Opportunity Information: Apply for PAR 19 292
The NIH funding opportunity PAR 19-292, titled "Mechanistic Studies of Gene-Environment Interplay in Dental, Oral, Craniofacial, and Other Diseases and Conditions (R01 Clinical Trial Not Allowed)," supports hypothesis-driven research aimed at explaining how genetic variation and environmental exposures work together to influence disease. The central emphasis is on biological mechanism: applicants are expected to move beyond identifying associations and instead clarify the causal pathways, molecular events, and gene or gene-network behaviors that change when specific environmental factors are present. The participating NIH institutes highlighted here are the National Institute of Dental and Craniofacial Research (NIDCR) and the National Institute of Environmental Health Sciences (NIEHS), reflecting a cross-cutting interest in oral and craniofacial health as well as broader environmental determinants of health.
This program is designed for mechanistic studies conducted using animal models, in vitro systems (such as cell culture models, organoids, or engineered tissues), or ex vivo approaches (for example, experiments performed on tissues collected from organisms and studied outside the body). The goal is to understand gene-environment interplay in conditions affecting the dental, oral, and craniofacial complex, while also allowing relevance to other diseases and conditions where oral or craniofacial biology, environmental exposures, or shared pathways are important. In practical terms, strong applications typically focus on clearly defined environmental factors (such as chemicals, pollutants, diet-related exposures, microbiome shifts, tobacco-related exposures, stressors, or other measurable environmental influences) and well-characterized genetic factors (specific genes, variants, regulatory elements, or gene networks), then use experimental designs that can directly test mechanistic links between them.
The activity mechanism is the NIH R01 research project grant, and the announcement explicitly states that clinical trials are not allowed under this FOA. That means the proposed work should not be designed as a prospective human intervention study intended to evaluate health outcomes. While human-derived materials may be used in ex vivo contexts and human data may be used to inform mechanistic hypotheses, the funded research must remain outside the NIH definition of a clinical trial. The opportunity is categorized as discretionary funding and falls under CFDA numbers 93.113, 93.121, and 93.865, which correspond to relevant NIH assistance listings.
Eligibility is broad and includes many common U.S. applicant types: state, county, city or township 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; tribal organizations that are not federally recognized; public housing authorities and Indian housing authorities; nonprofits with and without 501(c)(3) status (excluding institutions of higher education when applicable); for-profit organizations other than small businesses; small businesses; and other eligible entities. The FOA also explicitly calls out additional eligible applicants 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, and U.S. territories or possessions.
For international participation, the rules are specific. Non-domestic (non-U.S.) entities and foreign institutions are not eligible to apply as the primary applicant organization. However, non-domestic components of U.S. organizations are eligible, and foreign components, as defined by the NIH Grants Policy Statement, are allowed. In other words, a U.S.-based applicant can include certain international elements in the project when scientifically justified and consistent with NIH policy, but a foreign institution cannot be the lead applicant.
The posting lists an original closing date of 2022-09-07 and a creation date of 2019-06-05. No award ceiling or expected number of awards is specified in the provided source data, which is common for NIH FOAs where budgets are generally governed by the scope of work, NIH policy constraints, and institute-specific considerations rather than a single fixed cap. Overall, the opportunity is best understood as a mechanism-focused R01 aimed at experimentally unpacking how environmental exposures interact with genetic architecture to drive disease-related biology, with a particular focus on dental, oral, and craniofacial conditions and strong alignment with NIDCR and NIEHS scientific priorities.Apply for PAR 19 292
- The National Institutes of Health in the environment, health, income security and social services sector is offering a public funding opportunity titled "Mechanistic Studies of Gene-Environment Interplay in Dental, Oral, Craniofacial, and Other Diseases and Conditions (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): 93.113, 93.121, 93.865.
- This funding opportunity was created on 2019-06-05.
- Applicants must submit their applications by 2022-09-07. (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.
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FAQs: NIH PAR 19-292 (R01 Clinical Trial Not Allowed)
What is PAR 19-292?
PAR 19-292 is an NIH funding opportunity titled "Mechanistic Studies of Gene-Environment Interplay in Dental, Oral, Craniofacial, and Other Diseases and Conditions (R01 Clinical Trial Not Allowed)." It supports hypothesis-driven research that explains how genetic variation and environmental exposures work together to influence disease, with a strong emphasis on biological mechanism rather than simple association.
What is the main scientific focus of this opportunity?
The central focus is mechanistic gene-environment interplay. Applications are expected to move beyond identifying correlations and instead clarify causal pathways, molecular events, and gene or gene-network behaviors that change when specific environmental factors are present.
Which NIH institutes are participating (as highlighted here)?
The participating NIH institutes highlighted are the National Institute of Dental and Craniofacial Research (NIDCR) and the National Institute of Environmental Health Sciences (NIEHS), reflecting interests spanning oral and craniofacial health and broader environmental determinants of health.
What funding mechanism does PAR 19-292 use?
This opportunity uses the NIH R01 research project grant mechanism.
Are clinical trials allowed under this FOA?
No. The announcement explicitly states "Clinical Trial Not Allowed." The proposed work should not be designed as a prospective human intervention study intended to evaluate health outcomes under the NIH definition of a clinical trial.
If clinical trials are not allowed, what kinds of studies are appropriate?
Mechanistic studies conducted using animal models, in vitro systems (such as cell culture models, organoids, or engineered tissues), or ex vivo approaches (experiments performed on tissues collected from organisms and studied outside the body) are specifically described as appropriate for this program.
Can the research relate to diseases beyond dental, oral, and craniofacial conditions?
Yes. While the goal is to understand gene-environment interplay in conditions affecting the dental, oral, and craniofacial complex, the FOA also allows relevance to other diseases and conditions where oral or craniofacial biology, environmental exposures, or shared pathways are important.
What does "mechanistic" mean in the context of this FOA?
"Mechanistic" means the study is designed to experimentally unpack how and why an environmental exposure and a genetic factor interact to drive disease-related biology. The expectation is to identify causal pathways, molecular events, and changes in gene or gene-network behavior when an exposure is present, rather than stopping at an association.
What are examples of environmental factors that fit this FOA?
The FOA describes clearly defined environmental factors such as chemicals, pollutants, diet-related exposures, microbiome shifts, tobacco-related exposures, stressors, or other measurable environmental influences.
What are examples of genetic factors that fit this FOA?
The FOA describes well-characterized genetic factors such as specific genes, variants, regulatory elements, or gene networks.
What types of experimental designs are encouraged?
Experimental designs that can directly test mechanistic links between defined environmental factors and defined genetic factors are emphasized. The key idea is to enable causal inference about the biological mechanism of the interaction.
Can human materials or human data be used at all?
Yes, with constraints. The FOA indicates that human-derived materials may be used in ex vivo contexts and human data may be used to inform mechanistic hypotheses, but the funded research must remain outside the NIH definition of a clinical trial.
What does "R01 Clinical Trial Not Allowed" imply for the project scope?
It implies the project should not be structured as a prospective human intervention evaluating outcomes. Instead, it should remain focused on mechanistic biology using animal, in vitro, and/or ex vivo approaches, even if human-derived tissues or human data help shape or support mechanistic hypotheses.
What is the funding category for this opportunity?
The opportunity is categorized as discretionary funding.
What are the CFDA (assistance listing) numbers associated with this FOA?
The FOA is listed under CFDA numbers 93.113, 93.121, and 93.865.
Who is eligible to apply?
Eligibility is broad and includes: state, county, city or township 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; tribal organizations that are not federally recognized; public housing authorities and Indian housing authorities; nonprofits with and without 501(c)(3) status (excluding institutions of higher education when applicable); for-profit organizations other than small businesses; small businesses; and other eligible entities.
Are specific institution types explicitly called out as eligible?
Yes. The FOA explicitly calls out 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, and U.S. territories or possessions.
Can a foreign (non-U.S.) institution apply as the primary applicant?
No. Non-domestic (non-U.S.) entities and foreign institutions are not eligible to apply as the primary applicant organization under this FOA.
Is any international participation allowed?
Yes. Non-domestic components of U.S. organizations are eligible, and foreign components (as defined by the NIH Grants Policy Statement) are allowed. A U.S.-based applicant can include certain international elements when scientifically justified and consistent with NIH policy.
What is the original closing date listed for this opportunity?
The posting lists an original closing date of 2022-09-07.
What is the creation date listed for this opportunity?
The creation date listed is 2019-06-05.
Is there an award ceiling or a specified number of expected awards?
No. The provided source data does not specify an award ceiling or an expected number of awards. This can be common for NIH FOAs where budgets are generally governed by scope of work, NIH policy constraints, and institute-specific considerations rather than a single fixed cap.
What kinds of applications are likely to be strong for this FOA?
Based on the description, strong applications typically: (1) define specific, measurable environmental exposures; (2) specify well-characterized genetic factors (genes, variants, regulatory elements, or networks); and (3) use mechanistic experimental approaches (animal, in vitro, or ex vivo) that can directly test causal links between the exposure and the genetic architecture in disease-relevant biology.
What is the overall purpose of PAR 19-292 in plain terms?
