82_FR_52862 82 FR 52644 - Airworthiness Directives; Bombardier, Inc., Airplanes

82 FR 52644 - Airworthiness Directives; Bombardier, Inc., Airplanes

DEPARTMENT OF TRANSPORTATION
Federal Aviation Administration

Federal Register Volume 82, Issue 218 (November 14, 2017)

Page Range52644-52647
FR Document2017-24166

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.

Federal Register, Volume 82 Issue 218 (Tuesday, November 14, 2017)
[Federal Register Volume 82, Number 218 (Tuesday, November 14, 2017)]
[Rules and Regulations]
[Pages 52644-52647]
From the Federal Register Online  [www.thefederalregister.org]
[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.

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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: [email protected]; Internet: 
http://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 
http://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 http://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 
http://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 http://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: [email protected]; 
Internet: http://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: http://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



                                                52644            Federal Register / Vol. 82, No. 218 / Tuesday, November 14, 2017 / Rules and Regulations

                                                reviewing the rulemaking record for the                 (citing S.Rep.No.752, 79th Cong., 1st                 prompted by a report of a cracked MLG
                                                OLPP final rule, AMS discovered a                       Sess. 15 (1946); H.R.Rep.No.1980, 79th                retract actuator rod end. We are issuing
                                                significant, material error in the                      Cong., 2d Sess. 25 (1946)). Ordinarily,               this AD to address the unsafe condition
                                                mathematical calculation of the benefits                the thirty-day waiting period gives                   on these products.
                                                estimates. With the material error, the                 stakeholders and the public a reasonable              DATES: This AD is effective December
                                                regulatory impact analysis presented                    time to adjust behavior. Omnipoint                    19, 2017.
                                                costs and benefits in a table that could                Corp. v. F.C.C., 78 F.3d 620, 630 (D.C.                  The Director of the Federal Register
                                                be reasonably interpreted to conclude                   Cir. 1996). In this case, however, a                  approved the incorporation by reference
                                                that benefits were likely to exceed the                 thirty-day waiting period would require               of a certain publication listed in this AD
                                                costs. (82 FR 7083–82 FR 7084.)                         stakeholders to begin changing their                  as of July 20, 2016 (81 FR 43481, July
                                                However, AMS believes that the                          behavior to comply with the OLPP final                5, 2016).
                                                regulatory impact analysis’ calculation                 rule, when that rule may be delayed,                  ADDRESSES: For service information
                                                of benefits was flawed because the                      suspended, or withdrawn after the                     identified in this final rule, contact
                                                incorrect calculation was applied for the               agency has completed review of                        Bombardier, Inc., Q-Series Technical
                                                3 percent and 7 percent discount rates.                 comments in response to an notice of                  Help Desk, 123 Garratt Boulevard,
                                                Re-analysis using the correct                           proposed rulemaking that will present                 Toronto, Ontario M3K 1Y5, Canada;
                                                mathematical calculations suggests that                 the issues discussed above. It is also                telephone: 416–375–4000; fax: 416–
                                                this error was material. It is not                      contrary to the public interest to allow              375–4539; email: thd.qseries@
                                                appropriate for AMS to allow a final                    a final rule that is based on a flawed                aero.bombardier.com; Internet: http://
                                                rule to become effective based on a                     record to become effective. Thus, and                 www.bombardier.com. You may view
                                                record containing such a material error.                for the reasons stated above, waiting for             this referenced service information at
                                                AMS intends to seek public comment                      thirty days to delay the effective date of            the FAA, Transport Standards Branch,
                                                on the revised calculation of benefits.                 the OLPP final rule is not warranted by               1601 Lind Avenue SW., Renton, WA.
                                                   Due to these significant concerns                    ‘‘convenience’’ and would be                          For information on the availability of
                                                regarding statutory authority for, and                  unnecessary and contrary to the public                this material at the FAA, call 425–227–
                                                costs and benefits of, the OLPP rule,                   interest.                                             1221. It is also available on the Internet
                                                including the question whether the
                                                OLPP final rule was based on a                            Dated: November 8, 2017.                            at http://www.regulations.gov by
                                                mathematically flawed assessment of                     Sonia N. Jimenez,                                     searching for and locating Docket No.
                                                benefits, AMS is selecting Option 3:                    Acting Associate Administrator, Agricultural          FAA–2017–0712.
                                                Delay. AMS is issuing this final rule to                Marketing Service.                                    Examining the AD Docket
                                                further delay the effective date for until              [FR Doc. 2017–24675 Filed 11–9–17; 8:45 am]
                                                                                                                                                                You may examine the AD docket on
                                                May 14, 2018 to allow for AMS to issue                  BILLING CODE 3410–02–P
