[Federal Register Volume 79, Number 135 (Tuesday, July 15, 2014)]
[Rules and Regulations]
[Pages 41098-41101]
[FR Doc No: 2014-15800]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2013-0973; Directorate Identifier 2013-NM-139-AD;
Amendment 39-17893; AD 2014-13-17]
RIN 2120-AA64

Airworthiness Directives; Airbus Airplanes

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Final rule.

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SUMMARY: We are adopting a new airworthiness directive (AD) for all
Airbus Model A300 series airplanes; Airbus Model A300 B4-600, B4-600R,
and F4-600R series airplanes, and Model A300 C4-605R Variant F
airplanes (collectively called Model A300-600 series airplanes); and
Model A310 series airplanes. This AD was prompted by reports of
failures of the right inner tank fuel pump. This AD requires repetitive
functional tests of the circuit breakers for the fuel pump power
supply, and replacement of certain circuit breakers. We are issuing
this AD to detect and correct failure of the circuit breakers for the
fuel pump power supply, which could result in a fuel pump overheating,
leading to a fuel tank explosion.

DATES: This AD becomes effective August 19, 2014.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of August 19,
2014.

ADDRESSES: You may examine the AD docket on the Internet at http://www.regulations.gov/#!docketDetail;D=FAA-2013-0973; or in person at the
Docket Management Facility, U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC.
    For service information identified in this AD, contact Airbus SAS,
Airworthiness Office--EAW, 1 Rond Point Maurice Bellonte, 31707 Blagnac
Cedex, France; telephone +33 5 61 93 36 96; fax +33 5 61 93 44 51;
email<EMAIL_ADDRESS>Internet http://www.airbus.com.
You may view this referenced service information at the FAA, Transport
Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For information
on the availability of this material at the FAA, call<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Dan Rodina, Aerospace Engineer,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
1601 Lind Avenue SW., Renton, WA 98057-3356; telephone<PHONE_NUMBER>;
fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 by adding an AD that would apply to all Airbus Model A300
series airplanes; Airbus Model A300 B4-600, B4-600R, and F4-600R series
airplanes, and Model A300 C4-605R Variant F airplanes (collectively
called Model A300-600 series airplanes); and Model A310 series
airplanes. The NPRM published in the Federal Register on November 22,
2013 (78 FR 70003).
    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Community, has issued EASA
Airworthiness Directive 2013-0163, dated July 24, 2013 (referred to
after this as the Mandatory Continuing Airworthiness Information, or
``the MCAI''), to correct an unsafe condition for the specified
products. The MCAI states:

    Two successive failures have been reported of a Right Hand
1 inner tank fuel pump, Part Number 2052Cxx series (with
placeholder ``xx'' indicating numerals). The fix consisted in the
replacement of the pump, the associated circuit breaker and the AC
[alternating current] bus load relay.
    Investigations determined that, in case of loss of one phase on
the pump supply and the associated circuit breaker failing to trip,
the fuel pump thermal fuses may not operate as quickly as expected.
    This condition, if not detected and corrected, would result in
an overheat condition of the fuel pump in excess of 200 [deg]C and
could lead to a fuel tank explosion.
    To address this potential unsafe condition, Airbus issued Alert
Operator Transmission (AOT) A28W002-13 providing instructions for a
functional test of circuit breakers and corrective action.
    For the reasons described above, as a temporary measure until
further notice, this [EASA] AD mandates functional tests of the
affected fuel pump power supply circuit breakers, and, depending on
findings, replacement of circuit breakers.
    This [EASA] AD will be followed by further [EASA] AD action.

    You may examine the MCAI in the AD docket on the Internet at http://www.regulations.gov/#!documentDetail;D=FAA-2013-0973-0002.

Comments

    We gave the public the opportunity to participate in developing
this AD. We received no comments on the NPRM (78 FR 70003, November 22,
2013) or on the determination of the cost to the public.

``Contacting the Manufacturer'' Paragraph in This AD

    Since late 2006, we have included a standard paragraph titled
``Airworthy Product'' in all MCAI ADs in which the FAA develops an AD
based on a foreign authority's AD.
    The MCAI or referenced service information in an FAA AD often
directs the owner/operator to contact the manufacturer for corrective
actions, such as a repair. Briefly, the Airworthy Product paragraph
allowed owners/operators to use corrective actions provided by the
manufacturer if those actions were FAA-approved. In addition, the
paragraph stated that any actions approved by the State of Design
Authority (or its delegated agent) are considered to be FAA-approved.
    In the NPRM (78 FR 70003, November 22, 2013), we proposed to
prevent the use of repairs that were not specifically developed to
correct the unsafe condition, by requiring that the repair approval
provided by the State of Design Authority or its delegated agent
specifically refer to this FAA AD. This change was intended to clarify
the method of compliance and to provide operators with better
visibility of repairs that are specifically developed and approved to
correct the unsafe condition. In addition, we proposed to change the
phrase ``its delegated agent'' to include a design approval holder
(DAH) with State of Design Authority design organization approval
(DOA), as applicable, to refer to a DAH authorized

to approve required repairs for the proposed AD.
    No comments were provided to the NPRM (78 FR 70003, November 22,
2013) about these proposed changes. However, a comment was provided for
another NPRM, Directorate Identifier 2012-NM-101-AD (78 FR 78285,
December 26, 2013). The commenter stated the following: ``The proposed
wording, being specific to repairs, eliminates the interpretation that
Airbus messages are acceptable for approving minor deviations
(corrective actions) needed during accomplishment of an AD mandated
Airbus service bulletin.''
    This comment has made the FAA aware that some operators have
misunderstood or misinterpreted the Airworthy Product paragraph to
allow the owner/operator to use messages provided by the manufacturer
as approval of deviations during the accomplishment of an AD-mandated
action. The Airworthy Product paragraph does not approve messages or
other information provided by the manufacturer for deviations to the
requirements of the AD-mandated actions. The Airworthy Product
paragraph only addresses the requirement to contact the manufacturer
for corrective actions for the identified unsafe condition and does not
cover deviations from other AD requirements. However, deviations to AD-
required actions are addressed in 14 CFR 39.17, and anyone may request
the approval for an alternative method of compliance to the AD-required
actions using the procedures found in 14 CFR 39.19.
    To address this misunderstanding and misinterpretation of the
Airworthy Product paragraph, we have changed that paragraph and
retitled it ``Contacting the Manufacturer.'' This paragraph now
clarifies that for any requirement in this AD to obtain corrective
actions from a manufacturer, the action must be accomplished using a
method approved by the FAA, the European Aviation Safety Agency (EASA),
or Airbus's EASA DOA. Where necessary throughout this AD, we also
replaced any reference to approvals of corrective actions with a
reference to the Contacting the Manufacturer paragraph.
    The Contacting the Manufacturer paragraph also clarifies that, if
approved by the DOA, the approval must include the DOA-authorized
signature. The DOA signature indicates that the data and information
contained in the document are EASA-approved, which is also FAA-
approved. Messages and other information provided by the manufacturer
that do not contain the DOA-authorized signature approval are not EASA-
approved, unless EASA directly approves the manufacturer's message or
other information.
    This clarification does not remove flexibility previously afforded
by the Airworthy Product paragraph. Consistent with long-standing FAA
policy, such flexibility was never intended for required actions. This
is also consistent with the recommendation of the Airworthiness
Directive Implementation Aviation Rulemaking Committee to increase
flexibility in complying with ADs by identifying those actions in
manufacturers' service instructions that are ``Required for
Compliance'' with ADs. We continue to work with manufacturers to
implement this recommendation. But once we determine that an action is
required, any deviation from the requirement must be approved as an
alternative method of compliance.
    Other commenters to the NPRM discussed previously, Directorate
Identifier 2012-NM-101-AD (78 FR 78285, December 26, 2013), pointed out
that in many cases the foreign manufacturer's service bulletin and the
foreign authority's MCAI might have been issued some time before the
FAA AD. Therefore, the DOA might have provided U.S. operators with an
approved repair, developed with full awareness of the unsafe condition,
before the FAA AD is issued. Under these circumstances, to comply with
the FAA AD, the operator would be required to go back to the
manufacturer's DOA and obtain a new approval document, adding time and
expense to the compliance process with no safety benefit.
    Based on these comments, we removed the requirement that the DAH-
provided repair specifically refer to this AD. Before adopting such a
requirement, the FAA will coordinate with affected DAHs and verify they
are prepared to implement means to ensure that their repair approvals
consider the unsafe condition addressed in this AD. Any such
requirements will be adopted through the normal AD rulemaking process,
including notice-and-comment procedures, when appropriate. We also have
decided not to include a generic reference to either the ``delegated
agent'' or ``DAH with State of Design Authority design organization
approval,'' but instead we have provided the specific delegation
approval granted by the State of Design Authority for the DAH in the
Contacting the Manufacturer paragraph of this AD.

Conclusion

    We reviewed the relevant data and determined that air safety and
the public interest require adopting this AD with the changes described
previously and minor editorial changes. We have determined that these
minor changes:
     Are consistent with the intent that was proposed in the
NPRM (78 FR 70003, November 22, 2013) for correcting the unsafe
condition; and
     Do not add any additional burden upon the public than was
already proposed in the NPRM (78 FR 70003, November 22, 2013).
    We also determined that these changes will not increase the
economic burden on any operator or increase the scope of this AD.

Costs of Compliance

    We estimate that this AD affects 156 airplanes of U.S. registry.
    We also estimate that it will take about 1 work-hour per product to
comply with the basic requirements of this AD. The average labor rate
is $85 per work-hour. Required parts will cost about $0 per product.
Based on these figures, we estimate the cost of this AD on U.S.
operators to be $85 per test, or $13,260 per test for U.S.-registered
airplanes.
    We have received no definitive data that would enable us to provide
cost estimates for the on-condition actions specified in this AD.

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 AD will not have federalism implications
under Executive Order 13132. This AD will not have a substantial direct
effect on the States, on the relationship between the national
government and the States, or on the distribution of power and

responsibilities among the various levels of government.
    For the reasons discussed above, I certify that this AD:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979);
    3. Will not affect intrastate aviation in Alaska; and
    4. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov/#!docketDetail;D=FAA-2013-0973; or in person at the
Docket Management Facility between 9 a.m. and 5 p.m., Monday through
Friday, except Federal holidays. The AD docket contains this AD, the
regulatory evaluation, any comments received, and other information.
The street address for the Docket Operations office (telephone 800-647-
5527) is in the ADDRESSES section.

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

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

Sec.  39.13  [Amended]

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

2014-13-17 Airbus: Amendment 39-17893. Docket No. FAA-2013-0973;
Directorate Identifier 2013-NM-139-AD.

(a) Effective Date

    This AD becomes effective August 19, 2014.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to the Airbus airplanes specified in paragraphs
(c)(1), (c)(2), (c)(3), (c)(4), (c)(5), and (c)(6) of this AD;
certificated in any category; all serial numbers.
    (1) Model A300 B2-1A, B2-1C, B2K-3C, B2-203, B4-2C, B4-103, and
B4-203 airplanes.
    (2) Model A300 B4-601, B4-603, B4-620, and B4-622 airplanes.
    (3) Model A300 B4-605R and B4-622R airplanes.
    (4) Model A300 F4-605R and F4-622R airplanes.
    (5) Model A300 C4-605R Variant F airplanes.
    (6) Model A310-203, -204, -221, -222, -304, -322, -324, and -325
airplanes.

(d) Subject

    Air Transport Association (ATA) of America Code 28, Fuel.

(e) Reason

    This AD was prompted by reports of failures of the right inner
tank fuel pump. We are issuing this AD to detect and correct failure
of the circuit breakers for the fuel pump power supply, which could
result in a fuel pump overheating, leading to a fuel tank explosion.

(f) Compliance

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

(g) Repetitive Functional Tests of Circuit Breakers

    (1) Within 6 months or 500 flight hours after the effective date
of this AD, whichever occurs first: Do a functional test of the
circuit breakers for the fuel pump power supply, as identified in
paragraphs (g)(1)(i), (g)(1)(ii), and (g)(1)(iii) of this AD, as
applicable, in accordance with Airbus Alert Operators Transmission
A28W002-13, dated July 23, 2013. Repeat the functional test
thereafter at intervals not to exceed 6 months or 500 flight hours,
whichever occurs first.
    (i) For Airbus Model A300 B2-1A, B2-1C, B2K-3C, and B2-203
airplanes: Inner and outer pump, No. 1 and No. 2 left-hand (LH) side
and right-hand (RH) side.
    (ii) For Airbus Model A300 B4-2C, B4-103, B4-203, B4-601, B4-
603, B4-620, and B4-622 airplanes; and A310-203, -204, -221, and -
222 airplanes:
    (A) Inner and outer pump, No. 1 and No. 2, LH and RH; and
    (B) Center pump, LH and RH.
    (iii) For Airbus Model A300 B4-605R, B4-622R, F4-605R, F4-622R,
and C4-605R Variant F airplanes; and Model A310-304, -322, -324, and
-325 airplanes:
    (A) Inner and outer pump, No. 1 and No. 2, LH and RH;
    (B) Center pump, LH and RH; and
    (C) Trim tank pump No. 1 and No. 2.
    (2) If, during any functional test required by paragraph (g)(1)
of this AD, any circuit breaker fails any functional test, or any
circuit breaker is found to be stuck closed, before further flight,
replace the affected circuit breaker with a serviceable part, in
accordance with Airbus Alert Operators Transmission A28W002-13,
dated July 23, 2013.
    (3) The replacement of one or more circuit breakers as required
by paragraph (g)(2) of this AD does not terminate the repetitive
functional tests required by paragraph (g)(1) of this AD.

(h) Other FAA AD Provisions

    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. In accordance with 14 CFR
39.19, send your request to your principal inspector or local Flight
Standards District Office, as appropriate. If sending information
directly to the International Branch, send it to ATTN: Dan Rodina,
Aerospace Engineer, International Branch, ANM-116, Transport
Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton, WA 98057-
3356; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>. Information may be
emailed to<EMAIL_ADDRESS>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. The
AMOC approval letter must specifically reference this AD.
    (2) Contacting the Manufacturer: For any requirement in this AD
to obtain corrective actions from a manufacturer, the action must be
accomplished using a method approved by the Manager, International
Branch, ANM-116, Transport Airplane Directorate, FAA; or the
European Aviation Safety Agency (EASA); or Airbus's EASA Design
Organization Approval (DOA). If approved by the DOA, the approval
must include the DOA-authorized signature.

(i) Related Information

    Refer to Mandatory Continuing Airworthiness Information (MCAI)
European Aviation Safety Agency Airworthiness Directive 2013-0163,
dated July 24, 2013, for related information. This MCAI may be found
in the AD docket on the Internet at http://www.regulations.gov/#!documentDetail;D=FAA-2013-0973-0002.

(j) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless this AD specifies otherwise.
    (i) Airbus Alert Operators Transmission A28W002-13, dated July
23, 2013.
    (ii) Reserved.
    (3) For service information identified in this AD, contact
Airbus SAS, Airworthiness Office--EAW, 1 Rond Point Maurice
Bellonte, 31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96;
fax +33 5 61 93 44 51; email<EMAIL_ADDRESS>
Internet http://www.airbus.com. You may view this referenced service
information at the FAA, Transport Airplane Directorate, 1601 Lind
Avenue SW., Renton, WA. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>.

    (4) You may view this service information at the FAA, Transport
Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For
information on the availability of this material at the FAA, call
425-227-1221.
    (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, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Renton, Washington, on June 25, 2014.
Jeffrey E. Duven,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2014-15800 Filed 7-14-14; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 85, Number 9 (Tuesday, January 14, 2020)]
[Rules and Regulations]
[Pages 2018-2020]
[FR Doc No: 2020-00295]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 890

[Docket No. FDA-2019-P-3347]

Medical Devices; Exemption From Premarket Notification; Class II
Devices; Powered Wheeled Stretcher

AGENCY: Food and Drug Administration, HHS.

ACTION: Final amendment; final order.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is publishing
an order granting a petition requesting exemption from premarket
notification (510(k)) requirements for powered wheeled stretchers
(product code INK). These devices are battery-powered tables with
wheels that are intended for medical purposes for use by patients who
are unable to propel themselves independently and who must maintain a
prone or supine position for prolonged periods because of skin ulcers
or contractures (muscle contractions). This order exempts powered
wheeled stretchers, class II devices, from 510(k) requirements, subject
to certain conditions for exemption. This exemption from 510(k)
requirements is immediately in effect for powered wheeled stretchers.
FDA is publishing this order in accordance with the section of the
Federal Food, Drug, and Cosmetic Act (FD&C Act) permitting the
exemption of a device from the requirement to submit a 510(k).

DATES: This order is effective January 14, 2020.

