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
Virtual Approaches Towards New Chemistries for Un-drugged Targets through A Specialized Platform for Innovative Research Exploration (ASPIRE) Collaborative Research Program (U18 Clinical Trials Not Allowed)
Activity Code

U18 Research Demonstration – Cooperative Agreements

Announcement Type

New

Related Notices

None

Funding Opportunity Announcement (FOA) Number
RFA-TR-21-002
Companion Funding Opportunity

RFA-TR-21-001 - New Chemistries for Un-drugged Targets through A Specialized Platform for Innovative Research Exploration (ASPIRE) Collaborative Research Program (UG3/UH3 Clinical Trials Not Allowed)

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

93.350

Funding Opportunity Purpose

The purpose of the ASPIRE Collaborative Research Program is to facilitate translational and clinical research between NCATS intramural scientists and the extramural community to develop approaches that will enhance our ability to discover and develop new chemistries designed towards previously undrugged biological targets (i.e., biological targets with no known drugs to modulate their function) across many human diseases and conditions. NCATS intramural scientists have established an integrated platform consisting of physical and virtual modules for automated synthetic chemistry, artificial intelligence (AI) and machine learning (ML), engineering, informatics, and biological testing. This FOA will support intramural - extramural collaborations to develop virtual modules that will enhance the platform’s capabilities (see companion FOA RFA-TR-21-001 for physical modules). The anticipated outcome includes identification, design, synthesis, and validation of new chemical entities as starting points for drug development of novel targets, and the expansion of chemical space available for drug screening.

Key Dates

Posted Date
December 10, 2020
Open Date (Earliest Submission Date)
June 08, 2021
Letter of Intent Due Date(s)

June 8, 2021

Application Due Date(s)

July 8, 2021

No late applications will be accepted for this Funding Opportunity Announcement.

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.

AIDS Application Due Date(s)

Not Applicable

 

 

Scientific Merit Review

October 2021

Advisory Council Review

January 2022

Earliest Start Date

April 2022

Expiration Date
July 09, 2021
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.

Table of Contents

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Purpose

This Funding Opportunity Announcement (FOA) aims to promote partnerships between NCATS intramural investigators (e.g., those conducting research within the labs and clinics of NCATS) and extramural investigators (e.g., those conducting research in labs and clinics outside of the NIH). Specifically, the FOA will provide support for extramural investigators to take advantage of the unique research opportunities available at the NCATS ASPIRE Laboratory, within the NCATS Division of Pre-clinical Innovation (DPI), and develop innovative ASPIRE modules that will facilitate identification of novel chemical entities targeted towards currently undrugged biological space. Funds from the National Institutes of Health (NIH) will be made available through an U18 cooperative agreement awards mechanism. While companion FOA RFA-TR-21-001 focuses on the development of physical modules, this FOA focuses on virtual, cloud-based modules to enhance the existing capabilities of NCATS ASPIRE modular infrastructure, initially established at NCATS ASPIRE Laboratory. Details about the NCATS ASPIRE Laboratory and current platform’s capabilities are provided at the laboratory’s site (ncats.nih.gov/aspire/about/intramural-laboratory). Virtual modules developed through this extramural-intramural collaboration will be incorporated into the NCATS ASPIRE platform to enhance the process of drug discovery and development and bring novel, safe and effective treatments to more patients more quickly, and at lower cost.

Background

The NCATS ASPIRE Program has the central goal of expanding the set of small-molecule chemical structures needed to modulate biological targets. Currently, progress on the vast number of possible chemical structures in drug-like chemical space (~1060), and the smaller but still substantial number of biological targets in human and pathogen biological space (~106), has been slow and incremental. Using today’s approaches to chemical synthesis, only ~3% of biological space is drugged and a further ~7% is tractable via small-molecule probes. In addition, the percentage of drug-like chemical space that has been synthesized is relatively small compared to the untapped potential. NCATS ASPIRE is a catalytic and transformative drug design and development program that aims to advance our ability to match undrugged biological targets to the corresponding drug-like chemical space and increase our arsenal of novel tools and technologies to fight human diseases.

