Airworthiness Directives; Bombardier, Inc., Airplanes, 52644-52647 [2017-24166]
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52644
Federal Register / Vol. 82, No. 218 / Tuesday, November 14, 2017 / Rules and Regulations
reviewing the rulemaking record for the
OLPP final rule, AMS discovered a
significant, material error in the
mathematical calculation of the benefits
estimates. With the material error, the
regulatory impact analysis presented
costs and benefits in a table that could
be reasonably interpreted to conclude
that benefits were likely to exceed the
costs. (82 FR 7083–82 FR 7084.)
However, AMS believes that the
regulatory impact analysis’ calculation
of benefits was flawed because the
incorrect calculation was applied for the
3 percent and 7 percent discount rates.
Re-analysis using the correct
mathematical calculations suggests that
this error was material. It is not
appropriate for AMS to allow a final
rule to become effective based on a
record containing such a material error.
AMS intends to seek public comment
on the revised calculation of benefits.
Due to these significant concerns
regarding statutory authority for, and
costs and benefits of, the OLPP rule,
including the question whether the
OLPP final rule was based on a
mathematically flawed assessment of
benefits, AMS is selecting Option 3:
Delay. AMS is issuing this final rule to
further delay the effective date for until
May 14, 2018 to allow for AMS to issue
another notice of proposed rulemaking
to receive comments on USDA statutory
authority under the OFPA to regulate
animal welfare; the likely costs and
benefits of the OLPP rule viewed in
terms of the statutory objectives of the
OPFA, as interpreted above; whether the
OLPP rule’s requirements represent the
most innovate and least burdensome
way to achieve regulatory ends; and the
revised calculations and analysis of the
benefits of the OLPP rule. This delay
will provide additional time for AMS to
solicit comment on these important
issues and review all the comments
prior to making a final decision on the
direction of the OLPP final rule.
To preserve the status quo rather than
allow an expansive set of new
requirements to become effective only to
be delayed, suspended, or withdrawn a
short time later and to allow AMS to
receive and consider comments on the
issues discussed above, this final rule
action is effective upon publication
because AMS believes that the 30-day
delay is impracticable, unnecessary, and
contrary to the public interest. When
agencies establish good cause for an
immediate effective date, Congress
intended that, combined with
unavoidable time limitations, ‘‘the
primary consideration was to be the
‘convenience or necessity of the people
affected.’ ’’ United States v. Gavrilovic,
551 F.2d 1099, 1104 (8th Cir. 1977)
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(citing S.Rep.No.752, 79th Cong., 1st
Sess. 15 (1946); H.R.Rep.No.1980, 79th
Cong., 2d Sess. 25 (1946)). Ordinarily,
the thirty-day waiting period gives
stakeholders and the public a reasonable
time to adjust behavior. Omnipoint
Corp. v. F.C.C., 78 F.3d 620, 630 (D.C.
Cir. 1996). In this case, however, a
thirty-day waiting period would require
stakeholders to begin changing their
behavior to comply with the OLPP final
rule, when that rule may be delayed,
suspended, or withdrawn after the
agency has completed review of
comments in response to an notice of
proposed rulemaking that will present
the issues discussed above. It is also
contrary to the public interest to allow
a final rule that is based on a flawed
record to become effective. Thus, and
for the reasons stated above, waiting for
thirty days to delay the effective date of
the OLPP final rule is not warranted by
‘‘convenience’’ and would be
unnecessary and contrary to the public
interest.
Dated: November 8, 2017.
Sonia N. Jimenez,
Acting Associate Administrator, Agricultural
Marketing Service.
[FR Doc. 2017–24675 Filed 11–9–17; 8:45 am]
BILLING CODE 3410–02–P
DEPARTMENT OF TRANSPORTATION
Federal Aviation Administration
14 CFR Part 39
[Docket No. FAA–2017–0712; Product
Identifier 2017–NM–014–AD; Amendment
39–19095; AD 2017–23–01]
RIN 2120–AA64
Airworthiness Directives; Bombardier,
Inc., Airplanes
Federal Aviation
Administration (FAA), Department of
Transportation (DOT).
ACTION: Final rule.
AGENCY:
We are superseding
Airworthiness Directive (AD) 2016–13–
14, which applied to certain
Bombardier, Inc., Model DHC–8–400
series airplanes. AD 2016–13–14
required an inspection to determine if
certain left and right main landing gear
(MLG) retract actuator rod ends were
installed, repetitive liquid penetrant
inspections (LPIs) of affected left and
right MLG retract actuator rod ends, and
corrective actions if necessary. This new
AD retains the actions specified in AD
2016–13–14 and also requires
replacement of the left and right MLG
retract actuator rod ends. This AD was
SUMMARY:
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prompted by a report of a cracked MLG
retract actuator rod end. We are issuing
this AD to address the unsafe condition
on these products.
DATES: This AD is effective December
19, 2017.
The Director of the Federal Register
approved the incorporation by reference
of a certain publication listed in this AD
as of July 20, 2016 (81 FR 43481, July
5, 2016).
