Notice of Intent to Sole Source – BD BIOSCIENCES

The National Institutes of Health (NIH) is seeking a sole-source 5-year service contract with BD Biosciences for the maintenance of BD FACSLyric flow cytometers and BD Lyse/Wash Assistants. This justification for "Other than Full and Open Competition" is based on FAR 13.106-1(b)(1), citing that BD is the only source reasonably available due to their proprietary technology and the critical need for specialized maintenance and support. The instruments are essential for processing patient samples, identifying cell populations for clinical research, and ensuring compliance with FDA 21 CFR 211.67. The estimated cost for the 5-year contract is $318,511.20. The NIH emphasizes that failure to secure this service could result in harm to NIH Clinical Center patients, many of whom are involved in research due to unique conditions. Market research will be conducted as deemed necessary, and efforts to overcome barriers to competition for future acquisitions will be considered, though currently, no other vendor can provide the required high-quality service and materials that meet FDA requirements.

This Statement of Work outlines the requirements for preventive maintenance, support, and emergency servicing of BD FACSLyric flow cytometers and BD Lyse/Wash Assistants (LWAs) for the Center for Cellular Engineering (CCE) at NIH. These instruments are crucial for manufacturing and characterizing cellular therapy products used in over 50 intramural clinical trials, supporting treatments for various diseases. The contractor will provide annual preventive maintenance, a PM kit, software revisions, unlimited service visits, 24-hour emergency response, and unlimited telephone support. The contract spans a base year from April 2026 to March 2027, with four option years, extending through March 2031.

The National Institutes of Health (NIH), Clinical Center, issued a Notice of Intent (NOI-OD-26-003977) to award a sole source, five-year service contract to BD BIOSCIENCES. This contract is for the preventive maintenance of two sets of BD FACSLyric flow cytometers with Universal Loaders and two sets of BD Lyse/Wash Assistants. These instruments are crucial for processing patient samples, identifying cell populations for clinical research and therapeutic product development, assessing gene modification efficiencies, and quality controlling cell selection methods. BD Biosciences is identified as the sole vendor capable of providing the required maintenance. The acquisition is being conducted under Federal Acquisition Regulation (FAR) Part 13 – Simplified Acquisition Procedures, specifically Subpart 13.106-1(b)(1), which allows for soliciting from a single source when only one is reasonably available for purchases not exceeding the simplified acquisition threshold. Interested parties may submit comments by March 25, 2026, to Ryssa Nix at Ryssa.nix@nih.gov.