Application Information for PAR-24-272: Clinical and Translational Science Awards (CTSA) Program (UM1 Clinical Trial Optional)

Either approach to providing a detailed budget justification satisfies PAR-24-272 instructions. Any questions on the budget justification applicable to the NOFO requirements will be reviewed and analyzed during preaward negotiation. Applicants should provide enough detail in the budget justification such that any reviewer could reasonably determine whether the application complies with the NOFO budgetary limitations.

Relevant text from PAR-24-272 found in: Section IV. Application and Submission Information → R&R Budget → Determination of Allowable Budget Request Amount

How do applicants verify their funding tier?

Applicants are strongly encouraged to verify their funding tier calculation with NCATS in advance of application submission through the Clinical and Translational Science Award (CTSA) FOA Questions mailbox (CTSANOFOQuestions@mail.nih.gov). Requests to verify the funding tier calculation should be submitted by the institution’s authorized organization representative. Once NCATS verification is received and recorded, the applicant should include a note in the R&R Budget Section of the application that NCATS has reviewed and accepted the funding calculation prior to submission. In some circumstances, the division of organizations as listed in the NIH RePORTER data table may split two organizations that maintain a legally/financially binding relationship outside the CTSA Program necessary for eligibility in the CTSA Hub Program. A CTSA hub must maintain an integrated research and training environment for clinical and translational science. If you believe that your CTSA hub requires two organizations to be considered prime for the baseline eligibility requirements to be met, please complete the following process:

1. Send an official request for dual prime partnership consideration to the CTSA FOA Questions mailbox (CTSANOFOQuestions@mail.nih.gov). The request must be submitted by an authorized organization representative and include a substantial justification for consideration.
2. The justification must specifically detail the type of legal/financial relationship and provide background as to how this relationship exists without federal grant funding involvement.
3. NCATS will review each request as submitted. If dual prime organization is permitted, the applicant must include a copy of the NCATS acceptance in the grant application. Failure to include the NCATS acceptance in the grant application may render the application ineligible for funding consideration. (Note: Regardless of the decision, only one organization can serve as the applicant organization.)

For more information, visit the CTSA Program UM1 Budget Request Tables web page. 

Per Uniform Guidance Section 75.306, “Under federal research proposals, voluntary committed cost sharing is not expected. It cannot be used as a factor during the merit review of applications or proposals but may be considered if it is both in accordance with HHS award agency regulations and specified in the Notice of Award. Criteria for considering voluntary committed cost sharing and other program policy factors that may be used to determine who may receive a federal award must be explicitly described in the notice of funding opportunity.” There has been a rise in voluntary committed cost share proposed in applications submitted in response to the Clinical and Translational Science Award (CTSA) Hub Program. NCATS has an obligation to ensure that voluntary committed cost share is not considered as a factor of merit review because cost share is neither expected nor required for this program. Therefore, NCATS has provided explicit guidance in the notice of funding opportunity as to how voluntary committed cost share will be considered. Applicants considering proposing voluntary committed cost share in a grant application should work directly with their Office of Sponsored Programs and/or Authorized Organization Representative to understand their institutional policies and procedures for voluntary committed cost share prior to submitting their applications.

Clarification: Note the following definitions:

• Direct Funding: Full and/or partial funding allocated directly to the project from the federal funds awarded.
• Voluntary Committed Cost Share: In accordance with Uniform Guidance 2 CFR 200.306, voluntary committed cost share is cost sharing pledged by the grantee institution on a voluntary basis that is quantified in either the proposal budget or narrative and becomes a binding requirement of the award.
• Voluntary Uncommitted Cost Share: Any effort or resource contributed to a sponsored award that was not included in either the proposal budget or narrative or committed to the sponsor prior to award.

Relevant text from PAR-24-272 found in: Section III. Eligibility Information → 2. Cost Sharing

Applicants should describe the institutional environment and available resources in the resources section of the application. Any applicant identifying voluntary committed cost share in the budget sections of the application will be bound to the cost share commitment for the entire approved project period. Personnel effort requested without salary support will be considered voluntary committed cost share, and the applicant institution will be bound to the relevant salary, fringe, and associated facilities and administrative (i.e., indirect) costs for the entire approved project period. Voluntary committed cost share will not be accepted and will not be considered in the review score for the following categories: key personnel (PD/PIs, module and program leaders/co-leaders), the Resource and Services Module, the CTS Pilot Module, or the CTS Research Program Element. Voluntary committed cost share for other items identified after peer review will be considered; however, any alteration in cost share commitments for the specified categories prior to award will deem the application ineligible for award. Future award consideration would require submission of a revised application.

Can applicants request an abbreviated funding period to get the grant award to start on a particular date?

NCATS grants management staff will take into consideration the requested start date, any prior grant cycle project period end dates and award timing when making approved budget period decisions. Refer to the NOFO for application due dates and review and award cycles for earliest start date.

Relevant text from PAR-24-272 found in: Section II. Award Information → Award Project Period.

In accordance with the NIH Grants Policy Statement, NIH generally applies the additive alternative to all recipients unless otherwise specified in the NoA. Regardless of the alternative applied, program income may be used only for allowable costs in accordance with the applicable cost principles and the terms and conditions of the award. The NOFO does not discourage nor require program income to be earned. For more information, see Section 8.3.2 Program Income of the NIH Grants Policy Statement.

Can a collaborator or an affiliate’s budget be used to calculate the maximum direct-cost budget?

No. For the purposes of PAR-24-272, NCATS will ONLY recognize the term “partner,” and NOT “collaborator” or “affiliate” (or any other term), to determine the maximum direct-cost budget requests.

Relevant text from PAR-24-272 found in: Section I. Notice of Funding Opportunity Description → Key Terms, Definitions, and Uses in this NOFO

Relevant text from PAR-24-272 found in: Section IV. Application and Submission Information → R&R Budget → Determination of Allowable Budget Request Amount

Relevant text from PAR-24-272 found in: Section IV. Application and Submission Information → PHS 398 Research Plan → Letters of Support

For more information see: CTSA Program UM1 Budget Request Tables. This page provides a list of institutions that are partners of CTSA Program hubs.

May researchers who recently submitted an application to PAR-21-293 apply to the new opportunity (PAR-24-272)?

You may not submit an application to PAR-24-272 prior to receiving the summary statement for an application under review for PAR-21-293. Please see NOT-OD-18-197: NIH/AHRQ Application Submission/Resubmission Policy. Specifically:

• Any application overlapping other Public Health Service (PHS) applications that are funded, pending initial peer review (e.g., pending summary statement release) or pending appeal of an earlier review, will not be accepted. This includes derivative or multiple applications that propose to develop a single product, process or service that, with nonsubstantive modifications, can be applied to a variety of purposes.
• Please see Addendum B within the notice about Overlapping Applications.

Can a partner be a collaborator with other hubs?

A partner may be a collaborator with another hub, and a collaborator may be a partner with another hub.

Relevant text from PAR-24-272 found in: Section I. Notice of Funding Opportunity Description → Key Terms, Definitions, and Uses in this NOFO

Will current grantees (active grants funded under FOAs PAR-15-304, PAR-18-464 & PAR-18-940) be considered as new or renewal applications?

All applications will be considered as new.

There is no mention of the Common Metrics Initiative in the new NOFO (PAR-24-272). Will this reporting structure carry on in the next grant?

Following the closeout of the CLIC grant in the summer of 2022, the support of the Common Metrics Initiative was sunsetted.

Applicants for the new NOFO (PAR-24-272) are expected to have a strong Continuous Quality Improvement (CQI) program, which is an ongoing cycle of collecting data and using it to make decisions to gradually improve program processes. This is described in the Strategic Management Element/Module of the new UM1 NOFO (PAR-24-272).

Relevant text from PAR-24-272 found in: Section I. Notice of Funding Opportunity Description → Element B: Strategic Management

The “evaluation” framework in the new CTSA NOFO defines evaluation as “Continuous Quality Improvement (CQI).” On federal sites and with professional evaluator understanding of CQI methods implies the use of Lean Methods, Six Sigma, Kaizen Method, Plan-Do-Study-Act, Value Stream Mapping, and other methods of quality improvement. Are these CQI methods to which the new NOFO refers?

To provide hubs with the flexibility to choose the evaluation method, the NOFO does not encourage a certain type of evaluation method. Applicants should provide a clear justification for the use of the evaluation methods selected for their hub program and sufficient details for how it will be implemented and used to improve activities.

Relevant text from PAR-24-272 found in: Section I. Notice of Funding Opportunity Description → Element B: Strategic Management

How should hubs plan to engage in consortium-wide activities?

The current consortium-wide activities are supported through cooperative agreements that have different project end dates that can be found on the table of activities funded under the CTSA Program (under the Consortium Centers column).

Relevant text from PAR-24-272 found in: Section I. Notice of Funding Opportunity Description → Element B: Hub Liaison Team

CTSA hub senior leadership and HLT may be completely separate or may overlap. An individual may have more than one leader role, and co-leaders are allowed.

Relevant text from PAR-24-272 found in: Section I. Notice of Funding Opportunity Description → Element B: Hub Liaison Team

One of the CTSA Program Goals is to promote partnerships and collaborations to facilitate and accelerate translational research projects locally, regionally and nationally. Applicants are provided the flexibility within the UM1 mechanism and a single budget to balance the emphasis within the hub’s activities and are encouraged to leverage their strengths to drive innovation that would have impact on the hub’s stakeholders and communities. This allows the hubs to showcase their unique capabilities that are expected to strengthen the consortium as a whole and advance clinical and translational science. Furthermore, applicants should plan to describe their Hub Liaison Team.

