[Federal Register: March 1, 2010 (Volume 75, Number 39)]
[Notices]
[Page 9227-9228]
[DOCID:fr01mr10-91]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-E-0206]

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

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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SUMMARY:  The Food and Drug Administration (FDA) has determined the
regulatory review period for FIRMAGON and is publishing this notice of
that determination as required by law. FDA has made the determination
because of the submission of an application to the Director of Patents
and Trademarks, Department of Commerce, for the extension of a patent
which claims that human drug product.

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

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

SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term
Restoration Act of 1984 (Public Law 98-417) and the Generic Animal Drug
and Patent Term Restoration Act (Public Law 100-670) generally provide
that a patent may be extended for a period of up to 5 years so long as
the patented item (human drug product, animal drug product, medical
device, food additive, or color additive) was subject to regulatory
review by FDA before the item was marketed. Under these acts, a
product's regulatory review period forms the basis for determining the
amount of extension an applicant may receive.
    A regulatory review period consists of two periods of time: A
testing phase and an approval phase. For human drug products, the
testing phase begins when the exemption to permit the clinical
investigations of the drug becomes effective and runs until the
approval phase begins. The approval phase starts with the initial
submission of an application to market the human drug product and
continues until FDA grants permission to market the drug product.
Although only a portion of a regulatory review period may count toward
the actual amount of extension that the Director of Patents and
Trademarks may award (for example, half the testing phase must be
subtracted as well as any time that may have occurred before the patent
was issued), FDA's determination of the length of a regulatory review
period for a human drug product will include all of the testing phase
and approval phase as specified in 35 U.S.C. 156(g)(1)(B).
    FDA recently approved for marketing the human drug product FIRMAGON
(degarelix acetate). FIRMAGON is indicated for treatment of patients
with advanced prostate cancer. Subsequent to this approval, the Patent
and Trademark Office received a patent term restoration application for
FIRMAGON (U.S. Patent No. 5,925,730) from Ferring BV, and the Patent
and Trademark Office requested FDA's assistance in determining this
patent's eligibility for patent term restoration. In a letter dated
September 29, 2009, FDA advised the Patent and Trademark Office that
this human drug product had undergone a regulatory review period and
that the approval of FIRMAGON represented the first permitted
commercial marketing or use of the product. Thereafter, the Patent and
Trademark Office requested that FDA determine the product's regulatory
review period.
    FDA has determined that the applicable regulatory review period for
FIRMAGON is 2,695 days. Of this time, 2,394 days occurred during the
testing phase of the regulatory review period, while 301 days occurred
during the approval phase. These periods of time were derived from the
following dates:
    1. The date an exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (the act) (21 U.S.C. 355(i)) became effective:
August 10, 2001. FDA has verified the applicant's claim that the date
the investigational new drug application became effective was on August
10, 2001.
    2. The date the application was initially submitted with respect to
the human drug product under section 505(b) of the act: February 28,
2008. FDA has verified the applicant's claim that the new drug
application (NDA) 22-201 was submitted on February 28, 2008.
    3. The date the application was approved: December 24, 2008. FDA
has verified the applicant's claim that NDA 22-201 was approved on
December 24, 2008.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the U.S.
Patent and Trademark Office applies several statutory limitations in
its calculations of the actual period for patent extension. In its
application for patent extension, this applicant seeks 1,498 days of
patent term extension.
    Anyone with knowledge that any of the dates as published are
incorrect may submit to the Division of Dockets Management (see
ADDRESSES) written or electronic comments and ask for a redetermination
by April 30, 2010. Furthermore, any interested person may petition FDA
for a determination regarding whether the applicant for extension acted
with due diligence during the regulatory review period by August 30,
2010. To meet its burden, the petition must contain sufficient facts to
merit an FDA investigation. (See H. Rept. 857, part 1, 98th Cong., 2d
sess., pp. 41-42, 1984.) Petitions should be in the format specified in
21 CFR 10.30.
    Comments and petitions should be submitted to the Division of
Dockets Management. Three copies of any mailed information are to be
submitted, except that individuals may submit one copy. Comments are to
be identified with the docket number found in brackets in the heading
of this document.
    Comments and petitions may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: February 9, 2010.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. 2010-4159 Filed 2-26-10; 8:45 am]
BILLING CODE 4160-01-S


[Federal Register Volume 86, Number 186 (Wednesday, September 29, 2021)]
[Notices]
[Page 53957]
[FR Doc No: 2021-21155]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 1061-103]

Pacific Gas and Electric Company; Notice of Intent To Prepare an
Environmental Assessment

    On August 24, 2020, Pacific Gas and Electric Company filed an
application for a major, new license for the 1.6 megawatts Phoenix
Hydroelectric Project (FERC No. 1061). The existing project is located
on the South Fork Stanislaus River and in the Tuolumne River Basin, in
Tuolumne County, California. The project occupies 26.99 acres of
federal land administered by the U.S. Forest Service and 0.59 acres
administered by the Bureau of Land Management.
    In accordance with the Commission's regulations, on July 2, 2021,
Commission staff issued a notice that the project was ready for
environmental analysis (REA Notice). Based on the information in the
record, including comments filed on the REA Notice, staff does not
anticipate that licensing the project would constitute a major federal
action significantly affecting the quality of the human environment.
Therefore, staff intends to prepare a draft and final Environmental
Assessment (EA) on the application to relicense the Phoenix Project.
    The EA will be issued and circulated for review by all interested
parties. All comments filed on the EA will be analyzed by staff and
considered in the Commission's final licensing decision.
    The application will be processed according to the following
schedule. Revisions to the schedule may be made as appropriate.
---------------------------------------------------------------------------

    \1\ The Council on Environmental Quality's (CEQ) regulations
under 40 CFR 1501.10(b)(1) require that EAs be completed within 1
year of the federal action agency's decision to prepare an EA. This
notice establishes the Commission's intent to prepare a draft and
final EA for the Phoenix Project. Therefore, in accordance with
CEQ's regulations, the final EA must be issued within 1 year of the
issuance date of this notice.

------------------------------------------------------------------------
                 Milestone                           Target date
------------------------------------------------------------------------
Commission issues draft EA................  May 2022.
Comments on draft EA......................  June 2022.
Commission issues final EA................  September 2022 \1\.
------------------------------------------------------------------------

    Any questions regarding this notice may be directed to Jim
Hastreiter at<PHONE_NUMBER> or<EMAIL_ADDRESS>
    Dated: September 23, 2021.
Kimberly D. Bose,
Secretary.
[FR Doc. 2021-21155 Filed 9-28-21; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: January 27, 2006 (Volume 71, Number 18)]
[Notices]
[Page 4575-4576]
[DOCID:fr27ja06-45]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 620]

NorQuest Seafood Inc.; Notice of Authorization for Continued
Project Operation

January 20, 2006.
    On October 3, 2003, NorQuest Seafood, Inc., licensee for the
Chignik Hydroelectric Project No. 620, filed an application for a new
or subsequent license pursuant to the Federal Power Act (FPA) and the
Commission's regulations there under. Project No. 620 is located on
Indian Creek in Chignik, Alaska.
    The license for Project No. 620 was issued for a period ending
October 31, 2005. 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. 620 is issued to
NorQuest Seafood Inc., for a period effective November 1, 2005 through
October 31, 2006, 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 October 1, 2006, 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 NorQuest Seafood Inc. is authorized to continue
operation of the Chignik Hydroelectric Project No. 620 until such time
as the Commission acts on its application for subsequent license.

Magalie R. Salas,
Secretary.
 [FR Doc. E6-999 Filed 1-26-06; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 88, Number 85 (Wednesday, May 3, 2023)]
[Proposed Rules]
[Pages 27839-27845]
[FR Doc No: 2023-09415]

=======================================================================
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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 147

[Docket Number USCG-2023-0277]
RIN 1625-AA00

Safety Zone; Vineyard Wind 1 Wind Farm Project Area, Outer
Continental Shelf, Lease OCS-A 0501, Offshore Massachusetts, Atlantic
Ocean

AGENCY: Coast Guard, DHS.

ACTION: Notice of proposed rulemaking.

