### Exemption 10690 C

October 30 , 2014

U.S. Department of Transportation

Docket Operations

West Building Ground Floor

1200 New Jersey Ave S.E.

Room W12

- 140

Washington, D.C. 20590

Sent to web site: http://www.regulations.gov/

SUBJECT: Petition for Extensi on of Exemption No. 10690 C

, Emergency Medical Equipment; 14

CFR121.803

Docket No. FAA

- 201 3

- 0034

Ladies/Gentlemen:

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 Attac hment 1) and similarly

situated air carriers petitions for th e renewal of Exemption No. 10690 C , Docket No. FAA

- 2013

-

0034 . Exemption No. 10690 C expires on January 31 , 2015

.

The appropriate technical contact for the purposes of this application is Robert Ireland

, Managing Director

, Engineering and Maintenance, A4A, telephone: (202) 626

- 4228.

Extension of Exemption 10690

Exemption No. 10690 C extended temporary relief originally granted by Exemption 10690 in

January 2013 , under certain conditions and limi tations, from specific provisions of 14 CFR

§121.803(c)(3) and Part 121 Appe n dix A , to the extent necessary to allo w Part 119 carriers

conducting P art 1 21 passenger carrying operations that require operators to carry two single

dose amp ules of Atropine 5cc injectable in required onboard Emergency Medical Kits (EMK)

when, due to a nationwide shortage as presented in the original petition, they are unable to

procure these items for the kits.

Justification for an extension of Exemption No. 10689 C is the same as for the original

Exemption Petition, dated January 14, 2013 . The conditions and circumstances with regard to

public interest and safety, which warranted the original exemption, continue to exist. Although

limited recovery of supply is occurring , as evidenced in the attached letters from EMK

refurbishers/suppliers MedAire and Banyan (Attachments 2 and 3) , the re is no confidence ofPetition for Extension of Exemption 10690

reliable, steady, adequate supply in the foreseeable future. When available, the product is being

placed in new and r efurbished kits.

Summary of Petition for Extension

The petitioners request the following :

1) Extension of Exemption 10690 C pertaining to Atropine

, that expires on January 31,

2015

.

2) The extension should allow kits to remain in the field that are short of the substances

until normally returned for refurbishment (“grandfathering”), regardless of recovery of

market supplies. The intent is to continue extensions for some period after supp lies are

restored to avoid a sudden need to refurbish kits off

- schedule, unreasonably straining

supply capabilities.

3) Carriers may use their own effective means to communicate that kits already in the field

are covered by the proposed extension despite the Exemption expiration date that may

be visible

.

4) T he extensi on should stipulate that it must be readily apparent that kits not containing

Atropine are in compliance with Exemption 10690 “as revised or extended”

, without

displaying the expiration date.

5) Deletion of the requirement to carry a copy of the Exemption on board the affected

aircraft.

The renewal of this E xemption is not a controversial issue. As the renewal of this E xempt ion is

not precedent setting, A4 A requests that publ ication in the Federal Register be waived.

Your consideration and approval of this request is appreciated.

Respectfully submitted October 30 , 2014 by:

Robert L Ireland

Managing Director, Engineering and Maintenance

Airlines for America

202

- 626

- 4228Petition for Extension of Exemption 10690

Stacey Bechdolt, Esq.

Director, Safety & Technical Affairs

Regional Airline Association

2025 M Street, NW

Suite 800

Washington, DC 20036

Enclosures/Petition for Extension of Exemption 10690

– Attachment 1

Attachment 1

Airlines for America National Air Carrier

Association Regional Airline Association

(Part 121 passenger carrying) (Part 121 passenger carrying) (Part 121 passenger carrying)

Alaska Airlines Air Transport International Air Wisconsin Airlines Corp.

American Airlines Allegiant Air American Eagle Airlines

Atlas Air, Inc. Atlas Air, Inc. Cape Air

Delta Air Lines, Inc. National Airlines Chautauqua Airlines

Hawaiian Airlines, Inc. Omni Air International CommutAir

JetBlue Airways Corp. Sun Country Airlines Compass Airlines

Southwest Airlines Co. Empire Airlines

United Airlines, Inc. Endeavor Air

US Airways, Inc. Era Aviation

Air Canada (Associate Member) ExpressJet

GoJet Airlines

Great Lakes Aviation

Horizon Air

Island Air

Mesa Airlines

Piedmont Airlines

PSA Airlines

Republic Airlines

Seaborne Airlines

Shuttle America

Silver Airways

SkyWest Airlines, Inc.

Trans States AirlinesPetition for Extension of Exemption 10690

– Atta chment 2

October 22, 2014

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 air lines subject to Part 121 requirements. As such, we

can provide the following regarding the current availability of Atropine, a required component for

Emergency Medical Kits (EMKs) and Enhanced Emergency Medical Kits (EEMKs).

Currently our Atropine supply is not readily available with our minimum one

- year dating requirement,

however the general supply of the drug remains acceptable. We have more product on order that we

expect to be year or better dated.

While this is an update as of today, it is importan t to note that drug availability is a dynamic situation and

is subject to change on very short notice. Availability of Atropine remains a concern for our operations.

Thank you for your assistance. Please let us know if we can provide any additional inform ation.

Sincerely,

Heidi MacFarlane

Vice President, Aviaition Work Health &

Emergency Services Products

MedAire, an International SOS company

Paulo Alves, MD, MSc, FAsMA

Vice President, Aviation and Maritime Health

MedAire, an International SOS companyPetition for Extension of Exemption 10690

– Attachment 3

October 21, 2014



### 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,

I am writing this letter as a follow up to our November 11. 2013 request for extension of

Exemption No. 10690. As the extension date of January 31, 2015 approaches, I regret to inform

you that the flow of Atropine from the manu facturers is still not dependable. Although we have

been receiving stock and placing it in all incoming kits for months, the FDA Drug shortages

website still shows Atropine currently in shortage. Hospira states it is available but they are

having a shorta ge per manufacturer and Amphastar states it is still experiencing a product

shortage due to an increase in product demand caused by market supply issues. This is the same

language they used in 2013 when the first extension was granted.

As I stated, althou gh the product is currently available, through past performance there is no

guarantee that product will continue to be available in a dependable fashion for the foreseeable

future. Rather than let this extension lapse and then in two months’ time find ours elves in the

same situation as previous to the granting of the exemption, we request that Exemption No.

10690 be extended for another year. We assure you that as long as product is obtainable, all

incoming kits will continue to be refurbished with viable p roduct as required by the original

statute. We simply would like to maintain the option of not including it in the event the

manufacturers are unable to continue to keep up with demand.

Thank you for your continued assistance in this matter

Sincerely,

Don Cohen, DMD

Chief Compliance Officer

Banyan International Corporation

2118 E. Interstate 20 • P.O. Box 1779 • Abilene, Texas USA 79604

- 1779

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

www.StatKit.com