As artificial intelligence (AI) and machine learning (ML) become increasingly important to the biomedical research community, NCATS ASPIRE leverages these advances in automated synthetic chemistry and high-throughput biology. The exploration of biologically active chemical space will be accelerated thereby enabling new avenues for translation and drug development. AI/ML will be used in searching the chemical space for compounds to bind to a biological target; searching both known and novel synthetic routes for producing the compounds; and using the biological assay results as training sets for further optimization of compound structure and function. AI/ML coupled to big data and cheminformatics will have tremendous potential to improve design of novel therapeutics and to provide safe and effective drugs to patients.

The long-term goal of the NCATS ASPIRE initiative is to expand the chemical space from which new and improved therapeutics can be drawn through the identification, synthesis, and validation of new chemical entities. The short-term goal is to sustain an innovative and collaborative eco-system where the intramural NCATS ASPIRE platform provides access to capabilities that are not readily available in extramural laboratories, while the extramural investigators provide complementary, as well as disease and disease-relevant assay expertise to jointly develop cutting-edge techniques for potential integration.

Leveraging Existing Research Resources:

This initiative will leverage the NCATS ASPIRE infrastructure built at NCATS ASPIRE Laboratory (ncats.nih.gov/aspire/about/intramural-laboratory) with the support of the NIH Helping to End Addiction Long-term Initiative (NIH HEAL Initiative) Applicants are required to utilize the expertise and infrastructure available at the NCATS. In addition, leveraging the resources and support from patient advocacy groups, private research foundations, academic institutions, for profit organizations and other government agencies and the NIH Intramural Program is also encouraged.

Pre-Application Consultation:

Applicants must consult with NCATS Extramural Program Staff early in the planning of an application. This early contact will provide an opportunity to discuss and clarify NIH policies and guidelines, including the scope of the project and intent of this FOA.

 Prospective applicants are required to discuss their proposed projects with the DPI Director of Compound Management and Automation and include in their application a letter of collaboration from the Scientific Director of NCATS/DPI that documents agreement to participate in the proposed collaboration. See Letters of Support and the Intramural Program contacts below.

See also Applicant Webinar information under Section IV.7 below ("Other Submission Requirements and Information").

NCATS ASPIRE Laboratory Capabilities

This FOA requires partnerships with intramural investigators at the NCATS ASPIRE Laboratory (ncats.nih.gov/aspire/about/intramural-laboratory). NCATS ASPIRE platform uses a modular approach including but not limited to reagent preparation and dispensing, reaction execution and workup, purification, and characterization of new drug candidates in a high-throughput manner and with AI/ML capabilities. The overall intent is to keep the capabilities of the platform as diverse and cutting edge as possible by partnering with extramural collaborators who are engaged in next generation research and who can bring the research to be further developed, validated and deployed on the platform. The role of the NCATS ASPIRE Laboratory will be to optimize these technologies such that they can be deployed at an industrial scale in order to meet the vision of developing, operating and maintaining a next generation translational discovery platform that will be accessible to a wide community of scientists.

Research Objectives and Scope

For this FOA, the focus is to expand the chemical space from which new and improved therapeutics can be drawn through the identification, synthesis, and validation of new chemical entities. Extramural investigators will collaborate with the NCATS ASPIRE Laboratory (ncats.nih.gov/aspire/about/intramural-laboratory) to develop a virtual, cloud environment-based module. The module will be validated by the NCTAS ASPIRE Laboratory and coupled to NCATS ASPIRE platform’s chemical synthesis and biological screening capabilities. The goal is to enhance the overall capabilities of the NCATS ASPIRE platform and, ultimately, open the platform to non-chemists who can formulate a molecular hypothesis and utilize the platform to translate their ideas into testable compounds.

Active engagement with open communication channels is expected between the extramural researchers and NCATS ASPIRE Laboratory. To promote collaborative efforts from the outset, the partnering intramural and extramural investigators must work jointly in developing the application for this FOA. Extramural collaborators will provide expertise relevant to the development of a virtual module of interest. Where applicable, this must include disease and disease-relevant biological assay development expertise. The role of NCATS ASPIRE Laboratory will be to provide additional expertise relevant to development of the module and how it will be integrated with the overall platform to address a scientific question posed by the investigator. Depending upon the type of a virtual module selected, the involvement of NCATS may vary, ranging from cloud computing, expertise in a biological target of interest, small molecule or biological synthesis, automation, informatics analysis, or other related computational, chemistry and biology disciplines.

