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 Dentist Scientist Pathway to Independence Award (K99/R00)

Activity Code

K99/R00 Career Transition Award/Research Transition Award

Announcement Type

Reissue of PAR-12-283

Related Notices
  • June 4, 2014 - Notice NOT-14-074 supersedes instructions in Section III.3 regarding applications that are essentially the same.
Funding Opportunity Announcement (FOA) Number

PAR-14-057

Companion Funding Opportunity

None

Number of Applications

See Section III. 3. Additional Information on Eligibility.

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

93.121

Funding Opportunity Purpose

The purpose of the NIDCR Dentist Scientist Pathway to Independence Award (K99/R00) program is to increase and maintain a strong cohort of new and talented independent dual degree dentist scientists and to provide NIDCR research support that will help these individuals launch competitive, independent research careers.  This program is designed to facilitate a timely transition of outstanding dual degree dentist scientists from mentored, postdoctoral research positions to independent, tenure-track or equivalent faculty positions by providing support for two years of mentored training and three to five years of independent research.  The option for five years of independent (R00) support is available to accommodate clinical specialty training at no more than 25% effort. 

Key Dates
Posted Date

January 2, 2014

Open Date (Earliest Submission Date)

January 12, 2014

Letter of Intent Due Date(s)

Not Applicable

Application Due Date(s)

Standard dates apply, with the first due date for this FOA being February 12, 2014

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, with the first AIDS due date for this FOA being May 7, 2014

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

Standard dates

Advisory Council Review

Standard dates apply

Earliest Start Date

Standard dates apply

Expiration Date

January 8, 2017

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (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.


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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

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.  In addition to this opportunity, NIH Institutes and Centers (ICs) support a variety of other mentored career development programs designed to foster the transition of new investigators to research independence. These other programs may be more suitable for particular candidates.  NIH also supports non-mentored career development programs for independent investigators. More information about Career programs may be found at the NIH Extramural Training Mechanisms website.

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.  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 may be limited by their clinical responsibilities and further clinical specialty training.

Dual degree dentist-scientists possess a unique knowledge of oral, dental and craniofacial biology that is critical for accomplishing the NIDCR scientific mission. The objective of the NIDCR Dentist-Scientist Pathway to Independence Award (K99/R00) is to help outstanding dual degree DDS/DMD-PhD investigators complete needed, mentored training and transition in a timely manner to independent, tenure-track or equivalent faculty positions. The K99/R00 award is intended to foster the development of a creative, independent research program that will be competitive for subsequent independent funding and that will help advance the mission of the NIDCR.  This program is also designed to meet the specific needs of the dentist scientist career path, including provisions for two years of protected time for mentored postdoctoral training and, under certain circumstances in the independent phase, part-time specialty training.

Nature of the Career/Research Transition Opportunity

Applicants must have no more than 4 years of postdoctoral research experience since their most recent doctoral degree at the time of the initial or the subsequent resubmission or revision application. The strongest applicants will require, and will propose, a well-conceived plan for 2 years of substantive mentored research training and career development that will help them become competitive candidates for tenure-track faculty positions and prepare them to launch robust, independent research programs. An individual who cannot provide a compelling rationale for additional mentored research training at the time of award is not a strong candidate for this award.

Individuals must be in mentored, postdoctoral training positions to be eligible to apply to the K99/R00 program. If an applicant achieves independence (any faculty or non-mentored research position) before a K99 award is made, neither the K99, nor the R00 award, will be made.

The NIDCR Dentist-Scientist K99/R00 award will provide up to 7 years of support in two phases. The initial (K99) phase will provide support for two full years of mentored postdoctoral research training and career development. The second (R00) phase will provide up to 5 years of independent research support, which is contingent on satisfactory progress during the K99 phase and an approved, independent, tenure-track (or equivalent) faculty position. The two award phases are intended to be continuous in time. Therefore, although exceptions may be possible in limited circumstances, R00 awards will generally only be made to those K99 PDs/PIs who accept independent, tenure-track (or equivalent) faculty positions by the end of the K99 award period.

