[Federal Register Volume 86, Number 168 (Thursday, September 2, 2021)]
[Notices]
[Pages 49321-49323]
[FR Doc No: 2021-18967]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP21-44-000]

LA Storage, LLC; Notice of Intent To Prepare an Environmental
Impact Statement for the Proposed Hackberry Storage Project, Request
for Comments on Environmental Issues, and Schedule for Environmental
Review

    The staff of the Federal Energy Regulatory Commission (FERC or
Commission) will prepare an environmental impact statement (EIS) that
will discuss the environmental impacts of the Hackberry Storage Project
(Project) involving construction and operation of facilities by LA
Storage, LLC (LA Storage) in Cameron and Calcasieu Parishes, Louisiana.
The Commission will use the EIS in its decision-making process to
determine whether LA Storage's proposed Project is in the public
convenience and necessity. The schedule for preparation of the EIS is
discussed in the Schedule for Environmental Review section of this
notice.
    As part of the National Environmental Policy Act (NEPA) review
process, the Commission takes into account concerns the public may have
about proposals and the environmental impacts that could result
whenever it considers the issuance of a Certificate of Public
Convenience and Necessity. This gathering of public input is referred
to as ``scoping.'' By notice issued on October 20, 2020, in Docket No.
PF20-5-000, the Commission opened a scoping period during LA Storage's
planning process for the Project and prior to filing a formal
application with the Commission, a process referred to as ``pre-
filing.'' LA Storage has now filed an application with the Commission,
and staff intends to prepare an EIS that will address the concerns
raised during the pre-filing scoping process as well as comments
received in response to this notice. Therefore, the Commission requests
comments on potential alternatives and impacts, and any relevant
information, studies, or analyses of any kind concerning impacts
affecting the quality of the human environment. To ensure that your
comments are timely and properly recorded, please submit your comments
so that the Commission receives them in Washington, DC on or before
5:00 p.m. Eastern Time on September 26, 2021. Further details on how to
submit comments are provided in the Public Participation section of
this notice.
    As mentioned above, during the pre-filing process, the Commission
opened a scoping period which expired on November 19, 2020; however,
Commission staff continued to accept comments during the entire pre-
filing process. All substantive written and oral comments provided
during pre-filing will be considered during the preparation of the EIS.
Therefore, if you submitted comments on this Project to the Commission
during the pre-filing process in Docket No. PF20-5-000 you do not need
to file those comments again.
    If you are a landowner receiving this notice, a pipeline company
representative may contact you about the acquisition of an easement to
construct, operate, and maintain the proposed facilities. The company
would seek to negotiate a mutually acceptable easement agreement. You
are not required to enter into an agreement. However, if the Commission
approves the Project, the Natural Gas Act conveys the right of eminent
domain to the company. Therefore, if you and the company do not reach
an easement agreement, the pipeline company could initiate condemnation
proceedings in court. In such instances, compensation would be
determined by a judge in accordance with state law. The Commission does
not grant, exercise, or oversee the exercise of eminent domain
authority. The courts have exclusive authority to handle eminent domain
cases; the Commission has no jurisdiction over these matters.
    LA Storage provided landowners with a fact sheet prepared by the
FERC entitled ``An Interstate Natural Gas Facility On My Land? What Do
I Need To Know?'' which addresses typically asked questions, including
the use of eminent domain and how to participate in the Commission's
proceedings. This fact sheet along with other landowner topics of
interest are available for viewing on the FERC website (www.ferc.gov)
under the Natural Gas Questions or Landowner Topics link.

Public Participation

    There are three methods you can use to submit your comments to the
Commission. The Commission encourages electronic filing of comments and
has staff available to assist you at<PHONE_NUMBER> or
<EMAIL_ADDRESS>Please carefully follow these instructions
so that your comments are properly recorded.
    (1) You can file your comments electronically using the eComment
feature, which is located on the Commission's website (www.ferc.gov)
under the link to FERC Online. Using eComment is an easy method for
submitting brief, text-only comments on a project;
    (2) You can file your comments electronically by using the eFiling
feature, which is located on the Commission's website (www.ferc.gov)
under the link to FERC Online. With eFiling, you can provide comments
in a variety of formats by attaching them as a file with your
submission. New eFiling users must first create an account by clicking
on ``eRegister.'' You will be asked to select the type of filing you
are making; a comment on a particular project is considered a ``Comment
on a Filing''; or
    (3) You can file a paper copy of your comments by mailing them to
the Commission. Be sure to reference the project docket number (CP21-
44-000) on your letter. Submissions sent via the U.S. Postal Service
must be addressed to: Kimberly D. Bose, Secretary, Federal Energy
Regulatory Commission, 888 First Street NE, Room 1A, Washington, DC
20426. Submissions sent via any other carrier must be addressed to:
Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission,
12225 Wilkins Avenue, Rockville, MD 20852.
    Additionally, the Commission offers a free service called
eSubscription. This service provides automatic notification of filings
made to subscribed dockets, document summaries, and direct links to the
documents. Go to https://www.ferc.gov/ferc-online/overview to register
for eSubscription.

