Center for Biologics Evaluation and Research (CBER), Biologics Effectiveness and Safety (BEST) Initiative #3: Data Sources for Surveillance of Biologics
Closed Pre-Solicitation Posted
This opportunity was awarded. See its 4 award notices in the notice history.
- Solicitation number
- 75F40124R00002
- Agency
-
FDA Office of Acquisition and Grant Services
Food and Drug Administration, Department of Health and Human Services
- Responses due
- Set-aside
- No set-aside
Opportunity facts
- NAICS code
- 518210 Computing Infrastructure Providers, Data Processing, Web Hosting, and Related Services
- Place of performance
- United States
- Points of contact
Notice details come from SAM.gov. Updated .
About this opportunity
The Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER) is seeking new data sources, including administrative claims data or claims and electronic health record (EHR) data, to support the Biologics Effectiveness and Safety (BEST) Initiative #3: Data Sources for Surveillance of Biologics. The primary objective is to obtain large-scale, longitudinal healthcare data from the United States covering tens of millions of patients, as well as access to full medical charts for patient data review and adjudication. The successful contractor must be a provider and primary source of the data, such as a health insurer, payer, or provider. The evaluation will be an unrestricted, full and open competition, with the associated NAICS code being 518210 - Computing Infrastructure Providers, Data Processing, Web Hosting, and Related Services. The FDA anticipates a multiple-award Indefinite Delivery/Indefinite Quantity contract with a 5-year ordering period.
This opportunity is not set-aside for any specific business size or type. The FDA has not identified any potential incumbents or current contractors. The anticipated performance period is 5 years, but the FDA has not provided any budget ranges or award value details. Vendors are encouraged to sign up on the Interested Vendors List to receive automated notifications of any changes to the posting.
Notice text
The Food and Drug Administration, Center for Biologics Evaluation and Research (CBER) requirement for Biologics Effectiveness and Safety (BEST) Initiative #3: Data Sources for Surveillance of Biologics (BEST 3).
The primary goal of this Contract is to obtain new data sources including administrative claims data or claims and EHR data with access to complete medical chart information, provided directly from primary sources such as an insurer, payer or provider. Contractor must provide FDA with: distributed-type access to large-scale, United States (US) health care data covering tens of millions of patients; adjudicated administrative claims data but data sources may also include EHR using a distributed data network which may use a common data model (CDM) (potentially OMOP CDM) (data sources shall provide longitudinal health care data for participating patients); access to full medical charts of patients whose health care data are available for review, abstraction, and adjudication in the context of biologic products surveillance activities; contractor must be a provider and primary source of the data such as health insurer, payer or provider.
This requirement will be unrestricted, full and open competition.
The associated North American Industry Classification System (NAICS) Code is 518210- Computing Infrastructure Providers, Data Processing, Web Hosting, and Related Services; Small Business Size Standard is $40 million.
The FDA anticipates a multiple award Indefinite Delivery/Indefinite Quantity contract with an anticipated performance period of a 5-year ordering period.
Vendors are encouraged to sign up on the Interested Vendors List to receive automated notification from SAM.gov when changes are made to the posting; however, contractors are responsible to monitor this website for further information concerning this procurement.
Notice history
5 of 6 notices listed here. See the rest on GovTribe.
On GovTribe
Work this opportunity
- Track it in your pipeline
- Find teaming partners
- Similar opportunities
- Ask GovTribe AI about this opportunity