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

New

Related Notices

None

Funding Opportunity Announcement (FOA) Number
PAR-21-108
Companion Funding Opportunity

None

Catalog of Federal Domestic Assistance (CFDA) 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 outstanding students enrolled in integrated dual degree dental (DDS/DMD) and PhD programs during the transition from predoctoral student to postdoctoral scholar. This phased award program will facilitate completion of predoctoral dual degree dentist scientist training (F99) and progression to mentored postdoctoral positions in dental, oral and craniofacial research (K00). It is anticipated that successful completion of this phased award program will enhance dual degree dentist scientists' research career trajectories

This Funding Opportunity Announcement (FOA) 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
January 14, 2021
Open Date (Earliest Submission Date)
March 08, 2021
Letter of Intent Due Date(s)

Not Applicable

Application Due Date(s)

Standard dates apply. The first application due date is April 8, 2021.

All applications are due by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on the listed date(s).

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.

AIDS Application Due Date(s)

Standard AIDS dates apply.

All applications are due by 5:00 PM local time of applicant organization. All types of AIDS and AIDS-related applications allowed for this funding opportunity announcement are due on the listed date(s).

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.

Scientific Merit Review
Advisory Council Review
Earliest Start Date
Expiration Date
January 08, 2024
Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the Fellowship (F) instructions in the SF424 (R&R) Application Guide except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) 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.


  4. Table of Contents

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

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

Background

NIDCR invests in integrated predoctoral dual degree DDS/DMD and PhD training to develop a dentist scientist workforce with the unique abilities to incorporate basic and clinical perspectives into dental, oral and craniofacial health research.

Following completion of predoctoral dual degree training programs, dentist-scientists can find it challenging to transition to postdoctoral research training 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. 2017, Physician Scientist Workforce Report, 2014). Research intensive faculty positions in most dental schools require rigorous postdoctoral research 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.

The NIDCR F99/K00 award is intended to provide individualized mentorship over the transition from predoctoral student to postdoctoral researcher through two continuous phases of support. The first phase (F99) will support up to 2 years of predoctoral training at 100% effort for individuals enrolled in integrated dual degree dentist scientist programs in the United States. During this phase, students are expected to complete their dental DDS/DMD and PhD training, identify postdoctoral research mentor(s) distinct from their primary dissertation advisor(s), and work with these mentors to develop a postdoctoral research project in a field directly related to the NIDCR Mission and NIDCR grant programs. The second phase (K00) will provide up to 3 years of mentored postdoctoral research career development support. 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 or postdoctoral institutions at the time of application. Prior to the anticipated time of transition, F99 awardees are encouraged to apply for postdoctoral positions at departments and institutions different from where they conducted their graduate research. The K00 award phase can be activated only after the F99 awardee has successfully completed doctoral degree requirements and the F99 research training program, secured a postdoctoral position in dental, oral, and craniofacial research, and, in collaboration with the K00 mentorship team and sponsoring institution, provided NIDCR with a K00 research training and career development plan that will facilitate an independent dental, oral, and craniofacial research career.

This program is expected to enhance the research career trajectories of dual degree dentist scientists and foster progression to research independence. K00 awardees remain eligible to apply to subsequent mentored Career Development (K) and Pathway to Independence (K99/R00) award programs. 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 Funding Opportunity Announcement (FOA) 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.

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

Section II. Award Information

Funding Instrument

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

Application Types Allowed
Resubmission
New

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA.

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

PA/PAR: 

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 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(F99)/Salary(K00)

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 cost of the F99 stipend at the rate commensurate with the recent F30 level allowable under the Ruth L. Kirschstein National Research Service Award (NRSA), K00 PHASE NIDCR will contribute up to $75,000 toward the salary of the career award recipient. The requested salary must be 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.

Tuition and Fees

F99 PHASE

NIDCR will contribute to the combined cost of tuition and fees at the rate in place at the time of award, at the same levels set for predoctoral dual degree students under Ruth L. Kirschstein National Research Service Awards (NRSA). See: https://researchtraining.nih.gov/resources/policy-notices.

Institutional Allowance (F99)/Other Program Related Expenses (K00)

ALLOWABLE COSTS:
F99 PHASE The applicant 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) awards. See: https://researchtraining.nih.gov/resources/policy-notices.

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

Indirect Costs

ALLOWABLE COSTS: F99 PHASE

 

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 FOA.

