[Federal Register Volume 76, Number 97 (Thursday, May 19, 2011)]
[Rules and Regulations]
[Pages 28887-28888]
[FR Doc No: 2011-12113]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2011-0432; Airspace Docket No. 11-ACE-8]

Revocation of Class E Airspace; Ozark, MO

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: This action removes Class E airspace at Ozark, MO. Abandonment
of the former Air Park South Airport and cancellation of all Standard
Instrument Approach Procedures has eliminated the need for controlled
airspace in the Ozark, MO area. The FAA is taking this action to ensure
the efficient use of airspace within the National Airspace System.

DATES: Effective date: 0901 UTC, August 25, 2011. The Director of the
Federal Register approves this incorporation by reference action under
1 CFR part 51, subject to the annual revision of FAA Order 7400.9 and
publication of conforming amendments.

FOR FURTHER INFORMATION CONTACT: Scott Enander, Central Service Center,
Operations Support Group, Federal Aviation Administration, Southwest
Region, 2601 Meacham Blvd., Fort Worth, TX 76137; telephone (817) 321-
7716.

SUPPLEMENTARY INFORMATION:

The Rule

    This action amends Title 14 Code of Federal Regulations (14 CFR)
Part 71 by removing Class E airspace in the Ozark, MO, area.
Abandonment of the former Air Park South Airport and cancellation of
all Standard Instrument Approach Procedures has eliminated the need for
controlled airspace. Since this action eliminates the impact of
controlled airspace on users of the National Airspace System in the
vicinity of Ozark, MO, notice and public procedures under 5 U.S.C.
553(b) are unnecessary.
    Class E airspace designations are published in paragraph 6005, of
FAA Order 7400.9U, dated August 18, 2010, and effective September 15,
2010, which is incorporated by reference in 14 CFR part 71.1. The Class
E airspace designation listed in this document will be published
subsequently in this Order.
    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
Therefore, this regulation: (1) Is not a ``significant regulatory
action'' under Executive Order 12866; (2) is not a ``significant rule''
under DOT Regulatory Policies and Procedures (44 FR 11034; February 26,
1979); and (3) does not warrant preparation of a regulatory evaluation
as the anticipated impact is so minimal. Since this is a routine matter
that 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.
    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the U.S. Code. Subtitle 1, Section 106, describes
the authority of the FAA Administrator. Subtitle VII, Aviation
Programs, describes in more detail the scope of the agency's authority.
This rulemaking is promulgated under the authority described in
Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the
FAA is charged with prescribing regulations to assign the use of
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as it removes controlled airspace at Air Park South Airport, Ozark, MO.

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 14 CFR Part 71 continues to read as
follows:

    Authority:  49 U.S.C. 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 part 71.1 of the Federal
Aviation Administration Order 7400.9U, Airspace Designations and
Reporting Points, dated August 18, 2010, and effective September 15,
2010, is amended as follows:

Paragraph 6005 Class E Airspace extending upward from 700 feet
above the surface.

* * * * *

ACE MO E5 Ozark, MO [Removed]

    Issued in Fort Worth, Texas, on May 11, 2011.
Walter L. Tweedy,
Acting Manager, Operations Support Group, ATO Central Service Center.
[FR Doc. 2011-12113 Filed 5-18-11; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 77, Number 52 (Friday, March 16, 2012)]
[Notices]
[Pages 15747-15748]
[FR Doc No: 2012-6394]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings 1

    Take notice that the Commission received the following exempt
wholesale generator filings:

    Docket Numbers: EG12-41-000.
    Applicants: Magic Valley Wind Farm I, LLC.
    Description: Notice of Self-Certification of Exempt Wholesale
Generator Status of Magic Valley Wind Farm I, LLC.
    Filed Date: 3/7/12.
    Accession Number: 20120307-5137.
    Comments Due: 5 p.m. ET 3/28/12.

    Docket Numbers: EG12-42-000.
    Applicants: Wildcat Wind Farm I, LLC.
    Description: Notice of Self-Certification of Exempt Wholesale
Generator Status of Wildcat Wind Farm I, LLC.
    Filed Date: 3/7/12.
    Accession Number: 20120307-5140.
    Comments Due: 5 p.m. ET 3/28/12.

    Docket Numbers: EG12-43-000.
    Applicants: Sherbino I Wind Farm LLC.
    Description: Notice of Self-Certification of EWG status of Sherbino
I Wind Farm LLC.
    Filed Date: 3/7/12.
    Accession Number: 20120307-5180.
    Comments Due: 5 p.m. ET 3/28/12.

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

    Docket Numbers: ER10-1459-002.
    Applicants: FirstEnergy Solutions Corp.
    Description: Revised Affiliate Sales Tariff to be effective 6/1/
2012.
    Filed Date: 3/7/12.
    Accession Number: 20120307-5111.
    Comments Due: 5 p.m. ET 3/28/12.

