[Federal Register: January 15, 2009 (Volume 74, Number 10)]
[Rules and Regulations]
[Page 2351-2355]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr15ja09-8]
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DEPARTMENT OF TRANSPORTATION
Federal Aviation Administration
14 CFR Part 121
[Docket No. FAA-2008-1227; SFAR 106]
RIN 2120-AJ40
Use of Additional Portable Oxygen Concentrator Devices On Board
Aircraft
AGENCY: Federal Aviation Administration (FAA), DOT.
ACTION: Final rule.
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SUMMARY: This action amends Special Federal Aviation Regulation 106
(SFAR 106), Use of Certain Portable Oxygen Concentrator Devices On
Board Aircraft, to allow for the use of the Delphi Medical Systems' RS-
00400 and Invacare Corporation's XPO2 portable oxygen concentrator
(POC) devices on board aircraft, provided certain conditions in the
SFAR are met. SFAR 106 was previously amended to add three additional
POC devices to the original SFAR. Today's action is necessary to allow
all POC devices deemed acceptable by the FAA to be available for use in
air commerce to the traveling public in need of oxygen therapy. With
this Final Rule, there will be a total of seven different POC devices
the FAA finds acceptable for use on board aircraft, and passengers will
be able to carry these devices on board the aircraft and use them with
the approval of the aircraft operator.
DATES: This final rule amending SFAR 106 will become effective on
January 15, 2009.
FOR FURTHER INFORMATION CONTACT: David Catey, Air Transportation
Division, Flight Standards Service, Federal Aviation Administration,
800 Independence Avenue, SW., Washington, DC 20591. Telephone: (202)
267-8166.
SUPPLEMENTARY INFORMATION:
Availability of Rulemaking Documents
You can get an electronic copy using the Internet by:
(1) Searching the Federal eRulemaking Portal at 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
[[Page 2352]]
more about SBREFA on the Internet at our site, http://www.faa.gov/
regulations_policies/rulemaking/sbre_act/.
Authority for This Rulemaking
The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code (49 U.S.C.). Subtitle I,
Section 106 describes the authority of the FAA Administrator. Subtitle
VII, Aviation Programs, describes in more detail the scope of the
agency's authority.
The FAA is authorized to issue this final rule pursuant to 49
U.S.C. 44701. Under that section, the FAA is authorized to establish
regulations and minimum standards for other practices, methods, and
procedures the Administrator finds necessary for air commerce and
national security.
Background
On July 12, 2005, the FAA published Special Federal Aviation
Regulation 106 (SFAR 106) entitled, ``Use of Certain Portable Oxygen
Concentrator Devices On Board Aircraft'' (70 FR 40156). SFAR 106 is the
result of a notice of proposed rulemaking (NPRM) the FAA published in
July 2004 (69 FR 42324) to address the needs of passengers who must
travel with medical oxygen. Prior to publication of SFAR 106,
passengers in need of medical oxygen during air transportation faced
many obstacles when requesting service. Many aircraft operators did not
provide medical oxygen service aboard flights, and those that did often
provided service at a price that travelers could not afford.
Coordinating service between operators and suppliers at airports was
also difficult, and passengers frequently chose not to fly because of
these difficulties.
New medical oxygen technologies approved by the Food and Drug
Administration (FDA) reduce the risks typically associated with
compressed oxygen and provide a safe alternative for passengers who
need oxygen therapy. Several manufacturers have developed small
portable oxygen concentrator (POC) devices that work by separating
oxygen from nitrogen and other gases contained in ambient air and
dispensing it in concentrated form to the user with an oxygen
concentration of about 90%. The POC devices operate using either
rechargeable batteries or, if the aircraft operator obtains approval
from the FAA, aircraft electrical power.
In addition, the Pipeline and Hazardous Materials Safety
Administration (PHMSA) has determined that the POC devices covered by
this amendment are not hazardous materials. Thus, they do not require
the same level of special handling as compressed oxygen, and are safe
for use on board aircraft, provided certain conditions for their use
are met.
