Omics Data Generation Centers (ODGCs) for Common Fund Acute to Chronic Pain Signatures Program (U54 Clinical Trial Optional) | RFA RM 18 032

Frequently Asked Questions (FAQs)

What is the title of this funding opportunity?

The opportunity is titled "Omics Data Generation Centers (ODGCs) for the Common Fund Acute to Chronic Pain Signatures (A2CPS) Program (U54 Clinical Trial Optional)."

What is the funding opportunity number (FOA number)?

The funding opportunity number is RFA-RM-18-032.

Which federal agency is offering this grant?

This is a National Institutes of Health (NIH) solicitation, described as part of an NIH Common Fund effort.

What is the overall purpose of the ODGCs under this FOA?

The purpose is to establish one or more specialized centers that can generate high-quality, cutting-edge omics datasets from patient body-fluid samples collected through the A2CPS program. These centers act as dedicated facilities that run advanced molecular assays on A2CPS samples so the resulting molecular profiles can be integrated with clinical and phenotypic data to discover biosignatures related to pain outcomes.

How does this FOA relate to the A2CPS program?

A2CPS is collecting biological specimens and a broad range of clinical and phenotypic measurements from people at risk of transitioning from acute pain to chronic pain. The ODGCs are intended to generate standardized molecular (omics) measurements on those specimens so that omics data can be combined with the rest of the A2CPS data to identify predictive biosignatures.

What problem is this program trying to solve?

The program is focused on understanding and predicting the transition from acute pain to chronic pain. Specifically, it aims to discover biosignatures that can help predict who is more likely to develop chronic pain (susceptibility) versus who is more likely to recover or avoid chronification (resilience).

What kinds of biological samples are expected to be used for omics profiling?

The FOA describes generating omics datasets from patient body-fluid samples collected as part of A2CPS.

Which omics modalities are specifically highlighted in the FOA description?

The modalities specifically highlighted are metabolomics, lipidomics, proteomics, and extracellular RNA.

Why are these omics modalities emphasized?

They are presented as part of a comprehensive, systems-level measurement strategy intended to capture biological pathways that may track with pain persistence (chronification) or pain resolution (recovery/resilience).

What is the grant mechanism used for this opportunity?

The mechanism is a cooperative agreement (U54).

What does it mean that this is a cooperative agreement (U54)?

The description indicates that a cooperative agreement typically involves substantial NIH programmatic involvement beyond standard grant oversight. It is commonly used for large, coordinated, multi-site or consortium-style efforts where harmonization, shared standards, consistent data-generation pipelines, and active coordination with NIH and other consortium members are essential.

What does "Clinical Trial Optional" mean in this FOA?

The FOA is labeled "Clinical Trial Optional." The description also indicates the focus of the centers is fundamentally on omics data generation and related activities; any clinical trial component is not the defining feature of the work, but applicants have flexibility depending on how their proposed center operations are structured.

Is the main deliverable simply generating more data?

No. The description emphasizes that the deliverable is omics data generated using state-of-the-art technologies and suitable for identifying robust biosignatures, not just data volume.

What quality expectations are implied for the omics data produced?

The description implies strong expectations around assay performance, reproducibility, standard operating procedures, quality control/quality assurance, and consistent handling of samples and metadata so that data are standardized and comparable across participants and timepoints.

How will the generated omics data be used within A2CPS?

The molecular profiles generated by the ODGCs are intended to be integrated with A2CPS clinical and assessment data, including clinical/phenotypic measurements and patient-reported outcomes, to uncover biological patterns linked to pain trajectories and to support discovery of predictive biosignatures.

Are the samples and data expected to be clinically anchored or longitudinal?

The description indicates the work is implicitly tied to longitudinal or otherwise clinically anchored sample sets and analyses that can be correlated with clinical exams, patient-reported outcomes, and other A2CPS assessments.

What role do ODGCs play within the broader consortium?

The ODGCs are described as core enabling infrastructure for the A2CPS consortium. They serve as specialized production hubs that generate standardized molecular measurements to support cross-participant and cross-timepoint comparisons and integration with other A2CPS data types.

Who is eligible to apply?

Eligibility is broad and includes: state, county, and local governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized tribal governments; tribal organizations that are not federally recognized; public housing authorities/Indian housing authorities; nonprofits (501(c)(3) and non-501(c)(3), excluding higher education institutions in those nonprofit categories); for-profit organizations other than small businesses; and small businesses.

Are any additional applicant types explicitly mentioned as eligible?

Yes. The FOA also explicitly calls out Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), 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 foreign (non-U.S.) institutions eligible to apply as the applicant organization?

No. Foreign institutions (non-U.S. entities) are not eligible to apply as applicant organizations.

Is any international involvement allowed under this FOA?

Yes, in limited forms described in the excerpt: non-domestic components of U.S. organizations may apply, and foreign components (as NIH defines them in its Grants Policy Statement) are allowed. This provides a pathway for international involvement through U.S.-led applications.

What is the CFDA number associated with this opportunity?

The CFDA number listed is 93.310.

How is this program categorized administratively?

It is listed as a discretionary program in the health area and uses the NIH Cooperative Agreement mechanism.

When was this opportunity created, and what was the original closing date?

The creation date is August 24, 2018, and the original closing date was October 24, 2018.

Does the excerpt specify an award ceiling or the expected number of awards?

No. The excerpted text does not provide an award ceiling or an expected number of awards, but it states an intent to establish one or more centers.

What scale of effort does NIH appear to be seeking?

Based on the cooperative agreement structure and the stated goal to establish one or more specialized centers delivering standardized omics data generation for a consortium, the FOA is aimed at a consortium-supporting scale with coordination, harmonization, and consistent pipelines across sites.

What is the key scientific outcome NIH is aiming for?

The key outcome is the discovery of molecular biosignatures that forecast whether acute pain will resolve or progress into chronic pain, enabled by high-quality omics profiling integrated with A2CPS clinical and phenotypic data.