Early Intervention to Promote Cardiovascular Health of Mothers and Children (ENRICH) Multisite Clinical Centers (Collaborative UG3/UH3 Clinical Trial Required) | RFA HL 22 007

Opportunity Information: Apply for RFA HL 22 007

The Early Intervention to Promote Cardiovascular Health of Mothers and Children (ENRICH) Multisite Clinical Centers funding opportunity (RFA-HL-22-007) is a National Institutes of Health (NIH) cooperative agreement designed to launch and run multisite clinical trials focused on improving cardiovascular health early in life, specifically for mothers and children. The program is built around a phased, milestone-driven structure that is meant to reduce risk and make sure large, expensive implementation trials only move forward when the early planning work shows the study is feasible, well-managed, and scientifically ready. This announcement is paired with a companion solicitation (RFA-HL-22-008) that funds a Data Coordinating Center (DCC), meaning awardees under this FOA are expected to work closely with a separately funded coordinating hub responsible for cross-site data and trial coordination.

The funding uses the UG3/UH3 bi-phasic cooperative agreement mechanism. In practical terms, the UG3 phase is a time-limited planning and start-up period of up to two years. During UG3, sites are expected to complete major readiness work such as finalizing protocols, testing recruitment and retention strategies, running feasibility studies, and conducting pilot trials that prove the intervention and study procedures can realistically be carried out across multiple clinical centers. The second phase, UH3, is the full implementation phase and can last up to five additional years. Transition from UG3 to UH3 is not automatic; only projects that meet the pre-specified scientific and operational milestones, and satisfy NIH award requirements, can “graduate” into UH3. Because of this structure, applications must be written as an integrated two-phase plan, laying out exactly what will be accomplished in UG3 and how that work will support a rigorous, scalable UH3 clinical trial.

A central expectation of this opportunity is that applicants propose a true clinical trial and demonstrate they can run it well across multiple sites. Applications must include detailed plans for project management and governance, including how the multisite team will operate and communicate, how decisions will be made, and how the clinical centers will interface with the DCC. NIH also expects a strong, practical plan for participant recruitment and retention, since enrolling and keeping mothers and children in longitudinal research is often one of the biggest threats to trial success. Scientific conduct requirements are explicit: applicants must describe the trial design, randomization approach, and a defensible power analysis; specify the intervention and how it will be delivered consistently across sites; define outcomes and measurement methods; and provide a clear statistical analysis plan for interpreting results. In both UG3 and UH3 sections, applicants must propose concrete, performance-based milestones that can be tracked objectively, such as enrollment targets, retention benchmarks, protocol finalization deadlines, staff training completion, data quality thresholds, and pilot study decision points.

This is a cooperative agreement rather than a typical research grant, which signals a more hands-on partnership with NIH. Cooperative agreements generally involve substantial NIH scientific and programmatic involvement during the life of the award, particularly around milestone review, coordination across sites, and alignment with the larger ENRICH network infrastructure that includes the DCC. The milestone-driven nature is meant to keep the study on track and create clear accountability before expanding into the longer UH3 phase.

Eligibility is broad across U.S.-based organizations and includes many public and private entity types. Eligible applicants include state, county, city, township, and 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 and without 501(c)(3) status (excluding institutions of higher education in those categories); for-profit organizations (other than small businesses); small businesses; and other organizations that meet NIH eligibility rules. The FOA also highlights additional eligible 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 ones, and U.S. territories or possessions. At the same time, it clearly restricts foreign participation: non-U.S. entities are not eligible to apply, non-domestic components of U.S. organizations are not eligible, and foreign components (as defined by the NIH Grants Policy Statement) are not allowed.

Administratively, this is a discretionary NIH funding opportunity in the health category, using the cooperative agreement funding instrument type. It is associated with CFDA numbers 93.307, 93.313, 93.837, and 93.840. The source listing shows an original closing date of 2021-06-11 and a creation date of 2021-02-22. The notice does not specify an award ceiling or the expected number of awards in the provided excerpt, so applicants typically would need to consult the full FOA and NIH budget guidance to understand likely award sizes, scope expectations per site, and overall network structure.

Overall, ENRICH Multisite Clinical Centers is geared toward teams that can demonstrate both scientific strength and real-world operational readiness: the ability to recruit and retain mothers and children, deliver an intervention consistently, capture high-quality data across multiple locations, and meet measurable milestones that justify moving from a two-year planning and feasibility stage into a larger, longer implementation trial conducted in close coordination with an NIH-supported Data Coordinating Center.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Early Intervention to Promote Cardiovascular Health of Mothers and Children (ENRICH) Multisite Clinical Centers (Collaborative UG3/UH3 Clinical Trial Required)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.307, 93.313, 93.837, 93.840.
• This funding opportunity was created on 2021-02-22.
• Applicants must submit their applications by 2021-06-11. (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 22 007

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