U.S. Department of Transportation

FEDERAL AVIATION

ADMINISTRATION

FINAL REGULATORY EVALUATION

Acceptance Criteria for Portable Oxygen Concentrators Used On Board Aircraft

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

Carole Gaelick

OFFICE OF AVIATION PO LICY AND PLANS

ECONOMIC ANALYSIS DIVISION1

Table of Contents

List of Abbreviations and Definitions

................................ ................................ .............................. 2 Executive Summary

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

................................ ................................ ................................ ....................... 4
II. Differences Between the NPRM and the Final Rule

................................ ........................ 5
II I. Discussion of the Final Rule

................................ ................................ ................................ ...... 6 IV. Benefits

................................ ................................ ................................ ................................ ... 8 Quantified Benefits

................................ ................................ ................................ ................. 8
Non

- Quantified Benefits

................................ ................................ ................................ ....... 17
V. Costs

................................ ................................ ................................ ................................ 18
V. Net Benefits

................................ ................................ ................................ .................... 182

L ist of Abbreviations and Definitions

FAA

– Federal Aviation Administration

FDA

– Food and Drug Administration

PHMSA

– Pipeline and Hazardous Materials Safety Administration

PIC

– Pilot in Command

POC

- Portable Oxygen Concentrator

RF

– Radio Frequency

SFAR

– Special Federal Aviation Regulation3

Executive Summary

This final rule replace s the portable oxygen concentrator (POC) approval process in Special
Federal Aviation Regulation ( SFAR ) No. 106 with a process by which manufacturers identify
those devices that satisfy FAA acc eptance criteria for POCs intended for use on aircraft. Under
the final rule, a manufacturer may affix a label indicating the device c onforms to FAA
requirements for POC s use d on board aircraft

. By far the largest savings will accrue to the
aircraft oper ators as the pilot

- in

- command will no longer have to be apprised when a passenger
brings a POC onboard the aircraft or be informed about the contents of a POC user’s physician’s

statement . Further, the user will no longer be required to allow the crew to review the
physician’s statement

. The removal of these SFAR N o. 106 requirements is expected to result in
cost savings to the airlines of close to $3 9 million over 10 year s

. Total cost savings are presented

in the table below.

Total Cost Savings from Fina l Rule

Cost Savings 7% present value savings 3% present value savings FAA Savings

- No SFAR $91,644 $68,871 $80,519 Manufacturer Savings

- No Petition $108,000 $75,853 $92,126 Removal of requirement for user to obtain a physician's statement fo r POC use on aircraft $569,961 $401,645 $486,914 Crew review of physician's statement and PIC notification $38,726,085 $27,083,677 $32,972,652 Total Cost Savings $39,495,690 $27,630,045 $33,632,2124

I. Introduction

This final rule replace s Special Federal Aviation Regulation ( SFAR ) No. 106 that prescribes the
existing Federal Aviation Administration (FAA) requirements for aircraft passenger use of
portable oxygen concentrators (POC) during a flight in part 121, 125 and 135 operations

. Under

SFAR No. 106, the FAA assesses each POC on a case

- by

- case basis to determine whether it is

safe for use on board aircraft. In conducting the assessment, the FAA reviews a PHMSA letter
indicating that the POC does not contain hazardous materials, a Food and Drug Adminis tration
(FDA) letter indicating that the POC may be marketed in the U.S. and POC manufacturer
supplied RF interference data

. If the FAA determines that a POC is safe for use on board aircraft,
the specific POC model is added to SFAR No. 106 through rulemak ing and may be used on

board aircraft . The rulemaking process introduces delays for manufacturers who may have to
wait for FAA approval sometimes as long as up to two year s , before the device can be marketed

as safe for use on aircraft

. Furthermore, manu facturers incur administrative costs in complying

with the SFAR while interacting with the FAA during this approval process.

This rule eliminat es SFAR No. 106 and re quir es POCs intended for use on board aircraft to
satisfy FAA acceptance criteria. The manufacturer will no longer have to interact with the FAA

in order for the POC to be allowed for use on aircraft , but will in essence self

- certify

conformance to the acceptance criteria

. This rule will require POC manufacturers to affix a label

to the POC to identify those POCs that co nform to the FAA acceptance criteria and to indicate

that the device is acceptable for use on board aircraft . The label will provide a recognizable
means for crewmembers and passengers to identify POCs that satisfy the accep tance criteria.
The final rule requires a label to be permanently affixed to all POCs that the manufacturer
determines meets the acceptance criteria that were not previously identified in the Special5

Federal Aviation Regulation (SFAR). Only POCs identifie d in SFAR No. 106 as appr oved for

use on board aircraft will not require a label.

