[Federal Register Volume 76, Number 70 (Tuesday, April 12, 2011)]
[Notices]
[Pages 20357-20358]
[FR Doc No: 2011-8617]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-P-0256]

Determination That KEFLEX (Cephalexin) Capsule, Equivalent to 333
Milligrams Base, Was Not Withdrawn From Sale for Reasons of Safety or
Effectiveness

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) has determined that
KEFLEX (cephalexin) capsule, equivalent to (EQ) 333 milligrams (mg)
base, was not withdrawn from sale for reasons of safety or
effectiveness. This determination will allow FDA to approve abbreviated
new drug applications (ANDAs) for cephalexin capsule, EQ 333 mg base,
if all other legal and regulatory requirements are met.

FOR FURTHER INFORMATION CONTACT:  Patrick Raulerson, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6368, Silver Spring, MD 20993-0002, 301-
796-3522.

SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price
Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417)
(the 1984 amendments), which authorized the approval of duplicate
versions of drug products approved under an ANDA procedure. ANDA
applicants must, with certain exceptions, show that the drug for which
they are seeking approval contains the same active ingredient in the
same strength and dosage form as the ``listed drug,'' which is a
version of the drug that was previously approved. ANDA applicants do
not have to repeat the extensive clinical testing otherwise necessary
to gain approval of a new drug application (NDA). The only clinical
data required in an ANDA are data to show that the drug that is the
subject of the ANDA is bioequivalent to the listed drug.
    The 1984 amendments include what is now section 505(j)(7) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which
requires FDA to publish a list of all approved drugs. FDA publishes
this list as part of the ``Approved Drug Products With Therapeutic
Equivalence Evaluations,'' which is known generally as the ``Orange
Book.'' Under FDA regulations, a drug is removed from the list if the
Agency withdraws or suspends approval of the drug's NDA or ANDA for
reasons of safety or effectiveness or if FDA determines that the listed
drug was withdrawn from sale for reasons of safety or effectiveness (21
CFR 314.162). Under Sec.  314.161(a)(1) (21 CFR 314.161(a)(1)), the
Agency must determine whether a listed drug was withdrawn from sale for
reasons of safety or effectiveness before an ANDA that refers to that
listed drug may be approved. FDA may not approve an ANDA that does not
refer to a listed drug.
    KEFLEX (cephalexin) capsule, EQ 333 mg base, is the subject of NDA
050405 held by Victory Pharma, Inc., and the 333-mg strength was
approved on May 12, 2006. KEFLEX is a cephalosporin antibiotic
indicated for the treatment of respiratory tract infections caused by
Streptococcus pneumoniae and S. pyogenes, as well as certain other
infections caused by susceptible strains of certain designated micro-
organisms as described in the product labeling.
    KEFLEX (cephalexin) capsule, EQ 333 mg base, has never been
marketed. In previous instances (see 72 FR 9763, March 5, 2007; 61 FR
25497, May 21, 1996), the Agency has determined that, for purposes of
Sec. Sec.  314.161 and 314.162, never marketing an approved drug
product is equivalent to withdrawing the drug from sale.
    Lachman Consultant Services, Inc., submitted a citizen petition
dated May 29, 2009 (Docket No. FDA-2009-P-0256), under 21 CFR 10.30,
requesting that the Agency determine whether KEFLEX (cephalexin)
capsule, EQ 333 mg base, was withdrawn from sale for reasons of safety
or effectiveness. After considering the citizen petition and reviewing
Agency records, FDA has determined under Sec.  314.161 that KEFLEX
(cephalexin) capsule, EQ 333 mg base, was not withdrawn for reasons of
safety or effectiveness. The petitioner has identified no data or other
information suggesting that KEFLEX (cephalexin) capsule, EQ 333 mg
base, was withdrawn for reasons of safety or effectiveness. We have
carefully reviewed our files for records concerning the withdrawal of
KEFLEX (cephalexin) capsule, EQ 333 mg base, from sale. We have also
independently evaluated relevant literature and data for possible
postmarketing adverse events. We have found no information

that would indicate that this product was withdrawn from sale for
reasons of safety or effectiveness.
    Accordingly, the Agency will continue to list KEFLEX (cephalexin)
capsule, EQ 333 mg base, in the ``Discontinued Drug Product List''
section of the Orange Book. The ``Discontinued Drug Product List''
delineates, among other items, drug products that have been
discontinued from marketing for reasons other than safety or
effectiveness. ANDAs that refer to KEFLEX (cephalexin) capsule, EQ 333
mg base, may be approved by the Agency as long as they meet all other
legal and regulatory requirements for the approval of ANDAs. If FDA
determines that labeling for this drug product should be revised to
meet current standards, the Agency will advise ANDA applicants to
submit such labeling.

    Dated: April 6, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-8617 Filed 4-11-11; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register: June 6, 2007 (Volume 72, Number 108)]
[Notices]
[Page 31307]
[DOCID:fr06jn07-63]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP07-464-000]

High Island Offshore System L.L.C.; Notice of Tariff Filing

May 31, 2007.
    Take notice that on May 25, 2007, High Island Offshore System
L.L.C. (HIOS) tendered for filing as part of its FERC Gas Tariff, Third
Revised Volume No. 1, Fourth Revised Sheet No. 1 and Second Revised
Sheet No. 12, effective January 1, 2007.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211 and 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed in accordance with the provisions of
Section 154.210 of the Commission's regulations (18 CFR 154.210).
Anyone filing an intervention or protest must serve a copy of that
document on the Applicant. Anyone filing an intervention or protest on
or before the intervention or protest date need not serve motions to
intervene or protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov.
 Persons unable to file electronically should submit an

original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the

``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For

TTY, call<PHONE_NUMBER>.

Kimberly D. Bose,
Secretary.
 [FR Doc. E7-10843 Filed 6-5-07; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register: December 28, 2007 (Volume 72, Number 248)]
[Notices]
[Page 73968-73969]
[DOCID:fr28de07-216]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

Petition for a Waiver of Compliance

    In accordance with Title 49 Code of Federal Regulations (CFR)
Sec. Sec.  211.9 and 211.41, notice is hereby given that the Federal
Railroad Administration (FRA) received a request for a waiver of
compliance with certain requirements of its safety standards. The
individual petition is described below, including the party seeking
relief, the regulatory provisions involved, the nature of the relief
being requested, and the petitioner's arguments in favor of relief.

Canadian Pacific Railway

[Waiver Petition Docket Number FRA-2007-0008]

