Part 1. Overview Information

Key Dates

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

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

It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide, except where instructed to do otherwise (in this NOFO or in a Notice from NIH Guide for Grants and Contracts).

Conformance to all requirements (both in the Application Guide and the NOFO) 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.



Table of Contents
Part 1. Overview Information
Key Dates
Part 2. Full Text of Announcement
Section I. Notice of Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

Research Objectives and Purpose:

The development and implementation of clinical interventions is a complex, iterative, and time-consuming process that takes years before discoveries in biomedical research result in health benefits for patients and communities. The National Center for Advancing Translational Sciences (NCATS) has the unique charge of examining the translational research ecosystem at a systems level to determine where common pitfalls exist in the translational process and developing innovative solutions that will ultimately benefit research across a range of diseases and conditions. This disease-agnostic approach to enhancing the efficiency and effectiveness of all translational research is known as translational science, which focuses on building the evidence base for effective scientific and operational approaches in translational research. NCATS conducts and supports research in the science of translation to discover the scientific, mechanistic, and operational principles of the intervention development and dissemination processes, thereby providing the scientific foundation for improvements in translational efficiency that will accelerate the realization of interventions that improve human health.

The purpose of the High Impact Specialized Innovation Programs (SIPs) is to support unique activities, resources, capabilities and/or expertise at awarded CTSA UM1 (PAR-24-272) hubs to help advance one or more of the NCATS CTSA Program goals. The SIPs initiative is envisioned as part of the current innovation ecosystem to support the generation of a research resource and/or foster discovery-based or hypothesis-generating science that can have a significant impact in Clinical and Translational Science (CTS). Specifically, this limited competition Notice of Funding Opportunity (NOFO) seeks to support novel approaches in areas that address specific knowledge gaps, scientific opportunities, new technologies/platforms, data generation and/or analysis, or novel research methods that will advance clinical and translational science (CTS) and research (CTR) at CTSA UM1 hubs . Resources, activities, and expertise supported through the RC2 mechanism are expected to be available to enhance the development and demonstration activities or projects within a CTSA hub. These include utilization of resources, expertise, tools and platforms for pilot projects, research projects and other CTS activities within hubs. Examples of SIPs areas in clinical and translational science include but are not limited to  digital health, decentralized clinical trials, pragmatic trials,  artificial intelligence/machine learning algorithms, point-of-care clinical decision support systems, data science and statistical methods, real-world data and real-world evidence, innovative clinical trial designs, genetics and genomics.  In addition, novel strategies and/or approaches for dissemination and implementation, rural health and health disparities, clinical informatics, biostatistics, community outreach and engagement, regulatory science, telehealth, and other areas of need for specialized programs.

Scope and Specific Requirements:

Through the RC2 mechanism, SIPs should address one or more of the following objectives: 

• Groundbreaking, innovative, high impact and cross-cutting research, resources and/or activities that address one or more of the CTSA Program Goals and have the highest potential to improve and accelerate biomedical research at UM1 hubs.
• Programs in Clinical and Translational Science that could fundamentally enhance the research enterprise and that require the participation, interaction, coordination, and integration of activities within a CTSA UM1 hub .
• Creation of unique resources and/or development of transformative technologies and/or platforms that can benefit a wide range of projects and/or activities related to CTS at CTSA UM1 hubs.
• High-impact discovery-based projects or hypothesis-generating science.

While preliminary data is not required, it is important to provide strong rationale and justification for the goals of the application. Applications for SIP must include: a UM1 and RC2 Coordination and Integration Plan, a Program Milestones table and a Program Evaluation and Sustainability Plan as separate attachments (see Section IV. Application and Submission Information SF424(R&R) Other Project Information)

Potential applicants are highly encouraged to contact NCATS Scientific/Research Contacts listed in this NOFO to discuss the scope of the project, required materials, responsiveness, and clinical trials status designation prior to submission of an application. 

 Collaborations with other components of the CTSA UM1 hub and/or with institutions listed as partners and/or collaborators are encouraged. Also, collaborations with other CTSA UM1 and UL1 hubs and with non-CTSA organizations are encouraged. The requested project period may be up to 5 years.

Applications Not Responsive to this NOFO:

The following types of studies are not responsive to this NOFO. Applications proposing such studies will be considered non-responsive and will not be reviewed or considered for funding.

