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: Clinical and Translational Science Awards (CTSA) Consortium-Wide Centers: Resources for Rapid Demonstration and Dissemination (U24 Clinical Trials Not Allowed)
Activity Code

U24 Resource-Related Research Projects – Cooperative Agreements

Announcement Type
New
Related Notices

  • April 14, 2021 - Notice of Special Interest (NOSI): Topic Areas for PAR-21-203. See Notice NOT-TR-21-025.

Funding Opportunity Announcement (FOA) Number
PAR-21-203
Companion Funding Opportunity
None
Assistance Listing Number(s)
93.350
Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) invites applications for Clinical and Translational Science Awards (CTSA) Program consortium-wide resource centers that will rapidly demonstrate and disseminate to the wider consortium innovative resources (to include capabilities) that have established impact at a local or national level. Applications for CTSA consortium-wide centers are expected to rapidly demonstrate and disseminate resources to advance clinical and translational science efforts.

Only applications submitted in response to a Notice of Special Interest (NOSI) published by NCATS will be allowed to apply to this FOA.

Key Dates

Posted Date
April 06, 2021
Open Date (Earliest Submission Date)
May 21, 2021
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
June 21, 2021 Not Applicable Not Applicable October 2021 January 2022 April 2022
June 21, 2022 Not Applicable Not Applicable October 2022 January 2023 April 2023
June 21, 2023 Not Applicable Not Applicable October 2023 January 2024 April 2024

All applications are due by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on the listed date(s).

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
June 22, 2023
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

This Funding Opportunity Announcement (FOA) invites applications for Clinical and Translational Science Awards (CTSA) Program consortium-wide resource centers that will rapidly demonstrate and disseminate to the wider consortium innovative resources (to include capabilities) that have established impact at a local or national level. Applications for CTSA consortium-wide centers are expected to advance clinical and translational science efforts by facilitating scientific collaborations, scaling efficacious studies, and distributing common research resources throughout the network of CTSA institutions.

Only applications submitted in response to a Notice of Special Interest (NOSI) published by NCATS will be allowed to apply to this FOA.

Background

The CTSA Program is a national, collaborative consortium focused on bringing more treatments to more patients more quickly by: (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. Applications for CTSA consortium-wide resource centers are expected to rapidly demonstrate and disseminate resources to advance these CTS efforts across the entire network of CTSA institutions.

The process to develop and implement clinical interventions and other research endeavors that demonstrably improve human health is currently complex, iterative, and, at times, inefficient. As such, new insights and innovative approaches are needed 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.

Through the CTSA Program, NCATS supports an integrated research and training environment for CTS, 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 research 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 CTS and operations, the nature of which will build on local institutional strengths and in particular geographic/demographic needs. 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 at various levels, e.g., locally, regionally, and nationally.

Many of the developed 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 the consortium. This FOA solicits applications for research centers to support the acceleration and rapid dissemination of evidenced-based, innovative resources and capabilities across the entire CTSA consortium.

Specific Objectives

This funding opportunity will support research centers focused on broadly scaling the demonstration and dissemination of translational science resources (to include capabilities) in specific areas that have been tested and validated at one or more hubs. Assets may include, but are not limited to, existing and/or novel methods, processes, approaches, interventions, communications, tools, technologies, software, applications and training that improve and accelerate the translational research process. All projects require a detailed needs assessment, as well as dissemination, evaluation, management and sustainability plans that will inform subsequent dissemination. Projects should provide evidence that the proposed asset is ready for use and dissemination. It is expected that the support for the resource center will help catalyze the sharing, adoption and/or expansion of innovations, that may be developed at a specific hub(s) or the hub’s partners or collaborators, to additional CTSA Program hubs and beyond. Projects should address novel and/or emerging approaches in areas of need with the overall goal of improving efficiencies in clinical and translational science. In doing so, this initiative will further NCATS’ vision of the CTSA Program as an integrated and collaborative national network that comprises of hubs that work together to improve the translational science process and get more evidenced-based treatments, interventions, and/or programs to more patients more quickly.

