Opportunity Information: Apply for PAS 19 097
The National Institutes of Health (NIH) funding opportunity announcement (FOA) titled "Research to Advance HBV Cure: HIV/HBV Co-Infection and HBV Mono-infection (R01 Clinical Trial Not Allowed)" (Funding Opportunity Number PAS 19 097; CFDA 93.855) supports research projects aimed at overcoming scientific and medical barriers to curing hepatitis B virus (HBV). The core focus is on innovative basic, translational, and clinical research that can clarify why HBV persists and how cure strategies can be made more effective, both in people living with HBV alone (HBV mono-infection) and in people who have HBV alongside human immunodeficiency virus (HIV/HBV co-infection). The overall intent is to stimulate work that directly tackles the unique challenges HIV can introduce to HBV persistence, immune control, viral reservoirs, and treatment response, while also advancing cure-focused work for HBV more broadly.
The FOA uses the NIH R01 grant mechanism, meaning it is designed for substantial, hypothesis-driven research projects with clearly defined aims and a rigorous scientific approach. Although the announcement allows for clinical research in the sense of studies involving human samples, human data, observational work, or other clinical investigations, it explicitly states "Clinical Trial Not Allowed," which generally means applicants must not propose NIH-defined clinical trials (for example, prospective assignment of human participants to interventions to evaluate effects on health-related outcomes). In practice, that steers applicants toward mechanistic studies, biomarker discovery and validation, studies using clinical cohorts without interventional assignment, translational pipeline work that bridges lab findings to clinically relevant questions, and other non-trial human research that can still be highly patient-centered and clinically meaningful.
This opportunity is categorized as discretionary funding and uses the grant funding instrument, with the activity category listed as health. It is open to a very broad set of applicant organizations, reflecting NIH's interest in bringing many disciplines and institutional types into HBV cure research. Eligible applicants include state, county, and local governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; and federally recognized Native American tribal governments. It also includes public housing authorities and Indian housing authorities, Native American tribal organizations that are not federally recognized tribal governments, and a wide range of nonprofit organizations, including those with and without 501(c)(3) status (as long as they are not institutions of higher education). For-profit organizations (other than small businesses) and small businesses are also eligible, as are other entities not neatly captured by those categories.
The FOA additionally highlights "other eligible applicants" to emphasize inclusion of institutions and organizations that serve specific communities or have particular governance structures. These include 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), and Tribally Controlled Colleges and Universities (TCCUs). It also welcomes faith-based or community-based organizations, eligible agencies of the federal government, Indian/Native American tribal governments other than federally recognized ones, U.S. territories or possessions, and regional organizations. Importantly, non-domestic (non-U.S.) entities, meaning foreign organizations, are explicitly included as eligible, which can be especially relevant for HBV research given the global burden of chronic hepatitis B and the importance of diverse cohorts, viral genotypes, and care settings.
Administratively, the FOA was created on November 29, 2018, and the original closing date listed is January 7, 2020. While the summary information provided does not list an award ceiling, expected awards, or other budgetary specifics, the key takeaway is that it is an NIH R01 opportunity aimed at supporting well-developed research programs rather than small pilot efforts. The emphasis is on advancing the field toward an HBV cure by addressing fundamental and translational questions, including those that are specific to HIV/HBV co-infection, where immune dysfunction, antiretroviral therapy context, and co-morbidity patterns can complicate the path to cure.Apply for PAS 19 097
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Research to Advance HBV Cure: HIV/HBV Co-Infection and HBV Mono-infection (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 2018-11-29.
- Applicants must submit their applications by 2020-01-07. (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.
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Frequently Asked Questions (FAQs)
What is the title of this NIH funding opportunity?
The funding opportunity announcement (FOA) is titled "Research to Advance HBV Cure: HIV/HBV Co-Infection and HBV Mono-infection (R01 Clinical Trial Not Allowed)."
What is the Funding Opportunity Number and CFDA listing?
The Funding Opportunity Number is PAS 19 097, and the CFDA listing is 93.855.
What is the main goal of this FOA?
The goal is to support research that overcomes scientific and medical barriers to curing hepatitis B virus (HBV). The FOA emphasizes work that explains why HBV persists and how cure strategies can be improved.
Which patient populations are the focus of the research?
