Purchase of Thermo Fisher reagents and supplies for immunology studies

The Food and Drug Administration's Office of Acquisition and Grant Services has issued a Special Notice for the purchase of Thermo Fisher reagents and supplies for immunology studies. This procurement is structured as an 8(a) sole source opportunity under contract number FDA-CDER-25-130466, with the FDA intending to award a Firm Fixed Price contract to Fisher Scientific Company LLC in Hanover Park, Illinois. The supplies are required by the FDA's Division of Applied Regulatory Science immunology laboratory to maintain operational readiness and conduct scientific experiments supporting regulatory research. The procurement involves 12 unique items totaling $14,981.02 plus $200 for shipping and handling, bringing the total contract value to $15,181.02. These supplies include reagents for Luminex plate reader operation, cell culture assays, and flow cytometry applications.

The FDA is utilizing FAR Part 6.302-1(a)(2)(ii) sole source authority, indicating that only one responsible source can satisfy the agency's requirements. However, the agency has issued this notice to provide other potential vendors an opportunity to demonstrate their capabilities by submitting written capability statements by September 15, 2025, at 12:00 PM EST to rodney.aytch@fda.hhs.gov. Contractors interested in participating must demonstrate they can meet the minimum requirements outlined in the Statement of Work, which includes delivering reagents with a minimum 6-month shelf life to the FDA White Oak Campus in Silver Spring, MD. The supplies support critical regulatory research initiatives including BsUFA, GDUFA, and PDUFA programs, and must be shipped only on Monday, Tuesday, or Wednesday. While the FDA anticipates awarding the contract to Fisher Scientific within five days of the notice, the agency reserves the right to pursue competitive procurement if viable alternatives are identified through submitted capability statements.