Notice of Intent to Sole Source for Single Donor Tender - 142673064

Procurement Summary

Country: USA

Summary: Notice of Intent to Sole Source for Single Donor, Type Specific, Universal Freezedried Plasma Activities for Commercial Sustainability

Deadline: 22 Jun 2026

Posting Date: 05 Jun 2026

Other Information

Notice Type: Tender

TOT Ref.No.: 142673064

Document Ref. No.: HT942726RE014

Competition: ICB

Financier: Self Financed

Purchaser Ownership: Public

Tender Value: Refer Document

Purchaser's Detail

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Tender Details

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 wo...
Notice ID: ht942726re014

Department/Ind. Agency: dept of defense

Sub-tier: defense health agency (dha)

Office: defense health agency

Product Service Code: an13 - health r&d services; health care services; experimental development

NAICS Code: 541715 - Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)

Inactive Dates: jul 07, 2026

Inactive Policy: 15 days after response date

Documents

 Tender Notice