January 1 4 , 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 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 their 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 a n EMK to assist crewmembers or other volunteers in responding to an in

- flight medical emergency. 1 That requirement was extended in

1996 to cover 20

- 30 seat commuter aircraft. 2 In 2001, the FAA issued new regulations implementing the Aviation Medical Assistance Act of 1998, which among other provisions called for airlines to augment

their EMKs and include Atropine

. 3 The regulatory provision expanding the required contents of the EMK took effect April 12, 2004, and app lies 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 airpl ane to be operated, 6 and current Master Minimum Equipment List (MMEL) relief requires a carrier to repair or replace an EMK within one flight of an incomplete, missing or inoperative EMK ; there is no MEL relief permitting a carrier to depart with an EMK mi ssing Atropine

, 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

January 14, 2013



### 2 Current Shortage of Atropine

Atropine , a required component of EMKs since 2004, is a “ medicine use d mainly to increase heart rate that may be needed to assist a passenger with an unstable cardiac rhythm. ” 8 Part 121, Appendix A specifies that an EMK must include two Atropine 0.5 mg, 5 cc injectable single dose s or an Atropine equivalent

.

Historically

, major EMK airline suppliers and refurbishers MedAire , Inc. and Banyan International Corporation obtained Atropine from some of the four producers in the United States, Amphastar

Pharmaceuticals Inc.

, Hospira, Inc.

, American Regent/Luitpold , and West

- Ward Pharmaceuticals

. 9 Both MedAire and Banyan provided letters (see enclosures 2 and 3) stating there is currently a critical shortage

of A tr o p ine in the U.S. and that it will be impossible to supply EMKs with Atropine to our members 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. 10 This production shortage has resulted in the two remaining suppliers, West

- Ward and Amphastar ration ing remaining supplies to first

- line responders such as hospitals and paramedic units. 11 In addition, according to Banyan, there are no FDA

- approved foreign Atropine manufacturers authorized to import Atropine into the U.S. to relieve the shortage. Also, while FDA has the authority to extend the expiration date on drugs such as Atropine, the drug manufact urer must petition the FDA with drug stability data asking for an extension , which no manufacturer has done. 12 Finally, Appendix A permits carriers and suppliers to provide an Atropine equivalent , however, according to MedAire (and confirmed by in house

ai r carrier medical staff) there is no equivalent substitute for Atropine. 13

Thus far, airlines and their kit suppliers have been able 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 refurbishment. In addition, all EMKs are restocked periodically since some of the medications they contain have a shelf

life of as litt le as one year. During the shortage, EMKs in which Atropine has been used or has expired cannot be refurbished and returned to use, leaving the airline potentially without the means to comply with the requirements of Appendix A. 14

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 EM K containing two single Atropine doses as specified in part 121 Appendix A, EMK requirements, paragraph 2

.

R easons for seeking the relief i nclude: 1) Suppliers cannot provide EMKs stocked with Atropine because r ecent pharmaceutical manufacturing changes have reduced the availability of Atropine (also referred to as Atropine Sulfate) and m anufacturers 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 provider/refurbisher MedAire will deplete its supply by January 25, 2013 and Banyan reports it has already depleted its Atropine supply

8 See 65 FR 33726; FAA Advisory Circular AC

- 121

- 33B, “Emergency Medical Equipment,” January 12

, 2006

. 9 See FDA website concerning “Atropine Sulfate Injection” manu facturers at http://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm314739.htm#atropine ; See also http://www.medaire.com/solutions/airlines/solutions/medical

- kits

- equipment/medical

- equipment

- details ; and http://www.statkit.com/aviation

- medicine/aviation

- medicine

- and

- banyan

- 9

- 9.html

10 See enclosed Banyan letter page 1 and FDA website http://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm314739.htm#atropine

11 See Banyan letter page 1.

12 See Id

. 13 See MedAire letter page 1.

14 See Id

.EMK Petition for Exemption

January 14, 2013



### 3 5) Atropine is rarely used; Banyan estimates that Atropine is used less than one time per one

thousand units serviced 6) Airlines contacting A4A have indicated their supply of EMKs with unexpired Atropine will be depleted soon, some within two weeks

Without the requested relief carriers will face the decision to ground aircra ft

.

