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)

Funding Opportunity Title

Limited Competition: Competitive Revision Awards for the Clinical and Translational Science Award (CTSA) Program (U54 Clinical Trial Optional)

Activity Code

Additional funds may be awarded as supplements to parent awards using the following Activity Code(s):

U54 Specialized Center- Cooperative Agreements

Announcement Type

New

Related Notices
  • August 23, 2019 - Clarifying Competing Application Instructions and Notice of Publication of Frequently Asked Questions (FAQs) Regarding Proposed Human Fetal Tissue Research. See Notice NOT-OD-19-137.
  • July 26, 2019 - Changes to NIH Requirements Regarding Proposed Human Fetal Tissue Research. See Notice NOT-OD-19-128.
Funding Opportunity Announcement (FOA) Number

PAR-19-337

Companion Funding Opportunity

PAR-18-464 Clinical and Translational Science Award (U54 Clinical Trial Optional)

PAR-18-940 Clinical and Translational Science Award (U54 Clinical Trial Optional)

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.350  

Funding Opportunity Purpose

The purpose of this Funding Opportunity Announcement (FOA) is to solicit competitive revision (formerly known as competitive supplement) applications from awardees with active Clinical and Translational Science Award (CTSA) Program hub awards (UL1) to support the demonstration, and/or dissemination, and/or implementation of highly innovative and impactful translational science projects that address the goals of the CTSA Program and are beyond the original scope of the approved parent project  Under this competitive revision, only applications for revisions to the UL1 award are allowed. Revisions to the linked KL2 and/or the TL1 awards are not allowed.    

Key Dates
Posted Date

August 7, 2019

Open Date (Earliest Submission Date)

August 25, 2019

Letter of Intent Due Date(s)

30 days prior to the application due date

Application Due Date(s)

September 25, 2019, September 25, 2020, September 27, 2021, by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on these dates.

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.

AIDS Application Due Date(s)

Not Applicable.

Scientific Merit Review

February 2020, February 2021, February 2022

Advisory Council Review

May 2020, May 2021, May 2022

Earliest Start Date

July 2020, July 2021, July 2022

Expiration Date

September 28, 2021

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

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


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. Table of Contents

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

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

    Part 2. Full Text of Announcement
    Section I. Funding Opportunity Description

    Purpose

    The purpose of this Funding Opportunity Announcement (FOA) is to solicit competitive revision (formerly known as competitive supplement) applications from grantees with active Clinical and Translational Science Award (CTSA) Program hub awards (UL1).  The CTSA Program supports high quality translational science and clinical research locally, regionally and nationally; fosters scientific and operational innovation to improve the efficiency and effectiveness of clinical translational research; and creates, provides and disseminates domain-specific translational science training and workforce development. This FOA solicits competitive revision applications to support the demonstration, and/or dissemination, and/or implementation of highly innovative and impactful translational science projects that address the goals of the CTSA Program that are beyond the original scope of the approved project.  Projects will be considered for an increase in support for an expansion of the parent project’s approved scope.

    Awardees funded through the following funding opportunity announcements are eligible to apply for one competitive revision per year through this funding opportunity announcement. Awardees funded through the expired FOA PAR-15-304 may apply through this funding opportunity announcement as well.

    Clinical and Translational Science Award (U54) (PAR-18-464): https://grants.nih.gov/grants/guide/pa-files/PAR-18-464.html

    Clinical and Translational Science Award (U54) (PAR-18-940): https://grants.nih.gov/grants/guide/pa-files/PAR-18-940.html

    Under this competitive revision, only applications for revisions to the UL1 award are allowed. Revisions to the linked KL2 and/or the TL1 awards are not allowed.

    Background

    The development and implementation of clinical interventions that demonstrably improve human health is currently a complex, iterative, and, at times, inefficient process that argues for new insights and innovative approaches to create efficiencies that will optimize and accelerate the translation of scientific discoveries into interventions that improve the health of individuals and the public.  To this end, the National Center for Advancing Translational Sciences (NCATS) conducts and supports research in the science of translation, to understand the mechanistic and operational principles that underlie each step of the translational process to create testable scientific hypotheses.

