Specialized Centers of Research Excellence (SCORE) on Sex Differences (U54 Clinical Trial Optional) | RFA OD 19 013

Opportunity Information: Apply for RFA OD 19 013

The Specialized Centers of Research Excellence (SCORE) on Sex Differences (U54 Clinical Trial Optional) grant opportunity (RFA-OD-19-013) is a National Institutes of Health (NIH) cooperative agreement led by the Department of Health and Human Services through NIH, with the Office of Research on Women's Health (ORWH) and participating NIH Institutes and Centers. The core purpose of this program is to establish or support Centers of Excellence that use interdisciplinary, team-based science to advance translational research focused on sex differences. In practical terms, the program is looking for institutions to build coordinated research centers that connect basic (mechanistic, laboratory, preclinical) discovery to clinical research, with the explicit goal of improving the health of women by better understanding how biological sex influences health and disease.

A key theme of the opportunity is the expectation that each funded SCORE site will be more than a collection of separate projects. The center is intended to operate as an integrated research enterprise with a clear, cohesive agenda centered on one or more health issues where sex differences matter and where there is a meaningful pathway from foundational science to patient-oriented impact. The NIH emphasis on translational work means applicants are expected to show how their basic research questions inform clinical hypotheses, how clinical observations feed back into mechanistic studies, and how the center will move the field toward better prevention strategies, diagnostics, or treatments that account for sex-based biology. Because the funding mechanism is a U54 cooperative agreement, awardees should also anticipate substantial scientific involvement from NIH staff compared to a standard research grant, often including coordination, milestone expectations, and programmatic oversight designed to keep the center aligned with the initiative's goals.

The "Clinical Trial Optional" designation signals that the program can support centers that include clinical trials, but does not require that every application propose a clinical trial component. Applicants may propose clinical research that ranges from observational and human-subjects studies to interventional trials when appropriate for the center's aims. This flexibility is meant to accommodate different translational strategies while still keeping the focus on bridging basic and clinical research in a structured, center-based format.

Eligibility is broad and includes a wide range of domestic organizations and governmental entities. Eligible applicants listed for this opportunity include state, county, and city or township governments; 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 and without 501(c)(3) status (other than institutions of higher education); for-profit organizations other than small businesses; small businesses; and other entities as described in the solicitation's additional eligibility language. This wide eligibility reflects NIH's intent to encourage diverse institutions with the capability to run complex, collaborative research centers to apply, as long as they can demonstrate the infrastructure and leadership needed to deliver a cohesive SCORE program.

From a funding standpoint, the opportunity was posted with an award ceiling of $1,000,000 and an expectation of about five awards. As a center-focused mechanism, applicants would typically be expected to justify how the requested funds support an integrated set of activities that collectively advance the SCORE mission, rather than isolated efforts. The program is categorized under health-related funding activity areas, and it is associated with multiple CFDA numbers (93.113, 93.242, 93.273, 93.279, 93.313, 93.846, 93.847, 93.866), reflecting participation across multiple NIH components and the cross-cutting nature of sex-differences research.

Administrative details provided for this specific announcement indicate it was created on November 26, 2018, with an original closing date of January 10, 2019. Even though those dates reflect a past cycle for this particular posting, the content clarifies the kind of center NIH wanted to build: interdisciplinary, translational, sex-differences-focused, and explicitly relevant to improving the health of women. In short, the SCORE program is designed to concentrate expertise, infrastructure, and coordinated research projects into a single center that can generate deeper mechanistic understanding of sex differences while accelerating progress toward clinical relevance and real-world improvements in women's health outcomes.

• The Department of Health and Human Services, 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, 93.242, 93.273, 93.279, 93.313, 93.846, 93.847, 93.866.
• This funding opportunity was created on Nov 26, 2018.
• Applicants must submit their applications by Jan 10, 2019. (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 $1,000,000.00 in funding.
• The number of recipients for this funding is limited to 5 candidate(s).
• 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 (see text field entitled Additional Information on Eligibility for clarification).

Apply for RFA OD 19 013

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