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Clinical and Translational Science Awards

CTSA Program PAR Frequently Asked Questions

Questions and answers for PAR-15-304 are applicable to PAR-18-464.

Budget and Funding

Application Information

Training and Career Development

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Budget and Funding

Are subaward recipients permitted to charge indirect costs for pilots and clinical studies?

Yes; however, the applicant institution must establish consortium agreements consistent with the applicable government-wide cost principles and NIH cost policies.

Are there any restrictions on indirect costs applied to pilots and clinical studies?

Applicant institutions must use an approved, federally recognized indirect cost rate negotiated between the subaward recipient and the federal government. If no such rate exists, the applicant institution must use either a rate it has negotiated with the subaward recipient, or a de minimis indirect cost rate of 10 percent of modified total direct costs if the subaward recipient has never received a negotiated indirect cost rate from the federal government.

Are CTSA Program institutions responding to PAR 15-304 being asked to publish a comprehensive list of clinical charges with cost-center based application of the DHHS Rate Agreement? Or, are they instead supposed to supply a list of charges only for research (i.e., nonclinical) items that might be associated with NIH multisite clinical trials?

No. CTSA Program institutions responding to PAR-15-304 are not being asked to publish a comprehensive list of clinical charges with cost-center based application of the DHHS Rate Agreement. Although CTSA Program institutions are asked to maintain a transparent cost structure for translational research projects supported by the CTSA Program, the DHHS rate agreement may or may not be applicable to this cost structure depending on your organization and the activities supported. The guidance in the PAR-15-304 concerning institutional letters of support requests assurance that the applicant institution will work under a central IRB, use master subcontract agreements/trial agreements, and will work under a transparent cost structure for research items associated with multisite clinical trials (e.g., per patient costs) supported by the CTSA Program. The negotiated patient care rate agreement between a CTSA Program institution and the DHHS is a separate fiduciary document used to determine reimbursement rates for services performed for research purposes using federal funds.

Based on the funding opportunity announcement (FOA) guidance, how much funding is available to a specific applicant? Based on a current award of $7,219,327 (total costs), which is more than $3 million plus $2,165,798, would an institution be eligible for the phase-in plan? If so, how are the direct cost numbers determined for years one to three?

In determining the appropriate budget calculation, grantees should first determine any and all partner organizations associated with the hub institution. Secondly, use the table provided (Excel - 113KB) to determine the maximum budget (2.5 percent of NIH direct costs) that can be requested for the UL1 and KL2 awards.

The most recent facilities and administrative (F&A) rate should be applied to the direct costs on the UL1, and the F&A rate of 8 percent should be applied to the direct costs on the KL2 to determine the total anticipated award for the application. If the total anticipated award for the new application is less than the prior CTSA Program award for U and K total costs (excluding supplements and carryover) by more than 30 percent, the phase-in plan should be used. Depending on the amount of discrepancy between the prior CTSA Program award and the current budget calculated in response to PAR-15-304, it may be possible to reach the maximum cost within the first two years of the grant by applying the phase-in plan.

Are the direct costs of subcontracts for participating institutions excluded from the direct cost cap of $7.5 million?

No, all direct costs for the parent grant and any sub-award agreements are included in the direct cost cap. Sub-award facilities and administrative costs are excluded from the direct cost cap.

Certain sections have direct cost caps based on the size of the CTSA Program hub. Is there flexibility to re-budget between these sections such that the overall total is at the $7.5 million cap?

There is flexibility. The amounts listed in this funding opportunity are “suggested,” and the PAR states, “The budget will depend on the development needs for each hub to reach the strategic goals.”

Are no-cost extensions permitted under the CTSA Program? Can a no-cost extension be requested on all linked awards including the K and T?

Yes, all NIH grants are subject to the NIH Grants Policy Statement, which permits grantees to extend the final budget period of the previously approved project period once for up to 12 months beyond the original completion date shown in the Notice of Award. No additional funds are required to be obligated by the NIH awarding Institute or Center, and the originally approved scope of work will not change. No new scholars or trainees can be appointed in an extension period.

Is there any guidance on which Facilities and Administration rates to apply? What rate should be applied on the U54? Should the standard 8 percent be applied to the KL2 and the TL1?

Check with your Office of Sponsored Research for guidance on your institutional facilities and administration rate. For the KL2 and TL1 components, recipients will receive F&A costs at 8 percent of modified total direct costs.

Will any escalations to salary or fringe benefits be awarded? Or should both be static across all five years of the proposed budget?

