[Federal Register Volume 66, Number 71 (Thursday, April 12, 2001)]
[Rules and Regulations]
[Pages 19028-19046]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-8932]



[[Page 19027]]

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Part III





Department of Transportation





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Federal Aviation Administration



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14 CFR Parts 121 and 135



Emergency Medical Equipment; Final Rule

  Federal Register / Vol. 66, No. 71 / Thursday, April 12, 2001 / Rules 
and Regulations  

[[Page 19028]]


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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Parts 121 and 135

[Docket No. FAA-2000-7119; Amendment No. 121-280 and 135-78]
RIN 2120-AG89


Emergency Medical Equipment

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: This action responds to the Aviation Medical Assistance Act of 
1998 by requiring that air carrier operators carry automated external 
defibrillators on large, passenger-carrying aircraft and augment 
currently required emergency medical kits. It affects those air carrier 
operations for which at least one flight attendant is required and 
includes provisions designed to provide the option of treatment of 
serious medical events during flight time.

EFFECTIVE DATES: Effective May 12, 2004.

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:

Availability of Final Rules

    You can get an electronic copy using the Internet by taking the 
following steps:
    (1) Go to the search function of the Department of Transportation's 
electronic Docket Management System (DMS) Web page http://dms.dot.gov/search).
    (2) On the search page type in the last four digits of the Docket 
number shown at the beginning of this notice. Click on ``search.''
    (3) On the next page, which contains the Docket summary information 
for the Docket you selected, click on the final rule.
    You can also get an electronic copy using the Internet through 
FAA's web page at http://www.faa.gov/avr/armhome.htm. or the Federal 
Register's web page at http://www.access.gpo.gov/su_docs/aces/aces140.html.
    You can also get a copy 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. Make 
sure to identify the amendment number or docket number of this 
rulemaking.

Small Business Regulatory Enforcement Fairness Act

    The Small Business Regulatory Enforcement Fairness Act (SBREFA) of 
1996, requires the FAA to comply with small entity requests for 
information or advice about compliance with statutes and regulations 
within its jurisdiction. Therefore, any small entity that has a 
question regarding this document may contact their local FAA official, 
or the person listed under FOR FURTHER INFORMATION CONTACT. You can 
find out more about SBREFA on the Internet at our site, http://www.faa.gov/avr/arm/sbrefa.htm. For more information on SBREFA, e-mail 
us at [email protected].

Background

    On May 24, 2000, the Federal Aviation Administration (FAA) issued a 
notice (65 FR 33720) proposing that air carrier operators of large, 
passenger-carrying aircraft carry automated external defibrillators 
(AED's) and augment currently required emergency medical kits (EMK's). 
The FAA proposed to make that action applicable to those air carrier 
operations for which at least one flight attendant is required. The 
objectives of that action can be summarized as follows:
     To respond to the Aviation Medical Assistance Act (the 
Act), enacted April 24, 1998 [Pub. L. 105-170, 49 U.S.C. 44701], which 
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.
     To modify, as appropriate, the regulatory requirements for 
EMK's in light of advancements in medical technology and treatments, 
the increase in passenger enplanements, and the anticipated increase in 
the occurrence of inflight medical events.
     To require equipment that would provide crewmembers and 
passengers who might come forward to assist during an inflight medical 
event, more up-to-date treatment options, specifically AED's.
     To require flight attendant instruction in cardiopulmonary 
resuscitation (CPR) and AED usage.
     To require needed modifications to current minimum 
equipment and training standards without raising expectation among 
passengers or crewmembers about the ability to receive and/or provide 
in-flight emergency medical assistance.
     To establish a separate subpart under part 121 of Title 14 
of the Code of Federal Regulations (14 CFR part 121) that, while not 
deviating from established requirements for certain equipment and 
crewmember training, would provide greater regulatory flexibility in 
making future modifications that may be needed.
     To allow those affected air carriers that have not made 
emergency medical equipment modifications sufficient time to provide 
crewmember instruction and procure medical enhancements.

Comments Received

    The FAA received 370 comments on the proposal; 321 from the general 
public in support of the proposal, in particular, that AED's be carried 
on board passenger-carrying aircraft. Most of these 321 comments are 
from family, friends, co-workers, and acquaintances of a 28-year-old 
man who, they indicate, died on board an airliner in July 2000. These 
comments state that this passenger had been diagnosed with hypertrophic 
cardiomyopathy \1\ a few months prior to the flight and that, if an AED 
had been on board, it may have saved his life. These commenters express 
concern about the welfare of other passengers and state that they want 
to promote awareness about checking with an air carrier before booking 
a flight to assure the availability of an AED. This incident is of 
particular concern to the commenters given the young age and apparent 
sound physical condition of the passenger who died. The commenters 
state that he had been an accomplished athlete.
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    \1\ A primary myocardial disease of unknown cause that is 
characterized by a hypertrophied, nondilated, hypercontractile left 
ventricle. The annual mortality is 3-5%. The common mode of demise 
is sudden cardiac death. (Sudden cardiac death is defined as an 
unexpected, unpredictable cessation of effective contractions of the 
heart.) Therefore, the primary objectives of treatment are the 
amelioration of symptoms, the control of arrhythmias, and the 
prevention of sudden death. American Journal of Medical Science; 
Sept 1987: pp 191-210]
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    For the remaining comments, which are discussed in further detail 
below, 25 generally support the proposal but make detailed comments 
and/or request modifications; 22 express neither support nor opposition 
for the action but provide comments for consideration.
    The former (25) comments are from the following:

 Aerospace Medical Association (ASMA)
 Agilent Technologies (an AED manufacturer)
 Air Line Pilots' Association (ALPA)
 Air Transport Association (ATA)

[[Page 19029]]

 American Heart Association (AHA)
 America West
 Association of Professional Flight Attendants (APFA) 
(representing American Airlines' flight attendants)
 Complient (a national training center for the American Heart 
Association and the National Safety Council)
 Food Allergy Network
 Florida International University
 International Association of Firefighters
 International Association of Machinists and Aerospace Workers, 
AFL-CIO
 International Brotherhood of Teamsters Airline Division
 MedAire, an air carrier medical care provider
 Northwest Airlines
 Pakistan International Airways
 Teamsters Local 2000 (representing Northwest Airlines flight 
attendants)
 3 private citizens, 4 private physicians, and a volunteer 
firefighter

    The latter (22) comments are from private physicians, nurses, 
flight attendants, the Association of Flight Attendants (AFA), Atlantic 
Southeast Airlines, Continental Express (two separate comments), the 
Regional Airline Association (RAA), and the Small Business 
Administration.
    One commenter, identified as a Registered Nurse, is opposed to the 
proposal. She indicates, among her other comments, that ``if it is 
deemed necessary to be able to administer advanced medical care on any 
given flight, then turn this over to flight nurses and/or flight 
paramedics who are trained in all aspects of flight medicine/
pathophysiology/flight physiology.''
    The Civil Aviation Authority of the Hashemite Kingdom of Jordan 
states that it would like to implement the proposal for Jordan Air 
Lines.

Discussion of Comments

    Because the additional suggestions and requests for further 
modifications received from the various commenters are elaborate, for 
clarity of discussion the FAA categorizes them specifically as follows:

Automated External Defibrillators

Battery Requirements
    Agilent Technologies, an AED manufacturer, comments that the FAA 
should state the minimum requirements that AED's and their batteries 
must meet to be allowed in the aircraft environment and, in addition, 
reference the Flood and Drug Administration's (FDA) requirements for 
ensuring the safety and effectiveness of AED's. Agilent states that the 
reference in proposed part 121, appendix A to ``FDA-approved AED'' 
should be changed to ``AED legally marketed in the United States in 
accordance with FDA requirements.''
    Agilent requests that the FAA add further requirements to the 
regulation, specifically that paragraph 2. of the AED section of 
proposed part 121, Appendix A read as follows:

    2. Demonstrated through compliance with applicable sections of 
Technical Standard Order (TSO) requirements or other standards or 
testing to meet the following requirements:
    (a) The AED does not interfere with the safe operation of other 
aircraft equipment.
    (b) The AED and its power supply have safety features that 
prevent fire and explosion hazards.
    (c) The AED is designed such that the AED system does not create 
a hazard for occupants of the aircraft cabin.

    FAA response: The FAA agrees, and has verified with the FDA, that 
the reference to ``FDA-approved AED'' in the proposal should be changed 
to ``AED legally marketed in the United States in accordance with FDA 
requirements'' in the final rule.
    The FAA disagrees that further regulatory requirements for AED's 
are needed for this action. As with all equipment carried on board 
aircraft the certificate holder must ensure that AED's placed on 
aircraft do not interfere with safe operation of the aircraft.
    The FAA issued TSO-C142 on April 4, 2000. This TSO prescribes the 
minimum FAA performance standard that lithium cells and batteries must 
meet to be identified with the applicable TSO marking. The standards of 
this TSO apply to lithium cells and batteries intended to provide power 
for aircraft equipment including emergency and standby systems. The FAA 
intends that any AED powered by lithium batteries placed on an aircraft 
on or after April 4, 2000, would have to comply with this TSO.
    This requirement, in addition to being approved for aircraft use by 
the FDA, is adequate for the purposes of this action.
Servicing/Maintenance
    Complient, a national training center for the AHA and the National 
Safety Council, suggests that each AED should be serviced twice each 
year by a trained service specialist. Also, on-site service should be 
provided within 24 hours after each medical event to ensure that proper 
AED information and service requirements are met.
    FAA response: The FAA disagrees with the comment. As proposed and 
adopted, part 121, appendix A requires that AED's be maintained in 
accordance with the manufacturer's specifications. The FAA has 
determined that this is the best method to meet maintenance 
requirements.
Storage
    The ALPA recommends that AED's be stored in the cockpit. In its 
view, cockpit placement would assure that the flightcrew is well aware 
of the presence of an AED. Wtih the AED in the passenger cabin they 
state that flight attendants may become so focused on its use that the 
cockpit crew will not be notified about in-flight medical events. 
Further, the AED is a valuable piece of equipment and will be more 
secure in the cockpit.
    The AFA states that if AED's are required on aircraft, the devices 
should be in locations that are suitable for quick emergency response.
    FAA response: The FAA agrees that AED's should be stored in 
accessible locations as described under proposed part 121, appendix A.
    The FAA does not agree that the devices should be stored in 
cockpits. If stored in cockpits, the devices would be less accessible 
to flight attendants, crewmembers who will be required to have 
instruction in AED usage. Also, as cockpit crew always are to be 
notified about in-flight medical events as required under 
Sec. 121.417(b)(1), the FAA anticipated that cabin and cockpit crews 
will communicate during in-flight medical events.
    In addition, just prior to issuing the Notice of Proposed 
Rulemaking (NPRM), the FAA was made aware of four separate AED battery 
``rupturing'' incidents that had occurred on the ground, including one 
incident that occurred on a hangared jet. These ``rupturing'' incidents 
occurred in AED's powered by lithium sulfur dioxide batteries.
    The extremely energetic materials used in lithium cells, and in 
other AED power sources, are not intrinsically safe. Safety concerns 
include the possibility of fire, explosion, and the venting of toxic or 
flammable gases from any portable power source such as AED batteries. 
The FAA determined, therefore, that AED's would have to meet more rigid 
standards when carried on aircraft and would be more safely stored in 
the passenger cabin rather than the cockpit, more critical to safe 
flight operations.
Visual Inspection
    The ATA suggests that he FAA clarify that the inspection/marking 
requirement under proposed Sec. 121.803(b) does not apply to the visual 
inspection of emergency equipment typically

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performed by flight attendants at the start of each new crew shift.
    FAA response: The FAA agrees that the inspection/marking 
requirement under proposed Sec. 121.803(b) does not apply to visual 
inspection. However, as with all emergency equipment, AED's must be 
visually inspected by flight attendants as part of routine pre-flight 
procedures.

