[Federal Register Volume 82, Number 109 (Thursday, June 8, 2017)]
[Rules and Regulations]
[Pages 26580-26582]
[FR Doc No: 2017-11781]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2017-0016; Directorate Identifier 2016-NE-31-AD;
Amendment 39-18917; AD 2017-12-02]
RIN 2120-AA64

Airworthiness Directives; General Electric Company Turbofan
Engines

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: We are adopting a new airworthiness directive (AD) for certain
General Electric Company (GE) GEnx-1B64, -1B64/P1, -1B64/P2, -1B67, -
1B67/P1, -1B67/P2, -1B70, -1B70/P1, -1B70/P2, -1B70/75/P1, -1B70/75/P2,
-1B70C/P1, -1B70C/P2, -1B74/75/P1, -1B74/75/P2, -1B76A/P2 turbofan
engines. This AD was prompted by a fracture of the fuel manifold which
led to an in-flight shutdown of the engine. This AD requires
replacement of the outer left side signal fuel manifold with a part
eligible for installation. We are issuing this AD to address the unsafe
condition on these products.

DATES: This AD is effective July 13, 2017.

ADDRESSES: For service information identified in this final rule,
contact General Electric Company, GE-Aviation, Room 285, 1 Neumann Way,
Cincinnati, OH 45215, phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>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. It is also available on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2017-
0016.

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-2017-
0016; 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 final rule, the regulatory evaluation, any comments
received, and other information. The address for the Docket Office
(phone:<PHONE_NUMBER>) is Document Management Facility, U.S. Department
of Transportation, Docket Operations, M-30, West Building

Ground Floor, Room W12-140, 1200 New Jersey Avenue SE., Washington, DC
20590.

FOR FURTHER INFORMATION CONTACT: Christopher McGuire, Aerospace
Engineer, Engine Certification Office, FAA, Engine & Propeller
Directorate, 1200 District Avenue, Burlington, MA 01803; phone: 781-
238-7120; fax:<PHONE_NUMBER>; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 by adding an AD that would apply to all GEnx-1B64, -1B64/P1, -
1B64/P2, -1B67, -1B67/P1, -1B67/P2, -1B70, -1B70/P1, -1B70/P2, -1B70/
75/P1, -1B70/75/P2, -1B70C/P1, -1B70C/P2, -1B74/75/P1, -1B74/75/P2, -
1B76A/P2 engines with outer left side signal fuel manifold, part number
(P/N) 2403M46G01, and CAGE code 05813, installed. The NPRM published in
the Federal Register on February 28, 2017 (82 FR 12070) (``the NPRM'').
The NPRM was prompted by a fracture of the fuel manifold which led to
an in-flight shutdown of the engine. The NPRM proposed to require
replacement of the outer left side signal fuel manifold with a part
eligible for installation. We are issuing this AD to prevent fracture
of the fuel manifold, engine fire, and damage to the airplane.

Comments

    We gave the public the opportunity to participate in developing
this final rule. The following presents the comments received on the
NPRM and the FAA's response to each comment.

Request To Reduce Compliance Time

    The Air Line Pilots Association (ALPA) requested that the FAA
reduce the compliance time in this AD from 12 months to 60 days. ALPA
commented that the service bulletin (SB) recommends replacement of the
left side signal fuel manifold within 60 days of issuance of the SB.
    We disagree. Our risk assessment of the potential for additional
fuel manifold fractures indicates that 12 months represents an
acceptable level of risk for replacement of the affected fuel
manifolds. We did not change this AD.

Request To Withdraw NPRM

    United Airlines (United) requested that the NPRM be withdrawn.
United commented that they have already accomplished the requirements
of this AD and removed all affected parts from stock. United noted that
GE has reported that this issue has been resolved by all operators.
United indicated that this AD will therefore only generate unnecessary
work.
    We disagree. This AD includes an installation prohibition that
prevents any non-conforming parts from being re-installed into engines.
Without this prohibition, a non-conforming part could be installed into
an engine and re-enter service. We did not change this AD.

Request To Revise Applicability

    Japan Airlines (JAL) requested that the applicability of this AD be
revised so that it lists affected engine serial numbers instead of
applicable engines with the affected part installed. JAL indicated that
GE no longer delivers engines with the affected parts installed.
    We disagree. This AD includes an installation prohibition to
prevent the affected outer left side signal fuel manifold from being
re-installed in any engine. By defining applicability according to the
affected engine with the outer left side signal fuel manifold, P/N
2403M46G01, and CAGE code 05813, installed, we ensure that all the
affected parts are removed from service and not re-installed in any
engine. We did not change this AD.

