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 Predoctoral to Postdoctoral Transition Award for a Diverse Dental, Oral and Craniofacial Research Workforce (F99/K00 Independent Clinical Trial Not Allowed)

Activity Code

F99/K00 Individual Predoctoral to Postdoctoral Transition Award

Announcement Type

New

Related Notices
  • March 10, 2020 - Reminder: FORMS-F Grant Application Forms & Instructions Must be Used for Due Dates On or After May 25, 2020- New Grant Application Instructions Now Available. See Notice NOT-OD-20-077.
  • January 22, 2020 - Additional Guidance on the NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research. See Notice NOT-OD-20-058.
  • January 17, 2020 - Notice of Correction to NIDCR Predoctoral to Postdoctoral Transition Award for a Diverse Dental, Oral and Craniofacial Research Workforce (F99/K00 Independent Clinical Trial Not Allowed) PAR-20-069. See Notice NOT-DE-20-007.
  • July 22, 2019 - Requirement for ORCID iDs for Individuals Supported by Research Training, Fellowship, Research Education, and Career Development Awards Beginning in FY 2020. See Notice NOT-OD-19-109
Funding Opportunity Announcement (FOA) Number

PAR-20-069

Companion Funding Opportunity

None

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.121

Funding Opportunity Purpose

The purpose of the NIDCR Predoctoral to Postdoctoral Transition Award for a Diverse Dental, Oral and Craniofacial Research Workforce (F99/K00) is to support outstanding graduate students from diverse backgrounds, including those from groups underrepresented in biomedical, clinical, behavioral and social sciences, over the transition from predoctoral to postdoctoral research training.. This phased award program will facilitate completion of graduate PhD or dual degree clinician scientist programs (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 enable achievement of an independent research faculty position and subsequent NIDCR career development and research project awards.

This Funding Opportunity Announcement (FOA) does not allow prospective fellows to propose to lead an independent clinical trial, but does allow prospective fellows to propose research experience in a clinical trial led by a sponsor or co-sponsor.

Key Dates
Posted Date

December 9, 2019

Open Date (Earliest Submission Date)

March 8, 2020

Letter of Intent Due Date(s)

Not Applicable

Application Due Date(s)

Standard dates apply

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, 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 these dates.

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

Not Applicable for Fellowships

Earliest Start Date
Expiration Date

January 8, 2023

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 1. Overview Information
    Part 2. Full Text of the Announcement
    Section I. Funding Opportunity Description
    Section II. Award Information
    Section III. Eligibility Information
    Section IV. Application and Submission Information
    Section V. Application Review Information
    Section VI. Award Administration Information
    Section VII. Agency Contacts
    Section VIII. Other Information


    Part 2. Full Text of Announcement
    Section I. Funding Opportunity Description

    NIH's Diversity Statement

    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 (DOC) research. NIDCR encourages multidisciplinary and interdisciplinary research training and career development to prepare a workforce that can address complex oral health problems in a highly diverse U.S. population and can contribute to the realization of NIDCR research priorities and the NIDCR Strategic Plan. The NIDCR is committed to promoting the diversity of the DOC 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 support 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 up to 3 years of mentored postdoctoral research career development support. 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. The K00 award will be made only to a PD/PI who has successfully completed doctoral degree requirements and the F99 research training program, attained a postdoctoral research position in DOC research, and, in collaboration with the K00 mentorship team, provided NIDCR with a strong DOC research training and career development plan that will ultimately facilitate an independent DOC research career.

    The expected outcome of the F99/K00 program is enhanced participation of individuals from diverse backgrounds, including those from groups underrepresented in the DOC research workforce. Other desired program outcomes include completion of doctoral degree programs, transition to DOC postdoctoral research positions, and achievement of subsequent DOC research funding, such as NIDCR individual career development awards and research project grants.

    Note: This Funding Opportunity Announcement (FOA) does not allow prospective fellows to propose to lead an independent clinical trial, but does allow prospective fellows to proposeresearch 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

    New
    Resubmission

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

    Need help determining whether you are doing a clinical trial?

    Funds Available and Anticipated Number of Awards

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

    Award Budget

    For the F99 phase, award budgets are composed of stipends, tuition and fees, and institutional allowance, as described below.

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

    Award Project Period

    For the F99/K00 award, individuals may receive up to 5 years combined support for both phases, which includes 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 and F31 levels allowable under the Ruth L. Kirschstein National Research Service Award (NRSA),

    ALLOWABLE COSTS: 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.

