83 FR 6791 - Airworthiness Directives; Airbus Airplanes

DEPARTMENT OF TRANSPORTATION
Federal Aviation Administration

Federal Register Volume 83, Issue 32 (February 15, 2018)

Page Range		6791-6793
FR Document		2018-03185

We are adopting a new airworthiness directive (AD) for all Airbus Model A320-271N, A321-271N, and A321-272N airplanes. This AD requires de-pairing certain International Aero Engines (IAE) engines in order to continue to operate affected airplanes and discontinuing extended operations (ETOPS) for airplanes with at least one affected engine. This AD was prompted by reports of two engine in-flight shutdowns (IFSDs) and two rejected takeoffs. We are issuing this AD to address the unsafe condition on these products.

Federal Register, Volume 83 Issue 32 (Thursday, February 15, 2018)

[Federal Register Volume 83, Number 32 (Thursday, February 15, 2018)]
[Rules and Regulations]
[Pages 6791-6793]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-03185]



========================================================================
Rules and Regulations
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains regulatory documents 
having general applicability and legal effect, most of which are keyed 
to and codified in the Code of Federal Regulations, which is published 
under 50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by the Superintendent of Documents. 

========================================================================


Federal Register / Vol. 83, No. 32 / Thursday, February 15, 2018 / 
Rules and Regulations

[[Page 6791]]



DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2018-0109; Product Identifier 2018-NM-022-AD; Amendment 
39-19196; AD 2018-04-01]
RIN 2120-AA64


Airworthiness Directives; Airbus Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule; request for comments.

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

SUMMARY: We are adopting a new airworthiness directive (AD) for all 
Airbus Model A320-271N, A321-271N, and A321-272N airplanes. This AD 
requires de-pairing certain International Aero Engines (IAE) engines in 
order to continue to operate affected airplanes and discontinuing 
extended operations (ETOPS) for airplanes with at least one affected 
engine. This AD was prompted by reports of two engine in-flight 
shutdowns (IFSDs) and two rejected takeoffs. We are issuing this AD to 
address the unsafe condition on these products.

DATES: This AD becomes effective February 15, 2018.
    We must receive comments on this AD by April 2, 2018.

ADDRESSES: You may send comments, using the procedures found in 14 CFR 
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax: 202-493-2251.
     Mail: U.S. Department of Transportation, Docket 
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New 
Jersey Avenue SE, Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket 
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New 
Jersey Avenue SE, Washington, DC, between 9 a.m. and 5 p.m., Monday 
through Friday, except Federal holidays.

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-2018-
0109; or in person at the Docket Operations office between 9 a.m. and 5 
p.m., Monday through Friday, except Federal holidays. The AD docket 
contains this AD, the regulatory evaluation, any comments received, and 
other information. The street address for the Docket Operations office 
(telephone 800-647-5527) is in the ADDRESSES section. Comments will be 
available in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Sanjay Ralhan, Aerospace Engineer, 
International Section, Transport Standards Branch, FAA, 1601 Lind 
Avenue SW, Renton, WA 98057-3356; telephone: 425-227-1405; fax: 425- 
227-1149.

SUPPLEMENTARY INFORMATION:

Discussion

    The European Aviation Safety Agency (EASA), which is the Technical 
Agent for the Member States of the European Union, has issued EASA 
Emergency Airworthiness Directive 2018-0041-E, dated February 9, 2018 
(referred to after this as the Mandatory Continuing Airworthiness 
Information, or ``the MCAI''), to correct an unsafe condition for 
Airbus Model A320-271N, A321-271N, and A321-272N airplanes, with 
certain IAE engines. The MCAI states:

    Several occurrences of engine in-flight shut-down (IFSD) and 
Rejected Take-Off (RTO) have been reported on certain Airbus A320neo 
family aeroplanes. While investigation is ongoing to determine the 
root cause, preliminary findings indicate that the affected engines, 
which have high pressure compressor aft hub modification embodied 
from ESN P770450, are more susceptible to IFSD.
    This condition, if not corrected, could lead to dual engine 
IFSD.
    To address this potentially unsafe condition, Airbus issued 
Alert Operators Transmission (AOT) A71N014-18, providing 
instructions to de-pair the affected engines and discontinue 
Extended range Two-engine aeroplanes Operations (ETOPS) for aircraft 
fitted with affected engines.
    For the reasons described above, this [EASA] AD requires 
implementation of operational restrictions.
    This [EASA] AD is considered to be an interim action and further 
AD action may follow.

    The unsafe condition is a high-pressure compressor (HPC) rear hub 
knife edge seal fracture, which could lead to a sudden increase in high 
rotor vibration and stall in certain IAE PW1100G-JM engines, and 
consequent IFSDs and rejected takeoffs. You may examine the MCAI on the 
internet at http://www.regulations.gov by searching for and locating 
Docket No. FAA-2018-0109.

FAA's Determination and Requirements of This AD

    This product has been approved by the aviation authority of another 
country, and is approved for operation in the United States. Pursuant 
to our bilateral agreement with the State of Design Authority, we have 
been notified of the unsafe condition described in the MCAI. We are 
issuing this AD because we evaluated all pertinent information and 
determined the unsafe condition exists and is likely to exist or 
develop on other products of the same type design.

FAA's Determination of the Effective Date

    An unsafe condition exists that requires the immediate adoption of 
this AD without providing an opportunity for public comments prior to 
adoption. The FAA has found that the risk to the flying public 
justifies waiving notice and comment prior to adoption of this rule 
because of an unacceptable rate of IFSDs and rejected takeoffs on 
affected airplanes. Therefore, we determined that notice and 
opportunity for public comment before issuing this AD are 
impracticable. In addition, for the reasons stated above we find that 
good cause exists for making this amendment effective in less than 30 
days.

Comments Invited

    This AD is a final rule that involves requirements affecting flight 
safety, and we did not precede it by notice and opportunity for public 
comment. We invite you to send any written relevant data, views, or 
arguments about this AD. Send your comments to an address listed under 
the ADDRESSES section. Include ``Docket No. FAA-2018-0109;

[[Page 6792]]

Product Identifier 2018-NM-022-AD'' at the beginning of your comments. 
We specifically invite comments on the overall regulatory, economic, 
environmental, and energy aspects of this AD. We will consider all 
comments received by the closing date and may amend this AD based on 
those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We 
will also post a report summarizing each substantive verbal contact we 
receive about this AD.

Costs of Compliance

    We estimate that this AD affects 8 airplanes of U.S. registry.
    We recognize that this AD may impose certain operational costs. 
However, we cannot calculate those costs because we do not know how 
often the conditions occur. Continued operational safety makes these 
costs necessary because of the severity of the unsafe condition.
    If an operator chooses to replace an affected engine, we estimate 
it would take 8 work-hours, at $85 per hour, or $680 per product.

Authority for This Rulemaking

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

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


Sec.  39.13  [Amended]

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

2018-04-01 Airbus: Amendment 39-19196; Docket No. FAA-2018-0109; 
Product Identifier 2018-NM-022-AD.

(a) Effective Date

    This AD becomes effective February 15, 2018.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Airbus Model A320-271N, A321-271N, and A321-
272N airplanes, certificated in any category, all manufacturer 
serial numbers.

(d) Subject

    Air Transport Association (ATA) of America Code 72, Engine.

(e) Reason

    This AD was prompted by reports of two engine in-flight 
shutdowns (IFSDs) and two rejected takeoffs. We are issuing this AD 
to address a high-pressure compressor (HPC) rear hub knife edge seal 
fracture, which could lead to a sudden increase in high rotor 
vibration and stall in certain PW1100G-JM engines, and consequent 
IFSDs or rejected takeoffs.

(f) Compliance

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

(g) Affected Engines

    For the purpose of this AD, affected engines are International 
Aero Engines Model PW1127G-JM, PW1127GA-JM, PW1130G-JM, PW1133G-JM, 
and PW1133GA-JM engines, having engine serial numbers P770450 and 
subsequent.

(h) Operational Restrictions

    (1) No later than 3 flight cycles after the effective date of 
this AD, do not operate an airplane having two affected engines 
installed.
    (2) For an airplane having at least one affected engine 
installed: No later than 1 flight cycle after the effective date of 
this AD, extended operations (ETOPS) are not allowed.