SFAR 106 permits passengers to carry on and use certain POC devices
on board aircraft if the aircraft operator ensures that the conditions
specified in the SFAR for their use are met. The devices initially
determined acceptable for use in SFAR 106, published July 12, 2005,
were the AirSep Corporation's LifeStyle and the Inogen, Inc.'s Inogen
One POCs. SFAR 106 was amended on September 12, 2006 (71 FR 53954) to
add three additional POC devices, AirSep Corporation's FreeStyle,
SeQual Technologies' Eclipse, and Repironics Inc.'s EverGo, to the
original SFAR. This final rule adds two additional POC devices, Delphi
Medical Systems' RS-00400 and Invacare Corporation's XPO2, that may be
carried on and used by a passenger on board an aircraft.
Aircraft operators can now offer medical oxygen service as they did
before SFAR 106 was enacted, or they can meet certain conditions and
allow passengers to carry on and use one of the POC devices covered in
SFAR 106. SFAR 106 is an enabling rule, which means that no aircraft
operator is required to allow passengers to operate these POC devices
on board its aircraft, but it may allow them to be operated on board.
If the aircraft operator allows one of these devices to be carried on
board, the conditions in the SFAR must be met.
When SFAR 106 was originally published, the FAA committed to
establishing a single standard for all POC devices so that regulations
would not apply to specific manufacturers and models of devices.
Whenever possible, the FAA tries to regulate by creating performance-
based standards rather than approving specific devices by manufacturer.
In the case of SFAR 106, the quickest and easiest way to serve both the
passenger and the aircraft operator was to allow the use of the devices
determined to be acceptable by the FAA in SFAR 106 in a special,
temporary regulation. As we stated in the preamble discussion of the
final rule that established SFAR 106, ``while we are committed to
developing a performance-based standard for all future POC devices, we
do not want to prematurely develop standards that have the effect of
stifling new technology of which we are unaware.'' We developed and
published SFAR 106 so that passengers who otherwise could not fly could
do so with an affordable alternative to what existed before SFAR 106
was published.
We continue to pursue the performance-based standard for all POC
devices. This process is time-consuming and we intend to publish a
notice in the Federal Register and offer the public a chance to comment
on the proposal when it is complete. In the meantime, manufacturers
continue to create new and better POC devices, and several have
requested that their product also be included as an acceptable device
in SFAR 106. These new manufacturers include Delphi Medical Systems and
Invacare Corporation. Each of these companies has formally petitioned
the FAA for inclusion in SFAR 106 by submitting documentation of the
devices to the Federal Docket Management System. That documentation is
available at http://www.regulations.gov under the following docket
numbers:
1. Delphi Medical Systems--FAA-2008-0261; and
2. Invacare Corporation--FAA-2008-0278.
As stated in Section 2 of SFAR 106, no covered device may contain
hazardous materials as determined by PHMSA (written documentation
necessary), and each device must also be regulated by the FDA. Each
petitioner included technical specifications for the devices in their
request for approval, along with the required documentation from PHMSA
and the FDA. The petitioners provided the FAA with the required
documentation for the following POC devices:
1. Delphi Medical Systems', Model RS-00400; and
2. Invacare Corporation's, Model XPO2.
The Rule
This amendment to SFAR 106 will include the Delphi Medical Systems'
RS-00400 and Invacare Corporation's XPO2 devices in the list of POC
devices authorized for use in air commerce. The FAA has reviewed each
individual device and accepted the documentation provided by the two
manufacturers. That documentation includes letters provided to the
manufacturer by PHMSA and the FDA affirming the status of each device
as it pertains to the requisites stated in SFAR 106.
After reviewing the applicable FDA safety standards and the PHMSA
findings, these two devices were determined by the FAA to be acceptable
for use in air commerce.
