[Federal Register Volume 70, Number 132 (Tuesday, July 12, 2005)]
[Rules and Regulations]
[Pages 40156-40164]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-13664]



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Part III





Department of Transportation





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Federal Aviation Administration



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14 CFR Parts 11 and 121



Use of Certain Portable Oxygen Concentrator Devices Onboard Aircraft; 
Final Rule

  Federal Register / Vol. 70, No. 132 / Tuesday, July 12, 2005 / Rules 
and Regulations  

[[Page 40156]]


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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Parts 11 and 121

[Docket No.: FAA-2004-18596; SFAR No. 106]
RIN 2120-AI30


Use of Certain Portable Oxygen Concentrator Devices Onboard 
Aircraft

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: This Special Federal Aviation Regulation (SFAR) will permit 
passengers to use certain portable oxygen concentrator (POC) devices on 
aircraft, provided certain conditions in this SFAR are satisfied. The 
SFAR includes a POC preparation requirement for carry-on baggage 
transport, and a battery-packaging standard necessary for the safe 
carriage of extra POC batteries in carry-on baggage. This rulemaking 
action is necessary to address the travelling needs of people on oxygen 
therapy.

DATES: This SFAR becomes effective August 11, 2005.

FOR FURTHER INFORMATION CONTACT: David L. Catey, Air Transportation 
Division, AFS-200, Federal Aviation Administration, 800 Independence 
Avenue SW., Washington, DC 20591; telephone (202) 267-3732.

SUPPLEMENTARY INFORMATION: 

Availability of Rulemaking Documents

    You can get an electronic copy using the Internet by:
    (1) Searching the Department of Transportation's electronic Docket 
Management System (DMS) web page (http://dms.dot.gov/search);
    (2) Visiting the Office of Rulemaking's web page at http://www.faa.gov/avr/arm/index.cfm; or
    (3) Accessing the Government Printing Office's web page at http://www.access.gpo.gov/su_docs/aces/aces140.html.
    You can also get a copy by submitting 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.
    Anyone is able to search the electronic form of all comments 
received into any of our dockets by the name of the individual 
submitting the comment (or signing the comment, if submitted on behalf 
of an association, business, labor union, etc.). You may review DOT's 
complete Privacy Act statement in the Federal Register published on 
April 11, 2000 (Volume 65, Number 70; Pages 19477-78) or you may visit 
http://dms.dot.gov.

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. If you are a small entity and you have a question 
regarding this document, you may contact its local FAA official, or the 
person listed under FOR FURTHER INFORMATION CONTACT. You can find out 
more about SBREFA on the Internet at http://www.faa.gov/avr/arm/sbrefa.cfm.

Authority for This Rulemaking

    The FAA is authorized to issue this 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 procedure the 
Administrator finds necessary for air commerce and national security.''

Background

    This final rule responds to comments received on notice of proposed 
rulemaking (NPRM) titled ``Use of Portable Oxygen Concentrator Devices 
Onboard Aircraft,'' (69 FR 42324; July 14, 2004). The NPRM proposed a 
Special Federal Aviation Regulation (SFAR) to allow passengers to 
operate certain portable oxygen concentrator (POC) devices on aircraft 
if certain conditions detailed in the proposal were met.
    As stated in the NPRM, the FAA recognizes that there is a critical 
need to improve service for passengers who have a medical need to 
travel with medical oxygen. Passengers requiring medical oxygen during 
air travel have faced significant difficulties obtaining adequate air 
service. Many carriers do not provide medical oxygen during air travel. 
Those carriers that provide the service often charge for the service--
sometimes at a cost that equals the price of a ticket. Additionally, it 
can be difficult to coordinate service between the carrier and a 
supplier of medical oxygen to ensure passenger coverage both at the 
terminal and on the aircraft. Sometimes, the passenger must spend at 
least part of the time travelling without medical oxygen due to service 
problems with the oxygen provider.
    Compressed oxygen is regulated as a Hazardous Material by the 
Pipeline and Hazardous Materials Safety Administration (PHMSA), 
formerly the Research and Special Programs Administration (RSPA), under 
title 49 CFR 172.101. The FAA also regulates oxygen furnished by 
aircraft operators to passengers who have a medical need for oxygen on 
board the aircraft. Oxygen is highly regulated because, as an oxidizer, 
it can enhance an existing fire, and it can support combustion of 
certain flammable materials, whether or not an ignition source is 
present. The FAA's medical oxygen regulations, 14 CFR 121.574, 125.219, 
and 135.91, currently allow aircraft operators to furnish equipment for 
the storage, generation, or dispensing of oxygen to passengers provided 
all of the following conditions are met:
    The equipment is:
    1. Furnished by the certificate holder;
    2. Of an approved type or is in conformity with the manufacturing, 
packaging, marking, labelling and maintenance requirements of 49 CFR 
parts 171, 172 and 173 except 173.24(a)(1);
    3. Maintained by the aircraft operator in accordance with an 
approved maintenance program;
    4. Free of flammable contaminants on all exterior surfaces;
    5. Capable of providing a minimum mass flow of oxygen to the user 
of four liters per minute (this provision is not contained in either 
part 125 or 135 regulations);
    6. Constructed so that all valves, fittings and gauges are 
protected from damage; and
    7. Appropriately secured.
    Recently new medical oxygen technologies have been approved by the 
Food and Drug Administration that reduce the risks typically associated 
with compressed oxygen. Two companies--AirSep Corporation and Inogen, 
Inc.--have developed small POCs that work by filtering out nitrogen 
from the air and providing the user with oxygen at a concentration of 
about 90%. The POCs operate using either rechargeable batteries or, if 
approved by the FAA, aircraft electrical power.
    In addition, PHMSA, formerly RSPA, has determined that the POCs are 
not hazardous materials. Thus they do not require the same level of 
special handling as compressed oxygen, and are safe for use onboard 
aircraft provided certain conditions for their use are met.