    Docket Numbers: ER10-1782-002.
    Applicants: Tampa Electric Company.
    Description: Annual Compliance Report Regarding Operational
Penalties of Tampa Electric Company.
    Filed Date: 3/7/12.
    Accession Number: 20120307-5198.
    Comments Due: 5 p.m. ET 3/28/12.

    Docket Numbers: ER12-424-000.
    Applicants: Midwest Independent Transmission System Operator, Inc.,
International Transmission Company.

    Description: J122 Refund Report to be effective N/A.
    Filed Date: 3/8/12.
    Accession Number: 20120308-5045.
    Comments Due: 5 p.m. ET 3/29/12.

    Docket Numbers: ER12-425-000.
    Applicants: Midwest Independent Transmission System Operator, Inc.,
Michigan Electric Transmission Company, LLC.
    Description: J132 Refund Report to be effective N/A.
    Filed Date: 3/8/12.
    Accession Number: 20120308-5046.
    Comments Due: 5 p.m. ET 3/29/12.

    Docket Numbers: ER12-1219-001.
    Applicants: PJM Interconnection, L.L.C.
    Description: Original Service Agreement No. 3249; Queue No. W2-088
to be effective 2/14/2012.
    Filed Date: 3/7/12.
    Accession Number: 20120307-5160.
    Comments Due: 5 p.m. ET 3/28/12.

    Docket Numbers: ER12-1221-000.
    Applicants: AEP Texas North Company.
    Description: 20120307 TNC-Oncor IA to be effective 2/13/2012.
    Filed Date: 3/7/12.
    Accession Number: 20120307-5146.
    Comments Due: 5 p.m. ET 3/28/12.

    Docket Numbers: ER12-1222-000.
    Applicants: Wisconsin Electric Power Company.
    Description: FERC Rate Schedule 115 Amended Service Agreement
Filing to be effective 3/8/2012.
    Filed Date: 3/7/12.
    Accession Number: 20120307-5181.
    Comments Due: 5 p.m. ET 3/28/12.

    Docket Numbers: ER12-1223-000.
    Applicants: Wildcat Wind, LLC.
    Description: Application for Market-Based Rate Authorization to be
effective 5/1/2012.
    Filed Date: 3/7/12.
    Accession Number: 20120307-5182.
    Comments Due: 5 p.m. ET 3/28/12.

    Docket Numbers: ER12-1224-000.
    Applicants: Atlantic Path 15, LLC.
    Description: Offer of Settlement--Base Transmission Revenue
Requirement to be effective 10/13/2011.
    Filed Date: 3/7/12.
    Accession Number: 20120307-5183.
    Comments Due: 5 p.m. ET 3/28/12.

    Docket Numbers: ER12-1225-000.
    Applicants: Fowler Ridge Wind Farm LLC.
    Description: Compliance Filing--Certificate of Concurrence to be
effective N/A.
    Filed Date: 3/7/12.
    Accession Number: 20120307-5184.
    Comments Due: 5 p.m. ET 3/28/12.

    Docket Numbers: ER12-1226-000.
    Applicants: California Independent System Operator Corporation.
    Description: 2012 CAISO REM Compliance Filing to Modify Effective
Date to be effective 4/10/2012.
    Filed Date: 3/7/12.
    Accession Number: 20120307-5185.
    Comments Due: 5 p.m. ET 3/28/12.

    Docket Numbers: ER12-1227-000.
    Applicants: Citizens Energy Corporation.
    Description: Notice of Cancellation of Citizens Energy Corporation.
    Filed Date: 3/8/12.
    Accession Number: 20120308-5023.
    Comments Due: 5 p.m. ET 3/29/12.

    Docket Numbers: ER12-1228-000.
    Applicants: High Majestic Wind II, LLC.
    Description: High Majestic Wind II, LLC MBR Application to be
effective 5/7/2012.
    Filed Date: 3/8/12.
    Accession Number: 20120308-5048.
    Comments Due: 5 p.m. ET 3/29/12.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: March 8, 2012.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2012-6394 Filed 3-15-12; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 86, Number 53 (Monday, March 22, 2021)]
[Notices]
[Pages 15215-15217]
[FR Doc No: 2021-05862]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP21-057-000]

Mountain Valley Pipeline, LLC; Notice of Scoping Period and
Requesting Comments on Environmental Issues for the Proposed Amendment
to the Certificate of Public Convenience and Necessity for the Mountain
Valley Pipeline Project