No, NCATS will not award inflation-driven increases to salary or fringe benefits in subsequent budget years.

What is the appropriate reference to determine how much support may be requested in response to this PAR?

In compliance with NIH policy, the PAR-15-304 now has to refer to direct cost rather than total cost. The amounts up to which support may be requested are in the same range as they were in RFA-TR-14-009, but now are expressed in direct cost. The statement provided in the "Administrative Core" budget section along with the table referenced therein refers to direct cost.

What is the appropriate reference to calculate the CTSA Program budget for the U and K components of PAR 15-304?

Applicants must use the direct-cost, institutional NIH funding link provided in the PAR under the Budget (Administrative Core) section to calculate the budget for the U and K components. Direct-cost support is limited to 2.5 percent of the entire NIH direct-cost funding to the institution in the fiscal year prior to the time of application.

When is the NIH direct-cost, institutional NIH funding link (prior FY award data table) referenced in the PAR updated to reflect the prior fiscal year?

Due to NIH requirements for end-of-year closing, the link generally is updated in February each year. This means that applications submitted for the January 25 receipt date will not be able to use the data from the most recent fiscal year. For example, applications submitted for the January 2018 receipt date will use the link provided in the PAR that will populate data from FY 2016. Any updates to the NIH funding link will be made directly to the PAR.

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Application Information

Are websites and website URLs allowed in the narrative sections of an application to CTSA Program PAR-15-304?

According to the PHS SF424 guidance, “Unless otherwise specified in an NIH solicitation, internet website addresses (URLs) may not be used to provide information necessary to the review because reviewers are under no obligation to view the internet sites. Moreover, reviewers are cautioned that they should not directly access an internet site as it could compromise their anonymity.

Should current and potential grantees submit applications as “renewal,” “new” or “resubmission?”

The PAR allows renewal applications only from institutions that were funded under RFA-TR-14-009 or the current PAR-15-304. Applications from institutions that currently have a CTSA Program award funded under any other FOA will be considered as new applications.

Are current grantees required to submit their progress reports with new applications?

For “new” applications, reviewers will not have access to progress reports, and the following content is not allowed anywhere in a new application or its associated components (e.g., the appendix, letters of support, other attachments):

  • Introduction page(s) to respond to critiques from a previous review
  • Mention of previous overall or criterion scores
  • Mention of comments made by previous reviewers
  • Responses to a prior review
  • 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
  • Progress Report
  • Progress Report Publication List

Can a letter of support mention more than one component (i.e., Informatics and Community and Collaboration) and be attached under each component’s “Letters of Support” section?

General letters of support for the CTSA Program should be submitted with the Overall component in ASSIST (limit of 30 letters). Letters of support that specifically mention individual components (i.e., Informatics and Community and Collaboration) can be submitted under each of the components mentioned. Note that 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.

Can the “Pilot Translational and Clinical Studies (PTC)” under “Translational Endeavors” be completely supported by the institution?

No. Translational Endeavors is a required component of the U54 application. If the institution opts to utilize other institutional resources to support a larger entity than is required by the FOA, the additional funding support will be considered voluntary cost sharing. Awarded grantees must ensure that voluntary cost sharing commitments are appropriately tracked, monitored and reported.

How should “additional support” be presented in the application, and how is it different from cost sharing? Can additional support be quantified?

The current FOA does not require cost sharing. Additional support provided by the grantee and partner institutions should be described in a non-quantitative format in the letters of support. Institutional commitment also can be presented in a non-quantitative format in the Resources section of the application. Voluntary institutional commitment should not be reported in the application Budget Forms or Budget Justification. Any quantitative, itemized (voluntary) institutional commitment reported in the application will be considered cost sharing. Cost sharing is not permitted on the TL1 and KL2 core components.

PAR-15-304 indicates that travel to support up to five participants to attend the annual CTSA Program Steering Committee meeting is allowed and should be budgeted in the Administrative Core budget. In addition, travel for the TL1 Project Lead is allowed on the Administrative Core budget. Is this the only travel funding allowed on the UL1 portion of the U54?

The expectation is that administrative operations will be streamlined so that the direct cost for administration does not exceed 10 percent of the total UL1 direct costs. Therefore, discretion should be exercised in determining travel allowances beyond what is specified under the Administrative Core budget and supported with a strong justification.

As an existing CTSA Program hub submitting a “new” application, may we include a publication list?

