Clinical Centers for the NHLBI's Precision Interventions for Severe and/or Exacerbation Prone Asthma (PrecISE) Network (UG1) | RFA HL 17 009

Opportunity Information: Apply for RFA HL 17 009

The National Heart, Lung, and Blood Institute (NHLBI), part of the National Institutes of Health (NIH), released this funding opportunity to build out the Clinical Centers for the Precision Interventions for Severe and/or Exacerbation Prone Asthma (PrecISE) Network under a UG1 cooperative agreement mechanism. The overall goal is to create a coordinated clinical trial network focused on people with severe asthma or asthma that is especially prone to exacerbations, meaning patients who continue to have frequent flare-ups or remain poorly controlled despite current standard therapies. Rather than running one traditional trial at a time, PrecISE is designed to run sequential, adaptive phase II (proof-of-concept) trials that can learn from early results, adjust enrollment or assignments as evidence accumulates, and move efficiently toward identifying which interventions work best for specific kinds of patients.

A central theme of the opportunity is precision medicine in a hard-to-treat population. The network is expected to stratify participants using asthma phenotypes (observable clinical patterns) and/or endotypes (biologically defined disease subtypes), and to incorporate predictive and monitoring biomarkers or biomarker profiles. In practice, that means the trials are intended to test targeted or personalized intervention strategies, not just one-size-fits-all treatments. The emphasis on predictive biomarkers suggests the network will try to identify up front who is more likely to respond to a given intervention, while monitoring biomarkers implies ongoing measurement during the trial to track response, safety, or early signs of exacerbation risk. The adaptive design component indicates the studies may use planned modifications such as response-adaptive randomization, dropping ineffective arms, enriching particular subgroups, or moving promising strategies forward more quickly, all within a controlled trial framework.

Structurally, PrecISE is described as a multi-site network made up of multiple Clinical Centers (CCs) plus one Data, Modeling, and Coordination Center (DMCC). This specific FOA (RFA-HL-17-009) solicits applications for the Clinical Centers, while a companion FOA (released in parallel) solicits the DMCC. The Clinical Centers are the front line for participant recruitment, clinical characterization, delivery of trial interventions, and collection of clinical outcomes and biospecimens according to network-wide protocols. The DMCC, by contrast, is intended to provide centralized coordination, data management, trial operations support, and advanced modeling and statistical support suited to sequential adaptive trial designs. Because this is a cooperative agreement (UG1), awardees should expect substantial scientific and programmatic involvement from NHLBI staff compared with a standard investigator-initiated grant, including active collaboration on study designs, protocol decisions, milestone tracking, and network governance.

Eligibility is broad and includes many types of U.S.-based organizations that can run clinical research at the required level. Eligible applicants include state, county, city, and 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; nonprofits with or without 501(c)(3) status (as long as they are not institutions of higher education, since those are listed separately); for-profit organizations (other than small businesses) and small businesses; and other eligible entities. The FOA also explicitly highlights additional applicant types such as 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, Indian/Native American Tribal Governments other than federally recognized entities, and U.S. territories or possessions. While it mentions non-domestic (non-U.S.) entities in the “other eligible applicants” list, the FOA then clarifies that non-domestic (non-U.S.) entities (foreign institutions) are not eligible to apply, and that non-domestic components of U.S. organizations are also not eligible to apply. At the same time, foreign components, as NIH defines them in the NIH Grants Policy Statement, are allowed, meaning a U.S. applicant may include certain foreign collaborations or performance elements when appropriately justified and compliant with NIH policy.

Administratively, the opportunity falls under the Health funding activity category and is associated with CFDA number 93.838. The agency is NIH, with NHLBI as the sponsoring institute. The original posting indicates a creation date of 2016-07-28 and an original closing date of 2016-12-28, which signals the historical application window for that specific announcement. The award instrument is listed as a cooperative agreement, reinforcing that funded Clinical Centers would be expected to operate as part of a tightly coordinated network rather than as fully independent trial sites. The description does not provide a stated award ceiling or number of expected awards in the supplied data, but the network model implies multiple Clinical Center awards plus a single separate award for the DMCC under the companion FOA.

In plain terms, this FOA was aiming to assemble a national, standardized, biomarker-driven clinical trial engine for severe and exacerbation-prone asthma. It sought Clinical Centers capable of enrolling and carefully characterizing complex asthma patients, implementing adaptive proof-of-concept trials of precision interventions, and working closely with a central coordination and data/modeling hub and with NHLBI leadership. The intended payoff is faster, more reliable identification of which therapies or intervention strategies work best for which biologically and clinically defined asthma subgroups, with the ultimate aim of reducing exacerbations and improving outcomes in patients who do not respond well to conventional approaches.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Clinical Centers for the NHLBI's Precision Interventions for Severe and/or Exacerbation Prone Asthma (PrecISE) Network (UG1)" 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 2016-12-28. (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.

Apply for RFA HL 17 009

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