# amer1ca

Submitted via www.regulations.gov Federal Aviation Administration U.S. Department ofTransportation Docket Operations February 28, 2013

West Building Ground Floor, Room W12-140 1200 NewJersey Avenue, SE Washington, DC 20590 Re: Petition for Exemption; 14 C.F.R. § 121.803 Ladies and Gentlemen: Pursuant to 14 C.F.R. §§ 11.63 and 11.81, Virgin America Inc. ("Virgin America"), apart 121 passenger-carrying operator, respectfully petitions for an exemption from 14 C.F.R. 121.803(c)(3) and part 121, Appendix A, to relieve Virgin America for a period ofone year from the requirement to carry Dextrose in on board Emergency Medical Kits ("EMKs"), as more fully described herein. Virgin America asks thatthe FAA, in considering this request, take notice ofa petition submitted byAirlines for America, the National Air CarrierAssociation and the Regional Airline Association to the FAA on February 26,2013, in DocketFAA-2013-0201, seeking similar relief("Association Petition"). Virgin America further asks thatthe FAA expedite this Petition1and, until such time as it acts on this Petition, exercise its discretion not to enforce the regulations that are the subject ofthe reliefrequested herein. By letter dated February 21, 2013, MedAire, Inc. ("MedAire"), Virgin America's supplier of EMKs, notified air carriers that it had depleted its supply ofDextrose 50%/50 cc injectable due to a national pharmaceutical production shortage, and, as a consequence, would only be able to refurbish used and expired EMKs which still contain Dextrose that has not yet expired. A copy ofthe letter is included with this Petition as Attachment A. The national Dextrose shortage has been widely documented. Dextrose 50%/50 mL injectable is listed on the Food and Drug Administration's ("FDA") Cun·ent Drug Shortages list? Similarly,

2 Accordingly, Virgin Americarespectfully requests a waiver from 14 C.F.R. § 11.63(d), requiring any petition for an exemptionto be submitted 120 days before the requested effective date. See Www

.fda.gov/Drugs/DrugSafety/DrugShortages

. The FDA lastrevised or re-verified these entries in February of2013.Federal Aviation Administration February 28, 2013 Page 2

the American Society ofHealth-System Pharmacists ("ASHP") lists Dextrose 50%/50 mL injectable onits online Drug Shortages Resource Center. 3 Both the FDA and ASHP lists state thatthe acute national shortage is the result ofincreased demand. This national shortage extends to Dextrose 25% as well.4 Virgin America understands that there are, at present, only two Dextrose pharmaceutical manufacturers authorized to supply the U.S. market-Hospira, Inc

. and Amphastar Pharmaceuticals, Inc.
As recounted in the MedAire letter, pharmaceutical manufactures ofDextrose have indicated that they planto resume distribution ofthe drug shortly. However, these manufacturers do not anticipate that availability will be able to meet the national demand for Dextrose until sometime during the second calendar quarter of2013. Furthermore, as MedAire advises in the letter, "once distribution begins again, distribution is at the discretion ofthe manufacturer. Thetypical distribution will be to first line medical facilities and emergency response units and finally to suppliers such as MedAire. To that end, [MedAire] anticipate[s] that this shortage may extend to the end ofQ22013 or longer." Attachment A at 2 (emphasis added). Significantly, MedAire also observes in its letter that, based on a recent review ofin-flightmedical cases, fewer than 0.02% ofsuch cases were serious enough to warrant the use ofDextrose or Glucogan- a drug that is reported to achieve similarresults in certain passengers experiencing severe hypoglycemia, but is not identical to Dextrose.5 · As a direct result ofthe acute national Dextrose shortage, Virgin America's onboard EMKs for which Dextrose has been depleted orexpired cannotpresently be refurbished and returnedto service. Under such circumstances, Virgin Americawill not have a means to comply withthe requirements of 14 C.P.R. 121.803(c)(3) and part 121, Appendix A. Thus, Virgin America is compelled to seek an exemption from the applicable regulations, as set forth below

. The Specific Regulation from Which an Exemption is Sought (14 C.F.R. § 11.81(b)) Virgin Americapetitions the FAA for an exemption from 14 C.P.R. 121.803(c)(3), requiring passenger-carrying airplanes to be equipped with anEMK containing Dextrose in the manner prescribed atpart 121, Appendix A, EMKrequirements, paragraph 2 when, due to the national shortage described herein, Virgin America is unable to procure such Dextrose for its onboard EMKs