Yes, you may include publications within the page limit restrictions for each core component. According to the PAR, publications are requested particularly in the Overall Core and under the program plan for the Institutional Career Development Core and the Training Core. However, you must follow the page limit guidelines for submitting publications. The publication list submitted with your institution's Research Performance Progress Report is not permitted.

Does the 30-letter limit for letters of support apply to all sections (i.e., U + K + T = 30 total)?

No, each core component of the U54 application has a separate upload in ASSIST for letters of support (including the K and T cores). Only the Overall component limits the number of general letters of support as defined in the PAR to 30 letters.

If human subjects (HS) and vertebrate animal (VA) subjects are used in two components, do we need to attach a description of how HS/VA research is handled for the entire application in the Overall Component or upload attachments specifically under the two components conducting HS/VA research?

Under each core component, applicants will need to answer the questions, “Are human subjects involved?” and “Are vertebrate animals used?” in the R&R Other Project Information form of ASSIST. If an applicant answers “Yes” to either question, he/she must attach a component-specific response. If neither HS nor VA are used in a specific component, answer “No” to the questions as applicable, and there are no accompanying attachments required for those components.

Additionally, if HS or VA involvement is endorsed in any component of the entire U54 application, the applicant should answer “Yes” to the questions, “Are human subjects involved?” and “Are vertebrate animals used?” in the R&R Other Project Information form under the Overall component. In this case, an attachment should be uploaded under the Overall component describing the institutional policies on protections for HS and VA welfare for the entire application.

For the K and T components, please follow the detailed guidance in SF424 (R&R) Application Guide Training Instructions.

What is the appropriate clinical trial designation, time frame, and activation parameter to include in the NIH-Defined Phase III Clinical Trial table?

The NIH definition of a Phase III Clinical Trial, as pertains to the review of applications submitted to the NIH is referenced under the glossary of terms. The guidance provided in the PAR concerning the time frame for reporting “trials activated “ is the first half of the calendar year (January – June) prior to the application submission date. Reporting metrics for the table are not limited to NIH-funded research. Therefore, you may use your discretion to include clinical affiliates within the six-page limit designated for the Network Capacity Core. The site activation parameter for investigator-initiated, single-site studies is the date of IRB approval and for multisite studies, it is the date when the site is activated by the sponsor.

The previous RFAs for the CTSA Program grant mandated 20 percent effort for the principal investigator (PI) and co-directors. This mandate is not listed in the current FOA. Do the PI and co-directors still need to account for a minimum of 20 percent effort?

No. The equivalent of two months effort is the official guidance referenced in the PAR under Section III. Eligibility Information: “The CTSA Program PDs/PIs are each expected to commit at least two months and preferably three to six months effort to the award.”

What allowable materials can applicants place in the appendix of the U54 application?

Effective Jan. 25, 2018, the NIH/AHRQ/NIOSH policy eliminates most former allowable appendix material for applications.

Are the “Specific Aims” (one-page limit) in addition to and separate from the “Research Plan” (six-page limit)?

According to PHS SF424 instructions, the “Specific Aims” section is a separate (one-page) document not included with the “Research Plan.” The Specific Aims page requires a separate upload into the NIH ASSIST system. Unless specified otherwise in PAR 15-304, the page limits should follow those referenced by PHS SF424.

For “Optional Functions,” the page limitations table lists six pages as the limit for this component. If two optional functions are being proposed, can each function be six pages long (12 pages total), or do they need to be six pages total? Also, should each function be uploaded separately in ASSIST with a distinct title to differentiate between the two optional functions?

Up to two optional functions may be included in the “Optional Functions” Core. Each proposed function is allowed six pages for the research plan. Each research plan should be uploaded separately in the NIH ASSIST system, with a distinct title to differentiate between the two optional functions.

What is the difference between a renewal and a resubmission application?

A renewal applicant seeks support for a current or recent previously-funded program. A resubmission application is an amended version of a previously submitted application.

If an application in response to RFA-TR-14-009 was unsuccessful and will be submitted again, is it required to address the previous review comments?

An applicant who applied under RFA-TR-14-009 can choose to submit his/her application as a resubmission or as a new application. If the applicant chooses to resubmit, reviewers will have the previous summary statement, and the applicant will need to address the previous comments and include an introduction. If the applicant chooses to submit an application as a new submission, reviewers will not have access to the previous summary statement, and he/she is not allowed to address previous comments from reviewers or include an introduction.