ADDRESSES: For service information
identified in this final rule, contact
Bombardier, Inc., Q-Series Technical
Help Desk, 123 Garratt Boulevard,
Toronto, Ontario M3K 1Y5, Canada;
telephone: 416–375–4000; fax: 416–
375–4539; email: thd.qseries@
aero.bombardier.com; Internet: https://
www.bombardier.com. You may view
this referenced service information at
the FAA, Transport Standards Branch,
1601 Lind Avenue SW., Renton, WA.
For information on the availability of
this material at the FAA, call 425–227–
1221. It is also available on the Internet
at https://www.regulations.gov by
searching for and locating Docket No.
FAA–2017–0712.
Examining the AD Docket
You may examine the AD docket on
the Internet at https://
www.regulations.gov by searching for
and locating Docket No. FAA–2017–
0712; or in person at the Docket
Management Facility between 9 a.m.
and 5 p.m., Monday through Friday,
except Federal holidays. The AD docket
contains this AD, the regulatory
evaluation, any comments received, and
other information. The address for the
Docket Office (telephone: 800–647–
5527) is Docket Management Facility,
U.S. Department of Transportation,
Docket Operations, M–30, West
Building Ground Floor, Room W12–140,
1200 New Jersey Avenue SE.,
Washington, DC 20590.
FOR FURTHER INFORMATION CONTACT: Aziz
Ahmed, Aerospace Engineer, Airframe
and Mechanical Systems Section, FAA,
New York ACO Branch, 1600 Stewart
Avenue, Suite 410, Westbury, NY
11590; telephone: 516–228–7329; fax:
516–794–5531.
SUPPLEMENTARY INFORMATION:
Discussion
We issued a notice of proposed
rulemaking (NPRM) to amend 14 CFR
part 39 to supersede AD 2016–13–14,
Amendment 39–18579 (81 FR 43481,
July 5, 2016) (‘‘AD 2016–13–14’’). AD
2016–13–14 applied to certain
Bombardier, Inc., Model DHC–8–400
series airplanes. The NPRM published
in the Federal Register on July 28, 2017
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Federal Register / Vol. 82, No. 218 / Tuesday, November 14, 2017 / Rules and Regulations
(82 FR 35127). The NPRM was
prompted by a report of a cracked MLG
retract actuator rod end. The NPRM
proposed to continue to require the
actions specified in AD 2016–13–14.
The NPRM also proposed to require
replacement of the left and right MLG
retract actuator rod ends. We are issuing
this AD to detect and correct fatigue
cracking of the left and right MLG
retract actuator rod ends, which could
lead to left or right MLG collapse.
Transport Canada Civil Aviation
(TCCA), which is the aviation authority
for Canada, has issued Canadian AD
CF–2016–16R1, dated June 27, 2016
(referred to after this as the Mandatory
Continuing Airworthiness Information,
or ‘‘the MCAI’’), to correct an unsafe
condition for certain Bombardier, Inc.
Model DHC–8–400 series airplanes. The
MCAI states:
There has been a single reported case of a
cracked MLG retract actuator rod end in
service. A supplier disclosure letter and
subsequent Bombardier analysis indicate that
the MLG retract actuator rod end P/N [part
number] P3A2750 and P3A2750–1 may
develop fatigue cracking. This condition, if
not corrected, could lead to left hand (LH) or
right hand (RH) MLG collapse.
This [Canadian] AD mandates the
inspection [to determine if certain left and
right main landing gear MLG retract actuator
rod ends are installed, repetitive LPIs of
affected left and right MLG retract actuator
rod ends, and corrective actions if necessary],
and replacement of the LH and RH MLG
retract actuator rod ends P/N P3A2750 and
P3A2750–1 [which is terminating action for
the repetitive LPIs].
This [Canadian] AD was revised to clarify
paragraph B. and C. [of this Canadian AD],
which specifies when the Liquid Penetrant
Inspections (LPI) should begin.
Corrective actions include replacing
cracked MLG retract actuator rod ends.
You may examine the MCAI in the AD
docket on the Internet at https://
www.regulations.gov by searching for
and locating Docket No. FAA–2017–
0712.
Comments
We gave the public the opportunity to
participate in developing this AD. We
received no comments on the NPRM or
on the determination of the cost to the
public.
jstallworth on DSKBBY8HB2PROD with RULES
Conclusion
We reviewed the available data and
determined that air safety and the
public interest require adopting this AD
as proposed except for minor editorial
changes. We have determined that these
minor changes:
• Are consistent with the intent that
was proposed in the NPRM for
correcting the unsafe condition; and
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• Do not add any additional burden
upon the public than was already
proposed in the NPRM.
Related Service Information Under
1 CFR Part 51
Bombardier, Inc., has issued
Bombardier Service Bulletin 84–32–142,
dated May 4, 2016. This service
information describes procedures for an
inspection to determine if certain left
and right MLG retract actuator rod ends
are installed, repetitive LPIs of the left
and right MLG retract actuator rod ends,
and replacement of left and right MLG
retract actuator rod ends. This service
information is reasonably available
because the interested parties have
access to it through their normal course
of business or by the means identified
in the ADDRESSES section.
Costs of Compliance
We estimate that this AD affects 52
airplanes of U.S. registry.
We estimate the following costs to
comply with this AD:
The actions required by AD 2016–13–
14, and retained in this AD, take about
1 work-hour per product, at an average
labor rate of $85 per work-hour. Based
on these figures, the estimated cost of
the inspection that is required by AD
2016–13–14 is $85 per product.
We also estimate that it will take
about 3 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 $2,019 per product. Based on
these figures, we estimate the cost of
this AD on U.S. operators to be
$118,248, or $2,274 per product.
