Detection Limits 450a 01 1 Introduction Goal: Examine detection limits, their purpose, definition, and their intended use There are many potential situations in which data censored by detection limits arise One place censored data are generated is through the analysis of survival times This may be applicable to LD50 or LC50 studies that are performed to determine the toxicity of a chemical Our focus is on left censoring of analytical data arising from the use of detection ( or quantitation) limits 450a 01 2 Introduction In the case of survival times, censoring is caused by not being able to observe effect,

or death, after some point in time In the case of " detection limits", censoring is caused by not reporting data below some threshold concentration Note that the underlying distributions are not necessarily truncated, but censoring makes it difficult to estimate parameters 450a 01 3 Introduction Let's consider the following right and left censoring of a joke ( which is our data point):

Right censoring: A statistician's wife had twins. He was delighted. He rang the minister who was also delighted. " Bring them to church on Sunday and we'll baptize them,"

said the minister. " No," he replied. 450a 01 4 Introduction Left censoring: He rang the minister who was also delighted. " Bring them to church on Sunday and we'll baptize them," said the minister. " No," he replied. " Baptize one. We'll keep the other as a control."

Censoring causes some loss of information.

The consequences are lack of complete understanding 450a 01 5 Sensitivity Indicator Numerical Definition Definition Common Use Instrument Detection Limit ( IDL) Usually 3 times the instrument noise level Lowest value at which instrument can distinguish from zero Provides basis for determining an MDL Method Detection Limit ( MDL) MDL = t ( n 1, 0.99) x s s = standard deviation for 7 aliquots:

t ( n 1, 0.99) = 3.14 Defined 40 CFR Part 136 Appendix B Determines the theoretical detection limit Practical Quantitation Limit ( PQL) PQL = 5 x MDL or PQL = 10 x MDL ( more precisely defined as the lowest standard on the instrument calibration curve) " the lowest concentration of an analyte that can be reliably measured within specified limits of precision and accuracy during routine laboratory operating conditions" Provides numerical lower limit for critical data Reporting Limit ( RL) Laboratory defined ( often the RL = PQL) Lowest value reported by laboratory without a " J" flag Laboratory basis for data reporting Types of Detection Limits 450a 01 6 Detection Limits Two types of detection limits are of particular interest and will be presented herein 1. Method Detection Limit ( MDL)

" Imprecision that is added to the detection capabilities of the instrument due to the sample processing manipulations and the sample matrix"  US EPA NRMRL 450a 01 7 Detection Limits 2. Practical Quantitation Limit ( PQL)

" Concentration of the lowest calibration standard ( by default). The low calibration standard is usually determined by accounting for the sample matrix, dilutions needed, sample volumes/ weight used, and final volumes used. It is usually some multiple of the MDL"  EPA QA/ G 5i 450a 01 8 Detection Limits Why detection limits?

Because of a desire to avoid erroneously reporting the presence of an analyte ( i. e., to control false positives)

Because of measurement variability This raises the question of when does a positive response represent a detected analyte? 450a 01 9 Chemical Measurement In general, the measurement process is very complex, involves many details ( e. g., drift,

fluctuation, baseline, calibration), and varies from method to method Calculation of detection limits have largely been standardized, perhaps to accommodate the many intricacies of the measurement system 450a 01 10 Method Detection Limit The MDL has a regulatory definition in 40CFR136 Appendix B:

" The minimum concentration of a substance ( analyte) that can be measured and reported with 99% confidence that the analyte concentration is greater than zero, and is determined from analysis of a sample in a given matrix type containing the analyte." 450a 01 11 Method Detection Limit An MDL is interpreted in terms of a distribution of blanks That is, we determine the " upper 99%

confidence limit/ bound" on a blank distribution We use the MDL as the threshold concentration that determines detect status for future individual samples 450a 01 12 Method Detection Limit The problems

The MDL is not usually established by measuring blanks, but by measuring standards at very low concentration, and then extrapolating through assumption to the blank distribution Lack of universal understanding of " confidence" 450a 01 13 Method Detection Limit Does it make any difference that we use low concentration standards instead of blanks?

Perhaps not if the standard deviation is the same in both cases This is a fundamental assumption of this approach the standard deviation is the same within a range of low concentrations 450a 01 14 0.1 0.2 0.3 0.4 Distribution of the blank from MDL study   Assumption of Equivalent Variances.

