Meningitis B Vaccine Acquisition
The Centers for Disease Control and Prevention, NCIRD/ISB, 1600 Clifton Rd. NE, Atlanta, GA, 30333, hereby announces its intent to issue a sole source contract in accordance with FAR 6.302-1 to Novatris Vaccines and Diagnostics, 4560 Horton Street, Emeryville, CA 94608, to procure, store, and ship Bexsero® (rMenB+OMV NZ) vaccine.
The statutory authority permitting other than full and open competition is 41 U.S.C. 253(c)(1) as cited in FAR 6.302-1, "Only one responsible source and no other supplies or services will satisfy agency requirements." Novartis is the only contractor that manufactures this vaccine. Due to their unique position as the manufacturer of the vaccine and in order to assure the maximum available shelf-life for CDC's vaccines (at least until November 2015), the vaccines must remain in the possession of the manufactuer. Further, there is not currently a licensed vaccine for serogroup B (MenB) meningococcal disease in the US; however, the investigational Men B vaccine is currently under development by Novartis Vaccines. This vaccine has recently been granted a Breakthrough Therapy dsignation by the Food and Drug Administration (FDA). Until a licensed Men B vaccine is available in the US, use of an unlicensed vaccine under a CDC-sponsored Investigational New Drug (IND) protocol is necessary to control MenB outbreaks. The goal is to maintain a minimum shelf-life of 12 months on the vaccines in order to ensure readiness to deploy the stockpile for disease response. As the manufacturer, Novartis is the only vendor with a market large enough to produce, store, and ship the stockpiled vaccines to maintain a viable stockpile.
Responsible sources that believe they possess the expertise and capabilities identified above are encouraged to submit to the Contracting Officer within 7 days from the posting date of this notice, their written capabilities statement, proposal or quotation which shall be considered by the agency. Please forward the capability statement and/or pricing information to David Dombeck, Contracting Specialist, Reference 2014-73803, Centers for Disease Control, Procurement and Grants Office, ATTN: David Dombeck, MS: K-14, 2920 Brandywine Road, Atlanta, GA 30341. All vendors must be registered in the System for Award Management (SAM) prior to an award of a federal contract. The website is: www.sam.gov.
The Government will review any/all capabilities statements and pricing information submitted and determine if other qualified sources do exist that could provide this requirement. Information received in response to this announcement will be used solely for the purpose of determining whether to conduct a competitive procurement.
If no affirmative responses are received within 7 days, negotiations will be conducted with the Novartis, as the only source and a contract will be issued without any additional notices being posted.
David S Dombeck, Contract Specialist, Phone 7704882635, Email [email protected]
