Opportunity Information: Apply for PA 25 123

The National Institutes of Health (NIH) is offering a discretionary grant opportunity titled "Epidemiologic Research on Emerging Risk Factors and Liver Cancer Susceptibility (R21 Clinical Trial Not Allowed)" under Funding Opportunity Number PA 25 123 (CFDA 93.393). The goal of this announcement is to support early-stage, innovative epidemiologic studies that test new hypotheses about what is driving liver cancer risk in the United States, with a clear emphasis on emerging risk factors and how they may interact with well-established causes such as viral hepatitis. The FOA focuses on liver cancer broadly, including hepatocellular carcinoma as well as other histologic subtypes, and it is designed to stimulate creative, hypothesis-driven research that can open up new directions for prevention and risk stratification.

At its core, this opportunity is aimed at epidemiology, meaning studies that use population-based data, cohorts, registries, biospecimens linked to health data, or other human data resources to understand patterns, causes, and susceptibility. NIH is specifically encouraging research on emerging biological, environmental, and social risk factors. That can include newer or rapidly changing exposures (for example, shifts in metabolic health and obesity-related pathways, evolving environmental contaminants, changing patterns of medication or substance use, or social and structural determinants that influence exposure, diagnosis, and outcomes). A central theme is interplay: applicants are encouraged to look at how these newer factors combine with established risks like chronic hepatitis B or C infection, potentially altering risk levels, changing disease trajectories, or creating distinct high-risk subgroups that could be targeted for screening or prevention.

The mechanism is an R21, which is NIH's exploratory/developmental grant format. In practical terms, that signals support for projects that are novel, potentially high-impact, and may be earlier in development than a larger, longer R01-style project. These projects often prioritize proof-of-concept analyses, development of new epidemiologic approaches, or testing of innovative hypotheses that can justify larger follow-on studies. The listing also clearly states "Clinical Trial Not Allowed," which means proposals should not include prospective interventional studies where participants are assigned to receive a treatment or behavioral intervention to evaluate health outcomes. Observational epidemiologic research is the intended fit, including analyses of existing data or biospecimens, population-based observational designs, and other non-interventional human research approaches.

Eligibility is broad and includes many types of U.S. organizations and governmental units. Eligible applicants include state, county, city, township, and 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; tribal organizations that are not federally recognized governments; public housing authorities and Indian housing authorities; nonprofits with or without 501(c)(3) status (as long as they are not institutions of higher education); for-profit organizations other than small businesses; and small businesses. In addition, NIH explicitly notes several other eligible applicant categories, such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISISs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, eligible federal agencies, U.S. territories or possessions, regional organizations, and even non-U.S. entities (foreign organizations). This broad eligibility creates room for academic, public health, community, and cross-sector groups to propose studies that reflect diverse populations and real-world exposure contexts.

Key administrative details provided include an original closing date of 2025-05-07 and a creation date of 2024-10-10. The source information does not list an award ceiling or the expected number of awards, so applicants would typically confirm budget limits and award expectations by consulting the full FOA text and related NIH policy pages. Overall, the opportunity is best suited for teams with access to relevant population data or specimens and a strong epidemiologic plan to examine emerging liver cancer risk drivers in the U.S., especially studies that can clarify who is most susceptible and why, and that can lay groundwork for improved prevention, early detection strategies, or future larger-scale investigations.

  • The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "Epidemiologic Research on Emerging Risk Factors and Liver Cancer Susceptibility (R21 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): 93.393.
  • This funding opportunity was created on 2024-10-10.
  • Applicants must submit their applications by 2025-05-07. (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 PA 25 123

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Frequently Asked Questions (FAQs)

What is the title of this NIH funding opportunity?

The opportunity is titled "Epidemiologic Research on Emerging Risk Factors and Liver Cancer Susceptibility (R21 Clinical Trial Not Allowed)."

What is the Funding Opportunity Number (FON) for this announcement?

The Funding Opportunity Number is PA 25 123.

What CFDA number is associated with this opportunity?

The CFDA number listed is 93.393.

What is the main goal of this grant announcement?

The goal is to support early-stage, innovative epidemiologic studies that test new hypotheses about what is driving liver cancer risk in the United States, with an emphasis on emerging risk factors and how they may interact with well-established causes such as viral hepatitis.

What type of grant mechanism is being used?

This is an NIH R21 mechanism, which is the exploratory/developmental grant format designed to support novel, potentially high-impact projects that may be earlier in development than larger R01-style projects.

What does the R21 mechanism imply about the kinds of projects NIH is looking for?

It signals interest in exploratory, hypothesis-driven work such as proof-of-concept analyses, development of new epidemiologic approaches, or testing innovative hypotheses that could justify larger follow-on studies.

Are clinical trials allowed under this funding opportunity?

