December 5, 2019
FOOD AND DRUG ADMINISTRATION (FDA)
The U.S. Food and Drug Administration, Center for Biologics Evaluation and Research (CBER) and Center for Drug Evaluation and Research (CDER), intends to support research activities that enable progress in drug development tool (DDT) qualification through a Funding Opportunity Announcement (FOA) in early 2020. With this FY2020 Request For Applications (RFA), issuance of new cooperative agreements are anticipated under Limited Competition to support research to continue the development of drug development tools that have an accepted Letter of Intent (LOI) within a drug development tool qualification program within either CBER or CDER (Animal Models, Biomarkers, and Clinical Outcome Assessments) and starting FY2020, CBER DDT applicants are also expected to be eligible for these grants. The LOI needs to be fully ACCEPTED (the determination letter of LOI acceptance to the project has been issued by FDA) and the project is in the active status with FDA, working toward a goal of FDA qualification by the closing date of the RFA. The grants will be used to further the development of tools that, once qualified, will be made publicly available to fill unmet needs in drug development. Funds Available and Anticipated Number of Awards will be determined later, contingent upon the Agency budget approval and the program priority.
The FY2020 announcement is expected to be similar to the FY2019 FOA RFA-FD-19-028. You may refer to the expired RFA for Drug Development Tools Research Grants at RFA-FD-19-028.
The FOA is expected to be published in early 2020 with an expected application due date sixty days (60) after publication.
APPLICATIONS ARE NOT BEING SOLICITED AT THIS TIME.
To the appropriate DDT qualification program for your DDT project.
Grants Management Specialist
Office of Operations, Office of Finance Budget & Acquisitions
Office of Acquisitions and Grants Services, HFA-500
U.S. Food and Drug Administration