Federal Register, Volume 75 Issue 132 (Monday, July 12, 2010)

[Federal Register Volume 75, Number 132 (Monday, July 12, 2010)]
[Rules and Regulations]
[Pages 39629-39632]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-16925]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 121

[Docket No.: FAA-2009-1059; SFAR 106]
RIN 2120-AJ77

Use of One Additional Portable Oxygen Concentrator Device on
Board Aircraft

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: This action amends Special Federal Aviation Regulation 106
(SFAR 106), Rules for Use of Portable Oxygen Concentrator Systems on
Board Aircraft, to allow for the use of one additional portable oxygen
concentrator (POC) device on board aircraft, provided certain
conditions in the SFAR are met. This action is necessary to allow all
POC devices deemed acceptable by the FAA for use in air commerce to be
available to the traveling public in need of oxygen therapy. When this
rule becomes effective, there will be 12 different POC devices the FAA
finds acceptable for use on board aircraft. Passengers will be able to
carry these devices on board the aircraft and use them with the
approval of the aircraft operator.

DATES: This amendment becomes effective July 12, 2010.

FOR FURTHER INFORMATION CONTACT: DK Deaderick, Air Transportation
Division, Flight Standards Service, Federal Aviation Administration,
800 Independence Avenue, SW., Washington, DC 20591. Telephone: 202-267-
8166.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code (49 U.S.C.). 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 authorized to issue this final rule pursuant to 49
U.S.C. 44701. Under that section, the FAA is authorized to establish
regulations and minimum standards for other practices, methods, and
procedures the Administrator finds necessary for air commerce and
national security.

Background

On July 12, 2005, the FAA published Special Federal Aviation
Regulation 106 (SFAR 106) entitled, ``Use of Certain Portable Oxygen
Concentrator Devices Onboard Aircraft'' (70 FR 40156). SFAR 106 is the
result of a notice the FAA published in July 2004 (69 FR 42324) to
address the needs of passengers who

[[Page 39630]]

must travel with medical oxygen. Before publication of SFAR 106,
passengers in need of medical oxygen during air transportation faced
many obstacles when requesting service. Many aircraft operators did not
provide medical oxygen service aboard flights, and those that did often
provided service at a price that travelers could not afford.
Coordinating service between operators and suppliers at airports was
also difficult, and passengers frequently chose not to fly because of
these difficulties.
New medical oxygen technologies approved by the Food and Drug
Administration (FDA) reduce the risks typically associated with
compressed oxygen and provide a safe alternative for passengers who
need oxygen therapy. Several manufacturers have developed small
portable oxygen concentrators (POC) that work by separating oxygen from
nitrogen and other gases contained in ambient air and dispensing it in
concentrated form to the user with an oxygen concentration of about
90%. The POCs operate using either rechargeable batteries or, if the
aircraft operator obtains approval from the FAA, aircraft electrical
power.
In addition, the Pipeline and Hazardous Materials Safety
Administration (PHMSA) has determined that the POC covered by this
amendment is not a hazardous material. Thus, it does not require the
same level of special handling as compressed oxygen, and is safe for
use on board aircraft, provided certain conditions for its use are met.
SFAR 106 permits passengers to carry on and use certain POCs on
board aircraft if the aircraft operator ensures that the conditions
specified in the SFAR for their use are met. The devices initially
determined acceptable for use in SFAR 106, published July 12, 2005,
were the AirSep Corporation's LifeStyle and the Inogen, Inc.'s Inogen
One POCs. SFAR 106 was amended on September 12, 2006, (71 FR 53954) to
add three additional POC devices, AirSep Corporation's FreeStyle,
SeQual Technologies' Eclipse, and Respironics Inc.'s EverGo, to the
original SFAR. SFAR 106 was amended on January 15, 2009, (74 FR 2351)
in a similar manner to add two more POC devices, Delphi Medical
Systems' RS-00400 and Invacare Corporation's XPO2, to the original
SFAR. The FAA again amended SFAR 106 on January 6, 2010 (75 FR 739) to
add four more POC devices, DeVilbiss Healthcare Inc.'s iGo,
International Biophysics Corporation's LifeChoice, Inogen Inc.'s Inogen
One G2, and Oxlife LLC.'s Oxlife Independence Oxygen Concentrator, that
may be carried on and used by a passenger on board an aircraft. This
final rule adds one more POC device, Invacare SOLO2, that may be
carried on and used by a passenger on board an aircraft.
Aircraft operators can now offer medical oxygen service as they did
before SFAR 106 was enacted, or they can meet certain conditions and
allow passengers to carry on and use one of the POC devices covered in
SFAR 106. SFAR 106 is an enabling rule, which means that no aircraft
operator is required to allow passengers to operate these POC devices
on board its aircraft, but it may allow them to be operated on board.
If one of these devices is allowed by the aircraft operator to be
carried on board, the conditions in the SFAR must be met.
When SFAR 106 was published, the FAA committed to establishing a
single standard for all POCs so the regulations wouldn't apply to
specific manufacturers and models of device. Whenever possible, the FAA
tries to regulate by creating performance-based standards rather than
approving by manufacturer. In the case of SFAR 106, the most efficient
way to serve both the passenger and the aircraft operator was to allow
the use of the devices determined to be acceptable by the FAA in SFAR
106 in a special, temporary regulation. As the FAA stated in the
preamble discussion of the final rule that established SFAR 106,
``while we are committed to developing a performance-based standard for
all future POC devices, we do not want to prematurely develop standards
that have the effect of stifling new technology of which we are
unaware.'' The FAA developed and published SFAR 106 so passengers who
otherwise could not fly could do so with an affordable alternative to
what existed before SFAR 106 was published.
The FAA continues to pursue the performance-based standard for all
POCs. This process is time-consuming, and the FAA intends to publish a
notice in the Federal Register and offer the public a chance to comment
on the proposal when it is complete. In the meantime, manufacturers
continue to create new and better POCs, and one has requested that its
product also be included as an acceptable device in SFAR 106. This
manufacturer is Invacare Corporation, which has formally petitioned the
FAA for inclusion in SFAR 106 by submitting documentation of the device
to the Department of Transportation's Docket Management System. That
documentation is available at http://www.regulations.gov under docket
number: FAA-2009-1059.
As stated in Section 2 of SFAR 106, no covered device may contain
hazardous materials as determined by PHMSA (written documentation
necessary), and each device must also be regulated by the FDA. Invacare
Corporation included technical specifications for the devices in its
request for approval and the required documentation from PHMSA and the
FDA. Invacare Corporation provided the FAA with the required
documentation for the Invacare SOLO2 device.

