This section of the FEDERAL REGISTER

contains notices to the public of the proposed

issuance of rules and regulations. The

purpose of these notices is to give interested

persons an opportunity to participate in the

rule making prior to the adoption of the final

rules.

Proposed Rules Federal Register

56288 

Vol. 79, No. 182 

Friday, September 19, 2014 

DEPARTMENT OF TRANSPORTATION 

Federal Aviation Administration 

14 CFR Parts 1, 121, 125, and 135 

[Docket No.: FAA–2014–0554; Notice No. 

14–08] 

RIN 2120–AK32 

Acceptance Criteria for Portable 

Oxygen Concentrators Used On Board 

Aircraft 

AGENCY: Federal Aviation 

Administration (FAA), DOT. 

ACTION: Notice of proposed rulemaking 

(NPRM). 

SUMMARY: This rulemaking would 

replace Special Federal Aviation 

Regulation No. 106 with acceptance 

criteria for portable oxygen 

concentrators to be used by passengers 

in air carrier operations, commercial 

operations and certain other operations 

using large aircraft. Currently, the 

agency assesses each portable oxygen 

concentrator on a case-by-case basis to 

determine whether it is safe for use on 

board aircraft. If the agency determines 

that a portable oxygen concentrator is 

safe for use on board aircraft, the 

specific model is identified in 

regulations. This rulemaking would 

replace the burdensome approval 

process with acceptance criteria and a 

requirement for manufacturers to 

demonstrate compliance by affixing a 

label on the exterior of the portable 

oxygen concentrator applied in a 

manner that ensures it will remain 

affixed for the life of the device. The 

proposed acceptance criteria and 

labeling requirement would only affect 

portable oxygen concentrators intended 

for use on board aircraft. Portable 

oxygen concentrators currently 

approved for use on board aircraft 

would not be affected by this proposal 

and will be listed in this rule as 

approved. This rulemaking would also 

eliminate redundant requirements and 

paperwork requirements that are not 

necessary for aviation safety thereby 

reducing burdens for portable oxygen 

concentrator manufacturers, passengers 

who use portable oxygen concentrators 

while traveling, and aircraft operators 

conducting air carrier operations, 

commercial operations or certain 

operations using large aircraft. 

DATES: Send comments on or before 

November 18, 2014. 

ADDRESSES: Send comments identified 

by docket number FAA–2014–0554 

using any of the following methods: 

• Federal eRulemaking Portal: Go to 

http://www.regulations.gov and follow 

the online instructions for sending your 

comments electronically. 

• Mail: Send comments to Docket 

Operations, M–30; U.S. Department of 

Transportation (DOT), 1200 New Jersey 

Avenue SE., Room W12–140, West 

Building Ground Floor, Washington, DC 

20590–0001. 

• Hand Delivery or Courier: Take 

comments to Docket Operations in 

Room W12–140 of the West Building 

Ground Floor at 1200 New Jersey 

Avenue SE., Washington, DC, between 9 

a.m. and 5 p.m., Monday through 

Friday, except Federal holidays. 

• Fax: Fax comments to Docket 

Operations at 202–493–2251. 

Privacy: In accordance with 5 U.S.C. 

553(c), DOT solicits comments from the 

public to better inform its rulemaking 

process. DOT posts these comments, 

without edit, including any personal 

information the commenter provides, to 

http://www.regulations.gov, as 

described in the system of records 

notice (DOT/ALL–14 FDMS), which can 

be reviewed at http://www.dot.gov/

privacy. 

Docket: Background documents or 

comments received may be read at 

http://www.regulations.gov at any time. 

Follow the online instructions for 

accessing the docket or go to the Docket 

Operations in Room W12–140 of the 

West Building Ground Floor at 1200 

New Jersey Avenue SE., Washington, 

DC, between 9 a.m. and 5 p.m., Monday 

through Friday, except Federal holidays. 

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 legal questions concerning this 

action, contact Sara L. Mikolop, Office 

of the Chief Counsel, AGC–220, Federal 

Aviation Administration, 800 

Independence Avenue SW., 

Washington, DC 20591; telephone (202) 

267–3073; email sara.mikolop@faa.gov. 

SUPPLEMENTARY INFORMATION: 

Table of Contents 

I. Authority for this Rulemaking 

II. Overview of the Proposed Rule 

III. Summary of Cost Savings 

IV. Background 

V. Discussion of the Proposed Rule 

A. Definition of Portable Oxygen 

Concentrator 

B. Applicability and Effective Date 

C. Portable Oxygen Concentrator 

Acceptance Criteria 

1. Food and Drug Administration 

Premarket Determination 

2. Electromagnetic Interference Emissions 

Threshold (RTCA DO–160G, Section 21, 

Category M) 

3. Hazardous Materials 

4. Maximum Oxygen Pressure 

D. Manufacturer Certification and Labeling 

E. Prohibition on Smoking or Open Flame 

F. Discussion of Special Federal Aviation 

Regulation No. 106 Requirements 

Excluded From Proposal 

1. Special Federal Aviation Regulation No. 

106 Requirements Addressed in Existing 

Regulations 

a. Stowage of Portable Oxygen 

Concentrators on Board Aircraft 

b. Passenger Movement About the Cabin 

While Using a Portable Oxygen 

Concentrator 

c. Exit Row Seating 

d. Protection of Batteries From Short 

Circuit 

2. Special Federal Aviation Regulation No. 

106 Requirements Excluded in Their 

Entirety 

a. Physician Statement and Pilot in 

Command and Aircraft Operator 

Notification Requirements 

b. Portable Oxygen Concentrator Alarms 

c. Ensuring the Portable Oxygen 

Concentrator is Free of Petroleum 

Products 

d. Use of Salves and Lotions 

e. Carriage of a Sufficient Number of 

Batteries 

G. Miscellaneous 

VI. Advisory Circulars 

VII. 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. Executive Order 13609, Promoting 

International Regulatory Cooperation 


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1Currently, 24 POC models have been approved 

by the FAA and identified in SFAR No. 106 for use 

on board aircraft. 

H. Environmental Analysis 

VIII. Executive Order Determinations 

A. Executive Order 13132, Federalism 

B. Executive Order 13211, Regulations 

That Significantly Affect Energy Supply, 

Distribution, or Use 

IX. Additional Information 

A. Comments Invited 

B. Availability of Rulemaking Documents 

I. Authority for This Rulemaking 

The FAA’s authority to issue rules on 

aviation safety is found in Title 49 of the 

United States Code. 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. 

II. Overview of the Proposed Rule 

This proposed rule would affect the 

use of portable oxygen concentrators 

(POC) on board aircraft in operations 

conducted under 14 CFR parts 121, 125, 

and 135, by replacing the existing FAA 

case-by-case POC approval process in 

Special Federal Aviation Regulation 

(SFAR) No. 106, with FAA acceptance 

criteria. With this NPRM, the agency 

proposes to modify the process by 

which a POC may be deemed acceptable 

for use on board aircraft. Rather than 

amend existing SFAR No. 106 each time 

the FAA accepts a specific model of 

POC for use on board aircraft, this 

proposal identifies acceptance criteria 

for POCs. With the establishment of 

acceptance criteria for POCs the FAA 

would discontinue use of SFAR No. 106 

and remove it from parts 121, 125, and 

135 of title 14 of the Code of Federal 

Regulations (CFR). 

POCs operate by separating oxygen 

from nitrogen and other gases 

comprising ambient air and then 

dispensing the oxygen in concentrated 

form to the user. POCs are the only 

oxygen dispensing devices that a 

passenger requiring oxygen therapy may 

carry for their personal use during 

flight. Although aircraft operators are 

not required to provide medical oxygen, 

the only other options for passengers 

requiring oxygen therapy during flight is 

to procure medical oxygen directly from 

the aircraft operator. Operators typically 

charge for this oxygen service and it can 

be difficult for passengers to coordinate 

service between the carrier and supplier 

of oxygen at the terminal, leaving gaps 

in oxygen service during travel. 

The FAA established standards for the 

use of POCs on board aircraft through 

SFAR No. 106—Rules for use of portable 

oxygen concentrator systems on board 

aircraft. See 70 FR 40156 (July 12, 2005). 

Without SFAR No. 106 an exemption 

from the regulations applicable to 

devices that dispense medical oxygen 

(§ 121.574, § 125.219, or § 135.91) would 

be necessary for passengers to carry on 

and operate their own (not furnished by 

the aircraft operator) POC. See 69 FR 

42324, 42325 (July 14, 2004). The 

agency intended SFAR No. 106 to serve 

as a special, temporary regulation until 

POC performance standards (acceptance 

criteria) could be developed. See 70 FR 

at 40158–40159. 

In 2005, SFAR No. 106 identified the 

first specific POC models approved for 

use on board aircraft. The FAA has 

continued to allow the carriage and use 

of specific POC models only after each 

individual POC manufacturer has 

demonstrated to the FAA that its model 

should be approved for use. Each time 

a new POC is approved by the FAA for 

use on board aircraft, the FAA amends 

SFAR No. 106 by adding the name of 

the POC to the regulation. The FAA has 

amended SFAR No. 106 seven times 

since 2005 to add the names of 

additional POC models as they are 

approved for use in part 121, 125, and 

135 operations—a process as long as up 

to two years.1 The agency proposes to 

replace this cumbersome POC approval 

process with POC acceptance criteria 

and specific labeling requirements to 

identify POCs as satisfying the proposed 

acceptance criteria. 

As with existing requirements 

applicable to POC approval for use on 

aircraft, compliance with the proposed 

acceptance criteria and labeling 

requirement is only necessary for POCs 

used on aircraft. A comparison of the 

proposed acceptance criteria and 

labeling requirement with related SFAR 

No. 106 provisions is provided in Table 

1. 

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

106 REQUIREMENTS

Related SFAR No. 106 requirements Proposed acceptance criteria and labeling requirement 

Food and Drug Administration (FDA) clearance to 

market the device.

The POC must be regulated by the FDA (§ 2(2)) ...........

Note: To satisfy this requirement, manufacturers currently 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 (§ 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 does not contain hazardous materials. 

The POC may not contain any hazardous materials 

subject to the Hazardous Materials Regulations (49 

CFR parts 171–180), except as provided for 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 Hazardous Materials 

Regulations. 


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

106 REQUIREMENTS—Continued 

Related SFAR No. 106 requirements Proposed acceptance criteria and labeling requirement 

Electromagnetic 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 (§ 3(a)(1)).

Note: To satisfy this requirement, it is the current practice of operators to use testing data provided by POC 

manufacturers regarding the electromagnetic emissions of a specific POC model. Manufacturers currently complete testing in accordance with RTCA 

standard 160G, Section 21, Category M. 

Manufacturer must complete testing in accordance with 

RTCA standard 160G, Section 21, Category M. The 

POC electromagnetic emissions must fall below the 

threshold permitted in RTCA standard 160G, Section 

21, Category M. 

