It is critical that applicants follow the instructions in the Research Instructions for 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

This funding opportunity announcement (FOA) invites applications for a Coordination Center (CC) that will support activities of the Clinical Translational Science Award (CTSA) Program. The CTSA Program supports high quality translational and clinical research locally, regionally and nationally and fosters innovation in research methods, informatics, training, and career development. The CTSA Program is evolving into an innovative national consortium of medical research institutions that comprises hubs working together to support translational science and improve the research process in order to get more treatments to more patients more quickly. It is expected that the CTSA Program CC will facilitate collaboration and consortium activities. Specifically, the CTSA Program CC will be responsible for providing an environment of excellence, developing and applying innovative approaches to collection, analysis, use and sharing of various types of data for strategic management of the CTSA Program, and creating an effective collaboration, coordination, and communication infrastructure to support scientific, training, governance, workgroup, and other types of consortium activities within the CTSA Program.

This FOA solicits applications from investigators with expertise in providing an environment of excellence; developing and applying innovative approaches to evaluate and increase the impact of research consortiums; promoting team science; enhancing collaboration, coordination, communication and messaging across a large consortium; and managing large, collaborative research consortiums. This FOA will be administered as a cooperative agreement and therefore substantial programmatic involvement of Program Staff and the awarded CC is anticipated.

Translating biomedical discoveries into clinical applications that improve human health is a complex process with high costs and substantial failure rates. This can result in a delay of years or decades before discoveries in biomedical research result in health benefits for patients and communities. Recognizing the need to improve translation, the National Institutes of Health (NIH) established the CTSA Program in 2006. Within the context of the CTSA Program, 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 interventions. In 2011, the CTSA Program became part of the National Center for Advancing Translational Sciences (NCATS). The mission of NCATS is to catalyze the generation of innovative methods and technologies that will enhance the development, testing and implementation of diagnostics and therapeutics across a wide range of human diseases and conditions. To accomplish this, NCATS promotes excellence in translational science a relatively new field of inquiry focused on understanding and improving the scientific and operational principles underlying each step of the translational process. To accelerate this process, NCATS further promotes innovation in translational research to develop, demonstrate, and disseminate advances across the translational science spectrum.

In 2013, at the suggestion of Congress, the Institute of Medicine (IOM) generated a report on "The CTSA Program at NIH: Opportunities for Advancing Clinical and Translational Research - Institute of Medicine". The report recommended the program could greatly increase its impact if the largely independent CTSA hubs were to increase collaborations and evolve into a national network to enhance the transit of therapeutic, diagnostic, 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.

With feedback from key stakeholders, NCATS developed the following goals for the CTSA program:

1. Workforce Development - The translational science workforce has the skills and knowledge necessary to advance translation of discoveries.

2. Collaboration/Engagement - Stakeholders are engaged in collaborations to advance translation.

3. Integration - Translational science is integrated across its multiple phases and disciplines within complex or understudied populations and across the individual lifespan.

4. Methods/Processes - The scientific study of the process of conducting translational science itself enables significant advances in translation.

5. Informatics Innovative informatics solutions are used to advance translational research, train the CTSA workforce, disseminate best practices, engage communities of the stakeholders, and integrate clinical and basic research data.

NCATS continues to build on the strong foundation of the CTSA Program to tackle system-wide scientific and operational problems to make the clinical and translational research enterprise more efficient and impactful (e.g. finding solutions in moving findings from preclinical into first in human studies more effectively; improving speed and quality of clinical trials, etc.). Providing opportunities for collaborative activities at the regional and national level and building infrastructure and systems to leverage the strengths of individual CTSA Program hubs is an essential component of creating a national network for biomedical translational research.

This FOA will build on the existing efforts of the CTSA Program Coordinating Center (C4, established in November 2011). Since its inception, the coordinating center has developed and implemented practices to standardize and coordinate translational research activities among the CTSA Program hubs (e.g., project and meeting support, listservs, etc.). The coordinating center also ensured the development and dissemination of best practices, facilitated the uptake of available tools and resources, and promoted collaboration, in part, through the website, CTSAcentral.org.

