The Duke Funding Alert newsletter, published every Monday, provides information on all new and updated grants and fellowships added to the database during the prior week. This listserv is restricted to members of the Duke community.
NINDS CREATE Devices: Translational and Early Feasibility Studies on the Path to Pre-Market Approval (PMA) or Humanitarian Device Exemption (HDE) (UH2/UH3)
The purpose of this Funding Opportunity Announcement (FOA) is to encourage applications to pursue translational and Early Feasibility Studies for therapeutic devices to treat neurological disorders. The program will utilize a cooperative agreement mechanism to support the submission of an Investigational Device Exemption (IDE), with the option of also supporting the following Early Feasibility Study. It is expected the immediate next steps upon completion of the Early Feasibility Study will be a full Feasibility Study and a Pivotal Trial in support of a PMA (Pre-Market Approval) or HDE (Humanitarian Device Exemption). Activities supported in this program include implementation of clinical prototype devices, preclinical safety and efficacy testing, design verification and validation activities, pursuit of regulatory approval for the clinical study, and an Early Feasibility Study.
PAR-14-296, U44 Small Business Innovation Research (SBIR) Cooperative Agreement – Fast-Track
PAR-14-299, U44 Small Business Innovation Research (SBIR) Cooperative Agreement – Fast-Track
PAR-14-300, U44 Small Business Innovation Research (SBIR) Cooperative Agreement – Fast-Track
PAR-14-297, UH2/UH3 Phase Innovation Awards Cooperative Agreement
- Application Due Date(s): October 21, 2014; February 11, 2015, August 11, 2015, February 11, 2016, August 11, 2016, February 8, 2017, by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on these dates.
- AIDS Application Due Date(s): January 7, 2015; May 7, 2015; September 7, 2015; May 7, 2016; September 7, 2016; and May 7, 2017, by 5:00 PM local time of applicant organization.
PAR-14-298 Expiration Date May 8, 2017