The Rule

This amendment to SFAR 106 will include the Invacare SOLO2 device
in the list of POC devices authorized for use in air commerce. The FAA
has reviewed the device and accepted the documentation provided by the
manufacturer. That documentation includes letters provided to the
manufacturer by PHMSA and the FDA affirming the status of the device as
it applies to the requirements stated in SFAR 106. After reviewing the
applicable FDA safety standards and the PHMSA findings, the device was
determined by the FAA to be acceptable for use in air commerce.
Additionally, the FAA inadvertently included an incorrect model
number reference for one POC device in SFAR 106 that was added on
January 15, 2009 (74 FR 2351). Therefore, the FAA is changing the
reference from ``Invacare XPO100'' to ``Invacare XP02.''

Good Cause for Adoption of This Final Rule Without Notice and Comment

SFAR 106 was published on July 12, 2005. The FAA stated in the
preamble of that final rule that the AirSep LifeStyle and Inogen One
POC devices were the only known acceptable devices when the rule was
published. The FAA also stated in that final rule that ``we cannot
predict how future products may be developed and work.'' The FAA
initiated a notice and comment period for the use of POC devices on
board aircraft on July 14, 2004, (69 FR 42324) and responded to the
comments received in response to that NPRM in the final rule published
in 2005. Therefore, it is unnecessary to publish a notice to request
comments on this amendment because all issues related to the use of POC
devices on board an aircraft have already been discussed. Further
notice and comment would also delay the acceptance of the Invacare
SOLO2 POC device as authorized for use on board aircraft, which would
delay its availability for passengers in need of oxygen therapy.
Therefore, I find that notice and public comment under 5 U.S.C.
553(b)

[[Page 39631]]

is unnecessary and contrary to the public interest. Further, I find
that good cause exists for making this rule effective immediately upon
publication.

Paperwork Reduction Act

Information collection requirements associated with this final rule
have been approved previously by the Office of Management and Budget
(OMB) under the provisions of the Paperwork Reduction Act of 1995 (44
U.S.C. 3507(d)) and have been assigned OMB Control Number 2120-0702.
This final rule requires that if a passenger carries a POC device on
board the aircraft with the intent to use it during the flight, he or
she must inform the pilot in command of that flight. Additionally, the
passenger who plans to use the device must provide a written statement
signed by a licensed physician that verifies the passenger's ability to
operate the device, respond to any alarms, the extent to which the
passenger must use the POC (all or a portion of the flight), and
prescribes the maximum oxygen flow rate. The Paperwork Reduction Act
paragraph in the final rule that established SFAR 106 still applies to
this amendment. The availability of a new POC device will likely
increase the availability and options for a passenger in need of oxygen
therapy, but the paperwork burden discussed in the original final rule
is unchanged. Therefore, the OMB Control Number associated with this
collection remains 2120-0702.
An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information unless it displays a
currently valid OMB control number.

