[Federal Register Volume 87, Number 98 (Friday, May 20, 2022)]
[Rules and Regulations]
[Pages 30794-30797]
[FR Doc No: 2022-10782]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2021-1167; Project Identifier AD-2021-00823-E;
Amendment 39-22034; AD 2022-09-14]
RIN 2120-AA64

Airworthiness Directives; General Electric Company Turbofan
Engines

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: The FAA is superseding Airworthiness Directive (AD) 2019-22-
05, which applied to all General Electric Company (GE) CF34-8C model
turbofan engines. AD 2019-22-05 required initial and repetitive
inspections of the operability bleed valve (OBV) fuel tubes, OBV bleed
air manifold link rod assemblies, and the OBV fuel fittings. AD 2019-
22-05 also required replacement of OBVs or related OBV link rod
hardware that fail inspection. This AD was prompted by multiple reports
of fuel leaks, some leading to engine fires, which have occurred as a
result of malfunctions related to the OBV. Additionally, the
manufacturer has redesigned the OBV, which terminates the need for the
repetitive inspections. This AD requires initial and repetitive
inspections of the OBV fuel tubes, OBV bleed air manifold link rod
assemblies, and the OBV fuel fittings installed on GE CF34-8C model
turbofan engines. This AD requires replacement of OBVs or related OBV
link rod hardware that fail inspection. As a terminating action to the
repetitive inspections, this AD requires replacement of certain OBVs
installed on GE CF34-8C model turbofan engines. This AD also requires
replacement of certain OBVs installed on GE CF34-8E model turbofan
engines. The FAA is issuing this AD to address the unsafe condition on
these products.

DATES: This AD is effective June 24, 2022.
    The Director of the Federal Register approved the incorporation by
reference of certain publications listed in this AD as of June 24,
2022.
    The Director of the Federal Register approved the incorporation by
reference of a certain other publication listed in this AD as of
December 23, 2019 (84 FR 63569, November 18, 2019).

ADDRESSES: For service information identified in this final rule,
contact General Electric Company, 1 Neumann Way, Cincinnati, OH 45215;
phone:<PHONE_NUMBER>; email: [email protected]; website:
https://www.ge.com. You may view this service information at the
Airworthiness Products Section, Operational Safety Branch, FAA, 1200
District Avenue, Burlington, MA 01803. For information on the
availability of this material at the FAA, call<PHONE_NUMBER>. It is
also available at https://www.regulations.gov by searching for and
locating Docket No. FAA-2021-1167.

Examining the AD Docket

    You may examine the AD docket at https://www.regulations.gov by
searching for and locating Docket No. FAA-2021-1167; or in person at
Docket Operations between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays. The AD docket contains this final rule, any
comments received, and other information. The address for Docket
Operations is 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: Scott Stevenson, Aviation Safety
Engineer, ECO Branch, FAA, 1200 District Avenue, Burlington, MA 01803;
phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
[email protected].

SUPPLEMENTARY INFORMATION:

