Feasibility of Novel Diagnostics for TB in Endemic Countries (FEND for TB) (R01 Clinical Trial Not Allowed) | RFA AI 24 010

Opportunity Information: Apply for RFA AI 24 010

The Feasibility of Novel Diagnostics for TB in Endemic Countries (FEND for TB) funding opportunity (RFA-AI-24-010) is a National Institutes of Health (NIH) discretionary grant solicitation that supports R01 research projects focused on early-stage tuberculosis (TB) diagnostics and new diagnostic strategies in real-world, TB-endemic settings. The central goal is to generate practical evidence on how promising new tests or testing approaches perform when placed into existing clinical workflows and decision-making algorithms used in countries where TB burden is high. The NOFO is explicitly designed for evaluation and feasibility work at an early stage of diagnostic development rather than late-stage confirmatory trials, and it is labeled "Clinical Trial Not Allowed," meaning applicants should propose studies that do not meet the NIH definition of a clinical trial.

Projects funded under this opportunity are expected to do two main things. First, they should run proof-of-principle evaluations of novel TB diagnostic tests or diagnostic strategies. This can include assessing new assay concepts, platforms, biomarkers, specimen types, or testing workflows, and it should be done in the context of how clinicians and programs actually evaluate patients for TB in endemic settings. A clear emphasis is placed on including populations that are often challenging to diagnose, particularly people living with HIV (PLWH), since HIV co-infection can change disease presentation and reduce the performance of some conventional diagnostics. Second, studies should produce actionable feedback for two audiences: diagnostic developers, who need data to refine products and target use-cases, and policy makers or guideline-setting bodies, who need evidence to understand where a technology fits in an algorithm and what strategy yields the best clinical or programmatic value in routine practice.

In practical terms, the NOFO is about bridging the gap between a promising diagnostic idea and the kind of evidence needed to guide next-step development and implementation planning. Applications should be framed around how the diagnostic would be used in an endemic-country health system, how it compares or complements current approaches, and what operational or clinical insights the study will produce. The focus on "existing clinical algorithms" signals that reviewers will look for proposals that are grounded in current standards of care and realistic patient pathways, rather than highly artificial testing scenarios that do not reflect how TB diagnosis happens on the ground.

The award mechanism is an NIH R01 research project grant, under the health funding activity category (CFDA 93.855). The opportunity lists an award ceiling of $3,500,000. The original closing date provided is June 28, 2024, and the NOFO was created on March 27, 2024. While the number of expected awards is not specified in the provided data, the ceiling indicates support for substantial, multi-year evaluation efforts that can include field-based components, partnerships with endemic-country sites, and robust analytic plans.

Eligibility is broad and includes many U.S.-based entity types as well as non-U.S. organizations. Eligible applicants include state, county, city/township, and 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 that are not federally recognized; public housing authorities/Indian housing authorities; nonprofit organizations with or without 501(c)(3) status; for-profit organizations (other than small businesses); and small businesses. The NOFO also highlights additional eligible groups such as Alaska Native and Native Hawaiian Serving Institutions, AANAPISI institutions, 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, and non-domestic (non-U.S.) entities/foreign organizations. This breadth aligns with the global and cross-sector nature of TB diagnostics development and evaluation, where collaborations among academic groups, implementers, ministries of health partners, and technology developers are often essential.

Overall, FEND for TB funds feasibility and early validation-style evaluation studies that test whether new TB diagnostic tools or strategies can meaningfully improve or streamline TB case detection in endemic countries, including in PLWH, and it prioritizes outputs that directly inform product development decisions and policy-relevant guidance on how and where to deploy new diagnostics within existing clinical pathways.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Feasibility of Novel Diagnostics for TB in Endemic Countries (FEND for TB) (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 2024-03-27.
• Applicants must submit their applications by 2024-06-28. (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 $3,500,000.00 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.

Apply for RFA AI 24 010

[Watch] Creating a grant proposal using the step-by-step wizard inside the applicant portal: