U. S. Department or · rra ns portation

FEDERAL AVIATION ADMI N IS TRATIO N


## 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 Abbrev iations and Defin it ions .............. . ............... ... . . ... . ... .. . . ......................................... .. . . . .. 2 Execu ti ve Su n11nary .. ... . .................. . .... . . . . . ................... ... . .. .. .. ..................... . . . ........................ . .. . .. . .. . 3 I. Introduction ... . . . . . . . . .. ........................... .. .............. . ... . ....... .. ......................... . . . ......... . ........... 3 II. Discussion of the Proposed R ule . . ................................................................ . ................... 5 Ill . 

### Benefits . . ... ..... .............. . .... . ... . .... . ....................... . ... .. .. .. . . . . ... . ... . .................... . ...... . ............. 7 IV. 

### Costs ............ ... ... .... ... . ... .. ................... . ... . .... . . . . . . . . .. .. .. ... . .................... .. ............................. l4 V. 

### Net Benefits ............. . ... . .... . ... . .... . .................................... . ... . . . . . . . . . ... . .. . . . . . .. . ... .. .. .. . . . .... . . ... l 4



### Page 1

### List of Abbreviations and Definition s FAA- Federal Aviation Administration FDA
- Food and Dru g Admi ni strat ion PH MSA- Pip e lin e a nd Haza rdous Materia ls Safety A dministration POC
- Portable Ox yge n Co n cent rat or RTCA
- Radio Technical Comm ission for Aeronautics SFA R
- Special Fed e ral Aviation Regulation

Page 2

## Executi ve Summary The FAA is proposing a rule to replace current Special Federal Aviation Regulation (SFAR) No. 106. The FAA is proposing to eliminate the current process by which portable oxygen concentrator (POC) manufactur e rs have their devices approved by the FAA for use on aircraft and replace it with a proc e ss 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,r ould 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 SFAR 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 Cos t Savings FAA Savings- No SFAR Manufacturer Savings- No Petition No Longer Obtaining Physician's sta t ement No Longer Notifying Pilot in Command Total Cost Savings


### I. 

## Intr odu ction $ 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 (SFAR) 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 Page 3

### ope rati on s , co mm er c ia l ope rat ions and ce r tain other operati ons usi ng large aircraft. Today the F

AA assesses eac h POC on a case - by
- case basis to detem1ine whether i t is safe fo r use on board aircraft. If the F AA de t ermi nes that a P OC is safe for use o n boar d ai r craft. th e spec i fic P OC m od e l is id e ntifi e d in th e Co de o f F e d e ra l R eg ul at io ns throu gh rul e m a kin g. T he rul e ma kin g process introd uces de lays for manu fac turers who may have to wait f o r FAA app rova l somet im es as long as up to two years , before t he device can be marketed. Manufac tu r ers incur admin i strative cos ts in comp l ying with the S F AR and i nteractin g with the F AA du r ing the process. Thi s r ul e proposes e limin atin g S F A R No. I 06 an d r equ i rin g P OCs int en d ed f o r use o n board a ir craft to sati sfy FAA acce pt an ce cri t e r

ia. T he ma nu fac turer wo ul d no t have to int e r ac t with th e FAA i n order for the P OC to be cert i fied , bu t wo u ld in essence b e self-certi fy ing. T his proposa l would r equire P OC ma nufactu r ers to affix a labe l to the POC to cert i fy co mplia nce w ith the acce pt ance c riteria. Th e labe l wo ul d provide a recog ni zab le m ea n s for cr ewmemb er s and passe n ge rs to id e ntif y POCs th a t s ati sfy th e acce pt a nce c riteri a . PO Cs c urrentl y a ppr oved f o r u se o n boa r

d a i rcraft by th e FAA wo ul d continue to be i dent i fied i n the Code of F ede ra l R

