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Brian E. Foont, Esq. Admitted in NY, VA, MD and DC

March 12, 2013

VIA ELECTRONIC SUBMISSION

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 Emergency Exemption from Inclusion of Dextrose in Emergency

Medical Kit (14 C.F.R. § 121.803 (c)(3) / 14 C.F.R. Part 121, App. A )

Dear Sir or Madam:

Pursuant to 14 C.F.R. §§ 11.63, 11.81, and 11.87, Frontier Airlines, Inc. (“Frontier”)

, petiti ons for expedited and emergency approval of a limited exemption from 14 C

. F

. R

. § 121.803(c)(3) . That regulation requires airlines operating pursuant to authority under 14 C.F.R. Part 119 and, therefore, under the operating requirements of 14 C.F.R. Part 121

, to carry equipment specified in Appendix A to Part 121. Among the items required is an emergency medical kit (“EMK”) that includes “ Dextrose, 50%/50 cc injectable, (single dose ampule or equivalent) ” (“Dextrose”). Frontier respectfully requests a temp ora ry,

one

- year exemption from that latter requirement to carry Dextrose in its EMKs

. Frontier makes this request because of a severe nationwide shortage of Dextrose . This shortage has been documented by and is being monitore d by the U.S. Food and Drug Administration (“FDA”). 1 Because of this, Frontier has been advised by its EMK provider

, Banyan International Corporation ( “ Banyan ” )

, that it is no longer able to acquire and, therefore, provide Dextrose in EMKs

. 2 Thus, Frontier cannot reliably determine when Dextrose will again be dependably available for the restocking of its EMKs. Banyan does note in its letter that the use of Dextrose inflight is quite rare with use in less than 0.4% of all inflight emergen c ies over the past fifteen years. We are aware that other airlines have applied for similar exemptions and have proposed to be allowed to substitute Glucagon 1mg for Dextrose as a condition of the exem p tion, on a per missive basis

, or as an alter n ative to an outright exemption

. 3 Banyan, however, has informed Frontier that it cannot provide Glucagon. Frontier, therefore, asks for an exemption without a require ment to substitute a different d rug or, in the alternative, to be permitted to substitute Glucagon for Dextrose should it become

a vailable from our supplier

.

1 See http://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm314739.htm#dextrose (extract enclosed)

. 2 See enclosed copy of memorandum from Banyan International Corporation dated March 1 2

, 2013.
3 See, e.g. , Application of Mesa Airlines, Docket FAA

- 2013

- 0200 (seeking permission to substitute Glucagon for Dextrose ) ; Application of Airlines for America/The Regional Airline Association/National Air Car rier Association

, Docket FAA

- 2013

- 0201 and Applicatio n of V irgin America, Docket FAA

- 2013

- 0224 (see king permissive, but not required, substitution of Gluc a g o n ) ; and Applicat ion of Spirit Airlines, Docket FAA

- 2013

- 0199 (seeking permission to substitute Glucagon as alternative to exemption)

.

### Petition for Emergency Exemption from Inclusion of Dextrose in Emergency Medical Kit

M arch 12 , 2013 Page 2 of 3

We respectfully note that a sim ilar exemption was sought for the then members of Airlines f or America (then the Air Transport Association of America) , the National Air Carrier Association, and the Regional Airline Association in August 10, 2 010 (Docket No. FAA

- 2010

- 0832)

. 4 That request was, however, withdrawn on November 10, 2010 because supplies had been restored. Frontier also respectfully requests that it be allowed to exercise the exception requested above outside of the United States. In that regard, we note that while the International Civil Aviation Organization (“ICAO”) recommends that “Dextrose 50% (or equivalent)

– injectable: 50 ml” be included in EMKs, it is not a requirement. 5 Thus, Frontier will not violate ICAO rules by not having Dextrose in it EMKs in its international operations. Given the urgency of this matter, p ursuant to 14 C

. F

. R

. § 11.87 and, in particular, 14 C.F.R. § 11.87 (c) in that delay would adversely impact Frontier

, Frontier requests that the FAA waive publication and immediately act on this exemption request. We respectfully further note that, because the request discussed above under Docket No. FAA

