[Federal Register Volume 86, Number 10 (Friday, January 15, 2021)]
[Rules and Regulations]
[Pages 3769-3780]
[FR Doc No: 2021-00044]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2018-1046; Product Identifier 2018-CE-049-AD; Amendment
39-21371; AD 2020-26-16]
RIN 2120-AA64

Airworthiness Directives; Piper Aircraft, Inc. Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: The FAA is adopting a new airworthiness directive (AD) for
certain Piper Aircraft, Inc. (Piper) Models PA-28-151, PA-28-161, PA-
28-181, PA-28-235, PA-28R-180, PA-28R-200, PA-28R-201, PA-28R-201T, PA-
28RT-201, PA-28RT-201T, PA-32-260, PA-32-300, PA-32R-300, PA-32RT-300,
and PA-32RT-300T airplanes. This AD was prompted by a report of a wing
separation caused by fatigue cracking in a visually inaccessible area
of the lower main wing spar cap. This AD requires calculating the
factored service hours for each main wing spar to determine when an
inspection is required, inspecting the lower main wing spar bolt holes
for cracks, and replacing any cracked main wing spar. The FAA is
issuing this AD to address the unsafe condition on these products.

DATES: This AD is effective February 16, 2021.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of February 16,
2021.

ADDRESSES: For service information identified in this final rule,
contact Piper Aircraft, Inc., 2926 Piper Drive, Vero Beach, Florida
32960; phone:<PHONE_NUMBER>; website: https://www.piper.com. You may
view this service information at the FAA, Airworthiness Products
Section, Operational Safety Branch, 901 Locust, Kansas City, Missouri
64106. For information on the availability of this material at the FAA,
call<PHONE_NUMBER>. It is also available at https://www.regulations.gov by searching for and locating Docket No. FAA-2018-
1046.

Examining the AD Docket

    You may examine the AD docket at https://www.regulations.gov by
searching for and locating Docket No. FAA-2018-1046; or in person at
Docket Operations between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays. The AD docket contains this final rule, any
comments received, and other information. The address for Docket
Operations is 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: Dan McCully, Aviation Safety Engineer,
Atlanta ACO Branch, FAA, 1701 Columbia Avenue, College Park, Georgia
30337; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Background

    The FAA issued a notice of proposed rulemaking (NPRM) to amend 14
CFR part 39 by adding an AD that would apply to certain Piper Models
PA-28-140, PA-28-150, PA-28-151, PA-28-160, PA-28-161, PA-28-180, PA-
28-181, PA-28-235, PA-28R-180, PA-28R-200, PA-28R-201, PA-28R-201T, PA-
28RT-201, PA-28RT-201T, PA-32-260, and PA-32-300 airplanes. The NPRM
published in the Federal Register on December 21, 2018 (83 FR 65592).
The NPRM was prompted by a fatal accident involving wing separation on
a Piper Model PA-28R-201 airplane. An investigation revealed a fatigue
crack in a visually inaccessible area of the lower main wing spar cap.
The NPRM included other model airplanes with similar wing spar
structures as the Model PA-28R-201. Based on airplane usage history,
the FAA determined that only those airplanes with higher risk for
fatigue cracks (airplanes with a significant history of operation in
flight training or other high-load environments) should be subject to
the inspection requirements proposed in the NPRM.
    Because airplanes used in training and other high-load environments
are typically operated for hire and have inspection programs that
require 100-hour inspections, the FAA determined the number of 100-hour
inspections an airplane has undergone would be the best indicator of
the airplane's usage history. Accordingly, the FAA developed a factored
service hours formula based on the number of 100-hour inspections
completed on the airplane.
    In the NPRM, the FAA proposed to require a review of the airplane
maintenance records to determine the number of 100-hour inspections and
the application of the factored service hours formula to identify when
an airplane meets the criteria for the proposed eddy current inspection
of the lower main wing spar bolt holes. The FAA also proposed to
require inspecting the lower main wing spar bolt holes for cracks once
a main wing spar exceeds the specified factored service hours and

replacing any main wing spar when a crack is indicated. The maintenance
records review to determine the factored service hours proposed in the
NPRM would only apply when an airplane has either accumulated 5,000 or
more hours time-in-service (TIS); has had either main wing spar
replaced with a serviceable (more than zero hours TIS) main wing spar;
or has missing and/or incomplete maintenance records.
    The FAA issued a supplemental notice of proposed rulemaking (SNPRM)
to amend 14 CFR part 39 by adding an AD that would apply to certain
Piper Models PA-28-151, PA-28-181, PA-28-235, PA-28R-180, PA-28R-200,
PA-28R-201, PA-28R-201T, PA-28RT-201, PA-28RT-201T, PA-32-260, PA-32-
300, PA-32R-300, PA-32RT-300, and PA-32RT-300T airplanes. The SNPRM
published in the Federal Register on June 3, 2020 (85 FR 34121). The
SNPRM was prompted by comments received on the NPRM and further
analysis by the FAA. The FAA determined that some additional airplane
models are likely affected by the unsafe condition and should be
included in the applicability, while other models that are not affected
should be removed from the applicability. Consequently, in the SNPRM,
the FAA proposed to revise the applicability and the estimated cost
associated with the proposed AD actions. The SNPRM also clarified the
language in the applicability and some of the proposed actions. In
addition, the SNPRM no longer allowed replacement of the wing spar with
a used part. The FAA determined replacement of the wing spar with a
part of unknown operational history would not ensure an acceptable
level of safety. After the NPRM was published, Piper issued a service
bulletin that contains procedures for the eddy current inspection. The
SNPRM proposed to require using the eddy current inspection contained
in that service bulletin instead of the inspection procedure in the
appendix to the NPRM.
    The FAA developed a flow chart that may assist operators in
complying with this AD. The flow chart may be found at https://www.regulations.gov by searching for and locating Docket No. FAA-2018-
1046.
    The FAA is issuing this AD to address the unsafe condition on these
products.

Discussion of Final AD

Comments

    The FAA received comments on the SNPRM from 42 commenters. The
majority of the commenters were individuals. The remaining commenters
included Piper, governmental agencies such as the National
Transportation Safety Board (NTSB) and the Civil Aviation Safety
Authority of Australia (CASA), and organizations such as the Aircraft
Owners and Pilots Association (AOPA), the General Aviation and
Manufacturer's Association (GAMA), the Experimental Aircraft
Association (EAA), and the Piper Flying Association. The following
presents the comments received on the SNPRM and the FAA's response to
each comment.

A. Supportive Comments

    The NTSB and two individual commenters supported the AD without any
recommended changes. Three other individual commenters supported the AD
but requested changes discussed below.

B. Requests for Additional Information

    CASA requested information on whether a bolt hole eddy current
inspection would have detected the crack in the 1993 accident airplane.
    The FAA agrees to provide the requested information. Because it was
located slightly beyond the detectable range of a bolt hole eddy
current inspection, the crack in the 1993 accident airplane would not
have been detected by an eddy current inspection of the bolt holes.
Although the airplane had previously undergone dye penetrant inspection
of the bolt holes, the crack would not have been detectable under that
method either due to its location beyond the bolt hole perimeter and
beneath the web doubler.\1\ The 1993 accident disclosed evidence of a
fatigue crack initiation in a wing spar similar to that of the 2018
accident aircraft, N106ER (the accident that prompted this AD). In
addition to having high hours TIS, the fatigue crack was very near the
inspection location addressed by this AD. As such, the FAA included the
1993 accident in the risk analysis process for this AD.
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    \1\ The supporting materials for NTSB accident NYC93FA140 are
available in the NTSB Docket at https://dms.ntsb.gov/pubdms/search/hitlist.cfm?docketID=4323&CFID=1643539&CFTOKEN=74133c21c3cf3d72-C9941D08-5056-942C-92883A7C17DB9FF3.
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    CASA and an individual commenter requested information comparing
the failures in the 1987 and 1993 accidents with the failure of N106ER
(the accident that prompted this AD). CASA specifically asked whether
these wing spars failed at the same outer bolt hole location.
    The FAA agrees to provide additional information. Both airplanes in
question (N8191V, the 1987 accident; and N2093A, the 1993 accident)
experienced wing separations at the outboard bolt holes of the lower
spar cap. The NTSB Metallurgist's Factual Report in the 1987 accident,
Materials Laboratory Report No. 87-89, dated August 17, 1987, found
that fatigue had initiated at two locations on the lower surface of the
left wing spar cap near the forward most outboard, spar to carry
through, bolt hole. The report further found the fatigue had propagated
completely through the forward flange and partially into the aft flange
and spar web.\2\ The Metallurgist's Factual Report in the 1993
accident, Report No. 93-34, dated December 15, 1993, found that the
lower cap was fractured through the most outboard pair of bolts
connecting the spar and carry-through.\3\ The FAA notes that the NTSB
Final Report for the 1993 accident states the investigation could not
determine whether an uncracked wing would have failed.\4\
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    \2\ Report No. 87-89 is available in the NTSB Docket for NTSB
accident FTW87FA088 at https://dms.ntsb.gov/pubdms/search/document.cfm?docID=475398&docketID=62694&mkey=96975.
    \3\ Report No. 93-34 is available in the NTSB Docket for NTSB
accident NYC93FA140 at https://dms.ntsb.gov/pubdms/search/document.cfm?docID=487590&docketID=4323&mkey=38586.
    \4\ The NTSB Aviation Accident Final Report for NTSB accident
NYC93FA140 is available on the NTSB's website at https://app.ntsb.gov/pdfgenerator/ReportGeneratorFile.ashx?EventID=20001211X13212&AKey=1&RType=Final&IType=FA.
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    CASA and an individual commenter requested information on the
inspection method used to detect cracks on aircraft N104ER. CASA asked
whether the inspection method described in Piper Service Bulletin No.
1345, dated March 27, 2020 (Piper SB No. 1345), was used. The
individual commenter asked whether bolt hole eddy current is the most
suitable method if it was used on N104ER and did not reveal the cracks
that caused the wing failure.
    The FAA agrees to provide the requested information. Aircraft
N104ER was used in the investigation of the 2018 accident due to the
similarities in structure and operational use to the accident aircraft.
The initial high frequency eddy current inspection of N104ER was
conducted by a local FAA-approved repair station contracted by the
owner. The FAA could not determine why the inspection conducted by the
FAA-approved repair station did not detect cracks because this
inspection did not involve the investigative team. Also, the inspection
occurred prior to the development of the inspection procedures required
by this AD. The investigative team conducted a second high frequency
eddy current inspection, in the development of the

