Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 1. Overview Information
Part 2. Full Text of the Announcement

Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Translating biomedical discoveries into clinical applications is essential to improving human health. It is also a complex process with high costs and substantial failure rates. These failures can result in delays of years or decades before improved patient outcomes result from discoveries in biomedical research. The Clinical and Translational Science Award (CTSA) hubs promote advances in translational research and training at participating medical research institutions. The Collaborative Innovation Award, Clinical and Translational Science Award (CTSA) Program will enable innovative collaborations among CTSA hubs to overcome system-wide barriers to translational effectiveness.

The scientific and operational issues which underlie most translational inefficiency are not specific to a particular disease, discipline, institution, or geographic locale. Rather, they are systematic issues, which require systematic and generalizable solutions. Further, every stage of the translational process, from target validation through intervention development to public health benefit assessment, is currently fraught with ineffectiveness and in need of bold, innovative new solutions. There is therefore a corresponding need for bold and innovative new experimental approaches to identifying such solutions. NCATS' catalysis of the development, demonstration, and dissemination of innovations across the spectrum of translational science will advance its mission to transform the effectiveness of translation of discoveries from the laboratory, clinic, and community into tangible benefits to human health.

This program is one of several sequential steps being taken by NCATS to evolve the CTSA program to augment its ability to, as suggested by a recent Institute of Medicine program report (http://www.iom.edu/Reports/2013/The-CTSA-Program-at-NIH-Opportunities-for-Advancing-Clinical-and-Translational-Research.aspx), enhance the transit of therapeutics, diagnostics, and preventive interventions along the developmental pipeline; disseminate innovative translational research methods and best practices; and provide leadership in informatics standards and policy development to promote shared resources .

Individual CTSA hubs, and more recently groups of hubs, have developed and demonstrated the utility of innovations that improve the efficiency and effectiveness of many aspects of translational research and training. The diversity of CTSA hubs, and their multiplicity nationwide, suggests that fostering cross-CTSA innovation development and implementation could transform the nation's translational effectiveness in unprecedented ways. This program therefore seeks to encourage all CTSA hubs to collaboratively conceptualize, develop, and implement multi-site innovative experimental approaches that overcome translational barriers in science, operations, and training.

We expect that, collectively, the projects funded under this program will have a transformative impact on the nation's translational science enterprise.

This FOA encourages pre-applications for innovative collaborative investigations (involving three or more CTSA sites) into improvements of the methods of translational research, at any step in the translational spectrum (T1-T4). It is anticipated that the combined effort of three or more CTSA hubs in flexible networks will substantially enhance the effectiveness of the CTSA consortium to address high priority translational research questions. The program therefore aim to support innovative and collaborative experimental translational research projects carried out in the CTSA consortium that have the following characteristics:

First, such projects should develop a new technology, method, or approach that addresses a general roadblock in science and/or operations that limits the efficiency and effectiveness of translation. As defined at NCATS, translation is the process of turning observations in the laboratory, clinic, and community into interventions that improve the health of individuals and the public - from diagnostics and therapeutics to medical procedures and behavioral changes. This FOA also supports innovative approaches to training or community/patient engagement that are focused on improving translation.

Second, such projects should demonstrate in one or more use cases whether the tool, method, or approach is effective in accelerating translation, utilizing clear and meaningful metrics and outcomes, when implemented across multiple CTSA hubs.

Third, such projects should advance collaboration, building on existing strengths and resources of individual CTSA hubs. Investigators who are not affiliated with a CTSA hub, but wish to bring an innovative project to the CTSA consortium, can participate in collaboration with a CTSA investigator. Whenever possible, projects should include partnerships between CTSA hubs and external stakeholders such as industry or patient organizations. This is desirable so that the partners can mutually leverage resources, assure meaningful intervention approaches, and increase the likelihood of successful hand-off to the private sector when appropriate.

Fourth, what constitutes success of the proposed project can be defined and measured.