K99 Phase: The initial K99 phase will support the candidate while he/she obtains additional mentored training and career development, completes research, publishes results, and searches for an independent faculty position. The candidate must propose a research project that will be pursued during the K99 phase and be carried forward into an independent project during the R00 phase of the award. The candidate must also propose a career development plan of activities that will help prepare the individual for his/her career as an independent researcher.  The candidate and mentor(s) together should be involved in developing all aspects of the mentored (K99) career development and research programs. However, a significant component of the proposed K99/R00 research project must be distinct from projects to be continued in the mentor’s laboratory after the K99 PD/PI transitions to research independence.

Candidates should select an appropriate mentor, who has both a record of funded research related to the candidate’s research topic and a successful track record as a supervisor and mentor. Candidates who are mentored by junior faculty lacking a significant track record as mentors are encouraged to identify an additional, appropriate mentor with successful mentoring experience. The sponsoring institution must ensure that the candidate has the protected time needed to conduct the proposed research and career development activities.

The sponsoring institution/organization should have a rich environment suitable to support the candidate’s research project and career development. Such an environment will include the faculty, facilities and resources needed to promote the successful progress of the candidate. When a candidate’s project requires collaborators and/or facilities at other institutions/organizations, the application should describe how the mentors, collaborators, and resources will be coordinated among the different environments.

R00 Phase: K99 awardees who have been offered, and have accepted, a full-time, tenure-track assistant professor position (or equivalent) at an extramural sponsoring institution/organization may request up to 5 years of support to continue their research as independent scientists. This R00 phase support is designed to allow the individual to establish his/her own independent research program and prepare an application for additional research grant support (e.g. NIH R01). Support for the R00 phase is not automatic and is contingent upon obtaining an appropriate extramural position at an eligible institution, an appropriate start-up package, and the successful NIH programmatic review of the individual’s progress during the K99 phase of the award.

Early transitions to the R00 phase may be permitted for individuals who have more than two 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 two year K99 phase in the application.  No early R00 phase transitions will be allowed for individuals with less than two 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.

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
Revision

The OER Glossary and the SF424 (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.

Award Budget

Award budgets are composed of salary and other program-related expenses, as described below.

Award Project Period

The mentored K99 phase is expected to last for 2 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.

Other Award Budget Information
Allowable Costs: Mentored Phase (K99)

NIDCR will contribute up to $75,000 per year toward the salary of the career award recipient.

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. Salary will be consistent with that offered scientists in similar intramural NIH positions.

Extramural: Mentored candidates at an extramural sponsoring institution/organization will be supported by NIH extramural funds. 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. The total salary requested must be based on a full-time, 12-month staff appointment. 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. Fringe benefits based on the sponsoring institution’s rate and the percent of effort are provided in addition to the salary.

NIDCR will contribute $25,000 per year toward the research development costs of 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. Research 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. 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.

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

Allowable Costs: Independent Phase (R00)

The total cost for the independent phase (R00) may not exceed $249,000 per year. This amount includes salary, fringe benefits, research costs, 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.

Indirect Costs

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.

Section III. Eligibility Information


1. Eligible Applicants


Eligible Organizations

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

For-Profit Organizations

Governments

Other

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 (K99) and independent (R00) phase, with the following exceptions: (1) Eligible agencies of the Federal government, such as the NIH intramural program, are eligible only for the mentored phase; and (2) Eligibility of organizations, other than institutions of higher education, for the R00 phase depends on the nature of the appointment, and the ability of the PD/PI to conduct independent research and apply for NIH research (R01 or R01-equivalent) grants.

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 not 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.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account and should work with their organizational officials to either create a new account or to affiliate an existing account with the applicant organization’s eRA Commons account. 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 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 PDs/PIs are not allowed.

