Opportunity Information: Apply for RFA MH 19 121

The National Institutes of Health (NIH) funding opportunity titled "Early Screening for Autism Spectrum Disorder (R21 Clinical Trial Not Allowed)" (Funding Opportunity Number RFA-MH-19-121) supports research aimed at creating and validating new ways to screen for autism spectrum disorder (ASD) during infancy, specifically from birth through 12 months of age. The central goal is to push screening earlier than is typical in standard practice, by encouraging innovative tools, methods, or approaches that can reliably identify early signs or risk indicators of ASD in very young infants. The emphasis is on development and validation of screening methods that are appropriate for this age range, where behavioral signals can be subtle, developmental trajectories vary widely, and practical screening needs to be feasible in real-world settings.

This announcement uses the NIH R21 mechanism, which is designed for exploratory, high-potential projects that are still in earlier stages. In practical terms, this means the FOA is looking for pilot or feasibility work, proof-of-concept studies, and early-stage testing that may not yet have extensive preliminary evidence behind it. The companion opportunity noted in the description, RFA-MH-19-120, uses the R01 mechanism and is framed as a better fit for teams that already have strong preliminary data and are ready for later-stage validation, refinement, or more definitive testing of an existing screening tool or method. Applicants who are still working out whether a new approach can function as intended, can be implemented, or shows promising early performance in infants are the intended audience for the R21 pathway.

A key boundary in this specific FOA is stated directly in the title: "Clinical Trial Not Allowed." That signals the projects should not be structured as clinical trials as defined by NIH policy, and proposals should stay within non-trial research designs consistent with tool development, measurement validation, and related exploratory studies. In other words, the focus is on building and validating screening methods rather than testing intervention efficacy or running trials that prospectively assign participants to interventions.

The funding is offered as a discretionary grant, and the listed award ceiling is $200,000 (as provided in the source data). The opportunity falls under NIH funding activity areas that span health and social services-related research, and it is associated with multiple CFDA numbers (93.113, 93.173, 93.242, 93.853, 93.865), reflecting the cross-cutting federal assistance cataloging that NIH uses across institutes and programs. The original application closing date shown in the source information is February 4, 2019, and the FOA record creation date is October 25, 2018, which situates this as a time-specific call from that period.

Eligibility is broad and includes many common applicant categories in NIH programs, spanning public and private institutions and community-based entities. Eligible applicants listed 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; federally recognized Native American tribal governments; Native American tribal organizations that are not federally recognized; public housing authorities and Indian housing authorities; nonprofit organizations with or without 501(c)(3) status (excluding institutions of higher education in those nonprofit categories); for-profit organizations other than small businesses; and small businesses. The FOA also explicitly highlights additional eligible groups and institution types, including Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISISs); Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Tribally Controlled Colleges and Universities (TCCUs); faith-based or community-based organizations; eligible federal agencies; U.S. territories or possessions; regional organizations; and even non-U.S. (foreign) organizations. Taken together, the eligibility language signals an intent to encourage a diverse set of applicants and settings, which is often important in ASD screening research because early identification tools need to work across populations, communities, and care contexts.

Overall, this FOA is best read as an NIH call for early-stage, non-clinical-trial research that can move the field toward reliable ASD screening in the first year of life. It is designed to help investigators test new ideas and generate the kind of evidence that could later justify larger, more definitive studies (often under an R01), while also supporting a wide range of organizations capable of contributing to early screening innovation and validation.

  • The National Institutes of Health in the environment, health, income security and social services sector is offering a public funding opportunity titled "Early Screening for Autism Spectrum Disorder (R21 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, 93.865.
  • 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 $200,000.00 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 19 121

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