Some examples of such opportunities include but are not limited to:

• Development and implementation of innovative community engagement methods and technologies that demonstrably increase the efficiency and effectiveness of intervention development and deployment, and measurement of their effects on improving health outcomes. Community engagement should be defined broadly to include local and distributed, physical and virtual communities. Research aimed at engaging minority, vulnerable, or other understudied populations in translational research is one area of particular interest.
• Improving the consent process, for example simplifying and reducing the length of the consent forms without sacrificing content; ensuring that the consent form is commensurate with potential participants needs and is culturally sensitive; making the consent process more user-friendly through the use of visual aids or recorded video; in multi-site research, providing similar information across investigators and sites.
• Educating and training the translational research workforce through collaborative initiatives across multiple CTSA hubs that leverage local strengths, using innovative features such as shared, online resources, individualized training with focus on competencies rather than degrees, training in multi-disciplinary team science, regulatory science, entrepreneurship and experiential learning experiences, for example through externships in industry, regulatory agencies, or nonprofit organizations.
• Developing mechanisms for CTSA-catalyzed networks to identify and fast-track particularly promising translational research projects, thereby reducing the time required for intervention development or demonstration of unfeasibility.
• Adapting technology and methodology that are shown to be successful in other domains to address challenges in clinical and translational research.
• Fostering innovative multi-disciplinary collaborations that bring together new types of teams to solve particular clinical and translational research problems.
• Innovative clinical research studies or trials that use mobile technology and web- or phone- based communication to obtain information such as patient reported outcomes and remote biological measures.
• Innovative clinical research designs, such as adaptive designs, serial n of 1 design, or other approaches to small populations, which could overcome some of the challenges in evaluating interventions.
• Innovative approaches to the implementation of precision medicine
• Innovative methodologies that address translational research roadblocks specific to pediatric, geriatric, or other populations throughout the lifespan - e.g., new ways to develop outcome measures or validate biomarkers relevant to those populations, and enhancing lifestage-specific investigator training.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Higher Education Institutions

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)
• Eligible Agencies of the Federal Government
• U.S. Territory or Possession

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

• Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
• System for Award Management (SAM) (formerly CCR) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
• eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.
Applications must involve investigators from at least 3 CTSA hubs. Each hub must have an active CTSA Award (U54) as of the due date of the application.
The PD/PI, or contact PD/PI in applications using the multiple PD/PI option, must be employed by an Institution with an active CTSA Award (U54). For the Collaborative Innovation Awards (PAR-15-173 and PAR-15-172) the PD/PI, or contact PD/PI in applications using the multiple PD/PI option, must be employed by an Institution with an active CTSA Award (U54), or by a partner institution as identified in the application for the active CTSA award.

Investigators who are not employed by an institution with an active CTSA Award or partner Institution but who wish to bring an innovative project to the CTSA consortium, can co-direct a project in partnership with a CTSA investigator using the multiple PD/PI option.

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101).

Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants.gov.

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

• Descriptive title of proposed activity
• Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity

The letter of intent should be sent to:

Philip J. Brooks, PhD.
Telephone: 301-443-0513
Fax: 301-480-3661
Email: CTSAInnovationFOAquestions@mail.nih.gov

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed, with the following exceptions or additional requirements:

• For this specific FOA, the Research Strategy section is limited to 6 pages.

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

All instructions in the SF424 (R&R) Application Guide must be followed, along with the following additional instructions.

Type of Submission: Select "Pre-application".

Total Federal Funds Requested: Enter "0".

Total Federal and Non-Federal Funds: Enter "0".

Estimated Program Income: Enter "0".

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed, along with the following additional instructions.

Are Human Subjects Involved: Answer "No".

Are Vertebrate Animals Used: Answer "No".

All instructions in the SF424 (R&R) Application Guide must be followed. Key personnel at each of the three or more CTSA sites should be identified, and biosketches included.

Not Applicable

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

Specific Aims: Briefly state the specific aims of the project, indicating how the project will contribute to advancing translational science.

Research Strategy: This section should include:

A statement of the problem being studied, and its significance to translational science

A description of and rationale for the proposed innovation. If successful, how would the proposed innovation transform some aspect of translational science ?

A description of the overall strategy and methodology used to accomplish the goals and specific aims of the project. The description should address the following points, using separate headers for each of the subheading Collaboration, Innovation, Translation, Partnership, Barriers, and Defining Success.

Collaboration: Applicants should describe how their project will build on the existing strength of the CTSA consortium, and involve at least three CTSA hubs who collaborate on a translational research project. Applicants should describe their plans and timeframe for how multiple CTSA hubs will participate in this research, identifying those responsible for various efforts, declared milestones, metrics, individual responsibilities, and plans for dissemination of research results.

Innovation: Applicants should explain how their project is innovative. When no available tool or method is suitable, the project may include the development of a novel tool or method. When suitable tools or methods exist, applicants should describe their choice of approach, and how the existing tools are used in an innovative manner to advance translation. Applicants should discuss how the project might open a new avenue of translational research, or might be a systematic improvement over the current methods used in translational research. They should note whether the proposed research is an extension of active area of research or a new project for the investigators.

