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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Frequently Asked Questions (FAQs)

What is the "Innovative Approaches for Improving Environmental Health Literacy (R43/R44 Clinical Trial Not Allowed)" opportunity?

This is a National Institutes of Health (NIH) Small Business Innovative Research (SBIR) funding announcement that supports small businesses developing practical, innovative ways to strengthen environmental health literacy. The focus is on producing tangible tools, activities, or educational materials that help people understand how environmental exposures affect health and how to find, interpret, and use trustworthy environmental health information in real-world decisions.

What is the main goal of this funding announcement?

The main goal is to fund product-oriented research and development (R&D) that results in deployable resources (not basic research for its own sake). Projects should improve the ability of specific audiences to access environmental health information, judge its credibility, understand risk and uncertainty, and apply it to decisions at personal, family, school, workplace, clinical, or community levels.

Who is the funding agency?

The administering agency is the National Institutes of Health (NIH).

What is the funding opportunity number (FOA number)?

The FOA number listed is RFA-ES-21-008.

What type of grant mechanism is this?

This is an NIH SBIR opportunity supporting Phase I (R43), Phase II (R44), and a Fast-Track option (R44) that combines Phase I and Phase II into a single application pathway.

What is the difference between Phase I (R43) and Phase II (R44) for this SBIR opportunity?

Phase I (R43) generally focuses on establishing feasibility and developing an early prototype or proof of concept. Phase II (R44) generally supports more advanced R&D, such as refining the product, conducting usability testing, and preparing for broader implementation or commercialization.

What is the Fast-Track option in this opportunity?

The Fast-Track option (R44) allows an applicant to propose Phase I and Phase II activities together in a single application. It is intended for teams that can credibly move from feasibility to a more developed product on an accelerated timeline, supported by a clear development plan and milestones.

What kinds of projects are a fit for this opportunity?

Projects should result in novel tools, activities, or materials that strengthen environmental health literacy in a meaningful, measurable way. The provided description suggests the program is open to creative formats, as long as the end product helps people understand environmental exposures and use credible environmental health information in decisions.

What are examples of potential product formats under this FOA?

While the provided text does not list a definitive set of allowable formats, it indicates that 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 resources designed to make environmental health information understandable and usable.

Who are the intended audiences for the tools or materials developed?

The audience focus is broad and may include community members, health care and public health professionals, educators, and students of all ages. The key is that the product is designed for real-world use by a defined audience and supports actionable understanding of environmental health information.

Is collaboration required for applicants?

Yes. The description emphasizes collaboration: small business concerns are expected to work in collaboration with environmental science researchers. This is meant to ensure the resulting products are grounded in credible environmental health science while still being understandable and usable by non-specialists.

What topic area does this funding opportunity fall under?

The topic area is environmental health literacy under the activity category "Environment, Health" with CFDA 93.113.

What does "environmental health literacy" mean in the context of this FOA?

In this context, environmental health literacy goes beyond awareness. It includes the ability to access relevant information, evaluate quality and credibility, understand uncertainty and risk, and apply information to choices and decisions in everyday settings.

Does this FOA allow clinical trials?

No. The opportunity is explicitly labeled "Clinical Trial Not Allowed." Applicants should not propose research that meets NIH's definition of a clinical trial.

If clinical trials are not allowed, can projects still involve people (human participants) in testing?

The description indicates projects can involve user-centered design, usability testing, and some forms of evaluation, but these activities must be structured so they do not meet NIH's clinical trial definition. The examples provided emphasize focusing on feasibility, design validation, acceptability, comprehension testing, and implementation-related outcomes rather than clinical endpoints.

What kinds of evaluation activities are implied as acceptable under "Clinical Trial Not Allowed"?

Based on the description, acceptable activities may include feasibility testing, prototype development and refinement, usability testing, acceptability assessments, comprehension testing, and implementation-oriented evaluation, as long as the work is not designed as a clinical trial intended to measure health-related biomedical or behavioral outcomes in a clinical-trial framework.

Who is eligible to apply?

Eligibility is restricted primarily to small businesses, consistent with SBIR requirements.

Are foreign (non-U.S.) organizations eligible to apply as the applicant?

No. The description states 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.

Are any foreign components allowed in a project?

The description notes that foreign components, as NIH defines them in the NIH Grants Policy Statement, may be allowed. This typically means a U.S.-based applicant might include a limited, well-justified foreign collaboration component if necessary and consistent with NIH policy, but the applicant organization must be domestic and meet SBIR small business criteria.

Is there an award ceiling (maximum award amount) listed in the provided information?

No. The provided data does not include an explicit award ceiling.

Is the expected number of awards listed in the provided information?

No. The expected number of awards is not specified in the provided snippet.

What is the closing date shown in the provided information?

The source data indicates an original closing date of 2021-11-10.

What kind of grant program is this described as?

It is described as a discretionary grant program administered by NIH.

What is the core emphasis of the FOA: research or product development?

The emphasis is on producing tangible, practical outputs (tools, activities, or educational materials) that can be used in communities, schools, and professional settings. The description explicitly contrasts this with funding basic research for its own sake.

What makes a project "innovative" under this opportunity, based on the description?

Innovation is framed as creating novel approaches and formats that translate credible environmental health science into resources people can actually use. The description suggests creativity is encouraged, provided the product strengthens environmental health literacy in a measurable and meaningful way.

How should applicants think about real-world use and reach?

The description emphasizes scalable tools and materials intended for real-world settings and decisions, with development pathways aligned to SBIR phases that support maturation into deployable resources with broader implementation or commercialization potential.

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