Opportunity Information: Apply for RFA ES 09 005

  • The National Institutes of Health in the environment health sector is offering a public funding opportunity titled "Environmental Sensors for Personal Exposure Assessment(SBIR R44)" and is now available to receive applicants.
  • Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.113 Environmental Health.
  • This funding opportunity was created on Feb 26, 2009 and posted on Feb 26, 2009.
  • Applicants must submit their applications by Apr 28, 2009. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
  • The funding agency has allocated a total of $10,000,000.00 to eligible and selected applicants.
  • Eligible applicants include: Small businesses.
  • Other Eligible Applicants include the following Only United States small business concerns (SBCs) are eligible to submit SBIR applications. A small business concern is one that, at the time of award of SBIR Phase I and Phase II, meets all of the following criteria 1. Is organized for profit, with a place of business located in the United States, which operates primarily within the United States or which makes a significant contribution to the United States economy through payment of taxes or use of American products, materials or labor 2. Is in the legal form of an individual proprietorship, partnership, limited liability company, corporation, joint venture, association, trust or cooperative, except that where the form is a joint venture, there can be no more than 49 percent participation by foreign business entities in the joint venture 3. Is at least 51 percent owned and controlled by one or more individuals who are citizens of, or permanent resident aliens in, the United States, or it must be a for profit business concern that is at least 51 owned and controlled by another for profit business concern that is at least 51 owned and controlled by one or more individuals who are citizens of, or permanent resident aliens in, the United States, except in the case of a joint venture, where each entity to the venture must be 51 percent owned and controlled by one or more individuals who are citizens of, or permanent resident aliens in, the United States and 4. Has, including its affiliates, not more than 500 employees. SBCs must also meet the other regulatory requirements found in 13 C.F.R. Part 121. Business concerns, other than investment companies licensed, or state development companies qualifying under the Small Business Investment Act of 1958, 15 U.S.C. 661, et seq., are affiliates of one another when either directly or indirectly, (a) one concern controls or has the power to control the other or (b) a third party/parties controls or has the power to control both. Control can be exercised through common ownership, common management, and contractual relationships. The term affiliates is defined in greater detail in 13 C.F.R. 121.3 2(a). The term number of employees is defined in 13 C.F.R. 121.3 2(t).
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Opportunity Summary:

The Environmental Sensors for Personal Exposure Assessment (SBIR R44) opportunity, issued by the National Institutes of Health (NIH) under Funding Opportunity Number RFA-ES-09-005, was a discretionary SBIR Phase II grant program focused on advancing practical tools for measuring how people are exposed to environmental hazards. The core goal was to push small businesses to develop field-deployable and/or wearable personal sensing technologies that can quantify a person s exposure to a broad range of airborne chemical and biological agents. A defining emphasis of the announcement is that measurement should happen close to where exposure actually occurs, meaning at the point of contact with the body (such as the nose, mouth, or skin) and/or through simple, accessible biosamples that can be collected with minimal burden, including buccal cells, finger-prick blood, exhaled breath, urine, or saliva. The intent was to enable monitoring that is not only accurate, but also timely enough to support near real-time and even continuous readouts of exposure.

In practical terms, the FOA called for sensor systems capable of producing quantitative measurements of multiple analytes rather than a single target. This multi-analyte capability matters because real-world exposures often involve mixtures of agents, and because understanding exposure profiles over time can be critical for linking environmental conditions to health outcomes. The program placed strong weight on near real-time performance, suggesting an interest in technology that can track changes in exposure as they happen, rather than relying solely on retrospective sampling. Alongside external exposure measurements, the FOA also supported approaches that assess internal exposure through biosamples, meaning technologies that can indicate what has entered or is present in the body, not just what is in the surrounding air.

A second major track within the opportunity involved developing and refining panels of biomarkers that reflect biological responses to environmental stressors. Instead of measuring the hazard directly, biomarker panels aim to capture how the body is responding at a molecular or physiological level. The FOA specified that these biomarkers should map to key physiologic and pathophysiologic pathways that are relevant to human disease, reinforcing that the program was not only about engineering devices, but also about ensuring that the biological signals being measured are meaningful for health research. In other words, successful projects would connect exposure science with mechanisms tied to disease processes, making the resulting tools more useful for environmental health studies.

A notable expectation in the announcement is readiness for real-world research use by the end of the award period. NIH anticipated that devices developed under this FOA would be fully developed and validated so they could be applied in population studies once the funding period ends. That language signals that proposals were expected to move beyond early prototypes and address performance validation, reliability, and practical deployment considerations that would matter in large-scale studies involving many participants. It also implies attention to usability and robustness, since population research often requires tools that can operate consistently outside controlled laboratory conditions.

From an administrative and eligibility standpoint, this was an SBIR Phase II (R44) grant, meaning it targeted U.S. small business concerns that already had sufficient prior development to justify Phase II work. Only U.S. for-profit small businesses meeting SBIR size and ownership requirements were eligible. The FOA reiterated standard SBIR eligibility rules, including that the business must be organized for profit, have a place of business in the United States, operate primarily in the United States or contribute significantly to the U.S. economy, be no more than 500 employees including affiliates, and be majority owned and controlled (at least 51 percent) by U.S. citizens or permanent residents (with additional rules for joint ventures and affiliates). There was no cost sharing or matching requirement.

