Notice of Intent to Publish a Funding Opportunity Announcement for Translational Neural Devices Program (U44)

Notice Number: NOT-NS-17-023

Key Dates
Release Date: April 25, 2017

Estimated Publication Date of Announcement:  July 2017 
First Estimated Application Due Date:  October 2017 
Earliest Estimated Award Date:  February 2018 
Earliest Estimated Start Date:  June 2018 

Related Announcements
None

Issued by
National Institute of Neurological Disorders and Stroke (NINDS)

Purpose

The National Institute of Neurological Disorders and Stroke (NINDS), intends to promote a new initiative by publishing a Funding Opportunity Announcement (FOA) to solicit applications for milestone-driven projects involving translational activities and small clinical studies to advance the development of therapeutic and diagnostic devices for disorders that affect the nervous system.

This Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects. 

The FOA is expected to be published in July 2017 with an expected application due date in October 2017.

This FOA will utilize the U44 activity code. Details of the planned FOA are provided below.

Research Initiative Details

This Notice encourages SBIR-eligible small businesses with expertise and insights into neurotherapeutic and neurodiagnostic devices to begin to consider applying for this new FOA. This initiative is a successor to the prior NINDS Cooperative Research to Enable and Advance Translational Enterprises (CREATE Devices) program that ended in early 2017.

The Fast-Track phased U44 cooperative agreement mechanism is milestone-driven and involves NIH program staff's participation in developing the project plan, monitoring research progress, and appropriate go/no-go decision-making. All projects will have two phases, Phase I and Phase II. The initial phase will support translational device activities leading to submission of an Investigational Device Exemption (IDE) to the US Food and Drug Administration (FDA) or Institutional Review Board (IRB) application for a Non-Significant Risk (NSR) study. All projects will start at Phase I but the duration of Phase I will depend on the maturity of the project at entry. Only successful Phase I projects that have met all milestones and other requirements will be eligible for transition to Phase II after NIH administrative review. The Phase II will support an Early Feasibility Study or a small clinical study.

It is expected that devices within the scope of this program either:

  • are very close to the 'final system' and manufactured using very close to the same manufacturing process as the device to be marketed or studied in a larger clinical trial following the completion of this project, or 
  • require early feasibility clinical data to inform the final device design or manufacturing processes.

It is also expected that devices within the scope of this program have either received Pre-Submission feedback from the FDA or will conduct a Pre-Submission to the FDA in the first year of Phase I.

The expectations of the program are in line with those of industry in regards to advancing devices through the developmental pipeline. As such an inherent high rate of attrition is expected within this program.

Applicants are strongly encouraged to consult with NINDS program staff as plans for an application are being developed.

APPLICATIONS ARE NOT BEING SOLICITED AT THIS TIME.

Inquiries

Please direct all inquiries to:

Stephanie Fertig, MBA
National Institute of Neurological Disorders and Stroke (NINDS
Telephone: 301-496-1779
Email: fertigs@ninds.nih.gov

Nick Langhals, PhD
National Institute of Neurological Disorders and Stroke (NINDS
Telephone: 301-496-1447
Email: nick.langhals@nih.gov