Vol. 81 Tuesday, 

No. 100 May 24, 2016 

Part V 

Department of Transportation 

Federal Aviation Administration 

14 CFR Parts 1, 11, 121, et al. 

Acceptance Criteria for Portable Oxygen Concentrators Used On Board 

Aircraft; Final Rule 

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33098 Federal Register / Vol. 81, No. 100 / Tuesday, May 24, 2016 / Rules and Regulations 

1POCs identified in the SFAR are referred to in 

this preamble as SFAR-approved POCs or SFARapproved devices. 

DEPARTMENT OF TRANSPORTATION 

Federal Aviation Administration 

14 CFR Parts 1, 11, 121, 125, and 135 

Office of the Secretary 

14 CFR Part 382 

[Docket No.: FAA–2014–0554; Amdt. Nos. 

1–69, 11–59, 121–374, 125–65, and 135–133] 

RIN 2120–AK32 

Acceptance Criteria for Portable 

Oxygen Concentrators Used On Board 

Aircraft 

AGENCY: Federal Aviation 

Administration (FAA) and Office of the 

Secretary (OST), Department of 

Transportation (DOT). 

ACTION: Final rule. 

SUMMARY: This final rule replaces the 

existing process by which the Federal 

Aviation Administration (Agency or 

FAA) approves portable oxygen 

concentrators (POC) for use on board 

aircraft in air carrier operations, 

commercial operations, and certain 

other operations using large aircraft. The 

FAA currently assesses each POC make 

and model on a case-by-case basis and 

if the FAA determines that a particular 

POC is safe for use on board an aircraft, 

the FAA conducts rulemaking to 

identify the specific POC model in an 

FAA regulation. This final rule replaces 

the current process and allows 

passengers to use a POC on board an 

aircraft if the POC satisfies certain 

acceptance criteria and bears a label 

indicating conformance with the 

acceptance criteria. The labeling 

requirement only affects POCs intended 

for use on board aircraft that were not 

previously approved for use on aircraft 

by the FAA. Additionally, this 

rulemaking will eliminate redundant 

operational requirements and 

paperwork requirements related to the 

physician’s statement. As a result, this 

rulemaking will reduce burdens for POC 

manufacturers, passengers who use 

POCs while traveling, and affected 

aircraft operators. This final rule also 

makes conforming amendments to the 

Department of Transportation’s 

(Department or DOT) rule implementing 

the Air Carrier Access Act (ACAA) to 

require carriers to accept all POC 

models that meet FAA acceptance 

criteria as detailed in this rule. 

DATES: The amendments to 14 CFR 1.1, 

1.2, 121.574, 125.219, and 135.91 are 

effective June 23, 2016. The 

amendments to 14 CFR 11.201, 121.306, 

125.204, 135.144, 382,27, and 382.133, 

and the removal of Special Federal 

Aviation Regulation No. 106 are 

effective August 22, 2016. 

ADDRESSES: For information on where to 

obtain copies of rulemaking documents 

and other information related to this 

final rule, see ‘‘How to Obtain 

Additional Information’’ in the 

SUPPLEMENTARY INFORMATION section of 

this document. 

FOR FURTHER INFORMATION CONTACT: For 

technical questions concerning this 

action, contact DK Deaderick, 121 Air 

Carrier Operations Branch, Air 

Transportation Division, Flight 

Standards Service, Federal Aviation 

Administration, AFS–220, 800 

Independence Avenue SW., 

Washington, DC 20591; telephone (202) 

267–7480; email dk.deaderick@faa.gov. 

For questions regarding the 

Department’s disability regulation (14 

CFR part 382), contact Clereece Kroha, 

Senior Attorney, Office of Aviation 

Enforcement and Proceedings, 

Department of Transportation, 1200 

New Jersey Avenue SE., Washington, 

DC 20590; telephone (202) 366–9041; 

email clereece.kroha@dot.gov. 

SUPPLEMENTARY INFORMATION:

Table of Contents 

I. Executive Summary 

A. Overview of Final Rule 

B. Summary of Cost Savings 

II. Authority for This Rulemaking 

III. Background 

A. Statement of the Problem 

B. Summary of the NPRM 

C. Differences Between Notice of Proposed 

Rulemaking and Final Rule 

D. General Overview of Comments 

IV. Discussion of Public Comments and Final 

Rule 

A. Applicability, Effective Dates and 

Compliance 

B. Definition of Portable Oxygen 

Concentrator 

C. Portable Oxygen Concentrator 

Acceptance Criteria 

1. Food and Drug Administration 

Clearance or Approval 

2. Radio Frequency Emissions 

3. Hazardous Materials 

4. Maximum Oxygen Pressure 

D. Manufacturer Label 

E. Manufacturer Determination of 

Conformance to Acceptance Criteria 

F. Prohibition on Smoking or Open Flame 

G. Operational Requirements 

1. Exit Seats 

2. Stowage of Portable Oxygen 

Concentrators 

H. Discussion of Special Federal Aviation 

Regulation No. 106 Requirements 

Excluded From Final Rule 

1. Special Federal Aviation Regulation No. 

106 Requirements Addressed in Existing 

Regulations 

2. Special Federal Aviation Regulation No. 

106 Requirements Excluded in Their 

Entirety 

I. Miscellaneous 

J. Technical Amendments 

K. Nondiscrimination on the Basis of 

Disability in Air Travel 

1. Mandatory Acceptance of POCs That 

Meet FAA Acceptance Criteria 

2. Other Amendments to 14 CFR Part 382 

V. Regulatory Notices and Analyses 

A. Regulatory Evaluation 

B. Regulatory Flexibility Determination 

C. International Trade Impact Assessment 

D. Unfunded Mandates Assessment 

E. Paperwork Reduction Act 

F. International Compatibility and 

Cooperation 

G. Environmental Analysis 

VI. Executive Order Determinations 

A. Executive Order 13132, Federalism 

B. Executive Order 13211, Regulations 

That Significantly Affect Energy Supply, 

Distribution, or Use 

VII. How To Obtain Additional Information 

A. Rulemaking Documents 

B. Comments Submitted to the Docket 

C. Small Business Regulatory Enforcement 

Fairness Act 

I. Executive Summary 

A. Overview of Final Rule 

This final rule affects the use of POCs 

on board aircraft in operations 

conducted under title 14 of the Code of 

Federal Regulations (14 CFR) parts 121, 

125, and 135, by replacing the existing 

FAA case-by-case approval process for 

each make and model of POC in Special 

Federal Aviation Regulation (SFAR) No. 

106, with FAA acceptance criteria. 

Under SFAR No. 106, each time the 

FAA approves a specific model of POC 

for use on board aircraft, the agency 

updates the list of approved POCs in the 

SFAR.1

This final rule removes SFAR No. 106 

and replaces it with POC acceptance 

criteria and specific labeling 

requirements to identify POCs that 

conform to the acceptance criteria. POCs 

that conform to the final rule acceptance 

criteria will be allowed on board aircraft 

without additional FAA review and 

rulemaking. 

As with existing requirements for 

FAA approval of POCs that may be used 

on aircraft, the final rule acceptance 

criteria and labeling requirement only 

apply to POCs intended for use on board 

aircraft. Table 1 provides a comparison 

of the final rule acceptance criteria and 

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2POC models previously listed as approved for 

use on board aircraft in SFAR No. 106 received 

approval because they satisfied the criteria set forth 

in SFAR No. 106. The POC acceptance criteria 

identified in this final rule are based on existing 

SFAR No. 106 requirements that must be satisfied 

before the FAA identifies a POC in SFAR No. 106 

as approved for use on aircraft. Thus, a POC model 

identified in SFAR No. 106 satisfies the acceptance 

criteria. 

labeling requirement with related SFAR 

No. 106. 

TABLE 1—COMPARISON OF FINAL RULE ACCEPTANCE CRITERIA AND LABELING REQUIREMENT WITH RELATED SFAR NO. 

106 REQUIREMENTS

Related SFAR No. 106 requirements Final rule acceptance criteria and labeling requirement 

Food and Drug Administration (FDA) clearance to 

market the device.

The POC must be regulated by the FDA (section 2(2))

Note: To satisfy this requirement, manufacturers provide the FAA with the FDA letter granting approval to 

market the device (the FDA response to a manufacturer’s 510(k) submission).

The POC manufacturer has received FDA clearance to 

legally market the device in the United States. 

Hazardous materials ............ The POC may not contain hazardous materials as determined by the Pipeline and Hazardous Materials 

Safety Administration (section 2(1)).

Note: To satisfy this requirement, manufacturers currently provide the FAA with a Pipeline and Hazardous Materials Safety Administration (PHMSA) determination letter stating that the POC is not subject 

to the Hazardous Materials Regulations (HMR) (49 

CFR parts 171–180).

The POC must not contain any hazardous materials 

subject to the HMR, except as provided for batteries 

in the exceptions for crewmembers and passengers 

(49 CFR 175.10). 

The maximum oxygen pressure generated by the POC 

must fall below the threshold for the definition of a 

compressed gas as per the HMR. 

Radio frequency (RF) emissions.Operator must determine that POC does not cause interference with the electrical, navigation or communication equipment on the aircraft on which the device is to be used (section 3(a)(1)).

Note: To satisfy this requirement, it is current practice 

for operators to use testing data provided by POC 

manufacturers regarding the RF emissions of a specific POC model. Manufacturers currently complete 

testing in accordance with RTCA standard 160G, 

Section 21, Category M.

The POC’s RF emissions do not interfere with aircraft 

systems. 

Identification of POCs safe 

for use on board aircraft.

POC model must be identified in SFAR No. 106 as approved for use on board aircraft prior to use on board 

aircraft in part 121, 125, and 135 operations (sections 2, 3(a)).

Note: Specific POCs approved for use on board aircraft 

are identified in SFAR No. 106 by manufacturer and 

model name. Although some POC manufacturers 

affix a label indicating FAA approval for use on board 

aircraft, there is no current FAA requirement for a 

label indicating this approval.

In order to be used on aircraft, a label must be affixed 

to the POC indicating compliance with acceptance 

criteria pertaining to FDA clearance to market the device, hazardous materials, and RF emission limits. 

POC models identified in existing SFAR No. 106 satisfy 

the acceptance criteria and will be exempt from the 

labeling requirement. These POC models will continue to be identified in the regulatory text. 

This final rule requires all POC 

models to conform to the acceptance 

criteria.2 Further, any POC model that 

was not previously identified in SFAR 

No. 106 as approved for use on aircraft 

must also bear a label indicating 

conformance with the acceptance 

criteria before it may be used on board 

an aircraft. This label will facilitate 

passenger and crew recognition of POCs 

that may be used in the cabin during all 

phases of flight. 

SFAR-approved POC models need not 

bear a label. The final rule regulatory 

text includes a list of POCs approved in 

accordance with SFAR No. 106 so that 

passengers and crewmembers can 

continue to identify these POCs as 

approved for use on board aircraft. 

In addition, this final rule eliminates 

SFAR No. 106 requirements related to 

POC use on board aircraft that are 

addressed elsewhere in titles 14 or 49 of 

the CFR. This final rule also eliminates 

specific SFAR No. 106 requirements 

applicable to passengers that are not 

necessary for safe POC use on board 

aircraft, and impose an unnecessary and 

unreasonable paperwork burden on 

POC-using passengers and their 

physicians as well as crewmembers and 

aircraft operators. This final rule also 

increases accessibility in air travel for 

passengers who require oxygen therapy 

during flight. Table 2 summarizes the 

final rule disposition of all SFAR No. 

106 provisions. 

TABLE 2—SUMMARY OF SFAR NO. 106 PROVISIONS AND DISPOSITION IN FINAL RULE

Summary of SFAR No. 106 provision Description of disposition 

in final rule 

• Requirement that the POC is legally marketed in the United States in accordance with FDA 

requirements (section 2(2)).

• Requirement for operator to determine that POC does not cause interference with the electrical, navigation or communication equipment on the aircraft on which the device is to be 

used (section 3(a)(1)).

SFAR No. 106 Provisions Reflected in Acceptance Criteria and Labeling Requirement. 

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TABLE 2—SUMMARY OF SFAR NO. 106 PROVISIONS AND DISPOSITION IN FINAL RULE—Continued 

Summary of SFAR No. 106 provision Description of disposition 

in final rule 

• Prohibition on POCs containing hazardous materials as determined by the Pipeline and Hazardous Materials Safety Administration (section 2(1)). 

• POC model must be identified in SFAR No. 106 prior to use in part 121, 125, and 135 operations (sections 2, 3(a))*. 

• Prohibition on smoking or open flame near POC (section 3(a)(2)) ............................................

• Prohibition on seating a passenger using a POC in an exit seat (section 3(a)(4)). ...................

SFAR No. 106 Provisions Retained. 

• Requirement to stow POC during movement on the surface, takeoff, and landing (section 

3(a)(3)). 

• POC model must be identified in SFAR No. 106 prior to use in part 121, 125, and 135 operations (sections 2, 3( a))*. 

• ‘‘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.’’ (section 3(a)(6)).

SFAR No. 106 Provisions Eliminated Because 

Addressed in Other Existing Regulations. 

• Requirement for POC user to ensure that POC batteries in carry-on baggage are protected 

from short circuit and are packaged in a manner that protects them from physical damage 

(section 3(b)(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.’’ (section 3(a)(6)).

SFAR No. 106 Provisions Eliminated Because 

Addressed in Other Existing Regulations. 

• Requirement for POC user to ensure that POC batteries in carry-on baggage are protected 

from short circuit and are packaged in a manner that protects them from physical damage 

(section 3(b)(6)). 

• Requirements for POC user to obtain a physician’s statement and provide notice to pilot and 

aircraft operator regarding POC use and contents of physician statement (sections 3(a)(5) 

and 3(b)(3)).

SFAR No. 106 Provisions Eliminated in Their 

Entirety. 

• Requirement for POC user to be capable of responding to alarms or to travel with a person 

who can perform these functions (section 3(b)(1)). 

• Requirement for POC user to ensure that the POC is free of petroleum products or signs of 

excessive wear or abuse (section 3(b)(2)). 

• Prohibition on use of salves and lotions unless ‘‘oxygen approved’’ (section 3(b)(4)) 

• Requirement for passenger to carry a sufficient number of batteries for duration of flight (section 3(b)(5))**. 

* The list of POCs currently identified in SFAR No. 106 will be maintained in parts 121, 125 and 135. A detailed discussion regarding the identification of POCs that conform to the acceptance criteria is provided in the preamble discussion, ‘‘Manufacturer Label.’’ 

** Air carriers may require passengers using a POC to bring an adequate number of batteries to power a POC. See 14 CFR 382.133. 

This final rule also includes several 

conforming changes to 14 CFR part 382 

to ensure that the Department’s rule 

requiring carriers to accommodate 

passengers with disabilities who are 

traveling with POCs is consistent with 

the FAA changes to POC carriage and 

use on aircraft. 

Finally, the amendments provided in 

this final rule are consistent with the 

retrospective regulatory review 

requirements of Executive Order 13563. 

On January 18, 2011, the President 

signed Executive Order 13563, 

Improving Regulation and Regulatory 

Review. Among other things, Section 6 

of that Executive Order directs agencies 

to conduct a retrospective analysis of 

existing rules. Specifically, Executive 

Order 13563 provides that ‘‘[t]o 

facilitate the periodic review of existing 

significant regulations, agencies shall 

consider how best to promote 

retrospective analysis of rules that may 

be outmoded, ineffective, insufficient, 

or excessively burdensome, and to 

modify, streamline, expand, or repeal 

them in accordance with what has been 

learned.’’ 

Consistent with Executive Order 

13563, the FAA routinely evaluates 

existing regulations and other 

requirements. The FAA works to 

identify unnecessary, duplicative, or 

ineffective regulations and to mitigate 

the impacts of those regulations, where 

possible, without compromising safety. 

As part of the FAA’s continuing 

obligation to review its regulations, the 

agency conducted an analysis of SFAR 

No. 106 and determined that it involves 

several unnecessary burdens. As a result 

of this determination and the resulting 

final rule amendments, the final rule 

will provide relief to POC 

manufacturers, passengers who use a 

POC, aircraft operators and the FAA. 

The final rule will provide relief to POC 

manufacturers and the FAA by 

eliminating the SFAR No. 106 POC 

approval process, to passengers who use 

a POC by eliminating the FAA 

requirement to obtain a physician’s 

statement, and to aircraft operators by 

eliminating the requirements for 

crewmember review of the physician’s 

statement and pilot in command (PIC) 

notification. The quantification of 

benefits follows the same methodology 

as the proposed rule as the agency did 

not receive negative comments on this 

methodology. The agency presents cost 

savings in Table 3 below. 

The total cost savings from this final 

rule is $39.5 million ($27.6 million at 

7% present value and $33.6 million at 

3% present value). The largest cost 

savings of $39 million occurs from the 

reduction of crew time to review the 

physician’s statement. These are the 

same estimated benefits and costs as 

presented for the proposed rule and 

since the FAA received no comments 

regarding these estimates, there are no 

changes to this final rule. 

B. Summary of Cost Savings 

The FAA estimates that 

manufacturers will save $108,000 over 

ten years because they will no longer 

have to petition the FAA for rulemaking 

with each new device they want to add 

to the list of POCs approved for use 

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3 Initially, SFAR No. 106 applied to part 119 

certificate holders conducting operations under part 

121. In a technical amendment published January 

12, 2007 (72 FR 1442), the FAA extended the 

requirements of SFAR No. 106 to part 119 

certificate holders conducting operations under 

parts 125 and 135. 

4 71 FR 53956 (Sept. 12, 2006); 74 FR 2354 (Jan. 

15, 2009); 75 FR 742 (Jan. 6, 2010); 75 FR 39632 

(July 12, 2010); 77 FR 4220 (Jan. 27, 2012); 77 FR 

63221 (Oct. 16, 2012); and 79 FR 6018 (Feb. 3, 

2014). 

during flight on board aircraft. These 

cost savings will be reduced slightly 

because manufacturers will incur an 

estimated total one-time cost of $22,000 

to comply with the labeling 

requirement. The FAA estimated 

additional cost savings because of the 

discontinuation of certain requirements 

from SFAR No. 106. Table 3 presents 

total estimated cost savings. 

TABLE 3—TOTAL ESTIMATED COST SAVINGS

Cost savings 7% Present 

value savings 

3% Present 

value savings 

FAA Savings—No SFAR ............................................................................................................. $91,644 $68,871 $80,519 

Manufacturer Savings—No petition for rulemaking ..................................................................... 108,000 75,853 92,126 

Removal of FAA requirement for user to obtain a physician’s statement for POC use on aircraft .......................................................................................................................................... 569,961 401,645 486,914 

Removal of FAA requirement for crew review of physician’s statement and PIC notification .... 38,726,085 27,083,677 32,972,652 

Total Cost Savings ............................................................................................................... 39,495,690 27,630,045 33,632,212 

II. Authority for This Rulemaking 

The FAA’s authority to issue rules on 

aviation safety is found in Title 49 of the 

United States Code. 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. 

