Specialized Centers of Research Excellence (SCORE) on Sex Differences (U54 Clinical Trial Optional) | RFA OD 22 014

Opportunity Information: Apply for RFA OD 22 014

The NIH Office of Research on Women's Health (ORWH), together with participating NIH institutes and centers, is soliciting applications for the Specialized Centers of Research Excellence (SCORE) on Sex Differences under a U54 cooperative agreement mechanism (clinical trial optional). The purpose of this funding opportunity is to build and support Centers of Excellence that use interdisciplinary, team-based science to accelerate translational research on sex differences, meaning research that intentionally connects foundational biological mechanisms with clinical realities in ways that can ultimately improve prevention, diagnosis, and treatment. A central expectation is that each SCORE center will create a coherent, center-wide research agenda focused on a specific health issue where understanding sex differences is important, with an emphasis on improving the health of women. In practice, this means applicants should propose an integrated program that bridges basic and clinical research, rather than a collection of disconnected projects, and should be positioned to move discoveries along the pipeline from mechanisms to patient-relevant impact.

This opportunity uses the NIH cooperative agreement model, which generally indicates substantial scientific or programmatic involvement by NIH staff compared with a standard grant. While the listing does not provide an award ceiling or the expected number of awards in the provided text, the structure and intent suggest competitive center-level awards designed to support coordinated research efforts and shared infrastructure typical of a U54. The "clinical trial optional" designation means applicants may propose studies that include clinical trials if appropriate to their research plan, but clinical trials are not required; centers can be focused on translational work that may or may not include trial activity, depending on the scientific question and readiness for clinical evaluation.

A wide range of applicant organizations are eligible. The eligible applicant categories include many public-sector entities (such as state, county, city or township governments, special district governments, and independent school districts), federally recognized Native American tribal governments, and public housing authorities/Indian housing authorities. Academic eligibility includes public and state-controlled institutions of higher education as well as private institutions of higher education. Nonprofit organizations are eligible whether or not they have 501(c)(3) status, as long as they are not institutions of higher education. For-profit organizations (other than small businesses) and small businesses are also listed as eligible, along with an "other" category that can capture additional qualifying entities depending on NIH rules and the specific application setup.

The announcement also explicitly highlights additional eligible applicants, underscoring an interest in broad institutional participation and, often, capacity building across diverse settings. These include Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISI), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), and Tribally Controlled Colleges and Universities (TCCUs). It also references eligible federal agencies, faith-based or community-based organizations, regional organizations, Indian/Native American tribal governments other than federally recognized governments, and U.S. territories or possessions. This breadth reflects the program's interest in supporting centers that can address sex differences research through multiple disciplinary lenses while also strengthening the diversity of the biomedical research enterprise and the communities and populations that benefit from the work.

At the same time, the opportunity sets clear limits related to non-U.S. participation. Non-domestic (non-U.S.) entities (foreign organizations or foreign institutions) are not eligible to apply as the primary applicant organization, and non-domestic components of U.S. organizations are also not eligible to apply. However, "foreign components" as defined by the NIH Grants Policy Statement are allowed, meaning a U.S.-based applicant may include certain international elements (for example, specific collaborations, subprojects, or performance sites) if they meet NIH requirements and are appropriately justified, even though a foreign institution cannot serve as the applicant.

Key administrative details from the source information include the funding opportunity title "Specialized Centers of Research Excellence (SCORE) on Sex Differences (U54 Clinical Trial Optional)," funding opportunity number RFA-OD-22-014, and the sponsoring agency being the National Institutes of Health. The opportunity is categorized as discretionary, and the funding instrument type is a cooperative agreement. The activity category is listed broadly across education, environment, food and nutrition, and health, reflecting the cross-cutting nature of sex differences research and the multiple NIH components that may participate. The original closing date provided is March 14, 2025, and the record creation date is August 1, 2022. The CFDA (Assistance Listing) numbers associated with the opportunity include 93.113, 93.233, 93.242, 93.273, 93.279, 93.837, 93.838, 93.839, 93.840, 93.846, 93.847, and 93.866, indicating involvement across several NIH program areas.

Overall, this SCORE funding opportunity is aimed at supporting high-impact, center-based translational research programs that make sex differences a central scientific variable and that deliberately connect basic discovery to clinical relevance. Competitive applications will generally be expected to show a strong interdisciplinary team, a clear unifying health focus relevant to improving women's health, and an integrated plan that demonstrates how the center's combined projects and resources will generate advances that would be difficult to achieve through isolated, single-investigator efforts.

• The National Institutes of Health in the education, environment, food and nutrition, health sector is offering a public funding opportunity titled "Specialized Centers of Research Excellence (SCORE) on Sex Differences (U54 Clinical Trial Optional)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.113, 93.233, 93.242, 93.273, 93.279, 93.837, 93.838, 93.839, 93.840, 93.846, 93.847, 93.866.
• This funding opportunity was created on 2022-08-01.
• Applicants must submit their applications by 2025-03-14. (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 OD 22 014

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