Good Cause for Adoption of This Final Rule Without Notice and Comment
As stated above, SFAR 106 was published on July 12, 2005. We stated
in the preamble of that final rule that
[[Page 2353]]
the AirSep LifeStyle and Inogen One POC devices were the only known
acceptable devices when the rule was published. We also stated in that
final rule that ``we cannot predict how future products may be
developed and work.'' We initiated a notice and comment period for the
use of POC devices on board aircraft on July 14, 2004 (69 FR 42324) and
responded to the comments received in response to that NPRM in the
final rule published in 2005. Therefore, it is unnecessary to publish a
notice to request comments on this amendment because all issues related
to the use of POC devices on board an aircraft have already been
discussed. Further notice and comment would also delay the acceptance
of the Delphi Medical Systems' RS-00400 and Invacare Corporation's XPO2
POC devices as authorized for use on board aircraft, which would delay
their availability for passengers in need of oxygen therapy.
Therefore, I find that notice and public comment under 5 U.S.C.
553(b) is unnecessary and contrary to the public interest. Further, I
find that good cause exists for making this rule effective immediately
upon publication.
International Compatibility
In keeping with U.S. obligations under the Convention on
International Civil Aviation, it is FAA policy to comply with
International Civil Aviation Organization (ICAO) Standards and
Recommended Practices to the maximum extent practicable. The FAA
determined that there are no ICAO Standards and Recommended Practices
that correspond to these regulations. I find that this action is fully
consistent with my obligations under 49 U.S.C. 40105(b)(1)(A) to ensure
that I exercise my duties consistently with the obligations of the
United States under international agreements.
Paperwork Reduction Act
As required by the Paperwork Reduction Act of 1995 (44 U.S.C.
3507(d)), the FAA submitted a copy of the new information collection
requirements in SFAR 106 to the Office of Management and Budget for its
review. OMB approved the collection of this information and assigned
OMB Control Number 2120-0702.
This final rule requires that if a passenger carries a POC device
on board the aircraft with the intent to use it during the flight, he
or she must inform the pilot in command of that flight. Additionally,
the passenger who plans to use the device must provide a written
statement signed by a licensed physician that verifies the passenger's
ability to operate the device, respond to any alarms, the extent to
which the passenger must use the POC (all or a portion of the flight),
and prescribes the maximum oxygen flow rate.
Please note that an agency may not conduct or sponsor, and a person
is not required to respond to, a collection of information unless it
displays a currently valid OMB control number. The Paperwork Reduction
Act paragraph in the final rule that established SFAR 106 still applies
to this amendment. The availability of two new POC devices will likely
increase the availability and options for a passenger in need of oxygen
therapy, but the paperwork burden discussed in the original final rule
is unchanged. Therefore, the OMB Control Number associated with this
collection remains 2120-0702.
Regulatory Analyses
Executive Order 12866 and DOT Regulatory Policies and Procedures
Changes to Federal regulations must undergo several economic
analyses. First, Executive Order 12866 directs that each Federal agency
shall propose or adopt a regulation only upon a reasoned determination
that the benefits of the intended regulation justify its costs. Second,
the Regulatory Flexibility Act of 1980 (Pub. L. 96-354) requires
agencies to analyze the economic impact of regulatory changes on small
entities. Third, the Trade Agreements Act (Pub. L. 96-39) prohibits
agencies from setting standards that create unnecessary obstacles to
the foreign commerce of the United States. In developing U.S.
standards, the Trade Agreements Act requires agencies to consider
international standards and, where appropriate, that they be the basis
of U.S. standards. Fourth, the Unfunded Mandates Reform Act of 1995
(Pub. L. 104-4) requires agencies to prepare a written assessment of
the costs, benefits, and other effects of proposed or final rules that
include a Federal mandate likely to result in the expenditure by State,
local, or tribal governments, in the aggregate, or by the private
sector, of $100 million or more annually (adjusted for inflation with
base year of 1995). This portion of the preamble summarizes the FAA's
analysis of the economic impacts of this final rule.
Department of Transportation Order DOT 2100.5 prescribes policies
and procedures for simplification, analysis, and review of regulations.
If the expected cost impact is so minimal that a proposed or final rule
does not warrant a full evaluation, this order permits that a statement
to that effect and the basis for it to be included in the preamble if a
full regulatory evaluation of the cost and benefits is not prepared.
