33720 Federal Register / Vol. 65, No. 101 / Wednesday, May 24, 2000 / Proposed Rules

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Parts 121 and 135

[Docket No. FAA–2000–7119; Notice No. 00–

03]

RIN 2120–AG89

Emergency Medical Equipment

AGENCY: Federal Aviation

Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking

(NPRM).

SUMMARY: This action responds to the

Aviation Medical Assistance Act of

1998 by proposing that air carrier

operators carry automated external

defibrillators on large, passengercarrying aircraft and also augment

currently required emergency medical

kits. It would affect those operations for

which at least one flight attendant is

required and, if adopted, would require

instruction on the use of this

equipment. This proposal would modify

the regulations to include provisions

designed to provide the option of

treatment of serious medical events

during flight time.

DATES: Comments must be received on

or before September 21, 2000.

ADDRESSES: Comments on this

document should be mailed or delivered

in duplicate, to: U.S. Department of

Transportation Dockets, Docket No.

FAA–2000–7119, 400 Seventh Street,

SW., Room Plaza 401, Washington, DC

20590. Comments also may be sent

electronically to the Dockets

Management System (DMS) at the

following Internet address: http://

dms.dot.gov/. Commenters who wish to

file comments electronically, should

follow the instructions on the DMS web

site.

FOR FURTHER INFORMATION CONTACT: Judi

Citrenbaum, AAM–210, Aeromedical

Standards, Office of Aviation Medicine,

Federal Aviation Administration, 800

Independence Avenue, SW,

Washington, DC 20591, telephone (202)

267–9689.

SUPPLEMENTARY INFORMATION:

Comments Invited

Interested persons are invited to

participate in the making of the

proposed rule by submitting such

written data, views, or arguments as

they may desire. Comments relating to

the environmental, energy, federalism,

or economic impact that might result

from adopting the proposals in this

document are also invited. Substantive

comments should be accompanied by

cost estimates. Comments must identify

the regulatory docket or notice number

and be submitted in duplicate to the

DOT Rules Docket address specified

above.

All comments received, as well as a

report summarizing each substantive

public contact with FAA personnel

concerning this proposed rulemaking,

will be filed in the docket. The docket

is available for public inspection before

and after the comment closing date.

All comments received on or before

the closing date will be considered by

the Administrator before taking action

on this proposed rulemaking. Comments

filed late will be considered as far as

possible without incurring expense or

delay. The proposals in this document

may be changed in light of the

comments received.

Commenters wishing the FAA to

acknowledge receipt of their comments

submitted in response to this document

must include a pre-addressed, stamped

postcard with those comments on which

the following statement is made:

‘‘Comments to Docket No. FAA–2000–

7119.’’ The postcard will be datestamped and mailed to the commenter.

Availability of NPRMs

An electronic copy of this document

may be downloaded using a modem and

suitable communications software from

the FAA regulations section of the

Fedworld electronic bulletin board

service (telephone: 703–321–3339) or

the Government Printing Office (GPO)

electronic bulletin board service

(telephone: 202–512–1661).

Internet users may reach the FAA’s

web page at http://www.faa.gov/avr/

arm/nprm/nprm.htm or the GPO’s

webpage at http://www.access.gpo.gov/

nara for access to recently published

rulemaking documents.

Any person may obtain a copy of this

document by submitting 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. Communications must

identify the notice number or docket

number of this NPRM.

Persons interested in being placed on

the mailing list for future rulemaking

documents should request from the

above office a copy of Advisory Circular

No. 11–2A, Notice of Proposed

Rulemaking Distribution System, which

describes the application procedure.

Issue

The Aviation Medical Assistance Act

(the Act) was introduced in the United

States Congress on November 6, 1997.

Enacted April 24, 1998 [Pub. L. 105–

170, 49 USC 44701], the Act directs the

FAA to determine whether current

minimum requirements for air carrier

crewmember medical emergency

training and air carrier emergency

medical equipment should be modified.

Typically, when in-flight medical

events occur, airline passengers may be

assisted by crewmembers, generally

flight attendants working in the cabin,

and by other passengers. Flight

attendants frequently solicit the

voluntary advice and assistance of

medically qualified passengers, if on

board, to assist with serious medical

events. A basic emergency medical kit

and a basic first-aid kit are required to

be carried on board major air carriers

and are available for use. Additionally,

and if available, ground-based medical

advice may be solicited. If it is

subsequently recommended to divert

the flight, the pilot in command may

elect to land the aircraft.

With passenger enplanements

numbering over 600 million in 1998,

nearly double what they were in the

early 1980’s, an increase in passengers

needing in-flight medical assistance is

anticipated for the future. The overall

aging of the general population is

expected to result in a greater number

of air carrier passengers with medical

conditions, passengers who are more

likely to experience an in-flight medical

event.

The most commonly observed serious

in-flight medical events appear to be

cardiac in nature, due to chronic preexisting conditions or to the sudden

onset of previously unknown

conditions. Reporting seen in various

medical journals, as well as in the

popular press, reveals the following

about cardiac events in general:

• Cardiac arrest (the stopping of

effective pumping of blood by the heart)

reportedly strikes over 350,000

Americans every year, typically those 41

to 65 years old.

• The most common form of treatable

cardiac arrest (a substantial portion of

all cardiac events) is caused by an

abnormal heart rhythm called

‘‘ventricular fibrillation,’’ (where the

heart is still beating, although

ineffectively pumping blood).

Ventricular fibrillation is treatable with

defibrillation, electric shocks that

stimulate the heart to resume beating

normally.

• Survival of individuals undergoing

ventricular fibrillation can be as high as

90 percent in some circumstances, if

defibrillation is provided during the

first minute following collapse and

subsequent cardiac care is rapidly

provided.

Federal Register / Vol. 65, No. 101 / Wednesday, May 24, 2000 / Proposed Rules 33721

• For every minute that defibrillation

is delayed, survival is reported to fall

about 10 percent, dropping below 50

percent after 6 minutes.

• By providing early electrical

correction of ineffective heart pumping,

therapeutic defibrillation is more

effective than cardiopulmonary

resuscitation (CPR) in sustaining life

and function in certain situations.

In light of the aforementioned, and for

reasons elaborated in the discussion

below, the FAA is reviewing emergency

medical equipment and crewmember

emergency medical training

requirements.

Background

Automated External Defibrillators

Cardiac defibrillator technology has

progressed to the point that

defibrillation similar to that performed

in hospitals can, in many cases, be

accomplished effectively outside the

hospital environment by automated

external defibrillators (AED’s). When

activated, AED’s deliver a high energy

electrical pulse to attempt to restore the

normal electric heart activity required

for normal heart function. At a cost of

approximately $3,500 per unit, AED’s

are lightweight, compact, virtually

maintenance-free, and simple to use.

Because these battery-powered systems

voice-prompt step-by-step guidance,

appropriately trained non-medical

personnel may use them fairly

confidently to assist in certain,

especially treatable, cardiac

emergencies.

The type of AED most commonly

used can monitor a person’s heart

rhythm and prompt whether a shock

should be administered. The machine

determines whether, and when, an

individual needs to be administered an

electric shock. If defibrillation is needed

and is successfully performed, further

medical intervention is necessary to

determine the underlying cause for

definitive treatment.

CPR is a necessary adjunct to AED

usage as it may be the only effective

assistance available. CPR should be

initiated immediately upon

encountering any apparent cessation of

breathing or cardiac arrest (in an

attempt to maintain a person’s oxygen

flow) and must be continued in the

event of any of the following: the AED

voice-prompt indicates ‘‘no shock,’’ and

a pulse is absent; three AED shocks are

administered to no avail; the AED

malfunctions. As some cardiac events

will not be treatable by AED, it is vital

that CPR be started and performed as

long as necessary.

Some non-medical professionals,

among them police officers and fire

fighters, have the devices available and

are trained to use them. The U.S. Food

and Drug Administration (FDA)

regulates the use of AED’s and began

approving use of the devices in an

aircraft environment in September 1996.

Subsequent to this approval, several air

carriers voluntarily have begun or have

announced plans to carry them on

board.