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 (§ 2, 

§ 3(a)).

Note: Specific POCs approved for use on board aircraft 

are identified in SFAR No. 106 by manufacturer, 

make, and model. 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. 

POC manufacturers must affix a label for the life of the 

device that certifies compliance with acceptance criteria pertaining to FDA clearance to market the device, hazardous materials, and testing for electromagnetic emissions. 

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. 

In accordance with this proposal, 

manufacturers of POC models not 

identified in SFAR No. 106 would have 

to ensure the POC satisfies the 

acceptance criteria before it may be used 

on board an aircraft. If a manufacturer 

determines that a new POC model meets 

these criteria, the manufacturer would 

not need to seek approval from the FAA 

prior to indicating that a POC is safe for 

air travel. Instead, the manufacturer 

would affix a label to the POC, as 

specified in the proposal, indicating the 

POC meets FAA acceptance criteria. The 

FAA believes this proposed label would 

facilitate passenger and crew 

recognition by identifying the POC as 

safe for use in the cabin during all 

phases of flight. 

The FAA proposes that the 

requirement for labeling apply only to 

POCs not currently listed as approved in 

SFAR No. 106. POC 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. Any 

device that previously demonstrated 

compliance with SFAR No. 106 criteria 

would satisfy the proposed acceptance 

criteria. 

The FAA believes it is not necessary 

or practical to require POC 

manufacturers to retrofit previously 

approved POCs with a label. The FAA 

expects POCs listed in SFAR No. 106 

will decrease over time as they age and 

are replaced with newer models. 

Therefore, the FAA proposes to 

maintain in the proposed regulatory 

text, a list of POCs approved in 

accordance with SFAR No. 106 and 

proposes excepting them from the 

proposed labeling requirement so that 

passengers and crewmembers can 

continue to identify these POCs as 

approved for use on board aircraft. 

In addition, the agency proposes to 

eliminate SFAR No. 106 requirements 

related to POC use on aircraft that are 

addressed elsewhere in title 14 or title 

49 of the Code of Federal Regulations. 

For example, existing regulations 

outside of SFAR No. 106 address 

stowage of carry-on items (§§ 121.285, 

121.589, 125.183, and 135.87) and exit 

row seating (§§ 121.585 and 135.129). 

This proposal would also eliminate 

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 

affected passengers and their physicians 

as well as crewmembers and aircraft 

operators. Table 2 summarizes the 

proposed disposition of all SFAR No. 

106 provisions. 

TABLE 2—SUMMARY OF SFAR NO. 106 PROVISIONS AND PROPOSED DISPOSITION

Summary of SFAR No. 106 provision Description of proposed disposition in NPRM 

• Requirement that the POC is legally marketed in the United States in 

accordance with FDA requirements (§ 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 (§ 3(a)(1)). 

SFAR No. 106 Provisions Reflected in Proposed Acceptance Criteria 

and Labeling Requirement. 

• Prohibition on POCs containing hazardous materials as determined 

by the Pipeline and Hazardous Materials Safety Administration 

(§ 2(1)).

• POC model must be identified in SFAR No. 106 prior to use in part 

121, 125, and 135 operations (§ 2, § 3(a))*.

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

• POC model must be identified in SFAR No. 106 prior to use in part 

121, 125, and 135 operations (§ 2, § 3(a))*. 

SFAR No. 106 Provisions Retained. 


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TABLE 2—SUMMARY OF SFAR NO. 106 PROVISIONS AND PROPOSED DISPOSITION—Continued 

Summary of SFAR No. 106 provision Description of proposed disposition in NPRM 

• 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 (§§ 3.(a)(5) and 3.(b)(3)).

• Requirement for POC user to be capable of responding to alarms or 

to travel with a person who can perform these functions (§ 3.(b)(1)). 

SFAR No. 106 Provisions Eliminated in Their Entirety. 

• Requirement for POC user to ensure that the POC is free of petroleum products or signs of excessive wear or abuse (§ 3.(b)(2)).

• Prohibition on use of salves and lotions unless ‘‘oxygen approved’’ 

(§ 3.(b)(4)).

• Requirement for passenger to carry a sufficient number of batteries 

for duration of flight (§ 3.(b)(5)).

* The list of POCs currently identified in SFAR No. 106 would be maintained in parts 121, 125 and 135. All other POCs would need to satisfy 

the proposed acceptance criteria and bear a label for the life of the device indicating compliance with the acceptance criteria. A detailed discussion regarding the identification of POCs that satisfy the acceptance criteria is provided in the preamble. 

This proposed rule would relieve 

regulatory burdens for POC 

manufacturers as they would no longer 

be required to submit a petition for 

rulemaking to amend SFAR No. 106 for 

each new POC introduced into the 

marketplace and intended for use on 

board aircraft. Similarly, this proposed 

rule would relieve passengers of the 

current paperwork burden of obtaining 

a physician’s statement and notifying 

both the pilot in command and the 

aircraft operator concerning their POC 

usage while on board aircraft. 

III. Summary of Cost Savings 

The FAA estimates that 

manufacturers would save $108,000 

over ten years because they would 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 during flight on board aircraft. 

These cost savings would be reduced 

slightly because manufacturers would 

incur an estimated total one-time cost of 

$22,000 to comply with the proposed 

labeling requirement. The FAA 

estimated additional cost savings 

because of the discontinuation of certain 

requirements from SFAR No. 106. Total 

estimated cost savings are presented in 

the table below. 

IV. Background 

On July 12, 2005 (70 FR 40156), the 

FAA published a final rule adding 

SFAR No. 106. This final rule permitted 

the use of POCs on board aircraft to 

address the needs of passengers 

requiring oxygen therapy while 

traveling. 

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. At the time the agency 

published SFAR No. 106, the FAA did 

not require aircraft operators to provide 

medical oxygen and many regional air 

carriers and some larger air carriers did 

not provide this service. Those carriers 

that did allow passengers to use the 

medical oxygen provided the 

compressed oxygen themselves and 

typically charged a fee for this service. 

(The agency notes that today, virtually 

no certificate holders conducting part 

121 operations provide in-flight 

supplemental oxygen for passengers.) 

Further, passengers requiring oxygen 

therapy during travel faced difficulty 

coordinating service between the carrier 

and the supplier of medical oxygen to 

ensure coverage at the terminal, gate to 

gate, and on board the aircraft. 

Sometimes, passengers would spend at 

least part of the time travelling without 

medical oxygen due to service problems 

with the oxygen provider. See 70 FR 

40156, 40156 (July 12, 2005). 

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%. 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 (not furnished by the aircraft 

operator). 

In 2004, rather than wait for petitions 

for exemption from the existing 

regulations, the FAA published an 

NPRM proposing SFAR No. 106. See 69 

FR 42324 (July 14, 2004). In the NPRM, 


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2 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). 

3AC 120–95 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 . . .’’ 

4Portable oxygen concentrators are a subset of 

portable oxygen generators defined by the FDA in 

21 CFR 868.5440. 

the agency proposed to permit 

passengers to carry on and operate their 

own POC on board an aircraft as long as 

certain conditions were met. 

The SFAR No. 106 final rule, 

published July 12, 2005, established 

criteria for FAA approval of POCs for 

use on board aircraft. This final rule 

prohibited passengers from using POCs 

on board aircraft under part 121, 125, 

and 135 operations, unless those POCs 

satisfied the approval criteria and were 

identified by manufacturer and model 

name in SFAR No. 106. This final rule 

also established POC operating rules for 

aircraft operators, crewmembers and 

passengers. 

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 made conforming 

amendments to 14 CFR parts 125 and 

135 to apply the requirements of SFAR 

No. 106 to part 119 certificate holders 

conducting operations under parts 125 

and 135. 

Since the FAA originally published 

SFAR No. 106, it has been amended 

seven times to list additional POCs and 

currently identifies 24 POCs that may be 

used on board aircraft.2 This process is 

time-consuming for POC manufacturers 

and the FAA. POC manufacturers who 

want the FAA to approve a POC for use 

in part 121, 125, and 135 operations 

must petition the FAA for rulemaking to 

amend SFAR No. 106, by adding their 

POC model to the list and provide the 

FAA with Food and Drug 

Administration (FDA) and Pipeline and 

Hazardous Materials Safety 

Administration (PHMSA) 

documentation required for the FAA to 

make a determination whether the POC 

may be safely used on board aircraft. 

This process is also time-consuming for 

the FAA because rulemaking must be 

accomplished each time a new POC 

model is added to SFAR No. 106. As a 

result of the rulemaking required to add 

a POC model to the list of POCs in 

SFAR No. 106, passengers may not use 

a POC on board an aircraft in part 121, 

125, or 135 operations until the FAA 

identifies the device they wish to use in 

SFAR No. 106. 

V. Discussion of the Proposed Rule 

When SFAR No. 106 was originally 

published, the FAA committed to 

establishing a single standard for all 

POC devices. Whenever possible, the 

FAA tries to regulate by creating 

performance-based standards rather 

than approving specific devices on a 

case-by-case basis. However, the FAA 

determined that the quickest way to 

serve both the passenger and the aircraft 

operator and to avoid creating 

circumstances that would stifle new 

technology, was to allow the use of 

specific POCs approved by the FAA for 

use on aircraft and identified in SFAR 

No. 106, a special, temporary regulation. 

See 70 FR at 40157–40159. 

After evaluating the provisions 

contained in SFAR No. 106, the relevant 

provisions of existing Hazardous 

Materials Regulations (HMR) (49 CFR 

parts 171–180), and a decade of 

accumulated knowledge and experience 

the FAA has gained with POCs, the FAA 

proposes to replace the POC case-bycase approval process with 

performance-based standards 

(acceptance criteria) as envisioned by 

the FAA at the time SFAR No. 106 was 

developed. The proposed rule would 

specify POC acceptance criteria for POC 

use in part 121, 125, and 135 operations. 

A manufacturer would then certify the 

device meets the FAA acceptance 

criteria by affixing a label for the life of 

the device that certifies the POC 

conforms to FAA acceptance criteria. 

Additionally, this proposed rule would 

prescribe limited operational 

requirements governing the use of POCs 

on board aircraft. The proposed 

requirements are discussed below. 

A. Definition of Portable Oxygen 

Concentrator 

Currently, SFAR No. 106 explains 

POCs perform by separating oxygen 

from nitrogen, and other gasses 

contained in ambient air, and 

dispensing the oxygen in a concentrated 

form to the user. 

The FAA proposes to define a POC 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 

explanation used in existing SFAR No. 

106 and Advisory Circular 120–95, 

Portable Oxygen Concentrators 3 as well 

as the device description used by POC 

manufacturers and the FDA,4 the federal 

agency with primary regulatory 

authority over POCs for medical use. 

By including this definition in 14 CFR 

1.1, the FAA intends to distinguish 

POCs from portable oxygen generators 

and other medical devices that use 

compressed or liquid oxygen for 

medical oxygen therapy, because 

devices that use compressed or liquid 

oxygen must satisfy separate and more 

rigorous requirements to mitigate the 

risks they present. 

