[Federal Register: July 27, 2010 (Volume 75, Number 143)]
[Proposed Rules]
[Page 43878-43881]
[DOCID:fr27jy10-23]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2009-0864; Directorate Identifier 2008-NM-202-AD]
RIN 2120-AA64

Airworthiness Directives; DASSAULT AVIATION Model Falcon 10
Airplanes; Model FAN JET FALCON, FAN JET FALCON SERIES C, D, E, F, and
G Airplanes; Model MYSTERE-FALCON 200 Airplanes; Model MYSTERE-FALCON
20-C5, 20-D5, 20-E5, and 20-F5 Airplanes; Model FALCON 2000 and FALCON
2000EX Airplanes; and Model MYSTERE-FALCON 50 and MYSTERE-FALCON 900
Airplanes, and FALCON 900EX Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Supplemental notice of proposed rulemaking (NPRM); reopening of
comment period.

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SUMMARY: We are revising an earlier NPRM for the products listed above.
This action revises the earlier NPRM by expanding the scope. This
proposed AD results from mandatory continuing airworthiness information
(MCAI) originated by an aviation authority of another country to
identify and correct an unsafe condition on an aviation product. The
MCAI describes the unsafe condition as:

    During maintenance on one aircraft, it was discovered that the
overpressure capsules were broken on both pressurization valves.
Failure of the pressurization control regulating valve (overpressure
capsule) will affect the aircraft's overpressure protection * * *.
* * * * *
The unsafe condition is overpressurization, which can result in injury
to the occupants and possible structural failure leading to loss of
control of the airplane. The proposed AD would require actions that are
intended to address the unsafe condition described in the MCAI.

DATES: We must receive comments on this proposed AD by August 23, 2010.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Portal: Go to http://
www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     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 W12-40, 1200 New
Jersey Avenue, SE., Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.
    For service information identified in this proposed AD, contact
Dassault Falcon Jet, P.O. Box 2000, South Hackensack, New Jersey 07606;
telephone<PHONE_NUMBER>; Internet  http://www.dassaultfalcon.com. You
may review copies of the referenced service information at the FAA,
Transport Airplane Directorate, 1601 Lind Avenue, SW., Renton,
Washington. For information on the availability of this material at the
FAA, call<PHONE_NUMBER>.

Examining the AD Docket

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

FOR FURTHER INFORMATION CONTACT: Tom Rodriguez, Aerospace Engineer,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
1601 Lind Avenue, SW., Renton, Washington 98057-3356; telephone (425)
227-1137; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2009-0864;
Directorate Identifier 2008-NM-202-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed 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 proposed AD.

Discussion

    We proposed to amend 14 CFR part 39 with an earlier NPRM for some
of the specified products, which was published in the Federal Register
on September 21, 2009 (74 FR 48021). That earlier NPRM proposed to
require actions intended to address the unsafe condition for the
products listed above.
    Since that NPRM was issued, we have determined that Model FAN JET
FALCON SERIES C, D, E, F, and G airplanes are also subject to the
identified unsafe condition. We have revised the applicability in this
supplemental NPRM to include these airplanes.

Comments

    We have considered the following comments received on the earlier
NPRM.

Request To Extend Compliance Time for Certain Airplanes

    Dassault Aviation (Dassault) requests that we extend the compliance
times in Table 1 of the earlier NPRM for Model MYSTERE-FALCON 900,
FALCON 900EX, Model FALCON 2000, and FALCON 2000EX airplanes from 1,630
flight hours to 1,640 flight hours. Dassault explains that 1,640 flight
hours is the correct amount of time for the 1,600-flight-hour B-check
interval and +40-flight-hour tolerance indicated in the ``General''
section of each airplane's Chapter 5 Maintenance Schedule. Dassault
notes that this extended compliance time has been approved by the
European Aviation Safety Agency.
    We agree, for the reasons provided by the commenter. We have
revised Table 1 of this supplemental NPRM accordingly.

Request To Include Current Maintenance Procedure

    Dassault requests that we identify the current maintenance
procedures in the AD. Dassault explains that later versions of the
maintenance procedures have been created since the earlier NPRM was
issued. Dassault also suggests that we add the phrase for Table 2 of
this AD, ``as may be amended from time to time by Dassault Aviation.''
    We partially agree. For the reasons provided by the commenter, we
agree to identify the current maintenance procedures and have revised
the Maintenance Procedure column of Table 2 of this supplemental NPRM
accordingly. We do not agree to add the phrase, ``as may be amended
from time to time by Dassault Aviation,'' as it contradicts FAA policy.
We cannot refer to procedures or documents in our AD that do not yet
exist. Operators may request approval to use a later revision of the
specified maintenance procedure as an alternative method of compliance
with the proposed requirements under the provisions of paragraph (h)(1)
of this supplemental NPRM.

Explanation of Change Made to This Supplemental NPRM

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

FAA's Determination and Requirements of This Proposed 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 and service
information referenced above. We are proposing this AD because we
evaluated all pertinent information and determined an unsafe condition
exists and is likely to exist or develop on other products of the same
type design.
    Certain changes described above expand the scope of the earlier
NPRM. As a result, we have determined that it is necessary to reopen
the comment period to provide additional opportunity for the public to
comment on this proposed AD.

Differences Between This AD and the MCAI or Service Information

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

policies. Any such differences are highlighted in a Note within the
proposed AD.

Explanation of Change to Costs of Compliance

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

Costs of Compliance

    Based on the service information, we estimate that this proposed AD
would affect about 1,082 products of U.S. registry. We also estimate
that it would take about 1 work-hour per product to comply with the
basic requirements of this proposed AD. The average labor rate is $85
per work-hour. Based on these figures, we estimate the cost of the
proposed AD on U.S. operators to be $91,970, or $85 per product.

Authority for This Rulemaking

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

Regulatory Findings

    We determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect on the States, on the relationship
between the national Government and the States, or on the distribution
of power and responsibilities among the various levels of government.
    For the reasons discussed above, I certify this proposed
regulation:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979); and
    3. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    We prepared a regulatory evaluation of the estimated costs to
comply with this proposed AD and placed it in the AD docket.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Safety.

The Proposed Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA proposes to amend 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

    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]

    2. The FAA amends Sec.  39.13 by adding the following new AD:

Dassault Aviation: Docket No. FAA-2009-0864; Directorate Identifier
2008-NM-202-AD.

Comments Due Date

    (a) We must receive comments by August 23, 2010.

Affected ADs

    (b) None.

Applicability

    (c) This AD applies to the airplanes identified in paragraphs
(c)(1) and (c)(2) of this AD, certificated in any category.
    (1) DASSAULT AVIATION Model Falcon 10 airplanes, Model FAN JET
FALCON, FAN JET FALCON SERIES C, D, E, F, and G airplanes, and Model
MYSTERE-FALCON 20-C5, 20-D5, 20-E5, and 20-F5 airplanes; all serial
numbers, equipped with Liebherr or ABG-Semca pressurization outflow
valves.
    (2) DASSAULT AVIATION Model MYSTERE-FALCON 200 airplanes, Model
MYSTERE-FALCON 50 and MYSTERE-FALCON 900, and FALCON 900EX
airplanes, and Model FALCON 2000 and FALCON 2000EX airplanes; all
serial numbers.

Subject

    (d) Air Transport Association (ATA) of America Code 21: Air
Conditioning.

Reason

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

    ``During maintenance on one aircraft, it was discovered that the
overpressure capsules were broken on both pressurization valves.
Failure of the pressurization control regulating valve (overpressure
capsule) will affect the aircraft's overpressure protection * * *''.
* * * * *
    The unsafe condition is overpressurization, which can result in
injury to the occupants and possible structural failure leading to
loss of control of the airplane.

Compliance

    (f) You are responsible for having the actions required by this
AD performed within the compliance times specified, unless the
actions have already been done.

Inspection and Replacement

    (g) Unless already done, do the following actions
    (1) Within 6 months after the effective date of this AD, or
before reaching the applicable time in the ``Inspection Threshold''
column specified in Table 1 of this AD, whichever occurs later, and
thereafter at intervals not to exceed the applicable time in the
``Inspection Interval'' column specified in Table 1 of this AD:
Inspect for overpressure tightness on both regulating valves using a
method approved by either the Manager, International Branch, ANM-
116, Transport Airplane Directorate, FAA; or the European Aviation
Safety Agency (EASA) (or its delegated agent).

