National Institutes of Health (NIH)
National Institute of Dental and Craniofacial Research (NIDCR)
Funding Opportunity Title
NIDCR Dentist Scientist Pathway to Independence Award (K99/R00)
Reissue of PAR-09-256
Funding Opportunity Announcement (FOA) Number
Companion Funding Opportunity
Catalog of Federal Domestic Assistance (CFDA) Number(s)
Funding Opportunity Purpose
The primary purpose of the Pathway to Independence Award (K99/R00) program is to increase and maintain a strong cohort of new and talented NIH-supported independent investigators. The program is designed to facilitate a timely transition from a mentored postdoctoral research position to a stable independent research position with independent NIH or other independent research support at an earlier stage than is currently the norm.
This FOA is modeled after the NIH K99/R00 Pathway to Independence Award program and is targeted to recent DDS/PhD graduates. The purpose of the Dentist Scientist K99/R00 award program is to ensure that dual degree dentist scientists receive sufficient mentoring and protected research time necessary to allow them to successfully transition to independent researchers. In order to accomplish this, the mentored K99 phase is generally required to last for the full two year award duration for recent DDS/PhD graduates. The sponsoring institution(s) must guarantee a minimum of 9 person-months (equivalent to 75% full-time professional effort) protected research time during both the K99 and R00 award phases. Award recipients have the option to train in a clinical specialty on a part-time basis during the R00 phase. In this case the R00 phase may be extended for up to five years. Funding from the K99/R00 award cannot be used to support the clinical specialty training. The R00 phase will be limited to 3 years in the event that the awardee already has clinical specialty training, or chooses not to pursue specialty training.
September 11, 2012
Open Date (Earliest Submission Date)
September 12 2012
Letter of Intent Due Date
Application Due Date(s)
Standard dates apply, by 5:00 PM local time of applicant organization.
AIDS Application Due Date(s)
Standard dates apply
Scientific Merit Review
Advisory Council Review
Standard dates apply
Earliest Start Date(s)
Standard dates apply
September 8, 2015
Due Dates for E.O. 12372
Required Application Instructions
It is critical that applicants follow the instructions in the SF 424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application (“K” Series), 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 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
The overall goal of the NIH Research Career Development program is to help ensure that a diverse pool of highly trained scientists is available in appropriate scientific disciplines to address the Nation's biomedical, behavioral, and clinical research needs. More information about Career programs may be found at the NIH Extramural Training Mechanisms website.
The objective of the NIDCR Dentist-Scientist Pathway to Independence Award (K99/R00) initiative is to assist dual degree DDS/DMD-PhD investigators in transitioning to a stable independent research position with NIH or other independent research funding. One of the most challenging transitions in any research career is the transition from postdoctoral trainee to independent scientist. Reports from the National Research Council of the National Academies of Science (Bridges to Independence: Fostering the Independence of New Investigators in Biomedical Research, and Research Training in the Biomedical, Behavioral, and Clinical Research Sciences have highlighted the need for enhanced efforts to foster the transition of postdoctoral scientists from mentored environments to independence. This transition to independence is particularly difficult for dual degree dentist-scientists, whose time for scientific research experiences competes with the demands of their dental and dental specialty training.
NIH believes that the creativity and innovation of new independent investigators in their early career stages play an integral role in addressing our Nation's biomedical, behavioral, and clinical research needs. Dual degree dentist-scientists possess a unique knowledge of oral, dental and craniofacial biology that is critical for accomplishing the NIDCR scientific mission. The intent of the Dentist Scientist K99/R00 program is to assist new dual degree investigators in transitioning to stable independent research positions at an earlier stage in his/her career and with an enhanced probability of success in obtaining independent NIH or other independent research support, and to accommodate the unique needs of the dentist scientist community, including provisions for two years of protected time for mentored postdoctoral training and, under certain circumstances in the independent phase, part-time specialty training.
