Intent to Sole Source BD Bioscience Reagents for In Vitro Diagnostics

: To purchase all reagents and consumables on an as-needed basis for clinical patient-care quality control flow cytometry assays by using FACSLyris flow cytometer instrument from BD Bioscience. Each time the instrument is used, fresh vials of monoclonal antibodies, assay quality controls, buffers, fluids, and disposable components must be used. This contract is to purchase the monoclonal antibodies, assay quality controls, buffer, sheath fluids, and disposable components. The monoclonal antibodies are sold as sterile single use vials. For each procedure one to four vials are used. The Center of Cellular Engineering, Department of Transfusion Medicine is an AABB-accredited cellular therapy laboratory whose central mission is to provide services to support NIH's intramural clinical trials. CCE produces clinical therapies from cells collected from NIH Clinical Center (CC) patients and healthy donors. The products are manufactured by the laboratory are used to treat patients with cancer, hematological malignancies, marrow failure, congenital immune disorders, and autoimmune diseases. Products are manufactured using US Food and Drug Administration (FDA) guidelines for manufacturing practices. BD Biosciences is a leading provider of flow cytometry instruments, reagents, and assay solutions used in clinical quality control (QC) and patient-care testing. BD Biosciences offers a comprehensive portfolio of validated antibodies, controls, and reagents that support immunophenotyping, in-process testing, and lot release flow cytometry assays performed under regulated clinical laboratory environments. The statutory authority for this sole source requirement is 41 U.S.C. 1901 (a) (1) as implemented by FAR 13.106-1 only one responsible source and no other supply of service will satisfy agency

requirements. THIS IS NOT A REQUEST FOR PROPOSAL. All responsible sources that could provide the required may submit a capability statement that will be considered by email (subject line to reference NOI-CC-26-002633) by 11:00 AM eastern standard time on 03/11/2026 to: [email protected] All responses received by the closing date of this synopsis will be considered by the Government. A determination not to compete this requirement, based upon responses to this notice, is solely within the discretion of the Government. Contracting (No Street Address

2) Bethesda, MD 20892 US to this opportunity. Estimated Cost of BD Antibodies and reagents for 5-year plan _Final_01_20-2025 (1).xlsx SOW - BD 2026.docx