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

Background

Biomedical translation leverages a process of turning observations from the laboratory, clinic and community into interventions that improve the health of individuals and the public — from diagnostics and therapeutics to medical procedures and behavioral changes. Each research stage across the translational spectrum from target validation through intervention development to public health benefit assessment, is currently fraught with inefficiency and in need of bold, new, innovative solutions. Thus, there has remained a need for bold, new, innovative experimental approaches to identifying such solutions. 

Translational Science, a field dedicated to optimizing biomedical translation, is aimed at generating scientific and operational innovations that overcome longstanding challenges along the translational research pipeline. The Translational Science approach is not to focus on specific diseases, but on what is common among them including: scientific and operational innovations that can be applied across diseases; for developing and applying new research approaches, technologies, resources, and/or models; for demonstrating their usefulness; and for disseminating the data, analysis and methodologies to the community. 

The National Center for Advancing Translational Sciences (NCATS) at the National Institutes of Health (NIH), leverages Translational Science innovations to advance progress along the translational pathway. Ultimately, to lead to more treatments for all people more quickly. Indeed, NCATS strives to develop innovations to reduce, remove or bypass costly and time-consuming bottlenecks in the translational research pathway in an effort to speed the delivery of new drugs, diagnostics and medical devices to patients. NCATS' catalysis of the development, demonstration, and dissemination of innovations across the spectrum of translational science will advance its mission to transform the effectiveness of translation of discoveries from the laboratory, clinic, and community into tangible benefits to human health. 

The NCATS Translational Science Principles characterize effective approaches for translation, and exemplify NCATS’ core approaches for advancing translational progress. These principles are described on the NCATS website at - https://ncats.nih.gov/training-education/translational-science-principles.The principles are intentionally broad and apply to research anywhere along the translational continuum. While they exemplify translational science approaches, they are not intended to be comprehensive. 

Purpose

This is a limited competition. The purpose of this notice of funding opportunity (NOFO) is to support small self-contained translational science research projects that may be carried out in a short period of time with limited resources and are expected to 1) address a general roadblock in science and/or operations that limits the efficiency and effectiveness of translation; 2) develop, demonstrate, and/or disseminate innovative solutions and/or new or better treatments that will have an impact on improving the health of patients; and 3) provide outcomes and preliminary data likely to serve as the basis for the transition of clinical and translational scientists to fully independent academic translational scientists. There is not an expectation that projects supported by the NOFO will likely "move the field forward" at this stage. Yet within the context of the NCATS approach and focus on translational science, the results of a project responsive to this NOFO would be expected to be translated to one or more diseases and/or generalizable. 

The NOFO will support Small Grant Program (R03) applications from NCATS Clinical and Translational Science Award (CTSA) Program’s KL2/K12 scholars and supplement recipients whom have been recently supported directly by the CTSA Program. Applications must be submitted for R03 due dates within 2 years of completion of the KL2/K12 appointment or research supplement. Complete eligibility details are described below (Section III. Eligibility Information).

By providing this funding, the NCATS CTSA Program intends to foster the successful development of the next generation of clinical and translational science leaders trying to launch their independent research careers by augmenting previous investments. This grant support by the CTSA Program is expected to have the following benefits: 

• An opportunity for the recipient to demonstrate additional success in the NIH peer review process 
• An opportunity for the recipient to generate new data, increase scientific output, and/or identify a path forward (new collaboration, clinical trial, Investigational New Drug (IND) application, partnership with a company, etc.) for the clinical and translational science research project 
• An opportunity to prepare and submit a subsequent R01, or equivalent, application. 

Projects supported under this NOFO may include, but are not limited to: 

• Conduct of pilot and feasibility studies; secondary data analysis of existing data; small, self-contained research projects; software or app development, t, that would support the catalysis of a tangible scientific outcome or result in a change in approach ("fast-fail"). 
• Development of new research technology, method or approach that addresses a general roadblock in science and/or operations that limits the efficiency and effectiveness of translation. 
• Demonstration in one or more use cases whether the tool, method, or approach is effective in accelerating research translation, utilizing clear and meaningful metrics and outcomes. 

Examples include, but are not limited to:

• Community engagement methods and technologies that increase the efficiency and effectiveness of intervention development and deployment, and measurement of their effects on improving health outcomes. Community engagement should be defined broadly to include local and distributed, physical and virtual communities.
• Development of transformative technologies (such as digital health, telehealth, data science, artificial intelligence, machine learning) to increase efficiency during implementation of clinical research studies or clinical trials (e.g., study site selection and activation, recruitment and retention, patient reported outcomes, biomarker identification and validation, data collection and analysis, risk communication, clinical monitoring, data and safety monitoring, interoperability of electronic health record systems and clinical research data management systems).
• Strategies to engage understudied/underreported populations in clinical research and clinical trials.
• Clinical, genetic or machine-learning approaches that speed the identification or accurate diagnosis of patients to shorten the diagnostic odyssey encountered by patients.
• Approaches that more rapidly identify the molecular underpinnings of genetic diseases and potential targets for therapeutics development, such as computationally-assisted modeling.
• Innovative applications and integration of data science, informatics tools and/or artificial intelligence/machine learning to make data more meaningful, open and accessible for the scientific community (predictive modeling, algorithms, simulation technologies, creation and dissemination of knowledge networks).
• Strategies or approaches to reduce the time to adoption of an intervention.

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 request support of clinical trials beyond Phase IIB, with the exception of Phase III (21 CFR definition) clinical trials for treatment of a rare disease or condition.

Clinical Trials Restriction

As detailed in NOT-TR-18-025, NCATS is limited to direct support of clinical trials through phase IIB with the exception of phase III (21 CFR definition) clinical trials for treatment of a rare disease or condition.

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

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 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.

Eligibility is limited to NCATS CTSA Program supported:

1) Scholars who received direct NCATS funding from the NCATS CTSA Program Institutional Career Development Core/Program (KL2/K12) and completed the KL2/K12 training program. Determination of eligibility will be based on the submitted and accepted KL2/K12 xTrain appointment forms. The expectation is that KL2/K12 scholars have completed the full mentored research career development program.

2) recipients of research supplements to promote diversity in health-related research supported by the CTSA Program (Research Supplements to Promote Diversity in Health-Related Research (Admin Supp - Clinical Trial Not Allowed) (PA-23-189 and PA-21-071)) that are at the level of investigators developing independent research careers; or

3) recipients of research supplements to promote re-entry into biomedical and behavioral research careers supported by the CTSA Program (Research Supplements to Promote Re-Entry, Re-integration into, and Re-training in Health-Related Research Careers (Admin Supp - Clinical Trial Not Allowed) (NOT-OD-21-134 and NOT-OD-23-170)).

Applications with multiple PDs/PIs will not be accepted. Only single PD/PI applications are allowed. Only the PD/PI may be listed as a Senior/Key Person and provide a Biographical Sketch.

Scholars funded by KL2/K12 supplements supported by other NIH ICs are not eligible (e.g. RFA-DE-17-008, PA-18-920, NOT-AT-20-010, PA-18-426, PA-18-851, NOT-OD-20-022, NOT-OD-21-001, NOT-OD-22-192). The earliest award date for the R03 is one day after the completion of the scholar’s appointment or one day after the completion of the research supplement award. Applications must be submitted for R03 due dates within 2 years of completion of the KL2/K12 appointment or the research supplement. Eligibility for resubmissions will be extended for 12 months past the first submission. PD/PIs who have already successfully competed for a substantial NIH independent research award are ineligible. An investigator will retain their eligibility if they have already successfully competed for any of the smaller research awards, training, infrastructure, and career awards that are listed here, provided that each application is scientifically distinct.

Applicants are strongly encouraged to consult with NCATS about their proposal early in the planning of an application; questions regarding eligibility should be addressed prior to beginning to prepare the application by contacting the Scientific/Research contact listed in Section VII. Agency Contacts.

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).

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:

The letter of intent should be sent to:
NCATS Letters of Intent
301-827-9549
[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.

Other Attachments:

The attachments listed below must be included in the application. Applications that fail to include the items listed below and to adhere to the specified page limits, will be deemed incomplete and will not be reviewed.

Summary of Research (up to 3 pages)

Current NCATS CTSA Program KL2/K12 scholars and supplement award recipients: Applications must include a brief summary of the applicant's funded KL2/K12 or supplement award. This attachment should be entitled "Summary.pdf" and will be reflected in the final image. Describe how the R03 application is informed by, or results from, the research supported by the KL2/K12 or supplement award, if applicable, and how the R03 project diverges from the KL2/K12 or supplement award. This attachment, combined with the information in the Research Strategy, should provide adequate explanation and justification documenting how the proposed R03 support will affect plans and enhance the advancement of the KL2/K12 or supplement awardee toward research independence.

Recently completed NCATS CTSA Program KL2/K12 or supplement award recipients: Applications must include a brief summary of both their KL2/K12 or supplement award as well as the applicant's current research efforts. This attachment should be entitled "Summary.pdf" and will be reflected in the final image. Describe how the R03 application is informed by, or results from, the research supported by the KL2/K12 or supplement award, if applicable, and how the R03 project diverges from the completed KL2/K12 or supplement award. This attachment, combined with the information in the Research Strategy, should provide adequate explanation and justification documenting how the proposed R03 support will affect plans and enhance the advancement of the KL2/K12 or supplement awardee toward research independence.

Eligibility Statement (no more than one page)

KL2/K12: Applications must include an Eligibility Statement that includes the KL2/K12 grant number, start date of the appointment and expected or actual end date of the appointment, and the number of years that the KL2/K12 program was designed to provide support for a scholar (2, 3, 4 or 5 years). The expectation is that KL2/K12 scholars have completed the full mentored research career development program.  If the term of appointment on the KL2/K12 was less than the number of years that the KL2/K12 program was designed to provide support indicate the reason and provide assurance that the scholar completed the program as designed (inclusive of acquiring core knowledge in clinical and translational science research, didactics, etc.). The Eligibility Statement must be a signed statement from the KL2/K12 PD/PI.  Determination of eligibility will be based on the submitted and accepted KL2/K12 xTrain appointment forms.

Diversity or Re-entry Supplement: Applications must include an Eligibility Statement that includes the supplement grant number, start date of the award and expected or actual end date of the award. The Eligibility Statement must be a signed statement from the CTSA hub PD/PI.

Translational Science Research Statement (no more than one page)

Applications must include a statement that describes the research project’s focus on a general roadblock in science and/or operations that limits the efficiency and effectiveness of translation. The Small Research Grant focused on translational science research would be expected to develop innovations that address persistent challenges to advancing translational progress that are found across multiple research initiatives or projects, or span research on multiple diseases or conditions.

SF424(R&R) Senior/Key Person Profile

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

R&R or Modular Budget

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

All awardees of this R03 program will be expected to present results and outcomes of their R03 projects in an annual meeting that will stimulate collaboration, fast adoption, and resource sharing. Applicants should include a budget for travel to this annual meeting of up to $1500.

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 project will 1) address a general roadblock in science and/or operations that limits the efficiency and effectiveness of translation; 2) develop, demonstrate, and/or disseminate innovative solutions and/or new or better treatments that will have an impact on improving the health of patients; and 3) support the transition of clinical and translational scientists to fully independent academic translational scientists by enabling them to acquire sufficient preliminary data for subsequent research applications.

Research Strategy

Current NCATS CTSA Program supported scholars and supplement awardees: Describe how this R03 application represents the next phase in your research or how it is related to, or resulted from, the research supported by the applicant's KL2/K12 or supplement award. Applicants should also provide a brief summary of the status of their career development. Describe the feasibility of the proposed research strategy for two years of work. Describe how the R03 will prepare the applicant to be competitive for future funding opportunities and provide a timeline for submission of an R01 or other independent research support.

Recently completed NCATS CTSA Program supported scholars and supplement awardees: Describe how this R03 application represents the next phase in your research or how it is related to, or resulted from, the research supported by the applicant's KL2/K12 or supplement award; provide a brief summary of how the R03 support will significantly enhance progress towards research independence. Describe the feasibility of the proposed research strategy for two years of work. Describe how the R03 will prepare the applicant to be competitive for future funding opportunities and provide a timeline for submission of an R01 or other independent research support.

For all applicants: If applicable and/or if the scholar or awardee is at an institution with a CTSA Program grant, describe how the core components or resources (such as biostatistics, epidemiology and research design (BERD), informatics, community engagement, regulatory knowledge and support, etc.) of the CTSA Program hub or the current institution are leveraged in support of this project.

Letters of Support:

The following letters of support must be included as a single Letter of Support attachment. Applications that do not contain the required letters of support will be considered incomplete and will not be reviewed.

• Mentor(s)' Letter of Support. A letter from the applicant's current or former mentor must be included. If there is more than one mentor, a single counter-signed letter is sufficient. It should address: the applicant's potential for a future, independent research career and the nature of the mentors(s)' continuing relationship with the applicant.
• Department/Division Head Letter of Support. A letter from the applicant's Department/Division Head must be included. It should address: the applicant's potential for a future, independent research career.
• Institutional Commitment to Applicant Letter of Support. A letter stating the Institution's commitment to the candidate must be included. The Institutional Commitment letter should include the following:
  • A statement from the sponsoring institution that it is committed to the candidate's development into a productive, independent investigator and to meeting the requirements of the award.
  • Assurance that the candidate will have use of office and laboratory space, equipment, and other resources to carry out the proposed research plan.

CTSA Program PI(s)' Letter of Support. If applicable and/or if the scholar or awardee is at an institution with a CTSA Program grant, a letter of support from the CTSA Program PI(s) must be included. It should describe the cores and resources that are being leveraged for the project (biostatistics, epidemiology, and research design (BERD), informatics, community engagement, regulatory knowledge and support, etc.).

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.

Other Plan(s): 

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

• 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, NIH, and responsiveness by NCATS, NIH. Applications that are incomplete, non-compliant, and/or nonresponsive will not be reviewed.

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.

For this particular announcement, note the following:

The R03 small grant supports discrete, well-defined projects that realistically can be completed in two years and that require limited levels of funding. Because the research project usually is limited, an R03 grant application may not contain extensive detail or discussion. Accordingly, reviewers should evaluate the conceptual framework and general approach to the problem. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or from investigator-generated data. Preliminary data are not required, particularly in applications proposing pilot or feasibility studies.

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. 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]

Patrick H. Brown, Ph.D.
National Center for Advancing Translational Sciences (NCATS)
Telephone: 301-435-1737
Email: [email protected] 

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

Zulema Eldridge, M.A.
National Center for Advancing Translational Sciences (NCATS)
Telephone: 301-443-3066
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.