Applications that propose:

• Feasibility/Pilot projects intended to: (1) explore possible innovative new leads or new directions for established investigators; (2) stimulate investigators from other areas to lend their expertise in research in CTS; and (3) provide initial support to establish proof of concept. Pilot projects are supported through the CTS Pilot Module within the UM1.Traditional investigator-initiated, hypothesis-driven and highly focused studies (best supported through CTSA UM1 CTS Research Projects) or specific projects requiring multiple collaborators (best supported through CTSA Collaborative Innovation Awards).
• Dissemination and implementation of novel resources/activities/projects at other hubs. 
• Ancillary studies or research that is a logical extension of ongoing work.
• Core (or related) services to supplement the budgets of existing UM1 efforts.
• Applications with Studies with a major emphasis outside of the NCATS Strategic Plan and the goals of the CTSA Program.

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

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

Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs.

Section II. Award Information

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

Section III. Eligibility Information

1. Eligible Applicants

All applicant organizations and/or active award recipients for PAR-24-272 Clinical and Translational Science Award (UM1 Clinical Trial Optional) are eligible to apply under this NOFO. 

Only the primary UM1 CTSA program hub organization is eligible to apply (not partner or collaborator institutions). 

RC2 companion optional applications may be submitted under the following scenarios:

 -concurrently with the UM1 

-while the UM1 application is under review consideration 

-after the UM1 application is funded 

-while the UM1 is under consideration for funding 

RC2 applications will only be awarded if there is an awarded UM1 application from the RC2 applicant organization.

Non-domestic (non-U.S.) Entities (Foreign Organizations) 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.

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the How to Apply- 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. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference the NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications for additional information.

• System for Award Management (SAM) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
  • Unique Entity Identifier (UEI) - A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
• eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.gov registrations; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov – Applicants must have an active SAM registration in order to complete the Grants.gov registration.

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

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

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 their organization to develop an application for support. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019.

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 How to Apply-Application Guide.

The single PD/PI (or contact PD/PI for a multiple PI application) must be employed by and/or a recipient of funding and/or have an academic appointment from a CTSA Program UM1 hub prime institution as defined above in Eligible Organizations. Investigators from UM1 hub partners or collaborators who wish to co-lead a SIP, can co-direct in partnership with a contact PD/PI who is employed by and/or a recipient of funding and/or has an academic appointment at a CTSA Program UM1 prime hub institution using the multiple PD/PI option.

See required Letters of Support. (see Section IV. Application and Submission Information, 2. Content and Form of Application Submission, PHS 398 Research Plan.)

2. Cost Sharing

This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement Section 1.2 Definition of Terms.

3. Additional Information on Eligibility

Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

The NIH will not accept duplicate or highly overlapping applications under review at the same time, per NIH Grants Policy Statement Section 2.3.7.4 Submission of Resubmission Application. This means that the NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see NIH Grants Policy Statement 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

Other information on eligibility and number of applications:

• An active (not in an extension period) UM1 hub institution can submit up to two RC2 applications for SIPs per cycle as the primary institution.
• A CTSA UM1 hub may have up to two RC2 SIPs awards as the primary recipient at a given time.
• No more than two RC2 applications may be submitted by a UM1 hub as a primary per application due date and no more than two RC2 applications may be awarded to an active (not in an extension period) CTSA UM1 hub as a primary recipient, at a given time.
•  A UM1 hub that is in an extension period is not allowed to submit an RC2 application as the primary institution unless a pending UM1 application has been submitted or is under review or funding consideration. Resubmission of a RC2 application without the required UM1 application is only allowed if the companion UM1 application is awarded. 
• For the purpose of this NOFO, an RC2 in an extension period counts towards the maximum of two RC2s that may be awarded to an active UM1 hub as a primary, at a given time.

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 NOFO. 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 How to Apply - Application Guide except where instructed in this notice of funding opportunity 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:

NCATS Letters of Intent 
Telephone: 301-827-9549 
Email: [email protected]  

Page Limitations

All page limitations described in the How to Apply- Application Guide and the Table of Page Limits must be followed.

The following section supplements the instructions found in the How to Apply- Application Guide and should be used for preparing an application to this NOFO.

SF424(R&R) Cover

All instructions in the How to Apply - Application Guide must be followed.

SF424(R&R) Project/Performance Site Locations

All instructions in the How to Apply- Application Guide must be followed.

SF424(R&R) Other Project Information

All instructions in the How to Apply- Application Guide must be followed.

The application must include the following 3 attachments. Please use the filenames suggested below. The filename provided for each document added to the section “Other Attachments” will be the name used for the bookmark in the electronic application in eRA Commons.

