The purpose of the Ruth L. Kirschstein National Research Service Award (NRSA) Individual Predoctoral (Parent F31) award is to enable promising predoctoral students will obtain individualized, mentored research training from outstanding faculty sponsors while conducting dissertation research projects in scientific health-related fields relevant to the missions of the participating NIH Institutes and Centers. The proposed mentored research training must reflect the candidates dissertation research project and is expected to clearly enhance the individuals potential to develop into a productive, independent research scientist. This Notice of Funding Opportunity (NOFO) does not allow candidates to propose to lead an independent clinical trial but does allow candidates to propose research experience in a clinical trial led by a sponsor or co-sponsor.

PA-25-422: Ruth L. Kirschstein National Research Service Award (NRSA) Individual Predoctoral Fellowship (Parent F31)

Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s) National Institutes of Health (NIH)

Components of Participating Organizations

• NATIONAL INSTITUTES OF HEALTH (NIH)
• National Eye Institute (NEI)
• National Heart, Lung, and Blood Institute (NHLBI)
• National Human Genome Research Institute (NHGRI)
• National Institute on Aging (NIA)
• National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• National Institute of Allergy and Infectious Diseases (NIAID)
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
• National Institute of Biomedical Imaging and Bioengineering (NIBIB)
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• National Institute on Deafness and Other Communication Disorders (NIDCD)
• National Institute of Dental and Craniofacial Research (NIDCR)
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• National Institute on Drug Abuse (NIDA)
• National Institute of Environmental Health Sciences (NIEHS)
• National Institute of Neurological Disorders and Stroke (NINDS)
• National Institute of Nursing Research (NINR)
• National Institute on Minority Health and Health Disparities (NIMHD)
• National Library of Medicine (NLM)
• National Center for Complementary and Integrative Health (NCCIH)
• National Cancer Institute (NCI)
• National Institute of Mental Health (NIMH), June 18, 2025 - Participation added (NOT-MH-25-215)
• National Institute of General Medical Sciences (NIGMS), March 19, 2026 - Participation added (NOT-GM-26-002)

All applications to this funding opportunity announcement should fall within the mission of the Institutes/Centers. The following NIH Offices may co-fund applications assigned to those Institutes/Centers:

• Office of Data Science Strategy (ODSS)

Funding Opportunity Title Ruth L. Kirschstein National Research Service Award (NRSA) Individual Predoctoral Fellowship (Parent F31)

Activity Code F31

Predoctoral Individual National Research Service Grant Award

Announcement Type Reissue of PA-23-272

Related Notices See Notices of Special Interest associated with this funding opportunity

• March 19, 2026 - Notice of NIGMS Participation in PA-25-422 "Ruth L. Kirschstein National Research Service Award (NRSA) Individual Predoctoral Fellowship (Parent F31)". See Notice NOT-GM-26-002.
• November 24, 2025 - Notice of Rescheduled NIDCR Pre-Application and Technical Assistance Webinars on Applying for Fellowship (F) Awards and Career Development (K) Awards. See Notice NOT-DE-26-013.
• September 25, 2025 - Notice of NIDCR Pre-Application and Technical Assistance Webinars on Applying for Fellowship (F) Awards and Career Development (K) Awards. See Notice NOT-DE-26-012.
• June 18, 2025 - Notice of NIMH Participation in PA-25-422, Ruth L. Kirschstein National Research Service Award (NRSA) Individual Predoctoral Fellowship (Parent F31). See Notice NOT-MH-25-215.
• June 17, 2025 - NOTICE OF CORRECTION: Eligible Individuals, Ruth L. Kirschstein Research Service Award (NRSA) Fellowships. See Notice NOT-OD-25-126.
• 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) PA-25-422

Companion Notice of Funding Opportunity None

Number of Applications See Section III. 3. Additional Information on Eligibility.

Assistance Listing Number(s) 93.173, 93.846, 93.398, 93.879, 93.273, 93.310, 93.855, 93.307, 93.286, 93.847, 93.867, 93.853, 93.361, 93.279, 93.865, 93.837, 93.838, 93.839, 93.840, 93.233, 93.172, 93.121, 93.866, 93.113, 93.213, 93.242, 93.859

Funding Opportunity Purpose The purpose of the Ruth L. Kirschstein National Research Service Award (NRSA) Individual Predoctoral (Parent F31) award is to enable promising predoctoral students to obtain individualized, mentored research training from appropriate faculty sponsors while conducting biomedical research in scientific health-related fields relevant to the missions of the participating NIH Institutes and Centers. The proposed mentored research training must address the candidate’s identified research training and career goals and enhance the candidate's potential to successfully transition to the next phase of their biomedical research career.

