Use of Additional Portable Oxygen Concentrator Devices Onboard Aircraft, 53954-53956 [06-7597]

Agencies

• Federal Aviation Administration
• DEPARTMENT OF TRANSPORTATION

[Federal Register Volume 71, Number 176 (Tuesday, September 12, 2006)]
[Rules and Regulations]
[Pages 53954-53956]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 06-7597]



[[Page 53953]]

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Part IV





 Department of Transportation





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 Federal Aviation Administration



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14 CFR Part 121



 Use of Additional Portable Oxygen Concentrator Devices Onboard 
Aircraft; Final Rule

Federal Register / Vol. 71, No. 176 / Tuesday, September 12, 2006 / 
Rules and Regulations

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 121

[Docket No. FAA-2004-18596; SFAR 106]
RIN 2120-AI81


Use of Additional Portable Oxygen Concentrator Devices Onboard 
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 Onboard 
Aircraft, to allow for the use of the AirSep Corporation's FreeStyle, 
SeQual Technologies' Eclipse, and Respironics Inc.'s EverGo portable 
oxygen concentrator (POC) devices onboard aircraft, provided certain 
conditions in the SFAR are met. This action is necessary to allow all 
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 five 
different POC devices the FAA finds acceptable for use onboard aircraft 
during travel, and passengers will be able to carry these devices 
onboard the aircraft and use them with the approval of the aircraft 
operator.

DATES: This final rule amending SFAR 106 will become effective on 
September 12, 2006.

FOR FURTHER INFORMATION CONTACT: David Catey, Air Transportation 
Division, Flight Standards Service, Federal Aviation Administration, 
800 Independence Avenue, SW., Washington, DC 20591. Telephone: (202) 
267-3732.

SUPPLEMENTARY INFORMATION:

Availability of Rulemaking Documents

    You can get an electronic copy using the Internet by:
    (1) Searching the Department of Transportation's electronic Docket 
Management System (DMS) Web page (https://dms.dot.gov/search);
    (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 more 
about SBRFA 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 
procedure 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 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 carriers 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 air carriers and 
suppliers at airports was also difficult, and passengers frequently 
chose not to fly because of these difficulties.
    Recently, new medical oxygen technologies approved by the Food and 
Drug Administration (FDA) reduce the risks typically associated with 
compressed oxygen. 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 POCs 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 onboard aircraft, provided certain conditions for their use are 
met.
    SFAR 106 permits passengers to carry on and use certain POCs 
onboard 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 are the AirSep LifeStyle and 
the Inogen One POCs. Aircraft operators can now offer medical oxygen 
service as they did before SFAR 106 was enacted, or they can arrange 
for passengers to carry on and use one of the 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 devices 
onboard, but they may allow them to be operated onboard. 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 that regulations wouldn't apply to 
specific manufacturers and models of device. Whenever possible, the FAA 
tries to regulate by creating standards rather than approving by 
manufacturer. In the case of SFAR 106, the quickest and easiest way to 
serve both the customer and the air carrier 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 
in 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 SFAR 106 and published it 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 POCs. 
This process is time-consuming

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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 POCs, and 
several have requested that their product also be included as an 
acceptable device in SFAR 106. These new manufacturers include SeQual 
Technologies, Inc., and Respironics, Inc. AirSep Corporation, which 
manufactures the LifeStyle POC authorized for use under SFAR 106, has 
asked the FAA to authorize the use of its FreeStyle POC under SFAR 106 
also. Each of these companies has formally petitioned the FAA for 
inclusion in SFAR 106 by submitting documentation of the devices to the 
Department of Transportation's Docket Management System. That 
documentation is available at https://dmes.dot.gov under the following 
docket numbers:
    1. SeQual Technologies--FAA-2005-22574.
    2. Respironics Inc., formerly OxyTec Medical Corporation--FAA-2006-
23678.
    3. AirSep Corporation--FAA-2006-24912.
    As stated in Section 2 of SFAR 106, each covered device must not 
contain hazardous materials as determined by PHMSA (written 
documentation necessary), and 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. SeQual Technologies' Eclipse Oxygen System;
    2. Respironics EverGo System; and
    3. AirSep Corporation's FreeStyle Portable Oxygen Concentrator.

