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

The summary for the Collaborating Centers of Excellence in Regulatory Science and Innovation (U01) grant is detailed below. This summary states who is eligible for the grant, how much grant money will be awarded, current and past deadlines, Catalog of Federal Domestic Assistance (CFDA) numbers, and a sampling of similar government grants. Verify the accuracy of the data FederalGrants.com provides by visiting the webpage noted in the Link to Full Announcement section or by contacting the appropriate person listed as the Grant Announcement Contact. If any section is incomplete, please visit the website for the Food and Drug Administration, which is the U.S. government agency offering this grant.

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