Summary

    This SFAR establishes requirements applicable to passenger-supplied 
POCs used on aircraft. With the adoption of this rule, passengers will 
be able to choose between two different kinds of

[[Page 40157]]

portable oxygen concentrator (POC) devices to operate onboard an 
aircraft during travel. The NPRM published in July 2004 explained the 
proposal and this final rule adopts much of that original proposal, 
with some modifications, including:
    1. Some proposed requirements that would have been placed on air 
carriers are now the responsibility of the POC user;
    2. The Inogen One POC, mentioned only as being studied in the NPRM, 
is included as an eligible portable electronic device in the SFAR in 
response to comments;
    3. We will allow passengers using a POC to walk around the cabin 
while carrying the device. However, when a passenger has a medical need 
to use a POC during movement on the surface, takeoff, and landing, the 
person using the POC must be seated in seat location so as not to 
restrict other passenger's access to, or use of, any required 
emergency, or regular exit. Additionally, the POC user must be seated 
in a location so as not to restrict access to the aisle(s) of the 
passenger compartment. Passengers who do not have a medical need to use 
a POC during movement on the surface, takeoff and landing, and are not 
seated in accordance with the preceding requirements, must properly 
stow the POC so it does not block access to the aisleway (e.g., under 
the passenger seat in front of the user). In either case, POCs and the 
extra batteries needed to power them must be properly stowed in 
accordance with the applicable carry-on baggage requirements of 14 CFR 
91.523, 91.525, 121.285, 121.589, 125.183, and 135.87.
    4. Several extra batteries may be required to power the POCs for 
some flights and we are including a battery-packaging standard for POC 
batteries included in carry-on baggage. (Section 3(b)(6) of the SFAR)
    We don't feel that any of these modifications go outside the scope 
of the original NPRM since we specifically cited the Inogen One POC and 
sought comment on who should be responsible for certain aspects of the 
rule. All comments are addressed below.
    The SFAR is an enabling rule, which means that no aircraft operator 
is required to allow passengers to operate these devices onboard, but 
they may allow them to be operated onboard. If an aircraft operator 
chooses to allow a passenger to operate these devices onboard the 
aircraft operator's aircraft the conditions in the SFAR must be met.
    Presently, there are only two acceptable POCs on the market (Inogen 
and Airsep) and we cannot predict how future products may be developed 
and work. Accordingly, 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. It is only under exceptionally rare 
circumstances that the FAA would permit a specific product to be used 
in a regulation. However, we believe such an approach is appropriate in 
this case until such time that a performance-based standard can be 
developed because the rule accommodates individuals who would otherwise 
be unable to fly. This approach is consistent with the Department of 
Transportation's desire to reduce travel barriers to persons with 
disabilities.

Reference Material

    After reviewing the, ``United Kingdom Civil Aviation Authority 
study titled ``Dealing With In-Flight Lithium Battery Fires in Portable 
Electronic Devices'', and recent incident data detailing battery abuse 
and short circuit problems associated with the carriage of batteries, 
it became clear that we must provide a means for reducing the hazard of 
personal injury and fire from loose POC batteries included as carry on 
items in passengers' carry-on baggage. Although most battery pack 
manufacturers employ various protective devices to prevent abuse such 
as thermal or pressure disconnects and shutdown separators to prevent 
battery overheating and fires, abuse conditions such as physical damage 
to the cell(s) or external short circuits do occur. Abuse of the 
battery can cause those safeguards to become ineffective unless other 
protective measures, such as battery outer protective packaging, are 
used. (See the discussion under the subtopic heading ``Safety of 
Carrying Multiple Batteries'' under the main topic heading ``Discussion 
of Comments'' below).

Related Activity

    The FAA's Office of Security and Hazardous Materials is 
coordinating with the Office of Hazardous Materials Safety in the DOT's 
Pipeline and Hazardous Materials Safety Administration (PHMSA) to 
examine battery safety. More specifically, PHMSA is considering a 
rulemaking that is aimed at preventing short circuit, sparking, and 
heat from all batteries and battery-powered devices in transportation. 
No formal or official rulemaking has begun at the time this SFAR is 
being published.

Discussion of Comments

    The NPRM leading to this final rule was published in the Federal 
Register on July 14, 2004. We set a 30-day comment period ending on 
August 13, 2004. The Air Transport Association (ATA) requested that we 
extend the comment period for an additional 60 days to allow more time 
to examine the proposal and submit appropriate comment. After reviewing 
the ATA's request, we determined that they misunderstood the proposal 
and that such a significant extension would unnecessarily delay the 
final decision on this rule. We extended the comment period an 
additional 15 days to allow additional time to review and analyse the 
proposal.
    The new comment period closed on August 30, 2004. As of September 
8, 2004, we had received about 2,270 comments. All comments submitted 
after the comment period closing date were considered in this final 
rule.
    Support for this proposed SFAR was overwhelming. Of the 2,270 
comments, 2,267 favored at least the spirit of our proposal. Commenters 
had many substantive and helpful comments that suggested changes to our 
original proposal. Many of the comments were used to draft our Final 
Rule, a product that benefits greatly from the thought and detail put 
into the comments.
    A large majority of the comments in favor of our proposal were form 
letters organized by a number of interest groups supporting the SFAR. 
We also received approximately 40 letters with extensive substantive 
comments, including questions, comments, suggestions, and ideas. We are 
responding to both the suggestions found in the form letters, as well 
as the ideas and suggestions found in the 40 letters with extensive 
substantive comments.
    We asked for comments on the following questions in the NPRM:
    1. Should the aircraft operator be required to inform the user 
about the availability of electrical outlets suitable for the Airsep 
portable oxygen concentrator?
    2. Should the user be required to carry batteries for the duration 
of the flight including reasonable delays if there are electrical 
outlets available on the flight?
    3. Are the meanings of the terms ``anticipated delay'' and 
``reasonable delay'' sufficiently clear?

