The NIH Clinical Center’s Department of Transfusion Medicine/Center for Cellular Engineering intends to award a sole-source contract to Miltenyi Biotec, Inc. for preventive maintenance and service support of seven Miltenyi Biotec CliniMACS Plus instruments used in FDA-regulated cGMP manufacturing of patient-specific cellular therapies at the NIH Clinical Center. The required services include preventative maintenance, calibration, inspections, software updates, diagnostic testing, troubleshooting, repair support, replacement of proprietary service parts, and technical support for specified instruments. NIH states that Miltenyi is the original equipment manufacturer and only known authorized provider with the proprietary software, diagnostic tools, parts, and technical requirements needed to maintain validated manufacturing processes and regulatory compliance. Responsible sources may submit capability statements demonstrating manufacturer authorization, access to proprietary software and parts, and ability to maintain validated operating conditions and provide maintenance reports to CCE Quality Assurance.