### November 5, 2013 Sent electronically, original via FedEx U.S. Department ofTransportation 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. 10706 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. 10690 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 ofthe severe nationwide shortage ofAtropine 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 expectto be able to

1 See http:l/www.fda.gov/Drugs/DrugShortages/ucm314739.htm#atropine (extract enclosed). 7700 NorthBusiness Park Drive • Tucson, Arizona 85743-9622 • (520) 744-1144 • FAX: (520) 744-0138

### 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 ofAtropine become available. Given the urgency ofthis 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. · Pursuantto 14 C.F.R. 

### § 11.81

### (f) we offerthe following summary ofthis petition: Petitioner: Rule

Exemption Sought Sierra PacificAirlines, Inc. 14 C.F.R. 

### § 121.803(c)(3) and 14 C.F.R. Part 121, App. A as applicable to the inclusion ofAtropine, 0.5 mg, 5 cc (single dose ampule orequivalent) in emergency medical kits (EMK) Temporarily exempt Sierra PacificAirlines from having to carry Atropine in emergency medical kits dueto a chronic shortage ofthat drug Respectfully submitted November 5, 2013 by:

ToddA. Watkins Director ofMaintenance Sierra PacificAirlines, Inc. 7700 N. BusinessPark Drive Tucson, AZ. 85743-9622 520-744-9400 ext. 22 twatkins@sierrapacificairlines.com Enclosure

# I Fromhttp://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm314739.htm#atropine (reformatted) AtropineSulfate Injection

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### - Company 

# I Product Availability and Related Information Shortage I Estimated Shortage Reason Duration (perNew Legislation-**-~--** .. -- FDASIA)• Amphastar Pharmaceuticals 0.1 mglmL, 10 mL, Luer-Jet Amphastarwill Amphastaris experiencing aproduct Demand Inc. Prefilled Syringe regularly release shortage due to an increase inproduct increase for the CustomerService: products. demand causedby market supply drug 1-800-423-4136 issues. ' NDC 76329-3339-1 I !(oldNDC 00548-3339:?0) Hospira, Inc. 0.1 mg/mL; 10 mL Aosyr Next deliveryand ' Please check with yourwholesaler 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 perManufacturer: syringe estimatedrecovery Manufacturing delay (NDC 0409-9630-05) TBD Nextdelivery October 0.1 mg/mL; 5 mL Lifeshield syringe (NDC 0409-4910-34) Estimatedrecovery4Q 2013

-·-- 

### -- I Nextdelivery late 0.1 mg/mL; 10 mL Lifeshield September I '

. syrmge (NDC 0409-4911-34) Estimated recovery4Q I 2013 American Regent/Luitpold 0.4 mg/mL, 0.5 mL ampule, Unavailable American Regent/Luitpold has Discontinuation 1-800-645-1706 package of25 discontinued manufacturing the ofthe (NDC 00517-0805-25) ampoules manufacture of the ampoules.

I I I mg/mL, I mL ampule, package of25 (NDC 00517-

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# ~: 0.4 mg/mL, I mL single-dose Unavailable American Regent is currentlynot vial, package of25 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' Ivial, package of25 Atropine SulfateInjection 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 anticipatedtobe available inthe August-September I 2013 timeframe.

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Productwill be made available as it is 

# I ' released. I

- - Date Updated

Reverified 9/912013

Revised 9/20/2013

Revised 9/4/2013

Revised 8/29/2013