Use of Additional Portable Oxygen Concentrators on Board Aircraft, 63217-63221 [2012-25412]

Agencies

• Federal Aviation Administration
• DEPARTMENT OF TRANSPORTATION

[Federal Register Volume 77, Number 200 (Tuesday, October 16, 2012)]
[Rules and Regulations]
[Pages 63217-63221]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-25412]


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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 121

[Docket No. FAA-2012-0928; Amdt. No. 121-361]
RIN 2120-AK18


Use of Additional Portable Oxygen Concentrators on Board Aircraft

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: This action amends the FAA's rules for permitting limited use 
of portable oxygen concentrator systems on board aircraft, to allow for 
the use of additional portable oxygen concentrator (POC) devices 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

[[Page 63218]]

traveling public in need of oxygen therapy. Passengers will be able to 
carry these devices on board the aircraft and use them with the 
approval of the aircraft operator.

DATES: Effective October 31, 2012.

FOR FURTHER INFORMATION CONTACT: For technical questions concerning 
this action, contact DK Deaderick, Air Transportation Division, AFS-
200, Flight Standards Service, Federal Aviation Administration, 800 
Independence Avenue SW., Washington, DC 20591; telephone 202-167-8166; 
email DK.Deaderick@faa.gov.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

    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 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.
    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. Numerous 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 material. 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 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 AirSep Corporation's LifeStyle and Inogen, Inc.'s Inogen One POCs. 
SFAR 106 has been amended several times to allow passengers to use 
additional devices. This final rule adds additional POC devices, 
including AirSep Corporation's Focus, AirSep FreeStyle 5, Inogen One 
G3, Inova Labs, Inc.'s LifeChoice Activox, Phillips Respironics Simply 
Go, Precision Medical Inc.'s EasyPulse and SeQual Technologies, Inc.'s 
SAROS that may be carried on and used by a passenger on board an 
aircraft.
    In addition, on January 27, 2012 (77 FR 4219), the FAA published a 
Technical Amendment to update the names of two approved POC 
manufacturers due to business changes. The LifeChoice POC is currently 
being manufactured by Inova Labs, Inc. and the RS-00400 POC is 
currently being manufactured by Oxus, Inc. In the technical amendment, 
the FAA inadvertently removed the previous manufacturer's names from 
the list of approved POCs in SFAR 106. People still have POCs marked 
with those manufacturer's names. In this final rule, the FAA will add 
those previous manufacturer's names (International Biophysics 
Corporation's LifeChoice and Delphi Medical Systems' RS-00400) back to 
the list of approved POCs in SFAR 106.
    Aircraft operators 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 operated on 
board, the conditions in the SFAR must be met.
    When SFAR 106 was published, the FAA committed to establishing a 
single performance 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 manufacturers have 
requested that their product also be included as an acceptable POC in 
SFAR 106. Precision Medical, Inc., Inogen, Inc. and AirSep Corporation 
have formally submitted petitions for exemption to the FAA that would 
allow their POCs to be used on aircraft. In addition, SeQual 
Technologies, Inc., Inova Labs, Inc., and Phillips Respironics have 
submitted requests for approval and addition to SFAR 106, with all 
required documentation for their POCs, to the Department of 
Transportation's Docket Management System.
    Additionally, 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. All manufacturers have included technical specifications for their 
devices in each request for approval, as well as the required 
documentation from PHMSA and the FDA.

The Rule

    This amendment to SFAR 106 will include the AirSep Focus, AirSep 
FreeStyle 5, Inogen One G3, Inova Labs LifeChoice Activox, Respironics 
Simply Go, Precision Medical EasyPulse and SeQual SAROS devices in the 
list of POC devices authorized for use in air commerce. The FAA has 
reviewed these devices and accepted the

[[Page 63219]]

documentation provided by the manufacturers. 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, in the January 27, 2012 technical amendment to SFAR 
106, while updating manufacturer's names due to business changes, the 
FAA inadvertently removed the previous manufacturer's names from the 
list of approved POCs. Even though these POCs are manufactured under 
new manufacturer's names, people still have POCs marked with the 
previous manufacturer's names. In this final rule, the FAA will add 
those previous manufacturer's names (International Biophysics 
Corporation's LifeChoice and Delphi Medical Systems' RS-00400) back to 
the list of approved POCs in SFAR 106.

