[Federal Register: August 21, 2008 (Volume 73, Number 163)]
[Notices]
[Page 49535-49536]
[DOCID:fr21au08-108]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Approval of Noise Compatibility Program; Centennial Airport,
Englewood, CO; FAA

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 Arapahoe
County Public Airport Authority for the Centennial Airport under the
provisions of Title I of the Aviation Safety and Noise Abatement Act of
1979 (Pub. L. 96-193) and 14 CFR Part 150, Airport Noise Compatibility
Planning. These findings are made in recognition of the description of
federal and non-federal responsibilities in Senate Report No. 96-52
(1980). On August 12, 2008, the Airports Division Manager approved the
Centennial Airport noise compatibility program. Of the twelve proposed
program elements, FAA approved eight and reserved approval of another
two measures pending further study. The remaining two measures were
disapproved.

DATES: The effective date of the FANs approval of the Centennial
Airport noise compatibility program is August 12, 2008.

FOR FURTHER INFORMATION CONTACT: Linda Bruce, Federal Aviation
Administration, Denver Airports District Office, 26805 E. 68th Avenue,
Suite 224, Denver, Colorado 80249-6361, Telephone<PHONE_NUMBER>.
Documents reflecting this FAA action may be obtained from Ms. Bruce or
on the Internet at http://www.faa.gov/airports_airtraffic/airports/
regional guidance/northwest-- mountain/environmental/.

SUPPLEMENTARY INFORMATION: This notice announces that the FAA has given
its overall approval to the Centennial Airport noise compatibility
program, effective August 12, 2008. Under Section 104(a) of the
Aviation Safety and Noise Abatement Act of 1979 (hereinafter 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 14 CFR Part 150 is a local program, not a federal program. The FAA
does not substitute its judgment for that of the airport sponsor with
respect to which measures should be recommended for action. The FAA's
approval or disapproval of Part 150 program recommendations is measured
according to the standards expressed in 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 FAR 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 noncompatible 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 as
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 a 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 an environmental assessment 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 under the Airport and Airway Improvement Act of
1982. Where Federal funding is sought, the airport sponsor must submit
requests for project grants to the FAA Denver Airports District Office
in Denver, Colorado.
    The Centennial Airport study contains a proposed noise
compatibility program comprised of actions designed for implementation
by airport management and adjacent jurisdictions from the date of study
completion to beyond the year 2012. The Arapahoe County Public Airport
Authority, Englewood, CO, requested that the FAA evaluate and approve
this material as a noise compatibility program for the Centennial
Airport, as described in Section 104(b) of the Act. The FAA began its
review of the program on February 22, 2008, and was required by a
provision of the Act to approve or disapprove the program within 180
days (other than the use of new flight procedures for noise control).
Failure to approve or disapprove such a program within the 180-day
period shall be deemed to be an approval of such a program.
    The submitted program contained 12 proposed actions to address
noise on and off the airport. The FAA completed its review and
determined that the overall program complied with procedural and
substantive requirements of the Act and Part 150. The overall program,
therefore, was approved by FAA effective August 12, 2008. Outright
approval was granted for eight of the specific program elements. One of
these elements proposes the ban of Stage I aircraft from operating at
Centennial Airport. Since there is no Federal preemption to banning
such aircraft, FAA approved this element. Two other elements proposed
involve voluntary measures that the airport sponsor can encourage
pilots to use to help minimize aircraft noise.
    The only land use planning element proposed by the airport sponsor
was approved by FAA. This element involves the airport authority
working with the local municipalities to amend zoning requirements,
comprehensive plans and development regulations to minimize new, non-
compatible land uses near the airport and to minimize the impact on
airspace surrounding the airport, including 14 CFR Part 77 imaginary
surfaces.
    The remaining approved elements involve program management and are
intended to assist in the development and operations of a noise
abatement office and noise monitoring efforts. These measures include
the installation of permanent noise monitoring system to monitor noise
levels and compliance with noise abatement measures and the use of a
public advisory committee to

monitor programs implemented as a result on the adoption of the NCP,
including the Fly Quiet Program guidelines and the Noise Monitoring
Program.
    The airport sponsor proposed three changes to flight procedures.
One of these measures, a change to nighttime flight procedures for jets
departing to the north, will require further safety and environmental
analysis. The other two programs elements FAA disapproved as they
involve proposed changes to flight paths that FAA Air Traffic Control
determined would create numerous adverse impacts to safety and
efficiency of air traffic control operations. These program elements
propose testing 24-hour flight tracks between 350 and 010 degree
headings and implementing a 170 degree departure heading to 4 DME or
8,000 MSL (+/-20 degrees).
    FAA disapproved the remaining program element, the proposed ban of
Stage 2 aircraft under 75,000 lbs. from operating at Centennial Airport
at nighttime, pending further study. Per the requirements of 14 CFR
Part 16, this measure requires further study to determine the impact on
the national airspace system and air commerce.
    FAA's determinations are set forth in detail in a Record of
Approval endorsed by the Airports Division Manager on August 12, 2008.
The Record of Approval, as well as other evaluation materials and the
documents comprising the submittal, are available for review at the FAA
office and Internet site listed above and at the administrative offices
of the Arapahoe County Public Airport Authority, Englewood, CO.

    Issued in Renton, Washington on August 12, 2008.
Donna Taylor,
Manager, Airports Division, FAA Northwest Mountain Region.
[FR Doc. E8-19278 Filed 8-20-08; 8:45 am]

BILLING CODE 4910-13-M


[Federal Register Volume 80, Number 80 (Monday, April 27, 2015)]
[Notices]
[Page 23265]
[FR Doc No: 2015-09691]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RC15-1-000]

Southern California Edison Company; Notice of Filing

    Take notice that on April 16, 2015, Southern California Edison
Company filed an application requesting the Federal Energy Regulatory
Commission (Commission) to make a determination that certain 115 kV
facilities are used in local distribution and are not part of the bulk
electric system.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date. On or
before the comment date, it is not necessary to serve motions to
intervene or protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov. Persons unable to file electronically should submit an
original and 5 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive 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>.
    Comment Date: 5:00 p.m. Eastern Time on May 18, 2015.

    Dated: April 20, 2015.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2015-09691 Filed 4-24-15; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 85, Number 132 (Thursday, July 9, 2020)]
[Rules and Regulations]
[Pages 41184-41186]
[FR Doc No: 2020-14475]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2020-0049; Airspace Docket No. 19-AEA-11]
RIN 2120-AA66

Revocation and Amendment of Multiple Air Traffic Service (ATS)
Routes in the Vicinity of Bradford, PA, and Wellsville, NY

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: This action amends VHF Omnidirectional Range (VOR) Federal
airways V-33, V-116, V-119, V-126, V-164, V-170, V-265, V-270, and V-
501 in the vicinity of Bradford, PA, and Wellsville, NY. The VOR
Federal airway modifications are necessary due to the planned
decommissioning of the VOR portions of the Bradford, PA, VOR/Distance
Measuring Equipment (VOR/DME) and the Wellsville, NY, VOR/Tactical Air
Navigation (VORTAC) navigation aids (NAVAIDs). The NAVAIDs provide
navigation guidance for portions of the affected airways. These VORs
are being decommissioned as part of the FAA's VOR Minimum Operational
Network (MON) program.

DATES: Effective date 0901 UTC, September 10, 2020. 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 7400.11 and publication of conforming amendments.

