### 800 West Idaho • Suite 304 • Bois e, Idaho 83702 • 208.333.XTRA (9872)

Date: 27 February 2014 Subject: Petition for Exemption 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, TEM Enterprises d/b/a Xtra Airways (AOC # BJNA472B) petition the Federal Aviation Administration (FAA) 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 specified in Appendix A to Part 121. Specifically, we request that FAA temporarily suspend for one year a requirement for air carriers to include Atropine in the EMKs of th eir aircraft during flight operations because of a manufacturing supply shortage leaving airlines without the means to comply with the requirements of Appendix A. Current Shortage of 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.” Part 121, Appendix A specifies that an EMK must include two Atropine 0.5 mg, 5 cc injectable single doses or an Atropine equivalent. Historically, our EMK vendor / repair station Majesti c Aerotech Inc. obtained Atropine from some of the four producers in the United States, Amphastar Pharmaceuticals Inc., Hospira, Inc., American Regent/Luitpold, and West-Ward Pharmaceuticals. Majestic Aerotech Inc. provided us a letter in Feb 2013 (see enclosures 3) stating there is currently a critical shortage of Atropine in the U.S. and that it will be impossible to supply EMKs with Atropine to our membe rs after January 25, 2013. This shortage is due to multiple factors, including American Regent’s decision to stop producing Atropine and Hospira’ s decision to indefinitely postpone Atropine production and the shortage continues (see enclosure 2 FDA drug shortage data). This production shortage has resulted in the two remaining suppliers, West-Ward and Amphastar rationing remaining supplies to first-line responders such as hospita ls and paramedic units. In addition, according to Banyan, there are no FDA-approved foreign Atropine manuf acturers authorized to import Atropine into the U.S. to relieve the shor tage. Also, while FDA has the authority to extend the expiration date on drugs such as Atropine, the drug manufacturer must petition the FDA with drug stability data asking for an extension, which no manufacturer has done. Fin ally, Appendix A permits carriers and suppliers to provide an Atropine equivalent, how ever, according to Majestic Aerotech Inc. there is no equivalent substitute for Atropine. To date, we have been able to address temporary shortages through a variety of accommodations. We have depleted our spare 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. During this shortage, EMKs in which Atropine has been used or has expired cannot be refurbished and returned to use, leaving TEM Enterprises without the means to comply with the requirements of Appendix A. The Applicable Regulations and Relief Sought We seek exemption from 14 CFR 121.803(c)(3), which requires passenger-carrying airplanes to be equipped with an EMK containing two single Atropine doses as specified in part 121 Appendix A, EMK requirements, paragraph 2. Reasons for seeking the relief include:

### 800 West Idaho • Suite 304 • Bois e, Idaho 83702 • 208.333.XTRA (9872) 1) Suppliers cannot provide EMKs stocked with Atropine because recent pharmaceutical manufacturing changes have reduced the availability of Atropine (also referred to as Atropine Sulfate) and manufacturers have not supplied revised fulfillment dates; 2) Replacement supplies of Atropine cannot be imported from foreign manufacturers 3) There is no accepted substitute for Atropine 4) Primary kit vendor / repair station Majestic Aerotech Inc. reports it has already depleted its Atropine supply Without the requested relief we will face the decision to ground aircraft. Therefore, we request relief from the requirement to carry Atropine in an EMK for a period of one year from the date of granting this petition. Request for Interim Relief The exemption process is likely to take more than tw o weeks to complete and therefore we also request that FAA expedite this petition and in the interim use its discretion to not enforce the requirement to carry Atropine in Emergency Medical Kits or use any other means to provide interim relief, until the agency is able to answer this petition. Granting the Exemption Would be in the Public Interest Absent this relief, there is no means for us to comply with section 121.803, part 121 Appendix A, and MEL requirements when Atropine needs 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 otherw ise 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 uninterrupted and in this respect would serve the public interest. A Summary of this Petition that FAA Could Publish in the Federal Register Petitioners: TEM Enterprises 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 Atropine in EMKs due to a chronic shortage of the drug Granting this exemption is in the public interest as it avoids potential, unpredictable disruptions in air transport service. Reasons for Exercising the Privileges of the Re quested Exemption Outside the United States. Due to the unpredictable nature of situations in which this exemption might be triggered, in order to avoid disruptions in international operations TEM Enterprises 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 an d 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 – injectable”.19 Absence of Atropine in an EMK on an aircraft operating outside the U.S. therefore would not violate ICAO requirements.

### 800 West Idaho • Suite 304 • Bois e, Idaho 83702 • 208.333.XTRA (9872)

Conclusion For the foregoing reasons, we respectfully request an expedited exemption from the requirements of 14 C.F.R. § 121.803(c)(3) and Appendix A to Part 121 pertaining to the provision of Atropine in the EMK for one year or until Atropine is once again commercially available.

Respectfully,

Marvin Morrill Director of Maintenance TEM Enterprises 805 West Idaho Street Suite 400 Howard Puckett Chief Inspector TEM Enterprises 805 West Idaho Street Suite 400 Boise, ID 8370 Boise, ID 8370



### Enclosures/