### T HE 

### F OONT 

### L AW 

### F IRM 

### , LLC 11909 R EYNOLDS A VENUE P OTOMAC , MD 20854

- 3334 T EL . 202

- 2 36

- 4851 / F AX . 202

- 318

- 9195 E
- M AIL : F OONT @ F OONT L AW . COM / W EB : WWW .F OONT L AW . COM
Brian E. Foont, Esq. Admitted in NY, VA, MD and DC 

### February 8, 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 Emergency 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 )
Dear Sir or Madam: Pursuant to 14 C.F.R. §§ 11.63, 11.81, and 11.87, Mesa Airlines, Inc., operating as go! , Mesa Airlines, Inc. , United Express and US Airways Express (“Mesa”) , petitions 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. Among the items required is an emergency medical kit (“EMK”) that includes

“ Atropine, 0.5 mg, 5 cc (single dose ampule or equivalent) .” Mesa respectfully requests a tempora ry, one
- year exemption from that latter requirement to carry Atropine in its EMKs

. Mesa makes this request because of a severe nationwide shortage of Atropine. This shortage has been documented by and is being monitor ed 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 , MedAire , that it will not include Atropine in EMKs after January 31, 2013. 2 

### We respectfully note that the same exemption sought here was recently granted pursuant to Exemption No. 10690 to those members of Airlines f or America, the National Air Carrier Association, and the Regional Airline Associat ion to which the same rule applies

. 3 

### As explained in the request for that exemption and recognized in the exemption that was granted, there exists a manufacturing supply shortage of Atropine leaving airlines without the means to comply with the requirement to carry that drug . The FAA also recogniz ed the rarity with which Atropine is
use d in flight and that “it is not in the public interest for EMK suppliers to airlines to be

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

. 2 See enclosed copy of memorandum from MedAire dated Januar y 28, 2013. 3 See enclosed copy of Exemption No. 10690.

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

February 8, 2013 Page 2 of 3 competing with the greater need and demand of ground

- based medical providers tor th ese medications.” Mesa respectfully submits that it is similarly situated to those carriers to which Exemption No. 10690 was granted and seek s the same exemption to avoid grounding aircraft in the event that adequate Atropine cannot be obtained. 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, Inc.,

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 Emergency Exemption from Inclusion of Atropine in Emergency Medical Kit

February 8, 2013 Page 3 of 3

Mr. Les Smith Federal Aviation Administr ation 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 Washin gton, DC 20024
Chris Pappaioanou, Esq. Vice President, General Counsel & Secretary M esa Air Group, Inc. 410 North 44th Street , Suite 700 Phoenix, AZ 85008
Enclosures

### 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

1/21/2013

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; Material shortage Other Revised 2 /1/2013

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 March Estimated recovery: 2Q 2013

0.1 mg/mL; 10 mL Lifeshield syringe (NDC 0409

- 4911

- 34) Company estimates a release date by 2Q 2013 Estimated recovery: 3Q 2013 American Regent/Luitpold 1

- 800

- 645

- 1706 0.4 mg/mL, 0.5 mL ampule, package of 25 (NDC 00517

- 0805

- 25) Unavailable Shortage per Manufacturer: American Regent/ Luitpold has discontinued manufacturing the ampules Discontinuation of the manufacture of the drug. Reverified

1/23/2013

0.4 mg/mL, 1 mL single

dose vial, package of 25 (NDC 00517

- 0401

- 25) Available American Regent is currently releasing Atropine Sulfate Injection 0.4 mg/mL, 1 mL single

- dose vial 1 mg/mL, 1 mL single

dose vial, package of 25 (NDC 00517

- 1010

- 25) Available American Regent is currently releasing Atropine Sulfate Injection 1 mg/mL, 1 mL single

dose vial 1 mg/mL, 1 mL ampule, package of 25 (NDC 00517

- 0101

- 25) Unavailable Shortage per Manufacturer: American Regent/Luitpold has discontinued manufacturing the ampules
West

- Ward Pharmaceuticals Customer Service: 1

- 800

- 631

- 2174 0.4 mg/mL, 20 mL vial (NDC 0641

- 6006

- 10) West

- Ward currently experiencing a backorder sitation. West

- Ward has accelerated

production to meet increased demand. Several lots are scheduled for production and anticipated to be available by the end of January 2013. Product will be made available as it is released. Demand increase for the drug. Revised

1/8/2013RE: Updates to labeling of Emergency Medical Kits (EMKs) and Enhanced Emergency Medical Kits (EEMKs) in regards to Atropine exemption.
Reference: U.S. Title14 CFR 121.803 Emergency Medical Equipment. Exemption No. 10690
Date: January 28, 2013

In response to the Partial Grant of Exemption issued by the FAA on January 25 regarding the requirement of Atropine, MedAire will implement the following changes to its Emergency Medical Kits and Enhanced Emergency Medical Kits.
E ffective January 31 , MedA ire will incorporate the following modifications to all new and re f urbished FAR

- compliant EMKs and EEMKs provided to U.S.

