Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Center for Advancing Translational Sciences (NCATS)

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

National Institute of Dental and Craniofacial Research (NIDCR)

National Institute of General Medical Sciences (NIGMS)

National Institute on Minority Health and Health Disparities (NIMHD)

All applications to this funding opportunity announcement should fall within the mission of the Institutes/Centers. The following NIH Offices may co-fund applications assigned to those Institutes/Centers.

Office of Behavioral and Social Sciences Research (OBSSR)

Office of Research on Women's Health (ORWH)

Funding Opportunity Title
Limited Competition: Clinical and Translational Science Award (CTSA) Program: Collaborative and Innovative Acceleration Award (UG3/UH3 Clinical Trial Optional)
Activity Code

UG3/UH3 Exploratory/Developmental Phased Award Cooperative Agreement

Announcement Type
New
Related Notices

NOT-TR-18-025 - National Center for Advancing Translational Sciences (NCATS) Policy for Support of Phase III Clinical Trial Activities for a Rare Disease or Condition

Funding Opportunity Announcement (FOA) Number
PAR-22-167
Companion Funding Opportunity
None
Assistance Listing Number(s)
93.350, 93.859, 93.121, 93.865, 93.307, 93.313, 93.846
Funding Opportunity Purpose

The Clinical and Translational Science Award (CTSA) Program Collaborative and Innovative Acceleration Award (CCIA) supports synergistic activities that accelerate the translational research process through collaboration and innovation. This funding opportunity announcement (FOA) invites applications to develop, demonstrate and disseminate innovative solutions to transform the field of translational science by addressing the inefficiencies that are common across diseases and bringing more interventions to all people more quickly through collaborative science among the CTSA Program hubs, NIH Institutes, Centers, Offices (ICOs), and/or external stakeholders.

Key Dates

Posted Date
May 09, 2022
Open Date (Earliest Submission Date)
June 15, 2022
Letter of Intent Due Date(s)

30 days prior to the application due date

Application Due Dates Review and Award Cycles
New Renewal / Resubmission / Revision (as allowed) AIDS Scientific Merit Review Advisory Council Review Earliest Start Date
July 15, 2022 July 15, 2022 Not Applicable October 2022 January 2023 April 2023
October 17, 2022 October 17, 2022 Not Applicable February 2023 May 2023 July 2023
February 15, 2023 February 15, 2023 Not Applicable June 2023 October 2023 December 2023
June 15, 2023 June 15, 2023 Not Applicable October 2023 January 2024 April 2024
October 17, 2023 October 17, 2023 Not Applicable February 2024 May 2024 July 2024
February 15, 2024 February 15, 2024 Not Applicable June 2024 October 2024 December 2024
June 18, 2024 June 18, 2024 Not Applicable October 2024 January 2025 April 2025
October 17, 2024 October 17, 2024 Not Applicable February 2025 May 2025 July 2025

All applications are due by 5:00 PM local time of applicant organization. 

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

Expiration Date
October 18, 2024
Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from 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.

There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

  1. Use the NIH ASSIST system to prepare, submit and track your application online.
  2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.

  3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.


  4. Table of Contents

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Purpose

The Clinical and Translational Science Award (CTSA) Program Collaborative and Innovative Acceleration Award (CCIA) supports synergistic activities that accelerate the translational research process through collaboration and innovation. This funding opportunity announcement (FOA) invites applications to develop, demonstrate and disseminate innovative solutions to transform the field of translational science by addressing the inefficiencies that are common across diseases and bringing more interventions to all people more quickly through collaborative science among the CTSA Program hubs, NIH Institutes, Centers, Offices (ICOs), and/or external stakeholders.

Background

Translating biomedical discoveries and behavioral observations into clinical applications and public health practice is essential to improving human health. The National Center for Advancing Translational Sciences (NCATS) is transforming translational science by relying on the power of data, new technologies, community and stakeholder engagement, and collaborative science to develop, demonstrate and disseminate innovative solutions that reduce, remove or bypass costly and time-consuming bottlenecks in translational research. NCATS and CTSA Program Consortium’s efforts are intended to complement and empower translational research activities supported by NIH ICOs and/or external stakeholders, including but are not limited to, other US federal government agencies, state and local health departments, tribal nations, US government support organizations, industry, contract research organizations, research institutes, non-profit organizations, foundations, professional associations, patient organizations, small business and entrepreneurs, academic institutions, private sector, and community groups. By emphasizing innovation and collaborative science, NCATS serves as a catalyst to enable all entities in the translational research enterprise to work more efficiently and effectively to bring more interventions to all people more quickly. Interventions are defined broadly to include, but not limited to, approaches, strategies, methodologies, platforms, technologies, tools and instrumentations.

Translation’ is defined by NCATS as 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. ‘Translational research’ is defined by NCATS as the endeavor to traverse a particular step of the translational process for a particular target or disease. ‘Translational science’ is the field of investigation focused on understanding the scientific and operational principles underlying each step of the translational process. Translational research focuses on the specific case of a target or disease, whereas translational science is focused on the general case that applies to any target or disease. Its focus areas are the common causes of inefficiency and failure in translational research projects (for example, incorrect predictions of the toxicity or efficacy of new drugs, lack of data interoperability and ineffective clinical trial recruitment). As these causes are the same across targets, diseases and therapeutic areas, advances in translational science will increase the efficiency and effectiveness of translational research in all therapeutic areas. Like any other science, translational science seeks to elucidate general operative principles in order to transform translation from an empirical, phenomenological process into a predictive science. ‘Translational scientists’ are multi-disciplinary academic and non-academic (e.g., community researchers, patient investigators) researchers that specialize in translation science and possess the skills and fundamental characteristics including domain expert, boundary crosser, team player, process innovator, skilled communicator, systems thinker, and rigorous researcher.

Each research stage across the translational science spectrum, from target validation through intervention development to public health benefit assessment, is currently fraught with inefficiency and in need of bold, new, innovative solutions. Thus, there is a corresponding need for bold, new, innovative 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.

Under NCATS’ strategic goals, the CTSA Program supports a national consortium of medical research institutions / academic health centers and their partners and collaborators, also known as CTSA hubs. The overall purpose of the CTSA program is to deliver scientific and systems change that solve the many outstanding problems limiting the efficiency, effectiveness, and reach of clinical translational research, and thus get more interventions to all people more quickly across the country. The hubs collaborate locally, regionally, and nationally to catalyze innovation in training, research tools and processes. The CTSA hubs strives to address the eight CTSA Program goals:

(1) Advancing clinical and translational science (CTS), that is developing, demonstrating, and disseminating scientific and operational innovations that improve the efficiency and effectiveness of clinical translation from identification to first-in-human studies, to medical practice implementation to community health dissemination;

(2) Promoting partnerships and collaborations to facilitate and accelerate translational research projects locally, regionally, and nationally;

(3) Creating, providing, and disseminating innovative research programs and partnerships across institutions and communities to address health disparities and deliver the benefits of translational science to all;

(4) Creating and implementing scientific and operational innovations that increase the quality, safety, efficiency, effectiveness, and informativeness of clinical research;

(5) Providing a national resource for the rapid response to urgent public health needs;

(6) Creating, providing, and disseminating CTS training programs for clinical research professionals of all disciplines on the research team;

(7) Creating, providing, and disseminating clinical and translational science training and career support programs for translational scientists; and

(8) Fostering the development of the emerging field of translational science.

