### Exemption 10690

November 25 , 2013

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

, 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 , Docket No. FAA

- 2013

-

0034 . Exemption No. 10690 expires on January 31 , 2014

.

In addition, the petitioners request certain additional terms in the extension, if granted, to

remedy complications arising from limitations of the original gra n ted exemption.

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

, Managing Director

, Engineering and Maintenance, A4A, telephone: (202) 62 6

- 4228.

Extension of Exemption 10690

Exemption No. 10690 provides temporary relief, under certain conditions and limitations, 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 c onducting P art 1 21 passenger carrying operations

, from the

requirement 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, th ey are unable to procure these items for the kits.

Justification for an extension of Exemption No. 10689 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. AlthoughPetition for Extension of Exemption 10690

some recovery of supply is anticipated, as evidenced in the attached letters from EMK

refurbishers/suppliers MedAire and Banyan (Attachments 2 and 3) , the re is no confidence of

reliable, steady, adequate supply in the foreseeable future.

Supplemental Request

Exemption 10690 includes the provision that a copy of the Exemption must be carried aboard

any aircraft operating with a medical kit that does not contain Atropine in accordance with Part

121 Appendix A. Carriers have complied in multiple ways, including packing a copy of the

Exemption inside the EMK with outside labeling, affixing a copy of the exemption to the outside

of the kit, or carrying a copy elsewhere on the aircraft. As a result, regardless of extension of

Exemption 10690 , kits in service will appear to be non

- compliant after January 31, 2014.

The petitioners request consideration, regardless of ex tension of the Exemption, allowing

carriers to operate under the terms of the original Exemption or its extension

, if granted

, until in

service EMKs are returned for normally scheduled refurbishment, or earlier due to use or

damage. We request this procedure because if no relief is given every EMK will unnecessarily

need to be repapered with the new exemption. Processing thousands of EMKs before January

31, 2014 will place a heavy burden on airlines with no safety impact. This may be accomplished

by outside relabeling of kits with the exemption packed inside or removal of the copies of the

Exemption being carried external to the kits.

As part of the requirement under §119.43(c) to keep each of its employees and other persons

used in its operation informed of the provisions of its operations specifications that apply to that

employee’s or person’s duties and responsibilities, the certificate holders must inform

crewmembers that any emergency medical kits on boar d the aircraft may not c ontain Atropine

. Given that the need for this Exemption will continue for an unknown period

, and i n order to

avoid further potential confusion of maintenance personnel, flight crews, or perceptive

passengers, it is requested that the portion of the Exemption sti pulating physical carriage of a

copy aboard affected aircraft be withdrawn. If on board physical indication of the missing

substance remains a requirement, the date of expiration of the Exemption should not be

displayed

.

Summary of Petition for Extension

The petitioners request the following :

1) Extension of Exemption 10690 pertaining to Atropine

, that expires on January 31, 2014.

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

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

market supplies. The intent is to continue extensions for some period after supplies 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 expiration date of January 2014 that

may be apparent.Petition for Extension of Exemption 10690

4) T he extensi on should stipulate that it must be readily appar ent 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 publication in the Federal Register be waived.

Your consideration and approval of this request is appreciated.

Respectfully submitted November 25 , 2013 by:

Robert L Ireland

Managing Director, Engineering and Maintenance

Airlines for America

202

- 626

- 4228

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. Everts Air Cargo Chautauqua Airlines

Hawaiian Airlines, Inc. Miami Air International CommutAir

JetBlue Airways Corp. National Airlines Compass Airlines

Southwest Airlines Co. National Air Cargo Empire Airlines

United Airlines, Inc. Northern Air Cargo Endeavor Air

US Airways, Inc. Omni Air International Era Aviation

Air Canada (Associate Member) Ryan International Airlines ExpressJet

Sun Country Airlines GoJet Airlines

USA Jet Airlines Great Lakes Aviation

World Airways Horizon Air

Island Air

Mesa Airlines

Piedmont Airlines

PSA Airlines

Republic Airlines

Seaborne Airlines

Shuttle America

Silver Airways

SkyWest Airlines, Inc.

Trans States AirlinesPeti tion for Extension of Exemption 10690

– Atta chment 2

October 31, 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. As such, we

have provided the following communication to our clients regarding the availability of Atropine, a required

component for Emergency Medical Kits (EMKs) and Enhanced Emergency Medical K its (EEMKs).

ATROPINE. FAA

- required component: Two single dose ampules of Atropine

Reference: U.S. Title14 CFR 121.803 Emergency Medical Equipment. Exemption No. 10690; 10694

UPDATE: Hospira continues to report a supply shortage of Atropine. There is lim it ed availability of

Atropine via wholesale sources, however not at a sufficient level for MedAire to supply carriers on a

consistent basis.

As such, MedAire will continue to follow Exemptions 10690 and 10694, which t erminates on January, 31,

2014, unless sooner superseded, rescinded, or extended. While the status of Atropine availability could

change with short notice, MedAire recommends that carriers subject to the regulation cons ider preparing

an appeal to the FAA for an extension of this exemption.

Th is exemption will allow MedAire to continue to provide our client ca rriers with new and refurbished

Emergency Medical Kits and Enhanced Emergency Medical Kits that comply with FAA regulations.

MedAire will continue to monitor the availability of Atropine and provide updates as available.

For more information about the Atropine production shortage, please visit:

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

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

Sincerely,

Heidi MacFarlane Paulo Alves, MD, MSc, FAsMA

Vice President, Strategic Development Vice President, Aviation and Maritime Health

MedAire, an International SOS company MedAire, an International SOS companyPetition for Extension of Exemption 10690

– Attachment 3

November 11, 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,

I am writing this letter as a follow up to our January 10, 2013 request for exemption of Atropine as a

required component of the FAA mandated emergency medical kit. Since the time the exemption was

granted earlier this year until just this p ast week, product has been unavailable in all but the sparsest of

quantities from one manufacturer and not at all from the other. Banyan finally did receive a shipment of

product consisting of orders we had placed months ago and that are just now being fil led. Even with this

shipment, we do not currently have adequate supply to refurbish all outstanding medical kits for all of our

customers. The FDA drug shortages website states that Hospira’s product still shows a shortage per

manufacturer with some availa bility and Amphastar is still experiencing a product shortage due to an

increase in product demand caused by market supply issues. The deadlines throughout the year for this

product and others have notoriously been extended time and time again. Due to past performance and the

irregularity of receipt of product, the supply of future product is still uncertain at best. It is for these reasons

that we ask you to petition for an extension of exemption number 10690. We feel it would also be most

beneficial to re quest that medical kits that have been issued into the field sans atropine under this exemption

be allowed to remain in the field until such a time as they are returned for refurbishment due to use or

normal expiration. This would allow for a smooth transi tion and would prevent the logistical nightmare of

rotating all medical kits in the system prior to the 01/31/13 cutoff date.

Thank you in advance for your assistance in this request.

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

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