Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 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. 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.

The objective of this NIDCR Short-Term Mentored Career Enhancement Award in Dental, Oral and Craniofacial Research for Mid-Career and Senior Investigators (K18) is to provide mid-career or senior investigators with salary and research support over a short-period of time to support a mentored career enhancement experience in the theories, tools, methods or approaches of a scientific field different from their own, in order to enrich and expand an existing research program in dental, oral and craniofacial research, or to bring dental, oral and craniofacial research to existing research in other scientific fields.

This FOA focuses on established investigators holding the academic rank of Associate Professor or Professor, or the equivalent in non-academic research settings, who have records of scientific accomplishment and independent, peer-reviewed Federal or private research grant funding. Candidates are not required to have active research grant support at the time of application. The purpose of the award is to provide candidates with support for short-term, intensive mentored research experiences over a period of two and a half to twelve months to acquire new research capabilities within the NIDCR research mission. Candidates must identify one or more mentors with extensive research experience in an appropriate domain or discipline, who are established, well-qualified, and willing to sponsor the short-term research career development experience. It is expected that the proposed career enhancement plan will represent a novel extension of the research of the candidate. Such experiences will afford candidate investigators protected time to 1) seek training with established investigators from another field, in order to enrich their existing dental, oral and craniofacial research program; or 2) seek training with established dental, oral and craniofacial research investigators in order to facilitate the introduction of dental, oral and craniofacial research into the candidate's existing research program.

The research career enhancement experience may be conducted in a different department within the candidate's home institution or different institutional setting from the location where they hold their primary appointment. The host mentoring laboratory/research program is expected to demonstrate appropriate research and resources to provide a new research direction for the candidate. In other cases, the candidate and the proposed host laboratory/research program will not have any previous research collaborations, but candidates may propose such arrangements with justification as to why this program will facilitate the goals of this FOA in a manner that could not be achieved solely through a research grant or current collaborative arrangement.

This FOA supports short-term mentored research training in two general areas: behavioral and social sciences, and genetic and genomic research. Applications should be consistent with the research priorities of the NIDCR Behavioral and Social Sciences Research Branch (BSSRB) and/or the NIDCR Translational Genomics Research Branch (TGRB). Additional information about the priorities of NIDCR's Behavioral and Social Sciences Research Branch can be found at: http://www.nidcr.nih.gov/Research/DER/BSSRB.htm. Additional information about the priorities of NIDCR's Translational Genomics Research Branch can be found at http://www.nidcr.nih.gov/Research/DER/TGRB/. Prospective applicants are encouraged to contact an NIDCR program official from either of these branches to discuss their research goals, NIDCR specific programmatic information, and the research priorities listed below. Applications addressing other areas of research will not be be considered for funding.

This FOA does not support clinical intervention studies. NIDCR guidelines for investigators who wish to propose a clinical intervention study are found at http://www.nidcr.nih.gov/Research/DER/ClinicalResearch/ClinTrials.htm.

The NIDCR behavioral and social sciences program supports both basic and applied research to promote oral health, to prevent oral/dental diseases and related disabilities, and to improve management of craniofacial conditions, disorders and injury. Mentored experiences are encouraged that facilitate the application of theories, tools, methods or approaches from the behavioral or social sciences to oral health challenges. Examples of candidate-mentor pairings, and associated projects, are listed below for illustrative purposes. This list does not imply preference for these specific example projects:

* An investigator with expertise in analyzing national oral health data seeks mentorship from an investigator in causal modeling; the candidate learns innovative statistical techniques and methodologies to identify causal relationships, and the two work together on a simulation study that allows testing alternative causal hypotheses.

* An investigator in oral health disparities seeks mentorship from an investigator in systems science; the candidate learns the methods and tools of system science, and the candidate analyzes the mentor's data set, asking an oral health or health disparities question.

* An investigator in adherence to asthma medication seeks mentorship from a dentist-scientist; the candidate learns the adherence challenges in dentistry, and the two collaborate on a small project in which they identify ways in which adherence principles could be applied in the dental clinic.