    The Canadian Pacific Railway (CP) seeks a waiver from the
requirements of 49 CFR 240.117(e)(1) through (4), 240.305, and 240.307,
in connection with implementation of a Close Call Reporting System
(C3RS) Demonstration Pilot Project (Pilot Project) sponsored by FRA's
Office of Research and Development. These sections of the regulation
relate to punitive actions that are required to be taken against
locomotive engineers for the violation of certain railroad operating
rules. Refer to Part 240 for a detailed listing of these sections.
    CP and the employees of CP's Chicago Service Area, represented by
the Brotherhood of Locomotive Engineers and Trainmen (BLET) and the
United Transportation Union (UTU), desire to participate in the Pilot
Project, which is one of the action items included in FRA's Action Plan
for Addressing Critical Railroad Safety Issues (Action Plan) announced
on January 25, 2006.
    As noted in the Action Plan, in other industries such as aviation
and mining, as well as in the European railway industry, implementation
of ``close call'' reporting systems that shield the reporting employee
from discipline (and the employer from punitive sanctions levied by the
regulation) have contributed to major reductions in accidents. In March
of 2005, FRA completed an overarching memorandum of understanding with
railroad labor organizations and management to develop pilot programs
to document close calls, i.e., unsafe events that do not result in a
reportable accident but very well could have. Participating railroads
will be expected to develop corrective actions to address the problems
that may be revealed. The aggregate data may prove useful in FRA's
decision-making concerning regulatory and other options to address
human factor-caused accidents.
    CP, BLET, and UTU have developed and signed an implementing
memorandum of understanding (IMOU), based on the FRA's overarching
memorandum of understanding, as a first step in commencing the
demonstration pilot project. The project would involve approximately
350 yard and road service employees operating between Newport,
Minnesota, (Mile Post (MP) 402.5C, River Subdivision) and Tower A-20
(MP 20.5, C&M Subdivision), and all track between those mileposts,
including track on the following subdivisions: River, Tomah, Watertown,
M&P, the CN Valley, and C&M. This IMOU was sent to FRA for
consideration and acceptance on October 8, 2007. As referenced in the
IMOU, certain ``close calls'' may be properly reported by the
employee(s) involved and later discovered by CP, for example, through
subsequent retrospective analysis of locomotive event recorder data,
etc. In order to encourage employee reporting of close calls, the IMOU
contains provisions to shield the reporting employee from CP
discipline. CP, BLET, and UTU also desire to shield the reporting
employee(s) and CP from punitive sanctions that would otherwise arise
as provided in selected sections of Part 240 for properly reported
close call events as defined in the C3RS IMOU.
    The waiver petition is requested for the duration of the C3RS Pilot
Project (5 years from implementation or until the Pilot Project is
completed or parties to the IMOU withdraw as described in the IMOU,
whichever comes first).

    Note: According to Article 7.2 of the IMOU, ``Conditions under
which a reporting employee is not protected from CP discipline and/
or decertification and from FRA enforcement,'' CP employees included
in this C3RS/IMOU receive no protection from discipline and/or
decertification or from FRA enforcement action when one or more of
the following conditions occur:

     The employee's action or lack of action was intended to
damage CP or another entity's operations or equipment, or to injure
other individuals or purposely place others in danger (e.g.,
sabotage);
     The employee's action or lack of action involved a
criminal offense;
     The employee's behavior involved substance abuse or
inappropriate use of controlled substances;
     The report is rejected by the Bureau of Transportation
Statistics Peer Review Team;
     The event resulted in a railroad accident/incident that
qualifies as reportable under Sec.  225.11;
     The event resulted in an identifiable release of a
hazardous material; or
     The event was observed in real-time and reported to CP
management (such as a train dispatcher or operator observing a
signal violation) or was observed as part of proficiency testing.

    Proficiency testing (e.g., operating rule efficiency testing,
signal compliance testing) generally consists of real-time observations
and do not qualify for exemption. Similarly, an employee is not exempt
from discipline and/or decertification for a violation that CP or FRA
identifies contemporaneously (e.g., a block circuit is occupied by a
train without authority, and the train dispatcher notices it before the
train backs off the circuit) before the employee files a close call
report. In such situations, CP or FRA may use event recorder
information to support discipline and/or decertification and/or
enforcement. For example, a CP official who observes a train operate
past a signal that requires a stop may use any relevant data recorded
by the locomotive's event recorder in pursuing disciplinary action
against the train crew, regardless of whether a member of the crew
timely files a close call report.
    In its petition, CP indicated that the parties signatory to the
IMOU, dated August 21, 2007, believe the data from these properly
reported close call incidents, as defined in the IMOU, will be
invaluable in the analysis and development of effective corrective
actions. CP expressed the view that without the requested waiver the
employee(s) involved in incidents such as those described above will
not file reports of the incidents and that the incident(s) will likely
go undetected, resulting in no opportunity for analysis, data trending,
or appropriate corrective actions. Noting the success of close call
reporting systems in other industries (e.g., aviation and maritime), CP
further indicated that all parties signatory to the IMOU and
participating in the Pilot Project believe that the Pilot Project and
requested regulatory relief is in the public interest and consistent
with railroad safety.
    Interested parties are invited to participate in these proceedings
by submitting written views, data, or comments. FRA does not anticipate
scheduling a public hearing in connection with these proceedings since
the facts do not appear to warrant a hearing. If any interested party
desires an opportunity for oral comment, they

should notify FRA in writing, before the end of the comment period and
specify the basis for their request.
    All communications concerning these proceedings should identify the
appropriate docket number (e.g., Waiver Petition Docket Number FRA-
2007-0008) and may be submitted by any of the following methods:
     Web site: http://www.regulations.gov. Follow the online

instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: Docket Operations Facility, U.S. Department of
Transportation, 1200 New Jersey Avenue, SE., W12-140, Washington, DC
20590.
     Hand Delivery: 1200 New Jersey Avenue, SE., Room W12-140,
Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays.
    Communications received within 45 days of the date of this notice
will be considered by FRA before final action is taken. Comments
received after that date will be considered as far as practicable. All
written communications concerning these proceedings are available for
examination during regular business hours (9 a.m.-5 p.m.) at the above
facility. All documents in the public docket are also available for
inspection and copying on the Internet at the docket facility's Web
site at http://www.regulations.gov.

    Anyone is able to search the electronic form of any written
communications and comments received into any of our dockets by the
name of the individual submitting the comment (or signing the comment,
if submitted on behalf of an association, business, labor union, etc.).
You may review DOT's complete Privacy Act Statement in the Federal
Register published on April 11, 2000 (Volume 65, Number 70; Pages
19477-78).

    Issued in Washington, DC, on December 19, 2007.
Grady C. Cothen, Jr.,
Deputy Associate Administrator for Safety Standards and Program
Development.
[FR Doc. E7-25141 Filed 12-27-07; 8:45 am]

BILLING CODE 4910-06-P


[Federal Register: September 19, 2008 (Volume 73, Number 183)]
[Notices]
[Page 54414-54415]
[DOCID:fr19se08-69]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[FEMA-3295-EM]

Louisiana; Emergency and Related Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This is a notice of the Presidential declaration of an
emergency for the State of Louisiana (FEMA-3295-EM), dated September
11, 2008, and related determinations.

DATES: Effective Date: September 11, 2008.

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

SUPPLEMENTARY INFORMATION: Notice is hereby given that, in a letter
dated September 11, 2008, the President declared an emergency under the
authority of the Robert T. Stafford Disaster Relief and Emergency
Assistance Act, 42 U.S.C. 5121-5207 (the Stafford Act), as follows:

    I have determined that the emergency conditions in the State of
Louisiana resulting from Hurricane Ike beginning on September 7,
2008, and continuing, are of sufficient severity and magnitude to
warrant an emergency declaration under the Robert T. Stafford
Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121-5206
(the Stafford Act). Therefore, I declare that such an emergency
exists in the State of Louisiana.
    You are authorized to provide appropriate assistance for
required emergency measures, authorized under Title V of the
Stafford Act, to save lives, protect property and public health and
safety, or to lessen or avert the threat of a catastrophe in the
designated areas. Specifically, you are authorized to provide
assistance for emergency protective measures (Category B), including
direct

Federal assistance, under the Public Assistance program. This
assistance excludes regular time costs for subgrantees' regular
employees. In addition, you are authorized to provide such other
forms of assistance under Title V of the Stafford Act as you may
deem appropriate.
    Consistent with the requirement that Federal assistance be
supplemental, any Federal funds provided under the Stafford Act for
Public Assistance will be limited to 75 percent of the total
eligible costs. In order to provide Federal assistance, you are
hereby authorized to allocate from funds available for these
purposes such amounts as you find necessary for Federal emergency
assistance and administrative expenses.
    Further, you are authorized to make changes to this declaration
to the extent allowable under the Stafford Act.

    The Federal Emergency Management Agency (FEMA) hereby gives notice
that pursuant to the authority vested in the Administrator, Department
of Homeland Security, under Executive Order 12148, as amended, Michael
J. Hall, of FEMA is appointed to act as the Federal Coordinating
Officer for this declared emergency.
    The following areas of the State of Louisiana have been designated
as adversely affected by this declared emergency:

    Calcasieu, Cameron, Jefferson Davis, and Vermilion Parishes for
emergency protective measures (Category 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.)