NCATS is particularly interested in virtual modules that would:

  • Create a retrosynthetic analysis and reaction prediction platform and to integrate existing tools.
  • Create a pool of machine-readable protocols for reaction types based on literature mining.
  • Create a high-throughput synthesis compatible Electronic Laboratory Notebook (ELN).
  • Create a network of virtual instruments/equipment and create a scheduling system using message passing interface (MPI) or similar.
  • Simulate a "full reaction cycle" by:
    1. Submitting a target molecule
    2. Create an ELN page and propagate all the necessary info automatically
    3. Find synthetic route
    4. Translate to protocol(s)
    5. Schedule the necessary instruments/equipment
    6. Execute protocols
    7. Collection of simulated data into ELN
    8. Update AI/ML models based on experimental outcomes

Other virtual modules will also be considered.

The collaborations in this FOA will sustain an innovative and collaborative ecosystem. Specifically, this FOA is seeking collaborators with:

  • Strong computer science background with focus on graph network theory.
  • Strong software engineering expertise.
  • Expertise in Graph Convolutional Network (GCN) based deep learning.
  • Organic chemistry domain knowledge.
  • Expertise in Natural Language Processing (NLP).
  • If applicable, specific disease- and disease-relevant assay development expertise.

This FOA will use the U18 innovation award mechanism of funding. Applicants are expected to work on a virtual module of their choosing that will be required to meet the standards set by a functional specification that will be provided to applicant during the initial discussions with the NCATS ASPIRE Laboratory scientists, and will be included in the application. Applicants must adhere to these specifications to design, operate, test, and validate the functions of the virtual module.

U18 Milestones

All projects must be milestone-driven with clear go/no-go criteria that are quantifiable. Prior to funding an application, the Program Official will contact the applicant to discuss the proposed U18 milestones and any changes suggested by NIH staff or the NIH review panel. The Program Official and the applicant will negotiate and agree on a final set of approved U18 milestones that will be specified in the Notice of Award. These milestones will be the basis for judging the successful completion of the work.

Additional Considerations

NCATS Computing resources:

The NCATS Information Resources Technology Branch (ITRB) will provide awardees 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, project, 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
  • If requested, access to NCATS' Federated Authorization Software as a Service (SaaS) to any of the ASPIRE awardees systems and applications, if requested, 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. This instance would be co-managed by the awardee and NCATS ITRB. Access to the awardees cloud instance would be managed using NCATS' Federated Authorization System and the awardees would have complete rights to all services provided by the Cloud Service Provider.

Federated Authorization Services SaaS

If requested, at no cost to the awardee, NCATS ITRB would provide access to NCATS' Federated Authorization Service. The awardee could use NCATS' Authorization Service to provide for federated access to any of their systems and applications.

Cloud Engineering Support

If requested, 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 (HPC)

If requested, NCATS ITRB can also provide a cloud based elastic 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.

Subject Matter Expert:

Extramural investigator(s) are advised to recruit all the expertise that is needed for the development of the specific virtual module of interest and leverage it with the existing NCATS expertise.

Collaboration Plan:

 Applications for this program will be submitted by the extramural institution with the NCATS intramural scientist(s) integrated into the application as described in the Collaboration Plan (please see below). Annual progress reports will be prepared and submitted by the extramural institutions, with the participation and input of the intramural investigator(s) and should include the project findings, publications, data and resource-sharing and impact of the collaborative project. This collaborative translational research between NCATS intramural scientists and extramural investigators will involve either a Cooperative Research and Development Agreement (CRADA) or Research Collaboration Agreement (RCA), which will need to be executed for projects deemed scientifically meritorious by peer review and prior to funding. NCATS will provide CRADA or RCA template documents to help streamline the interaction between NCATS intramural scientists and extramural investigators. These template agreements can be found on https://ncats.nih.gov/alliances/forms. Questions regarding any of these agreements can be referred to the NCATS Office of Strategic Alliances at NCATSPartnerships@mail.nih.gov. Applicants should review this document and consult with their institutes about their willingness to agree to the conditions well in advance of submitting an application to this FOA. The CRADA or RCA will need to be executed after the application has been identified for funding. While the CRADA or RCA may not be in place prior to application submission, a statement from the applicant’s Sponsored Research Office that they agree, in principle, to the conditions of the CRADA/RCA should be included in the application.

 Important: As indicated above, potential applicants are required to consult with the Director of Automation and Compound Management, NCATS DPI (please see NCATS Intramural Program contact below). Early contact provides an opportunity for NCATS staff to discuss the program scope and goals and to provide information and guidance. Applications submitted without prior consultation with the NCATS DPI staff will be deemed ineligible.

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

NCATS intends to commit $2,000,000 in FY 2021 to fund 2 awards. Future year amounts will depend on annual appropriations.

Award Budget

Application budgets are limited to $400,000 direct costs in any fiscal year and need to 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 2 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

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Local Governments

  • State Governments
  • County Governments
  • City or Township Governments
  • Special District Governments
  • Indian/Native American Tribal Governments (Federally Recognized)
  • Indian/Native American Tribal Governments (Other than Federally Recognized)

Federal Governments

  • Eligible Agencies of the Federal Government
  • U.S. Territory or Possession

Other

  • Independent School Districts
  • Public Housing Authorities/Indian Housing Authorities
  • Native American Tribal Organizations (other than Federally recognized tribal governments)
  • Faith-based or Community-based Organizations
  • Regional Organizations
  • Non-domestic (non-U.S.) Entities (Foreign Institutions)
Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are 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.

This program requires the full collaboration of the extramural PD/PI of the applicant institution and the intramural investigator(s). Accordingly, the Multiple PD/PI model is allowed, but not required. For those applicants opting not to use the Multiple PD/PI model, the intramural investigator can hold any role other than the multiple PD/PI role. Applications must include at least one intramural scientist as either a Program Director/Principal Investigator or collaborator.

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&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.

Other Attachments

Collaboration Plan:

Applications must include a Collaboration Plan, describing how the proposed collaboration will be maintained throughout the duration of the award.

The following areas should be addressed:

  • Organizational structure
  • Management plan detailing how existing resources, including the NCATS DPI ASPIRE Program will be utilized
  • Planned interactions and responsibilities of key personnel
  • Clear and well described advantage to bringing the intramural and extramural investigators together in a collaborative partnership
  • A plan for handing scientific differences of opinion/conflicts that may arise between NCATS scientists and the extramural investigator
  • Description of how research teams will communicate (e.g., videocast, web meeting, etc.)
  • Description of how research teams will used shared code repositories (e.g., GitHub, etc.). Note: Please refer to the NIH Policy on Use of Hypertext in NIH Grant Applications (see NOT-OD-20-174).
  • Description of any pre-existing intellectual property

The filename "Collaboration Plan-PI-NAME.pdf" should be used, must not exceed 50 characters, and will be reflected in the final image bookmarking for easy access by reviewers. The Collaboration Plan is limited to 5 pages. Applications that do not include the Collaboration Plan will be considered incomplete and will not be reviewed.

Milestone Plan

Applications must include a Milestone Plan. The Milestone plan should:

  • Provide detailed quantitative criteria by which milestone achievement will be assessed.
  • Provide a detailed timeline for the anticipated attainment of each milestone and the overall goal.
  • Identify any impediments that could require an addendum to the research plan, milestones, or timeline with a discussion of alternative approaches.
  • A timeline (Gantt chart) including milestones is required for all studies. Yearly quantitative milestones are required in order to provide clear indicators of a project's continued success.

The filename "Milestone Plan-PI-NAME.pdf" should be used, must not exceed 50 characters, and will be reflected in the final image bookmarking for easy access by reviewers. The Milestone Plan is limited to 3 pages. Applications that do not include the Milestone Plan will be considered incomplete and will not be reviewed.

SF424(R&R) Senior/Key Person Profile

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

R&R Budget

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

Budget Justification:

Because of the anticipated complexity of the budget information and the need to clearly delineate costs for the extramural awardee, applicants must submit a detailed R&R budget. Submission of a Modular Budget is not allowed for this FOA.

The budget request for this FOA must distinguish between extramural costs and the NIH intramural investigator costs. Extramural costs are associated with the extramural investigator and the applicant organization. NIH intramural investigator costs are those required by the intramural investigator for carrying out the proposed work and which are specifically identified with the project.

Extramural Grantee Costs

Extramural costs of up to $400 000 per year may include such items as salary support for the extramural PD/PI and staff at the applicant organization, supplies, laboratory animals, data analysis, and other allowable costs for work performed at the (extramural) applicant organization, as well as travel costs for the extramural investigator(s).

