53954 Federal Register / Vol. 71, No. 176 / Tuesday, September 12, 2006 / Rules and Regulations 

DEPARTMENT OF TRANSPORTATION 

Federal Aviation Administration 

14 CFR Part 121 

[Docket No. FAA–2004–18596; SFAR 106] 

RIN 2120–AI81 

Use of Additional Portable Oxygen 

Concentrator Devices Onboard Aircraft 

AGENCY: Federal Aviation 

Administration (FAA), DOT. 

ACTION: Final rule. 

SUMMARY: This action amends Special 

Federal Aviation Regulation 106 (SFAR 

106), Use of Certain Portable Oxygen 

Concentrator Devices Onboard Aircraft, 

to allow for the use of the AirSep 

Corporation’s FreeStyle, SeQual 

Technologies’ Eclipse, and Respironics 

Inc.’s EverGo portable oxygen 

concentrator (POC) devices onboard 

aircraft, provided certain conditions in 

the SFAR are met. This action is 

necessary to allow all POC devices 

deemed acceptable by the FAA to be 

available to the traveling public in need 

of oxygen therapy for use in air 

commerce. When this rule becomes 

effective, there will be a total of five 

different POC devices the FAA finds 

acceptable for use onboard aircraft 

during travel, and passengers will be 

able to carry these devices onboard the 

aircraft and use them with the approval 

of the aircraft operator. 

DATES: This final rule amending SFAR 

106 will become effective on September 

12, 2006. 

FOR FURTHER INFORMATION CONTACT: 

David Catey, Air Transportation 

Division, Flight Standards Service, 

Federal Aviation Administration, 800 

Independence Avenue, SW., 

Washington, DC 20591. Telephone: 

(202) 267–3732. 

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 FAA’s Regulations and 

Policies Web page at http:// 

www.faa.gov/regulations_policies/; or 

(3) Accessing the Government 

Printing Office’s Web page at http:// 

www.gpoaccess.gov/fr/index.html. 

You can also get a copy by sending a 

request to the Federal Aviation 

Administration, Office of Rulemaking, 

ARM–1, 800 Independence Avenue 

SW., Washington, DC 20591, or by 

calling (202) 267–9680. Make sure to 

identify the amendment number or 

docket number of this rulemaking. 

Small Business Regulatory Enforcement 

Fairness Act 

The Small Business Regulatory 

Enforcement Fairness Act (SBREFA) of 

1996 requires FAA to comply with 

small entity requests for information or 

advice about compliance with statutes 

and regulations within its jurisdiction. 

Therefore, any small entity that has a 

question regarding this document may 

contact their local FAA official, or the 

person listed under FOR FURTHER

INFORMATION CONTACT. You can find out 

more about SBRFA 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 procedure 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. Prior 

to publication of SFAR 106, passengers 

in need of medical oxygen during air 

transportation faced many obstacles 

when requesting service. Many carriers 

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 air carriers and suppliers at 

airports was also difficult, and 

passengers frequently chose not to fly 

because of these difficulties. 

Recently, new medical oxygen 

technologies approved by the Food and 

Drug Administration (FDA) reduce the 

risks typically associated with 

compressed oxygen. Several 

manufacturers have developed small 

portable oxygen concentrators (POC) 

that work by separating oxygen from 

nitrogen and other gases contained in 

ambient air and dispensing it in 

concentrated form to the user with an 

oxygen concentration of about 90%. The 

POCs operate using either rechargeable 

batteries or, if the aircraft operator 

obtains approval from the FAA, aircraft 

electrical power. 

In addition, the Pipeline and 

Hazardous Materials Safety 

Administration (PHMSA) has 

determined that the POCs covered by 

this amendment are not hazardous 

materials. Thus, they do not require the 

same level of special handling as 

compressed oxygen, and are safe for use 

onboard aircraft, provided certain 

conditions for their use are met. 

SFAR 106 permits passengers to carry 

on and use certain POCs onboard 

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 are the AirSep LifeStyle 

and the Inogen One POCs. Aircraft 

operators can now offer medical oxygen 

service as they did before SFAR 106 was 

enacted, or they can arrange for 

passengers to carry on and use one of 

the 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 

devices onboard, but they may allow 

them to be operated onboard. If one of 

these devices is allowed by the aircraft 

operator to be carried on board, the 

conditions in the SFAR must be met. 

When SFAR 106 was published, the 

FAA committed to establishing a single 

standard for all POCs so that regulations 

wouldn’t apply to specific 

manufacturers and models of device. 

Whenever possible, the FAA tries to 

regulate by creating standards rather 

than approving by manufacturer. In the 

case of SFAR 106, the quickest and 

easiest way to serve both the customer 

and the air carrier 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 in 

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 SFAR 106 and 

published it so that passengers who 

otherwise could not fly could do so with 

an affordable alternative to what existed 

before SFAR 106 was published. 

We continue to pursue the 

performance-based standard for all 

POCs. This process is time-consuming 


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Federal Register / Vol. 71, No. 176 / Tuesday, September 12, 2006 / Rules and Regulations 53955 

and we intend to publish a notice in the 

Federal Register and offer the public a 

chance to comment on the proposal 

when it is complete. In the meantime, 

manufacturers continue to create new 

and better POCs, and several have 

requested that their product also be 

included as an acceptable device in 

SFAR 106. These new manufacturers 

include SeQual Technologies, Inc., and 

Respironics, Inc. AirSep Corporation, 

which manufactures the LifeStyle POC 

authorized for use under SFAR 106, has 

asked the FAA to authorize the use of 

its FreeStyle POC under SFAR 106 also. 

Each of these companies has formally 

petitioned the FAA for inclusion in 

SFAR 106 by submitting documentation 

of the devices to the Department of 

Transportation’s Docket Management 

System. That documentation is available 

at http://dmes.dot.gov under the 

following docket numbers: 

1. SeQual Technologies—FAA–2005–

22574. 

2. Respironics Inc., formerly OxyTec 

Medical Corporation—FAA–2006–

23678. 

3. AirSep Corporation—FAA–2006–

24912. 

As stated in Section 2 of SFAR 106, 

each covered device must not contain 

hazardous materials as determined by 

PHMSA (written documentation 

necessary), and 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. SeQual Technologies’ Eclipse 

Oxygen System; 

2. Respironics EverGo System; and 

3. AirSep Corporation’s FreeStyle 

Portable Oxygen Concentrator. 

The Rule 

This amendment to SFAR 106 will 

include the SeQual Eclipse, Respironics 

EverGo, and AirSep FreeStyle devices in 

the list of POCs authorized for use in air 

commerce. The FAA has reviewed each 

individual device and accepted the 

documentation provided by the three 

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 three devices were 

determined by the FAA to be acceptable 

for use in air commerce. 

Along with the inclusion of these 

three new devices in Section 2 of the 

SFAR, we amend the rule by removing 

the requirement that a POC provide 

oxygen therapy solely through the use of 

pulse technology. It was only after 

publication of SFAR 106 that we 

learned about a continuous flow feature 

of the SeQual Technologies Eclipse 

POC. The Eclipse POC features pulse 

delivery in addition to its continuous 

flow feature. Therefore, we find there is 

no safety reason for limiting POC 

acceptance to those POCs having only 

the pulse delivery feature. That 

requirement was formerly included in 

Section 2 of the SFAR and has been 

removed. 

Good Cause for Adoption of This Final 

Rule Without Notice and Comment 

As stated above, SFAR 106 was 

published on July 12, 2005. We stated 

in the preamble of that final rule that 

the AirSep LifeStyle and Inogen One 

POC devices were the only known 

acceptable devices when the rule was 

published. We also stated in that final 

rule that ‘‘we cannot predict how future 

products may be developed and work.’’

We initiated a notice and comment 

period for the use of POC devices 

onboard 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 not in the public interest 

to publish a notice to request comments 

on this amendment because all issues 

related to the use of POC devices 

onboard an aircraft have already been 

discussed. Further notice and comment 

would unnecessarily delay the 

acceptance of the AirSep FreeStyle, 

SeQual Eclipse, and Respironics EverGo 

POC devices as authorized for use 

onboard aircraft and included in SFAR 

106. 

