Stephen I. Katz Early Stage Investigator Research Project Grant (R01 Clinical Trial Not Allowed) | PAR 24 075

Opportunity Information: Apply for PAR 24 075

The Stephen I. Katz Early Stage Investigator Research Project Grant is an NIH funding opportunity (PAR-24-075) that uses the R01 mechanism to help early stage investigators launch a genuinely new line of research. The central idea is to back high-impact, innovative projects that represent a clear change in the applicant's research direction, specifically in situations where preliminary results do not yet exist. In fact, the program is intentionally designed for projects at an earlier conceptual stage than many traditional R01 applications, and it sets an unusual rule: applications must not include preliminary data. Instead of trying to strengthen the application with early findings, applicants are expected to make a strong case based on the importance of the problem, the novelty of the approach, and the logic and feasibility of the proposed methods.

A defining requirement of this opportunity is that the application must include a separate attachment explaining the change in research direction. That attachment is important because the grant is not simply meant to fund the next incremental step in an investigator's current trajectory. NIH is looking for a thoughtful pivot into a new area, question, model system, or conceptual framework that still fits the applicant's overall expertise and potential but clearly marks a departure from what they have already been doing. In practical terms, a competitive application would typically articulate what the investigator has done previously, what new direction they are proposing now, why this shift is scientifically compelling, and how the investigator will be positioned to succeed in the new space despite the absence of preliminary data.

This is an R01 "Clinical Trial Not Allowed" opportunity, which means the proposed research must not include a clinical trial as defined by NIH policy. Applicants can generally still propose a wide range of biomedical, behavioral, or health-related research, but they need to ensure the work does not cross the line into an NIH-defined clinical trial (for example, prospectively assigning human participants to an intervention to study effects on health-related outcomes). Anyone considering human-subjects work would need to be careful to align the study design with the "not allowed" restriction.

Eligibility is broad and includes many types of U.S.-based organizations and governmental entities. Eligible applicants listed include state, county, and city governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments and other tribal organizations; public housing authorities/Indian housing authorities; nonprofits (both 501(c)(3) and non-501(c)(3)); for-profit organizations other than small businesses; and small businesses. The opportunity also explicitly highlights additional eligible categories such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, eligible federal agencies, regional organizations, Indian/Native American Tribal Governments (other than federally recognized), and U.S. territories or possessions.

On the other hand, foreign organizations are not eligible to apply as applicant institutions, and non-U.S. components of U.S. organizations are not eligible to apply. However, "foreign components" are allowed when they meet the NIH definition in the NIH Grants Policy Statement, meaning a U.S.-based applicant can include certain kinds of international collaboration or performance sites if they are structured as allowable foreign components and properly justified under NIH rules.

NIH is the sponsoring agency, and the opportunity is categorized as a discretionary grant program spanning multiple NIH CFDA numbers (as listed in the source data), reflecting that it may be supported across a range of NIH institutes and centers depending on scientific area. The original closing date provided is 2026-12-28. Award ceiling and expected award counts are not specified in the provided data, so applicants would need to consult the full NOFO and institute-specific guidance for budgeting expectations, typical project periods, and any institute participation details.

Overall, this NOFO is best read as a deliberate encouragement to take a calculated scientific risk early in an independent career: propose a real pivot, do not lean on preliminary data, and clearly explain why the new direction is important, innovative, and feasible, with a strong, well-reasoned plan that fits within an R01 scope while avoiding any clinical trial elements.

• The National Institutes of Health in the education, food and nutrition, health, income security and social services sector is offering a public funding opportunity titled "Stephen I. Katz Early Stage Investigator Research Project Grant (R01 Clinical Trial Not Allowed)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.172, 93.233, 93.273, 93.279, 93.286, 93.351, 93.361, 93.393, 93.398, 93.837, 93.838, 93.839, 93.840, 93.846, 93.847, 93.855, 93.865, 93.867, 93.879.
• This funding opportunity was created on 2023-12-22.
• Applicants must submit their applications by 2026-12-28. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.

Apply for PAR 24 075

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