inspection procedures required by the AD, with the wings removed, which
detected a crack. The team conducted an additional high frequency eddy
current inspection after reinstalling the wings to validate the
inspection process, which confirmed the presence of a crack.\5\
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    \5\ The supporting materials for NTSB accident ERA18FA120 are
available in the NTSB Docket at https://dms.ntsb.gov/pubdms/search/hitlist.cfm?docketID=62694&CFID=95094&CFTOKEN=b616b3892cb482f1-5B544A63-5056-942C-92C71C2E6BFF1D97.
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    Another commenter requested information on the methodology used by
the FAA for identifying specific wing loads, the applied stress
locations, and their influence on fatigue life, and the rationale for
selecting those aircraft within 95 percent of the baseline load case
for the applicability.
    The FAA agrees to provide the requested information. The
methodology used by the FAA for identifying specific wing loads for
gust, maneuvering, and landing loads comes from 14 CFR part 23 (Amdt
63) Subpart C-Structure and Advisory Circular 23-13A Fatigue, Fail-
Safe, and Damage Tolerance Evaluation of Metallic Structure for Normal,
Utility, Acrobatic, and Commuter Category Airplanes.
    A subsequent analysis calculated damage factors using variables for
each of the various PA-28/32 models. The variables include maximum
design weight (Wmax), maximum design cruising speed
(Vcmax), spar cross section properties, and spanwise center
of pressure location for each loading category mentioned above. The
results for each model/load category are divided by the PA-28R-201
(accident aircraft model) results. Any model with a damage factor ratio
greater than 0.94 is included in the effectivity of this AD.
    The 0.94 factor cutoff was arrived at by observing a natural break
in the resulting damage factor numbers and the Palmgren-Miner linear
damage hypothesis or Miner's Rule. This theory shows that a linear
decrease in stress (damage factor in this case) results in an
exponential increase in fatigue life. The FAA believes this level of
risk is appropriate for the purpose of this one-time inspection. The
applied stress location is at the lower spar cap attachment to the
fuselage carry through channel, outboard row of fasteners. This is the
location of the fatigue failure on the accident airplane.

C. Comments Regarding the FAA's Justification of the Unsafe Condition

    Piper and GAMA requested the AD be withdrawn because the completed
NTSB investigation invalidates the FAA's basis for issuing an AD. These
commenters asserted that, based on the NTSB's findings, the operator's
failure to follow existing maintenance requirements was responsible for
the accident involving N106ER.
    The FAA disagrees that the NTSB's investigation invalidates the
FAA's basis for issuing this AD. The spar surface is not visually
accessible during routine inspections required by existing maintenance
requirements, because the lower spar cap is obscured by the
installation of the web doubler on the upper surface and the wing skin
on the lower surface. Therefore, a well-developed crack may only be
visually detected after the spar crack progresses into the doubler. The
claim that an operator may fail to detect a crack that had progressed
to an extent that caused cracking in the overlying web doubler only
serves to reinforce the need for detecting fatigue cracks in the spar
before they reach a critical nature.

D. Comments Regarding Applicability

    Piper, AOPA, EAA, and several individual commenters requested the
FAA revise the applicability of the AD because it is still too broad
and includes models not representative of the accident airplane.
    EAA requested the FAA ensure that only the appropriate aircraft, in
general, are subject to the AD. Piper and AOPA asserted that the AD
should not include Models PA-28-151, PA-28-181, PA-32R-300, and PA-
32RT-300T airplanes. In support, Piper stated that the PA-28-151, PA-
28-181, and PA-32R-300 models have ``stress per g'' measurements that
do not meet the 95 percent threshold established by the FAA for
comparison to the accident airplane. CASA and eight individual
commenters questioned why the proposed AD applies to the Model PA-28-
151 when that model is structurally similar to the Model PA-28-161,
which the FAA proposed to remove from the applicability in the SNPRM.
Two individual commenters requested the AD apply to the Model PA-28-
161, because of the longer wing structure. Piper and three individual
commenters stated the PA-32R-300 and certain PA-32-300 models do not
share the same wing construction and installation details as the
accident airplane model.
    The FAA disagrees with removing Models PA-28-151, PA-28-181, and
PA-32R-300 from the applicability of the AD. The FAA used the following
load cases, provided by Piper, for comparison to the accident airplane:
Gust damage factor, maneuver damage factor, and landing damage factor.
The included models each had one or more load cases that exceed 94
percent of the baseline Model PA-28R-201. Several models had individual
load cases exceeding 100 percent of the baseline value.
    The FAA partially agrees with the comments regarding the similarity
between the Model PA-28-151 and the Model PA-28-161. In determining
pertinent load cases, the FAA used factors such as maximum gross
takeoff weight and maximum cruise speed in combination with structural
considerations. In the SNPRM, the FAA proposed to remove Model PA-28-
161 from the applicability based on initial load calculations based on
a maximum gross takeoff weight of 2,240 lbs. Additional analysis
indicated that the maximum gross takeoff weight is not uniform among
all Model PA-28-161 variants, and that some variants are certificated
to a maximum gross takeoff weight that brings the gust damage factor
load case to above 94 percent of the baseline. Accordingly, this AD
applies to the Model PA-28-161.
    The FAA disagrees with removing the Model PA-32R-300 and certain
Model PA-32-300 airplanes from the applicability based on wing
construction.
    Although the FAA acknowledges the differing wing structures among
some models, that structure was taken into consideration during loads
analysis in terms of inertia calculations for the each cross section.

E. Comments Regarding the Compliance Time

    An individual commenter expressed concern that the FAA's factored
service hours did not align with the compliance time in Piper SB No.
1345. The commenter stated that Piper's compliance time of 5,000 hours
TIS is simpler and a more conservative approach to safety.
    The FAA partially agrees. While using hours TIS is a simpler
approach, it would create the possibility of requiring an unnecessary
inspection long before any fatigue crack might be expected to form. The
FAA established 5,000 factored service hours as a method of delaying or
eliminating inspection requirements for many personal use, lower risk
airplanes. This AD will require an inspection within 100 hours TIS
after reaching 5,000 factored service hours.
    Another commenter requested the FAA determine the compliance time
based on an estimate of the number of airplanes that will need to be
inspected and the number of qualified eddy current inspectors, to allow
sufficient time for all airplanes in the fleet to be

inspected. The commenter stated it is unacceptable for airplanes to be
grounded for a significant amount of time because of an insufficient
number of eddy current inspectors or equipment.
    The FAA disagrees that a change to the compliance time is
necessary. The FAA anticipates that less than 50 percent of applicable
airplanes will have accumulated the 5,000 TIS necessary for the logbook
review. The FAA also anticipates that the majority of those airplanes
will not need an inspection after the logbook review. Calculating the
number of qualified and available eddy current inspectors would be too
speculative, as it is largely based on current demand.
    One commenter requested that the FAA convert the AD into an
emergency AD so that data from the inspections can be collected as soon
as possible.
    Considering the number of known failures, the severity of the
outcome, and number of cracks detected during the investigation, the
FAA determined that an emergency AD was not necessary. The FAA did not
change this AD based on these comments.

F. Comments Regarding the Requirements Proposed in the SNPRM Request To
Allow Replacement of the Spar With a Used Spar

    The Piper Flying Association and four individual commenters
requested the FAA change the proposed requirement to install a new
(zero hours TIS) spar if cracks were detected. These commenters stated
that any spar that has passed the eddy current inspection is an
airworthy spar and should be allowed as a replacement spar. Two of the
commenters noted that the unavailability of new spars would effectively
ground aircraft that fail the eddy current inspection.
    The FAA agrees and has revised this AD to allow the installation of
a used (more than zero hours TIS) wing spar that has passed the eddy
current inspection.
    An individual commenter requested the FAA compel Piper to restore
availability of replacement parts.
    The FAA disagrees. As a federal agency, the FAA is responsible for
all directives, policies, and mandates issued under its authority. The
FAA does not have the authority to require a manufacturer to produce
new parts.
Requests for Information About the Service Bulletin
    An individual commenter asked how operators can record compliance
with the AD when the required service bulletin does not apply to all of
the models in the AD. Another individual commenter asked why the AD
only incorporates part of the instructions in Piper SB No. 1345.
    The FAA's regulations specify that when there is a conflict between
an AD and a service document incorporated by reference in the AD,
operators must follow the requirements of the AD. See 14 CFR 39.27.
Since this AD differs from Piper SB No. 1345, as described in the
Differences Between this AD and the Service Information section, the AD
only requires the inspection method portion of Piper SB No. 1345.
Requests for Different Inspection Methods
    An individual commenter suggested guided wave technology as a
better, less intrusive, and less expensive inspection method. Another
individual commenter suggested using dye penetrant inspection without
bolt removal as a less aggressive method for early detection, even if
it meant more frequent inspections.
    The FAA disagrees. The FAA, Piper, and the NTSB considered several
inspection options. Guided wave is not a preferred method for this AD
due to accessibility issues and the need to detect longitudinal, as
opposed to circumferential, cracks. To be detectable using a dye
penetrant or fluorescent penetrant method, a crack that initiated at a
wing spar attach bolt hole would have had to propagate through the web
doubler and beyond the perimeter of the washer(s). A crack of that size
would have already dangerously compromised the strength of the spar
cap.
    The FAA did not change this AD based on these comments.
Requests for Different Repair Options
    An individual commenter observed that if one wing indicates fatigue
cracks, then replacing both wings may be warranted, since the opposite
wing would have experienced the same usage history.
    The FAA partially agrees. Fatigue cracking in one wing would
warrant an increased level of concern for the opposite wing. However,
the FAA determined that replacement of both wings is not required when
only one wing has failed the inspection. Certain factors that can
accelerate the initiation of a fatigue crack on one wing may not be
present on the opposite wing (for example, prior damage from operations
or maintenance).
    Another individual commenter requested the FAA consider a cold
working process (split sleeve cold expansion) on the bolt holes to
minimize future fatigue cracking.
    The FAA partially agrees. Piper provided the FAA with cold working
data in support of a proposed repair and fatigue mitigation process for
the wing spars. Cold working has been considered and may be
investigated further should the inspection reports received as a result
of this AD indicate that such action is required.
    One individual commenter suggested using different washers,
adjusting the bolt torque to the lowest value of the acceptable range,
and installing a doubler plate to alleviate stress concentrations.
    The FAA disagrees. Load transfer into the spar cap does not rely on
a washer to help evenly transfer the load. A larger washer would not
lower the stress concentration as the critical geometry is the fastener
diameter and the edge distance associated with the diameter, not the
washer size. Staying within the torque values for the bolt will not
alleviate the loading in the bolt enough to decrease the stress
concentration and could lead to further issues such as the bolt being
under torqued, which would worsen the fatigue life. A doubler repair
has been considered and may be investigated further should the
inspection reports received as a result of this AD indicate that such
action is required.
    An additional individual commenter asked if changing the outer
holes to the next smaller size would result in a more favorable stress
distribution.
    The FAA disagrees. While a smaller hole may decrease the load in
the fastener, the gain is offset by the increase in stress
concentration.
    The FAA has not changed the AD based on these comments.
Request for Safe Life
    An individual commenter suggested establishing a life limit as a
solution based on a comparison of any safe life analysis conducted by
Piper with the known fatigue failures.
    The FAA partially agrees. Fatigue safe life has been considered and
may be pursued as an option should the inspection reports received as a
result of this AD indicate that further action is required. Because
this AD is interim in nature and intended to gather fleet condition
data based on these comparisons, this AD does not contain repetitive or
terminating actions.
    The FAA did not make any changes to this AD based on this comment.
Request To Revise the Reporting Information
    Piper requested the FAA revise the inspection results form to
include Piper's mailing address.

    The FAA agrees and has added Piper's mailing address to the
inspection results form.

G. Comments Previously Addressed in the SNPRM

    AOPA, EAA, and several individuals submitted comments that were
substantially the same as comments the FAA received on the NPRM. These
comments pertain to issues such as the FAA's decision to issue the AD
as interim action, whether the FAA should issue a special airworthiness
information bulletin or airworthiness concern sheet instead of an AD,
how the FAA determined the AD applicability, whether the FAA should
issue this AD considering the cost and risk associated with the removal
and reinstallation of the airplane wings/bolts, alternatives for
instances where maintenance records were missing or incomplete, how to
count 100-hour inspections, the FAA's hourly labor rate, the estimated
number of hours for the eddy current inspection, and indirect costs.
The FAA previously addressed each of these comments in the SNPRM.

H. Out of Scope Comments

    The FAA also received and reviewed a few comments that stated the
commenter's viewpoint without a suggestion specific to the AD or
otherwise did not make a request the FAA can act on. These comments are
outside the scope of this AD.

Other Changes to the Final AD

    The FAA removed two serial-numbered airplanes from the
applicability that were included in the SNPRM because those airplanes
were previously inspected using the current procedures and witnessed by
the FAA. The FAA determined those airplanes are not subject to the
unsafe condition addressed by this AD. The FAA also added language to
clarify the procedures for when a wing is not installed on the airplane
and clarified some of the language in the examples and figures.

Conclusion

    The FAA reviewed the relevant data, considered any comments
received, and determined that air safety requires adopting this AD as
proposed. Accordingly, the FAA is issuing this AD to address the unsafe
condition on these products. Except for minor editorial changes and the
changes described previously, this AD is adopted as proposed in the
SNPRM. None of the changes will increase the economic burden on any
operator.

Related Service Information Under 1 CFR Part 51

    The FAA reviewed Piper Service Bulletin No. 1345, dated March 27,
2020 (Piper SB No. 1345). This service bulletin specifies procedures
for doing an eddy current inspection and instructions to report the
results of the inspection to Piper and to replace the wing, wing spar,
or spar section as necessary. This service information is reasonably
available because the interested parties have access to it through
their normal course of business or by the means identified in the
ADDRESSES section.

Other Related Service Information

    The FAA reviewed Piper Service Bulletin No. 886, dated June 8,
1988; and Piper Service Bulletin SB 978A, dated August 6, 1999. These
service bulletins contain procedures for determining initial and
repetitive inspection times based on the aircraft's usage and visually
inspecting the wing lower spar caps and the upper wing skin adjacent to
the fuselage and forward of each main spar for cracks. The FAA also
reviewed Piper Service Letter No. 997, dated May 14, 1987, which
contains procedures for replacing airplane wings.

Differences Between This AD and the Service Information

    Piper SB No. 1345 specifies doing the eddy current inspection upon
reaching 5,000 hours TIS; however, this AD requires using the factored
service hours to identify the airplanes at the highest risk of
developing fatigue cracks. Piper SB No. 1345 also specifies using its
feedback form to report the eddy current inspection results, but this
AD requires the use of a different form attached as appendix 1.

Interim Action

    The FAA considers this AD to be an interim action. The inspection
reports will provide the FAA additional data for determining the number
of cracks present in the fleet. After analyzing the data, the FAA may
take further rulemaking action.

Costs of Compliance

    The FAA estimates that this AD affects 5,440 airplanes of U.S.
registry. There are 10,881 airplanes of U.S. registry with a model and
serial number shown in table 1 to paragraph (c) of this AD. Based on a
sample survey, the FAA estimates that 50 percent of those U.S.-
registered airplanes will have reached the qualifying 5,000 hours TIS
necessary to do the required logbook review.
    The FAA estimates the following costs to comply with this AD:

                                                 Estimated Costs
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                                                                                Cost per       Cost on U.S.
              Action                     Labor cost            Parts cost           product         operators
----------------------------------------------------------------------------------------------------------------
Review airplane maintenance         3 work-hours x $85    Not applicable......            $255       $1,387,200
 records and calculate factored      per hour = $255.
 service hours.
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    The FAA estimates the following costs to do the eddy current
inspection. Because some airplanes are only used non-commercially and
will not accumulate the specified factored service hours in the life of
the airplane, the FAA has no way of determining the number of airplanes
that might need this inspection:

                                               On-Condition Costs
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                                                                                Cost per
                   Action                                 Labor cost                Parts cost        product
----------------------------------------------------------------------------------------------------------------
Gain access to the left-hand (LH) and right- 2 work-hours x $85 per hour = $170.             $20             190
 hand (RH) inspection areas.
Do eddy current inspections of the LH and    1 work-hour contracted service x                N/A             600
 RH lower main wing spar.                     $600 = $600.
Restore aircraft...........................  2 work-hours x $85 per hour = $170.             N/A             170

Report inspection results to the FAA and     1 work-hour x $85 per hour = $85...             N/A              85
 Piper Aircraft, Inc.
----------------------------------------------------------------------------------------------------------------

    The FAA estimates the following costs to do any necessary
replacements that would be required based on the results of the
inspection. The agency has no way of determining the number of aircraft
that might need this replacement:

                                         On-Condition Replacement Costs
----------------------------------------------------------------------------------------------------------------
             Action                      Labor cost            Parts cost              Cost per product
----------------------------------------------------------------------------------------------------------------
Replace main wing spar..........  80 work-hours x $85 per           $5,540   $12,340 per wing spar.
                                   hour = $6,800 per wing
                                   spar.
----------------------------------------------------------------------------------------------------------------

Paperwork Reduction Act

    A federal agency may not conduct or sponsor, and a person is not
required to respond to, nor shall a person be subject to a penalty for
failure to comply with a collection of information subject to the
requirements of the Paperwork Reduction Act unless that collection of
information displays a currently valid OMB Control Number. The OMB
Control Number for this information collection is 2120-0056. Public
reporting for this collection of information is estimated to take
approximately 1 hour per response, including the time for reviewing
instructions, searching existing data sources, gathering and
maintaining the data needed, and completing and reviewing the
collection of information. All responses to this collection of
information are mandatory. Send comments regarding this burden estimate
or any other aspect of this collection of information, including
suggestions for reducing this burden to: Information Collection
Clearance Officer, Federal Aviation Administration, 10101 Hillwood
Parkway, Fort Worth, TX 76177-1524.

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.
    The FAA is 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) Will not affect intrastate aviation in Alaska to the extent
that it justifies making a regulatory distinction, and
    (3) 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 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:

2020-26-16 Piper Aircraft, Inc.: Amendment 39-21371; Docket No. FAA-
2018-1046; Product Identifier 2018-CE-049-AD.