Please see the CTSA Program for additional information.

This FOA seeks to encourage all CTSA Program hubs, in conjunction with organizations supported by NIH ICOs and/or external stakeholders if applicable, to collaboratively conceptualize, develop, or adapt multi-site innovative experimental approaches that overcome translational barriers in science, operations, and training for implementation and dissemination within and/or beyond the CTSA Program Consortium.

It is expected that, collaboratively, the projects funded under this FOA will have a transformative impact on the nation's translational science enterprise.

Specific Objectives

This FOA aims to accelerate innovative and collaborative translational science projects carried out within and/or beyond the CTSA Program Consortium that have the following characteristics:

The CCIA projects should build on the strengths and resources of each individual CTSA Program hub and could leverage translational research activities supported by NIH ICOs, and/or external stakeholders to attain a generally applicable translational science advance that no single organization can accomplish alone. Such projects should develop or adapt an innovative intervention that helps to overcome general roadblocks in science and/or operations, as well as translational science training, that limit the efficiency and effectiveness of translation. Such projects could demonstrate in one or more use cases whether the intervention is effective in accelerating research translation, utilizing clear and meaningful metrics and outcomes, when implemented across multiple CTSA Program hubs, NIH supported Programs, and/or external stakeholders. The success of the CCIA projects must be specific and measurable. If successful, such projects must have a plan to disseminate the effective intervention across and/or beyond the CTSA Program Consortium in a sustainable manner.

NCATS strongly encourages investigators from the CTSA Program hubs to form collaborations with the scientific community supported by translational research activities at NIH ICOs, including but are not limited to those stated under the components of the participating organization. Such projects could:

    •  
  • Apply the NCATS strategic principles to address translational science areas and address CTSA Program goals.
  • Include demonstration projects that address translational research areas identified in the goals and objectives of NIH ICO’s strategic plans.
  • Advance the biomedical and behavioral and social sciences through collaborative and innovative research that accelerates and expands fundamental knowledge about the nature and behavior of living systems and to apply that knowledge to enhance health, lengthen life, and reduce illness and disability.
  • Include collaborating investigators, institutions and/or external stakeholders that can mutually leverage disciplinary expertise and institutional resources.
  • Address NIH-wide strategic plan, NIH ICO’s strategic plans and/or research agendas of Trans-NIH Task Forces, Working Groups, Coordinating Committees or Initiatives (NIH Advisory Committee to the Director Meetings; NIH Medical Research Activities).

NIH Institute-, Center-, and Office-Specific Research Interests

Applications should be relevant to the objectives of the funding opportunity announcement and to at least one of the NIH Institutes’, Centers’ and Offices' research interests. Researchers are strongly encouraged to review the general research interests of the NIH ICOs, particularly those participating in this FOA. The NIH Strategic Plans and Visions can be found at https://report.nih.gov/reports/strategic-plans.

National Center for Advancing Translational Sciences (NCATS)

For the most current NCATS CTSA Program research priority areas, please see any related notice of special interest which will be linked to this FOA.

Translational science projects that collaboratively develop, adapt, demonstrate, disseminate and implement as well as evaluate innovative solutions that overcome scientific and/or operational roadblocks and accelerate translational research process. These include but are not limited to:

  • Community engagement methods and technologies that 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.
  • Education and training of translational research workforce through initiatives across multiple CTSA Program hubs, NIH ICO’s translational research activities and/or external stakeholders that leverage local, regional or national strengths, using innovative features such as shared online resources, competency-based training, training in multi-disciplinary collaborative science, regulatory science, entrepreneurship and experiential learning experiences.
  • Network capacity building within and/or beyond CTSA Program Consortium to identify and fast-track particularly promising translational research projects, thereby reducing the time required for intervention development or validation of feasibility.
  • Integration and translation of basic science and applied science for biomedical and behavioral research.
  • Application of technology and methodology that are shown to be successful in other domains to address challenges in clinical and translational science.
  • Transformative technologies (such as digital health, telehealth, data science, artificial intelligence, machine learning) to increase efficiency during implementation of clinical research studies or clinical trials (e.g., study site selection and activation, recruitment and retention, patient reported outcomes, biomarker identification and validation, data collection and analysis, risk communication, clinical monitoring, data and safety monitoring, interoperability of electronic health record systems and clinical research data management systems).
  • Rapid response to urgent public health needs (e.g., opioid epidemic, Covid-19 pandemic, health disparity).
  • Processes to establish or integrate multi-site cohorts of population of interest (e.g., pregnant women, rural population, underserved population).
  • Strategies to engage understudied/underreported populations in clinical research and clinical trial.
  • Best practices to address anticipated obstacles encountered during the conduct of clinical research and clinical trial (study site start-up, participant enrollment, consenting process, customized contract and agreement, implementation of single-IRB policy, regulatory approval, distribution of investigational products, transparency and building trust).
  • Assessment of and approaches to improve clinical research and clinical trial efficiency (e.g., local and central IRB review duration, clinical trial designs, virtual clinical trials, hybrid and decentralized clinical trials).
  • Strategies to integrate resources of CTSA Program with NIH ICO’s translational research activities and/or external stakeholders (e.g., data interoperability, common data elements, tribal regulations, research policies from sister federal agencies, NIH clinical trial networks, training resources).
  • Customized training modalities targeting the needs of academic and non-academic clinical researchers (e.g., investigators, study coordinators, research pharmacists, patient investigators, community health workers, doulas, allied health professionals, physician assistants, nurse practitioners, midwives).
  • Expansion of clinical research and clinical trial capacity beyond the academic or research institutions (e.g., dialysis centers, community hospitals, physician’s clinics, urgent care centers, nursing homes).
  • Innovative and collaborative approaches to integrate local and regional clinical research networks and/or clinical data warehouses.
  • Creative approaches to ensure surge capacity of clinical research professionals to rapidly respond to urgent public health needs.
  • Leverage of Veterans Health Administration for system-wide implementation of new and disruptive approaches to address the health burdens of veterans and improve veteran’s health.
  • Clinical, genetic or machine-learning approaches that speed the identification or accurate diagnosis of rare disease patients to shorten the diagnostic odyssey encountered by rare disease patients.
  • Approaches that more rapidly identify the molecular underpinnings of rare genetic diseases and potential targets for therapeutics development, such as computationally-assisted modeling.
  • Development and use of master protocols, such as basket, umbrella or platform trials, that include “many-diseases-at-a-time” approaches for rare disease therapeutics development.
  • Clinical trial readiness strategies, such as adapting and validating clinical outcome assessment tools, e.g., patient-, observer- or clinician-reported outcomes or assessment tools or scales, for rare disease-specific indications.
  • Clinical studies of genome editors in the treatment of multiple rare genetic diseases.
  • Strategies leveraging real world evidence (RWE)/real world data (RWD) collection to identify and test new uses of off-patent drugs that are marketed in the U.S. for a different indication (Please see Envisioning an actionable research agenda to facilitate repurposing of off-patent drugs).
  • Innovative applications and integration of data science, informatics tools and/or artificial intelligence/machine learning to make data more meaningful, open and accessible for the scientific community (predictive modeling, algorithms, simulation technologies, creation and dissemination of knowledge networks).
  • Good Algorithm Practices (GAPs) which includes model validation, data integrity, and generalizability (Please see Machine Intelligence in Healthcare).

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

The mission of the National Institute of Arthritis and Musculoskeletal and Skin Diseases is to support research into the causes, treatment, and prevention of arthritis and musculoskeletal and skin diseases. In the context of this FOA, the NIAMS is interested in research from collaborative research teams focused on innovative solutions designed to accelerate the translation of scientific knowledge to interventions that improve the treatment of NIAMS mission relevant diseases.

National Institute of Dental and Craniofacial Research (NIDCR)

NIDCR seeks to support collaborative translational research that aims to expedite the development and implementation of prevention, early detection and diagnosis, and treatment strategies for dental, oral, and craniofacial and other related diseases across the lifespan. An application must have PD(s)/PI(s) affiliated with one or more US dental schools.

National Institute of General Medical Sciences (NIGMS)

NIH/NIGMS Institutional Development Award (IDeA) Networks for Clinical and Translational Research (IDeA-CTR) funds statewide or multi-state regional networks that (1) support the development and/or enhancement of infrastructure and human resources required to address clinical and translational research needs in IDeA-eligible states/jurisdictions, (2) strengthen clinical and translational research that addresses the broad spectrum of health challenges faced by populations in IDeA-eligible states/jurisdictions, and (3) foster and coordinate collaboration in clinical and translational research within an IDeA-CTR network and with other institutions.

Office of Research on Women’s Health (ORWH)

The Office of Research on Women’s Health focuses on research that is relevant to the health of women across the life course and advancing science where the consideration of sex and/or gender influences on health are integrated across the biomedical research enterprise. The NIH vision for the health of women is that every woman receives evidence-based disease prevention, diagnosis, and treatment tailored to her own needs, circumstances, and goals. In the context of this FOA, ORWH is interested in advancing rigorous research relevant to the health of women, fostering innovation, and addressing at least one of the strategic goals of the Trans-NIH Strategic Plan for Women's Health Research "Advancing Science for the Health of Women". Research from collaborative research teams or small businesses focused on innovations designed to accelerate the translation of knowledge addressing women’s health issues of public importance is strongly encouraged. ORWH has special interest in studies focused on but not limited to morbidity and mortality in pregnant and postpartum persons including the interpregnancy interval; studies focused on pre-pregnancy health and reproductive transitions; mechanistic studies addressing co- or multi-morbidities and chronic debilitating conditions in women; and studies that consider sex and/or gender influences in COVID-19 research.

For all ICOs, examples of projects that would not be responsive to this FOA include:

  • Translational research projects focused on a specific disease that does not have broader implications for translational science.
  • Translational research projects focused on basic research.
  • Translational research projects that lack innovative and collaborative approach and prospect of accelerating translational research process.
  • Projects that include administration of pilot programs or pilot modules.
  • Applications that do not include both UG3/UH3 Phases and a milestone plan attachment.
  • Applications with total UG3/UH3 project period greater than 5 years.
  • Applications that do not include a budget and budget justification for both the UG3 Phase and UH3 Phase.
  • Applications that do not involve at least three active eligible organization as of the due date of the application.
  • Applications that do not include a letter of support from each collaborating organization.
  • Applications that do not include signed eligibility statements.
  • Applications that do not include a resource and data sharing plan.
  • Applications that do not include a sustainability plan attachment.
  • Applications in response to NICDR research priority statement that do not include PD(s)/PI(s) affiliated with one or more US dental schools.

Applications that are non-responsive and/or proposing projects not supported by this FOA will not be reviewed.

Funds may not directly support any clinical trial beyond Phase IIB with the exception of Phase III clinical trials for treatment of rare diseases. Projects that do not meet these clinical trial limitations will not be reviewed. See NOT-TR-18-025.

Funding Mechanism

This FOA will use the UG3/UH3 Cooperative Agreement mechanism. This funding mechanism involves two phases. Both phases are required in the application. Delineation of scientific and/or operational milestones is a key characteristic of this FOA. A milestone is defined as a scheduled event in the project timeline that signifies the completion of a major project stage or activity. Milestones must be performance-based to enhance the likelihood that the project will be completed on-time and on-budget. The application must include a milestone plan that proposes well-defined set of milestones for the UG3 Phase and the UH3 Phase as well as a list of specific milestones (i.e., justifiable go/no go criteria) for transition from UG3 Phase to UH3 Phase.

The UG3 Phase will support the development, adaptation, and/or demonstration of an innovative intervention that accelerates the translational research process and turns observations into interventions to improve health more quickly. A feasibility assessment must be conducted in the UG3 Phase to ensure an innovative intervention can be successfully disseminated and implemented in the next phase. If successful, the UH3 Phase will support the dissemination and implementation as well as the evaluation of an innovative intervention to be carried out among the collaborating organizations within and/or beyond the CTSA Program Consortium. In the event of an award, the PD(s)/PI(s) and NCATS staff will negotiate the final list of milestones for each year of support and the go/no go criteria for transition to the UH3 Phase.

The total project period for the UG3/UH3 Cooperative Agreement mechanism cannot exceed 5 years. Flexibility is allowed for the UG3 Phase (up to 1 - 3 years) and the UH3 Phase (up to 2 - 4 years). UG3 Phase and UH3 Phase will generally not be awarded in the same NIH fiscal year. Examples of allowed UG3/UH3 Phases include:

  • UG3/UH3 (up to 5 years): UG3 (up to 1 year) / UH3 (up to 4 years)
  • UG3/UH3 (up to 5 years): UG3 (up to 2 years) / UH3 (up to 3 years)
  • UG3/UH3 (up to 5 years): UG3 (up to 3 years) / UH3 (up to 2 years)

The UG3 Phase:

The UG3 Phase could include disease, target or subpopulation specific demonstration projects that can be generalized to multiple diseases, targets or subpopulations. An assessment must be conducted to determine the feasibility to successfully disseminate and implement an innovative intervention in the next phase. The UG3 Phase must include specific and quantifiable outcome based milestones to measure the success of developing or adapting and demonstrating an innovative intervention among the collaborating organizations within and/or beyond the CTSA Program Consortium. With NCATS approval, the peer-reviewed milestones for the UG3 Phase may be revised as activities in this phase progress.

