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Simpler Grants

No. RFA-NS-25-022 · National Institutes of Health

Open

BRAIN Initiative: Clinical Studies to Advance Next-Generation Devices for Recording and Modulation in the Human Central Nervous System (UH3 Clinical Trial Optional)

grants.gov listing Full announcement (NOFO)
Dealbreakers No cost share required Audit: not stated Reimbursement-only: not stated
Award range
Not specified
Expected awards
Not specified
Application deadline
Sep 28, 2026 26 days left
Posted
Nov 5, 2024
Last verified
Yesterday

At a glance

AI summary

This funding opportunity supports small, milestone-driven clinical studies of next-generation recording and/or stimulation devices for the human central nervous system, aimed at diagnosing or treating a CNS disorder and improving understanding of the human brain. It is for significant-risk studies that need FDA IDE approval and may include first-in-human or early-stage studies, including studies of already approved devices used in a new indication, target, or patient population. Eligible applicants include higher education institutions, nonprofits, and for-profit organizations, and clinical trials are optional. NIH expects about $10 million per year for an estimated 5 to 7 awards, with budgets that rarely exceed $1.5 million in direct costs per year and a total project period of up to 5 years. Projects must focus on a single CNS condition within the mission of one of the participating BRAIN Initiative institutes, and applications for non-significant-risk studies, animal studies, basic disease-mechanism research, or devices for use outside the CNS are not responsive.

AI-generated summary — verify against the announcement

What it funds

  • Education
  • Health
  • Income Security and Social Services
  • Research & Discovery
  • Researchers & Scholars
  • Biomedical & Disease Research
Official description from grants.gov

The purpose of this announcement is to encourage investigators to pursue a small clinical trial to obtain critical information necessary to advance recording and/or stimulating devices to treat central nervous system disorders and better understand the human brain (e.g., Early Feasibility Study). Clinical studies supported may consist of acute or short-term procedures that are deemed Non-Significant Risk (NSR) by an Institutional Review Board (IRB), or Significant Risk (SR) studies that require an Investigational Device Exemption (IDE) from the FDA, such as chronic implants. The clinical trial should provide data to answer key questions about the function or final design of a device. This final device design may require most, if not all, of the non-clinical testing on the path to more advanced clinical trials and market approval. The clinical trial is expected to provide information that cannot be practically obtained through additional non-clinical assessments (e.g., bench top or animal studies) due to the novelty of the device or its intended use. Activities supported by this Funding Opportunity include a small clinical trial to answer key questions about the function or final design of a device.As part of the BRAIN Initiative, NIH has initiated a Public-Private Partnership Program (BRAIN PPP) that includes agreements (Memoranda of Understanding, MOU) with a number of device manufacturers willing to make such devices available, including devices and capabilities not yet market approved but appropriate for clinical research. In general it is expected that the devices' existing safety and utility data will be sufficient to enable new IRB NSR or FDA IDE approval without need for significant additional non-clinical data. For more information on the BRAIN PPP, see http://braininitiative.nih.gov/BRAIN_PPP/index.htm

Who can apply

  • City or township governments
  • County governments
  • For-profit organizations other than small businesses
  • Independent school districts
  • Native American tribal governments (Federally recognized)
  • Native American tribal organizations (other than Federally recognized)
  • Nonprofits with 501(c)(3) status (other than higher education)
  • Nonprofits without 501(c)(3) status (other than higher education)
  • Others
  • Private institutions of higher education
  • Public and State controlled institutions of higher education
  • Public housing authorities / Indian housing authorities
  • Small businesses
  • Special district governments
  • State governments
Geographic restriction None found in the announcement — likely nationwide

Program history

USASpending.gov

Assistance listing 93.173 · Research Related to Deafness and Communication Disorders

Real awards this federal program has made — the whole assistance listing (93.173), not just this notice.

Fiscal year Awards Median award Middle half
FY 2026 (so far) 170 $416,419 $134,042 – $648,731
FY 2025 238 $418,797 $187,647 – $1,008,401
FY 2024 283 $464,268 $152,978 – $1,268,772
FY 2023 260 $689,002 $272,758 – $1,868,608
FY 2022 286 $570,000 $145,264 – $2,113,099
FY 2021 246 — —

Dollar figures are based on the 1,000 most recent awards we store, not all 1,483 — award counts are complete.

