency's authority.
This rulemaking is promulgated under the authority described in
Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the
FAA is charged with prescribing regulations to assign the use of
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as it establishes controlled airspace at El Jardin Ranch Airport,
Encinal, TX.

Environmental Review

    The FAA has determined that this action qualifies for categorical
exclusion under the National Environmental Policy Act in accordance
with FAA Order 1050.1E. ``Environmental Impacts: Policies and
Procedures,'' paragraph 311a. This airspace action is not expected to
cause any potentially significant environmental impacts, and no
extraordinary circumstances exist that warrant preparation of an
environmental assessment.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

Adoption of the Amendment

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

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

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

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

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of FAA Order 7400.9Y,
Airspace Designations and Reporting Points, dated August 6, 2014 and
effective September 15, 2014, is amended as follows:

Paragraph 6005 Class E Airspace Areas Extending Upward From 700
Feet or More Above the Surface of the Earth.

* * * * *

ASW TX E5 Encinal, TX [New]

El Jardin Ranch Airport, TX
    (Lat. 28[deg]04'26'' N., long. 99[deg]17'5.0'' W.)

    That airspace extending upward from 700 feet above the surface
within a 7-mile radius of El Jardin Ranch Airport.

    Issued in Fort Worth, TX, on April 21, 2015.
Robert W. Beck,
Manager, Operations Support Group, ATO Central Service Center.
[FR Doc. 2015-09873 Filed 4-28-15; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 82, Number 166 (Tuesday, August 29, 2017)]
[Rules and Regulations]
[Pages 40953-40957]
[FR Doc No: 2017-18213]

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

 ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 52 and 81

[EPA-R04-OAR-2017-0085; FRL-9966-92-Region 4]

Air Plan Approval and Air Quality Designation; TN; Redesignation
of the Knoxville 1997 Annual PM2.5 Nonattainment Area to
Attainment

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: On December 20, 2016, Tennessee, through the Tennessee
Department of Environment and Conservation (TDEC), submitted a request
for the Environmental Protection Agency (EPA) to redesignate the
Knoxville, Tennessee fine particulate matter (PM2.5)
nonattainment area (hereinafter referred to as the ``Knoxville Area''
or ``Area'') to attainment for the 1997 Annual PM2.5
national ambient air quality standards (NAAQS) and to approve a state
implementation plan (SIP) revision containing a maintenance plan, a
reasonably available control measures (RACM) determination, and source-
specific requirements for the Area. EPA is approving Tennessee's RACM
determination for the Knoxville Area and incorporating it into the SIP;
incorporating source-specific requirements for two sources in the Area
into the SIP; determining that the Knoxville Area is attaining the 1997
Annual PM2.5 NAAQS based on 2013-2015 data; approving
Tennessee's plan for maintaining the 1997 Annual PM2.5 NAAQS
for the Knoxville Area (maintenance plan), including the associated
motor vehicle emission budgets (MVEBs) for nitrogen oxides
(NOX) and direct PM2.5 for the years 2014 and
2028, and incorporating it into the SIP; and redesignating the
Knoxville Area to attainment for the 1997 Annual PM2.5
NAAQS.

DATES: This rule will be effective August 29, 2017.

ADDRESSES: EPA has established a docket for this action under Docket
Identification No. EPA-R04-OAR-2017-0085. All documents in the docket
are listed on the www.regulations.gov Web site. Although listed in the
index, some information may not be publicly available, i.e.,
Confidential Business Information 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 either electronically through www.regulations.gov or in hard
copy at the Air Regulatory Management Section, Air Planning and
Implementation Branch, Air, Pesticides and Toxics Management Division,
U.S. Environmental Protection Agency, Region 4, 61 Forsyth Street SW.,
Atlanta, Georgia 30303-8960. EPA requests that if at all possible, you
contact the person listed in the FOR FURTHER INFORMATION CONTACT
section to schedule your inspection. The Regional Office's official
hours of business are Monday through Friday 8:30 a.m. to 4:30 p.m.,
excluding federal holidays.

FOR FURTHER INFORMATION CONTACT: Sean Lakeman of the Air Regulatory
Management Section, in the Air Planning and Implementation Branch, Air,
Pesticides and Toxics Management Division, U.S. Environmental
Protection Agency, Region 4, 61 Forsyth Street SW., Atlanta, Georgia
30303-8960. Sean Lakeman may be reached by phone at<PHONE_NUMBER>, or
via electronic mail at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    On July 18, 1997, EPA promulgated the first air quality standards
for PM2.5. EPA promulgated an annual standard at a level of
15.0 micrograms per cubic meter ([mu]g/m\3\), based on a 3-year average
of annual mean PM2.5 concentrations. In the same rulemaking,
EPA promulgated a 24-hour standard of 65 [mu]g/m\3\, based on a 3-year
average of the 98th percentile of 24-hour concentrations. On October
17, 2006 (71 FR 61144), EPA retained the annual average NAAQS at 15.0
[mu]g/m\3\ but revised the 24-hour NAAQS to 35 [mu]g/m\3\, based again
on the 3-year average of the 98th percentile of 24-hour concentrations.
    On January 5, 2005, at 70 FR 944, and supplemented on April 14,
2005, at 70 FR 19844, EPA designated the Knoxville Area as
nonattainment for the 1997 Annual PM2.5 NAAQS. All 1997
PM2.5 NAAQS areas were designated under title I, part D,
subpart 1 (hereinafter ``Subpart 1''). Subpart 1 contains the general
requirements for nonattainment areas for any pollutant governed by a
NAAQS and is less prescriptive than the other subparts of title I, part
D. On April 25, 2007 (72 FR 20586), EPA promulgated its Clean Air Fine
Particle Implementation Rule, codified at 40