Highly impactful resource centers are expected to demonstrate and disseminate assets developed at one or more hubs or institution that:

    • Builds 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).
    • Could be expanded and made available to multiple users/communities across the CTSA Program and possibly beyond.

NCATS will only accept applications addressing specific topics as defined in a Notice of Special Interest (NOSI) released annually. Applicants should consult the current NCATS NOSI listed in the “Related Notices” section above for responsive topics. Applications that do not address a specific topic in the current NOSI will be considered non-responsive and will not be reviewed.

Non-Responsive Applications

The following will be considered non-responsive. Non-responsive applications will not be reviewed.

    • Applications that do not propose to disseminate the resource and/or capability across the CTSA consortium.

Prior Consultation with NCATS

Consultation with NCATS staff at least 2 months prior to the application due date is strongly encouraged for submission of the Resource-Related Research Projects--Cooperative Agreement (U24) application. If requested, NCATS staff will consider whether the proposed U24 meets the goals and mission of the Institute; whether it addresses one or more high priority research areas; and whether the application is best fit to the U24 activity code.

NCATS staff will not evaluate the technical and scientific merit of the proposed project; technical and scientific merit will be determined during peer review using the review criteria indicated in this FOA. During the consultation phase, if the proposed project does not meet NCATS’ programmatic needs or is not appropriate for this FOA, applicants will be strongly encouraged to consider other Funding Opportunities.

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

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?

Not Allowed: Only accepting applications that do not propose clinical trials.

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.

NCATS intends to fund 1-3 awards in FY2022.

Award Budget

Application budgets are limited to $3,000,000 per year direct cost and must reflect the actual needs of the proposed project.

Award Project Period

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

An application must be submitted by an institution that is a direct recipient of a CTSA Program hub or an institution listed as a partnering institution in a currently funded CTSA Program hub. 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).

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.
  • 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 or contact PD/PI must be employed by a direct recipient of funding from a currently funded CTSA Program hub institution or a partnering institution as defined above in Eligible Organizations. Investigators who are not employed by a direct recipient of funding from a CTSA Program hub institution or partnering institution but who wish to bring an innovative project to the CTSA Program, can co-direct a project in partnership with a contact PD/PI who is employed by a currently funded CTSA Program hub institution or partnering institution using the multiple PD/PI option.

The PD/PI should be an established investigator in clinical and translational science field and capable of providing both administrative and scientific leadership to the demonstration and dissemination of the proposed activities. The PD(s)/PI(s) should have a strong track record coordinating and administrating large and collaborative networks, demonstrated experience in effectively communicating, messaging and disseminating various resources and information to stakeholders and to the broader scientific community. The PD(s)/PI(s) are each expected to commit at least two person months effort per year and preferably three to six person months per year effort to the award.

Applicants should document the PD/PI's (and, as relevant, additional senior/key personnel's) experience in 1) fulfilling the mission of the CTSA Program or another comparable program, 2) coordinating and administrating large and collaborative networks, 3) expertise and experience in the area of the described resource and/or capability, and 4) effectively communicating, messaging and successfully disseminating various resources and information to stakeholders and to the broader scientific community.

See required Letters of Support (Section IV).

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).

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&##38;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
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.

SF424(R&R) Senior/Key Person Profile

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

Biosketches from External Scientific Consultants should be included in the application if the consultant has accepted the invitation to be an External Scientific Consultant.

R&R Budget

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

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:

Specific Aims:

Briefly state the specific aims of the center indicating how it will demonstrate and disseminate highly innovative, collaborative and impactful translational science resources (to include capabilities) that will address the goals of the CTSA Program.

Research Strategy:

Program Director/Principal Investigator:

Without duplicating information in the biosketches, describe how the PD/PI and other designated senior/key personnel that are contributing to the project must have demonstrated expertise in the proposed resource and/or capability.

