Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute of Dental and Craniofacial Research (NIDCR)

Funding Opportunity Title
NIDCR Dual Degree Dentist Scientist Predoctoral to Postdoctoral Transition Award (F99/K00 Independent Clinical Trial Not Allowed)
Activity Code

F99/K00 Pre-doc to Post-doc Transition Award/Post-doctoral Transition Award

Announcement Type
Reissue of PAR-21-108
Related Notices

    See Notices of Special Interest associated with this funding opportunity

  • October 21, 2024 - Notice of NIDCR Pre-Application and Technical Assistance Webinar on Applying for Fellowship (F) Awards. See Notice NOT-DE-25-042.
  • August 31, 2022 - Implementation Changes for Genomic Data Sharing Plans Included with Applications Due on or after January 25, 2023. See Notice NOT-OD-22-198.
  • August 5, 2022 - Implementation Details for the NIH Data Management and Sharing Policy. See Notice NOT-OD-22-189.
Funding Opportunity Number (FON)
PAR-25-021
Companion Notice of Funding Opportunity
None
Number of Applications

See Section III. 3. Additional Information on Eligibility.

Assistance Listing Number(s)
93.121
Funding Opportunity Purpose

The purpose of the NIDCR Dual Degree Dentist Scientist Predoctoral to Postdoctoral Transition Award (F99/K00) is to provide support and mentorship to graduate students enrolled in integrated dual degree dental (DDS/DMD) and PhD programs during the transition from predoctoral student to postdoctoral scholar.  This phased award will facilitate completion of predoctoral dual degree dentist scientist training (F99) and ensure transition to mentored postdoctoral positions in dental, oral, and craniofacial (DOC) research (K00).  It is anticipated that successful completion of this phased award program will enhance dual degree dentist scientists’ research career trajectories.

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

Key Dates

Posted Date
May 21, 2024
Open Date (Earliest Submission Date)
July 08, 2024
Letter of Intent Due Date(s)

Not Applicable

The following table includes NIH standard due dates marked with an asterisk.
Application Due Dates Review and Award Cycles
New Renewal / Resubmission / Revision (as allowed) AIDS - New/Renewal/Resubmission/Revision, as allowed Scientific Merit Review Advisory Council Review Earliest Start Date
August 08, 2024 * August 08, 2024 * September 07, 2024 * November 2024 January 2025 April 2025
December 08, 2024 * December 08, 2024 * January 07, 2025 * March 2025 May 2025 July 2025
April 08, 2025 * April 08, 2025 * May 07, 2025 * July 2025 October 2025 December 2025
August 08, 2025 * August 08, 2025 * September 07, 2025 * November 2025 January 2026 April 2026
December 08, 2025 * December 08, 2025 * January 07, 2026 * March 2026 May 2026 July 2026
April 08, 2026 * April 08, 2026 * May 07, 2026 * July 2026 October 2026 December 2026
August 08, 2026 * August 08, 2026 * September 07, 2026 * November 2026 January 2027 April 2027
December 08, 2026 * December 08, 2026 * January 07, 2027 * March 2027 May 2027 July 2027
April 08, 2027 * April 08, 2027 * May 07, 2027 * July 2027 October 2027 December 2027

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

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

Expiration Date
May 08, 2027
Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

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 How to Apply - Application Guide and the NOFO) is required and strictly enforced. Applicants 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.


  4. Table of Contents

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

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

The purpose of the NIDCR Dual Degree Dentist Scientist Predoctoral to Postdoctoral Transition Award (F99/K00) is to support the transition from predoctoral dual degree DDS/DMD-PhD student to postdoctoral scholar in DOC research.  This program is intended to  retain dentist scientists in the DOC research workforce and enhance their progression to independent research careers.

Background

NIDCR invests in integrated predoctoral dual degree DDS/DMS and PhD training to develop a dentist scientist workforce with the unique abilities to incorporate basic and clinical perspectives into DOC research.

Following completion of predoctoral dual degree training programs, dentist scientists can find it challenging to transition to postdoctoral research positions.  Clinician scientists particularly benefit from mentorship across career stage transitions (Permar et. al. 2020).  High levels of educational debt from combined degree programs and low postdoctoral salaries can serve as disincentives to research career progression (D Souza et. al. 2017Physician Scientist Workforce Report, 2014).  Research intensive faculty positions in most dental schools require rigorous postdoctoral training and/or clinical dental specialty training (Physician Scientist Workforce Report, 2014).  Dual degree dentist scientists often struggle to identify institutional support and mentorship to enable them to balance research training with subsequent specialty training or continued engagement in clinical dentistry.