Data Collection

In-Flight Medical Events
    The ASMA observes that differences of opinion among the medical 
community exist because no comprehensive database describing in-flight 
medical events and deaths exists.
    The International Association of Machinists and Aerospace Workers, 
AFL-CIO, state that, to rely heavily on the data collection only, to 
support a rulemaking to provide AED's and related drugs on aircraft 
EMK's is ``woefully limited.'' Further, the FAA did not report from the 
data collection findings who used the AED's on passengers and whether 
any drugs were administered.
    The RAA states that the evaluation that was used to justify the 
proposal is not representative of the regional fleet since some 
regionals are only now equipping some or all in their fleets. Further, 
without a study that specifically addresses the effective use of AED's 
on regional flights, it questions whether AED's will be used at all.
    Contrary to these commenters, the ATA suggests that detailed 
reports on in-flight medical events is not needed and that the FAA 
should ``discard'' the idea of a supplemental information-gathering 
action. According to the ATA, it would be costly and burdensome, data 
submitted to the FAA likely will be subject to release under the 
Freedom of Information Act, and it will discourage emergency assistance 
from volunteer doctors and other health care providers.
    FAA response: The FAA does not believe that further studies are 
needed for this action at this time. As described in the NPRM, the FAA 
has conducted separate and specific studies on in-flight medical 
events. (Copies of these studies are on file in this docket.) Very 
limited assumptions can be made as a result of most of the studies 
conducted by the FAA (as well as outside organizations) on in-flight 
medical events and EMK usage for the following reasons: the long-term 
outcome of the passenger(s) beyond what occurs on the aircraft 
frequently cannot be determined; a passenger's past and subsequent 
medical history is a private matter and therefore generally 
unavailable. Thus it is typically difficult to assess why or even what 
medical event occurred.
    When it conducts studies, the FAA is obligated, under the Paperwork 
Reduction Act [5 CFR 1320.13], not to overburden entities from which it 
is collecting information. Therefore, the FAA typically does not 
collect data unless it is absolutely warranted, mandated, and/or 
invited. For this action, the Act directed that ``a major air carrier 
shall make a good faith effort to obtain, and shall submit quarterly 
reports on'' death or threat-of-death incidents occurring on board its 
flights. In the data collection that was conducted, up to 15 different 
air carriers, carrying approximately 85 percent of U.S. domestic 
airline passengers, contributed data throughout the year. As 
acknowledged in the NPRM, the data received had multiple limitations 
and appeared highly variable. Not all of the air carriers who supplied 
data were carrying AED's and/or enhanced EMK's; however, the intent of 
the study was, in part, to determine whether AED's (as well as other 
enhancements) would have been used had they been available. In that 
regard, out of a total of 188 events, an AED was reported as ``not 
available'' for 40 events in which they may have been used.
    The FAA was able to determine from this data collection that four 
passengers who were administered at least one AED shock during flight 
survived and continue to survive. In at least two of these incidents 
the event occurred right after takeoff. Subsequent to the data 
collection, further cases of long-term survival as a result of AED 
usage were revealed to the FAA, including cases involving crewmembers, 
some on short-haul flights. Because some events occurred right after 
takeoff and the flights were diverted back to the airport of departure, 
it is apparent that these events can occur regardless of the size of 
the aircraft or the length of the flight.
    Overall, 156 (of the total 188) events reported some type of 
medical assistance being provided on board the flight. The actual 
number might have been 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. 
Nitroglycerin and epinephrine were the medications most commonly 
reported as being used. Atropine and intravenous (IV) saline were used 
on time each.
    Because of conclusions that could be made from its most recent data 
collection and because the FAA anticipates an increase in in-flight 
medical emergencies for the future, the FAA has determined that this 
rule is needed now. The FAA will continue to study in-flight medical 
emergencies, to consider any recommendations, and to monitor the usage 
of the enhancements being made to the EMK's.

Emergency Medical Kits

EMK Containers; Location on the Aircraft; and Quantity Needed
    America West Airlines comments that, if the FAA intends to mandate 
that the modified EMK be contained in a single container or 
compartment, such a requirement should be specified in the rule. 
Similarly, the ATA indicates that, because the NPRM does not address 
containers for EMK's the final rule should clarify that soft-sided 
containers are acceptable. America West Airlines also states that the 
placement of the items should be left to air carrier discretion. 
Requiring a single container to include the current and new requirement 
would require air carriers to retrofit with larger-sized kits, 
triggering both material and labor expenses.
    Northwest Airlines suggests that language be included in the rule 
that would allow airlines to augment their existing EMK's with other 
additional specially designated medical kits without reference to any 
specific kit nomenclature. These additional kits would have as a 
minimum the additional EMK items called out in the NPRM. This 
modification would preclude the waste associated with making the 
existing EMK obsolete. It should also be noted that the additional 
items required under the NPRM will not fit into the existing EMK box 
found on Northwest Airlines aircraft.
    Pakistan International Airways would like to have the EMK divided 
into two types; one for the use of the cabin crew and a second for 
physicians travelling abroad.
    The RAA comments that regional airplanes do not have the space to 
accommodate a larger EMK and that it will be more costly to retrofit a 
regional airplane.
    FAA response: The FAA disagrees, in part, with these commenters. 
The proposal does not specify that the modified EMK be contained in a 
single container or in a hard, versus a soft, container. Therefore, 
this action does not require a retrofit and should not severely affect 
available storage space on an aircraft.
    The FAA modifies part 121, appendix A under this action to state 
``at least one'' EMK to accommodate certain air

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carriers who may use more than one container or more than one EMK. Some 
air carriers, for example, carry a so-called ``basic box'' to meet the 
minimum requirements and then also carry their own separate, modified 
EMK; some others may be carrying ``grab-and-go kits;'' and the like. 
Beyond what is set out in the regulation, the certificate holder may 
choose the number and type of kits desired as long as the basic, 
minimum EMK requirements are met.
    The FAA is aware that many air carriers contract with various 
medical kit providers and that these providers use various types of 
containerization, (e.g., soft-sided vinyl bags as well as rugged, 
double-walled, polyethylene cases.) The choice of which type of EMK, 
and whether more than one container may be used to meet the minimum 
requirements, is at the air carrier's discretion.
    As some air carriers may be using, or need to use, more than one 
container to meet the requirements the FAA adds the following paragraph 
under part 121, appendix A:

    3. If all of the above-listed items do not fit into one 
contained, more than one container may be used.

    It should be noted that formerly, under existing Sec. 121.309 
(b)(4) and to be adopted under Sec. 121.803 (b)(4), an FAA-required EMK 
container(s) must be marked as to contents and date of last inspection.
Expiration Date of EMK Medications
    America West Airlines suggests that procedures be established to 
preserve the shelf life of temperature-sensitive medications. Those 
such as lidocaine, if stored in a standard EMK, would require constant 
replacement thereby creating additional cost and administrative burden.
    FAA response: Currently required EMK medications as well as the 
following medications proposed for the EMK's have an expiration date of 
approximately 1 year: atropine, bronchodilator inhaler, dextrose, 
epinephrine, saline solution, and lidocaine; aspirin, non-narcotic 
analgesic, antihistamine, and nitroglycerin tablets.
    Under current experience (since 1986) with injectable 
antihistamine, dextrose, epinephrine, and nitroglycerin tablets, the 
FAA has not found expired medications to be a problem. Therefore, the 
FAA does not anticipate that medications will require constant 
replacement. If temperature extremes occur on the aircraft or if the 
medications have surpassed their expiration date; however, then the 
certificate holder should replace them. As has been the case since 
first required, EMK's must be inspected periodically according to 
schedules developed under operations specifications.
Medications
    The following is a list of additional equipment and medication that 
commenters suggest the FAA should include in EMK's:
Items Suggested:
    AED patient care kit containing a razor and towel
    Audio-prompting device
    Auto-injector to administer epinephrine
    Burn gel
    16 French Coude catheter
    Connecting tubing, IV Start kit, IV catheters 18g, 20g, 22g, 
Atropine 1mg, Epinephrine 1:10,000 1mg and Lidocaine 100 mg
    CPR masks fitted with an oxygen inlet and with a standard 15-22-mm 
connector available in one average size for adults with additional 
sizes for infants and children, equipped with a 1-way valve that 
diverts the victim's exhaled gas
    Dexamethasone
    EKG machine
    Endotracheal tube/laryngoscope
    Furosemide injection
    Glucometer
    Glucose gel-administered orally for symptoms of hypoglycemia
    Medication for seizure control
    Nasal cannulas in sizes appropriate for adult, child, and infant
    Pocket masks
    Portable oxygen equipment with regulator capable of delivering 
between 4 L/min and 12 L/min, including a hose capable of connecting to 
a resuscitation face mask, bag-valve mask, and a connecting system for 
use with a nasal cannula.
    A standardized portable response kit to include an AED, AED 
preparation kit, emergency oxygen, first-aid/BBP kits and supplies, and 
an audio prompt device.
A manual resuscitation bag-valve that has:
    A self-refilling bag
    A nonjam valve system allowing for a maximum oxygen inlet flow of 
30 L/min
    A non-pop-off valve
    Standard 15-/22-mm fittings
    A system for delivering high concentrations of oxygen through an 
ancillary oxygen reservoir
    A true nonrebreathing valve
    The capability to perform satisfactorily under all common 
environmental conditions and extremes of temperature
    Stretcher
    Torch lights w/spare batteries

    Eleven commenters stress the importance of air carriers carrying an 
epinephrine auto-injector. Although the FAA currently requires 
epinephrine, and proposes to require an additional quantity of it, the 
commenters indicate that an auto-injector is far easier and quicker to 
use and would be critical when attending to a passenger suffering from 
a severe allergic reaction in flight.
    FAA response: The FAA disagrees with these commenters. No 
commenters provided data (as requested in the NPRM) to confirm that 
these suggested additions for the EMK's would be necessary. Also, as 
noted in the NPRM, the purpose of the EMK's is to add some medical 
options; it is not comprehensive. The certificate holder may carry 
additional equipment/medications if deemed appropriate.
    Since 1986, all major, passenger-carrying air carriers have been 
required to carry epinephrine in on-board EMK's. Part 121, appendix A, 
requires two quantities of epinephrine (1:1000) in ``single dose ampule 
or equivalent.'' An additional preparation of epinephrine (1:10,000), a 
dose that may be used for heart stimulation, proposed under this action 
is intended to complement the dosage currently required, which is 
intended for use as a treatment for severe, or anaphylactic, allergic 
reactions.
    The FAA did not propose to require epinephrine auto-injectors 
because recent and former studies (on file in the docket) that the FAA 
has conducted on in-flight medical events did not reveal a need to make 
epinephrine auto-injectors available. These studies did suggest the 
need for an oral treatment for allergic reactions, therefore, an oral 
antihistamine was included in the NPRM.
    The FAA will review this matter in any future considerations of the 
EMK contents and for any subsequent regulatory action.
    The AHA cautions the FAA to be ``extremely conservative'' when 
considering EMK expansion. According to the AHA, the FAA should not 
approach expansion of the EMK's from the perspective of simply making 
available every drug and medical device ever requested by an in-flight 
physician. According to AHA, its international guidelines on CPR and 
emergency cardiovascular care have recommended far fewer resuscitation 
medications and medical devices than ever before.