Addressing a systemic barrier in clinical and translational science:

State which one or more of the CTSA Program Strategic Goals the project addresses. Describe the translational science nature of the resource 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

Needs Assessment:

Provide a needs assessment that includes a review of the landscape and gaps of existing resources (including research capabilities) across the CTSA consortium. This must include an analysis of the existing utilization and adoption. Provide a rationale why the resource has the likelihood to be impactful for the CTSA consortium. Provide a description of how, once demonstrated and disseminated the resource and/or capability has a high likelihood of having a sustained impact on translational science.

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

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

Strategy for generating evidence for resources that are not evidence-based:

If applicable, for innovations that have preliminary evidence for advancing clinical research / clinical trials, provide a plan to validate those resources as part of the implementation plan. This could include testing methods to rapidly identify and enroll participants for clinical trials, methods to reach and enroll diverse and underserved populations in clinical research, and best methods to include the patient’s perspective in a clinical research study. If the resources will be used to implement clinical trials, provide a plan to evaluate if the resources enhanced the implementation of the resultant trials, such as accelerating site activation or reducing time for regulatory approvals.

Dissemination Plan:

A dissemination plan must be described and include a timeline, milestones and deliverables. Wherever possible, the approaches to dissemination 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 across the CTSA consortium, and more broadly to the translational science community. As appropriate for information technology required for the dissemination of resources/capabilities, preference will be given to applications that specify plans for integrating technology with any of the major public cloud providers via NCATS’ Federated Authorization Service.

Evaluation Plan:

Milestones and deliverables must be included and framed in terms of what would be considered a successful outcome for the resource center. Identify measurements to assess success of the dissemination plan. Metrics should be selected to ensure that enhanced resources of the receiving CTSA consortium hubs can be measured, including assessing the impact of the consortium-wide dissemination in translational science. Pre- and post- assessments of the dissemination of the resource are expected to demonstrate the value of its uptake, thereby providing evidence for subsequent stakeholders in deciding whether to implement the resource.

Management Plan:

Describe the plans for management and integration of the resource center with other activities within the CTSA Program, including a communication plan for the CTSA consortium. Describe who will oversee day-to-day activities (e.g., a project manager if not the PD/PI) and how the management structure will support achievement of the proposed goals and milestones. Useful elements of this description include the organization of the proposed center; its management structure; personnel and leadership structure; and oversight mechanisms for evaluating progress towards milestones. The plan should also describe how the stated collaborations will be managed.

Sustainability Plan:

The center must provide a detailed plan for sustainability after the funding period ends. Applicants are expected to seek additional resources to maintain their operations and continue to have an impact after NIH funding ends. Plans should indicate other sources of support for program sustainability, and include descriptions of all institutional support, financial and collaborative arrangements, and/or agreements for payment for services. Appropriate documentation should be included in the application. Provide any other relevant information about the applicant’s approach for self-sustaining infrastructure and operations.

External Scientific Consultants:

Applicants must provide a plan for the appointment of External Scientific Consultants to provide advice and comments to the resource center about the activities outlined in this FOA, including progress made towards the overall goals of the FOA, and any changes in scope or governance that might help make the resource center more effective and useful. The composition, roles, responsibilities, and desired expertise of the consultants, frequency of meetings, and other relevant information should be included. Describe how the External Scientific Consultants will evaluate the overall effectiveness of the activities, including the stated expected impact of its activities. Proposed External Scientific Consultants should be named in the application if they have been invited to participate at the time the application is submitted and agreed to participate as an External Scientific Consultant.

NOTE: Applications that do not include the required Dissemination, Evaluation, Management, and/or Sustainability Plans, or do not include a plan to appoint External Scientific Consultants will be considered incomplete and will not be reviewed.

Letters of Support:

Provide all appropriate letters of support, including any letters necessary to demonstrate the support of collaborators. Each collaborating investigator is required to include a letter of support from the PD/PI of the CTSA Program hub with which they are associated. 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 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 from External Scientific Consultants should be included in the application if the consultant has accepted the invitation to be an External Scientific Consultant.

