Centers for Collaborative Research in Fragile X and FMR1-Associated Conditions (P50 Clinical Trial Optional) | RFA HD 20 003

Opportunity Information: Apply for RFA HD 20 003

The National Institutes of Health (NIH) funding opportunity announcement RFA-HD-20-003 supports the creation of Centers for Collaborative Research in Fragile X and FMR1-Associated Conditions, referred to as "Fragile X Centers." This is a discretionary grant mechanism using the NIH P50 center format, and it is labeled "Clinical Trial Optional," meaning applicants may propose clinical trials if they are scientifically appropriate, but a clinical trial is not required. The intent is to build coordinated, multidisciplinary research centers where multiple investigators work together in a structured way to tackle high-priority questions in Fragile X syndrome and other conditions linked to the FMR1 gene, aligned with research priorities laid out in an NIH strategic plan for this area.

A key feature of this program is the emphasis on collaboration and team science. Rather than funding isolated projects, the FOA is designed to support integrated centers that bring together complementary expertise (for example, basic science, translational research, clinical research, and potentially behavioral or health services research) to address targeted priorities. The center structure typically implies shared goals, coordinated leadership, and synergy across projects so that the overall impact is larger than what individual awards would produce separately. In practical terms, proposed centers are expected to function as hubs that accelerate discovery and translation for Fragile X and FMR1-associated conditions by aligning multiple research efforts under a unified strategy.

The opportunity falls under health-related funding activity categories and is associated with multiple CFDA numbers (93.242, 93.350, 93.853, 93.865), reflecting NIH program alignment across related institutes or program areas. The announcement lists an award ceiling of $1,300,000, indicating the maximum annual direct cost level or overall cap as specified in the FOA (applicants would still need to follow the detailed budget rules described in the full announcement). The original application due date listed for this announcement was July 3, 2020, and the FOA record shows it was created on January 16, 2020, which is useful context for understanding its timeline and whether it may have been superseded by newer opportunities.

Eligibility is broad and includes many domestic organization types commonly eligible for NIH grants. Eligible applicants include state, county, and local governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; nonprofits with or without 501(c)(3) status (other than institutions of higher education); public housing authorities/Indian housing authorities; federally recognized Native American tribal governments; and Native American tribal organizations that are not federally recognized tribal governments. The FOA also notes eligibility for for-profit organizations (other than small businesses) and small businesses, as well as an "Other" category that NIH sometimes uses to capture additional allowable applicant types described in the full policy framework.

The announcement also explicitly highlights additional eligible applicant categories that NIH aims to include and encourage, such as Alaska Native and Native Hawaiian Serving Institutions; Asian American, Native American, and Pacific Islander Serving Institutions (AANAPISIs); Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Tribally Controlled Colleges and Universities (TCCUs); faith-based or community-based organizations; eligible federal agencies; regional organizations; and U.S. territories or possessions. These statements signal an intent to broaden participation and ensure institutions serving historically underrepresented communities are clearly included among eligible applicants.

At the same time, the FOA draws clear boundaries around foreign participation. Non-domestic (non-U.S.) entities or foreign institutions are not eligible to apply as the applicant organization, and non-domestic components of U.S. organizations are also not eligible to apply. However, the announcement allows "foreign components" as defined in the NIH Grants Policy Statement. In NIH terms, that typically means a U.S.-based applicant may include certain well-justified collaborations or performance sites outside the U.S. when they are essential to the project, but the primary applicant organization must be domestic and must follow NIH rules governing foreign components.

Overall, this opportunity is best understood as support for building a coordinated research center focused on Fragile X and related FMR1-associated conditions, with the expectation that investigators will work together across disciplines to address strategic priorities, potentially including (but not requiring) clinical trial activity. The program is structured to fund a center-level effort rather than a single study, and it is open to a wide range of U.S.-based institutions, including academic, nonprofit, governmental, and certain for-profit organizations, while restricting direct foreign applications but permitting appropriately justified foreign components within a U.S.-led project.

• 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): 93.242, 93.350, 93.853, 93.865.
• This funding opportunity was created on 2020-01-16.
• Applicants must submit their applications by 2020-07-03. (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 $1,300,000.00 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.

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