Background

    The FAA issued a notice of proposed rulemaking (NPRM) to amend 14
CFR part 39 to supersede AD 2019-22-05, Amendment 39-19784 (84 FR
63569, November 18, 2019), (AD 2019-22-05). AD 2019-22-05 applied to
all GE CF34-8C1, CF34-8C5, CF34-8C5A1, CF34-8C5B1, CF34-8C5A2, and
CF34-8C5A3 (CF34-8C) model turbofan engines. The NPRM published in the
Federal Register on December 29, 2021 (86 FR 73997). The NPRM was
prompted by multiple reports of fuel leaks, some leading to engine
fires, which have occurred as a result of malfunctions related to the
OBV. Since the FAA issued AD 2019-22-05, the manufacturer redesigned
the OBV, which terminates the need for the repetitive inspections of
the OBV fuel tubes, OBV bleed air manifold link rod assemblies, and the
OBV fuel fittings. Additionally, the FAA determined that GE CF34-8E2,
CF34-8E2A1, CF34-8E5, CF34-8E5A1, CF34-8E5A2, CF34-8E6, and CF34-8E6A1
(CF34-8E) model turbofan engines are susceptible to the same unsafe
condition as the CF34-8C model turbofan engines, and therefore, added
the GE CF34-8E model turbofan engines to the applicability of this AD.
GE published service information specifying procedures to replace
certain OBVs installed on GE CF34-8C and CF34-8E model turbofan
engines. In the NPRM, the FAA proposed to continue to require initial
and repetitive inspections of the OBV fuel tubes, OBV bleed air
manifold link rod assemblies, the OBV fuel fittings installed on GE
CF34-8C model turbofan engines, and replacement of OBVs or related OBV
link rod hardware that fail inspection. In the NPRM, the FAA proposed
to require replacement of certain OBVs installed on GE CF34-8C model
turbofan engines as a terminating action to the repetitive inspections.
In the NPRM, the FAA also proposed to require replacement of certain
OBVs installed on GE CF34-8E model turbofan engines. The FAA is issuing
this AD to address the unsafe condition on these products.

Discussion of Final Airworthiness Directive

Comments

    The FAA received comments from four commenters. The commenters were
Air Line Pilots Association, International (ALPA), Horizon Air, Japan
Airlines (JAL), and SkyWest Airlines, Inc. (SkyWest). The following
presents the comments received on the NPRM and the FAA's response to
each comment.

Request To Add Guidance for OBVs With Unknown Flight Hours (FHs) Since
New

    Horizon Air requested that the FAA provide guidance for compliance
with the Required Actions, paragraphs (g)(4) and (5), in the event the
FHs since new of the OBV is unknown. Horizon Air commented that
paragraphs (g)(4) and (5) of the NPRM would require replacement of the
OBV with a part eligible for installation within prescribed periods,
which are predicated on the FHs since new of the OBV. Horizon Air
reasoned that the NPRM does not include guidance for replacing an OBV
if the FHs since new of the OBV is unknown.
    In response to this comment, the FAA has added paragraph (g)(6) to
this AD, allowing use of the FHs since new of the engine if the
accumulated FHs since new of the OBV is unknown.

Request To Clarify the Reference Date for OBV FHs Since New

    JAL requested that the FAA update paragraph (g)(4) of this AD to
include a reference date for OBV FHs since new. JAL noted that although
paragraph (g)(4) of the NPRM has the OBV FHs since new, it does not
provide a reference date.
    The FAA revised paragraphs (g)(4)(i) through (iii) of this AD to
identify the reference date as requested by the commenter.

Request To Add Service Information Note to the Required Actions

    JAL requested that the FAA add a note referenced in GE CF34-8E
Service Bulletin (SB) 75-0021 R00 to the Required Actions, which
states, ``For all OBVs, if the OBV was upgraded per S/B 75-0018 or the
OBV cap was replaced per GEK 117619, CF34-8E Component Maintenance
Manual (CMM), 80-12-41, Revision 03 or higher, the flight hours since
upgrade or flight hours since the cap was replaced, as applicable, can
be used instead of flight hours since new.''
    In response to JAL's request, the FAA added paragraph (g)(7) to
this AD.

Comments on the Costs of Compliance

    SkyWest commented that they have found the costs to convert part
number (P/N) 4123T71P02 or P/N 4123T71P03 are closer to $25,000 to
$30,000 than the estimated $17,000 stated in the NPRM. SkyWest also
commented that replacing the OBV on CF34-8E engines would take more
than the 2 hours estimated in the NPRM. SkyWest reasoned that in their
experience, it could take 8 hours to replace the OBV on CF34-8E
engines.
    In response to SkyWest's comment regarding the estimated costs to
replace the OBV, the FAA updated the estimated parts costs from $17,230
to $20,330 in the Costs of Compliance section of this AD. The FAA
disagrees with revising the estimated labor cost to replace the OBV.
The cost analysis in AD rulemaking actions typically includes only the
costs associated with complying with the AD and does not include
secondary costs. The FAA's cost estimate includes the estimated work
hours and parts costs to perform the required actions.

