Innovative Approaches for Improving Environmental Health Literacy (R43/R44 Clinical Trial Not Allowed) | RFA ES 21 008

Opportunity Information: Apply for RFA ES 21 008

The grant opportunity called "Innovative Approaches for Improving Environmental Health Literacy (R43/R44 Clinical Trial Not Allowed)" is a National Institutes of Health (NIH) Small Business Innovative Research (SBIR) funding announcement designed to help small businesses create practical, innovative ways to strengthen environmental health literacy. The core idea is to fund early-stage and later-stage product development that helps people better understand how environmental exposures affect health, and how to find, interpret, and use trustworthy environmental health information in real-world decisions. Rather than funding basic research for its own sake, this announcement is aimed at producing tangible tools, activities, or educational materials that can be used by specific audiences in communities, schools, and professional settings.

This FOA supports SBIR projects across Phase I (R43), Phase II (R44), and a Fast-Track option (R44) that combines Phase I and Phase II into a single application pathway. In general terms, Phase I typically focuses on establishing feasibility and developing an early prototype or proof of concept, while Phase II supports more advanced research and development such as refinement, usability testing, and preparing for broader implementation or commercialization. The Fast-Track route is meant for teams that can credibly move from feasibility to a more developed product on an accelerated timeline, with a clear development plan and milestones.

A central requirement in the description is collaboration: small business concerns are expected to work in collaboration with environmental science researchers. This reflects the intent that the products or interventions funded should be grounded in credible environmental health science, while still being designed and packaged in ways that non-specialists can understand and act on. The audience focus is intentionally broad. Projects may target community members who need practical guidance about environmental risks in daily life, health care and public health professionals who communicate risk and prevention, educators who incorporate environmental health into curricula, and students of all ages who are building foundational knowledge and decision-making skills.

The topic area, as framed by the funding activity category "Environment, Health" (CFDA 93.113), is environmental health literacy. That generally involves more than awareness or knowledge; it includes the ability to access relevant information, evaluate quality and credibility, understand uncertainty and risk, and apply information to choices at the personal, family, school, workplace, clinical, or community level. Because the FOA emphasizes "novel tools, activities, or materials," projects could reasonably include digital platforms, interactive learning modules, decision aids, risk communication resources, professional training materials, classroom curricula, community engagement toolkits, or other innovative formats that make environmental health information understandable and usable. The announcement does not list specific allowable formats in the provided text, but it clearly encourages creativity as long as the end product builds environmental health literacy in a measurable and meaningful way.

This opportunity is explicitly labeled "Clinical Trial Not Allowed," meaning applicants should not propose research that meets NIH's definition of a clinical trial. In practice, that typically means you can evaluate educational tools, communication materials, or technology products in ways that do not involve assigning human participants to interventions with the intent of measuring health-related biomedical or behavioral outcomes in a clinical-trial framework. Projects can still involve user-centered design, usability testing, and some forms of evaluation, but they need to be structured so they do not cross into prohibited clinical trial territory under NIH policy. Applicants usually address this by focusing on feasibility, design validation, acceptability, comprehension testing, and implementation-related outcomes rather than clinical endpoints, and by carefully describing how any human-subjects work is conducted.

Eligibility is restricted primarily to small businesses, consistent with SBIR requirements. The announcement also makes clear that non-U.S. entities are not eligible to apply: foreign institutions cannot be the applicant organization, and non-domestic components of U.S. organizations are also not eligible to apply. However, foreign components, as NIH defines them in the NIH Grants Policy Statement, may be allowed. That typically means a U.S.-based applicant might be able to include a limited, well-justified foreign collaboration component if it is necessary for the project and consistent with NIH policy, but the applicant organization itself must be domestic and meet SBIR small business criteria.

Administrative details included in the source data indicate this is a discretionary grant program administered by NIH, with the funding opportunity number RFA-ES-21-008 and an original closing date of 2021-11-10. The CFDA number is 93.113, and the agency is listed as the National Institutes of Health. An explicit award ceiling is not provided in the supplied data, and the expected number of awards is also not specified in the snippet, which suggests applicants would need to consult the full FOA for budget limits, project period expectations, and any institute-specific funding parameters.

Overall, the opportunity is best understood as NIH support for small businesses to build and test innovative, science-based products that help diverse audiences understand environmental health risks and act on that knowledge. The emphasis on collaboration with environmental science researchers, the focus on scalable tools and materials, and the SBIR phase structure all point toward projects that can mature into deployable resources with real-world reach, while staying within the boundaries of non-clinical-trial research and development.

• The National Institutes of Health in the environment, health sector is offering a public funding opportunity titled "Innovative Approaches for Improving Environmental Health Literacy (R43/R44 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.
• This funding opportunity was created on 2021-08-12.
• Applicants must submit their applications by 2021-11-10. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Eligible applicants include: Small businesses.

Apply for RFA ES 21 008

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