[Federal Register Volume 86, Number 187 (Thursday, September 30, 2021)]
[Notices]
[Pages 54182-54185]
[FR Doc No: 2021-21268]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket Nos. CP19-502-000; CP19-502-001]

Commonwealth LNG, LLC; Notice of Intent To Prepare an
Environmental Impact Statement for the Proposed Commonwealth LNG
Project, Request for Comments on Environmental Issues, and Revised
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 Commonwealth LNG Project
(Project) involving construction and operation of facilities by
Commonwealth LNG, LLC (Commonwealth LNG) in Cameron Parish, Louisiana.
The Commission will use this EIS in its decision-making process to
determine whether the 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 an authorization. This gathering
of public input is referred to as ``scoping.'' By notice issued on
February 22, 2018, in Docket No. PF17-8, the Commission opened a
scoping period during the pre-filing review process for the Project;
and staff intends to prepare an EIS that will address the concerns
raised during that previous scoping period as well as comments received
in response to this notice based on Commonwealth LNG's Project
application filing, as supplemented, in Docket No. CP19-502. 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 October 25, 2021.
Further details on how to submit comments are provided in the Public
Participation section of this notice.
    As mentioned above, the Commission previously opened a scoping
period which expired on March 26, 2018. All substantive written and
oral comments provided during the previous scoping period will be
addressed in the EIS. Therefore, if you submitted comments on this
Project to the Commission during the previous scoping period, you do
not need to file those comments again.
    Commonwealth LNG 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 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 also 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 numbers (CP19-
502-000; CP19-502-001) 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

    Commonwealth LNG proposes to construct and operate a new liquefied
natural gas (LNG) export terminal and accompanying natural gas pipeline
on the west side of the Calcasieu Ship Channel at its entrance to the
Gulf of Mexico. The LNG export terminal would consist of six natural
gas liquefaction trains (with nominal liquefaction and production
capacities of 1.4 million metric tonnes per annum each), six LNG
storage tanks (with storage capacities of 50,000 cubic meters each),
and one marine berth capable of accommodating LNG carriers with
capacities up to 216,000 cubic meters. Commonwealth LNG would construct
a

42-inch-diameter natural gas pipeline from the LNG export terminal,
extending 3.0 miles north to interconnect with existing natural gas
pipelines within Cameron Parish. The proposed Project would require
about 182 acres to construct and would occupy about 107 acres during
operation.
    Commonwealth states that the purpose of the proposed Project is to
liquefy and export to foreign markets, domestically produced natural
gas sourced from the existing interstate and intrastate pipeline
systems of Kinetica Partners, LLC and EnLink Bridgeline Holdings LP,
respectively, in southwest Louisiana.
    The general location of the Project 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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    Based on the previous pre-filing review and a review of
Commonwealth LNG's filed proposal, Commission staff have identified a
few expected impacts that deserve attention in the EIS. These include
wetland impacts, associated threatened and endangered species impacts,
and increased greenhouse gas emissions.

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;
     land use;
     socioeconomics and environmental justice;
     air quality and noise;
     public safety; and
     cumulative impacts.
    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. Alternatives currently under consideration include:
     The no-action alternative, meaning the Project is not
implemented;
     use of other existing and proposed LNG terminals to
provide the liquefaction capabilities proposed by Commonwealth LNG; and
     alternative locations to construct the Project.
    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 and
pipeline routes) that meet the Project purpose, 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 February 22, 2018, with the
applicable State Historic Preservation Officer, 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.\3\ This current 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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    \3\ The Advisory Council on Historic Preservation's regulations
are at Title 36, Code of Federal Regulations, Part 800. Those
regulations define historic properties as any prehistoric or
historic district, site, building, structure, or object included in
or eligible for inclusion in the National Register of Historic
Places.
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Schedule for Environmental Review