Therefore, I find that notice and 

public comment under 5 U.S.C. 553(b) 

are impracticable 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 proposed 

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 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. 

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 

three 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 

Executive Order 12866, Regulatory 

Planning and Review, directs the FAA 

to assess both the costs and benefits of 

a regulatory change. We are not allowed 

to propose or adopt a regulation unless 

we make a reasoned determination that 

the benefits of the intended regulation 

justify its costs. Our assessment of this 

proposal indicates that its economic 

impact is minimal. Since its costs and 

benefits do not make it a ‘‘significant 

regulatory action’’ as defined in the 

Order, we have not prepared a 

‘‘regulatory impact analysis.’’ Similarly, 

we have not prepared a ‘‘regulatory 

evaluation,’’ which is the written cost/ 

benefit analysis ordinarily required for 

all rulemaking proposals under the DOT 


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53956 Federal Register / Vol. 71, No. 176 / Tuesday, September 12, 2006 / Rules and Regulations 

Regulatory and Policies and Procedures. 

We do not need to do the latter analysis 

where the economic impact of a 

proposal is minimal. This final rule 

amending SFAR 106 has no new costs 

associated with it because there is no 

requirement for use of these devices. 

The regulatory evaluation presented 

when SFAR 106 was first published is 

still valid and applicable, and the 

inclusion of these three devices as 

options for passengers and operators 

does not change the cost or benefits 

assigned in that final rule. 

Regulatory Flexibility Determination 

The Regulatory Flexibility Act of 1980 

(RFA) directs the FAA to fit regulatory 

requirements to the scale of the 

business, organizations, and 

governmental jurisdictions subject to 

the regulation. We are required to 

determine whether a proposed or final 

action will have a ‘‘significant economic 

impact on a substantial number of small 

entities’’ as they are defined in the Act. 

If we find that the action will have a 

significant impact, we must do a 

‘‘regulatory flexibility analysis.’’

This final rule adds three new devices 

to the list of authorized POCs in SFAR 

106. Its economic impact is minimal. 

Therefore, I certify that this action will 

not have a significant economic impact 

on a substantial number of small 

entities. 

Trade Impact Assessment 

The Trade Agreements Act of 1979 

prohibits Federal agencies from 

engaging in any standards or 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 addition, consistent 

with the Administration’s belief in the 

general superiority and desirability of 

free trade, it is the policy of the 

Administration to remove or diminish 

to the extent feasible, barriers to 

international trade, including both 

barriers affecting the export of American 

goods and services to foreign countries 

and barriers affecting the import of 

foreign goods and services into the 

United States. 

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 

costs 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) 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 an 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 inflationadjusted value of $128.1 million in lieu 

of $100 million. 

This final rule does not contain such 

a mandate. The requirements of Title II 

of the Act, therefore, 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. 

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 proposed 

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 (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. 

List of Subjects in 14 CFR Part 121 

Air carriers, Aircraft, Airmen, 

Aviation safety, Charter flights, Safety, 

Transportation, Air taxis. 

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 

■ 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. 

■ 2. Revise Section 2 of SFAR 106 to 

read as follows: 

* * * * * 

Section 2. Definitions—For the 

purposes of this SFAR the following 

definitions apply: Portable Oxygen 

Concentrator: means the AirSep 

LifeStyle, AirSep FreeStyle, Inogen One, 

SeQual Eclipse, or Respironics EverGo 

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. 

* * * * * 

■ 3. Revise Section 3(a) introductory 

text of SFAR 106 to read as follows: 

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, AirSep 

FreeStyle, Inogen One, SeQual Eclipse, 

or Respironics EverGo 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 August 18, 

2006. 

Marion C. Blakey, 

Administrator. 

[FR Doc. 06–7597 Filed 9–11–06; 8:45 am] 

BILLING CODE 4910–13–P 


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