Consortium for Food Allergy Research: Leadership Center (UM1 Clinical Trial Required) | RFA AI 22 077

Opportunity Information: Apply for RFA AI 22 077

The National Institutes of Health, through the National Institute of Allergy and Infectious Diseases (NIAID), issued a discretionary funding opportunity (RFA-AI-22-077) to support the Leadership Center for the Consortium for Food Allergy Research (CoFAR). This award uses a cooperative agreement mechanism (UM1) and explicitly requires a clinical trial component, meaning the funded Leadership Center is expected to be directly involved in the planning and oversight of clinical trials as part of its core responsibilities, with NIH/NIAID having substantial programmatic involvement typical of cooperative agreements. The overall goal is to provide the central leadership and coordinating hub that sets the scientific direction for the entire CoFAR network and ensures that network-wide clinical research is designed, prioritized, and managed in a way that accelerates progress in food allergy prevention, diagnosis, and treatment.

At the heart of the opportunity is the expectation that the CoFAR Leadership Center will define the consortium-wide research strategy and drive the design and oversight of cutting-edge clinical trials and clinical studies. The scientific scope is broad but clearly targeted: advancing prevention and management strategies and improving understanding of disease origins and pathophysiology across several priority conditions. These include IgE-mediated food allergy (the classic immediate-type allergic reactions to foods), Alpha-Gal Syndrome (a tick-associated, IgE-mediated allergy to mammalian meat or products containing alpha-gal), Food Protein-Induced Enterocolitis Syndrome or FPIES (a typically non-IgE-mediated food allergy syndrome characterized by delayed gastrointestinal symptoms), and Eosinophilic Esophagitis or EoE (a chronic immune-mediated disease of the esophagus often linked to food triggers). The Leadership Center is therefore positioned not only to coordinate studies, but also to shape the field by selecting the most impactful questions, developing rigorous protocols, and standardizing approaches that allow results to be compared and combined across sites.

A key operational feature is how the Leadership Center interacts with the CoFAR Clinical Research Centers (CRCs). The Leadership Center is expected to work closely and collaboratively with the CRCs to select and implement all CoFAR network-wide clinical trials and studies. In practical terms, that means the Leadership Center leads network planning, harmonization, and oversight, while the CRCs carry primary responsibility for executing the trials and studies on the ground, including participant recruitment, site-level conduct, and local implementation. This division of labor is meant to create a unified national research program where the central hub ensures consistency, quality, and strategic alignment, and the clinical sites deliver the operational capacity needed to run complex multi-site research efficiently and safely.

Eligibility is intentionally broad, reflecting NIH norms and an effort to include a wide range of institutions and communities. Eligible applicants include various levels of U.S. government entities (state, county, city/township, and 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, and other tribal organizations. The opportunity also allows participation from nonprofits (both 501(c)(3) and non-501(c)(3), excluding those that are institutions of higher education in those categories), for-profit organizations (other than small businesses), and small businesses. In addition, the FOA highlights 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, regional organizations, eligible federal agencies, and U.S. territories or possessions, signaling an interest in diverse institutional partners and potentially broader geographic and demographic reach.

Foreign eligibility is restricted in a way that is common for NIH network leadership awards. Non-domestic (non-U.S.) entities and non-domestic components of U.S. organizations are not eligible to apply as the primary applicant organization. However, foreign components are allowed as defined in the NIH Grants Policy Statement, meaning a U.S.-based applicant may include certain collaborations or activities involving foreign institutions or sites if they meet NIH requirements and are justified within the proposed work. This structure keeps the leadership and primary award administration within the U.S. while still permitting international scientific collaboration when it adds value.

Administratively, the funding is categorized under health (CFDA 93.855) and was posted with an original application due date of June 9, 2023, with a creation date of February 7, 2023. The source information provided does not list an award ceiling, expected number of awards, or other budgetary specifics, so applicants would typically need to consult the full FOA text for funding level, project period, and detailed requirements. In sum, this opportunity is designed to fund the central leadership entity that will set CoFARs scientific agenda, coordinate and oversee network-wide clinical trials and studies across multiple food allergy related diseases, and partner closely with CoFAR clinical sites to deliver high-quality, impactful research intended to improve prevention and patient care.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Consortium for Food Allergy Research: Leadership Center (UM1 Clinical Trial Required)" 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 2023-02-07.
• Applicants must submit their applications by 2023-06-09. (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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