    On September 3, 2019, 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. On
October 15, 2019, the Commission issued a notice of schedule for
environmental review of the Project, which identified October 2, 2020
as the final EIS issuance date. However, the Commission suspended the
environmental review schedule for the Project on March 16, 2020,
pending adequate responses from Commonwealth LNG to Commission staff
data requests and an official interpretation from the U.S. Department
of Transportation's Pipeline and Hazardous Material Safety
Administration (PHMSA) pertaining to Commonwealth LNG's proposed LNG
storage tank design. On June 8, 2021, Commonwealth LNG filed a limited
amendment to its Natural Gas Act Section 3 Application to modify the
proposed LNG storage tank designs and capacities so as not to require
an interpretation from PHMSA. Commonwealth LNG has filed the majority
of responses to the Commission staff's data requests to-date and have
stated that all outstanding responses will be filed in 2021. As a
result, Commission staff have revised the schedule for issuance of the
final EIS, based on an issuance of the draft EIS in March 2022.

Issuance of Notice of Availability of the final EIS: September 9, 2022
90-day Federal Authorization Decision Deadline: December 8, 2022

    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 their 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.

     Environmental Permits, Approvals, Clearances, and Consultations
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                                               Permit, approval, or
                 Agency                            consultation
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Federal:
    Federal Energy Regulatory            Natural Gas Act Section 3.
     Commission.
    U.S. Department of Energy/Office of  Natural Gas Act Section 3,
     Fossil Energy.                       Amendment of Free Trade
                                          Agreement Authorization and
                                          Non-Free Trade Agreement
                                          Authorization.
    U.S. Army Corps of Engineers.......  Clean Water Act Section 404/
                                          Rivers & Harbors Act Section
                                          10.
                                         Section 408 (Section 14 Rivers
                                          & Harbors Act).
    U.S. Army Corps of Engineers.......  Programmatic General Permit--
                                          Category 1 for Geotechnical
                                          Investigation.
    U.S. Coast Guard...................  Letter of Intent and
                                          Preliminary Waterway
                                          Suitability Assessment.
                                         Follow-on Waterway Suitability
                                          Assessment
                                         Letter of Recommendation.
    U.S. Fish & Wildlife Service.......  Section 7 of the Endangered
                                          Species Act.
                                         Migratory Bird Treaty Act.
                                         Bald and Golden Eagle
                                          Protection Act.
    National Marine Fisheries Service,   Section 7 of the Endangered
     Protected Resources Division.        Species Act.
    National Marine Fisheries Service,   Magnuson-Stevens Fishery
     Habitat Conservation Division.       Management and Conservation
                                          Act Essential Fish Habitat
                                          Consultation.
    National Marine Fisheries Service,   Marine Mammal Protection Act.
     Office of Protected Resources.
    Federal Aviation Administration....  Notice of Proposed
                                          Construction.
    Federal Emergency Management Agency  Permit for floodplain
                                          development.
    U.S. Department of Transportation..  Pre-construction Notice.
State of Louisiana:
    Louisiana Department of Natural      Coastal Use Permit Coastal Zone
     Resources, Office of Coastal         Management Act Consistency
     Management.                          Determination.
    Louisiana Department of              Air Emissions Permit (Title V
     Environmental Quality--Air Quality   and Prevention of Significant
     Division.                            Deterioration).
    Louisiana Department of              Section 401 Clean Water Act
     Environmental Quality--Water         Water Quality Certification.
     Quality Division.
                                         Louisiana Pollutant Discharge
                                          Elimination System General
                                          Permit LAG670000--Hydrostatic
                                          Test and Vessel Testing
                                          Wastewater.
                                         Louisiana Pollutant Discharge
                                          Elimination System General
                                          Permit LAR050000--Multi-Sector
                                          General Stormwater Permit.
    Louisiana Department of Wildlife     Threatened and Endangered
     and Fisheries.                       Species Consultation.
                                         License to Dredge.
                                         Oyster lease consultation.
    Louisiana Department of Culture      Section 106 National Historic
     Recreation and Tourism/State         Preservation Act Consultation.
     Historic Preservation Officer.
    Louisiana Department of              Review of road easements,
     Transportation and Development.      modifications to state
                                          highways, traffic safety.
    Louisiana Office of State Lands....  State Water Bottom Lease.
Cameron Parish:
    Cameron Parish Police Jury.........  Development Permit.
                                         Coastal Use Letter of No
                                          Objection.
    Coastal Protection and Restoration   Letter of No Impact.
     Authority.
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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; elected officials;
environmental and public interest groups; federally recognized Indian
tribes; other interested parties; and local libraries and newspapers.
This list also includes all affected landowners (as defined in the
Commission's regulations) 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 CP19-502-000 or 001 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., CP19-502). 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: September 24, 2021.
Kimberly D. Bose,
Secretary.
[FR Doc. 2021-21268 Filed 9-29-21; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 81, Number 211 (Tuesday, November 1, 2016)]
[Proposed Rules]
[Pages 75762-75764]
[FR Doc No: 2016-26334]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2012-1327; Directorate Identifier 2012-NE-47-AD]
RIN 2120-AA64

