NeuroNEXT Clinical Trials (U01)

Funding Opportunity Announcement (FOA) Number	PAR-13-343
Companion Funding Opportunity	PAR-11-344, X01 Resource Access Award PAR-11-345, U44 Small Business Innovation Research (SBIR) Cooperative Agreement
Number of Applications	See Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.853
Funding Opportunity Purpose	This FOA encourages applications for exploratory clinical trials of investigational agents (drugs, biologics, surgical therapies or devices) that may contribute to the justification for and provide the data required for designing a future trial, for biomarker validation studies, or for proof of mechanism clinical studies.  Diseases chosen for study should be based on the NINDS' strategic plan and clinical research interests (www.ninds.nih.gov/funding/areas/index.htm).  Successful applicants will be given access to the NeuroNEXT infrastructure. Following peer review, NINDS will prioritize and order trials that are given access to the NeuroNEXT infrastructure.  The NeuroNEXT Clinical Coordinating Center (CCC) will work with the successful applicant to efficiently implement the proposed study.  The NeuroNEXT Data Coordinating Center (DCC) will provide statistical and data management support.  The NeuroNEXT clinical sites will provide recruitment/retention support as well as on-site implementation of the clinical protocol. Applicants do not need to be part of the existing NeuroNEXT infrastructure.

Key Dates

Posted Date	August 30, 2013
Open Date (Earliest Submission Date)	November 2, 2013
Letter of Intent Due Date(s)	Not Applicable
Application Due Date(s)	December 2, 2013; April 2, 2014; August 1, 2014; December 2, 2014; April 3, 2015; August 3, 2015; December 3, 2015, by 5:00 PM local time of applicant organization. Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.