Translational Neural Devices (R61/R33 - Clinical Trial Optional)

Funding Agency:

  • National Institutes of Health
RFP# and Website: 
PAR-24-151
Description: 

A. Overview

This NOFO supports non-clinical testing to enable IRB approval needed to conduct a small NSR clinical study. Studies addressing neurological diseases and care across the lifespan are highly encouraged. All projects must have two phases: R61 and R33. The R61 phase will support non-clinical testing to obtain IRB approval for an NSR clinical study. All projects will start at the R61 phase. The duration of the R61 phase will depend on the maturity of the project at entry and can range from one to two years. Only those R61 phase projects that have met specific criteria (see below) will transition to the R33 phase after NIH administrative review. The R33 phase will support a small clinical study and can last one to three years, however, the total project period (including both the R61 and R33 phases) must not exceed five years. Projects for which only a clinical phase is proposed are outside of the scope of this funding opportunity.

This NOFO utilizes a R61/R33 Exploratory/Developmental Phased Award mechanism. As such, this NOFO supports milestone-driven projects and involves NIH program staff’s participation in negotiating project and milestone plan before award, monitoring the research progress, and making go/no-go decisions. The expectations of the program are in line with those of industry regarding the advancement of devices through the developmental and translational pipelines. As such, an inherent rate of attrition is possible within this program.

Applicants are strongly advised to contact the Scientific/Research contact listed below prior to submission.

B. Scope

Projects must focus on a condition that falls within the mission of NINDS. It is expected that devices within the scope of this program either:

C. Entry criteria

For entry to the program, projects should have:

  • Comprehensive supporting data based on bench, in vitro, and/or in vivo models representative of the intended patient population and indication.
  • Identified one or more clinically meaningful device outcome measures based on input from key stakeholders (e.g., clinicians, patients, and caregivers) as well as supporting literature.
  • A compelling case for successful IRB approval for an NSR study. All regulatory approvals must be in place prior to the start of the R33 phase.

Applicants are encouraged, but not required, to consult with FDA via a Pre-Submission meeting, study risk designation request, and/or 513(g) submission prior to applying for funding through this grant mechanism. Applicants who do not have sufficiently relevant feedback from the FDA regarding all planned activities prior to application for funding may be expected to do so as the first milestone during the first year of the R61 phase of the award. In the event that FDA feedback is not consistent with the plans in the grant, program staff will evaluate the concerns and change of scope that would be needed and work with the investigators to determine the most appropriate course of action. 

Awards: 

Application budgets are not limited but need to reflect the actual needs of the proposed project. In all cases, applicants should propose a budget that is reasonable and appropriate for completion of the research project. 

Letter of Intent: 
60 days prior to the receipt date.
Full Proposal Submission Deadline: 

May 29, 2024; September 27, 2024

Contacts: 

Nick Langhals, PhD
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-1779
Email: NINDS-Devices@nih.gov