Opportunity Information: Apply for RFA ES 14 005

  • 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 (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 May 9, 2014 and posted on May 9, 2014.
  • Applicants must submit their applications by Aug 15, 2014. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
  • The funding agency has allocated a total of $3,000,000.00 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 applications for this opportunity. A small business concern is one that, at the time of award of 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 must be less than 50 percent participation by foreign business entities in the joint venture 3. (i) SBIR and STTR. Be a concern which is more than 50 directly owned and controlled by one or more individuals (who are citizens or permanent resident aliens of the United States), other business concerns (each of which is more than 50 directly owned and controlled by individuals who are citizens or permanent resident aliens of the United States), or any combination of these OR (ii) SBIR only. Be a concern which is more than 50 owned by multiple venture capital operating companies, hedge funds, private equity firms, or any combination of these. No single venture capital operating company, hedge fund, or private equity firm may own more than 50 of the concern OR (iii) SBIR and STTR. Be a joint venture in which each entity to the joint venture must meet the requirements set forth in paragraph 3 (i) or 3 (ii) of this section. A joint venture that includes one or more concerns that meet the requirements of paragraph (ii) of this section must comply with 121.705(b) concerning registration and proposal requirements. 4. Has, including its affiliates, not more than 500 employees. If the concern is more than 50 owned by multiple venture capital operating companies, hedge funds, private equity firms, or any combination of these falls under 3 (ii) or 3 (iii) above, see Section IV. Application and Submission Information for additional instructions regarding required application certification.
Apply for RFA ES 14 005

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Opportunity Summary:

The grant opportunity titled "Novel Technologies for Rapid and Sensitive Biomonitoring in Humans (R43/R44)" (Funding Opportunity Number RFA-ES-14-005) is a National Institutes of Health (NIH) Small Business Innovative Research (SBIR) solicitation focused on advancing practical tools for human biomonitoring. At its core, the announcement is looking for technology development that makes it easier, faster, and more sensitive to measure chemical exposures in people by detecting toxicants (both known and suspected) and their major metabolites directly in human biological specimens. The FOA emphasizes platforms that can work with real-world sample types commonly collected in research and clinical settings, specifically blood, urine, and saliva, and it highlights the need to function well with the kinds of samples that exist in large epidemiological studies, including both prospective cohorts (samples collected going forward) and retrospective cohorts (samples stored from past collection).

A defining theme of the solicitation is multiplexed detection: applicants are expected to build methods or instruments that can measure multiple chemical analytes at once rather than focusing on a single compound. NIH is explicitly prioritizing high sensitivity and high specificity in low volumes of biological material, which reflects common constraints in cohort studies where sample volumes can be limited and precious. In practical terms, this means the technologies should be capable of producing reliable exposure measurements even when only small aliquots are available, while still distinguishing target analytes from confounders and background noise in complex biological matrices.

From a technology standpoint, the FOA is broad in what it will consider as long as the end result improves biomonitoring capability. It invites proposals for point-of-care instruments, benchtop systems, and other laboratory-based approaches. This flexibility suggests NIH is open to a range of engineering and analytical chemistry solutions, including compact devices intended for near-patient or near-field use, as well as laboratory workflows that could be adopted by analytical labs supporting population studies. What matters most is that the approach materially advances the ability to characterize major classes of relevant analytes in human samples with strong performance characteristics (speed, sensitivity, specificity, and multi-analyte capability), and that it is realistic for the kinds of specimen types and conditions encountered in epidemiologic research.

The funding mechanism is SBIR under the R43/R44 activity codes, meaning it supports the typical SBIR phased development pathway. Phase I (R43) generally supports early feasibility and proof-of-concept work, while Phase II (R44) supports further research and development toward a more complete prototype, validation, and readiness for commercialization or broader deployment. The fact that this is an R43/R44 FOA signals that NIH wants small businesses to move beyond basic research and toward tangible tools that can be used by researchers and, potentially, clinical or public health entities for exposure assessment.

Eligibility is limited to United States small business concerns, and the FOA spells out the standard SBIR requirements in detail. The applicant must be a for-profit entity with a place of business in the United States and must operate primarily in the United States or contribute significantly to the US economy through taxes or use of US products, materials, or labor. The company must fit an acceptable legal structure (for example, LLC, corporation, partnership, sole proprietorship, joint venture, and similar forms). Size eligibility is capped at not more than 500 employees, including affiliates. Ownership and control rules follow SBIR policy, including the pathways for majority ownership by US citizens or permanent resident aliens, as well as SBIR-allowed majority ownership by multiple venture capital operating companies, hedge funds, or private equity firms under specified constraints (including that no single such entity may own more than 50 percent). Joint venture applicants are permitted as long as each participating entity meets the relevant SBIR ownership requirements, and special registration and proposal requirements apply in some venture-backed joint venture scenarios.

Administratively, the opportunity is categorized as discretionary grant funding within the Environment and Health funding activity area (CFDA 93.113 Environmental Health). The announcement indicates there is no cost sharing or matching requirement, which is typical for SBIR. The total estimated funding level listed is $3,000,000. The FOA was posted on May 9, 2014, with an original and current closing date of August 15, 2014, and an archive date of September 15, 2014, indicating this specific solicitation cycle is historical rather than currently open. The sponsor agency is NIH, and the full announcement was hosted through the NIH grants guide at the provided link.

Overall, this FOA is best understood as a targeted push to modernize and expand the toolkit for measuring chemical exposures in humans at scale. By emphasizing multi-analyte detection, strong analytical performance, and compatibility with small sample volumes from cohort studies, NIH is signaling that it wants enabling technologies that can strengthen environmental health research and exposure science. The ideal outcome of funded projects would be practical biomonitoring platforms that allow researchers to detect and quantify a wider range of toxicants and metabolites more efficiently, supporting better links between exposure and health outcomes in population-based studies.

Frequently Asked Questions (FAQs)

What is the title and funding opportunity number for this grant?

The opportunity is titled "Novel Technologies for Rapid and Sensitive Biomonitoring in Humans (R43/R44)" and the Funding Opportunity Number is RFA-ES-14-005.

Which agency is sponsoring this opportunity?

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

What type of funding mechanism is being used?

This is an NIH Small Business Innovative Research (SBIR) solicitation using the R43/R44 activity codes.

What do R43 and R44 mean in this solicitation?

R43 generally refers to SBIR Phase I, which supports early feasibility and proof-of-concept work. R44 generally refers to SBIR Phase II, which supports further research and development toward a more complete prototype, validation, and readiness for commercialization or broader deployment.

What is the overall purpose of this funding opportunity?

The FOA focuses on developing practical tools for human biomonitoring that make it easier, faster, and more sensitive to measure chemical exposures in people by detecting toxicants (known and suspected) and their major metabolites directly in human biological specimens.

What kinds of samples should the proposed technologies work with?

The FOA emphasizes technologies that work with real-world sample types commonly collected in research and clinical settings, specifically blood, urine, and saliva.

Does the FOA prioritize technologies that can be used in epidemiological cohort studies?

Yes. It highlights the need to function well with the kinds of samples that exist in large epidemiological studies, including both prospective cohorts (samples collected going forward) and retrospective cohorts (samples stored from past collection).

What does the FOA mean by "multiplexed detection"?

Multiplexed detection means the ability to measure multiple chemical analytes at once, rather than focusing on a single compound. The FOA identifies this as a defining theme and expects applicants to build multi-analyte measurement methods or instruments.

Is high sensitivity and specificity required?

Yes. NIH explicitly prioritizes high sensitivity and high specificity, particularly in low volumes of biological material, so that technologies can produce reliable exposure measurements and distinguish target analytes from confounders and background noise in complex biological matrices.

Why does the FOA emphasize low sample volumes?

The FOA notes that cohort studies often have limited and precious sample volumes. Technologies are expected to perform well even when only small aliquots are available.

What types of technology platforms are eligible or encouraged?

The FOA is broad and invites proposals for point-of-care instruments, benchtop systems, and other laboratory-based approaches, as long as the end result improves biomonitoring capability.

Is the FOA limited to point-of-care devices?

No. While point-of-care instruments are invited, the FOA also welcomes benchtop and other laboratory-based systems and workflows that could be adopted by analytical labs supporting population studies.

What performance characteristics are emphasized for proposed technologies?

The FOA emphasizes speed, sensitivity, specificity, and multi-analyte capability, along with realistic compatibility with specimen types and conditions encountered in epidemiologic research.

Who is eligible to apply?

Eligibility is limited to United States small business concerns that meet standard SBIR requirements.

What are the basic organizational requirements for the applicant business?

The applicant must be a for-profit entity with a place of business in the United States and must operate primarily in the United States or contribute significantly to the US economy through taxes or use of US products, materials, or labor.

Are there restrictions on the company size?

Yes. Size eligibility is capped at not more than 500 employees, including affiliates.

What legal business structures are acceptable under this FOA?

The FOA indicates the company must fit an acceptable legal structure such as an LLC, corporation, partnership, sole proprietorship, joint venture, and similar forms.

How do SBIR ownership and control rules factor into eligibility?

Ownership and control rules follow SBIR policy, including majority ownership by US citizens or permanent resident aliens, and SBIR-allowed majority ownership by multiple venture capital operating companies, hedge funds, or private equity firms under specified constraints.

Does the FOA allow venture-backed majority ownership?

Yes. The FOA describes SBIR-allowed majority ownership by multiple venture capital operating companies, hedge funds, or private equity firms, with specified constraints, including that no single such entity may own more than 50 percent.

Are joint ventures allowed to apply?

Yes. Joint venture applicants are permitted as long as each participating entity meets the relevant SBIR ownership requirements. The FOA also notes that special registration and proposal requirements apply in some venture-backed joint venture scenarios.

What is the CFDA listing and funding activity area for this opportunity?

The opportunity is categorized under the Environment and Health funding activity area and is associated with CFDA 93.113 Environmental Health.

Is this considered discretionary grant funding?

Yes. The opportunity is categorized as discretionary grant funding.

Is cost sharing or matching required?

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

What is the estimated total funding level mentioned in the FOA?

The total estimated funding level listed is $3,000,000.

When was this FOA posted, and what were the key dates?

The FOA was posted on May 9, 2014. The original and current closing date listed is August 15, 2014, and the archive date is September 15, 2014.

Is this opportunity currently open?

No. Based on the listed closing and archive dates, this specific solicitation cycle is historical rather than currently open.

What is NIH trying to achieve by funding projects under this FOA?

The FOA is positioned as a targeted push to modernize and expand the toolkit for measuring chemical exposures in humans at scale, strengthening environmental health research and exposure science by improving multi-analyte detection, analytical performance, and compatibility with cohort study samples.

What is the ideal outcome of projects funded under this FOA?

The ideal outcome is practical biomonitoring platforms that allow researchers to detect and quantify a wider range of toxicants and metabolites more efficiently, supporting stronger links between exposure and health outcomes in population-based studies.

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