                                            Table 1--Compliance Times
----------------------------------------------------------------------------------------------------------------

----------------------------------------------------------------------------------------------------------------
        Affected airplanes           Inspection threshold (whichever occurs           Inspection interval
                                                      later)
----------------------------------------------------------------------------------------------------------------
Model FAN JET FALCON, FAN JET      Prior to the          Within 1,250 flight   1,250 flight hours.
 FALCON SERIES C, D, E, F, and G    accumulation of       hours after the
 airplanes, and Model               1,250 total flight    valve was cleaned
 MYSTERE[dash]FALCON 20-C5, 20-     hours on the          in accordance with
 D5, 20-E5, and 20-F5 airplanes     regulating valve      this AD.
 equipped with Liebherr or ABG-     since new.
 Semca valves part number (P/N)
 209xx0xxx0x;
Model MYSTERE[dash]FALCON 200
 airplanes;

Model Falcon 10 airplanes,
 equipped with Liebherr or ABG-
 Semca valves P/N 209xx0xxx0x.
Model MYSTERE[dash]FALCON 50       Prior to the          Within 1,630 flight   1,630 flight hours.
 airplanes.                         accumulation of       hours after the
                                    1,630 total flight    valve was cleaned
                                    hours on the          in accordance with
                                    regulating valve      this AD.
                                    since new.
Model MYSTERE[dash]FALCON 900,     Prior to the          Within 1,640 flight   1,640 flight hours.
 FALCON 900EX (including ``F900EX-  accumulation of       hours after the
 EASy'' and ``F900DX''), Model      1,640 total flight    valve was cleaned
 FALCON 2000, and FALCON 2000EX     hours on the          in accordance with
 (including ``F2000EX-EASy'' and    regulating valve      this AD.
 ``F2000DX'') airplanes.            since new.
----------------------------------------------------------------------------------------------------------------

    Note 1: Guidance on inspecting for overpressure tightness on
both regulating valves can be found in the applicable airplane
maintenance manual identified in Table 2 of this AD.

                                      Table 2--Maintenance Manual Guidance
----------------------------------------------------------------------------------------------------------------
                                         See Dassault
     For affected airplanes--      maintenance procedure--                 In maintenance manual--
----------------------------------------------------------------------------------------------------------------
Model Falcon 10 airplanes,         21-32-01, dated July     Dassault Falcon 10 Maintenance Manual.
 equipped with Liebherr or ABG-     2009.
 Semca valves P/N 209xx0xxx0x.
Model FALCON 900EX (including      21-314, dated September  Dassault Falcon 900EX EASy Maintenance Manual.
 ``F900EX-EASy'' and ``F900DX'')    2008.
 airplanes.
Model FALCON 2000 and FALCON       21-314, dated November   Dassault Falcon 2000 Maintenance Manual.
 2000EX (including ``F2000EX-       2008.
 EASy'') airplanes.
Model FALCON F2000DX airplanes...  21-314, dated November   Dassault Falcon 2000DX Maintenance Manual.
                                    2008.
Model FAN JET FALCON, FAN JET
 FALCON SERIES C, D, E, F, and G
 airplanes,.
MYSTERE-FALCON 20-C5, 20-D5,.....  21-31-10, dated October  Dassault Fan Jet Falcon Maintenance Manual.
20-E5, and 20-F5 airplanes;         2008.
 equipped with Liebherr or ABG-
 Semca valves part number (P/N)
 209xx0xxx0x.
Model MYSTERE-FALCON 50 airplanes  21-160, dated January    Dassault Falcon 50/50EX Maintenance Manual.
                                    2009.
Model MYSTERE-FALCON 200           051.0, dated December    Dassault Falcon 200 Maintenance Manual.
 airplanes.                         2008.
Model MYSTERE-FALCON 900           21-308, dated October    Dassault Falcon 900 Maintenance Manual.
 airplanes.                         2008.
----------------------------------------------------------------------------------------------------------------

     (2) If any leak is found during any inspection required by
paragraph (g)(1) of this AD, before further flight, replace the
affected valve with a serviceable unit, using a method approved by
either the Manager, International Branch, ANM-116, Transport
Airplane Directorate, FAA; or the EASA (or its delegated agent).

    Note 2:  Guidance on replacing regulating valves can be found in
the applicable airplane maintenance manual identified in Table 2 of
this AD.

FAA AD Differences

    Note 3: This AD differs from the MCAI as follows: Although
paragraph (3) of the compliance section of the MCAI allows flight in
accordance with the master minimum equipment list (MMEL) provisions
after leaks are found, paragraph (g)(2) of this AD requires
replacing affected valves before further flight.

Other FAA AD Provisions

    (h) The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
has the authority to approve AMOCs for this AD, if requested using
the procedures found in 14 CFR 39.19. Send information to Attn: Tom
Rodriguez, Aerospace Engineer, International Branch, ANM-116,
Transport Airplane Directorate, FAA, 1601 Lind Avenue, SW., Renton,
Washington 98057-3356; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>.
Before using any approved AMOC on any airplane to which the AMOC
applies, notify your principal maintenance inspector (PMI) or
principal avionics inspector (PAI), as appropriate, or lacking a
principal inspector, your local Flight Standards District Office.
The AMOC approval letter must specifically reference this AD.
    (2) Airworthy Product: For any requirement in this AD to obtain
corrective actions from a manufacturer or other source, use these
actions if they are FAA-approved. Corrective actions are considered
FAA-approved if they are approved by the State of Design Authority
(or their delegated agent). You are required to assure the product
is airworthy before it is returned to service.
    (3) Reporting Requirements: For any reporting requirement in
this AD, under the provisions of the Paperwork Reduction Act (44
U.S.C. 3501 et seq.), the Office of Management and Budget (OMB) has
approved the information collection requirements and has assigned
OMB Control Number 2120-0056.

Related Information

    (i) Refer to MCAI EASA Airworthiness Directive 2008-0072, dated
April 18, 2008, for related information.

    Issued in Renton, Washington, on July 16, 2010.
Ali Bahrami,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2010-18292 Filed 7-26-10; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 85, Number 144 (Monday, July 27, 2020)]
[Rules and Regulations]
[Pages 45075-45078]
[FR Doc No: 2020-16127]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2020-0136; Project Identifier MCAI-2019-00114-E;
Amendment 39-21168; AD 2020-15-05]
RIN 2120-AA64

Airworthiness Directives; Austro Engine GmbH Engines

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: The FAA is superseding Airworthiness Directive (AD) 2018-18-02
for certain Austro Engine GmbH model E4 engines and all Austro Engine
GmbH model E4P engines. AD 2018-18-02 required replacement of the
timing chain and amending certain airplane flight manuals (AFMs) to
limit the use of windmill restarts. This AD requires amendment of
certain existing AFMs to limit the use of windmill restarts and removes
the timing chain replacement requirement in AD 2018-18-02. This AD was
prompted by reports of considerable wear of the timing chain on the
affected engines. The FAA is issuing this AD to address the unsafe
condition on these products.

DATES: This AD is effective August 31, 2020.
    The Director of the Federal Register approved the incorporation by
reference

of certain publications listed in this AD as of August 31, 2020.

ADDRESSES: For service information identified in this final rule,
contact Diamond Aircraft Industries, N. A., Otto-Stra[beta]e 5, A-2700
Wiener Neustadt, A2700, Austria; phone: +43 2622 26700; fax: +43 2622
26780; website: www.diamondaircraft.com. You may view this service
information at the 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 781-
238-7759. It is also available on the internet at https://www.regulations.gov by searching for and locating Docket No. FAA-2020-
0136.

Examining the AD Docket

    You may examine the AD docket on the internet at https://www.regulations.gov by searching for and locating Docket No. FAA-2020-
0136; 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, the mandatory continuing airworthiness information
(MCAI), 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: Mehdi Lamnyi, Aerospace Engineer, ECO
Branch, FAA, 1200 District Avenue, Burlington, MA 01803; phone: 781-
238-7743; fax:<PHONE_NUMBER>; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Discussion

    The FAA issued a notice of proposed rulemaking (NPRM) to amend 14
CFR part 39 to supersede AD 2018-18-02, Amendment 39-19381 (83 FR
53802, October 25, 2018), (``AD 2018-18-02''). AD 2018-18-02 applied to
certain Austro Engine GmbH model E4 engines and all Austro Engine GmbH
model E4P engines. The NPRM published in the Federal Register on March
17, 2020 (85 FR 15079). The NPRM was prompted by reports of
considerable wear of the timing chain on the affected engines. The NPRM
proposed to retain the requirements of AD 2018-18-02 for amending
certain AFMs to limit the use of windmill restarts to emergency
procedures. The NPRM also proposed to remove the requirement in AD
2018-18-02 for replacing the timing chain. The FAA is issuing this AD
to address the unsafe condition on these products.
    The European Union Aviation Safety Agency (EASA), which is the
Technical Agent for the Member States of the European Community, has
issued EASA AD 2017-0103R1, dated February 25, 2019 (referred to after
this as ``the MCAI''), to address the unsafe condition on these
products. The MCAI states:

    Considerable wear of the timing chain has been detected on some
engines. This may have been caused by windmilling restarts, which
are known to cause high stress to the timing chain. This condition,
if not detected and corrected, could lead to failure of the timing
chain and consequent engine power loss, possibly resulting in
reduced control of the aeroplane.
    To address this potential unsafe condition, AE included
instructions in the engine maintenance manual to periodically
inspect the condition of the timing chain and, depending on
findings, to replace the timing chain and the chain wheel. The
operation manual was updated to allow windmilling restart only as an
emergency procedure. AE also published Mandatory Service Bulletin
(MSB) MSB-E4-017/2, providing instructions to replace the timing
chain for engines with known windmilling restarts, and EASA issued
AD 2017-0103, requiring replacement of the timing chain for engines
with known windmilling restarts, and amendment of the applicable
Aircraft Flight Manual (AFM). Since that [EASA] AD was issued, AE
revised the applicable Airworthiness Limitation Section (ALS)
including, among others, the limitation required by that AD.
Consequently, EASA published AD 2019-0041, requiring accomplishment
of the actions specified in the ALS.
    For the reason described above, this [EASA] AD is revised
accordingly, removing the requirement of timing chain replacement.
This action remain required through EASA AD 2019-0041.