B. Applicability and Effective Date 

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. Further, 

SFAR No. 106 does not require aircraft 

operators to allow passengers to operate 

POCs on board aircraft. Rather, it 

authorizes the use of specific POCs on 

board aircraft in operations conducted 

under parts 121, 125, or 135 if the 

conditions in SFAR No. 106 are 

satisfied. 

With this NPRM, the agency proposes 

to modify the process by which a POC 

may be deemed acceptable for use on 

board aircraft. Rather than amend 

existing SFAR No. 106 each time the 

FAA accepts a specific model of POC for 

use on board aircraft, this proposal 

identifies acceptance criteria for POCs. 

With the establishment of acceptance 

criteria for POCs the FAA would 

discontinue use of SFAR No. 106 and 

remove it from parts 121, 125, and 135 

of title 14 of the CFR. 

Consistent with SFAR No. 106, this 

proposal applies only to those POC 

models intended for use on board 

aircraft in part 121, 125, and 135 

operations and does not create a 

requirement for operators to allow POC 

use. Requirements for air carriers to 

allow the use of a POC on an aircraft 

continue to be found in 14 CFR part 

382, Nondiscrimination on the Basis of 

Disability in Air Travel. 

The agency seeks to make this 

proposal effective as soon as practicable. 

The agency recognizes, however, that 

part 119 certificate holders may need to 

revise operating manuals and training 

programs. The agency expects these 

revisions to occur within the normal 

course of business and is therefore 

considering an effective date of 90 days 

after the publication of the final rule in 

the Federal Register. 

C. Portable Oxygen Concentrator 

Acceptance Criteria 

The agency proposes to require POCs 

used on board aircraft to satisfy specific 

acceptance criteria. The acceptance 

criteria are discussed in more detail in 

this section of the preamble and are 

summarized as follows: 


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5A 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. 

6All InFOs can be found at http://www.faa.gov/ 

other_visit/aviation_industry/airline_operators/

airline_safety/info/all_infos/. 

7RTCA and components of RTCA function as 

advisory committees in accordance with the 

provisions of the Federal Advisory Committee Act 

(FACA), as amended, Public Law 92–463, 5 U.S.C. 

App. 2. RTCA membership is drawn from across the 

aviation industry. RTCA employs the expertise of 

the aviation community to generate 

recommendations in response to requests from the 

FAA to address a wide range of technical aviation 

issues or questions. RTCA generally provides 

recommendations (1) broad-gauged policy and 

investment priority recommendations used by FAA 

when considering policy and program decisions; 

and (2) minimum performance standards, reports, 

and guidance documents used by FAA in regulatory 

decisions and rulemaking. See FAA Order 

1110.77U, Charter for RTCA, Inc., April 1, 2013. 

http://www.faa.gov/documentlibrary/media/order/ 

1110.77u.pdf. 

• The POC manufacturer complies 

with all FDA requirements to legally 

market the device in the United States. 

• The POC may not contain any 

hazardous materials subject to the 

Hazardous Materials Regulations (49 

CFR parts 171 through 180) except as 

provided for 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 per the HMR. 

• The POC electromagnetic emissions 

must fall below the threshold permitted 

in RTCA standard 160G, Section 21, 

Category M. 

The agency further proposes that any 

POC (except those previously approved 

for use on aircraft under SFAR No. 106) 

carried or used by a passenger on an 

aircraft in part 121, 125, or 135 

operations must bear a manufacturer’s 

label using a means to ensure it will 

remain affixed for the life of the device 

indicating compliance with these FAA 

acceptance criteria. 

1. Food and Drug Administration 

Premarket Determination 

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 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). 

Currently, SFAR No. 106 requires all 

POCs used on board aircraft in 

operations conducted under 14 CFR 

parts 121, 125, and 135 must be legally 

marketed 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 portable oxygen 

concentrator (POC). To demonstrate 

compliance with this requirement, POC 

manufacturers must submit evidence 

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.5

The FAA proposes to maintain the 

requirement that any POC used on 

board an aircraft must be cleared or 

approved by the FDA for marketing in 

the United States. However, 

manufacturers would no longer submit 

evidence of this clearance or approval to 

the FAA. Rather, POC manufacturers 

would certify that the FDA has 

approved the device for marketing in 

the United States by affixing a label to 

the POC, in which the manufacturer 

confirms compliance with all FAA 

requirements for the use of the POC on 

board aircraft. The proposed labeling 

requirement is discussed in more detail 

later in this preamble. 

As an alternative to identifying the 

requirement for FDA approval to legally 

market the device as one of the POC 

acceptance criteria, the agency is 

considering incorporating this one 

acceptance criterion into the POC 

definition because this criterion already 

applies to all POCs marketed in the 

United States per FDA requirements and 

not just those POCs intended for use on 

aircraft. The agency seeks comment on 

this alternative. 

2. Electromagnetic Interference 

Emissions Threshold (RTCA DO–160G, 

Section 21, Category M) 

The agency recognizes POCs as a type 

of portable electronic device (PED) and 

permits the use of PEDs during flight, 

only if the aircraft operator has 

determined the device does not cause 

interference with the navigation or 

communication system of the aircraft in 

which the device will be used. Further, 

in accordance with §§ 121.306, 125.204, 

and 135.144, the aircraft operator is 

responsible for determining which PEDs 

may be safely used on its aircraft. 

Each operator may establish a method 

to make a determination regarding the 

effects of PEDs on its aircraft’s avionics. 

Historically, a common method for 

making this determination has been to 

complete evaluations of electromagnetic 

interference (EMI) on a device-by-device 

basis which involves comparing the 

device’s emissions against the current 

RTCA DO–160 standards for airborne 

equipment. 

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., meet the requirements of 

RTCA DO–307 or another PED tolerance 

demonstration). See InFO 13010 and 

InFO 13010SUP.6 The agency does not, 

however, require aircraft assessment of 

PED tolerance in accordance with InFO 

13010 and InFO 13010SUP. These PED 

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 if it wants to 

expand the use of passenger supplied 

and operated PEDs via a determination 

of PED tolerance for certain aircraft 

types. Some aircraft operators may 

choose to continue to rely on the 

individual PED evaluations that occur 

today. 

SFAR No. 106, section 3(a)(1) 

contains a requirement pertaining to 

POC interference with aircraft 

equipment that has the same effect as 

the requirements in §§ 121.306, 125.204, 

and 135.144 pertaining to all PEDs. 

SFAR No. 106 permits operators 

engaged in part 121, 125, and 135 

operations to allow passengers the use 

of specific POC models that have been 

tested to ensure that they will not 

interfere with the aircraft electrical, 

navigation or communication 

equipment. 

For POC EMI evaluation, the FAA 

currently accepts as proof of noninterference, emissions test results 

provided by manufacturers showing a 

specific POC does not exceed certain 

maximum emissions thresholds 

established by RTCA in DO–160, 

Environmental Conditions and Test 

Procedures for Airborne Equipment.7

The agency has determined that Section 

21 Category M of RTCA DO–160 

establishes safe and conservative 


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8The 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. 

9See Advisory Circular 120–95, Portable Oxygen 

Concentrators, Advisory Circular 91–21.B, Use of 

Portable Electronic Devices Aboard Aircraft. 

10The FAA intends to incorporate RTCA DO– 

160G, Section 21, Category M by reference in 

§§ 121.574, 125.219 and 135.91. 

11On July 29, 2014, PHMSA issued a final rule, 

‘‘Hazardous Materials: Transportation of Lithium 

Batteries’’ (RIN 2137–AE44). See 79 FR 46012 

(August 6, 2014). Compliance with this final rule 

is required six months after the date of publication 

in the Federal Register, February 6, 2015. For 

purposes of this NPRM, the relevant changes that 

will be put in place by the PHMSA final rule are 

those that (1) remove Special Provision 188 and 

relocate it, in part, to a revised 49 CFR 173.185; (2) 

replace equivalent lithium content with Watt-hours 

for lithium ion cells and batteries; and (3) revise the 

HMR exceptions for hazardous materials carried by 

aircraft passengers and crewmembers. The revisions 

to the HMR exceptions for hazardous materials 

carried by aircraft passengers and crewmembers 

will take a more conservative approach than 

existing regulations (i.e., requiring approval by the 

air operator for the carriage of spare lithium ion 

batteries larger than 8 grams (approximately 100 

Wh) and reducing the maximum Watt-hours for 

spare lithium ion batteries from 300 Wh to 160 

Wh)). However, given that compliance with the 

PHMSA final rule will not be required until after 

the close of the comment period for this NPRM, for 

purposes of the passenger and crewmember 

emissions limits for electronic devices 

on board aircraft.8

The agency allows aircraft operators 

to use emissions test results provided by 

POC manufacturers to demonstrate 

compliance with section 3(a)(1) of SFAR 

No. 106.9 It is current practice for 

manufacturers to provide the RTCA test 

compliance statements to the FAA; the 

FAA then makes the RTCA test 

compliance statements available on its 

Web site for aircraft operator reference. 

The RTCA compliance statements may 

be viewed at http://www.faa.gov/about/ 

initiatives/cabin_safety/ 

portable_oxygen/. 

The agency recognizes the current 

SFAR No. 106 requirement for an 

operator to evaluate POC interference 

with aircraft equipment is redundant 

with the requirements in §§ 121.306, 

125.204, and 135.144. Further, many 

part 121 operators have already 

conducted aircraft assessment of PED 

tolerance in accordance with InFO 

13010 and InFO 13010SUP, which 

would make an independent assessment 

of POC electromagnetic emissions 

unnecessary. 

Nevertheless, because of the need to 

ensure service for passengers who 

require oxygen during air travel, the 

FAA believes it is necessary to create a 

regulatory structure to ensure that 

passengers may continue to use POCs 

on board aircraft even when an operator 

does not choose to assess a POCs 

electromagnetic emissions, or assess the 

aircraft they operate for PED tolerance. 

Although aircraft operators conducting 

part 121, 125, and 135 operations are 

the only entities authorized to provide 

medical oxygen for use on their aircraft 

during these operations, they are not 

required to do so. Those carriers that do 

provide medical oxygen typically charge 

for the service although many carriers 

simply do not offer medical oxygen at 

all; and, it can be difficult for the 

passenger to coordinate oxygen service 

between the carrier and a supplier of 

medical oxygen at the terminal, leaving 

gaps in oxygen service during travel. 

POCs, however, provide an effective 

alternative for passengers requiring 

uninterrupted oxygen therapy during 

travel. The current practice used by POC 

manufacturers to demonstrate that POC 

electromagnetic emissions do not cause 

interference with aircraft equipment is 

an effective way to ensure that POCs 

will be available for continuous use for 

the duration of a passenger’s travel, 

including all phases of flight and 

movement on the surface. 

Thus, consistent with the current 

practice, the agency proposes to require 

POC manufacturers to conduct a POC 

EMI assessment in accordance with 

RTCA DO–160G, Section 21, Category 

M 10 for each POC the manufacturer 

intends to market for use on aircraft and 

label as compliant with FAA POC 

acceptance criteria. As currently 

permitted, a POC that tests below the 

maximum emission threshold contained 

in RTCA DO–160G, Section 21, Category 

M, in all modes of operation, may be 

used on board the aircraft during all 

phases of flight without any additional 

testing by the aircraft operator. In 

addition, POCs currently approved by 

the FAA that have demonstrated 

emissions below the maximum 

emissions threshold in DO–160G, 

Section 21, Category M will not need to 

be retested prior to use on board aircraft. 

The agency also proposes to add POCs 

to the list of devices excepted from the 

general PED testing requirements in 

§§ 121.306, 125.204, and 135.144 

because the testing requirements in 

§§ 121.306, 125.204, and 135.144 are 

redundant and unnecessary for POCs 

that have completed POC EMI 

assessments in accordance with RTCA 

DO–160, Section 21, Category M. 

The agency seeks comment on an 

alternate approach to the acceptance 

criterion pertaining to POC-specific EMI 

assessments that would eliminate 

redundancy in those instances when 

operators test aircraft for PED tolerance 

without affecting the opportunity for 

POC use on aircraft. Specifically, the 

agency seeks comment on an alternative 

to the proposed acceptance criterion 

pertaining to POC-specific EMI 

assessments that would allow POC 

electromagnetic emissions to be 

assessed under the general PED 

regulatory structure in existing 

§§ 121.306, 125.204, and 135.144. Under 

this alternate approach, the agency 

assumes that manufacturers would 

continue to voluntarily complete the 

RTCA testing they complete today if 

they want a POC to be available for use 

on aircraft because not all operators 

have conducted aircraft assessments of 

PED tolerance. The agency seeks 

comment on how this alternative 

approach to POC EMI assessments 

would affect passenger use of POCs on 

aircraft and whether this alternative 

would result in possible burdens on 

passengers and aircraft operators. 

Further, the agency recognizes that 

other Federal agencies may require 

electromagnetic compatibility 

assessments that may test to standards 

that could be used to demonstrate 

compliance with the generally 

applicable PED requirements. 

Accordingly, the agency seeks comment 

on (1) whether there are other 

electromagnetic compatibility 

assessments that POC manufacturers 

complete, that test to a standard that is 

technically equivalent to the standard in 

RTCA DO–160G, Section 21, Category 

M, and (2) whether there are any 

differences in the standards of any 

alternate emissions assessments. 

3. Hazardous Materials 

PHMSA 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 regulations (the 

Hazardous Materials Regulations (HMR) 

(49 CFR parts 171 through 180)) and 

standards for classifying, handling and 

packaging shipments of hazardous 

materials within the United States. 

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 or 

lithium ion batteries often used to 

power these units are hazardous 

materials subject to PHMSA regulations 

for the transportation of batteries and 

the carriage of batteries by aircraft 

passengers.11


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exceptions, the FAA continues to refer to the 

lithium ion battery requirements that will remain in 

effect until compliance with the new regulations 

pertaining to these exceptions is required. In light 

of this circumstance, the FAA requests that any 

comments pertaining to lithium ion batteries used 

in POCs or carried as spares for POCs, consider the 

impact of the PHMSA final rule. 

12The lithium ion battery exception was drafted 

to be consistent with the International Civil 

Aviation Organization Technical Instructions for 

the Safe Transport of Dangerous Goods by Air 

(ICAO Technical Instructions) at the time of the 

rulemaking. See 72 FR 44930, 44937 (August 9, 

2007). The ICAO Technical Instructions have since 

been updated. PHMSA evaluated the updated ICAO 

Technical Instructions in a separate rulemaking 

initiative that has recently resulted in a final rule 

amending the lithium ion battery exception. See 79 

FR 46012 (August 6, 2014). 

13As previously noted, beginning on February 6, 

2015, the upper limit for the maximum Watt-hours 

will be reduced from 300 Wh to 160 Wh and 

approval of the air operator will be required to carry 

these larger batteries. See 79 FR 46012 (August 6, 

2014). 

In general, a lithium ion battery that 

is more than 8 grams aggregate lithium 

content (approximately 100 Wh) must 

satisfy the shipping and packaging 

requirements of the HMR. See 49 CFR 

173.185. Lithium ion batteries of 8 

grams or less aggregate lithium content 

(approximately 100 Wh) are exempt 

from most requirements of the HMR. 

See 49 CFR 173.185. 

The agency notes however, that 

PHMSA allows exceptions for the 

carriage of specified hazardous 

materials on board aircraft when carried 

by aircraft passengers or crewmembers, 

provided certain requirements are met. 

For example, aircraft passengers may 

carry an unlimited number of lithium 

ion batteries of 8 grams (100 Wh) or less 

and up to two lithium ion batteries of 

8 grams up to 25 grams (100–300 Wh) 

if each spare battery is protected to 

prevent short circuits. Beginning on 

February 6, 2015, compliance with a 

more conservative upper limit of 160 

Wh will be required. See 79 FR 46012 

(August 6, 2014); 49 CFR 

175.10(a)(18).12

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 the PHMSA 

Administrator. See SFAR No. 106, 

section 2(1). Under the authority of 

SFAR No. 106, the agency requires POC 

manufacturers to obtain a determination 

letter from PHMSA stating the POC does 

not contain hazardous materials as one 

of the prerequisites for the FAA to 

identify the POC in the SFAR. (PHMSA 

reviews information provided by the 

POC manufacturer for each POC model 

as the basis for this determination 

letter.) Although the agency proposes to 

maintain the broad prohibition on 

hazardous materials in POCs used by 

passengers on board aircraft, the agency 

proposes to remove the current 

requirement for a PHMSA 

determination letter confirming the POC 

does not contain hazardous materials. 

The PHMSA determination letter is 

unnecessary given the prohibition on 

hazardous materials in POCs. 

Further, this proposal provides direct 

references to PHMSA regulations (the 

HMR) including the exceptions for 

passengers identified in 49 CFR 175.10. 

As a result, up to two batteries larger 

than those currently permitted by SFAR 

No. 106 may be carried to power POCs 

that are used on board aircraft. SFAR 

No. 106 does not contain any specific 

language regarding the aggregate lithium 

content of any battery used to power a 

POC (installed or spare). However, given 

the SFAR No. 106 prohibition of 

hazardous materials in a POC, SFAR No. 

106 does effectively limit lithium ion 

batteries to 8 grams or less aggregate 

lithium content. A lithium ion battery 

with more than 8 grams aggregate 

lithium content is subject to the 

requirements of the HMR. See 49 CFR 

173.185. Consequently, in accordance 

with the limits of SFAR No. 106, aircraft 

passengers are not permitted to use or 

carry a POC with a lithium battery or a 

spare lithium battery that is larger than 

8 grams. However, the FAA notes this 

battery limitation does not apply to 

other portable electronic devices 

powered by lithium ion batteries being 

used or carried in accordance with 

aircraft passenger and crew exceptions 

in 49 CFR 175.10(a)(18). 

Currently, neither the HMR nor SFAR 

No. 106 limits the number of lithium 

ion batteries that passengers may carry. 

Passengers using or carrying POCs on 

board aircraft may carry as many 

lithium ion batteries as they wish as 

long as each battery has an aggregate 

lithium content of 8 grams or less and 

the batteries are carried in carry-on 

baggage only. By allowing the 

exceptions in 49 CFR 175.10 to apply to 

POCs, passengers would also be able to 

carry and use up to two batteries larger 

than 8 grams, but not more than 25 

grams aggregate lithium content 

(approximately 300 Wh) to power their 

POCs subject to the limitations of 49 

CFR 175.10(a)(18).13 See 79 FR 46012 

(August 6, 2014). 

While this proposed rule would 

expand battery options for passengers 

who use POCs, it would remain 

consistent with the level of lithium ion 

battery safety established by PHMSA. In 

2007, after an evaluation of the 

transportation mode, battery size, 

quantity of batteries, product design, 

and emergency response, PHMSA (in 

consultation with the FAA), issued a 

final rule on the transportation of 

lithium batteries. In this 2007 final rule, 

PHMSA imposed stricter and more 

effective safeguards for the 

transportation of certain types and sizes 

of lithium batteries in certain 

transportation contexts, while at the 

same time providing an exception from 

these requirements for the carriage of 

lithium ion batteries by passengers in 

passenger carrying aircraft operations. 

While PHMSA acknowledged that 

lithium batteries are considered a 

hazardous material for purposes of 

transportation regulation because they 

can overheat and ignite in certain 

conditions, like certain other products 

that contain hazardous materials 

PHMSA determined that lithium 

batteries can be safely transported 

provided appropriate precautions are 

taken in design, packaging, handling, 

and emergency response as prescribed 

by the HMR. See 72 FR 44930, 44930 

(August 9, 2007). 

After consideration of the current 

PHMSA requirements applicable to 

lithium batteries carried in accordance 

with § 175.10(a)(18) and the pending 

PHMSA amendments pertaining to the 

carriage of lithium ion batteries on 

aircraft, the FAA has determined that 

SFAR No. 106 is unnecessarily 

restrictive with regard to battery size. 

Accordingly, this proposal allows 

batteries of expanded size to be installed 

in POCs or carried as spares to be used 

with POCs. 

4. Maximum Oxygen Pressure 

As previously discussed, the SFAR 

No. 106 acceptance 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. 

The FAA believes this operating 

pressure restriction should continue to 

be applied so as to ensure that POCs 

used on board aircraft will not present 

the hazards associated with compressed 

oxygen. Accordingly, the agency 


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proposes to include a design standard 

establishing a maximum oxygen 

pressure allowed for POCs intended for 

use on board aircraft of less than 200 

kPa gauge (29.0 psig/43.8 psia) at 20 °C 

(68 °F). Under the proposed rule, a POC 

that exceeds this threshold could not be 

labeled as meeting the standards for use 

on board aircraft. 

The agency believes that inclusion of 

the requirement regarding oxygen 

pressurization does not overlap with 49 

CFR 173.115, 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 Certification and 

Labeling 

Currently, the agency does not require 

manufacturers to label a POC approved 

for use in accordance with SFAR No. 

106 to certify or indicate compliance 

with the standards in SFAR No. 106. 

Instead, the agency conducts a review of 

each individual POC when a 

manufacturer seeks to market its POC 

for use on board aircraft. If the agency 

determines the POC meets the criteria 

for FAA approval for use on board 

aircraft, it amends SFAR No. 106 to add 

the specific POC model. 

