Part 1. Overview Information

Key Dates

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.

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.

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

The overall goal of the NIH fellowship, research training, and career development programs is to help ensure a highly trained, heterogeneous pool of scientists is available across appropriate scientific disciplines to address the Nation's biomedical, behavioral, and clinical research needs. NIH fellowships support the training of predoctoral and postdoctoral scientists, dual-degree investigators, and senior researchers.  More information about these fellowships is available on the NIH Research Training and Career Development website.

Note: This Notice of Funding Opportunity (NOFO) does not allow candidates to propose leading an independent clinical trial. However, candidates may propose research experience in a clinical trial led by a sponsor or co-sponsor.

Purpose 

The purpose of the Predoctoral to Postdoctoral Transition Award (Parent F99/K00) is to support promising graduate students as they complete their doctoral research training and transition to mentored postdoctoral career development opportunities in research areas relevant to the mission of participating NIH Institutes and Centers (ICs), preparing them to become productive, independent researchers.

Award Structure

The F99/K00 provides up to 5 years of support across two consecutive phases.

• F99 Phase (Predoctoral): Provides 1 to 2 years of mentored research training to support completion of the research doctorate, including final experiments, dissertation preparation, and selection of a postdoctoral mentor. 
• K00 Phase (Postdoctoral): Provides up to 3 years of mentored postdoctoral research and career development support, contingent upon successful completion of the doctoral degree requirements and securing a postdoctoral position in a research area relevant to the mission of the participating NIH ICs. The K00 research direction should be within the mission area of the NIH IC that awarded the F99 phase. 

A K00 award will be made only to support a PD/PI who has successfully completed F99-supported training, secured a postdoctoral appointment, and, in coordination with the applicant institution, submitted to NIH a strong research and career development plan to be carried out in a supportive and rigorous research environment. Candidates are expected to obtain a postdoctoral position at an institution other than the one where they conducted their doctoral research.

Expectations

Predoctoral students applying for the F99/K00 award are expected to propose an individualized research training plan for the final 1 to 2 years of predoctoral training, as well as a broad outline of up to 3 years of mentored postdoctoral research and career development activities that will prepare them for a productive, independent scientific research career in a biomedically relevant field.

The mentored research training and career development experience is expected to provide:

• a strong foundation in rigorous research design, experimental methods, and analytical techniques appropriate to the proposed research;
• enhanced 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 research findings as first author;
• opportunities to interact with members of the scientific community at appropriate scientific meetings and workshops;
• professional and scientific skills needed to transition to the next stage of the candidate's research career; and
• opportunities to enhance and refine the candidate's understanding of the biomedical sciences and the relationship of the proposed research to health and disease.

The F99/K00 award is intended for individuals who require at least 12 months of mentored research training in the F99 phase before transitioning to the K00 phase. Accordingly, individuals should propose a well-conceived plan for 1 to 2 years of substantive mentored predoctoral research training that will help them become competitive for postdoctoral research positions. An individual who cannot provide a compelling rationale for at least one year of additional mentored predoctoral research training at the time of award is not a competitive candidate for this fellowship.

Additional Information

Because of the differences in individual Institute, Center, and Office (ICO) program requirements for this announcement, prospective candidates are strongly encouraged to consult the NIH Research Training and Career Development website to make sure that their application is appropriate for the requirements of one of the participating NIH ICOs.

Supported PD/PIs who can justify the need for additional mentored career development training beyond the K00 may work with their institutions to apply for additional NIH mentored career development awards.

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

Section II. Award Information

Other Award Budget Information

F99 Phase: Stipends are provided as a subsistence allowance to help defray living expenses during the research training experience. The stipend amount for F99 predoctoral fellows is the same as that for Ruth L. Kirschstein National Research Service Award (NRSA) predoctoral trainees and fellows. For details, see NRSA policy notices on the NIH Fiscal Policies website.

Award recipients in the NIH intramural program will be supported by intramural funds provided by the NIH Institute or Center (IC) intramural laboratory in which they are conducting their research.

K00 Phase: The participating NIH Institutes and Centers will provide salary and fringe benefits for the K00 award recipient. Candidates are encouraged to visit the NIH Research Training and Career Development website and consult with program officials from participating NIH institutes and centers for IC-specific award budget information. Further guidance on budgeting for career development salaries is provided in the How to Apply - Application Guide. 

F99 Phase: The application should request an institutional allowance to help defray the cost of fellowship expenses such as health insurance, research supplies, equipment, books, and travel to scientific meetings. The annual institutional allowance level for the F99 phase is the same as that provided for the F31 Ruth L. Kirschstein National Research Service Award (NRSA). For details, see the NIH Fiscal Policies website.