Airworthiness Directives; Rolls-Royce plc Turbofan Engines

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: We propose to supersede airworthiness directive (AD) 2014-16-

10 that applies to all Rolls-Royce plc (RR) RB211 Trent 768-60, 772-60,
and 772B-60 turbofan engines. AD 2014-16-10 requires initial and
repetitive ultrasonic inspections (UIs) of the affected low-pressure
(LP) compressor blades. Since we issued AD 2014-16-10, RR issued
revised service information to reduce the inspection threshold. This
proposed AD would retain the UIs in AD 2014-16-10 while applying the
revised inspection threshold. We are proposing this AD to prevent LP
compressor blade airfoil separations, damage to the engine, and damage
to the airplane.

DATES: We must receive comments on this proposed AD by December 16,
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: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    For service information identified in this NPRM, contact Rolls-
Royce plc, P.O. Box 31, Derby DE24 8BJ, UK; phone: 44 0 1332 242424;
fax: 44 0 1332 249936. You may view this service information at the
FAA, Engine & Propeller Directorate, 1200 District Avenue, Burlington,
MA. 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-2012-
1327; 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 mandatory continuing airworthiness
information, regulatory evaluation, any comments received, and other
information. The 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: Robert Green, Aerospace Engineer,
Engine Certification Office, FAA, Engine & Propeller Directorate, 1200
District Avenue, Burlington, MA 01803; phone:<PHONE_NUMBER>; fax: 781-
238-7199; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this NPRM. Send your comments to an address listed
under the ADDRESSES section. Include ``Docket No. FAA-2012-1327;
Directorate Identifier 2012-NE-47-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this NPRM. We will
consider all comments received by the closing date and may amend this
NPRM 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 NPRM.

Discussion

    On August 1, 2014, we issued AD 2014-16-10, Amendment 39-17934 (79
FR 48961, August 19, 2014), (``AD 2014-16-10'') for all RR RB211 Trent
768-60, 772-60, and 772B-60 turbofan engines. AD 2014-16-10 requires
initial and repetitive UIs of the affected LP compressor blades. AD
2014-16-10 resulted from LP compressor blade partial airfoil blade
release events. We issued AD 2014-16-10 to prevent LP compressor blade
airfoil separations, damage to the engine, and damage to the airplane.

Actions Since AD 2014-16-10 Was Issued

    Since we issued AD 2014-16-10, RR issued Alert Non-Modification
Service Bulletin (NMSB) RB.211-72-AH465, Revision 2, dated May 11,
2016. The Alert NMSB reduced the inspection threshold for UI of the LP
compressor blades. Also since we issued AD 2014-16-10, the European
Aviation Safety Agency (EASA) issued a correction to AD 2016-0141,
dated July 20, 2016, requiring the revised inspection threshold.

Related Service Information Under 1 CFR Part 51

    RR has issued Alert NMSB RB.211-72-AH465, Revision 2, dated May 11,
2016. The NMSB describes procedures for performing a UI of the LP
compressor blades. 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.

FAA's Determination

    We are proposing this AD 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.

Proposed AD Requirements

    This proposed AD would require initial and repetitive UIs of the
affected LP compressor blades. This proposed AD would require
conducting the UIs at a reduced inspection threshold.