Note that the following content is not allowed anywhere in a new application or its associated components (e.g., the appendix, letters of support, other attachments):

  • Introduction page(s) to respond to critiques from a previous review
  • Mention of previous overall or criterion scores or percentile
  • Mention of comments made by previous reviewers
  • Responses to a prior review
  • 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
  • Progress Report
  • Progress Report Publication List

See NOT-OD-15-059 and NOT-OD-15-095 for additional details.

What is meant by "CTSA Program hubs with more than 16 months of remaining support at the date of submission are not eligible to submit an application"? Please provide an example.

If you have a CTSA Program grant with a May 31, 2018, project period end date, the earliest date an applicant could submit an application in response to this FOA would be Jan. 28, 2017.

Are the page limits specified in this FOA tied to the amount of funds being requested, and are page limits different for those institutions that already have CTSA Program grants?

The page limits specified in this FOA are the same for all applicants, regardless of the amount of funds being requested and whether the applicant already has a CTSA Program grant.

Which biographical sketches should be included in the application?

Applicants should include biographical sketches only for professional staff named in the application who contribute to the program in substantive and measurable ways.

Do applicants need to name project leads for each FOA component as well as for each function?

A project lead must be named for each component (e.g., Research Methods); however, a project lead does not need to be named for each function (e.g., Biostatistics, Epidemiology and Research Design).

What application types are allowed under PAR-18-464 ?

The current FOA allows the following types of applications:

  • New
  • Renewals for RFA-TR-14-009
  • Resubmissions for RFA-TR-14-009, PAR-15-304 and this FOA.

Applications from institutions that currently have a CTSA Program award will be considered as new applications unless:

  • They are resubmissions or renewals of applications submitted to RFA-TR-14-009, or
  • They are resubmissions from PAR-15-304 and this FOA.

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

What is the page limit for the U/K/T CTSA Program progress reports for renewal applications?

Progress Report for Renewal and Revision Applications:

Note that the Progress Report falls within the Research Strategy and is therefore included in the page limits for the Research Strategy. For renewal/revision applications, provide a Progress Report. Provide the beginning and ending dates for the period covered since the last competitive review. In the Progress Report, grantees should:

  • Summarize the specific aims of the previous project period and the importance of the findings, and emphasize the progress made toward their achievement.
  • Explain any significant changes to the specific aims and any new directions, including changes resulting from significant budget reductions.
  • Discuss previous participant enrollment (e.g., recruitment, retention, inclusion of women, minorities, children, etc.) for any studies meeting the NIH definition for clinical research. Use the Progress Report section to discuss, but not duplicate information collected elsewhere in the application.

Do not include a list of publications, patents or other printed materials in the Progress Report. That information will be included in the "Progress Report Publication List" attachment.

Can NCATS confirm that “Equipment” is a required attachment for PAR-18-464?

The “Equipment” attachment is required. Guidance concerning the format and content are referenced in Forms E SF424.

Format: Attach this information as a PDF file.

Content: List major items of equipment already available for this project and, if appropriate, identify the equipment's location and pertinent capabilities.

What format should be used in preparing the multicomponent U54 application?

The current SF424 Instructions clearly state: “Organize the Research Strategy in the specified order, and use the instructions provided unless otherwise specified in the FOA.” In other words, instructions in the FOA supersede the more general instructions in the SF424. Applicants should follow the PAR-18-464 detailed instructions for preparing an application as referenced under Research Strategy e.g., Overall Component. Guidance categories include Vision and Strategic Goals, Track Record in Translational and Clinical Research, Integration of Health Care and Research, and Workforce Diversity.

Can an institution commit to more than one CTSA Program application?

An institution cannot commit to more than one CTSA Program application as a partner. A proposed CTSA Program partnership should be a substantive and unique arrangement, leveraging stakeholders across the translational research spectrum. Additionally, there are budgetary guidelines that limit the total cost for the CTSA Program (U+K component) application. The maximum total amount that can be requested per year for the U and K components is based on total institutional NIH direct costs funding of a single applicant institution, plus the possibility of one or more participating partner institutions. Therefore, if an institution is already a “participating partner institution” with a funded CTSA Program hub, the institution cannot be a “participating partner institution” with another CTSA Program hub for the purpose of calculating the “maximum total amount that can be requested.”

An institution may commit to more than one CTSA Program application as a collaborator.  As a collaborator, the institution would not be able to use their NIH base for the purpose of calculating the “maximum total amount that can be requested.”