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.

The following modifications also apply:

This FOA requires a separate Sharing Plan for the Resource.

It is NIH policy that the results and accomplishments of the activities that it funds should be made available to the public. PD/PIs and recipient organizations are expected to make the results and accomplishments of their activities available to the research community and the public at large. Investigators conducting biomedical research frequently develop unique research resources. NIH considers the sharing of such unique research resources (also called research tools) an important means to enhance the value of NIH-sponsored research. Restricting the availability of unique resources can impede the advancement of further research. At the same time, NIH recognizes the rights of recipients to elect and retain title to subject inventions developed with federal funding pursuant to the Bayh-Dole Act. See the Office of Extramural Research, Division of Extramural Inventions & Technology Resources (DEITR), Intellectual Property Policy page: http://grants.nih.gov/grants/intell-property.htm.

To provide further clarification of the NIH policy on disseminating unique research resources, NIH published Principles and Guidelines for Recipients of NIH Research Grants and Contracts on Obtaining and Disseminating Biomedical Research Resources (64 FR 72090, December 23, 1999; https://grants.nih.gov/grants/intell-property_64FR72090.pdf). This document will assist recipients in determining reasonable terms and conditions for disseminating and acquiring research tools.

For the purposes of this FOA, the resource/capability can be considered a research tool as described in the Principles and Guidelines for Recipients of NIH Research Grants and Contracts on Obtaining and Disseminating Biomedical Research Resources (64 FR 72090, December 23, 1999; https://grants.nih.gov/grants/intell-property_64FR72090.pdf). For the purposes of this FOA the research tool may include software, algorithms and code.

As appropriate for the resource/capability, the following services must be incorporated into the plan:

NCATS Information Resources Technology Branch (ITRB) will provide access to various public cloud services, and high-performance computing services for the needs of the awardees. This enables the awardees 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 awardees to gain a self-service capability. NCATS ITRB will provide the following:

  • Infrastructure as a Service (IaaS) 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 awardees systems and applications, various Common Cloud Engineering and Support Services.

IaaS Services

  • NCATS ITRB will provide the awardee with a cloud instance on any of the following public cloud service providers: Amazon Web Services, Microsoft Azure or Google Cloud Platform. Access to the awardees cloud instance would be managed using NCATS' Federated Authorization System and the awardees would have rights to allowable services provided by the Cloud Service Provider.
  • Federated Authorization Services SaaS.
  • NCATS ITRB will provide access to NCATS' Federated Authorization Service. The awardee will use NCATS' Authorization Service for federated access to any of their systems and applications.
  • Cloud Engineering Support.
  • NCATS IRTB will provide access to and administrative support for various common cloud services including configuration, patching, backups, and user account management. These services include, but are not limited to: Automated Configuration Management Services; Continuous Integration Services; Automated Deployment Services; Code Analysis Services; Log Aggregation and Analysis; Usage and Performance Monitoring Services; Aggregated Search Services; Cache management services; and Message Queue and Notification services.

Cloud based High Performance Computing

  • NCATS ITRB can also provide a cloud based elastic high performance computing (HPC) service designed to automate and scale, giving the scientists the ability to model and deploy their HPC applications in a cloud that can provide the scale and performance needed. The cloud HPC provides resources without undue access restrictions, while addressing the security concerns surrounding cloud deployments. The cloud HPC solution addresses use cases that deal with various storage, hypervisor and network services. The cloud HPC offers higher utilization and operational savings while providing a high speed, secure and federated access.
  • NCATS will coordinate and support efforts, in collaboration with representatives of the CTSA program, to develop and monitor Good Data Practices (GDP) of clinical and research data and will assist in facilitating the use of Common Data Elements (CDE).

