Opportunity Information: Apply for RFA AI 15 051

  • The HHS-NIH11 in the health sector is offering a public funding opportunity titled "Consortium for Food Allergy Research: Clinical Research Units (UM1)" and is now available to receive applicants.
  • Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.855, 93.856.
  • This funding opportunity was created on Feb 03, 2016 and posted on Feb 03, 2016.
  • Applicants must submit their applications by Jun 30, 2016. (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 (see text field entitled Additional Information on Eligibility for clarification).
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Opportunity Summary:

This funding opportunity, titled "Consortium for Food Allergy Research: Clinical Research Units (UM1)" (RFA-AI-15-051), is a discretionary NIH cooperative agreement released by the U.S. Department of Health and Human Services, National Institutes of Health (HHS-NIH; specifically NIAID). It supports the Consortium for Food Allergy Research (CoFAR) by funding Clinical Research Units (CRUs) that will serve as the operational backbone for conducting the Consortium's clinical work. The FOA was posted on February 3, 2016, and had a closing date of June 30, 2016. It is associated with CFDA program numbers 93.855 and 93.856 under the broad activity category of Health.

The core purpose of the award is to establish and support CRUs that can implement CoFAR clinical trials and clinical studies. In practical terms, applicants are expected to have the infrastructure, personnel, and clinical research experience needed to run complex human-subjects research, including multi-site studies, under a coordinated Consortium structure. Beyond simply executing protocols developed elsewhere, the CRUs are also expected to help drive the science by proposing innovative, multi-center clinical trials focused on the prevention and treatment of food allergy. That emphasis signals an expectation for forward-looking trial concepts that can move the field, rather than routine or incremental clinical projects.

A defining feature of this opportunity is that it uses a cooperative agreement mechanism (UM1), which typically means NIH program staff will have substantial involvement in the funded activities compared with a standard research project grant. Under this model, the CRUs are not operating independently; they are meant to function as active partners in a larger coordinated network. To meet Consortium objectives, each CRU will work closely with the CoFAR Leadership Center, which is described as providing the scientific strategy and the organizational structure for CoFAR. In other words, the Leadership Center sets overarching direction and coordination, while the CRUs provide the on-the-ground clinical research capacity to enroll participants, execute trial procedures, collect and manage clinical data, and deliver studies consistently across multiple sites.

Eligibility is broad and includes many types of organizations that can credibly support clinical research. Eligible applicants listed include 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 and other tribal organizations; public housing authorities/Indian housing authorities; nonprofit organizations with or without 501(c)(3) status (excluding institutions of higher education in those nonprofit categories as stated); for-profit organizations other than small businesses; small businesses; and other entities as allowed under the FOA's additional eligibility guidance. This wide eligibility suggests the program is focused more on demonstrated capability to conduct high-quality clinical trials than on institutional type.

The opportunity does not specify an award ceiling or expected number of awards in the provided summary fields, so applicants would typically need to consult the full FOA text for budget expectations, project period, scope requirements, and details such as required clinical capabilities, data coordinating expectations, performance milestones, and collaboration requirements across the Consortium. Overall, the FOA is aimed at building a network of clinical sites that can collaboratively design and carry out multi-center trials that advance prevention and therapeutic strategies for food allergy, tightly integrated with a central Leadership Center that orchestrates scientific priorities and Consortium operations.

Frequently Asked Questions (FAQs)

What is the title and funding opportunity number for this grant?

The funding opportunity is titled "Consortium for Food Allergy Research: Clinical Research Units (UM1)" and the FOA number is RFA-AI-15-051.

Which federal agency is offering this funding opportunity?

This is a discretionary NIH cooperative agreement released by the U.S. Department of Health and Human Services (HHS), National Institutes of Health (NIH), specifically the National Institute of Allergy and Infectious Diseases (NIAID).

What program or consortium does this opportunity support?

The award supports the Consortium for Food Allergy Research (CoFAR) by funding Clinical Research Units (CRUs) that serve as the operational backbone for CoFAR clinical work.

What is being funded under this opportunity?

This opportunity funds Clinical Research Units (CRUs) to establish and support the clinical infrastructure needed to implement CoFAR clinical trials and clinical studies, including multi-site studies conducted under a coordinated Consortium structure.

What is the main purpose of the Clinical Research Units (CRUs)?

The CRUs are intended to provide on-the-ground clinical research capacity to enroll participants, execute trial procedures, collect and manage clinical data, and deliver studies consistently across multiple sites in alignment with Consortium objectives.

Are CRUs only responsible for executing protocols, or can they help shape the research?

Beyond executing protocols, CRUs are also expected to help drive the science by proposing innovative, multi-center clinical trials focused on the prevention and treatment of food allergy. The emphasis is on forward-looking trial concepts rather than routine or incremental clinical projects.

What funding mechanism is used for this award?

The opportunity uses a cooperative agreement mechanism (UM1).

What does the UM1 cooperative agreement structure imply for how the project will be run?

Because this is a cooperative agreement, NIH program staff typically have substantial involvement in the funded activities compared with a standard research project grant. Under this model, CRUs are not intended to operate independently; they function as active partners in a larger coordinated network.

How do funded CRUs interact with the CoFAR Leadership Center?

Each CRU is expected to work closely with the CoFAR Leadership Center. The Leadership Center provides scientific strategy and organizational structure for CoFAR, setting overarching direction and coordination, while CRUs deliver the operational clinical research capacity across sites.

What kinds of studies are CRUs expected to support?

CRUs are expected to support complex human-subjects clinical research, including multi-center clinical trials and clinical studies addressing prevention and treatment approaches for food allergy within the CoFAR network.

When was the FOA posted, and when did it close?

The FOA was posted on February 3, 2016, and had a closing date of June 30, 2016.

What is the broad activity category for this opportunity?

The opportunity is listed under the broad activity category of Health.

What CFDA program numbers are associated with this FOA?

This FOA is associated with CFDA program numbers 93.855 and 93.856.

Who is eligible to apply?

Eligibility is broad and includes: 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 and other tribal organizations; public housing authorities/Indian housing authorities; nonprofit organizations with or without 501(c)(3) status (excluding institutions of higher education in those nonprofit categories as stated); for-profit organizations other than small businesses; small businesses; and other entities as allowed under the FOA's additional eligibility guidance.

Does the opportunity favor a specific type of institution?

Based on the provided summary, eligibility spans many organization types, suggesting the focus is on demonstrated capability to conduct high-quality clinical trials and coordinated multi-site human-subjects research rather than institutional type.

Does the provided summary specify an award ceiling or the expected number of awards?

No. The provided summary fields do not specify an award ceiling or the expected number of awards.

Where would applicants normally look for budget expectations and project period details?

Because the provided summary does not include an award ceiling, number of awards, budget expectations, or project period, applicants would typically need to consult the full FOA text for those details, as well as scope requirements and other operational expectations.

What types of capabilities are applicants expected to have?

Applicants are expected to have the infrastructure, personnel, and clinical research experience needed to run complex human-subjects research, including multi-site studies, under a coordinated Consortium structure.

What is the overall goal of this FOA?

The overall goal is to build a network of clinical sites that can collaboratively design and carry out multi-center trials that advance prevention and therapeutic strategies for food allergy, tightly integrated with a central Leadership Center that orchestrates scientific priorities and Consortium operations.

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