The overall programmatic goal of this CC is to facilitate collaboration within the national consortium and beyond. This national consortium will provide excellence and innovation in translational research, training, methods, tools, processes, and best practices; and provide leadership in informatics standards and the development of policies to promote shared resources.

The CC will be expected to work closely with the CTSA Program hubs, Trial Innovation Centers (TICS) (RFA-TR-15-002), Recruitment Innovation Centers (RICS) (RFA-TR-15-004), other innovative collaborative programs (for example, PAR-15-172), external partners, stakeholders, NCATS, and NIH staff in order to accomplish this goal.

The CC will create an environment of excellence and develop, test, and implement innovative approaches to: 1) collect and manage data to gauge and improve the impact of CTSA Program Hubs and the evolving CTSA Program Consortium; 2) strengthen collaboration and team science; and 3) foster effective communication to support internal CTSA Program activities and engage key external stakeholders.

The scope of activities to be undertaken by the CTSA Program CC may include:

1) Collect and manage data to gauge and improve the impact of the CTSA Program hubs and the evolving CTSA Program Consortium, including:

• Demonstrate the capacity to provide appropriate and capable leadership for collecting, analyzing, and displaying data related to the strategic management of the CTSA Program through the use of Common Metrics.
• Develop a transparent system to collect, analyze, and visualize common metric data from the CTSA Program hubs. A successful application should include plans to develop, disseminate, and implement metrics and will be contingent on being able to use the Results-Based Accountability framework (http://raguide.org/).
• Contribute to establishing harmonized common metric data standards.
• Provide training and education of personnel at the CTSA Program hubs to ensure accurate reporting and quality control of the metrics.
• Provide accurate reporting of common metrics to: 1) be useful to and used by the CTSA Program Directors/Principal Investigators and NCATS Staff for strategic management of the CTSA Program hubs and the CTSA Program Consortium; 2) focus strategic management on maximizing the impact of the CTSA Program; and 3) facilitate collaboration and shared accountability for maximizing the impact of the CTSA Program.
• Provide additional scientific programmatic analysis and reports required for oversight and scientific strategic management of the CTSA Program.

2) Strengthen collaboration and team science, including:

• Support collaboration efforts in advancing the five strategic goals of the CTSA Program. For planning purposes the CC will be responsible for the operational and logistical support of the activities and meetings of the CTSA Program Steering Committee, CTSA Program Pods (a Pod is a structure for communication between one Steering Committee member and 5-6 CTSA Program hubs), five Domain Task Forces (DTFs) as well as up to the twenty-five working groups under the DTFs, one annual in-person meeting for each of the five DTFs, and meetings with external stakeholders.
• Identify translational science research gaps and dissemination of information on translational science successes.
• Disseminate research resources and other products by managing the assessment of the value of these products and educate and train people in the use and application of these products.
• Disseminate high-quality education and training resources and materials (e.g. Massive Open Online Content or MOOCs), including workshops, externship offerings, conferences and courses.
• Respond appropriately to changing work needs, CTSA Program prioritization and re-prioritization, and changes in staffing.

3) Foster effective communication to support internal CTSA Program activities and engage key external stakeholders, including:

• Support communication among NCATS, CTSA Program Investigators, and external stakeholders. For planning purposes the CC will be responsible for two annual in-person meetings of the CTSA Program Steering Committee, two in-person CTSA Program meetings per year (of which one will be held in conjunction with the annual Association for Clinical and Translational Science meeting held in Washington, D.C.), and up to four other in-person meetings as needed in coordination with NCATS.
• Provide a secure internet-based infrastructure to support communications and document sharing among the CTSA Program hubs.
• Provide a secure method for transmitting raw data files to and from the CTSA Program hubs.
• Maintain up-to-date versions of the policies and procedures developed by the Steering Committee and NCATS Program Staff and make these documents readily available.
• Facilitate communication with other key stakeholders that may include, but are not limited to: other NIH institutes, governmental agencies (e.g. Food and Drug Administration), research organizations (e.g. PCORI), research and disease foundations, the biotechnology or pharmaceutical industry, the research community, patients and families, and patient advocacy groups.
• Develop and maintain a CTSA Program public plain-language website that may include:

