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RFA-OD-20-013 - Emergency Awards: RADx-UP Coordination and Data Collection Center (CDCC) (U24 Clinical Trial Optional)

Issued by

Office of The Director, National Institutes of Health (OD)

Purpose

The purpose of this notice is to inform potential applicants of corrections to the budget and review of RFA-OD-20-013 Emergency Awards: RADx-UP Coordination and Data Collection Center (CDCC) (U24 Clinical Trial Optional).

The FOA has been modified as follows:

Funds Available and Anticipated Number of Awards

Currently reads: "NIH intends to commit $7.5 Million in FY 2020 to fund one award."

Modified to read: "NIH intends to commit up to $80 Million over four years to fund one award."

Award Budget

Currently reads: "Application budgets are limited to $5 Million in annual direct costs."

Modified to read: "Application budget is limited to $13 million in annual direct costs."

Scientific Research Objectives - COVID-19 Testing Technology

Currently reads: "The budget for the one-year Rapid Pilot Studies program cannot exceed $200,000 in direct costs, for up to $2,000,000 per year (total costs) exclusive of Facilities and Administrative (F&A) costs on sub-awards. Multi-year pilot projects are not encouraged and will require review and approval by the NIH."

Modified to read: "Projects for Rapid Pilot Studies are one-year in length and the budget for each will not exceed $200,000 in direct costs. CDCC applicants should budget for up to $2,000,000 per year (total costs) for the Rapid Pilot Studies program. In addition to these costs, CDCC applicants should budget for costs associated with the administration of the Rapid Pilot Studies, support of the Rapid Pilot Studies award process and for CDCC support of studies that will be funded by the Rapid Pilot Studies. Multi-year pilot projects are not encouraged and will require review and approval by the NIH."

Scientific Research Objectives - Community Engagement

Currently reads: " Create and implement a mini-grant program to support the inclusion of additional community partners and stakeholder groups not included in the original grant (e.g., support community members to attend meetings, tailored campaign to improve COVID-19 testing uptake in specific groups, etc.). The mini-grants may total up to $50,000 (direct costs). The budget cannot exceed $750,000 per year (total costs) exclusive of Facilities and Administrative (F&A) costs on sub-awards. Multi-year pilot projects are not encouraged and will require review and approval by the NIH."

Modified to read: " Create and implement a Community Collaboration Grants program to support the inclusion of additional community partners and stakeholder groups not included in the original grant (e.g., support community members to attend meetings, tailored campaigns to improve COVID-19 testing uptake in specific groups, etc.). Community Collaboration Grants will be awarded through funds fromthe U24 CDCC Centergrant andeach Community Collaboration Grant may total up to $50,000 (direct costs). CDCC applicants should budget up to $750,000 per year (total costs) for the Community Collaboration Grants program. In addition to these costs, CCDC applicants should budget for costs associated with the administration of the Community Collaboration Grants, support of the award process and for CDCC support of projects that will be funded by the Community Collaboration Grants program. All requests for costs must be allowable as outlined in 45 CFR Part 75.403 and implemented within the NIH Grants Policy Statement. Multi-year pilot projects are not encouraged and will require review and approval by the NIH."

PHS 398 Research Plan

Currently reads: "Describe the research goals of the Rapid Pilot Studies and mini-grant programs. Elucidate plans for establishing, implementing, and evaluating these pilot programs, including the types of projects that will be supported and how the CDCC will attract applicants for national competitions to meet the goals of each program. Provide a plan describing processes for solicitation, review, selection, monitoring, and evaluation of each pilot program."

Modified to read: "Describe the research goals of the Rapid Pilot Studies and Community Collaboration Grants programs. Elucidate plans for establishing, implementing, and evaluating these pilot programs, including the types of projects that will be supported and how the CDCC will attract applicants for national competitions to meet the goals of each program. Provide a plan describing processes for solicitation, review, selection, monitoring, and evaluation of each pilot program."

Review and Selection Process

Currently reads: "Applications will be evaluated for scientific and technical merit by (an) appropriate internal NIH review Group(s), using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications will receive a written critique.

Applications may undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.

Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.
• Applications that include plans to rapidly make data available to the research community, when not limited by Tribal data sharing policy."

Modified to read: " Applications will be evaluated for scientific and technical merit by (an) appropriate NIH review Group(s), using the stated review criteria.

Applications may undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and evaluated.

Appeals of initial review will not be accepted for applications submitted in response to this FOA.

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific review.
• Relevance of the proposed project to program priorities.
• Applications that include plans to rapidly make data available to the research community, when not limited by Tribal data sharing policy."

Cooperative Agreement Terms and Conditions of Award

Currently reads:

"- Link the approaches developed from CDCC to other NIMHD supported networks to ensure that information is shared and utilized on the widest basis possible;"

Modified to read:

"- Link the approaches developed from CDCC to other NIH supported networks to ensure that information is shared and utilized on the widest basis possible;"

Inquiries

Please direct all inquiries to:

Dorothy Castille

National Institute on Minority Health and Health Disparity (NIMHD)

301-594-9411, [email protected]