[Federal Register: April 13, 2009 (Volume 74, Number 69)]
[Notices]
[Page 16885]
[DOCID:fr13ap09-84]

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

DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-1818-DR; Docket ID FEMA-2008-0018]

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

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: This notice amends the notice of a major disaster declaration
for the Commonwealth of Kentucky (FEMA-1818-DR), dated February 5,
2009, and related determinations.

DATES: Effective Date: April 2, 2009.

FOR FURTHER INFORMATION CONTACT: Peggy Miller, Disaster Assistance
Directorate, Federal Emergency Management Agency, 500 C Street, SW.,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The notice of a major disaster declaration
for the Commonwealth of Kentucky is hereby amended to include the
following areas among those areas determined to have been adversely
affected by the event declared a major disaster by the President in his
declaration of February 5, 2009.

    Allen and Clay Counties for Public Assistance [Categories C-G],
(already designated for debris removal and emergency protective
measures (Categories A and B), including direct Federal Assistance,
under the Public Assistance program.

The following Catalog of Federal Domestic Assistance Numbers (CFDA)
are to be used for reporting and drawing funds: 97.030, Community
Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling;
97.033, Disaster Legal Services; 97.034, Disaster Unemployment
Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048,
Disaster Housing Assistance to Individuals and Households in
Presidentially Declared Disaster Areas; 97.049, Presidentially
Declared Disaster Assistance--Disaster Housing Operations for
Individuals and Households; 97.050, Presidentially Declared Disaster
Assistance to Individuals and Households--Other Needs; 97.036,
Disaster Grants--Public Assistance (Presidentially Declared
Disasters); 97.039, Hazard Mitigation Grant.

Nancy Ward,
Acting Administrator, Federal Emergency Management Agency.
[FR Doc. E9-8373 Filed 4-10-09; 8:45 am]

BILLING CODE 9111-23-P


[Federal Register Volume 79, Number 92 (Tuesday, May 13, 2014)]
[Notices]
[Pages 27303-27304]
[FR Doc No: 2014-10963]

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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OW-2014-0135; FRL--9910-81-OW]

Updated National Recommended Water Quality Criteria for the
Protection of Human Health

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of Availability.

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

SUMMARY: EPA is announcing the availability of draft updated national
recommended water quality criteria for the protection of human health
for the purpose of obtaining public comments. EPA has updated its
national recommended water quality criteria for human health for
ninety-four chemical pollutants to reflect the latest scientific
information and current EPA policies. This draft update is based on
EPA's current methodology for deriving human health criteria as
described in ``Methodology for Deriving Ambient Water Quality Criteria
for the Protection of Human Health (2000)'' and does not establish new
policy. EPA's recommended water quality criteria provide technical
information for States and authorized Tribes to establish water quality
standards under the Clean Water Act to protect human health.

DATES: The public comment period begins on May 13, 2014 and ends on
July 14, 2014. Technical comments should be submitted to the public EPA
docket by July 14, 2014.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-OW-
2014-0135, by one of the following methods:
     www.regulations.gov: Follow the on-line instructions for
submitting comments.
     Mail: Water Docket, Environmental Protection Agency,
28221T, 1200 Pennsylvania Ave., NW., Washington, DC 20460. Attention
Docket ID No. EPA-HQ-OW-2014-0135.
     Hand Delivery: Water Docket, EPA Docket Center, EPA WJC
West Building Room 3334, 1301 Constitution Ave. NW., Washington, DC,
20004, Attention Docket EPA-HQ-OW-2014-0135. Deliveries to the docket
are accepted only during their normal hours of operation: 8:30 a.m. to
4:30 p.m., Monday through Friday, excluding legal holidays. For access
to docket materials, call<PHONE_NUMBER>, to schedule an appointment.
     Email<EMAIL_ADDRESS>Attention Docket No. EPA-HQ-OW-
2014-0135. To ensure that EPA can properly respond to comments,
commenters should cite the section(s) or chemical(s) in draft updates
to which each comment refers. Commenters should use a separate
paragraph for each issue discussed, and must submit any references
cited in their comments. If you submit an electronic comment, EPA
recommends that you include your name and other contact information in
the body of your comment. Electronic files should avoid any form of
encryption and should be free of any defects or viruses.
    Instructions: Direct your comments to Docket ID No. EPA-HQ-OW-2014-
0135. 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. 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.
    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 Water 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 Water
Docket is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Heidi Bethel at U.S. EPA, Office of
Water, Health and Ecological Criteria Division (Mail Code 4304T), 1200
Pennsylvania Avenue NW., Washington, DC 20460; telephone: (202) 566-
2054; or email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. What should I consider as I prepare my comments for EPA?

    In preparation for submitting comments for EPA on this action,
please review the draft chemical-specific support documents EPA is
publishing (1) in the public docket for this action under Docket ID No.
EPA-HQ-OW-2014-0135, or (2) on EPA's Web site http://water.epa.gov/scitech/swguidance/standards/criteria/current/hhdraft.cfm. Provide EPA
with comments regarding scientific views related to the draft updated
national recommended water quality criteria for protecting human
health. Include any recommended references for data or other scientific
information to be considered by EPA.

II. What are recommended water quality criteria?

    EPA's recommended water quality criteria are scientifically derived
numeric values that protect aquatic life or human health from the
deleterious effects of pollutants in ambient water.

    Section 304(a)(1) of the Clean Water Act (CWA) requires EPA to
develop and publish and, from time to time, revise, criteria for
protection of water quality and human health that accurately reflect
the latest scientific knowledge. Water quality criteria developed under
section 304(a) are based solely on data and scientific judgments on the
relationship between pollutant concentrations and environmental and
human health effects. Section 304(a) criteria do not reflect
consideration of economic impacts or the technological feasibility of
meeting pollutant concentrations in ambient water.
    EPA's recommended Section 304(a) criteria provide technical
information to States and authorized Tribes in adopting water quality
standards that ultimately provide a basis for assessing water body
health and controlling discharges or releases of pollutants. Under the
CWA and its implementing regulations, States and authorized Tribes are
to adopt water quality criteria to protect designated uses (e.g.,
public water supply, aquatic life, recreational use, or industrial
use). EPA's recommended water quality criteria do not substitute for
the CWA or regulations, nor are they regulations themselves. Thus,
EPA's recommended criteria do not impose legally binding requirements.
States and authorized Tribes have the discretion to adopt, where
appropriate, other scientifically defensible water quality criteria
that differ from these recommendations.