1) information and statistics about the CTSA Program (including Common Metrics);

2) best practices for clinical and translational science, tools, methods, team science, training, multi-site clinical trials, and other innovations;

3) sharing, disseminating, and advertising available resources; and

4) CTSA Program innovations (e.g. creation of a Translational Science Grand Rounds webinar series to promote translational science). For example, these activities might include the NCATS Streamlined, Multisite, Accelerated Resources for Trials (SMART), such as the IRB Reliance Platform tools, and standard operating procedures and other resources to be developed by the Trial Innovation Centers and the Recruitment Innovation Centers.

Non-Responsive Applications

Applications that include the following will be considered non-responsive and will not be reviewed:

• Applications that do not propose to address all three areas of the research objectives and scope.

See Section VIII. Other Information for award authorities and regulations.

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 not 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.

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).

Buttons to access the online ASSIST system or to download application forms are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

It is critical that applicants follow the instructions in the Research Instructions for 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:

Mohan Viswanathan, Ph.D.
Telephone: 301-312-3745
Fax: 301-480-3660
Email: [email protected]

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

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.

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

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

Facilities and Other Resources: Indicate how the applicant organization is concentrating on its core competencies in order to maximize its chances of success. Describe established alliances/collaborative partnerships where they are appropriate or needed to facilitate attainment of the research goals.

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

Biographical Sketch: Describe experience with fulfilling the mission of the CTSA Program or a comparable program, including the proper scientific background, experience with the administrative management of large research projects or consortium activities, experience with database and web portal design and curation, dissemination of various resources and information to stakeholders and to the broader scientific community, or the development and implementation of metrics for large initiatives.

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

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

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:

Research Strategy

Applicants must address all three areas within the research objectives and scope of the award.

Specifically, applicants should describe how they propose to:

1) Collect and manage data to gauge and improve the synergistic impact and performance of the CTSA Program hubs and the evolving CTSA Program Consortium, including:

• Demonstrate the capacity to provide appropriate and capable leadership for collecting, analyzing, and displaying data related to the strategic management of the CTSA Program through the use of Common Metrics.
• Develop a transparent system to collect, analyze, and visualize common metric data from the CTSA Program hubs. A successful application should include plans to develop, disseminate, and implement metrics and will be contingent on being able to use the Results-Based Accountability framework (http://raguide.org/).
• Contribute to establishing harmonized common metric data standards.
• Provide training and education of personnel at the CTSA Program hubs to ensure accurate reporting and quality control of the metrics.
• Provide accurate reporting of common metrics to: 1) be useful to and used by the CTSA Program Directors/Principal Investigators and NCATS Staff for strategic management of the CTSA Program hubs and the CTSA Program Consortium; 2) focus strategic management on maximizing the impact of the CTSA Program; and 3) facilitate collaboration and shared accountability for maximizing the impact of the CTSA Program.
• Provide additional scientific programmatic analysis and reports required for oversight and scientific strategic management of the CTSA Program.

2) Strengthen collaboration and team science through establishment of innovative team structure/interactions, strategies and tools, including:

• Support collaboration efforts in advancing the five strategic goals of the CTSA Program. For planning purposes the CC will be responsible for the operational and logistical support of the activities and meetings of the CTSA Program Steering Committee, CTSA Program Pods (a Pod is a structure for communication between one Steering Committee member and 5-6 CTSA Program hubs), five Domain Task Forces (DTFs) as well as up to the twenty-five working groups under the DTFs, one annual in-person meeting for each of the five DTFs, and meetings with external stakeholders.
• Identify translational science research gaps and dissemination of information on translational science successes.
• Disseminate research resources and other products by managing the assessment of the value of these products and educate and train people in the use and application of these products.
• Disseminate high-quality education and training resources and materials (e.g. Massive Open Online Content or MOOCs), including workshops, externship offerings, conferences and courses.
• Respond appropriately to changing work needs, CTSA Program prioritization and re-prioritization, and changes in staffing.