This rulemaking is promulgated 

under the authority described in 49 

U.S.C. 106(f), which vests final 

authority in the Administrator for 

carrying out all functions, powers, and 

duties of the administration relating to 

the promulgation of regulations and 

rules, and section 44701(a)(5), which 

requires the Administrator to 

promulgate regulations and minimum 

standards for other practices, methods, 

and procedures necessary for safety in 

air commerce and national security. 

Further, 49 U.S.C. 41705 provides the 

Secretary of Transportation the 

authority to prohibit discrimination 

against a qualified individual with a 

disability in air travel. 

III. Background 

A. Statement of the Problem 

On July 12, 2005, the FAA published 

a final rule adding SFAR No. 106 to part 

121 of title 14 (70 FR 40156). The final 

rule adding SFAR No. 106 permitted the 

use of POCs identified in the SFAR to 

address the needs of passengers 

requiring oxygen therapy while 

traveling on board aircraft. 

Prior to SFAR No. 106, passengers 

could carry and operate equipment 

generating, storing or dispensing 

medical oxygen on board an aircraft 

only if the equipment was furnished by 

the certificate holder and certain other 

conditions prescribed in 14 CFR 

121.547, 125.219 and 135.91 were 

satisfied. In 2005, only a limited number 

of air carriers provided compressed 

medical oxygen, for a fee, to passengers 

who required medical oxygen therapy 

during flight. Because compressed 

oxygen is considered a hazardous 

material, it was an expensive and 

logistically challenging exercise for air 

carriers to provide medical oxygen. 

Today, virtually no certificate holders 

conducting part 121 operations provide 

in-flight medical oxygen for a fee to 

passengers. 

Further, passengers requiring oxygen 

therapy during travel also faced 

difficulty coordinating service between 

the carrier and the medical oxygen 

supplier to ensure coverage at the 

terminal, on board the aircraft, and gateto-gate. Sometimes, passengers would 

spend at least part of the time travelling 

without medical oxygen due to service 

problems with the oxygen supplier. 

In 2002, POCs were brought to the 

attention of the FAA as a new portable 

technology for dispensing medical 

oxygen for purposes of oxygen therapy. 

POCs work by filtering nitrogen from 

the air and providing the POC user with 

oxygen at a concentration of 

approximately 90 percent. Thus, POCs 

do not require the same level of special 

handling as compressed oxygen. 

However, due to existing FAA 

regulations applicable to the use of 

devices that dispense oxygen 

(§§ 121.574, 125.219, and 135.91), 

including POCs, the FAA informed the 

POC community that an exemption 

would be required for a passenger to 

carry on and operate a POC that the 

passenger supplied for his or her own 

use (i.e., not furnished by the aircraft 

operator). 

Rather than wait for petitions for 

exemption from the existing regulations 

(§§ 121.574, 125.219, and 135.91), the 

FAA completed rulemaking to address 

the issue of passenger-supplied POCs by 

adding SFAR No. 106 to title 14. See 69 

FR 42324 (July 14, 2004) and 70 FR 

40156 (July 12, 2005). SFAR No. 106 

allows passengers to carry and operate 

their own POC on board an aircraft if 

the FAA has approved the specific POC 

model for use on board aircraft and 

identified the POC model in the SFAR.3

As a result of SFAR No. 106, the FAA 

has mitigated the challenges faced by 

passengers requiring oxygen therapy 

during travel and has increased the 

accessibility to air travel for many 

passengers requiring oxygen therapy by 

allowing passengers to supply their own 

POCs for use during air travel. 

Passengers may not use a POC on 

board an aircraft in part 121, 125, or 135 

operations unless the FAA has 

identified the device they wish to use in 

SFAR No. 106 as approved for use in 

such operations. In 2005, SFAR No. 106 

identified the first specific POC models 

approved for use on board aircraft. 

Although the agency intended SFAR 

No. 106 to serve as a special, temporary 

regulation, until POC performance 

standards (acceptance criteria) could be 

developed, it has remained in place for 

the last decade. See 70 FR at 40158– 

40159. During this time, the FAA has 

amended SFAR No. 106 seven times to 

identify additional POC models that 

may be used on board aircraft.4 This 

process is time-consuming for POC 

manufacturers because they must 

petition the FAA for rulemaking to add 

their POC model to the SFAR list if they 

want their POC to be approved for use 

on board aircraft. Together with a 

petition for rulemaking, manufacturers 

provide the FAA with documentation 

required for the FAA to make a 

determination whether the POC satisfies 

the requirements of the SFAR. This 

process is also time-consuming for the 

FAA because each time the FAA 

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5AC 120–95B defines POCs as ‘‘small, portable 

devices that work by separating oxygen from 

nitrogen and other gasses in the air and providing 

the user with oxygen at a concentration of more 

than 90 percent . . .’’ 

6Portable oxygen concentrators are a subset of 

portable oxygen generators defined by the FDA in 

21 CFR 868.5440. 

approves a new POC for use on board 

aircraft, the FAA must complete 

rulemaking to add the newly approved 

POC model to SFAR No. 106. 

Over the last ten years, FAA 

regulations and guidance regarding the 

use of POCs on aircraft, POC technology 

itself, and air carrier programs 

concerning the use of POCs on board 

their aircraft have rapidly evolved. The 

combined result of these initiatives is an 

increase in accessibility to air travel for 

many passengers who require oxygen 

therapy during flight. In keeping with 

the Department’s ongoing commitment 

to increase accessibility to air travel, 

this final rule removes certain 

burdensome and time-consuming 

requirements that were put in place to 

ensure safety when POC technology was 

first introduced for use on board aircraft 

but are no longer necessary. 

B. Summary of the NPRM 

On September 19, 2014, the FAA 

published an NPRM entitled 

‘‘Acceptance Criteria for Portable 

Oxygen Concentrators Used On Board 

Aircraft’’ in which the FAA proposed to 

replace SFAR No. 106 with acceptance 

criteria for POCs to be used by 

passengers on board aircraft in 

operations conducted under parts 121, 

125 and 135. See 79 FR 56288. In the 

NPRM, the FAA proposed to replace the 

burdensome SFAR No. 106 POC 

approval process with acceptance 

criteria based on SFAR No. 106 

requirements, and an additional 

requirement for POCs (carried and used 

on board aircraft) to bear a label 

indicating compliance with these 

acceptance criteria. The FAA proposed, 

however, that all SFAR-approved POCs 

would be excluded from the labeling 

requirement. Further, the proposed 

acceptance criteria and labeling 

requirements would only affect POCs 

intended for use on board aircraft. The 

FAA also proposed to eliminate several 

redundant operational requirements as 

well as paperwork requirements related 

to the physician’s statement, which are 

not necessary for aviation safety. 

The comment period for this NPRM 

closed November 18, 2014. 

C. Differences Between Notice of 

Proposed Rulemaking and Final Rule 

The final rule differs from the NPRM 

as follows: 

• Replaces the proposed prescriptive 

requirement for radio frequency (RF) 

emissions evaluation with a 

performance-based standard that allows 

POC manufacturers to determine the 

means by which to assess whether its 

POC will radiate RF emissions that 

interfere with aircraft systems. 

• Modifies verbiage for required label 

text. 

• Retains the SFAR No. 106 

prohibition on exit row seating for 

passengers using a POC and the SFAR 

No. 106 requirements pertaining to POC 

stowage. 

• Amends 14 CFR part 382 to ensure 

that it is consistent with the FAA 

changes to POC carriage and use on 

aircraft. 

D. General Overview of Comments 

The FAA received 33 comments on 

the NPRM. Commenters included 21 

individuals or anonymous commenters, 

the Airline Pilots Association (ALPA), 

Airlines for America (A4A), the 

Association of Flight Attendants (AFA), 

American Airlines, Delta Air Lines, 

Main Clinic Supply, Phillips 

Respironics, BPR Medical Limited, 

Oxygen to Go (OTG), the Mayo Clinic, 

and one commenter identified as the 

past president of the Airlines Medical 

Directors Association (AMDA). 

Although the FAA received general 

support for the NPRM from many 

commenters, some commenters 

recommended modifications to the 

proposed acceptance criteria, POC 

labeling requirements, and issues 

related to the identification of POCs that 

may be used on board aircraft. Other 

commenters did not support the 

elimination of certain SFAR No. 106 

provisions, including those pertaining 

to exit row seating for passengers using 

a POC, POC stowage, the physician’s 

statement and passenger notification of 

intended POC use to the PIC and aircraft 

operator. Comments are addressed in 

the preamble discussion entitled, 

‘‘Discussion of Public Comments and 

Final Rule.’’ 

The agency also received a request 

from OTG to reopen the comment 

period. The agency denied this request, 

because the agency satisfied the 

requirement of the Administrative 

Procedure Act to publish a general 

notice of a proposed rule in the Federal 

Register. See 5 U.S.C. 553. Both the 

request to reopen the comment period 

and the agency’s response to this 

request can be found in the docket for 

this rulemaking. 

IV. Discussion of Public Comments and 

Final Rule 

A. Applicability, Effective Dates and 

Compliance 

Currently, SFAR No. 106 applies only 

to those POC models intended for use 

on board aircraft in operations 

conducted under parts 121, 125, and 

135 of title 14 of the Code of Federal 

Regulations. SFAR No. 106 authorizes 

the use of specific POCs on board 

aircraft in operations conducted under 

parts 121, 125, or 135, if the conditions 

in the SFAR are satisfied. 

Consistent with SFAR No. 106 and 

the NPRM, this final rule applies only 

to those POC models intended for use 

on board aircraft in part 121, 125, and 

135 operations, and like SFAR No. 106 

it does not create a requirement for 

operators to allow POC use. The 

Department’s requirements for air 

carriers to allow the use of a POC on 

board an aircraft (designed to have a 

maximum capacity of more than 19 

passenger seats) continue to be found in 

14 CFR 382.133. 

In the NPRM, the agency proposed an 

effective date of 90 days after 

publication of the final rule in the 

Federal Register. Because the agency 

did not propose a separate compliance 

date, compliance would also be required 

90 days after publication in the Federal 

Register. 

The agency seeks to allow compliance 

with this final rule as soon as possible. 

The agency recognizes, however, that 

affected aircraft operators may need to 

revise operating manuals and training 

programs, and expects these revisions to 

occur within the normal course of 

business. Accordingly, the SFAR will 

remain in place until August 22, 2016 

and compliance with the new rule will 

be permitted beginning on August 22, 

2016 to allow a sufficient amount of 

time for operating manuals and training 

programs to be amended in the normal 

course of business. 

B. Definition of Portable Oxygen 

Concentrator 

As proposed, this final rule defines 

‘‘portable oxygen concentrator’’ in 14 

CFR 1.1 as a medical device that 

separates oxygen from other gasses in 

ambient air and dispenses this 

concentrated oxygen to the user. This 

definition is consistent with the 

description of POCs in existing SFAR 

No. 106. The § 1.1 definition of a POC 

added by this final rule is also 

consistent with Advisory Circular (AC) 

120–95, Portable Oxygen 

Concentrators,5 as well as the device 

description used by POC manufacturers 

and the Food and Drug Administration 

(FDA) (the federal agency with primary 

regulatory authority over POCs for 

medical use).6

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Federal Register / Vol. 81, No. 100 / Tuesday, May 24, 2016 / Rules and Regulations 33103 

7A 510(k) submission is a premarket submission 

made to FDA to demonstrate that the device to be 

marketed is at least as safe and effective, that is, 

substantially equivalent, to a legally marketed 

device (21 CFR 807.92(a)(3)) that is not subject to 

premarket approval. Submitters must compare their 

device to one or more similar legally marketed 

devices and make and support their substantial 

equivalency claims. If FDA makes a finding of 

substantial equivalence, the device is considered 

‘‘cleared.’’ Additional information regarding the 

510(k) process is available at www.fda.gov. 

8The term EMC was used throughout the NPRM 

however, EMC is a broad term used for installed 

aircraft electrical systems. Where appropriate, the 

FAA has replaced the term EMC with RF emissions 

in this final rule preamble because when a deviceby-device examination of a PED is conducted, the 

operator would consider the RF emissions of that 

device. 

9Currently, POC manufacturers provide the 

RTCA DO–160 Section 21 test qualification 

statements to the FAA; the FAA then makes the 

Continued 

By including this definition in § 1.1, 

the FAA distinguishes POCs from 

portable oxygen generators and other 

medical devices that use compressed or 

liquid oxygen for medical oxygen 

therapy. Devices that use compressed or 

liquid oxygen must satisfy separate and 

more rigorous requirements to mitigate 

the risks they present. 

C. Portable Oxygen Concentrator 

Acceptance Criteria 

Under SFAR No. 106, the FAA allows 

the carriage and use of specific POC 

models only if they are identified in the 

SFAR as approved for use on board 

aircraft. A POC may be identified in the 

SFAR only after the POC manufacturer 

has petitioned the FAA for rulemaking 

(to add the POC to the SFAR) and has 

demonstrated to the FAA that the 

specific POC model satisfies the 

requirements of the SFAR (i.e., the POC 

must be regulated by the FDA and the 

POC may not contain hazardous 

materials as determined by PHMSA). 

Each time the FAA approves a 

specific model of POC for use on board 

an aircraft, the agency must update the 

list of POCs in the SFAR through 

rulemaking. Additionally, the aircraft 

operator is responsible for determining 

that the POC does not cause interference 

with aircraft equipment. The FAA notes 

that in practice, aircraft operators use 

data supplied by POC manufacturers to 

the FAA to determine compliance with 

the requirement to ensure that a POC 

will not interfere with aircraft 

equipment. 

In the NPRM, the agency proposed to 

replace the SFAR No. 106 case-by-case 

POC approval and rulemaking with 

requirements for POCs used on board 

aircraft to conform to specified 

acceptance criteria and to bear a label 

indicating that the device conforms to 

these criteria. The proposal further 

stated that POCs conforming to the 

acceptance criteria and bearing the 

appropriate label would be allowed on 

board aircraft without further 

rulemaking. The proposed acceptance 

criteria are summarized as follows: 

• The POC manufacturer complies 

with all FDA requirements to legally 

market the device in the United States. 

• The POC does not contain any 

hazardous materials subject to the HMR 

except as provided for in the exceptions 

for crewmembers and passengers in 49 

CFR 175.10 for batteries used to power 

electronic devices when operator 

approval is not required. 

• The maximum oxygen pressure 

generated by the POC must fall below 

the threshold for the definition of a 

compressed gas per the HMR. 

• The POC radio frequency (RF) 

emissions must fall below the threshold 

permitted in RTCA standard 160G, 

Section 21, Category M. 

As addressed in more detail in this 

section of the preamble discussion, this 

final rule adopts the proposal with 

modifications to the RF emissions 

acceptance criterion and labeling 

requirement. 

1. Food and Drug Administration 

Clearance or Approval 

POCs are medical devices regulated 

by the FDA in accordance with the 

Federal Food, Drug, and Cosmetic Act 

(21 U.S.C. 301 et seq.), and title 21 of 

the CFR. Accordingly, manufacturers 

must obtain FDA clearance or approval 

prior to marketing a POC within the 

United States, and must comply with 

certain provisions in title 21 of the CFR, 

including but not limited to device 

registration and listing (21 CFR part 

807), labeling (21 CFR part 801), adverse 

event reporting (21 CFR part 803), and 

good manufacturing practice 

requirements (21 CFR part 820). 

SFAR No. 106 requires all POCs used 

on board aircraft in operations 

conducted under 14 CFR parts 121, 125, 

and 135 to be legally marketed as a POC, 

in compliance with FDA regulations. 

The purpose of this requirement is to 

ensure the device is actually what the 

manufacturer holds it out to be—a POC. 

To demonstrate compliance with this 

requirement, POC manufacturers submit 

evidence that the device has been 

cleared or approved by the FDA for 

marketing in the United States. The 

FAA accepts FDA premarket clearance 

in response to a 510(k) submission as 

evidence the device may be marketed in 

the United States.7

In the NPRM, the agency proposed to 

continue to require any POC used on 

board an aircraft to be cleared or 

approved by the FDA for marketing in 

the United States prior to such use. 

However, given that FDA requirements 

for legal marketing of a POC in the 

United States already apply to POCs, 

independent of the SFAR, 

manufacturers would no longer need to 

submit evidence of this clearance or 

approval to the FAA to demonstrate 

compliance because it would be 

unnecessarily burdensome. Rather, the 

FAA proposed that POCs conforming to 

the proposed acceptance criteria, 

including the manufacturer’s authority 

to legally market the device as a POC, 

would be identified by a label affixed to 

the device. This final rule adopts this 

proposed acceptance criterion without 

change. 

2. Radio Frequency Emissions 

Sections 121.306, 125.204, and 

135.144 place responsibility on the 

aircraft operator for determining which 

portable electronic devices (PED) may 

be safely used on its aircraft. Although 

the agency recognizes POCs as a type of 

PED, SFAR No. 106, includes a 

requirement for an aircraft operator to 

make a determination that the device 

does not cause interference with the 

electrical, navigation, or communication 

system of the aircraft in which the 

device will be used. The SFAR No. 106, 

section 3(a)(1) requirement pertaining to 

POC interference with aircraft 

equipment has the same effect as the 

requirements in §§ 121.306, 125.204, 

and 135.144 pertaining to all PEDs. 

Each operator may establish a method 

to make a determination regarding the 

effects of PEDs on its aircraft’s avionics 

systems. Historically, FAA guidance 

material (i.e., AC 91.21–1 and AC 120– 

95) identified one method of 

compliance with the SFAR and 

§§ 121.306, 125.204, and 135.144 by 

recommending the operator complete 

device-by-device evaluations of RF 

emissions.8 These evaluations involve 

comparing the device’s RF emissions 

against the current RTCA DO–160 

standards for installed airborne 

equipment. The FAA identified RTCA 

DO–160, Environmental Conditions and 

Test Procedures for Airborne 

Equipment, Section 21, Category M in 

guidance material for medical PEDs 

(including POCs intended for use on 

aircraft) because it established safe and 

conservative RF emissions limits for 

installed aircraft systems. 

Consistent with the historical deviceby-device approach to RF emissions 

evaluation and agency guidance, it is 

current practice for POC manufacturers 

to provide the RTCA test compliance 

statements to the FAA.9 Although 

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33104 Federal Register / Vol. 81, No. 100 / Tuesday, May 24, 2016 / Rules and Regulations 

RTCA test qualification statements available on its 

Web site for aircraft operators to use to demonstrate 

compliance with section 3(a)(1) of the SFAR. The 

RTCA compliance statements may be viewed at 

http://www.faa.gov/about/initiatives/cabin_safety/

portable_oxygen/. 10See AC 120–95, Portable Oxygen 

Concentrators. The FAA notes that while RTCA 

made significant changes to DO–160 since edition 

E was issued (December 9, 2004) and cited in 

agency guidance, Section 21, Category M 

(applicable to POCs) was not revised in either DO– 

160F or DO–160G. 

