[Federal Register Volume 65, Number 101 (Wednesday, May 24, 2000)]
[Proposed Rules]
[Pages 33720-33730]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-12982]



[[Page 33719]]

-----------------------------------------------------------------------

Part V





Department of Transportation





-----------------------------------------------------------------------



Federal Aviation Administration



-----------------------------------------------------------------------



14 CFR Parts 121 and 135



Emergency Medical Equipment; Proposed Rule

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

[[Page 33720]]


-----------------------------------------------------------------------

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, passenger-carrying 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 
date-stamped 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 pre-existing 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.

[[Page 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 on-board 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.

[[Page 33722]]

     ``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 in-flight 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.
---------------------------------------------------------------------------

    \1\ The 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.
---------------------------------------------------------------------------

     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 non-employee 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.

[[Page 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.) Sixty-four 
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 
near-death 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

[[Page 33724]]

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 
passenger-carrying 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: Secs. 121.303, 
121.309, 121.323, 121.325, 121.415, 121.417, 121.427. A minor editorial 
amendment is proposed for part 135 under Sec. 135.177. These 
modifications are described below.

Section 121.303  Airplane Instruments and Equipment

    Paragraphs (b) and (d) of Sec. 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 Sec. 121.309, would be 
modified to include a reference to proposed Sec. 121.803.

Section 121.309  Emergency Equipment

    Paragraph (d) of Sec. 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 Sec. 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 Sec. 121.309. Under this proposal, the introductory 
paragraph would be modified to include a reference to the proposed 
Sec. 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 Sec. 121.309. Under this proposal, 
the introductory paragraph would be modified to include a reference to 
proposed Sec. 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 Sec. 121.417. Under this proposal, paragraph (a)(3) 
would be modified to reference emergency training specified in both 
Sec. 121.417 and proposed Sec. 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 Sec. 121.417 therefore would be removed and reserved.

Section 121.427   Recurrent Training

    Paragraph (b)(2) of Sec. 121.427 currently requires recurrent 
training instruction, as necessary, in the subjects required for 
initial ground training by Sec. 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 Sec. 121.805.

[[Page 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 Sec. 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 
Sec. 121.309 (b) regarding inspection, accessibility, and marking 
requirements for emergency equipment.
    Section 121.803 paragraphs (c)(1) and (2) would require each 
passenger-carrying airplane to have approved first-aid 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 Sec. 121.309.
    Paragraph (c)(3) of Sec. 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 Sec. 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 Sec. 121.417.
    Paragraph (b)(3) of Sec. 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 Sec. 121.417.

    Paragraph (b)(4) of Sec. 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 Sec. 121.805(b)(4) would be in addition to the programmed 
hours of training required for flight attendants under 
Sec. Sec. 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 
first-aid 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, non-narcotic 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.

[[Page 33726]]

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 Administration-approved 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 In-Flight 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

[[Page 33727]]

in the use of emergency and life-saving equipment required to be 
carried, such as . . ., first-aid kits.'' Existing Sec. 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-of-death 
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 in-flight 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.

[[Page 33728]]

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-for-profit 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,

[[Page 33729]]

44713, 44716-44717, 44722, 44901, 44903-44904, 44912, 46105.

    2. Amend Sec. 121.303 by revising paragraphs (b) and (d)(2) to read 
as follows:


Sec. 121.303  Airplane instruments and equipment.

* * * * *
    (b) Instruments and equipment required by Secs. 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 Secs. 121.305 through 
121.321, 121.359, 121.360, and 121.803 for all operations, and the 
instruments and equipment specified in Secs. 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.
* * * * *


Sec. 121.309  [Amended]

    3. Amend Sec. 121.309 by removing and reserving paragraph (d).
    4. Amend Sec. 121.323 by revising the introductory text to read as 
follows:


Sec. 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 Secs. 121.305 through 121.321 and 121.803:
* * * * *
    5. Amend Sec. 121.325 by revising the introductory text to read as 
follows:


Sec. 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 
Secs. 121.305 through 121.321 and 121.803:
* * * * *
    6. Amend Sec. 121.415 by revising paragraph (a)(3) to read as 
follows:


Sec. 121.415  Crewmember and dispatcher training requirements.

    (a) * * *
    (3) For crewmembers, emergency training as specified in 
Sec. Sec. 121.417 and 121.805.
* * * * *


Sec. 121.417  [Amended]

    7. Amend Sec. 121.417 by removing and reserving paragraphs 
(b)(2)(ii) and (b)(3)(iv).
    8. Amend Sec. 121.427 by revising paragraph (b)(2) to read as 
follows:


Sec. 121.427  Recurrent training.

* * * * *
    (b) * * *
    (2) Instruction as necessary in the subjects required for initial 
ground training by Sec. Sec. 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


Sec. 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.


Sec. 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].


Sec. 121.805  Crewmember training for in-flight 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 Sec. 121.421(c).
    (ii) Instruction in cardiopulmonary resuscitation, in addition to 
the programmed hours of instruction required by Sec. 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 
Sec. 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 Sec. 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:

[[Page 33730]]



------------------------------------------------------------------------
                                                              Number of
                 Number of passenger seats                    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
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   3
 small adult, 1 large adult.
Self-inflating manual resuscitation device with 3  1:3 masks
 masks (1 pediatric, 1 small adult, 1 large
 adult).
CPR mask (3 sizes), 1 pediatric, 1 small adult, 1  3
 large adult \1\.
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    6
 necessary to administer required medications).
Syringes (1-5 cc, 2-10 cc, or sizes necessary to   4
 administer required medications.
Analgesic, non-narcotic, tablets,\1\ 325 mg......  4
Antihistamine tablets,\1\ 25 mg..................  4
Antihistamine injectable, 50 mg, (single dose      2
 ampule or equivalent.
Atropine, 0.5 mg, 5 cc (single dose ampule or      2
 equivalent) \1\.
Aspirin tablets, 325 mg \1\......................  4
Bronchodilator, inhaled \1\ (metered dose inhaler  1
 or equivalent).
Dextrose, 50%/50 cc injectable, (single dose       1
 ampule or equivalent).
Epinephrine 1:1000, 1 cc, injectable, (single      2
 dose ampule or equivalent).
Epinephrine 1:10,000, 2 cc, injectable, (single    2
 dose ampule or equivalent).
Lidocaine, 5 cc, 20 mg/ml, injectable (single      2
 dose ampule or equivalent) \1\.
Nitroglycerin tablets, 0.4 mg....................  10
Basic instructions for use of the drugs in the     1
 kit.
------------------------------------------------------------------------
\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 Sec. 135.177 by revising paragraph (a)(1) to read as 
follows:


Sec. 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
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................        \1\1
------------------------------------------------------------------------
1 Pair.

* * * * *

    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]
BILLING CODE 4910-13-P