    You may obtain further information by examining the MCAI in the AD
docket on the internet at https://www.regulations.gov by searching for
and locating Docket No. FAA-2020-0136.

Comments

    The FAA gave the public the opportunity to participate in
developing this final rule. The FAA received no comments on the NPRM or
on the determination of the cost to the public.

Conclusion

    The FAA reviewed the relevant data and determined that air safety
and the public interest require adopting this final rule as proposed
except for minor editorial changes. The FAA has determined that these
minor changes:
     Are consistent with the intent that was proposed in the
NPRM for addressing 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

    The FAA reviewed Diamond Aircraft (DA) Temporary Revision (TR) TR-
M[Auml]M-42-973, dated August 12, 2016, for the Diamond Aircraft
Industries (DAI) model DA 42 NG Airplane Flight Manual (AFM) and DA TR
TR-M[Auml]M-62-240, dated August 12, 2016, for the DAI model DA 62 AFM.
These TRs define the removal of the normal operation procedure for
windmilling restart for the respective airplanes. 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

    The FAA estimates that this AD affects 211 engines installed on
airplanes of U.S. registry.
    The FAA estimates the following costs to comply with this AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per      Cost on U.S.
                Action                         Labor cost           Parts cost        product        operators
----------------------------------------------------------------------------------------------------------------
Amend AFM.............................  1 work-hour x $85 per                 $0             $85         $17,935
                                         hour = $85.
----------------------------------------------------------------------------------------------------------------

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

    This AD will not have federalism implications under Executive Order
13132. This AD will not have a substantial direct effect on the States,
on the relationship between the national government and the States, or
on the distribution of power and responsibilities among the various
levels of government.
    For the reasons discussed above, I certify this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) 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.

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.  9.13  [Amended]

0
2. The FAA amends Sec.  39.13 by:
0
a. Removing AD 2018-18-02, Amendment 39-19381 (83 FR 53802, October 25,
2018); and
0
b. Adding the following new airworthiness directive (AD):

2020-15-05 Austro Engine GmbH: Amendment 39-21168; Docket No. FAA-
2020-0136; Project Identifier MCAI-2019-00114-E.

(a) Effective Date

    This AD is effective August 31, 2020.

(b) Affected ADs

    This AD replaces AD 2018-18-02, Amendment 39-19381 (83 FR 53802,
October 25, 2018).

(c) Applicability

    This AD applies to Austro Engine GmbH model E4 engines with
serial numbers that have a ``-B'' or ``-C'' configuration and to
model E4P engines, all serial numbers.

(d) Subject

    Joint Aircraft System Component (JASC) Code 8520, Reciprocating
Engine Power Section.

(e) Unsafe Condition

    This AD was prompted by reports of considerable wear of the
timing chain on the affected engines. The FAA is issuing this AD to
prevent failure of the engine timing chain. The unsafe condition, if
not addressed, could result in failure of the engine timing chain,
loss of engine thrust control, and reduced control of the airplane.

(f) Compliance

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

(g) Required Actions

    (1) Within 30 days after the effective date of this AD, under
the Emergency Procedures chapter, amend the applicable airplane
flight manual (AFM) by adding the information in Figure 1 to
paragraph (g)(1) of this AD to limit the use of a windmilling
restart to only an emergency procedure.

[GRAPHIC] [TIFF OMITTED] TR27JY20.001

    (2) For affected Austro Engine GmbH model E4 engines installed
on Diamond Aircraft Industries (DAI) model Diamond Aircraft (DA) 42
NG and DA 42 M-NG airplanes, and for Austro Engine GmbH model E4P
engines installed on DAI model DA 62 airplanes, using DA AFM
Temporary Revision (TR) TR-M[Auml]M-42-973, and DA AFM TR TR-
M[Auml]M-62-240, both dated August 12, 2016, to update the
applicable AFM is an acceptable method to comply with paragraph
(g)(1) of this AD.

(h) Credit for Previous Actions

    You may take credit for actions required by paragraph (g) of
this AD if you amended the applicable AFM for the airplane with the
affected engine installed before the effective date of this AD in
accordance with AD 2018-18-02.

(i) 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 (j)(1) of this AD. You may email your request to<EMAIL_ADDRESS>    (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.

(j) Related Information

    (1) For more information about this AD, contact Mehdi Lamnyi,
Aerospace Engineer, ECO Branch, FAA, 1200 District Avenue,
Burlington, MA, 01803; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>;
email<EMAIL_ADDRESS>    (2) Refer to European Union Aviation Safety Agency (EASA) AD
2017-0103R1, dated February 25, 2019, for more information. You may
examine the EASA AD in the AD docket on the internet at https://www.regulations.gov by searching for and locating it in Docket No.
FAA-2020-0136.

(k) 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.
    (i) Diamond Aircraft (DA) Temporary Revision (TR) TR-M[Auml]M-
42-973, dated August 12, 2016, for the Diamond Aircraft Industries
(DAI) model DA 42 NG Airplane Flight Manual (AFM).
    (ii) DA AFM TR TR-M[Auml]M-62-240, dated August 12, 2016, for
the DAI model DA 62 AFM.
    (3) For Diamond Aircraft Industries service information
identified in this AD, contact Diamond Aircraft Industries, N.A.,
Otto-Stra[beta]e 5, A-2700 Wiener Neustadt, A2700, Austria; phone:
+43 2622 26700; fax: +43 2622 26780; website:
www.diamondaircraft.com.
    (4) You may view this service information at the 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>.
    (5) 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_ADDRESS>or go to: https://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued on July 9, 2020.
Lance T. Gant,
Director, Compliance & Airworthiness Division, Aircraft Certification
Service.
[FR Doc. 2020-16127 Filed 7-24-20; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 81, Number 242 (Friday, December 16, 2016)]
[Notices]
[Pages 91239-91242]
[FR Doc No: 2016-30286]

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

DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-1999-6480; FMCSA-2001-11426; FMCSA-2002-11714; FMCSA-
2002-12844; FMCSA-2003-16564; FMCSA-2004-19477; FMCSA-2005-21711;
FMCSA-2005-22727; FMCSA-2005-23099; FMCSA-2006-23773; FMCSA-2006-24015;
FMCSA-2008-0021; FMCSA-2009-0011; FMCSA-2009-0303; FMCSA-2009-0321;
FMCSA-2010-0050; FMCSA-2011-0142; FMCSA-2011-0299; FMCSA-2011-0366;
FMCSA-2011-0379; FMCSA-2011-0380; FMCSA-2012-0039; FMCSA-2013-0174;
FMCSA-2014-0002; FMCSA-2014-0003; FMCSA-2014-0004]

Qualification of Drivers; Exemption Applications; Vision

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

ACTION: Notice of renewal of exemptions; request for comments.

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

SUMMARY: FMCSA announces its decision to renew the exemptions from the
vision requirement in the Federal Motor Carrier Safety Regulations for
131 individuals. FMCSA has statutory authority to exempt individuals
from the vision requirement if the exemptions granted will not
compromise safety. The Agency has concluded that granting these
exemption renewals will provide a level of safety that is equivalent to
or greater than the level of safety maintained without the exemptions
for these commercial motor vehicle (CMV) drivers.

DATES: Each group of renewed exemptions was effective from the dates
stated in the discussions below. Comments must be received on or before
January 17, 2017.