Relevant text from PAR-24-272 found in: Section I. Notice of Funding Opportunity Description → Element B: Hub Liaison Team

Previous FOAs (PAR-18-940, PAR-18-464 and PAR-15-304) specifically described support for identifying opportunities, establishing best practices for including an increased range of the study population, providing consultations, fostering collaborations, and effecting policy changes to enhance opportunities for integrating special populations (e.g., pediatrics, geriatrics, populations affected by health disparities, rare disease populations or other special populations). As part of community and stakeholder engagement, NCATS is specifically committed to accelerating CTS research to address the significant burden of conditions that disproportionately affect rural, minority, and other underserved populations. Promoting health equity throughout CTSA projects, enrolling underserved populations in research projects, and engaging patients as full collaborators will help ensure that research findings are meaningful to their individual communities. Foundational capabilities and activities in the area of community and stakeholder engagement are required to support and enhance the impact of the CTSA hub. These activities may be encompassed under Element C: Training and Outreach — Community and Stakeholder Engagement Research Module.

Team Science activities are supported under Element C: Training and Outreach.

Relevant text from PAR-24-272 found in: Section I. Notice of Funding Opportunity Description → Element C: Training and Outreach → Workforce Development for Clinical Research Staff Professionals Module

Yes. See the following relevant text from the NOFO:

Relevant text from PAR-24-272 found in: Section IV. Application and Submission Information → R&R Budget → Element C: Training and Outreach

For Element D: Clinical and Translational Sciences Resources and Pilots, are pilots only to be used to address emergencies, like a pandemic?

No. See the term “e.g.” in the following relevant text from the NOFO:

Relevant text from PAR-24-272 found in: Section I. Notice of Funding Opportunity Description → Element D: Clinical and Translational Science Resources and Pilots

Can the application include a description of specific individual pilots?

This section should include only information about the establishment and management of the CTS Pilot Module and should not include any proposed pilots.

Relevant text from PAR-24-272 found in: Section I. Notice of Funding Opportunity Description → Element D: Clinical and Translational Science Resources and Pilots → Clinical and Translational Science (CTS) Pilot Module

Relevant text from PAR-24-272 found in: Section IV. Application and Submission Information → PHS 398 Research Plan → Element D: Clinical and Translational Science Resources and Pilots

Can the hub provide services for investigators to help them with other research studies?

Yes.

Relevant text from PAR-24-272 found in: Section I. Notice of Funding Opportunity Description → Element D: Clinical and Translational Science Resources and Pilots → Resources and Services (R&S) Module

What is the difference between a translational science project and a translational research project?

Please see the following references and relevant text from PAR-24-272.

References:

• The Emerging Field of Translational Science
• Publications:
  • Translating Translation (2018) Christopher P. Austin, Nature Review Drug Discovery, Vol. 17
  • Opportunities and Challenges in Translational Science (2021) Christopher P. Austin, Clinical and Translational Science
  • Transforming Translational Science Fact Sheet
  • Biomedical Translation YouTube Video

Relevant text from PAR-24-272 found in: Section I. Notice of Funding Opportunity Description → Key Terms, Definitions, and Uses in this NOFO

Relevant text from PAR-24-272 found in: Section I. Notice of Funding Opportunity Description → Background

For Element D: Clinical and Translational Science Resources and Pilots — Resources and Services (R&S) Module, the NOFO states that there must be a formalized management plan that addresses solicitation, review, prioritization, funding level, tracking and evaluation. Is this directed at the services or suite of services that the hub chooses to provide? Does the application have to include the management and evaluation plan in addition to a justification for why those services were chosen?

Relevant text from PAR-24-272 found in: Section I. Notice of Funding Opportunity Description → Element D: Clinical and Translational Science Resources and Pilots → Resources and Services (R&S) Module  

Relevant text from PAR-24-272 found in: Section IV. Application and Submission Information → PHS 398 Research Plan → Element D: Clinical and Translational Science Resources and Pilots

Relevant text from PAR-24-272 found in: Section V. Application Review Information → Scored Review Criteria → Significance → Specific to this NOFO

Do the NIH GitHub repository and cloud-based resources currently exist?

Yes. Awardees will have access to the NCATS GitHub to share and host repositories for version control and collaboration.

Relevant text from PAR-24-272 found in: Section I. Notice of Funding Opportunity Description → Resources provided by NCATS

For Element E: Clinical and Translational Science Research Program, what is the duration of each study? Is there a minimum and a maximum?

