Part 1. Overview Information

Key Dates

It is critical that applicants 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 Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

1. Use the NIH ASSIST system to prepare, submit and track your application online.
2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.
   
   
3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.



Table of Contents
Part 1. Overview Information
Key Dates
Part 2. Full Text of Announcement
Section I. 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

Note: 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.

The purpose of the NIDCR Predoctoral to Postdoctoral Transition Award to Promote a Diverse Dental, Oral and Craniofacial Research Workforce (F99/K00) is to provide a structured pathway for graduate students from diverse backgrounds, including those from groups underrepresented in the biomedical, clinical, and behavioral sciences on a national basis (see Notice of NIH's Interest in Diversity), to transition to postdoctoral research positions focused on DOC research.  NIDCR encourages multidisciplinary and interdisciplinary research training and career development to prepare a workforce that can address complex oral health problems in a highly diverse U.S. population and can contribute to the realization of NIDCR research priorities and the NIDCR Strategic Plan.  The NIDCR is committed to promoting a diverse and inclusive DOC research workforce and supporting opportunities for individuals from diverse backgrounds, including those from underrepresented groups, to bring their inquiry and  experiences to research, discovery, and the improvement of DOC health.   

Background

The NIDCR is committed to promoting a diverse and inclusive DOC research workforce and supporting opportunities for individuals from diverse backgrounds, including those from underrepresented groups, to bring their inquiry and experiences to research, discovery, and the improvement of DOC health. While scientific workforce diversity supports and is integral to the NIH mission, expanding the pool of scientists from nationally underrepresented backgrounds in the biomedical research workforce has remained an elusive goal (see Policy Supporting Next Generation Researchers Initiative). In 2024, the Advisory Committee to the NIH Director (ACD) endorsed a report prepared by the ACD Working Group on Re-envisioning NIH-Supported Postdoctoral Training aimed toward improving the biomedical workforce with a focus on identifying and understanding the critical factors and issues related to a decline in postdoctoral fellows and recommendations to address the identified factors. The report identified the important role of quality mentorship and professional development opportunities and the need for community building.   Recommendations provided by this Working Group are in alignment with the recommendations defined by the 2012 ACD Working Group on Diversity in the Biomedical Research Workforce which were to support the research career development of postdoctorates and junior faculty, including those from underrepresented groups, highlight culturally appropriate mentoring, mentorship networks, and the development of mentee grant writing skills facilitated by established, well respected scientists to enhance the mentees' ability to advance in their research career and successfully compete for research funding. Mentorship, including mentorship by senior and junior academic mentors, scientific mentors, and peers has been shown to be an effective intervention for supporting junior clinician-scientists, particularly among women and underrepresented minorities in their career development, career transition, academic achievements, and retention in academic research (Byington et al., 2016; Kuhn and Castaño 2016; Mayer et al., 2014;Harawa et al., 2017). Mentorship can have an overall positive effect on mentees, mentors and the overall research environment (e.g., improved academic achievement, retention, and degree attainment, career satisfaction, career commitment, and integration of trainees from underrepresented groups into the biomedical academic community; see National Academies of Sciences, Engineering, and Medicine 2019 The Science of Effective Mentorship in STEMM).  Formal training, and ongoing professional development in effective mentoring practices has been shown to improve the knowledge and skills of research mentors across career stages.

This NIDCR F99/K00 award is intended to provide individualized mentorship over the transition from predoctoral student to postdoctoral researcher through two contiguous support phases.  The first phase of the award (F99) will provide support at a minimum of 1 year and no more than 2 years of research training for individuals in PhD or dual degree clinician scientist programs.  During the F99 phase, students are expected to complete all PhD and/or dual degree training, identify postdoctoral research mentor(s) distinct from their primary dissertation advisor(s), and work with a mentoring team to develop a postdoctoral research project in a field directly related to the NIDCR Mission and NIDCR grant programs.  The second phase of the award (K00) will provide support for up to 3 years of mentored postdoctoral research and career development.  F99/K00 applicants are not required to identify postdoctoral research mentors at the time of application. At the time of transition, individuals receiving support under an F99 award are encouraged, though not required, to transition to postdoctoral positions in institutions or departments different from where they conducted their graduate research to expand their scientific network and research experiences.  K00 awards will be made only to support fellows who have successfully completed doctoral degree requirements, completed their F99 research training programs, secured a postdoctoral position, and have submitted strong research training and career development plans that will facilitate independent research careers dedicated to improving oral health.

This NIDCR F99/K00 award program is intended to encourage participation of individuals from diverse backgrounds in the DOC biomedical and behavioral research workforce, including individuals from underrepresented groups, who can bring their unique experiences to contribute to innovative ideas and improve DOC health.  Desired program outcomes include completion of a doctoral degree program and transition to postdoctoral positions in DOC research. K00 PIs are encouraged to work with their mentors and institutions to apply for subsequent individual career development awards, e.g., K01, K08, K23 and Pathway to Independence awards (K99/R00) as per program eligibility requirements.

Note: 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.

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

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

Section II. Award Information

Other Award Budget Information

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

Higher Education Institutions

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Governments

• None

• None

F99 Eligibility: All domestic PhD-granting institution/organization types listed above are eligible to submit an application. Multiple applications from an institution are allowed.

K00 Eligibility: All domestic institution/organization types listed above are eligible to submit K00 transition phase applications on behalf of individuals receiving support from F99 awards.  Note that if the individual receiving support from the F99 award accepts a postdoctoral position in the NIH intramural research program or another federal agency, the postdoctoral phase (K00) will not be awarded, as federal employees are not eligible to receive support from NIH extramural grants. The postdoctoral phase will then be supported directly by the federal agency offering the postdoctoral position.  

Before working with their institution to submit an F99/K00 application, the candidate must identify a F99 phase sponsoring institution.  The F99 phase 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 in the field(s) proposed by the candidate. All institutions with the appropriate resources and commitment are encouraged to apply.

Foreign Organizations

Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications for additional information. 

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

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

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

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 individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with their organization to develop an application for support. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019. 

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

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).

The candidate must be currently enrolled in a PhD or equivalent research degree program (e.g., EngD, DNSc, DrPH, DSW, PharmD, ScD), a formally combined DDS/DMD-PhD program, or other combined professional/clinical and research doctoral program (e.g., MD-PhD) in the biomedical, behavioral, or clinical sciences at a domestic institution. At the time of award, the candidate is expected to require at least one year, but no more than 2 years to complete their PhD or dual-degree training (F99 phase) before transitioning to mentored postdoctoral research training (K00 phase).  Only DDS/DMD-PhD dual degree candidates are allowed to receive financial support for clinical training as long as research training is also incorporated.  Other dual degree candidates (e.g., MD-PhD) can receive support only for the research portion of their dual degree program.

Candidates conducting dissertation research in DOC or related research fields are encouraged to apply.  Candidates conducting F99 research in fields outside of DOC research are also eligible to apply; however, the K00 phase of the application must propose research that directly aligns with the NIDCR mission.  Potential candidates are strongly encouraged to discuss their eligibility with the NIDCR Scientific Program contact in advance of application.

If a candidate completes all doctoral dissertation requirements or begins a postdoctoral position before an F99 award is issued, neither the F99 nor K00 will be awarded.

Individuals who are currently being supported by F30 or F31 awards are eligible to work with their institutions to apply for this program; however, they must relinquish support under the F30 or F31 award if and when they decide to accept support under the F99 award. Individuals who receive F99/K00 support remain eligible and are encouraged to apply for subsequent individual research career development awards (e.g., K01, K08, K23) and pathway to independence awards (K99/R00) provided they meet program eligibility requirements.

Note: the NIH Loan Repayment Programs (LRPs) are intended to attract and retain promising postdoctoral and early-stage investigators in research careers by helping them to repay their educational debt. Recipients of postdoctoral fellowships, those receiving support under K00 and NIH research career development awards are encouraged to apply for an extramural LRP award.

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).

Each candidate may work with their institutions to submit one fellowship application at a time.  An individual may not have two or more competing NIH individual fellowship applications pending review concurrently.  A candidate for an F99/K00 award may not simultaneously submit or have an application pending for any other PHS fellowship award (e.g., F31 or any other PHS award that duplicates any of the provisions of the F99/K00 award).

