Whole Blood and Apheresis Platelets

The Food and Drug Administration's Center for Biologics Evaluation and Research, Office of Blood Research and Review, is seeking a contractor to provide whole blood and apheresis platelet research specimens for their Pathogen Reduction Technology Program. The solicitation requires 45 units each of whole blood (400-450 mL collected in citrate-phosphate-dextrose solution) and apheresis platelets (200-400 mL stored in 100% plasma or with 65% platelet additive solution) to be collected from consenting volunteer research donors through an IRB-approved program. The contractor must collect specimens on a weekly schedule and ensure they are ready for FDA courier pickup within 4-8 hours of collection, with the contractor being responsible for collection, storage, and preparation of all specimens. This is a firm-fixed price commercial item acquisition using simplified acquisition procedures under full and open competition. The original due date of August 8, 2025, has been extended to August 13, 2025, by 1:00 PM Central Time through Amendment 1.

No set-aside designation has been applied to this solicitation, making it available for full and open competition with a small business size standard of $40.0 million. The solicitation does not identify any current incumbents or potential contractors, nor does it specify the contract's total value or budget range. The performance period is established at 47 weeks, requiring weekly collection and delivery of the specified blood specimens throughout this duration. The contractor must be strategically located within a 45-minute commute of FDA headquarters to ensure timely specimen delivery. All work will be performed in the Silver Spring, Maryland area, specifically at 20993, with the contractor's proximity to the FDA facility being critical for the success of the research program's logistics and specimen integrity requirements.