Request To Clarify Compliance Using SB

    JAL commented that they believe the AD should allow replacement of
the affected outer left side signal fuel manifold using GE GEnx-1B SB
73-0053 R00, dated November 15, 2016.
    We agree. This AD does not specify which service material to use
when replacing the outer left side signal fuel manifold. This AD lists
GE service bulletins, including GEnx-1B SB 73-0053 R00, dated November
15, 2016, as guidance when inspecting, repairing, and replacing the
outer left side signal fuel manifold. Therefore, this AD already allows
use of GEnx-1B SB 73-0053 R00 when complying with this AD. We did not
change this AD.

Request That AD Not Apply to New Engines

    JAL requested that newly-delivered engines, which are not covered
by GEnx-1B SB 73-0053 R00, dated November 15, 2016, should be
considered as ``not applicable to this AD.''
    We partially agree. We agree that this AD does not apply to new
engines that do not have the affected fuel manifold installed. We
disagree with changing the applicability of this AD because we do not
want to allow an affected part to be installed later on a new engine.
We did not change this AD.

Support for the NPRM

    GE expressed support for the NPRM as written.

Conclusion

    We reviewed the relevant data, considered the comments received,
and determined that air safety and the public interest require adopting
this final rule as proposed.

Related Service Information

    We reviewed GE GEnx-1B SB 73-0051 R00, dated November 4, 2016; GE
GEnx-1B SB 73-0052 R00, dated October 28, 2016; and GE GEnx-1B SB 73-
0053 R00, dated November 15, 2016. These SBs describe, respectively,
procedures for inspecting, repairing, and replacing the outer left side
signal fuel manifold, part number 2403M46G01, and CAGE code 05813.

Costs of Compliance

    We estimate that this AD affects 109 engines installed on airplanes
of U.S. registry.
    We estimate the following costs to comply with this AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per      Cost on U.S.
                Action                         Labor cost           Parts cost        product        operators
----------------------------------------------------------------------------------------------------------------
Replacement of fuel manifold..........  2 work-hours x $85 per           $16,000         $16,170      $1,762,530
                                         hour = $170.
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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

    This AD will not have federalism implications under Executive Order
13132. This AD will not have a substantial direct effect on the States,
on the relationship between the national government and the States, or
on the distribution of power and responsibilities among the various
levels of government.
    For the reasons discussed above, I certify that this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Is not a ``significant rule'' under DOT Regulatory Policies and
Procedures (44 FR 11034, February 26, 1979),
    (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.

Adoption of the Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13   [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive (AD):

2017-12-02 General Electric Company: Amendment 39-18917; Docket No.
FAA-2017-0016; Directorate Identifier 2016-NE-31-AD.

(a) Effective Date

    This AD is effective July 13, 2017.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to all GEnx-1B64, -1B64/P1, -1B64/P2, -1B67, -
1B67/P1, -1B67/P2, -1B70, 1B70/P1, -1B70/P2, -1B70/75/P1, -1B70/75/
P2, -1B70C/P1, -1B70C/P2, -1B74/75/P1, -1B74/75/P2, -1B76A/P2
engines with outer left side signal fuel manifold, part number (P/N)
2403M46G01, and CAGE code 05813, installed.

(d) Subject

    Joint Aircraft System Component (JASC) Code 7313, Fuel Injector
Nozzle.

(e) Unsafe Condition

    This AD was prompted by fracture of the fuel manifold which led
to an in-flight shutdown of the engine. We are issuing this AD to
prevent fracture of the fuel manifold, engine fire, and damage to
the airplane.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.
    (1) Inspect the outer left side signal fuel manifold, P/N
2403M46G01 and CAGE code 05813, to determine if the part has
additional marking ``XB,'' ``INS,'' or ``KB'' adjacent to part
number. If the part is marked with ``XB,'' ``INS,'' or ``KB,'' then
no further action is required.
    (2) For parts without additional marking ``XB,'' ``INS,'' or
``KB'' adjacent to the part number, within 12 months after the
effective date of this AD, replace the outer left side signal fuel
manifold with a part eligible for installation.

(g) Installation Prohibition

    After the effective date of this AD, do not install an outer
left side signal fuel manifold, P/N 2403M46G01, and CAGE code 05813,
onto an engine, unless additional marking ``XB,'' ``INS,'' or ``KB''
is adjacent to the part number.

