Refrigerated storage of investigational drug

Background
The National Institutes of Health (NIH), specifically the National Human Genome Research Institute (NHGRI), intends to award a Firm-Fixed-Price Purchase Order to Eminent Services Corp. for the long-term refrigerated storage of a large batch of unlabeled investigational drug. This drug is intended for use in future clinical trials for conditions such as GNE-related thrombocytopenia or nephrotic disease, and must be stored under strict temperature control and FDA regulatory requirements.

Work Details
The contractor will be responsible for the long-term refrigerated storage of a large batch of investigational drug packaged as powder-in-sachets, stored in 16 boxes with dimensions of 8x12x14 inches, containing 600 sachets per box. The storage must adhere to strict temperature control and comply with FDA regulatory requirements.

Eminent Services Corp. has previously stored and labeled similar drug-in-sachet products for ongoing Phase 2 clinical trials, demonstrating familiarity with the drug and its FDA-reporting documentation. They are also capable of performing the required FDA drug labeling in-house, eliminating the need for re-shipping unlabeled drugs for this process. The same label design used for the current clinical trial can be adapted for this new batch.

Period of Performance
The anticipated award will be issued approximately ten days after the date of this notice.

Place of Performance
Frederick MD 21703 UNITED STATES

Bidder Requirements
This opportunity is a Small Business Set Aside - Total (SBA). Any available small businesses, including those that are 8(a), service-disabled veteran owned, HUBZone, small disadvantaged, veteran-owned, or women-owned, may submit a written capability statement demonstrating their ability to perform the requirement.

Incumbent Analysis (see Incumbents section for more detail)
This opportunity appears to have a confirmed incumbent based on prior contract 75N92025P00350 awarded to Eminent Services for refrigerated transport and storage of investigational drug (09/03/25–08/31/26, $29,276). The current requirement similarly calls for long-term refrigerated storage of an investigational drug under strict temperature control and FDA regulatory requirements, suggesting the prior work is a continuation or follow-on effort supporting ongoing or subsequent clinical trial drug handling.