The NIDCR Dentist-Scientist K99/R00 award will provide up to 7 years of support consisting of two phases. The initial mentored K99 phase is for two full years. During the mentored phase, support will be provided for the most promising DDS/DMD-PhD investigators who have no more than 5 years of postdoctoral research training experience since their most recent degree (whether at the time of the initial application or a subsequent resubmission), and do not already have a full-time tenure track assistant professor position (or equivalent). This initial phase of support will allow the candidate time to obtain additional mentored postdoctoral training, complete research projects, publish results, and attain an independent research position. The candidate must propose a research project that will be pursued during the K99 phase and will transition into an independent project during the R00 phase of the award. The candidate and mentor(s) together will be responsible for all aspects of the mentored (K99 phase) career development and research program. An individual may submit an application from an extramural or intramural sponsoring institution/organization that has a rich and extensive research program in his/her area of interest, as well as the faculty, facilities and resources to support the proposed research endeavor.
Following the mentored phase, the individual may request up to 5 years of support to conduct research as an independent scientist at an extramural sponsoring institution/organization to which the individual has been offered and has accepted a tenure-track full-time assistant professor position (or equivalent). This support is to allow the individual to continue to work toward establishing his/her own independent research program and prepare an application for R01 or equivalent research grant support. Support for the independent phase, however, is not automatic and is contingent upon being accepted by an appropriate extramural institution and the successful NIDCR programmatic review of the individual's mentored phase of the award. Early transitions to the R00 phase may be permitted for individuals who have more than 2 years of postdoctoral research experience since their most recent doctoral degree at the initial K99/R00 application submission deadline. These early transitions will be approved on a case by case basis, and all applicants should propose a 2 year K99 phase in the application. No early R00 phase transitions will be allowed for individuals with less than 2 years of postdoctoral research at the submission deadline.
R00 support beyond three years will be permitted for an awardee who is offered an independent position in a U. S. dental school in conjunction with a dental specialty training program. In such cases, the specialty training program must be structured so that no more than the equivalent of 3 person-months (i.e. 25% effort) in any year is devoted to clinical activities; at least the equivalent of 9 person-months (i.e. 75% effort) each year must comprise protected research time. NIDCR will not provide funding for the clinical specialty training; the dental school hiring the R00 awardee will be expected to support such training. Only specialties recognized by the Council on Dental Education of the American Dental Association will be permitted during the R00 phase. These specialties currently include: Dental Public Health, Endodontics, Oral and Maxillofacial Pathology, Oral and Maxillofacial Radiology, Oral and Maxillofacial Surgery, Orthodontics and Dentofacial Orthopedics, Pediatric Dentistry, Periodontics, and Prosthodontics.
In the initial K99/R00 application, applicants who propose clinical specialty training during the R00 phase must identify which specialty he/she plans to pursue and how certification in that specialty relates to and will enhance the path towards an independent research career. Institutional commitment for clinical specialty training is not necessary in the K99/R00 application. Upon activation of the R00 phase, each awardee will be required to provide institutional assurance that specialty training will be constructed so that clinical activities will occupy no more than the equivalent of 3 person-months (i.e. 25% effort) each year and that the specialty training program will be provided in-kind by the sponsoring institution.
Dual degree dentist scientists who do not intend to pursue specialty training or those who complete the mentored postdoctoral phase and then elect not to participate in specialty training are also eligible and encouraged to apply for this award. In these cases, a three year R00 project period will be awarded.
In addition to this initiative, NIDCR supports a number of other mentored career development programs designed to foster the transition of new investigators to research independence, which may be more suitable for some candidates. For information on other NIDCR-sponsored career development programs please refer to http://www.nidcr.nih.gov/CareersAndTraining.
The OER Glossary and the SF 424 (R&R) Application Guide provide details on these application types.
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. NIDCR anticipates supporting up to 5 dentist-scientist K99/R00 awards per year. There is approximately $7.5 million (total costs) in funding available for the duration of this award program.
Award budgets are composed of salary and other program-related expenses, as described below.
Award Project Period
The mentored K99 phase is generally expected to last for two full years. Candidates who plan for part-time clinical dental specialty training during the R00 phase, may request a 5-year project period for the R00 phase of the award. Candidates who elect not to participate in clinical specialty training should request 3 years of R00 support.
NIH will contribute salary of up to $75,000 per year toward the salary of the career award recipient.