  • The PD/PI and up to one other key personnel with complementary expertise are required to attend mandatory semi-annual program meetings. The meetings will be in person and alternate between NCATS, Rockville, MD, and extramural site(s). Funds to attend these meetings should be budgeted in the application.
  • Extramural costs should also include travel costs for in-person meetings with NCATS intramural collaborators.

F&A (Indirect) Costs: Applicant organizations are reminded that Facilities and Administrative (F&A) or “indirect costs” are allowable for only the allowable extramural costs of the project.

Intramural Investigator Costs

The requests by NIH intramural scientists will be limited to the incremental costs required for participation. Intramural investigator costs may include salary for contract staff to be specifically hired under a temporary appointment for the project, consultant costs, supplies, and other items typically listed under Other Expenses. Budget requests from the NIH intramural program may not include any salary and related fringe benefits for career, career conditional or other federal employees (civilian or uniformed service) with permanent appointments under existing position ceilings or any costs related to administrative or facilities support (equivalent to Facilities and Administrative costs). Although the budget request may not include salary support for such individuals, it should indicate person months for any key personnel. Resources required need to be determined before the research protocol can be approved by the respective NIH Institute/Center. Prospective applicants are strongly encouraged to contact NCATS staff to discuss intramural investigator costs.

Once the intramural investigator costs are known, the extramural applicant will enter this amount as a "subaward" budget in the application, and attach appropriate justification and documentation, including any spreadsheets as appropriate. The intramural investigator's costs will not be included in the award paid to the grantee. Support for intramural participation will be provided by a budget allocation within the NIH.

Peer reviewers will evaluate the appropriateness of the IRP staff and budget request for the work proposed and will therefore need to know the level of effort being proposed to conduct the work.

Additional Guidance on Budget Preparation

The project will initially focus on development of a module at the extramural site. Once a module is completed, extramural investigators will transfer the module and associated protocol to NCATS site for validation and incorporation into NCATS ASPIRE. The application budget should reflect actual needs of the proposed project and align with the distribution of the work during the project.

The budget requests for this FOA are more complex and will require more coordination than those of other programs. Therefore, extramural investigators are encouraged to begin discussions about logistics and budget issues with their intramural collaborators and with NIH staff in the early phases of application preparation.

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:

Letters of Support:

  1. Letter of  Collaborationfrom NCATS DPI:

Applications submitted in response to this FOA must include a current (i.e., within two months of application due date) letter from the Scientific Director of the NCATS Division of Preclinical Innovation to confirm that the NCATS ASPIRE Laboratory will be able to accommodate the proposed research and that the NCATS intramural scientist will be able to collaborate on the project. Applications submitted without this letter of collaborationwill be considered incomplete and will not be reviewed. Note: the letter of collaboration from Scientific Director of NCATS/DPI does not constitute pre-approval of the application or award.

  1. Letter of Support from Applicant Institution on CRADA

The application should include a statement from the applicant’s Sponsored Research Office (or equivalent) that they agree, in principle, to the conditions of the CRADA/RCA. Failure to include this statement could result in delays should the application be identified for funding. For more details please see Collaboration Plan in Additional Considerations Section above.

  1. Letter(s) of Support from Collaborator(s)

Letter(s) from other collaborators/consultants confirming participation should also be included.

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:

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

Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

PHS Human Subjects and Clinical Trials Information

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

PHS Assignment Request Form

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

Foreign Institutions

Foreign (non-U.S.) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.

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 and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Applications Involving the NIH Intramural Research Program

The requests by NIH intramural scientists will be limited to the incremental costs required for participation. As such, these requests will not include any salary and related fringe benefits for career, career conditional or other Federal employees (civilian or uniformed service) with permanent appointments under existing position ceilings or any costs related to administrative or facilities support (equivalent to Facilities and Administrative or F&A costs). These costs may include salary for staff to be specifically hired under a temporary appointment for the project, consultant costs, equipment, supplies, travel, and other items typically listed under Other Expenses. Applicants should indicate the number of person-months devoted to the project, even if no funds are requested for salary and fringe benefits.

If selected, appropriate funding will be provided by the NIH Intramural Program. NIH intramural scientists will participate in this program as PDs/PIs in accord with the Terms and Conditions provided in this FOA. Intellectual property will be managed in accord with established policy of the NIH in compliance with Executive Order 10096, as amended, 45 CFR Part 7; patent rights for inventions developed in NIH facilities are NIH property unless NIH waives its rights.