[[Page 19032]]

Medications
    MedAire comments that consideration should be given to increasing 
the quantities of the proposed medications (in particular atropine, 
epinephrine, lidocaine) and that supplies needed to administer certain 
medications are not being required. For example, saline solution is 
included in the recommended kit contents, but no provisions have been 
made for an IV catheter, which is essential to administer the fluid. 
Also, specific syringe and needle sizes should be required.
    FAA response: The FAA disagrees with this comment. The FAA took a 
very conservative approach when assigning quantities to proposed 
medications given the limited need to use such medications in flight.
    In the preamble to the NPRM, it is clear that the FAA intends to 
require ``an IV administration kit'' which would include one or more IV 
catheters. In the regulatory language under proposed part 121, appendix 
A, that intent may have been misunderstood as the words ``1 set'' are 
used rather than ``kit.'' Therefore, for clarity, in the final rule, 
the FAA moves the word ``set'' from the ``Quantity'' column under 
proposed part 121, appendix A and places it after ``IV Admin'' so that 
the intent is clear.
    The FAA did include recommended, appropriate needle and syringe 
sizes in its proposal to part 121, appendix A. Further, the original 
language from 1986 (``or sizes necessary to administer required 
medications'') was maintained so that the FAA could remain as 
descriptive as possible.
    Another comment on medications, from the ATA, states that 
convenience medications, such as low-strength analgesics, should not be 
included in the kit. The kit should be intended for life-threatening 
emergencies only, and be opened only in the event of a true emergency 
by a ``responding health care provider'' or as directed by a 
``qualified health care provider.''
    FAA response: The FAA's study entitled ``The Evaluation of In-
Flight Medical Care Aboard Selected U.S. Air Carriers from 1996 to 
1997'' (on file in this Docket) reveals that certain convenience 
medications, such as an oral antihistamine, a non-narcotic analgesic, 
and a bronchodilator inhaler are appropriate for inclusion in air 
carrier EMK's. In its study, the FAA found these items to be necessary 
additions to the EMK because passengers, especially those with chronic 
allergies or asthma, do not always carry them or may inadvertently 
leave them in their checked baggage.
    Oral antihistamines may prove useful and necessary for attempting 
to assist a passenger experiencing severe allergy problems; a non-
narcotic analgesic, to relieve muscle aches and headaches; and a 
brochodilator inhaler, to attempt to restore normal breathing in an 
asthmatic passenger.
Periodic Review of Appropriate Content
    MedAire Inc., an air carrier medical care provider, requests that 
the FAA conduct a review of the EMK content every 2 years to ensure 
that required drugs continue to meet the AHA Advance Cardiac Life-
Saving guidelines. MedAire indicates that the FAA should establish a 
database in order to monitor kit usage and the appropriateness of its 
content.
    FAA response: The FAA concurs that EMK content must come under 
periodic review and the FAA will continue working in close 
collaboration with the public in that regard. However, the FAA did not 
propose to adopt the AHA Advance Cardiac Life-Saving guidelines and 
does not adopt that requirement now.
    It should be noted that the AHA, in its comment to the docket, 
cautions the FAA to be ``extremely conservative'' when considering 
expansion of in-flight EMK's. This is the approach that the FAA has 
adopted at this time. This final rule will establish a separate subpart 
under part 121 with a view to facilitating short-term issuance of any 
needed amendments in the future.
Protective Barrier Devices
    According the MedAire, the requirement for protective barrier 
devices (e.g., gloves, masks, etc.) can be simplified by allowing 
airlines the ability to use those that have been designed for universal 
application rather than having to house three different, specific sizes 
within the kit.
    For items such as airways, resuscitation devices, and CPR masks, 
the ATA indicates that, rather than specifying quantity and sizes, the 
final rule should simply require that the EMK contain those items 
suitable for all air travelers. This change would permit airlines to 
select, for example, a universal mask that could fit or be adapted to 
all travelers, including infants, children, and adults.
    The AFA believes that a face mask is more appropriate than a face 
shield. It is concerned that some of the air carriers have chosen to 
provide only a face shield. Without the FAA mandating the personal 
protective equipment required, some air carriers may choose to continue 
to provide this type of barrier device versus a face mask.
    The APFA requests that pocket masks be required and made more 
accessible. Without a mask, it indicates, flight attendants are 
potentially exposed to hepatitis, AIDS, and other diseases. The APFA 
recommends that ``grab-and-go parts of acronym-syndrome kits'' be made 
``no-go'' items or that each flight attendant be issued a mask and be 
required to carry it. Pocket masks also could be attached or made part 
of the ``defibrillator kit.''
    FAA response: The FAA is not opposed to affected air carriers 
carrying airways, CPR masks, and masks for use with self-inflating 
manual resuscitation devices designed for universal application, 
provided they are carried in quantities of three and provided they are 
appropriate for pediatric and small and large adult use. The devices 
must, however, be equivalent to those required under the regulation.
    The FAA did not propose that any equipment be used but rather that 
it be available for possible use if the certificate holder or its 
agents (e.g., flight attendants) so choose. Therefore, if different 
equipment, in addition to that required is desired then the certificate 
holder may provide it.
    With the addition of the words ``or equivalent'' after the 
requirements for airways, self-inflating resuscitation devices, and CPR 
masks under part 121, Appendix A, the final rule is adopted as 
proposed.
Quality of EMK's
    The Teamsters Local 2000, National Safety and Health Department, 
representing Northwest Airlines flight attendants, states that, in many 
cases, EMK's include cheap, disassembled parts, with medical equipment 
manufacturers taking advantage of the air carriers by placing sub-
standard equipment in the kits purchased by the air carriers. The 
applicable regulations specify contents of the EMK but do not make 
determinations about their quality. As referenced in the FAA report 
published in 1991, and based on a 2-year study of medical kit use, the 
poor technical quality of the most frequently used equipment was 
revealed. The commenter believes that this aspect of EMK's must be 
addressed.
    FAA response: The FAA disagrees that it requires or allows EMK's of 
poor technical quality. Part 121, appendix A as it currently exists and 
as it will be adopted requires an ``approved'' EMK that must contain 
``appropriately maintained contents.'' Not maintaining equipment or 
carrying sub-standard equipment, therefore, constitutes a violation of 
part 121. While the FAA does not endorse or recommend

[[Page 19033]]

equipment suppliers, it is expected that the certificate holders will 
procure equipment of appropriate quality.
    The available data from the 1991 FAA report entitled ``Response 
Capability During Civil Air Carrier In-flight Medical Emergencies'' 
(filed in this Docket) did not reveal overall poor technical quality of 
the EMK. Rather, it revealed one case in which an ``inopertative'' 
blood pressure cuff was criticized and fewer than five cases in which 
better airway equipment was recommended. The FAA believes that the 
quality of the equipment required by the regulations is maintained by 
routine FAA oversight of air carrier operations.
Usage of EMK's on Regional Air Carriers
    The RAA indicates that the proposed enhanced EMK's simply will not 
be used in a typical regional operation given the lack of opportunity 
and lack of medical guidance needed to use the materials.
    FAA response: The FAA disagrees that in-flight medical events will 
not occur during regional operations. Cardiac events can occur at any 
time, in any place, and to anyone. While professional medical guidance 
may not be as readily available or forthcoming on a regional flight, it 
is anticipated that certificate holders and its agents will act 
appropriately to provide for the safety of the passengers on the 
aircraft.
    Flight attendants receive instruction in passenger emergency 
medical care only to a level that would allow them to attempt care if 
appropriate and safe. Under this action, they will need to become 
familiar with the modifications being made to the EMK in the event that 
care is chosen to be provided or if any other passenger attempts to 
assist.
    It should be noted that crewmembers have been required, under 
existing Sec. 121.417(b)(3)(iv), to be familiar with what is contained 
in the EMK. This action does not change that requirement, except to 
move the provision under Sec. 121.805(b)(3) and to require 
familiarization with the EMK as modified.
    If serious medical events do occur in flight, having enhanced 
emergency medical equipment available may facilitate the ability to 
attempt to assist a passenger.

Flight Operations

EMK's/AED's as ``No-Go'' Items
    With the proposed additions to the medical equipment onboard 
aircraft and the increased cabin crewmember training, MedAire's 
experience indicates that airlines will be using their onboard medical 
equipment much more often. Therefore, MedAire comments that 
consideration should be given to the airlines allowing them to fly a 
passenger flight to a maintenance facility where the equipment/medical 
kit can be replaced rather than having them maintain expensive 
inventories at every destination. The high cost of this equipment and 
stocking requirements would make it difficult for the airlines to 
manage the program under a strict ``no-go'' rule. The possibility 
exists that a diversion into a non-station airport potentially could 
ground an aircraft and strand passengers.
    The ATA comments that the FAA needs to clarify the intent of the 
words ``unless authorized by the Administrator'' under Sec. 121.803 (a) 
that flights are not delayed or canceled unnecessarily. Specifically, 
air carriers should not be forced to seek authorization on a case-by-
case basis as the issue arises. The ATA recommends that an airplane 
should be permitted to operate in commercial service for a reasonable 
period of time (up to 5 days) while an AED is not available, such as 
for battery replacement or maintenance or, in the case of an EMK, 
required items are replenished. To achieve this, the FAA could allow 
conditional FAA Principal Operations Inspector (POI) authorization for 
such operations in advance through operations specifications, a Master 
Minimum Equipment List provision, or as past of approved AED 
maintenance plans.
    The APFA recommends that ``grab-and-go kits'' be made ``no-go'' 
items such that aircraft cannot depart without them unless each flight 
attendant is issued a mask and is required to carry it.
    FAA response: The FAA agrees, in part, with these comments. In 
particular, the ATA's comment that air carriers should not be forced to 
seek authorization on a case-by-case basis for flights without EMK's 
and/or AED's available.
    Under long-standing regulation, existing Sec. 121.309 (a), an 
airplane may not be operated unless it is equipped with required 
emergency equipment, including EMK's. Therefore, EMK's have always been 
considered ``no-go'' items and must be carried as listed by the Master 
Minimum Equipment List. ``Grab and go kits,'' as suggested by the APFA, 
are not an adequate substitute.
    Under Sec. 121.803 (a), as proposed, the FAA carried over the 
provisions of Sec. 121.309 (a) but added the words ``unless authorized 
by the Administrator.'' The intent of this proposal was to cover 
situations in which an AED may be inoperable or not available for 
flight; however, the FAA inadvertently extended that provision to all 
``emergency medical equipment'' which also would include EMK's. Upon 
further review, the FAA has determined that AED's should be, and EMK's 
should remain, ``no-go'' items.
    To allow an airplane without an EMK or AED to be operated in 
commercial service up to 5 days, as ATA suggests is not consistent with 
this action. Nor is it consistent to provide conditional POI 
authorization through operations specifications, a Master Minimum 
Equipment List, or as part of approved AED maintenance plans. 
Therefore, until the FAA develops more experience with the enhanced 
EMK's and AED's it will continue the current provision under 
Sec. 121.309 (a) and will adopt Sec. 121.803(a) without the words 
``unless authorized by the Administrator.''
Single Flight Attendant Requirement
    Continental Express suggests limiting the applicability of the 
proposal to flight operations requiring two, rather than one, flight 
attendant. Airplanes with as few as 10 passenger seats are required 
under Sec. 121.391 to have a flight attendant. Continental Express 
asserts that it is unreasonable to expect a single flight attendant to 
attend to a stricken passenger while simultaneously performing the 
duties associated with approach and landing.
    The International Brotherhood of Teamsters, Airline Division, wants 
the rule to explicitly address potential conflicts between existing 
regulations and the administration of CPR and/or the provision of any 
other first-air/responder care. It must also explicitly provide for 
resolution to these conflicts. While common sense may determine that 
the flight attendants continue with CPR, the regulations should address 
these circumstances. Air carriers and their employees should not have 
to be burdened with conflicting rules.
    The Teamsters Local 2000 (representing Northwest Airlines flight 
attendants) comments that, when medical emergencies occur, compliance 
with certain regulations pertinent to cabin crewmembers may become more 
challenging.
    The RAA indicates that the proposed rule fails to address the 
potential safety concerns in having one flight attendant devote time to 
attending to a medical event when this flight attendant has regulatory 
responsibilities and other passengers. On a regional airline there is 
the possibility that a flight attendant could accidentally shock him or 
herself. The suggested airborne medical emergency procedures will 
subject the flight attendant and other passengers to a greater risk of 
injury from airplane

[[Page 19034]]

movement particularly if a flight diversion occurs. In contrast to 
these commenters, MedAire believes that the recommendation to include 
aircraft with a single cabin crewmember as a part of the ruling is a 
sound one.
    According to MedAire, since a person must be defibrillated within 
10 minutes following cardiac arrest, it becomes impossible for any 
aircraft to reach life-saving medical attention in time. Today's single 
cabin crewmembers routinely are taught CPR during emergency training. 
Defibrillation has become a portion of the basic life support 
capability that is embodied within the CPR skill. Just as on any other 
aircraft, a flight attendant who is handling a medical emergency must 
redirect priorities if another emergency occurs that stands to impact 
the lives of others onboard.
    FAA response: The FAA disagrees that this action conflicts with 
existing regulations as there is no regulation that the certificate 
holder or its agents provide care.
    As noted previously, the FAA amended Sec. 121.309(d)(1)(ii) under 
the ``Commuter Rule'' to require an EMK in airplanes for which a flight 
attendant is required. This action transfers that provision to 
Sec. 121.803 and expands it to include an AED as well as an EMK. The 
FAA bases the determination to continue this requirement on the 5 years 
of experience it has had under the regulation and did not find a need 
to modify it.
    While not a routine occurrence, in-flight medical events, like 
other on-board events such as smoke or fire, do affect the ability of 
flight attendants to perform their duties. For this reason, unexpected 
scenarios, and how to respond to them while maintaining a safe, calm, 
and orderly passenger cabin environment, must be trained. But exactly 
how to deal with these events is at the discretion of the certificate 
holder and its agents.

Size/Seating Capacity of Aircraft Affected

    Continental Express indicates that the FAA has not factored 
airplane size or route length into its justification and that it 
appears that the size of aircraft affected was an arbitrary decision. 
The added weight, unit expense, and scarce cabin space may render the 
smaller (50 passengers and less) aircraft unlikely candidates for this 
rule. It suggests that the applicability of this rule, and others like 
it, be driven by passenger seat capacity (a fixed value) versus a 
variable weight. Further, Continental Express asserts that the 
probability a passenger suffering a medical event while on board a 
small airplane operating a short flight segment is much lower than the 
probability of a passenger suffering a medical event on a large 
airplane, operating a long flight segment.
    FAA response: The size of the aircraft affected under this action 
was constrained in part by the direction set forth in the Act as 
follows:

    ``(d) Limitation.--The Administrator may not require automatic 
external defibrillators on helicopters and on aircraft with a 
maximum payload capacity (as defined in section 119.3 of title 14, 
Code of Federal Regulations) of 7,500 pounds or less.''

Although there are variables in payload capacity and size of aircraft, 
the more than 7,500 pound payload capacity roughly translates to 
aircraft with a capacity for 30 passengers.
    In 1995, the FAA required one flight attendant as part of the 
``Commuter Rule'' [60 FR 65832; December 20, 1995] for this size 
aircraft. This rule also required an EMK. Based on its experience, the 
FAA has determined that this size aircraft is the size necessary for 
EMK's and AED's.
    The FAA has no data to indicate that the probability of a passenger 
experiencing an in-flight medical event is lower on a small airplane 
operating a short-flight segment. The FAA has determined that all 
passengers should be treated equally by having, to the extent possible, 
the same options for in-flight medical treatment.

Good Samaritan Protection

    Seven commenters raise the issue of the applicability of the ``Good 
Samaritan'' provision.
    A flight attendant indicates that flight attendants need legal 
protection under a ``Good Samaritan law'' that would provide them tort 
immunity (except in the case of gross negligence). If this is not the 
case, this flight attendant points out that he may not respond as 
quickly or aggressively as he might otherwise out of fear of being 
sued.
    The AFA and the Trinity Medical Network, a global emergency medical 
evacuation company based in Singapore, propose that letters of 
indemnification be given to flight attendants to protect them from 
liability.
    The International Association of Machinists and Aerospace Workers, 
AFL-CIO, appreciates the fact that the Act includes a ``Good 
Samaritan'' provision that limits air carriers' liability when 
obtaining medically qualified non-employee passengers to assist persons 
but questions whether this same protection applies to flight 
attendants.
    The ALPA recommends that the ``Good Samaritan'' provisions be 
clearly stated in the rule itself and should be a specific required 
training subject. Knowledge of the ``Good Samaritan'' protection could 
positively influence the willingness of a medical professional to step 
forward to assist in an in-flight medical emergency.
    The International Brotherhood of Teamsters, Airline Division, 
observes that the NPRM only briefly touches on legal liability issues 
in its background discussion section. Legal liability issues may arise 
out of these new requirements and expectations. This liability must not 
be placed on the shoulders of the flight attendant or flight deck 
crewmember. Crewmembers must be indemnified. At the very least, air 
carriers must be required to provide indemnification for their 
employees who respond in accordance with air carrier policies and 
procedures.
    Teamsters Local 2000 (representing Northwest Airlines flight 
attendants), reveals that the legal immunity afforded flight attendants 
in the use of emergency medical equipment presents a concern. The legal 
protection afforded flight attendants must be clearly defined and made 
a part of the proposed regulations applicable to crewmember actions in 
support of a medical emergency, whether on or off the aircraft (as in 
the jetway for example).
    FAA response: The FAA disagrees with these commenters. As stated 
before, there is no requirement that certificate holders or their 
agents provide medical assistance to passengers. If the certificate 
holder or its agents voluntarily choose to provide care, the provisions 
of the Act will apply. The ``Good Samaritan'' provisions of the Act do 
not require further implementation by the FAA. The issues raised by the 
commenters are between employees and employers and as such are not 
subject to this rulemaking.

Quality Control

    Complient suggests that reference to data management criteria 
should be provided in the final regulation. It suggests a program to 
track and report the details of every in-flight medical event via the 
Internet. This process would ensure compliance and allow immediate 
access to all quality assurance information.
    The AHA concludes that the FAA should implement strong quality 
improvement components by establishing close medical review of all uses 
of an AED during commercial air travel. This review should include both 
appropriate, and perhaps not so appropriate, use of the AED.

[[Page 19035]]

    The ASMA and America West Airlines suggest a standardized review 
program that would provide an efficient and expeditious process for 
monitoring the use and effectiveness of the equipment and medicines and 
aid in determining the need for possible future modifications to the 
kits.
    Complient recommends that the FAA review new technologies that 
support the mission and implementation of the ``AED program.''
    A private citizen, who does not identify affiliation, observes that 
the distribution of technology does not ensure its proper use. A 
significant portion of the plan for this distribution should be focused 
on proper training for flight attendants and education for the airborne 
public.
    FAA response: The FAA disagrees with these comments. As discussed 
in the NPRM preamble, while the FAA believes that this action is 
needed, it is also aware that adding enhancements could be 
misinterpreted. The FAA is not establishing a proposal for in-flight 
medical care. Passenger expectations regarding the level of medical 
care should not unrealistically raised by this action. In-flight 
medical assistance will continue to be discretionary to the certificate 
holder and its agents. In-flight medical care voluntarily provided must 
be regarded as limited emergency treatment with no unrealistic 
expectations of favorable outcomes for passengers having medical events 
in flight.
    While it is not within the purview of the FAA to mandate or 
regulate health care, the FAA can require that certain equipment be 
available. When equipment is carried on the aircraft, the FAA requires 
that airline personnel must be familiar with where it is located and 
how it is used. Making the equipment available and having airline 
personnel recognize where it is located and how it is used, if so 
desired, is the basic intent of this action.
    The FAA has long-standing procedures and personnel in place to 
assure that all equipment carried on board an aircraft are maintained 
and stored properly. The FAA continues this by including AED safety 
standards, initial training requirements for crewmembers, and recurrent 
training provisions for flight attendants.

Training

Annual vs. Biennial Recurrent Training Hours Needed
    MedAire recommends that the FAA adopt, at the very least, an annual 
recurrent training requirement, which would tie into the flight 
attendants' annual training program.
    The AFA states that, until an air carrier adopts the concept of 
performance-based standards, the training schedule for AED and CPR 
should be conducted every 12 months. It is imperative that the FAA 
follow the guidelines set by the American Red Cross and the AHA. These 
guidelines best represent the knowledge of training in these areas and 
set the minimum recurrent standards that these two organizations have 
set. According to the AFA, the last training outline that it received 
from these organizations revealed that a training certificate was valid 
for 1-year intervals. Therefore, the FAA should follow that guidance.
    The International Brotherhood of Teamsters, Airline Division, 
concurs that the regulation should require recurrent training annually 
rather than every 24 months.
    According to the International Association of Machinists and 
Aerospace Workers, AFL-CIO, non-medical professionals, such as police 
officers and fire fighters most likely are faced with having to use an 
AED than are flight attendants and have assistance more readily 
available. The huge majority of flight attendants probably will never 
face such situations or maybe once in their careers. Receiving 
appropriate training every 2 years when they may never have encountered 
a real-life situation does not ensure the confidence level that the 
rule is assuming.
    FAA response: While the FAA recognizes that annual performance 
drills would be preferable and applauds those air carriers that conduct 
the drills at 1-year intervals, under existing Sec. 121.417 similar 
recurrent training is conducted on a 24-month basis. The FAA did not 
want to deviate from existing practice by establishing a separate 
training schedule.
Blood-Borne Pathogens/Occupational Safety and Health Administration 
(OSHA)
    The International Association of Machinists and Aerospace Workers, 
AFL-CIO, comments that blood-borne pathogens have not been addressed in 
the NPRM and that it must be addressed in conjunction with the IV kits. 
At the least, the training aspect of dealing with blood-borne pathogens 
must be included in this rule.
    The International Brotherhood of Teamsters, Airline Division, 
remarks that the proposed rule does not address occupational safety and 
health risks for flight attendants who potentially may be exposed to 
blood-borne pathogens in the performance of their duties. Further, it 
does not require enforcement of the OSHA Bloodborne Pathogen Standard 
to safeguard against those risks. This standard, and a requirement for 
compliance by air carriers, must be incorporated by reference into the 
final rule. Such action would demonstrate the FAA's intent to act on 
the Memorandum of Understanding recently signed with OSHA.
    Teamsters Local 2000 (representing Northwest Airlines flight 
attendants), comments that flight attendants must have both the 
training and personal protection to take on ``first responder'' 
responsibilities. Such training must include blood-borne pathogens, 
with the current OSHA Bloodborne Pathogen Standard applied to Flight 
Attendants to safeguard against the known risks involved. It would be 
irresponsible to require AED training and not include CPR and blood-
borne pathogen training as well.
    According to the AFA, it is anticipated that the OSHA standard on 
blood-borne pathogens will be one of several OSHA standards that will 
be proposed as OSHA rules covering flight attendants after an initial 
OSHA/FAA team report is completed by December 6, 2000. If the air 
carriers are going to be doing training on CPR and in AED usage, OSHA 
promulgation of its blood-borne pathogen standard covering flight 
attendants should be coordinated to take effect on the same date as 
this FAA final rule. This will ascertain that the air carriers have an 
obligation to provide training on occupational exposure to blood-borne 
pathogens and other potentially infectious materials, in addition to 
other protections provided by the standard.
    Complient comments that, if employees are trained and designated as 
responsible for rendering first-aid or medical assistance as part of 
their job duties, they are covered by the protections of the OSHA 
standard. It is an OSHA violation if employees who administer first-aid 
as a collateral duty are not offered a hepatitis B vaccine. It also 
comments that a program of blood-borne pathogen training mandated 
annually would provide impetus to conduct at least an annual review of 
AED-CPR procedures.
    FAA response: Because of the FAA's ongoing review \2\ of blood-
borne pathogens, among other issues, with OSHA, this action does not 
include a regulatory reference to blood-borne

