[Federal Register Volume 80, Number 179 (Wednesday, September 16, 2015)]
[Rules and Regulations]
[Pages 55527-55535]
[FR Doc No: 2015-23117]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2014-0194; Directorate Identifier 2014-NM-022-AD;
Amendment 39-18266; AD 2015-19-03]
RIN 2120-AA64

Airworthiness Directives; The Boeing Company Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: We are adopting a new airworthiness directive (AD) for all The
Boeing Company Model 737-600, -700, -700C, -800, -900, and -900ER
series airplanes. This AD was prompted by reports of latently failed
fuel shutoff valves discovered during fuel filter replacement. This AD
requires revising the maintenance or inspection program to include new
airworthiness limitations. We are issuing this AD to detect and correct
latent failures of the fuel shutoff valve to the engine, which

could result in the inability to shut off fuel to the engine and, in
case of certain engine fires, an uncontrollable fire that could lead to
wing failure.

DATES: This AD is effective October 21, 2015.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2014-
0194; 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 address for the Docket Office (phone: 800-647-
5527) is Docket 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: Rebel Nichols, Aerospace Engineer,
Propulsion Branch, ANM-140S, FAA, Seattle Aircraft Certification
Office, 1601 Lind Avenue SW., Renton, WA 98057-3356; phone: 425-917-
6509; 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 The Boeing Company
Model 737-600, -700, -700C, -800, -900, and -900ER series airplanes.
The NPRM published in the Federal Register on April 14, 2014 (79 FR
20834). The NPRM was prompted by reports of latently failed fuel
shutoff valves discovered during fuel filter replacement. The NPRM
proposed to require revising the maintenance or inspection program to
include new airworthiness limitations. We are issuing this AD to detect
and correct latent failures of the fuel shutoff valve to the engine,
which could result in the inability to shut off fuel to the engine and,
in case of certain engine fires, an uncontrollable fire that could lead
to wing failure.

Record of Ex Parte Communication

    In preparation of AD actions such as NPRMs and immediately adopted
rules, it is the practice of the FAA to obtain technical information
and information on operational and economic impacts from design
approval holders and aircraft operators. We discussed certain comments
addressed in this final rule in a teleconference with Airlines for
America (A4A) and other members of the aviation industry. All of the
comments discussed during this teleconference are addressed in this
final rule in response to comments submitted by other commenters. A
discussion of this contact can be found in the rulemaking docket at
http://www.regulations.gov by searching for and locating Docket No.
FAA-2014-0194.

Clarification of Certain Terminology

    Throughout the preamble of this final rule, commenters may have
used the terms ``fuel shutoff valve'' and ``fuel spar valve''
interchangeably. Both terms refer to the same part. In our responses to
comments, we have used the term ``fuel shutoff valve.'' The term ``fuel
spar valve'' is more commonly used in airplane maintenance
documentation and, therefore, we have used that term in figure 1 to
paragraph (g) of this AD.

Comments

    We gave the public the opportunity to participate in developing
this AD. The following presents the comments received on the NPRM (79
FR 20834, April 14, 2014) and the FAA's response to each comment.

Request To Withdraw the NPRM (79 FR 20834, April 14, 2014)

    American Airlines (AA) requested that no further regulatory action
be taken. AA stated that it has experienced only a small number of fuel
shutoff valve actuator failures. AA stated that the combination of
failures necessary to produce the catastrophic event described in the
NPRM (79 FR 20834, April 14, 2014) includes fuel shutoff valve actuator
failure, an erroneous position indication, and a fire in the engine
compartment. AA also stated that risk analysis shows the probability of
this combination occurring is in the improbable range of ``10E-11 to
10E-16.''
    We disagree with commenter's request. We have determined that an
unsafe condition exists that warrants an interim action until the
manufacturer finishes developing a modification that will address the
identified unsafe condition. We have determined that, without the
required interim action, a significant number of flights with a fuel
shutoff valve actuator that is failed in the open valve position will
occur during the affected fleet life. If certain engine fire conditions
were to occur, or if extreme engine damage were to occur, or if an
engine separation event were to occur during flight, the crew
procedures for such an event would not stop the fuel flow to the engine
strut and nacelle. The continued flow of fuel could cause an
uncontrolled fire or lead to a fuel exhaustion event.
    The FAA regulations require all transport airplanes to be fail safe
with respect to engine fire events, and the risk due to severe engine
damage events to be minimized. Therefore, we require, for each flight,
sufficiently operative fire safety systems so that fires can be
detected and contained, and that fuel to the engine strut and nacelle
can be shut off in the event of an engine fire or severe damage.
    The FAA airworthiness standards require remotely controlled
powerplant valves to provide indications that the valves are in the
commanded position. These indications allow the prompt detection and
correction of valve failures. We do not allow dispatch with a known
inoperative fuel shutoff valve. Therefore, we are proceeding with this
final rule--not because of the higher-than-typical failure rate of the
particular valve actuator involved, but instead because the fuel
shutoff valve actuator can fail in a manner that also defeats the
required valve position indication feature. That failure can lead to a
large number of flights occurring on an airplane with a fuel shutoff
valve actuator failed in the open position without the operator being
aware of the failure. An airworthiness limitation containing required
inspections is intended to limit the number of flights following latent
failure of the fuel shutoff valve. We have not changed this AD in this
regard.

Request for Inspection Relief

    AirDo, AA, All Nippon Airlines (ANA), Delta Airlines (DAL),
Southwest Airlines (SWA), Transavia, and United Airlines (UAL)
requested clarification of the daily check requirement. The commenters
stated that the check applies to airplanes that are in operational
revenue status. The commenters stated that the proposed AD (79 FR
20834, April 14, 2014) does not account for airplanes in routine
maintenance or for an out-of-service condition.
    We infer the commenters are requesting inspection relief for
airplanes that are not in service. We agree with the commenters'
request. It would be unnecessarily burdensome to require the
inspections on airplanes that are not being used. We agree with
limiting inspections to days when the airplane is in revenue service.
In the Interval column of figure 1 to paragraph (g) of this AD, we have
added a note to clarify that the operational check is not

required on days when the airplane is not used in revenue service, but
that the check must be done before further flight once the airplane is
returned to revenue service.

Request To Limit the Applicability

    UAL requested that we revise the proposed AD (79 FR 20834, April
14, 2014) to limit the applicability specified in figure 1 to paragraph
(g) of the proposed AD to airplanes with the valve actuators that have
the identified unsafe condition. UAL stated the applicability applies
to valve actuators having part number (P/N) MA30A1001. UAL stated that
the problem does not apply to other existing actuator designs, and will
not apply to future designs.
    We agree with the commenter's request. It would be unnecessarily
burdensome to require the inspections on airplanes that do not have any
of the susceptible valves installed. We have added a note to the
Applicability column in figure 1 to paragraph (g) of this AD to clarify
that the limitations apply to Model 737-600, -700, -700C, -800, -900,
and -900ER airplanes having actuator P/N MA20A2027 (Boeing P/N
S343T003-56) or P/N MA30A1001 (Boeing P/N S343T003-66) installed at the
engine fuel spar valve positions.