CFR part 51, subpart Z, in which the Agency provided guidance for state
and tribal plans to implement the 1997 PM2.5 NAAQS. The
United States Court of Appeals for the District of Columbia Circuit
(D.C. Circuit) remanded the Clean Air Fine Particle Implementation Rule
and the final rule entitled ``Implementation of the New Source Review
(NSR) Program for Particulate Matter Less than 2.5 Micrometers
(PM2.5)'' (73 FR 28321, May 16, 2008) (collectively, ``1997
PM2.5 Implementation Rules'') to EPA on January 4, 2013, in
Natural Resources Defense Council v. EPA, 706 F.3d 428 (D.C. Cir.
2013). The Court found that EPA erred in implementing the 1997
PM2.5 NAAQS pursuant to the general implementation
provisions of Subpart 1, rather than the particulate matter-specific
provisions of title I, part D, subpart 4 (hereinafter ``Subpart 4'').
    On June 2, 2014, EPA published a rule entitled ``Identification of
Nonattainment Classification and Deadlines for Submission of State
Implementation Plan (SIP) Provisions for the 1997 Fine Particle
(PM2.5) National Ambient Air Quality Standard (NAAQS) and
2006 PM2.5 NAAQS''. See 79 FR 31566. In that rule, the
Agency responded to the D.C. Circuit's January 2013 decision by
identifying all PM2.5 nonattainment areas for the 1997 and
2006 PM2.5 NAAQS as ``moderate'' nonattainment areas under
Subpart 4, and by establishing a new SIP submission date of December
31, 2014, for moderate area attainment plans and for any additional
attainment-related or nonattainment new source review plans necessary
for areas to comply with the requirements applicable under Subpart 4.
Id. at 31567-70.
    Based on its moderate nonattainment area classification, Tennessee
was required to submit a SIP revision addressing RACM pursuant to CAA
section 172(c)(1) and section 189(a)(1)(C) for the Area. Although EPA
does not believe that section 172(c)(1) and section 189(a)(1)(C) RACM
must be approved into a SIP prior to redesignation of an area to
attainment once that area is attaining the NAAQS, EPA is approving
Tennessee's RACM determination and incorporating it into its SIP
pursuant to a recent decision by the United States Court of Appeals for
the Sixth Circuit in Sierra Club v. EPA, 793 F.3d 656 (6th Cir. 2015).
    In a notice of proposed rulemaking (NPRM) published on May 30, 2017
(82 FR 24636), EPA proposed to: (1) Approve Tennessee's RACM
determination for the Knoxville Area pursuant to CAA sections 172(c)(1)
and 189(a)(1)(C) and incorporate it into the SIP; (2) determine that
the Knoxville Area is attaining the 1997 Annual PM2.5 NAAQS
based on 2013-2015 air quality data; (3) approve Tennessee's
maintenance plan for the Knoxville Area, including the 2014 and 2028
MVEBs for PM2.5 and NOX, and incorporate it into
the SIP; (4) incorporate source-specific requirements for two sources
located in the Area--the Tennessee Valley Authority (TVA) Bull Run
Fossil Plant and TVA Kingston Fossil Plant--into the SIP; and (5)
redesignate the Knoxville Area to attainment for the 1997 Annual
PM2.5 NAAQS.\1\ The details of Tennessee's submittal and the
rationale for EPA's actions are further explained in the NPRM. EPA did
not receive any adverse comments on the proposed action.
---------------------------------------------------------------------------

    \1\ In a notice published in the Federal Register on March 10,
2017, EPA announced that it had found the MVEBs for the Knoxville
Area for the 1997 Annual PM2.5 NAAQS adequate for
transportation conformity purposes. See 82 FR 13337.
---------------------------------------------------------------------------

II. What are the effects of these actions?

    EPA's approval changes the legal designation of Anderson, Blount,
Knox, and Loudon Counties and a portion of Roane County for the 1997
Annual PM2.5 NAAQS, found at 40 CFR part 81, from
nonattainment to attainment. Approval of Tennessee's associated SIP
revision also incorporates a plan for maintaining the 1997 Annual
PM2.5 NAAQS in the Area through 2028, Tennessee's RACM
determination, and source-specific requirements for two sources in the
Area into the Tennessee SIP. The maintenance plan includes contingency
measures to remedy any future violations of the 1997 Annual
PM2.5 NAAQS and procedures for evaluation of potential
violations. The maintenance plan also includes NOX and
PM2.5 MVEBs for 2014 and 2028 for the Knoxville Area. The
2014 and 2028 PM2.5 MVEBs are 444.78 tons per year (tpy) and
245.00 tpy, respectively. The 2014 and 2028 NOX MVEBs are
15,597.73 tpy and 7,171.14 tpy, respectively.
    In the Fine Particulate Matter National Ambient Air Quality
Standards: State Implementation Plan Requirements final rule
(PM2.5 SIP Requirements Rule), EPA revoked the 1997 primary
Annual PM2.5 NAAQS in areas that had always been attainment
for that NAAQS, and in areas that had been designated as nonattainment
but that were redesignated to attainment before October 24, 2016, the
rule's effective date. See 81 FR 58010 (August 24, 2016). EPA also
finalized a provision that revokes the 1997 primary Annual
PM2.5 NAAQS in areas that are redesignated to attainment for
that NAAQS after October 24, 2016, effective on the effective date of
the redesignation of the area to attainment for that NAAQS. See 40 CFR
50.13(d).
    EPA is finalizing the redesignation of the Knoxville Area to
attainment for the 1997 Annual PM2.5 NAAQS and finalizing
the approval of the CAA section 175A maintenance plan for the 1997
primary Annual PM2.5 NAAQS.\2\ Therefore, the 1997 primary
Annual PM2.5 NAAQS will be revoked in the Knoxville Area on
the effective date of this redesignation, August 29, 2017. Beginning on
that date, the Area will no longer be subject to transportation or
general conformity requirements for the 1997 Annual PM2.5
NAAQS due to the revocation of the primary NAAQS. See 81 FR 58125
(August 24, 2016). The Area is required to implement the CAA section
175A maintenance plan for the 1997 primary Annual PM2.5
NAAQS that is being approved in this action and the prevention of
significant deterioration program for the 1997 Annual PM2.5
NAAQS. The approved maintenance plan can only be revised if the
revision meets the requirements of CAA section 110(l) and, if
applicable, CAA section 193. The Area is not required to submit a
second 10-year maintenance plan for the 1997 primary Annual
PM2.5 NAAQS. See 81 FR 58144 (August 24, 2016).
---------------------------------------------------------------------------