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SUMMARY: The Coast Guard is proposing to establish 63 temporary 500-
meter safety zones around the construction of 62 wind turbine
generators (WTGs) and one electrical service platform (ESP) located in
the Vineyard Wind 1 Wind Farm (VW1WF) project area within federal
waters on the Outer Continental Shelf (OCS), specifically in the
northern portion of Bureau of Ocean Energy Management (BOEM) Renewable
Energy Lease Area OCS-A 0501, approximately 12 nautical miles (NM)
offshore of Martha's Vineyard, Massachusetts and 12 NM offshore
Nantucket, Massachusetts. This action is necessary to provide for the
safety of life, property, and the environment during the planned
construction of each facility's monopile type foundation and subsequent
installation of the WTGs turbines and ESP platform from June 15, 2023,
to May 31, 2024. When enforced, only attending vessels and those
vessels specifically authorized by the First Coast Guard District
Commander, or a designated representative, are permitted to enter or
remain in the temporary safety zones. We invite your comments on this
proposed rulemaking.

DATES: Comments and related material must be received by the Coast
Guard on or before June 2, 2023.

ADDRESSES: You may submit comments identified by docket number USCG-
2023-0277 using the Federal Decision-Making Portal at https://www.regulations.gov. See the ``Public Participation and Request for
Comments'' portion of the SUPPLEMENTARY INFORMATION section for further
instructions on submitting comments.

FOR FURTHER INFORMATION CONTACT: If you have questions about this
proposed rulemaking, call or email Mr. Craig Lapiejko, Waterways
Management, at Coast Guard First District, telephone<PHONE_NUMBER>,
email [email protected].

SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

BOEM Bureau of Ocean Energy Management
CFR Code of Federal Regulations
DD Degrees Decimal
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of Proposed Rulemaking
OCS Outer Continental Shelf
OSS Offshore Substation
NAD 83 North American Datum of 1983
NM Nautical Mile
Sec.  Section
U.S.C. United States Code
WTG Wind Turbine Generator
VW1WF Vineyard Wind 1 Wind Farm

II. Background, Purpose, and Legal Basis

    On March 15, 2023, Vineyard Wind, LLC, an offshore wind farm
developer, notified the Coast Guard that they plan to begin
construction of facilities in the VW1WF project area within federal
waters on the OCS, specifically in the northern portion of BOEM
Renewable Energy Lease Area OCS-A 0501, approximately 12 NM offshore
Martha's Vineyard, Massachusetts and 12 NM offshore Nantucket,
Massachusetts in June 2023.
    The extremely complex offshore construction of these OCS facilities
presents many unusually hazardous conditions including hydraulic pile
driving hammer operations, heavy lift operations, overhead cutting
operations, potential falling debris, increased vessel traffic, and
stationary barges in close proximity to the facilities and each other.
    Based on these circumstances, the First Coast Guard District
Commander has determined that establishment of 63 temporary safety
zones through rulemaking is warranted to ensure the safety of life,
property, and the environment within a 500-meter radius of each of the
63 facilities during their construction.
    The Coast Guard is proposing this rule under the authorities
provided in 14 U.S.C. 544, 43 U.S.C. 1333, and Department of Homeland
Security (DHS) Delegation No. 00170.1, Revision No. 01.3. As an
implementing regulation of this authority, 33 CFR part 147 permits the
establishment of safety zones for non-mineral energy resource permanent
or temporary structures located on the OCS for the purpose of
protecting life and property on the facilities, appurtenances and
attending vessels, and on the adjacent waters within the safety zone
(see 33 CFR 147.10). Accordingly, a safety zone established under 33
CFR part 147 may also include provisions to restrict, prevent, or
control certain activities, including access by vessels or persons to
maintain safety of life, property, and the environment. If, as we
anticipate, we issue a temporary final rule and make it effective less
than 30 days after publication in the Federal Register, we will explain
in that publication, as required by 5 U.S.C. (d)(3), our good cause for
doing so.

III. Discussion of Proposed Rule

    The District Commander is proposing to establish 63 temporary 500-
meter safety zones around the construction of 62 WTGs and one ESP on
the OCS from June 15, 2023, through 11:59 p.m. on May 31, 2024.
    The construction of these facilities is expected to take place in
mixed phases alternating between the installation of several monopile
type foundations followed by the installation of the upper structures
then repeating this process throughout the project area until all 63
facilities have been completed. The 63 temporary safety zones would be
enforced individually as construction progresses from one structure
location to the next throughout the entire process for a period lasting
approximately 48 hours. The Coast Guard would make

notice of each enforcement period via the Local Notice to Mariners and
issue a Broadcast Notice to Mariners via marine channel 16 (VHF-FM) as
soon as practicable in response to an emergency or hazardous condition.
The Coast Guard is publishing this rulemaking to be effective, and
enforceable, through May 31, 2024, to encompass any construction delays
due to weather or other unforeseen circumstances. If the project is
completed before May 31, 2024, enforcement of the safety zones would be
suspended, and notice given via Local Notice to Mariners.
    Additional information about the construction process of the VW1WF
can be found at https://www.boem.gov/vineyard-wind.
    The 63 temporary 500-meter safety zones around the construction of
62 WTGs and one ESP are in the VW1WF project area, specifically in the
northern portion of BOEM Renewable Energy Lease Area OCS-A 0501,
approximately 12 NM offshore of Martha's Vineyard, Massachusetts and 12
NM offshore Nantucket, Massachusetts, within federal waters on the OCS.
    The positions of each individual safety zone proposed by this
rulemaking will be referred to using a unique alpha-numeric naming
convention outlined in the ``Rhode Island and Massachusetts Structure
Labeling Plot (West).'' \1\
---------------------------------------------------------------------------

    \1\ The Rhode Island and Massachusetts Structure Labeling Plot
(West) is an attachment to the Conditions of Construction and
Operations Plan Approval Lease Number OCS-A 0517 (boem.gov) and can
be found at https://www.boem.gov/sites/default/files/documents/renewable-energy/state-activities/SFWF-COP-Terms-and-Conditions.pdf.
---------------------------------------------------------------------------

    Aligning with authorities under 33 CFR 147.15, the proposed safety
zones would include the area within 500-meters of the center point of
the positions provided in the following table expressed in Decimal
Degrees (DD) based on North American Datum 1983 (NAD 83).

----------------------------------------------------------------------------------------------------------------
                     Name                                 Facility type              Latitude        Longitude
----------------------------------------------------------------------------------------------------------------
AL38..........................................  WTG.............................      41.1370161     -70.4638911
AM37..........................................  ESP.............................      41.1200616     -70.4851682
AM38..........................................  WTG.............................      41.1203387     -70.4635204
AM39..........................................  WTG.............................      41.1206168     -70.4414663
AN36..........................................  WTG.............................      41.1030927     -70.5072461
AN37..........................................  WTG.............................      41.1033791     -70.4851982
AN38..........................................  WTG.............................      41.1036612     -70.4631500
AN39..........................................  WTG.............................      41.1039392     -70.4411014
AP35..........................................  WTG.............................      41.0861251     -70.5289069
AP36..........................................  WTG.............................      41.0864155     -70.5068649
AP37..........................................  WTG.............................      41.0867017     -70.4848226
AP38..........................................  WTG.............................      41.0869837     -70.4627799
AP39..........................................  WTG.............................      41.0872615     -70.4407369
AP40..........................................  WTG.............................      41.0875351     -70.4186937
AP41..........................................  WTG.............................      41.0878044     -70.3966501
AQ34..........................................  WTG.............................      41.0691535     -70.5505566
AQ35..........................................  WTG.............................      41.0694480     -70.5285205
AQ36..........................................  WTG.............................      41.0697382     -70.5064840
AQ37..........................................  WTG.............................      41.0700243     -70.4844472
AQ38..........................................  WTG.............................      41.0703061     -70.4624101
AQ39..........................................  WTG.............................      41.0705837     -70.4403727
AQ40..........................................  WTG.............................      41.0708571     -70.4183350
AQ41..........................................  WTG.............................      41.0711263     -70.3962970
AQ42..........................................  WTG.............................      41.0713913     -70.3742587
AR33..........................................  WTG.............................      41.0521781     -70.5721951
AR34..........................................  WTG.............................      41.0524766     -70.5501649
AR35..........................................  WTG.............................      41.0527709     -70.5281343
AR36..........................................  WTG.............................      41.0530609     -70.5061034
AR37..........................................  WTG.............................      41.0533468     -70.4840722
AR38..........................................  WTG.............................      41.0536285     -70.4620407
AR39..........................................  WTG.............................      41.0539059     -70.4400088
AR40..........................................  WTG.............................      41.0541792     -70.4179767
AR41..........................................  WTG.............................      41.0544482     -70.3959442
AR42..........................................  WTG.............................      41.0547130     -70.3739115
AS32..........................................  WTG.............................      41.0351987     -70.5938225
AS33..........................................  WTG.............................      41.0355012     -70.5717982
AS34..........................................  WTG.............................      41.0357995     -70.5497735
AS35..........................................  WTG.............................      41.0360937     -70.5277485
AS36..........................................  WTG.............................      41.0363836     -70.5057231
AS37..........................................  WTG.............................      41.0366693     -70.4836975
AS38..........................................  WTG.............................      41.0369508     -70.4616715
AS39..........................................  WTG.............................      41.0372281     -70.4396452
AS40..........................................  WTG.............................      41.0375012     -70.4176186
AS41..........................................  WTG.............................      41.0377701     -70.3955918
AS42..........................................  WTG.............................      41.0380347     -70.3735646
AT33..........................................  WTG.............................      41.0188243     -70.5714016
AT34..........................................  WTG.............................      41.0191225     -70.5493824
AT35..........................................  WTG.............................      41.0194164     -70.5273630
AT36..........................................  WTG.............................      41.0197062     -70.5053432
AT37..........................................  WTG.............................      41.0199917     -70.4833231
AT38..........................................  WTG.............................      41.0202731     -70.4613027
AT39..........................................  WTG.............................      41.0205502     -70.4392819
AT40..........................................  WTG.............................      41.0208231     -70.4172609

