### T HE 

### F OONT 

### L AW 

### F IRM 

### , LLC

11909 R EYNOLDS A VENUE P OTOMAC , MD 20854

- 3334
T EL

. 202

- 236

- 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 22 , 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 Dextrose 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 under 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 “ Dextrose, 50%/50 cc injectable, ( single dose ampule or equivalent) ” (“Dextrose”). Mesa respectfully requests a tempora ry, one

- year exemption from that latter requirement to carry Dextrose in its EMKs and to substitute Glucagon 1mg

. Mesa makes this request because of a severe nationwide sh ortage of Dextrose . This shortage has been documented by and is being monitored by the U.S. Food and Drug Administration (“FDA”). 1
Because of this, Mesa has been advised by its EMK provider

, MedAire

, that it will no longer stock
Dextrose in EMKs , and will “re

- furbish only those used and expired medical kits which still contain Dextrose that has not yet expired. In these cases, the kits will be usable for only the period of time in which the existing Dextrose is usable

– dating that varies from 1 to 11 months. ” 2 MedAire further notes (emphasis added):

The manufacturers have indicated that they will begin distributing the drug again sometime in February and anticipate that availability will meet demand sometime in Q2 2013. This timeline is dynamic, however, and once distribution begins again, distribution is at the discretion of the manufacturer. The typical distribution will be to first line medical facilities and emergency response units and finally to suppliers such as MedAire. To that end, we anticipate that this shortage may extend to the end of Q2 2013 or longer.

Thus, Mesa cannot reliably determine when Dextrose will again be dependably available for the restocking of its EMKs.

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

. 2 See enclosed copy of memorandum from MedAire dated February 21, 2013.Petition for Emergency Exemption from Inclusion of Dextrose in Emergency Medical Kit

February 22 , 2013 Page 2 of 3

As an alternative to Dextrose, MedAire notes in the attached letter that there are “two acceptable equivalent medications for the Dextrose 50%/50 cc (single dose ampule or equivalent).” They are: (1) Glucagon 1mg, and (2) Dextrose 25% (2 doses) . Because there is also a shortage of the latter, Mesa proposes to substitute Gl ucagon 1mg for Dextrose.

MedAire notes that use of both Dextrose and Glucagon 1mg (which they note some carriers stock) is quite rare . Specifically, they note that in 2012 use of both was made in less than 0.02% of the approximately 25,000 cases in which MedAire was contacted for in

- flight emergency medical
consultations

, i.e. , less than 5 times

. We respectfully note that a similar exemption was sought for the then members of Airlines f or America (then the Air Transport Association of America) , the National Air Carrier Association, and the Regional Airline Association in August 10, 2 010 (Docket No. FAA

- 2010

- 0832)

. 3 That request was, however, withdrawn on November 10, 2010 because supplies had been restored.

Given the urgency of this matter, p ur suant to 14 C

. F

. R

. § 11.87 and, in particular, 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. We respectfully further note that, because the reques t discussed above under Docket No. FAA

- 2010

- 0832 was published in the Federal Register for comment, 4 the public has, in fact, had an opportunity to comment on this issue.

Pursuant to 14 C.F. R. § 11.81(f) we offer the following s ummary of this p etition:

Pe titioner: 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 Dextrose, 50%/50 cc injectable, (single dose ampule or equivalent) in emergency medical kits

Exemption Sought Temporarily exempt Mesa from having to carry Dextrose,

50%/50 cc injectable, (single dose ampule or equivalent) in emergency medical kits due to a chronic shortage of that drug
and allo w the substitution of Glucagon 1mg.

Respectfully submitted

,

Brian E. Foont
Counsel for Mesa Airlines, Inc.