Allowable Costs: Mentored Phase (K99)
Candidates (intramural or extramural) are required to commit a minimum of 9 person-months (equivalent to 75% full-time professional effort) to the pursuit of their career development and research experience during the mentored phase. This experience may also include activities such as completing research publications and searching for an independent research position. Candidates may engage in teaching and/or clinical duties as part of the remaining 25% of the candidate’s full-time professional effort not covered by this award, as long as such duties do not interfere with or detract from the proposed career development program.
Intramural: Mentored candidates in the NIH intramural program will be supported by intramural funds provided by the NIH Institute/Center intramural laboratory in which they are conducting their research. Budget details for the mentored phase will be negotiated with the sponsoring intramural laboratory Institute/Center and salary will be consistent with that offered new scientists in similar positions.
Extramural: NIDCR will contribute up to $75,000 per year toward the salary of the career award recipient. Salary must be consistent with the established salary structure at the institution and with salaries actually provided by the institution fromits own funds to other staff members of equivalent qualifications, rank, and responsibilities in the department concerned. Fringe benefits should be requested based on the sponsoring institution’s rate. NIDCR will contribute up to $25,000 per year towards research expenses. These expenses may include (a) tuition and fees related to career development; (b) supplies, equipment and technical personnel; c) travel to research meetings or training; and (d) statistical services including personnel and computer time.
The extramural sponsoring institution may supplement the NIH salary contribution up to a level that is consistent with the institution's salary scale. However, supplementation may not be from Federal funds unless specifically authorized by the Federal program from which such funds are derived. In no case may additional PHS funds beyond those provided in the K99 award be used for salary supplementation. Under expanded authorities, however, institutions may rebudget funds within the total costs awarded to cover salaries consistent with the institution's salary scale. Institutional supplementation of salary must not require extra duties or responsibilities that would interfere with the purpose of this award.
For information regarding NIH policy on determining full-time professional effort for career awards see NOT-OD-04-056.. If full-time, 12-month salaries are not currently paid to comparable staff members, the salary proposed must be related appropriately to the existing salary structure. Confirmation of salary is required prior to the issuance of an award. Salary for mentors, secretarial and administrative assistance, etc., is not allowed.
Allowable Costs: Independent Phase (R00)
The total cost for the independent investigator phase (R00) may not exceed $249,000 per year. This amount includes salary, fringe benefits, research support allowance and applicable indirect costs. Indirect costs will be reimbursed at the extramural sponsoring institution’s indirect cost rate. Indirect costs requested by consortium participants are included in the total cost limitation.
The salary requested should be based on the person-months effort to be devoted to the R00 project, as is the case for other research grant awards. The candidate is required to devote a minimum of 9 person-months (equivalent to 75% full-time professional effort). See eligibility below. However, it may not be feasible to support this entire effort through the R00 project alone. Recipients of the R00 phase awards may devote effort to other research projects and may reduce effort on the R00 award if they receive additional independent research support. The total salary paid from NIH funds, however, may not exceed the legislatively mandated salary cap. See http://grants.nih.gov/grants/policy/salcap_summary.htm. Please note that a reduction of time devoted to a project by 25% or more from the level in an approved application will require NIH prior approval as described in the NIH Grants Policy Statement.
The total salary requested must be based on a full-time
staff appointment. The 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 of equivalent
qualifications, rank, and responsibilities in the department concerned.
For the extramural K99 phase, Indirect Costs (also known as Facilities & Administrative [F&A] Costs) are reimbursed at 8% of modified total direct costs. For the R00 phase, indirect costs will be reimbursed at the extramural sponsoring institution’s indirect cost rate.
NIH grant policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.
Higher Education Institutions
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
Nonprofits Other Than Institutions of Higher Education
The sponsoring institution may be private (profit or nonprofit) or public, including the NIH Intramural Programs and other Federal laboratories.
The applicant institution will be the mentored phase (K99) institution. All institution/organization types listed above are eligible for both the mentored and independent phase, with one exception: eligible agencies of the Federal government, such as the NIH intramural program, are eligible only for the mentored phase.
Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Applicant organizations must complete the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.