Summary of the Proposed Project, the Project Purpose and Need, and
Expected Impacts

    The Project would involve the conversion of three existing salt
dome caverns to natural gas storage service and the development of one
new salt dome cavern for additional natural gas storage service, all
within a permanent natural gas storage facility on a 160-acre tract of
land owned by LA Storage. In addition to the storage caverns, LA
Storage would construct and operate on-site compression facilities
(Pelican Compressor Station) and up to six solution mining water supply
wells at the storage facility on LA Storage's property; the Hackberry
Pipeline, consisting of approximately 11.1 miles of 42-inch-diameter
natural gas pipeline connecting the certificated Port Arthur

Pipeline Louisiana Connector (PAPLC) pipeline (CP18-7) to the natural
gas storage caverns; the Cameron Interstate Pipeline (CIP) Lateral, an
approximately 4.9-mile-long, 42-inch-diameter natural gas pipeline
extending from the existing CIP to the planned natural gas storage
caverns; metering and regulating at the CIP and PAPLC interconnects;
and an approximately 6.2-mile-long, 16-inch-diameter brine disposal
pipeline that would transport brine from the caverns to four saltwater
disposal wells located on two pads north of the facility.
    The general location of the project facilities is shown in appendix
1.\1\
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    \1\ The appendices referenced in this notice will not appear in
the Federal Register. Copies of the appendices were sent to all
those receiving this notice in the mail and are available at
www.ferc.gov using the link called ``eLibrary.'' For instructions on
connecting to eLibrary, refer to the last page of this notice. At
this time, the Commission has suspended access to the Commission's
Public Reference Room due to the proclamation declaring a National
Emergency concerning the Novel Coronavirus Disease (COVID-19),
issued by the President on March 13, 2020. For assistance, contact
FERC at [email protected] or call toll free,<PHONE_NUMBER>
or TTY<PHONE_NUMBER>.
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    Construction of the planned facilities would disturb about 441
acres of land. Following construction, LA Storage would maintain about
267 acres for permanent operation of the project's facilities; the
remaining acreage would be restored and revert to former uses. The
Hackberry Pipeline, CIP Lateral, and brine disposal pipeline would be
collocated for 4.7 miles.
    Based on an initial review of LA Storage's proposal and public
comments received during the pre-filing process, Commission staff have
identified several expected impacts that deserve attention in the EIS.
These include: Project impacts on wetlands and other fish and wildlife
resources; impacts on water and air quality; safety of salt domes and
brine injection; greenhouse gas emissions; and climate change.

The NEPA Process and the EIS

    The EIS issued by the Commission will discuss impacts that could
occur as a result of the construction and operation of the proposed
Project under the relevant general resource areas:
     Geology and soils;
     water resources and wetlands;
     vegetation and wildlife;
     threatened and endangered species;
     cultural resources;
     socioeconomics;
     land use;
     greenhouse gas and climate;
     air quality and noise; and
     reliability and safety.
    Commission staff will also make recommendations on how to lessen or
avoid impacts on the various resource areas. Your comments will help
Commission staff focus its analysis on the issues that may have a
significant effect on the human environment.
    The EIS will present Commission staff's independent analysis of the
issues. Staff will prepare a draft EIS which will be issued for public
comment. Commission staff will consider all timely comments received
during the comment period on the draft EIS and revise the document, as
necessary, before issuing a final EIS. Any draft and final EIS will be
available in electronic format in the public record through eLibrary
\2\ and the Commission's natural gas environmental documents web page
(https://www.ferc.gov/industries-data/natural-gas/environment/environmental-documents). If eSubscribed, you will receive instant
email notification when the environmental document is issued.
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    \2\ For instructions on connecting to eLibrary, refer to the
last page of this notice.
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Alternatives Under Consideration

    The EIS will evaluate reasonable alternatives that are technically
and economically feasible and meet the purpose and need for the
proposed action.\3\
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    \3\ 40 CFR 1508.1(z).
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    With this notice, the Commission requests specific comments
regarding any additional potential alternatives to the proposed action
or segments of the proposed action. Please focus your comments on
reasonable alternatives (including alternative facility sites) that
meet the Project objectives, are technically and economically feasible,
and avoid or lessen environmental impact.

Consultation Under Section 106 of the National Historic Preservation
Act

    In accordance with the Advisory Council on Historic Preservation's
implementing regulations for section 106 of the National Historic
Preservation Act, the Commission initiated section 106 consultation for
the Project in the notice issued on October 20, 2020, with the
Louisiana State Historic Preservation Office, and other government
agencies, interested Indian tribes, and the public to solicit their
views and concerns regarding the Project's potential effects on
historic properties.\4\ This notice is a continuation of section 106
consultation for the Project. The Project EIS will document findings on
the impacts on historic properties and summarize the status of
consultations under section 106.
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    \4\ The Advisory Council on Historic Preservation's regulations
are at Title 36, Code of Federal Regulations, part 800. Those
regulations define historic properties as any prehistoric or
historic district, site, building, structure, or object included in
or eligible for inclusion in the National Register of Historic
Places.
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Schedule for Environmental Review

    On February 10, 2021, the Commission issued its Notice of
Application for the Project. Among other things, that notice alerted
other agencies issuing federal authorizations of the requirement to
complete all necessary reviews and to reach a final decision on the
request for a federal authorization within 90 days of the date of
issuance of the Commission staff's final EIS for the Project. This
notice identifies the Commission staff's planned schedule for
completion of a final EIS for the Project, which is based on an
issuance of the draft EIS in December 2021.

Issuance of Notice of Availability of the final EIS: April 8, 2022
90-day Federal Authorization Decision Deadline \5\: July 7, 2022
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    \5\ The Commission's deadline applies to the decisions of other
federal agencies, and state agencies acting under federally
delegated authority, that are responsible for federal
authorizations, permits, and other approvals necessary for proposed
projects under the Natural Gas Act. Per 18 CFR 157.22(a), the
Commission's deadline for other agency's decisions applies unless a
schedule is otherwise established by federal law.

    If a schedule change becomes necessary for the final EIS, an
additional notice will be provided so that the relevant agencies are
kept informed of the Project's progress.

Permits and Authorizations

    The table below lists the anticipated permits and authorizations
for the Project required under federal law. This list may not be all-
inclusive and does not preclude any permit or authorization if it is
not listed here. Agencies with jurisdiction by law and/or special
expertise may formally cooperate in the preparation of the Commission's
EIS and may adopt the EIS to satisfy its NEPA responsibilities related
to this Project. Agencies that would like to request cooperating agency
status should follow the instructions for filing comments provided
under the Public Participation section of this notice.

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                  Permit                               Agency
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Clean Water Act (CWA) Section 404           U.S. Army Corps of
 Discharges to Waters of the United States.  Engineers.

Coastal Use Permit........................  Louisiana Department of
                                             Natural Resources.
Clean Air Act Title V Air Permit..........  Louisiana Department of
                                             Environmental Quality.
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Environmental Mailing List

    This notice is being sent to the Commission's current environmental
mailing list for the Project which includes federal, state, and local
government representatives and agencies; local libraries; newspapers;
elected officials; Native American Tribes; and other interested
parties. This list also includes all affected landowners (as defined in
the Commission's regulations) who are potential right-of-way grantors,
whose property may be used temporarily for Project purposes, or who own
homes within certain distances of aboveground facilities, and anyone
who submits comments on the Project and includes a mailing address with
their comments. Commission staff will update the environmental mailing
list as the analysis proceeds to ensure that Commission notices related
to this environmental review are sent to all individuals,
organizations, and government entities interested in and/or potentially
affected by the proposed Project. State and local government
representatives should notify their constituents of this proposed
Project and encourage them to comment on their areas of concern.
    If you need to make changes to your name/address, or if you would
like to remove your name from the mailing list, please complete one of
the following steps:
    (1) Send an email to<EMAIL_ADDRESS>stating your
request. You must include the docket number CP21-44-000 in your
request. If you are requesting a change to your address, please be sure
to include your name and the correct address. If you are requesting to
delete your address from the mailing list, please include your name and
address as it appeared on this notice. This email address is unable to
accept comments.
    Or
    (2) Return the attached ``Mailing List Update Form'' (appendix 2).

Additional Information

    Additional information about the Project is available from the
Commission's Office of External Affairs, at (866) 208-FERC, or on the
FERC website at www.ferc.gov using the eLibrary link. Click on the
eLibrary link, click on ``General Search'' and enter the docket number
in the ``Docket Number'' field (i.e., CP21-44-000). Be sure you have
selected an appropriate date range. For assistance, please contact FERC
Online Support at<EMAIL_ADDRESS>or<PHONE_NUMBER>, or for
TTY, contact<PHONE_NUMBER>. The eLibrary link also provides access to
the texts of all formal documents issued by the Commission, such as
orders, notices, and rulemakings.
    Public sessions or site visits will be posted on the Commission's
calendar located at https://www.ferc.gov/news-events/events along with
other related information.

    Dated: August 27, 2021.
Kimberly D. Bose,
Secretary.
[FR Doc. 2021-18967 Filed 9-1-21; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 80, Number 247 (Thursday, December 24, 2015)]
[Proposed Rules]
[Pages 80295-80299]
[FR Doc No: 2015-30810]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2014-0651; Directorate Identifier 2014-NM-043-AD]
RIN 2120-AA64

Airworthiness Directives; Gulfstream Aerospace Corporation
Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Supplemental notice of proposed rulemaking (NPRM); reopening of
comment period.

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SUMMARY: We are revising an earlier proposed airworthiness directive
(AD) for all Gulfstream Aerospace Corporation Model GV and GV-SP
airplanes. The NPRM proposed to supersede Airworthiness Directive (AD)
2013-22-19, which requires inspecting to determine if fuel boost pumps
having a certain part number are installed, replacing the fuel boost
pumps having a certain part number, and revising the airplane
maintenance or inspection program to include revised instructions for
continued airworthiness. The NPRM also proposed to require revising the
airplane maintenance program to include a fuel leak check of the fuel
boost pumps, using new service information. The NPRM was prompted by
reports of two independent types of failure of the fuel boost pump:
overheat damage on the internal components and external housing, and
fuel leakage. This action revises the NPRM by reducing the compliance
time for revising the airplane maintenance program. We are proposing
this supplemental NPRM (SNPRM) to prevent fuel leakage in combination
with a capacitor clearance issue, which could result in an uncontrolled
fire in the wheel well. Since these actions impose an additional burden
over that proposed in the NPRM, we are reopening the comment period to
allow the public the chance to comment on these proposed changes.

DATES: We must receive comments on this SNPRM by February 8, 2016.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room

W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.
    For service information identified in this proposed AD, contact
Gulfstream Aerospace Corporation, Technical Publications Dept., P.O.
Box 2206, Savannah, GA 31402-2206; telephone<PHONE_NUMBER>; fax 912-965-
3520; email<EMAIL_ADDRESS>Internet http://www.gulfstream.com/product_support/technical_pubs/pubs/index.htm. You may view this
referenced service information at the FAA, Transport Airplane
Directorate, 1601 Lind Avenue SW., Renton, WA. For information on the
availability of this material at the FAA, call<PHONE_NUMBER>.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2014-
0651; or in person at the Docket Management Facility between 9 a.m. and
5 p.m., Monday through Friday, except Federal holidays. The AD docket
contains this proposed AD, the regulatory evaluation, any comments
received, and other information. The street address for the Docket
Office (phone:<PHONE_NUMBER>) is in the ADDRESSES section. Comments will
be available in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Sanjana Murthy, Aersopace Engineer,
ACE-118A, FAA, Atlanta Aircraft Certification Office, 1701 Columbia
Avenue, College Park, GA 30337; telephone:<PHONE_NUMBER>; fax: 404-474-
5567; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2014-0651;
Directorate Identifier 2014-NM-043-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD because of those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this proposed AD.

Discussion

    We issued an NPRM to amend 14 CFR part 39 to supersede AD 2013-22-
19, Amendment 39-17651 (78 FR 72554, December 3, 2013), which applies
to all Gulfstream Aerospace Corporation Model GV and GV-SP airplanes.
The NPRM published in the Federal Register on October 1, 2014 (79 FR
59162). The NPRM proposed to continue to require inspecting to
determine if fuel boost pumps having a certain part number are
installed, replacing the fuel boost pumps having a certain part number,
and revising the airplane maintenance or inspection program to include
revised instructions for continued airworthiness. The NPRM also
proposed to require revising the airplane maintenance program to
include a fuel leak check of the fuel boost pumps, using new service
information.