The Rule

    This amendment to SFAR 106 will include the SeQual Eclipse, 
Respironics EverGo, and AirSep FreeStyle devices in the list of POCs 
authorized for use in air commerce. The FAA has reviewed each 
individual device and accepted the documentation provided by the three 
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 three devices were determined by the FAA to be 
acceptable for use in air commerce.
    Along with the inclusion of these three new devices in Section 2 of 
the SFAR, we amend the rule by removing the requirement that a POC 
provide oxygen therapy solely through the use of pulse technology. It 
was only after publication of SFAR 106 that we learned about a 
continuous flow feature of the SeQual Technologies Eclipse POC. The 
Eclipse POC features pulse delivery in addition to its continuous flow 
feature. Therefore, we find there is no safety reason for limiting POC 
acceptance to those POCs having only the pulse delivery feature. That 
requirement was formerly included in Section 2 of the SFAR and has been 
removed.

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 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 onboard 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 not in the public interest to publish a notice to 
request comments on this amendment because all issues related to the 
use of POC devices onboard an aircraft have already been discussed. 
Further notice and comment would unnecessarily delay the acceptance of 
the AirSep FreeStyle, SeQual Eclipse, and Respironics EverGo POC 
devices as authorized for use onboard aircraft and included in SFAR 
106.
    Therefore, I find that notice and public comment under 5 U.S.C. 
553(b) are impracticable 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 proposed 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 this final rule 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 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 three 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

    Executive Order 12866, Regulatory Planning and Review, directs the 
FAA to assess both the costs and benefits of a regulatory change. We 
are not allowed to propose or adopt a regulation unless we make a 
reasoned determination that the benefits of the intended regulation 
justify its costs. Our assessment of this proposal indicates that its 
economic impact is minimal. Since its costs and benefits do not make it 
a ``significant regulatory action'' as defined in the Order, we have 
not prepared a ``regulatory impact analysis.'' Similarly, we have not 
prepared a ``regulatory evaluation,'' which is the written cost/benefit 
analysis ordinarily required for all rulemaking proposals under the DOT

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Regulatory and Policies and Procedures. We do not need to do the latter 
analysis where the economic impact of a proposal is minimal. This final 
rule amending SFAR 106 has no new costs associated with it because 
there is no requirement for use of these devices. The regulatory 
evaluation presented when SFAR 106 was first published is still valid 
and applicable, and the inclusion of these three devices as options for 
passengers and operators does not change the cost or benefits assigned 
in that final rule.

Regulatory Flexibility Determination

    The Regulatory Flexibility Act of 1980 (RFA) directs the FAA to fit 
regulatory requirements to the scale of the business, organizations, 
and governmental jurisdictions subject to the regulation. We are 
required to determine whether a proposed or final action will have a 
``significant economic impact on a substantial number of small 
entities'' as they are defined in the Act. If we find that the action 
will have a significant impact, we must do a ``regulatory flexibility 
analysis.''
    This final rule adds three new devices to the list of authorized 
POCs in SFAR 106. Its economic impact is minimal. Therefore, I certify 
that this action will not have a significant economic impact on a 
substantial number of small entities.

Trade Impact Assessment

    The Trade Agreements Act of 1979 prohibits Federal agencies from 
engaging in any standards or related activities that create unnecessary 
obstacles to the foreign commerce of the United States. Legitimate 
domestic objectives, such as safety, are not considered unnecessary 
obstacles. The statute also requires consideration of international 
standards and where appropriate, that they be the basis for U.S. 
standards. In addition, consistent with the Administration's belief in 
the general superiority and desirability of free trade, it is the 
policy of the Administration to remove or diminish to the extent 
feasible, barriers to international trade, including both barriers 
affecting the export of American goods and services to foreign 
countries and barriers affecting the import of foreign goods and 
services into the United States.
    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 costs 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) 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 an expenditure of $100 million or more (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 $128.1 million in lieu of $100 
million.
    This final rule does not contain such a mandate. The requirements 
of Title II of the Act, therefore, 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.

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 proposed rulemaking action qualifies for the 
categorical exclusion identified in paragraph 312d 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.

List of Subjects in 14 CFR Part 121

    Air carriers, Aircraft, Airmen, Aviation safety, Charter flights, 
Safety, Transportation, Air taxis.

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. Revise Section 2 of SFAR 106 to read as follows:
* * * * *
    Section 2. Definitions--For the purposes of this SFAR the following 
definitions apply: Portable Oxygen Concentrator: means the AirSep 
LifeStyle, AirSep FreeStyle, Inogen One, SeQual Eclipse, or Respironics 
EverGo 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.
* * * * *

0
3. Revise Section 3(a) introductory text of SFAR 106 to read as 
follows:
    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 LifeStyle, 
AirSep FreeStyle, Inogen One, SeQual Eclipse, or Respironics EverGo 
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 August 18, 2006.
Marion C. Blakey,
Administrator.
[FR Doc. 06-7597 Filed 9-11-06; 8:45 am]
BILLING CODE 4910-13-P