    \2\ CAA section 175A(a) establishes the maintenance plan
requirements that must be fulfilled by nonattainment areas in order
to be redesignated to attainment. That section only requires that
nonattainment areas for the primary standard submit a plan
addressing maintenance of the primary NAAQS in order to be
redesignated to attainment; it does not require nonattainment areas
for secondary NAAQS to submit maintenance plans in order to be
redesignated to attainment. See 42 U.S.C. 7505a(a).
---------------------------------------------------------------------------

III. Incorporation by Reference

    In this rule, EPA is finalizing regulatory text that includes
incorporation by reference. In accordance with requirements of 1 CFR
51.5, EPA is finalizing the incorporation by reference of the following
Title V permit limits and conditions in Appendix L of Tennessee's
December 20, 2016 SIP revision, state effective on December 20, 2016:
Permit conditions E3-4(a), (d), and (e), E3-15, and E3-16 for the TVA
Kingston Fossil Plant, and permit conditions E3-4(a), (d), and (e), E3-
15, and E3-16 for the TVA Bull Run Fossil Plant. Therefore, these
materials have been approved by EPA for inclusion in the State
implementation plan, have been incorporated by reference by EPA into
that plan, are fully federally enforceable under sections 110 and 113
of the CAA as of

the effective date of the final rulemaking of EPA's approval, and will
be incorporated by reference by the Director of the Federal Register in
the next update to the SIP compilation.\3\ EPA has made, and will
continue to make, these materials generally available through
www.regulations.gov and/or at the EPA Region 4 Office (please contact
the person identified in the For Further Information Contact section of
this preamble for more information).
---------------------------------------------------------------------------

    \3\ 62 FR 27968 (May 22, 1997).
---------------------------------------------------------------------------

IV. Final Actions

    EPA is taking the following final actions: (1) Approving
Tennessee's RACM determination for the Knoxville Area pursuant to CAA
sections 172(c)(1) and 189(a)(1)(C) and incorporating it into the SIP;
(2) determining that the Area is attaining the 1997 Annual
PM2.5 NAAQS based on 2013-2015 data; (3) approving
Tennessee's plan for maintaining the 1997 Annual PM2.5 NAAQS
(maintenance plan), including the associated 2014 and 2028 MVEBs for
the Knoxville Area, and incorporating it into the Tennessee SIP; (4)
incorporating source-specific requirements for two sources in the Area
into the SIP; and (5) redesignating the Knoxville Area to attainment
for the 1997 Annual PM2.5 NAAQS.
    Approval of the redesignation request changes the official
designation of Anderson, Blount, Knox, and Loudon Counties and a
portion of Roane County for the 1997 Annual PM2.5 NAAQS,
found at 40 CFR part 81 from nonattainment to attainment.
    As mentioned above, the PM2.5 SIP Requirements Rule
provides that the 1997 PM2.5 NAAQS will be revoked for any
area that is redesignated for the NAAQS upon the effective date of the
redesignation. Therefore, the 1997 primary Annual PM2.5
NAAQS is revoked for the Knoxville Area on the effective date of this
redesignation.
    EPA has determined that these actions are effective immediately
upon publication under the authority of 5 U.S.C. 553(d). The purpose of
the 30-day waiting period prescribed in section 553(d) is to give
affected parties a reasonable time to adjust their behavior and prepare
before the final rule takes effect. Section 553(d)(3) allows an
effective date less than 30 days after publication ``as otherwise
provided by the agency for good cause found and published with the
rule.'' EPA finds good cause to make these actions effective
immediately pursuant to section 553(d)(3) because they do not create
any new regulatory requirements such that affected parties would need
time to prepare before the actions take effect. The RACM determination
does not create any new regulatory requirements because it concludes
that no additional measures are necessary to meet the State's
obligations to have fully adopted RACM; incorporating the
aforementioned Title V permit terms and conditions for the TVA Bull Run
Fossil Plant and the TVA Kingston Fossil Plant into the SIP does not
create any new regulatory requirements because these sources were
subject, and remain subject, to these terms and conditions through
their Title V permits; and redesignating the Area to attainment,
including the associated determination of attainment and maintenance
plan approval, relieves the Area from certain CAA requirements that
would otherwise apply to it. Because the redesignation relieves the
Area from requirements, its immediate effective date is also authorized
under section 553(d)(1) which allows an effective date less than 30
days after publication if a substantive rule ``relieves a
restriction.''

V. Statutory and Executive Order Reviews

    Under the CAA, redesignation of an area to attainment and the
accompanying approval of a maintenance plan under section 107(d)(3)(E)
are actions that affect the status of a geographical area and do not
impose any additional regulatory requirements on sources beyond those
imposed by state law. A redesignation to attainment does not in and of
itself create any new requirements, but rather results in the
applicability of requirements contained in the CAA for areas that have
been redesignated to attainment. Moreover, the Administrator is
required to approve a SIP submission that complies with the provisions
of the Act and applicable Federal regulations. See 42 U.S.C. 7410(k);
40 CFR 52.02(a). Thus, in reviewing SIP submissions, EPA's role is to
approve state choices, provided that they meet the criteria of the CAA.
Accordingly, these actions merely approve state law as meeting federal
requirements and do not impose additional requirements beyond those
imposed by state law. For that reason, these actions:
     Are not significant regulatory actions subject to review
by the Office of Management and Budget under Executive Order 12866 (58
FR 51735, October 4, 1993) and 13563 (76 FR 3821, January, 21, 2011);
     Do not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Are certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Do not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Do not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Are not economically significant regulatory actions based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Are not significant regulatory actions subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Are not subject to requirements of section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     Will not have disproportionate human health or
environmental effects under Executive Order 12898 (59 FR 7629, February
16, 1994).
    In addition, the SIP is not approved to apply on any Indian
reservation land or in any other area where EPA or an Indian tribe has
demonstrated that a tribe has jurisdiction. In those areas of Indian
country, the rule does not have tribal implications as specified by
Executive Order 13175 (65 FR 67249, November 9, 2000), nor will it
impose substantial direct costs of tribal governments or preempt tribal
law.
    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 action 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 the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by October 30, 2017. Filing a

petition for reconsideration by the Administrator of this final rule
does not affect the finality of this action for the purposes of
judicial review nor does it extend the time within which a petition for
judicial review may be filed, and shall not postpone the effectiveness
of such rule or action. This action may not be challenged later in
proceedings to enforce its requirements. See section 307(b)(2).

