Modifications Compared to Previous PAR
- There continue to be three due dates per year for which applicants may choose to submit their applications. Application due dates have been adjusted so that applications are due April 15, 2019, August 15, 2019, December 16, 2019, April 15, 2020, August 17, 2020, December 15, 2020, April 15, 2021, and August 15, 2021.
- Budget allocations for certain UL1 components/cores have been changed from discrete dollar amounts to a percentage of the UL1 award direct costs to enhance flexibility of the CTSA Program Hubs’ abilities to address institutional needs.
- The number of KL2 scholars requested per year is no longer capped but should be well justified for any Institutional Career Development Core. (See NOT-TR-19-010.)
- There is no longer a cap on the number of TL1 training slots, but the maximum allowed for each TL1 budget request is determined by the UL1 and KL2 budgets (direct costs). Applicants may choose to describe a transition period of up to three years for currently appointed trainees only to complete the planned training as described in the current award. (See NOT-TR-19-013.)
- CTSA Program Hubs are expected to use central resources (e.g., the CTSA Program Coordinating Center, the Trial Innovation Network, and the CTSA Program National Center for Data to Health) in order to support collaboration, interoperability of IT platforms, and consistent messaging and communication among CTSA Program hubs. The updated FOA clarifies the requirement for a “Hub Liaison Team to Central Resources” within the Network Capacity Core, instead of RIC/TIC liaisons. Applicants are expected to include a Letter of Support from an authorized institutional official stating that the institution is willing to sign or is a current signatory to the CTSA Program SMART IRB Reliance Agreement. (See NOT-TR-19-014.)
Please note: The primary source of all information regarding PAR-18-940 is the FOA itself and any notices linked therein.
- CTSA Program hubs with more than 16 months of support remaining on the day of the submission deadline are not eligible to apply. If a CTSA Program grant has a May 31, 2020, project period end date, the earliest date on which another application can be submitted in response to this funding opportunity announcement (FOA) is January 25, 2019.
- A partner is defined based on the use of its NIH funding for the purpose of determining the maximum total award direct costs for the CTSA U54 application. Partners included in one CTSA U54 application may not be included as partners in another CTSA U54 application for the purposes of determining the maximum award direct costs.
- Cost Share: This FOA does not require cost share. In accordance with Uniform Guidance Section 2 CFR 200.306, any support pledged by the applicant institution on a voluntary basis that is quantified in the proposal budget will be considered Voluntary Committed Cost Share and be a binding requirement upon receipt of award.
- A link to the table that provides information about the total institutional NIH direct cost (DC) funding for the Federal Fiscal year prior to the submission of the application is provided in the online FOA. The hyperlink to this table is updated in the FOA after January when the NIH updates and freezes the data from the previous fiscal year.
Types of Applications
- Renewal: This Funding Opportunity Announcement (PAR-18-940) allows renewal applications (Type 2) from institutions that were funded under previous FOAs (as described in PAR-18-940) or the current FOA.
- New: Applications from institutions that currently do not have a CTSA Program award or that have an award funded under previous CTSA Program hub award FOAs (as described in PAR-18-940) will be considered as new applications (Type 1). The following content is not allowed anywhere in a new A0 application or its associated components (e.g., letters of support, other attachments):
- Introduction page(s) to respond to critiques from a previous review
- Mention of previous overall or criterion scores or percentiles
- Mention of comments made by previous reviewers
- Mention of how the application or project has been modified since its last submission
- Marks in the application to indicate where the application has been modified since its last submission
- Resubmission: Resubmission applications are accepted in response to the review of an earlier application as A1 resubmissions. (See the NIH policy on resubmissions.)
Application Format and Page Limits
- The page limits specified in this FOA are the same for every applicant, regardless of the amount of funds being requested and whether the applicant already has a CTSA Program grant.
- Instructions in the FOA supersede the more general instructions in Form E SF424 (PDF - 5.61MB). Applicants should follow the PAR-18-940 detailed instructions for preparing an application.
- NIH previously announced the requirement for organizations to submit an Interim Research Performance Progress Report (Interim RPPR) while their renewal application is under consideration. If the recipient organization has submitted a renewal application on or before the date by which a Final RPPR would be required for the current competitive segment, then submission of an Interim RPPR via eRA Commons is now required. For details, see NOT-OD-17-037.
Human Subjects (HS) and Vertebrate Animals (VA)
- The Translational Endeavors Clinical and Translational Research Core should provide funding under the Pilot Translational and Clinical Studies function for a program that provides pilot funding to support translational research projects. It is expected that some of these planned pilots will contain human subjects and/or vertebrate animals that will require approval by NIH prior to initiation. As such, the U54 application is recommended to answer “Yes” to the questions “Are human subjects involved?” and “Are vertebrate animals used?” in the R&R Other Project Information tab under the Overall component. All instructions in the SF424 (R&R) Application Guide must be followed.