Such a determination has been made for this final rule. The reasoning
for this determination follows:
This action amends Special Federal Aviation Regulation 106 (SFAR
106), Use of Certain Portable Oxygen Concentrator Devices On Board
Aircraft, to allow for the use of the Delphi Medical Systems' RS-00400
and Invacare Corporation's XPO2 portable oxygen concentrator (POC)
devices on board aircraft, provided certain conditions in the SFAR are
met. This action is necessary to allow additional POC devices deemed
acceptable by the FAA to be available to the traveling public in need
of oxygen therapy, for use in air commerce. When this rule becomes
effective, there will be a total of seven different POC devices the FAA
finds acceptable for use on board aircraft, and passengers will be able
to carry these devices on board the aircraft and use them with the
approval of the aircraft operator.
The FAA has determined that this final rule is not a ``significant
regulatory action'' as defined in section 3(f) of Executive Order
12866, and is not ``significant'' as defined in DOT's Regulatory
Policies and Procedures.
Regulatory Flexibility Determination
The Regulatory Flexibility Act of 1980 (Pub. L. 96-354) (RFA)
establishes ``as a principle of regulatory issuance that agencies shall
endeavor, consistent with the objectives of the rule and of applicable
statutes, to fit regulatory and informational requirements to the scale
of the businesses, organizations, and governmental jurisdictions
subject to regulation. To achieve this principle, agencies are required
to solicit and consider flexible regulatory proposals and to explain
the rationale for their actions to assure that such proposals are given
serious consideration.'' The RFA covers a wide-range of small entities,
including small businesses, not-for-profit organizations, and small
governmental jurisdictions.
Agencies must perform a review to determine whether a rule will
have a significant economic impact on a substantial number of small
entities. If the agency determines that it will, the agency must
prepare a regulatory flexibility analysis as described in the RFA.
However, if an agency determines that a rule is not expected to
have a significant economic impact on a substantial number of small
entities, section 605(b) of the RFA provides that the head of the
agency may so certify
[[Page 2354]]
and a regulatory flexibility analysis is not required. The
certification must include a statement providing the factual basis for
this determination, and the reasoning should be clear.
This final rule adds Delphi Medical Systems' RS-00400 and Invacare
Corporation's XPO2 to the list of authorized POC devices in SFAR 106.
Its economic impact is minimal. Therefore, as the Acting FAA
Administrator, I certify that this action will not have a significant
economic impact on a substantial number of small entities.
International Trade Analysis
The Trade Agreements Act of 1979 (Pub. L. 96-39), as amended by the
Uruguay Round Agreements Act (Pub. L. 103-465), prohibits Federal
agencies from establishing any standards or engaging in related
activities that create unnecessary obstacles to the foreign commerce of
the United States. Pursuant to these Acts, the establishment of
standards are not considered unnecessary obstacles to the foreign
commerce of the United States, so long as the standards have a
legitimate domestic objective, such the protection of safety, and do
not operate in a manner that excludes imports that meet this objective.
The statute also requires consideration of international standards and,
where appropriate, that they be the basis for U.S. standards. The FAA
notes the purpose is to ensure the safety of the American public, and
has assessed the effects of this rule to ensure that it does not
exclude imports that meet this objective. As a result, this rule is not
considered as creating an unnecessary obstacle to foreign commerce.
In accordance with the above statute and policy, the FAA has
assessed the potential effect of this final rule and has determined
that it will impose the same minimal impact on domestic and
international entities and thus has a neutral trade impact.
Unfunded Mandates Reform Act
The Unfunded Mandates Reform Act of 1995 (the Act), enacted as
Public Law 104-4 on March 22, 1995, is intended, among other things, to
curb the practice of imposing unfunded Federal mandates on State,
local, and tribal governments. Title II of the Act requires each
Federal agency to prepare a written statement assessing the effects of
any Federal mandate in a proposed or final agency rule that may result
in a $100 million or more expenditure (adjusted annually for inflation)
in any one year by State, local, and tribal governments, in the
aggregate, or by the private sector; such a mandate is deemed to be a
``significant regulatory action.'' The FAA currently uses an inflation-
adjusted value of $136.1 million in lieu of $100 million.
This final rule does not contain such a mandate. Therefore, the
requirements of Title II of the Unfunded Mandates Reform Act of 1995 do
not apply.
Executive Order 13132, Federalism
The FAA has analyzed this final rule under the principles and
criteria of Executive Order 13132, Federalism. We determined that this
action will not have a substantial direct effect on the States, or the
relationship between the national Government and the States, or on the
distribution of power and responsibilities among the various levels of
government. Therefore, we have determined that this final rule does not
have federalism implications.
Plain Language
In response to the June 1, 1998 Presidential Memorandum regarding
the use of plain language, the FAA re-examined the writing style
currently used in the development of regulations. The memorandum
requires federal agencies to communicate clearly with the public. We
are interested in your comments on whether the style of this document
is clear, and in any other suggestions you might have to improve the
clarity of FAA communications that affect you. You can get more
information about the Presidential memorandum and the plain language
initiative at http//:www.plainlanguage.gov.
Environmental Analysis
FAA Order 1050.1E identifies FAA actions that are categorically
excluded from preparation of an environmental assessment or
environmental impact statement under the National Environmental Policy
Act in the absence of extraordinary circumstances. The FAA has
determined this rulemaking action qualifies for the categorical
exclusion identified in paragraph 312f and involves no extraordinary
circumstances.
Regulations That Significantly Affect Energy Supply, Distribution, or
Use
The FAA has analyzed this final rule under Executive Order 13211,
Actions Concerning Regulations that Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355; May 18, 2001). We have determined
that it is not a ``significant energy action'' under the executive
order because it is not a ``significant regulatory action'' under
Executive Order 12866, and it is not likely to have a significant
adverse effect on the supply, distribution, or use of energy.
The Amendment
In consideration of the foregoing, the Federal Aviation
Administration amends SFAR No. 106 to Chapter II of Title 14, Code of
Federal Regulations, as follows:
PART 121--OPERATING REQUIREMENTS: DOMESTIC, FLAG, AND SUPPLEMENTAL
OPERATIONS
0
1. The authority citation for part 121 continues to read as follows:
Authority: 49 U.S.C. 106(g), 1153, 40101, 40102, 40103, 40113,
41721, 44105, 44106, 44111, 44701-44717, 44722, 44901, 44903, 44904,
44906, 44912, 44914, 44936, 44938, 46103, 46105.
0
2. Amend SFAR 106 by revising sections 2 and 3(a) introductory text to
read as follows:
Special Federal Aviation Regulation 106--Rules for Use of Portable
Oxygen Concentrator Systems On Board Aircraft
* * * * *
Section 2. Definitions--For the purposes of this SFAR the following
definitions apply: Portable Oxygen Concentrator: means the AirSep
FreeStyle, AirSep LifeStyle, Delphi RS-00400, Inogen One, Invacare
XPO2, Respironics EverGo, and SeQual Eclipse Portable Oxygen
Concentrator medical devices as long as those medical devices: (1) Do
not contain hazardous materials as determined by the Pipeline and
Hazardous Materials Safety Administration; (2) are also regulated by
the Food and Drug Administration; and (3) assist a user of medical
oxygen under a doctor's care. These units perform by separating oxygen
from nitrogen and other gases contained in ambient air and dispensing
it in concentrated form to the user.
Section 3. Operating Requirements--
(a) No person may use and no aircraft operator may allow the use of
any portable oxygen concentrator device, except the AirSep FreeStyle,
AirSep LifeStyle, Delphi RS-00400, Inogen One, Invacare XPO2,
Respironics EverGo, or SeQual Eclipse Portable Oxygen Concentrator
devices. These devices may be carried on and used by a passenger on
board an aircraft provided the aircraft operator ensures that the
following conditions are satisfied:
* * * * *
[[Page 2355]]
Issued in Washington, DC on January 7, 2009.
Robert Sturgell,
Acting Administrator.
[FR Doc. E9-790 Filed 1-14-09; 8:45 am]
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