Opportunity Information: Apply for PA 13 223
Apply for PA 13 223
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Improvement of Animal Models and Development of Technologies for Stem Cell Based Regenerative Medicine (SBIR)(R43/R44)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.286 Discovery and Applied Research for Technological Innovations to Improve Human Health 93.351 Research Infrastructure Programs 93.859 Biomedical Research and Research Training.
- This funding opportunity was created on May 8, 2013 and posted on May 8, 2013.
- Applicants must submit their applications by May 7, 2016. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Eligible applicants include: Small businesses.
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Opportunity Summary:
The grant opportunity titled "Improvement of Animal Models and Development of Technologies for Stem Cell Based Regenerative Medicine (SBIR) (R43/R44)" is a National Institutes of Health (NIH) Funding Opportunity Announcement (FOA) aimed specifically at small business concerns through the Small Business Innovation Research (SBIR) program. It supports early stage and follow on small business R and D (Phase I and Phase II under the R43 and R44 mechanisms) that can lead to commercial products and enabling technologies for regenerative medicine. The central idea is to strengthen the tools and model systems needed to evaluate stem cell based therapies before they ever reach human trials, with a strong emphasis on practical, testable, and product oriented deliverables that improve preclinical decision making.
The scientific focus is on developing or improving methods to obtain, characterize, and test stem cells and their derivatives from both animal and human sources, then applying those advances to animal models that better predict how regenerative medicine therapies will behave in people. The FOA is essentially trying to close a persistent gap in the field: stem cell therapies often look promising in simplified or poorly matched animal studies, but later fail due to safety issues, lack of efficacy, or differences between animal and human biology. By funding the creation of more informative animal models and better stem cell technologies, NIH is encouraging small companies to build the kinds of robust preclinical platforms that can reliably assess safety, mechanism of action, dosing, delivery, engraftment, and functional outcomes.
The announcement highlights three major areas of interest. First is comparative analysis of animal and human stem cells. This includes side by side studies that clarify how stem cells from different species compare in terms of key properties such as differentiation capacity, maturation, stability, immunogenicity, and functional behavior in vivo. The practical goal is to help the field select animal systems that are most predictive and informative for specific therapeutic applications, rather than defaulting to traditional models that may not translate well. Projects in this area might generate data, assays, or standardized benchmarks that allow researchers and developers to choose the right species, cell type, and experimental context for a given regenerative medicine question.
Second is the development of new technologies for stem cells and their derivatives, spanning production, characterization, and transplantation. This area is broad and intentionally geared toward tool and platform development, such as improved methods for generating clinically relevant cell populations, scaling production, enhancing quality control, and verifying identity and potency. It also includes technologies that make transplantation studies more reliable, for example better cell delivery approaches, tracking and imaging tools to follow cell fate after administration, or assays that detect unwanted outcomes like aberrant differentiation, tumor formation, or immune complications. The emphasis is on enabling technologies that reduce uncertainty and increase reproducibility when evaluating stem cell products in preclinical settings.
Third is the improvement of animal disease models for stem cell based therapeutic applications. Here, the FOA is looking for more realistic and informative models of human disease and injury that are suitable for testing stem cell derived therapies. That can involve refining existing models to better mimic human pathology, developing new models that capture clinically meaningful endpoints, or creating models where safety concerns and therapeutic effects can be evaluated in a way that mirrors intended clinical use. The purpose is not simply to create an animal model for its own sake, but to produce models that help answer the specific translational questions that regulators, clinicians, and developers face when moving a stem cell based product toward the clinic.
Across all three areas, the stated outcome is commercial impact: the ultimate objective is to produce marketable products and technologies that accelerate the development of future clinical therapies. In practical terms, NIH is signaling that successful proposals should be built around a clear product concept, a defined customer or end user (for example, regenerative medicine companies, academic labs, CROs, or translational research centers), and a development pathway that fits the SBIR model. The funded work is intended to be directly useful for preclinical evaluation, meaning the work should help generate data that supports safety and therapeutic potential and should improve the reliability of preclinical testing.
From an administrative standpoint, this is a discretionary grant opportunity offered by NIH, with no cost sharing or matching requirement, and eligibility limited to small businesses. The Funding Opportunity Number is PA-13-223, it was posted May 8, 2013, and it originally closed May 7, 2016 (with an archive date of June 7, 2016). The program is associated with CFDA listings 93.286 (Discovery and Applied Research for Technological Innovations to Improve Human Health), 93.351 (Research Infrastructure Programs), and 93.859 (Biomedical Research and Research Training), reflecting its alignment with translational technology development and biomedical research infrastructure. The full announcement was hosted through the NIH grants guide, and NIH provided contact support through the NIH Office of Extramural Research (OER) webmaster for access or linking issues.
Frequently Asked Questions (FAQs)
What is the title of this grant opportunity?
The opportunity is titled "Improvement of Animal Models and Development of Technologies for Stem Cell Based Regenerative Medicine (SBIR) (R43/R44)."
Which agency is offering this funding opportunity?