egu lations as approved f or use o n boar d ai r craft and wo u ld not r equi r e a labe l.
In ad d i tio n , thi s p roposa l wo ul d e limin ate r eq u ire m ent s in SF AR No. I 06 th at ar e c urr en tl y addresse d e l sewh er e in th e Co de o f Fede ra l R egu lati ons and re m ove requiremen ts that ar e no t necessary for av iat ion safety. By do ing so, it wou ld r elieve regu latory burdens for , airli nes, passe n gers a nd p h ys ic ians. Eve n th o ug h the t ime-to-comple t e the ph ysician's state m ent and in fo rm in g t he pi l o t- in-com mand abou t a passe nger boar d in g wi th a POC are no t tim e int e n s i ve, th ese ac t io ns r es ul t in s ubs t a nti a l c o s t s becau se o f th e i r f r equ ency of occu rrence r es ultin g in s u bsta n ti al costs. These cos t sav i ngs are discussed in de ta il be l ow.



### P

age 4

### H. Discussion of t he Proposed Rule

T he rule propo ses th a t a passe nger may carry and o pe rate a POC for personal us e a nd a cert ificat e holder may a ll ow a passe nge r to carry and ope ra te a PO C on board an a ircraft opera ted und e r thi s part durin g all phase s of flig ht if th e POC sat i s fie s a ll of th e fo ll owing r e quire ment s: (I ) 

### Is lega ll y m ark ete d in the Unit ed States in accordance w ith Fo od and Drug Ad mini s tration requ ir e ment s in titl e 2 1 ; (2) 

### Me et s th e s t an dard s of RT CA D0-160G , Environ m e nt al Conditions and Test Proc e dures f o r Airborne Equipment , Se ction 21, Category M i ss ue d Dece mber 8 , 20 10; ( 3 ) 

### Generate s a maxi mum oxyge n pre ss ure of l ess tha n 200 k Pa ga uge (29.0 psi g/43.8 psia) at 20 ° C (68 ° F); (4) Do es not conta in a ny ha zardou s ma t eri als s ubj ec t to th e I 

### l aza rdou s Materials Rc !!. ul ation s (49 CFR parts 171- 180) exce pt as provided in 49 C FR 175.1 0 ; and (5) 

### Bears a lab e l o n th e exterio r of th e devic e th at r e ma in s affix ed f o r th e li fe of the device and co ntain s the f ollow in g ce rtifi cat io n state m e nt i n red lett eri ng: " Th e man ufa c tur er o f thi s portabl e oxyge n conce ntr ator has d etermin e d thi s device conform s to a ll applicable FA A r eq uire m e nt s for portab le oxyge n concentrator carriage a nd use o n board airc ra ft.. "

Page 5The label requirements do not apply to the POCs that have a l ready been approved by the FAA for u se onboard aircraft by the date indi cated in the proposed rule text. These devices are listed in th e proposed rule text.

In accordance with this proposal , manufacturers of POC models wh ich are not already identified in SF AR No. I 06 wo uld 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 c rit er ia , 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 spec ifi ed in the proposed regulation. The label would indicat e that the POC meets FAA requirements for use o n board aircraft. The FAA believes the label would facilitate passenger and crew recognition that the POC is safe for us e 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 the ir devices meet the acceptance crit eria in SFA R No. 106 would re duce the delay in bringing the device to market and the administrative costs associated with d e monstrating to the FAA that the d e vice meets the criteria specified in SF AR 106.

The proposed FAA acceptance criteria are simi J ar to the approva l requirements found in SFAR No. 106 with some exceptions . One exception i s the proposed lab el wh ich i s not currently required by SFAR 106. 1 Based on discussions with manufacturers, the FAA expects these costs to be sma ll. The second exception i s the proposal that the device must meet the RTCA standards indicated above in place of the general requirement for operators to ensure that th e device does not cause interference with aircraft equipment. Based on a review ofPOC 

### EMI testing results
1 Under the current regulatory regime , those d ev ice s th at have been approved for use on aircraft by the FAA are listed in the SFAR , and air lin es check the l ist before a ll owing the device on board the aircraft. Page 6provided to the agency. the FAA has determ ined that a ll m anufacturers currently complete test ing in accordance w i th R T CA standard 1 600. Sect ion 21 , Category M. All devices li s t ed in the SF AR have met the se RTCA standards (or a n earl ier but equiva le n t s ta n da rd). 

