Physiomimetics and Organoids for Reproductive Health (R01 Clinical Trial Not Allowed) | RFA HD 23 024

Opportunity Information: Apply for RFA HD 23 024

The National Institutes of Health (NIH) funding opportunity titled "Physiomimetics and Organoids for Reproductive Health (R01 Clinical Trial Not Allowed)" (Funding Opportunity Number: RFA-HD-23-024; CFDA: 93.865) supports research projects focused on building and improving advanced lab models of human reproductive biology. The core aim is to develop physiomimetic platforms (systems that mimic key physical and biological conditions found in the body, such as fluid flow, mechanical forces, tissue-tissue interfaces, and microenvironmental cues) and organoid culture systems (3D, self-organizing, tissue-like cell models) that can be used to study the female reproductive tract as well as gametogenesis in both females and males. These engineered or organoid-based systems are intended to help researchers uncover biological, environmental, or mechanistic factors that contribute to gynecologic disorders and infertility, ultimately enabling more realistic and informative preclinical research than traditional 2D cell culture or some animal models.

This is an R01 mechanism, which generally indicates NIH is looking for well-developed, hypothesis-driven projects with a clear plan, strong rigor, and enough supporting evidence to justify a larger, multi-year effort. The announcement specifically notes that it is designed to advance projects where preliminary data already supports feasibility. In other words, applicants are expected to show that their approach is workable and that early results suggest the platform can be built and used as proposed. For groups that do not yet have preliminary data, NIH points to a companion, earlier-stage R21 opportunity (RFA-HD-23-025) that is more appropriate for exploratory or high-risk development work.

The scientific scope emphasizes tool and model development that is directly relevant to reproductive health research. On the female side, this includes models of the reproductive tract (such as uterus, endometrium, cervix, fallopian tube, ovary, and related interfaces) that can better represent human physiology and disease processes. On the gametogenesis side, the FOA covers both male and female gamete development, signaling interest in model systems that capture the cellular differentiation, maturation pathways, and microenvironmental requirements that underlie fertility. The emphasis on physiomimetics suggests NIH is especially interested in models that incorporate features like dynamic culture conditions, biomaterials or scaffolds that replicate tissue architecture, co-culture of multiple relevant cell types, and controlled biochemical gradients or hormonal cycling that more accurately reflect the in vivo reproductive milieu. These kinds of systems can be positioned to study mechanisms behind conditions such as endometriosis, uterine fibroids, polycystic ovary syndrome, implantation failure, pregnancy-related complications tied to early reproductive tract function, and idiopathic infertility, among others.

The FOA is explicitly labeled "Clinical Trial Not Allowed," which means applications should not propose clinical trials as part of the funded work. The expected work is preclinical and mechanistic, centered on building and validating platforms and then using them to investigate disease- or infertility-relevant biology. Validation and benchmarking are typically important in these model-building efforts, so competitive projects would be expected to define how the platform will be characterized for reproducibility, physiological relevance, and suitability for the intended research questions, while staying within the non-clinical-trial boundary.

Eligibility is broad and includes many types of domestic U.S. organizations and certain non-U.S. entities. Eligible applicants listed 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; other tribal organizations; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status (excluding institutions of higher education in those nonprofit categories); for-profit organizations other than small businesses; small businesses; and other organizations. The FOA also highlights additional eligible groups such as Alaska Native and Native Hawaiian Serving Institutions, AANAPISIs, Hispanic-serving institutions, Historically Black Colleges and Universities, Tribally Controlled Colleges and Universities, faith-based or community-based organizations, eligible federal agencies, regional organizations, tribal governments that are not federally recognized, U.S. territories or possessions, and non-domestic (foreign) organizations. This breadth signals NIH interest in drawing innovation from a wide range of research environments, including institutions serving underrepresented communities and international groups with specialized expertise in organoids, bioengineering, or reproductive biology.

Administratively, this is a discretionary grant opportunity under NIH, categorized under Health, Income Security and Social Services, using the grant funding instrument. The original closing date provided is March 29, 2023, and the FOA creation date is August 22, 2022. The provided summary does not include an award ceiling or the number of expected awards, so applicants would normally consult the full FOA text for budget guidance, project period limits, and review considerations. Overall, the opportunity is best understood as NIH support for maturing promising, feasibility-supported organoid and physiomimetic reproductive system models into robust platforms that the broader reproductive health field can use to better understand and eventually address gynecologic disease and infertility.

• 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 (R01 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.)
• 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 23 024

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