Comments on Part Supply Shortages

    SkyWest noted concerns with OBVs modified to P/N 4123T71P06 since
only the original equipment manufacturer (OEM) could modify the OBVs.
SkyWest also commented that the OEM is currently having parts supply
shortages that could jeopardize modifying the OBVs in the required
timeline as proposed in paragraphs (g)(3) and (4) of the NPRM.
    In response to SkyWest's comments, GE has communicated with the
supplier and confirmed there is sufficient capacity and margin to meet
the compliance times required by this AD. GE has also requested that
the supplier plan improvements for engagement and logistics with the
operators.

Support for the AD

    ALPA expressed support for the AD as written.

Conclusion

    The FAA reviewed the relevant data, considered any comments
received, and determined that air safety requires adopting the AD as
proposed. Accordingly, the FAA is issuing this AD to address the unsafe
condition on these products. Except for minor editorial changes, and
any other changes described previously, this AD is adopted as proposed
in the NPRM. None of the changes will increase the economic burden on
any operator.

Related Service Information Under 1 CFR Part 51

    The FAA reviewed GE CF34-8C SB 75-0020 R04, dated May 10, 2019 (GE
SB 75-0020). This SB specifies procedures for inspecting the bleed air
manifold link rod assemblies; the supply, return, and drain fuel
fittings; and the fuel tubes on the OBV. This SB also specifies
procedures for performing corrective actions and replacing any OBVs or
related OBV link rod hardware that fail the inspection criteria. The
Director of the Federal Register approved the incorporation by
reference of GE SB 75-0020 as of December 23, 2019 (84 FR 63569,
November 18, 2019).
    The FAA reviewed GE CF34-8C SB 75-0025 R01, dated August 1, 2019.
This SB specifies procedures for replacing and upgrading the suspect
population of OBVs VIN 5000728-104 (P/N 4123T71P02), VIN 5000728-106
(P/N 4123T71P03), and VIN 5080046-101 (P/N 4123T71P04).
    The FAA reviewed GE CF34-8E SB 75-0019 R01, dated August 1, 2019.
This SB specifies procedures for replacing and upgrading the suspect
population of OBVs VIN 5000728-104 (P/N 4123T71P02), VIN 5000728-106
(P/N 4123T71P03), and VIN 5080046-101 (P/N 4123T71P04).
    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 ADDRESSES.

Other Related Service Information

    The FAA reviewed GE CF34-8C SB 75-0026 R00, dated February 21,
2020. This SB introduces OBV VIN 5080046-103 (P/N 4123T71P06).
    The FAA also reviewed GE CF34-8E SB 75-0021 R00, dated February 21,
2020. This SB introduces OBV VIN 5080046-103 (P/N 4123T71P06).

Costs of Compliance

    The FAA estimates that this AD affects 1,172 engines installed on
airplanes of U.S. registry.
    The FAA estimates the following costs to comply with this AD:

                                                 Estimated Costs
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                                                                                Cost per      Cost on U.S.
                Action                         Labor cost           Parts cost        product        operators
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Replace OBV...........................  2 work-hours x $85 per           $20,330         $20,500     $24,026,000
                                         hour = $170.
Inspect OBV fuel tubes, assemblies,     1 work-hour x $85 per                  0              85          99,620
 and fittings.                           hour = $85.
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    The FAA estimates the following costs to do any necessary
replacements that would be required based on the results of the
inspection. The agency has no way of determining the number of aircraft
that might need this replacement.