This Notice of Funding Opportunity (NOFO) does not allow fellowship candidates to propose to lead an independent clinical trial, but does allow candidates to propose research experience in a clinical trial led by a sponsor or co-sponsor.

Funding Opportunity Goal(s) The goals of the NOFO are to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability.

Key Dates

• Posted Date: June 13, 2025
• Open Date (Earliest Submission Date): July 08, 2025

The following table includes NIH standard due dates marked with an asterisk.

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

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

• Expiration Date: May 08, 2028

Due Dates for E.O. 12372 Not Applicable

Required Application Instructions It is critical that candidates follow the Fellowship (F) instructions in the How to Apply - Application Guide, except where instructed to do otherwise (in this NOFO or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the How to Apply - Application Guide and the NOFO) is required and strictly enforced. Candidates must read and follow all application instructions in the How to Apply - Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the How to Apply - 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.
• 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. Funding Opportunity Description
  • Section II. Award Information
    • Other Award Budget 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. Funding Opportunity Description

The overall goal of the NIH Ruth L. Kirschstein National Research Service Award (NRSA) program is to help ensure a highly trained, heterogenous pool of scientists is available in appropriate scientific disciplines to address the Nation's biomedical, behavioral, and clinical research needs. NRSA fellowships support the training of pre- and postdoctoral scientists, dual-degree investigators, and senior researchers.

More information about NRSA programs may be found at the NIH Research Training and Career Development website.

Note: This Notice of Funding Opportunity (NOFO) does not allow candidate to propose to lead an independent clinical trial, but does allow applicants to propose research experience in a clinical trial led by a sponsor or co-sponsor.

The purpose of the Ruth L. Kirschstein National Research Service Award (NRSA) Individual Predoctoral Fellowship (Parent F31) is to enable promising predoctoral students to obtain individualized, mentored research training from appropriate faculty sponsors while conducting biomedical research. Candidates for this F31 program are expected to propose a research project and training plan in scientific health-related fields relevant to the mission of the participating Institutes and Centers. This training plan should reflect the candidate’s research training project, and facilitate and clearly enhance the individual’s potential to develop the necessary skills for further career advancement. The training plan should document the need for, and the anticipated value of, the proposed mentored research and training in relationship to the individual’s research career goals. The training plan should also facilitate the fellow’s transition to the next stage of their research career. The research and training plans are expected to provide the candidate with a strong understanding of the rigorous research design, experimental methods, quantitative approaches, and data analysis.

It is expected that the mentored research training experience will provide:

• A strong foundation in rigorous research design, experimental methods, and analytic techniques appropriate to the proposed dissertation research;
• The enhancement of the candidate's ability to conceptualize and think through research problems with increasing independence;
• Experience conducting research using appropriate, state-of-the-art methods, as well as presenting and publishing the research findings as first author;
• The opportunity to interact with members of the scientific community at appropriate scientific meetings and workshops;
• Skills needed to transition to the next stage of the candidate's research career; and
• The opportunity to enhance the candidate's understanding of the health-related sciences and the relationship of the proposed research to health and disease.

Although candidates may work with their institutions to develop an application in support of their research training at any time, applications are encouraged once a candidate has identified a specific research project that will be undertaken, under the supervision of a sponsor in the sponsor's laboratory. This often occurs in the second year of a PhD program.

Note: This Notice of Funding Opportunity (NOFO) is designed specifically for candidates proposing research that does not involve leading an independent clinical trial, a clinical trial feasibility study, or an ancillary clinical trial, but does allow candidates to propose research experience in a clinical trial led by a sponsor or co-sponsor.

Special Note: Because of the differences in individual Institute and Center (IC) program requirements for this announcement, prospective candidates are strongly encouraged to consult the Table of IC-Specific Information, Requirements and Staff Contacts, to make sure that their application is appropriate for the requirements of one of the participating NIH ICs.