List of Subjects

40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Nitrogen oxides, Particulate
matter, Reporting and recordkeeping requirements, Sulfur oxides,
Volatile organic compounds.

40 CFR Part 81

    Environmental protection, Air pollution control.

    Dated: August 16, 2017.
V. Anne Heard,
Acting Regional Administrator, Region 4.
    40 CFR parts 52 and 81 are amended as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

0
1. The authority citation for part 52 continues to read as follows:

    Authority: 42 U.S.C. 7401 et seq.

Subpart RR--Tennessee

0
2. In Sec.  52.2220:
0
a. The table in paragraph (d) is amended by adding the entries ``TVA
Bull Run Fossil Plant'' and ``TVA Kingston Fossil Plant'' at the end of
the table.
0
b. The table in paragraph (e) is amended by adding the entries ``1997
Annual PM2.5 Maintenance Plan for the Knoxville Area'' and
``RACM determination for the Knoxville Area for the 1997 Annual
PM2.5 NAAQS'' at the end of the table.
    The additions read as follows:

Sec.  52.2220   Identification of plan.

* * * * *
    (d) * * *

                               EPA-Approved Tennessee Source-Specific Requirements
----------------------------------------------------------------------------------------------------------------
                                                             State
          Name of source                Permit No.      effective date   EPA approval date       Explanation
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
TVA Bull Run Fossil Plant........  n/a................      12/20/2016  8/29/2017, [insert   Title V permit
                                                                         Federal Register     limits and
                                                                         citation].           conditions E3-
                                                                                4(a), (d), and
                                                                                (e), E3-15, and E3-
                                                                                16 in Appendix L
                                                                                of Tennessee's
                                                                                December 20, 2016
                                                                                SIP revision.
TVA Kingston Fossil Plant........  n/a................      12/20/2016  8/29/2017, [insert   Title V permit
                                                                         Federal Register     limits and
                                                                         citation].           conditions E3-
                                                                                4(a), (d), and
                                                                                (e), E3-15, and E3-
                                                                                16 in Appendix L
                                                                                of Tennessee's
                                                                                December 20, 2016
                                                                                SIP revision.
----------------------------------------------------------------------------------------------------------------

    (e) * * *

                                EPA-Approved Tennessee Non-Regulatory Provisions
----------------------------------------------------------------------------------------------------------------
                                        Applicable
    Name of non-regulatory SIP        geographic or          State       EPA approval date       Explanation
            provision               nonattainment area  effective date
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
1997 Annual PM2.5 Maintenance      Anderson, Blount,        12/20/2016  8/29/2017, [insert
 Plan for the Knoxville Area.       Knox, and Loudon                     Federal Register
                                    Counties and a                       citation].
                                    portion of Roane
                                    County (the area
                                    described by U.S.
                                    Census 2000 block
                                    group identifier
                                    47-145-0307-2.).
RACM determination for the         Anderson, Blount,        12/20/2016  8/29/2017, [insert
 Knoxville Area for the 1997        Knox, and Loudon                     Federal Register
 Annual PM2.5 NAAQS.                Counties and a                       citation].
                                    portion of Roane
                                    County (the area
                                    described by U.S.
                                    Census 2000 block
                                    group identifier
                                    47-145-0307-2.).
----------------------------------------------------------------------------------------------------------------

PART 81--DESIGNATION OF AREAS FOR AIR QUALITY PLANNING PURPOSES

0
3. The authority citation for part 81 continues to read as follows:

    Authority: 42 U.S.C. 7401 et seq.

0
4. In Sec.  81.343, the table entitled ``Tennessee--1997 Annual
PM2.5 NAAQS [Primary and secondary]'' is amended by revising
the entry ``Knoxville, TN:'' to read as follows:

Sec.  81.343  Tennessee.

* * * * *

                                       Tennessee--1997 Annual PM2.5 NAAQS
                                             [Primary and secondary]
----------------------------------------------------------------------------------------------------------------
                                                    Designation \a\                       Classification
           Designated area           ---------------------------------------------------------------------------
                                         Date \1\                Type                Date \2\          Type
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
Knoxville, TN.......................       8/29/2017  Attainment................
    Anderson County.................  ..............  Attainment................
    Blount County...................  ..............  Attainment................
    Knox County.....................  ..............  Attainment................
    Loudon County...................  ..............  Attainment................
    Roane County (part).............  ..............  Attainment................
The area described by U.S. Census
 2000 block group identifier 47-145-
 0307-2.

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
\a\ Includes Indian Country located in each county or area, except as otherwise specified.
\1\ This date is 90 days after January 5, 2005, unless otherwise noted.
\2\ This date is July 2, 2014, unless otherwise noted.

* * * * *
[FR Doc. 2017-18213 Filed 8-28-17; 8:45 am]
BILLING CODE 6560-50-P


Inyx/ Aventis Response to Section 114 letter Confidential Business Information located at EPA headquarters 1310 L St NW


[Federal Register Volume 80, Number 138 (Monday, July 20, 2015)]
[Rules and Regulations]
[Pages 42733-42735]
[FR Doc No: 2015-17683]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R04-OAR-2015-0368; FRL-9930-76-Region 4]

Approval and Promulgation of Implementation Plans; North
Carolina; Nitrogen Dioxide and Sulfur Dioxide National Ambient Air
Quality Standards Changes

AGENCY: Environmental Protection Agency (EPA).

ACTION: Direct final rule.