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. 

At the time of award, F99 awardees 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 institution in accordance with its own policies.

Individuals receiving support under K00 awardees are required to have a full-time appointment at the K00 phase institution, and to commit a minimum of 9 person months (or 75% of their full-time professional effort) to their research career development. Individuals receiving support under 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 K00 award, as long as such duties do not interfere with or detract from the proposed research career development program.

Before submitting the application, the candidate must identify an F99 sponsor(s) who will supervise the proposed mentored training experience. Candidates conducting F99 research in fields outside of DOC research or planning to switch to a new DOC research area in the K00 phase are expected to include an F99 co-sponsor or consultant with relevant DOC research expertise and a strong mentorship record. A dentist scientist co-sponsor or consultant, in an area of clinical interest to the candidate is encouraged. Candidates are encouraged to identify more than one sponsor, i.e., a sponsor team of sponsors, 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 F99 training. The primary F99 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 F99 sponsor must document the availability of sufficient research funds and facilities for the proposed research training. The primary F99 sponsor can be an independent investigator at any career stage, including an early-stage investigator. Regardless of career stage, the primary F99 sponsor must demonstrate a commitment to ensuring the candidate receives tailored research training that will facilitate their skills development and career advancement. The candidate must work with the sponsor(s) in preparing the F99/K00 application. 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 applicants 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 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 SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

Other Project Information

All instructions in the SF424 (R&R) Application Guide must be followed.

The filename provided for each “Other Attachment” will be the name used for the bookmark in the electronic application in eRA Commons.

All instructions in the SF424 (R&R) 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 applicant) 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

Biographical Sketch:

Candidate: In the "Personal Statement "section, candidates should follow the instructions for "Candidates for dissertation research awards."  In addition, the candidate should address how completion of postdoctoral training will help the candidate achieve their career goals. In this section, candidates should:

• Describe experiences that contributed to their professional development and form the foundation for the training proposed.
• Include activities that demonstrate their passion and commitment to a scientific career.
• Provide an example of a challenge that they faced in research and have overcome using creativity, persistence, or other approach.

Candidates should not complete Section D “Scholastic Performance.”

Sponsor and Co-Sponsor(s): In the "Personal Statement" section, the sponsor and any co-sponsors must include a statement describing their mentoring and training philosophy, including their commitment to the candidate and an inclusive environment.    Do not duplicate information described elsewhere in the application.  Highlight how the trainee’s research plan differs from the sponsor’s research.

The PHS Fellowship Supplemental Form is comprised of the following sections:

• Fellowship Applicant
• Research Training Plan
• Sponsor(s), Collaborator(s), and Consultant(s);
• Institutional Environment & Commitment to Training
• Other Research Training Plan Sections
• Additional Information
• Budget
• Appendix

All instructions in the SF424 (R&R) Application Guide must be followed.

Fellowship Applicant Section

Candidate’s Background and Goals for Fellowship Training

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

Follow instructions for “Advanced graduate students.”

Doctoral Dissertation and Research Experience

Include a description of how the combination of past research and/or clinical experiences, and the proposed F99/K00 plans will contribute to achieving the long-term career goal of becoming an independent DOC research investigator.  Note: clinical training will only be supported for DDS/DMD-PhD candidates.  Other dual degree students (e.g., MD-PhD) can only obtain funding for the PhD component of their training.

Training Goals and Objectives

Describe short-term and long-term DOC research career goals and explain how the F99/K00 will enable the attainment of these goals.  Also include intentions of applying for subsequent awards to support research beyond the K00 phase.

For each phase, identify the skills, theories, conceptual approaches, etc., to be learned or enhanced during the award, including, as applicable, expertise in rigorous research design, experimental methods, quantitative approaches, and data analysis and interpretation.  If the K00 research direction is scientifically different from the F99 research area, discuss how activities during the F99 phase, such as interactions with co-mentors and consultants, will provide the candidate with sufficient background to identify and conduct the proposed K00 postdoctoral research.