ADDRESSES: FAA Order 7400.11D, Airspace Designations and Reporting
Points, and subsequent amendments can be viewed online at https://www.faa.gov/air_traffic/publications/. For further information, you can
contact the Rules and Regulations Group, Federal Aviation
Administration, 800 Independence Avenue SW, Washington, DC 20591;
telephone:<PHONE_NUMBER>. The Order is also available for inspection
at the National Archives and Records Administration (NARA). For
information on the availability of FAA Order 7400.11D at NARA, email:
<EMAIL_ADDRESS>or go to https://www.archives.gov/federal-register/cfr/ibr-locations.html.

FOR FURTHER INFORMATION CONTACT: Colby Abbott, Rules and Regulations
Group, Office of Policy, Federal Aviation Administration, 800
Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-
8783.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. Subtitle I, 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
the 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 modifies the route structure as necessary to preserve
the safe and efficient flow of air traffic within the National Airspace
System.

History

    The FAA published a notice of proposed rulemaking (NPRM) for Docket
No. FAA-2020-0049 in the Federal Register (85 FR 6115; February 4,
2020), amending VOR Federal airways V-33, V-116, V-119, V-126, V-164,
V-170, V-265, V-270, and V-501 in the vicinity of Bradford, PA, and
Wellsville, NY, due to the planned decommissioning of the VOR portions
of the Bradford, PA, VOR/DME and the Wellsville, NY, VORTAC. Interested
parties were invited to participate in this rulemaking effort by
submitting written comments on the proposal. No comments were received.
    Subsequent to the NPRM, the FAA published a rule for Docket No.
FAA-2020-0007 in the Federal Register (85 FR 38783; June 29, 2020),
amending VOR Federal airway V-119 by removing the airway segment
overlying the Newcombe, KY, VORTAC between the Newcombe, KY, VORTAC and
the Henderson, WV, VORTAC. That airway amendment, effective September
10, 2020, is included in this rule.
    VOR Federal airways are published in paragraph 6010(a) of FAA Order
7400.11D dated August 8, 2019, and effective September 15, 2019, which
is incorporated by reference in 14 CFR 71.1. The VOR Federal airways
listed in this document will be subsequently published in the Order.

Availability and Summary of Documents for Incorporation by Reference

    This document amends FAA Order 7400.11D, Airspace Designations and
Reporting Points, dated August 8, 2019, and effective September 15,
2019. FAA Order 7400.11D is publicly available as listed in the
ADDRESSES section of this document. FAA Order 7400.11D lists Class A,
B, C, D, and E airspace areas, air traffic service routes, and
reporting points.

Differences From the Proposal

    In the NPRM, the description of VOR Federal airway V-33 contained
in the Proposal section included the exclusionary language, ``The
airspace within R-4007A and R-4007B [restricted areas] is excluded.''
That exclusion language in the airway description has been unchanged
since the exclusion language was added to the V-33 description in 1980
(45 FR 77418; November 24, 1980). However, R-4007A was re-designated R-
4007 in 1997 and R-4007B expired in 1983. The correct restricted area
reference for the exclusion language is ``R-4007''.
    On September 7, 1978, the FAA re-designated restricted area R-4007
as R-4007A, and temporarily established a new restricted area, R-4007B,
directly above it (43 FR 28813; July 3, 1978). The purpose of R-4007B
was to provide additional airspace to accommodate fighter development
testing. The R-4007B designation expired on January 1, 1983. However,
R-4007A was not renumbered at that time due to the possibility of
future rulemaking action to re-establish the ``B'' area to contain
other flight test projects.
    Based on forecast requirements at the Patuxent River test facility,
the U.S. Navy determined that there was no future need for R-4007B and
requested the FAA re-designate R-4007A as R-4007. On February 26, 1998,
the FAA re-designated restricted area R-4007A as R-4007 (62 FR 65359;
December 12, 1997).
    Therefore, this rule changes the restricted area references in the
V-33 exclusion language from ``R-4007A and R-4007B'' to ``R-4007''.

The Rule

    The FAA is amending Title 14 Code of Federal Regulations (14 CFR)
part 71 by modifying VOR Federal airways V-33, V-116, V-119, V-126, V-
164, V-170, V-265, V-270, and V-501. The planned decommissioning of the
VOR portion of the Bradford, PA, VOR/DME and Wellsville, NY, VORTAC
NAVAIDs have made this action necessary. The

VOR Federal airway changes are outlined below.
    V-33: V-33 extends between the Harcum, VA, VORTAC and the
Nottingham, MD, VORTAC; and between the Baltimore, MD, VORTAC and the
Buffalo, NY, VOR/DME. The airspace within R-4007 is excluded. The
airway segment overlying the Bradford, PA, VOR/DME between the Keating,
PA, VORTAC and the Buffalo, NY, VOR/DME is removed. The unaffected
portions of the existing airway remain as charted.
    V-116: V-116 extends between the Erie, PA, VORTAC and the Sparta,
NJ, VOR/DME. The airway segment overlying the Bradford, PA, VOR/DME
between the Erie, PA, VORTAC and the Stonyfork, PA, VOR/DME is removed.
The unaffected portions of the existing airway remain as charted.
    V-119: V-119 extends between the Henderson, WV, VORTAC and the
Rochester, NY, VOR/DME. The airway segment overlying the Bradford, PA,
VOR/DME and the Wellsville, NY, VORTAC between the Clarion, PA, VORTAC
and the Rochester, NY, VORTAC is removed. The unaffected portions of
the existing airway would remain as charted.
    V-126: V-126 extends between the intersection of the Peotone, IL,
VORTAC 053[deg] and Knox, IN, VOR/DME 297[deg] radials and the
intersection of the Goshen, IN, VORTAC 092[deg] and Fort Wayne, IN,
VORTAC 016[deg] radials; and between the Erie, PA, VORTAC and the
Stonyfork, PA, VOR/DME. The airway segment overlying the Wellsville,
NY, VORTAC between the Erie, PA, VORTAC and the Stonyfork, PA, VOR/DME
is removed. The unaffected portions of the existing airway remain as
charted.
    V-164: V-164 extends between the Buffalo, NY, VOR/DME and the East
Texas, PA, VOR/DME. The airway segment overlying the Wellsville, NY,
VORTAC between the Buffalo, NY, VOR/DME and the Stonyfork, PA, VOR/DME
is removed. The unaffected portions of the existing airway remain as
charted.
    V-170: V-170 extends between the Devils Lake, ND, VOR/DME and the
Worthington, MN, VOR/DME; between the Rochester, MN, VOR/DME and the
Salem, MI, VORTAC; and between the Bradford, PA, VOR/DME and the
intersection of the Andrews, MD, VORTAC 060[deg] and Baltimore, MD,
VORTAC 165[deg] radials. The airspace within restricted area R-5802 is
excluded when the restricted area is active. The airway segment
overlying the Bradford, PA, VOR/DME between the Bradford, PA, VOR/DME
and the Slate Run, PA, VORTAC is removed. The unaffected portions of
the existing airway remain as charted.
    V-265: V-265 extends between the intersection of the Washington,
DC, VOR/DME 043[deg] and Westminster, MD, VORTAC 179[deg] radials and
the Jamestown, NY, VOR/DME. The airway segment overlying the Bradford,
PA, VORTAC between the Keating, PA, VORTAC and the Jamestown, NY, VOR/
DME is removed. Additionally, an editorial correction changes the state
abbreviation for the Keating VORTAC to ``PA''. The unaffected portions
of the existing airway remain as charted.
    V-270: V-270 extends between the Erie, PA, VORTAC and the Boston,
MA, VOR/DME. The airway segment overlying the Wellsville, NY, VORTAC
between the Jamestown, NY, VOR/DME and the Elmira, NY, VOR/DME is
removed. The unaffected portions of the existing airway remain as
charted.
    V-501: V-501 extends between the Martinsburg, WV, VORTAC and the
Philipsburg, PA, VORTAC; and between the Wellsville, NY, VORTAC and the
intersection of the Wellsville, NY, VORTAC 045[deg] and Geneseo, NY,
VOR/DME 091[deg] radials. The airway segment overlying the Wellsville,
NY, VORTAC between the Wellsville, NY, VORTAC and the intersection of
the Wellsville, NY, VORTAC 045[deg] and Geneseo, NY, VOR/DME 091[deg]
radials is removed. The unaffected portions of the existing airway
remain as charted.
    All NAVAID radials listed in the VOR Federal airway descriptions
below are unchanged and stated in True degrees.
    FAA Order 7400.11, Airspace Designations and Reporting Points, is
published yearly and effective on September 15.