Its purpose is to fund R01 projects that experimentally explain how environmental exposures and genetic variation interact to drive disease-related biological changes, with particular focus on dental, oral, and craniofacial conditions and alignment with NIDCR and NIEHS priorities.
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| Development of Novel and Robust Systems for Mechanistic Studies of Gene-Environment Interplay in Dental, Oral, Craniofacial, and Other Diseases and Conditions (R21 Clinical Trial Not Allowed) Apply for PAR 19 293 Funding Number: PAR 19 293 Agency: National Institutes of Health Category: Environment, Health, Income Security and Social Services Funding Amount: $200,000 |
| Small Research Grants for Establishing Basic Science-Clinical Collaborations to Understand Structural Birth Defects (R03 Clinical Trial Not Allowed) Apply for PAR 20 065 Funding Number: PAR 20 065 Agency: National Institutes of Health Category: Environment, Health, Income Security and Social Services Funding Amount: $75,000 |
| Small Research Grants for Analyses of Down Syndrome-related Research Data for the INCLUDE Project (R03 Clinical Trial Not Allowed) Apply for RFA OD 20 006 Funding Number: RFA OD 20 006 Agency: National Institutes of Health Category: Environment, Health, Income Security and Social Services Funding Amount: Case Dependent |
| Transformative Research Award for the INCLUDE (Investigation of Co-occurring Conditions across the Lifespan to Understand Down syndrome) Project (R01 Clinical Trial Not Allowed) Apply for RFA OD 20 005 Funding Number: RFA OD 20 005 Agency: National Institutes of Health Category: Environment, Health, Income Security and Social Services Funding Amount: Case Dependent |
| Research on Autism Spectrum Disorders (R01 Clinical Trial Optional) Apply for PA 21 201 Funding Number: PA 21 201 Agency: National Institutes of Health Category: Environment, Health, Income Security and Social Services Funding Amount: Case Dependent |
| Research on Autism Spectrum Disorders (R21 Clinical Trial Optional) Apply for PA 21 200 Funding Number: PA 21 200 Agency: National Institutes of Health Category: Environment, Health, Income Security and Social Services Funding Amount: $200,000 |
| Research on Autism Spectrum Disorders (R03 Clinical Trial Optional) Apply for PA 21 199 Funding Number: PA 21 199 Agency: National Institutes of Health Category: Environment, Health, Income Security and Social Services Funding Amount: $50,000 |
| Autism Centers of Excellence: Centers (P50 Clinical Trial Optional) Apply for RFA HD 22 008 Funding Number: RFA HD 22 008 Agency: National Institutes of Health Category: Environment, Health, Income Security and Social Services Funding Amount: $1,500,000 |
| Autism Centers of Excellence: Networks (R01 Clinical Trial Optional) Apply for RFA HD 22 007 Funding Number: RFA HD 22 007 Agency: National Institutes of Health Category: Environment, Health, Income Security and Social Services Funding Amount: $1,500,000 |
| Global Brain and Nervous System Disorders Research Across the Lifespan (R21 Clinical Trial Optional) Apply for PAR 21 319 Funding Number: PAR 21 319 Agency: National Institutes of Health Category: Environment, Health, Income Security and Social Services Funding Amount: Case Dependent |
| Global Brain and Nervous System Disorders Research Across the Lifespan (R01 Clinical Trials Optional) Apply for PAR 21 311 Funding Number: PAR 21 311 Agency: National Institutes of Health Category: Environment, Health, Income Security and Social Services Funding Amount: Case Dependent |
| Global Brain and Nervous System Disorders Research Across the Lifespan (R21 Clinical Trial Optional) Apply for PAR 22 098 Funding Number: PAR 22 098 Agency: National Institutes of Health Category: Environment, Health, Income Security and Social Services Funding Amount: Case Dependent |
| Global Brain and Nervous System Disorders Research Across the Lifespan (R01 Clinical Trials Optional) Apply for PAR 22 097 Funding Number: PAR 22 097 Agency: National Institutes of Health Category: Environment, Health, Income Security and Social Services Funding Amount: Case Dependent |
| Diagnostic Centers of Excellence (X01 Clinical Trial Not Allowed) Apply for PAR 23 171 Funding Number: PAR 23 171 Agency: National Institutes of Health Category: Environment, Health, Income Security and Social Services Funding Amount: Case Dependent |
| Implementation Research on Noncommunicable Disease Risk Factors among Low- and Middle-Income Country and Tribal Populations Living in City Environments (R01 Clinical Trial Optional) Apply for PAR 23 319 Funding Number: PAR 23 319 Agency: National Institutes of Health Category: Environment, Health, Income Security and Social Services Funding Amount: Case Dependent |
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