                                               On-Condition Costs
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                                                                                Cost per
                    Action                                 Labor cost               Parts cost        product
----------------------------------------------------------------------------------------------------------------
Replace OBV tubes, clamps, and link rod         2.25 work-hours x $85 per hour =       $3,786.25       $3,977.50
 hardware.                                       $191.25.
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Authority for This Rulemaking

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

Regulatory Findings

    The FAA has 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) Will not affect intrastate aviation in Alaska, and
    (3) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

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

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:
0
a. Removing Airworthiness Directive 2019-22-05, Amendment 39-19784 (84
FR 63569, November 18, 2019); and
0
b. Adding the following new airworthiness directive:

2022-09-14 General Electric Company: Amendment 39-22034; Docket No.
FAA-2021-1167; Project Identifier AD-2021-00823-E.

(a) Effective Date

    This airworthiness directive (AD) is effective June 24, 2022.

(b) Affected ADs

    This AD replaces AD 2019-22-05, Amendment 39-19784 (84 FR 63569,
November 18, 2019).

(c) Applicability

    This AD applies to General Electric Company (GE) CF34-8C1, CF34-
8C5, CF34-8C5A1, CF34-8C5B1, CF34-8C5A2, CF34-8C5A3, CF34-8E2, CF34-
8E2A1, CF34-8E5, CF34-8E5A1, CF34-8E5A2, CF34-8E6, and CF34-8E6A1
model turbofan engines.

(d) Subject

    Joint Aircraft System Component (JASC) Code 7532, Compressor
Bleed Valve.

(e) Unsafe Condition

    This AD was prompted by multiple reports of fuel leaks, some
leading to engine fires, which have occurred as a result of
malfunctions related to the operability bleed valve (OBV). The FAA
is issuing this AD to prevent failure of the OBV. The unsafe
condition, if not addressed, could result in an engine fire and
damage to the airplane.

(f) Compliance

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

(g) Required Actions

    (1) For CF34-8C1, CF34-8C5, CF34-8C5A1, and CF34-8C5B1 model
turbofan engines with serial numbers (S/Ns): 965101 through 965670
inclusive; 194101 through 194999 inclusive; and 195101 through
195653 inclusive:
    (i) Within 880 flight hours (FHs) since the previous inspection,
500 FHs after December 23, 2019 (the effective date of AD 2019-22-
05), or 6,880 FHs since new, whichever occurs later, inspect the OBV
bleed air manifold link rod assemblies, the OBV fuel fittings, and
the OBV fuel tubes.
    (ii) Thereafter, within every 880 FHs since the previous
inspection, perform additional repeat inspections of the OBV bleed
air manifold link rod assemblies, the OBV fuel fittings, and the OBV
fuel tubes.
    (iii) Use the Accomplishment Instructions, paragraph 3.B., of GE
CF34-8C Service Bulletin (SB) 75-0020 R04, dated May 10, 2019 (GE SB
75-0020), to perform inspections required by paragraphs (g)(1)(i)
and (ii) of this AD and, per the inspection criteria in paragraph
3.B., of GE SB 75-0020 (the inspection criteria), do the following:
    (A) Before further flight, if fuel leakage is observed at the
OBV fuel fittings or the OBV fuel fittings are loose, replace the
OBV with a part eligible for installation.
    (B) Before further flight, if any OBV fuel tube clamp is found
to be outside the inspection criteria, re-torque the OBV fuel tube
clamp or replace the OBV fuel tube clamp.
    (C) Within 50 flight cycles (FCs) after the inspections required
by paragraphs (g)(1)(i) and (ii) of this AD, replace any link rod
hardware found to be outside the inspection criteria. Until the worn
link rod hardware is replaced, the OBV fuel fittings must be
inspected before the first flight of each day for leakage and
looseness in accordance with the inspection criteria. If the OBV
fuel fittings fail to meet the inspection criteria, before further
flight, replace the OBV and worn link rod hardware.
    (2) For CF34-8C5B1 model turbofan engines with S/Ns not listed
in paragraph (g)(1) of this AD and for all CF34-8C5A2 and CF34-8C5A3
model turbofan engines, perform the following:
    (i) Within 880 FHs after the effective date of this AD or prior
to accumulating 6,880 FHs since new, whichever occurs later, perform
an initial inspection of the OBV bleed air manifold link rod
assemblies, OBV fuel fittings, and OBV fuel tubes.
    (ii) Thereafter, within every 880 FHs since the last inspection,
repeat the inspection of the OBV bleed air manifold link rod
assemblies, OBV fuel fittings, and OBV fuel tubes.
    (iii) Use the Accomplishment Instructions, paragraph 3.B., of GE
SB 75-0020, to perform the inspections in paragraph (g)(2)(i) and
(ii) of this AD and, per the inspection criteria in paragraph 3.B.,
of GE SB 75-0020, do the following:
    (A) Before further flight, if fuel leakage is observed at the
OBV fuel fittings or the OBV fuel fittings are loose, replace the
OBV with a part eligible for installation.
    (B) Before further flight, if any OBV fuel tube clamp is found
to be outside the inspection criteria, re-torque the OBV fuel tube
clamp or replace the OBV fuel tube clamp.