III. What are the updated criteria?

    Today, EPA is publishing draft updated national recommended water
quality criteria for the protection of human health for ninety-four
chemical pollutants. These revisions are based on EPA's current
methodology for deriving human health criteria (See: Methodology for
Deriving Ambient Water Quality Criteria for the Protection of Human
Health (2000), EPA-822-B-00-004, October 2000). The methodology
describes EPA's current approach for deriving national recommended
water quality criteria for the protection of human health.
    The revision of these criteria represents a systematic update of
EPA's national recommended 304(a) criteria. EPA has previously
described its process for publishing revised criteria [see National
Recommended Water Quality Criteria--Correction (64 FR 19781; or EPA
822-Z-99-001) or the Federal Register Notice for EPA's 2000 Methodology
(65 FR 66444)]. EPA is announcing the availability of the updated human
health criteria in today's Notice in order to solicit scientific views.
EPA has updated the draft human health criteria using information
sources and models that have previously undergone external peer review.
A fact sheet and a summary of updated input parameters (e.g., cancer
slope factor, reference dose, and bioaccumulation factors) used to
derive the updated criteria was prepared to assist reviewers. EPA has
also developed chemical-specific support documents for each of the
ninety-four chemical pollutants. The support documents detail the
latest scientific information supporting the updated draft human health
criteria, particularly the updated toxicity and exposure input values.
All of these documents are available in the docket (EPA-HQ-OW-2014-
0135) and on EPA's Web site http://water.epa.gov/scitech/swguidance/standards/criteria/current/hhdraft.cfm.

IV. What is the relationship between the draft national recommended
water quality criteria and your state or tribal water quality
standards?

    As part of the water quality standards triennial review process
defined in section 303(c)(1) of the CWA, the States and authorized
Tribes are responsible for maintaining and revising water quality
standards. Water quality standards consist of designated uses, water
quality criteria to protect those uses, a policy for antidegradation,
and may include general policies for application and implementation.
Section 303(c)(1) requires States and authorized Tribes to review and
modify, if appropriate, their water quality standards at least once
every three years.
    States and authorized Tribes must adopt water quality criteria that
protect designated uses. Protective criteria are based on a sound
scientific rationale and contain sufficient parameters or constituents
to protect the designated uses. Criteria may be expressed in either
narrative or numeric form. States and authorized Tribes have four
options when adopting water quality criteria for which EPA has
published section 304(a) criteria. They can:
    (1) Establish numerical values based on recommended section 304(a)
criteria;
    (2) Adopt section 304(a) criteria modified to reflect site specific
conditions;
    (3) Adopt criteria derived using other scientifically defensible
methods; or
    (4) Establish narrative criteria where numeric criteria cannot be
determined (40 CFR 131.11).
    EPA believes that it is important for States and authorized Tribes
to consider any new or updated 304(a) criteria as part of their
triennial review to ensure that state or tribal water quality standards
reflect current science and protect applicable designated uses. These
updated criteria recommendations may change based on scientific views
shared in response to this notice, but once final they would supersede
EPA's previous recommendations.
    Consistent with 40 CFR 131.21, new or revised water quality
criteria adopted into law or regulation by States and authorized Tribes
on or after May 30, 2000 are in effect for CWA purposes only after EPA
approval.

    Dated: April 29, 2014.
Nancy K. Stoner,
Acting Assistant Administrator, Office of Water.
[FR Doc. 2014-10963 Filed 5-12-14; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: August 16, 2006 (Volume 71, Number 158)]
[Notices]
[Page 47202-47203]
[DOCID:fr16au06-73]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Notice of Application Accepted for Filing and Soliciting Motions
To Intervene, Protests, and Comments

August 9, 2006.
    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection:
    a. Type of Application: Preliminary Permit.
    b. Project No.: 12700-000.
    c. Date filed: June 8, 2006.
    d. Applicant: Georges C. St Laurent, Jr.
    e. Name of Project: St Laurent Land and Cattle Company.
    f. Location: On a 1500 acre private ranch in Jackson County,
Oregon. The water is from the Nichols Gap Creek and an irrigation
district owned by Eagle Point Irrigation District.
    g. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791(a)-825(r).
    h. Applicant Contact: Mr. Richard Enloe, Enloe & Associates, Inc.,
2350 Ave. G, White City, OR 97503,<PHONE_NUMBER>, Ext. 1016, E-mail
<EMAIL_ADDRESS>
    i. FERC Contact: Patricia W. Gillis at<PHONE_NUMBER>.
    j. Deadline for filing comments, protests, and motions to
intervene: 60 days from the issuance date of this notice.
    The Commission's Rules of Practice and Procedure require all
intervenors filing documents with the Commission to serve a copy of
that document on each person in the official service list for the
project. Further, if an intervenor files comments or documents with the
Commission relating to the merits of an issue that may affect the
responsibilities of a particular resource agency, they must also serve
a copy of the document on that resource agency.
    k. Description of Project: The proposed project would consist of
the following two developments:

The Lower Development

    (1) An existing channel, (2) a proposed intake structure, (3) a
proposed underground 4,300-foot-long, 48-inch-diameter steel penstock,
(4) a proposed powerhouse containing one generating unit with an
installed capacity of 600-kilowatts, (5) a proposed 4,500-foot-long,
12.47 kilovolt transmission line, and (6) appurtenant facilities. The
proposed project would have an average annual generation of 2,623
gigawatt-hours, which would be sold to a local utility.

The Upper Development

    (1) An existing channel, (2) a proposed intake structure, (3) a
proposed underground 1,450-foot-long 36-inch-diameter steel penstock,
(4) a proposed powerhouse containing one generating unit with an
installed capacity of 400-kilowatts, (5) a proposed 1,450-foot-long
12.47 kilowatt transmission line, and appurtenant facilities. The
proposed project would have an average annual generation of 1,352
gigawatt-hours, which would be sold to a local utility.
    l. Locations of Applications: A copy of the application is
available for inspection and reproduction at the Commission in the
Public Reference Room, located at 888 First Street NE., Room 2A,
Washington, DC 20426, or by calling<PHONE_NUMBER>. This filing may
also be viewed on the Commission's Web site at http://www.ferc.gov

using the ``eLibrary'' link. Enter the docket number excluding the last
three digits in the docket number field to access the document. For
assistance, call toll-free 1-866-208-3676 or e-mail
<EMAIL_ADDRESS>For TTY, call<PHONE_NUMBER>. A copy is

also available for inspection and reproduction at the address in item h
above.
    m. Individuals desiring to be included on the Commission's mailing
list should so indicate by writing to the Secretary of the Commission.
    n. Competing Preliminary Permit: Anyone desiring to file a
competing application for preliminary permit for a proposed project
must submit the competing application itself, or a notice of intent to
file such an application, to the Commission on or before the specified
comment date for the particular application (see 18 CFR 4.36).
Submission of a timely notice of intent allows an interested person to
file the competing preliminary permit application no later than 30 days
after the specified comment date for the particular application. A
competing preliminary permit application must conform with 18 CFR
4.30(b) and 4.36.
    o. Competing Development Application: Any qualified development
applicant desiring to file a competing development application must
submit to the Commission, on or before a specified comment date for the
particular application, either a competing development application or a
notice of intent to file such an application. Submission of a timely
notice of intent to file a development application allows an interested
person to file the competing application no later than 120 days after
the specified comment date for the particular application. A competing
license application must conform with 18 CFR 4.30(b) and 4.36.
    p. Notice of Intent: A notice of intent must specify the exact
name, business address, and telephone number of the prospective
applicant, and must include an unequivocal statement of intent to
submit, if such an application may be filed, either a preliminary
permit application or a development application (specify which type of
application). A notice of intent must be served on the applicant(s)
named in this public notice.
    q. Proposed Scope of Studies under Permit: A preliminary permit, if
issued, does not authorize construction. The term of the proposed
preliminary permit would be 36 months. The work proposed under the
preliminary permit would include economic analysis, preparation of
preliminary engineering