[[Page 19036]]

pathogens. The FAA continues to promote awareness of blood-borne 
pathogen exposure through guidance material found under Advisory 
Circular 120-44; March 9, 1995.
---------------------------------------------------------------------------

    \2\ See the First Report of the FAA/OSHA Aviation Safety and 
Health Team, dated December 2000, entitled, ``Application of OSHA's 
Requirements to Employees on Aircraft in Operation'' on file in this 
docket.
---------------------------------------------------------------------------

Guidance Material for FAA Inspectors
    The AFA is in favor of FAA inspectors being provided with criteria 
to use when approving the training associated with this rule. If the 
FAA intends to provide criteria or guidance through another means such 
as an Advisory Circular or Handbook Bulletin, this should be stated in 
the preamble. These criteria should be made available for public 
comment before they are published, within 6 months following the 
issuance of the final rule.
    FAA response: The FAA developed a Flight Standards Information 
Bulletin for Airworthiness, FSAW 98-05, that provides POI's with 
information regarding installation and use of medical portable 
electronic devices abroad aircraft. Specifically, it familiarizes and 
standardizes the carriage, testing, and operational use of AED's aboard 
aircraft, and provides policy and guidance concerning this issue.
    Typically, the FAA does not issue Advisory Circulars until adoption 
of a final rule. Whatever guidance the FAA issues as a result of this 
action will be published in the Federal Register for public comment.
On-Line Training Programs
    Complient mentions an on-line training program as a means of 
ensuring that all flight attendants are properly trained and of 
containing initial and recurrent training costs.
    FAA response: Flight Standards Handbook Bulletin for Air 
Transportation, HBAT 98-09, clarifies and presents guidance for POI's 
in responding to operators' requests to substitute home study training 
modules for approved traditional classroom training modules. The FAA 
POI must ensure that the course of study will effectively duplicate the 
classroom training to be replaced. No substitutions are considered for 
any flight training, Basic Indoctrination, Initial, Transition, or 
Upgrade training. Requests for substitutions to Recurrent, 
Requalification, or Refresher training are considered. Only cognitive 
or knowledge-based training is eligible for consideration for home 
study. Hands-on AED or CPR training would not be possible.
Standardization
    The AHA recommends standardizing the ``in-flight'' defibrillation 
course'' to a nationally recognized CPR-AED curriculum, such as the 
Heartsaver AED course of the AHA, the National Safety Council, or the 
American Red Cross. A training curriculum is needed that integrates 
both CPR and the use of the AED into a single integrated course. 
Further, customize the course for the specialized clinical environment 
of in-flight commercial aircraft. It indicates that it has assisted 
organizations, such as the recreational ski industry and the cruise-
ship industry, with industry-specific protocols.
    According to the AFA, using organizations such as the American Red 
Cross and the AHA will give the flying public assurance that training 
is being performed to a well-recognized worldwide standard. According 
to the AFA, the FAA has a responsibility to set minimum standards and 
can do so by looking to the guidelines provided by the national 
organizations. The minimum guidelines that these national organizations 
set should be the same minimum that the FAA requires.
    The AFA supports the concept of ``performance-based training'' 
rather than specified minimum training hours. The AFA believes that 
this approach would mirror the concepts listed in AC 120-54, Advanced 
Qualification Program. Each flight attendant should receive a 
Certificate of Proficiency upon successfully completing the training, 
prior to undertaking in-flight medical event duties. This certification 
will enhance the confidence of the flight attendant to perform life-
saving tasks.
    The International Brotherhood of Teamsters, Airline Division, 
states that the level of flight attendant training varies greatly from 
carrier to carrier. In many instances, flight attendants are not 
sufficiently trained for the first-aid/first response duties already 
assigned to them. Upgrading the equipment on aircraft without 
simultaneously upgrading the training requirements for flight 
attendants will only exacerbate this problem. At the very least, air 
carriers should be required to train flight attendants to a standard 
equivalent to that received by other ``flight responders.'' The 
standard must be specified in the regulation, not left to the 
discretion of the air carriers.
    Teamsters Local 2000 (representing Northwest Airlines flight 
attendants), would like to see comprehensive first-aid training 
requirements, increased programmed hours of instruction/frequency for 
CPR, and proficiency requirements.
    The ATA concurs with the FAA proposal not to require a specific 
number of hours of training.
    According to the ATA, the final rule should clarify, however, that 
the result of the training is not to ``certify'' the trainee. It should 
be explained that the purpose of the training is to ensure that the 
trainee has satisfactorily completed the training course. Using terms 
such as ``certify'' creates an expectation, if not a legal standard.
    According to the ATA, it is extremely important for the text of the 
final rule, not just the preamble, to state expressly that it is not 
the intention of the FAA to convert flight attendants or flightcrew 
into emergency medical personnel. Therefore proposed Sec. 121.801 
should have a new paragraph added to read as follows:

    Nothing in this subpart is intended to require crewmembers to 
provide emergency medical care or to establish a standard of care 
for the provision of emergency medical care by crewmembers or air 
carriers covered by this subpart.

    Further a new Sec. 121.805 (c) should be added to clarify that the 
required training is not intended to achieve a level of proficiency 
required of emergency medical personnel as follows:

    (c) The training required by this section is not intended to 
achieve the level of proficiency required to be attained by trained 
emergency medical personnel.

    Other comments received from individual commenters on the issue of 
standardization included the following: Medical training for flight 
attendants should be standardized and regulated; the minimal training 
that needs to be done is a certified paramedic training program; 
involve the Association of Air Medical Services, the Emergency Nurses 
Association, and the National Association of Paramedics; staff the 
cabin crew with several members certified in basic life support; and 
include at least two passenger cabin personnel who are certified in 
first-aid and CPR.
    FAA response: Given that almost every major air carrier voluntarily 
has implemented some form of acceptable and approved training program 
for flight attendants on the proposed modified EMK's, including AED's, 
the FAA did not propose to standardize ``one-size-fits-all'' 
requirements. The FAA believes that a specific, recommended course of 
standardized training would be overly burdensome. It does recommend, 
however, that instruction conform to national programs including those 
offered by the AHA or the American Red Cross. But as the provision of 
care is up to the certificate holder, it is up to the certificate 
holder to decide what program best fits its needs.

[[Page 19037]]

    Requiring flight attendants to be certified as first responders 
would put more responsibility on them, which is not the intent of this 
action. While in some cases, flight attendants may be the first and 
only responders to an in-flight medical event, it is up to the 
certificate holder to decide what, if any, care will be provided. 
Requiring first responder certification would be inconsistent with this 
action.
    Hands-on drills for medical emergencies are useful to have as an 
option for care. But, like other events for which training and drilling 
occur (e.g., fire) no certificate is provided.
    The FAA concurs that the ATA's recommended amendments to 
Secs. 121.801 and 121.805 would serve to clarify the intent of this 
action and adopts them, with minor modifications, under the final rule.
Suggested Training for Pilots
    Pakistan International Airways believes that cockpit and cabin crew 
should be able to institute IV fluids. All cockpit/cabin crew should 
acquire basic training in CPR and basic life support.
    The ALPA supports having flightcrew members being given initial 
training in the AED to include instruction in its proper use. While the 
flight attendants generally are the crewmembers who will use the AED, 
it also would be beneficial for pilots to be given such training.
    FAA response: Although the FAA does not require it, air carriers 
are not precluded from providing more extensive training to any 
crewmembers, including pilots. The FAA did not require pilot training 
on the AED's because it could not foresee, except under rare 
circumstance,s that the equipment would be used by pilots during 
flight.

Other Comments Received

    The following are additional comments received that, because they 
did not apply within the categories discussed above, are rendered here 
below categorized as ``OTHER COMMENTS RECEIVED.''

Airports

    The AHA, the ATA, and a private citizen request that this proposal 
be extended to include airport action.
    The AHA indicates that the airport programs already implemented 
have reported a remarkable level of early success. It urges the FAA to 
consider the successes of these current airport public access to 
defibrillation programs and reconsider its decision not to act to 
advance these successes in other airports.
    The ATA states that the NPRM ``does not deal'' with the issue of 
whether airports should ``install'' AED's and EMK's. Experience 
demonstrates that passengers do have medical emergencies in airports 
for which the availability of AED's and EMK's could be beneficial. The 
ATA urges the FAA to initiate rulemaking to address this need.
    FAA response: The FAA addressed airport medical events under 
separate action pursuant to the Act. As indicated in its June 6, 2000, 
Notice of Decision [65 FR 35971], the FAA determined that it would not 
require the same kind of enhancements at airports.
    The FAA conducted a survey and found that most airports are already 
well-equipped and have well-trained personnel available to respond to 
airport medical events. Data on 130 airports indicate that 108, or 83 
percent, have defibrillators, and that 11 airports, or 8.5 percent, 
have an off-airport response rate of less than 6 minutes. Thus, 119 
airports, or 91.5 percent, have the medical capability to address 
medical events including those in which AED's may be of assistance.
    In light of the determinations, of the widespread availability of 
emergency medical care, including AED's, at or near airports, the FAA 
decided not to propose action at airports.

First-Aid Kits

    The ATA requests that ammonia inhalants be deleted form the first-
aid kit content as they are an ``archaic modality.'' Attempting to 
administer ammonia inhalants to a passenger in Sudden Cardiac Arrest 
would waste valuable time. ATA also comments that the requirement to 
carry up to four first-aid kits is excessive because multiple uses of 
first-aid kits on a single flight are rare. Therefore, only one first-
aid kit per airplane should be required.
    FAA response: The focus of this action is on EMK's and not first-
aid kits. The FAA does not address first-aid kits in this action except 
to delete an outdated, obsolete (and therefore meaningless) reference 
to a Defense Department specification. The commenter's suggestions 
regarding first-aid kits cannot be considered because the FAA does not 
have data that would warrant removing the requirement to carry ammonia 
inhalants and/or reducing the number of first-aid kits required to be 
carried.

Ground-Based Medical Advisory Providers

    The RAA and MedAire mention the need to have a ground-based medical 
advisory provider. MedAire indicates that this service can be a 
valuable resource in helping to reduce medical-related diversions. The 
RAA indicates that several regional air carriers use these services 
but, in every instance, the flightcrew makes the call and not the 
flight attendants since air-to-ground phones are not available in the 
passenger cabin on regional airplanes.
    FAA response: As noted before, certificate holders can add 
equipment, including communication links, if they deem the equipment 
necessary. The FAA did not propose nor will it require this equipment 
as it is up to the certificate holder to provide whatever care the 
certificate holder deems appropriate.

New Subpart X Unnecessary

    Continental Express comments that, by removing the existing 
requirement in part 121, subpart K for EMK's (effective now) and 
putting it into new subpart X (effective in 3 years), the EMK 
requirement is inadvertently deleted in the interim. Continental 
Express finds that creation of a new Subpart X is unnecessary and 
cumbersome and that if the FAA intends to establish a separate subpart 
for emergency medical equipment only, it also should establish separate 
subparts for fire extinguishers, flotation equipment, crash axes, and 
megaphones. It suggests incorporating changes to emergency medical 
equipment requirements into existing subpart K and changes to 
crewmember training into existing subpart N. Otherwise, it can be 
construed that the air carriers will be required to provide identical 
training to crewmembers under two separate training programs. Also, 
removing the requirement in existing subpart K for training in ``other 
abnormal situations'' removes training requirements for addressing 
situations such as abusive passengers, intoxicated passengers, 
passengers who might jeopardize safety, turbulence encounters, and crew 
coordination.
    FAA response: The requirement to carry an EMK is not deleted in 
this action. Section 121.803 (c)(2) as added under new subpart X, will 
continue to require an approved EMK; however, air carriers will have 36 
months to modify their existing EMK's to meet the new standard. But, as 
the rule language could be misread, the FAA adds new paragraph (b)(4) 
under Sec. 121.805 and a new paragraph 2. under part 121, appendix A 
``Emergency Medical Kits'' to be more explicit.
    The requirement for training to accommodate ``other abnormal 
situations'' is not deleted; it continues to be found under existing 
Sec. 121.421(a)(1)(ii).