    Through the CTSA Program, NCATS supports an integrated research and training environment for translational and clinical science, with the goal of catalyzing the development, demonstration, and dissemination of methods and technologies that dramatically improve efficiency and quality across the translational research spectrum. The health centers that make up the CTSA Program are referred to as “hubs” to indicate their central role in their local environments where they coordinate and collaborate with multiple “spokes” such as affiliated hospitals, clinics, and community health centers.   Each CTSA Program hub functions as a local center of innovation in translational science and operations, the nature of which will build on local institutional strengths, including geographic/demographic areas of need.  In aggregate, the diverse CTSA Program hubs form a network whole that is much greater than the sum of its parts, with hubs bringing complementary strengths to each other via the CTSA Program locally, regionally, and nationally. 

    Many of the developed capabilities and resources from CTSA Program hubs have proven to be beneficial in advancing and accelerating translational science at other hubs, across the CTSA Program Consortium and beyond. This FOA solicits competitive revision applications to support projects to demonstrate, and/or disseminate, and/or implement successful and proven capabilities/resources that are beyond the scope of the UL1 parent grant.

    Specific Objectives

    This funding opportunity will provide support for the demonstration, and/or dissemination, and/or implementation of translational science projects that have been tested and validated at a specific hub or institution. Proposed projects may include existing and/or novel methods, approaches, interventions, tools, technologies and training that improve and accelerate the translational research process.  Projects may include new activities, demonstration and/or dissemination of an existing activity from a local hub to other hubs and/or institutions. All projects will require a detailed evaluation plan to inform subsequent dissemination. It is expected that this support will help catalyze the sharing, adoption and/or expansion of innovations developed at a specific hub(s) to additional CTSA Program hubs and possibly beyond.  Projects should address novel and/or emerging approaches in areas of unmet need with the overall goal of improving efficiencies in clinical and translational science. In doing so this support will further NCATS’ vision of the CTSA Program as an integrated and collaborative national network that comprises hubs that work together to improve the translational science process and get more treatments to more patients more quickly.

    Highly impactful projects are expected to demonstrate, and/or disseminate, and/or implement a capability developed at the hub (methods, tools, technologies, interventions, platforms, resources, etc.) that:

    • Build on CTSA Program hubs’ successes and reinforce areas of progress in one or more of the CTSA Program's Strategic Goals;
    • Has a high likelihood of creating a systematic improvement in clinical and translational science;
    • Has outcomes and milestones that are clearly defined and measurable;
    • Where appropriate, includes partners in addition to academic investigators (e.g. industry, patient advocates, community members, citizen scientists, professional societies); and
    • Could be expanded and made available to multiple users/communities of the CTSA Program and possibly beyond.    

    Examples of the types of projects that would be considered for support under this FOA include, but are not limited to:

    • Demonstration, and/or dissemination, and/or implementation of new activities and/or capabilities successfully developed at one hub to be tested at other hubs.
    • Efforts to promote the sharing of resources and capabilities across different CTSA Program hubs.
    • Efforts to disseminate expert knowledge and create that expert capacity at additional CTSA Program hubs.  
    • Sharing and/or expansion of a platform developed and demonstrated to be impactful in the translational science space at a single hub that will be adopted at multiple hubs.
    • Expansion of consortium-wide capabilities.

    Projects that would not be funded under this FOA include those that:

    • Lack evidence that the capability has been sufficiently developed to be ready for demonstration and/or dissemination and/or implementation to other hubs.
    • Lack evidence of an unmet need for the capability among the CTSA Program hubs (lack a needs analysis, lack of detail regarding the feasibility of the approach).
    • Lack details defining and describing the translational science nature of the project.  NCATS defines translational science as focused on understanding the scientific and operational principles underlying each step of the translational process to enable improvements and efficiencies.  (See: https://ncats.nih.gov/translation/spectrum)
    • Do not propose to disseminate and implement the capability beyond the primary hub (the primary hub includes any institutions listed as partners in the CTSA Program hub UL1 award).
    • Lack clearly defined outcomes and a description of their measurements and milestones.
    • Lack a description of plans for the sustainability of the resource or capability after completion of the funding period.

    Potential applicants are strongly encouraged to discuss their plans for responding to this FOA with their assigned NCATS Program Official named in the Notice of Award of the parent UL1 award.

    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

    Revision

    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)  

    Need help determining whether you are doing a clinical trial?