The suggested period of a project in Element E: Clinical and Translational Science Research Program is two to three years. The maximum length of a project is seven years, the same length of the UM1 award.

Relevant text from PAR-24-272 found in: Section I. Notice of Funding Opportunity Description → Element E: Clinical and Translational Science Research Program

Element E: Clinical and Translational Science Research Program states that a single initial CTS project must be described. Does this mean only one project can be described (e.g., not more than one)? What does “described” mean in this context?

At least one CTS project must provide a detailed description of the project, and additional projects may be suggested or discussed in the application. NIH would consider a project with a detailed description to provide content consistent with the requirements as described in the Research Plan section of the NOFO. This includes detailed Specific Aims, Innovation, Significance and Approach similar to traditional NIH research project grant applications (e.g., R01, other).

Relevant text from PAR-24-272 found in: Section I. Notice of Funding Opportunity Description → Element E: Clinical and Translational Science Research Program

Relevant text from PAR-24-272 found in: Section IV. Application and Submission Information → PHS 398 Research Plan → Element E: Clinical and Translational Science Research Program

For Element E: Clinical and Translational Science Research Program (CTS RP), the translational science projects are described as being $125,000 each and can last two to three years. Does this mean $125,000 in direct costs? Is this per year or over the life of the project?

Each CTS project may not be less than $125,000 per year in direct costs and is suggested to run for two to three years. Furthermore, the overall CTS RP may not exceed $500,000 per year in direct costs.

Relevant text from PAR-24-272 found in: Section IV. Application and Submission Information → R&R Budget → Element E: Clinical and Translational Science Research Program

For Element E: Clinical and Translational Science Research Program, does each project get six pages, or is the page limit for Element E six pages?

Element E is limited to six pages for the description of the Clinical and Translational Science Research Program.

Relevant text from PAR-24-272 found in: Section IV. Application and Submission Information → Page Limitations

For Element E: Clinical and Translational Science Research Program, how many research program leaders can there be? If there are four projects, should there be four research program leaders?

Any Element may have co-leaders (two leaders). It is not required that a CTS project PI be the leader of the overall Clinical and Translational Science Research Program.

Relevant text from PAR-24-272 found in: Section I. Notice of Funding Opportunity Description → CTSA Program UM1 Hub Application Structure

Should applicants include a description of individual projects that will be pursued in the Clinical and Translational Research Program?

Yes. Each hub is required to request at least one discrete research project in the application with an associated and defined budget. Additional “sample” or “example” projects may be provided as long as at least one discrete research project is provided with an associated and defined budget. Additional projects could be ones that, for example, will be performed initially in tandem with the project described in detail or later in the award cycle (e.g., built upon discoveries from an initial project).

Relevant text from PAR-24-272 found in: Section IV. Application and Submission Information → PHS 398 Research Plan → Element E: Clinical and Translational Science Research Program

For Element E: Clinical and Translational Science Research Program, can applicants collaborate with other hubs?

There are no restrictions on collaborating with other hubs on Element E CTS Projects.

What are the page limits for Element E, and is the page limit dependent on how many research projects are described?

The page limit for the Element E Clinical and Translational Science Research Program is 12 pages and the page limit is fixed, not dependent on how many projects proposed.

Question from Section IV. Application and Submission Information, 2. Content and Form of Application Submission, SF424 (R&R) Other Project Information, Other Attachments: Clinical Trial Experience:

The Clinical and Translational Science Track Record is a required attachment for the application. Applicants may use suggested Template Data Table formats described in the CTSA Program Summary Data Guide (CPSDG) or similar table formats. All fields shown in the CPSDG must be completed. This information is used to demonstrate the clinical trial experience of the institutions involved in the UM1 application and likely to participate in clinical trials. Given the page limit, applicants are encouraged to prioritize trials with which the applicant institution was engaged and trials that show a breadth of expertise.

Resources that may be of use are listed on the website ClinicalTrials.gov and its Glossary of Common Site Terms.

When is the six-month window for reporting?

The six-month window is up to and prior to the application. Applicants should indicate the time frame they are reporting.

Do applicants need to include all reportable studies at the CTSA hub and partner institutions, or only those in which the CTSA was involved?

This information is used to demonstrate the clinical trial experience of the institutions involved in the UM1 application and likely to participate in clinical trials. Include NIH-funded single- or multisite clinical trials that showcase the breadth of clinical trials experience at the hub. Given the page limit, applicants are encouraged to prioritize trials with which the applicant institution was engaged and trials that show a breadth of expertise.

Column “Funding Source”: The table instructions are to include only NIH-funded trials. However, footnote #4 instructs applicants to enter “institutional, grant, contract and/or nonprofit.” Does this mean that trials supported through other funding sources can be included?

Studies funded by other sources also can be included to show the breath of science/trials at the hub.

