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11909 R EYNOLDS A VENUE P OTOMAC , MD 20854

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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. 1073 6

Regulatory Docket No. FAA

- 2013

- 01 88

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, there fore, 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 t he FAA issued Exemption No. 1073 6 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 origina l petition, t h at 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 h as 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 3 0 , 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, p ursuant 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 an d immediately act on this exemption request. Pursuant to 14 C.F. R. § 11.81(f) we offer the following s ummary of this p etition:

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 du e 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 Ave nue , SW Washington, DC 20591

## Petition for Extension of Exemption from Inclusion of Atropine in Emergency Medical Kit

September 3 0 , 2013 Page 3 of 3

Mr. Les Smith Federal Aviation Administration Flight Standards Service Air Transport Division, A FS

- 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 a nd Estimated Shortage Duration Related Information Shortage Reason (per New Legislation

FDASIA)* 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

r eleasing 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