[Federal Register Volume 75, Number 3 (Wednesday, January 6, 2010)]
[Rules and Regulations]
[Pages 739-742]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-31380]



 ========================================================================
 Rules and Regulations
                                                 Federal Register
 ________________________________________________________________________
 
 This section of the FEDERAL REGISTER contains regulatory documents 
 having general applicability and legal effect, most of which are keyed 
 to and codified in the Code of Federal Regulations, which is published 
 under 50 titles pursuant to 44 U.S.C. 1510.
 
 The Code of Federal Regulations is sold by the Superintendent of Documents. 
 Prices of new books are listed in the first FEDERAL REGISTER issue of each 
 week.
 
 ========================================================================
 

  Federal Register / Vol. 75, No. 3 / Wednesday, January 6, 2010 / 
Rules and Regulations  

[[Page 739]]



DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 121

[Docket No. FAA-2009-0767; SFAR 106]
RIN 2120-AJ55


Use of Additional Portable Oxygen Concentrator Devices on Board 
Aircraft

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

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 four 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 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 11 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 6, 2010.

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:

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. Section 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 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 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 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 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. SFAR 106 was amended again on January 15, 2009, (74 FR 
2351) in a similar manner to add two more POC devices, Delphi Medical 
Systems' RS-00400 and Invacare Corporation's XPO2, to the original 
SFAR. This final rule adds four additional POC devices, DeVilbiss 
Healthcare Inc.'s iGo, International Biophysics Corporation's 
LifeChoice, Inogen Inc.'s Inogen One G2, and Oxlife LLC.'s Oxlife 
Independence Oxygen Concentrator, that may be carried on and used by a 
passenger on board an aircraft.
    Aircraft operators can now offer medical oxygen service as they did 
before SFAR 106 was enacted, or they can meet certain conditions and 
allow passengers to carry on and use one of the POC devices covered in 
SFAR 106. SFAR 106 is an enabling rule, which means that no aircraft 
operator is required to allow passengers to operate these POC devices 
on board its aircraft, but it may allow them to be operated on board. 
If one of these devices is allowed by the aircraft operator to be 
carried on board, the conditions in the SFAR must be met.
    When SFAR 106 was published, the FAA committed to establishing a 
single standard for all POCs so that 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 quickest and 
easiest way to serve both the passenger and the aircraft operator was 
to allow the use of the

[[Page 740]]

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 POCs. 
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 POCs, and several have requested that their 
product also be included as an acceptable device in SFAR 106. These 
manufacturers include DeVilbiss Healthcare Inc., International 
Biophysics Corporation, Inogen Inc., and Oxlife LLC. 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 http://www.regulations.gov under the following docket 
numbers:
    1. DeVilbiss Healthcare Inc.--FAA-2008-0963;
    2. International Biophysics Corporation--FAA-2009-0087;
    3. Inogen Inc.--FAA-2009-0620; and
    4. Oxlife LLC--FAA-2009-0065.
    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. DeVilbiss Healthcare Inc.'s iGo;
    2. International Biophysics Corporation's LifeChoice;
    3. Inogen Inc.'s Inogen One G2; and
    4. Oxlife LLC.'s Oxlife Independence Oxygen Concentrator.

The Rule

    This amendment to SFAR 106 will include the DeVilbiss Healthcare 
Inc.'s iGo, International Biophysics Corporation's LifeChoice, Inogen 
Inc.'s Inogen One G2, and Oxlife LLC.'s Oxlife Independence Oxygen 
Concentrator 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 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 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 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 DeVilbiss Healthcare 
Inc.'s iGo, International Biophysics Corporation's LifeChoice, Inogen 
Inc.'s Inogen One G2, and Oxlife LLC.'s Oxlife Independence Oxygen 
Concentrator 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 four 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 Evaluation, Regulatory Flexibility Determination, 
International Trade Impact Assessment, and Unfunded Mandates Assessment