[[Page 19038]]

    It is not the intent of the FAA to create a need for two separate 
training programs to comply with the crewmember training requirements 
outlines in Sec. 121.805. It is the intent of the FAA that these 
training requirements will be incorporated into each air carriers' 
approved training program.
    The FAA developed a new subpart X for several reasons. Currently 
provisions for emergency medical equipment are dispersed throughout 
subparts N and O and, in the course of developing this action, the FAA 
determined that it would be more appropriate to incorporate emergency 
medical equipment requirements into one subpart. Because existing part 
121 sets forth specifications for emergency medical equipment under one 
separate appendix (part 121, appendix A), the FAA determined that 
regulatory provisions corresponding to these specifications would be 
more easily understood set forth under one separate subpart.

Noticing Intent of the Regulation in Airports and in Ticket Jackets

    The International Brotherhood of Teamsters, Airline Division, 
states that, to provide clear notice to the public of the intent of the 
regulation, notice should be posted in airports and in ticket jackets 
much the same as is required of security and hazardous materials 
information.
    FAA response: The FAA disagrees that signage requirements at 
airports and notification in passenger ticket jackets is necessary. As 
the intent of this action is to provide the certificate holder and its 
agents the option of providing in-flight medical assistance, there is 
no reason to alert the public by sinage that limited in-flight medical 
assistance may be available from the certificate holder.
    The FAA has always encouraged the public to seek qualified medical 
advice before travelling regarding any medical concerns.

Other Suggested Proposals for This Action

    Certain commenters request that the FAA do the following:
     Staff flights with medical personnel ready to respond to 
medical events.
     Limit alcoholic beverages consumed on flights.
     Establish a coordinated training program for crewmembers 
that would link them to ground EMS.
     Establish one centralized school for training flight 
attendants.
     Have passengers inform air carriers about particular 
physical status and/or special dietary needs.
     Deny air passage to pregnant women.
     Maintain oxygen with a flow regulator in a container 
adequate for at least 4 hours on overwater flights.
     Require two separate blood-borne pathogen kits (a response 
kit and a cleanup kit) containing several items.
    FAA response: These suggestions are inconsistent with and beyond 
the scope of the FAA's proposal. Commenters desiring these changes can 
submit separate petitions to the FAA for consideration of such actions.

Other Suggested Rule Language Changes for This Action

    The ATA comments that proposed Sec. 121.805(b)(3) should be deleted 
in its entirety. This proposed paragraph merely says, in a different 
way, what will be required by proposed Sec. 121.805(b) (1) and (2). If 
this provision is not deleted, it should be clarified that the 
``handling'' of medical events means only ``responding'' in a general 
sense. Also, although the term ``familiarization'' is a carryover from 
existing regulations, it is somewhat vague and imprecise when 
contrasted with the specific requirements set forth in Sec. 121.805 
(b)(1) and (2). If retained, this term should be explained.
    The final rule should set forth the compliance date for training in 
more direct terms than proposed, ATA states. For example, the final 
rule could state:

    The training required in this section shall be completed on [36 
months after the effective date of the final rule.

    The AFA would like the words ``programmed hours of instruction'' 
added to proposed Sec. 121.805 (b)(4)(iii). Further, proposed 
Sec. 121.805 only mentions the word ``instruction'' therefore leaving 
the reader with the implication that ``hand-on'' training would not be 
required. Not requiring ``hands-on'' training with respect to CPR and 
AED usage is not acceptable. Proposed Sec. 121.805 does not mention the 
word ``perform'' anywhere in the text of the new sub-paragraph.
    FAA Response: The FAA agrees that paragraphs (b)(1), (2), and (3) 
of Sec. 121.805 may contain redundancies as proposed and has revised 
these paragraphs based on the ATA's comment. These changes are made to 
clarify that crewmembers are not expected to know how to use but rather 
to be able to recognize, and therefore be familiar with, the content of 
the EMK's.
    The FAA agrees that it should specify, under Sec. 121.805, the 3-
year timeframe allowed before being required to carry enhanced EMK's 
and has added a new paragraph accordingly. The FAA does not a add a 
specific compliance date for completing any of the required 
instruction. As noted in the NPRM, however, the required instruction 
must be completed within 36 months after the effective date and before 
compliance is required.
    The FAA concurs with the AFA's comment and has revised Sec. 121.805 
(b)(4) accordingly. To further clarify the intent of this action, the 
FAA deletes references, that may have appeared erroneous, to 
Sec. 121.421 (under proposed paragraphs (b)(4)(i) and (ii)) and to 
Sec. 121.427 (under proposed paragraphs (b)(4) (iii)).

Reducing the Proposed 3-Year Compliance Date

    Teamsters Local 2000 (representing Northwest Airlines flight 
attendants) believes that the time has come to directly address the 
increase in passengers needing in-flight medical assistance and the 
continuing growth of passengers flying with medical conditions who are 
more likely to experience an in-flight medical event. From a realistic 
viewpoint, the proposed rule changes are long overdue. In fact, the 36-
month compliance date noted for the affected rule is in question, in 
that many U.S. air carriers have addressed many of the provisions of 
the proposal.
    FAA response: Because many of the major air carriers already comply 
or will comply with the proposal, the compliance date is an issue 
mainly for the regional air carriers. The FAA set a 3-year compliance 
date to allow those air carriers that have not made modifications 
sufficient time to provide crewmember instruction and procure medical 
enhancements.

Use of Equipment by Medical Professionals Only/International Civil 
Aviation Organization (ICAO) Standards

    The International Association of Machinists and Aerospace Workers, 
AFL-CIO, suggests permitting the use of the enhanced equipment only 
when qualified medical personnel are on board, or when a ground-to-air 
link with qualified medical personnel can be made. This would eliminate 
a flight attendant being put in the position of physician.
    It also comments that it agrees with ICAO Standards on crew 
training and equipment requirements and that the approach of the 
proposed rule is ``way beyond the scope'' of the ICAO Standard.

[[Page 19039]]

    FAA response: As explained in the NPRM, the FAA acknowledges that 
it is unrealistic to expect crewmebers to achieve the same level of 
proficiency as emergency medical personnel who perform medical 
procedures routinely on a daily basis and that this action only adds 
the option of limited in-flight medical assistance. Even in the case of 
a threat-of-death, in-flight medical event when on-board medical 
assistance is available, the certificate holder and its agents have to 
choose what assistance, if any, to provide a stricken passenger. The 
FAA does not have the authority, nor is this action intended, to 
mandate or regulate health care on board commercial air carriers; it 
can only require that the equipment be available.
    Because the FAA will be requiring AED's, while ICAO Standards and 
Recommended Practices (SARP's) do not, the FAA will exceed ICAO SARP's 
for equipment in one area. This action, therefore, does not constitute 
a serious difference. The FAA concurs with the ICAO Recommended 
Practice that it is preferable that EMK's be used by qualified and 
trained personnel but, under U.S. law, it is the certificate holder who 
makes that decision. With the advent of medical assistance via radio, 
certificate holders may choose to have less qualified personnel use the 
EMK to assist stricken passengers under the guidance of ground-based 
medical providers.

Alternative Considered

    The following are alternatives the FAA could have considered for 
this action:
     Continue case-by-case approval, without codified 
regulations, of voluntary AED carriage for those air carriers who seek 
it.
     Amend 14 CFR part 91 only and limit the action to 
providing authority for air carriers to carry AED's on board aircraft.
     Apply the proposal only to those air carriers having a 
passenger seating capacity of 51 seats or more and serviced by at least 
two flight attendants.
    The FAA determined that, absent regulations codified under part 
121, none of these options would be fully responsive to the Act and the 
majority of the commenters for the following reasons:
     Nothing would preclude air carriers from taking AED's off 
of aircraft.
     Regular maintenance and safe and appropriate usage of 
AED's could not be enforced.
     Enhanced emergency medical equipment would not be 
available on smaller air carriers.
     EMK's have been required on aircraft under 51 seats 
serviced by just one flight attendant for many years. The FAA could not 
justify allowing such aircraft to be exempt from modifications to be 
required under part 121.
     CPR instruction for flight attendants would not be 
required on all passenger-carrying aircraft. CPR, not currently 
required, is a necessary adjunct to AED usage as it must be initiated 
and 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; or the AED malfunctions.
    Adopting the final rule as proposed appears to be the most 
appropriate FAA option. The data collection conducted as directed under 
the Act revealed at least 40 events in which AED's may have been used 
had they been available. It also revealed four events in which AED's 
were available and used to shock stricken passengers; these passengers 
continue to survive today. Subsequent to the data collection, further 
FAA investigation reveals that more passengers, and a crewmember, have 
had similar experiences.
    Many public commenters request that the FAA require more emergency 
medical equipment and training than proposed. Because the FAA 
determined that these additional modifications would be burden some and 
would require supplemental notice for public comment, these requests 
could not be considered.
    Comments from the Small Business Administration (SBA), the RAA, and 
Continental Express address the economic impact of this action on small 
entities. These comments are described and analyzed in further detail 
directly below.

Summary of Economic Comments

Small Business Administration

    The SBA's comment disagrees with the FAA's statement in its NPRM 
(preliminary) evaluation that the proposed rule would not have ``a 
significant economic impact on a substantial number of small 
entities.'' The SBA notes that the FAA's NPRM evaluation estimates that 
the rule would impact 60 small air carriers, and cites to the contrary 
data from the Bureau of Census to the effect that ``scheduled air 
transportation firms totaled 715 employee firms. Of these, 452 firms 
have less than 20 employees; 192 firms have between 20 and 499 
employees. Taken together, small firms constitute 90 percent of the 
industry, not 75 percent. Only 71 firms have 500 or more employee.''
    The SBA also finds fault with the FAA's preliminary analysis as it 
concerns (a) the threshold of ``significant impact;'' (b) the cost 
estimates of AED's, EMK's, and training in terms of their being 
disadvantageous to small business in particular.
    FAA response: The FAA reviewed its preliminary analysis and now 
agrees with the SBA that this rule will have ``a significant economic 
impact on a substantial number of small entities,'' according to the 
SBA formula. However, the FAA finds that the burden is neither as 
significant nor is the number of small entities as substantial as the 
SBA presents. As shown in Table A of the Regulatory Flexibility 
Analysis (see page 22 of the Final Rule Regulatory Evaluation on file 
in the Docket), this rule will impact 28 small businesses. Of these, 17 
will be significantly impacted. A full discussion of the impact of this 
rule on these small businesses is provided in the Regulatory 
Flexibility Analysis. This section of the final rule Regulatory 
Evaluation also details the procedure by which the 28 small air 
carriers were identified. As noted in the Regulatory Flexibility 
Analysis section of the Regulatory Evaluation on file in the Docket, 
the FAA used the Fleet PCTM database product maintained by 
Back Associates, Inc., first to identify all the rule-designated 
airplanes (those with maximum payloads greater than 7,500 pounds) that 
are active or inactive (for example, undergoing maintenance checks) 
used in civil aviation by U.S. operators, and then to match the 
airplanes with their operators. The resulting data were further pared 
down to eliminate cargo operations, non-part 121 operations, businesses 
that have 1,500 or more employees, businesses that are owned as 
subsidiaries by other businesses, and businesses that are decertified 
or are otherwise operationally dormant. This approach ensured that the 
FAA would not omit any affected, certificated air carrier.
    The group of small air carriers that resulted from this process is 
volatile. Within this group, between September, 1998 and September, 
2000:
     DOT certificated six airlines to start operations;
     DOT recertificated a previously dormant airline;
     DOT decertificated four airlines, three for dormancy and 
one for cause; and three airlines were in Chapter 11 (reorganization) 
bankruptcy.
    For this analysis, all the newly certificated airlines and the re-
certificated airline were assumed to be subject to this rule. In August 
1999, one