* An investigator in children's oral health seeks mentorship from an investigator with expertise in research on parenting; the candidate learns the theories, measures and methods of family research, and the two work together on a project to develop and test a measure to capture potentially relevant family dynamics in the dental clinic.

* An investigator who studies peer influence among adolescents seeks mentorship from a pediatric dentist-scientist; the candidate learns about the parameters of pediatric dentistry, and the two collaborate on a study that identifies sources of peer influence that might be leveraged in a subsequent oral health study.

* An investigator with a strong track record in dissemination and implementation science seeks mentorship from a clinical investigator who works in dental practice-based research; the candidate learns about the clinical, organizational and policy challenges in dental practice, and the two design a survey to better understand how evidence based practices are adopted in dental practice.

Scientific areas of highest priority for Genetics/Genomics applications are laboratory and/or statistical analyses and interpretation of genetic and genomic data which may include DNA genotyping and/or sequencing, epigenetics/epigenomics, and/or gene expression. Projects may involve research on inherited susceptibility or normal variation related to oral and craniofacial health and disease, the human microbiome or somatic changes in oral cancer.

Examples may include but are not limited to:

* A clinical researcher studying an oral disease seeks mentorship from an investigator in genomic laboratory methods, and the two collaborate on a project that makes use of stored samples from a previous study.

* An epidemiologist working with a national oral health database seeks mentorship from an investigator with expertise in statistical analysis of genetic/genomic data, and the two complete a project using data available thru the NIH's database of Genotypes and Phenotypes (dbGaP).

* An investigator in DNA sequencing seeks mentorship from an investigator with expertise in a particular oral disease, and the two design a study to identify potential genetic markers for the oral disease.

* A dentist-scientist seeks mentorship from an investigator with expertise in bioinformatics, and the two pilot-test an innovative approach to analyzing clinical and genomic data.

*Investigators partner to study the oral microbiome and its role in oral health and disease.

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

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

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)
• Eligible Agencies of the Federal Government
• U.S. Territory or Possession

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

• Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
• System for Award Management (SAM) (formerly CCR) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
• NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
• eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

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

All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

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.

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

Candidates for this award must have a research or health professional doctoral degree, or a combined health-professional and research doctoral degree.The award is intended for well-established investigators at the academic rank of Associate Professor or Professor, or the equivalent in non-academic settings, who have established records of independent, peer reviewed Federal or private research grant funding. Applicants are not required to have active research grant support at the time of application for this award.

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.

The NIH will not accept duplicate or highly overlapping applications under review at the same time. An individual may not have two or more competing NIH career development applications pending review concurrently. In addition, NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101).

At the time of award, the candidate must have a full-time appointment at the academic 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. 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 mentor, or a member of the mentoring team, should have a successful track record of mentoring individuals at the candidate’s career stage. The candidate must work with the mentor(s) in preparing the application.

Institutional Environment

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

Applicants must obtain 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, including Supplemental Grant Application Instructions 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.

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

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.

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

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

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

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

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

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

The PHS 398 Career Development Award Supplemental Form is comprised of the following sections:

Candidate

Research Plan

Other Candidate Information

Mentor, Co-Mentor, Consultant, Collaborators

Environment & Institutional Commitment to the Candidate

Human Subjects Sections

Other Research Plan Sections

Appendix

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

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

Candidate Information and Goals for Career Development

Candidate s Background

• Describe the candidate's prior training and accomplishments in health related research to date, including publications, prior research interests and experience, and history of research support.
• Describe the candidate's commitment to a career in dental, oral and craniofacial research research.
• Describe how this career enhancement program has the potential to augment the candidate's research career and ultimately have an impact on science.
• Include a statement that the candidate will commit 2.4 to 6 person-months of full time professional effort to the short-term career enhancement program. Include a description of the candidate’s professional responsibilities and show their relationship to the proposed activities of the career enhancement award.
• It is expected that either the candidate or the mentor has sufficient research funding to support the proposed shared research project, in excess of the allowable costs of this award. If applicable, describe how the candidate s independent research support will cover the costs of the proposed research project that will not be covered by this award or by the mentor’s independent research support.
• Provide evidence of the candidate’s ability to interact and collaborate with other scientists, particularly those from other disciplines.

Career Goals and Objectives

• Describe the candidate’s objectives and long term career plans, and how these relate to the proposed activities in the career enhancement award, with a focus on how the proposed work will lead to rigorous dental, oral and craniofacial research
• Justify the need for further career enhancement in relation to the candidate’s future research goals.

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

• The candidate and the mentor are jointly responsible for the preparation of the career development plan. A timeline is often helpful. The candidate and mentor may propose a mentoring team (or an Advisory Committee).
• Provide details of the career enhancement plan, including the research and academic enrichment components (e.g., such as classes, seminars, and opportunities for interaction with other groups and scientists if applicable), tailoring it to the candidate’s goals, prior experience and career level, as well as the intent of the K18 award.
• The candidate should describe any new or enhanced research skills, approaches and knowledge he/she will acquire during the career award period, and how these skills and experiences will significantly enhance his/her ability to engage in rigorous dental, oral and craniofacial research.
• If thecandidate proposes to work with a mentor with whom they have had previous research collaboration, include justification as to why this mentored expwerience will facilitate career development that could not be achieved solely through a research grant or collaborative arrangement.
• Provide a systematic plan for progression of activities for the period of the award and beyond to exploit the career enhancement activities provided by the K18, emphasizing the potential to enhance an existing research program in dental, oral and craniofacial research, or to bring dental, oral and craniofacial research to existing research in other scientific fields.

Research Plan Section

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

Research Strategy

• A sound research project that is consistent with the candidate s level of research development and objectives of his/her career development plan must be provided. The research description should demonstrate not only the quality of the candidate’s research thus far but also the novelty, significance, creativity and approach, as well as the ability of the candidate to carry out the proposed research.
• A research project in the behavioral and social sciences or genetic and genomic research that is consistent with the goals of this FOA and the objectives of the career enhancement program should be described.
• The application must also describe the relationship between the mentor’s research and the candidate’s proposed research plan.
• Athough it is not expected that the description of the research would be as detailed as an application for an investigator-initiated research grant (e.g., R01), enough information should be provided to permit an evaluation of the scientific merit of the candidate's research activities and mentored research training.

Training in the Responsible Conduct of Research

• All applications must include a plan to fulfill NIH requirements for instruction in the Responsible Conduct of Research (RCR). See SF424 (R&R) Application Guide for instructions.

Mentor, Co-Mentor, Consultant, Collaborators Section

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

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

• The candidate must name a primary mentor (sponsor), who, together with the candidate, is responsible for the planning, direction, and execution of the program. The candidate may also identify co-mentors as appropriate to the goals of the program.
• The mentor(s) should be recognized as an accomplished investigator in the proposed research area and have a track record of success in training independent investigators.
• It is expected that the either the candidate or the mentor has sufficient research funding to support the proposed research project in excess of the allowable costs of this award. The mentor(s) should describe any independent research support that will cover the costs of the proposed research project that will not be covered by this award or by the candidate s independent research support.

The application must include a statement from the mentor providing: (1) information on his/her research qualifications and previous experience as a research mentor; (2) a plan that describes the nature of the mentoring that will occur during the proposed award period, including how the Candidate’s research career enhancement objectives will be promoted; (3) the ongoing research activities and research grant support of the mentor(s), along with how the research activities of the candidate will dovetail with the mentor's research program. Each mentor and co-mentor(s) must provide a statement of his/her areas of expertise and responsibility. Co-mentors should clearly describe how they will coordinate mentoring of the candidate. If any of the co-mentors is not located at the sponsoring institution, a statement should be provided describing the mechanism(s) and frequency of communication with the candidate, including the frequency of personal meetings.

Letters of Support from Collaborators, Contributors and Consultants

• Signed statements must be provided by each collaborator, contributer, and/or consultant confirming their participation in the project and describing their specific roles. Collaborators and consultants generally do not need to provide their biographical sketches. However, information should be provided that clearly documents expertise in the proposed area(s) of collaboration/consultation. Any other opportunities for the candidate s professional growth should also be documented in these statements.
• Advisory Committee members (if applicable): Signed statements must be provided by each member of the proposed Advisory Committee. These statements should confirm their participation, describe their specific roles, and document the expertise they will contribute. BTheir biographical sketches to not have to be provided.

Environmental and Institutional Commitment to the Candidate

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

Description of Institutional Environment

• Describe the host institution's scientific environment, including the resources and facilities that will be available to the candidate.
• Describe how the research environment of the host program and institution is particularly suited for the advanced development of the candidate’s research career and the pursuit of the proposed research plan.
• The research environment and the availability and quality of needed research facilities and research resources (e.g., equipment, laboratory space, computer time, that will be made available to the candidate must be described. In cases in which research resources will be provided by the host laboratory.

Institutional Commitment to the Candidate’s Research Career Development

• The candidate’s home institution must provide a clear and unambiguous statement of assurance that during the active period of the K18 award the candidate will be able to devote a minimum of 2.4 to 6 person months of full time professional effort to the research career enhancement program. The institutional statement should also indicate what, if any, duties or commitments the candidate will continue to maintain, including how any grant, teaching or administrative responsibilities will be handled, if needed.
• The host (mentor's) institution must provide assurances that appropriate time and support for any proposed mentor(s) and/or other staff consistent with the career enhancement plan will be provided.

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.

Form only available in FORMS-D application packages for use with due dates on or before January 24, 2018.

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

Form only available in FORMS-E application packages for use with due dates on or after January 25, 2018.

When involving NIH-defined human subjects research, clinical research, and/or clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered "Yes" to the question "Are Human Subjects Involved?" on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the SF424 (R&R) Application Guide must be followed with the following additional instructions:

• For FOAs that do not allow independent clinical trials, do not complete Section 4 - Protocol Synopsis information or Section 5 - Other Clinical Trial-related Attachments.

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

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

Letters of reference are not required.

See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov.

Part I. Overview Information contains information about Key Dates and Times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies) using ASSIST or other electronic submission systems. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date. and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

This initiative is not subject to intergovernmental review.

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

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

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. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. For assistance with application submission contact the Application Submission Contacts in Section VII.

Important reminders:

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

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

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review, NIH. Applications that are incomplete or non-compliant will not be reviewed.

In order to expedite review, applicants are requested to notify Dr. Yasaman Shirazi, Chief of the Scientific Review Branch, NIDCR by email at [email protected] when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.

Applicants are required to follow our Post Submission Application Materials policy.

Important Update: See NOT-OD-18-229 for updated review language for due dates on or after January 25, 2019.

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 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.

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

• Is the candidate's prior training and research experience appropriate for this award?
• Is the candidate's academic, clinical (if relevant) and research record of high quality?
• Is there evidence of ongoing, high quality research productivity as evidenced by contributions to the scientific literature and success in obtaining independent funding? Has the candidate demonstrated the ability to conceptualize and organize a long-term research approach?
• For candidates new to dental, oral and craniofacial research, does the candidate have the potential to develop as an independent and productive researcher in dental, oral and craniofacial research?
• For candidates established in dental, oral and craniofacial research, does the candidate have the potential to expand his/her existing research program to incorporate new theories, tools, methods or approaches?
• Is the career enhancement experience likely to augment the candidate’s research career?
• Does the candidate demonstrate adequate requisite commitment of 2.4 to 6 person-months of full-time professional effort to the short-term career enhancement program?
• Does the candidate demonstrate adequate evidence of his/her ability to interact and collaborate with other scientists, particularly with those from other disciplines?

Career Development Plan/Career Goals and Objectives/Plan to Provide Mentoring

• What is the likelihood that the career enhancement and mentoring plans will contribute substantially to the scientific development of the candidate leading to rigorous dental, oral and craniofacial research?
• Is there an adequate description of the need for further career enhancement of the candidate as it relates to rigorous dental, oral and craniofacial research?
• Is the description of the progression of research experiences likely to enhance the candidate's ability to engage in new areas of dental, oral and craniofacial research?
• Are the career goals, objectives and scope of the plan appropriate, when considered in the context of prior research experience, and the proposed training experience and research aims?

