Document ID: FAA-2009-1059-0002
Agency: faa
Document Type: Rule
Title: Use of One Additional Portable Oxygen Concentrator Device on Board Aircraft
Posted Date: 2010-07-12T04:00Z

[Federal Register: July 12, 2010 (Volume 75, Number 132)]
[Rules and Regulations]               
[Page 39629-39632]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr12jy10-2]                         

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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]
BILLING CODE 4910-13-P