Specifically, under this cooperative agreement, NCATS will support (financially and administratively) access to various public cloud services, and high-performance computing services for the needs of the awardees software that will be physically sitting on the NCATS cloud instance. As such, NCATS will maintain access and involvement with these software platforms as certain Health and Human Services (HHS) and NIH Information Technology (IT) security and privacy [including Public Health information (PHI) and Health Insurance Portability and Accountability Act (HIPAA)] requirements must be adhered to by the Center.

NCATS is responsible for CTSA program data security and compliance but is using systems that are purchased or built by others, such as third-party vendors, NCATS and its contractors.

  • NCATS would support that our Vendors have appropriate Business Associates Agreement with the CTSA program due to the cooperative agreement aspect of the cooperative agreement and because (1) these software systems currently reside on the NCATS Amazon Web Services (AWS) Cloud and (2) NCATS has a contractual relationship with the vendor.
  • Any system admin privileges and roles are under control of NCATS however, change control procedures will be worked out between NCATS ITRB with CTSA program points of contact.

If the resource that is proposed to be utilized by the CTSA consortium is already developed and an appropriate sharing plan is not in place (licensing, continued support of the research tool, etc.), the Sharing Plan must detail the transition of the resource to the NCATS cloud. The transition must describe what is needed for the project and assurance that the awardee will utilize NCATS cloud Computing Services and Engineering Support provisioned by the ITRB. Transition must occur within the first six months of the award. The sharing plan must provide details and a timeline for utilization, commercialization, and public availability of the resource at the end of the award. It is expected that NCATS support during the award using ITRB services will result in cost savings for the awardee and the NIH, facilitate and support data that will demonstrate the effectiveness and utility of the resource at a larger scale across the CTSA consortium, and provide sufficient time to develop a plan for continued independent support and/or commercialization. With respect to any invention in which the grantee elects rights, NIH shall have a nonexclusive, nontransferable, irrevocable, paid-up license to practice or have practiced for on behalf of the United States any subject invention throughout the world for government purposes (37 CFR 401.14.6.b).

If the applicant proposes to utilize research resource separately from the NCATS Cloud Computing Services and Engineering Support provisioned by the ITRB, applicants must specify how their resource dissemination plan aligns with the Sharing Biomedical Research Resource principles outlined by NIH (https://grants.nih.gov/grants/intell-property_64FR72090.pdf) and provide a sharing plan specifying the details of how relevant resources will transition to NCATS at the end of the award. Please note that if NCATS determines that separate research resources do not meet the purpose and goals of this funding announcement, such requests may be denied.

Applicants are strongly encouraged to discuss the project’s needs with Program Staff prior to submission.

Program staff are responsible for overseeing resource sharing policies and for assessing the appropriateness and adequacy of any proposed resource sharing plans. Program staff may negotiate modifications to these plans prior to funding and these modifications will be incorporated into the terms and conditions of the award.

Appendix:
Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
  • No publications or other material, with the exception of blank questionnaires or blank surveys, may be included in the Appendix.
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 field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.

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

See more tips for avoiding common errors.

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

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.

For this particular announcement, note the following:

This FOA is intended to support CTSA consortium-wide resource centers that will rapidly demonstrate and disseminate to the wider consortium innovative resources (to include capabilities) that have established impact at a local or national level. Applications for CTSA consortium-wide resource centers are expected to rapidly demonstrate and disseminate resources to advance clinical and translational science efforts.

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 proposed Center address the needs of the research consortium that it will serve? Is the scope of activities proposed for the Center appropriate to meet those needs? Will successful completion of the aims bring unique advantages or capabilities to the research consortium?

Specific to this FOA:

To what extent does the project address a current or emerging area of need in clinical and translational science?

To what extent does the project contribute to advancing one or more of the CTSA Program Strategic Goals?

To what extent does the application propose a research center to support the acceleration and rapid dissemination of evidenced-based, innovative resources and capabilities across the entire CTSA consortium?

Is there a satisfactory needs assessment for the resource and/or capability to support the likelihood of the project having a sustained impact on translational science?