    (C) Within 50 FCs after the inspections required by paragraphs
(g)(2)(i) and (ii) of this AD, replace any link rod hardware found
to be outside the inspection criteria. Until the worn link rod
hardware is replaced, the OBV fuel fittings must be inspected before
the first flight of each day for leakage and looseness in accordance
with the inspection criteria. If the OBV fuel fittings fail to meet
the inspection criteria, before further flight, replace the OBV and
worn link rod hardware.
    (3) For all affected engines with an installed OBV, VIN 5000728-
104 part number (P/N) (P/N 4123T71P02), VIN 5000728-106 (P/N
4123T71P03), or VIN 5080046-101 (P/N 4123T71P04), having an OBV S/N
listed in Appendix A, paragraph 4., of GE CF34-8C SB 75-0025 R01,
dated August 1, 2019 (GE SB 75-0025), or Appendix A, paragraph 4.,
of GE CF34-8E SB 75-0019 R01, dated August 1, 2019 (GE SB 75-0019),
respectively, within 180 days after the effective date of this AD,
remove the OBV and replace with a part eligible for installation.
    (4) For all affected engines with an installed OBV, VIN 5000728-
104 (P/N 4123T71P02), VIN 5000728-106 (P/N 4123T71P03), or VIN
5080046-101 (P/N 4123T71P04), having an OBV S/N not listed in
Appendix A, paragraph 4., of GE SB 75-0025 or Appendix A, paragraph
4., of GE SB 75-0019, respectively, remove the OBV and replace with
a part eligible for installation within the following compliance
times:
    (i) For an OBV that has accumulated more than 25,000 FHs since
new as of the effective date of this AD, remove and replace the OBV
within 16 months of the effective date of this AD.
    (ii) For an OBV that has accumulated between 12,500 to 25,000
FHs since new, inclusive, as of the effective date of this AD,
remove and replace the OBV within 32 months of the effective date of
this AD.
    (iii) For an OBV with fewer than 12,500 FHs since new as of the
effective date of this AD, remove and replace the OBV within 48
months of the effective date of this AD.
    (5) For all affected engines with an installed OBV, VIN 5080046-
102 (P/N 4123T71P05), before the OBV accumulates 25,000 FHs since
new or within 10 years of the effective date of this AD, whichever
occurs first, remove the OBV and replace with a part eligible for
installation.
    (6) For all affected engines with an installed OBV, if the
accumulated FHs since new of the OBV is unknown, use the FHs since
new of the engine.
    (7) If the OBV was upgraded or the OBV cap was replaced using
the service information identified in paragraph 1., Planning
Information, paragraph C., Compliance, of GE CF34-8E SB 75-0021 R00,
dated February 21, 2020, the accumulated FHs since the OBV was
upgraded or accumulated FHs since the OBV cap was replaced, as
applicable, may be used instead of accumulated FHs since new of the
OBV.

