Consortium for Design of TB Drug Regimens (UM1 Clinical Trial Not Allowed) | RFA AI 22 059

Frequently Asked Questions (FAQs)

What is RFA-AI-22-059 about?

RFA-AI-22-059 is a National Institutes of Health (NIH) funding opportunity announcement titled "Consortium for Design of TB Drug Regimens (UM1 Clinical Trial Not Allowed)." It supports building a coordinated consortium focused on improving how tuberculosis (TB) drug regimens are designed and prioritized before they move into human testing.

What is the main goal of this funding opportunity?

The central goal is to strengthen the evidence and predictive power of preclinical approaches used to select TB combination drug regimens. The consortium is meant to bring together preclinical and clinical TB experts to systematically evaluate and refine preclinical models using analyses of relevant preclinical and clinical datasets.

Is this opportunity intended to fund clinical trials?

No. The FOA title explicitly states "Clinical Trial Not Allowed," and the described intent is not to run clinical trials under this award. Instead, the work is meant to improve the preclinical-to-clinical translation so future clinical testing (funded through other mechanisms) can focus on the most promising regimens.

If clinical trials are not allowed, how is the work still clinically relevant?

The consortium is expected to stay tightly connected to clinical relevance by comparing preclinical signals with real-world clinical outcomes. The work includes analyzing which preclinical readouts correlate with clinical success, failure, relapse, or resistance, and then iterating on model design so preclinical results are more predictive of patient outcomes.

What types of activities is the consortium expected to perform?

Based on the description, expected activities include harmonizing data, developing and/or optimizing modeling frameworks, comparing how well different preclinical models predict clinical performance, and producing decision-ready recommendations about which combination regimens have the strongest justification to advance into later clinical evaluation.

What is meant by a "consortium" in this announcement?

A consortium here refers to a coordinated, multi-expert effort that brings together preclinical and clinical TB expertise. The emphasis is on integration and coordination across participants to systematically evaluate models and datasets and produce outputs that directly inform regimen selection.

What NIH funding mechanism is used for this opportunity?

This opportunity uses a cooperative agreement mechanism (UM1).

What does a UM1 cooperative agreement imply for awardees?

A UM1 cooperative agreement indicates substantial NIH involvement. Awardees should expect NIH to be involved in shaping scientific direction, setting or negotiating milestones, and coordinating efforts across the consortium.

What health area or topic does this opportunity fall under?

The opportunity is in the health category and is focused on tuberculosis (TB) drug regimen design and prioritization, particularly strengthening translational links between preclinical models and clinical outcomes.

What is the CFDA number associated with this opportunity?

The associated CFDA number is 93.855.

What problem is this consortium trying to solve for TB regimen development?

The consortium aims to reduce uncertainty and wasted effort in downstream clinical development by improving confidence that preclinical findings will translate to patient outcomes. In practice, this means improving how reliably the field can identify the most promising combination regimens to move forward.

What kinds of data are expected to be used?

The announcement emphasizes analyzing relevant preclinical and clinical datasets. The focus is on using existing results and outcomes to refine model systems and evaluate which preclinical signals best track with clinical performance.

What types of outputs are implied by the description?

The description points to outputs such as harmonized datasets, refined or optimized modeling approaches, comparisons of model predictiveness, and decision-ready recommendations that support selecting which TB drug combinations should be tested next in clinical studies (outside of this award).

Who is eligible to apply?

Eligibility is broad across U.S.-based organizations. Eligible applicants include state, county, city or township 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; tribal organizations that are not federally recognized; public housing authorities/Indian housing authorities; nonprofit organizations (with or without 501(c)(3) status) that are not institutions of higher education; for-profit organizations other than small businesses; small businesses; and other eligible entities.

Are specific institution types explicitly highlighted as eligible?

Yes. The announcement explicitly highlights additional eligible categories 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, regional organizations, eligible federal agencies, and U.S. territories or possessions.

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

No. Non-domestic (non-U.S.) entities and foreign institutions are not eligible to apply.

Can a U.S. organization include non-U.S. components in the project?

No. The announcement states that non-domestic components of U.S. organizations are not eligible.

Are any foreign activities allowed at all?

Yes. "Foreign components" as defined under the NIH Grants Policy Statement are allowed. This typically means a U.S. applicant can include certain well-justified and separately described foreign activities or collaborations, as long as the overall application remains compliant with NIH policy.

What is the original closing date listed in the information provided?

The original closing date listed is February 7, 2023.

What is the FOA creation date?

The FOA creation date is September 21, 2022.

Does the provided summary list an award ceiling or expected number of awards?

No. The source summary does not list an award ceiling or the expected number of awards, suggesting those details were not specified in the extracted fields or may be available elsewhere in the full FOA text.

What is the overall intended endpoint of the consortium's work?

The intended endpoint is a more reliable, data-driven pipeline for prioritizing TB combination regimens. The consortium is meant to improve preclinical model predictiveness so the field can make stronger, more defensible choices about which regimens should advance into future clinical testing funded through other mechanisms.