K00 Phase: Research development support may be requested to the level provided by the awarding NIH Institutes and Centers. Candidates should visit the NIH Research Training and Career Development webpage and consult with program officials for IC-specific, programmatic and budgetary information. Further guidance on budgeting for research development support is provided in the How to Apply - Application Guide. These funds may be used for the following expenses: (a) tuition and fees related to career development activities; (b) research-related expenses, such as supplies, equipment, and technical personnel; (c) travel to research meetings or training; and (d) statistical services including personnel and computer time.

Salary for mentors, secretarial and administrative assistants, etc. is not allowed.

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 NIH Fiscal Policies website.

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 - 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)

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

• None

F99 Eligibility: All institution/organization types listed above that grant PhD or equivalent research degrees (e.g., EngD, DNSc, DrPH, DSW, PharmD, ScD) are eligible to serve as a sponsoring institution.  The sponsoring institution must have staff and facilities available on site to provide a suitable environment for performing high-quality research training. 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. All organizations with the appropriate resources and commitment are encouraged to apply. Multiple applications from an institution are allowed.

NIH Intramural Programs and other Federal laboratories are eligible to submit applications for the F99 phase (see note below). 

K00 Eligibility: All institution/organization types listed above, with the exclusion of Federal laboratories, are eligible to submit K00 transition phase applications on behalf of individuals receiving support from F99 awards. There is no limit on the number of K00 awardees that an organization may sponsor. 

Note: If the F99 candidate accepts a postdoctoral position in the NIH intramural research program or another federal agency, the postdoctoral phase will then be supported directly by the federal agency offering the postdoctoral position. The K00 will not be awarded, as federal employees are not eligible for NIH extramural grants. These postdoctoral scholars are invited to continue to participate in any relevant programmatic opportunities offered by the participating NIH Institutes and Centers. 

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/International Collaborations

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.

NIH will no longer issue awards (i.e., new, renewal, or non-competing continuation) to domestic or foreign entities that involve foreign subawards/subcontracts. All NIH-funded research involving foreign subawards/subcontracts must be submitted in response to a NOFO that is specifically designated for funded international collaborations. See NIH Grants Policy Statement 16.8 Collaborative International Research Awards.

Applications involving foreign subawards/subcontracts submitted in response to this NOFO will be deemed noncompliant and will not be considered for funding. This policy applies to all monetary international collaborations resulting in foreign subawards/subcontracts, however, it does not preclude unfunded international collaborations or foreign components, funding for foreign consultants, or procurement of unique equipment or supplies from foreign vendors.

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) – 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. Foreign organizations must obtain a NATO Commercial and Government Entity (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.

Any candidate(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director/Principal Investigator (PD/PI) is invited to work with their sponsor and organization to develop an application for support. Multiple PDs/PIs are not allowed.

The candidate must be currently enrolled in a PhD or equivalent research degree program (e.g., EngD, DNSc, DrPH, DSW, PharmD, ScD) in the biomedical, behavioral, or clinical sciences at an eligible institution. 

By the time of award, the individual must be a citizen or a non-citizen national of the United States or have been lawfully admitted for permanent residence (i.e. possess a currently valid Permanent Resident Card USCIS Form I-551, or other legal verification of such status).

At the time of award, the candidate must be in the dissertation research stage of training and is expected to require 1–2 years to complete their Ph.D. dissertation research training (F99 phase) before transitioning to mentored postdoctoral research training (K00 phase). If an individual begins a postdoctoral position or completes all Ph.D. dissertation requirements before an F99 award is made, neither the F99 award nor the K00 award will be issued.

Clinical Training and Health Professional Degrees

Candidates must be enrolled in a research doctoral degree program that does not require post-degree clinical training. The Parent F99/K00 award may not be used to support studies leading to a MD, DDS, or other clinical, health-professional degree (e.g., DC, DMD, DNP, DO, DPM, DVM, ND, OD, AuD, PharmD, clinical PhD). The F99 and K00 phases are intended to be contiguous in time and cannot accommodate clinical training.

Dual-Degree Programs

Students matriculated in a dual-degree program (e.g. MD/PhD, DO/PhD, DDS/PhD, or DVM/PhD) who seek support for both dissertation research training and clinical training are not eligible for the F99/K00 program because the F99/K00 does not support the clinical training component. Exceptions may be considered if there is no gap between the doctoral research training and postdoctoral phase, i.e., there is no clinical training period between completion of the PhD and the start of the postdoctoral research position. Students matriculated in a dual-degree program without a gap between the completion of the PhD and the postdoctoral phase should contact the appropriate IC program officer for approval prior to submitting an application. Alternatively, such students may apply for the Ruth L. Kirschstein National Research Service Award (NRSA) Individual Predoctoral MD/PhD or Other Dual-Doctoral Degree Fellowship (Parent F30) to support both dissertation research training and clinical training.

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).

Concurrent support from multiple NIH/PHS individual fellowships and/or dissertation awards are prohibited.  

See Award Project Period in Section II. Award Information.

F99 Phase: 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.