- 2010

- 0832 was published in the Federal Register for comment, 6 the public has, in fact, had an opportunity to comment on this issue. Pursuant to 14 C.F. R. § 11.81(f) we offer the following s ummary of this p etition:

Petitioner: Frontier Airlines, Inc. (“ Frontier ”)

Rule 14 C.F.R. § 121.803(c)(3) and 14 C.F.R. Part 121, App. A as

applicable to the inclusion of Dextrose, 50%/50 cc injectable, (single dose ampule or equivalent) in emergency medical kits Exemption Sought Temporarily exempt Frontier from having to carry Dextrose,

50%/50 cc injectable, (single dose ampule or equivalent) in
emergency me dical kits due to a chronic shortage of that drug

.

Respectfully submitted

,

Brian E. Foont Counsel for Frontier Airlines, Inc.

4 T hat request also sought an exemption with respect to Epinephrine 1:10,00 0, 2 cc, injectable, (single dose ampule or equivalent), which is not at issue in the present case
5 ICAO, International Standards and Recommended Practices, Annex 6 to the Convention on International Civil Aviation (Ninth Ed., July 2010), Attachment B supplementary to Chapter 6.
6 75 Fed. Reg. 51,525 (Aug. 20, 2010).

### Petition for Emergency Exemption from Inclusion of Dextrose in Emergency Medical Kit

M arch 12 , 2013 Page 3 of 3

cc: Mr. John Allen Director, Flight Standards Service, AFS

- 1 Federal Aviation Administration 800 Independence Avenue , SW Washington, DC 20591

Mr. John Duncan Deputy Director for Policy, Flight Standards, AFS

- 2P Federal Aviation Administration 800 Independence Ave nue , SW Washington, DC 20591

Mr. Les Smith Federal Aviation Administration Flight Standards Service Air Transport Division, AFS

- 200 800 Independence Avenue, SW Washington, DC 20591

Mr. Steve Douglas Federal Aviation Administration Flight Standards Service Aircraft Maintenance Division, AFS

- 300 470 L’Enfant Plaza, SW Washington, DC 20024

Mr. Douglas W. Diehl Director of Safety Frontier Airl ines, Inc. 7001 Tower Road Denver, CO 80249

Enclosures

### From http://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm314739.htm#dextrose

(reformatted)

Dextrose Injection (Initial posting

– 5/23/2012)

Company Product Availability and Estimated Shortage Duration Related

Information Shortage

Reason (per New Legislation

FDASIA)* Date

Updated

Amphastar Pharmaceuticals, Inc. Customer Service: 1

- 800

- 423

- 4136 50%, 50mL

Luer

- Jet Prefilled Syringe

NDC 76329

- 3301

- 1

(old NDC 0548

- 3301

- 00) Amphastar

will regularly release products Amphastar is

exp eriencing a product shortage due to an increase in product demand caused by market supply issues.

Shortage per Manufacturer: Increased Demand Demand

increase for the drug. Reverified

2/11/2013

Hospira, Inc. Customer Service 1

- 877

- 946

- 7747 50%; 50mL vial

(NDC 00409

- 6648

- 02) Next

delivery mid April

Estimated recovery 2Q 2013 Shortage per

Manufacturer:

Manufacturing delay Other:

Demand increse for the drug Revised

3/8/2013

50%; 50mL Abboject Syringe (NDC 00409

- 4902

- 34) Next

delivery March Estimated recovery 2Q 2013

50%; 50mL Ansyr Syringe (NDC 00409

- 7517

- 16) Next

delivery March Estimated recovery 2Q 20132118 E. Interstate 20 • P.O. Box 1779 • Abilene, Texas USA 79604

- 1779 Within USA: 800.351.4530 • International (00 1): 325.677.1874 • Facsimile: 325.677.1372 www.StatKit.com • drdon @statkit.com March 12, 2013

Kathy Miller Manager of Emergency Response Frontier Airlines

Re: Dextrose shortage

Dear Ms

. Miller

, As you know, I am the Chief Comp liance Officer for Banyan International Corporation in Abilene, Texas. Banyan is a leading provider of emergency medical kits (EMKs) to office

