Note of Intent to Award Sole Source
Type: Special Notice
Overview

Buyer

DEPT OF DEFENSEDEFENSE HEALTH AGENCY (DHA)ARMY MED RES ACQ ACTIVITYFORT DETRICK, MD, 21702, USA

NAICS

Research and Development in Biotechnology (except Nanobiotechnology) (541714)

PSC

MEDICAL- PHARMACOLOGY (Q517)

Original Source

https://sam.gov/opp/6fb7cf4e6c8541c5a04f72e0f89d7286/view
Timeline
    Description

    The Department of Defense, through the United States Army Medical Research Acquisitions Activity (USAMRAA), intends to modify an existing contract related to the CryoPreserved Platelets (CPP) project. This modification aims to increase the cost ceiling to accommodate the need for additional subjects in clinical trials, which is critical for advancing to Phase 3 and obtaining FDA licensure for CPP. The contract modification will cover various activities, including the recruitment of up to 400 more subjects, increased consultant and travel expenses, material costs, regulatory expenses, and site activations, with no other FDA-licensed manufacturers for CPP identified in the U.S. Interested suppliers are encouraged to respond in writing within 15 days of this notice, and inquiries can be directed to Peter Mitchell at peter.d.mitchell8.civ@health.mil.

    Point(s) of Contact
    Timothy Kelly
    (301) 619-7806
    timothy.j.kelly169.civ@health.mil
    Files
    Title
    Posted
    CPP-Notice of Intent to Sole Source.docx
    The United States Army Medical Research Acquisitions Activity (USAMRAA) announces an intent to modify an existing contract for the CryoPreserved Platelets (CPP) project, increasing the cost ceiling due to the need for more subjects in clinical trials. The modification is based on the performance of the contract research organization (CRO) working on the Phase 2 trial, which is essential for advancing to Phase 3 and seeking FDA licensure for CPP. The contract modification will encompass various additional activities costing up to 400 more subjects, increased consultant and travel expenses, material costs, regulatory expenses, and site activations. Market research reveals no other FDA-licensed companies within the U.S. to manufacture CPP, reinforcing the need for this sole-source modification. Eligible suppliers are invited to respond in writing within 15 days of the notice. The NAICS code for this requirement is 541715, with a size standard of 1,250 employees. Questions can be directed to Peter Mitchell at a specified email address prior to the response deadline.
    ETEC Notice of Intent to Sole Source.docx
    The United States Army Medical Research Acquisitions Activity (USAMRAA) intends to modify an existing contract with Scandinavian Biopharma for the development of a Phase 2 Clinical cGMP manufactured vaccine against Enterotoxigenic Escherichia coli (ETEC). This notice does not request proposals but aims to address a significant gap in infectious disease prevention for Warfighters, as no effective ETEC vaccine is currently available. Scandinavian Biopharma's Etvax vaccine, suitable for adult travelers, has shown safety and efficacy in trials, with the second generation offering improved strain coverage and stability. The contract modification will occur on a sole source basis, identified by NAICS code 325412, and the government's commitment to a competitive procurement process is noted. Interested parties have a fifteen-day window to respond with proof of capability before the contract is awarded. This notice underscores the government's effort to enhance vaccine options and promote public health for military personnel.
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    Note of Intent to Award Sole Source
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