3) Foster innovative and effective communication and messaging, including asynchronous communication methods, to support internal CTSA Program activities and engage key external stakeholders, including:

• Support communication among NCATS, CTSA Program Investigators, and external stakeholders. For planning purposes the CC will be responsible for two annual in-person meetings of the CTSA Program Steering Committee, two in-person CTSA Program meetings per year (of which one will be held in conjunction with the annual Association for Clinical and Translational Science meeting held in Washington, D.C.), and up to four other in-person meetings as needed in coordination with NCATS.
• Provide a secure internet-based infrastructure to support communications and document sharing among the CTSA Program hubs.
• Provide a secure method for transmitting raw data files to and from the CTSA Program hubs.
• Maintain up-to-date versions of the policies and procedures developed by the Steering Committee and NCATS Program Staff and make these documents readily available.
• Facilitate communication with other key stakeholders that may include, but are not limited to: other NIH institutes, governmental agencies (e.g. Food and Drug Administration), research organizations (e.g. PCORI), research and disease foundations, the biotechnology or pharmaceutical industry, the research community, patients and families, and patient advocacy groups.
• Develop and maintain a CTSA Program public plain-language website that may include:

1) information and statistics about the CTSA Program (including Common Metrics);

2) best practices for clinical and translational science, tools, methods, team science, training, multi-site clinical trials, and other innovations;

3) sharing, disseminating, and advertising available resources; and

4) CTSA Program innovations (e.g. creation of a Translational Science Grand Rounds webinar series to promote translational science). For example, these activities might include the NCATS Streamlined, Multisite, Accelerated Resources for Trials (SMART), such as the IRB Reliance Platform tools, and standard operating procedures and other resources to be developed by the Trial Innovation Centers and the Recruitment Innovation Centers.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide..

• All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

When conducting clinical research, follow all instructions for completing PHS Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

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

See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

Part I. Overview Information contains information about Key Dates and times. 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. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

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 and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

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.

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

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. For assistance with application submission, contact the Application Submission Contacts in Section VII.

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.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Applicants are required to follow our Post Submission Application Materials policy.

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.

Reviewers will provide an overall impact score 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 and additional review criteria (as applicable for the project proposed).

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Does the proposed Center address the needs of the CTSA Program that it will coordinate? Is the scope of activities proposed for the Center appropriate to meet those needs? Will successful completion of the aims bring unique advantages or capabilities to the CTSA Program?

Specific to this FOA: If the proposed CTSA CC is fully successful in carrying out its plan and mission, will it 1) have a synergistic effect on the overall performance of the CTSA Program, 2) enhance collaborations within the CTSA Program and with external stakeholders, 3) effectively conduct scientific programmatic analyses and develop and disseminate meaningful and feasible common metrics for the strategic management at the hub and across the CTSA Program, and 4) effectively disseminate research resources and other products to stakeholders and the broader scientific community?

Are the PD(s)/PI(s) and other personnel well suited to their roles in the Center? Do they have appropriate experience and training, and have they demonstrated experience and an ongoing record of accomplishments in coordinating and administering large, collaborative networks, implementing common metrics for the evaluation of large and complex programs, coordinating data and analyses, and communicating and messaging to stakeholders? Do the investigators demonstrate significant experience with these tasks? Does the applicant have experience overseeing selection and management of subawards, if needed?

Specific to this FOA: Does the project team have appropriate experience with fulfilling the mission of the CTSA Program or a comparable program, including the proper scientific background, experience with the administrative management of large research projects or consortium activities, experience with database and web portal design and curation, dissemination of various resources and information to stakeholders and to the broader scientific community, and the development and implementation of metrics for large initiatives?

