Feasibility of Novel Diagnostics for TB in Endemic Countries (FEND for TB) (U01 Clinical Trial Not Allowed) | RFA AI 19 030

Opportunity Information: Apply for RFA AI 19 030

Feasibility of Novel Diagnostics for TB in Endemic Countries (FEND for TB) is a National Institutes of Health (NIH) funding opportunity designed to move promising, early stage tuberculosis (TB) diagnostic ideas closer to real-world use in places where TB is common. The central aim is not to fund large, definitive validation trials, but to support practical feasibility and proof-of-principle evaluation studies of new TB diagnostic tests and novel diagnostic strategies in TB-endemic countries. A key emphasis is testing these innovations within, and alongside, existing clinical diagnostic algorithms already used in those settings, so that findings reflect how the technology would actually perform in routine care rather than in idealized laboratory conditions.

The work supported under this announcement is expected to do two main things. First, it should generate early evidence that a novel test or strategy can work in the intended setting, including information that helps determine whether it is worth scaling up to larger studies. Second, the studies should deliver actionable feedback to diagnostic developers, focusing on performance and the most effective way to deploy the technology in an endemic context. In practice, this means applicants should be thinking about questions like where the test fits in the diagnostic pathway (triage, confirmatory testing, treatment monitoring, etc.), what specimens and workflows are realistic, what operational constraints exist, and what implementation details can make or break usefulness (turnaround time, ease of use, robustness, staffing needs, and compatibility with local infrastructure).

This opportunity is offered as a cooperative agreement (U01), which generally means NIH expects substantial involvement during the project, such as scientific coordination, milestone-driven progress, and ongoing collaboration to ensure the project stays aligned with program goals. The activity category is health, and the listing is associated with CFDA 93.855. The FOA explicitly states "Clinical Trial Not Allowed," signaling that applicants must design studies that evaluate diagnostic feasibility and performance without proposing a clinical trial as defined by NIH rules. In other words, the project can assess how a diagnostic behaves and how it might be used, but it should not be structured as an interventional clinical trial where participants are prospectively assigned to interventions to evaluate health outcomes.

Eligibility is broad and includes many types of organizations that could partner effectively with TB-endemic country sites and diagnostic developers. Eligible applicants listed 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; nonprofits (with or without 501(c)(3) status) other than institutions of higher education; for-profit organizations other than small businesses; small businesses; and other entities. The FOA also highlights additional eligible applicant categories such as Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISIs); Historically Black Colleges and Universities (HBCUs); Hispanic-serving institutions; Tribally Controlled Colleges and Universities (TCCUs); faith-based or community-based organizations; eligible federal agencies; U.S. territories or possessions; and importantly, non-U.S. entities (foreign organizations) and regional organizations, which is consistent with the focus on TB-endemic countries and on-the-ground evaluation.

The opportunity is identified as RFA AI 19 030, created on 2019-04-11, with an original closing date of 2019-07-22. While the source information provided does not specify an award ceiling or the expected number of awards, the overall purpose is clear: to accelerate learning about novel TB diagnostics by funding targeted, context-aware feasibility and proof-of-principle evaluations, and to translate study results into concrete guidance for developers about performance and best-use strategies in TB-endemic clinical environments.

• 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) (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 2019-04-11.
• Applicants must submit their applications by 2019-07-22. (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.

Apply for RFA AI 19 030

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