In addition, this rule will eliminate requirements in SFAR No. 106 that are currently addressed
elsewhere in the Code of Federal Regulations and remove requirements that are not necessary for
aviation safety.

Overall
, the final rule is expected to relieve regulatory burdens primarily for aircraft operators

and affected passengers

. T he time needed for a POC user’s physician to complete a statement

and the time needed fo r the flight crew to review the contents of the physician’s statement and

the pilot in command ( PIC ) to be notified that the passenger intends to use the POC onboard and
about the contents of the physician’s statement are not time intensive

. However, thes e actions

result in substantial time costs because of their frequency of occurrence

. These cost s avings are

discussed in detail below.

II. Differences Between the NPRM and the Final Rule

There is one key difference between the NPRM and the final rule.

T h is key difference involves POC radio frequency (RF) emissions. The NPRM proposed that

POCs meet the standards of RTCA DO

- 160, Environmental Conditions and Test Procedures for
Airborne Equipment, Section 21, Category M. After further review of the propos al , t he FAA has
determined that the requirement for POCs to be tested in accordance with RTCA DO

- 160 is
overly prescriptive. Accordingly, the final rule include s a performance

- based RF emissions
acceptance criterion that allows POC manufacturers to determ ine how to assess whether their6

POC meets the radiated RF emissions limits for equipment on aircraft, to allow the manufacturer
more flexibility than was proposed in the NPRM.

In addition, other differences between the NPRM and the final rule include :

 Re tain SFAR No. 106 prohibition on exit row seating for passengers using a POC.

 Retain SFAR No. 106 requirements pertaining to stowage of POC.

 Modify required label text so that it uses the POC acronym in place of the full name of

the device.

III. Discussi on of the Final Rule

The final rule allows a passenger to carry and operate a POC for personal use
, and a n aircraft

operator to allow a passenger to carry and operate a POC on board an aircraft operated under

part s 121, 125 and 135 during all phases of fl ight if the POC 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;

(2) Does not radiate radio frequency emission s that interfere with aircraft systems ;
(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 for

ba tteries used to power PEDs when aircraft operator approval is not required ; 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 certification7 statement in red lettering: “The manufacturer of this POC has determined this device
conforms to all applicable FAA acceptance criteria for POC carriage and use on
board aircraft.” The label requirements in this paragraph do not apply to the portable

oxy gen concentrators approved by the FAA for use under SFAR No. 106

.

In accordance with this rule
, a manufacturer will no longer have to seek approval from the FAA

for its device to be allowed for use on aircraft. Instead
, i f a manufacturer determines that a new

POC model conforms to the FAA acceptance criteria the manufacturer can affix the required

label to the device. The label w ill indicat e that the POC meets FAA requirements for use on

board aircraft , as prescribed in this final rule

. The FAA believes the label w ill facilitate
passenger and crew recognition that the POC is safe for use in the cabin during all phases of
flight.

As discussed below, the requirement for a label w ill result in low to minimal costs

. T he removal

of the SFAR No. 106 require ment s for FAA approval of each POC mode l and the subsequent

addition of the POC model to SFAR No. 106 w ill reduce the delay in bringing the device to

market as well as the administrative costs associated with demonstrating to the FAA that the

device meets the criteria specified in SFAR No. 106

. Manufacturers currently bear these cost and
delay burdens.

The FAA acceptance criteria are similar to the approval requirements found in SFAR No. 106
with some exceptions. One exception is the new label requirement

. 1 B ased on information
provided by POC manufacturers
, the FAA expects these costs to be small as manufacturers
already affix a label that can be modified

. The second exception is the final rule requirement for

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

.8

the POC manufacturer to determine that the POC does not radiate radio frequency emissions that

interfere with aircraft systems

. Manufacturers must determine conformance to th is acceptance
criterion before affixing a label indicating that the device may be used on aircraft. This is a
change from t he SFAR No. 106 general requirement for operators to ensure that the device does
not cause interference with aircraft equipment

. Although the SFAR places this burden on the

operator, all POC m anufacturers complete d testing in accordance with RTCA DO 160, Section
21, Category M
, a standard identified for POCs in AC 120

- 95 paragraph 15.a. to support aircraft

operators

. 2 O perators have been able to use the DO

- 160 test data in support of the non

interference determination required by SFAR No. 106 section 3, paragraph (a)(1) , although this
is only one way of demonstrating compliance with the SFAR requirement for non

- interference

. Consistent with current practice, t he final rule places the requirement on the manufacturer (not
the operator as the SFAR does) to ensure the device falls within the radio frequency limits for
equipment intended for use onboard aircraft.



### IV. Benefits

The rule w ill result in relief to manufacturers, POC using passengers , air craft operators and the

FAA

. It will provide relief to manufacturers and the FAA by eliminating the approval process

under SFAR No. 106 , to POC using passengers , by eliminating the requirement to obtain a physician’s statement
, and to aircraft operators by eliminating crew review of the physician’s

statement a nd PIC notification

. The quantification of benefits follows the same methodology as
in the proposed rule as we received no negative comments on this methodology.

Quantified Benefits

2 http://www.faa.gov/about/initiatives/cabin_safety/portable_oxygen/9

In the tables that follow, year 0 represents 201 6 , the year the FAA is i ssuing this final rule

. There may be slight discrepancies due to rounding errors in some tables.

Under this final rule , manufacturers should be able to more quickly market for use on board

aircraft, a new POC model that meets FAA requirements for passenge r use on board aircraft.

The manufacturer will no longer have to submit documents to the FAA verifying the device
meets SFAR No.106 requirements and will no longer have to wait for the FAA, to verify that the
POC meets the requirements and to amend SFAR N o.106, a rulemaking process that might take

up to two years . One manufacturer estimates cost savings of $4,500 3 f r o m each petition for
rulemaking they will no longer have to submit

.

When the FAA added SFAR No. 106 to title 14 of the CFR in 2005, it in cluded two approved

POC models

. 4 There have been seven amendments to SFAR No. 106 in ten years. The current

SFAR No. 106 lists 24 separate POC models that are approved for use onboard aircraft.
Assuming 24 new POCs are introduced over the next ten years, the rule could save the POC
manufacturing industry $108,000. 5

Although this final rule affects only those POCs that will be used on aircraft
, t he FAA received

feedback from a manufacturer that lost revenue can be in the millions of dollars depending on the
length of the delayed product launch. Therefore, another benefit of this rule w ill be to eliminate
these delays and enable manufacturers to bring their devices to the passenger air travel market

sooner.

3 N ot including the cost of the FDA approval or clearance to legally market the device , RTCA testing, and PHMSA determination letter

. This estimate comes from one of the manufacturers. Others referred to reduced delays in introducing product to market and los t revenues. 4 70 FR 40156, July 12, 2005.
5 $4,500 x 24 = $108,00010

Similarly, the FAA will no longer expend resou rces review ing packages from manufacturers and
to update SFAR No. 106

. The FAA estimates that it incurs costs of $ 3,819 per POC model
review and approval and SFAR update process. Assuming 24 new POCs will be introduced over
the next ten years, the final rule could save the FAA $ 91,644

.

The final rule w ill result in additional cost savings because affected passengers w ill no longer
have to obtain a physician’s written statement as a prerequisite to bringing POCs on board
aircraft in part 121, 125, and 13 5 operations.

Most of the cost

- savings associated with the final rule will result because the PIC w ill 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 wri tten statement.

To estimate the burden relief, the FAA first explains how we 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 fi rst due to the elimination of the physician’s

statement and then due to elimination of requirement for the crew to review the statement and to
notify the PIC that a passenger intents to use the device and on the contents of the physician’s

statement

.