Emergency Medical Kits

In 1986, the FAA promulgated a final

rule, ‘‘the Emergency Medical

Equipment Requirements Rule,’’

requiring large, passenger-carrying

aircraft to carry emergency medical kits

[51 FR 1218; January 9, 1986, effective

August 1, 1986]. The FAA set a

minimum standard for kit contents

requiring the following: a

sphygmomanometer, which is an

instrument for measuring blood

pressure; a stethoscope; three different

sizes of oral airways (breathing tubes);

syringes; needles; 50 percent dextrose

injection, for hypoglycemia or insulin

shock; epinephrine, for asthma or acute

allergic reactions; diphenhydramine, for

allergic reactions; nitroglycerin tablets,

for cardiac-related chest pain; and basic

instructions on the use of the drugs.

The rule has been amended once, in

October 1994, [59 FR 52640; October 18,

1994], to require protective gloves. Also,

in January 1996, under the ‘‘Commuter

Rule,’’ commuter air carriers operating

20-to-30-seat airplanes, that previously

were required to carry only first-aid kits,

have been required to carry the

emergency medical kit described above

[60 FR 65831, December 20, 1995].

At the time the emergency medical kit

rule was promulgated, there was

controversy over what types of

instruments and medications the FAA

should require since some commenters

to the proposed rule expressed concerns

about controlled substances (originally

proposed for the action) being stowed

on board any passenger aircraft. It was

argued that an aircraft should not be a

flying hospital, but that the proper

course of action in the event of an onboard medical emergency is for the pilot

in command to decide if the aircraft can

be landed safely to allow the ailing

passenger to receive appropriate

medical care. As a result of these

concerns, the FAA scaled down its

original proposal in terms of the

contents that would be required of

emergency medical kits. The rule

promulgated was designed to ensure

that, at the very least, U.S.-registered

aircraft would have the basic, minimum

equipment on board if the crew chose to

attempt treatment and/or to aid in

decisions regarding diversion. The rule

also required airlines to report to the

FAA principal operations inspector, for

a period of 24 months after the effective

date of the rule, information on each

medical emergency occurring during

flight time and resulting in the use of

the emergency medical kit or the

diversion of aircraft.

Related Studies

The FAA’s Civil Aeromedical

Institute (CAMI), located in Oklahoma

City, has conducted four specific studies

on in-flight medical emergencies and

the use of the emergency medical kit.

These technical reports, issued by CAMI

in 1991, 1997, and 2000, are described

briefly below. Copies of the CAMI

reports are available for review in the

public docket established for this

rulemaking action.

CAMI Technical Reports

• ‘‘Response Capability During Civil

Air Carrier In-flight Medical

Emergencies’’ [March 1991; DOT/FAA/

AM–91/3] and ‘‘Utilization of

Emergency Kits by Air Carriers.’’ [March

1991; DOT/FAA/AM–91/2].

The former report reveals the

preliminary findings and the latter

report reveals the comprehensive

findings of data collected from part 121

air carriers on medical emergencies. As

described above, ‘‘The Emergency

Medical Equipment Requirements Rule’’

issued in 1986 required that, for a 2-year

period, all part 121 air carriers maintain

records on each medical event occurring

during flight time which resulted in the

use of the emergency medical kit,

diversion of the aircraft, or death of a

passenger or crewmember.

During the 2-year monitoring period,

a total of 2,322 medical events were

documented (equating to approximately

three per day) with 33 deaths reported.

In the 2,293 actual uses of the medical

kit, a physician was the provider in over

85% of the cases. The most common

presenting symptom was pain, followed

by unconsciousness, impaired

breathing, nausea and/or vomiting; the

most common presenting ‘‘sign’’ was

described as a ‘‘myocardial problem.’’

Although only 2 years of data were

available for review, the pattern of

medical kit item usage was very similar

in the first and second years. An

increase in the number of cases also was

noted in the second year. The FAA did

not find justification to make any

modifications to the emergency medical

kits following the 2-year regulatory

reporting period.

33722 Federal Register / Vol. 65, No. 101 / Wednesday, May 24, 2000 / Proposed Rules

1The Act requires the Administrator to make a

decision on requiring AD’s at airports, as well as on

air carrier aircraft. The Act recognized that the

decision on requiring the devices for airports may

be in a form different than the decision for air

carriers. As a result, the FAA decided to undertke

separate efforts in gathering and analyzing

information for airports and air carrier aircraft. A

cardiac event on an aircraft occurs in a totally

different environment from a cardiac event that

occurs on an airport. This NPRM applies only to air

carriers. A decision on whether or not to require

AED’s at airports will be issued separately.

• ‘‘In-flight Medical Care, An

Update’’ [February 1997; DOT/FAA/

AM–97/2].

From 1990 to 1993, CAMI obtained

information from two airlines and two

in-flight medical care delivery

companies to determine which category

of in-flight medical event occurred most

frequently and which category

accounted for the greatest number of

diversions. The trend in the frequency

of diversions for medical reasons also

was assessed. The effect of in-flight

medical advice was then evaluated by

comparing the number of diversions

that resulted in hospitalizations to the

number that did not. The findings

showed that neurological, syncopal, and

cardiac episodes respectively, were the

most frequent categories of medical

emergencies encountered in flight,

while cardiac, neurological, and

respiratory events, in that order,

accounted for the most diversions.

• ‘‘The Evaluation of In-flight

Medical Care Aboard Selected U.S. Air

Carriers from 1996 to 1997’’ [April 2000;

DOT/FAA/AM–00/13].

• CAMI analyzed 1,132 in-flight

medical incidents that occurred

between October 1, 1996, and

September 30, 1997. The data included

information from six airlines that

accounted for approximately 20 percent

of all U.S. domestic enplanements for

the period. This study was not designed

to provide an in-depth review of inflight medical care delivery; however,

the data did reveal that in-flight

diagnoses by ground-based physicians

frequently can be in close agreement

with hospital discharge diagnoses,

indirectly implying that the proper

diagnosis was made in flight. In

particular, in the case of cardiac

patients, the agreement rate was 94.1

percent, and passengers appeared to be

conservatively diagnosed and treated in

flight. Many of these in-flight diagnoses

were made with the assistance of a

ground-based physician.

Additionally, this study suggested

that the items that should be considered

for possible addition to a future medical

kit include a bronchodilator inhaler, an

oral antihistamine, and some form of

oral non-narcotic analgesic medication.

These items are not commonly available

because they are not routinely carried

by other passengers or the airline. No

data were collected in this study

concerning AED’s as they were not

being carried on board at the time of the

study. As a result, no consideration was

given to adding cardiac drugs to the

emergency medical kit for use after an

AED intervention.

Related Activity

In 1995, in light of changing

demographics of air carrier passengers

and advances in clinical medicine, some

FAA physicians began an informal

analysis of in-flight medical events.

These physicians explored the issue

with individual air carriers, the

Aerospace Medical Association (AsMA),

the Air Transport Association (ATA),

and MedAire, Inc. (a for-profit firm that

provides medical advice to flight crews

through air-to-ground communication

links). The physicians did not produce

any written technical reports or

recommend any regulatory changes;

they merely gathered information on the

issue.

In May 1997, the U.S. House of

Representatives Committee on

Transportation and Infrastructure,

Subcommittee on Aviation, held

hearings on in-flight medical events.

Witnesses who testified at these

hearings strongly supported additional

crew training and the inclusion of

AED’s in the onboard medical

equipment.

In August 1997, AsMA convened a

task force of physicians across the major

medical specialties to review the

contents of emergency medical kits.

This task force recommended certain

minimum medications and medical

supplies for air carriers. The group

further recommended that air carriers

consider AED’s on wide body aircraft

for use on specific routes, particularly

lengthy or over-water flights. It was

recommended that AED’s be tested for

their possible effects on installed

avionics and that airlines use an

appropriate training program with

particular attention given to safety

considerations of in-flight use. These

recommendations were based on a

survey of 2,300 AsMA physicians who

had treated at least one passenger on a

commercial flight.

In December 1997, an ATA Medical

Panel recommended that ATA member

airlines place AED’s on at least 20

percent of the aircraft in their fleets

(initially), upgrade emergency medical

kits, and modify flight attendant

training on the use of this equipment.

(In forming this recommendation, this

ATA group collected information from

nine member airlines on in-flight

medical emergencies and medical kit

usage.)

In January 1998, the FAA received a

petition for rulemaking from a physician

who had assisted a passenger on board

a December 1997 flight who apparently

suffered a fatal heart attack. The

petitioner requested that the FAA take

action to upgrade emergency medical

equipment being carried on board major

air carriers.

On April 24, 1998, the Aviation

Medical Assistance Act of 1998 (the

Act), Pub. L. 105–170, 49 U.S.C 44701,

was enacted. The Act directs that the

FAA take the following action:

• Evaluate the equipment required to

be carried in air carrier emergency

medical kits and the training of flight

attendants on the use of such

equipment; issue a Notice of Proposed

Rulemaking (NPRM) if regulations need

to be modified.

• Collect data for 1 year from a major

air carrier on medical emergencies that

result in death and any information

necessary to determine whether AED’s

should be required on board air carriers

(with a maximum payload capacity of

more than 7,500 pounds) and/or at

airports.

• Following an analysis of the results

of the data collection, determine

whether to issue one of the following:

an NPRM to require AED’s on air

carriers (with a maximum payload

capacity of more than 7,500 pounds)

and/or at airports; 1 a recommendation

to Congress for legislation; or a notice in

the Federal Register that would indicate

why this action is not required.

• Issue a final rule within 120 days

following the date on which comments

are due on an NPRM. The Act includes

a ‘‘Good Samaritan’’ provision that

limits air carriers’’ liability in obtaining

medically qualified non-employee

passengers to assist persons. The ‘‘Good

Samaritan’’ provision limits nonemployee passenger liability for

providing assistance during an in-flight

medical event unless the assistance is

grossly negligent, or is willful

misconduct.

In September 1998, in a letter sent to

the Federal Air Surgeon, the Association

of Flight Attendants (AFA) discussed

the potential implications of the Act on

its members.

On December 10, 1999, the FAA held

a public meeting on airline workplace

safety. Some flight attendants who

spoke at the meeting stated that, based

on their personal experiences in

handling in-flight medical events,

currently required emergency medical

equipment needs to be enhanced.

Federal Register / Vol. 65, No. 101 / Wednesday, May 24, 2000 / Proposed Rules 33723

A copy of the information provided to

the FAA on the recommendations from

the AsMA and the ATA Medical Panels,

as well as a copy of the petition, the Act,

and the AFA letter have been placed in

the public docket established for this

proposal. Information provided to the

FAA at the December 10, 1999, public

meeting is available under Docket

number FAA–1999–6342.

July 1, 1998, to June 30, 1999, Data

Collection

On July 1, 1998, the FAA initiated a

data collection, as directed in the Act,

to gather information on in-flight

medical events that result in death or

threat of death. The FAA developed a 1-

page checklist, the ‘‘In-Flight Medical

Event Report,’’ (the event report)

designed for the use of nonmedical

professionals such as crewmembers. (A

copy is on file in the docket.) The FAA

asked the ATA and several flight

attendant unions to review the event

report. The ATA agreed to distribute the

event reports among its members, to

collect any input received, and to

forward it to the FAA on a quarterly

basis. Up to 15 different ATA-member

airlines, carrying approximately 85% of

U.S. domestic airline passengers,

contributed some data throughout the

year.

The event report was intended to

record incidents that were likely to be

of cardiac origin and, thus, possibly

require use of an AED. As other medical

conditions may have similar symptoms,

additional checklist choices were

provided in an attempt to distinguish

non-cardiac problems.

Based on the symptoms, treatment,

and follow-up information on the event

report, a general medical category was

assigned to each event. In an effort to

indicate more specifically when an AED

may have been useful, a category also

was assigned based only on symptom

and in-flight treatment information. In

some cases, this assignment was not

possible because of the limited or

incomplete information provided. A few

reports included a specific follow-up

diagnosis based on a hospital

evaluation.

Data collected for the Act resulted in

the submission of 188 in-flight medical

event forms, not including 15 that were

provided in an unusable format. Of the

188 events, 177 events occurred on the

aircraft (either in flight, at the gate, or

while taxiing), 10 events occurred on

the ground (either in the jetway or the

terminal) and one event occurred in a

taxi enroute to the airport. A total of 108

deaths were reported (out of the 188

total events) either by the end of the

flight or after the passenger was

transferred to a hospital. Of the 80

remaining events, 14 passengers were

reported as being alive, 56 were

reported on the event report as

‘‘Unknown,’’ and 10 were submitted

with no outcome reported.

Of the 177 events that occurred on the

aircraft, 119 were thought to be of

cardiac origin based on a review of all

the information provided on the event

reports. (The average age of those

passengers on the aircraft with reported

cardiac problems was 62 years.) Sixtyfour of these 119 passengers were

reported as having died. For the

remainder, 42 passengers had unknown

dispositions and 10 passengers were

reported as having survived. Three

events had unreported results.

The AED was used to deliver at least

one shock in 17 separate events, 14 on

the aircraft and three on the ground.

From these events, four passengers were

reported as having survived, 11 as

having died, and two as having

unknown outcomes. It is believed the

AED use was the event that changed the

outcome for those who were reported as

having survived. For cardiac-related

events on the aircraft, an AED was

reported as ‘‘Not available’’ for 40

events, ‘‘Not needed’’ for 12 events, and

‘‘Not reported’’ for 40 events.

CPR was reportedly performed 82

times on the aircraft.

A total of 74 diversions for passenger

medical emergencies were reported; 52

for cardiac events.

While not a primary focus of this data

collection, aircraft emergency medical

kit item usage also was reported: six

uses of epinephrine and six uses of

nitroglycerin. (Both epinephrine and

nitroglycerin currently are required to

be carried in the emergency medical

kits.) Intravenous (IV) saline and

atropine (neither currently required by

the FAA but carried by some airlines)

were reported used once each. All

events reporting these medications were

apparent cardiac problems.

Overall, 156 (of the total 188) events

reported some type of medical

assistance being provided on board the

flight, although the actual number may

be somewhat lower as it was impossible

sometimes to determine whether a

reported paramedic or emergency

medical technician was a passenger or

part of the ground response team.

Physicians were reported available on

the aircraft for 92 events, nurses for 49

events.

As is common when collecting this

type of information, the data have

multiple limitations. The accuracy of

the data provided appeared highly

variable, and analysis to assign a

specific medical category often was

difficult or impossible. Early in the data

collection, various draft iterations of the

event report were submitted that were

slightly different from the final event

report adopted for use. Because a

limited data form was used (so that the

data collection would not be overly

burdensome), ambiguity with respect to

precise symptom reporting was allowed.

Reports often were incomplete, resulting

in additional uncertainty about the type

of event. Finally, no method exists for

confirming whether participating air

carriers reported every death or neardeath event or whether privacy

constraints may have limited the

information in the event reports

submitted to the FAA.

The availability of AED’s changed

through the year as more airlines began

carrying them on their aircraft. For this

reason, it was not possible to determine

the number of aircraft carrying AED’s at

any point during the data collection.

Additionally, the number of airlines

submitting data varied for each quarter

of data collection with some airlines

reporting no events in later quarters.

The survival rate may have been greater

than the four possible lives saved if

AED’s had been aboard each aircraft of

each participating air carrier throughout

the data collection. If the survival rate

during the test period had been higher,

then the projected number of lives that

potentially could be saved over time

would be higher; however, this cannot

be established from the data received

during the July 1998-June 1999

timeframe.

In spite of these limitations, however,

the FAA can conclude from the data

collection that deaths occur on air

carriers and that certain medical

interventions can be useful and may

change the outcome for some.

Given the normal circumstances of

flight (e.g., reduced air pressure,

reduced humidity, high ambient noise

levels, reduced space, possible air

turbulence, delayed access to the most

effective hospital care, etc.) the aircraft

is a difficult environment in which to

treat a serious medical event, cardiac or

otherwise. When serious medical

incidents do occur in flight, however,

having enhanced emergency medical

equipment available may facilitate the

response of flight attendants, and others

who may volunteer to assist them.

General Discussion of the Proposal

The data collection revealed that four

passengers who were administered at

least one AED shock during flight

survived and the FAA has confirmed

that these passengers continue to

survive. Subsequent to the data

collection, further FAA investigation

33724 Federal Register / Vol. 65, No. 101 / Wednesday, May 24, 2000 / Proposed Rules

has revealed that more passengers, and

a flightcrew member, have had similar

experiences. Therefore, the option of not

requiring action appears inappropriate.