plans, and a study of environmental impacts. Based on the results of
these studies, the Applicant would decide whether to proceed with the
preparation of a development application to construct and operate the
project.
    r. Comments, Protests, or Motions to Intervene: Anyone may submit
comments, a protest, or a motion to intervene in accordance with the
requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211,
.214. In determining the appropriate action to take, the Commission
will consider all protests or other comments filed, but only those who
file a motion to intervene in accordance with the Commission's Rules
may become a party to the proceeding. Any comments, protests, or
motions to intervene must be received on or before the specified
comment date for the particular application.
    Comments, protests and interventions may be filed electronically
via the Internet in lieu of paper; See 18 CFR 385.2001 (a)(1)(iii) and
the instructions on the Commission's Web site under ``e-filing'' link.
The Commission strongly encourages electronic filing.
    s. Filing and Service of Responsive Documents: Any filings must
bear in all capital letters the title ``COMMENTS'', ``RECOMMENDATIONS
FOR TERMS AND CONDITIONS'', ``PROTEST'', OR ``MOTION TO INTERVENE'', as
applicable, and the Project Number of the particular application to
which the filing refers. Any of the above-named documents must be filed
by providing the original and the number of copies provided by the
Commission's regulations to: The Secretary, Federal Energy Regulatory
Commission, 888 First Street, NE., Washington, DC 20426. A copy of any
motion to intervene must also be served upon each representative of the
Applicant specified in the particular application.
    t. Agency Comments: Federal, state, and local agencies are invited
to file comments on the described application. A copy of the
application may be obtained by agencies directly from the Applicant. If
an agency does not file comments within the time specified for filing
comments, it will be presumed to have no comments. One copy of an
agency's comments must also be sent to the Applicant's representatives.

Magalie R. Salas,
Secretary.
 [FR Doc. E6-13369 Filed 8-15-06; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register: November 19, 2008 (Volume 73, Number 224)]
[Notices]
[Page 69632]
[DOCID:fr19no08-75]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. PL09-3-000]

Control and Affiliation for Purposes of the Commission's Market-
Based Rate Requirements Under Section 205 of the Federal Power Act and
the Requirements of Section 203 of the Federal Power Act; Notice of
Workshop

November 12, 2008.
    Take notice that on December 3, 2008, Commission staff will convene
a workshop to consider issues regarding control and affiliation for
purposes of the Commission's market-based rate requirements under
section 205 of the Federal Power Act (FPA) and the requirements of
section 203 of the FPA.\1\ The workshop will be held from 9 a.m. to 12
p.m. (EST), in Hearing Room 7 at the Federal Energy Regulatory
Commission, 888 First Street, NE., Washington, DC 20426.
---------------------------------------------------------------------------

    \1\ This workshop is being held in accordance with the
Commission's order Obtaining Guidance on Regulatory Requirements,
123 FERC ] 61,157 (2008).
---------------------------------------------------------------------------

    The purpose of this notice is to advise the public of the date and
time of the workshop. Subsequent notices will be issued regarding the
details of the workshop.
    All interested persons are invited. Those interested in
participating are asked to register no later than November 28, 2008. To
register or for additional information, please contact Christina Hayes
at<PHONE_NUMBER> or at<EMAIL_ADDRESS>    Commission conferences are accessible under section 508 of the
Rehabilitation Act of 1973. For accessibility accommodations, please
send an e-mail to<EMAIL_ADDRESS>or call toll free 1-866-208-
3372 (voice) or<PHONE_NUMBER> (TTY), or send a FAX to<PHONE_NUMBER>
with the required accommodations.

Kimberly D. Bose,
Secretary.
[FR Doc. E8-27365 Filed 11-18-08; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 78, Number 53 (Tuesday, March 19, 2013)]
[Rules and Regulations]
[Pages 16785-16790]
[FR Doc No: 2013-06210]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R05-OAR-2012-0884; EPA-R05-OAR-2012-0970; FRL-9790-2]

Approval and Promulgation of Air Quality Implementation Plans;
Ohio; Cleveland-Akron-Lorain and Columbus 1997 8-Hour Ozone Maintenance
Plan Revisions to Approved Motor Vehicle Emissions Budgets

AGENCY: Environmental Protection Agency (EPA).

ACTION: Direct final rule.

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

SUMMARY: EPA is approving the request by Ohio to revise the Cleveland-
Akron-Lorain and the Columbus, Ohio 1997 8-hour ozone maintenance air
quality State Implementation Plans (SIPs) under the Clean Air Act (CAA)
to replace the previously approved motor vehicle emissions budgets
(budgets) with budgets developed using EPA's Motor Vehicle Emissions
Simulator (MOVES) emissions model. Ohio submitted the SIP revision
requests to EPA on October 30, 2012, and December 12, 2012,
respectively.

DATES: This direct final rule will be effective May 20, 2013, unless
EPA receives adverse comments by April 18, 2013. If adverse comments
are received, EPA will publish a timely withdrawal of the direct final
rule in the Federal Register informing the public that the rule will
not take effect.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R05-
OAR-2012-0884 and EPA-R05-OAR-2012-0970, 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: Pamela Blakley, Chief, Control Strategies Section, Air
Programs Branch (AR-18J), U.S. Environmental Protection Agency, 77 West
Jackson Boulevard, Chicago, Illinois 60604.
    5. Hand Delivery: Pamela Blakley, Chief, Control Strategies
Section, Air Programs Branch (AR-18J), U.S. Environmental Protection
Agency, 77 West Jackson Boulevard, Chicago, Illinois 60604. Such
deliveries are only accepted during the Regional Office normal hours of
operation, and special arrangements should be made for deliveries of
boxed information. The Regional Office 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-R05-OAR-
2012-0884 and EPA-R05-OAR-2012-0970. 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 email. 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. 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 Environmental Protection
Agency, Region 5, Air and Radiation Division, 77 West Jackson
Boulevard, Chicago, Illinois 60604. This facility is open from 8:30
a.m. to 4:30 p.m., Monday through Friday, excluding Federal holidays.
We recommend that you telephone Anthony Maietta, Environmental
Scientist, at<PHONE_NUMBER> before visiting the Region 5 office.