K00 Phase: Individuals receiving support under a K00 are required to have a full-time appointment at the applicant institution, and to commit a minimum of 9 person-months (or 75% of their full-time professional effort at the applicant institution) to their career development and research training. K00 awardees may engage in other duties (e.g., other research, training, clinical and teaching activities) as part of the remaining 25% effort not covered by the award, as long as such duties do not interfere with or detract from the proposed career development program.

F99 Phase: The primary sponsor should be an active investigator in the area of the proposed research training and be committed both to the candidate's research training and to direct supervision of their research. The primary sponsor must document the availability of sufficient research funds and facilities for the proposed research training. The primary sponsor can be an independent investigator at any career stage, including an early-stage investigator. Regardless of career stage, the primary sponsor must demonstrate a commitment to ensuring the candidate receives tailored training that will facilitate their skills development and career advancement.  The candidate must work with the primary sponsor(s) in preparing the application.

K00 Phase: Candidates are not required to identify a sponsor for the K00 phase at the time of the initial F99/K00 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 (in this NOFO, in a policy notice, or other notice from NIH Guide for Grants and Contracts). 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.

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.

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

Certification Letter

Applicants are required to attach a letter from the institution certifying eligibility of the Fellowship applicant for this program. The certification letter must be on institutional letterhead and scanned so that an institutional official signature is visible. See instructions in the SF424 (R&R) Application Guide.

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

Specific to this NOFO, the following additional instructions apply:

Biographical Sketch:

PD/PI (fellowship candidate)

• In the "Professional Preparation" section of the Biographical Sketch Common Form, the start date (month and year) of all the candidate's education/training experiences must be included.
• In the "Personal Statement" section of the NIH Biographical Sketch Supplement, candidates should include a description of their career goals and their intended career trajectory. When relevant, candidates are encouraged to account for factors that affected past productivity. 

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.

Goals, Preparedness, and Potential

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

This section should address both phases of the F99/K00.

A. Overall Training Goals

• Describe the long-term research and career goals and explain how the F99/K00 will enable the attainment of those goals. For each phase, describe how the proposed research training and career development plan will enhance the candidate's knowledge, technical expertise, and professional skills, keeping in mind existing strengths as well as any gaps in existing skills. Candidates are encouraged to discuss their alignment with the mission(s) of at least one participating NIH Institute/Center (IC). Consult IC Strategic Plans and the NIH Research Training and Career Development website for information on IC missions and areas of interest.

B. Candidate's Preparedness

• Address preparation for both phases of the F99/K00.
• In this section, candidates may also provide an example of a challenge that they faced in research and have overcome using creativity and persistence.

C. Candidate's Self-Assessment

• In addition to two to four specific areas of development during the F99 phase, include two to four specific areas of development during the K00 phase to attain the stated research training and career goals.

D. Scientific Perspective

• Address the scientific perspective of both phases of the F99/K00. Go beyond the information addressed in the Scientific Foundation and Rationale section of the Research Training Plan to demonstrate the significance of your specific research interests and goals in addressing key gaps in the broader scientific field.

Research Training Project Specific Aims and Strategy

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

Training Activities and Timeline

The plan and timeline must cover both the F99 and K00 phases of the award. The research training plan activities should not just be a list of activities; provide justification for planned activities based on your goals, strengths, and weaknesses identified in the candidate's self-assessment.

• Provide a timeline that spans both phases detailing the proposed research training, professional development, and other activities. For the F99 phase, describe planned activities in detail, by year. For the K00 phase, provide a broad overview of the desired scientific and professional activities. For both phases, identify the technical, conceptual, and analytical skills to be learned or enhanced during the award and how these will complement existing strengths and fill gaps, as described in the self-assessment.
• For each phase, provide specific examples of how the proposed research training will facilitate the transition to the next career stage. If the K00 research direction is markedly different from the F99 research area, describe efforts and/or plans during the F99 phase training that provide preparation for the K00 research.
• For the F99 phase, describe why the sponsor(s), collaborators, and research training environment are appropriate for the proposed research training plan and sufficient to address all the candidate's development goals.
• For the K00 phase, a specific mentor does not need to be identified, but a plan for identifying and vetting a mentor(s) should be included, and an appropriate set of qualifications and mentor attributes should be described (research expertise, mentoring philosophy, etc.), as well as features of the postdoctoral scientific environment (resources, scientific specialization, size, etc).
• When describing the collaborative process between the candidate and the sponsor(s) in preparing the research training plan, describe how the research training plan builds on current projects in the lab, while allowing the candidate to develop new skills and conduct research with increasing independence and intellectual contribution. 

Research Training Project - Specific Aims

All candidates must use these two Specific Aims:

Specific Aim 1: The Dissertation Research Project.

Provide a detailed description of the overall dissertation research project, what has been accomplished to date (preliminary data may be included), and the research to be completed in the F99 phase.

Specific Aim 2: The Postdoctoral Research Direction.

Identify the research direction to be pursued for the K00 phase.