The FOA focuses on (1) people living with HBV mono-infection (HBV alone) and (2) people living with HIV/HBV co-infection (HBV alongside human immunodeficiency virus, HIV).
Why does this FOA emphasize HIV/HBV co-infection?
The FOA intends to stimulate research that directly addresses the unique challenges HIV can introduce to HBV persistence, immune control, viral reservoirs, and treatment response, while also advancing HBV cure research more broadly.
What types of research does this FOA support?
It supports innovative basic, translational, and clinical research aimed at clarifying mechanisms of HBV persistence and improving cure strategies, including research that is specifically relevant to HIV/HBV co-infection as well as HBV mono-infection.
What does the R01 mechanism imply for the scope of the project?
The FOA uses the NIH R01 mechanism, which is intended for substantial, hypothesis-driven research projects with clearly defined aims and a rigorous scientific approach.
Are clinical trials allowed under this FOA?
No. The FOA explicitly states "Clinical Trial Not Allowed," meaning applicants must not propose NIH-defined clinical trials.
What does "Clinical Trial Not Allowed" mean in practical terms?
It generally means the project must not include prospective assignment of human participants to interventions to evaluate effects on health-related outcomes. The FOA steers applications toward non-trial human research and other approaches that can still be clinically meaningful without being an NIH-defined clinical trial.
If clinical trials are not allowed, can studies involving humans still be included?
Yes. The FOA notes that clinical research can be supported in the sense of studies involving human samples, human data, observational work, clinical investigations that do not meet the NIH definition of a clinical trial, and translational studies that connect laboratory findings to clinically relevant questions.
What are examples of project types that fit this FOA (based on the description provided)?
Examples mentioned or implied in the FOA summary include mechanistic studies, biomarker discovery and validation, studies using clinical cohorts without interventional assignment, and translational pipeline work bridging lab findings to clinically relevant questions.
Is this opportunity focused only on HBV mono-infection research?
No. It explicitly includes both HBV mono-infection and HIV/HBV co-infection, with an emphasis on addressing co-infection-specific challenges while still advancing HBV cure research broadly.
What is the funding instrument and general category for this opportunity?
The opportunity uses the grant funding instrument. It is categorized as discretionary funding, with the activity category listed as health.
Which organizations are eligible to apply?
Eligibility is broad. Eligible applicants include state, county, and local 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; public housing authorities and Indian housing authorities; Native American tribal organizations that are not federally recognized tribal governments; nonprofit organizations with and without 501(c)(3) status (as long as they are not institutions of higher education); for-profit organizations (other than small businesses); small businesses; and other entities not neatly captured by those categories.
Are institutions that serve specific communities explicitly encouraged or listed as eligible?
Yes. The FOA 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), and Tribally Controlled Colleges and Universities (TCCUs).
Are faith-based or community-based organizations eligible to apply?
Yes. Faith-based or community-based organizations are included among the eligible applicant types.
Are federal government entities eligible to apply?
Yes. The FOA includes eligible agencies of the federal government among the eligible applicants.
Are U.S. territories or possessions eligible to apply?
Yes. U.S. territories or possessions are included among the eligible applicants.
Are regional organizations eligible to apply?
Yes. Regional organizations are listed among the eligible applicants.
Are non-U.S. (foreign) organizations eligible to apply?
Yes. The FOA explicitly includes non-domestic (non-U.S.) entities as eligible applicants, which aligns with the global burden of chronic HBV and the value of diverse cohorts, viral genotypes, and care settings.
When was this FOA created?
The FOA was created on November 29, 2018.
What is the original closing date listed for this FOA?
The original closing date listed is January 7, 2020.
Does the provided information include an award ceiling, expected number of awards, or detailed budget limits?
No. The summary information provided does not list an award ceiling, expected awards, or other budgetary specifics.
Based on the description, is this intended for pilot projects or more developed research programs?
Based on the use of the NIH R01 mechanism and the way the opportunity is described, it is aimed at supporting well-developed research programs rather than small pilot efforts.
What kinds of scientific challenges is this FOA trying to address?
It aims to drive progress on fundamental and translational questions related to why HBV persists, how immune control can be achieved or restored, how viral reservoirs may be affected, and why treatment responses may differ, especially in the context of HIV/HBV co-infection where immune dysfunction, antiretroviral therapy context, and co-morbidity patterns can complicate the path to cure.
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