Opportunity Information: Apply for RFA AI 20 057
The National Institutes of Health (NIH) funding opportunity titled "Understanding the Role of the M. Tuberculosis Granuloma in Tuberculosis (TB) Disease and Treatment Outcomes (R01 Clinical Trial Not Allowed)" (Funding Opportunity Number RFA-AI-20-057; CFDA 93.855) is a discretionary grant program designed to support research that clarifies what the tuberculosis granuloma does in real disease settings and how it influences patient outcomes. In pulmonary TB, the granuloma is the signature organized immune structure that forms in the lung around Mycobacterium tuberculosis. It is often described as both protective and problematic: it can help contain infection, but it can also create a niche where bacteria persist, evade immune killing, and respond unevenly to antibiotics. This opportunity aims to deepen the field's understanding of that balance by encouraging studies that define the granuloma's role in disease progression, persistence, and response to treatment, with the long-term purpose of enabling better therapeutic strategies.
At its core, the opportunity emphasizes fundamental and translational research that examines how granulomas form, function, and change over time, and how those changes relate to clinically meaningful outcomes such as bacterial clearance, sterilization, relapse risk, tissue damage, and treatment success or failure. By focusing on the granuloma as a key biological unit of TB pathogenesis, NIH is signaling that improvements in TB therapy may depend not only on discovering new drugs, but also on understanding the microenvironments where drugs and immune cells actually interact with the pathogen. Work supported under this announcement would be expected to generate a stronger mechanistic knowledge base that could guide the design of host-directed therapies, improved drug regimens, or interventions that better penetrate or modulate granulomatous lesions.
The funding mechanism is an R01 research project grant, which typically supports a defined, investigator-driven research plan of several years and is suited to labs or consortia that can take on substantial mechanistic questions. A key boundary is stated directly in the title: "Clinical Trial Not Allowed." That means the program is not intended to fund prospective clinical intervention studies where participants are assigned to receive specific treatments or prevention strategies to evaluate health outcomes. Applicants can still often use clinical samples, observational human data, ex vivo analyses, animal models, advanced imaging, and other approaches that do not meet NIH's definition of a clinical trial, but the research cannot be structured as an interventional clinical trial.
Eligibility is broad and includes many types of organizations, reflecting NIH's intent to draw from a wide research ecosystem. Eligible applicants include state, county, and local governments; special districts; 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/Indian housing authorities; Native American tribal organizations other than federally recognized tribal governments; nonprofit organizations with or without 501(c)(3) status (excluding higher education institutions when specified); for-profit organizations other than small businesses; and small businesses. The announcement also explicitly highlights additional eligible applicant categories, including Alaska Native and Native Hawaiian Serving Institutions; Asian American, Native American, and 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 federal agencies; regional organizations; U.S. territories or possessions; Indian/Native American tribal governments that are not federally recognized; and non-U.S. entities (foreign organizations). This wide eligibility encourages participation from institutions and communities with diverse perspectives, including those in TB-endemic regions outside the United States where granuloma biology and treatment outcomes may be studied in relevant epidemiologic contexts.
From an administrative standpoint, the opportunity was created on September 29, 2020, and the original closing date listed is February 22, 2021. The listing indicates a grant funding instrument type, a health-related funding activity category, and NIH as the sponsoring agency. The award ceiling and expected number of awards are not specified in the provided source information, which typically means applicants would need to consult the full NIH notice and related budget guidance for any limits, expectations, or institute-specific constraints.
In practical terms, this opportunity is aimed at projects that can connect lesion-level biology to outcome-level questions in TB. A competitive application would usually be expected to articulate why granulomas are the critical unit of study for the chosen question, how the proposed methods will capture relevant aspects of granuloma structure and function (for example, cellular composition, spatial organization, metabolic and immune microenvironments, bacterial physiology, or drug distribution), and how findings will advance TB treatment science. The overarching goal is not simply descriptive work, but the kind of mechanistic understanding that can realistically inform improved therapeutic approaches and ultimately better TB disease and treatment outcomes.Apply for RFA AI 20 057
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Understanding the Role of the M. Tuberculosis Granuloma in Tuberculosis (TB) Disease and Treatment Outcomes (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 2020-09-29.
- Applicants must submit their applications by 2021-02-22. (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 is titled "Understanding the Role of the M. Tuberculosis Granuloma in Tuberculosis (TB) Disease and Treatment Outcomes (R01 Clinical Trial Not Allowed)."
What is the Funding Opportunity Number (FON) for this announcement?
The Funding Opportunity Number is RFA-AI-20-057.
What CFDA number is associated with this opportunity?
The CFDA number provided is 93.855.
Which agency is sponsoring this grant program?
The sponsoring agency is the National Institutes of Health (NIH).
What type of funding mechanism is used?
This opportunity uses the R01 research project grant mechanism.
What is the main research focus of this opportunity?
The program supports research to clarify what the tuberculosis granuloma does in real disease settings and how it influences clinically meaningful outcomes, including disease progression, persistence, and response to TB treatment.