    The staff of the Federal Energy Regulatory Commission (FERC or
Commission) will prepare an environmental document, that will discuss
the environmental impacts of the Amendment to the Certificate of Public
Convenience and Necessity for the Mountain Valley Pipeline Project
(Amendment Project) involving construction and operation of facilities
by Mountain Valley Pipeline, LLC (Mountain Valley) in Wetzel, Lewis,
Webster, Nicholas, Greenbrier, Summers, and Monroe Counties, West
Virginia and Giles, Montgomery, Roanoke, Franklin, and Pittsylvania
Counties, Virginia. The Commission will use this environmental document
in its decision-making process.
    This notice announces the opening of the scoping process the
Commission will use to gather input from the public and interested
agencies regarding the amendment. As part of the National Environmental
Policy Act (NEPA) review process, the Commission takes into account
concerns the public may have about proposals and the environmental
impacts that could result from its action whenever it considers the
issuance or amendment of a Certificate of Public Convenience and
Necessity. This gathering of public input is referred to as
``scoping.'' The main goal of the scoping process is to focus the
analysis in the environmental document on the important environmental
issues. Additional information about the Commission's NEPA process is
described below in the NEPA Process and Environmental Document section
of this notice.
    By this notice, the Commission requests public comments on the
scope of issues to address in the environmental document. To ensure
that your comments are timely and properly recorded, please submit your
comments so that the Commission receives them in Washington, DC on or
before 5:00 pm Eastern Time on April 15, 2021. Comments may be
submitted in written form. Further details on how to submit comments
are provided in the Public Participation section of this notice.
    Your comments should focus on the potential environmental effects,
reasonable alternatives, and measures to avoid or lessen environmental
impacts. Your input will help the Commission staff determine what
issues they need to evaluate in the environmental document. Commission
staff will consider all written comments during the preparation of the
environmental document.
    If you submitted comments on this project to the Commission before
the opening of this docket on February 19, 2021, you will need to file
those comments in Docket No. CP21-057-000 to ensure they are considered
as part of this proceeding.
    This notice is being sent to the Commission's current environmental
mailing list for this project. State and local government
representatives should notify their constituents of this proposed
project and encourage them to comment on their areas of concern.
    If you are a landowner receiving this notice, a pipeline company
representative may contact you about the acquisition of an easement to
construct, operate, and maintain the proposed facilities. The company
would seek to negotiate a mutually acceptable easement agreement. You
are not required to enter into an agreement. However, if the Commission
approves the project, the Natural Gas Act conveys the right of eminent
domain to the company. Therefore, if you and the company do not reach
an easement agreement, the pipeline company could initiate condemnation
proceedings in court. In such instances, compensation would be
determined by a judge in accordance with state law. The Commission does
not subsequently grant, exercise, or oversee the exercise of that
eminent domain authority. The courts have exclusive authority to handle
eminent domain cases; the

Commission has no jurisdiction over these matters.
    Mountain Valley provided landowners with a fact sheet prepared by
the FERC entitled ``An Interstate Natural Gas Facility On My Land? What
Do I Need To Know?'' which addresses typically asked questions,
including the use of eminent domain and how to participate in the
Commission's proceedings. This fact sheet along with other landowner
topics of interest are available for viewing on the FERC website
(www.ferc.gov) under the Natural Gas Questions or Landowner Topics
link.

Public Participation

    There are three methods you can use to submit your comments to the
Commission. Please carefully follow these instructions so that your
comments are properly recorded. The Commission encourages electronic
filing of comments and has staff available to assist you at (866) 208-
3676 or<EMAIL_ADDRESS>    (1) You can file your comments electronically using the eComment
feature, which is located on the Commission's website (www.ferc.gov)
under the link to FERC Online. Using eComment is an easy method for
submitting brief, text-only comments on a project;
    (2) You can file your comments electronically by using the eFiling
feature, which is located on the Commission's website (www.ferc.gov)
under the link to FERC Online. With eFiling, you can provide comments
in a variety of formats by attaching them as a file with your
submission. New eFiling users must first create an account by clicking
on ``eRegister.'' You will be asked to select the type of filing you
are making; a comment on a particular project is considered a ``Comment
on a Filing''; or
    (3) You can file a paper copy of your comments by mailing them to
the Commission. Be sure to reference the project docket number (CP21-
057-000) on your letter. Submissions sent via the U.S. Postal Service
must be addressed to: Kimberly D. Bose, Secretary, Federal Energy
Regulatory Commission, 888 First Street NE, Room 1A, Washington, DC
20426. Submissions sent via any other carrier must be addressed to:
Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission,
12225 Wilkins Avenue, Rockville, Maryland 20852.
    Additionally, the Commission offers a free service called
eSubscription which makes it easy to stay informed of all issuances and
submittals regarding the dockets/projects to which you subscribe. These
instant email notifications are the fastest way to receive notification
and provide a link to the document files which can reduce the amount of
time you spend researching proceedings. Go to https://www.ferc.gov/ferc-online/overview to register for eSubscription.

