We have identified five subaward sites that will be part of our consortium and we have determined a set amount of direct costs for each subaward. We have set the indirect cost rates at 65% among the total participating sites. Is this budgeting allowable?

NIH’s specific policy regarding this topic is discussed in the NIH Grants Policy Statement (NIH-GPS). Specifically, Sections 15.2.3 and 7.4 address the matter. Key passages from these sections are as follows:

• NIH-GPS, Section 2.3.7.1 ~ Applications That Include Consortium/Contractual F&A Costs – For NOFOs that include a direct cost limit, NIH policy excludes consortium/contractual F&A when determining if an applicant is in compliance with the direct cost limitation. In the case of this CCIA NOFO, an annual direct cost funding limit of $650,000 has been established for both the UG3 & UH3 phases. See CCIA Award Budget (Direct Costs).
• NIH-GPS Section 15.2.3 ~ Consortium Agreements (Allowable and Unallowable Costs) – Recipients must use an approved federally recognized indirect cost rate negotiated between the subrecipient and the Federal Government.
• NIH-GPS Section 7.4 ~ Costs Consideration (Reimbursements of F&A Costs) – If a subrecipient already has a negotiated indirect cost rate established with their cognizant agency for indirect cost, the negotiated rate must be used.

Organizational Eligibility

We have submitted a renewal application in response to PAR-21-293 for a UM1 CTSA award but the application has not yet been funded. Are we eligible to apply? 

Only active CTSA Hub prime and partnering organizations are eligible to apply. For both UG3 and UH3 Phases, an application must involve at least three currently active eligible organizations as of the due date of the application. If the current UL1 award is in a no cost extension or cost extension, it is not considered as an active eligible organization to count towards the minimum number of eligible organizations as stated in the funding opportunity announcement. If the UM1 application were not funded before the CCIA application due date, the UM1 award would not be considered an active eligible organization. See Eligible Organizations.

I work at “X” Medical Center and we collaborate with two CTSA awardees. There is some confusion whether our medical center is an affiliate or partnering organization with one or both of the CTSAs. How can we confirm our partner status as we move forward with the grant proposal?

The latest list of partners for the CTSA Program hubs can be found on the CCIA web page CTSA Partner List-FY23. You can also contact the program staff at CTSA_COLLABORATIVEINNOVATION@mail.nih.gov.

To meet the eligibility requirements for Notice of Special Interest (NOSI): Collaborative and Innovative Research to Advance Regulatory Science: Partnership of FDA Centers of Excellence in Regulatory Science and Innovation (CERSI) and NIH Clinical and Translational Science Award (CTSA) Programs (NOT-TR-24-006), must two CTSA institutions work with one of the renewed CERSIs (i.e., University of Maryland, UCSF, Hopkins, UNC, or Yale) or is it possible to work with the newly-funded UNC-Duke CERSI?

The UG3/UH3 application must involve at least two different currently active CTSA Program hubs and one or more currently active FDA organizations Centers of Excellence in Regulatory Science and Innovation Program (RFA-FD-23-004 and subsequent reissues). As per the FDA CERSI Program, currently active awardees include the: (1) University of Maryland, (2) Johns Hopkins University, (3) Yale University in joint effort with Mayo Clinic, (4) University of California at San Francisco (UCSF) in a joint effort with Stanford University (UCSF-Stanford), and (5) University of North Carolina, Chapel Hill, in a partnership with Duke University. Only the prime organizations of FDA CERSI Program awards are eligible to count towards the minimum of 3 active eligible organizations. The partnering organization of FDA CERSI Program award recipient can be an additional collaborating site, but it cannot count toward the minimum number of eligible organizations.

The CTSA program hub is in the final year of the award, am I still eligible to apply?

The CTSA Program hub award must be active as of the due date of the application. A hub that is in extension status is not considered a currently active CTSA hub. See Eligible CTSA Program Hub.

In terms of Option 1, can a non-CTSA hub apply as the PRIME if the other three sites are active and funded CTSA hubs at the time of application? Or does the PRIME have to strictly be a CTSA for option 1?

