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

FAQs: Feasibility of Novel Diagnostics for TB in Endemic Countries (FEND for TB)

1) What is the FEND for TB funding opportunity?

FEND for TB (Feasibility of Novel Diagnostics for TB in Endemic Countries) 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 countries where TB is common. It supports feasibility and proof-of-principle evaluation studies of novel TB diagnostic tests and diagnostic strategies in TB-endemic settings.

2) What is the main purpose of this opportunity?

The main purpose is to accelerate learning about novel TB diagnostics by funding practical studies that assess whether a new test or strategy can work in routine, endemic-country clinical environments and to generate results that can guide diagnostic developers on performance and best-use deployment strategies.

3) Is this opportunity meant to fund large validation studies?

No. The central aim is not to fund large, definitive validation trials. Instead, it focuses on targeted feasibility and proof-of-principle evaluations that provide early evidence and help determine whether a diagnostic is ready to advance to larger studies.

4) What types of studies does the FOA want to support?

The FOA emphasizes practical feasibility and proof-of-principle evaluation studies of new TB diagnostic tests and novel diagnostic strategies carried out in TB-endemic countries. These studies are expected to generate early evidence of performance in intended settings and produce actionable feedback for diagnostic developers.

5) What does "proof-of-principle" mean in this context?

Based on the FOA description, proof-of-principle refers to early evaluation work that demonstrates a novel diagnostic test or strategy can function in the intended real-world environment and can plausibly fit into local clinical workflows, without moving into large, definitive validation trials.

6) Where are projects expected to be conducted?

Projects are intended to be conducted in TB-endemic countries, reflecting the program focus on evaluating diagnostics in places where TB is common and where the diagnostic pathway and operational realities may differ from idealized laboratory settings.

7) Why does the FOA emphasize evaluation in TB-endemic countries?

The FOA stresses endemic-country evaluation so that findings reflect how the technology would actually perform in routine care, including real constraints such as staffing, infrastructure, workflow, and turnaround time, rather than performance under ideal laboratory conditions.

8) Does the FOA require that innovations be tested within existing clinical diagnostic algorithms?

Yes. A key emphasis is testing novel diagnostics within, and alongside, existing clinical diagnostic algorithms already used in TB-endemic settings, so the results are directly relevant to routine clinical decision-making.

9) What does it mean to test a diagnostic "within and alongside" existing algorithms?

It means the evaluation should consider how the novel test or strategy fits into the current diagnostic pathway already used locally, rather than testing it only in isolation. The goal is to learn how it performs and how it could realistically be deployed in the real clinical workflow.

10) What are the two main expected outcomes of work funded under this announcement?

The FOA expects funded projects to: (1) generate early evidence that a novel test or strategy can work in the intended setting and provide information to judge whether it is worth scaling up to larger studies; and (2) deliver actionable feedback to diagnostic developers about performance and the most effective deployment approach in an endemic context.

11) What kinds of "actionable feedback" is NIH looking for?

The FOA highlights feedback that helps developers understand performance and best-use strategies in endemic settings, including practical considerations that affect usefulness such as turnaround time, ease of use, robustness, staffing needs, compatibility with local infrastructure, and realistic specimens and workflows.

12) What parts of the diagnostic pathway should applicants think about?

Applicants are expected to consider where the test fits in the diagnostic pathway, such as triage, confirmatory testing, or treatment monitoring, and evaluate the test or strategy in ways that reflect that intended role in the local clinical setting.

13) What operational and implementation factors does the FOA emphasize?

The FOA emphasizes practical constraints and details that can determine whether a diagnostic is usable in routine care, including turnaround time, ease of use, robustness, staffing needs, compatibility with local infrastructure, and whether specimens and workflows are realistic in the target setting.

14) What funding mechanism is used for this opportunity?

This opportunity is offered as a cooperative agreement (U01).

15) What does a cooperative agreement (U01) imply for the project?

A U01 generally means NIH expects substantial involvement during the project, such as scientific coordination, milestone-driven progress, and ongoing collaboration to keep the project aligned with program goals.

16) What is the activity category associated with this opportunity?

The activity category is health.

17) What CFDA listing is associated with this opportunity?

The listing is associated with CFDA 93.855.

18) Are clinical trials allowed under this FOA?

No. The FOA explicitly states "Clinical Trial Not Allowed."

19) If clinical trials are not allowed, what kinds of evaluations are acceptable?

Based on the FOA description, projects may assess diagnostic feasibility, proof-of-principle performance, and how a diagnostic might be used within routine clinical algorithms. However, the work should not be structured as a clinical trial as defined by NIH rules (for example, a prospective assignment to interventions to evaluate health outcomes).

20) Can a project evaluate diagnostic performance without being a clinical trial?

Yes. The FOA indicates that projects can evaluate how a diagnostic behaves and how it might be used in real settings, as long as the study is not designed as an interventional clinical trial where participants are prospectively assigned to interventions to measure health outcomes.

21) Who is eligible to apply?

Eligibility is broad and includes many organization types, such as state, county, city/township, and special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; 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.

22) Are tribal entities eligible?

Yes. Federally recognized Native American tribal governments and tribal organizations that are not federally recognized are listed as eligible applicants.

23) Are public housing authorities eligible?

Yes. Public housing authorities/Indian housing authorities are included among eligible applicants.

24) Are minority-serving institutions specifically mentioned as eligible?

Yes. The FOA highlights eligibility for 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; and Tribally Controlled Colleges and Universities (TCCUs).

25) Are faith-based or community-based organizations eligible?

Yes. Faith-based or community-based organizations are explicitly highlighted among eligible applicant categories.

26) Are U.S. federal agencies eligible?

Yes. Eligible federal agencies are listed among additional eligible applicant categories.

27) Are U.S. territories or possessions eligible?

Yes. U.S. territories or possessions are included among the highlighted eligible applicant categories.

28) Are non-U.S. entities (foreign organizations) eligible to apply?

Yes. The FOA explicitly includes non-U.S. entities (foreign organizations) and regional organizations as eligible applicants, consistent with the focus on TB-endemic countries and on-the-ground evaluation.

29) Does the FOA require collaboration with TB-endemic country sites?

The information provided indicates eligibility is broad and includes entities that could partner effectively with TB-endemic country sites and diagnostic developers, and the program focus is on evaluation in endemic settings. The provided text does not state a specific collaboration requirement, but the work is clearly intended to be conducted in TB-endemic countries.

30) What is the FOA identifier for this opportunity?

The opportunity is identified as RFA AI 19 030.

31) When was this funding opportunity created?

It was created on 2019-04-11.

32) What was the original closing date?

The original closing date was 2019-07-22.

33) Does the provided information specify an award ceiling or number of awards?

No. The source information provided does not specify an award ceiling or the expected number of awards.

34) What kinds of diagnostic innovations are in scope?

The FOA is intended to support promising, early stage TB diagnostic ideas, including new TB diagnostic tests and novel diagnostic strategies, with an emphasis on evaluating them in the context of routine care in TB-endemic environments.

35) What is NIH trying to learn from these projects?

NIH is aiming to learn whether a novel diagnostic test or strategy is feasible and shows proof-of-principle performance in the intended real-world endemic setting, and to generate practical information about how to deploy it effectively within existing clinical pathways.