[Federal Register Volume 78, Number 112 (Tuesday, June 11, 2013)]
[Notices]
[Pages 35094-35098]
[FR Doc No: 2013-13779]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

Denial of Motor Vehicle Defect Petition, DP12-001

AGENCY: National Highway Traffic Safety Administration (NHTSA), DOT.

ACTION: Denial of petition for a defect investigation.

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SUMMARY: This notice describes the reasons for denying a petition
(DP12-001) submitted to NHTSA under 49 U.S.C. Subtitle B, Chapter V,
Part 552, Subpart A, requesting that the agency ``open an
investigation'' into ``the repeated final drive bearing failure and
possibly flawed assembly controls of the final drive unit on BMW
K1200LT [motorcycles].''

FOR FURTHER INFORMATION CONTACT: Bob Young, Office of Defects
Investigation (ODI), NHTSA; 1200 New Jersey Ave. SE; Washington, DC
20590. Telephone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: By letter dated November 28, 2011, Mr.
Christopher D. Cimino wrote to NHTSA requesting that the agency open an
investigation into ``the repeated final drive bearing failure and
possibly flawed assembly controls of the final drive unit on BMW
K1200LT [motorcycles]'' and to require BMW to ``recall the affected
models for inspection of component wear and proper assembly of the
[final drive].''
    NHTSA reviewed the material provided by the petitioner and other
pertinent data that the agency gathered since first learning of this
issue in February, 2003. The results of this review and NHTSA's
analysis of the petition's merit is set forth in the DP12-001 Petition
Analysis Report, published in its entirety as an appendix to this
notice.
    For the reasons presented in the petition analysis report, it is
unlikely that an order concerning the notification and remedy of a
safety-related defect would be issued as a result of granting Mr.
Cimino's request. Therefore, in view of the need to allocate and
prioritize NHTSA's limited resources to best accomplish the agency's
safety mission, the petition is denied.

    Authority: 49 U.S.C. 30162(d); delegations of authority at CFR
1.50 and 501.8.

    Issued on: June 5, 2013.
Nancy Lummen Lewis,
Associate Administrator for Enforcement.

Appendix

Petition Analysis--DP12-001

1.0 Introduction

    On December 5, 2011 the National Highway Traffic Safety
Administration (NHTSA) received a letter (dated November 28, 2011)
from Mr. Christopher D. Cimino, requesting NHTSA to investigate
repeated final drive bearing failure[s] on certain BMW K1200LT model
motorcycles and require BMW to recall the affected models for
inspection of component wear and proper assembly of the unit. In
support of his request, Mr. Cimino cites: an earlier BMW motorcycle
recall addressing a final drive oil loss issue (06V399); \1\ related
consumer complaints filed with NHTSA; \2\ an internet-based registry
of owners experiencing a final drive ``failure''; \3\ an article
appearing in a motorcycle related magazine; \4\ and his own personal
experience wherein he had to replace the final drive ring gear ball-
type bearing twice. Mr. Cimino also included the damaged bearing
parts from his most recent incident. While Mr. Cimino did not style
his letter as a petition in accordance with 49 U.S.C. Part 552.4,
NHTSA is treating it as such.
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    \1\ NHTSA Recall 06V399 was filed on 10-9-06. This recall
addresses oil leaking from the speed sensor o-ring of approximately
700 BMW motorcycles.
    \2\ Mr. Cimino cites 145 consumer complaints which he found at
http://www-odi.nhtsa.dot.gov/complaints/.
    \3\ Now defunct, a internet-based registry of related final-
drive complaints could be found at www.bmwfinaldrive.com.
    \4\ Bill Shaw, ``Tarnished Roundel--Final Drive Failures Taint
BMW's Image,'' Motorcycle Consumer News, Sep. 2008.
---------------------------------------------------------------------------

    In analyzing the petitioner's allegations and preparing a
response, NHTSA:
     Reviewed and analyzed the petitioner's November 28th
letter and attachments;
     Discussed Mr. Cimino's allegations with him;
     Reviewed NHTSA consumer complaints identified by Mr.
Cimino and those submitted to the agency after he filed his request;
     Reviewed Early Warning Reporting (EWR) data submitted
by BMW pursuant to C.F.R. Sec.  579.23;
     Reviewed information related to BMW's safety recall
(06V399);
     Conducted a comprehensive internet-based search for
information concerning sudden, unforeseen subject final drive
bearing failure resulting in loss of motorcycle control;
     Reviewed NHTSA's consumer complaint database for
relevant reports;
     Reviewed www.bmwlt.com, www.ibmwr.org, www.bmwmoa.org,
and www.bmwra.org for relevant Internet forum postings;
     Analyzed data related to the internet-based registry of
final drive-related complaints found at www.bmwfinaldrive.com;
     Conducted informal interviews with K1200LT owners at
various BMW Motorcycle Owners of America (BMWMOA) and BMW Riders
Association (BMWRA) national rallies;
     Participated in discussions with technical experts at
the BMWMOA and BMWRA national rallies;
     Participated in discussions with BMW Motorrad (BMW's
motorcycle division) dealer service personnel;
     Reviewed magazine articles pertaining to the final
drive bearing issue, and conducted informal discussions with the
authors of those articles;
     Conducted a comprehensive, internet-based search for
information (including forum postings) concerning sudden, unforeseen
subject final drive bearing failure resulting in loss of motorcycle
control.
    The information gathered and reviewed during this comprehensive
effort fails to establish that a safety-related defect trend
involving a final drive bearing failure exists in the subject
motorcycles. Consequently, the petition is denied.

2.0 The Petioner's Allegations

    The petitioner wrote to NHTSA on November 28, 2011 requesting
that the agency open an investigation into ``the repeated final
drive bearing failure and possibly flawed assembly controls of the
final drive unit on BMW K1200LT [motorcycles].'' Prior to sending
this letter, the petitioner experienced two crown gear bearing
failures involving his model year (MY) 2001 K1200LT motorcycle. The
first failure occurred in December, 2008 when the motorcycle had
been driven 59,310 miles; the

second failure occurred on October 21, 2011 at 75,994 miles. Neither
incident resulted in a loss of control. The petitioner, an
experienced motorcyclist, free-lance journalist, and Motorcycle
Safety Foundation ``Rider Coach,'' alleged that the defect exposes
subject vehicle operators to ``potential loss of control, possible
crash, injury and . . . eventual fatality.'' Regarding his own
experience, the petitioner stated that when the final drive bearing
failed, the bearing parts could have caused the rear wheel to lock
at speed, likely resulting in a loss of control. Further, the final
drive oil leaking from the damaged bearing seal onto to rear tire
could have resulted in a loss of traction for the rear wheel.

3.0 Subject Motorcycles

    This analysis covers all MY 1998 through 2010 BMW K1200LT
motorcycles (shown in Image (1) produced for sale in the United
States. Weighing 866 lbs., this ``Luxury Tourer'' motorcycle is a
direct competitor of the Honda ``Goldwing'' and was the heaviest
motorcycle in BMW's lineup during those model years. As a ``full-
dress'' touring motorcycle, it was also equipped with large capacity
panniers and an integrated tail trunk giving it a ``payload''
weight-carrying capability of 456 lbs. (including driver and
passenger) for a gross vehicle weight rating of 1,322 lbs. All
subject motorcycles are equipped with BMW's ``Paralever'' rear
suspension/shaft drive system.
[GRAPHIC] [TIFF OMITTED] TN11JN13.000

4.0 Subject ``Final Drive''

    In 1988, BMW Motorrad introduced the ``Paralever'' rear
suspension/shaft drive swingarm (an upgrade from the company's
original ``Monolever'' single-sided swingarm first seen on the MY
1980 R80GS). All of the subject motorcycles are manufactured with a
``Paralever'' suspension/shaft drive (shown in Image 2). The ``final
drive'' is this Paralever element:
[GRAPHIC] [TIFF OMITTED] TN11JN13.001

    Internally, the final drive is comprised of the components
identified in Image 3. Owners report incidents of ``ball bearing''
(i.e., ``crown gear bearing'') and this analysis focuses on that
allegation.

[GRAPHIC] [TIFF OMITTED] TN11JN13.002

5.0 Consumer Complaints

    In analyzing this petition's merit, NHTSA gathered information
about allegations of final drive bearing failures. In particular,
NHTSA looked for indications that the failure(s) were sudden,
unforeseen, and resulted in the driver's inability to control the
motorcycle.

5.1 ``BMW FinalDrive.com'' Database

    As owner concern about BMW final drive issues increased, an
internet-based forum survey was conducted by a BMW motorcycle owner.
By late 2009, at the survey's conclusion, 156 final drive bearing
failure reports were logged with 70 involving the subject
motorcycles. No verified crashes or loss of control allegations were
noted.
    Bearings give different warnings when they are failing including
noise, increased vibrations, and the visible loss of bearing
material. The alleged final drive bearing failures listed in the BMW
FinalDrive.com database are consistent with these universally
accepted bearing failure characteristics. Under ``Precursor,'' those
filing complaint(s) reported they became aware of impending bearing
failure in the following ways:
     Vibration/Noise--64 reports
     Oil leak--27 reports
     Unknown--26 reports
     Ride Quality--16 reports
     Drain plug (debris noted on the magnet)--14 reports
     Static rear wheel looseness--8 reports
     No Warning--1 report

5.2 Internet Forums

    Numerous Internet forums concerning the alleged final drive
bearing failures exist. Because the same person often posts about
one event on multiple forums, obtaining an accurate count or
verifying incidents is not practical. Nevertheless, NHTSA conducted
a review of the forums and still failed to find any allegations of
crown gear bearing failure that resulted in a loss of motorcycle
control.

5.3 BMW Motorcycle Owners of America and BMW Riders Association Rallies

    Since 2003, when NHTSA became aware of final drive failures on
the subject motorcycles, the agency has attended 10 national rallies
catering exclusively to BMW motorcycle owners. Both the BMW
Motorcycle Owners of America (MOA) and the BMW Riders Association
(RA) hold annual rallies drawing thousands of BMW motorcycle riders
including hundreds of BMW K1200LT riders. During the rallies
attended by NHTSA, the staff informally interviewed BMW motorcycle
owners (including those with K1200LTs) about any final drive issues
they might have experienced. While many owners expressed concern
about the perceived safety consequence of a final drive failure,
those who actually experienced a crown gear bearing failure reported
that they retained complete control of the motorcycle when the
incident occurred.
    Additionally, while attending the rallies, NHTSA staff conducted
seminars about the agency's safety defect program. During the
question-and-answer portion of the seminars, NHTSA staff were asked
about the agency's activities related to the BMW K1200LT final drive
failure. As motorcyclists discussed their experience with a final
drive bearing failure, NHTSA heard from many owners that a pre-ride
check (as recommended by the Motorcycle Safety Foundation in its
Basic Rider Course) would reveal if a bearing failure was imminent.
If either rear wheel looseness and/or oil weeping from the ball
bearing seal are noted, the bearing should be replaced before total
failure occurs. Those who had experienced a final drive failure
maintained that a loss of control could occur, but without
exception, a loss of control was not reported.

5.4 BMW's Early Warning Reporting (EWR) Data

    Since 2003, vehicle manufacturers have been required to provide
EWR data to NHTSA on a quarterly basis. This data includes reports
of incidents involving death(s) or injury(ies) and field reports. A
comprehensive search of the BMW EWR data failed to identify any
reports involving a K1200LT final drive failure.

