Physiomimetics and Organoids for Reproductive Health (R21 Clinical Trial Not Allowed) | RFA HD 23 025

Opportunity Information: Apply for RFA HD 23 025

The Physiomimetics and Organoids for Reproductive Health (R21 Clinical Trial Not Allowed) opportunity (RFA-HD-23-025) is a National Institutes of Health discretionary grant aimed at accelerating early-stage, exploratory research that builds better lab-based models of human reproduction. The central goal is to support the development of physiomimetic platforms and organoid culture systems that more closely mimic real reproductive tissues and environments, especially for studying the female reproductive tract and gametogenesis in both females and males. By improving these experimental systems, NIH is looking to enable researchers to identify biological, environmental, and mechanistic factors that contribute to gynecological diseases and infertility, areas where traditional 2D cell culture and many animal models often fall short.

This FOA specifically uses the R21 mechanism, which is designed for exploratory and developmental projects, meaning it is well-suited for ideas that are high-risk and high-reward and may not yet have extensive preliminary data. In practice, that makes it a good fit for teams proposing novel organoid methods, advanced tissue engineering approaches, microphysiological systems, organ-on-chip style platforms, new co-culture strategies, or other innovative tools that can recreate key physiological features of reproductive tissues. The announcement also signals a pathway for more mature projects: applicants who already have stronger preliminary evidence may be better positioned for the companion R01 funding opportunity (RFA-HD-23-024), which generally supports larger, more fully developed research programs.

A key limitation is stated directly in the title: clinical trials are not allowed under this R21. That means the work should remain in the preclinical, mechanistic, and model-development space, focusing on laboratory systems rather than interventional studies in human participants. Even though the scientific focus is closely tied to human health outcomes like infertility and gynecologic conditions, the supported activities are intended to be platform-building and discovery-oriented, not clinical testing.

The funding is categorized under Health, Income Security and Social Services and is listed under CFDA 93.865. The award ceiling is $275,000, reflecting the smaller, pilot-style nature typical of R21 awards. The original closing date listed for this particular notice is 2023-03-29, and the creation date is 2022-08-22, which helps place it in time and may matter for determining whether the opportunity is still active or whether a reissue or related announcement should be pursued.

Eligibility is broad and includes many organization types across the public, private, nonprofit, and educational sectors. Eligible applicants include state, county, city, 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; tribal organizations that are not federally recognized; 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 FOA also explicitly highlights additional eligible applicant categories such as Alaska Native and Native Hawaiian Serving Institutions, AANAPISI institutions, Hispanic-serving institutions, Historically Black Colleges and Universities, Tribally Controlled Colleges and Universities, faith-based or community-based organizations, eligible federal agencies, regional organizations, U.S. territories or possessions, and even non-U.S. entities (foreign organizations). Taken together, NIH is clearly encouraging a wide range of applicants and partnerships, including those that can bring specialized engineering, biomaterials, reproductive biology, or translational modeling expertise to the challenge.

Overall, this opportunity is best understood as NIH support for building next-generation reproductive biology models that behave more like real tissues, with the long-term intention of improving understanding of disease mechanisms and infertility drivers. It is positioned for innovative, early-stage research where the main deliverable is a more physiologically relevant platform or organoid system that can open doors to new experiments and insights, rather than a clinical study or a late-stage product validation effort.

• The National Institutes of Health in the health, income security and social services sector is offering a public funding opportunity titled "Physiomimetics and Organoids for Reproductive Health (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): 93.865.
• This funding opportunity was created on 2022-08-22.
• Applicants must submit their applications by 2023-03-29. (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 $275,000.00 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 RFA HD 23 025

[Watch] Creating a grant proposal using the step-by-step wizard inside the applicant portal: