[Federal Register Volume 78, Number 46 (Friday, March 8, 2013)]
[Proposed Rules]
[Pages 14934-14939]
[FR Doc No: 2013-05295]

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Proposed Rules
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.

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Federal Register / Vol. 78, No. 46 / Friday, March 8, 2013 / Proposed
Rules

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2010-1160; Directorate Identifier 2010-NM-148-AD]
RIN 2120-AA64

Airworthiness Directives; The Boeing Company Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

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

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SUMMARY: We are revising an earlier proposed airworthiness directive
(AD) to supersede an existing AD for certain The Boeing Company Model
767 airplanes. The existing AD currently requires repetitive
inspections to detect discrepancies of the wiring and surrounding
Teflon sleeves of the fuel tank boost pumps and override/jettison
pumps; replacement of the sleeves with new sleeves, for certain
airplanes; and repair or replacement of the wiring and sleeves with new
parts, as necessary. The first SNPRM proposed to reduce the initial
compliance time and repetitive inspection interval in the existing AD.
The first SNPRM also proposed to mandate a terminating action for the
repetitive inspections, to eliminate wire damage. In addition, the
first SNPRM proposed to remove certain airplanes from the applicability
of the existing AD. The first SNPRM was prompted by fleet information
indicating that the repetitive inspection interval in the existing AD
is too long, because excessive chafing of the sleeving continues to
occur much earlier than expected between scheduled inspections. This
action revises the first SNPRM by also proposing to require revising
the maintenance program to incorporate changes to the airworthiness
limitations section. We are proposing this second SNPRM to detect and
correct chafing of the fuel pump wire insulation and consequent
exposure of the electrical conductor, which could result in electrical
arcing between the wires and conduit and consequent fire or explosion
of the fuel tank. Since these actions impose an additional burden over
that proposed in the first SNPRM, we are reopening the comment period
to allow the public the chance to comment on these proposed changes.

DATES: We must receive comments on this proposed AD by April 22, 2013.

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 proposed AD, contact
Boeing Commercial Airplanes, Attention: Data & Services Management, P.
O. Box 3707, MC 2H-65, Seattle, Washington 98124-2207; telephone 206-
544-5000, extension 1; fax<PHONE_NUMBER>; Internet https://www.myboeingfleet.com. You may review copies of the referenced service
information at the FAA, Transport Airplane Directorate, 1601 Lind
Avenue SW., Renton, Washington. 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 proposed AD, the regulatory
evaluation, any comments received, and other information. The street
address for the Docket Office (phone:<PHONE_NUMBER>) is in the ADDRESSES
section. Comments will be available in the AD docket shortly after
receipt.

FOR FURTHER INFORMATION CONTACT: Rebel Nichols, Aerospace Engineer,
Propulsion Branch, ANM-140S, FAA, Seattle Aircraft Certification
Office, 1601 Lind Avenue SW., Renton, Washington 98057-3356; phone:
425-917-6509; fax:<PHONE_NUMBER>; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2010-1160;
Directorate Identifier 2010-NM-148-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD because of those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this proposed AD.

Discussion

    We issued a supplemental notice of proposed rulemaking (SNPRM) to
amend 14 CFR part 39 to supersede airworthiness directive (AD) 2000-11-
06, Amendment 39-11754 (65 FR 34928, June 1, 2000; corrected August 1,
2000 (65 FR 46862)). That first SNPRM would apply to certain Model 767-
200, -300, -300F, and -400ER series airplanes. The first SNPRM
published in the Federal Register on July 2, 2012 (77 FR 39188). The
first SNPRM proposed to continue to require repetitive inspections to
detect discrepancies of the wiring and surrounding Teflon sleeves of
the fuel tank boost pumps and override/jettison pumps; replacement of
the sleeves with new sleeves, for certain airplanes; and repair or
replacement of the wiring and sleeves with new parts, as necessary. The
first SNPRM also proposed to reduce the initial compliance time and
repetitive inspection interval in the existing AD, and remove certain
airplanes from the applicability of the existing AD. In addition, the
first SNPRM proposed to include a terminating action for the

repetitive inspections, to eliminate wire damage.

Actions Since First SNPRM Was Issued

    Since we issued the first SNPRM (77 FR 39188, July 2, 2012), we
have reviewed the information specified in Airworthiness Limitation
Instruction, Critical Design Configuration Control Limitations (CDCCL)
Task 28-AWL-29, ``In-Tank AC Fuel Pump Wire Bundles with Protective
Liner;'' and CDCCL Task 28-AWL-30, ``Fuel Boost Pump Wires in Conduit
Installation--In Fuel Tank;'' of Section 9 of Boeing 767 Airworthiness
Limitations (AWLs) and Certification Maintenance Requirements (CMRs),
D622T001-9, Revision October 2012. We have determined it is necessary
to revise the maintenance program to include these tasks in order to
address the identified unsafe condition.

Comments

    We gave the public the opportunity to participate in developing
this AD. The following presents the comments received on the proposal
(77 FR 39188, July 2, 2012), and the FAA's response to each comment.

Request To Change Terminating Action Requirement

    Air Canada (ACN) asked that the terminating action mandated by the
first SNPRM (77 FR 39188, July 2, 2012) be deemed optional. American
Airlines (AAL) stated that after complying with the inspections in the
first SNPRM, very little damage was found. AAL added that damage is
confined to the outer sleeve beyond 44,400 flight hours, and the wiring
damage does not occur until 17 years later when undisturbed. AAL
concluded that, given its service experience, Boeing's service data and
analysis and the proposed 15,000 flight-hour inspection interval, the
terminating action should not be mandated. ACN provided no
justification for its request.
    We do not agree with the commenters. Mandating the terminating
action is based on our determination that, in this case, long term
continued operational safety would be better ensured by a modification
to remove the source of the problem, rather than by repetitive
inspections. As a matter of policy, we have determined that long-term
inspections might not provide the degree of safety necessary for the
transport airplane fleet. This determination has led us to consider
placing less emphasis on inspections and more emphasis on design
improvements. The modification is consistent with these conditions.
Therefore, we have not changed the second SNPRM in this regard.

Request To Justify Existing Repetitive Inspection Interval

    ACN stated that it would like the FAA to confirm that the new
repetitive inspection interval proposed by Boeing is based on
sufficient evidence and supported by proper risk analysis. ACN noted
that the information should be specific to the Model 767 fleet and
should justify such a drastic increase in the frequency of the
repetitive inspection interval.
    We agree to provide justification. Operators have reported finding
chafing of the fuel pump wire bundle before the accumulation of 30,000
flight cycles or 60,000 flight hours. Wire bundle chafing could wear
away the sleeving, jacket, and wire installation, in addition to
exposing metal conductors and causing electrical arcing. Based on these
reports, the design approval holder (DAH) recommended that the wiring
inspection required by this proposed AD be done within 15,000 flight
hours after doing the most recent inspection. The DAH also recommended
not including flight cycles in the inspection interval. We analyzed
their recommendations and agreed. The repetitive interval for the
wiring inspection is within 15,000 flight hours after the most recent
inspection until the terminating action has been done. We have not
changed the second SNPRM in this regard.

Request To Correct Certain Paragraph Identifiers

    United Airlines (UAL), Japan Airlines (JAL), and UPS asked that the
paragraph identifiers referenced within certain paragraphs in the first
SNPRM (77 FR 39188, July 2, 2012) be corrected. UAL, JAL, and UPS
stated that those paragraph identifiers are incorrect and suggested
changes. The suggested changes to the first SNPRM are as follows:
     The reference within paragraph (i)(2)(i)(C) that
identifies paragraph (h)(2)(i)(D) should identify paragraph
(i)(2)(i)(D).
     The reference within paragraph (i)(2)(i)(D) that
identifies paragraph (h)(2) should identify paragraph (i)(2).
     The reference within paragraph (k) that identifies
paragraph (l)(1) or (l)(2) should identify paragraph (k)(1) or (k)(2).
    We agree with the commenters' requests for the reasons provided. We
have changed those paragraphs identified above accordingly.

Request To Clarify Terminating Action

    JAL asked that paragraph (g) be added to paragraph (l) of the first
SNPRM (77 FR 39188, July 2, 2012), so that accomplishing the
terminating action specified in Boeing Alert Service Bulletin 767-
28A0104, Revision 1, dated March 2, 2012, applies to paragraphs (g) and
(k) of the first SNPRM. JAL also asked that Boeing Alert Service
Bulletin 767-28A0104, Revision 1, dated March 2, 2012, be added to
paragraph (m) of the first SNPRM.
    We agree to clarify the terminating action. We have changed the
last sentence of paragraph (l) of this second SNPRM to read:
``Accomplishing the replacement specified in this paragraph ends the
repetitive inspection requirements in paragraphs (g) and (k) of this
AD.'' However, we have not changed paragraph (m) of this second SNPRM
in this regard, because that paragraph gives credit for accomplishing
the terminating action required by paragraph (l) of this second SNPRM,
if the terminating action was done before the effective date of the AD
using Boeing Alert Service Bulletin 767-28A0104, dated January 25,
2011.

Request To Reference Certain AD Paragraph

    UAL stated that it reviewed Boeing Service Bulletin 767-28A0053,
Revision 3, dated November 11, 2011, which contains a note that refers
to paragraph (c)(2)(ii) of AD 2000-11-06, Amendment 39-11754 (65 FR
34928, June 1, 2000; corrected August 1, 2000 (65 FR 46862)). UAL
suggested that the first SNPRM (77 FR 39188, July 2, 2012), provide
information regarding the applicable equivalent paragraph in the
superseding AD.
    We acknowledge that Boeing Service Bulletin 767-28A0053, Revision
3, dated November 11, 2011, refers to paragraph (c)(2)(ii) of AD 2000-
11-06, Amendment 39-11754 (65 FR 34928, June 1, 2000; corrected August
1, 2000 (65 FR 46862)). Paragraph (c)(2)(ii) of AD 2000-11-06
corresponds to paragraph (i)(2)(ii) of this second SNPRM. However, we
do not agree with requiring a service information update, because the
note which refers to paragraph (c)(2)(ii) of that service information
will not adversely affect accomplishment of the required actions. We
have not changed the second SNPRM in this regard.

Request To Clarify Certain Language in the ``Comments'' Section of the
First SNPRM (77 FR 39188, July 2, 2012)

    Boeing asked that the language in the ``Comments'' section of the
preamble of

the first SNPRM (77 FR 39188, July 2, 2012), which refers to Boeing
Alert Service Bulletin 767-28A0104, Revision 1, dated March 2, 2012,
including procedures for a wiring change, be clarified. Boeing stated
that the language should emphasize that the procedures include the
addition of a conduit liner and new wire bundle.
    We acknowledge and agree with the commenter's request for
clarification; however, the content of that section of the preamble of
the first SNPRM (77 FR 39188, July 2, 2012) does not reappear in this
second SNPRM. However, we have added the words ``with a conduit liner''
to paragraph (l) of this second SNPRM for clarification.

Request To Clarify Service Information

    UAL requested that we reference new service information to address
minor corrections for Boeing Alert Service Bulletin 767-28A0104,
Revision 1, dated March 2, 2012. UAL noted that certain figure callouts
should be revised.
    We do not agree. Boeing has not yet issued a revised service
bulletin. Accomplishing Boeing Alert Service Bulletin 767-28A0104,
Revision 1, dated March 2, 2012, addresses the identified unsafe
condition. If a new service bulletin is issued later, operators may
request an alternative method of compliance (AMOC) in accordance with
the procedures specified in paragraph (p) of this AD. We have not
changed the second SNPRM in this regard.

Request to Increase Work-Hours

    UAL asked that the work-hours specified in the ``Costs of
Compliance'' section of the first SNPRM (77 FR 39188, July 2, 2012) be
increased. UAL stated that the new proposed action in the first SNPRM
specifies that it will take 33 work-hours per airplane; however, Boeing
Alert Service Bulletin 767-28A0104, Revision 1, dated March 2, 2012,
specifies 41.5 work-hours per airplane. UAL suggested increasing the
work-hours to be consistent with the service information.
    We agree with the commenter. The cost data that was included in the
first SNPRM (77 FR 39188, July 2, 2012) has been updated. We have
changed the total number of work-hours for the ``new proposed action''
in the ``Costs of Compliance'' section of this second SNPRM
accordingly.

FAA's Determination

    We are proposing this second supplemental NPRM because we evaluated
all the relevant information and determined the unsafe condition
described previously is likely to exist or develop in other products of
the same type design. Certain changes described above expand the scope
of the first SNPRM (77 FR 39188, July 2, 2012). As a result, we have
determined that it is necessary to reopen the comment period to provide
additional opportunity for the public to comment on this second SNPRM.

Proposed Requirements of the Second SNPRM

    This second SNPRM would require repetitive inspections to detect
discrepancies of the wiring and surrounding Teflon sleeves of the fuel
tank boost pumps and override/jettison pumps; replacement of the
sleeves with new sleeves, for certain airplanes; and repair or
replacement of the wiring and sleeves with new parts, as necessary; a
terminating action for the repetitive inspections, to eliminate wire
damage. This second SNPRM also would require revising the maintenance
program to incorporate changes to the airworthiness limitations
section.

Costs of Compliance

    We estimate that this proposed AD affects 414 airplanes of U.S.
registry.
    We estimate the following costs to comply with this proposed AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost on U.S.
             Action                  Labor cost           Parts cost       Cost per product        operators
----------------------------------------------------------------------------------------------------------------
Actions for airplanes with       7 work-hours x $85  None...............  $595 per            Up to $246,330 per
 jettison pumps, required by AD   per hour = $595                          inspection cycle.   inspection cycle.
 2000-11-06, Amendment 39-11754   per inspection
 (65 FR 34928, June 1, 2000;      cycle.
 corrected August 1, 2000 (65
 FR 46862)).
Actions for airplanes without    5 work-hours x $85  None...............  $425 per            Up to $175,950 per
 jettison pumps, required by AD   per hour = $425                          inspection cycle.   inspection cycle.
 2000-11-06 Amendment 39-11754    per inspection
 (65 FR 34928, June 1, 2000;      cycle.
 corrected August 1, 2000 (65
 FR 46862)).
New proposed action: Replace     42 work[dash]hours  $6,061.............  $9,631............  $3,987,234.
 existing wire bundles with new   x $85 per hour =
 wire bundles.                    $3,570.
New proposed revision to         1 work-hour x $85   None...............  $85...............  $35,190.
 maintenance program.             per hour = $85.
----------------------------------------------------------------------------------------------------------------

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

                                               On-Condition Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per
                    Action                                Labor cost               Parts cost        product
----------------------------------------------------------------------------------------------------------------
Replace wire bundle sleeves if damage found    1 work hour x $85 per hour =             $1,452          $1,537.
 during inspections.                            $85.
----------------------------------------------------------------------------------------------------------------

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, Section 106, describes the
authority of the FAA Administrator. Subtitle VII, Aviation Programs,
describes in more detail the scope of the Agency's authority.
    We are issuing this rulemaking under the authority described in
Subtitle VII,

Part A, Subpart III, Section 44701, ``General requirements.'' Under
that section, Congress charges the FAA with promoting safe flight of
civil aircraft in air commerce by prescribing regulations for
practices, methods, and procedures the Administrator finds necessary
for safety in air commerce. This regulation is within the scope of that
authority because it addresses an unsafe condition that is likely to
exist or develop on products identified in this rulemaking action.

Regulatory Findings

    We determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect on the States, on the relationship
between the national Government and the States, or on the distribution
of power and responsibilities among the various levels of government.
    For the reasons discussed above, I certify this proposed
regulation:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979),
    (3) Will not affect intrastate aviation in Alaska, and
    (4) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

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

The Proposed Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by removing airworthiness directive (AD)
2000-11-06, Amendment 39-11754 (65 FR 34928, June 1, 2000; corrected
August 1, 2000 (65 FR 46862)), and adding the following new AD:

The Boeing Company: Docket No. FAA-2010-1160; Directorate Identifier
2010-NM-148-AD.

(a) Comments Due Date

    The FAA must receive comments on this AD action by April 22,
2013.

(b) Affected ADs

    This AD supersedes AD 2000-11-06, Amendment 39-11754 (65 FR
34928, June 1, 2000; corrected August 1, 2000 (65 FR 46862)).

(c) Applicability

    (1) This AD applies to The Boeing Company Model 767-200, -300, -
300F, and -400ER series airplanes, certificated in any category, as
identified in Boeing Service Bulletin 767-28A0053, Revision 3, dated
November 11, 2011.
    (2) This AD requires revisions to certain operator maintenance
documents to include new actions (e.g., inspections) and/or Critical
Design Configuration Control Limitations (CDCCLs). Compliance with
these actions and/or CDCCLs is required by 14 CFR 91.403(c). For
airplanes that have been previously modified, altered, or repaired
in the areas addressed by this AD, the operator may not be able to
accomplish the actions described in the revisions. In this
situation, to comply with 14 CFR 91.403(c), the operator must
request approval for an alternative method of compliance according
to paragraph (p) of this AD. The request should include a
description of changes to the required actions that will ensure the
continued operational safety of the airplane.

(d) Subject

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

(e) Unsafe Condition

    This AD was prompted by fleet information indicating that the
repetitive inspection interval in the existing AD is too long
because excessive chafing of the sleeving continues to occur much
earlier than expected between scheduled inspections. We are issuing
this AD to detect and correct chafing of the fuel pump wire
insulation and consequent exposure of the electrical conductor,
which could result in electrical arcing between the wires and
conduit and consequent fire or explosion of the fuel tank.

(f) Compliance

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

(g) Retained Repetitive Inspections

    This paragraph restates the requirements of paragraph (a) of AD
2000-11-06, Amendment 39-11754 (65 FR 34928, June 1, 2000; corrected
August 1, 2000 (65 FR 46862)), with revised service information.
Perform a detailed visual inspection to detect discrepancies--
including the presence of cuts, splits, holes, worn areas, and
lacing ties installed on the outside of the sleeves (except at the
sleeve ends)--of the Teflon sleeves surrounding the wiring of the
fuel tank boost pumps and override/jettison pumps, at the earlier of
the times specified in paragraphs (g)(1) and (g)(2) of this AD, in
accordance with Boeing Service Bulletin 767-28A0053, Revision 1,
dated August 5, 1999; Boeing Alert Service Bulletin 767-28A0053,
Revision 2, dated June 24, 2010; or Boeing Service Bulletin 767-
28A0053, Revision 3, dated November 11, 2011. Repeat the inspection
thereafter at intervals not to exceed 60,000 flight hours or 30,000
flight cycles, whichever occurs first. As of the effective date of
this AD, only Boeing Service Bulletin 767-28A0053, Revision 3, dated
November 11, 2011, may be used to do the actions required by this
paragraph.
    (1) Prior to the accumulation of 50,000 total flight hours, or
within 90 days after July 6, 2000 (the effective date of AD 2000-11-
06, Amendment 39-11754 (65 FR 34928, June 1, 2000; corrected August
1, 2000 (65 FR 46862)), whichever occurs later.
    (2) Within 18 months after July 6, 2000 (the effective date of
AD 2000-11-06, Amendment 39-11754 (65 FR 34928, June 1, 2000;
corrected August 1, 2000 (65 FR 46862)).

(h) Retained Corrective Actions

    This paragraph restates the requirements of paragraph (b) of AD
2000-11-06, Amendment 39-11754 (65 FR 34928, June 1, 2000; corrected
August 1, 2000 (65 FR 46862)), with revised service information. If
any discrepancy is detected during any inspection required by
paragraph (g) of this AD: Prior to further flight, remove the Teflon
sleeves and perform a detailed visual inspection to detect damage of
the wiring, in accordance with the Accomplishment Instructions of
Boeing Service Bulletin 767-28A0053, Revision 1, dated August 5,
1999; Boeing Alert Service Bulletin 767-28A0053, Revision 2, dated
June 24, 2010; or Boeing Service Bulletin 767-28A0053, Revision 3,
dated November 11, 2011. As of the effective date of this AD, only
Boeing Service Bulletin 767-28A0053, Revision 3, dated November 11,
2011, may be used to do the actions required by this paragraph.
    (1) If no damage to the wiring is detected, prior to further
flight, install new Teflon sleeves, in accordance with the
Accomplishment Instructions of Boeing Service Bulletin 767-28A0053,
Revision 1, dated August 5, 1999; Boeing Alert Service Bulletin 767-
28A0053, Revision 2, dated June 24, 2010; or Boeing Service Bulletin
767-28A0053, Revision 3, dated November 11, 2011. As of the
effective date of this AD, only Boeing Service Bulletin 767-28A0053,
Revision 3, dated November 11, 2011, may be used to do the actions
required by this paragraph.
    (2) If any damage to the wiring is detected, prior to further
flight, accomplish the requirements of paragraph (i) of this AD.

(i) Retained Corrective Actions

    This paragraph restates the requirements of paragraph (c) of AD
2000-11-06, Amendment 39-11754 (65 FR 34928, June 1, 2000; corrected
August 1, 2000 (65 FR 46862)), with revised service information. If
any damage to the wiring is detected during any inspection required
by paragraph (h) of this AD: Prior to further flight, perform a
detailed visual inspection to determine if the wiring damage was
caused by arcing, in accordance with the Accomplishment Instructions
of Boeing Service Bulletin 767-

28A0053, Revision 1, dated August 5, 1999; Boeing Alert Service
Bulletin 767-28A0053, Revision 2, dated June 24, 2010; or Boeing
Service Bulletin 767-28A0053, Revision 3, dated November 11, 2011.
As of the effective date of this AD, only Boeing Service Bulletin
767-28A0053, Revision 3, dated November 11, 2011, may be used to do
the actions required by this paragraph.
    (1) If the wire damage was not caused by arcing: Prior to
further flight, repair any damaged wires or replace the wires with
new or serviceable wires, as applicable, and install new Teflon
sleeves, in accordance with the Accomplishment Instructions of
Boeing Service Bulletin 767-28A0053, Revision 1, dated August 5,
1999; Boeing Alert Service Bulletin 767-28A0053, Revision 2, dated
June 24, 2010; or Boeing Service Bulletin 767-28A0053, Revision 3,
dated November 11, 2011. As of the effective date of this AD, only
Boeing Service Bulletin 767-28A0053, Revision 3, dated November 11,
2011, may be used to do the actions required by this paragraph.
    (2) If any damage caused by arcing is found: Prior to further
flight, perform an inspection for signs of fuel inside the conduit
or on the wires, in accordance with the Accomplishment Instructions
of Boeing Service Bulletin 767-28A0053, Revision 1, dated August 5,
1999; Boeing Alert Service Bulletin 767-28A0053, Revision 2, dated
June 24, 2010; or Boeing Service Bulletin 767-28A0053, Revision 3,
dated November 11, 2011. As of the effective date of this AD, only
Boeing Service Bulletin 767-28A0053, Revision 3, dated November 11,
2011, may be used to do the actions required by this paragraph.
    (i) If no sign of fuel is found, accomplish the actions
specified in paragraphs (i)(2)(i)(A), (i)(2)(i)(B), (i)(2)(i)(C),
and (i)(2)(i)(D) of this AD.
    (A) Prior to further flight, repair the wires or replace the
wires with new or serviceable wires, as applicable, in accordance
with the Accomplishment Instructions of Boeing Service Bulletin 767-
28A0053, Revision 1, dated August 5, 1999; Boeing Alert Service
Bulletin 767-28A0053, Revision 2, dated June 24, 2010; or Boeing
Service Bulletin 767-28A0053, Revision 3, dated November 11, 2011.
As of the effective date of this AD, only Boeing Service Bulletin
767-28A0053, Revision 3, dated November 11, 2011, may be used to do
the actions required by this paragraph.
    (B) Prior to further flight, install new Teflon sleeves, in
accordance with the Accomplishment Instructions of Boeing Service
Bulletin 767-28A0053, Revision 1, dated August 5, 1999; Boeing Alert
Service Bulletin 767-28A0053, Revision 2, dated June 24, 2010; or
Boeing Service Bulletin 767-28A0053, Revision 3, dated November 11,
2011. As of the effective date of this AD, only Boeing Service
Bulletin 767-28A0053, Revision 3, dated November 11, 2011, may be
used to do the actions required by this paragraph.
    (C) Repeat the inspection for signs of fuel inside the conduit
thereafter at intervals not to exceed 500 flight hours, until the
requirements of paragraph (i)(2)(i)(D) of this AD have been
accomplished. If any fuel is found inside the conduit during any
inspection required by this paragraph, prior to further flight,
replace the conduit with a new or serviceable conduit in accordance
with the Accomplishment Instructions of Boeing Service Bulletin 767-
28A0053, Revision 1, dated August 5, 1999; Boeing Alert Service
Bulletin 767-28A0053, Revision 2, dated June 24, 2010; or Boeing
Service Bulletin 767-28A0053, Revision 3, dated November 11, 2011.
Thereafter, repeat the inspection specified in paragraph (g) of this
AD at intervals not to exceed 60,000 flight hours or 30,000 flight
cycles, whichever occurs first. As of the effective date of this AD,
only Boeing Service Bulletin 767-28A0053, Revision 3, dated November
11, 2011, may be used to do the actions required by this paragraph.
    (D) Within 6,000 flight hours or 18 months after the initial
fuel inspection specified by paragraph (i)(2) of this AD, whichever
occurs first, replace the conduit with a new or serviceable conduit,
in accordance with the Accomplishment Instructions of Boeing Service
Bulletin 767-28A0053, Revision 1, dated August 5, 1999; Boeing Alert
Service Bulletin 767-28A0053, Revision 2, dated June 24, 2010; or
Boeing Service Bulletin 767-28A0053, Revision 3, dated November 11,
2011. Such conduit replacement constitutes terminating action for
the repetitive fuel inspections required by paragraph (i)(2)(i)(C)
of this AD. As of the effective date of this AD, only Boeing Service
Bulletin 767-28A0053, Revision 3, dated November 11, 2011, may be
used to do the actions required by this paragraph.
    (ii) If any fuel is found in the conduit or on any wire: Prior
to further flight, replace the conduit with a new or serviceable
conduit, replace damaged wires with new or serviceable wires, and
install new Teflon sleeves; in accordance with the Accomplishment
Instructions of Boeing Service Bulletin 767-28A0053, Revision 1,
dated August 5, 1999; Boeing Alert Service Bulletin 767-28A0053,
Revision 2, dated June 24, 2010; or Boeing Service Bulletin 767-
28A0053, Revision 3, dated November 11, 2011. Thereafter, repeat the
inspection specified in paragraph (g) of this AD at intervals not to
exceed 60,000 flight hours or 30,000 flight cycles, whichever occurs
first. As of the effective date of this AD, only Boeing Service
Bulletin 767-28A0053, Revision 3, dated November 11, 2011, may be
used to do the actions required by this paragraph.

