Internal Deadline: Contact RII.
LOI: 30 days prior.
External Deadline: June 9, 2023
Award Type: Cooperative Agreement
Estimated Number of Awards: NIAID intends to commit a total of $12.1 million in FY 2024 to support all the activities of the Consortium for Food Allergy Research Program. This $12.1 million includes funding for: 1) 12 awards for CoFAR CRCs at an estimated $400,000 per award, and 2) through the companion FOA, the support for one award for the CoFAR Leadership Center.
Anticipated Award Amount: Costs should be appropriate to the needs of the proposed project(s). This includes funding for: 1) personnel time to partially support CoFAR network-wide clinical research projects, 2) personnel time and other costs for the proposed CRC-specific research project(s).
Who May Serve as PI: Standard NIH requirements.
Link to Award: https://grants.nih.gov/grants/guide/rfa-files/RFA-AI-22-076.html
Process for Limited Submissions
PIs must submit their application as a Limited Submission through the Research Initiatives and Infrastructure (RII) Application Portal: https://rii.usc.edu/oor-portal/. Use the template provided here:
Materials to submit include:
- (1) Two-Page Proposal Summary (0.5” margins; single-spaced; font type: Arial, Helvetica, or Georgia typeface; font size: 11 pt). Page limit includes references and illustrations. Pages that exceed the 2-page limit will be excluded from review. You must use the template linked above.
- (2) CV – (5 pages maximum)
Note: The portal requires information about the PIs in addition to department and contact information, including the 10-digit USC ID#, Gender, and Ethnicity. Please have this material prepared before beginning this application.
CoFAR is a clinical network consisting of two distinct entities, the CoFAR Leadership Center (LC) and the CoFAR Clinical Research Centers (CRCs). The two entities will work collaboratively to conduct network-wide, ground-breaking clinical research projects in the areas of prevention, therapy, and understanding of the mechanisms of food allergy. The CoFAR-LC will provide leadership, overall strategy, and support for the network-wide clinical research projects. The CoFAR-CRCs will execute all network-wide clinical research projects.
It is expected that CoFAR will conduct at least two network-wide clinical research projects. At least one of these projects will be a therapeutic or preventive clinical trial. Both the CoFAR-LC and the CoFAR-CRCs will propose network-wide clinical research projects. Once CoFAR is formed, these proposals will be considered by the CoFAR Steering Committee and those to be executed will be chosen by the CoFAR-LC PD(s)/PI(s). The network-wide clinical research projects that the CoFAR will conduct will require approval by NIAID, which will consider programmatic priorities in its decision.
Each CoFAR-CRC will propose one network-wide clinical trial or observational study. In addition, each CoFAR-CRC will conduct one or two center-specific research projects.
The scope of the network-wide, multi-center clinical trial or observational study the CoFAR-CRC will propose includes but is not limited to:
- Therapeutic or preventive trials of
- Early allergenic food introduction for the prevention of IgE-mediated food allergy
- Direct or indirect manipulation of the microbiome
- Food allergen immunotherapy
- Drugs, biologics, adjuvants, or devices for the management of food allergy conditions
- Combinations of the above
- Studies to improve the diagnosis of food allergy aiming at replacing oral food challenges
- Studies to accurately assess the incidence and prevalence of food allergy conditions in diverse populations, in the US
- Studies examining the interactions between immunologic, microbial, environmental, and genetic or epigenetic factors underlying the development of food allergy conditions
- Studies of molecular mechanisms associated with the development and clinical presentation of food allergy conditions or response to therapy (targeted and/or unbiased approaches)
- Studies on the mechanisms underlying severe allergic reactions
The center-specific research projects the CoFAR-CRCs will conduct can be a non-therapeutic observational study, a clinical mechanistic study, or a laboratory study utilizing new or existing human biosamples. The center-specific project should involve junior faculty investigators in key roles whenever possible. Clinical trials per the NIH definition (https://grants.nih.gov/policy/clinical-trials/definition.htm) are not allowed to be proposed for center-specific research projects. One of the goals of the center-specific research projects is to provide pilot data to inform potential larger, future CoFAR network-wide projects and to assess various aspects of the presentation of food allergy in diverse populations.
The scope of center-specific research projects includes, but is not limited to:
- Small scale investigations of mechanisms related to response to oral food challenges
- Development of biomarkers for the diagnosis of a particular food allergy condition or for predicting severity of food reactions
- Analysis of samples obtained prospectively from protocols funded by other sources or clinical samples obtained under IRB approval
- Analysis of existing data sets or samples available to the site
- Electronic Health Record research on food allergy conditions
- Development of a new laboratory methodology with direct clinical implications
- Qualitative assessments to investigate practices/ perceptions/ behaviors as they pertain to various food allergy conditions
Applicants may submit to both the CoFAR Leadership Center (RFA-AI-22-077) and the CoFAR Clinical Research Centers. However, an applicant must propose different network-wide clinical trials in each of the two applications.
Applications that propose the following topics will be considered non-responsive and will not be reviewed
- Research conducted in animals or animal cells (including humanized mice)
- Center-specific projects involving more than one clinical site
- Center-specific clinical trials
- Research on immunologic or non-immunologic food-related diseases other than IgE-mediated food allergy, FPIES, AGS, or EoE, such as celiac disease, irritable bowel syndrome, or food intolerances
- Research on HIV/AIDS
Note: Foreign Components may only provide services in support of clinical study or clinical trial activities (e.g., conduct of laboratory assays). Foreign Components must not conduct clinical trials or clinical studies.
Visit our Institutionally Limited Submission webpage for more updates and other announcements.