Request To Follow the Master Minimum Equipment List (MMEL) in Lieu of
the Daily Check

    AA and Qantas Airways stated that if the master minimum equipment
list (MMEL) is being used, then the daily check should be not required.
    AA stated that the Boeing Model 737 MMEL item 28-22, ``Fuel/Spar
Valve Closed Lights,'' allows for the lights to be inoperative,
provided the associated valve is verified to operate normally and the
crossfeed VALVE OPEN light operates normally. AA stated that this item
allows the lights to be inoperative for up to 10 days, and it requested
that a provision be added to state that if this MMEL is being used, the
daily check is not required.
    Qantas Airways stated that if an airplane is dispatched under the
MMEL for inoperative SPAR VALVE CLOSED light(s), then it is not
possible to accomplish the proposed checks.
    We partially agree with the commenters' request. We disagree with
providing MMEL relief for an inoperative fuel shutoff valve indication
because such relief could potentially allow the fuel shutoff valve to
be inoperative for up to 10 days of revenue operation. However, we do
agree to provide flexibility regarding verification that the fuel
shutoff valve is operational. We have added item D. to figure 1 to
paragraph (g) of this AD to specify a fourth option to perform daily
inspections to verify that the fuel shutoff valve is closing.

Request To Clarify Recording Requirements

    Air Do, Ryanair, SWA, Transavia, UAL, and Darryl Voss requested
that the FAA provide a more complete explanation of the requirements
with regard to recording compliance.
    Air Do stated that if the flightcrew performed the operational
check, a maintenance record is usually not created. The commenter
questioned whether this is acceptable, or whether the flightcrew should
record it in the flight log.
    Ryanair requested that the FAA explicitly state in the AD that the
proposed actions may be performed by maintenance and/or flight
operations checklists, and that the AD will not require the retention
of maintenance or flight operations records to show compliance. Ryanair
stated that due to the high frequency of the actions in the NPRM (79 FR
20834, April 14, 2014) and the large number of affected airplanes in
its fleet (approximately 300), the creation, retention, and
reforecasting of individual records for this activity is not practical.
    Because of the high frequency of checks resulting from the proposed
AD (79 FR 20834, April 14, 2014), compounded with the creation,
distribution, and retention of the documentation of the checks, SWA
requested that the FAA specifically state in the AD that when the daily
check is performed successfully by flightcrews, no documentation is
required. SWA also requested that the FAA specifically state in the AD
that documentation (i.e., logbook entry or other type of defect report)
is required only when a failure is detected by the flightcrew, or when
the check is performed by maintenance personnel.
    Transavia requested that, if the daily check remains, we revise the
proposed AD (79 FR 20834, April 14, 2014) to state that the inclusion
of the daily check requirement into a checklist is sufficient to show
AD compliance and prevent unwanted paperwork, and that the daily check
can be performed by either maintenance personnel or the flightcrew.
    UAL asked whether the flightcrews will be required to record
compliance of the operational checks and document each inspection.
Darryl Voss requested that we revise the proposed AD (79 FR 20834,
April 14, 2014) to remove the option to allow flightcrews to perform
operational checks for maintenance. Mr. Voss stated that showing
compliance with ADs is almost exclusively a maintenance function and
should remain a maintenance function to provide compliance continuity.
    We agree that clarification is necessary. This AD requires
including the information in figure 1 of paragraph (g) of this AD in
the maintenance or inspection program. However, this AD does not
require accomplishing the actions specified in figure 1 of paragraph
(g) of this AD. The actions specified in the figure in this AD are
done, and remain enforceable, as part of the airworthiness limitations
of the instructions for continued airworthiness (ICA). Section 14 CFR
43.11(a) of the Federal Aviation Regulations (14 CFR 43.11(a)) requires
maintenance record entries for maintenance actions such as the required
checks. If an operator elects to have a flightcrew member do the check
in accordance with the applicable airworthiness limitation, that same
action would be considered an operational task (not maintenance), and
therefore 14 CFR 43.11(a) would not apply. In that case, operators
should follow their normal processes for operational activities,
including necessary Principal Operations Inspector (POI) involvement.
We have not changed this AD in this regard.

Request To Clarify Inspection Procedures for Operational Checks

    Boeing requested to add a flightcrew inspection procedure during
engine start and engine shutdown. Boeing stated that this will provide
common flight procedures and eliminate each operator creating its own
test.
    DAL requested that the preamble of the NPRM (79 FR 20834, April 14,
2014) be revised to match the rest of the requirements in the NPRM. DAL
stated that if POI approval is required for flightcrews to accomplish
operational checks, then the preamble should identify that flightcrews
can only accomplish operational checks approved by the inspector. DAL
stated that the preamble should not associate the operational check
without engine start to only maintenance crews, and the operational
checks while starting the engine or shutting down the engine to only
flightcrews.
    UAL requested that standardized procedures be established by the
FAA aircraft certification office for the POI to approve on behalf of
all affected operators.
    We disagree with the commenter's request to add to this AD a method
describing how maintenance actions and operations actions should be

coordinated. The operational requirements are specified in figure 1 to
paragraph (g) of this AD; how these requirements are captured in the
operations processes to ensure that the maintenance action has been
completed is likely different for each operator. As the commenter
stated, flightcrews can only accomplish operational checks approved by
the inspector. No change has been made to the final rule in this
regard.

Request To Provide an Alternative to the Maintenance or Inspection
Program Revision in Operational Documents

    DAL requested that the proposed AD (79 FR 20834, April 14, 2014) be
revised to provide an option for revising the Boeing Model 737
``Airplane Normal Checklist'' to specify accomplishment of one of the
required operational checks (operational check during engine start,
operational check during engine shutdown, or operational check without
engine operations) as a ``FIRST FLIGHT OF THE DAY'' requirement as an
alternative to the maintenance or inspection program revision specified
in paragraph (g) of the proposed rule. DAL stated that this option
would ensure that operational aircraft are inspected daily, provide
clear responsibility to the flightcrew to accomplish the operational
checks, and remove concern for accomplishing the actions during times
when the airplane is not in service. DAL stated that incorporating this
change to the ``Airplane Normal Checklist'' will simplify compliance
procedures while satisfying the requirements of the proposed rule.
    JAL requested that the FAA coordinate with Boeing to revise the
flightcrew operations manual (FCOM) to provide the check of the fuel
spar valve as a normal procedure. JAL stated that if an operational
check by the flightcrew is allowed, the FCOM should be revised to
provide the normal procedure to perform the fuel spar valve check
during engine start or shutdown.
    Qantas Airways suggested that a revision to the Boeing Model 737
Airplane Flight Manual (AFM), Section 1 ``Certificate Limitations,'' or
Section 3 ``Normal Procedures,'' might be a more appropriate location
to allow the flightcrew to monitor valve operations during engine start
and/or engine shutdown.
    We find that clarification is necessary. Changing these documents
presupposes that every operator will have flightcrews perform this
task. It is not our intention to require flightcrews to perform this
task. Individual operators can modify their normal operating procedures
to add this requirement.