In addition, we estimate that any
necessary follow-on actions will take
about 3 work-hours and require parts
costing $2,019, for a cost of $2,274 per
product. We have no way of
determining the number of aircraft that
might need these actions.
According to the manufacturer, some
of the costs of this AD may be covered
under warranty, thereby reducing the
cost impact on affected individuals. We
do not control warranty coverage for
affected individuals. As a result, we
have included all available costs in our
cost estimate.
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.
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52645
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.
This AD is issued in accordance with
authority delegated by the Executive
Director, Aircraft Certification Service,
as authorized by FAA Order 8000.51C.
In accordance with that order, issuance
of ADs is normally a function of the
Compliance and Airworthiness
Division, but during this transition
period, the Executive Director has
delegated the authority to issue ADs
applicable to transport category
airplanes to the Director of the System
Oversight Division.
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 that 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);
3. Will not affect intrastate aviation in
Alaska; and
4. Will not have a significant
economic impact, positive or negative,
on a substantial number of small entities
under the criteria of the Regulatory
Flexibility Act.
List of Subjects in 14 CFR Part 39
Air transportation, Aircraft, Aviation
safety, Incorporation by reference,
Safety.
Adoption of the Amendment
Accordingly, under the authority
delegated to me by the Administrator,
the FAA amends 14 CFR part 39 as
follows:
PART 39—AIRWORTHINESS
DIRECTIVES
1. The authority citation for part 39
continues to read as follows:
■
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52646
Federal Register / Vol. 82, No. 218 / Tuesday, November 14, 2017 / Rules and Regulations
Authority: 49 U.S.C. 106(g), 40113, 44701.
§ 39.13
[Amended]
2. The FAA amends § 39.13 by
removing Airworthiness Directive (AD)
2016–13–14, Amendment 39–18579 (81
FR 43481, July 5, 2016), and adding the
following new AD:
■
2017–23–01 Bombardier, Inc.: Amendment
39–19095; Docket No. FAA–2017–0712;
Product Identifier 2017–NM–014–AD.
(a) Effective Date
This AD is effective December 19, 2017.
(b) Affected ADs
This AD replaces AD 2016–13–14,
Amendment 39–18579 (81 FR 43481, July 5,
2016) (‘‘AD 2016–13–14’’).
(c) Applicability
This AD applies to Bombardier, Inc.,
Model DHC–8–400, –401 and –402 airplanes,
certificated in any category, serial numbers
4001, and 4003 through 4325 inclusive.
(d) Subject
Air Transport Association (ATA) of
America Code 32, Landing gear.
(e) Reason
This AD was prompted by a report of a
cracked main landing gear (MLG) retract
actuator rod end. We are issuing this AD to
detect and correct fatigue cracking of the left
and right MLG retract actuator rod ends,
which could lead to left or right MLG
collapse.
(f) Compliance
Comply with this AD within the
compliance times specified, unless already
done.
jstallworth on DSKBBY8HB2PROD with RULES
(g) Retained Part Number Inspection, With
No Changes
This paragraph restates the requirements of
paragraph (g) of AD 2016–13–14, with no
changes. Within 100 flight cycles after July
20, 2016 (the effective date of AD 2016–13–
14), inspect the left and right MLG retract
actuator rod ends to determine if part number
(P/N) P3A2750 or P3A2750–1 is installed. A
review of airplane maintenance records is
acceptable in lieu of this inspection if the
part number can be conclusively determined
from that review.
(h) Retained Repetitive Liquid Penetrant
Inspections (LPIs), With No Changes
This paragraph restates the requirements of
paragraph (h) of AD 2016–13–14, with no
changes. For each left or right MLG retract
actuator rod end having P/N P3A2750 or
P3A2750–1: At the applicable time specified
in paragraph (h)(1) or (h)(2) of this AD, do
an LPI to detect cracks of the MLG retract
actuator rod end, in accordance with the
Accomplishment Instructions of Bombardier
Service Bulletin 84–32–142, dated May 4,
2016, except as required by paragraph (k) of
this AD. Thereafter, repeat the LPI at
intervals not to exceed 600 flight cycles.
(1) If the MLG retract actuator rod end has
accumulated more than 6,000 flight cycles as
of July 20, 2016 (the effective date of AD
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13:31 Nov 13, 2017
Jkt 244001
2016–13–14): Inspect within 100 flight cycles
after July 20, 2016.
(2) If the MLG retract actuator rod end has
accumulated 6,000 flight cycles or fewer as
of July 20, 2016 (the effective date of AD
2016–13–14): Inspect within 600 flight cycles
after July 20, 2016.
(i) Retained Corrective Action, With No
Changes
This paragraph restates the requirements of
paragraph (i) of AD 2016–13–14, with no
changes. If any crack is found during any
inspection required by paragraph (h) of this
AD, before further flight, replace the cracked
MLG retract actuator rod end, P/N P3A2750
or P3A2750–1, with a MLG retract actuator
rod end, P/N P3A6460, in accordance with
the Accomplishment Instructions of
Bombardier Service Bulletin 84–32–142,
dated May 4, 2016, except as required by
paragraph (k) of this AD.
