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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FAQs: NIH/NIAID CoFAR Leadership Center (RFA-AI-22-077, UM1)

What is this funding opportunity?

This is a discretionary funding opportunity from the National Institutes of Health (NIH), issued through the National Institute of Allergy and Infectious Diseases (NIAID). The solicitation is RFA-AI-22-077 and it supports a Leadership Center for the Consortium for Food Allergy Research (CoFAR).

What is being funded?

The award funds a single, central Leadership Center that serves as the leadership and coordinating hub for the CoFAR network. The Leadership Center is expected to set consortium-wide scientific direction and coordinate and oversee network-wide clinical research.

What is the main goal of the CoFAR Leadership Center?

The overall goal is to provide central leadership that ensures CoFAR clinical research is designed, prioritized, and managed in a way that accelerates progress in food allergy prevention, diagnosis, and treatment.

What funding mechanism is used?

The opportunity uses a cooperative agreement mechanism (UM1). This typically means NIH/NIAID will have substantial programmatic involvement in the funded activities, consistent with cooperative agreement expectations.

Does this opportunity require a clinical trial component?

Yes. The opportunity explicitly requires a clinical trial component. The funded Leadership Center is expected to be directly involved in planning and oversight of clinical trials as part of its core responsibilities.

What role does NIH/NIAID play during the award?

Because this is a cooperative agreement (UM1), NIH/NIAID is expected to have substantial programmatic involvement. The Leadership Center should anticipate ongoing coordination with NIH/NIAID as part of the cooperative agreement structure.

What kinds of research does the Leadership Center coordinate?

The Leadership Center is expected to define the consortium-wide research strategy and drive the design and oversight of clinical trials and clinical studies across the CoFAR network, with an emphasis on advancing prevention and management strategies and improving understanding of disease origins and pathophysiology.

Which diseases and conditions are included in the scientific scope?

The scope includes several priority conditions: IgE-mediated food allergy, Alpha-Gal Syndrome, Food Protein-Induced Enterocolitis Syndrome (FPIES), and Eosinophilic Esophagitis (EoE).

What is IgE-mediated food allergy in the context of this program?

IgE-mediated food allergy is described as the classic immediate-type allergic reaction to foods and is one of the priority conditions within the consortium scope.

What is Alpha-Gal Syndrome in the context of this program?

Alpha-Gal Syndrome is described as a tick-associated, IgE-mediated allergy to mammalian meat or products containing alpha-gal, and it is explicitly included as a priority condition.

What is FPIES in the context of this program?

Food Protein-Induced Enterocolitis Syndrome (FPIES) is described as a typically non-IgE-mediated food allergy syndrome characterized by delayed gastrointestinal symptoms, and it is included as a priority condition.

What is EoE in the context of this program?

Eosinophilic Esophagitis (EoE) is described as a chronic immune-mediated disease of the esophagus often linked to food triggers, and it is included as a priority condition.

What are the core responsibilities of the Leadership Center?

Based on the information provided, core responsibilities include: setting scientific direction for the network; defining a consortium-wide research strategy; selecting and prioritizing impactful research questions; developing rigorous protocols; standardizing approaches to enable comparison and pooling of results; and planning and overseeing clinical trials and clinical studies conducted across the network.

How does the Leadership Center work with CoFAR Clinical Research Centers (CRCs)?

The Leadership Center is expected to work closely and collaboratively with the CoFAR Clinical Research Centers (CRCs) to select and implement all CoFAR network-wide clinical trials and studies.

What is the division of responsibilities between the Leadership Center and the CRCs?

The Leadership Center leads network planning, harmonization, and oversight. The CRCs carry primary responsibility for executing the trials and studies at the site level, including participant recruitment, conduct of the study at the site, and local implementation.

Why is standardization emphasized for this Leadership Center?

Standardization is highlighted to allow results to be compared and combined across sites, supporting a unified multi-site research program and increasing the value and interpretability of network-wide findings.

Who is eligible to apply?

Eligibility is broad and includes: U.S. 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; nonprofits (501(c)(3) and non-501(c)(3), excluding those that are institutions of higher education in those nonprofit categories); for-profit organizations (other than small businesses); small businesses; eligible federal agencies; and U.S. territories or possessions.

Are minority-serving institutions and community-based organizations included in the eligible categories?

Yes. The opportunity highlights categories such as Alaska Native and Native Hawaiian Serving Institutions, AANAPISIs, Hispanic-serving Institutions, HBCUs, TCCUs, faith-based or community-based organizations, and regional organizations, indicating interest in diverse institutional partners.

Can a non-U.S. (foreign) organization apply as the primary applicant?

No. Non-domestic (non-U.S.) entities are not eligible to apply as the primary applicant organization, and non-domestic components of U.S. organizations are also not eligible to apply as the primary applicant.

Are foreign collaborations allowed at all?

Yes. Foreign components are allowed as defined in the NIH Grants Policy Statement. This means a U.S.-based applicant may include certain foreign collaborations or activities if they meet NIH requirements and are justified within the proposed work.

What is the CFDA number and program area?

The funding is categorized under health, with CFDA 93.855.

When was this opportunity created and when was the application due?

The creation date listed is February 7, 2023. The original application due date listed is June 9, 2023.

Does the provided information include the award ceiling, budget amount, project period, or expected number of awards?

No. The source information provided does not list an award ceiling, expected number of awards, or other budgetary specifics. Those details would typically be found in the full FOA text.

What is the practical outcome NIAID is trying to achieve with this Leadership Center?

The intent is to create a unified national research program where the Leadership Center ensures consistency, quality, and strategic alignment, while the CRCs provide operational capacity to run complex multi-site clinical research efficiently and safely, ultimately improving prevention and patient care for food allergy-related diseases.

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