Costs of Compliance

    We estimate that this proposed AD affects 56 engines installed on
airplanes of U.S. registry. We also estimate that it would take about
40 hours per engine to comply with this proposed AD. The average labor
rate is $85 per hour. Based on these figures, we estimate the cost of
this proposed AD on U.S. operators to be $190,400.

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 have 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 that the 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 to the extent
that it justifies making a regulatory distinction, 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)
2014-16-10, Amendment 39-17934 (79 FR 48961, August 19, 2014), and
adding the following new AD:

Rolls-Royce plc: Docket No. FAA-2012-1327; Directorate Identifier
2012-NE-47-AD.

(a) Comments Due Date

    We must receive comments by December 16, 2016.

(b) Affected ADs

    This AD supersedes AD 2014-16-10, Amendment 39-17934 (79 FR
48961, August 19, 2014).

(c) Applicability

    This AD applies to Rolls-Royce plc (RR) RB211 Trent 768-60, 772-
60, and 772B-60 turbofan engines, with low-pressure (LP) compressor
blade, part number (P/N) FK23411, FK25441, FK25968, FW11901,
FW15393, FW23643, FW23741, FW23744, KH23403, or KH23404, installed.

(d) Unsafe Condition

    This AD was prompted by LP compressor blade partial airfoil
release events. We are issuing this AD to prevent LP compressor
blade airfoil separations, damage to the engine, and damage to the
airplane.

(e) Compliance

    Comply with this AD within the compliance times specified,
unless already done.
    (1) Ultrasonic Inspection (UI) of LP Compressor Blade
    (i) After the effective date of this AD, for LP compressor
blades that have accumulated less than 1,800 cycles since new (CSN)
or cycles since last inspection (CSLI), perform a UI of each LP
compressor blade before the blade exceeds 2,400 CSN or CSLI. Repeat
the UI of the blade before exceeding 2,400 CSLI.
    (ii) For any LP compressor blade that exceeds 1,800 CSN on the
effective date of this AD, inspect the blade before exceeding 600
flight cycles after the effective date of this AD or before
exceeding 3,600 CSN, whichever occurs first. Thereafter, perform the
repetitive inspections before exceeding 2,400 CSLI.
    (iii) For any blade that exceeds 2,200 CSLI on September 23,
2014 (the effective date of AD 2014-16-10), inspect the blade before
exceeding 3,000 CSLI or before further flight, whichever occurs
later. Thereafter, perform the repetitive inspections before
exceeding 2,400 CSLI.
    (iv) Use paragraph 3, excluding subparagraphs 3.C.(2)(b),
3.D.(2) and 3.G, of RR Alert Non-Modification Service Bulletin
(NMSB) RB.211-72-AH465, Revision 2, dated May 11, 2016, to perform
the inspections required by this AD.
    (2) Use of Replacement Blades
    (i) After the effective date of this AD, LP compressor blade, P/
N FK23411, FK25441, FK25968, FW11901, FW15393, FW23643, FW23741,
FW23744, KH23403, or KH23404, that has accumulated at least 2,400
CSN or CSLI is eligible for installation if the blade has passed the
UI required by this AD.
    (ii) Reserved.

(f) Credit for Previous Actions

    You may take credit for the UI required by paragraph (e) of this
AD, if you performed the UI before the effective date of this AD
using RR NMSB No. RB.211-72-G702, dated May 23, 2011; or RR NMSB No.
RB.211-72-G872, Revision 2, dated March 8, 2013, or earlier
revisions; or RR NMSB No. RB.211-72-H311, dated March 8, 2013; or
the Engine Manual E-Trent-1RR, Task 72-31-11-200-806.

(g) Alternative Methods of Compliance (AMOCs)

    The Manager, Engine Certification Office, may approve AMOCs for
this AD. Use the procedures found in 14 CFR 39.19 to make your
request. You may email your request to<EMAIL_ADDRESS>
(h) Related Information

    (1) For more information about this AD, contact Robert Green,
Aerospace Engineer, Engine Certification Office, FAA, Engine &
Propeller Directorate, 1200 District Avenue, Burlington, MA 01803;
phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email<EMAIL_ADDRESS>    (2) Refer to MCAI European Aviation Safety Agency AD 2016-0141,
dated July 20, 2016, for more information. You may examine the MCAI
in the AD docket on the Internet at http://www.regulations.gov by
searching for and locating it in Docket No. FAA-2012-1327.
    (3) RR Alert NMSB RB.211-72-AH465, Revision 2, dated May 11,
2016, can be obtained from RR, using the contact information in
paragraph (h)(4) of this AD.
    (4) For service information identified in this AD, contact
Rolls-Royce plc, P.O. Box 31, Derby DE24 8BJ, UK; phone: 44 0 1332
242424; fax: 44 0 1332 249936.
    (5) You may view this service information at the FAA, Engine &
Propeller Directorate, 1200 District Avenue, Burlington, MA. For
information on the availability of this material at the FAA, call
781-238-7125.

    Issued in Burlington, Massachusetts, on October 26, 2016.
Colleen M. D'Alessandro,
Manager, Engine & Propeller Directorate, Aircraft Certification
Service.
[FR Doc. 2016-26334 Filed 10-31-16; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 83, Number 245 (Friday, December 21, 2018)]
[Notices]
[Pages 65681-65683]
[FR Doc No: 2018-27656]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0520]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Substances Prohibited From Use in Animal Food or Feed;
Animal Proteins Prohibited in Ruminant Feed

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information, and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on the recordkeeping requirements regarding
animal proteins prohibited in ruminant feed.

DATES: Submit either electronic or written comments on the collection
of information by February 19, 2019.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before February 19, 2019. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of February 19, 2019. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or

anyone else's Social Security number, or confidential business
information, such as a manufacturing process. Please note that if you
include your name, contact information, or other information that
identifies you in the body of your comments, that information will be
posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2013-N-0520 for '' Substances Prohibited From Use in Animal Food or
Feed; Animal Proteins Prohibited in Ruminant Feed.'' 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.
     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 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.gpo.gov/fdsys/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.

FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Substances Prohibited From Use in Animal Food or Feed; Animal Proteins
Prohibited in Ruminant Feed--21 CFR 589.2000(e)(1)(iv) OMB Control
Number 0910-0339--Extension

    Section 701(a) (21 U.S.C. 371(a)) of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) gives us the authority to issue regulations for
the efficient enforcement of the FD&C Act. Our regulation at 21 CFR
589.2000 provides that animal protein derived from mammalian tissue
(with some exclusions) is not generally recognized as safe (GRAS) for
use in ruminant feed and is a food additive subject to certain
provisions of the act (62 FR 30936, June 5, 1997).
    This information collection was established because epidemiological
evidence gathered in the United Kingdom suggested that bovine
spongiform encephalopathy (BSE), a progressively degenerative central
nervous system disease, is spread to ruminant animals by feeding
protein derived from ruminants infected with BSE. This regulation
places general requirements on persons that manufacture, blend,
process, and distribute products that contain, or may contain, protein
derived from mammalian tissue, and feeds made from such products.
    Specifically, this regulation requires renderers, feed
manufacturers, and others involved in feed and feed ingredient
manufacturing and distribution to maintain written procedures
specifying the cleanout procedures or other means and specifying the
procedures for separating products that contain or may contain protein
derived from mammalian tissue from all other protein products from the
time of receipt until the time of shipment. These written procedures
are intended to help the firm formalize their processes, and then to
help inspection personnel confirm that the firm is operating in
compliance with the regulation. Inspection personnel will evaluate the
written procedure and confirm it is being followed when they are
conducting an inspection.
    These written procedures must be maintained as long as the facility
is operating in a manner that necessitates the record, and if the
facility makes changes to an applicable procedure or process the record
must be updated. Written procedures required by this

section shall be made available for inspection and copying by FDA.
    Description of Respondents: Respondents include renderers, feed
manufacturers, and others involved in feed and feed ingredient
manufacturing and distribution.
    FDA estimates the burden of this collection of information as
follows:

                                                   Table 1--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                               Number of      Number of records     Total annual      Average burden
                 21 CFR Section; activity                    recordkeepers     per recordkeeper       records       per recordkeeping     Total hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
589.2000(e)(1)(iv); written procedures...................                320                  1                320                 14              4,480
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    We base our estimates on our experience with similar requirements
to maintain written procedures. We base our estimate of the number of
recordkeepers on inspectional data. Based on a review of the
information collection since our last request for OMB approval, we have
made no adjustments to our burden estimate.