Request To Clarify the Operational Check During Engine Start

    Qantas stated that it does not believe that paragraph B. of the
Description column of figure 1 to paragraph (g) of the proposed AD (79
FR 20834, April 14, 2014), which specifies to do an operational check
during engine start, achieves the desired failure detection. Qantas
stated that if the test fails (i.e., bright light fails to illuminate),
the valve has failed to open; this is different than a valve that has
failed to close. Qantas stated that the test should identify the failed
actuator in the failure mode, which results in an unsafe condition.
    We infer that Qantas is requesting we clarify the operational check
during engine start. We find that clarification is necessary. The check
procedure is designed to make sure the fuel shutoff valve actuator
moves to the open position from the closed position. However, if the
fuel shutoff valve actuator had previously failed open, the actuator
would not move the valve and this check would fail. If this check
fails, the fuel shutoff valve actuator is either failed in the closed
position or has failed previously in the open position. Either way, the
failed fuel shutoff valve actuator must be replaced. We have not
changed this AD in this regard.

Request To Add Requirement To Provide Electrical Power Before the
Maintenance Check

    UAL requested we add a requirement to provide electrical power
before accomplishment of the maintenance check specified by the
proposed AD (79 FR 20834, April 14, 2014).
    We agree with the commenter's request because electrical power is
required. In item C.1. of figure 1 to paragraph (g) of this AD, we have
added an instruction to supply electrical power to the airplane using
standard practices when performing the operational check.

Request To Reference the Fault Isolation Manual

    Boeing requested that figure 1 to paragraph (g) of the proposed AD
(79 FR 20834, April 14, 2014) be revised in order to reference the
Fault Isolation Manual (FIM), instead of the Boeing Model 737 Aircraft
Maintenance Manual (AMM), should the operational check fail. Boeing
stated that the faults are isolated to failed components using the FIM.
The AMM provides instructions for removing and replacing identified
failed components. Boeing stated that the light could fail to
illuminate for reasons other than actuator failure.
    We disagree with the commenter's request to reference the FIM
instead of the AMM. If an operational check fails, the failed component
must be replaced. As Boeing stated, the AMM provides instructions for
replacing failed components. The FIM also refers to the AMM for
replacement of the fuel shutoff valve actuator after doing some
preliminary testing. Operators may consult the FIM for guidance in
troubleshooting other reasons the light could fail to illuminate. We
have not changed this AD in this regard.

Request To Extend the Repetitive Interval for the Operational Checks

    ANA requested that the repetitive interval be revised from daily to
15,000 flight hours or 6,000 flight hours, or a weekly interval. ANA
stated that Boeing has included these repetitive intervals in certain
maintenance documents. ANA commented that it has 38 airplanes in
operation and it has never experienced a latent failure of the MOV
actuator. ANA also stated that the possibility of the unsafe condition
happening is very low. ANA stated that a daily interval is a burden to
operators.
    DAL requested that the operational checks be required at intervals
not to exceed 90 days or 1,400 flight cycles or 1,800 flight hours; DAL
stated that this is similar to what is proposed by the original
equipment manufacturer. DAL stated that Airworthiness Limitation Task
28-AWL-MOV, ``Engine Fuel Shut-Off Valve (Fuel Spar Valve) Position
Indication Operational Check,'' which was introduced by the proposed AD
(79 FR 20834, April 14, 2014), would require daily operational checks
of the engine fuel shutoff valve. DAL stated that it finds this will be
an onerous operational requirement as it does not have maintenance
personnel in all locations where the affected airplanes are operated.
DAL stated that for this reason, it will be necessary for its
flightcrews to accomplish the operational checks in order to comply
with the daily requirement specified by the proposed AD.
    DAL also stated that the proposed AD (79 FR 20834, April 14, 2014)
does not provide significant information as to how the daily check
requirement was determined or why it differs so significantly from the
compliance recommendation established by Boeing. DAL stated that
lacking specific details of the methodology used by the FAA and the
assumptions made to arrive at a daily check interval hinders the
operator's ability to provide comments on the appropriateness of this
interval. DAL stated that Boeing has indicated that its numeric safety
analysis supports

a compliance period of 3,000 flight hours for the operational checks.
DAL also stated that based on current DAL utilization, accomplishment
of daily checks equates to accomplishing the check approximately 300
times more frequently than the interval supported by the Boeing safety
analysis.
    JAL requested that the FAA extend the inspection interval to a
heavy maintenance opportunity. For Model 737-800 airplanes, JAL stated
to set the heavy maintenance opportunity (such as ``C-Check'' and ``K-
Check'') at approximately 2-year intervals to efficiently accomplish
the maintenance program.
    Qantas Airways requested an interval that can be effectively
scheduled in aircraft maintenance control programs, such as a 7-day
interval.
    Jim Way requested a monthly interval for the operational checks.
Mr. Way stated that a daily check is too restrictive.
    Bradley Most requested that the daily inspection interval be
revised to every 2 calendar days to accommodate ``international
operations, out of station, overnight, etc.'' Mr. Most stated that the
interval of daily lacks a clear definition.
    We disagree with the requests to extend the inspection interval. An
increase in the inspection interval from daily to every other day, to
weekly, or to 90 days, would result in 2, 7, or 90 times as many
flights at risk in the event of an engine fire. The daily inspection
has been deemed practical because, in practice, it will mean the
flightcrew will need to watch a light as they start or shut down the
engine using normal procedures. An increased interval to 6,000 flight
hours would have no real effect on the unsafe condition since the fuel
filter replacement currently detects the problem every 6,000 flight
hours. In addition, an increased interval of 15,000 flight hours, or 24
months, would similarly not improve safety. We have not changed this AD
in this regard.

Request To Revise the Proposed Compliance Time for Revising the
Maintenance or Inspection Program

    Mr. Most requested that the compliance time to revise the
maintenance or inspection program be changed to 120 days after the
effective date of this AD. Mr. Most stated that FAA offices are
typically requesting 60 days to review an airplane maintenance or
inspection program revision that is submitted for approval and, in many
cases, are taking longer. Mr. Most stated that the current inspection
interval would not allow operators enough time to revise the airplane
maintenance or inspection program, submit it to FAA for approval, and
implement the revised airplane maintenance or inspection program within
30 days of the effective date.
    Jim Way requested that operators be given 90 days after the
effective date of the proposed AD (79 FR 20834, April 14, 2014) to
incorporate the actions specified in figure 1 to paragraph (g) of the
proposed AD into the maintenance program. Mr. Way stated that single
aircraft operators use a vendor to provide support for the inspection
program revisions. Mr. Way stated that a 30-day compliance time after
the effective date of the proposed AD is not enough time to properly
make and submit the changes to the FAA's principal maintenance
inspector for approval and implementation.
    We do not agree to revise the compliance time for revising the
maintenance or inspection program beyond 30 days. The 30-day compliance
time specified in paragraph (g) of this AD is consistent with other
regulatory actions for other affected models in similar ADs. However,
under the provisions of paragraph (i)(1) of this AD, we might consider
requests for adjustments to the compliance time if data are submitted
to substantiate that such an adjustment would provide an acceptable
level of safety.