. Virgin America also asks that the FAA allowthe use ofDextrose 25% injectable in two doses or Glucagon 1mgkit (dry powder and water reconstitutionkit) as acceptable substitutes during the requested exemptionperiod, to the extent that Virgin America is able to procure such

3 4

5 See www.ashp

.org/menu/DrugShortages

. Ibid. Virgin America understands that Hospira, Inc., is the sole supplier ofDextrose 25% synnges. This rate is similar to thatprovided by another EMK supplier, Banyan International Corp. See Association Petition, Enclosure 2 (estimating that Dextrose is used in less than 0.4% of inflight emergencies).Federal Aviation Administration February 28, 2013 Page 3

substitutes for its onboard EMKs. 6 Finally, Virgin America requests thatthe FAA, in permitting the exercise ofthe privileges conferred by the exemption, notrequire a pilot-in-command preflight briefing regarding Dextrose and instead require Virgin America and otherpart 119 certificate holders conducting part 121 passenger-carrying operations to inform the flight crew. In this regard, the FAA could require such operators to provide a bulletin to flight attendants, as proposed in the Association Petition. Id at 3. Regardless, Virgin America submits that its flight attendants, due to mandatory pre-flight inspections and EMKlabeling provided by suppliers, will know whetherthe EMK contains Dextrose. The Extent ofand Reasons for the Requested Relief(14 C.F.R. § 11.81(c)) Virgin America requests an exemption from 14 C.F.R. 121.803(c)(3) and part 121, Appendix A, only to the extent necessary to relieve Virgin America from the requirementto carry one single dose ampule ofDextrose, 50%/50 cc injectable inrequired on board EMKs, when, due to the nationwide shortage described herein, Virgin America is unable to procure such Dextrose for its onboard EMKs. Virgin America submits that good cause exists for the FAA to expedite, and waive publication of a summary of, this Petition before acting onthe request. Moreover, until suchtime as the FAA acts onthis Petition, Virgin America asks that the FAA exercise its discretion not to enforce the regulations that are the subject ofthe reliefrequested herein. In support ofthis requested relief, Virgin America submits thatthe national Dextrose shortage has significantly increased the likelihood that many passenger-carrying aircraft will be unable to meet the requirements ofpart 121, Appendix A. As set forth above, this shortage has been documented by boththe FDA and the ASHP. As set forth inthe attached letter, Virgin America's EMK supplier is unable to replenish Dextrose whenproviding new orrefurbished on board EMKs to Virgin America due to this acute shortage. Moreover, it is reasonably expected that Dextrose availability will not be able to meet demand until the second calendar quarter of 2013. Finally, even upon a resumption ofdistribution by pharmaceutical manufacturers, distribution may be rationed to assign priority to first line medical facilities and emergency response units, as is often the case during recovery periods following national drug shortages, raising the likelihood that EMK suppliers will not be in aposition to supply Dextrose to air carriers until after the second calendar quarter of2013. Granting ofthe Exemption Would Be in the Public Interest and Benefit the Public as a Whole (14 C.F.R. § 11.81(d)) Without the reliefrequested herein, it is not possible for Virgin Americato comply withthe

6 According to MedAire and as set forth above, the national shortage currently extends to Dextrose 25%. See Attachment A at 2. The availability ofGlucagon 1mg kit as a substitute is unknown at this time.Federal Aviation Administration February 28, 2013 Page4

requirement under 14 C.F.R. 121.803(c)(3) and part 121, Appendix A, with respect to Dextrose in onboard EMKs.7 As a consequence, unless the reliefis granted, Virgin Americawould have no choice but to remove aircraft from passenger-carrying operations pendingprocurement of additional Dextrose supplies