ADDRESSES: You may submit comments bearing the Federal Docket
Management System (FDMS) numbers: Docket No. [Docket No. FMCSA-1999-
6480; FMCSA-2001-11426; FMCSA-2002-11714; FMCSA-2002-12844; FMCSA-

2003-16564; FMCSA-2004-19477; FMCSA-2005-21711; FMCSA-2005-22727;
FMCSA-2005-23099; FMCSA-2006-23773; FMCSA-2006-24015; FMCSA-2008-0021;
FMCSA-2009-0011; FMCSA-2009-0303; FMCSA-2009-0321; FMCSA-2010-0050;
FMCSA-2011-0142; FMCSA-2011-0299; FMCSA-2011-0366; FMCSA-2011-0379;
FMCSA-2011-0380; FMCSA-2012-0039; FMCSA-2013-0174; FMCSA-2014-0002;
FMCSA-2014-0003; FMCSA-2014-0004], using any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the on-line instructions for submitting
comments.
     Mail: Docket Management Facility; U.S. Department of
Transportation, 1200 New Jersey Avenue SE., West Building Ground Floor,
Room W12-140, Washington, DC 20590-0001.
     Hand Delivery or Courier: West Building Ground Floor, Room
W12-140, 1200 New Jersey Avenue SE., Washington, DC, between 9 a.m. and
5 p.m., e.t., Monday through Friday, except Federal Holidays.
     Fax: 1-202-493-2251.
    Instructions: Each submission must include the Agency name and the
docket number for this notice. Note that DOT posts all comments
received without change to http://www.regulations.gov, including any
personal information included in a comment. Please see the Privacy Act
heading below.
    Docket: For access to the docket to read background documents or
comments, go to http://www.regulations.gov at any time or Room W12-140
on the ground level of the West Building, 1200 New Jersey Avenue SE.,
Washington, DC, between 9 a.m. and 5 p.m., e.t., Monday through Friday,
except Federal holidays. The Federal Docket Management System (FDMS) is
available 24 hours each day, 365 days each year. If you want
acknowledgment that we received your comments, please include a self-
addressed, stamped envelope or postcard or print the acknowledgement
page that appears after submitting comments on-line.
    Privacy Act: Anyone may search the electronic form of all comments
received into any of our dockets by the name of the individual
submitting the comment (or of the person signing the comment, if
submitted on behalf of an association, business, labor union, etc.).
You may review DOT's Privacy Act Statement for the Federal Docket
Management System (FDMS) published in the Federal Register on January
17, 2008 (73 FR 3316).

FOR FURTHER INFORMATION CONTACT: Ms. Christine A. Hydock, Chief,
Medical Programs Division, Medical Programs Division,<PHONE_NUMBER>,
<EMAIL_ADDRESS>FMCSA, Department of Transportation, 1200 New
Jersey Avenue SE., Room W64-224, Washington, DC 20590-0001. Office
hours are from 8:30 a.m. to 5 p.m., e.t., Monday through Friday, except
Federal holidays.

SUPPLEMENTARY INFORMATION:

Background

    Under 49 U.S.C. 31136(e) and 31315, FMCSA may renew an exemption
from the vision requirements in 49 CFR 391.41(b)(10), which applies to
drivers of CMVs in interstate commerce, for a two-year period if it
finds ``such exemption would likely achieve a level of safety that is
equivalent to or greater than the level that would be achieved absent
such exemption.'' The procedures for requesting an exemption (including
renewals) are set out in 49 CFR part 381.

Exemption Decision

    This notice addresses 131 individuals who have requested renewal of
their exemptions in accordance with FMCSA procedures. FMCSA has
evaluated these 131 applications for renewal on their merits and
decided to extend each exemption for a renewable two-year period. Each
individual is identified according to the renewal date.
    The exemptions are extended subject to the following conditions:
(1) That each individual has a physical examination every year (a) by
an ophthalmologist or optometrist who attests that the vision in the
better eye continues to meet the requirements in 49 CFR 391.41(b)(10),
and (b) by a medical examiner who attests that the individual is
otherwise physically qualified under 49 CFR 391.41; (2) that each
individual provides a copy of the ophthalmologist's or optometrist's
report to the medical examiner at the time of the annual medical
examination; and (3) that each individual provide a copy of the annual
medical certification to the employer for retention in the driver's
qualification file and retains a copy of the certification on his/her
person while driving for presentation to a duly authorized Federal,
State, or local enforcement official. Each exemption will be valid for
two years unless rescinded earlier by FMCSA. The exemption will be
rescinded if: (1) The person fails to comply with the terms and
conditions of the exemption; (2) the exemption has resulted in a lower
level of safety than was maintained before it was granted; or (3)
continuation of the exemption would not be consistent with the goals
and objectives of 49 U.S.C. 31136(e) and 31315.

Basis for Renewing Exemptions

    Under 49 U.S.C. 31315(b)(1), an exemption may be granted for no
longer than two years from its approval date and may be renewed upon
application for additional two year periods. The following group(s) of
drivers will receive renewed exemptions effective in the month of May
and are discussed below.
    As of May 7, 2016, and in accordance with 49 U.S.C. 31136(e) and
31315, the following 11 individuals have satisfied the conditions for
obtaining a renewed exemption from the vision requirements (69 FR
64806; 70 FR 2705; 71 FR 6826; 71 FR 19602; 72 FR 1054; 73 FR 11989; 74
FR 26464; 74 FR 60022; 75 FR 4623; 75 FR 13653; 76 FR 49528; 76 FR
61143; 76 FR 70212; 77 FR 543; 77 FR 5874; 77 FR 17107; 77 FR 17117; 78
FR 76707; 78 FR 77782; 79 FR 1908; 79 FR 10611; 79 FR 13085; 79 FR
14331; 79 FR 14333; 79 FR 14571; 79 FR 18391; 79 FR 18392; 79 FR 22003;
79 FR 28588; 79 FR 29498):

Stephan P. Adamczyk (ME)
Otto J. Ammer, Jr. (PA)
Alphonso A. Barco (SC)
Teddy S. Bioni (PA)
Darrell Canupp (MI)
John A. Carroll, Jr. (AL)
James A. Champion (WA)
Larry Chinn (WI)
Michael Gargano (FL)
Ronald L. Walker (FL)
Charles G. Warshun, Jr. (NY)

    The drivers were included in one of the following dockets: Docket
Nos. FMCSA-2003-16241; FMCSA-2007-28695; FMCSA-2004-19477; FMCSA-2006-
23773; FMCSA-2009-0303; FMCSA-2011-0142; FMCSA-2011-0366; FMCSA-2013-
0174; FMCSA-2014-0002; FMCSA-2014-0003; FMCSA-2014-0004. Their
exemptions are effective as of May 7, 2016 and will expire on May 7,
2018.
    As of May 11, 2016, and in accordance with 49 U.S.C. 31136(e) and
31315, the following 10 individuals have satisfied the conditions for
obtaining a renewed exemption from the vision requirements (77 FR
15184; 77 FR 27850; 79 FR 21996):

Robert L. Brauns (IA)
Bobby R. Brooks (GA)
Clifford W. Doran, Jr. (NC)
Ryan C. Dugan (NY)
Glenn C. Grimm (NJ)
Charles J. Kennedy (OH)
Richard A. Pucker (WI)
John M. Riley (AL)
Jeffery A. Sheets (AR)

Randy L. Stevens (GA)

    The drivers were included in one of the following dockets: Docket
No. FMCSA-2001-0299; FMCSA-2011-0379; FMCSA-2011-0380. Their exemptions
are effective as of May 11, 2016 and will expire on May 11, 2018.
    As of May 12, 2016, and in accordance with 49 U.S.C. 31136(e) and
31315, the following 14 individuals have satisfied the conditions for
obtaining a renewed exemption from the vision requirements (67 FR
68719; 68 FR 2629; 68 FR 74699; 69 FR 10503; 69 FR 71100; 70 FR 71884;
71 FR 4632; 71 FR 6826; 71 FR 6829; 71 FR 19602; 73 FR 5259; 73 FR
11989; 73 FR 15567; 73 FR 27015; 73 FR 76440; 75 FR 9480; 75 FR 13653;
75 FR 19674; 75 FR 22176; 77 FR 17109; 77 FR 23797; 77 FR 27845; 79 FR
23797):

Leo G. Becker (KS)
Stanley W. Davis (TX)
Ray L. Emert (PA)
John W. Forgy (ID)
Julian R. Hall (TX)
Neil W. Jennings (MO)
Mark Meacham (NC)
David A. Miller (NE)
Paul D. Schnautz (TX)
William T. Smiley (MD)
Richard M. Smith (CO)
Aaron S. Taylor (WI)
William B. Thomas (SC)
Michael J. Tisher (AK)

