Allergy and Asthma Statistical and Clinical Coordinating Center (AA-SCCC) (U01 Clinical Trial Not Allowed) | RFA AI 22 054

Opportunity Information: Apply for RFA AI 22 054

The Allergy and Asthma Statistical and Clinical Coordinating Center (AA-SCCC) funding opportunity (RFA-AI-22-054) is a National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID) cooperative agreement intended to establish a central coordinating center that strengthens and streamlines NIAID-supported clinical research in allergic diseases and asthma. The core idea is that many allergy and asthma studies depend on consistent, high-quality trial operations, common data standards, rigorous statistics, and well-coordinated multicenter logistics. This award supports an organization that can serve as the hub for those functions so that multiple research networks and studies can be designed, launched, run, monitored, and analyzed efficiently and consistently.

The AA-SCCC is expected to provide end-to-end statistical and clinical coordination support across a broad portfolio of allergy and asthma research. That support typically includes assistance with protocol and study design, development of case report forms and data collection instruments, statistical analysis planning, randomization strategies (when applicable), database development and data management, quality assurance and quality control, safety and performance monitoring support, coordination of site activities, training and communications, and preparation of interim and final analyses and reports. The FOA emphasizes that the coordinating center is critical not just for running studies smoothly, but also for improving scientific rigor and interpretability through robust analytic methods, harmonized procedures, and consistent oversight across participating sites and projects.

A major focus of the AA-SCCC is support for NIAID-sponsored clinical research programs in allergy and asthma, specifically the Atopic Dermatitis Research Network, the Consortium for Food Allergy Research, the Childhood Asthma in Urban Settings Clinical Research Network, and the Immune Tolerance Network. In practice, this means the coordinating center must be capable of working across different disease areas and study designs, from trials focused on therapies and prevention strategies to mechanistic studies that probe immune pathways. The FOA also notes the AA-SCCC may provide support for investigator-initiated clinical trials (IICT) and other NIAID-funded clinical trial or clinical study activities, suggesting the center should be built to scale and adapt as NIAID priorities and study pipelines evolve.

The types of research the AA-SCCC is expected to support span a wide range. This includes clinical trials (even though the specific funding mechanism is labeled "Clinical Trial Not Allowed" for the coordinating center applicant, the center itself supports trials run by the networks and investigators), integrated studies of underlying mechanisms, and other clinical studies such as longitudinal observational cohorts and genetic studies. Another highlighted area is work to identify and validate surrogate endpoints and biomarkers, which often requires careful standardization of assays, data structures, and analytic plans to ensure results are credible and comparable across sites and studies.

The award uses a U01 cooperative agreement mechanism, which typically means substantial NIH program staff involvement compared to a standard research grant. In a cooperative agreement, the awardee runs the day-to-day coordinating center operations, while NIH/NIAID staff maintain an active partnership role in governance, prioritization, and oversight. Applicants generally need to be prepared to operate in a highly collaborative environment that includes multiple clinical sites, network leadership, NIH staff, and often external committees, with clear expectations around responsiveness, documentation, transparency, and adherence to agreed-upon policies and timelines.

Eligibility is broad and includes many domestic organization types: state, county, and city or township governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; tribal organizations that are not federally recognized; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status (other than institutions of higher education); for-profit organizations (other than small businesses); and small businesses. The FOA also explicitly calls out additional eligible applicant categories such as Alaska Native and Native Hawaiian Serving Institutions, AANAPISIs, Hispanic-serving Institutions, Historically Black Colleges and Universities, Tribally Controlled Colleges and Universities, faith-based or community-based organizations, eligible federal agencies, regional organizations, and U.S. territories or possessions. At the same time, it specifies that non-domestic (non-U.S.) entities and non-domestic components of U.S. organizations are not eligible to apply, although foreign components as defined by the NIH Grants Policy Statement are allowed, which typically means certain discrete project elements may be conducted abroad under NIH rules even though the applicant organization must be domestic.

Administratively, this is a discretionary funding opportunity in the health category (CFDA 93.855), sponsored by NIH, with an original closing date of November 30, 2022, and a creation date of August 9, 2022. The published summary does not provide an award ceiling or expected number of awards, so prospective applicants would normally look to the full FOA text and any NIH Guide notices for budget guidance, anticipated project period, and the intended scale of the coordinating center. Overall, the opportunity is aimed at building a high-capacity, experienced statistical and clinical operations hub that can support multiple NIAID allergy and asthma research efforts with consistent methods, strong governance, and reliable data and analytic infrastructure.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Allergy and Asthma Statistical and Clinical Coordinating Center (AA-SCCC) (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): 93.855.
• This funding opportunity was created on 2022-08-09.
• Applicants must submit their applications by 2022-11-30. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• 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.

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