Question 1. Use of Electrical Power

    Potential travellers commented in support of the aircraft operator 
informing the travelling public of the availability of electrical 
outlets on board

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aircraft. Potential travellers requiring oxygen therapy stated that 
other passengers routinely plug a laptop computer or other 
entertainment device into the aircraft's power supply, so a POC user 
should be given the same opportunity. Some commenters feel that a POC 
user should be given priority over all users of other types of portable 
electronic equipment.
    In contrast, industry and air carrier comments (including American 
Trans Air and the Air Transport Association) strongly objected to 
informing passengers of the availability of electrical outlets to power 
a POC. These commenters stated that electrical outlets are not widely 
available on the aircraft and that a carrier cannot guarantee access to 
an outlet because outlets may not be available for a particular seat 
assignment or, aircraft without outlets may be substituted unexpectedly 
for aircraft with outlets. Additionally, these commenters noted that 
some electrical outlets are designed to shut off automatically if the 
aircraft experiences electrical overload conditions. Any of these 
scenarios would create a problem for a POC user that had planned on 
using the aircraft's electrical supply and had not brought an 
appropriate number of batteries. American Trans Air was concerned with 
passengers being allowed to plug anything into the ship's power because 
it could open a ``Pandora's Box.''
    FAA Response: The FAA agrees that if aircraft operators obtain FAA 
authorization, access to the electrical power supply of the aircraft 
can be made available for a POC user, but it is not requiring the 
operator to inform the passenger about the availability of electrical 
outlets. There are too many variables that may change before the flight 
that could affect the availability of electrical outlets. If carriers 
wish to provide such information to potential POC users it is their 
choice to do so. The FAA does not have the authority under the Air 
Carrier Access Act to require such an action.
    If, for example, an operator of a transport category airplane 
provides a passenger access to aircraft electrical power for use with a 
POC, the operator must ensure that the installation and cabling, up to 
the point where the passenger plugs in the POC, meets the airworthiness 
standards of 14 CFR 25.1301, 25.1309, 25.1353, and 25.1357. These 
sections ensure that the wiring and circuit protection are sufficient 
for the intended use. The sections also ensure that the POC will not 
negatively affect aircraft power.
    In regard to the issue about giving POC users priority to use any 
available electrical outlets over people who are not using POCs, the 
Department of Transportation (DOT), under the Air Carrier Access Act, 
would have to assess whether the law requires a POC user to have such 
priority access.

Question 2 and 3. Number of Batteries in Carry-on To Address 
Anticipated or Reasonable Delay

    In the NPRM we asked whether the user should be required to carry 
batteries for the duration of the flight, including enough to cover 
reasonable delays if there are electrical outlets available on the 
flight. We also asked whether the terms ``anticipated delay'' and 
``reasonable delay'' were sufficiently clear to a user to enable them 
to make the decision as to how many batteries would be needed.
    Most commenters felt that those terms were not sufficient to 
determine the number of batteries that would be necessary in the event 
of any type of delay. Some suggested we simply require enough batteries 
to cover 150% of the flight time. Airbus commented that the user should 
be responsible for carrying the appropriate number of batteries to 
cover for delays, even if there are electrical outlets available on the 
aircraft. Airbus specifically notes that the outlets can only serve as 
backup for the devices under certain conditions because they will not 
always be available, and can be limited in power rating (typically 
around 75 Watts).
    FAA Response: The FAA does not believe that simply adding 150% to 
the scheduled flight time is adequate to cover the number of batteries 
that may be needed by an oxygen dependent passenger. Flight time in the 
Official Airline Guides, for example, only accounts for the usual time 
between aircraft pushback at the departure airport gate and the 
aircraft's arrival at the gate at the destination airport. It does not 
account for delays that occur after passengers are boarded at the 
departure gate; after pushback from the departure gate but before 
takeoff; during in-flight holding at the arrival airport awaiting 
landing clearance; as a result of flight to a diversion airport due to 
either adverse weather conditions at the planned destination airport or 
an aircraft emergency; and after landing at the planned destination 
airport. Scheduled travel time then would not appear, in our eyes, to 
account for all contingencies during travel. For example, time spent on 
the ground prior to departure and while awaiting arrival at a gate can 
easily exceed an hour. Weather delays commonly exceed an hour if the 
weather conditions at the departure or planned destination airports 
cause air traffic instrument flight rules aircraft separation criteria 
to be increased at peak airport departure and arrival times. Under the 
150% flight time increase comment, a 2 hour flight would only require 
enough batteries to power the POC for 3 hours. Under that scenario, a 
weather delay of an hour coupled with normal ground time, could easily 
drain the battery power before the trip was completed.
    The passenger's physician can help the passenger determine how much 
oxygen the patient may need on a flight. The physician, in the 
physician statement, can note whether the passenger needs oxygen for 
the entire air travel time, including ground and in-flight delays, or 
only portions of those times. It is then up to the user to carry the 
number of extra batteries necessary to cover the possible 
contingencies.

Generic Standard or Manufacturer Specific

    Many commenters, including Inogen, Inc., the Paralyzed Veterans of 
America, National Home Oxygen Patients Association, and the American 
Thoracic Society, requested that we not limit POCs by specific brand or 
manufacturer. These commenters wanted a generic standard that would 
apply to different types of devices. Over 150 commenters, however, 
asked that if we did limit the POC by manufacturer we include the 
Inogen One POC in the SFAR. Overall, there was broad support for 
writing a rule that would provide standards for a manufacturer to meet 
in order to have an acceptable model of POC.
    FAA Response: As noted in the NPRM, the FAA was reviewing the 
Inogen One POC and accompanying material at the time of the NPRM's 
publication. The FAA's review and evaluation had to be completed prior 
to determining whether the Inogen One POC would be eligible to be 
operated as a POC, as well as a portable electronic device for use 
onboard aircraft. Since the issuance of the NPRM, we have completed our 
review of the Inogen POC and we agree with commenters that the Inogen 
One device is functionally similar to the AirSep POC and should be 
included in the Final Rule. The FAA has determined that this device may 
be operated onboard aircraft, subject to certain conditions in the 
regulation, and the SFAR will include this device along with the Airsep 
Lifestyle POC.
    We agree that future rulemaking should include generic standards 
that future POC's would be required to meet. Since this future 
rulemaking will require time to develop the standards, the FAA will 
proceed, in the interim, with this SFAR. This SFAR is the

[[Page 40159]]

quickest way to enable the use of these two devices by passengers who 
have a medical need to continue to receive oxygen therapy during their 
air travel. The FAA will create a generic standard for all POCs that 
will be the basis for a follow-on rulemaking that will amend 14 CFR 
permanently. This SFAR is intended to be the first step in allowing 
passenger-furnished POC devices to be used on aircraft.