0 It is assumed the shape is the same despite a location shift 450a 01 15 Method Detection Limit 1. A known standard is selected at a concentration that is expected to be close to the MDL 2. Replicates from this standard are analyzed 3. A ( preliminary) MDL is determined from these data 4. If the preliminary MDL and standard are " close enough", then use the preliminary MDL, otherwise repeat the experiment using a lower standard 450a 01 16 Method Detection Limit The MDL defined by 40CFR136 Appendix B:

MDL = t( n  1, 1    ) x s where, s = the estimated standard deviation associated with the sample The expression, t( n  1, 1   ), represents a specific value from the t distribution associated with n samples ( or n  1 degrees of freedom) 450a 01 17 Method Detection Limit  , the false positive rate, is set at 1%

( corresponding to a 99% value from the t distribution)

Hence, t( n  1, 1   ), is the 99th percentile of the standard t distribution with n 1 degrees of freedom Hence, the MDL ( t x s) is the estimated 99 th percentile of the blank distribution 450a 01 18 MDL Example Suppose an MDL study was performed where 7 samples were used to establish a MDL Suppose the standard was 1 ppm, and we are given the following data:

The estimated standard deviation is s = 0.264 0.7 0.8 0.9 1.0 1.1 1.2 1.4 450a 01 19  4  2 0 2 4 0.1 0.2 0.3 0.4 3.14 0.99 0.01 t distribution with ( 7 1)= 6 Degrees of Freedom 450a 01 20 MDL Example The t statistic, 3.14 ( tabled value from the t distribution) is then multiplied by the sample standard deviation, 0.264, to obtain the MDL MDL = t( 6,0.99) x s = 3.14 x 0.264 = 0.83 In this example, 0.83 ( the MDL) is probably close enough to 1 ppm ( the standard), that further iteration is not required 450a 01 21 MDL Example Interpretive problem

There is no statistical concept of confidence in any part of the analysis What we have actually estimated is a percentile of a distribution There isn't anything wrong with that, but it has nothing to do with statistical confidence intervals 450a 01 22 MDL Example Suppose we get a reported concentration of 0.7 ppm for a specific analyte Do we believe that the analyte is present?

What is the chance that the analyte is present?

How does the relationship between the reported concentration and the MDL affect the chance the analyte is present? 450a 01 23 MDL Example This can be interpreted as a 98% probability that the analyte reported at 0.7 is actually present Even a reported value of 0.2 has a probability that the analyte is present of about 0.75 However, one should realize that a reported value of 0, using this model, has a probability that the analyte is present of 0.5 450a 01 24  1.0  0.5 0.0 0.5 1.0 0.0 0.5 1.0 1.5 0.7 Probability of Observing 0.7 ppm ( or Greater)

0.02 0.02 450a 01 25  1.0  0.5 0.0 0.5 1.0 0.0 0.5 1.0 1.5 0.7 Probability of Observing Small Concentrations 0.02 0.2 0.50 0.25 450a 01 26 Practical Quantitation Limit There are many types of quantitation limits,

the intention of all of them is to provide some more " confidence" in reported concentrations Practical quantitation limits are defined as " the lowest concentration of an analyte that can be reliably measured within specified limits of precision and accuracy during routine laboratory operating conditions"

 US EPA QA/ G 5i 450a 01 27 Practical Quantitation Limit Some are defined as a multiple of the MDL between 2 and 5 are common Some are defined as a number of standard deviations from zero around 10 standard deviations is common 450a 01 28 Relationship of Detection Limits 3  10   Zero Analyte Concentration Region of high uncertainty Region of more certain detection Region of less certain quantification Approximate MDL Level Region of more certain quantification Instrument signal, standard deviation units Matrix/ method blank Approximate PQL Level   = population standard deviation 0 450a 01 29 Practical Quantitation Limit Given the MDL discussion, it would appear that PQLs are a very conservative censoring mechanism. Why are they used?

