Refrigerated storage of investigational drug

Closed Pre-Solicitation Posted

Solicitation number
75N98026Q00734
Agency
Responses due
Set-aside
Total Small Business

Opportunity facts

Place of performance
Frederick, Maryland 21703, United States
Points of contact

Notice details come from SAM.gov. Updated .

About this opportunity

The National Institutes of Health, National Human Genome Research Institute intends to award a firm-fixed-price purchase order for refrigerated storage of an investigational drug under FAR Part 6.302-1 (sole-source justification), with capability statements from small businesses—including 8(a), service-disabled veteran-owned, HUBZone, small disadvantaged, veteran-owned, and women-owned small businesses—due by 11:00 p.m. EDT on July 10, 2026.

NHGRI requires long-term refrigerated storage for 16 boxes (8x12x14" dimensions) containing 600 sachets per box of unlabeled clinical-grade investigational drug in powder-in-sachet format intended for future clinical trials in GNE-related thrombocytopenia and nephrotic disease. Storage must comply with strict temperature control and FDA-regulatory requirements. The incumbent contractor, Eminent Services Corp., has successfully stored and labeled the same drug format during the current Phase 2 clinical trial and maintains FDA-reporting documentation familiarity. Eminent can perform in-house FDA-required drug labeling using existing label design, eliminating re-shipment of unlabeled product elsewhere.

This is not a competitive solicitation. Award is anticipated approximately ten days after the July 2 notice date unless the Government determines another vendor possesses the requisite capability. Interested small businesses must submit written capability statements demonstrating ability to perform the requirement to david.shen@nih.gov.

Notice text

Attachment: Notice of Intent

Files

File Type Posted
Notice of Intent.pdf PDF

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