                                                                                                                                                              the Internet at http://
                                                another notice of proposed rulemaking
                                                                                                                                                              www.regulations.gov by searching for
                                                to receive comments on USDA statutory
                                                                                                                                                              and locating Docket No. FAA–2017–
                                                authority under the OFPA to regulate                    DEPARTMENT OF TRANSPORTATION                          0712; or in person at the Docket
                                                animal welfare; the likely costs and
                                                                                                        Federal Aviation Administration                       Management Facility between 9 a.m.
                                                benefits of the OLPP rule viewed in
                                                                                                                                                              and 5 p.m., Monday through Friday,
                                                terms of the statutory objectives of the
                                                                                                        14 CFR Part 39                                        except Federal holidays. The AD docket
                                                OPFA, as interpreted above; whether the
                                                                                                                                                              contains this AD, the regulatory
                                                OLPP rule’s requirements represent the                  [Docket No. FAA–2017–0712; Product                    evaluation, any comments received, and
                                                most innovate and least burdensome                      Identifier 2017–NM–014–AD; Amendment                  other information. The address for the
                                                way to achieve regulatory ends; and the                 39–19095; AD 2017–23–01]
                                                revised calculations and analysis of the                                                                      Docket Office (telephone: 800–647–
                                                benefits of the OLPP rule. This delay                   RIN 2120–AA64                                         5527) is Docket Management Facility,
                                                will provide additional time for AMS to                                                                       U.S. Department of Transportation,
                                                                                                        Airworthiness Directives; Bombardier,                 Docket Operations, M–30, West
                                                solicit comment on these important                      Inc., Airplanes
                                                issues and review all the comments                                                                            Building Ground Floor, Room W12–140,
                                                prior to making a final decision on the                 AGENCY:  Federal Aviation                             1200 New Jersey Avenue SE.,
                                                direction of the OLPP final rule.                       Administration (FAA), Department of                   Washington, DC 20590.
                                                   To preserve the status quo rather than               Transportation (DOT).                                 FOR FURTHER INFORMATION CONTACT: Aziz
                                                allow an expansive set of new                           ACTION: Final rule.                                   Ahmed, Aerospace Engineer, Airframe
                                                requirements to become effective only to                                                                      and Mechanical Systems Section, FAA,
                                                be delayed, suspended, or withdrawn a                   SUMMARY:   We are superseding                         New York ACO Branch, 1600 Stewart
                                                short time later and to allow AMS to                    Airworthiness Directive (AD) 2016–13–                 Avenue, Suite 410, Westbury, NY
                                                receive and consider comments on the                    14, which applied to certain                          11590; telephone: 516–228–7329; fax:
                                                issues discussed above, this final rule                 Bombardier, Inc., Model DHC–8–400                     516–794–5531.
                                                action is effective upon publication                    series airplanes. AD 2016–13–14                       SUPPLEMENTARY INFORMATION:
                                                because AMS believes that the 30-day                    required an inspection to determine if
                                                delay is impracticable, unnecessary, and                certain left and right main landing gear              Discussion
                                                contrary to the public interest. When                   (MLG) retract actuator rod ends were                    We issued a notice of proposed
                                                agencies establish good cause for an                    installed, repetitive liquid penetrant                rulemaking (NPRM) to amend 14 CFR
jstallworth on DSKBBY8HB2PROD with RULES




                                                immediate effective date, Congress                      inspections (LPIs) of affected left and               part 39 to supersede AD 2016–13–14,
                                                intended that, combined with                            right MLG retract actuator rod ends, and              Amendment 39–18579 (81 FR 43481,
                                                unavoidable time limitations, ‘‘the                     corrective actions if necessary. This new             July 5, 2016) (‘‘AD 2016–13–14’’). AD
                                                primary consideration was to be the                     AD retains the actions specified in AD                2016–13–14 applied to certain
                                                ‘convenience or necessity of the people                 2016–13–14 and also requires                          Bombardier, Inc., Model DHC–8–400
                                                affected.’ ’’ United States v. Gavrilovic,              replacement of the left and right MLG                 series airplanes. The NPRM published
                                                551 F.2d 1099, 1104 (8th Cir. 1977)                     retract actuator rod ends. This AD was                in the Federal Register on July 28, 2017


                                           VerDate Sep<11>2014   13:31 Nov 13, 2017   Jkt 244001   PO 00000   Frm 00002   Fmt 4700   Sfmt 4700   E:\FR\FM\14NOR1.SGM   14NOR1


                                                                 Federal Register / Vol. 82, No. 218 / Tuesday, November 14, 2017 / Rules and Regulations                                         52645

                                                (82 FR 35127). The NPRM was                               • Do not add any additional burden                     We are issuing this rulemaking under
                                                prompted by a report of a cracked MLG                   upon the public than was already                      the authority described in ‘‘Subtitle VII,
                                                retract actuator rod end. The NPRM                      proposed in the NPRM.                                 Part A, Subpart III, Section 44701:
                                                proposed to continue to require the                                                                           General requirements.’’ Under that
                                                                                                        Related Service Information Under
                                                actions specified in AD 2016–13–14.                                                                           section, Congress charges the FAA with
                                                                                                        1 CFR Part 51                                         promoting safe flight of civil aircraft in
                                                The NPRM also proposed to require
                                                replacement of the left and right MLG                     Bombardier, Inc., has issued                        air commerce by prescribing regulations
                                                retract actuator rod ends. We are issuing               Bombardier Service Bulletin 84–32–142,                for practices, methods, and procedures
                                                this AD to detect and correct fatigue                   dated May 4, 2016. This service                       the Administrator finds necessary for
                                                cracking of the left and right MLG                      information describes procedures for an               safety in air commerce. This regulation
                                                retract actuator rod ends, which could                  inspection to determine if certain left               is within the scope of that authority
                                                lead to left or right MLG collapse.                     and right MLG retract actuator rod ends               because it addresses an unsafe condition
                                                   Transport Canada Civil Aviation                      are installed, repetitive LPIs of the left            that is likely to exist or develop on
                                                (TCCA), which is the aviation authority                 and right MLG retract actuator rod ends,              products identified in this rulemaking
                                                for Canada, has issued Canadian AD                      and replacement of left and right MLG                 action.
                                                CF–2016–16R1, dated June 27, 2016                       retract actuator rod ends. This service                  This AD is issued in accordance with
                                                (referred to after this as the Mandatory                information is reasonably available                   authority delegated by the Executive
                                                Continuing Airworthiness Information,                   because the interested parties have                   Director, Aircraft Certification Service,
                                                or ‘‘the MCAI’’), to correct an unsafe                  access to it through their normal course              as authorized by FAA Order 8000.51C.
                                                condition for certain Bombardier, Inc.                  of business or by the means identified                In accordance with that order, issuance
                                                Model DHC–8–400 series airplanes. The                   in the ADDRESSES section.                             of ADs is normally a function of the
                                                MCAI states:                                                                                                  Compliance and Airworthiness
                                                                                                        Costs of Compliance                                   Division, but during this transition
                                                   There has been a single reported case of a
                                                                                                           We estimate that this AD affects 52                period, the Executive Director has
                                                cracked MLG retract actuator rod end in
                                                service. A supplier disclosure letter and               airplanes of U.S. registry.                           delegated the authority to issue ADs
                                                subsequent Bombardier analysis indicate that               We estimate the following costs to                 applicable to transport category
                                                the MLG retract actuator rod end P/N [part              comply with this AD:                                  airplanes to the Director of the System
                                                number] P3A2750 and P3A2750–1 may                          The actions required by AD 2016–13–                Oversight Division.
                                                develop fatigue cracking. This condition, if            14, and retained in this AD, take about
                                                not corrected, could lead to left hand (LH) or
                                                                                                                                                              Regulatory Findings
                                                right hand (RH) MLG collapse.
