Opportunity Information: Apply for RFA ES 12 004

  • The National Institutes of Health in the environment health sector is offering a public funding opportunity titled "Novel Technologies for Rapid and Sensitive Biomonitoring in Humans (SBIR R43/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 Dec 15, 2011 and posted on Dec 15, 2011.
  • Applicants must submit their applications by Feb 23, 2012. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
  • The funding agency has allocated a total of $2,500,000.00 to eligible and selected applicants.
  • Each selected applicant is eligible to receive up to $250,000.00 in funding.
  • The number of recipients for this funding is limited to 10 candidate(s).
  • Eligible applicants include: Small businesses.
Apply for RFA ES 12 004

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Opportunity Summary:

The grant opportunity titled "Novel Technologies for Rapid and Sensitive Biomonitoring in Humans (SBIR R43/R44)" is a National Institutes of Health (NIH) Small Business Innovative Research (SBIR) solicitation aimed at pushing forward new tools for measuring human exposure to environmental chemicals. It is listed as Funding Opportunity Number RFA-ES-12-004 under CFDA 93.113 (Environmental Health) and falls within the environment and health activity category. The core purpose is to support small businesses in developing technologies that can accurately identify and measure a broad range of chemical substances, including known toxicants, suspected toxicants, and the major metabolites that form when those chemicals are processed in the body. The emphasis is on practical biomonitoring solutions that work with real-world human specimens and can be used to strengthen environmental health research, especially studies that connect exposures to health outcomes.

The technical focus of the FOA is the development of point-of-care devices, benchtop instruments, or other laboratory-based methods capable of characterizing major classes of chemical analytes in human biological samples. The announcement specifically highlights matrices such as blood, urine, and saliva, which are among the most common specimen types collected in population-based research. A key detail is that the technologies should be suitable for samples that are likely to be available from both prospective epidemiological cohorts (where samples are collected going forward in time) and retrospective cohorts (where stored samples from earlier collections are analyzed later). That practical constraint matters because cohort studies often have limited specimen volumes, variable storage histories, and the need for methods that can run consistently across many samples.

A central requirement is the ability to detect multiple chemical analytes, not just a single compound, and to do so with high sensitivity and high specificity using low volumes of biological specimens. In biomonitoring, sensitivity is critical because many environmental exposures occur at very low concentrations, yet still may be biologically relevant. Specificity is equally important because biological matrices are complex and contain many molecules that can interfere with measurement, and because misidentifying chemicals or confusing related compounds can lead to incorrect exposure estimates. The FOA therefore encourages technology development that improves multiplexed measurement (multi-analyte detection) while maintaining analytical rigor, enabling more informative exposure profiles from small sample amounts.

From an applicant eligibility standpoint, the opportunity is restricted to small business concerns, consistent with SBIR program rules. The funding instrument is a discretionary grant mechanism using the SBIR R43/R44 structure, which typically corresponds to Phase I (R43) for early feasibility and prototype development and Phase II (R44) for further development and validation toward commercialization and broader deployment. The federal agency listed is NIH, and given the topic area and FOA number, the scientific interest is aligned with environmental health priorities, including improved exposure science and biomarker measurement capabilities that can be used across research and, potentially, clinical or field settings.

In terms of scale and competition, the FOA projected approximately 10 awards with an estimated total funding amount of $2,500,000. The listed award ceiling is $250,000, indicating an upper limit for awards under the terms presented in the source data. There is no cost sharing or matching requirement, which is common for SBIR and removes a barrier for small businesses that may not have substantial non-federal capital at the application stage. The FOA was posted and created on December 15, 2011, with an original and current closing date of February 23, 2012, and it was archived on March 25, 2012, meaning it was a time-limited, past solicitation rather than an open, ongoing opportunity.

Operationally, NIH provided support contacts through the NIH Office of Extramural Research (OER) webmaster addresses for applicants who have trouble accessing the full announcement or linking to it, and it included an additional information link to the NIH grants guide page for RFA-ES-12-004. Overall, the opportunity targeted small businesses capable of building or refining analytical platforms that make human biomonitoring faster, more sensitive, more specific, and more information-rich, particularly in the context of epidemiological research where sample volume and throughput constraints are common and multi-chemical exposure assessment is increasingly important.

Frequently Asked Questions (FAQs)

What is the title of this grant opportunity?

The opportunity is titled "Novel Technologies for Rapid and Sensitive Biomonitoring in Humans (SBIR R43/R44)."

Which agency is offering this opportunity?

