FDA Sources Sought: Data Sources for Surveillance of Biologics (BEST 3)

Notice ID: FDA-SSN-CBER-2023-116031

Description

The U.S. Food and Drug Administration (FDA) is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biologic products, medical devices, tobacco products, our nation’s food and blood supply, cosmetics and products that emit radiation…

The primary objective of this solicitation is to obtain and maintain data sources for the CBER BEST Initiative. This solicitation seeks large-scale adjudicated administrative claims data sources covering health records of tens of millions of individuals living in the US with full access to their medical records, as well as large-scale electronic health records (EHR) which provide access to both structured and unstructured data elements of EHR and full medical records of individuals, and linked claims-EHR data sources covering large populations and providing access to full medical records. The data sources should also have the capability to link their data to the immunization registries across the country called Immunization Information System (IIS) to supplement their vaccine exposure data with respect to all vaccines particularly COVID-19, seasonal influenza, monkeypox, and others…

The Contractor shall, independently and not as an agent of the Government, provide all necessary resources and personnel to support the CBER BEST program for the post-market safety and effectiveness surveillance of all biologic products. The scope of this program is the following. The data sources shall provide:

1. Health care data covering exposure to all US biologic products particularly vaccines, blood products, tissues and advanced therapeutics.
2. Processes to provide access to full medical charts of all patients stripped of any individual identifiers for review, abstraction, and adjudication in the context of surveillance activities.
3. Support for the CDM (if utilized) to accommodate granular clinical data and some ancillary clinical data such as laboratory test results and others (if available).
4. The data will be refreshed on a monthly (or every two weeks) basis for administrative claims data sources and more frequently for EHR data sources. The data lag shall not be longer than three months.
5. The available data for analyses are quality checked using a rigorous and structured approach…

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Tags: FDA HHS SAM.gov