Regulatory Notices and Analyses

    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.
It, therefore: (1) Is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under
Department of Transportation (DOT) Regulatory Policies and Procedures
(44 FR 11034; February 26, 1979); and (3) does not warrant preparation
of a regulatory evaluation as the anticipated impact is so minimal.
Since this is a routine matter that will only affect air traffic
procedures and air navigation, it is certified that this rule, when
promulgated, will not have a significant economic impact on a
substantial number of small entities under the criteria of the
Regulatory Flexibility Act.

Environmental Review

    The FAA has determined that this action of modifying VOR Federal
airways V-33, V-116, V-119, V-126, V-164, V-170, V-265, V-270, and V-
501, due to the planned decommissioning of the VOR portion of the
Bradford, PA, VOR/DME and Wellsville, NY, VORTAC NAVAIDs, qualifies for
categorical exclusion under the National Environmental Policy Act and
its implementing regulations at 40 CFR part 1500, and in accordance
with FAA Order 1050.1F, Environmental Impacts: Policies and Procedures,
paragraph 5-6.5a, which categorically excludes from further
environmental impact review rulemaking actions that designate or modify
classes of airspace areas, airways, routes, and reporting points (see
14 CFR part 71, Designation of Class A, B, C, D, and E Airspace Areas;
Air Traffic Service Routes; and Reporting Points). As such, this action
is not expected to result in any potentially significant environmental
impacts. In accordance with FAA Order 1050.1F, paragraph 5-2 regarding
Extraordinary Circumstances, the FAA has reviewed this action for
factors and circumstances in which a normally categorically excluded
action may have a significant environmental impact requiring further
analysis. The FAA has determined that no extraordinary circumstances
exist that warrant preparation of an environmental assessment or
environmental impact study.

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 7400.11D,
Airspace Designations and Reporting Points, dated August 8, 2019 and
effective September 15, 2019, is amended as follows:

Paragraph 6010(a) Domestic VOR Federal Airways.

* * * * *

V-33 [Amended]

    From Harcum, VA; INT Harcum 003[deg] and Nottingham, MD,
174[deg] radials; to Nottingham. From Baltimore, MD; INT Baltimore
004[deg] and Harrisburg, PA, 147[deg] radials; Harrisburg;
Philipsburg, PA; to Keating, PA. The airspace within R-4007 is
excluded.
* * * * *

V-116 [Amended]

    From Stonyfork, PA; INT Stonyfork 098[deg] and Wilkes-Barre, PA,
310[deg] radials; Wilkes-Barre; INT Wilkes-Barre 084[deg] and
Sparta, NJ, 300[deg] radials; to Sparta.
* * * * *

V-119 [Amended]

    From Henderson, WV; Parkersburg, WV; INT Parkersburg 067[deg]
and Indian Head, PA, 254[deg] radials; Indian Head; to Clarion, PA.
* * * * *

V-126 [Amended]

    From INT Peotone, IL, 053[deg] and Knox, IN, 297[deg] radials;
INT Knox 297[deg] and Goshen, IN, 270[deg] radials; Goshen; to INT
Goshen 092[deg] and Fort Wayne, IN, 016[deg] radials.
* * * * *

V-164 [Amended]

    From Stonyfork, PA; Williamsport, PA; INT Williamsport 129[deg]
and East Texas, PA, 315[deg] radials; to East Texas.
* * * * *

V-170 [Amended]

    From Devils Lake, ND; INT Devils Lake 187[deg] and Jamestown,
ND, 337[deg] radials; Jamestown; Aberdeen, SD; Sioux Falls, SD; to
Worthington, MN. From Rochester, MN; Nodine, MN; Dells, WI; INT
Dells 097[deg] and Badger, WI, 304[deg] radials; Badger; INT Badger
121[deg] and Pullman, MI, 282[deg] radials; Pullman; to Salem, MI.
From Slate Run, PA; Selinsgrove, PA; Ravine, PA; INT Ravine 125[deg]
and Modena, PA, 318[deg] radials; Modena; Dupont, DE; INT Dupont
223[deg] and Andrews, MD, 060[deg] radials; to INT Andrews 060[deg]
and Baltimore, MD, 165[deg] radials. The airspace within R-5802 is
excluded when active.
* * * * *

V-265 [Amended]

    From INT Washington, DC, 043[deg] and Westminster, MD, 179[deg]
radials; Westminster; Harrisburg, PA; Philipsburg, PA; to Keating,
PA.
* * * * *

V-270 [Amended]

    From Erie, PA; to Jamestown, NY. From Elmira, NY; Binghamton,
NY; DeLancey, NY; Chester, MA; INT Chester 091[deg] and Boston, MA,
262[deg] radials; to Boston.
* * * * *

V-501 [Amended]

    From Martinsburg, WV; Hagerstown, MD; St Thomas, PA; to
Philipsburg, PA.
* * * * *

    Issued in Washington, DC, on July 2, 2020.
Scott M. Rosenbloom,
Acting Manager, Rules and Regulations Group.
[FR Doc. 2020-14475 Filed 7-8-20; 8:45 am]
BILLING CODE 4910-13-P