    Dated: December 17, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-27656 Filed 12-20-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 80, Number 30 (Friday, February 13, 2015)]
[Notices]
[Pages 8089-8091]
[FR Doc No: 2015-02976]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-2187]

Identifying Potential Biomarkers for Qualification and Describing
Contexts of Use To Address Areas Important to Drug Development; Request
for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for comments.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is seeking
information to facilitate development and qualification of biomarkers
in areas related to human drug therapeutics. Towards this goal, FDA is
encouraging interested groups and individuals to submit information on
specific medical and biological areas where novel biomarkers can be
identified that would meaningfully advance drug development. FDA
encourages respondents to describe evidentiary considerations that are
important to qualify these biomarkers for a specific context of use.
Details of information that should be provided to the Agency are
described in the survey.

DATES: Submit either electronic or written comments by April 14, 2015.

ADDRESSES: You may submit comments by any of the following methods:

Electronic Submissions

    Submit electronic comments in either of the following ways:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.
     SurveyMonkey Link: https://www.surveymonkey.com/s/RHJLHS7.
This survey may be used to provide feedback on answers to questions
regarding potential biomarkers for qualification and to describe
contexts of use to address areas important to drug development.

Written Submissions

    Submit written submissions in the following ways:
     Mail/Hand delivery/Courier (for paper submissions):
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the Docket No.
FDA-2014-N-2187 for this document. All comments received may be posted
without change to http://www.regulations.gov, including any personal
information provided. It is only necessary to send one set of comments.
For additional information on submitting comments, see the ``Request
for Information'' heading of the SUPPLEMENTARY INFORMATION section of
this document.
    Docket: For access to the docket to read background documents or
comments received, go to http://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 Division of
Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852,
between 9 a.m. and 4 p.m., Monday through Friday.

FOR FURTHER INFORMATION CONTACT: Marianne Noone, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 21, Rm. 4528, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    The President signed into law the Food and Drug Administration
Safety and Innovation Act (FDASIA) (Pub. L. 112-144) on July 9, 2012.
Title I of FDASIA reauthorizes the Prescription Drug User Fee Act
(PDUFA) and provides FDA with the user fee resources necessary to
maintain an efficient review process for human drug and biological
products. The reauthorization of PDUFA added performance goals and
procedures for the Agency that represent FDA's commitments during
fiscal years 2013 through 2017. These commitments are fully described
in the document entitled ``PDUFA Reauthorization Performance Goals and
Procedures Fiscal Years 2013 through 2017'' (PDUFA Goals Letter),
available on FDA's Web site at http://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM270412.pdf. Section IX
of the PDUFA Goals Letter entitled ``Enhancing Regulatory Science and
Expediting Drug Development'' references support for the identification
and advancement of biomarkers.
    A biomarker is an objective characteristic that is measured and
evaluated as an indicator of normal biologic processes, pathogenic
processes, or pharmacologic responses to treatment. Biomarkers can
serve many purposes in clinical drug development, including the
following: Defining the appropriate patient populations for study, as
well as those who should receive the drug in clinical practice;
pharmacodynamic markers for proof of concept and dose selection; and
pharmacodynamic markers of adverse effects. A subset of pharmacodynamic
biomarkers can serve as replacements for clinical efficacy endpoints
that reflect how a patient feels, functions, or survives. The path to
development of promising therapeutics can be enabled by the
availability of biomarkers that are analytically validated and
clinically qualified for a specific context of use (i.e., a
comprehensive, clear, and precise statement that describes the manner
of use, interpretation, and purpose of use of a biomarker in drug
development).
    Qualification is based on a body of evidence that demonstrates that
the biomarkers are fit for purpose in drug development and evaluation
(http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DrugDevelopmentToolsQualificationProgram/ucm284076.htm). Further,
qualification is dependent on the specific proposed context of use.
Biomarkers that are qualified can help to progressively reduce
uncertainty about the outcome of clinical development programs.
    Public/private partnerships involving regulatory, academic, and
industry scientists, collaborating within a precompetitive framework,
are essential to catalyzing progress. Because of limitations in
resources, such efforts must be focused on the opportunities that offer
the greatest potential for impact.
    FDA intends to facilitate identification of the most promising
biomarkers and the areas important to drug development and to promote
efforts that will aid in the qualification and regulatory adoption of
the drug development framework.