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

What is the Funding Opportunity Number (FOA number)?

The FOA is listed as RFA-ES-12-004.

What CFDA program does this fall under?

This opportunity is under CFDA 93.113 (Environmental Health).

What is the main purpose of the solicitation?

The purpose is to support small businesses in developing new tools for measuring human exposure to environmental chemicals, including known toxicants, suspected toxicants, and major metabolites formed when those chemicals are processed in the body.

What kinds of technologies are being sought?

The FOA focuses on developing point-of-care devices, benchtop instruments, or other laboratory-based methods that can characterize major classes of chemical analytes in human biological samples.

What does "biomonitoring" mean in the context of this FOA?

In this FOA, biomonitoring refers to measuring environmental chemicals (and their metabolites) in human specimens to better understand exposure levels and support research linking exposures to health outcomes.

Which human specimen types are specifically highlighted?

The announcement highlights common matrices such as blood, urine, and saliva.

Are the technologies expected to work with real-world samples used in epidemiological research?

Yes. The FOA emphasizes practical biomonitoring solutions that work with real-world human specimens commonly collected in population-based research.

Do the methods need to be suitable for both prospective and retrospective cohort samples?

Yes. The technologies should be suitable for specimens likely to be available from both prospective cohorts (collected going forward) and retrospective cohorts (stored samples analyzed later).

Why does the FOA emphasize prospective and retrospective cohort compatibility?

Cohort studies can involve limited specimen volumes, variable storage histories, and the need for consistent performance across many samples. The FOA highlights these practical constraints as important design considerations.

Is single-chemical detection sufficient for this program?

No. A central requirement is the ability to detect multiple chemical analytes (not just a single compound).

What level of performance is expected for the measurements?

The FOA calls for high sensitivity and high specificity, using low volumes of biological specimens.

Why is high sensitivity important for this opportunity?

Many environmental exposures occur at very low concentrations, yet may still be biologically relevant. The FOA highlights sensitivity as critical for detecting these low-level exposures.

Why is high specificity important for this opportunity?

Biological matrices are complex and can interfere with measurement. Specificity helps avoid misidentifying chemicals or confusing related compounds, which can lead to incorrect exposure estimates.

Does the FOA encourage multiplexed measurement?

Yes. The FOA encourages technology development that improves multiplexed (multi-analyte) measurement while maintaining analytical rigor.

Who is eligible to apply?

Eligibility is restricted to small business concerns, consistent with SBIR program rules.

What funding mechanism is used for this opportunity?

The funding instrument is a discretionary grant mechanism using the SBIR R43/R44 structure.

What do R43 and R44 generally correspond to?

R43 typically corresponds to Phase I (early feasibility and prototype development), and R44 typically corresponds to Phase II (further development and validation toward commercialization and broader deployment).

How many awards were anticipated?

The FOA projected approximately 10 awards.

What was the estimated total funding amount?

The estimated total funding amount listed is $2,500,000.

What is the award ceiling listed for this FOA?

The listed award ceiling is $250,000 (an upper limit for awards under the terms presented in the provided source data).

Is cost sharing or matching required?

No. The FOA indicates there is no cost sharing or matching requirement.

What is the activity category for this opportunity?

It falls within the environment and health activity category.

When was the FOA posted and created?

The FOA was posted and created on December 15, 2011.

What was the closing date for applications?

The original and current closing date listed is February 23, 2012.

Is this an open opportunity right now?

No. The FOA was archived on March 25, 2012, indicating it was a time-limited, past solicitation rather than an open, ongoing opportunity.

Where can applicants find the official NIH information link referenced for this FOA?

The FOA included an additional information link to the NIH grants guide page for RFA-ES-12-004.

Who was listed as a support contact for access issues?

Support contacts were provided through NIH Office of Extramural Research (OER) webmaster addresses for applicants who had trouble accessing the full announcement or linking to it.

What research need is this FOA trying to address?

It targets improved exposure science and biomarker measurement capabilities that can strengthen environmental health research, especially studies that connect chemical exposures to health outcomes.

What kinds of chemical targets are in scope?

The scope includes a broad range of chemical substances: known toxicants, suspected toxicants, and major metabolites produced in the body after exposure.

Does the FOA emphasize speed as well as analytical quality?

Yes. The title and description emphasize rapid biomonitoring paired with high sensitivity and high specificity.

Does the FOA mention limitations common in cohort studies that applicants should consider?

Yes. It notes practical constraints such as limited specimen volumes, variable storage histories, and the need for methods that can run consistently across many samples.

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