As previously discussed, the FAA 

proposes to replace its current case-bycase POC approval process with 

acceptance criteria. To certify POC 

compliance with the acceptance criteria, 

the FAA proposes to require 

manufacturers to affix a label to the POC 

certifying it meets the FAA acceptance 

criteria. The FAA’s proposed labeling 

requirement is the only element of the 

proposal that is not based on SFAR No. 

106. 

The FAA proposes to require the label 

to contain the following statement: ‘‘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.’’ The agency proposes to 

require manufacturers to use red 

lettering for this statement to facilitate 

recognition of the POC by passengers 

and crewmembers. The label would also 

serve to inform the user that the POC is 

safe for use in the cabin during all 

phases of flight because one of the 

proposed acceptance criteria is the 

completion of EMI testing in accordance 

with RTCA DO–160G, Environmental 

Conditions and Test Procedures for 

Airborne Equipment, Section 21, 

Category M. 

The agency also proposes to require 

POC manufacturers to use a labeling 

method that would ensure that the label 

remains affixed for the life of the device. 

The purpose of this requirement is to 

ensure the label cannot be transferred to 

another type of oxygen dispensing 

device presenting a higher safety risk 

without corresponding mitigation 

measures (e.g. a device that uses 

compressed oxygen). 

Further the proposed labeling 

requirement is consistent with 

recommended labeling practices 

described in InFO 09006, Department of 

Transportation (DOT) Final Rule, 

‘‘Nondiscrimination on the basis of 

Disability in Air Travel’’ and the Use of 

Respiratory Assistive Devices on 

Aircraft, and anticipated in the DOT 

final rule ‘‘Nondiscrimination on the 

basis of Disability in Air Travel.’’ See 73 

FR 27614, 27630 (May 13, 2008). The 

agency reiterates only those 

manufacturers intending to market their 

devices for use on board aircraft must 

comply with the acceptance criteria in 

this proposal. This proposal does not 

affect other Federal agencies’ regulatory 

requirements applicable to POCs. 

Accordingly, POC manufacturers that 

choose not to comply with the 

acceptance criteria required for POC use 

on board aircraft would not be subject 

to the FAA’s proposed POC labeling 

requirement, and in that case, a 

passenger would not be permitted to use 

the non-labeled POC on board an 

aircraft in part 121, 125, or 135 

operations. 

The FAA believes POC manufacturers 

wishing to market their POCs for use on 

board aircraft will be able to readily 

comply with this proposed labeling 

requirement. As discussed in the 

Regulatory Notices and Analysis section 

of this preamble, the FAA assumes most 

POC manufacturers currently affix 

labels to POCs and thus this proposed 

labeling requirement should result in 

minimal costs. 

This proposed labeling requirement 

would not apply to POCs currently 

approved under SFAR No. 106, as the 

FAA believes it is not necessary or 

practical to require POC manufacturers 

to label POCs identified in SFAR No. 

106 as approved for use on board 

aircraft. POC models previously listed 

in SFAR No. 106 as approved for use on 

board aircraft have satisfied SFAR No. 

106 criteria and would also satisfy the 

proposed acceptance criteria. In 

addition, the FAA expects use of POCs 

already listed in SFAR No. 106 will 

lessen over time as the POCs age and 

their users replace older models with 

newer ones obviating the need to retrofit 

existing POC models with a label. 

Thus, the FAA proposes including in 

the regulatory text of §§ 121.574, 

125.219, and 135.91, the list of POC 

models currently identified in SFAR No. 

106 to assist with their identification by 

crewmembers. The FAA notes that a 

POC manufacturer could elect to place 

a label on a POC previously approved 

under SFAR No. 106 indicating the POC 

complies with the FAA’s requirements 

for POCs used on board aircraft. 

Although, the agency is not proposing to 

require a label for POCs identified in 

SFAR No. 106, the FAA seeks 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. 

Finally, the agency is aware that some 

manufacturers of POCs identified in 

SFAR No. 106 currently apply a label to 

those POCs indicating FAA approval for 

use on board aircraft. The agency 

clarifies however, this label does not 

provide a means by which a certificate 

holder, crewmember or passenger may 

determine compliance with SFAR No. 

106 or with this proposal. The only 

label that may be used to determine 

compliance with this proposal 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 the proposal. 

To mitigate any potential confusion 

that may arise from a POC label 

indicating FAA approval that pre-dates 

the labeling proposal in this NPRM, 

certificate holders, crewmembers and 

passengers must determine whether a 

particular POC may be used on a part 

121, 125, or 135 operation by either (1) 

identifying the specific POC on the list 

of POC models approved for use on 

board aircraft under SFAR No. 106 and 

incorporated into the proposed 

regulatory text; or (2) by reviewing the 

manufacturer’s certification statement 

on the label prescribed by this proposal. 

E. Prohibition on Smoking or Open 

Flame 

Consistent with SFAR No. 106, the 

FAA proposes to retain the existing 

prohibition on smoking or open flame 

within 10 feet of any person using a 

POC. 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. 


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Accordingly, the agency proposes to 

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 specifically 

prohibiting an open flame. 

The prohibition on smoking 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, the agency proposes to 

explicitly prohibit an open flame in 

addition to smoking as in SFAR No. 

106. The agency also proposes to amend 

the regulatory text in § 125.219(b) to 

clarify that smoking is not only 

prohibited within 10 feet of where 

medical oxygen is being used but that it 

is also prohibited within 10 feet of 

where it is stored. This clarification 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). 

F. Discussion of Special Federal 

Aviation Regulation No. 106 

Requirements Excluded From Proposal 

As previously noted, this rule 

proposes that several requirements 

currently contained in SFAR No. 106 be 

included in the new regulations 

establishing acceptance criteria for 

POCs. The FAA has determined, 

however, that many of the requirements 

currently included in SFAR No. 106 are 

overly prescriptive or redundant with 

existing rules and are therefore not 

necessary. Accordingly, the FAA is not 

proposing to include them in this rule. 

A discussion of the SFAR No. 106 

requirements excluded from this 

proposal and the rationale therefore 

follows. 

1. Special Federal Aviation Regulation 

No. 106 Requirements Addressed in 

Existing Regulations 

a. Stowage of Portable Oxygen 

Concentrators on Board Aircraft 

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

that during movement on the surface, 

takeoff, and landing, the POC must (1) 

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; or (2) 

if it is to be operated by the user, be 

used 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. 

Existing FAA regulations in parts 121, 

125, and 135, address the stowage of 

carry-on items and carriage of cargo in 

the passenger cabin to ensure an 

appropriate stowage location and 

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 stowage requirement 

in SFAR No. 106 is unnecessary and the 

FAA is proposing to eliminate it. 

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 continue to use the unit 

while stowed under a seat. 

b. Passenger Movement About the Cabin 

While Using a Portable Oxygen 

Concentrator 

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

‘‘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.’’ 

The agency included this provision in 

SFAR No. 106 in response to 

commenters’ concerns that limitations 

on the ability of medical oxygen users 

to move around the cabin during flight, 

would apply to POC users. In the final 

rule implementing SFAR No. 106, the 

agency specifically 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. 

The proposed revisions to §§ 121.574, 

125.219, and 135.9, distinguish 

requirements applicable to passengers 

carrying and using POCs from 

requirements applicable to passenger 

use of other equipment for the storage, 

generation or dispensing of oxygen. 

Therefore, if this proposed rule is 

finalized, a provision similar to section 

3(a)(6) of the SFAR would be 

unnecessary. 

c. Exit Row Seating 

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

that no person using a POC is permitted 

to sit in an exit row. The FAA believes 

this requirement is unnecessary because 

current regulations in parts 121 and 135 

require the certificate holder to 

determine the suitability of passengers it 

permits to occupy exit row seats. See 14 

CFR 121.585 and 135.129. For example, 

a person using a POC may not be 

qualified to sit in an exit row if the POC 

would inhibit the passenger’s ability to 

handle the emergency exit and assist 

other passengers exiting the aircraft. 

Therefore, the FAA proposes to 

eliminate this SFAR No. 106 

requirement. 

The FAA notes that part 125 does not 

specifically address the suitability of 

passengers for exit row seating. 

However, this proposed rule does not 

affect the ability of part 125 operators to 

apply their current seating policies. 

d. 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 are 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). 

When a battery-powered POC is carried 

on board aircraft as carry-on baggage, 

and is not intended to be used during 

the flight, the battery must be removed 

and packaged 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 portion of SFAR No. 106, section 

3(b)(6) addressing spare batteries is 

redundant with PHMSA regulations 

applicable to spare batteries carried by 

passengers on board aircraft. PHMSA 

regulations require spare batteries 

carried on board aircraft to be 

individually protected from short circuit 

to mitigate the risk of a fire during 

flight. See 49 CFR 175.10(a)(18). Thus, 

SFAR No. 106 provisions applicable to 

spare batteries carried by passengers on 

board aircraft for use in POCs are 

unnecessary and excluded from this 

proposal. 

However, 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. Existing PHMSA regulations 

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). 


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14Pursuant to Department of Transportation 

regulations, U.S. and foreign air carriers may 

require passengers who expect to use a POC during 

flight to obtain a physician’s statement (i.e., medical 

certificate) as a condition of transportation. See 14 

CFR 382.23(b)(1)(ii). 

15The agency reviewed data from the following 

accident, incident and voluntary reporting 

databases: 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). 

Based on the agency’s review of the 

24 POC models currently accepted for 

use on board aircraft, the FAA has 

determined those POCs all have at least 

two design features preventing 

inadvertent or accidental operation. 

Thus, for those POCs that are currently 

accepted for use on board aircraft, 

batteries may remain in the devices 

while 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. Specifically, PHMSA requires 

all lithium ion batteries to include 

overcharge protection and testing that 

prevents a battery from overheating and 

preventing a fire. 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 current 

approved POCs and 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 batteries 

available for new devices must be 

equipped with overcharge protection, 

therefore, the risk of a fire originating 

from the battery is minimal. 

Accordingly, the FAA did not propose 

to retain this provision in the NPRM. 

2. Special Federal Aviation Regulation 

No. 106 Requirements Excluded in 

Their Entirety 

a. Physician Statement and Pilot in 

Command and Aircraft Operator 

Notification Requirements 

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

passengers intending to use a POC to 

have a written statement, to be kept in 

that person’s possession, signed by a 

licensed physician 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 must allow the crew of the 

aircraft to review the contents of the 

physician’s statement. Similarly, SFAR 

No. 106, section 3(a)(5) requires pilot in 

command notification whenever a 

passenger brings and intends to use a 

POC on board the aircraft. The pilot in 

command must also be informed about 

the contents of the physician’s written 

statement including the nature of the 

passenger’s oxygen needs and the 

passenger’s ability to understand 

operational and warning information 

presented by the POC. 

The FAA has reconsidered the 

requirements for a physician’s 

statement, as well as pilot notification of 

the contents of the physician’s 

statement, and operator notification of 

intended POC use, and believes that 

these requirements are not necessary to 

maintain the safety of a passenger using 

a POC or the safe operation of the 

aircraft. The requirements for a 

physician’s statement and pilot in 

command and operator notification 

impose a significant paperwork burden 

on affected passengers and their 

physicians as well as crewmembers and 

aircraft operators that are both 

unnecessary and unreasonable. 

