Opportunity Information: Apply for PAR 19 347
The National Institutes of Health (NIH) funding opportunity titled "Investigations on Primary Immunodeficiency Diseases/Inborn Errors of Immunity (R03 Clinical Trial Not Allowed)" (Funding Opportunity Number PAR-19-347) is a discretionary grant program designed to support small, focused research projects that advance knowledge of primary immunodeficiency diseases (PIDs), also commonly referred to as inborn errors of immunity (IEI). The central aim is to encourage studies that discover new immunodeficiency disorders and better characterize known ones, with an emphasis on understanding underlying causes and disease mechanisms. The FOA is oriented toward generating insights that can improve early detection, strengthen molecular diagnosis, and ultimately contribute to strategies that treat and, over time, potentially cure these disorders. Because this mechanism is an NIH R03, it is typically well-suited for pilot studies, feasibility work, early-stage hypothesis testing, or targeted projects that can produce clear, discrete outcomes without requiring the scale of a larger multi-year research award.
Scientifically, the opportunity prioritizes research that clarifies why and how these immune disorders occur and progress. Projects might focus on identifying genetic contributors, mapping how specific variants disrupt immune pathways, describing immune cell dysfunction in detail, or linking molecular abnormalities to clinical features. A major theme is translation-enabling knowledge: improving the ability to recognize these conditions earlier, refining diagnostic approaches through molecular and immunologic characterization, and building foundations for rational therapeutic strategies. While the FOA language highlights eventual treatment and cure as long-term goals, the supported work under this mechanism is primarily discovery and characterization oriented, meaning applicants are expected to produce data or mechanistic understanding that can be leveraged later for therapeutic development rather than running clinical interventions themselves.
A key boundary is spelled out in the title: clinical trials are not allowed. In practice, that means applicants cannot propose prospective studies in which human participants are assigned to an intervention to evaluate health-related outcomes. Research involving human samples or observational human studies may be possible if they fit NIH definitions for non-trial human subjects research, but anything that meets the NIH definition of a clinical trial would be out of scope for this FOA. Applicants typically need to be careful in how they design and describe human-related aims to avoid inadvertently proposing a trial-like structure.
From an eligibility standpoint, the FOA is broadly open across the U.S. research ecosystem. Eligible applicants include a wide range of public entities (state, county, city or township governments; special district governments; and certain public housing authorities), educational organizations (independent school districts, public and state-controlled institutions of higher education, and private institutions of higher education), tribal entities (federally recognized Native American tribal governments and other Native American tribal organizations), and nonprofit organizations (both 501(c)(3) and non-501(c)(3) nonprofits, as long as they are not institutions of higher education). For-profit organizations (other than small businesses) and small businesses are also listed as eligible, along with an "Other" category that NIH sometimes uses to accommodate additional applicant types consistent with federal policy. The FOA also explicitly calls out additional categories of eligible applicants, including Hispanic-serving institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), as well as faith-based or community-based organizations, eligible federal agencies, regional organizations, and U.S. territories or possessions.
At the same time, the FOA places firm limits on foreign involvement. Non-domestic (non-U.S.) entities and non-domestic (non-U.S.) institutions are not eligible to apply, and non-domestic components of U.S. organizations are also not eligible. In addition, foreign components, as NIH defines them in the NIH Grants Policy Statement, are not allowed under this announcement. In practical terms, this means the applicant organization must be domestic, the work cannot be carried out through a foreign component arrangement, and the project should not rely on a formal foreign component to conduct significant elements of the research.
Administratively, the opportunity is a grant (Funding Instrument Type: Grant) within the health research activity category, associated with CFDA number 93.855. The source information lists an award ceiling of $50,000, reflecting the small grant nature of the R03 mechanism, which is typically intended to support narrowly scoped, time-limited research aims. The announcement was created on 2019-08-16, with an original closing date listed as 2021-03-23. Even when a specific closing date is provided in a summary like this, NIH opportunities sometimes run on recurring receipt dates or may be reissued or expired, so applicants generally need to confirm the current status and applicable receipt dates in the live NIH posting and associated application instructions.
Overall, this FOA is best viewed as an NIH small-grant pathway for researchers who want to generate focused, high-value data on inborn errors of immunity: finding new disease entities, explaining mechanisms, improving diagnostic precision, and laying practical groundwork for better clinical management and future therapeutic advances, all while staying clearly on the non-clinical-trial side of NIH policy and keeping the project fully domestic in terms of applicant eligibility and project components.Apply for PAR 19 347
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Investigations on Primary Immunodeficiency Diseases/Inborn Errors of Immunity (R03 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): 93.855.
- This funding opportunity was created on 2019-08-16.
- Applicants must submit their applications by 2021-03-23. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Each selected applicant is eligible to receive up to $50,000.00 in funding.
- 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-19-347 (R03) - Investigations on Primary Immunodeficiency Diseases/Inborn Errors of Immunity (Clinical Trial Not Allowed)
What is the funding opportunity PAR-19-347 about?
PAR-19-347 is a National Institutes of Health (NIH) discretionary grant opportunity that supports small, focused research projects on primary immunodeficiency diseases (PIDs), also known as inborn errors of immunity (IEI). The program emphasizes discovery and characterization research that advances understanding of causes and mechanisms, helps improve early detection and molecular diagnosis, and lays groundwork for better treatments over time.
What type of NIH award mechanism is this?
This opportunity uses the NIH R03 mechanism, which is designed for small grants. It is generally well-suited for pilot projects, feasibility studies, early-stage hypothesis testing, and tightly scoped projects that can deliver clear, discrete outcomes without the scale of larger multi-year awards.
