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FAQ About CTSA RFA-TR-12-006

(Updated December 2012)

Overview

Budget/Funding

Applicant Eligibility

Application Structure

Application Information

Overview

New (Dec. 2012)
NCATS published NOT-TR-12-009 in August 2012, which modified the text in the RFA-TR-12-006 in the Mentored Career Development Program (KL2), part of the Education, Training and Career Development Section. However, the language in this section of RFA-TR-12-006 has not been modified. Which is correct?

The NOT-TR-12-009 modified language is correct and appears below. When NIH publishes a Notice of Clarification, NIH does not modify the language in the original Funding Opportunity Announcement (FOA); instead, a link to the Notice is added in the “Related Notices” section on the FOA’s first page and becomes part of the official document.

Please see the correct information below:

B. Mentored Career Development Program (KL2)

A Mentored Career Development program is a required component of a CTSA. The objectives should be clearly defined and justified based on institutional strengths, the pool of potential scholar candidates and faculty mentors, and synergy (avoiding redundancy) with other NIH funded translational research programs namely the NIH K12 grant mechanism. Justify the proposed number of scholars and explain the criteria used to select, accept, and evaluate candidates. Describe the career development plans for prospective candidates and how plans will be designed to meet the needs of the scholars. Global health research training may be an emphasis area in the KL2 Career Development program, but the K program may not focus exclusively on global health research training. Global health research training programs must be in collaboration with NIH funded investigators. Scholars supported through the KL2 mechanism are expected to be engaged in translational research.

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Does this Funding Opportunity Announcement (FOA) reflect major changes in the Clinical and Translational Science Awards (CTSA) program under NCATS?

This FOA reflects the continued evolution of the NIH CTSA program under NCATS. There has been a new competition for CTSAs each year since 2006, when the program was established. This FOA reflects NCATS’ unchanged commitment to the core features of the CTSA program: the provision of strong infrastructure for clinical and translational research, the development of academic homes for the translational sciences, and the training of the translational research workforce. As with each previous CTSA solicitation, this FOA incorporates recommendations from the public, CTSA investigators, and the broader research community.

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What are the main changes in this FOA?

In response to extensive input, this FOA is designed to provide institutions with greater flexibility and more opportunities to build on institutional strengths. NCATS continues to expect all sites to provide core resources for the entire spectrum of translational research. However, applicants are encouraged to develop programs tailored to meet the needs of their own communities, and to develop and build upon unique institutional and community strengths.

Also, the application is leaner. Applicants are asked to articulate clearly their scientific priorities and strategic vision, effective governance, strong oversight mechanisms, and to establish meaningful ways of tracking and evaluating their supported projects. This FOA does not require the lengthy tables and publications lists included in previous applications.

In addition, applications in response to this FOA from institutions with and without current CTSA grants will be reviewed together.

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Would you share more about the future solicitations referenced in this FOA?

In addition to the Institutional CTSAs, NCATS expects to release one or more CTSA solicitations for potential funding in fiscal year 2014. As noted in the response to the recent RFI, areas of special interest include strengthening community engagement activities and building the capabilities of CTSA consortia to promote networking for national clinical and translational research. NCATS also anticipates working with other NIH Institutes and Centers to provide opportunities for partnerships for CTSA demonstration projects that will support novel processes, methods and models for design, conduct, analysis or dissemination of translational research, including community engagement.

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What do I do if I have questions?

Plan to attend the technical assistance webinar about this funding announcement on July 23, 2012, or send your questions via email to the CTSA FOA Questions mailbox.

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Budget/Funding

How is the maximum budget request determined?

NCATS is moving away from the original historical formula for calculating CTSA budgets, which largely was based on the General Clinical Research Centers program, to a straightforward approach based on NIH funding, similar to other NIH infrastructure awards. For sites with existing CTSAs, this approach will be phased in gradually.

Since total NIH-funded research can vary greatly in scope and scale by institution, CTSA budgets allotted for the integration and support of local research should be scaled accordingly. As such, the new budgetary approach enables NCATS to engage a broad spectrum of institutions while also providing more support to the CTSA institutions that have a large NIH funding base with a substantially larger number of investigators, trainees and research projects to support.