Role of FAA and RSPA (Now PHMSA) in Determining a Material 
``Hazardous''

    Several commenters asked specifically about a statement we included 
in the NPRM that pertained to the review and approval process for 
devices that may be considered non-hazardous by RSPA (now PHMSA) and 
whether or not the FAA can overrule PHMSA on such a determination.
    FAA Response: The two steps in the process, while related, are not 
exclusively connected to one another. A PHMSA determination that a 
medical oxygen device is not regulated as a hazardous material does not 
automatically qualify such a device as safe for use in air commerce. 
The FAA also must review and evaluate the device to determine if there 
are any additional safety concerns pertaining to the use of the product 
on board an aircraft. A ruling by the FAA that such a device cannot be 
carried on board an aircraft, however, does not mean that the device is 
a hazardous material under PHMSA's regulations in Title 49.

Requiring Airlines To Permit the Use of POCs

    Another commenter requested that we ``require'' aircraft operators 
to allow passengers needing oxygen therapy to carry on and operate the 
POCs onboard aircraft. The NPRM only stated that operators may choose 
to allow passengers on oxygen therapy to carry on and operate the 
devices onboard their aircraft.
    FAA Response: The FAA does not have the statutory authority under 
the Air Carrier Access Act to require air carriers to allow these 
devices to be carried or operated onboard their aircraft. That 
authority is granted only to the Department of Transportation (DOT). It 
is DOT's decision whether or not to designate these devices as 
assistive devices, and to require air carriers to allow the transport 
of these devices and, in conjunction with the FAA, require air carriers 
to allow passenger operation of these devices onboard aircraft. This 
SFAR will open the door for air carriers to take advantage of the new 
market available through passenger use of these devices.

Use of POCs During Takeoff and Landing and Passenger Movement in Flight

    Commenters wanted to make sure that our rule allowed passengers 
using a POC to operate the device for the entirety of the flight if 
necessary. Many oxygen users' physicians may stipulate that there is a 
medical need for their patients to use a POC during the entire flight, 
including movement on the surface, takeoff, and landing. Movement on 
the surface, takeoff, and landing are times when the current 
regulations require that, among other things, medical oxygen equipment 
be properly stowed, and each person using the equipment to be seated at 
a seat location that does not restrict passenger access to, or use of, 
any required exit (emergency or regular), or the aisle(s) in the 
passenger compartment.
    FAA Response: This final rule will allow passengers to use a POC 
during the flight, including movement on the surface, takeoff, and 
landing. Additionally, once passengers are allowed to move about the 
cabin of the aircraft, they will be allowed to carry a POC along with 
them. This allowance is specifically cited in the new Section 3(a)(6) 
in the regulatory text of this final rule.
    A new section was also included in the regulatory text that 
requires the physician statement to include information on the extent 
to which the user must use the portable oxygen concentrator (e.g., 
During takeoff and landing only, during the whole flight, only when 
needed, etc.)

Safety of Carrying Multiple Batteries

    One commenter raised concerns about the safety of carrying multiple 
extra batteries in carry-on baggage to be used to power the POC.
    FAA response: This commenter's concerns are shared by the FAA. We 
are adopting the requirement that passengers whose physician statement 
stipulates a medical need for extensive oxygen use must carry enough 
extra batteries to power the POC for the duration of time the passenger 
may be on board the aircraft.
    Comments received in response to the NPRM stated that the battery 
life for the AirSep Lifestyle POC is approximately 50 minutes, while 
the Inogen One has a battery life of approximately 2 to 3 hours. Since 
the battery life for these devices is so short, it is likely that 
passengers using these devices may have to carry many extra batteries 
onboard the aircraft in order to comply with their physician's oxygen 
prescription. The number of extra batteries must be able to power the 
POC in the event the aircraft operator does not permit these devices to 
be powered by the aircraft electrical system, or the aircraft 
electrical system is inoperative or otherwise unusable.
    Therefore, the FAA is including a new section in the SFAR. Section 
3(b)(6) requires the user to ensure that all POC batteries carried 
onboard aircraft as carry-on baggage are protected from short-circuit 
problems, and are packaged in a manner that protects them from physical 
damage. Protection from short-circuit problems may be provided by 
batteries designed with recessed battery terminals or by packaging that 
keeps the battery terminals from contacting metal objects (including 
the battery terminals of other batteries). When a battery-powered 
oxygen concentrator is carried onboard aircraft as carry-on baggage and 
is not intended to be used during flight, the battery must be removed 
and packaged separately, unless the concentrator contains at least two 
effective protective features to prevent accidental operation and 
battery overheating during transport.
    The passenger will be responsible for ensuring that all extra 
batteries carried in carry-on baggage are properly packaged, but we do 
not envision passengers packaging the batteries themselves.
    A POC manufacturer may not be able to develop a product to meet the 
packaging standard in this SFAR by the time the rule becomes effective 
(30 days after publication). However, the battery packaging standard 
contained in the regulatory language of this SFAR must be met before 
the extra batteries will be allowed as carry-on baggage onboard the 
aircraft. Companies with experience meeting shipping standards will 
likely be able to assist a passenger to meet this standard.
    We believe passengers can also arrange for the following entities 
to package extra POC batteries to meet the standard:

--Homecare providers;
--Airlines;
--Other entities specializing in small package shipments.

    As for the POC itself, we anticipate the homecare provider would be 
able to prepare the device for transport.
    There is a history of battery problems with other portable 
electronic devices when a battery is being charged during flight. We 
currently do not have data to establish a limit on the recharging of 
POC batteries during flight. Therefore, if the aircraft electrical 
system is available to recharge a POC battery, it is currently 
permissible to do so under this SFAR.