(a) Effective Date

    This airworthiness directive (AD) is effective February 16,
2021.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Piper Aircraft, Inc. (Piper) airplanes,
certificated in any category, with a model and serial number shown
in table 1 to paragraph (c) of this AD, and that meet at least one
of the criteria in paragraphs (c)(1), (2), or (3) of this AD.
    Note 1 to the introductory text of paragraph (c): An owner/
operator with at least a private pilot certificate may do the
aircraft maintenance records review to determine the applicability
as specified in paragraph (c) of this AD.
    (1) Has accumulated 5,000 or more hours time-in-service (TIS);
or
    (2) Has had either main wing spar replaced with a serviceable
(more than zero hours TIS) main wing spar; or
    (3) Has missing and/or incomplete maintenance records.
BILLING CODE 4910-13-P

[GRAPHIC] [TIFF OMITTED] TR15JA21.014

BILLING CODE 4910-13-C

(d) Subject

    Joint Aircraft System Component (JASC) Code 5711, Wing Spar.

(e) Unsafe Condition

    This AD was prompted by a report of a wing separation caused by
fatigue cracking in a visually inaccessible area of the main wing
lower spar cap. The FAA is issuing this AD to detect and correct
fatigue cracks in the lower main wing spar cap bolt holes. The
unsafe condition, if not addressed, could result in the wing
separating from the fuselage in flight.

(f) Compliance

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

(g) Definitions

    (1) ``TIS'' has the same meaning as the definition of ``time in
service'' in 14 CFR
    1.1.
    (2) For purposes of this AD, ``factored service hours'' refers
to the calculated quantity of hours using the formula in paragraph
(h)(2) of this AD, which accounts for the usage history of the
airplane.

(h) Review Airplane Maintenance Records and Calculate Factored Service
Hours for Each Main Wing Spar

    (1) Within 30 days after the effective date of this AD, review
the airplane maintenance records and determine the number of 100-
hour inspections completed on the airplane since new and any record
of wing spar replacement(s).
    (i) For purposes of this review, count any inspection conducted
to comply with the 100-hour requirement of 14 CFR 91.409(b)
pertaining to carrying persons for hire, such as in-flight training
environments, even if the inspection was entered in the maintenance
records as an ``annual'' inspection or as an ``annual/100-hour''
inspection. If the purpose of an inspection was to comply with Sec.
91.409(b), then it must be counted. To determine the purpose of an
inspection, note the repeating intervals between inspections, i.e.,
less than 10 months between, and typically 90-110 flight hours. An
inspection entered as a ``100-hour'' inspection but done solely for
the purpose of meeting the requirement to complete an annual
inspection, or those otherwise not required by Sec.  91.409(b), need
not be counted. For operators utilizing a progressive inspection
program, count the completion of each Sec.  91.409(b) 100-hour
interval as one inspection.
    (ii) If a main wing spar has been replaced with a new (zero
hours TIS) main wing spar, count the number of 100-hour inspections
from the time of installation of the new main wing spar.

    (iii) If a main wing spar has been replaced with a serviceable
main wing spar (more than zero hours TIS) or the airplane
maintenance records are missing or incomplete, the wing history
cannot be determined. Perform the eddy current inspection as
specified in paragraph (i) of this AD.
    (iv) The actions required by paragraph (h)(1) of this AD may be
performed by the owner/operator (pilot) holding at least a private
pilot certificate and must be entered into the aircraft records
showing compliance with this AD in accordance with 14 CFR 43.9(a)(1)
through (4), and 14 CFR 91.417(a)(2)(v). The record must be
maintained as required by 14 CFR 91.417, 121.380, or 135.439.
    (2) Before further flight after completing the action in
paragraph (h)(1) of this AD, calculate the factored service hours
for each main wing spar using the formula in figure 1 to paragraph
(h)(2) of this AD. Thereafter, after each annual inspection and 100-
hour inspection, recalculate/update the factored service hours for
each main wing spar until the main wing spar has accumulated 5,000
or more factored service hours.
BILLING CODE 4910-13-P
[GRAPHIC] [TIFF OMITTED] TR15JA21.015

    (3) An example of determining factored service hours for an
airplane with no 100-hour inspections is as follows: The airplane
maintenance records show that the airplane has a total of 12,100
hours TIS, and only annual inspections have been done. None of the
annual inspections were done for purposes of compliance with Sec.
91.409(b). Both main wing spars are original factory installed. In
this case, N = 0 and T = 12,100. Use those values in the formula as
shown in figure 2 to paragraph (h)(3) of this AD. In the example in
figure 2 to paragraph (h)(3) of this AD), the eddy current
inspection would not be required because the factored service hours
are less than 5,000 hours.
[GRAPHIC] [TIFF OMITTED] TR15JA21.016

BILLING CODE 4910-13-C
    (4) An example of determining factored service hours for an
airplane with both 100-hour and annual inspections is as follows:
The airplane was originally flown for personal use, then for
training for a period of time, then returned to personal use. The
airplane maintenance records show that the airplane has a total of
10,600 hours TIS, and fifty-five 100-hour inspections for purposes
of compliance with Sec.  91.409(b) have been done. Both main wing
spars are original factory installed. In this case, N = 55 and T =
10,600. Use those values in the formula shown in figure 3 to
paragraph (h)(4) of this AD. First, calculate commercial use time by
multiplying (N x 100). Next, subtract that time from the total time,
and divide that quantity by 17. Add the two quantities to determine
total factored service hours. In the example in figure 3 to
paragraph (h)(4) of this AD), the eddy current inspection would be
required because the factored service hours are more than 5,000
hours.

[GRAPHIC] [TIFF OMITTED] TR15JA21.017

(i) Eddy Current Inspect

    Within the compliance time specified in either paragraph (i)(1)
or (2) of this AD, as applicable, eddy current inspect the inner
surface of the two lower outboard bolt holes on the lower main wing
spar cap for cracks. If the wing is installed, use steps 1 through 3
or, if the wing is not installed, use step 3 in the Instructions of
Piper Aircraft, Inc. Service Bulletin No. 1345, dated March 27, 2020
(Piper SB No. 1345). Although Piper SB No. 1345 specifies NAS 410
Level II or Level III certification to perform the inspection, this
AD allows Level II or Level III qualification standards for
inspection personnel using any inspector criteria approved by the
FAA.
    Note 2 to the introductory text of paragraph (i): Advisory
Circular 65-31B contains FAA-approved Level II and Level III
qualification standards criteria for inspection personnel doing
nondestructive test (NDT) inspections.
    (1) Within 100 hours TIS after complying with paragraph (h) of
this AD or within 100 hours TIS after a main wing spar accumulates
5,000 factored service hours, whichever occurs later; or
    (2) For airplanes with an unknown number of factored service
hours on a main wing spar, within the next 100 hours TIS after the
effective date of this AD or within 60 days after the effective date
of this AD, whichever occurs later.

(j) Replace the Main Wing Spar

    If a crack is found during an inspection required by paragraph
(i) of this AD, before further flight, replace the main wing spar
with a new (zero hours TIS) main wing spar or with a serviceable
(more than zero hours TIS) main wing spar that has passed the eddy
current inspection required by paragraph (i) of this AD.

(k) Install New Bolts

    Before further flight after completing the actions required by
paragraph (i) or (j) of this AD, install new bolts by following step
6 of Piper Aircraft, Inc. Service Bulletin No. 1345, dated March 27,
2020.

(l) Report Inspection Results

    Within 30 days after completing an inspection required by
paragraph (i) of this AD, using Appendix 1, ``Inspection Results
Form,'' of this AD, report the inspection results to the FAA at the
Atlanta ACO Branch and to Piper Aircraft. Submit the report to the
FAA and Piper using the contact information found on the form in
appendix 1 of this AD.

(m) Special Flight Permit

    A special flight permit may only be issued to operate the
airplane to a location where the inspection requirement of paragraph
(i) of this AD can be performed. This AD prohibits a special flight
permit if the inspection reveals a crack in a main wing spar.

(n) Paperwork Reduction Act Burden Statement

    A federal agency may not conduct or sponsor, and a person is not
required to respond to, nor shall a person be subject to a penalty
for failure to comply with a collection of information subject to
the requirements of the Paperwork Reduction Act unless that
collection of information displays a currently valid OMB Control
Number. The OMB Control Number for this information collection is
2120-0056. Public reporting for this collection of information is
estimated to be approximately 1 hour per response, including the
time for reviewing instructions, searching existing data sources,
gathering and maintaining the data needed, completing and reviewing
the collection of information. All responses to this collection of
information are mandatory. Send comments regarding this burden
estimate or any other aspect of this collection of information,
including suggestions for reducing this burden to: Information
Collection Clearance Officer, Federal Aviation Administration, 10101
Hillwood Parkway, Fort Worth, TX 76177-1524.

(o) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Atlanta ACO Branch, 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 certification office, send it to the attention of the
person identified in paragraph (p) of this AD.
    (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.