- based carriers:

1. Atropine: MedAire will discontinue the inclusion of Atropine in all medical kits that are U.S. FAR

- compliant

. 2. Med ical Kit Content Card: The Content Card will be revised to indicate the elimination of Atropine and will reference exemption notice #10690.
3. Exterior Tag: A red tag will be added to the exterior zipper indicating that the medical kit does not have Atropin e pursuant to exemption notice #10690. An example of the tag is included below.
4. Exemption Notice: A copy of the exemption notice #10690 will be inserted into the main compartment of every medical kit that does not contain Atropine.

These modificatio ns will be in effect through the duration of the Partial Grant of Exemption, which terminates on January, 31, 2014, unless sooner superseded , rescinded , or extended

. This exemption will allow MedAire to continue to provide our client carriers with new and refurbished Emergency Medical Kits and Enhanced Emergency Medical Kits that comply with FAA guidelines. MedAire will continue to provide updates as they are available. Should you have any questions, please do not hesitate to contact your account manag er. For more information about the Atropine production shortage, please visit: http://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm314739.htm#atropine

Sin cerely ,

William Mason Gary Del Vecchio Director, Commercial Aviation Vice President, Manufacturing william.mason@medaire.com gary.delvecchio@medaire.com

An example of the Exterior Tag addition.

### Exemption No

. I 0690

UNITED STATES OF AMERICA DEPARTMENT 

### O f TRANSPORT AriON FEDERAL AVIATION ADMINISTRATION WASHINGTON, DC 20591

In 

### the matter of the petition of

AIRLINES FOR AMEI{ICA NATIONAL A I R CARR I ER ASSOCIATION AND REGIONA L AIRL I NE ASSOCIATION



### for an exemption from 121

. 803 (c) (3) 

### and Part 121, Appendix A , paragraph (2) of Title 14, Code of Fede r al Regulations Regulatory Docket No
. FAA

- 2013

- 0034

PAR T IAL GRANT OF EXEMPTION


### By letter received on January 1 4,2013. Airlines for America, the National Air Carr ie r Association, and the Regional Airline Association 1301 Pennsylvania Avenue NW., Wash ington , DC 20004, petitioned the Federal Aviation Administration (FAA) on behalf of the airlines named in their petition for an exemption from 

### § 121

. 803( c )(3) 

### and Appendix A of part 121 , Title 14, Code ofF ederal Regulations. The proposed exemption , if granted, would provide relief from the requirement to include Atropine in an Emergency Medical Kit (EMK)

. The petitioners indicate they arc making this request due to a nationwide manufacturing supply shortage that leaves affected certificate holders without an alternate means to comply with the requirements of Appendix A.

The petitioners require relief from the following regulations : 

### Section 121.803(c)(3) prescribes, in pertinent part, that passenger-carrying airplanes operating under part 121 mles for which a flight attendant is required must have approved emergency medical kits that meet 

### the specifications and requirements of Part 121 , Appendix A. 

### Part 121, Appendix A , '· E mergency Medical Kits" specifies, in pertinent part, that an EMK must includ e two single dose ampules of Atropine 0.5 , Sec injectable or equivalent.

AFS-13-159

- E2

The petitioner supports its request with the following information: The petitioners state that Atropine, a medication required to be carried in EMKs, is not available due to a manufacturing shortfall and an increase in demand. One major EMK supplier has informed the petitioners that it will deplete its Atropine supply as of January 25, 2013; another indicates that its Atropine supply is already depleted. As such, the petitioners indicate that their member air carriers are not able to meet the atrop ine requirement.

The petitioners enclosed two letters from major EMK airline suppliers and refurbishers, Banyan International Corporation and MedAire. as evidence ofthe Atrop ine shortage

. The petitioners state that Banyan and MedAire are major EMK airline suppliers. The petitioners indicate that of the four pharmaceutical companies that manufacture Atropine one manufacturer has decided to stop producing Atropine and another has decided to indefinitely pos tpo ne Atropine production

. The petitioners state that this lack of production has resulted in two remaining manufacturers rationing remaining supplies to first-line responders such as hospitals and paramedic units. In addition. the letter trom Banyan states that it has verified with the Food and Drug Administration (FDA) that there are no FDA

- approved foreign Atropine manufacturers authorized to impmt Atropine into the United States to relieve the shortage. The petitioners assert that, while the FDA has the authority to extend the expiration date on drugs such as Atropine, the manufacturer must petition the FDA for an extension of the expiration date by providing drug stability data, which no manufacturer has done.

The petitioners state that MedAire has reported that roughly 1% of the EMKs returned for refurbishment (to restock an EMKs contents) are missing Atropine due to use , loss, or damage. The petitioners also state that Banyan reports that Atropine is used less th an one time per 

### 1,000 units serviced

. Finally, the petitioners request that they be able to exercise the privileges of the exemption outside the United States. They state that the International Civil Aviation O r ganization (ICAO) standards require aircraft authorized to carry more than 

### 100 passengers to be equipped with "accessible and adequate medical supplies : · but recommends that injectable Atropine be available as part of a medical kit tor use by medical doctors or other qualified persons on certain aircraft

. Accordingly. the petitioners state that the absence of Atropine in an EMK on an aircraft operating outs i de the United States would not violate ICAO requirements.