    Changes to Federal regulations must undergo several economic 
analyses. First, Executive Order 12866 directs that each Federal agency 
shall propose or adopt a regulation only upon a reasoned determination 
that the benefits of the intended regulation justify its costs. Second, 
the Regulatory Flexibility Act of 1980 (Pub. L. 96-354) requires 
agencies to analyze the economic impact of regulatory changes on small 
entities. Third, the Trade Agreements Act (Pub. L. 96-39) prohibits 
agencies from setting standards that create unnecessary obstacles to 
the foreign commerce of the United States. In

[[Page 741]]

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 Special Federal Aviation Regulation 106 (SFAR 
106), Use of Certain Portable Oxygen Concentrator Devices On Board 
Aircraft, to allow for the use of the DeVilbiss Healthcare Inc.'s iGo, 
International Biophysics Corporation's LifeChoice, Inogen Inc.'s Inogen 
One G2, and Oxlife LLC.'s Oxlife Independence Oxygen Concentrator 
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 eleven 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.
    FAA has, therefore, determined that this final rule is not a 
``significant regulatory action'' as defined in section 3(f) of 
Executive Order 12866, and is not ``significant'' as defined in DOT's 
Regulatory Policies and Procedures.

Regulatory Flexibility Determination

    The Regulatory Flexibility Act of 1980 (Pub. L. 96-354) (RFA) 
establishes ``as a principle of regulatory issuance that agencies shall 
endeavor, consistent with the objectives of the rule and of applicable 
statutes, to fit regulatory and informational requirements to the scale 
of the businesses, organizations, and governmental jurisdictions 
subject to regulation. To achieve this principle, agencies are required 
to solicit and consider flexible regulatory proposals and to explain 
the rationale for their actions to assure that such proposals are given 
serious consideration.'' The RFA covers a wide-range of small entities, 
including small businesses, not-for-profit organizations, and small 
governmental jurisdictions.
    Agencies must perform a review to determine whether a rule will 
have a significant economic impact on a substantial number of small 
entities. If the agency determines that it will, the agency must 
prepare a regulatory flexibility analysis as described in the RFA.
    However, if an agency determines that a rule is not expected to 
have a significant economic impact on a substantial number of small 
entities, section 605(b) of the RFA provides that the head of the 
agency may so certify and a regulatory flexibility analysis is not 
required. The certification must include a statement providing the 
factual basis for this determination, and the reasoning should be 
clear.
    This final rule adds DeVilbiss Healthcare Inc.'s iGo, International 
Biophysics Corporation's LifeChoice, Inogen Inc.'s Inogen One G2, and 
Oxlife LLC.'s Oxlife Independence Oxygen Concentrator to the list of 
authorized POC devices in SFAR 106. Its economic impact is minimal. 
Therefore, as the FAA Administrator, I certify that this action will 
not have a significant economic impact on a substantial number of small 
entities.

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 it does not exclude 
imports that meet this objective. As a result, this final rule is not 
considered as creating an unnecessary obstacle to foreign commerce.

Unfunded Mandates Reform Act

    Title II of the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-
4) requires each Federal agency to prepare a written statement 
assessing the effects of any Federal mandate in a proposed or final 
agency rule that may result in an expenditure of $100 million or more 
(in 1995 dollars) in any one year by State, local, and Tribal 
governments, in the aggregate, or by the private sector; such a mandate 
is deemed to be a ``significant regulatory action.'' The FAA currently 
uses an inflation-adjusted value of $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 Act do not apply.

Executive Order 13132, Federalism

    The FAA has analyzed this final rule under the principles and 
criteria of Executive Order 13132, Federalism. 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

[[Page 742]]

rulemaking action qualifies for the categorical exclusion identified in 
paragraph 312f and involves no extraordinary circumstances.

