Federated Biobanking resource for the Down Syndrome Cohort Study Program (DS-CDP) across the lifespan for the INCLUDE Project (U24 Clinical Trial Not Allowed) | RFA OD 24 004

Opportunity Information: Apply for RFA OD 24 004

The NIH funding opportunity RFA-OD-24-004 calls for building a federated biobanking resource to support the Down Syndrome Cohort Study Program (DS-CDP) across the lifespan under the INCLUDE Project. At its core, this NOFO is about putting in place a practical, well-governed infrastructure that makes it easier to coordinate how biospecimens from people with Down syndrome are collected, processed, tracked, stored, and shared for research. The intent is not simply to create another standalone biobank, but to connect and harmonize biospecimen activities across multiple sites and existing repositories so researchers can more efficiently study health conditions that commonly co-occur with Down syndrome over time.

The program is designed to leverage and extend prior NIH investments, especially the INCLUDE Project and the INCLUDE Data Coordinating Center (DCC), as well as NIH-supported Down syndrome biospecimen repositories that already exist. In other words, NIH is signaling that there is already a developing ecosystem of cohort research sites, coordinating centers, and repositories, and this award is meant to provide the glue that ties biospecimen operations together. The federated model implies a networked approach in which specimens and associated data may remain at contributing repositories or sites while still being discoverable and accessible through common standards, shared governance, and coordinated procedures. The overall goal is to make biospecimen materials easier to find, request, and use in scientifically rigorous ways, while maintaining consistent quality and protecting participants.

This biobanking resource is positioned as a companion to other DS-CDP components, specifically the Down Syndrome Cohort Research Sites (DS-CRS) and the Down Syndrome Clinical Cohort Coordinating Centers (DS-4C). Those companion initiatives (referenced in RFA-OD-23-052 and RFA-OD-23-053) focus on building and coordinating the clinical cohort. This U24 resource, by contrast, focuses on the biospecimen side of the cohort enterprise: developing the operational backbone needed to manage specimens at scale across many sites and timepoints, and ensuring that specimens can be disseminated to qualified investigators to accelerate studies of co-occurring conditions throughout childhood, adulthood, and aging.

The award uses a cooperative agreement (U24) mechanism, which generally means substantial NIH involvement during the project. Rather than a purely investigator-driven grant where NIH has a hands-off role, a cooperative agreement typically involves active collaboration with NIH staff on milestones, coordination, and major decisions. The NOFO is also explicitly labeled "Clinical Trial Not Allowed," indicating applicants should not propose a clinical trial as part of this award. The emphasis is on infrastructure and resource development that enables research, not on testing interventions.

From a practical standpoint, the funded program is expected to cover the end-to-end workflow that makes biobanking useful in real-world research settings: coordinated specimen collection across the cohort, standardized processing and handling, inventory and tracking systems, quality management, governance for access and use, and mechanisms for distributing specimens to researchers in a timely and equitable way. Because this is tied to the INCLUDE Project and a cohort program, the expectation is that biospecimens will be integrated with participant-level information managed through the broader program infrastructure, including alignment with the INCLUDE DCC where appropriate. A key value proposition is reducing fragmentation so that biospecimen resources are not siloed by institution, study, or geography, and instead can support a broad range of investigators studying Down syndrome-associated health outcomes.

The eligible applicant pool is broad and includes many types of U.S.-based organizations: state, county, city or township governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; nonprofit organizations (with or without 501(c)(3) status); for-profit entities (other than small businesses); small businesses; public housing authorities/Indian housing authorities; and Native American tribal governments (federally recognized) and tribal organizations (other than federally recognized tribal governments). The NOFO also highlights additional eligible applicant categories such as Alaska Native and Native Hawaiian Serving Institutions, AANAPISIs, Hispanic-serving Institutions, HBCUs, Tribally Controlled Colleges and Universities, faith-based or community-based organizations, regional organizations, eligible federal agencies, and U.S. territories or possessions. Foreign institutions (non-U.S. entities) are not eligible to apply as applicant organizations, but non-domestic components of U.S. organizations are allowed, and foreign components (as defined by NIH policy) are allowed, which matters for projects that may rely on specialized international capabilities while remaining U.S.-led.

Administratively, the sponsoring agency is the National Institutes of Health, the funding instrument is a cooperative agreement, and the opportunity is categorized as discretionary. The opportunity lists CFDA numbers 93.172, 93.847, 93.865, and 93.866, reflecting the NIH program authorities associated with this effort. The posted award ceiling is $3,750,000. The original closing date listed is 2023-12-15, and the opportunity was created on 2023-10-19. While the listing shows "ExpectedAwards:" without a value, the central takeaway is that NIH is funding a major national resource rather than a small, single-lab effort, and it is meant to function as an enabling platform for many downstream studies.

Overall, this NOFO is aimed at strengthening Down syndrome clinical research by making biospecimens easier to collect consistently across a lifespan cohort, easier to manage under common standards, and easier to share responsibly. By coordinating across existing NIH investments, the federated biobanking resource is meant to increase the scientific value of every collected sample, reduce duplication, and help researchers move faster on understanding and addressing the multiple health conditions that can affect individuals with Down syndrome.

• The National Institutes of Health in the food and nutrition, health, income security and social services sector is offering a public funding opportunity titled "Federated Biobanking resource for the Down Syndrome Cohort Study Program (DS-CDP) across the lifespan for the INCLUDE Project (U24 Clinical Trial Not Allowed)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.172, 93.847, 93.865, 93.866.
• This funding opportunity was created on 2023-10-19.
• Applicants must submit their applications by 2023-12-15. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Each selected applicant is eligible to receive up to $3,750,000.00 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 RFA OD 24 004

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