    The drivers were included in one of the following dockets: Docket
No. FMCSA-2002-12844; FMCSA-2003-16564; FMCSA-2005-22727; FMCSA-2006-
23773; FMCSA-2008-0021; FMCSA-2011-0380. Their exemptions are effective
as of May 12, 2016 and will expire on May 12, 2018.
    As of May 16, 2016, and in accordance with 49 U.S.C. 31136(e) and
31315, the following 36 individuals have satisfied the conditions for
obtaining a renewed exemption from the vision requirements (79 FR
14571; 79 FR 28588):

Luis A. Agudo (MN)
Dmitriy D. Bayda (WA)
Marvin J. Bensend, Jr. (MS)
Cody W. Christian (OK)
Michael T. Deaton (WI)
Billy D. Devine (WA)
James G. Donze (MO)
Jeffrey D. Duncan (IN)
Charles R. Early (IN)
Dennis A. Feather (SC)
Nicholas C. Georgen (IA)
Robert E. Johnston, Jr. (WA)
Gregory J. Kuhn (NE)
David W. Leach (IL)
Kerry M. Leeper (WA)
Jason S. Logue (GA)
David F. Martin (NJ)
Martin L. Mayes (GA)
Daniel A. McNabb, Jr. (KS)
Phillip L. Mello (CA)
Roberto C. Mendez (TX)
Robert L. Murray (IL)
Barry L. Pylant (GA)
Steve W. Quenzer (SD)
Bradley W. Reed (AL)
Erik M. Rice (TX)
Ricky D. Rostad (MN)
Tatum R. Schmidt (IA)
Harry J. Scholl (PA)
Jacob A. Shaffer (PA)
Thomas G. Smedema (WI)
James S. Smith (AR)
Thomas W. Smith (PA)
Richard H. Solum (MN)
Scott R. Sorensen (CA)
Elston L. Taylor (VA)

    The drivers were included on the following docket: Docket No.
FMCSA-2014-0003. Their exemptions are effective as of May 16, 2016 and
will expire on May 16, 2018.
    As of May 21, 2016, and in accordance with 49 U.S.C. 31136(e) and
31315, the following 8 individuals have satisfied the conditions for
obtaining a renewed exemption from the vision requirements (70 FR
48797; 70 FR 61493; 73 FR 6246; 75 FR 9480; 75 FR 14656; 75 FR 19674;
75 FR 22176; 75 FR 28684; 77 FR 15184; 77 FR 23797; 77 FR 23800; 77 FR
27850; 79 FR 22000):

David A. Brannon (FL)
Steven R. Felks (TX)
Herbert C. Hirsch (MO)
Michael D. Kilgore (TX)
Douglas L. Norman (NC)
Carroll R. Rogers (CA)
Wayne J. Savage (VA)
Marion Tutt, Jr. (GA)

    The drivers were included in one of the following dockets: Docket
No. FMCSA-2005-21711; FMCSA-2009-0011; FMCSA-2010-0050; FMCSA-2011-
0379. Their exemptions are effective as of May 21, 2016 and will expire
on May 21, 2018.
    As of May 22, 2016, and in accordance with 49 U.S.C. 31136(e) and
31315, the following 28 individuals have satisfied the conditions for
obtaining a renewed exemption from the vision requirements (79 FR
18392; 79 FR 29498):

Britton J. Anderson (KS)
James E. Baker (OH)
Aaron D. Barnett (IA)
Stanley R. Cap (SD)
Michael T. Craddock (CA)
Eric C. Dettrey (NJ)
Timothy C. Dotson (MO)
Roger L. Frazier (NC)
Danny J. Goss (MO)
James P. Griffin (WA)
Dennis P. Hart (OR)
Kyle C. Holschlag (IA)
Michael T. Huso (MN)
James D. Kessler (SD)
Robin D. Kurtz (CT)
Sherell J. Landry (TX)
Ronald N. Lindgren (MN)
Robert P. Malarkey, Sr. (NY)
Michael L. Manning (MO)
Rodney J. McMorran (IA)
John L. Meese (MO)
Thomas G. Ohlson (NY)
Robert D. Reeder (MI)
Craig Robinson (FL)
Michael E. Schlachter (WY)
Kenneth W. Sigl (WI)
Elmer F. Winters (NC)
Eugene T. Wolf (IA)

    The drivers were included in one of the following dockets: Docket
No. FMCSA-2014-0004. Their exemptions are effective as of May 22, 2016
and will expire on May 22, 2018.
    As of May 25, 2016, and in accordance with 49 U.S.C. 31136(e) and
31315, the following 18 individuals have satisfied the conditions for
obtaining a renewed exemption from the vision requirements (64 FR
68195; 65 FR 20251; 67 FR 10471; 67 FR 17102; 67 FR 19798; 69 FR 17267;
69 FR 19611; 71 FR 4194; 71 FR 13450; 71 FR 14566; 71 FR 16410; 71 FR
19604; 71 FR 30227; 73 FR 27014; 75 FR 1835; 75 FR 9480; 75 FR 9482; 75
FR 22176; 75 FR 27622; 77 FR 10604; 77 FR 17108; 77 FR 20879; 77 FR
26816; 77 FR 31427):

Dwight A. Bennett (MD)
Juan Castanon (NM)
Ronald Flanery (KY)
Joshua G. Hansen (ID)
Daniel W. Henderson (TN)
Edward W. Hosier (MO)
Craig T. Jorgensen (WI)
Jose A. Lopez (CT)
Earl E. Martin (VA)
Brian E. Monaghan (IL)
Joseph C. Powell (VA)
Albert L. Remsburg, 3rd (MD)
David L. Schachle (PA)
Dennis R. Schneider (NM)
Michael See (NY)
Steven Simone (KS)
Mark Sobczyk (WI)
Frankie A. Wilborn (GA)

    The drivers were included in one of the following dockets: Docket
No. FMCSA-1999-6480; FMCSA-2001-11426; FMCSA-2005-23099; FMCSA-2006-
24015; FMCSA-2009-0011; FMCSA-2009-0321; FMCSA-2012-0039. Their
exemptions are effective as of May 25, 2016 and will expire on May 25,
2018.
    As of May 30, 2016,, and in accordance with 49 U.S.C. 31136(e) and
31315, the following 6 individuals have satisfied the conditions for
obtaining a renewed exemption from the vision requirements (67 FR
15662; 67 FR 37907; 69 FR 26206; 71 FR 26602; 73 FR 27017; 75 FR 27621;
77 FR 27849):

Joe W. Brewer (SC)
James W. Ellis, 4th (NJ)
David A. Inman (IN)
Lawrence C. Moody (NJ)
Stanley W. Nunn (TN)
Kevin R. Stoner (PA)

    The drivers were included in one of the following dockets: Docket
No. FMCSA-2002-11714. Their exemptions are effective as of May 30, 2016
and will expire on May 30, 2018.
    Each of the 131 applicants listed in the groups above has requested
renewal of the exemption and has submitted evidence showing that the
vision in the better eye continues to meet the requirement specified at
49 CFR 391.41(b)(10) and that the vision impairment is stable. In
addition, a review of each record of safety while driving with the
respective vision deficiencies over the past two years indicates each
applicant continues to meet the vision exemption requirements.
    These factors provide an adequate basis for predicting each
driver's ability to continue to drive safely in interstate commerce.
Therefore, FMCSA concludes that extending the exemption for each
renewal applicant for a period of two years is likely to achieve a
level of safety equal to that existing without the exemption.

Request for Comments

    FMCSA will review comments received at any time concerning a
particular driver's safety record and determine if the continuation of
the exemption is consistent with the requirements at 49 U.S.C. 31136(e)
and 31315. However, FMCSA requests that interested parties with
specific data concerning the safety records of these drivers submit
comments by January 17, 2017.
    FMCSA believes that the requirements for a renewal of an exemption
under 49 U.S.C. 31136(e) and 31315 can be satisfied by initially
granting the renewal and then requesting and evaluating, if needed,
subsequent comments submitted by interested parties. As indicated
above, the Agency previously published notices of final disposition
announcing its decision to exempt these 131 individuals from the vision
requirement in 49 CFR 391.41(b)(10). The final decision to grant an
exemption to each of these individuals was made on the merits of each
case and made only after careful consideration of the comments received
to its notices of applications. The notices of applications stated in
detail the qualifications, experience, and medical condition of each
applicant for an exemption from the vision requirements. That
information is available by consulting the above cited Federal Register
publications.
    Interested parties or organizations possessing information that
would otherwise show that any, or all, of these drivers are not
currently achieving the statutory level of safety should immediately
notify FMCSA. The Agency will evaluate any adverse evidence submitted
and, if safety is being compromised or if continuation of the exemption
would not be consistent with the goals and objectives of 49 U.S.C.
31136(e) and 31315, FMCSA will take immediate steps to revoke the
exemption of a driver.