Therefore, w e 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 I nterim R elief

T he exemption process is likely to take more than two weeks to complete and therefore we also r equest

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 airlines to comply with section 121.803 , part 121 Appendix A, and

MEL requirements when Atropine need s to be restocked in the EMK. This creates the possibility that

aircraft would have to be taken out of service un til additional supplies can be obtained. While this would be a last resort, it is not implausible. Grounding otherwise airworthy aircraft for this reason alone would disrupt air service and is not in the interest of the traveling public. Granting this exem ption 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 Atropine has additionally brought to light its limited usage

. MedAire has reported that roughly 1% of EMKs returned for refurbishment are missing Atropine due to use, loss, or damage. A returned EMK, unless opened for use, represents approximately one year of service and is generally returned for replacement of ex piring contents. MedAire and Banyan have both reported to A4A qualitatively that the predominance of Atropine usage for airline purposes has been due to expiration, not administration to passengers. Banyan reports that Atropine is used less than one time per one thousand

units serviced. 15

MedAire and Banyan also regularly compete with hospitals and other ground

- based users to obtain Atropine who use the substance more often than discard it through expiration. Banyan reports that d uring this shortage

, producers have adopted an Atropine distribution system that places acute care providers (such as hospitals) ahead of airlines ; even with this system acute care providers are not receiving enough supply, making it even less likely that EMK providers will re ceive Atropine in the near future. 16

EMKs are not intended to be comprehensive, or to include treatment for every possible medical condition, but instead provide options for addressing the most frequent types of medical emergencies. 17 The

removal of the EMK requirement for Atropine would not adversely affect the safety of the traveling public because it is used infrequently

. 18

15 Banyan letter page 2.

16 Id

. 17 FAA Advisory Circular AC

- 121

- 33B, 1/12/2006

18 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 maintaining a second EMK for each airplane, which requires acquiring additional atropine.EMK Petition for Exemption

January 14, 2013



### 4 A S ummary of this P etition that FAA C ould P ublish 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 air lines from having to carry Atropine in EMK s 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 unschedul ed air transport service.

Reasons for E xercising the P rivileges of the R equested E xemption O utside 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 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 and adequate medical supplies,” and recommends that these supplies include, for aircraft authorized to carry more than 100 passengers on a flig ht 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 Atro pine in an EMK on an aircraft operating outside the U.S. therefore would

not violate ICAO requirements.

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 t o Part 121 pertaining to the provision of Atropine in the EMK for one year or until Atropine is once again commercially available.

Respectfully s ubmitted January 1 4 , 2013 by:

Douglas Mullen

Assistant General Counsel

Airlines for America 1301 Pennsylvania Ave. NW

Suite 1100 Washington, DC 20004 Stacey Bechdolt, Esq. Director, Safety & Technical Affairs Regional Airline Association 2025 M Street, NW

Suite 800 Washington, DC 20036

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

January 14, 2013



### 5 George Paul

Director of Technical Services

National Air Carrier Association

1000 Wilson Boulevard

Suite 1700 Arlington, Virginia 22209

- 3928

cc: Mr. John Allen

Federal Aviation Administration Director, Flight Standards Service, AFS

- 1 800 Independence Ave., SW Washington, DC 20 591

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, 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

Enclosures/Enclosure 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 Airlines, 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 Airlines SkyWest Airlines, Inc.

Trans States AirlinesJanuary 8, 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 kits for airlines subject to Part 121 requirements.

Recent pharmaceutical manufacturing changes have reduced the availability of Atropine. Atropine (also referred to as Atropine Sulfate) is a required drug according to 14 CFR Part 121.803, Appendix A.

Based on the current availability of Atropine and MedAire’s historical production data for producing new and refurbished medical kits, MedAire anticipates its current supplies of Atropine will be depleted on or about January 25, 2013.

If Atropine manufacturers cannot supply the additional quantities of the drug once the MedAire supplies are depleted, MedAire will be unable to provide FAR-compliant kits to commercial carriers.

Based on a formal review by MedAire’s Medical Equipment Review Board, an acceptable alternative medication for Atropine currently does not exist.

MedAire has been in communication with suppliers about the availability of Atropine on a daily basis. The suppliers have indicated that additional access to stocks will be made available depending on demand levels, but have not provided any additional fulfillment forecasts.

Manufacturers continue to place Atropine orders on hold, which is the manufacturers ’ primary method of apprising clients of Atropine’s availability.