Research Training Project - Strategy

Candidates should individually address the Scientific Foundation and Rationale and Approach for each Specific Aim and address the Scored Review Criteria indicated in Section V.1.

Specific Aim 1:

Scientific Foundation and Rationale

• Provide a thoughtful overview of the dissertation research, including the scientific question being addressed and its potential impact on the dissertation research field.
• The Research Strategy should offer a clearly stated rationale and hypothesis, go beyond just experimental details, and provide perspective about the expected outcomes and significance.
• Describe the strengths and weaknesses in the rigor of the prior research (both published and unpublished) that serves as the key support for the proposed project.
• Explain how the proposed project will improve scientific knowledge, technical capability, and/or clinical practice in one or more broad fields.

Approach

The approach for this aim should be organized into two sections:

1. A progress report on the dissertation research project thus far, including the approaches used, research outcomes obtained, and important methodologies learned and how they contribute to the long-term career goal;
2. A detailed research proposal for the work to be completed in the F99 phase, including experimental design, anticipated results, potential problems, alternative strategies, and potential follow-up studies, following the instructions in the How to Apply-Application Guide. Highlight new technical and professional skills to be learned and their contribution to the long-term career goal. Candidates must outline research and career development milestones for the transition from the F99 phase of the award to the K00 award phase. If the candidate is to gain experience in a clinical trial as part of their research training, describe the relationship of the proposed research project to the clinical trial.

Specific Aim 2:

Scientific Foundation and Rationale

• Describe a specific scientific question or observation that will be investigated. Explain how this question or observation is related to the candidate's research interests and how this work will help advance this research direction. Explain the significance of and rationale for the K00 research direction.
• The postdoctoral research plan does not have to be a continuation or within scope of the predoctoral research, but it should describe a logical trajectory from the predoctoral research to a productive career in the biomedical workforce. Explain how this question or observation is related to the candidate's research interests and how this work will help advance this research direction.
• Describe the strengths and weaknesses in the rigor of the prior research (both published and unpublished) that serves as the key support for the proposed project.
• Explain how the proposed project will improve scientific knowledge, technical capability, and/or clinical practice in one or more broad fields.

Approach

Provide a general description of how the research will be conducted, including approaches and methodologies to be used, anticipated results, challenges that might arise and how to address them. Career and professional development skills to be acquired should also be detailed. 

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.

A. Mentoring Approach and Candidate Mentoring Plan

• The mentor must confirm that 1) the candidate is in a PhD program (include month and year of entry into the PhD program) 2) has reached the dissertation phase (include month and year of transition to dissertation phase) and 3) that the candidate has 1-2 years from the requested award start date before completion of their PhD (include month and year of anticipated graduation).
• The mentoring plan for the F99 phase should be individualized for the candidate and aligned with the Research Training Plan and the goals and activities identified in the Candidate section. It should not just be a list of activities; it should describe the candidate's strengths and gaps in needed skills, why these specific activities are appropriate for the candidate, and outline how the training plan will capitalize on the candidate's strengths and fill any gaps to help them achieve their stated career goals.
• Describe how the combined expertise of the sponsor, co-sponsor(s), collaborators, contributors, consultants, and/or advisory committee will ensure that all areas of the candidate's development and mentoring needs are adequately covered.
• Describe how the sponsor and co-sponsor(s) (as well as any collaborators, contributors, and/or consultants providing mentoring) will communicate and coordinate their efforts to mentor the applicant effectively.
• The plan should describe how the sponsor will facilitate the candidate's transition to the next stage of their career, including the search for the K00 mentor, and how the candidate's research and career development progress will be monitored and evaluated throughout the F99 phase, with specific milestones listed.
• While candidates are not necessarily expected to already have a first-authored publication from their graduate work, the Candidate Mentoring Plan should describe a plan and timeline for the candidate to achieve meaningful publishable results that will allow them to successfully transition into the K00 phase. Sponsors are encouraged to include the standards and expectations for authorship of publications in the sponsor(s) lab. 

C. Commitment to the Candidate's Research Training Plan

Include a description of how the sponsor(s) promote(s) the development of candidate skills in approaches to rigorous experimental design, methods of data collection, data analysis, interpretation, and reporting as well as ethically sound and responsible scientific research.

D. Research Training Environment

When describing opportunities for professional development and intellectual interactions, do not just list available opportunities, but indicate which opportunities the candidate will participate in during the research training period and how they will further the candidate's scientific development. 

E. Candidate's Potential

In this section, the sponsor should address both the candidate's potential for successful completion of the F99 and K00 phases and for becoming an independent investigator. 

Clinical Trial Training (If proposed)

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.

Letters of Support from Collaborators, Contributors, and Consultants

• Letter(s) of support should confirm the writer's participation (including frequency of meetings), document the expertise they will contribute, and describe their specific role.
• Advisory committee members (if applicable): An advisory committee is optional. The advisory committee for this application may be the same as the Dissertation Committee, but that is not required. If included, signed statements must be provided by each member of the proposed advisory committee. Unless also listed as senior/key personnel, these individuals do not need to provide their biographical sketches.