R. David Paulison,
Administrator, Federal Emergency Management Agency.
[FR Doc. E8-21935 Filed 9-18-08; 8:45 am]

BILLING CODE 9110-10-P


[Federal Register Volume 84, Number 34 (Wednesday, February 20, 2019)]
[Notices]
[Pages 5073-5074]
[FR Doc No: 2019-02828]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 2808-000]

KEI (Maine) Power Management (III) LLC; Notice of Authorization
for Continued Project Operation

    On January 30, 2017, KEI (Maine) Power Management (III) LLC,
licensee for the Barker's Mill Hydroelectric Project, filed an
Application for a New License pursuant to the Federal Power Act (FPA)
and the Commission's regulations thereunder. The Barker's Mill
Hydroelectric Project is located on the Little Androscoggin River, in
the City of Auburn, Androscoggin County, Maine.
    The license for Project No. 2808 was issued for a period ending
January 31, 2019. Section 15(a)(1) of the FPA, 16 U.S.C. 808(a)(1),
requires the Commission, at the expiration of a license term, to issue
from year-to-year an annual license to the then licensee under the
terms and conditions of the prior license until a new license is
issued, or the project is otherwise disposed of as provided in section
15 or any other applicable section of the FPA. If the project's prior
license waived the applicability of section 15 of the FPA, then, based
on section 9(b) of the Administrative Procedure Act, 5 U.S.C. 558(c),
and as set forth at 18 CFR 16.21(a), if the licensee of such project
has filed an application for a subsequent license, the licensee may
continue to operate the project in accordance with the terms and
conditions of the license after the minor or minor part license
expires, until the Commission acts on its application. If the licensee
of such a project has not filed an application for a subsequent
license, then it may be required, pursuant to 18 CFR 16.21(b), to
continue project operations until the Commission issues someone else a
license for the project or otherwise orders disposition of the project.
    If the project is subject to section 15 of the FPA, notice is
hereby given that an annual license for Project No. 2808 is issued to
the licensee for a period effective February 1, 2019 through January
31, 2020, or until the issuance of a new license for the project or
other disposition under the FPA, whichever comes first. If issuance of
a new license

(or other disposition) does not take place on or before January 31,
2020, notice is hereby given that, pursuant to 18 CFR 16.18(c), an
annual license under section 15(a)(1) of the FPA is renewed
automatically without further order or notice by the Commission, unless
the Commission orders otherwise.
    If the project is not subject to section 15 of the FPA, notice is
hereby given that the licensee, KEI (Maine) Power Management (III)
LLC., is authorized to continue operation of the Barker's Mill
Hydroelectric Project until such time as the Commission acts on its
application for a subsequent license.

    Dated: February 13, 2019.
Kimberly D. Bose,
Secretary.
[FR Doc. 2019-02828 Filed 2-19-19; 8:45 am]
 BILLING CODE 6717-01-P


UNITED STATES OF AMERICA

DEPARTMENT OF TRANSPORTATION

OFFICE OF THE SECRETARY

WASHINGTON, DC

Issued by the Department of Transportation on April 5 2006

NOTICE OF ACTION TAKEN -- DOCKET OST-2006-24220

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).

Application of ATLANTIC SOUTHEAST AIRLINES, INC. (ASA), filed 3/15/06,
for:

XX	Exemption for two years under 49 U.S.C. 40109 to provide the
following service:

Scheduled foreign air transportation of persons, property, and mail
between a point or points in the United States and a point or points in
Canada, and to combine this exemption authority with its existing
certificate and exemption authority.  ASA plans to provide nonstop
“Delta Connection” service under the Delta Air Lines code, DL*,
between Atlanta, Georgia, and Toronto, Canada using a 70-seat CRJ 700
aircraft.

Applicant rep: Alexander Van der Bellen,<PHONE_NUMBER>	DOT Analyst:
Tretha Chromey<PHONE_NUMBER>

D I S P O S I T I O N

XX	Granted (subject to conditions, see below)

The above action was effective when taken: April 5, 2006 through April
5, 2008.

Action taken by:	Paul L. Gretch, Director

Office of International Aviation

XX The authority granted is consistent with the aviation agreement
between the United States and Canada.

Except to the extent exempted or waived, this authority is subject to
the terms, conditions, and limitations indicated:	XX Holder’s
certificates of public convenience and necessity

XX Standard exemption conditions (attached)

Conditions:  The route integration authority granted is subject to the
condition that any service provided under this exemption shall be
consistent with all applicable agreements between the United States and
the foreign countries involved.  Furthermore, (a) nothing in the award
of the route integration authority requested should be construed as
conferring upon ASA rights (including fifth-freedom intermediate and/or
beyond rights) to serve markets where U.S. carrier entry is limited
unless ASA notifies the Department of its intent to serve such a market
and unless and until the Department has completed any necessary carrier
selection procedures to determine which carrier(s) should be authorized
to exercise such rights; and (b) should there be a request by any
carrier to use the limited-entry route rights that are included in
ASA’s authority by virtue of the route integration exemption granted
here, but that are not then being used by ASA, the holding of such
authority by route integration will not be considered as providing any
preference for ASA in a competitive carrier selection proceeding to
determine which carrier(s) should be entitled to use the authority at
issue.

The code-share operations conducted under this authorization are subject
to the following conditions: (a) the code-sharing operations conducted
under this authority must comply with 14 CFR 257 and with any amendment
to the Department’s regulations concerning code-share arrangements
that may be adopted.  Notwithstanding any provisions in the contract
between the carriers, our approval here is expressly conditioned upon
the requirements that the subject foreign air transportation be sold in
the name of the carrier holding out such service in computer reservation
systems and elsewhere; that the carrier selling such transportation
(i.e., the carrier shown on the ticket) accept responsibility for the
entirety of the code-share journey for all obligations established in
its contract of carriage with the passenger; and that the passenger
liability of the operating carrier be unaffected; and (b) the authority
granted here is specifically conditioned so that neither ASA nor Delta
shall give any force or effect to any contractual provisions between
themselves that are contrary to these conditions.

On the basis of data officially noticeable under Rule 24(g) of the
Department’s regulations, we found the applicant qualified to provide
the services authorized.

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, 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/report_aviation.asp

U.S. Carrier Exemption Conditions

In the conduct of the operations authorized, the U.S. carrier
applicant(s) shall:

(1)  Hold at all times effective operating authority from the government
of each country served;

(2)  Comply with applicable requirements concerning oversales contained
in 14 CFR 250 (for scheduled operations, if authorized);

(3)  Comply with the requirements for reporting data contained in 14 CFR
241;

(4)  Comply with requirements for minimum insurance coverage, and for
certifying that coverage to the Department, contained in 14 CFR 205;

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

(6)  Comply with all applicable requirements of the Federal Aviation
Administration and with all applicable U.S. Government requirements
concerning security, including, but not limited to, 49 CFR Part 1544.
To assure compliance with all applicable U.S. Government requirements
concerning security, the holder shall, before commencing any new service
(including charter flights) to or from a foreign airport, contact its
International Principal Security Inspector (IPSI) to advise the IPSI 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; and

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

The authority granted shall be effective only during the period when the
holder is in compliance with the conditions imposed above.

05/2004

 ASA states that it needs this exemption authority to upgrade from its
current aircraft of fewer than 60-seats to 70-seat CRJ-700 aircraft to
have the flexibility to introduce additional U.S.-Canada service.