Attachment #1 (Up to 2 pages in length) called "UM1 and RC2 Coordination and Integration Plan" must be uploaded under Other Attachments.  The UM1 and RC2 Coordination and Integration Plan must provide a specific plan describing the collaboration, support, equipment, coordination, synergy and integration between the UM1 hub and any of its elements and modules and other UM1 companion NOFOs and the proposed RC2 Program. Applications that do not include UM1 and RC2 Coordination and Integration Plan will not be reviewed.

Attachment #2 (Up to 1 page in length) called “Program Milestones” must be uploaded under Other Attachments. The Program Milestones must include a table with key milestones to be achieved throughout the RC2 program period. Both short-term/interim (monthly or quarterly) and long-term (yearly) milestones should be clearly outlined in word table format. Each milestone should be constructed to succinctly include: (a) the goals and timeline for completion, (b) the criteria for success, including quantitative and/or qualitative metrics that will be used to assess success. Final program milestones for each RC2 may be changed based on suggestions from reviewers or NIH program staff and will be negotiated with program staff prior to funding the application. The final agreed upon and approved milestones will be specified in the Notice of Award (NoA). Applications that do not include Program Milestones will not be reviewed.

Attachment #3 (Up to 2 pages in length) called “Program Evaluation and Sustainability Plan” must be uploaded under Other Attachments. The Program Evaluation and Sustainability Plan must provide a clear plan to evaluate the success and impact of the proposed program based on the pre-determined milestones and SIP utilization at participating institutions. List key metrics and measures of success to be utilized to evaluate the overall impact of the program and how success will be measured in an objective and tangible manner on a regular basis. In addition, outline plans for sustainability of the SIP beyond the RC2 grant period (once grant funding ends) and how do applicants envision their Specialized Innovation Program to continue through partnerships, collaborations, support, etc. after the RC2 ends. Applications that do not include the Program Evaluation and Sustainability Plan will not be reviewed.

Applications that do not include one or more of these attachments will be considered incomplete and will not be reviewed.

SF424(R&R) Senior/Key Person Profile

All instructions in the How to Apply- Application Guide must be followed.

R&R Budget

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

• Key Personnel salaries derived from the grant will depend on the effort provided and institutional salary as well as existing NIH policies. It is recommended that the contact PD/PI devote at least one to two person months of his/her efforts to the project. No overlap of time or effort between this award and separately funded projects is permitted.
• Consultants and any associated costs (consultant fees, per diem, travel) may be included when their services are required and justified within the award.
• RC2 budget should include travel expenses for appropriate personnel (up to three people) to attend a yearly in-person meeting to present RC2 progress, lessons learned and impact. If additional staff are identified to attend, additional justification is required as part of the Budget Justification.

R&R Subaward Budget

All instructions in the How to Apply-Application Guide must be followed.

PHS 398 Cover Page Supplement

All instructions in the How to Apply- Application Guide must be followed.

PHS 398 Research Plan

All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions:

Specific Aims:

Briefly state the specific aims of the project indicating how the hub will develop and/or demonstrate a highly innovative and specialized clinical and translational science program that addresses one or more of the CTSA Program goals.

Research Strategy:

This opportunity may support high impact unique activities, resources, expertise or capabilities that may lay the foundation for new fields of investigation; accelerate breakthroughs; stimulate early and applied research on cutting-edge technologies/platforms; foster new approaches to improve the interactions among multi- and interdisciplinary research teams to help advance the clinical and translational research enterprise in a way that could stimulate future growth and investments and advance public health and health care delivery. This activity code may support either a specific question related to the advancement of clinical and translational science or propose the creation of a unique infrastructure/resource designed to accelerate clinical and translational science at UM1 hubs. A description of the specialized team(s) that is/are part of the proposed SIP as well as their experience is expected.