What should be included in the “Months from Actual Start/Completion Date” column?

Period (in months) since the project started or was completed. From ClinicalTrials.gov, Glossary of Common Site Terms.

Study start date: The actual date on which the first participant was enrolled in a clinical study. The “estimated” study start date is the date that the researchers think will be the study start date.

Study completion date: The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (i.e., the last participant's last visit). The “estimated” study completion date is the date that the researchers think will be the study completion date.

For multisite trials, should the “Actual Cumulative Enrollment” column include only enrollment at the hub (and partner and collaborator sites) or all participating sites?

Yes. You may report enrollment at the hub (and partners and collaborators) and specify in the table which enrollment (hub or total) you are reporting on.

For the “Primary Endpoint Result Indication” column, is reporting the study primary endpoint(s) sufficient?

Report primary study endpoint, which may be extracted from the study registration in Clinicaltrials.gov.

PubMed Identifier (PMID) or abstract: The table does not include columns for all items included in the instruction text below it (PMID, impact statement). Please clarify.

The suggested table format likely does not have sufficient room to include a column for an overall impact statement and reference to the PMID. Thus, applicants are encouraged to add this information below the table.

If text is added below the table, does it count toward the five-page limit for this attachment?

The page limit for the Selected Clinical Trial Experience is five pages, inclusive of the overall impact statement for each clinical trial and study and reference to any PMID or abstract.

PMID or abstract: It seems unlikely that studies activated within the six months prior to submission of the CTSA application will result in publications during this timeframe. Is it permissible to include publication information for any preliminary studies related to the clinical trial?

Yes.

Question from Section IV. Application and Submission Information, 2. Content and Form of Application Submission, SF424 (R&R) Other Project Information: Is this the only place to describe all the resources available at the institution, partners and collaborating institutions?

There are two places in the application where Resources and Facilities may be described:

1. Table in Other Attachments: The Resources to Achieve CTSA Objectives Table must be included to aid in the review of applications. This table will provide a listing of specific resources that are anticipated to be used during the performance period of the UM1 and is limited to five pages. Information provided in the required attachments should not be repeated in the narrative.
2. Facilities and Other Resources Attachment in the R.230 — Project/Performance Site Location(s) Form: Provide an explanation of resources available from each project/performance site on the “Facilities and Resources” attachment of the R.220–R&R Other Project Information Form. The “Facilities & Other Resources” attachment is required. It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this NOFO or in a Notice from NIH Guide for Grants and Contracts).

Question from Section IV. Application and Submission Information, 2. Content and Form of Application Submission, SF424 (R&R) Other Project Information, Other Attachments: Should the CTS track record accomplishments be focused on the hub activities or on the applicant institution’s track record?

Applicants are referred to the review criteria:

• To what degree do the applicant and any partner(s) and/or collaborator(s) have a strong record of CTS research with high-impact achievements in useful methods and procedures leading to improved diagnoses, treatments and strategies for disease prevention?

Relevant text from PAR-24-272 found in: Section IV. Application and Submission Information → SF424(R&R) Other Project Information → 6. Clinical and Translational Science Track Record

How many of each companion application can a UM1 applicant or awardee submit?

PAR-24-272 only accepts applications that are part of a collaborative set of multiple applications, although the only applications that are required are the UM1 NOFO (PAR-24-272) and one application for the K12 (see NOT-TR-24-008). The other companion applications are optional (T32, R25, and RC2) and have the following limits in terms of how many may be submitted or awarded in connection to the primary UM1 application or award:

• One application to the Predoctoral T32 (see NOT-TR-24-008): Limited Competition: Ruth L. Kirschstein National Research Service Award (NRSA) Predoctoral Research Training Grant for the Clinical and Translational Science Awards (CTSA) Program (T32 Clinical Trial Not Allowed)
• One application to the Postdoctoral T32 (see NOT-TR-24-008): Limited Competition: Ruth L. Kirschstein National Research Service Award (NRSA) Postdoctoral Research Training Grant for the Clinical and Translational Science Awards (CTSA) Program (T32 Clinical Trial Not Allowed)
• One application to the R25 (see NOT-TR-24-008), PAR-21-339: Limited Competition: NCATS Clinical and Translational Science Awards (CTSA) Program Research Education Grants Programs (R25 - Clinical Trial Not Allowed)
• Two applications to PAR-24-054: Limited Competition: High Impact Specialized Innovation Programs (SIPs) in Clinical and Translational Science for UM1 CTSA Hub Awards (RC2 Clinical Trials Optional)

Note the following:

• The required K12 and any companion optional applications will be awarded only if the UM1 application is awarded.

Do UM1 applicants have to apply for all companion NOFOs simultaneously, or can companion applications be submitted in the future?

