Justification-Center for Biologics Evaluation and Research (CBER) Scientific Data Abstraction and Information Management

The contract is a sole-source firm-fixed-price purchase order issued by the Food and Drug Administration’s Office of Acquisition and Grant Services on behalf of the Center for Biologics Evaluation and Research (CBER) to support scientific data abstraction and information management services. The acquisition was justified under FAR 6.302-1, which permits non-competitive awards when only one responsible source exists and no other supplies or services can satisfy agency requirements. The contractor, identified as MPF-ZAI, possesses exclusive access to proprietary database systems and employs specialized, validated methodologies for data abstraction that are not replicable by other vendors, making competition impossible. The total estimated value of the contract is $2,001,241.20, with performance located in Silver Spring, Maryland, and oversight administered from Rockville, Maryland. The work is critical to CBER’s mission of ensuring the safety, purity, and efficacy of biologics such as vaccines, blood products, and gene therapies through the transformation of raw scientific data into decision-ready regulatory information. No competitive evaluation process was conducted, and no formal evaluation factors, weights, or ratings were applied. The procurement does not include any option periods, detailed line-item pricing, or breakdowns for base versus option years. The statement of work is implied but not fully detailed in the provided documentation, and no formal contract clauses from FAR Part 52 are listed. There are no specified packaging, marking, preservation, or barcoding requirements, and no shipping terms such as FOB are defined. Payment and accounting details including TAS, AAC, or ACRN codes are not provided, nor are invoicing protocols or remittance instructions specified. The Contracting Officer’s Representative is Sherrie High, and primary points of contact are Natalie Brown and Ian Weiss, but the Procuring Contracting Officer’s identity is not disclosed. No representations, certifications, or socioeconomic status information from the contractor are included, and no unique entity ID, CAGE code, or size certification is stated. The contractor’s qualifications are based solely on unique technical capability, with no requirement for competitive bidding, and future competitions are noted as a planned objective, though not yet implemented.