5.4 NHTSA's Consumer Complaint Database

    As of October 31, 2012, consumers have filed 122 reports with
NHTSA involving BMW K1200LT motorcycles (with distinct vehicle
identification numbers) alleging final drive failures. These reports
were identified by searching NHTSA's database for all BMW complaints
(cars and motorcycles) and manually reviewing them for relevance. In
this way, NHTSA staff avoided searching too narrowly and identified
all potential complaints. Complaints that either mentioned a final
drive failure (even if the bearing wasn't identified) or described
an event appearing consistent with a final drive failure were
counted. In those instances where multiple failures were alleged,
only the ``first'' failure was counted. Duplicative reports were not
counted. Likewise NHTSA staff did not count those reports filed by
K1200LT owners simply expressing a ``concern'' that their final
drive might fail.
    The following tables represent the complaint data received by
NHTSA sorted by report year, vehicle model year, and incident year.
By report year, NHTSA found the following data in its database:

------------------------------------------------------------------------
                                                 Complaint
                  Report year                      count       Crashes
------------------------------------------------------------------------
2002..........................................           12            0
2003..........................................           27            0
2004..........................................           13            0
2005..........................................            9            0

2006..........................................           12            0
2007..........................................            8            0
2008..........................................            8            0
2009..........................................            8            0
2010..........................................            2            0
2011..........................................            2            0
2012..........................................           21            0
                                               -------------------------
    Total.....................................          122            0
------------------------------------------------------------------------

    By model year, NHTSA found the following data in its database:

------------------------------------------------------------------------
                                                 Complaint
                  Model year                       count       Crashes
------------------------------------------------------------------------
1999..........................................           39            0
2000..........................................           34            0
2001..........................................           16            0
2002..........................................           16            0
2003..........................................            9            0
2004..........................................            0            0
2005..........................................            4            0
2006..........................................            0            0
2007..........................................            1            0
2008..........................................            3            0
2009..........................................            0            0
2010..........................................            0            0
                                               -------------------------
    Total.....................................          122            0
------------------------------------------------------------------------

    By incident year, NHTSA found the following data in its
database:

------------------------------------------------------------------------
                                                 Complaint
                 Incident year                     count       Crashes
------------------------------------------------------------------------
1999..........................................            1            0
2000..........................................            1            0
2001..........................................            6            0
2002..........................................           12            0
2003..........................................           22            0
2004..........................................           14            0
2005..........................................           10            0
2006..........................................           14            0
2007..........................................            6            0
2008..........................................            8            0
2009..........................................           10            0
2010..........................................            6            0
2011..........................................            6            0
2012..........................................            6            0
                                               -------------------------
    Total.....................................          122            0
------------------------------------------------------------------------

5.4.1 The Petitioner's Complaint

    On December 6, 2011, NHTSA received a letter (dated November 28,
2011) from Mr. Christopher Cimino about his MY 2001 BMW K1200LT
motorcycle. In this letter, Mr. Cimino alleges he experienced two
failures of the final drive ring gear ball bearing on his
motorcycle. Mr. Cimino states that the first failure occurred in
December, 2008 at 59,310 miles and that he paid Engle Motors of
Kansas City (a BMW dealer) approximately $400 to repair the
motorcycle.\5\ Mr. Cimino further reports that his K1200LT sustained
a second alleged final drive crown gear bearing failure on October
21, 2011 at 75,994 miles. Mr. Cimino states that he had the
motorcycle repaired the second time by Coast Riders Powersports in
San Luis Obispo, CA (an independent motorcycle shop).
---------------------------------------------------------------------------

    \5\ Owners report a final drive repair or replacement cost
averaging approximately $1,400.
---------------------------------------------------------------------------

    Through subsequent contact with Mr. Cimino, the agency learned
that he had ridden his BMW K1200LT in multiple ``Iron Butt'' rallies
(www.ironbutt.com) and on the Barber race track at a Reg Pridmore
CLASS event (www.classrides.com).
    As with many K1200LT owners, Mr. Cimino claims that a crown gear
bearing failure results in a condition that poses a risk to rider
safety. Mr. Cimino also believes that if not for his ample riding
experience, he would have lost control of his motorcycle and a crash
would have occurred following the crown gear bearing failures he
experienced on his motorcycle.

5.4.2 Calendar Year 2012 Complaints To NHTSA

    On February 3, 2012, a posting by Mr. Cimino appeared on a
number of motorcycle-related internet forums.\6\ Within three hours,
NHTSA received the first of 21 ``new'' complaints for BMW K1200LT
final drive bearing failures. This count exceeded the number of
final drive bearing failure complaints NHTSA had received in the
previous 13 months.\7\
---------------------------------------------------------------------------

    \6\ For an example, see http://www.advrider.com/forums/showthread.php?t=761531.
    \7\ From January 1, 2011 to February 3, 2012, the agency
received two relevant reports . . . one was from Mr. Cimino.
---------------------------------------------------------------------------

    Below is a listing of the 21 complaints NHTSA received following
Mr. Cimino's internet forum posting:

----------------------------------------------------------------------------------------------------------------
                                                                         Failure
                Incident dte                  Recv'd dte    Model yr     mileage                Crash
----------------------------------------------------------------------------------------------------------------
6/21/11....................................       2/3/12         2003       143740  N
7/21/10....................................       2/3/12         2001        87000  N
3/14/11....................................       2/4/12         2002        58000  N
4/10/10....................................       2/4/12         2002        76244  N
12/6/08....................................       2/6/12         2003        30876  N
7/10/10....................................       2/8/12         2003        35116  N
5/18/10....................................       2/8/12         2000        38696  N
2/1/12.....................................      2/15/12         1999          Unk  N
2/2/06.....................................      2/21/12         1999          Unk  N
6/17/11....................................      2/24/12         1999        46000  N
2/25/12....................................       3/5/12         2008        42000  N
6/15/09....................................      3/13/12         2001        45151  N
7/15/11....................................       5/3/12         2005        23200  N
5/3/12.....................................       5/9/12         2000        87822  N
4/8/10.....................................       6/7/12         2002        57010  N
7/17/09....................................      6/29/12         1999        20500  N
5/1/09.....................................       7/5/12         2003        31555  N
8/24/12....................................      8/29/12         2000        37550  N
9/24/04....................................       9/6/12         1999        37290  N
5/15/12....................................     10/11/12         1999        42000  N
4/15/12....................................     10/22/12         2000        11500  N
----------------------------------------------------------------------------------------------------------------