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

SUMMARY: The Environmental Protection Agency (EPA) is taking direct
final action to approve the State Implementation Plan (SIP) revision
submitted by the State of North Carolina, through the North Carolina
Department of Environment and Natural Resources on August 13, 2012,
pertaining to definition changes for the Nitrogen Dioxide
(NO2) and Sulfur Dioxide (SO2) National Ambient
Air Quality Standards (NAAQS). EPA is approving this SIP revision
because the State has demonstrated that it is consistent with the Clean
Air Act (CAA or Act).

DATES: This direct final rule is effective on September 18, 2015
without further notice, unless EPA receives relevant adverse comment by
August 19, 2015. If EPA receives such comment, EPA will publish a
timely withdrawal in the Federal Register informing the public that
this rule will not take effect.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R04-
OAR-2015-0368, by one of the following methods:
    1. www.regulations.gov: Follow the on-line instructions for
submitting comments.
    2. Email<EMAIL_ADDRESS>    3. Fax:<PHONE_NUMBER>.
    4. Mail: ``EPA-R04-OAR-2015-0368'' Air Regulatory Management
Section (formerly the Regulatory Development Section), Air Planning and
Implementation Branch (formerly the Air Planning Branch), Air,
Pesticides and Toxics Management Division, U.S. Environmental
Protection Agency, Region 4, 61 Forsyth Street SW., Atlanta, Georgia
30303-8960.
    5. Hand Delivery or Courier: Lynorae Benjamin, Chief, Air
Regulatory Management Section, Air Planning and Implementation Branch,
Air, Pesticides and Toxics Management Division, U.S. Environmental
Protection Agency, Region 4, 61 Forsyth Street, SW., Atlanta, Georgia
30303-8960. Such deliveries are only accepted during the Regional
Office's normal hours of operation. The Regional Office's official
hours of business are Monday through Friday, 8:30 a.m. to 4:30 p.m.,
excluding Federal holidays.
    Instructions: Direct your comments to Docket ID No. ``EPA-R04-OAR-
2015-0368''. EPA's policy is that all comments received will be
included in the public docket without change and may be made available
online at www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit through
www.regulations.gov or email, information that you consider to be CBI
or otherwise protected. The www.regulations.gov Web site is an
``anonymous access'' system, which means EPA will not know your
identity or contact information unless you provide it in the body of
your comment. If you send an email comment directly to EPA without
going through www.regulations.gov, your email address will be
automatically captured and included as part of the comment that is
placed in the public docket and made available on the Internet. If you
submit an electronic comment, EPA recommends that you include your name
and other contact information in the body of your comment and with any
disk or CD-ROM you submit. If EPA cannot read your comment due to
technical difficulties and cannot contact you for clarification, EPA
may not be able to consider your comment. Electronic files should avoid
the use of special characters, any form of encryption, and be free of
any defects or viruses. For additional information about EPA's public
docket visit the EPA Docket Center homepage at http://www.epa.gov/epahome/dockets.htm.
    Docket: All documents in the electronic docket are listed in the
www.regulations.gov index. Although listed in the index, some
information is not publicly available, i.e., 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 either electronically in www.regulations.gov or
in hard copy at the Air Regulatory Management Section, Air Planning and
Implementation Branch, Air, Pesticides and Toxics Management Division,
U.S. Environmental Protection Agency, Region 4, 61 Forsyth Street, SW.,
Atlanta, Georgia 30303-8960. EPA

requests that if at all possible, you contact the person listed in the
FOR FURTHER INFORMATION CONTACT section to schedule your inspection.
The Regional Office's official hours of business are Monday through
Friday, 8:30 a.m. to 4:30 p.m., excluding Federal holidays.

FOR FURTHER INFORMATION CONTACT: Zuri Farngalo, Air Regulatory
Management Section, Air Planning and Implementation Branch, Air,
Pesticides and Toxics Management Division, U.S. Environmental
Protection Agency, Region 4, 61 Forsyth Street SW., Atlanta, Georgia
30303-8960. The telephone number is<PHONE_NUMBER>. Mr. Farngalo can be
reached via electronic mail at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    Sections 108 and 109 of the CAA govern the establishment, review,
and revision, as appropriate, of the NAAQS to protect public health and
welfare. The CAA requires periodic review of the air quality criteria--
the science upon which the standards are based--and the standards
themselves. EPA's regulatory provisions that govern the NAAQS are found
at 40 CFR 50--National Primary and Secondary Ambient Air Quality
Standards. In this rulemaking, EPA is proposing to approve North
Carolina's August 13, 2012, submission amending the State's NAAQS for
NO2 and SO2 that are found at 15A NCAC 02D .0407
and .0402. The SIP submittal amending North Carolina's rules to
incorporate the NAAQS can be found in the Docket for this proposed
rulemaking at www.regulations.gov and are summarized below.

II. EPA's Analysis of North Carolina's SIP Revision

A. NO2

    On February 9, 2010, EPA promulgated a new 1-hour primary NAAQS for
NO2 at a level of 100 parts per billion (ppb), based on a 3-
year average of the 98th percentile of the yearly distribution of 1-
hour daily maximum concentrations. See 75 FR 6474. Accordingly, in the
August 3, 2012, SIP submission, North Carolina revised state rule 15A
NCAC 02D .0407 Nitrogen Dioxide to update the primary air quality
standard for NO2 to be consistent with the NAAQS that were
promulgated by EPA in 2010. EPA has reviewed this change to North
Carolina's rule for NO2 and has made the determination that
this change is consistent with federal regulations.

B. SO2

    On June 22, 2010, EPA promulgated a revised primary SO2
NAAQS to an hourly standard of 75 ppb based on a 3-year average of the
annual 99th percentile of 1-hour daily maximum concentrations. See 75
FR 35520. Accordingly, in the August 3, 2012, SIP submission, North
Carolina revised state rule 15A NCAC 02D .0402 Sulfur Oxides to update
the primary air quality standard for SO2 to be consistent
with the SO2 NAAQS that were promulgated by EPA in 2010. EPA
has reviewed the change to North Carolina's rule for SO2 and
has made the determination that these changes are consistent with
federal regulations.