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Training and Career Development

Are the recommended number of scholars referenced in PAR 15-304 indicated for the entire grant period? The FOA states: "The recommended number of scholars to budget for in the application is four for small hubs (total anticipated CTSA Program award <$4.5M DC), six for medium hubs (total anticipated CTSA Program award $4.5M-$6M DC), and nine for large hubs (total anticipated CTSA Program award >$6M-$7.5M DC)."

No. The recommended number of scholars to budget for in the application applies to each grant year, not the entire grant project period. For small hubs, applicants may budget for a total of four scholar appointments for each grant year including both new and re-appointments.

Can long-term trainee appointments between pre- and post-doctoral applicants change each year, depending on the pool of applicants keeping the same number of approved slots?

The selection of pre- and post-doctoral appointments must be specified in the application for the entire grant project period (five years). The division of slots may be altered over the course of the grant period in a cost-neutral manner with NCATS prior approval.

Is there a limit on the number of mentors that may be submitted under the Institutional Career Development Core and the Training Core (as applicable)?

No, there is no limit on the number of mentors who may be listed for the Institutional Career Development Core or the Training Core. Participating faculty members should be listed in Table 2 of the required training data tables.

When budgeting for the KL2 program, can the institution supplement the NIH salary up to a level that is consistent with the institution’s salary scale?

Yes, the institution may supplement the NIH salary level so that it is consistent with the institution’s salary scale.

Is budgeting salary support for the Project Lead and staff to support the program allowed as part of the KL2 budget?

Yes, all budget components of the Institutional Career Development Award are included in the KL2 budget, including the Project Lead and staff members.

Is budgeting salary support for the Project Lead to support the program allowed as part of the TL1 budget?

No, the Project Lead and staff salaries (including travel) for the optional Training Core should be included in the UL1 Administrative Core budget. Costs should be reasonable for the size of the training program and well justified. Because these funds will be excluded from the total costs maximum award that can be requested for the U + K components and excluded from the recommended 10 percent limitation for the Administrative Core, applicants must clearly identify the costs associated with the Training Core in their budget justification. Training Core costs directly related to training appointees (stipends, tuition, trainee travel and training-related expenses) should be requested in the Training Core budget.

The budget section of the Training Core (TL) component indicates that in addition to stipends for trainees, training-related expenses also can be requested. May “training-related expenses” include salary and travel support for Training Core Leader(s) and other staff needed to administer the program?

No, the salaries and fringe benefits for the other personnel should not be included in the Training Core component budget, but rather in the UL1 budget section. The NRSA Training Core stipends, tuition, trainee travel and training-related expenses should be requested under the Training Core budget section.

Does the $120,000 per scholar salary support cap include benefits?

No, according to the PAR 15-304 instructions for calculating the salary for scholars (Institutional Career Development Core), you may include support for $120,000 plus fringe benefits. The PAR also states that the average total costs per scholar must not exceed $180,000 in direct costs per year.

What training data tables are required for the T and K components?

K Component Data Table: The updated Forms E SF424 instructions provide a detailed description of the research training tables. The Introduction to the Data Tables linked under the updated Forms E SF424 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/revision) and whether the program includes predoctoral training, postdoctoral training, short-term training, or mixed variations of these categories. The updated Forms E SF424 instructions provide a detailed description of the required data tables.

The descriptive guidance for Scholar Candidates* no longer requests information on the candidate pool, recruitment, nomination and selection. Is this information no longer required?

The Scholar Candidate* information still is required, and applicants should follow the SF424 (R&R) Application Guide instructions referenced under the Training Program Plan —Form E series:

*Substitute the term “scholars” for all references to “trainees” in the SF424 (R&R) Application Guide.

Trainee Candidates

Describe, in general terms, the size and qualifications of the pool of trainee candidates, including information about the types of prior clinical and research training and the career level required for the program. Describe specific plans to recruit candidates and explain how these plans will be implemented (see also "Section C. Recruitment Plan to Enhance Diversity" within the Program Plan). Describe the nomination and selection process to be used to select candidates who will be offered admission to the program and criteria for trainees’ reappointment to the program.

Additional guidance concerning the Recruitment Plan to Enhance Diversity is also provided in the SF424 and should address the comprehensive recruitment effort, including those who are underrepresented in biomedical research. Finally, it is incumbent for applicants to address the Scored Review Criteria as referenced in Section V. Application Review Information for both the K and T components.

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For More Information

What if I have additional questions?

Send your questions via email to CTSAFOAQuestions@mail.nih.gov. Answers in response to emailed questions may be added to this page at a later date.