[[Page 40160]]

    In the future, the FAA may consider developing a technical standard 
order (TSO) to reduce the risk of overcharging for certain types of 
rechargeable batteries in portable electronic devices that are carried 
in the aircraft passenger compartment.

Battery Backup for the POC in the Event of Failure

    Some comments we received asked what sort of contingency or 
emergency precautions would be taken if a POC were to fail during the 
flight, or if battery power ran out during the flight. The American 
Association for Respiratory Care suggested that, if a POC malfunctions, 
the flight crew should provide the user access to supplemental oxygen 
from the emergency oxygen source. The National Home Oxygen Patients 
Association also supports the idea of consulting with the patient if a 
POC fails, and relying on the emergency medical oxygen that would be 
available if an airline-provided oxygen system were to fail. Access to 
the aircraft's emergency oxygen would eliminate the need to divert the 
flight in many instances.
    FAA Response: We agree that the appropriate action, in case of 
aircraft electrical power or battery failure, would be to refer to the 
passenger's physician statement and consult with the passenger using 
the POC. The crewmember should determine, through the statement and 
discussion, the person's medical need for oxygen use and provide access 
to the aircraft's first aid oxygen equipment if necessary. However, it 
should be noted that only aircraft required to be operated under 14 CFR 
part 121 are required to be equipped with first aid oxygen equipment. 
We do not feel it is necessary to include this particular detail in 
this SFAR, but strongly encourage the aircraft operator to make the 
availability of first aid oxygen equipment clear to the passengers who 
may have a medical need for it. We also encourage passengers who have a 
medical need for lengthy periods of oxygen use to ensure that this 
equipment is available before arranging for a flight.

Application of RTCA/DO-160D, Section 21, Category M (Classified as a 
Medical-Portable Electronic Device)

    We received comments with concern to section 3(a)(1) of the 
proposed rule that required the aircraft operator to ensure that a POC 
does not interfere with electrical, navigation, or communication 
equipment on which the device is being used. Several commenters felt 
that this requirement may mean that each aircraft operator had to test 
each device for every model of aircraft they are flying to see if it is 
safe. For instance, as the joint comment headed by the American 
Thoracic Society noted, the requirement would seem to mean that if U.S. 
Airways tested the POC device on a Boeing 747 and found that there was 
no interference, Delta Airlines would still have to test the same 
device on the same model of aircraft for themselves. The Air Transport 
Association echoed the question, and sought some answers about whether 
or not the FAA's Advisory Circular (AC) 91.21-1A would be applicable to 
a POC. If the POC were tested to the standard established for a 
medical-portable oxygen device (M-PED) contained in RTCA Document DO-
160D, would that be acceptable to meet the requirement of section 
3(a)(1) of the SFAR?
    FAA Response: A POC, whether it is the Inogen One or the AirSep 
Lifestyle, is considered a medical-portable electronic device (M-PED), 
and thus is eligible to meet the standards contained in RTCA DO-160D. 
Both devices fall under the scope of AC 91.21-1A, and each manufacturer 
can test their device to the standard called for in the AC. It must be 
clear though that the requirement found in section 3(a)(1) remains 
applicable to the aircraft operator. If a POC manufacturer tests the 
device to meet the RTCA standard and shows that it meets the standard, 
the manufacturer may provide the positive testing results to the 
aircraft operator on the POC itself. The aircraft operator will have to 
be able to show that the device has been tested and meets the 
applicable standard regardless of the test method used.
    If either the Inogen or AirSep POC have been tested to meet the 
RTCA standard found in AC 91.21-1A, and the test results are provided 
to, and verified by, the aircraft operator, no further testing by the 
aircraft operator would be required.

POC as Carry on Baggage

    We received comments from several interested parties, including the 
American Association for Respiratory Care, the American Thoracic 
Society, the Pulmonary Hypertension Association, and others that 
requested we allow passengers to bring two carry-on bags if they are 
using a POC on the flight. Their recommendation would not include the 
POC itself as one of those carry-on items, only the regular carry-on 
baggage common for most travellers, and the extra batteries that will 
be necessary for each flight.
    FAA Response: The FAA does not agree with the recommendations of 
the commenters. Because aircraft operators' aircraft passenger 
compartment configurations have differing capability to accommodate the 
safe stowage of different sizes and amounts of carry-on baggage, the 
FAA cannot simply establish a requirement in its regulations that, 
henceforth, aircraft operators subject, for example to the requirements 
of 14 CFR 121.589, must allow POC users to bring into the passenger 
compartment, two carry-on bags and the extra POC batteries in addition 
to their POC. The FAA's regulations pertaining to the carriage of 
carry-on baggage in passenger compartments of aircraft, 14 CFR 91.523, 
91.525, 121.285, 121.589, 125.183, and 135.87, provide that no aircraft 
operator may allow the carriage of carry-on baggage on its aircraft 
unless the applicable requirements prescribed by those regulations are 
met.
    The FAA plans to provide information about the size and weight of 
the POCs covered by this SFAR to aircraft operators. This information 
may cause certain operators to review their carry-on baggage programs 
to determine whether they may be able to accommodate the carriage of 
the POCs.

Liquid Oxygen Devices Onboard Aircraft

    We received several comments, mostly from individual commenters--
not from industry or interest groups, asking why we couldn't also allow 
passengers to use the Helios liquid oxygen device, or other devices 
using a liquid oxygen supply.
    FAA Response: Liquid oxygen is classified as a hazardous material 
by the Department of Transportation's hazardous materials regulations 
(49 CFR, parts 100-185). Paragraph 175.85(a) of 49 CFR prohibits 
passengers from carrying hazardous materials in the cabin of the 
aircraft. The Office of Hazardous Materials Safety of the U.S. DOT 
Pipeline and Hazardous Materials Safety Administration (PHMSA) is the 
responsible office for this regulation. Those seeking change to or 
relief from this regulation should address their concerns to PHMSA. At 
this writing, we are aware that the manufacturer of the Helios portable 
liquid oxygen device is seeking an exemption from PHMSA to allow 
passengers to carry on the Helios device on passenger-carrying 
aircraft. If PHMSA issues an exemption to its regulations, the 
manufacturer of the Helios device still would need to petition the FAA 
for an exemption to the SFAR, or for an amendment to the SFAR to permit 
the use of this liquid

[[Page 40161]]

oxygen device on board aircraft. Existing FAA regulations (e.g., 
Sections 121.574(a)(2); 125.219; 135.91) restrict the use of liquid 
oxygen to those devices furnished by the aircraft operator itself.