(h) Terminating Action

    Installation of an OBV that meets the definition of a part
eligible for installation in paragraph (i) of this AD constitutes
terminating action for the inspections required by paragraphs (g)(1)
and (2) of this AD.

(i) Definition

    For the purpose of this AD, a ``part eligible for installation''
is an OBV VIN 5080046-103 (P/N 4123T71P06) or an OBV reworked to VIN
5080046-103 (P/N 4123T71P06).

(j) No Reporting Requirement

    The reporting instructions specified in GE SB 75-0020 are not
required by this AD.

(k) Credit for Previous Actions

    You may take credit for the initial inspection required by
paragraph (g)(1)(i) or (2)(i) of this AD if you performed this
initial inspection before the effective of this AD using GE CF34-8C
SB 75-0019 R01, dated October 24, 2017, or R00, dated August 4,
2017; or GE CF34-8C-AL S/B 75-0020, Revision 03, dated December 14,
2018, as applicable.

(l) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, ECO 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
ECO Branch, send it to the attention of the person identified in
paragraph (m) of this AD and email to: [email protected].
    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.

(m) Related Information

    For more information about this AD, contact Scott Stevenson,
Aviation Safety Engineer, ECO Branch, FAA, 1200 District Avenue,
Burlington, MA 01803; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>;
email: [email protected].

(n) 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 the AD specifies otherwise.
    (3) The following service information was approved for IBR on
June 24, 2022.
    (i) GE CF34-8C Service Bulletin (SB) 75-0025 R01, dated August
1, 2019.
    (ii) GE CF34-8E SB 75-0019 R01, dated August 1, 2019.
    (4) The following service information was approved for IBR on
December 23, 2019 (84 FR 63569, November 18, 2019).
    (i) GE CF34-8C SB 75-0020 R04, dated May 10, 2019.
    (ii) [Reserved]
    (5) For service information identified in this AD, contact
General Electric Company, 1 Neumann Way, Cincinnati, OH 45215;
phone:<PHONE_NUMBER>; email: [email protected]; website:
https://www.ge.com.
    (6) You may view this service information at FAA, Airworthiness
Products Section, Operational Safety Branch, 1200 District Avenue,
Burlington, MA 01803. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>.
    (7) 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, email: [email protected], or go to: https://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued on May 16, 2022.
Gaetano A. Sciortino,
Deputy Director for Strategic Initiatives, Compliance & Airworthiness
Division, Aircraft Certification Service.
[FR Doc. 2022-10782 Filed 5-19-22; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 86, Number 35 (Wednesday, February 24, 2021)]
[Notices]
[Pages 11303-11304]
[FR Doc No: 2021-03746]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-4951]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Medical Devices;
Humanitarian Use Devices

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.

DATES: Submit written comments (including recommendations) on the
collection of information by March 26, 2021.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0332. Also include the FDA docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Medical Devices; Humanitarian Use Devices--21 CFR Part 814