(p) Related Information

    For more information about this AD, contact Dan McCully,
Aviation Safety Engineer, Atlanta ACO Branch, FAA, 1701 Columbia
Avenue, College Park, Georgia 30337; phone:<PHONE_NUMBER>; fax:
(404) 474-5605; email<EMAIL_ADDRESS>
(q) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference of the service information listed in this
paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless the AD specifies otherwise.
    (i) Piper Service Bulletin No. 1345, dated March 27, 2020.
    (ii) [Reserved]
    (3) For Piper Aircraft, Inc. service information identified in
this AD, contact Piper Aircraft, Inc., 2926 Piper Drive, Vero

Beach, Florida 32960; phone:<PHONE_NUMBER>; website: https://www.piper.com.
    (4) You may view this service information at FAA, Airworthiness
Products Section, Operational Safety Branch, 901 Locust, Kansas
City, Missouri 64106. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>.
    (5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, email<EMAIL_ADDRESS>or go to: https://www.archives.gov/federal-register/cfr/ibr-locations.html.
BILLING CODE 4910-13-P

[GRAPHIC] [TIFF OMITTED] TR15JA21.018

BILLING CODE 4910-13-C

    Issued on December 30, 2020.
Gaetano A. Sciortino,
Deputy Director for Strategic Initiatives, Compliance & Airworthiness
Division, Aircraft Certification Service.
[FR Doc. 2021-00044 Filed 1-14-21; 8:45 am]
BILLING CODE 4910-13-C


[Federal Register Volume 79, Number 186 (Thursday, September 25, 2014)]
[Notices]
[Pages 57560-57561]
[FR Doc No: 2014-22807]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2014-M-0326, FDA-2013-M-1324, FDA-2013-M-1693, FDA-
2014-M-0069, FDA-2014-M-0166, FDA-2014-M-0167, FDA-2014-M-0224, and
FDA-2014-M-0254]

Medical Devices; Availability of Safety and Effectiveness
Summaries for Premarket Approval Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is publishing a list of
premarket approval applications (PMAs) that have been approved. This
list is intended to inform the public of the availability of safety and
effectiveness summaries of approved PMAs through the Internet and the
Agency's Division of Dockets Management.

ADDRESSES: Submit written requests for copies of summaries of safety
and effectiveness data to the Division of Dockets Management (HFA-305),
Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852. Please cite the appropriate docket number as listed in table
1 when submitting a written request. See the SUPPLEMENTARY INFORMATION
section for electronic access to the summaries of safety and
effectiveness.

FOR FURTHER INFORMATION CONTACT: Nicole Wolanski, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 1650, Silver Spring, MD 20993-0002, 301-
796-6570.

SUPPLEMENTARY INFORMATION:

I. Background

    In accordance with sections 515(d)(4) and (e)(2) of the Federal
Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360e(d)(4) and
(e)(2)), notification of an order approving, denying, or withdrawing
approval of a PMA will continue to include a notice of opportunity to
request review of the order under section 515(g) of the FD&C Act. The
30-day period for requesting reconsideration of an FDA action under
Sec.  10.33(b) (21 CFR 10.33(b)) for notices announcing approval of a
PMA begins on the day the notice is placed on the Internet. Section
10.33(b) provides that FDA may, for good cause, extend this 30-day
period. Reconsideration of a denial or withdrawal of approval of a PMA
may be sought only by the applicant; in these cases, the 30-day period
will begin when the applicant is notified by FDA in writing of its
decision.
    The regulations provide that FDA publish a quarterly list of
available safety and effectiveness summaries of PMA approvals and
denials that were announced during that quarter. The following is a
list of approved PMAs for which summaries of safety and effectiveness
were placed on the Internet from January 1, 2014, through March 31,
2014, and includes one denial action during this period. The list
provides the manufacturer's name, the product's generic name or the
trade name, and the approval date.

   Table 1--List of Safety and Effectiveness Summaries for Approved PMAs Made Available From January 1, 2014,
                                             Through March 31, 2014
----------------------------------------------------------------------------------------------------------------
         PMA No., Docket No.                  Applicant                Trade name             Date of action
----------------------------------------------------------------------------------------------------------------
P070023, FDA-2013-M-1324.............  Fzio Med, Inc..........  Oxiplex[reg]/SP Gel....  Denied October 21,
                                                                                2013.
P110016/S008, FDA-2013-M-1693........  St. Jude Medical, Inc..  Therapy Cool Flex        Approved December 18,
                                                                 Ablation Catheter.       2013.
P130004, FDA-2014-M-0069.............  Ocular Therapeutics,     ReSure[reg] Sealant....  Approved January 8,
                                        Inc.                                              2014.
P130021, FDA-2014-M-0166.............  Medtronic CoreValve LLC  Medtronic CoreValveTM    Approved January 17,
                                                                 System.                  2014.
P100040/S012, FDA-2014-M-0167........  Medtronic Vascular.....  Valiant Thoracic Stent   Approved January 22,
                                                                 Graft with Captivia      2014.
                                                                 Delivery System.
P120005/S002, FDA-2014-M-0224........  Dexcom, Inc............  Dexcom G4 PLATINUM       Approved February 3,
                                                                 (Pediatric) Continuous   2014.
                                                                 Glucose Monitoring
                                                                 System.

P090031, FDA-2014-M-0254.............  Anika Therapeutics, Inc  MONOVISCTM Injectable    Approved February 25,
                                                                 Intra-articular Device.  2014.
P130015, FDA-2013-M-0326.............  Roche Diagnostics        Elecsys[reg] HBeAg       Approved March 14,
                                        Operations, Inc.         Immunoassay and          2014.
                                                                 Elecsys[reg]
                                                                 PreciControl HBeAg.
----------------------------------------------------------------------------------------------------------------

II. Electronic Access

    Persons with access to the Internet may obtain the documents at
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/PMAApprovals/default.htm.

    Dated: September 19, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-22807 Filed 9-24-14; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 86, Number 205 (Wednesday, October 27, 2021)]
[Notices]
[Page 59376]
[FR Doc No: 2021-23369]

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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OAR-2006-0947; FRL-9198-01-OMS]

Information Collection Request Submitted to OMB for Review and
Approval; Comment Request; NOX SIP Call (Renewal)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: The Environmental Protection Agency (EPA) has submitted an
information collection request (ICR), NOX SIP Call (EPA ICR
Number 1857.12, OMB Control Number 2060-0445) to the Office of
Management and Budget (OMB) for review and approval in accordance with
the Paperwork Reduction Act. This is a proposed extension of the ICR,
which is currently approved through December 31, 2021. Public comments
were previously requested via the Federal Register on April, 6, 2021
during a 60-day comment period. This notice allows for an additional 30
days for public comments. A fuller description of the ICR is given
below, including its estimated burden and cost to the public. An agency
may not conduct or sponsor and a person is not required to respond to a
collection of information unless it displays a currently valid OMB
control number.

DATES: Additional comments may be submitted on or before November 26,
2021.

ADDRESSES: Submit your comments, referencing Docket ID Number EPA-HQ-
OAR-2006-0947, online using www.regulations.gov (our preferred method)
or by mail to: EPA Docket Center, Environmental Protection Agency, Mail
Code 28221T, 1200 Pennsylvania Ave. NW, Washington, DC 20460.
    EPA's policy is that all comments received will be included in the
public docket without change including any personal information
provided, unless the comment includes profanity, threats, information
claimed to be Confidential Business Information (CBI), or other
information whose disclosure is restricted by statute.
    Submit written comments and recommendations to OMB for the proposed
information collection within 30 days of publication of this notice to
www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under 30-day Review--Open for
Public Comments'' or by using the search function.

FOR FURTHER INFORMATION CONTACT: Karen VanSickle, Clean Air Markets
Division, Office of Atmospheric Programs (6204J), Environmental
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460;
telephone number:<PHONE_NUMBER>; fax number:<PHONE_NUMBER>; email
address: [email protected].

SUPPLEMENTARY INFORMATION: Supporting documents which explain in detail
the information that the EPA will be collecting are available in the
public docket for this ICR. The docket can be viewed online at
www.regulations.gov or in person at the EPA Docket Center, WJC West,
Room 3334, 1301 Constitution Ave. NW, Washington, DC. The telephone
number for the Docket Center is<PHONE_NUMBER>. For additional
information about EPA's public docket, visit http://www.epa.gov/dockets.
    Abstract: The NOX SIP Call was created to reduce
emissions of nitrogen oxides (NOX) from power plants and
other large combustion sources. NOX is a prime ingredient in
the formation of ground-level ozone (smog), a pervasive air pollution
problem in many areas of the eastern United States. The NOX
SIP Call requires affected states to include certain provisions in
their state implementation plans (SIPs) addressing emissions of
NOX that adversely affect air quality in other states.
Although most large combustion sources affected under the
NOX SIP Call are also subject to monitoring requirements
under the Acid Rain Program or the Cross-State Air Pollution Rule, this
information collection is being renewed because some industrial sources
in certain states are still required to monitor and report emissions
data to EPA under these rules, so we will account for their burden. All
data received by EPA will be treated as public information. The OMB
control numbers for EPA's regulations in 40 CFR are listed in 40 CFR
part 9.
    Form Numbers: None.
    Respondents/affected entities: Entities which participate in the
NOX SIP Call.
    Respondent's obligation to respond: mandatory (Sections 110(a) and
301(a) of the Clean Air Act).
    Estimated number of respondents: EPA estimates that there are 356
units that will continue to conduct monitoring solely under the
NOX SIP Call.
    Frequency of response: yearly, quarterly, occasionally.
    Total estimated burden: 140,226 hours (per year). Burden is defined
at 5 CFR 1320.03(b).
    Total estimated cost: $20,622,606 (per year), includes $9,194,261
annualized capital or operation & maintenance costs.
    Changes in the estimates: There is increase of 8,281 hours in the
total estimated respondent burden compared with the ICR currently
approved by OMB. This increase is due to assumptions made in the
previous ICR regarding the number of respondents. In the previous ICR,
EPA estimated fewer sources would continue to follow the Part 75
monitoring requirements due to amendments to the NOX SIP
Call. This ICR is based on updated information regarding the actual
numbers of sources.

Courtney Kerwin,
Director, Regulatory Support Division.
[FR Doc. 2021-23369 Filed 10-26-21; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 80, Number 64 (Friday, April 3, 2015)]
[Notices]
[Pages 18235-18238]
[FR Doc No: 2015-07605]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-0001]

Request for Nominations for Individuals and Consumer
Organizations for Advisory Committees

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is requesting that any
consumer organizations interested in participating in the selection of
voting and/or nonvoting consumer representatives to serve on its
advisory committees or panels notify FDA in writing. FDA is also
requesting nominations for voting and/or nonvoting consumer
representatives to serve on advisory committees and/or panels for which
vacancies currently exist or are expected to occur in the near future.
Nominees recommended to serve as a voting or nonvoting consumer
representative may be self-nominated or may be nominated by a consumer
organization. Nominations will be accepted for current vacancies and
for those that will or may occur through September 30, 2015.