III. Incorporation by Reference

    In this rule, EPA is finalizing regulatory text that includes
incorporation by reference. In accordance with requirements of 1 CFR
51.5, EPA is finalizing the incorporate by reference of NCDENR
regulations 15A NCAC 02D .0407 Nitrogen Dioxide and 15A NCAC 02D .0402
Sulfur Oxides effective September 1, 2011, which were revised to be
consistent with the current NAAQS. EPA has made, and will continue to
make, these documents generally available electronically through
www.regulations.gov and/or in hard copy at the appropriate EPA office
(see the ADDRESSES section of this preamble for more information).

IV. Final Action

    EPA is approving the aforementioned changes to the North Carolina
SIP, because they are consistent with EPA's standards for
NO2 and SO2. EPA is publishing this rule without
prior proposal because the Agency views this as a noncontroversial
submittal and anticipates no adverse comments. However, in the proposed
rules section of this Federal Register publication, EPA is publishing a
separate document that will serve as the proposal to approve the SIP
revision should adverse comments be filed. This rule will be effective
September 18, 2015 without further notice unless the Agency receives
adverse comments by August 19, 2015.
    If EPA receives such comments, then EPA will publish a document
withdrawing the final rule and informing the public that the rule will
not take effect. All adverse comments received will then be addressed
in a subsequent final rule based on the proposed rule. EPA will not
institute a second comment period. Parties interested in commenting
should do so at this time. If no such comments are received, the public
is advised that this rule will be effective on September 18, 2015 and
no further action will be taken on the proposed rule.
    Please note that if EPA receives adverse comment on an amendment,
paragraph, or section of this rule and if that provision may be severed
from the remainder of the rule, the Agency may adopt as final those
provisions of the rule that are not the subject of an adverse comment.

V. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the Act and applicable
Federal regulations. See 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. Accordingly, this
action merely approves state law as meeting Federal requirements and
does not impose additional requirements beyond those imposed by state
law. For that reason, this action:
     Is not a significant regulatory action subject to review
by the Office of Management and Budget under Executive Orders 12866 (58
FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
     does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human

health or environmental effects, using practicable and legally
permissible methods, under Executive Order 12898 (59 FR 7629, February
16, 1994).
    The SIP is not approved to apply on any Indian reservation land or
in any other area where EPA or an Indian tribe has demonstrated that a
tribe has jurisdiction. In those areas of Indian country, the rule does
not have tribal implications as specified by Executive Order 13175 (65
FR 67249, November 9, 2000), nor will it impose substantial direct
costs on tribal governments or preempt tribal law.
    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 action 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 the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by September 18, 2015. Filing a petition for
reconsideration by the Administrator of this final rule does not affect
the finality of this action for the purposes of judicial review nor
does it extend the time within which a petition for judicial review may
be filed, and shall not postpone the effectiveness of such rule or
action. Parties with objections to this direct final rule are
encouraged to file a comment in response to the parallel notice of
proposed rulemaking for this action published in the proposed rules
section of today's Federal Register, rather than file an immediate
petition for judicial review of this direct final rule, so that EPA can
withdraw this direct final rule and address the comment in the proposed
rulemaking. This action may not be challenged later in proceedings to
enforce its requirements. See section 307(b)(2).

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Nitrogen dioxide, Sulfur
dioxide, Reporting and recordkeeping requirements.

    Dated: July 6, 2015.
Heather McTeer Toney,
Regional Administrator, Region 4.

    40 CFR part 52 is amended as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

0
1. The authority citation for part 52 continues to read as follows:

    Authority:  42. U.S.C. 7401 et seq.

Subpart II--North Carolina

0
2. Section 52.1770(c) is amended under Table 1, at Subchapter 2D Air
Pollution Control Requirements, Section .0400 Ambient Air Quality
Standards by revising the entries for ``.0402,'' and ``.0407'' to read
as follows:

Sec.  52.1770  Identification of plan.

* * * * *
    (c) * * *

                                Table 1--EPA Approved North Carolina Regulations
----------------------------------------------------------------------------------------------------------------
                                                               State
         State citation               Title/subject       effective date  EPA approval date      Explanation
----------------------------------------------------------------------------------------------------------------
                                Subchapter 2D Air Pollution Control Requirements
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
                                   Section .0400 Ambient Air Quality Standards
----------------------------------------------------------------------------------------------------------------

                                                   * * * * * *
Sect .0402.....................  Sulfur Dioxide.........        9/1/2011  7/20/2015 [Insert
                                                                           citation of
                                                                           publication].

                                                  * * * * * * *
Sect .0407.....................  Nitrogen Dioxide.......        9/1/2011  7/20/2015 [Insert  ...................
                                                                           citation of
                                                                           publication].

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

* * * * *
[FR Doc. 2015-17683 Filed 7-17-15; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 80, Number 207 (Tuesday, October 27, 2015)]
[Notices]
[Page 65730]
[FR Doc No: 2015-27174]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER16-90-000]

Golden Hills Interconnection, LLC; Supplemental Notice That
Initial Market-Based Rate Filing Includes Request for Blanket Section
204 Authorization

    This is a supplemental notice in the above-referenced proceeding of
Golden Hills Interconnection, LLC.'s application for market-based rate
authority, with an accompanying rate tariff, noting that such
application includes a request for blanket authorization, under 18 CFR
part 34, of future issuances of securities and assumptions of
liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street NE., Washington,
DC 20426, in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone
filing a motion to intervene or protest must serve a copy of that
document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is November 9, 2015.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
5 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First Street NE., Washington, DC 20426.
    The filings in the above-referenced proceeding are accessible in
the Commission's eLibrary system by clicking on the appropriate link in
the above list. They are also available for electronic review in the
Commission's Public Reference Room in Washington, DC. There is an
eSubscription link on the Web site that enables subscribers to receive
email notification when a document is added to a subscribed docket(s).
For assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.