Accordingly, the agency proposes to 

remove these requirements. 

Physician statement: When the 

agency issued the final rule on SFAR 

No. 106, the agency anticipated the 

passenger’s physician would help the 

passenger determine their need to use 

the POC during flight (e.g., during the 

whole flight, during portions of the 

flight, or as needed). At the time of the 

SFAR No. 106 final rule, the agency also 

expected a passenger’s physician to 

verify, in a written statement, the 

passenger’s ability to operate the device 

and respond to any alarms. After 

reviewing this requirement the agency 

determined, since a passenger may only 

obtain a POC by medical prescription, a 

secondary statement regarding the need 

and the passenger’s ability to use the 

device, results in an unnecessary 

burden. 

Additionally, POC usage is the same 

on board the aircraft as any other 

location. The pressure in the aircraft 

cabin allows a POC to be used without 

changes in settings or liter flow, or other 

adjustments. Requiring passengers to 

obtain a physician’s statement 

specifying oxygen flow rate 

unnecessarily duplicates information 

provided to the passenger by the 

prescribing physician. Therefore, this 

proposal would eliminate the current 

FAA requirement for passengers to 

obtain a physician’s statement prior to 

using a POC on board an aircraft in part 

121, 125, and 135 operations.14

Pilot and aircraft operator 

notification: In the SFAR No. 106 final 

rule preamble, the FAA reasoned that 

the pilot in command should be aware 

of POC use on a flight because POC 

failure could possibly create a medical 

event requiring emergency action. 

Additionally, because some POCs may 

use electrical outlets in the cabin, the 

FAA wanted the pilot in command to be 

aware that a power restriction could 

affect POC use so that the pilot could 

make an appropriate announcement if 

the use of that power needed to be 

restricted. The SFAR No. 106 preamble 

was unclear regarding reasons for 

operator notification of intended POC 

use. 

The agency has reevaluated the 

requirement for the pilot in command to 

be informed about the contents of the 

physician’s written statement and 

determined that a requirement for any 

crewmember to review an affected 

passenger’s medical information has no 

nexus to the safety of aircraft operations. 

Further, unlike other medical oxygen 

devices for passenger use that must be 

maintained and supplied by aircraft 

operators, neither an aircraft operator 

nor its crew has any responsibility for 

the operation of the POC or the 

concentration of oxygen dispensed. The 

responsibility for the use of a 

passenger’s POC rests with the 

passenger. 

Finally, based on a review of air 

carrier safety data 15 since publication of 

SFAR No. 106, the agency has not 

identified any instances of POC 

malfunction during flight. Nevertheless, 

the agency notes that while advanced 

notice that a passenger may need 

assistance in the event of POC failure 

could be helpful to crewmembers, 

crewmembers currently receive training 

on how to respond to unanticipated 

events that may arise on board an 

aircraft, including medical events. 

Based on the foregoing discussion, the 

agency’s proposal would eliminate the 

requirement for passengers to notify the 

pilot in command of intended POC use 


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16The agency reviewed data from the following 

accident, incident and voluntary reporting 

databases: VDRP, SDRS, NTSB, ASRS and AIDS. 

and the contents of the physician’s 

statement. The same rationale applies to 

the agency’s proposal to eliminate the 

requirement for passengers to notify the 

aircraft operator of intended POC use 

during a flight. 

b. Portable Oxygen Concentrator Alarms 

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

requires a passenger using a POC on 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. These requirements 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. 

The FAA believes it is the 

responsibility of the passenger or the 

passenger’s caregiver to ensure the POC 

is operating properly and to know how 

to respond when it is not operating 

properly. The agency further believes 

removing this requirement will not 

affect aviation safety because these 

alarms are primarily intended to ensure 

the device continues to function as 

intended. The FAA also emphasizes that 

it has not identified any incidents 

regarding POC malfunctions on board 

aircraft.16 Therefore, the FAA is 

proposing to eliminate this SFAR No. 

106 requirement (section 3(b)(1)). 

c. Ensuring the Portable Oxygen 

Concentrator is Free of Petroleum 

Products 

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

the user 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. The NPRM proposing SFAR No. 

106 stated 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). 

The FAA does not believe this 

requirement is necessary to ensure safe 

POC use in the aircraft environment. 

While the agency acknowledges 

petroleum products may accelerate an 

existing fire, neither a POC nor 

concentrated oxygen produced by the 

POC would increase this risk. Further, 

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. The agency 

notes it is the passenger’s responsibility 

to maintain their POC in good condition 

so that it may function properly. 

Therefore, the agency proposes 

eliminating the SFAR No. 106 

requirement for a passenger to ensure 

their POC is in good condition (free of 

damage, excessive wear, abuse, etc.) and 

free of oil, grease, or other petroleum 

products. 

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 

an airplane. This requirement came 

from the user manual of the first POC 

approved by the FAA. The FAA believes 

it is the passenger’s responsibility to 

ensure they are using products meeting 

the manufacturer’s requirements for 

salve and lotion usage with a POC. To 

the extent SFAR No. 106 contemplated 

a petroleum-based lotion or a salve, the 

risk and responsibilities are addressed 

in the discussion pertaining to the 

elimination of the requirement for the 

user to ensure that the POC is free from 

petroleum products and associated 

risks. Therefore, the FAA is proposing 

to eliminate 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. The 

passenger must carry on the flight 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. 

The FAA believes it is the passenger’s 

responsibility to understand the 

performance of their POC and their 

POCs battery life under varying 

conditions, and further to ensure their 

POC will enable them to adhere to their 

physician’s instructions. Passengers 

who use a POC during air travel should 

carefully read the owner’s manual to 

ensure the selected model meets their 

needs. All POC user manuals have liter 

flow and battery duration charts to help 

users make informed decisions 

regarding the number of spare batteries 

to bring. Therefore, the FAA proposes to 

eliminate this SFAR No. 106 

requirement. 

The FAA notes, however, that in 

accordance with DOT regulations 

regarding assistive devices, U.S. and 

foreign carriers may still require 

passengers to carry an adequate number 

of batteries required to power the POC 

for not less than 150% of the expected 

maximum flight duration. See 14 CFR 

382.133(f)(2). 

G. Miscellaneous 

The agency proposes to update 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. 

VI. Advisory Circulars 

The FAA expects to revise the 

existing Advisory Circular pertaining to 

POC use on aircraft in part 121, 125 and 

135 operations. A draft revised Advisory 

Circular will be provided in the docket 

of this rulemaking for comment. 

VII. 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 

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 proposed rule. 


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17http://www.manta.com/. 

The agency suggests readers seeking 

greater detail read the full regulatory 

evaluation, a copy of which has been 

placed in the docket for this rulemaking. 

In conducting these analyses, FAA 

has determined that this proposed 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) 

would not have a significant economic 

impact on a substantial number of small 

entities; (5) would not create 

unnecessary obstacles to the foreign 

commerce of the United States; and (6) 

would 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 FAA estimates that the cost of the 

proposed rule would be a one-time cost 

of $22,000 incurred by manufacturers to 

modify a label and would be associated 

with costs that manufacturers would 

incur to change their current labeling 

process to affix a label with the 

proposed language on the devices. The 

FAA also estimated that manufacturers 

would save $108,000 over ten years by 

no longer having to petition the FAA for 

rulemaking to include a new Portable 

Oxygen Concentrator (POC) in the SFAR 

No. 106. The total cost savings from the 

proposed rule is $37.4 million ($26.1 

million at 7% present value and $31.8 

million at 3% present value). 

Who is potentially affected by this 

rule? 

• POC manufacturers 

• Passengers carrying POCs on board 

aircraft 

• Physicians providing written 

statements to POC users 

• Aircraft operators and crews 

Assumptions: 

• Present Value Discount rates—7% 

and 3% 

• Period of Analysis—ten years 

• 24 new POCs over ten years 

Benefits of This Rule 

With the elimination of the SFAR and 

the replacement with a process where 

the manufacturers self-certify based on 

meeting the acceptance criteria 

described in the rule and label the 

devices, manufacturers would be able to 

introduce new POCs sooner to the 

market. Therefore, one benefit of this 

rule would be to eliminate delays and 

enable manufacturers to bring their 

devices to market sooner. 

Furthermore, the proposed rule would 

result in cost savings because the pilot 

in command would no longer have to be 

notified when an affected passenger 

intends to use a POC on the aircraft and 

be informed about the contents of the 

physician’s written statement. The 

proposed rule would also result in 

additional cost savings because affected 

passengers would no longer have to 

obtain a physician’s written statement, 

as a prerequisite to bringing POCs on 

board aircraft in part 121, 125, and 135 

operations. 

The cost savings of this proposal are 

summarized in the table below. 

Costs of This Rule 

The industry would incur costs of 

$22,000 to modify labels that they 

already affix to the POC, to contain the 

language proposed by this rule. The 

industry cost savings of $108,000 by no 

longer having to petition the FAA for 

each new device easily exceed the 

labeling costs. 

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. 

The FAA identified nine companies 

that produce portable oxygen 

concentrators for use on 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 on-line research, the FAA 

found data 17 indicating that six of the 

nine manufacturers are small entities 

and concludes 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 they will be able to market new 

portable oxygen concentrators sooner. 


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18A sixth manufacturer that was contacted 

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

not a small business. 

Although a substantial number of 

operators conducting part 121, 125 and 

135 operations are small entities, all 

part 121, 125 and 135 operators are 

expected to experience cost savings 

because the proposal would no longer 

require the pilot in command 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 proposed rule is expected to 

reduce burdens that SFAR No. 106 

currently imposes on the Portable 

Oxygen Concentrator (POC) 

manufacturers. This NPRM would 

impose small costs on manufacturers by 

requiring a label indicating the device 

meets FAA requirements for use on 

board aircraft. The FAA learned from 

five of the small manufacturers that they 

might incur a one-time cost ranging 

from $200 to $1,500 or $0.20 to $1 per 

label.18 These costs would be offset by 

cost savings from the elimination of 

having to petition for rulemaking and 

await a final regulatory action. One 

manufacturer stated these cost savings 

are worth $4,500 for each petition. 

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. 

The FAA solicits comments regarding 

this determination. 

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 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 proposed rule 

and determined that it would 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 

$151.0 million in lieu of $100 million. 

This proposed 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 would 

be no new requirements for information 

collection associated with this proposed 

rule. 

This rule proposes to discontinue the 

requirements quantified in FAA 

information collection 2120–0702, Use 

of Certain Personal Oxygen 

Concentrator (POC) Devices on Board 

Aircraft. The agency addressed the 

reasons for the discontinuance of this 

collection in the preamble discussion 

regarding the substantive provisions of 

the proposal. 

