Federal Register / Vol. 77, No. 200 / Tuesday, October 16, 2012 / Rules and Regulations 63217 

addressed. We are issuing this AD to detect 

and correct failure of the main landing gear 

(MLG) to extend and lock, which could 

adversely affect the safe landing of the 

airplane. 

(f) Compliance 

You are responsible for having the actions 

required by this AD performed within the 

compliance times specified, unless the 

actions have already been done. 

(g) Retained Actions for All Airplanes 

Within 2,000 flight hours after September 

19, 2011 (the effective date of AD 2011–17– 

04, Amendment 39–16768 (76 FR 50403, 

August 15, 2011)): Incorporate Bombardier 

Modsum 4–113645, including performing a 

detailed visual inspection for damage or 

cracks of the bumper plate and base fitting 

and replacing any damaged or cracked part, 

in accordance with the Accomplishment 

Instructions of Bombardier Service Bulletin 

84–32–74, Revision A, dated May 17, 2010. 

Do all applicable replacements before further 

flight. 

Note 1 to paragraphs (g) and (h) of this 

AD: Bombardier Service Bulletin 84–32–74, 

Revision A, dated May 17, 2010, includes an 

operational check of the alternate extension 

system of the MLG. If the operational check 

fails, guidance on doing corrective actions 

can be found in the Bombardier Q400 Dash 

8 Aircraft Maintenance Manual. 

(h) Retained Actions for Airplanes Having 

Certain Bumper Plates 

For airplanes on which a bumper plate 

having part number 85424082–101 or 

85424082–103 is installed on which the 

rework specified in Bombardier Repair 

Drawing 8/4–54–553 has been done: Within 

1,000 flight hours after September 19, 2011 

(the effective date of AD 2011–17–04, 

Amendment 39–16768 (76 FR 50403, August 

15, 2011)), reidentify the bumper plate, in 

accordance with paragraph 3.B., step (8) of 

the Accomplishment Instructions of 

Bombardier Service Bulletin 84–32–74, 

Revision A, dated May 17, 2010. 

(i) Retained Credit for Previous Actions 

This paragraph provides credit for the 

modification required by paragraph (h) of 

this AD by incorporation of Bombardier 

Modsum 4–113645 if the modification was 

performed before September 19, 2011 (the 

effective date of AD 2011–17–04, 

Amendment 39–16768 (76 FR 50403, August 

15, 2011)), using Bombardier Service Bulletin 

84–32–74, dated December 23, 2009 (which 

is not incorporated by reference in this AD); 

and provided the modification is done within 

the compliance time specified in paragraph 

(h) of this AD. 

(j) New Requirements of This AD: 

Operational Check for Airplanes on Which 

the Action Required by Paragraph (h) of This 

AD Is Done 

Concurrently with doing the actions 

required by paragraph (h) of this AD, or 

within 30 days after the effective date of this 

AD, whichever occurs later: Perform an 

operational check of the alternate extension 

system of the MLG, in accordance with the 

Accomplishment Instructions of Bombardier 

Service Bulletin 84–32–74, Revision A, dated 

May 17, 2010. If the operational check fails, 

before further flight, repair in accordance 

with a method approved by either the 

Manager, New York Aircraft Certification 

Office (ACO), FAA; or the Transport Canada 

Civil Aviation (TCCA) (or its delegated 

agent). 

Note 2 to paragraph (j) of this AD: If the 

operational check fails, guidance on doing 

the repair can be found in the Bombardier 

Q400 Dash 8 Aircraft Maintenance Manual. 

(k) New Credit for Previous Actions 

This paragraph provides credit for actions 

required by paragraph (g) of this AD, if those 

actions were performed before the effective 

date of this AD, provided the operational 

check specified in paragraph (j) of this AD is 

done within the compliance time specified in 

paragraph (g) of this AD, or within 30 days 

after the effective date of this AD, whichever 

occurs later, using Bombardier Service 

Bulletin 84–32–74, dated December 23, 2009 

(which is not incorporated by reference in 

this AD). 

(l) Other FAA AD Provisions 

The following provisions also apply to this 

AD: 

(1) Alternative Methods of Compliance 

(AMOCs): The Manager, New York ACO, 

ANE–170, FAA, has the authority to approve 

AMOCs for this AD, if requested using the 

procedures found in 14 CFR 39.19. In 

accordance with 14 CFR 39.19, send your 

request to your principal inspector or local 

Flight Standards District Office, as 

appropriate. If sending information directly 

to the New York ACO, send it to ATTN: 

Program Manager, Continuing Operational 

Safety, FAA, New York ACO, 1600 Stewart 

Avenue, Suite 410, Westbury, New York, 

11590; telephone 516–228–7300; fax 516– 

794–5531. Before using any approved AMOC, 

notify your appropriate principal inspector, 

or lacking a principal inspector, the manager 

of the local flight standards district office/ 

certificate holding district office. The AMOC 

approval letter must specifically reference 

this AD. 

(2) Airworthy Product: For any requirement 

in this AD to obtain corrective actions from 

a manufacturer or other source, use these 

actions if they are FAA-approved. Corrective 

actions are considered FAA-approved if they 

are approved by the State of Design Authority 

(or their delegated agent). You are required 

to assure the product is airworthy before it 

is returned to service. 

(m) Related Information 

(1) Refer to MCAI Canadian Airworthiness 

Directive CF–2010–23, dated July 21, 2010; 

and Bombardier Service Bulletin 84–32–74, 

Revision A, dated May 17, 2010; for related 

information. 

(2) For service information identified in 

this AD, contact Bombardier, Inc., Q-Series 

Technical Help Desk, 123 Garratt Boulevard, 

Toronto, Ontario M3K 1Y5, Canada; 

telephone 416–375–4000; fax 416–375–4539; 

email thd.qseries@aero.bombardier.com; 

Internet http://www.bombardier.com. 

(n) Material Incorporated by Reference 

(1) The Director of the Federal Register 

approved the incorporation by reference 

(IBR) of the service information listed in this 

paragraph under 5 U.S.C. 552(a) and 1 CFR 

part 51. 

(2) You must use this service information 

as applicable to do the actions required by 

this AD, unless the AD specifies otherwise. 

(3) The following service information was 

approved for IBR on September 19, 2011 (76 

FR 50403, August 15, 2011). 

(i) Bombardier Service Bulletin 84–32–74, 

Revision A, dated May 17, 2010. 

(ii) Reserved. 

(4) For service information identified in 

this AD, contact Bombardier, Inc., Q-Series 

Technical Help Desk, 123 Garratt Boulevard, 

Toronto, Ontario M3K 1Y5, Canada; 

telephone 416–375–4000; fax 416–375–4539; 

email thd.qseries@aero.bombardier.com; 

Internet http://www.bombardier.com. 

(5) You may review copies of the service 

information at the FAA, Transport Airplane 

Directorate, 1601 Lind Avenue SW., Renton, 

WA. For information on the availability of 

this material at the FAA, call 425–227–1221. 

(6) You may view this service information 

that is incorporated by reference at the 

National Archives and Records 

Administration (NARA). For information on 

the availability of this material at NARA, call 

202–741–6030, or go to: http:// 

www.archives.gov/federal-register/cfr/ibrlocations.html. 

Issued in Renton, Washington, on October 

4, 2012. 

Dionne Palermo, 

Acting Manager, Transport Airplane 

Directorate, Aircraft Certification Service. 

[FR Doc. 2012–25109 Filed 10–15–12; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF TRANSPORTATION 

Federal Aviation Administration 

14 CFR Part 121 

[Docket No. FAA–2012–0928; Amdt. No. 

121–361] 

RIN 2120–AK18 

Use of Additional Portable Oxygen 

Concentrators on Board Aircraft 

AGENCY: Federal Aviation 

Administration (FAA), DOT. 

ACTION: Final rule. 

SUMMARY: This action amends the FAA’s 

rules for permitting limited use of 

portable oxygen concentrator systems 

on board aircraft, to allow for the use of 

additional portable oxygen concentrator 

(POC) devices on board aircraft, 

provided certain conditions in the SFAR 

are met. This action is necessary to 

allow all POC devices deemed 

acceptable by the FAA for use in air 

commerce to be available to the 


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63218 Federal Register / Vol. 77, No. 200 / Tuesday, October 16, 2012 / Rules and Regulations 

traveling public in need of oxygen 

therapy. Passengers will be able to carry 

these devices on board the aircraft and 

use them with the approval of the 

aircraft operator. 

DATES: Effective October 31, 2012. 

FOR FURTHER INFORMATION CONTACT: For 

technical questions concerning this 

action, contact DK Deaderick, Air 

Transportation Division, AFS–200, 

Flight Standards Service, Federal 

Aviation Administration, 800 

Independence Avenue SW., 

Washington, DC 20591; telephone 202– 

167–8166; email DK.Deaderick@faa.gov. 

SUPPLEMENTARY INFORMATION: 

Authority for This Rulemaking 

The FAA is authorized to issue this 

final rule pursuant to 49 U.S.C. 44701. 