FOR FURTHER INFORMATION CONTACT: Anthony Maietta, Environmental
Scientist, Control Strategies Section, Air Programs Branch (AR-18J),
Environmental Protection Agency, Region 5, 77 West Jackson Boulevard,
Chicago, Illinois 60604,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document whenever ``we,''
``us,'' or ``our'' is used, we mean EPA. This SUPPLEMENTARY INFORMATION
section is arranged as follows:
I. What is EPA approving?
II. What is the background for this action?
    a. SIP Budgets and Transportation Conformity
    b. Prior Approval of Budgets
    c. The MOVES Emissions Model and Regional Transportation
Conformity Grace Period
    d. Submission of New Budgets Based on MOVES2010a
III. What are the criteria for approval?
IV. What Is EPA's analysis of the State's submittal?
    a. The Revised Inventories
    b. Approvability of the MOVES2010a-Based Budgets
    c. Applicability of MOBILE6.2-Based Budgets
V. What action is EPA taking?
VI. Statutory and Executive Order Reviews

I. What is EPA approving?

    EPA is approving new MOVES2010a-based budgets for the Cleveland-
Akron-Lorain and the Columbus, Ohio, 1997 8-hour ozone maintenance
areas. The Cleveland-Akron-Lorain and the Columbus, Ohio areas were
redesignated to attainment of the 1997 8-hour ozone standard effective
September 15, 2009, (74 FR 47414 and 74 FR 47404), and MOBILE6.2-based
budgets were approved in those actions. The newly submitted MOVES2010a-
based budgets will replace the existing MOBILE6.2-based budgets in the
Ohio 1997 8-hour ozone maintenance plans and must then be used in
future transportation conformity analyses for the area. At that time,
the previously approved MOBILE6.2-based budgets would no longer be
applicable for transportation conformity purposes.
    The Cleveland-Akron-Lorain and the Columbus, Ohio 1997 8-hour ozone
maintenance areas must use the MOVES2010a-based budgets starting on the
effective date of this action. See the official release of the
MOVES2010 emissions model (75 FR 9411-9414) for background, and section
II.(c) below for details.

II. What is the background for this action?

a. SIP Budgets and Transportation Conformity

    Under the CAA, states are required to submit, at various times,
control strategy SIP revisions and maintenance plans for nonattainment
and maintenance areas for a given National Ambient Air Quality Standard
(NAAQS). These emission control strategy SIP revisions (e.g.,
reasonable further progress (RFP) and attainment demonstration SIP
revisions) and maintenance plans include budgets of on-road mobile
source emissions for criteria pollutants and/or their precursors to
address pollution from cars, trucks and other on-road vehicles. These
mobile source SIP budgets are the portions of the total emissions that
are allocated to on-road vehicle use that, together with emissions from
other sources in the area, will provide for attainment or maintenance
if they are not exceeded. The budget serves as a ceiling on emissions
from an area's planned transportation system. For more information
about budgets, see the preamble to the November 24, 1993,
transportation conformity rule (58 FR 62188).
    Under section 176(c) of the CAA, transportation plans,
Transportation Improvement Programs (TIPs), and transportation projects
must ``conform'' to (i.e., be consistent with) the SIP before they can
be adopted or approved. Conformity to the SIP means that transportation
activities will not cause new air quality violations, worsen existing
air quality violations, or delay timely attainment of the NAAQS or
delay an interim milestone. The transportation conformity regulations
can be found at 40 CFR part 51, subpart T, and part 93.
    In general, before budgets can be used in conformity
determinations, EPA must affirmatively find the budgets adequate.
However, budgets that are replacing approved budgets must be found
adequate and approved before budgets can replace older budgets. If the
submitted SIP budgets are meant to replace budgets for the same
purpose, as is the case with Ohio's MOVES2010a 1997 8-hour ozone
maintenance plan budgets, EPA must approve the revised SIP and budgets,
and must affirm that they are adequate at the same time. Once EPA
approves revised budgets into the SIP, they must be used by state and
Federal agencies in determining whether transportation activities
conform to the SIP as required by section 176(c) of the CAA. EPA's
substantive criteria for determining the adequacy of budgets are set
out in 40 CFR 93.118(e)(4).

b. Prior Approval of Budgets

    EPA had previously approved budgets for the Cleveland-Akron-Lorain
and the Columbus, Ohio, 8-hour ozone maintenance areas for volatile
organic compounds (VOCs) and nitrogen oxides (NOX) for the
year 2012 and 2020 on September 15, 2009, (74 FR 47414 and 74 FR
47404). These budgets were based on EPA's MOBILE6.2 emissions model.
The ozone maintenance plans established 2012 and 2020 budgets for the
Cleveland-Akron-Lorain and the Columbus, Ohio areas. The 2012 approved
budgets for VOCs NOX and the 2020 budgets for VOCs and
NOX were approved in the September 15, 2009, rulemakings.
These budgets demonstrated a reduction in emissions from the monitored
attainment year and included a margin of safety.

c. The MOVES Emissions Model and Regional Transportation Conformity
Grace Period

    The MOVES model is EPA's state of the art tool for estimating
highway emissions. The model is based on analyses of millions of
emission test results and considerable advances in the agency's
understanding of vehicle emissions. MOVES incorporates the latest
emissions data, more sophisticated calculation algorithms, increased
user flexibility, new software design, and significant new capabilities
relative to those reflected in MOBILE6.2.
    EPA announced the release of MOVES2010 in March 2010 (75 FR 9411).
EPA subsequently released two minor model revisions: MOVES2010a in
September 2010 and MOVES2010b in April 2012. Both of these minor
revisions enhance model performance and do not significantly affect the
criteria pollutant emissions results from MOVES2010. MOVES will be
required for new regional emissions analyses for transportation
conformity determinations (``regional conformity analyses'') outside of
California that begin after March 2, 2013, or when EPA approves MOVES-
based budgets, whichever comes first.\1\ The MOVES grace period for
regional conformity analyses applies to both the use of MOVES2010 and
approved minor revisions (e.g., MOVES2010a and MOVES2010b). For more
information, see EPA's ``Policy Guidance on the Use of MOVES2010 and
Subsequent Minor Model Revisions for State Implementation Plan
Development, Transportation Conformity, and Other Purposes'' (April
2012), available online at: www.epa.gov/otaq/stateresources/transconf/policy.htm#models.
---------------------------------------------------------------------------

    \1\ Upon the release of MOVES2010, EPA established a two-year
grace period before MOVES is required to be used for regional
conformity analyses (75 FR 9411, March 2, 2010). EPA subsequently
promulgated a final rule on February 27, 2012 to provide an
additional year before MOVES is required for these analyses (77 FR
11394). In this case the grace period ends on March 2, 2013.
---------------------------------------------------------------------------

    EPA has encouraged areas to examine how MOVES would affect future
transportation plan and TIP conformity determinations so, if necessary,
SIPs and budgets could be revised with MOVES or transportation plans
and TIPs could be revised (as appropriate) prior to the end of the
regional transportation conformity grace period. EPA has also
encouraged state and local air agencies to consider how the release of
MOVES would affect analyses supporting SIP submissions under
development (77 FR 9411, March 2, 2010, and 77 FR 11394, February 27,
2012).
    The Metropolitan Planning Organizations (MPOs) for the Cleveland-
Akron-Lorain and the Columbus, Ohio areas have used MOVES2010a emission
rates with the transportation network information to estimate emissions
in the years of the transportation plan and also for the SIP. The
budgets have been revised using the latest planning assumptions
including population and

employment updates. In addition, newer vehicle registration data has
been used to update the age distribution of the vehicle fleet. Since
MOVES2010 (or a minor model revision) will be required for conformity
analyses after the grace period ends, the MPOs have concluded that
updating the budgets with MOVES2010a will prepare the areas for the
transition to using MOVES for conformity analyses and determinations.
The interagency consultation group has had extensive consultation on
the requirements and need for new budgets.

