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SAMDAILY.US - ISSUE OF JULY 02, 2024 SAM #8253
SOLICITATION NOTICE

B -- Center for Biologics Evaluation and Research (CBER), Biologics Effectiveness and Safety (BEST) Initiative #3: Data Sources for Surveillance of Biologics

Notice Date
6/30/2024 2:46:21 PM
 
Notice Type
Presolicitation
 
NAICS
518210 — Data Processing, Hosting, and Related Services
 
Contracting Office
FDA OFFICE OF ACQ GRANT SVCS Beltsville MD 20705 USA
 
ZIP Code
20705
 
Solicitation Number
75F40124R00002
 
Response Due
7/8/2024 11:00:00 AM
 
Archive Date
07/23/2024
 
Point of Contact
Nick Sartain, Phone: 8705437370
 
E-Mail Address
nick.sartain@fda.hhs.gov
(nick.sartain@fda.hhs.gov)
 
Description
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.
 
Web Link
SAM.gov Permalink
(https://sam.gov/opp/e1c29400a8d14e52a7db23b01ee9c760/view)
 
Place of Performance
Address: USA
Country: USA
 
Record
SN07112908-F 20240702/240630230058 (samdaily.us)
 
Source
SAM.gov Link to This Notice
(may not be valid after Archive Date)

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