FOR FURTHER INFORMATION CONTACT: Eric Franca, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1655, Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Statutory Background

    Section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and its
implementing regulations in part 807, subpart E (21 CFR part 807,
subpart E) require persons who propose to begin the introduction or
delivery for introduction into interstate commerce for commercial
distribution of a device intended for human use to submit a 510(k) to
FDA. The device may not be marketed until FDA finds it ``substantially
equivalent'' within the meaning of section 513(i) of the FD&C Act (21
U.S.C. 360c(i)) to a legally marketed device that does not require
premarket approval.
    On November 21, 1997, the President signed into law the Food and
Drug Administration Modernization Act of 1997 (Pub. L. 105-115),
section 206 of which added section 510(m) to the FD&C Act, which was
amended on December 13, 2016, by the 21st Century Cures Act (Pub. L.
114-255). Section 510(m)(1) of the FD&C Act requires FDA to publish in
the Federal Register a notice that contains a list of each type of
class II device that does not require a report under section 510(k) of
the FD&C Act to provide reasonable assurance of safety and
effectiveness of the device. Section 510(m) of the FD&C Act further
provides that a 510(k) will no longer be required for these devices
upon the date of publication of the list in the Federal Register. FDA
published that list in the Federal Register of January 21, 1998 (63 FR
3142).
    Section 510(m)(2) of the FD&C Act provides that FDA may exempt a
device from 510(k) requirements on its own initiative, or upon petition
of an interested person, if FDA determines that a 510(k) is not
necessary to assure the safety and effectiveness of the device. This
section requires FDA to publish in the Federal Register a notice of
intent to exempt a device, or of the petition, and to provide a 60-
calendar-day period for public comment. Within 120 days after the
issuance of the notice, FDA shall publish an order in the Federal
Register setting forth the final determination regarding the exemption
of the device that was the subject of the notice. If FDA fails to
respond to a petition under this section within 180 days of receiving
it, the petition shall be deemed granted.

II. Criteria for Exemption

    There are a number of factors FDA may consider to determine whether
a 510(k) is necessary to assure the safety and effectiveness of a class
II device. These factors are discussed in the guidance that the Agency
issued on

February 19, 1998, entitled ``Procedures for Class II Device Exemptions
from Premarket Notification'' (Class II 510(k) Exemption Guidance).
That guidance can be obtained through the internet at https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM080199.pdf or by sending an email request to<EMAIL_ADDRESS>to receive a copy of the document. Please use the
document number 159 to identify the guidance you are requesting.

III. Petition

    On July 10, 2019, FDA received a petition requesting an exemption
from premarket notification for powered wheeled stretchers (see Docket
No. FDA-2019-P-3347). These devices are currently classified under 21
CFR 890.3690, powered wheeled stretchers.
    In the Federal Register of September 16, 2019 (84 FR 48623), FDA
published a notice announcing that this petition had been received and
provided opportunity for interested persons to submit comments on the
petition by November 15, 2019. FDA received no comments.
    FDA has assessed the need for 510(k) clearance for this type of
device against the criteria laid out in the Class II 510(k) Exemption
Guidance. Based on this review, FDA believes that premarket
notification is not necessary to assure the safety and effectiveness of
the device, as long as certain conditions are met. FDA believes that
the risks posed by the device and the characteristics of the device
necessary for its safe and effective performance are well established.
FDA believes that changes in the device that could affect safety and
effectiveness will be readily detectable by visual examination.
Therefore, after reviewing the petition, FDA has determined that
premarket notification is not necessary to assure the safety and
effectiveness of powered wheeled stretchers, as long as the conditions
in section IV are met. FDA responded to the petition by letter dated
December 31, 2019, to inform the petitioner of this decision within the
180-day timeframe under section 510(m)(2) of the FD&C Act.

IV. Conditions for Exemption

    This final order provides conditions for exemption from premarket
notification for the powered wheeled stretcher.\1\ The conditions that
must be met for the device to be 510(k)-exempt are as follows:
Appropriate analysis and nonclinical testing must demonstrate that the
safety controls are adequate to ensure safe use of the device and
prevent user falls from the device in the event of a device failure;
appropriate analysis and nonclinical testing must demonstrate the
ability of the device to withstand the rated user weight load with an
appropriate factor of safety; appropriate analysis and nonclinical
testing must demonstrate the longevity of the device to withstand
external forces applied to the device and provide the user with an
expected service life of the device; appropriate analysis and
nonclinical testing must demonstrate proper environments of use and
storage of the device to maximize the longevity of the device;
appropriate analysis and nonclinical testing (such as outlined in
appropriate FDA-recognized consensus standards) must validate
electromagnetic compatibility and electrical safety; appropriate
analysis and nonclinical testing (such as outlined in appropriate FDA-
recognized consensus standards) must validate that the skin-contacting
components of the device are biocompatible; appropriate analysis and
nonclinical testing (such as outlined in appropriate FDA-recognized
consensus standards) must validate the software life cycle and that all
processes, activities, and tasks are implemented and documented;
appropriate analysis and nonclinical testing must validate that the
device components are found to be nonflammable; appropriate analysis
and nonclinical testing (such as outlined in appropriate FDA-recognized
consensus standards) must validate that the battery in the device
performs as intended over the anticipated service life of the device;
adequate labeling is provided to the user to document proper use and
maintenance of the device to ensure safe use of the device in the
intended use environment; and appropriate risk assessment including,
but not limited to, evaluating the dimensional limits of the gaps in
hospital beds and mitigation strategy to reduce entrapment.
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    \1\ FDA notes that the ``ACTION'' caption for this final order
is styled as ``Final amendment; final order,'' rather than ``Final
order.'' Beginning in December 2019, this editorial change was made
to indicate that the document ``amends'' the Code of Federal
Regulations. The change was made in accordance with the Office of
Federal Register's (OFR) interpretations of the Federal Register Act
(44 U.S.C. chapter 15), its implementing regulations (1 CFR 5.9 and
parts 21 and 22), and the Document Drafting Handbook.
---------------------------------------------------------------------------

    A number of these conditions involve ``appropriate analysis and
nonclinical testing,'' the details of which are outlined in, among
other places, certain FDA-recognized consensus standards. The following
is a list of FDA recognized consensus standards that may be used to
meet the listed conditions of exemption. Specifically, those standards
include FDA-recognized editions of:

 ANSI/AAMI ES60601-1: Medical electrical equipment--Part 1:
General requirements for basic safety and essential performance
 ANSI/AAMI/IEC 60601-1-2: Medical electrical equipment--Part 1-
2: General requirements for basic safety and essential performance--
Collateral Standard: Electromagnetic disturbances--Requirements and
tests
 ISO 7176-14: Wheelchairs--Part 14: Power and control systems
for electrically powered wheelchairs and scooters--Requirements and
test methods
 ISO 7176-21: Wheelchairs--Part 21: Requirements and test
methods for electromagnetic compatibility of electrically powered
wheelchairs and scooters, and battery chargers
 ANSI/AAMI/ISO 10993-1: Biological evaluation of medical
devices--Part 1: Evaluation and testing within a risk management
process
 ANSI/AAMI/ISO 10993-5: Biological evaluation of medical
devices--Part 5: Tests for in vitro cytotoxicity
 AAMI/ANSI/ISO 10993-10: Biological evaluation of medical
devices--Part 10: Tests for irritation and skin sensitization
 IEC 62304: Medical device software--Software life cycle
processes
 ISO 7176-25: Wheelchairs--Part 25: Batteries and chargers for
powered wheelchairs

    We also recommend you consider FDA's guidance entitled ``Hospital
Bed System Dimensional and Assessment Guidance to Reduce Entrapment''
when considering the appropriate risk assessment referenced in the
conditions set forth above.
    Firms are now exempt from 510(k) requirements for powered wheeled
stretchers as long as they meet these conditions, subject to the
limitations on exemption in 21 CFR 890.9. Firms must comply with the
particular conditions set forth in the conditions for exemption or
submit and receive clearance for a 510(k) prior to marketing.

V. Analysis of Environmental Impact

    The Agency has determined under 21 CFR 25.30(h) that this action is
of a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.

VI. Paperwork Reduction Act of 1995

    This final order refers to previously approved FDA collections of

information. These collections of information are subject to review by
the Office of Management and Budget (OMB) under the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501-3521). The collections of information in 21
CFR part 820, regarding quality system regulation, have been approved
under OMB control number 0910-0073; the collections of information in
part 807, subpart E, regarding premarket notification submissions, have
been approved under OMB control number 0910-0120; and the collections
of information in 21 CFR parts 801 and 809, regarding labeling, have
been approved under OMB control number 0910-0485.

List of Subjects in 21 CFR Part 890

    Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
890 is amended as follows:

PART 890--PHYSICAL MEDICINE DEVICES

0
1. The authority citation for part 890 continues to read as follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

0
2. In Sec.  890.3690, revise paragraph (b) to read as follows:

Sec.  890.3690  Powered wheeled stretcher.

* * * * *
    (b) Classification. Class II (performance standards). The powered
wheeled stretcher is exempt from premarket notification procedures in
subpart E of part 807 of this chapter, subject to Sec.  890.9, and the
following conditions for exemption:
    (1) Appropriate analysis and nonclinical testing must demonstrate
that the safety controls are adequate to ensure safe use of the device
and prevent user falls from the device in the event of a device
failure;
    (2) Appropriate analysis and nonclinical testing must demonstrate
the ability of the device to withstand the rated user weight load with
an appropriate factor of safety;
    (3) Appropriate analysis and nonclinical testing must demonstrate
the longevity of the device to withstand external forces applied to the
device and provide the user with an expected service life of the
device;
    (4) Appropriate analysis and nonclinical testing must demonstrate
proper environments of use and storage of the device to maximize the
longevity of the device;
    (5) Appropriate analysis and nonclinical testing (such as outlined
in appropriate FDA-recognized consensus standards) must validate
electromagnetic compatibility and electrical safety;
    (6) Appropriate analysis and nonclinical testing (such as outlined
in appropriate FDA-recognized consensus standards) must validate that
the skin-contacting components of the device are biocompatible;
    (7) Appropriate analysis and nonclinical testing (such as outlined
in appropriate FDA-recognized consensus standards) must validate the
software life cycle and that all processes, activities, and tasks are
implemented and documented;
    (8) Appropriate analysis and nonclinical testing must validate that
the device components are found to be nonflammable;
    (9) Appropriate analysis and nonclinical testing (such as outlined
in appropriate FDA-recognized consensus standards) must validate that
the battery in the device performs as intended over the anticipated
service life of the device;
    (10) Adequate labeling is provided to the user to document proper
use and maintenance of the device to ensure safe use of the device in
the intended use environment; and
    (11) Appropriate risk assessment including, but not limited to,
evaluating the dimensional limits of the gaps in hospital beds, and
mitigation strategy to reduce entrapment.

    Dated: January 7, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-00295 Filed 1-13-20; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 87, Number 25 (Monday, February 7, 2022)]
[Proposed Rules]
[Pages 6798-6801]
[FR Doc No: 2022-02319]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2022-0087; Project Identifier MCAI-2021-01025-T]
RIN 2120-AA64

Airworthiness Directives; Airbus SAS Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: The FAA proposes to supersede Airworthiness Directive (AD)
2020-21-06, which applies to certain Airbus SAS Model A350-941 and -
1041 airplanes. AD 2020-21-06 requires revising the existing
maintenance or inspection program, as applicable, to incorporate new or
more restrictive airworthiness limitations. Since the FAA issued AD
2020-21-06, the FAA has determined that new or more restrictive
airworthiness limitations are necessary. This proposed AD would revise
the applicability by adding airplanes and require revising the existing
maintenance or inspection program, as applicable, to incorporate new or
more restrictive airworthiness limitations, as specified in a European
Union Aviation Safety Agency (EASA) AD, which is proposed for
incorporation by reference. The FAA is proposing this AD to address the
unsafe condition on these products.

DATES: The FAA must receive comments on this proposed AD by March 24,
2022.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to https://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 W12-140, 1200 New
Jersey Avenue SE,

Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays.
    For material that will be incorporated by reference (IBR) in this
AD, contact the EASA, Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany;
telephone +49 221 8999 000; email [email protected]; internet
www.easa.europa.eu. You may find this IBR material on the EASA website
at https://ad.easa.europa.eu. You may view this IBR material at the
FAA, Airworthiness Products Section, Operational Safety Branch, 2200
South 216th St., Des Moines, WA. For information on the availability of
this material at the FAA, call<PHONE_NUMBER>. It is also available in
the AD docket on the internet at https://www.regulations.gov by
searching for and locating Docket No. FAA-2022-0087.

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-2022-
0087; 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 NPRM, any comments received, and other information. The street
address for Docket Operations is listed above. Comments will be
available in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Dan Rodina, Aerospace Engineer, Large
Aircraft Section, FAA, International Validation Branch, 2200 South
216th St., Des Moines, WA 98198; telephone and fax<PHONE_NUMBER>; email
[email protected].

SUPPLEMENTARY INFORMATION:

Comments Invited

    The FAA invites you to send any written relevant data, views, or
arguments about this proposal. Send your comments to an address listed
under ADDRESSES. Include ``Docket No. FAA-2022-0087; Project Identifier
MCAI-2021-01025-T'' at the beginning of your comments. The most helpful
comments reference a specific portion of the proposal, explain the
reason for any recommended change, and include supporting data. The FAA
will consider all comments received by the closing date and may amend
the proposal because of those comments.
    Except for Confidential Business Information (CBI) as described in
the following paragraph, and other information as described in 14 CFR
11.35, the FAA will post all comments received, without change, to
https://www.regulations.gov, including any personal information you
provide. The agency will also post a report summarizing each
substantive verbal contact received about this proposed AD.

Confidential Business Information

    CBI is commercial or financial information that is both customarily
and actually treated as private by its owner. Under the Freedom of
Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public
disclosure. If your comments responsive to this NPRM contain commercial
or financial information that is customarily treated as private, that
you actually treat as private, and that is relevant or responsive to
this NPRM, it is important that you clearly designate the submitted
comments as CBI. Please mark each page of your submission containing
CBI as ``PROPIN.'' The FAA will treat such marked submissions as
confidential under the FOIA, and they will not be placed in the public
docket of this NPRM. Submissions containing CBI should be sent to Dan
Rodina, Aerospace Engineer, Large Aircraft Section, FAA, International
Validation Branch, 2200 South 216th St., Des Moines, WA 98198;
telephone and fax<PHONE_NUMBER>; email [email protected]. Any
commentary that the FAA receives which is not specifically designated
as CBI will be placed in the public docket for this rulemaking.

Background

    The FAA issued AD 2020-21-06, Amendment 39-21279 (85 FR 64961,
October 14, 2020) (AD 2020-21-06), for certain Airbus SAS Model A350-
941 and -1041 airplanes. AD 2020-21-06 requires revising the existing
maintenance or inspection program, as applicable, to incorporate new or
more restrictive airworthiness limitations. The FAA issued AD 2020-21-
06 to address the potential failure of certain life-limited parts,
which could result in reduced structural integrity of the airplane.

Actions Since AD 2020-21-06 Was Issued

    Since the FAA issued AD 2020-21-06, the FAA has determined that new
or more restrictive airworthiness limitations are necessary for
airplane structures and safe life limits.
    EASA, which is the Technical Agent for the Member States of the
European Union, has issued EASA AD 2021-0206, dated September 15, 2021
(EASA AD 2021-0206) (also referred to as the Mandatory Continuing
Airworthiness Information, or the MCAI), to correct an unsafe condition
for all Airbus SAS Model A350-941 and -1041 airplanes.
    Airplanes with an original airworthiness certificate or original
export certificate of airworthiness issued after June 30, 2021, must
comply with the airworthiness limitations specified as part of the
approved type design and referenced on the type certificate data sheet;
this proposed AD therefore does not include those airplanes in the
applicability.
    This proposed AD was prompted by a determination that new or more
restrictive airworthiness limitations are necessary. The FAA is
proposing this AD to address the potential failure of certain life-
limited parts, which could result in reduced structural integrity of
the airplane. See the MCAI for additional background information.

Related Service Information Under 1 CFR Part 51

    EASA AD 2021-0206 describes new or more restrictive airworthiness
limitations for airplane structures and safe life limits.
    This AD would also require EASA AD 2020-0091, dated April 22, 2020,
which the Director of the Federal Register approved for incorporation
by reference as of November 18, 2020 (85 FR 64961, October 14, 2020).
    This material 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.

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 the FAA's bilateral agreement with the State of Design Authority,
the FAA has been notified of the unsafe condition described in the MCAI
referenced above. The FAA is proposing this AD because the FAA has
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.

Proposed AD Requirements

    This proposed AD would retain the requirements of AD 2020-21-06.
This proposed AD would revise the applicability by adding airplanes and
also require revising the existing maintenance or inspection program,
as applicable, to incorporate new or more restrictive airworthiness
limitations, which are specified in EASA AD 2021-0206 described
previously, as

incorporated by reference. Any differences with EASA AD 2021-0206 are
identified as exceptions in the regulatory text of this AD.
    This proposed AD would require revisions to certain operator
maintenance documents to include new actions (e.g., inspections).
Compliance with these actions is required by 14 CFR 91.403(c). For
airplanes that have been previously modified, altered, or repaired in
the areas addressed by this proposed AD, the operator may not be able
to accomplish the actions described in the revisions. In this
situation, to comply with 14 CFR 91.403(c), the operator must request
approval for an alternative method of compliance according to paragraph
(m)(1) of this proposed AD.

