Notice of Clarification of the Device Requirement for "BRAIN Initiative: Next-Generation Invasive Devices for Recording and Modulation in the Human Central Nervous System (U44)"

Notice Number: NOT-NS-18-006

Key Dates
Release Date: August 18, 2017

Related Announcements

RFA-NS-17-007

Issued by
National Eye Institute (NEI)
National Institute on Aging (NIA)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute on Deafness and Other Communication Disorders (NIDCD)
National Institute on Drug Abuse (NIDA)
National Institute of Mental Health (NIMH)
National Institute of Neurological Disorders and Stroke (NINDS)
National Center for Complementary and Integrative Health (NCCIH)

Purpose

The purpose of this Notice is to add language concerning device-based study requirements for RFA-NS-17-007.  It is expected that proposed devices will include the ability to synchronize peripheral ambulatory behavioral signals with recorded brain signals.

The current language reads:

Part 2.  Full Text of Announcement

Section 1. Funding Opportunity Description

Objectives of this FOA

All projects must have two phases, Phase I and Phase II, using the Fast-track mechanism.  The initial Phase I will support non-clinical testing toward filing of an IDE for an SR study or obtaining IRB approval for an NSR clinical study.  All projects will start at Phase I, and the length of Phase I will depend on the maturity of the project at entry.  Only those Phase I projects that have met specific criteria (see below) will transition to the subsequent Phase II after NIH administrative review.  The Phase II will support a small clinical study.

This FOA is milestone-driven and involves NIH program staff's participation in developing the project plan, monitoring the research progress, and making go/no-go decisions.  NIH staff will also provide assistance to academic investigators in familiarizing them with the clinical device development process and the criteria needed to advance therapeutic leads and diagnostics to the clinic.  The expectations of the program are in line with those of industry in regards to advancing devices through the translational development pipeline.  As such, an inherent high rate of attrition is expected within this program.

Scope of the FOA
U44 Phase I Scope
Examples
Examples of studies that can be proposed during the non-clinical Phase I include, but are not limited to:

  • Non-GLP (Good Laboratory Practice) animal studies to develop surgical techniques relevant to the device, define relevant therapeutic parameters, and refine device design in preparation for subsequent GLP testing for regulatory approval
  • In vitro and animal testing to meet FDA recognized ISO/ASTM Standards
  • Activities to become GMP (Good Manufacturing Practice) compliant
  • Activities to bring the development process under Design and Quality Systems Control
  • Device, software and firmware design verification and validation activities
  • GLP compliant large animal model safety and/or testing of an implanted device

The language has been modified and now reads:

Part 2. Full Text of Announcement

Section 1. Funding Opportunity Description

Objectives of this FOA

All projects must have two phases, Phase I and Phase II, using the Fast-track mechanism.  The initial Phase I will support non-clinical testing toward filing of an IDE for an SR study or obtaining IRB approval for an NSR clinical study.  All projects will start at Phase I, and the length of Phase I will depend on the maturity of the project at entry.  Only those Phase I projects that have met specific criteria (see below) will transition to the subsequent Phase II after NIH administrative review.  The Phase II will support a small clinical study.

Proposed next generation devices are strongly encouraged to incorporate the ability to synchronize peripheral, ambulatory behavioral data signals.  These signals must be synchronized in real time, but analysis may be done in an online or offline manner.  Data does not have to be stored on board by the device but may be streamed out, as long as it does not interfere significantly with the naturalistic behavior (i.e., a participant must not be required to carry around a large personal computer with them for synchronization to occur).  Behavioral signals may be those captured by a phone (GPS, keyboard usage, accelerometer, etc.), a smartwatch, or related peripheral behavioral capture device.

This FOA is milestone-driven and involves NIH program staff's participation in developing the project plan, monitoring the research progress, and making go/no-go decisions.  NIH staff will also provide assistance to academic investigators in familiarizing them with the clinical device development process and the criteria needed to advance therapeutic leads and diagnostics to the clinic.  The expectations of the program are in line with those of industry in regards to advancing devices through the translational development pipeline.  As such, an inherent high rate of attrition is expected within this program.

Scope of the FOA
U44 Phase I Scope
Examples of studies that can be proposed during the non-clinical Phase I include, but are not limited to:

  • Non-GLP (Good Laboratory Practice) animal studies to develop surgical techniques relevant to the device, define relevant therapeutic parameters, and refine device design in preparation for subsequent GLP testing for regulatory approval
  • In vitro and animal testing to meet FDA recognized ISO/ASTM Standards
  • Activities to become GMP (Good Manufacturing Practice) compliant
  • Activities to bring the development process under Design and Quality Systems Control
  • Device, software and firmware design verification and validation activities
  • Device, software, and firmware design activities related to synchronization naturalistic behavioral data with neural recordings
  • GLP compliant large animal model safety and/or testing of an implanted device

All other aspects of this FOA remain unchanged

Inquiries

Please direct all inquiries to:

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