    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.

    Funds may not directly support any clinical trials beyond phase IIB with the exception of Phase III clinical trials for treatment of rare diseases. See NOT-TR-18-025.

    Award Budget

    Application budgets are limited to no more than $750,000/year in direct costs excluding consortium/contractual F&A costs.

    Award Project Period

    The UL1 parent award must be active when the application is submitted. 

    The project and budget periods must be within the currently approved project period for the existing parent UL1 award.  Supplement award budgets and project periods will be based upon the time remaining in the parent award at the time the supplement award is made.  See Section III.1 for additional information.

    The requested project period may be from one to three years provided it is within the remaining project period of the current UL1 award.    

    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

    To be eligible, the parent award (UL1) must be active (i.e. not be in an extension period), and the research proposed in the supplement must be accomplished within the remaining active project period for the existing UL1 parent award. 

    A CTSA Program hub is defined as a UL1 award with a linked KL2 award and an optional TL1 award. A hub that is in no-cost extension (NCE) status is not considered a currently funded CTSA Program hub (see https://ncats.nih.gov/ctsa/about/hubs).  CTSA Program hub institutions include the recipients of the CTSA Program hub award, as well as any institutions listed as partners in the CTSA Program hub UL1 award.

    Work must be accomplished within the remaining active project period for the existing UL1 parent award assuming a July start date for the revision. Projects with a total proposed duration of less than one year will not be accepted.

    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.

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

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

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

    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.

    The PD/PI of the revision application must be the PD/PI of the parent UL1 award.  Individual(s) must hold an active grant or cooperative agreement, and the research proposed in the supplement must be accomplished within the competitive segment of the active award. Individuals are encouraged to work with their organizations to develop applications for support. 

    The PDs/PIs of the parent grant may designate senior/key personnel to contribute to the scientific development or execution of the supplement project in a substantive, measurable way. Investigators who are not employed by and/or receive funding from a CTSA Program Institution may co-direct a project in partnership with a CTSA Program hub investigator using the multiple PD/PI option.

    For supplements to parent awards that include multiple PDs/PIs, the supplement may be requested by any or all of the PDs/PIs (in accordance with the existing leadership plan) and submitted by the awardee institution of the parent award. The PD/PI, or contact PD/PI, in applications using the multiple PD/PI option, must be employed by a CTSA Institution. Investigators who are not employed by a CTSA Institution may co-direct a project in partnership with a CTSA investigator. 

    Do not use this competitive revision application to add, delete, or change the PDs/PIs listed on the parent award. Visit the Multiple Program Director/Principal Investigator Policy in the SF424 (R&R) Application Guide for more information.  

    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.  This means that the NIH will not accept:

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

    Only one competitive revision application to a UL1 hub may be funded per year.  

    Section IV. Application and Submission Information
    1. Requesting an Application Package

    The application forms package specific to this opportunity must be accessed through ASSIST or an institutional system-to-system solution. A button to apply using ASSIST is 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 Multi-Project (M) Instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. 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
    Email: Lambert@mail.nih.gov

    Page Limitations

    Available Component Types

    Research Strategy/Program Plan Page Limits

    Overall

    6

    Project

    12

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

    Instructions for the Submission of Multi-Component Applications

    The following section supplements the instructions found in the SF424 (R&R) Application Guide, and should be used for preparing a multi-component application.

    Revision applications must include an Overall component and the components that are affected by the revision. Therefore, the component requirements listed below may not apply to the revision application.

    The application should consist of the following components:

    •          Overall: Required

    •          Project: Required, maximum of 1

    Overall Component

    When preparing your application, use Component Type ‘Overall’.

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

     
    SF424 (R&R) Cover (Overall)

    Complete entire form.

    PHS 398 Cover Page Supplement (Overall)

    Note: Human Embryonic Stem Cell lines from other components should be repeated in cell line table in Overall component.

    Research & Related Other Project Information (Overall)

    Follow standard instructions.

    Project/Performance Site Location(s) (Overall)

    Enter primary site only.

    A summary of Project/Performance Sites in the Overall section of the assembled application image in eRA Commons compiled from data collected in the other components will be generated upon submission.

    Research & Related Senior/Key Person Profile (Overall)

    Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this FOA) for the entire application.

