U.S. Department or·rransportation 

FEDERAL AVIATION 

ADMINISTRATION 

NOTICE OF PROPOSED RULEMAKING 

REGULATORY EVALUATION 

[Acceptance Criteria for Portable Oxygen Concentrators Used On 

Board Aircraft] 

[14 CFR Parts 1, 121, 125, and 135] 

Carole Gaelick 

OFFICE OF AVIATION POLICY AND PLANS 

ECONOMIC ANALYSIS DIVISION 

July 2014 
Table of Contents 

List of Abbreviations and Definitions .............................................................................................. 2 

Executive Sun11nary ......................................................................................................................... 3 

I. Introduction ....................................................................................................................... 3 

II. Discussion of the Proposed Rule ...................................................................................... 5 

Ill. Benefits ............................................................................................................................. 7 

IV. Costs ................................................................................................................................ l4 

V. Net Benefits .................................................................................................................... l 4 

Page 1 
List of Abbreviations and Definitions 

FAA- Federal Aviation Administration 

FDA - Food and Drug Administration 

PHMSA- Pipeline and Hazardous Materials Safety Administration 

POC - Portable Oxygen Concentrator 

RTCA - Radio Technical Commission for Aeronautics 

SFAR - Special Federal Aviation Regulation 

Page 2 
Executive Summary 

The FAA is proposing a rule to replace current Special Federal Aviation Regulation (SF AR) No. 

106. The FAA is proposing to eliminate the current process by which portable oxygen 

concentrator (POC) manufacturers have their devices approved by the FAA for use on aircraft 

and replace it with a process by which manufacturers make the determination that the device 

meets certain acceptance criteria in this proposal and affix a label indicating the device may be 

used on board aircraft. By far the largest savings v,rould accrue to the airlines as the pilot-incommand would no longer have to be notified when a passenger brings a POC onboard and be 

informed about the contents of the physician's statement and the user would no longer have to 

allow the crew to review the physician's statement. This change to the SF AR No. I 06 process is 

expected to result in cost savings of $3 7 million just to the airlines over a I 0 year time period. 

Total cost savings are presented in the table below. 

Total Cost Savings from Proposed Rule 

Cost Savings 

FAA Savings- No SFAR 

Manufacturer Savings- No Petition 

No Longer Obtaining Physician's stat ement 

No Longer Notifying Pilot in Command 

Total Cost Savings 

I. Introduction 

$ 91,644 

$108,000 

$559,660 

$36,599,268 

$37,358,571 

7% present 3% present 

value savings 

$ 68,871 

$75,853 

$391,402 

$25,595,997 

$26,132,U3 

value savings 

$ 32,573 

$92,126 

$476,509 

$31,161,620 

$31,762,828 

The proposed rule would replace the current Special Federal Aviation Regulation (SF AR) No. 

106 which prescribes the existing Federal Aviation Administration (FAA) process required for 

aircraft passenger use of portable oxygen concentrators (POC) during a flight in air carrier 

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operations, commercial operations and certain other operations using large aircraft. Today the 

FAA assesses each POC on a case-by-case basis to detem1ine whether it is safe for use on board 

aircraft. If the FAA determines that a POC is safe for use on board aircraft. the specific POC 

model is identified in the Code of Federal Regulations through rulemaking. The rulemaking 

process introduces delays for manufacturers who may have to wait for FAA approval sometimes 

as long as up to two years, before the device can be marketed. Manufacturers incur 

administrative costs in complying with the SF AR and interacting with the FAA during the 

process. This rule proposes eliminating SF AR No. I 06 and requiring POCs intended for use on 

board aircraft to satisfy FAA acceptance criteria. The manufacturer would not have to interact 

with the FAA in order for the POC to be certified, but would in essence be self-certifying. This 

proposal would require POC manufacturers to affix a label to the POC to certify compliance with 

the acceptance criteria. The label would provide a recogni zable means for crewmembers and 

passengers to identify POCs that satisfy the acceptance criteria. POCs currently approved for 

use on board aircraft by the FAA would continue to be identified in the Code of Federal 

Regulations as approved for use on board aircraft and would not require a label. 

In addition, this proposal would eliminate requirements in SF AR No. I 06 that are currently 

addressed elsewhere in the Code of Federal Regulations and remove requirements that are not 

necessary for aviation safety. By doing so, it would relieve regulatory burdens for, airlines, 

passengers and physicians. Even though the time-to-complete the physician's statement and 

informing the pilot-in-command about a passenger boarding with a POC are not time intensive, 

these actions result in substantial costs because of their frequency of occurrence resulting in 

substantial costs. These cost savings are discussed in detail below. 

Page 4 
H. Discussion of the Proposed Rule 

The rule proposes that a passenger may carry and operate a POC for personal use and a 

certificate holder may allow a passenger to carry and operate a POC on board an aircraft 

operated under this part during all phases of flight if the POC satisfies all of the following 

requirements: 

(I ) Is legally marketed in the United States in accordance with Food and Drug 

Administration requirements in title 21; 

(2) Meets the standards of RTCA D0-160G, Environmental Conditions and Test 

Procedures for Airborne Equipment, Section 21, Category M issued December 8, 

20 10; 

(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 I lazardous Materials 

Rc!!.ulations ( 49 CFR parts 171- 180) except as provided in 49 CFR 175.1 0; and 

(5) Bears a label on the exterior of the device that remains affixed for the life of the 

device and contains 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.." 

Page 5 
The label requirements do not apply to the POCs that have already been approved by the FAA 

for use onboard aircraft by the date indicated in the proposed rule text. These devices are listed 

in the proposed rule text. 

In accordance with this proposal, manufacturers of POC models which are not already identified 

in SF AR No. I 06 would have to ensure that the POC satisfies the FAA acceptance criteria before 

their POC 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. The manufacturer would have to affix a label 

to the POC, as specified in the proposed regulation. The label would indicate that the POC 

meets FAA requirements for use on board aircraft. The FAA believes the label would facilitate 

passenger and crew recognition that the POC is safe for use in the cabin during all phases of 

flight. As will be discussed below, the requirement for a label would result in low to minimal 

costs, while the removal of the requirement for the manufacturer to demonstrate to the FAA that 

their devices meet the acceptance criteria in SF AR No. 106 would reduce the delay in bringing 

the device to market and the administrative costs associated with demonstrating to the FAA that 

the device meets the criteria specified in SF AR 106. 

The proposed FAA acceptance criteria are simi Jar to the approval requirements found in SF AR 

No. 106 with some exceptions. One exception is the proposed label which is not currently 

required by SF AR 106. 1 Based on discussions with manufacturers, the FAA expects these costs 

to be small. The second exception is the proposal that the device must meet the RTCA standards 

indicated above in place of the general requirement for operators to ensure that the device does 

not cause interference with aircraft equipment. Based on a review ofPOC EMI testing results 

1 Under the current regulatory regime, those devices that have been approved for use on aircraft by the FAA are 

listed in the SFAR, and airlines check the list before allowing the device on board the aircraft. 

Page 6 
provided to the agency. the FAA has determined that all manufacturers currently complete 

testing in accordance with RTCA standard 1600. Section 21 , Category M. All devices listed in 

the SF AR have met these RTCA standards (or an earlier but equivalent standard). 

III. Benefits 

The proposed rule would provide relief to manufacturers, the FAA, passengers, airlines and 

physicians. It would provide relief to manufacturers and the FAA by eliminating the SF AR 

process, to physic ians and passengers by no longer requiring a physician's statement, and to 

airlines by no longer requiring pilot notification. 

In the tables that follow in this report, year 0 represents 2014, the year this report is published. 

There may be slight discrepancies due to roundi ng error in some tables. 

