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.

The Amendment

In consideration of the foregoing, the Federal Aviation Administration amends chapter 1 of title 14, Code of Federal Regulations as follows:

1. The authority citation for part 121 continues to read as follows:

( printed page 4220) Authority: 49 U.S.C. 106(g), 40113, 40119, 41706, 44101, 44701-44702, 44705, 44709-44711, 44713, 44716-44717, 44722, 46105.

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: