Opportunity Information: Apply for PAR 21 039

The Stephen I. Katz Early Stage Investigator Research Project Grant is an NIH R01 funding opportunity (PAR-21-039) designed specifically for early stage investigators who want to launch a bold, genuinely new research direction. The core idea is to give an ESI room to pursue an innovative concept before they have the kind of pilot results that normally anchor an R01. Because of that goal, the FOA explicitly prohibits preliminary data in the application. In practice, this means the proposal needs to be compelling on the strength of the question, the conceptual framework, the rigor of the experimental design, and the investigator's ability to carry it out, rather than on previously collected supporting results.

Scientifically, this announcement targets basic experimental studies that involve humans and that meet the NIH definition of a clinical trial while still being considered basic research. The emphasis is on prospective studies in which human participants are assigned to different conditions and the researcher manipulates an independent variable to observe biomedical or behavioral outcomes. The intent is fundamental understanding: studies should be aimed at uncovering basic mechanisms or principles of human biology, behavior, or related phenomena, without being primarily driven by the near-term development or testing of a specific product, intervention, or applied process. If the work is instead oriented toward a specific application, such as product development or a clearly translational objective, NIH expects applicants to use a different FOA that is more appropriate to applied clinical trials (either "clinical trial required" or "clinical trial not allowed," depending on the circumstances).

Programmatically, proposed projects must align with the scientific missions and interests of one or more participating NIH Institutes and Centers. That means applicants should pay close attention to NIH institute priorities and fit, since alignment with an IC's mission is a basic expectation for responsiveness. Although the opportunity is framed as an R01, its distinguishing feature is the Stephen I. Katz mechanism's focus on enabling a high-risk pivot or fresh trajectory for ESIs, particularly where preliminary data do not yet exist and are not permitted to be included.

Eligibility is broad across U.S.-based organizations and includes many common applicant types: state, county, and local governments; special district governments; independent school districts; public and private institutions of higher education; federally recognized Native American tribal governments; public housing authorities/Indian housing authorities; tribal organizations that are not federally recognized; nonprofit organizations (both 501(c)(3) and non-501(c)(3)); for-profit organizations (other than small businesses) and small businesses; and other eligible entities. The FOA also explicitly highlights additional eligible applicant categories such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISI), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), eligible federal agencies, faith-based or community-based organizations, regional organizations, and U.S. territories or possessions. At the same time, non-U.S. institutions are not eligible to apply as applicant organizations, and non-U.S. components of U.S. organizations are not eligible to apply. However, foreign components may be included when allowable under NIH policy, consistent with the NIH Grants Policy Statement definition of a foreign component.

Administratively, the sponsoring agency is the National Institutes of Health, the instrument is a grant, and the activity category spans areas such as education, environment, health, income security, and social services as reflected in the listing. The opportunity was created on November 9, 2020, and the original closing date listed is December 28, 2023. The source information does not specify an award ceiling or the expected number of awards in the provided fields, so those details would typically need to be confirmed directly in the full FOA text or related NIH materials.

Overall, this FOA is best understood as an NIH pathway for ESIs to propose rigorous, prospective, experimentally controlled human research that is fundamentally mechanistic and discovery-oriented, while removing the usual expectation of preliminary data. It is intentionally structured to support a research reset or strategic shift early in a career, provided the work fits NIH institute missions and is framed as basic experimental science with human participants rather than applied clinical development.

  • 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 Humans 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, 93.213, 93.242, 93.273, 93.279, 93.307, 93.313, 93.361, 93.393, 93.394, 93.395, 93.396, 93.399, 93.846, 93.853, 93.865, 93.866, 93.867, 93.879.
  • This funding opportunity was created on 2020-11-09.
  • Applicants must submit their applications by 2023-12-28. (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 21 039

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Frequently Asked Questions (FAQs): Stephen I. Katz Early Stage Investigator Research Project Grant (NIH R01, PAR-21-039)

What is the Stephen I. Katz Early Stage Investigator Research Project Grant?

It is an NIH R01 funding opportunity (FOA PAR-21-039) designed for early stage investigators (ESIs) who want to launch a bold, genuinely new research direction. It is intended to support an early-career "pivot" or fresh trajectory, even when the investigator does not yet have pilot findings to support the idea.

What is the main purpose of this FOA compared to a typical R01?

The distinguishing feature is that it creates space for ESIs to pursue an innovative concept without the usual expectation of preliminary results. The application is expected to stand on the strength of the scientific question, conceptual framework, rigor of the design, and the investigator's ability to execute the work, rather than on previously collected supporting data.

Are preliminary data allowed in the application?

No. The FOA explicitly prohibits preliminary data in the application. The project must be justified through the importance of the question, the logic of the approach, and the rigor of the experimental plan rather than pilot results.

If preliminary data are not allowed, what should make the application compelling?

