THE FOONT LAW FIRM, LLC

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Brian E. Foont, Esq.

Admitted in NY, VA, MD and DC

September 30, 2013

VIA ELECTRONIC SUBMISSION

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 Extension of Exemption from Inclusion of Atropine in 

Emergency Medical Kit (14 C.F.R. § 121.803(c)(3) / 14 C.F.R. Part 121, App. 

A)

Exemption No. 10736

Regulatory Docket No. FAA-2013-0188

Dear Sir or Madam:

By letter dated February 19, 2013, Frontier Airlines, Inc. (“Frontier”), petitioned the 

Federal Aviation Administration (“FAA”) for expedited and emergency approval of a limited 

exemption from 14 C.F.R. § 121.803(c)(3). That regulation requires airlines operating pursuant 

to authority 14 C.F.R. Part 119 and, therefore, under the operating requirements of 

14 C.F.R. Part 121, to carry equipment specified in Appendix A to Part 121, including an 

emergency medical kit (“EMK”). Among the items required to be included in the EMK is 

“Atropine, 0.5 mg, 5 cc (single dose ampule or equivalent).” In response to that petition, by a 

letter dated March 22, 2013 the FAA issued Exemption No. 10736 that extended the terms of 

Exemption No. 10690 to Frontier. That exemption will expire on February 28, 2014.

Frontier now respectfully requests that the exemption from carrying Atropine be 

extended by one (1) year. Frontier makes this request because of the severe nationwide shortage 

of Atropine described in its original petition continues. As was the case at the time of Frontier

original petition, that shortage has been documented by and continues to be monitored by the 

U.S. Food and Drug Administration (“FDA”).1 No estimate is provided as to when supplies will 

be restored and Atropine again readily available. Because of this, Frontier has been advised by 

its EMK provider, Banyan International, that it does not expect to be able to resume the inclusion 

 

1

See http://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm314739.htm#atropine (extract enclosed).
Petition for Extension of Exemption from Inclusion of Atropine in Emergency Medical Kit

September 30, 2013

Page 2 of 3

of Atropine in EMKs on February 28, 2014 unless and until supplies of Atropine become 

available.

Given the urgency of this matter, pursuant to 14 C.F.R. § 11.87 and, in particular, 14 

C.F.R. § 11.87(b) in that the “the relief requested is identical to exemptions granted previously” 

and 14 C.F.R. § 11.87(c) in that delay would adversely impact Frontier, Frontier requests that the 

FAA waive publication and immediately act on this exemption request.

Pursuant to 14 C.F. R. § 11.81(f) we offer the following summary of this petition:

Petitioner: Frontier Airlines, Inc. (“Frontier”)

Rule 14 C.F.R. § 121.803(c)(3) and 14 C.F.R. Part 121, App. 

A as applicable to the inclusion of Atropine, 0.5 mg, 5 cc 

(single dose ampule or equivalent) in emergency medical 

kits

Exemption 

Sought

Temporarily exempt Frontier from having to carry 

Atropine in emergency medical kits due to a chronic 

shortage of that drug

Respectfully submitted,

Brian E. Foont

Counsel for Frontier Airlines, Inc.

cc: Mr. John Allen

Director, Flight Standards Service, AFS-1

Federal Aviation Administration

800 Independence Avenue, SW

Washington, DC 20591

Mr. John Duncan

Deputy Director for Policy, Flight Standards, AFS-2P

Federal Aviation Administration

800 Independence Avenue, SW

Washington, DC 20591
Petition for Extension of Exemption from Inclusion of Atropine in Emergency Medical Kit

September 30, 2013

Page 3 of 3

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

Mr. Douglas W. Diehl

Director of Safety

Frontier Airlines, Inc.

7001 Tower Road

Denver, CO 80249

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

(reformatted)

Atropine Sulfate Injection

Company Product Availability and 

Estimated Shortage 

Duration

Related Information Shortage 

Reason

(per New 

LegislationFDASIA)*

Date 

Updated

Amphastar Pharmaceuticals 

Inc.

Customer Service:

1-800-423-4136

0.1 mg/mL, 10 mL, Luer-Jet 

Prefilled Syringe

NDC 76329-3339-1

(old NDC 00548-3339-00)

Amphastar will 

regularly release 

products.

Amphastar is experiencing a product 

shortage due to an increase in product 

demand caused by market supply 

issues.

Demand 

increase for the 

drug

Reverified

9/9/2013

Hospira, Inc.

Customer Service:

1-877-946-7747

0.1 mg/mL; 10 mL Ansyr 

syringe

(NDC 0409-1630-10)

Next delivery and 

estimated recovery 

TBD

Please check with your wholesaler for 

available inventory.

Shortage per Manufacturer:

Manufacturing delay

Other Revised

9/20/2013

0.05 mg/mL; 5 mL Ansyr 

syringe

(NDC 0409-9630-05)

Next delivery and 

estimated recovery 

TBD

0.1 mg/mL; 5 mL Lifeshield 

syringe

(NDC 0409-4910-34)

Next delivery October

Estimated recovery 4Q 

2013

0.1 mg/mL; 10 mL Lifeshield 

syringe

(NDC 0409-4911-34)

Next delivery late 

September

Estimated recovery 4Q 

2013

American Regent/Luitpold

1-800-645-1706

0.4 mg/mL, 0.5 mL ampule, 

package of 25

(NDC 00517-0805-25)

1 mg/mL, 1 mL ampule, 

package of 25 (NDC 00517-

0101-25)

Unavailable American Regent/Luitpold has 

discontinued manufacturing the 

ampoules

Discontinuation 

of the 

manufacture of 

the ampoules.

Revised

9/4/2013

0.4 mg/mL, 1 mL single-dose 

vial, package of 25

(NDC 00517-0401-25)

Unavailable American Regent is currently not 

releasing Atropine Sulfate Injection 0.4 

mg/mL, 1 mL single-dose vial 

Other

1 mg/mL, 1 mL single-dose 

vial, package of 25

(NDC 00517-1010-25)

Available American Regent is currently releasing 

Atropine Sulfate Injection 1mg/mL, 1 

mL single-dose vial Other

West-Ward Pharmaceuticals

Customer Service:

1-800-631-2174

0.4 mg/mL, 20 mL vial

(NDC 0641-6006-10)

West-Ward currently 

has limited quantities 

available on this 

product.

West-Ward has accelerated production 

to meet increased demand.

Additional lots are anticipated to be 

available in the August-September 

2013 timeframe.

Product will be made available as it is 

released.

Demand 

increase for the 

drug.

Revised

8/29/2013