Novel, Alternative Model Systems for Enteric Diseases (U19) | Apply Online

FAQs: Novel, Alternative Model Systems for Enteric Diseases (U19) - RFA-AI-14-011

What is the purpose of the Novel, Alternative Model Systems for Enteric Diseases (U19) opportunity (RFA-AI-14-011)?

The purpose is to move enteric disease research beyond traditional experimental systems by creating and validating next-generation model platforms that better reflect how intestinal infections and related gut diseases function in humans. The opportunity is designed to support model systems that enable integrated, cross-disciplinary research and that also establish practical groundwork for downstream product development.

What kinds of diseases or research areas does this FOA focus on?

This FOA focuses on enteric diseases, intestinal infections, and related gut diseases, with an emphasis on understanding host-pathogen interactions in the gastrointestinal tract and capturing human-relevant pathophysiology and host responses.

What is the central goal of the program?

The central goal is to create and validate novel model platforms that support integrated, cross-disciplinary research on intestinal infections and related gut diseases, while producing predictive, human-relevant readouts that can be used to evaluate interventions such as vaccines, therapeutics, and diagnostics.

Is this opportunity aimed only at basic science, or also at translation and product development?

It is aimed at both. The FOA supports basic biology questions about gut host-pathogen interactions, and it also emphasizes developing model systems that can generate predictive outcomes useful for evaluating vaccines, therapeutics, diagnostics, and other interventions.

What does the FOA mean by "novel" or "alternative" model systems?

Based on the FOA description, "novel" or "alternative" models are next-generation platforms intended to more closely mimic real human enteric disease biology than simpler in vitro assays or conventional animal models. The FOA highlights advances in biomedical and tissue engineering, including complex human tissue constructs, and leveraging the gastrointestinal microbiome as part of model design.

What are examples of disciplines that applicants are expected to integrate?

The FOA emphasizes team science and integration across fields. Examples of expertise explicitly highlighted include microbiology, immunology, gastroenterology, systems biology, bioengineering, biomaterials, tissue engineering, computational modeling, and microbiome science.

How important is team science and collaboration for this funding opportunity?

Team science is a defining feature. Applicants are expected to assemble collaborative groups that combine disparate scientific fields to build integrated model systems that better capture real disease processes and host responses in the gut.

Does the FOA encourage inclusion of the gastrointestinal microbiome in model design?

Yes. The FOA specifically highlights leveraging the gastrointestinal microbiome as a key component of model design, consistent with the goal of improving biological realism and human relevance.

Are the proposed model systems expected to be more than proof-of-concept?

Yes. The FOA states that supported model systems are expected to be more than proof-of-concept and should be designed to reproduce meaningful features of human enteric disease and deliver relevant, predictive outcomes.

What types of outputs or outcomes are these models expected to produce?

The FOA prioritizes model platforms that provide predictive, human-relevant readouts. It specifically points to models that can distinguish different clinical outcomes or identify severe and potentially lethal sequelae, reflecting interest in understanding variability in disease severity and mechanisms that drive complications beyond the acute infection phase.

Why does the FOA emphasize distinguishing clinical outcomes and severe sequelae?

The FOA signals interest in platforms that can explain why infections may be mild in some contexts but severe in others, and that can illuminate mechanisms behind serious complications that occur after acute infection. Models with this capability may increase confidence that experimental findings map onto human disease.

What funding mechanism is used for this opportunity?

The FOA uses the NIH Cooperative Agreement mechanism, specifically U19.

What does a Cooperative Agreement (U19) imply for NIH involvement?

A cooperative agreement typically indicates substantial NIH scientific and/or programmatic involvement during the project compared with a standard research grant. This aligns with the FOA goal of steering complex, collaborative model-building efforts toward broadly useful outcomes.

Which NIH areas or CFDA numbers are associated with this FOA?

The FOA is associated with CFDA numbers 93.855 and 93.856, reflecting placement within allergy, immunology, microbiology, and infectious diseases research areas.

What was the total estimated funding amount for the announcement?

The total estimated funding for the announcement was $4,500,000.

What was the award ceiling?

The award ceiling listed for the opportunity was $1,500,000.

Was cost sharing or matching required?

No. The FOA states that cost sharing or matching was not required.

What were the key dates for this funding opportunity?

The posted and creation date was January 27, 2014. The application closing date was May 29, 2014. The opportunity was later archived on June 29, 2014.

Is this opportunity still open?

No. The FOA was archived on June 29, 2014, and the application closing date was May 29, 2014.

Who was eligible to apply?

Eligibility was broad across U.S.-based organizations and public or private entities. Eligible applicants included state and local governments, tribal governments and tribal organizations, public housing authorities/Indian housing authorities, special district governments, independent school districts, public and private institutions of higher education, nonprofits with and without 501(c)(3) status (with noted exception categories), small businesses, and for-profit organizations other than small businesses.

Were minority-serving institutions explicitly included in eligibility?

Yes. The FOA explicitly included eligibility for mission-driven institution types such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, tribally controlled colleges and universities, Alaska Native and Native Hawaiian serving institutions, and Asian American Native American Pacific Islander serving institutions, among others.

Could foreign institutions apply as the primary applicant?

No. Foreign institutions (non-U.S. entities) were not eligible to apply as applicant organizations.

Are any international components allowed under this FOA?

Yes. Non-U.S. components of U.S. organizations were eligible, and foreign components as defined by NIH policy were allowed. This suggests certain international collaborations could be supported when the application is anchored by an eligible U.S. applicant organization.

Where could applicants find the full announcement and requirements?

The FOA provided an NIH guide link for the full announcement text and requirements.

Who should be contacted for technical access issues related to the announcement?

The FOA directed technical access issues to the NIH Office of Extramural Research (OER) webmaster contact.

What is the overall emphasis of the program in terms of model design?

The overall emphasis is on improving biological realism and translational relevance by developing models that mimic real pathophysiology and host responses. The FOA highlights advanced biomedical and tissue engineering approaches, complex human tissue constructs, and microbiome-aware model systems as routes to capture disease features missed by simpler assays or conventional animal models.