December 29

, 2015

U.S. Department of Transportation

Docket Operations

West Building Ground Floor, Room W12

- 140

1200 New Jersey Avenue, SE

Washington, DC 20590

Subject: Petition for Exemption

Reference: Emergency Medical Equipment; 14 CFR 121.803

.

Dear Sir or Madam:

In accordance with the provisions of Title 14, Code of Federal Regulations (14 CFR) §11.63 and §11.81,

Airlines for America, the National Air Carrier Association

, and the Regional Airline Association, on behalf of

their passenger airline mem bers (See enclosure 1) and similarly

- situated air carriers, petition for a limited

exemption from 14 CFR §121.803(c)(3) which requires airplanes with seating capacity of more than nine

passengers to carry an Emergency Medical Kit (EMK) with contents as spe cified in Appendix A to Part 121.

Specifically, we request that FAA issue a long

- term exemption for use during periods of temporary supply

shortages

, beyond operator control, affecting availability of injectable drugs Atr opine, Dextrose, Lidocaine,

or Epinephrine, named in Part 121, Appendix A.

Background

Since 1986, large passenger

- carrying aircraft have been required to carry a n EMK to assist crewmembers

or other volunteers in responding to an in

- flight medical emergency. 1 That requirement was extended in

1996 to cover 20

- 30 seat commuter aircraft. 2 In 2001, the Federal Aviation Administration (FAA) issued

new regulations implementing the Aviation Medical Assistance Act of 1998, which among other provisions

called for airli nes to augment their EMKs and include Atropine

, Dextrose, Lidocaine, and Epinephrine

. 3 The

regulatory provision expanding the required contents of the EMK took effect April 12, 2004, and applies to

all airplanes for which a flight attendant is required, 4 w hich currently includes all passenger

- carrying aircraft

having a seating capacity of more than nine passengers. 5 The EMK is considered a “no

- go” item that must

be on board for the airplane to be operated, 6 and current Master Minimum Equipment List (MMEL) r elief

requires a carrier to repair or replace an EMK within one flight of an incomplete, missing or inoperative

EMK ; there is no MEL relief permitting a carrier to depart with an EMK missing any specified contents

beyond the one flight relief described abo ve

. 7

Shortages occur due to multiple factors including overall non

- aviation demand and manufacturing shortfall s

, and relates not simply to shortages of substance, but also shortages of prescribed aviation packaging

(ampules/pre

- filled syringes or proper dosages )

. Refurbishers report that they are often unaware of an

impending drug shortage until they experience a back

- order notification. The Atropine and Dextrose

shortages in 2012

- 2014 are good examples of drug shortages that surfaced with little notice. The FDA does

1 Emergency Medical Equipment Requirements Rule, 51 Fed. Reg. 1218 (Jan. 9, 1986).

2 60 Fed. Reg. 65831 (Dec. 20, 1995).

3 66 Fed. Reg. 19028 (April 12, 2001).

4 14 C.F.R. §121.801(c)(3).

5 14 C.F.R. §121.391(a)(1).

6 See 66 Fed. Reg 19033.

7 See FAA MMEL Policy Letter 73, “MMEL Relief for Emergency Medical Equipment.”not require timely manufacturer drug shortage notices and therefore, FDA is not a source for advance

information.

Suppliers/refurbishers, led by MedAire and Banyan also regularly compete with hospitals and other ground

based users to obtain these drugs

. Hospitals and first responders use the substance s more often than they

discard it through expiration (as usually occurs in aviation)

. For example, Banyan reported that d uring one

shortage, producers adopted an Atropine distribution system that placed acute care providers (such as

hospitals) ahead of airlines ; and even with this system acute care providers were not receiving enough

supply, making it even less likely that EMK providers would receive Atropine.

Thus far, airlines and their kit supp liers have been able to address temporary shortages through a variety

of accommodations and FAA exemptions

. Ordinarily, airlines maintain a certain number of extra EMKs to

replace those that are opened during a medical event ; the opened EMKs are then sent back to the kit

supplier for refurbishment. In addition, all EMKs are restocked periodically since some of the medications

they contain have a shelf

- life of as little as one year. However, during a shortage, EMKs in which Atropine

, Dext rose, Lidocaine, or Epinephrine have been used or have expired cannot be refurbished and returned

to use, leaving the airline potentially without the means to comply with the requirements of Appendix A.

Also, while FDA has the authority to extend the expiration date on the drugs, the drug manufacturer must

petition the FDA with drug stability data asking for an extension, which no manufacturer has done. Finally,

Appendix A permits carri ers and suppliers to provide equivalent substances

, however, accord ing to MedAire

(and confirmed by in house air carrier medical staff) there is no equivalent substitute for Atropine

, for

example

.