Submitting Comments

    You may submit your comments and material online or by fax, mail,
or hand delivery, but please use only one of these means. FMCSA
recommends that you include your name and a mailing address, an email
address, or a phone number in the body of your document so that FMCSA
can contact you if there are questions regarding your submission.
    To submit your comment online, go to http://www.regulations.gov and
in the search box insert the docket numbers FMCSA-1999-6480; FMCSA-
2001-11426; FMCSA-2002-11714; FMCSA-2002-12844; FMCSA-2003-16564;
FMCSA-2004-19477; FMCSA-2005-21711; FMCSA-2005-22727; FMCSA-2005-23099;
FMCSA-2006-23773; FMCSA-2006-24015; FMCSA-2008-0021; FMCSA-2009-0011;
FMCSA-2009-0303; FMCSA-2009-0321; FMCSA-2010-0050; FMCSA-2011-0142;
FMCSA-2011-0299; FMCSA-2011-0366; FMCSA-2011-0379; FMCSA-2011-0380;
FMCSA-2012-0039; FMCSA-2013-0174; FMCSA-2014-0002; FMCSA-2014-0003;
FMCSA-2014-0004 and click the search button. When the new screen
appears, click on the blue ``Comment Now!'' button on the right hand
side of the page. On the new page, enter information required including
the specific section of this document to which each comment applies,
and provide a reason for each suggestion or recommendation. If you
submit your comments by mail or hand delivery, submit them in an
unbound format, no larger than 8\1/2\ by 11 inches, suitable for
copying and electronic filing. If you submit comments by mail and would
like to know that they reached the facility, please enclose a stamped,
self-addressed postcard or envelope.
    We will consider all comments and material received during the
comment period. FMCSA may issue a final rule at any time after the
close of the comment period.

Viewing Comments and Documents

    To view comments, as well as any documents mentioned in this
preamble, go to http://www.regulations.gov and in the search box insert
the docket number FMCSA-1999-6480; FMCSA-2001-11426; FMCSA-2002-11714;
FMCSA-2002-12844; FMCSA-2003-16564; FMCSA-2004-19477; FMCSA-2005-21711;
FMCSA-2005-22727; FMCSA-2005-23099; FMCSA-2006-23773; FMCSA-2006-24015;
FMCSA-2008-0021; FMCSA-2009-0011; FMCSA-2009-0303; FMCSA-2009-0321;
FMCSA-2010-0050; FMCSA-2011-0142; FMCSA-2011-0299; FMCSA-2011-0366;
FMCSA-2011-0379; FMCSA-2011-0380; FMCSA-2012-0039; FMCSA-2013-0174;
FMCSA-2014-0002; FMCSA-2014-0003; FMCSA-2014-0004 and click ``Search.''
Next, click ``Open Docket Folder'' and you will find all documents and
comments related to this notice.

    Issued on: December 2, 2016.
Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2016-30286 Filed 12-15-16; 8:45 am]
 BILLING CODE 4910-EX-P


[Federal Register Volume 84, Number 25 (Wednesday, February 6, 2019)]
[Notices]
[Pages 2207-2208]
[FR Doc No: 2019-01152]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #2

    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER19-910-000.
    Applicants: Alabama Power Company.
    Description: Sec.  205(d) Rate Filing: APCo-Gulf TFCAT Amended and
Restated Service Agreements Filing to be effective 1/1/2019.
    Filed Date: 1/30/19.
    Accession Number: 20190130-5088.
    Comments Due: 5 p.m. ET 2/20/19.

    Docket Numbers: ER19-911-000.
    Applicants: Public Service Company of Colorado.
    Description: Sec.  205(d) Rate Filing: 2019-01-30 SPS Wholesale
Real Power Losses-Filing to be effective 4/1/2019.
    Filed Date: 1/30/19.
    Accession Number: 20190130-5089.
    Comments Due: 5 p.m. ET 2/20/19.

    Docket Numbers: ER19-912-000.
    Applicants: Georgia Power Company.
    Description: Sec.  205(d) Rate Filing: GPC-Gulf Scherer 3 TFCAT
Amended and Restated Service Agreement Filing to be effective 1/1/2019.
    Filed Date: 1/30/19.
    Accession Number: 20190130-5091.
    Comments Due: 5 p.m. ET 2/20/19.

    Docket Numbers: ER19-913-000.
    Applicants: PacifiCorp.
    Description: Tariff Cancellation: Termination of EWEB Non-Conf PTP
Agreement to be effective 2/1/2019.
    Filed Date: 1/30/19.
    Accession Number: 20190130-5123.
    Comments Due: 5 p.m. ET 2/20/19.

    Docket Numbers: ER19-914-000.
    Applicants: San Diego Gas & Electric Company.
    Description: Sec.  205(d) Rate Filing: Service Agreement No. 59
FERC Electric Tariff Volume No. 11 Mesquite Solar 5 to be effective 2/
3/2019.
    Filed Date: 1/30/19.
    Accession Number: 20190130-5124.
    Comments Due: 5 p.m. ET 2/20/19.

    Docket Numbers: ER19-915-000.
    Applicants: Midcontinent Independent System Operator, Inc.
    Description: Sec.  205(d) Rate Filing: 2019-01-30_RAN Outage
Coordination Filing to be effective 4/1/2019.
    Filed Date: 1/30/19.
    Accession Number: 20190130-5125.
    Comments Due: 5 p.m. ET 2/20/19.

    Docket Numbers: ER19-916-000.
    Applicants: Selmer Farm, LLC.
    Description: Compliance filing: Compliance Filing--Category 2
Seller to be effective 3/31/2019.
    Filed Date: 1/30/19.
    Accession Number: 20190130-5130.
    Comments Due: 5 p.m. ET 2/20/19.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.

    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: January 30, 2019.
Kimberly D. Bose,
Secretary.
[FR Doc. 2019-01152 Filed 2-5-19; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 87, Number 176 (Tuesday, September 13, 2022)]
[Notices]
[Pages 56118-56120]
[FR Doc No: 2022-19675]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-95682; File No. SR-ICEEU-2022-018]

Self-Regulatory Organizations; ICE Clear Europe Limited; Notice
of Filing and Immediate Effectiveness of Proposed Rule Change Relating
to Amendments to the ICE Clear Europe Delivery Procedures and the ICE
Clear Europe Clearing Procedures

September 7, 2022.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on August 30, 2022, ICE Clear Europe Limited (``ICE Clear Europe'' or
the ``Clearing House'') filed with the Securities and Exchange
Commission (``Commission'') the proposed rule changes described in
Items I, II, and III below, which Items have been prepared primarily by
ICE Clear Europe. ICE Clear Europe filed the proposed rule change
pursuant to Section 19(b)(3)(A) of the Act \3\ and Rule 19b-4(f)(4)(ii)
thereunder,\4\ such that the proposed rule change was immediately
effective upon filing with the Commission. The Commission is publishing
this notice to solicit comments on the proposed rule change from
interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A).
    \4\ 17 CFR 240.19b-4(f)(4)(ii).
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I. Clearing Agency's Statement of the Terms of Substance of the
Proposed Rule Change

    ICE Clear Europe Limited (``ICE Clear Europe'' or the ``Clearing
House'') proposes to amend (i) Parts C, D, F, H, K, L, AA, EE, and HH
of its Delivery Procedures (``Delivery Procedures'') and (ii) Part I of
its Clearing Procedures (``Clearing Procedures''), in each case to
implement the use of Contingent Variation Margin for certain UK and
European energy futures contracts.

II. Clearing Agency's Statement of the Purpose of, and Statutory Basis
for, the Proposed Rule Change

    In its filing with the Commission, ICE Clear Europe included
statements concerning the purpose of and basis for the proposed rule
change and discussed any comments it received on the proposed rule
change. The text of these statements may be examined at the places
specified in Item IV below. ICE Clear Europe has prepared summaries,
set forth in sections (A), (B), and (C) below, of the most significant
aspects of such statements.

