Collaborating Centers of Excellence in Regulatory Science and Innovation (U01)

Food and Drug Administration

Description

FDA is announcing this FOA to provide support for one or more Collaborating Centers of Excellence in Regulatory Science and Innovation (CERSI). Regulatory Science is defined as the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of FDA-regulated products. The CERSI’s will be established to foster an innovative and thematically coherent approach to advance the field of Regulatory Science (e.g., Regulatory Science encompasses laboratory, population, behavioral and manufacturing sciences, as well as other scientific programmatic areas, including those outlined in FDA's Strategic Plan for Regulatory Science, accessible at http://www.fda.gov/ScienceResearch/SpecialTopics/RegulatoryScience/ucm267719.htm) and the Critical Path Initiative toward more effective and efficient product development and evaluation. CERSI efforts will focus on promoting innovation in support of the development and evaluation of safe and effective products through training, applied collaborative science, professional development and scientific exchanges. The CERSI's should be internationally recognized for the outstanding expertise in the respective field(s). CERSI's candidates may apply either as single institutions or as consortia of more than one institution and are encouraged to include plans and business models which describe how the entity would continue its role and function as FDA-partnering scientific expert center beyond the funding provide with this CERSI mechanism.

Who can apply

• Public and State controlled institutions of higher education
• Private institutions of higher education

Contact

Vieda Hubbard <br/>Grants Management Specialist <br/>Phone 301-827-7177
vieda.hubbard@fda.hhs.gov