11All InFOs can be found at http://www.faa.gov/ 

other_visit/aviation_industry/airline_operators/

airline_safety/info/all_infos/. 

section 3(a)(1) of SFAR No. 106 places 

the burden upon the aircraft operator to 

assess the impact of a POC on the 

aircraft, the FAA has accepted as proof 

of non-interference, RF emissions test 

qualification statements (provided by 

POC manufacturers) that show a specific 

POC does not exceed certain maximum 

RF emissions thresholds established by 

RTCA in DO–160, Environmental 

Conditions and Test Procedures for 

Airborne Equipment.10

On October 31, 2013, the agency 

announced a new means of compliance 

with §§ 121.306, 125.204, and 135.144, 

allowing operators to expand the use of 

passenger supplied and operated PEDs 

throughout all phases of flight, based on 

a determination by the operator that the 

aircraft systems themselves are PED 

tolerant (i.e., aircraft systems safety risk 

assessment showing the systems meet 

the requirements of RTCA DO–307 or 

another PED tolerance assessment). See 

Information for Operators (InFO) 13010 

and InFO 13010SUP.11 The agency does 

not, however, require aircraft systems 

safety risk assessment of PED tolerance 

in accordance with InFO13010 and 

InFO 13010SUP. These assessment 

methods provide one means for airplane 

operators to demonstrate compliance 

with §§ 121.306, 125.204, and 135.144 

and allow PEDs to be used on board 

aircraft. It is up to each aircraft operator 

to determine whether to expand the use 

of passenger supplied and operated 

PEDs via a determination of PED 

tolerance for certain aircraft types. The 

FAA estimates that eighty percent of 

part 121 air carriers (which comprise an 

estimated 98% of total part 121 

passenger enplanements in 2013) and 

several of the largest part 135 air carriers 

have expanded PED use according to 

InFO 13010 and InFO 13010SUP. The 

remaining operators continue to rely on 

individual PED evaluations. 

In the NPRM, the agency proposed to 

require the RF emissions for each POC 

intended for use on board aircraft to be 

tested in accordance with RTCA DO– 

160G, Section 21, Category M. The 

agency also proposed to add POCs to the 

list of devices excepted from the general 

PED non-interference requirements in 

§§ 121.306, 125.204, and 135.144 to 

eliminate redundancy with the POCspecific non-interference requirements. 

This final rule retains a POC-specific 

non-interference requirement, modified 

to reflect a performance-based standard. 

The Agency recognizes that the majority 

of operators conducting part 121 

operations and several of the larger 

operators conducting part 135 

operations have already conducted 

aircraft systems safety risk assessments 

for PED tolerance in accordance with 

InFO 13010 and InFO 13010SUP with 

results allowing for continuous use of 

PEDs from gate to gate. A determination 

that an aircraft is ‘‘PED tolerant’’ would 

make an independent assessment of RF 

emissions for any PED used on that 

aircraft unnecessary. Nevertheless, 

because of the need to ensure service for 

passengers who require oxygen therapy 

during air travel, the FAA believes it is 

necessary to maintain a regulatory 

structure to ensure that passengers may 

continue to use POCs on board aircraft 

even if the aircraft operator has not 

determined that the aircraft is ‘‘PED 

tolerant.’’ Therefore, consistent with the 

SFAR and the NPRM, this final rule 

retains a requirement to assess POC RF 

emissions as one of the POC acceptance 

criteria. (The agency notes that POCs 

previously approved by the FAA for use 

on aircraft in accordance with SFAR No. 

106 that demonstrated RF emissions 

below the maximum emissions 

threshold in DO–160G, Section 21, 

Category M would not need to be 

retested or reassessed by the operators 

prior to use on board aircraft because 

those prior assessments remain valid.) 

Delta Air Lines generally supported 

inclusion of RTCA DO–160, 

Environmental Conditions and Test 

Procedures for Airborne Equipment, 

Section 21, Category M, in the proposed 

acceptance criteria. Recognizing, 

however, that FDA may require RF 

emissions assessments that may test to 

standards that could be used to 

demonstrate compliance with the FAA 

prohibition on PEDs interference with 

aircraft systems, the agency sought 

comment on whether POC 

manufacturers complete RF emissions 

assessments in accordance with 

requirements by other federal agencies 

that could also be used to demonstrate 

compliance with the generally 

applicable PED requirements. The 

agency did not receive any comments 

related to this specific issue except as 

provided by Delta. After further review 

of the proposal and other RF emissions 

assessments that POC manufacturers 

may conduct (e.g., International 

Standards Organization (ISO) 7137 and 

the FDA recognized EMC standards for 

Class II medical devices in IEC 60601– 

1–2 edition 4.0), the agency has 

determined that the proposed 

requirement to use RTCA DO–160 as the 

only means by which to evaluate POC 

RF emissions was overly prescriptive. 

Historically, the FAA identified RTCA 

DO–160 Section 21, Category M in 

guidance material for medical portable 

electronic devices intended for use on 

board aircraft. Although POCs are not 

installed aircraft systems, the agency 

identified RTCA DO–160 as one method 

to demonstrate compliance with the 

PED non-interference requirement 

because RTCA DO–160 establishes safe 

and conservative RF emissions limits for 

installed aircraft systems. The agency 

recognizes, however, that there are other 

methods to assess POC RF emissions 

and ensure that POC use will not cause 

interference with aircraft systems. Thus, 

this final rule includes a performancebased RF emissions acceptance criterion 

that allows POC manufacturers to 

determine how to assess whether their 

POC meets the aircraft system noninterference requirement before they 

affix a label to the device confirming 

that this criterion has been satisfied. 

Guidance material in AC 91.21–1C 

identifies examples of methods 

appropriate to ensure compliance with 

this requirement, including RTCA DO– 

160 and other industry EMC standards 

identified in the AC. The FAA 

emphasizes, however, that FDA 

approval or clearance to market a POC 

does not necessarily mean that the POC 

complies with the FAA’s aircraft system 

non-interference requirement. 

In addition to Delta’s comment, an 

individual commented that the POC 

manufacturer should include the 

electromagnetic interference test results 

on the POC label, eliminating the need 

for the air carrier to test the device. The 

agency clarifies that the purpose of the 

label is to identify those devices that 

conform to the FAA acceptance criteria. 

One of those criteria prohibits the POC 

from radiating radio frequency 

emissions that interfere with aircraft 

systems. Therefore, a device that bears 

the required label must also not radiate 

RF emissions such that it causes 

interference with aircraft systems. The 

POC manufacturer identifies devices 

that meet this and other criteria by 

affixing a label. In this way, the label 

indicates that the device will not radiate 

RF emissions that cause interference 

with aircraft systems and does not need 

to be retested by the aircraft operator. 

Thus, adding specific test results to the 

label would be unnecessary. 

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Federal Register / Vol. 81, No. 100 / Tuesday, May 24, 2016 / Rules and Regulations 33105 

12PHMSA is responsible for regulating and 

ensuring the safe and secure movement of 

hazardous materials by all modes of transportation, 

including aviation. To minimize threats to life, 

property or the environment due to hazardous 

materials related incidents, PHMSA’s Office of 

Hazardous Materials Safety develops the HMR and 

standards for classifying, handling and packaging 

shipments of hazardous materials within the United 

States. 

13 49 CFR 105.5 defines a hazardous material as 

a substance or material that the Secretary of 

Transportation has determined is capable of posing 

an unreasonable risk to health, safety, and property 

when transported in commerce, and has been 

designated as hazardous under section 5103 of 

Federal hazardous materials transportation law (49 

U.S.C. 5103). The term includes hazardous 

substances, hazardous wastes, marine pollutants, 

elevated temperature materials, materials 

designated as hazardous in the Hazardous Materials 

Table (see 49 CFR 172.101), and materials that meet 

the defining criteria for hazard classes and divisions 

in part 173 of subchapter C of this chapter. 

14The PHMSA final rule, Hazardous Materials: 

Transportation of Lithium Batteries, recently 

removed 49 CFR 172.102(c)(1), Code/Special 

Provision 188 and relocated it, in part to 173.185. 

See (79 FR 46012, (August 6, 2014)). Currently, 

conditional exceptions for the transportation of 

small batteries as cargo can be found in 49 CFR 

173.185. 

15The revisions to the HMR exceptions for 

hazardous materials carried by aircraft passengers 

and crewmembers have resulted in a more 

conservative approach to the carriage of lithium ion 

batteries used to power PEDs than the previous 

requirements under 49 CFR 175.10(a)(18)(2014 ed.). 

The current passenger and crewmember exceptions 

include a new requirement for approval by the air 

operator for the carriage of spare lithium ion 

batteries larger than 100 Wh (approximately 8 

grams) and have reduced the maximum Watt-hours 

for spare lithium ion batteries from 300 Wh 

(approximately 25 grams) to 160 Wh. 

16The NPRM discussion regarding the SFAR 

limitation on hazardous materials took an overly 

conservative approach in the discussion pertaining 

to limitations on spare batteries carried by aircraft 

passengers and crewmembers. 

3. Hazardous Materials 

SFAR No. 106 allows passengers to 

use one of the specific POCs identified 

in the SFAR only if the POC does not 

contain hazardous materials as 

determined by PHMSA.12 See SFAR No. 

106, section 2(1). The PHMSA 

determination required by SFAR No. 

106 is one of the prerequisites that must 

be satisfied for the FAA to identify a 

POC in the SFAR. PHMSA issues this 

determination via a letter, at the request 

of the POC manufacturer and after 

PHMSA reviews manufacturer-supplied 

information regarding the POC. 

POCs typically operate using either 

rechargeable batteries (usually lithium 

ion) or AC/DC electrical power via an 

external power cord. Although the POC 

units themselves are not considered 

hazardous materials, the lithium ion 

batteries typically used to power POCs 

are hazardous materials.13 See 49 CFR 

172.101, Hazardous Materials Table. 

However, lithium ion batteries are 

conditionally excepted from certain 

requirements of the HMR (e.g. UN 

specification packaging and labeling) if 

they meet certain size limitations (100 

Wh), package limitations, and comply 

with package marking and battery 

testing conditions of the HMR. See 49 

CFR 173.185(c). These exceptions only 

apply when the POC units are 

transported as cargo.14

Other HMR exceptions are provided 

in 49 CFR 175.10 that apply to POC 

units containing lithium ion batteries 

and associated spare batteries when 

carried on board aircraft by passengers 

and crewmembers. See 49 CFR 

175.10(a)(18). In accordance with the 

exceptions in § 175.10(a)(18), passengers 

may bring an unlimited number of 

lithium ion batteries up to 100 Wh per 

battery to power their POC. Further, as 

a result of recent amendments, 

§ 175.10(a)(18) also authorizes the 

aircraft operator to allow passengers and 

crewmembers to carry on board as 

spares up to two batteries that are larger 

than 100 Wh but do not exceed 160 Wh 

only if certain criteria are met.15

The PHMSA determination letters 

required by the SFAR were limited to a 

determination regarding the HMR 

exceptions for a POC unit containing 

small lithium ion batteries (i.e., 100 Wh 

or 8g equivalent lithium content or less) 

for transportation as cargo as these are 

the exceptions that would apply to a 

manufacturer for transportation of a 

POC unit from the point of manufacture 

to the point of retail sale (although the 

size limits that distinguish a small 

lithium ion battery are the same for both 

the transportation of such batteries as 

cargo as well as for the passenger and 

crewmember exceptions). Existing 

PHMSA determinations for SFARapproved POCs, however, do not 

include an assessment of each 

individual air carrier’s policies 

pertaining to the allowance for larger 

batteries carried as spares. 

Consistent with the proposal in the 

NPRM, this final rule eliminates the 

SFAR No. 106 provision requiring a 

PHMSA determination that the POC 

does not contain hazardous materials. 

Instead, this final rule prohibits POCs 

used on board aircraft from containing 

hazardous materials subject to the HMR 

and references the HMR. Further, as 

noted above, POC users may carry an 

unlimited number of small spare 

lithium ion batteries (i.e., lithium ion 

batteries up to 100 Wh per battery) and 

up to two larger spare lithium ion 

batteries (i.e., batteries larger than 100 

Wh but that do not exceed 160 Wh) in 

accordance with the exceptions for 

hazardous materials carried by aircraft 

passengers and crewmembers as is the 

case today.16 See 49 CFR 175.10(a)(18). 

There is no safety basis for requiring 

the PHMSA ‘‘no hazardous materials’’ 

determination letter as a prerequisite to 

the use of a POC on board an aircraft. 

The HMR conditional exceptions 

provided in §§ 175.10 and 173.185 

apply to passengers, crew and the POC 

manufacturer, respectively, independent 

of the SFAR and this final rule. Further, 

the FAA does not require a PHMSA 

determination letter prior to passenger 

carriage of any other PED that may 

contain hazardous materials and POCs 

do not present any unique hazardous 

materials safety issues that would be 

mitigated by the requirement to obtain 

a PHMSA determination letter. 

Pursuant to 49 CFR 175.10(a)(18), 

passengers seeking to use a POC 

powered by a spare lithium ion battery 

that is over 100 Wh but less than 160 

Wh are permitted to do so only with the 

approval of the operator. Given that the 

POC manufacturer cannot assume 

knowledge of and approval by each 

carrier regarding passenger and 

crewmember carriage of larger batteries, 

under this final rule, a POC 

manufacturer will be unable to label a 

POC as conforming to the final rule 

acceptance criteria if the POC has an 

installed lithium battery larger than 100 

Wh. The final rule regulatory text 

clarifies the conditions under which 

POCs used on aircraft may contain 

batteries as a power source, including 

this limitation. Nonetheless, the 

passenger is ultimately responsible for 

compliance with the exceptions in 

§ 175.10(a)(18) for spare batteries used 

to power a POC. For example, if a 

passenger wants to bring a spare lithium 

ion battery larger than 100 Wh into the 

aircraft cabin to power a POC unit, the 

passenger is responsible for compliance 

with § 175.10(a)(18) and reviewing 

airline acceptance policies. 

A manufacturer must only affix a 

label to a POC powered by an installed 

lithium ion battery that does not exceed 

100 Wh because the manufacturer 

cannot ensure compliance with the 49 

CFR 175.10(a)(18) condition under 

which a passenger may carry and use a 

battery that exceeds 100 Wh (i.e., 

approval by an aircraft operator with 

which a passenger may choose to fly). 

Adhering to this limitation will 

facilitate passenger carriage and use of 

POCs on board aircraft and ensure that 

there are no restrictions on the number 

of spare lithium ion batteries less than 

100 Wh that can be carried on board the 

aircraft for full operability of the POC 

throughout the duration of the flight(s). 

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33106 Federal Register / Vol. 81, No. 100 / Tuesday, May 24, 2016 / Rules and Regulations 

Finally, although the FAA did not 

receive any comments regarding its 

proposal to remove the requirement for 

a PHMSA determination of no 

hazardous materials, the agency notes 

that an individual commented that the 

rules pertaining to lithium ion batteries 

must be updated, citing potential 

lithium ion battery hazards. The agency 

finds that revisions to the requirements 

applicable to passenger carriage of 

lithium ion batteries generally, are 

outside of the scope of the proposal 

because the proposal was narrowly 

tailored to address only POC carriage 

and use on aircraft. Further, PHMSA 

recently updated the requirements 

applicable to lithium ion batteries as 

part of a comprehensive rulemaking 

addressing the transportation of lithium 

batteries. See 79 FR 46012 (August 6, 

2014). As a result of this update, 

PHMSA regulations pertaining to 

lithium ion batteries are now 

harmonized with the International Civil 

Aviation Organization (ICAO) Technical 

Instructions for the Safe Transportation 

of Dangerous Goods by Air. Through the 

rulemaking process, PHMSA 

determined that harmonization with the 

ICAO Technical Instructions pertaining 

to lithium ion batteries used to power 

PEDs carried by passengers and 

crewmembers on aircraft provides an 

appropriate level of safety. 

4. Maximum Oxygen Pressure 

As previously discussed, the SFAR 

No. 106 approval process requires POC 

manufacturers to obtain a PHMSA 

determination letter stating the POC 

device does not contain any hazardous 

materials. As part of this determination, 

PHMSA reviews information provided 

by the POC manufacturer regarding the 

oxygen pressure generated by a POC. If 

the POC generates oxygen pressure of 

200 kPa gauge (29.0 psig/43.8 psia) or 

greater at 20 °C (68 °F), PHMSA would 

classify the POC as an article containing 

Hazard Class 2, Division 2.2 (nonflammable, non-poisonous compressed 

gas) and the POC would be subject to 

the applicable HMR (49 CFR 173.115). 

However, a POC does not contain a 

compressed gas subject to the HMR if it 

generates an oxygen pressure below this 

threshold. 

In the NPRM, the agency proposed to 

include as a POC acceptance criterion a 

design limitation that would restrict 

POCs used on aircraft from generating a 

maximum oxygen pressure of 200 kPa 

gauge (29.0 psig/43.8 psia) at 20 °C 

(68 °F), or more. The agency did not 

receive any comments on this proposal. 

The final rule includes the proposed 

POC design limitation as one of the POC 

acceptance criterion so as to ensure that 

newly manufactured POCs used on 

board aircraft will continue to 

incorporate this existing design 

limitation, thus ensuring that POCs will 

not present the hazards associated with 

devices that generate compressed 

oxygen. Accordingly, as proposed, the 

final rule establishes a maximum 

oxygen pressure allowed for POCs 

intended for use on board aircraft. 

A POC designed to generate a 

maximum oxygen pressure of 200 kPa 

gauge (29.0 psig/43.8 psia) at 20 °C 

(68 °F), or more, would constitute a 

hazardous material and thus be subject 

to the HMR. As such, it must not be 

labeled as meeting the standards for use 

on board aircraft. 

The agency has determined that 

inclusion of the requirement regarding 

oxygen pressurization does not overlap 

with 49 CFR 173.115 or the general 

prohibition on hazardous materials in 

this final rule, because it applies a 

design standard regarding the operation 

of the device. Further, it addresses 

concentrated oxygen that falls below the 

pressure threshold for the definition of 

compressed gasses subject to 49 CFR 

173.115. 

D. Manufacturer Label 

The FAA does not currently require 

POCs to bear a label indicating FAA 

approval and compliance with the 

SFAR. Aircraft operators, crewmembers, 

and passengers must identify POCs 

approved for use on aircraft by 

reviewing the list of FAA-approved 

devices in the SFAR. 

In the NPRM, the FAA proposed to 

require POCs that satisfied the proposed 

acceptance criteria and were intended 

for use on aircraft to bear a label 

indicating that the device satisfies these 

criteria as a condition of its carriage and 

use on aircraft. However, the NPRM 

excluded SFAR-approved POCs from 

the labeling requirement. 

The FAA also proposed specific label 

attributes. The proposed label would be 

required to contain the following 

statement in red text: ‘‘The 

manufacturer of this portable oxygen 

concentrator has determined this device 

conforms to all applicable FAA 

requirements for portable oxygen 

concentrator carriage and use on board 

aircraft.’’ Finally, the agency proposed 

that the label would have to be applied 

in a manner to ensure it remains affixed 

for the life of the POC. 

Identification of POCs that satisfy 

acceptance criteria: The agency sought 

comment on the potential safety benefits 

and associated burdens of extending the 

proposed labeling requirement to all 

POC models currently identified in 

SFAR No. 106—existing and newly 

manufactured or just newly 

manufactured. Several commenters 

expressed concern regarding the 

exclusion of existing SFAR-approved 

POCs from the proposed POC labeling 

requirement. A4A, the Mayo Clinic and 

two individuals commented that the 

labeling requirement should extend to 

all POC models that may be used on 

board aircraft (those that are currently 

identified in SFAR No. 106 and those 

subsequently determined by their 

manufacturers to satisfy the proposed 

acceptance criteria). 

