Febhruary 25, 2017

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 10690E Reference: Emergency Medical Equipment; 14 CFR121.803.

Dear Sir or Madam: In accordance with the provisions of Title 14, Code of Federal Regulations (14 CFR) §11.63 and §11.81, Eastern Air lines petition for a limi ted 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 specified in Appendix A to Part 121. Specifically, we request that FAA issue a lon g

- term exemption for use during periods of temporary supply shortages, beyond operator control, affecting availability of injectable drugs Atropine, Dextrose, Lidocaine, or Epinephrine, named in Part 121, Appendix A.

Background Since 1986, large passeng er

- carrying aircraft have been required to carry an 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 airlines to augment their EMKs and include Atropine, Dextrose, Lidocaine, and Epinephrine. 3 The regulatory provisi on 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 which currently includes all passenger

- carrying aircraft having a seating capacity of more than nine passenger s. 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) relief requires a carrier to repair or replace an EMK within one flight of an incomplete, missing or inoperati ve EMK; there is no MEL relief permitting a carrier to depart with an EMK missing any specified contents beyond the one flight relief described above. 7

1 Emergency Medical Equipment Requirements Rule, 51 Fed. Reg. 1218 (Jan. 9, 1986). 2 60 Fed. Reg. 6583 1 (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.”

Shortages occur due to multiple factors including overall non

- aviation demand and manufacturing shortfalls, 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 doesnot 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 d rugs. Hospitals and first responders use the substances more often than they discard it through expiration (as usually occurs in aviation). For example, Banyan reported that during 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 suppliers 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 t o 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, Dextrose, Lidocaine, or Epinep hrine 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 carriers and suppliers to provide equivalent substances, however, according 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 March 31, 2016 respectively. A petition was submitted in 2010 regarding Epinephrine was withdrawn as supply

recovered.

8 Exemption 1 0690, issued January 25, 2013 and Exemption 10721, issued March 14, 2013. The pattern established by the short

- fused Atropine and Dextrose petitions, and the aborted Epinephrine petition, reflect the uncertainties of information flowing from the manufactu rers. For apparently commercial reasons, shortage durations vary widely and are not communicated 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 ha ve unwaveringly demonstrated their responsibility to the public by placing the drugs in EMKs whenever the products have been available, even during periods of exemption. The lack of timely predictability of shortages, taken with the highly responsible beh avior of kit suppliers and operators, together underscore the appropriateness of a long

- term Exemption that will be used only when supplies are impaired beyond their control.Current Shortages

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 used 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 doses or an Atropine equival ent.

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 al so 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

1 3 65 FR 33726; FAA Advisory Circular AC

- 121

- 33B

14 FDA website Major EMK airline suppliers and refurbishers MedAire, Inc. and Banyan International Corporation, obtain Atropine from four producers in the United States, Amphastar Pharmaceuticals Inc., Hosp ira, Inc., American Regent/Luitpold, and West

- Ward Pharmaceuticals. 10 In Banyan’s letter that accompanied the first petition addressing Atropine, they pointed out that there are no FDA

- approved foreign Atropine manufacturers authorized to import Atropine into the U.S. to relieve the shortage.

Dextrose

Dextrose, a required 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. Major EMK airline suppliers and refurbishers MedAire, Inc. and Banyan International Corporation, obtained Dextrose from two producers in the United States, Amphastar Pharmaceuticals Inc. and Hospira, Inc. 12 Appendix A permits carriers and su ppliers to provide a Dextrose equivalent and MedAire 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 al ternative drugs is also unpredictable. Epinephrine

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 amp ules and two 1:10,000, 2cc single dose ampules of Epinephrine or respective equivalents. Major EMK airline suppliers and refurbishers MedAire, Inc. and Banyan International Corporation, obtain Epinephrine from four producers in the United States, Amphasta r 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 unresponsiveness to defibrillation and possibly for main tenance of normal heart rhythm after successfuldefibrillation”. 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.

15 65 FR 33726; FAA Advisory Circular AC

- 121

- 33B

1 6 FDA website

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

- First Aid Kits and Emergency

Medical Kits. Summary of Relief Sought: The relief would temporarily exempt passenger

- carrying airlines from having to carry

cer tain injectable drugs in EMKs only during acute shortages 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 Exerci sing the Privileges of the Requested Exemption Outside 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) standard calls for aircraft to be equipped with “accessible and adequate medical supplies,” and recommends that these suppl ies 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 in an EMK on an aircraft operating outside the U.S. therefore would not violate ICAO requirements.

John Furneaux

VP F light Operations Eastern Air Linnes

4200 NW 36 th Street Bldg 5A Miami, Florida 33166Summary

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.