The purpose relates to the desire to define a linear range ( a calibration range) that is sufficiently far from noise levels, but still likely to serve the purposes of the study, and to which all analyses are targeted That is, the PQL defines the lower end of the concentration range for which reported concentrations are not flagged 450a 01 30 MDL/ PQL Example Let's revisit the study where 7 samples were used to establish a MDL The estimated standard deviation was s = 0.264 Recall that the MDL was calculated to be 0.83 ppm The PQL was set at 10  = 2.64 ppm 0.7 0.8 0.9 1.0 1.1 1.2 1.4 450a 01 31 Data Reporting Data within the calibration range are reported without flags If high concentration samples are not diluted and re analyzed, then they are flagged as estimated ( J)

Values below the PQL are flagged as estimated ( J)

Values less than the MDL are flagged as not detected ( U) 450a 01 32 MDL/ PQL Example In our example

Data reported below 0.83 ppm is flagged with a " U" to indicate that the analyte was not detected Data reported above 0.83 ppm, but below 2.64 ppm, is flagged with a " J" to indicate that the value is estimated Data reported above 2.64 ppm is not flagged 450a 01 33 Conclusions From a statistician's perspective, censoring both results in a loss of information and causes difficulties in statistical analysis The decision focus is on data From a chemist's perspective, censoring more realistically reflects their knowledge about the analytical process Their focus is on each datum If all the information is provided and couched appropriately, then it is possible to accommodate both concerns 450a 01 34 Conclusions How detection limits are used and their impact on analysis depends not only on the objectives of the study, but also on the magnitude of the concentrations of interest For many analytes detection limits are not of concern because the reporting values are well above this limit Detection limits are also not a concern when the threshold concentrations of interest are much greater than this limit 450a 01 35 For other analytes, the detection limits are similar to reporting values, so they are a concern Detection limits are a concern when they are close to the threshold concentrations of interest Many methods are available for handling detection limits in data analyses Conclusions 450a 01 36


[Federal Register Volume 86, Number 154 (Friday, August 13, 2021)]
[Proposed Rules]
[Pages 44652-44655]
[FR Doc No: 2021-17032]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2021-0653; Project Identifier AD-2021-00170-R]
RIN 2120-AA64

Airworthiness Directives; MD Helicopters Inc. (MDHI) Helicopters

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: The FAA proposes to adopt a new airworthiness directive (AD)
for MD Helicopters Inc. (MDHI), Model 369D, 369E, 369F, 369FF, 369H,
369HE, 369HM, 369HS, 500N, and 600N helicopters. This proposed AD was
prompted by a report of a spiral crack in the pilot-to-copilot tail
rotor torque tube (torque tube). This proposed AD would require a one-
time visual and recurring borescope inspections of the torque tube and
depending on the results, removing the torque tube from service. The
FAA is proposing this AD to address the unsafe condition on these
products.

DATES: The FAA must receive comments on this proposed AD by September
27, 2021.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to https://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590.
     Hand Delivery: Deliver to Mail address between 9 a.m. and
5 p.m.,

Monday through Friday, except Federal holidays.
    For service information identified in this NPRM, contact MD
Helicopters, Inc., Attn: Customer Support Division, 4555 E McDowell
Rd., Mail Stop M615, Mesa, AZ 85215-9734; telephone<PHONE_NUMBER>; fax
(480) 346-6813; or at https://www.mdhelicopters.com. 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>.

Examining the AD Docket

    You may examine the AD docket at https://www.regulations.gov by
searching for and locating Docket No. FAA-2021-0653; 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 NPRM, any comments
received, and other information. The street address for Docket
Operations is listed above.

FOR FURTHER INFORMATION CONTACT: Payman Soltani, Aerospace Engineer,
Airframe Section, Los Angeles ACO Branch, Compliance & Airworthiness
Division, FAA, 3960 Paramount Blvd., Lakewood, CA 90712; telephone
(562) 627-5313; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comments Invited

    The FAA invites you to send any written relevant data, views, or
arguments about this proposal. Send your comments to an address listed
under ADDRESSES. Include ``Docket No. FAA-2021-0653; Project Identifier
AD-2021-00170-R'' at the beginning of your comments. The most helpful
comments reference a specific portion of the proposal, explain the
reason for any recommended change, and include supporting data. The FAA
will consider all comments received by the closing date and may amend
this proposal because of those comments.
    Except for Confidential Business Information (CBI) as described in
the following paragraph, and other information as described in 14 CFR
11.35, the FAA will post all comments received, without change, to
https://www.regulations.gov, including any personal information you
provide. The agency will also post a report summarizing each
substantive verbal contact received about this NPRM.