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

Section II. Award Information

Funding Instrument 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

• New
• Renewal - Individual fellowship awards are generally not renewable. In rare cases in which fellowship awardees require further fellowship support, they should consult with NIH staff to obtain advice regarding submission of a renewal application
• Resubmission

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.

Clinical Trial? Not Allowed: Only accepting applications that do not propose independent clinical trials.

Note: Candidates may propose to gain experience in a clinical trial led by a sponsor/co-sponsor as part of their research training.

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.

Award Budget Award budgets are composed of stipends, tuition and fees, and institutional allowance, as described below.

Award Project Period Individuals may receive up to 5 years of aggregate Kirschstein-NRSA support at the predoctoral level (up to 6 years for dual degree training, e.g., MD/PhD), and up to 3 years of aggregate Kirschstein-NRSA support at the postdoctoral level, including any combination of support from institutional training grants (e.g., T32) and an individual fellowship award.

Other Award Budget Information

• Stipends: Kirschstein-NRSA awards provide stipends as a subsistence allowance to help defray living expenses during the research and clinical training experiences. See https://researchtraining.nih.gov/resources/policy-notices. Award recipients in the NIH intramural program will be supported by intramural funds provided by the NIH Institute/Center intramural laboratory in which they are conducting their research.
• Tuition and Fees: Fellowship awards will contribute to the combined cost of tuition and fees at the rate in place at the time of award. See https://researchtraining.nih.gov/resources/policy-notices.
• Institutional Allowance: The application should request a Kirschstein-NRSA institutional allowance to help defray the cost of fellowship expenses such as health insurance, research supplies, equipment, books, and travel to scientific meetings. See https://researchtraining.nih.gov/resources/policy-notices.
• Indirect Costs: Fellowship awards do not include a separate reimbursement for indirect costs (also known as Facilities & Administrative [F&A] Costs). Instead of costs for administering fellowships are covered by the Institutional Allowance. See https://researchtraining.nih.gov/resources/policy-notices.

Stipend levels, as well as funding amounts for tuition and fees and the institutional allowance are announced annually in the NIH Guide for Grants and Contracts, and are also posted on the Ruth L. Kirschstein National Research Service Award (NRSA) webpage.

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

Eligible Organizations

• Higher Education Institutions - Includes all types
  • 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
  • Small Businesses
  • For-Profit Organizations (Other than Small Businesses)
• Governments
  • Eligible Agencies of the Federal Government
• Other
  • Non-domestic (non-U.S.) Entities (Foreign Organizations)

Before submitting a fellowship application, the candidate must identify a sponsoring organization. The sponsoring organization must have staff and facilities available on site to provide a suitable environment for performing the research training described within the application. The training should occur in an environment that has appropriate human and technical resources and is demonstrably committed to training in the field(s) proposed by the candidate. The sponsoring organization may be private (profit or nonprofit) or public, including the NIH Intramural Programs and other Federal laboratories. All organizations with the appropriate resources and commitment are encouraged to apply.

An individual may request support for training abroad. In such cases, the candidate is required to provide detailed justification for the foreign training, including the reasons why the facilities, the sponsor, or other aspects of the proposed experience are more appropriate than training in a domestic setting. The justification is evaluated in terms of the scientific advantages of the foreign training as compared to the training available domestically. Foreign training will be considered for funding only when the scientific advantages are clear.

Foreign Organizations

• Non-domestic (non-U.S.) Entities (Foreign Organizations) are eligible to apply.
• Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.
• Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Required Registrations

• Applicant Organizations: Applicant organizations must complete and maintain the following registrations as described in the 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 applicant organizations 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 NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications for additional information.

  • System for Award Management (SAM): Applicant organizations 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 registration; 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: Applicant organizations 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.
  • All PD(s)/PI(s) must be registered with ORCiD. The personal profile associated with the PD(s)/PI(s) eRA Commons account must be linked to a valid ORCID ID. For more information on linking an ORCID ID to an eRA Commons personal profile see the ORCID topic in our eRA Commons online help.

