C1 Flumist 20112012 IV(2).pdf

Justification for Other than Full and Open Competition for Nasal Spray Influenza Vaccine in accordance with 10 USC 2304 (c)(1)

1. The Defense Logistics Agency, Troop Support, Medical Materiel Supply Chain, is the contracting activity.

2. The action being approved is the ability to solicit for DLA requirements on an other than full and open competition basis.

3. The acquisition will result in an Indefinite Quantity Contract (IQC) for Nasal Spray Influenza Vaccine, for which a National Stock Number (NSN) has not yet, been assigned.

The required base year and option year quantities are as follows:

Year Base Year Fed. Ex. Tax Option Year Fed. Ex. Tax

Est. Oty.

180,000 PG

180,000 PG

180,000 PG

180,000 PG

Est. UP $124.00 $7.50 $130.64 $ 7.50

Total $72,802,800.00

Total Amount $22,320,000.00 $ 1,350,000.00 $23,515,200.00 $ 1,350,000.00

Maximum Oty 270,000 270,000 270,000 270,000

Total Amount $33,480,000.00 $ 2,025,000.00 $35,272,800.00 $ 2,025,000.00

The estimated quantities for the base year and option year were taken from the estimated demand, for all Services, for the 2009/2010 Flu Season. The Services have not submitted their estimated demand for the 2011/2012 or 2012/2013 Flu season. This J&A may be addended once the estimated demand for these seasons is received. Each contract year will have a guaranteed minimum of 75% of the estimated annual amount and a maximum of 150% of the estimated annual amount. These estimated dollar amounts include an allowance for a temperature monitoring device (TempTales) in the shipping container, which is a new requirement for this acquisition. The TempTales devices are required to ensure that the vaccine remains at the correct temperature.

4. The applicable statutory authority permitting other than full and open competition is 10 U.S.C. 2304(c)(1), FAR 6.302-1, only one responsible source and no other supplies or services will satisfy agency requirements.

5. This nasal spray influenza vaccine prevents disease caused by the influenza A and B virus in healthy children ages two (2) to seventeen (17) and healthy adults ages eighteen

(18) to forty-nine (49). Unlike traditional flu shots, which are made from killed viruses, the nasal spray vaccine is designed with weakened live viruses that are modified to grow in the cooler nasal passages but not in the warmer lungs, where flu develops. It helps the recipient develop immunity at the site where the flu virus typically enters the body, the nose. This vaccine is "trivalent" meaning it would include three (3) strains of the flu virus (two from influenza A virus and one from influenza B virus) because multiple strains of influenza virus circulate in the population every year. The immune response is different to each of these strains so an effective vaccine gives protection against each.

Medlmmune is the only known manufacturer of nasal spray influenza virus vaccine approved by the Food & Drug Administration (FDA). Although influenza virus vaccine is available in the injectable presentation, the Military Services require the nasal spray for that sector of the population that is averse to needle injection.

S . >rce Select:on !nfunnaUon See FAR 2 10i ;-r1o 3 i04

Justification for Other than Full and Open Competition for Nasal Spray Influenza Vaccine in accordance with 10 USC 2304 (c){1}

6. In accordance with FAR 5.2, this requirement was synopsized in FedBizOpps on November 15, 2010. In addition, this justification will be made available for public inspection, after award, in accordance with FAR 6.305.

7. As the Contracting Officer, I hereby determine that the anticipated cost to the Government will be fair and reasonable based on an analysis of other than cost and pricing data. The nasal spray is a commercial product with a commercial list price.

8. Medlmmune has been the sole manufacturer of nasal spray influe~z3 'l8ccine. A market survey was done by sending emails to vaccine suppliers V< L e-t?-4 e re:-z> -· :. All responded stating that Medlmmune is c .... ,~· "'J •. ·- Jnly FDA approved manufacturer of the Nasal Spray Influenza Vaccine. Other manufacturers have similar products in development;

however, they are still several years from FDA approval and availability to the commercial market.

9. DLA Troop Support will continue to perform market research prior to any future acquisitions for this requirement.

10. The only known source for the supply of Nasal Spray Influenza Virus Vaccine is Medlmmune. The firm has a satisfactory history of supplying this product on DoD contracts.

11. The Technical Support Branch of the Pharmaceutical Division of the Medical Supply Chain has drafted specifications for nasal spray influenza virus vaccine. These are in the form of Medical Procurement Item Descriptions (MPIDs) that contain salient characteristics and requirements. Influenza viruses change from year to year.

Consequently, the MPIDs are revised every year to be effective against the most likely strains of the virus anticipated for the upcoming flu season. As the other vaccine suppliers mentioned above obtain FDA approval, we anticipate the MPIDs will provide the basis for which potential alternate sources can be evaluated.

12. As the Contracting Officer I hereby certify that the information contained in this justification is accurate and complete to the best of my knowledge and belief.

J..- J -/I Date

, " I !\/ ,.J [l 'I -/ W- uvj :#(l.A.u:____...

NEilL McAVINUB Contracting 'Officer t::: ~

~· ~ou· · · ~; •k'r~tion Information _,_,.:, i'.H,;.. ;01 and3.104

Justification for O.:her than Full and Open Competitio-n for Nasal Spray Influenza Vaccine in accordance with 10 USC 2304 (c)(1)

I have reviewed and hereby approve this Justification.

Date Executive Director DLA Troop Support Contracting and Acquisition Management

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