6.0 NHTSA Analysis

    In assessing the petitioner's claim that a failure of the final
drive crown gear ball bearing unreasonably subjects BMW K1200LT
operators to a ``potential loss of [vehicle] control, possible
crash, injury and, if left unaddressed, eventual fatality,'' the
agency reviewed consumer complaints filed with NHTSA as well as
those posted on internet forums.
    When NHTSA became aware of the alleged defect in 2003, the
initial assessment was that, while final drive bearing failures
posed a customer satisfaction issue for BMW, the crash risk was
minimal. The subsequent nine years of subject motorcycle exposure
without a crash reported appear to validate NHTSA's initial
assessment. While the agency understands riders' concerns that a
final drive bearing failure may result in a crash, NHTSA has not
identified a single crash due to such a failure. NHTSA has found
that when a bearing failure does occur on a K1200LT (even in those
instances where the rider claims it was sudden and unforeseen),
riders are able to bring their motorcycle to a safe stop.

7.0 Conclusion

    Based on the foregoing analysis, it is unlikely that NHTSA would
issue an order to recall and remedy the alleged defect. In view of
that conclusion, the petition by Mr. Cimino is denied.

[FR Doc. 2013-13779 Filed 6-10-13; 8:45 am]
BILLING CODE 4910-59-P


[Federal Register Volume 82, Number 189 (Monday, October 2, 2017)]
[Notices]
[Pages 45863-45865]
[FR Doc No: 2017-21017]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-5442]

Leveraging Quantitative Methods and Modeling To Modernize Generic
Drug Development and Review; Public Workshop; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop; request for comments.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
announcing the following public workshop entitled ``Leveraging
Quantitative Methods and Modeling to Modernize Generic Drug Development
and Review.'' The purpose of the public workshop is to engage
stakeholders in a discussion of current and emerging scientific
approaches and applications for the conduct of quantitative modeling
and simulations in generic drug development, especially for complex and
locally acting products, and to gain input regarding opportunities and
knowledge gaps related to the use of quantitative modeling and
simulation to inform regulatory decision making through the product
lifecycle. FDA will use the information gained through the workshop to
support product-specific guidance development, improve pre-abbreviated
new drug applications (ANDA) interactions with applicants, increase the
quality and efficiency of regulatory reviews, and identify a next
generation modeling and simulation toolset for complex and locally
acting products.

DATES: The public workshop will be held on October 2 and 3, 2017, from
8:30 a.m. to 4:30 p.m. Submit either electronic or written comments on
this public workshop by November 3, 2017. See the SUPPLEMENTARY
INFORMATION section for registration date and information.

ADDRESSES: The public workshop will be held at FDA's White Oak Campus,
10903 New Hampshire Ave., Bldg. 31, Great Room, Silver Spring, MD
20993. Entrance for the public workshop participants (non-FDA
employees) is through Building 1 where routine security check
procedures will be performed. For parking and security information,
please refer to https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
    You may submit comments as follows. Please note that late, untimely
filed comments will not be considered. Electronic comments must be
submitted on or before November 3, 2017. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of November 3, 2017. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2017-N-5442 for ``Leveraging Quantitative Methods and Modeling to
Modernize Generic Drug Development and Review.'' Received comments,
those filed in a timely manner (see ADDRESSES), will be placed in the
docket and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the

