Use of Additional Portable Oxygen Concentrator Devices On Board Aircraft, 2351-2355 [E9-790]

Agencies

• Federal Aviation Administration
• DEPARTMENT OF TRANSPORTATION

[Federal Register Volume 74, Number 10 (Thursday, January 15, 2009)]
[Rules and Regulations]
[Pages 2351-2355]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-790]


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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 121

[Docket No. FAA-2008-1227; SFAR 106]
RIN 2120-AJ40


Use of Additional Portable Oxygen Concentrator Devices 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), Use of Certain Portable Oxygen Concentrator Devices On 
Board Aircraft, to allow for the use of the Delphi Medical Systems' RS-
00400 and Invacare Corporation's XPO2 portable oxygen concentrator 
(POC) devices on board aircraft, provided certain conditions in the 
SFAR are met. SFAR 106 was previously amended to add three additional 
POC devices to the original SFAR. Today's action is necessary to allow 
all POC devices deemed acceptable by the FAA to be available for use in 
air commerce to the traveling public in need of oxygen therapy. With 
this Final Rule, there will be a total of seven 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.

DATES: This final rule amending SFAR 106 will become effective on 
January 15, 2009.

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

SUPPLEMENTARY INFORMATION: 

Availability of Rulemaking Documents

    You can get an electronic copy using the Internet by:
    (1) Searching the Federal eRulemaking Portal at https://
www.regulations.gov;
    (2) Visiting the FAA's Regulations and Policies Web page at https://
www.faa.gov/regulations_policies/; or
    (3) Accessing the Government Printing Office's Web page at https://
www.gpoaccess.gov/fr/.
    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 their local FAA official, or the person 
listed under FOR FURTHER INFORMATION CONTACT. You can find out

[[Page 2352]]

more about SBREFA on the Internet at our site, https://www.faa.gov/
regulations_policies/rulemaking/sbre_act/.

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 On Board Aircraft'' (70 FR 40156). SFAR 106 is the 
result of a notice of proposed rulemaking (NPRM) the FAA published in 
July 2004 (69 FR 42324) to address the needs of passengers who must 
travel with medical oxygen. Prior to 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 concentrator (POC) devices 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 POC devices 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 devices covered by 
this amendment are not hazardous materials. Thus, they do not require 
the same level of special handling as compressed oxygen, and are safe 
for use on board aircraft, provided certain conditions for their use 
are met.
    SFAR 106 permits passengers to carry on and use certain POC devices 
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 Repironics Inc.'s EverGo, to the 
original SFAR. This final rule adds two additional POC devices, Delphi 
Medical Systems' RS-00400 and Invacare Corporation's XPO2, 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 the aircraft operator allows one of these devices to be carried on 
board, the conditions in the SFAR must be met.
    When SFAR 106 was originally published, the FAA committed to 
establishing a single standard for all POC devices so that regulations 
would not apply to specific manufacturers and models of devices. 
Whenever possible, the FAA tries to regulate by creating performance-
based standards rather than approving specific devices by manufacturer. 
In the case of SFAR 106, the quickest and easiest 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 we 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.'' We developed and 
published SFAR 106 so that passengers who otherwise could not fly could 
do so with an affordable alternative to what existed before SFAR 106 
was published.
    We continue to pursue the performance-based standard for all POC 
devices. This process is time-consuming and we intend 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 POC devices, and several have 
requested that their product also be included as an acceptable device 
in SFAR 106. These new manufacturers include Delphi Medical Systems and 
Invacare Corporation. Each of these companies has formally petitioned 
the FAA for inclusion in SFAR 106 by submitting documentation of the 
devices to the Federal Docket Management System. That documentation is 
available at https://www.regulations.gov under the following docket 
numbers:
    1. Delphi Medical Systems--FAA-2008-0261; and
    2. Invacare Corporation--FAA-2008-0278.
    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. Each 
petitioner included technical specifications for the devices in their 
request for approval, along with the required documentation from PHMSA 
and the FDA. The petitioners provided the FAA with the required 
documentation for the following POC devices:
    1. Delphi Medical Systems', Model RS-00400; and
    2. Invacare Corporation's, Model XPO2.

The Rule

    This amendment to SFAR 106 will include the Delphi Medical Systems' 
RS-00400 and Invacare Corporation's XPO2 devices in the list of POC 
devices authorized for use in air commerce. The FAA has reviewed each 
individual device and accepted the documentation provided by the two 
manufacturers. That documentation includes letters provided to the 
manufacturer by PHMSA and the FDA affirming the status of each device 
as it pertains to the requisites stated in SFAR 106.
    After reviewing the applicable FDA safety standards and the PHMSA 
findings, these two devices were determined by the FAA to be acceptable 
for use in air commerce.

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

    As stated above, SFAR 106 was published on July 12, 2005. We stated 
in the preamble of that final rule that

[[Page 2353]]

the AirSep LifeStyle and Inogen One POC devices were the only known 
acceptable devices when the rule was published. We also stated in that 
final rule that ``we cannot predict how future products may be 
developed and work.'' We 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 Delphi Medical Systems' RS-00400 and Invacare Corporation's XPO2 
POC devices as authorized for use on board aircraft, which would delay 
their availability for passengers in need of oxygen therapy.
    Therefore, I find that notice and public comment under 5 U.S.C. 
553(b) is unnecessary and contrary to the public interest. Further, I 
find that good cause exists for making this rule effective immediately 
upon publication.

