Notice of Intent to Publish a Funding Opportunity Announcement for BRAIN Initiative: Research Opportunities Using Invasive Neural Recording and Stimulating Technologies in the Human Brain (U01 Clinical Trial Required)
Notice Number:

Key Dates

Release Date:
July 20, 2021
Estimated Publication Date of Funding Opportunity Announcement:
November 01, 2021
First Estimated Application Due Date:
October 01, 2022
Earliest Estimated Award Date:
June 01, 2023
Earliest Estimated Start Date:
July 21, 2023
Related Announcements

RFA-NS-19-001 - BRAIN Initiative: Research Opportunities Using Invasive Neural Recording and Stimulating Technologies in the Human Brain (U01 Clinical Trial Required)

NOT-MH-19-010 - Notice of Data Sharing Policy for the BRAIN Initiative

Issued by

National Institute of Neurological Disorders and Stroke (NINDS)

National Eye Institute (NEI)

National Institute on Aging (NIA)

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

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 Center for Complementary and Integrative Health (NCCIH)

All applications to this funding opportunity announcement should fall within the mission of the Institutes/Centers. The following NIH Offices may co-fund applications assigned to those Institutes/Centers.

Office of Behavioral and Social Sciences Research (OBSSR)


This Notice informs the research community that the NIH BRAIN Initiative intends to reissue Funding Opportunity Announcement (FOA) BRAIN Initiative: Research Opportunities Using Invasive Neural Recording and Stimulating Technologies in the Human Brain (U01 Clinical Trial Required).

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 Fall 2021 with an expected application due date in Fall 2022.

This FOA will utilize the U01 activity code. Details of the planned FOA are provided below.

Research Initiative Details

Invasive surgical procedures provide the unique ability to record and stimulate neurons within precisely localized brain structures in humans. Human studies using invasive technology are often constrained by a limited number of patients and resources available to implement complex experimental protocols and are rarely aggregated in a manner that addresses research questions with appropriate statistical power. Therefore, this RFA seeks applications to assemble diverse, integrated, multi-disciplinary teams that cross boundaries of interdisciplinary collaboration to overcome these fundamental barriers and to investigate high-impact questions in human neuroscience. Projects should maximize opportunities to conduct innovative in vivo neuroscience research made available by direct access to brain recording and stimulating from invasive surgical procedures. Projects should employ approaches guided by specified theoretical constructs and quantitative, mechanistic models where appropriate.

Recipients will join a consortium work group, coordinated by the NIH, to identify consensus standards of practice, including neuroethical considerations, to collect and provide data for ancillary studies, and to aggregate and standardize data for dissemination among the wider scientific community.

This RFA will require that applications include a Plan for Enhancing Diverse Perspectives (PEDP) in the proposed research. When a PEDP is required, applications submitted without such a plan will be considered incomplete and will be withdrawn prior to peer review. Evaluation of the applicant’s PEDP will be made during the peer review stages as part of the scorable criteria and during programmatic reviews, and will be used to inform funding decisions. For more information on the PEDP, please visit

This RFA will also require that the Resource Sharing Plan complies with the policy outlined in NOT-MH-19-010.

Funding Information
Estimated Total Funding


Expected Number of Awards
Estimated Award Ceiling

Application budgets are not limited but need to reflect the actual needs of the proposed project. Awards are for five years of support.

Primary Assistance Listing Number(s)


Anticipated Eligible Organizations
Regional Organization
Public/State Controlled Institution of Higher Education
U.S. Territory or Possession
Private Institution of Higher Education
Non-domestic (non-U.S.) Entity (Foreign Organization)
Nonprofit with 501(c)(3) IRS Status (Other than Institution of Higher Education)
For-Profit Organization (Other than Small Business)
Small Business
Eligible Agencies of the Federal Government
State Government
Indian/Native American Tribal Government (Federally Recognized)
County governments
Independent school districts
Public housing authorities/Indian housing authorities
Indian/Native American Tribally Designated Organization (Native American tribal organizations (other than Federally recognized tribal governments)
Indian/Native American Tribal Government (Other than Federally Recognized)

Applications are not being solicited at this time. 


Please direct all inquiries to:

James Gnadt, PhD

National Institute of Neurological Disorders and Stroke (NINDS)


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices