Opportunity Information: Apply for PAR 19 138

ImmuneChip: Engineering Microphysiological Immune Tissue Platforms (U01 Clinical Trial Not Allowed) is a National Institutes of Health (NIH) cooperative agreement funding opportunity (PAR-19-138) aimed at accelerating the creation and improvement of lab-based, human-relevant immune system models. The core goal is to push beyond traditional 2-D cell culture and develop in vitro platforms that more realistically mimic key components and behaviors of the human immune system. The FOA is centered on building and validating microphysiological immune tissue platforms, meaning engineered 3-D tissue-like systems that can reproduce important immune functions in a controlled environment and make immune biology easier to study, measure, and translate.

The program emphasizes three main technical directions. First, it encourages engineering new 3-D in vitro immune tissues, which could include constructs that recreate immune-cell organization, trafficking, signaling, and functional responses that are difficult to capture in simpler models. Second, it supports adding immune responsiveness to existing in vitro platforms, which speaks to integrating immune components into organ-on-chip or tissue-chip systems so that immune interactions (such as inflammation, immune-mediated injury, or immune modulation) can be studied alongside the target tissue. Third, it invites in vitro modeling of autoimmune diseases and inflammation, focusing on platforms that can reproduce disease-relevant immune dysregulation and inflammatory pathways, potentially enabling better mechanistic studies and more predictive testing of interventions without relying on animal models or clinical trials.

This is a U01 mechanism, which is a cooperative agreement rather than a standard grant. In practical terms, that usually signals substantial programmatic involvement from NIH staff during the project period, often including coordinated milestones, shared standards, or collaboration across awardees. The FOA is explicitly labeled “Clinical Trial Not Allowed,” which means proposed work must remain preclinical and platform-focused, without testing interventions in human participants as a clinical trial. The activity category is health-related, with CFDA numbers listed as 93.286, 93.350, and 93.846, reflecting NIH program areas connected to advanced biomedical research infrastructure, immunology, and bioengineering-oriented efforts.

Eligibility is broad across U.S.-based organizations and includes state, county, city or township governments; special district governments; independent school districts; public housing authorities/Indian housing authorities; public and state-controlled institutions of higher education; private institutions of higher education; nonprofits (both 501(c)(3) and non-501(c)(3), excluding higher education when specified); for-profit organizations (other than small businesses); and small businesses. It also highlights a wide range of mission-driven and capacity-building institution types as “other eligible applicants,” including 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), eligible federal agencies, faith-based or community-based organizations, regional organizations, and U.S. territories or possessions. Federally recognized tribal governments are eligible, and tribal organizations other than federally recognized tribal governments are also listed among eligible applicant categories.

At the same time, the FOA draws clear boundaries around foreign involvement. Non-domestic (non-U.S.) entities (foreign institutions) 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. In other words, the work needs to be fully U.S.-based in terms of the applicant organization and project components, with no formal foreign components embedded in the funded project structure.

From an administrative standpoint, the opportunity was created on 2018-12-27 and had an original closing date of 2019-03-26. The listing does not provide an award ceiling or expected number of awards in the source data provided, so applicants would typically look to the full FOA text for budget expectations, project period norms, and any milestone-driven cooperative agreement requirements. Overall, the opportunity is best understood as a targeted NIH effort to build next-generation immune tissue and immune-integrated microphysiological systems that can model immune function, inflammation, and autoimmune mechanisms more faithfully in vitro, improving the tools available for biomedical discovery and preclinical evaluation while staying outside the scope of clinical trials.

  • The National Institutes of Health in the health sector is offering a public funding opportunity titled "ImmuneChip: Engineering Microphysiological Immune Tissue Platforms (U01 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): 93.286, 93.350, 93.846.
  • This funding opportunity was created on 2018-12-27.
  • Applicants must submit their applications by 2019-03-26. (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 19 138

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Frequently Asked Questions (FAQs)

What is the ImmuneChip funding opportunity (PAR-19-138)?

ImmuneChip: Engineering Microphysiological Immune Tissue Platforms (U01 Clinical Trial Not Allowed) is a National Institutes of Health (NIH) cooperative agreement funding opportunity (PAR-19-138) focused on accelerating the development and improvement of lab-based, human-relevant immune system models. The emphasis is on building and validating in vitro platforms that better mimic key components and behaviors of the human immune system than traditional 2-D cell culture.

What is the main goal of this FOA?

The core goal is to push beyond conventional 2-D cell culture by engineering and validating microphysiological immune tissue platforms: engineered 3-D, tissue-like systems that reproduce important immune functions in a controlled environment. These platforms are intended to make immune biology easier to study, measure, and translate in preclinical research settings.

What does "microphysiological immune tissue platform" mean in this context?

In this FOA, it refers to engineered 3-D in vitro systems designed to recreate key immune tissue features and functions. These may include immune-cell organization, trafficking, signaling, and functional responses that are hard to capture in simpler models.

What types of scientific or technical approaches does the program emphasize?

The FOA emphasizes three main technical directions: (1) engineering new 3-D in vitro immune tissues, (2) adding immune responsiveness to existing in vitro platforms (such as integrating immune components into organ-on-chip or tissue-chip systems), and (3) in vitro modeling of autoimmune diseases and inflammation.