K99 applicants must have no more than 4 years of postdoctoral research experience since their most recent doctoral degree at the time of the initial or the subsequent resubmission or revision application, and must be in mentored, postdoctoral training positions to be eligible to apply to the K99/R00 program. If an applicant achieves independence (i.e., any faculty or non-mentored research position) before a K99 award is made, neither the K99 award, nor the R00 award, will be issued.

There is no citizenship requirement for K99 applicants. An applicant may be a citizen or a non-citizen national of the United States, have been lawfully admitted for permanent residence (i.e., possess a currently valid Permanent Resident Card USCIS Form I-551, or other legal verification of such status), or be a non-U.S. citizen.

For applications submitted on behalf of non-U.S. citizens with temporary U.S. visas, visa status during each phase of the K99/R00 award must allow the PD/PI to conduct the proposed research at the applicant institution. For the K99 phase of the award, the applicant institution is responsible for determining and documenting, in the K99 application, that the candidate’s visa will allow him or her to remain in the U.S. long enough to complete the K99 phase of the award. For the R00 phase of the award, the U.S institution at which the R00 phase of the award will be conducted is responsible for determining and documenting, in the R00 application, that the PD/PI’s visa will allow the PD/PI to remain in the U.S. for the duration of the R00 award.

Candidates must have both a clinical DDS or DMD (or equivalent) degree and a PhD (or equivalent research doctoral) degree and have no more than 4 years of postdoctoral research experience (i.e. employment in a research position since completing the requirements for the doctorate) at the time of application (resubmissions must also comply with this requirement).It is not required that the degrees were earned together as part of dual degree (DSTP) training program. Candidates in a clinical faculty position that denotes independence in clinical responsibilities, but not in research, may also be eligible for the K99/R00 award.

Individuals are NOT eligible if they:

Candidates in positions other than postdoctoral fellow positions: It is recognized that some institutions appoint postdoctoral fellows in positions with other titles although they are still in non-independent, mentored training positions. Candidates in such positions are encouraged to obtain confirmation of their eligibility from NIDCR before they begin to prepare their applications. It is incumbent upon the candidate to provide evidence that his or her position complies with the intent of this eligibility requirement. If a potential applicant is in a position that is not clearly identifiable as a postdoctoral training position, the request for an exception must be accompanied by an official statement of the institution’s policy (e.g. published position description in an official institutional document) which documents the position as a mentored, postdoctoral training position.

Candidates in Cinical Faculty Positions: 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 the Program Director at the 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 (see K Kiosk) available for junior faculty development.

The following is provided as an aid to distinguish independent from non-independent positions. However, it is not sufficient merely to cite one or more of the following items to document eligibility.

Evidence for non-independence may include:

Conversely, evidence for independence, and therefore lack of eligibility, includes:

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

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:

An individual may not have two or more competing NIH career development applications pending review concurrently.  An individual may not submit a K99/R00 application if he/she has an NIH research grant, on which he/she is a PD/PI, pending review.

Level of Effort

At the time of award, the candidate must have a full-time appointment at the academic institution that is the applicant institution. Candidates (intramural or extramural) are required to commit a minimum of 75% of full-time professional effort (i.e., a minimum of 9 person-months) to their career development and research training during the mentored phase. This experience may also include activities such as completing research publications and searching for an independent faculty position. Candidates may engage in other duties as part of the remaining 25% of their 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.

R00 Phase. Although candidates are required to devote no less than 75% of their full-time, 12-month professional effort to research (i.e., full-time for 9 person-months), the required 9 person-months of research effort need not be devoted exclusively to the R00-supported research.

Mentor(s)

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 and accomplished investigator in the area of the proposed research and be committed both to the candidate’s career development and to the direct supervision of the candidate’s research. The mentor must document the availability of sufficient research support and facilities to support the candidate’s proposed research during the K99 phase.