Summary of the Proposed Project

    On October 13, 2017, the FERC issued a Certificate of Public
Convenience and Necessity for the Mountain Valley Pipeline Project
under docket CP16-010-000. The Mountain Valley Pipeline Project
consists of approximately 303.5 miles of new natural gas pipeline and
multiple aboveground facilities located in West Virginia and Virginia.
    The Certificate of Public Convenience and Necessity for the
Mountain Valley Pipeline Project authorized open-cut crossings for
wetlands and waterbodies within the construction right-of-way. With the
Amendment Project, Mountain Valley proposes to change the crossing
method for specific wetlands and waterbodies to one of several
trenchless crossing methods. In addition, Mountain Valley proposes two
minor route adjustments to avoid crossing wetlands and waterbodies.
    Specifically, the Amendment Project would consist of the following:
     120 trenchless crossings of 182 waterbodies and wetlands
(this includes 117 conventional bore crossings, 2 Direct Pipe
crossings, and 1 guided conventional bore crossing);
     a minor route adjustment near milepost 230.8 to avoid the
need to cross a waterbody; and
     a minor workspace adjustment near milepost 0.70 to avoid
the need to cross a wetland.

Land Requirements for Construction

    Construction of the trenchless pipeline crossings would not result
in a change of land requirements compared to the previously
Certificated Mountain Valley Pipeline Project. The minor route
adjustment near milepost 230.8 would require approximately 0.13 acre
for construction and 0.04 acre for operation outside of the previously
reviewed workspace for the Certificated Mountain Valley Pipeline
Project. The workspace shift near milepost 0.70 would not result in
additional impacts outside of the already certificated construction and
permanent work areas for the Mountain Valley Pipeline Project.

NEPA Process and the Environmental Document

    Any environmental document issued by the Commission will discuss
impacts that could occur as a result of the construction and operation
of the proposed project under the relevant general resource areas:
     Geology and soils;
     water resources and wetlands;
     vegetation and wildlife;
     threatened and endangered species;
     cultural resources;
     land use;
     air quality and noise; and
     reliability and safety.
    Commission staff have already identified several issues that
deserve attention based on a preliminary review of the proposed
facilities and the environmental information provided by Mountain
Valley. This preliminary list of issues may change based on your
comments and our analysis:
     Protection of water resources and wetlands during the
trenchless crossings;
     noise impacts and air emissions from construction; and
     potential impacts on groundwater from temporary dewatering
activities.
    Commission staff will also evaluate reasonable alternatives to the
proposed project or portions of the project and make recommendations on
how to lessen or avoid impacts on the various resource areas. Your
comments will help Commission staff identify and focus on the issues
that might have an effect on the human environment and potentially
eliminate others from further study and discussion in the environmental
document.
    Following this scoping period, Commission staff will determine
whether to prepare an Environmental Assessment (EA) or an Environmental
Impact Statement (EIS). The EA or the EIS will present Commission
staff's independent analysis of the issues. If Commission staff
prepares an EA, a Notice of Schedule for the Preparation of an
Environmental Assessment will be issued. The EA may be issued for an
allotted public comment period. The Commission would consider timely
comments on the EA before making its decision regarding the proposed
project. If Commission staff prepares an EIS, a Notice of Intent to
Prepare an EIS/Notice of Schedule will be issued, which will open up an
additional comment period. Staff will then prepare a draft EIS which
will be issued for public comment. Commission staff will consider all
timely comments received during the comment period on the draft EIS and
revise the document, as necessary, before issuing a final EIS. Any EA
or draft and final EIS will be available in electronic format in the
public record through eLibrary \1\ and the

Commission's natural gas environmental documents web page (https://www.ferc.gov/industries-data/natural-gas/environment/environmental-documents). If eSubscribed, you will receive instant email notification
when the environmental document is issued.
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    \1\ For instructions on connecting to eLibrary, refer to the
last page of this notice.
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    With this notice, the Commission is asking agencies with
jurisdiction by law and/or special expertise with respect to the
environmental issues of this project to formally cooperate in the
preparation of the environmental document.\2\ Agencies that would like
to request cooperating agency status should follow the instructions for
filing comments provided under the Public Participation section of this
notice.
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    \2\ The Council on Environmental Quality regulations addressing
cooperating agency responsibilities are at Title 40, Code of Federal
Regulations, Section 1501.8.
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Consultation Under Section 106 of the National Historic Preservation
Act

    In accordance with the Advisory Council on Historic Preservation's
implementing regulations for section 106 of the National Historic
Preservation Act, the Commission is using this notice to initiate
consultation with the applicable State Historic Preservation Office(s),
and to solicit their views and those of other government agencies,
interested Indian tribes, and the public on the project's potential
effects on historic properties.\3\ The environmental document for this
project will document findings on the impacts on historic properties
and summarize the status of consultations under section 106.
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    \3\ The Advisory Council on Historic Preservation's regulations
are at Title 36, Code of Federal Regulations, Part 800. Those
regulations define historic properties as any prehistoric or
historic district, site, building, structure, or object included in
or eligible for inclusion in the National Register of Historic
Places.
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Environmental Mailing List