Other Plan(s)

A Data Management and Sharing Plan is not applicable for this NOFO.

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.

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.

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

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.

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.

An NIH 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. 

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 grantdisclosures@oig.hhs.gov. 

Applicant organizations 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 funding opportunity, reviewers should note the following: F99/K00 candidates are not required to have a first-author graduate publication. Instead, they should show that their proposed research and career development plan will support a successful transition to postdoctoral training. Consider the K00 research direction and career development activities with the understanding that the F99/K00 candidates often have not yet identified their postdoctoral setting. Thus, the K00 research direction should outline a broad scientific area of interest, rather than as a detailed experimental plan.

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.

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. 

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

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 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.

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 (IRB) or Independent Ethics Committee (IEC) Approval: Recipient institutions must ensure that protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the 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.

By applying for or accepting federal funds from HHS, recipients certify compliance with all federal antidiscrimination laws and these requirements and that complying with those laws is a material condition of receiving federal funding streams. Recipients are responsible for ensuring subrecipients, contractors, and partners also comply.

Applicants and recipients are strongly encouraged to refer to the NIH Director's Statement of Priorities, entitled "Advancing NIH's Mission Through a Unified Strategy."

Recipients are responsible for ensuring that their activities comply with all applicable federal regulations. Pursuant to 2 CFR 200.340, by accepting an NIH award, the recipient agrees that continued funding for the award is contingent upon the availability of appropriated funds, recipient satisfactory performance, compliance with the Terms and Conditions of the award, and may also otherwise be terminated, to the extent authorized by law, if the agency determines that the award no longer effectuates the program goals or agency priorities, in line with 2 CFR 200.340(a)(4).

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.

Cybersecurity plans and procedures must at minimum include the following:

• Develop cybersecurity plans and procedures, modeled after the NIST Cybersecurity framework, to protect HHS systems and data:
  • Identify:
    • Develop an inventory of all assets and accounts with access to HHS owned and operated information or operational technology systems or which obtain PII or PHI for the purposes of the award.
  • Protect:
    • Limit access to HHS owned and operated systems to only those in need of access to complete reward activities.
    • Require all staff to complete annual cybersecurity and privacy awareness training. Visit 405(d): Knowledge on Demand (hhs.gov) to obtain free trainings, if needed.
    • Enable multifactor authentication for all employees, subrecipients, and third-party entities to access HHS owned and operated information or operational technology systems.
    • Regularly backup sensitive data and test backups.
  • Detect:
    • Install anti-virus or anti-malware software on all devices, servers, and accounts used to connect to HHS owned and operated systems.
  • Respond:
    • Develop an incident response plan. See Incident-Response-Plan-Basics_508c.pdf (cisa.gov) to learn about developing incident response plans.
    • Have cybersecurity incident reporting procedures that ensure the relevant HHS awarding agencies are notified of a cybersecurity incident within 48 hours of discovery. A cybersecurity incident is defined as an unplanned interruption to a technology service or reduction in the quality of a technology service, or an occurrence that actually or potentially jeopardizes the confidentiality, integrity, or availability of an information system or the information the system processes, stores, or transmits.
  • Recover:
    • Investigate incidents and plug any security gaps identified. 

All activities proposed in your application and budget narrative must align with applicable law, including but not limited to statutes, executive orders, federal regulations and applicable judicial holdings.  Accordingly, discretionary awards shall not be used to fund, promote, encourage, subsidize, or facilitate; racial preferences or other forms of racial discrimination by the recipient, including activities where race or intentional proxies for race will be used as a selection criterion for employment or program participation; denial by the recipient of the sex binary in humans, or the belief that sex is a chosen or mutable characteristic; illegal immigration; or any other initiatives that compromise public safety.  If an application does not align, the application will not receive funding to the extent permitted by law and applicable court orders.

For applications involving substance abuse, the application must not support harm reduction. Please see Updated Funding Guidance for Recipients on Supplies and Services.

For applications involving funding Medication-Assisted Treatment (MAT) or medications for opioid use disorder (MOUD), this funding should be used to provide comprehensive treatment and recovery support services rather than medication-only models for opioid use disorder. Services should include medications, where clinically indicated, in conjunction with psychosocial and other treatment and recovery support services. Funding can also be used to support individualized tapering and discontinuation of medications when clinically indicated. Please see Updated Funding Guidance for Recipients on  MAT/MOUD.

As of October 1, 2025, HHS has adopted 2 CFR Part 200, with some modifications included in 2 CFR Part 300. These regulations replace those in 45 CFR Part 75. However, for NIH, under the Consolidated Appropriations Act for FY 2026, (P.L. 119-75, Division B, Title II, Sec. 224), the provisions relating to indirect costs in 45 CFR 75 continue to apply to NIH awards. Consistent with the statute, NIH will not apply updated thresholds outlined within 2 CFR Part 200, at this time.

