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Notice of Intent to Sole Source for Single Donor, Type Specific, Universal Freeze-Dried Plasma Activities for Commercial Sustainability
Contact and place of performance
Toloria DuVall
Frederick, MD 21702
USA
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 Defe...
View moreThis 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 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 award.
Capability statements should appear on company letter-head and includes affirmation of active registration in the System of Award Management (SAM), your qualifications and any other applicable data or information. Additionally, respondents should indicate whether they are a large business, small business, small-disadvantaged business, 8(a)concern, woman-owned small business, HUBZone, service-disabled veteran-owned small business, or qualify as socially or economically disadvantaged.
Your response to this NOI, including any capabilities statement, shall be electronically submitted to Toloria DuVall at [email protected] and Shannon Lertora at [email protected] in either Microsoft Word or Portable Document Format (PDF), no later than (NLT) 2:00 p.m. local time on 22 June 2026. Your response shall reference this Notice ID number (HT942726RE014) in the subject line of your e-mail and on all enclosed documents. All data received in response to this NOI that is marked or designated as corporate or proprietary will be fully protected from any release outside of the Government. Responses to this notice will be used to determine the availability of this type of product and/or service. All responsible sources may respond to this notice, and all responses will be considered by the agency.
The Defense Health Agency Contracting Activity (DHACA) Medical Research & Development Contracting Division 2, supporting the Defense Health Agency (DHA) Portfolio Acquisition Executive (PAE) Medical Products, intends to award a sole-source contract to Vascular Solutions LLC. Located in Maple Grove, Minnesota, Vascular Solutions is a subsidiary of Teleflex LLC and is tasked with developing, licensing, and sustaining a Single Donor, Type Specific, Universal Freeze-Dried Plasma (FDP) product. The scope of work involves Product Lifecycle Management (PLM) activities necessary to maintain the commercial viability of the product in accordance with Department of War (DoW) Acquisition System standards and U.S. Food and Drug Administration (FDA) regulations.
This requirement is classified under NAICS code 541715 for Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology) and PSC AN13 for Health R&D Services; Health Care Services; Experimental Development. There is no set-aside designated for this effort, denoted as NONE. Vascular Solutions is the regulatory sponsor of the Biologics License Application (BLA) currently under FDA review and will manufacture, market, and distribute the product. The government has identified this vendor as uniquely qualified because no other FDA-approved dried plasma products exist, and a competitive award to another contractor would result in estimated delays of over five years and duplicative costs ranging from $15 million to $20 million for new clinical trials and manufacturing validation.
Performance will take place in Frederick, Maryland, under solicitation number HT942726RE014. While this is a notice of intent to sole source rather than a request for proposals, interested parties may submit capability statements by June 22, 2026, at 2:00 p.m. local time. Submissions are limited to five pages and must demonstrate the technical and management capability to satisfy the requirement. All responses will be used to determine whether to proceed with the sole-source award or initiate a competitive procurement.
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