[Federal Register Volume 77, Number 200 (Tuesday, October 16, 2012)]
[Rules and Regulations]
[Pages 63217-63221]
From the Federal Register Online via the Government Publishing 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 [email protected].
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 (http://www.regulations.gov);
2. Visit the FAA's Regulations and Policies Web page at http://www.faa.gov/regulations_policies/or
3. Access the Government Printing Office's Web page at http://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 http://
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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]
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