### III. Benefits The proposed rule would provide relief to ma n u f acture r s , the FAA , pa sse ngers , ai r lines a n d physicians. It wou ld provide re li ef to manufacturers and the FAA by elimina ting th e SFA R process, to p h ys i c i ans a n d passe n ge r s by n o l o n ge r req uirin g a physic i a n ' s s tateme n t, a nd t o airlines by no longer requiring p il ot n otification.

In the tables that follow in this report , yea r 0 represents 2014, the yea r this report is published. T h ere may be s li gh t discrepanc ies due to r o un di n g error in some tab les .
U nder this proposal. manufacturers shou ld be able to more quick ly ma rket a new POC that meets FAA requiremen t s f o r u se on board a i rcraft. Th e ma n ufac turer would n o longer have to s u b m i t documents to the F/\A verify i ng the device meet s SFAR No.I 06 requi reme n ts and wou ld no longe r h ave t o wa it f or th e FAA, to ver i fy th a t th e POC m ee t s th e re quire m en t s a nd to am e nd SF AR No . I 06 , a rulemaking process that might take ove r a year. One manufacturer est imates cost savings of $4,500 2 from each petition fo r ru lemaki n g they wou ld n o longer have to submi t. The re have been 24 P OCs added to SF AR No. I 06 s i nce 2005. Ass u ming 24 n ew POCs are in t rod u ced over the nex t t en years, the proposal cou ld save th e POC man u fac turin g in d u stry $ 1 08 , 000. 3

1 Not including th e co s t of th e FDA appro val to legall y market the device , RTCA te s t ing. and PHMSA determina t ion Jetter. This e s t imate comes from one of the m an ufacturers. Ot hers referred to reduced de l ays in introducing product to market and lo s t revenu es. J $4 , 500 X 24 

### = $) 08 ,000 P age 7

### The f AA rece ive d feedback from th e PO C manu fact urin g industr y indicating that the delays manuf ac tur ers encou nt er whi le waiti ng for th e ir POC dev ic e to be ap p roved d urin g th e S F A R p rocess put th e m at a compe titi ve disad va n tage re lat i ve to othe r manufacture rs whose device s ha ve al ready been ap proved and th e d elay might cost the manufacturer millions of dollars in lost r eve nu es . Therefore , another benefit of thi s rule wou ld be to e l im in ate th ese delays a nd enable manu facturers to bring their devices to market soo ner.
S imilarl y, th e FAA wou ld no l onger hav e to expe nd resource s to review th e p ac ka ges from th e man uf ac tur ers and to up date th e S FAR. The FAA es timate s that it in curs costs of $3 , 819 per POC in th e rev iew an d ap prova l process. Assuming 24 

### new POC s wou ld be introduced ove r the next t e n years , the proposal could save the F AA $9 1 , 644.

T he p ropose d rul e wo uld result in additional cost savings because af f ec ted passengers wo uld no lo nge r have t o obtain a physician ' s writte n s ta t ement , a s a pre req ui s i te to bring in g POCs on board a ircraft in part 12 1 , 1 25, and 135 operations. In addi ti o n , the proposed rul e wo uld res ult in cost sav ing s because th e pilot in command wo uld no lon ge r have to be n o tifi e d w he n an affected passenger int e nd s to use a PO C on the a ircraft and be informed abou t th e co nte nt s of th e physician 's writt e n stateme nt. To est im ate the burden

**li ~**  

### th e FAA first explai n s h ow \Ve der i ved th e numb er of pa sse ngers w ith POC s. T he n we provide th e burdened wage rates for the affected pro f ess i ona ls. W ith that basis , the estimated cost savi ngs is discussed first for ph ysicia n s and the n airline crews . Th e FAA th e n est im at ed th e numb er of POC u se rs expected to take commercia l fli ghts. The Nationa l Home Oxygen Patients Associat ion indi cates on it s websi te that th ere are more th a n one Pag e 

### 8

### million s uppl e me ntar y oxyge n users in the Unit ed Stat es 4 

### and th e Univ ersi ty of Southern Ca lif o rni a Medica l Ce nt er est im ated 1 .5 mi lli o n s uppl e me nt a l oxyge n u se rs in the U.S. 5 

### To be co nse r va ti ve we ass um e that th ere are one million supp l e me ntary oxygen us ers in the U.S , of w hi ch some s ub se t w i ll fl y w ith a POC. Th e Freedom t o Tra ve l s tu d y 6 

### released by the Bur eau ofTrans pm1atio n stat is t ics indicated that peo pl e w i th di sab iliti es repr ese nted ove r 53 m illion peo pl e in th e U.S. Thi s i s abo ut 1 8 % of th e U. S. popu lation th e year th e s tud y was released. 7 

### Assuming th e pe rc e nt of th e U . S . population that is di sab le d remain s constant , we es timat e approximate ly 57.3 milli o n d isabl e d peo pl e in th e U.S. in 2012. Acco rding to th e Annu al Re port for 20 12 o n Di sability Relat e d Ai r Trave l C omp lai nt s th e re we re approximatel y 20 milli o n peop le with disabilities who tra ve ll ed by air in 201 2. 8 

### Divid in g 20 million by 57 mi ll io n th e FAA est imat es that about 35% of perso ns w ith di sab ili tie s travel by air. If we assume th at th ose me dica l oxygen users trave l on commerc ia l airlines at the s ame rate as all persons wi th d isab il iti es, we es timate th at 350 ,0 00 peo pl e n eedi ng s upp le me ntal oxygen travelled by a ir in 20 12 . Ass umin g that the p o pu l ation o f peo pl e w h o fl y wit h POCs i ncrea ses at th e rate of th e U.S . po pulation. 9 

### the FAA es timat e d th e popu lati on of passe ngers trave lin g w ith ro es w ill be 355,4 1 1 in 20 14. The tabl e below proj ec t s rO C pa sse nge rs i f that population in c r eases at th e s ame rate as th e U . S . population g row th rat e (20 14 es timat e). Th e burden e d wage rates in 2012 dollar s fo r the aff ec te d prof ess io nal s a re pre se nte d in the tab le be low (Tab le I ).

4 www.homeoxygen.org 5 www

**.uc O~ea**  lth .o rgle ducation/s up plementa l _ oxyge n/ more

_re so urce s/ c. Freedom to Travel. Bureau of Tran s p ortation Statis t ics , U.S. DOT , 2003 7 The U.S. population was jus t over 290 million in Jul y 2003. 8 Annual Report f or 2012 on Di sabi lity-Relat ed Air Trave l Co mpl a int s, whi ch refe rs to es tim ates of number of disab led who tra velled by air in 200 1 /2002 from data ob tained fr om th e Na t ional Hou se hold Trave l S urvey and us in g e np la ne m e nt s in th e intervening years to proj ec t that o ne ca n ass um e that ove r 20 mi ll ion perso ns with d isa b i lit ies trave ll ed by a ir in 201 2. 9 Acco rding to th e C IA Wo r ld Fact book th e U.S. popu lat ion is increas in g at the rate of . 77 %. 