The FAA reviewed various ways of

proposing this action before deciding on

what it determined would be an

appropriate course of action. In

particular, the FAA considered an

action that would amend 14 CFR part 91

to allow specifically the use of AED’s on

board aircraft. It was determined that

this action would not be adequate,

however, because it would not address

issues such as maintenance and safe and

appropriate usage of the device. The

FAA determined that, to provide for the

safe carriage and appropriate usage of

AED’s, it was necessary to amend part

121 to modify current emergency

medical equipment and emergency

medical training requirements to

appropriately address AED usage.

Therefore, the FAA is proposing that

all air carriers operating passengercarrying airplanes under part 121 with

a maximum payload capacity of more

than 7,500 pounds, and required to have

at least one flight attendant on board,

take the following actions:

• Have at least one AED on board

each flight.

• Require initial and recurrent

training for all flight attendants on AED

usage and in CPR.

• Require initial training for all pilots

on the location of the AED and its

instruction set.

• Enhance emergency medical kits to

include the following additional

medications: non-narcotic analgesic

(such as acetaminophen, 325 mg, or

ibuprofen, 200 mg, or equivalent); oral

antihistamine (such as

diphenhydramine, 25 mg or equivalent);

aspirin (325 mg); atropine (0.5 mg, 5cc

single dose ampule or equivalent); a

bronchodilator inhaler (such as

albuterol, metered dose inhaler or

equivalent); lidocaine (5 cc, 20 mg/ml,

injectable, single dose ampule or

equivalent) and saline solution (500 cc)

for intravenous infusion.

• Enhance emergency medical kits to

include the following additional

equipment: an IV administration kit

with connectors (and, for placing the IV,

alcohol sponges, tape, bandage scissors,

and a tourniquet); a self-inflating

manual resuscitation device with three

sizes of masks (one pediatric, one small

adult, one large adult), such as an

AMBU bag; and three sizes of CPR

masks (one pediatric, one small adult,

one large adult).

• Require initial, familiarization

training on enhanced emergency

medical kit content for all

crewmembers.

It should be noted that the decision to

offer treatment or take other action

(including safe diversion of the aircraft)

is discretionary with the air carrier and

its agents. While the FAA believes that

this action is justified, it is also aware

that adding enhancements to the

medical kit could result in their

unintentional misuse. Passenger

expectations regarding the level of

medical care should not be

unrealistically raised by this action.

Onboard medical assistance will

continue to be discretionary as well as

limited and must be regarded as

emergency treatment with no unrealistic

expectations of favorable outcomes for

passengers having medical events in

flight. The FAA believes that it is

unrealistic to expect crewmembers to

achieve the same level of proficiency as

emergency medical personnel who

perform medical procedures routinely

on a daily basis.

It is recognized that the availability of

these enhancements (equipment and

medication) will not eliminate the

logistical and medical difficulties

experienced in attempting to treat a

stricken passenger effectively while in

flight. The intent of the regulation is to

provide options for treatment, not to

raise expectation in the passenger or

physician community regarding the

level of medical care available in flight.

Section-by-Section Discussion of the

Proposal

The FAA proposes to amend 14 CFR

part 121 by adding subpart X and by

amending appendix A and the following

sections: §§ 121.303, 121.309, 121.323,

121.325, 121.415, 121.417, 121.427. A

minor editorial amendment is proposed

for part 135 under § 135.177. These

modifications are described below.

Section 121.303 Airplane Instruments

and Equipment

Paragraphs (b) and (d) of § 121.303

currently address airworthiness

requirements and operable conditions

for airplane instruments and equipment.

Under this proposal, paragraphs (b) and

(d)(2), which reference other sections

including § 121.309, would be modified

to include a reference to proposed

§ 121.803.

Section 121.309 Emergency Equipment

Paragraph (d) of § 121.309 currently

addresses first aid and emergency

medical equipment and protective

gloves. Under this proposal, the

provisions would be moved to proposed

subpart X, and paragraph (d) of

§ 121.309 would be removed and

reserved.

Section 121.323 Instruments and

Equipment for Operation at Night

Section 121.323 currently addresses

instruments and equipment for

operations at night. The introductory

paragraph references other sections

including § 121.309. Under this

proposal, the introductory paragraph

would be modified to include a

reference to the proposed § 121.803.

Section 121.325 Instruments and

Equipment for Operations Under IFR or

Over-The-Top

Section 121.325 currently addresses

instruments and equipment for

operations under IFR or over-the-top.

The introductory paragraph references

other sections including § 121.309.

Under this proposal, the introductory

paragraph would be modified to include

a reference to proposed § 121.803.

Section 121.415 Crewmember and

Dispatcher Training Requirements

Paragraph (a)(3) currently requires

each training program to provide ground

training, including emergency training

for crewmembers as specified in

§ 121.417. Under this proposal,

paragraph (a)(3) would be modified to

reference emergency training specified

in both § 121.417 and proposed

§ 121.805.

Section 121.417 Crewmember

Emergency Training

Paragraph (b)(2)(ii) currently requires,

in part, that crewmembers receive

individual instruction in the location,

function, operation, and proper use of

first aid equipment. Paragraph (b)(3)(iv)

currently requires, in part, that

crewmembers receive instruction in

handling ‘‘illness, injury, or other

abnormal situations’’ involving

passengers or crewmembers and that

this training include familiarization

with the emergency medical kit. Under

this proposal, the provisions would be

modified and moved to proposed

subpart X. Paragraphs (b)(2)(ii) and

(b)(3)(iv) of § 121.417 therefore would

be removed and reserved.

Section 121.427 Recurrent Training

Paragraph (b)(2) of § 121.427 currently

requires recurrent training instruction,

as necessary, in the subjects required for

initial ground training by § 121.415(a),

as appropriate, including emergency

training (not required for aircraft

dispatchers). Under this proposal,

paragraph (b)(2) would be modified to

reference emergency training specified

in proposed § 121.805.

Federal Register / Vol. 65, No. 101 / Wednesday, May 24, 2000 / Proposed Rules 33725

Subpart X Emergency Medical

Equipment and Training

Under this proposal, subpart X would

be added to part 121 to describe

emergency medical equipment and

requirements for instruction applicable

to all certificate holders operating

certain passenger-carrying airplanes.

These requirements would include

existing requirements for emergency

medical equipment and training that

would be modified and moved to this

new subpart. Section 121.803 paragraph (a) would

adopt existing § 121.309(a) requirements

and add the words ‘‘unless authorized

by the Administrator.’’ These words

would be added to cover situations in

which an AED may be inoperable or not

available for flight. In such cases, the

certificate holder would have to obtain

approval from the FAA principal

operations inspector before operating a

flight. Section 121.803 paragraph (b) would

adopt provisions of existing § 121.309

(b) regarding inspection, accessibility,

and marking requirements for

emergency equipment. Section 121.803 paragraphs (c)(1) and

(2) would require each passengercarrying airplane to have approved firstaid kits and a modified emergency

medical kit (in airplanes for which a

flight attendant is required). The

required minimum number of first-aid

kits is specified under part 121,

appendix A, as are the specifications

and requirements for the emergency

medical kit. This requirement is

currently specified in paragraph (d) of

§ 121.309.

Paragraph (c)(3) of § 121.803 is a new

provision that would require, in

airplanes for which a flight attendant is

required, an approved AED. Paragraph (b)(2) of § 121.805 would

include a provision that all

crewmembers be instructed in the

location, function, and operation of

emergency medical equipment which,

under the proposal, would include

modified emergency medical kits and

AED’s. This requirement is currently

specified in paragraph (b)(2)(ii) of

§ 121.417.

Paragraph (b)(3) of § 121.805 would

include a provision that all

crewmembers be instructed in the

handling of emergency medical events

involving passengers or crewmembers to

include familiarization with the

emergency medical kit, as modified

under the proposal. This requirement is

currently specified in paragraph

(b)(3)(iv) of § 121.417.

Paragraph (b)(4) of § 121.805 would

include additional provisions for flight

attendants that would require

appropriate instruction in the proper

use of AED’s; appropriate instruction in

CPR; and appropriate recurrent training

in the use of AED’s and in CPR. All

emergency medical training would have

to be completed before 36 months after

the effective date of the rule. The

instruction required under proposed

§ 121.805(b)(4) would be in addition to

the programmed hours of training

required for flight attendants under

§ § 121.421 and 121.427.

