February 26, 2013

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 Exemption

Reference: Emergency Medical Equipment; 14 CFR 121.803

Dear Sir or Madam:

In accordance with the provisions of Title 14, Code of Federal Regulations (14 CFR) §11.63 and §11.81, Airlines for America, the National Air Carrier Association, and the Regional Airline Association, on behalf of their passenger airline members (See enclosure 1) and similarly

- situated air carriers, petition 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 suspend for one year a requirement for air carriers to include Dextrose in the emergency medical kits (EMKs) of thei r aircraft during flight operations because of a manufacturing supply shortage leaving airlines without the means to comply with the requirements of Appendix A.

B ackground

Since 1986, large passenger

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

- flight medical emergency. 1 FAA has required a single Dextrose dose ampule or equivalent since the 1986 EMK final rule. The requirement to carry an EMK was

extended in 1996 to cover 20

- 30 seat commuter aircraft. 2 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. 3 The regulatory provision expand ing the required contents of the EMK took effect April 12, 2004, and applies to all airplanes for which a flight attendant is required, 4 which currently would include all passenger

- carrying aircraft having a seating capacity of more than nine passengers. 5 The EMK is considered a “no

- go” item that must be on board for the airplane to be operated, 6 and current Master Minimum Equipment List (MMEL) relief requires a carrier to refurbish or replace the EMK within one flight after it has been used or otherwise be comes incomplete; there is no MEL relief permitting a carrier to depart with an EMK missing Dextrose, beyond the one flight

relief described above. 7

1 Emergency Medical Equipment Requirements Rule, 51 Fed. Reg. 1218 (Jan. 9, 1986).

2 60 Fed. Reg. 65831 (Dec. 20, 1995).

3 66 Fed. Reg. 19028 (April 12, 2001).

4 14 C.F.R. §121.801(c)(3).

5 14 C.F.R. §121.391(a)(1).

6 See 66 Fed. Reg

. 19033.

7 See FAA MMEL Policy Letter 73, “MMEL Relief for Emergency Medical Equipment.”

### EMK Petition for Exemption

– Dextrose

February 26, 2013

Current Dextrose Shortage

Dextrose, a required component of EMKs since 1986

, 8 is a medicine used to treat acute or severe hypoglycemia which may appear in diabetic passengers. Part 121, Appendix A specifies that an EMK must include one Dextrose 50%/50 cc injectable single dose or a Dextrose equivalent.

Historically, major EMK airline suppliers and r efurbishers MedAire, Inc. and Banyan International Corporation, obtained Dextrose from two producers in the United States, Amphastar Pharmaceuticals Inc. and Hospira, Inc. MedAire and Banyan have notified operators and provided letters to A4A (see

enclosur es) 9 stating there is currently a critical shortage of Dextrose in the U.S. and that it will be impossible to supply EMKs with fresh Dextrose to our members after February 20, 2013. This shortage is due to multiple factors including overall demand and a manufacturing shortfall. The manufacturers have indicated that backlogged demand should be fulfilled by late second quarter 2013, with a ramp up of supply in the meantime. MedAire predicts the shortage will affect their specific supply until late second

qu arter 2013 or after. Finally, Appendix A permits carriers and suppliers to provide a Dextrose equivalent and MedAire states two Dextrose 25% doses (equivalent to one 50% dose) or one 1mg Glucagon dose (providing similar therapeutic effects) would be equall y effective alternatives 10 but the future availability of these alternative drugs is uncertain.

Refurbishers report that they are often unaware of an impending drug shortage until they experience a

back

- order notification. The Atropine and Dextrose shortage s are good examples of drug shortages that surfaced with little notice. The FDA does not require timely manufacturer drug shortage notices and therefore, FDA is not a source for advance information.

Thus far, airlines and their kit suppliers have been ab le to address temporary shortages through a variety of accommodations. Ordinarily, airlines maintain 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 refurbis hment. 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 the early portion of this shortage, EMK providers refurbished kits using

Dextrose from EMKs that were retu rned before their normal shelf

- life expiration date. However, when that supply was consumed, , kits could no longer be refurbished and returned to use, leaving the airline without the means to comply with the requirements of Appendix A. 11 Both MedAire and B anyan report they have exhausted all supplies at this time. MedAire has already begun notification to airlines that they have no means to supply Dextrose, and absent an exemption, can no longer supply FAA

- complaint

EMKs. 12

The Applicable Regulations and Rel ief Sought

We seek exemption from 14 CFR 121.803(c)(3), which requires passenger

- carrying airplanes to be equipped with an EM K containing Dextrose as specified in part 121 Appendix A, EMK requirements, paragraph 2. We also request that FAA approve the Dex trose substitutes listed, below so that carriers could voluntarily use them as a substitute for Dextrose if the drugs become available during the requested exemption period.

 Dextrose 25% which may be given at twice the 50 cc dosage, or

 Glucagon 1mg kit (dr y powder and water reconstitution kit)

8 51 Fed. Reg. 1223.

9 MedAire letter to Robert Ireland, A4A, dated February 21, 2013, enclosure 3 ; Banyan letter to Robert Ireland, A4A, d ated February 22, 2013, enclosure 2.

10 See also, Comparison of intravenous glucagon and dextrose in treatment of severe hypoglycemia in an accide nt and emergency department , Diabetes Care, Volume 10, No. 6, November

- December 1987.

11 See MedAire letter page 1.

12 MedAire notification to Alaska Airlines, copied by email to Robert Ireland, A4A, February 22, 2013

### EMK Petition for Exemption

– Dextrose

February 26, 2013

* Note: According to MedAire Dextrose 25% currently is unavailable; the availability of Glucagon as an approved substitute is uncertain.

Reasons for seeking the relief include:

1) Suppliers cannot provide EMKs stocke d with Dextrose because recent pharmaceutical manufacturing conditions have reduced the availability of Dextrose and manufacturers have only speculated on further availability. 2) Replacement supplies of Dextrose cannot be imported from foreign manufacturers. 3) The only suggested substitutes are Glucagon and Dextrose 25%. 4) Primary kit provider/refurbishers Banyan and MedAire have exhausted their supply of

Dextrose. 5) Dextrose is rarely used; having been recommended during approximately .02% in

- flight

consultations provided by MedAire in 2012 13 . Banyan estimates that Dextrose has used in fewer than 0.4% of inflight emergencies reported to them in 15 years. 6) Airlines contacting A4A have indicated their supply of EMKs with unexpired Dextrose will be depleted soon, and FA A

- complaint EMKs cannot be supplied.

Without the requested relief carriers will face the decision to ground aircraft

.

Therefore, we request relief from the requirement to carry Dextrose in an EMK for a period of one year from the date of granting this p etition, or until supplies have stabilized with availability to airline sources. Further, we also respectfully request that the Exemption, if granted, not require a PIC pre

- flight briefing on Dextrose but instead require that the “certificate holder” info rm the crew. Flight attendants will know if the EMK includes Dextrose because of mandatory pre

- flight safety inspections and EMK labeling from the refurbishers. Alternatively, FAA could require that carriers provide a bulletin to flight attendants.

Reque st for Interim Relief

The exemption process is likely to take more than two 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 Dextrose 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 airlines to comply with section 121.803, part 121 Appendix A, and MEL requirements when Dextrose 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 i mplausible. Grounding otherwise 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.

Granting the Exemption Would Not Adversely Affect Safety

The shortage of Dextrose has additionally brought to light its limited usage. While Dextrose is important for certain types of emergency medical treatment, it is infrequently used. MedAire, which provides emergency medical consultation to airlines as well as supplying EMKs, estimates that in 2012, Dextrose was recommended during app roximately 0.02% in inflight consultations, or five out of 25,000 , while Banyan similarly states a usage rate of 0.4% of all inflight emergencies known to them over a 15 year period. According to Banyan, EMK refurbishers also regularly compete with hospit als and other ground

based users of Dextrose who use the substance more often than discard it through expiration. Banyan reports that during this shortage, producers have adopted a distribution system that places acute care providers (such as hospitals) ah ead of airlines; even with this system acute care providers are not

13 MedAire letter, page 2

### EMK Petition for Exemption

– Dextrose

February 26, 2013

receiving enough supply, making it even less likely that EMK providers will receive Atropine in the near

future. 14

EMKs are not intended to be comprehensive, or to include treatment for eve ry possible medical condition, but instead provide options for addressing the most frequent types of medical emergencies. 15 The removal of the EMK requirement for Dextrose would not adversely affect the safety of the traveling public

because it is used inf requently. 16 Safety will also not be adversely impacted if the FAA approves equivalent drug substitutions.