d. Submission of New Budgets Based on MOVES2010a

    On October 30, 2012, and December 12, 2012, Ohio submitted final
budgets based on MOVES2010a that cover the Ohio areas of Cleveland-
Akron-Lorain and Columbus, Ohio. Ohio received no comments during the
public review and comment period.
    The MOVES2010a based budgets will replace the prior approved
MOBILE6.2 based budgets and are for the same years and pollutants/
precursors. The new MOVES2010a based budgets are for the years 2012 and
2020 for both VOCs and NOX and are detailed in Tables 5 and
6 of this notice. Ohio has also provided total emissions including
mobile emissions based on MOVES2010a, for the attainment year of 2006,
and the 2020 maintenance year. The safety margin is defined as the
reduction in emissions from the base year (in this case the 2006
attainment year) to the final year of the maintenance plan (in this
case the 2020 year). The total emissions include point, area, non-road
mobile and on-road mobile sources. The available safety margin for each
area is shown in Tables 1 and 2.

           Table 1--Table of Total Emissions With MOVES2010a Mobile Emissions--Cleveland-Akron-Lorain
                                              [Tons per summer day]
----------------------------------------------------------------------------------------------------------------
                              Year                                     2006            2020        Safety margin
----------------------------------------------------------------------------------------------------------------
VOC.............................................................          121.59           37.54           84.05
NOX.............................................................          274.22           94.23          179.99
----------------------------------------------------------------------------------------------------------------

                  Table 2--Table of Total Emissions With MOVES2010a Mobile Emissions--Columbus
                                              [Tons per summer day]
----------------------------------------------------------------------------------------------------------------
                              Year                                     2006            2020        Safety margin
----------------------------------------------------------------------------------------------------------------
VOC.............................................................          260.58          128.59          131.99
NOX.............................................................          330.99          127.29          203.70
----------------------------------------------------------------------------------------------------------------

    The MPOs have added only a small portion of the overall safety
margin available for NOX and VOCs to the budgets for 2012
and 2020. The submittal demonstrates how all emissions decline from the
attainment year of 2006. In 2006, the total estimated NOX
emissions from all sources in the Cleveland-Akron-Lorain area
(including mobile, point, area and non-road sources) is 274.22 tons per
day (tpd) and the total VOC emissions, for the 2006 attainment year,
from all sources is 121.59 tpd. The 2020 estimated emissions for total
NOX from all sources is 94.23 tpd and the total VOC
emissions from all sources is 37.54 tpd. This reduction in emissions
demonstrates that the area will continue below the attainment level of
emissions and maintain the 1997 8-hour ozone standard. The mobile
source emissions, when included with point, area and non-road sources
continue to demonstrate maintenance of the attainment level of
emissions in the Ohio areas of Cleveland-Akron-Lorain and Columbus,
Ohio.
    No additional control measures were needed to maintain the 1997
ozone standard in the Cleveland-Akron-Lorain and the Columbus, Ohio
areas. An appropriate safety margin for NOX and VOCs was
decided by the interagency consultation group (the interagency
consultation group as required by the state conformity agreement
consists of representatives from the Federal Highway Administration,
the Ohio Environmental Protection Agency (OEPA), Ohio Department of
Transportation, and EPA). The submitted budgets for the Cleveland-
Akron-Lorain and the Columbus, Ohio areas are shown in Tables 5 and 6.
These budgets will continue to keep emissions in the Cleveland-Akron-
Lorain and the Columbus, Ohio areas below the calculated attainment
year of emissions.

III. What are the criteria for approval?

    EPA requires that revisions to existing SIPs and budgets continue
to meet applicable requirements (e.g., RFP, attainment, or
maintenance). States that revise their existing SIPs to include MOVES
budgets must therefore show that the SIP continues to meet applicable
requirements with the new level of motor vehicle emissions contained in
the budgets. The SIP must also meet any applicable SIP requirements
under CAA section 110.
    In addition, the transportation conformity rule (at 40 CFR
93.118(e)(4)(iv)) requires that ``the budgets, when considered together
with all other emissions sources, is consistent with applicable
requirements for RFP, attainment, or maintenance (whichever is relevant
to the given implementation plan submission).'' This and the other
adequacy criteria found at 40 CFR 93.118(e)(4) must be satisfied before
EPA can find submitted budgets adequate and approve them for conformity
purposes.
    In addition, areas can revise their budgets and inventories using
MOVES without revising their entire SIP if (1) the SIP continues to
meet applicable requirements when the previous motor vehicle emissions
inventories are replaced with MOVES base year and milestone,
attainment, or maintenance year inventories, and (2) the state can
document that growth and control strategy assumptions for non-motor
vehicle sources continue to be valid and any minor updates do not
change the overall conclusions of the SIP. For example, the first
criterion could be satisfied by demonstrating that the emissions
reductions between the baseline/attainment year and maintenance year
are the same or greater using MOVES than they were previously. The
submittal meets this requirement as described below in section V.
    For more information, see EPA's latest ``Policy Guidance on the Use
of MOVES2010 for SIP Development, Transportation Conformity, and Other

Purposes'' (April 2012), available online at: www.epa.gov/otaq/stateresources/transconf/policy.htm#models.

IV. What is EPA's analysis of the State's submittal?

a. The Revised Inventories

    The Ohio SIP revision requests for the Cleveland-Akron-Lorain and
the Columbus, Ohio 1997 ozone maintenance plans seek to revise only the
on-road mobile source inventories and not the non-road inventories,
area source inventories or point source inventories for the 2012 and
2020 years for which the SIP revises the budgets. OEPA has certified
that the control strategies remain the same as in the original SIP, and
that no other control strategies are necessary. This is confirmed by
the monitoring data for the Cleveland-Akron-Lorain and the Columbus,
Ohio areas, which continue to monitor attainment for the 1997 8-hour
ozone standard. Thus, the current control strategies are continuing to
keep the area in attainment of the NAAQS.
    EPA has reviewed the emission estimates for point, area and non-
road sources and concluded that no major changes to the projections
need to be made. Ohio finds that growth and control strategy
assumptions for non-mobile sources (i.e., area, non-road, and point)
have not changed significantly from the original submittal for the
years 2006, 2012, and 2020. As a result, the growth and control
strategy assumptions for the non-mobile sources for the years 2006,
2012, and 2020 continue to be valid and do not affect the overall
conclusions of the plan.
    Ohio's submissions confirm that the SIP continues to demonstrate
its purpose of maintaining the 1997 ozone standard because the
emissions are continuing to decrease from the attainment year to the
final year of the maintenance plan. The total emissions in the revised
SIP (which includes MOVES2010a emissions from mobile sources) as shown
in Tables 1 and 2 demonstrate that emissions in the Cleveland-Akron-
Lorain and the Columbus, Ohio areas are continuing to decline and
remain below the attainment levels.
    Ohio has submitted MOVES2010a-based budgets for the Cleveland-
Akron-Lorain and the Columbus, Ohio areas that are clearly identified
in the submittals. The budgets are displayed in Tables 5 and 6.