    The environmental mailing list includes federal, state, and local
government representatives and agencies; elected officials;
environmental and public interest groups; Native American Tribes; and
other interested parties. This list also includes all affected
landowners (as defined in the Commission's regulations) who are
potential right-of-way grantors, whose property may be used temporarily
for project purposes, or who own homes within certain distances of
aboveground facilities, and anyone who submits comments on the project
and includes a mailing address with their comments. Commission staff
will update the environmental mailing list as the analysis proceeds to
ensure that Commission notices related to this environmental review are
sent to all individuals, organizations, and government entities
interested in and/or potentially affected by the proposed project.
    If you need to make changes to your name/address, or if you would
like to remove your name from the mailing list, please complete one of
the following:
    (1) Send an email to<EMAIL_ADDRESS>stating your
request. You must include the docket number XXXX-XX-XXX in your
request. If you are requesting a change to your address, please be sure
to include your name and the correct address. If you are requesting to
delete your address from the mailing list, please include your name and
address as it appeared on this notice. This email address is unable to
accept comments;

OR

    (2) Return the attached ``Mailing List Update Form'' (appendix
1).\4\
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    \4\ The appendices referenced in this notice will not appear in
the Federal Register. Copies of the appendices were sent to all
those receiving this notice in the mail and are available at
www.ferc.gov using the link called ``eLibrary''. For instructions on
connecting to eLibrary, refer to the last page of this notice. At
this time, the Commission has suspended access to the Commission's
Public Reference Room due to the proclamation declaring a National
Emergency concerning the Novel Coronavirus Disease (COVID-19),
issued by the President on March 13, 2020. For assistance, contact
FERC at [email protected] or call toll free,<PHONE_NUMBER>
or TTY<PHONE_NUMBER>.
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Additional Information

    Additional information about the project is available from the
Commission's Office of External Affairs, at (866) 208-FERC, or on the
FERC website at www.ferc.gov using the eLibrary link. Click on the
eLibrary link, click on ``General Search'' and enter the docket number
in the ``Docket Number'' field. Be sure you have selected an
appropriate date range. For assistance, please contact FERC Online
Support at<EMAIL_ADDRESS>or<PHONE_NUMBER>, or for TTY,
contact<PHONE_NUMBER>. The eLibrary link also provides access to the
texts of all formal documents issued by the Commission, such as orders,
notices, and rulemakings.
    Public sessions or site visits will be posted on the Commission's
calendar located at https://www.ferc.gov/news-events/events along with
other related information.

    Dated: March 16, 2021.
Kimberly D. Bose,
Secretary.
[FR Doc. 2021-05862 Filed 3-19-21; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 75, Number 78 (Friday, April 23, 2010)]
[Notices]
[Pages 21298-21299]
[FR Doc No: 2010-9512]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2009-E-0172 and FDA-2009-E-0174]

Determination of Regulatory Review Period for Purposes of Patent
Extension; VIMPAT --NDA 22-253

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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SUMMARY:  The Food and Drug Administration (FDA) has determined the
regulatory review period for VIMPAT based on new drug application (NDA)
22-253 for VIMPAT TABLETS 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 Patents
and Trademarks, Department of Commerce, for the extensions of patents
which claim the human drug product, VIMPAT. The regulatory review
period determination for VIMPAT Injection is publishing in this issue
of the Federal Register.

ADDRESSES:  Submit written comments and petitions to the Division of
Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments
to http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT:  Beverly Friedman, Office of
Regulatory Policy, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 51, rm. 6222, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term
Restoration Act of 1984 (Public Law 98-417) and the Generic Animal Drug
and Patent Term Restoration Act (Public Law 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 Patents and
Trademarks 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 recently approved for marketing the human drug product, VIMPAT
(lacosamide). VIMPAT tablets are indicated as adjunctive therapy in the
treatment of partial-onset seizures in patients with epilepsy aged 17
years and older. Subsequent to this approval, the Patent and Trademark
Office received patent term restoration applications for VIMPAT (U.S.
Patent Nos. 5,654,301 and RE38,551) from Research Corporation
Technologies, Inc., and the Patent and Trademark Office requested FDA's
assistance in determining the patents' eligibility for patent term
restoration. In a letter dated September 29, 2009, FDA advised the
Patent and Trademark Office that this human drug product had undergone
a regulatory review period and that the approval of VIMPAT represented
the first permitted commercial marketing or use of the product.
Thereafter, the Patent and Trademark Office requested that FDA
determine the product's regulatory review period.
    FDA has determined that the applicable regulatory review period for
VIMPAT is 3,452 days. Of this time, 3,055 days occurred during the
testing phase of the regulatory review period, while 397 days occurred
during the approval phase. These periods of time were derived from the
following dates:
    1. The date an exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (the act) (21 U.S.C. 355(i)) became effective:
May 19, 1999. FDA has verified the applicant's claim that the date the
investigational new drug application became effective was on May 19,
1999.
    2. The date the application was initially submitted with respect to
the human drug product under section 505(b) of the act: September 28,
2007. FDA has verified the applicant's claim that the new drug
application (NDA 22-253) for VIMPAT tablets was submitted on September
28, 2007.
    3. The date the application was approved: October 28, 2008. FDA has
verified the applicant's claim that NDA 22-253 was approved on October
28, 2008.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the U.S.
Patent and Trademark Office applies several statutory limitations in
its calculations of the actual period for patent extension. In its
application for patent extension, this applicant seeks 1,827 days of
patent term extension.
    Anyone with knowledge that any of the dates as published are
incorrect may submit to the Division of Dockets Management (see
ADDRESSES) written or electronic comments and ask for a redetermination
by June 22, 2010. 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 October 20,
2010. To meet its burden, the petition must contain sufficient facts to
merit an FDA investigation. (See H. Rept. 857, part 1, 98th Cong., 2d
sess., pp. 41-42, 1984.) Petitions should be in the format specified in
21 CFR 10.30.

