Purchase of Thermo Fisher reagents and supplies for immunology studies

This Statement of Work (SOW) outlines the requirements for the purchase of Thermo Fisher reagents and supplies for immunology studies at the FDA's Division of Applied Regulatory Science (DARS) OCP/OTS/CDER Immunology laboratory. These supplies are crucial for in vitro assays used to assess immunogenicity in large molecule drug products, supporting projects under BsUFA, GDUFA, and PDUFA research, and enabling responses to public health issues. The scope covers routine supplies for operational readiness and scientific experiments, including reagents for Luminex plate readers, cell culture, and flow cytometry. Key requirements include a minimum 6-month shelf life for reagents, dry ice shipping for refrigerated items, and specific delivery days (Monday, Tuesday, or Wednesday for AM delivery). Deliverables include a list of 12 items totaling $14,981.02, with an estimated shipping and handling cost of $200.00, due by August 15, 2025, or within two weeks of the purchase order. Deliveries must be coordinated with Kristina Howard at the FDA White Oak Campus. The period of performance is July 31, 2025, to August 31, 2025. Inspection and acceptance criteria include proper packaging, undamaged receipt, and verification by the Project Officer against the packing slip.

The Food and Drug Administration (FDA) issued a Notice of Intent to Sole Source on September 10, 2025, for the purchase of Thermo Fisher reagents and supplies for immunology studies (FDA-CDER-25-130466). The FDA intends to award a Firm Fixed Price contract to Fisher Scientific Company LLC, citing FAR Part 6.302-1 (a)(2)(ii) which allows for sole-source awards when only one responsible source can satisfy agency requirements. This notice is not a request for competitive proposals; however, any party believing it can meet the stated requirements may submit a written capability statement by September 15, 2025, at 12:00 PM EST to rodney.aytch@fda.hhs.gov. The government will review submissions and, at its discretion, may choose to compete the proposed contract. Otherwise, an award is anticipated for Fisher Scientific Company, LLC within approximately five days of the notice date.