Confidential Business Information

    CBI is commercial or financial information that is both customarily
and actually treated as private by its owner. Under the Freedom of
Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public
disclosure. If your comments responsive to this NPRM contain commercial
or financial information that is customarily treated as private, that
you actually treat as private, and that is relevant or responsive to
this NPRM, it is important that you clearly designate the submitted
comments as CBI. Please mark each page of your submission containing
CBI as ``PROPIN.'' The FAA will treat such marked submissions as
confidential under the FOIA, and they will not be placed in the public
docket of this NPRM. Submissions containing CBI should be sent to
Payman Soltani, Aerospace Engineer, Airframe Section, Los Angeles ACO
Branch, Compliance & Airworthiness Division, FAA, 3960 Paramount Blvd.,
Lakewood, CA 90712; telephone<PHONE_NUMBER>; email
<EMAIL_ADDRESS>Any commentary that the FAA receives which is
not specifically designated as CBI will be placed in the public docket
for this rulemaking.

Background

    The FAA proposes to adopt a new AD for MDHI Model 369D, 369E, 369F,
369FF, 369H, 369HE, 369HM, 369HS, 500N, and 600N helicopters. This
proposed AD would require a one-time visual and recurring borescope
inspections of the torque tube and depending on the results, removing
the torque tube from service. This proposed AD was prompted by a report
of a spiral crack in the torque tube that appears to have originated
from a hole where the tail rotor torque tube control fitting attaches
to the torque tube on a Model 369FF helicopter. This crack resulted in
increased left pedal movement and subsequent reduced directional
control pedal authority. Other model helicopters are affected due to
design similarity. This condition, if not addressed, could result in
failure of the torque tube, loss of tail rotor control, and subsequent
loss of control of the helicopter.

FAA's Determination

    The FAA is issuing this NPRM after determining that the unsafe
condition described previously is likely to exist or develop on other
products of these same type designs.

Related Service Information Under 1 CFR Part 51

    The FAA reviewed MD Helicopters Service Bulletin SB369D-229R2 for
Model 369D helicopters, SB369E-129R2 for Model 369E helicopters,
SB369F-119R2 for Model 369F and 369FF helicopters, SB369H-263R2 for
Model 369H, 369HE, 369HM, and 369HS helicopters, SB500N-066R2 for Model
500N helicopters, and SB600N-080R2 for Model 600N helicopters, each
dated March 24, 2021 (Revision 2). These service bulletins are co-
published as one document. Revision 2 of this service information
specifies procedures for a one-time visual inspection and recurring
borescope inspections, completing a Service Operation Report, and
returning a removed torque tube to an authorized service center or
MDHI.

Other Related Service Information

    The FAA also reviewed MD Helicopters Service Bulletin SB369H-263,
SB369D-229, SB369E-129, SB369F-119, SB500N-066, and SB600N-080, each
dated January 30, 2020 (initial issuance), and MD Helicopters Service
Bulletin SB369H-263R1, SB369D-229R1, SB369E-129R1, SB369F-119R1,
SB500N-066R1, and SB600N-080R1, each dated May, 15 2020 (Revision 1).
The initial issuance and Revision 1 of this service information specify
the same procedures as Revision 2 of this service information, except
Revision 1 clarified the torque value to apply to the nut and Revision
2 deletes Method 2 of the Accomplishment Instructions and adds a
recurring 300-hour borescope inspection of the torque tube.

Proposed AD Requirements in This NPRM

    This proposed AD would initially require visually inspecting the
torque tube exterior using a flashlight and mirror and borescope
inspecting the interface of the torque tube and bushing segments for a
crack, elongation, and other damage, which may be indicated by any
corrosion, pitting, crazing, dents, dings, displacement of material at
the bolt hole edge, or fretting of the hole. Thereafter, this proposed
AD would require repeating the borescope inspection. If there is a
crack, elongation, or other damage, this proposed AD would require
removing the torque tube from service.