AT41..........................................  WTG.............................      41.0210918     -70.3952396
AU36..........................................  WTG.............................      41.0030287     -70.5049636
AU37..........................................  WTG.............................      41.0033141     -70.4829490
AU38..........................................  WTG.............................      41.0035953     -70.4609341
AU39..........................................  WTG.............................      41.0038722     -70.4389190
AU40..........................................  WTG.............................      41.0041450     -70.4169035
AV37..........................................  WTG.............................      40.9866364     -70.4825752
AV38..........................................  WTG.............................      40.9869174     -70.4605659
AV39..........................................  WTG.............................      40.9871942     -70.4385563
AW38..........................................  WTG.............................      40.9702395     -70.4601980
----------------------------------------------------------------------------------------------------------------

    The positions of the 63 proposed safety zones are shown on the
following chartlets. For scaling purposes, there is approximately one
NM spacing between each position.
BILLING CODE 9110-04-P
[GRAPHIC] [TIFF OMITTED] TP03MY23.017

[GRAPHIC] [TIFF OMITTED] TP03MY23.018

[GRAPHIC] [TIFF OMITTED] TP03MY23.019

BILLING CODE 9110-04-C
    Navigation in the vicinity of the proposed safety zones consists of
large commercial shipping vessels, fishing vessels, cruise ships, tugs
with tows, and recreational vessels.
    When enforced, no unauthorized vessel or person would be permitted
to enter the safety zone without obtaining permission from the First
Coast Guard District Commander or a designated representative. Requests
for entry into the safety zone would be considered and reviewed on a
case-by-case basis. Persons or vessels seeking to enter the safety zone
must request authorization from the First Coast Guard District
Commander or designated representative via VHF-FM channel 16 or by
phone at<PHONE_NUMBER> (First Coast Guard District Command Center). If
permission is granted, all persons and vessels shall comply with the
instructions of the First Coast Guard District Commander or designated
representative.
    The proposed regulatory text appears at the end of this document.

IV. Regulatory Analyses

    We developed this proposed rule after considering numerous statutes
and Executive Orders related to rulemaking. A summary of our analyses
based on these statutes and Executive Orders follows.

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. This NPRM has not been designated a ``significant
regulatory action,'' under Executive Order 12866. Accordingly, the NPRM
has not been reviewed by the Office of Management and Budget (OMB).
    Aligning with 33 CFR 147.15, the safety zones established would
extend to a maximum distance of 500-meters around the OCS facility
measured from its center point. Vessel traffic would be able to safely
transit around the proposed safety zones, which would impact a small,
designated area in the Atlantic Ocean, without significant impediment
to their voyage. This safety zone would provide for the safety of life,
property, and the environment during the construction of each
structure, in accordance with Coast Guard maritime safety missions.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as
amended, requires Federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this
proposed rule would not have a significant economic impact on a
substantial number of small entities.
    This rule may affect owners or operators of vessels intending to
transit or anchor in the VW1WF, some of which might be small entities.
However, these safety zones would not have a significant economic
impact on a substantial number of these entities because they are
temporarily enforced, allow for deviation requests, and do not impact
vessel transit significantly. Regarding the enforcement period,
although these safety zones would be in effect from June 15, 2023,
through May 31, 2024, vessels would only be prohibited from the
regulated zone during periods of actual construction activity in
correspondence to the period of enforcement. We expect the enforcement
period at each location to last approximately 48 hours as construction
progresses from one structure location to the next throughout the mixed
phases. Additionally, vessel traffic could pass safely around each
safety zone using an alternate route. Use of an alternate route likely
will cause minimal delay for the vessel in reaching their destination
depending on other traffic in the area and vessel speed. Vessels would
also be able to request deviation from this rule to transit through a
safety zone. Such requests would be considered on a case by-case basis
and may be authorized by the First Coast Guard District Commander or a
designated representative. For these reasons, the Coast Guard expects
any impact of this rulemaking establishing a temporary safety zone
around these OCS facilities to be minimal and have no significant
economic impact on small entities.
    If you think that your business, organization, or governmental
jurisdiction qualifies as a small entity and that this proposed rule
would have a significant economic impact on it, please submit a comment
(see ADDRESSES) explaining why you think it qualifies and how and to
what degree this rule would economically affect it.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this proposed rule. If the proposed rule
would affect your small business, organization, or governmental
jurisdiction and you have questions concerning its provisions or
options for compliance, please call or email the person listed in the
FOR FURTHER INFORMATION CONTACT section. The Coast Guard will not
retaliate against small entities that question or complain about this
proposed rule or any policy or action of the Coast Guard.

C. Collection of Information

    This proposed rule would not call for a new collection of
information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520).

D. Federalism and Indian Tribal Governments

    A rule has implications for federalism under Executive Order 13132
(Federalism), if it has a substantial direct effect on the States, on
the relationship between the National Government and the States, or on
the distribution of power and responsibilities among the various levels
of government. We have analyzed this proposed rule under that Order and
have determined that it is consistent with the fundamental federalism
principles and preemption requirements described in Executive Order
13132.
    Also, this proposed rule does not have tribal implications under
Executive Order 13175 (Consultation and Coordination with Indian Tribal
Governments) because it would not have a substantial direct effect on
one or more Indian tribes, on the relationship between the Federal
Government and Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes. If
you believe this proposed rule has implications for federalism or
Indian tribes, please call or email the person listed in the FOR
FURTHER INFORMATION CONTACT section.

E. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this proposed rule would not
result in such an expenditure, we do discuss the potential effects of
this proposed rule elsewhere in this preamble.

F. Environment

    We have analyzed this proposed rule under Department of Homeland
Security Directive 023-01, Rev. 1, associated implementing
instructions, and Environmental Planning COMDTINST 5090.1 (series),
which guide the Coast Guard in complying with the National
Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have made
a preliminary determination that this action is one of a category of
actions that do not individually or cumulatively have a significant
effect on the human environment. This proposed rule involves the
establishment of a safety zone around an OCS facility to protect life,
property, and the marine environment. Normally such actions are
categorically excluded from further review under paragraph L60 of
Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 1. A
preliminary Record of Environmental Consideration supporting this
determination is available in the docket. For instructions on locating
the docket, see the ADDRESSES section of this preamble. We seek any
comments or information that may lead to the discovery of a significant
environmental impact from this proposed rule.

G. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to call or email the person listed in the FOR
FURTHER INFORMATION CONTACT section to coordinate protest activities so
that your message can be received without jeopardizing the safety or
security of people, places, or vessels.

V. Public Participation and Request for Comments

    We view public participation as essential to effective rulemaking
and will consider all comments and material received during the comment
period. Your comment can help shape the outcome of this rulemaking. If
you submit a comment, please include the docket number for this
rulemaking, indicate the specific section of this document to which
each comment applies, and provide a reason for each suggestion or
recommendation.
    Submitting comments. We encourage you to submit comments through
the Federal Decision-Making Portal at https://www.regulations.gov. To
do so, go to https://www.regulations.gov, type USCG-2023-0277 in the
search box and click ``Search.'' Next, look for this document in the
Search Results column, and click on it. Then click on the Comment
option. If you cannot submit your material by using https://www.regulations.gov, call or email the person in the FOR FURTHER
INFORMATION CONTACT section of this proposed rule for alternate
instructions.
    Viewing material in docket. To view documents mentioned in this
proposed rule as being available in the docket, find the docket as
described in the previous paragraph, and then select ``Supporting &
Related Material'' in the Document Type column. Public comments will
also be placed in our online docket and can be viewed by following
instructions on the https://www.regulations.gov Frequently Asked
Questions web page. We review all comments received, but we will only
post comments that address the topic of the proposed rule. We may
choose not to post off-topic, inappropriate, or duplicate comments that
we receive.
    Personal information. We accept anonymous comments. Comments we
post to https://www.regulations.gov will include any personal
information you have provided. For more about privacy and submissions
to the docket in response to this document, see DHS's eRulemaking
System of Records notice (85 FR 14226, March 11, 2020).

List of Subjects in 33 CFR Part 147

    Continental shelf, Marine safety, Navigation (waters).

    For the reasons discussed in the preamble, the Coast Guard is
proposing to amend 33 CFR part 147 as follows:

PART 147--SAFETY ZONES

0
1. The authority citation for part 147 continues to read as follows:

    Authority: 14 U.S.C. 544; 43 U.S.C. 1333; 33 CFR 1.05-1;
Department of Homeland Security Delegation No. 00170.1, Revision No.
01.3.

0
2. Add Sec.  147.T01-0277 to read as follows:

Sec.  147.T01-0277  Safety Zones; Vineyard Wind 1 Wind Farm Project
Area, Outer Continental Shelf, Lease OCS-A 0501, Offshore
Massachusetts, Atlantic Ocean.

    (a) Description. The area within 500-meters of the center point of
the positions provided in the table 1 is a safety zone:

                                            Table 1 to Paragraph (a)
----------------------------------------------------------------------------------------------------------------
                     Name                                 Facility type              Latitude        Longitude
----------------------------------------------------------------------------------------------------------------
AL38..........................................  WTG.............................      41.1370161     -70.4638911
AM37..........................................  ESP.............................      41.1200616     -70.4851682
AM38..........................................  WTG.............................      41.1203387     -70.4635204
AM39..........................................  WTG.............................      41.1206168     -70.4414663
AN36..........................................  WTG.............................      41.1030927     -70.5072461
AN37..........................................  WTG.............................      41.1033791     -70.4851982
AN38..........................................  WTG.............................      41.1036612     -70.4631500
AN39..........................................  WTG.............................      41.1039392     -70.4411014
AP35..........................................  WTG.............................      41.0861251     -70.5289069
AP36..........................................  WTG.............................      41.0864155     -70.5068649
AP37..........................................  WTG.............................      41.0867017     -70.4848226
AP38..........................................  WTG.............................      41.0869837     -70.4627799
AP39..........................................  WTG.............................      41.0872615     -70.4407369
AP40..........................................  WTG.............................      41.0875351     -70.4186937
AP41..........................................  WTG.............................      41.0878044     -70.3966501
AQ34..........................................  WTG.............................      41.0691535     -70.5505566
AQ35..........................................  WTG.............................      41.0694480     -70.5285205
AQ36..........................................  WTG.............................      41.0697382     -70.5064840
AQ37..........................................  WTG.............................      41.0700243     -70.4844472
AQ38..........................................  WTG.............................      41.0703061     -70.4624101
AQ39..........................................  WTG.............................      41.0705837     -70.4403727
AQ40..........................................  WTG.............................      41.0708571     -70.4183350
AQ41..........................................  WTG.............................      41.0711263     -70.3962970
AQ42..........................................  WTG.............................      41.0713913     -70.3742587

AR33..........................................  WTG.............................      41.0521781     -70.5721951
AR34..........................................  WTG.............................      41.0524766     -70.5501649
AR35..........................................  WTG.............................      41.0527709     -70.5281343
AR36..........................................  WTG.............................      41.0530609     -70.5061034
AR37..........................................  WTG.............................      41.0533468     -70.4840722
AR38..........................................  WTG.............................      41.0536285     -70.4620407
AR39..........................................  WTG.............................      41.0539059     -70.4400088
AR40..........................................  WTG.............................      41.0541792     -70.4179767
AR41..........................................  WTG.............................      41.0544482     -70.3959442
AR42..........................................  WTG.............................      41.0547130     -70.3739115
AS32..........................................  WTG.............................      41.0351987     -70.5938225
AS33..........................................  WTG.............................      41.0355012     -70.5717982
AS34..........................................  WTG.............................      41.0357995     -70.5497735
AS35..........................................  WTG.............................      41.0360937     -70.5277485
AS36..........................................  WTG.............................      41.0363836     -70.5057231
AS37..........................................  WTG.............................      41.0366693     -70.4836975
AS38..........................................  WTG.............................      41.0369508     -70.4616715
AS39..........................................  WTG.............................      41.0372281     -70.4396452
AS40..........................................  WTG.............................      41.0375012     -70.4176186
AS41..........................................  WTG.............................      41.0377701     -70.3955918
AS42..........................................  WTG.............................      41.0380347     -70.3735646
AT33..........................................  WTG.............................      41.0188243     -70.5714016
AT34..........................................  WTG.............................      41.0191225     -70.5493824
AT35..........................................  WTG.............................      41.0194164     -70.5273630
AT36..........................................  WTG.............................      41.0197062     -70.5053432
AT37..........................................  WTG.............................      41.0199917     -70.4833231
AT38..........................................  WTG.............................      41.0202731     -70.4613027
AT39..........................................  WTG.............................      41.0205502     -70.4392819
AT40..........................................  WTG.............................      41.0208231     -70.4172609
AT41..........................................  WTG.............................      41.0210918     -70.3952396
AU36..........................................  WTG.............................      41.0030287     -70.5049636
AU37..........................................  WTG.............................      41.0033141     -70.4829490
AU38..........................................  WTG.............................      41.0035953     -70.4609341
AU39..........................................  WTG.............................      41.0038722     -70.4389190
AU40..........................................  WTG.............................      41.0041450     -70.4169035
AV37..........................................  WTG.............................      40.9866364     -70.4825752
AV38..........................................  WTG.............................      40.9869174     -70.4605659
AV39..........................................  WTG.............................      40.9871942     -70.4385563
AW38..........................................  WTG.............................      40.9702395     -70.4601980
----------------------------------------------------------------------------------------------------------------

    (b) Definitions. As used in this section, designated representative
means a Coast Guard Patrol Commander, including a Coast Guard coxswain,
petty officer, or other officer operating a Coast Guard vessel and a
Federal, State, and local officer designated by or assisting the First
Coast Guard District Commander in the enforcement of the safety zones.
    (c) Regulations. No vessel may enter or remain in the safety zones
described in paragraph (a) of this section except for the following:
    (1) An attending vessel as defined in 33 CFR 147.20;
    (2) A vessel authorized by the First Coast Guard District Commander
or a designated representative.
    (d) Request for Permission. Persons or vessels seeking to enter the
safety zone must request authorization from the First Coast Guard
District Commander or a designated representative. If permission is
granted, all persons and vessels must comply with lawful instructions
of the First Coast Guard District Commander or designated
representative via VHF-FM channel 16 or by phone at<PHONE_NUMBER> (First
Coast Guard District Command Center).
    (e) Effective and enforcement periods. This section will be
effective from June 15, 2023, through 11:59 p.m. on May 31, 2024. It
will only be enforced during active construction or other instances
which may cause a hazard to navigation deemed necessary by the First
Coast Guard District Commander. The First Coast Guard District
Commander will make notification of the exact dates and times in
advance of each enforcement period for the locations above in paragraph
(a) of this section to the local maritime community through the Local
Notice to Mariners and will issue a Broadcast Notice to Mariners via
marine channel 16 (VHF-FM) as soon as practicable in response to an
emergency. If the project is completed before May 31, 2024, enforcement
of the safety zones will be suspended, and notice given via Local
Notice to Mariners. The First Coast Guard District Local Notice to
Mariners can be found at: http://www.navcen.uscg.gov.

