Opportunity Information: Apply for PAR 19 369

The National Institutes of Health (NIH) funding opportunity PAR-19-369, titled "Development of Animal Models and Related Biological Materials for Research (R21 Clinical Trial Not Allowed)," supports early-stage, innovative projects that strengthen the research infrastructure needed to study human health and disease. It is designed for exploratory, high-impact work under the R21 mechanism, with the goal of creating, improving, or rigorously characterizing animal models and related biological materials that can be broadly useful to the biomedical research community. The announcement also invites novel technologies that enhance how these models are built, validated, or applied, as long as the work remains preclinical and does not propose a clinical trial.

A central requirement of this FOA is that proposed projects must have broad relevance across multiple NIH Institutes or Centers, reflecting the trans-NIH mission of the Office of Research Infrastructure Programs (ORIP). In practical terms, this means the model, material, or enabling technology should not be narrowly tailored to a single disease area, a single organ system, or the priorities of only one NIH Institute or Center. The studies are expected to either explore multiple body systems or address diseases that affect multiple body systems, which helps ensure the outcomes can be leveraged by diverse research fields. Applications that focus on one specific disease or a single research niche, or that are primarily aligned with only one NIH Institute or Center, are considered non-responsive and will not be accepted under this announcement.

The scientific scope includes three main themes. First, it encourages development and refinement of animal models that better mirror complex human biology and disease processes, including work that improves how well models predict human outcomes. Second, it supports efforts to generate or enhance biological materials tied to animal models, such as well-characterized strains, colonies, tissues, cell resources, or other standardized materials that improve reproducibility and accessibility for the wider community. Third, it seeks technological innovation, meaning new tools or approaches that improve model creation, monitoring, phenotyping, validation, or cross-system characterization. Separately, the FOA also highlights the need to improve the diagnosis and control of diseases that interfere with the use of animals in biomedical research, recognizing that uncontrolled animal diseases can undermine research quality, animal welfare, and study reproducibility. This can include better diagnostic methods, surveillance approaches, or disease control strategies that protect the integrity of animal-based research programs, again with an expectation of broad applicability.

Eligibility is expansive across U.S.-based organizations and includes state, county, and local governments; special districts; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; other tribal organizations; public housing authorities/Indian housing authorities; nonprofits (both 501(c)(3) and non-501(c)(3)); for-profit organizations other than small businesses; and small businesses. The FOA also explicitly highlights additional eligible applicant types such as historically Black colleges and universities (HBCUs), Hispanic-serving institutions, tribally controlled colleges and universities (TCCUs), Alaska Native and Native Hawaiian-serving institutions, and Asian American, Native American, and Pacific Islander-serving institutions (AANAPISISs), as well as faith-based or community-based organizations, eligible federal agencies, regional organizations, and U.S. territories or possessions. Foreign institutions and non-U.S. components of U.S. organizations are not eligible to apply; however, foreign components may be included when allowed under NIH policy, meaning a primarily U.S.-led project can incorporate certain international elements if they meet NIH requirements.

The opportunity is categorized as a discretionary grant within the health funding activity area and is listed under CFDA 93.351. The award ceiling shown in the source information is $200,000. The original closing date provided is 2021-03-17, and the FOA was created on 2019-09-09. Overall, the program is aimed at producing broadly enabling, cross-cutting animal models, resources, and methods that can be used by many fields across NIH, while avoiding narrowly focused, single-disease model proposals and excluding clinical trial activity.

  • The National Institutes of Health in the health sector is offering a public funding opportunity titled "Development of Animal Models and Related Biological Materials for Research (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): 93.351.
  • This funding opportunity was created on 2019-09-09.
  • Applicants must submit their applications by 2021-03-17. (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 $200,000.00 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-19-369 - Development of Animal Models and Related Biological Materials for Research (R21 Clinical Trial Not Allowed)

What is PAR-19-369?

PAR-19-369 is a National Institutes of Health (NIH) funding opportunity titled "Development of Animal Models and Related Biological Materials for Research (R21 Clinical Trial Not Allowed)." It supports early-stage, innovative projects that strengthen research infrastructure by creating, improving, or rigorously characterizing animal models and related biological materials for broad use in biomedical research.

What is the main goal of this funding opportunity?

The goal is to produce broadly enabling, cross-cutting animal models, standardized biological materials, and/or enabling technologies that can be leveraged across multiple research fields and multiple NIH Institutes or Centers, improving the ability to study human health and disease in preclinical settings.

