March 21, 2022
PAR-21-293 Clinical and Translational Science Award (UM1 Clinical Trial Optional)
NOT-TR-22-025 Notice of Change in Award Information to PAR-21-293 Clinical and Translational Science Award (UM1 Clinical Trial Optional)
National Center for Advancing Translational Sciences (NCATS)
The purpose of this Notice is to inform potential applicants of changes in the Funding Opportunity Description and Application and Submission Information in PAR-21-293 Clinical and Translational Science Award (UM1 Clinical Trial Optional). These changes are in response to Congressional report language in the Joint Explanatory Statement for the Consolidated Appropriations Act, 2022.
Part 2. Full Text of Announcement
Section I. Funding Opportunity Description
Currently Reads:
CTSA Program
The CTSA Program is one component of the NCATS Strategic Plan to advance CTS; it is designed to develop and implement innovative solutions that will improve the efficiency, quality, and impact of the process for turning observations in the laboratory, clinic, and community into interventions that improve the health of individuals and communities. The expertise, resources, and infrastructure of the CTSA Program facilitate innovation and provide support for all scientific/medical communities engaged in CTS research, including disease and condition-specific research supported by NIH Institutes and Centers. As one of the largest NIH clinical and translational science programs and an exemplar of team science, NCATS envisions the CTSA Program progressing toward a standards-based, interoperable network in a cloud environment where informatics assets, e.g., data, software, and algorithms, can be co-developed and shared across the CTSA consortium in a common GitHub repository.
NCATS recently solicited feedback on the CTSA Program goals, structure, and operations, as well as the FOA, peer review, and grants management of CTSA Program awards. Approaches for feedback included a 2019 public Request for Information (NOT-TR-19-027) and general feedback from CTSA application peer reviewers (see video for an overview presentation of feedback received). Feedback about application structure and submission was incorporated into this and related FOAs, including simplification; delinking of the K and T components from the U component in the U54 application; increased flexibility in determining levels of effort and corresponding budgets within the application; the opportunity for hubs to specialize via a Research Program; separate funding opportunities for companion institutional training, career development, and research education programs; and specialized innovation programs and CTS research resource centers. In addition, in recognition of the importance of clinical research accomplishments and capabilities to accomplish the goals of the CTSA Program, an emphasis on the NIH clinical research funding of all partnering institutions has been included for determination of maximum direct cost budget requests.
Revised to read:
CTSA Program
The CTSA Program is one component of the NCATS Strategic Plan to advance CTS; it is designed to develop and implement innovative solutions that will improve the efficiency, quality, and impact of the process for turning observations in the laboratory, clinic, and community into interventions that improve the health of individuals and communities. The expertise, resources, and infrastructure of the CTSA Program facilitate innovation and provide support for all scientific/medical communities engaged in CTS research, including disease and condition-specific research supported by NIH Institutes and Centers. As one of the largest NIH clinical and translational science programs and an exemplar of team science, NCATS envisions the CTSA Program progressing toward a standards-based, interoperable network in a cloud environment where informatics assets, e.g., data, software, and algorithms, can be co-developed and shared across the CTSA consortium in a common GitHub repository.
NCATS recently solicited feedback on the CTSA Program goals, structure, and operations, as well as the FOA, peer review, and grants management of CTSA Program awards. Approaches for feedback included a 2019 public Request for Information (NOT-TR-19-027) and general feedback from CTSA application peer reviewers (see video for an overview presentation of feedback received). Feedback about application structure and submission was incorporated into this and related FOAs, including simplification; delinking of the K and T components from the U component in the U54 application; increased flexibility in determining levels of effort and corresponding budgets within the application; the opportunity for hubs to specialize via a Research Program; separate funding opportunities for companion institutional training, career development, and research education programs; and specialized innovation programs and CTS research resource centers.
Section IV. Application and Submission Information
2. Content and Form of Application Submission
R&R Budget
Award Budget
Determination of Allowable Budget Request Amount
Currently Reads:
CTSA UM1 hub applications submitted in response to this FOA must be submitted by a single applicant institution, plus the option of one or more partnering institutions and one or more collaborating institutions. Partner/Partnering Institution(s) must be effectively integrated into the proposed activities of the CTSA UM1 hub and are necessary for attaining its strategic goals and research priorities. A Partnering Institution may be included as a partner in only one CTSA UM1 hub application. Collaborator/Collaborating Institution(s) have a significant role in one or more aspects of the CTSA UM1 hub and may be included in more than one CTSA UM1 hub application. NIH funding to the collaborating institution may not be included for determination of maximum direct cost budget requests.
The maximum direct cost amount (DC) that may be requested for the UM1 budget is based on the sum of two NIH funding components: A) 5-year average of the most current DC NIH funding of the applicant institution, plus B) 5-year average total cost (TC) NIH funding in the Clinical Research category of any partner(s).