- For the Administrative and each Clinical and Translational Research Core, applicants need to answer the questions “Are human subjects (HS) involved?” and “Are vertebrate animals (VA) used?” in the R&R Other Project Information tab of ASSIST. All instructions in the SF424 (R&R) Application Guide must be followed.
- For the K and T components, please follow the detailed guidance in the Form E SF424 Training Instructions (PDF - 5.61MB).
Letters of Support
- General letters of support for the CTSA Program application should be submitted with the Overall section in ASSIST. A letter of support that mentions all components by name should be considered a general letter of support and included once, with the Overall section only. Letters of support should be clear expressions of commitment consistent with achieving the goals of the Program. Applicants are encouraged to limit their letters of support to no more than 30.
- Letters of support that specifically mention individual components (KL2 or TL1) or Cores (i.e., Informatics or Community and Collaboration) can be submitted under each of the components mentioned.
- Applicants are expected to include a Letter of Support from an authorized institutional official stating that the institution is willing to sign or is a current signatory to the CTSA Program SMART IRB Reliance Agreement. (See NOT-TR-19-014.)
- Effective Jan. 25, 2018, NIH policy has eliminated most allowable appendix material for applications.
Progress Report for Renewal and Revision Applications submitted via Grants.gov to NIH using the SF424 (R&R)
- Follow the guidance for MULTI - PROJECT INSTRUCTIONS FOR NIH AND OTHER PHS AGENCIES SF424 (R&R) APPLICATION PACKAGES.
- For the UL1: See page M-101 of the instructions: Note that the Progress Report falls within the Research Strategy and is therefore included in the page limits for the Research Strategy.
- For the TL1 and KL2: See page M-142 of the instructions: A “Progress Report” attachment is required only if the type of application is renewal. (The KL2 section in PAR-18-940 instructs applicants to follow the M.420 - PHS 398 Research Training Program Plan Form in the MULTI - PROJECT INSTRUCTIONS.)
- Publications: Progress Report publications are required for renewal applications and must be uploaded as an attachment. The attachment upload can be included in either the U54 Overall Component or within each Other Component, but the same information should not be included in multiple locations. See page M-102.
Bibliography and References Cited
- The “Bibliography and References Cited” is a required attachment and applicants have the option of including the “Bibliography and References Cited” attachment in the Overall, Other Components, or both sections. This is separate from the progress report publication list that is required for renewal applications.
Hyperlinks and URLs (see NIH — How to Apply)
- Hyperlinks and URLs are allowed only when specifically noted in FOA and form field instructions. It is highly unusual for an FOA to allow links.
- Hyperlinks and URLs may not be used to provide information necessary for review of the application.
- Reviewers are not obligated to view linked sites and are cautioned that they should not access any website that could compromise their anonymity, unless the link to the site was specifically requested in application instructions.
Training and Career Development
- The Scholars for whom support is requested should be stated as the number supported per year — for example, “support is requested for five Scholars per year.” Applicants must include the requested number of Scholars for each year of the five-year project period in the application. The number of KL2 scholars requested per year should be well justified, for any Institutional Career Development Core.
- The distribution of pre- and post-doctoral trainee appointments for which support is requested should be stated as the number supported per year (e.g., “support is requested for three pre-doctoral trainees and five post-doctoral trainees per year”). The distribution of pre- and post-doctoral appointments may be altered over the course of the grant period, but only in a cost-neutral manner and with NCATS’ prior approval.
- Required data tables:
- K component data tables. The updated Form E SF424 Training Instructions (PDF - 5.61MB)
- provide a detailed description of the research training tables. The Introduction to the Data Tables linked under the Form E SF424 Training Instructions provides an overview of the tables, their contents, and the templates. Tables 2 and 8C are required for new, renewal, and revision applications.
- T component data tables. The required data tables will differ depending on the type of application (i.e., new versus renewal/resubmission) and whether the program includes pre- or post-doctoral or short-term training or mixed variations of these. The Form E SF424 Training Instructions provide a detailed description of the required data tables.
- There is no limit on the number of mentors who may be listed for the Institutional Career Development Core (KL2) or the Training Core (TL1). Participating faculty members should be listed in Table 2 of the required training data tables.
- Scholar candidate information is required, and applicants should follow the Form E SF424 Training Program Instructions referenced under the Training Program Plan. Substitute the term “Scholars” for all references to “trainees” in the Instructions.
- The TL1 provides stipend, tuition, training related expenses and travel funds to the trainees. No Administrative Costs are allowed under the TL1. However, staff salaries and non-trainee personnel travel costs may be included in the Administrative Core of the UL1 and are not included in the maximum total costs for the UL1 and KL2 components.
- Up to $1,500 per year per trainee may be requested for travel. (See NOT-TR-19-014.)
What if applicants have questions?
Please direct questions via email to CTSAFOAQuestions@mail.nih.gov. Information in response to emailed questions may be added to this page at a later date.