### Page 9Table 1 Wage Rates Us ed in tbe Analysis Job Category Hour l y wage (8) Ov e rh ea d To t a l Flight Attendant (1)( 2 ) $24
. 83 $4.22 $29 . 05 Pilot in Command (3)(4) $126.89 S21.5i $148.46 Physic i a n ( 5 ) $90.00 $15 . 30 $105 . 30 W age Mu l tipl i er Wage Mul tipl ier (6)(7) 1.17 ( 1} http://www .bls.govI ooh/tra nsp o rta t ion - and · materia I · moving/flight - at t end ants.htm11tab-1 (2} Estimate flight attendants work 1 500 hours per year, based on attendants t ypically flying 90 hours a mon t h and sp ending 50 hours a m o nth o n the g rou nd, source BLS ( 3) http :/ /www
. bls . govI ooh/tra nsportation-and - mater ial -moving/ ai rl ine -and-commerc i al· pi l ots. htm (4) Based on p i lot wo rk ing an a v erage 900 hours per year. (5) ht tp : //www
. bls.gov/ ooh/hea l thca re/ physicians-and-surgeons. htm (6) Memorandum on Estima ti ng Total Costs of compensat i on Based on Wage Rates o r Salaries, U.S
. Department of Transp ortat ion, Janua ry 30 , 2014. (7) Wage multiplier for sala r ied emp l oyees (8) Wag e R ates a re in 2012 dollars



### Tabl e 2 presents th e assumptions 10 

### and estimates used in th e s ubs equ ent analysis.

Tabl e 2 Assump t ions a n d Estim01 t es U s ed in th e**An:~lysis** Number of medica l oxygen users (1) 1,000,000 Number of peop l e wit h d isabilities in u.s. in 2003 [2) 53,000,000 U . S
. p opu l ation Ju l y 1, 2003 [3 ] 290,110 , 000 Disab l ed as Percent of U.S. Population in 2003 (ro unded to nearest%) 18 % u.s. popu l ation July 1, 2012 ( 3] 313,910,000 Number of people wi th disabilities who travelle d by a i r in 20 12 ( 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 t o nea res t%) 35 % Estima t ed passengers wi t h POCs In 2012 ( 6)(7) 350,000 Pop ul ation growth rate in U.S
. (8] 0.77% Estima t ed number of passengers with POCs I n 2014 355,411 Numb e r of enplanements per passenge r per yea r (9) 2 (1] N ation al Home Oxygen Patients As sociatio n (2) " Freedom to Travel, pg . 2, u.s . Departm en t of Transportation, Bureau of Tran sporta t ion Statistics , 2003 (3] U.S. Population by Year , h ttp: / /www.mul tpl. com/un ited-states-populatlon/table (4 ] Sou r ce Annual Report for 2012 on Disabili ty- R e lat ed Air Travel Comp l aints , pg. 4, Report of t h e S ecretary o f Transportation to the U.S. Cong r ess, Feb r uary 2014 ( 5] A ssumes people with disabilities is the same percent of U.S. Population in 2012 as in 2003 {6 ] Assumes users o f medical oxygen f l y at the same rate as t he disabled popu l at •on. (7 ] The FAA assumes that all me d ica l o x ygen users who fly will ca rry a POC
. This may overestimate th e II of passen ge rs wi t h POC because some may rent oxygen f r om the carrier. (8] The World Fact boo k, Cent r al Intelligence Agency , . http:/ /www.cla.gov/cia/pub li ca ti ons/ fa ctbook/geos/us.h tml ( 9) To be conservative, t he FAA assumes each POC passenger fli es o ne non-stop round trip per year.

10 In thi s a nal ys is the FAA ass ume s two e np lane m e nt s per passenger pe r yea r to be conservative and not overestimate cost savings . In th e ana lysis d o ne for th e SFAR th e FAA a ss um ed four e np la n eme nt s pe r pa sse nger per year to be conservative and not und erest im ate costs. Although th ere are oth er di ffere nces in the data (for instance w age rates hav e been updated), thi s accounts for th e p rimar y difference betw ee n S F AR costs and cost sav in gs in thi s analysis. 