II. Request for Information

    FDA is seeking public feedback to identify promising biomarker
candidates in areas important to drug development and to identify
considerations for evidence needed to qualify various types of
biomarkers for specific contexts of use. FDA requests identification of
specific biomarkers with a proposed context of use and of the type of
evidence needed to support qualification. After reviewing the
information provided, FDA will post the collated information on its Web
site.

A. Information Requirements

    In general, submitted information should include the following for
each biomarker nominated, as well as any other relevant information:
     Areas that have a critical need for biomarkers to assist
drug development;
     The name of the biomarker;
     The proposed context of use for the biomarker (if known);
     The reason why the biomarker should be considered, taking
into account its usefulness as a drug development tool; and
     Any evidence that should be developed to support
qualification of the biomarker.

B. Questions and Requests

    Specific questions and requests are as follows:
    1. Are there specific aspects of drug development that could be
enhanced through the development of biomarkers?
    a. Please list the specific applications of biomarkers that address
areas important to drug development.
    b. Please list the specific areas (for example, a specific disease
area or an organ toxicity) needed for development of biomarkers
important to drug development.
    c. Is there information or efforts which could be leveraged to
advance these areas? If yes, please describe.
    d. Are there areas that appear to be promising for the development
of new biomarkers and for which collaborative engagement from
stakeholders offers a path forward? If so, please explain.
     Are there groups positioned to accomplish this? If yes,
please describe.
    e. Are there barriers that preclude engagement or investment in
biomarkers for these priority areas? If yes, please explain.
    2. In each of these priority areas that are important to drug
development, please provide the following information:
    a. Biomarker: What specific biomarkers do you believe represent the
greatest near-term opportunity to establish utility in drug development
(i.e., that could be substantially advanced by facilitating discussion
and consensus building)?
    b. Rationale: Why should the biomarker(s) be included on the list,
taking into account its usefulness in regulatory decisionmaking as a
drug development tool?
    c. Context of use: Can you please describe/propose a specific
context of use for the biomarker(s)?
    d. Evidentiary gaps: To support the proposed context of use, what
do you see as the largest evidentiary gaps that need to be addressed to
permit ``fit for purpose'' qualification?
    e. How can these evidentiary gaps be addressed?
    f. Collaborative data sharing: Can any of these gaps be addressed
by collaborative data sharing of existing data versus prospective
studies specifically dedicated to addressing the gap?
    3. Please indicate your affiliation from the following list:
Academia, pharmaceutical sector, biotechnology sector, government,
professional organization, non-profit organization, clinician, patient
advocacy group, patient, or other (please provide specifics, if you
choose other).

III. Paperwork Reduction Act

    This Federal Register notice requests input from biomarker experts
from academia, the pharmaceutical industry, and government
organizations on the evidentiary standards for biomarkers or on the
expectations about data for qualification of different types of
biomarkers.
    This request is exempt from the Office of Management and Budget's
review under 5 CFR 1320.3(h)(4): Facts or opinions submitted in
response to general solicitations of comments from the public,
published in the Federal Register or other publications, regardless of
the form or format thereof,

provided that no person is required to supply specific information
pertaining to the commenter, other than that necessary for self-
identification, as a condition of the Agency's full consideration of
the comment.

    Dated: February 5, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-02976 Filed 2-12-15; 8:45 am]
BILLING CODE 4164-01-P