Specific training-hour requirements

are not proposed under this regulatory

action. Since some air carriers have

already voluntarily enhanced

emergency medical response

capabilities and have initiated and

implemented specific training programs,

it would be overly burdensome to try to

standardize training. The FAA

anticipates, however, that the initial and

recurrent instruction that would be

needed in CPR and in AED usage would

conform to national programs

conducted for ground-based trainees

who initially certify and recertify in

CPR procedures and AED usage. These

national programs would include those

offered, for example, by the American

Heart Association or the American Red

Cross. The FAA proposes that recurrent

instruction in the proper use of AED’s

and in CPR procedures be conducted at

least once every 24 months.

It is expected that some time will be

required for air carriers to modify

training programs, to enhance

emergency medical kits and associated

protocols, and to procure AED’s.

Therefore, the agency is proposing that

a final rule take effect 36 months after

publication. This would mean that the

required training must be completed

within 36 months after the effective date

and before compliance is required.

Appendix A to Part 121-First-Aid Kits

and Emergency Medical Kits

Appendix A sets forth the

specifications and requirements for firstaid kits and emergency medical kits.

Under this proposal, appendix A would

be amended to include an AED and

proposed enhancements to the

emergency medical kit. The appendix

also would be revised for overall clarity;

specific amendments are described

below.

‘‘First-Aid Kits’’

The reference to ‘‘Federal

Specification GG-K–391a’’ would be

deleted. This reference is obsolete as the

specification was cancelled as of July 6,

1986. No changes are proposed for

either the quantity of kits required or

the content.

‘‘Emergency Medical Kit’’

This section would be amended to

propose that the following be included

in an approved emergency medical kit:

Medications: oral antihistamine, nonnarcotic analgesic, aspirin, atropine, a

bronchodilator, additional epinephrine,

lidocaine, and saline for intravenous

infusion.

Equipment: an IV administration kit

with connectors (and, for placing the IV,

alcohol sponges, tape, bandage scissors,

and a tourniquet); a self-inflating

manual resuscitation device with three

sizes of masks (1 pediatric, 1 small

adult, and 1 large adult), such as an

AMBU bag; and three sizes of CPR

masks (1 pediatric, 1 small adult, and 1

large adult).

Paragraph (4) under ‘‘Emergency

Medical Kits’’ would be removed. This

paragraph was added under 1994 action

to require protective gloves. Because all

affected air carriers have now complied

with the requirement, the compliance

date is no longer needed and may be

removed. It should be noted, however,

that the FAA proposes to change the

reference to protective gloves from

‘‘protective latex gloves or equivalent’’

to ‘‘protective nonpermeable gloves or

equivalent.’’ When the emergency

medical kit action was first adopted,

potential for allergic reaction to latex

was not clear. Because there may be a

potential for allergic reaction to latex,

however, the FAA has determined that

it would be best to remove the reference

to latex under this action.

Rationale for Amending the Emergency

Medical Kits

The FAA’s study entitled ‘‘The

Evaluation of In-Flight Medical Care

Aboard Selected U.S. Air Carriers from

1996 to 1997,’’ reveals that an oral

antihistamine (used mainly to relieve

symptoms associated with allergies and

hay fever), a non-narcotic analgesic

(used mainly to relieve muscle aches

and headaches), and a bronchodilator

inhaler (used to help restore normal

breathing in asthmatics) are appropriate

for inclusion in air carrier emergency

medical kits.

The FAA consulted with the

University of Oklahoma, Department of

Biostatistics and Epidemiology in

analyzing the data received for this

study. Frequency response and

contingency analyses were performed,

giving special attention to items that are

not part of the currently mandated

emergency medical kit that were used

during in-flight medical events. If such

items appeared to have been obtained

and used frequently, it suggested that

they should be considered for inclusion.

33726 Federal Register / Vol. 65, No. 101 / Wednesday, May 24, 2000 / Proposed Rules

Upon review of the data, researchers

determined that additional items should

be considered for inclusion in the

medical kit if the item was used in more

than 1 or 2 percent of all cases. After

identifying items that might be

considered for inclusion in the medical

kit, their effect on in-flight medical care

was investigated. Of those items that

potentially could be added to the kit, a

bronchodilator inhaler and an oral

antihistamine appeared to have the

greatest effect on passengers; analgesic

therapy also showed effective results.

The recent data collection mandated

by the Act did not reveal a need for any

further modification of the emergency

medical kits. Nitroglycerin and

epinephrine, already required items,

were the medications most commonly

reported as being used. Atropine and IV

saline were used one time each.

Because the FAA proposes to require

AED carriage, however, it is appropriate

to require the following items in the

emergency medical kits that might be

useful to medical personnel who may

treat a stricken passenger(s):

Aspirin: a general oral medication that

may be needed to alleviate head and

muscle aches and, possibly, a cardiac

event.

Atropine: a drug, most effectively

administered intravenously and used to

increase heart rate, that may be needed

to assist a passenger with an unstable

cardiac rhythm.

Lidocaine: a drug, most effectively

administered intravenously, that may be

needed in cases of unresponsiveness to

defibrillation and possibly for

maintenance of normal heart rhythm

after successful defibrillation.

An IV administration kit with

connectors (and, for placing the IV,

alcohol sponges, tape, bandage scissors,

and a tourniquet): for administering IV

drugs (e.g., atropine or lidocaine) that

may be needed to sustain heart function.

A self-inflating manual resuscitation

bag (with 3 masks: 1 pediatric, 1 small

adult, and 1 large adult): that may be

needed for continuation of respiratory

support.

CPR masks (1 pediatric, 1 small adult,

1 large adult): that may be needed if

CPR is required.

The FAA has determined that these

additions are justified based on the

proposed addition of the AED and on

best medical practice. It should be noted

that an additional preparation of

epinephrine, a drug that may be used for

heart stimulation, also is being

proposed. This additional preparation is

intended to complement the dosage of

epinephrine currently required which is

intended for use as a muscle relaxant.

Comments on these proposed

additions to the emergency medical kits

are specifically invited.

‘‘Approved’’ first-aid kit and

‘‘approved’’ emergency medical kit

would continue to mean that the FAA

principal operations inspector assigned

to the holder of an operating certificate

exercises approval for the

Administrator, as appropriate, of

equipment to be carried aboard a

certificate holder’s aircraft.

‘‘Automated External Defibrillator’’

This section would be added to set

forth AED specifications. Currently,

AED’s are powered by primary (not

rechargeable) lithium batteries. Safety of

these batteries is stressed because

extremely energetic materials are used

in lithium cells and they are not

intrinsically safe. Safety concerns

include the possibility of fire, explosion,

and the venting of toxic or flammable

gases. In this regard, and given the

limitations of the aircraft environment,

AED carriage on aircraft presents special

circumstances in terms of the storage of

the device and proper maintenance.

Therefore, certificate holders must be

vigilant about inspecting and visually

checking the device and its battery on

a regular basis. The FAA proposes to

enhance the level of safety by requiring

that certificate holders comply with all

requirements in applicable Flight

Standards Information Bulletins for

Airworthiness, such as the one for

medical portable electronic devices

(FSAW 98–05), and in applicable

Technical Standard Orders, such as the

one for lithium batteries (FAA TSO–

C142).

‘‘U.S. Food and Drug Administrationapproved AED’’ would mean that the

U.S. Food and Drug Administration has

approved the device for medical use and

that the device conforms to its

standards. ‘‘Otherwise approved by the

Administrator’’ would mean that

certificate holders would have to seek

individual approval from FAA principal

operations inspectors for power sources

for which an FAA TSO does not exist.

Section 135.177 Emergency Equipment

Requirements for Aircraft Having a

Passenger Seating Configuration of More

Than 19 Passengers

This section would be amended to

remove the obsolete reference to

‘‘Federal Specification GG–K–391a’’ and

to generally conform to clarifying

language proposed for part 121,

appendix A. No content changes are

proposed under this action.

Paperwork Reduction Act

In accordance with the Paperwork

Reduction Act of 1995 (44 U.S.C. 3507

(d)), the FAA has determined that there

are no requirements for information

collection associated with this proposed

rule.

International Compatibility

In keeping with U.S. obligations

under the Convention on International

Civil Aviation, it is FAA policy to

review International Civil Aviation

Organization (ICAO) Standards and

Recommended Practices (SARP’s) and

to comply to the maximum extent

possible.