    A summary of Senior/Key Persons followed by their Biographical Sketches in the Overall section of the assembled application image in eRA Commons will be generated upon submission.

    Budget (Overall)

    The only budget information included in the Overall component is the Estimated Project Funding section of the SF424 (R&R) Cover. 

    A budget summary in the Overall section of the assembled application image in eRA Commons compiled from detailed budget data collected in the other components will be generated upon submission.

    PHS 398 Research Plan (Overall)

    Introduction to Application: For Revision applications, an Introduction to Application is required in the Overall component.

    Specific Aims:

    Provide only the specific aims of the parent UL1.    

    Research Strategy:   

    Provide only the abstract of the parent UL1.

    Letters of Support:

    Include all Letters of Support in the Project Component.

    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, with the following modification:

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

    Appendix:

    Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.   

    PHS Human Subjects and Clinical Trials Information (Overall)

    When involving human subjects research, clinical research, and/or NIH-defined clinical trials 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, there must be at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record within the application. The study record(s) must be included in the component(s) where the work is being done, unless the same study spans multiple components. To avoid the creation of duplicate study records, a single study record with sufficient information for all involved components must be included in the Overall component when the same study spans multiple components.   

    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 (Overall)

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

    Project

    When preparing your application, use Component Type ‘Project.’

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

    SF424 (R&R) Cover (Project)

    Complete only the following fields:

    • Applicant Information
    • Type of Applicant (optional)
    • Descriptive Title of Applicant’s Project
    • Proposed Project Start/Ending Dates
    PHS 398 Cover Page Supplement (Project)

    Enter Human Embryonic Stem Cells in each relevant component.

    Research & Related Other Project Information (Project)

    Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.

    Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question.

    Project Narrative:  Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

    Project /Performance Site Location(s) (Project)

    List all performance sites that apply to the specific component.

    Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

    Research & Related Senior/Key Person Profile (Project)
    • In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Project Lead’ and provide a valid eRA Commons ID in the Credential field.
    • In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
    • Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
    • If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.   
    Budget (Project)

    Budget forms appropriate for the specific component will be included in the application package.

    Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

    PHS 398 Research Plan (Project)

    Introduction to Application: For Revision applications, an Introduction to Application is allowed for each component.

    Specific Aims:

    Briefly state the specific aims of the project indicating how the project will demonstrate, and/or disseminate, and/or implement a highly innovative and impactful translational science project that will address the goals of the CTSA Program and are beyond the original scope of the approved parent award.     

    Research Strategy:  

    Addressing a systemic barrier in clinical and translational science: 

    State which one or more of the CTSA Program Strategic Goals the supplement project addresses. Describe the translational science nature of the capability and how it addresses one or more of the CTSA Program Strategic Goals.  Note that NCATS describes translational science as understanding the scientific and operational principles underlying each step of the translational process in order to enable improvement.  See: https://ncats.nih.gov/translation/spectrum   

    Evidence that the proposed capability is ready for use and dissemination: 

    Provide evidence that the proposed capability has been tested/validated and led to a measurable impact at the local hub in an area of translational science that addresses one or more of the CTSA Program Strategic Goals. 

    Audience and partner identification:

    Provide a description of the needs of the audience and/or partner who will utilize and/or adopt the capability.  Provide a rationale why the capability has the likelihood to be impactful for the audience and/or partners.  Provide a description of how, once demonstrated and/or disseminated and/or implemented, the capability has a high likelihood of having a sustained impact on translational science. 

    Capability Dissemination and Implementation Plan: 

    A dissemination and implementation plan must be described and include a timeline, milestones and deliverables. Wherever possible, the approaches to dissemination and implementation should build knowledge both on the overall effectiveness of the approach, as well as "how and why" they work.  Describe a plan for dissemination of the results (resources, tools, interventions, etc.) of the project to the CTSA Program, and more broadly to the translational science community.

    Evaluation and Sustainability Plan: 

    Milestones and deliverables should be framed in terms of what would be considered a successful outcome for the project.  The project must provide a detailed plan for sustainability after the funding period of the supplement ends.  Identify measurements to assess success of the dissemination and implementation plan.  Metrics should be selected to ensure that enhanced capabilities of the receiving CTSA Program hub can be measured.  Pre- and post- assessments of the dissemination and implementation of the capability are recommended to demonstrate the value of its uptake, thereby providing evidence for subsequent stakeholders in deciding whether to implement the capability.