Companion optional applications may be submitted in accordance with the applicable NOFO application submission dates under the following scenarios:

• Concurrently with the UM1
• While the UM1 application is under review consideration
• After the UM1 application is funded
• While the UM1 is under consideration for funding

While optional companion applications may be submitted concurrently with the UM1 application or at any time the submitted UM1 new or resubmission application remains active, optional companion applications will only be awarded if the UM1 is awarded.

Relevant text from PAR-24-272 found in: Section III. Eligibility Information → Additional Eligibility Requirements

How should companion applications be described in the UM1 if they are not submitted simultaneously with the UM1 application?

UM1 applications should indicate that applications are planned in the future and should describe the intent or plans to coordinate and integrate these activities with the UM1. The companion NOFOs also have a requirement for a Coordination and Interaction Plan to be added to the application that will provide the current plans.

Is the Element E research project distinct from the RC2 research project?

Yes. The CTS Research Program includes CTS research projects that are distinct projects that the hub will propose as part of its UM1 and that will address a specific question or set of questions in clinical and translational science and how the project(s) will provide generalizable innovations or insights that increase the overall efficiency or effectiveness of translation. The SIPs are specialized resources/activities that will help support clinical and translational science projects/studies locally. A UM1 research project may need specialized support for a specific portion(s) of the project, and this specialized resource could come from the hub’s SIP. For example, a hub may have specialized activities/resources in the integration of mobile technologies for enrollment and follow-up of clinical research participants. Expertise and capabilities are deployed within the hub for different types of studies that are ongoing or in the process of being planned. The resource is then provided to the community of investigators at the hub to support their specific studies. The resource is widely available, and results of the utilization, projects and outcomes are tracked over time.

How do applicants describe their interactions with the required K12 (NOT-TR-21-030) and any other optional companion applications?

Relevant text from PAR-21-293 (Section IV. Application and Submission Information, 2. Content and Form of Application Submission, SF424 (R&R) Other Project Information, Other Attachments) — Coordination and Integration Plan (use filename Coordination and Integration Plan): The application must include a specific plan describing the partnership between the UM1; the required K12 and any optional components, such as the research education (R25); and/or pre- and postdoctoral training (T32) awards. The UM1 application must describe the overarching goals of each component and the coordination, integration, synergy and mutual reinforcement of resources between the components. Include a description of the roles of any shared partners and/or collaborators. Limited to three pages.

Are the Coordination and Integration Plans required to be identical for the UM1 and the K12?

No. The Coordination and Integration Plans are not required to be identical for the UM1 and the K12.

Can the UM1 budget request personnel support for the required and optional companion training and education activities?

Yes.

Relevant text from PAR-24-272 found in: Section IV. Application and Submission Information → R&R Budget → Element C: Training and Outreach

Can the K12 be resubmitted without the required UM1?

Yes. The K12 Physician Scientist Award Program required companion application may be resubmitted in accordance with the applicable NOFO application submission dates under the following scenarios:

• Concurrently with the resubmitted UM1
• While the UM1 application is under review consideration
• After the UM1 application is funded
• While the UM1 is under consideration for funding

Note that the K12 Physician Scientist Award Program required UM1 companion application must be submitted in accordance with the UM1 and K12 NOFOs application submission dates under the following scenario:

• Initial concurrent submission of both a UM1 application and a K12 application

Can one of the UM1 partner/partnering or collaborator/collaborating institutions be the applicant institution for any required (K12) or companion (T32, R25, RC2) applications?

No. Only the primary UM1 hub institution is eligible to apply for a K12, T32, R25 or RC2.
Please note that NIH requires that the prime award recipient perform a substantive role. 

With a multiple-PI application/model, are three to six months’ effort preferred per PI?

Yes. All PD(s)/PI(s) must each commit at least two months and preferably three to six months effort to the award

Relevant text from PAR-24-272 found in: Section III. Eligibility Information → Eligible Individuals (Program Director/Principal Investigator)

Can applicants include specific aims for each Element?

No. There is a single Specific Aims (one page), and it is separate from the Research Strategy for the Elements, with one exception. The Element E CTS Research Program must include Specific Aims for the detailed description of a project in the Research Strategy for Element E.

Relevant text from PAR-24-272 found in: Section IV. Application and Submission Information → PHS 398 Research Plan → Specific Aims

Relevant text from PAR-24-272 found in: Section IV. Application and Submission Information → PHS 398 Research Plan → Element E: Clinical and Translational Science Research Program

Is the following statement incorrect? “Project/Performance site locations: the NOFO instructions state to only include the primary site and that a summary will be generated from data collected in other components. However, there are no other components in the UM1 mechanism.”

The statement seems to be a holdover from previous CTSA FOAs and should be disregarded for the UM1.