[Federal Register Volume 83, Number 246 (Wednesday, December 26, 2018)]
[Proposed Rules]
[Pages 66196-66197]
[FR Doc No: 2018-27905]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R05-OAR-2018-0103; FRL-9988-24-Region 5]

Air Plan Approval; Ohio; Removal of Obsolete Gasoline Volatility
Regulations

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: The Environmental Protection Agency (EPA) is proposing to
approve a request submitted by the Ohio Environmental Protection Agency
(Ohio EPA) on February 5, 2018, to revise the Ohio State Implementation
Plan (SIP) under the Clean Air Act (CAA). Ohio EPA is requesting to
remove from the SIP the remaining provisions of the Ohio Administrative
Code concerning the State's former 7.8 pounds per square inch (psi)
Reid vapor pressure (RVP) fuel requirements for the Cincinnati and
Dayton areas. In a previous action, EPA approved the removal of the 7.8
psi RVP fuel applicability requirements in the Cincinnati and Dayton
areas as a component of the Ohio SIP, including the approval of a
demonstration under section 110(l) of the Clean Air Act (CAA) that
addressed emissions impacts associated with the removal of the program.

DATES: Comments must be received on or before January 25, 2019.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R05-
OAR-2018-0103 at http://www.regulations.gov, or via email to
<EMAIL_ADDRESS>For comments submitted at Regulations.gov,
follow the online instructions for submitting comments. Once submitted,
comments cannot be edited or removed from Regulations.gov. For either
manner of submission, EPA may publish any comment received to its
public docket. Do not submit electronically any information you
consider to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute. Multimedia
submissions (audio, video, etc.) must be accompanied by a written
comment. The written comment is considered the official comment and
should include discussion of all points you wish to make. EPA will
generally not consider comments or comment contents located outside of
the primary submission (i.e. on the web, cloud, or other file sharing
system). For additional submission methods, please contact the person
identified in the For Further Information Contact section. For the full
EPA public comment policy, information about CBI or multimedia
submissions, and general guidance on making effective comments, please
visit http://www2.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: Francisco J. Acevedo, Mobile Source
Program Manager, 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 the background for this action?
II. What is EPA proposing to approve?
III. What is EPA's analysis of the state's submittal?
IV. What action is EPA proposing to take?
V. Statutory and Executive Order Reviews

I. What is the background for this action?

    On April 15, 2004, EPA designated Hamilton, Butler, Clinton, Warren
and Clermont counties (Cincinnati area) and Clark, Greene, Miami, and
Montgomery counties (Dayton area) as nonattainment for the 8-hour ozone
standard. As part of Ohio's efforts to bring these areas into
attainment of the ozone standard, the State adopted and implemented a
broad range of ozone control measures for the areas including the
implementation of a 7.8 psi RVP fuel program that was more stringent
than the Federal 9.0 psi RVP requirement. The Ohio EPA originally
submitted a SIP revision to EPA (on

February 14, 2006 and October 6, 2006) establishing a gasoline RVP
limit of 7.8 psi for gasoline sold in the Cincinnati and Dayton areas.
The revision specifically applied to the Cincinnati and Dayton areas in
Ohio. EPA approved Ohio's 7.8 psi RVP program on May 25, 2007 (72 FR
29269), including the program's legal authority and administrative
requirements found in the Ohio Administrative Code (OAC) rules 3745-72-
1 to 8.
    On December 19, 2016, Ohio EPA submitted a SIP revision requesting
that EPA approve the removal of the 7.8 psi RVP fuel applicability
requirements from the Ohio SIP before the beginning of the 2017 ozone
control period. The revision also included a section 110(l)
demonstration addressing the emissions impacts associated with the
removal of the program. On April 7, 2017 (82 FR 16932) EPA approved the
removal of the 7.8 psi RVP fuel applicability requirements in the
Cincinnati and Dayton areas from the Ohio SIP. In that action EPA
determined that that removal of the 7.8 psi RVP fuel requirements would
not interfere with attainment or maintenance of any of the National
Ambient Air Quality Standards in the Cincinnati and Dayton areas and
would not interfere with any other applicable requirement of the CAA,
and thus, were approvable under CAA section 110(l).

II. What is EPA proposing to approve?

    On February 5, 2018, Ohio EPA submitted to EPA a revision to the
Ohio SIP for approval. In this action EPA is proposing to approve the
removal of all OAC Chapter 3745-72 provisions from the Ohio SIP, as
requested. Ohio EPA conducted a public hearing on this matter in
Columbus, Ohio on December 7, 2017.

III. What is EPA's analysis of the state's submittal?

    On January 20, 2018, Ohio EPA rescinded rules in OAC 3745-72 that
formerly established low RVP fuel requirements for the Cincinnati and
Dayton areas. These rules were rescinded by Ohio EPA as they are no
longer necessary since on April 7, 2017 (82 FR 16932) EPA approved the
removal of the 7.8 psi RVP fuel applicability requirements in the
Cincinnati and Dayton areas from the Ohio ozone SIP. In that action EPA
determined that that removal of the 7.8 psi RVP fuel requirements would
not interfere with attainment or maintenance of any of the National
Ambient Air Quality Standards in the Cincinnati and Dayton areas and
would not interfere with any other applicable requirement of the CAA,
and thus, were approvable under CAA section 110(l). The removal of the
remaining provisions in OAC Chapter 3745-72 from the SIP is only
administrative in nature and does not have any negative impact on air
quality in the Cincinnati and Dayton areas. No emissions increases will
result from the removal of the OAC Chapter 3745-72 provisions from the
Ohio SIP.

IV. What action is EPA proposing to take?

    EPA is proposing to approve the revision to the Ohio SIP submitted
by the Ohio EPA on February 5, 2018, because the removal of remaining
low RVP requirements in OAC Chapter 3745-72 from the SIP meets all
applicable requirements and it would not interfere with reasonable
further progress or attainment of any of the national ambient air
quality standards.

V. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the 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 Orders
12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21,
2011);
     Is not an Executive Order 13771 (82 FR 9339, February 2,
2017) regulatory action because SIP approvals are exempted under
Executive Order 12866;
     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, the SIP is not approved to apply on any Indian
reservation land or in any other area where EPA or an Indian tribe has
demonstrated that a tribe has jurisdiction. In those areas of Indian
country, the rule does not have tribal implications and will not impose
substantial direct costs on tribal governments or preempt tribal law as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000).

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Nitrogen oxides, Ozone,
Volatile organic compounds.

    Dated: December 6, 2018.
Cathy Stepp,
Regional Administrator, Region 5.
[FR Doc. 2018-27905 Filed 12-21-18; 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 April 5, 2006

NOTICE OF ACTION TAKEN -- DOCKETS OST-2006-24244

________________________________________________________________________
________________________________________________________

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:  LINEAS AEREAS AZTECA, S.A. de C.V.  (Azteca)
              Date Filed:  March 20, 2006

Relief requested:  Exemption from 49 USC § 41301 to permit the
applicant to conduct scheduled foreign air transportation of persons,
property, and mail between: 1) Hermosillo, Mexico, and Las Vegas,
Nevada; and

2) Tijuana, Mexico, and Oakland, California.

Date and citation of last action:  New authority.

Applicant representative:  Pierre Murphy,<PHONE_NUMBER>            DOT
analyst:  Robert J. Finamore,<PHONE_NUMBER>

Responsive pleadings:  None.

	DISPOSITION

Action:  Approved.					           			 Action date:  April 5, 2006

Effective dates of authority granted:  April 5, 2006, through April 5,
2007.

Basis for approval:  United States-Mexico Air Transport Services
Agreement.

Except to the extent exempted/waived, this authority is subject to the
terms, conditions, and limitations of our standard exemption conditions
(attached).

Action taken by:   Paul L. Gretch, Director, Office of International
Aviation

________________________________________________________________________
_________________________________________________

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) the applicant was qualified to perform its proposed
operations; (3) grant of the authority was consistent with the public
interest; and (4) 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:

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

FOREIGN CARRIER EXEMPTION CONDITIONS
                              ATTACHMENT

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, including, but not limited to, 49 CFR Part 1546 or 1550, as
applicable.  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 International Principal Security Inspector (IPSI) to advise
the IPSI 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.

