Opportunity Information: Apply for PAR 25 323
The Stephen I. Katz Early Stage Investigator Research Project Grant is an NIH R01 funding opportunity (PAR-25-323) designed specifically for early stage investigators who want to pivot into a genuinely new line of work. The core idea is to encourage a clear change in research direction rather than a straightforward extension of an existing program. A defining feature of this opportunity is that it is meant for projects where preliminary results do not yet exist, and NIH explicitly requires that applications under this NOFO must not include preliminary data. To make that point concrete in the application, applicants also have to include a separate attachment that explains the change in research direction and why the proposed work represents a new path for the investigator.
Scientifically, the project has to align with the mission and program interests of one or more participating NIH Institutes and Centers. What makes this NOFO unusual relative to many basic science mechanisms is that it is reserved for basic experimental studies that involve humans and that fall under NIH rules as a clinical trial, while still being considered basic research. In other words, this is not a patient-oriented efficacy or implementation study aimed at testing a treatment, product, or service for a specific practical use. Instead, it supports prospective studies where human participants are assigned to different conditions and researchers manipulate one or more independent variables, then measure biomedical or behavioral outcomes to understand fundamental mechanisms or phenomena. The emphasis is on advancing foundational knowledge in humans, not on developing or evaluating a specific intervention intended for real-world deployment.
This also means applicants need to be careful about fit: studies that do not involve a prospective assignment to conditions, or that do not meet the NIH clinical trial definition, generally should not be submitted here. Likewise, studies that are not aimed at specific applications and also do not meet the clinical trial definition are directed to a different NIH pathway, typically a "Clinical Trial Not Allowed" NOFO. The takeaway is that this opportunity sits in a narrow but important niche: basic mechanistic experimentation in human participants that still triggers the clinical trial definition because of prospective assignment and outcome assessment.
In terms of who can apply, NIH lists a wide range of eligible applicant organizations across the public, private, nonprofit, and educational sectors. Eligible applicants include state, county, and city or township governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; nonprofits with and without 501(c)(3) status (as long as they are not higher education institutions in those specific categories); for-profit organizations (other than small businesses); and small businesses. It also includes federally recognized Native American tribal governments, tribal organizations that are not federally recognized, public housing authorities/Indian housing authorities, and additional categories such as faith-based or community-based organizations and various minority-serving institutions (including HBCUs, Hispanic-serving institutions, AANAPISI institutions, Alaska Native and Native Hawaiian serving institutions, and tribally controlled colleges and universities). U.S. territories or possessions are also included as eligible applicant types.
At the same time, NIH draws firm boundaries around foreign involvement for this NOFO. Non-domestic (non-U.S.) entities are not eligible to apply, non-domestic components of U.S. organizations are not eligible, and foreign components (as NIH defines them in the NIH Grants Policy Statement) are not allowed. Practically, that means the applicant organization must be U.S.-based, and the work cannot be structured to include foreign components as part of the funded project.
Administratively, the opportunity is issued by the National Institutes of Health as a discretionary grant mechanism under the R01 activity code, and it is tied to multiple CFDA numbers spanning different NIH Institutes and Centers. The opportunity record lists an original closing date of August 25, 2028, indicating a multi-year window during which applications can be submitted according to the NOFO schedule. The award ceiling and expected number of awards are not specified in the provided source details, so applicants would need to consult the full NOFO text and the relevant NIH Institute or Center guidance for budget expectations, project period norms, and any IC-specific considerations.Apply for PAR 25 323
- The National Institutes of Health in the education, environment, health, income security and social services sector is offering a public funding opportunity titled "Stephen I. Katz Early Stage Investigator Research Project Grant (R01 Basic Experimental Studies with Human Required)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.113, 93.121, 93.173, 93.242, 93.273, 93.313, 93.361, 93.393, 93.398, 93.846, 93.865, 93.866, 93.867, 93.879.
- This funding opportunity was created on 2025-08-25.
- Applicants must submit their applications by 2028-08-25.
- 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.
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FAQs: Stephen I. Katz Early Stage Investigator Research Project Grant (NIH R01, PAR-25-323)
What is PAR-25-323?
PAR-25-323 is the NIH Notice of Funding Opportunity (NOFO) for the Stephen I. Katz Early Stage Investigator Research Project Grant. It uses the R01 activity code and is designed for early stage investigators proposing a genuine pivot into a new research direction.
What is the main purpose of this funding opportunity?
The goal is to support early stage investigators who are making a clear change in research direction, rather than proposing a straightforward continuation or incremental extension of an existing research program.
Who is this grant intended for?
This opportunity is intended specifically for early stage investigators, with an emphasis on those shifting into a new line of work.
Does the proposed project need to be a new research direction for the investigator?
Yes. A defining expectation is that the project represents a genuinely new path for the investigator, not simply the next step of the investigator's current program.
Are preliminary data allowed in the application?
No. NIH explicitly requires that applications under this NOFO must not include preliminary data. The opportunity is meant for projects where preliminary results do not yet exist.
How do applicants demonstrate that they are changing research direction?
Applicants must include a separate attachment explaining the change in research direction and why the proposed work represents a new path for the investigator.
What kind of science must the project align with?
The project must align with the mission and program interests of one or more participating NIH Institutes and Centers.
Is this opportunity for clinical trials?
It supports basic experimental studies that involve humans and that fall under NIH rules as a clinical trial, while still being considered basic research.
What does "basic experimental studies involving humans" mean in this NOFO?
It refers to prospective studies in which human participants are assigned to different conditions, researchers manipulate one or more independent variables, and biomedical or behavioral outcomes are measured to understand fundamental mechanisms or phenomena.
Is this grant meant to test the effectiveness of a treatment or intervention?
No. The emphasis is not on patient-oriented efficacy, implementation, or evaluating a treatment, product, or service for a specific practical use. The emphasis is on advancing foundational knowledge in humans.
Does the study have to meet the NIH clinical trial definition?
Yes, fit is important. This NOFO sits in a narrow niche: basic mechanistic experimentation in human participants that still triggers the NIH clinical trial definition due to prospective assignment and outcome assessment.
What kinds of studies are generally not a fit for this NOFO?
Studies that do not involve prospective assignment to conditions, or that do not meet the NIH clinical trial definition, generally should not be submitted under this opportunity.
What if my project is basic research but does not meet the clinical trial definition?
The provided information indicates such studies are typically directed to a different NIH pathway, commonly a "Clinical Trial Not Allowed" NOFO.
What types of applicant organizations are eligible?
NIH lists a wide range of eligible U.S. applicant organizations across public, private, nonprofit, educational, and business sectors, including many government entities, higher education institutions, nonprofits, for-profits (other than small businesses), and small businesses.
Are state or local government entities eligible to apply?
Yes. Eligible applicants include state governments, county governments, and city or township governments, as well as special district governments.
Are schools and universities eligible to apply?
Yes. Eligible applicants include independent school districts, public and state-controlled institutions of higher education, and private institutions of higher education.
Are nonprofit organizations eligible to apply?
Yes. Eligible applicants include nonprofits with 501(c)(3) status and nonprofits without 501(c)(3) status, as long as they are not higher education institutions in the categories specified in the eligibility list.
Are for-profit organizations eligible to apply?
Yes. For-profit organizations (other than small businesses) are listed as eligible. Small businesses are also listed as eligible applicant types.
Are tribal governments and tribal organizations eligible to apply?
Yes. Eligibility includes federally recognized Native American tribal governments and tribal organizations that are not federally recognized.
Are public housing authorities eligible to apply?
Yes. Public housing authorities/Indian housing authorities are included in the eligible applicant types.
Are faith-based or community-based organizations eligible?
Yes. The eligibility list includes faith-based or community-based organizations.
Are minority-serving institutions included as eligible applicants?
Yes. The eligibility list includes a range of minority-serving institutions, including HBCUs, Hispanic-serving institutions, AANAPISI institutions, Alaska Native and Native Hawaiian serving institutions, and tribally controlled colleges and universities.
Are U.S. territories or possessions eligible?
Yes. U.S. territories or possessions are included in the eligible applicant types.
Are non-U.S. (foreign) organizations eligible to apply?
No. Non-domestic (non-U.S.) entities are not eligible to apply under this NOFO.
Can a U.S. organization include a non-U.S. component in the project?
No. Non-domestic components of U.S. organizations are not eligible, and foreign components (as defined by NIH) are not allowed.
What does the foreign component restriction mean in practical terms?
Based on the provided information, it means the applicant organization must be U.S.-based and the work cannot be structured to include foreign components as part of the funded project.
What funding mechanism is used for this opportunity?
This is an NIH discretionary grant opportunity using the R01 activity code.
Is the award ceiling or number of awards specified in the provided information?
No. The award ceiling and expected number of awards are not specified in the provided source details.
Where should applicants look for budget expectations and project period norms?
Applicants would need to consult the full NOFO text and relevant NIH Institute or Center guidance for budget expectations, typical project periods, and any Institute/Center-specific considerations.
How long is this opportunity open?
The opportunity record lists an original closing date of August 25, 2028, indicating a multi-year window during which applications can be submitted according to the NOFO schedule.
Is this opportunity connected to specific NIH Institutes and Centers?
Yes. The project must align with the mission and program interests of one or more participating NIH Institutes and Centers, and the opportunity is tied to multiple CFDA numbers spanning different NIH Institutes and Centers.
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