Differences Between This Proposed AD and the Service Information

    For helicopters that have accumulated 600 or less total hours time-
in-service (TIS), Revision 2 of the service information specifies an
initial compliance time of during the next 100-hour inspection, whereas
this proposed AD would require initial actions within 100 hours TIS
after the effective date of this AD instead. For helicopters that have
accumulated more than 600 total

hours TIS, Revision 2 of the service information specifies initial a
compliance time of within 5 hours of flight time, whereas this proposed
AD would require initial actions within 5 hours TIS or 30 days after
the effective date of this AD, whichever occurs later, instead.
    Revision 2 of the service information specifies returning a removed
torque tube, whereas this proposed AD would require removing the torque
tube from service instead. Revision 2 of the service information
specifies completing a Service Operation Report, whereas this proposed
AD does not include that requirement.

Costs of Compliance

    The FAA estimates that this AD, if adopted as proposed, would
affect 58 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 proposed AD.
    Visually inspecting the torque tube would take a minimal amount of
time. Borescope inspecting the torque tube would take about 1 work-hour
for an estimated cost of $85 per helicopter and $4,930 for the U.S.
fleet, per inspection cycle.
    If required, replacing the torque tube would take about 5 work-
hours and parts would cost about $983 for an estimated cost of $1,408
per helicopter.
    The FAA has included all known costs in its cost estimate.
According to the manufacturer, however, some of the costs of this
proposed 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

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

List of Subjects in 14 CFR Part 39

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

The Proposed Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

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

MD Helicopters Inc. (MDHI): Docket No. FAA-2021-0653; Project
Identifier AD-2021-00170-R.

(a) Comments Due Date

    The FAA must receive comments on this airworthiness directive
(AD) by September 27, 2021.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to MD Helicopters Inc. (MDHI) Model 369D, 369E,
369F, 369FF, 369H, 369HE, 369HM, 369HS, 500N, and 600N helicopters,
certificated in any category, with pilot-to-copilot tail rotor
torque tube (torque tube) part number 369H7531-9/-11/-13, installed.

(d) Subject

    Joint Aircraft Service Component (JASC) Code: 6720, Tail Rotor
Control System.

(e) Unsafe Condition

    This AD was prompted by a report of a spiral crack in the torque
tube. The FAA is issuing this AD to prevent failure of a torque
tube. The unsafe condition, if not addressed, could result in loss
of tail rotor control and subsequent loss of control of the
helicopter.

(f) Compliance

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

(g) Required Actions

    (1) Using a flashlight and mirror, visually inspect the exterior
of the torque tube at the interface of the torque tube and bushing
segments, and borescope inspect the interior of the torque tube at
the interface of the torque tube and bushing segments for a crack,
elongation, and other damage, which may be indicated by any
corrosion, pitting, crazing, dents, dings, displacement of material
at the bolt hole edge, or fretting of the hole by following the
Accomplishment Instructions, paragraphs 2.A.(1). through (3).(a).,
of MD Helicopters Service Bulletin SB369H-263R2, SB369D-229R2,
SB369E-129R2, SB369F-119R2, SB500N-066R2, or SB600N-080R2, each
dated March 24, 2021, as applicable to your model helicopter, as
follows:
    Note 1 to paragraph (g)(1): Scaling of the inner diameter primer
or paint may be an indication of a crack.
    (i) For helicopters that have accumulated 600 or less total
hours time-in-service (TIS), within 100 hours TIS after the
effective date of this AD.
    (ii) For helicopters that have accumulated more than 600 total
hours TIS, within 5 hours TIS or 30 days after the effective date of
this AD, whichever occurs later.
    Note 2 to paragraph (g)(1)(ii): It is advised to limit flights
with increased, excessive, or rapid pedal movements before the first
instance of the actions required by paragraph (g)(1)(ii) are
accomplished.
    (iii) If there is a crack, elongation, or other damage, before
further flight, remove the torque tube from service.
    (2) Thereafter following paragraph (g)(1) of this AD, at
intervals not to exceed 300 hours TIS, borescope inspect the
interior of the torque tube at the interface of the torque tube and
bushing segments as required by paragraph (g)(1) of this AD. If
there is a crack, elongation, or other damage, before further
flight, remove the torque tube from service.

(h) Credit for Previous Actions

    You may take credit for the instance of the actions required by
paragraphs (g)(1)(i) or (ii) of this AD if you performed
corresponding actions before the effective date of this AD using MD
Helicopters Service Bulletin SB369H-263, SB369D-229, SB369E-129,
SB369F-119, SB500N-066, or SB600N-080, each dated January 30, 2020,
as applicable to your model helicopter, or MD Helicopters Service
Bulletin SB369H-263R1, SB369D-229R1, SB369E-129R1, SB369F-119R1,
SB500N-066R1, or SB600N-080R1, each dated May, 15 2020, as
applicable to your model helicopter.