Explanation of Required Compliance Information

    In the FAA's ongoing efforts to improve the efficiency of the AD
process, the FAA developed a process to use some civil aviation
authority (CAA) ADs as the primary source of information for compliance
with requirements for corresponding FAA ADs. The FAA has been
coordinating this process with manufacturers and CAAs. As a result, the
FAA proposes to incorporate EASA AD 2021-0206 by reference in the FAA
final rule. This proposed AD would, therefore, require compliance with
EASA AD 2021-0206 in its entirety through that incorporation, except
for any differences identified as exceptions in the regulatory text of
this proposed AD. Using common terms that are the same as the heading
of a particular section in EASA AD 2021-0206 does not mean that
operators need comply only with that section. For example, where the AD
requirement refers to ``all required actions and compliance times,''
compliance with this AD requirement is not limited to the section
titled ``Required Action(s) and Compliance Time(s)'' in EASA AD 2021-
0206. Service information required by EASA AD 2021-0206 for compliance
will be available at https://www.regulations.gov by searching for and
locating Docket No. FAA-2022-0087 after the FAA final rule is
published.

Airworthiness Limitation ADs Using the New Process

    The FAA's process of incorporating by reference MCAI ADs as the
primary source of information for compliance with corresponding FAA ADs
has been limited to certain MCAI ADs (primarily those with service
bulletins as the primary source of information for accomplishing the
actions required by the FAA AD). However, the FAA is now expanding the
process to include MCAI ADs that require a change to airworthiness
limitation documents, such as airworthiness limitation sections.
    For these ADs that incorporate by reference an MCAI AD that changes
airworthiness limitations, the FAA requirements are unchanged.
Operators must revise the existing maintenance or inspection program,
as applicable, to incorporate the information specified in the new
airworthiness limitation document. The airworthiness limitations must
be followed according to 14 CFR 91.403(c) and 91.409(e).
    The previous format of the airworthiness limitation ADs included a
paragraph that specified that no alternative actions (e.g.,
inspections) or intervals may be used unless the actions and intervals
are approved as an alternative method of compliance (AMOC) in
accordance with the procedures specified in the AMOCs paragraph under
``Other FAA Provisions.'' This new format includes a ``New Provisions
for Alternative Actions or Intervals'' paragraph that does not
specifically refer to AMOCs, but operators may still request approval
of an AMOC to use an alternative action or interval.

Costs of Compliance

    The FAA estimates that this proposed AD affects 24 airplanes of
U.S. registry. The FAA estimates the following costs to comply with
this proposed AD:
    The FAA estimates the total cost per operator for the retained
actions from AD 2020-21-06 to be $7,650 (90 work-hours x $85 per work-
hour).
    The FAA has determined that revising the existing maintenance or
inspection program takes an average of 90 work-hours per operator,
although the agency recognizes that this number may vary from operator
to operator. Since operators incorporate maintenance or inspection
program changes for their affected fleet(s), the FAA has determined
that a per-operator estimate is more accurate than a per-airplane
estimate.
    The FAA estimates the total cost per operator for the new proposed
actions to be $7,650 (90 work-hours x $85 per work-hour).

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 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) 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 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

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 (AD) 2020-21-06, Amendment 39-21279
(85 FR 64961, October 14, 2020); and
0
b. Adding the following new AD:

Airbus SAS: Docket No. FAA-2022-0087; Project Identifier MCAI-2021-
01025-T.

(a) Comments Due Date

    The FAA must receive comments on this airworthiness directive
(AD) by March 24, 2022.

(b) Affected ADs

    This AD replaces AD 2020-21-06, Amendment 39-21279 (85 FR 64961,
October 14, 2020) (AD 2020-21-06).

(c) Applicability

    This AD applies to Airbus SAS Model A350-941 and -1041
airplanes, certificated in any category, with an original
airworthiness certificate or original export certificate of
airworthiness issued on or before June 30, 2021.

(d) Subject

    Air Transport Association (ATA) of America Code 05, Time Limits/
Maintenance Checks.

(e) Reason

    This AD was prompted by a determination that new or more
restrictive airworthiness limitations are necessary. The FAA is
issuing this AD to address the potential failure of certain life-
limited parts, which could result in reduced structural integrity of
the airplane.

(f) Compliance

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

(g) Retained Maintenance or Inspection Program Revision, With No
Changes

    This paragraph restates the requirements of paragraph (g) of AD
2020-21-06, with no changes. For airplanes with an original
airworthiness certificate or original export certificate of
airworthiness issued on or before June 7, 2019: Except as specified
in paragraph (h) of this AD, comply with all required actions and
compliance times specified in, and in accordance with, European
Union Aviation Safety Agency (EASA) AD 2020-0091, dated April 22,
2020 (EASA AD 2020-0091). Accomplishing the revision of the existing
maintenance or inspection program required by paragraph (j) of this
AD terminates the requirements of this paragraph.

(h) Retained Exceptions to EASA AD 2020-0091, With No Changes

    This paragraph restates the requirements of paragraph (h) of AD
2020-21-06, with no changes. For airplanes with an original
airworthiness certificate or original export certificate of
airworthiness issued on or before June 7, 2019:
    (1) The requirements specified in paragraph (1) of EASA AD 2020-
0091 do not apply to this AD.
    (2) Paragraph (2) of EASA AD 2020-0091 specifies revising ``the
approved AMP'' within 12 months after its effective date, but this
AD requires revising the existing maintenance or inspection program,
as applicable, to incorporate the ``limitations'' specified in
paragraph (2) of EASA AD 2020-0091 within 90 days after November 18,
2020 (the effective date of AD 2020-21-06).
    (3) The initial compliance time for complying with the
limitations specified in paragraph (2) of EASA AD 2020-0091 is at
the applicable ``limitations'' specified in paragraph (2) of EASA AD
2020-0091, or within 90 days after November 18, 2020 (the effective
date of AD 2020-21-06), whichever occurs later.
    (4) The provisions specified in paragraphs (3) and (4) of EASA
AD 2020-0091 do not apply to this AD.
    (5) The ``Remarks'' section of EASA AD 2020-0091 does not apply
to this AD.

(i) Retained Provisions for Alternative Actions and Intervals, With a
New Exception

    This paragraph restates the requirements of paragraph (i) of AD
2020-21-06, with a new exception. For airplanes with an original
airworthiness certificate or original export certificate of
airworthiness issued on or before June 7, 2019: Except as required
by paragraph (j) of this AD, after the existing maintenance or
inspection program has been revised as required by paragraph (g) of
this AD, no alternative actions (e.g., inspections) and intervals
are allowed unless they are approved as specified in the provisions
of the ``Ref. Publications'' section of EASA AD 2020-0091.

(j) New Maintenance or Inspection Program Revision

    Except as specified in paragraph (k) of this AD: Comply with all
required actions and compliance times specified in, and in
accordance with, EASA AD 2021-0206, dated September 15, 2021 (EASA
AD 2021-0206). Accomplishing the revision of the existing
maintenance or inspection program required by this paragraph
terminates the requirements of paragraph (g) of this AD.

(k) Exceptions to EASA AD 2021-0206

    (1) Where EASA AD 2021-0206 refers to its effective date, this
AD requires using the effective date of this AD.
    (2) The requirement specified in paragraph (1) of EASA AD 2021-
0206 does not apply to this AD.
    (3) Paragraph (2) of EASA AD 2021-0206 specifies revising ``the
approved AMP'' within 12 months after its effective date, but this
AD requires revising the existing maintenance or inspection program,
as applicable, within 90 days after the effective date of this AD.
    (4) The initial compliance time for doing the tasks specified in
paragraph (2) of EASA 2021-0206 is at the applicable ``limitations''
as incorporated by the requirements of paragraph (2) of EASA AD
2021-0206, or within 90 days after the effective date of this AD,
whichever occurs later.
    (5) The provisions specified in paragraph (3) and (4) of EASA AD
2021-0206 do not apply to this AD.
    (6) The ``Remarks'' section of EASA AD 2021-0206 does not apply
to this AD.

(l) New Provisions for Alternative Actions and Intervals

    After the revision of the existing maintenance or inspection
program has been accomplished as required by paragraph (j) of this
AD, no alternative actions (e.g., inspections) and intervals are
allowed unless they are approved as specified in the provisions of
the ``Ref. Publications'' section of EASA AD 2021-0206.

