Intramural - Extramural Collaboration for Drug Screening with Biofabricated 3-D Disease Tissue Models (UH2/UH3 Clinical Trial Not Allowed) | RFA TR 21 015

Frequently Asked Questions (FAQs)

What is the title of this NIH funding opportunity?

The funding opportunity is titled "Intramural - Extramural Collaboration for Drug Screening with Biofabricated 3-D Disease Tissue Models (UH2/UH3 Clinical Trial Not Allowed)." It is identified as RFA-TR-21-015 and is associated with CFDA 93.350.

What is the main goal of this opportunity?

The central goal is to bring together NIH intramural scientists at the NCATS 3-D Bioprinting Laboratory and domestic extramural researchers to jointly create and validate biofabricated 3-D human disease tissue models. These models are intended to support disease research and improve drug screening by providing more realistic and predictive systems than traditional 2-D cell culture.

Who are the intended collaborators on a project?

Projects are intended to be collaborative efforts between two groups: (1) intramural scientists at the NCATS 3-D Bioprinting Laboratory and (2) eligible extramural investigators and organizations based outside the NIH (for example, universities, nonprofits, companies, and other eligible U.S. organizations).

What does "Intramural - Extramural Collaboration" mean in practice?

It means the funded work is expected to be conducted through close coordination between an NIH intramural group (NCATS 3-D Bioprinting Laboratory) and an extramural awardee. The program is designed for teams that jointly develop and validate 3-D biofabricated disease tissue models for drug screening and translational research use.

What is the funding mechanism for this FOA?

The award uses a cooperative agreement mechanism (UH2/UH3). A cooperative agreement indicates substantial scientific involvement from NIH and an expectation of active collaboration and coordination with the NCATS intramural bioprinting team.

What does the UH2/UH3 structure imply about the project timeline and expectations?

The UH2/UH3 structure typically reflects a staged approach: an initial phase focused on development and feasibility (UH2), followed by a second phase focused on broader demonstration, validation, and use (UH3). Based on the FOA description, projects are expected to progress beyond building a tissue construct and provide convincing evidence the model works for disease modeling and drug screening.

What kinds of scientific activities are within scope?

The scientific scope centers on 3-D biofabrication and bioprinting-based tissue engineering for drug screening. Activities described as within scope include designing tissue architectures, selecting cell sources and biomaterials, establishing functional assays, and demonstrating drug response testing using the engineered tissues.

What types of assays or readouts are mentioned as examples?

Examples of functional assays/readouts include viability, barrier integrity, contractility, electrophysiology, secretion of biomarkers, and other disease-relevant phenotypes. The FOA emphasizes measurable and reproducible endpoints that matter for drug discovery and translational research.

Does the FOA prioritize disease models over healthy tissue models?

Yes. The emphasis on "disease tissue models" indicates NIH is looking for models that represent specific disease states or pathological processes, rather than only generic healthy tissue models.

What does "drug screening" imply for model development?

It suggests attention to practical screening needs such as robustness, reproducibility, assay performance, and workflows that can support compound testing. The FOA description indicates the program is not focused on a one-off proof-of-concept alone, but on models that can be used credibly for drug response testing.

Are clinical trials allowed under this opportunity?

No. The FOA is explicitly "Clinical Trial Not Allowed." Applicants must propose preclinical and laboratory-based research and should not propose studies that prospectively assign human participants to interventions to evaluate health outcomes.

If clinical trials are not allowed, what type of work is expected?

The expected work is preclinical and laboratory-based research aimed at improving translational tools and screening platforms, specifically biofabricated 3-D human disease tissue models for drug screening and disease research.

Which NIH entity is associated with the intramural collaboration?

The intramural partner referenced in the FOA is the NCATS 3-D Bioprinting Laboratory (NCATS is the National Center for Advancing Translational Sciences).

Who can apply (what types of organizations are eligible)?

Eligibility is broad for U.S.-based organizations and includes: state, county, and local governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; nonprofits (501(c)(3) and non-501(c)(3)); public housing authorities/Indian housing authorities; federally recognized tribal governments and other tribal organizations; for-profit entities other than small businesses; and small businesses.

Are there additional applicant types specifically called out as eligible?

Yes. The FOA also calls out eligibility for Alaska Native and Native Hawaiian Serving Institutions, AANAPISIs, Hispanic-serving institutions, HBCUs, tribally controlled colleges and universities, eligible federal agencies, faith-based or community-based organizations, regional organizations, and U.S. territories or possessions.

Are foreign organizations eligible to apply?

No. The FOA draws a firm line against foreign participation: non-U.S. entities are not eligible to apply.

Can a U.S. organization include a non-U.S. component?

No. The FOA states that non-U.S. components of U.S. organizations are not eligible and that foreign components (as defined by NIH policy) are not allowed.

What is the role of NIH in a cooperative agreement for this program?

The cooperative agreement mechanism indicates NIH expects substantial scientific involvement and close coordination. In this FOA, that involvement is tied directly to partnering with the NCATS intramural 3-D bioprinting group to jointly develop and validate the tissue models.

Does the FOA require validation and demonstration, not just model construction?

Yes. The description emphasizes that projects should not stop at building a tissue construct. They should also show convincing evidence that the model can be used for disease modeling and drug screening in ways that are meaningful to the research community, including reproducible readouts and support for compound testing workflows.

What is the publishing agency and when was the opportunity created?

The opportunity was published by the National Institutes of Health (NIH) and was created on April 2, 2021.

What was the original closing date for this opportunity?

The original closing date was June 28, 2021.

Is award size, ceiling, or number of awards provided in the information above?

No. The provided information does not include an award ceiling or the expected number of awards.

What is the overall intended outcome of the program?

The intended outcome is to fund collaborative, milestone-driven efforts that produce credible biofabricated 3-D human disease tissue models and demonstrate their practical value for drug screening and disease research through a close intramural-extramural partnership with the NCATS 3-D Bioprinting Laboratory.