Details for the allowable budget request are as follows:

  • To calculate a maximum budget request, institutions should refer to a table that provides Fiscal Year 2011 total NIH funding to institutions, the most recent year for which we have total funding data. This table also can be accessed in the FOA.
  • The applicant may request up to 3 percent of their total fiscal year 2011 NIH funding, including their partners’ funding, or $4 million, whichever is greater. Existing institutions follow the same guidelines unless their previous budget award exceeds 3 percent of their total NIH fiscal year 2011 funding. If the latter is the case, an institution may initially request the same budget as it received in any one of the last three budget years (Fiscal Years 2010, 2011 or 2012), whichever is greater. However, the budget then will be phased in gradually over the subsequent budget award periods to meet the 3 percent budgetary expectations.
  • Applicants may not request more than $25 million per year in total costs.

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Could you clarify the maximum annual allowable budget request?

The upper limit for allowable total costs (direct and indirect costs) under this FOA is $25 million per year. Thus, the maximum total costs (direct and indirect costs) for a proposed project period of five years is $125 million. This maximum annual budget request is not allowable for all applicants. A particular applicant’s maximum budget is calculated from the sum of the applicant and participating institution FY 11 NIH Funding (using the FY 11 NIH Funding Table). For applicants with a sum of FY 11 NIH funding for applicant and participating institutions greater than $833 million, the annual allowable budgetary request cannot exceed $25 million.

For applicants with a sum of FY 11 NIH Funding for applicant and participating institutions less than $133 million, the maximum allowable total costs (direct and indirect costs) under this FOA is $4 million per year. Thus, the maximum total costs (direct and indirect costs) for a proposed project period of five years is $20 million for such applicants.

The calculated allowable budget request is a maximum and all costs must be justified in the budget request for the proposed activities.

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Is the annual allowable total cost budget request inclusive of all costs?

The calculated annual allowable total cost budget request is the total costs (direct and indirect costs) that may be requested in the composite budget page, which includes all costs from the U, K, and optional T budget pages. Total costs are inclusive of ALL costs; thus, all subcontract, all consortium, and all F & A costs are included. The allocation of budget items across the U, K, and optional T budget pages should match the proposed activities in those areas of the application. Budget justifications should be included in each of the U, K, and optional T budget sections. The composite budget page must reflect ALL proposed budget items from the separate U, K, and optional T budget pages and all costs on the composite budget page must be included on either the U or the K or the optional T budget pages.

Applicants must work with their Office of Sponsored Research to ensure that their proposed budget items and costs are allowable under the NIH Grants Policy Statement. All proposed budget items should be appropriate and justified for the proposed activities described in the application.

The FOA states that it is expected that the provision of resources and services will constitute a significant portion of the requested budget. Additionally, no more than 10 percent of the total NIH CTSA award funds may be allocated for the Translational Pilot Program, thus it is expected that applicants will not propose a budget for the Translational Pilot Program greater than 10 percent of the total costs.

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Can an applicant that requests $4 million total costs in year one, request a 3 percent increase in year two, and similar increases in subsequent years?

For this FOA, inflationary increases may not be requested in subsequent budget years. The NIH does not have funding guidance in place beyond fiscal year 2012; however, NIH has recently reduced or discontinued inflationary increases for future year commitments on funded grants. Therefore, applicants should address how they will modify their program over the proposed project period based on the absence of escalations.

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New (Dec. 2012)
Under the required institutional letters section, the FOA notes that applicants should indicate institutional support for the CTSA program. If the “institutional support” includes direct funding for the CTSA program in addition to that requested in the application, how are these funds noted? Should there be budget page(s) noting how these institutional funds will be used?

There is no requirement for cost sharing or cost matching in this FOA TR-12-006. Institutional commitment is often presented in a non-quantitative manner. However, if a voluntary quantifiable pledge of institutional commitment is included in the application, the costs should be clearly identified in the application separate from the funds being requested from NIH. As Voluntary Committed Cost Sharing, these costs will be reflected as a quantifiable non-Federal share in the Notice of Grant Award if the application is successful. These costs will thus be a binding cost sharing requirement subject to tracking and reporting requirements as well as subject to audit. All costs that are part of Voluntary Committed Cost Sharing must comply with all cost principles as outlined in NIH Grants Policy Statement, applicable Office of Management and Budget circulars, and Code of Federal Regulations.

Again, this FOA has no requirement for cost sharing or cost matching; however, if applicants include a quantifiable institutional commitment, those costs will be treated as Voluntary Committed Cost Sharing as noted above. Policies related to voluntary indications of institutional commitment on grant applications will vary among applicant institutions. Applicants will need to comply with their internal institutional policies and approval requirements at each participating institution. Please consult the applicable Office of Sponsored Projects/Programs for specific institutional guidance prior to submitting applications.

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New (Dec. 2012)
What is the maximum scholar salary allowed for the KL2 component of the application?

For NCATS, the salary costs charged cannot exceed the applicable legislative salary cap. See NOT-OD-12-035 for recent guidance on salary limitations.

Applicants also should refer to the NIH Grants Policy Statement sections on Allowable and Unallowable Costs. Applicants should consult their Office of Sponsored Research as institutional policies and additional federal or NIH regulations may apply at their institution.

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Can the pilot funding for the KL2 Scholars be supplemented with another NIH Career Development Award?

No, each Mentored Career Development Award has a separate budget line item for research pilot funding, which is offered for each scholar appointment period and may not be supplemented with federal funds.

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Is the total number of CTSAs fixed?

The total number of CTSA institutions is not fixed and may increase or decrease depending on the quality of the applications and the funds available.

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Applicant Eligibility

Are applicants with CTSA grants with project period end dates in 2014, 2015 or 2016 eligible to respond to this FOA?

No. Applicant institutions or partner institutions with awarded CTSA grants with project period end dates in 2014, 2015 or 2016 are not eligible to apply in response to this FOA. Eligibility is limited to those that have a CTSA grant with a project period end date in 2013 and to those without a CTSA grant.

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Please describe the eligibility criteria for the Principal Investigator?

The Principal Investigator is expected to:

  • Be an established clinician/scientist who reports directly to an official with broad trans-institutional authority.
  • Have the authority and influence necessary to successfully create an institutional home for clinical and translational research.
  • Have ultimate responsibility for the implementation and function of CTSA and daily involvement with its activities.
  • Commit at least two months and preferably six months effort to the grant regardless of whether salary is requested.

The application should address the qualifications of the proposed Principal Investigator. The suitability of all proposed personnel will be considered as part of the review of the application.

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Are foreign components allowed in response to this FOA?

Non-domestic (non-U.S.) entities (foreign institutions) and non-domestic (non-U.S.) components of U.S. organizations are not eligible to apply and foreign components, as defined in the NIH Grants Policy Statement, are not allowed in response to this FOA. Global health research training may be an emphasis area in the KL2 Career Development program, but the K program may not focus exclusively on global health research training. Global health research training programs must be in collaboration with NIH funded investigators. See NOTICE TR-12-009.

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Application Structure

Why is the application structured differently? Can you explain what the changes are and how this will affect the review of the application?

The application is structured to address the major emphasis areas of the FOA, while allowing applicants the flexibility to structure their program around the special areas of emphasis at their institutions. Applications are to begin with an Overall Strategy and Vision Introduction defining the overall vision for all sections of the proposed Institutional CTSA. Following that, the major sections of the application are the Integrated Home Leadership Section that describes the plans for an enhanced institutional culture and environment for clinical and translational research; the Clinical and Translational Research Resources and Services Section that will provide for research resources and services across the entire spectrum of translational research; and the Education, Training and Career Development Section. Each section has a limited number of pages so applicants must be concise.

The review of the application also is structured differently. Each of the three sections (Integrated Home Leadership; Clinical and Translational Resources and Services; and Education, Training and Career Development) has its own specific review criteria with the overall review criteria addressing evaluation of the entire application.

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Previous CTSA solicitations included sections on required CTSA key functions. Are these key functions required in this FOA?

Applicants have the flexibility to describe how they are going to provide resources and services needed to support the full spectrum of clinical and translational research at their institution.

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How does the new FOA encourage the specific inclusion of child health research in CTSA applications?

NIH has maintained the provision in the current FOA that has allowed for inclusion of a pediatrician principal investigator, with the option of a separate budget for infrastructure for child health clinical research.

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Within the page limits for each section, are there restrictions on how the application is structured?

The applicant is expected to address the proposed activities related to the FOA description of each section within the page limits for that section. However, applicants have flexibility in how they organize the relevant material within the page limits for each section, including use of charts, tables, figures, and text. It is expected that reviewers will focus on material provided within the page limits for the relevant section when evaluating each section; however, reviewers will be encouraged to read the entire application. All page limits are specific for the section, as outlined in the FOA, including for the specific parts of the Education section.

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Application Information

Our institution currently has a CTSA grant, which includes partnerships with two other collaborating institutions. Is it acceptable and or desirable to add other partner institutions in the application in response to this FOA?