(j) Retained Optional Replacement, With No
Changes
This paragraph restates the optional
replacement specified in paragraph (j) of AD
2016–13–14, with no changes. Replacement
of the left and right side MLG retract actuator
rod ends, P/N P3A2750 or P3A2750–1, with
left and right MLG retract actuator rod ends,
P/N P3A6460, in accordance with the
Accomplishment Instructions of Bombardier
Service Bulletin 84–32–142, dated May 4,
2016, except as required by paragraph (k) of
this AD, constitutes terminating action for
the actions required by paragraphs (g) and (h)
of this AD for that airplane.
(k) Retained Exception, With No Changes
This paragraph restates the requirements of
paragraph (k) of AD 2016–13–14, with no
changes. If it is not possible to complete all
the instructions in Bombardier Service
Bulletin 84–32–142, dated May 4, 2016,
because of the configuration of the airplane:
Before further flight, repair using a method
approved by the Manager, New York ACO
Branch, FAA; or Transport Canada Civil
Aviation (TCCA); or Bombardier, Inc.’s TCCA
Design Approval Organization (DAO).
(l) Retained Parts Installation Prohibition,
With No Changes
This paragraph restates the requirements of
paragraph (l) of AD 2016–13–14, with no
changes. As of July 20, 2016 (the effective
date of AD 2016–13–14), no person may
install a left or right MLG retract actuator rod
end, P/N P3A2750 or P3A2750–1, on any
airplane.
(m) New Requirement of This AD:
Replacement
Within 1,800 flight cycles after
accomplishing the initial inspection required
by paragraph (g) of this AD, replace the left
and right side MLG retract actuator rod ends
having P/N P3A2750 or P3A2750–1, with left
and right MLG retract actuator rod ends
having P/N P3A6460, in accordance with the
Accomplishment Instructions of Bombardier
Service Bulletin 84–32–142, dated May 4,
2016, except as required by paragraph (k) of
this AD. Accomplishing this replacement
terminates the requirements of paragraphs (g)
and (h) of this AD for that airplane.
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(n) Other FAA AD Provisions
The following provisions also apply to this
AD:
(1) Alternative Methods of Compliance
(AMOCs): The Manager, New York ACO
Branch, FAA, has the authority to approve
AMOCs for this AD, if requested using the
procedures found in 14 CFR 39.19. In
accordance with 14 CFR 39.19, send your
request to your principal inspector or local
Flight Standards District Office, as
appropriate. If sending information directly
to the manager of the certification office,
send it to ATTN: Program Manager,
Continuing Operational Safety, FAA, New
York ACO Branch, 1600 Stewart Avenue,
Suite 410, Westbury, NY 11590; telephone:
516–228–7300; fax: 516–794–5531. 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.
(2) Contacting the Manufacturer: For any
requirement in this AD to obtain corrective
actions from a manufacturer, the action must
be accomplished using a method approved
by the Manager, New York ACO Branch,
FAA; or TCCA; or Bombardier Inc.’s TCCA
DAO. If approved by the DAO, the approval
must include the DAO-authorized signature.
(o) Related Information
(1) Refer to Mandatory Continuing
Airworthiness Information (MCAI) Canadian
AD CF–2016–16R1, dated June 27, 2016, for
related information. This MCAI may be
found in the AD docket on the Internet at
https://www.regulations.gov by searching for
and locating Docket No. FAA–2017–0712.
(2) For more information about this AD,
contact Aziz Ahmed, Aerospace Engineer,
Airframe and Mechanical Systems Section,
FAA, New York ACO Branch, 1600 Stewart
Avenue, Suite 410, Westbury, NY 11590;
telephone: 516–228–7329; fax: 516–794–
5531.
(p) Material Incorporated by Reference
(1) The Director of the Federal Register
approved the incorporation by reference
(IBR) of the service information listed in this
paragraph under 5 U.S.C. 552(a) and 1 CFR
part 51.
(2) You must use this service information
as applicable to do the actions required by
this AD, unless this AD specifies otherwise.
(3) The following service information was
approved for IBR on July 20, 2016 (81 FR
43481, July 5, 2016).
(i) Bombardier Service Bulletin 84–32–142,
dated May 4, 2016.
(ii) Reserved.
(4) For service information identified in
this AD, contact Bombardier, Inc., Q-Series
Technical Help Desk, 123 Garratt Boulevard,
Toronto, Ontario M3K 1Y5, Canada;
telephone: 416–375–4000; fax: 416–375–
4539; email: thd.qseries@
aero.bombardier.com; Internet: https://
www.bombardier.com.
(5) You may view this service information
at the FAA, Transport Standards Branch,
1601 Lind Avenue SW., Renton, WA. For
information on the availability of this
material at the FAA, call 425–227–1221.
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Federal Register / Vol. 82, No. 218 / Tuesday, November 14, 2017 / Rules and Regulations
(6) You may view this service information
that is incorporated by reference at the
National Archives and Records
Administration (NARA). For information on
the availability of this material at NARA, call
202–741–6030, or go to: https://
www.archives.gov/federal-register/cfr/ibrlocations.html.
Issued in Renton, Washington, on October
30, 2017.
Jeffrey E. Duven,
Director, System Oversight Division, Aircraft
Certification Service.
[FR Doc. 2017–24166 Filed 11–13–17; 8:45 am]
BILLING CODE 4910–13–P
TENNESSEE VALLEY AUTHORITY
I. Background
18 CFR Part 1301
Privacy Act Regulations; Correction
Correction
In rule document 2017–24300,
appearing on pages 51757–51758 in the
issue of Wednesday, November 8, 2017,
make the following correction:
■ On page 51757 in the second column,
remove Amendatory instruction 2.