Waiver of Notice of Proposed Rulemaking and Delay in Effective Date

    Section 553 of the Administrative Procedure Act, 5 U.S.C 
553(b)(3)(B), provides that, when an agency for good cause finds that 
notice and public procedure are impracticable, unnecessary, or contrary 
to the public interest, the agency may issue a rule without providing 
notice and an opportunity for public comment. We have determined that 
there is good cause for making the rule final without prior proposal 
and opportunity for comment because the issues related to the use of 
POC devices on board aircraft have already been discussed as part of an 
earlier rulemaking. More specifically, on July 14, 2004, the FAA issued 
a notice of proposed rulemaking on the use of portable oxygen 
concentrator devices on board aircraft (69 FR 42324). Then, on July 12, 
2005, after reviewing public comments received, the FAA published 
Special Federal Aviation Regulation 106 (SFAR 106) entitled, ``Use of 
Certain Portable Oxygen Concentrator Devices on Board Aircraft.'' (70 
FR 40156) Therefore, it is unnecessary and contrary to the public 
interest to publish a notice requesting comments on this amendment.
    Moreover, pursuant to 5 U.S.C.553(d)(3), we find that good cause 
exists for making this rule effective in less than 30 days. This rule 
is being made effective 15 calendar days after its publication in the 
Federal Register to prevent unnecessary delay in acceptance of these 
devices as authorized for use on board aircraft by airlines while still 
providing airlines adequate notice and time to ensure the devices can 
be used safely on board aircraft. We believe, based on information the 
Department has received from airlines, that fifteen calendar days is 
sufficient amount of time for an airline to ensure/confirm that an FAA-
approved POC does not cause interference with avionics system on that 
carrier's aircraft and convey this information to the appropriate 
airline personnel in order to accept these devices on board aircraft 
for use by passengers who need oxygen therapy for air travel. As such, 
the FAA believes that good cause exists for making this rule effective 
15 calendar days after its publication in the Federal Register.

Regulatory Notices and Analyses

Regulatory Evaluation

    Changes to Federal regulations must undergo several economic 
analyses. First, Executive Order 12866 and Executive Order 13563 
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 additional 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 many 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 the number of 
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

[[Page 63220]]

factual basis for this determination, and the reasoning should be 
clear.
    This final rule adds additional POC devices to the list of 
authorized POC devices in SFAR 106. This 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.

Unfunded Mandates Assessment

    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.

Paperwork Reduction

    The Paperwork Reduction Act of 1995 (44 U.S.C. 3507(d)) requires 
that the FAA consider the impact of paperwork and other information 
collection burdens imposed on the public. According to the 1995 
amendments to the Paperwork Reduction Act (5 CFR 1320.8(b)(2)(vi)), an 
agency may not collect or sponsor the collection of information, nor 
may it impose an information collection requirement unless it displays 
a currently valid Office of Management and Budget (OMB) control number.
    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.

International Trade Impact Assessment

    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 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 is not 
considered an unnecessary obstacle to the foreign commerce of the 
United States, so long as the standard has a legitimate domestic 
objective, such the protection of safety, and does 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 has 
assessed the potential effect of this final] rule and determined that 
it will have only a domestic impact and therefore will not create 
unnecessary obstacles to the foreign commerce of the United States.

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.

Executive Order Determinations

Executive Order 13132, Federalism

    The FAA has analyzed this immediately adopted final rule under the 
principles and criteria of Executive Order 13132, Federalism. The 
agency determined that this action will 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, and, 
therefore, does not have Federalism implications.

Executive Order 13211, Regulations That Significantly Affect Energy 
Supply, Distribution, or Use

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

How To Obtain Additional Information

Rulemaking Documents

    An electronic copy of a rulemaking document my be obtained by using 
the Internet--
    1. Search the Federal eRulemaking Portal (https://www.regulations.gov);
    2. Visit the FAA's Regulations and Policies Web page at https://www.faa.gov/regulations_policies/or
    3. Access the Government Printing Office's Web page at https://www.gpo.gov/fdsys/.
    Copies may also be obtained by sending a request (identified by 
notice, amendment, or docket number of this rulemaking) to the Federal 
Aviation Administration, Office of Rulemaking, ARM-1, 800 Independence 
Avenue SW., Washington, DC 20591, or by calling (202) 267-9680.

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. A small entity with questions regarding this document, 
may contact its local FAA official, or the person listed under the FOR 
FURTHER INFORMATION CONTACT heading at the beginning of the preamble. 
To find out more about SBREFA on the Internet, visit https://

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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

    In consideration of the foregoing, the Federal Aviation 
Administration amends SFAR No. 106 to Chapter I 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, AirSep Focus, AirSep FreeStyle 5, Delphi 
RS-00400, DeVilbiss Healthcare iGo, Inogen One, Inogen One G2, Inogen 
One G3, Inova Labs LifeChoice, Inova Labs LifeChoice Activox, 
International Biophysics LifeChoice, Invacare XPO2, Invacare Solo2, 
Oxlife Independence Oxygen Concentrator, Oxus RS-00400, Precision 
Medical EasyPulse, Respironics EverGo, Respironics SimplyGo, SeQual 
Eclipse and SeQual SAROS 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, AirSep Focus, AirSep FreeStyle 5, Delphi RS-00400, 
DeVilbiss Healthcare iGo, Inogen One, Inogen One G2, Inogen One G3, 
Inova Labs LifeChoice, Inova Labs LifeChoice Activox, International 
Biophysics LifeChoice, Invacare XPO2, Invacare Solo2, Oxlife 
Independence Oxygen Concentrator, Oxus RS-00400, Precision Medical 
EasyPulse, Respironics EverGo, Respironics SimplyGo, SeQual Eclipse and 
SeQual SAROS 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 October 2, 2012.
Michael P. Huerta,
Acting Administrator.
[FR Doc. 2012-25412 Filed 10-15-12; 8:45 am]
BILLING CODE 4910-13-P