The individuals cited concern 

regarding potential confusion due to the 

two methods (i.e., review label and 

review list of SFAR-approved POCs) by 

which to identify POCs that may be 

used on aircraft as the basis for 

requiring all POCs to be labeled. The 

Mayo Clinic suggested that POC 

manufacturers could retrofit existing 

SFAR-approved devices through an 

inexpensive labeling method such as a 

sticker to resolve its concerns about 

potential health care provider confusion 

regarding which POCs may be used on 

aircraft. 

A4A noted that air carrier employees 

with responsibility for determining 

device acceptability should be able to 

make this determination efficiently, 

without having to refer to the CFR. A4A 

also stated that its comments on 

extending the labeling requirement to 

POCs approved under the SFAR should 

only be applied to newly manufactured 

POCs because retrofitting existing 

devices would be unreasonably 

burdensome. 

Philips Respironics objected to the 

extension of the labeling requirement to 

existing SFAR-approved POCs citing a 

significant burden and stating that 

passengers and aircraft operators would 

have sufficient means by which to 

identify POCs that may be used on 

board aircraft. 

The final rule retains the proposal to 

label POCs that have not been 

previously identified in SFAR No. 106 

as approved for use on aircraft. SFARapproved POCs will continue to be 

identified in §§ 121.574, 125.219, and 

135.91. 

The labeling requirement provides a 

simple, efficient and effective method 

by which to identify POCs that may be 

used on aircraft. In order to determine 

whether a POC may be used on an 

aircraft, a POC user or an aircraft 

operator need only examine the POC to 

determine whether it bears the label 

required by this final rule. As is the case 

today, for those POCs that do not bear 

the required label, a POC user and 

aircraft operator need only verify that 

the model is identified in the regulatory 

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text—the same process that is currently 

used to identify SFAR-approved POCs. 

The FAA maintains that it is not 

necessary or practical to require POC 

manufacturers to label POCs previously 

identified in SFAR No. 106 as approved 

for use on board aircraft. POC models 

previously identified in SFAR No. 106 

as approved for use on board aircraft 

have satisfied the SFAR No. 106 criteria 

and would also satisfy the proposed 

acceptance criteria. Further, the FAA 

expects that the use of SFAR-approved 

POC models will lessen over time as 

those POCs age and their users replace 

those older models with newer ones, 

obviating the need to retrofit existing 

SFAR-approved POC models with a 

label. 

Although the agency appreciates the 

intent of the Mayo Clinic’s comment 

regarding a ‘‘bridging strategy’’ by 

which adhesive stickers could be used 

to identify previously manufactured 

SFAR-approved POCs, a label used to 

satisfy the requirements of this final rule 

must be sufficiently durable so as to 

remain affixed to the POC for the life of 

the device and prevent the transfer to 

another type of oxygen dispensing 

device, such as a device that uses 

compressed oxygen. 

In comments related to the 

identification of SFAR-approved POCs, 

Delta Air Lines suggested that the list of 

SFAR-approved POCs provided in the 

proposed regulatory text was 

incomplete because it did not identify 

all devices that the FAA previously 

approved in accordance with the SFAR. 

The list of SFAR-approved POCs 

identified in the proposed and final rule 

regulatory text is identical to the list of 

POCs identified in SFAR No. 106. The 

agency stresses that SFAR approval is 

device-specific. For instance, while the 

SFAR identifies the SeQual Eclipse as 

approved for use on aircraft, the 

approval does not extend to any other 

variants of SeQual Eclipse models that 

were not specifically reviewed and 

approved for use on aircraft by the FAA 

and identified in the SFAR. Thus, only 

those specific POCs identified in the 

SFAR by manufacturer and model name 

are currently approved for use on 

aircraft. This final rule continues to 

identify those SFAR-approved devices 

as they appear in the SFAR, since those 

SFAR-approved POCs need not bear a 

label as a condition of their use on 

aircraft. 

Delta Air Lines further commented 

that the FAA should update the list of 

POCs approved under SFAR No. 106 

with the names of all POCs currently 

under review by the FAA, in accordance 

with the SFAR prior to publication of 

the final rule. This final rule includes a 

list of all POCs approved by the FAA 

under the SFAR. 

FAA identification of POCs that 

satisfy acceptance criteria: Several 

commenters raised issues related to the 

FAA listing of POCs that satisfy the 

FAA acceptance criteria. A4A suggested 

that the FAA maintain a list of POC 

devices that meet the FAA’s proposed 

acceptance criteria to keep industry and 

the public updated with compliant 

POCs. A4A further explained that the 

FAA should maintain a list of POCs that 

meet the acceptance criteria because of 

challenges for aircraft operators in 

determining whether a POC satisfies the 

acceptance criteria, especially in the 

instance in which a manufacturer 

incorrectly labels a device. 

The FAA disagrees with A4A’s 

comment that unless the FAA maintains 

a list of POCs that satisfy the acceptance 

criteria, POC identification will be 

unnecessarily burdensome. The process 

of examining a POC to determine 

whether it bears a label is less 

burdensome than the existing process of 

examining a POC to identify the model 

name and then verifying that the model 

is identified in the SFAR. In either case, 

a crewmember of an aircraft operator 

must examine the POC. 

A4A also recommended that the FAA 

maintain a list of POCs that are labeled 

as conforming to FAA requirements for 

POC use on board aircraft to track POCs 

that are subsequently determined to be 

non-compliant. However, the FAA has 

alternate appropriate methods by which 

to notify aircraft operators in the 

unlikely event that a POC intended for 

use on aircraft is no longer compliant 

with FAA requirements. For example, 

the FAA can provide such notice 

through a Safety Alert for Operators 

(SAFO) or an InFO, as appropriate. All 

SAFOs and InFOs are made available on 

the agency’s Web site. 

Label attributes: The final rule 

requires the label to contain the 

following statement in red text: ‘‘The 

manufacturer of this POC has 

determined this device conforms to all 

applicable FAA requirements for POC 

carriage and use on board aircraft.’’ The 

purpose of this verbiage is to facilitate 

identification of devices that conform to 

the acceptance criteria and the red color 

is expected to draw attention to the text. 

Consistent with the NPRM, this final 

rule also requires a labeling method that 

ensures the label remains affixed to the 

POC for the life of the device. The 

purpose of this requirement is to ensure 

the label is durable and cannot be 

transferred to another type of oxygen 

dispensing device (such as a device that 

uses compressed oxygen). 

Several commenters suggested 

changes related to the proposed label 

that would standardize label features in 

addition to the proposed required text 

and color. A4A commented that the 

FAA should mandate additional specific 

label attributes so that labels are 

identical and can be easily recognized 

by gate agents. 

Philips Respironics commented that 

the proposed label text is overly 

burdensome due to the length of the text 

and the color requirement. This 

commenter proposed an alternate label 

that states, ‘‘Complies with FAA 

requirements for airline use’’ and 

includes an airplane graphic. Together 

with this alternate label, Philips 

Respironics suggested a POC manual 

update to further describe the label. 

Main Clinic Supply supported the label 

example included in the Philips 

Respironics comment. 

The agency has considered comments 

regarding additional standard label 

features but has determined that it is 

unnecessary to require standardized 

features beyond the proposed label 

verbiage and text color. The use of red 

text is sufficient to draw attention to the 

label identifying a POC that may be 

carried and used on board an aircraft. 

The specific label language proposed 

in the NPRM and included in this final 

rule is necessary to facilitate the 

identification of the device as a POC 

that satisfies the acceptance criteria for 

POCs intended for use on board aircraft. 

A more generic or general label such as 

the label proposed by Philips 

Respironics and supported by Main 

Clinic Supply would not effectively 

serve this purpose. The agency is aware 

that manufacturers of some POC models 

approved under SFAR No. 106 may 

have voluntarily applied labels similar 

to the label recommended by Philips 

Respironics and Main Clinic Supply. 

The FAA determined, however, that the 

label proposed by commenters could 

hinder a passenger’s ability to use an 

SFAR-approved POC by introducing 

confusion into the POC identification 

process due to multiple similar labels 

(i.e., labels currently affixed to some 

SFAR-approved POCs and the label 

proposed by commenters). The only 

label that may be used to determine 

compliance with this final rule and to 

ascertain whether a POC may be used 

on board an aircraft is a label that 

exhibits the verbiage and color criteria 

specifically provided in this final rule. 

Further, the FAA analyzed the costs 

associated with the NPRM labeling 

requirement and estimated that the 

requirement would not result in a 

significant burden. Commenters did not 

challenge the FAA assumptions that 

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provide a basis for the estimate of the 

labeling costs in the NPRM. Given that 

the final rule label verbiage includes 

only minimal changes from the 

proposed label verbiage, the final rule is 

not expected to result in a significant 

burden to POC manufacturers. 

Additionally, the FAA notes that, 

although the agency supports the 

Philips Respironics comment regarding 

POC manufacturer manual updates to 

describe the label, it would reach 

beyond the scope of the proposal for the 

FAA to require POC manufacturers to 

include additional information in the 

POC user manual. However, the FAA 

encourages manufacturers to inform 

POC users of issues pertaining to POC 

use on board aircraft. 

Finally, A4A commented that if the 

POC acceptance criteria were to change, 

the FAA should change the label 

requirements to distinguish those POCs 

that meet the new acceptance criteria 

from those that do not meet the new 

acceptance criteria. The agency will 

consider this comment if it finds that a 

future rulemaking is required to revise 

POC acceptance criteria. 

E. Manufacturer Determination of 

Conformance to Acceptance Criteria 

Two individuals questioned whether 

the FAA should rely on POC 

manufacturers to determine that a POC 

is safe and fits within the regulatory 

requirements. One of the individual 

commenters recommended that POC 

manufacturers demonstrate compliance 

with the acceptance criteria to the FAA 

before labeling the device as satisfying 

those criteria. In a related comment, 

Delta Airlines recommended that the 

FAA should require POC manufacturers 

to provide airlines with the data that 

demonstrates compliance with the 

acceptance criteria at the airlines’ 

request. 

The FAA employs a range of oversight 

approaches throughout title 14. The 

process in this final rule that allows 

manufacturers to self-certify that their 

POC conforms to all applicable 

requirements for use on board aircraft 

and to affix a label that can be reviewed 

by aircraft operators and passengers is 

consistent with other existing agency 

oversight practices. For example, child 

restraint system (CRS) manufacturers 

self-certify (via a label) that their CRS 

meets all applicable performance 

criteria and is approved for use on 

aircraft. In another example, the 

Technical Standard Order (TSO) 

program involves a process where a 

manufacturer makes statements of 

conformance to the standards in a 

particular TSO for many different types 

of articles used on aircraft. 

In the case of POCs, the FAA has 

determined that the devices present 

minimal risk to aircraft operations. 

Additionally, the proposed and final 

rule acceptance criteria for POCs 

leverage existing regulatory 

requirements that are applicable to 

POCs and relevant to the safe carriage 

and use of POCs, including the use of 

POCs on board aircraft. The purpose of 

the label applied by POC manufacturers 

is to facilitate aircraft operator and 

passenger identification of devices that 

meet the acceptance criteria required for 

POCs intended for use on board aircraft. 

Accordingly, a case-by-case POC 

approval process is unnecessarily 

burdensome to mitigate any potential 

risk presented by POCs. An aircraft 

operator seeking specific information 

regarding a POC may reach out to a POC 

manufacturer without FAA regulation. 

The agency also notes that POC user 

manuals and POC manufacturer Web 

sites also provide information 

pertaining to the attributes and 

functions of the associated POCs. 

F. Prohibition on Smoking or Open 

Flame 

SFAR No. 106 prohibits smoking or 

open flame within 10 feet of any person 

using a POC. In the NPRM, the agency 

proposed to retain this restriction. The 

agency did not receive any comments 

on the proposal to retain the SFAR 

prohibition on smoking or open flame 

near a person using a POC. Accordingly, 

the final rule includes this proposal 

without change. 

Although the risk posed by 

concentrated oxygen is minimal when 

generated at a pressure below that 

which would trigger the application of 

the HMR, given the unique environment 

of an aircraft, the agency has determined 

that it is reasonable to provide an 

additional margin of safety by 

prohibiting smoking or open flame in 

the vicinity of a person using a POC. 

Accordingly, the agency will maintain 

the existing prohibition on smoking or 

open flame within 10 feet of a person 

using a POC by extending the smoking 

prohibitions in existing §§ 121.574, 

125.219, and 135.91 to POCs and adding 

language to specifically prohibit an 

open flame. 

The smoking prohibition in existing 

§§ 121.574, 125.219, and 135.91 

effectively results in a prohibition on an 

open flame. However, given the risks 

created by smoking near a person using 

medical oxygen and the storage of such 

oxygen, in this final rule the agency will 

ensure that this restriction is clear by 

explicitly prohibiting an open flame in 

addition to smoking. 

Finally, as proposed, this final rule 

amends the regulatory text in 

§ 125.219(b) to prohibit smoking not 

only within 10 feet of where medical 

oxygen is being used but also within 10 

feet of where it is stored. This 

amendment is consistent with the 

preamble for the final rule issuing 

§ 125.219 as well as the prohibitions on 

smoking within 10 feet of the location 

of medical oxygen storage or use in 

§§ 121.574 and 135.91. See 45 FR 67214, 

67230 (October 9, 1980). 

G. Operational Requirements 

1. Exit Seats 

Section 3(a)(4) of SFAR No. 106 

prohibits a person using a POC from 

sitting in an exit row. The FAA 

proposed to eliminate this SFAR No. 

106 provision from the final rule. 

AFA and an anonymous commenter 

recommended that the FAA retain the 

provision in SFAR No. 106 prohibiting 

a passenger from using a POC while 

sitting in an exit row. Both commenters 

noted that POC tubing would create 

obstacles in the exit row. AFA stated 

that generally, certificate holders should 

have the responsibility for determining 

the suitability of passengers who occupy 

exit seats; however, they maintained 

that an explicit restriction on exit row 

seating would eliminate any ambiguity 

about a POC user’s ability to assist in an 

emergency. 

The FAA agrees with commenters in 

that a passenger’s ability to perform exit 

row functions could be impeded by the 

presence of the device, possibly creating 

a tripping hazard and an obstacle to 

egress. Thus, although §§ 121.585 and 

135.129 require the certificate holder to 

determine the suitability for passengers 

it permits to occupy exit seats, the final 

rule retains the SFAR No. 106 provision 

prohibiting passengers using a POC 

from sitting in exit seats to eliminate 

any potential ambiguity pertaining to 

whether a passenger using a POC may 

occupy an exit seat. 

2. Stowage of Portable Oxygen 

Concentrators 

SFAR No. 106, section 3(a)(3) states 

that during movement on the surface, 

takeoff, and landing, the POC must 

either be stowed under the seat in front 

of the user, or in another approved 

stowage location, so as not to block the 

aisle way or entryway into a row. 

Further, SFAR No. 106 limits the 

location of POC use to 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. 

However, FAA regulations in parts 121, 

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125, and 135, also address the stowage 

of carry-on items and carriage of cargo 

in the passenger cabin to ensure an 

appropriate stowage location and that 

emergency exit row access is not 

hindered by carry-on items or cargo. See 

§§ 121.285, 121.589, 125.183, and 

135.87. Thus, the FAA proposed to 

eliminate the POC stowage requirement 

in SFAR No. 106. 

AFA recommended that the FAA 

retain the requirements in section 

3(a)(3) of SFAR No. 106 that pertain to 

POC stowage. AFA stated that, for 

consistency with existing medical 

oxygen rules that require certificateholder provided equipment to be 

‘‘appropriately secured,’’ (§§ 121.574, 

125.219 and 135.91) the final rule 

regulatory text should continue to 

address stowage requirements for 

passengers’ POCs. The commenter 

stated that some operators might 

conclude that only devices furnished by 

the certificate holder are required to be 

secured or stowed unless POC stowage 

is specifically addressed. 

Although the FAA continues to 

expect that POC stowage will be 

addressed in an operator’s carry-on 

baggage program in accordance with the 

requirements of 14 CFR 121.285, 

121.589, 125.183 and 135.87, the FAA 

agrees with the commenter that 

retaining and specifically addressing 

POC stowage (and thereby reinforcing 

POC stowage requirements) could 

increase the likelihood of safe stowage 

of passenger supplied POCs. 

Accordingly, as found in SFAR No. 106, 

this final rule includes a specific 

requirement for POCs to be stowed 

during movement on the surface, 

takeoff, and landing. 

Notably, the user manuals for 18 of 

the POC models currently approved 

under SFAR No. 106 specify oxygen 

tube length. Every manual specifying 

oxygen tube length indicates the 

associated POC has at least 7 feet of 

tubing, which is long enough to allow 

a passenger to use a device stowed 

under a seat. 

H. Discussion of Special Federal 

Aviation Regulation No. 106 

Requirements Excluded From Final Rule 

The FAA has determined that many of 

the requirements included in SFAR No. 

106 are overly prescriptive or redundant 

with existing rules and are therefore not 

necessary. Accordingly, the FAA has 

not retained them in this final rule. A 

discussion of the SFAR No. 106 

requirements excluded from this final 

rule follows. 

1. Special Federal Aviation Regulation 

No. 106 Requirements Addressed in 

Existing Regulations 

a. Passenger Movement About the Cabin 

While Using a Portable Oxygen 

Concentrator 

SFAR No. 106, section 3(a)(6) states 

that when the PIC turns off the ‘‘Fasten 

Seat Belt Sign,’’ or otherwise grants 

permission to move about the passenger 

cabin, passengers may continue to use 

their POC while moving about the 

cabin. The agency included this 

provision in SFAR No. 106 in response 

to commenters’ concerns that the agency 

should allow passengers using a POC to 

operate the device for the entirety of the 

flight, if necessary. Therefore, in the 

final rule implementing SFAR No. 106, 

the agency stated that passengers are 

allowed to use a POC for the duration 

of the flight, including during 

movement on the surface, takeoff, and 

landing. The agency also stated that 

once passengers were allowed to move 

about the cabin of the aircraft, they 

would be allowed to bring the POC with 

them. See 70 FR at 40159. 

In the NPRM, the agency proposed to 

remove section 3(a)(6) of the SFAR. 

Section 3(a)(6) of the SFAR is 

unnecessary because there are no 

regulations directed at passengers using 

a POC that would limit their movement 

about the cabin when passenger 

movement is permitted by the PIC. 

Accordingly, as proposed in the NPRM, 

the final rule does not include a 

provision similar to section 3(a)(6) of 

the SFAR. The agency did not receive 

any comments on the proposed 

elimination of this SFAR No. 106 

provision. 

b. Protection of Batteries From Short 

Circuit 

SFAR No. 106, section 3(b)(6) requires 

passengers to ensure all POC batteries 

carried on board the aircraft in carry-on 

baggage are protected from short circuit 

and 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). 

Additionally, when a passenger carries 

a POC on board an aircraft as carry-on 

baggage, and does not intend to use the 

POC during the flight, the passenger 

must remove the battery and package it 

separately unless the POC contains at 

least two effective protective features to 

prevent accidental operation and 

potential overheating of the battery 

within the POC during transport. 