 ENVIRONMENTAL PROTECTION AGENCY
 40 CFR Part 93
 EPA-HQ-OAR-2011-0393; FRL_XXXX-X
 RIN 2060-AR03
 Transportation Conformity Rule:  MOVES Regional Grace Period Extension
 AGENCY:  Environmental Protection Agency (EPA).
 ACTION:  Direct final rule.
 SUMMARY:  EPA is taking direct final action to extend the grace period before the MOtor Vehicle Emission Simulator model (currently MOVES2010a) is required for regional emissions analyses for transportation conformity determinations ("regional conformity analyses").  This final rule provides an additional year to the previously established two-year conformity grace period.  As a result, EPA is announcing in this Federal Register that MOVES is not required for regional conformity analyses until March 2, 2013.  This action does not affect EPA's previous approval of the use of MOVES in official state air quality implementation plan (SIP) submissions or the existing grace period before MOVES2010a is required for carbon monoxide and particulate matter hot-spot analyses for project-level conformity determinations.
 DATES:  This rule is effective on [insert date 60 days from date of publication in the Federal Register] without further notice, unless EPA receives adverse comment by [insert date 30 days from date of publication in the Federal Register].  If EPA receives adverse comment, we will publish a timely withdrawal in the Federal Register informing the public that the rule will not take effect.
 ADDRESSES:  Submit any comments to Docket ID No. EPA-OAR-2011-0393, by one of the following methods:
   * www.regulations.gov: Follow the on-line instructions for submitting comments.
   * Email<EMAIL_ADDRESS>   * Fax:<PHONE_NUMBER>
   * Mail: Air Docket, Environmental Protection Agency, Mailcode: 2822T, 1200 Pennsylvania Ave., NW, Washington, D.C., 20460, Attention Docket ID No. EPA-HQ-OAR-2011-0393.  Please include a total of two copies.
   * Hand Delivery:  Air Docket, Environmental Protection Agency:  EPA West Building, EPA Docket Center (Room 3334), 1301 Constitution Ave., NW, Washington, D.C., Attention Docket ID No. EPA-HQ-OAR-2011-0393.  Please include two copies.  Such deliveries are only accepted during the Docket's normal hours of operation, and special arrangements should be made for deliveries of boxed information.
 Instructions:  Direct your comments to Docket ID No. EPA-HQ-OAR-2011-0393.  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 information that you consider to be CBI or otherwise protected through www.regulations.gov or e-mail.  The www.regulations.gov website 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 e-mail comment directly to EPA without going through www.regulations.gov, your e-mail 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:  www.epa.gov/epahome/dockets.htm.  For additional instructions on submitting comments, go to the SUPPLEMENTARY INFORMATION section of this document.
Docket:  All documents in the docket are listed in the www.regulations.gov index.  Although listed in the index, some information is not publicly available, e.g., CBI or other information whose disclosure is restricted by statute.  Certain other material, such as copyrighted material, will be publicly available only in hard copy.  Publicly available docket materials are available either electronically in www.regulations.gov or in hard copy at the Air and Radiation Docket, EPA/DC, EPA West, Room 3334, 1301 Constitution Ave., NW, Washington, DC.  The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays.  The telephone number for the Public Reading Room is<PHONE_NUMBER> and the telephone number for the Air and Radiation Docket is<PHONE_NUMBER>.
 FOR FURTHER INFORMATION CONTACT:  Meg Patulski, State Measures and Conformity Group, Transportation and Regional Programs Division, Environmental Protection Agency, 2000 Traverwood Drive, Ann Arbor, MI 48105; telephone number:<PHONE_NUMBER>; fax number:<PHONE_NUMBER>; email address<EMAIL_ADDRESS>or Astrid Larsen, State Measures and Conformity Group, Transportation and Regional Programs Division, Environmental Protection Agency, 2000 Traverwood Drive, Ann Arbor, MI 48105; telephone number:<PHONE_NUMBER>; fax number:<PHONE_NUMBER>; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:
The content of this preamble is listed in the following outline:
I. General Information
II. Background
III. Extension of MOVES2010a Regional Conformity Grace Period
IV. Conformity SIPs
V. Statutory and Executive Order Reviews
If this rule becomes effective, the conformity grace period in applicable areas will end on March 2, 2013, after which MOVES2010a is required to be used for new regional conformity analyses.
Availability of MOVES2010a and Support Materials
Copies of the official version of the MOVES2010a motor vehicle emissions model, along with user guides and supporting documentation, are available on EPA's MOVES website: www.epa.gov/otaq/models/moves/index.htm.
Guidance on how to apply MOVES2010a for SIPs and transportation conformity purposes, including "Policy Guidance on the Use of MOVES2010 for State Implementation Plan Development, Transportation Conformity, and Other Purposes" (EPA-420-B-09-046, December 2009) and "Technical Guidance on the Use of MOVES2010 for Emission Inventory Preparation in State Implementation Plans and Transportation Conformity" (EPA-420-B-10-023, April 2010) can be found on the EPA's transportation conformity website at: www.epa.gov/otaq/stateresources/transconf/policy.htm.
   I.       General Information
A.   Why Is EPA Using a Direct Final Rule?
	EPA is publishing this rule without a prior proposed rule because we view this as a noncontroversial action and anticipate no adverse comment.  This rule makes a one-time, minor revision to the transportation conformity rule to provide administrative relief requested by state and local agencies for certain nonattainment and maintenance areas.  There are significant technical differences between MOVES2010a and the previous emissions model, and affected state and local agencies require additional time to make the conformity transition to MOVES2010a successfully.  However, in the "Proposed Rules" section of today's Federal Register, we are publishing a separate document that will serve as the proposed rule to extend the MOVES2010a regional conformity grace period if adverse comments are received on this direct final rule.  We will not institute a second comment period on this action.  Any parties interested in commenting must do so at this time.  For further information about commenting on this rule, see the ADDRESSES section of this document.
      If EPA receives adverse comment, we would publish a timely withdrawal in the Federal Register informing the public that this direct final rule will not take effect.  We would address all public comments in any subsequent final rule based on the proposed rule.
 B. 	Does This Action Apply to Me?
       Entities potentially regulated by the transportation conformity rule are those that adopt, approve, or fund transportation plans, transportation improvement programs (TIPs), or projects under title 23 U.S.C. or title 49 U.S.C. Chapter 53.  Regulated categories and entities affected by today's action include:
 Category
 Examples of regulated entities
 Local government
 Local transportation and air quality agencies, including metropolitan planning organizations (MPOs).
 State government
 State transportation and air quality agencies.
 Federal government
 Department of Transportation (Federal Highway Administration (FHWA) and Federal Transit Administration (FTA)).