05/2004


[Federal Register Volume 86, Number 110 (Thursday, June 10, 2021)]
[Notices]
[Pages 30957-30958]
[FR Doc No: 2021-12192]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-E-1895]

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

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 OPTIMIZER 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 medical
device.

DATES: Anyone with knowledge that any of the dates as published (see
SUPPLEMENTARY INFORMATION) are incorrect may submit either electronic
or written comments and ask for a redetermination by August 9, 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 7, 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 9, 2021. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of August 9, 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 No.
FDA-2020-E-1895 for ``Determination of Regulatory Review Period for
Purposes of Patent Extension; OPTIMIZER.'' 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, 240-
402-7500.
     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 medical devices, the testing
phase begins with a clinical investigation of the device and runs until
the approval phase begins. The approval phase starts with the initial
submission of an application to market the device and continues until
permission to market the device is granted. Although only a portion of
a regulatory review period may count toward the actual amount of
extension that the Director of USPTO may award (half the testing phase
must be subtracted as well as any time that may have occurred before
the patent was issued), FDA's determination of the length of a
regulatory review period for a medical device will include all of the
testing phase and approval phase as specified in 35 U.S.C.
156(g)(3)(B).
    FDA has approved for marketing the medical device OPTIMIZER.
OPTIMIZER is indicated to improve 6-minute hall walk distance, quality
of life, and functional status of New York Heart Association Class III
heart failure patients who remain symptomatic despite guideline-
directed medical therapy, are in normal sinus rhythm, are not indicated
for Cardiac Resynchronization Therapy, and have a left ventricular
ejection fraction ranging from 25 percent to 45 percent. Subsequent to
this approval, the USPTO received a patent term restoration application
for OPTIMIZER (U.S. Patent Nos. 8,260,416 and 8,311,629) from Impulse
Dynamics N.V., and the USPTO requested FDA's assistance in determining
this patent's eligibility for patent term restoration. In a letter
dated November 9, 2020, FDA advised the USPTO that this medical device
had undergone a regulatory review period and that the approval of
OPTIMIZER 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
OPTIMIZER is 5,434 days. Of this time, 5,236 days occurred during the
testing phase of the regulatory review period, while 198 days occurred
during the approval phase. These periods of time were derived from the
following dates:
    1. The date an exemption for this device, under section 520(g) of
the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C.
360j(g)), became effective: May 6, 2004. FDA has verified the
applicant's claim that the date the investigational device exemption
for human tests to begin, as required under section 520(g) of the FD&C
Act, became effective May 6, 2004.
    2. The date an application was initially submitted with respect to
the device under section 515 of the FD&C Act (21 U.S.C. 360e):
September 5, 2018. FDA has verified the applicant's claim that the
premarket approval application (PMA) for OPTIMIZER (PMA 180036) was
initially submitted September 5, 2018.
    3. The date the application was approved: March 21, 2019. FDA has
verified the applicant's claim that PMA 180036 was approved on March
21, 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 1,258 days or 1,293 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 3, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-12192 Filed 6-9-21; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: August 24, 2006 (Volume 71, Number 164)]
[Notices]
[Page 50054]
[DOCID:fr24au06-41]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER00-3614-004]

BP Energy Company, BPWest Coast Products LLC; Notice of Filing

August 18, 2006.
    On August 10, 2006, BP Energy Company (BP Energy) and BP West Coast
Products LLC filed a supplemental informational filing relating to BP
Energy's June 17, 2002 triennial market-power update and June 17, 2005
triennial market power update filed by BP Energy on behalf of itself
and its affiliates in the above-captioned dockets.
    Any person desiring to intervene or to protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Rules of Practice and Procedure (18 CFR 385.211 and Sec.
385.214) on or before 5 p.m. Eastern time on the specified comment
date. It is not necessary to separately intervene again in a subdocket
related to a compliance filing if you have previously intervened in the
same docket. Protests will be considered by the Commission in
determining the appropriate action to be taken, but will not serve to
make protestants parties to the proceeding. Anyone filing a motion to
intervene or protest must serve a copy of that document on the
Applicant. In reference to filings initiating a new proceeding,
interventions or protests submitted on or before the comment deadline
need not be served on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov.
 To facilitate electronic service, persons with Internet

access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
14 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First St. NE., Washington, DC 20426.
    The filings in the above proceedings are accessible in the
Commission's eLibrary system by clicking on the appropriate link in the
above list. They are also available for review in the Commission's
Public Reference Room in Washington, DC. There is an eSubscription link
on the Web site that enables subscribers to receive e-mail notification
when a document is added to a subscribed dockets(s). For assistance
with any FERC Online service, please e-mail<EMAIL_ADDRESS>
or call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern Time on August 31, 2006.

Magalie R. Salas,
Secretary.
 [FR Doc. E6-14013 Filed 8-23-06; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 82, Number 82 (Monday, May 1, 2017)]
[Rules and Regulations]
[Pages 20257-20260]
[FR Doc No: 2017-08648]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R01-OAR-2017-0024; A-1-FRL-9961-42-Region 1]

Air Plan Approval; ME; Emission Statement Reporting

AGENCY: Environmental Protection Agency (EPA).

ACTION: Direct final rule.

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SUMMARY: The Environmental Protection Agency (EPA) is approving a State
Implementation Plan (SIP) revision submitted by the State of Maine. The
revision updates Maine's emissions reporting requirements for certain
stationary sources that emit criteria pollutants. The intended effect
of this action is to approve the revision into the Maine SIP. This
action is being taken under the Clean Air Act (CAA).

DATES: This direct final rule is effective June 30, 2017, unless EPA
receives adverse comments by May 31, 2017. 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-R01-
OAR-2017-0024 at http://www.regulations.gov, or via email to
<EMAIL_ADDRESS>For comments submitted at Regulations.gov,
follow the online instructions for submitting comments. Once submitted,
comments cannot be edited or removed from Regulations.gov. For either
manner of submission, the EPA may publish any comment received to its
public docket. Do not submit electronically any information you
consider to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute. Multimedia
submissions (audio, video, etc.) must be accompanied by a written
comment. The written comment is considered the

official comment and should include discussion of all points you wish
to make. The EPA will generally not consider comments or comment
contents located outside of the primary submission (i.e. on the web,
cloud, or other file sharing system). For additional submission
methods, please contact the person identified in the FOR FURTHER
INFORMATION CONTACT section. For the full EPA public comment policy,
information about CBI or multimedia submissions, and general guidance
on making effective comments, please visit http://www2.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: David L. Mackintosh, Air Quality
Planning Unit, U.S. Environmental Protection Agency, EPA New England
Regional Office, 5 Post Office Square--Suite 100, (Mail code OEP05-2),
Boston, MA 02109-3912, tel.<PHONE_NUMBER>, fax<PHONE_NUMBER>, email
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document whenever ``we,''
``us,'' or ``our'' is used, we mean EPA.
    The following outline is provided to aid in locating information in
this preamble.

I. What action is EPA taking?
II. What is the background for this action?
III. What is included in the submittal?
IV. EPA's Evaluation of the Submittal
V. Final Action
VI. Incorporation by Reference
VII. Statutory and Executive Order Reviews

I. What action is EPA taking?

    EPA is approving a SIP revision submitted by the State of Maine on
November 26, 2008, concerning updates to emission statement
requirements for certain stationary sources that emit criteria
pollutants. The Maine requirements, set out in Chapter 137 Emission
Statements, were revised to be consistent with EPA's Air Emissions
Reporting Requirements (AERR) at 40 CFR part 51, subpart A.

II. What is the background for this action?

    Sections 182(a)(3)(B) and 184(b)(2) of the CAA require that states
develop and submit, as SIP revisions, rules which establish annual
reporting requirements from certain stationary sources. EPA proposed
updates to AERR on January 3, 2006 (71 FR 69) and then finalized the
rule on December 17, 2008 (73 FR 76539). On November 26, 2008, Maine
submitted a formal revision to its State Implementation Plan (SIP),
which consists of updates to Maine's Chapter 137 Emission Statements
rule. On January 23, 2017, Maine withdrew from the submittal certain
sections of Chapter 137. EPA last approved Maine's Chapter 137 Emission
Statements on November 21, 2007 (72 FR 65462).

III. What is included in the submittal?

    Maine's November 26, 2008 SIP submittal includes Chapter 137
Emission Statements, effective in Maine on November 8, 2008, less the
portions Maine withdrew from the submittal on January 23, 2017. The
withdrawn sections no longer pending before EPA address non-criteria
pollutant (i.e., greenhouse gas and hazardous air pollutant (HAP))
reporting requirements. Specifically, the following sections of Chapter
137 were withdrawn from the submittal: Sections 1(C), (E), and (F);
Definitions 2(A) through (F) and (I); Sections 3(B) and (C); the last
sentence of Section 4(D)(5), and all of Appendices A and B.

IV. EPA's Evaluation of the Submittal

    Maine's Chapter 137 Emission Statements has been revised to
incorporate changes to be consistent with the AERR. The revised rule
adds a definition for the term ``Process Unit,'' which is defined as
``any combination of equipment or operation and material or fuel which
emits pollutants.'' The revised rule also includes an earlier emissions
statement filing deadline. The deadline which was previously September
1 of the year following the inventory, was changed to July 1, 2009 for
the 2008 inventory and then later changed to May 15 of the year
following the inventory year beginning with inventory year 2009. The
revisions also specify additional information to be submitted in the
inventory statements:
    1. Technical contact name, telephone number and email;
    2. Latitude and longitude method accuracy description code used to
define the accuracy of the geographic data;
    3. Emissions control status indicating whether reported emissions
are controlled or uncontrolled;
    4. Unit type code indicating the type of emissions unit (e.g.,
boiler, turbine, etc.);
    5. Unit operating status code indicating the operating status of
the emissions unit (e.g. operating, permanently shut down, etc.);
    6. Unit operating status date indicating the year in which the unit
status is applicable; and
    7. Emission release point type indicating the physical
configuration of the release point (e.g., stack, fugitive, etc.).

Maine's revised Chapter 137 includes additional reporting requirements
and requires information to be submitted earlier than the SIP-approved
version of the regulation and is consistent with the AERR. Thus, the
revised Chapter 137 Emission Statements satisfies the anti-back sliding
requirements in Section 110(l) of the CAA and we are approving Maine's
revised rule into the Maine SIP.

V. Final Action

    EPA is approving, and incorporating into the Maine SIP, revised
Chapter 137 Emission Statements, with the exception of portions of
Chapter 137 that were withdrawn from Maine's submittal: Sections 1(C),
(E), and (F); Definitions 2(A) through (F) and (I); Sections 3(B) and
(C); the last sentence of Section 4(D)(5); and Appendix A and B.
    The EPA is publishing this action without prior proposal because
the Agency views this as a noncontroversial amendment and anticipates
no adverse comments. However, in the proposed rules section of this
Federal Register publication, EPA is publishing a separate document
that will serve as the proposal to approve the SIP revision should
relevant adverse comments be filed. This rule will be effective June
30, 2017 without further notice unless the Agency receives relevant
adverse comments by May 31, 2017.
    If the EPA receives such comments, then EPA will publish a notice
withdrawing the final rule and informing the public that the rule will
not take effect. All public comments received will then be addressed in
a subsequent final rule based on the proposed rule. The EPA will not
institute a second comment period on the proposed rule. All parties
interested in commenting on the proposed rule should do so at this
time. If no such comments are received, the public is advised that this
rule will be effective on June 30, 2017 and no further action will be
taken on the proposed rule. Please note that if EPA receives adverse
comment on an amendment, paragraph, or section of this rule and if that
provision may be severed from the remainder of the rule, EPA may adopt
as final those provisions of the rule that are not the subject of an
adverse comment.

V. Incorporation by Reference

    In this rule, the EPA is finalizing regulatory text that includes
incorporation by reference. In accordance with requirements of 1 CFR
51.5, the EPA is finalizing the incorporation by reference of the State
of Maine regulation described in the amendments to 40 CFR part 52 set
forth below. The EPA has made, and will

continue to make, these materials generally available through
www.regulations.gov, and/or at the EPA Region 1 Office (please contact
the person identified in the FOR FURTHER INFORMATION CONTACT section of
this preamble for more information).

VI. Statutory and Executive Order Reviews

    Under the Clean Air Act, the Administrator is required to approve a
SIP submission that complies with the provisions of the Act 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 Clean Air Act.
Accordingly, this action merely approves state law as meeting Federal
requirements and does not impose additional requirements beyond those
imposed by state law. For that reason, this action:
     Is not a significant regulatory action subject to review
by the Office of Management and Budget under Executive Orders 12866 (58
FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the Clean Air Act; 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, the SIP is not approved to apply on any Indian reservation
land or in any other area where EPA or an Indian tribe has demonstrated
that a tribe has jurisdiction. In those areas of Indian country, the
rule does not have tribal implications and will not impose substantial
direct costs on tribal governments or preempt tribal law as specified
by Executive Order 13175 (65 FR 67249, November 9, 2000).
    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 Clean Air Act, petitions for
judicial review of this action must be filed in the United States Court
of Appeals for the appropriate circuit by June 30, 2017. Filing a
petition for reconsideration by the Administrator of this final rule
does not affect the finality of this action for the purposes of
judicial review nor does it extend the time within which a petition for
judicial review may be filed, and shall not postpone the effectiveness
of such rule or action. 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, Carbon monoxide,
Incorporation by reference, Intergovernmental relations, Lead, Nitrogen
dioxide, Ozone, Particulate matter, Reporting and recordkeeping
requirements, Sulfur oxides, Volatile organic compounds.

    Dated: March 16, 2017.
Deborah A. Szaro,
Acting Regional Administrator, EPA New England.

    Part 52 of chapter I, title 40 of the Code of Federal Regulations
is amended as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

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

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

Subpart U--Maine

0
2. In Sec.  52.1020(c), the table is amended by revising the entry for
``Chapter 137'' to read as follows:

Sec.  52.1020   Identification of plan.

* * * * *
    (c) * * *

                                                             EPA-Approved Maine Regulations
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                      State       EPA approval date  EPA approval date and
            State citation                   Title/subject       effective date                 citation \1\                        Explanations
--------------------------------------------------------------------------------------------------------------------------------------------------------

                                                                      * * * * * * *
Chapter 137..........................  Emission Statements.....      11/08/2008  05/01/2017 [Insert Federal Register        The entire chapter is
                                                                                citation].                                 approved with the exception
                                                                                of HAP and greenhouse gas
                                                                                reporting requirements
                                                                                which were withdrawn from
                                                                                the State's SIP revision:
                                                                                Sections 1(C), (E), and
                                                                                (F); Definitions 2(A)
                                                                                through (F) and (I);
                                                                                Sections 3(B) and (C); the
                                                                                last sentence of Section
                                                                                4(D)(5); and Appendix A and
                                                                                B.

                                                                      * * * * * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ In order to determine the EPA effective date for a specific provision listed in this table, consult the Federal Register notice cited in this column
  for the particular provision.