Activities Planned Under This Award

Describe the scientific and professional development activities planned for each phase and explain how the activities will facilitate the transition to each subsequent career stage and ultimately, establishment of an independent DOC research career. Include a timeline of activities with scientific, professional development, and career milestones and goals. A broad overview of anticipated K00 phase scientific and professional activities is appropriate since the sponsoring institution and mentor for the K00 phase are not known at the time of application.

Provide a strategy for identifying a K00 mentor in the DOC research area of focus and K00 institution.  Describe the desirable mentor qualifications and attributes as well as the institutional environment needed to facilitate the anticipated K00 phase research.  

DDS/DMD-PhD Dual Degree Students: The candidate’s research and clinical training activities planned under this award, should be individually tailored and well-integrated with the proposed research project. Describe the skills and techniques that the candidate intends to learn, as well as any planned, non-research activities (e.g., those relating to professional development and clinical activities) during the F99 award period. The candidate should provide a timeline and describe the phasing and duration of their dual degree program, clearly identifying the clinical and research components, describe progress to date, and identify the activities proposed during the F99 phase of the F99/K00 award.  On the timeline, indicate the percentage of time that will be devoted to clinical- and to research-related activities during each year of F99 support.

Research Training Plan

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

Specific Aims:

All candidates must use these two Specific Aims:

• Specific Aim 1: The F99 Research Project (typically the candidate’s dissertation research project): Provide a concise description of the F99 research project, what has been accomplished to date (preliminary data may be included), and the research and clinical training, if applicable, to be completed during the two-year F99 phase.
• Specific Aim 2: The Postdoctoral Research Direction: Identify a DOC research direction the candidate will pursue during the K00 phase.

Research Strategy

Specific Aim 1 (F99)

Significance

• Provide an overview of the PhD dissertation research being addressed.
• Explain the importance of the problem or critical barrier to progress that the proposed project addresses.
• 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 potential pitfalls and alternative approaches providing confidence that the candidate is likely to have a viable direction for continuing the project.
• Explain how the proposed project will improve scientific knowledge, technical capability, and/or clinical practice in one or more broad fields.
• Describe how the proposed F99 research and clinical training if applicable, is related to the candidate's next steps for the K00 career development phase.

Approach

• Describe the dissertation research, including the background, goal, rationale, and hypotheses of the research project(s). The Approach for this Aim should be organized into two sections:
  • A progress report on the dissertation research project thus far, including the approaches used, research outcomes obtained, and important methodologies learned.
  • A detailed research plan for the work to be completed in the F99 phase, including experimental design, proposal of how they will achieve robust and unbiased results, anticipated results, potential problems, alternative strategies, and potential follow-up studies. Describe plans to address weaknesses in the rigor of the prior research that serves as the key support for the proposed project.  Explain how relevant biological variables, such as sex, are factored into research designs and analyses for studies in animal models and humans.

Specific Aim 2 (K00):

Significance

• Identify an anticipated postdoctoral research direction relevant to the NIDCR mission to be pursued during the mentored K00 career development phase. Explain the significance of the K00 research direction and how this work has the potential to advance or address unanswered questions in DOC research.

Approach

• Provide a description of the research project or direction for the K00 phase including, as appropriate, potential experimental approaches and methodologies, anticipated experimental outcomes, potential challenges and alternative strategies. Explain how prior training, especially if the K00 research describes a new research direction for the applicant, has established a foundation for a DOC focused research career. Identify the technical and career development skills that will be achieved during the K00 training. Describe the mentorship expertise and institutional environment that is necessary to support the proposed K00 research and career development activities.

If the candidate is proposing to gain experience in a clinical trial as part of his or her research training, describe the relationship of the proposed research project to the clinical trial.

Sponsor(s), Collaborator(s), and Consultant(s)

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

DO NOT follow the SF424 (R&R) Application Guide instructions for this section. Instead, follow the instructions below.

Who must complete the “Sponsor and Co-Sponsor Statement” attachment: The “Sponsor and Co-Sponsor Statement” attachment is required. The sponsor and each cosponsor must provide statements as described below.  

Format: Follow the page limits for Sponsor and Co-Sponsor Statements in the NIH Table of Page Limits. The Sponsor and Co-Sponsor Statements can be integrated or written separately, but must be appended together and uploaded as a single PDF file. See NIH's Format Attachments page. Use of hyperlinks and URLs is not allowed unless specified in the NOFO.  

Content: Complete these items as comprehensively as possible so that the reviewers can make a meaningful evaluation of the mentoring environment.

Create a heading at the top of the first page titled “Sponsor and Co-Sponsor Statements.” Organize each statement in the specified order and use the instructions below. Start each section with the appropriate section heading:
A. Research Support Available
B. Sponsor’s/co-Sponsor’s Previous Predoctoral Trainees and Mentoring Philosophy
C. Training Plan, Environment, Research Facilities
D. Number of Trainees to be Supervised During the Fellowship
E. Candidate's Readiness and Potential Benefit from the Research Training Plan
F. Clinical Trial (if applicable)  

Each F99 sponsor and co-sponsor statement must address all the following sections (A-F).

A. Research Support Available
In a table, list all current and pending research and research training support specifically available to the candidate for this training experience, including institutional support. Include funding source, complete identifying number, title of the research or training program, name of the PD/PI, start and end dates, and the amount of the award. If the sponsor’s research support will end prior to the end of the proposed training period, the sponsor should describe a contingency plan for how the fellow’s research will be supported.
The role of the sponsor/co-sponsor in the Research Training Plan should be described. If one or more co-sponsors are proposed, this plan should describe the role of each sponsor and how they will communicate and coordinate their efforts to mentor the candidate effectively.

B. Sponsor’s/Co-sponsor’s Previous Predoctoral Trainees and Mentoring Philosophy
For all predoctoral individuals sponsored in the last 5 years, provide information on their research achievements, their present employing organizations, and their present position titles or occupations. For early-career sponsors, this may also include predoctoral students that were mentored while the sponsor was a postdoc or in a non-faculty position.  Regardless of career stage, the sponsor/co-sponsor should describe how their mentoring philosophy and any relevant previous mentoring experience will contribute to the success of the candidate's development.
 

Describe how the sponsor uses evidence-informed training and mentoring practices that promote the development of trainees from all backgrounds, including those from groups underrepresented in the biomedical sciences (see Notice of NIH's Interest in Diversity). Simply citing past trainees’ accomplishments is not sufficient evidence of effective training and mentoring.

C. Training Plan, Environment, Research Facilities
The candidate’s Research Training Plan should be individualized for the candidate, keeping in mind the candidate’s strengths and any areas of development.  The information contained in this section should augment, but not duplicate, information provided in the “Description of Institutional Environment” and “Commitment to Training” sections. This section should address the following:
? How the Research Training Plan has been individualized and optimized for the fellowship candidate's career goals. Specifically, describe the skills and techniques that the candidate will learn. Include items such as classes, seminars, credentials, opportunities for interaction with other groups and scientists, and any professional skills development opportunities. Specifically relate these to the candidate’s K00 research direction and career goals;
? How the sponsor(s) will support the candidate’s timely transition to the K00 phase and how the candidate’s research and career development progress will be monitored and evaluated throughout the F99 phase (e.g., by use of an Individual Development Plan);
? How the sponsor(s) have sufficient time to commit to the individualized Research Training Plan given their other professional obligations;
? The sponsor(s) commitment to mentoring and promoting inclusive, safe, and supportive research training environments;
? How the sponsor(s) promote the use of highest standards of practice to ensure the safety of all individuals in the research environment;
? How the sponsor(s) conduct rigorous and unbiased experimental design, methodology, analysis, interpretation, and reporting of results as well as ethically sound and responsible scientific research. 
? How the sponsor(s) provide appropriate and adequate opportunities for trainees to present and publish research findings, and meet scientists within the community at national conferences and meetings;
? How the candidate will be able to complete the research component of the Research Training Plan given the research environment and available research facilities and equipment.

D. Number of Trainees to be Supervised During the Fellowship
Indicate how many trainees (e.g., postbaccalaureate, predoctoral, and postdoctoral) the Sponsor/Co-sponsor is anticipated to supervise during the award period.  

E. Clinical Trial (if applicable)
If the candidate is proposing to gain experience in a clinical trial as part of their 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 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 sponsor or individual leading the trial.