International Compatibility

In keeping with U.S. obligations under the Convention on
International Civil Aviation, it is FAA policy to conform to
International Civil Aviation Organization (ICAO) Standards and
Recommended Practices to the maximum extent practicable. The FAA has
determined that there are no ICAO Standards and Recommended Practices
that correspond to these regulations.

Regulatory Evaluation, Regulatory Flexibility Determination,
International Trade Impact Assessment, and Unfunded Mandates Assessment

Changes to Federal regulations must undergo several economic
analyses. First, Executive Order 12866 directs that each Federal agency
shall propose or adopt a regulation only upon a reasoned determination
that the benefits of the intended regulation justify its costs. Second,
the Regulatory Flexibility Act of 1980 (Pub. L. 96-354) requires
agencies to analyze the economic impact of regulatory changes on small
entities. Third, the Trade Agreements Act (Pub. L. 96-39) prohibits
agencies from setting standards that create unnecessary obstacles to
the foreign commerce of the United States. In developing U.S.
standards, this Trade Act requires agencies to consider international
standards and, where appropriate, that they be the basis of U.S.
standards. Fourth, the Unfunded Mandates Reform Act of 1995 (Pub. L.
104-4) requires agencies to prepare a written assessment of the costs,
benefits, and other effects of proposed or final rules that include a
Federal mandate likely to result in the expenditure by State, local, or
tribal governments, in the aggregate, or by the private sector, of $100
million or more annually (adjusted for inflation with base year of
1995). This portion of the preamble summarizes the FAA's analysis of
the economic impacts of this final rule.
Department of Transportation Order DOT 2100.5 prescribes policies
and procedures for simplification, analysis, and review of regulations.
If the expected cost impact is so minimal that a proposed or final rule
does not warrant a full evaluation, this order permits that a statement
to that effect and the basis for it be included in the preamble if a
full regulatory evaluation of the cost and benefits is not prepared.
Such a determination has been made for this final rule. The reasoning
for this determination follows:
This action amends SFAR 106 to allow for the use of the Invacare
SOLO2 POC device on board aircraft, provided certain conditions in the
SFAR are met. This action is necessary to allow an additional POC
device deemed acceptable by the FAA to be available to the traveling
public in need of oxygen therapy, for use in air commerce. When this
rule becomes effective, there will be a total of 12 different POC
devices the FAA finds acceptable for use on board aircraft, and
passengers will be able to carry these devices on board the aircraft
and use them with the approval of the aircraft operator. As the rule
increases acceptable POC devices on board aircraft, the rule does not
increase costs and provides additional benefits. The FAA has,
therefore, determined that this final rule is not a ``significant
regulatory action'' as defined in section 3(f) of Executive Order
12866, and is not ``significant'' as defined in DOT's Regulatory
Policies and Procedures.

Regulatory Flexibility Determination

The Regulatory Flexibility Act of 1980 (Pub. L. 96-354) (RFA)
establishes ``as a principle of regulatory issuance that agencies shall
endeavor, consistent with the objectives of the rule and of applicable
statutes, to fit regulatory and informational requirements to the scale
of the businesses, organizations, and governmental jurisdictions
subject to regulation. To achieve this principle, agencies are required
to solicit and consider flexible regulatory proposals and to explain
the rationale for their actions to assure that such proposals are given
serious consideration.'' The RFA covers a wide-range of small entities,
including small businesses, not-for-profit organizations, and small
governmental jurisdictions.
Agencies must perform a review to determine whether a rule will
have a significant economic impact on a substantial number of small
entities. If the agency determines that it will, the agency must
prepare a regulatory flexibility analysis as described in the RFA.
However, if an agency determines that a rule is not expected to
have a significant economic impact on a substantial number of small
entities, section 605(b) of the RFA provides that the head of the
agency may so certify and a regulatory flexibility analysis is not
required. The certification must include a statement providing the
factual basis for this determination, and the reasoning should be
clear.
This final rule adds Invacare SOLO2 device to the list of
authorized POC devices in SFAR 106. This economic impact is minimal.
Therefore, as the FAA Administrator, I certify that this action will
not have a significant economic impact on a substantial number of small
entities.

Unfunded Mandates Reform Act

Title II of the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-
4) requires each Federal agency to prepare a written statement
assessing the effects of any Federal mandate in a proposed or final
agency rule that may result in an expenditure of $100 million or more
(in 1995 dollars) in any one year by State, local, and tribal
governments, in the aggregate, or by the private sector; such a mandate
is deemed to be a ``significant regulatory action.'' The FAA currently
uses an inflation-adjusted value of $143.1 million in lieu of $100
million.
This final rule does not contain such a mandate; therefore, the
requirements of Title II of the Act do not apply.

Executive Order 13132, Federalism

The FAA has analyzed this final rule under the principles and
criteria of Executive Order 13132, Federalism. The FAA determined that
this action will

[[Page 39632]]

not have a substantial direct effect on the States, or the relationship
between the Federal Government and the States, or on the distribution
of power and responsibilities among the various levels of government.
Therefore, the FAA has determined that this final rule does not have
federalism implications.

