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11909 R EYNOLDS A VENUE P OTOMAC , MD 20854

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- M AIL : F OONT @ F OONT L AW
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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. 10716

Regulatory Docket No. FAA

- 2013

- 0135

Dear Sir or Madam: By letter dated February 8, 2013, Mesa Airlines, Inc., oper ating as go! , Mesa Airlines, Inc., United Express and US Airways Express (“Mesa”), 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 a irlines 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 8, 2013 the FAA issued Exemption No. 10716 that extended the terms of Exemption No. 106 90 to Mesa. That exemption will expire on February 28, 2014. Mesa now respectfully requests that the exemption from carrying Atropine be extended by one (1) year

. Mesa makes this request because of the severe nationwide shortage of Atropine described in it s original petition continues

. As was the case at the time of Mesa original 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, Mesa has been advised by its EMK provider

,

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

MedAire

, that it does not expect to be able to resume the inclusion of Atropine in EMKs on February 28, 2014 unless and until supplies of Atropine be come 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 Mesa

, Mesa 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 s ummary of this p etition:

Petitioner: Mesa Airlines, Inc., operating as go! , Mesa Airlines, I nc.,

United Express and US Airways Express (“Mesa”)

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 Mesa from having to carry Atropine

in emergency medical kits due to a chronic shortage of that drug

Respectfully submitted

,

Brian E. Foont Counsel for Mesa 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 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’Enfa nt Plaza, SW Washington, DC 20024

Chris Pappaioanou, Esq. Vice President, General Counsel & Secretary Mesa Air Group, Inc. 410 North 44th Street, Suite 700 Phoenix, AZ 85008

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 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 ch eck 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