Opportunity Information: Apply for PAR 21 304
The Brazil Regional Prospective Observational Research in Tuberculosis (RePORT) opportunity (Funding Opportunity Number PAR 21 304) is a National Institutes of Health (NIH) discretionary funding announcement that uses a cooperative agreement mechanism (U01) to build and support a Brazil-US regional network focused on prospective, observational tuberculosis research. The core idea is to take advantage of Brazils established clinical research capacity and infrastructure to generate high-quality, standardized data and specimens that can deepen understanding of what drives different TB outcomes. The FOA is explicitly labeled "Clinical Trial Not Allowed," meaning projects supported under this announcement should be observational in nature rather than testing interventions, assigning treatments, or otherwise conducting clinical trials.
Scientifically, the network is meant to study how community-level conditions, host biology, and microbial factors influence the course and outcomes of TB infection and TB disease. A major emphasis is placed on tuberculosis among persons with HIV (PWH), reflecting the especially high burden and complexity of TB/HIV co-infection. The scope also includes drug-resistant TB, with the intention of improving knowledge about why some patients respond well to therapy while others relapse, fail treatment, or experience poor outcomes. By clarifying these drivers, the program aims to accelerate development of practical tools that can improve treatment outcomes for individual patients (for example, better predictors of risk, disease progression, or treatment response) and also inform larger public health strategies to reduce transmission and curb the broader TB epidemic.
From an organizational standpoint, this is designed as a networked effort rather than a single stand-alone study. In practice, a RePORT network typically implies harmonized protocols, common data elements, coordinated approaches to enrollment and follow-up, and the ability to combine information across sites. The expected end product is a stronger platform for longitudinal observational research in Brazil that is closely linked with US collaborators, enabling questions to be addressed at scale and with consistent methods. Because it is a cooperative agreement, NIH is expected to have substantial involvement, which often includes coordination expectations, shared governance structures, and regular interaction between awardees and the funding institute to ensure the network meets program goals.
Eligibility is broad and includes many types of US-based and non-US entities. Eligible applicants listed 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; other Native American tribal organizations; public housing authorities/Indian housing authorities; nonprofits with and without 501(c)(3) status (excluding institutions of higher education in those nonprofit categories); for-profit organizations other than small businesses; small businesses; and other organizations. The announcement also highlights additional eligible applicant groups such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISI), 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, non-domestic (non-US) entities/foreign organizations, Indian/Native American tribal governments that are not federally recognized, and US territories or possessions. This breadth signals NIH interest in drawing on a wide range of institutions capable of supporting international, multi-site observational TB research and the data management, laboratory, and partnership capabilities that come with it.
Key administrative details from the source data include the agency (National Institutes of Health), the program classification (CFDA 93.855), and the funding instrument (cooperative agreement). The original closing date listed is 2021-12-08, and the opportunity creation date is 2021-08-05. The award ceiling is shown as 700,000 (typically interpreted as an annual maximum per award unless otherwise specified in the full FOA), while the expected number of awards is not provided in the excerpt. Overall, the opportunity is best understood as a structured effort to create or strengthen a Brazil-US observational TB research network that can produce actionable epidemiologic, clinical, immunologic, and microbiologic insights, especially for TB in people living with HIV and for drug-resistant disease, without conducting interventional clinical trials.Apply for PAR 21 304
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Brazil Regional Prospective Observational Research in Tuberculosis (RePORT) (U01 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 2021-08-05.
- Applicants must submit their applications by 2021-12-08. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Each selected applicant is eligible to receive up to $700,000.00 in funding.
- 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 Brazil Regional Prospective Observational Research in Tuberculosis (RePORT) opportunity?
It is a National Institutes of Health (NIH) discretionary funding announcement designed to build and support a Brazil-US regional network for prospective, observational tuberculosis (TB) research. The goal is to generate high-quality, standardized data and specimens that help explain why TB outcomes differ across people and settings.
What is the Funding Opportunity Number (FOA number)?
The Funding Opportunity Number is PAR 21 304.
What funding mechanism is used for this opportunity?
This opportunity uses a cooperative agreement mechanism (U01). A cooperative agreement generally means NIH expects to have substantial involvement in the funded project, often through coordination, shared governance, and regular interactions to ensure the network meets program goals.
Is this opportunity intended for clinical trials?
No. The announcement is explicitly labeled "Clinical Trial Not Allowed." Projects supported under this opportunity should be observational in nature and should not test interventions, assign treatments, or otherwise conduct clinical trials.
What type of research is supported (observational vs. interventional)?
The emphasis is on prospective, longitudinal observational research. The network is intended to follow participants over time, collect standardized information, and support analyses that improve understanding of TB infection and TB disease outcomes without intervening in clinical care as part of a trial.
What is the main purpose of creating a Brazil-US RePORT network?
The purpose is to leverage Brazil's established clinical research capacity and infrastructure, while partnering closely with US collaborators, to produce harmonized, high-quality datasets and specimens. This networked approach is meant to enable larger-scale, consistent, multi-site studies that can answer important questions about TB outcomes.