 	This table is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this direct final rule.  This table lists the types of entities of which EPA is aware that potentially could be regulated by the transportation conformity rule.  Other types of entities not listed in the table could also be regulated.  To determine whether your organization is regulated by this action, you should carefully examine the applicability requirements in 40 CFR 93.102.  If you have questions regarding the applicability of this action to a particular entity, consult the persons listed in the preceding FOR FURTHER INFORMATION CONTACT section.
 C.	What Should I Consider as I Prepare Any Comments for EPA?
1.	Submitting CBI
	Do not submit this information to EPA through www.regulations.gov or e-mail.  Clearly mark the part or all of the information that you claim to be CBI.  For CBI information in a disk or CD-ROM that you mail to EPA, mark the outside of the disk or CD- ROM as CBI and then identify electronically within the disk or CD-ROM the specific information that is claimed as CBI.  In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket.  Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR Part 2.
2.	Tips for Preparing Your Comments
	When submitting comments, remember to:
   * Identify the rulemaking by docket number and other identifying information (subject heading, Federal Register date and page number).
   * Follow directions - The Agency may ask you to respond to specific questions or organize comments by referencing a Code of Federal Regulations (CFR) part or section number.
   * Explain why you agree or disagree, suggest alternatives and substitute language for your requested changes.
   * Describe any assumptions and provide any technical information and/or data that you used.
   * If you estimate potential costs or burdens, explain how you arrived at your estimate in sufficient detail to allow for it to be reproduced.
   * Provide specific examples to illustrate your concerns, and suggest alternatives.
   * Explain your views as clearly as possible, avoiding the use of profanity or personal threats.
   * Make sure to submit your comments by the comment period deadline identified.
3.	Docket Copying Costs
 	You may be required to pay a reasonable fee for copying docket materials.
 D.	How Do I Get Copies of This Direct Final Rule and Other Documents?
 1.	Docket
 	EPA has established an official public docket for this action under Docket ID No. EPA-HQ-OAR-2011-0393.  You can get a paper copy of this Federal Register document, as well as the documents specifically referenced in this action, any public comments received, and other information related to this action at the official public docket.  See the ADDRESSES section for its location.
 2.	Electronic Access
 	You may access this Federal Register document electronically through EPA's transportation conformity website at:  www.epa.gov/otaq/stateresources/transconf/index.htm.  You may also access this document electronically under the Federal Register listings at:  www.epa.gov/fedrgstr/.
 	An electronic version of the official public docket is available through www.regulations.gov.  You may use www.regulations.gov to submit or view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically.  Once in the system, select "search," then key in the appropriate docket identification number.
 	Certain types of information will not be placed in the electronic public docket.  Information claimed as CBI and other information for which disclosure is restricted by statute is not available for public viewing in the electronic public docket.  EPA's policy is that copyrighted material will not be placed in the electronic public docket but will be available only in printed, paper form in the official public docket.
       To the extent feasible, publicly available docket materials will be made available in the electronic public docket.  When a document is selected from the index list in EPA Dockets, the system will identify whether the document is available for viewing in the electronic public docket.  Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in the ADDRESSES section.  EPA intends to provide electronic access in the future to all of the publicly available docket materials through the electronic public docket.
 	Public comments submitted on computer disks that are mailed or delivered to the docket will be transferred to the electronic public docket.  Public comments that are mailed or delivered to the docket will be scanned and placed in the electronic public docket.  Where practical, physical objects will be photographed, and the photograph will be placed in the electronic public docket along with a brief description written by the docket staff.
	For additional information about the electronic public docket, visit the EPA Docket Center homepage at:   www.epa.gov/epahome/dockets.htm.
II.	Background
A.	What Is Transportation Conformity?
       Transportation conformity is required under Clean Air Act (CAA) section 176(c) (42 U.S.C. 7506(c)) to ensure that transportation plans, transportation improvement programs (TIPs), and federally supported highway and transit projects are consistent with the purpose of the SIP.  Conformity to the purpose of the SIP means that transportation activities will not cause or contribute to new air quality violations, worsen existing violations, or delay timely attainment of the relevant national ambient air quality standard (NAAQS) or required interim milestones.
       Transportation conformity (hereafter, "conformity") applies to areas that are designated nonattainment, and those areas redesignated to attainment after 1990 ("maintenance areas") for transportation-related criteria pollutants:  ozone, particulate matter (PM2.5 and PM10), carbon monoxide (CO), and nitrogen dioxide (NO2).  EPA's conformity rule (40 CFR Parts 51 and 93) establishes the criteria and procedures for determining whether transportation activities conform to the SIP.  EPA first promulgated the conformity rule on November 24, 1993 (58 FR 62188) and subsequently published several other amendments.  The Department of Transportation (DOT) is EPA's federal partner in implementing the conformity regulation.  EPA has coordinated with DOT, and they concur with this direct final rule.
 B.	What Is MOVES2010a, and How Has It Been Implemented to Date?
The MOtor Vehicle Emission Simulator model (MOVES) is EPA's state-of-the-art model for estimating emissions from highway vehicles, based on analyses of millions of emission test results and considerable advances in the Agency's understanding of vehicle emissions.  MOVES is currently EPA's official emissions model for state and local agencies to estimate volatile organic compounds (VOCs), nitrogen oxides (NOx), PM, CO, and other precursors from cars, trucks, buses, and motorcycles for SIP purposes and conformity determinations outside of California.  MOVES' database-centered design allows EPA to update emissions data more frequently and allows users much greater flexibility in organizing input and output data.
      MOVES2010a is the latest official version of MOVES that EPA has approved for SIP and conformity purposes.  EPA originally announced the release of MOVES2010 in the Federal Register on March 2, 2010 (75 FR 9411) and subsequently released MOVES2010a on September 8, 2010.  MOVES2010a includes minor revisions that enhance model performance and do not significantly affect criteria pollutant emissions results.  Since these are minor revisions to MOVES2010, MOVES2010a is not considered a "new model" under section 93.111 of the conformity rule, as described further below.
      MOVES2010a is a significant improvement over the previous emissions model, MOBILE6.2, in terms of quality of results and overall functionality.  It incorporates the latest emissions data, more sophisticated calculation algorithms, increased user flexibility, new software design, and significant new capabilities.  While these changes improve the quality of on-road mobile source inventories, the overall degree of change in the model's function  also adds to the start-up time required for the transition from MOBILE6.2 to MOVES2010a.
      EPA developed MOVES as a completely new model.  Whereas MOBILE6.2 was written in FORTRAN and used simple text files for data input and output, MOVES2010a is written in JAVA and uses a relational database structure in MYSQL to handle input and output as data tables.  These changes make MOVES more flexible, and the analysis of new data incorporated within MOVES will enhance state and local agency understanding of how on-road mobile sources contribute to emissions inventories and the relative effectiveness of various control strategies.  However, this new model framework has created a significant learning curve for state and local agency staff that are required to use MOVES.
      In addition to the challenges of learning new software, state and local agencies also have to make substantial changes in the processes they have developed to create model input and apply model output.  While there were incremental changes between each previous version of the MOBILE model, the basic input and output structure of that model was essentially unchanged since the early 1980s.  Over time, state and local agencies developed their own methods for incorporating local inputs in MOBILE format and for post-processing MOBILE results for inventory development and air quality modeling.  To help state and local agencies with this part of the current transition, EPA created a number of tools that take input data formatted for MOBILE6.2 and convert that data for use in MOVES2010a.
      EPA anticipated many of these challenges when it released MOVES. In order to assist in this model transition, EPA and DOT have already provided hands-on MOVES training in many states.  Additional MOVES training for regional inventories has been requested, and will continue to be offered for the foreseeable future.  EPA continues to provide other technical assistance to state and local agencies via on-going conference calls with user groups, e-mail and phone support, a frequently asked questions web page, and web-based presentations.  All of these efforts are helping state and local agencies make the transition to MOVES2010a, and many agencies are making significant progress in applying the model for official purposes.  However, other state and local agencies are still developing the technical capacity to use MOVES2010a, and need more time to transition for future conformity determinations.
C.	Why Is EPA Conducting This Rulemaking?
      Today's action provides additional time that is critical for nonattainment and maintenance areas to learn and apply MOVES2010a for regional conformity analyses.  EPA has been contacted by several state and local transportation and air quality agencies and associations that are concerned that there has not been sufficient transition time for using MOVES2010a in regional conformity analyses.  These concerns revolve around the time needed to build technical capacity for using MOVES2010a as well as completing necessary SIP and/or transportation plan/TIP changes to assure conformity in the future.  Further details on today's action are provided below.
      Today's action does not affect EPA's previous approval of MOVES2010a for official SIP submissions developed outside of California.  Today's rulemaking also does not affect the existing grace period before MOVES2010a is required for PM2.5, PM10, and CO hot-spot analyses for project-level conformity determinations (75 FR 79370).  EPA coordinated closely with DOT in developing today's action, and DOT concurs on this direct final rule.
III.	Extension of MOVES2010a Regional Conformity Grace Period
   A.       Background
CAA section 176(c)(1) states that "...[t]he determination of conformity shall be based on the most recent estimates of emissions, and such estimates shall be determined from the most recent population, employment, travel, and congestion estimates...."  To meet this requirement, section 93.111 of the conformity rule requires that conformity determinations be based on the latest motor vehicle emissions model approved by EPA.  When EPA approves a new emissions model, EPA consults with DOT to establish a grace period before the model is required for conformity analyses (40 CFR 93.111(b)).  EPA must consider many factors when establishing a grace period for conformity determinations (40 CFR 93.111(b)(2)):
      "The length of the grace period will depend on the degree of change in the model and the scope of re-planning likely to be necessary for MPOs in order to assure conformity."
The conformity rule provides for a grace period for new emissions models of between three and 24 months (40 CFR 93.111(b)(1)).
In the preamble to the original 1993 conformity rule, EPA articulated its intentions for establishing the length of conformity grace period for a new emissions model (58 FR 62211):
         "EPA and DOT will consider extending the grace period if the effects of the new emissions model are so significant that previous SIP demonstrations of what emission levels are consistent with attainment would be substantially affected.  In such cases, states should have an opportunity to revise their SIPs before MPOs must use the model's new emissions factors.  EPA encourages all agencies to inform EPA of the impacts of new emissions models in their area, and EPA may pause to seek such input before determining the length of the grace period."
Section 93.111 conformity requirements have not changed since 1993, and have been implemented successfully for many previous model transitions.
      On March 2, 2010, EPA announced the official release of MOVES2010 and established a two-year grace period before this model was required for new regional conformity analyses (75 FR 9411).  Although the original grace period was established for MOVES2010, EPA clarified in September 2010 that the same grace period for regional conformity analyses also applies to MOVES2010a.  EPA based its decision to establish a two-year conformity grace period on the factors under section 93.111(b)(2), and advised areas to use the interagency consultation process to examine the impact of using MOVES in their future regional conformity analyses.
      Without further EPA action, MOVES2010a would be required for regional conformity analyses that begin after March 2, 2012.  As discussed further in today's action, the special circumstances of the transition from MOBILE to MOVES2010a require a reevaluation of the length of this conformity grace period.
B.	Description of Direct Final Rule
       In today's action, EPA is providing an additional year before MOVES2010a is required for regional conformity analyses.  As a result, EPA is also announcing in today's Federal Register that MOVES2010a  will be required for new regional conformity analyses that begin after March 2, 2013.  State and local agencies outside California can use MOVES2010a for regional conformity analyses earlier than March 2, 2013, if desired, and would be required to do so under limited circumstances such as after MOVES2010a SIP motor vehicle emissions budgets have been found adequate or approved for conformity purposes.
       Today's action adds a new paragraph (b)(3) to section 93.111 of the conformity rule.  Today's final rule applies to MOVES2010a and any future minor revisions to this model that EPA releases before March 2, 2013.  Such minor revisions will not start a new grace period for regional conformity analyses and could include performance enhancements that reduce MOVES run time or model improvements to reduce errors in operating the model.  Any major model updates would be evaluated separately as a "new model" under conformity rule section 93.111.
Between now and the end of the extended conformity grace period (March 2, 2013), areas should use the interagency consultation process to examine how MOVES2010a will impact their future MPO transportation plan/TIP conformity determinations.  Isolated rural areas should also consider the impact of using MOVES2010a on future regional conformity analyses.  Agencies should carefully consider whether the SIP and its motor vehicle emissions budgets should be revised with MOVES2010a or if transportation plans and TIPs should be revised before the end of the conformity grace period, since doing so may be necessary to ensure conformity in the future.
      In general, regional conformity analyses that are started during the grace period can use either MOBILE6.2 or MOVES2010a.  When the grace period ends on March 2, 2013, MOVES2010a will become the only approved motor vehicle emissions model for regional conformity analyses outside California.  This means that all new regional conformity analyses started after the end of the grace period must be based on MOVES2010a, even if the SIP is based on MOBILE6.2 or earlier versions of MOBILE.
       If you have questions about which model should be used in your conformity determination, you can consult with your EPA Regional Office.  For complete explanations of how MOVES2010a is to be implemented for transportation conformity, including details about using MOVES2010a during the grace period, refer to EPA's existing MOVES policy guidance.
C.	Rationale
      MOVES2010a is EPA's best tool for estimating criteria pollutant emissions, and it is a significant improvement over previous MOBILE models.  State and local agencies have made significant progress to date in using MOVES2010a, and EPA supports these efforts and encourages that they continue.  However, as discussed above, challenges related to start-up and model application have been much greater in the transition to MOVES2010a, compared to past transitions between MOBILE model versions.  As a result, EPA has determined that a one-year extension of the MOVES2010a grace period is necessary for state and local agencies to complete the current transition.  Today's action ensures that state and local governments have the necessary time to implement the conformity rule as originally intended.
      Since 1993, the fundamental purpose of section 93.111(b) of the conformity rule has been to provide a sufficient amount of time for MPOs and other state and local agencies to adapt to using new emissions tools.  As discussed above, the transition to a new emissions model for conformity involves more than learning to use the new model and preparing input data and model output.  After model start-up is complete, state and local agencies also need to consider how the model affects regional conformity analysis results and whether SIP and/or transportation plan/TIP changes are necessary to assure future conformity determinations.  EPA believes that this one-time extension of the current MOVES2010a regional grace period is critical to assure future conformity determinations based on MOVES2010a.
      EPA has the discretion to establish an extended grace period for MOVES2010a, and today's action is consistent with CAA section 176(c)(1) requirements.  EPA believes that providing one additional year is appropriate due to technical challenges in the transition from MOBILE6.2 to MOVES2010a.  This decision is consistent with the existing conformity criteria in section 93.111(b)(2) of the conformity rule that requires the length of the grace period to be based on "the degree of change in the model and the scope of re-planning likely to be necessary by MPOs in order to assure conformity."
      Today's action does not delay the use of MOVES2010a in SIP development or slow down past progress toward using the new model for regional conformity analyses.  As noted above, many state and local agencies are already learning and applying MOVES2010a.  Some are revising existing SIP budgets using the new model, while others may be incorporating MOVES2010a into new maintenance plans or clean data determinations.  Under EPA's existing MOVES policy guidance, new or revised SIP budgets must still be based on MOVES2010a.  For example, MOVES2010a continues to be required for attainment SIPs for the 2006 24-hour PM2.5 NAAQS.  MOVES2010a is also required for any regional conformity analyses prior to March 2, 2013 if SIP budgets based on MOVES2010 or MOVES2010a are approved or found adequate sooner.
      In addition, today's action does not change the current MOVES2010a grace period for new PM2.5, PM10, and CO hot-spot analyses for project-level conformity determinations.  EPA noted previously that a two-year conformity grace period was necessary to apply MOVES2010a for hot-spot analyses (75 FR 79370).  However, the transition to MOVES2010a for project-level hot-spot analyses does not involve the complexity associated with the regional level, where SIP budgets and/or transportation plans/TIPs may need to be revised before regional conformity analyses based on MOVES2010a can be completed.
      Finally, EPA is not reopening as a general matter the process and length of conformity grace periods for future emissions model approvals.  The unique set of circumstances involved in the current transition warrants additional state and local flexibility before MOVES2010a is required for regional conformity analyses.