International Compatibility

    In keeping with U.S. obligations under the Convention on 
International Civil Aviation, it is FAA policy to comply with 
International Civil Aviation Organization (ICAO) Standards and 
Recommended Practices to the maximum extent practicable. The FAA 
determined that there are no ICAO Standards and Recommended Practices 
that correspond to these regulations. I find that this action is fully 
consistent with my obligations under 49 U.S.C. 40105(b)(1)(A) to ensure 
that I exercise my duties consistently with the obligations of the 
United States under international agreements.

Paperwork Reduction Act

    As required by the Paperwork Reduction Act of 1995 (44 U.S.C. 
3507(d)), the FAA submitted a copy of the new information collection 
requirements in SFAR 106 to the Office of Management and Budget for its 
review. OMB approved the collection of this information and 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.
    Please note that 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. The Paperwork Reduction 
Act paragraph in the final rule that established SFAR 106 still applies 
to this amendment. The availability of two new POC devices 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.

Regulatory Analyses

Executive Order 12866 and DOT Regulatory Policies and Procedures

    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, the Trade Agreements 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 to 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 Special Federal Aviation Regulation 106 (SFAR 
106), Use of Certain Portable Oxygen Concentrator Devices On Board 
Aircraft, to allow for the use of the Delphi Medical Systems' RS-00400 
and Invacare Corporation's XPO2 portable oxygen concentrator (POC) 
devices on board aircraft, provided certain conditions in the SFAR are 
met. This action is necessary to allow additional POC devices 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 seven 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.
    The FAA has 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

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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 Delphi Medical Systems' RS-00400 and Invacare 
Corporation's XPO2 to the list of authorized POC devices in SFAR 106. 
Its economic impact is minimal. Therefore, as the Acting FAA 
Administrator, I certify that this action will not have a significant 
economic impact on a substantial number of small entities.

International Trade Analysis

    The Trade Agreements Act of 1979 (Pub. L. 96-39), as amended by the 
Uruguay Round Agreements Act (Pub. L. 103-465), prohibits Federal 
agencies from establishing any standards or engaging in related 
activities that create unnecessary obstacles to the foreign commerce of 
the United States. Pursuant to these Acts, the establishment of 
standards are not considered unnecessary obstacles to the foreign 
commerce of the United States, so long as the standards have a 
legitimate domestic objective, such the protection of safety, and do 
not operate in a manner that excludes imports that meet this objective. 
The statute also requires consideration of international standards and, 
where appropriate, that they be the basis for U.S. standards. The FAA 
notes the purpose is to ensure the safety of the American public, and 
has assessed the effects of this rule to ensure that it does not 
exclude imports that meet this objective. As a result, this rule is not 
considered as creating an unnecessary obstacle to foreign commerce.
    In accordance with the above statute and policy, the FAA has 
assessed the potential effect of this final rule and has determined 
that it will impose the same minimal impact on domestic and 
international entities and thus has a neutral trade impact.

Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (the Act), enacted as 
Public Law 104-4 on March 22, 1995, is intended, among other things, to 
curb the practice of imposing unfunded Federal mandates on State, 
local, and tribal governments. Title II of the Act 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 a $100 million or more expenditure (adjusted annually for inflation) 
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 $136.1 million in lieu of $100 million.
    This final rule does not contain such a mandate. Therefore, the 
requirements of Title II of the Unfunded Mandates Reform Act of 1995 do 
not apply.

Executive Order 13132, Federalism

    The FAA has analyzed this final rule under the principles and 
criteria of Executive Order 13132, Federalism. We determined that this 
action will not have a substantial direct effect on the States, or the 
relationship between the national Government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government. Therefore, we have determined that this final rule does not 
have federalism implications.

Plain Language

    In response to the June 1, 1998 Presidential Memorandum regarding 
the use of plain language, the FAA re-examined the writing style 
currently used in the development of regulations. The memorandum 
requires federal agencies to communicate clearly with the public. We 
are interested in your comments on whether the style of this document 
is clear, and in any other suggestions you might have to improve the 
clarity of FAA communications that affect you. You can get more 
information about the Presidential memorandum and the plain language 
initiative at http//:www.plainlanguage.gov.

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 has analyzed this final rule under Executive Order 13211, 
Actions Concerning Regulations that Significantly Affect Energy Supply, 
Distribution, or Use (66 FR 28355; May 18, 2001). We have determined 
that it is not a ``significant energy action'' under the executive 
order because it is not a ``significant regulatory action'' under 
Executive Order 12866, and it is not likely to have a significant 
adverse effect on the supply, distribution, or use of energy.

The Amendment

    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, Inogen One, Invacare 
XPO2, Respironics EverGo, and SeQual Eclipse Portable Oxygen 
Concentrator medical devices as long as those medical devices: (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, Inogen One, Invacare XPO2, 
Respironics EverGo, or SeQual Eclipse Portable Oxygen Concentrator 
devices. These devices may be carried on and used by a passenger on 
board an aircraft provided the aircraft operator ensures that the 
following conditions are satisfied:
* * * * *


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    Issued in Washington, DC on January 7, 2009.
Robert Sturgell,
Acting Administrator.
 [FR Doc. E9-790 Filed 1-14-09; 8:45 am]
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