. Grant ofthe reliefrequested herein would allowthe continuation ofuninterrupted, critical air service, and, therefore, would be in the public interest. Furthermore, given that a rationing system may be implemented for Dextrose, whereby preference is assigned to front-line responders such as hospitals andparamedic units, continuing to require Virgin America and similarly-situated air carriers to comply withthe requirementto include Dextrose in EMKs during this critical period ofnational shortage would be contraryto the national interest, as doing so would place air carriers in competition withthe more immediate and compelling needs ofground-based medical providers. Finally, grant ofthis Petition would be consistent withrecently-issued FAA limited exemptions from the requirements of 14 C.F.R. 121.803(c)(3) and part 121, Appendix A, inresponse to a nationwide shortage ofAtropine, another drug required to be included in the on board EMKs of part 119 certificate holders conductingpart 121 passenger-carrying operations. See FAA ExemptionNos. 10690 (issued Jan. 25, 2013) and 10702 (issued Feb. 15, 2013). There, under remarkably similar circumstances, the FAA quite properly found: The documented Atropine shortage creates the possibilitythat a significant number of aircraft would not be able to meet the requirements ofAppendix A ofpart 121 and would have to be taken out ofservice

... EMK suppliers report that Atropine is predominantly replaced in EMKs due to expiration. Accordingly, the FAA has determined thatthe impact on large numbers ofpassengers that would be caused by grounding these aircraft for lack ofAtropine outweighs the benefit ofhaving the medication, which reportedly is infrequently used in response to onboard medical events. Further

...the nationwide Atropine shortage is affecting not only EMK suppliers to airlines, but also ground-based medical service providers. The FAA also finds that, because this medication is reported to rarely be used in flight, it is not inthe public interest for EMK suppliers to airlines to be competing with the greater need and demand ofground-based medical providers for these medications. ExemptionNo. 10690 at 3.

7 Under FAApolicy standardizing Master Minimum Equipment List ("MMEL") requirements for the deferral ofapproved emergency medical equipment, including EMKs,the continued operation ofan aircraft with an incomplete EMK is only authorized for a maximum ofone flight to a location where repairs or replacements canbe made. See FAA MMEL Policy Letter (PL) 73, Revision 5 (Jun. 15, 2011).Federal Aviation Administration February 28, 2013 Page 5

Granting ofthe Exemption Would Not Adversely Affect Safety (14 C.F.R. § 11.81(e)) As set forth in the attached MedAire letter, the usage ofDextrose during onboard medical events is extraordinarily uncommon. Moreover, in Virgin America's experience, and as confirmed in our discussions with MedAire, when Dextrose is replaced in EMKs, thepredominantreason is expiration -notthe depletion ofDextrose in connection with onboard medical events. Thus, exempting Virgin America would not adversely impact the safety ofthe traveling public.

Suitable Summary for Publication in the Federal Register (14 C.F.R. § 11.81(e))8 Petitioner Regulation from which exemption sought:

Nature ofrequested exemption: Virgin America Inc. 14 C.F.R. 121.803(c)(3) andpart 121, Appendix A - First Aid Kits and Emergency Medical Kits The requested reliefwould temporarily exempt, for one year, the petitioner from the requirement to include Dextrose in its onboard emergency medical kits when, due to a nationwide shortage ofthe drug, it is unable to procure this item for such kits.
Reasons Why the Privileges Need to be Exercised Outside the U.S. (14 C.F.R. § 11.81(g)) Virgin America will be required to exercise the privileges ofthe requested exemption outside the United States, giventhat its aircraft with onboard EMKs are routinely rotated between domestic and international passenger-carrying operations. Guidance provided by the International Civil Aviation Organization (ICAO) recommends but does not require "Dextrose 50% (or equivalent) -injectable: 50 ml" in EMKs

. As a consequence, grant ofthe reliefrequested herein would not be contrary to ICAO requirements. Conclusion Based on the foregoing, Virgin America respectfully requests an exemption from 14 C.F.R. 121.803(c)(3) and part 121, Appendix A, to the extent necessary to relieve Virgin America, for a period ofone year, from the requirement to carry one single dose ampule ofDextrose 50%/50 cc injectable in on board EMKs, when, due to the nationwide shortage described herein, Virgin America is unable to procure such Dextrose for its on board EMKs. Virgin America further

8 As previously noted, Virgin America is seeking a waiver ofthe advance publication requirement due to the urgent nature ofthe reliefrequested.Federal Aviation Administration February 28, 2013 Page6

requests thatthe FAA grant such additional or other reliefas the FAA may deem necessary or appropriate. Finally, Virgin America asks that the FAA expedite this Petition and, until such time as it acts on the Petition, exercise its discretion notto enforce the regulations that are the subject ofthe reliefrequested herein. Respectfully submitted,

# ~;~**~::J** General Counsel Virgin America Inc. 555 Airport Boulevard, Suite 500 Burlingame, CA 94010 (650) 762-7108 john

. varley@virginamerica.comFederal Aviation Administration February 28, 2013 Page 7

cc: 

### Mr. John Allen Federal Aviation Administration Director, Flight Standards Service, AFS-1 800 Independence Avenue, SW Washington, DC 20591 john.allen@faa.gov 

### Mr. John Duncan Federal Aviation Administration Deputy Director for Policy, Flight Standards, AFS-2P 800 Independence Avenue, SW Washington, DC 20591 john.s.duncan@faa.gov 

### Mr. Les Smith Federal Aviation Administration Flight Standards Service Air Transport Division, AFS-200 800 Independence Avenue, SW Washington, DC 20591 leslie.smith@faa.gov Mr. Steve Douglas Federal Aviation Administration Flight Standards Service Aircraft Maintenance Division, AFS-300 470 L'Enfant Plaza, SW Washington, DC 20024 steven.w.douglas@faa.gov

# [Attachment A)**~** 

# MedAire e An International SOS Company February 21, 2013

Dear Sir or Madame, MedAire produces FAR-compliant medical kits for your airline subject to Part 121 requirements. Recent pharmaceutical manufacturing changes have reduced the availability of Dextrose

. Dextrose 50%, inj. 50 ml is an FAA-required component for onboard medical kits according to 14 CFR Part 121.803, Appendix A. As of February 20, MedAire has depleted its supply of Dextrose. Should your carrier request new medical kits, or request refurbishment of existing medical kits with expired or missing Dextrose, MedAire will be unable to provide FAR-compliant kits. Beginning today, we are coordinating with your carrier to re-furbish only those used and expired medical kits which still contain Dextrose that has not yet expired. In these cases, the kits will be usable for only the period oftime in which the existing Dextrose is usable-dating that varies from 1 to 11 months. For kits containing expired Dextrose, we are not able to refurbish them at this time. The manufacturers have indicated that they will begin distributing the drug again sometime in February and anticipate that availability will meet demand sometime in 02 2013. This timeline is dynamic, however, and once distribution begins again, distribution is at the discretion of the manufacturer. The typical distribution will be to first line medical facilities and emergency response units and finally to suppliers such as MedAire

. To that end , we anticipate that this shortage may extend to the end of 02 2013 or longer

. For additional information about the Dextrose production shortage, please refer to the following links: http://www

.fda

.gov/Drugs/DrugSafety/DrugShortages/ucm314739

.htm#dextrose http://www

.ashp.org/DrugShortages/Current/bulletin

.aspx?id=988

1250WestWashington Street, S uite 442 

### I Tempe, Arizona, USA 85281 Tel:+ 1480333 3700 

### I Fax: +1480333 3592

--- --**-~~----~~~~-~--~-~~~~--~----~~** -- www.medaire.com Americas • Asia Pacific, Middle East, Africa • Europe .,_ EXPERT CARE, EVERYWHERE.'M

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# MedAire**~** An International SOS Company Based on a formal review by MedAire's Medical Equipment Review Board, there are two acceptable equivalent medications for the Dextrose 50%/50 cc (single dose ampule or equivalent) requirement:

• Glucagon 1mg-- Although not an identical product, glucagon 1 mg will achieve similar results in the majority ofthe population by raising the blood glucose levels in passengers with severe hypoglycemia. • Dextrose 25% [2 doses]. Note: There is also currently 

### a shortage ofDextrose 25%.

. MedAire supports airlines with in-flight medical advisory services, assisting with approximately 25,000 events each year. A recent review of data from 2012 suggests that .02% of in-flight cases were serious enough to call for use of Glucagon [which some airlines stock] or Dextrose-- the necessary intervention to manage the medical emergency. It should be noted that these drugs are indicated in cases of severe hypoglycemia which although uncommon could be life-threatening. Please let us know ifwe can provide any additional information. Sincerely,

Heidi MacFarlane Vice President , Strategic Development MedAire, an International SOS company 

# C)J

___ _ Paulo Alves, MD, MSc, FAsMA Vice President, Aviation and Maritime Health MedAire, an International SOS company



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