Translation: As applicable to the specific project, applicants should describe:

how the proposed collaborative project, if successful, will impact human health or will result in an intermediate outcome linked to health impact; how the innovation proposed in research methods will lead to improvements in the identification, testing, and dissemination of potentially useful means of prevention, diagnosis, and treatment of human disease; or how innovation in the training of the next generation of translational scientists will impact the field of translational science.

Applicants should specifically describe how their project can be generalized to other settings

Partnership: There should be a description of any partnerships, such as other clinical sites, those with patient organizations, or partners in the private sector in the area of diagnostics, therapeutics or preventive measures. Applicants should discuss necessary engagement with relevant communities such as the public at large, with relevant patient communities, or with underserved communities. This engagement should occur in all phases of the project and include pre-study discussions, ongoing involvement, updates, and ultimately dissemination of results.

Barriers: Applicants should identify any perceived clinical or scientific barriers or ethical issues and solutions proposed.

Defining success: Applicants should define success for the proposed project and how it can be measured

For projects proposing to use Human Subjects, include a description of how the project will be approved and monitored by an Institutional Review Board (IRB).

Letters of Support: Letters of support are NOT required for the X02 pre-application.

Resource Sharing Plan: Briefly describe a plan for dissemination of the results, regardless of the outcome, to the CTSA Program and broader translational science community. Don t use this section to expand the information about facilities, core managers, existing resources, or other topics that are covered in other sections.

Appendix: Not Applicable

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date. If a Changed/Corrected application is submitted after the deadline, the application will be considered late.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

This initiative is not subject to intergovernmental review.

No awards will be made in response to this X02 FOA.

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues.

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Notification of the NCATS Referral Office is no longer requested.

Not Applicable

Important Update: See NOT-OD-16-006 for updated review language for applications for due dates on or after January 25, 2016.

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

This FOA is intended to enable innovative, experimental approaches to overcome system-wide barriers to translation via collaborations among investigators from three of more CTSA hubs.

Reviewers will provide an overall impact evaluation to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria (as applicable for the project proposed).

Does the application entail a strong and meaningful collaboration among at least three CTSA hubs? Does each of the collaborators make a significant contribution to the overall project ? Does the project build on the existing strength and resources of the CTSA program?

Does the proposed innovation have potential to transform translational research? Does the proposed project create an innovative new approach, method, or tool, or describe the innovative application of one or more existing tools? Does the application describe an innovative project that can be adapted to translational research challenges across multiple CTSA hubs?

Does the proposed project answer an important translational science question, or does it address a gap in translational science? Will the results of the project be generalizable to other settings?

Do the applicants leverage partnerships? Do the partners play a substantial role, and is there evidence of commitment and support? Are there plans for engaging partners in next steps, or is there a hand-off plan?

Have the applicants considered and addressed potential barriers to success, and discussed contingency plans and described alternative approaches?

Have the applicants presented a realistic plan to measure the success of the proposed project?

Have the applicants presented a realistic plan to disseminate the results of the project throughout the CTSA consortium and broader translational research community?

If the project proposes clinical research involving Human Subjects, is the IRB process streamlined (e.g., use of single or central IRB or IRB of record)

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

For clinical studies, the plan for use of a single IRB or an IRB of record will be evaluated..

Not Applicable

Not Applicable

Not Applicable

Not Applicable

Not Applicable

Not Applicable

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

Not Applicable

Not Applicable

Not Applicable

Not Applicable

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by NCATS, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

• Will receive a written critique.

The following will be considered in notifying applicants of the opportunity to submit a U01 application:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• The potential for the proposed innovation to significantly impact the conduct of translational science, relative to currently available approaches..

Not Applicable

Not Applicable

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Cooperative Agreement Terms and Conditions of Award

Not Applicable

Not Applicable

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
Finding Help Online: http://grants.nih.gov/support/index.html
Email: commons@od.nih.gov

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact CenterTelephone: 800-518-4726
Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-710-0267

Philip J. Brooks, Ph.D.
National Center for Advancing Translational Sciences (NCATS)
Telephone: 301-443-0513
Email: pjbrooks@mail.nih.gov

Mohan Viswanathan, Ph.D.
National Center for Advancing Translational Sciences (NCATS)
Telephone: 301-312-3745
Email: mv10f@nih.gov

Leslie Le
National Center for Advancing Translational Sciences (NCATS)
Telephone: 301-435-0856
Email: LeLeslie@mail.nih.gov

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

No awards will be made through this X02 announcement.