Since the UM1 is a single application, applicants will need to follow the instructions in the Research Instructions for NIH and Other PHS Agencies: SF424 (R&R) Application Packages (pages R-46 through R-49) and list all the relevant Project/Performance Site Locations for the UM1.

The Project/Performance Site Locations form allows for the collection of multiple performance sites. If you need to add more project/performance site locations than the form allows, enter the information in a separate file—the Additional Performance Site Format form—and upload it to the “Additional Locations” section.

Can individual Modules and Elements have more than one Leader?

Any Element or Module may have two Co-Leaders. An individual may have more than one Leader role.

Note: The NOFO does not require Element Leaders (and was not intended to have Element Leaders).

Relevant text from PAR-24-272 found in: Section I. Notice of Funding Opportunity Description → CTSA Program UM1 Hub Application Structure

How much effort is required for a Module or Element Leader?

PAR-24-272 provides no guidance as to the level of effort required for Module Leaders. Leader effort should be commensurate with the anticipated role and responsibilities described in the budget justification. However, applicants are reminded to review the instructions for cost share, as “This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement.”

Is it true that, given the new structure of the UM1, there will only be one place to upload Letters of support? If so, should applicants just reference the corresponding Element in the letter itself?

Yes. There will be only one place to upload the letters of support for the UM1 application. Please make sure to reference the corresponding Element if appropriate. Applicants are encouraged to limit the number of letters of support to no more than 30.

Relevant text from PAR-24-272 found in: Section IV. Application and Submission Information → PHS 398 Research Plan → Letters of Support

Is dissemination going to be considered as part of promoting partnerships and collaborations to facilitate and accelerate translational research projects locally, regionally and nationally?

Applicants are directed to the text in the NOFO regarding “dissemination” and to the following text in the NOFO:

Relevant text from PAR-24-272 found in: Section V. Review Information → Scored Review Criteria → Significance → Specific to this NOFO

Relevant text from PAR-24-272 found in: Section VI. Review Information → Cooperative Agreement Terms and Conditions of Award → The PD(s)/PI(s) will have the primary responsibility for

It is understood that hyperlinks are not allowed in the application; however, would NCATS please confirm if applicants are allowed to keep URLs in the References?

Throughout the Research (R) Instructions in the SF424 (R&R) Application Guide, applicants are reminded that “Use of hyperlinks and URLs in this section is not allowed unless specified in the notice of funding opportunity.”

Regarding the Exception for Biosketches, please refer to: Biosketch Format Pages, Instructions and Samples.

• Instructions for Biographical Sketch — Clarifies when and how a URL may be used in a biosketch. The only allowed hyperlink/URL is for a full list of published works.
• Applicants may provide a URL to a full list of their published work. This URL must be to a federal government website (with a .gov suffix). NIH recommends using My Bibliography. Providing a URL to a list of published work is not required.
  • The URL is the specific web address written out in the text. The hyperlink is a dynamic piece of code attached to the text that may have a URL different from the visible text. URL is okay (if allowed) because it can be copied and pasted into a web browser. A hyperlink (active link) is not allowed.

PAR-24-272 reads: “Applications that are part of a collaborative set must include a listing of all the applications that are a part of the set of collaborative applications being submitted, including for each: 1) the PD(s)/PI(s) name(s), 2) the NOFO number, 3) the Title of the application, and 4) the Applicant Institution. Each application that is part of the collaborative set should submit an identical listing.” Are the UM1, required K12 and any companion applications required to have the same title? 

Slight variations with the title of the application are acceptable. The purpose of the instructions in the NOFO is to help staff match the applications in a collaborative set. Please follow the NOFO-specific instructions as provided.

How can references be assigned to different Elements or Modules?

The Bibliography & References cited may be organized and listed by Element/Module to improve readability.

Do the Modules under each Element have to be described in the same order as described in the NOFO?
(Reference: UM1 FOA Diagram)

No. The Modules do not have to be provided in the application in the same order as described in the NOFO. Changing the sequence of the Modules is acceptable if all Modules for the Element are included in the application.

Will study section members have access to all grant applications submitted (UM1, K12, T32, R25, RC2) in the CSTA suite of awards for the same application date?

Applications should not expect reviewers to have access to all the grant applications submitted, as the NOFOs may be reviewed within different study sections (special emphasis sections). Currently, there are three distinct special emphasis panels for the:

• UM1
• RC2
• T32, R25, K12 mechanisms

Applications should be complete so that a reviewer will have all necessary information for a thorough evaluation of the application. Reviewers will have access to only the applications being reviewed in their special emphasis panels. Information from other applications being reviewed in the special emphasis panels will not be considered during the assessment and review of any specific application.