Transition to the Postdoctoral Career Development K00 Phase

Transition from the predoctoral (F99) phase to the postdoctoral (K00) phase is not automatic. To activate the K00 phase of the grant, individuals must have successfully completed the Ph.D. degree and accepted a full-time postdoctoral position to carry out biomedical research within the mission of the awarding Institute or Center (IC). Individuals must also submit a K00 Transition Application (see below) for approval. 

To enhance the breadth of their scientific training and career development, candidates are expected to apply for postdoctoral positions at institutions different from where they conducted their doctoral research. Candidates must choose K00 mentor(s) different from their F99 sponsor(s). It is important for all candidates, but especially so for candidates who intend to stay at the predoctoral phase institution for the postdoctoral phase, to provide a plan by which they will separate scientifically from their Ph.D. sponsor. 

K00 Institution

An eligible K00 institution must have appropriate infrastructure and research funding to support the proposed research program. Foreign institutions are not eligible. 

Candidates may apply for postdoctoral positions within the NIH intramural research program (IRP). However, should the individual accept such a position in the IRP, the postdoctoral phase of the award will not be activated. This is because NIH intramural scientists are supported directly by NIH intramural funds and are not eligible for NIH extramural grant awards. F99 fellows who accept a postdoctoral position in the IRP will be required to submit a final progress report and a final evaluation statement by the primary F99 mentor instead of a K00 application. 

Eligibility of for-profit organizations for the K00 phase depends on the nature of the appointment, and the ability of the postdoctoral fellow to conduct mentored postdoctoral research and freely disseminate findings, including through peer-reviewed publications and data sharing. Candidates are strongly encouraged to discuss job offers at for-profit organizations with NIH program staff well in advance of accepting such an offer.

Submission

Prospective candidates are strongly encouraged to contact their NIH program official as soon as a plan to assume a postdoctoral position develops, no later than 6 months prior to the proposed start date of the K00 award.  At that time, individuals should discuss plans for transition to, and application for, the K00 phase with their NIH program official.

The K00 phase postdoctoral institution must submit materials for the K00 phase no later than 4 months prior to the proposed activation date of the K00 award, but confirm submission timing with the awarding NIH IC program official. The institution's Authorized Organizational Representative will email the application in a single PDF format to the NIH Scientific Contact of the awarding NIH Institute or Center listed in the Notice of Award. 

Review and Notification

The K00 application will be evaluated by NIH staff for completeness and responsiveness to the program. Candidates who are approved to transition will receive a Notice of Award reflecting the new K00 activity code, the dollar amount, and the new grantee organization (if applicable). Candidates who are not approved to transition will receive written notification from the NIH awarding component communicating the rationale for the disapproval and should work with extramural program staff on resubmissions. This notification typically will be sent within 60 days of receipt of the K00 application.

Instructions for the K00 Transition Application

Candidates must follow the Career Development (K) Instructions in the How to Apply - Application Guide, except where instructed in this funding opportunity to do otherwise, as described below.

The K00 Transition Application will include the following components:

1. A new SF424 (R & R) cover page signed by the K00 phase institutional representative.
2. An updated PHS 398 Cover Page Supplement Form
3. Updated R&R Other Project Information Form, including K00 Project Summary/Abstract, Project Narrative, Bibliography & References Cited, Facilities & Other Resources, and Equipment sections;
   • Other Attachments section, attach the following:
     • A final progress report for the F99 phase;
     • A final evaluation statement by the F99 primary sponsor;
4. Updated Project/Performance Site Primary Location(s) Form
5. Updated R&R Senior/Key Person Profile (Expanded), including Biographical sketches for candidate and K00 mentor(s).
   • The mentor(s) personal statement(s) should include a description of their past and current mentoring and training philosophy;
6. R&R Budget Form, K00 budgets consist of salary and fringe benefits, other program related expenses, and indirect costs, as described in Part II, Section II of this funding opportunity announcement. Other costs are not allowed;
7. PHS 398 Career Development Award Supplemental Form, which should include: 

Candidate Section: 

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

• Describe the candidate's current and long-term research and career objectives.
• Present a scientific history that shows a logical progression from the candidate's prior research and training experiences (including the F99 phase) to the training and research experiences proposed for the K00 phase of the award, which will ultimately lead them to develop into a productive, independent researcher.
• Describe how the candidate plans to separate scientifically from their F99 and K00 sponsors.
• Provide a timeline with milestones for the research and career development experiences proposed.
• Describe how the research training in the K00 phase of the award, combined with all previous research training and experiences, will provide the tools, skills and knowledge necessary to develop into a productive, independent researcher.

