SAFE-PLASMA Protocol
Open Pre-Solicitation Posted
- Solicitation number
- HT9427-27-SSN-701
- Agency
- Not on record
- Responses due
- Set-aside
- No set-aside
Opportunity facts
- NAICS code
- 541715 Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)
- PSC
- Not on record
- Place of performance
- Maryland 21702, United States
- Points of contact
Notice details come from SAM.gov. Updated .
About this opportunity
The Defense Health Agency Contracting Activity, on behalf of the Portfolio Acquisition Executive for Medical Products' Warfighter Protection and Acute Care Project Management Office, intends to issue a sole-source contract modification to Westat Inc. of Rockville, Maryland, with capability statements due November 16, 2026. The notice uses no set-aside. The modification would have Westat modify the current clinical trial design to comply with FDA recommendations and conduct a Good Clinical Practices (GCP) compliant clinical trial meeting U.S. Food and Drug Administration requirements for EZPLAZ approval. The attached Sources Sought Notice, filed under NAICS 541715 (Research and Development in the Physical, Engineering, and Life Sciences), states that it is issued for market research only and does not constitute a solicitation or obligation. It also states that Westat conducted the Phase 1 trial used for EZPLAZ licensure and developed the protocol and Statistical Analysis Plan for the current safety evaluation. The government will use capability statements to choose between a competitive procurement and the sole-source modification under 10 U.S.C. 3204(a)(1), and it reserves the right not to compete. Statements may not exceed five pages (8.5 x 11 inches, 10-point minimum font) and must include management and technical data with a rough order of magnitude. Submissions are due by 2:00 PM local time on November 16, 2026, by email only, as Microsoft Word or Adobe PDF attachments, to jamie.l.diggs.civ@health.mil.
Notice text
The Defense Health Agency Contracting Activity, on behalf of Portfolio Acquisition Executive for Medical Products, Warfighter Protection and Acute Care Project Management Office, intends to issue a contract modification on a sole-source basis with Westat Inc. 1600 Research Blvd. Rockville, MD 20850. This modification will enable Westat Inc. to modify the current clinical trial design to comply with FDA recommendations and to conduct the Good Clinical Practices (GCP) compliant clinical trial in accordance with U.S. Food and Drug Administration’s requirements for EZPLAZ™ approval.
Files
| File | Type | Posted |
|---|---|---|
| B01-Sources Sought Notice.docx | DOCX document |
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