- based physicians, commercial airlines and government customers with over 40 years of experience. As a core part of our business, Banyan provides FAA

- mandated EMKs to major commercial air carriers in the United States. Banyan is the only EMK provider that is also an FAA approved Repair Station for the emergency medical kits and AEDs that are required by the FAA for all airlines

. I am writing to inform you of an indefinite shortage of Dextrose ( which is one of the FAA

- mandated components of EMKs ) in the market. Supply of this product has sporadic at best for several months and has
now come to a complete stop. Hospira has notified us that they have no stock on hand to deliver. I t is also our understanding that the limited amount of product that is being produced by IMS

- Amphastar is insufficient t o cover the Hospira shortfall and is being rationed out to first

- line resp onders ( such as hospitals and paramedic units), who are receiving small quantities that are not sufficient to meet their need s. We believe the limited supply that is making its way to acute care providers is insufficient because Banyan receives numerous c alls each day from all over the country from ambulance services, fire departments, physicians and even hospitals looking for Dextrose and other drugs in short supply

. According to the Food and Drug Administration’s drug shortage index ( http://www.fda.go v/drugs/ drugsafety/ drugshortages/ucm050792.htm ), the release date for Hospira’s Dextrose product shows February but this date has already been pushed back more than once and we have every reason to expect it will be again

. It is our experience that even w hen they do release product, it is only a partial shipment and is to first

- line responders and even then only in limited supply

. The result is that Banyan (along with all other similarly situated companies) is unable to acquire Dextrose through any legitim ate channel.

Long

- term shortages of Dextrose and close to 200 other prescription medications have been caused by a combination of manufacturing problems, shortages of active pharmaceutical ingredient s (API) and generic drug manufacture r s withdrawing fr om the production of what they consider to be low profit margin products. Emergency medications (namely generic prefilled syringes and ampules), anesthesia and cancer treatments have been particularly impacted.2118 E. Interstate 20 • P.O. Box 1779 • Abilene, Texas USA 79604

- 1779 Within USA: 800.351.4530 • International (00 1): 325.677.1874 • Facsimile: 325.677.1372 www.StatKit.com • drdon @statkit.com Page 2 of 2

The situation has reach ed crisis levels, as some hospitals are being forced to schedule surgeries around the availability of anesthetics, relapses have increased for children with Hodgkin's lymphoma due to the unavailability of preferred oncology medications and paramedics in so me metropolitan areas have been forced to use recently expired emergency medications to treat patients. As noted above, manufacturers have be en rationing the drugs in short supply, making hospitals and emergency responders the first recipients of any prod uct that comes available. The shortages pose such a significant public health risk that both houses of Congress unanimously passed a bill in July 2012 called the Food and Drug Administration Safety and Innovation Act to address the issue.

Knowing the i mportance of sustaining the airline fleets and meeting the FAA requirements, Banyan’s R egulatory Affairs department contact ed the FDA’s CDER Drug Shortage Program. There was a discussion regarding drug importation from sources outside the U.S. and it was s tated that it is possible for manufacturers to import medications when there are shortages

, but there are no FDA

- approved foreign manufacturers authorized to import Dextrose into the U.S. at this time and even if there was an approved foreign manufacturer available, U.S. drug manufacturers often do not choose to import to resolve drug shortages d ue to the FDA ’s stringent lab testing and stability data requirements.

At this time, Banyan has exhausted its stock of Dextrose and has no viable source, primary or secondary, to obtain more. Should Banyan receive any Dextrose in the near future from IMS or Hospira , we are assured that it will only be in minimal increments insufficient to supply the thousands of units necessary to service the airline industry. Ban yan respectfully requests Airlines for America

, on behalf of its airline constituents

, to submit a petition for an exemption of Dextrose in FAA

- mandated EMKs until such time as the manufacturers can substantially meet the market s’ needs (o ur sources sugges t that may be late r in the year )

. Please note that in Banyan’s experience refurbishing EMKs for its airline customers for over 15 years, we estimate that Dextrose is used in less than .4% of inflight emergencies.

Please feel free to contact me with any qu estions or concerns that you may have.

Sincerely,

Don Cohen, DMD Chief Compliance Officer Banyan International Corporation