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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 intends to award a sole-source contract to Vascular Solutions LLC for Product Lifecycle Management activities required to sustain the commercial viability of a Single Donor, Type Specific, Universal Freeze-Dried Plasma product. This requirement, identified under solicitation number HT942726RE014, supports the Portfolio Acquisition Executive Medical Products in the development, licensing, and sustainability of the product in accordance with U.S. Food and Drug Administration regulations and Department of War Acquisition System guidelines. Performance is centered in Frederick, Maryland, 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, and Experimental Development. There is no set-aside designated for this action.
The rationale for the sole-source award is based on the vendor’s unique position as the regulatory sponsor of a Biologics License Application currently under review by the FDA. As there are no other FDA-approved dried plasma products available, the government has determined that awarding to another source would result in unacceptable delays and duplicative costs exceeding $15 million due to the necessity of new clinical trials and manufacturing development. The scope of work includes manufacturing, marketing, and distribution activities necessary to maintain the product's commercial sustainability.
While this notice is not a request for competitive proposals, interested parties may submit capability statements to demonstrate their ability to satisfy the requirement. Responses must include technical, management, and cost data across no more than five pages and are due by 2:00 p.m. local time on June 22, 2026. Submissions must be sent electronically to Toloria DuVall and Shannon Lertora. The government will use the received information to determine whether to proceed with the sole-source award or initiate a competitive procurement.
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