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: 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).
• Duration of Support: Individuals may not exceed the aggregate limit of NRSA support shown above in the Award Project Period (see Section II. Award Information). Candidates must consider any prior NRSA research training in determining the duration of support requested. Information regarding previous Kirschstein-NRSA support must be included in the application and will be considered at the time of award.
• Level of Effort: At the time of award, individuals are required to pursue their research training on a full-time basis, normally defined as 40 hours per week or as specified by the sponsoring organization in accordance with its own policies.
• Sponsor: Before submitting the application, the candidate must identify a sponsor(s) who will supervise the proposed mentored training experience. Candidates are encouraged to identify more than one sponsor, i.e., a sponsor team, if this is deemed advantageous for their training program. When there is a sponsor team, one individual must be identified as the primary sponsor, and will be expected to coordinate the candidate's overall training. The primary sponsor should be committed both to the candidate's research training plan and to the direct supervision of their research training project. The candidate must work with the primary sponsor(s) in preparing the application.

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 applicant organizations and fellowship candidates follow the Fellowship (F) 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 How to Apply - Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Page Limitations 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.

• 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.
• SF424(R&R) Senior/Key Person Profile Expanded: All instructions in the How to Apply - Application Guide must be followed.
  • IMPORTANT REMINDER: The personal profile associated with the eRA Commons username entered in the Credential field for the PD/PI (fellowship candidate) must include an ORCID ID. For more information on linking an ORCID ID to an eRA Commons personal profile see the ORCID topic in our eRA Commons online help.
• PHS Fellowship Supplemental Form: The PHS Fellowship Supplemental Form is comprised of the following sections:
  • Candidate Section
  • Research Training Plan
  • Commitment to Candidate, Mentoring, and Training Environment
  • Other Research Training Plan Sections
  • Additional Information
  • Budget
  • Appendix All instructions in the How to Apply - Application Guide must be followed.
  • Candidate Section: Goals, Preparedness, and Potential - All instructions in the How to Apply-Application Guide must be followed, with the following additional instructions:
  • Research Training Plan: Research Training Project Specific Aims and Strategy - All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:
  • Commitment to Candidate, Mentoring and Training Environment: All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions: If the candidate is proposing to gain experience in a clinical trial as part of his or her research training, the sponsor or co-sponsor must include a statement to document leadership of the clinical trial including source of funding, NCT# and appropriate expertise to guide the candidate in any proposed clinical trials research experience. The individual receiving support for the clinical trial (i.e., the sponsor/primary mentor or a co-sponsor) is the responsible individual of record for oversight of the trial though fellows can take part in all components of a clinical trial. Oversight includes (but is not limited to): interacting with relevant Institutional Review Board (IRB) staff; reviewing all informed consent documents; reporting potential serious adverse events; and maintaining responsibility for patient safety. However, the fellow can gain experience in all these components in conjunction with the mentor or individual leading the trial.
• Appendix: Limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the How to Apply - Application Guide; any instructions provided here are in addition to the How to Apply - Application Guide instructions.
• 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.
    • Do not provide an NCT# in Section 1, item 1.5. See instruction for Sponsor(s), Collaborator(s), and Consultant(s) above.
    • Do not complete Section 4 - Protocol Synopsis information or Section 5 - Other Clinical Trial-related Attachments.
  • 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.
• Reference Letters: Applicant organizations must carefully follow the How to Apply - Application Guide, including the time period for when reference letters will be accepted. Applications lacking the appropriate required reference letters will not be reviewed. This is a separate process from submitting an application electronically. Reference letters are submitted directly through the eRA Commons Submit Reference Letter link and not through Grants.gov.
• Foreign Organizations: Foreign (non-U.S.) organizations must follow policies described in the NIH Grants Policy Statement, and procedures for foreign organizations described throughout the How to Apply - Application Guide.

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. Applicant organizations 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). Applicant organizations 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.

Applicant organizations 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. The National Research Service Award (NRSA) policies apply to this program. A Kirschstein-NRSA fellowship may not be held concurrently with another federally sponsored fellowship or similar Federal award that provides a stipend or otherwise duplicates provisions of this award.

Pre-award costs are generally not allowable for Fellowships.

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.
• Applicant organizations 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) and sponsor(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.
• 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. Applications that are incomplete or non-compliant will not be reviewed.

Mandatory Disclosure 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 Applicant organizations are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

Overall Impact Reviewers will provide an overall impact score to reflect their assessment of the likelihood that the fellowship will enhance the candidate’s potential for, and commitment to, a productive independent scientific research career in a health-related field, in consideration of the scored and additional review criteria.

Score the overall merits of the application. Use the three review criteria areas defined below to evaluate the proposed fellowship application.