All Program Directors/Principal Investigators (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.
All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least 4-6 weeks prior to the application due date.
Any candidate 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 mentor 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 Principal Investigators are not
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), or for non-U.S. citizen/permanent residents, requirements are described below.
For non-U.S. citizen/permanent residents, the applicant U.S.
institution for each phase of the application (K99 or R00) is responsible for
determining and documenting in the application that the applicant
investigator’s visa will allow him or her to remain in this country long enough
to (a) transition to an independent research career in the U.S. during the
proposed mentored (K99) phase and/or (b) be productive on the research project
in the U.S. for the duration of the proposed independent research (R00) phase.
Individuals are NOT eligible if they:
Eligible PD/PIs are limited to outstanding postdoctoral candidates who have
both a clinical DDS or DMD (or equivalent) degree and a PhD (or equivalent
research doctoral) degree and who have no more than 5 years of postdoctoral
research training since their most recent degree at the time of application submission
or resubmission. It is not required that the degrees were earned together as
part of dual degree (DSTP) training program.
Some institutions appoint postdoctoral fellows in positions with other titles although they are still in non-independent training positions. Candidates in such positions are encouraged to obtain confirmation of their eligibility before they begin to prepare their applications. It is incumbent upon the candidate to provide evidence that the position he/she is in complies with the intent of this eligibility requirement. Evidence for non-independence may include:
Conversely, evidence for independence, and therefore lack of eligibility, includes:
Following clinical training or fellowship training periods,
clinicians often obtain a clinical faculty position that denotes independence
in clinical responsibilities but not in research. A clinical faculty member who
does not hold an independent research faculty position may be eligible for the
K99/R00 award and should contact NIDCR for guidance. Clinicians in such
positions are encouraged to obtain confirmation of their eligibility before
they begin to prepare their applications. Such individuals may also wish to
consider other career awards (e.g., K08, K23) available for junior faculty
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
An individual may not have two or more competing NIH career development applications pending review concurrently. Resubmission applications may be submitted, according to the NIH Policy on Resubmission Applications from the SF 424 (R&R) Application Guide.
Candidates may submit research project grant (RPG) applications concurrently with the K application. However, any concurrent RPG application may not duplicate the provisions of the career award application. K99/R00 award recipients who have transitioned to the R00 phase are encouraged to obtain funding from NIH or other Federal sources either as a PI on a competing research grant award or cooperative agreement, or as project leader on a competing multi-project award as described in NOT-OD-08-065.
At the time of award, the candidate must have a “full-time” appointment at the academic institution that is the applicant institution. Candidates who have VA appointments may not consider part of the VA effort toward satisfying the “full time” requirement at the applicant institution. Candidates with VA appointments should contact the staff person in the relevant Institute or Center prior to preparing an application to discuss their eligibility. Under certain circumstances, an awardee may submit a written request to the awarding component requesting a reduction in minimum required percent effort, which will be considered on a case-by-case basis. Details on this policy are provided in NOT-OD-09-036.
Before submitting the application, the candidate must
identify a mentor who will supervise the proposed career development and
research experience. The mentor should be an active investigator in the area of
the proposed research and be committed both to the career development of the
candidate and to the direct supervision of the candidate’s research. The mentor
must document the availability of sufficient research support and facilities
for high-quality research. The mentor, or a member of the mentoring team,
should have a successful track record of mentoring. Candidates are encouraged
to identify more than one mentor, i.e., a mentoring team, if this is deemed
advantageous for providing expert advice in all aspects of the research career
development program. In such cases, one individual must be identified as the
principal mentor who will coordinate the candidate’s research. The candidate
must work with the mentor(s) in preparing the application.
The mentor should describe the career development plan for the candidate (coordinated with the candidate’s research strategy). The description of the career development plan should include items such as classes, seminars, and opportunities for interaction with other groups and scientists. Training in career skills, e.g., grant-writing and making effective presentations, is strongly encouraged. The mentor and any co-mentors are also expected to provide an assessment of the candidate’s qualifications and potential for a research career. The research environment and the availability and quality of needed research facilities and research resources (e.g., equipment, laboratory space, computer time, available research support, etc.) must also be described.
Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the “Apply for Grant Electronically” button in this FOA or following the directions provided at Grants.gov.
It is critical that applicants follow the 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.
For information on Application Submission and Receipt, visit Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.
The forms package associated with this FOA includes all applicable components, mandatory and optional. Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow the instructions in the SF 424 (R&R) Application Guide to ensure you complete all appropriate “optional” components.
All page limitations described in the SF424 (R&R) Application Guide and the Table of Page Limits must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
Project Summary/Abstract (Component of the Other Project Information Component)
This attachment must be uploaded via the Other Project Information Component, and must include a description of your current research and the research you propose to continue in the independent phase.
Candidates should indicate in the Cover Letter that they are applying for an NIDCR Dentist Scientist Pathway to Independence Award. Candidates should specify the length of their proposed project period in the cover letter.
Additional Instructions for requesting a 7 year budget period: The candidate should prepare the detailed budget for periods 1-5 according to the application instructions. Budget periods 6 and 7 should be specifically requested in Section K. Budget Justification. The candidate should request $249,000 in total costs for each budget period, but an itemized description of costs is not required. The applicant must also explain what dental specialty training is planned for the R00 phase, and justify how certification in that specialty relates to and will enhance the path towards an independent research career.
Please note that for this program, the NIDCR Program Official's preapproval of the additional budget periods is not required.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
Candidate’s Background (Component of Candidate Information)
Career Goals and Objectives (Component of Candidate Information)
Career Development/Training Activities During Award Period (Component of Candidate Information)
Training in the Responsible Conduct of Research (Component of Candidate Information)
Individuals are required to comply with the instructions for Training in the Responsible Conduct of Research as provided in Chapter 7 of the SF424 (R&R) Application Guide.
Statements by Mentor, Co-mentor(s), Consultants, Contributors (Component of Statements of Support)
Description of Institutional Environment (Component of Environment and Institutional Commitment to the Candidate)
Institutional Commitment to the Candidate’s Research Career Development (Component of Environment and Institutional Commitment to the Candidate)
Research Strategy (Component of Research Plan)
Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
Candidates must carefully follow the SF424 (R&R) Application Guide, including the time period for when letters of reference will be accepted (letters are due by the application due date as described in the Notice). 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 Referee Information link and not through Grants.gov.
Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in
advance of the deadline to ensure they have time to make any application
corrections that might be necessary for successful submission.
Organizations must submit applications via 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.
Applicants are responsible for viewing their application 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.
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
Pre-award costs are allowable only as described in the NIH Grants Policy Statement.
Applications must be submitted electronically following the
instructions described in the SF 424 (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 Applying Electronically.
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF 424(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 Central Contractor Registration (CCR). 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 by the Center for Scientific Review, NIH. Applications that are incomplete will not be reviewed.
Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115
Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.
Reviewers should provide their assessment of the likelihood for the candidate to maintain a strong research program, taking into consideration the criteria below in determining the overall impact/priority score.
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.
Does the candidate have the potential for becoming a
successful independent investigator who will contribute significantly to a
chosen health-related research field? Will the research experiences in the
mentored phase prepare the candidate to implement successfully the independent
phase research project? Do the letters of reference from at least three
well-established scientists address the candidate’s potential for becoming an
Career Development Plan/ Career Goals & Objectives/ Plan to Provide Mentoring
To what extent are the plans for evaluating the awardee’s progress adequate and appropriate for guiding the applicant towards a successful transition to the independent phase of the award? Is the timeline planned for the transition to the independent phase of the award appropriate for the candidate’s current stage of scientific and professional development and the career development proposed for the phase of the award?
Is the proposed R00 phase research scientifically
sound and a logical extension of the K99 phase research? Is there evidence of
long-term viability of the proposed R00 phase research plan? To what extent is
the proposed R00 phase research likely to foster the career of the candidate as
an independent investigator in biomedical research?