ICAO Standard (Annex 6, Part 1,

Chapter 6, Section 6.2.2) states that

airplanes shall be equipped with

‘‘accessible and adequate medical

supplies appropriate to the number of

passengers the aeroplane is authorized

to carry.’’ ICAO Recommended Practice

(Annex 6, Part 1, Chapter 6, Section

6.2.2) states that medical supplies

should comprise ‘‘one or more first-aid

kits’’ and ‘‘a medical kit for the use of

medical doctors or other qualified

persons in treating in-flight medical

emergencies for aeroplanes authorized

to carry more than 250 passengers.’’

Attachment B to this Recommended

Practice lists, in part, the ‘‘typical

contents’’ of first-aid kits and emergency

medical kits.

Part 121, Appendix A, as currently

drafted, complies with these ICAO

SARP’s insofar as first-aid kits and

emergency medical kits are required to

be carried. Part 121, Appendix A does

not include all ICAO-recommended

emergency medical kit items under

ICAO Attachment B, however, and does

not specify who is authorized to use the

emergency medical kit.

The FAA proposes to add to the

emergency medical kits those items

warranted for inclusion as a result of its

study entitled ‘‘The Evaluation of InFlight Medical Care Aboard Selected

U.S. Air Carriers from 1996 to 1997’’

and those items necessary to support

AED protocol. The FAA concurs with

the recommendation that emergency

medical kits be used by qualified and

trained personnel only. Adding such a

requirement to part 121, however,

would involve defining the various

medical specialties and, perhaps,

limiting access to the extent that the

only person available to assist on a

flight might not be included.

ICAO Standard (under Annex 6, Part

1, Chapter 12, Section 12.4) states, in

part, that cabin attendants shall

complete training programs that ensure

that each person is ‘‘drilled and capable

Federal Register / Vol. 65, No. 101 / Wednesday, May 24, 2000 / Proposed Rules 33727

in the use of emergency and life-saving

equipment required to be carried, such

as . . ., first-aid kits.’’ Existing § 121.417

and proposed 121.805 comply with

these ICAO guidelines.

ICAO SARPS do not address AED

usage on aircraft.

Regulatory Evaluation Summary

Changes to Federal regulations must

undergo several economic analyses.

First, Executive Order 12866 directs 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 requires agencies to analyze the

economic effect of regulatory changes

on small entities. Third, OMB directs

agencies to assess the effect of

regulatory changes on international

trade. In conducting these analyses, the

FAA has determined this proposed rule

is a ‘‘significant regulatory action’’

under section 3 (f) of Executive Order

12866 and, therefore, is subject to

review by the Office of Management and

Budget. This proposed rule is

considered significant under the

regulatory policies and procedures of

the Department of Transportation (44 FR

11034, February 26, 1979). This

proposed rule would not have a

significant impact on a substantial

number of small entities. Furthermore,

this proposal would not constitute a

barrier to international trade. The FAA

invites the public to provide comments

and supporting data on the assumptions

made in this evaluation. All comments

received will be considered in the final

regulatory evaluation.

Benefits

The proposed rule is intended to

require equipment that might preserve

the lives of passengers who have serious

cardiac medical events on board

commercial airplanes operating under

part 121 for which a flight attendant is

required and with a maximum payload

of more than 7,500 pounds. This

proposal would require certain

passenger-carrying air carrier operators

to carry AED’s on board their aircraft

and to augment currently required

emergency medical kits with additional

medications and medical equipment.

Another requirement of this proposal is

to augment the emergency medical

training of crewmembers, in particular

flight attendants and those who may

assist them, for responding to in-flight

medical events.

Medical reporting shows that the

chances of surviving ventricular

fibrillation, a critical cardiac event, are

enhanced by the application of AED

technology. Aero-medical groups have

recommended placing AED’s on board

airplanes and the experiences of airlines

that already carry AED’s have been

positive. Up to 15 different Air

Transport Association members

participated in a 1-year in-flight medical

event data collection effort in

cooperation with the FAA. This effort

was in response to one of the provisions

of the Aviation Medical Assistance Act

of 1998. The data were collected for the

period July 1, 1998, through June 30,

1999. There were 188 death or threat-ofdeath incidents resulting in a total of

108 deaths. (It should be noted that 11

of these incidents occurred on the

ground.) AED’s were used a total of 17

times, 14 times to deliver at least one

shock on board an aircraft. From these

events, four passengers were reported as

having survived. Assuming the four

passengers survived due to the use of

AED’s, the AED survival rate per

hundred million passenger

enplanements is 0.7193. The survival

rate may have been different if AED’s

had been aboard all participating

carriers’ aircraft for the entire data

collection period. If the survival rate

during the test period had been higher,

then the projected number of lives saved

over the next 10 years would be higher.

However, since this number cannot be

established from the available data, the

FAA will use the conservative

projection.

Applying the survival rate to the

estimated 7.5819 billion enplaned

passengers over the next 10 years may

result in 55 passenger medical event

outcomes being changed by AED’s

during that period.

The FAA acknowledges the difficulty

of quantifying benefits with any

precision at this stage of the rulemaking.

The FAA also believes that there is

merit in continuing to collect data on inflight medical incidents. Therefore, the

FAA may propose in the future that data

be collected on all uses of the

emergency medical kits and AED’s by

the certificate holder or its agents. This

data would be used to further refine the

contents of and training for the use of

the medical kits and the AED’s. Data

would be collected directly from the

certificate holders in a manner

prescribed by the Administrator. The

FAA seeks comment on the need for

further data collection. The FAA may

also issue a supplementary notice to

elicit comments on a specific proposed

data collection.

Costs

The FAA has analyzed the expected

costs of this regulatory proposal for a

10-year period, 2000 through 2009. All

costs in this analysis are expressed in

1998 dollars.

The estimated industry costs over 10

years total $138.1 million, or $95.6

million discounted. These costs consist

of the initial cost to equip the aircraft,

for carriers who have not voluntarily

placed AED’s and emergency medical

kits aboard their aircraft; the cost of

equipping new aircraft that the industry

will add to the fleet over the next 10

years; the cost of maintaining the

equipment and replacing medications,

and the weight penalty cost of carrying

the additional equipment. In addition,

the carriers will incur the cost of

initially training flight attendants in the

proper usage of the AED’s and for

recurrent training. The cost of AED’s is

estimated at $26.7 million, ($20.2

million discounted); the cost of

upgrading the emergency medical kits at

$4.0 million, ($2.8 million discounted);

and additional fuel is estimated to cost

$4.4 million, ($3.0 million discounted).

The training of flight attendants is

estimated to cost $103.0 million, ($69.7

million discounted).

The flight attendants receiving the

training as a result of this proposal

would probably view this as enhancing

their job skills and could lead to efforts

to raise their wages based on this

perception. The FAA has no basis for

estimating this possible impact on

industry costs. Public comments are

invited; the FAA requests that all

comments be accompanied by clear and

detailed economic documentation.

Cost-Benefit Analysis

If the proposed rule becomes

effective, the FAA estimates that as

many as 55 passenger medical outcomes

could possibly be changed over the next

10 years. Based on the estimated cost of

$138.1 million and an estimated 55 lives

possibly saved, the rule is estimated to

cost $2.5 million per life saved.

Approximately $88 million of the

total cost will be borne by the air

carriers that have voluntarily placed the

AED’s and expanded emergency

medical kits aboard their aircraft

principally due to the cost of recurrent

training of flight attendants. The cost to

major carriers that currently do not

carry this equipment is estimated at $39

million and small carriers would incur

a cost of $11 million as a result of this

proposal.

The FAA invites public comments

and requests that all comments be

accompanied with clear and detailed

economic documentation.

33728 Federal Register / Vol. 65, No. 101 / Wednesday, May 24, 2000 / Proposed Rules

Initial Regulatory Flexibility

Determination

The Regulatory Flexibility Act of 1980

(RFA) establishes ‘‘as a principle of

regulatory issuance that agencies shall

endeavor, consistent with the objective

of the rule and of applicable statutes, to

fit regulatory and informational

requirements to the scale of the

business, organization, and government

jurisdictions subject to regulation.’’ To

achieve that principal, the Act requires

agencies to solicit and consider flexible

regulatory proposals and to explain the

rationale for their actions. The Act

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 proposed or final

rule will have a significant economic

impact on a substantial number of small

entities. If the determination is that it

will, the agency must prepare a

regulatory flexibility analysis (RFA) as

described in the Act.