A Summary of this Petition that FAA Could Publish in the Federal Register

Petitioners: Airlines for America, the National Air Carrier Association, and the Regional Airline Association

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 Dextrose 50%/50cc injectable ampules 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 scheduled and unscheduled air transport service.

Reasons for Exercising the Privileges of the Requested 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 U.S. carriers wo uld 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 and 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 “Dextrose

– injectable”. 17 Absence of Dextrose in an EMK on an aircraft operating outside the U.S. therefore would not violate ICAO requirements.

14 Banyan letter page 2.

15 FAA Advisory Circular AC

- 121

- 33B, 1/12/2006

16 A4A further notes that a recent FAA decision to reduce MEL relief allowing only one flight before restocking an opened EMK instead of three flights results in many carriers purchasing and maint ain ing a second EMK for each airplane , which requires acquiring additional atropine.

17 ICAO, International Standards and Recommended Practices, Annex 6 to the Convention on International Civil Aviation (Ninth Edition, July 2010), Part I, para. 6.2.2

### EMK Petition for Exemption

– Dextrose

February 26, 2013

Conclusion

For the foregoing reasons, we respectfully requ est 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 Dextrose in the EMK for one year or until Dextrose is once again commercially available.

Respectfully submitted Februar y 26, 2013 by:

Douglas Mullen Stacey Bechdolt, Esq.

Assistant General Counsel Director, Safety & Technical Affairs

Airlines for America Regional Airline Association 2025 M Street, NW

Suite 800 Washington, DC 20036

George Paul

Director of Technical Services

National Air Carrier Association

1000 Wilson Boulevard

Suite 1700 Arlington, Virginia 22209

- 3928

Enclosures/

cc: Mr. John Allen Mr. Steve Douglas

Federal Aviation Administration Federal Aviation Administration Director, Flight Standards Service, AFS

- 1 Flight Standards Service 800 Independence Ave., SW Aircraft Maintenance Division, AFS

- 300 Washington, DC 20591 470 L’Enfant Plaza, SW Washington, DC 2002 4

Mr. John Duncan

Federal Aviation Administration Deputy Director for Policy, Flight Standards, AFS

- 2P 800 Independence Ave., SW Washington, DC 20591

Mr. Les Smith

Federal Aviation Administration Flight Standards Service Air Transport Division, AFS

- 200 800 Independence Avenue, S.W., Washington, DC 20591Enclosure 1

Passenger Airline Association Members

Airlines for America National Air Carrier

Association Regional Airline Association

Alaska Airlines Air Transport International Aerolitora

American Airlines Allegiant Air Air Wisconsin Airlines Corp.

Atlas Air, Inc. Atlas Air, Inc. AirNet Systems Inc.

Delta Air Lines, Inc. Everts Air Cargo American Eagle Airlines

Hawaiian Airlines, Inc. Kalitta Air Cape Air

JetBlue Airways Corp. Lynden Air Cargo Chautauqua Airlines

Southwest Airlines Co. Miami Air International CommutAir

United Air Lines, Inc. National Airlines Compass Airlines

US Airways, Inc. National Air Cargo Empire Airlines

Air Canada (Associate Member) Northern Air Cargo Era Aviation

Omni Air International ExpressJet

Ryan International Airlines GoJet

Southern Air Grand Canyon Airlines/Scenic

Sun Country Airlines Great Lakes Aviation

USA Jet Airlines Horizon Air

World Airways Island Air

Jazz Air

Mesaba Aviation

New England Airlines

Piedmont Airlines

Pinnacle Airlines, Inc.

PSA Airlines

Republic Airlines

Seaborne Airlines

Shuttle America Silver Airways SkyWest Airlines, Inc.

