Centers for Collaborative Research in Fragile X and FMR1-Associated Conditions (P50 Clinical Trial Optional) | RFA HD 25 002

Opportunity Information: Apply for RFA HD 25 002

The National Institutes of Health is soliciting new applications for Centers for Collaborative Research in Fragile X and FMR1-Associated Conditions under a P50 center grant mechanism (clinical trial optional), through funding opportunity RFA-HD-25-002. The purpose of this competition is to support integrated, collaborative research centers ("Fragile X Centers") that tackle major unanswered questions in Fragile X and other conditions linked to the FMR1 gene. Even with strong progress in basic and clinical research, NIH is emphasizing that important gaps remain in understanding why people with FMR1-associated conditions can look so different clinically and why they can respond differently to interventions. This NOFO makes that problem the central organizing principle for every proposed center.

A defining requirement is that each applicant center must establish a single overarching theme that directly aims to broaden understanding of phenotypic heterogeneity (the wide variability in clinical features across individuals) and/or variability in response to interventions in one or more FMR1-associated conditions. In practice, that means applicants cannot propose a loose collection of projects; the program is looking for centers where multiple projects and shared resources are clearly aligned to a unifying scientific question about sources of variability, such as genetic modifiers, molecular and cellular mechanisms, developmental timing, environmental or contextual influences, comorbidities, sex differences, or measurable biomarkers that predict outcomes or treatment response.

NIH expects funded centers to be genuinely multidisciplinary and collaborative, bringing together investigators across basic science, translational research, clinical research, and/or data science. A key emphasis is the use of precision medicine approaches, meaning the research should move beyond one-size-fits-all explanations and instead try to determine which mechanisms, risk factors, or interventions are most relevant for specific subgroups or individual patients. Centers are encouraged to integrate human data and mechanistic work in ways that allow findings to translate into better stratification of patients, improved outcome measurement, and more targeted intervention strategies over time. Because the NOFO is labeled "clinical trial optional," a center may include clinical trials if they are allowed under the announcement, but clinical trials are not mandatory; the crucial point is that any proposed trials must fit the NOFO's specific rules about what trial types are permissible.

This opportunity includes several compliance-oriented requirements that applicants have to treat as nonnegotiable. The NOFO specifies requirements related to whether the center includes research involving human subjects or human phenotypic data, expectations around diversity in participants and/or the materials being studied, the allowable types of clinical trials, and the involvement of early-stage investigators. The announcement is explicit that applications failing to follow these requirements will be considered nonresponsive and withdrawn, so centers need to design their research plan and staffing model to fit these constraints from the beginning rather than treating them as add-ons.

Another central requirement is a Plan for Enhancing Diverse Perspectives (PEDP). NIH will evaluate the PEDP during peer review as part of the scientific and technical assessment, and an application that does not include a PEDP will be judged incomplete and withdrawn. The intent is to push centers to build teams, training environments, partnerships, and scientific approaches that incorporate a broader range of perspectives, which can include (but is not limited to) disciplinary diversity, career-stage diversity, and inclusion of perspectives shaped by different backgrounds, communities, and lived experiences. NIH strongly encourages applicants to consult the PEDP instructions and guidance materials and to respond directly to what the announcement asks for, since omission or superficial treatment creates a high risk of administrative withdrawal.

Eligibility is broad across U.S.-based organizations and includes many common applicant categories such as state and local governments, public and private institutions of higher education, nonprofit organizations (with or without 501(c)(3) status), for-profit organizations (other than small businesses), and small businesses, as well as certain tribal governments and housing authorities. The NOFO also highlights categories of institutions often associated with broadening participation, including Alaska Native and Native Hawaiian Serving Institutions, AANAPISIs, Hispanic-serving Institutions, Historically Black Colleges and Universities, Tribally Controlled Colleges and Universities, and faith-based or community-based organizations, among others. Despite that broad domestic eligibility, non-domestic (non-U.S.) entities are not eligible to apply, and non-domestic components of U.S. organizations are not eligible. At the same time, foreign components are allowed as defined by NIH Grants Policy, which generally means a U.S. applicant can include certain international collaborations or performance sites if they are justified, structured appropriately, and compliant with NIH policy.

Administratively, this is a discretionary NIH grant opportunity in the health domain, with activity focused on Fragile X and related FMR1-associated conditions, and it is associated with multiple CFDA numbers (93.173, 93.242, 93.853, 93.865). The original closing date listed is August 21, 2024, and the opportunity was created June 7, 2024. While the excerpt does not provide an award ceiling or expected number of awards, the P50 mechanism typically implies a substantial, multi-project center structure with shared cores and coordinated leadership, so proposals usually need to demonstrate strong governance, clear integration across projects, and a compelling case that the center model is necessary to accomplish the overarching theme about phenotypic variability and intervention response.

• The National Institutes of Health in the health, income security and social services sector is offering a public funding opportunity titled "Centers for Collaborative Research in Fragile X and FMR1-Associated Conditions (P50 Clinical Trial Optional)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.173, 93.242, 93.853, 93.865.
• This funding opportunity was created on 2024-06-07.
• Applicants must submit their applications by 2024-08-21. (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.

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