Development of Animal Models and Related Biological Materials for Research (R21 Clinical Trial Not Allowed) | PAR 25 273

Opportunity Information: Apply for PAR 25 273

The National Institutes of Health (NIH), through a discretionary grant program administered under CFDA 93.351, is soliciting applications for PAR-25-273, titled "Development of Animal Models and Related Biological Materials for Research (R21 Clinical Trial Not Allowed)." This is an R21 exploratory/developmental opportunity, meaning it is designed to support innovative, early-stage, and potentially high-impact work that can open up new research directions rather than fund large, mature programs. Clinical trials are not allowed under this funding opportunity, so proposals need to stay firmly in the space of preclinical model development and related research infrastructure.

At its core, the program is looking for projects that create, improve, rigorously characterize, and preserve animal models that are broadly useful for biomedical research tied to human health and disease. That includes not only whole-animal models, but also animal-model-related biological materials and enabling technologies that make those models more valuable to the scientific community. The NOFO also explicitly encourages the development and use of new approach methodologies (NAMs), which generally refers to newer experimental approaches that may complement animal studies or improve how animal-related data are generated and interpreted, such as advanced in vitro systems, computational or data-driven methods, and other innovative methodologies that strengthen translational relevance or improve efficiency and reproducibility.

A second major emphasis is on work that improves the diagnosis, monitoring, prevention, or control of diseases that can confound biomedical research conducted in animal systems. In practice, this means proposals can target problems like infectious or endemic colony conditions, subclinical disease, or other health issues in research animals that might distort experimental outcomes, reduce reproducibility, or interfere with the humane and effective use of animal models. The intent is to strengthen the overall reliability and research utility of animal-based studies by reducing hidden variables and improving health management tools that support high-quality research.

A defining eligibility and review constraint is that the proposed project must have broad applicability across multiple NIH Institutes or Centers (ICs), aligning with the NIH-wide mission of the Office of Research Infrastructure Programs (ORIP). The announcement is explicit that applications are expected to be relevant to multiple body systems or multiple categories of diseases, and they must include animal models as part of the proposed studies. Proposals that are narrowly centered on a single disease area, a highly specific research niche, or that are primarily relevant to only one NIH IC are considered nonresponsive; the NOFO states such applications will be deemed not acceptable and withdrawn rather than simply scored poorly. In other words, program fit is not a minor detail here: the work needs to be framed and designed as generalizable infrastructure that enables many lines of NIH-supported research, not as a model built to answer one specific disease question.

The funding instrument is a grant, and the award ceiling is listed as $200,000. The opportunity’s original closing date is January 7, 2028, reflecting a multi-year window in which NIH expects to accept applications on the relevant due dates associated with the NOFO. While the expected number of awards is not specified in the provided source data, the R21 mechanism typically supports discrete, well-justified projects with a strong innovation component and a clear plan for how the resulting model, materials, or methods will be validated and made useful to the broader research community.

Eligibility is broad across U.S.-based organizations and governmental entities. 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; Native American tribal organizations that are not federally recognized tribal governments; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status (other than institutions of higher education); for-profit organizations other than small businesses; and small businesses. The NOFO also highlights additional categories 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 Pacific Islander Serving Institutions (AANAPISIs), as well as faith-based or community-based organizations and eligible federal agencies.

There are clear restrictions related to foreign involvement. Non-domestic (non-U.S.) entities (foreign organizations) are not eligible to apply, and non-domestic components of U.S. organizations are also not eligible. The listing also references U.S. territories or possessions and regional organizations among the “other eligible applicants” categories, but the central takeaway is that the applicant organization and the work proposed must remain within the eligibility boundaries that exclude foreign entities and foreign components.

Overall, this NOFO is best read as an NIH-wide research infrastructure call: it prioritizes broadly enabling animal models, associated biological resources, and methods that strengthen preclinical research across multiple disease areas and body systems, while also addressing animal health conditions that can undermine research outcomes. The most competitive applications will generally be those that clearly demonstrate wide relevance to multiple NIH IC missions, include credible plans for model or material development and characterization, and show how the outputs will improve rigor, reproducibility, and usefulness for a broad segment of the biomedical research community without drifting into a single-disease, single-institute scope.

• 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 2024-11-15.
• Applicants must submit their applications by 2028-01-07.
• 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.

Apply for PAR 25 273

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