Actions Since Previous NPRM (79 FR 59162, October 1, 2014) Was Issued

    Since we issued the NPRM (79 FR 59162, October 1, 2014), we have
determined it is necessary to reduce the compliance time for revising
the airplane maintenance or inspection program in order to address the
identified unsafe condition in a timely manner. Paragraph (i) of the
proposed AD specifies a compliance time of ``within 500 flight hours
after the effective date of this AD'' to accomplish the revision, which
incorporates the fuel leak check inspection of the fuel boost pumps.
The leak check is intended to be performed at 500-hour increments after
the installation of the part number (P/N) 1159SCP500-7 boost pump.
However, operators that have already installed the P/N 1159SCP500-7
boost pump would not be required to perform the leak check until after
the maintenance or inspection program is revised, i.e., within 500
flight hours after the effective date of the AD instead of within 500
flight hours after installation. We have determined a compliance time
of ``within 30 days after the effective date of this AD'' represents an
appropriate interval of time to revise the airplane maintenance or
inspection program. We have revised paragraph (i) of this proposed AD
accordingly.

Comments

    We gave the public the opportunity to participate in developing
this proposed AD. The following presents the comments received on the
NPRM (79 FR 59162, October 1, 2014) and the FAA's response to each
comment.

Request To Use Later Revision of the Service Information

    Gulfstream requested that the FAA reference the upcoming revision
to the airworthiness limitations section of the GV, G500, and G550
maintenance manuals. Gulfstream stated that the maintenance manuals
will include a revised fuel leak check interval of 500 hours 50 hours. Gulfstream stated that drafts of the maintenance
manuals were scheduled to be submitted to the FAA by December 2014,
with FAA approval expected. Gulfstream also stated that the revisions
to the airplane maintenance program include revised instructions for
continued airworthiness to avoid future AD revisions on this subject.
Gulfstream stated that AD 2013-22-19, Amendment 39-17651 (78 FR 72554,
December 3, 2013), references the 05-20-00, Table 20 Fuel Boost Pump
fuel leak check interval of 500 hours, which would prohibit the 50-hour provision that the Gulfstream safety assessment allows,
limiting the flexibility of Gulfstream's operators to perform this fuel
leak check concurrently with other scheduled maintenance.
    We have reviewed the supporting data for this request and we agree
with the request to change the compliance time. We have revised
paragraph (i) of this proposed AD to accommodate this request. In order
to decrease the burden on operators, we are adding 50 hours to the
compliance time, which will enable operators to complete the
requirements of this proposed AD as well as their mandatory inspection
requirement during the same overhaul.
    Operators may request approval to use a later revision of the
referenced service information, when it is approved, as an alternative
method of compliance (AMOC) under the provisions of paragraph (m) of
this proposed AD.

Request To Revise the Compliance Time

    Gulfstream requested that a compliance time specified in paragraph
(i)(2) of the proposed AD (79 FR 59162, October 1, 2014) be revised.
Gulfstream requested that the following language be included in
paragraph (i)(2) of the proposed AD, which is for airplanes on which
the inspection required by paragraph (g) of the proposed AD reveals
that a fuel boost pump with

Gulfstream P/N 1159SCP500-7 has been installed:

    The initial compliance time . . . is within 500 flight hours
after installation of the P/N 11 59SCP500-7 pump, or within 50
flight hours after doing the inspection required by paragraph (g) of
this AD if 500 flight hours have accumulated since installation of
the P/N 1159SCP500-7 pump and an initial leak check of the pump has
not been accomplished.

    We agree to revise the compliance time. The leak check is intended
to be performed at 500-hour increments  50 flight hours
after the installation of the P/N 1159SCP500-7 boost pump. We have
added new paragraph (i)(2)(i) to this proposed AD to specify
compliances times relative to installation of the P/N 1159SCP500-7
pump.

FAA's Determination

    We are proposing this SNPRM because we evaluated all the relevant
information and determined the unsafe condition described previously is
likely to exist or develop in other products of the same type design.
Certain changes described above expand the scope of the proposed AD (79
FR 59162, October 1, 2014). As a result, we have determined that it is
necessary to reopen the comment period to provide additional
opportunity for the public to comment on this SNPRM.

Proposed Requirements of This SNPRM

    This SNPRM would require inspecting to determine if fuel boost
pumps having a certain part number are installed, replacing the fuel
boost pumps having a certain part number, and revising the airplane
maintenance or inspection program to include revised instructions for
continued airworthiness.

Related Service Information Under 1 CFR Part 51

    We have reviewed Gulfstream G500 Customer Bulletin 122, dated April
11, 2012 (for Model GV-SP airplanes designated as G500), which
describes procedures for inspecting and replacing the fuel boost pumps.
    We have also reviewed the following service information, as
applicable, which describes, among other actions, a fuel leak check of
the fuel boost pumps and inspection intervals:
     Table 18, 500 Flight Hours Scheduled Inspection Table, in
Section 05-20-00, of Chapter 5, Time Limits/Maintenance Checks, of the
Gulfstream V Maintenance Manual, Revision 42, dated June 20, 2013;
     Task 28-26-01, Fuel Boost Pumps--Fuel Leak Check, of
Chapter 28, Fuel, of the Gulfstream V Maintenance Manual, Revision 42,
dated June 20, 2013;
     Task 28-26-01, Fuel Boost Pumps--Fuel Leak Checks, in
Table 20, 500 Flight Hours Scheduled Inspection Table, in Section 05-
20-00, of Chapter 5, Time Limits/Maintenance Checks, of the Gulfstream
G500 Maintenance Manual, Revision 23, dated June 20, 2013;
     Task 28-26-01, Fuel Boost Pumps--Fuel Leak Check, of
Section 26, Fuel Boost Pumps, of Chapter 28, Fuel, of the Gulfstream
G550 Maintenance Manual, Revision 23, dated June 20, 2013;
     Task 28-26-01, Fuel Boost Pumps--Fuel Leak Check, in Table
20, 500 Flight Hours Scheduled Inspection Table, in Section 05-20-00,
of Chapter 5, Time Limits/Maintenance Checks, of the Gulfstream G550
Maintenance Manual, Revision 23, dated June 20, 2013; and
     Task 28-26-01, Fuel Boost Pumps--Fuel Leak Check, of
Section 26, Fuel Boost Pumps, of Chapter 28, Fuel, of the Gulfstream
G550 Maintenance Manual, Revision 23, dated June 20, 2013.
    This service information is reasonably available because the
interested parties have access to it through their normal course of
business or by the means identified in the ADDRESSES section.