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 applications. 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 F99 awardees. Note, if an F99 awardee accepts a postdoctoral position in the NIH intramural research program, 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.

Before submitting an F99/K00 application, the applicant 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 and is demonstrably committed to training in the field(s) proposed by the applicant. All institutions with the appropriate resources and commitment are encouraged to apply.

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) 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.

Required Registrations

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. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

  • Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
  • 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.
  • eRA Commons - Applicants must have an active DUNS number to register in eRA Commons. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration, but 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 DUNS number and 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 his/her sponsor and organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support. Multiple PDs/PIs are not allowed.

The candidate must be 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. The candidate must show evidence of high academic performance in the sciences, and commitment to a research career.

At the time of F99 award, the candidate is expected to require no more than 2 years to complete all DDS/DMD and PhD degree requirements. 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.

Individuals who are currently being supported under an F30 are eligible to apply for this program; however, they must relinquish the F30 if they choose to accept the F99 award. Individuals who receive F99/K00 support remain eligible and are encouraged to apply for subsequent individual career development awards (e.g. K01, K08, K23) and Pathway to Independence awards (K99/R00) provided they meet eligibility requirements.

An applicant may be a citizen or a noncitizen 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 applicant's visa will allow the applicant 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 applicant 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.

2. Cost Sharing

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

3. Additional Information on Eligibility

Number of Applications

The NIH will not accept duplicate or highly overlapping applications under review at the same time.  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 NOT-OD-11-101).
Duration of Support

Individuals may not exceed the aggregate limit of support shown above in the Award Project Period (See Section II. Award Information).

Level of Effort

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.

F99 awardees may submit an application for the second phase K00 when they have identified a postdoctoral position. K00 awardees are required to have a full-time appointment at the K00 applicant institution, and to commit a minimum of 9 person months (or 75% of their full-time professional effort at the applicant institution) to their career development and research training. K00 awardees may engage in other duties (e.g., other research, dental specialty training, clinical and teaching activities) as part of the remaining 25% effort not covered by the award, as long as such duties do not interfere with or detract from the proposed career development program.

Sponsor

Before submitting the application, the candidate must identify F99 phase sponsor(s) who will supervise the proposed mentored training experience. Candidates are encouraged to identify more than one sponsor, i.e., a sponsor team, if this is deemed advantageous for their training program. When there is a sponsor team, one individual must be identified as the primary sponsor, and will be expected to coordinate the candidate’s overall training. The F99 sponsor(s) should provide support and guidance to the applicant during the search for a postdoctoral research position and transition to the postdoctoral career development phase (K00). A dentist scientist co-sponsor or consultant, in an area of clinical interest to the candidate is encouraged. This individual would meet regularly to help collaboratively mentor the candidate during the F99 phase.

A postdoctoral research mentor is not required at the time of application for the F99 phase of the F99/K00 award. Postdoctoral research mentors will be identified in a postdoctoral transition application and prior to activation of the second award phase (K00). Applicants are strongly encouraged to include a dentist scientist mentor or co-mentor in the K00 mentorship team. The primary sponsor should be an active investigator in the area of the proposed research training and be committed both to the candidate’s research training and to direct supervision of his/her research. The primary sponsor must document the availability of sufficient research funds and facilities for high-quality research training. The primary sponsor, or a member of the sponsor team, should have a successful track record of mentorship at the predoctoral level. The candidate must work with the primary sponsor(s) in preparing the application.

Section IV. Application and Submission Information

1. Requesting an Application Package

The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this FOA. 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 SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement 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.

Page Limitations
All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.
Instructions for Application Submission

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

Instructions for Application Submission
SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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.

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

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.

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

Fellowship Applicant Section

Applicant’s Background and Goals for Fellowship Training

Doctoral Dissertation and Research Experience

Include a description of how the combination of past research experiences and the F99/K00 plans contribute to achieving the long-term career goal of becoming an independent 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.

For each phase, describe how the proposed research training and career development plan will enhance the applicant's knowledge, technical expertise, and professional skills, including manuscript and grant writing, laboratory management, and supervisory and mentorship skills, keeping in mind existing strengths as well as any gaps in existing knowledge and skills. If the K00 research direction is markedly 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 a K00 postdoctoral fellowship.

Discuss longer-term goals for research and career development as a dentist scientist following the conclusion of F99/K00 support, such as an individual K award application.