Should an extramural application include the collaboration with an intramural scientist, no funds for the support of the intramural scientist may be requested in the application. The intramural scientist may submit a separate request for intramural funding as described above.

Pre-Application Webinar

A technical assistance webinar will be held for potential applicants from 12:00 - 1:00 pm (ET) on Wednesday, April 7, 2021. NIH staff will be available to answer questions related to this and companion FOA.

To join the webinar, pre-registration is required. Webinar information will be provided upon request to dobrila.rudnicki@nih.gov.

Potential applicants are encouraged to submit questions by March 31, 2021 to dobrila.rudnicki@nih.gov.

Slides and FAQs will be available at https://ncats.nih.gov/aspire/funding approximately 7 days following the completion of the webinar. Participation in this webinar, although encouraged, is optional and is not required for the submission of an 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.

For this particular announcement, note the following: The U18 grant application is not required to have extensive preliminary data, background material or preliminary information, but these may be included if available. Appropriate justification for the proposed work can also be provided through literature citations, data from other sources, or, when available, from investigator-generated data. Accordingly, reviewers will focus their evaluation on the conceptual framework, the level of innovation, and the potential to significantly advance our knowledge or understanding.

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:

  • How relevant is the proposed virtual module to the translational problem that will be addressed?
  • What is the likelihood that the proposed virtual module will be relevant beyond the primary disease/translational focus of this application? Will the proposed virtual module have an ability to be used collaboratively by multiple investigators in a shared cloud environment?

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:

  • If applicable, is the Multi-PI leadership plan, well-described, including plans for dispute resolution?
  • Have project leadership and other key personnel demonstrated a record of directing research activities related to development of a module of interest?
  • If this is relevant to the proposed virtual module, are the collaborations with disease experts well-documented?
  • How extensive is the PD/PI experience with working in collaborative development environments using shared cloud resources?

Collaboration Plan

  • Is the Collaboration Plan well defined with identifiable responsibilities for the NIH intramural investigator and the extramural applicant?
  • Is a plan for management of the collaboration clearly presented, with well-defined descriptions of what each participant proposes to provide to the collaborative partnership?
  • Is there a clear and well described advantage to bringing the intramural and extramural investigators together in a collaborative partnership?

Innovation

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

Specific to this FOA:

  • To what extent will this application facilitate translational and clinical research between NCATS intramural scientists and the extramural community to develop approaches that will enhance our ability to discover and develop new chemistries designed towards previously undrugged biological targets?
  • To what extent will the proposed virtual module improve the ability to advance discovery and development of novel treatments, beyond the current focus of the application?
  • To what extent will the proposed approach inform development of additional virtual, as well as physical modules that may be incorporated in the platform in the future?
  • Will the proposed approach have the capability of being used both for the ASPIRE initiative but also other cheminformatics and/or distributed automation projects?
  • Are the overall goals of the application conducive to generating significant multidisciplinary investigations that facilitate development of a proposed module?
  • To what extent does the project utilize current advances and cutting-edge technologies?

Approach

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

Specific to this FOA:

  • Are the proposed approaches state-of-the-art and scientifically justified?
  • How well does the application identify major technical risks, and are the proposed efforts to mitigate or address the risks clearly defined and feasible?

Milestones:

  • How appropriate are the listed milestones for the overall goals of the project?
  • To what extent do the milestones address the specific aims of the project?
  • How feasible, well developed, and quantifiable are the proposed milestones?
  • Are quantifiable go/no go criteria included?
  • How appropriate are quantifiable go/no go criteria for the milestones proposed?
  • How reasonable are the critical decision points and timelines for the deliverables proposed?
  • Does the approach allow for a smooth transition from the investigators’ laboratory to NCATS?

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?

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?

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

Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

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 (GDS).

Authentication of Key Biological and/or Chemical Resources:

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

Budget and Period of Support

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

2. Review and Selection Process

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

As part of the scientific peer review, all applications will receive a written critique.

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

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

Applications will be assigned 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 NCATS 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.
  • Likelihood of effective collaboration between the PD(s)/PI(s) of the applicant institution(s) and the NIH intramural investigators(s).
  • Utilization of unique opportunities available at the NCATS.

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.

