Opportunity Information: Apply for RFA DK 18 512
The grant opportunity titled "Limited Competition: Follow-up on Subjects, Integrative Data Analysis and Measurement of Viral Antibodies in The Environmental Determinants of Diabetes in The Young Study (TEDDY) (U01 Clinical Trial Not Allowed)" is a National Institutes of Health (NIH) Funding Opportunity Announcement issued under the Department of Health and Human Services. It is designed as a highly targeted, limited-competition award meant to support the continuation and expansion of work already underway in the TEDDY study, which is a long-running epidemiological research effort focused on understanding environmental drivers of diabetes in children. The mechanism is a U01 cooperative agreement, meaning the NIH is expected to have substantial scientific and programmatic involvement alongside the awardee rather than serving only as a passive funder, and the announcement explicitly notes that a clinical trial is not allowed under this award.
A central feature of this FOA is that it invites only one application, and that application must come from the Program Director/Principal Investigator of the currently funded TEDDY Data Coordinating Center (DCC). In other words, the opportunity is intentionally restricted to the existing coordinating center team that has been involved since the consortium began, reflecting the reality that TEDDY data systems, biospecimen workflows, and longitudinal participant follow-up processes are complex and highly specialized. The DCC has played a foundational role in the study from the start, including contributions to study design and the acquisition, management, and organization of both data and biological samples. This FOA essentially aims to ensure continuity of that infrastructure so the study can keep tracking TEDDY participants and making full scientific use of the deeply characterized dataset and sample repository.
The work supported under this funding is twofold. First, it provides support for ongoing follow-up of children enrolled in TEDDY, which typically implies maintaining participant contact, managing longitudinal data collection, sustaining quality control and harmonization across sites, and keeping the study database and operational systems running smoothly. Long-term follow-up is particularly important in an epidemiological cohort like TEDDY because the scientific value increases as outcomes emerge over time and as early-life exposures can be linked to later biological and clinical endpoints. Second, the FOA explicitly enables funding for collaborators to conduct additional scientific analyses that leverage TEDDY resources, with a specific emphasis on two scientific areas: integrative analysis of multiple "omics" datasets and the measurement and analysis of viral antibodies from TEDDY biospecimens.
The "integrative data analysis" portion points toward combining diverse high-dimensional biological data types (for example, genomic, transcriptomic, proteomic, metabolomic, microbiome, and related datasets) with clinical, environmental, and behavioral measures collected in the cohort. The intent is typically to move beyond single-dataset findings and instead use multi-omic integration approaches that can identify pathways, signatures, and interactions that might contribute to diabetes development or progression. This often requires advanced coordination because omics datasets can differ in scale, sampling timepoints, lab platforms, preprocessing pipelines, and missingness patterns, and one of the DCC's core roles is to provide the governance, standardization, and analytic infrastructure needed to make such integration reliable and reproducible.
The viral antibody measurement and analysis component indicates an interest in characterizing immune responses to viral exposures using stored samples from TEDDY participants. Antibody profiling can help infer prior infections or exposure patterns and can be analyzed in relation to diabetes-related outcomes or intermediate biomarkers. In large prospective pediatric cohorts, these kinds of analyses can be used to test hypotheses about whether certain viral exposures, timing of infections, or immune response patterns are associated with increased or decreased risk. Because TEDDY has systematically collected and curated biospecimens over time, it provides a strong platform for this kind of serological work, but it also demands careful coordination around sample selection, assay methods, data integration, and interpretation, which again aligns with the DCC's coordinating mission.
Administratively, the opportunity is categorized as discretionary funding and uses the cooperative agreement instrument. It is listed under CFDA numbers 93.847 and 93.855, indicating its alignment with NIH program areas related to diabetes, digestive and kidney diseases, and broader health research. The eligible applicant type specified is "Public and State controlled institutions of higher education," consistent with the fact that the existing TEDDY DCC is housed within an academic setting. The announcement anticipates a single award (ExpectedAwards: 1) with an award ceiling of $9,000,000, reflecting the scale of work involved in sustaining a major international coordinating center and supporting associated collaborative scientific projects.
Key dates included in the listing show a creation date of March 25, 2019, and an original closing date of June 3, 2019, which signals that this was a time-limited competition intended to maintain seamless continuity of TEDDY operations. Overall, the FOA is best understood as a continuation-and-enhancement award for the existing TEDDY coordinating infrastructure, with added emphasis on modern integrative analytics and immune/viral exposure characterization, all leveraging the uniquely rich longitudinal data and biospecimen resources already built by the TEDDY Consortium.Apply for RFA DK 18 512
- The Department of Health and Human Services, National Institutes of Health in the food and nutrition, health sector is offering a public funding opportunity titled "Limited Competition: Follow-up on Subjects, Integrative Data Analysis and Measurement of Viral Antibodies 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 Mar 25, 2019.
- Applicants must submit their applications by Jun 03, 2019. (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 $9,000,000.00 in funding.
- The number of recipients for this funding is limited to 1 candidate(s).