    The total salary, however, may not exceed the legislatively mandated salary cap. See:http://grants.nih.gov/grants/policy/salcap_summary.htm.

    Tuition and Fees

    ALLOWABLE COSTS: 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 PhD and dual degreee 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 and F31 Ruth L. Kirschstein National Research Service Award (NRSA) awards. See: https://researchtraining.nih.gov/resources/policy-notices.

    ALLOWABLE COSTS: K00 PHASE

    The NIDCR will provide up to $10,000 per year towards the research development support for the award recipient, which must be justified and consistent with the stage of development of the candidate and the proportion of time to be spent in research or career development activities. These costs may be used for the following expenses: (a) tuition and fees related to career development; (b) research expenses, such as supplies, equipment and technical personnel; c) travel to research meetings or training; and (d) statistical services including personnel and computer time.

    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)

    Other

    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.

    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.
    • 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.

    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.

    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)..

    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 underrepresented groups, 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.asphttps://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, the applicant must forfeit both the F99 and the K00 awards.

    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.  

    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 both DOC and 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 F99/K00 awards are encouraged to consider an extramural LRP award in their future plans.

    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 instititution) 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.

    Sponsor

    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 DOC research or planning to switch to a new DOC research area in the K00 phase should include an F99 co-sponsor or consultant with relevant DOC research expertise and a strong mentorship record. Applicants 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 applicant’s overall F99 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 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).

    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 (R&R) 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.

    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, with the following additional instructions:

    Other Attachments:  

    Institutional Letter

    Applications must include a letter from the F99 institution explaining how the candidate’s participation will further the goals of the F99/K00 program to promote diversity in health-related research, consistent with the Notice of NIH’s Interest in Diversity (NOT-OD-20-031). The letter from the institution must be on institutional letterhead and scanned so that an institutional official signature is visible. Name the PDF-formatted letter "NIDCR Institutional_Ltr.pdf."

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

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

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

    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, with the following additional instructions:

    Fellowship Applicant Section

    Applicant’s Background and Goals for Fellowship Training

    This section should address both the F99 phase and the K00 phase.

    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 DOC research investigator.

    Dual Degree Students: Discuss how the proposed integrated F99 research and clinical training plan will enhance knowledge and technical, clinical and professional skills, and facilitate transition to the K00 career development phase. 

    Training Goals and Objectives

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

    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 skills. If the K00 DOC 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 postdoctorate.  

    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 DOC 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 DOC research area of focus and K00 phase 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:

    Specific Aims

    All applicants must use these two Specific Aims:

    Specific Aim 1: The F99 Research Project.

    • Provide a detailed description of the research to be completed in the F99 phase.

    Specific Aim 2: The Postdoctoral Research Direction.

    Identify the DOC research direction to be pursued for the K00 phase.  For more information about DOC research programs, see NIDCR grant programs and the NIDCR Strategic Plan.

    Research Strategy

    Specific Aim 1 (F99):

    Significance

    PhD graduate students: Provide an overview of the PhD dissertation research being addressed and its potential impact on the research field. Describe how the proposed F99 research training is related to the candidate's next steps for the K00 career development phase.

    Dual degree clinician-PhD students: Provide an overview of the PhD dissertation research being addressed and the potential impact on the research field. Describe how the proposed F99 clinical and research 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.

    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 DOC 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 results, potential challenges and alternative strategies. Explain how prior training, especially if the K00 is associated with research redirection, can establish a foundation for a DOC-focused research career. Discuss how the K00 research training and career develoment 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 prospective fellow 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 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 DOC 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  prospective fellow 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 prospective fellow  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 trainees and 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 trainee or 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

    Description of Institutional Environment and Commitment to Training

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

    • 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. 

    Appendix

    Limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.  

    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 a 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, with the following additional instructions:

    • 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. The National Research Service Award (NRSA) policies apply to this program.  A Kirschstein-NRSA fellowship may not be held concurrently with another federally sponsored fellowship or similar Federal award that provides a stipend or otherwise duplicates provisions of this award.

    Pre-award costs are generally not allowable for F99 awards.

    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) and sponsor(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. In addition, the review will evaluate the plans for the K00 phase, emphasizing the need for the proposed training and the potential to lead to a productive, independent DOC research career.
    Overall Impact/Merit

    Reviewers will provide an overall impact score to reflect their assessment of the likelihood that the fellowship will enhance the applicant’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.

