Document ID: FAA-2011-1343-0001
Agency: faa
Document Type: Rule
Title: FAA-Approved Portable Oxygen Concentrators: Technical Amendment
Posted Date: 2012-01-27T05:00Z

[Federal Register Volume 77, Number 18 (Friday, January 27, 2012)]
[Rules and Regulations]
[Pages 4219-4220]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-1830]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 121

[Docket No. FAA-2011-1343; Amdt. No. 121-358]

FAA-Approved Portable Oxygen Concentrators; Technical Amendment

AGENCY: Federal Aviation Administration, DOT.

ACTION: Final rule; technical amendment.

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SUMMARY: The FAA is amending regulations relating to operating rules 
for FAA approved portable oxygen concentrators (POC) onboard aircraft. 
This document updates the names of two manufacturers of approved POCs 
listed in the Special Federal Aviation Regulation (SFAR).

DATES: Effective January 27, 2012.

FOR FURTHER INFORMATION CONTACT: For technical questions concerning 
this action, contact DK Deaderick, Air Transportation Division, AFS-
200, Federal Aviation Administration, 800 Independence Avenue SW., 
Washington, DC 20591; telephone: (202) 267-7480; email: 
DK.Deaderick@faa.gov. For legal questions concerning this action, 
contact Alex Zektser, AGC-220, Office of Chief Counsel, Regulations 
Division, Federal Aviation Administration, 800 Independence Avenue SW., 
Washington, DC 20591; telephone (202) 267-3073; email: 
Alex.Zektser@faa.gov.

SUPPLEMENTARY INFORMATION: 

Background

    On July 12, 2005, the FAA published SFAR 106, ``Use of Certain 
Portable Oxygen Concentrator Devices Onboard Aircraft'' (70 FR 40156). 
SFAR 106 permits passengers to carry on and use certain small portable 
oxygen concentrators (POCs) on board aircraft if the operator ensures 
compliance with conditions specified in the SFAR. Some of the devices 
determined acceptable for use in SFAR 106 are Delphi Medical Systems' 
RS-00400 (added to the SFAR in 74 FR 2351) and International Biophysics 
Corporation's LifeChoice (added to the SFAR in 75 FR 739).
    As a result of business changes that took place after SFAR 106 was 
published, the LifeChoice POC is now manufactured by Inova Labs, Inc. 
and not by the International Biophysics Corporation. Similarly, the RS-
00400 POC is now manufactured by Oxus, Inc. and not by Delphi Medical 
Systems.
    The two companies currently manufacturing these POCs have 
petitioned the FAA to amend SFAR 106, Section 2 and section 3(a), of 
Title 14, Code of Federal Regulations (14 CFR). This amendment would 
update section 2 and section 3(a) of SFAR 106 with the names of the 
current manufacturers of the LifeChoice and RS-00400 POCs.

Technical Amendment

    LifeChoice and RS-00400 are still the same products that were 
originally approved in SFAR 106--only the names of their manufacturers 
have changed. As such, this technical amendment makes two revisions to 
the final rule. First, the language in SFAR 106 section 2 and section 
3(a) is revised to refer to LifeChoice as being manufactured by Inova 
Labs. Second, the reference to the RS-00400 POC is revised to refer to 
this device as being manufactured by Oxus, Inc.
    Because the changes in this technical amendment result in no 
substantive change, we find good cause exists under 5 U.S.C. 553(d)(3) 
to make the amendment effective in less than 30 days.

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 chapter 1 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:

[[Page 4220]]

    Authority: 49 U.S.C. 106(g), 40113, 40119, 41706, 44101, 44701-
44702, 44705, 44709-44711, 44713, 44716-44717, 44722, 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, DeVilbiss Healthcare iGo, Inogen One, 
Inogen One G2, Invacare XPO2, Invacare Solo2, Inova Labs LifeChoice, 
Oxlife Independence Oxygen Concentrator, Oxus, Inc. RS-00400, 
Respironics EverGo, and SeQual Eclipse Portable Oxygen Concentrator 
medical device units as long as those medical device units: (1) Do not 
contain hazardous materials as determined by the Pipeline and Hazardous 
Materials Safety Administration; (2) are also regulated by the Food and 
Drug Administration; and (3) assist a user of medical oxygen under a 
doctor's care. These units perform by separating oxygen from nitrogen 
and other gases contained in ambient air and dispensing it in 
concentrated form to the user.
    (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, DeVilbiss Healthcare iGo, Inogen One, Inogen One G2, 
Invacare XPO2, Invacare Solo2, Inova Labs LifeChoice, Oxlife 
Independence Oxygen Concentrator, Oxus, Inc. RS-00400, Respironics 
EverGo, and SeQual Eclipse Portable Oxygen Concentrator units. These 
units may be carried on and used by a passenger on board an aircraft 
provided the aircraft operator ensures that the following conditions 
are satisfied:
* * * * *

    Issued in Washington, DC, on January 20, 2012.
Pamela Hamilton-Powell,
Director, Office of Rulemaking.
[FR Doc. 2012-1830 Filed 1-26-12; 8:45 am]
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