In addition, applicants must concisely describe the significance of the problem/roadblock or gap being addressed and their relevance to the goals of the CTSA Program. Applicant should specifically address why the proposed SIP is best suited to respond to UM1 hub needs, as described below. The application must provide an explanation of how the proposed program will empower research, generate new hypotheses, or contribute a significant resource, platform, tool, data or technology that is currently lacking and could help advance the development of new approaches, solutions, therapeutics, devices and/or diagnostics to improve human health. Programs are expected to demonstrate the following:

• The work cannot be reasonably expected to be carried out successfully without support provided by this NOFO.
• Specific outcomes of the proposed program promote and advance the NCATS Strategic Plan and, specifically addresses one or more of the CTSA Program Goals.
• Funding will accelerate the development of innovative resources, approaches, tools, solutions, therapies, diagnostics, devices and/or applications and help overcome roadblocks in clinical and translational science.
• The proposed project is something that will help catalyze clinical and translational science locally at UM1 hubs and no other existing project/resource is likely or able to do.
• The project or generated results and resources can be expected to become integrated into the broader clinical and translational science community locally, regionally and/or nationally.
• There is a plan for evaluation and sustainability of applicable research efforts and resources beyond the RC2 funding.

Critical Need/Gap Area Addressed:

Describe how is the proposed project is unique and how it is expected to solve a real gap or overcome a key roadblock in clinical and translational science. The capability must directly address one or more of the current CTSA Program Goals. It is expected that the capability or resource will be in an area of need where there are currently no clearly available solutions/tools/resources or where the existing solutions are suboptimal. The identification of a critical gap(s) or area(s) of need should be based on evidence and supported by most up-to-date science in the field. 

Impact:

In addition, applicants must justify how the local innovations developed through their proposed RC2 could impact health and medicine by  meaningfully advancing clinical and translational science within their UM1 hub and, if successful, how their proposed RC2 could be more broadly disseminated throughout the CTSA consortium. Also how does the proposed RC2 changes the landscape of what’s currently being done in the specific field and how it can help advance clinical and translational science and make a difference in medicine and health.

Letters of Support: Applicants must provide a letter from the UM1 hub Principal Investigator describing how the proposed SIP is expected to be integrated within the CTSA hub as well as the resources, expertise that the CTSA hub will provide. In addition, any resources or expertise outside of the team of investigators, including institutional support through core facilities or resources, must be evidenced by appropriate letters of support from the relevant individual(s). Applications that do not include a letter from the UM1 hub Principal Investigator will not be reviewed.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply- Application Guide.

The CTSA Program encourages sharing of resources with broad availability of policies, practices, materials, and tools to facilitate collaboration, reuse, and replication. 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://sharing.nih.gov/sites/default/files/flmngr/Research_Tools_Federal_Register.pdf ). This document will assist recipients in determining reasonable terms and conditions for disseminating and acquiring research tools.

For the purposes of this NOFO the research tool may include, but is not limited to, software, algorithms, and code. This may be for extraction and use of data for research from clinical systems; implementation of new efficient workflows for research studies; innovative networking to connect scientists, patient communities, industry, resources, data, and ideas; novel analytic and analysis programs; and educational tools. The Resource Sharing Plan must include the following:

• The software should be freely available to biomedical researchers, health care systems, and research institutions or organizations.
• The terms should also permit the dissemination and commercialization of enhanced or customized versions of the software, or incorporation of the software or components of it into other software packages.
• The terms of software availability should include the ability of individuals outside the applicant institution and its collaborating organizations to modify the source code and to share modifications with other colleagues.

Prior to funding, NIH Program Staff may negotiate modifications to the Resource Sharing Plan with the applicant.

Other Plan(s): 

All instructions in the How to Apply-Application Guide must be followed, with the following additional instructions:

• Genomic Data Sharing Plan: Awardees are strongly encouraged to deposit large-scale, human genetic data in the database for Genotype and Phenotype “dbGaP” (https://www.ncbi.nlm.nih.gov/gap). For other data and biospecimens from human genetic or non-genetic studies, awardees are encouraged to use the NICHD Data and Specimen Hub “DASH” (https://dash.nichd.nih.gov/) or other equivalent broad-sharing data and/or biospecimen repositories.
•  All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan.

Appendix: Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the How to Apply- 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 How to Apply- 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 How to Apply- 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 How to Apply- Application Guide must be followed.

PHS Assignment Request Form

All instructions in the How to Apply- Application Guide must be followed.

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

See Part 2. 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. 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 Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications.

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 How to Apply-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 Section 7.9.1 Selected Items of Cost.

Applications must be submitted electronically following the instructions described in the How to Apply 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 form. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this NOFO for information on registration requirements.

The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the How to Apply 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 NCATS, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

In order to expedite review, applicants are requested to notify the NCATS Referral Office by email at [email protected] when the application has been submitted. Please include the NOFO number and title, PD/PI name, and title of the application.