b. Approvability of the MOVES2010a-Based Budgets

    EPA is approving the MOVES2010a-based budgets submitted by Ohio for
use in determining transportation conformity in the Cleveland-Akron-
Lorain and the Columbus, Ohio 1997 ozone maintenance areas. EPA is
making this approval based on our evaluation of these budgets using the
adequacy criteria found in 40 CFR 93.118(e)(4) and our in-depth
evaluation of the State's submittals and SIP requirements. EPA has
determined, based on its evaluation, that the area's maintenance plans
would continue to serve its intended purpose with the submitted
MOVES2010a-based budgets and that the budgets themselves meet the
adequacy criteria in the conformity rule at 40 CFR 93.118(e)(4).
    The adequacy criteria found in 40 CFR 93.118(e)(4) are as follows:
     The submitted SIP was endorsed by [the Governor/Governor's
designee] and was subject to a state public hearing (Sec.
93.118(e)(4)(i));
     Before the control strategy implementation plan was
submitted to EPA, consultation among Federal, state, and local agencies
occurred, and the state fully documented the submittal (Sec.
93.118(e)(4)(ii));
     The budgets are clearly identified and precisely
quantified (Sec.  93.118(e)(4)(iii));
     The budgets, when considered together with all other
emissions sources, are consistent with applicable requirements for RFP,
attainment, or maintenance (Sec.  93.118(e)(4)(iv));
     The budgets are consistent with and clearly related to the
emissions inventory and control measures in the control strategy
implementation plan (Sec.  93.118(e)(4)(v)); and
     The revisions explain and document changes to the previous
budgets, impacts on point and area source emissions and changes to
established safety margins and reasons for the changes (including the
basis for any changes related to emission factors or vehicle miles
traveled) (Sec.  93.118(e)(4)(vi)).
    We find that Ohio has met all of the adequacy criteria. Public
hearing materials were submitted with the formal SIP revision request.
The interagency consultation group, which is composed of the state air
agencies, state departments of transportation, Federal Highway
Administration, EPA and the MPO for the area, has discussed and
reviewed the budgets developed with MOVES2010a and the safety margin
allocation. The budgets are clearly identified and precisely quantified
in the submittals. The budgets when considered with other emissions
sources (point, area, non-road) are consistent with continued
maintenance of the 1997 ozone standard. The budgets are clearly related
to the emissions inventory and control measures in the SIP. The changes
from the previous budgets are clearly explained with the change in the
model from MOBILE6.2 to MOVES2010a and the revised and updated planning
assumptions. The inputs to the model are detailed in the submittal. EPA
has reviewed the inputs to the MOVES2010a modeling and participated in
the consultation process. The Federal Highway Administration and the
Ohio Department of Transportation have taken a lead role in working
with the MPO to provide accurate, timely information and inputs to the
MOVES2010a model runs. The MPO network models provided the vehicle
miles of travel and other necessary data from the travel demand network
models.
    The CAA requires that revisions to existing SIPs and budgets
continue to meet applicable requirements (in this case, maintenance).
Therefore, states that revise existing SIPs with MOVES must show that
the SIP continues to meet applicable requirements with the new level of
motor vehicle emissions calculated by the new model.
    To that end, Ohio's submitted MOVES2010a based budgets meet EPA's
two criteria for revising budgets without revising the entire SIP:
    (1) The SIP continues to meet applicable requirements when the
previous motor vehicle emissions inventories are replaced with
MOVES2010a base year and milestone, attainment, or maintenance year
inventories, and
    (2) The state can document that growth and control strategy
assumptions for non-motor vehicle sources continue to be valid and any
minor updates do not change the overall conclusions of the SIP.
    Ohio has documented that growth and control strategy assumptions
continue to be valid and do not change the overall conclusions of the
maintenance plan. The emission estimates for point, area and non-road
sources have not changed. Ohio finds that growth and control strategy
assumptions for non-mobile sources (i.e. area, non-road, and point)
from the original submittal for the years 2006, 2012, 2020 were
developed before the down-turn in the economy over the last several
years. Because of this, the factors included in the original submittal
may project more growth than actual into the future. As a result, the
growth and control strategy assumptions for the non-mobile sources for
the years 2006, 2012, and 2020 continue to be valid and do not affect
the overall conclusions of the plan.

    Ohio's submissions confirm that the SIP continues to demonstrate
its purpose of maintaining the 1997 ozone standard because the
emissions are continuing to decrease from the attainment year to the
final year of the maintenance plan. The total emissions under the
revised SIP (which includes MOVES2010a emissions for mobile sources)
decrease from the 2006 attainment year to the year 2020 (the last year
of the maintenance plan). These totals demonstrate that emissions in
the Cleveland-Akron-Lorain and the Columbus, Ohio areas are continuing
to decline and remain below the attainment levels. Tables 3 and 4
display total emissions in both the Cleveland-Akron-Lorain and the
Columbus, Ohio areas including point, area, non-road, and mobile
sources and demonstrates the declining emissions from the 2006
attainment year.

  Table 3--Table of Total Emissions With MOVES2010a Mobile Emissions--
                         Cleveland-Akron-Lorain
                          [Tons per summer day]
------------------------------------------------------------------------
                  Year                         2006            2020
------------------------------------------------------------------------
VOC.....................................          121.59           37.54
NOX.....................................          274.22           94.23
------------------------------------------------------------------------

  Table 4--Table of Total Emissions With MOVES2010a Mobile Emissions--
                                Columbus
                          [Tons per summer day]
------------------------------------------------------------------------
                  Year                         2006            2020
------------------------------------------------------------------------
VOC.....................................          260.58          128.59
NOX.....................................          330.99          127.29
------------------------------------------------------------------------

    Tables 5 and 6 below display the submitted budgets that are being
approved. The budgets include an appropriate margin of safety while
still maintaining total emissions below the attainment level.