(m) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
Large Aircraft Section, International Validation 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 responsible Flight
Standards Office, as appropriate. If sending information directly to
the Large Aircraft Section, International Validation Branch, send it
to the attention of the person identified in paragraph (n)(2) of
this AD. Information may be emailed to: [email protected].
Before using any approved AMOC, notify your appropriate principal
inspector, or lacking a principal inspector, the manager of the
responsible Flight Standards Office.
    (2) Contacting the Manufacturer: For any requirement in this AD
to obtain instructions from a manufacturer, the instructions must be
accomplished using a method approved by the Manager, Large Aircraft
Section, International Validation Branch, FAA; or EASA; or Airbus
SAS's EASA Design Organization Approval (DOA). If approved by the
DOA, the approval must include the DOA-authorized signature.

(n) Related Information

    (1) For information about EASA AD 2020-0091 and AD 2021-0206,
contact the EASA, Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany;
telephone +49 221 8999 000; email [email protected]; internet
www.easa.europa.eu. You may find this EASA AD on the EASA website at
https://ad.easa.europa.eu. You may view this material at the FAA,
Airworthiness Products Section, Operational Safety Branch, 2200
South 216th St., Des Moines, WA. For information on the availability
of this material at the FAA, call<PHONE_NUMBER>. This material may be
found in the AD docket on the internet at https://www.regulations.gov by searching for and locating Docket No. FAA-
2022-0087.
    (2) For more information about this AD, contact Dan Rodina,
Aerospace Engineer, Large Aircraft Section, FAA, International
Validation Branch, 2200 South 216th St., Des Moines, WA 98198;
telephone and fax<PHONE_NUMBER>; email [email protected].

    Issued on January 31, 2022.
Lance T. Gant,
Director, Compliance & Airworthiness Division, Aircraft Certification
Service.
[FR Doc. 2022-02319 Filed 2-4-22; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: October 24, 2007 (Volume 72, Number 205)]
[Rules and Regulations]
[Page 60231-60233]
[DOCID:fr24oc07-3]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2007-28923; Directorate Identifier 2007-NM-133-AD;
Amendment 39-15242; AD 2007-22-06]
RIN 2120-AA64

Airworthiness Directives; Fokker Model F.28 Mark 0070 and 0100
Airplanes

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Final rule.

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

SUMMARY: We are adopting a new airworthiness directive (AD) for the
products listed above. This 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:

    Over the years, several Fokker 100 (F28 Mark 0100) operators
reported that a MLG (main landing gear) wheel fell off during
regular operation of the aircraft. These incidents occurred due to a
missing spacer, which had inadvertently not been installed during a
previous wheel change. Omitting the installation of the wheel spacer
allows the wheel to move sideways along the axle, which subsequently
leads to bearing failure, followed by loss of the wheel. * * * This
condition, if not corrected, * * * could conceivably result in loss
of control of the aircraft during the take-off run, landing rollout
or taxiing operations. * * *

We are issuing this AD to require actions to correct the unsafe
condition on these products.

DATES: This AD becomes effective November 28, 2007.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of November 28,
2007.

ADDRESSES: You may examine the AD docket on the Internet at http://dms.dot.gov
 or in person at the U.S. Department of Transportation,

Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200
New Jersey Avenue, SE., Washington, DC.

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:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 to include an AD that would apply to the specified products.
That NPRM was published in the Federal Register on August 16, 2007 (72
FR 45956). That NPRM proposed to correct an unsafe condition for the
specified products. The MCAI states:

    Over the years, several Fokker 100 (F28 Mark 0100) operators
reported that a MLG (main landing gear) wheel fell off during
regular operation of the aircraft. These incidents occurred due to a
missing spacer, which had inadvertently not been installed during a
previous wheel change. Omitting the installation of the wheel spacer
allows the wheel to move sideways along the axle, which subsequently
leads to bearing failure, followed by loss of the wheel.
Investigation by Fokker and Messier-Dowty has shown that two
separate items, the spacer and the axle nut, can be replaced by a
single axle-nut/spacer assembly, to prevent the possibility of
omitting the spacer. In 1995, Messier-Dowty issued Service Bulletin
(SB) F100-32-72 to make sure that the operator does not assemble the
axle nut without the spacer. Fokker subsequently issued SB F100-32-
096 to notify Fokker 100 operators of the (optional) Messier-Dowty
SB's existence. At a later stage, Fokker revised the SB to the
status of ``recommended''. In spite of all this attention to the
spacer problem, wheel losses are still being reported due to missing
wheel nut spacers. This condition, if not corrected, may lead to
further wheel loss incidents, each of which could conceivably result
in loss of control of the aircraft during the take-off run, landing
rollout or taxiing operations. Since a potentially unsafe condition
has been identified that may exist or develop on aircraft of the
same type design, this Airworthiness Directive requires the
replacement of the axle-nut and spacer with an integrated axle-nut/
spacer assembly. In addition, the Aircraft Maintenance Manual (AMM)
and Illustrated Parts Catalogue (IPC) must be amended to prevent
reversal to a separate axle-nut and spacer installation during a
subsequent wheel change.

You may obtain further information by examining the MCAI in the AD
docket.

Comments

    We gave the public the opportunity to participate in developing
this AD. We received no comments on the NPRM or on the determination of
the cost to the public.

Conclusion

    We reviewed the available data and determined that air safety and
the public interest require adopting the AD as proposed.

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 required different actions in this AD from those
in the MCAI in order to follow our FAA policies. Any such differences
are highlighted in a NOTE within the AD.

Costs of Compliance

    We estimate that this AD will affect 13 products of U.S. registry.
We also estimate that it will take about 4 work-hours per product to
comply with the basic requirements of this AD. The average labor rate
is $80 per work-hour. Required parts will cost about $3,750 per
product. Where the service information lists required parts costs that
are covered under warranty, we have assumed that there will be no
charge for these parts. As we do not control warranty coverage for
affected parties, some parties may incur costs higher than estimated
here. Based on these figures, we estimate the cost of this AD to the
U.S. operators to be $52,910, or $4,070 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 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. 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 AD and placed it in the AD docket.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://dms.dot.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 the NPRM, 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.

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

0
Accordingly, under the authority delegated to me by the Administrator,
the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

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

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new AD:

2007-22-06 Fokker Services B.V.: Amendment 39-15242. Docket No. FAA-
2007-28923; Directorate Identifier 2007-NM-133-AD.

Effective Date

    (a) This airworthiness directive (AD) becomes effective November
28, 2007.

Affected ADs

    (b) None.

Applicability

    (c) This AD applies to Fokker Model F.28 Mark 0070 and 0100
airplanes; certificated in any category; all serial numbers, if
equipped with Messier-Dowty main landing gear (MLG) units.

Subject

    (d) Air Transport Association (ATA) of America Code 32: Landing
gear.

Reason

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

    Over the years, several Fokker 100 (F28 Mark 0100) operators
reported that a MLG (main landing gear) wheel fell off during
regular operation of the aircraft. These incidents occurred due to a
missing spacer, which had inadvertently not been installed during a
previous wheel change. Omitting the installation of the wheel spacer
allows the wheel to move sideways along the axle, which subsequently
leads to bearing failure, followed by loss of the wheel.
Investigation by Fokker and Messier-Dowty has shown that two
separate items, the spacer and the axle nut, can be replaced by a
single axle-nut/spacer assembly, to prevent the possibility of
omitting the spacer. In 1995, Messier-Dowty issued Service Bulletin
(SB) F100-32-72 to make sure that the operator does not assemble the
axle nut without the spacer. Fokker subsequently issued SB F100-32-
096 to notify Fokker 100 operators of the (optional) Messier-Dowty
SB's existence. At a later stage, Fokker revised the SB to the
status of ``recommended''. In spite of all this attention to the
spacer problem, wheel losses are still being reported due to missing
wheel nut spacers. This condition, if not corrected, may lead to
further wheel loss incidents, each of which could conceivably result
in loss of control of the aircraft during the take-off run, landing
rollout or taxiing operations. Since a potentially unsafe condition
has been identified that may exist or develop on aircraft of the
same type design, this Airworthiness Directive requires the
replacement of the axle-nut and spacer with an integrated axle-nut/
spacer assembly. In addition, the Aircraft Maintenance Manual (AMM)
and Illustrated Parts Catalogue (IPC) must be amended to prevent
reversal to a separate axle-nut and spacer installation during a
subsequent wheel change.

Actions and Compliance

    (f) Unless already done, do the following actions.
    (1) Within 12 months after the effective date of this AD,
replace each MLG wheel axle-nut and spacer with an integrated axle-
nut/spacer assembly in accordance with the Accomplishment
Instructions of Messier-Dowty Service Bulletin F100-32-72, Revision
1, dated March 5, 2007.

    Note 1: Fokker 70/100 Service Letter 102, Revision 1, dated
February 12, 1998; and Fokker Service Bulletin SBF100-32-096,
Revision 2, dated April 29, 2005; also pertain to this subject.