Environmental Analysis

FAA Order 1050.1E identifies FAA actions that are categorically
excluded from preparation of an environmental assessment or
environmental impact statement under the National Environmental Policy
Act in the absence of extraordinary circumstances. The FAA has
determined this rulemaking action qualifies for the categorical
exclusion identified in paragraph 312f and involves no extraordinary
circumstances.

Regulations That Significantly Affect Energy Supply, Distribution, or
Use

The FAA analyzed this final rule under Executive Order 13211,
Actions Concerning Regulations that Significantly Affect Energy Supply,
Distribution, or Use (May 18, 2001). The FAA has determined that it is
not a ``significant energy action'' under the executive order because
it is not a ``significant regulatory action'' and it is not likely to
have a significant adverse effect on the supply, distribution, or use
of energy.

Availability of Rulemaking Documents

You can get an electronic copy using the Internet by:
(1) Searching the Federal eRulemaking Portal at http://www.regulations.gov;
(2) Visiting the FAA's Regulations and Policies Web page at http://www.faa.gov/regulations_policies/; or
(3) Accessing the Government Printing Office's Web page at http://www.gpoaccess.gov/fr/index.html.
You can also get a copy by sending a request to the Federal
Aviation Administration, Office of Rulemaking, ARM-1, 800 Independence
Avenue, SW., Washington, DC 20591, or by calling (202) 267-9680. Make
sure to identify the amendment number or docket number of this
rulemaking.

Small Business Regulatory Enforcement Fairness Act

The Small Business Regulatory Enforcement Fairness Act (SBREFA) of
1996 requires FAA to comply with small entity requests for information
or advice about compliance with statutes and regulations within its
jurisdiction. Therefore, any small entity that has a question regarding
this document may contact its local FAA official, or the person listed
under FOR FURTHER INFORMATION CONTACT. You can find out more about
SBREFA on the Internet at http://www.faa.gov/regulations_policies/rulemaking/sbre_act/.

List of Subjects in 14 CFR Part 121

Air carriers, Aircraft, Airmen, Reporting and recordkeeping
requirements.

The Amendment

0
In consideration of the foregoing, the Federal Aviation Administration
amends SFAR No. 106 to Chapter II of Title 14, Code of Federal
Regulations, as follows:

PART 121--OPERATING REQUIREMENTS: DOMESTIC, FLAG, AND SUPPLEMENTAL
OPERATIONS

0
1. The authority citation for part 121 continues to read as follows:

Authority: 49 U.S.C. 106(g), 1153, 40101, 40102, 40103, 40113,
41721, 44105, 44106, 44111, 44701-44717, 44722, 44901, 44903, 44904,
44906, 44912, 44914, 44936, 44938, 46103, 46105.

0
2. Amend SFAR 106 by revising sections 2 and 3(a) introductory text to
read as follows:

Special Federal Aviation Regulation 106--Rules for use of Portable
Oxygen Concentrator Systems on Board Aircraft

* * * * *
Section 2. Definitions--For the purposes of this SFAR the
following definitions apply: Portable Oxygen Concentrator: means the
AirSep FreeStyle, AirSep LifeStyle, Delphi RS-00400, DeVilbiss
Healthcare iGo, Inogen One, Inogen One G2, International Biophysics
LifeChoice, Invacare XPO2, Invacare Solo2, Oxlife Independence
Oxygen Concentrator, Respironics EverGo, and SeQual Eclipse Portable
Oxygen Concentrator medical device units as long as those medical
device units: (1) Do not contain hazardous materials as determined
by the Pipeline and Hazardous Materials Safety Administration; (2)
are also regulated by the Food and Drug Administration; and (3)
assist a user of medical oxygen under a doctor's care. These units
perform by separating oxygen from nitrogen and other gases contained
in ambient air and dispensing it in concentrated form to the user.
Section 3. Operating Requirements--
(a) No person may use and no aircraft operator may allow the use
of any portable oxygen concentrator device, except the AirSep
FreeStyle, AirSep LifeStyle, Delphi RS-00400, DeVilbiss Healthcare
iGo, Inogen One, Inogen One G2, International Biophysics LifeChoice,
Invacare XPO2, Invacare Solo2, Oxlife Independence Oxygen
Concentrator, Respironics EverGo, and SeQual Eclipse Portable Oxygen
Concentrator units. These units may be carried on and used by a
passenger on board an aircraft provided the aircraft operator
ensures that the following conditions are satisfied:
* * * * *

Issued in Washington, DC, on July 1, 2010.
J. Randolph Babbitt,
Administrator.
[FR Doc. 2010-16925 Filed 7-9-10; 8:45 am]
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