Tissue Mapping Centers for the Human BioMolecular Atlas Program (U54 Clinical Trial Not Allowed) | RFA RM 21 026

FAQs: NIH RFA-RM-21-026 Tissue Mapping Centers for the Human BioMolecular Atlas Program (U54 Clinical Trial Not Allowed)

What is the funding opportunity?

This opportunity is the National Institutes of Health (NIH) Funding Opportunity Announcement (FOA) RFA-RM-21-026, titled "Tissue Mapping Centers for the Human BioMolecular Atlas Program (U54 Clinical Trial Not Allowed)." It funds Tissue Mapping Centers (TMCs) that serve as primary data-generation hubs for the Human BioMolecular Atlas Program (HuBMAP) Consortium.

What is the main goal of this program?

The central goal is to produce a high-resolution, multi-parameter, three-dimensional atlas of a non-diseased human organ. The program aims to generate reference-quality maps that reveal molecular, cellular, and structural organization in intact human tissues.

What is a Tissue Mapping Center (TMC) expected to do?

A TMC is expected to generate high-quality tissue mapping data and to function as a trusted hub for producing standardized, reproducible outputs for the HuBMAP Consortium. This includes developing and operating end-to-end experimental and computational pipelines and producing integrated maps suitable for a published reference atlas.

What types of technologies or approaches are emphasized?

The FOA emphasizes pushing the technical state of the art by combining multiplexed, high-throughput imaging with omics approaches, then converting raw measurements into integrated maps that capture organization within intact human tissues.

Is the focus only on generating datasets?

No. A major focus is building complete, reliable, and standardized pipelines that others in the consortium can trust and reuse. The program emphasizes benchmarking, validation, and standardization so outputs are comparable and reproducible rather than one-off datasets.

What does "end-to-end workflow" mean in this FOA?

It refers to the full set of steps needed to produce usable atlas data, including tissue collection and handling, preservation methods, assay execution, quality control, validation, and computational processing, as well as downstream data integration, analysis, and biological interpretation.

Why are benchmarking and standardization highlighted?

Benchmarking and standardization are highlighted to ensure the resulting maps and datasets are comparable across donors and consistent across centers, enabling reliable integration into a consortium-wide, public reference atlas.

What kinds of biological insights are the resulting atlases intended to provide?

The atlases are intended to provide insight into how human tissues are organized across multiple spatial scales, including within cells, between cells, and in the surrounding extracellular environment.

What types of variation should the maps help illuminate?

The FOA highlights variation within a tissue region, differences among individuals, and changes across the lifespan as key types of variation the maps should help reveal.

Does this FOA support clinical trials?

No. The FOA is explicitly labeled "Clinical Trial Not Allowed," and it is designed to create reference-quality atlases of non-diseased human organs rather than conduct clinical trials.

What are the expected deliverables by the end of the project?

By the end of a four-year project period, a successful TMC is expected to produce a substantial collection of high-resolution, multi-scale, multi-dimensional maps derived from multiple donors and to have outputs integrated into a published reference atlas for the selected organ in alignment with HuBMAP consortium goals.

How long is the project period described in the opportunity?

The opportunity describes a four-year project period.

What is the funding mechanism and what does it imply?

The award uses a U54 cooperative agreement mechanism. This typically implies more hands-on NIH involvement than standard grants, reflecting the consortium nature of HuBMAP and the need for coordination across groups contributing data, methods, and shared standards.

Which agency is offering this opportunity?

The agency listed for this opportunity is the National Institutes of Health (NIH).

What is the CFDA number and how is the opportunity categorized?

The opportunity is categorized as a discretionary, health-related cooperative agreement with CFDA 93.310.

Who is eligible to apply?

Eligibility is broad and includes many types of U.S.-based entities, including state, county, and local governments; special districts; 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 and without 501(c)(3) status (other than higher education institutions); for-profit organizations other than small businesses; small businesses; and other eligible applicants.

Are there specific institution types explicitly called out as eligible?

Yes. The FOA explicitly calls out additional eligible categories including 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.

Can a non-U.S. organization apply as the main applicant?

No. Non-domestic (non-U.S.) entities and non-domestic components of U.S. organizations are not eligible to apply as the applicant organization under this FOA.

Are foreign collaborations allowed in any form?

Yes, in a limited way. Foreign components are allowed as defined under the NIH Grants Policy Statement, meaning the prime awardee must be a domestic eligible organization while certain defined foreign components may be permissible if they meet NIH policy requirements.

What organ types are targeted?

The FOA describes the goal as building a high-resolution atlas of a non-diseased human organ, but the provided information does not specify which organs must be selected.

What is the relationship to the HuBMAP Consortium?

TMCs funded under this FOA are part of the HuBMAP Consortium framework. Their outputs are expected to align with consortium-wide goals for public, standardized resources, and to be integrated into a published reference atlas.

What is the emphasis on data integration and interpretation?

The FOA emphasizes integrating and optimizing each part of the pipeline, including downstream steps like data integration, analysis, and biological interpretation, to produce consistent high-resolution maps across donors that are useful to the broader research community.

What are the key dates listed for this opportunity?

The source listing includes a creation date of 2021-09-14 and an original closing date of 2021-11-19.

What does it mean that these atlases are "reference-quality" and "non-diseased"?

Based on the provided description, the program is seeking baseline, spatially resolved molecular and morphological maps of healthy human organs. These references are meant to support understanding normal human biology and enable future comparisons to disease states, even though this FOA itself is not designed to run clinical trials.