The Coordination and Integration Plan required for each NOFO provides an opportunity to describe the partnership between the mechanisms. The application must describe the overarching goals of each component and the coordination, integration, synergy and mutual reinforcement of resources between the components. Include a description of the roles of any shared partners and/or collaborators.

Who must complete the “Biographical Sketch” section?

Follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide and on the Biosketch Format Pages, Instructions and Samples page, noting the following:.

• All senior/key personnel and other significant contributors (OSCs) must include biographical sketches (biosketches).
  • OSCs: Individuals who have committed to contribute to the scientific development or execution of the project but are not committing any specified measurable effort (i.e., person months) to the project. These individuals are typically presented at “effort of zero person months” or “as needed.” Individuals with measurable effort may not be listed as OSCs. Consultants should be included if they meet this definition.
  • Senior/key personnel: The PD/PI and other individuals who contribute to the scientific development or execution of a project in a substantive, measurable way, whether or not they receive salaries or compensation under the grant. Typically, these individuals have doctoral or other professional degrees, although individuals at the master’s or baccalaureate level may be senior/key personnel if their involvement meets this definition. Consultants and those with a postdoctoral role also may be considered senior/key personnel if they meet this definition. Senior/key personnel must devote measurable effort to the project whether or not salaries or compensation are requested. “Zero percent” effort or “as needed” are not acceptable levels of involvement for those designated as senior/key personnel.
• Biosketch Personal Statement: Briefly describe why you are well-suited for your role(s) in this project. Relevant factors may include aspects of your training; your previous experimental work on this specific topic or related topics; your technical expertise; your collaborators or scientific environment; and/or your past performance in this or related fields, including ongoing and completed research projects from the past three years to which you want to draw attention (previously captured under Section D. Research Support).

How should I include clinical trials in my application?

Please see NIH’s Definition of a Clinical Trial.

Please note that misclassified clinical trial applications may be withdrawn. Applicants are strongly encouraged to consult with appropriate Program Staff for guidance. A human subjects research study meets NIH’s Definition of a Clinical Trial if a research study in which one or more human participants are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on the participants, and the effects being evaluated are health-related biomedical or behavioral outcomes. For help with NIH’s definition of a clinical trial, please see Does Your Human Subjects Research Study Meet the NIH Definition of a Clinical Trial?

As a reminder, for CTSA (UM1 Clinical Trial Optional) (PAR-24-272) applications, all applicants must answer “Yes” to the involvement of Human Subjects during the period of award and complete all related sections. Applications that do not answer Yes to the involvement of Human Subjects and complete all related sections are incomplete and will not be reviewed.

Since the CTSA (UM1 Clinical Trial Optional) (PAR-24-272) supports clinical and translational science pilots (Element D: Clinical and Translational Resources & Pilots, Clinical and Translational Pilot Module) and at least one translational science research project (Element E: Clinical and Translational Science Research Program), it should be anticipated that research projects involving clinical trials might be initiated during the seven-year grant period. If there is any potential for research projects involving clinical trials to be initiated during the seven-year grant period, then appropriate information must be provided. Note for Element E at least one initial, discrete and clearly defined clinical and translational science research project, inclusive of a detailed budget for that project, is required. As a reminder, if any part of the application (Element D and/or Element E) meets, or could meet, the definition of a clinical trial, then the entire application should be submitted accordingly.

Therefore, please read the following reminders carefully:

Delayed Start: A research project that can be described at time of application, but research will not immediately begin (will occur later in the funding period). For delayed start studies, applicants should add a study record for each proposed study involving human subjects. As such, the four questions in the clinical trial questionnaire need to be answered “Yes” if the delayed start study involves NIH-defined clinical trial.

• This will occur with the project(s) under Element E: Clinical and Translational Science (CTS) Research that can be described at the time of application.

Delayed Onset Study: A research project that is anticipated within the period of award, but definite plans are not yet known and cannot be described in the application. For delayed onset studies, all applicants should check the Anticipated Clinical Trial box and complete all related sections. Please see the instructions in G.500 PHS Human Subjects and Clinical Trials Information. Consistent with NOT-OD-15-129, delayed onset projects will undergo prior approval (See more information here: Prior Approval Requests for Human Subjects Research).

• This will occur with pilots under the Element D: Clinical and Translational Resources & Pilots.
• This will occur with the project(s) under Element E: Clinical and Translational Science Research Program if the project(s) cannot be described at the time of application.
• This will occur with described project(s) under the Element E: Clinical and Translational Science Research Program if the described project(s) are not delayed start.

For applications involving clinical trials, please see additional review criteria stated in the PAR-21-293.

As applicants may describe varying start times during the seven-year UM1 award for the study/studies, NCATS may request additional information during Just-In-Time procedures or later in the project period to further assess safety of a delayed start study.

Who can address any additional questions?

Please email us questions regarding Application Information for PAR-24-272.