Opportunity Information: Apply for RFA HL 22 008
The Early Intervention to Promote Cardiovascular Health of Mothers and Children (ENRICH) Multisite Resource and Coordinating Center (U24 Clinical Trial Required) funding opportunity, RFA-HL-22-008, is a National Institutes of Health (NIH) cooperative agreement aimed at supporting a central resource and coordinating function for the ENRICH research program. The overarching purpose is to enable rigorous, multisite clinical trial work focused on early interventions that can improve cardiovascular health outcomes for mothers and children. In practice, this means funding a dedicated center that can help organize, align, and support the scientific and operational needs of a coordinated set of studies, with an emphasis on consistent methods, strong trial conduct, and reliable data generation across participating sites.
This opportunity is structured to run in parallel with a companion funding announcement, RFA-HL-22-007, and it is explicitly designed to operate alongside another companion announcement that supports a Data Coordinating Center (DCC). Together, these parallel awards are intended to create an integrated infrastructure for a multisite research effort, where the resource and coordinating center role complements the DCC role so the overall program can function smoothly. The cooperative agreement format signals substantial NIH involvement during the project, which typically includes active collaboration on planning, oversight of milestones, and coordination expectations that go beyond a standard research grant.
A key feature of the program is its use of a bi-phasic, milestone-driven UG3/UH3 framework. The first phase (UG3) functions as a time-limited planning and readiness stage that can last up to two years. During this period, awardees are expected to complete feasibility studies and pilot clinical trial activities that demonstrate the intervention approach and trial procedures can be executed successfully. The second phase (UH3) is the larger-scale implementation phase that may extend up to five additional years, but it is not automatic. Transition from UG3 to UH3 depends on meeting predefined scientific and operational milestones and satisfying all UG3 award requirements. This structure is designed to reduce risk by requiring concrete proof of readiness before investing in full implementation.
Applications must cover both phases from the start, meaning applicants need to lay out a coherent end-to-end plan that begins with feasibility and pilots and then clearly scales into implementation if milestones are achieved. The FOA emphasizes that applicants must provide detailed plans for project management and governance, along with practical strategies for participant recruitment and retention. Because this is a clinical trial-required opportunity, the application is expected to show that the team can conduct a high-quality trial, including specifying the study design, how randomization will be performed where applicable, and how sample size and statistical power are justified. It also requires clear descriptions of the intervention approach, what will be measured, how outcomes and data elements will be collected, and how statistical analyses will be performed to interpret results.
Milestones are central to both phases, and they are expected to be performance-based rather than aspirational. In other words, the application should define measurable benchmarks and decision points that demonstrate progress, such as successful site activation, recruitment thresholds, data quality targets, adherence to protocol, completion of pilot endpoints, and readiness indicators for launching the full implementation phase. These milestones serve as the basis for NIH’s go/no-go decisions about whether the work is on track and whether a UG3 project can transition to UH3 support.
From an eligibility standpoint, the FOA is broadly open to many organization types, including state, county, and local governments; public and private institutions of higher education; federally recognized tribal governments and other tribal organizations; public housing authorities/Indian housing authorities; nonprofit organizations with or without 501(c)(3) status; for-profit organizations (other than small businesses) as well as small businesses; and other entities as clarified in the full announcement. The sponsoring agency is the U.S. Department of Health and Human Services through NIH, and the activity falls under health-related funding categories associated with CFDA numbers 93.307, 93.313, 93.837, and 93.840. The announcement lists an expected single award, reflecting a centralized coordination model where one funded center provides shared resources and coordination for the broader ENRICH program.
Administratively, the opportunity was created on February 22, 2021, with an original closing date of June 11, 2021, and it is issued as a cooperative agreement rather than a traditional grant, reinforcing the expectation of close collaboration with NIH program staff. While an award ceiling is listed as 0 in the provided data fields (often indicating that a specific cap is not stated in that summary field), applicants would normally need to consult the full FOA text for budget expectations, scope assumptions, and any cost limitations or justifications required. Overall, the opportunity is best understood as funding the organizing backbone for a milestone-driven, multisite clinical trial effort focused on early-life and maternal interventions to improve cardiovascular health trajectories.Apply for RFA HL 22 008
- The Department of Health and Human Services, 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 Resource and Coordinating Center (U24 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 Feb 22, 2021.
- Applicants must submit their applications by Jun 11, 2021. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The number of recipients for this funding is limited to 1 candidate(s).
- 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 (see text field entitled Additional Information on Eligibility for clarification).
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FAQs: ENRICH Multisite Resource and Coordinating Center (U24 Clinical Trial Required) - RFA-HL-22-008
What is the ENRICH Multisite Resource and Coordinating Center funding opportunity?
RFA-HL-22-008 is an NIH cooperative agreement that supports a centralized resource and coordinating function for the ENRICH research program. The goal is to enable rigorous, multisite clinical trial work on early interventions that improve cardiovascular health outcomes for mothers and children by providing consistent methods, strong trial conduct, and reliable data generation across participating sites.
What does this award fund in practice?
This award funds a dedicated center that helps organize, align, and support the scientific and operational needs of a coordinated set of ENRICH studies. The center is intended to serve as the organizing backbone for a multisite effort, supporting coordination, consistency, and execution across sites rather than operating as a single-site study.