    Dated: April 27, 2023.
J.W. Mauger,
Rear Admiral, U.S. Coast Guard, Commander, First Coast Guard District.
[FR Doc. 2023-09415 Filed 5-2-23; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 76, Number 87 (Thursday, May 5, 2011)]
[Rules and Regulations]
[Pages 25535-25537]
[FR Doc No: 2011-10690]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2010-1306; Directorate Identifier 2010-NM-112-AD;
Amendment 39-16682; AD 2011-10-01]
RIN 2120-AA64

Airworthiness Directives; Dassault-Aviation Model FALCON 7X
Airplanes

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Final rule.

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

SUMMARY: We are adopting a new airworthiness directive (AD) for the
products listed above. This AD results from mandatory continuing
airworthiness information (MCAI) originated by an aviation authority of
another country to identify and correct an unsafe condition on an
aviation product. The MCAI describes the unsafe condition as:

    A design review has revealed a potential dormant failure of the
Ram Air Turbine (RAT) heating system. If this failure occurs, it
could lead to the freezing of the RAT mechanism [the potential
consequence of this heater being inoperative relates primarily to
generator rotor/turbine assembly rotation--either the ability to
rotate or to rotate at rated RPM for a given airspeed], and the
consequent * * * [non-functioning] of the RAT when needed.

* * * * *
Non-functioning of the RAT could result in insufficient electrical
power to operate the fly-by-wire system, and subsequent loss of control
of the airplane. We are issuing this AD to require actions to correct
the unsafe condition on these products.

DATES: This AD becomes effective June 9, 2011.

ADDRESSES: You may examine the AD docket on the Internet at http://www.regulations.gov or in person at the U.S. Department of
Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue, SE., Washington, DC.

FOR FURTHER INFORMATION CONTACT: Tom Rodriguez, Aerospace Engineer,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
1601 Lind Avenue, SW., Renton, Washington 98057-3356; telephone (425)
227-1137; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 to include an AD that would apply to the specified products.
That NPRM was published in the Federal Register on January 5, 2011 (76
FR 480). That NPRM proposed to correct an unsafe condition for the
specified products. The MCAI states:

    A design review has revealed a potential dormant failure of the
Ram Air Turbine (RAT) heating system. If this failure occurs, it
could lead to the freezing of the RAT mechanism [the potential
consequence of this heater being inoperative relates primarily to
generator rotor/turbine assembly rotation--either the ability to
rotate or to rotate at rated RPM for a given airspeed], and the
consequent * * * [non-functioning] of the RAT when needed.
    The purpose of this AD is to require a repetitive functional
test of the RAT heater * * *.

    Non-functioning of the RAT could result in insufficient electrical
power to operate the fly-by-wire system, and subsequent loss of control
of the airplane. The corrective action is repairing. You may obtain
further information by examining the MCAI in the AD docket.

Comments

    We gave the public the opportunity to participate in developing
this AD. We considered the comment received.

Request To Rephrase Summary and Reason Sections of the NPRM

    Hamilton Sundstrand requested that we rephrase the Summary and
Reason sections of the NPRM regarding the potential for RAT non-
deployment due to freezing of the RAT mechanism. The commenter stated
that the malfunction of the RAT heating system would not in itself
prevent RAT deployment. The commenter stated that the heating system
consists of only the RAT heater within the generator, and the potential
consequence of this heater being inoperative relates primarily to
freezing of the gap between the rotor and stator of the generator
rotor/turbine assembly, leading to the RAT generator inability to
rotate or to rotate at rated rotations per minute (RPM) for a given
airspeed.
    We agree to rephrase the Summary and Reason sections of the AD, as
well as paragraph (e) of this AD, although the end result of the heater
issue results in the identified insufficient electrical power to
operate the fly-by-wire system, and subsequent loss of control of the
airplane.

Conclusion

    We reviewed the available data, including the comment received, and
determined that air safety and the public interest require adopting the
AD with the changes described previously. We determined that these
changes will not increase the economic burden on any operator or
increase the scope of the AD.

Differences Between This AD and the MCAI or Service Information

    We have reviewed the MCAI and related service information and, in
general, agree with their substance. But we might have found it
necessary to use different words from those in the MCAI to ensure the
AD is clear for U.S. operators and is enforceable. In making these
changes, we do not intend to differ substantively from the information
provided in the MCAI and related service information.
    We might also have required different actions in this AD from those
in the MCAI in order to follow our FAA policies. Any such differences
are highlighted in a NOTE within the AD.

Costs of Compliance

    We estimate that this AD will affect 21 products of U.S. registry.
We also estimate that it will take about 1 work-hour per product to
comply with the basic requirements of this AD. The average labor rate
is $85 per work-hour. Based on these figures, we estimate the cost of
this AD to the U.S. operators to be $1,785, or $85 per product.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. ``Subtitle VII: Aviation
Programs,'' describes in more detail the scope of the Agency's
authority.
    We are issuing this rulemaking under the authority described in
``Subtitle VII, Part A, Subpart III, Section 44701: General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    We determined that this AD will not have federalism implications
under Executive Order 13132. This AD will not have a substantial direct
effect on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government.
    For the reasons discussed above, I certify this AD:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979); and
    3. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    We prepared a regulatory evaluation of the estimated costs to
comply with this AD and placed it in the AD docket.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov; or in person at the Docket Operations office
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains the NPRM, the regulatory evaluation,
any comments received, and other information. The street address for
the Docket Operations office (telephone<PHONE_NUMBER>) is in the
ADDRESSES section. Comments will be available in the AD docket shortly
after receipt.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

Adoption of the Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority:  49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new AD:

2011-10-01 Dassault-Aviation: Amendment 39-16682. Docket No. FAA-
2010-1306; Directorate Identifier 2010-NM-112-AD.

Effective Date

    (a) This airworthiness directive (AD) becomes effective June 9,
2011.

Affected ADs

    (b) None.

Applicability

    (c) This AD applies to Dassault-Aviation Model FALCON 7X
airplanes, certificated in any category, all serial numbers.

Subject

    (d) Air Transport Association (ATA) of America Code 24:
Electrical power.

Reason

    (e) The mandatory continuing airworthiness information (MCAI)
states:
    A design review has revealed a potential dormant failure of the
Ram Air Turbine (RAT) heating system. If this failure occurs, it
could lead to the freezing of the RAT mechanism [the potential
consequence of this heater being inoperative relates primarily to
generator rotor/turbine assembly rotation--either the ability to
rotate or to rotate at rated RPM for a given airspeed], and the
consequent * * * [non-functioning] of the RAT when needed.
* * * * *
Non-functioning of the RAT could result in insufficient electrical
power to operate the fly-by-wire system, and subsequent loss of
control of the airplane.

Compliance

    (f) You are responsible for having the actions required by this
AD performed within the compliance times specified, unless the
actions have already been done.

