[Federal Register Volume 78, Number 35 (Thursday, February 21, 2013)]
[Rules and Regulations]
[Pages 11976-11978]
[FR Doc No: 2013-03708]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2011-0624; Directorate Identifier 2010-NE-11-AD;
Amendment 39-17358; AD 2013-04-01]
RIN 2120-AA64

Airworthiness Directives; Rolls-Royce plc Turbofan Engines

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule; request for comments.

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SUMMARY: We are superseding an existing airworthiness directive (AD)
for all Rolls-Royce plc (RR) RB211-524 series turbofan engines. That AD
currently requires removal and repair of certain thrust reverser units
(TRUs) prior to reinstallation. This AD requires the same actions for
an expanded population of TRUs and extends the compliance time for
repairing certain TRUs. This AD was prompted by additional engineering
evaluation of TRUs, as a result of a translating cowl gearbox stubshaft
failure and subsequent repair. We are issuing this AD to prevent
failure of the attachment rivets, which may result in release of the
TRU from the engine.

DATES: This AD is effective March 8, 2013.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in the AD as of March 8,
2013.
    The Director of the Federal Register approved the incorporation by
reference of a certain other publication as of August 12, 2011, (76 FR
40217, July 8, 2011).
    We must receive any comments on this AD by April 8, 2013.

ADDRESSES: You may send comments 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 AD, contact Rolls-Royce
plc, Corporate Communications, P.O. Box 31, Derby, England, DE248BJ;
phone: 011-44-1332-242424; fax: 011-44-1332-249936, or email: http://www.rolls-royce.com/contact/civil_team.jsp. You may view this service
information at the FAA, Engine & Propeller Directorate, 12 New England
Executive Park, Burlington, MA 01803. 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; 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 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: Robert Green, Aerospace Engineer,
Engine Certification Office, FAA, Engine & Propeller Directorate, 12
New England Executive Park, Burlington, MA 01803; phone:<PHONE_NUMBER>;
fax:<PHONE_NUMBER>; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Discussion

    On June 8, 2011, we issued AD 2011-13-01, Amendment 39-16724 (76 FR
40217, July 8, 2011), for all RR plc RB211-524 series turbofan engines.
That AD required removal and repair of certain TRUs prior to
reinstallation. That AD resulted from an investigation into the loss of
a TRU during landing. The investigation revealed that the incident was
preceded by the detachment of the TRU's fixed structure front ring
rivet lines on the rear flange. It was determined that the loss of
rivet lines was directly associated with a previous translating cowl
gearbox stubshaft fracture and the repair of the fixed structure to
Engine Manual repair No. FRS5887. At the time, the repair instructed
the replacement of the damaged section of the structure but did not
require the rivets adjacent to the repair to be replaced. Subsequent
analysis has shown that the rivets may have weakened as a result of the
translating cowl gearbox stubshaft failure.

Actions Since AD Was Issued

    Since we issued AD 2011-13-01, (76 FR 40217, July 8, 2011),
engineering evaluation by RR has concluded that the compliance time for
repairing TRUs that had only Engine Manual repair No. FRS5887
incorporated as a result of a translating cowl gearbox stubshaft
failure, can be extended. RR also concluded that TRUs previously
repaired at the front ring with additional rivets using Engine Manual
repair No. FRS5887 Part 2, and that have not had Engine Manual repair
Nos. FRS4976 and FRS6669 applied to the rear ring at the No. 2 or No. 3
gearbox position, constitute a new population that must be removed and
repaired during the next scheduled engine removal. The European
Aviation Safety Agency (EASA) has notified us of this same unsafe
condition, and corrective actions described in EASA AD 2012-0255, dated
November 30, 2012.

Relevant Service Information

    We reviewed RR Alert Non-Modification Service Bulletin (NMSB) No.
RB.211-78-AG084, Revision 7, dated November 23, 2012. The NMSB
describes procedures for removal, repair, and reinstallation of
affected TRUs.

FAA's Determination

    We are issuing 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.

AD Requirements

    This AD requires removal and repair of TRUs that experienced a cowl
gearbox stubshaft failure with subsequent repair of the fixed structure
to Engine Manual repair No. FRS5887. This AD also requires removal and
repair of TRUs previously repaired at the front ring with additional
rivets using Engine Manual repair No. FRS5887 Part 2, and that have not
had Engine Manual repair Nos. FRS4976 and FRS6669 applied to the rear
ring at the No. 2 or No. 3 gearbox position.

FAA's Justification and Determination of the Effective Date

    The FAA has found that notice and comment prior to adoption of this
rule is unnecessary because no engines are used on U.S. registered
airplanes. Therefore, we find that good cause exists for making this
amendment effective in less than 30 days.

Comments Invited

    This AD is a final rule that involves requirements affecting flight
safety, and we did not provide you with notice and an opportunity to
provide your comments before it becomes effective. However, we invite
you to send any

written data, views, or arguments about this AD. Send your comments to
an address listed under the ADDRESSES section. Include the Docket No.
FAA-2011-0624 and Directorate Identifier 2010-NE-11-AD at the beginning
of your comments. We specifically invite comments on the overall
regulatory, economic, environmental, and energy aspects of this AD. We
will consider all comments received by the closing date and may amend
this 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 AD.

Costs of Compliance

    We estimate that this AD will not affect any engines installed on
airplanes of U.S. registry. Therefore, we estimate the cost of this AD
to U.S. operators to be $0.

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 part 39 of the Federal Aviation
Regulations (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)
2011-13-01, Amendment 39-16724 (76 FR 40217, July 8, 2011) and adding
the following new AD:

2013-04-01 Rolls-Royce plc: Amendment 39-17358; Docket No. FAA-2011-
0624; Directorate Identifier 2010-NE-11-AD.

(a) Effective Date

    This AD is effective March 8, 2013.

(b) Affected ADs

    This AD supersedes AD 2011-13-01, Amendment 39-16724 (76 FR
40217, July 8, 2011).

(c) Applicability

    This AD applies to Rolls-Royce plc (RR) RB211-524D4-19, -524D4-
B-19, -524D4-39, -524D4-B-39, -524D4X-19, -524D4X-B-19, -524H-36, -
524H2-19, -524H-T-36, -524H2-T-19, -524G2-19, -524G3-19, -524G2-T-
19, and -524G3-T-19 turbofan engines with thrust reverser units
(TRUs) that have a part number (P/N) specified in paragraph 1.A. of
RR Alert Non-Modification Service Bulletin (NMSB) No. RB.211-78-
AG084, Revision 7, dated November 23, 2012, installed.

(d) Unsafe Condition

    This AD was prompted by additional engineering evaluation of
TRUs, as a result of a translating cowl gearbox stubshaft failure
and subsequent repair. We are issuing this AD to prevent failure of
the attachment rivets, which may result in release of the TRU from
the engine.

(e) Compliance

    Comply with this AD within the compliance times specified,
unless already done.
    (1) If no repairs were performed as a result of a stubshaft
failure, no further action is necessary.
    (2) If before December 14, 2009, the TRU has incorporated Engine
Manual repair No. FRS5887 and incorporated either Engine Manual
repair No. FRS4976 or No. FRS6669 as a result of a translating cowl
gearbox stubshaft failure, then repair the TRU before further
flight. Use the procedures in Section 3., Accomplishment
Instructions, of RR Alert NMSB No. RB.211-78-AG084, Revision 5,
dated February 4, 2011, to do the repair.
    (3) If before December 14, 2009, the TRU has incorporated Engine
Manual repair No. FRS4976, or No. FRS6669 as a result of a
translating cowl gearbox stubshaft failure, and it is not known
whether Engine Manual repair No. FRS5887 was incorporated
concurrently, then repair the TRU within 200 engine flight cycles
after the effective date of this AD. Use the procedures in Section
3., Accomplishment Instructions, of RR Alert NMSB No. RB.211-78-
AG084, Revision 5, dated February 4, 2011, to do the repair.
    (4) If before December 14, 2009, the TRU has incorporated only
Engine Manual repair No. FRS5887 as a result of a translating cowl
gearbox stubshaft failure, then repair the TRU within 1,150 engine
flight cycles after the effective date of this AD. Use the
procedures in Section 3., Accomplishment Instructions, of RR Alert
NMSB No. RB.211-78-AG084, Revision 7, dated November 23, 2012, to do
the repair.
    (5) If the TRU has previously been repaired at the front ring
with additional rivets using Engine Manual repair No. FRS5887 Part
2, and has not had Engine Manual repair Nos. FRS4976 and FRS6669
applied to the rear ring at the No. 2 or No. 3 gearbox position:
    (i) Remove the TRU from the engine during the next scheduled
engine removal after the effective date of this AD; and
    (ii) Before returning the TRU to service, repair the TRU using
the procedure in Section 3.A.(4), Accomplishment Instructions, of RR
Alert NMSB No. RB.211-78-AG084, Revision 7, dated November 23, 2012.

(f) Credit for Actions Accomplished in Accordance With Previous Service
Information

    (1) Actions performed before the effective date of this AD using
RR Alert NMSB No. RB.211-78-AG084, Revision 4, dated December 22,
2009, or RR Alert NMSB No. RB.211-78-AG084, Revision 3, dated
November 24, 2009, satisfy the requirements of paragraphs (e)(2) and
(e)(3) of this AD.
    (2) Actions performed before the effective date of this AD using
RR Alert NMSB No. RB.211-78-AG084, Revision 6, dated November 16,
2012, or Revision 5, dated February 4, 2011, or Revision 4, dated
December 22, 2009, or Revision 3, dated November 24, 2009, satisfy
the requirements of paragraph (e)(4) of this AD.
    (3) Actions performed before the effective date of this AD using
RR Alert NMSB No. RB.211-78-AG084, Revision 6, dated

November 16, 2012, satisfy the requirements of paragraph (e)(5)(ii)
of this AD.