Mentor(s), Co-Mentor(s), Consultant(s), Collaborator(s)
Are the mentor's research qualifications in the area of the proposed research appropriate? Do(es) the mentor(s) adequately address the candidate’s potential and his/her strengths and areas needing improvement? Is there adequate description of the quality and extent of the mentor’s proposed role in providing guidance and advice to the candidate? Is the mentor’s description of the elements of the research career development activities, including formal course work adequate? Is there evidence of the mentor’s, consultant’s, collaborator’s previous experience in fostering the development of independent investigators? Is there evidence of previous research productivity and peer-reviewed support? Is active/pending support for the proposed research project appropriate and adequate? Are there adequate plans for monitoring and evaluating the career development awardee’s progress toward independence?
Does the mentor have a comprehensive plan to support the proposed K99 phase career development and research plans as well as the candidate’s efforts to transition to independence? Is this plan adequate and appropriate?
Environment & Institutional Commitment to the Candidate
What evidence is provided that the K99 sponsoring institution is strongly committed to fostering the candidate’s development and transition to the independent (R00) phase?
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/priority 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 six 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 six 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 Human Subjects Protection and Inclusion Guidelines.
Inclusion of Women, Minorities, and Children
When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: (1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; (2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; (3) adequacy of veterinary care; (4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and (5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.
Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.
For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.
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/priority score.
Training in the Responsible Conduct of Research
Taking into account the circumstances of the candidate, including level of experience, the reviewers will address the following questions. Does the plan satisfactorily address the format of instruction, e.g., lectures, coursework, and/or real-time discussion groups? Do plans include a sufficiently broad selection of subject matter, such as conflict of interest, authorship, data management, human subjects and animal use, laboratory safety? Do the plans adequately describe the role of the sponsor/mentor or other faculty involvement in the candidate’s instruction? Does the plan meet the minimum requirements for RCR, i.e., eight contact hours of instruction 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.
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 Plans
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) Genome Wide Association Studies (GWAS).
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.
Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), in accordance with NIH peer review policy and procedures, using the stated review criteria. Review assignments will be shown in the eRA Commons.
As part of the scientific peer review, all applications:
Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications . Following initial peer review, recommended applications will receive a second level of review by the National Advisory Council Dental and Craniofacial Research Council.. The following will be considered in making funding decisions:
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
Information regarding the disposition of applications is available in the NIH Grants Policy Statement.
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 the DUNS, CCR Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.
There will not be a formal Notice of Award (NoA) associated with the K99 phase of the award conducted in the NIH intramural program. The awarding Institute will transmit to the successful candidate an approval letter which will include the terms and conditions of the NIH intramural “K99” award, as well as expectations for the transition to the R00 phase of the award.
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. More specifically, for K Awards, visit the Research Career Development (“K”) Awardees section of the NIH Grants Policy Statement.
Transition from the mentored phase to the independent phase
is intended to be continuous in time and, except in unusual circumstances, the
awarding NIH Institute/Center will not extend the K99 phase beyond the 2-year
limit. To activate the independent phase of the grant, individuals must have
been offered and accepted a tenure-track, full-time assistant professor
position (or equivalent) at an eligible institution with appropriate
infrastructure to support the proposed research program and a history of
external research funding. Applicants are free to apply for independent phase
positions within the NIH intramural research program (IRP). However, should the
individual accept such a position in the IRP, the independent phase of the
award will not be activated. This is because NIH intramural scientists are
supported directly by NIH intramural funds and are not eligible for NIH extramural
grant awards. Such outcomes are consistent with the goals of the K99/R00 award
The application for the R00 phase of the award must be submitted no later than 2 months prior to the proposed activation date of the R00 award by the R00 phase grantee organization. However, to avoid potential problems in activation, applicants are strongly encouraged to contact their NIH program official as soon as plans to assume an independent position develop, and not later than 6 months prior to the termination of the K99 phase of the award, to discuss plans for transition to, and the application for, the R00 phase.
The independent phase institution will submit an application on behalf of the candidate for the R00 award using the PHS398 Application.
The R00 application must include:
In addition, a letter from the R00 Department or Division Chairman describing the R00 institution’s commitment to the candidate and plans for his/her career development should be submitted (see below), as well as a final evaluation statement by the K99 phase mentor, if not already provided.