Only active CTSA Hub prime and partnering organizations are eligible to apply as the prime organization.

Individual Eligibility

I am an Investigator at an affiliate of a CTSA Hub. Can I apply as the contact PD/PI?

The contact PD/PI must be an investigator from a prime or partnering organization where there is currently an active CTSA Program hub as of the due date of the application. Investigators from affiliated organizations and who are not from an active CTSA hub can co-direct a project using the multiple PD/PI option in collaboration with a contact PD/PI but may not serve as the contact PD/PI. See Eligible PD/PIs.

I don’t have a doctorate degree but my colleague does is a Core Director at a CTSA. I’m affiliated with the CTSA but don’t have a formal appointment with the Institution. Am I eligible to serve as a co-PI for this project?

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support.

Investigators who are not from CTSA hubs, but who wish to bring an innovative project to the CTSA Program, can co-direct a project using the multiple PD/PI option in collaboration with a contact PD/PI. See Eligible PD/PIs.

If one wants to apply for the Collaborative and Innovative Research to Advance Regulatory Science: Partnership of FDA Centers of Excellence in Regulatory Science and Innovation (CERSI) and NIH Clinical and Translational Science Award (CTSA) Programs NOSI (NOT-TR-24-006), would the contact PI need to be from the CERSI institution?

The contact PI must be from either the CTSA award prime or partnering organization. The PI at the CERSI could serve as either an MPI or co-Investigator as appropriate.

Specific Aims

What is the recommended format for the Specific Aims page? Do we list separate Specific Aims for each phase and clearly label as UG3 and UH3 aims? Or can we list one set of global specific aims under which we describe the UG3 and UH3 phases?

Specific aims must be scientifically appropriate for the distinct phases of the project. Include separate aims, within the designated page limit, for both the UG3 and UH3 Phases, and clearly label them as UG3 specific aims and UH3 specific aims. Briefly state the specific aims of the project indicating how the project will contribute to advancing translational science. Both the UG3 and UH3 Phase must specify at least one specific aim that answers a translational science question.

The NOFO indicates we should briefly state the specific aims of the project indicating how the project will contribute to advancing translational science. What does this mean?

Translational science is the field that generates scientific and operational innovations that overcome longstanding challenges along the translational research pipeline. These include scientific, operational, financial, and administrative innovations that transform the way that research is done, making it faster, more efficient, and more impactful. The applicant must propose a project that contributes to advancing translational science.

Milestones

The NOFO mentions that annual milestones should be provided. It is also suggested that a Gannt-chart might be included. I’m used to Gannt-charts being detailed at the quarterly level. Is this what is expected?

There is no need for quarterly milestones. However, clearly defined and appropriately measurable annual milestones for both the UG3 phase and the UH3 phase should be provided. Annual milestones must be feasible for the proposed timeframe. A timetable (e.g., Gantt Chart) identifying when each of the annual milestones will be met should be provided as part of the Milestone Plan attachment. In addition to annual milestones, a clearly defined and appropriately measurable set of transitional milestones must also be provided in the Milestone plan. Distinct from the annual milestones, transitional milestones should provide the ‘go/no go’ assessment criteria for transitioning from the UG3 phase into the UH3 phase of an award.

The NOFO mentions that milestones should be peer-reviewed. Does this mean that the milestones should be publication based and the outcome should be a peer-reviewed manuscript? Or is peer-review more along the lines of NIH approval?

The peer-reviewed milestones referenced in the PAR-22-167 means both the annual and UG3/UH3 transition milestones described in the application will be reviewed by the NCATS special emphasis panel for the scientific merit of the application.

Feasibility

For the feasibility assessment, I am used to addressing feasibility in terms of a clinical trial and enrolling subjects. What is meant by feasibility when not planning a trial? Does the NIH have any guidance as to what a feasibility assessment should contain/look like, or are you able to provide some insights/guidance?

Studies planned for the UG3 should determine whether the innovative intervention to be developed is feasible before disseminating and implementing it in the UH3 phase. Assessments should be scientifically appropriate for the intervention to be tested.