``Search'' box and follow the prompts and/or go to the Dockets
Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Lanyan (Lucy) Fang, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 4686, Silver Spring, MD 20993, 301-796-
5005, email<EMAIL_ADDRESS>or Liang Zhao, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 4702, Silver Spring, MD 20993, 240-402-
4468, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    To enhance dialogue regarding modeling and simulation and
communication of recent advances in modeling and simulation, including
those supported by the Generic Drug User Fee Amendments regulatory
science research program, FDA plans to hold a public workshop to (1)
engage stakeholders in a discussion of current and emerging scientific
approaches and applications for the conduct of quantitative modeling
and simulations in generic drug development, especially for complex and
locally acting products, and (2) gain input regarding opportunities and
knowledge gaps related to the use of quantitative modeling and
simulation to inform regulatory decision making through the product
lifecycle.
    Modeling and simulation has been increasingly used in drug
development, providing a framework for synthesizing information and
extrapolating beyond what has been studied. Model-informed drug
development (MIDD) approaches can be applied to brand drug products
approved pursuant to a new drug application (NDA), and generic drug
products approved pursuant to an ANDA. MIDD holds particular promise in
key opportunity areas including pharmacokinetic/pharmacodynamics (PK/
PD) models, physiologically based pharmacokinetic (PBPK) or absorption
models, systems pharmacology, quantitative risk modeling, and emergent
machine learning tools. These application areas can leverage the large
pharmaceutical data sets (big data) available to FDA and other
organizations. Quantitative approaches have been used to address
significant scientific and regulatory issues in all phases of the
product lifecycle: from pre-investigational new drug applications
through NDAs, ANDAs, and post-approval evaluation of new and generic
drugs. Given the broad applications of modeling and simulation through
the entire lifecycle of a product, there is a need to identify best
practices to improve the routine use and acceptance of modeling and
simulation for regulatory decision making.
    The purposes of the workshop are to:
    (1) Engage global stakeholders and share experience and vision on
using quantitative approaches in regulatory decision making for generic
drug development and product lifecycle management;
    (2) Identify and prioritize potential areas for global
harmonization for tools to inform regulatory decision making;
    (3) Share the current state of knowledge and practice in utilizing
quantitative methods and modeling for generic drug development and
review by case demonstrations and by integrating experience and lessons
learned from new drug product development and reviews;
    (4) Identify opportunities for complex and locally acting product
development and discuss approaches and principles in using quantitative
methods and modeling to aid product-specific guidance development, pre-
ANDA interactions between FDA and prospective applicants, ANDA reviews,
and postmarket performance monitoring; and
    (5) Discuss next generation quantitative method and modeling
toolsets, future directions, and application areas beyond currently
available tools.
    There is a paradigm shift to a risk-based product-specific
regulatory approach for generic drugs. Examples of this transition
include recommendations for partial AUC (area under the concentration-
time curve) for some modified release drugs and replicate study
bioequivalence (BE) recommendations for narrow therapeutic index (NTI)
drugs. These product-specific guidances are driven by the therapeutic
significance of either the exposure-response relationships for safety
and efficacy (NTI drugs) or the difference in the shape of PK profiles.
Modeling and simulation toolsets direct the design and evaluation of PK
or comparative clinical endpoint BE studies, help evaluate clinical
endpoint sensitivity and feasibility, and enable the assessment of
alternative BE approaches. Overall, quantitative methods and modeling
support better and faster decisions during the generic drug development
and review process because they integrate knowledge accumulated during
and after new drug product development, including in vitro in vivo
correlation for formulation design, absorption, distribution,
metabolism, and excretion properties, population PK, and exposure-
response relationships for efficacy and safety.
    There is also a growing recognition that analysis of large datasets
helps organizations and individuals make better decisions. Emerging
methodologies that enable the Agency to take advantage of big data will
impact how generic drugs are developed, reviewed, and monitored.
Knowledge extracted from large datasets can provide FDA the opportunity
to improve the focus of regulatory review, modernize BE assessment
criteria, and efficiently manage workload by predicting future ANDA
applications. Further, such knowledge will support industry's efforts
to optimize their generic drug portfolios to meet upcoming patient and
market needs. The public workshop will focus on the use and advance of
quantitative methods and modeling in modernizing generic drug
development, regulatory review, and product lifecycle management.

II. Scope of Public Input Requested

    FDA seeks input on a range of topics related to the conduct of
modeling and simulation by pharmaceutical industries and by FDA and on
the interpretation and use of simulations for risk-based regulatory
assessment. They include:
    (1) Opportunity areas for model-informed generic drug development
and review
    (2) Risk-based BE standard for complex and locally acting products:
    a. Under what circumstances would alternative approaches to the
product-specific BE guidances be encouraged?
    b. What can serve as evidentiary data when proposing alternative BE
approaches?
    c. What are the scientific and regulatory challenges in using a
model-based BE approach?
    (3) Emerging quantitative methods and modeling in assisting
regulatory decision making for drug development and product life cycle
management:
    a. What are the areas (e.g., excipient selection, molecular target/
mechanism of action-safety profile association, universal exposure
response models for drugs with the same target) that can benefit most
in the big data era and what will be the regulatory impact and
implications?
    b. What are the potential new methods, including but not limited
to, machine learning and their application areas in assisting drug
development and review?
    (4) Post-approval evaluation of the substitutability of generic
products for

the corresponding reference listed drugs or reference standards:
    a. How to effectively integrate systems pharmacology, PBPK, and the
exposure-clinical response relationship to evaluate product risk and
assist BE evaluation?
    b. What will be the next generation methodologies in postmarket
signal detection to evaluate product substitution or compare product
performance using the Sentinel database or complementary toolsets?

III. Participating in the Public Workshop

    Registration: Persons interested in attending this public workshop
must register online at https://survey.co1.qualtrics.com/jfe/form/SV_3eiJOCsnrPdTZU9. Please provide complete contact information for
each attendee, including name, title, affiliation, address, email, and
telephone.
    Registration is free and based on space availability, with priority
given to early registrants. Persons interested in attending this public
workshop must register by September 25, 2017, midnight, Eastern
Standard Time. Early registration is recommended because seating is
limited; therefore, FDA may limit the number of participants from each
organization.
    If you need special accommodations due to a disability, please
contact Lanyan (Lucy) Fang (see FOR FURTHER INFORMATION CONTACT) no
later than 7 days before the workshop.
    Requests for Oral Presentations: During online registration you may
indicate if you wish to present during a public comment session, and
which topic(s) you wish to address. We will do our best to accommodate
requests to make public comments. Individuals and organizations with
common interests are urged to consolidate or coordinate their
presentations, and to request time for a joint presentation, or to
submit requests for designated representatives to participate in the
focused sessions. Following the close of registration, we will
determine the amount of time allotted to each presenter and the
approximate time each oral presentation is to begin, and will select
and notify participants by September 27, 2017. All requests to make
oral presentations must be received by the close of registration on
September 25, 2017. If selected for presentation, any presentation
materials must be emailed to Lanyan (Lucy) Fang (see FOR FURTHER
INFORMATION CONTACT) no later than September 28, 2017. No commercial or
promotional material will be permitted to be presented or distributed
at the public workshop.
    Streaming Webcast of the Public Workshop: This public workshop will
also be webcast. A live webcast of this workshop will be viewable at
https://collaboration.fda.gov/dqmm1017/on the day of the workshop.
    If you have never attended a Connect Pro event before, test your
connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. To get a quick overview of the Connect Pro program,
visit https://www.adobe.com/go/connectpro_overview. FDA has verified
the Web site addresses in this document, as of the date this document
publishes in the Federal Register, but Web sites are subject to change
over time.
    Transcripts: Please be advised that as soon as a transcript of the
public workshop is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Dockets Management Staff
(see ADDRESSES). A link to the transcript will also be available on the
internet at http://www.fda.gov/Drugs/NewsEvents/ucm554182.htm.