### Page 10Tabl e 3 Estimat e d Numbe r of Passeng ers wh o Fly An nu a lly wi t h PO Cs 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 9 380,8 1 3 10 383,745 The FAA estimates that i t takes a physician 5 minutes to fi ll o u t th e statement (that the passe n ger must have to u se the POC on the airplane). While we estimate there are I , 000 , 000 users of medical oxygen , some a re homebound and therefore never expect to fly . We assume that 20% of these medica l oxyg e n us e rs are homebound , leaving 800 , 000 who are not homebound. 11 T h e FAA assumes tha t when a patient who is not homebound is prescribed a POC , the physician as a matter of course comp l etes the statement tha t the POC user can br i ng on board an a irc raft shou ld th ey dec ide to fly and that th ey can use for all future flights. The FAA assumes no loss of POC us e r time in receiving the physician ' s statement. The burdened hour l y rate fo r the physic i an is $105.30 and the cos t tor 5 m inutes of th e physician 's time is $8.78. We assume th at the popula tion of POC us e rs who are not homebound g r ows by . 77% 12 per year. Without th i s rule we est i mate the phys ic i ans' costs to issue a s t a t ement for nev.r POC u sers equals the cost of a p h ysician ' s statement multip l ied by POC users who are not h omebound growing at an annua l

11 Nat ional H o m e Oxygen Pati e nt s Associat io n. 1 2Thc population growth rate in the U . S. estimated by the C I A in 20 1 4, The World Factbook , Centra l Intell igence Agency , https: // www.cia.gov/ l ibrary / pub l ications/the-world-fac tbook/rankorder / 2002rank.html . 

### Page 11

### rate of . 77 % annual g rowth of PO C users who are no t ho m ebound. The r esul t s a r e presented in the table below (Table 4). Tabl e 4 Cost Savings of No Longer Requ irin g a Ph y s i cian's Statement Peop l e w ith New P h ysician's 7 % prese nt 3% present Year POCs [1) Sta tements [2) Cost sav in gs va l ue sav ings value sav i ngs 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 $57,9 17 $29,439 $43,096 Tota l $559,660 $391,402 $476,509 [l ) People wh o are PO C users when the rule comes into effect wi ll already have a physician ' s statement . The cost savings wi ll re sul t from new POC use r s who would not ha v e t o get a sta tement. [2 ) Estima ted new users who would have to obtain physician' s sta tem ents withou t the rule .


### The F AA estimates th at when a passenger begi n s t o board ·wi th a POC , it would take a fli ght att e ndant about fi ve minut es to noti fy the pil o t in co mmand and the pilot in comma nd one minut e to r e c e iv e th e inform ation for eac h flight. T h e burdened ho url y rate for a fli g ht attendant i s $29.05 and the burdened ho url y ra te for a pil ot is $ 148.46. Th e cost for fi ve minut es of a fli g ht attenda n t's time is $2.4 1 a nd the cost for one min ut e of the pilot ' s tim e is $2.52. The total es timat ed cost to no tif y the pil ot in command per c npl aneme nt i s $4 . 93. Th e cost per e np lanement is th e n multipli e d by the estimated e nplan e ments to d eriv e es timates of cost savings due to no t includin g in th e proposal , the pilot not ifi ca ti o n th at is cu rren tl y r e quired by SFA R No. I 06. Th ese es tim ates are prese nte d in th e tabl e below (Tab le 5).

P

age 12Table 5 Cost Savings of No Longer Not i fying the P ilot in Command Estimated# of Passengers Enplanements JO/o present 3% present Year w ith POCs per yea r [1 ] Cost sav in gs va l ue savi ngs va l ue savings 0 355,411 710,822 1 358,147 716,295 $3,534,893 $3,303,711 $3,432, 0 28 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 ,54 7 $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, 1 70,792 $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 To t al $36,599,268 $25,595,997 $31,161,620 (1) Assume each POC passe nger makes 1 non-stop round t r ip flight per year. T h e table below ( T ab le 6) s ho ws the cost sav in gs that could result b eca u se th e manufacturer would no longer hav e to petition the 