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. The mentor, or a member of the mentoring team, should have a successful track record of mentoring individuals at the candidate’s career stage. If the primary mentor has limited training experience, a co-mentor with a strong, successful track record as a mentor should be included. The integration of this co-mentor into the K99 phase plan should be clearly described. When a mentoring team is involved, one individual must be identified as the principal mentor who will coordinate the candidate’s research and career development.

The candidate is encouraged to seek guidance from the mentor(s) in developing the research and career development plans, as well as in preparing the K99/R00 application.

Institutional Environment

The applicant institution must have a strong, well-established record of research and career development activities, as well as faculty qualified to serve as mentors in biomedical, behavioral, or clinical research.

Section IV. Application and Submission Information


1. Requesting an Application Package

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.

2. Content and Form of Application Submission

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.

Page Limitations

All page limitations described in the SF424 (R&R) Application Guide and the Table of Page Limits must be followed.

Required and Optional Components

The forms package associated with this FOA includes all applicable components, required 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 SF424 (R&R) Application Guide to ensure you complete all appropriate “optional” components.

Instructions for Application Submission

The following section supplements the instructions found in the SF 424 (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, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application (“K” Series), must be followed.   

SF424(R&R) Project/Performance Site Locations

All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application (“K” Series), must be followed.   

Other Project Information

All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application (“K” Series), must be followed, with the following additional instructions:

Project Summary/Abstract

Include a description of the research proposed for the mentored and independent phases.

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

All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application (“K” Series), must be followed. 

R&R Budget

All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application (“K” Series), must be followed, with the following additional instructions:

In the initial application, an itemized budget is not required for the R00 phase. The applicant should indicate a minimum of 9-months effort for him/herself for each project period.  The exact amount of direct and indirect costs does not need to be specified, and a zero may be used as a placeholder in these sections.  Total costs of $249,000 should be entered in Total Direct and Indirect Costs.  At the time of transition to the R00 phase, the R00 applicant institution will submit a detailed budget for each budget period of the R00 project period that reflects the direct and indirect costs at the R00 applicant institution

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 the Budget Justification.  The candidate should request $249,000 in total costs for budget periods 6 and 7, but an itemized description of costs is not required.  The applicant must also specify the dental specialty training 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.

PHS 398 Cover Page Supplement

All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application (“K” Series), must be followed, with the following additional instructions:  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.

PHS 398 Career Development Award Supplemental Form

All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application (“K” Series), must be followed, with the following additional instructions:

Candidate Information

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

Candidate’s Background

Career Goals and Objectives

Candidate's Plan for Career Development/Training Activities During Award Period

Training in the Responsible Conduct of Research

Statements and Letters of Support

All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application (“K” Series), must be followed, with the following additional instructions:

Plans and Statements of Mentor and Co-mentor(s)

Letters of Support from Collaborators and Consultants

Environmental and Institutional Commitment to the Candidate

All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application (“K” Series), must be followed, with the following additional instructions:

Description of Institutional Environment

Institutional Commitment to the Candidate’s Research Career Development

If the candidate is not a U.S. Citizen or permanent resident, the sponsoring institution must include information about the candidate’s visa status, an assurance that the candidate’s visa provides sufficient time to complete the K99 phase of the award at a U.S. institution, and assurance that there are no known obstacles (e.g. home country requirement) to the candidate obtaining a visa at the time of the R00 transition.

Research Plan

All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application (“K” Series), must be followed, with the following additional instructions:

Research Strategy

Appendix

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Planned Enrollment Report

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide. 

PHS 398 Cumulative Inclusion Enrollment Report

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide. 

Letters of Reference

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.

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. 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.

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.

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.

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

6. 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 Applying Electronically.

Important reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management (SAM). Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH. Applications that are incomplete will not be reviewed.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.

Section V. Application Review Information


1. Criteria

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.

Overall Impact

Reviewers should provide their assessment of the likelihood that the proposed career development and research plan will enhance the candidate’s potential for a productive, independent scientific research career in a health-related field, taking into consideration the criteria below in determining the overall impact score.

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.

