Sources sought noticfe freeze dried plasma (W81XWH-20-C-0088 modification)

This Sources Sought Notice (SSN) is for market research, information, and planning purposes only and shall not be construed as a solicitation or as an obligation on the part of the United States Army Medical Research Acquisition Activity (USAMRAA) or the United States Army Medical Materiel Development Activity (USAMMDA).

This SSN is being issued by USAMRAA on behalf of USAMMDA and is seeking sources to continue providing necessary equipment, personnel, facilities, and supplies to conduct the objectives in accordance with the contract schedule and proposal titled, "Advanced Development Activities Necessary to Successfully Obtain Commercial Viability of an U.S. Food and Drug Administration (FDA) Licensed Freeze-Dried Plasma (FDP) Product.” The purpose of this contract is to conduct several activities necessary to successfully obtain and sustain commercial viability of an U.S. FDA licensed Freeze-Dried Plasma (FDP) product.

If capable sources are not identified through this notice, then USAMRAA intends to execute a level of effort and period of performance extension modification (W81XWH-20-C-0088) on a sole source basis under the authority of FAR 6.302-1 to Vascular Solutions LLC, 6464 Sycamore CT N, Maple Grove, Minnesota, 55369-6032. 

The U.S. Army has a requirement to develop, license, and sustain an FDP product in accordance with the Department of Defense (DoD) Acquisition System, U.S. FDA regulations and guidelines, and industry best practices. In direct support of the USAMMDA product development effort, the Government is seeking to obtain manufacturing support for activities necessary to sustain the commercial viability of an FDP product.  Vascular Solutions LLC is uniquely positioned to execute the necessary development activities to successfully obtain and sustain commercial viability of an U.S. FDA licensed FDP product. Vascular Solutions LLC has completed all manufacturing activities required for submission of a Biologic License Application (BLA) for FDP. Vascular Solutions LLC is the regulatory sponsor of the BLA and will manufacture, market, and distribute the FDP product. There are no other U.S. FDA approved FDP products available. The short-term requirement/increase in the level of effort will add quality management and maintenance support activities, such as supplier quality management, materials management, Blood Establishment Computer Software administration/maintenance, quality management systems and change management support, quality assurance reviews of documents/data, and equipment maintenance support. These activities support manufacturing readiness and support the BLA resubmission. If a new contract was awarded on a competitive basis to a contractor other than Vascular Solutions LLC, 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 U.S. FDA would require the new vendor to conduct validated manufacturing development and a new clinical trial specific to their product, which could take more than five years and cost $15M.

This SSN is not a request for competitive 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 information or submissions that only ask questions will not be considered as an affirmative response.  A determination by the Government not to compete based on responses to this notice is solely within the discretion of the Government.  Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement or to proceed with a sole source contract modification.

Capability statements are due by 2:00 PM local time, May 22, 2024. Capability statements shall be submitted by e-mail ONLY as a Microsoft Word or Adobe PDF attachment to the following address: bryan.g.heickman.civ@health.mil.