Part 1. Overview Information

Key Dates

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.

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

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

Background

The NIH Advisory Committee to the Director Working Group on Diversity in the Biomedical Research Workforce identified key transition points at which nationally underrepresented groups leave the research workforce pipeline. One critical juncture is the predoctoral to postdoctoral transition. It has been reported that many individuals from underrepresented minorities progressively lose interest in research intensive careers during graduate training (Gibbs et al., 2014). Strong mentorship, especially through structured, formalized programs, can promote increased science self-efficacy and strengthen an individual’s commitment to a research career (Chemers et al, 2011; Davis et al., 2005; Pfund et al., 2016). Mentorship can be particularly crucial for enabling individuals from underrepresented groups to navigate a research career pathway (Chemers et. al. 2011; Pfund et al., 2016).

The NIDCR F99/K00 award is intended to provide individualized mentorship over the transition from predoctoral student to postdoctoral researcher through two continuous support phases. The first phase (F99) will provide support for up to 2 years of research training for individuals in PhD or dual degree clinician scientist programs. During this phase, students are expected to complete their doctoral degree(s), 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 support for up to 3 years of mentored postdoctoral research and career development. F99/K00 applicants are not required to identify postdoctoral research mentors at the time of application, and F99 awardees are encouraged to apply for postdoctoral positions at departments and institutions different from where they conducted their graduate research. K00 awards will be made only to PD/PIs who have successfully completed doctoral degree requirements and their F99 research training programs, attained postdoctoral positions, and, in collaboration with the K00 mentorship team, provided NIDCR with strong research training and career development plans that will facilitate independent research careers dedicated to improving dental, oral and craniofacial health.

The expected outcome of the F99/K00 program is enhanced participation of individuals from diverse backgrounds, in the NIDCR research workforce who can bring their unique experiences, perspectives and innovation to addressing dental, oral and craniofacial disease. Other desired program outcomes include completion of doctoral degree programs, transition to dental, oral and craniofacial postdoctoral research positions, and achievement of subsequent research funding, such as NIDCR individual career development awards and research project grants.

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

Other Award Budget Information

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

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

Section III. Eligibility Information

1. Eligible Applicants

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Governments

• None

• None

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

K00 Eligibility: All domestic institution/organization types listed above are eligible to submit K00 transition phase applications on behalf of F99 awardees. Note that if the 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.

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.

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.
  • NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
• 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.

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.

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

Fostering diversity in the scientific research workforce is a key component of the NIH strategy to identify, develop, support and maintain the quality of our scientific human capital (NOT-OD-20-031).

Every facet of the United States scientific research enterprise from basic laboratory research to clinical and translational research to policy formation requires superior intellect, creativity, and a wide range of skill sets and viewpoints. NIH's ability to help ensure that the nation remains a global leader in scientific discovery and innovation is dependent upon a pool of highly talented scientists from diverse backgrounds, including those from underrepresented groups, who will help to further NIH's mission.

Research shows that diverse teams working together and capitalizing on innovative ideas and distinct perspectives outperform homogenous teams. Scientists and trainees from diverse backgrounds and life experiences bring different perspectives, creativity, and individual enterprise to address complex scientific problems. There are many benefits that flow from a diverse NIH-supported scientific workforce, including: fostering scientific innovation, enhancing global competitiveness, contributing to robust learning environments, improving the quality of the research, advancing the likelihood that underserved or health disparity populations participate in, and benefit from health research, and enhancing public trust. In spite of tremendous advancements in scientific research, information, educational and research opportunities are not equally available to all.

For the purpose of this announcement, institutions are encouraged to recruit potential student participants from diverse backgrounds, such as:

A. Individuals from racial and ethnic groups that have been shown by the National Science Foundation to be underrepresented in health-related sciences on a national basis (see data at http://www.nsf.gov/statistics/showpub.cfm?TopID=2&SubID=27) and the report (Women, Minorities, and Persons with Disabilities in Science and Engineering). The following racial and ethnic groups have been shown to be underrepresented in biomedical research: Blacks or African Americans, Hispanics or Latinos, American Indians or Alaska Natives, Native Hawaiians and other Pacific Islanders. In addition, it is recognized that underrepresentation can vary from setting to setting; individuals from racial or ethnic groups that can be demonstrated convincingly to be underrepresented by the grantee institution should be encouraged to participate in this program. For more information on racial and ethnic categories and definitions, see the OMB Revisions to the Standards for Classification of Federal Data on Race and Ethnicity (https://www.govinfo.gov/content/pkg/FR-1997-10-30/html/97-28653.htm)..

B. Individuals with disabilities, who are defined as those with a physical or mental impairment that substantially limits one or more major life activities, as described in the Americans with Disabilities Act of 1990, as amended. See NSF data at https://www.nsf.gov/statistics/2017/nsf17310/static/data/ tab7-5.pdf.