(i) No Reporting Requirement

    Although MD Helicopters Service Bulletin SB369H-263R2, SB369D-
229R2, SB369E-129R2, SB369F-119R2, SB500N-066R2, and SB600N-080R2,
each dated March 24, 2021, specify to submit certain information to
the manufacturer, this AD does not include that requirement.

(j) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Los Angeles ACO, FAA, has the authority to
approve AMOCs for this AD, if requested using the procedures found
in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request
to your principal inspector or local Flight Standards District
Office, as appropriate. If sending information directly to the
manager of the certification office, information may be emailed to:
<EMAIL_ADDRESS>    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.

(k) Related Information

    (1) For more information about this AD, contact Payman Soltani,
Aerospace Engineer, Airframe Section, Los Angeles ACO Branch,
Compliance & Airworthiness Division, FAA, 3960 Paramount Blvd.,
Lakewood, CA 90712; telephone<PHONE_NUMBER>; email
<EMAIL_ADDRESS>    (2) For service information identified in this AD, contact MD
Helicopters, Inc., Attn: Customer Support Division, 4555 E McDowell
Rd., Mail Stop M615, Mesa, AZ 85215-9734; telephone<PHONE_NUMBER>;
fax<PHONE_NUMBER>; or at https://www.mdhelicopters.com. You may
view this referenced 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>.

    Issued on August 2, 2021.
Lance T. Gant,
Director, Compliance & Airworthiness Division, Aircraft Certification
Service.
[FR Doc. 2021-17032 Filed 8-12-21; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 81, Number 138 (Tuesday, July 19, 2016)]
[Notices]
[Pages 46998-46999]
[FR Doc No: 2016-16935]

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

DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[Docket No. NHTSA-2016-0060; Notice 1]

Notice of Receipt of Petition for Decision That Nonconforming
Model Year 2011 Ducati Multistrada Motorcycles Are Eligible for
Importation

AGENCY: National Highway Traffic Safety Administration, DOT.

ACTION: Receipt of petition.

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

SUMMARY: This document announces receipt by the National Highway
Traffic Safety Administration (NHTSA) of a petition for a decision that
model year (MY) 2011 Ducati Multistrada Motorcycles (MCs) that were not
originally manufactured to comply with all applicable Federal motor
vehicle safety standards (FMVSS), are eligible for importation into the
United States because they are substantially similar to vehicles that
were originally manufactured for sale in the United States and that
were certified by their manufacturer as complying with the safety
standards (the U.S.-certified version of the 2011 Ducati Multistrada
Motorcycles) and they are capable of being readily altered to conform
to the standards.

DATES: The closing date for comments on the petition is August 18,
2016.

ADDRESSES: Comments should refer to the docket and notice numbers above
and be submitted by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the online instructions for submitting
comments.
     Mail: Docket Management Facility: U.S. Department of
Transportation, 1200 New Jersey Avenue SE., West Building Ground Floor,
Room W12-140, Washington, DC 20590-0001
     Hand Delivery or Courier: West Building Ground Floor, Room
W12-140, 1200 New Jersey Avenue SE., between 9 a.m. and 5 p.m. ET,
Monday through Friday, except Federal holidays.
     Fax:<PHONE_NUMBER>
    Instructions: Comments must be written in the English language, and
be no greater than 15 pages in length, although there is no limit to
the length of necessary attachments to the comments. If comments are
submitted in hard copy form, please ensure that two copies are
provided. If you wish to receive confirmation that your comments were
received, please enclose a stamped, self-addressed postcard with the
comments. Note that all comments received will be posted without change
to http://www.regulations.gov, including any personal information
provided. Please see the Privacy Act heading below.
    Privacy Act: Anyone is able to search the electronic form of all
comments received into any of our dockets by the name of the individual
submitting the comment (or signing the comment, if submitted on behalf
of an association, business, labor union, etc.). You may review DOT's
complete Privacy Act Statement in the Federal Register published on
April 11, 2000 (65 FR 19477-78).
    How to Read Comments submitted to the Docket: You may read the
comments received by Docket Management at the address and times given
above. You may also view the documents from the Internet at http://www.regulations.gov. Follow the online instructions for accessing the
dockets. The docket ID number and title of this notice are shown at the
heading of this document notice. Please note that even after the
comment closing date, we will continue to file relevant information in
the Docket as it becomes available. Further, some people may submit
late comments. Accordingly, we recommend that you periodically search
the Docket for new material.