Candidate

Career Development Plan/Career Goals & Objectives

Research Plan

Is the proposed K99 phase research significant and scientifically sound?

Mentor(s), Co-Mentor(s), Collaborator(s)

Environment & Institutional Commitment to the Candidate

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 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 Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Children 

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 children 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 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.

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 Applicable

Revisions

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.

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 mentor(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.

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.

2. Review and Selection Process

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. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

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

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

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 the DUNS, SAM 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.

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. More specifically, for K Awards, visit the Research Career Development (“K”) Awardees section of the NIH Grants Policy Statement.

Activating the Independent Phase of the Pathway to Independence Award (R00)

See also: http://grants.nih.gov/grants/new_investigators/QsandAs.htm#transDetails

Transition from the mentored phase to the independent phase is intended to be continuous in time and, except in unusual, extenuating circumstances, the awarding NIH Institute/Center will not extend the K99 phase beyond the 2-year limit. ICs may, at their discretion, make exceptions to this time limitation when individuals have been invited for faculty job interviews but final decisions have not yet been made by the potential R00 institution or, rarely, because of unusual, extenuating circumstances. 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) by the end of the K99 project period.

An eligible R00 institution will have the 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 initiative. Eligibility of for-profit organizations for the R00 phase depends on the nature of the appointment, and the ability of the PD/PI to conduct independent research and apply for NIH R01 or R01-equivalent research grants. PIs are encouraged to discuss job offers at for-profit organizations with NIH Program staff well in advance of accepting such an offer.

To avoid potential problems in activating the independent phase, applicants are strongly encouraged to contact their NIH program official as soon as plans to apply for, or assume, an independent position develop, and not later than 6 months prior to termination of the K99 phase of the award.  At that time, individuals should discuss plans for transition to, and application for, the R00 phase with their NIDCR program official. The application for the R00 phase of the award should be submitted no later than 2 months prior to the proposed activation date of the R00 award by the R00 phase grantee organization.

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:

These materials should be sent directly to the awarding Institute or Center (IC). The original application plus one copy (preferably in PDF format) are to be mailed (or e-mailed) to the Financial or Grants Management contact person of the awarding NIH Institute or Center listed in the Notice of Award. The R00 application will be evaluated by extramural Program staff of the awarding component for completeness and responsiveness to the program.

Two additional documents are included with the R00 application.  A letter from the R00 Department or Division Chairperson must be submitted that describes the R00 institution’s commitment to the candidate and plans for his/her career development (see below).  If not already provided, the final evaluation statement by the K99 phase mentor must also be provided.  

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 7 of the SF424 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% of the candidate’s full-time professional effort) at least for the duration of the R00 award. The start-up package and other institutional support must be described in detail and must be comparable to that given to other faculty recently hired into tenure-track or equivalent faculty positions. Institutions must provide a start-up 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 start-up 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 must 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 describe how the awardee’s ability to apply for and secure independent research grant (R01) support will be fostered and supported during the R00 phase of the award.

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 NIDCR program official prior to finalizing the offer. 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 reflecting the new R00 grant mechanism, 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 notification 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.

Termination of the K99 award phase

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 at an extramural institution 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.

3. Reporting

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590 or RPPR) 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. For the K99 phase, 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. 

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. Participants may be contacted after the completion of this award for periodic updates on various aspects of their employment history, publications, support from research grants or contracts, honors and awards, professional activities, and other information helpful in evaluating the impact of the program.

Section VII. Agency Contacts

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

Application Submission Contacts

eRA Commons Help Desk (Questions regarding eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Web ticketing system: https://public.era.nih.gov/commonshelp
TTY: 301-451-5939
Email: commons@od.nih.gov

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726

Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone: 301-435-0714
TTY: 301-451-5936
Email: GrantsInfo@nih.gov

Scientific/Research Contact(s)

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

Peer Review Contact(s)

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

Financial/Grants Management Contact(s)

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

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Authority and Regulations

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.  


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