Why is the granuloma considered important in pulmonary tuberculosis?
In pulmonary TB, the granuloma is described as the signature organized immune structure in the lung that forms around Mycobacterium tuberculosis. It can help contain infection, but it can also create a niche where bacteria persist, evade immune killing, and respond unevenly to antibiotics.
What kinds of outcomes does NIH want studies to connect to granuloma biology?
The announcement emphasizes linking granuloma-level biology to outcomes such as bacterial clearance, sterilization, relapse risk, tissue damage, and treatment success or failure.
Is this opportunity focused on basic science, translational science, or both?
It emphasizes both fundamental and translational research, particularly work that examines how granulomas form, function, and change over time and how those changes relate to clinically meaningful outcomes.
What is the long-term purpose of funding research on TB granulomas?
The long-term purpose is to enable better therapeutic strategies by building mechanistic knowledge that can guide host-directed therapies, improved drug regimens, or interventions that better penetrate or modulate granulomatous lesions.
Does the funding opportunity allow clinical trials?
No. The title explicitly states "Clinical Trial Not Allowed," meaning the program is not intended to fund prospective clinical intervention studies where participants are assigned to specific treatments or prevention strategies to evaluate health outcomes.
If clinical trials are not allowed, what kinds of human-related research may still fit?
Based on the description, applicants can often use clinical samples, observational human data, and ex vivo analyses, as well as animal models and advanced imaging, as long as the research is not structured as an interventional clinical trial.
What does "Clinical Trial Not Allowed" mean in practical terms for study design?
It means the research cannot be designed as a prospective interventional study that assigns participants to receive specific treatments or prevention strategies to evaluate health outcomes. The work must instead rely on non-interventional approaches consistent with the announcement description.
What kinds of scientific questions are encouraged?
The opportunity encourages mechanistic studies that define the granuloma's role in TB disease progression, bacterial persistence, and response to treatment, including how granulomas change over time and how lesion microenvironments influence bacterial physiology and drug response.
What aspects of granuloma biology are highlighted as relevant to study?
The description highlights capturing relevant aspects of granuloma structure and function such as cellular composition, spatial organization, metabolic and immune microenvironments, bacterial physiology, and drug distribution within lesions.
Is purely descriptive work the goal of this opportunity?
No. The announcement emphasizes that the goal is not simply descriptive work, but mechanistic understanding that can realistically inform improved therapeutic approaches and ultimately better TB disease and treatment outcomes.
How does this opportunity relate to improving TB treatment?
It is framed around the idea that improving TB therapy may require understanding the microenvironments where drugs and immune cells interact with the pathogen, particularly within granulomatous lesions where bacteria may persist and respond unevenly to antibiotics.
Who is eligible to apply?
Eligibility is broad and includes many organization types, including state, county, and local governments; special districts; 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/Indian housing authorities; Native American tribal organizations other than federally recognized tribal governments; nonprofit organizations with or without 501(c)(3) status (excluding higher education institutions when specified); for-profit organizations other than small businesses; and small businesses.
Are institutions serving specific communities explicitly mentioned as eligible?
Yes. The announcement explicitly highlights Alaska Native and Native Hawaiian Serving Institutions; Asian American, Native American, and Pacific Islander Serving Institutions (AANAPISIs); Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Tribally Controlled Colleges and Universities (TCCUs); and faith-based or community-based organizations.
Are federal agencies eligible to apply?
Yes. Eligible applicants include eligible federal agencies.
Are U.S. territories or possessions eligible?
Yes. The announcement includes U.S. territories or possessions among the eligible applicant categories.
Are non-U.S. (foreign) organizations eligible?
Yes. The opportunity states that non-U.S. entities (foreign organizations) are eligible.
Why does the opportunity emphasize broad eligibility, including foreign organizations?
The description notes that this wide eligibility encourages participation from diverse institutions and communities, including those in TB-endemic regions outside the United States where granuloma biology and treatment outcomes may be studied in relevant epidemiologic contexts.
When was this funding opportunity created?
The opportunity was created on September 29, 2020.
What is the original closing date listed for this opportunity?
The original closing date listed is February 22, 2021.
What is the funding instrument type and activity category?
The listing indicates a grant funding instrument type and a health-related funding activity category.
Is there an award ceiling listed?
No. The award ceiling is not specified in the provided information.
Is the expected number of awards provided?
No. The expected number of awards is not specified in the provided information.
What should applicants do if they need information on budget limits or award expectations?
The description indicates that applicants would typically need to consult the full NIH notice and related budget guidance for limits, expectations, or institute-specific constraints, since those details are not included in the provided source information.
What would a competitive application generally be expected to explain?
Based on the description, a competitive application would typically be expected to explain why granulomas are the critical unit of study for the question being asked, how the proposed methods will capture relevant aspects of granuloma structure and function, and how the findings will advance TB treatment science.
What is the overarching goal of the program?
The overarching goal is to generate stronger mechanistic knowledge about the granuloma in TB pathogenesis that can inform improved therapeutic strategies and ultimately improve TB disease and treatment outcomes.
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