Include a statement/attestation that the sponsor will be responsible for the clinical trial. Describe how the sponsor will provide this oversight (be careful not to overstate the fellow’s responsibilities). Include details on the specific roles/responsibilities of the fellow and sponsor, keeping in mind that the terms of a fellowship award do not permit the fellow to lead a clinical trial.
 

Description of Institutional Environment and Commitment to Training

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

• Follow instructions for “F30 and F31 applications: Educational Information”
• Describe how the institutional environment supports the candidate’s F99 phase of their Research Training Plan. Describe any institutional career development resources and activities that will be available to contribute to the candidate’s career development (e.g., an office of graduate education, a career development seminar series or course, etc.). 
• Detail the institutional commitment to promoting the following:
  • A culture in which the highest standards of safety, scientific rigor, reproducibility, and responsible conduct of research are advanced; and
  • A culture that has a welcoming environment and does not tolerate discrimination, harassment/abusive behavior.
• Confirm that the candidate has 1-2 years from time of award before completion of their Ph.D. (provide the month and year of anticipated graduation).
• Include the name of the individual providing this information at the end of the description. This information is typically provided by the director of the graduate program or the department chair.

Description of Candidate’s Contribution to Program Goals: The sponsoring institution must provide a document on institutional letterhead that explains, in a manner consistent with applicable law, how the candidate’s participation will further the goals of the fellowship program.  Please note that the race, ethnicity, or sex of the candidate will not be considered in the application review process or when making funding decisions. 

The "Description of Candidate’s Contribution to Program Goals” attachment must be dated and signed by an institutional official. In most cases, this will be the dean or the chairman of the department. The signature must appear over the signer's name and title at the end of the statement.

See instructions in the SF424 (R&R) Application Guide.

Appendix

Limited items are allowed in the Appendix.  Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

Other Attachment – Inclusivity Statement

1. The application must include a statement from the candidate for the F99/K00 award describing their commitment to promoting diversity and inclusivity in the biomedical sciences research workforce, through means consistent with applicable law, including any past or present leadership, mentoring and outreach activities that encouraged prospective researchers from underrepresented groups to participate in the biomedical research enterprise, for example, individuals from underrepresented racial and ethnic groups, persons with disabilities, students from disadvantaged backgrounds, and women.  For more information, see ,the Notice of NIH's Interest in Diversity.  Describe planned activities such as topic specific institutional trainings and seminars for example, conflict management, inclusivity, communication, and implicit bias during the award to develop or enhance skills in working effectively with scientists from diverse backgrounds, including those from underrepresented groups,  and to promote inclusive and equitable scientific biomedical research environments. Please note that the race, ethnicity, or sex of the proposed candidate or other research personnel will not be considered in the application review process or when making funding decisions.  Please name the file “Inclusivity Candidate Statement.pdf”.

Applications lacking an Inclusivity Candidate Statement will be considered incomplete and will not be reviewed.

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 SF424 (R&R) 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 SF424 (R&R) 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 SF424 (R&R) Application Guide must be followed.

Candidates must carefully follow the SF424 (R&R) 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 SF424 (R&R) 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. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time.  If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the How to Apply - Application Guide.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. 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 SF424 (R&R) Application Guide. Paper applications will not be accepted.

Applicant organization 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 SF424 (R&R) 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. 

Candidates 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.

For this particular NOFO, note the following:

• An F99/K00 application has a research project that is integrated with the training plan. The review will emphasize the candidate’s scientific background and potential for a productive research career, the need for the proposed training, and the availability of science and scientific resources to accomplish the proposed goals.

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.

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact.

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical 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 NIDCR, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications will receive a written critique.

Applications may undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.

Applications will be assigned [on the basis of established PHS referral guidelines] to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Dental and Craniofacial Research Council. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

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

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.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the recipient's business official.

Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.      

Any application awarded in response to this NOFO will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.

Institutional Review Board or Independent Ethics Committee 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

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. 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, including of note, but not limited to:

• Federal-wide Standard Terms and Conditions for Research Grants
• Prohibition on Certain Telecommunications and Video Surveillance Services or Equipment
• Acknowledgment of Federal Funding

If a recipient is successful and receives a Notice of Award, 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.

