CBER Biologics Effectiveness and Safety (BEST): Initiative Community Engagement and Development Initiative

The Food and Drug Administration, Center for Biologics Evaluation and Research (CBER) requirement for Biologics Effectiveness and Safety (BEST) Initiative - Community Engagement and Development Initiative

The U.S. Food and Drug Administration (FDA), Center for Biologics Evaluation and Research (CBER) has a requirement for a convener organization to provide the FDA with support to collaborate with FDA staff to convene meetings or workshops; coordinate or conduct methods development activities; conduct training and outreach to educate FDA staff and external stakeholders on the CBER BEST system. This work promotes OBE’s mission to assure the safety and effectiveness of biologic products including vaccines, blood and blood products, tissues and advanced therapeutics.  This work complements and supports other previous and current Biologics Effectiveness and Safety (BEST) sponsored activities to evaluate product safety and effectiveness and the use of innovative methods to potentially automate adverse event reporting for some biologic product areas.

This requirement will be unrestricted, full and open competition.

The associated North American Industry Classification System (NAICS) Code is 611710 - Educational Support Services; Small Business Size Standard is $16.5 million.

The FDA anticipates a single 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 Howard Nesmith at howard.nesmith@fda.hhs.gov