Notice of Intent to Sole Source-Freeze Dried Plasma (W81xwh-20-C-0088 Modification) Tender

Procurement Summary

Country : USA

Summary : Notice of Intent to Sole Source-Freeze Dried Plasma (W81xwh-20-C-0088 Modification)

Deadline : 07 Jun 2024

Other Information

Notice Type : Tender

TOT Ref.No.: 101645606

Document Ref. No. :

Competition : ICB

Financier : Self Financed

Purchaser Ownership : Public

Tender Value : Refer Document

Purchaser's Detail

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Tender Details

Description

Notice of Intent to Sole Source

The United States Army Medical Research Acquisition Activity (USAMRAA) on behalf of the United States Army Medical Materiel Development Activity (USAMMDA), Warfighter Protection and Acute Care Project Management Office (WPAC PMO), intends to execute a modification (W81xWH-20-C-0088) on a sole source basis under the authority of FAR 6.302-1(a)(2), only one responsible source and no other supplies or services will satisfy agency requirements, to Vascular Solutions LLC, 6464 Sycamore Court N, Maple Grove, Minnesota, 55369. This requirement will 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.”

Vascular Solutions LLC is the only source able to meet the Government requirements. The purpose of this contract is to continue conducting several activities necessary to successfully obtain and sustain commercial viability of an FDA licensed FDP product. This modification will increase the level of effort and extend the contract period of performance end date from 14 September 2024 to 14 September 2025 (12 months). 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 Biologic License Application (BLA) re-submission. Vascular Solutions LLC is the regulatory sponsor of the BLA and will manufacture, market, and distribute the FDP product. There are n...
Active Contract Opportunity Notice ID Related Notice W81xWH-20-C-0088-P00010 Department/Ind. Agency DEPT OF DEFENSE Sub-tier DEFENSE HEALTH AGENCY (DHA) Office ARMY MED RES ACQ ACTIVITY
General Information
Contract Opportunity Type: Special Notice (Original)
All Dates/Times are: (UTC-04:00) EASTERN STANDARD TIME, NEW YORK, USA
Original Published Date: May 23, 2024 10:02 am EDT
Original Response Date: Jun 07, 2024 02:00 pm EDT
Inactive Policy: 15 days after response date
Original Inactive Date: Jun 22, 2024
Initiative: None

Classification
Original Set Aside:
Product Service Code:
NAICS Code: 541715 - Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)

Place of Performance: Frederick, MD 21702 USA

Documents

 Tender Notice

B01-W81XWH-20-C-0088-P00010-NOI-Sole-Source-20240523-Posted.docx