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 International Civil Aviation 

Organization (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 (ICAO TI). 

ICAO TI does not contain specific 

provisions for POCs but Part 8 

(passenger and crew exceptions) allows 

for their carriage on board aircraft as 

portable medical electronic devices 

subject to certain conditions. The 

conditions in Part 8 pertaining to 

batteries used to power POCs are similar 

to the allowances given in 49 CFR 

175.10(a)(18). 

G. Executive Order 13609, Promoting 

International Regulatory Cooperation 

Executive Order 13609, Promoting 

International Regulatory Cooperation, 

(77 FR 26413 (May 4, 2012)) promotes 

international regulatory cooperation to 

meet shared challenges involving 

health, safety, labor, security, 

environmental, and other issues and to 

reduce, eliminate, or prevent 

unnecessary differences in regulatory 

requirements. The FAA has analyzed 

this action under the policies and 

agency responsibilities of Executive 

Order 13609, and has determined that 

this action would have no effect on 

international regulatory cooperation. 

H. Environmental Analysis 

FAA Order 1050.1E identifies FAA 

actions that are categorically excluded 

from preparation of an environmental 

assessment or environmental impact 

statement under the National 

Environmental Policy Act in the 

absence of extraordinary circumstances. 

The FAA has determined this 

rulemaking action qualifies for the 

categorical exclusion identified in 

paragraph 312f and involves no 

extraordinary circumstances. 

VIII. Executive Order Determinations 

A. Executive Order 13132, Federalism 

The FAA has analyzed this proposed 

rule under the principles and criteria of 

Executive Order 13132, Federalism. The 

agency has determined that this action 

would 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, would not have Federalism 

implications. 

B. Executive Order 13211, Regulations 

That Significantly Affect Energy Supply, 

Distribution, or Use 

The FAA analyzed this proposed 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 would not 

be a ‘‘significant energy action’’ under 

the executive order and would not be 

likely to have a significant adverse effect 

on the supply, distribution, or use of 

energy. 

IX. Additional Information 

A. Comments Invited 

The FAA invites interested persons to 

participate in this rulemaking by 

submitting written comments, data, or 

views. The agency also invites 


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56302 Federal Register / Vol. 79, No. 182 / Friday, September 19, 2014 / Proposed Rules 

comments relating to the economic, 

environmental, energy, or federalism 

impacts that might result from adopting 

the proposals in this document. The 

most helpful comments reference a 

specific portion of the proposal, explain 

the reason for any recommended 

change, and include supporting data. To 

ensure the docket does not contain 

duplicate comments, commenters 

should send only one copy of written 

comments, or if comments are filed 

electronically, commenters should 

submit only one time. 

The FAA will file in the docket all 

comments it receives, as well as a report 

summarizing each substantive public 

contact with FAA personnel concerning 

this proposed rulemaking. Before acting 

on this proposal, the FAA will consider 

all comments it receives on or before the 

closing date for comments. The FAA 

will consider comments filed after the 

comment period has closed if it is 

possible to do so without incurring 

expense or delay. The agency may 

change this proposal in light of the 

comments it receives. 

Proprietary or Confidential Business 

Information: Commenters should not 

file proprietary or confidential business 

information in the docket. Such 

information must be sent or delivered 

directly to the person identified in the 

FOR FURTHER INFORMATION CONTACT

section of this document, and marked as 

proprietary or confidential. If submitting 

information on a disk or CD ROM, mark 

the outside of the disk or CD ROM, and 

identify electronically within the disk or 

CD ROM the specific information that is 

proprietary or confidential. 

Under 14 CFR 11.35(b), if the FAA is 

aware of proprietary information filed 

with a comment, the agency does not 

place it in the docket. It is held in a 

separate file to which the public does 

not have access, and the FAA places a 

note in the docket that it has received 

it. If the FAA receives a request to 

examine or copy this information, it 

treats it as any other request under the 

Freedom of Information Act (5 U.S.C. 

552). The FAA processes such a request 

under Department of Transportation 

procedures found in 49 CFR part 7. 

B. Availability of Rulemaking 

Documents 

An electronic copy of rulemaking 

documents may be obtained from the 

Internet by— 

• Searching the Federal eRulemaking 

Portal at http://www.regulations.gov; 

• Visiting the FAA’s Regulations and 

Policies Web page at http://

www.faa.gov/regulations_policies or 

• Accessing the Government Printing 

Office’s Federal Digital System at 

http://www.gpo.gov/fdsys/. 

Copies may also be obtained by 

sending a request to the Federal 

Aviation Administration, Office of 

Rulemaking, ARM–1, 800 Independence 

Avenue SW., Washington, DC 20591, or 

by calling (202) 267–9680. Commenters 

must identify the docket or notice 

number of this rulemaking. 

All documents the FAA considered in 

developing this proposed rule, 

including economic analyses and 

technical reports, may be accessed from 

the Internet through the Federal 

eRulemaking Portal referenced above. 

List of Subjects 

14 CFR Part 1 

Air transportation. 

14 CFR Part 121 

Air carriers, Aircraft, Aviation safety, 

Charter flights, Incorporation by 

reference, Safety, Transportation. 

14 CFR Part 125 

Aircraft, Aviation safety, 

Incorporation by reference. 

14 CFR Part 135 

Air taxis, Aircraft, Aviation safety, 

Incorporation by reference. 

The Proposed Amendment 

In consideration of the foregoing, the 

Federal Aviation Administration 

proposes to amend chapter I of title 14, 

Code of Federal Regulations as follows: 

PART 1—DEFINITIONS AND 

ABBREVIATIONS 

■ 1. The authority citation for part 1 is 

revised 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. 

* * * * * 

PART 121—OPERATING 

REQUIREMENTS: DOMESTIC, FLAG, 

AND SUPPLEMENTAL OPERATIONS 

■ 3. The authority citation for part 121 

continues to read as follows: 

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

40119, 41706, 44101, 44701–44702, 44705, 

44709–44711, 44713, 44716–44717, 44722, 

44732, 46105; Pub. L. 111–216, 124 Stat. 

2348 (49 U.S.C. 44701 note); Pub. L. 112–95, 

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

Special Federal Aviation Regulation 

No. 106 [Removed] 

■ 4. Remove Special Federal Aviation 

Regulation No. 106. 

■ 5. Amend § 121.306 as follows: 

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

following the semi-colon; 

■ 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 of this part; or 

* * * * * 

■ 6. Amend § 121.574 as follows: 

■ A. Revise 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 paragraphs (e) and (f). 

The revisions and additions read as 

follows: 

§ 121.574 Oxygen and portable oxygen 

concentrators for medical use by 

passengers. 

(a) Except as provided in paragraph 

(e) of this section, a certificate holder 

may allow a passenger to carry and 

operate equipment for the storage, 

generation, or dispensing of oxygen 

when the following conditions are met: 

* * * * * 

(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) A passenger may carry and operate 

a portable oxygen concentrator for 

personal use and a certificate holder 

may allow a passenger to carry and 

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 following requirements: 


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(1) Is legally marketed in the United 

States in accordance with Food and 

Drug Administration requirements in 

title 21 of the CFR; 

(2) Meets the standards of RTCA DO– 

160G, Environmental Conditions and 

Test Procedures for Airborne 

Equipment, Section 21, Category M 

issued December 8, 2010; 

(3) Generates a maximum oxygen 

pressure of less than 200 kPa gauge 

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

(4) Does not contain any hazardous 

materials subject to the Hazardous 

Materials Regulations (49 CFR parts 

171–180) except as provided in 49 CFR 

175.10; and 

(5) 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 

portable oxygen concentrator has 

determined this device conforms to all 

applicable FAA requirements for 

portable oxygen concentrator carriage 

and use on board aircraft.’’ The label 

requirements in this paragraph do not 

apply to the following portable oxygen 

concentrators approved by the FAA for 

use on board aircraft prior to [DATE 90 

DAYS AFTER DATE OF PUBLICATION 

OF FINAL RULE IN THE FEDERAL 

REGISTER]: 

(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. 

(f) Incorporation by reference. RTCA 

DO–160G, Environmental Conditions 

and Test Procedures for Airborne 

Equipment, Section 21, Category M 

issued December 8, 2010 is incorporated 

by reference into this section with the 

approval of the Director of the Office of 

the Federal Register in accordance with 

5 U.S.C. 552(a) and 1 CFR part 51. To 

enforce any edition other than that 

specified in this section, the Federal 

Aviation Administration must publish 

notice of change in the Federal Register 

and the material must be available to the 

public. Copies of this standard may be 

obtained from RTCA, Inc. 1150 18th 

Street NW., Suite 910, Washington, DC 

20036; telephone (202) 833–9339; 

www.rtca.org/store_list.asp. This 

standard is available for inspection at 

the Office of Rulemaking (ARM–1), 

Federal Aviation Administration, 800 

Independence Avenue SW., 

Washington, DC 20591; telephone (202) 

267–9677. It is also available for 

inspection at the National Archives and 

Records Administration (NARA). For 

information on the availability of this 

material at NARA, call (202) 741–6030 

or go to http://www.archives.gov/

federal_register/code_of_federal_

regulations/ibr_locations.html. 

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 

■ 7. 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] 

■ 8. Remove Special Federal Aviation 

Regulation No. 106. 

■ 9. Amend § 125.204 as follows: 

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

following the semi-colon; 

■ 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) * * * 

(5) Portable oxygen concentrators that 

comply with the requirements in 

§ 125.219 of this part; or 

* * * * * 

■ 10. Amend § 125.219 as follows: 

■ A. Revise section heading; 

■ B. Revise paragraph (a) introductory 

text; 

■ C. In paragraph (a)(3) remove the 

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

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

■ D. Revise paragraph (b); and 

■ E. Add paragraphs (f) and (g). 

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), (e) 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 unit to be 

carried is constructed so that all valves, 

fittings, and gauges are protected from 

damage during that carriage or operation 

and unless the following conditions are 

met: 

* * * * * 

(b) No person may smoke or crate 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) A passenger may carry and operate 

a portable oxygen concentrator for 

personal use and a certificate holder 

may allow a passenger to carry and 

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 following requirements: 

(1) Is legally marketed in the United 

States in accordance with Food and 

Drug Administration requirements in 

title 21 of the CFR; 

(2) Meets the standards of RTCA DO– 

160G, Environmental Conditions and 

Test Procedures for Airborne 

Equipment, Section 21, Category M 

issued December 8, 2010; 

(3) Generates a maximum oxygen 

pressure of less than 200 kPa gauge 

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

(4) Does not contain any hazardous 

materials subject to the Hazardous 

Materials Regulations (49 CFR parts 

171–180) except as provided in 49 CFR 

175.10; and 

(5) 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 

portable oxygen concentrator has 

determined this device conforms to all 

applicable FAA requirements for 

portable oxygen concentrator carriage 


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56304 Federal Register / Vol. 79, No. 182 / Friday, September 19, 2014 / Proposed Rules 

and use on board aircraft.’’ The label 

requirements in this paragraph do not 

apply to the following portable oxygen 

concentrators approved by the FAA for 

use on board aircraft prior to [DATE 90 

DAYS AFTER DATE OF PUBLICATION 

OF FINAL RULE IN THE Federal 

Register]: 

(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 

(xiv) VBox Trooper Oxygen 

Concentrator. 