Previous Petitions for Exemption and Subsequent Operator Action

The petitioners requested and were granted separate exemptions for Atropine and Dextrose on very short

notice in early 2013 8

. With subsequent extensions, these Exemptions currently expire on January 31, 2016

and M arch 31, 2016 respectively. A petition was submitted in 2010 regarding Epinephrine was withdrawn

as supply recovered

.

The pattern established by the short

- fused Atropine and Dextrose petitions, and the aborted Epinephrine

petition, reflect the uncertainties of information flowing from the manufacturers. For apparently commercial

reasons, shortage dur ations vary widely and are not commu nicated in a timely manner to suppliers and

refurbishers of EMKs (principally MedAire and Banyan).



### I t is important to note that suppliers of EMKs and the operators have unwaveringly demonstrated their

responsibility to the public by placing the drugs in EMKs whenever the products have been available, e ven

during periods of exemption.

The lack of timely predictability of shortages, taken with the highly responsible behavior of kit suppliers and

operators, together undersc ore the appropriateness of a long

- term Exemption that will be used only when

supplies are impaired beyond their control.

8 Exemption 10690, issued January 25, 2013 and Exemption 10721, issued March 14, 2013.Current Shortage s

Currently only Hospira is reporting a potential disruption of the four injectables in the first quarter of 2016.

Specifically, there is a possible recall of pre

- filled syringes impending. This was disclosed to A4A by Banyan

on or about December 9, 2015.

 Atropine

Atropine , a required component of EMKs since 2004, is a “ medicine use d mainly to increase heart rate that

may be needed to assist a passenger with an unstable cardiac rhythm. ” 9 Part 121, Appendix A specifies

that an EMK must include two Atropine 0.5 mg, 5 cc injectable single dose s or an Atropine equivalent

.

M ajor EMK airline suppliers and refurbishers MedAire

, Inc. and Banyan Int ernational Corporation, obtain

Atropine from four producers in the United States, Amphastar Pharmaceuticals Inc.

, Hospira, Inc.

, American

Regent/Luitpold

, and West

- Ward Pharmaceuticals

. 10 In Banya n ’s letter that accompanied the first petition

addressing Atropine, they pointed out that t here are no FDA

- approved foreign Atropine manufacturers

authorized to import Atropine into the U.S. to relieve the shortage.

 Dextrose

Dextrose, a requir ed component of EMKs since 1986

, is a “medicine used to treat acute or severe

hypoglycemia which may appear in diabetic passengers. ” 11 Part 121, Appendix A specifies that an EMK

must include one Dextrose 50%/50 cc injectable single dose or a Dextrose equivalent.

M ajor EMK airline suppliers and refurbishers MedAire, Inc. and Banyan International Corporation, obtained

Dextrose from two producers in the United States, Amphastar Pharmac euticals Inc. and Hospira, Inc. 12

Appendix A permits carriers and suppliers to provide a Dextrose equivalent and Med Aire states two

Dextrose 25% doses (equivalent to one 50% dose) or one 1mg Glucagon dose (providing similar

therapeutic effects) would be equally effective alternatives but the future availability of these alternative

drugs is also unpredictable

.

 Epinephri ne

Epinephrine

, a required component of EMKs since 2004, is a “ medication used mainly for cardiac

resuscitation

. ” 13 Part 121, Appendix A specifies that an EMK must include two 1:1000, 1cc single dose

ampules and two 1:10,000, 2cc single dose ampules of Epinephrine or respective equivalents.

M ajor EMK airline suppliers and refurbishers MedAire, Inc. and Banyan Int ernational Corporation, obtain

Epinephrine from four producers in the United States, Amphastar Pharmaceuticals Inc., Hospira, Inc.,

American Regent/Luitpold, and Par Pharmaceuticals. 14

 Lidocaine

Lidocaine

, a required component of EMKs since 2004, is a “medication used mainly in cases of

unrespo nsiveness to defibrillation and possibly for maintenance of normal heart rhythm after successful

9 See 65 FR 33726; FAA Advisory Circular AC

- 121

- 33B, “Emergency Medical Equipment,” January 12

, 2006

. 10 See FDA website concerning “Atropine Sulfate Injection” manufacturers at

http://www.accessdata.fda.gov/scripts/drugshortages/default.cfm

See also http://www.medaire.com/solutions/airlines/solutions/medical

- kits

- equipment/medical

- equipment

- details ; and

http://www.statkit.com/aviation

- medicine/aviation

- medicine

- and

- banyan

- 9

- 9.html

11 65 FR 33726; FAA Advisory Circular AC

- 121

- 33B

12 FDA website

13 65 FR 33726; FAA Advisory Circular AC

- 121

- 33B

14 FDA websitedefibrillation ”. 15 Part 121, Appendix A specifies that an EMK must include two 5 cc, 20 mg/ml, injectable

(single dose ampule or equivalent) of Lidocaine.