Pilot in Command Notification

    We received a comment from the National Home Oxygen Patients 
Association that asked us to clarify the section in the NPRM that 
required the aircraft operator to ensure that the pilot in command be 
apprised of a passenger using a POC. This section, section 3(a)(10) in 
the NPRM, read, ``The pilot in command must be apprised when a 
passenger is using a portable oxygen concentrator.'' The comment asked 
if this meant that the pilot was to be informed when a passenger 
brought a POC onboard the aircraft and intended to use it during the 
flight, or if the pilot was to be informed specifically when a POC is 
turned on and off. The comment goes on further to question why it is 
necessary to inform the pilot that the device is onboard at all, and 
whether or not the physician letter required by the NPRM is an 
appropriate notification to the aircraft operator.
    FAA Response: The intent of this section, now section 3(a)(5) in 
this final rule, is to make sure that the pilot in command is informed 
that a POC has been brought on the aircraft and the passenger's 
physician statement states that the passenger has a medical need for 
oxygen for a substantial portion of the duration of the flight. It is 
necessary for the pilot in command to know this information because of 
the possibility the device will fail and the user may have a medical 
emergency requiring emergency action on the part of the flight crew. 
Also, if a POC is using the electrical power of the aircraft as its 
main power source, the pilot will benefit from the knowledge and be 
able to announce and inform users if the use of that power needs to be 
restricted during the flight.
    The physician's statement is appropriate to inform the aircraft 
operator that a passenger is carrying a POC onboard the aircraft with 
the intent to use it. The requirement found in section 3(a)(5) of this 
SFAR addresses only what the aircraft operator must do when allowing 
the POCs onboard for a flight.

Ability To See and Hear a POC Alarm and React

    Some commenters, including the National Home Oxygen Patients 
Association, recommended that we require the physician to determine 
whether a user is able to see and/or hear the alarm on a POC and 
respond appropriately. Others asked, with reference to this requirement 
in the NPRM, how the aircraft operator could appropriately ensure that 
a passenger would be able to meet the requirement to see and hear the 
alarms. Aircraft operators opposed the requirement that they be 
responsible for assessing the ability of a passenger to see and hear an 
alarm and react appropriately because they felt their employees are not 
qualified to make such an assessment.
    FAA Response: In the NPRM, we proposed that the aircraft operator 
be responsible for ensuring that the passenger using a POC onboard the 
aircraft could see or hear the alarm if it activated on the device, and 
be able to respond to the alarm appropriately. We agree with the 
industry comments that said this requirement was too difficult for the 
aircraft operator to implement. We also agree with the commenters that 
such an assessment is more appropriately completed by the prescribing 
physician. We also agree with the National Home Oxygen Patients 
Association, and others, that this statement must be part of the 
required information in the physician statement in section 3(b)(3) of 
this SFAR. In addition to the information added to the physician 
statement in section 3(b)(3), the proposed requirement in section 
3(a)(3) is adopted with modification in section 3(b)(1) of this SFAR.

Amend Proposal To Make Passenger Responsible for Complying With Certain 
Conditions

    In the NPRM, we outlined specific conditions that the aircraft 
operator would be responsible for in order to allow a passenger to 
carry on and operate a POC onboard the aircraft. We received several 
comments from air carriers and groups representing air carriers that 
objected to many of the responsibilities placed on them under section 
3(a) in the NPRM. Specifically, there was objection to each of the 
following conditions under section 3(a) beginning with (a) 2: Section 
3. Operating requirements--
    (a) The AirSep Lifestyle Portable Oxygen Concentrator unit may be 
used by a passenger on board an aircraft provided the operator ensures 
that the following conditions are satisfied:
* * * * *
    (2) The unit must be turned off if the nasal cannula is not 
positioned for oxygen delivery to the user;
    (3) The user must be capable of seeing the alarm indicator lights, 
hearing the various warning alarms, and taking the appropriate action 
should the unit fail to detect the user's breathing or a general 
malfunction occurs, or is travelling with someone who is capable of 
performing those functions for the user;
* * * * *
    (5) The air intake/gross particle filter or the air outlet must not 
be blocked during use;
* * * * *
    (8) The portable oxygen concentrator must be free from oil, grease, 
or other petroleum products and be in good condition free from damage 
or other signs of excessive wear or abuse;
    (9) The number of hours before maintenance must be below 3,000 at 
the end of the scheduled flight time for that flight leg.
    FAA Response: In response to comments, we are amending the 
requirements placed on the operator and, instead, placing these 
requirements on the passenger. As a result, we are removing the 
requirements on aircraft operators proposed in section 3(a)(2), (3), 
(5), (8), and (9), and transferring some of those conditions to the 
passenger outlined in section (3)(b). See the FAA's response under the 
topic heading ``Ability to see and hear a POC alarm and react'' as 
discussed above.
    We have expanded the section that requires the passenger to carry a 
physician statement to clarify what needs to be included in the 
statement. We would also like to make it clear that a new physician 
statement will not be necessary for each flight a passenger takes. A 
single physician statement that includes all of the information 
required in section 3(b)(3) can be used for all future flights.