Investigator(s)

Are the PD(s)/PI(s) and other personnel well suited to their roles in the Center? Do they have appropriate experience and training, and have they demonstrated experience and an ongoing record of accomplishments in managing clinical and translational research? Do the investigators demonstrate significant experience with coordinating collaborative research? If the Center is multi-PD/PI, do the investigators have complementary and integrated expertise and skills; are their leadership approach, governance, plans for conflict resolution, and organizational structure appropriate for the Center? Does the applicant have experience overseeing selection and management of subawards, if needed?

Specific to this FOA:

Do the PD(s)/PI(s) have appropriate expertise in facilitating the development and sharing of resource and/or capability, and do they provide sufficient evidence of their ability to successfully demonstrate and disseminate novel resources at more than one institution?

Do the PD(s)/PI(s) have sufficient time and committed sufficient effort to accomplish the goals of the Center?

Do the letters of support provide assurance that the collaborators will support the project?

Is the plan to recruit External Scientific Consultants with appropriate expertise suitable?

Innovation

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

Specific to this FOA:

To what extent does the application propose the demonstration and dissemination of novel methods, processes, approaches, interventions, communications, tools, technologies, software, applications and/or skills training that improve the translational science process across multiple institutions?

Approach

Are the overall strategy, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of the research consortium the Center will serve? Will the investigators promote strategies to ensure a robust and unbiased scientific approach across the consortium, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the consortium is in the early stages of operation, does the proposed strategy adequately establish feasibility and manage the risks associated with the activities of the consortium? Are an appropriate plan for work-flow and a well-established timeline proposed? Have the investigators presented adequate plans to ensure consideration of relevant biological variables, such as sex, for studies of 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 the proposed research center strategy (to determine whether a resource and/or capability is mature) sufficiently detailed and does it demonstrate promise in disseminating validated resources across the CTSA consortium?

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

Is the evaluation plan adequate to assess and measure the success and impact of the proposed project? Are the metrics reasonable and do they provide a clear assessment of consortium-wide impact? Are the project timelines, milestones and deliverables well-described and realistic; can the project be completed within the proposed timeframe?

Is the approach described in the management plan sufficient to ensure success?

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

Is the Sharing Plan for the Resource sufficient for the proposed resource center?

Environment

Will the institutional environment in which the Center will operate contribute to the probability of success in facilitating the research consortium it serves? Are the institutional support, equipment and other physical resources available to the investigators adequate for the Center proposed? Will the Center benefit from unique features of the institutional environment, infrastructure, or personnel? Are resources available within the scientific environment to support electronic information handling?

Specific to this FOA:

To what extent is the environment optimal for a timely and complete integration of the proposed resources throughout the CTSA consortium?

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.

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

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 are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3)  Genomic Data Sharing Plan (GDS).

Authentication of Key Biological and/or Chemical Resources:

For Centerts 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 submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:

  • Scientific and technical merit of the proposed project as determined by scientific peer review.
  • Availability of funds.
  • Relevance of the proposed project to program priorities, including but not limited to geographic distribution of CTSA Program Hubs and access to special populations.
  • Policies consistent with goals for resource, data sharing, and sharing of software.
  • As appropriate for information technology required for the dissemination of resources/capabilities, preference will be given to applications that specify plans for integrating technology with any of the major public cloud providers via NCATS’ Federated Authorization Service.

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.

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.

Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that 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.

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. 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 laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex. This includes ensuring programs are accessible to persons with limited English proficiency. 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 http://www.hhs.gov/ocr/civilrights/understanding/section1557/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 75.205 “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 recipients is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the 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:

  • Overseeing all operations of the resource center according to the plan outlined in the grant application, with modification as needed per NCATS including, but not limited to, collaboration with other CTSA consortium partners under standard governance, to safeguarding of human subjects, their data, and their privacy.
  • Defining research objectives and approaches and for providing overall scientific and administrative leadership for the Research Project. This includes responsibility for the research objectives and scope outlined in the Funding Opportunity.
  • Collaborating with other CTSA resources centers in developing joint Standard Operating Procedures, as needed, subject to NCATS review.
  • Planning, conducting, analyzing, and publishing results, interpretations, and conclusion of relevant project activities.
  • Placing all relevant activity and project materials into the public domain. Recipients are expected to publish and publicly disseminate results, data, and other products of the project, concordant with governance policies and protocols. Publications and oral presentations of work performed under this agreement will require appropriate acknowledgment of support by the NCATS/NIH.
  • Recipient(s) will agree to accept close coordination, cooperation, and participation of NCATS Program Staff in those aspects of scientific and technical management of the project as described under the responsibilities of the NCATS Project Scientist and NCATS Program Official.
  • Recipient(s) will agree to the governance of the CTSA Program Consortium.
  • Presentation of semi-annual reports to the NCATS CTSA Program Steering Committee on the current and planned activities.
  • Obtaining prior written approval of the NCATS Grants Management Specialist in consultation with the NCATS Program Officer for any change in any of the key personnel identified in the Notice of Grant Award.

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

The NIH Project Scientist (PS) will be responsible for:

  • Providing substantial programmatic involvement that is above and beyond the normal stewardship role in awards.
  • Providing cooperation or coordination with, or assistance to, 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.
  • Participating 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.
  • Assessing the recipient’s overall participation in and contributions to the CTSA consortium and its support for development and implementation of best practices, policies, and procedures.
  • Serving as a point of contact for investigators with the NIH.
  • Overseeing the activities of any shared NCATS/CTSA infrastructure, along with the other entities delineated above, to ensure that activities and services are properly conducted and completed in a timely fashion.
  • Providing advice and guidance to ensure that any shared NCATS/CTSA infrastructure runs in accordance with NIH policies and procedures and is consistent with the mission of the NIH to improve public health.
  • Disseminating information from the Center and communicating with Center leadership to ensure that any shared NCATS/CTSA infrastructure operates smoothly.
  • Providing assistance with the selection of contractors or sub-recipients under the assistance award, and in the selection of key project personnel other than principal investigators of projects or sub-projects.
  • Coordinating interactions with relevant programs; provide expertise and overall knowledge of NIH-sponsored programs and other projects to facilitate collaboration (e.g., coordinating access to NIH supported research resources, identifying other researchers/resources for the projects).
  • Coordinating interactions with relevant groups as necessary (NCATS CTSA Steering Committee, External Scientific Consultants, NIH institutes, governmental agencies, research organizations, research and disease foundations, the biotechnology or pharmaceutical industry, and other external stakeholders).
  • Providing for an option to halt a project activity if technical performance requirements are not met, if program objectives have already been met, or if program objectives change.
  • Participating in the presentation of results, including publications from the project.
  • Participating in the development semi-annual reports to the NCATS CTSA Steering Committee on current and planned activities.
  • Assessing the recipient’s overall participation in and contributions to the CTSA Program consortium and its support for development and implementation of the project activities described under this award.

The Program Official will:

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

Areas of Joint Responsibility include:

  • Developing milestones for the described activities. Per the Funding Opportunity, areas of joint responsibility are identified in the approved milestones. Program staff may negotiate with the applicant institution modifications to the Sharing Plan for the Resource prior to funding and these agreed upon modifications will be incorporated into the terms and conditions of the award.
  • Participating in recurring meetings (no less than monthly) by teleconference, or more frequently as needed, to discuss priorities, progress, obstacles, solutions, and any other related issues and/or activities related to ongoing and planned activities.

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)

Audie Atienza, PhD
National Center for Advancing Translational Sciences (NCATS)
Telephone: 301-435-0198
Email: Audie.Atienza@nih.gov

Peer Review Contact(s)

Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).

Financial/Grants Management Contact(s)

Stacia Fleisher
National Center for Advancing Translational Sciences (NCATS)
Telephone: 301-435-0851
Email: stacia.fleisher@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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