In response to this FOA, there are no specified limits on the number of partner institutions that may join the applicant institution in the integrated home for the clinical and translational sciences. However, each institution only can be an applicant or a partner institution on one application in response to this FOA. Applications also should be aware that reviewers will be asked to consider whether the role of each partner institution in the integrated home is clearly described in the application, including how each will benefit significantly from, and contribute to, the integrated home’s creation and function. Applications without effective integration of all partners are not expected to fare well in terms of review and funding decisions.

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Can an applicant include participating institutions that do not have NIH funding in their integrated home?

Yes, applicants can include partners that do not have FY 11 NIH Funding in their application. The annual allowable total cost budget request for such applications is calculated based on the sum of FY 11 NIH funding of applicant and participating institutions that do have NIH funding.

Note that organizations and institutions cannot be part of more than one application whether or not they have NIH funding.

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Are there changes in expectations with regard to informatics or the clinical and translational research environment?

As in previous CTSA solicitations, applicants are expected to establish best practices and an optimal environment for design, review, approval, conduct and dissemination of clinical research. Applicants are to include plans for adoption and implementation of policies and infrastructure that improve quality of human subjects’ protection and promote a culture of responsibility, while minimizing burden and delays. Specifically, this FOA includes a requirement for plans for the adoption and institution-wide implementation of informatics environments (policies and infrastructure) that ensures the security of all data from clinical and translational research involving human subjects at all participating institutions and organizations. Additionally, applicants are encouraged to ensure compatibility of their research systems with broadly accepted content and technical standards, including those adopted by the Department of Health and Human Services for use in U.S. health care and public health operations. As NIH Institutes and Centers adopt common data elements in their domain areas, CTSA institutions should ensure their research tools are compatible.

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What is the maximum number of pilot projects that can be included in the application?

As part of the Integrated Home Leadership section, the applicants must describe their Translational Pilot Program and their proposed guidelines as outlined in the FOA. The application should not describe specific individual pilot projects.

No more than 10 percent of the total NIH CTSA award funds may be allocated for the Translational Pilot Program, thus it is expected that applicants will not propose a budget for the Translational Pilot Program greater than 10 percent of the proposed total costs.

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The FOA asks for a Program Income System implementation plan. Is there information on the NIH Policy for Program Income that might be helpful as applicants develop a plan?

NCATS asks CTSA sites to develop a phased plan for appropriate implementation of a Program Income System. Information about management of Program Income can be found in the NIH Grants Policy Statement. NCATS encourages applicants to work with their Office of Sponsored Research as they develop plans for implementing a Program Income System.

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Should the Program Income System plan include all provided resources and services?

The application must include a plan for phase-in of a Program Income System by the end of the first year. As stated in the FOA, this plan includes “a method of allocating usage of Resources and Services and the cost for their provision from the CTSA budget.” It is expected that all resources and services will be included in the Program Income System plan. The applicant’s plan should clearly state when the use of a resource or services will generate program income from users and when it will not. Whether program income is generated from a specific use of a resources or services, the costs associated with use of a resource and services by specific projects or investigators must be clear to all users. This will permit the CTSA to 1) track the use and cost of resources or services provided to specific users or projects, 2) generate program income from users as specified in their plan, and 3) re-budget the generated program income (may require prior NIH approval) to establish new resources and services or expand existing resources and services.

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New (Dec. 2012)
Should a PHS 398 “Resources” page be included in the application? If so, what should be included on this page?

A “Resources” section may be included in applications per the PHS 398 instructions. However, this PHS 398 section is for describing the resources available at the applicant and partner institutions generally. This section should not be used to circumvent the Research Plan page limits specific for this FOA. The Research Plan should include the specific information requested in the FOA in the format outlined in Section IV.2 Content and Form of Application Submission – Specific Instructions. Thus, description of the resources and services to be provided by the CTSA program should be described in the Clinical and Translational Resources and Services section of the Research Plan with the information requested specific for this FOA in this section.

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Many of the applicants for the current FOA will have a funded CTSA grant. Will the previous summary statement for these applications be made available to reviewers?

For this FOA, all submitted applications will be considered new. Therefore, previous summary statements will not be provided to the reviewers.

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Please clarify why Human Subjects Research; Inclusion of Women, Minorities, and Children; Vertebrate Animal Research; and Biohazards are review criteria for the Overall application and review of each Section.

Although no specific research projects are to be included in the applications in response to this FOA, plans must be presented for how applicants will address issues related to protection of human subjects; inclusion of women, minorities and children; vertebrate animal care and use; and potential biohazards research as relevant to each section. The reviewers will evaluate these areas in consideration of the overall application and the review of each section. Although these sections are not page-limited, do NOT circumvent the page limits by including information that belongs in other sections.