    Table 5--Table of Motor Vehicle Emission Budgets (MOVES) for the
                 Cleveland-Akron-Lorain 1997 Ozone Area
                          [Tons per summer day]
------------------------------------------------------------------------
                  Year                         2012            2020
------------------------------------------------------------------------
VOC.....................................           81.54           43.17
NOX.....................................          189.27          108.36
------------------------------------------------------------------------

    Table 6--Table of Motor Vehicle Emission Budgets (MOVES) for the
                        Columbus 1997 Ozone Area
                          [Tons per summer day]
------------------------------------------------------------------------
                  Year                         2012            2020
------------------------------------------------------------------------
VOC.....................................           93.99           50.34
NOX.....................................          188.85           99.12
------------------------------------------------------------------------

    Based on our review of the SIPs and the new budgets provided, EPA
has determined that the SIPs will continue to meet the requirements if
the revised motor vehicle emissions inventories are replaced with
MOVES2010a inventories.

c. Applicability of MOBILE6.2-Based Budgets

    Pursuant to the State's requests, EPA's approval of the revised
budgets means that the existing MOBILE6.2-based budgets will no longer
be applicable for transportation conformity purposes upon the effective
date of this approval.
    In addition, upon this EPA approval of the MOVES2010a-based
budgets, the regional transportation conformity grace period for using
MOBILE6 instead of MOVES2010 (and subsequent minor revisions) for the
pollutants included in these budgets ends for the Cleveland-Akron-
Lorain and Columbus, Ohio 1997 ozone maintenance area.\2\
---------------------------------------------------------------------------

    \2\ For more information, see EPA's ``Policy Guidance on the Use
of MOVES2010 and Subsequent Minor Revisions for State Implementation
Plan Development, Transportation Conformity, and Other Purposes''
(April 2012).
---------------------------------------------------------------------------

V. What action is EPA taking?

    EPA is approving the 2012 and 2020 submitted budgets for the
Cleveland-Akron-Lorain and Columbus, Ohio 1997 ozone maintenance plans.
We are publishing this action without prior proposal because we view
this as a noncontroversial amendment and anticipate no adverse
comments. However, in the proposed rules section of this Federal
Register publication, we are publishing a separate document that will
serve as the proposal to approve the state plan if relevant adverse
written comments are filed. This rule will be effective May 20, 2013
without further notice unless we receive relevant adverse written
comments by April 18, 2013. If we receive such comments, we will
withdraw this action before the effective date by publishing a
subsequent document that will withdraw the final action. All public
comments received will then be addressed in a subsequent final rule
based on the proposed action. EPA will not institute a second comment
period. Any parties interested in commenting on this action should do
so at this time. 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, EPA may adopt as final those
provisions of the rule that are not the subject of an adverse comment.
If we do not receive any comments, this action will be effective May
20, 2013.

VI. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the CAA and applicable
Federal regulations. 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 Order
12866 (58 FR 51735, October 4, 1993);
     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).

In addition, this rule does not have tribal implications as specified
by Executive Order 13175 (65 FR 67249, November 9, 2000), because the
SIP is not approved to apply in Indian country located in the state,
and EPA notes that it will not 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 May 20, 2013. 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, Ozone,
Volatile organic compounds.

    Dated: March 4, 2013.
Susan Hedman,
Regional Administrator, Region 5.

    40 CFR part 52 is amended as follows:

PART 52--[AMENDED]

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

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

0
2. Section 52.1885 is amended by adding paragraph (ff)(13) to read as
follows:

Sec.  52.1885  Control strategy: Ozone.

* * * * *
    (ff) * * *
    (13) Approval--On October 30, 2012, and December 12, 2012, Ohio
submitted a request to revise the approved MOBILE6.2 motor vehicle
emission budgets (budgets) in the 1997 8-hour ozone maintenance plans
for the Cleveland-Akron-Lorain and Columbus, Ohio areas. The budgets
are being revised with budgets developed with the MOVES2010a model. The
2012 motor vehicle emissions budgets for the Cleveland-Akron-Lorain,
Ohio area are 81.54 tpd VOC and 189.27 tpd NOX. The 2020
motor vehicle emissions budgets for the Cleveland-Akron-Lorain, Ohio
area are 43.17 tpd VOC and 108.36 tpd NOX. The 2012 motor
vehicle emissions budgets for the Columbus, Ohio area are 93.99 tpd VOC
and 188.85 tpd NOX. The 2020 motor vehicle emissions budgets
for the Columbus, Ohio area are 50.34 tpd VOC and 99.12 tpd
NOX.
* * * * *

[FR Doc. 2013-06210 Filed 3-18-13; 8:45 am]
BILLING CODE 6560-50-P


			  UNITED STATES OF AMERICA

		        DEPARTMENT OF TRANSPORTATION

			  OFFICE OF THE SECRETARY

			          WASHINGTON, D.C.

			Issued by the Department of Transportation on February 23, 2004

NOTICE OF ACTION TAKEN -- DOCKET OST-2002-11401

________________________________________________________________________
________________________________________________________

This serves as notice to the public of the action described below, taken
by the Department official indicated (no additional confirming order
will be issued in this matter).

Applicant:  Laker Airways (Bahamas) Limited						Date Filed:  February
4, 2004

Relief requested:  Renew exemption from 49 U.S.C. § 41301 to conduct
scheduled foreign air transportation of persons,

property and mail between Freeport/Nassau and Dallas/Ft. Worth,
TX/Milwaukee, WI, on a coterminal basis

with currently authorized U.S.-Bahamas services.

If renewal, date and citation of last action:  February 20, 2003, in
this docket

Applicant representative:  Pierre Murphy<PHONE_NUMBER>		DOT analyst:
Shelita Smith<PHONE_NUMBER>

Responsive pleadings:  None

	DISPOSITION

Action:  Approved									Action date:  February 23, 2004

Effective dates of authority granted:  February 23, 2004 – February
23, 2005

Basis for approval (bilateral agreement/reciprocity):  Reciprocity

Except to the extent exempted/waived, this authority is subject to the
terms, conditions, and limitations indicated:

_X_ Standard exemption conditions (attached)        _X_ Foreign air
carrier permit conditions (Order 96-6-45)

Special conditions/Partial grant/Denial basis/Remarks:

Action taken by:   Paul L. Gretch, Director

		      Office of International Aviation

________________________________________________________________________
____________________________________________________________

We found that the applicant was qualified to perform its proposed
operations.

Under authority assigned by the Department in its regulations, 14 CFR
Part 385, we found that  (1) our action was consistent with Department
policy; (2) grant of the authority was consistent with the public
interest; and (3) grant of the authority would not constitute a major
regulatory action under the Energy Policy and Conservation Act of 1975.
To the extent not granted/deferred/dismissed, we denied all requests in
the referenced Docket.  We may amend, modify, or revoke the authority
granted in this Notice at any time without hearing at our discretion.

Persons entitled to petition the Department for review of the action set
forth in this Notice under the Department’s regulations, 14 CFR
§385.30, may file their petitions within seven (7) days after the date
of issuance of this Notice.  This action was effective when taken, and
the filing of a petition for review will not alter such effectiveness.