Dates: This correction is effective on
November 8, 2017.
[FR Doc. C1–2017–24300 Filed 11–9–17; 4:15 pm]
BILLING CODE 1301–00–D
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 866
[Docket No. FDA–2017–N–5881]
Medical Devices; Immunology and
Microbiology Devices; Classification of
the Automated Indirect
Immunofluorescence Microscope and
Software-Assisted System
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final order.
The Food and Drug
Administration (FDA or we) is
classifying the automated indirect
immunofluorescence microscope and
software-assisted system into class II
(special controls). The special controls
that apply to the device type are
identified in this order and will be part
of the codified language for the
automated indirect immunofluorescence
microscope and software-assisted
system’s classification. We are taking
this action because we have determined
that classifying the device into class II
jstallworth on DSKBBY8HB2PROD with RULES
SUMMARY:
VerDate Sep<11>2014
13:31 Nov 13, 2017
(special controls) will provide a
reasonable assurance of safety and
effectiveness of the device. We believe
this action will also enhance patients’
access to beneficial innovative devices,
in part by reducing regulatory burdens.
DATES: This order is effective November
14, 2017. The classification was
applicable on April 9, 2015.
FOR FURTHER INFORMATION CONTACT:
Steven Tjoe, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 4550, Silver Spring,
MD 20993–0002, 301–796–5866,
steven.tjoe@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
Jkt 244001
Upon request, FDA has classified the
automated indirect immunofluorescence
microscope and software-assisted
system as class II (special controls),
which we have determined will provide
a reasonable assurance of safety and
effectiveness. In addition, we believe
this action will enhance patients’ access
to beneficial innovation, in part by
reducing regulatory burdens by placing
the device into a lower device class than
the automatic class III assignment.
The automatic assignment of class III
occurs by operation of law and without
any action by FDA, regardless of the
level of risk posed by the new device.
Any device that was not in commercial
distribution before May 28, 1976, is
automatically classified as, and remains
within, class III and requires premarket
approval unless and until FDA takes an
action to classify or reclassify the device
(see 21 U.S.C. 360c(f)(1)). We refer to
these devices as ‘‘postamendments
devices’’ because they were not in
commercial distribution prior to the
date of enactment of the Medical Device
Amendments of 1976, which amended
the Federal Food, Drug, and Cosmetic
Act (the FD&C Act).
FDA may take a variety of actions in
appropriate circumstances to classify or
reclassify a device into class I or II. We
may issue an order finding a new device
to be substantially equivalent under
section 513(i) of the FD&C Act (21
U.S.C. 360c(i)) to a predicate device that
does not require premarket approval.
We determine whether a new device is
substantially equivalent to a predicate
by means of the procedures for
premarket notification under section
510(k) of the FD&C Act and part 807 (21
U.S.C. 360(k) and 21 CFR part 807,
respectively).
FDA may also classify a device
through ‘‘De Novo’’ classification, a
common name for the process
authorized under section 513(f)(2) of the
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Sfmt 4700
52647
FD&C Act. Section 207 of the Food and
Drug Administration Modernization Act
of 1997 established the first procedure
for De Novo classification (Pub. L. 105–
115). Section 607 of the Food and Drug
Administration Safety and Innovation
Act modified the De Novo application
process by adding a second procedure
(Pub. L. 112–144). A device sponsor
may utilize either procedure for De
Novo classification.
Under the first procedure, the person
submits a 510(k) for a device that has
not previously been classified. After
receiving an order from FDA classifying
the device into class III under section
513(f)(1) of the FD&C Act, the person
then requests a classification under
section 513(f)(2).
Under the second procedure, rather
than first submitting a 510(k) and then
a request for classification, if the person
determines that there is no legally
marketed device upon which to base a
determination of substantial
equivalence, that person requests a
classification under section 513(f)(2) of
the FD&C Act.
Under either procedure for De Novo
classification, FDA is required to
classify the device by written order
within 120 days. The classification will
be according to the criteria under
section 513(a)(1) of the FD&C Act.
Although the device was automatically
placed within class III, the De Novo
classification is considered to be the
initial classification of the device.
We believe this De Novo classification
will enhance patients’ access to
beneficial innovation, in part by
reducing regulatory burdens. When FDA
classifies a device into class I or II via
the De Novo process, the device can
serve as a predicate for future devices of
that type, including for 510(k)s (see 21
U.S.C. 360c(f)(2)(B)(i)). As a result, other
device sponsors do not have to submit
a De Novo request or premarket
approval application (PMA) in order to
market a substantially equivalent device
(see 21 U.S.C. 360c(i), defining
‘‘substantial equivalence’’). Instead,
sponsors can use the less-burdensome
510(k) process, when necessary, to
market their device.
II. De Novo Classification
For this device, FDA issued an order
on November 14, 2014, finding the
NOVA View® Automated Fluorescence
Microscope not substantially equivalent
to a predicate not subject to PMA. Thus,
the device remained in class III in
accordance with section 513(f)(1) of the
FD&C Act when we issued the order.