For additional information about the Atropine shortage, visit: http://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm050792.htm

Thank you for your assistance. Please let us know if we can provide 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 company2118 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 January 10, 2013

Robert L. Ireland Director, Technical Operations

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

Re: Atropine shortage

Dear Mr. Ireland,

My name is Dr. Don Cohen and I am the Chief Complia nce 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 majo r commercial air carriers in the United States. Banyan is the only EMK provider that is also an F AA 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 Atropine (which is one of the FAA-mandated components of EMKs) in the market. In early Nove mber, we received an industry-wide announcement that Hospira would not be producing or taking orders for Atr opine for an indeterminate period of time. It is our understanding that due to manufacturing difficulties, Hospira decided to indefinitely postpone a production run of Atropine; this delay resulted in acute shorta ges of this product at IMS-Amphastar and West-Ward Pharmaceuticals (the only other manufacturers). It is also our understanding that the limited amount of product that is being produced by is being rationed out to first-line responders (such as hospitals and paramedic units), who are receiving small quantities that ar e not sufficient to meet their needs. We believe the limited supply that is making its way to acute car e providers is insufficient because Banyan receives numerous calls each day from all over the country from ambulance services, fire departments, physicians and even hospitals looking for Atropine and other drugs in short supply.

Banyan has repeatedly contacted IMS-Amphastar a nd West-Ward Pharmaceuticals for release dates for their Atropine products, but they are refusing new orders from any organization other than first-line responders. The result is that Banyan (along with all other similarly situated companies) is unable to acquire Atropine through any legitimate channel.

According to the Food and Drug Administration’s drug shortage index (http://www.fda.gov/drugs/ drugsafety/drugshortages/ucm050792.htm), no release date has been set for Hospira’s Atropine product.

Long-term shortages of Atropine and close to 200 ot her prescription medications have been caused by a combination of manufacturing problems, shortages of active pharmaceutical ingredients (API) and generic drug manufacturers withdrawing from the production of what they consider to be low profit margin products. Emergency medications (namely generic pr efilled 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 hosp itals are being forced to schedule surgeries around the availability of anesthetics, relapses have increas ed for children with Hodgkin's lymphoma due to the unavailability of preferred oncology medications and pa ramedics in some metropolitan areas have been forced to use recently expired emergency medications to treat patients. As noted above, manufacturers have been rationing the drugs in short supply, making hospita ls 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 contacted Ms. Susie Dill with the FDA’s CDER Drug Shortage Program. There was a discussion regarding drug importation from sour ces outside the U.S. Ms. Dill stated said that it is possible for manufacturers to import medications when there are shortages, but she indicated there are no FDA-approved foreign manufacturers authorized to import Atropine into the U.S. at this time. She also stated that even if there was an approved foreign 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. There was also discussion about exte nding the expiration dating on existing product and Ms. Dill stated that the drug manufacturer must request an expiration dating extension and provide the FDA with drug stability data for each product. The FDA considers manufacturer requests for extending expiration dating on a case-by-case basis. We later cont acted our representative at Hospira to discuss an expiration dating extension and they are not pursuing an extension for Atropine at this time. At our request and on our behalf, Ms. Dill emailed her drug shortage c ontacts at Hospira and IMS, and told them of our dilemma. Both companies were willing to move us up the list for shipments to meet our short term needs for several of the other prefills that are in short supply (e.g. Epinephrine and Lidocaine) but each could only commit to providing minimal allocations of Atropine as it is being rationed. We received a small shipment of Atropine from Hospira’s remaining marketing stock in early December and have yet to receive any from IMS, as promised.

At this time, Banyan has exhausted all of its stock of Atropine and has no viable source, primary or secondary, to obtain more. Should Banyan receive any Atropine in the near future from IMS, we are assured that it will only be in minimal increments of 10 to 20 units, which is insufficient to supply the thousands of units necessary to service the airlin e industry. Banyan respectfully requests Airlines for
America, on behalf of its airline constituents, to s ubmit a petition for an exemption of Atropine in FAAmandated EMKs until such time as the manufacturers can substantially meet the markets’ needs (our sources suggest that may be as late as 2014). Pleas e note that in Banyan’s experience refurbishing EMKs for its airline customers for over 15 years, we estimat e that Atropine is used less than one time per one

thousand units serviced.

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