Limited Competition: Small Grant Program for the NCATS Clinical and Translational Science Award (CTSA) Program (R03 Clinical Trial Optional) is sponsored by National Institutes of Health (NIH). Supports small, discrete, well-defined research projects that can be completed in a short period with limited resources, specifically for the NCATS Clinical and Translational Science Award (CTSA) Program.

PAR-25-155: Limited Competition: Small Grant Program for the NCATS Clinical and Translational Science Award (CTSA) Program (R03 Clinical Trial Optional) This funding opportunity was updated to align with agency priorities. Carefully reread the full funding opportunity and make any needed adjustments to your application prior to submission. Department of Health and Human Services Part 1.

Overview Information Participating Organization(s) National Institutes of Health ( NIH ) Components of Participating Organizations National Center for Advancing Translational Sciences ( NCATS ) Funding Opportunity Title Limited Competition: Small Grant Program for the NCATS Clinical and Translational Science Award (CTSA) Program (R03 Clinical Trial Optional) March 31, 2025 - This funding opportunity was updated to align with agency priorities.

Carefully reread the full funding opportunity and make any needed adjustments to your application prior to submission. April 4, 2024 - Overview of Grant Application and Review Changes for Due Dates on or after January 25, 2025. See Notice NOT-OD-24-084 .

August 31, 2022 - Implementation Changes for Genomic Data Sharing Plans Included with Applications Due on or after January 25, 2023. See Notice NOT-OD-22-198 . August 5, 2022 - Implementation Details for the NIH Data Management and Sharing Policy.

See Notice NOT-OD-22-189 . Funding Opportunity Number (FON) Companion Funding Opportunity See Section III. 3.

Additional Information on Eligibility . Assistance Listing Number(s) Funding Opportunity Purpose This is a limited competition. The purpose of this NOFO is to enhance the capability of NCATS CTSA Program KL2/K12 scholars supported by the CTSA Program to conduct translational science research as they complete the transition to fully independent academic translational scientists.

These R03 grants will support different clinical and translational science research projects, including pilot and feasibility studies; secondary data analysis of existing data; small, self-contained research projects; development of research methodology; and development of new research technology. Research proposed in the R03 application may or may not include patient-oriented research.

The R03 is, therefore, intended to support research projects that can be carried out in a short period of time with limited resources and that provide preliminary data to support submission of a subsequent R01, or equivalent, application.

Open Date (Earliest Submission Date) Renewal / Resubmission / Revision (as allowed) AIDS - New/Renewal/Resubmission/Revision, as allowed 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.

Required Application Instructions 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.

Use the NIH ASSIST system to prepare, submit and track your application online. 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. Workspace to prepare and submit your application and eRA Commons to track your application. Part 1.

Overview Information 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 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.

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 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. 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 Grant: A financial assistance mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed Resubmission - Resubmission of Applications submitted to PAR-24-042 and this NOFO The OER Glossary and the How to Apply Application Guide provide details on these application types. Only those application types listed here are allowed for this NOFO. Optional: Accepting applications that either propose or do not propose clinical trial(s).

Need help determining whether you are doing a clinical trial? Funds Available and Anticipated Number of Awards The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications. Application budgets are limited to direct costs up to $50,000 per year and need to reflect the actual needs of the proposed project.

The scope of the proposed project should determine the project period. The maximum period of support is 2 years. NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this NOFO.

Section III.

Eligibility Information Higher Education Institutions Public/State Controlled Institutions of Higher Education Private Institutions of Higher Education 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 (Other than Small Businesses) City or Township Governments Special District Governments Indian/Native American Tribal Governments (Federally Recognized) Indian/Native American Tribal Governments (Other than Federally Recognized).

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

Eligible Individuals (Program Director/Principal Investigator) Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with their organization to develop an application for support.

Eligibility is limited to NCATS CTSA Program supported: 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. 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. KL2/K12 scholars funded 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.

Applications must be submitted for R03 due dates within 2 years of completion of the KL2/K12 appointment. 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. 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 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. All page limitations described in the How to Apply- Application Guide and the Table of Page Limits must be followed. Instructions for Application Submission 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.

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 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: Applications must include a brief summary of the applicant's funded KL2/K12 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 award, if applicable, and how the R03 project diverges from the KL2/K12 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 awardee toward research independence.

Recently completed NCATS CTSA Program KL2/K12 award recipients: Applications must include a brief summary of both their KL2/K12 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 award, if applicable, and how the R03 project diverges from the completed KL2/K12 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 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. 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.

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.

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.

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

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.

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.

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.

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.

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. 7. Other Submission Requirements and Information 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. 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,