On December 11, 2014, Inova
Diagnostics, Inc. submitted a request for
De Novo classification of the NOVA
E:\FR\FM\14NOR1.SGM
14NOR1
]]>Agencies
[Federal Register Volume 82, Number 218 (Tuesday, November 14, 2017)]
[Rules and Regulations]
[Pages 52644-52647]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-24166]
=======================================================================
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DEPARTMENT OF TRANSPORTATION
Federal Aviation Administration
14 CFR Part 39
[Docket No. FAA-2017-0712; Product Identifier 2017-NM-014-AD; Amendment
39-19095; AD 2017-23-01]
RIN 2120-AA64
Airworthiness Directives; Bombardier, Inc., Airplanes
AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: We are superseding Airworthiness Directive (AD) 2016-13-14,
which applied to certain Bombardier, Inc., Model DHC-8-400 series
airplanes. AD 2016-13-14 required an inspection to determine if certain
left and right main landing gear (MLG) retract actuator rod ends were
installed, repetitive liquid penetrant inspections (LPIs) of affected
left and right MLG retract actuator rod ends, and corrective actions if
necessary. This new AD retains the actions specified in AD 2016-13-14
and also requires replacement of the left and right MLG retract
actuator rod ends. This AD was prompted by a report of a cracked MLG
retract actuator rod end. We are issuing this AD to address the unsafe
condition on these products.
DATES: This AD is effective December 19, 2017.
The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of July 20,
2016 (81 FR 43481, July 5, 2016).
ADDRESSES: For service information identified in this final rule,
contact Bombardier, Inc., Q-Series Technical Help Desk, 123 Garratt
Boulevard, Toronto, Ontario M3K 1Y5, Canada; telephone: 416-375-4000;
fax: 416-375-4539; email: thd.qseries@aero.bombardier.com; Internet:
https://www.bombardier.com. You may view this referenced service
information at the FAA, Transport Standards Branch, 1601 Lind Avenue
SW., Renton, WA. For information on the availability of this material
at the FAA, call 425-227-1221. It is also available on the Internet at
https://www.regulations.gov by searching for and locating Docket No.
FAA-2017-0712.
Examining the AD Docket
You may examine the AD docket on the Internet at https://www.regulations.gov by searching for and locating Docket No. FAA-2017-
0712; or in person at the Docket Management Facility between 9 a.m. and
5 p.m., Monday through Friday, except Federal holidays. The AD docket
contains this AD, the regulatory evaluation, any comments received, and
other information. The address for the Docket Office (telephone: 800-
647-5527) is Docket Management Facility, U.S. Department of
Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590.
FOR FURTHER INFORMATION CONTACT: Aziz Ahmed, Aerospace Engineer,
Airframe and Mechanical Systems Section, FAA, New York ACO Branch, 1600
Stewart Avenue, Suite 410, Westbury, NY 11590; telephone: 516-228-7329;
fax: 516-794-5531.
SUPPLEMENTARY INFORMATION:
Discussion
We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 to supersede AD 2016-13-14, Amendment 39-18579 (81 FR 43481,
July 5, 2016) (``AD 2016-13-14''). AD 2016-13-14 applied to certain
Bombardier, Inc., Model DHC-8-400 series airplanes. The NPRM published
in the Federal Register on July 28, 2017
[[Page 52645]]
(82 FR 35127). The NPRM was prompted by a report of a cracked MLG
retract actuator rod end. The NPRM proposed to continue to require the
actions specified in AD 2016-13-14. The NPRM also proposed to require
replacement of the left and right MLG retract actuator rod ends. We are
issuing this AD to detect and correct fatigue cracking of the left and
right MLG retract actuator rod ends, which could lead to left or right
MLG collapse.
Transport Canada Civil Aviation (TCCA), which is the aviation
authority for Canada, has issued Canadian AD CF-2016-16R1, dated June
27, 2016 (referred to after this as the Mandatory Continuing
Airworthiness Information, or ``the MCAI''), to correct an unsafe
condition for certain Bombardier, Inc. Model DHC-8-400 series
airplanes. The MCAI states:
There has been a single reported case of a cracked MLG retract
actuator rod end in service. A supplier disclosure letter and
subsequent Bombardier analysis indicate that the MLG retract
actuator rod end P/N [part number] P3A2750 and P3A2750-1 may develop
fatigue cracking. This condition, if not corrected, could lead to
left hand (LH) or right hand (RH) MLG collapse.
This [Canadian] AD mandates the inspection [to determine if
certain left and right main landing gear MLG retract actuator rod
ends are installed, repetitive LPIs of affected left and right MLG
retract actuator rod ends, and corrective actions if necessary], and
replacement of the LH and RH MLG retract actuator rod ends P/N
P3A2750 and P3A2750-1 [which is terminating action for the
repetitive LPIs].
This [Canadian] AD was revised to clarify paragraph B. and C.
[of this Canadian AD], which specifies when the Liquid Penetrant
Inspections (LPI) should begin.
Corrective actions include replacing cracked MLG retract actuator
rod ends. You may examine the MCAI in the AD docket on the Internet at
https://www.regulations.gov by searching for and locating Docket No.
FAA-2017-0712.
Comments
We gave the public the opportunity to participate in developing
this AD. We received no comments on the NPRM or on the determination of
the cost to the public.
