### Exemption 10721

January 24 , 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. 10 721

, Emergency Medical Equipment; 14

CFR121.803

, Revised (note revision bars in left margin)

Docket No. FAA

- 201 3

- 0201

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. 10 721 , Docket No. FAA

- 2013

-

0201 . Exemption No. 10 721 expires on March 30 , 2014

.

In addition, the petitioners request certain additional terms in the extension, if gra nted, 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) 626

- 4 228.

Extension of Exemption 10721

Exemption No. 10 721 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 conducting P art 1 21 passenger carrying operations

, f rom the

requirement to carry one single dose amp ule of Dextrose, 50% 5 0 cc injectable in required

onboard Emergency Medical Kits (EMK) when, due to a nationwide shortage as presented in

the original petit ion, they are unable to procure these items for the kits.

Justification for an extension of Exemption No. 10721 is the same as for the original

Exemption Petition, dated February 26 , 2013 . The conditions and circumstances with regard to

public int erest and safety, which warranted the original exemption, continue to exist. AlthoughPetition for Extension of Exemption 10 721

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 some confidence of

reliable, steady, adequate s upply in the foreseeable future, however the outlook remains

uncertain. Suppliers will include Dextrose in kits as it becomes available.

Supplemental Request

Exemption 10721 includes the provision that a copy of the Exemption must be carried aboard

any aircraft operating with a med ical kit that does not contain Dextrose in accordance with Part

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

Exemption inside the EMK with ou tside 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 10721 , kits in service will appear to be non

- compliant after March 30 , 2014.

The pe titioners request consideration, regardless of extension 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 earl ier 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 March

30 , 2014 will place a heavy burden on airlines with no sa fety 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 bo ar d the aircraft may not contain Dextrose

. 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 stipulating physical carriage of a

copy aboard affected aircraft be withdrawn.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

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

displayed

.

Emergency Medical Kits have an approximate shelf life of one year, the nominal duration of this

Exemption. The petitioners sug gest FAA should agree that kits in service aboard aircraft may

remain in service for their normal period due to the aforementioned logistical issue of all kits

needing revision simultaneously when the Exemption eventually expires. W e believe both FAA

and t he petition er s are well served

, and processes are simplified

, with the following substitution

within the current verbiage of Exemption 10721:



### “ ...only to the extent necessary to relieve them from the requirement to carry Dextrose 50%, 50cc,

single dose ampu le or equivalent, in required on

- board EMKs packaged/produced during the

effectivity of this Exemption when they, due to the nationwide shortage discussed herein, are

unable to procure Dextrose for the EMKs. ”

Summary of Petition for ExtensionPetition for Extension of Exemption 10 721

The petitioners request the following :

1) Extension of Exemption 10 721 pertaining to Dextrose

, that expires on March 30 , 2014.

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

normally returned for refurbishment (“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.

We have su ggested substitute wording to accomplish this end in the simplest manner.

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

are covered by the proposed extension and remain serviceable for their otherwise full

currency, despite the expiration date of March 30, 2014 that may be apparent.

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

Dextrose are in compliance with Exempt ion 10721 “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 re submitted January 24 , 2014 by:

Robert L Ireland

Managing Director, Engineering and Maintenance

Airlines for America

202

- 626

- 4228Petition for Extension of Exemption 10 721

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 AirlinesPetition 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 requiremen ts. As such, we

have provided the following communication to our clients regarding the availabilitiy of Dextrose, a

required component for Emergency Medical Kits (EMKs) and Enhanced Emergency Medical Kits

(EEMKs).

DEXTROSE. FAA

- required component: Dextros e 50%, inj. 50 mL

Reference: U.S. Title14 CFR 121.803 Emergency Medical Equipment. Exemption No. 10721

UPDATE: As of October 18, Hospira reports they will meet demand for dextrose by the 4 th quarter of

2013.

Amphastar Pharmaceuticals reports they are still experiencing a production shortage.

Beginning November 2013, MedAire expects to have stock available to include the required Dextrose

component in new and refurbished Emergency Medical Kits and Enhanced Emergency Medical Kits.

We are working with clients on an individual basis to schedule the reintroduction of Dextrose in their

medical kits.

The duration of the Dextrose Grant of Exemption terminates on March 14, 2014, unless sooner

superseded, rescinded, or extended.

For more information on the Dextrose production shortage, please refer to the following link:

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

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

Robert L. Ireland

Director, Technical Operations

Airlines for America

1301 Pennsylvania Ave. NW Suite 1100

Washington, D.C. 20004

- 1707

Re: Dextrose shortage

Dear Mr. Ireland,

I am writing to you on behalf of Banyan International Corporation to request that you petition for an

extension of Exemption No. 10721.

While Banyan is currently able to obtain Dextrose from the manufacturer, it has only recently become

available in limited quantities. Due to the limited release of this produ ct and the lack of full recovery to

date, the supply of future product is still uncertain at best. In order to avoid unnecessary disruption to

the commercial aviation industry, it would be prudent to request an extension of the existing exemption

and for m edical kits that have been issued into the field without dextrose 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 transition, av oid the logistical nightmare of rotating all

medical kits in the system prior to the March 31, 2014 cutoff date and avoid an AOG situation. An

extension would also allow the airlines to obtain the full value/life expectation of each kit that has been

servi ced in the last nine to ten months.

We request that the exemption be granted for another year in order to be able to replace this item in an

orderly fashion without disrupting the normal rotation of these kits.

We thank you in advance for your assistance. Please feel free to contact me with any questions you may

have.

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 • I nternational (001): 325.677.1874 • Facsimile: 325.677.1372

www.StatKit.com