(g) Incorporation by reference. RTCA 

DO–160G, Environmental Conditions 

and Test Procedures for Airborne 

Equipment, Section 21, Category M 

issued December 8, 2010 is incorporated 

by reference into this section with the 

approval of the Director of the Office of 

the Federal Register in accordance with 

5 U.S.C. 552(a) and 1 CFR part 51. To 

enforce any edition other than that 

specified in this section, the Federal 

Aviation Administration must publish 

notice of change in the Federal Register 

and the material must be available to the 

public. Copies of this standard may be 

obtained from RTCA, Inc. 1150 18th 

Street NW., Suite 910, Washington, DC 

20036; telephone (202) 833–9339; 

www.rtca.org/store_list.asp. This 

standard is available for inspection at 

the Office of Rulemaking (ARM–1), 

Federal Aviation Administration, 800 

Independence Avenue SW., 

Washington, DC 20591; telephone (202) 

267–9677. It is also available for 

inspection at the National Archives and 

Records Administration (NARA). For 

information on the availability of this 

material at NARA, call (202) 741–6030 

or go to http://www.archives.gov/

federal_register/code_of_federal_

regulations/ibr_locations.html. 

PART 135—OPERATING 

REQUIREMENTS: COMMUTER AND 

ON DEMAND OPERATIONS AND 

RULES GOVERNING PERSONS ON 

BOARD SUCH AIRCRAFT 

■ 11. 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, 45101–45105. 

Special Federal Aviation Regulation 

No. 106 [Removed] 

■ 12. Remove Special Federal Aviation 

Regulation No. 106. 

■ 13. Amend § 135.91 as follows: 

■ A. Revise paragraph (a) introductory 

text; 

■ B. In paragraph (a)(3) remove the 

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

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

■ C. Revise paragraph (b); and 

■ D. Add paragraphs (f) and (g). 

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), (e) 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 unit to be 

carried is constructed so that all valves, 

fittings, and gauges are protected from 

damage during that carriage or operation 

and unless the following conditions are 

met— 

* * * * * 

(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) A passenger may carry and operate 

a portable oxygen concentrator for 

personal use and a certificate holder 

may allow a passenger to carry and 

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 following requirements: 

(1) Is legally marketed in the United 

States in accordance with Food and 

Drug Administration requirements in 

title 21 of the CFR; 

(2) Meets the standards of RTCA DO– 

160G, Environmental Conditions and 

Test Procedures for Airborne 

Equipment, Section 21, Category M 

issued December 8, 2010; 

(3) Generates a maximum oxygen 

pressure of less than 200 kPa gauge 

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

(4) Does not contain any hazardous 

materials subject to the Hazardous 

Materials Regulations (49 CFR parts 

171–180) except as provided in 49 CFR 

175.10; and 

(5) 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 

portable oxygen concentrator has 

determined this device conforms to all 

applicable FAA requirements for 

portable oxygen concentrator carriage 

and use on board aircraft.’’ The label 

requirements in this paragraph do not 

apply to the following portable oxygen 

concentrators approved by the FAA for 

use on board aircraft prior to [DATE 90 

DAYS AFTER DATE OF PUBLICATION 

OF FINAL RULE IN THE Federal 

Register]: 

(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. 

(g) Incorporation by reference. RTCA 

DO–160G, Environmental Conditions 

and Test Procedures for Airborne 

Equipment, Section 21, Category M 

issued December 8, 2010 is incorporated 

by reference into this section with the 

approval of the Director of the Office of 

the Federal Register in accordance with 

5 U.S.C. 552(a) and 1 CFR part 51. To 

enforce any edition other than that 

specified in this section, the Federal 

Aviation Administration must publish 

notice of change in the Federal Register 

and the material must be available to the 


asabaliauskas on DSK5VPTVN1PROD with PROPOSALS
Federal Register / Vol. 79, No. 182 / Friday, September 19, 2014 / Proposed Rules 56305 

public. Copies of this standard may be 

obtained from RTCA, Inc. 1150 18th 

Street NW., Suite 910, Washington, DC 

20036; telephone (202) 833–9339; 

www.rtca.org/store_list.asp. This 

standard is available for inspection at 

the Office of Rulemaking (ARM–1), 

Federal Aviation Administration, 800 

Independence Avenue SW., 

Washington, DC 20591; telephone (202) 

267–9677. It is also available for 

inspection at the National Archives and 

Records Administration (NARA). For 

information on the availability of this 

material at NARA, call (202) 741–6030 

or go to http://www.archives.gov/

federal_register/code_of_federal_

regulations/ibr_locations.html. 

■ 14. Amend § 135.144 as follows: 

■ A. In paragraph (a) introductory text, 

remove ‘‘of the following’’; 

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

following the semi-colon; 

■ 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 of this part; or 

* * * * * 

Issued under the authority provided by 49 

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

DC, on September 9, 2014. 

John S. Duncan, 

Director, Flight Standards Service. 

[FR Doc. 2014–21964 Filed 9–18–14; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF THE TREASURY 

Internal Revenue Service 

26 CFR Part 1 

[REG–111839–13] 

RIN 1545–BL62 

Transitional Amendments To Satisfy 

the Market Rate of Return Rules for 

Hybrid Retirement Plans 

AGENCY: Internal Revenue Service (IRS), 

Treasury. 

ACTION: Notice of proposed rulemaking 

and notice of public hearing. 

SUMMARY: This document contains 

proposed regulations that would 

provide guidance regarding certain 

amendments to applicable defined 

benefit plans. Applicable defined 

benefit plans are defined benefit plans 

that use a lump sum-based benefit 

formula, including cash balance plans 

and pension equity plans, as well as 

other hybrid retirement plans that have 

a similar effect. These proposed 

regulations would permit an applicable 

defined benefit plan that does not 

comply with the requirement that the 

plan not provide for interest credits (or 

equivalent amounts) at an effective rate 

that is greater than a market rate of 

return to comply with that requirement 

by changing to an interest crediting rate 

that is permitted under the final hybrid 

plan regulations, without violating the 

anti-cutback rules of section 411(d)(6). 

These regulations would affect 

sponsors, administrators, participants, 

and beneficiaries of these plans. This 

document also provides a notice of a 

public hearing on these proposed 

regulations. 

DATES: Written or electronic comments 

must be received by December 18, 2014. 

Outlines of topics to be discussed at the 

public hearing scheduled for January 9, 

2015, at 10 a.m. must be received by 

December 18, 2014. 

ADDRESSES: Send submissions to: 

CC:PA:LPD:PR (REG–111839–13), Room 

5203, Internal Revenue Service, P.O. 

Box 7604, Ben Franklin Station, 

Washington, DC 20044. Submissions 

may be hand-delivered Monday through 

Friday between the hours of 8 a.m. and 

4 p.m. to: CC:PA:LPD:PR (REG–111839– 

13), Courier’s Desk, Internal Revenue 

Service, 1111 Constitution Avenue NW., 

Washington, DC, or sent electronically, 

via the Federal eRulemaking Portal at 

http://www.regulations.gov (IRS REG– 

111839–13). The public hearing will be 

held in the IRS Auditorium, Internal 

Revenue Building, 1111 Constitution 

Avenue NW., Washington, DC. 

FOR FURTHER INFORMATION CONTACT: 

Concerning the regulations, Neil S. 

Sandhu or Linda S. F. Marshall at (202) 

317–6700; concerning submissions of 

comments, the hearing, and/or being 

placed on the building access list to 

attend the hearing, Oluwafunmilayo 

(Funmi) Taylor at (202) 317–6901 (not 

toll-free numbers). 

SUPPLEMENTARY INFORMATION: 

Background 

I. In General 

This document contains proposed 

amendments to the Income Tax 

Regulations (26 CFR part 1) under 

section 411(b)(5) of the Internal Revenue 

Code (Code). 

Generally, a defined benefit pension 

plan must satisfy the requirements of 

section 411 in order to be qualified 

under section 401(a) of the Code. 

Section 411(b)(5), which modifies the 

accrual requirements of section 411(b), 

was added to the Code by section 701(b) 

of the Pension Protection Act of 2006, 

Public Law 109–280 (120 Stat. 780 

(2006)) (PPA ’06). Section 411(b)(5) and 

certain related effective date provisions 

were subsequently amended by the 

Worker, Retiree, and Employer Recovery 

Act of 2008, Public Law 110–458 (122 

Stat. 5092 (2008)) (WRERA ’08). 

Under section 411(b)(5)(B)(i), a 

statutory hybrid plan is treated as failing 

to satisfy the requirements of section 

411(b)(1)(H) (which provides that the 

rate of an employee’s benefit accrual 

must not be reduced because of the 

attainment of any age) if the terms of the 

plan provide any interest credit (or an 

equivalent amount) for any plan year at 

a rate that is in excess of a market rate 

of return. Section 411(b)(5)(B)(i) is 

generally effective for plan years 

beginning after December 31, 2007. 

Section 411(d)(6) provides generally 

that a plan does not satisfy section 411 

if an amendment to the plan decreases 

a participant’s accrued benefit. For this 

purpose, a plan amendment that has the 

effect of eliminating or reducing an 

early retirement benefit or a retirementtype subsidy or eliminating an optional 

form of benefit with respect to benefits 

attributable to service before the 

amendment is treated as reducing 

accrued benefits. 

Sections 204(b)(5)(B)(i) and 204(g) of 

the Employee Retirement Income 

Security Act of 1974, Public Law 93– 

406 (88 Stat. 829 (1974)), as amended 

(ERISA), contain rules that are parallel 

to sections 411(b)(5)(B)(i) and 411(d)(6), 

respectively. Under section 101 of 

Reorganization Plan No. 4 of 1978 (43 

FR 47713), the Secretary of the Treasury 

has interpretive jurisdiction over the 

subject matter addressed in these 

proposed regulations for purposes of 

ERISA, as well as the Code. Thus, these 

proposed regulations would apply for 

purposes of sections 411(b)(5)(B)(i) and 

411(d)(6) of the Code, as well as for 

purposes of sections 204(b)(5)(B)(i) and 

204(g) of ERISA. 

Section 1.411(d)–4, A–2(b)(1), of the 

Income Tax Regulations provides, in 

part, that the Commissioner may, 

consistent with the provisions of 

§ 1.411(d)–4, provide for the elimination 

or reduction of section 411(d)(6) 

protected benefits that have already 

accrued to the extent that such 

elimination or reduction is necessary to 

permit compliance with other 

requirements of section 401(a). The 

Commissioner may exercise this 

authority only through the publication 


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