Which agency is sponsoring this opportunity?
The sponsoring agency is the U.S. Department of Health and Human Services through the National Institutes of Health (NIH).
What is the funding mechanism and what does it imply?
The mechanism is a cooperative agreement. This signals substantial NIH involvement during the project, typically including active collaboration on planning, oversight of milestones, and coordination expectations beyond what is common in a traditional research grant.
Is a clinical trial required under this opportunity?
Yes. The opportunity is explicitly labeled "Clinical Trial Required," and applications are expected to demonstrate the team can conduct a high-quality clinical trial, including design, randomization (where applicable), sample size and power justification, outcome measurement, data collection, and statistical analysis plans.
How does this FOA relate to other ENRICH funding announcements?
This opportunity is designed to run in parallel with a companion funding announcement, RFA-HL-22-007, and it is also designed to operate alongside another companion announcement that supports a Data Coordinating Center (DCC). Together, these parallel awards are intended to create an integrated infrastructure for multisite ENRICH research, with complementary roles between the resource/coordinating center and the DCC.
What is the UG3/UH3 bi-phasic, milestone-driven framework described in the opportunity?
The program uses a two-phase UG3/UH3 structure. The UG3 phase is a time-limited planning and readiness stage (up to two years) focused on feasibility studies and pilot clinical trial activities. The UH3 phase is the larger-scale implementation stage (up to five additional years) that may follow only if predefined scientific and operational milestones are met and all UG3 requirements are satisfied.
How long can the UG3 phase last, and what is it meant to accomplish?
The UG3 phase can last up to two years. It is intended to support planning and readiness activities, including feasibility studies and pilot clinical trial work, to show the intervention approach and trial procedures can be executed successfully.
How long can the UH3 phase last, and is it guaranteed?
The UH3 phase may extend up to five additional years, but it is not automatic. Transition from UG3 to UH3 depends on meeting predefined milestones and satisfying all UG3 award requirements, with NIH making go/no-go decisions based on performance.
Do applicants need to propose both UG3 and UH3 phases in the initial application?
Yes. Applications must cover both phases from the start. Applicants are expected to present an end-to-end plan that begins with feasibility and pilot work and then clearly scales into implementation if milestones are achieved.
What are milestones and why are they so central to this program?
Milestones are measurable, performance-based benchmarks and decision points used to track progress and determine readiness to move forward. They form the basis for NIH go/no-go decisions, including whether a UG3 project transitions to UH3 support.
What kinds of milestones are expected?
The opportunity emphasizes practical, measurable milestones rather than aspirational statements. Examples described include successful site activation, recruitment thresholds, data quality targets, protocol adherence, completion of pilot endpoints, and readiness indicators for launching the full implementation phase.
What governance and management elements are emphasized in the application?
The FOA emphasizes detailed plans for project management and governance, along with operational strategies that support coordinated trial conduct across sites, including how the work will be organized and overseen in a multisite environment.
What does the FOA say about participant recruitment and retention?
Applicants are expected to provide practical strategies for participant recruitment and retention, reflecting the program focus on conducting a high-quality, multisite clinical trial with reliable enrollment and follow-up.
What clinical trial details are expected to be included in the application?
The application is expected to specify the study design, how randomization will be performed where applicable, how sample size and statistical power are justified, the intervention approach, what will be measured, how outcomes and data elements will be collected, and how statistical analyses will be performed.
What is the overarching research focus of the ENRICH program described here?
The research focus is early interventions aimed at improving cardiovascular health outcomes for mothers and children, with an emphasis on shaping cardiovascular health trajectories through early-life and maternal interventions.
Who is eligible to apply?
Eligibility is broadly open to many organization types, including state, county, and local governments; public and private institutions of higher education; federally recognized tribal governments and other tribal organizations; public housing authorities/Indian housing authorities; nonprofit organizations with or without 501(c)(3) status; for-profit organizations (other than small businesses) as well as small businesses; and other entities as clarified in the full announcement.
How many awards are expected to be made?
The announcement lists an expected single award, reflecting a centralized coordination model in which one funded center provides shared resources and coordination for the broader ENRICH program.
What are the relevant CFDA numbers associated with this opportunity?
The activity is associated with health-related CFDA numbers 93.307, 93.313, 93.837, and 93.840.
What are the key dates mentioned for this opportunity?
The opportunity was created on February 22, 2021, with an original closing date of June 11, 2021.
Is there a stated budget cap or award ceiling?
An award ceiling is listed as 0 in the provided summary fields, which often indicates that a specific cap is not stated in that summary. Budget expectations, scope assumptions, and any cost limitations would typically need to be verified in the full FOA text.
What does "multisite" mean in the context of this opportunity?
In this context, "multisite" refers to clinical trial work conducted across multiple participating sites, with the funded center supporting coordination, alignment of methods, and consistent operational and scientific execution across those sites.
How does this center complement the Data Coordinating Center (DCC)?
The FOA describes an integrated infrastructure where this resource and coordinating center role complements a companion-supported Data Coordinating Center (DCC), so the overall multisite program can function smoothly with coordinated operations and reliable data generation.
What is the main reason for using a milestone-driven approach?
The milestone-driven UG3/UH3 design is intended to reduce risk by requiring concrete proof of readiness during the UG3 phase before committing resources to the larger-scale UH3 implementation phase.
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