SPECIAL NOTICE
65 -- Justification for other than full and open competition
- Notice Date
- 3/31/2014
- Notice Type
- Special Notice
- NAICS
- 325414
— Biological Product (except Diagnostic) Manufacturing
- Contracting Office
- Defense Logistics Agency, DLA Acquisition Locations, DLA Troop Support - Medical, 700 Robbins Avenue, Philadelphia, Pennsylvania, 19111-5096, United States
- ZIP Code
- 19111-5096
- Solicitation Number
- SPM2DP13R0002
- Archive Date
- 4/15/2014
- Point of Contact
- Neil Mcavinue, Phone: 215-737-3126
- E-Mail Address
-
Neil.Mcavinue@dla.mil
(Neil.Mcavinue@dla.mil)
- Small Business Set-Aside
- N/A
- Description
- 1. The purpose of this Addendum is to correct numbered paragraph 6 in the subject Justification. 2. The Justification will not be published "with the solicitation" as stated. This is the case with a brand name justification, but the Intranasal Vaccine has a specification with essential characteristics, and no particular brand name is specified. The Justification will be published after award of the contract in accordance with FAR 6.305(a). I hereby certify that the above addendum is accurate and complete to the best of my knowledge and belief. _____________ Neil McAvinue Contracting Officer 1. Defense Logistics Agency (DLA) Troop Support, Medical Supplier Operations, is the contracting activity. 2. The action submitted for approval 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 Intranasal Influenza Vaccine. The sole source for these items is MedImmune. The maximum value for a base year contract with one option year is [redacted]. The supplies and estimated quantities for the base year and one year option are as follows: Base year Est. Qty. Max. Qty. Est. UP Total Maximum Amount Vaccine 140,000 PG 180,000 [redacted] Excise Tax 140,000 EA 180,000 7.50 $ 1,350,000.00 Option Year Vaccine 140,000 PG 180,000 [redacted] Excise Tax 140,000 EA 180,000 7.50 $ 1,350,000.00 Total [redacted] The estimated quantities for the base year and option year are based on current orders placed by all Services for the 2012 flu season. The actual demands (reported in March) may decline, in which case the solicitation will be amended accordingly. The base year will have a guaranteed minimum of 75% of the estimated annual amount. The option year will have a guaranteed minimum of 60% to allow for potential declining demands. The maximum amount of 180,000 is used in the event of unexpected demands and is consistent with the demand levels seen in prior years. The price estimates were based on a current contract price of $121.10/PG, under contract SPM2DP-11-D-0008. MedImmune maintained this same price for the basic and option periods. These estimated prices are exclusive of the Federal Excise Tax (FET); however, the total amount is inclusive of the FET in order to show the total anticipated Government obligation. 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. The Intranasal Influenza Vaccine is intended for active immunization of disease caused by influenza viruses in healthy individuals ages 2 through 49. Unlike traditional flu shots, which are made from killed viruses, the Intranasal 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. For the 2013-2014 flu seasons, MedImmune has FDA approval to market a quadrivalent flu vaccine, which means it will include four different strains of the flu virus. Multiple strains of influenza virus circulate in the population every year and the immune response is different to each of these strains, so an effective vaccine gives protection against each. MedImmune, which is a division of AstraZeneca, is the only known manufacturer of the Intranasal Influenza Vaccine. The vaccine is patented and marketed under the brand name "Flumist". It is the only known intranasal vaccine approved by the FDA. The Intranasal Vaccine is considered necessary for that sector of the population that is averse to needle injection. Influenza Virus Vaccine is available in the injectable presentation; however the military services require both the intranasal and the injectable presentations, especially in the event of occasional batch failures which may cause vaccine shortages. 6. In accordance with FAR 5.2, this requirement was synopsized in FedBizOpps. In addition, this justification will be published with the solicitation in accordance with FAR 6.305(c). 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 Intranasal is a commercial product with a commercial list price and it is sold in substantial quantities to the general public through wellness clinics and pharmacies. Also, MedImmune's price is currently subject to a "Federal Ceiling Price" that is negotiated between MedImmune and the Dept. of Veterans Affairs. By this agreement the price ceiling applies to all Government agencies. 8. MedImmune has been the sole manufacturer of an intranasal type vaccine since the introduction of the product in 2003. Additional market research was limited to sending emails to several vaccine suppliers and asking if they are aware of any new developments in this type vaccine delivery device. All responses affirmed that MedImmune is still the only known source for an intranasal vaccine. 9. The DLA Troop Support Pharmaceutical Distribution IST in coordination with the Military Vaccine Agency at Ft Detrick, Maryland will continue to perform market research prior to any future acquisitions for the requirement. 10. The only known source for the supply of Intranasal Influenza Virus Vaccine is MedImmune of Gaithersburg, Maryland, which has continually expressed interest in fulfilling the Government's requirements for this type of vaccine. 11. The Government has minimal ability to effect competition in the production of an intranasal flu vaccine. The MedImmune product is under patent. Any manufacturer must undergo extensive product testing to meet the requirements of FDA licensure, a process that can take years. In an effort to foster competition, however, the Government has produced a specification with essential characteristics and will advertise the requirements as stated in paragraph 6 above. In accordance with FAR 6.302-1(d)(2), any proposal in response to this notice will be considered. 12. The undersigned Contracting Officer hereby certifies that the information contained in this justification is accurate and complete to the best of his knowledge and belief. _____________ Date NEIL McAVINUE Contracting Officer I have reviewed and hereby approve this Justification. _________________________ Date WILLIAM J. KENNY Executive Director Contracting and Acquisition Mgmt. DLA Trop Support
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/DLA/J3/DSCP-M/SPM2DP13R0002/listing.html)
- Record
- SN03324843-W 20140402/140331234650-7a55e98c1488ce14a494e058ac9b222a (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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