Does the application propose novel management strategies in coordinating the CTSA Program? Are the concepts, strategies, or instrumentation novel to one type of research program or applicable in a broad sense? Is a refinement, improvement, or new application of management strategies proposed?

Specific to this FOA: How innovative are the proposed team structure/interactions, strategies and tools compared to standard team science management and data/reagent/technology sharing approaches? Are there innovative types of asynchronous communication and messaging described?

Are the overall strategy, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of the CTSA Program? Will the investigators promote strategies to ensure a robust and unbiased scientific approach across the CTSA Program, as appropriate for the work proposed? Are an appropriate plan for work-flow and a well-established timeline proposed?

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of children, justified in terms of the scientific goals and research strategy proposed?

Will the institutional environment in which the Center will operate contribute to the probability of success in facilitating the CTSA Program? Will the Center benefit from unique features of the institutional environment, infrastructure, or personnel? Are resources available within the scientific environment to support electronic information handling?

Specific to this FOA: Is the applicant organization concentrating on its core competencies in order to maximize its chances of success? Has the applicant established alliances/collaborative partnerships where they are appropriate or needed to facilitate attainment of the research goals?

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 research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

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

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3) Genomic Data Sharing Plan (GDS).

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

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:

• May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
• Will receive a written critique.

Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the appropriate National Advisory Council or Board. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.

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.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.

For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and http://www.hhs.gov/ocr/civilrights/understanding/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Part 75, and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

The PD(s)/PI(s) will have the primary responsibility for:

• Overall function of the CTSA Program CC. This includes responsibility for collecting and managing data to gauge and improve the impact of the CTSA Program hubs and the evolving CTSA Program Consortium, strengthening collaboration and team science, and fostering effective communication to support internal CTSA program activities and engaging key external stakeholders.
• Providing overall scientific and administrative leadership for the project activities.
• Developing research objectives and approaches, and prioritizing project activities.
• Overseeing all aspects of the organization and execution of the activities and projects as outlined in the application and approved by NCATS after peer review.
• Providing operational and logistical support of the activities and meetings of the CTSA Program and Steering Committee, CTSA Program Pods, and 5 Domain Task Forces (DTFs) as well as up to the 25 working groups under the DTFs, one annual in-person meeting for each of the 5 DTFs, and meetings with external stakeholders.
• Providing support for communication among NCATS, CTSA Program Investigators, and external stakeholders that includes supporting two annual in-person meetings of the CTSA Program Steering Committee, two in-person CTSA Program meetings per year (of which one will be held in conjunction with the annual Association for Clinical and Translational Science meeting held in Washington, D.C.), and up to four other in-person meetings as needed in coordination with NCATS.
• Collecting, analyzing, and displaying data related to the strategic management of the CTSA Program through the use of Common Metrics.
• Developing, disseminating, and implementing metrics for the CTSA Program through the use of the Results-Based Accountability framework (http://raguide.org/). Contributing to establishing harmonized common metric data standards. The awardee(s) agree to collaborate on these activities with the Common Metrics Executive Committee.
• Planning, conducting, analyzing, and publishing results, interpretations, and conclusion of relevant project activities; placing all relevant activity and project materials into the public domain. Awardees are expected to publish and publicly disseminate results, data, and other products of the project, concordant with governance policies and protocols. Publications and oral presentations of work performed under this agreement will require appropriate acknowledgment of support by the NCATS/NIH.
• Awardee(s) will agree to accept close coordination, cooperation and participation of NCATS Program Staff in those aspects of scientific and technical management of the project as described under the responsibilities of the NCATS Project Scientist and NCATS Program Official.
• Awardee(s) will agree to the governance of the CTSA Program Consortium.
• Presentation of semi-annual reports to the NCATS CTSA Steering Committee on the CTSA Program CC current and planned activities.
• Obtaining prior written approval of the NCATS Grants Management Specialist in consultation with the NCATS Program Officer for any change in any of the key personnel identified in the Notice of Grant Award.