Transition to the UH3 Phase:

An administrative review of the extent to which peer-reviewed milestones are satisfactorily met in the UG3 Phase will determine whether the UH3 Phase award will be issued, subject to NCATS funding availability. With NCATS approval, the proposed milestones for the UH3 Phase may be revised as activities in the UG3 Phase progress and are completed during the last year of support in the UG3 Phase. If at any time the project fails to make progress toward meeting milestones, NCATS will consider ending support and negotiating an orderly close-out of the award. Applicants and recipients of UG3 funding should note that the UG3 award does not guarantee subsequent UH3 funding. The justifiable go/no go criteria to determine whether a UG3 Phase will transition into the UH3 Phase will be negotiated between NCATS staff and the applicants prior to funding.

The UH3 Phase:

The UH3 Phase could include additional demonstration projects to illustrate generalizability of disease, target or subpopulation specific innovative interventions described in the UG3 Phase to multiple diseases, targets or subpopulations. In addition, rigorous methods must be applied to evaluate whether an innovative intervention accelerates the translational research process and improve the efficiency and effectiveness of many aspects of translational research. The UH3 Phase must include specific and quantifiable outcome based milestones to measure the success of disseminating and implementing as well as evaluating an innovative intervention among the collaborating organizations within and/or beyond the CTSA Program Consortium. With NCATS approval, the peer-reviewed milestones for the UH3 Phase may be revised as activities in this phase progress.

Applications submitted without a well-defined set of milestones for the UG3 Phase and the UH3 Phase as well as a list of specific milestones (i.e., justifiable go/no go criteria) for the transition from UG3 Phase to UH3 Phase will be considered non-responsive and will not be reviewed.

Pre-Application Consultation:

Applicants are strongly encouraged to consult with NCATS about their proposal early in the planning of an application. This early contact will provide an opportunity to discuss and clarify NIH policies and guidelines, including the scope of the project and intent of this FOA. See also Applicant Webinar information. Please contact NCATS at CTSA_COLLABORATIVEINNOVATION@mail.nih.gov.

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

Section II. Award Information

Funding Instrument

Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this FOA.

Application Types Allowed
New
Resubmission

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA.

Clinical Trial?

Optional: Accepting applications that either propose or do not propose clinical trial(s).

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

NCATS intends to commit up to $6 million per Fiscal Year for the CCIA Awards.

Award Budget

Application budgets need to reflect the actual needs of the proposed project.

Direct cost funding support may not exceed $650,000 per year for the UG3 Phase of awards and $650,000 per year for the UH3 Phase awards.

Award Project Period

The scope of the proposed project should determine the project period.

The project period may be up to 1- 3 years for the UG3 phase.

The project period may be up to 2 - 4 years for the UH3 phase.

The maximum project period for the entire UG3/UH3 award is 5 years.

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

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

For both UG3 and UH3 Phases, an application must involve investigators (as PDs/PIs or Co-investigators) who are from prime or partnering organizations where there are currently active CTSA Program hubs as of the due date of the application. Applicants must be from at least 3 eligible organizations and may choose one of the following options:

Option 1 – The UG3/UH3 must include investigators representing at least three different currently active CTSA Program hubs as of the due date of the application.

Option 2 – The UG3/UH3 application must involve investigators from at least two different currently active CTSA Program hubs and one or more currently active organizations from the participating NIH ICOs listed below, as of the due date of the application. For this option, the contact PD/PI named on the application must be an investigator from a prime or partnering organization where there is currently an active CTSA Program hub as of the due date of the application.

A CTSA Program hub is defined as a UL1 award with a linked KL2 award and an optional TL1 award or a UM1 award. A hub that is in extension status is not considered a currently active CTSA hub (please see CTSA Program Directory). A CTSA Program hub includes the prime recipient organization of the CTSA Program hub UL1 or UM1 award, as well as any organizations listed as partners in the CTSA Program hub UL1 or UM1 awards. Please see the definition of partnering organizations in PAR-18-940 and PAR-21-293. For option 2, the NIH program organizations of participating ICOs described below include only the prime recipient organization of the NIH Program award. If the collaboration involves the recipient organization and partnering organization of the same UL1 award, UM1 award or participating NIH Program award, these organizations are considered as a single eligible organization for the purpose of meeting the minimum number of eligible organizations as described above. If the NIH program organizations of participating ICOs described below are partnering organizations of the CTSA Program hub UL1 or UM1 awards, these organizations are not considered as a single eligible organization for the purpose of meeting the minimum number of eligible organizations as described above. Interested applicants must ensure with each of the collaborating CTSA hub and NIH Program organizations the current funding status as of the due date of the application. Please consult with the prime recipient organization of the CTSA Program hub UL1 or UM1 awards and prime recipient organizations of NIH program awards of participating ICOs described below.

Only the listed NIH programs of participating ICOs are eligible as qualifying organizations under Option 2 for this FOA, as follows:

NCATS Rare Diseases Clinical Research Consortia Eligible Grants are funded under the following Funding Opportunity Announcements:

NIAMS Eligible Grants are funded under the following Funding Opportunity Announcements:

NIGMS Eligible Grants are funded under the following Funding Opportunity Announcements:

NIMHD Eligible Grants are funded under the following Funding Opportunity Announcements:

For the most current eligible grants and their funding opportunity announcements, please see the related notices which will be linked to this FOA.

Foreign Institutions

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. 

Required Registrations

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.

  • System for Award Management (SAM) – 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.
    • Unique Entity Identifier (UEI)- A UEI is issued as part of the SAM.gov registration process. SAM registrations prior to fall 2021 were updated to include a UEI. For applications due on or after January 25, 2022, the UEI must be provided on the application forms (e.g., FORMS-G); the same UEI must be used for all registrations, as well as on the grant application.
    • Dun and Bradstreet Universal Numbering System (DUNS) – Organization registrations prior to April 2022 require applicants to obtain a DUNS prior to registering in SAM. By April 2022, the federal government will stop using the DUNS number as an entity identifier and will transition to the Unique Entity Identifier (UEI) issued by SAM. Prior to April 2022, 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.
  • eRA Commons - Once the unique organization identifier (DUNS prior to April 2022; UEI after April 2022) is established, organizations can register with eRA Commons in tandem with completing their full SAM and Grants.gov registrations; all registrations must be in place by time of submission. 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 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.

Eligible Individuals (Program Director/Principal Investigator)

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.

See Notice of NIH’s Interest in Diversity, NOT-OD-20-031

See Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019

NCATS encourages multiple PDs/PIs, particularly when each brings a unique perspective and skill set to the project. PDs/PIs who are Early Stage Investigators or those in the early stages of independent careers must propose multiple PDs/PIs with investigator(s) who have previously competed successfully as PD/PI for substantial NIH independent research funding from NIH.

The contact PD/PI must be an investigator from a prime or partnering organization where there is currently an active CTSA Program hub as of the due date of the application. Investigators who are not from CTSA hubs(such as investigators who are from a participating organization supported by NIH ICOs and/or external stakeholder),but who wish to bring an innovative project to the CTSA Program, can co-direct a project using the multiple PD/PI option in collaboration with a contact PD/PI.

See required Letters of Support.

Eligibility Statement (no more than one page)

For both UG3 and UH3 Phases, the application must include at least one PD/PI with expertise in translational science to collaborate with the project investigators in developing, adapting, demonstrating, disseminating, implementing, and evaluating interventions to accelerate the translational research process. Translational science expertise is defined as having at least one year of affiliation in a CTSA program role such as an investigator directly supported by a currently active CTSA Hub UL1, UM1 or RC2 program as of the due date of the application as well as alumni from a currently active CTSA Hub KL2/K12, TL1/T32 or Diversity and Re-entry program as of the due date of the application. Current trainees and scholars affiliated with CTSA Hub KL2/K12 and TL1/T32 programs as well as current trainees and alumni from the short-term CTSA Hub TL1 and R25 programs will not be considered to have translational science expertise.

Applications must include an Eligibility Statement signed by the CTSA affiliated program contact PD/PI that provides a description of the translational science expertise and period of affiliation on the applicable CTSA program. Applicants without the signed Eligibility Statement and/or incomplete description will not be reviewed

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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, per 2.3.7.4 Submission of Resubmission Application. 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 2.3.9.4 Similar, Essentially Identical, or Identical Applications)

Section IV. Application and Submission Information

1. Requesting an Application Package

The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace 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.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide 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.

Letter of Intent

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:


Carol Lambert, Ph.D.
Telephone: 301-435-0814
Fax: 301-480-3660
Email: Lambert@mail.nih.gov

Page Limitations

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

Instructions for Application Submission

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.

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424(R&R) Other Project Information

All instructions in the SF424 (R&R) Application Guide must be followed except where instructed to do otherwise (in this FOA or in a Notice from NIH Guide for Grants and Contracts).

Other Attachments: The following "Other Attachments" must be included to aid in the review of applications.

Milestone Plan (use filename Milestone Plan): Include a description of the proposed milestone plan in a single attachment (Limited to Three Pages). Provide clearly defined and appropriate measurable annual milestones for both the UG3 phase and the UH3 phase. Describe the methods that will be used to reach the milestones. Annual milestones must be feasible to be accomplished during the proposed timeframe. Provide a timetable (e.g., Gantt Chart) identifying when each of the key milestone will be met after UH3 phase and Annual milestones. In the event the UG3 and/or UH3 milestones are not achieved, contingency plans must be provided. The plan must propose justifiable go/no go criteria for continuation from UG3 Phase into UH3 Phase.

Sustainability Plan (use filename Sustainability Plan): Include a description of the proposed sustainability plan in a single attachment (Limited to Two Pages). Provide a proposal to sustain and/or expand the dissemination and implementation of the innovative interventions, deliverables and/or products of the project besides the collaborating organizations within and/or beyond the CTSA Program Consortium after the end of award period. Describe the proposed approach for adoption of the innovative interventions, deliverables and/or products of the project by the stakeholders. If applicable, describe how the existing resources provided by NCATS (e.g., the CTSA Consortium-Wide Centers: Resources for Rapid Demonstration & Dissemination - PAR-22-122) and the resources provided by NIH ICOs and/or external stakeholders can be leveraged.

Applications submitted without the Milestone Plan and Sustainability Plan and/or applications using these attachments to circumvent the NIH standard page limits as described in the general application guide instructions will be considered incomplete and will not be reviewed.

SF424(R&R) Senior/Key Person Profile

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

R&R Budget

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

The application must include a budget and budget justification for both the UG3 Phase and UH3 Phase.

R&R Subaward Budget

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

PHS 398 Cover Page Supplement

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

PHS 398 Research Plan

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

This funding mechanism involves UG3/UH3 Phases. To clearly distinguish between the two phases, applicants must specify separate UG3 and UH3 information in each subsection (Specific Aims and Research Strategy) of the PHS 398 Research Plan as appropriate. Activities in both phases will depend on the specific project. In preparing the application, investigators must consider the fact that applications will be assigned a single impact score for both UG3 and UH3 Phases.

Specific Aims: Applicants must address the translational science (e.g., operational barrier) and translational research (e.g., scientific barrier) questions to be answered in separate specific aims, what specifically will be done during the proposed funding periods and the impact of addressing barriers during the translational research process that are disease agnostic. Specific aims must be scientifically appropriate for the distinct phases of the project. Include separate aims, within the designated page limit, for both the UG3 and UH3 Phases, and clearly label them as UG3 specific aims and UH3 specific aims. Briefly state the specific aims of the project indicating how the project will contribute to advancing translational science. Both the UG3 and UH3 Phase must specify at least one specific aim that answers a translational science question.

Research Strategy: This section should include:

Overall Impact Statement:

A statement of the significance and powerful influence of the project on the advancement of the translational science. Describe how the project will apply the NCATS strategic principles to address translational science areas and address CTSA Program goals. Describe how the project will align with either the NIH-wide strategic plan, NIH ICO’s strategic plans and/or research agendas of Trans-NIH Task Forces, Working Groups, Coordinating Committees or Initiatives (NIH Advisory Committee to the Director Meetings; NIH Medical Research Activities).

Summarize the critical gap in translational science and/or the significance of operation barrier to be addressed and how these can be overcome by an innovative solution. Include a statement of how, if successful, the specific translational research question, that focuses on the specific case of a target or disease, can be generalizable to other targets or diseases. Summarize the teamwork performed by the collaborating investigators at the CTSA Program hubs, organizations supported by NIH ICOs and/or external stakeholders in which the interaction translates into the concept of “The whole is greater than the sum of its parts”. Summarize how the intervention will innovate and transform the current translational research process and its effect on some domain of translational science. Summarize how the deliverables and outcomes available at the completion of the project will improve the efficiency and effectiveness of clinical translation from identification to first-in-human studies to medical practice implementation to community health dissemination.

A description of the overall strategy and methodology used to accomplish the goals and specific aims of the project. The description must address the following:

Collaboration: Describe how the project will stimulate complementary and/or synergistic collaborations to build on the strength and resources of each collaborating organization (e.g., CTSA Program hub, organizations supported by NIH ICOs, external stakeholder) while generating innovative interventions to attain a generally applicable translational science advance that no single organization can accomplish alone. State whether the collaboration is to either: 1) form new collaborations, or to 2) significantly expand the scientific scope of existing collaborations, or to 3) engage new collaborators in pre- existing collaborations to address the translational science challenge. Describe how the project will involve interdisciplinary and/or trans-disciplinary collaboration. Describe the complementary and/or synergistic efforts that each collaborator will contribute to both phases of the project. Describe the plans and timeframe for how multiple collaborators will participate in this research, identify those responsible for various efforts, declare milestones, metrics, individual responsibilities, timelines and plans for dissemination and implementation as well as evaluation.