    Fellowship Applicant

    • Are the applicant’s academic record and research experience of high quality?
    • Does the applicant have the potential to develop into an independent and productive dental, oral and craniofacial researcher?
    • Does the applicant demonstrate commitment to a research career in dental, oral and craniofacial research in the future?
    • Do the letters of reference provide evidence that the applicant has both a strong commitment to and high potential for becoming an independent research investigator?
    • Does the applicant demonstrate potential for sucessful transition to a strong postdoctoral position in dental, oral and craniofacial research (K00 phase)? 

    Sponsors, Collaborators, and Consultants

    • 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 applicant?
    • Is there evidence of a match between the research and clinical interests (if applicable) of the applicant and the sponsor(s)? Do(es) the sponsor(s) demonstrate an understanding of the applicant’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 applicant’s proposed research project and training for the duration of the F99 phase?
    • 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?
    • Have the sponsor(s) provided a strong mentorship plan with provisions for monitoring and evaluating the applicant's F99 research and career development progress?
    • 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?
    • If the research direction for the K00 phase is outside of the primary sponsor's expertise, have adequate plans been presented to provide the applicant with a foundation for the K00 postdoctorate?
    • If the prospective fellow 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?

    Research Training Plan

    • Is the proposed F99 research project of high scientific quality, and is it well integrated with the proposed research training plan?
    • Based on the sponsor’s description of his/her active research program, is the applicant’s proposed F99 research project sufficiently distinct from the sponsor’s funded research for the applicant’s career stage?
    • Is the F99 research project consistent with the applicant’s stage of research development?
    • Is the proposed time frame feasible to accomplish the proposed research training program (F99) and transition to the career development phase (K00)?
    • Have the applicant and/or sponsor(s) outlined targets for research progress to promote transition from the fellowship phase (F99) to the career development phase (K00)?
    • Is the research direction of the career development phase (K00) appropriate to the applicant's anticipated stage of development and likely to promote the candidate's independent dental, oral and craniofacial research career?
    • If proposed, will the clinical trial experience contribute to the proposed project and/or the prospective fellow’s research training?

    Training Potential

    • Are the proposed research project and training plan likely to provide the applicant 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 applicant’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 applicant’s ability to develop into a productive researcher?
    • 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 applicant and sponsor(s) provided a strong plan for identifying career development phase (K00) mentors(s) with appropriate expertise and qualifications?
    • Have the applicant 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?

    Institutional Environment & Commitment to Training

    • Are the research facilities, resources (e.g., equipment, laboratory space, computer time, subject populations), and training opportunities (e.g. seminars, workshops, professional development opportunities) adequate and appropriate?
    • Is the institutional environment for the applicant’s scientific development of high quality?
    • 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.

    Protections for Human Subjects

    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.

    Inclusion of Women, Minorities, and Individuals Across the Lifespan 

    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.

    Vertebrate Animals

    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.

    Biohazards

    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.

    Resubmissions

    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.

    Renewals

    Not Allowed

    Revisions

    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.

    Training in the Responsible Conduct of Research

    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 applicant, including any prior instruction or participation in RCR as appropriate for the applicant’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.

    Applications from Foreign Organizations

    Not Applicable.

    Select Agent Research

    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).

    Resource Sharing

    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.

    Budget and Period of Support

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

    2. Review and Selection Process

    Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), convened by NIDCR in accordance with NIH peer review 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 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.

    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 law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency.  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. HHS provides general 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/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-individuals/section-1557/index.html; and https://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see https://www.hhs.gov/civil-rights/for-individuals/disability/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. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. 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 http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

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

    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 DOC 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 DOC 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 from non-DOC to DOC research, discuss plans to provide a strong foundation in research design, methods and analytic techniques for the DOC research area, and the relationship of the research training to DOC health and disease. If the candidate is proposing to gain experience in a clinical trial as part of his or her research training, the mentor or co-mentor must include a statement to document leadership of the clinical trial including source of funding, NCT# and appropriate expertise to guide the candidate in any proposed clinical trials research experience;
    • An updated Description of Institutional Environment;
    • An Institutional Commitment to Candidate’s Research Career Development;
    • Updated Protections for Human Subjects and Inclusion of Women, Minorities and Children (as appropriate);
    • Updated Other Research Plan Sections (as appropriate), including:
      • vertebrate Animals;
      • Select Agent Research;
      • Resource Sharing Plans; and
      • Authentication of Key Biological and/or Chemical Resources
      • Updated Biohazards (as appropriate).
    • 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.

    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 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 NIDCR 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 DOC 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 applicants.

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

    Financial/Grants Management Contact(s)

    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.

    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 Part 52 and 45 CFR Part 75.

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