    Dated: September 26, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-21017 Filed 9-29-17; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register: June 23, 2010 (Volume 75, Number 120)]
[Rules and Regulations]
[Page 35613-35616]
[DOCID:fr23jn10-4]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2009-0995; Directorate Identifier 2009-NM-123-AD;
Amendment 39-16336; AD 2010-13-05]
RIN 2120-AA64

Airworthiness Directives; Bombardier, Inc. Model CL-600-2C10
(Regional Jet Series 700 & 701) Airplanes, Model CL-600-2D15 (Regional
Jet Series 705) Airplanes, and Model CL-600-2D24 (Regional Jet Series
900) Airplanes

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Final rule.

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

SUMMARY: We are adopting a new airworthiness directive (AD) for the
products listed above. This AD results from mandatory continuing
airworthiness information (MCAI) originated by an aviation authority of
another country to identify and correct an unsafe condition on an
aviation product. The MCAI describes the unsafe condition as:

    Investigation into a landing gear retraction problem on a
production test flight revealed that, during aircraft pressurization
and depressurization cycles, the pressure floor in the main landing
gear bay deflects to a small extent. This causes relative
misalignment between the [alternate-extension system] AES bypass
valve, the downlock assist valve and the summing lever which, in
turn, can result in damage to and potential failure of the
respective clevis attached to one or both of the valves. Such a
clevis failure could remain dormant and, in the subsequent event
that use of the AES was required, full landing gear extension may
not be achievable.
* * * * *
    We are issuing this AD to require actions to correct the unsafe
condition on these products.

DATES: This AD becomes effective June 23, 2010.
    The Director of the Federal Register approved the incorporation by
reference of certain publications listed in this AD as of July 28,
2010.

ADDRESSES: You may examine the AD docket on the Internet at http://
www.regulations.gov or in person at the U.S. Department of
Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE., Washington, DC.

FOR FURTHER INFORMATION CONTACT: Cesar Gomez, Aerospace Engineer,
Airframe and Mechanical Systems Branch, ANE-171, FAA, New York Aircraft
Certification Office, 1600 Stewart Avenue, Suite 410, Westbury, New
York 11590; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 to include an AD that would apply to the specified products.
That NPRM was published in the Federal Register on October 28, 2009 (74
FR 55493). That NPRM proposed to correct an unsafe condition for the
specified products. The MCAI states:

    Investigation into a landing gear retraction problem on a
production test flight revealed that, during aircraft pressurization
and depressurization cycles, the pressure floor in the main landing
gear bay deflects to a small extent. This causes relative
misalignment between the [alternate-extension system] AES bypass
valve, the downlock assist valve and the summing lever which, in
turn, can result in damage to and potential failure of the
respective clevis attached to one or both of the valves. Such a
clevis failure could remain dormant and, in the subsequent event
that use of the AES was required, full landing gear extension may
not be achievable.
    This directive gives instructions to replace the clevis, with a
new part, for both the bypass and the downlock assist valves. It
also gives instructions to install new support brackets for both
valves, in order to increase the stiffness of the installations and
thus prevent future relative misalignment and potential clevis
failure.

    You may obtain further information by examining the MCAI in the AD
docket.

Comments

    We gave the public the opportunity to participate in developing
this AD. We considered the comments received.

Support for the NPRM

    The Air Line Pilots Association, International (ALPA), supports the
NPRM.

Request To Allow Repetitive Clevis Replacements in Lieu of Support
Bracket Replacement

    Comair, Inc., requests that we revise the NPRM to allow repetitive
replacement of the bypass valve clevis and downlock assist valve clevis
at 6,000-flight-cycle intervals, until the new support brackets have
been installed instead of requiring installation of the support
brackets at the compliance times specified in paragraph (f)(3) of this
AD. Comair, Inc., explains that Bombardier Alert Service Bulletin
A670BA-32-022, dated November 8, 2007, established an initial
replacement of the clevises along with a repetitive replacement every
6,000 flight cycles. But with the introduction of Part C of Bombardier
Alert Service Bulletin A670BA-32-022, Revision A, dated May 1, 2009,
Comair, Inc., asserts that the repetitive interval was removed.
    Comair, Inc., states that it initiated the compliance with Parts A
and B of Bombardier Alert Service Bulletin A670BA-32-022, dated
November 8, 2007, in early 2008. Since the initial compliance time,
Comair, Inc., states that nearly 2,900 flight cycles have passed and
reasons that by the time the NPRM becomes a final rule, 500 or more
flight cycles might pass. Comair, Inc., also explains that because of
the proposed compliance times specified in paragraphs (f)(3)(ii) and
(f)(3)(iii) of the NPRM, the installation of the new support brackets
will be required within approximately 2,600 flight cycles (6,000 flight
cycles minus 3,400 cycles).
    Comair, Inc., asserts that limiting installation of the new support
brackets to 2,600 flight cycles instead of 4,500 flight cycles, as
proposed by paragraph (f)(3)(i) of the NPRM, penalizes those operators
who have taken early action to comply with Bombardier Alert Service
Bulletin A670BA-32-022. To compensate for the loss of flight cycles,
Comair, Inc., suggests that we revise paragraphs (f)(1) and (f)(2) of
the NPRM to state: ``* * * Replacement of the clevises each 6,000
flight cycles from the initial replacement, in order to