                                                                                                        1 work-hour per product, at an average                  We determined that this AD will not
                                                   This [Canadian] AD mandates the                      labor rate of $85 per work-hour. Based                have federalism implications under
                                                inspection [to determine if certain left and            on these figures, the estimated cost of               Executive Order 13132. This AD will
                                                right main landing gear MLG retract actuator            the inspection that is required by AD                 not have a substantial direct effect on
                                                rod ends are installed, repetitive LPIs of              2016–13–14 is $85 per product.                        the States, on the relationship between
                                                affected left and right MLG retract actuator               We also estimate that it will take
                                                rod ends, and corrective actions if necessary],                                                               the national government and the States,
                                                                                                        about 3 work-hours per product to                     or on the distribution of power and
                                                and replacement of the LH and RH MLG                    comply with the basic requirements of
                                                retract actuator rod ends P/N P3A2750 and                                                                     responsibilities among the various
                                                                                                        this AD. The average labor rate is $85                levels of government.
                                                P3A2750–1 [which is terminating action for
                                                the repetitive LPIs].                                   per work-hour. Required parts will cost                 For the reasons discussed above, I
                                                   This [Canadian] AD was revised to clarify            about $2,019 per product. Based on                    certify that this AD:
                                                paragraph B. and C. [of this Canadian AD],              these figures, we estimate the cost of                  1. Is not a ‘‘significant regulatory
                                                which specifies when the Liquid Penetrant               this AD on U.S. operators to be                       action’’ under Executive Order 12866;
                                                Inspections (LPI) should begin.                         $118,248, or $2,274 per product.                        2. Is not a ‘‘significant rule’’ under the
                                                  Corrective actions include replacing                     In addition, we estimate that any                  DOT Regulatory Policies and Procedures
                                                cracked MLG retract actuator rod ends.                  necessary follow-on actions will take                 (44 FR 11034, February 26, 1979);
                                                You may examine the MCAI in the AD                      about 3 work-hours and require parts                    3. Will not affect intrastate aviation in
                                                docket on the Internet at http://                       costing $2,019, for a cost of $2,274 per              Alaska; and
                                                www.regulations.gov by searching for                    product. We have no way of                              4. Will not have a significant
                                                and locating Docket No. FAA–2017–                       determining the number of aircraft that               economic impact, positive or negative,
                                                0712.                                                   might need these actions.                             on a substantial number of small entities
                                                                                                           According to the manufacturer, some                under the criteria of the Regulatory
                                                Comments                                                of the costs of this AD may be covered                Flexibility Act.
                                                  We gave the public the opportunity to                 under warranty, thereby reducing the                  List of Subjects in 14 CFR Part 39
                                                participate in developing this AD. We                   cost impact on affected individuals. We
                                                received no comments on the NPRM or                     do not control warranty coverage for                    Air transportation, Aircraft, Aviation
                                                on the determination of the cost to the                 affected individuals. As a result, we                 safety, Incorporation by reference,
                                                public.                                                 have included all available costs in our              Safety.
                                                                                                        cost estimate.                                        Adoption of the Amendment
                                                Conclusion
                                                                                                        Authority for This Rulemaking                           Accordingly, under the authority
                                                  We reviewed the available data and
                                                                                                                                                              delegated to me by the Administrator,
                                                determined that air safety and the                        Title 49 of the United States Code
                                                                                                                                                              the FAA amends 14 CFR part 39 as
jstallworth on DSKBBY8HB2PROD with RULES




