# ' america

Submitted via www.regulations.gov
Federal Aviation Administration U.S. Department ofTransportation Docket Operations West Building Ground Floor, Room W12-140 1200 New Jersey Avenue, SE Washington, D.C. 20590 March 7, 2016 555 Airport Blvd., Ste. 500 Burlingame, CA 94010 650-762-7108 john

. ,ark\ ({ t virginamerica.com



### Re Petition for Amendment to Exemption No. 10690E Regulatory Docket No. FAA-2015-0409/ FAA-2013-0034
Ladies and Gentlemen: Virgin America Inc. ("Virgin America"), a part 121 passenger carrying operator, hereby petitions for an amendment to FAA Exemption No. 1 0690E, which currently grants a long-term exemption to members ofAirlines for America (A4A), the Regional Airlines Association (RAA), and the National Air Carriers Association (NACA) from certain requirements of 14 C.F.R. 

### § 121.803(c)(3) regarding emergency medical kits (EMK). The requested amendment will add Virgin America to the carriers covered by Exemption No

. 1 0690E. The exemption specifically applies to the required contents ofthe EMKs during temporary supply shortages ofthe drugs Atropine, Dextrose, Epinephrine and/or Lidocaine. Currently Virgin America is covered under the following exemptions regarding the required contents ofon-board EMKs: (i) Exemption No. 10721 A concerning the carriage ofone single dose ampule ofDextrose 50 cc injectable, which is scheduled to expire on March 16, 2016 and (ii) Exemption No. 1660D concerning the carriage of two single dose ampules ofAtropine 5 cc injectable, which is scheduled to expire on March 31, 2016. Virgin America further requests that the FAA expedite action on Virgin America's petition 1 and that, until such time as it acts on this petition, exercise its discretion not to enforce the regulations that are the subject ofthe reliefrequested herein.

1 Virgin America respectfully requests a waiver from 14 C.F.R

. § 11.63(d), requiring any petition for an exemption

to be submitted 120 days before the requested effective date

.Applicable Regulation and Request for Amendment ofExemption No. 1 0690E Virgin America requests an amendment to the long-term exemption granted by FAA in the Order Granting Exemption No. 1 0690E, issued January 29, 2016 ("Exemption Order"). Exemption 10690E granted A4A, RAA, and NACA members a long-term exemption from 14 C

.F.R. § 121 .803(c)(3), which requires passenger-carrying airplanes to be equipped with an EMK containing certain drugs including Atropine, Dextrose, Lidocaine, or Epinephrine in amounts as specified in Appendix A to Part 121. The exemption applies during periods ofshortage, not due to operator fault, ofthe listed substances. In the Exemption Order, the FAA advised that carriers previously covered under Exemption No. 1 0690D as "similarly-situated air carriers" would no longer be afforded the benefit ofsuch coverage and would need to apply sepa rately for relief similar to that granted to the member airlines ofA4A, RAA and NACA with respect to the required contents of EMKs. Under the procedures established in the Exemption Order, any carrier that is not a member or associate member ofA4A, RAA or NACA may obtain this coverage by petitioning for similar relief , following which the FAA will amend Exemption No. 1 0690E to add the name ofthe petitioning carrier. Virgin America faces the same problems as the members ofA4A, RAA, and NACA in obtaining Atropine, Dext rose, Epinephrine, and Lidocaine in the amounts required in part 121

. As more fully described in A4A's petition ofDecember 29, 2015, and acknowledged by the FAA in the Exemption Order, national shortages ofAtropine, Dextrose, Epinephrine, and Lidocaine can occur with little advance notice

. Also, the duration ofsuch notices can vary, making planning for the refurbishing ofEMKs virtually impossible during a shortage. Due to the fact that the distributors ofthe EMK-required pharmaceuticals to airlines also compete with hospitals and first responders for access to the drugs, during periods ofnationwide shortages, it is even less likely that the suppliers ofthe EMKs would be able to supply orrefurbish EMKs in order to be fully compliant with 14 C.F.R. § 121.803(c) which could cause Virgin America to ground flights
as EMKs are considered a "no-go" item on the Master Minimum Equipment List (MMEL). Moreover, during these shortages, there are no alternative means to comply with the requirements as a carrier cannot obtain the required drugs from foreign sources. As determined by the FAA in the Exemption Order, granting the exemption for Virgin America would be in the public interest and would not adversely affect safety, due to the fact that the drugs are very rarely used in-flight. Virgin America respectfully requests that the FAA, in considering this petition to amend the Exemption Order, take notice ofall information included with the A4A Exemption Request in Regulatory Docket No. FAA-2013-0034. Virgin America's reasons for seeking the reliefinclude the reasons outlined in the A4A petition: (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 ofthese substances cannot be imported from foreign manufacturers.