DATES: Any consumer organization interested in participating in the
selection of an appropriate voting or nonvoting member to represent
consumer interests on an FDA advisory committee or panel may send a
letter or email stating that interest to the FDA (see ADDRESSES) by May
4, 2015, for vacancies listed in this notice. Concurrently, nomination
materials for prospective candidates should be sent to FDA (see
ADDRESSES) by May 4, 2015.

ADDRESSES: All statements of interest from consumer organizations
interested in participating in the selection process and consumer
representative nominations should submit your information
electronically to

<EMAIL_ADDRESS>or by mail to Advisory Committee
Oversight and Management Staff, 10903 New Hampshire Ave., Bldg. 32, Rm.
5103, Silver Spring, MD 20993-0002, or FAX:<PHONE_NUMBER>.
    Consumer Representative nominations should be submitted
electronically by logging into the FDA advisory Committee Membership
Nomination Portal: https://www.accessdata.fda.gov/scripts/FACTRSPortal/FACTRS/index.cfm or by mail to Advisory Committee Oversight and
Management Staff, 10903 New Hampshire Ave., Bldg. 32, Rm. 5103, Silver
Spring, MD 20993-0002, or FAX:<PHONE_NUMBER>. Additional information
about becoming a member on an FDA advisory committee can also be
obtained by visiting FDA's Web site at http://www.fda.gov/AdvisoryCommittees/default.htm.

FOR FURTHER INFORMATION CONTACT: Kimberly Hamilton, Advisory Committee
Oversight and Management Staff, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 32, Rm. 5117, Silver Spring, MD 20993-0002;. 301-
796-8224, email<EMAIL_ADDRESS>    For questions relating to specific advisory committees or panels,
contact the following persons listed in table 1 of this document:

                  Table 1--Advisory Committee Contacts
------------------------------------------------------------------------
                Contact person                      Committee/Panel
------------------------------------------------------------------------
Janie Kim, Center for Biologics Evaluation     Allergenic Products
 and Research, Food and Drug Administration,    Advisory Committee.
 10903 New Hampshire Ave., Bldg. 71, Rm.
 6129, Silver Spring, MD 20993;<PHONE_NUMBER>,
 email<EMAIL_ADDRESS>Stephanie Begansky, Center for Drug            Arthritis Advisory
 Evaluation and Research, Division of           Committee.
 Advisory Committee and Consultant
 Management, Office of Executive Programs,
 10903 New Hampshire Ave., Bldg. 31, Rm.
 2426, Silver Spring, MD 20993-0002; 301-796-
 3693, FAX:<PHONE_NUMBER>, email:
<EMAIL_ADDRESS>Jamie Waterhouse, Center for Devices and       Circulatory System
 Radiological Health, Office of Device          Devices Panel, Molecular
 Evaluation, 10903 New Hampshire Ave., Bldg.    and Clinical Genetics
 66, Rm. 1544, Silver Spring, MD 20993-0002;    Panel.
<PHONE_NUMBER>, FAX:<PHONE_NUMBER>, email:
<EMAIL_ADDRESS>Yvette Waples, Center for Drug Evaluation &    Dermatologic and
 Research, Division of Advisory Committee and   Ophthalmic Drugs
 Consultant Management, Office of Executive     Advisory Committee.
 Programs, 10993 New Hampshire Ave., Bldg.
 31, Rm. 2510, Silver Spring, MD 20993-0002;
<PHONE_NUMBER> FAX:<PHONE_NUMBER> email:
<EMAIL_ADDRESS>Patricio Garcia, Center for Devices and        General and Plastic
 Radiological Health, Office of Device          Surgery Devices Panel.
 Evaluation, 10903 New Hampshire Ave., Bldg.
 66, Rm. RMG 465 HFZ-410, Silver Spring, MD
 20903-0002,<PHONE_NUMBER>, FAX:<PHONE_NUMBER>,
 email<EMAIL_ADDRESS>Sara J. Anderson, Center for Devices and       Hematology & Pathology
 Radiological Health, Office of Device          Devices Panel,
 Evaluation, 10903 New Hampshire Ave., Bldg.    Orthopaedic and
 66, Rm. 1544, Silver Spring, MD 20903-0002;    Rehabilitation Devices
<PHONE_NUMBER>, FAX:<PHONE_NUMBER>, email:        Panel, and National
<EMAIL_ADDRESS>                    Mammography and Quality
                                                Assurance Advisory
                                                Committee.
Shanika Craig, Food and Drug Administration,   Obstetrics and Gynecology
 10903 New Hampshire Ave., Bldg. 66 Rm. 1613,   Devices Panel.
 Silver Spring, MD 20993-0002;<PHONE_NUMBER>,
 FAX:<PHONE_NUMBER>, email:
<EMAIL_ADDRESS>Lauren Tesh, Center for Drug Evaluation and    Oncologic Drugs Advisory
 Research, 10903 New Hampshire Ave., Bldg.      Committee.
 31, Rm. 2426, Silver Spring, MD 20993-0002;
<PHONE_NUMBER>, email<EMAIL_ADDRESS>Donna Mendrick, National Center for            Science Advisory Board to
 Toxicological Research, Bldg. 32, Rm. 2208,    National Center for
 10903 New Hampshire Ave., Silver Spring, MD    Toxicological Research
 20993-0002,<PHONE_NUMBER>, FAX:<PHONE_NUMBER>,   (NCTR).
 email<EMAIL_ADDRESS>Sujata Vijh, Center for Biologics Evaluation   Vaccines and Related
 and Research, Division of Scientific           Biological Products
 Advisors and Consultants, 10903 New            Advisory Committee.
 Hampshire Ave., Silver Spring, MD 20993-
 0002;<PHONE_NUMBER>, FAX:<PHONE_NUMBER>,
 email<EMAIL_ADDRESS>------------------------------------------------------------------------

SUPPLEMENTARY INFORMATION: FDA is requesting nominations for voting
and/or nonvoting consumer representatives for the vacancies listed in
Table 2:

             Table 2--Committee Descriptions, Type of Consumer Vacancy, and Approximate Date Needed
----------------------------------------------------------------------------------------------------------------
  Committee/Panel/Areas of expertise
                needed                     Current and upcoming vacancies          Approximate date needed
----------------------------------------------------------------------------------------------------------------
Allergenic Products Advisory            One Voting.........................  June 30, 2015.
 Committee: Knowledgeable in the
 fields of allergy, immunology,
 pediatrics, internal medicine,
 biochemistry, and related specialties.
Arthritis Drugs Advisory Committee:     One Voting.........................  September 30, 2015.
 Knowledgeable in the fields of
 arthritis, rheumatology, orthopedics,
 epidemiology or statistics,
 analgesics, and related specialties.
Circulatory System Devices Panel of     One Non-Voting.....................  Immediately.
 the Medical Devices Advisory
 Committee: Knowledgeable in the
 safety and effectiveness of marked
 and investigational devices for use
 in the circulatory and vascular
 systems.
Dermatologic & Ophthalmic Drugs         One Voting.........................  August 31, 2015.
 Advisory Committee: Knowledgeable in
 the fields of dermatology,
 ophthalmology, internal medicine,
 pathology, immunology, epidemiology
 or statistics, and other related
 professions.
General and Plastic Surgery Devices     One Non-Voting.....................  Immediately.
 Panel of the Medical Devices Advisory
 Committee: Knowledgeable in the
 fields of general, plastic,
 reconstructive, pediatric, thoracic,
 abdominal, pelvic and endoscopic
 surgery; biomaterials, lasers, wound
 healing, and quality of life issues.

Hematology and Pathology Devices Panel  One Non-Voting.....................  Immediately.
 of the Medical Devices Advisory
 Committee: Knowledgeable in the
 fields of hematology,
 hematopathology, coagulation and
 homeostasis, hematological oncology,
 gynecological oncology.
Molecular & Clinical Genetics Panel of  One Non-Voting.....................  May 31, 2015.
 the Medical Devices Advisory
 Committee: Experts in human genetics
 and in the clinical management of
 patients with genetic disorders,
 e.g., pediatricians, obstetricians,
 neonatologists. The Agency is also
 interested in considering candidates
 with training in inborn errors of
 metabolism, biochemical and/or
 molecular genetics, population
 genetics, epidemiology and related
 statistical training. Additionally,
 individuals with experience in
 genetic counseling, medical ethics as
 well as ancillary fields of study
 will be considered.
Obstetrics and Gynecology Devices       One Non-Voting.....................  Immediately.
 Panel of the Medical Devices Advisory
 Committee: Knowledgeable in the
 fields of perinatology, embryology,
 reproductive endocrinology, pediatric
 gynecology, gynecological oncology,
 operative hysteroscopy, pelviscopy,
 electrosurgery, laser surgery,
 assisted reproductive technologies,
 contraception, postoperative
 adhesions, and cervical cancer and
 colposcopy; obstetrics/gynecology
 devices; gynecology in the older
 patient; midwifery; labor and
 delivery nursing.
Oncologic Drugs Advisory Committee:     One Voting.........................  Immediately.
 Knowledgeable in the fields of
 general oncology, pediatric oncology,
 hematologic oncology, immunologic
 oncology, biostatistics, and other
 related professions.
National Mammography Quality Assurance  Two Voting.........................  Immediately.
 Advisory Committee: Knowledgeable in
 clinical practice, research
 specialization, or professional work
 that has a significant focus on
 mammography.
Orthopaedic and Rehabilitation Devices  Two Non-Voting.....................  Immediately.
 Panel of the Medical Devices Advisory
 Committee: Knowledgeable in data
 concerning the safety and
 effectiveness of marketed and
 investigational orthopaedic and
 rehabilitation devices.
Science Advisory Board to the NCTR:     One Voting.........................  June 30, 2015.
 Knowledgeable in the fields related
 to toxicological research.
Vaccines and Related Biological         One Voting.........................  Immediately.
 Products Advisory Committee
 Knowledgeable in the fields of
 immunology, molecular biology, rDNA,
 virology, bacteriology, epidemiology
 or biostatistics, allergy, preventive
 medicine, infectious diseases,
 pediatrics, microbiology, and
 biochemistry.
----------------------------------------------------------------------------------------------------------------