                                                public interest require adopting this AD                specifies the FAA’s authority to issue
                                                                                                                                                              follows:
                                                as proposed except for minor editorial                  rules on aviation safety. Subtitle I,
                                                changes. We have determined that these                  section 106, describes the authority of               PART 39—AIRWORTHINESS
                                                minor changes:                                          the FAA Administrator. ‘‘Subtitle VII:                DIRECTIVES
                                                  • Are consistent with the intent that                 Aviation Programs,’’ describes in more
                                                was proposed in the NPRM for                            detail the scope of the Agency’s                      ■ 1. The authority citation for part 39
                                                correcting the unsafe condition; and                    authority.                                            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.          2016–13–14): Inspect within 100 flight cycles         (n) Other FAA AD Provisions
                                                                                                        after July 20, 2016.                                     The following provisions also apply to this
                                                § 39.13   [Amended]                                        (2) If the MLG retract actuator rod end has        AD:
                                                ■ 2. The FAA amends § 39.13 by                          accumulated 6,000 flight cycles or fewer as              (1) Alternative Methods of Compliance
                                                removing Airworthiness Directive (AD)                   of July 20, 2016 (the effective date of AD            (AMOCs): The Manager, New York ACO
                                                                                                        2016–13–14): Inspect within 600 flight cycles         Branch, FAA, has the authority to approve
                                                2016–13–14, Amendment 39–18579 (81                      after July 20, 2016.
                                                FR 43481, July 5, 2016), and adding the                                                                       AMOCs for this AD, if requested using the
                                                                                                        (i) Retained Corrective Action, With No               procedures found in 14 CFR 39.19. In
                                                following new AD:
                                                                                                        Changes                                               accordance with 14 CFR 39.19, send your
                                                2017–23–01 Bombardier, Inc.: Amendment                                                                        request to your principal inspector or local
                                                    39–19095; Docket No. FAA–2017–0712;                    This paragraph restates the requirements of        Flight Standards District Office, as
                                                    Product Identifier 2017–NM–014–AD.                  paragraph (i) of AD 2016–13–14, with no               appropriate. If sending information directly
                                                                                                        changes. If any crack is found during any             to the manager of the certification office,
                                                (a) Effective Date                                      inspection required by paragraph (h) of this          send it to ATTN: Program Manager,
                                                  This AD is effective December 19, 2017.               AD, before further flight, replace the cracked        Continuing Operational Safety, FAA, New
                                                                                                        MLG retract actuator rod end, P/N P3A2750             York ACO Branch, 1600 Stewart Avenue,
                                                (b) Affected ADs                                        or P3A2750–1, with a MLG retract actuator             Suite 410, Westbury, NY 11590; telephone:
                                                  This AD replaces AD 2016–13–14,                       rod end, P/N P3A6460, in accordance with              516–228–7300; fax: 516–794–5531. Before
                                                Amendment 39–18579 (81 FR 43481, July 5,                the Accomplishment Instructions of                    using any approved AMOC, notify your
                                                2016) (‘‘AD 2016–13–14’’).                              Bombardier Service Bulletin 84–32–142,                appropriate principal inspector, or lacking a
                                                                                                        dated May 4, 2016, except as required by              principal inspector, the manager of the local
                                                (c) Applicability                                       paragraph (k) of this AD.                             flight standards district office/certificate
                                                   This AD applies to Bombardier, Inc.,                                                                       holding district office.
                                                                                                        (j) Retained Optional Replacement, With No
                                                Model DHC–8–400, –401 and –402 airplanes,                                                                        (2) Contacting the Manufacturer: For any
                                                certificated in any category, serial numbers            Changes
                                                                                                                                                              requirement in this AD to obtain corrective
                                                4001, and 4003 through 4325 inclusive.                     This paragraph restates the optional
                                                                                                                                                              actions from a manufacturer, the action must
                                                                                                        replacement specified in paragraph (j) of AD
                                                (d) Subject                                                                                                   be accomplished using a method approved
                                                                                                        2016–13–14, with no changes. Replacement
                                                                                                                                                              by the Manager, New York ACO Branch,
                                                  Air Transport Association (ATA) of                    of the left and right side MLG retract actuator
                                                                                                                                                              FAA; or TCCA; or Bombardier Inc.’s TCCA
                                                America Code 32, Landing gear.                          rod ends, P/N P3A2750 or P3A2750–1, with
                                                                                                                                                              DAO. If approved by the DAO, the approval