    Dated: October 20, 2015.
Kimberly D. Bose,
Secretary.
[FR Doc. 2015-27174 Filed 10-26-15; 8:45 am]
BILLING CODE 6717-01-P


Date: September 21, 2012
MEMORANDUM
TO:			Air and Radiation Docket EPA-HQ-OAR-2012-0542
SUBJECT:	Meeting with Delegation from the Republic of Indonesia

	On September 21, 2012, a high-level delegation from the Republic of Indonesia met with EPA to discuss cooperation on environmental issues and renewable fuels produced from palm oil.  A partial list of attendees is below.  Minister Kambuaya thanked the EPA for hosting the meeting and emphasized Indonesia's commitment to environmental sustainability.  Deputy Administrator Perciasepe welcomed the delegation, gave an overview of EPA's process regarding the palm oil rulemaking and discussed plans for EPA to send a high-level delegation to Indonesia and Malaysia to learn more about palm oil production in the region.  Ambassador Djalal discussed the importance of palm oil to Indonesia and expressed his pleasure with respect to EPA's upcoming visit.

Partial List of Representatives from the Republic of Indonesia
1. Mr. Balthasar (Berth) Kambuaya, Minister of Environment
2. Mr. Dino Djalal, Indonesian Ambassador to the U.S.
Partial List of Representatives from EPA
Bob Perciasepe	Deputy Administrator
Michael Stahl		Acting Assistant Administrator, Office of International and Tribal Affairs
Karl Simon		Director, Transportation and Climate Division

Partial List of Representatives from U.S. Department of State
James Caruso		Economic Counselor, U.S. Embassy Jakarta


[Federal Register: May 15, 2008 (Volume 73, Number 95)]
[Rules and Regulations]
[Page 28036-28037]
[DOCID:fr15my08-8]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 522

Implantation or Injectable Dosage Form New Animal Drugs; Flunixin

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Final rule.

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

SUMMARY:  The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect approval of a supplemental abbreviated new
animal drug application (ANADA) filed by IVX Animal Health, Inc. The

supplemental ANADA provides for the veterinary prescription use of
flunixin meglumine solution by intravenous injection in lactating dairy
cattle for control of pyrexia associated with acute bovine mastitis.

DATES:  This rule is effective May 15, 2008.

FOR FURTHER INFORMATION CONTACT:  John K. Harshman, Center for
Veterinary Medicine (HFV-104), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855,<PHONE_NUMBER>, e-mail:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: IVX Animal Health, Inc., 3915 South 48th
Street Ter., St. Joseph, MO 64503, filed supplemental ANADA 200-124
that provides for veterinary prescription use of Flunixin Meglumine
Injection intravenously in lactating dairy cattle for control of
pyrexia associated with acute bovine mastitis. The supplemental ANADA
is approved as of April 24, 2008, and the regulations are amended in 21
CFR 522.970 to reflect the approval.
    In accordance with the freedom of information provisions of 21 CFR
part 20 and 21 CFR 514.11(e)(2)(ii), a summary of safety and
effectiveness data and information submitted to support approval of
this application 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.
    FDA has determined under 21 CFR 25.33(a)(1) that this action is of
a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.
    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 522

    Animal drugs.

0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs and
redelegated to the Center for Veterinary Medicine, 21 CFR part 522 is
amended as follows:

PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

0
1. The authority citation for 21 CFR part 522 continues to read as
follows:

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

0
2. In Sec.  522.970, revise paragraphs (b)(2) and (b)(4) to read as
follows:

Sec.  522.970  Flunixin.

* * * * *
    (b) * * *
    (2) See Nos. 057561 and 061623 for use as in paragraphs (e)(1),
(e)(2)(i)(A), (e)(2)(ii)(A), and (e)(2)(iii) of this section.
* * * * *
    (4) See Nos. 055529 and 059130 for use as in paragraphs (e)(1) and
(e)(2) of this section.
* * * * *

    Dated: May 6, 2008.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E8-10856 Filed 5-14-08; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register: November 6, 2008 (Volume 73, Number 216)]
[Rules and Regulations]
[Page 65982-65984]
[DOCID:fr06no08-10]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[USCG-2008-0838]
RIN 1625-AA00

Safety Zone; Christmas Holiday Boat Parade Fireworks Event,
Appomattox River, Hopewell, VA

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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

SUMMARY: The Coast Guard is establishing a 420-foot radius safety zone
on the Appomattox River in the vicinity of Hopewell, VA in support of
the Christmas Holiday Boat Parade Fireworks Event. This action will
protect the maritime public on the Appomattox River from the hazards
associated with fireworks displays.

DATES: This rule is effective from 8 p.m. until 9 p.m. on December 6,
2008.

ADDRESSES: Comments and material received from the public, as well as
documents mentioned in this preamble as being available in the docket,
are part of docket USCG-2008-0838 and are available online by going to
http://www.regulations.gov, selecting the Advanced Docket Search option
on the right side of the screen, inserting USCG-2008-0838 in the Docket
ID box, pressing Enter, and then clicking on the item in the Docket ID
column. This

material is also available for inspection or copying at two locations:
the Docket Management Facility (M-30), U.S. Department of
Transportation, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays and the Sector Hampton
Roads, Norfolk Federal Building, 200 Granby St., 7th Floor, Norfolk, VA
23510 between 9 a.m. and 2 p.m., Monday through Friday, except Federal
holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this
temporary rule, call LT Tiffany Duffy, Chief, Waterways Management
Division, Sector Hampton Roads at<PHONE_NUMBER>. If you have questions
on viewing the docket, call Renee V. Wright, Program Manager, Docket
Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Regulatory Information

    On August 28, 2008, we published a notice of proposed rulemaking
(NPRM) entitled Safety Zone: Christmas Holiday Boat Parade Fireworks
Event, Appomattox River, Hopewell, VA, in the Federal Register (73 FR
168). We received no letters commenting on the proposed rule. No public
meeting was requested, and none was held.

Background and Purpose

    On December 6, 2008, the City of Hopewell, VA will sponsor a
fireworks display on the Appomattox River centered on position
37[deg]19'34'' N/77[deg]16'00'' W (NAD 1983). Due to the need to
protect mariners and spectators from the hazards associated with the
fireworks display, access to the Appomattox River within a 420 foot
radius of the fireworks barge will be temporarily restricted.

Regulatory Analyses

    We developed this rule after considering numerous statutes and
executive orders related to rulemaking. Below we summarize our analyses
based on 13 of these statutes or executive orders.