Major EMK airline suppliers and refurbishers MedAire, Inc. and Banyan International Corporation, obtain

Epinephrine from four producers in the United States, Amphastar Pharmaceuticals Inc., Hospira, Inc.,

Aurobinda Pharma, and Fresenius Kabi USA, LLC

. 16 Ame rican Regent/Luitpold recently announced

discontinuance of production.

The Applicable Regulations and Relief Sought

We seek long

- term exemption from 14 CFR 121.803(c)(3)

, which requires passenger

- carrying airplanes to

be equipped with an EM K containing Atropine

, Dextrose, Lidocaine, or Epinephrine as specified in part 121

Appendix A, EMK requirements, paragraph 2 during periods of supply disruptions beyond the control of the

EMK suppliers and the operators, which may be on a kit

- by

- kit basis, with approp riate labeling of the kits

indicating the shortage.

R easons for seeking the relief include:

1) Suppliers cannot provide EMKs stocked with the drugs when pharmaceutical m anufacturers

do not deliver product and have not supplied revised fulfillment dates

. 2) Replacement supplies of these substances cannot be imported from foreign manufacturers

. 3) There is no accepted substitute for Atropine , and where substitutes for other drugs may exist,

their supplies are no more dependable.

4) These drugs are rarely used;

 Bany an estimates that Atropine is used less than one time per one thousand units serviced

 Dextrose is rarely used; having been recommended during approximately .02% in

- flight

consultations provided by MedAire in 2012. Banyan estimates that Dextrose has used in

less than 0.4% of inflight emergencies reported to them in 15 years.

 Ep inephrine is also rarely used, having been administered in 0.3% of inflight medical

emergencies per a 2013 study by the New England Journal of Medicine

. 17

 Lidocaine i s even more rarely used, aggregated within “other” by the footnoted NEJM

study.

5) When operators contact A4A indicating their supply of EMKs with unexpired Atropine

, Dextrose, Lidocaine, or Epinephrine will be depleted soon, the problem is often merely weeks

away, with potential service disruption looming.

Without the requested relief

, carriers will periodically and with little notice face the decision to ground

aircra ft

.

Therefore, w e request long

- term relief from the requirement to carry Atropine

, Dextrose, Lidocaine, or

Epinephrine in an EMK that has a shortage resulting from uncontrollable supply deficit

.

Granting the Exemption Would be in the Public Interest

Absent this relief, there is no means for airlines to comply with section 121.803

, part 121 Appendix A, and

MEL requirements when shortages exist and the drugs need to be restocked in the EMK. This creates the

possibility that aircraft would have to be taken out of service until additional supplies can be obtained. While

this would be a last resort, it is not implausible. Grounding otherwise airworthy aircraft for this reason alone

would disrupt air service and is not in the interest of the traveling public. Granting this exemption would help

to ensure that air service continues uninterru pted and in this respect would serve the public interest.

15 65 FR 33726; FAA Advisory Circular AC

- 121

- 33B

16 FDA website

17 “Outcomes of Medical Emergencies on Commercial Airline Flights”, Peterson, Drew C. M.D., et. al., The New England Journal of

Medicine , May 30, 2013Granting the Exemption Would Not Adversely Affect Safety

The shortage s of these drugs to date have additionally brought to light their limited usage

. For example,

MedAire has reported that roughly 1% of EMKs returned for refurbishment are missing Atropine due to use,

loss, or damage. A returned EMK, unless opened for use, represents approximately one year of service

and is generally returned for replacement of expiring con tents. MedAire and Banyan have both reported to

A4A qualitatively that the predominance of drug usage for airline purposes has been due to expiration, not

administration to passengers. For example, Banyan reports that Atropine is used less than one time p er

one thousand units serviced. As previously referenced, usage of the other injectables is also rare.

We reiterate, s uppliers of EMKs and the operators have unwaveringly demonstrated their responsibility to

the public by placing the drugs in EMKs

, even during periods of exemption, whenever the products have

been available.

EMKs are not intended to be comprehensive, or to include treatment for every possible medical condition,

but instead provide options for addressing the most frequent types of med ical emergencies. 18 The case

by

- case removal of the EMK requirement for these drugs during acute shortages would not adversely affect

the safety of the traveling public because they is used so infrequently

. 19

A S ummary of this P etition that FAA C ould P ublish in the Federal Register

Petitioners: Airlines for America, the National Air Carrier Association, and

the Regional Airline Association

Affected Regulations: 14 CFR 121.803(c)(3) and 14 CFR part 121, Appendix A

- First Aid Kits

and Emergency Medi cal Kits.