Under that section, the FAA is 

authorized to establish regulations and 

minimum standards for other practices, 

methods, and procedures the 

Administrator finds necessary for air 

commerce and national security. 

Background 

On July 12, 2005, the FAA published 

Special Federal Aviation Regulation 106 

(SFAR 106) entitled, ‘‘Use of Certain 

Portable Oxygen Concentrator Devices 

Onboard Aircraft’’ (70 FR 40156). SFAR 

106 is the result of a notice the FAA 

published in July 2004 (69 FR 42324) to 

address the needs of passengers who 

must travel with medical oxygen. Before 

publication of SFAR 106, passengers in 

need of medical oxygen during air 

transportation faced many obstacles 

when requesting service. Many aircraft 

operators did not provide medical 

oxygen service aboard flights, and those 

that did often provided service at a price 

that travelers could not afford. 

Coordinating service between operators 

and suppliers at airports was also 

difficult, and passengers frequently 

chose not to fly because of these 

difficulties. 

Medical oxygen technologies 

approved by the Food and Drug 

Administration (FDA) reduce the risks 

typically associated with compressed 

oxygen and provide a safe alternative for 

passengers who need oxygen therapy. 

Numerous manufacturers have 

developed small portable oxygen 

concentrators (POC) that work by 

separating oxygen from nitrogen and 

other gases contained in ambient air and 

dispensing it in concentrated form to 

the user with an oxygen concentration 

of about 90%. The POCs operate using 

either rechargeable batteries or, if the 

aircraft operator obtains approval from 

the FAA, aircraft electrical power. 

In addition, the Pipeline and 

Hazardous Materials Safety 

Administration (PHMSA) has 

determined that the POCs covered by 

this amendment are not hazardous 

material. Thus, they do not require the 

same level of special handling as 

compressed oxygen, and are safe for use 

on board aircraft, provided certain 

conditions for their use are met. 

SFAR 106 permits passengers to carry 

on and use certain POCs on board 

aircraft if the aircraft operator ensures 

that the conditions specified in the 

SFAR for their use are met. The devices 

initially determined acceptable for use 

in SFAR 106, published July 12, 2005, 

were AirSep Corporation’s LifeStyle and 

Inogen, Inc.’s Inogen One POCs. SFAR 

106 has been amended several times to 

allow passengers to use additional 

devices. This final rule adds additional 

POC devices, including AirSep 

Corporation’s Focus, AirSep FreeStyle 

5, Inogen One G3, Inova Labs, Inc.’s 

LifeChoice Activox, Phillips Respironics 

Simply Go, Precision Medical Inc.’s 

EasyPulse and SeQual Technologies, 

Inc.’s SAROS that may be carried on 

and used by a passenger on board an 

aircraft. 

In addition, on January 27, 2012 (77 

FR 4219), the FAA published a 

Technical Amendment to update the 

names of two approved POC 

manufacturers due to business changes. 

The LifeChoice POC is currently being 

manufactured by Inova Labs, Inc. and 

the RS–00400 POC is currently being 

manufactured by Oxus, Inc. In the 

technical amendment, the FAA 

inadvertently removed the previous 

manufacturer’s names from the list of 

approved POCs in SFAR 106. People 

still have POCs marked with those 

manufacturer’s names. In this final rule, 

the FAA will add those previous 

manufacturer’s names (International 

Biophysics Corporation’s LifeChoice 

and Delphi Medical Systems’ RS–00400) 

back to the list of approved POCs in 

SFAR 106. 

Aircraft operators can meet certain 

conditions and allow passengers to 

carry on and use one of the POC devices 

covered in SFAR 106. SFAR 106 is an 

enabling rule, which means that no 

aircraft operator is required to allow 

passengers to operate these POC devices 

on board its aircraft, but it may allow 

them to be operated on board. If one of 

these devices is allowed by the aircraft 

operator to be operated on board, the 

conditions in the SFAR must be met. 

When SFAR 106 was published, the 

FAA committed to establishing a single 

performance standard for all POCs so 

the regulations wouldn’t apply to 

specific manufacturers and models of 

device. Whenever possible, the FAA 

tries to regulate by creating 

performance-based standards rather 

than approving by manufacturer. In the 

case of SFAR 106, the most efficient 

way to serve both the passenger and the 

aircraft operator was to allow the use of 

the devices determined to be acceptable 

by the FAA in SFAR 106 in a special, 

temporary regulation. As the FAA stated 

in the preamble discussion of the final 

rule that established SFAR 106, ‘‘while 

we are committed to developing a 

performance-based standard for all 

future POC devices, we do not want to 

prematurely develop standards that 

have the effect of stifling new 

technology of which we are unaware.’’ 

The FAA developed and published 

SFAR 106 so passengers who otherwise 

could not fly could do so with an 

affordable alternative to what existed 

before SFAR 106 was published. 

The FAA continues to pursue the 

performance-based standard for all 

POCs. This process is time-consuming, 

and the FAA intends to publish a notice 

in the Federal Register and offer the 

public a chance to comment on the 

proposal when it is complete. In the 

meantime, manufacturers continue to 

create new and better POCs, and 

manufacturers have requested that their 

product also be included as an 

acceptable POC in SFAR 106. Precision 

Medical, Inc., Inogen, Inc. and AirSep 

Corporation have formally submitted 

petitions for exemption to the FAA that 

would allow their POCs to be used on 

aircraft. In addition, SeQual 

Technologies, Inc., Inova Labs, Inc., and 

Phillips Respironics have submitted 

requests for approval and addition to 

SFAR 106, with all required 

documentation for their POCs, to the 

Department of Transportation’s Docket 

Management System. 

Additionally, as stated in Section 2 of 

SFAR 106, no covered device may 

contain hazardous materials as 

determined by PHMSA (written 

documentation necessary), and each 

device must also be regulated by the 

FDA. All manufacturers have included 

technical specifications for their devices 

in each request for approval, as well as 

the required documentation from 

PHMSA and the FDA. 

The Rule 

This amendment to SFAR 106 will 

include the AirSep Focus, AirSep 

FreeStyle 5, Inogen One G3, Inova Labs 

LifeChoice Activox, Respironics Simply 

Go, Precision Medical EasyPulse and 

SeQual SAROS devices in the list of 

POC devices authorized for use in air 

commerce. The FAA has reviewed these 

devices and accepted the 


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documentation provided by the 

manufacturers. That documentation 

includes letters provided to the 

manufacturer by PHMSA and the FDA 

affirming the status of the device as it 

applies to the requirements stated in 

SFAR 106. After reviewing the 

applicable FDA safety standards and the 

PHMSA findings, the device was 

determined by the FAA to be acceptable 

for use in air commerce. 

Additionally, in the January 27, 2012 

technical amendment to SFAR 106, 

while updating manufacturer’s names 

due to business changes, the FAA 

inadvertently removed the previous 

manufacturer’s names from the list of 

approved POCs. Even though these 

POCs are manufactured under new 

manufacturer’s names, people still have 

POCs marked with the previous 

manufacturer’s names. In this final rule, 

the FAA will add those previous 

manufacturer’s names (International 

Biophysics Corporation’s LifeChoice 

and Delphi Medical Systems’ RS–00400) 

back to the list of approved POCs in 

SFAR 106. 

Waiver of Notice of Proposed 

Rulemaking and Delay in Effective Date 

Section 553 of the Administrative 

Procedure Act, 5 U.S.C 553(b)(3)(B), 

provides that, when an agency for good 

cause finds that notice and public 

procedure are impracticable, 

unnecessary, or contrary to the public 

interest, the agency may issue a rule 

without providing notice and an 

opportunity for public comment. We 

have determined that there is good 

cause for making the rule final without 

prior proposal and opportunity for 

comment because the issues related to 

the use of POC devices on board aircraft 

have already been discussed as part of 

an earlier rulemaking. More specifically, 

on July 14, 2004, the FAA issued a 

notice of proposed rulemaking on the 

use of portable oxygen concentrator 

devices on board aircraft (69 FR 42324). 

Then, on July 12, 2005, after reviewing 

public comments received, the FAA 

published Special Federal Aviation 

Regulation 106 (SFAR 106) entitled, 

‘‘Use of Certain Portable Oxygen 

Concentrator Devices on Board 

Aircraft.’’ (70 FR 40156) Therefore, it is 

unnecessary and contrary to the public 

interest to publish a notice requesting 

comments on this amendment. 

Moreover, pursuant to 5 

U.S.C.553(d)(3), we find that good cause 

exists for making this rule effective in 

less than 30 days. This rule is being 

made effective 15 calendar days after its 

publication in the Federal Register to 

prevent unnecessary delay in 

acceptance of these devices as 

authorized for use on board aircraft by 

airlines while still providing airlines 

adequate notice and time to ensure the 

devices can be used safely on board 

aircraft. We believe, based on 

information the Department has 

received from airlines, that fifteen 

calendar days is sufficient amount of 

time for an airline to ensure/confirm 

that an FAA-approved POC does not 

cause interference with avionics system 

on that carrier’s aircraft and convey this 

information to the appropriate airline 

personnel in order to accept these 

devices on board aircraft for use by 

passengers who need oxygen therapy for 

air travel. As such, the FAA believes 

that good cause exists for making this 

rule effective 15 calendar days after its 

publication in the Federal Register. 

Regulatory Notices and Analyses 

Regulatory Evaluation 

Changes to Federal regulations must 

undergo several economic analyses. 

First, Executive Order 12866 and 

Executive Order 13563 directs that each 

Federal agency shall propose or adopt a 

regulation only upon a reasoned 

determination that the benefits of the 

intended regulation justify its costs. 

Second, the Regulatory Flexibility Act 

of 1980 (Pub. L. 96–354) requires 

agencies to analyze the economic 

impact of regulatory changes on small 

entities. Third, the Trade Agreements 

Act (Pub. L. 96–39) prohibits agencies 

from setting standards that create 

unnecessary obstacles to the foreign 

commerce of the United States. In 

developing U.S. standards, this Trade 

Act requires agencies to consider 

international standards and, where 

appropriate, that they be the basis of 

U.S. standards. Fourth, the Unfunded 

Mandates Reform Act of 1995 (Pub. L. 

104–4) requires agencies to prepare a 

written assessment of the costs, benefits, 

and other effects of proposed or final 

rules that include a Federal mandate 

likely to result in the expenditure by 

State, local, or tribal governments, in the 

aggregate, or by the private sector, of 

$100 million or more annually (adjusted 

for inflation with base year of 1995). 

This portion of the preamble 

summarizes the FAA’s analysis of the 

economic impacts of this final rule. 

Department of Transportation Order 

DOT 2100.5 prescribes policies and 

procedures for simplification, analysis, 

and review of regulations. If the 

expected cost impact is so minimal that 

a proposed or final rule does not 

warrant a full evaluation, this order 

permits that a statement to that effect 

and the basis for it be included in the 

preamble if a full regulatory evaluation 

of the cost and benefits is not prepared. 

Such a determination has been made for 

this final rule. The reasoning for this 

determination follows: 

This action amends SFAR 106 to 

allow for the use of additional POC 

devices on board aircraft, provided 

certain conditions in the SFAR are met. 

This action is necessary to allow 

additional POC devices deemed 

acceptable by the FAA to be available to 

the traveling public in need of oxygen 

therapy, for use in air commerce. When 

this rule becomes effective, there will 

many different POC devices the FAA 

finds acceptable for use on board 

aircraft, and passengers will be able to 

carry these devices on board the aircraft 

and use them with the approval of the 

aircraft operator. As the rule increases 

the number of acceptable POC devices 

on board aircraft, the rule does not 

increase costs and provides additional 

benefits. The FAA has, therefore, 

determined that this final rule is not a 

‘‘significant regulatory action’’ as 

defined in section 3(f) of Executive 

Order 12866, and is not ‘‘significant’’ as 

defined in DOT’s Regulatory Policies 

and Procedures. 

Regulatory Flexibility Determination 

The Regulatory Flexibility Act of 1980 

(Pub. L. 96–354) (RFA) establishes ‘‘as a 

principle of regulatory issuance that 

agencies shall endeavor, consistent with 

the objectives of the rule and of 

applicable statutes, to fit regulatory and 

informational requirements to the scale 

of the businesses, organizations, and 

governmental jurisdictions subject to 

regulation. To achieve this principle, 

agencies are required to ‘‘solicit and 

consider flexible regulatory proposals 

and to explain the rationale for their 

actions to assure that such proposals are 

given serious consideration.’’ The RFA 

covers a wide-range of small entities, 

including small businesses, not-forprofit organizations, and small 

governmental jurisdictions. 

Agencies must perform a review to 

determine whether a rule will have a 

significant economic impact on a 

substantial number of small entities. If 

the agency determines that it will, the 

agency must prepare a regulatory 

flexibility analysis as described in the 

RFA. 

However, if an agency determines that 

a rule is not expected to have a 

significant economic impact on a 

substantial number of small entities, 

section 605(b) of the RFA provides that 

the head of the agency may so certify 

and a regulatory flexibility analysis is 

not required. The certification must 

include a statement providing the 


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63220 Federal Register / Vol. 77, No. 200 / Tuesday, October 16, 2012 / Rules and Regulations 

factual basis for this determination, and 

the reasoning should be clear. 