* * * * *
[FR Doc. 2017-08648 Filed 4-28-17; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: July 5, 2011 (Volume 76, Number 128)]
[Notices]
[Page 39086-39087]
[DOCID:fr05jy11-59]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings 1

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

    Docket Numbers: ER10-2310-001; ER10-2314-001; ER10-2311-001; ER10-
2312-001; ER10-2313-001; ER10-2315-001; ER10-2316-001; ER10-2318-001;
ER10-2321-001.
    Applicants: Covanta Maine, LLC, Covanta Essex Company, Covanta
Plymouth Renewable Energy Limited, Covanta Delaware Valley, L.P.,
Covanta Union, Inc., Covanta Hempstead Company, Covanta Niagara, L.P.,
Covanta Power, LLC, Covanta Energy Marketing LLC.
    Description: Updated Market Power Analysis of the Covanta MBR
Entities.
    Filed Date: 06/23/2011.
    Accession Number: 20110623-5112.
    Comment Date: 5 p.m. Eastern Time on Monday, August 22, 2011.

    Docket Numbers: ER10-2960-001.
    Applicants: Astoria Generating Company, L.P.
    Description: Astoria Generating Company, L.P. submits their updated
market power analysis in support of its continued market-based rate
authorization.
    Filed Date: 06/23/2011.
    Accession Number: 20110623-5163.
    Comment Date: 5 p.m. Eastern Time on Monday, August 22, 2011.

    Docket Numbers: ER10-3069-001; ER10-3070-001.
    Applicants: Alcoa Power Generating Inc., Alcoa Power Marketing LLC.
    Description: Updated Market Power Analysis of the Alcoa Companies.
    Filed Date: 06/23/2011.
    Accession Number: 20110623-5128.
    Comment Date: 5 p.m. Eastern Time on Monday, August 22, 2011.

    Docket Numbers: ER11-3409-001.
    Applicants: Florida Power & Light Company.
    Description: Florida Power & Light Company submits tariff filing
per 35: FPL Revisions to Attachments H-A and H-B Sections of the OATT
Compliance Filing to be effective 5/15/2011.
    Filed Date: 06/23/2011.
    Accession Number: 20110623-5092.
    Comment Date: 5 p.m. Eastern Time on Thursday, July 14, 2011.

    Docket Numbers: ER11-3847-001.
    Applicants: Public Service Company of New Mexico.
    Description: Public Service Company of New Mexico submits tariff
filing per 35.17(b): Re-submission of First Revised Service Agreement
317 to be effective 6/1/2011.
    Filed Date: 06/22/2011.
    Accession Number: 20110622-5003.
    Comment Date: 5 p.m. Eastern Time on Wednesday, July 13, 2011.

    Docket Numbers: ER11-3865-000.
    Applicants: PacifiCorp.
    Description: PacifiCorp submits tariff filing per 35.13(a)(2)(iii:
Owners Agmt for Operation of Pacific AC Intertie and CA-OR Transmission
Project to be effective 1/1/2012.
    Filed Date: 06/23/2011.
    Accession Number: 20110623-5080.
    Comment Date: 5 p.m. Eastern Time on Thursday, July 14, 2011.

    Docket Numbers: ER11-3866-000.
    Applicants: Lake Road Generating Company, L.P.
    Description: Lake Road Generating Company, L.P. submits tariff
filing per 35.37: Revisions to Market-Based Rate Tariff to be effective
6/24/2011.
    Filed Date: 06/23/2011.
    Accession Number: 20110623-5081.
    Comment Date: 5 p.m. Eastern Time on Thursday, July 14, 2011.

    Docket Numbers: ER11-3867-000.
    Applicants: MASSPOWER.
    Description: MASSPOWER submits tariff filing per 35.37: Revisions
to Market-Based Rate Tariff to be effective 6/24/2011.
    Filed Date: 06/23/2011.
    Accession Number: 20110623-5082.
    Comment Date: 5 p.m. Eastern Time on Thursday, July 14, 2011.

    Docket Numbers: ER11-3868-000.
    Applicants: Midwest Independent Transmission System Operator, Inc.
    Description: Midwest Independent Transmission System Operator, Inc.
submits tariff filing per 35.13(a)(2)(iii: NSP-WAPA Letter Agreement to
be effective 6/24/2011.
    Filed Date: 06/23/2011.
    Accession Number: 20110623-5088.
    Comment Date: 5 p.m. Eastern Time on Thursday, July 14, 2011.

    Docket Numbers: ER11-3869-000.
    Applicants: Southern California Edison Company.
    Description: Southern California Edison Company submits tariff
filing per 35.13(a)(2)(iii: LGIA Amendment CPV Sentinel Project to be
effective 6/22/2011.
    Filed Date: 06/23/2011.
    Accession Number: 20110623-5090.
    Comment Date: 5 p.m. Eastern Time on Thursday, July 14, 2011.

    Docket Numbers: ER11-3870-000.
    Applicants: Public Service Company of Colorado.
    Description: Public Service Company of Colorado submits tariff
filing per 35.13(a)(2)(iii: 2011-6-23--TSGT--FG--SS--COM--Agmt--318-
PSCo to be effective 5/24/2011.
    Filed Date: 06/23/2011.
    Accession Number: 20110623-5109.
    Comment Date: 5 p.m. Eastern Time on Thursday, July 14, 2011.

    Docket Numbers: ER11-3871-000.
    Applicants: PJM Interconnection, LLC.
    Description: PJM Interconnection, LLC. submits tariff filing per
35.13(a)(2)(iii: Queue No. W4-075; Original Service Agreement No. 2948
to be effective 5/26/2011.
    Filed Date: 06/23/2011.
    Accession Number: 20110623-5144.
    Comment Date: 5 p.m. Eastern Time on Thursday, July 14, 2011.

    Docket Numbers: ER11-3872-000.
    Applicants: Stony Creek Energy LLC.
    Description: Stony Creek Energy LLC submits tariff filing per
35.12: Application for Market-Based Rate Authorizations and Related
Waivers & Approvals to be effective 8/23/2011.
    Filed Date: 06/23/2011.
    Accession Number: 20110623-5145.
    Comment Date: 5 p.m. Eastern Time on Thursday, July 14, 2011.

    Docket Numbers: ER11-3873-000.
    Applicants: California Independent System Operator Corporation.
    Description: California Independent System Operator Corporation
submits tariff filing per 35.13(a)(2)(iii: 2011-06-23 CAISO CRR
Amendment to be effective 8/22/2011.
    Filed Date: 06/23/2011.
    Accession Number: 20110623-5147.
    Comment Date: 5 p.m. Eastern Time on Thursday, July 14, 2011.

    Docket Numbers: ER11-3874-000.
    Applicants: PJM Interconnection, LLC.
    Description: PJM Interconnection, LLC submits tariff filing per
35.13(a)(2)(iii: Queue No. W2-059; Original Service Agreement No. 2937
to be effective 5/25/2011.
    Filed Date: 06/23/2011.
    Accession Number: 20110623-5148.
    Comment Date: 5 p.m. Eastern Time on Thursday, July 14, 2011.

    Docket Numbers: ER11-3875-000.
    Applicants: Southern California Edison Company.
    Description: Southern California Edison Company cancels Letter
Agreement with Abengoa Solar.
    Filed Date: 06/24/2011.
    Accession Number: 20110624-5012.
    Comment Date: 5 p.m. Eastern Time on Friday, July 15, 2011.

    Take notice that the Commission received the following public
utility holding company filings:

    Docket Numbers: PH11-15-000.
    Applicants: SteelRiver Infrastructure Partners LP.
    Description: Form 65-A of SteelRiver Infrastructure Partners LP.
    Filed Date: 06/23/2011.
    Accession Number: 20110623-5168.
    Comment Date: 5 p.m. Eastern Time on Thursday, July 14, 2011.

