Notice of Intent to Sole Source for Single Donor, Type Specific, Universal Freeze-Dried Plasma Activities for Commercial Sustainabilityview on SAM.gov

This is a Notice of Intent (NOI) to Sole Source on the basis of other than full and open competition. This is not a Request for Quotes or Proposals. The purpose of this notice is to allow interested parties to assert and explain their capability to satisfy the requirement described. The Defense Health Agency Contracting Activity (DHACA) Medical Research & Development Contracting Division 2, in support of the Defense Health Agency (DHA) Portfolio Acquisition Executive (PAE) Medical Products, intends to execute a contract on a sole source basis under the authority of the Revolutionary FAR Overhaul (RFO) FAR 6.103-1 to Vascular Solutions LLC, 6464 Sycamore CT N, Maple Grove, Minnesota, 55369-6032 (a subsidiary of Teleflex LLC), which will develop, license, and sustain a Freeze-Dried Plasma (FDP) product in accordance with the Department of War (DoW) Acquisition System, U.S. Food and Drug Administration (FDA) regulations and guidelines, and industry best practices. In direct support of the PAE's product development effort, the Government is seeking to obtain Product Lifecycle Management (PLM) activities necessary to sustain the commercial viability of a FDP product. Vascular Solutions is uniquely positioned to execute the necessary PLM activities required to sustain the commercial viability of a FDP product. Vascular Solutions re-submitted FDP Biologics License Application (BLA) to the FDA and continues to complete the required activities as requested by the FDA during Pre-Approval Inspection and BLA review. Vascular Solutions will be the regulatory sponsor of the BLA and will manufacture, market, and distribute the Single Donor, Type Specific, Universal FDP product. There are no other FDA approved Dried Plasma products available. Vascular Solutions' FDP product is the only Single Donor, Type Specific, Universal product with a BLA in review by the FDA. If a contract was awarded on a competitive basis to a contractor other than Vascular Solutions the FDP program would incur unacceptable delays and incur duplicative costs as the previously conducted manufacturing development and clinical trial would no longer be valid. The FDA would require the new vendor to conduct validated manufacturing development and a new clinical trial specific to their product, which could take in excess of 5 years and cost $15-$20M. This NOI is not a request for competitive quotes/proposals, and no solicitation document exists for the requirement. Sources interested in responding to this notice are required to submit a capability statement that includes management and technical data and cost information, in sufficient detail and with convincing evidence that clearly demonstrates the capability to perform the required work. Capability statements shall not exceed five (8.5 x 11 inch) pages using a font size no smaller than 10-point. The Government will consider all capability statements received by the due date of this notice. A request for documentation or additional informatio…