The FAA has determined that good cause exists to waive publication of a summary of this petition for exemption because delaying action would adversely affect the petitioners due to the imminent effect on operations caused by the Atropine sh011age

.3 

### The FAA's analysis is as follo w s: The FAA has con s idered fully the petitioner s' request a nd supp011ing information and finds that a prutial grant of exe mption would b e in th e public interest. All airplanes for which a fli ght atte nd ant is r equired, must car ry an EMK with it e ms listed in part 121 , Appendix A

. T h e EMK is considered a ··no-go'· i tem and is i nclud ed on the Master M i nimum Equipment List (MMEL)

. Current MMEL Policy Le tter relief requires an air carrier to repair or replace an EMK within one t li ght whe n it is incomplete, missing, or inoperati v e. There is no minimum equipment list relief permittin g an a ir carrier to depart with
an EM K m is sin g A tro pine , b eyo nd the one lli ght reli ef described in MMEL policy Letter 73 , titled "MM EL Rclieffor Emergency Medical Eq uipment."

The docume nted Atropine s hot tage create s the poss ibi li t y that a significant number of aircraft would not be able to mee t the requirements of Append ix A of part 12 1 and would have to be taken out of se r vice

. As discussed in the petit i on. EMK suppliers report that Atro pine is used for m ed ica l purposes less than one time per thousand EMK units serv i ce d , and A tropine i s predominantly replaced in EMKs due to expiration. Accor di ngly, the FAA has determined that the impact on large numb ers of passengers that would be caused by g rounding these ai rcraft for lack of Atropin e outweighs the bene 

### tit of having the medication, wh ich reporte d ly is infrequently u sed in re s ponse to on board medical e v ents.
Further, as discussed in th e petition , the nationwide Atropine shortage is affecti ng not only EMK supplier s to airlines, but a lso ground- b ased medical s er vice provide r s. The FAA also fmds th at, because this medication is reported to r a r ely be used in flight, i t is not in the p ublic interest for EMK su ppliers to airlines to be c ompe ting with the grea t er need and demand of groun d

- based medical providers to r these medications.



### The 

### FAA's Decision 

### In considera t i o n of t he foregoing, I tind that a partial grant of exemptio n i s in the public interest. Thcref()re. pursuant to the auth ority conta in ed in 49 U .S. C. 

### §§ 40113 and 44701 , delegated to me by the Admini s trator, the certificate holders listed in Condition and Limitation No

. I to thi s P artial Gran t. are granted an exem ption from 14 CFR 

### § 121.803(c)(3) and Part 12L Appendix A only to the exten t necessary to relie v e them from the requiremen t to carry two single dose ampules of Atropine Sec injectable, in required on-board EM Ks whe n, due to the nati onwide s horta ge discussed herein

. they are unable to procure th e se items for the kits. The FAA i s gra ntin g this exemption o nl y to the part 119 cettific ate holders named in the petition t hat condu ct par t 121 passenger canying ope rations.4



### Conditions and Limitations

1

. This exemption applies to the part 119 cert iiicate holders author ized to conduct part 121 passenger carrying operation s listed below.

Air Tran s port Internati o nal Expre ss Jct Republic Airlines Air Wiscon s in Airlines GoJet Ryan Interna t ional Airlines Corp

. Alaska Airlines Great Lakes Aviation Seaborne Airlines Allegiant Air Haw aiian Airlines. Inc

. Shuttle America

- ·· · -· · American Airlines Horizon Air Silver Airlines American**Ea le**  Island Air SkyWest Airlines, Inc. Atlas Air, Inc. JetBlue Airways Corp. Southwest Airl i nes, Inc. Cape Air Miam i Air International Sun Country Airlines Chatauqua Airlines N ational Airlines Trans States Airlines ConunutAir National Air Cargo United Airlines, Inc. Compass Airlines Omni Air International US Airways, Inc. Delta Air Lines, Inc. Piedmont A irline s



### - USA Jet Airlines Era Aviation Pinnacle A i rlines, Inc. World Airways Everts Air C argo PSA Airlines

2. A cop y of this exemption must be c a rri e d on board each aircraft operating with emergency medical kits that d o not include Atropine as required by Appendix A of part 121.

3. The pilot in command must inform crewmembers that any emergency medical kits
on board the aircraft may not contain Atropine as part of the pre-flight briefing.

4

. Th i s exemption may be used for flights conducted outs i de of the United States.

This exemption terminates on January 31. 20 14. unle s s sooner super s eded or rescinded.

I ssued 

### in Washington , DC , on 

### JAN 2 5 2013



# )7-J

.. 

# Mhn M. Allen D1rector, Flight Standards Service