NIAID, NIDDK, NIDA, and NIAAA Research Opportunities for New and "At-Risk" Investigators (R01 Clinical Trial Optional) | PA 25 249

Opportunity Information: Apply for PA 25 249

The funding opportunity titled "NIAID, NIDDK, NIDA, and NIAAA Research Opportunities for New and 'At-Risk' Investigators (R01 Clinical Trial Optional)" (Funding Opportunity Number PA-25-249) is a discretionary NIH grant mechanism using the R01 research project grant format, with clinical trials allowed but not required. It is described as an SRF reissue and is designed to strengthen and sustain the biomedical research workforce by helping investigators who are either early in their independent careers or at a vulnerable transition point where their research programs could lose momentum due to a gap in major NIH funding. The opportunity specifically emphasizes projects that fit within the scientific missions of NIAID or NIDDK, even though the title references additional NIH institutes (NIDA and NIAAA). In practical terms, applicants should make sure their proposed aims clearly align with NIAID- or NIDDK-relevant priorities, since mission fit is central to responsiveness.

The core intent is to encourage strong, competitive R01 applications from two investigator groups. First, "New Investigators" are researchers who have not previously won substantial, independent NIH funding. Second, "At-Risk" investigators are those who previously served as a PD/PI on a substantial independent research award but are in danger of losing all substantial research grant support in the next fiscal year unless they secure a new substantial award in the current fiscal year. The NOFO explicitly highlights inclusion of investigators from diverse backgrounds, including individuals from groups underrepresented in the health-related sciences, reflecting NIH-wide priorities around broadening participation and promoting a more representative scientific workforce.

Eligibility is broad across many types of U.S.-based organizations, which makes this opportunity accessible beyond the traditional research university setting. Eligible applicants 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 tribal governments; tribal organizations that are not federally recognized; public housing authorities and Indian housing authorities; nonprofits (both 501(c)(3) and non-501(c)(3), excluding higher education institutions in those categories as specified); for-profit organizations (other than small businesses); and small businesses. The NOFO also calls out additional eligible organization types such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving Institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), as well as faith-based or community-based organizations, eligible federal agencies, regional organizations, and U.S. territories or possessions. A key restriction is that non-U.S. entities (foreign organizations) are not eligible to apply under this announcement, so the applicant organization must be U.S.-based even if aspects of the research involve international components permitted under NIH rules.

From an administrative standpoint, the opportunity is run by the National Institutes of Health and is associated with CFDA numbers 93.273, 93.279, 93.847, and 93.855, which correspond to different NIH program areas tied to the participating institutes. The listed original closing date is 2025-09-07. The posting does not provide an award ceiling or expected number of awards in the excerpted data, so budgets and award volumes should be confirmed in the full NOFO and related NIH budget guidance for R01 applications (including any institute-specific paylines, caps, or preferences that may apply in a given fiscal year).

Overall, this NOFO is best understood as a targeted pathway into (or back into) stable NIH R01 support for investigators who are new to major independent funding or who are at risk of losing it, with an emphasis on building a resilient and diverse research community. Applicants are expected to propose a well-justified, mission-aligned research project of the scope and rigor appropriate for an R01, with the option to include a clinical trial when scientifically appropriate, and to apply through an eligible U.S. organization type that meets NIH requirements.

• The National Institutes of Health in the education, food and nutrition, health sector is offering a public funding opportunity titled "NIAID, NIDDK, NIDA, and NIAAA Research Opportunities for New and "At-Risk" Investigators (R01 Clinical Trial Optional)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.273, 93.279, 93.847, 93.855.
• This funding opportunity was created on 2024-12-31.
• Applicants must submit their applications by 2025-09-07. (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 PA 25 249

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