Who wins it Higher education (1,127), Nonprofit (192), Business (83) of 1,483 awards — categories can overlap.
Top states MA (107) · CA (101) · NY (89) · PA (78) · MD (30)
Largest recent awards
  1. REGENTS OF THE UNIVERSITY OF MINNESOTA $4,621,171 · FY 2022
  2. UNIVERSITY OF ARKANSAS FOR MEDICAL SCIENCES $4,589,310 · FY 2023
  3. THE JOHNS HOPKINS UNIVERSITY $4,474,844 · FY 2022
  4. OREGON HEALTH & SCIENCE UNIVERSITY $3,863,432 · FY 2022
  5. THE LELAND STANFORD JUNIOR UNIVERSITY $3,579,023 · FY 2022

Source: USASpending.gov · refreshed Aug 16, 2026

Assistance listing 93.213 · Research and Training in Complementary and Integrative Health

Real awards this federal program has made — the whole assistance listing (93.213), not just this notice.

Fiscal year Awards Median award Middle half
FY 2026 (so far) 58 $441,813 $190,230 – $676,906
FY 2025 51 $472,500 $321,065 – $1,329,943
FY 2024 100 $562,397 $286,558 – $1,285,052
FY 2023 92 $695,557 $380,313 – $1,709,004
FY 2022 94 $715,153 $419,983 – $1,985,928
FY 2021 92 $1,686,420 $625,217 – $3,082,386
Who wins it Higher education (342), Nonprofit (97), Business (33) of 487 awards — categories can overlap.
Top states CA (77) · MA (59) · NY (29) · NC (12) · IL (11)
Largest recent awards
  1. REGENTS OF THE UNIVERSITY OF MINNESOTA $21,646,919 · FY 2022
  2. UNIVERSITY OF FLORIDA $11,192,369 · FY 2022
  3. DUKE UNIVERSITY $7,025,837 · FY 2022
  4. THE RAND CORPORATION $6,237,409 · FY 2023
  5. THE SPAULDING REHABILITATION HOSPITAL CORPORATION $5,991,655 · FY 2023

Source: USASpending.gov · refreshed Aug 21, 2026

Assistance listing 93.242 · Mental Health Research Grants

Real awards this federal program has made — the whole assistance listing (93.242), not just this notice.

Fiscal year Awards Median award Middle half
FY 2026 (so far) 491 $451,000 $167,702 – $811,948
FY 2025 600 $731,738 $320,544 – $1,460,736
FY 2024 883 — —
FY 2023 898 — —
FY 2022 986 — —
FY 2021 945 — —

Dollar figures are based on the 1,000 most recent awards we store, not all 4,803 — award counts are complete.

Who wins it Higher education (3,532), Nonprofit (816), Business (215) of 4,803 awards — categories can overlap.
Top states CA (166) · NY (127) · MA (104) · PA (79) · IL (22)
Largest recent awards
  1. MASSACHUSETTS INSTITUTE OF TECHNOLOGY $21,714,815 · FY 2025
  2. OHIO STATE UNIVERSITY, THE $19,515,757 · FY 2025
  3. ALBERT EINSTEIN COLLEGE OF MEDICINE $18,270,924 · FY 2025
  4. DUKE UNIVERSITY $15,039,330 · FY 2025
  5. ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI $12,007,972 · FY 2026

Source: USASpending.gov · refreshed Aug 6, 2026

Assistance listing 93.273 · Alcohol Research Programs

Real awards this federal program has made — the whole assistance listing (93.273), not just this notice.

Fiscal year Awards Median award Middle half
FY 2026 (so far) 100 $308,491 $157,932 – $601,291
FY 2025 175 $440,566 $194,934 – $1,114,948
FY 2024 237 $420,927 $153,632 – $1,110,810
FY 2023 327 $619,032 $350,328 – $1,806,361
FY 2022 314 $897,120 $369,477 – $2,547,224
FY 2021 274 — —

Dollar figures are based on the 1,000 most recent awards we store, not all 1,427 — award counts are complete.

Who wins it Higher education (1,103), Nonprofit (187), Business (75) of 1,427 awards — categories can overlap.
Top states CA (118) · NC (58) · NY (57) · PA (41) · TX (40)
Largest recent awards
  1. THE JOHNS HOPKINS UNIVERSITY $36,249,682 · FY 2022
  2. THE TRUSTEES OF COLUMBIA UNIVERSITY IN THE CITY OF NEW YORK $9,079,530 · FY 2022
  3. BOARD OF REGENTS OF THE UNIVERSITY OF NEBRASKA $6,335,676 · FY 2023
  4. VANDERBILT UNIVERSITY $5,361,769 · FY 2024
  5. LOHOCLA RESEARCH CORP $5,128,513 · FY 2022

Source: USASpending.gov · refreshed Aug 6, 2026

Assistance listing 93.279 · Drug Use and Addiction Research Programs

Real awards this federal program has made — the whole assistance listing (93.279), not just this notice.

Fiscal year Awards Median award Middle half
FY 2026 (so far) 428 $422,523 $183,034 – $700,682
FY 2025 588 $709,054 $348,214 – $1,489,059
FY 2024 714 — —
FY 2023 724 — —
FY 2022 740 — —
FY 2021 606 — —

Dollar figures are based on the 1,000 most recent awards we store, not all 3,800 — award counts are complete.

Who wins it Higher education (2,743), Nonprofit (534), Business (366) of 3,800 awards — categories can overlap.
Top states CA (130) · MA (90) · NY (86) · PA (72) · MD (56)
Largest recent awards
  1. FLORIDA INTERNATIONAL UNIVERSITY $7,372,834 · FY 2025
  2. BETH ISRAEL DEACONESS MEDICAL CENTER, INC. $7,081,684 · FY 2025
  3. UNIVERSITY OF WASHINGTON $7,003,822 · FY 2025
  4. REACX PHARMACEUTICALS, INC. $6,900,000 · FY 2025
  5. WORCESTER POLYTECHNIC INSTITUTE $6,889,914 · FY 2025

Source: USASpending.gov · refreshed Aug 18, 2026

Assistance listing 93.286 · Discovery and Applied Research for Technological Innovations to Improve Human Health

Real awards this federal program has made — the whole assistance listing (93.286), not just this notice.

Fiscal year Awards Median award Middle half
FY 2026 (so far) 127 $276,000 $117,190 – $583,962
FY 2025 240 $555,997 $296,281 – $1,161,259
FY 2024 231 $589,216 $349,987 – $1,434,349
FY 2023 252 $652,889 $409,140 – $1,745,975
FY 2022 303 $691,306 $420,665 – $2,168,108
FY 2021 285 — —

Dollar figures are based on the 1,000 most recent awards we store, not all 1,438 — award counts are complete.

Who wins it Higher education (1,055), Nonprofit (237), Business (99) of 1,438 awards — categories can overlap.
Top states CA (133) · MA (128) · NY (69) · PA (27) · NC (26)
Largest recent awards
  1. UNIVERSITY OF ILLINOIS $6,543,053 · FY 2022
  2. ALLEN INSTITUTE $6,281,935 · FY 2023
  3. REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE $5,888,124 · FY 2024
  4. WASHINGTON UNIVERSITY, THE $4,858,373 · FY 2024
  5. REGENTS OF THE UNIVERSITY OF CALIFORNIA, THE $4,329,771 · FY 2023

Source: USASpending.gov · refreshed Aug 18, 2026

Assistance listing 93.853 · Extramural Research Programs in the Neurosciences and Neurological Disorders

Real awards this federal program has made — the whole assistance listing (93.853), not just this notice.

Fiscal year Awards Median award Middle half
FY 2026 (so far) 654 $405,461 $120,825 – $587,738
FY 2025 923 $491,085 $157,949 – $1,077,840
FY 2024 1,031 — —
FY 2023 1,194 — —
FY 2022 1,228 — —
FY 2021 1,132 — —

Dollar figures are based on the 1,000 most recent awards we store, not all 6,162 — award counts are complete.

Who wins it Higher education (4,669), Nonprofit (990), Business (259) of 6,162 awards — categories can overlap.
Top states CA (153) · NY (99) · MA (93) · PA (74) · TX (39)
Largest recent awards
  1. THE LELAND STANFORD JUNIOR UNIVERSITY $5,747,701 · FY 2025
  2. YALE UNIV $4,888,497 · FY 2025
  3. MAYO CLINIC $3,746,535 · FY 2026
  4. REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE $3,153,019 · FY 2025
  5. UNIVERSITY OF CALIFORNIA, LOS ANGELES $3,109,857 · FY 2025

Source: USASpending.gov · refreshed Aug 23, 2026

Assistance listing 93.865 · Child Health and Human Development Extramural Research

Real awards this federal program has made — the whole assistance listing (93.865), not just this notice.

Fiscal year Awards Median award Middle half
FY 2026 (so far) 386 $392,826 $79,188 – $593,582
FY 2025 665 $452,972 $178,000 – $1,225,547
FY 2024 785 — —
FY 2023 835 — —
FY 2022 799 — —
FY 2021 764 — —

Dollar figures are based on the 1,000 most recent awards we store, not all 4,234 — award counts are complete.

Who wins it Higher education (3,137), Nonprofit (693), Business (224) of 4,234 awards — categories can overlap.
Top states CA (103) · MA (87) · PA (75) · NY (62) · MI (34)
Largest recent awards
  1. PRESIDENT AND FELLOWS OF HARVARD COLLEGE $16,115,056 · FY 2025
  2. UNIVERSITY OF MIAMI $15,385,183 · FY 2025
  3. UNIVERSITY OF WASHINGTON $6,635,347 · FY 2025
  4. GEORGE WASHINGTON UNIVERSITY (THE) $5,117,920 · FY 2025
  5. RESEARCH TRIANGLE INSTITUTE $4,847,747 · FY 2025

Source: USASpending.gov · refreshed Aug 23, 2026

Assistance listing 93.866 · Aging Research

Real awards this federal program has made — the whole assistance listing (93.866), not just this notice.

Fiscal year Awards Median award Middle half
FY 2026 (so far) 795 $493,972 $248,999 – $713,195
FY 2025 1,033 $643,089 $467,538 – $1,733,010
FY 2024 1,560 — —
FY 2023 1,539 — —
FY 2022 1,715 — —
FY 2021 1,595 — —

Dollar figures are based on the 1,000 most recent awards we store, not all 8,237 — award counts are complete.

Who wins it Higher education (6,015), Nonprofit (1,370), Business (538) of 8,237 awards — categories can overlap.
Top states CA (153) · NY (110) · MA (100) · TX (57) · PA (41)
Largest recent awards
  1. REGENTS OF THE UNIVERSITY OF MICHIGAN $15,345,206 · FY 2026
  2. UNIVERSITY OF UTAH $10,793,501 · FY 2025
  3. THE TRUSTEES OF COLUMBIA UNIVERSITY IN THE CITY OF NEW YORK $10,223,348 · FY 2026
  4. SUTTER BAY HOSPITALS $9,466,491 · FY 2025
  5. TUFTS MEDICAL CENTER PARENT, INC. $8,296,115 · FY 2026

Source: USASpending.gov · refreshed Aug 23, 2026

Assistance listing 93.867 · Vision Research

Real awards this federal program has made — the whole assistance listing (93.867), not just this notice.

Fiscal year Awards Median award Middle half
FY 2026 (so far) 189 $440,263 $132,837 – $633,742
FY 2025 309 $464,903 $260,661 – $1,026,742
FY 2024 408 $630,967 $342,920 – $1,431,708
FY 2023 401 $771,099 $422,359 – $1,867,311
FY 2022 391 — —
FY 2021 394 — —

Dollar figures are based on the 1,000 most recent awards we store, not all 2,092 — award counts are complete.

Who wins it Higher education (1,564), Nonprofit (300), Business (168) of 2,092 awards — categories can overlap.
Top states CA (182) · NY (96) · MA (90) · MD (48) · TX (48)
Largest recent awards
  1. UNIVERSITY OF CALIFORNIA, SAN DIEGO $8,283,963 · FY 2024
  2. REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE $5,256,090 · FY 2023
  3. OHIO STATE UNIVERSITY, THE $4,539,043 · FY 2025
  4. ALLEN INSTITUTE $4,260,011 · FY 2025
  5. THE GENERAL HOSPITAL CORPORATION $4,026,010 · FY 2024

Source: USASpending.gov · refreshed Aug 23, 2026