(A) Clearing Agency's Statement of the Purpose of, and Statutory Basis
for, the Proposed Rule Change

(a) Purpose
Background
    The amendments are intended to extend the Clearing House's use of
Contingent Variation Margin (``CVM'') requirements during the tender or
delivery period to certain additional UK and European natural gas and
electricity futures contracts. Under the existing Rules and Procedures
(including paragraph 4.6 of the Clearing Procedures), CVM can be
imposed by the Clearing House on specified F&O Contracts to account for
the difference, during the delivery period, between the final
settlement price for the relevant contract (typically established on
the last trading day of the contract, before the commencement of the
delivery period) and the price of the relevant contract for the next
contract month. CVM is intended to provide additional protection to the
Clearing House against potential exposure to Clearing Member default
from movements in the market price of the underlying commodity during
the delivery period. CVM is collected by the Clearing House from the
applicable Clearing Members but not paid out to the opposite Clearing
Members, although the opposite Clearing Member may apply the amount as
a credit against other margin requirements.
    ICE Clear Europe is proposing to amend the Clearing Procedures and
the Delivery Procedures chapters for the relevant Contracts in order to
implement the extension to specified UK and European energy futures
contracts.
Clearing Procedures
    Paragraph 4.6 of the Clearing Procedures would be updated to remove
the two listed examples of contracts for which CVM would be required.
Given the Clearing House's proposed extension of the use of CVM, the
examples would be incomplete and are in any event unnecessary.
Additionally, the amendments would make a clarification that Clearing
Members will not receive payment of CVM in cash (as opposed to
referring to repayment) but instead may credit CVM against other margin
requirements, as discussed above. Paragraph 4.7, which described a
prior contingent credit approach for sellers under natural gas and
electricity futures, would be removed as it will be superseded by the
extension of CVM to such contracts.
Delivery Procedures
    ICE Clear Europe is proposing to amend Parts C, D, F, H, K, L, AA,
EE, and HH of its Delivery Procedures to implement CVM for physically-
settled monthly European and UK electricity and natural gas futures
contracts.
    The delivery timetable for routine deliveries of ICE UK Electricity
Futures in Part C of the Delivery Procedures would be updated to
provide that on the Delivery Day of such contract the Clearing House
will apply CVM to the Buyer's and the Seller's remaining units of the
underlying to be delivered. The amendments would further provide on the
Business Day following the Delivery Day, the Clearing House will
continue to apply CVM to the Buyer's and Seller's remaining units of
the underlying to be delivered. The same updates would be made to the
delivery timetable for routine deliveries of each of (i) ICE Futures UK
Natural Gas Futures (Part D of the Delivery Procedures), (ii) ICE Endex
TTF Natural Gas Futures (Part F of the Delivery Procedures), (iii) ICE
Endex German THE Natural Gas Futures (Part H of the Delivery
Procedures), (iv) ICE Endex Dutch Power Futures (Part K of the Delivery
Procedures), (v) ICE Endex Belgian Power Base Load Futures (Part L of
the Delivery Procedures), and (vi) ICE Endex French PEG Natural Gas
Futures (Part HH of the Delivery Procedures). In respect of the
delivery timetable for routine delivery of ICE Endex PSV Natural Gas
Futures (Part AA of the Delivery Procedures) and ICE Endex VTP Natural
Gas Futures (Part EE of the Delivery Procedures), similar updates would
be made taking into account the delivery characteristics of those
contracts: each such timetable would provide that on the first Business
Day immediately preceding the first day of the month in which the
Delivery Day specified in the relevant contract commenced, the Clearing
House will apply CVM to the Buyer's and the Seller's remaining natural
gas units. The amendments would further provide that on the Business
Day following the Delivery Day, the Clearing House will continue to
apply CVM to the Buyer's and Seller's remaining natural gas units.
    The amendments would make certain other clarifications updates to
the Delivery Procedures unrelated to the

implementation of CVM. Specifically, references to ICE Futures UK
Natural Gas (EUR/MWh) Futures Contracts in Part D of the Delivery
Procedures would be removed as such contracts are no longer traded. In
Part F of the Delivery Procedures (ICE Endex TTF Natural Gas Futures),
references to weekly contracts (and related defined terms such as
``Delivery Week'' and ``W+'' and ``W-'' would be removed as no such TTF
natural gas contracts of this type are traded. The remaining provisions
would apply to the continuing monthly contracts (with some references
to ``monthly'' removed as no longer necessary to distinguish from
weekly contracts). In Part K of the Delivery Procedures (ICE Endex Base
Load Futures), references to the ICE Endex Dutch Power Base Load Week
Futures and related references to weekly contracts and related defined
terms are being removed since such weekly contract will no longer be
listed for trading. The remaining provisions would apply to the
continuing monthly contracts (with some references to ``monthly''
removed as no longer necessary to distinguish from weekly contracts).
In Part HH of the Delivery Procedures (ICE Endex PEG Natural Gas
Futures) references to the applicable ICE Endex confirmation reports
are being corrected.
(b) Statutory Basis
    ICE Clear Europe believes that the proposed amendments to the
Delivery Procedures and the Clearing Procedures are consistent with the
requirements of Section 17A of the Act \5\ and the regulations
thereunder applicable to it. In particular, Section 17A(b)(3)(F) of the
Act \6\ requires, among other things, that the rules of a clearing
agency be designed to promote the prompt and accurate clearance and
settlement of securities transactions and, to the extent applicable,
derivative agreements, contracts, and transactions, the safeguarding of
securities and funds in the custody or control of the clearing agency
or for which it is responsible, and the protection of investors and the
public interest. The proposed changes are intended to apply CVM to
certain additional UK and European electricity and natural gas futures
contracts to enhance the protections for the Clearing House against the
risk of market movements in the underlying commodity during the
delivery period. The amendments to the Delivery Procedures are designed
to add applicable references to CVM requirements in respect of the
routine delivery of certain physically-settled European and UK Natural
Gas futures contracts in order to reflect the Clearing House's
application of CVM. The changes to the Clearing Procedures are intended
to align with such updates to the Delivery Procedures. Certain
additional updates and clarifications would be made to the Delivery
Procedures. The amendments would not otherwise affect the manner in
which such contracts are cleared and settled. As a result, in ICE Clear
Europe's view, the amendments would be consistent with the prompt and
accurate clearance and settlement of the contracts, the safeguarding of
funds or securities in the custody or control of the clearing agency or
for which it is responsible, and the protection of investors and the
public interest, consistent with the requirements of Section
17A(b)(3)(F) of the Act.\7\
---------------------------------------------------------------------------

    \5\ 15 U.S.C. 78q-1.
    \6\ 15 U.S.C. 78q-1(b)(3)(F).
    \7\ 15 U.S.C. 78q-1(b)(3)(F).
---------------------------------------------------------------------------

    Rule 17Ad-22(e)(6) provides that ``[e]ach covered clearing agency
shall establish, implement, maintain and enforce written policies and
procedures reasonable designed to, as applicable [. . .] cover, if the
covered clearing agency provides central counterparty services, its
credit exposures to its participants by establishing a risk-based
margin system that, at a minimum (i) considers, and produces margin
levels commensurate with the risks and particular attributes of each
relevant product, portfolio and market. . . .''.\8\ As discussed above,
ICE Clear Europe has determined to apply CVM to certain additional UK
and European natural gas and electricity futures contracts to address
the particular risks faced by the Clearing House with respect to such
contracts as a result of price movements during the delivery period. As
a result, in ICE Clear Europe's view, the amendments are consistent
with the requirements of Rule 17Ad-22(e)(6).\9\
---------------------------------------------------------------------------

    \8\ 17 CFR 240.17Ad-22(e)(6).
    \9\ 17 CFR 240.17Ad-22(e)(6).
---------------------------------------------------------------------------

    In addition, Rule 17Ad-22(e)(10) \10\ provides that ``[e]ach
covered clearing agency shall establish, implement, maintain and
enforce written policies and procedures reasonable designed to, as
applicable [. . .] establish and maintain transparent written standards
that state its obligations with respect to the delivery of physical
instruments, and establish and maintain operational practices that
identify, monitor and manage the risks associated with such physical
deliveries.'' The proposed changes to the Delivery Procedures are
designed to amend delivery specifications in respect of the routine
delivery of certain physically-settled European and UK Natural Gas
futures contracts to reflect the application of CVM. Clearance of such
contracts would not otherwise be affected. As amended, the Delivery
Procedures thus appropriately state the role and responsibilities of
the Clearing House and Clearing Members with respect to physical
delivery. As a result, ICE Clear Europe believes the amendments are
consistent with the requirements of Rule 17Ad-22(e)(10).\11\
---------------------------------------------------------------------------

    \10\ 17 CFR 240.17Ad-22(e)(10).
    \11\ 17 CFR 240.17Ad-22(e)(10).
---------------------------------------------------------------------------

(B) Clearing Agency's Statement on Burden on Competition

    ICE Clear Europe does not believe the proposed amendments would
have any impact, or impose any burden, on competition not necessary or
appropriate in furtherance of the purposes of the Act. The proposed
amendments to the Delivery Procedures are intended to implement the
Clearing House's application of CVM in respect of certain physically-
settled European and UK electricity and natural gas futures contracts.
The imposition of CVM may impose certain costs on market participants
trading such contracts, as they may be required to provide CVM amounts
to the Clearing House during the delivery period. ICE Clear Europe
believes that such costs are appropriate, however, to account for the
risks to the Clearing House from market movements during the delivery
period, and reflect the particular positions of the market participant
that have gone to delivery. The CVM requirements will apply in the same
way to all similarly situated market participants. ICE Clear Europe
does not believe the amendments would otherwise materially affect the
cost of clearing, adversely affect competition among Clearing Members,
adversely affect access to clearing in the relevant contracts for
Clearing Members or their customers, or otherwise adversely affect
competition in clearing services. Accordingly, ICE Clear Europe does
not believe that the amendments would impose any impact or burden on
competition that is not appropriate in furtherance of the purpose of
the Act.