Letters of Support

The instructions state that letters of support from the PD/PI of the CTSA Program hub, contact PD/PI of the participating NIH ICO programs, and the external stakeholder’s organization they are associated with should be included. What is meant by participating in NIH ICO programs?

The contact PD/PI of the participating NIH ICO programs refers to these eligible organizations stated in the FOA. Only the listed NIH programs of participating ICOs are eligible as qualifying organizations under Option 2 for this FOA.

FDA Eligible Grants are funded under the following Funding Opportunity Announcement:

• Centers of Excellence in Regulatory Science and Innovation (RFA-FD-23-004 and subsequent reissues)

NCATS Rare Diseases Clinical Research Consortia Eligible Grants are funded under the following Funding Opportunity Announcements:

• Rare Diseases Clinical Research Network (RFA-TR-18-020; RFA-TR-18-021 and subsequent reissues)

NIAMS Eligible Grants are funded under the following Funding Opportunity Announcements:

• Core Centers for Clinical Research (RFA-AR-22-002; RFA-AR-17-002 and subsequent reissues)
• Centers of Research Translation (RFA-AR-22-001; RFA-AR-17-001; RFA-AR-16-001 and subsequent reissues)

NIGMS Eligible Grants are funded under the following Funding Opportunity Announcements:

• IDeA-Clinical and Translational Research Networks (PAR-14-303, PAR-17-304, PAR-18-265, PAR-20-175 and subsequent reissues)

NIMHD Eligible Grants are funded under the following Funding Opportunity Announcements:

• Research Centers in Minority Institutions Program (RFA-MD-17-003, RFA-MD-17-006, RFA-MD-18-012, RFA-MD-20-006, RFA-MD-22-002 and subsequent reissues)
• Centers for Multiple Chronic Disease Associated with Health Disparities (RFA-MD-21-007 and subsequent reissues)

We are applying for the UG3/UH3 grant mechanism for the first time. Could you please provide clarification on the specified length for the Research Plan section? According to the NIH website, the page limit is stated as 12 pages. However, considering that this application encompasses both UG3 and UH3 phases, is the actual limit 24 pages?

The total page limit for UG3/UH3 is 12 pages. Please see https://grants.nih.gov/grants/how-to-apply-application-guide/format-and-write/page-limits.htm#other.

Human Subjects

We will be assessing recruitment methodologies across our study sites which include human subjects. Would we need to include the Human Subject Study record for this proposal?

Please see the instructions stated in the G.500 – PHS Human Subjects and Clinical Trials Information.

Can CCIA funding be used to support a Phase III Clinical Trial?

Funds may not directly support any clinical trial beyond Phase IIB, except for Phase III clinical trials for treatment of rare diseases. Projects that do not meet these clinical trial limitations will not be reviewed. See NOT-TR-18-025. See also NIH’s Definition of a Phase III Clinical Trial.

Eligibility Statement

Is it enough to describe my eligibility as contact PI, or should I also include the eligibility of other MPI's and/or sub-contract site PI's? There are multiple key personnel that meet the eligibility requirements at multiple institutions. Who should be the one signing this statement?

The intent of the eligibility statement is to have at least one PD/PI in the study team who has expertise in translational science as defined in PAR-22-167. Only one eligibility statement is needed in the application.

Applications must include an Eligibility Statement signed by the CTSA affiliated program contact PD/PI that provides a description of the translational science expertise and period of affiliation on the applicable CTSA program.

Does the eligibility statement document get uploaded with all the letters of support or is it uploaded separately? Could you clarify if the statement should be the 1st page document or at the end of the letters of support?

There is no requirement. It is preferred that the Eligibility Statement be included in “Other Attachments” in the SF424 (R&R), but it can also be uploaded with all letters of support. If the Eligibility Statement is included with the letters of support, it is recommended that it be included as the first page.

Can we include a video link in our application (summary, aims, or research strategy)?

Please see the NIH Guidance for Videos Submitted as NIH Application Materials (NOT-OD-24-067).