(j) Retained Pump Retest

    This paragraph restates the requirements of paragraph (d) of AD
2000-11-06, Amendment 39-11754 (65 FR 34928, June 1, 2000; corrected
August 1, 2000 (65 FR 46862)), with revised service information. For
any wire bundle removed and reinstalled during any inspection
required by this AD: Prior to further flight after such
reinstallation, retest the fuel pump in accordance with the
Accomplishment Instructions of Boeing Service Bulletin 767-28A0053,
Revision 1, dated August 5, 1999; Boeing Alert Service Bulletin 767-
28A0053, Revision 2, dated June 24, 2010; or Boeing Service Bulletin
767-28A0053, Revision 3, dated November 11, 2011. As of the
effective date of this AD, only Boeing Service Bulletin 767-28A0053,
Revision 3, dated November 11, 2011, may be used to do the actions
required by this paragraph.

(k) New Repetitive Inspections With Reduced Inspection Intervals

    Do the inspection required by paragraph (g) of this AD at the
time specified in paragraph (k)(1) or (k)(2) of this AD, as
applicable, in accordance with the Accomplishment Instructions of
Boeing Service Bulletin 767-28A0053, Revision 3, dated November 11,
2011. Repeat the inspection thereafter at intervals not to exceed
15,000 flight hours. Accomplishing the first inspection in this
paragraph ends the repetitive inspection requirements in paragraph
(g) of this AD.
    (1) For airplanes on which the inspection required by paragraph
(g) of this AD has been done as of the effective date of this AD: Do
the inspection within 15,000 flight hours after the most recent
inspection or within 6,000 flight hours after the effective date of
this AD, whichever occurs later, but not to exceed 60,000 flight
hours after the most recent inspection required by paragraph (g) of
this AD.
    (2) For airplanes on which the inspection required by paragraph
(g) of this AD has not been done as of the effective date of this
AD: Do the inspection before the accumulation of 15,000 total flight
hours or within 6,000 flight hours after the effective date of this
AD, whichever occurs later.

(l) New Terminating Action

    Within 60 months after the effective date of this AD: Replace
the fuel boost pump and override/jettison pump wire bundles inside
the in-tank electrical conduit with a conduit liner and new wire
bundles, in accordance with the Accomplishment Instructions of
Boeing Alert Service Bulletin 767-28A0104, Revision 1, dated March
2, 2012. Accomplishing the replacement specified in this paragraph
ends the repetitive inspection requirements in paragraphs (g) and
(k) of this AD.

(m) Credit for Previous Actions

    This paragraph provides credit for the actions required by
paragraph (l) of this AD, if those actions were performed before the
effective date of this AD using Boeing Alert Service Bulletin 767-
28A0104, dated January 25, 2011.

(n) New Maintenance Program Revision

    Within 180 days after the effective date of this AD: Revise the
maintenance program to incorporate CDCCL Task 28-AWL-29, ``In-Tank
AC Fuel Pump Wire Bundles With Protective Liner;'' and CDCCL Task
28-AWL-30, ``Fuel Boost Pump Wires in Conduit Installation--In Fuel
Tank;'' of Section 9, of Boeing 767 Airworthiness Limitations (AWLs)
and Certification Maintenance Requirements (CMRs), of the Boeing 767
Maintenance Planning Data (MPD) Document, D622T001-9, Revision
October 2012.

(o) No Alternative Actions, Intervals, and/or CDCCLs

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

(p) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Seattle Aircraft Certification Office (ACO),
FAA, has the authority to approve AMOCs for this AD, if requested
using the procedures found in 14 CFR 39.19. In accordance with 14
CFR 39.19, send your request to your principal inspector or local
Flight Standards District Office, as appropriate. If sending
information directly to the manager of the ACO, send it to the
attention of the person identified in the Related Information
section of this AD. Information may be emailed to<EMAIL_ADDRESS>    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.
    (3) AMOCs approved previously in accordance with AD 2000-11-06,
Amendment 39-11754 (65 FR 34928, June 1, 2000; corrected August 1,
2000 (65 FR 46862)), are approved as AMOCs with the corresponding
requirements of this AD. Compliance time extensions approved
previously in accordance with AD 2000-11-06 are not approved as
AMOCs for the compliance times required by paragraph (k) of this AD.

(q) Related Information

    (1) For more information about this AD, contact Rebel Nichols,
Aerospace Engineer, Propulsion Branch, ANM-140S, FAA, Seattle
Aircraft Certification Office, 1601 Lind Avenue SW., Renton,
Washington 98057-3356; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>;
email<EMAIL_ADDRESS>    (2) For service information identified in this AD, contact
Boeing Commercial Airplanes, Attention: Data & Services Management,
P.O. Box 3707, MC 2H-65, Seattle, Washington 98124-2207; telephone
206-544-5000, extension 1; fax<PHONE_NUMBER>; Internet https://www.myboeingfleet.com. You may review copies of the referenced
service information at the FAA, Transport Airplane Directorate, 1601
Lind Avenue SW., Renton, Washington. For information on the
availability of this material at the FAA, call<PHONE_NUMBER>.

    Issued in Renton, Washington, February 26, 2013.
Ali Bahrami,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2013-05295 Filed 3-7-13; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 81, Number 205 (Monday, October 24, 2016)]
[Notices]
[Pages 73113-73115]
[FR Doc No: 2016-25659]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3180-N4]

Food and Drug Administration

[Docket No. FDA-2010-N-0308]

Program for Parallel Review of Medical Devices

AGENCY: Food and Drug Administration; Centers for Medicare & Medicaid
Services, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) and the Centers for
Medicare & Medicaid Services (CMS) (the Agencies) are informing the
public that the Parallel Review of medical devices pilot program will
be fully implemented and extended indefinitely. The Agencies are
soliciting nominations from manufacturers of innovative medical devices
to participate in the ``Program for Parallel Review of Medical
Devices.'' The Parallel Review program is a collaborative effort that
is intended to reduce the time between FDA marketing approval or FDA's
granting of a de novo request and Medicare coverage decisions through
CMS's National Coverage Determination (NCD)

process. This program is intended to ensure prompt and efficient
patient access to safe and effective and appropriate medical devices
for the Medicare population.

DATES: The program described in this document for parallel review for
medical devices is effective October 24, 2016. The program will be
fully implemented as of the date of the publication of this document in
the Federal Register.

FOR FURTHER INFORMATION CONTACT: For device manufacturers interested in
Parallel Review and for general questions: Murray Sheldon, Center for
Devices and Radiological Health, Food and Drug Administration, 301-796-
5443<EMAIL_ADDRESS>For questions related to devices
reviewed by Center for Biologics Evaluation and Research: Stephen
Ripley, Center for Biologics Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver
Spring, MD 20993,<PHONE_NUMBER>. For general questions about the NCD
process: Tamara Syrek Jensen, Centers for Medicare and Medicaid
Services,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

A. Parallel Review Pilot Program's History

    As discussed in the September 17, 2010, Federal Register notice (75
FR 57045), the Agencies announced their intention to initiate a
Parallel Review pilot program that would establish a process for
overlapping evaluation of clinical evidence for premarket, FDA-
regulated medical devices in order to reduce the time between FDA
marketing approval or FDA's granting of a de novo request and a
Medicare NCD. The Agencies piloted the program in an effort to increase
quality of patient health care by facilitating earlier access to
innovative medical technologies for Medicare beneficiaries.
    In the October 11, 2011, Federal Register notice (76 FR 62808), the
Agencies provided notice of the procedures for voluntary participation
in the pilot program as well as the guiding principles they intended to
follow during the program. In the December 18, 2013, Federal Register
notice (78 FR 76628), the Agencies extended the duration of the pilot
program for an additional 2 years.
    Currently, the Agencies appreciate the full potential of the
parallel review program and realize the positive impact of the pilot,
and have now decided to transition into a permanent program.

