November 5, 2013 

Sent electronically, original via Fed Ex 

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. 1 0706 

Regulatory Docket No. FAA-2013-0118 

Dear Sir or Madam: 

By letter dated February 1, 2013, Sierra Pacific Airlines, Inc. 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 February 14, 2013, the FAA issued 

Exemption No. 10706 that extended the terms of Exemption No. 1 0690 to Sierra Pacific 

Airlines. That exemption will expire on February 28, 2014. 

Sierra Pacific Airlines now respectfully requests that the exemption from ·carrying 

Atropine be extended by one (1) year. Sierra Pacific Airlines 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 Sierra Pacific Airlines' 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, Sierra Pacific Airlines 

has been advised by its EMK provider, MedAire, that it does not expect to be able to 

1 See http:l/www.fda.gov/Drugs/DrugShortages/ucm314739.htm#atropine (extract enclosed). 

7700 North Business Park Drive • Tucson, Arizona 857 43-9622 • (520) 7 44-1144 • FAX: (520) 7 44-0138 
Petition for Extension of Exemption from Inclusion of Atropine in Emergency 

Medical Kit 

November 5, 2013 

Page 2 of2 

resume the inclusion 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 relief requested is identical to exemptions granted 

previously" and 14 C.F.R. § 11.87(c) in that delay would adversely impact Sierra Pacific 

Airlines. Sierra Pacific Airlines 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: 

Rule 

Exemption 

Sought 

Sierra Pacific Airlines, Inc. 

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 (EMK) 

Temporarily exempt Sierra Pacific Airlines from having to 

carry Atropine in emergency medical kits due to a chronic 

shortage of that drug 

Respectfully submitted November 5, 2013 by: 

ToddA. Watkins 

Director of Maintenance 

Sierra Pacific Airlines, Inc. 

7700 N. Business Park Drive 

Tucson, AZ. 857 43-9622 

520-7 44-9400 ext. 22 

twatkins@sierrapacificairlines.com 

Enclosure 
I 

From http://www. fda.gov /Drugs/DrugSafety/DrugShortages/ucm314 73 9 .htm#atropine 

(reformatted) 

Atropine Sulfate Injection 

-•••c _,_ ·····~ - Company 

I 

Product Availability and Related Information Shortage I 

Estimated Shortage Reason 

Duration (per New 

Legislation-

-~-- .. -- FDASIA)• 

Amphastar Pharmaceuticals 0.1 mglmL, 10 mL, Luer-Jet Amphastar will Amphastar is experiencing a product Demand 

Inc. Prefilled Syringe regularly release shortage due to an increase in product increase for the 

Customer Service: products. demand caused by market supply drug 

1-800-423-4136 issues. 

' 

NDC 76329-3339-1 I 

! (old NDC 00548-3339:?0) 

Hospira, Inc. 0.1 mg/mL; 10 mL Aosyr Next delivery and ' Please check with your wholesaler for Other 

Customer Service: syringe estimated recovery . available inventory. 

1-877-946-7747 ~ (NDC 0409-1630-10) TBD 

0.05 mglmL; 5 mL Ansyr Next delivery and Shortage per Manufacturer: syringe estimated recovery Manufacturing delay 

(NDC 0409-9630-05) TBD 

Next delivery October 

0.1 mg/mL; 5 mL Lifeshield 

syringe 

(NDC 0409-491 0-34) Estimated recovery 4Q 

2013 -·-- -- I Next delivery late 

0.1 mg/mL; 10 mL Lifeshield September 

' . I syrmge 

(NDC 0409-4911-34) Estimated recovery 4Q I 

2013 

American Regent/Luitpold 0.4 mg/mL, 0.5 mL ampule, Unavailable American Regent/Luitpold has Discontinuation 

1-800-645-1706 package of 25 discontinued manufacturing the of the 

(NDC 00517-0805-25) ampoules manufacture of 

the ampoules. 

I 

I 

I mg/mL, I mL ampule, 

package of25 (NDC 00517-

, ~'?'~:,s) --- ---- -- ----- .. 

~: 0.4 mg/mL, I mL single-dose Unavailable American Regent is currently not 

vial, package of 25 releasing Atropine Sulfate Injection 0.4 

(NDC 00517-0401-25) mg/mL, I mL single-dose vial 

I mg/mL, I mL single-dose Available , American Regent is currently releasing F' I vial, package of 25 Atropine Sulfate Injection lmg/mL, I 

, (NDC 00517-1010-25) ! mL single-dose vial 

West-Ward Pharmaceuticals 0.4 mg/mL, 20 mL vial West-Ward currently West-Ward has accelerated production Demand 

Customer Service: 1 (NDC 0641-6006-10) has limited quantities to meet increased demand. increase for the 

1-800-631-2174 available on this drug. 

product. 

Additional lots are anticipated to be 

available in the August-September 

I 2013 time frame. 

I 

Product will be made available as it is I ' I released. 

-

- Date 

Updated 

Reverified 

9/912013 

Revised 

9/20/2013 

Revised 

9/4/2013 

Revised 

8/29/2013