    Comments and petitions should be submitted to the Division of
Dockets Management. Three copies of any mailed information are to be
submitted, except that individuals may submit one copy. Comments are to
be identified with the docket numbers found in brackets in the heading
of this document.
    Comments and petitions may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: March 22, 2010.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. 2010-9512 Filed 4-22-10; 8:45 am]
BILLING CODE 4160-01-S


                                 Attachment A
          Supporting Documentation for 110(l) and 193 Demonstration
        Georgia Chapter 391-1-22, Georgia's Clean Fueled Fleet Rules

Federal Regulations And The Ozone Nonattainment Area

The Clean Fuel Fleet Program (CFFP) is a requirement of section 182(c)(4) of the CAA  for areas that have been designated serious nonattainment or above for the ozone National Ambient Air Quality Standards (NAAQS).  CFFP is listed as an applicable requirement in 40 CFR 51.900(f) (as well as in the proposed list of applicable requirements in 40 CFR 51.1100(o)). The Atlanta area was previously classified as severe for the previous 1-hour ozone NAAQS.  The area was re-designated as attainment on June 15, 2005 [70FR 34660].  The Atlanta area was subsequently designated as nonattainment and classified as moderate for the 1997 8-hour ozone NAAQS.  The Atlanta area was re-designated as attainment for the 1997 standard on December 2, 2013 [78FR 72040], prior to revocation of that standard.  The Atlanta area is currently classified as a marginal nonattainment area for the 2008 8-hour ozone NAAQS
[73 FR 16483].

In addition, the currently proposed rule for the "Implementation of the 2008 National Ambient Air Quality Standards for Ozone:  State Implementation Plan Requirements" [78FR 34178] proposes to replace the current anti-backsliding requirements by amending 40 CFR Part 51 Subpart AA to address both the previously revoked 1-hour ozone NAAQS and the 1997 8-hour ozone NAAQS.  The proposed anti-backsliding provisions for areas that are designated nonattainment for the 2008 NAAQS and attainment/maintenance for previous NAAQS are summarized in Table 2-2008 Ozone NAAQS Transition Obligations of the proposal as follows: "Area remains subject to existing section 175A maintenance plan for the previous NAAQS and requirements already in the SIP, subject to revision consistent with sections 110(l) and 193."

As indicated in the transmittal letter, 40 CFR 51.905(b) addresses state anti-backsliding requirements regarding implementation of applicable requirements after an area attains the 8-hour ozone NAAQS as follows: "A State remains subject to the obligations under paragraphs (a)(1)(i) and (a)(2) of this section until the area attains the 8-hour NAAQS.  After the area attains the 8-hour NAAQS, the State may request such obligations be shifted to contingency measures, consistent with sections 110(l) and 193 of the CAA..."

Because the Atlanta area has attained the 1997 ozone NAAQS prior to revocation of that standard, Georgia's Clean Fueled Fleet Rules may be shifted to contingency measures, consistent with sections 110(l) and 193 of the CAA.  Section 193 is a general savings clause pertaining to regulations, standards, rules, notices, orders, and guidance promulgated or issued prior to November 15, 1990.  CFFF was effective on May 22, 1994. Therefore, the substantive CAA provision EPD will demonstrate compliance with in this demonstration is that of section 110(l).