Innovation: Provide a description of and rationale for the proposed innovation. Describe, if successful, how the proposed innovation transforms some domains of translational science. The description must explain how the project is innovative. When no available intervention is suitable, the project may include the development of a novel intervention. When a suitable intervention exists, the project may include the choice of approach, and how an existing intervention is used in an innovative manner to advance translation. Describe the innovative use of an existing intervention in various populations (e.g., underserved populations, underrepresented minority populations) and/or different environments (e.g., academic or community settings, urban and rural areas, socio-economic levels). Discuss how the project might open a new avenue of translational research or might be a systematic improvement over the current processes used in translational research. Discuss how the project applies big, bold, paradigm-shifting ideas to advance translational science.

Acceleration: Describe how the project will catalyze a transformation so that observations and discoveries in the laboratory, clinic, and community turn into biomedical and behavioral interventions to improve health for all people and communities more quickly. Describe how the project will streamline the current timeline of translational research process. Describe how the project will enable stakeholders to perform translational research more efficiently and effectively. Apply the NCATS description of translational science spectrum (i.e., the spectrum is not linear or unidirectional; each translational science stage builds upon and informs the others) to accelerate the translation research process. Describe the evaluation methods to assess the acceleration aspects of the project. Describe how the project will speed the development, demonstration, dissemination and implementation of innovative interventions in research areas described in the CTAS Program goals and/or NIH-wide strategic plan, NIH ICO’s strategic plans and/or research agendas of Trans-NIH Task Forces, Working Groups, Coordinating Committees or Initiatives (NIH Advisory Committee to the Director Meetings; NIH Medical Research Activities.) Describe the methodologies that will yield the scientific evidence for innovative interventions to accelerate the translational research process relative to current research, clinical, and public health practice paradigms. Describe how the project will apply innovative interventions for a disease to other diseases. Describe how the project will apply innovative interventions for a specific subpopulation to other subpopulations.

Dissemination & Implementation: Describe how the innovative intervention will be disseminated and implemented in a targeted scientific, clinical, community or public health setting. Describe how the collaborators will use strategies to adopt, scale-up and integrate the innovative interventions into different environments to improve individual outcomes and benefit population health. Discuss how the project will engage the collaborating organizations for dissemination and implementation of innovative interventions.

Evaluation: Describe how the project can leverage the resources and expertise from the evaluation component of the collaborating CTSA Program hubs. Define success for the proposed project and describe how success can be evaluated and quantified.

Risks to the Project: Identify any perceived implementation problems or ethical issues during the startup, conduct and closeout of the project. Propose solutions to mitigate or eliminate the foreseeable risks that can jeopardize the completion and success of the project. Describe potential contingency plans and alternative approaches to completing the goals and specific aims of the project. Describe the management plan to address the unforeseeable risks to the project.

Sustainability: Since the CCIA Awards are not renewable, application must include an attachment titled Sustainability Plan that describes a proposal to sustain and/or expand the dissemination and implementation of the innovative interventions, deliverables and/or products of the project besides the collaborating organizations within and/or beyond the CTSA Program Consortium after the end of award period. Describe the proposed approach for adoption of the innovative interventions, deliverables and/or products of the project by the stakeholders. If applicable, describe how the existing resources provided by NCATS (e.g., the CTSA Consortium-Wide Centers: Resources for Rapid Demonstration & Dissemination - PAR-22-122) and the resources provided by NIH ICOs and/or external stakeholders can be leveraged.

Letters of Support: Each collaborating investigator is required to include a letter of support from the contact PD/PI of the CTSA Program hub, contact PD/PI of the participating NIH ICO programs, and/or the external stakeholder’s organization that they are associated with. For multiple investigators from the same CTSA Program hub, one letter of support from the CTSA Program PD/PI is sufficient. Where relevant, include letters of support or other documentation of collaborative effort with the external stakeholders. For drug or device trials, provide evidence that the study drug or device will be available in sufficient quantities to ensure study feasibility. Letters of support must detail how the CTSA Program hub(s) or the participating NIH ICO programs will provide support to the project (e.g., resources and assistance in dissemination of the outcomes of the project within and/or beyond the CTSA Program Consortium).

Applications submitted without the required letters of Support from the contact PD/PI of the CTSA Program hub, contact PD/PI of the participating NIH ICO programs, and the external stakeholder’s institution or organization will be considered incomplete and will not be reviewed.

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, must address a Data Sharing Plan.
  • Applications submitted to NIH after January 25, 2023, must comply with the final NIH Policy for Data Management and Sharing. See Related Notices associated with this funding opportunity.

Leveraging Existing Research Resources

To maximize consortium research and rapidly implement approaches to address the gaps in translational science, whenever possible applicants should leverage, adopt or adapt resources from ongoing NIH-supported efforts or other nationally recognized efforts to allow comparisons across datasets and/or data integration as these are essential to collaboration and acceleration of translation research process. Projects funded through this FOA are strongly encouraged to include but are not limited to the following resources as applicable:

Resources Provided by NCATS

Specified support services will be provided through grants, contracts, and/or NCATS for certain CCIA activities, e.g., use of a specified NCATS vendor for organization of workshops or provision of certain CCIA-related data. Specific requirements for UG3/UH3 recipients are detailed in the Terms and Conditions of award. In support of the NCATS’ goal of promoting and facilitating the development and dissemination of interoperable assets, such as algorithms and software, the NCATS Information Resources Technology Branch (ITRB) may provide access to various public cloud services and high-performance computing services for the needs of the recipients. This enables the recipients to offer their systems, projects, and research in a secure environment with simplified implementation, deployment and operational reliability. Through these services, NCATS ITRB will enable the recipients to gain a self-service capability. NCATS ITRB may provide the following, pending consultation with the recipient and the NCATS Program Official:

  • Infrastructure as a Service (IaaS) or Platform as a Service (PaaS) on any of the major public cloud providers via NCATS' Federated Authorization Service.
  • Access to NCATS' Federated Authorization Software as a Service (SaaS) to any of the CTSA recipient systems and applications, various Common Cloud Engineering and Support Services.
Appendix:
Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
PHS Human Subjects and Clinical Trials Information

When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.

PHS Assignment Request Form

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

3. Unique Entity Identifier and System for Award Management (SAM)

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

4. Submission Dates and Times

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.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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.

7. Other Submission Requirements and Information

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 How to Apply – Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. 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 fieldof the Senior/Key Person Profile form. 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 unique entity identifier (DUNS number or UEI as required) provided 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, NIH. Applications that are incomplete or non-compliant will not be reviewed.

In order to expedite review, applicants are requested to notify the NCATS Referral Office by email at ncatsreferral@mail.nih.gov when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.

 

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process.  Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

This FOA will use the UG3/UH3 Cooperative Agreement mechanism. This funding mechanism involves two phases. Both phases are required in the application. Delineation of scientific and/or operational milestones is a key characteristic of this FOA. A milestone is defined as a scheduled event in the project timeline that signifies the completion of a major project stage or activity. Milestones must be performance-based to enhance the likelihood that the project will be completed on-time and on-budget. The application must include a milestone plan that proposes well-defined set of milestones for the UG3 Phase and the UH3 Phase as well as a list of specific milestones (i.e., justifiable go/no go criteria) for transition from UG3 Phase to UH3 Phase.

The UG3 Phase will support the development, adaptation, and/or demonstration of an innovative intervention that accelerates the translational research process and turns observations into interventions to improve health more quickly. A feasibility assessment must be conducted in the UG3 Phase to ensure an innovative intervention can be successfully disseminated and implemented in the next phase. If successful, the UH3 Phase will support the dissemination and implementation as well as the evaluation of an innovative intervention to be carried out among the collaborating organizations within and/or beyond the CTSA Program Consortium.

A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.

Overall Impact

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).

Scored Review Criteria

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.

Significance

Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Specific to this FOA:

To what extent does the project address significant scientific and/or operation barriers that are disease agnostic? To what extent does the project apply NCATS strategic principles to address important translational research questions? If the project succeeds, how will it be generalizable to other targets or diseases? To what extent do the goals and specific aims of the project align with either the NIH-wide strategic plan, NIH ICO’s strategic plans and/or research agendas of Trans-NIH Task Forces, Working Groups, Coordinating Committees or Initiatives (NIH Advisory Committee to the Director Meetings; NIH Medical Research Activities)? To what extent are the CTSA Program goals addressed in the project?

In addition, for applications involving clinical trials

Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy? For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Specific to this FOA:

To what extent does each collaborating investigator make a significant contribution to the overall project? To what extent do one or more of collaborating investigators have the expertise in translational science and/or translational research area of interest? To what extent will the project involve interdisciplinary and/or trans-disciplinary collaborators? To what extent are the contributions from each collaborator complementary and/or synergistic in both phases of the project? To what extent does the project describe the plans and timeframe for how multiple collaborators will participate in this research, identify those responsible for various efforts, declare milestones, metrics, individual responsibilities, timelines and plans for dissemination and implementation as well as evaluation?

In addition, for applications involving clinical trials

With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Specific to this FOA:

To what extent does the project propose a pioneering intervention that will transform the way the researchers address a scientific and/or operation barrier not only in the translational research area of interest, but also generalizable to translational research challenges across different targets and diseases? To what extent does the project propose to develop a new intervention or adapt an existing intervention in an innovative manner to advance translation? To what extent does the project describe the innovative use of an existing intervention in diverse study populations (e.g., underserved populations, minority populations) and/or different environments (e.g., academic or community settings, urban and rural areas, socio-economic levels)? To what extent might the project open a new avenue of translational research or be a systematic improvement over the current processes used in translational research? To what extent does the project apply big, bold, paradigm-shifting ideas to advance translational science?

In addition, for applications involving clinical trials

Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

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 individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

Specific to this FOA:

To what extent does the project describe the approach for integrating the translational science principles into the translational research process? To what extent does the project take into consideration the UG3/UH3 funding mechanism in describing the approach to achieve the goals and the specific aims? To what extent does the feasibility assessment conducted in the UG3 Phase ensure the success of dissemination and implementation of an innovative intervention in the UH3 Phase? To what extent does the project improve the efficiency and/or effectiveness of translational research process? To what extent will the project apply an innovative intervention for a disease or a specific subpopulation to other diseases or other subpopulations? To what extent have the investigators considered and addressed potential risks to success, and discussed contingency plans and described alternative approaches?

In addition, for applications involving clinical trials

Does the application adequately address the following, if applicable

Study Design

Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?

Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?

Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?

Data Management and Statistical Analysis

Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

Specific to this FOA:

To what extent does the project leverage and build on the existing strengths and resources of each collaborating organization to attain a generally applicable translational science advance that no single organization can accomplish alone? To what extent does the project describe the support and enthusiasm from the stakeholders at the collaborating organizations to ensure the success of the project?

In addition, for applications involving clinical trials

If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?

Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?

If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?

If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?

Additional Review Criteria

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.

Milestone Plan

To what extent are the milestones clearly stated? To what extent are the key milestones that need to be met for each UG3 and UH3 Phase to ensure success of the project adequate and reasonable?

For both the UG3 and UH3 Phases, to what extent are appropriate, measurable annual milestones clearly defined for each phase? How likely the investigator team will meet these milestones within the proposed project period for each phase? To what extent is the project performance timeline for each phase feasible to accomplish the proposed activities within the proposed timeframe?

To what extent does the milestone plan propose justifiable go/no go criteria for continuation from UG3 Phase into UH3 Phase? To what extent does the application address contingency plans in the event the UG3 and/or UH3 milestones are not achieved?

Sustainability Plan

To what extent does the application describe a plan to sustain and/or expand the dissemination and implementation of the innovative interventions, deliverables and/or products of the project besides the collaborating organizations within and/or beyond the CTSA Program Consortium after the end of award period? To what extent does the application describe the proposed approach for adoption of the innovative interventions, deliverables and/or products of the project by the stakeholders? If applicable, to what extent does the application describe how the existing resources provided by NCATS (e.g., the CTSA Consortium-Wide Centers: Resources for Rapid Demonstration & Dissemination - PAR-22-122) and the resources provided by NIH ICOs and/or external stakeholders can be leveraged?

Study Timeline

Specific to applications involving clinical trials

Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate?

Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?

Protections for Human Subjects

For research that involves human subjects but does not involve one of the 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 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.

Inclusion of Women, Minorities, and Individuals Across the Lifespan

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 individuals of all ages (including children and older adults) 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.

Vertebrate Animals

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.

Biohazards

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.

Resubmissions

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Renewals

Not Applicable

Revisions

Not Applicable

Additional Review Considerations

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.

Applications from Foreign Organizations

Not Applicable

Select Agent Research

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).

Resource Sharing Plans

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

Authentication of Key Biological and/or Chemical Resources:

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.

Budget and Period of Support

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

2. Review and Selection Process

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.

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.

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. 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.

3. Anticipated Announcement and Award Dates

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.

Section VI. Award Administration Information

1. Award Notices

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 recipient's business official.

Recipients 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.

Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.

ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain “applicable clinical trials” on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration and results reporting of all trials whether required under the law or not. For more information, see https://grants.nih.gov/policy/clinical-trials/reporting/index.htm

Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).

Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).