[[Page 19040]]

of thre three bankrupt airline emerged from the Chapter 11 bankruptcy 
of its parent company. Because it had not suspended its operations 
during bankruptcy, because it is a non-subsidiary, and because it 
reported financial data to the FAA, it is included in this analysis as 
subject to this rule.
    As shown in Table A of the section on Regulatory Felxibility (see 
page 22 of the final rule Regulatory Evaluation, on file in the Docket) 
the FAA determined that only 28 carriers \3\ with no more than 1,500 
employees are certificated by the FAA to conduct operations subject to 
this rule.
---------------------------------------------------------------------------

    \3\ In December, 2000, one of the small carriers included in 
this group suspended operations and sought Chapter 11 bankruptcy 
protection. This analysis does not reflect that event.
---------------------------------------------------------------------------

    The FAA's estimate of this rule's average initial burden on these 
small business carriers is $43,301. In no case is this amount more than 
one percent of any carrier's annual operating revenue, even though for 
this analysis, the FAA assumes that these carriers will bear all the 
initial cost of compliance in the first year of effectiveness, rather 
than spread the costs over the first 36 months of effectiveness, as the 
rule permits. The follow-on burdens of operation and upkeep were 
ignored in this analysis because (a) they are much smaller than the 
initial costs, (b) the financial data are limited, and (c) this carrier 
size category displays short business life spans. However, because 17 
of these carriers reported negative net operating revenue for the 
immediately preceding reporting period (generally, which ended June 30, 
2000), the FAA reasoned that these 17 could not pay the costs of 
compliance from current net revenue. The FAA concludes this rule will 
have ``a significant impact'' on these 17 carriers. The FAA's final 
estimate of AED costs is $3,140, ready for use in flight. This estimate 
was produced by combining the list price of the device with prices 
known to have been paid by air carriers already in voluntary 
compliance. The FAA's attenpts to learn vendor discount policy resulted 
in the information that such policy was confidential, that a discount 
could be given on as small an order as one AED, and that other factors, 
such as early or prominent adoption, also account for discounts. Thus, 
the FAA can make no conclusive statement on the availability of 
discounts on AED's.
    For this final rule Regulatory Evaluation, based on comments, 
updates, and clarifications, the FAA also revised its estimates of 
costs of AED's, EMK's and training from the values noted by SBA. The 
FAA agrees with the SBA that the costs of complying with the rule will 
fall disproportionately on small carriers, because 90 percent of the 
affected air carrier industry (based on revenue passenger miles) is 
known to already have initiated voluntary compliance. This 90 percent 
includes all but one of the major air carriers and many of them small 
airlines, will bear the burden of compliance with this rule when it 
becomes effective.
    In clarifying earlier comments to the FAA, one of the two major 
vendors of AED's noted that discounts had been given on orders as small 
as a single unit. This vendor noted that early or prominent adopters 
were as likely as volume buyers to be given discounts.

Regional Airline Association

    The RAA's comments include suggestions that the applicability of 
the rule be limited to operations that require at least two flight 
attendants, and that further study be devoted to the feasibility of use 
of AED's and enhanced EMK's on airplanes typically operated by RAA 
members.
    FAA response: This FAA response replies only to the economic and 
not to the physical or operational feasibility implications of this 
rule, which the FAA already has discussed above. Table B of the 
Regulatory Flexibility Analysis (see page 28 of the Regulatory 
Evaluation, on file in the Docket), shows that of 185 RAA members, only 
28 will be impacted by this rule. Fifteen of the 28 are subsidiaries of 
larger businesses. Nine more non-subsidiary air carriers have code-
sharing or other affiliation arrangements with other, larger 
businesses.
    One thousand two hundred and fifty-nine airplanes of the total 
fleet of airplanes operated by these 28 air carriers will be subject to 
this rule. Only 132 of these airplanes offer 51 or more seats and thus 
require two or more attendants. The FAA has no reason to believe that 
the population of passengers on the 30-50 seat airplanes operated by 
RAA members is different in terms of its medical needs than the 
passengers on the 627,956 American Airlines departures equipped with 
AED's on which AED use was studied in 1997-1999. Thus the FAA believes 
that similar benefits would be generated on flights by RAA members and 
by American Airlines, when those flights are operated subject to this 
rule. Because the FAA in its regulatory evaluation determined this rule 
to be cost-beneficial, the FAA believes that applying this rule only to 
132 of the 1,259 affected airplanes operated by RAA members would be 
likely to be less cost-beneficial than applying it to all.

Continental Express

    As above, this response addresses only specific economic comments. 
Continental Express provides very detailed cost estimates of its burden 
of complying with the rule. The Continental Express comment extends 
item cost estimates for AED's, EMK's, and training, to its fleet and to 
its staff of attendants.
    FAA response: Generally, the FAA accepted Continental Express's 
cost breakdown structure categories and incorporated them into its 
final rule evaluation. The FAA did not accept all of its estimates of 
item cost.
    The FAA believes that its estimate more closely resembles actual 
industry practice than Continental Express' estimate. The FAA's 
procedure (shown in Tables 2, 3, and 4 of the Regulatory Evaluation, on 
file in the Docket) tracked the provisions of the rule that allow each 
carrier 36 months to bring its existing fleet and staff into 
compliance. Thus, the FAA estimated costs separately for each of the 10 
years of the period of analysis including 2001 through 2011 and 
discounted each annual total to its present value. In contrast, 
Continental Express provides 10-year lump sum totals.
    The FAA's estimate also differed from Continental Express' in 
distinguishing between the existing fleet of airplanes that require 
only to have their EMK's brought up to enhanced status (1,194 airplanes 
at $155 each) and those newly added airplanes added annually at 4.1 
percent growth rate to the fleet from 2001 (49) through 2011 (70 at 
$514 each).
    The FAA accepted Continental Express' assertion of the need to 
annually train the attendants who must be hired to replace those lost 
through attrition at the annual rate of 20 percent. The FAA used the 
same elements and rates of cost that Continental Express provided for 
its training cost estimate, but the FAA believes this training is 
better characterized as taking one day instead of two. Thus, the FAA 
maintains Continental Express' training cost of 4 hours of flight pay 
credit per day of training cost of 4 hours of flight pay credit per day 
of training at $28 per hour, but applies it to one day. The FAA retains 
the Continental Express estimate of $94 per night for lodging for one 
night, but applies the estimate of $32.40 per diem allowance to only 
one day.
    The FAA reduced Continental Express' estimate of $3,500 per AED to 
$3,000 to reflect prices known to have been paid by air carriers. The 
FAA

[[Page 19041]]

retained Continental Express' estimate of $140 for installation. The 
FAA departed from Continental Express' estimate of $30 to enhance 
existing EMK's, and continued to rely on its NPRM cost of $155 for 
enhancement only for the fleet in existence at the base year, 2000. For 
the new airplanes to be added annually afterward, the FAA used the list 
price of $514 for the bottom-of-the-line enhanced EMK. In summary, to a 
great extent, the FAA incorporated Continental Express' economic 
comments into its estimate.
    However, as the FAA shows in Table B of the Regulatory Flexibility 
Analysis (on file in the Docket), and also as reported on the Form 10K 
report filed for the year 1999 by Continental Airlines, Inc., with the 
Securities and Exchange Commission of the United States, Continental 
Express is a wholly-owned subsidiary of Continental Airlines, Inc., 
which already has initiated voluntary compliance with this rule. This 
relationship implies that the cost burden presented by Continental 
Express would be borne by its parent, Continental Airlines, Inc., in a 
manner similar to that in which other parent corporations, such as AM 
Corp., Inc., already bear the cost of voluntarily equipping their 
wholly-owned subsidiaries, such as American Airlines, Inc., and 
American Eagle Holding Company (American Eagle) Inc., to comply with 
this rule.

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 kids'' 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 those 
ICAO SARO'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 has added 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 in the use of 
emergency and life-saving equipment required to be carried, such as * * 
*, first-aid kits.'' Existing Secs. 121.417 and 121.805 comply with 
these ICAO guidelines.
    ICAO SARPS do not address AED usage on aircraft.

Executive Order 12866 and DOT Regulatory Policies and Procedures

    Executive Order 12866, Regulatory Planning and Review, directs the 
FAA to assess both the costs and benefits of a regulatory change. We 
are not allowed to propose or adopt a regulation unless we make a 
reasoned determination that the benefits of the intended regulation 
justify its costs. Our assessment of this proposal indicates that its 
economic impact is minimal.

Economic Evaluation, Regulatory Flexibility Determination, Trade Impact 
Assessment, and Unfunded Mandates Assessment

    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 impact of regulatory changes on small entities. Third, the 
Trade Agreements Act (19 U.S.C. section 2531-2533) prohibits agencies 
from setting standards that create unnecessary obstacles to the foreign 
commerce of the United States. In developing U.S. standards, this Trade 
Act requires agencies to consider international standards and, where 
appropriate, that they be the basis of U.S. standards. Fourth, the 
Unfunded Mandates Reform Act of 1995 requires agencies to prepare a 
written assessment of the costs, benefits and other effects of proposed 
or final rules that include a Federal mandate likely to result in the 
expenditure by State, local or tribal governments, in the aggregate, or 
by the private sector, or $100 million or more, in any one year 
(adjusted for inflation).
    In conducting these analyses, the FAA has determined that this 
rule: (1) Has benefits which do justify its costs, is not a 
``significant regulatory action'' as defined in the Executive Order but 
is ``significant'' as defined in DOT's Regulatory Policies and 
Procedures; (2) will have a significant impact on a substantial number 
of small entities; (3) has a minimal impact on international trade; and 
(4) does not impose an unfunded mandate on state, local, or tribal 
governments, or on the private sector. These analyses, available in the 
Docket, are summarized below.

The Evolution of the Estimates of Benefits and Costs

    While this final rule evaluation derives directly from the NPRM 
evaluation, the cost estimates are lower and the benefits estimates are 
higher for the final rule than for the NPRM. The reasons for these 
differences are as follows:
     The extent of voluntary compliance by affected carriers 
has increased since the NPRM was issued. The carriers known to have 
initiated voluntary compliance account for about 90 percent of revenue 
passenger miles flown by carriers subject to this final rule. Thus, 
this analysis applies only to those carriers not now in voluntary 
compliance;
     The increased extent of voluntary compliance reduced the 
base year fleet and staff estimates for non-complying carriers from 
2,600 to 1,194 airplanes, and from 54,400 to 25,500 attendants;
     The final rule evaluation assumed currently non-complying 
carriers would take the full 36 months allowed by the rule to equip 
their existing airplanes and to train their existing attendants;
     Reviewing, updating, and clarifying the comments to the 
NPRM resulted in

[[Page 19042]]

the upward revision of the costs of some items, including training and 
the fully enhanced EMKs, and in its downward revision of the costs of 
the AEDs; and
     Review of a study published in the October 26, 2000 New 
England Journal of Medicine resulted in revising the estimated ten-year 
forecasts of averted (statistical) fatalities upward from 55 to 94.8.

The Estimate of Benefits

Quantifiable Benefits

    The FAA estimate of the total benefits is based principally on the 
findings of a study based on American Airlines operations and published 
in the New England Journal of Medicine October 26, 2000. Considering 
only those passengers flying on carriers not already in voluntary 
compliance, the FAA expects the number of fatalities averted because of 
this rule becoming effective will total to 95 over the 10-year period 
of analysis that includes 2001 through 2010. This total compares to the 
55 of the NPRM evaluation.
    Based on the $2,700,000 value of an averted fatality, the total 
quantifiable safety benefit over the ten year period of analysis is 
about $176.8 million dollars, when discounted at seven percent annually 
to its present (year 2000) value as prescribed by OMB. Viewed over 10 
years, this discounted value converts to uniform annual benefits of 
about $25.2 million dollars.