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 predoctoral training for individuals enrolled in integrated dual degree dentist scientists’ programs in the United States.  During the F99 phase, students are expected to complete their dual degree training, identify postdoctoral research mentor(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.  During the K00 phase, a minimum of 75% effort must be dedicated to K00 research career development; up to 25% effort is allowed for clinical activities or customized part-time dental specialty training.  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 individuals  who have successfully completed dual 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 program is expected to enhance the research career trajectories of dual degree DDS/DMD-PhD dentist scientists and foster progression to research independence.  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.  The F99/K00 program is intended to complement the spectrum of research training and career development opportunities for dentist scientists.  For more information on NIDCR opportunities for dentists, see: https://www.nidcr.nih.gov/careers-training/interns-fellows/dentists-physicians.

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

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

Section II. Award Information

Funding Instrument

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

Application Types Allowed
New
Resubmission

The OER Glossary and the How to Apply - Application Guide provide details on these application types. Only those application types listed here are allowed for this NOFO.

Clinical Trial?

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

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

Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

Award Budget

For the F99 phase, award budgets are composed of stipends, tuition and fees, and institutional allowance, as described below. For the K00 phase, award budgets are composed of salaries and fringe benefits, research and career development support, and indirect costs, as described below.

Award Project Period

For the F99/K00 award, individuals may receive up to 5 years combined support for both phases, which includes a minimum of 1 year and up to 2 years in the F99 fellowship phase and up to 3 years in the K00 career development phase.

Other Award Budget Information

Stipends

ALLOWABLE COSTS F99 PHASE:

Stipends are provided as a subsistence allowance to help defray living expenses during the research training experience.  NIDCR will contribute to the F99 stipend levels commensurate with F30 Ruth L. Kirschstein National Research Service Award (NRSA) fellows. See https://researchtraining.nih.gov/resources/policy-notices for more information.

ALLOWABLE COSTS K00 PHASE:

NIDCR will contribute up to $75,000 toward the salary of the career award recipient.  The requested salary must be based on a full-time staff appointment consistent both with the established salary structure at the institution and with salaries actually provided by the institution from its own funds to other staff members with equivalent qualifications, rank, and responsibilities in the department concerned.  Further guidance on budgeting for career development salaries is provided in the SF424 (R&R) Application Guide.  Fringe benefits, based on the sponsoring institution's rate and the percent of effort, are provided in addition to salary.  The total salary, however, may not exceed the legislatively mandated salary cap.

Tuition and Fees

ALLOWABLE COSTS: F99 PHASE NDCR will contribute to the combined cost of tuition and fees at the rate in place at the time of award, at the same level set for the F30 Ruth L. Kirschstein National Research Service Award (NRSA) fellowships. See https://researchtraining.nih.gov/resources/policy-notices for more information. 

Institutional Allowance

ALLOWABLE COSTS: F99 PHASE

The candidate 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 F30 Ruth L. Kirschstein National Research Service Award (NRSA) award. See: https://researchtraining.nih.gov/resources/policy-notices.

ALLOWABLE COSTS: K00 PHASE

The NIDCR will provide up to $10,000 per year towards the research development support for the award recipient, which must be justified and consistent with the stage of development of the candidate and the proportion of time to be spent in research or career development activities.  These costs may be used for the following expenses: (a) tuition and fees related to career development; (b) research expenses, such as supplies, equipment and technical personnel; c) travel to research meetings or training; and (d) statistical services including personnel and computer time.  Research development costs must be justified and consistent with the stage of development of the candidate and the proportion of time to be spent in research or career development activities.  Salary for mentors, secretarial and administrative assistants, etc. is not allowed.

Indirect Costs

NIH does not separately reimburse indirect costs (also known as Facilities & Administrative [F&A] Costs) for fellowships. Costs for administering the F99 awards are part of the Institutional Allowance. See https://researchtraining.nih.gov/resources/policy-notices.

 ALLOWABLE COSTS: K00 PHASE Indirect Costs (also known as Facilities & Administrative [F&A] Costs) are reimbursed at 8% of modified total direct costs.

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

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this NOFO.