Actions

    (g) At the applicable times specified in paragraph (g)(1) or
(g)(2) of this AD, do a functional test of the RAT heater using a
method approved by either the Manager,

International Branch, ANM-116, Transport Airplane Directorate, FAA;
or the European Aviation Safety Agency (EASA) (or its delegated
agent). Repeat the functional test of the RAT heater thereafter at
the applicable time specified in paragraph (g)(1) or (g)(2) of this
AD. If any functional test fails, before further flight, repair
using a method approved by either the Manager, International Branch,
ANM-116, Transport Airplane Directorate, FAA; or EASA (or its
delegated agent).
    (1) For Falcon 7X airplanes on which modification M0305 has not
been done and on which Dassault Service Bulletin 7X-018, dated March
6, 2009, has not been done: Within 650 flight hours after the
effective date of this AD, do a functional test of the RAT heater
and repeat the functional test of the RAT heater thereafter at
intervals not to exceed 650 flight hours.
    (2) For Falcon 7X airplanes on which modification M0305 has been
done or on which Dassault Service Bulletin 7X-018, dated March 6,
2009, has been done: Within 1,900 flight hours after the effective
date of this AD or after modification M0305 or Dassault Service
Bulletin 7X-018, dated March 6, 2009, has been done, whichever
occurs later, do a functional test of the RAT heater. Repeat the
functional test of the RAT heater thereafter at intervals not to
exceed 1,900 flight hours.

    Note 1: Additional guidance for doing the functional test of the
RAT heater required by paragraph (g) of this AD can be found in Task
24-50-25-720-801, Functional Test of the RAT Heater, dated January
16, 2009, of the Dassault Falcon 7X Aircraft Maintenance Manual
(AMM).

FAA AD Differences

    Note 2: This AD differs from the MCAI and/or service information
as follows:
    (1) The MCAI provides an option of inserting the MCAI into
Chapter 5-40 of the Dassault Falcon 7X AMM, pending publication of
the revised Chapter 5-40 of the Dassault Falcon 7X AMM. This AD does
not have that option.
    (2) The MCAI requires doing the actions in accordance with Task
24-50-25-720-801 of Chapter 5-40, of the Dassault Falcon 7X AMM.
However, this AD requires that the actions be done using a method
approved by the FAA or EASA (or its delegated agent).

Other FAA AD Provisions

    (h) The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Branch, ANM-116, FAA, has the authority to approve
AMOCs for this AD, if requested using the procedures found in 14 CFR
39.19. In accordance with 14 CFR 39.19, send your request to your
principal inspector or local Flight Standards District Office, as
appropriate. If sending information directly to the International
Branch, send it to ATTN: Tom Rodriguez, Aerospace Engineer,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
1601 Lind Avenue, SW., Renton, Washington 98057-3356; telephone
(425) 227-1137; fax<PHONE_NUMBER>. Information may be e-mailed to:
<EMAIL_ADDRESS>Before using any approved AMOC,
notify your appropriate principal inspector, or lacking a principal
inspector, the manager of the local flight standards district
office/certificate holding district office. The AMOC approval letter
must specifically reference this AD.
    (2) Airworthy Product: For any requirement in this AD to obtain
corrective actions from a manufacturer or other source, use these
actions if they are FAA-approved. Corrective actions are considered
FAA-approved if they are approved by the State of Design Authority
(or their delegated agent). You are required to assure the product
is airworthy before it is returned to service.

Related Information

    (i) Refer to MCAI EASA Airworthiness Directive 2010-0033, dated
March 3, 2010, for related information.

Material Incorporated by Reference

    (j) None.

    Issued in Renton, Washington, on April 20, 2011.
Kalene C. Yanamura,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2011-10690 Filed 5-4-11; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 78, Number 29 (Tuesday, February 12, 2013)]
[Proposed Rules]
[Pages 9866-9869]
[FR Doc No: 2013-03122]

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

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 100

[Docket Number USCG-2013-0015]
RIN 1625-AA08

Special Local Regulation; Moss Point Rockin' the Riverfront
Festival; Robertson Lake & O'Leary Lake; Moss Point, MS

AGENCY: Coast Guard, DHS.

ACTION: Notice of Proposed Rulemaking.

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

SUMMARY: The Coast Guard proposes to establish a temporary special
local regulation for a portion of Robertson Lake & O'Leary Lake, Moss
Point, MS. This action is necessary for the safeguard of participants
and spectators, including all crews, vessels, and persons on navigable
waters during the Moss Point Rockin' the Riverfront Festival high speed
boat races. Entry into, transiting or anchoring in this area is
prohibited to all vessels not registered with the sponsor as
participants or not part of the regatta patrol, unless specifically
authorized by the Captain of the Port (COTP) Mobile or a designated
representative.

DATES: Comments and related material must be received by the Coast
Guard on or before March 14, 2013.
    This proposed rule will be effective and enforceable with actual
notice from 11:00 a.m. until 4:00 p.m. on April 27-28, 2013.

ADDRESSES: You may submit comments identified by docket number USCG-
2013-0015 using any one of the following methods:
    (1) Federal eRulemaking Portal: http://www.regulations.gov
    (2) Fax:<PHONE_NUMBER>.
    (3) Mail: Docket Management Facility (M-30), U.S. Department of
Transportation, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590-0001. Deliveries accepted
between 9 a.m. and 5 p.m., Monday through Friday, except federal
holidays. The telephone number is<PHONE_NUMBER>.

    See the ``Public Participation and Request for Comments'' portion
of the SUPPLEMENTARY INFORMATION section below for further instructions
on submitting comments. To avoid duplication, please use only one of
these three methods.

FOR FURTHER INFORMATION CONTACT: If you have questions on this proposed
rule, call or email LT Lenell J. Carson, Coast Guard Sector Mobile,
Waterways Management Division; telephone<PHONE_NUMBER> or email
<EMAIL_ADDRESS>If you have questions on viewing or
submitting material to the docket, call Renee V. Wright, Program
Manager, Docket Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Table of Acronyms

DHS Department of Homeland Security
FR Federal Register
NPRM Notice of Proposed Rulemaking
COTP Captain of the Port

A. Public Participation and Request for Comments

    We encourage you to participate in this rulemaking by submitting
comments and related materials. All comments received will be posted
without change to http://www.regulations.gov and will include any
personal information you have provided.

1. Submitting comments

    If you submit a comment, please include the docket number for this
proposed rulemaking (USCG-2013-0015), indicate the specific section of
this document to which each comment applies, and provide a reason for
each suggestion or recommendation. You may submit your comments and
material online at http://www.regulations.gov, or by fax, mail, or hand
delivery, but please use only one of these means. If you submit a
comment online, it will be considered received by the Coast Guard when
you successfully transmit the comment. If you fax, hand deliver, or
mail your comment, it will be considered as having been received by the
Coast Guard when it is received at the Docket Management Facility. We
recommend that you include your name and a mailing address, an email
address, or a telephone number in the body of your document so that we
can contact you if we have questions regarding your submission.
    To submit your comment online, go to http://www.regulations.gov,
type the docket number (USCG-2013-0015) in the ``SEARCH'' box and click
``SEARCH.'' Click on ``Submit a Comment'' on the line associated with
this rulemaking.
    If you submit your comments by mail or hand delivery, submit them
in an unbound format, no larger than 8\1/2\ by 11 inches, suitable for
copying and electronic filing. If you submit comments by mail and would
like to know that they reached the Facility, please enclose a stamped,
self-addressed postcard or envelope. We will consider all comments and
material received during the comment period and may change the proposed
rule based on your comments.

2. Viewing Comments and Documents

    To view comments, as well as documents mentioned in this preamble
as being available in the docket, go to http://www.regulations.gov,
type the docket number (USCG-2013-0015) in the ``SEARCH'' box and click
``SEARCH.'' Click on Open Docket Folder on the line associated with
this rulemaking. You may also visit the Docket Management Facility in
Room W12-140 on the ground floor of the Department of Transportation
West Building, 1200 New Jersey Avenue SE., Washington, DC 20590,
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays.

3. Privacy Act

    Anyone can search the electronic form of 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 a Privacy Act notice
regarding our public dockets in the January 17, 2008, issue of the
Federal Register (73 FR 3316).

4. Public Meeting

    We do not now plan to hold a public meeting. But you may submit a
request for one, using one of the methods specified under ADDRESSES.
Please explain why you believe a public meeting would be beneficial. If
we determine that one would aid this proposed rulemaking, we will hold
one at a time and place announced by a later notice in the Federal
Register.

B. Regulatory History and Information

    The Coast Guard previously created a temporary special local
regulation for this event when it was held in 2012. That rule was
published in the Federal Register on March 14, 2012 (77 FR 14963), and
the requirements of that rule are the same as those in this proposed
rule.

C. Basis and Purpose

    The Moss Point Main Street Association applied for a Marine Event
Permit to conduct a high speed boat race on Robertson Lake & O'Leary
Lake, Moss Point, MS on April 27-28, 2013. This event will draw in a
large number of pleasure craft and the high speed boats pose a
significant safety hazard to both vessels and mariners operating in or
near the area. The COTP Mobile proposes to establish a temporary
special local regulation for a portion of Robertson Lake & O'Leary
Lake, Moss Point, MS. This proposed temporary special local regulation
is deemed necessary to safeguard persons and vessels during the high
speed boat races. The legal basis and authorities for this proposed
rule are found in 33 U.S.C. 1233 and 33 CFR part 100, which authorizes
the Coast Guard to propose, establish, and define regulatory special
local regulations for safety during marine events.
    The COTP anticipates minimal impact on vessel traffic due to this
proposed regulation. However, the proposed temporary special local
regulation is deemed necessary for the safeguard of life and property
within the COTP Mobile zone.

D. Discussion of Proposed Rule

    The Coast Guard proposes to establish a temporary special local
regulation for a portion of Robertson Lake & O'Leary Lake, Moss Point,
MS, enclosed by a bounded area starting at a point on the shore at
approximately 30[deg] 25' 11.0'' N, 088 32' 24.4'' W, then east to
30[deg] 25' 12.9'' N, 088 32' 18.0'' W, then south to 30[deg] 24'
50.9'' N, 088 32' 09.6'' W, then west following the shore line back to
the starting point at 30[deg] 25' 11.0'' N, 088 32' 24.4'' W. This
temporary rule will safeguard life and property in this area. Entry
into, transiting or anchoring in this zone is prohibited to all vessels
not registered with the sponsor as participants or not part of the
regatta patrol, unless specifically authorized by the COTP Mobile or a
designated representative. They may be contacted on VHF-FM Channel 16
or through Coast Guard Sector Mobile at<PHONE_NUMBER>.
    The COTP Mobile or a designated representative will inform the
public through broadcast notice to mariners of changes in the effective
period for the proposed temporary special local regulation. This
proposed rule will be effective from 11:00 a.m. until 4:00 p.m. on
April 27-28, 2013.

E. Regulatory Analyses

    We developed this proposed rule after considering numerous statutes
and

executive orders related to rulemaking. Below we summarize our analyses
based on a number of these statutes or executive orders.

1. Regulatory Planning and Review

    This proposed rule is not a significant regulatory action under
section 3(f) of Executive Order 12866, Regulatory Planning and Review,
as supplemented by Executive Order 13563, Improving Regulation and
Regulatory Review, and does not require an assessment of potential
costs and benefits under section 6(a)(3) of Executive Order 12866 or
under section 1 of Executive Order 13563. The Office of Management and
Budget has not reviewed it under those Orders.
    The temporary special local regulation listed in this proposed rule
will only restrict vessel traffic from entering or transiting a small
portion of Robertson Lake & O'Leary Lake, Moss Point, MS. The effect of
this regulation will not be significant for several reasons: (1) This
rule will only affect vessel traffic for a short duration; (2) vessels
may request permission from the COTP to transit through the regulated
area; and (3) the impacts on routine navigation are expected to be
minimal. Notifications to the marine community will be made through
Local Notice to Mariners and Broadcast Notice to Mariners. These
notifications will allow the public to plan operations around the
affected area.

2. Impact on Small Entities

    The Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601-612, as
amended, requires federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this
proposed rule will not have a significant economic impact on a
substantial number of small entities. This proposed rule will affect
the following entities, some of which may be small entities: the owners
or operators of vessels intending to transit or anchor in the affected
portion of the Robertson Lake & O'Leary Lake during the high speed boat
races. This proposed temporary special local regulation will not have a
significant economic impact on a substantial number of small entities
for the following reasons. The regulated area is limited in size, is of
short duration and vessel traffic may request permission from the COTP
Mobile or a designated representative to enter or transit through the
regulated area.
    If you think that your business, organization, or governmental
jurisdiction qualifies as a small entity and that this proposed rule
would have a significant economic impact on it, please submit a comment
(see ADDRESSES) explaining why you think it qualifies and how and to
what degree this proposed rule would economically affect it.

3. Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this proposed rule. If the proposed rule
would affect your small business, organization, or governmental
jurisdiction and you have questions concerning its provisions or
options for compliance, please contact the person listed in the FOR
FURTHER INFORMATION CONTACT, above. The Coast Guard will not retaliate
against small entities that question or complain about this proposed
rule or any policy or action of the Coast Guard.

4. Collection of Information

    This proposed rule will not call for a new collection of
information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520).

5. Federalism

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on the States on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government. We have analyzed this proposed rule under that Order and
have determined that it does not have implications for federalism.

6. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to contact the person listed in the For Further
Information Contact section to coordinate protest activities so that
your message can be received without jeopardizing the safety or
security of people, places or vessels.

7. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this proposed rule would not
result in such expenditure, we do discuss the effects of this proposed
rule elsewhere in this preamble.

8. Taking of Private Property

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

9. Civil Justice Reform

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

10. Protection of Children From Environmental Health Risks

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

11. Indian Tribal Governments

    This proposed rule does not have tribal implications under
Executive Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it would not have a substantial direct effect on
one or more Indian tribes, on the relationship between the Federal
Government and Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes.

12. Energy Effects

    This proposed rule is not a ``significant energy action'' under
Executive Order 13211, Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use.

13. Technical Standards

    This proposed rule does not use technical standards. Therefore, we
did not consider the use of voluntary consensus standards.

14. Environment

    We have analyzed this proposed rule under Department of Homeland
Security Management Directive 023-01

and Commandant Instruction M16475.lD, which guide the Coast Guard in
complying with the National Environmental Policy Act of 1969 (NEPA)(42
U.S.C. 4321-4370f), and have made a preliminary determination that this
action is one of a category of actions which do not individually or
cumulatively have a significant effect on the human environment. This
proposed rule involves safety for the public and is not expected to
result in any significant adverse environmental impact as described in
NEPA. This rule is categorically excluded from further review under
paragraph 34(h) of Figure 2-1 of the Commandant Instruction. A
preliminary environmental analysis checklist supporting this
determination and a Categorical Exclusion Determination are available
in the docket where indicated under ADDRESSES. We seek any comments or
information that may lead to the discovery of a significant
environmental impact from this proposed rule.

List of Subjects 33 CFR Part 100

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

    For the reasons discussed in the preamble, the Coast Guard proposes
to amend 33 CFR part 100 as follows:

PART 100--SAFETY OF LIFE ON NAVIGABLE WATERS

0
1. The authority citation for part 100 continues to read as follows:

    Authority: 33 U.S.C. 1233.

0
2. Add Sec.  100.T08-0015 to read as follows:

Sec.  100.T08-0015  Special Local Regulation; Moss Point Rockin' the
Riverfront Festival; Robertson Lake & O'Leary Lake; Moss Point, MS.

