Leveraging Network Infrastructure to Conduct Innovative Research for Women, Children, Pregnant and Lactating Individuals, and Persons with Disabilities (UG3/UH3 - Clinical Trial Optional) | PAR 25 311

Opportunity Information: Apply for PAR 25 311

This funding opportunity (PAR 25-311) from the National Institutes of Health, through NICHD, is designed to help investigators run innovative, multisite clinical research by taking advantage of existing NICHD clinical research Network infrastructure. The scientific focus is broad but clearly centered on populations that fall within NICHDs mission and network strengths: infants and children, women, pregnant and lactating individuals, and persons with disabilities. Projects can be either clinical trials or observational studies, and the overall intent is to use established network capabilities (including coordinated sites and centralized data systems) as a ready-made platform to test new investigator-driven ideas that benefit these priority groups.

The award uses a two-stage, milestone-driven structure known as UG3/UH3. The first stage (UG3) is a start-up phase meant for planning and launch activities that must be completed before a complex multisite study can enroll and operate at scale. During UG3, teams typically finalize protocols and manuals of procedures, lock down recruitment and retention plans, complete regulatory and ethics preparations, stand up data capture and quality-control workflows, and confirm site readiness. The application must include clear specific aims and measurable milestones for this UG3 period. If the UG3 milestones are met, NICHD will administratively consider and prioritize the project for transition into the second stage (UH3), which supports full enrollment and implementation of the trial or observational study across the participating sites. In practical terms, the UH3 phase is where the study conducts active recruitment, collects outcomes, monitors safety as applicable, and carries out the full operational plan across the network.

A defining feature of this NOFO is that applications must be investigator-initiated and submitted as multi-Project Director/Principal Investigator (multi-PD/PI) cooperative agreement applications. They must also be submitted in conjunction with the relevant NICHD-supported Network Data Coordinating Center (DCC), or an equivalent arrangement as determined acceptable by NICHD. This requirement signals that NICHD expects the study to be tightly integrated with network operations and data coordination from the start, rather than treating the DCC as an afterthought. Because the mechanism is a cooperative agreement, applicants should expect substantial NIH program involvement compared with a standard grant, especially around milestone assessment, network coordination, and performance oversight.

Eligible applicants span a wide range of U.S.-based organizations, reflecting the goal of enabling broad participation while still anchoring studies within NICHD network infrastructure. Eligible entities include state, county, city, and special district governments; independent school districts; public housing authorities; federally recognized tribal governments and other tribal organizations; public and private institutions of higher education; nonprofits with or without 501(c)(3) status; for-profit organizations (other than small businesses) as well as small businesses; and other organizations that meet NIH eligibility rules. The NOFO also highlights several institution types and community-facing organizations as eligible, including Alaska Native and Native Hawaiian Serving Institutions, AANAPISISs, Hispanic-serving institutions, Historically Black Colleges and Universities, Tribally Controlled Colleges and Universities, faith-based or community-based organizations, regional organizations, and U.S. territories or possessions. Despite the broad list, non-U.S. (foreign) organizations are not eligible to apply under this opportunity.

From an administrative perspective, the funding instrument is a cooperative agreement, and the activity category is Health, Income Security and Social Services. The CFDA numbers associated with the opportunity are 93.313 and 93.865. The opportunity was created on December 16, 2024, and lists an original closing date of November 15, 2027. The award ceiling is noted as $6,250,000, indicating NICHD anticipates potentially large, resource-intensive multisite projects that can make full use of network capabilities. The expected number of awards is not specified in the provided listing, which often means the institute will decide based on application volume, merit, and available funds.

Overall, this NOFO is best understood as a pathway for experienced clinical researchers, working in partnership with NICHD-supported networks and their DCCs, to move efficiently from rigorous start-up planning to real-world multisite execution. The UG3/UH3 structure is meant to reduce risk by requiring teams to prove feasibility and readiness through concrete early milestones before NIH commits to full-scale enrollment and implementation.

• The National Institutes of Health in the health, income security and social services sector is offering a public funding opportunity titled "Leveraging Network Infrastructure to Conduct Innovative Research for Women, Children, Pregnant and Lactating Individuals, and Persons with Disabilities (UG3/UH3 - Clinical Trial Optional)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.313, 93.865.
• This funding opportunity was created on 2024-12-16.
• Applicants must submit their applications by 2027-11-15.
• Each selected applicant is eligible to receive up to $6,250,000.00 in funding.
• 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 PAR 25 311

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