What grant mechanism does this FOA use?

This opportunity uses the NIH R21 mechanism, which is intended for exploratory, early-stage, and potentially high-impact projects.

Are clinical trials allowed under this FOA?

No. The FOA is explicitly labeled "Clinical Trial Not Allowed," and the supported work must remain preclinical and must not propose a clinical trial.

What types of projects are encouraged?

The FOA highlights three major areas: (1) development and refinement of animal models that better reflect complex human biology and disease processes and improve prediction of human outcomes, (2) generation or enhancement of biological materials tied to animal models (such as well-characterized strains, colonies, tissues, cell resources, or other standardized materials that improve reproducibility and accessibility), and (3) technological innovation that improves how models are created, monitored, phenotyped, validated, or characterized across systems.

What does "related biological materials" mean in this announcement?

Based on the information provided, related biological materials include resources associated with animal models such as well-characterized strains and colonies, tissues, cell resources, and other standardized materials intended to improve reproducibility and accessibility for the broader biomedical research community.

Does the FOA support technologies as well as animal models?

Yes. In addition to model development and biological materials, the FOA invites novel technologies that improve model construction, validation, monitoring, phenotyping, and cross-system characterization, as long as the project remains preclinical and has broad applicability.

What is the requirement for "broad relevance" across NIH?

A central requirement is that projects must have broad relevance across multiple NIH Institutes or Centers. The model, material, or enabling technology should not be narrowly tailored to a single disease area, a single organ system, or the priorities of only one NIH Institute or Center.

What kinds of applications are considered non-responsive?

Applications are considered non-responsive (and will not be accepted under this announcement) if they focus on one specific disease, a single research niche, or are primarily aligned with only one NIH Institute or Center rather than being broadly relevant across multiple NIH Institutes or Centers.

Does my project need to address multiple body systems?

The FOA indicates that studies are expected to either explore multiple body systems or address diseases that affect multiple body systems. This helps ensure that the outputs can be leveraged by diverse research fields.

How does the FOA address animal diseases that can interfere with research?

The FOA highlights the need to improve the diagnosis and control of diseases that interfere with the use of animals in biomedical research. It notes that uncontrolled animal diseases can undermine research quality, animal welfare, and reproducibility, and it supports broadly applicable approaches such as improved diagnostic methods, surveillance approaches, or disease control strategies.

Who is eligible to apply?

Eligibility includes a wide range of U.S.-based organizations, including state, county, and local governments; special districts; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; other tribal organizations; public housing authorities/Indian housing authorities; nonprofits (501(c)(3) and non-501(c)(3)); for-profit organizations other than small businesses; and small businesses.

Are minority-serving institutions and community-based organizations eligible?

Yes. The FOA explicitly highlights eligibility for organizations such as historically Black colleges and universities (HBCUs), Hispanic-serving institutions, tribally controlled colleges and universities (TCCUs), Alaska Native and Native Hawaiian-serving institutions, and Asian American, Native American, and Pacific Islander-serving institutions (AANAPISISs), as well as faith-based or community-based organizations.

Are federal agencies eligible to apply?

Yes. The FOA lists eligible federal agencies among the eligible applicant types.

Can U.S. territories apply?

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

Are foreign institutions eligible to apply?

No. Foreign institutions and non-U.S. components of U.S. organizations are not eligible to apply under this FOA.

Can a project include international (foreign) components?

Yes, foreign components may be included when allowed under NIH policy. This means a primarily U.S.-led project may incorporate certain international elements if they meet NIH requirements.

Which NIH office is associated with the trans-NIH infrastructure mission described here?

The FOA references the trans-NIH mission of the Office of Research Infrastructure Programs (ORIP) and ties the broad-relevance requirement to that mission.

What is the funding activity area and assistance listing identifier provided?

The opportunity is categorized as a discretionary grant within the health funding activity area and is listed under CFDA 93.351.

What is the award ceiling shown in the source information?

The award ceiling shown in the provided source information is $200,000.

What are the key dates provided for this opportunity?

The FOA was created on 2019-09-09, and the original closing date provided is 2021-03-17.

What makes a strong fit for this FOA based on the description?

Based on the description provided, a strong fit is an exploratory R21 project that creates, improves, or rigorously characterizes animal models, associated standardized biological materials, or enabling technologies that are broadly useful across multiple NIH Institutes or Centers, addresses multiple body systems or multi-system diseases, and stays entirely preclinical with no clinical trial component.

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