The FAA proposed to eliminate the 

SFAR No. 106 provisions applicable to 

spare batteries carried by passengers on 

board aircraft for use in POCs because 

they are unnecessary. The portion of 

SFAR No. 106, section 3(b)(6) 

addressing spare batteries is redundant 

with PHMSA regulations applicable to 

spare lithium batteries carried by 

passengers on board aircraft. See 49 CFR 

175.10(a)(18). 

A4A commented that the FAA should 

strongly recommend that POC 

manufacturers include a carrying case 

for spare lithium battery packs to ensure 

battery isolation and insulation. The 

FAA supports any action a POC 

manufacturer takes to facilitate 

passenger, crewmember, and operator 

compliance with the requirements for 

the safe carriage of lithium ion batteries 

on board aircraft, including spares. 

However, the agency does not agree that 

the commenter’s recommendation is 

necessary because PHMSA has 

identified the requirements for safe 

carriage of spare lithium batteries used 

to power all PEDs carried by aircraft 

passengers or crewmembers. See 49 CFR 

175.10(a)(18). 

PHMSA requires all lithium batteries 

to be of a type proven to meet the 

requirements of each test, including 

Test T.7 (Overcharge), in Part III, Subsection 38.3 of the UN Manual of Tests 

and Criteria. See 49 CFR 173.185 and 

175.10(a)(18). Additionally, PHMSA 

requires spare lithium batteries carried 

on board aircraft to be carried in the 

cabin in carry-on baggage and 

individually protected from short circuit 

to mitigate the risk of a fire during flight 

(e.g., by placement in original retail 

packaging, by otherwise insulating 

terminals by taping over exposed 

terminals, or by placing each battery in 

a separate plastic bag or protective 

pouch). See 49 CFR 175.10(a)(18). 

The agency notes that the SFAR 

diverges from PHMSA requirements 

pertaining to installed batteries. See 49 

CFR 175.10(a)(18). The SFAR requires a 

passenger to remove a POC battery if the 

device does not have at least two 

features that prevent accidental 

operation. The HMR, however, do not 

require an installed battery to be 

removed from any PED, which would 

include a POC that is not in use. See 49 

CFR 175.10(a)(18). 

Based on the analysis of currently 

approved POCs and PHMSA 

requirements applicable to lithium ion 

batteries carried by passengers and 

crewmembers to power PEDs, an 

independent FAA requirement for two 

protective features as a prerequisite to 

leaving an installed battery in a POC is 

unnecessary. The agency reviewed the 

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24 SFAR-approved POCs and 

determined those POCs all have at least 

two design features preventing 

inadvertent or accidental operation. 

Thus, batteries may remain in SFARapproved POCs while those POCs are 

not in use. 

In addition, current PHMSA 

regulations address the safe 

transportation of lithium ion batteries as 

well as passenger carriage of lithium ion 

batteries. Lithium batteries must be of a 

type proven to meet the requirements of 

each test, including Test T.7 

(Overcharge), in Section 38.3 of the UN 

Manual of Tests and Criteria. See 49 

CFR 173.185. 

Based on the analysis of SFARapproved POCs and the applicable 

HMR, an independent FAA requirement 

for two protective features as a 

prerequisite to leaving an installed 

battery in a POC is unnecessary. All 

POCs currently used on board aircraft 

are equipped with two protective 

features and all lithium ion batteries 

must be designed to satisfy the 

overcharge test protection, therefore, the 

risk of a fire originating from the battery 

is minimal. Accordingly, this final rule 

eliminates SFAR No. 106, section 3(b)(6) 

from title 14. 

2. Special Federal Aviation Regulation 

No. 106 Requirements Excluded in 

Their Entirety 

a. Physician Statement and Pilot in 

Command and Aircraft Operator 

Notification Requirements 

Section 3(b)(3) of SFAR No. 106 

requires passengers intending to use a 

POC to have a written statement signed 

by a licensed physician, and kept in that 

person’s possession that 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; states whether 

or not oxygen use is medically 

necessary for all or a portion of the 

duration of the trip; and specifies the 

maximum oxygen flow rate 

corresponding to the pressure in the 

cabin of the aircraft under normal 

operating conditions. 

Section 3(b)(3) of SFAR No. 106 

further requires a passenger to inform 

the aircraft operator that he or she 

intends to use a POC on board the 

aircraft and to allow the crew of the 

aircraft to review the contents of the 

physician’s statement. Similarly, section 

3(a)(5) of SFAR No. 106 requires PIC 

notification whenever a passenger 

brings and intends to use a POC on 

board the aircraft. The PIC must be 

apprised of the physician’s written 

statement required by section 3(b)(3) of 

the SFAR including the nature of the 

passenger’s oxygen needs and the 

passenger’s ability to understand 

operational and warning information 

presented by the POC. 

As proposed, the FAA will no longer 

require POC-using passengers to present 

a physician’s statement, to notify the 

aircraft operator and PIC of their 

intended POC use, to inform the PIC of 

the contents of their physician’s 

statement, and, to allow the crew of the 

aircraft to review the content of their 

physician’s statement. The FAA 

received comments related to these 

proposals from two POC suppliers 

(Main Clinic Supply and OTG), the 

Mayo Clinic, AMDA, and a number of 

individuals. The FAA has reviewed and 

considered all comments regarding the 

physician’s statement and pre-flight 

notification of POC use. 

Physician statement: Two individual 

commenters supported the FAA 

proposal to relieve passengers from 

obtaining a physician’s statement as a 

condition of their use of a POC on 

aircraft. Main Clinic Supply supported 

the proposal to relieve passengers from 

having to provide a physician statement 

commenting that the current 

requirement for a written, signed 

physician statement for every flight is 

not practical, causes many delays, and 

may inhibit POC users’ air travel. Main 

Clinic Supply also stated that 

physicians and their staff do not have 

the resources to provide POC training to 

patients, explaining that the POC user 

must be responsible for reading the POC 

operating manual and asking the 

necessary questions of their oxygen 

provider. 

OTG, AMDA, the Mayo Clinic, and 

some individual commenters did not 

support the FAA proposal to remove the 

requirement for passengers to carry a 

physician’s statement as a condition of 

POC use on aircraft. OTG, AMDA, and 

some individual commenters indicated 

that removal of the existing physician’s 

statement and notification requirements 

would cause diversions, impact 

passenger travel, and be costly to the 

airlines. Generally, commenters asserted 

that the FAA should retain the SFAR 

No. 106 requirement for a physician’s 

statement because it ensures that 

passengers seeking to use a POC on 

board an aircraft have consulted with a 

physician regarding POC use in the 

aircraft environment prior to travel. 

Commenters also challenged statements 

in the NPRM regarding POC function in 

the aircraft environment. 

The Mayo Clinic commented that it is 

particularly important for individuals 

who have ‘‘poor respiratory reserve’’ to 

have health care provider oversight. In 

this regard, the physician statement is a 

form of ‘‘safety net’’ to trigger these 

conversations between passengers and 

their treating providers. It is critical that 

these conversations occur prior to air 

travel since decompensation on board a 

flight may require urgent response. OTG 

and some individual commenters 

commented that additional interaction 

between a POC user and his or her 

physician is necessary to educate 

passengers with limited experience with 

POC use; to address discrepancies 

between the POC prescription and the 

POC provided by a supplier; and to help 

the POC user account for the effects of 

cabin pressurization on POC use. 

OTG indicated in its comments that 

the flow rate on a POC prescription may 

not be appropriate for cabin altitudes. In 

a related comment, the Mayo Clinic 

stated, ‘‘[A]lthough a physician or other 

health care provider with prescribing 

privileges writes prescriptions for 

devices to deliver supplemental oxygen, 

many providers are unfamiliar with the 

physiology of altitude.’’ OTG also 

commented that, in its experience, a 

large percentage of physicians and the 

majority of passengers incorrectly 

assume aircraft cabins are pressurized to 

sea level. OTG stated that based on this 

assumption, physicians do not provide 

their POC-using patients with 

recommendations regarding oxygen 

flow adjustments during air travel when 

most will require higher flow rates in a 

pressurized cabin than at sea level. OTG 

further asserted that the POC will not 

produce the same percentage of oxygen 

in a pressurized cabin and the oxygen 

saturation level of the passenger will be 

decreased due to the normal physics of 

the partial pressure of the oxygen on 

pulmonary tissue. 

The agency clarifies that SFAR No. 

106 does not specifically require a 

passenger to obtain a new physician’s 

statement prior to each flight. See 70 FR 

at 40161. Also, SFAR No. 106 does not 

require the physician’s statement to 

account for the duration of a specific 

flight, variables that may arise in flight 

conditions, changes in a patient’s 

oxygen needs over time, or variables 

that may arise in connection with an 

individual’s medical condition. Further, 

commenters noted that not all 

physicians may be familiar with effects 

of cabin pressure or realize that aircraft 

are not pressurized to sea level. For 

these reasons, while the SFAR No. 106 

requirement for a physician’s statement 

may result in a one-time conversation 

about a passenger’s POC use on an 

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aircraft at some point in time, the 

requirement to obtain such a statement 

may not provide the POC education and 

‘‘safety net’’ expected by commenters. 

The FAA appreciates and concurs 

with comments regarding the need for 

vigilance and understanding of all 

nuances associated with POC use on 

aircraft. The agency appreciates and has 

considered commenters’ concerns about 

the physiology of flight and its 

relationship to POC use. The FAA 

emphasizes that pre-flight preparation 

on the part of the POC-using passenger, 

working closely with an appropriate 

medical professional, should always 

occur when traveling with any medical 

device. While preparation may differ for 

each POC-using passenger, depending 

on the aircraft and kind of operation 

included in his or her travel plans, 

passengers may wish to consider such 

factors with their medical professional 

such as past experience using a POC, 

cabin pressurization, layovers, length of 

flight, and pre-flight activities that could 

lead to compromised lung function in 

flight. The FAA also encourages POCusing passengers to carry 

documentation regarding the device 

they intend to use including any 

pertinent documentation provided to 

them by a medical professional or any 

medical certificate required by the 

carriers in accordance with the 

Department’s air travel disability 

regulation in 14 CFR 382.23. 

However, the FAA believes that 

retaining the SFAR No. 106 requirement 

for a physician’s statement as evidence 

of this medical consultation is not the 

most effective education tool in those 

circumstances in which the physiology 

of altitude could come to bear on POC 

use and should not be relied on as the 

means to address the range of variables 

potentially affecting passengers using 

POCs during flight. The FAA has 

determined that it is more effective to 

provide reasoned guidance and public 

outreach to educate POC users and 

physicians regarding considerations 

pertaining to POC use during flight in a 

pressurized cabin. The FAA provides 

information on passenger health and 

safety on its Web site (e.g., http://

www.faa.gov/passengers/fly_safe/

health/comprehensive/). The FAA has 

also updated the POC-specific guidance 

in AC–120–95B and expects to update 

its Web site with information a 

passenger may want to consider when 

traveling with a POC. 

As is the case with in flight use of any 

medical device, passengers who need to 

use a POC on board an aircraft should 

always consult with an appropriate 

medical professional and their chosen 

air carrier before traveling. Doing so 

ensures that passengers are prepared for 

each flight they take, particularly if, as 

one commenter noted a prescription 

may not address adjustments that may 

be appropriate for POC use on a 

pressurized aircraft. However, the FAA 

has determined that the specific, 

regulatory requirement set forth in the 

SFAR requiring POC-using passengers 

to obtain, present, and allow for 

scrutiny of a physician’s statement, as a 

condition of admission on board an 

aircraft is particularly burdensome for 

passengers seeking to use a POC during 

air travel. 

The FAA intended for the SFAR to 

provide a framework, not previously 

available, under which persons with a 

need to use personal oxygen therapy 

could use their own devices during a 

flight, thereby increasing accessibility to 

air travel for POC-using passengers. 

With more than 10 years of experience 

with POC technology and POC use on 

aircraft, the FAA has determined that 

the requirement for a passenger to 

provide for aircraft operator, 

crewmember, and PIC scrutiny, a 

physician statement pertaining to a 

medical device that the passenger is 

solely responsible for during the flight, 

was an overly conservative addition to 

the POC oversight framework. Removing 

the requirement to obtain a physician’s 

statement affects a paperwork 

requirement; it does not affect 

passengers’ responsibility to be 

prepared for travel. The purpose of this 

final rule is to continue to provide POCusing passengers access to air travel, 

while addressing device safety for 

aircraft use; it is not intended (and is 

not within FAA authority) to set forth a 

standard of medical care for POC-using 

passengers. Further, the FAA does not 

require passengers who supply any 

other medical device for their own use 

during a flight to provide a physician’s 

statement as a condition of device usage 

during flight. 

Additionally, as mentioned 

previously, existing DOT requirements 

in 14 CFR part 382 continue to include 

a provision to further mitigate the 

possibility of medical events including 

those that could result in a diversion. 

Sections 382.23(b) and 382.133 

authorize carriers to require a passenger 

needing medical oxygen inflight to 

provide a medical certificate to ensure 

the passenger can complete the flight 

safely without requiring extraordinary 

medical assistance during the flight. 

AMDA indicated that the FAA should 

conduct additional research regarding 

the potential impact of the elimination 

of the physician’s statement. The FAA 

has determined that additional research 

is not necessary at this time because the 

FAA expects physician consultation to 

continue as appropriate for the use of 

any medical device, and that pre-flight 

notice of POC use on the aircraft will 

continue in light of the requirement for 

each aircraft operator to determine 

whether the POC bears the label 

required for use on board aircraft. 

The purpose of the SFAR and the 

FAA’s action in this final rule is to 

address continued use of POCs on 

aircraft without compromising the 

safety of the aircraft operation. The 

agency has determined the SFAR No. 

106 requirement for a physician 

statement creates an unnecessary 

burden that may not ultimately serve 

the purpose contemplated by 

commenters. The FAA emphasizes that 

removing the requirement to obtain a 

physician’s statement affects a 

paperwork requirement; it does not 

affect passengers’ responsibility to be 

prepared for travel, including obtaining 

a medical certificate if the carrier 

chooses to require one as allowed by 14 

CFR 382.23 and 382.133. All passengers 

using a medical device in an aircraft 

environment are responsible for 

preparing for the flight such that they 

can ensure that the device will function 

properly during the flight and provide 

the requisite medical support. 

Therefore, as proposed, this final rule 

discontinues the SFAR requirement for 

a physician statement. 

PIC and aircraft operator notification: 

OTG, AMDA, and several individual 

commenters did not support the 

proposal to remove the requirements for 

pre-flight notification of the aircraft 

operator and PIC regarding POC use on 

board an aircraft. These commenters, 

however, did not provide specific 

reasons for maintaining the notification 

requirements. One anonymous 

commenter asserted that advance notice 

that a passenger expects to use a POC 

would allow crewmembers to prioritize 

actions during multiple cabin events. 

Under this final rule, the PIC and 

aircraft operator (through a crewmember 

or gate agent) will continue to receive 

notice of a passenger’s POC use during 

flight as the operator determines during 

pre-boarding procedures whether the 

device has the label now required for 

POC use on the aircraft. Accordingly, as 

proposed, the FAA discontinues the 

specific requirement for passengers to 

notify the aircraft operator and PIC of 

intended POC use during a flight 

because a specific notification 

requirement is unnecessary. 

OTG also stated that several POCrelated incidents have occurred in flight 

but did not provide any specific 

examples, information, or data regarding 

such diversions or incidents. OTG 

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17 Voluntary Disclosure Reporting Program 

(VDRP), Service Difficulty Reporting System 

(SDRS), National Transportation Safety Board 

Aviation Accident and Incident Data Systems 

(NTSB), National Aeronautics and Space 

Administration Aviation Safety Reporting System 

(ASRS) and FAA Accident/Incident Data System 

(AIDS). 

further stated that the FAA should have 

contacted ‘‘air-to-ground’’ medical 

service providers to document POCrelated incidents. 

The agency reviewed air carrier safety 

data collected from 2005 through 

2014—a period of nearly 10 years—and 

found no instances of POC malfunction 

during flight or any related medical 

incident or diversion. This review 

included information from several 

accident, incident, and voluntary 

reporting databases.17 Further, no ‘‘airto-ground’’ medical service providers 

contacted the agency regarding any POC 

incidents, nor did they provide any 

comments to the agency in this regard 

during the open comment period. 

Although the FAA is removing the 

requirement for pre-flight notification, 

under existing DOT requirements in 14 

CFR part 382, carriers continue to be 

permitted to require individuals who 

wish to use a POC on aircraft to contact 

them 48 hours before scheduled 

departure. Carriers are permitted to 

require this pre-flight notification so 

they can ensure that a passenger knows 

the expected maximum flight duration 

and can use this information in 

determining the number of spare 

batteries that he or she will need to 

power the POC during the flight. 

b. Portable Oxygen Concentrator Alarms 

SFAR No. 106, section 3(b)(1) requires 

a passenger using a POC on board an 

aircraft to be capable of hearing the 

unit’s alarms and seeing alarm light 

indicators. SFAR No. 106 also requires 

passengers using a POC to have the 

cognitive ability to take appropriate 

action in response to the various POC 

caution alarms, warning alarms, and 

alarm light indicators, or travel with 

someone capable of performing those 

functions. 

In the NPRM, the FAA proposed to 

eliminate the requirement for a 

passenger using a POC on board an 

aircraft to be capable of hearing the 

unit’s alarms and seeing alarm light 

indicators. An anonymous commenter 

stated that the FAA should retain this 

requirement because a continuous audio 

alarm could be very disruptive and 

compound other abnormal events 

occurring in the cabin. The commenter 

added that the absence of alarm events 

over the last 10 years does not mean that 

an alarm event will not occur in the 

future. Additionally, OTG commented 

that in its experience, an individual may 

not be able to respond to alarms even if 

a physician states that the individual 

can respond to the POC alarms. 

Crewmembers receive training on 

how to respond to unanticipated events 

that may arise on board the aircraft 

including disruptions in the cabin and 

other abnormal events. Further, it is a 

passenger’s responsibility to read the 

POC operator’s manual and direct 

questions to their physician to ensure 

understanding of oxygen flow settings 

and the appropriate responses to alarms. 

The SFAR No. 106 requirements 

pertaining to POC alarms are based on 

information in the user manual of the 

first POC approved by the FAA. See 69 

FR at 42325. Based on a review of 20 

user manuals for POCs identified in 

SFAR No. 106, the agency has 

determined POC alarms may provide 

information regarding the general 

operation of the POC, as well as 

information regarding the power source 

and detection of the POC user’s breath. 

Since these alarms help ensure the 

device functions as intended, the FAA 

believes that removing this requirement 

will not affect aviation safety. 

The FAA also emphasizes that it has 

not identified any incidents regarding 

POC malfunctions on board aircraft 

during the period of time that POCs 

have been permitted on aircraft. A 10- 

year look-back period includes data 

from almost 78 million domestic flights 

with no adverse POC incidents. See 

http://www.transtats.bts.gov/Data_

Elements.aspx?Data=2. The agency has 

determined that this is sufficient data to 

provide an appropriate indicator of 

future POC safety. Therefore, as 

proposed, this final rule eliminates the 

SFAR No. 106 requirement pertaining to 

alarms (section 3(b)(1)). 

c. Ensuring the Portable Oxygen 

Concentrator is Free of Petroleum 

Products 

SFAR No. 106, section 3(b)(2) requires 

a passenger using a POC to ensure the 

POC 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. This 

provision is similar to a warning 

statement found in the user manual of 

the first POC approved by the FAA and 

to a provision in the medical oxygen 

rules (§§ 121.574, 125.219, and 135.91). 

