Animal Models for Hepatitis B and C (R01 Clinical Trial Not Allowed) | RFA AI 23 022

Opportunity Information: Apply for RFA AI 23 022

The National Institutes of Health (NIH) issued this Funding Opportunity Announcement (FOA), RFA-AI-23-022, titled "Animal Models for Hepatitis B and C (R01 Clinical Trial Not Allowed)," to push the field toward better, more practical research models for hepatitis B virus (HBV) and hepatitis C virus (HCV). The core goal is to develop convenient small animal models that can truly support viral infection and replication, and that can reproduce the two key real-world outcomes seen in people: viral clearance versus long-term persistence. By emphasizing these dichotomous outcomes, the FOA signals strong interest in models that do more than simply allow viral entry or short-lived replication; applicants are expected to build systems that can help investigators study why some hosts eliminate infection while others develop chronic disease.

In addition to straightforward small animal model development, the FOA also welcomes approaches that achieve the same scientific ends through closely related surrogate virus-host systems, as well as xenotransplantation strategies. In practice, this includes robust humanized or xenograft-based models, particularly those designed to be dually engrafted with human liver cells and a human immune system. That dual engraftment emphasis matters because HBV and HCV outcomes are heavily shaped by interactions between infected hepatocytes and immune responses, so models that incorporate both compartments can better capture mechanisms of immune control, immune failure, immunopathology, and pathways to persistence. The overall intent is to expand the toolbox for studying viral life cycles, host responses, and determinants of chronic infection in experimental systems that are accessible enough to be widely used and that more closely mirror clinically relevant biology.

This is an R01 grant mechanism under the NIH, categorized as a discretionary grant in the health activity area (CFDA 93.855). The FOA explicitly states "Clinical Trial Not Allowed," meaning it is aimed at preclinical and mechanistic model development rather than testing interventions in human participants. The announcement was created on March 28, 2023, and listed an original closing date of August 25, 2023. An award ceiling is not specified in the provided source data, and the expected number of awards is also not listed, suggesting applicants would need to consult the full FOA for budget guidance, project period expectations, and any institute- or program-specific limits.

Eligibility is broad and includes many types of domestic applicants: state, county, city or township governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; tribal organizations other than federally recognized tribal governments; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status (other than higher education institutions); for-profit organizations (other than small businesses); and small businesses. The FOA further highlights additional eligible applicants such as Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISIs); Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Tribally Controlled Colleges and Universities (TCCUs); faith-based or community-based organizations; eligible agencies of the federal government; U.S. territories or possessions; regional organizations; and non-domestic (non-U.S.) entities (foreign organizations). This wide eligibility pool indicates NIH is trying to attract diverse teams and capabilities, including institutions that may bring specialized animal model expertise, transplantation platforms, virology capacity, immunology depth, or unique infrastructure.

Taken together, the opportunity is essentially a targeted call to build the next generation of HBV and HCV experimental systems that are easier to use, biologically faithful, and capable of reproducing the critical fork in the road between resolving infection and developing chronic disease. It is meant to enable downstream advances across hepatitis research by giving the field better models for studying viral replication, immune control, persistence, and the host-pathogen dynamics that drive long-term outcomes.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Animal Models for Hepatitis B and C (R01 Clinical Trial Not Allowed)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.855.
• This funding opportunity was created on 2023-03-28.
• Applicants must submit their applications by 2023-08-25. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.

Apply for RFA AI 23 022

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