Bill > HR5414

This bill, known as the FDA Cross-Center Collaboration Act of 2016, aims to improve how the Food and Drug Administration (FDA) handles major disease areas by establishing one or more "Intercenter Institutes." These institutes would be created within the FDA to foster better coordination between different FDA centers, specifically the Center for Drug Evaluation and Research (CDER), the Center for Biologics Evaluation and Research (CBER), and the Center for Devices and Radiological Health (CDRH). The goal is to streamline processes for reviewing medical products, promote scientific programs, enhance training for staff with relevant expertise, improve interactions with patients and industry, and facilitate collaboration with other government health agencies, all focused on specific major disease areas. Before establishing an institute, the Secretary of Health and Human Services must allow for public comment, and at least one institute must be established within one year of the bill's enactment. The Secretary can also terminate an institute if it's no longer beneficial to public health, provided there's at least 60 days' public notice and a stated reason.