    (a) Location. The following area is a regulated area: a portion of
Robertson Lake & O'Leary Lake, Moss Point, MS, enclosed by a bounded
area starting at a point on the shore at approximately 30[deg] 25'
11.0'' N, 088 32' 24.4'' W, then east to 30[deg] 25' 12.9'' N, 088 32'
18.0'' W, then south to 30[deg] 24' 50.9'' N, 088 32' 09.6'' W, then
west following the shore line back to the starting point at 30[deg] 25'
11.0'' N, 088 32' 24.4'' W.
    (b) Enforcement dates. This rule will be enforced from 11:00 a.m.
until 4:00 p.m. on April 27-28, 2013.
    (c) Special Local Regulations.
    (1) The Coast Guard will patrol the regulated area under the
direction of a designated Coast Guard Patrol Commander. The Patrol
Commander may be contacted on Channel 16 VHF-FM (156.8 MHz) by the call
sign ``PATCOM''.
    (2) All Persons and vessels not registered with the sponsor as
participants or official patrol vessels are considered spectators. The
``official patrol vessels'' consist of any Coast Guard, state, or local
law enforcement and sponsor provided vessels assigned or approved by
the Captain of the Port Mobile to patrol the regulated area.
    (3) Spectator vessels desiring to transit the regulated area may do
so only with prior approval of the Patrol Commander and when so
directed by that officer and will be operated at a minimum safe
navigation speed in a manner which will not endanger participants in
the regulated area or any other vessels.
    (4) No spectator shall anchor, block, loiter, or impede the through
transit of participants or official patrol vessels in the regulated
area during the effective dates and times, unless cleared for entry by
or through an official patrol vessel.
    (5) The patrol commander may forbid and control the movement of all
vessels in the regulated area. When hailed or signaled by an official
patrol vessel, a vessel shall come to an immediate stop and comply with
the directions given. Failure to do so may result in expulsion from the
area, citation for failure to comply, or both.
    (6) Any spectator vessel may anchor outside the regulated area, but
may not anchor in, block, or loiter in a navigable channel. Spectator
vessels may be moored to a waterfront facility within the regulated
area in such a way that they shall not interfere with the progress of
the event. Such mooring must be complete at least 30 minutes prior to
the establishment of the regulated area and remain moored through the
duration of the event.
    (7) The Patrol Commander may terminate the event or the operation
of any vessel at any time it is deemed necessary for the protection of
life or property.
    (8) The Patrol Commander will terminate enforcement of the special
local regulations at the conclusion of the event.
    (d) Informational Broadcasts. The Captain of the Port or a
designated representative will inform the public through broadcast
notices to mariners of the enforcement period for the regulated area as
well as any changes in the planned schedule.

    Dated: January 21, 2013.
D.J. Rose,
Captain, U.S. Coast Guard, Captain of the Port Mobile.
[FR Doc. 2013-03122 Filed 2-11-13; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 86, Number 28 (Friday, February 12, 2021)]
[Notices]
[Page 9336]
[FR Doc No: 2021-02963]

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ENVIRONMENTAL PROTECTION AGENCY

[FRL10020-16-Region 3]

Clean Air Act Operating Permit Program; Petition To Object to the
Title V Permit for Northampton Generating Co., LP; Pennsylvania

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of final action.

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

SUMMARY: Pursuant to the Clean Air Act (CAA), the Environmental
Protection Agency (EPA) Administrator signed an Order, dated July 15,
2020, partially granting and partially denying a petition to object to
a state operating permit issued by the Pennsylvania Department of
Environment Protection (PADEP). The Order responds to a January 8, 2020
petition, relating to Northampton Generating Co., LP's Northampton
Plant (Northampton), an electric utility generation facility located in
Northampton County, Pennsylvania. The petition was submitted by the
Sierra Club and the Clean Air Council. This Order constitutes final
action on that petition requesting that the Administrator object to the
issuance of the proposed CAA title V permit.

DATES: February 12, 2021.

ADDRESSES: Copies of the final Order, the petition, and all pertinent
information relating thereto can be requested by electronic mail to the
address set forth below in the FOR FURTHER INFORMATION CONTACT section.
The final Order is also available electronically at the following
website: https://www.epa.gov/title-v-operating-permits/title-v-petition-database.

FOR FURTHER INFORMATION CONTACT: Emily Bertram, Permits Branch, Air and
Radiation Division, EPA Region III,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The CAA affords EPA a 45-day period to
review and object to, as appropriate, operating permits proposed by
state permitting authorities. Section 505(b)(2) of the CAA authorizes
any person to petition the EPA Administrator within 60 days after the
expiration of this review period to object to a state operating permit
if EPA has not done so. Petitions must be based only on objections
raised with reasonable specificity during the public comment period,
unless the petitioner demonstrates that it was impracticable to raise
these issues during the comment period or that the grounds for
objection or other issue arose after the comment period.
    In the Northampton petition (numbered III-2020-1), the Petitioners
sought EPA objection on the following issues: (Claim I) the Northampton
permit's monitoring regime did not ensure that emissions restrictions
are met; (Claim II) PADEP erred in allowing Northampton to modify its
permit using the less stringent minor modification process. PADEP
issued the final Northampton operating permit (permit No. 48-00021) on
December 16, 2019.
    The Order explains the reasons behind EPA's decision to partially
grant and partially deny the petition for objection. Pursuant to
section 505(b)(2) of the CAA, the Petitioner may seek judicial review
of those portions of the Northampton petition which EPA denied in the
United States Court of Appeals for the appropriate circuit. Any
petition for review shall be filed within 60 days of this notice in
accordance with the requirements of section 307 of the CAA.

    Dated: February 8, 2021.
Cristina Fernandez,
Director, Air and Radiation Division, Region III.
[FR Doc. 2021-02963 Filed 2-11-21; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 77, Number 108 (Tuesday, June 5, 2012)]
[Notices]
[Pages 33212-33213]
[FR Doc No: 2012-13504]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. UL11-1-000]

Turlock Irrigation District; Notice of Availability of
Navigability Report for the Tuolumne River, Request for Comments, and
Notice of Pending Jurisdictional Inquiry

    On June 10, 2011, the Federal Energy Regulatory Commission
(Commission) received an inquiry from the National Marine Fisheries
Service, National Oceanic and Atmospheric Administration, concerning
the status of the unlicensed La Grange Hydroelectric Project. The
project is located on the Tuolumne River near the town of La Grange in
Tuolumne County, California.
    As part of its review, Commission staff is investigating the
jurisdictional status of the project and has prepared a navigability
report for the Tuolumne River. Before making its decision, staff will
accept and consider comments on the navigability report. Comments may
be filed no later July 2, 2012.
    Section 23(b)(1) of the Federal Power Act (FPA) requires a
Commission license for the construction, operation, or maintenance of
hydropower projects which: (1) Are located on navigable waters of the
United States; (2) occupy public lands or reservations of the United
States; (3) utilize the surplus

water or water power from a federal dam; \1\ or (4) are located on non-
navigable streams over which Congress has jurisdiction under its
authority to regulate interstate and foreign commerce, would affect the
interests of interstate or foreign commerce (such as by connection to
the interstate electrical grid, and are constructed or enlarged after
August 26, 1935.
---------------------------------------------------------------------------

    \1\ Licensing is not required under conditions 1, 2, or 3 above
if the project is constructed, operated, and maintained in
accordance with the terms of a valid federal permit issued prior to
June 10, 1920.
---------------------------------------------------------------------------

    A stream is navigable under section 3(8) of the FPA if: (1) It is
currently being used or is suitable for use, or (2) it has been used or
was suitable for use in the past, or (3) it could be made suitable for
use in the future by reasonable improvements, to transport persons or
property in interstate or foreign commerce. Navigability under section
3(8) of the FPA is not destroyed by obstructions or disuse of many
years; personal or private use may be sufficient to demonstrate the
availability of the river for commercial navigation; and the seasonal
floatation of logs is sufficient to determine that a river is
navigable.
    Comments are invited on the staff's navigability report. Copies of
this navigability report are on file with the Commission and are
available for public inspection. This navigability report may be viewed
on the web at http://www.ferc.gov using the ``eLibrary'' link. Enter
the docket number, UL11-1, excluding the last three digits in the
docket number field to access the document. You may also register
online at http://www.ferc.gov/docs-filing/esubscription.asp to be
notified via email of new filings and issuances related to this or
other pending projects. For assistance, please contact FERC Online
Support at<EMAIL_ADDRESS>or toll-free at<PHONE_NUMBER>,
or TTY, contact<PHONE_NUMBER>.
    Please file your response with the Commission's Secretary by July
2, 2012. All comments may be filed electronically via the Internet. See
18 CFR 385.2001(a)(1)(iii) and the instructions on the Commission's web
site at http://www.ferc.gov under the ``e-Filing'' link. If unable to
be filed electronically, comments may be paper-filed. To paper-file, an
original and eight copies should be filed with: Secretary, Mail Code
PJ-12, Federal Energy Regulatory Commission, 888 First Street NE.,
Washington, DC 20426. For more information on how to submit these types
of filings, please go to the Commission's Web site at http://www.ferc.gov.filing-comments.asp. Please include the docket number
(UL11-1-000) on any filing.
    For further information, please contact Henry Ecton at (202) 502-
8768.

    Dated: May 29, 2012.
Kimberly D. Bose,
Secretary.
[FR Doc. 2012-13504 Filed 6-4-12; 8:45 am]
BILLING CODE 6717-01-P