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Are page limits specified in the FOA tied to the amount of funds being requested? Are page limits different for those institutions that already have a CTSA?

The page limits specified in the FOA are the same for all institutions, regardless of the amount of funds being requested, and regardless of whether or not the applicant institution already has a CTSA.

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May I submit supplemental tables, graphs, figures, drawings and charts that do not count against sectional page limits? What about appendices?

In this FOA, no additional pages outside of the page limits for each section are allowed for tables, graphs, drawings and charts. If an applicant chooses to include such items, they must be within the page limit for a given section. No appendices are allowed in response to the FOA. Applicants are encouraged to be clear, concise and focused in describing their plans.

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New (Dec. 2012)
Will color figures be provided to reviewers?

The paper applications received at the NIH are scanned to produce black and white PDF documents. It is these PDF documents that are sent to reviewers electronically, except in the rare instance when a reviewer requests a hard copy. In that case, NIH prints the scanned black and white PDF document for the reviewer.

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What tables must be included in the Education Section?

No tables are required in the Education Section. Applicants may include tables, charts or graphs within the page limits allowed. The Education Section has specific page limits for each part: A. Overview (Education part of U) description is limited to 12 pages; B. Mentored Career Development Program (KL2) description is limited to 12 pages; and the optional C. Predoctoral and Postdoctoral Research Training Program (TL1) is limited to 12 pages. The Specific aims for the entire Education Section are limited to one page. The descriptions of each part cannot be combined or share pages. “Left over” pages cannot be used in other parts.

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New (Dec. 2012)
Where can I find the Kirschstein-National Research Service Award (NRSA) Substitute Form Pages?

The Kirschstein-NRSA Substitute Form Pages can be found at the links below:

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What biosketches should be included in the application?

Biosketches should be included only for professional staff named in the application and who significantly contribute in substantive and measurable ways to the program. Biosketches should not be included for individuals who are not named in the application or who do not have a significant role in the program.

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New (Dec. 2012)
Can biosketches of mentors be included in the application?

In response to this FOA, biosketches of up to 30 mentors (if you elect to include them) would be included in the "Other Biographical Sketches" section (see Form Page 3). It will be important for the applicant to describe in the "Personal Statement" section of the biosketch "why their experience and qualifications make them particularly well-suited for their role (e.g., mentor) in the project."

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Progress Report Publications are not mentioned in this FOA. Do applications in response to this FOA need such a list?

No. Applications submitted in response to this FOA should not include a Progress Report Publication List.

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Should references be included after each Section or in a single section for the entire application?

References are outside of the page limits and should be in a single References Cited section. It is expected that the Reference Cited section of applications in response to this FOA will be succinct and limited. The References Cited section should not include publication lists. As noted in the above FAQ, No Progress Publication lists are to be included in the application.

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New (Dec. 2012)
Can applicants cite websites as references?

According to the PHS 398 instructions, unless otherwise specified in a solicitation, Internet website addresses (URLs) may not be used to provide information necessary to the review because reviewers are not obligated to view Internet sites. Moreover, reviewers will be cautioned that they should not directly access an Internet site (except to review publications cited in the Biographical Sketch) as it could compromise their anonymity.

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To be responsive to this FOA, must institutions that are strong in early translational research and academic clinical studies support researchers who conduct community and/or health policy research?

A vision and strategic plan for providing an integrated home for translational research does not require having equal strengths in the entire spectrum of translational research. Each applicant should provide the breadth of resources and services appropriate for NIH-supported researchers at their partner institutions.

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With a limited budget, the types and number of resources and services proposed in the Resources and Services Section may be constrained. Do applicants need to address the entire spectrum of translational research?

Applicants must carefully consider the resources and services that they will select to provide with the available funds. The application should describe the process for this selection, the process for assessing the utility of those services, and how changes in resources and services will be decided. Additionally, with the development of a well-designed and well-managed Program Income System, the opportunity may exist in subsequent years — with NCATS approval — for shifting funds to support new and innovative resources and services.

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CTSA RFA-TR-12-006 Information

Currently, NCATS is soliciting applications for institutional Clinical and Translational Science Awards (CTSA). Learn more about RFA-TR-12-006.


Technical Assistance Webinar

NCATS held an institutional CTSA technical assistance webinar on Monday, July 23, 2012. Download the slides from this event. A recording of the webinar is not available.