February 27 , 2016

Docket Management Facility

U.S Department of Transportation

1200 New Jersey Avenue

SE West Building Ground Floor Room W12

- 140
Washington, DC 20590

Re: Petition for Exemption No. 10690, Docket No. F AA

- 2013

- 0034

Dear Sir or Madam:

In accordance with the provisions of Title 14, Code of Federal Regulations (14 CFR) §11.63 and §11.81, Peninsula Airways, Inc , petition for a limited exemption from 14 CFR §121.803(c)(3) which requires airplanes with seating capacity of more than nine pass engers to carry an Emergency Medical Kit (EMK) with contents as specified 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 avai lability of injectable drugs Atropine, Dextrose, Lidocaine, or Epinephrine, named in Part 121, Appendix A.

Background

Since 1986, large passenger

- carrying aircraft have been required to carry an EMK to assist crewmembers or other volunteers in responding to an in

- flight medical emergency. That requirement was extended in 1996 to cover 20

- 30 seat commuter aircraft. 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. 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, which currently includes all passenger

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

- go” item that must be on board for the airplane to be operated, and current Master M inimum Equipment List (MMEL) relief 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 o ne flight relief described above.

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/pr e

- 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 su rfaced with little notice. The FDA does 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 gro und

- based users to obtain these drugs. 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 Atropi ne 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, Peninsula Airways has been able to address temporary shortages through a variety of accommodations and FAA exemptions. Ordinarily, Peninsula Airways maintain s 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 arerestocked periodically since some of the medications they contain h ave a shelf

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

A lso, 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.

P revious Petitions for Exemption and Subsequent Operator Action

Airlines f or

A merica requested and w as granted s eparate ex emptions for Atropine and D extrose

on very s hort not ice i n early 2013. Peninsula Airways was i ncluded in this ex emption as a “similarly s ituated c arrier "

. Wi th subsequent ex tensions, these Exemptions c urrently ex pire on January 31, 2 016 and M arch 31, 2016 r espectively. This i s P eninsula Airways i nitial pet iti on for

this ex emption.

T he pattern established by the short

- fused Atropine and Dextrose petitions ref lect the uncertainties of information flowing from the manufacturers. 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 have unwaveringly demonstrated their responsibility to the public by placing the drugs in EMKs whenever the products have been available, even during periods of exemption.

T he lack of timely predictability of shortages, taken with the highly responsible behavior 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.

T he Applicable Regulations and Relief Sought

P eninsula Airways, Inc. seek s long

- term exemption from 14 CFR 121.803(c)(3), which requires

passenger

- carrying airplanes to be equipped with an EMK 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 appropriate labeling of the kits indicating the shortage.

R easons for se eking the relief include:

1) Suppliers cannot provide EMKs stocked with the drugs when pharmaceutical manufacturers do not deliver product and have not supplied revised fulfillment dates.

2) Replacement supplies of these substances cannot be imported from foreig n

m anufacturers.

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;

• Banyan estimates that Atropine is used less than one time per one thousand u nits

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.

• Epinephrine 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 is even more rarely used, aggregated within “other” by the footnoted NEJM study.Without the requested relief, carriers will periodically and with little notice face the decision to ground aircraft.

Therefore, we 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 Peninsula Airways to comply with section 121.803, part 121 Appendix A, and MEL requirements when shortages exi st 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 airw orthy 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 uninterrupted and in this respect would serve the public

interest.

I f you have any questions regarding this topic, please contact me immediately at (907)771

- 2569

Respectfully,

William Batman

Director of Operations

Peninsula Airways

6100 Boeing Ave

Anchorage, AK 99502

peninsula airways inc. | 6100 boeing a venue | anchorage alaska 99502

907.771.2500 | fax 907.771.2664 | info@penair.com | penair.com