See 69 FR at 42325. The agency 

proposed to eliminate this SFAR No. 

106 provision. 

OTG commented that for passengers 

who rent their POCs, the condition of 

the device and its batteries is dependent 

on the purveyor of the equipment. The 

FAA expects POC users to ensure that 

a POC they intend to use is in good 

condition so that it may function 

properly to provide the needed oxygen 

therapy whether the POC user is on the 

ground or on an aircraft. Further, while 

petroleum products may accelerate an 

existing fire, the volume of petroleum 

products necessary to accelerate a fire is 

unlikely to be found on the exterior of 

a POC, and this concern is not 

addressed as a specific requirement for 

other PEDs carried on board aircraft. 

Therefore, this final rule eliminates the 

requirements in section 3(b)(2) of SFAR 

No. 106 because the requirements are 

unnecessary. 

d. Use of Salves and Lotions 

SFAR No. 106, section 3(b)(4) states 

only oxygen approved lotions or salves 

may be used by persons using a POC on 

board an aircraft. In the NPRM, the FAA 

proposed to eliminate this prohibition 

in its entirety and did not receive any 

comments on this proposal. 

The requirement in SFAR No. 106, 

section 3(b)(4) came from the user 

manual of the first POC approved by the 

FAA. The FAA believes it is the 

passenger’s responsibility to ensure he 

or she is using products that meet the 

POC manufacturer’s requirements for 

salve and lotion usage with a POC. The 

risks and responsibilities associated 

with lotions or salves that are not 

oxygen approved or are petroleumbased are addressed in the preceding 

discussion on the elimination of the 

requirement for the user to ensure that 

the POC is free from petroleum 

products. Therefore, as proposed, this 

final rule does not retain the prohibition 

in section 3(b)(4) of SFAR No. 106. 

e. Carriage of a Sufficient Number of 

Batteries 

SFAR No. 106, section 3(b)(5) requires 

passengers intending to use a POC 

during a flight to obtain from the aircraft 

operator, or by other means, the 

duration of the planned flight and carry 

a sufficient number of batteries to power 

the device for the duration of the oxygen 

use specified in the passenger’s 

physician statement, including a 

conservative estimate of any 

unanticipated delays. In the NPRM, the 

agency proposed to eliminate this SFAR 

No. 106 requirement. 

Delta Air Lines commented that this 

final rule should retain the battery 

carriage requirements found in SFAR 

No. 106 and current 14 CFR 

382.133(f)(2) because passengers often 

mistakenly assume that electrical outlets 

are available to power portable medical 

devices. The FAA is not aware of any 

specific incidents of confusion 

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regarding availability of electrical 

outlets to power POCs. FAA guidance 

(AC 120–95B as well as previous 

editions of this AC) addresses aircraft 

operator and passenger issues pertaining 

to the use of electrical outlets to power 

POCs. Further, many air carriers, 

including the commenter, disclose 

applicable policies on their Web sites 

regarding the availability and use of on 

board electrical outlets for electronic 

devices intended for use during flight. 

The FAA encourages air carriers to 

continue this practice. 

Additionally, as noted in the Delta Air 

Lines comment, existing DOT 

regulations (14 CFR part 382) permit 

carriers to require an individual 

traveling with a POC to bring an 

adequate number of fully charged 

batteries into the cabin that will power 

the POC for no less than 150% of the 

expected maximum flight duration. See 

current 14 CFR 382.133(f)(2), revised by 

this rule to 14 CFR 382.133(h)(2). Part 

382 also requires carriers to inform 

passengers who advise the carriers of 

their intent to use a POC on board an 

aircraft about the maximum duration of 

the flight segment. See 14 CFR 

382.133(f)(1), revised by this rule to 14 

CFR 382.133(h)(1). 

OTG commented that it is almost 

impossible for the average passenger to 

assess the amount of battery power that 

they may need for the duration of a trip 

due to time zone changes, the effect of 

flow rate on battery duration and 

mistaken assumptions about their 

ability to recharge batteries between 

flights. OTG also indicated that POC 

manufacturer manuals are ‘‘overly 

optimistic’’ about battery duration, often 

basing their assumptions on data from 

new batteries. 

The Mayo Clinic commented that 

many passengers only use a POC 

temporarily, during a flight, and thus 

are unfamiliar with the device. The 

Mayo Clinic added that an FAA 

requirement for passengers using a POC 

to carry a certain amount of battery 

power, would serve as a reminder for 

the passenger and his or her health care 

provider regarding the necessity of 

sufficient power for POC use, noting 

that the consequences of inadequate 

supplemental oxygen could result in the 

need to administer medical oxygen 

during the flight or divert the aircraft. 

The FAA maintains that it is the 

passengers’ responsibility to understand 

the performance of their POC and its 

battery life under varying conditions 

and ensure their POC will enable them 

to adhere to their physician’s 

instructions. All manuals for the POCs 

identified in SFAR No. 106 have liter 

flow and battery duration charts to help 

users make informed decisions 

regarding the number of spare batteries 

they need to bring to power the device 

and it is the responsibility of passengers 

using a POC during air travel to be 

familiar with the manual and consult 

their physician and POC provider as 

necessary. As highlighted by OTG, 

passengers may also want to consider 

the age of the device and the batteries 

as they assess the batteries required to 

power the POC for the amount of time 

required. The intent of the SFAR and 

this rulemaking is to allow passengers 

needing oxygen therapy during a flight 

to have ready access to a device that can 

supply that therapy, not to oversee 

passenger medical care. 

Thus, as proposed, the FAA has 

eliminated the SFAR requirement to 

carry a certain amount of battery power. 

However, the Department continues to 

allow airlines to require individuals 

using POCs inflight to bring an adequate 

number of fully charged batteries based 

on the battery manufacturer’s estimate 

of the hours of battery life while the 

POC is in use and the maximum 

duration of the flight. Also, to facilitate 

a passenger’s ability to prepare for POC 

use during a flight, in AC 120–95B, 

published with this final rule, the FAA 

has provided references to the DOT 

requirements regarding the carriage of 

spare batteries. The FAA also expects to 

update its Web site with information a 

passenger may want to consider when 

traveling with a POC. 

I. Miscellaneous 

BPR Medical Limited recommended 

that the six continuous flow POCs 

approved under SFAR No. 106 should 

be retrofitted with an accessory to stop 

the flow of oxygen in the event that the 

POC tubing ignites. BPR states that 

during testing for fire propagation in 

tubing, BPR found that where a pulse 

dose mechanism provides oxygen, a fire 

that has developed will automatically be 

extinguished and will not propagate 

along the tubing to the oxygen source. 

The commenter added that while having 

a means to stop the flow of oxygen may 

be more of a concern where cigarettes 

might be a source of ignition, there are 

other possible sources of ignition on 

aircraft such as electro-static discharge 

from blankets. 

FDA has recently recognized a POC 

performance standard (ISO 80601–2– 

69:2014) that includes a clause stating 

that the device shall be equipped with 

a means to stop the flow of gas towards 

the patient in the case that the accessory 

(tubing) becomes ignited. This standard 

will be considered as the FDA approves 

or clears new POC models. 

Additionally, the previous FDA 

recognized performance standard for 

POCs (ISO 8359:1996 including 

Amendment 1 (2012)) stated that POCs 

shall include a means to prevent the 

propagation of fire back through the 

oxygen concentrator outlet in the case 

that the tubing ignites. Although it is 

not clear whether all of the continuous 

flow devices approved under the SFAR 

include this means to prevent fire 

propagation, the FDA is allowing 

continued use of these devices and is 

not requiring existing POCs to be 

modified to comply with the 

performance standard the agency 

currently recognizes (ISO 80601–2– 

69:2014). 

Nevertheless, the commenter’s 

suggestion to retrofit continuous flow 

POCs with an accessory to extinguish 

fire propagation in tubing is outside of 

the scope of the proposal and a 

prohibition on the use of continuous 

flow POCs on aircraft is not supported 

by aviation safety data. As previously 

noted, the FAA reviewed data from 

VDRP, SDRS, NTSB, ASRS and AIDS, 

and has not found any instances of POC 

malfunction during flight since the 

agency first published the SFAR. 

The FAA also researched the service 

difficulty report (SDR) database for the 

period beginning the time SFAR No. 106 

published (July 12, 2005) through 

December 2014, and ran multiple 

queries for the terms fires, blankets, 

POCs, electrostatic discharges, and 

insulation materials. This research 

covers a period where almost 78 million 

U.S. domestic flights occurred, revealing 

no SDRs related to POCs. See http://

www.transtats.bts.gov/Data_

Elements.aspx?Data=2. 

Finally, although the FAA has not 

identified a single instance of a fire due 

to passenger’s use of a POC on an 

aircraft, passenger-carrying aircraft are 

equipped with effective mitigation (i.e., 

fire resistant cabin materials and fire 

extinguishers) if a fire should occur. See 

14 CFR 25.853, 23.853, 121.215, 

121.309, 125.113 and 135.155. 

Accordingly, the agency has 

determined that no aviation safety data 

exists that would support further FAA 

action to preclude continuous flow POC 

models from use onboard aircraft. 

J. Technical Amendments 

This final rule makes two technical 

amendments. First, it updates a cross 

reference to the HMR that appears in 

§§ 121.574(a)(3), 125.219(a)(3), and 

135.91(a)(3) and pertains to the 

definition of a compressed gas. Second, 

it removes the OMB Control No. 2120– 

0702 from § 11.201(b) because the 

information collection burdens 

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18See, Notice—The Use of Passenger-supplied 

Electronic Respiratory Assistive Devices on Aircraft, 

October 28, 2009, https://www.transportation.gov/

sites/dot.gov/files/docs/Notice_10_28_09.pdf. 

associated with this control number 

cease to be effective when SFAR No. 

106 is removed from title 14. 

K. Nondiscrimination on the Basis of 

Disability in Air Travel 

The Air Carrier Access Act (ACAA) 

prohibits discrimination by U.S. and 

foreign carriers against passengers with 

disabilities. See 49 U.S.C. 41705. Part 

382 of title 14 contains detailed 

standards and requirements to 

implement the ACAA and to ensure that 

carriers provide nondiscriminatory 

service to passengers with disabilities. 

With regard to POCs, part 382 

establishes a framework to ensure 

accessibility for passengers using POCs 

and other respiratory assistive devices 

on aircraft, subject to applicable 

aviation safety, security, and hazardous 

materials regulations. In this final rule, 

the FAA revises its acceptance criteria 

on POCs, based on which air carriers 

may choose to, but are not required to, 

accept those POCs meeting FAA’s 

criteria. On the other hand, part 382 

mandates that carriers must accept 

POCs if they meet the FAA’s acceptance 

criteria. Accordingly, this final rule 

includes amendments to 14 CFR part 

382 to remove the references to SFAR 

No. 106, to ensure that the requirements 

of part 382 are consistent with the new 

acceptance criteria and labeling 

requirements set forth by the FAA in 

this rule, and to ensure the continued 

use of the POCs previously approved 

under SFAR No. 106, as permitted by 

the FAA. 

When amending regulations, the 

Administrative Procedure Act (APA) 

generally requires agencies to publish a 

notice of proposed rulemaking and give 

interested persons an opportunity to 

comment. However, the APA authorizes 

agencies to dispense with notice and 

comment if the agency finds for good 

cause that notice and public comment 

thereon are impracticable, unnecessary, 

or contrary to the public interest. 5 

U.S.C. 553(b)(3)(B). ‘‘Good cause’’ exists 

in situations in which notice 

unavoidably prevents the due and 

required execution of agency functions 

or when an agency finds that due and 

timely execution of its functions is 

impeded by the notice otherwise 

required by the APA. 

In this case, the agency finds that 

there is good cause to conclude that 

providing notice and public comment 

for the Department’s conforming 

amendments is unnecessary, 

impracticable and contrary to the public 

interest. Notice and public comment are 

impracticable because they would cause 

undue delay. Providing additional 

notice and comment would be 

impracticable and contrary to the public 

interest because during the delay caused 

by providing notice and public 

comment, the Department’s disability 

regulations would be inconsistent with 

FAA regulations. This could potentially 

cause confusion and affect disabled 

individuals’ ability to bring necessary 

medical devices on flights. 

Notice and comment on these 

conforming amendments is also 

unnecessary because the public has 

already had an opportunity to comment 

on the substantive issues addressed by 

this rulemaking. The Department is 

making minor amendments to part 382 

that simply conform the Department’s 

disability regulations to the FAA’s 

safety regulations. The Department does 

not believe that it would receive new 

substantive comments, in addition to 

those already received and addressed in 

this document, if it sought comment on 

the conforming amendments. For these 

reasons the Department has determined 

that the notice and comment rulemaking 

process is unnecessary, impracticable, 

and contrary to the public interest for 

these conforming amendments. 

1. Mandatory Acceptance of POCs That 

Meet FAA Acceptance Criteria 

In 2008, DOT amended part 382 to 

include a provision requiring covered 

carriers to permit a passenger with a 

disability to use an SFAR-approved POC 

on all covered flights. More specifically, 

part 382 requires U.S. carriers to permit 

an individual with a disability to use an 

SFAR-approved POC, a ventilator, a 

respirator, or a continuous positive 

airway pressure machine (CPAP 

machine) on all flights unless the device 

does not meet applicable FAA 

requirements for medical portable 

electronic devices and does not display 

a manufacturer’s label that indicates the 

device meets those FAA requirements. 

See 14 CFR 382.133(a). Foreign carriers 

must permit individuals with a 

disability to use a POC of a kind 

equivalent to a SFAR- approved POC, a 

ventilator, a respirator, or a CPAP 

machine for use on U.S. carriers in the 

passenger cabin on all covered flights 

unless the device does not meet the 

requirements for medical portable 

electronic devices set by the foreign 

carrier’s government if such 

requirements exist and/or the POC does 

not display a manufacturer’s label that 

indicates the device meets those 

requirements. See 14 CFR 382.133(b). 

In 2009, because the SFAR-approved 

POCs were not required to have labels 

under the FAA’s regulations, DOT 

issued guidance encouraging carriers to 

allow passengers to use these approved 

POCs even if the device had not been 

labeled, although carriers were not 

legally obligated to do so.18 Since then, 

airlines have largely implemented a 

policy to allow passengers to use SFARapproved POCs even if they do not have 

labels. 

In this final rule, the Department is 

amending its disability regulation to 

ensure that, consistent with the FAA’s 

actions in this rule, passengers with 

SFAR-approved POCs continue to be 

permitted to use these devices on 

aircraft, regardless of whether they are 

labeled, and that passengers with other 

POCs that satisfy the FAA acceptance 

criteria and labeling requirements will 

be able to use those POCs on their 

flights. As the FAA’s regulations are 

enabling rules, these changes in the 

Department’s disability regulation 

require carriers covered by part 382 to 

accept these POCs for air travel. 

2. Other Amendments to 14 CFR Part 

382 

The Department is revising 

§ 382.133(c)(3) (redesignated as 

§ 382.133(e)(3)) by eliminating the 

reference to SFAR No. 106 with respect 

to the packaging and protection of spare 

batteries carried in an aircraft cabin, as 

this final rule removes the SFAR from 

the CFR. Instead, the Department is 

referring directly to the applicable 

PHMSA requirements. 

The Department is also revising 

§ 382.133(c)(6) (redesignated as 

§ 382.133(e)(6) in this final rule) by 

eliminating the reference to federal 

aviation regulations with respect to the 

physicians statement, as in this final 

rule the FAA eliminates the SFAR No. 

106 requirement for a physician’s 

statement. The Department, however, is 

retaining the reference to 

§ 382.23(b)(1)(ii) that permits carriers to 

require a medical certificate from 

passengers who need medical oxygen 

during a flight. In that regard, there is 

also no change to our rules that permit 

a U.S. carrier or a foreign carrier to 

ensure that the passengers traveling 

with POCs have sufficient numbers of 

spare batteries to power the POC for up 

to 150% of the maximum flight 

duration. 

V. Regulatory Notices and Analyses 

A. Regulatory Evaluation 

Changes to Federal regulations must 

undergo several economic analyses. 

First, Executive Order 12866 and 

Executive Order 13563 direct that each 

Federal agency shall propose or adopt a 

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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. We 

suggest readers seeking greater detail 

read the full regulatory evaluation, a 

copy of which we have placed in the 

docket for this rulemaking. 

In conducting these analyses, FAA 

has determined that this final rule: (1) 

Has benefits that justify its costs, (2) is 

not an economically ‘‘significant 

regulatory action’’ as defined in section 

3(f) of Executive Order 12866, (3) is not 

‘‘significant’’ as defined in DOT’s 

Regulatory Policies and Procedures; (4) 

will not have a significant economic 

impact on a substantial number of small 

entities; (5) will not create unnecessary 

obstacles to the foreign commerce of the 

United States; and (6) will not impose 

an unfunded mandate on state, local, or 

tribal governments, or on the private 

sector by exceeding the threshold 

identified above. These analyses are 

summarized below. 

Total Benefits and Costs of This Rule 

The total cost savings from this final 

rule is $39.5 million ($27.6 million at 

7% present value and $33.6 million at 

3% present value). The largest cost 

savings of $39 million occurs from the 

reduction of crew time to review the 

physician’s statement. 

The FAA estimated that POC 

manufacturers that are expected to 

market POCs for use on aircraft will 

save a total of $108,000 over the ten year 

analysis period because the FAA will no 

longer require POC models to be 

identified in SFAR No. 106 prior to their 

use on aircraft. As a result of this action, 

POC manufacturers will no longer incur 

the administrative costs of petitioning 

the FAA which the FAA estimated 

would be $108,000. Further, because the 

manufacturer will no longer have to 

await resolution of that petition in order 

for a POC to be permitted for use on 

aircraft they will be able to introduce 

these devices sooner to the market. 

The FAA estimates that the cost of 

this final rule will be a one-time total 

cost of $22,000 incurred by all those 

POC manufacturers who comply with 

this final rule to modify a label and the 

associated costs that manufacturers will 

incur to change their current labeling 

process to affix a label with the language 

on the devices. 

Assumptions: 

• Present Value Discount rates—7% 

and 3% 

• Period of Analysis—ten years 

• 24 new POCs over ten years 

Entities Potentially Affected by This 

Rule: 

• POC manufacturers 

• Passengers carrying POCs on board 

aircraft 

• Physicians providing written 

statements to POC users 

• Aircraft operators (including 

crewmembers) 

Benefits of this Rule 

The replacement of the SFAR No. 106 

device approval process with a process 

by which POC manufacturers label 

those devices that satisfy FAA 

acceptance criteria, will shorten the 

time for manufacturers to begin selling 

new POC models that can be used on 

aircraft. Therefore, one benefit of this 

rule will be to eliminate delays and 

enable manufacturers to bring their 

devices to market sooner. Further the 

FAA estimates total industry cost 

savings of $108,000 because 

manufacturers will no longer incur the 

administrative costs of petitioning the 

FAA for each new device. These cost 

savings easily exceed the labeling costs. 