What is the central scientific aim of the FOA?
The central aim is to encourage studies that discover new immunodeficiency disorders and better characterize known ones, with an emphasis on understanding underlying causes and disease mechanisms. The FOA prioritizes research that clarifies why and how these immune disorders occur and progress.
What kinds of research topics does NIH prioritize under this announcement?
Priority areas include identifying genetic contributors, mapping how specific variants disrupt immune pathways, describing immune cell dysfunction in detail, and linking molecular abnormalities to clinical features. A major theme is producing translation-enabling knowledge that improves recognition and diagnosis and supports rational future therapeutic strategies.
Is the focus more on discovery/characterization or on treatment testing?
The supported work is primarily discovery and characterization oriented. While the long-term goals include improving treatment and ultimately contributing to potential cures, this R03 mechanism is positioned to generate mechanistic insights and focused data that can be leveraged in later-stage therapeutic development rather than running clinical interventions.
Are clinical trials allowed under PAR-19-347?
No. Clinical trials are not allowed. Applicants cannot propose prospective studies in which human participants are assigned to an intervention to evaluate health-related outcomes.
Can a project involve human participants or human samples if it is not a clinical trial?
The information provided indicates that research involving human samples or observational human studies may be possible if it fits NIH definitions for non-trial human subjects research. However, anything that meets the NIH definition of a clinical trial would be out of scope for this FOA. Applicants need to design and describe any human-related aims carefully to avoid a trial-like structure.
What is the main compliance risk when proposing human-related research?
The main risk is inadvertently proposing a study that NIH would define as a clinical trial. Because the FOA explicitly prohibits clinical trials, applicants typically must be careful that their design does not assign participants to an intervention to measure health-related outcomes.
Who is eligible to apply?
Eligibility is broad across U.S. organizations. Eligible applicants include public entities (state, county, city or township governments; special district governments; and certain public housing authorities), educational organizations (independent school districts; public and state-controlled institutions of higher education; and private institutions of higher education), tribal entities (federally recognized Native American tribal governments and other Native American tribal organizations), nonprofit organizations (both 501(c)(3) and non-501(c)(3) nonprofits that are not institutions of higher education), and for-profit organizations (including small businesses and other for-profits).
Are small businesses eligible to apply?
Yes. Small businesses are listed as eligible applicants under this opportunity.
Are for-profit organizations eligible to apply?
Yes. For-profit organizations (other than small businesses) are listed as eligible, and small businesses are also listed separately as eligible.
Are nonprofit organizations eligible to apply?
Yes. Both 501(c)(3) and non-501(c)(3) nonprofit organizations are eligible, as long as they are not institutions of higher education (as described in the eligibility summary provided).
Are institutions of higher education eligible?
Yes. Public and state-controlled institutions of higher education and private institutions of higher education are listed as eligible applicants.
Are tribal governments and tribal organizations eligible?
Yes. Federally recognized Native American tribal governments and other Native American tribal organizations are listed as eligible.
Are U.S. territories or possessions included in eligible applicant categories?
Yes. The FOA explicitly calls out U.S. territories or possessions among the additional categories of eligible applicants mentioned in the provided information.
Does the FOA encourage applications from specific institution types (e.g., HBCUs, HSIs)?
Yes. The FOA explicitly calls out several categories, including Hispanic-serving institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), and also mentions faith-based or community-based organizations, eligible federal agencies, and regional organizations.
Are foreign (non-U.S.) organizations allowed to apply?
No. Non-domestic (non-U.S.) entities and non-domestic institutions are not eligible to apply under this announcement.
Can a U.S. organization include a foreign component in the project?
No. The FOA states that 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, the applicant must be domestic and the work cannot be conducted through a foreign component arrangement.
What does it mean that "foreign components are not allowed" in practical terms?
Based on the provided summary, it means the applicant organization must be U.S.-based, the project cannot include a non-U.S. component of a U.S. organization, and the project should not rely on a formal foreign component to carry out significant elements of the research.
What is the funding instrument type?
The funding instrument type is a Grant.
What is the activity category or general area of support?
It is a health research opportunity associated with NIH and focused on immunodeficiency diseases/inborn errors of immunity.
What is the CFDA number associated with this opportunity?
The CFDA number listed is 93.855.
What is the award ceiling for this opportunity?
The source information lists an award ceiling of $50,000, consistent with the small-grant nature of an R03 mechanism and the expectation of a narrowly scoped, time-limited project.
When was this funding opportunity created and what closing date is shown?
The announcement was created on 2019-08-16, and the summary lists an original closing date of 2021-03-23.
Is the listed closing date necessarily the final word on when applications are due?
Not necessarily. The provided information notes that NIH opportunities sometimes use recurring receipt dates or may be reissued or expired. Applicants are advised to confirm the current status and applicable receipt dates in the live NIH posting and the associated application instructions.
What kinds of outcomes are most consistent with an R03 in this FOA?
Outcomes consistent with the R03 framing described include focused datasets, feasibility results, early mechanistic findings, variant-to-function insights, detailed immunologic characterization, or other discrete deliverables that strengthen molecular diagnosis and understanding of disease mechanisms, and that can support later, larger-scale studies.
What is the best overall way to think about this FOA?
It is best viewed as an NIH small-grant pathway to generate focused, high-value data on inborn errors of immunity: discovering new disease entities, explaining mechanisms, improving diagnostic precision, and laying practical groundwork for better clinical management and future therapeutic advances, while staying clearly outside clinical trial activities and keeping the project fully domestic.
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