                                                                                                        left and right MLG retract actuator rod ends,
                                                (e) Reason                                                                                                    must include the DAO-authorized signature.
                                                                                                        P/N P3A6460, in accordance with the
                                                   This AD was prompted by a report of a                Accomplishment Instructions of Bombardier             (o) Related Information
                                                cracked main landing gear (MLG) retract                 Service Bulletin 84–32–142, dated May 4,                 (1) Refer to Mandatory Continuing
                                                actuator rod end. We are issuing this AD to             2016, except as required by paragraph (k) of          Airworthiness Information (MCAI) Canadian
                                                detect and correct fatigue cracking of the left         this AD, constitutes terminating action for           AD CF–2016–16R1, dated June 27, 2016, for
                                                and right MLG retract actuator rod ends,                the actions required by paragraphs (g) and (h)        related information. This MCAI may be
                                                which could lead to left or right MLG                   of this AD for that airplane.
                                                                                                                                                              found in the AD docket on the Internet at
                                                collapse.
                                                                                                        (k) Retained Exception, With No Changes               http://www.regulations.gov by searching for
                                                (f) Compliance                                            This paragraph restates the requirements of         and locating Docket No. FAA–2017–0712.
                                                   Comply with this AD within the                       paragraph (k) of AD 2016–13–14, with no                  (2) For more information about this AD,
                                                compliance times specified, unless already              changes. If it is not possible to complete all        contact Aziz Ahmed, Aerospace Engineer,
                                                done.                                                   the instructions in Bombardier Service                Airframe and Mechanical Systems Section,
                                                                                                        Bulletin 84–32–142, dated May 4, 2016,                FAA, New York ACO Branch, 1600 Stewart
                                                (g) Retained Part Number Inspection, With                                                                     Avenue, Suite 410, Westbury, NY 11590;
                                                                                                        because of the configuration of the airplane:
                                                No Changes                                                                                                    telephone: 516–228–7329; fax: 516–794–
                                                                                                        Before further flight, repair using a method
                                                   This paragraph restates the requirements of          approved by the Manager, New York ACO                 5531.
                                                paragraph (g) of AD 2016–13–14, with no                 Branch, FAA; or Transport Canada Civil                (p) Material Incorporated by Reference
                                                changes. Within 100 flight cycles after July            Aviation (TCCA); or Bombardier, Inc.’s TCCA
                                                20, 2016 (the effective date of AD 2016–13–             Design Approval Organization (DAO).                      (1) The Director of the Federal Register
                                                14), inspect the left and right MLG retract                                                                   approved the incorporation by reference
                                                actuator rod ends to determine if part number           (l) Retained Parts Installation Prohibition,          (IBR) of the service information listed in this
                                                (P/N) P3A2750 or P3A2750–1 is installed. A              With No Changes                                       paragraph under 5 U.S.C. 552(a) and 1 CFR
                                                review of airplane maintenance records is                  This paragraph restates the requirements of        part 51.
                                                acceptable in lieu of this inspection if the            paragraph (l) of AD 2016–13–14, with no                  (2) You must use this service information
                                                part number can be conclusively determined              changes. As of July 20, 2016 (the effective           as applicable to do the actions required by
                                                from that review.                                       date of AD 2016–13–14), no person may                 this AD, unless this AD specifies otherwise.
                                                                                                        install a left or right MLG retract actuator rod         (3) The following service information was
                                                (h) Retained Repetitive Liquid Penetrant                                                                      approved for IBR on July 20, 2016 (81 FR
                                                                                                        end, P/N P3A2750 or P3A2750–1, on any
                                                Inspections (LPIs), With No Changes                                                                           43481, July 5, 2016).
                                                                                                        airplane.
                                                  This paragraph restates the requirements of                                                                    (i) Bombardier Service Bulletin 84–32–142,
                                                paragraph (h) of AD 2016–13–14, with no                 (m) New Requirement of This AD:                       dated May 4, 2016.
                                                changes. For each left or right MLG retract             Replacement                                              (ii) Reserved.
                                                actuator rod end having P/N P3A2750 or                    Within 1,800 flight cycles after                       (4) For service information identified in
                                                P3A2750–1: At the applicable time specified             accomplishing the initial inspection required         this AD, contact Bombardier, Inc., Q-Series
                                                in paragraph (h)(1) or (h)(2) of this AD, do            by paragraph (g) of this AD, replace the left         Technical Help Desk, 123 Garratt Boulevard,
                                                an LPI to detect cracks of the MLG retract              and right side MLG retract actuator rod ends          Toronto, Ontario M3K 1Y5, Canada;
                                                actuator rod end, in accordance with the                having P/N P3A2750 or P3A2750–1, with left            telephone: 416–375–4000; fax: 416–375–
jstallworth on DSKBBY8HB2PROD with RULES