Furthermore, this final rule will result 

in cost savings because POC-using 

passengers will no longer have to obtain 

a physician’s written statement as a 

prerequisite to bringing POCs on board 

aircraft in parts 121, 125, and 135 

operations. 

The largest cost-savings will accrue to 

airline crews as there will no longer be 

a requirement for the crew to review the 

contents of the physician’s statement 

and to notify the pilot in command 

about the contents of the physician’s 

statement and the intention of the 

passenger to use the POC on board. 

The quantified cost savings of this 

final rule are summarized in table 4. 

TABLE 4—TOTAL ESTIMATED COST SAVINGS FROM FINAL RULE

Cost 

savings 

7% present 

value savings 

3% present 

value savings 

FAA Savings—No SFAR ............................................................................................................. $91,644 $68,871 $80,519 

Manufacturer Savings—No petition for rulemaking ..................................................................... 108,000 75,853 92,126 

Removal of FAA requirement for user to obtain a physician’s statement for POC use on aircraft .......................................................................................................................................... 569,961 401,645 486,914 

Removal of FAA requirement for crew review of physician’s statement and PIC notification .... 38,726,085 27,083,677 32,972,652 

Total Cost Savings ............................................................................................................... $39,495,690 $27,630,045 $33,632,212 

The FAA also identified another 

benefit that it did not quantify. This 

benefit comes from the use of a 

performance-based RF emissions 

acceptance criterion. Currently the 

manufacturers provide radiated RF 

emissions tests results showing that the 

device does not exceed thresholds 

established in Section 21 Category M of 

RTCA DO–160 to the FAA which posts 

these results on its Web site for aircraft 

operators to access. This final rule will 

include a performance-based RF 

emissions acceptance criterion that 

allows POC manufacturers to determine 

how to assess whether their POC meets 

the RF emissions limits for use on 

aircraft before they affix a label to the 

device confirming that this criterion has 

been satisfied. This might save 

manufacturers some cost if they can 

demonstrate in a less expensive way 

that their device meets the RF emissions 

criteria and will not degrade safety as 

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19A sixth manufacturer that was contacted 

estimated costs of $10,200, but this manufacturer is 

not a small business. 20http://www.manta.com/. 

the alternative method is an equivalent 

level of safety to the RTCA standard. 

Costs of This Rule 

As estimated in the NPRM, the FAA 

expects that POC manufacturers will 

incur costs of $22,000 to modify labels 

that they already affix to the POC, to 

contain the language required by this 

rule. 

B. 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 

factual basis for this determination, and 

the reasoning should be clear. 

This final rule is expected to reduce 

SFAR No. 106 requirements that 

currently result in a burden on POC 

manufacturers who produce POC 

devices for use on aircraft. This final 

rule will also result in small costs to 

manufacturers by requiring POCs 

intended for use on aircraft to bear a 

label indicating the device meets FAA 

requirements for use on board aircraft. 

The FAA learned from five of the small 

POC manufacturers that they might 

incur a one-time cost ranging from $200 

to $1,500 which averages $0.20 to $1 per 

label.19 These costs will be offset by cost 

savings because manufacturers will no 

longer have to petition for rulemaking 

and lose marketing time awaiting a final 

regulatory action. One manufacturer 

stated these cost savings are worth 

$4,500 for each petition. 

The FAA identified nine companies 

that produce POCs intended for use on 

board aircraft. The FAA determined that 

the appropriate North American 

Industry Classification System (NAICS) 

codes of these manufacturers are 339112 

and 339113 and the threshold for 

determining whether a company is a 

small business is 500 employees for 

those industries. Through online 

research, the FAA found data 20

indicating that six of the nine 

manufacturers are small entities and 

concluded that a substantial number of 

manufacturers are small entities. 

However, the FAA does not expect the 

rule to impose a significant economic 

impact on any of these small entities 

because the estimated cost savings of no 

longer having to petition the FAA 

(estimated at $4,500 per manufacturer) 

exceed the estimated costs of modifying 

the label (estimated at $2,400 per 

manufacturer) to comply with this final 

rule. Also, there is a benefit to POC 

manufacturers, in that the 

manufacturers will receive revenue 

sooner because they will be able to 

market new portable oxygen 

concentrators sooner. 

Although a substantial number of 

operators conducting parts 121, 125 and 

135 operations are small entities, all 

parts 121, 125 and 135 operators are 

expected to experience cost savings 

because the proposal will no longer 

require the PIC to be apprised when a 

passenger brings and intends to use a 

POC on board the aircraft and be 

informed on the contents of the 

physician’s statement as does SFAR No. 

106. The FAA did not receive comments 

on the initial regulatory flexibility 

analysis where we first discussed these 

cost savings. Therefore, as provided in 

section 605(b), the head of the FAA 

certifies that this rulemaking will not 

result in a significant economic impact 

on a substantial number of small 

entities. 

C. 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 as 

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 no effect 

on international trade. 

D. 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 

$155.0 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. 

E. Paperwork Reduction Act 

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. The 

FAA has determined that there is no 

new requirement for information 

collection associated with this final 

rule. 

F. International Compatibility and 

Cooperation 

In keeping with U.S. obligations 

under the Convention on International 

Civil Aviation, it is FAA policy to 

conform to ICAO Standards and 

Recommended Practices to the 

maximum extent practicable. Annex 18 

to the Convention on International Civil 

Aviation requires that dangerous goods 

are carried in accordance with the ICAO 

Technical Instructions on the Transport 

of Dangerous Goods by Air. The ICAO 

Technical Instructions do not contain 

specific provisions for POCs but Part 8 

of the ICAO Technical Instructions 

(passenger and crew exceptions) allows 

for their carriage on board aircraft as 

portable medical electronic devices 

subject to certain conditions. Although 

the format is different, the conditions in 

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Part 8 pertaining to batteries used to 

power POCs are the same as the 

allowances given in 49 CFR 

175.10(a)(18). 

G. Environmental Analysis 

FAA Order 1050.1F 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 5–6.6 and involves no 

extraordinary circumstances. 

VI. Executive Order Determinations 

A. Executive Order 13132, Federalism 

The FAA has analyzed this 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. 

B. Executive Order 13211, Regulations 

That Significantly Affect Energy Supply, 

Distribution, or Use 

The FAA analyzed this 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. 

VII. How To Obtain Additional 

Information 

A. Rulemaking Documents 

An electronic copy of a rulemaking 

document may 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 Publishing 

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) 267–9677. 

B. Comments Submitted to the Docket 

Comments received may be viewed by 

going to http://www.regulations.gov and 

following the online instructions to 

search the docket number for this 

action. Anyone is able to search the 

electronic form of all comments 

received into any of the FAA’s 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.). 

C. 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://

www.faa.gov/regulations_policies/

rulemaking/sbre_act/. 

List of Subjects 

14 CFR Part 1 

Air transportation. 

14 CFR Part 11 

Reporting and recordkeeping 

requirements. 

14 CFR Part 121 

Air carriers, Aircraft, Aviation safety, 

Charter flights, Safety, Transportation. 

14 CFR Part 125 

Aircraft, Aviation safety. 

14 CFR Part 135 

Air taxis, Aircraft, Aviation safety. 

14 CFR Part 382 

Air Carriers, Consumer protection, 

Individuals with disabilities. 

The Amendment 

In consideration of the foregoing, the 

Federal Aviation Administration and 

the Office of the Secretary amend 

chapters I and II of title 14, Code of 

Federal Regulations as follows: 

PART 1—DEFINITIONS AND 

ABBREVIATIONS 

■ 1. The authority citation for part 1 

continues to read as follows: 

Authority: 49 U.S.C. 106(f), 106(g), 40113, 

44701. 

■ 2. Amend § 1.1 by adding a definition 

for ‘‘portable oxygen concentrator’’ in 

alphabetical order to read as follows: 

§ 1.1 General definitions. 

* * * * * 

Portable oxygen concentrator means a 

medical device that separates oxygen 

from other gasses in ambient air and 

dispenses this concentrated oxygen to 

the user. 

* * * * * 

■ 3. Amend § 1.2 by adding the 

abbreviation ‘‘POC’’ in alphabetical 

order to read as follows: 

§ 1.2 Abbreviations 

* * * * * 

POC means portable oxygen 

concentrator. 

* * * * * 

PART 11—GENERAL RULEMAKING 

PROCEDURES 

■ 4. The authority citation for part 11 

continues to read as follows: 

Authority: 49 U.S.C. 106(f), 106(g), 40101, 

40103, 40105, 40109, 40113, 44110, 44502, 

44701–44702, 44711, and 46102. 

■ 5. In § 11.201, amend the table in 

paragraph (b) by revising the entry for 

part 121 to read as follows: 

§ 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, 2120–0739, 2120–0760, 2120–0766. 

* * * * * * * 

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PART 121—OPERATING 

REQUIREMENTS: DOMESTIC, FLAG, 

AND SUPPLEMENTAL OPERATIONS 

■ 6. The authority citation for part 121 

continues to read as follows: 

Authority: 49 U.S.C. 106(f), 106(g), 40103, 

40113, 40119, 41706, 42301 preceding note 

added by Public Law 112–95, sec. 412, 126 

Stat. 89, 44101, 44701–44702, 44705, 44709– 

44711, 44713, 44716–44717, 44722, 44729, 

44732, 46105; Public Law 111–216, 124 Stat. 

2348 (49 U.S.C. 44701 note); Public Law 112– 

95, 126 Stat. 62 (49 U.S.C. 44732 note). 

Special Federal Aviation Regulation 

No. 106 [Removed] 

■ 7. Remove Special Federal Aviation 

Regulation No. 106. 

■ 8. Amend § 121.306 as follows: 

■ a. In paragraph (b)(4), remove ‘‘or’’ 

following the semicolon; 

■ b. Redesignate paragraph (b)(5) as 

paragraph (b)(6); 

■ c. Add new paragraph (b)(5); and 

■ d. In paragraph (c), remove the 

reference ‘‘(b)(5)’’ and add in its place 

‘‘(b)(6)’’. 

The addition reads as follows: 

§ 121.306 Portable electronic devices. 

* * * * * 

(b)* * * 

(5) Portable oxygen concentrators that 

comply with the requirements in 

§ 121.574; or 

* * * * * 

■ 9. Amend § 121.574 as follows: 

■ a. Revise the section heading; 

■ b. Revise paragraph (a) introductory 

text; 

■ c. In paragraph (a)(3), remove the 

reference ‘‘49 CFR 173.300(a)’’ and add 

in its place ‘‘49 CFR 173.115(b)’’; 

■ d. Revise paragraph (b); and 

■ e. Add paragraph (e). 

The revisions and addition read as 

follows: 

§ 121.574 Oxygen and portable oxygen 

concentrators for medical use by 

passengers. 

(a) A certificate holder may allow a 

passenger to carry and operate 

equipment for the storage, generation, or 

dispensing of oxygen when all of the 

conditions in paragraphs (a) through (d) 

of this section are satisfied. Beginning 

August 22, 2016, a certificate holder 

may allow a passenger to carry and 

operate a portable oxygen concentrator 

when the conditions in paragraphs (b) 

and (e) of this section are satisfied. 

* * * * * 

(b) No person may smoke or create an 

open flame and no certificate holder 

may allow any person to smoke or 

create an open flame within 10 feet of 

oxygen storage and dispensing 

equipment carried in accordance with 

paragraph (a) of this section or a 

portable oxygen concentrator carried 

and operated in accordance with 

paragraph (e) of this section. 

* * * * * 

(e) Portable oxygen concentrators—(1) 

Acceptance criteria. A passenger may 

carry or operate a portable oxygen 

concentrator for personal use on board 

an aircraft and a certificate holder may 

allow a passenger to carry or operate a 

portable oxygen concentrator on board 

an aircraft operated under this part 

during all phases of flight if the portable 

oxygen concentrator satisfies all of the 

requirements in this paragraph (e): 

(i) Is legally marketed in the United 

States in accordance with Food and 

Drug Administration requirements in 

title 21 of the CFR; 

(ii) Does not radiate radio frequency 

emissions that interfere with aircraft 

systems; 

(iii) Generates a maximum oxygen 

pressure of less than 200 kPa gauge 

(29.0 psig/43.8 psia) at 20 °C (68 °F); 

(iv) Does not contain any hazardous 

materials subject to the Hazardous 

Materials Regulations (49 CFR parts 171 

through 180) except as provided in 49 

CFR 175.10 for batteries used to power 

portable electronic devices and that do 

not require aircraft operator approval; 

and 

(v) Bears a label on the exterior of the 

device applied in a manner that ensures 

the label will remain affixed for the life 

of the device and containing the 

following certification statement in red 

lettering: ‘‘The manufacturer of this POC 

has determined this device conforms to 

all applicable FAA acceptance criteria 

for POC carriage and use on board 

aircraft.’’ The label requirements in this 

paragraph (e)(1)(v) do not apply to the 

following portable oxygen concentrators 

approved by the FAA for use on board 

aircraft prior to May 24, 2016: 

(A) AirSep Focus; 

(B) AirSep FreeStyle; 

(C) AirSep FreeStyle 5; 

(D) AirSep LifeStyle; 

(E) Delphi RS–00400; 

(F) DeVilbiss Healthcare iGo; 

(G) Inogen One; 

(H) Inogen One G2; 

(I) Inogen One G3; 

(J) Inova Labs LifeChoice; 

(K) Inova Labs LifeChoice Activox; 

(L) International Biophysics 

LifeChoice; 

(M) Invacare Solo2; 

(N) Invacare XPO2; 

(O) Oxlife Independence Oxygen 

Concentrator; 

(P) Oxus RS–00400; 

(Q) Precision Medical EasyPulse; 

(R) Respironics EverGo; 

(S) Respironics SimplyGo; 

(T) SeQual Eclipse; 

(U) SeQual eQuinox Oxygen System 

(model 4000); 

(V) SeQual Oxywell Oxygen System 

(model 4000); 

(W) SeQual SAROS; and 

(X) VBox Trooper Oxygen 

Concentrator. 

(2) Operating requirements. Portable 

oxygen concentrators that satisfy the 

acceptance criteria identified in 

paragraph (e)(1) of this section may be 

carried or operated by a passenger on an 

aircraft provided the aircraft operator 

ensures that all of the conditions in this 

paragraph (e)(2) are satisfied: 

(i) Exit seats. No person operating a 

portable oxygen concentrator is 

permitted to occupy an exit seat. 

(ii) Stowage of device. During 

movement on the surface, takeoff and 

landing, the device must 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 to the row. If the device 

is to be operated by the user, it must be 

operated 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. 

PART 125—CERTIFICATION AND 

OPERATIONS: AIRPLANES HAVING A 

SEATING CAPACITY OF 20 OR MORE 

PASSENGERS OR A MAXIMUM 

PAYLOAD CAPACITY OF 6,000 

POUNDS OR MORE; AND RULES 

GOVERNING PERSONS ON BOARD 

SUCH AIRCRAFT 

■ 10. The authority citation for part 125 

continues to read as follows: 

Authority: 49 U.S.C. 106(f), 106(g), 40113, 

44701–44702, 44705, 44710–44711, 44713, 

44716–44717, 44722. 

Special Federal Aviation Regulation 

No. 106 [Removed] 

■ 11. Remove Special Federal Aviation 

Regulation No. 106. 

■ 12. Amend § 125.204 as follows: 

■ a. In paragraph (b)(4), remove ‘‘or’’ 

following the semicolon; 

■ b. Redesignate paragraph (b)(5) as 

paragraph (b)(6); 

■ c. Add new paragraph (b)(5); and 

■ d. In paragraph (c), remove the 

reference ‘‘(b)(5)’’ and add in its place 

‘‘(b)(6)’’. 

The addition reads as follows: 

§ 125.204 Portable electronic devices. 

* * * * * 

(b) * * * 

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Federal Register / Vol. 81, No. 100 / Tuesday, May 24, 2016 / Rules and Regulations 33119 

(5) Portable oxygen concentrators that 

comply with the requirements in 

§ 125.219; or 

* * * * * 

■ 13. Amend § 125.219 as follows: 

■ a. Revise the section heading; 

■ b. Revise paragraph (a) introductory 

text; 

■ c. In paragraph (a)(1)(iii), after the 

semicolon, remove ‘‘and’’; 

■ d. Redesignate paragraph (a)(1)(iv) as 

paragraph (a)(1)(v); 

■ e. Add new paragraph (a)(1)(iv); 

■ f. In paragraph (a)(3), remove the 

reference ‘‘title 49 CFR 173.300(a)’’ and 

add in its place ‘‘49 CFR 173.115(b)’’; 

■ g. Revise paragraph (b); and 

■ h. Add paragraph (f). 

The revisions and additions read as 

follows: 

§ 125.219 Oxygen and portable oxygen 

concentrators for medical use by 

passengers. 

(a) Except as provided in paragraphs 

(d) and (f) of this section, no certificate 

holder may allow the carriage or 

operation of equipment for the storage, 

generation or dispensing of medical 

oxygen unless the conditions in 

paragraphs (a) through (c) of this section 

are satisfied. Beginning August 22, 

2016, a certificate holder may allow a 

passenger to carry and operate a 

portable oxygen concentrator when the 

conditions in paragraphs (b) and (f) of 

this section are satisfied. 

(1) * * * 

(iv) Constructed so that all valves, 

fittings, and gauges are protected from 

damage during that carriage or 

operation; and 

* * * * * 

(b) No person may smoke or create an 

open flame and no certificate holder 

may allow any person to smoke or 

create an open flame within 10 feet of 

oxygen storage and dispensing 

equipment carried under paragraph (a) 

of this section or a portable oxygen 

concentrator carried and operated under 

paragraph (f) of this section. 

* * * * * 

(f) Portable oxygen concentrators—(1) 

Acceptance criteria. A passenger may 

carry or operate a portable oxygen 

concentrator for personal use on board 

an aircraft and a certificate holder may 

allow a passenger to carry or operate a 

portable oxygen concentrator on board 

an aircraft operated under this part 

during all phases of flight if the portable 

oxygen concentrator satisfies all of the 

requirements in this paragraph (f): 

(i) Is legally marketed in the United 

States in accordance with Food and 

Drug Administration requirements in 

title 21 of the CFR; 

(ii) Does not radiate radio frequency 

emissions that interfere with aircraft 

systems; 

(iii) Generates a maximum oxygen 

pressure of less than 200 kPa gauge 

(29.0 psig/43.8 psia) at 20 °C (68 °F); 

(iv) Does not contain any hazardous 

materials subject to the Hazardous 

Materials Regulations (49 CFR parts 171 

through 180) except as provided in 49 

CFR 175.10 for batteries used to power 

portable electronic devices and that do 

not require aircraft operator approval; 

and 

(v) Bears a label on the exterior of the 

device applied in a manner that ensures 

the label will remain affixed for the life 

of the device and containing the 

following certification statement in red 

lettering: ‘‘The manufacturer of this POC 

has determined this device conforms to 

all applicable FAA acceptance criteria 

for POC carriage and use on board 

aircraft.’’ The label requirements in this 

paragraph (f)(1)(v) do not apply to the 

following portable oxygen concentrators 

approved by the FAA for use on board 

aircraft prior to May 24, 2016: 

(A) AirSep Focus; 

(B) AirSep FreeStyle; 

(C) AirSep FreeStyle 5; 

(D) AirSep LifeStyle; 

(E) Delphi RS–00400; 

(F) DeVilbiss Healthcare iGo; 

(G) Inogen One; 

(H) Inogen One G2; 

(I) Inogen One G3; 

(J) Inova Labs LifeChoice; 

(K) Inova Labs LifeChoice Activox; 

(L) International Biophysics 

LifeChoice; 

(M) Invacare Solo2; 

(N) Invacare XPO2; 

(O) Oxlife Independence Oxygen 

Concentrator; 

(P) Oxus RS–00400; 

(Q) Precision Medical EasyPulse; 

(R) Respironics EverGo; 

(S) Respironics SimplyGo; 

(T) SeQual Eclipse; 

(U) SeQual eQuinox Oxygen System 

(model 4000); 

(V) SeQual Oxywell Oxygen System 

(model 4000); 

(W) SeQual SAROS; and 

(X) VBox Trooper Oxygen 

Concentrator. 

(2) Operating requirements. Portable 

oxygen concentrators that satisfy the 

acceptance criteria identified in 

paragraph (f)(1) of this section may be 

carried or used by a passenger on an 

aircraft provided the aircraft operator 

ensures that all of the conditions in this 

paragraph (f)(2) are satisfied: 

(i) Exit seats. No person operating a 

portable oxygen concentrator is 

permitted to occupy an exit seat. 

(ii) Stowage of device. During 

movement on the surface, takeoff and 

landing, the device must 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 to the row. If the device 

is to be operated by the user, it must be 

operated 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. 

PART 135—OPERATING 

REQUIREMENTS: COMMUTER AND 

ON DEMAND OPERATIONS AND 

RULES GOVERNING PERSONS ON 

BOARD SUCH AIRCRAFT 

■ 14. The authority citation for part 135 

continues to read as follows: 

Authority: 49 U.S.C. 106(f), 106(g), 41706, 

40113, 44701–44702, 44705, 44709, 44711– 

44713, 44715–44717, 44722, 44730, 45101– 

45105; Public Law 112–95, 126 Stat. 58 (49 

U.S.C. 44730). 

Special Federal Aviation Regulation 

No. 106 [Removed] 

■ 15. Remove Special Federal Aviation 

Regulation No. 106. 

■ 16. Amend § 135.91 as follows: 

■ a. Revise the section heading and 

paragraph (a) introductory text; 

■ b. In paragraph (a)(1)(iii), after the 

semicolon, remove ‘‘and’’; 

■ c. Redesignate paragraph (a)(1)(iv) as 

paragraph (a)(1)(v); 

■ d. Add new paragraph (a)(1)(iv); 

■ e. In paragraph (a)(3), remove the 

reference ‘‘title 49 CFR 173.300(a)’’ and 

add in its place ‘‘49 CFR 173.115(b)’’; 

■ f. Revise paragraph (b); and 

■ g. Add paragraph (f). 

The revisions and additions read as 

follows: 

§ 135.91 Oxygen and portable oxygen 

concentrators for medical use by 

passengers. 

(a) Except as provided in paragraphs 

(d) and (e) of this section, no certificate 

holder may allow the carriage or 

operation of equipment for the storage, 

generation or dispensing of medical 

oxygen unless the conditions in 

paragraphs (a) through (c) of this section 

are satisfied. Beginning August 22, 

2016, a certificate holder may allow a 

passenger to carry and operate a 

portable oxygen concentrator when the 

conditions in paragraphs (b) and (f) of 

this section are satisfied. 

(1) * * * 

(iv) Constructed so that all valves, 

fittings, and gauges are protected from 

damage during carriage or operation; 

and 

* * * * * 

(b) No person may smoke or create an 

open flame and no certificate holder 

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33120 Federal Register / Vol. 81, No. 100 / Tuesday, May 24, 2016 / Rules and Regulations 

may allow any person to smoke or 

create an open flame within 10 feet of 

oxygen storage and dispensing 

equipment carried under paragraph (a) 

of this section or a portable oxygen 

concentrator carried and operated under 

paragraph (f) of this section. 

* * * * * 

(f) Portable oxygen concentrators—(1) 

Acceptance criteria. A passenger may 

carry or operate a portable oxygen 

concentrator for personal use on board 

an aircraft and a certificate holder may 

allow a passenger to carry or operate a 

portable oxygen concentrator on board 

an aircraft operated under this part 

during all phases of flight if the portable 

oxygen concentrator satisfies all of the 

requirements of this paragraph (f): 

(i) Is legally marketed in the United 

States in accordance with Food and 

Drug Administration requirements in 

title 21 of the CFR; 

(ii) Does not radiate radio frequency 

emissions that interfere with aircraft 

systems; 

(iii) Generates a maximum oxygen 

pressure of less than 200 kPa gauge 

(29.0 psig/43.8 psia) at 20 °C (68 °F); 

(iv) Does not contain any hazardous 

materials subject to the Hazardous 

Materials Regulations (49 CFR parts 171 

through 180) except as provided in 49 

CFR 175.10 for batteries used to power 

portable electronic devices and that do 

not require aircraft operator approval; 

and 

(v) Bears a label on the exterior of the 

device applied in a manner that ensures 

the label will remain affixed for the life 

of the device and containing the 

following certification statement in red 

lettering: ‘‘The manufacturer of this POC 

has determined this device conforms to 

all applicable FAA acceptance criteria 

for POC carriage and use on board 

aircraft.’’ The label requirements in this 

paragraph (f)(1)(v) do not apply to the 

following portable oxygen concentrators 

approved by the FAA for use on board 

aircraft prior to May 24, 2016: 

(A) AirSep Focus; 

(B) AirSep FreeStyle; 

(C) AirSep FreeStyle 5; 

(D) AirSep LifeStyle; 

(E) Delphi RS–00400; 

(F) DeVilbiss Healthcare iGo; 

(G) Inogen One; 

(H) Inogen One G2; 

(I) Inogen One G3; 

(J) Inova Labs LifeChoice; 

(K) Inova Labs LifeChoice Activox; 

(L) International Biophysics 

LifeChoice; 

(M) Invacare Solo2; 

(N) Invacare XPO2; 

(O) Oxlife Independence Oxygen 

Concentrator; 

(P) Oxus RS–00400; 

(Q) Precision Medical EasyPulse; 

(R) Respironics EverGo; 

(S) Respironics SimplyGo; 

(T) SeQual Eclipse; 

(U) SeQual eQuinox Oxygen System 

(model 4000); 

(V) SeQual Oxywell Oxygen System 

(model 4000); 

(W) SeQual SAROS; and 

(X) VBox Trooper Oxygen 

Concentrator. 

(2) Operating requirements. Portable 

oxygen concentrators that satisfy the 

acceptance criteria identified in 

paragraph (f)(1) of this section may be 

carried on or operated by a passenger on 

board an aircraft provided the aircraft 

operator ensures that all of the 

conditions in this paragraph (f)(2) are 

satisfied: 

(i) Exit seats. No person operating a 

portable oxygen concentrator is 

permitted to occupy an exit seat. 

(ii) Stowage of device. During 

movement on the surface, takeoff and 

landing, the device must 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 to the row. If the device 

is to be operated by the user, it must be 

operated 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. 

■ 17. Amend § 135.144 as follows: 

■ a. In paragraph (a) introductory text, 

remove ‘‘of the following’’; 

■ b. In paragraph (b)(4), remove ‘‘or’’ 

following the semicolon; 

■ c. Redesignate paragraph (b)(5) as 

paragraph (b)(6); 

■ d. Add new paragraph (b)(5); and 

■ e. In paragraph (c), remove the 

reference ‘‘(b)(5)’’ and add in its place 

‘‘(b)(6)’’. 

The addition reads as follows: 

§ 135.144 Portable electronic devices. 

* * * * * 

(b) * * * 

(5) Portable oxygen concentrators that 

comply with the requirements in 

§ 135.91; or 

* * * * * 

PART 382—NONDISCRIMINATION ON 

THE BASIS OF DISABILITY IN AIR 

TRAVEL 

■ 18. The authority citation for part 382 

continues to read as follows: 

Authority: 49 U.S.C. 41705. 

■ 19. In § 382.27, revise paragraph (a) to 

read as follows: 

§ 382.27 May a carrier require a passenger 

with a disability to provide advance notice 

in order to obtain certain specific services 

in connection with a flight? 

(a) Except as provided in paragraph 

(b) of this section and § 382.133(e)(4) 

and (5) and (f)(5) and (6), as a carrier 

you must not require a passenger with 

a disability to provide advance notice in 

order to obtain services or 

accommodations required by this part. 

* * * * * 

■ 20. Revise § 382.133 to read as 

follows: 

§ 382.133 What are the requirements 

concerning the evaluation and use of 

passenger-supplied electronic devices that 

assist passengers with respiration in the 

cabin during flight? 

(a) Except for on-demand air taxi 

operators, as a U.S. carrier conducting 

passenger service you must permit any 

individual with a disability to use in the 

passenger cabin during air 

transportation an electronic assistive 

device specified in paragraph (c) of this 

section on all aircraft originally 

designed to have a maximum passenger 

capacity of more than 19 seats unless: 

(1) The device does not meet 

applicable FAA requirements for 

medical portable electronic device; or 

(2) The device cannot be stowed and 

used in the passenger cabin consistent 

with applicable TSA, FAA, and PHMSA 

regulations. 

(b) Except for foreign carriers 

conducting operations of a nature 

equivalent to on-demand air taxi 

operations by a U.S. carrier, as a foreign 

carrier conducting passenger service 

you must permit any individual with a 

disability to use in the passenger cabin 

during air transportation to, from or 

within the United States, an electronic 

assistive device specified in paragraph 

(d) of this section on all aircraft 

originally designed to have a maximum 

passenger capacity of more than 19 seats 

unless: 

(1) The device does not meet 

requirements for medical portable 

electronic devices set by the foreign 

carrier’s government if such 

requirements exist; 

(2) The device does not meet 

requirements for medical portable 

electronic devices set by the FAA for 

U.S. carriers in circumstances where 

requirements for medical portable 

electronic devices have not been set by 

the foreign carrier’s government and the 

foreign carrier elects to apply FAA 

requirements for medical portable 

electronic devices; or 

(3) The device cannot be stowed and 

used in the passenger cabin consistent 

with applicable TSA, FAA and PHMSA 

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Federal Register / Vol. 81, No. 100 / Tuesday, May 24, 2016 / Rules and Regulations 33121 

regulations, and the safety or security 

regulations of the foreign carrier’s 

government. 

(c) Except as provided in paragraph 

(a) of this section, as a covered U.S. air 

carrier, you must accept the passenger 

supplied electronic assistive device in 

this paragraph (c): 

(1) A portable oxygen concentrator 

(POC), a ventilator, a respirator or a 

continuous positive airway pressure 

machine that displays a manufacturer’s 

label that indicates the device meets 

FAA requirements; and 

(2) The following POC models 

whether or not they are labeled: 

(i) AirSep Focus; 

(ii) AirSep FreeStyle; 

(iii) AirSep FreeStyle 5; 

(iv) AirSep LifeStyle; 

(v) Delphi RS–00400; 

(vi) DeVilbiss Healthcare iGo; 

(vii) Inogen One; 

(viii) Inogen One G2; 

(ix) Inogen One G3; 

(x) Inova Labs LifeChoice; 

(xi) Inova Labs LifeChoice Activox; 

(xii) International Biophysics 

LifeChoice; 

(xiii) Invacare Solo2; 

(xiv) Invacare XPO2; 

(xv) Oxlife Independence Oxygen 

Concentrator; 

(xvi) Oxus RS–00400; 

(xvii) Precision Medical EasyPulse; 

(xviii) Respironics EverGo; 

(xix) Respironics SimplyGo; 

(xx) SeQual Eclipse; 

(xxi) SeQual eQuinox Oxygen System 

(model 4000); 

(xxii) SeQual Oxywell Oxygen System 

(model 4000); 

(xxiii) SeQual SAROS; and 

(xxiv) VBox Trooper Oxygen 

Concentrator. 

(d) Except as provided in paragraph 

(b) of this section, as a covered foreign 

air carrier, you must accept the supplied 

electronic assistive devices in this 

paragraph (d): 

(1) A POC, a ventilator, a respirator or 

a continuous positive airway pressure 

machine that displays a manufacturer’s 

label according to FAA requirements in 

circumstances where requirements for 

labeling these devices have not been set 

by the foreign carrier’s government; and 

(2) The following POC models 

whether or not they are labeled: 

(i) AirSep Focus; 

(ii) AirSep FreeStyle; 

(iii) AirSep FreeStyle 5; 

(iv) AirSep LifeStyle; 

(v) Delphi RS–00400; 

(vi) DeVilbiss Healthcare iGo; 

(vii) Inogen One; 

(viii) Inogen One G2; 

(ix) Inogen One G3; 

(x) Inova Labs LifeChoice; 

(xi) Inova Labs LifeChoice Activox; 

(xii) International Biophysics 

LifeChoice; 

(xiii) Invacare Solo2; 

(xiv) Invacare XPO2; 

(xv) Oxlife Independence Oxygen 

Concentrator; 

(xvi) Oxus RS–00400; 

(xvii) Precision Medical EasyPulse; 

(xviii) Respironics EverGo; 

(xix) Respironics SimplyGo; 

(xx) SeQual Eclipse; 

(xxi) SeQual eQuinox Oxygen System 

(model 4000); 

(xxii) SeQual Oxywell Oxygen System 

(model 4000); 

(xxiii) SeQual SAROS; and 

(xxiv) VBox Trooper Oxygen 

Concentrator. 

(e) As a U.S. carrier, you must provide 

information during the reservation 

process as indicated in paragraphs (e)(1) 

through (6) of this section upon inquiry 

from an individual concerning the use 

in the cabin during air transportation of 

a ventilator, respirator, continuous 

positive airway machine, or a POC. The 

information in this paragraph (e) must 

be provided: 

(1) Any applicable requirement for a 

manufacturer-affixed label to reflect that 

the device has been tested to meet 

applicable FAA requirements for 

medical portable electronic devices; 

(2) The maximum weight and 

dimensions (length, width, height) of 

the device to be used by an individual 

that can be accommodated in the 

aircraft cabin consistent with FAA 

safety requirements; 

(3) The requirement to bring an 

adequate number of batteries as outlined 

in paragraph (h)(2) of this section and to 

ensure that extra batteries carried 

onboard to power the device are 

packaged and protected from short 

circuit and physical damage in 

accordance with applicable PHMSA 

regulations regarding spare batteries 

carried by passengers in an aircraft 

cabin; 

(4) Any requirement, if applicable, 

that an individual contact the carrier 

operating the flight 48 hours before 

scheduled departure to learn the 

expected maximum duration of his/her 

flight in order to determine the required 

number of batteries for his/her 

particular ventilator, respirator, 

continuous positive airway pressure 

machine, or POC; 

(5) Any requirement, if applicable, of 

the carrier operating the flight for an 

individual planning to use such a 

device to check-in up to one hour before 

that carrier’s general check-in deadline; 

and 

(6) For POCs, the requirement of 

§ 382.23(b)(1)(ii) to present to the 

operating carrier at the airport a 

physician’s statement (medical 

certificate). 

(f) As a foreign carrier operating 

flights to, from or within the United 

States, you must provide the 

information during the reservation 

process as indicated in paragraphs (f)(1) 

through (7) of this section upon inquiry 

from an individual concerning the use 

in the cabin during air transportation on 

such a flight of a ventilator, respirator, 

continuous positive airway machine, or 

POC. The information in this paragraph 

(f) must be provided: 

(1) Any applicable requirement for a 

manufacturer-affixed label to reflect that 

the device has been tested to meet 

requirements for medical portable 

electronic devices set by the foreign 

carrier’s government if such 

requirements exist; 

(2) Any applicable requirement for a 

manufacturer-affixed label to reflect that 

the device has been tested to meet 

requirements for medical portable 

electronic devices set by the FAA for 

U.S. carriers if requirements for medical 

portable electronic devices have not 

been set by the foreign carrier’s 

government and the foreign carrier 

elects to apply FAA requirements for 

medical portable electronic devices; 

(3) The maximum weight and 

dimensions (length, width, height) of 

the device to be used by an individual 

that can be accommodated in the 

aircraft cabin consistent with the safety 

regulations of the foreign carrier’s 

government; 

(4) The requirement to bring an 

adequate number of batteries as outlined 

in paragraph (h)(2) of this section and to 

ensure that extra batteries carried 

onboard to power the device are 

packaged in accordance with applicable 

government safety regulations; 

(5) Any requirement, if applicable, 

that an individual contact the carrier 

operating the flight 48 hours before 

scheduled departure to learn the 

expected maximum duration of his/her 

flight in order to determine the required 

number of batteries for his/her 

particular ventilator, respirator, 

continuous positive airway pressure 

machine, or POC; 

(6) Any requirement, if applicable, of 

the carrier operating the flight for an 

individual planning to use such a 

device to check-in up to one hour before 

that carrier’s general check-in deadline; 

and 

(7) Any requirement, if applicable, 

that an individual who wishes to use a 

POC onboard an aircraft present to the 

operating carrier at the airport a 

physician’s statement (medical 

certificate). 

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33122 Federal Register / Vol. 81, No. 100 / Tuesday, May 24, 2016 / Rules and Regulations 

(g) In the case of a codeshare itinerary, 

the carrier whose code is used on the 

flight must either inform the individual 

inquiring about using a ventilator, 

respirator, CPAP machine or POC 

onboard an aircraft to contact the carrier 

operating the flight for information 

about its requirements for use of such 

devices in the cabin, or provide such 

information on behalf of the codeshare 

carrier operating the flight. 

(h)(1) As a U.S. or foreign carrier 

subject to paragraph (a) or (b) of this 

section, you must inform any individual 

who has advised you that he or she 

plans to operate his/her device in the 

aircraft cabin, within 48 hours of his/her 

making a reservation or 24 hours before 

the scheduled departure date of his/her 

flight, whichever date is earlier, of the 

expected maximum flight duration of 

each segment of his/her flight itinerary. 

(2) You may require an individual to 

bring an adequate number of fully 

charged batteries onboard, based on the 

battery manufacturer’s estimate of the 

hours of battery life while the device is 

in use and the information provided in 

the physician’s statement, to power the 

device for not less than 150% of the 

expected maximum flight duration. 

(3) If an individual does not comply 

with the conditions for acceptance of a 

medical portable electronic device as 

outlined in this section, you may deny 

boarding to the individual in 

accordance with § 382.19(c) and in that 

event you must provide a written 

explanation to the individual in 

accordance with § 382.19(d). 

Issued under authority provided by 49 

U.S.C. 106(f) and 44701(a), and authority 

provided by 49 U.S.C. 41705, delegated at 49 

CFR 1.27, in Washington, DC, on May 11, 

2016. 

Kathryn B. Thomson, 

General Counsel, Department of 

Transportation. 

Michael P. Huerta, 

Administrator, Federal Aviation 

Administration. 

[FR Doc. 2016–11918 Filed 5–23–16; 8:45 am] 

BILLING CODE 4910–13–P 

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