The CBER Biologics Effectiveness and Safety (BEST) Initiative #3: Data Sources for Surveillance of Biologics (BEST 3)
Closed Pre-Solicitation Posted
This opportunity was awarded. See the award notice from , or the latest solicitation from .
- Solicitation number
- FDA-SOL-1224068
- 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
Notice details come from SAM.gov. Updated .
About this opportunity
This notice seeks data sources for the FDA's Center for Biologics Evaluation and Research's Biologics Effectiveness and Safety Initiative #3. Specifically, the FDA seeks new data sources containing administrative claims data or claims and EHR data covering tens of millions of US patients from primary sources such as insurers or providers. Data sources must provide longitudinal healthcare data through a distributed data network potentially using the OMOP common data model, and full medical charts must be accessible for review. Awards will be made through multiple IDIQ contracts with a five-year ordering period to contractors who can directly provide large-scale US healthcare data as the primary source. Questions are due by July 23, 2020.
There is no set-aside designated for this procurement. It is classified under NAICS 518210 with a small business size standard of $35 million. No potential incumbents or current contractors were named. As an IDIQ contract, specific award values are unknown but the anticipated period of performance is five years.
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: Data Processing, Hosting, and Related Services; the Small Business Size Standard is $35 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 FBO when changes are made to the posting; however, contractors are responsible to monitor this website for further information concerning this procurement.
Interested Parties with comments, questions, etc., shall respond to Suzanne Martella at suzanne.martella@fda.hhs.gov
Notice history
| Notice | Type | Posted |
|---|---|---|
| The CBER Biologics Effectiveness and Safety (BEST) Initiative #3: Data Sources for Surveillance of Biologics (BEST 3) | Award Notice | |
| The CBER Biologics Effectiveness and Safety (BEST) Initiative #3: Data Sources for Surveillance of Biologics (BEST 3) | Solicitation | |
| This notice | Pre-Solicitation |
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