At th e time of the NPRM, t he National Home Oxygen Patients Association indicate d on its
website more than one million supplementary oxygen users in the United States and the
University of California San Francisco Medical Center estimated 1.5 million supplementa l
oxygen users in the U.S. 6 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

6 www.ucsfhealth.org/education/supplemental_oxygen/more_resources/11

to Travel study 7 released by the Bureau of Transportation statistics indicat ed 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. 8 Assuming the percent of the U.S. population that is
disabled remains constant, we estimate approxima tely 57 million disabled people in the U.S. in

201 4

. 9 According to the Annual Report for 201 4 on Disability Related Air Travel Complaints
there were approximately 2 1 million people with disabilities who travelled by air in 201 4

. 10

Dividing 2 1 million by 5 7 million the FAA estimates that about 3 7 % of persons with disabilities
travel by air. If we assume that those supplemental oxygen users travel on commercial airlines at

the same rate as all persons with disabilities , we estimate that 3 7 0,000 people needi ng
therapeutic supplemental oxygen travelled by air in 201 4 . Assuming that the population of
people who fly with POCs increases at the rate of the U.S. population, 11 the FAA estimated the
population of passengers traveling with POCs will be 376,093 in 201 6 . Table 3 projects the

number of passengers traveling with POCs if that population increases at the same rate as the
U.S. population growth rate. 12

The burdened wage rates in 2012 dollars for the affected professionals are presented in T able 1

below.

7 Freedom to Travel, Bureau of Transportation Statistics, U.S. DOT, 2003
8 The U.S. population was just over 290 million i n July 2003
, http://www.census.gov/popest/data/intercensal/national/nat2010.html

9 The U.S. population was almost 31 9 million in July 201 4 http://factfinder.census.gov/faces/tableservices/jsf/pages/productview.xhtml?src=CF
10 Annual Report for 201 4 on Dis ability

- Related Air Travel Complaints , which refers to estimates of number of disabled who travelled by air in 2001/2002 from data obtained from the National Household Travel Survey and using enplanements in the intervening years to project that one can as sume that over 2 1 million persons with disabilities travelled by air in 2014

. 11 According to the Census Bureau, the U.S. population increased at the rate of .82% in the years 2015 and 2016

. 12 The Census Bureau estimated annual growth rates ranging from .72 % to .81% over the time period covered.12 Ta ble 1 Wage Rates Used in the 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 $21.57 $148.46
Physician (5) $90.00 $15.30 $105.30

Wage Multiplier Wag e Multiplier (6)(7) 1.17 (1) http://www.bls.gov/ooh/transportation

- and

- material

- moving/flight

- attendants.htm#tab

- 1 (2) Estimate flight attendants work 1500 hours per year, based on attendants typically flying 75 hours a month and spending 50 hours a month on the ground, Source: http://www.bls.gov/ooh/transportation

- and

- material

- moving/flight

- attendants.htm#tab

- 3 (3) http://www.bls.gov/ooh/transportation

- and

- material

- moving/airline

- and

- commercial

pilots.htm (4) Based on pilot flying an average 900 ho urs per year, Source: http://www.bls.gov/ooh/transportation

- and

- material

- moving/airline

- and

- commercial

pilots.htm#tab

- 3 (5) http://www.bls.gov/ooh/healthcare/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.13

Table 2 presents the assumptions 13 and estimates used in the subsequent analysis.

Table 2 Assumptions and Estimates Used in the Analysis Number of supplemental 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] 290,107,933 Disabled as Percent of U.S. Popula tion in 2003 (rounded to nearest %) 18% U.S. population July 1, 2014 [4] 318,857,056 Number of people with disabilities who travelled by air in 2014 [5] 21,000,000 Estimated Number of people with disabilities in the U.S. in 2014 [6] 57,394,270 Estimate d % of disabled who travel by air in 2014 (rounded to nearest %) 37% Estimated passengers with POCs in 2014 [7][8] 370,000 Population growth rate in U.S. [9] 0.82% Estimated number of passengers with POCs in 2016 376,093 Number of enplanements per pas senger per year [10] 2 (1) National Home Oxygen Patients Association
[2] "Freedom to Travel, pg. 2, U.S. Department of Transportation, Bureau of Transportation Statistics, 2003. [3] http://www.census.gov/popest/data/intercensal/national/nat2010.html [4]http://www.census.gov/popest/data/national/totals/2014/index.html [5] Source Annual Report for 2014 on Disability

- Related Air Travel Complaints, pg. 4, Report of the Secretary of Transportation to the U.S. Congress, February 2014 [6] Assumes pe ople with disabilities is the same percent of U.S. Population in 2012 as in 2003 [7] Assumes users of supplemental oxygen fly at the same rate as the disabled population. [8] The FAA assumes that all supplementa l oxygen users who fly will carry a POC. This may overestimate the # of passengers with POC because some may rent oxygen from the carrier.