    (2) As of 12 months after the effective date of this AD, no
person may install an axle nut having part number (P/N) 201072670 or
alternate P/N 201072765, or any spacer having P/N 201072699, on any
airplane. Only axle nut subassemblies having P/N 201251273 or P/N
201650216 may be installed.
    (3) Actions accomplished before the effective date of this AD in
accordance with Messier-Dowty Service Bulletin F100-32-72, dated
January 25, 1995, are considered acceptable for compliance with the
corresponding action specified in this AD.

FAA AD Differences

    Note 2: This AD differs from the MCAI and/or service information
as follows:
    (1) The MCAI requires revising the AMM and IPC. As these
documents are not FAA-approved, we do not require these revisions.
Therefore, this AD requires compliance with paragraph (f)(2) of this
AD, which accomplishes the intent of revising the AMM and IPC.

Other FAA AD Provisions

    (g) 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 appropriate principal inspector (PI) in the FAA
Flight Standards District Office (FSDO), or lacking a PI, your local
FSDO.
    (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, the
Office of Management and Budget (OMB) has approved the information
collection requirements and has assigned OMB Control Number 2120-
0056.

Related Information

    (h) Refer to MCAI Dutch Airworthiness Directive NL-2005-008,
dated June 30, 2005, and the service information identified in Table
1 of this AD, for related information.

                  Table 1.--Related Service Information
------------------------------------------------------------------------
     Service information       Revision level             Date
------------------------------------------------------------------------
Fokker 70/100 Service Letter                1  February 12, 1998.
 102.
Fokker Service Bulletin                     2  April 29, 2005.
 SBF100-32-096.
Messier-Dowty Service                       1  March 5, 2007.
 Bulletin F100-32-72.
------------------------------------------------------------------------

Material Incorporated by Reference

    (i) You must use Messier-Dowty Service Bulletin F100-32-72,
Revision 1, dated March 5, 2007, to do the actions required by this
AD, unless the AD specifies otherwise.
    (1) The Director of the Federal Register approved the
incorporation by reference of this service information under 5
U.S.C. 552(a) and 1 CFR part 51.
    (2) For service information identified in this AD, contact
Fokker Services B.V., Technical Services Dept., P.O. Box 231, 2150
AE Nieuw-Vennep, the Netherlands.
    (3) You may review copies at the FAA, Transport Airplane
Directorate, 1601 Lind Avenue SW., Renton, Washington; or at the
National Archives and Records Administration (NARA). For information
on the availability of this material at NARA, call<PHONE_NUMBER>,
or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html
.

    Issued in Renton, Washington, on October 12, 2007.
Stephen P. Boyd,
Assistant Manager, Transport Airplane Directorate, Aircraft
Certification Service.
 [FR Doc. E7-20814 Filed 10-23-07; 8:45 am]

BILLING CODE 4910-13-P


[Federal Register Volume 86, Number 140 (Monday, July 26, 2021)]
[Proposed Rules]
[Pages 39988-39989]
[FR Doc No: 2021-15736]

=======================================================================
-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R07-OAR-2019-0707; FRL-8684-03-R7]

Air Plan Approval; Missouri; Open Burning; Withdrawal

AGENCY: Environmental Protection Agency (EPA).

ACTION: Withdrawal of proposed rule.

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

SUMMARY: The Environmental Protection Agency (EPA) is withdrawing its
proposed rule to approve Missouri's revisions to the state's open
burning rule, as published in the Federal Register on January 13, 2020.
By a letter to the EPA dated May 26, 2021, Missouri withdrew its
request for approval of revisions to this rule in the state
implementation plan (SIP).

DATES: The proposed rule published on January 13, 2020 (85 FR 1794) is
withdrawn as of July 26, 2021.

FOR FURTHER INFORMATION CONTACT: Wendy Vit, Environmental Protection
Agency, Region 7 Office, Air Quality Planning Branch, 11201 Renner
Boulevard, Lenexa, Kansas 66219 at<PHONE_NUMBER>, or by email at
<EMAIL_ADDRESS>

SUPPLEMENTARY INFORMATION: Missouri has withdrawn the rule as stated in
the letter dated May 26, 2021, which is included in the docket for this
action. Because the EPA received adverse comments on its proposed rule,
the EPA is publishing this notice of withdrawal to notify commenters
that it no longer intends to take final action on the revisions
proposed to 10 CSR 10-6.045 on January 13, 2020 at 85 FR 1794.

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Carbon monoxide,
Incorporation by reference, Intergovernmental relations, Lead, Nitrogen
dioxide, Ozone, Particulate matter, Reporting and recordkeeping
requirements, Sulfur oxides, Volatile organic compounds.

    Dated: July 19, 2021.
Edward H. Chu,
Acting Regional Administrator, Region 7.
[FR Doc. 2021-15736 Filed 7-23-21; 8:45 am]
BILLING CODE 6560-50-P


                                  Cover Sheet

Items: HCl, THC, and TEQ UPL calculations for BF stoves and BOPFs. HCl and THC UPL calculations for blast furnaces. HCl, Mercury, TEQ, HF, PAH, COS, and CS2 UPL calculations for sinter plant windboxes.


[Federal Register: September 20, 2010 (Volume 75, Number 181)]
[Notices]
[Page 57268]
[DOCID:fr20se10-41]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. PR10-103-000; Docket No. PR10-104-000; Docket No. PR10-105-
000 (Not Consolidated)]

Notice of Baseline Filings

September 13, 2010.

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

------------------------------------------------------------------------
Duke Energy Ohio, Inc.....................  Docket No. PR10-103-000.
Duke Energy Kentucky, Inc.................  Docket No. PR10-104-000.
Washington Gas Light Company..............  Docket No. PR10-105-000.
                                            (Not Consolidated).
------------------------------------------------------------------------

    Take notice that on September 9, 2010, and September 10, 2010,
respectively the applicants listed above submitted their baseline
filing of its Statement of Operating Conditions for services provided
under section 311 of the Natural Gas Policy Act of 1978 (NGPA).
    Any person desiring to participate in this rate proceeding must
file a motion to intervene or to protest this filing must file in
accordance with Rules 211 and 214 of the Commission's Rules of Practice
and Procedure (18 CFR 385.211 and 385.214). Protests will be considered
by the Commission in determining the appropriate action to be taken,
but will not serve to make protestants parties to the proceeding. Any
person wishing to become a party must file a notice of intervention or
motion to intervene, as appropriate. Such notices, motions, or protests
must be filed on or before the date as indicated below. Anyone filing
an intervention or protest must serve a copy of that document on the
Applicant. Anyone filing an intervention or protest on or before the
intervention or protest date need not serve motions to intervene or
protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://
www.ferc.gov. Persons unable to file electronically should submit an
original and 7 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern time on Monday, September 27, 2010.

Kimberly D. Bose,
Secretary.
[FR Doc. 2010-23367 Filed 9-17-10; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 82, Number 67 (Monday, April 10, 2017)]
[Proposed Rules]
[Page 17166]
[FR Doc No: 2017-07030]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R05-OAR-2016-0705; FRL-9960-80-Region 5]

Air Plan Approval; Michigan; Transportation Conformity Procedures

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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

SUMMARY: The Environmental Protection Agency (EPA) is proposing to
approve a revision submitted by the State of Michigan on October 3,
2016. The purpose of this revision is to establish transportation
conformity criteria and procedures related to interagency consultation,
and enforceability of certain transportation related control and
mitigation measures.

DATES: Comments must be received on or before May 10, 2017.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R05-
OAR-2015-0705 at http://www.regulations.gov or via email to
<EMAIL_ADDRESS>For comments submitted at Regulations.gov,
follow the online instructions for submitting comments. Once submitted,
comments cannot be edited or removed from Regulations.gov. For either
manner of submission, EPA may publish any comment received to its
public docket. Do not submit electronically any information you
consider to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute. Multimedia
submissions (audio, video, etc.) must be accompanied by a written
comment. The written comment is considered the official comment and
should include discussion of all points you wish to make. EPA will
generally not consider comments or comment contents located outside of
the primary submission (i.e. on the web, cloud, or other file sharing
system). For additional submission methods, please contact the person
identified in the For Further Information Contact section. For the full
EPA public comment policy, information about CBI or multimedia
submissions, and general guidance on making effective comments, please
visit http://www2.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: Michael Leslie, Environmental
Engineer, Control Strategies Section, Air Programs Branch (AR-18J),
Environmental Protection Agency, Region 5, 77 West Jackson Boulevard,
Chicago, Illinois 60604,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In the Rules section of this Federal
Register, EPA is approving Michigan's state implementation plan
submittal as a direct final rule without prior proposal because the
Agency views this as a noncontroversial submittal and anticipates no
adverse comments. A detailed rationale for the approval is set forth in
the direct final rule. If no adverse comments are received in response
to this rule, no further activity is contemplated. If EPA receives
adverse comments, the direct final rule will be withdrawn and all
public comments received will be addressed in a subsequent final rule
based on this proposed rule. EPA will not institute a second comment
period. Any parties interested in commenting on this action should do
so at this time. Please note that if EPA receives adverse comment on an
amendment, paragraph, or section of this rule and if that provision may
be severed from the remainder of the rule, EPA may adopt as final those
provisions of the rule that are not the subject of an adverse comment.
For additional information, see the direct final rule which is located
in the Rules section of this Federal Register.

    Dated: March 17, 2017.
Robert A. Kaplan,
Acting Regional Administrator, Region 5.
[FR Doc. 2017-07030 Filed 4-7-17; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 81, Number 176 (Monday, September 12, 2016)]
[Notices]
[Pages 62795-62796]
[FR Doc No: 2016-21829]

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

DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2015-0116]

Denial of Exemption Applications; Epilepsy and Seizure Disorders

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

ACTION: Notice of denial.

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

SUMMARY: FMCSA announces its decision to deny applications from 11
individuals who requested an exemption from the Federal Motor Carrier
Safety Regulations (FMCSRs) prohibiting persons with a clinical
diagnosis of epilepsy or any other condition that is likely to cause a
loss of consciousness or any loss of ability to operate a commercial
motor vehicle (CMV) from operating CMVs in interstate commerce.

FOR FURTHER INFORMATION CONTACT: Christine A. Hydock, Chief, 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 8:30 a.m. to 5 p.m., e.t.,
Monday through Friday, except Federal holidays. If you have questions
regarding viewing or submitting material to the docket, contact Docket
Services, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Electronic Access

    You may see all the comments online through the Federal Document
Management System (FDMS) at: http://www.regulations.gov.
    Docket: For access to the docket to read background documents or
comments, go to http://www.regulations.gov and/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., Monday through Friday,
except Federal holidays.
    Privacy Act: In accordance with 5 U.S.C. 553(c), DOT solicits
comments from the public to better inform its rulemaking process. DOT
posts these comments, without edit, including any personal information
the commenter provides, to http://www.regulations.gov, as described in
the system of records notice (DOT/ALL-14 FDMS), which can be reviewed
at http://www.dot.gov/privacy.

II. Background

    On July 13, 2015, FMCSA published a notice announcing receipt of
applications from 21 individuals requesting an exemption from the
prohibition against persons with a clinical diagnosis of epilepsy or
any other condition that is likely to cause a loss of consciousness or
any loss of ability to operate a CMV in interstate commerce and
requested comments from the public (80 FR 40127). The public comment
period closed on August 12, 2015, and 10 comments were received.
    FMCSA has evaluated the eligibility of these applicants and
concluded that granting 11 of the 21 exemptions would not provide a
level of safety that would be equivalent to or greater than, the level
of safety that would be obtained by complying with the regulation 49
CFR 391.41(b)(8). A final notice announcing the decision to grant nine
of 21 exemptions and providing a response to the 10 comments received
was published on September 14, 2015 (80 FR 55170). One of the
applicants in this notice withdrew his request for an exemption.

III. Basis for Exemption Determination

    Under 49 U.S.C. 31136(e) and 31315(b), FMCSA may grant an exemption
from the Federal epilepsy standard for a renewable two-year period if
it finds ``such exemption is likely achieve a level of safety that is
equivalent to or greater than the level that would be achieved absent
such exemption.''
    The Agency's decision regarding these exemption applications is
based on an individualized assessment of each applicant's medical
information, including the root cause of the respective seizure(s) and
medical information about the applicant's seizure history, the length
of time that has elapsed since the individual's last seizure, the
stability of each individual's treatment regimen and the duration of
time on or off of anti-seizure medication. The Agency considered the
2007 recommendations of the Agency's Medical Expert Panel (MEP). The
January 15, 2013 Federal Register notice (78 FR 3069) provides the
current MEP recommendations which is the criteria the Agency uses to
make decisions regarding seizure exemptions.

IV. Conclusion

    The Agency has determined that these 11 applicants do not satisfy
the criteria eligibility or meet the terms and conditions for a Federal
exemption and granting these exemptions would not provide a level of
safety that would be equivalent to or greater than, the level of safety
that would be obtained by complying with the regulation 49 CFR
391.41(b)(8). Therefore, the applicants listed in this notice have been
denied an exemption from the physical qualification standards in 49 CFR
391.41(b)(8).
    Each applicant has, prior to this notice, received a letter of
final disposition regarding his/her exemption request. Those decision
letters fully outlined the basis for the denial and constitutes final
action by the Agency. This notice summarizes the Agency's recent
denials as required under 49 U.S.C. 31315(b)(4) by periodically
publishing names and reasons for denial. The following drivers were
listed previously in Federal Register Notice FMCSA-2015-0116 published
on July 13, 2015:
    Leo Arnold Burns--Mr. Burns has a history of a seizure disorder.
His last seizure was in 2010. He takes anti-seizure medication. He does
not meet the MEP guidelines at this time.
    Rodney Lee Ericson--Mr. Ericson has a history of epilepsy. His last
seizure was in 2010. He takes anti-seizure

medication. He does not meet the MEP guidelines at this time.
    Kristopher Alan Fraser--Mr. Fraser has a history of epilepsy. His
last seizure was in 2007. He takes anti-seizure medication with a
change in dosage in October 2015. He does not meet the MEP guidelines
at this time.
    Todd A. Fuller--Mr. Fuller has a history of a single seizure in
2014. He takes anti-seizure medication. He does not meet the MEP
guidelines at this time.
    Howard Pearce Hill--Mr. Hill has a history of a seizure disorder.
His last seizure was in 1990. He takes anti-seizure medication with a
change in medication 2015. He does not meet the MEP guidelines at this
time.
    Victor John Martinez--Mr. Martinez has a history of epilepsy. His
last seizure was in 2013. He underwent a left craniotomy and lobectomy
in 2013. He takes anti-seizure medication. He does not meet the MEP
guidelines at this time.
    Sean Michael Monroe--Mr. Monroe has a history of epilepsy. His last
seizure was in 2011. He takes anti-seizure medication. He does not meet
the MEP guidelines at this time.
    Robert H. Philley--Mr. Philley has a history of a seizure disorder.
His last seizure was in 2013. He takes anti-seizure medication. He does
not meet the MEP guidelines at this time.
    David T. Pomianek, Jr.--Mr. Pomianek has a history of epilepsy. His
last seizure was in 2011. He takes anti-seizure medication. He does not
meet the MEP guidelines at this time.
    Gregory Roy Schaefer--Mr. Schaefer has a history of a single
seizure in 2014. He takes anti-seizure medication. He does not meet the
MEP guidelines at this time.
    Maciej Skrzyniarz--Mr. Skrzyniarz has a history of a single seizure
in 2014. He takes anti-seizure medication. He does not meet the MEP
guidelines at this time.

    Issued on: August 26, 2016.
Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2016-21829 Filed 9-9-16; 8:45 am]
 BILLING CODE 4910-EX-P


                  Meeting with PADEP and Pennsylvania sources
                     December 11, 2020 via Microsoft Teams
Purpose: To present and discuss EPA's "Analysis of Pennsylvania Coal EGUs & SCR Operation" with sources in Pennsylvania.
Meeting description: EPA will present information (data analysis) to PADEP and Pennsylvania sources to help inform about source emissions.
 (Presentation attached.)
Attendees:

PA sources
Joseph Kushner
Vince Brisini
John Shimshock
Kevin P. Panzino
Michael Gregorchik
Gary Cline
Lauren Illig
Nathan Rozic
PADEP
Mark Hammond
Naishadh Bhatt
John Krueger
David Clark
Andrew Fleck
Randy Bordner
Kirit Dalal
Vince Pascucci
Sean Wenrich
Douglas Haulik
Krishnan Ramamurthy
Viren Trivedi
USEPA
Michael Gordon
Cristina Fernandez
David Talley
Beth Murray
Reid Harvey
David Lifland
Justine Huetteman
Kaytrue Ting
MaryCate Opila
Jeremy Schreifels
Megan Goold
Maria Pino
Erin Touba
Emily Bertram
Riley Burger
Paul Entwistle
Yongtian He
Justin Leary
Cynthia Stahl
Gwendolyn Supplee
Matthew Willson
Adam Yarina

Other
Bob Paine