Opportunity Information: Apply for RFA DD 21 002
This grant opportunity, titled "Characterizing the Natural History of Fragile X Syndrome to Inform the Development of Intervention Outcome Measures" (RFA DD 21 002), is a CDC-funded cooperative agreement focused on improving how fragile X syndrome (FXS) is understood and measured over time in real-world clinical populations. The central aim is to generate stronger, more practical evidence about the natural history of FXS in childhood and adolescence, and to identify outcome measures that are meaningful for individuals with FXS and their families. In plain terms, the project is meant to clarify how cognition, behavior, daily functioning, and related health indicators tend to develop and change for young people with full-mutation FXS, including those who also have autism spectrum disorder (ASD), so future interventions and clinical trials can use outcome measures that actually capture relevant changes.
The funded work is expected to enroll and assess children and adolescents ages 6 through 19 years who have full-mutation FXS. The opportunity allows inclusion of both newly recruited participants and individuals already enrolled in the Fragile X Online Registry with Accessible Research Database (FORWARD). FORWARD is described as a national patient registry drawn from FXS specialty clinics that participate in the Fragile X Clinical and Research Consortium, meaning the project is intended to build on an existing network of clinics and an established data infrastructure rather than starting from scratch. A key feature of the NOFO is its emphasis on in-person, standardized assessments, suggesting the CDC is prioritizing high-quality, comparable measurement across participants and sites.
The data collection priorities center on characterizing cognitive abilities, behavioral profiles, and adaptive skills, along with other indicators of functioning in individuals with FXS. This points to a broad functional picture rather than a narrow focus on a single symptom domain. The intended deliverable is not just descriptive epidemiology, but information that helps define and refine intervention outcome measures. That implies the study should help answer questions like which measures are sensitive to meaningful change, which domains best reflect daily-life impact, and how outcomes vary across subgroups such as FXS with ASD versus FXS without ASD.
Another major element is coordination with the CDC's Study to Explore Early Development (SEED) Follow-up Study (RFA-DD21-001). The NOFO highlights planned alignment of standardized in-person behavioral and functional assessments, plus follow-up telephone survey questionnaires, to enable comparisons between the FXS population and groups with related and commonly co-occurring conditions, especially ASD and developmental delay. This coordination is important because it improves interpretability: it can help distinguish what is more specific to FXS versus what overlaps with broader neurodevelopmental disability profiles, and it supports cross-condition benchmarking of health and functional outcomes.
From an applicant and operations standpoint, the NOFO permits different recruitment structures. Applicants can propose recruiting participants from a single FORWARD clinic or from multiple FORWARD clinics, as long as the principal investigator can document data sharing and collaboration agreements. That requirement signals that multi-site efforts are welcome but must be backed by clear governance and coordination plans to ensure consistent data collection and appropriate sharing of information across partners.
Administratively, this is a discretionary funding opportunity using a cooperative agreement mechanism, which typically means the CDC anticipates substantial involvement in the project beyond standard grant oversight (for example, collaborative planning, harmonization of methods, or coordinated milestones). It falls under a health funding category (CFDA 93.073) and is open to a wide range of eligible applicants, described as unrestricted subject to any additional eligibility details in the full notice. The award ceiling is $800,000, with one expected award, indicating the CDC planned to fund a single lead effort to carry out this coordinated research. The opportunity was posted November 5, 2020, with an original application due date of January 11, 2021 (11:59 p.m. ET).
Overall, the opportunity is designed to strengthen the evidence base for how FXS presents and changes across late childhood through adolescence, while simultaneously improving the field's ability to measure outcomes that matter for intervention development. By leveraging FORWARD's clinic-based registry and aligning methods with SEED follow-up efforts, the project is positioned to produce standardized, comparable data that can support better clinical trial endpoints, more meaningful tracking of functional progress, and clearer comparisons between FXS and closely related developmental conditions.Apply for RFA DD 21 002
- The Department of Health and Human Services, Centers for Disease Control and Prevention - ERA in the health sector is offering a public funding opportunity titled "Characterizing the Natural History of Fragile X Syndrome to Inform the Development of Intervention Outcome Measures" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.073.
- This funding opportunity was created on Nov 05, 2020.
- Applicants must submit their applications by Jan 11, 2021 Electronically submitted applications must be submitted no later than 1159 p.m., ET, on the listed application due date.. (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 $800,000.00 in funding.
- The number of recipients for this funding is limited to 1 candidate(s).
- Eligible applicants include: Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled Additional Information on Eligibility.
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