Costs of Compliance

    We estimate that this proposed AD would affect 357 airplanes of
U.S. registry.
    We estimate the following costs to comply with this proposed AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost on
                    Action                                Labor cost               Parts     Cost per     U.S.
                                                                                cost     product   operators
----------------------------------------------------------------------------------------------------------------
Inspection to determine if a certain part      1 work-hour x $85 per hour = $85         $0        $85    $30,345
 number is installed [retained actions from
 AD 2013-22-19, Amendment 39-17651 (78 FR
 72554, December 3, 2013)].
Maintenance program revision [new proposed     1 work-hour x $85 per hour = $85          0         85     30,345
 action].
----------------------------------------------------------------------------------------------------------------

    We estimate the following costs to do any necessary replacements
that would be required based on the results of the inspection. We have
no way of determining the number of aircraft that might need these
replacements:

                            On-Condition Cost
------------------------------------------------------------------------
                                                               Cost per
            Action                 Labor cost     Parts cost    product
------------------------------------------------------------------------
Replacement...................  24 work-hours x      $7,600      $9,640
                                 $85 per hour =
                                 $2,040.
------------------------------------------------------------------------

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 proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would 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 proposed
regulation:
    (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),
    (3) Will not affect intrastate aviation in Alaska, and
    (4) 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.

List of Subjects in 14 CFR Part 39

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

The Proposed Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA proposes to amend 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 removing Airworthiness Directive (AD)
2013-22-19, Amendment 39-17651 (78 FR 72554, December 3, 2013), and
adding the following new AD:

Gulfstream Aerospace Corporation: FAA-2014-0651; Directorate
Identifier 2014-NM-043-AD.

(a) Comments Due Date

    We must receive comments by February 8, 2016.

(b) Affected ADs

    This AD replaces AD 2013-22-19, Amendment 39-17651 (78 FR 72554,
December 3, 2013).

(c) Applicability

    This AD applies to all Gulfstream Aerospace Corporation Model GV
and GV-SP airplanes, certificated in any category.

(d) Subject

    Air Transport Association (ATA) of America Code 28, Fuel.

(e) Unsafe Condition

    This AD was prompted by reports of two independent types of
failure of the fuel boost pump: overheat damage on the internal
components and external housing, and fuel leakage. We are issuing
this AD to prevent fuel leakage in combination with a capacitor
clearance issue, which could result in an uncontrolled fire in the
wheel well.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Retained Inspection To Determine the Part Number, With Revised
Service Information

    This paragraph restates the actions required by paragraph (g) of
AD 2013-22-19, Amendment 39-17651 (78 FR 72554, December 3, 2013),
with revised service information. Within 36 months after January 7,
2014 (the effective date of AD 2013-22-19), inspect the fuel boost
pumps to determine whether Gulfstream part number (P/N) 1159SCP500-5
is installed, in accordance with the Accomplishment Instructions of
the applicable service information identified in paragraphs (g)(1),
(g)(2), and (g)(3) of this AD; including Triumph Aerostructures
Service Bulletin SB-TAGV/GVSP-28-JG0162, dated August 30, 2011; and
GE Service Bulletin 31760-28-100, dated February 15, 2011. A review
of airplane maintenance records is acceptable in lieu of this
inspection if the part number of the fuel boost pumps can be
conclusively determined from that review.
    (1) For Model GV airplanes: Gulfstream V Customer Bulletin 197,
dated April 11, 2012.
    (2) For Model GV-SP airplanes designated as G500: Gulfstream
G500 Customer Bulletin 122, dated April 11, 2012; or Gulfstream G550
Customer Bulletin 122, dated April 11, 2012.
    (3) For Model GV-SP airplanes designated as G550: Gulfstream
G550 Customer Bulletin 122, dated April 11, 2012.

(h) Retained Replacement With Revised Service Information

    This paragraph restates the actions required by paragraph (h) of
AD 2013-22-19, Amendment 39-17651 (78 FR 72554, December 3, 2013),
with revised service information. If the inspection required by
paragraph (g) of this AD reveals a fuel boost pump with Gulfstream
P/N 1159SCP500-5: Within 36 months after January 7, 2014 (the
effective date of AD 2013-22-19), replace the fuel boost pump with a
serviceable pump having Gulfstream P/N 1159SCP500-7, in accordance
with the applicable service information identified in paragraphs
(h)(1), (h)(2), and (h)(3) of this AD; including Triumph
Aerostructures Service Bulletin SB-TAGV/GVSP-28-JG0162, dated August
30, 2011; and GE Service Bulletin 31760-28-100, dated February 15,
2011.
    (1) For Model GV airplanes: Gulfstream V Customer Bulletin 197,
dated April 11, 2012.
    (2) For Model GV-SP airplanes designated as G500: Gulfstream
G500 Customer Bulletin 122, dated April 11, 2012; or Gulfstream G550
Customer Bulletin 122, dated April 11, 2012.
    (3) For Model GV-SP airplanes designated as G550: Gulfstream
G550 Customer Bulletin 122, dated April 11, 2012.

(i) New Revision of the Maintenance or Inspection Program

    Within 30 days after the effective date of this AD, revise the
airplane maintenance or inspection program, as applicable, to
include the fuel leak check inspection of the fuel boost pumps
specified in the applicable task identified in paragraph (j) of this
AD.
    (1) For airplanes on which fuel boost pump Gulfstream P/N
1159SCP500-5 has been replaced in accordance with paragraph (h) of
this AD: The initial compliance time for the leak check inspection
specified in the applicable task identified in paragraph (j) of this
AD is within 550 flight hours after doing the replacement specified
in paragraph (h) of this AD, or within 30 days after the effective
date of this AD, whichever occurs later.
    (2) For airplanes on which the inspection required by paragraph
(g) of this AD reveals that a fuel boost pump with Gulfstream P/N
1159SCP500-7 has been installed: The initial compliance time for the
leak check inspection specified in the applicable task identified in
paragraph (j) of this AD, is at the later of the times specified in
paragraphs (i)(2)(i) and (i)(2)(ii) of this AD.
    (i) Within 550 flight hours after the installation of the P/N
1159SCP500-7 pump; except if 550 flight hours have accumulated since
installation of the P/N 1159SCP500-7 pump and an initial leak check
of the pump has not been accomplished, the compliance time is within
50 flight hours after doing the inspection required by paragraph (g)
of this AD.
    (ii) Within 30 days after the effective date of this AD.

(j) Service Information for Maintenance Program Revision

    Use the applicable service information specified in paragraph
(j)(1), (j)(2), or (j)(3) of this AD to revise the airplane
maintenance or inspection program, as applicable, as required by
paragraph (i) of this AD.
    (1) For Model GV airplanes: Use table 18, ``500 Flight Hours
Scheduled Inspection Table,'' in section 05-20-00, of chapter 5, Time
Limits/Maintenance Checks; and task 28-26-01, Fuel Boost Pumps--Fuel
Leak Check, of chapter 28, Fuel; of the Gulfstream V Maintenance
Manual, Revision 42, dated June 20, 2013.
    (2) For Model GV-SP airplanes designated as G500: Use task 28-26-
01, Fuel Boost Pumps--Fuel Leak Checks, in table 20, ``500 Flight Hours
Scheduled Inspection Table,'' in section 05-20-00, of chapter 5, Time
Limits/Maintenance Checks; and task 28-26-01, Fuel Boost Pumps--Fuel
Leak Check, of section 26, Fuel Boost Pumps, of chapter 28, Fuel; of
the Gulfstream

G500 Maintenance Manual, Revision 23, dated June 20, 2013.
    (3) For Model GV-SP airplanes designated as G550: Use task 28-26-
01, Fuel Boost Pumps--Fuel Leak Check, in table 20, ``500 Flight Hours
Scheduled Inspection Table,'' in section 05-20-00, of chapter 5, Time
Limits/Maintenance Checks; and task 28-26-01, Fuel Boost Pumps--Fuel
Leak Check, of section 26, Fuel Boost Pumps, of chapter 28, Fuel; of
the Gulfstream G550 Maintenance Manual, Revision 23, dated June 20,
2013.

(k) No Alternative Actions or Intervals

    After accomplishing the revision required by paragraph (i) of this
AD, no alternative actions (e.g., inspections) or intervals may be used
unless the actions or intervals are approved as an alternative method
of compliance in accordance with the procedures specified in paragraph
(m) of this AD.

(l) Parts Installation Prohibition

    As of January 7, 2014 (the effective date of AD 2013-22-19,
Amendment 39-17651 (78 FR 72554, December 3, 2013)), no person may
install a fuel boost pump having Gulfstream P/N 1159SCP500-5 on any
airplane.

(m) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Atlanta Aircraft Certification Office (ACO), 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
manager of the ACO, send it to the attention of the person identified
in paragraph (n)(1) of this AD.
    (2) 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.
    (3) AMOCs approved for AD 2013-22-19, Amendment 39-17651 (78 FR
72554, December 3, 2013), are approved as AMOCs for the corresponding
provisions of this AD.
    (4) For service information that contains steps that are labeled as
Required for Compliance (RC), the provisions of paragraphs (m)(4)(i)
and (m)(4)(ii) apply.
    (i) The steps labeled as RC, including substeps under an RC step
and any figures identified in an RC step, must be done to comply with
the AD. An AMOC is required for any deviations to RC steps, including
substeps and identified figures.
    (ii) Steps not labeled as RC may be deviated from using accepted
methods in accordance with the operator's maintenance or inspection
program without obtaining approval of an AMOC, provided the RC steps,
including substeps and identified figures, can still be done as
specified, and the airplane can be put back in an airworthy condition.

(n) Related Information

    (1) For more information about this AD, contact Sanjana Murthy,
Aersopace Engineer, ACE-118A, FAA, Atlanta Aircraft Certification
Office, 1701 Columbia Avenue, College Park, GA 30337; telephone: 404-
474-5573; fax:<PHONE_NUMBER>; email<EMAIL_ADDRESS>    (2) For service information identified in this AD, contact
Gulfstream Aerospace Corporation, Technical Publications Dept., P.O.
Box 2206, Savannah, GA 31402-2206; telephone<PHONE_NUMBER>; fax 912 965-
3520; email<EMAIL_ADDRESS>Internet http://www.gulfstream.com/product_support/technical_pubs/pubs/index.htm. You may view this
referenced service information at the FAA, Transport Airplane
Directorate, 1601 Lind Avenue SW., Renton, WA. For information on the
availability of this material at the FAA, call<PHONE_NUMBER>.