I. Functions

    A. Allergenic Products Advisory Committee: Reviews and evaluates
available data concerning the safety, effectiveness, and adequacy of
labeling of marketed and investigational allergenic biological products
or materials that are administered to humans for the diagnosis,
prevention, or treatment of allergies and allergic disease as well as
the affirmation or revocation of biological product licenses, on the
safety, effectiveness, and labeling of the products, on clinical and
laboratory studies of such products, on amendments or revisions to
regulations governing the manufacture, testing and licensing of
allergenic biological products, and on the quality and relevance of
FDA's research programs.
    B. Arthritis Drugs Advisory Committee: Reviews and evaluates data
concerning the safety and effectiveness of marketed and investigational
human drug products for use in the treatment of arthritis, rheumatism,
and related diseases.
    C. Certain Panels of the Medical Devices Advisory Committee: The
committee reviews and evaluates data on the safety and effectiveness of
marketed and investigational devices and makes recommendations for
their regulation. The panels engage in a number of activities to
fulfill the functions the Federal Food, Drug, and Cosmetic Act (the
FD&C Act) envisions for device advisory panels. With the exception of
the Medical Devices Dispute Resolution Panel, each panel, according to
its specialty area, advises the Commissioner of Food and Drugs (the
Commissioner) regarding recommended classification or reclassification
of devices into one of three regulatory categories, advises on any
possible risks to health associated with the use of devices, advises on
formulation of product development protocols, reviews premarket
approval applications for medical devices, reviews guidelines and
guidance documents, recommends exemption of certain devices from the
application of portions of the FD&C Act, advises on the necessity to
ban a device, and responds to requests from the Agency to review and
make recommendations on specific issues or problems concerning the
safety and effectiveness of devices. With the exception of the Medical
Devices Dispute Resolution Panel, each panel, according to its
specialty area, may also make appropriate recommendations to the
commissioner on issues relating to the design of clinical studies
regarding the safety and effectiveness of marketed and investigational
devices.
    D. Dermatologic and Ophthalmic Drugs Advisory Committee: Reviews
and evaluates available data concerning the safety and effectiveness of
marketed and investigational human drug products for use in the
treatment of dermatologic and ophthalmic disorders.
    E. National Mammography and Quality Assurance Advisory Committee:
The committee reviews and evaluates (1) Developing appropriate quality
standards and regulations for mammography facilities; (2) developing
appropriate standards and regulations for bodies accrediting
mammography facilities under this program; (3) developing regulations
with respect to sanctions; (4) developing procedures for monitoring
compliance with standards; (5) establishing a mechanism to investigate
consumer complaints; (6) reporting new developments concerning breast
imaging which should be considered in the oversight of mammography
facilities; (7) determining whether there exists a shortage of
mammography facilities in rural and health professional shortage areas
and determining the effects of personnel on access to the services of
such facilities in such areas; (8) determining whether there will exist
a sufficient number of medical physicists after October 1, 1999; and
(9) determining the costs and benefits of compliance with these
requirements.
    F. Oncologic Drugs Advisory Committee: Reviews and evaluates data
concerning the safety and effectiveness

of marketed and investigational human drug products for use in the
treatment of cancer.
    G. Science Advisory Board to the National Center for Toxicological
Research: Reviews and advises the Agency on the establishment,
implementation and evaluation of the research programs and regulatory
responsibilities as it relates to NCTR. The Board will also provide an
extra-Agency review in ensuring that the research programs at NCTR are
scientifically sound and pertinent.
    H. Vaccines and Related Biological Products Advisory Committee:
Reviews and evaluates data concerning the safety, effectiveness, and
appropriate use of vaccines and related biological products which are
intended for use in the prevention, treatment, or diagnosis of human
diseases, as well as considers the quality and relevance of FDA's
research program which provides scientific support for the regulation
of these products.

II. Criteria for Members

    Persons nominated for membership as consumer representatives on
committees or panels should meet the following criteria: (1)
Demonstrate ties to consumer and community-based organizations, (2) be
able to analyze technical data, (3) understand research design, (4)
discuss benefits and risks, and (5) evaluate the safety and efficacy of
products under review. The consumer representative should be able to
represent the consumer perspective on issues and actions before the
advisory committee; serve as a liaison between the committee and
interested consumers, associations, coalitions, and consumer
organizations; and facilitate dialogue with the advisory committees on
scientific issues that affect consumers.

III. Selection Procedures

    Selection of members representing consumer interests is conducted
through procedures that include the use of organizations representing
the public interest and public advocacy groups. These organizations
recommend nominees for the Agency's selection. Representatives from the
consumer health branches of Federal, State, and local governments also
may participate in the selection process. Any consumer organization
interested in participating in the selection of an appropriate voting
or nonvoting member to represent consumer interests should send a
letter stating that interest to FDA (see ADDRESSES) within 30 days of
publication of this document.
    Within the subsequent 30 days, FDA will compile a list of consumer
organizations that will participate in the selection process and will
forward to each such organization a ballot listing at least two
qualified nominees selected by the Agency based on the nominations
received, together with each nominee's current curriculum vitae or
resume. Ballots are to be filled out and returned to FDA within 30
days. The nominee receiving the highest number of votes ordinarily will
be selected to serve as the member representing consumer interests for
that particular advisory committee or panel.

IV. Nomination Procedures

    Any interested person or organization may nominate one or more
qualified persons to represent consumer interests on the Agency's
advisory committees or panels. Self-nominations are also accepted.
Nominations should include a cover letter and a current curriculum
vitae or resume for each nominee, including a current business and/or
home address, telephone number, and email address if available, and a
list of consumer or community-based organizations for which the
candidate can demonstrate active participation. FDA seeks to include
the views of women and men, members of all racial and ethnic groups,
and individuals with and without disabilities on its advisory
committees and therefore, encourages nominations of appropriately
qualified candidates from these groups.
    Nominations should also specify the advisory committee(s) or
panel(s) for which the nominee is recommended. In addition, nominations
should include confirmation that the nominee is aware of the
nomination, unless self-nominated. FDA will ask potential candidates to
provide detailed information concerning such matters as financial
holdings, employment, and research grants and/or contracts to permit
evaluation of possible sources of conflicts of interest. Members will
be invited to serve for terms up to 4 years.
    FDA will review all nominations received within the specified
timeframes and prepare a ballot containing the names of qualified
nominees. Names not selected will remain on a list of eligible nominees
and be reviewed periodically by FDA to determine continued interest.
Upon selecting qualified nominees for the ballot, FDA will provide
those consumer organizations that are participating in the selection
process with the opportunity to vote on the listed nominees. Only
organizations vote in the selection process. Persons who nominate
themselves to serve as voting or nonvoting consumer representatives
will not participate in the selection process.

    Dated: March 30, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-07605 Filed 4-2-15; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 84, Number 85 (Thursday, May 2, 2019)]
[Notices]
[Pages 18839-18840]
[FR Doc No: 2019-08907]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 13629-002]

Notice of Effectiveness of Withdrawal of License Application:
Coleman Hydro LLC

    On April 22, 2011, Coleman Hydro LLC (Coleman) filed a license
application for an original minor license to construct and operate its
proposed Coleman Hydroelectric Project No. 13629. The Commission issued
a notice on April 1, 2019 that informed Coleman that its proposed LTC
Hydro Project located at the same proposed site meets the qualifying
conduit hydropower facility criteria and to withdraw its pending
license application if it intends to pursue the project as a qualifying
conduit hydropower facility. On April 9, 2019, Coleman filed a letter
informing the Commission that it was withdrawing its minor license
application for the project.
    No motion in opposition to the notice of withdrawal has been filed,
and the Commission has taken no action to disallow the withdrawal.
Pursuant to Rule 216(b) of the Commission's Rules of Practice and
Procedure, the withdrawal of the application became

effective on April 24, 2019 and this proceeding is hereby
terminated.\1\
---------------------------------------------------------------------------

    \1\ 18 CFR 385.216(b) (2018).

    Dated: April 26, 2019.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2019-08907 Filed 5-1-19; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 86, Number 231 (Monday, December 6, 2021)]
[Rules and Regulations]
[Pages 68907-68910]
[FR Doc No: 2021-26334]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2021-0720; Project Identifier 2019-SW-079-AD; Amendment
39-21808; AD 2021-23-10]
RIN 2120-AA64

Airworthiness Directives; Leonardo S.p.a Helicopters

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: The FAA is adopting a new airworthiness directive (AD) for
certain Leonardo S.p.a. Model AW109SP helicopters. This AD was prompted
by reports of an ineligible hydraulic pump being installed on Model
AW109SP helicopters. This AD requires inspecting each hydraulic pump
for damage and, depending on the inspections results,

removing parts from service and accomplishing other corrective actions.
This AD also requires removing certain parts from service before they
exceed their life limits. The corrective actions are required to be
accomplished as specified in a European Union Aviation Safety Agency
(EASA) AD, which is incorporated by reference. The FAA is issuing this
AD to address the unsafe condition on these products.

