Notice of Intent to Sole Source - EzPlaz
Closed Special Notice Posted
- Solicitation number
- HT942726QE015
- Agency
- Not on record
- Responses due
- Set-aside
- No set-aside
Opportunity facts
- NAICS code
- 325412 Pharmaceutical Preparation Manufacturing
- PSC
- 6505 Drugs And Biologicals
- Place of performance
- Maryland 21702, United States
Notice details come from SAM.gov. Updated .
About this opportunity
The Defense Health Agency Contracting Activity issued a Notice of Intent to sole-source an Indefinite Delivery/Indefinite Quantity firm-fixed-price contract to Vascular Solutions LLC for supply of FDA-approved Freeze Dried Plasma (EZPLAZ) with a response deadline of September 16, 2026. DHA determined that Vascular Solutions LLC is the only responsible source capable of meeting requirements, citing the company's exclusive hold on the first and only FDA-approved licensed FDP product on the market, which the FDA approved on July 29, 2026. The sole-source authority invoked is FAR 6.103-1, based on a critical Government requirement for FDA-approved FDP product for transfusion when other plasma products are unavailable.
Despite the stated sole-source intent, the notice solicits capability statements from sources interested in responding. Capability statements must not exceed 5 pages (8.5 by 11 inches, 10-point font minimum) and shall include management, technical, and cost information with clear and convincing evidence demonstrating capability to provide FDA-approved FDP product. The Government will consider all capability statements received by the due date. Requests for documentation or information that only pose questions will not be treated as affirmative responses. The Government's decision not to compete is solely discretionary based on responses received.
NAICS 325412 (Pharmaceutical Preparation Manufacturing); PSC 6505 (Drugs and Biologicals).
Notice text
The Defense Health Agency (DHA) Contracting Activity (DHACA), on behalf of the DHA’s Portfolio Acquisition Executive Medical Products (PAE MP), intends to issue a firm-fixed price Indefinite Delivery/Indefinite Quantity contract on a sole source basis under the authority of the Revolutionary Federal Acquisition Regulation (FAR) Overhaul, FAR 6.103-1, only one responsible source and no other supplies or services will satisfy agency requirements, to Vascular Solutions LLC, 6420 Sycamore Ct N, Maple Grove, Minnesota 55369-6032.
Vascular Solutions, LLC is the only source able to meet the Government’s requirements. The Government has a has a critical requirement for supply of a Food and Drug Administration (FDA) approved Freeze Dried Plasma (FDP) product for transfusion when plasma is required and other plasma products are not available. The FDA approved Vascular Solutions, LLC FDP product, EZPLAZ™, on 29 July 2026. Vascular Solutions LLC holds the first and only FDA-approved (licensed) FPD product on the market.
This Notice of Intent 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. Responses must be supported with clear and convincing evidence articulating the ability to provide FDA approved FDP product. Capability statements shall not exceed 5 (8.5 x 11 inch) pages using a font size no smaller than 10-point. All capability statements received by the due date of this notice will be considered by the Government. 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. If no written responses are received by the date listed below, an Indefinite Delivery/Indefinite Quantity contract will be awarded without further remark.
Capability statements are due by 3:00 PM local time, 16 September 2026. Capability statements shall be submitted by e-mail ONLY as a Microsoft Word or Adobe PDF attachment to the following address: timothy.j.kelly169.civ@health.mil and shannon.p.lertora.civ@health.mil.
Notice history
| Notice | Type | Posted |
|---|---|---|
| This notice | Special Notice | |
| EzPlaz Freeze Dried Plasma FDA Approved | Pre-Solicitation |
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| Opportunity | Agency | Set-aside | Responses due |
|---|---|---|---|
| 6505--Human Blood and Blood Products | Veterans Integrated Service Network 17 | No set-aside |
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