If a recipient receives an award, the recipient must follow all applicable nondiscrimination laws. The recipient agrees to this when registering in SAM.gov. The recipient must also submit an Assurance of Compliance (HHS-690). To learn more, see the HHS Office for Civil Rights website. 

HHS recognizes that NIH research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this NOFO.

Transition to the Postdoctoral Career Development Phase (K00)

The F99/K00 award is intended to facilitate the successful transition from the predoctoral to the postdoctoral career stage. Consequently, a requirement for the K00 phase award is successful completion of the PhD or dual degree program and subsequent transition to a mentored postdoctoral research position. Researchers receiving support under F99 awards are encouraged to apply for postdoctoral positions in different environments from where they conducted their doctoral research to enhance the breadth of their scientific training and career development.  It is important for all those supported by F99 awards, but especially so for individuals who intend to stay at their predoctoral phase institution for the K00 postdoctoral phase, to provide a plan describing how the K00 research will lead to a research career trajectory independent of their PhD sponsor(s). Candidates are expected to identify a new mentor for the K00 phase of the award, although if strongly justified, the candidate’s F99 sponsor may continue to serve as the candidate’s K00 mentor.

The postdoctoral research advisor(s) will provide plans to promote the candidate’s research achievements, including publications, along with career development training in areas necessary for an independent research career, such as grant writing and laboratory management.

The transition from the predoctoral phase to the postdoctoral phase is intended to be continuous in time and, except in unusual circumstances, NIDCR will not extend the F99 phase. To begin the K00 award phase of the grant, individuals must have been offered and accepted a postdoctoral appointment to carry out DOC research. Upon starting the K00 phase of the award, the F99 phase of the award is terminated. Early transitions to the K00 phase of the award may be allowed on a case-by-case basis.

Individuals receiving support under F99 awards are strongly encouraged to contact the NIDCR Program Official as soon as an offer for a postdoctoral position develops, and not later than 6 months prior to the end of the F99 phase of the award.

An eligible K00 institution must have appropriate research related infrastructure and the mentor(s) must have sufficient funds and a history of external peer reviewed research awards to support the proposed postdoctoral research program.

Candidates may apply for postdoctoral positions within the NIH/NIDCR intramural research program (IRP).  However, should the individual accept such a position in the IRP, the postdoctoral phase will be supported directly by NIH intramural funds and the K00 will not be awarded, since NIH intramural scientists are not eligible to receive support from NIH extramural grant awards. The individual who accepted 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.

The K00 career development phase institution must submit application materials on behalf of the candidate for the K00 award, no later than 8 weeks prior to the proposed start of the K00 Award. The institution's Authorized Organizational Representative must email the application in PDF format to the NIDCR Financial or Grants Management contact person listed on the F99 Notice of Award.  The K00 application will be evaluated by NIDCR staff for completeness and responsiveness to the program.

Candidates who are not approved to transition will receive written notification from NIDCR communicating the rationale for the disapproval.  This notification typically will be sent within 60 days of receipt of the K00 application.

Although the NIDCR plans to provide financial support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds.

Instructions for the K00 Transition Award

F99 recipients wishing to submit a K00 transition application must follow the Career Development (K) Instructions in the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions except where instructed in this funding opportunity announcement to do otherwise, as described here.

The K00 Transition Application will include the following new or updated components:

• A new SF424(R&R) Cover Page Supplement Form signed by the K00 phase institutional representative;
• A Final Progress Report for the F99 phase;
• A final evaluation statement by the F99 primary sponsor;
• Updated K00 application components: 
  • Updated Project Summary and Abstract, Project Narrative, Bibliography & References Cited, Facilities & Other Resources, and Equipment section
  • Biographical sketches for candidate and from all members of the K00 mentoring team.  Candidates should use the Non-Fellowship Biosketch format (as such, Section D “Scholastic Performance” is not required).  The mentor(s) personal statement(s) should include a description of their mentoring and training philosophy, including commitment to fostering inclusive research training environments.
  • Budget: Detailed budget pages for a non-modular budget: 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;
• Updated sections of the PHS Career Development Award Supplemental Form, which should include:
  • A new Candidate Section. If applicable, include a discussion of non-research activities, such as clinical activities or clinical specialty training to be conducted at no more than 25% effort
  • Research Plan Section: The Specific Aims should be updated to reflect current plans for the K00 phase and the updated Research Strategy should be described in less than 5 pages;
  • A new Mentor, Co-Mentor, Consultant, Collaborators Section that includes a plan for fostering the candidate’s transition to the next stage of their career by the end of the K00 project award period.  Candidates are encouraged to identify more than one mentor, i.e., a mentor team, if this is deemed advantageous for their training program. The role of each mentor, co-mentor, consultant and collaborator (as applicable) in the K00 and commitment to the candidate should be clearly described.  When there is a mentor team, one individual must be identified as the primary mentor, and will be expected to coordinate the candidate’s overall K00 training. The primary mentor can be an independent investigator at any career stage, including an early-stage investigator. The mentor(s) should describe previous experience as a mentor. For all postdoctoral individuals mentored over the last 10 years, provide information on their time spent in the lab, their present employing organizations, and their present position titles or occupations. For early-career investigators, this may also include postdoctoral students that were mentored while the mentor was a senior postdoc or in a non-faculty position. Regardless of career stage, the mentor(s) should demonstrate a commitment to ensure the fellow receives tailored training that will facilitate their skills development and career advancement, describe their mentoring philosophies to support postdoctoral student success, and describe how any previous mentoring experience will support the success of the proposed project.  The mentor should discuss the availability of adequate resources and research support available for the K00 project.  For candidates transitioning to DOC research, discuss plans to provide a strong foundation in research design, methods and analytic techniques for the research area, and the relationship of the research training to DOC health and disease.
  • If the candidate is proposing to gain experience in a clinical trial as part of his or her research training, 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;
• Description of Institutional Environment section
• Institutional Commitment to Candidate’s Research Career Development Section:
  • 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. Describe the other activities, if applicable.
  • 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.
  • Describe efforts by the institution to foster e an inclusive research environment that promotes the success of individuals with a wide variety of backgrounds and experiences.  
  • 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 chairman of the department.
  • Updated Protections for Human Subjects, Inclusion of Individuals Across the Lifespan, and Inclusion of Women and Minorities (as appropriate);
  • Updated Other Research Plan Sections (as appropriate), including:
    • Vertebrate Animals;
    • Select Agent Research;
    • Resource Sharing; and
    • Authentication of Key Biological and/or Chemical Resources
  • Updated Plan for Training in the Responsible Conduct of Research,
  • A new checklist.

Termination of the F99 award phase

If the transition from the F99 phase to the K00 phase at an extramural institution occurs prior to the scheduled end date of the F99 award phase, then a revised Notice of Award will be issued to terminate the F99 phase award. Carry-over of unspent funds from a partially completed F99 phase year into the K00 phase is not permitted.

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

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

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

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

4. Reporting

When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement. The report is due two months before the beginning date of the next budget period and must include information describing the current year's progress as well as the research and training plans for the coming year.

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

The Federal Funding Accountability and Transparency Act of 2006 as amended (FFATA), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All recipients of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over the threshold. See the NIH Grants Policy Statement for additional information on this reporting requirement. 

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.

Within ten years of making awards under this program, NIDCR will assess the program’s overall outcomes, gauge its effectiveness in enhancing diversity, and consider whether there is a continuing need for the program.  Upon the completion of this evaluation, NIDCR 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:

F99

• Successful completion of graduate programs
• Transition to DOC postdoctoral research position
• Authorship of scientific publications in a DOC field
• Transition to the K00 phase

K00:

• Subsequent participation in a formal research training or career development program in a STEM field (e.g., K99/R00 award)
• Subsequent employment in a STEM field
• Authorship of scientific publications in a STEM field

Section VII. Agency Contacts

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

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

Finding Help Online: https://www.era.nih.gov/need-help (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-480-7075

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

Rachel Sare, Ph.D.
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: (301) 569-0273
Email: [email protected]

Yun Mei, Ph.D.
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: (301) 827-4639
Email: [email protected]

Gabriel Hidalgo, M.B.A.
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-827-4630
Email: [email protected]

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

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.