### FAA to update 

### SF AR No. 

### I 06 and b eca u se th e proposal would no longer require passengers to ob t ain a p h ysician's s t a t e m ent and that th e p il ot in co mma n d be apprised of th e POC bein g o nboard and informed as to th e con t e n t s of the physician 's statement. T

a bl e 6 T o t a l Cost Savin gs from Pro posed Rule 7 % pr ese nt 3% p rese nt Cost Savi n gs va lu e sav ings va l ue sav ings FAA Savings
- No SFAR $91,644 $68,871 $32,573 Manufacturer Sav ings - No Petition $108,000 $75,853 $92,126 No Longer Obtaining Physician's statement $559,660 $391,402 $476,509 No L onger Notify ing P ilot in Comma nd $36,599,268 $25,595,997 $31,16 1 ,620 Total Cost Savings $37,358, 5 71 $ 26 ,132, 1 23 $31,762,828

We n o te that part 121. 1 25 an d 135 operato r s would updat e their tra i ning manuals to explain ne w p roced ures fo r id e n tif y in g POC s a ll owed o n ai rc r aft ( i.e. , iden t ificat io n o f th e PO C labe l). The Page 13

### FAA expec t s that this update wo ul d occur in the normal cycle of manu a l revision and th ere for e would not r es ult in additional cost for th e op erators. 

### IV. Cost s Proposed Approval Criteria and Requirement to A ffix a Label 

### To estimate th e costs to th e manuf act urers of affixing a lab el on th e d ev ic e, the FAA contacted manufacturer s that manuf ac ture PO Cs for us e on board a ircraft and rec eive d feed back from s ix I , 

### manu fac turers on labelling costs. -' Manufacturers confim1 e d that th ey currently permanently affix 1 4 

### labe l s that cou ld be modifi e d with new lan g ua ge at a one -ti me cost ranging fro m $200 

### to $10,200. 

### Th ese cost es tim ates from th e m c:mufacture rs ave ra ged $2,400 15 

### per 1 6 

### man ufacture r. 1 7 

### Bas ed on thi s feedback r e c ei ve d from manufac ture rs th e FAA est im ates th e labe lin g cost t o perman e ntl y affix a lab e l to contain th e ve rbia ge proposed in thi s rul e for a ll nine manufacturers i s abo ut $22 , 000. 

### V. Net Benefits Th e FAA ex pec t s positive net bene fits to r es ult from thi s proposal. The costs manufacturers wou ld save because th ey would not have to go through th e SF A R No . I 06 

### process ($1 08 , 000) 

### wou ld exceed th e added costs the POC m anu factu rin g indu s tr y would in c ur from hav in g to affix

1 3 Bas ed on th e manufact ure rs who have so ught FAA ap prova l for th eir POC s th e FAA bel ieves that the unive rse of pot e nt ia ll y affec t e d man uf ac turers is nine. 1 ' 1 Four of s ix m an uf ac ture rs ind ica ted the y permanent ly affix th e labe l, one said it ca nnot be tak en off eas il y and one said it w as pad print ed to th e plastic. 1 5 Some m an uf acture rs ind icated the cost mi g ht be more if they had to scrap exis tin g in ventory of labels , but we wo uld not consider th is a cos t of th e rul e because th ese ex is tin g lab e ls are not used t o d e monstrate compliance w ith the SFAR. Also , with ade qu ate noti ce that th e proposal wo ul d r equ ire a l a be l w ith specific verbiage manufacturers should be ab le to adjus t th e ir labe l o rd ers acco rdin g ly. 16 We assume th at manufacturers change the verb ia ge on one la bel that th ey can affix to a ll new devices and th erefore th ese are cos t s incurred per manufa cturer not per device. 1 7 Manufacturers cited per labe l costs ranging fro m 20 cents to one dollar. 

### Page 1 4a 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 $3 7.3 million.



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