No. The announcement states "Clinical Trial Not Allowed," meaning proposals should not include prospective interventional studies where participants are assigned to receive a treatment or behavioral intervention to evaluate health outcomes.

If clinical trials are not allowed, what kind of human research is appropriate?

Observational epidemiologic research is the intended fit. Examples described include analyses of existing population-based data, cohorts, registries, biospecimens linked to health data, and other non-interventional human data resources.

What research area does this FOA focus on?

The focus is liver cancer broadly, including hepatocellular carcinoma and other histologic subtypes, with the aim of stimulating creative, hypothesis-driven epidemiologic research that can open new directions for prevention and risk stratification.

Does the opportunity focus only on hepatocellular carcinoma (HCC)?

No. The FOA covers liver cancer broadly, including hepatocellular carcinoma as well as other histologic subtypes.

What does NIH mean by "epidemiologic research" in this context?

It refers to studies that use population-based data and other human data resources to understand patterns, causes, and susceptibility. This can include cohorts, registries, biospecimens linked to health data, and similar observational resources.

What are "emerging risk factors" as described in the opportunity?

The announcement encourages research on emerging biological, environmental, and social risk factors, including newer or rapidly changing exposures such as shifts in metabolic health and obesity-related pathways, evolving environmental contaminants, changing patterns of medication or substance use, and social or structural determinants that influence exposure, diagnosis, and outcomes.

Is NIH encouraging studies on interactions between emerging and established risk factors?

Yes. A central theme is interplay, including how newer factors combine with established risks like chronic hepatitis B or C infection, potentially altering risk levels, changing disease trajectories, or creating distinct high-risk subgroups.

What established liver cancer risk factors are specifically mentioned?

The opportunity specifically mentions viral hepatitis, including chronic hepatitis B and chronic hepatitis C infection, as well-established causes that may interact with emerging risk factors.

What outcomes or longer-term impacts is this research expected to support?

The announcement emphasizes research that can clarify who is most susceptible and why, and that can lay groundwork for improved prevention, early detection strategies, risk stratification, and future larger-scale investigations.

Who is eligible to apply?

Eligibility is broad and includes many types of U.S. organizations and governmental units, as well as foreign organizations (non-U.S. entities) per the source information provided.

What types of U.S. government entities are eligible applicants?

Eligible applicants include state, county, city, township, and special district governments, as well as independent school districts.

Are higher education institutions eligible?

Yes. Public and state-controlled institutions of higher education and private institutions of higher education are eligible.

Are tribal entities eligible to apply?

Yes. Federally recognized Native American tribal governments are eligible, as are tribal organizations that are not federally recognized governments.

Are nonprofits eligible, and do they need 501(c)(3) status?

Nonprofits with or without 501(c)(3) status are eligible, as long as they are not institutions of higher education (as stated in the eligibility listing).

Are for-profit organizations eligible?

Yes. For-profit organizations other than small businesses are eligible, and small businesses are also listed as eligible.

Are housing authorities eligible applicants?

Yes. Public housing authorities and Indian housing authorities are included in the eligible applicant types.

Are faith-based or community-based organizations eligible?

Yes. The announcement explicitly notes faith-based or community-based organizations as eligible applicant categories.

Are minority-serving institutions mentioned as eligible?

Yes. The eligibility list includes Alaska Native and Native Hawaiian Serving Institutions, AANAPISISs, Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), and Tribally Controlled Colleges and Universities (TCCUs).

Are federal agencies eligible to apply?

Yes. Eligible federal agencies are explicitly noted as an eligible applicant category.

Are U.S. territories or possessions eligible?

Yes. U.S. territories or possessions are included among eligible applicant categories.

Are regional organizations eligible?

Yes. Regional organizations are listed as eligible.

Are non-U.S. (foreign) organizations eligible?

Yes. The eligibility information provided indicates that non-U.S. entities (foreign organizations) are eligible.

What is the application due date mentioned in the provided information?

The original closing date listed is 2025-05-07.

What is the creation date listed for this opportunity?

The creation date listed is 2024-10-10.

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

No. The source information does not list an award ceiling or the expected number of awards.

What kinds of data resources are highlighted as a good fit for this opportunity?

The announcement points to population-based data, cohorts, registries, and biospecimens linked to health data, along with other human data resources that support observational epidemiologic research.

Is this opportunity oriented toward U.S. liver cancer risk specifically?

Yes. The stated goal emphasizes understanding what is driving liver cancer risk in the United States.

What kinds of research teams are best positioned for this opportunity based on the description?

Teams with access to relevant population data or biospecimens and a strong epidemiologic plan to examine emerging liver cancer risk drivers in the U.S., particularly studies that clarify susceptibility and can inform prevention or early detection, appear best aligned with the stated aims.

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