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 this final rule 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 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. Comments with respect to these 
two requirements

[[Page 40162]]

in the rule were received and addressed in the Discussion of Comments 
above.
    We estimate that an average of 44,500 physician statements would be 
filed annually. It is estimated to take 5 minutes, or 0.083 hours, to 
complete each written statement. Hence, the estimated annual hour 
burden for the first year, and over the next ten years, are estimated 
to be:
    First Year: 0.083 hours x 400,000 = 33,200 hours.
    Years 2-10: 0.083 hours x 5,000 = 415 hours.
    Annual Hour Burden: .083 x 44,500 = 3,693.5 hours.
    The average loaded hourly wage for a physician is $65.32. Thus, the 
estimated average annual cost of obtaining a physician's statement is 
estimated to be:
    First Year: $65.32 x 33,200 = $2,168,624.
    Years 2-10: $65.32 x 415 = $27,108.
    Annual Cost Burden: $65.32 x 3,693.5 = $241,259.
    We estimate that in a typical year, passengers affected by this 
final rule would make about 1,690,000 flights per year. On each flight 
either a flight attendant or a gate agent would notify the pilot in 
command that a POC would be in use during flight. We estimate that it 
will take five minutes for the flight attendant or gate agent, to 
notify the pilot in command, and one minute for the pilot to record it.
    Annual Time for Flight Attendant/Gate Agent: .083 x 1,690,000 = 
140,270 hours.
    Annual Time for Pilot in Command: .017 x 1,690,000 = 28,730 hours.
    The average loaded hourly wage rate for a Flight Attendant/Gate 
Agent is estimated to be $23.97, and the average loaded hourly wage 
rate for a pilot in command is estimated to be $121.56.
    Annual Cost for Flight Attendant/Gate Agent: $23.97 x 140,270 = 
$3,362,272.
    Annual Cost for Pilot in Command: $121.56 x 28,730 = $3,492,419.

Cost Summary

    In summary, this final rule is estimated to have a total hour 
burden of 2,135,000 hours, and estimated total costs of $70,959,901, 
which correlates to an estimated annual burden of 213,500 hours, and an 
estimated annual cost of $7,095,950.

                                           Summary of Paperwork Costs
----------------------------------------------------------------------------------------------------------------
                     Action                         Total hours     Total costs    Annual hours     Annual cost
----------------------------------------------------------------------------------------------------------------
Obtaining Physician's Statement.................          36,935      $2,412,594         3,693.5        $241,259
Notifying PIC...................................       1,690,000      68,546,907         169,000       6,854,691
                                                 -----------------
    Totals......................................       1,726,935      70,959,501       172,693.5       7,095,950
----------------------------------------------------------------------------------------------------------------

    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 OMB Control Number 
associated with this collection is 2120-0702.

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 has 
determined that there are no ICAO Standards and Recommended Practices 
that correspond to these regulations.

Economic Assessment, Regulatory Flexibility Determination, 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 requires agencies to analyze the 
economic impact of regulatory changes on small entities. Third, the 
Trade Agreements Act (19 U.S.C. 2531-2533) 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, to 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).
    In conducting these analyses, FAA has determined this rule: (1) Has 
benefits that justify its costs, 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; (2) will not have a significant economic impact on a 
substantial number of small entities; (3) will not affect international 
trade; and does not impose an unfunded mandate on state, local, or 
tribal governments, or on the private sector. These analyses, available 
in the docket, are summarized below.

Costs and Benefits of the Rule

    The rule is estimated to cost about $79.9 million (or $58.1 million 
discounted) over the next ten years. The rule will also result in 
potential cost savings because passengers will have an option of using 
a POC onboard an airplane other than renting oxygen from the carrier.

Who Will Be Potentially Affected by the Rule

    The rule will affect people who use POCs on airplanes.

Our Cost Assumptions

    Covers the years 2006-2015.
    All monetary values are expressed in 2004 dollars.
    Discount rate--7%.
    The packaging for batteries costs an average of $10, and holds up 
to 3 batteries.
    Users of the AirSep POC will purchase three packages, and users of 
the Inogen POC will purchase one package.
    Each effected passenger makes at least one round trip flight, per 
year, with at least one stop in each direction for a total of four 
separate flights.

Final Regulatory Flexibility Determination

    The Regulatory Flexibility Act of 1980 (RFA) establishes ``as a 
principle of regulatory issuance that agencies shall endeavor, 
consistent with the objective of the rule and of applicable statutes, 
to fit regulatory and informational requirements to the scale of the 
business, organizations, and governmental jurisdictions subject to 
regulation.'' To achieve that principle,

[[Page 40163]]

the RFA requires agencies to solicit and consider flexible regulatory 
proposals and to explain the rationale for their actions. 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 proposed or 
final rule will have a significant economic impact on a substantial 
number of small entities. If the determination is that it will, the 
agency must prepare a regulatory flexibility analysis as described in 
the RFA.
    However, if an agency determines that a proposed or final 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 rule does not affect small businesses, since it does not 
require small entities to allow passengers to use POCs, rather it has a 
direct effect on individuals. Accordingly, pursuant to the Regulatory 
Flexibility Act, 5 U.S.C. 605(b), the Federal Aviation Administration 
certifies that this final rule will not have a significant impact on a 
substantial number of small entities.

International Trade Impact Assessment

    The Trade Agreements Act of 1979 prohibits Federal agencies from 
establishing any standards or engaging in related activities that 
create unnecessary obstacles to the foreign commerce of the United 
States. Legitimate domestic objectives, such as safety, are not 
considered unnecessary obstacles. The statute also requires 
consideration of international standards and where appropriate, that 
they be the basis for U.S. standards.
    In accordance with the statute, the FAA has assessed the potential 
affect of this final rule and has determined that it will have only a 
domestic impact and therefore it will not affect on any trade-sensitive 
activity.

Unfunded Mandates Reform Act Assessment

    The Unfunded Mandates Reform Act of 1995 (the Act) 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 expenditure of $100 million or more (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 $120.7 million in lieu of $100 
million.
    This final rule does not contain such a mandate. The requirements 
of Title II 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, and therefore does not have federalism implications.

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 312d 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 (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.

List of Subjects

14 CFR Part 11

    Administrative practice and procedure, Reporting and recordkeeping 
requirements.

14 CFR Part 121

    Air carriers, Aircraft, Airmen, Aviation safety, Charter flights, 
Safety, Transportation, Air taxis.