Regulations That Significantly Affect Energy Supply, Distribution, or 
Use

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

Availability of Rulemaking Documents

    You can get an electronic copy using the Internet by:
    (1) Searching the Federal eRulemaking Portal at http://www.regulations.gov;
    (2) Visiting the FAA's Regulations and Policies Web page at http://www.faa.gov/regulations_policies/; or
    (3) Accessing the Government Printing Office's Web page at http://www.gpoaccess.gov/fr/index.html.
    You can also get a copy by sending a request to the Federal 
Aviation Administration, Office of Rulemaking, ARM-1, 800 Independence 
Avenue, SW., Washington, DC 20591, or by calling (202) 267-9680. Make 
sure to identify the amendment number or docket number of this 
rulemaking.

Small Business Regulatory Enforcement Fairness Act

    The Small Business Regulatory Enforcement Fairness Act (SBREFA) of 
1996 requires FAA to comply with small entity requests for information 
or advice about compliance with statutes and regulations within its 
jurisdiction. Therefore, any small entity that has a question regarding 
this document may contact their local FAA official, or the person 
listed under FOR FURTHER INFORMATION CONTACT. You can find out more 
about SBREFA on the Internet at our site, http://www.faa.gov/regulations_policies/rulemaking/sbre_act/.

List of Subjects in 14 CFR Part 121

    Air carriers, Aircraft, Airmen, Alcohol abuse, Drug abuse, 
Reporting and recordkeeping requirements.

The Amendment

0
In consideration of the foregoing, the Federal Aviation Administration 
amends SFAR No. 106 to Chapter II of Title 14, Code of Federal 
Regulations, as follows:

PART 121--OPERATING REQUIREMENTS: DOMESTIC, FLAG, AND SUPPLEMENTAL 
OPERATIONS

0
1. The authority citation for part 121 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 1153, 40101, 40102, 40103, 40113, 
41721, 44105, 44106, 44111, 44701-44717, 44722, 44901, 44903, 44904, 
44906, 44912, 44914, 44936, 44938, 46103, 46105.


0
2. Amend SFAR 106 by revising sections 2 and 3(a) introductory text to 
read as follows:

Special Federal Aviation Regulation 106--Rules for Use of Portable 
Oxygen Concentrator Systems on Board Aircraft

* * * * *
    Section 2. Definitions--For the purposes of this SFAR the following 
definitions apply: Portable Oxygen Concentrator: means the AirSep 
FreeStyle, AirSep LifeStyle, Delphi RS-00400, DeVilbiss Healthcare iGo, 
Inogen One, Inogen One G2, International Biophysics LifeChoice, 
Invacare XPO100, Oxlife Independence Oxygen Concentrator, Respironics 
EverGo, and SeQual Eclipse Portable Oxygen Concentrator medical device 
units as long as those medical device units: (1) Do not contain 
hazardous materials as determined by the Pipeline and Hazardous 
Materials Safety Administration; (2) are also regulated by the Food and 
Drug Administration; and (3) assist a user of medical oxygen under a 
doctor's care. These units perform by separating oxygen from nitrogen 
and other gases contained in ambient air and dispensing it in 
concentrated form to the user.
    Section 3. Operating Requirements--
    (a) No person may use and no aircraft operator may allow the use of 
any portable oxygen concentrator device, except the AirSep FreeStyle, 
AirSep LifeStyle, Delphi RS-00400, DeVilbiss Healthcare iGo, Inogen 
One, Inogen One G2, International Biophysics LifeChoice, Invacare 
XPO100, Oxlife Independence Oxygen Concentrator, Respironics EverGo, 
and SeQual Eclipse Portable Oxygen Concentrator units. These units may 
be carried on and used by a passenger on board an aircraft provided the 
aircraft operator ensures that the following conditions are satisfied:
* * * * *

    Issued in Washington, DC, on December 22, 2009.
J. Randolph Babbitt,
Administrator.
[FR Doc. E9-31380 Filed 1-5-10; 8:45 am]
BILLING CODE 4910-13-P