Under this proposal. manufacturers should be able to more quickly market a new POC that meets 

FAA requirements for use on board aircraft. The manufacturer would no longer have to submit 

documents to the F /\A verifying the device meets SF AR No.I 06 requirements and would no 

longer have to wait for the FAA, to verify that the POC meets the requirements and to amend 

SF AR No.I 06, a rulemaking process that might take over a year. One manufacturer estimates 

cost savings of $4,500 2 from each petition for rulemaking they would no longer have to submit. 

There have been 24 POCs added to SF AR No. I 06 since 2005. Assuming 24 new POCs are 

introduced over the next ten years, the proposal could save the POC manufacturing industry 

$ 108,000. 3 

1 Not including the cost of the FDA approval to legally market the device, RTCA testing. and PHMSA 

determination Jetter. This estimate comes from one of the manufacturers. Others referred to reduced delays in 

introducing product to market and lost revenues. 

J $4,500 X 24 = $) 08,000 

Page 7 
The f AA received feedback from the POC manufacturing industry indicating that the delays 

manufacturers encounter while waiting for their POC device to be approved during the SF AR 

process put them at a competitive disadvantage relative to other manufacturers whose devices 

have already been approved and the delay might cost the manufacturer millions of dollars in lost 

revenues. Therefore, another benefit of this rule would be to eliminate these delays and enable 

manufacturers to bring their devices to market sooner. 

Similarly, the FAA would no longer have to expend resources to review the packages from the 

manufacturers and to update the SF AR. The FAA estimates that it incurs costs of $3,819 per 

POC in the review and approval process. Assuming 24 new POCs would be introduced over the 

next ten years, the proposal could save the FAA $91,644. 

The proposed rule would 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. In addition, 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. To estimate the burden li ~ the FAA first explains how \Ve 

derived the number of passengers with POCs. Then we provide the burdened wage rates for the 

affected professionals. With that basis, the estimated cost savings is discussed first for 

physicians and then airline crews. 

The FAA then estimated the number of POC users expected to take commercial flights. The 

National Home Oxygen Patients Association indicates on its website that there are more than one 

Page 8 
million supplementary oxygen users in the United States 

4 and the University of Southern 

California Medical Center estimated 1.5 million supplemental oxygen users in the U.S. 5 To be 

conservative we assume that there are one million supplementary oxygen users in the U.S, of 

which some subset will fly with a POC. The Freedom to Travel study 6 released by the Bureau 

ofTranspm1ation statistics indicated that people with disabilities represented over 53 million 

people in the U.S. This is about 18% of the U.S. population the year the study was released. 7 

Assuming the percent of the U.S. population that is disabled remains constant, we estimate 

approximately 57.3 million disabled people in the U.S. in 2012. According to the Annual 

Report for 2012 on Disability Related Air Travel Complaints there were approximately 20 

million people with disabilities who travelled by air in 201 2. 8 Dividing 20 million by 57 

million the FAA estimates that about 35% of persons with disabilities travel by air. If we 

assume that those medical oxygen users travel on commercial airlines at the same rate as all 

persons with disabilities, we estimate that 350,000 people needing supplemental oxygen 

travelled by air in 20 12. Assuming that the population of people who fly with POCs increases at 

the rate of the U.S. population.9 the FAA estimated the population of passengers traveling with 

roes will be 355,4 11 in 2014. The table below projects rOC passengers if that population 

increases at the same rate as the U.S. population growth rate (20 14 estimate). 

The burdened wage rates in 2012 dollars for the affected professionals are presented in the table 

below (Table I). 

4 www.homeoxygen.org 

5 www .uc O~ea lth.orgleducation/supplemental_ oxygen/more _resources/ 

c. Freedom to Travel. Bureau of Transportation Statistics, U.S. DOT, 2003 7 The U.S. population was just over 290 million in July 2003. 8 Annual Report for 2012 on Disability-Related Air Travel Complaints, which refers to estimates of number of 

disabled who travelled by air in 200 1/2002 from data obtained from the National Household Travel Survey and 

using enplanements in the intervening years to project that one can assume that over 20 mi ll ion persons with 

disabilities travelled by air in 201 2. 

9 According to the CIA World Fact book the U.S. population is increasing at the rate of .77%. 

Page 9 
Table 1 Wage Rates Used in tbe Analysis 

Job Category Hourly wage (8) Overhead Total 

Flight Attendant (1)(2) $24.83 $4.22 $29.05 

Pilot in Command (3)(4) $126.89 S21.5i $148.46 

Physician (5) $90.00 $15.30 $105.30 

Wage Multiplier 

Wage Multiplier (6)(7) 1.17 

( 1} http://www .bls.gov I ooh/tra nsportation-and· materia I· moving/flight-att end a nts.htm11tab-1 

(2} Estimate flight attendants work 1500 hours per year, based on attendants typically flying 90 hours a month and spending 50 hours a 

month on the ground, source BLS 

( 3) http://www .bls.gov I ooh/tra nsportation-and-material-moving/ airl ine-and-commercial· pi lots. htm 

(4) Based on pilot working an average 900 hours per year. 

(5) http://www .bls.gov/ ooh/healthca re/ physicians-and-surgeons. htm 

(6) Memorandum on Estimating Total Costs of compensation Based on Wage Rates or Salaries, U.S. Department of Transportation, 

January 30, 2014. 

(7) Wage multiplier for salaried employees 

(8) Wage Rates are in 2012 dollars 

Table 2 presents the assumptions 10 and estimates used in the subsequent analysis. 

Table 2 Assumpt ions and Estim01t es Used in the An:~lysis 

Number of medical oxygen users (1) 1,000,000 

Number of people with disabilities in u.s. in 2003 [2) 53,000,000 

U.S. population July 1, 2003 [3] 290,110,000 

Disabled as Percent of U.S. Population in 2003 (rounded to nearest%) 18% 

u.s. population July 1, 2012 (3] 313,910,000 

Number of people with disabilities who travelled by air in 2012 (4] 20,000,000 

Estimated Number of people with disabilities in the U.S. In 2012 (5] 56,503,800 

Estimated % of disabled who travel by air In 2012 (rounded to nearest%) 35% 

Estimated passengers with POCs In 2012 (6)(7) 350,000 

Population growth rate in U.S. (8] 0.77% 

Estimated number of passengers with POCs In 2014 355,411 

Number of enplanements per passenger per year (9) 2 

(1] National Home Oxygen Patients Association 

(2) "Freedom to Travel, pg. 2, u.s. Department of Transportation, Bureau of Transportation Statistics, 2003 

(3] U.S. Population by Year, http:/ /www.multpl.com/united-states-populatlon/table 

(4] Source Annual Report for 2012 on Disability-Related Air Travel Complaints, pg. 4, Report of the Secretary of 

Transportation to the U.S. Congress, February 2014 

(5] Assumes people with disabilities is the same percent of U.S. Population in 2012 as in 2003 

{6] Assumes users of medical oxygen fly at the same rate as the disabled populat•on. 

(7] The FAA assumes that all medical oxygen users who fly will carry a POC. This may overestimate the II of passengers 

with POC because some may rent oxygen from the carrier. 

(8] The World Fact book, Central Intelligence Agency, . http:/ /www.cla.gov/cia/publications/factbook/geos/us.html 

(9) To be conservative, the FAA assumes each POC passenger flies one non-stop round trip per year. 

10 In this analysis the FAA assumes two enplanements per passenger per year to be conservative and not 

overestimate cost savings. In the analysis done for the SFAR the FAA assumed four enplanements per passenger 

per year to be conservative and not underestimate costs. Although there are other differences in the data (for 

instance wage rates have been updated), this accounts for the primary difference between SF AR costs and cost 

savings in this analysis. 

