Brazil Regional Prospective Observational Research in Tuberculosis (RePORT) (U01 Clinical Trial Not Allowed) | PAR 21 304

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.

• 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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