What scientific questions is the network expected to address?
The network is designed to study how community-level conditions, host biology, and microbial factors influence the course and outcomes of TB infection and TB disease. It also seeks to clarify why outcomes vary, such as why some patients respond well to therapy while others relapse, fail treatment, or have poor outcomes.
Which populations or topics are emphasized in the scope?
A major emphasis is tuberculosis among persons with HIV (PWH), reflecting the high burden and complexity of TB/HIV co-infection. The scope also includes drug-resistant TB.
Why is TB among persons with HIV (PWH) a major focus?
The opportunity highlights TB/HIV co-infection as especially burdensome and complex, and it prioritizes research that improves understanding of TB outcomes in people living with HIV.
Does the scope include drug-resistant tuberculosis?
Yes. Drug-resistant TB is explicitly included, with interest in understanding why some patients do well while others relapse, fail treatment, or experience poor outcomes.
What are examples of the kinds of outputs this program aims to accelerate?
By clarifying drivers of TB outcomes, the program aims to accelerate development of practical tools that can improve patient-level treatment outcomes (for example, better predictors of risk, disease progression, or treatment response) and inform larger public health strategies to reduce transmission and help curb the TB epidemic.
Is this a single study or a networked program?
It is designed as a networked effort rather than a single stand-alone study. RePORT networks typically use harmonized protocols, common data elements, coordinated enrollment and follow-up, and approaches that allow combining data across sites.
What does "harmonized protocols" and "common data elements" mean in this context?
In this network setting, it refers to using standardized methods for collecting information and specimens across participating sites so that data can be pooled or compared reliably, enabling larger and more consistent analyses.
What is the expected end product of this funding opportunity?
The expected end product is a stronger platform for longitudinal observational TB research in Brazil, closely linked with US collaborators, that can address research questions at scale using consistent methods and standardized data and specimen collection.
Who is the funding agency?
The funding agency is the National Institutes of Health (NIH).
What is the program classification (CFDA) number listed for this opportunity?
The program classification (CFDA) is 93.855.
Who is eligible to apply?
Eligibility is broad and includes many US-based and non-US entity types. Eligible applicants listed 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; other Native American tribal organizations; public housing authorities/Indian housing authorities; nonprofits with and without 501(c)(3) status (excluding institutions of higher education within those nonprofit categories); for-profit organizations other than small businesses; small businesses; and other organizations.
Are non-US (foreign) organizations eligible?
Yes. The eligibility list explicitly includes non-domestic (non-US) entities/foreign organizations.
Are US territories or possessions eligible?
Yes. US territories or possessions are explicitly highlighted among eligible applicant groups.
Are faith-based or community-based organizations eligible?
Yes. Faith-based or community-based organizations are specifically highlighted as eligible applicant groups.
Are minority-serving institutions mentioned as eligible?
Yes. The opportunity highlights several categories, including Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISI), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), and Tribally Controlled Colleges and Universities (TCCUs).
Are tribal governments and tribal organizations eligible?
Yes. The eligibility list includes federally recognized Native American tribal governments, other Native American tribal organizations, and also highlights Indian/Native American tribal governments that are not federally recognized.
Are federal agencies eligible to apply?
Yes. Eligible federal agencies are highlighted among additional eligible applicant groups.
What is the award ceiling listed in the source data?
The award ceiling is listed as 700,000. Based on the excerpt, this is typically interpreted as an annual maximum per award unless the full FOA specifies otherwise.
How many awards are expected?
The expected number of awards is not provided in the excerpted information.
What is the opportunity creation date?
The opportunity creation date listed is 2021-08-05.
What is the closing date listed for this opportunity?
The original closing date listed is 2021-12-08.
What does "prospective observational" mean for this opportunity?
In this context, it means the network is expected to follow individuals forward in time, collecting standardized data and specimens to observe TB-related outcomes and associated factors, rather than assigning interventions as part of a clinical trial.
What kinds of factors are specifically mentioned as influencing TB outcomes?
The opportunity highlights three broad categories: community-level conditions, host biology, and microbial factors.
What kinds of outcomes does the program want to better understand?
The program aims to deepen understanding of different TB outcomes, including response to therapy and unfavorable outcomes such as relapse, treatment failure, and other poor outcomes.
How is NIH expected to be involved under a U01 cooperative agreement?
Because it is a cooperative agreement, NIH is expected to have substantial involvement, which can include coordination expectations, shared governance structures, and regular interaction between awardees and the funding institute to ensure the network meets program goals.
Does this opportunity emphasize standardized specimens as well as data?
Yes. A core idea is to generate high-quality, standardized data and specimens to support deeper understanding of drivers of TB outcomes.
What is the overall public health aim described for this opportunity?
Beyond improving individual patient outcomes through better predictors and insights, the broader aim is to inform public health strategies that reduce transmission and help curb the TB epidemic.
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