Unquantifiable Benefits

    The FAA has identified but has not attempted to quantify benefits 
from the availability of enhanced EMK's, and also from the use of AED's 
apart from the benefits of defibrillation. Incidental to their use in 
defibrillation, AED's detect and provide electrocardiographic (EKG's) 
parameters of passenger/patients. Properly interpreted by a passenger/
physician, these EKG's possibly can rule out the necessity for 
diverting a flight, as otherwise might be determined prudent absent a 
properly interpreted EKG readout. Further, the availability of on-board 
enhanced EMK's for use by a passenger/physician could rule out the 
necessity of diverting a flight. Because flight diversions are costly, 
their reduction is a benefit, but the FAA has not attempted to quantify 
it.

The Estimate of Costs

    The comments to the NPRM resulted in the FAA's upward revision of 
the costs of some items, including AED's, enhanced EMK's and training. 
For example, the vendor's list price of $514 for the entry-level EMK 
was determined to be a more accurate reflection of carriers' costs than 
was the NPRM estimate. The FAA estimate of initial training costs was 
raised from its NPRM value of $151 to $238.40. The new estimate 
reflects partial acceptance of the costs provided by a commenter who 
postulated 2 days of initial training at $384. The FAA estimate applies 
that commenter's cost elements over 1 day of training. For this final 
rule evaluation, a 20 percent annual attrition rate among attendants 
was included in the computation of training costs. The cost of a 
defibrillator was decreased from its NPRM $3,500 list price to $3,000, 
reflecting reports of actual pricing. Installation costs of $140 were 
added to this acquisition cost. The annual operational cost of the 
current generation of AED batteries and pads was increased to $157.50 
from $100 as clarified and updated by a vendor/commenter.
    For AED's EMK's and training, this final rule evaluation assumes 
each affected carrier not already in voluntary compliance will spread 
fleet complianace over the full 36 months allowed by the rule. This 
means that for AED's and enhanced EMK's the base year 2000 fleet of 
1,194 airplanes will be brought to compliance at the rate of one third 
of this fleet or 398 airplanes per year. In like manner, the base year 
complement of about 25,500 attendants to be trained will be trained at 
8,481 per year until all are trained.
    These estimates also incorporated new airplanes and new attendants 
assumed to be added annually in step with FAA estimates of industry 
growth. Finally, this estimate included one-half day of recurrent 
training at 2-year intervals.
    The FAA totaled all the expected costs over the 10-year period 
including 2001 through 2010 (the period of analysis) of this regulatory 
proposal. The present value of this cost stream was calculated using a 
discount factor of seven percent annually.
    The FAA's estimates of the costs of this final rule are as follows:

AEDs.......................................................   $5,759,129
Enhanced EMKs..............................................    1,692,184
Training...................................................    8,848,821
Fuel weight penalty........................................      319,860
                                                            ------------
      Total................................................   16,619,994
Uniform Annual Cost over ten years.........................    2,366,687
 

Benefits/Costs Comparison

    Discounted to their present (year 2000) value, the benefits of this 
rule are about $176.8 million. The present value of the total costs of 
this rule is about $16.6 million dollars. Viewed over the 10-year 
period of analysis, the comparison of uniform costs and benefits is 
about $25.2 million dollars annually for benefits and about $2.4 
million dollars annually for costs. This final rule is cost beneficial.

Regulatory Flexibility Determination

    The Regulatory Flexibility Act of 1980 (RFA) was enacted by 
Congress to ensure that small entities (small business and small not-
for-profit government jurisdictions) are not unnecessarily and 
disproportionately burdened by Federal regulations. The RFA, which was 
amended March 1996, requires regulatory agencies to review rules to 
determine if they have ``a significant economic impact on a substantial 
number of small entities.'' The Small Business Administration defines 
small entities to be those airlines with 1,500 or fewer employees for 
the air transportation industry.
    For this final rule, the small entity group of interest is drawn 
from among those air carriers that are certificated by the FAA to 
operate under 14 CFR part 121, and which have 1,500 or fewer employees. 
The final rule specifically applies to the use by such carriers of 
airplanes that have maximum payloads of more than 7,500 pounds and 
more. Although this rule also encompasses air carriers certificated to 
operate under 14 CFR part 135, the rule as it regards them includes 
only a non-substantive editorial change, with no economic impact. Thus 
for operators certificated under 14 CFR part 135, the economic impact 
of this final rule on such carriers is negligible.
    The FAA determined this final rule will have a significant economic 
impact on a substantial number of small entities. Twenty-eight small 
business air carriers will feel the impact of this rule. To ensure that 
the estimated burden of these small carriers would not be understated, 
the FAA assumed they would undertake to comply with the rule within 1 
year, instead of the 3 allowed. In no case was the actual burden 
estimated to be greater than one percent of annual operating income. 
However, because 17 of these carriers had negative net operating income 
for the year that ended June 30, 2000, the FAA stipulates that these 
carriers cannot meet the costs of this rule out of their operating 
income.

International Trade Impact Assessment

    The Trade Agreement Act of 1979 prohibits Federal agencies from 
engaging in any standards or related activities that create unnecessary 
obstacles to the foreign commerce of the United States. Legitimate 
domestic

[[Page 19043]]

objectives, such as safety, are not considered unnecessary obstacles. 
The statute also requires consideration of international standards and 
where appropriate, that they be the basis for U.S. standards. In 
addition, consistent with the Administration's belief in the general 
superiority and desirability of free trade, it is the policy of the 
Administration to remove or diminish to the extent feasible, barriers 
to international trade, including both barriers affecting the export of 
American goods and services to foreign countries and barriers affecting 
the import of foreign goods and services into the United States.
    In accordance with the above statute and policy, the FAA has 
assessed the potential effect of this final rule and has determined 
that it will have little or no effect on trade-sensitive activities. 
U.S. carriers that have voluntarily upgraded their emergency medical 
equipment account for a majority of the U.S.-flag international 
service. The FAA believes that the popularity among U.S. carriers of 
the provisions of this rule extends to foreign carriers in 
international flights to and from the United States. The FAA is aware 
that many foreign carriers carry AEDs on flights to and from the United 
States. Among those of which the FAA is aware are the following: Aegean 
Airlines; Air Canada; Air Zimbabwe; British Airways; Cathay Pacific; 
Emirates Airlines; Finnair; Iberia; Malev; Quantas; Swiss Air; Varig; 
And Virgin Atlantic.

Final Unfunded Mandates Assessment

    The Unfunded Mandates Reform Act of 1995 (the Act.), enacted as 
Pub. L. 104-4 on March 22, 1995, is intended, among other things, to 
curb the practice of imposing unfunded Federal mandates on States, 
local, and tribal governments.
    Title II of the Act requires each Federal agency to prepare a 
written statement assessing the effects of any Federal mandate in a 
proposed or final agency rule that may result in a $100 million or more 
expenditure (adjusted annually for inflation) in any one year by State, 
local, and tribal governments, in the aggregate, or by the private 
sector; such a mandate is deemed to be a ``significant regulatory 
action.''
    This final rule does not contain such a mandate. Therefore, the 
requirements of Title II of the Unfunded Mandates Reform Act of 1995 do 
not apply.

Executive Order 13132, Federalism

    The FAA has analyzed this final rule under the principles and 
criteria of Executive Order 13132, Federalism. We determined that this 
action will not have a substantial direct effect on the States, or the 
relationship between the national Government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government. Therefore, we determined that this final rule does not have 
federalism implications.

Environmental Analysis

    FAA Order 1050.1D defines FAA actions that may be categorically 
excluded from preparation of a National Environmental Policy Act (NEPA) 
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) Pub. L. 94-163. as 
amended (42 U.S.C. 6362) and FAA Order 1053.1. It has been determined 
that the final rule 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 Amendment

    In consideration of the foregoing, the Federal Aviation 
Administration amends 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, 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 
Secs. 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,

[[Page 19044]]

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. Nothing in this subpart 
is intended to require certificate holders or its agents to provide 
emergency medical care or to establish a standard of care for the 
provision of emergency medical care.


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.
    (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.
    (3) In airplanes for which a flight attendant is required, an 
approved emergency medical kit as modified effective April 12, 2004.
    (4) 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 April 12, 2004.


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 emergency medical event procedures, including 
coordination among crewmembers.
    (2) Instruction in the location, function, and intended operation 
of emergency medical equipment.
    (3) Instruction to familiarize crewmembers with the content of the 
emergency medical kit.
    (4) Instruction to familiarize crewmembers with the content of the 
emergency medical kit as modified on April 12, 2004.
    (5) For each flight attendant--
    (i) Instruction, to include performance drills, in the proper use 
of automated external defibrillators.
    (ii) Instruction, to include performance drills, in cardiopulmonary 
resuscitation.
    (iii) Recurrent training, to include performance drills, in the 
proper use of an automated external defibrillators and in 
cardiopulmonary resuscitation at least once every 24 months.
    (c) The crewmember instruction, performance drills, and recurrent 
training required under this section are not required to be equivalent 
to the expert level of proficiency attained by professional emergency 
medical personnel.

    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:

------------------------------------------------------------------------
                                                                 No. of
                    No. 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                             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

[[Page 19045]]

 
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. Until April 12, 2004, 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, cropharyngeal (3 sizes)...............  3
Syringes (sizes necessary to administer          4
 required drugs).
Needles (sizes necessary to administer required  6
 drugs).
50% Dextrose injection, 50cc...................  1
Epinephrine 1:1000, single dose ampule or        2
 equivalent).
Diphenhydramine HC1 injection, single dose       2
 ampule or equivalent.
Nitroglycerin tablets..........................  10
Basic instructions for use of the drugs in the   1
 kit.
protective nonpermeable gloves or equivalent...  1 pair
------------------------------------------------------------------------

    2. As of April 12, 2004, at least one approved emergency medical 
kit that must contain at least the following appropriately 
maintained contents in the specified quantities:

------------------------------------------------------------------------
                    Contents                             Quantity
------------------------------------------------------------------------
Sphygmonanometer...............................  1
Stethoscope....................................  1
Airways, oropharyngeal (3 sizes): 1 pediatric,   3
 1 small adult, 1 large adult or equivalent.
Self-inflating manual resuscitation device with  1:3 masks
 3 masks (1 pediatric, 1 small adult, 1 large
 adult or equivalent).
CPR mask (3 sizes), 1 pediatric, 1 small adult,  3
 1 large adult, or equivalent.
IV Admin Set: Tubing w/ 2 Y connectors.........  1
    Alcohol sponges............................  2
    Adhesive tape, 1-inch standard roll          1
     adhesive.
    Tape scissors..............................  1 pair
    Tourniquet.................................  1
Saline solution, 500 cc........................  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    4
 to administer required medications).
Analgesic, non-narcotic, tablets, 325 mg.......  4
Antihistamine tablets, 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).
Aspirin tablets, 325 mg........................  4
Bronchodilator, inhaled (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).
Nitroglycerin tablets, 0.4 mg..................  10
Basic instructions for use of the drugs in the   1
 kit.
------------------------------------------------------------------------

    3. If all of the above-listed items do not fit into one 
container, more than one container may be used.

Automated External Defibrillators

    At least one approved automated external defibrillator, legally 
marketed in the United States in accordance with Food and Drug 
Administration requirements, 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 as approved by the 
Administrator.
    3. Be maintained in accordance with the manufacturer's 
specifications.

PART 135--OPERATING REQUIREMENTS: COMMUTER AND ON-DEMAND OPERATIONS 
AND RULES GOVERNING PERSONS ON BOARD SUCH AIRCRAFT

    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) * * *

[[Page 19046]]

    (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 pair
------------------------------------------------------------------------

* * * * *

    Issued in Washington, DC, on April 6, 2001.
Jane F. Garvey,
Administrator.
[FR Doc. 01-8932 Filed 4-11-01; 8:45 am]
BILLING CODE 4910-13-M