These materials should be sent directly to NIDCR. Details
are available at the NIH New
Investigator Program website. The original application plus one copy
(preferably in a PDF format) are to be mailed to the Financial or Grants
Management contact person of NIDCR listed in the Notice of Grant Award. The R00
application will be evaluated by extramural program staff of the awarding
component for completeness and responsiveness to the program.
An institutional commitment agreement will be required at the time of activation of the independent phase of the award. This agreement should satisfy the criteria described in the Career Development Award Section of the SF424 (R&R) Application Guide.
In addition to space, facilities, resources, and other support needed to conduct the proposed research, the sponsoring institution must provide protected research time (minimum of 9 person-months [75% full-time professional effort]) at least for the duration of the R00 award. The start-up package and other institutional support must be described and should be comparable to that given to other faculty recently hired into tenure-track or equivalent positions. Institutions must provide a startup and salary package equivalent to that provided to a newly hired faculty member who does not have a grant; R00 funds may not be used to offset the typical startup package or to offset the usual institutional commitment to provide salary for tenure-track (or equivalent) assistant professors who are hired without grant support. The R00 sponsoring institution should describe the candidate’s academic appointment, bearing in mind that it must be tenure-track assistant professor (or equivalent), and confirm that the appointment is not contingent on the transfer of the award to the institution. The R00 phase institution must foster and support the awardee’s ability to apply for and secure independent research grant (R01) support. If the candidate will engage in clinical specialty training during the R00 phase, the sponsoring institution must provide a description of the specialty training program and institutional assurance that clinical specialty training will occupy no more than 3 person-months (25% professional effort). The sponsoring institution must verify that tuiton costs will be provided in-kind.
The R00 award requires that a minimum of 9 person-months (75% full time professional effort) be devoted to research activities. Consequently, teaching, clinical duties and other non-research activities should be minimal during the R00 award period. NIH staff may review start-up packages and other commitments between the institution and candidate prior to activating the independent phase of the award. It is suggested that the applicant and/or the hiring institution discuss the institutional commitment with the relevant NIH institute program official prior to submission of the R00 application. NIH will not activate the independent phase if the institutional commitment is deemed inadequate. Applicants who are approved to transition will receive a Notice of Award for the R00, the dollar amount, and the new recipient organization (if applicable).
The K99/R00 award is intended to facilitate successful transition to independence. Consequently, a requirement for activation of the R00 phase is successful completion of this transition. Applicants are encouraged (but not required) to apply for independent positions at departments and institutions different from where they conducted their mentored research. It is important for all applicants, but especially so for applicants who intend to stay at the mentored phase institution for the independent phase, to provide a plan by which they will separate from their mentor and advance to independence. Awardees are also encouraged to include a plan and timeline for submitting an independent research grant application in a research area relevant to the mission of an NIH awarding component.
Candidates who are not approved to transition will receive written notification from the awarding component communicating the rationale for the disapproval. This letter typically will be sent within 60 days of receipt of the R00 application.
Although the financial plans of the NIH Institute or Center provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds.
If transition from the K99 phase at an extramural institution to the R00 phase occurs at the originally scheduled end date of the K99 award, then no specific steps to terminate the K99 award are necessary. If the transition occurs prior to the scheduled end date, then a revised Notice of Award will be issued to terminate the K99 phase award. Carry-over of unspent funds from a partially completed year in the K99 phase into the R00 phase may be permitted.
When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement. The Additional Instructions for Preparing Continuation Career Development Award (CDA) Progress Reports, must be followed. The Mentor’s Report must include an annual evaluation statement of the candidate’s progress.
A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.
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.
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.
We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.
GrantsInfo (Questions regarding application instructions and
process, finding NIH grant resources)
eRA Commons Help Desk (Questions regarding eRA Commons
registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
Leslie A. Frieden, PhD
National Institute of Dental and Craniofacial Research (NIDCR)
Yasaman Shirazi, PhD
Chief, Scientific Review Branch
National Institue of Dental and Craniofacial Research (NIDCR)
Dede Rutberg, MBA
Grants Management Branch
National Institue of Dental and Craniofacial Research (NIDCR)
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 Part 52 and 45 CFR Parts 74 and 92.
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