### 2

### (3) There is no accepted substitute for Atropine, and where substitutes for other drugs may exist, their supplies are no more dependable than the supplies for the required drugs. (4) These drugs are rarely used

. (5) Due to the need to resupply and refurbish the supply ofEMKs with unexpired Atropine, Dextrose, Epinephrine, Lidocaine, carriers cannot adequately plan for such shortages, which in tum can disrupt service

. Summary of Specific ReliefRequested
For the foregoing reasons, Virgin America requests the following specific relief: (1) That the FAA grant an amendment to Exemption No. 1 0690E relieving Virgin America from the requirement of 14 CFR § 

### 121.803(c)(3) to the extent necessary to allow aircraft to be operated without meeting the requirements ofAppendix A to part 121 regarding emergency medical kit (EMK) required contents Atropine, Dextrose, Epinephrine and/or Lidocaine due to shortages ofthose drugs resulting from uncontrollable supply deficit; and, (2) That the FAA exercise its discretion not to enforce the regulations that are the subject ofthe reliefrequested herein until it acts on this exemption renewal request. Virgin America is requesting that the exemption be valid for the period March 16, 2016 to January 31, 2020. This is the same long term reliefgranted to other similarly situated carriers represented by A4A, RAA, and NACA. Virgin America is willing to accept the conditions placed on the exemption as outlined in the Exemption Order. Granting ofthe Exemption Amendment Would Be in the Public Interest
Without the reliefrequested herein, it is not possible for Virgin America to comply with the requirement under 14 C.F

.R

. § 

### 121

.803(c)(3) and part 12 1, Appendix A with respect to the carriage ofon-board EMKs containing Atropine, Dextrose, Epinephrine and Lidocaine. As a consequence, unless the reliefis granted, Virgin America would have no choice but to remove the aircraft from passenger-carrying operations pending procurement ofthe required pharmaceutical supplies. Grant ofthe reliefrequested herein would allow the continuation of uninterrupted, critical air service, and therefore, would be in the public interest. Granting the Exemption Amendment Would Not Adversely Affect Safety
As explained in the Exemption Order, the usage ofthe EMK-required drugs at issue is extremely uncommon. As reported by the chiefdistributors ofthese drugs to airlines, in most cases the need for re-supply occurs chiefly because ofexpiration ofthe specified shelf-life, rather than administration to passengers. The case-by-case exemption from the EMK requirement for these drugs during acute shortages would not adversely affect the safety ofthe traveling public because they are used so infrequently

.

3

### Reasons for Exercising the Privileges ofthe Requested Exemption Outside the United States Virgin America will be required to exercise the privileges ofthe requested exemption outside the United States, given that its aircraft with onboard EMKs are routinely rotated between domestic and international passenger-carrying operations. While the International Civil Aviation Organization (" ICAO") recommends a medical kit equipped with "accessible and adequate medical supplies" for the type ofinternational flights conducted by Virgin America, ICAO recommends, but does not require, that such medical kits contain Atropine, Dextrose and Epinephrine

. As a result, the absence ofthese drugs in an EMK on an aircraft operating outside the U.S. would not violate ICAO requirements

. As extending Exemption 1 0690E to Virgin America is not controversial and will not establish any precedent, Virgin America submits that good cause exists to waive publication ofthis petition in the Federal Register before the FAA acts on this request. Delaying action on this request would adversely affect Virgin America due to the imminent effect on operations that would be caused by possible shortages ofAtropine, Dextrose, Epinephrine or Lidocaine.

4 Respectfully submitted, 

# f**~** 

# 'Ya4-y lf:'j!,.**P~•<ro.J** John Varley Senior Vice President & 

### General Counsel