(i) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager, 
International Section, Transport Standards 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 International Section, send it to the attention of 
the person identified in paragraph (j)(2) of this AD. Information 
may be emailed to [email protected]. 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, International 
Section, Transport Standards Branch, FAA; or the European Aviation 
Safety Agency (EASA); or Airbus's EASA Design Organization Approval 
(DOA). If approved by the DOA, the approval must include the DOA-
authorized signature.

(j) Related Information

    (1) Refer to Mandatory Continuing Airworthiness Information 
(MCAI) EASA emergency Airworthiness Directive 2018-0041-E, dated 
February 9, 2018, for related information. You may examine the MCAI 
on the internet at http://www.regulations.gov by

[[Page 6793]]

searching for and locating Docket No. FAA-2018-0109.
    (2) For more information about this AD, contact Sanjay Ralhan, 
Aerospace Engineer, International Section, Transport Standards 
Branch, FAA, 1601 Lind Avenue SW, Renton, WA 98057-3356; telephone: 
425-227-1405; fax: 425-227-1149.

(k) Material Incorporated by Reference

    None.

    Issued in Renton, Washington, on February 12, 2018.
Michael Kaszycki,
Acting Director, System Oversight Division, Aircraft Certification 
Service.
[FR Doc. 2018-03185 Filed 2-14-18; 8:45 am]
BILLING CODE 4910-13-P

6791

Rules and Regulations Federal Register
Vol. 83, No. 32

Thursday, February 15, 2018

This section of the FEDERAL REGISTER 30, West Building Ground Floor, Room For the reasons described above, this
contains regulatory documents having general W12–140, 1200 New Jersey Avenue SE, [EASA] AD requires implementation of
applicability and legal effect, most of which Washington, DC, between 9 a.m. and 5 operational restrictions.
are keyed to and codified in the Code of This [EASA] AD is considered to be an
p.m., Monday through Friday, except interim action and further AD action may
Federal Regulations, which is published under Federal holidays.
50 titles pursuant to 44 U.S.C. 1510. follow.
Examining the AD Docket The unsafe condition is a high-
The Code of Federal Regulations is sold by
You may examine the AD docket on pressure compressor (HPC) rear hub
the Superintendent of Documents.
the internet at http:// knife edge seal fracture, which could
www.regulations.gov by searching for lead to a sudden increase in high rotor
DEPARTMENT OF TRANSPORTATION and locating Docket No. FAA–2018– vibration and stall in certain IAE
0109; or in person at the Docket PW1100G–JM engines, and consequent
Federal Aviation Administration Operations office between 9 a.m. and 5 IFSDs and rejected takeoffs. You may
p.m., Monday through Friday, except examine the MCAI on the internet at
14 CFR Part 39 Federal holidays. The AD docket http://www.regulations.gov by searching
[Docket No. FAA–2018–0109; Product contains this AD, the regulatory for and locating Docket No. FAA–2018–
Identifier 2018–NM–022–AD; Amendment evaluation, any comments received, and 0109.
39–19196; AD 2018–04–01] other information. The street address for FAA’s Determination and Requirements
RIN 2120–AA64 the Docket Operations office (telephone of This AD
800–647–5527) is in the ADDRESSES This product has been approved by