extend the compliance schedule in paragraph (f)(3) is acceptable.''
    We do not agree to allow repetitive replacements of the bypass
valve clevis and downlock assist valve clevis until the new support
bracket is installed. Comair, Inc., noted that the compliance time in
paragraph (f)(3)(i) of the NPRM is 4,500 flight cycles; however, the
compliance time is 4,500 flight hours. Operators that do the clevis
replacement and operators that are not required to replace the clevis
both have to comply with the 4,500 flight-hour compliance time to
install the support brackets if that compliance time occurs first.
    However, we recognize the concern of Comair, Inc., in that the
compliance time specified in paragraphs (f)(3)(ii) and (f)(3)(iii) of
the NPRM (within 6,000 flight cycles after doing the clevis replacement
or within 600 flight cycles after the effective date of this AD)
penalizes those operators who have taken early action to comply with
replacing the clevis in accordance with Bombardier Alert Service
Bulletin A670BA-32-022, dated November 8, 2007. Therefore, we have
increased the grace period specified in paragraphs (f)(3)(ii) and
(f)(3)(iii) of this AD to allow operators that did the clevis
replacement before the effective date of this AD additional time to do
the installation of the bracket. We have determined that extending the
grace period will not adversely affect safety and meets the intent of
the MCAI, Canadian Airworthiness Directive CF-2009-22, dated May 14,
2009. We have coordinated this change with Transport Canada Civil
Aviation (TCCA).
    Under the provisions of paragraph (g) of the final rule, we will
consider requests for approval of an extension of the compliance time
for the installation of the new support brackets if sufficient data are
submitted to substantiate that the new compliance time would provide an
acceptable level of safety. We have not changed the AD in this regard.

Explanation of Change to This AD

    We have revised this AD to identify the legal name of the
manufacturer as published in the most recent type certificate data
sheet for the affected airplane models.

Conclusion

    We reviewed the available data, including the comments received,
and determined that air safety and the public interest require adopting
the AD with the change described previously. We determined that this
change will not increase the economic burden on any operator or
increase the scope of the AD.

Differences Between This AD and the MCAI or Service Information

    We have reviewed the MCAI and related service information and, in
general, agree with their substance. But we might have found it
necessary to use different words from those in the MCAI to ensure the
AD is clear for U.S. operators and is enforceable. In making these
changes, we do not intend to differ substantively from the information
provided in the MCAI and related service information.
    We might also have required different actions in this AD from those
in the MCAI in order to follow our FAA policies. Any such differences
are highlighted in a NOTE within the AD.

Explanation of Change to Costs of Compliance

    Since issuance of the NPRM, we have increased the labor rate used
in the Costs of Compliance from $80 per work-hour to $85 per work-hour.
The Costs of Compliance information, below, reflects this increase in
the specified hourly labor rate.

Costs of Compliance

    We estimate that this AD will affect 203 products of U.S. registry.
We also estimate that it will take about 12 work-hours per product to
comply with the basic requirements of this AD. The average labor rate
is $85 per work-hour. Required parts will cost about $939 per product.
Where the service information lists required parts costs that are
covered under warranty, we have assumed that there will be no charge
for these parts. As we do not control warranty coverage for affected
parties, some parties may incur costs higher than estimated here. Based
on these figures, we estimate the cost of this AD to U.S. operators to
be $397,677, or $1,959 per product.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. ``Subtitle VII: Aviation
Programs,'' describes in more detail the scope of the Agency's
authority.
    We are issuing this rulemaking under the authority described in
``Subtitle VII, Part A, Subpart III, Section 44701: General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    We determined that this 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 this AD:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979); 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.
    We prepared a regulatory evaluation of the estimated costs to
comply with this AD and placed it in the AD docket.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://
www.regulations.gov; or in person at the Docket Operations office
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains the NPRM, the regulatory evaluation,
any comments received, and other information. The street address for
the Docket Operations office (telephone<PHONE_NUMBER>) is in the
ADDRESSES section. Comments will be available in the AD docket shortly
after receipt.

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

0
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 AD:

2010-13-05 Bombardier, Inc.: Amendment 39-16336. Docket No. FAA-
2009-0995; Directorate Identifier 2009-NM-123-AD.

Effective Date

    (a) This airworthiness directive (AD) becomes effective July 28,
2010.

Affected ADs

    (b) None.

Applicability

    (c) This AD applies to the airplanes identified in paragraphs
(c)(1) and (c)(2) of this AD, certificated in any category.
    (1) Bombardier, Inc. Model CL-600-2C10 (Regional Jet Series 700
& 701) airplanes, serial numbers 10003 through 10216 inclusive.
    (2) Bombardier, Inc. Model CL-600-2D15 (Regional Jet Series 705)
and Model CL-600-2D24 (Regional Jet Series 900) airplanes, serial
numbers 15001 through 15039 inclusive.

Subject

    (d) Air Transport Association (ATA) of America Code 32: Landing
Gear.

Reason

    (e) The mandatory continuing airworthiness information (MCAI)
states:

    Investigation into a landing gear retraction problem on a
production test flight revealed that, during aircraft pressurization
and depressurization cycles, the pressure floor in the main landing
gear bay deflects to a small extent. This causes relative
misalignment between the [alternate-extension system] AES bypass
valve, the downlock assist valve and the summing lever which, in
turn, can result in damage to and potential failure of the
respective clevis attached to one or both of the valves. Such a
clevis failure could remain dormant and, in the subsequent event
that use of the AES was required, full landing gear extension may
not be achievable.
    This directive gives instructions to replace the clevis, with a
new part, for both the bypass and the downlock assist valves. It
also gives instructions to install new support brackets for both
valves, in order to increase the stiffness of the installations and
thus prevent future relative misalignment and potential clevis
failure.

