Data and Modeling Coordination Center for the NHLBI's Precision Interventions for Severe and/or Exacerbation-Prone Asthma (PrecISE) Network (U24) | RFA HL 17 010

Opportunity Information: Apply for RFA HL 17 010

The National Heart, Lung, and Blood Institute (NHLBI), part of the National Institutes of Health (NIH), solicited applications for a single Data, Modeling, and Coordination Center (DMCC) to support the Precision Interventions for Severe and/or Exacerbation-Prone Asthma (PrecISE) Network. This opportunity was issued as a cooperative agreement (U24), meaning the awardee would not simply receive funds and operate independently, but would work closely with NHLBI staff and the broader network under a substantial level of NIH scientific and programmatic involvement. The FOA is identified as RFA-HL-17-010, was posted July 28, 2016, and had an original application due date of December 20, 2016.

The PrecISE Network itself is designed as a clinical trial network focused on people with severe asthma or asthma that is particularly prone to exacerbations, a population that often does not respond well to standard treatment approaches. The network aims to run sequential, adaptive, Phase II or proof-of-concept clinical trials. In practical terms, this means trials are intended to be flexible and data-driven, allowing decisions to be adjusted over time based on accumulating results, rather than locking every design choice in place from the outset. A central theme is "precision interventions" tested in stratified patient groups, where participants are categorized using clinically meaningful phenotypes and/or biologically defined endotypes. The network also emphasizes the use of predictive biomarkers (to help choose the right intervention for the right subgroup) and monitoring biomarkers or profiles (to track response and guide adaptation during the trial sequence). The overall goal is to identify the most effective precision treatment strategies for a hard-to-treat asthma population.

Within that structure, the DMCC is the backbone that enables the multi-site trials to function as one coordinated program. The FOA calls for one DMCC to serve multiple Clinical Centers, handling core functions such as network-wide coordination, data management and harmonization, and analytic and modeling support needed for adaptive trial designs and biomarker-informed stratification. While the notice does not list every task in detail in the excerpt provided, the title and description make clear that the DMCC is expected to integrate three major responsibilities: (1) data operations and stewardship for complex, multi-center clinical trial datasets, including biomarker and profiling information; (2) modeling and quantitative support to enable sequential adaptive decision-making and to evaluate intervention performance across stratified subgroups; and (3) overall coordination activities that keep protocol execution consistent across sites, support trial logistics, and ensure the network can run multiple linked trials efficiently over time.

This DMCC FOA was released in parallel with a companion solicitation for the Clinical Centers (RFA-HL-17-009). Applicants were therefore responding to one piece of a two-part network build, where Clinical Centers recruit and manage participants and conduct the clinical work, and the DMCC centrally supports design, operations, analytics, and coordination across all sites. The activity category is Health, and the CFDA listing provided is 93.838.

Eligibility is broad and includes many types of domestic U.S. organizations and governments, such as state, county, and city governments; special district governments; independent school districts; public and state-controlled and private institutions of higher education; federally recognized tribal governments and certain tribal organizations; 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) and small businesses; and other entities. The FOA also explicitly highlights additional eligible applicant types, including 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, and U.S. territories or possessions. At the same time, non-U.S. entities (foreign organizations and foreign institutions) are not eligible to apply, and non-domestic components of U.S. organizations are not eligible. However, foreign components, as defined under the NIH Grants Policy Statement, are allowed, which typically means a U.S. applicant may include certain types of foreign collaborations or performance sites if they meet NIH policy requirements and are justified within the proposed work.

Notably, the public summary information included here does not specify an award ceiling or the expected number of awards, but it does clearly indicate that only one DMCC would be supported for the network, consistent with the "single DMCC" language. Overall, this FOA is best understood as a call for a highly capable coordinating and analytics hub that can manage complex data streams, support adaptive trial methodology, and keep a multi-center precision-medicine asthma trial network operating smoothly and consistently while it tests targeted interventions in biomarker-defined patient subgroups.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Data and Modeling Coordination Center for the NHLBI's Precision Interventions for Severe and/or Exacerbation-Prone Asthma (PrecISE) Network (U24)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.838.
• This funding opportunity was created on 2016-07-28.
• Applicants must submit their applications by 2016-12-20. (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.

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