Trans States Airlines2118 E. Interstate 20 • P.O. Box 1779 • Abilene, Texas USA 79604

- 1779

Within USA: 800.351.4530 • International (001): 325.677.1874 • Facsimile: 325.677.1372

www.StatKit.com • drdon@statkit.com February 22 , 2013

Robert L. Ireland Director, Technical Operations

Airlines for America 1301 Pennsylvania Avenue NW Suite 1100 Washington, D.C. 20004- 1707

Re: Dextrose shortage

Dear Mr. Ireland,

My name is Dr. Don Cohen and I am the Chief Compliance 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. It is also our understanding that the limited amount of product that is being produced by IMS-Amphastar is insufficient to cover the Hospira shortfall and is being rationed out t o first-line responders (such as hospitals and paramedic units), who are receiving small quantities that are not sufficient to meet their needs. We believe the limited supply that is making its way to acute care providers is insufficient because Banyan

re ceives numerous calls 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.gov/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 when 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 legitimate 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 ingredients (API) and generic drug manufactu re rs withdrawing from 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 (001): 325.677.1874 • Facsimile: 325.677.1372

www.StatKit.com • drdon@statkit.com Page 2 of 2

The situation has reached 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 some 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 product 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 importance of sustaining the airline fleets and meeting the FAA requirements, Banyan’s Regulatory 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 stated 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

fo reign manufacturer available, U.S. drug manufacturers often do not choose to import to resolve drug shortages due 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. Banyan 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 suggest that may be later 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 questions or concerns that you may have.

Sincerely,

Don Cohen, DMD Chief Compliance Officer Banyan International Corporation

### February 21, 2013

Robert L. Ireland Director, Technical Operations

Airlines for America ®


### 1301 Pennsylvania Avenue NW, Suite 1100 Washington, D.C. 20004-1707

Dear Mr. Ireland,

MedAire produces FAR-compliant medical ki ts for airlines subject to Part 121 requirements.

Recent pharmaceutical manufacturing c hanges 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 De xtrose. Should carriers request new medical kits, or r equest refurbishment of existing medical kits with expired or missing Dextrose, MedA ire will be unable to provid e FAR-compliant kits to

commercial carriers.

Beginning today, we are coor dinating with carriers to re-f urbish only those used and expired medical kits which st ill contain Dextrose that has not yet expired. In these cases, the kits will be usable fo r only the period of time in wh ich the existing Dextrose is usable—dating that varies from 1 to 11 mont hs. For kits containing expired Dextrose,

we are not able to refurb ish them at this time.

The manufacturers have indicated that they will begin distributing the drug again sometime in February and antici pate that availability will meet demand sometime in Q2 2013. This timeline is dynamic, however, and once distribution begins again, distribution

is at the discretion of the manufacturer. T he typical distribution will be to first line medical facilities and emergency response units and finally to suppliers such as MedAire. To that end, we ant icipate that this shortage ma y extend to the end of Q2 2013 or longer.

For additional information about the Dextrose production shortage, please refer to the following links: http://www.fda.gov/Drugs/DrugSafet y/DrugShortages/ucm 314739.htm#dextrose http://www.ashp.org/DrugShortage s/Current/bulletin.aspx?id=988

### Based on a formal review by MedAire’s Medi cal Equipment Review Board, there are two acceptable equivalent medications for t he Dextrose 50%/50 cc (single dose ampule or equivalent) requirement:

• Glucagon 1mg-- Although not an identical product, gl ucagon 1 mg will achieve similar results in the majority of the popul ation by raising the blood glucose levels in passengers with severe hypoglycemia.

• Dextrose 25% [2 doses]. Note: There is also currently a shortage of Dextrose

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 case s were serious enough to call for use of Glucagon [which some airlines stock] or Dextrose-- the nec essary intervention to manage the medical emergency. It should be noted that these dr ugs are indicated in cases of severe hypoglycemia which although uncomm on could be life-threatening.

Please let us know if we can pr ovide any additional information.

Sincerely,

Heidi MacFarlane

Vice President, Strategic Development MedAire, an International SOS company Paulo Alves, MD, MSc, FAsMA

Vice President, Aviation and Maritime

Health MedAire, an International SOS company