Institutional Review Board or Independent Ethics Committee Approval: Grantee 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, 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 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 awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

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

  • Defining the details and goals of the project within the guidelines of this FOA.
  • Determining experimental approaches, designing protocols, setting project milestones, and conducting experiments
  • Adhering to the NIH policies regarding intellectual property, data release and other policies that might be established during the project.
  • Fully participating in the highly collaborative nature of the NCATS ASPIRE program
  • Attending semi-annual in person or virtual meetings organized by the NIH
  • Coordinating, cooperating, and participating with NIH staff in the scientific, technical, and administrative management.
  • Identifying and maintaining infrastructure and collaborations needed to support the development of the proposed virtual module.
  • Performing established standardization and validation milestones.
  • Ensuring that all affiliated staff will maintain the confidentiality of the information developed by the investigations, including, without limitation, informatics tools, protocols, data analysis, conclusions, etc.
  • Analyzing, publishing and/or publicly releasing and disseminating results, data and other products of the study in a timely manner, concordant with the approved plan for making quality-assured data and materials available to the scientific community and the NIH, consistent with NIH policies and goals of the FOA.
  • Participating in a cooperative and interactive manner with NIH staff, other NCATS ASPIRE investigators and one another.
  • Sharing data, materials, informatics tools, methods, information and unique resources that are generated by the project as appropriate and in accordance with NIH policies in order to facilitate progress and consistent with achieving the goals of the NCATS ASPIRE program.
  • Ensuring that for activities that involve academic and/or industry collaborations within and outside the NCATS ASPIRE program there are appropriate research collaboration agreements (e.g., CRA, CDA, MTA etc.) with terms that ensure the collaboration is conducted in accordance with the Cooperative Agreement terms of award as well as any additional applicable NIH policies and procedures.
  • Ensuring that the research is conducted in accordance with processes and goals as delineated in this Funding Opportunity Announcement.

Upon completion or termination of the project, ensuring all study materials, tools, databases and procedures developed from the project are broadly available (e.g., putting into the public domain) or made accessible to the research community according to the NIH-approved plan submitted for each project, for making data and materials available to the scientific community and the NIH for the conduct of research. The data sharing plan should include a plan to accomplish this within 90 days of the end of the study.

Publications

The Program Director/Principal Investigator (PD/PI) will be responsible for the timely submission of all abstracts, manuscripts, and reviews (co)authored by project investigators and supported in whole or in part under this Cooperative Agreement. The PD/PI and Project Leaders are requested to submit manuscripts to the NIH Project Scientist within two weeks of acceptance for publication so that an up-to-date summary of program accomplishments can be maintained. Publications and oral presentations of work conducted under this Cooperative Agreement are the responsibility of the Principal Investigator and appropriate Project Leaders and will require appropriate acknowledgement of NIH support. Timely publication of major findings is expected.

Communication Plans

The Principal Investigator(s) will be responsible for:

  • Participating in regular (monthly) conference calls with all NCATS ASPIRE Team members.
  • Coordinating efforts with other awardees, especially in circumstances where synergy of efforts and resources is beneficial to the overall goals of the NCATS ASPIRE program.
  • Participating and presenting findings at the semi-annual in-person or virtual meetings convened by the NIH.
  • Coordinating or jointly publishing findings in a timely manner, and as to have the broadest impact.
  • Making new information and materials known to the research community in a timely manner through publications, web announcements, reports to the NCATS ASPIRE Project Scientist, and other mechanisms.

Intellectual Property

The awardee is solely responsible for the timely acquisition of all appropriate proprietary rights, licenses, and all materials needed for the applicant to perform the project.

Before, during, and subsequent to the award, the U.S. Government is not required to obtain for the awardee any proprietary rights, including intellectual property rights, or any materials needed by the awardee to perform the project. The awardee is required to report to the U.S. Government all inventions made in the performance of the project, as specified by 35 U.S.C. Sect. 202 (Bayh-Dole Act). Awardees will retain custody of and have primary rights to the data and resources developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies.

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

NCATS will designate program staff, including a Program Officer, to provide stewardship and administrative oversight of the cooperative agreement. The Program Officer will be named in the Notice of Award (NoA).

