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

Background
The Center for Biologics Evaluation and Research (CBER) is part of the FDA and is responsible for ensuring the safety and efficacy of biologics. This contract aims to support CBER's public health mission through effective records management, information governance, and scientific data abstraction.

Work Details
The contractor will provide scientific data abstraction and information management services. This includes life cycle records management, information management, bioinformatics support, regulatory data quality assurance, document management functions, and business operations support for CBER. The services are critical to maintaining the purity, potency, safety, and efficacy of biologics. The contract is a follow-on to previous orders (75F40120D00022/75F40121F19014) and is categorized as support services (non-R&D).

Place of Performance
The geographic location for performance is not explicitly stated in the provided information.

Incumbent Analysis (see Incumbents section for more detail)
This opportunity appears to have a confirmed incumbent based on prior CBER scientific data abstraction and information management work performed by Mpf-Zai Solutions under contract 75F40120D00022-75F40121F19014 (value $1,824,817, 05/12/21–05/31/25). The current requirement for scientific data abstraction and information management (including life cycle records management, document management, and regulatory data quality assurance) aligns closely with the prior award’s CBER scientific data abstraction and information management scope, suggesting continuity of the same operational support functions.