Conclusion
We reviewed the available data and determined that air safety and
the public interest require adopting this AD as proposed except for
minor editorial changes. We have determined that these minor changes:
Are consistent with the intent that was proposed in the
NPRM for correcting the unsafe condition; and
Do not add any additional burden upon the public than was
already proposed in the NPRM.
Related Service Information Under 1 CFR Part 51
Bombardier, Inc., has issued Bombardier Service Bulletin 84-32-142,
dated May 4, 2016. This service information describes procedures for an
inspection to determine if certain left and right MLG retract actuator
rod ends are installed, repetitive LPIs of the left and right MLG
retract actuator rod ends, and replacement of left and right MLG
retract actuator rod ends. This service information is reasonably
available because the interested parties have access to it through
their normal course of business or by the means identified in the
ADDRESSES section.
Costs of Compliance
We estimate that this AD affects 52 airplanes of U.S. registry.
We estimate the following costs to comply with this AD:
The actions required by AD 2016-13-14, and retained in this AD,
take about 1 work-hour per product, at an average labor rate of $85 per
work-hour. Based on these figures, the estimated cost of the inspection
that is required by AD 2016-13-14 is $85 per product.
We also estimate that it will take about 3 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 $2,019 per
product. Based on these figures, we estimate the cost of this AD on
U.S. operators to be $118,248, or $2,274 per product.
In addition, we estimate that any necessary follow-on actions will
take about 3 work-hours and require parts costing $2,019, for a cost of
$2,274 per product. We have no way of determining the number of
aircraft that might need these actions.
According to the manufacturer, some of the costs of this AD may be
covered under warranty, thereby reducing the cost impact on affected
individuals. We do not control warranty coverage for affected
individuals. As a result, we have included all available costs in our
cost estimate.
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.
This AD is issued in accordance with authority delegated by the
Executive Director, Aircraft Certification Service, as authorized by
FAA Order 8000.51C. In accordance with that order, issuance of ADs is
normally a function of the Compliance and Airworthiness Division, but
during this transition period, the Executive Director has delegated the
authority to issue ADs applicable to transport category airplanes to
the Director of the System Oversight Division.
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 that 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);
3. Will not affect intrastate aviation in Alaska; and
4. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
List of Subjects in 14 CFR Part 39
Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.
Adoption of the Amendment
Accordingly, under the authority delegated to me by the
Administrator, the FAA amends 14 CFR part 39 as follows:
PART 39--AIRWORTHINESS DIRECTIVES
0
1. The authority citation for part 39 continues to read as follows:
[[Page 52646]]
Authority: 49 U.S.C. 106(g), 40113, 44701.
Sec. 39.13 [Amended]
0
2. The FAA amends Sec. 39.13 by removing Airworthiness Directive (AD)
2016-13-14, Amendment 39-18579 (81 FR 43481, July 5, 2016), and adding
the following new AD:
2017-23-01 Bombardier, Inc.: Amendment 39-19095; Docket No. FAA-
2017-0712; Product Identifier 2017-NM-014-AD.
(a) Effective Date
This AD is effective December 19, 2017.
(b) Affected ADs
This AD replaces AD 2016-13-14, Amendment 39-18579 (81 FR 43481,
July 5, 2016) (``AD 2016-13-14'').
(c) Applicability
This AD applies to Bombardier, Inc., Model DHC-8-400, -401 and -
402 airplanes, certificated in any category, serial numbers 4001,
and 4003 through 4325 inclusive.
(d) Subject
Air Transport Association (ATA) of America Code 32, Landing
gear.
(e) Reason
This AD was prompted by a report of a cracked main landing gear
(MLG) retract actuator rod end. We are issuing this AD to detect and
correct fatigue cracking of the left and right MLG retract actuator
rod ends, which could lead to left or right MLG collapse.
(f) Compliance
Comply with this AD within the compliance times specified,
unless already done.
(g) Retained Part Number Inspection, With No Changes
This paragraph restates the requirements of paragraph (g) of AD
2016-13-14, with no changes. Within 100 flight cycles after July 20,
2016 (the effective date of AD 2016-13-14), inspect the left and
right MLG retract actuator rod ends to determine if part number (P/
N) P3A2750 or P3A2750-1 is installed. A review of airplane
maintenance records is acceptable in lieu of this inspection if the
part number can be conclusively determined from that review.
(h) Retained Repetitive Liquid Penetrant Inspections (LPIs), With No
Changes
This paragraph restates the requirements of paragraph (h) of AD
2016-13-14, with no changes. For each left or right MLG retract
actuator rod end having P/N P3A2750 or P3A2750-1: At the applicable
time specified in paragraph (h)(1) or (h)(2) of this AD, do an LPI
to detect cracks of the MLG retract actuator rod end, in accordance
with the Accomplishment Instructions of Bombardier Service Bulletin
84-32-142, dated May 4, 2016, except as required by paragraph (k) of
this AD. Thereafter, repeat the LPI at intervals not to exceed 600
flight cycles.
(1) If the MLG retract actuator rod end has accumulated more
than 6,000 flight cycles as of July 20, 2016 (the effective date of
AD 2016-13-14): Inspect within 100 flight cycles after July 20,
2016.
(2) If the MLG retract actuator rod end has accumulated 6,000
flight cycles or fewer as of July 20, 2016 (the effective date of AD
2016-13-14): Inspect within 600 flight cycles after July 20, 2016.