NIH staff has substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below. An NCATS Project Scientist will have substantial programmatic involvement that is above and beyond the typical stewardship role in other awards, as described below. In addition to the Project Scientist, an NCATS Program Official will be responsible for programmatic stewardship of the award and will be named in the award notice.

The NCATS Project Scientist will:

• Provide substantial scientific and programmatic involvement during the conduct of this activity through technical assistance, advice, and coordination. This involvement is above and beyond the normal stewardship role in awards.
• Participation in the development and prioritization of activities and projects.
• Provide cooperation or coordination with, or assistance to, awardee(s) in performing project activities, (e.g., collecting and managing data to gauge and improve the impact of the CTSA Program hubs and the evolving CTSA Program Consortium, strengthening collaboration and team science, and fostering effective communication to support internal CTSA program activities and engaging key external stakeholders).
• Participate on committees as a voting member or in other functions responsible for helping to guide the course of long-term projects or activities.
• Provide assistance with the selection of contractors or sub-awardees under the assistance award, and in the selection of key project personnel other than principal investigators of projects or sub-projects.
• Coordinate interactions with relevant programs; provide expertise and overall knowledge of NIH-sponsored programs and other projects to facilitate collaboration (e.g. coordinating access to NIH supported research resources, identifying other researchers/resources for the projects).
• Coordinate interactions with relevant groups as necessary (NCATS CTSA Steering Committee, NIH institutes, governmental agencies, research organizations, research and disease foundations, the biotechnology or pharmaceutical industry, and other external stakeholders).
• Providing for an option to halt a project activity if technical performance requirements are not met, if program objectives have already been met, or if program objectives change.
• Participation in the presentation of results, including publications from the project.
• Participation in the development semi-annual reports to the NCATS CTSA Steering Committee on the CTSA Program CC current and planned activities.
• Assess the awardee’s overall participation in and contributions to the CTSA Program Consortium and its support for development and implementation of the project activities described under this award.
• Have no involvement in normal program stewardship.

The NCATS Program Official will:

• Ensure enforcement of general statutory, regulatory, or policy requirements.
• Approve awardee plans prior to award and review of performance after completion.
• Evaluate progress by reviews of technical or fiscal reports, site visits, or external consultants, to determine that performance is consistent with the terms and conditions of the award.
• Provide technical assistance requested by awardees, or unanticipated procedures to correct programmatic or financial deficiencies in awardees' performance.
• Hold scientific/technical discussions with awardees, or undertake actions to facilitate or expedite interactions between awardees, e.g., organizing and holding meetings of investigators.
• The NIH reserves the option to recommend withholding or reducing support from activities that fail to achieve their programmatic goal(s) and/or comply with the Terms and Conditions.

Areas of Joint Responsibility include:

• Collectively awardee(s) and NCATS staff will determine criteria and processes for quality control of information and data to be posted for the research community, consistent with NIH policies and achieving the goals of the program as described in this Funding Opportunity Announcement.
• Participate in recurring meetings (no less than monthly) by teleconference, or more frequently as needed, to discuss priorities, progress, obstacles, solutions and any other related issues and/or activities related to ongoing and planned activities of the CTSA Program CC.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee or comparable body chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.

In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 Award Term and Conditions for Recipient Integrity and Performance Matters.

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)
Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726
Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-710-0267

Erica Rosemond, Ph.D.
National Center for Advancing Translational Sciences (NCATS)
Telephone: 301-594-8927
Email: [email protected]

Carol Lambert, Ph.D.
National Center for Advancing Translational Sciences (NCATS)
Telephone: 301-435-0814
Email:[email protected]

Artisha Eatmon
National Center for Advancing Translational Sciences (NCATS)
Telephone: 301-435-0845
Email: [email protected]

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.

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.