This final rule adds additional POC 

devices to the list of authorized POC 

devices in SFAR 106. This economic 

impact is minimal. Therefore, as the 

Acting FAA Administrator, I certify that 

this action will not have a significant 

economic impact on a substantial 

number of small entities. 

Unfunded Mandates Assessment 

Title II of the Unfunded Mandates 

Reform Act of 1995 (Pub. L. 104–4) 

requires each Federal agency to prepare 

a written statement assessing the effects 

of any Federal mandate in a proposed or 

final agency rule that may result in an 

expenditure of $100 million or more (in 

1995 dollars) in any one year by State, 

local, and tribal governments, in the 

aggregate, or by the private sector; such 

a mandate is deemed to be a ‘‘significant 

regulatory action.’’ The FAA currently 

uses an inflation-adjusted value of 

$143.1 million in lieu of $100 million. 

This final rule does not contain such a 

mandate; therefore, the requirements of 

Title II of the Act do not apply. 

Paperwork Reduction 

The Paperwork Reduction Act of 1995 

(44 U.S.C. 3507(d)) requires that the 

FAA consider the impact of paperwork 

and other information collection 

burdens imposed on the public. 

According to the 1995 amendments to 

the Paperwork Reduction Act (5 CFR 

1320.8(b)(2)(vi)), an agency may not 

collect or sponsor the collection of 

information, nor may it impose an 

information collection requirement 

unless it displays a currently valid 

Office of Management and Budget 

(OMB) control number. 

Information collection requirements 

associated with this final rule have been 

approved previously by the Office of 

Management and Budget (OMB) under 

the provisions of the Paperwork 

Reduction Act of 1995 (44 U.S.C. 

3507(d)) and have been assigned OMB 

Control Number 2120–0702. This final 

rule requires that if a passenger carries 

a POC device on board the aircraft with 

the intent to use it during the flight, he 

or she must inform the pilot in 

command of that flight. Additionally, 

the passenger who plans to use the 

device must provide a written statement 

signed by a licensed physician that 

verifies the passenger’s ability to operate 

the device, respond to any alarms, the 

extent to which the passenger must use 

the POC (all or a portion of the flight), 

and prescribes the maximum oxygen 

flow rate. The Paperwork Reduction Act 

paragraph in the final rule that 

established SFAR 106 still applies to 

this amendment. The availability of a 

new POC device will likely increase the 

availability and options for a passenger 

in need of oxygen therapy, but the 

paperwork burden discussed in the 

original final rule is unchanged. 

Therefore, the OMB Control Number 

associated with this collection remains 

2120–0702. 

An agency may not conduct or 

sponsor, and a person is not required to 

respond to, a collection of information 

unless it displays a currently valid OMB 

control number. 

International Compatibility 

In keeping with U.S. obligations 

under the Convention on International 

Civil Aviation, it is FAA policy to 

conform to International Civil Aviation 

Organization (ICAO) Standards and 

Recommended Practices to the 

maximum extent practicable. The FAA 

has determined that there are no ICAO 

Standards and Recommended Practices 

that correspond to these regulations. 

International Trade Impact Assessment 

The Trade Agreements Act of 1979 

(Pub. L. 96–39), as amended by the 

Uruguay Round Agreements Act (Pub. 

L. 103–465), prohibits Federal agencies 

from establishing standards or engaging 

in related activities that create 

unnecessary obstacles to the foreign 

commerce of the United States. 

Pursuant to these Acts, the 

establishment of standards is not 

considered an unnecessary obstacle to 

the foreign commerce of the United 

States, so long as the standard has a 

legitimate domestic objective, such the 

protection of safety, and does not 

operate in a manner that excludes 

imports that meet this objective. The 

statute also requires consideration of 

international standards and, where 

appropriate, that they be the basis for 

U.S. standards. The FAA has assessed 

the potential effect of this final] rule and 

determined that it will have only a 

domestic impact and therefore will not 

create unnecessary obstacles to the 

foreign commerce of the United States. 

Environmental Analysis 

FAA Order 1050.1E identifies FAA 

actions that are categorically excluded 

from preparation of an environmental 

assessment or environmental impact 

statement under the National 

Environmental Policy Act in the 

absence of extraordinary circumstances. 

The FAA has determined this 

rulemaking action qualifies for the 

categorical exclusion identified in 

paragraph 312f and involves no 

extraordinary circumstances. 