Request To Change the Initial Compliance Time for the Operational Check

    AA requested that 30 days be provided for the initial operational
check after the airworthiness limitation (AWL) has been incorporated
into its maintenance program. AA stated that this will allow for
publishing the new criteria.
    We partially agree with AA's request concerning the compliance time
for the initial operational check. We have changed the initial
compliance time specified in paragraph (g) of this AD for accomplishing
the actions specified in figure 1 to paragraph (g) of this AD from 7 to
10 days. The compliance time of 10 days is consistent with other
regulatory actions for other affected models in similar ADs. We have
determined that 10 days for the initial inspection represents an
appropriate time in which the required actions can be performed in a
timely manner within the affected fleet, while still maintaining an
adequate level of safety.

Request To Clarify Who Must Accomplish the Maintenance or Inspection
Program Revision

    DAL requested that paragraph (g) of the proposed AD (79 FR 20834,
April 14, 2014) be revised because it is not clear who must accomplish
the action in this paragraph. DAL stated that operators do not control
the AWL section of the ICA and, therefore, could not comply with the
requirement. DAL stated that on Boeing Model 737NG airplanes, the AWLs
are incorporated into Section 9 of the Maintenance Planning Document
(MPD) by Boeing. DAL stated that the action in the NPRM would be one
for the original equipment manufacturer to accomplish with a revision
to the MPD, which would then be incorporated by the operators. DAL also
stated that operators have control of their continuous airworthiness
maintenance program (CAMP). DAL stated that in the NPRM, it is the
intent of the operators to incorporate the AWL into their CAMP.
    We find that clarification is necessary. The requirement in
paragraph (g) of this AD is to change the Airworthiness Limitations of
the ICA for each affected airplane. Once that change is complete,
operators will be compelled to change their maintenance program to
include the new requirements of the revised Airworthiness Limitations.
For Part 121 operators, changes to the CAMP will become necessary; but
for other operators, the maintenance program may take a different form.
We have not changed the AD in this regard.

Request To Remove Redundant Language

    DAL requested that certain language be removed from the proposed AD
(79 FR 20834, April 14, 2014) because it is redundant. DAL stated that
paragraph (h) of the proposed AD can be excluded because it states that
no alternative actions or intervals can be used unless approved as an
alternative method of compliance (AMOC) in accordance with the
procedures specified in paragraph (i)(1) of the proposed AD. (Paragraph
(i) of the proposed AD specifies the procedures and requirements for an
AMOC.)
    We disagree with the commenter's request. It is necessary to
include paragraph (h) of this AD (``No Alternative Actions or
Intervals'') because it ensures that changes made after accomplishment
of the maintenance or inspection program revision, e.g., using new
versions of the maintenance or inspection program, are done only when
approval of an AMOC is obtained from the FAA. We have not changed this
AD in this regard.

Request To Revise the Costs of Compliance Paragraph

    DAL stated that the cost estimate provided in the NPRM (79 FR
20834, April 14, 2014) is inaccurate. DAL

stated that the cost reflected in the NPRM is for incorporating the
proposed program change into the operator's program only as a revision
of the maintenance or inspection program.'' DAL stated the cost
estimate presented is flawed in two aspects: It does not properly
account for the cost operators will take on in implementing the program
changes, and it does not account for the cost of actually performing
the inspections specified by the proposed maintenance or inspection
program changes.
    We infer that DAL is requesting we revise the Costs of Compliance
paragraph. We acknowledge the commenter's concern. In this AD, the
required action is to revise the maintenance or inspection program, as
applicable, to include a new airworthiness limitation. The added
airworthiness limitation requires an inspection of the position of the
MOV actuator daily. However, these repetitive inspections, which are
expected to take a few seconds to complete, are required by section
91.403(c) of the Federal Aviation Regulations (14 CFR 91.403(c)) once
incorporated into the maintenance or inspection program.
    The cost analysis in AD rulemaking actions typically includes only
the costs associated with complying with the AD. In this AD, the
required action is the maintenance or inspection program revision, as
applicable, to include the new airworthiness limitation. Accomplishing
repetitive actions that are specified in the airworthiness limitation
are not directly required by this AD. The FAA, as a matter of practice,
does not include a cost estimate for these repetitive actions in an AD
because these actions are required as part of the operating rules.
Therefore, we have made no change to this AD in this regard.

Request To Clarify Wording for Operational Check Without Engine
Operation

    UAL requested we revise the wording of the operational check
without engine operation. UAL stated that in item C.3.a. and item
C.4.a. in the Description column of figure 1 to paragraph (g) of this
AD, either a tolerance should be added to the wording, or the word
``approximately'' should be added before the phrase ``10 seconds.''
    We agree with the commenter's request. In item C.4.a. and item
C.5.a. (which correspond to items C.3.a. and C.4.a. of the NPRM (79 FR
20834, April 14, 2014)) in the Description column of figure 1 to
paragraph (g) of this AD, we have added wording that indicates to wait
``approximately'' 10 seconds after moving the ENG 1 and ENG 2 START
LEVER on the CONTROL STAND to the IDLE position. We find that this
change will allow flexibility during the operational check, while still
maintaining an adequate level of safety.

Request To Correct Typographical Errors

    Boeing and DAL requested that we correct a typographical error in
the proposed AD (79 FR 20834, April 14, 2014). Boeing and DAL stated
that item A.1. in the Description column of figure 1 to paragraph (g)
of the proposed AD, which states to ``do all operational checks . .
.,'' the word ``all'' should be removed because the operational check
is a singular check.
    We agree with the commenters' request. We have revised item A.1. in
the Description column of figure 1 to paragraph (g) of this AD
accordingly.
    Boeing also requested that certain other typographical errors in
the proposed AD (79 FR 20834, April 14, 2014) be corrected to reduce
the possibility of confusion regarding the requirements. Boeing stated
that the Description column in figure 1 to paragraph (g) of the
proposed AD should be revised as follows:
     Step B.2. has been skipped, and needs to be renumbered.
     In step B.1.a., the text ``START LEVEL STAND'' should be
changed to ``START LEVER ON CONTROL STAND.''
     Steps C.2. and C.3. should be combined and renumbered.
     In step C.5.a., the text ``ENG @'' should be changed to
``ENG 2.''
    We disagree with the comment. The stated typographical errors for
step B.1.a., step B.2., and step C.5.a., do not exist in the regulatory
text of the NPRM (79 FR 20834, April 14, 2014), as published. We
disagree with combining steps C.2. and C.3 because the engine fire
switches represent separate actions for the aft electronic panel and
the forward overhead panel. We have not changed this AD in this regard.