                                                Accomplishment Instructions of Bombardier               and right MLG retract actuator rod ends               4539; email: thd.qseries@
                                                Service Bulletin 84–32–142, dated May 4,                having P/N P3A6460, in accordance with the            aero.bombardier.com; Internet: http://
                                                2016, except as required by paragraph (k) of            Accomplishment Instructions of Bombardier             www.bombardier.com.
                                                this AD. Thereafter, repeat the LPI at                  Service Bulletin 84–32–142, dated May 4,                 (5) You may view this service information
                                                intervals not to exceed 600 flight cycles.              2016, except as required by paragraph (k) of          at the FAA, Transport Standards Branch,
                                                  (1) If the MLG retract actuator rod end has           this AD. Accomplishing this replacement               1601 Lind Avenue SW., Renton, WA. For
                                                accumulated more than 6,000 flight cycles as            terminates the requirements of paragraphs (g)         information on the availability of this
                                                of July 20, 2016 (the effective date of AD              and (h) of this AD for that airplane.                 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                                         52647

                                                  (6) You may view this service information             (special controls) will provide a                     FD&C Act. Section 207 of the Food and
                                                that is incorporated by reference at the                reasonable assurance of safety and                    Drug Administration Modernization Act
                                                National Archives and Records                           effectiveness of the device. We believe               of 1997 established the first procedure
                                                Administration (NARA). For information on               this action will also enhance patients’               for De Novo classification (Pub. L. 105–
                                                the availability of this material at NARA, call
                                                202–741–6030, or go to: http://
                                                                                                        access to beneficial innovative devices,              115). Section 607 of the Food and Drug
                                                www.archives.gov/federal-register/cfr/ibr-              in part by reducing regulatory burdens.               Administration Safety and Innovation
                                                locations.html.                                         DATES: This order is effective November               Act modified the De Novo application
                                                                                                        14, 2017. The classification was                      process by adding a second procedure
                                                  Issued in Renton, Washington, on October
                                                                                                        applicable on April 9, 2015.                          (Pub. L. 112–144). A device sponsor
                                                30, 2017.
                                                                                                        FOR FURTHER INFORMATION CONTACT:
                                                                                                                                                              may utilize either procedure for De
                                                Jeffrey E. Duven,                                                                                             Novo classification.
                                                Director, System Oversight Division, Aircraft           Steven Tjoe, Center for Devices and
                                                                                                                                                                 Under the first procedure, the person
                                                Certification Service.                                  Radiological Health, Food and Drug
                                                                                                                                                              submits a 510(k) for a device that has
                                                [FR Doc. 2017–24166 Filed 11–13–17; 8:45 am]            Administration, 10903 New Hampshire
                                                                                                                                                              not previously been classified. After
                                                                                                        Ave., Bldg. 66, Rm. 4550, Silver Spring,
                                                BILLING CODE 4910–13–P                                                                                        receiving an order from FDA classifying
                                                                                                        MD 20993–0002, 301–796–5866,
                                                                                                                                                              the device into class III under section
                                                                                                        steven.tjoe@fda.hhs.gov.
                                                                                                                                                              513(f)(1) of the FD&C Act, the person
                                                                                                        SUPPLEMENTARY INFORMATION:                            then requests a classification under
                                                TENNESSEE VALLEY AUTHORITY
                                                                                                        I. Background                                         section 513(f)(2).
                                                18 CFR Part 1301                                                                                                 Under the second procedure, rather
                                                                                                           Upon request, FDA has classified the               than first submitting a 510(k) and then
                                                Privacy Act Regulations; Correction                     automated indirect immunofluorescence                 a request for classification, if the person
                                                                                                        microscope and software-assisted                      determines that there is no legally
                                                Correction                                              system as class II (special controls),                marketed device upon which to base a
                                                   In rule document 2017–24300,                         which we have determined will provide                 determination of substantial
                                                appearing on pages 51757–51758 in the                   a reasonable assurance of safety and                  equivalence, that person requests a
                                                issue of Wednesday, November 8, 2017,                   effectiveness. In addition, we believe                classification under section 513(f)(2) of
                                                make the following correction:                          this action will enhance patients’ access             the FD&C Act.
                                                ■ On page 51757 in the second column,
                                                                                                        to beneficial innovation, in part by                     Under either procedure for De Novo