Research Plan Section:

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

• An updated Specific Aims and Research Strategy should be described in less than 5 pages. These should reflect current plans for the K00 phase and may differ from what was originally proposed as the Postdoctoral Research Direction in the F99/K00 application.
• NIH application instructions related to rigor and reproducibility must be followed (see Guidance: Rigor and Reproducibility in Grant Applications). 
• Updated Training in the Responsible Conduct of Research

Mentor, Co-Mentor, Consultant, Collaborators Section:

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

• Include a detailed, specific, and tailored plan for fostering the candidate's research career independence and transitioning the candidate to the next stage of their career by the end of the project award period.
  • While previous experience is not a pre-requisite to serve as a sponsor, as appropriate, candidates should include co-sponsor(s), contributor(s), collaborator(s), consultant(s), and/or an advisory committee to ensure all areas of development and mentoring needs are covered.
  • Clearly describe the role of each mentor, co-mentor, collaborator, and consultant (as applicable) in the K00 and their commitment to the candidate. Describe how the combined expertise of the mentor, co-mentor(s), collaborators, contributors, consultants, and/or advisory committee will ensure that all areas of the candidate's development and mentoring needs are adequately covered.
  • Describe how the proposed research further expands upon and/or is distinct from ongoing projects in the mentor's lab. Include a plan for transitioning the candidate to independence and a description of how the mentor will help the candidate achieve scientific independence from their mentor, including a statement identifying the components of the proposed research that the candidate will utilize when they transition to an independent career.
• The mentor should discuss the availability of adequate resources and research support available for the K00 project.
• If the candidate is proposing to gain experience in a clinical trial as part of their research career development, the mentor or co-mentor 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.
• New Letters of Support from Collaborators, Contributors and Consultants
• An advisory committee is recommended but not required. If applicable: signed statements must be provided by each member of the proposed advisory committee. These statements should confirm their participation, describe their specific roles, and document the expertise they will contribute.

Environment and Institutional Commitment to Candidate Section:

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

• Description of Institutional Environment
• Institutional Commitment to Candidate's Research Career Development:
  • Provide a statement of commitment to the candidate and their career goals, i.e., conducting the proposed mentored research and career development activities during the K00 phase.
  • Provide assurance that the candidate will be able to devote a minimum of 9 person-months (75% of full-time professional effort) to the development of their research program. The remaining effort should be devoted to activities related to the development of the candidate's career in the biomedical research workforce.
  • Provide assurance that the research facilities, resources, and training opportunities will be available for the candidate's planned career development and research programs during the K00 award period.
  • Provide assurance that appropriate time and support for any proposed mentor(s) and/or other staff consistent with the career development plan will be available during the K00 award period.
  • The institutional commitment must be dated and signed by the person who is authorized to commit the institution to the agreements and assurances listed above. In most cases, this will be the dean or the chair of the department.

Other Research Plan Sections:

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

• Vertebrate Animals (as appropriate);
• Select Agent Research (as appropriate);
• Resource Sharing (as appropriate);
• Consortium/Contractual Arrangements (as appropriate);
• Other Plan(s) - Data management and Sharing (DMS) Plans are required for K00 and must be included within "Other Plan(s)". A Data Management and Sharing Plan (DMS Plan) is required for any NIH-funded or conducted research that will generate scientific data. Applicants must submit the DMS Plan at the time of application using the NIH DMS Plan Format Page. The DMS Plan must address the elements in the structured format should not exceed two (2) pages. Where the DMS Plan Format Page requires a "Yes or No" response, no additional narrative is allowed. 
• Authentication of Key Biological and/or Chemical Resources (as appropriate).

8. Updated PHS Human Subjects and Clinical Trials Information Form 

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

F99 Phase: 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.

K00 Phase: Awardees must complete the "Inventions and Patents" section when submitting the Research Performance Progress Report (RPPR).

3. Data Management and Sharing

F99 Phase: Data Management and Sharing is not applicable to the F99 phase.

K00 Phase: A Data Management and Sharing Plan (DMS Plan) is required for any NIH-funded or conducted research that will generate scientific data. Candidates must submit the DMS Plan at the time of application using the NIH DMS Plan Format Page. The DMS Plan must address the elements in the structured format. Where the DMS Plan Format Page requires a "Yes or No" response, no additional narrative is allowed.

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 Reporting Requirements:

• Individuals admitted to the United States as Permanent Residents must submit notarized evidence of legal admission prior to the award.
• The applicant organization must notify the NIH within 30 days if the end date of the fellowship occurs prior to the scheduled end date of the F99 award phase.
• For the K00 phase, 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.

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.

Within ten years of making awards under this program, NIH will assess the program's overall outcomes and consider whether there is a continuing need for the program. Upon the completion of this evaluation, NIH will determine whether to (a) continue the program as currently configured, (b) continue the program with modifications, or (c) discontinue the program. 

