Notice of Clarification for Submission of Materials Related to Communications with FDA for RFA-NS-18-012 "Translational Neural Devices (U44 Clinical Trial Required)"

Notice Number: NOT-NS-18-064

Key Dates
Release Date:   June 22, 2018

Related Announcements
RFA-NS-18-012

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

Purpose

The purpose of this Notice is to clarify submission of materials related to Communications with the FDA for RFA-NS-18-012 "Translational Neural Devices (U44 Clinical Trial Required)".

The current language reads
 
Section 4 Protocol Synopsis
 
4.6 Will the study use an FDA-regulated intervention?
 
4.6.a. If yes, describe the availability of Investigational Product (IP) and Investigational New Drug (IND)/Investigational Device Exemption (IDE) status:
 
Communications with FDA:

  • Large animal safety studies are often required by the FDA to support an IDE. Applicants should include a large animal GLP safety study conducted on the full-final device system using the final manufacturing process intended to support the IDE. If a large animal safety study is not required by the FDA for an IDE, or a test of the full final system using final design and manufacturing processes is not required, applicants should include a communication from the FDA clearly stating this is the case in the form of a response to a Pre-Submission. If these studies are proposed, but ultimately not needed, program staff will work with the investigators to remove the relevant milestones and associated costs of these activities from the award
 
The language has been modified and now reads:
 
Section 4 Protocol Synopsis
 
4.6 Will the study use an FDA-regulated intervention?
 
4.6.a. If yes, describe the availability of Investigational Product (IP) and Investigational New Drug (IND)/Investigational Device Exemption (IDE) status:
 
Communications with FDA:
  • Applicants should include minutes from all pre-submission meetings, notice of IDE, risk determination, email communications, and other relevant documentation. This material should only be submitted in section 4.6.a of the application or as post-submission material.  
  • Large animal safety studies are often required by the FDA to support an IDE. Applicants should include a large animal GLP safety study conducted on the full-final device system using the final manufacturing process intended to support the IDE. If a large animal safety study is not required by the FDA for an IDE, or a test of the full final system using final design and manufacturing processes is not required, applicants should include a communication from the FDA clearly stating this is the case in the form of a response to a Pre-Submission. If these studies are proposed, but ultimately not needed, program staff will work with the investigators to remove the relevant milestones and associated costs of these activities from the awa
?All other aspects of this FOA remain the same.

Inquiries

Please direct all inquiries to:

Kari Ashmont, Ph.D.
National Institute of Neurological Disorders and Stroke
Telephone: 301-496-1447
Email: kari.ashmont@nih.gov
 
Stephanie Fertig, M.B.A.
National Institute of Neurological Disorders and Stroke
Telephone: 301-496-1779
Email: fertigs@ninds.nih.gov
 
Nick Langhals, Ph.D.
National Institute of Neurological Disorders and Stroke
Telephone: 301-496-1447
Email: nick.langhals@nih.gov