2. Administrative and National Policy Requirements

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, Recipients, and Activities, including of note, but not limited to:

If a recipient is successful and receives a Notice of Award, in accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

Should the applicant organization successfully compete for an award, recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex (including gender identity , sexual orientation, and pregnancy). This includes ensuring programs are accessible to persons with limited English proficiency and persons with disabilities. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html

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. 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.

Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.

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 75.205and 2 CFR Part 200.206 “Federal awarding agency review of risk posed by applicants.” This provision will apply to all NIH grants and cooperative agreements except fellowships.

Cooperative Agreement Terms and Conditions of Award

The following special terms of the 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, 2 CFR Part 200, 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 recipients is anticipated during the performance of the activities. Under the cooperative agreement, the NIH's 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 reside with the recipients for the project as a whole, although specific tasks and activities may be shared among the recipients and the NIH as defined below.

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

  • Defining research objectives and approaches, planning, conducting, analyzing, and publishing results, interpretations, and conclusions of their studies, and providing overall scientific and administrative leadership for the Research Project.
  • Overseeing all aspects of the organization and execution of the studies outlined in the application and approved by NCATS after peer review.
  • Putting all study materials and procedure manuals into the public domain. Recipients are expected to publish and publicly disseminate results, data, and other products of the study, 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.
  • Recipients have primary and lead responsibilities for the project as a whole, including any modification of study design, the conduct of the study, quality control, data analysis and interpretation, preparation of publications, and collaboration with other investigators unless otherwise provided for in these terms or by the action of the primary leadership committee.
  • Develop and maintain a public 508 compliant project website during the project period.
  • Make publicly accessible interim presentations of project progress on annual basis and final presentation at the completion of each UG3/UH3 Phase using an online platform and resources provided by NCATS.

Recipients will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies.

NIH staff has substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

General Area of Responsibility: The NIH Program Official / Project Coordinator (PO/PC), also known as the Project Collaborator, will be responsible for the normal scientific and programmatic stewardship of the award.

The NIH POs/PCs will:

  • Provide substantial programmatic involvement that is above and beyond the normal stewardship role in awards with substantial involvement in the proposed research project.
  • Cooperate, coordinate with, and/or assist recipients in performing project activities, e.g., coordination of research networks; coordinating access to NIH-supported research resources; identifying other researchers/resources for the projects.
  • Participate on steering and operations committees or in other functions responsible for helping to guide the course of long-term projects or activities; e.g., annual meetings.
  • Provide scientific and technical discussions with recipients, facilitate or expedite interactions between recipients, and/or identify and facilitate access to resources; e.g., organizing and holding meetings of investigators.
  • Have access to data generated under this Cooperative Agreement and may periodically review the data. NCATS staff may use information obtained from the data for the preparation of internal reports on the activities of the study. However, recipients will retain custody of and have primary rights to all data developed under these awards, subject to Government rights of access consistent with HHS, PHS, and NIH policies.
  • Serve as a resource to provide scientific/programmatic support during the accomplishment of the research by participating in the design of the activities, advising in the selection of sources or resources (e.g., determining where a particular reagent can be found), provision of research resources and reagents available from NCATS grantees and contractors, or other CTSA Program sites, advising in management and technical performance or participating in the preparation of publications.
  • If the award involves a clinical study, oversee the adequacy of adverse event management and reporting, and have regular communications with the PD/PI and study team, which may include attendance at the DSMB and related committee meetings. Review and monitor the progress of inclusion of women and minorities in the clinical trial.
  • Review the progress of each participating organization, through consideration of the annual reports, site visits, screening logs, etc.
  • Determine whether milestones are appropriate for each stage of the award. Review and approve any milestone changes.
  • Monitor study progress; as with any award, continuation, even during the period recommended for support, is contingent upon satisfactory progress. The schedule for these interim reviews will be based on the duration of the award. Continuation of funding will be dependent upon the recipient’s ability to show adequate progress.
  • Be responsible for assessing the progress of the project towards the specified milestones, and for recommending if further funds should be released to the project and whether the project should transition to the UH3 Phase.
  • Determine continued funding based on the overall robustness of the entire data that adequately allows an interpretation of the results (regardless of being captured in the milestones), overall progress, NIH portfolio balance, and program priorities, competitive landscape, and availability of funds.

Areas of Joint Responsibility include:

  • Clarifying and negotiating the project milestones and timelines.
  • Coordination of meetings, if needed, at critical milestones or transition points of the award

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 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 recipient.

This special dispute resolution procedure does not alter the recipient'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.

3. Reporting

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

When multiple years are involved, recipients 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 RPPR, 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. NIH FOAs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 45 CFR Part 75.301 and 2 CFR Part 200.301.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All recipients 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.

Section VII. Agency Contacts

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

Application Submission Contacts

eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and 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)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-945-7573

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov

Scientific/Research Contact(s)

Soju Chang, M.D., M.P.H.
National Center for Advancing Translational Sciences (NCATS)
Telephone: (301) 827-9206
E-mail: soju.chang@nih.gov

Jamie White, MS
Office of Research on Women's Health (ORWH)
Phone: 301-496-9200
E-mail: jamie.white@nih.gov

Larissa Aviles-Santa, MD, MPH
National Institute on Minority Health and Health Disparities (NIMHD)
Phone: 301-827-6924
E-mail: avilessantal@mail.nih.gov

Ming Lei, Ph.D.
National Institute of General Medical Sciences (NIGMS)
Email: leim@mail.nih.gov

Lu Wang, PhD
National Institute of Dental & Craniofacial Research (NIDCR)
Phone: 301 594-4846
E-mail: wanglu@mail.nih.gov

Aron Marquitz, PhD
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Phone: none
E-mail: marquitzar@mail.nih.gov


Melissa Parisi, MD, PhD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6880
Email: parisima@mail.nih.gov

Peer Review Contact(s)

Lourdes Ponce, Ph.D.
National Center for Advancing Translational Sciences (NCATS)
Phone: 301-435-0810
E-mail: lourdes.ponce@nih.gov

Financial/Grants Management Contact(s)

Steve Elsberg
National Center for Advancing Translational Sciences (NCATS)
Telephone: 301-435-0528
Email: steve.elsberg@nih.gov

Priscilla Grant, JD
National Institute on Minority Health and Health Disparities (NIMHD)
Phone: 301-594-8412
E-mail: pg38h@nih.gov

Diana Rutberg, MBA
National Institute of Dental & Craniofacial Research (NIDCR)
Phone: 301- 594-4798
E-mail: rutbergd@mail.nih.gov

Erik Edgerton
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Phone: 301-594-7760
E-mail: erik.edgerton@nih.gov

Margaret Young
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-642-4552
Email: margaret.young@nih.gov

Section VIII. Other Information

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.

Authority and Regulations

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 2 CFR 200, 42 CFR Part 52 and 45 CFR Part 75.

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