Opportunity Information: Apply for RFA AI 22 076
The National Institutes of Health (NIH), through the National Institute of Allergy and Infectious Diseases (NIAID), released this funding opportunity to support Clinical Research Centers (CRCs) that will make up part of the Consortium for Food Allergy Research (CoFAR). The award mechanism is a U01 cooperative agreement, which means awardees are expected to work in a coordinated way with NIH and other consortium partners rather than operating as fully independent grantees. The opportunity is explicitly marked as "Clinical Trial Required," signaling that the funded centers are expected to have the capacity and readiness to run clinical trials as part of their portfolio, along with other forms of human clinical research.
The core purpose of the program is to strengthen and expand a national research network focused on food allergy and related conditions by funding CRC sites that can carry out both consortium-wide and site-specific studies. On the network side, these CRCs will implement shared observational studies and clinical trials designed across the consortium, helping generate comparable, high-quality data across multiple locations. On the local side, each CRC is also expected to conduct its own center-specific human research projects that align with CoFAR goals. Across both types of work, the emphasis is on advancing prevention and management strategies and improving scientific understanding of disease origins and underlying biology (pathophysiology).
The scientific scope is broader than classic IgE-mediated food allergy alone. In addition to IgE-mediated food allergy, the FOA highlights Alpha-Gal Syndrome (a tick-associated allergy to a carbohydrate found in mammalian meat), Food Protein-induced Enterocolitis Syndrome (FPIES, a typically non-IgE-mediated food allergy that affects the gastrointestinal tract and can cause severe reactions), and Eosinophilic Esophagitis (EoE, a chronic immune-mediated condition of the esophagus often linked to food triggers). By bundling these conditions, the program signals an interest in shared mechanisms, better phenotyping, improved diagnostic and monitoring approaches, and more effective interventions that can translate into real-world clinical practice.
Operationally, the CRCs are expected to work closely with the CoFAR Leadership Center (CoFAR-LC) for consortium-wide clinical research projects and other network functions. In practice, that kind of structure usually involves common protocols, shared data and safety oversight expectations, harmonized recruitment and retention practices, centralized coordination for multi-site studies, and cross-site collaboration on analysis and dissemination. The CRC role is therefore not just to run studies locally, but also to function as a reliable node in a larger, coordinated clinical research enterprise.
Eligibility is broad and includes many U.S.-based organization types commonly allowed under NIH funding, such as public and private institutions of higher education, nonprofit organizations (with or without 501(c)(3) status), for-profit organizations (other than small businesses), small businesses, and multiple levels of government (state, county, city/township, special districts), as well as independent school districts and public housing authorities/Indian housing authorities. Federally recognized Native American tribal governments are eligible, as are Native American tribal organizations that are not federally recognized governments. The FOA also calls out additional eligible applicant categories, including 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. However, the opportunity draws a clear boundary around foreign participation: non-U.S. entities (foreign organizations and foreign institutions) are not eligible to apply, and non-domestic components of U.S. organizations are not eligible to apply. At the same time, "foreign components" are allowed as defined by the NIH Grants Policy Statement, meaning a U.S. applicant may include certain types of international involvement when justified and compliant with NIH policy, even though the applicant organization itself must be U.S.-based.
Administratively, the funding opportunity number is RFA-AI-22-076, and it falls under the Health activity category with CFDA number 93.855. The funding instrument is a cooperative agreement, reinforcing the expectation of substantial NIH involvement and active coordination across sites. The original closing date listed is 2023-06-09, and the FOA was created on 2023-02-07. The award ceiling and expected number of awards are not specified in the provided listing, which typically means applicants would need to consult the full FOA text for budgeting constraints, anticipated consortium size, project period details, and any per-site caps or modular budget requirements.
Overall, this opportunity is designed for organizations that can serve as high-performing clinical research hubs: capable of recruiting and evaluating participants, conducting rigorous observational studies and interventional trials, meeting regulatory and human subjects protection requirements, and collaborating efficiently across a coordinated network. The long-term aim is to accelerate clinically meaningful progress in how food allergy and related immune-mediated conditions are prevented, understood, and managed, using a structured consortium model that emphasizes consistency, scale, and shared scientific direction.Apply for RFA AI 22 076
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Consortium for Food Allergy Research: Clinical Research Center (U01 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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Frequently Asked Questions (FAQs) - NIH/NIAID CoFAR Clinical Research Centers (RFA-AI-22-076)
What is this funding opportunity?
This is a National Institutes of Health (NIH) funding opportunity issued through the National Institute of Allergy and Infectious Diseases (NIAID) to support Clinical Research Centers (CRCs) that will be part of the Consortium for Food Allergy Research (CoFAR).
What is the FOA number and basic identifier information?
The funding opportunity announcement (FOA) number is RFA-AI-22-076. The activity category is Health, and the CFDA number listed is 93.855.
What is the award mechanism?
The award mechanism is a U01 cooperative agreement. This indicates substantial NIH involvement and an expectation that awardees will coordinate closely with NIH and consortium partners.
What does a U01 cooperative agreement imply for how the work is conducted?
A U01 cooperative agreement generally means the funded centers are expected to operate as part of a coordinated consortium rather than as fully independent grantees. The CRCs should be prepared for active collaboration with NIH and other CoFAR components and to participate in shared consortium processes.
Is a clinical trial required under this opportunity?
Yes. The opportunity is explicitly marked as "Clinical Trial Required", which signals that funded CRCs are expected to have the capacity and readiness to run clinical trials as part of their research portfolio, alongside other forms of human clinical research.
What is the core purpose of funding Clinical Research Centers (CRCs) under CoFAR?
The purpose is to strengthen and expand a national research network focused on food allergy and related conditions by funding CRC sites that can conduct both consortium-wide and site-specific human clinical research. The overall emphasis is on prevention and management strategies and improving scientific understanding of disease origins and underlying biology (pathophysiology).
What kinds of research are CRCs expected to conduct?
CRCs are expected to conduct:
- Consortium-wide observational studies and clinical trials using shared designs and approaches across multiple locations.
- Center-specific human research projects developed and conducted by the CRC that align with CoFAR goals.
What is meant by consortium-wide studies?
Consortium-wide studies are shared observational studies and clinical trials designed across the CoFAR network. CRCs implement these studies at their sites to help generate comparable, high-quality data across multiple locations.
Are sites also expected to run their own local projects?
Yes. In addition to participating in consortium-wide projects, each CRC is expected to conduct its own center-specific human research projects that align with CoFAR goals.
Which conditions are included in the scientific scope?
The scientific scope extends beyond classic IgE-mediated food allergy. The FOA highlights:
- IgE-mediated food allergy
- Alpha-Gal Syndrome (tick-associated allergy to a carbohydrate found in mammalian meat)
- Food Protein-induced Enterocolitis Syndrome (FPIES) (typically non-IgE-mediated, gastrointestinal involvement, can cause severe reactions)
- Eosinophilic Esophagitis (EoE) (chronic immune-mediated condition of the esophagus often linked to food triggers)
Why does the FOA include conditions beyond IgE-mediated food allergy?
By bundling these conditions, the program signals interest in shared mechanisms, better phenotyping, improved diagnostic and monitoring approaches, and interventions that can translate into real-world clinical practice.
What types of outcomes or advances is the program aiming to accelerate?
The program aims to accelerate clinically meaningful progress in how food allergy and related immune-mediated conditions are prevented, understood, and managed, using a structured consortium model that emphasizes consistency, scale, and shared scientific direction.
How will CRCs coordinate with the rest of the consortium?
CRCs are expected to work closely with the CoFAR Leadership Center (CoFAR-LC) for consortium-wide clinical research projects and other network functions.
What kinds of consortium operations should CRCs be prepared for?
The described consortium structure typically involves common protocols, shared data and safety oversight expectations, harmonized recruitment and retention practices, centralized coordination for multi-site studies, and cross-site collaboration on analysis and dissemination.
Is the CRC role limited to running studies locally?
No. The CRC role includes running studies locally and also functioning as a reliable node in a coordinated clinical research enterprise, contributing to network-wide implementation and collaboration.
Who is eligible to apply?
Eligibility is broad and includes many U.S.-based organization types commonly allowed under NIH funding, including:
- Public and private institutions of higher education
- Nonprofit organizations (with or without 501(c)(3) status)
- For-profit organizations (other than small businesses)
- Small businesses
- State, county, city/township, and special district governments
- Independent school districts
- Public housing authorities/Indian housing authorities
- Federally recognized Native American tribal governments
- Native American tribal organizations that are not federally recognized governments
Are there additional categories of organizations explicitly called out as eligible?
Yes. The FOA also calls out eligibility for categories including:
- 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
- U.S. territories or possessions
Are non-U.S. (foreign) organizations eligible to apply?
No. Non-U.S. entities (foreign organizations and foreign institutions) are not eligible to apply.
Can a U.S. organization apply if it proposes a non-domestic component?
No. The opportunity states that non-domestic components of U.S. organizations are not eligible to apply.
Are any types of international involvement allowed at all?
Yes. Although the applicant organization must be U.S.-based and non-U.S. entities cannot apply, the FOA indicates that "foreign components" are allowed as defined by the NIH Grants Policy Statement, when justified and compliant with NIH policy.
What types of capabilities are implied for a high-performing CRC under this program?
The opportunity is designed for organizations that can serve as clinical research hubs capable of recruiting and evaluating participants, conducting rigorous observational studies and interventional trials, meeting regulatory and human subjects protection requirements, and collaborating efficiently across a coordinated network.
What is the application closing date listed in the opportunity summary?
The original closing date listed is 2023-06-09.
When was the FOA created?
The FOA was created on 2023-02-07.
Is the award ceiling provided in the listing?
No. The award ceiling is not specified in the provided listing.
Is the expected number of awards provided in the listing?
No. The expected number of awards is not specified in the provided listing.
Where would applicants typically look for budget limits, consortium size, and project period details?
Because the award ceiling, expected number of awards, and other constraints are not included in the provided listing, applicants would typically need to consult the full FOA text for budgeting constraints, anticipated consortium size, project period details, and any per-site caps or modular budget requirements.
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