    Issued in Renton, Washington, on November 24, 2015.
Jeffrey E. Duven,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2015-30810 Filed 12-23-15; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 79, Number 126 (Tuesday, July 1, 2014)]
[Notices]
[Page 37311]
[FR Doc No: 2014-15464]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OAR-2007-1138; FRL-9913-09-OAR]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Reporting and Recordkeeping Requirements for
Importation of Nonroad Engines and Recreational Vehicles

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: In compliance with the Paperwork Reduction Act (PRA) (44
U.S.C. 3501 et seq.), this document announces that the Environmental
Protection Agency (EPA) is planning to submit a request to renew an
existing approved Information Collection Request (ICR) to the Office of
Management and Budget (OMB). This ICR is scheduled to expire on
December 31, 2014. Before submitting the ICR to OMB for review and
approval, EPA is soliciting comments on specific aspects of the
proposed information collection as described below.

DATES: Comments must be submitted on or before September 2, 2014.

ADDRESSES: Submit your comments referencing Docket ID No. EPA-HQ-OAR-
2007-1138 online using www.regulations.gov (our preferred method), by
email to<EMAIL_ADDRESS>or by mail to: EPA Docket Center,
Environmental Protection Agency, Mailcode 28221T, 1200 Pennsylvania
Ave. NW., Washington, DC 20460.
    EPA's policy is that all comments received will be included in the
public docket without change including any personal information
provided, unless the comment includes profanity, threats, information
claimed to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute.

FOR FURTHER INFORMATION CONTACT: Holly Pugliese, Compliance Division,
Office of Transportation and Air Quality, Environmental Protection
Agency, 2000 Traverwood, Ann Arbor, Michigan, 48105; telephone number:
734-214-4288; fax number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:
    Supporting documents which explain in detail the information that
the EPA will be collecting are available in the public docket for this
ICR. The docket can be viewed online at www.regulations.gov or in
person at the EPA Docket Center, WJC West, Room 3334, 1301 Constitution
Ave. NW., Washington, DC. The telephone number for the Docket Center is
202-566-1744. For additional information about EPA's public docket,
visit http://www.epa.gov/dockets.
    Pursuant to section 3506(c)(2)(A) of the PRA, EPA is soliciting
comments and information to enable it to: (i) Evaluate whether the
proposed collection of information is necessary for the proper
performance of the functions of the Agency, including whether the
information will have practical utility; (ii) evaluate the accuracy of
the Agency's estimate of the burden of the proposed collection of
information, including the validity of the methodology and assumptions
used; (iii) enhance the quality, utility, and clarity of the
information to be collected; and (iv) minimize the burden of the
collection of information on those who are to respond, including
through the use of appropriate automated electronic, mechanical, or
other technological collection techniques or other forms of information
technology, e.g., permitting electronic submission of responses. EPA
will consider the comments received and amend the ICR as appropriate.
The final ICR package will then be submitted to OMB for review and
approval. At that time, EPA will issue another Federal Register notice
to announce the submission of the ICR to OMB and the opportunity to
submit additional comments to OMB.
    Abstract: This ICR covers the burden associated with EPA Form 3520-
21, a declaration form for importers of nonroad vehicles or engines
into the United States, which identifies the regulated category of
engine or vehicle and the regulatory provisions under which the
importation is taking place. In addition, this ICR covers the possible
burden of EPA Form 3520-8 if it comes to be used to request final
importation clearance for Independent Commercial Importers of nonroad
Compression Ignition engines, who would have to bring the engines into
compliance and provide test results, comparable to the use of Form
3520-8 for on-road vehicles and engines as covered by OMB 2060-0095.
The information is used by Agency enforcement personnel to verify that
all nonroad vehicles and engines subject to Federal emission
requirements have been declared upon entry or that the category of
exclusion or exemption from emissions requirements has been identified
in the declaration. The information is also used to identify and
prosecute violators of the regulations and to monitor the program in
achieving the objectives of the regulations. The Forms are required
before making customs entry; see 19 CFR 12.73 and 12.74.
    Form Number: 3520-21.
    Frequency of response: Once per entry. (One form per shipment may
be used.)
    Respondents/affected entities: Information collected is from
individual importers, or companies who import and manufacture nonroad
engines and recreational vehicles.
    Respondent's obligation to respond: Required for any importer to
legally import nonroad vehicles or engines into the U.S.
    Estimated number of respondents: 12,000.
    Total estimated burden: 6029 hours (per year). Burden is defined at
5 CFR 1320.03(b).
    Total estimated cost: $410,178.38 (per year), includes $38,002
annualized capital or operation & maintenance costs.
    Changes in Estimates: This is an increase in $110,896.39 the total
estimated respondent burden compared with the ICR currently approved by
OMB. The program has remained consistent over time and the increase in
burden is primarily due to costs of labor.

    Dated: June 19, 2014.
Byron J. Bunker,
Director, Compliance Division, Office of Transportation and Air
Quality.
[FR Doc. 2014-15464 Filed 6-30-14; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 88, Number 235 (Friday, December 8, 2023)]
[Notices]
[Pages 85643-85645]
[FR Doc No: 2023-26989]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-E-5267]

Determination of Regulatory Review Period for Purposes of Patent
Extension; Nuzyra Tablets (New Drug Application 209816)

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) has
determined the regulatory review period for Nuzyra Tablets (new drug
application (NDA) 209816) and is publishing this notice of that
determination as required by law. FDA has made the determination
because of the submission of an application to the Director of the U.S.
Patent and Trademark Office (USPTO), Department of Commerce, for the
extension of a patent which claims that human drug product.

DATES: Anyone with knowledge that any of the dates as published (see
SUPPLEMENTARY INFORMATION) are incorrect must submit either electronic
or written comments and ask for a redetermination by February 6, 2024.
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 June 5, 2024. 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. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of February 6, 2024. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are received 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-2019-E-5267 for ``Determination of Regulatory Review Period for
Purposes of Patent Extension; NUZYRA TABLETS (NDA 209816).'' Received
comments, those filed in a timely manner (see ADDRESSES), will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in

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

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

SUPPLEMENTARY INFORMATION:

I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984
(Pub. L. 98-417) and the Generic Animal Drug and Patent Term
Restoration Act (Pub. L. 100-670) generally provide that a patent may
be extended for a period of up to 5 years so long as the patented item
(human drug or biological product, animal drug product, medical device,
food additive, or color additive) was subject to regulatory review by
FDA before the item was marketed. Under these acts, a product's
regulatory review period forms the basis for determining the amount of
extension an applicant may receive.
    A regulatory review period consists of two periods of time: a
testing phase and an approval phase. For human drug products, the
testing phase begins when the exemption to permit the clinical
investigations of the drug becomes effective and runs until the
approval phase begins. The approval phase starts with the initial
submission of an application to market the human drug product and
continues until FDA grants permission to market the drug product.
Although only a portion of a regulatory review period may count toward
the actual amount of extension that the Director of USPTO may award
(for example, half the testing phase must be subtracted as well as any
time that may have occurred before the patent was issued), FDA's
determination of the length of a regulatory review period for a human
drug product will include all of the testing phase and approval phase
as specified in 35 U.S.C. 156(g)(1)(B).
    FDA has approved for marketing the human drug product Nuzyra
Tablets (NDA 209816) (omadacycline). Nuzyra Tablets (NDA 209816) is
indicated for the treatment of adult patients with the following
infections caused by susceptible microorganisms:
     Community-acquired bacterial pneumonia, and
     Acute bacterial skin and skin structure infections.
    Subsequent to this approval, the USPTO received a patent term
restoration application for Nuzyra Tablets (NDA 209816) (U.S. Patent
No. 9,265,740) from Paratek Pharmaceuticals, Inc., and the USPTO
requested FDA's assistance in determining the patent's eligibility for
patent term restoration. In a letter dated December 23, 2019, FDA
advised the USPTO that this human drug product had undergone a
regulatory review period and that the approval of Nuzyra Tablets (NDA
209816) and Nuzyra Injection (NDA 209817) represented the first
permitted commercial marketing or use of the product. Thereafter, the
USPTO requested that FDA determine the products' regulatory review
period.

II. Determination of Regulatory Review Period

    FDA has determined that the applicable regulatory review period for
Nuzyra Tablets (NDA 209816) is 4,361 days. Of this time, 4,118 days
occurred during the testing phase of the regulatory review period,
while 243 days occurred during the approval phase. These periods of
time were derived from the following dates:
    1. The date an exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(i)) became effective:
October 26, 2006. The applicant claims September 26, 2006, as the date
the investigational new drug application (IND) became effective.
However, FDA records indicate that the IND effective date was October
26, 2006, which was 30 days after FDA receipt of the IND.
    2. The date the application was initially submitted with respect to
the human drug product under section 505 of the FD&C Act: February 2,
2018. FDA has verified the applicant's claim that the NDA for Nuzyra
Tablets (NDA 209816) was initially submitted on February 2, 2018.
    3. The date the application was approved: October 2, 2018. FDA has
verified the applicant's claim that NDA 209816 was approved on October
2, 2018.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the USPTO
applies several statutory limitations in its calculations of the actual
period for patent extension. In its application for patent extension,
this applicant seeks 597 days of patent term extension.

    Note:  We have determined that the regulatory review period for
the human drug product, Nuzyra, approved under NDA 209816 is the
same as the regulatory review period determined for the human drug
product, Nuzyra, approved under NDA 209817.

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: December 1, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-26989 Filed 12-7-23; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: August 12, 2010 (Volume 75, Number 155)]
[Notices]
[Page 48965-48966]
[DOCID:fr12au10-50]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RM98-1-000]

Records Governing Off-the Record Communications; Public Notice

August 5, 2010.
    This constitutes notice, in accordance with 18 CFR 385.2201(b), of
the receipt of prohibited and exempt off-the-record communications.
    Order No. 607 (64 FR 51222, September 22, 1999) requires Commission
decisional employees, who make or receive a prohibited or exempt off-
the-record communication relevant to the merits of a contested
proceeding, to deliver to the Secretary of the Commission, a copy of
the communication, if written, or a summary of the substance of any
oral communication.
    Prohibited communications are included in a public, non-decisional
file associated with, but not a part of, the decisional record of the
proceeding. Unless the Commission determines that the prohibited
communication and any responses thereto should become a part of the
decisional record, the prohibited off-the-record communication will not
be considered by the Commission in reaching its decision. Parties to a
proceeding may seek the opportunity to respond to any facts or
contentions made in a prohibited off-the-record communication, and may
request that the Commission place the prohibited communication and
responses thereto in the decisional record. The Commission will grant
such a request only when it determines that fairness so requires. Any
person identified below as having made a prohibited off-the-record
communication shall serve the document on all parties listed on the
official service list for the applicable proceeding in accordance with
Rule 2010, 18 CFR 385.2010.
    Exempt off-the-record communications are included in the decisional
record of the proceeding, unless the communication was with a
cooperating agency as described by 40 CFR 1501.6, made under 18 CFR
385.2201(e)(1)(v).
    The following is a list of off-the-record communications recently
received by the Secretary of the Commission. The communications listed
are grouped by docket numbers in ascending order. These filings are
available for review at the Commission in the Public Reference Room or
may be viewed on the Commission's Web site at http://www.ferc.gov using
the eLibrary

link. Enter the docket number, excluding the last three digits, in the
docket number field to access the document. For assistance, please
contact FERC, Online Support at<EMAIL_ADDRESS>or toll free
at<PHONE_NUMBER>, or for TTY, contact<PHONE_NUMBER>.
    Exempt:

----------------------------------------------------------------------------------------------------------------
                 Docket No.                       File date                   Presenter or requester
----------------------------------------------------------------------------------------------------------------
1. P-2106-000..............................              8-3-10  Steve Nevares
2. P-12775-000.............................              8-3-10  Michael Hilton, PhD
----------------------------------------------------------------------------------------------------------------

Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2010-19850 Filed 8-11-10; 8:45 am]
BILLING CODE 6717-01-P