C. Individuals from disadvantaged backgrounds, defined as those who meet two or more of the following criteria:

1. Were or currently are homeless, as defined by the McKinney-Vento Homeless Assistance Act (Definition: https://nche.ed.gov/mckinney-vento/);

2. Were or currently are in the foster care system, as defined by the Administration for Children and Families (Definition: https://www.acf.hhs.gov/cb/focus-areas/foster-care);

3. Were eligible for the Federal Free and Reduced Lunch Program for two or more years (Definition: https://www.fns.usda.gov/school-meals/income-eligibility-guidelines);

4. Have/had no parents or legal guardians who completed a bachelor’s degree (see https://nces.ed.gov/pubs2018/2018009.pdf);

5. Were or currently are eligible for Federal Pell grants (Definition: https://www2.ed.gov/programs/fpg/eligibility.html);

6. Received support from the Special Supplemental Nutrition Program for Women, Infants and Children (WIC) as a parent or child (Definition: https://www.fns.usda.gov/wic/wic-eligibility-requirements).

7. Grew up in one of the following areas: a) a U.S. rural area, as designated by the Health Resources and Services Administration (HRSA) Rural Health Grants Eligibility Analyzer (https://data.hrsa.gov/tools/rural-health), or b) a Centers for Medicare and Medicaid Services-designated Low-Income and Health Professional Shortage Areas (qualifying zipcodes are included in the file). Only one of the two possibilities in #7 can be used as a criterion for the disadvantaged background definition.

Students from low socioeconomic (SES) status backgrounds have been shown to obtain bachelor’s and advanced degrees at significantly lower rates than students from middle and high SES groups (see https://nces.ed.gov/programs/coe/indicator_tva.asp), and are subsequently less likely to be represented in biomedical research. For background see Department of Education data at, https://nces.ed.gov/; https://nces.ed.gov/programs/coe/indicator_tva.asp; https://www2.ed.gov/rschstat/research/pubs/advancing-diversity-inclusion.pdf.

D. Literature shows that women from the above backgrounds (categories A, B, and C) face particular challenges at the graduate level and beyond in scientific fields. (See, e.g., From the NIH: A Systems Approach to Increasing the Diversity of Biomedical Research Workforce https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5008902/ ).

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

Individuals who are currently being supported under F30 or F31 are eligible to apply for this program; however, they must give up the F30 or F31 if they decide 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 program eligibility requirements.

The applicant must be currently enrolled in a PhD or equivalent research degree program (e.g., EngD, DNSc, DrPH, DSW, PharmD, ScD), a formally combined DDS/DMD-PhD program, or other combined professional/clinical and research doctoral program (e.g., MD-PhD) in the biomedical, behavioral, or clinical sciences at a domestic institution. At the time of award, the applicant is expected to require no more than 2 years to complete their PhD or dual-degree training (F99 phase) before transitioning to mentored postdoctoral research training (K00 phase). Applicants conducting dissertation research in dental, oral, craniofacial or related research fields are encouraged to apply. Potential candidates are strongly encouraged to discuss their eligibility with the NIDCR Scientific Program contact in advance of application.

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.

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).

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

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.

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, 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.

Before submitting the application, the applicant must identify an F99 sponsor(s) who will supervise the proposed mentored training experience. Applicants conducting F99 research in fields outside of dental, oral and craniofacial research or planning to switch to a new dental, oral and craniofacial research area in the K00 phase are expected to include an F99 co-sponsor or consultant with relevant dental, oral, and craniofacial research expertise and a strong mentorship record. Applicants are encouraged to identify more than one sponsor, i.e., a sponsor team of sponsors, if this is deemed advantageous for their training program. When there is a sponsor team, one individual must be identified as the primary sponsor, and will be expected to coordinate the applicant’s overall F99 training. The applicant must work with the sponsor(s) in preparing the application.

Applicants are not required to identify a sponsor for the K00 phase at 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 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.

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.

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

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

Other Project Information

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

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

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

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

Doctoral Dissertation and Research Experience

Include a description of how the combination of past research experiences, or research and clinical experiences for dual degree predoctoral students, and the F99/K00 plans contribute to achieving the long-term career goal of becoming an independent dental, oral and craniofacial research investigator.

Training Goals and Objectives

Describe short-term and long-term dental, oral and craniofacial research career goals and explain how the F99/K00 will enable the attainment of these goals.

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.

Discuss the longer-term goals for research and career development 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 each phase and explain how the activities will facilitate the transition to each subsequent career stage and ultimately, establishment of an independent dental, oral and craniofacial research career. Include a timeline with scientific, professional development, and career milestones. 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 dental, oral, and craniofacial research area of focus and K00 institution. Describe the desirable mentor qualifications and attributes as well as the institutional environment needed to facilitate the K00 phase research.

Dual Degree Students: The applicant’s research and clinical training plan, i.e., the activities planned under this award, should be individually tailored and well integrated with his/her research project. Describe the skills and techniques that the applicant intends to learn, as well as any planned, non-research activities (e.g., those relating to professional development and clinical activities) during the award period. The applicant should discuss progress in the research and clinical training programs thus far and provide a timeline for the remaining duration of the dual-degree program in which he/she is matriculated. On the timeline, indicate the estimated percentage of time that will be devoted to clinical- and research-related activities during each F99 year.