(g) 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.

(h) Related Information

    (1) Refer to EASA Airworthiness Directive 2012-0255, dated
November 30, 2012, for related information.
    (2) Contact Robert Green, Aerospace Engineer, Engine
Certification Office, FAA, Engine & Propeller Directorate, 12 New
England Executive Park, Burlington, MA 01803; phone:<PHONE_NUMBER>;
fax:<PHONE_NUMBER>; email<EMAIL_ADDRESS>for more information
about this AD.

(i) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless the AD specifies otherwise.
    (i) Rolls-Royce plc Alert Non-Modification Service Bulletin No.
RB.211-78-AG084, Revision 7, dated November 23, 2012.
    (ii) Reserved.
    (3) The following service information was approved for IBR on
August 12, 2011, (76 FR 40217, July 8, 2011).
    (i) Rolls-Royce plc Alert Non-Modification Service Bulletin No.
RB.211-78-AG084, Revision 5, dated February 4, 2011.
    (ii) Reserved.
    (4) For Rolls-Royce plc service information identified in this
AD, contact Rolls-Royce plc, Corporate Communications, P.O. Box 31,
Derby, England, DE248BJ; phone: 011-44-1332-242424; fax: 011-44-
1332-249936, or email: http://www.rolls-royce.com/contact/civil_team.jsp.
    (5) You may view this service information at the FAA, Engine &
Propeller Directorate, 12 New England Executive Park, Burlington,
MA. For information on the availability of this material at the FAA,
call<PHONE_NUMBER>.
    (6) You may view this service information at the National
Archives and Records Administration (NARA). For information on the
availability of this material at NARA, call<PHONE_NUMBER>, or go to:
http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Burlington, Massachusetts, on February 7, 2013.
Robert J. Ganley,
Acting Manager, Engine & Propeller Directorate, Aircraft Certification
Service.
[FR Doc. 2013-03708 Filed 2-20-13; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 84, Number 128 (Wednesday, July 3, 2019)]
[Notices]
[Pages 31874-31875]
[FR Doc No: 2019-14147]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-1114]

Pharmaceutical Distribution Supply Chain Pilot Projects;
Reopening of Comment Period; Request for Information

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; reopening of comment period; request for information.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) is
reopening the comment period for the notices (requests for information)
that published in the Federal Register of April 15, 2016, and April 28,
2017. FDA is requesting comments regarding issues related to utilizing
the product identifier for product tracing, improving the technical
capabilities of the supply chain, and identifying system attributes
that are necessary to implement the requirements established under the
Drug Supply Chain Security Act (DSCSA). The information gathered from
reopening of the comment period will allow supply chain stakeholders to
share information about relevant piloting activities that are conducted
outside of FDA's DSCSA Pilot Project Program to inform DSCSA
implementation by FDA and supply chain stakeholders.

DATES: FDA is reopening the comment period on the notices (requests for
information) published April 15, 2016 (81 FR 22279), and April 28, 2017
(82 FR 19737). Submit either electronic or written comments by June 28,
2022.

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 June 28, 2022. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of June 28, 2022. 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-2016-N-1114 for ``Pharmaceutical Distribution Supply Chain Pilot
Projects; Reopening of Comment Period; Request for Information.''
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: Daniel Bellingham, Office of
Compliance, Center for Drug Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002,
301-796-3130<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: FDA is interested in comments regarding past
or present pilot projects related to enhancing the safety and security
of the pharmaceutical distribution supply chain; this may include
information related to piloting activities that are conducted outside
of FDA's DSCSA Pilot Project Program. Stakeholders that may be
interested in responding to this request for information include
manufacturers, repackagers, wholesale distributors, dispensers, State
and Federal authorities, solution providers, standards organizations,
and other interested persons. FDA is particularly interested in
learning about the practices, processes, and systems that supply chain
stakeholders have used or considered using in such pilot projects. This
includes, but is not limited to, information about the following:
     Utilizing the product identifier for tracing of a product,
which may include verification of the product identifier of a product,
including the use of aggregation and inference;
     Technical capabilities of each supply chain sector to
develop and implement the systems and processes needed to utilize the
product identifier to enhance the tracing of a product; or
     System attributes that are necessary to implement the
requirements established under the DSCSA.
    Interested persons are requested to provide any other relevant
information that may inform FDA's implementation of the requirements
for enhanced product tracing and verification under the DSCSA.
    FDA is reopening the comment period for the requests for
information for 3 years, until June 28, 2022. The Agency believes that
a 3-year comment period allows adequate time for interested persons to
submit new, additional, or updated comments on these important issues
as they work to implement requirements under the DSCSA.

    Dated: June 27, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-14147 Filed 7-2-19; 8:45 am]
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