[9] http://www.census.gov/population/projections/data/national/2014/summarytables.html, 2015 and 2016.

[10] To be conservative, the FAA assumes each POC passenger flies one non

- stop round trip per year.

13 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 pe r 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 SFAR costs and cost savings in this analysis.14 Table 3 Estimated Number of Passengers Who Fly Annually with POCs

Year Population Growth Rate Passengers with

POCs 0 376,093 1 0.81% 379,139 2 0.81% 382,210 3 0.80% 385,268 4 0.79% 388,312 5 0 .78% 391,340 6 0.77% 394,354 7 0.76% 397,351 8 0.74% 400,291 9 0.73% 403,213 10 0.72% 406,116

The FAA estimates that it takes a physician 5 minutes to fill out a statement ( that the POC user is
required to obtain in order to use the POC on the airp lane )

. While we use the estimate of

1,000,000 users of supplemental oxygen , some are homebound and therefore do not expect to
fly. We assume that 20% of these supplemental oxygen users are homebound, leaving 800,000

who may use a POC on board an aircraft

. 14 For purposes of this analysis t he FAA assumes that
when a patient who is not homebound is prescribed a POC, they ask the physician to provide the
physician statement required by the SFAR so they have the option of flying with the POC. We

assume that ea ch POC patient obtains only one physician’s statement . 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 for 5 minutes of the physician’s time is $8.78. We assume that

14 National Home Oxygen Patients Association

.15

the population of POC users grows by the same rate as the U.S. population 15 each year. Without

this rule we estimate the physicians’ costs to issue a statement for new POC users equals t he cost

of a physician’s statement multiplied by new POC users who are not homebound

. The results are
presented in Table 4

.

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

Year Population Growth Rate People with

POCs [1] New

Physician's Statements [2] Cost

savings 7% present

value savings 3 %

present value savings 0 813,174 1 0.81% 819,760 6,587 $57,831 $54,049 $56,148
2 0.81% 826,401 6,640 $58,300 $50,919 $54,953
3 0.80% 833,012 6,611 $58,046 $47,383 $53,118
4 0.79% 839,593 6,581 $57,779 $44,080 $51,337
5 0.78% 846,141 6,549 $57,4 99 $40,997 $49,598
6 0.77% 852,657 6,515 $57,204 $38,115 $47,909
7 0.76% 859,137 6,480 $56,896 $35,429 $46,262
8 0.74% 865,494 6,358 $55,820 $32,487 $44,064
9 0.73% 871,813 6,318 $55,473 $30,172 $42,515
10 0.72% 878,090 6,277 $55,113 $28,014 $41,009
Total $569,961 $401,645 $486,914

[1]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 u sers who would have to obtain physician's statements without the rule.

The FAA estimate s that when a passenger begins to board with a POC, it take s a flight attendant

about four minutes to review the contents of the physician’s statement . The flig ht attendant then
notifies the pilot of passenger intent to use the POC onboard and of the contents of the
physician’s statement. The FAA esti ma tes this takes one minute each of pilot time and flight

attendant time. The total estimated cost of the review and the PIC notification per enplanement is

15 http://www.census.gov/population/projections/data/national/2014/summarytables.html16

approximately $4. 90 . The cost per enplanement is then multiplied by the estimated
enplanements to derive estimates of cost savi ngs due to no longer requiring , the pilot notification
that is currently required by SFAR No. 106. These estimates are presented in Table 5

.

Table 5 Crew Review of Physician's Statement and PIC Notification

Year Passengers with POCs Estimated # of

Enplanements per year [1] Cost savings 7% present value savings 3% present

value saving s 0 376,093 752,186 1 379,139 758,278 $3,738,313 $3,493,827 $3,629,528
2 382,210 764,421 $3,768,593 $3,291,489 $3,552,276
3 385,268 770,536 $3,798,742 $3,100,913 $3,476,229
4 388,312 776,623 $3,828,752 $2,920,955 $3,401,846
5 391,340 782,681 $3,85 8,616 $2,751,193 $3,328,442
6 394,354 788,707 $3,888,328 $2,590,793 $3,256,474
7 397,351 794,702 $3,917,879 $2,439,663 $3,185,627
8 400,291 800,582 $3,946,871 $2,297,079 $3,115,660
9 403,213 806,427 $3,975,683 $2,162,374 $3,046,964
10 406,116 812,233 $4,004,308 $2,035,390 $2,979,606 Total $38,726,085 $27,083,677 $32,972,652 (1) Assume each POC passenger makes 1 non

- stop round trip flight per year.

