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 complying 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-24-272 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.

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-FY24. You can also contact the program staff at CTSA_COLLABORATIVEINNOVATION@mail.nih.gov.

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 organization if the other three sites are active and funded CTSA hubs at the time of application? Or does the PRIME organization 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. See here for more information.

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.

NCATS encourages multiple PDs/PIs, particularly when each brings a unique perspective and skill set to the project. PDs/PIs who are Early-Stage Investigators (ESIs) or those in the early stages of independent careers must propose multiple PDs/PIs with investigator(s) who have previously competed successfully as PD/PI for substantial NIH independent research funding from NIH.

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.

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-25-296 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?

The UG3 Phase will support the development, adaptation, and/or demonstration of an innovative solution that accelerates the translational research process. A feasibility assessment should be conducted in the UG3 Phase to ensure that an innovative solution can be successfully disseminated and implemented during the UH3 Phase of the award.

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?

Please see Letters of Support. The contact PD/PI of the participating NIH ICO programs refers to these eligible organizations as stated in the NOFO. Only the listed NIH programs of participating ICOs are eligible as qualifying organizations under Option 2 for this NOFO. Non-CTSA eligibility organizations are listed here.

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.

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-25-296. Only one Eligibility Statement is needed in the application.

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?

The Eligibility Statement should be uploaded as an Other Attachment.

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).

We originally applied to the now-expired CCIA NOFO PAR-22-167. Can we resubmit our application in response to the re-issued CCIA NOFO PAR-25-296, or must it be submitted as a new application?

You may submit as a resubmission to the re-issued NOFO PAR-25-296 (see Application Types Allowed).