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

  • 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
Other
  • None

F99 Eligibility: All domestic combined DDS/DMD and 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 for 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 an 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 not allowed.

Required Registrations

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the How to Apply - Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so 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.
  • 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.

Eligible Individuals (Program Director/Principal Investigator)

Any applicant fellow 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. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. Multiple PDs/PIs are not allowed. 

Multiple PDs/PIs are not allowed.

The candidate must be currently enrolled in a combined, dual-degree training leading to award of both a dental degree (DDS, DMD) and a research doctoral degree (PhD) from an accredited United States Program.  To be eligible, over the total duration of the dual degree training program, at least 50% of the program must be devoted to full-time graduate research training leading to the doctoral research degree.  At the time of award, the candidate is expected to require at least one year, but no more than 2 years to complete their dual-degree training (F99 phase) before transitioning to mentored postdoctoral research training (K00 phase).  If an applicant completes all doctoral dissertation requirements or begins a postdoctoral position before an F99 award is issued, neither the F99 nor the K00 will be awarded.

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 an application.

A candidate may be a citizen or a non citizen national of the United States, 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), or be a non-U.S. citizen with a valid U.S. visa. For applications submitted on behalf of non-U.S. citizens with valid U.S. visas, the visa status during each phase of the F99/K00 award must allow the PD/PI to conduct the proposed research at the applicant institution.  For the F99 phase of the award, the applicant F99 institution is responsible for determining and documenting that the candidate’s visa will allow the candidate to remain in the U.S. to complete the F99 phase of the award, and that there are no known obstacles that would prevent the candidate from obtaining a visa for the K00 phase.  For the K00 phase of the award, the U.S. institution at which the K00 phase of the award will be conducted is responsible for determining and documenting, in the transition application, that the K00 PD/PI’s visa will allow the PD/PI to remain in the U.S. for the duration of the K00 award.  NIDCR may request verifying information as part of the pre-award process.

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 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, 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.

Duration of Support

Individuals may not exceed the aggregate limit of NRSA support shown above in the Award Project Period (see Section II. Award Information). Candidates must consider any prior NRSA research training in determining the duration of support requested. Information regarding previous Kirschstein-NRSA support must be included in the application and will be considered at the time of award.

Level of Effort

F99 recipients are required to pursue their dual-degree 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. To be eligible, over the total duration of the dual degree training program, at least 50% of the program must be devoted to full-time graduate research training leading to the PhD research degree. K00 recipients 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. 

K00 recipients 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.

Sponsor

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., 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 knowledge and 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 How to Apply - Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Page Limitations

All page limitations described in the How to Apply - Application Guide and the Table of Page Limits must be followed.

Instructions for Application Submission

The following section supplements the instructions found in the How to Apply - Application Guide and should be used for preparing an application to this NOFO.

Instructions for Application Submission
SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

Other Project Information

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

SF424(R&R) Senior/Key Person Profile Expanded

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

IMPORTANT REMINDER: The personal profile associated with the eRA Commons username entered in the Credential field for the PD/PI (fellowship 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 commitment to a scientific career.

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.

PHS Fellowship Supplemental Form

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 How to Apply - Application Guide must be followed.

Fellowship Applicant Section

Candidate’s Background and Goals for Fellowship Training

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, as applicable.

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.  Discuss how the proposed integrated F99 research and clinical training plan will enhance knowledge and technical, clinical and professional skills as a dentist scientist, and facilitate transition to the K00 career development phase.

Training Goals and Objectives

Describe short-term and long-term goals for a dentist scientist research career and explain how the F99/K00 will enable the attainment of these goals.  Also include plans to apply 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. For the F99 phase, indicate the estimated percentage of time that will be devoted to clinical  and research-related activities during each year of the award.  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/organization.  Describe the desirable mentor qualifications and attributes as well as the institutional environment needed to perform the anticipated K00 phase research.  Candidates are strongly encouraged to discuss how they will identify a mentor or co-mentor who is a dentist scientist.

Research Training Plan

Specific Aims:

All candidates must use these two Specific Aims:

  • Specific Aim 1: The F99 Research Project (typically the applicant’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  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 completing 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 are 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, description of how robust and unbiased results will be achieved, 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 pursued 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 How to Apply - 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.

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 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, certifications, 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.

Institutional Environment and Commitment to Training Section

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 harassment/abusive behavior; and
  • 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.