    Any person desiring to intervene or to protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Rules of Practice and Procedure (18 CFR 385.211 and
385.214) on or before 5 p.m. Eastern time on the specified comment
date. It is not necessary to separately intervene again in a subdocket
related to a compliance filing if you have previously intervened in the
same docket. Protests will be considered by the Commission in
determining the appropriate action to be taken, but will not serve to
make protestants parties to the proceeding. Anyone filing a motion to
intervene or protest must serve a copy of that document on the
Applicant. In reference to filings initiating a new proceeding,
interventions or protests submitted on or before the comment deadline
need not be served on persons other than the Applicant.
    As it relates to any qualifying facility filings, the notices of
self-certification [or self-recertification] listed above, do not
institute a proceeding regarding qualifying facility status. A notice
of self-certification [or self-recertification] simply provides
notification that the entity making the filing has determined the
facility named in the notice meets the applicable criteria to be a
qualifying facility. Intervention and/or protest do not lie in dockets
that are qualifying facility self-certifications or self-
recertifications. Any person seeking to challenge such qualifying
facility status may do so by filing a motion pursuant to 18 CFR
292.207(d)(iii). Intervention and protests may be filed in response to
notices of qualifying facility dockets other than self-certifications
and self-recertifications.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://
www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
14 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First St., NE., Washington, DC 20426.
    The filings in the above proceedings are accessible in the
Commission's eLibrary system by clicking on the appropriate link in the
above list. They are also available for review in the Commission's
Public Reference Room in Washington, DC. There is an eSubscription link
on the Web site that enables subscribers to receive e-mail notification
when a document is added to a subscribed dockets(s). For assistance
with any FERC Online service, please e-mail<EMAIL_ADDRESS>
or call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.

    Dated: June 24, 2011.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2011-16695 Filed 7-1-11; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 78, Number 45 (Thursday, March 7, 2013)]
[Notices]
[Pages 14781-14782]
[FR Doc No: 2013-05270]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings 2

    Take notice that the Commission received the following electric
rate filings:
    Docket Numbers: ER11-4050-001; ER11-4027-002; ER11-4028-002.
    Applicants: Cogentrix of Alamosa, LLC, Portsmouth Genco, LLC, James
River Genco, LLC.
    Description: Second Supplement to January 14, 2013 Notice of Non-
Material Change in Status of Cogentrix of Alamosa, LLC, et al.
    Filed Date: 2/27/13.
    Accession Number: 20130227-5029.
    Comments Due: 5 p.m. ET 3/14/13.

    Docket Numbers: ER12-2068-002.
    Applicants: Blue Sky East, LLC.
    Description: Notice of Change in Status of Blue Sky East, LLC.
    Filed Date: 2/28/13.
    Accession Number: 20130228-5296.
    Comments Due: 5 p.m. ET 3/21/13.

    Docket Numbers: ER13-486-001.
    Applicants: PJM Interconnection, L.L.C.
    Description: PJM Interconnection, L.L.C. submits Response to the
Commission's 1/29/2013 Letter Requesting Additional Information to be
effective 1/31/2013.
    Filed Date: 2/28/13.
    Accession Number: 20130228-5324.
    Comments Due: 5 p.m. ET 3/21/13.

    Docket Numbers: ER13-681-001.
    Applicants: The Empire District Electric Company.
    Description: The Empire District Electric Company submits
Supplement to Filing to be effective 1/1/2013.
    Filed Date: 2/28/13.
    Accession Number: 20130228-5340.
    Comments Due: 5 p.m. ET 3/21/13.

    Docket Numbers: ER13-698-001.
    Applicants: Southard Energy Partners LLC.
    Description: Southard Energy Partners, LLC FERC Electric Tariff to
be effective 2/11/2013.
    Filed Date: 2/28/13.
    Accession Number: 20130228-5232.
    Comments Due: 5 p.m. ET 3/21/13.

    Docket Numbers: ER13-708-001.
    Applicants: Midwest Independent Transmission System Operator, Inc.
    Description: 02-28-13 Appendix K 205 Rights Amendment to be
effective 12/18/2013.
    Filed Date: 2/28/13.
    Accession Number: 20130228-5255.
    Comments Due: 5 p.m. ET 3/21/13.

    Docket Numbers: ER13-773-001.
    Applicants: CCI Roseton LLC.
    Description: CCI Roseton LLC submits Supplement MBR Filing to be
effective 1/18/2013.
    Filed Date: 2/28/13.
    Accession Number: 20130228-5318.
    Comments Due: 5 p.m. ET 3/14/13.

    Docket Numbers: ER13-1002-000.
    Applicants: Public Service Company of New Mexico.
    Description: Transmission Construction and Interconnection
Agreement with Jicarilla Nation to be effective 4/26/2013.
    Filed Date: 2/28/13.
    Accession Number: 20130228-5057.
    Comments Due: 5 p.m. ET 3/21/13.

    Docket Numbers: ER13-1003-000.
    Applicants: Pacific Gas and Electric Company.
    Description: Pacific Gas and Electric Company submits Notices of
Termination of Service Agreement Nos. 28 and 29.
    Filed Date: 2/28/13.
    Accession Number: 20130228-5085.
    Comments Due: 5 p.m. ET 3/21/13.

    Docket Numbers: ER13-1004-000.
    Applicants: Midwest Independent Transmission System Operator, Inc.
    Description: 2013-02-28 Schedule 27 DAMAP to be effective 3/1/2013.
    Filed Date: 2/28/13.
    Accession Number: 20130228-5090.
    Comments Due: 5 p.m. ET 3/8/13.

    Docket Numbers: ER13-1005-000.
    Applicants: PacifiCorp.
    Description: DGT, UAMPS, UMPA Revised TSOAs to be effective 5/1/
2013.
    Filed Date: 2/28/13.
    Accession Number: 20130228-5231.
    Comments Due: 5 p.m. ET 3/21/13.

    Docket Numbers: ER13-1006-000.
    Applicants: Public Service Company of Colorado.
    Description: Public Service Company of Colorado submits Notice of
Power Purchase Agreement with Colorado Springs Utilities.
    Filed Date: 2/28/13.
    Accession Number: 20130228-5291.
    Comments Due: 5 p.m. ET 3/21/13.
    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 5:00
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: February 28, 2013.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2013-05270 Filed 3-6-13; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 84, Number 126 (Monday, July 1, 2019)]
[Notices]
[Page 31314]
[FR Doc No: 2019-13951]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:

Filings Instituting Proceedings

    Docket Numbers: RP19-1324-000.
    Applicants: Texas Eastern Transmission, LP.
    Description: Sec.  4(d) Rate Filing: Jun2019 Conversion of FTS
Agreements to FT-1 Agreements to be effective 7/20/2019.
    Filed Date: 6/20/19.
    Accession Number: 20190620-5053.
    Comments Due: 5 p.m. ET 7/2/19.

    Docket Numbers: RP19-1325-000.
    Applicants: Iroquois Gas Transmission System, L.P.
    Description: Sec.  4(d) Rate Filing: 062019 Negotiated Rates--
ConocoPhillips Company R-3015-05 to be effective 7/1/2019.
    Filed Date: 6/20/19.
    Accession Number: 20190620-5076.
    Comments Due: 5 p.m. ET 7/2/19.

    Docket Numbers: RP19-1326-000.
    Applicants: Dominion Energy Transmission, Inc.
    Description: Sec.  4(d) Rate Filing: DETI--June 20, 2019 Negotiated
Rate Agreement to be effective 7/1/2019.
    Filed Date: 6/20/19.
    Accession Number: 20190620-5096.
    Comments Due: 5 p.m. ET 7/2/19.

    Docket Numbers: RP19-1327-000.
    Applicants: Colorado Interstate Gas Company, L.L.C.
    Description: Sec.  4(d) Rate Filing: Non-Conforming Negotiated Rate
Agmt Filing (Rocky Mtn Midstrm 214627-TFHPCIG) to be effective 7/20/
2019.
    Filed Date: 6/20/19.
    Accession Number: 20190620-5116.
    Comments Due: 5 p.m. ET 7/2/19.

    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 5:00
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: June 25, 2019.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2019-13951 Filed 6-28-19; 8:45 am]
BILLING CODE 6717-01-P