IV.	Conformity SIPs
      The MOVES2010a regional grace period extension applies on the effective date of today's direct final rule in all nonattainment and maintenance areas.  Section 51.390(a) of the conformity rule states that the federal rule applies for the portion of the requirements that are not included in a state's approved conformity SIP.  Section 51.390(b) further allows state conformity provisions to contain criteria and procedures that are more stringent than the federal requirements.  However, in the case of states with conformity SIPs that include the grace period provision in 40 CFR 93.111(b)(1), EPA concludes that such states did not intend to require a shorter grace period than EPA, in consultation with DOT, believes is needed.  Therefore, since the MOVES2010a grace period extension is a new provision being added to the conformity rule, it is not included in any current state conformity SIP and therefore applies immediately in all areas pursuant to section 51.390(a).
      In addition, section 51.390(c) of the conformity rule requires states to submit a new or revised conformity SIP to EPA within 12 months of the Federal Register publication date of any final conformity amendments for certain situations.  States with approved conformity SIPs that are prepared in accordance with current CAA requirements are not required to submit new conformity SIP revisions, since section 93.111 of the conformity rule is not contained in these SIPs.  A conformity SIP prepared in accordance with current CAA requirements contains only the state's criteria and procedures for interagency consultation (40 CFR 93.105) and two additional provisions related to written commitments for certain control and mitigation measures (40 CFR 93.122(a)(4)(ii) and 93.125(c)).  However, states with approved conformity SIPs that include section 93.111 from a previous rulemaking are required to submit a SIP revision by [insert date 12 months from date of publication in the Federal Register], although EPA strongly encourages these states to submit a SIP revision with only the three required provisions.  A state without an approved conformity SIP is not required to submit a new conformity SIP within one year of today's action, but previous conformity SIP deadlines continue to apply.
      For additional information on conformity SIPs, please refer to the January 2009 guidance entitled, "Guidance for Developing Transportation Conformity State Implementation Plans" available on EPA's website at:  www.epa.gov/otaq/stateresources/transconf/policy/420b09001.pdf.
V.	Statutory and Executive Order Reviews
A.	Executive Order 12866: Regulatory Planning and Review
      Under Executive Order (EO) 12866, (58 FR 51735; October 4, 1993), this action is a "significant regulatory action" because it raises novel legal and policy issues.  Accordingly, EPA submitted this action to the Office of Management and Budget (OMB) for review under EO 12866 and any changes made in response to OMB recommendations have been documented in the docket for this action.
B.	Paperwork Reduction Act
      This action does not impose any new information collection burden.  The information collection requirements of EPA's existing transportation conformity regulations and the revisions in today's action are already covered by EPA information collection request (ICR) entitled, "Transportation Conformity Determinations for Federally Funded and Approved Transportation Plans, Programs and Projects."  OMB has previously approved the information collection requirements contained in the existing regulations at 40 CFR Part 93 under the provisions of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq. and has assigned OMB control number 2060-0561.  The OMB control numbers for EPA's regulations in 40 CFR are listed in 40 CFR Part 9.
C.	Regulatory Flexibility Act
	The Regulatory Flexibility Act (RFA) generally requires an Agency to prepare a regulatory flexibility analysis of rules subject to notice-and-comment rulemaking requirements under the Administrative Procedure Act or any other statute unless the Agency certifies that the rule will not have a significant economic impact on a substantial number of small entities.  Small entities include small businesses, small not-for-profit organizations and small government jurisdictions.
	For purposes of assessing the impacts of today's rule on small entities, small entity is defined as: (1) a small business as defined by the Small Business Administration's (SBA) regulations at 13 CFR 121.201; (2) a small governmental jurisdiction that is a government of a city, county, town, school district or special district with a population of less than 50,000; and (3) a small organization that is any not-for-profit enterprise that is independently owned and operated and is not dominant in its field.  After considering the economic impacts of today's rule on small entities, I certify that this action will not have a significant economic impact on a substantial number of small entities.  This regulation directly affects federal agencies and MPOs that, by definition, are designated under federal transportation laws only for metropolitan areas with a population of at least 50,000.  These organizations do not constitute small entities within the meaning of the RFA.  Therefore, this rule will not impose any requirements on small entities.
D.	Unfunded Mandates Reform Act (UMRA)
	This rule does not contain a Federal mandate that may result in expenditures of $100 million or more for state, local, and tribal governments, in the aggregate, or the private sector in any one year.  This rule merely implements already established law that imposes conformity requirements and does not itself impose requirements that may result in expenditures of $100 million or more in any year.  Thus, today's rule is not subject to the requirements of sections 202 and 205 of the UMRA.
	This rule is also not subject to the requirements of section 203 of UMRA because it contains no regulatory requirements that might significantly or uniquely affect small governments.  This rule will not significantly or uniquely impact small governments because it directly affects federal agencies and MPOs that, by definition, are designated under federal transportation laws only for metropolitan areas with a population of at least 50,000.
E.	Executive Order 13132: Federalism
      This rule does not have federalism implications.  It will not have substantial direct effects on states, on the relationship between the national government and states, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132.  The CAA requires conformity to apply in certain nonattainment and maintenance areas as a matter of law, and today's action merely revises one provision for transportation planning entities in subject areas to follow in meeting their existing statutory obligations.  Thus, EO 13132 does not apply to this rule.
F.	Executive Order 13175: Consultation and Coordination with Indian Tribal Governments
 	This action does not have tribal implications, as specified in Executive Order 13175 (65 FR 67249, November 9, 2000).  The CAA requires transportation conformity to apply in any area that is designated nonattainment or maintenance by EPA.  Because today's rule does not significantly or uniquely affect the communities of Indian tribal governments, EO 13175 does not apply to this action.
G.	Executive Order 13045: Protection of Children from Environmental Health and Safety Risks
	This rule is not subject to Executive Order 13045 (62 FR 19885, April 23, 1997) because the Agency does not believe the environmental health or safety risks addressed by this action present a disproportionate risk to children.
H.	Executive Order 13211: Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use
      This action is not a "significant energy action" as defined in Executive Order 13211 (66 FR 18355 (May 22, 2001)), because it is not likely to have a significant adverse effect on the supply, distribution, or use of energy.  It does not create a serious inconsistency or otherwise interfere with an action taken or planned by another agency regarding energy.  This action is not subject to EO 13211 because it does not have any adverse energy effects.
I.	National Technology Transfer and Advancement Act
      Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law No. 104-113, section 12(d) (15 U.S.C. 272 note) directs EPA to use voluntary consensus standards in its regulatory activities unless to do so would be inconsistent with applicable law or otherwise impractical.  Voluntary consensus standards are technical standards (e.g., material specifications, test methods, sampling procedures, and business practices) that are developed or adopted by voluntary consensus standards bodies.  The NTTAA directs EPA to provide Congress, through OMB, explanations when the Agency decides not to use available and applicable voluntary consensus standards.  This rule does not involve technical standards.  Therefore, EPA is not considering the use of any voluntary consensus standards.
J.	Executive Order 12898:  Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations
      Executive Order 12898 (59 FR 7629 (Feb. 16, 1994)) establishes federal executive policy on environmental justice.  Its main provision directs federal agencies, to the greatest extent practicable and permitted by law, to make environmental justice part of their mission by identifying and addressing, as appropriate, disproportionately high and adverse human health or environmental effects of their programs, policies, and activities on minority populations and low-income populations in the United States.
	EPA has determined that this rule will not have disproportionately high and adverse human health or environmental effects on minority or low-income populations.  The final rule involves a minor revision that provides administrative relief but does not change the conformity rule's underlying requirements for regional conformity analyses.
K.	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 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).  This rule will be effective [insert date 30 days after publication in the Federal Register].
List of Subjects in 40 CFR Part 93
Administrative practice and procedure, Air pollution control, Carbon monoxide, Clean Air Act, Environmental protection, Highways and roads, Intergovernmental relations, Mass transportation, Nitrogen dioxide, Ozone, Particulate matter, Transportation, Volatile organic compounds.