Georgia Chapter 391-1-22, Clean Fuel Fleets Program

The Clean Fueled Fleets (CFF) Rules require that a percentage of a covered fleet's covered vehicle purchases must meet the clean fueled fleet (low emission) vehicle standards.  Covered fleets included any public or private fleet that operated 10 or more covered vehicles in a covered area, which for Georgia only included 13 counties around metro-Atlanta.  Covered vehicles included light duty vehicles up to heavy-duty vehicles with a gross vehicle weight rating (GVWR) of 26,000 lbs that were or were capable of being centrally fueled. Table 1 below lists each of the vehicle emission classifications.  Acronyms in Table 1 are displayed at the bottom of the table. The program included a number of exemptions for various categories including vehicles garaged at a personal residence and not centrally fueled.  Law enforcement and emergency vehicles were other popular exempt categories.  The program for light duty vehicles was phased in from 1999 to 2001 with 30% of covered purchases having to meet the low emission vehicle (LEV) standards in 1999, 50% in 2000, and 70% in 2001.  The percentage requirements remain at 70% for 2002 and after.  Heavy-duty vehicle purchases had to meet a 50% requirement beginning with the 1999 model year, and the percentage remained the same for each subsequent model year. The CFFP started in 1999 with 612 covered fleets.  This number dwindled down to 345 as of 2007.  The overwhelming reason for this decline was the result of fleets understanding the "garaged at a personal residence and not centrally fueled" exemption and applying it.

The U.S. Environmental Protection Agency (EPA) implemented the Tier II Light Duty Vehicle, Light Duty Truck, and medium-duty passenger vehicle standards for model year 2004 and later vehicles.  These standards were fully phased in by model year 2009.  The Tier II standards are presented in 40 CFR Part 86 Subpart S, particularly in 86.1811-04, 86.1811-09, and 86.1811-10.  The Tier II standards are more stringent than the low emission vehicle (LEV) standards in the Clean Fueled Fleets Rules.  These standards apply to all of the light-duty vehicle and light duty truck vehicle categories under the CFF Rule.  EPA implemented new engine standards for heavy-duty diesel engines with a GVWR greater than 8500lbs beginning with the 2004 model year.  These standards are more stringent than the LEV standards in the CFF Rules.  The heavy-duty engine standards are presented in 40 CFR Part 86 Subpart S, particularly in 86.1816-05, 86.1816-08, 86.005-10, 86.008-10, 86.004-11, and 86.007-11.  Other sections within Subpart S cover the light duty Tier III standards, which provide even lower standards.

Equivalency Demonstration

In the Clean Fueled Fleets rule, covered fleets are required to purchase clean fueled vehicles (CFVs), which at a minimum must meet the low emission vehicle (LEV) standards.  The U.S. Environmental Protection Agency (EPA) implemented the light duty vehicle Tier II and new heavy-duty diesel engine standards in 2004.  Both of these standards reduce tailpipe emission standards significantly over the LEV standards.

Georgia EPD analyzed the annual reports submitted for model years 2001  -  2004 and 2006 to determine the number of used vehicles purchased and the range of the model years.  EPD determined that 98% of vehicle purchases are new.  Only 2% of vehicles are purchased as used.  Out of the used vehicles purchased, 80% would be 2004 and newer models.  As a result, only 0.4% of vehicles purchased are 11 years or older.  Since only, 30% of light duty and 50% of heavy-duty covered vehicle purchases are required to be clean fueled vehicles (CFVs), these used vehicles would not be required to be LEVs.

The Tier II standards were fully implemented in model year 2009.  The table below illustrates the emission benefit of the Tier II and heavy-duty engine standards over LEV standards. The emission standards for Tier II in the table represent the 2009 model year and later (fully phased in).  Although even more stringent heavy-duty engine standards were implemented by EPA in 2007 and fully phased in by 2010, the table below presents the emission standards as implemented in 2004.

As illustrated in the table, the Tier II NOx standards have a benefit over the LEV standards ranging from 0.09 grams/mile to 0.99 grams/mile.  The 2004 heavy-duty engine standards have a NMHC + NOx benefit of 1.4 grams/bhp-hr. These benefits are on a per vehicle basis. Since all of the Tier II and 2004 heavy-duty engine standards are equivalent or more stringent than the Clean Fuel Fleet standards, the emission reductions from these federal standards surpassed the emission reductions from Georgia Clean Fueled Fleets rules in 2004, when the federal standards were implemented.

EPA has also recognized that the Tier II vehicle and 2004 heavy-duty engine standards are equivalent or more stringent than the clean fueled vehicle (LEV) standards since 2004.  A memo dated July 2, 2004 from EPA, Leila Cook, Group Manager in the Office of Air & Radiation, states:

      "EPA has since published new emission standards that are more stringent than the CFFP standards for heavy-duty diesel and heavy-duty gasoline engines, as well as light duty vehicles. Therefore, vehicles certified to these new standards are considered acceptable for meeting the requirements contained in Part 88 for the Clean Fuel Fleets Program.

      Fleet managers seeking to meet the requirements of the CFFP should be assured that all vehicles manufactured to meet the Tier 2 emission standards are equivalent to or cleaner than earlier emission levels mandated by the CFFP. Therefore, these new Tier 2 vehicles are acceptable for use in meeting the CFFP requirements."

