Limited Competition: Data Coordinating Center (DCC) for Completion of Ongoing MFMU Network Protocols (U24 Clinical Trial Optional) | RFA HD 21 028

Opportunity Information: Apply for RFA HD 21 028

The grant opportunity titled "Limited Competition: Data Coordinating Center (DCC) for Completion of Ongoing MFMU Network Protocols (U24 Clinical Trial Optional)" (Funding Opportunity Number RFA-HD-21-028) is a National Institutes of Health cooperative agreement issued by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). It is a limited-competition announcement, meaning it is not broadly open to every possible applicant in the way many NIH opportunities are; instead, it is aimed at a narrower pool of institutions that are positioned to step into a very specific, high-responsibility role. The core purpose is to support a single organization that will function as the Data Coordinating Center for the Maternal-Fetal Medicine Units (MFMU) Network as the network finishes out ongoing protocols. In other words, the award is focused on coordinating, managing, and completing studies that are already in progress within a long-running, multi-site maternal-fetal research network, rather than launching a brand-new network from scratch.

At a program level, the MFMU Network is described as an ongoing multi-center research network that conducts both observational and interventional clinical studies using common protocols across participating sites. The scientific intent is practical and patient-centered: to generate strong, multi-site evidence that can improve maternal, fetal, and neonatal health outcomes. Because pregnancy-related research often requires large and diverse patient populations, consistent procedures, and careful safety oversight, the DCC role is central. The DCC typically serves as the operational hub that makes multi-site research function as a single coherent program by standardizing data collection, maintaining data quality, coordinating study operations, supporting regulatory compliance, and producing the analyses and reports that allow the network to reach valid conclusions. The title also notes "Clinical Trial Optional," which signals that the U24 mechanism can support work that includes clinical trials but does not require that every activity be a trial; given the network performs both observational and interventional work, the DCC must be capable of supporting either type.

The funding instrument is a cooperative agreement (U24). This is important because it implies substantial involvement by NIH/NICHD staff in the conduct of the project compared with a traditional grant. Under a cooperative agreement, the awardee does not simply receive funds and operate independently; instead, the work is carried out in partnership with the NIH, with shared responsibilities and ongoing collaboration. For a DCC, that usually means frequent coordination with NICHD program staff and network leadership, participation in network governance and meetings, alignment on protocol implementation, and responsiveness to NIH priorities around study completion, quality, and dissemination. The announcement explicitly frames the relationship as participation "with the NICHD" as the DCC, reinforcing that the DCC is expected to work closely with the federal sponsor while supporting the network sites executing the clinical protocols.

Administratively, this opportunity is listed as discretionary funding within the Health, Income Security and Social Services activity category, with CFDA number 93.865, and the agency is the National Institutes of Health. The opportunity was created on 2020-07-30 and the original closing date is 2020-09-04, indicating a relatively short application window typical of targeted or limited competitions. The provided listing does not specify an award ceiling or expected number of awards in the fields shown, so applicants would normally need to consult the full FOA text for budget expectations, project period, and whether NICHD anticipated a single DCC award or multiple awards.

Eligibility is primarily for U.S.-based organizations, and the announcement is clear about excluding foreign participation in several forms. Non-domestic (non-U.S.) entities (foreign institutions) 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. This effectively means the DCC must be domestic and the supported work must not include foreign components as part of the award structure. At the same time, the listing indicates a range of eligible applicant types, including categories such as independent school districts, public housing authorities/Indian housing authorities, and "others," and it also explicitly mentions additional eligible applicants such as Indian/Native American Tribal Governments (other than federally recognized), regional organizations, and U.S. territories or possessions. Practically, while those categories are technically eligible, the DCC responsibilities typically require substantial clinical research infrastructure, data management capability, biostatistics expertise, regulatory and privacy compliance systems, and experience coordinating multi-site clinical research, so the realistic applicant pool tends to be organizations with established clinical research coordinating capacity.

In plain terms, NICHD is seeking a capable U.S.-based institution to serve as the central data and operations backbone for the MFMU Network as it completes existing research studies. The awardee would be expected to ensure that data collected across many clinical sites are consistent, accurate, secure, and analysis-ready; to coordinate protocol implementation and study operations; and to help the network produce credible results that can translate into improvements in care for pregnant people and newborns. The limited-competition nature and cooperative agreement mechanism together suggest NICHD is prioritizing continuity, coordination, and successful completion of ongoing network protocols with close NIH involvement rather than open-ended exploratory work.

• The National Institutes of Health in the health, income security and social services sector is offering a public funding opportunity titled "Limited Competition: Data Coordinating Center (DCC) for Completion of Ongoing MFMU Network Protocols (U24 Clinical Trial Optional)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.865.
• This funding opportunity was created on 2020-07-30.
• Applicants must submit their applications by 2020-09-04. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Eligible applicants include: Independent school districts, Public housing authorities/Indian housing authorities, Others.

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