Activities Planned Under This Award

Describe the scientific and professional development activities planned for both the F99 and K00 phase and explain how the activities will facilitate the transition to the subsequent career stage of each phase and ultimately, establishment of an independent dental, oral, and craniofacial research career. Identify the skills, theories, conceptual approaches, etc., to be learned or enhanced during the award, including expertise in rigorous research design, experimental methods, quantitative approaches, and data analysis and interpretation, as applicable. Include a timeline with scientific, professional development, and career milestones that spans the entire award period.  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 career development 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 dental, oral, and craniofacial research area of focus and K00 phase institution. Describe the desirable mentor qualifications and attributes as well as the institutional environment needed to perform the K00 phase research. Applicants are strongly encouraged to discuss how they will identify a mentor or co-mentor who is a dentist scientist.

Research Training Plan

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

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. Discuss how the proposed project will improve scientific knowledge, technical capability, and/or clinical practice in one or more broad fields.
  • 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.
  • Describe how the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field will be changed if the proposed aims are achieved.

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:

1. A progress report on the dissertation research project thus far, including the approaches used, research outcomes obtained, and important methodologies learned.

2. A detailed research proposal for the work to be completed in the F99 phase, including experimental design, anticipated results, potential problems, alternative strategies, and potential follow-up studies. Describe plans to address weaknesses in the rigor of the prior research that serves as the key support for the proposed project. Describe the experimental design and methods proposed and how they will achieve robust and unbiased results.

Specific Aim 2 (K00):

Significance

Identify a broad 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 can advance or address unanswered questions in dental, oral, or craniofacial research. 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 or research direction.

Approach

Provide a general description of the research project or direction for the K00 phase including, as appropriate, potential experimental approaches and methodologies, anticipated results, potential challenges and alternative strategies. Explain how prior training, especially if the K00 is associated with research redirection, can establish a foundation for an independent research career. Discuss how the K00 research training and career development will enable the applicant to develop scientific and career skills and facilitate next steps for an independent research career. Describe the mentorship expertise and institutional environment that could support these studies.

If the applicant 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

  • Follow instructions for Sections A-E as directed for the F30.
  • Include the following additional information in section C:
    • The F99 sponsor and any co-sponsor(s) should discuss how they will support the applicant's transition to the K00 phase and how the applicant's clinical training, research and career development progress will be monitored and evaluated throughout the F99 phase.
    • The F99 sponsor and any co-sponsor(s) should also discuss how they will ensure that the candidate will be best prepared for a career as a dentist scientist, including any interactions with established dentist scientist researchers.
    • If the K00 research field is outside of the primary F99 sponsor's expertise, discuss plans to provide the candidate with a foundation for the K00 research direction. This may be through interactions with co-sponsors, consultants and other career development activities.
  • In section E, the sponsor and any co-sponsor(s) for the F99 should also discuss the applicant's qualifications and potential for transitioning to the K00 postdoctoral phase and for pursuing a long term career as a dentist scientist.
  • The sponsor should also describe the roles and responsibility that both he/she and the fellow are undertaking, including contributions to the F99 research plan, the portion of the F99 research ideas and plan that originated with the applicant, and the relationship between the proposed research plan and funded or unfunded research projects previously devised by the sponsor.
  • If the applicant is proposing to gain experience in a clinical trial as part of his or her research training, the sponsor or co-sponsor must include a statement to document leadership of the clinical trial including source of funding, NCT# and appropriate expertise to guide the applicant in any proposed clinical trials research experience. The individual receiving support for the clinical trial (i.e., the sponsor/primary mentor or a co-sponsor) is the responsible individual of record for oversight of the trial, although fellows can take part in all components of a clinical trial. Oversight includes (but is not limited to): interacting with relevant Institutional Review Board (IRB) staff; reviewing all informed consent documents; reporting potential serious adverse events; and maintaining responsibility for patient safety. However, the fellow can gain experience in all these components in conjunction with the mentor or individual leading the trial.

Institutional Environment and Commitment to Training Section

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

Description of Institutional Environment and Commitment to Training

  • Follow the instructions for F30 applications with the following additional information:
  • Confirm that applicant is on track to complete all degree requirements of the dual degree DDS/DMD-PhD program, and within two years of the F99 award start date.
  • Discuss plans to support the candidate during completion of the degree program and during the search for a K00 postdoctoral fellowship.