    Program Director/Principal Investigator:

    The PD/PI or other designated senior/key personnel that is contributing to the project must have demonstrated expertise in the proposed capability. 

    Letters of Support:

    To document agreement of the collaborations and intent to adopt the capability at the CTSA Program hub, each collaborating investigator is required to include a letter of support.  If the collaborating investigator is not the PD/PI of the collaboratory CTSA Program hub UL1, a letter from the PD/PI of the co-located or affiliated CTSA Program hub must be included.  For multiple investigators from the same CTSA Program hub, one letter of support from the CTSA Program contact PD/PI is sufficient. Where relevant, include letters of support or other documentation of partnerships or collaborative effort with the private sector (e.g., patient groups and/or industry), subcontractors, consultants, and/or other providers of personnel and facilities. Letters of support must detail how the CTSA Program hub(s) will provide support to the project (e.g. resources and assistance in dissemination of the outcomes of the project across the CTSA Program and possibly beyond).  Letters may provide assurance of a smooth execution of the project at all partnering institutions via Memorandum(s) of Understanding, contract agreements, reliance on a single IRB, etc.

    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, with the following modification:

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

    Appendix:

    Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.   

    PHS Human Subjects and Clinical Trials Information (Project)

    When involving human subjects research, clinical research, and/or NIH-defined clinical trials 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 a 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.

    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) using ASSIST or other electronic submission systems. 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.

    For information on how your application will be automatically assembled for review and funding consideration after submission go to: http://grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multi-project_Application_Image_Assembly.pdf.

    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) and component Project Leads must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

    The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management (SAM). 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.

    In addition, for applications involving clinical trials: 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:

    Does the project address a current or emerging area of unmet need in clinical and translational science?

    Does the project address an opportunity that can systematically improve clinical and translational science?

    Does the project contribute to advancing one or more of the CTSA Program Strategic Goals?

    If the project succeeds, will it have a transformative effect on the same aspect of clinical and translational science?

    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:

    Do the PD(s)/PI(s) have appropriate expertise in the developed resource/capability and have they demonstrated their ability to successfully disseminate and/or implement novel resources/capabilities at more than one institution?

    Do the letters of support provide assurance of the collaboration and the intent to adopt the capability at the partnering CTSA Program hub(s)?

    Do the letters of support provide assurance to support the project?

    Are letters of support included from the private sector (e.g., patient groups and/or industry), subcontractors, consultants, and/or other providers of personnel and facilities that provide details about their involvement in the project?

    If applicable, do the letters of support provide assurance of a smooth execution of the project at all partnering institutions via Memorandum of Understanding, contract agreements, reliance on a single IRB, etc.?

    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:

    Does the application propose the demonstration, and/or dissemination, and/or implementation of novel concepts, methodologies, approaches, interventions, etc. that open new opportunities in translational science?  

    Does the application address emerging areas?

    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 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:

    Is there satisfactory evidence that the proposed capability is sufficiently mature and ready for dissemination and implementation by other hubs?

    Are the audience and/or partner(s) appropriate for the project?

    Is the capability dissemination and implementation plan approach rigorous?

    Is the plan for disseminating the results of this project adequately described and reasonable?

    Are the project timelines, milestones and deliverables well-described and realistic; can the project be completed within the proposed timeframe?

    Is the evaluation and sustainability plan adequate to assess and measure the success and sustainability beyond the award period of the proposed project?

    Is the overall plan for sustainability after completion of the funding period adequate? 

    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:

    Are the resources and capabilities well integrated between the lead institution and its proposed partners?

    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.

     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

    Not Applicable

    Renewals

    Not Applicable

    Revisions

    For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

    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) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genomic Data Sharing Plan .

    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:

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

    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 NCATS Advisory Council. 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.  
    • Policies consistent with goals for resource, data sharing, and sharing of software.
    • Programmatic priorities, including but not limited to geographic distribution of CTSA Program Hubs and access to special populations.
    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 grantee’s business official.

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

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

    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: Grantee 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 awardee 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, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

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

    For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-individuals/section-1557/index.html; and https://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html. 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. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

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

    Cooperative Agreement Terms and Conditions of Award

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

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

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

    • Determining approaches, designing, implementing, and setting milestones for advancing translational and clinical research and training
    • Ensuring all participating institutions are fully integrated into the CTSA Program Hub
    • PD(s)/PI(s) has ultimate responsibility for implementing the activities at the CTSA Program Hub
    • Management, implementation, and tracking of the pilot project program
    • Ensuring informatics coordination and data exchange to facilitate translational research, compatibility of research systems with broadly accepted content and technical standards including those adopted by the Department of Health and Human Services for health care and public health operations, and compatibility with NIH Institute and Center endorsed common data elements
    • Implementation of a data security plan at all participating institutions that ensures the security of research data on all studies involving human subjects
    • Maintaining visibility of scientists and resources of CTSA institutions to facilitate collaboration
    • Implementation of a plan to create and maintain a broad culture of responsibility for safe and ethical conduct of human subjects research at all participating institutions, which ensures scientifically, and ethically flawed studies are not conducted, enrollment is tracked, and futile studies are closed in a timely manner, workflow for conduct of clinical and translational research is efficient, prompt analysis of results, and dissemination of those results
    • Implementation of tracking processes, metrics, and milestones including some metric common to the hubs participating in the CTSA Program
    • Provision of disease-agnostic support to translational and clinical researchers. The support must facilitate the participation of local investigators in national networks and multi-site studies, particularly those supported by NIH
    • Establishment of career development opportunities that encourage new investigators to work in clinical and translational science
    • Implementation of the proposed educational programs in collaboration with other hubs of the CTSA Program, and innovative research training and career development programs activities and assessment of their effectiveness
    • Effecting steps toward implementation of the agreed-on policies, procedures, best practices, or other measures established by NCATS
    • Provision of information to the NIH Project Collaborator concerning progress
    • Support of CTSA network activities

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

    The NIH Project Collaborators (PC) will be responsible for:

    • Enforcement of general statutory, regulatory, or policy requirements
    • Approval of awardee plans prior to award and review of performance after completion
    • Evaluation of progress by reviews of technical or fiscal reports, by program visits, or with external consultants, to determine that performance is consistent with objectives, terms and conditions of the award
    • Provision of technical assistance requested by awardees, or correcting programmatic or financial deficiencies in awardee performance
    • Cooperation or coordination with, or assistance to, awardees in performing project activities, e.g., coordination of research networks; coordinating access to NIH supported research resources; identifying other researchers/resources for the projects
    • Participation on steering and operations committees as a non-voting member or in other functions responsible for helping to guide the course of long-term projects or activities; e.g., annual meetings
    • Provision of a broad overview of the value provided by the awardee as measured by its achievement of its stated aims, the significance of its innovations and deliverables, and its metrics for application of its strengths to the transformation of clinical and translational research within its hub
    • Assessment of the awardee’s overall participation in and contributions to the CTSA Network and its support for development and implementation of best practices, policies, and procedures
    • Provision of scientific and technical discussions with awardees, facilitate or expedite interactions among awardees, and/or identify and facilitate access to resources, for examples, organizing and holding meetings with investigators
    • Participation in monthly calls with key CTSA Program hub leadership to discuss ongoing activities, provide input on initiatives, review Common Metrics and discuss strategic management.

    The Project Collaborator will be named as the Program Official in the Notice of Award.

    Areas of Joint Responsibility include:

    None; all responsibilities are divided between awardees and NIH staff as described above.

    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 awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

    3. Reporting

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

    A final 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.

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

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

    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)

    Pablo Cure, MD., MPH.
    National Center for Advancing Translational Sciences (NCATS)
    Telephone: 301-827-2014
    Email: pablo.cure@nih.gov

    Peer Review Contact(s)

    Victor H. Henriquez, Ph.D.
    National Center for Advancing Translational Sciences (NCATS)
    Telephone: 301-435-0813
    Email: victor.henriquez@nih.gov

    Financial/Grants Management Contact(s)

    Irene Haas
    National Center for Advancing Translational Sciences (NCATS)
    Telephone: 301-435-0836
    Email: irene.haas@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 42 CFR Part 52 and 45 CFR Part 75.    

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