DATED: _________________________________

_____________________________________________

Lisa P. Jackson,
Administrator

For the reasons discussed in the preamble, 40 CFR Part 93 is amended as follows:
PART 93  -  [AMENDED]
1.  	The authority citation for Part 93 continues to read as follows:
	Authority:  42 U.S.C. 7401-7671q.
2.  	Section 93.111 is amended by adding paragraph (b)(3) to read as follows:
§93.111 Criteria and procedures:  Latest emissions model.
* * * * *
	(b)  * * *
      (3)  Notwithstanding paragraph (b)(1) of this section, the grace period for using the MOVES2010a emissions model (and minor model revisions) for regional emissions analyses will end on March 2, 2013.
* * * * *


[Federal Register Volume 84, Number 101 (Friday, May 24, 2019)]
[Notices]
[Pages 24158-24159]
[FR Doc No: 2019-10889]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-E-5055]

Determination of Regulatory Review Period for Purposes of Patent
Extension; EDWARDS INTUITY ELITE AORTIC VALVE

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) has
determined the regulatory review period for EDWARDS INTUITY ELITE
AORTIC VALVE and is publishing this notice of that determination as
required by law. FDA has made the determination because of the
submission of an application to the Director of the U.S. Patent and
Trademark Office (USPTO), Department of Commerce, for the extension of
a patent which claims that medical device.

DATES: Anyone with knowledge that any of the dates as published (in the
SUPPLEMENTARY INFORMATION section) are incorrect may submit either
electronic or written comments and ask for a redetermination by July
23, 2019. Furthermore, any interested person may petition FDA for a
determination regarding whether the applicant for extension acted with
due diligence during the regulatory review period by November 20, 2019.
See ``Petitions'' in the SUPPLEMENTARY INFORMATION section for more
information.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before July 23, 2019. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of November 20, 2019. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2017-E-5055 for ``Determination of Regulatory Review Period for
Purposes of Patent Extension; EDWARDS INTUITY ELITE AORTIC VALVE.''
Received comments, those filed in a timely manner (see ADDRESSES), will
be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two

copies total. One copy will include the information you claim to be
confidential with a heading or cover note that states ``THIS DOCUMENT
CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will review this copy,
including the claimed confidential information, in its consideration of
comments. The second copy, which will have the claimed confidential
information redacted/blacked out, will be available for public viewing
and posted on https://www.regulations.gov. Submit both copies to the
Dockets Management Staff. If you do not wish your name and contact
information to be made publicly available, you can provide this
information on the cover sheet and not in the body of your comments and
you must identify this information as ``confidential.'' Any information
marked as ``confidential'' will not be disclosed except in accordance
with 21 CFR 10.20 and other applicable disclosure law. For more
information about FDA's posting of comments to public dockets, see 80
FR 56469, September 18, 2015, or access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6250, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984
(Pub. L. 98-417) and the Generic Animal Drug and Patent Term
Restoration Act (Pub. L. 100-670) generally provide that a patent may
be extended for a period of up to 5 years so long as the patented item
(human drug product, animal drug product, medical device, food
additive, or color additive) was subject to regulatory review by FDA
before the item was marketed. Under these acts, a product's regulatory
review period forms the basis for determining the amount of extension
an applicant may receive.
    A regulatory review period consists of two periods of time: A
testing phase and an approval phase. For medical devices, the testing
phase begins with a clinical investigation of the device and runs until
the approval phase begins. The approval phase starts with the initial
submission of an application to market the device and continues until
permission to market the device is granted. Although only a portion of
a regulatory review period may count toward the actual amount of
extension that the Director of USPTO may award (half the testing phase
must be subtracted as well as any time that may have occurred before
the patent was issued), FDA's determination of the length of a
regulatory review period for a medical device will include all of the
testing phase and approval phase as specified in 35 U.S.C.
156(g)(3)(B).
    FDA has approved for marketing the medical device EDWARDS INTUITY
ELITE AORTIC VALVE. EDWARDS INTUITY ELITE AORTIC VALVE is indicated for
the replacement of diseased, damaged, or malfunctioning native or
prosthetic aortic valves. Subsequent to this approval, the USPTO
received a patent term restoration application for EDWARDS INTUITY
ELITE AORTIC VALVE (U.S. Patent No. 8,911,493) from Edwards
Lifesciences Corp., and the USPTO requested FDA's assistance in
determining this patent's eligibility for patent term restoration. In a
letter dated February 6, 2018, FDA advised the USPTO that this medical
device had undergone a regulatory review period and that the approval
of EDWARDS INTUITY ELITE AORTIC VALVE represented the first permitted
commercial marketing or use of the product. Thereafter, the USPTO
requested that FDA determine the product's regulatory review period.

II. Determination of Regulatory Review Period

    FDA has determined that the applicable regulatory review period for
EDWARDS INTUITY ELITE AORTIC VALVE is 1,508 days. Of this time, 1,203
days occurred during the testing phase of the regulatory review period,
while 305 days occurred during the approval phase. These periods of
time were derived from the following dates:
    1. The date an exemption under section 520(g) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360j(g)) involving this
device became effective: June 28, 2012. FDA has verified the
applicant's claim that the date the investigational device exemption
(IDE) required under section 520(g) of the FD&C Act for human tests to
begin became effective on June 28, 2012.
    2. The date an application was initially submitted with respect to
the device under section 515 of the FD&C Act (21 U.S.C. 360e): October
13, 2015. The applicant claims February 4, 2014, as the date the
premarket approval application (PMA) EDWARDS INTUITY ELITE AORTIC VALVE
(PMA P150036) was initially submitted. However, according to FDA
records, the PMA submitted February 4, 2014, was incomplete, and PMA
P150036 was not submitted as a complete PMA until October 13, 2015.
    3. The date the application was approved: August 12, 2016. FDA has
verified the applicant's claim that PMA P150036 was approved on August
12, 2016.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the USPTO
applies several statutory limitations in its calculations of the actual
period for patent extension. In its application for patent extension,
this applicant seeks 605 days of patent term extension.

III. Petitions

    Anyone with knowledge that any of the dates as published are
incorrect may submit either electronic or written comments and, under
21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as
specified in Sec.  60.30 (21 CFR 60.30), any interested person may
petition FDA for a determination regarding whether the applicant for
extension acted with due diligence during the regulatory review period.
To meet its burden, the petition must comply with all the requirements
of Sec.  60.30, including but not limited to: Must be timely (see
DATES), must be filed in accordance with Sec.  10.20, must contain
sufficient facts to merit an FDA investigation, and must certify that a
true and complete copy of the petition has been served upon the patent
applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42,
1984.) Petitions should be in the format specified in 21 CFR 10.30.
    Submit petitions electronically to https://www.regulations.gov at
Docket No. FDA-2013-S-0610. Submit written petitions (two copies are
required) to the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Dated: May 20, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-10889 Filed 5-23-19; 8:45 am]
 BILLING CODE 4164-01-P