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.

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 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.

PHS Assignment Request Form
All instructions in the SF424 (R&R) Application Guide must be followed.
Reference Letters

Applicants 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.

3. Unique Entity Identifier and System for Award Management (SAM)

See Part 1. 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. Overview Information 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 Policy on Late Application Submission.

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 SF424 (R&R) 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.

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.

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) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. 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 DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management (SAM). 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.

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 announcement, note the following:

  • A fellowship application has a research project that is integrated with the training plan. The review will emphasize the applicant’s potential for a productive career, the applicant’s need for the proposed training, and the degree to which the research project and training plan, the sponsor(s), and the environment will satisfy those needs.
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.

 
  • Are the candidate's academic record and research experience of high quality?
  • Does the candidate have the potential to develop into an independent and productive researcher?
  • Does the candidate demonstrate commitment to a research career in the future?
  • Does the research project reflect a significant contribution of the candidate to the originality of the project idea, approach and/or hypotheses relative to the career stage of the applicant?
  •  Does the candidate demonstrate potential for successful transition to a strong postdoctoral position in dental, oral and craniofacial research (K00 phase)?

 
  • Are the F99 sponsor(s’) research qualifications (including recent publications) and track record of mentoring individuals at a similar stage appropriate for the needs of the candidate?
  • Is there evidence of a match between the research and clinical interests (if applicable) of the candidate and the F99 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 research component of the F99?
  • If a team of sponsors is proposed, is the team structure well justified for the mentored training plan, and are the roles of the individual members appropriate and clearly defined?
  • Are the qualifications of any collaborator(s) and/or consultant(s), including their complementary expertise and previous experience in fostering the training of fellows, appropriate for the proposed project?
  • Does the sponsor's research and training record, as well as mentoring statement, indicate that the candidate will receive outstanding training in the proposed research area and have the opportunity to publish high quality papers and present research data at national meetings as the project progresses?
  •  If the research direction for the K00 phase is outside of the primary sponsor's expertise, are adequate plans presented to provide the candidate with a foundation for the K00 postdoctoral research?

  • If the applicant is proposing to gain experience in a clinical trial as part of his or her research training, is there evidence of the appropriate expertise, experience, resources, and ability on the part of the sponsor(s) to guide the applicant during the clinical trial research experience?
 
  • Is the proposed research project of high scientific quality, and is it well integrated with the proposed research training plan?
  • Is the prior research that serves as the key support for the 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?
  • Based on the sponsor’s description of his/her active research program, is the candidate’s proposed research project sufficiently distinct from the sponsor’s funded research for the candidate’s career stage?
  • Is the research project consistent with the candidate’s stage of research development?
  • Is the proposed time frame feasible to accomplish the proposed training?
  • If proposed, will the clinical trial experience contribute to the proposed project and/or the applicant’s research training?
  • Is the training plan well-reasoned, and likely to provide an effective, integrated research and clinical training experience to complete the F99 phase dual-degree program and promote transition to the K00 phase?
  •  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 independent dental, oral and craniofacial research career?
 
  • 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 a productive researcher?
  • If applicable to the dual-degree program, are appropriate opportunities for electives, early and longitudinal clinical experiences, or other enhanced clinical training available to the candidate? Are appropriate opportunities available to ease the transition to clinical clerkships and for research electives during clinical training?
  • 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 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 F99 research facilities, resources (e.g., equipment, laboratory space, computer time, subject populations, clinical training settings) and training opportunities (e.g. seminars, workshops, professional development opportunities) adequate and appropriate?
  • Is the F99 institutional environment for the candidate’s scientific and clinical development of high quality? Are the facilities and resources appropriate to provide exposure to a research-oriented, clinical environment?
  • Does the F99 environment include individuals with similar training who will serve as role models for the candidate?
  • Given the integrated nature of the training program, will appropriate mentoring and advising be available to the candidate as he/she transitions between the research and clinical components of the integrated training program and to the K00 postdoctoral fellowship position?
  • Is there appropriate institutional commitment to fostering the F99 candidate’s integrated training as a dentist scientist? Does this commitment extend to support the candidate’s research and training, if needed, for the duration of the F99 phase?
  • Is adequate evidence provided that the F99-sponsoring institution is strongly committed to fostering the applicant's development and preparation for transition to the career development phase (K00)?
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 Animal 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 FOA 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.