                                                remove Amendatory instruction 2.                        reducing regulatory burdens by placing                classification, FDA is required to
                                                                                                        the device into a lower device class than             classify the device by written order
                                                   Dates: This correction is effective on               the automatic class III assignment.
                                                November 8, 2017.                                                                                             within 120 days. The classification will
                                                                                                           The automatic assignment of class III              be according to the criteria under
                                                [FR Doc. C1–2017–24300 Filed 11–9–17; 4:15 pm]          occurs by operation of law and without                section 513(a)(1) of the FD&C Act.
                                                BILLING CODE 1301–00–D                                  any action by FDA, regardless of the                  Although the device was automatically
                                                                                                        level of risk posed by the new device.                placed within class III, the De Novo
                                                                                                        Any device that was not in commercial                 classification is considered to be the
                                                DEPARTMENT OF HEALTH AND                                distribution before May 28, 1976, is                  initial classification of the device.
                                                HUMAN SERVICES                                          automatically classified as, and remains                 We believe this De Novo classification
                                                                                                        within, class III and requires premarket              will enhance patients’ access to
                                                Food and Drug Administration                            approval unless and until FDA takes an                beneficial innovation, in part by
                                                                                                        action to classify or reclassify the device           reducing regulatory burdens. When FDA
                                                21 CFR Part 866                                         (see 21 U.S.C. 360c(f)(1)). We refer to               classifies a device into class I or II via
                                                                                                        these devices as ‘‘postamendments                     the De Novo process, the device can
                                                [Docket No. FDA–2017–N–5881]
                                                                                                        devices’’ because they were not in                    serve as a predicate for future devices of
                                                Medical Devices; Immunology and                         commercial distribution prior to the                  that type, including for 510(k)s (see 21
                                                Microbiology Devices; Classification of                 date of enactment of the Medical Device               U.S.C. 360c(f)(2)(B)(i)). As a result, other
                                                the Automated Indirect                                  Amendments of 1976, which amended                     device sponsors do not have to submit
                                                Immunofluorescence Microscope and                       the Federal Food, Drug, and Cosmetic                  a De Novo request or premarket
                                                Software-Assisted System                                Act (the FD&C Act).                                   approval application (PMA) in order to
                                                                                                           FDA may take a variety of actions in               market a substantially equivalent device
                                                AGENCY:    Food and Drug Administration,                appropriate circumstances to classify or              (see 21 U.S.C. 360c(i), defining
                                                HHS.                                                    reclassify a device into class I or II. We            ‘‘substantial equivalence’’). Instead,
                                                ACTION:   Final order.                                  may issue an order finding a new device               sponsors can use the less-burdensome
                                                                                                        to be substantially equivalent under                  510(k) process, when necessary, to
                                                SUMMARY:   The Food and Drug                            section 513(i) of the FD&C Act (21                    market their device.
                                                Administration (FDA or we) is                           U.S.C. 360c(i)) to a predicate device that
                                                classifying the automated indirect                      does not require premarket approval.                  II. De Novo Classification
                                                immunofluorescence microscope and                       We determine whether a new device is                     For this device, FDA issued an order
                                                software-assisted system into class II                  substantially equivalent to a predicate               on November 14, 2014, finding the
                                                (special controls). The special controls                by means of the procedures for                        NOVA View® Automated Fluorescence
                                                that apply to the device type are                       premarket notification under section                  Microscope not substantially equivalent
jstallworth on DSKBBY8HB2PROD with RULES




                                                identified in this order and will be part               510(k) of the FD&C Act and part 807 (21               to a predicate not subject to PMA. Thus,
                                                of the codified language for the                        U.S.C. 360(k) and 21 CFR part 807,                    the device remained in class III in
                                                automated indirect immunofluorescence                   respectively).                                        accordance with section 513(f)(1) of the
                                                microscope and software-assisted                           FDA may also classify a device                     FD&C Act when we issued the order.
                                                system’s classification. We are taking                  through ‘‘De Novo’’ classification, a                    On December 11, 2014, Inova
                                                this action because we have determined                  common name for the process                           Diagnostics, Inc. submitted a request for
                                                that classifying the device into class II               authorized under section 513(f)(2) of the             De Novo classification of the NOVA


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Document Created: 2018-10-25 10:33:10
Document Modified: 2018-10-25 10:33:10
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionRules and Regulations
ActionFinal rule.
DatesThis AD is effective December 19, 2017.
ContactAziz 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.
FR Citation82 FR 52644 
RIN Number2120-AA64
CFR AssociatedAir Transportation; Aircraft; Aviation Safety; Incorporation by Reference and Safety

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