Airworthiness Directives; Airbus section. Comments will be available in the aviation authority of another
Airplanes the AD docket shortly after receipt. country, and is approved for operation
FOR FURTHER INFORMATION CONTACT: in the United States. Pursuant to our
AGENCY: Federal Aviation
Administration (FAA), DOT. Sanjay Ralhan, Aerospace Engineer, bilateral agreement with the State of
International Section, Transport Design Authority, we have been notified
ACTION: Final rule; request for
Standards Branch, FAA, 1601 Lind of the unsafe condition described in the
comments. Avenue SW, Renton, WA 98057–3356; MCAI. We are issuing this AD because
SUMMARY: We are adopting a new telephone: 425–227–1405; fax: 425– we evaluated all pertinent information
airworthiness directive (AD) for all 227–1149. and determined the unsafe condition
Airbus Model A320–271N, A321–271N, SUPPLEMENTARY INFORMATION: exists and is likely to exist or develop
and A321–272N airplanes. This AD on other products of the same type
Discussion design.
requires de-pairing certain International
Aero Engines (IAE) engines in order to The European Aviation Safety Agency FAA’s Determination of the Effective
continue to operate affected airplanes (EASA), which is the Technical Agent Date
and discontinuing extended operations for the Member States of the European
(ETOPS) for airplanes with at least one Union, has issued EASA Emergency An unsafe condition exists that
affected engine. This AD was prompted Airworthiness Directive 2018–0041–E, requires the immediate adoption of this
by reports of two engine in-flight dated February 9, 2018 (referred to after AD without providing an opportunity
shutdowns (IFSDs) and two rejected this as the Mandatory Continuing for public comments prior to adoption.
takeoffs. We are issuing this AD to Airworthiness Information, or ‘‘the The FAA has found that the risk to the
address the unsafe condition on these MCAI’’), to correct an unsafe condition flying public justifies waiving notice
products. for Airbus Model A320–271N, A321– and comment prior to adoption of this
271N, and A321–272N airplanes, with rule because of an unacceptable rate of
DATES: This AD becomes effective IFSDs and rejected takeoffs on affected
February 15, 2018. certain IAE engines. The MCAI states:
airplanes. Therefore, we determined
We must receive comments on this Several occurrences of engine in-flight that notice and opportunity for public
AD by April 2, 2018. shut-down (IFSD) and Rejected Take-Off
(RTO) have been reported on certain Airbus
comment before issuing this AD are
ADDRESSES: You may send comments, impracticable. In addition, for the
A320neo family aeroplanes. While
using the procedures found in 14 CFR investigation is ongoing to determine the root reasons stated above we find that good
11.43 and 11.45, by any of the following cause, preliminary findings indicate that the cause exists for making this amendment
methods: affected engines, which have high pressure effective in less than 30 days.
• Federal eRulemaking Portal: Go to compressor aft hub modification embodied
http://www.regulations.gov. Follow the from ESN P770450, are more susceptible to Comments Invited
instructions for submitting comments. IFSD. This AD is a final rule that involves
• Fax: 202–493–2251. This condition, if not corrected, could lead requirements affecting flight safety, and
sradovich on DSK3GMQ082PROD with RULES