Effect of Winglets on This AD

    Aviation Partners Boeing stated that the installation of winglets
per Supplemental Type Certificate (STC) ST00830SE (http://rgl.faa.gov/
Regulatory_and_Guidance_Library/rgstc.nsf/0/
3ed73703f205e3b386257e2f0064f3b1/$FILE/ST00830SE.pdf) does not affect
the accomplishment of the manufacturer's service instructions.

Conclusion

    We reviewed the relevant data, considered the comments received,
and determined that air safety and the public interest require adopting
this AD with the changes described previously and minor editorial
changes. We have determined that these minor changes:
     Are consistent with the intent that was proposed in the
NPRM (79 FR 20834, April 14, 2014) for correcting the unsafe condition;
and
     Do not add any additional burden upon the public than was
already proposed in the NPRM (79 FR 20834, April 14, 2014).
    We also determined that these changes will not increase the
economic burden on any operator or increase the scope of this AD.

Interim Action

    We consider this AD interim action. The manufacturer is currently
developing a modification that will address the unsafe condition
identified in this AD. Once this modification is developed, approved,
and available, we might consider additional rulemaking.

Costs of Compliance

    We estimate that this AD affects 1,244 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
----------------------------------------------------------------------------------------------------------------
Incorporating Airworthiness           1 work-hour x $85 per                $0              $85         $105,740
 Limitation.                           hour = $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

    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, 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):

2015-19-03 The Boeing Company: Amendment 39-18266; Docket No. FAA-
2014-0194; Directorate Identifier 2014-NM-022-AD.

(a) Effective Date

    This AD is effective October 21, 2015.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to all The Boeing Company Model 737-600, -700, -
700C, -800, -900, and -900ER series airplanes, certificated in any
category.

(d) Subject

    Joint Aircraft System Component (JASC) Code 2823, Fuel Selector/
Shutoff Valve.

(e) Unsafe Condition

    This AD was prompted by reports of latently failed fuel shutoff
valves discovered during fuel filter replacement. We are issuing
this AD to detect and correct latent failures of the fuel shutoff
valve to the engine, which could result in the inability to shut off
fuel to the engine and, in case of certain engine fires, an
uncontrollable fire that could lead to wing failure.

(f) Compliance

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

(g) Revision of Maintenance or Inspection Program

    Within 30 days after the effective date of this AD, revise the
maintenance or inspection program, as applicable, to add
airworthiness limitation number 28-AWL-MOV, ``Engine Fuel Shutoff
Valve (Fuel Spar Valve) Position Indication Operational Check,'' by
incorporating the information specified in figure 1 to paragraph (g)
of this AD into the Airworthiness Limitations Section of the
Instructions for Continued Airworthiness. The initial compliance
time for accomplishing the actions specified in 28-AWL-MOV is within
10 days after accomplishing the maintenance or inspection program
revision required by this paragraph.

      Figure 1 to Paragraph (g) of This AD--Engine Fuel Shutoff Valve (Fuel Spar Valve) Position Indication
                                                Operational Check
----------------------------------------------------------------------------------------------------------------
           AWL No.                 Task            Interval           Applicability            Description
----------------------------------------------------------------------------------------------------------------
28-AWL-MOV..................  ALI            DAILY...............  737-600, -700, -     Engine Fuel Shutoff
                                             INTERVAL NOTE: The     700C, -800, -900,    Valve (Fuel Spar Valve)
                                              operational check     and -900ER series    Position Indication
                                              is not required on    airplanes.           Operational Check.
                                              days when the        APPLICABILITY NOTE:  Concern: The fuel spar
                                              airplane is not       Only applies to      valve actuator design
                                              used in revenue       airplanes with a     can result in airplanes
                                              service. The check    fuel spar valve      operating with a failed
                                              must be done before   actuator having      fuel spar valve
                                              further flight once   part number          actuator that is not
                                              the airplane is       MA20A2027            reported. A latently
                                              returned to revenue   (S343T003-56) or     failed fuel spar valve
                                              service..             MA30A1001            actuator could prevent
                                                                    (S343T003-66)        fuel shutoff to an
                                                                    installed at the     engine. In the event of
                                                                    engine fuel spar     certain engine fires,
                                                                    valve positions..    the potential exists
                                                                                for an engine fire to
                                                                                be uncontrollable.
                                                                                Perform one of the
                                                                                following checks of the
                                                                                engine fuel spar valve
                                                                                position (unless
                                                                                checked by the
                                                                                flightcrew in a manner
                                                                                approved by the
                                                                                principal operations
                                                                                inspector):
                                                                                A. Operational Check
                                                                                during engine shutdown.
                                                                                1. Do an operational
                                                                                check of the left
                                                                                engine fuel spar valve
                                                                                actuator.
                                                                                a. As the ENG 1 START
                                                                                LEVER on the CONTROL
                                                                                STAND is moved to the
                                                                                CUTOFF position, verify
                                                                                the SPAR VALVE CLOSED
                                                                                indication light on the
                                                                                OVERHEAD PANEL for No.1
                                                                                Engine changes from OFF
                                                                                to BRIGHT then DIM.
                                                                                b. If the test fails
                                                                                (bright light fails to
                                                                                illuminate), before
                                                                                further flight, repair
                                                                                faults as required
                                                                                (refer to Boeing
                                                                                Aircraft Maintenance
                                                                                Manual (AMM) 28-22-11).

                                                                                2. Do an operational
                                                                                check of the right
                                                                                engine fuel spar valve
                                                                                actuator.
                                                                                a. As the ENG 2 START
                                                                                LEVER on the CONTROL
                                                                                STAND is moved to the
                                                                                CUTOFF position, verify
                                                                                the SPAR VALVE CLOSED
                                                                                indication light on the
                                                                                OVERHEAD PANEL for No.
                                                                                2 Engine changes from
                                                                                OFF to BRIGHT then DIM.
                                                                                b. If the test fails
                                                                                (bright light fails to
                                                                                illuminate), before
                                                                                further flight, repair
                                                                                faults as required
                                                                                (refer to Boeing AMM 28-
                                                                                22-11).
                                                                                B. Operational check
                                                                                during engine start.
                                                                                1. Do an operational
                                                                                check of the left
                                                                                engine fuel spar valve
                                                                                actuator.
                                                                                a. As the ENG 1 START
                                                                                LEVER on the CONTROL
                                                                                STAND is moved to the
                                                                                IDLE position, verify
                                                                                the SPAR VALVE CLOSED
                                                                                indication light on the
                                                                                OVERHEAD PANEL for No.
                                                                                1 Engine changes from
                                                                                DIM to BRIGHT then OFF.
                                                                                b. If the test fails
                                                                                (bright light fails to
                                                                                illuminate), before
                                                                                further flight, repair
                                                                                faults as required
                                                                                (refer to Boeing AMM 28-
                                                                                22-11).
                                                                                2. Do an operational
                                                                                check of the right
                                                                                engine fuel spar valve
                                                                                actuator.
                                                                                a. As the ENG 2 START
                                                                                LEVER on the CONTROL
                                                                                STAND is moved to the
                                                                                IDLE position, verify
                                                                                the SPAR VALVE CLOSED
                                                                                indication light on the
                                                                                OVERHEAD PANEL for No.
                                                                                2 Engine changes from
                                                                                DIM to BRIGHT then OFF.
                                                                                b. If the test fails
                                                                                (bright light fails to
                                                                                illuminate), before
                                                                                further flight, repair
                                                                                faults as required
                                                                                (refer to Boeing AMM 28-
                                                                                22-11).
                                                                                C. Operational check
                                                                                without engine
                                                                                operation.
                                                                                1. Supply electrical
                                                                                power to airplane using
                                                                                standard practices.
                                                                                2. Make sure No. 1 and
                                                                                No. 2 Engine FIRE
                                                                                switches on the Aft
                                                                                Electronic Panel are in
                                                                                the NORMAL (IN)
                                                                                position.
                                                                                3. Make sure No. 1 and
                                                                                No. 2 Engine Start
                                                                                Switches on the Forward
                                                                                Overhead Panel are in
                                                                                the OFF or AUTO
                                                                                position.
                                                                                4. Do an operational
                                                                                check to the left
                                                                                engine fuel spar valve
                                                                                actuator.
                                                                                a. Move ENG 1 START
                                                                                LEVER on the CONTROL
                                                                                STAND to the IDLE
                                                                                position and wait
                                                                                approximately 10
                                                                                seconds.
                                                                                NOTE: It is normal under
                                                                                this test condition for
                                                                                the ENG VALVE CLOSED
                                                                                indication light on the
                                                                                OVERHEAD PANEL to
                                                                                transition from DIM to
                                                                                BRIGHT and stay BRIGHT.
                                                                                b. Move ENG 1 START
                                                                                LEVER on the CONTROL
                                                                                STAND to the CUTOFF
                                                                                position.
                                                                                c. Verify the SPAR VALVE
                                                                                CLOSED indication light
                                                                                on the OVERHEAD PANEL
                                                                                for No. 1 Engine
                                                                                changes from OFF to
                                                                                BRIGHT then DIM.
                                                                                d. If the test fails
                                                                                (bright light fails to
                                                                                illuminate), before
                                                                                further flight, repair
                                                                                faults as required
                                                                                (refer to Boeing AMM 28-
                                                                                22-11).
                                                                                5. Do an operational
                                                                                check of the right
                                                                                engine fuel spar valve
                                                                                actuator.
                                                                                a. Move ENG 2 START
                                                                                LEVER on the CONTROL
                                                                                STAND to the IDLE
                                                                                position and wait
                                                                                approximately 10
                                                                                seconds.
                                                                                NOTE: It is normal under
                                                                                this test condition for
                                                                                the ENG VALVE CLOSED
                                                                                indication light on the
                                                                                OVERHEAD PANEL to
                                                                                transition from DIM to
                                                                                BRIGHT and stay BRIGHT.
                                                                                b. Move ENG 2 START
                                                                                LEVER on the CONTROL
                                                                                STAND to the CUTOFF
                                                                                position.

                                                                                c. Verify the SPAR VALVE
                                                                                CLOSED indication light
                                                                                on the OVERHEAD PANEL
                                                                                for No. 2 Engine
                                                                                changes from OFF to
                                                                                BRIGHT then DIM.
                                                                                d. If the test fails
                                                                                (bright light fails to
                                                                                illuminate), before
                                                                                further flight, repair
                                                                                faults as required
                                                                                (refer to Boeing AMM 28-
                                                                                22-11).
                                                                                D. Perform an inspection
                                                                                of the engine fuel spar
                                                                                valve actuator
                                                                                position.
                                                                                NOTE: This inspection
                                                                                may be used whenever
                                                                                the SPAR VALVE light
                                                                                does not function
                                                                                properly.
                                                                                1. Make sure the L FUEL
                                                                                CONTROL switch on the
                                                                                quadrant control stand
                                                                                is in the CUTOFF
                                                                                position.
                                                                                NOTE: It is not
                                                                                necessary to cycle the
                                                                                FUEL CONTROL switch to
                                                                                do this inspection.
                                                                                2. Inspect the left
                                                                                engine fuel spar valve
                                                                                actuator located in the
                                                                                left rear spar.
                                                                                NOTE: The left engine
                                                                                fuel spar valve
                                                                                actuator is on the left
                                                                                wing front spar
                                                                                outboard of the engine
                                                                                strut. Access is
                                                                                through access panel
                                                                                521BB on the left wing
                                                                                leading edge.
                                                                                a. Verify the manual
                                                                                override handle on the
                                                                                engine fuel spar valve
                                                                                actuator is in the
                                                                                CLOSED position.
                                                                                b. Repair or replace any
                                                                                engine fuel spar valve
                                                                                actuator that is not in
                                                                                the CLOSED position
                                                                                (refer to Boeing AMM 28-
                                                                                22-11).
                                                                                3. Make sure the R FUEL
                                                                                CONTROL switch on the
                                                                                quadrant control stand
                                                                                is in the CUTOFF
                                                                                position.
                                                                                NOTE: It is not
                                                                                necessary to cycle the
                                                                                FUEL CONTROL switch to
                                                                                do this inspection.
                                                                                4. Inspect the right
                                                                                engine fuel spar valve
                                                                                actuator located in the
                                                                                right rear spar.
                                                                                NOTE: The right engine
                                                                                fuel spar valve
                                                                                actuator is on the
                                                                                right wing front spar
                                                                                outboard of the engine
                                                                                strut. Access is
                                                                                through access panel
                                                                                621BB on the right wing
                                                                                leading edge.
                                                                                a. Verify the manual
                                                                                override handle on the
                                                                                engine fuel spar valve
                                                                                actuator is in the
                                                                                CLOSED position.
                                                                                b. Repair or replace any
                                                                                engine fuel spar valve
                                                                                actuator that is not in
                                                                                the CLOSED position
                                                                                (refer to Boeing AMM 28-
                                                                                22-11).
----------------------------------------------------------------------------------------------------------------

(h) No Alternative Actions or Intervals

    After accomplishment of the maintenance or inspection program
revision required by paragraph (g) of this AD, no alternative
actions (e.g., inspections) or intervals may be used unless the
actions or intervals are approved as an alternative method of
compliance (AMOC) in accordance with the procedures specified in
paragraph (i)(1) of this AD.