FOR FURTHER INFORMATION CONTACT: George Stevens, Office of Vehicle
Safety Compliance, NHTSA<PHONE_NUMBER>).

SUPPLEMENTARY INFORMATION:

Background

    Under 49 U.S.C. 30141(a)(1)(A), a motor vehicle that was not
originally manufactured to conform to all applicable FMVSS shall be
refused admission into the United States unless NHTSA has decided that
the motor vehicle is substantially similar to a motor vehicle
originally manufactured for importation into and sale in the United
States, certified under 49 U.S.C. 30115, and of the same model year as
the model of the motor vehicle to be compared, and is capable of being
readily altered to conform to all applicable FMVSS.
    Petitions for eligibility decisions may be submitted by either
manufacturers or importers who have registered with NHTSA pursuant to
49 CFR part 592. As specified in 49 CFR 593.7, NHTSA publishes notice
in the Federal Register of each petition that it receives, and affords
interested persons an opportunity to comment on the petition. At the
close of the comment period, NHTSA decides, on the basis of the
petition and any comments that it has

received, whether the vehicle is eligible for importation. The agency
then publishes this decision in the Federal Register.
    Skytop Rover Co. (Skytop), of Philadelphia, Pennsylvania
(Registered Importer R-06-343) has petitioned NHTSA to decide whether
nonconforming 2011 Ducati Multistrada MCs are eligible for importation
into the United States. The vehicles which Skytop believes are
substantially similar are MY 2011 Ducati Multistrada MCs sold in the
United States and certified by their manufacturer as conforming to all
applicable FMVSS.
    The petitioner claims that it compared non-U.S. certified MY 2011
Ducati Multistrada MCs to their U.S.-certified counterparts, and found
the vehicles to be substantially similar with respect to compliance
with most FMVSS.
    Skytop submitted information with its petition intended to
demonstrate that non-U.S. certified MY 2011 Ducati Multistrada MCs, as
originally manufactured, conform to many applicable FMVSS in the same
manner as their U.S.-certified counterparts, or are capable of being
readily altered to conform to those standards. Specifically, the
petitioner claims that the non U.S.-certified MY 2011 Ducati
Multistrada MCs, as originally manufactured, conform to: Standard Nos.
106 Brake Hoses, 111 Rear Visibility, 116 Motor Vehicle Brake Fluids,
and 122 Motorcycle Brake Systems.
    The petitioner also contends that the subject non-U.S certified
vehicles are capable of being readily altered to meet the following
standards, in the manner indicated:
    Standard No. 108 Lamps, Reflective Devices and Associated
Equipment: Inspection of each vehicle and replacement of non-conforming
components with U.S.-model components on any vehicle not already so
equipped.
    Standard No. 120 Tire Selection And Rims And Motor Home/Recreation
Vehicle Trailer Load Carrying Capacity Information for Motor Vehicles
With a GVWR of More Than 4,536 Kilograms (10,000 Pounds): Installation
of the required tire information placard.
    Standard No. 123 Motorcycle Controls and Displays: Inspection of
each vehicle and replacement of non-conforming speedometers with U.S.-
model components on vehicles not already so equipped.
    Standard No. 205 Glazing Materials: Inspection of each vehicle and
removal of noncompliant glazing or replacement with U.S. certified
glazing.
    All comments received before the close of business on the closing
date indicated above will be considered, and will be available for
examination in the docket at the above addresses both before and after
that date. To the extent possible, comments filed after the closing
date will also be considered. Notice of final action on the petition
will be published in the Federal Register pursuant to the authority
indicated below.

    Authority:  49 U.S.C. 30141(a)(1)(A), (a)(1)(B), and (b)(1); 49
CFR 593.7; delegation of authority at 49 CFR 1.95 and 501.8.

Jeffrey M. Giuseppe,
Director, Office of Vehicle Safety Compliance.
[FR Doc. 2016-16935 Filed 7-18-16; 8:45 am]
 BILLING CODE 4910-59-P