• Mail: U.S. Department of to dual engine IFSD. we did not precede it by notice and
To address this potentially unsafe opportunity for public comment. We
Transportation, Docket Operations, M–
condition, Airbus issued Alert Operators
30, West Building Ground Floor, Room Transmission (AOT) A71N014–18, providing
invite you to send any written relevant
W12–140, 1200 New Jersey Avenue SE, instructions to de-pair the affected engines data, views, or arguments about this AD.
Washington, DC 20590. and discontinue Extended range Two-engine Send your comments to an address
• Hand Delivery: U.S. Department of aeroplanes Operations (ETOPS) for aircraft listed under the ADDRESSES section.
Transportation, Docket Operations, M– fitted with affected engines. Include ‘‘Docket No. FAA–2018–0109;

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6792 Federal Register / Vol. 83, No. 32 / Thursday, February 15, 2018 / Rules and Regulations

Product Identifier 2018–NM–022–AD’’ airplanes to the Director of the System (e) Reason
at the beginning of your comments. We Oversight Division. This AD was prompted by reports of two
specifically invite comments on the engine in-flight shutdowns (IFSDs) and two
Regulatory Findings rejected takeoffs. We are issuing this AD to
overall regulatory, economic,
environmental, and energy aspects of We determined that this AD will not address a high-pressure compressor (HPC)
this AD. We will consider all comments have federalism implications under rear hub knife edge seal fracture, which
received by the closing date and may Executive Order 13132. This AD will could lead to a sudden increase in high rotor
vibration and stall in certain PW1100G–JM
amend this AD based on those not have a substantial direct effect on engines, and consequent IFSDs or rejected
comments. the States, on the relationship between takeoffs.
We will post all comments we the national government and the States,
receive, without change, to http:// or on the distribution of power and (f) Compliance
www.regulations.gov, including any responsibilities among the various Comply with this AD within the
personal information you provide. We levels of government. compliance times specified, unless already
will also post a report summarizing each For the reasons discussed above, I done.
substantive verbal contact we receive certify that this AD: (g) Affected Engines
about this AD. 1. Is not a ‘‘significant regulatory For the purpose of this AD, affected
action’’ under Executive Order 12866; engines are International Aero Engines Model
Costs of Compliance
2. Is not a ‘‘significant rule’’ under the PW1127G–JM, PW1127GA–JM, PW1130G–
We estimate that this AD affects 8 DOT Regulatory Policies and Procedures JM, PW1133G–JM, and PW1133GA–JM
airplanes of U.S. registry. (44 FR 11034, February 26, 1979); engines, having engine serial numbers
We recognize that this AD may 3. Will not affect intrastate aviation in P770450 and subsequent.
impose certain operational costs. Alaska; and (h) Operational Restrictions
However, we cannot calculate those 4. Will not have a significant (1) No later than 3 flight cycles after the
costs because we do not know how economic impact, positive or negative, effective date of this AD, do not operate an
often the conditions occur. Continued on a substantial number of small entities airplane having two affected engines
operational safety makes these costs under the criteria of the Regulatory installed.
necessary because of the severity of the Flexibility Act. (2) For an airplane having at least one
unsafe condition. affected engine installed: No later than 1
If an operator chooses to replace an List of Subjects in 14 CFR Part 39 flight cycle after the effective date of this AD,
extended operations (ETOPS) are not
affected engine, we estimate it would Air transportation, Aircraft, Aviation allowed.
take 8 work-hours, at $85 per hour, or safety, Incorporation by reference,
$680 per product. Safety. (i) Other FAA AD Provisions
The following provisions also apply to this
Authority for This Rulemaking Adoption of the Amendment AD:
Title 49 of the United States Code Accordingly, under the authority (1) Alternative Methods of Compliance
specifies the FAA’s authority to issue delegated to me by the Administrator, (AMOCs): The Manager, International
rules on aviation safety. Subtitle I, the FAA amends 14 CFR part 39 as Section, Transport Standards Branch, FAA,
section 106, describes the authority of has the authority to approve AMOCs for this
follows: AD, if requested using the procedures found
the FAA Administrator. ‘‘Subtitle VII: in 14 CFR 39.19. In accordance with 14 CFR
Aviation Programs,’’ describes in more PART 39—AIRWORTHINESS 39.19, send your request to your principal
detail the scope of the Agency’s DIRECTIVES inspector or local Flight Standards District
authority. Office, as appropriate. If sending information
We are issuing this rulemaking under ■ 1. The authority citation for part 39 directly to the International Section, send it
the authority described in ‘‘Subtitle VII, continues to read as follows: to the attention of the person identified in
Part A, Subpart III, Section 44701: Authority: 49 U.S.C. 106(g), 40113, 44701. paragraph (j)(2) of this AD. Information may
General requirements.’’ Under that be emailed to 9-ANM-116-AMOC-
§ 39.13 [Amended] REQUESTS@faa.gov. Before using any
section, Congress charges the FAA with
approved AMOC, notify your appropriate
promoting safe flight of civil aircraft in ■ 2. The FAA amends § 39.13 by adding principal inspector, or lacking a principal
air commerce by prescribing regulations the following new airworthiness inspector, the manager of the local flight
for practices, methods, and procedures directive (AD): standards district office/certificate holding
the Administrator finds necessary for 2018–04–01 Airbus: Amendment 39–19196; district office.
safety in air commerce. This regulation Docket No. FAA–2018–0109; Product (2) Contacting the Manufacturer: For any
is within the scope of that authority Identifier 2018–NM–022–AD. requirement in this AD to obtain corrective
because it addresses an unsafe condition actions from a manufacturer, the action must
(a) Effective Date be accomplished using a method approved
that is likely to exist or develop on
This AD becomes effective February 15, by the Manager, International Section,
products identified in this rulemaking
2018. Transport Standards Branch, FAA; or the
action. European Aviation Safety Agency (EASA); or
This AD is issued in accordance with (b) Affected ADs Airbus’s EASA Design Organization
authority delegated by the Executive None. Approval (DOA). If approved by the DOA,
Director, Aircraft Certification Service, the approval must include the DOA-
as authorized by FAA Order 8000.51C. (c) Applicability authorized signature.
sradovich on DSK3GMQ082PROD with RULES

In accordance with that order, issuance This AD applies to Airbus Model A320–
271N, A321–271N, and A321–272N (j) Related Information
of ADs is normally a function of the
airplanes, certificated in any category, all (1) Refer to Mandatory Continuing
Compliance and Airworthiness Airworthiness Information (MCAI) EASA
manufacturer serial numbers.
Division, but during this transition emergency Airworthiness Directive 2018–
period, the Executive Director has (d) Subject 0041–E, dated February 9, 2018, for related
delegated the authority to issue ADs Air Transport Association (ATA) of information. You may examine the MCAI on
applicable to transport category America Code 72, Engine. the internet at http://www.regulations.gov by

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Federal Register / Vol. 83, No. 32 / Thursday, February 15, 2018 / Rules and Regulations 6793

searching for and locating Docket No. FAA– I. Background then requests a classification under
2018–0109. section 513(f)(2).
(2) For more information about this AD, Upon request, FDA has classified the Under the second procedure, rather
contact Sanjay Ralhan, Aerospace Engineer, non-absorbable, hemostatic gauze for than first submitting a 510(k) and then
International Section, Transport Standards temporary internal use as class II a request for classification, if the person
Branch, FAA, 1601 Lind Avenue SW, (special controls), which we have
Renton, WA 98057–3356; telephone: 425–
determines that there is no legally
determined will provide a reasonable marketed device upon which to base a
227–1405; fax: 425–227–1149. assurance of safety and effectiveness. In determination of substantial
(k) Material Incorporated by Reference addition, we believe this action will equivalence, that person requests a
None. enhance patients’ access to beneficial classification under section 513(f)(2) of
innovation, in part by reducing the FD&C Act.
Issued in Renton, Washington, on February
12, 2018.
regulatory burdens by placing the Under either procedure for De Novo
device into a lower device class than the classification, FDA shall classify the
Michael Kaszycki,
automatic class III assignment. device by written order within 120 days.
Acting Director, System Oversight Division,
Aircraft Certification Service. The automatic assignment of class III The classification will be according to
occurs by operation of law and without the criteria under section 513(a)(1) of
[FR Doc. 2018–03185 Filed 2–14–18; 8:45 am]
any action by FDA, regardless of the the FD&C Act. Although the device was
BILLING CODE 4910–13–P
level of risk posed by the new device. automatically placed within class III,
Any device that was not in commercial the De Novo classification is considered
distribution before May 28, 1976, is to be the initial classification of the
automatically classified as, and remains device.
DEPARTMENT OF HEALTH AND We believe this De Novo classification
within, class III and requires premarket
HUMAN SERVICES will enhance patients’ access to
approval unless and until FDA takes an
Food and Drug Administration action to classify or reclassify the device beneficial innovation, in part by
(see 21 U.S.C. 360c(f)(1)). We refer to reducing regulatory burdens. When FDA
21 CFR Part 878 these devices as ‘‘postamendments classifies a device into class I or II via
devices’’ because they were not in the De Novo process, the device can
commercial distribution prior to the serve as a predicate for future devices of
[Docket No. FDA–2018–N–0370] that type, including for 510(k)s (see 21
date of enactment of the Medical Device
Amendments of 1976, which amended U.S.C. 360c(f)(2)(B)(i)). As a result, other
Medical Devices; General and Plastic
the Federal Food, Drug, and Cosmetic device sponsors do not have to submit
Surgery Devices; Classification of the
Act (FD&C Act). a De Novo request or premarket
Non-Absorbable, Hemostatic Gauze for
FDA may take a variety of actions in approval application in order to market
Temporary Internal Use
appropriate circumstances to classify or a substantially equivalent device (see 21
AGENCY: Food and Drug Administration, reclassify a device into class I or II. We U.S.C. 360c(i), defining ‘‘substantial
HHS. may issue an order finding a new device equivalence’’). Instead, sponsors can use
ACTION: Final order. to be substantially equivalent under the less-burdensome 510(k) process,
section 513(i) of the FD&C Act to a when necessary, to market their device.
SUMMARY: The Food and Drug predicate device that does not require II. De Novo Classification
Administration (FDA or we) is premarket approval (see 21 U.S.C.
classifying the non-absorbable, On March 16, 2016, Z-Medica, LLC,
360c(i)). We determine whether a new
hemostatic gauze for temporary internal submitted a request for De Novo
device is substantially equivalent to a
use into class II (special controls). The classification of the D2 Dressing. FDA
predicate by means of the procedures
special controls that apply to the device reviewed the request in order to classify
for premarket notification under section
type are identified in this order and will the device under the criteria for
510(k) of the FD&C Act and part 807 (21
be part of the codified language for the classification set forth in section
U.S.C. 360(k) and 21 CFR part 807,
non-absorbable, hemostatic gauze for 513(a)(1) of the FD&C Act.
respectively). We classify devices into class II if
temporary internal use’s classification. FDA may also classify a device
We are taking this action because we general controls by themselves are
through ‘‘De Novo’’ classification, a insufficient to provide reasonable
have determined that classifying the common name for the process
device into class II (special controls) assurance of safety and effectiveness,
authorized under section 513(f)(2) of the but there is sufficient information to
will provide a reasonable assurance of FD&C Act. Section 207 of the Food and
safety and effectiveness of the device. establish special controls that, in
Drug Administration Modernization Act combination with the general controls,
We believe this action will also enhance of 1997 established the first procedure
patients’ access to beneficial innovative provide reasonable assurance of the
for De Novo classification (Pub. L. 105– safety and effectiveness of the device for
devices, in part by reducing regulatory 115). Section 607 of the Food and Drug
burdens. its intended use (see 21 U.S.C.
Administration Safety and Innovation 360c(a)(1)(B)). After review of the
DATES: This order is effective February Act modified the De Novo application information submitted in the request,
15, 2018. The classification was process by adding a second procedure we determined that the device can be
applicable on June 30, 2017. (Pub. L. 112–144). A device sponsor classified into class II with the
FOR FURTHER INFORMATION CONTACT: may utilize either procedure for De establishment of special controls. FDA
sradovich on DSK3GMQ082PROD with RULES

