National Institute of Allergy and Infectious Diseases (NIAID) Clinical Data and Safety Management Center (CDSMC) (U01 Clinical Trial Not Allowed) | RFA AI 22 058

Opportunity Information: Apply for RFA AI 22 058

This funding opportunity, RFA-AI-22-058, is a National Institutes of Health (NIH) National Institute of Allergy and Infectious Diseases (NIAID) solicitation to establish a Clinical Data and Safety Management Center (CDSMC) through a U01 cooperative agreement mechanism. The center is meant to function as a shared, program-wide resource that provides essential infrastructure and operational support for NIAID-funded clinical research portfolios focused on immune-mediated diseases, specifically in asthma and allergic diseases, autoimmune diseases, and transplantation. Although the work supports clinical trials and other human studies, the notice is explicitly labeled "Clinical Trial Not Allowed" for the applicant organization under this award, meaning the funded activity is intended to provide enabling and coordinating services rather than to run an applicant-led clinical trial as the primary project.

At its core, the CDSMC is expected to deliver a broad set of critical services that help NIAID-supported studies operate safely, consistently, and efficiently across multiple projects and sites. The FOA emphasizes three main functional areas. First is data management and processing, which typically includes building and maintaining data capture systems, ensuring data quality, standardization, validation, cleaning, and producing datasets and reports that can be used by investigators and NIAID for ongoing monitoring and analysis. Second is safety and pharmacovigilance management and processing, which generally covers intake and reconciliation of adverse event information, safety reporting workflows, regulatory-compliant tracking, case processing, and generating safety summaries that support oversight bodies and NIAID program staff. Third is sample tracking systems, meaning the center should be capable of tracking biospecimens from collection through shipment, receipt, storage, and use, preserving chain-of-custody and ensuring that specimen data are properly linked to clinical and laboratory metadata. Collectively, these services are intended to support NIAID clinical trials, mechanistic studies embedded within clinical research, and a variety of clinical study designs such as longitudinal cohorts and genetic studies, as well as studies focused on identifying and validating surrogate endpoints or biomarkers relevant to immune-mediated disease.

The cooperative agreement structure is important because it signals that NIAID expects to have substantial scientific and/or programmatic involvement in the work. In practice, that usually means the awardee operates the center in close coordination with NIAID, follows NIAID-directed priorities and timelines, and integrates processes with multiple NIAID-funded networks, investigators, and study teams. The CDSMC is therefore positioned less like a single independent research project and more like an operational hub that supports many NIAID-sponsored efforts, often requiring strong governance, stakeholder communication, documentation practices, and the ability to scale services across different protocols and therapeutic areas within the immune-mediated disease space.

Eligibility is broad and includes many types of domestic U.S. entities: state, county, and local 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 governments; 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 highlights additional eligible applicant categories such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, eligible federal agencies, regional organizations, and U.S. territories or possessions. At the same time, the opportunity restricts foreign participation in specific ways: non-domestic (non-U.S.) entities are not eligible to apply as the applicant organization, and non-domestic components of U.S. organizations are not eligible to apply. However, "foreign components" as defined by the NIH Grants Policy Statement are allowed, which generally means a U.S. applicant may include certain foreign performance elements or collaborations if they meet NIH definitions and are appropriately justified and approved.

Administratively, this is a discretionary health funding opportunity under CFDA 93.855, with an original closing date of November 30, 2022, and a creation date of August 9, 2022. The published excerpt does not provide an award ceiling or expected number of awards, so applicants would normally need to consult the full FOA text for budget limits, project period, detailed requirements, review criteria, and the specific deliverables and milestones NIAID expects from the CDSMC. Overall, the grant is aimed at building and operating a centralized capability that strengthens the quality, safety oversight, and specimen accountability of NIAID-supported clinical research in key immune-related disease areas, ensuring consistent data standards and robust pharmacovigilance across a diverse set of studies.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "National Institute of Allergy and Infectious Diseases (NIAID) Clinical Data and Safety Management Center (CDSMC) (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.

Apply for RFA AI 22 058

[Watch] Creating a grant proposal using the step-by-step wizard inside the applicant portal: