Use of Additional Portable Oxygen Concentrators on Board Aircraft, 6078-6082 [2014-02121]

Agencies

• Federal Aviation Administration
• DEPARTMENT OF TRANSPORTATION

[Federal Register Volume 79, Number 22 (Monday, February 3, 2014)]
[Rules and Regulations]
[Pages 6078-6082]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-02121]


-----------------------------------------------------------------------

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 121

[Docket No.: FAA-2013-1013; Amdt. No. 121-367]
RIN 2120-AK-35


Use of Additional Portable Oxygen Concentrators on Board Aircraft

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Immediately adopted final rule.

-----------------------------------------------------------------------

SUMMARY: This action amends the FAA's rules for permitting use of 
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 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 February 18, 2014.

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

[[Page 6079]]

Independence Avenue SW., Washington, DC 20591; telephone 202-267-8166; 
email DK.Deaderick@faa.gov. For legal questions concerning this action, 
contact Robert H. Frenzel, Manager, Operations Law Branch, Office of 
the Chief Counsel, Regulations Division (AGC-220), Federal Aviation 
Administration, 800 Independence Avenue SW., Washington, DC 20591; 
telephone 202-267-3073; email Robert.Frenzel@faa.gov.

SUPPLEMENTARY INFORMATION:

Good Cause for Immediate Adoption

    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 (NPRM) on the use of POC 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, the 
FAA has determined that notice and public comment are unnecessary.
    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 of additional POC devices 
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 that an FAA-approved POC device does 
not cause interference with avionics systems 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 medical 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.

Authority for This Rulemaking

    The FAA's authority to issue rules on aviation safety is found in 
Title 49 of the United States Code (U.S.C.). This rulemaking is 
promulgated under the authority described in 49 U.S.C. 106(f), which 
vests final authority in the Administrator for carrying out all 
functions, powers, and duties of the administration relating to the 
promulgation of regulations and rules, and section 44701(a)(5), which 
requires the Administrator to promulgate regulations and minimum 
standards for other practices, methods, and procedures necessary for 
safety in air commerce and national security.

I. Overview of the Immediately Adopted Final Rule

    This action amends SFAR 106 and permits the use of additional POC 
devices on board aircraft. Specifically, the FAA is adding the use of 
SeQual Technologies's eQuinox (model 4000) and Oxywell (Model 4000), 
and VBOX Inc.'s Trooper on the list of POC devices authorized for use 
in air commerce. The FAA has reviewed these devices and accepted the 
documentation provided by the manufacturer. After reviewing the 
applicable Food and Drug Administration (FDA) safety standards and the 
Pipeline and Hazardous Materials Safety Administration (PHMSA) 
findings, the devices were determined by the FAA to be acceptable for 
use in air commerce.

II. Background

A. Statement of the Problem

    When SFAR 106 was published, the FAA committed to establishing a 
single performance standard for all POCs so the regulations would not 
apply to specific manufacturers and models of device. Whenever 
possible, the FAA tries to regulate by creating performance-based 
standards. 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 POCs, 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 
POC devices. 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 innovative POC devices, and 
manufacturers have requested that their products also be included as 
acceptable POC devices in SFAR 106. SeQual Technologies, Inc. and VBOX, 
Inc. have submitted requests for approval and addition to SFAR 106, 
with all required documentation for their POC devices, to the FAA.

B. Related Actions

    On July 12, 2005, the FAA published 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 on July 
14, 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.
    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 106 for their use are met. The POC devices 
initially determined acceptable for use in SFAR 106, published July 14, 
2005, were AirSep Corporation's LifeStyle and Inogen, Inc.'s Inogen 
One. SFAR 106 has been amended six times to allow passengers to use 
additional devices.

III. Discussion of the Immediately Adopted Rule

    New medical oxygen technologies (POC devices) approved by the 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 POC devices that work by 
separating

[[Page 6080]]

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. 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.
    This immediately adopted amendment to SFAR 106 is adding three 
additional POC devices, thus, increasing the number of options for 
aircraft passengers to carry on and use on board aircraft. The FAA is 
adding SeQual Technologies, Inc.'s eQuinox Oxygen System (model 4000) 
and Oxywell Oxygen System (model 4000), as well as VBOX, Inc.'s Trooper 
device to the list of POC devices that may be carried on and used by a 
passenger on board an aircraft. Each manufacturer has included 
technical specifications for their devices in each request for 
approval, as well as the required documentation from PHMSA and the FDA.
    SFAR 106 is an enabling rule, which means that no aircraft operator 
is required to allow passengers to operate POC devices on board. If an 
aircraft operator chooses to allow a passenger to operate these 
devices, SFAR 106 enables such action, provided that the SFAR 106 
conditions are met.

IV. Regulatory Notices and Analyses

A. Regulatory Evaluation

    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 of 1979 (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. 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.

B. 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.
    As this final rule enables additional POC devices to be carried on 
board aircraft, the rule provides benefits at minimal costs for 
passengers and minimal implementation costs for all business entities.
    Therefore, as provided in section 605(b), the head of the FAA 
certifies that this rulemaking will not result in a significant 
economic impact on a substantial number of small entities.

C. 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 immediately adopted 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.

D. 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

[[Page 6081]]

$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.

E. 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.

F. International Compatibility and Cooperation

    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.
    Executive Order 13609, Promoting International Regulatory 
Cooperation, promotes international regulatory cooperation to meet 
shared challenges involving health, safety, labor, security, 
environmental, and other issues and to reduce, eliminate or prevent 
unnecessary differences in regulatory requirements. The FAA has 
analyzed this action under the policies and agency responsibilities of 
Executive Order 13609, and has determined that this action would have 
no effect on international regulatory cooperation.

G. 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.

V. Executive Order Determinations

A. 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.

B. 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.

VI. How To Obtain Additional Information

A. Rulemaking Documents

    An electronic copy of a rulemaking document may 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.

B. 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://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(f), 106(g), 40113, 40119, 41706, 
44101, 44701-44702, 44705, 44709-44711, 44713, 44716-44717, 44722, 
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

[[Page 6082]]

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, SeQual eQuinox Oxygen System (model 4000), 
SeQual Oxywell Oxygen System (model 4000), SeQual SAROS and VBOX 
Trooper 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, 
SeQual eQuinox Oxygen System (model 4000), SeQual Oxywell Oxygen System 
(model 4000), SeQual SAROS and VBOX Trooper 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 under authority provided by 49 U.S.C. 106(f) and 
44701(a)(5) in Washington, DC, on December 23, 2013.
Michael P. Huerta,
Administrator.
[FR Doc. 2014-02121 Filed 1-31-14; 8:45 am]
BILLING CODE 4910-13-P