OMB Control Number 0910-0332--Extension

    This collection of information implements the humanitarian use
devices (HUDs) provision of section 520(m) of the Federal Food, Drug,
and Cosmetic Act (FD&C Act) (21 U.S.C. 360j(m)) and part 814, subpart H
(21 CFR part 814, subpart H). Under section 520(m) of the FD&C Act, FDA
is authorized to exempt an HUD from the effectiveness requirements of
sections 514 and 515 of the FD&C Act (21 U.S.C. 360d and 360e) provided
that the device: (1) Is designed to treat or diagnose a disease or
condition that affects no more than 8,000 individuals in the United
States; (2) would not be available to a person with a disease or
condition unless an exemption is granted and there is no comparable
device other than another HUD approved under this exemption that is
available to treat or diagnose such disease or condition; and (3) will
not expose patients to an unreasonable or significant risk of illness
or injury and the probable benefit to health from the use of the device
outweighs the risk of injury or illness from its use, taking into
account the probable risks and benefits of currently available devices
or alternative forms of treatment.
    Respondents may submit a humanitarian device exemption (HDE)
application seeking exemption from the effectiveness requirements of
sections 514 and 515 of the FD&C Act as authorized by section 520(m)(2)
of the FD&C Act. The information collected will assist FDA in making
determinations on the following: (1) Whether to grant HUD designation
of a medical device; (2) whether to exempt an HUD from the
effectiveness requirements under sections 514 and 515 of the FD&C Act,
provided that the device meets requirements set forth under section
520(m) of the FD&C Act; and (3) whether to grant marketing approval(s)
for the HUD. Failure to collect this information would prevent FDA from
making a determination on the factors listed previously in this
document. Further, the collected information would also enable FDA to
determine whether the holder of an HUD is in compliance with the HUD
provisions under section 520(m) of the FD&C Act.
    In the Federal Register of August 13, 2020 (85 FR 49379), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. Although two comments were received, they
were not responsive to the four collection of information topics
solicited.
    FDA estimates the burden of this collection of information as
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of
     Activity/21 CFR section         Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
----------------------------------------------------------------------------------------------------------------
Request for HUD designation--                 20               1              20              40             800
 814.102........................
HDE Application--814.104........               4               1               4             328           1,312
HDE Amendments and resubmitted                20               5             100              50           5,000
 HDEs--814.106..................
HDE Supplements--814.108........             116               1             116              80           9,280
Notification of withdrawal of an               2               1               2               1               2
 HDE--814.116(e)(3).............
Notification of withdrawal of                  1               1               1               2               2
 institutional review board
 approval--814.124(b)...........
Periodic reports--814.126(b)(1).              50               1              50             120           6,000
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............          22,396
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

                                                   Table 2--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of                       Average burden
                      Activity/21 CFR section                           Number of       records per      Total annual         per          Total hours
                                                                      recordkeepers     recordkeeper       records       recordkeeping
--------------------------------------------------------------------------------------------------------------------------------------------------------
HDE Records--814.126(b)(2).........................................              62                1               62                2              124
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

                                               Table 3--Estimated Annual Third-Party Disclosure Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of
                      Activity/21 CFR section                           Number of     disclosures per    Total annual    Average burden    Total hours
                                                                       respondents       respondent      disclosures     per disclosure
--------------------------------------------------------------------------------------------------------------------------------------------------------
Notification of emergency use--814.124(a)..........................              22                1               22                1               22
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    The number of respondents in tables 1, 2, and 3 are an average
based on data for the previous 3 years, i.e., fiscal years 2017 through
2019. The number of respondents has been adjusted to reflect updated
respondent data. This has resulted in an overall increase of 5,803
hours to the total estimated burden. The number of annual reports
submitted under Sec.  814.126(b)(1) in table 1 reflects 50 respondents
with approved HUD applications. Based on further review, the estimated
number of recordkeepers has been adjusted from 65 respondents to 62
respondents in table 2 to reflect the most current data available.
Therefore, under Sec.  814.126(b)(2) in table 2, the estimated number
of recordkeepers is 62.
    We have also updated the burden estimate consistent with new
provisions in Sec.  814.104(b)(4)(i) regarding ``Human Subject
Protection; Acceptance of Data from Clinical Investigations for Medical
Devices'' (83 FR 7366; February 21, 2018) (approved under OMB control
number 0910-0741). Section 814.104 is being amended to address
submission of data from clinical investigations in an HDE. To the
extent the applicant includes data from clinical investigations, the
applicant will be required to include the information and statements as
described in Sec.  814.104(b)(4)(i). Consistent with our estimate in
OMB control number 0910-0741, this revision increases our burden
estimate for an HDE by 8 hours per submission.

    Dated: February 16, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-03746 Filed 2-23-21; 8:45 am]
BILLING CODE 4164-01-P