Actions and Compliance

    (f) Unless already done, do the following actions.
    (1) For any bypass valve having part number (P/N) 53342-3, at
the applicable time in paragraph (f)(1)(i), (f)(1)(ii), or
(f)(1)(iii) of this AD, replace the existing clevis with a new
clevis having P/N 2323H037, in accordance with Part A of the
Accomplishment Instructions of Bombardier Alert Service Bulletin
A670BA-32-022, Revision A, dated May 1, 2009. The replacement is not
required if paragraph (f)(3) of this AD has already been done.
    (i) If the bypass valve has accumulated 9,400 total flight
cycles or fewer as of the effective date of this AD, replace the
clevis before the accumulation of 10,000 total flight cycles on the
valve.
    (ii) If the bypass valve has accumulated more than 9,400 total
flight cycles as of the effective date of this AD, replace the
clevis within 550 flight hours after the effective date of this AD.
    (iii) If it is not possible to determine the total flight cycles
accumulated on the bypass valve, replace the clevis within 550
flight hours after the effective date of this AD.
    (2) For any downlock assist valve having P/N 53341-5, at the
applicable time in paragraph (f)(2)(i), (f)(2)(ii), or (f)(2)(iii)
of this AD, replace the existing clevis with a new clevis, having P/
N 2323H037, in accordance with Part B of the Accomplishment
Instructions of Bombardier Alert Service Bulletin A670BA-32-022,
Revision A, dated May 1, 2009. The replacement is not required if
paragraph (f)(3) of this AD has already been done.
    (i) If the valve has accumulated 9,400 total flight cycles or
fewer as of the effective date of this AD, replace the clevis before
the valve has accumulated 10,000 total flight cycles on the valve.
    (ii) If the valve has accumulated more than 9,400 total flight
cycles as of the effective date of this AD, replace the clevis
within 550 flight hours after the effective date of this AD.
    (iii) If it is not possible to determine the total flight cycles
accumulated by the downlock assist valve, replace the clevis within
550 flight hours after the effective date of this AD.
    (3) At the earliest of the times in paragraphs (f)(3)(i),
(f)(3)(ii), and (f)(3)(iii) of this AD, install new support brackets
for the bypass valve and downlock assist valve, in accordance with
Part C of the Accomplishment Instructions of Bombardier Alert
Service Bulletin A670BA-32-022, Revision A, dated May 1, 2009.
Installing the support brackets terminates the requirements of
paragraphs (f)(1) and (f)(2) of this AD.
    (i) Within 4,500 flight hours after the effective date of this
AD.
    (ii) Within 6,000 flight cycles after accomplishing the actions
specified in paragraph (f)(1) of this AD, or 6,000 flight cycles
after the effective date of this AD, whichever occurs later.
    (iii) Within 6,000 flight cycles after accomplishing the actions
specified in paragraph (f)(2) of this AD, or 6,000 flight cycles
after the effective date of this AD, whichever occurs later.
    (4) Replacing the clevises for the bypass valve and downlock
assist valve before the effective date of this AD, in accordance
with the Accomplishment Instructions of Bombardier Alert Service
Bulletin A670BA-32-022, dated November 8, 2007, is considered
acceptable for compliance with the corresponding actions specified
in paragraphs (f)(1) and (f)(2) of this AD.

FAA AD Differences

    Note 1: This AD differs from the MCAI and/or service information
as follows: No differences.

Other FAA AD Provisions

    (g) The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager, New
York Aircraft Certification Office (ACO), ANE-170, FAA, has the
authority to approve AMOCs for this AD, if requested using the
procedures found in 14 CFR 39.19. Send information to Attn: Program
Manager, Continuing Operational Safety, FAA, New York ACO, 1600
Stewart Avenue, Suite 410, Westbury, New York 11590; telephone 516-
228-7300; fax<PHONE_NUMBER>. Before using any approved AMOC on any
airplane to which the AMOC applies, notify your principal
maintenance inspector (PMI) or principal avionics inspector (PAI),
as appropriate, or lacking a principal inspector, your local Flight
Standards District Office. The AMOC approval letter must
specifically reference this AD.
    (2) Airworthy Product: For any requirement in this AD to obtain
corrective actions from a manufacturer or other source, use these
actions if they are FAA-approved. Corrective actions are considered
FAA-approved if they are approved by the State of Design Authority
(or their delegated agent). You are required to assure the product
is airworthy before it is returned to service.
    (3) Reporting Requirements: For any reporting requirement in
this AD, under the provisions of the Paperwork Reduction Act (44
U.S.C. 3501 et seq.), the Office of Management and Budget (OMB) has
approved the information collection requirements and has assigned
OMB Control Number 2120-0056.

Related Information

    (h) Refer to MCAI Canadian Airworthiness Directive CF-2009-22,
dated May 14, 2009; and Bombardier Alert Service Bulletin A670BA-32-
022, Revision A, dated May 1, 2009; for related information.

Material Incorporated by Reference

    (i) You must use Bombardier Alert Service Bulletin A670BA-32-
022, Revision A, including Appendix A, dated May 1, 2009, to do the
actions required by this AD, unless the AD specifies otherwise. (The
revision level is not specified on pages A1 and A2, Appendix A, of
this document; those pages are Revision A, dated May 1, 2009.)
    (1) The Director of the Federal Register approved the
incorporation by reference of this service information under 5
U.S.C. 552(a) and 1 CFR part 51.
    (2) For service information identified in this AD, contact
Bombardier, Inc., 400 C[ocirc]te-Vertu Road West, Dorval,
Qu[eacute]bec H4S 1Y9, Canada; telephone<PHONE_NUMBER>; fax 514-855-
7401; e-mail<EMAIL_ADDRESS>Internet http://
www.bombardier.com.
    (3) You may review copies of the service information at the FAA,
Transport Airplane Directorate, 1601 Lind Avenue, SW., Renton,
Washington. For information on the availability of this material at
the FAA, call<PHONE_NUMBER>.
    (4) You may also review copies of the 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, call<PHONE_NUMBER>, or go to: http://
www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.

    Issued in Renton, Washington, on June 10, 2010.
Jeffrey E. Duven,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2010-14979 Filed 6-22-10; 8:45 am]
BILLING CODE 4910-13-P