Research Plan

• Is there a strong scientific premise for the project?
• Has the candidate presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed?
• Has the candidate presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?
• Are the proposed research question(s), design and methodology of significant scientific and technical merit?
• Is the research plan relevant to the candidate’s research career objectives?
• Is the research plan appropriate to the stage of research development and as a vehicle for developing the research skills described in the career enhancement plan?
• Is the research plan appropriate in developing a rigorous research program in dental, oral and craniofacial research?
• Is the proposed research a novel extension of the research of the candidate? In cases where the candidate and the proposed host laboratory/research program have previous research collaborations, is there sufficient justification as to why this program will facilitate career development that could not be achieved solely through a research grant or current collaborative effort?

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

• Are the mentor's research qualifications in the area of the proposed research appropriate?
• Is there adequate description of the quality and extent of the mentor's proposed role in providing guidance and advice to the candidate?
• To what extent are the mentor's research qualifications and experience, and scientific stature and mentoring track record appropriate for the candidate's career development needs?
• Is there evidence of the mentor's previous experience in fostering the development of independent investigators?
• Is there evidence of the mentor's research productivity and peer-reviewed support?
• How well do the research activities of the candidate dovetail with the mentor's research funding and ongoing activities?
• Do the mentor and his/her host institution have adequate resources available to the candidate to conduct the proposed research?
• Is the source(s) of funding, beyond what is provided by the K18 award, described and adequate for all of the proposed career enhancement activities and research?
• Are there signed statements from consultants/contributors that clearly state their role(s) in the career development of the candidate?
• If co-mentors, consultants, and/or collaborators are identified, is there adequate description of roles and how each person will contribute to the career enhancement of the candidate? Is the coordination of mentoring reasonable? Will there be adequate communication and personal meetings with the candidate?

Environment & Institutional Commitment to the Candidate

• Is the institutional commitment to the career development of the candidate appropriately strong?
• Is there a strong commitment from the candidate's home institution to ensure that 2.4-6 person-months of the candidate’s full time professional effort that will be dedicated to the research career enhancement plan during the active period of the award?
• Are the research facilities, resources and training opportunities, including faculty capable of productive collaboration with the candidate, adequate and appropriate?
• Is the environment for scientific and professional development of the candidate of high quality?
• Are the host laboratory/research program and institution well suited for the advanced development of the candidate’s research career and the pursuit of the proposed career enhancement activies and research plan?
• Is there a strong commitment for the success of the mentored experience, including the proposed research project, from the mentor's (host) institution?

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

For research that involves human subjects but does not involve one of the 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.

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.

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Not Applicable

Not Applicable

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

All applications for support under this FOA must include a plan to fulfill NIH requirements for instruction in the Responsible Conduct of Research (RCR). Taking into account the level of experience of the 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.

Reviewers will assess the information provided in this section of the application, including (1) the Select Agent(s) to be used in the proposed research, (2) the registration status of all entities where Select Agent(s) will be used, (3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and (4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3) Genomic Data Sharing Plan (GDS).

Authentication of Key Biological and/or Chemical Resources

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

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) convened by the NIDCR, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.

• Will receive a written critique.

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

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

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.

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.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.

For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and https://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement. The Supplemental Instructions for Individual Career Development (K) RPPRs must be followed.

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.

eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Finding Help Online: https://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

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

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-945-7573

Lynn Mertens King, PhD
Research Training and Career Development Branch
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-594-5006
Email: [email protected]

David Clark, DrPH
Behavioral and Social Sciences Research Branch
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-594-4814
Email: [email protected]

Emily L. Harris, PhD, MPH
Translational Genomics Research Branch
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-594-4846
Email: [email protected]

Yasaman Shirazi, PhD
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-594-5593
Email: [email protected]

Dede Rutberg, MBA
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-594-4798
Email: [email protected]

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 Part 74 and 92.