The Program Officer will:

  • Be responsible for the normal scientific and programmatic stewardship of the award.
  • Participate in project update meetings and conference calls.
  • Approve modifications to the research plan based on emerging data and/or other issues that impact progress of the project.
  • Reserve the right to obtain periodic external review and select reviewers for an assessment of progress and achievement of milestones.
  • Reserve the right to terminate or curtail a project for any of the following reasons: (1) inadequate progress in meeting the pre-negotiated milestones and timelines; (2) risk(s) to subject’s safety; (3) slow accrual; (4) data from a futility analysis; or (5) failure to comply with the Terms and Conditions of Award

The NIH intramural scientist will be responsible for:

  • Providing advice and technical assistance as needed during the entire course of the project.
  • Managing and executing validation and integration of a virtual module in the NCATS ASPIRE platform, as described in the project milestones.
  • Participating in the analysis, interpretation, and reporting of findings in the scientific literature, to the community at large and to the public policy community within the Federal government through various media, as appropriate

The NIH intramural scientist is subject to the same publication/authorship policies as the official NIH publication policy.

The NIH reserves the right to curtail or phase out the award in the event of (1) a substantial shortfall in accomplishing the management goals and responsibilities as stated in the reviewed application, (2) failure to meet procedures and milestones, and/or (3) substantive changes in the management of award(s) that are not in keeping with the objectives of the FOA.

Areas of Joint Responsibility include:

Since the purpose of this FOA is to establish and/or further develop collaborative arrangements between extramural and intramural investigators, many responsibilities are shared between awardees and NIH staff and will require close coordination. Responsibilities will be divided between awardees and NIH staff, as described above. Awardees will participate in monthly calls with the NIH and semi-annual meetings. Annual progress reports will be prepared and submitted by the extramural institutions, with the participation and input of the intramural investigator(s) and should include the project findings, publications, impact of the project, a description of what NCATS ASPIRE laboratory unique resources were utilized and the new intramural-extramural partnerships that developed. This will be evaluated by the program official/IC program director.

Data

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

Performance Requirements:

  • Meeting yearly milestones as defined by extramural and intramural investigators and NIH program at the time of award.
  • Working with, cooperatively interacting with, and actively seeking input from NIH.
  • Sharing data and biological specimens with the broader scientific community, using established data sharing guidelines.
  • Attending semi-annual in-person or virtual meetings.

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 awardee, and NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two. 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.

T&C Inclusions and Modifications:

The Terms and Conditions of Award will include references to the currently approved versions of the Collaboration Plan and the Sharing Plans for Resources and Data. Before the initial award is made, NIH and the awardees may negotiate changes or additions to the versions of these plans in the application. Future changes or additions to these plans may be developed by the NIH and the PD(s)/PI(s) and negotiated with the awardee. Changes will be documented by an exchange of correspondence and the updated plans will become part of the Terms and Conditions of a revised Notice of Award.

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)

Extramural Program:

Dobrila D. Rudnicki, Ph.D.
National Center for Advancing Translational Sciences (NCATS)
Telephone: 301-594-2080
Email: dobrila.rudnicki@nih.gov

Danilo A. Tagle, Ph.D.
National Center for Advancing Translational Sciences (NCATS)
Telephone: 301-594-8064
Email: danilo.tagle@nih.gov

Leah Croucher, Ph.D.
National Center for Advancing Translational Sciences (NCATS)
Telephone: 301-594-8921
Email: leah.croucher@nih.gov
 

Intramural Program:
Anton Simeonov, Ph.D.
Director, NCATS Division of Preclinical Innovation
National Center for Advancing Translational Sciences (NCATS)
Telephone: 301-217-5721
Email: anton.simeonov@nih.gov
 

Sam Michael, Ph.D.
CIO, Director of Compound Management and Automation
National Center for Advancing Translational Sciences (NCATS)
Telephone: 301-827-7796
Email: michaelsg@mail.nih.gov
 

Peer Review Contact(s)

Carol Lambert, Ph.D.

National Center for Advancing Translational Sciences (NCATS)

Telephone: 301-435-0814

Email: lambert@mail.nih.gov

Financial/Grants Management Contact(s)

Zulema Eldridge

National Center for Advancing Translational Sciences (NCATS)

Telephone: 301-443-3066

Email: zulema.eldridge@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.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
NIH Office of Extramural Research Logo
Department of Health and Human Services (HHS) - Home Page
Department of Health
and Human Services (HHS)
USA.gov - Government Made Easy
NIH... Turning Discovery Into Health®


Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files.