However, if an agency determines that

a proposed or final rule is not expected

to have a significant economic impact

on a substantial number of small

entities, section 605 (b) of the 1980 act

provides that the head of the agency

may so certify and a RFA is not

required. The certification must include

a statement providing the factual basis

for this determination, and the

reasoning should be clear. The Small Business Administration

suggests that ‘‘small’’ represent the

impacted entities with 1,500 or fewer

employees. For this proposed rule, the

small entity group is considered to be

part 121 operators (Standard Industrial

Classification Code 4512) with 1,500 or

fewer employees. The FAA has

identified a total of 60 operators that

meet this definition.

To determine the impact of the

proposed rule on small part 121

operators, the FAA has estimated the

annualized cost impact on each of those

small entities potentially impacted by

the proposed rule. The proposed rule is

expected to impose an estimated cost of

$10.9 million on the 60 small entities

over the next 10 years. The annualized

cost per small operator is estimated at

$18,300. This amount represents less

than one-tenth of the annual cost

($265,300, in 1998 dollars) to small

operators that the FAA considers

economically significant in that it may

entail either an increase in airline ticket

fares or a requirement to create

operating cost efficiencies to preserve

the economic stability of impacted

airlines. None of the 60 part 121 small

entities would incur a substantial

economic impact in the form of higher

annual costs in excess of $265,300, as

the result of the proposed rule. Therefore, the FAA has determined

that this proposed rule would not have

a significant impact on a substantial

number of small entities. Accordingly,

pursuant to the Regulatory Flexibility

Act, 5 U.S.C. 605 (b), the Federal

Aviation Administration certifies that

this rule would not have a significant

economic impact on a substantial

number of small entities.

International Trade Impact Assessment

The provisions of this proposed rule

would have little or no impact on trade

for U.S. firms doing business in foreign

countries and foreign firms doing

business in the United States.

A number of foreign carriers carry

AED’s and enhanced emergency

medical kits on flights to and from the

United States. U.S. carriers that have

voluntarily upgraded their emergency

medical equipment account for a

majority of the U.S.-flag international

service.

Federalism Implications

The FAA has analyzed this proposed

rule under the principles and criteria of

Executive Order 13132, Federalism. It

has determined that this action will not

have a substantial direct effect on the

States, on the relationship between the

national Government and the States, or

on the distribution of power and

responsibilities among the various

levels of government. Therefore, the

FAA has determined that this final rule

does not have federalism implications.’’

Unfunded Mandates Reform Act

Title II of the Unfunded Mandates

Reform Act of 1995 2 U.S.C. (the Act),

codified in 2 U. S. C. 1501–1571,

requires each Federal agency, to the

extent permitted by law, to prepare a

written assessment of the effects of any

Federal mandate in a proposed or final

agency rule that may result in the

expenditure by State, local, and tribal

governments, in the aggregate, or by the

private sector, of $100 million or more

(adjusted annually for inflation) in any

one year. Section 204(a) of the Act, 2

U.S.C. 1534(a) requires the Federal

agency to develop an effective process

to permit timely input by elected

officers (or their designees) of State,

local and tribal governments on a

proposed ‘‘significant intergovernmental

mandate.’’ A ‘‘significant

intergovernmental mandate’’ under the

Act is any provision in a Federal agency

regulation that would impose an

enforceable duty upon State, local, and

tribal governments, in the aggregate of

$100 million (adjusted annually for

inflation) in any one year. Section 203

of the Act, 2 U.S.C. 1533, which

supplements section 204(a), provides

that before establishing any regulatory

requirements that might significantly or

uniquely affect small governments, the

agency shall have developed a plan that,

among other things, provides for notice

to potentially affected small

governments, if any, and for a

meaningful and timely opportunity to

provide input in the development of

regulatory proposals.

This proposed rule does not contain

a Federal intergovernmental or private

sector mandate that exceeds $100

million a year.

Environmental Analysis

FAA Order 1050.1D defines FAA

actions that may be categorically

excluded from preparation of a National

Environmental Policy Act (NEPA)

environmental assessment or

environmental impact statement. In

accordance with FAA Order 1050.1D,

appendix 4, paragraph 4(j), this

rulemaking action qualifies for a

categorical exclusion.

Energy Impact

The energy impact of the notice has

been assessed in accordance with the

Energy Policy and Conservation Act

(EPCA) P.L. 94–163, as amended (43

U.S.C 6362) and FAA Order 1053.1. It

has been determined that the notice is

not a major regulatory action under the

provisions of the EPCA.

List of Subjects

14 CFR Part 121

Air carriers, Aircraft, Airmen, Alcohol

abuse, Aviation safety, Charter flights,

Drug abuse, Drug testing, Reporting and

recordkeeping requirements, Safety,

Transportation.

14 CFR Part 135

Aircraft, Airmen, Aviation safety,

Reporting and recordkeeping

requirements.

The Proposed Amendment

In consideration of the foregoing, the

Federal Aviation Administration

proposes to amend parts 121 and 135 of

Title 14, Code of Federal Regulations

(14 CFR parts 121 and 135) as follows:

PART 121—OPERATING

REQUIREMENTS: DOMESTIC, FLAG,

AND SUPPLEMENTAL OPERATIONS

1. The authority citation for part 121

continues to read as follows:

Authority: 49 U.S.C. 106(g), 40113, 40119,

44101, 44701–44702, 44705, 44709–44711,

Federal Register / Vol. 65, No. 101 / Wednesday, May 24, 2000 / Proposed Rules 33729

44713, 44716–44717, 44722, 44901, 44903–

44904, 44912, 46105.

2. Amend § 121.303 by revising

paragraphs (b) and (d)(2) to read as

follows:

§ 121.303 Airplane instruments and

equipment.

* * * * *

(b) Instruments and equipment

required by §§ 121.305 through 121.359

and 121.803 must be approved and

installed in accordance with the

airworthiness requirements applicable

to them.

* * * * *

(d) * * *

(2) Instruments and equipment

specified in §§ 121.305 through 121.321,

121.359, 121.360, and 121.803 for all

operations, and the instruments and

equipment specified in §§ 121.323

through 121.351 for the kind of

operation indicated, wherever these

items are not already required by

paragraph (d)(1) of this section.

* * * * *

§ 121.309 [Amended]

3. Amend § 121.309 by removing and

reserving paragraph (d).

4. Amend § 121.323 by revising the

introductory text to read as follows:

§ 121.323 Instruments and equipment for

operations at night.

No person may operate an airplane at

night under this part unless it is

equipped with the following

instruments and equipment in addition

to those required by §§ 121.305 through

121.321 and 121.803:

* * * * *

5. Amend § 121.325 by revising the

introductory text to read as follows:

§ 121.325 Instruments and equipment for

operations under IFR or over-the-top.

No person may operate an airplane

under IFR or over-the-top conditions

under this part unless it is equipped

with the following instruments and

equipment, in addition to those required

by §§ 121.305 through 121.321 and

121.803:

* * * * *

6. Amend § 121.415 by revising

paragraph (a)(3) to read as follows:

§ 121.415 Crewmember and dispatcher

training requirements.

(a) * * *

(3) For crewmembers, emergency

training as specified in § § 121.417 and

121.805.

* * * * *

§ 121.417 [Amended]

7. Amend § 121.417 by removing and

reserving paragraphs (b)(2)(ii) and

(b)(3)(iv).

8. Amend § 121.427 by revising

paragraph (b)(2) to read as follows:

§ 121.427 Recurrent training.

* * * * *

(b) * * *

(2) Instruction as necessary in the

subjects required for initial ground

training by § § 121.415(a) and 121.805,

as appropriate, including emergency

training (not required for aircraft

dispatchers).

* * * * *

9. Amend part 121 by adding subpart

X to read as follows:

Sec.

Subpart X—Emergency Medical Equipment

and Training 121.801 Applicability.

121.803 Emergency medical equipment.

121.805 Crewmember training for in-flight

medical events.

Subpart X—Emergency Medical

Equipment and Training

§ 121.801 Applicability.

This subpart prescribes the emergency

medical equipment and training

requirements applicable to all certificate

holders operating passenger-carrying

airplanes under this part.

§ 121.803 Emergency medical equipment.

(a) No person may operate a

passenger-carrying airplane under this

part unless it is equipped with the

emergency medical equipment listed in

this section or unless authorized by the

Administrator.