This is a National Institutes of Health (NIH) Funding Opportunity Announcement (FOA).
What is the funding opportunity number (FOA number)?
The Funding Opportunity Number is PA-13-223.
Which funding program does this FOA use?
The FOA is offered through the Small Business Innovation Research (SBIR) program.
Who is eligible to apply?
Eligibility is limited to small business concerns (small businesses), consistent with SBIR requirements.
What award mechanisms are supported?
The FOA supports SBIR Phase I and Phase II research and development through the R43 and R44 mechanisms.
What types of projects is NIH trying to fund through this FOA?
The FOA supports early-stage and follow-on small business R&D projects that can lead to commercial products and enabling technologies for regenerative medicine, with a strong focus on practical, testable, product-oriented deliverables that improve preclinical decision-making.
What is the main goal or central idea of the FOA?
The main goal is to strengthen the tools and model systems used to evaluate stem cell-based therapies before they reach human trials, so preclinical testing can better predict safety, efficacy, and translational performance in people.
Why does NIH emphasize improved animal models and stem cell technologies?
The FOA is aimed at closing a persistent gap in regenerative medicine: stem cell therapies may appear promising in simplified or poorly matched animal studies, then later fail due to safety issues, lack of efficacy, or animal-human biological differences. NIH is encouraging development of more informative models and tools to reduce those translational failures.
What kinds of stem cells are within scope for this FOA?
The FOA focuses on stem cells and their derivatives from both animal and human sources, including methods to obtain, characterize, and test them, and then apply those advances in animal models relevant to regenerative medicine therapies.
What kinds of preclinical questions should funded projects help address?
Projects are intended to improve the reliability of preclinical evaluation, including generating data and capabilities relevant to safety, mechanism of action, dosing, delivery, engraftment, and functional outcomes.
What are the three major scientific areas of interest in this FOA?
The FOA highlights three areas: (1) comparative analysis of animal and human stem cells, (2) development of new technologies for stem cells and their derivatives, and (3) improvement of animal disease models for stem cell-based therapeutic applications.
What does "comparative analysis of animal and human stem cells" mean in this FOA?
It refers to side-by-side studies comparing stem cells from different species to clarify key properties such as differentiation capacity, maturation, stability, immunogenicity, and functional behavior in vivo, with the practical goal of helping developers choose animal systems that are most predictive for specific therapeutic applications.
What kinds of outputs might be expected from comparative stem cell analysis projects?
Based on the FOA description, these projects might generate data, assays, or standardized benchmarks that help researchers select the right species, cell type, and experimental context for a particular regenerative medicine question.
What does the FOA mean by "development of new technologies for stem cells and their derivatives"?
This area spans production, characterization, and transplantation-related technologies. It includes tools and platforms for generating clinically relevant cell populations, scaling production, improving quality control, and verifying identity and potency.
Does this FOA support technologies related to transplantation and in vivo studies?
Yes. The FOA includes technologies that make transplantation studies more reliable, such as improved delivery approaches, tracking and imaging tools to follow cell fate after administration, and assays to detect unwanted outcomes.
What kinds of safety-related issues are specifically mentioned as targets for detection or evaluation?
The FOA mentions unwanted outcomes like aberrant differentiation, tumor formation, and immune complications as examples of issues that improved assays and technologies could help detect in preclinical studies.
What does the FOA mean by "improvement of animal disease models" for stem cell therapies?
It means creating or refining animal models to be more realistic and informative for testing stem cell-derived therapies, including refining existing models to better mimic human pathology, developing new models, and focusing on clinically meaningful endpoints relevant to intended clinical use.
Is the FOA interested in animal models "for their own sake"?
No. The FOA states the purpose is not simply to create an animal model, but to produce models that answer translational questions that regulators, clinicians, and developers face when moving a stem cell-based product toward the clinic.
How important is commercialization in this FOA?
Commercial impact is a stated outcome across the areas of interest. The FOA emphasizes marketable products and technologies that accelerate development of future clinical therapies, and signals that proposals should reflect a clear product concept, a defined customer or end user, and a development pathway aligned with the SBIR model.
Who are examples of intended customers or end users mentioned in the FOA?
The FOA provides examples such as regenerative medicine companies, academic labs, contract research organizations (CROs), and translational research centers.
Does this opportunity require cost sharing or matching funds?
No. The FOA indicates there is no cost sharing or matching requirement.
When was this FOA posted, and what is its status now?
The FOA was posted on May 8, 2013. It originally closed on May 7, 2016, with an archive date of June 7, 2016.
Which CFDA listings are associated with this FOA?
The FOA is associated with CFDA listings 93.286, 93.351, and 93.859.
What do the listed CFDAs indicate about the focus of this program?
Based on the FOA description, the associated CFDA listings reflect alignment with discovery and applied research for technological innovations to improve human health, research infrastructure programs, and biomedical research and research training.
Where was the full announcement hosted?
The full announcement was hosted through the NIH grants guide.
Who was listed as a contact for access or linking issues?
NIH provided contact support through the NIH Office of Extramural Research (OER) webmaster for access or linking issues.
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