Peter Hudson, Center for Devices and Novo classification. has determined that these special
Radiological Health, Food and Drug Under the first procedure, the person controls, in addition to the general
Administration, 10903 New Hampshire submits a 510(k) for a device that has controls, will provide reasonable
Ave., Bldg. 66, Rm. G434, Silver Spring, not previously been classified. After assurance of the safety and effectiveness
MD 20993–0002, 301–796–6440, receiving an order from FDA classifying of the device.
peter.hudson@fda.hhs.gov. the device into class III under section Therefore, on June 30, 2017, FDA
SUPPLEMENTARY INFORMATION: 513(f)(1) of the FD&C Act, the person issued an order to the requester

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Document Created: 2018-02-15 00:21:13
Document Modified: 2018-02-15 00:21:13

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Rules and Regulations
Action		Final rule; request for comments.
Dates		This AD becomes effective February 15, 2018.
Contact		Sanjay Ralhan, Aerospace Engineer, International Section, Transport Standards Branch, FAA, 1601 Lind Avenue SW, Renton, WA 98057-3356; telephone: 425-227-1405; fax: 425- 227-1149.
FR Citation		83 FR 6791
RIN Number		2120-AA64
CFR Associated		Air Transportation; Aircraft; Aviation Safety; Incorporation by Reference and Safety

83 FR 6791 - Airworthiness Directives; Airbus Airplanes

DEPARTMENT OF TRANSPORTATIONFederal Aviation Administration

Federal Register Volume 83, Issue 32 (February 15, 2018)

DEPARTMENT OF TRANSPORTATION
Federal Aviation Administration