Does the FOA support creating brand-new 3-D immune tissue models?

Yes. One of the primary directions is engineering new 3-D in vitro immune tissues, including constructs that can recreate immune-cell organization, immune-cell movement/trafficking, signaling, and functional immune responses.

Can existing organ-on-chip or tissue-chip systems be adapted under this FOA?

Yes. The FOA explicitly supports adding immune responsiveness to existing in vitro platforms, which includes integrating immune components into organ-on-chip or tissue-chip systems so immune interactions can be studied alongside the target tissue.

What kinds of immune interactions are relevant to "adding immune responsiveness"?

The description highlights studying immune interactions such as inflammation, immune-mediated injury, or immune modulation in combination with the target tissue, enabled by integrating immune system components into existing in vitro platforms.

Does the FOA include autoimmune disease and inflammation modeling?

Yes. A specific technical direction is in vitro modeling of autoimmune diseases and inflammation, with an emphasis on platforms that can reproduce disease-relevant immune dysregulation and inflammatory pathways.

Is this opportunity intended to replace animal models or reduce reliance on them?

The provided description indicates the platforms could enable more predictive testing and mechanistic studies without relying on animal models or clinical trials, by modeling immune function and dysregulation in vitro.

What funding mechanism is used (U01), and what does it imply?

This FOA uses the U01 mechanism, which is a cooperative agreement rather than a standard grant. Practically, that typically indicates substantial programmatic involvement by NIH staff during the project period, often through coordinated milestones, shared standards, or collaboration across awardees.

What does "Clinical Trial Not Allowed" mean for this FOA?

"Clinical Trial Not Allowed" means the proposed work must remain preclinical and platform-focused. The project cannot include testing interventions in human participants as a clinical trial.

Can applicants propose studies involving human participants?

Based on the "Clinical Trial Not Allowed" label, the FOA does not allow projects that involve testing interventions in human participants as a clinical trial. The opportunity is described as preclinical and platform-focused.

Who is the sponsoring agency for this opportunity?

The sponsoring agency is the National Institutes of Health (NIH).

What is the activity category or general area of research?

The activity category is health-related and focused on immunology and bioengineering-oriented efforts tied to advanced biomedical research platforms and infrastructure.

What CFDA numbers are associated with this FOA?

The CFDA numbers listed are 93.286, 93.350, and 93.846.

What organizations are eligible to apply?

Eligibility is broad across U.S.-based organizations and includes state, county, city or township governments; special district governments; independent school districts; public housing authorities/Indian housing authorities; public and state-controlled institutions of higher education; private institutions of higher education; nonprofits (both 501(c)(3) and non-501(c)(3), excluding higher education when specified); for-profit organizations (other than small businesses); and small businesses.

Are small businesses eligible?

Yes. Small businesses are explicitly listed as eligible applicants.

Are for-profit organizations eligible?

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

Are universities and colleges eligible?

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

Are nonprofits eligible to apply?

Yes. Nonprofits with 501(c)(3) IRS status and nonprofits without 501(c)(3) IRS status are included among eligible applicants (with the note that higher education is treated separately when specified).

Are state and local governments eligible?

Yes. State governments, county governments, city or township governments, special district governments, and independent school districts are included among eligible applicants.

Are tribal governments and tribal organizations eligible?

Yes. Federally recognized tribal governments are eligible, and tribal organizations other than federally recognized tribal governments are also listed among eligible applicant categories.

Are U.S. territories or possessions eligible?

Yes. U.S. territories or possessions are included among the listed "other eligible applicants."

Are minority-serving institutions and specific institution types highlighted as eligible?

Yes. The FOA highlights a wide range of mission-driven and capacity-building institution types as eligible, including 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), and Tribally Controlled Colleges and Universities (TCCUs).

Are faith-based or community-based organizations eligible?

Yes. Faith-based or community-based organizations are listed among eligible applicant categories.

Are federal agencies eligible to apply?

Yes. Eligible federal agencies are listed among eligible applicants.

Are foreign (non-U.S.) institutions eligible to apply?

No. Non-domestic (non-U.S.) entities (foreign institutions) are not eligible to apply under this FOA.

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 NIH defines them in the NIH Grants Policy Statement) are not allowed. The project components must be fully U.S.-based.

Are "foreign components" allowed in any form?

No. The FOA states that foreign components (as defined by NIH policy) are not allowed.

When was this funding opportunity created?

The opportunity was created on 2018-12-27.

What was the original closing date?

The original closing date listed is 2019-03-26.

Does the listing provide an award ceiling or the expected number of awards?

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

Where would applicants typically find budget expectations and project period norms?

Because the listing does not provide an award ceiling or expected number of awards, applicants would typically consult the full FOA text for budget expectations, typical project periods, and any milestone-driven cooperative agreement requirements.

What kind of work is this FOA best suited for?

Based on the description, it is best suited for preclinical, in vitro platform development and validation efforts that create next-generation immune tissue models, integrate immune functionality into existing microphysiological systems, or model inflammation and autoimmune mechanisms in controlled, human-relevant engineered systems.

Is the focus more on platform development than on testing treatments in people?

Yes. The FOA is platform-centered and preclinical, and it is explicitly labeled "Clinical Trial Not Allowed," meaning it is not intended for clinical testing in human participants.

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