B. Purpose of Parallel Review

    Parallel Review allows both Agencies to review information about a
medical device concurrently, rather than sequentially, while continuing
to make their premarket review and coverage decisions consistent with
their respective statutory authority. FDA works to ensure that only
safe and effective medical devices are marketed in the United States.
CMS makes coverage decisions for medical technologies, which are
reasonable and necessary for the Medicare population. Neither FDA's
premarket review criteria nor CMS's coverage processes criteria change
when a medical device is accepted into the parallel review program.

C. Lessons Learned From the Parallel Review Pilot Program

    The Agencies learned two primary lessons from the Parallel Review
pilot program. First, they found that manufacturers benefit from
engaging both Agencies at the pivotal clinical trial design phase. The
feedback that manufacturers receive from both Agencies at the pivotal
clinical trial design stage can assist manufacturers in designing
pivotal trials that can answer both Agencies' evidentiary questions.
Thus, it is more likely that manufacturers will only need to conduct a
single pivotal clinical study rather than several pivotal clinical
studies to satisfy both Agencies.
    Second, concurrent review by the Agencies of clinical evidence can
reduce the time from FDA premarket approval or the granting of a de
novo request to an NCD. For example, on August 11, 2014, FDA approved a
medical device that was part of the Parallel Review Pilot Program. On
the same day, CMS initiated its national coverage analysis (NCA). CMS
published a favorable final NCD on October 9, 2014, less than 2 months
after the medical device received its premarket approval and 7 months
before the NCD statutory due date.

II. Parallel Review Program

    Based on the positive experience from the Parallel Review Pilot
Program, both Agencies have decided to extend the Parallel Review
program indefinitely.

A. Parallel Review Process

    The program has two stages: (1) The pivotal clinical trial design
development stage, and (2) the concurrent evidentiary review stage. The
manufacturer should submit a request for parallel review prior to the
start of the first stage by sending an email to<EMAIL_ADDRESS>which indicates their interest in the program and
includes the following information:
    1. Nomination of manufacturer:
     Name of the manufacturer and relevant contact information;
     name of the product;
     succinct description of the technology and disease or
condition the device is intended to diagnose or treat; and
     state of development of the technology (that is, in pre-
clinical testing, in clinical trials, currently undergoing premarket
review by FDA)
    2. A statement that the manufacturer intends to meet jointly with
FDA and CMS using FDA's Pre-Submission program (Ref. 1), or other
mechanisms that allow for meetings of the three parties to gather and
incorporate feedback from both Agencies about the design and analysis
of their pivotal clinical trial, to support a marketing application and
a National Coverage Determination.
    3. A statement that the medical device will require an original or
supplemental application for premarket approval (PMA) or the granting
of an FDA de novo request;
    4. The medical device is not excluded by statute from Part A and/or
Part B Medicare coverage (and the request for parallel review includes
a list of Part A and/or Part B Medicare benefit categories, as
applicable, into which the manufacturer believes the medical device
falls); and
    5. A statement that the medical device addresses the public health
needs of the Medicare population (and the request for parallel review
includes an explanation of how).
    Upon completion of the pivotal trial and submission of an original
or supplemental PMA, or a de novo request, the Agencies intend to
review the pivotal clinical trial evidence concurrently (``in
parallel''). Both Agencies will independently review the data to
determine whether it meets their respective Agency's standards and
communicate with the manufacturer during their respective reviews.
    Manufacturers and each Agency have the option to withdraw from the
Parallel Review Program until CMS opens the NCD by posting a tracking
sheet. For example, if the manufacturer would like to withdraw from the
program after the pivotal trial, but before the NCA tracking sheet is
posted, that would be acceptable. More information on the NCD process
is set forth in the August 7, 2013 Federal Register notice (78 FR
48164). Once a tracking sheet is posted, CMS must complete the
statutorily defined NCD process.

B. Candidate Prioritization

    The Agencies intend to review Parallel Review requests and respond
within 30 days after receipt of the email. The Agencies intend to
prioritize innovative medical devices that will benefit from the
efficiencies of the Parallel Review. Priority will also be given to
medical devices expected to have the most impact on the Medicare
population. An FDA marketing approval does not guarantee a favorable
coverage decision.

III. Paperwork Reduction Act of 1995

    As stated in previous Federal Register notices related to the
Parallel Review pilot, due to FDA and CMS resource issues, the
permanent program will follow the same capacity limit by accepting no
more than five candidates per year. As such, like the pilot program,
this collection of information does not meet the definition of an
information collection, as defined under 44 U.S.C. 3501-3520.

IV. References

    The following references are on display in the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, and are available for viewing by
interested persons between 9 a.m. and 4 p.m., Monday through Friday;
they are also available electronically at http://www.regulations.gov.
FDA has verified the Web site addresses, as of the date this document
publishes in the Federal Register, but Web sites are subject to change
over time.

    1. FDA Guidance, ``Requests for Feedback on Medical Device
Submissions: The Pre-Submission Program and Meetings with Food and
Drug Administration Staff.'' Available at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM311176.pdf.

    Dated: October 18, 2016.
Leslie Kux,
Associate Commissioner for Policy, Food and Drug Administration.
    Dated: October 5, 2016.
Andy Slavitt,
Acting Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2016-25659 Filed 10-21-16; 8:45 am]
 BILLING CODE 4164-01-P