Key timing and funding details included a posted date of February 26, 2009, with an original and current closing date of April 28, 2009, and an archive date of May 29, 2009. The estimated total funding listed for the opportunity was $10,000,000, and it fell under the Environmental Health activity category (CFDA 93.113). Overall, the announcement reflects NIH s interest at the time in accelerating wearable and field-ready exposure assessment technologies, pairing direct detection of environmental agents with biologically informative measures of internal exposure and response, and delivering validated tools suitable for population-level environmental health research.

Frequently Asked Questions (FAQs)

What is the Environmental Sensors for Personal Exposure Assessment (SBIR R44) opportunity?

It was a discretionary NIH SBIR Phase II (R44) funding opportunity focused on advancing practical tools for measuring how people are exposed to environmental hazards. The emphasis was on technologies that can be used in the field and/or worn by individuals to quantify personal exposure.

Which agency and program issued this funding opportunity?

The opportunity was issued by the National Institutes of Health (NIH) as an SBIR Phase II (R44) program under Funding Opportunity Number (FON) RFA-ES-09-005.

What was the main goal of the FOA?

The main goal was to push small businesses to develop field-deployable and/or wearable personal sensing technologies that can provide quantitative measurements of personal exposure to a broad range of airborne chemical and biological agents.

What does "personal exposure assessment" mean in this FOA?

It refers to measuring exposure close to where it actually occurs for an individual, including at the point of contact with the body (for example, at the nose, mouth, or skin) and/or via simple biosamples that can be collected with minimal burden.

What kinds of hazards were the sensors intended to measure?

The FOA emphasized a broad range of airborne chemical and biological agents, reflecting real-world exposure situations.

What did the FOA mean by measuring at the "point of contact" with the body?

It meant capturing exposure as close as possible to the actual interface where environmental agents reach the body, such as the nose, mouth, or skin, rather than relying only on measurements taken farther away in the surrounding environment.

What biosamples were highlighted as acceptable for internal exposure assessment?

The FOA gave examples of simple, accessible biosamples that could be collected with minimal burden, including buccal cells, finger-prick blood, exhaled breath, urine, and saliva.

Was near real-time or continuous monitoring important to this FOA?

Yes. The FOA placed strong weight on monitoring that is timely enough to support near real-time and even continuous readouts, so exposure changes can be tracked as they happen rather than only retrospectively.

Did the FOA expect sensors to be quantitative?

Yes. The sensor systems were expected to produce quantitative measurements, not just qualitative indicators.

Were projects expected to measure multiple analytes or a single target?

The FOA called for sensor systems capable of producing quantitative measurements of multiple analytes, not just a single target, because real-world exposures often involve mixtures and changing exposure profiles over time.

Did the opportunity support approaches beyond direct detection of environmental agents?

Yes. In addition to direct external exposure measurements, the FOA supported approaches that assess internal exposure through biosamples, and it also supported developing and refining panels of biomarkers that reflect biological responses to environmental stressors.

What are biomarker panels in the context of this FOA?

Biomarker panels are sets of biological indicators intended to reflect how the body is responding to environmental stressors. Instead of detecting the hazard directly, they aim to capture molecular or physiological responses that can be linked to relevant health and disease pathways.

What did the FOA require about the biological relevance of biomarkers?

The FOA specified that biomarkers should map to key physiologic and pathophysiologic pathways relevant to human disease, reinforcing that measured signals should be meaningful for environmental health research and disease mechanisms.

What level of readiness was expected by the end of the award period?

NIH anticipated that devices developed under the FOA would be fully developed and validated so they could be applied in population studies after the funding period ends. This implies moving beyond early prototypes and addressing validation, reliability, and deployment considerations needed for real-world research use.

Why did the FOA emphasize validation and population study readiness?

Because the intended endpoint was practical research use, especially in population studies where tools must operate consistently outside controlled laboratory conditions and be usable and robust across many participants.

What grant mechanism was used for this opportunity?

This was an SBIR Phase II (R44) grant opportunity, intended for small businesses that already had sufficient prior development to justify Phase II work.

Who was eligible to apply?

Only U.S. for-profit small business concerns meeting SBIR size and ownership requirements were eligible.

What SBIR size requirement applied to the business?

The business had to have no more than 500 employees, including affiliates.

What ownership and control requirements applied?

The FOA reiterated standard SBIR rules, including that the business must be majority owned and controlled (at least 51 percent) by U.S. citizens or permanent residents, with additional rules applying for joint ventures and affiliates.

Did the business need to be based in the United States?

Yes. The FOA stated that the business must have a place of business in the United States and operate primarily in the United States or contribute significantly to the U.S. economy.

Was cost sharing or matching required?

No. The FOA stated there was no cost sharing or matching requirement.

What was the posted date for the opportunity?

The posted date was February 26, 2009.

What was the closing date?

The original and current closing date listed was April 28, 2009.

When was the opportunity archived?

The archive date was May 29, 2009.

How much total funding was estimated for the opportunity?

The estimated total funding listed was $10,000,000.

What activity category and CFDA number were associated with this FOA?

The opportunity fell under the Environmental Health activity category and listed CFDA 93.113.

What types of technologies were most aligned with the FOA priorities?

Technologies aligned with the FOA included field-deployable and wearable sensor systems for personal exposure measurement, multi-analyte quantitative sensing, near real-time or continuous monitoring capabilities, biosample-based internal exposure assessment tools, and biomarker panels tied to disease-relevant biological pathways.

Why did the FOA emphasize measuring mixtures and exposure profiles over time?

The FOA highlighted multi-analyte and near real-time performance because real-world exposures often involve mixtures of agents and because exposure patterns over time can be important for linking environmental conditions to health outcomes.

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