Table 6 shows the total quantified cost savings that could result because the manufacturer will n o
longer have to petition the FAA to update SFAR No. 106
, because the rule w ill no longer require

passengers to obtain a physician’s statement and because the re will no longer have to be crew
review of the physician’s statement and PIC notification of the POC being onboard and of the
contents of the physician’s statement

.17 Table 6 Total Cost Savings from Final Rule

Cost Savings 7% present value savings 3% present value savings FAA Savings

- No SFAR $91,644 $68,871 $80,519 Manufacturer Savings

- No Petition $108,000 $75,853 $92,126 Removal of requirement for user to obtain a physician's statement for POC use on aircraft $569,961 $401,645 $486,914 Crew review of physician's statement and PIC notification $38,726,085 $27,083,677 $32,972,652

Tot al Cost Savings $39,495,690 $27,630,045 $33,632,212
We note that p art 121, 125 and 135 operators w ill update their training manuals to explain new
procedures for identifying POCs allowed on aircraft (i.e., identification of the POC label). The
FAA expect s this update w ill occur in the normal cycle of manual revision and therefore w ill not
result in additional cost for the operators.

Non

- Quantified Benefits
Performance

- Based RF Emissions Acceptance Criterion

For POC RF emissions evaluation, the FAA current ly accepts as proof of non

- interference,

radiated RF emissions tests results showing that the device does not exceed thresholds
established in Section 21 Category M of RTCA DO

- 160. Currently the manufacturers provide
these RTCA test compliance results to t he FAA which posts these results on its website for
aircraft operators to access. This final rule will include performance

- based RF emissions
acceptance criterion that allows POC manufacturers to determine how to assess whether their

POC meets the RF emis sions limits for use on aircraft before they affix a label to the device
confirming that this criterion has been satisfied. This might save manufacturers some cost if they
can demonstrate in a less expensive way that their device meets the RF emissions cri teria and18

will not degrade safety as the alternative method is an equivalent level of safety to the RTCA

standard.

V. Costs

Approval Criteria and Requirement to Affix a Label

The FAA use d the same methodology to estimate costs as used in the NPRM, because it received

no comments on th at methodology. To estimate the costs to the manufacturers of affixing a label

on the device, t he FAA contacted manufacturers that manufacture POCs for use on board aircraft

and received feedback from six manufacturers on labelin g costs

. 16 Manufacturers confirmed that
they currently permanently affix 17 labels that could be modified with new language at a one

- time
cost ranging from $200 to $10,200. These cost estimates from the manufacturers averaged
$2,400 18 per 19 manufacturer

.

Based on this feedback received from manufacturers the FAA estimates the labeling cost to
permanently affix a label to contain the verbiage required by this rule for all nine manufacturers
is about $22,000

.

V. Ne t Benefits
The FAA expects positive net benefits to result from this rule

. T he costs that POC
manufacturers will save because they will not have to pursue the SFAR No. 106 process

16 Based on the manufacturers who have sought FAA approval for their POCs the FAA believes that the universe of potentially affected manu facturers is nine.
17 Four of six manufacturers indicated they permanently affix the label, one said it can no t be taken off easily and one said it was pad printed to the plastic.
18 Some manufacturers indicated the cost might be more if they had to scrap ex isting i nventory of labels, but we do 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 rule will require a label with specific verbiage manufacture rs should be able to adjust their label orders accordingly

. 19 We assume that man ufacturers 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

. Manufacturers cited per label costs ranging from 20 cents to one dollar , when fixed costs were distributed over labels expected to be produced

.19

($108,000)
, will exceed the added costs from having to affix a label indicating the device is safe

for use on air craft ($ 22,000 )

. The re are total cost savings of $ 39.5 million ($ 27.6 milli on at 7%
present value and $ 33.6 million at 3% present value)

.