Furthermore, EPA issued a letter to manufacturers on the Clean-Fuel Vehicle Standards on July 21, 2005.  This letter states:

      "To determine equivalency, current certification emission standards for Tier 2 vehicles (LDVs, LDTs, and MDPVs), heavy-duty vehicles, heavy duty Otto cycle engines, and heavy-duty diesel engines were compared to CFV vehicle and engine emission standards using the methodology outlined in the Attachment. The results of this analysis are summarized as follows:

      Tier 2 LDVs, LDT1-4s, and MDPVs certified to the following Tier 2 bin standards are equivalent to or more stringent than CFV LEV emission standards:
      LDV Bins 1-7 and Bin 9
      LDTl Bins 1-7 and Bin 9
      LDT2 Bins 1-9
      LDT3 Bin 1-10
      LDT4 Bin 1-10
      MDPV Bin 1-114"
      [4]There are no CFV emission standards that correspond to the Tier 2 MDPV class but   MDPVs meeting Tier 2 Bins 1-1 1 are all equal to or more stringent than LDT4 CFV LEV standards.

The July 21, 2005 letter further states:

      "The following determinations are made for 2005 and later model year heavy-duty Otto cycle engines and diesel engines: Current emission standards for heavy-duty engine Otto cycle engines and diesel engines are more stringent than CFV LEV heavy-duty Otto cycle engines, or heavy-duty diesel engine emission standards."

Note:  The previously listed Table 1 uses the Tier II emission standards phased in for model year 2009 and later.  As a result, Bins 8, 9, and 10 have been phased out.

EPA sent a memo dated April 17, 2006 to Air Program Managers on the Clean Fuel Fleet Program Requirements.  The purpose of this memo was to provide information sent to manufacturers on determining equivalency between vehicle and engine standards in CFR Part 86 (Tier II & new HD engines) and Part 88 (clean fueled vehicles).  Below is a quote from the memo:

      "To meet the requirements of the Clean Fuel Fleet Program fleet managers can be assured that vehicles and engines certified to current Part 86 emission standards, which EPA has determined to be as or more stringent than corresponding CFV emission standards per the attached EPA Dear Manufacturer Letter meet CFV emission standards and CFFP requirements as defined in CFR Part 88. Such vehicles do not require a separate CFF certification or CFF label to qualify to participate in the CFF program. Thus, such vehicles are CFF compliant and are available to satisfy CFF SIP obligations."

In summary, the Tier II vehicle standards and the 2004 heavy-duty diesel engine standards are clearly equivalent or more stringent than the low emission (clean fuel) vehicle standards.  The emission standards taken from 40 CFR Part 86 in Table 1 illustrate that the Tier II and 2004 heavy-duty engine standards provide significant emission benefits over the low emission vehicle standard.  These three EPA memos have been included in this submittal as Appendix B, and further clarify that EPA agrees that the Tier II and 2004 heavy-duty engine standards are more stringent. As a result the existing EPA light duty and heavy duty emission standards can easily replace the requirements and benefits of the Clean Fueled Fleets Rule.

Conclusion

The Georgia Environmental Protection Division (EPD) is submitting for approval and incorporation, this proposed revision to Georgia's State Implementation Plan (SIP), a request to remove its Clean Fueled Fleet Rules, Chapter 391-1-22, of the Georgia Rules to its contingency measures, in a manner consistent with the requirements of 110(ℓ) and EPA's proposed anti-backsliding provisions.

Section 110(ℓ) of the CAA, governs EPA's ability to approve all SIP revisions.  Specifically, section 110(ℓ) states:

  Each revision to an implementation plan submitted by a State under this chapter shall be adopted by such State after reasonable notice and public hearing. The Administrator shall not approve a revision of a plan if the revision would interfere with any applicable requirement concerning attainment and reasonable further progress (as defined in section 171 of this title), or any other applicable requirement of this chapter.

As shown in the equivalency demonstration, given that the Tier II vehicle standards and the 2004 heavy-duty diesel engine standards are clearly more equivalent or more stringent than the low emission (clean fuel) vehicle standards, the removal of CFFP will not interfere with attainment or reasonable further progress, or any other applicable requirement of the act, EPD can assert that by moving this measure to contingency, this action is consistent with the requirements of 110(l) of the act as well as EPA's proposed anti-backsliding provisions.

Since the federal Tier II and 2004 heavy-duty diesel engine standards were more stringent than the CFFP standards as soon as the federal standards were implemented and since covered fleet owners were required to comply with both the CFFP and the federal standards, there was no, nor will there ever be, a shortfall in emissions reductions as a result of revocation of Georgia's Clean Fueled Fleet Rules in 2014,  Therefore, no substitute measure is required for the revocation of Georgia's Clean Fueled Fleets rules.