NIH aggregate fiscal year funding tables with the most current 5-year average of FY costs and the four maximum DC award tiers for CTSA UM1 hubs will be provided on an annual basis. All required information about levels of NIH funding is available at NIH RePORTER; however, for their convenience, applicants are encouraged to use Table A [Institutional NIH direct cost (DC) funding] and Table B [Institutional NIH total cost (TC) funding in the Clinical Research category] provided by NCATS to generate a combined funding amount that defines their maximum DC amount allowable for the annual award. For our CTSAs, NCATS has tiered thresholds that range from $2,600,000 to $6,500,000. To obtain details, applicants are also encouraged to review Table C to identify the four maximum DC award tiers for CTSA UM1 hubs. Requested DC budgets may not exceed the appropriate maximum DC award tier and the amount requested should be well justified and depend on the work proposed. All tables provided by NCATS will be updated on an annual basis and can be found here: https://ncats.nih.gov/ctsa/funding/CPUBRT.
Partners that are Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, or Asian American Native American Pacific Islander Serving Institutions (AANAPISIs) may use either the A) institutional NIH direct cost (DC) funding; or B) institutional NIH total cost (TC) funding in the Clinical Research category, whichever is higher.
In the first paragraph of the budget justification, applicants must summarize how the maximum DC amount requested was determined by providing: A) the name of the applicant institution; B) the name of partnering institution(s) included for funding tier determination, if any; C) the DC NIH funding total amount for the applicant institution from the appropriate NIH DC Funding table; D) the TC NIH funding total amount in the Clinical Research category for partnering institution(s) from the appropriate NIH TC Clinical Research Funding table; and E) the combined total of the figures specified in C) and D).
A single budget is required; include funds requested, as per notes below. Budget justifications must be broken out by Element and Module. Subaward budgets should follow the same format.
Revised to Read:
CTSA UM1 hub applications submitted in response to this FOA must be submitted by a single applicant institution, plus the option of one or more partnering institutions and one or more collaborating institutions. Partner/Partnering Institution(s) must be effectively integrated into the proposed activities of the CTSA UM1 hub and are necessary for attaining its strategic goals and research priorities. A Partnering Institution may be included as a partner in only one CTSA UM1 hub application. Collaborator/Collaborating Institution(s) have a significant role in one or more aspects of the CTSA UM1 hub and may be included in more than one CTSA UM1 hub application. NIH funding to the collaborating institution may not be included for determination of maximum direct cost budget requests.
The maximum direct cost amount (DC) that may be requested for the UM1 budget is based on the sum of two NIH funding components: A) 5-year average of the most current NIH DC funding of the applicant institution, plus B) 5-year average of the most current NIH DC of any partner(s).
NIH aggregate fiscal year funding tables with the most current 5-year average of FY costs and the four maximum DC award tiers for CTSA UM1 hubs will be provided on an annual basis. All required information about levels of NIH funding is available at NIH RePORTER; however, for their convenience, applicants are encouraged to use Table A [Institutional NIH direct cost (DC) funding] provided by NCATS to generate a combined funding amount that defines their maximum DC amount allowable for the annual award. For our CTSAs, NCATS has tiered thresholds that range from $2,600,000 to $6,500,000. CTSA UL1 award recipients funded previously under PAR-18-940, PAR-18-464, PAR-15-304 or RFA-TR-12-006, may request the appropriate tiered UM1 threshold shown on Table B but will not receive more than a 5% reduction in DC annual support for the core hub responsibilities (UM1) relative to the last budget period of the previous competitive project period of their UL1 award, exclusive of administrative supplements/competitive revisions and subaward F&A. Thus, those CTSA UL1 award recipients whose UM1 DC Tier calculation is more than a 5% reduction in DC annual support may submit a budget request at 95% of the DC level of the last budget period of the previous competitive project period of their UL1 award, exclusive of administrative supplements/competitive revisions and subaward F&A. To obtain details, applicants are also encouraged to review Table B to identify the four maximum DC award tiers for CTSA UM1 hubs. Requested DC budgets may not exceed the appropriate maximum DC award tier and the amount requested should be well justified and depend on the work proposed. All tables provided by NCATS will be updated on an annual basis and can be found here: https://ncats.nih.gov/ctsa/funding/CPUBRT.
In the first paragraph of the budget justification, applicants must summarize how the maximum DC amount requested was determined by providing: a) the name of the applicant institution; b) the name of partnering institution(s) included for funding tier determination, if any; c) the NIH DC funding total amount for the applicant institution from the NIH DC Funding Table A; d) the NIH DC funding total amount for partnering institution(s) from the NIH DC Funding Table A; and e) the combined total of the figures specified in c) and d).
A single budget is required; include funds requested, as per notes below. Budget justifications must be broken out by Element and Module. Subaward budgets should follow the same format.
All other aspects of the Funding Opportunity Announcement remain unchanged.
Erica Rosemond, Ph.D.
National Center for Advancing Translational Sciences (NCATS)
Telephone: 301-594-8927
Email: CTSAFOAQuestions@mail.nih.gov
and Human Services (HHS)