Regulatory Planning and Review

    This rule is not a significant regulatory action under section 3(f)
of Executive Order 12866, Regulatory Planning and Review, and does not
require an assessment of potential costs and benefits under section
6(a)(3) of that Order. The Office of Management and Budget has not
reviewed it under that Order. Although this regulation restricts access
to the safety zone, the effect of this rule will not be significant
because: (i) The safety zone will be in effect for a limited duration;
(ii) the zone is of limited size; and (iii) the Coast Guard will make
notifications via maritime advisories so mariners can adjust their
plans accordingly.

Small Entities

    Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have
considered whether this rule would have a significant economic impact
on a substantial number of small entities. 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 rule will
not have a significant economic impact on a substantial number of small
entities. However, this rule may affect the following entities, some of
which may be small entities: Owners and operators of vessels intending
to transit or anchor in that portion of the Appomattox River from 8
p.m. to 9 p.m. on December 6, 2008. Although this regulation restricts
access to the safety zone, the effect of this rule will not
significantly impact small entities because: (i) The safety zone will
be in effect for a limited duration; (ii) the zone is of limited size;
and (iii) the Coast Guard will make notifications via maritime
advisories so mariners can adjust their plans accordingly.

Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), in the NPRM we offered to
assist small entities in understanding the rule so that they could
better evaluate its effects on them and participate in the rulemaking
process.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

Collection of Information

    This rule calls for no new collection of information under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

Federalism

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on State or local
governments and would either preempt State law or impose a substantial
direct cost of compliance on them. We have analyzed this rule under
that Order and have determined that it does not have implications for
federalism.

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 or more in any
one year. Though this rule will not result in such an expenditure, we
do discuss the effects of this rule elsewhere in this preamble.

Taking of Private Property

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

Civil Justice Reform

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

Protection of Children

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

Indian Tribal Governments

    This rule does not have tribal implications under Executive Order
13175, Consultation and Coordination with Indian Tribal Governments,
because it does 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.

Energy Effects

    We have analyzed this rule under Executive Order 13211, Actions
Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use. We have determined that it is not a ``significant
energy action'' under that order because it is not a ``significant
regulatory action'' under Executive Order 12866 and is not likely to
have a significant adverse effect on the supply, distribution, or use
of energy. The Administrator of the Office of Information and
Regulatory Affairs has not designated it as a significant energy
action. Therefore, it does not require a Statement of Energy Effects
under Executive Order 13211.

Technical Standards

    The National Technology Transfer and Advancement Act (NTTAA) (15
U.S.C. 272 note) directs agencies to use voluntary consensus standards
in their regulatory activities unless the agency provides Congress,
through the Office of Management and Budget, with an explanation of why
using these standards would be inconsistent with applicable law or
otherwise impractical. Voluntary consensus standards are technical
standards (e.g., specifications of materials, performance, design, or
operation; test methods; sampling procedures; and related management
systems practices) that are developed or adopted by voluntary consensus
standards bodies.
    This rule does not use technical standards. Therefore, we did not
consider the use of voluntary consensus standards.

Environment

    We have analyzed this rule under Department of Homeland Security
Management Directive 5100.1 and Commandant Instruction M16475.lD, which
guide the Coast Guard in complying with the National Environmental
Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have concluded
under the Instruction that there are no factors in this case that would
limit the use of a categorical exclusion under section 2.B.2 of the
Instruction. Therefore, this rule is categorically excluded, under
figure 2-1, paragraph (34)(g), of the Instruction, from further
environmental documentation. An environmental analysis checklist and a
categorical exclusion determination will be available in the docket
where indicated under ADDRESSES.

List of Subjects in 33 CFR Part 165

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

0
For the reasons discussed in the preamble, the Coast Guard amends 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. 1226, 1231; 46 U.S.C. Chapter 701, 3306,
3703; 50 U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1, 6.04-6, 160.5; Pub.
L. 107-295, 116 Stat. 2064; Department of Homeland Security
Delegation No. 0170.1.

0
2. Add Sec.  165.T05-0838, to read as follows:

Sec.  165.T05-0838  Safety Zone: Christmas Holiday Boat Parade
Fireworks Event, Appomattox River, Hopewell, VA.

    (a) Regulated Area. The following area is a safety zone: All
navigable waters of the Captain of the Port Sector Hampton Roads zone,
as defined in 33 CFR 3.25-10, in the vicinity of the Appomattox River
in Hopewell, VA within 420 feet of position 37[deg]19'34'' N/
77[deg]16'00'' W (NAD 1983).
    (b) Definitions. As used in this section, Captain of the Port
Representative means any U.S. Coast Guard commissioned, warrant or
petty officer who has been authorized by the Captain of the Port,
Hampton Roads, Virginia to act on his behalf.
    (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, Hampton Roads or his designated
representatives.
    (2) The operator of any vessel in the immediate vicinity of this
safety zone shall:
    (i) Stop the vessel immediately upon being directed to do so by any
commissioned, warrant or petty officer on shore or on board a vessel
that is displaying a U.S. Coast Guard Ensign.
    (ii) Proceed as directed by any commissioned, warrant or petty
officer on shore or on board a vessel that is displaying a U.S. Coast
Guard Ensign.
    (3) The Captain of the Port, Hampton Roads and the Sector Duty
Officer at Sector Hampton Roads in Portsmouth, Virginia can be
contacted at telephone number<PHONE_NUMBER>.
    (4) The Captain of the Port Representative enforcing the safety
zone can be contacted on VHF-FM marine band radio, channel 13 (156.65
Mhz) and channel 16 (156.8 Mhz).
    (d) Enforcement. The U.S. Coast Guard may be assisted in the patrol
and enforcement of the zone by Federal, State, and local agencies.
    (e) Enforcement Period. This rule will be enforced from 8 p.m. to 9
p.m. on December 6, 2008.

    Dated: October 17, 2008.
Patrick B. Trapp,
Captain, U.S. Coast Guard, Captain of the Port, Hampton Roads.
[FR Doc. E8-26523 Filed 11-5-08; 8:45 am]

BILLING CODE 4910-15-P