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Trailblazer Award for New and Early Stage Investigators (R21 Clinical Trial Optional)

ID: PA-25-169 • Type: Posted
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Description

This Trailblazer Award is an opportunity for NIH-defined New and Early Stage Investigators (https://grants.nih.gov/policy/early-investigators/index.htm) to pursue research programs that integrate engineering and the physical sciences with the life and/or biomedical sciences. A Trailblazer project may be exploratory, developmental, proof of concept, or high risk-high impact, and may be technology design-directed, discovery-driven, or hypothesis-driven. Importantly, applicants must propose research approaches for which there are minimal or no preliminary data. A distinct feature for this FOA is that no preliminary data are required, expected, or encouraged. However, if available, minimal preliminary data are allowed. Preliminary data are defined as material which the applicant has independently produced and not yet published in a peer-reviewed journal. All preliminary data should be clearly marked and limited to one-half page, which may include one figure. Applications including data more than one-half page or more than one figure will be considered noncompliant with the FOA instructions and will not go forward to review.
Background
The Trailblazer Award for New and Early Stage Investigators is an initiative by the National Institutes of Health (NIH) aimed at fostering innovative research that integrates engineering and physical sciences with life and biomedical sciences. This funding opportunity is designed specifically for NIH-defined New and Early Stage Investigators, encouraging them to explore high-risk, high-impact projects without the necessity of preliminary data. The goal is to catalyze transdisciplinary research approaches that can lead to significant advancements in biomedical investigation.

Grant Details
The Trailblazer Award allows applicants to pursue exploratory, developmental, proof of concept, or high-risk/high-impact projects. Key features include:

1) No preliminary data are required, expected, or encouraged; however, minimal preliminary data may be submitted if clearly marked and limited to one-half page including one figure.

2) Applications must propose research approaches with minimal or no preliminary data.

3) The award provides up to $400,000 in direct costs over a maximum of three years, with no more than $200,000 in direct costs allowed in any single year.

4) Projects should be innovative and address unmet biomedical research needs through new methods or technologies.

5) Applications proposing clinical trials are limited to early-stage trials (Phase I) focused on safety and feasibility.

Eligibility Requirements
Eligible applicants include higher education institutions (public/state controlled, private), nonprofits (with or without 501(c)(3) status), for-profit organizations (including small businesses), local/state/county governments, tribal governments, and other entities as specified. Applicants must meet the NIH definition of New or Early Stage Investigators. Applications from individuals from underrepresented groups in biomedical research are encouraged.

Period of Performance
The maximum project period for the Trailblazer Award is three years.

Grant Value
The total value of the grant is up to $400,000 in direct costs over a maximum period of three years.
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Overview

Agency
National Institutes of Health (NIH) [HHS]
Category of Funding
Health
Funding Instruments
Grant
Grant Program (CFDA)
93.286 - Discovery and Applied Research for Technological Innovations to Improve Human Health
93.866 - Aging Research
93.867 - Vision Research
Grant Category
Discretionary
Cost Sharing / Matching Requirement
False
Source
Grants.gov
On 1/8/25 the National Institutes of Health posted grant opportunity PA-25-169 for Trailblazer Award for New and Early Stage Investigators (R21 Clinical Trial Optional). The grant will be issued under grant program 93.286 Discovery and Applied Research for Technological Innovations to Improve Human Health.

Timing

Posted Date
Jan. 8, 2025, 12:00 a.m. EST
Closing Date
May 7, 2026, 12:00 a.m. EDT Past Due
Last Updated
June 16, 2025, 11:41 a.m. EDT
Version
2
Archive Date
June 6, 2026

Eligibility

Eligible Applicants
Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
Small businesses
Public housing authorities/Indian housing authorities
Native American tribal organizations (other than Federally recognized tribal governments)
For profit organizations other than small businesses
Private institutions of higher education
Public and State controlled institutions of higher education
Others (see text field entitled "Additional Information on Eligibility" for clarification)
Special district governments
City or township governments
Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
Independent school districts
Native American tribal governments (Federally recognized)
County governments
State governments
Additional Info
Other Eligible Applicants include the following: Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISISs); Eligible Agencies of the Federal Government; Faith-based or Community-based Organizations; Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Indian/Native American Tribal Governments (Other than Federally Recognized); Non-domestic (non-U.S.) Entities (Foreign Organizations); Regional Organizations; Tribally Controlled Colleges and Universities (TCCUs) ; U.S. Territory or Possession; Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply.Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Contacts

Contact
National Institutes of Health
Contact Email
grantsinfo@nih.gov
Email Description
See Section VII. Agency Contacts within the full opportunity announcement for all other inquires.
Contact Phone
(301) 402-2541
Additional Information
https://grants.nih.gov/grants/guide/pa-files/PA-25-169.html
Additional Information Site
http://grants.nih.gov/grants/guide/pa-files/PA-25-169.html

Documents

Posted documents for PA-25-169

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