(i) 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 paragraph (j) 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.

(j) Related Information

    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, WA
98057-3356; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>
(k) Material Incorporated by Reference

    None.

    Issued in Renton, Washington, on September 7, 2015.
Jeffrey E. Duven,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.

[FR Doc. 2015-23117 Filed 9-15-15; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: January 26, 2007 (Volume 72, Number 17)]
[Notices]
[Page 3815]
[DOCID:fr26ja07-59]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP07-129-000]

Columbia Gas Transmission Corporation; Notice of Penalty Revenue
Crediting Report

January 17, 2007.
    Take notice that on January 12, 2007, Columbia Gas Transmission
Corporation (Columbia) tendered for filing a penalty revenue crediting
report pursuant to section 19.6 of the general terms and conditions of
its FERC Gas Tariff, Second Revised Volume No. 1. Columbia must file a
report with the Commission showing any Penalty Revenues Columbia has
received during the contract year (November 1 to October 31), any
Columbia costs netted against the Penalty Revenues, and the resulting
Penalty Revenue credits due to Non-Penalized Shippers for each month of
the contract year. Columbia is providing the attached Penalty Revenue
Crediting Report for the 2005-2006 contract year.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211 and 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the date as indicated
below. Anyone filing an intervention or protest must serve a copy of
that document on the Applicant. Anyone filing an intervention or
protest on or before the intervention or protest date need not serve
motions to intervene or protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov.
 Persons unable to file electronically should submit an

original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the

``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For

TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern Time January 24, 2007.

Magalie R. Salas,
Secretary.
[FR Doc. E7-1145 Filed 1-25-07; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 78, Number 44 (Wednesday, March 6, 2013)]
[Notices]
[Page 14538]
[FR Doc No: 2013-05221]

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

ENVIRONMENTAL PROTECTION AGENCY

[FRL--9788-1]

Notification of a Public Teleconference of the Clean Air
Scientific Advisory Committee

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: The EPA Science Advisory Board (SAB) Staff Office announces a
public teleconference of the Clean Air Scientific Advisory Committee
(CASAC) to review its draft letters on EPA's Integrated Science
Assessment for Lead (Third External Review Draft--November 2012) and
EPA's Policy Assessment for the Review of the Lead National Ambient Air
Quality Standards (First External Review Draft--January 2013).

DATES: The CASAC will hold a teleconference on Wednesday, May 8, 2013,
from 1:00 p.m. to 3:00 p.m. (Eastern Time).

ADDRESSES: The CASAC public teleconference will take place via
telephone only.

FOR FURTHER INFORMATION CONTACT: Any member of the public who wants
further information concerning the CASAC's public teleconference may
contact Dr. Holly Stallworth, Designated Federal Officer (DFO) via
telephone at<PHONE_NUMBER> or email at<EMAIL_ADDRESS>
General information concerning the CASAC can be found on the EPA Web
site at http://www.epa.gov/casac.

SUPPLEMENTARY INFORMATION: The CASAC was established pursuant to the
Clean Air Act (CAA) Amendments of 1977, codified at 42 U.S.C.
7409D(d)(2), to provide advice, information, and recommendations to the
Administrator on the scientific and technical aspects of issues related
to the criteria for air quality standards, research related to air
quality, sources of air pollution, and the strategies to attain and
maintain air quality standards and to prevent significant deterioration
of air quality. The CASAC is a Federal Advisory Committee chartered
under the Federal Advisory Committee Act (FACA), 5 U.S.C., App. 2.
Pursuant to FACA and EPA policy, notice is hereby given that the CASAC
will hold a public teleconference review its draft letters on EPA's
third external review draft of the Integrated Science Assessment for
Lead (November 2012) and EPA's first external review draft of the
Policy Assessment for the Review of the Lead National Ambient Air
Quality Standards (January 2013). These draft letters are being
prepared as part of CASAC's review of the National Ambient Air Quality
Standards (NAAQS) for lead. The CASAC will comply with the provisions
of FACA and all appropriate SAB Staff Office procedural policies.
Section 109(d)(1) of the CAA requires that the Agency periodically
review and revise, as appropriate, the air quality criteria and the
NAAQS for the six ``criteria'' air pollutants, including lead. EPA is
currently reviewing the primary (health-based) and secondary (welfare-
based) NAAQS for lead. The CASAC Lead Review Panel previously reviewed
EPA's first external review draft of the Integrated Science Assessment
for Lead (May 2011) as reported in a CASAC letter to the EPA
Administrator, dated December 9, 2011 (EPA-CASAC-12-002) and previously
reviewed EPA's second external review draft of the Integrated Science
Assessment for Lead (February 2012) as reported in a CASAC letter to
the EPA Administrator, dated July 20, 2012 (EPA-CASAC-12-005). The
CASAC Lead Review Panel met in a face-to-face meeting on February 5-6,
2013 to review EPA's third external review draft of the Integrated
Science Assessment for Lead (November 2012) and EPA's first external
review draft of the Policy Assessment for the Review of the Lead
National Ambient Air Quality Standards (January 2013).
    Technical Contacts: Any technical questions concerning the
Integrated Science Assessment for Lead (Third External Review Draft--
November 2012) should be directed to Dr. Ellen Kirrane
<EMAIL_ADDRESS>and technical questions concerning the Policy
Assessment for the Review of the Lead National Ambient Air Quality
Standards (First External Review Draft--January 2013) should be
directed to Dr. Deirdre Murphy (murphy.deirdre@epa.gov).
    Availability of Meeting Materials: Prior to the teleconference,
CASAC's draft letters, the agenda and other materials will be
accessible through the calendar link on the blue navigation bar at
http://www.epa.gov/casac/.
    Procedures for Providing Public Input: Public comment for
consideration by EPA's federal advisory committees and panels has a
different purpose from public comment provided to EPA program offices.
Therefore, the process for submitting comments to a federal advisory
committee is different from the process used to submit comments to an
EPA program office.
    Federal advisory committees and panels, including scientific
advisory committees, provide independent advice to EPA. Members of the
public can submit relevant comments for a federal advisory committee to
consider pertaining to EPA's charge to the panel or meeting materials.
Input from the public to the CASAC will have the most impact if it
provides specific scientific or technical information or analysis for
CASAC panels to consider or if it relates to the clarity or accuracy of
the technical information. Members of the public wishing to provide
comment should contact the DFO directly.
    Oral Statements: In general, individuals or groups requesting an
oral presentation will be limited to three minutes for public
teleconferences. Interested parties should contact Dr. Holly
Stallworth, DFO, in writing (preferably via email) at the contact
information noted above by May 1, 2013, to be placed on the list of
public speakers for the public teleconference. Written Statements:
Written statements should be supplied to Dr. Holly Stallworth, DFO, via
email at the contact information noted above by May 1, 2013 for the
public teleconference. Written statements should be supplied in one of
the following electronic formats: Adobe Acrobat PDF, MS Word, MS
PowerPoint, or Rich Text files in IBM-PC/Windows 98/2000/XP format. It
is the SAB Staff Office general policy to post written comments on the
Web page for advisory meetings or teleconferences. Submitters are
requested to provide an unsigned version of each document because the
SAB Staff Office does not publish documents with signatures on its Web
sites. Members of the public should be aware that their personal
contact information, if included in any written comments, may be posted
to the CASAC Web site. Copyrighted material will not be posted without
explicit permission of the copyright holder.
    Accessibility: For information on access or services for
individuals with disabilities, please contact Dr. Holly Stallworth at
(202) 564-2073 or<EMAIL_ADDRESS>To request accommodation of
a disability, please contact Dr. Holly Stallworth preferably at least
ten days prior to the public meeting and/or teleconference to give EPA
as much time as possible to process your request.

    Dated: February 25, 2013.
Thomas H. Brennan,
 Deputy Director, EPA Science Advisory Board Staff Office.
[FR Doc. 2013-05221 Filed 3-5-13; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 80, Number 4 (Wednesday, January 7, 2015)]
[Notices]
[Pages 892-893]
[FR Doc No: 2015-00002]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2005-N-0453, FDA-2003-N-0196, and FDA-2006-O-0314]

Sunscreen Feedback Letters; Notice of Availability Under the
Sunscreen Innovation Act

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for comments.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of letters containing FDA's initial determinations and
feedback on safety and effectiveness data submitted to demonstrate that
certain active ingredients are generally recognized as safe and
effective (GRASE) and not misbranded for use in over-the-counter (OTC)
sunscreen drug products (sunscreen feedback letters). We are taking
this action under the Sunscreen Innovation Act (SIA).

DATES: Submit either electronic or written comments by February 23,
2015. Sponsors may submit written requests for a meeting with FDA to
discuss these proposed sunscreen orders by February 6, 2015.

ADDRESSES: Submit electronic comments 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. All comments should clearly identify the specific
active ingredient(s) and docket number(s) to which the comments apply.

FOR FURTHER INFORMATION CONTACT: Kristen Hardin, Division of
Nonprescription Drug Products, Center for Drug Evaluation and Research,
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm.
5491, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of six sunscreen feedback
letters on its Web site that contain the Agency's tentative
determinations and feedback on safety and effectiveness data submitted
to demonstrate that certain active ingredients are GRASE and not
misbranded for use in OTC sunscreen drug products. We are taking this
action under the SIA (Pub. L. 113-195), enacted November 26, 2014.
Before the SIA was enacted, these sunscreen feedback letters were
issued to persons seeking OTC monograph status for nonprescription
sunscreen active ingredients using the Time and Extent Application
(TEA) process under FDA regulations in 21 CFR 330.14, and were also
previously made available to the public in the docket.
    The SIA amended the Federal Food, Drug, and Cosmetic Act (FD&C Act)
to, among other things, provide an alternative process for FDA to
review the safety and effectiveness of nonprescription sunscreen active
ingredients. The SIA establishes new procedures for establishing the
conditions under which sunscreens containing active ingredients that
have been reviewed through the SIA process and found in a final
sunscreen order to be GRASE and not misbranded may be marketed in the
United States.
    Section 586C(b)(3) of the FD&C Act, as added by the SIA, provides
that sunscreen feedback letters issued before the SIA was enacted are
deemed to be proposed sunscreen orders. Proposed sunscreen orders
contain FDA's tentative determination that a nonprescription sunscreen
active ingredient or combination of nonprescription sunscreen active
ingredients: (A) Is GRASE and not misbranded if marketed in accordance
with such order; (B) is not GRASE and is misbranded; or (C) is not
GRASE and is misbranded because the data are insufficient to classify
the active ingredient or combination of ingredients as GRASE and not
misbranded, and additional data are necessary to allow FDA to determine
otherwise. All of the proposed sunscreen orders addressed in this
notice have been tentatively classified under category (C), as
described in the previous sentence. Accordingly, additional data will
be needed to support a determination that any or all of the active
ingredients they address are GRASE and not misbranded.

II. Sunscreen Feedback Letters Deemed To Be SIA Proposed Orders

    The six feedback letters that are deemed to be proposed orders
under the SIA are identified in Table 1. They can be viewed
electronically on FDA's Web site at http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/UnderstandingOver-the-CounterMedicines/ucm239463.htm, under the heading ``FDA Regulatory
Action on Sunscreen.'' Related documents, including safety and efficacy
data submissions, can be accessed in the corresponding dockets,
identified in Table 1, at http://www.regulations.gov. The letters and
associated information may also be viewed by visiting FDA's Division of
Dockets Management (see ADDRESSES).

                    Table 1--OTC Sunscreen Feedback Letters Deemed To Be SIA Proposed Orders
----------------------------------------------------------------------------------------------------------------
             Active ingredient                          Sponsor                Date issued       Docket No. \1\
----------------------------------------------------------------------------------------------------------------
Bemotrizinol...............................  Ciba Specialty Chemicals Corp         11/13/2014    FDA-2005-N-0453
Bisoctrizole...............................  Ciba Specialty Chemicals Corp           9/3/2014    FDA-2005-N-0453
Drometrizole Trisiloxane...................  L'Oreal USA Products, Inc....          8/29/2014    FDA-2003-N-0196
Octyl Triazone.............................  BASF AG......................          6/23/2014    FDA-2003-N-0196
Amiloxate..................................  Symrise, Inc.................          2/25/2014    FDA-2003-N-0196
                                             Ego Pharmaceuticals Pty. Ltd.
Diethylhexyl Butamido Triazone.............  3V Inc.......................          2/21/2014    FDA-2006-O-0314
----------------------------------------------------------------------------------------------------------------
\1\ Each letter was previously posted in the docket shown in Table 1 on the date that it was issued.

    Sponsors may submit a written request for a meeting with FDA to
discuss any of these proposed sunscreen orders (see DATES). Submit
meeting requests electronically to www.regulations.gov or in writing to
the Division of Dockets Management (see ADDRESSES), identified with the
active ingredient name(s), the corresponding docket number(s) shown in
Table 1, and the heading ``Sponsor Meeting Request.'' To facilitate
your request, please also send a copy to Kristen Hardin (see FOR
FURTHER INFORMATION CONTACT).

III. Comments

    Interested persons may submit either electronic comments about the
proposed orders discussed in 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 appropriate docket number(s) and
active ingredient name(s) shown in Table 1 for the proposed order(s)
that the comments address. Comments on this notice may be viewed in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday, and will be posted to the appropriate docket(s) at
http://www.regulations.gov.

    Dated: December 31, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-00002 Filed 1-6-15; 8:45 am]
BILLING CODE 4164-01-P