 

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.

 

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

 

 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.

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:

  • May undergo a committee 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.
  • Will receive a written critique.

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 his or her 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 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 grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. 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 FOA 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, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex. This includes ensuring programs are accessible to persons with limited English proficiency. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html.

HHS recognizes that 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 FOA.

Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.

Transition to the Postdoctoral Career Development Phase (K00)

The F99/K00 award is intended to facilitate the successful transition 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. Applicants are encouraged to apply for postdoctoral positions at departments and institutions different from where they conducted their doctoral research. It is important for all applicants, but especially so for applicants who intend to stay at the predoctoral phase institution for the postdoctoral phase, to provide a plan by which they will separate from their PhD sponsor(s) research program and primary mentorship. The PhD sponsor is encouraged to continue to serve as a resource for career development during the K00 phase but may not be the primary K00 phase mentor.

The postdoctoral research advisor(s) will provide plans to promote the candidate’s research productivity, including publications, along with career development training in areas necessary for an independent research career, such as grant writing and laboratory management. It is strongly encouraged for the mentorship team to include a dentist scientist.

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 dental, oral, and craniofacial 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 awardees 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 facilities and the mentor(s) must have a history of external research awards and sufficient funds to support the proposed postdoctoral research program. Foreign institutions are not eligible. Applicants may apply for postdoctoral positions within the NIH intramural research program (IRP). However, should the individual accept such a position in the IRP as described under eligibility, the postdoctoral phase will be supported directly by NIH intramural funds and the K00 will not be awarded. The individual will be required to submit a final progress report and a final evaluation statement by the primary F99 mentor.

The K00 career development phase institution must submit the 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 will email the application in PDF format to the NIDCR Financial or Grants Management contact person listed on the 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 the awarding component communicating the rationale for the disapproval. This notification typically will be sent within 60 days of receipt of the K00 application.

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

Instructions for the K00 Transition Award

F99 awardees 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 components:

    • A new face page 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 Project Summary and Abstract, Project Narrative, Bibliography & References Cited, Facilities & Other Resources, and Equipment sections;
    • Biographical sketches of the candidate and K00 mentor(s)
    • 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 outside of award effort;
    • An updated 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 transitioning the candidate to the next stage of his/her career by the end of the project award period. The mentor should discuss resources and research support available for the K00 project. The mentor should describe previous experience as a mentor, including type of mentoring (e.g., graduate students, career development awardees, postdoctoral students), number of persons mentored, and career outcomes. If the primary mentor has limited training experience, a co-mentor with a strong, successful track record as a mentor should be included. 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 dental, oral, and craniofacial 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;
    • An updated Description of Institutional Environment;
    • An Institutional Commitment to Candidate’s Research Career Development. If the candidate will engage in part time dental specialty training during the K00 phase, describe the program structure and confirm that the candidate will be able to dedicate the required effort to the K00 research training program. If the candidate is not a U.S. Citizen or permanent resident, the sponsoring institution must include information about the candidate’s visa status and an assurance that the candidate’s visa provides sufficient time to complete the K00 phase of the award at a U.S. institution;
    • Updated Protections for Human Subjects and Inclusion of Women, Minorities, and Individuals Across the Lifespan (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, and
    • 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.

Cooperative Agreement Terms and Conditions of Award

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. Reporting

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually. 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.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All awardees 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 $25,000.  See the NIH Grants Policy Statement for additional information on this reporting requirement. 

Other Fellowship Reporting Requirements:

  • Individuals admitted to the United States as Non-citizens or as Permanent Residents must submit notarized evidence of visa status or legal admission prior to the award.

4. Evaluation

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

 .

Section VII. Agency Contacts

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

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: http://grants.nih.gov/support/ (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: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-945-7573

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov

Scientific/Research Contact(s)

Leslie A. Frieden, Ph.D.
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-496-4263
Email: leslie.frieden@nih.gov

Peer Review Contact(s)

Yasaman Shirazi, PhD
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-594-5593
Email: yasaman.shirazi@nih.gov

Financial/Grants Management Contact(s)

Diana Rutberg, MBA
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-594-4798 
Email: rutbergd@mail.nih.gov

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.

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 45 CFR Part 75.

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 and career development awards are encouraged to apply for an extramural LRP award.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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®


Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files.