3 T hat request also sought an exemption with respect to Epinephrine 1:10,000, 2 cc, injectable, (single dose ampule or equivalent), which is not at issue in the present case

4 75 Fed. Reg. 51,525 (Aug. 20, 2010).Petition for Emergency Exemption from Inclusion of Dextrose in Emergency Medical Kit

February 22 , 2013 Page 3 of 3

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

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

- 200
8 00 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. Deke Abbott Supervisory Aviation Safety Inspector Air Carrier Operations
Federal Aviation Administration 800 Independence Ave., SW
Room 829 / Desk C

- 52 Washington, DC 20591

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

EnclosuresFrom http://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm314739.htm#dextrose

(reformatted)

Dextrose Injection (Initial posting

– 5/23/2012)

Company Product Availability
and
Estimated Shortage
Duration Related

Information Shortage

Reason (per New Legislation

FD ASIA)* Date

Updated

Amphastar Pharmaceuticals,
Inc.
Customer
Service:
1

- 800

- 423

- 4136 50%, 50mL

Luer

- Jet
Prefilled Syringe

NDC 76329

- 3301

- 1

(old NDC 0548

- 3301

- 00) Amphastar

will regularly
release products Amphastar is

experiencing a product shortage due

to an increase in product demand caused by market supply issues.

Shortage per
Manufacturer:
Increased Demand Demand

increase for the drug. Reverified

2/11/2013

Hospira, Inc.
Customer
Service
1

- 877

- 946

- 7747 50%; 50mL vial

(NDC 00409

- 6648

- 02) Next

delivery February
Estimated recovery 2Q
2013 Shortage per

Manufacturer:

Manufacturing delay Other Revised
2/1/2013

50%; 50mL Abboject Syringe (NDC
00409

- 4902

- 34) Next

delivery February
Estimated recovery 2Q
2013

50%; 50mL Ansyr Syringe (NDC 00409

- 7517

- 16) Next

delivery January
Estimated recovery 2Q
2013February 21, 2013

Dear Sir or Madame,

MedAire produces FAR-compliant medical kits for your airline subject to Part 121 requirements.

Recent pharmaceutical manufacturing c hanges have reduced t he availability of Dextrose. Dextrose 50%, inj. 50 mL is an FAA-required component for onboard medical kits according to 14 CFR Part 121.803, Appendix A.

As of February 20, MedAire has depleted its supply of Dextrose. Should your carrier request new medical kits, or r equest refurbishment of existing medical kits with expired or missing Dextrose, MedA ire will be unable to prov ide FAR-compliant kits.

Beginning today, we are coordinating with your carrier to re-furbish only those used and expired medical kits which st ill contain Dextrose that has not yet expired. In these cases, the kits will be usable fo r only the period of time in wh ich the existing Dextrose is usable—dating that varies from 1 to 11 mont hs. For kits containing expired Dextrose, we are not able to refurb ish them at this time.

The manufacturers have indicated that th ey will begin distributing the drug again sometime in February and antici pate that availability will meet demand sometime in Q2 2013. This timeline is dynamic, however, and once distribution begins again, distribution is at the discretion of the manufacturer. T he typical distribution will be to first line medical facilities and emergency response units and finally to suppliers such as MedAire. To that end, we ant icipate that this shortage ma y extend to the end of Q2 2013 or longer.

For additional information about the Dextrose production shortage, please refer to the following links: http://www.fda.gov/Drugs/DrugSafet y/DrugShortages/ucm 314739.htm#dextrose http://www.ashp.org/DrugShortage s/Current/bulletin.aspx?id=988Based on a formal review by MedAire’s Medi cal Equipment Review Board, there are two acceptable equivalent medications for t he Dextrose 50%/50 cc (single dose ampule or equivalent) requirement:

• Glucagon 1mg-- Although not an identical product, gl ucagon 1 mg will achieve similar results in the majority of the popul ation by raising the blood glucose levels in passengers with severe hypoglycemia.

• Dextrose 25% [2 doses]. Note: There is also currently a shortage of Dextrose
25%.

MedAire supports airlines with in-flight medical advisory services, assisting with approximately 25,000 events each year. A recent review of data from 2012 suggests that .02% of in-flight case s were serious enough to call for use of Glucagon [which some airlines stock] or Dextrose-- the nec essary intervention to manage the medical emergency. It should be noted that these dr ugs are indicated in cases of severe hypoglycemia which although uncomm on could be life-threatening.

Please let us know if we can pr ovide any additional information.

Sincerely,

Heidi MacFarlane

Vice President, Strategic Development MedAire, an International SOS company Paulo Alves, MD, MSc, FAsMA

Vice President, Aviation and Maritime Health MedAire, an International SOS company