An electronic version of this document is available on the World Wide
Web at:

http://dms.dot.gov//reports/reports_aviation.asp

Foreign Carrier Exemption Conditions

In the conduct of the operations authorized, the foreign carrier
applicant(s) shall:

(1)  Not conduct any operations unless it holds a currently effective
authorization from its homeland for such operations, and it has filed a
copy of such authorization with the Department;

(2)  Comply with all applicable requirements of the Federal Aviation
Administration, including, but not limited to, 14 CFR Parts 129, 91, and
36, and with all applicable U.S. Government requirements concerning
security.  To assure compliance with all applicable U.S. Government
requirements concerning security, the holder shall, before commencing
any new service (including charter flights) from a foreign airport that
would be the holder’s last point of departure for the United States,
contact its Principal Security Inspector (PSI) to advise the PSI of its
plans and to find out whether the Transportation Security Administration
has determined that security is adequate to allow such airport(s) to be
served;

(3)  Comply with the requirements for minimum insurance coverage
contained in 14 CFR Part 205, and, prior to the commencement of any
operations under this authority, file evidence of such coverage, in the
form of a completed OST Form 6411, with the Federal Aviation
Administration’s Program Management Branch (AFS-260), Flight Standards
Service (any changes to, or termination of, insurance also shall be
filed with that office);

(4)  Not operate aircraft under this authority unless it complies with
operational safety requirements at least equivalent to Annex 6 of the
Chicago Convention;

(5)  Conform to the airworthiness and airman competency requirements of
its Government for international air services;

(6)  Except as specifically exempted or otherwise provided for in a
Department Order, comply with the requirements of 14 CFR Part 203,
concerning waiver of Warsaw Convention liability limits and defenses;

(7)  Agree that operations under this authority constitute a waiver of
sovereign immunity, for the purposes of 28 U.S.C. 1605(a), but only with
respect to those actions or proceedings instituted against it in any
court or other tribunal in the United States that are: (a)  based on its
operations in international air transportation that, according to the
contract of carriage, include a point in the United States as a point of
origin, point of destination, or agreed stopping place, or for which the
contract of carriage was purchased in the United States; or (b)  based
on a claim under any international agreement or treaty cognizable in any
court or other tribunal of the United States.  In this condition, the
term "international air transportation" means "international
transportation" as defined by the Warsaw Convention, except that all
States shall be considered to be High Contracting Parties for the
purpose of this definition;

(8)  Except as specifically authorized by the Department, originate or
terminate all flights to/from the United States in its homeland;

(9)  Comply with the requirements of 14 CFR Part 217, concerning the
reporting of scheduled, nonscheduled, and charter data;

(10) If charter operations are authorized, except as otherwise provided
in the applicable aviation agreement, comply with the Department's rules
governing charters (including 14 CFR Parts 212 and 380); and

(11) Comply with such other reasonable terms, conditions, and
limitations required by the public interest as may be prescribed by the
Department, with all applicable orders or regulations of other U.S.
agencies and courts, and with all applicable laws of the United States.

This authority shall not be effective during any period when the holder
is not in compliance with the conditions imposed above.  Moreover, this
authority cannot be sold or otherwise transferred without explicit
Department approval under Title 49 of the U.S. Code.

08/2003


[Federal Register Volume 86, Number 118 (Wednesday, June 23, 2021)]
[Notices]
[Pages 32950-32951]
[FR Doc No: 2021-13186]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2020-E-1256; FDA-2020-E-1257; and FDA-2020-E-1258]

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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

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

DATES: Anyone with knowledge that any of the dates as published (see
the SUPPLEMENTARY INFORMATION section) are incorrect may submit either
electronic or written comments and ask for a redetermination by August
23, 2021. Furthermore, any interested person may petition FDA for a
determination regarding whether the applicant for extension acted with
due diligence during the regulatory review period by December 20, 2021.
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 August 23, 2021. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of August 23, 2021. 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 Nos.
FDA-2020-E-1256; FDA-2020-E-1257; and FDA-2020-E-1258, for
``Determination of Regulatory Review Period for Purposes of Patent
Extension; TURALIO.'' 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,<PHONE_NUMBER>.
     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 Sec.
10.20 (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.govinfo.gov/content/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,<PHONE_NUMBER>.

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 human drug products, the
testing phase begins when the exemption to permit the clinical
investigations of the drug becomes effective and runs until the
approval phase begins. The approval phase starts with the initial
submission of an application to market the human drug product and
continues until FDA grants permission to market the drug product.
Although only a portion of a regulatory review period may count toward
the actual amount of extension that the Director of USPTO may award
(for example, half the testing phase must be subtracted as well as any
time that may have occurred before the patent was issued), FDA's
determination of the length of a regulatory review period for a human
drug product will include all of the testing phase and approval phase
as specified in 35 U.S.C. 156(g)(1)(B).
    FDA has approved for marketing the human drug product, TURALIO
(pexidartinib), indicated for treatment of adult patients with
symptomatic tenosynovial giant cell tumor associated with severe
morbidity or functional limitations and not amenable to improvement
with surgery. Subsequent to this approval, the USPTO received patent
term restoration applications for TURALIO (U.S. Patent Nos. 7,893,075;
8,461,169; and 9,169,250) from Plexxikon Inc. and the USPTO requested
FDA's assistance in determining the patents' eligibility for patent
term restoration. In a letter dated May 8, 2020, FDA advised the USPTO
that this human drug product had undergone a regulatory review period
and that the approval of TURALIO 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
TURALIO is 3,637 days. Of this time, 3,394 days occurred during the
testing phase of the regulatory review period, while 243 days occurred
during the approval phase. These periods of time were derived from the
following dates:
    1. The date an exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(i)) became effective:
August 19, 2009. FDA has verified the applicant's claim that the date
the investigational new drug application became effective was on August
19, 2009.
    2. The date the application was initially submitted with respect to
the human drug product under section 505 of the FD&C Act: December 3,
2018. FDA has verified the applicant's claim that the new drug
application (NDA) for TURALIO (NDA 211810) was initially submitted on
December 3, 2018.
    3. The date the application was approved: August 2, 2019. FDA has
verified the applicant's claim that NDA 211810 was approved on August
2, 2019.
    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 applications for patent extension,
this applicant seeks 1,664 days, 1,244 days or 810 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: June 16, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-13186 Filed 6-22-21; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 85, Number 249 (Tuesday, December 29, 2020)]
[Notices]
[Pages 85656-85657]
[FR Doc No: 2020-28722]

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

DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4473-DR; Docket ID FEMA-2020-0001]

Puerto Rico; Amendment No. 8 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: This notice amends the notice of a major disaster declaration
for the Commonwealth of Puerto Rico (FEMA-4473-DR), dated January 16,
2020, and related determinations.

DATES: This amendment was issued September 10, 2020.

FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Notice is hereby given that the incident
period for this disaster is closed effective July 3, 2020.

The following Catalog of Federal Domestic Assistance Numbers (CFDA)
are to be used for reporting and drawing funds: 97.030, Community
Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling;
97.033, Disaster Legal Services; 97.034, Disaster Unemployment
Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048,
Disaster Housing Assistance to Individuals and Households In
Presidentially Declared Disaster Areas; 97.049, Presidentially
Declared Disaster Assistance--Disaster Housing Operations for
Individuals and Households; 97.050, Presidentially Declared Disaster
Assistance to Individuals and Households--Other Needs; 97.036,
Disaster Grants--Public Assistance

(Presidentially Declared Disasters); 97.039, Hazard Mitigation
Grant.

Pete Gaynor,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2020-28722 Filed 12-28-20; 8:45 am]
BILLING CODE 9111-23-P