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.
• Describe the strengths and weaknesses in the rigor of the prior research (both published and unpublished) that serves as the key support for the proposed project.
• Explain how the proposed project will improve scientific knowledge, technical capability, and/or clinical practice in one or more broad fields.
• Describe how the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field will be changed if the proposed aims are achieved.

Describe how the proposed F99 research and, if applicable. clinical training is related to the candidate's next steps for the K00 career development phase.

Approach

Describe the dissertation research, including the background, goal, rationale, and hypotheses of the research project(s). The Approach for this Aim should be organized into two sections:

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, and craniofacial research.

Approach

Provide a general 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 is associated with research redirection, can establish a foundation for a dental, oral, and craniofacial focused research career. Identify technical and career development skills that will be achieved during the K00 training. Describe the mentorship expertise and institutional environment that could support these studies.

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

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

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

• 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 research and career development progress will be monitored and evaluated throughout the F99 phase.
• If the anticipated 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.
• The sponsor and any co-sponsor(s) for the F99 should discuss the applicant's qualifications and potential for transitioning to the K00 postdoctoral phase and for pursuing a long term career in dental, oral and craniofacial research.
• 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 though fellows can take part in all components of a clinical trial. Oversight includes (but is not limited to): interacting with relevant Institutional Review Board (IRB) staff; reviewing all informed consent documents; reporting potential serious adverse events; and maintaining responsibility for patient safety. However, the fellow can gain experience in all these components in conjunction with the mentor or individual leading the trial.

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

• Confirm that applicant is on track to complete all degree program requirements, either graduate PhD or dual degree programs, within two years of the F99 award start date.

Description of Candidate’s Contribution to Program Goals

The sponsoring institution must provide a document on institutional letterhead that explains how the candidate’s participation will further the goals of the fellowship. See the Notice of NIH's Interest in Diversity.

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

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

Appendix

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

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. If gaining research experience in a clinical trial led by a sponsor/co-sponsor, provide the sponsor’s ClinicalTrials.gov identifier (i.e., NCT number).

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.

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.

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

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.

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.

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.

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:

• An F99/K00 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.

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

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

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

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by NIDCR, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

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

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

3. Anticipated Announcement and Award Dates

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.

Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, 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.

• Recipients of FFA must ensure that their programs are accessible to persons with limited English proficiency. HHS provides guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.html and https://www.lep.gov. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at https://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

• Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html.

• HHS funded health and education programs must be administered in an environment free of sexual harassment. Please see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html; https://www2.ed.gov/about/offices/list/ocr/docs/shguide.html; and https://www.eeoc.gov/eeoc/publications/upload/fs-sex.pdf. For information about NIH's commitment to supporting a safe and respectful work environment, who to contact with questions or concerns, and what NIH's expectations are for institutions and the individuals supported on NIH-funded awards, please see https://grants.nih.gov/grants/policy/harassment.htm.

• Recipients of FFA must also administer their programs in compliance with applicable federal religious nondiscrimination laws and applicable federal conscience protection and associated anti-discrimination laws. Collectively, these laws prohibit exclusion, adverse treatment, coercion, or other discrimination against persons or entities on the basis of their consciences, religious beliefs, or moral convictions. Please see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/index.html.

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 PhD or 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). 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 achievements, including publications, along with career development training in areas necessary for an independent research career, such as grant writing and laboratory management.

The transition from the predoctoral phase to the postdoctoral phase is intended to be continuous in time and, except in unusual circumstances, NIDCR will not extend the F99 phase. To begin the K00 award phase of the grant, individuals must have been offered and accepted a postdoctoral appointment to carry out dental, oral, and craniofacial research. Upon starting the K00 phase of the award, the F99 phase of the award is ended. 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 infrastructure and the mentor(s) must have sufficient funds and a history of external research awards 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, 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 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 for candidate and K00 sponsor(s)
  • Detailed budget pages for a non-modular budget: K00 budgets consist of salary and fringe benefits, tuition and fees, 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;
  • 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. For candidates transitioning to dental, oral, and craniofacial 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 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;
  • 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, 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.

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

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

3. 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 Permanent Residents must submit notarized evidence of 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.

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

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

F99

• Successful completion of graduate programs
• Achievement of dental, oral and craniofacial postdoctoral research positions
• Research products, such as scientific publications

K00:

• Research products, such as scientific publications
• Achievement of independent research faculty positions
• Subsequent independent career development or research grant support from NIH and/or other sources

Section VII. Agency Contacts

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

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

Finding Help Online: 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: 301-637-3015

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

Anissa J. Brown, PhD
Research Training and Career Development Branch
National Institute of Dental and Craniofacial Research
Telephone: (301) 594-4805
Email: anissa.brown@nih.gov

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

Diana Rutberg, M.B.A.
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.

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.