Appendix

Limited items are allowed in the Appendix.  Follow all instructions for the Appendix as described in the How to Apply - Application Guide; any instructions provided here are in addition to the How to Apply - Application Guide instructions.

PHS Human Subjects and Clinical Trials Information

When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the How to Apply - Application Guide, with the following additional instructions:

If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record. 

Study Record: PHS Human Subjects and Clinical Trials Information

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

  • Do not provide an NCT# in Section 1, item 1.5. See instruction for Sponsor(s), Collaborator(s), and Consultant(s) above.
  • Do not complete Section 4 - Protocol Synopsis information or Section 5 - Other Clinical Trial-related Attachments.

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described, but will not start immediately (i.e., delayed start). 

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

PHS Assignment Request Form

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

Reference Letters

Applicants 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. 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 How to Apply - Application Guide. Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply – Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

All PD(s)/PI(s) 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. 

Post Submission Materials

Applicants 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 DOC research career, the need for the proposed research  training, and the availability of science and scientific resources to accomplish the proposed goals.
Overall Impact

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

Scored 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.

 
  • Based on the candidate’s knowledge, skills, experiences, and described training goals, is the candidate appropriately prepared to carry out the Research Training Plan?
  • Does the candidate have the potential to develop into an independent and productive DOC researcher?
  • Does the candidate demonstrate commitment to a research career in DOC research in the future?
  • Do the letters of reference provide evidence that the candidate has both a strong commitment to and high potential for becoming an independent research investigator?
  • Does the candidate demonstrate potential for successful transition to a strong postdoctoral position in DOC research (K00 phase)?
 
  • Are the F99 sponsor(s) research qualifications (including recent publications) and mentor experience of trainees at a similar career stage and philosophy appropriate for the needs of the candidate?
  • Will the F99 sponsor(s) be able to provide the knowledge and scientific guidance necessary for the candidate to complete the proposed project?
  • Is there evidence of alignment between the research and clinical interests of the candidate and the sponsor(s)? Do(es) the sponsor(s) demonstrate an understanding of the candidate’s training needs as well as the ability and commitment to assist in meeting these needs?
  • Is there evidence of adequate research funds to support the candidate’s proposed research project and training for the duration of the F99 phase?
  • If a team of sponsors (co-sponsors) is proposed, is the team structure well justified for the mentored training plan, does their expertise complement the proposed training plan, and are the roles of the individual members appropriate and clearly defined?
  • Have the sponsor(s) provided a strong mentorship plan with provisions for monitoring and evaluating the candidate's F99 research and career development progress?
  • Does the sponsor(s) have a clear commitment ensuring the research environment is inclusive, safe and supportive to trainees from all backgrounds?
  • If the research direction for the K00 phase is outside the primary sponsor's expertise, are there adequate plans to provide the candidate with a foundation for the K00 postdoctoral research phase?
  • If the candidate is proposing to gain experience in a clinical trial as part of their research training, is there evidence of the appropriate expertise, experience, resources, and ability on the part of the sponsor(s) to guide the candidate during the clinical trial research experience?
 
  • Does the research proposed in the F99 and K00 phases address an important problem or a critical barrier to progress in the field?
  • Is the proposed F99 research project scientifically sound, feasible, and well-integrated with the proposed training plan?
  • Is the prior research that serves as the key support for the proposed project rigorous?
  • Has the candidate included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project?
  • Has the candidate presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed?
  • Has the candidate presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?
  • Does the discussion of expected results, and potential pitfalls and alternative outcomes provide confidence that, if an important component of the research is unsuccessful, the candidate is likely to have a viable direction for continuing the project?
  • Based on the sponsor’s description of the active research program, is the candidate’s proposed F99 research project sufficiently distinct from the sponsor’s funded research for the candidate’s career stage?
  • Is the proposed time frame feasible to accomplish the proposed research training program (F99) and transition to the career development phase (K00)?
  • Is the research direction of the career development phase (K00) appropriate to the candidate's anticipated stage of development and likely to promote the candidate's DOC research career?
  • If proposed, will the clinical trial experience contribute to the proposed project and/or the candidate’s research training?
 
  • Are the proposed research project and training plan likely to provide the candidate with the requisite individualized and mentored experiences in order to obtain appropriate skills for a research career?
  • Does the training plan take advantage of the candidate’s strengths and address gaps in needed skills? Does the training plan document a clear need for, and value of, the proposed training?
  • Does the proposed training have the potential to serve as a sound foundation that will clearly enhance the candidate’s ability to develop into an independent investigator?
  • Does the training plan in the fellowship phase (F99) provide an appropriate foundation for transition to the career development phase (K00) of the award?
  • Have the candidate and F99 sponsor(s) provided a strong plan for identifying career development phase (K00) mentors(s) with appropriate expertise and qualifications?
  • Have the candidate and sponsor(s) provided appropriate milestones in terms of research achievements, professional and career skills for transition to the career development phase (K00) of the award?
 
  • Are the research facilities, resources (e.g., equipment, laboratory space, computer time, subject populations), and training opportunities (e.g., seminars, workshops, professional development opportunities) adequate and appropriate?
  • Are the institutional commitment and resources likely to foster the candidate’s mentored research training and career development?
  • Is adequate evidence provided that the F99-sponsoring institution is strongly committed to fostering the candidate's development and preparation for transition to the career development phase (K00)?
  • Is there a clear institutional commitment to develop and promote a culture in which scientific rigor, reproducibility, and responsible conduct of research are advanced?
Additional Review Criteria

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.

 

For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

 

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

 

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animals Section.

 

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

 

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

 

Not Allowed 

 

Not Allowed

Additional Review Considerations

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

 

All applications for support under this NOFO must include a plan to fulfill NIH requirements for Instruction in the Responsible Conduct of Research (RCR). Taking into account the level of experience of the candidate, including any prior instruction or participation in RCR as appropriate for the candidate’s career stage, the reviewers will evaluate the adequacy of the proposed RCR training in relation to the following five required components: 1) Format - the required format of instruction, i.e., face-to-face lectures, coursework, and/or real-time discussion groups (a plan with only on-line instruction is not acceptable); 2) Subject Matter - the breadth of subject matter, e.g., conflict of interest, authorship, data management, human subjects and animal use, laboratory safety, research misconduct, research ethics; 3) Faculty Participation - the role of the sponsor(s) and other faculty involvement in the fellow’s instruction; 4) Duration of Instruction - the number of contact hours of instruction (at least eight contact hours are required); and 5) Frequency of Instruction – instruction must occur during each career stage and at least once every four years. Plans and past record will be rated as ACCEPTABLE or UNACCEPTABLE, and the summary statement will provide the consensus of the review committee. See also: NOT-OD-10-019 and NOT-OD-22-055.

 

Not Applicable

 

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

 

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1)Data Sharing Plan; 2)Sharing Model Organisms; and 3)Genomic Data Sharing Plan.

 

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

 

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by NIDCR, 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 scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.

Appeals of initial peer review will not be accepted for applications submitted in response to this NOFO.

Applications will be assigned 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 NIDCR National Advisory 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. This request is not a Notice of Award nor should be construed to be an indicator of possible funding. 

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.

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:

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 Laws and Regulations Enforced by the HHS Office for Civil Rights website

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

Transition to the Postdoctoral Career Development K00 Phase

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 dual degree program and subsequent transition to a mentored postdoctoral research position. F99 recipients 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 F99 recipients , 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). K00 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 position  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.

F99 recipients 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 for 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.

K00 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 an inclusive, accessible, safe and supportive research training environment.
  • 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 5 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.  Expand on efforts by the mentor/co-mentor to enhance an inclusive, accessible, safe and supportive research training environment free from harassment, etc.   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.
    • 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.

Inventions and Copyrights

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

3. Data Management and Sharing

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.

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, gauge its effectiveness in  achieving program goals , 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:

F99

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

K00:

  • Subsequent participation in postdoctoral research or career development program in a STEM field (e.g., mentored K, K99/R00 award)
  • Subsequent employment in DOC research or other biomedical or STEM field
  • Authorship of scientific publications in a DOC, biomedical or other STEM field

Section VII. Agency Contacts

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

Application Submission Contacts

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

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

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-637-3015

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

Scientific/Research Contact(s)

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

Peer Review Contact(s)

Yasaman Shirazi, Ph.D.
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-594-5593
Email: [email protected]

Financial/Grants Management Contact(s)

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.

Authority and Regulations

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.

NIH Office of Extramural Research Logo
Department of Health and Human Services (HHS) - Home Page
Department of Health
and Human Services (HHS)
USA.gov - Government Made Easy
NIH... Turning Discovery Into Health®