Page 10 
Table 3 Estimated Number of 

Passengers who Fly 

Annually with POCs 

Passengers 

Year w ith POCs 

0 355,411 

1 358,147 

2 360,905 

3 363,684 

4 366,484 

5 369,306 

6 372,150 

7 375,016 

8 377,903 

9 380,813 

10 383,745 

The FAA estimates that it takes a physician 5 minutes to fi ll out the statement (that the passenger 

must have to use the POC on the airplane). While we estimate there are I ,000,000 users of 

medical oxygen, some are homebound and therefore never expect to fly. We assume that 20% of 

these medical oxygen users are homebound, leaving 800,000 who are not homebound. 11 The 

FAA assumes that when a patient who is not homebound is prescribed a POC, the physician as a 

matter of course completes the statement that the POC user can bring on board an aircraft should 

they decide to fly and that they can use for all future flights. The FAA assumes no loss of POC 

user time in receiving the physician's statement. The burdened hourly rate for the physician is 

$105.30 and the cost tor 5 minutes of the physician's time is $8.78. We assume that the 

population of POC users who are not homebound grows by .77% 12 

per year. Without this rule 

we estimate the physicians' costs to issue a statement for nev.r POC users equals the cost of a 

physician's statement multiplied by POC users who are not homebound growing at an annual 

11 National Home Oxygen Patients Association. 

12

Thc population growth rate in the U.S. estimated by the CIA in 20 14, The World Factbook, Central Intelligence 

Agency, https://www.cia.gov/library/publications/the-world-factbook/rankorder/2002rank.html. 

Page 11 
rate of .77% annual growth of POC users who are not homebound. The results are presented in 

the table below (Table 4). 

Table 4 Cost Savings of No Longer Requiring a Physician's Statement 

People with New Physician's 7% present 3% present 

Year POCs [1) Statements [2) Cost savings va lue savings value savings 

0 800,000 

1 806,160 6,160 $54,054 $50,519 $52,481 

2 812,367 6,207 $54,470 $47,574 $51,344 

3 818,623 6,255 $54,890 $44,806 $50,230 

4 824,926 6,303 $55,312 $42,198 $49,145 

5 831,278 6,352 $55,738 $39,741 $48,080 

6 837,679 6,401 $56,167 $37,424 $47,040 

7 844,129 6,450 $56,600 $35,245 $46,021 

8 850,629 6,500 $57,036 $33,195 $45,024 

9 857,179 6,550 $57,475 $31,261 $44,049 

10 863,779 6,600 $57,917 $29,439 $43,096 

Total $559,660 $391,402 $476,509 

[l)People who are POC users when the rule comes into effect will already have a physician's statement. 

The cost savings will result from new POC users who would not have to get a statement. 

[2) Estimated new users who would have to obtain physician's statements without the rule. 

The FAA estimates that when a passenger begins to board ·with a POC, it would take a flight 

attendant about five minutes to notify the pilot in command and the pilot in command one minute 

to receive the information for each flight. The burdened hourly rate for a flight attendant is 

$29.05 and the burdened hourly rate for a pilot is $148.46. The cost for five minutes of a flight 

attendant's time is $2.4 1 and the cost for one minute of the pilot's time is $2.52. The total 

estimated cost to notify the pilot in command per cnplanement is $4.93. The cost per 

enplanement is then multiplied by the estimated enplanements to derive estimates of cost savings 

due to not including in the proposal, the pilot notification that is currentl y required by SF AR No. 

I 06. These estimates are presented in the table below (Table 5). 

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Table 5 Cost Savings of No Longer Notifying the Pilot in Command 

Estimated# of 

Passengers Enplanements JO/o present 3% present 

Year with POCs per year [1] Cost savings va lue savings va lue savings 

0 355,411 710,822 

1 358,147 716,295 $3,534,893 $3,303,711 $3,432,028 

2 360,905 721,810 $3,562,112 $3,111,149 $3,357,647 

3 363,684 727,368 $3,589,540 $2,930,142 $3,284,788 

4 366,484 732,969 $3,617,180 $2,759,547 $3,213,864 

5 369,306 738,613 $3,645,032 $2,598,908 $3,144,205 

6 372,150 744,300 $3,673,099 $2,447,386 $3,076,220 

7 375,016 750,031 $3,701,382 $2,304,850 $3,009,594 

8 377,903 755,807 $3,729,882 $2,170,792 $2,944,369 

9 380,813 761,626 $3,758,603 $2,044,304 $2,880,593 

10 383,745 767,491 $3,787,544 $1,925,208 $2,818,311 

Total $36,599,268 $25,595,997 $31,161,620 

(1) Assume each POC passenger makes 1 non-stop round trip flight per year. 

The table below (Table 6) shows the cost savings that could result because the manufacturer 

would no longer have to petition the FAA to update SF AR No. I 06 and because the proposal 

would no longer require passengers to obtain a physician's statement and that the pilot in 

command be apprised of the POC being on board and informed as to the contents of the 

physician's statement. 

Ta ble 6 Tota l Cost Savings from Proposed Rule 

7% present 3% present 

Cost Savings va lue savings va lue savings 

FAA Savings - No SFAR $91,644 $68,871 $32,573 

Manufacturer Savings - No Petition $108,000 $75,853 $92,126 

No Longer Obtaining Physician's statement $559,660 $391,402 $476,509 

No Longer Notifying Pilot in Comma nd $36,599,268 $25,595,997 $31,161,620 

Total Cost Savings $37,358,571 $26,132,123 $31,762,828 

We note that part 121. 125 and 135 operators would update their training manuals to explain new 

procedures for identifying POCs allowed on aircraft (i.e., identification of the POC label). The 

Page 13 
FAA expects that this update would occur in the normal cycle of manual revision and therefore 

would not result in additional cost for the operators. 

IV. Costs 

Proposed Approval Criteria and Requirement to Affix a Label 

To estimate the costs to the manufacturers of affixing a label on the device, the FAA contacted 

manufacturers that manufacture POCs for use on board aircraft and received feedback from six 

I , 

manufacturers on labelling costs. -' Manufacturers confim1ed that they currently permanently 

affix 14 labels that could be modified with new language at a one-time cost ranging from $200 to 

$10,200. These cost estimates from the mc:mufacturers averaged $2,400 15 per 16 manufacturer. 

17 

Based on this feedback received from manufacturers the FAA estimates the labeling cost to 

permanently affix a label to contain the verbiage proposed in this rule for all nine manufacturers 

is about $22,000. 

V. Net Benefits 

The FAA expects positive net benefits to result from this proposal. The costs manufacturers 

would save because they would not have to go through the SF AR No. I 06 process ($1 08,000) 

would exceed the added costs the POC manufacturing industry would incur from having to affix 

13 Based on the manufacturers who have sought FAA approval for their POCs the FAA believes that the universe of 

potentially affected manufacturers is nine. 1

'

1 Four of six manufacturers indicated they permanently affix the label, one said it cannot be taken off easily and one 

said it was pad printed to the plastic. 15 Some manufacturers indicated the cost might be more if they had to scrap existing inventory of labels, but we 

would not consider this a cost of the rule because these existing labels are not used to demonstrate compliance with 

the SFAR. Also, with adequate notice that the proposal would require a label with specific verbiage manufacturers 

should be able to adjust their label orders accordingly. 16 We assume that manufacturers change the verbiage on one label that they can affix to all new devices and 

therefore these are costs incurred per manufacturer not per device. 17 Manufacturers cited per label costs ranging from 20 cents to one dollar. 

Page 14 
a label indicating the device is safe for use on aircraft ($22,000). 18 There are total cost savings 

of$37.4 million ($26.1 million at 7% present value and $31.8 million at 3% present value). The 

total net savings are $37.3 million. 

Page 15