Limited Competition: Continued Follow-up of Subjects and Initiation of a Second Case-control Cohort in The Environmental Determinants of Diabetes in The Young Study (TEDDY) (U01 Clinical Trial Not Allowed) | RFA DK 20 503

Opportunity Information: Apply for RFA DK 20 503

The National Institutes of Health (NIH) funding opportunity titled "Limited Competition: Continued Follow-up of Subjects and Initiation of a Second Case-control Cohort in The Environmental Determinants of Diabetes in The Young Study (TEDDY) (U01 Clinical Trial Not Allowed)" is a narrowly targeted request for a single application tied to the ongoing TEDDY research consortium. TEDDY is a long-running epidemiologic study focused on identifying environmental factors that contribute to diabetes development in children, and this announcement is designed to keep the study infrastructure operating while expanding specific analytical work using the already collected cohort data and biospecimens.

This is a limited competition FOA, meaning NIH is not seeking multiple competing proposals from the broader research community. Instead, it specifically invites one application from the Program Director/Principal Investigator of the current TEDDY Data Coordinating Center (DCC). The DCC is central to the TEDDY Consortium because it has been involved since the beginning of the study in core activities such as study design support, coordination across sites, and the acquisition, tracking, management, and quality control of both data and biosamples. The FOA essentially recognizes that the TEDDY DCC holds the operational knowledge and systems needed to continue the study without disruption, which is why eligibility is constrained.

The main purpose of the award is to provide continued support for the TEDDY DCC to keep following the TEDDY children over time. Continued follow-up is crucial in longitudinal studies like this because the value of the cohort increases as participants age and more health outcomes and exposures can be observed and linked. Maintaining continuity also protects the integrity of long-term datasets and ensures that samples and information collected under consistent protocols remain usable for later analyses.

In addition to supporting ongoing follow-up, the announcement explicitly allows funding that supports collaborators working with TEDDY resources in two highlighted scientific areas. First, it supports studies that integrate "omics" data, which generally refers to large-scale biological datasets such as genomics, transcriptomics, proteomics, metabolomics, and microbiomics. Integration of these layers is intended to help researchers connect environmental exposures and biological pathways with diabetes-related outcomes more precisely than any single data type could on its own. Second, it supports the measurement and analysis of viral antibodies using samples from TEDDY subjects, reflecting the longstanding hypothesis that viral exposures or immune responses to infections may play a role in triggering or accelerating diabetes-related autoimmunity in susceptible children.

The funding mechanism is a U01 cooperative agreement, which generally means NIH expects substantial programmatic involvement with the awardee compared with a standard research grant. In practice, cooperative agreements often involve close coordination on milestones, data sharing expectations, oversight, and consortium-style governance. The FOA is also marked "Clinical Trial Not Allowed," indicating the supported work should not be proposed as a prospective interventional clinical trial. The emphasis is on continued observational follow-up and analyses using cohort data and stored specimens rather than testing interventions.

Key administrative details included in the source information are that this opportunity is categorized as discretionary funding and is administered by NIH. The Funding Opportunity Number is RFA-DK-20-503, and the activity aligns with NIH areas related to diabetes, digestion, and kidney diseases. It lists CFDA numbers 93.847 and 93.855, which are NIH assistance listings often associated with diabetes and related metabolic disease research programs. The original closing date was 2020-08-13, and the FOA was created on 2020-05-15. The award ceiling and expected number of awards are not specified in the provided text, but the narrative makes clear that the intent is to support a single application from the existing TEDDY DCC leadership.

Eligibility language in the announcement reinforces how restricted the competition is while still acknowledging certain organizational categories in general NIH eligibility terms. The FOA states that other eligible applicants can include faith-based or community-based organizations, regional organizations, and U.S. territories or possessions, but it also clearly states that non-domestic (non-U.S.) entities (foreign institutions) are not eligible to apply and that non-domestic components of U.S. organizations are not eligible to apply. At the same time, it notes that "foreign components," as defined by the NIH Grants Policy Statement, are allowed, which typically means a U.S. applicant can include certain types of international collaboration or performance sites if they meet NIH definitions and are justified, even though a foreign institution cannot be the primary applicant.

Overall, this FOA is best understood as a continuation and targeted enhancement of an existing major longitudinal cohort program. It is meant to preserve the TEDDY study's long-term follow-up capacity through its established Data Coordinating Center while enabling deeper, modern analyses of immune and molecular data, including integrated omics approaches and viral antibody profiling, using the unique and valuable samples and data TEDDY has collected over many years.

• The National Institutes of Health in the food and nutrition, health sector is offering a public funding opportunity titled "Limited Competition: Continued Follow-up of Subjects and Initiation of a Second Case-control Cohort in The Environmental Determinants of Diabetes in The Young Study (TEDDY) (U01 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): 93.847, 93.855.
• This funding opportunity was created on 2020-05-15.
• Applicants must submit their applications by 2020-08-13. (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, Native American tribal organizations (other than Federally recognized tribal governments), Others.

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