Recipients or subrecipients must submit any information related to violations of federal criminal law involving fraud, bribery, or gratuity violations potentially affecting the federal award. See Mandatory Disclosures, 2 CFR 200.113 and NIH Grants Policy Statement Section 4.1.35.

Send written disclosures to the NIH Chief Grants Management Officer listed on the Notice of Award for the IC that funded the award and to the HHS Office of Inspector Grant Self Disclosure Program at [email protected].

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described 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.

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 scored review criteria and additional review criteria (as applicable for the project proposed). An application does not need to be strong in all categories to be judged likely to have a major scientific impact.

Reviewers will evaluate Factors 1, 2 and 3 in the determination of scientific merit, and in providing an overall impact score. In addition, Factors 1 and 2 will each receive a separate criterion score. 

As applicable for the project proposed, reviewers will consider the following additional items while determining scientific and technical merit, but will not give criterion scores for these items, and should consider them in providing an overall impact score.

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.

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 NOFO. 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.

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 Section 2.5.1. Just-in-Time Procedures. This request is not a Notice of Award nor should it be construed to be an indicator of possible funding.

Prior to making an award, NIH reviews an applicant’s federal award history in SAM.gov to ensure sound business practices. An applicant can review and comment on any information in the Responsibility/Qualification records available in SAM.gov. NIH will consider any comments by the applicant in the Responsibility/Qualification records in SAM.gov to ascertain the applicant’s integrity, business ethics, and performance record of managing Federal awards per 2 CFR Part 200.206 “Federal awarding agency review of risk posed by applicants.” This provision will apply to all NIH grants and cooperative agreements except fellowships.

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 2.4.4 Disposition of Applications.

Section VI. Award Administration Information

1. Award Notices

A Notice of Award (NoA) is the official authorizing document notifying the applicant that an award has been made and that funds may be requested from the designated HHS payment system or office. The NoA is signed by the Grants Management Officer and emailed to the recipient’s business official.

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

Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Any pre-award costs incurred before receipt of the NoA are at the applicant's own risk.  For more information on the Notice of Award, please refer to the NIH Grants Policy Statement Section 5. The Notice of Award and NIH Grants & Funding website, see Award Process.

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

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

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

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

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

2. Administrative and National Policy Requirements

The following Federal wide and HHS-specific policy requirements apply to awards funded through NIH:

• The rules listed at 2 CFR Part 200, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards.
• All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the terms and conditions in the Notice of Award (NoA). The NoA includes the requirements of this NOFO. 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.
• If a recipient receives an award, the recipient must follow all applicable nondiscrimination laws. The recipient agrees to this when registering in SAM.gov. The recipient must also submit an Assurance of Compliance (HHS-690). To learn more, see the Laws and Regulations Enforced by the HHS Office for Civil Rights website.
  • HHS recognizes that NIH 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 NOFO.

All federal statutes and regulations relevant to federal financial assistance, including those highlighted in NIH Grants Policy Statement Section 4 Public Policy Requirements, Objectives and Other Appropriation Mandates.

Recipients are responsible for ensuring that their activities comply with all applicable federal regulations.  NIH may terminate awards under certain circumstances.  See 2 CFR Part 200.340 Termination and NIH Grants Policy Statement Section 8.5.2 Remedies for Noncompliance or Enforcement Actions: Suspension, Termination, and Withholding of Support. 

Not Applicable

Consistent with the 2023 NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.

4. Reporting

When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement Section 8.4.1 Reporting. To learn more about post-award monitoring and reporting, see the NIH Grants & Funding website, see Post-Award Monitoring and Reporting.

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 Section 8.6 Closeout. NIH NOFOs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 2 CFR Part 200.301.

Section VII. Agency Contacts

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

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

Finding Help Online: https://www.era.nih.gov/need-help (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: [email protected] (preferred method of contact)
Telephone: 301-480-7075

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]

Pablo Cure, MD., MPH.
National Center for Advancing Translational Sciences (NCATS)
Telephone: 301-827-2014
Email: [email protected] 

Thomas Radman, PhD.
National Center for Advancing Translational Sciences (NCATS)
Telephone: 301-443-9375
Email: [email protected]

Victor Henriquez, Ph.D.
National Center for Advancing Translational Sciences (NCATS)
Telephone: 301-435-0813
Email: [email protected] 

Nichol Cleveland, M.Ed.
National Center for Advancing Translational Sciences (NCATS)
Telephone: 301-451-6331
Email: [email protected] 

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.

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 2 CFR Part 200.