(b) Each equipment item listed in this

section—

(1) Must be inspected regularly in

accordance with inspection periods

established in the operations

specifications to ensure its condition for

continued serviceability and immediate

readiness to perform its intended

emergency purposes;

(2) Must be readily accessible to the

crew and, with regard to equipment

located in the passenger compartment,

to passengers;

(3) Must be clearly identified and

clearly marked to indicate its method of

operation; and

(4) When carried in a compartment or

container, must be carried in a

compartment or container marked as to

contents and the compartment or

container, or the item itself, must be

marked as to date of last inspection.

(c) For treatment of injuries, medical

events, or minor accidents that might

occur during flight time each airplane

must have the following equipment that

meets the specifications and

requirements of appendix A of this part:

(1) Approved first-aid kits.

(2) In airplanes for which a flight

attendant is required, an approved

emergency medical kit, as modified

effective [36 months after the effective

date of the final rule.]

(3) In airplanes for which a flight

attendant is required and with a

maximum payload capacity of more

than 7,500 pounds, an approved

automated external defibrillator as of

[36 months after the effective date of the

final rule].

§ 121.805 Crewmember training for inflight medical events.

(a) Each training program must

provide the instruction set forth in this

section with respect to each airplane

type, model, and configuration, each

required crewmember, and each kind of

operation conducted, insofar as

appropriate for each crewmember and

the certificate holder.

(b) Training must provide the

following:

(1) Instruction in procedures for

responding to medical events including

coordination among crewmembers.

(2) Instruction in the location,

function, and operation of emergency

medical equipment.

(3) Instruction in the handling of

medical events involving passengers or

crewmembers to include familiarization

with the emergency medical kit, as

modified on [36 months after the

effective date of the final rule].

(4) For each flight attendant—

(i) Instruction in the proper use of

automated external defibrillators, in

addition to the programmed hours of

instruction required by § 121.421(c).

(ii) Instruction in cardiopulmonary

resuscitation, in addition to the

programmed hours of instruction

required by § 121.421(c).

(iii) Recurrent training in the proper

use of automated external defibrillators

and in cardiopulmonary resuscitation,

at least once every 24 months, in

addition to the instruction required by

§ 121.427(c).

10. Revise Appendix A to part 121 as

follows:

Appendix A to Part 121—First-aid Kits

and Emergency Medical Kits

Approved first-aid kits, at least one

approved emergency medical kit, and at least

one approved automated external

defibrillator required under § 121.803 of this

part must be readily accessible to the crew,

stored securely, and kept free from dust,

moisture, and damaging temperatures.

First-Aid Kits

1. The minimum number of first-aid kits

required is set forth in the following table:

33730 Federal Register / Vol. 65, No. 101 / Wednesday, May 24, 2000 / Proposed Rules

Number of passenger seats Number of

first-aid kits

0–50 .......................................... 1

51–150 ...................................... 2

151–250 .................................... 3

More than 250 .......................... 4

2. Except as provided in paragraph (3),

each approved first-aid kit must contain at

least the following appropriately maintained

contents in the specified quantities:

Contents Quality

Adhesive bandage compresses, 1-inch ...................... 16

Antiseptic swabs ....................... 20

Ammonia inhalants ................... 10

Bandage compresses, 4-inch ... 8

Triangular bandage compresses, 40-inch .................... 5

Arm splint, noninflatable ........... 1

Leg splint, noninflatable ............ 1

Roller bandage, 4-inch ............. 4

Adhesive tape, 1-inch standard

roll ......................................... 2

Contents Quality

Bandage scissors ..................... 1

3. Arm and leg splints which do not fit

within a first-aid kit may be stowed in a

readily accessible location that is as near as

practicable to the kit.

Emergency Medical Kits

1. At least one approved emergency

medical kit that must contain at least the

following appropriately maintained contents

in the specified quantities:

Contents Quantity

Sphygmomanometer .................................................................................................................................................................................. 1

Stethoscope ............................................................................................................................................................................................... 1

Airways, oropharyngeal (3 sizes): 1 pediatric, 1 small adult, 1 large adult .............................................................................................. 3

Self-inflating manual resuscitation device with 3 masks (1 pediatric, 1 small adult, 1 large adult) ......................................................... 1:3 masks

CPR mask (3 sizes), 1 pediatric, 1 small adult, 1 large adult 1 ................................................................................................................ 3

IV Admin Tubing w/2 Y connectors: 1 ........................................................................................................................................................ 1 set

Alcohol sponges 1 ............................................................................................................................................................................... 2

Adhesive tape, 1-inch standard roll adhesive 1 ......................................................................................................................................... 1

Tape scissors 1 ................................................................................................................................................................................... 1 pair

Tourniquet 1 ........................................................................................................................................................................................ 1

Saline solution, 500 cc 1 ............................................................................................................................................................................ 1

Protective nonpermeable gloves or equivalent ......................................................................................................................................... 1 pair

Needles (2–18 ga., 2–20 ga., 2–22 ga., or sizes necessary to administer required medications) .......................................................... 6

Syringes (1–5 cc, 2–10 cc, or sizes necessary to administer required medications ................................................................................ 4

Analgesic, non-narcotic, tablets,1 325 mg ................................................................................................................................................. 4

Antihistamine tablets,1 25 mg .................................................................................................................................................................... 4

Antihistamine injectable, 50 mg, (single dose ampule or equivalent ........................................................................................................ 2

Atropine, 0.5 mg, 5 cc (single dose ampule or equivalent) 1 .................................................................................................................... 2

Aspirin tablets, 325 mg 1 ............................................................................................................................................................................ 4

Bronchodilator, inhaled 1 (metered dose inhaler or equivalent) ................................................................................................................ 1

Dextrose, 50%/50 cc injectable, (single dose ampule or equivalent) ....................................................................................................... 1

Epinephrine 1:1000, 1 cc, injectable, (single dose ampule or equivalent) ............................................................................................... 2

Epinephrine 1:10,000, 2 cc, injectable, (single dose ampule or equivalent) ............................................................................................ 2

Lidocaine, 5 cc, 20 mg/ml, injectable (single dose ampule or equivalent) 1 ............................................................................................. 2

Nitroglycerin tablets, 0.4 mg ...................................................................................................................................................................... 10

Basic instructions for use of the drugs in the kit ....................................................................................................................................... 1

1 Required on and after [36 months after the effective date of the final rule.]

Automated External Defibrillators

At least one U.S. Food and Drug

Administration-approved automated external

defibrillator that must:

1. Be stored in the passenger cabin.

2. Meet FAA Technical Standard Order

requirements for power sources for electronic

devices used in aviation or be otherwise

approved by the Administrator.

3. Be maintained in accordance with the

manufacturer’s specifications.

PART 135—OPERATING

REQUIREMENTS: COMMUTER AND

ON-DEMAND OPERATIONS

11–12. The authority citation for part

135 continues to read as follows:

Authority: 49 U.S.C. 106(g), 44113, 44701–

44702, 44705, 44709, 44711–44713, 44715–

44717, 44722.

13. Amend § 135.177 by revising

paragraph (a)(1) to read as follows:

§ 135.177 Emergency equipment

requirements for aircraft having a

passenger seating configuration of more

than 19 passengers.

(a) * * *

(1) At least one approved first-aid kit

for treatment of injuries likely to occur

in flight or in a minor accident that

must:

(i) Be readily accessible to

crewmembers.

(ii) Be stored securely and kept free

from dust, moisture, and damaging

temperatures.

(iii) Contain at least the following

appropriately maintained contents in

the specified quantities:

Contents Quantity

Adhesive bandage compresses,

1-inch ...................................... 16

Antiseptic swabs ......................... 20

Ammonia inhalants ..................... 10

Contents Quantity

Bandage compresses, 4-inch ..... 8

Triangular bandage compresses,

40-inch .................................... 5

Arm splint, noninflatable ............. 1

Leg splint, noninflatable .............. 1

Roller bandage, 4-inch ............... 4

Adhesive tape, 1-inch standard

roll ........................................... 2

Bandage scissors ....................... 1

Protective nonpermeable gloves

or equivalent ........................... 11

1Pair.

* * * * *

Issued in Washington, D.C., on May 18,

2000.

L. Nicholas Lacey,

Director, Flight Standards Service.

[FR Doc. 00–12982 Filed 5–22–00; 8:45 am]

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