Based on the FOA description provided, applications should be compelling because they clearly articulate (1) a strong, important scientific question, (2) a sound conceptual framework, (3) rigorous and well-justified experimental design, and (4) evidence that the investigator is capable of carrying out the proposed work.

What kind of science is this FOA trying to support?

The announcement targets basic experimental studies that involve humans and that meet the NIH definition of a clinical trial while still being considered basic research. The emphasis is on mechanistic, discovery-oriented research aimed at fundamental understanding of human biology or behavior.

Does the proposed research have to involve human participants?

Yes. The FOA targets basic experimental studies that involve humans. The described focus is on prospective studies with human participants.

Does the research need to meet the NIH definition of a clinical trial?

Yes. The targeted projects are described as basic experimental studies involving humans that meet the NIH definition of a clinical trial, while still being classified as basic research.

What kinds of study designs are emphasized?

The FOA emphasizes prospective, experimentally controlled studies in which human participants are assigned to different conditions and the researcher manipulates an independent variable to observe biomedical or behavioral outcomes.

What outcomes are relevant under this FOA?

The description highlights biomedical or behavioral outcomes, observed as a result of experimentally manipulating an independent variable in a prospective human study.

Is the FOA intended for product development or near-term translational work?

No. The stated intent is fundamental understanding and discovery-oriented work. Projects should not be primarily driven by near-term development or testing of a specific product, intervention, or applied process.

What if my project is oriented toward a specific application or translational objective?

If the work is oriented toward a specific application (such as product development or a clearly translational objective), NIH expects applicants to use a different FOA that is more appropriate to applied clinical trials. The appropriate alternative would depend on the circumstances (for example, an FOA where a clinical trial is required or an FOA where a clinical trial is not allowed).

Do proposed projects need to fit a particular NIH Institute or Center (IC)?

Yes. Proposed projects must align with the scientific missions and interests of one or more participating NIH Institutes and Centers. Fit with an IC mission is described as a basic expectation for responsiveness.

Why is alignment with an NIH Institute or Center mission important here?

The opportunity expects the proposed project to match the mission and interests of at least one participating IC. Applicants are expected to pay close attention to institute priorities and fit, since responsiveness depends on that alignment.

Who is this opportunity designed for?

It is designed specifically for early stage investigators (ESIs), particularly those seeking to initiate a high-risk pivot or genuinely new research direction early in their careers.

Is this funding mechanism an R01?

Yes. The opportunity is framed as an NIH R01, with the Katz mechanism distinguishing it by emphasizing innovative early-stage directions and prohibiting preliminary data.

Who is the sponsoring agency and what type of funding instrument is this?

The sponsoring agency is the National Institutes of Health (NIH). The funding instrument is a grant.

What kinds of organizations are eligible to apply?

Eligibility is broad across U.S.-based organizations. Eligible applicant types include state, county, and local governments; special district governments; independent school districts; public and private institutions of higher education; federally recognized Native American tribal governments; public housing authorities/Indian housing authorities; tribal organizations that are not federally recognized; nonprofit organizations (both 501(c)(3) and non-501(c)(3)); for-profit organizations (other than small businesses) and small businesses; and other eligible entities.

Are minority-serving institutions and similar organizations explicitly included as eligible applicants?

Yes. The FOA explicitly highlights additional eligible categories such as Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISI); Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Tribally Controlled Colleges and Universities (TCCUs); eligible federal agencies; faith-based or community-based organizations; regional organizations; and U.S. territories or possessions.

Are non-U.S. institutions eligible to apply as applicant organizations?

No. Non-U.S. institutions are not eligible to apply as applicant organizations under the information provided.

Can a non-U.S. component of a U.S. organization apply?

No. Non-U.S. components of U.S. organizations are not eligible to apply as applicant organizations under the information provided.

Are foreign components allowed at all?

Foreign components may be included when allowable under NIH policy, consistent with the NIH Grants Policy Statement definition of a foreign component. This is different from a foreign institution serving as the applicant organization, which is not allowed.

When was this opportunity created and what closing date is listed?

The opportunity was created on November 9, 2020. The original closing date listed is December 28, 2023.

Does the provided information include an award ceiling or the expected number of awards?

No. The source information provided does not specify an award ceiling or the expected number of awards in the listed fields. Those details would typically need to be confirmed in the full FOA text or related NIH materials.

What activity categories are associated with this opportunity?

The activity category is listed as spanning areas such as education, environment, health, income security, and social services, as reflected in the listing.

How should I decide whether this FOA is the right fit for my proposed study?

Based on the description provided, this FOA is a good fit if your project is (1) led by an early stage investigator, (2) a bold new direction without preliminary data (and you can avoid including preliminary data), (3) a prospective basic experimental study in humans that meets the NIH definition of a clinical trial, (4) focused on fundamental mechanisms rather than near-term product development, and (5) aligned with the mission of a participating NIH Institute or Center.

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