Early Screening for Autism Spectrum Disorder (R01 Clinical Trial Not Allowed) | RFA MH 19 120

Opportunity Information: Apply for RFA MH 19 120

The Early Screening for Autism Spectrum Disorder (R01 Clinical Trial Not Allowed) funding opportunity (RFA-MH-19-120) is a National Institutes of Health (NIH) discretionary grant program designed to push autism screening much earlier than is typical in routine practice. Its central aim is to support research that develops and validates new screening methods for autism spectrum disorder (ASD) that can be used during infancy, specifically from birth through 12 months of age. In practical terms, the opportunity is looking for tools, measures, or approaches that can reliably identify early ASD risk signals in the first year of life, when standard diagnostic clarity is often limited and when earlier identification could improve the timing of supports and services.

This announcement uses the R01 research project grant mechanism, which generally fits projects that already have a solid foundation of preliminary evidence and are ready for more rigorous testing. The FOA explicitly contrasts itself with a related NIH opportunity that uses the R21 mechanism (RFA-MH-19-121). The intent behind that split is straightforward: projects that are more exploratory, have limited preliminary data, or are focused on early feasibility and proof-of-concept work are steered toward the R21 pathway, while teams that already have strong preliminary data and want to conduct validation, refinement, or later-stage testing of an existing screening method are better matched to this R01. The phrase "Clinical Trial Not Allowed" signals that applications should not propose clinical trials as defined by NIH; the work is expected to center on screening method development and validation rather than testing an intervention’s effects on health-related outcomes.

The scope of applicants is broad and includes many types of public and private organizations. Eligible applicants include state, county, 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; and Native American tribal organizations that are not federally recognized. It also includes public housing authorities and Indian housing authorities, nonprofits with and without 501(c)(3) status (as long as they are not institutions of higher education in that nonprofit category), for-profit organizations other than small businesses, and small businesses. Beyond those standard categories, the FOA highlights additional eligible groups 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; tribal governments other than federally recognized entities; non-domestic (non-U.S.) entities (foreign organizations); and U.S. territories or possessions. This wide eligibility is meant to encourage participation from diverse research settings and communities, which matters for screening research because performance, feasibility, and acceptability can vary across populations and care contexts.

From an administrative and funding standpoint, the opportunity is listed under NIH with an original closing date of February 4, 2019, and a stated award ceiling of $500,000. The CFDA numbers associated with the program include 93.113, 93.173, 93.242, and 93.853, and the activity category is listed under environment and health. The funding instrument is a grant, and the opportunity category is discretionary, consistent with NIH research funding announcements. Overall, this FOA is best read as an NIH call for mature, well-supported research projects focused on producing and validating practical, evidence-based ASD screening approaches that can work within the first year of life and that are ready for rigorous evaluation short of a clinical trial.

• The National Institutes of Health in the environment, health sector is offering a public funding opportunity titled "Early Screening for Autism Spectrum Disorder (R01 Clinical Trial Not Allowed)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.113, 93.173, 93.242, 93.853.
• This funding opportunity was created on 2018-10-25.
• Applicants must submit their applications by 2019-02-04. (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 $500,000.00 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.

Apply for RFA MH 19 120

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