Executive Order Determinations 

Executive Order 13132, Federalism 

The FAA has analyzed this 

immediately adopted final rule under 

the principles and criteria of Executive 

Order 13132, Federalism. The agency 

determined that this action will not 

have a substantial direct effect on the 

States, or the relationship between the 

Federal Government and the States, or 

on the distribution of power and 

responsibilities among the various 

levels of government, and, therefore, 

does not have Federalism implications. 

Executive Order 13211, Regulations 

That Significantly Affect Energy Supply, 

Distribution, or Use 

The FAA analyzed this immediately 

adopted final rule under Executive 

Order 13211, Actions Concerning 

Regulations that Significantly Affect 

Energy Supply, Distribution, or Use 

(May 18, 2001). The agency has 

determined that it is not a ‘‘significant 

energy action’’ under the executive 

order and it is not likely to have a 

significant adverse effect on the supply, 

distribution, or use of energy. 

How To Obtain Additional Information 

Rulemaking Documents 

An electronic copy of a rulemaking 

document my be obtained by using the 

Internet— 

1. Search the Federal eRulemaking 

Portal (http://www.regulations.gov); 

2. Visit the FAA’s Regulations and 

Policies Web page at http:// 

www.faa.gov/regulations_policies/or 

3. Access the Government Printing 

Office’s Web page at http:// 

www.gpo.gov/fdsys/. 

Copies may also be obtained by 

sending a request (identified by notice, 

amendment, or docket number of this 

rulemaking) to the Federal Aviation 

Administration, Office of Rulemaking, 

ARM–1, 800 Independence Avenue 

SW., Washington, DC 20591, or by 

calling (202) 267–9680. 

Small Business Regulatory Enforcement 

Fairness Act 

The Small Business Regulatory 

Enforcement Fairness Act (SBREFA) of 

1996 requires FAA to comply with 

small entity requests for information or 

advice about compliance with statutes 

and regulations within its jurisdiction. 

A small entity with questions regarding 

this document, may contact its local 

FAA official, or the person listed under 

the FOR FURTHER INFORMATION CONTACT

heading at the beginning of the 

preamble. To find out more about 

SBREFA on the Internet, visit http:// 


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Federal Register / Vol. 77, No. 200 / Tuesday, October 16, 2012 / Rules and Regulations 63221 

www.faa.gov/regulations_policies/ 

rulemaking/sbre_act/. 

List of Subjects in 14 CFR Part 121 

Air carriers, Aircraft, Airmen, 

Reporting and recordkeeping 

requirements. 

The Amendment 

In consideration of the foregoing, the 

Federal Aviation Administration 

amends SFAR No. 106 to Chapter I of 

title 14, Code of Federal Regulations as 

follows: 

PART 121—OPERATING 

REQUIREMENTS: DOMESTIC, FLAG, 

AND SUPPLEMENTAL OPERATIONS 

■ 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. Amend SFAR 106 by revising 

sections 2 and 3(a) introductory text to 

read as follows: 

Special Federal Aviation Regulation 

106—Rules for Use of Portable Oxygen 

Concentrator Systems on Board 

Aircraft 

* * * * * 

Section 2. Definitions—For the 

purposes of this SFAR the following 

definitions apply: Portable Oxygen 

Concentrator: means the AirSep 

FreeStyle, AirSep LifeStyle, AirSep 

Focus, AirSep FreeStyle 5, Delphi RS– 

00400, DeVilbiss Healthcare iGo, Inogen 

One, Inogen One G2, Inogen One G3, 

Inova Labs LifeChoice, Inova Labs 

LifeChoice Activox, International 

Biophysics LifeChoice, Invacare XPO2, 

Invacare Solo2, Oxlife Independence 

Oxygen Concentrator, Oxus RS–00400, 

Precision Medical EasyPulse, 

Respironics EverGo, Respironics 

SimplyGo, SeQual Eclipse and SeQual 

SAROS Portable Oxygen Concentrator 

medical device units as long as those 

medical device units: (1) Do not contain 

hazardous materials as determined by 

the Pipeline and Hazardous Materials 

Safety Administration; (2) are also 

regulated by the Food and Drug 

Administration; and (3) assist a user of 

medical oxygen under a doctor’s care. 

These units perform by separating 

oxygen from nitrogen and other gases 

contained in ambient air and dispensing 

it in concentrated form to the user. 