Summary of Relief Sought: The relief would temporarily exempt passenger

- carrying air lines from

having to carry certain injectable drugs in EMK s only during acute

shortage s beyond operator control.

Granting this exemption is in the public interest as it avoids potential, unpredictable disruptions in

scheduled and unscheduled air transport service.

Reasons for E xercising the P rivileges of the R equested E xemption O utside the United States

Due to the unpredictable nature of situations in which this exemption might be triggered, and in order to

avoid disruptions in international operations

, U.S. carriers would need to be able to exercise the privileges

of this exemption outside the United States. The International Civil Aviation Organization (ICAO) st andard

calls for aircraft to be equipped with “accessible and adequate medical supplies,” and recommends that

these supplies include, for aircraft authorized to carry more than 100 passengers on a flight of more than

two hours, “a medical kit, for the use of medical doctors or other qualified persons in treating in

- flight medical

emergencies.” Additional guidance provided by ICAO recommends but does not require Atropine

, Dextrose,

and Epinephrine

. 20 Absence of Atropine

, Lidocaine, Dextrose, or Epinephrine i n an EMK on an aircraft

operating outside the U.S. therefore would not violate ICAO requirements.

18 FAA Advisory Circular AC

- 121

- 33B, 1/12/2006

19 A4A further notes that a recent FAA decision to reduce MEL relief allowing only one flight before restocking an opened EMK

instead of three flights results in many carriers purchasing and maintain ing a second EMK for each airplane , which requires

acquiring additional atropine.

20 ICAO, International Standards and Recommended Practices, Annex 6 to the Convention on International Civil Aviation (Ninth

Edition, July 2010), Part I, para. 6.2.2Conclusion

For the foregoing reasons, we respectfully request a long term exemption from the requirements of 14CFR

§ 121.803(c)(3) and Appendix A to Part 121 pertaining to the provision of

Atropine

, Dextrose, Lidocaine, and Epinephrine in the EMK during periods of commercially unavailability.

Respectfully s ubmitted Dec ember 29

, 2015 by:

Robert L. Ireland

Managing D i rector, Engineering and Maintenance

Airlines for America

George Paul

Director of Technical Services

National Air Carrier Association

1000 Wilson Boulevard

Suite 1700

Arlington, Virginia 22209

- 3928

Stacey Bechdolt,

VP, Safety & Operations and Regulatory Counse l

Regional Airline Association

2025 M Street, NW

Suite 800

W ashington, DC 20036

cc:

Mr. John Duncan

Federal Aviation Administration

Director, Flight Standards Service, AFS

- 1

800 Independence Ave., SW

Washington, DC 20591

Mr. Les Smith

Federal Aviation Administration

Flight Standards Service

Air Transport Division, AFS

- 200

800 Independence Avenue, S.W.,

Washington, DC 20591 Ms. Nancy Clau ssen

Federal Aviation Administration

Flight Standards Service

Aircraft Transport Division, AFS

- 2 00

800 Independence Avenue, S.W.,

Washington, DC 20591

Mr. Tim Shaver

Federal Aviation Administration

Flight Standards Service,

Aircraft Maintenance Division AFS

- 300

470 L’Enfant Plaza, SW

Washington, DC 20024Passenger Carrying Airline Association Members

Airlines for America National Air Carrier

Association Regional Airline Association

Alaska Airlines Air Transport International Air Wisconsin Airlines Corp.

American Airlines Allegiant Air Cape Air

Atlas Air, Inc. Atlas Air, Inc. CommutAir

Hawaiian Airlines, Inc. Eastern Airlines Compass Airlines

JetBlue Airways Corp. Everts Air Cargo Empire Airlines

Southwest Airlines Co. Kalitta Air Endeavor Air

United Airlines, Inc. Lynden Air Cargo Envoy

Air Canada (Associate Member) Miami Air International ExpressJet Airlines

National Airlines GoJet Airlines

National Air Cargo Grand Canyon Airlines/Scenic

Northern Air Cargo Great Lakes Aviation

Omni Air International Hawaii Island Air

Southern Air Horizon Air

Spirit Airlines Jazz Air

Sun Country Airlines Mesa Airlines

USA Jet Airlines New England Airlines

W estern Global Piedmont Airlines

PSA Airlines

RAVN Alaska

Republic Airlines

Seaborne Airlines

Shuttle America

Silver Airways

SkyWest Airlines

Surf Air

Trans States Airlines