- Eligible applicants include: Public and State controlled institutions of higher education.
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Frequently Asked Questions (FAQs)
What is the official title of this grant opportunity?
The opportunity is titled: "Limited Competition: Follow-up on Subjects, Integrative Data Analysis and Measurement of Viral Antibodies in The Environmental Determinants of Diabetes in The Young Study (TEDDY) (U01 Clinical Trial Not Allowed)."
Which agency is offering this funding opportunity?
This is a National Institutes of Health (NIH) Funding Opportunity Announcement (FOA) issued under the U.S. Department of Health and Human Services.
What is the main purpose of this FOA?
The FOA is designed to support the continuation and expansion of work already underway in the TEDDY study, a long-running epidemiological research effort focused on understanding environmental determinants of diabetes in children. The emphasis is on maintaining long-term follow-up and enabling additional analyses using TEDDY data and biospecimens.
Is this an open competition for any qualified organization?
No. This is a limited-competition opportunity that invites only one application.
Who is allowed to submit the application?
The FOA invites a single application, and it must be submitted by the Program Director/Principal Investigator (PD/PI) of the currently funded TEDDY Data Coordinating Center (DCC).
Why is the competition limited to the existing TEDDY Data Coordinating Center?
The FOA is restricted because TEDDY data systems, biospecimen workflows, and longitudinal participant follow-up processes are complex and highly specialized. The current DCC has been foundational to the consortium from the start, including study design contributions and the management and organization of data and biological samples. The intent is to ensure continuity of this infrastructure.
What funding mechanism does this FOA use?
The FOA uses the U01 cooperative agreement mechanism.
What does a U01 cooperative agreement imply for how the project is run?
A U01 cooperative agreement means NIH is expected to have substantial scientific and programmatic involvement with the awardee, rather than acting only as a passive funder.
Are clinical trials allowed under this FOA?
No. The FOA explicitly states "Clinical Trial Not Allowed."
What are the two main areas of work supported by this funding?
The supported work has two primary components: (1) ongoing follow-up of children enrolled in TEDDY, and (2) enabling collaborators to conduct additional scientific analyses leveraging TEDDY resources, with specific emphasis on integrative "omics" data analysis and the measurement/analysis of viral antibodies from TEDDY biospecimens.
What kinds of activities are included in "ongoing follow-up" of TEDDY participants?
Based on the description, ongoing follow-up typically includes maintaining participant contact, managing longitudinal data collection, sustaining quality control and harmonization across sites, and keeping the study database and operational systems running.
Why is long-term follow-up important for a study like TEDDY?
In an epidemiological cohort like TEDDY, the scientific value increases as outcomes emerge over time and as early-life exposures can be linked to later biological and clinical endpoints. Continued follow-up helps preserve and extend this value.
What does "integrative data analysis" mean in the context of this FOA?
Integrative data analysis refers to combining multiple high-dimensional biological datasets (for example, genomics, transcriptomics, proteomics, metabolomics, microbiome, and related datasets) with clinical, environmental, and behavioral measures collected in TEDDY. The intent is to support multi-omic integration approaches rather than isolated, single-dataset findings.
Why does integrative multi-omics analysis require coordination by a data coordinating center?
The FOA highlights that omics datasets can differ in scale, timepoints, lab platforms, preprocessing pipelines, and missingness patterns. The DCC role aligns with providing governance, standardization, and analytic infrastructure so integration is reliable and reproducible.
What is the FOA asking for regarding viral antibodies?
The FOA enables measurement and analysis of viral antibodies using stored TEDDY biospecimens to characterize immune responses and infer viral exposures over time.
How might viral antibody data be used scientifically within TEDDY?
As described, antibody profiling can help infer prior infections or exposure patterns and can be analyzed in relation to diabetes-related outcomes or intermediate biomarkers, including questions about timing of infections and patterns of immune response.
Does the FOA support work that uses TEDDY biospecimen samples?
Yes. A specific focus area is measurement and analysis of viral antibodies from TEDDY biospecimens, which relies on the cohort's systematically collected and curated sample repository.
How many awards does NIH expect to make under this FOA?
The FOA anticipates a single award (ExpectedAwards: 1).
What is the maximum (ceiling) award amount mentioned?
The award ceiling listed is $9,000,000.
What type of applicant organization is listed as eligible?
The eligible applicant type specified is "Public and State controlled institutions of higher education."
How is this opportunity categorized in terms of funding type?
It is categorized as discretionary funding.
What CFDA numbers are associated with this FOA?
The listing references CFDA numbers 93.847 and 93.855.
What do the dates in the listing indicate about the timing of this opportunity?
The listing shows a creation date of March 25, 2019, and an original closing date of June 3, 2019, indicating it was time-limited and intended to support seamless continuity of TEDDY operations.
In plain terms, how should someone understand the overall intent of this FOA?
It is best understood as a continuation-and-enhancement award for the existing TEDDY coordinating infrastructure, with added emphasis on modern integrative analytics and immune/viral exposure characterization, all leveraging TEDDY's longitudinal data and biospecimen resources.
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