(i) Retained Corrective Action, With No Changes
This paragraph restates the requirements of paragraph (i) of AD
2016-13-14, with no changes. If any crack is found during any
inspection required by paragraph (h) of this AD, before further
flight, replace the cracked MLG retract actuator rod end, P/N
P3A2750 or P3A2750-1, with a MLG retract actuator rod end, P/N
P3A6460, in accordance with the Accomplishment Instructions of
Bombardier Service Bulletin 84-32-142, dated May 4, 2016, except as
required by paragraph (k) of this AD.
(j) Retained Optional Replacement, With No Changes
This paragraph restates the optional replacement specified in
paragraph (j) of AD 2016-13-14, with no changes. Replacement of the
left and right side MLG retract actuator rod ends, P/N P3A2750 or
P3A2750-1, with left and right MLG retract actuator rod ends, P/N
P3A6460, in accordance with the Accomplishment Instructions of
Bombardier Service Bulletin 84-32-142, dated May 4, 2016, except as
required by paragraph (k) of this AD, constitutes terminating action
for the actions required by paragraphs (g) and (h) of this AD for
that airplane.
(k) Retained Exception, With No Changes
This paragraph restates the requirements of paragraph (k) of AD
2016-13-14, with no changes. If it is not possible to complete all
the instructions in Bombardier Service Bulletin 84-32-142, dated May
4, 2016, because of the configuration of the airplane: Before
further flight, repair using a method approved by the Manager, New
York ACO Branch, FAA; or Transport Canada Civil Aviation (TCCA); or
Bombardier, Inc.'s TCCA Design Approval Organization (DAO).
(l) Retained Parts Installation Prohibition, With No Changes
This paragraph restates the requirements of paragraph (l) of AD
2016-13-14, with no changes. As of July 20, 2016 (the effective date
of AD 2016-13-14), no person may install a left or right MLG retract
actuator rod end, P/N P3A2750 or P3A2750-1, on any airplane.
(m) New Requirement of This AD: Replacement
Within 1,800 flight cycles after accomplishing the initial
inspection required by paragraph (g) of this AD, replace the left
and right side MLG retract actuator rod ends having P/N P3A2750 or
P3A2750-1, with left and right MLG retract actuator rod ends having
P/N P3A6460, in accordance with the Accomplishment Instructions of
Bombardier Service Bulletin 84-32-142, dated May 4, 2016, except as
required by paragraph (k) of this AD. Accomplishing this replacement
terminates the requirements of paragraphs (g) and (h) of this AD for
that airplane.
(n) Other FAA AD Provisions
The following provisions also apply to this AD:
(1) Alternative Methods of Compliance (AMOCs): The Manager, New
York ACO Branch, FAA, has the authority to approve AMOCs for this
AD, if requested using the procedures found in 14 CFR 39.19. In
accordance with 14 CFR 39.19, send your request to your principal
inspector or local Flight Standards District Office, as appropriate.
If sending information directly to the manager of the certification
office, send it to ATTN: Program Manager, Continuing Operational
Safety, FAA, New York ACO Branch, 1600 Stewart Avenue, Suite 410,
Westbury, NY 11590; telephone: 516-228-7300; fax: 516-794-5531.
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.
(2) Contacting the Manufacturer: For any requirement in this AD
to obtain corrective actions from a manufacturer, the action must be
accomplished using a method approved by the Manager, New York ACO
Branch, FAA; or TCCA; or Bombardier Inc.'s TCCA DAO. If approved by
the DAO, the approval must include the DAO-authorized signature.
(o) Related Information
(1) Refer to Mandatory Continuing Airworthiness Information
(MCAI) Canadian AD CF-2016-16R1, dated June 27, 2016, for related
information. This MCAI may be found in the AD docket on the Internet
at https://www.regulations.gov by searching for and locating Docket
No. FAA-2017-0712.
(2) For more information about this AD, contact Aziz Ahmed,
Aerospace Engineer, Airframe and Mechanical Systems Section, FAA,
New York ACO Branch, 1600 Stewart Avenue, Suite 410, Westbury, NY
11590; telephone: 516-228-7329; fax: 516-794-5531.
(p) Material Incorporated by Reference
(1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
(2) You must use this service information as applicable to do
the actions required by this AD, unless this AD specifies otherwise.
(3) The following service information was approved for IBR on
July 20, 2016 (81 FR 43481, July 5, 2016).
(i) Bombardier Service Bulletin 84-32-142, dated May 4, 2016.
(ii) Reserved.
(4) For service information identified in this AD, contact
Bombardier, Inc., Q-Series Technical Help Desk, 123 Garratt
Boulevard, Toronto, Ontario M3K 1Y5, Canada; telephone: 416-375-
4000; fax: 416-375-4539; email: thd.qseries@aero.bombardier.com;
Internet: https://www.bombardier.com.
(5) You may view this service information at the FAA, Transport
Standards Branch, 1601 Lind Avenue SW., Renton, WA. For information
on the availability of this material at the FAA, call 425-227-1221.
[[Page 52647]]
(6) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, call 202-741-6030, or go to: https://www.archives.gov/federal-register/cfr/ibr-locations.html.
Issued in Renton, Washington, on October 30, 2017.
Jeffrey E. Duven,
Director, System Oversight Division, Aircraft Certification Service.
[FR Doc. 2017-24166 Filed 11-13-17; 8:45 am]
BILLING CODE 4910-13-P