Section 3. Operating Requirements— 

(a) No person may use and no aircraft 

operator may allow the use of any 

portable oxygen concentrator device, 

except the AirSep FreeStyle, AirSep 

LifeStyle, AirSep Focus, AirSep 

FreeStyle 5, Delphi RS–00400, DeVilbiss 

Healthcare iGo, Inogen One, Inogen One 

G2, Inogen One G3, Inova Labs 

LifeChoice, Inova Labs LifeChoice 

Activox, International Biophysics 

LifeChoice, Invacare XPO2, Invacare 

Solo2, Oxlife Independence Oxygen 

Concentrator, Oxus RS–00400, Precision 

Medical EasyPulse, Respironics EverGo, 

Respironics SimplyGo, SeQual Eclipse 

and SeQual SAROS Portable Oxygen 

Concentrator units. These units may be 

carried on and used by a passenger on 

board an aircraft provided the aircraft 

operator ensures that the following 

conditions are satisfied: 

* * * * * 

Issued in Washington, DC, on October 2, 

2012. 

Michael P. Huerta, 

Acting Administrator. 

[FR Doc. 2012–25412 Filed 10–15–12; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF TRANSPORTATION 

Federal Aviation Administration 

14 CFR Part 440 

Waiver of Requirement To Enter Into a 

Reciprocal Waiver of Claims 

Agreement With All Customers 

AGENCY: Federal Aviation 

Administration (FAA), DOT. 

ACTION: Notice of waiver. 

SUMMARY: This notice concerns a 

petition for waiver submitted to the 

FAA by Space Exploration Technologies 

Corp. (SpaceX) to waive in part the 

requirement that a launch operator enter 

into a reciprocal waiver of claims with 

each customer. The FAA grants the 

petition. 

DATES: October 16, 2012. 

FOR FURTHER INFORMATION CONTACT: For 

technical questions concerning this 

waiver, contact Charles P. Brinkman, 

Licensing Program Lead, Commercial 

Space Transportation—Licensing and 

Evaluation Division, 800 Independence 

Avenue SW., Washington, DC 20591; 

telephone: (202) 267–7715; email: 

Phil.Brinkman@faa.gov. For legal 

questions concerning this waiver, 

contact Laura Montgomery, Senior 

Attorney for Commercial Space 

Transportation, AGC–200, Office of the 

Chief Counsel, International, Legislation 

and Regulations Division, Federal 

Aviation Administration, 800 

Independence Avenue SW., 

Washington, DC 20591; telephone (202) 

267–3150; email: 

Laura.Montgomery@faa.gov. 

SUPPLEMENTARY INFORMATION: 

Background 

On September 20, 2012, SpaceX 

submitted a petition to the Federal 

Aviation Administration’s (FAA’s) 

Office of Commercial Space 

Transportation (AST) requesting a 

waiver under its launch license, for 

flight of a Falcon 9 launch vehicle 

carrying a Dragon reentry vehicle, and 

the related reentry license, for reentry of 

the Dragon. SpaceX requested a partial 

waiver of 14 CFR 440.17, which requires 

a licensee to enter into a reciprocal 

waiver of claims (a ‘‘cross-waiver’’) with 

each of its customers. 

The FAA licenses the launch of a 

launch vehicle and reentry of a reentry 

vehicle under authority granted to the 

Secretary of Transportation by the 

Commercial Space Launch Act of 1984, 

as amended and re-codified by 51 U.S.C. 

Subtitle V, chapter 509 (Chapter 509), 

and delegated to the FAA Administrator 

and the Associate Administrator for 

Commercial Space Transportation, who 

exercises licensing authority under 

Chapter 509. 

The petition for waiver applies to 

SpaceX’s October launch of a Falcon 9 

launch vehicle and Dragon reentry 

vehicle to the International Space 

Station (ISS) and return of the Dragon 

from the ISS to Earth. The Dragon 

spacecraft will carry cargo for NASA to 

resupply the ISS and return with cargo 

from the ISS. The Falcon 9 will also 

carry a commercial satellite for 

ORBCOMM, Inc. as a secondary 

payload, and has signed cross-waivers 

covering that payload. The cross-waiver 

among SpaceX, ORBCOMM and the 

FAA is amended to provide that 

ORBCOMM waives claims against any 

other customer as defined by 14 CFR 

440.3. The petition for partial waiver of 

the requirement that the licensee 

implement a cross-waiver with each 

customer applies to all launches and 

reentries under SpaceX’s current 

licenses with respect only to the 

customers that are the subject of this 

waiver. 

In addition to the ISS supplies and 

ORBCOMM satellite, SpaceX will carry 

other payloads whose transport NASA 

has arranged. These consist of a 

NanoRacks, LLC, (NanoRacks) locker 

insert and student experiments created 

under NASA’s Student Spaceflight 

Experiments Program (SSEP). NASA 

describes SSEP as a national science, 

technology, engineering and 


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