The overall evaluation of the program will be based on metrics that will include, but are not limited to, the following:

For programs involving graduate students:

• Successful completion of a STEM graduate program
• Subsequent participation in a formal research training or career development program in a STEM field
• Subsequent participation in research or employment in a STEM field
• Authorship of scientific publications in a STEM field
• Subsequent independent research grant support from NIH or another source

For programs involving postdoctorates and early career investigators:

• Subsequent participation in a formal research training or career development program in a STEM field
• Subsequent participation in research or employment in a STEM field
• Authorship of scientific publications in a STEM field
• Subsequent independent research grant support from NIH or another source

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, Center, and Office (ICO) program requirements for this NOFO, prospective candidates MUST consult the NIH Research Training and Career Development website, to make sure that their application is responsive to the requirements of one of the participating NIH ICOs. Prior consultation with NIH staff is strongly encouraged.

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.

Grants.gov Support Center - Questions regarding Grants.gov registration and services (e.g., Workspace, subscriptions).

Institutes, Centers, and Offices:

National Institute on Aging (NIA)
Email: NIA-NOFO-Scientific@nih.gov

Office of Research Training and Career Development 
National Institutes of Drug Abuse (NIDA)  
Email: NIDA_Training@nida.nih.gov

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Email: NICHDextrain@mail.nih.gov

The INvestigation of Co-occurring conditions across the Lifespan to Understand Down syndromE (INCLUDE) Project
Email: DownSyndromeINCLUDE@mail.nih.gov

National Institute of General Medical Sciences (NIGMS)
Email: NIGMSF99@nih.gov

NINDS Training Office                                                                                                                                                                                       
Email: NINDSFellowships@ninds.nih.gov

Center for Cancer Training
National Cancer Institute (NCI)
Email: NCIF99-K00@mail.nih.gov

NEI Extramural Programs 
Email: NEI_extramural@nih.gov

National Institute of Dental and Craniofacial Research (NIDCR)
Email: NIDCRtraining@nidcr.nih.gov

Tribal Health Research Office
Email: throinfo@od.nih.gov

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Email: niamstraining@mail.nih.gov 

Office of AIDS Research
Division of Program Coordination, Planning, and Strategic Initiatives
Office of the Director
Email: OARinfo@nih.gov
Phone: 1-301-496-0357

National Center for Complementary and Integrative Health (NCCIH)
Division of Extramural Research (DER)
Email: NCCIHDERFunding@nih.gov

National Human Genome Research Institute (NHGRI)
Email: NHGRI_Training@mail.nih.gov

Office of Research Training and Career Development
National Institute of Mental Health
Email: NIMHTraining@mail.nih.gov   

National Institute on Deafness and Other Communication Disorders (NIDCD)
Email: nidcd.training@mail.nih.gov

National Institute of Allergy and Infectious Diseases (NIAID)
Email: AITrainingHelpDesk@niaid.nih.gov

National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Email: NIAAA-Training@mail.nih.gov

National Institute of Environmental Health Sciences (NIEHS)
Email: NOFO.Information@niehs.nih.gov

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

See NIH Research Training and Career Development

National Institute on Aging (NIA)
Email: NIA-NOFO-Grants@nih.gov

Chief, Grants Management Officer 
National Institute of Drug Abuse (NIDA) 
Email: nidagmbemail@nida.nih.gov

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Email: nichdgrantsmanagement@mail.nih.gov

The INvestigation of Co-occurring conditions across the Lifespan to Understand Down syndromE (INCLUDE) Project
Email: DownSyndromeINCLUDE@mail.nih.gov

National Institute of General Medical Sciences (NIGMS)
Email: NIGMSTWDGABNOFO@nih.gov

NINDS Chief Grants Management Officer
Email: ChiefGrantsManagementOfficer@ninds.nih.gov

Office of Grants Administration
National Cancer Institute (NCI)
Email: NCIFinancialContact@nih.gov

NEI Grants Management 
Email: NEI_extramural@nih.gov

National Institute of Dental and Craniofacial Research (NIDCR)
Email: deeranotifications@nidcr.nih.gov

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Email: NIAMSGrants@nih.gov 

Office of AIDS Research
Division of Program Coordination, Planning, and Strategic Initiatives
Office of the Director
Email: OARinfo@nih.gov
Phone: 1-301-496-0357

National Center for Complementary and Integrative Health (NCCIH)
Office of Grants Management (OGM)
Email: NCCIHDERFunding@nih.gov

Grants Administration Branch
National Human Genome Research Institute (NHGRI)
Email: nhgrigab@mail.nih.gov

Grants Management (NOFOs)
National Institute of Mental Health (NIMH)
Email: NIMHNOFOGrantsManagement@mail.nih.gov  

National Institute on Deafness and Other Communication Disorders (NIDCD)
Email: NIDCDGrantsMgt@nidcd.nih.gov

National Institute of Allergy and Infectious Diseases (NIAID)
Email: NIAIDFinancial-GrantsContact@mail.nih.gov

National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Grants Management Contact
Email: NIAAA-GMB@mail.nih.gov

National Institute of Environmental Health Sciences (NIEHS)
Email: NOFO.Information@niehs.nih.gov

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.

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 63A and 2 CFR Part 200.