The Amendment

0
In consideration of the foregoing, the Federal Aviation Administration 
amends part 11 of Title 14, Code of Federal Regulations, of Title 14, 
Code of Federal Regulations, and adds SFAR No. 106 to Chapter II of 
Title 14, Code of Federal Regulations, as follows:

PART 11--GENERAL RULEMAKING PROCEDURES

0
1. The authority citation for part 11 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 40101, 40103, 40105, 40109, 40113, 
44110, 44502, 44701-44702, 44711, and 46102.

Subpart B--Paperwork Reduction Act Control Numbers

0
2. Amend the table in Sec.  11.201(b) by revising the entry for part 
121 to read as follows:


Sec.  11.201  Office of Management and Budget (OMB) control numbers 
assigned under the Paperwork Reduction Act.

* * * * *
    (b) * * *

------------------------------------------------------------------------
    14 CFR part or section
   identified and described             Current OMB Control No.
------------------------------------------------------------------------
 
                              * * * * * * *
Part 121.....................  2120-0008, 2120-0028, 2120-0535, 2120-
                                0571, 2120-0600, 2120-0606, 2120-0614,
                                2120-0616, 2120-0631, 2120-0651, 2120-
                                0653, 2120-0691, 2120-0702
 
                              * * * * * * *
------------------------------------------------------------------------


[[Page 40164]]

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

0
3. The authority citation for this SFAR shall 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
4. Special Federal Aviation Regulation No. 106 is added to read as 
follows: SPECIAL FEDERAL AVIATION REGULATON NO. 106. RULES FOR USE OF 
PORTABLE OXYGEN CONCENTRATOR SYSTEMS ON BOARD AIRCRAFT.
    Section 1. Applicability--This rule prescribes special operating 
rules for the use of portable oxygen concentrator units on board civil 
aircraft. This rule applies to both the aircraft operator and the 
passenger using the portable oxygen concentrator on board the aircraft.
    Section 2. Definitions--For the purposes of this SFAR the following 
definitions apply: Portable Oxygen Concentrator: means the AirSep 
Lifestyle or Inogen One Portable Oxygen Concentrator medical device 
units as long as those medical devices 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; (3) provide oxygen therapy through pulse 
technology; and (4) 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 LifeStyle 
Portable Oxygen Concentrator and Inogen One 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:
    (1) The device does not cause interference with the electrical, 
navigation or communication equipment on the aircraft on which the 
device is to be used;
    (2) No smoking or open flame is permitted within 10 feet of any 
seat row where a person is using a portable oxygen concentrator.
    (3) During movement on the surface, takeoff, and landing, the unit 
must:
    (i) Either be stowed under the seat in front of the user, or in 
another approved stowage location, so that it does not block the aisle 
way or the entryway into the row; or
    (ii) If it is to be operated by the user, be used only at a seat 
location that does not restrict any passenger's access to, or use of, 
any required emergency or regular exit, or the aisle(s) in the 
passenger compartment;
    (4) No person using a portable oxygen concentrator is permitted to 
sit in an exit row;
    (5) The pilot in command must be apprised whenever a passenger 
brings and intends to use a portable oxygen concentrator on board the 
aircraft and the pilot in command must be informed about the contents 
of the physician's written statement (as required in Section 3(b)(3) of 
this SFAR), including the magnitude and nature of the passenger's 
oxygen needs.
    (6) Whenever the pilot in command turns off the ``Fasten Seat 
Belt'' sign, or otherwise signifies that permission is granted to move 
about the passenger cabin, passengers operating their portable oxygen 
concentrator may continue to operate it while moving about the cabin.
    (b) The user of the portable oxygen concentrator must comply with 
the following conditions to use the device on board the aircraft:
    (1) The user must be capable of hearing the unit's alarms, seeing 
the alarm light indicators, and have the cognitive ability to take the 
appropriate action in response to the various caution and warning 
alarms and alarm light indicators, or be travelling with someone who is 
capable of performing those functions;
    (2) The user must ensure that the portable oxygen concentrator is 
free of oil, grease or other petroleum products and is in good 
condition free from damage or other signs of excessive wear or abuse;
    (3) The user must inform the aircraft operator that he or she 
intends to use a portable oxygen concentrator on board the aircraft and 
must allow the crew of the aircraft to review the contents of the 
physician's statement. The user must have a written statement, to be 
kept in that person's possession, signed by a licensed physician that:
    (i) States whether the user of the device has the physical and 
cognitive ability to see, hear, and understand the device's aural and 
visual cautions and warnings and is able, without assistance, to take 
the appropriate action in response to those cautions and warnings;
    (ii) States whether or not oxygen use is medically necessary for 
all or a portion of the duration of the trip; and
    (iii) Specifies the maximum oxygen flow rate corresponding to the 
pressure in the cabin of the aircraft under normal operating 
conditions.
    (4) Only lotions or salves that are oxygen approved may be used by 
persons using the portable oxygen concentrator device;
    (5) The user, whose physician statement specifies the duration of 
oxygen use, must obtain from the aircraft operator, or by other means, 
the duration of the planned flight. The user must carry on the flight a 
sufficient number of batteries to power the device for the duration of 
the oxygen use specified in the user's physician statement, including a 
conservative estimate of any unanticipated delays; and
    (6) The user must ensure that all portable oxygen concentrator 
batteries carried onboard the aircraft in carry-on baggage are 
protected from short circuit and are packaged in a manner that protects 
them from physical damage. Batteries protected from short circuit 
include: (1) Those designed with recessed battery terminals; or (2) 
those packaged so that the battery terminals do not contact metal 
objects (including the battery terminals of other batteries). When a 
battery-powered oxygen concentrator is carried onboard aircraft as 
carry-on baggage and is not intended to be used during the flight, the 
battery must be removed and packaged separately unless the concentrator 
contains at least two effective protective features to prevent 
accidental operation during transport.
    Section 4. Expiration Date--This SFAR No. 106 will remain in effect 
until further notice.
* * * * *

    Issued in Washington, DC, on July 1, 2005.
Marion C. Blakey,
Administrator.
[FR Doc. 05-13664 Filed 7-11-05; 8:45 am]
BILLING CODE 4910-13-P