Scored Review Criteria Evaluate the overall merit of the application considering the three review criteria areas defined below. For each criteria area, provide a score and comments addressing the elements listed.

• Candidate's Goals, Preparedness and Potential:
  • Discuss the candidate's previous educational, scientific and professional experience in terms of how it prepares the candidate for the proposed research training plan. Consider the context, for example, the candidate's stage of training and the opportunities available.
  • Assess whether the candidate and sponsor statements as well as the referee letters provide convincing evidence that the candidate possesses qualities (such as scientific understanding, creativity, curiosity, resourcefulness and drive) that will improve the likelihood of a successful research training outcome.
  • Consider the candidate's potential to benefit from the fellowship research training plan and to transition to the next career stage in the biomedical research workforce.
• Research Training Plan:
  • Assess the rigor and feasibility of the research training project and how completion of the project will contribute to the development of the candidate as a research scientist.
  • Evaluate the goals of the overall research training plan and the extent to which the plan will facilitate the attainment of the goals.
  • Discuss whether the research training plan identifies areas of needed development and contains appropriate, realistic activities and milestones to address those needs.
  • Consider whether the sponsor(s), scientific environment, facilities and resources are adequate and appropriate for the proposed research training plan.
  • If the candidate is proposing to gain experience in a clinical trial as part of his or her research training, is there evidence of the appropriate expertise, experience, resources, and ability on the part of the sponsor(s) to guide the applicant during the clinical trial research experience?
• Commitment to Candidate, Mentoring and Training Environment:
  • Assess whether the sponsor(s) presents a strong mentoring plan appropriate to the needs and goals of the candidate.
  • Evaluate the extent to which the sponsor(s) and organizational commitment is appropriate, sufficient and in alignment with the candidate's research training plan.
  • Consider whether the level of the commitment provided will contribute to the successful completion of the proposed plan and allow the candidate to advance to a productive career in the biomedical research workforce.
  • If proposed, will the clinical trial experience contribute to the proposed project and/or the candidate's research training?

Additional Review Criteria As applicable for the project proposed, reviewers will evaluate the following items while determining merit, and in providing an overall impact score, but will not give separate scores for these items.

• Protections for Human Subjects: For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials. For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.
• Inclusion of Human Subjects Policies: When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for inclusion. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.
• Vertebrate Animals: The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following three points: (1) a complete description of all proposed procedures including the species, strains, ages, sex, and total numbers of animals to be used; (2) justifications that the species is appropriate for the proposed research and why the research goals cannot be accomplished using an alternative non-animal model; and (3) interventions including analgesia, anesthesia, sedation, palliative care, and humane endpoints that will be used to limit any unavoidable discomfort, distress, pain and injury in the conduct of scientifically valuable research. Methods of euthanasia and justification for selected methods, if NOT consistent with the AVMA) Guidelines for the Euthanasia of Animals, is also required but is found in a separate section of the application. For additional information on review of the Vertebrate Animals Section, please refer to the Worksheet for Review of the Vertebrate Animals Section.
• Biohazards: Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
• Resubmissions: For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.
• Renewals: Individual fellowship awards are generally not renewable. In rare cases in which fellowship recipients require further fellowship support, the committee will consider the progress made in the last funding period.
• Revisions: Not Allowed

Additional Review Considerations As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

• Training in the Responsible Conduct of Research: All applications for support under this NOFO must include a plan to fulfill NIH requirements for Instruction in the Responsible Conduct of Research (RCR). Taking into account the level of experience of the candidate, including any prior instruction or participation in RCR as appropriate for the candidate’s career stage, the reviewers will evaluate the adequacy of the proposed RCR training in relation to the following five required components: 1) Format - the required format of instruction, i.e., face-to-face lectures, coursework, and/or real-time discussion groups (a plan with only on-line instruction is not acceptable); 2) Subject Matter - the breadth of subject matter, e.g., conflict of interest, authorship, data management, human subjects and animal use, laboratory safety, research misconduct, research ethics; 3) Faculty Participation - the role of the sponsor(s) and other faculty involvement in the fellow’s instruction; 4) Duration of Instruction - the number of contact hours of instruction (at least eight contact hours are required); and 5) Frequency of Instruction – instruction must occur during each career stage and at least once every four years. Plans and past record will be rated as ACCEPTABLE or UNACCEPTABLE, and the summary statement will provide the consensus of the review committee. See also: NOT-OD-10-019 and NOT-OD-22-055.
• Applications from Foreign Organizations: Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.
• Select Agent Research: Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
• Resource Sharing Plans: Reviewers will comment on whether the Resource Sharing Plan(s) (e.g., Sharing Model Organisms) or the rationale for not sharing the resources, is reasonable.
• Authentication of Key Biological and/or Chemical Resources: For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.
• Budget and Period of Support: Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), convened by CSR, in accordance with NIH peer review policies and practices, 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 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 NIH Institute or Center. The following will be considered in making funding decisions:

• 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 their 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 recipient 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.

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

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.
• 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.
• Pursuant to the Cybersecurity Act of 2015, Div. N, § 405, Pub. Law 114-113, 6 USC § 1533(d), the HHS Secretary has established a common set of voluntary, consensus-based, and industry-led guidelines, best practices, methodologies, procedures, and processes.

Successful recipients under this NOFO agree that: When recipients, subrecipients, or third-party entities have: * ongoing and consistent access to HHS owned or operated information or operational technology systems; and * receive, maintain, transmit, store, access, exchange, process, or utilize personal identifiable information (PII) or personal health information (PHI) obtained from the awarding HHS agency for the purposes of executing the award. Recipients shall develop plans and procedures, modeled after the NIST Cybersecurity framework, to protect HHS systems and data. Please refer to NIH Post-Award Monitoring and Reporting for additional information.

The taxability of stipends is described in the NIH Grants Policy Statement.

Inventions and Copyrights Fellowships funded primarily for educational purposes are exempted from the PHS invention requirements and thus invention reporting is not required. More details, including exceptions for fellows training at NIH are provided in the NIH Grants Policy Statement.

3. Data Management and Sharing

Not applicable

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.

Other Fellowship Reporting Requirements:

• Individuals admitted to the United States as Permanent Residents must submit notarized evidence of legal admission prior to the award.
• The fellowship award recipient has up to six months from the issue date on the Notice of Award to activate the award using the Kirschstein-NRSA Individual Fellowship Activation Notice (PHS 416-5). Under unusual circumstances, the activation period may be extended at the request of the fellow. Such a request must be countersigned by the sponsor and an authorized institutional official.
• For the individual's initial 12 months of Kirschstein-NRSA postdoctoral support, a signed, original Payback Agreement Form (PHS 6031) must accompany the Activation Notice.
• At the conclusion of a fellowship, the fellow must submit a Termination Notice (PHS 416-7) via xTrain to the NIH within 30 days of termination. Fellows with service payback requirements must notify the NIH of any change in address and submit Annual Payback Activities Certification Forms (PHS 6031-1) until the payback service obligation is satisfied.

5. Evaluation

In carrying out its stewardship of human resource-related programs, NIH may request information essential to an assessment of the effectiveness of this program from databases and from participants themselves. Participants may be contacted after the completion of this award for periodic updates on various aspects of their employment history, publications, support from research grants or contracts, honors and awards, professional activities, and other information helpful in evaluating the impact of the program.

Section VII. Agency Contacts

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

Because of the difference in individual Institute and Center (IC) program requirements for this NOFO, prospective applications MUST consult the Table of IC-Specific Information, Requirements, and Staff Contacts, to make sure that their application is responsive to the requirements of one of the participating NIH ICs. Prior consultation with NIH staff is strongly encouraged.

Application Submission Contacts

• eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)
  • Finding Help Online: 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: 301-637-3015
• Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
  • Contact Center Telephone: 800-518-4726
  • Email: [email protected]

Scientific/Research Contact(s) See Table of IC-Specific Information, Requirements, and Staff Contacts

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

Financial/Grants Management Contact(s) See Table of IC-Specific Information, Requirements, and Staff Contacts

Section VIII. Other Information

Recently issued NIH-wide 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.

Please note that the NIH Loan Repayment Programs (LRPs) are a set of programs to attract and retain promising early-stage investigators in research careers by helping them to repay their student loans. Recipients of fellowship awards are encouraged to consider applying for an extramural LRP award.

Authority and Regulations Awards are made under the authorization of Section 487 of the Public Health Service Act as amended (42 USC 288) and under Federal Regulations 42 CFR 66.

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