DATES: This AD is effective February 4, 2022.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of January 10,
2022.

ADDRESSES: For material incorporated by reference (IBR) in this AD,
contact the EASA, Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany;
telephone +49 221 8999 000; email [email protected]; internet
www.easa.europa.eu. You may find this material on the EASA website at
https://ad.easa.europa.eu. You may view this material at the FAA,
Office of the Regional Counsel, Southwest Region, 10101 Hillwood Pkwy.,
Room 6N-321, Fort Worth, TX 76177. For information on the availability
of this material at the FAA, call<PHONE_NUMBER>. It is also available
in the AD docket at https://www.regulations.gov by searching for and
locating Docket No. FAA-2021-0720.

Examining the AD Docket

    You may examine the AD docket at https://www.regulations.gov by
searching for and locating Docket No. FAA-2021-0720; or in person at
Docket Operations between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays. The AD docket contains this final rule, the
EASA AD, any comments received, and other information. The address for
Docket Operations is 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: Darren Gassetto, Aerospace Engineer,
COS Program Management Section, Operational Safety Branch, Compliance &
Airworthiness Division, FAA, 1600 Stewart Ave., Suite 410, Westbury, NY
11590; telephone<PHONE_NUMBER>; email [email protected].

SUPPLEMENTARY INFORMATION:

Background

    EASA, which is the Technical Agent for the Member States of the
European Union, has issued EASA AD 2019-0213, dated August 29, 2019
(EASA AD 2019-0213), to correct an unsafe condition for Leonardo S.p.a.
(formerly Finmeccanica S.p.A. Helicopter Division, AgustaWestland
S.p.A, Agusta S.p.A.) Model AW109SP helicopters.
    The FAA issued a notice of proposed rulemaking (NPRM) to amend 14
CFR part 39 by adding an AD that would apply to certain Leonardo S.p.a.
Model AW109SP helicopters. The NPRM published in the Federal Register
on September 8, 2021 (86 FR 50289). The NPRM was prompted by reports of
a hydraulic pump part number (P/N) 109-0760-42-103 being ineligibly
installed on Model AW109SP helicopters. EASA advises that because
hydraulic pump P/N 109-0760-42-103 is not eligible for installation on
Model AW109SP helicopters, applicable instructions for continued
airworthiness are not available. The NPRM proposed to require
accomplishing the actions specified in EASA AD 2019-0213, described
previously, as incorporated by reference, except for any differences
identified as exceptions in the regulatory text of the proposed AD and
except as discussed under ``Differences Between this Proposed AD and
EASA AD 2019-0213.''
    The FAA is issuing this AD to address the ineligible installation
of the affected part-numbered hydraulic pump on Model AW109SP
helicopters since there are no applicable instructions for continuing
airworthiness available. See EASA AD 2019-0213 for additional
background information.

Discussion of Final Airworthiness Directive

Comments

    The FAA received no comments on the NPRM or on the determination of
the costs.

Conclusion

    These helicopters have been approved by EASA and are approved for
operation in the United States. Pursuant to the FAA's bilateral
agreement with the European Union, EASA has notified the FAA about the
unsafe condition described in its AD. The FAA reviewed the relevant
data and determined that air safety requires adopting this AD as
proposed. Accordingly, the FAA is issuing this AD to address the unsafe
condition on these helicopters. Except for minor editorial changes,
this AD is adopted as proposed in the NPRM.

Related Service Information Under 1 CFR Part 51

    EASA AD 2019-0213 requires inspecting each affected hydraulic pump
and depending on the inspection results, replacing an affected
hydraulic pump with a serviceable hydraulic pump, before further
flight. EASA AD 2019-0213 also requires replacing any affected
hydraulic pump before exceeding 1,600 total flight hours (FH) since
first installation on a helicopter, or within 200 FH, whichever occurs
later. Finally, EASA AD 2019-0213 prohibits installing any affected
hydraulic pump on any helicopter.
    This service information is reasonably available because the
interested parties have access to it through their normal course of
business or by the means identified in the ADDRESSES section.

Other Related Service Information

    The FAA also reviewed Leonardo S.p.a. Helicopters, Alert Service
Bulletin No. 109SP-134, dated July 29, 2019. This service information
specifies procedures for inspecting and replacing hydraulic pump P/N
109-0760-42-103.

Differences Between This AD and EASA AD 2019-0213

    EASA AD 2019-0213 applies to Model AW109SP helicopters, all serial
numbers, whereas this AD only applies to Model AW109SP helicopters with
certain part-numbered hydraulic pumps installed.

Costs of Compliance

    The FAA estimates that this AD affects 17 helicopters of U.S.
Registry. Labor rates are estimated at $85 per work-hour. Based on
these numbers, the FAA estimates the following costs to comply with
this AD.
    Visually inspecting each hydraulic pump for wear, burrs, and
abrasion takes about 4 work-hours and parts cost about $5 for an
estimated cost of $345 per inspection and $5,865 for the U.S. fleet.
    Removing from service each affected hydraulic pump and replacing
with an airworthy hydraulic pump takes about 6 work-hours and parts
cost about $22,819 for an estimated cost of $23,329 per pump
replacement.
    The FAA has included all known costs in its cost estimate.
According to the manufacturer, however, some of the costs of this AD
may be covered under warranty, thereby reducing the cost impact on
affected operators.

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.

    The FAA is 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) Will not affect intrastate aviation in Alaska, and
    (3) 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 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:

2021-23-10 Leonardo S.p.a.: Amendment 39-21808; Docket No. FAA-2021-
0720; Project Identifier 2019-SW-079-AD.

(a) Effective Date

    This airworthiness directive (AD) is effective January 10, 2022.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Leonardo S.p.a. Model AW109SP helicopters,
certificated in any category, with an affected part as identified in
European Union Aviation Safety Agency (EASA) AD 2019-0213, dated
August 29, 2019 (EASA AD 2019-0213).

(d) Subject

    Joint Aircraft Service Component (JASC) Codes: 2913, Hydraulic
Pump (Elect/Eng), Main.

(e) Unsafe Condition

    This AD was prompted by reports of the ineligible installation
of hydraulic pump part number (P/N) 109-0760-42-103 on Model AW109SP
helicopters resulting in the applicable instructions for continued
airworthiness not being available. The FAA is issuing this AD to
address this unsafe condition. The unsafe condition, if not
addressed, could result in failure of the hydraulic pump and
subsequent loss of control of the helicopter.

(f) Compliance

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

(g) Requirements

    Except as specified in paragraph (h) of this AD: Comply with all
required actions and compliance times specified in, and in
accordance with, EASA AD 2019-0213.

(h) Exceptions to EASA AD 2019-0213

    (1) Where EASA AD 2019-0213 requires compliance in terms of
flight hours, this AD requires using hours time-in-service (TIS).
    (2) Where EASA AD 2019-0213 requires compliance from its
effective date, this AD requires using the effective date of this
AD.
    (3) Where paragraph (2) of EASA AD 2019-0213 specifies to
replace a part if any discrepancy is detected during the inspection,
this AD requires removing that part from service.
    (4) Where paragraph (3) of EASA AD 2019-0213 specifies to
replace a part before exceeding 1,600 flight hours since first
installation on a helicopter, this AD requires removing that part
from service before 1,600 hours TIS since first installation on a
helicopter.
    (5) Where the service information required by EASA AD 2019-0213
specifies discarding the o-ring and gasket, this AD requires
removing those parts from service.
    (6) Where the service information required by EASA AD 2019-0213
specifies recording compliance with the service bulletin in the
helicopter logbook, this AD does not include that requirement.
    (7) This AD does not require the ``Remarks'' section of EASA AD
2019-0213.

(i) No Reporting Requirement

    Although the service information referenced in EASA AD 2019-0213
specifies to submit certain information to the manufacturer, this AD
does not include that requirement.

(j) Special Flight Permit

    Special flight permits, as described in 14 CFR 21.197 and
21.199, are prohibited.

(k) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, International Validation Branch, 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 International Validation Branch, send
it to the attention of the person identified in paragraph (l) of
this AD. Information may be emailed to: [email protected].
    (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.

(l) Related Information

    For more information about this AD, contact Darren Gassetto,
Aerospace Engineer, COS Program Management Section, Operational
Safety Branch, Compliance & Airworthiness Division, FAA, 1600
Stewart Ave., Suite 410, Westbury, NY 11590; telephone (516) 228-
7323; email [email protected].

(m) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference of the service information listed in this
paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless this AD specifies otherwise.
    (i) European Union Aviation Safety Agency (EASA) AD 2019-0213,
dated August 29, 2019.
    (ii) [Reserved].
    (3) For EASA AD 2019-0213, contact the EASA, Konrad-Adenauer-
Ufer 3, 50668 Cologne, Germany; telephone +49 221 8999 000; email
[email protected]; internet www.easa.europa.eu. You may find this
material on the EASA website at https://ad.easa.europa.eu.
    (4) You may view this service information at the FAA, Office of
the Regional Counsel, Southwest Region, 10101 Hillwood Pkwy., Room
6N-321, Fort Worth, TX 76177. For information on the availability of
this material at the FAA, call<PHONE_NUMBER>. This material may be
found in the AD docket at https://www.regulations.gov by searching
for and locating Docket No. FAA-2021-0720.
    (5) You may view this material that is incorporated by reference
at the National Archives and Records Administration (NARA). For
information on the availability of this material at NARA, email
[email protected], or go to: https://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued on October 28, 2021.
Lance T. Gant,
Director, Compliance & Airworthiness Division, Aircraft Certification
Service.
[FR Doc. 2021-26334 Filed 12-3-21; 8:45 am]
BILLING CODE 4910-13-P