Opportunity Information: Apply for RFA ES 15 005

  • The National Institutes of Health in the environment health sector is offering a public funding opportunity titled "Novel Assays for Screening the Effects of Chemical Toxicants on Cell Differentiation (R41)" 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 Jan 27, 2015 and posted on Nov 24, 2014.
  • Applicants must submit their applications by Feb 19, 2015. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
  • The funding agency has allocated a total of $1,000,000.00 to eligible and selected applicants.
  • Each selected applicant is eligible to receive up to $225,000.00 in funding.
  • 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.
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Opportunity Summary:

Novel Assays for Screening the Effects of Chemical Toxicants on Cell Differentiation (R41) is a National Institutes of Health (NIH) Small Business Technology Transfer (STTR) funding opportunity focused on building new laboratory assays that can test how chemical toxicants interfere with stem-cell-driven development. The goal is to support small businesses in developing medium- to high-throughput screening platforms that use pluripotent stem cells or induced pluripotent stem cells (iPSCs) to measure impacts on cell differentiation and on the characteristics of the differentiated cell types that result. A notable emphasis is on assays that could incorporate genetic diversity, since differences among genetic backgrounds can influence toxicological responses and improve the real-world relevance of screening data.

At a practical level, the FOA is looking for assay technologies that can efficiently evaluate many chemicals and conditions, generating data that help explain mechanisms of chemically induced biological activity. These tools are intended to strengthen earlier-stage decision-making in environmental health and toxicology by helping researchers and regulators prioritize which chemicals should move on to more detailed, resource-intensive toxicological evaluation. In addition, the assays are meant to contribute to more predictive models of in vivo biological response, meaning the in vitro results should be informative for how exposures might affect living organisms. By explicitly calling out genetic diversity as useful, the opportunity also points toward test systems that can capture variation across cell lines or donors, supporting insight into differential susceptibility and population-level risk.

This is an STTR Phase I (R41) grant mechanism, meaning it is designed for early-stage feasibility and proof-of-concept work that involves formal collaboration between an eligible small business concern and a research institution partner, as required under STTR rules. The funding instrument type is a grant, and the activity area is Environmental Health under CFDA 93.113. The program does not require cost sharing or matching, which reduces barriers for small businesses developing new assay platforms.

Key funding details include an estimated total program funding level of $1,000,000 and an award ceiling of $225,000 for individual awards under this announcement. The opportunity is listed as discretionary, posted on November 24, 2014, with an original closing date of February 13, 2015 and a current closing date of February 19, 2015. The archive date is March 19, 2015, indicating the solicitation is no longer active, but the description still provides a clear template for what NIH was aiming to stimulate: scalable, mechanistically informative stem-cell differentiation toxicology assays.

Eligibility is limited to United States small business concerns (SBCs). To qualify, an applicant organization must be for-profit, have a place of business in the United States, and operate primarily in the U.S. (or make a significant contribution to the U.S. economy). It must fit an allowed legal structure (such as an LLC, corporation, partnership, sole proprietorship, joint venture, and related forms), meet ownership and control requirements as defined for SBIR/STTR programs, and have no more than 500 employees including affiliates. The announcement lays out specific ownership pathways, including majority ownership by U.S. citizens or permanent resident aliens and certain venture-backed ownership structures (with constraints), as well as requirements for joint ventures.

For additional details, the full announcement was hosted on the NIH grants site under Funding Opportunity Number RFA-ES-15-005, titled exactly as noted. For technical issues accessing the FOA, the contact listed is the NIH Office of Extramural Research (OER) Webmaster at FBOWebmaster@OD.NIH.GOV, which is the support channel referenced for linking or access problems.

Frequently Asked Questions (FAQs)

What is the focus of the "Novel Assays for Screening the Effects of Chemical Toxicants on Cell Differentiation (R41)" opportunity?

This opportunity focuses on developing new laboratory assays that test how chemical toxicants interfere with stem-cell-driven development, particularly how exposures affect cell differentiation and the characteristics of the resulting differentiated cell types.

Which agency and program are sponsoring this funding opportunity?

The opportunity is sponsored by the National Institutes of Health (NIH) under the Small Business Technology Transfer (STTR) program using the Phase I (R41) grant mechanism.

What types of assay platforms are being sought?

The FOA aims to support medium- to high-throughput screening platforms that can efficiently evaluate many chemicals and conditions. The assays should generate data that help explain mechanisms of chemically induced biological activity.

What cell types or model systems does the FOA emphasize?

The announcement emphasizes assay platforms that use pluripotent stem cells or induced pluripotent stem cells (iPSCs) to measure impacts on cell differentiation and on the properties of the differentiated cells that result.

Why is genetic diversity highlighted in this opportunity?

Genetic diversity is emphasized because differences among genetic backgrounds can influence toxicological responses. Assays that incorporate variation across cell lines or donors can improve real-world relevance, support insight into differential susceptibility, and inform population-level risk.

What is the intended use of data produced by these assays?

The data are intended to strengthen earlier-stage decision-making in environmental health and toxicology by helping researchers and regulators prioritize which chemicals should move on to more detailed, resource-intensive toxicological evaluation.

Does the FOA expect assays to relate to real-world biological responses?

Yes. The assays are meant to contribute to more predictive models of in vivo biological response, meaning the in vitro results should be informative for how exposures might affect living organisms.

What grant mechanism is used, and what does it imply about project stage?

This is an STTR Phase I (R41) mechanism, which is designed for early-stage feasibility and proof-of-concept work.

Is collaboration required under this STTR opportunity?

Yes. Because it is an STTR opportunity, it requires formal collaboration between an eligible small business concern and a research institution partner, consistent with STTR rules.

What is the funding instrument type?

The funding instrument is a grant.

What is the activity area and CFDA number associated with this opportunity?

The activity area is Environmental Health, and the CFDA number listed is 93.113.

Is cost sharing or matching required?

No. The announcement indicates that cost sharing or matching is not required.

How much total funding is estimated for the program?

The estimated total program funding level is $1,000,000.

What is the maximum award amount (award ceiling) for an individual award?

The award ceiling for individual awards under this announcement is $225,000.

Is this opportunity mandatory or discretionary?

The opportunity is listed as discretionary.

When was this opportunity posted?

The opportunity was posted on November 24, 2014.

What were the closing dates listed for this opportunity?

The original closing date was February 13, 2015, and the current closing date was February 19, 2015.

Is the solicitation still active?

No. The archive date is March 19, 2015, indicating the solicitation is no longer active.

Who is eligible to apply?

Eligibility is limited to United States small business concerns (SBCs).

What basic organizational requirements must an applicant meet to qualify as an eligible SBC?

The applicant must be for-profit, have a place of business in the United States, and operate primarily in the U.S. (or make a significant contribution to the U.S. economy).

What types of legal structures are allowed for applicant small businesses?

Allowed legal structures include entities such as an LLC, corporation, partnership, sole proprietorship, joint venture, and related forms, as described for SBIR/STTR programs.

Is there an employee size limit for eligibility?

Yes. The small business must have no more than 500 employees, including affiliates.

Are there specific ownership and control requirements?

Yes. The announcement references SBIR/STTR-defined ownership and control requirements, including majority ownership by U.S. citizens or permanent resident aliens and certain venture-backed ownership structures (with constraints), as well as requirements for joint ventures.

What is the Funding Opportunity Number for this announcement?

The NIH Funding Opportunity Number is RFA-ES-15-005.

Where was the full announcement hosted?

The full announcement was hosted on the NIH grants site under the listed funding opportunity number.

Who should be contacted for technical issues accessing the FOA?

For technical issues related to accessing the FOA (such as linking or access problems), the contact listed is the NIH Office of Extramural Research (OER) Webmaster at FBOWebmaster@OD.NIH.GOV.

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