(h) Alternative Methods of Compliance (AMOCs)

    The Manager, Engine Certification Office, FAA, 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>
(i) Related Information

    (1) For more information about this AD, contact Christopher
McGuire, 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) GE GEnx-1B Service Bulletin (SB) 73-0051 R00, dated November
4, 2016; GE GEnx-1B SB 73-0052 R00, dated October 28, 2016; and GE
GEnx-1B SB 73-0053 R00, dated November 15, 2016, can be obtained
from GE using the contact information in paragraph (i)(3) of this
AD. These SBs, respectively, describe procedures for inspecting,
repairing, and replacing the outer left side signal fuel manifold.
    (3) For service information identified in this AD, contact
General Electric Company, GE-Aviation, Room 285, 1 Neumann Way,
Cincinnati, OH 45215, phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>    (4) 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.

(j) Material Incorporated by Reference

    None.

    Issued in Burlington, Massachusetts, on May 30, 2017.
Robert J. Ganley,
Acting Manager, Engine & Propeller Directorate, Aircraft Certification
Service.
[FR Doc. 2017-11781 Filed 6-7-17; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 80, Number 191 (Friday, October 2, 2015)]
[Notices]
[Pages 59785-59786]
[FR Doc No: 2015-25122]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-D-3235]

M4E(R2): The Common Technical Document--Efficacy; International
Conference on Harmonisation; Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance entitled ``M4E(R2): The CTD--
Efficacy'' (M4E(R2)). The draft guidance was prepared under the
auspices of the International Conference on Harmonisation of Technical
Requirements for Registration of Pharmaceuticals for Human Use (ICH).
In August 2001, FDA made available guidance on preparing the efficacy
components of an application file in the common technical document
(CTD) format (``M4E: The CTD--Efficacy'' (M4E guidance)). This draft
guidance revises the M4E guidance. The revised draft guidance
standardizes the presentation of benefit-risk information in regulatory
submissions, providing greater specificity on the format and structure
of benefit-risk information. This revision is intended to facilitate
communication among regulators and industry.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115 (g)(5)), to ensure that the Agency considers your comment on
this draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by December 1, 2015.

ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information (HFD-240), Center for Drug
Evaluation and Research (CDER), Food and Drug Administration, 10001 New
Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD
20993-0002, or the Office of Communication, Outreach, and Development,
Center for Biologics Evaluation and Research (CBER), Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver
Spring, MD 20993-0002. Send one self-addressed adhesive label to assist
the office in processing your requests. The draft guidance may also be
obtained by mail by calling CBER at 1-800-835-4709 or<PHONE_NUMBER>. See
the SUPPLEMENTARY INFORMATION section for electronic access to the
draft guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Regarding the guidance: Pujita Vaidya,
Center for Drug Evaluation and Research, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 51, Rm. 1144, Silver Spring, MD 20993-
0002,<PHONE_NUMBER>; or Stephen Ripley, Center for Biologics Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.
    Regarding the ICH: Michelle Limoli, Center for Drug Evaluation and
Research, International Programs, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm. 7212, Silver Spring, MD 20993-0002,
301-796-8377.

SUPPLEMENTARY INFORMATION:

I. Background

    In recent years, many important initiatives have been undertaken by
regulatory authorities and industry associations to promote
international harmonization of regulatory requirements. FDA has
participated in many meetings designed to enhance harmonization and is
committed to seeking scientifically based and harmonized technical
procedures for pharmaceutical development. One of the goals of
harmonization is to identify and reduce differences in technical
requirements for drug development among regulatory Agencies.
    ICH was organized to provide an opportunity for tripartite
harmonization initiatives to be developed with input from both
regulatory and industry representatives. FDA also seeks input from
other interested stakeholders. ICH is concerned with harmonization of
technical requirements for the registration of pharmaceutical products
among three regions: Europe, Japan, and North America. The eight ICH
sponsors are the European Commission; the European Federation of
Pharmaceutical Industries Associations; the Japanese Ministry of
Health, Labour, and Welfare; the Japanese Pharmaceutical Manufacturers
Association; CDER and CBER, FDA; the Pharmaceutical Research and
Manufacturers of America; Health Canada; and Swissmedic. The ICH
Secretariat, which coordinates the preparation of documentation, is
provided by the International Federation of Pharmaceutical
Manufacturers Associations (IFPMA). The ICH Steering Committee includes
representatives from each of the ICH sponsors and the IFPMA, as well as
observers such as the World Health Organization. In August 2015, the
ICH Steering Committee agreed that a draft guidance entitled ``M4E(R2):
The CTD--Efficacy'' should be made available for public comment. The
draft guidance is the product of the M4E(R2) Expert Working Group of
the ICH. Comments about this draft will be considered by FDA and the
Expert Working Group.
    ICH M4E(R2) revises the M4E guidance (made available in August
2001), which covers the Clinical Overview and Clinical Summary of
Module 2 of the CTD and the Clinical Study Reports of Module 5. The
revised draft guidance provides more specific guidance regarding the
format and structure of the benefit-risk assessment in section 2.5.6;
it also revises other sections of the guidance for clarification, given
the proposed revisions in section 2.5.6. In addition, the revised draft
guidance changes the numbering and the section headings for
consistency.
    Regulatory authorities approve drugs that are demonstrated to be
safe and effective for human use. The meaning of ``safe'' has
historically been interpreted to mean that the benefits of the drug
outweigh its risks. This benefit-risk assessment of pharmaceuticals is
the fundamental basis of regulatory decision-making. In the last
several years, providing greater structure for the benefit-risk
assessment has been an important topic in drug regulation. The M4E
guidance directs applicants to include their conclusions on benefits
and risks in the Clinical Overview of Module 2 of the CTD under section
2.5.6. Although general guidance is provided in the M4E guidance
regarding the expected content of section 2.5.6, no further structure
is suggested to aid industry in developing the benefit-risk assessment.
As a result, regulators observe a high degree of variability in the
approaches taken by applicants in presenting this information. This
variability may not facilitate efficient communication of industry
views to regulators. Although regulators and industry have developed
approaches for structured benefit-risk assessment and these approaches
may take different forms, there is a common thread evident that can
inform harmonization of the format and structure of benefit-risk

assessments provided by applicants in their regulatory submissions.
    Recognizing that there are many reasonable approaches for
conducting a benefit-risk assessment, M4E(R2) does not specify a
particular approach to be used by industry. However, the document does
offer specific guidance on the major elements that should be included
in the benefit-risk assessment. Furthermore, consistent with the
concept paper that laid the groundwork for the Expert Working Group,
the revised draft guidance does not dictate an approach used by a
regulator in conducting a benefit-risk assessment.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on this topic. It
does not establish any rights for any person and is not binding on FDA
or the public. You can use an alternative approach if it satisfies the
requirements of the applicable statutes and regulations.

II. Comments

    Interested persons may submit either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

III. Electronic Access

    Persons with access to the Internet may obtain the document at
http://www.regulations.gov, http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or
http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.

    Dated: September 28, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-25122 Filed 10-1-15; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 78, Number 43 (Tuesday, March 5, 2013)]
[Notices]
[Page 14298]
[FR Doc No: 2013-04925]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings 1

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

    Docket Numbers: EC13-75-000.
    Applicants: Wolverine Power Supply Cooperative, Inc., Wisconsin
Electric Power Company.
    Description: Wolverine Power Supply Cooperative, Inc. et al
Application for Authorization for Disposition of Jurisdictional
Facilities Pursuant to Federal Power Act Section 203 & Request for
limited Waivers & Confidential Treatment.
    Filed Date: 2/22/13.
    Accession Number: 20130222-5142.
    Comments Due: 5 p.m. ET 3/15/13.

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

    Docket Numbers: ER12-513-006.
    Applicants: PJM Interconnection, L.L.C.
    Description: Compliance filing per 1/31/2013 Order accepting
Settlement Agreement in ER12-513 to be effective 1/31/2013.
    Filed Date: 2/22/13.
    Accession Number: 20130222-5077.
    Comments Due: 5 p.m. ET 3/15/13.

    Docket Numbers: ER13-973-000.
    Applicants: Saja Energy LLC.
    Description: Market-Based Rates application to be effective 2/23/
2013.
    Filed Date: 2/22/13.
    Accession Number: 20130222-5106.
    Comments Due: 5 p.m. ET 3/15/13.

    Docket Numbers: ER13-974-000.
    Applicants: Dynegy Midwest Generation, LLC.
    Description: Revised Rate Schedule to be effective 12/31/1998.
    Filed Date: 2/22/13.
    Accession Number: 20130222-5115.
    Comments Due: 5 p.m. ET 3/15/13.

    Docket Numbers: ER13-975-000.
    Applicants: Pacific Gas and Electric Company.
    Description: Western's WPA (Cottonwood Phase 2), Rate Schedule FERC
No 228 to be effective 2/25/2013.
    Filed Date: 2/22/13.
    Accession Number: 20130222-5123.
    Comments Due: 5 p.m. ET 3/15/13.

    Docket Numbers: ER13-976-000.
    Applicants: Arizona Public Service Company.
    Description: Arizona Public Service files Navajo Generating Station
Operating Agreement to be effective 4/23/2013.
    Filed Date: 2/22/13.
    Accession Number: 20130222-5128.
    Comments Due: 5 p.m. ET 3/15/13.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: February 25, 2013.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2013-04925 Filed 3-4-13; 8:45 am]
BILLING CODE 6717-01-P