(C) Clearing Agency's Statement on Comments on the Proposed Rule Change
Received From Members, Participants or Others

    Written comments relating to the proposed amendment has not been
solicited or received by ICE Clear Europe. ICE Clear Europe will notify
the Commission of any comments received

with respect to the proposed rule change.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A) of the Act \12\ and paragraph (f) of Rule 19b-4 \13\
thereunder. At any time within 60 days of the filing of the proposed
rule change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act.
---------------------------------------------------------------------------

    \12\ 15 U.S.C. 78s(b)(3)(A).
    \13\ 17 CFR 240.19b-4(f).
---------------------------------------------------------------------------

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml) or
     Send an email to [email protected]. Please include
File Number SR-ICEEU-2022-018 on the subject line.

Paper Comments

     Send paper comments in triplicate to Secretary, Securities
and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.

All submissions should refer to File Number SR-ICEEU-2022-018. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (http://www.sec.gov/rules/sro.shtml).
Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for website viewing and printing in
the Commission's Public Reference Room, 100 F Street NE, Washington, DC
20549, on official business days between the hours of 10:00 a.m. and
3:00 p.m. Copies of such filings will also be available for inspection
and copying at the principal office of ICE Clear Europe and on ICE
Clear Europe's website at https://www.theice.com/clear-europe/regulation.
    All comments received will be posted without change. Persons
submitting comments are cautioned that we do not redact or edit
personal identifying information from comment submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-ICEEU-2022-018 and should be
submitted on or before October 4, 2022.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\14\
---------------------------------------------------------------------------

    \14\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

J. Matthew DeLesDernier,
Deputy Secretary.
[FR Doc. 2022-19675 Filed 9-12-22; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 87, Number 69 (Monday, April 11, 2022)]
[Notices]
[Pages 21127-21129]
[FR Doc No: 2022-07690]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-D-3049]

E8(R1) General Considerations for Clinical Studies; International
Council for Harmonisation; Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance for industry entitled ``E8(R1)
General Considerations for Clinical Studies.'' The guidance was
prepared under the auspices of the International Council for
Harmonisation (ICH), formerly the International Conference on
Harmonisation. The guidance describes internationally accepted
principles and practices for the design and conduct of clinical studies
of drug and biological products. In addition, the guidance provides an
overview of the types of clinical studies that may be performed and
data sources used during the product's life cycle. The guidance is
intended to promote the quality of the studies submitted to regulatory
authorities, while allowing for flexibility. This guidance revises the
guidance for industry ``E8 General Considerations for Clinical Trials''
issued in December 1997.

DATES: The announcement of the guidance is published in the Federal
Register on April 11, 2022.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2019-D-3049 for ``E8(R1) General Considerations for Clinical
Studies.'' Received comments will be placed in the docket and, except
for those submitted as ``Confidential Submissions,'' publicly viewable
at https://www.regulations.gov or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked

as ``confidential'' will not be disclosed except in accordance with 21
CFR 10.20 and other applicable disclosure law. For more information
about FDA's posting of comments to public dockets, see 80 FR 56469,
September 18, 2015, or access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of this guidance to the
Division of Drug Information, Center for Drug Evaluation and Research,
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale
Building, 4th Floor, Silver Spring, MD 20993-0002, or the Office of
Communication, Outreach and Development, Center for Biologics
Evaluation and Research (CBER), Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your requests. The guidance may also be obtained by mail by calling
CBER at 1-800-835-4709 or<PHONE_NUMBER>. See the SUPPLEMENTARY
INFORMATION section for electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Regarding the guidance: Mark Levenson,
Center for Drug Evaluation and Research, Food and Drug Administration,
Bldg. 21, Rm. 4626, Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
[email protected]; or Stephen Ripley, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-
402-7911.
    Regarding the ICH: Jill Adleberg, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6364, Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a final guidance for industry
entitled ``E8(R1) General Considerations for Clinical Studies''. The
guidance was prepared under the auspices of ICH. ICH has the mission of
achieving greater regulatory harmonization worldwide to ensure that
safe, effective, high-quality medicines are developed, registered, and
maintained in the most resource-efficient manner.
    By harmonizing the regulatory requirements in regions around the
world, ICH guidelines have substantially reduced duplicative clinical
studies, prevented unnecessary animal studies,\1\ standardized the
reporting of important safety information, standardized marketing
application submissions, and made many other improvements in the
quality of global drug development and manufacturing and the products
available to patients.
---------------------------------------------------------------------------

    \1\ We support the principles of the ``3Rs,'' to reduce, refine,
and replace animal use in testing when feasible. We encourage
sponsors to consult with us if it they wish to use a non-animal
testing method they believe is suitable, adequate, validated, and
feasible. We will consider if such an alternative method could be
assessed for equivalency to an animal test method.
---------------------------------------------------------------------------

    The six Founding Members of the ICH are FDA; the Pharmaceutical
Research and Manufacturers of America; the European Commission; the
European Federation of Pharmaceutical Industries Associations; the
Japanese Ministry of Health, Labour, and Welfare; and the Japanese
Pharmaceutical Manufacturers Association. The Standing Members of the
ICH Association include Health Canada and Swissmedic. Additionally, the
Membership of ICH has expanded to include other regulatory authorities
and industry associations from around the world (refer to https://www.ich.org/).
    ICH works by involving technical experts from both regulators and
industry parties in detailed technical harmonization work and the
application of a science-based approach to harmonization through a
consensus-driven process that results in the development of ICH
guidelines. The regulators around the world are committed to
consistently adopting these consensus-based guidelines, realizing the
benefits for patients and for industry.
    As a Founding Regulatory Member of ICH, FDA plays a major role in
the development of each of the ICH guidelines, which FDA then adopts
and issues as guidance for industry. FDA's guidance documents do not
establish legally enforceable responsibilities. Instead, they describe
the Agency's current thinking on a topic and should be viewed only as
recommendations, unless specific regulatory or statutory requirements
are cited.
    In the Federal Register of August 1, 2019 (84 FR 37649), FDA
published a notice announcing the availability of a draft guidance
entitled ``E8(R1) General Considerations for Clinical Studies.'' The
notice gave interested persons an opportunity to submit comments by
September 30, 2019. After consideration of the comments received and
revisions to the guideline, a final draft of the guideline was
submitted to the ICH Assembly and endorsed by the regulatory agencies
in October 2021.
    This guidance finalizes the draft guidance issued on August 1,
2019. The revised final guidance describes internationally accepted
principles and practices in the design and conduct of clinical studies
of drug and biological products. Changes from the 2019 draft guidance
to the final guidance include a reduced emphasis on distinct phases of
clinical development, the addition of examples of novel studies, and
amendments to appendices. The original ICH guidance ``E8 General
Considerations for Clinical Trials,'' that was issued in 1997 has not
undergone revision previously. Since the 1997 guidance was issued,
clinical trial design and conduct have become more complex, impacting
the time and feasibility of developing drugs. In response, the revised
guidance directly addresses study quality to ensure the protection of
study participants and the generation of reliable and meaningful
results, while promoting study efficiency. The ICH E8(R1) guidance
focuses on the identification of factors that are critical to the study
quality and the management of risks to those factors. Additionally, a
wider range of study designs and data sources play an increasingly
important role in drug development and are not adequately addressed in
the original ICH E8 guidance. Hence, the revised final guidance
addresses a broad range of study designs and data sources. The revised
final guidance also provides updated cross-referencing to other
relevant ICH guidances that inform the design, planning, and conduct of
clinical research, without reproducing the detailed material found in
those guidances.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on ``E8(R1) General Considerations for Clinical
Studies.'' It does not establish any rights for any person and is not
binding on FDA or the

public. You can use an alternative approach if it satisfies the
requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information for investigational new drug applications under have
been approved under OMB control number 0910-0014; the collections of
information for review of new drug applications in have been approved
under OMB control number 0910-0001; and the collections of information
for review of biologic licensing applications in have been approved
under OMB control number 0910-0338.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at
https://www.regulations.gov, https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances.

    Dated: April 5, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-07690 Filed 4-8-22; 8:45 am]
BILLING CODE 4164-01-P