It is critical that applicants follow the Training (T) 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 programs is to help ensure that a diverse pool of highly trained scientists is available in appropriate scientific disciplines to address the Nation s biomedical, behavioral, and clinical research needs. More information about Career programs may be found at the NIH Extramural Training Mechanisms website.

This FOA encourages applications from organizations that propose creative and innovative institutional research career development programs in the mission area(s) of the NIDCR.

The proposed institutional research career development program may complement other, ongoing research training and career development programs at the applicant institution, but the proposed career development experiences must be distinct from those career development programs currently receiving Federal support.

This K12 institutional career development program is intended to provide support for the research career development of early career stage dentist scientists (scholars) to facilitate their transition to careers as independent investigators and leaders in the full scope of dental, oral and craniofacial health research. A goal of the program is to prepare scholars to lead vibrant and active research programs in basic, translational or clinical research, participate as expert investigators in multidisciplinary team science approaches, and provide leadership in biomedical, behavioral and social science research among academic partners, community practitioners and health professional organizations.

A pivotal point in the research career development of dentist scientists is the decision to pursue dental specialty training or research training after completing the dental degree. This program addresses the need for an established and structured pathway in dental schools that develops both clinical and research competencies of these early career dentists, especially those that aspire to leading academic research careers. The purpose of the NIDCR Dental Specialty and PhD Program (DSPP) is to encourage institutions to develop and sustain programs that provide combined and integrated PhD research training and clinical dental specialty training for dentists. Dental schools are encouraged to create programs that will foster the recruitment, training, and retention of a robust dentist scientist research workforce.

Programs will provide intensive supervised research training and career development experiences leading to a PhD in a field relevant to dental, oral and craniofacial research, and advanced clinical knowledge and skills development in one of the nine dental specialty programs recognized by the American Dental Association (ADA). As such, programs should include the participation of program directors or faculty in the proposed dental specialty training who are experienced mentors and are committed to the scholars' successful completion of the specialty program(s). Faculty for the PhD research training component of the program should be experienced mentors and established investigators who have active research funding to support the scholar's research activities. All mentors must be committed to supporting the scholar's clinical and research activities throughout the proposed DSPP.

Applicant institutions must have well-established research, research career development, and clinical programs, and adequate numbers of highly qualified faculty in clinical departments and departments supporting graduate research training. The environment is expected to stimulate interactions among research scientists and clinical investigators. The Program Director/Principal Investigator (PD/PI) and applicant institution are encouraged to develop innovative and multidisciplinary programs that maximize the research and educational resources of the institution and any collaborating institutions and organizations such as Schools of Dentistry, Medicine and Departments of Chemistry, Engineering, Computational Biology and Bioinformatics, and not-for-profit and private organizations.

An institution receiving a K12 DSPP award is expected to recruit and select scholars who have the potential to develop into independent investigators. Institutions are encouraged to develop novel mechanisms for recruiting qualified dentist scholars to the DSPP. Networking and mentoring opportunities with other early career investigators and clinician scientists should be made available and are encouraged. Programs should consider leveraging resources available at the institution or among dental schools or other organizations such as national scientific or professional organizations to foster a robust DSPP experience for the scholars.

The program must include a dental specialty component and a PhD research component. Applicant institutions are expected to develop programs that can be individually tailored to meet the unique research and clinical development needs of each scholar and ensure that they complete the program with requisite competencies in both areas. The clinical development component must ensure that the scholar acquires requisite advanced clinical knowledge and skills in a dental specialty currently recognized by the American Dental Association. A specialty certificate or Master's degree and a PhD degree are required to document successful completion of the combined DSPP program. Activities associated with the advanced clinical specialty training are expected to be integrated with the PhD research training, but are not supported by the K12 award.

The research component must be a doctoral level (PhD or equivalent) program that is consistent with the applicant institution's PhD degree requirements and the objectives of the DSPP. Programs are expected to include both didactic training and supervised research experiences designed to accommodate scholars with varying levels of research experience. Scholars with limited research experience in a given field may engage in a structured, phased developmental program, including a designated period of didactic training followed by a period of supervised research experience. Although scholars with limited research experience can be appointed to the program, they should be prepared to apply for independent career development or research funding by completion of the program. The research experience may use a basic, translational science or clinical science approach to problems in dental, oral and craniofacial health research, and should prepare the scholar for an active research career. Instruction and participation in team science-based research approaches should be considered, depending upon the goals of the proposed DSPP. NIH also strongly encourages, but does not require, institutions to develop and use Individual Development Plans (IDPs) for graduate students and postdoctoral researchers supported by NIH awards, regardless of their position title (NOT-OD-14-113).

Programs should provide scholars with instruction and training in laboratory and project management, in oral and written presentations, and with skills needed to apply for NIH individual career development (K) awards or research project grant support. All scholars should be expected to submit applications for individual career development awards (K) before they complete the DSPP.

Features and Requirements:

1) The K12 supports the PhD research training phase of 1 or 2 scholars per year, each year of the award.

2) Each scholar must be appointed to the K12 for a minimum of 3 and up to 5 consecutive years of support. All K12 appointments must be 12 months in duration.

3) Each scholar is required to devote 3 years at a minimum of 9 person months (equivalent to 75% of full-time professional effort) conducting research related to the PhD program.

4) Scholars appointed for 4 or 5 years may devote one or two of those years, respectively, at a minimum of 6 person months (equivalent to 50% of full-time professional effort) conducting research related to the PhD program. The remaining effort must be devoted to activities related to the dental specialty component of the DSPP.

5) A minimum of 50% continuous and consistent full time professional effort towards research must be maintained during all PhD research periods. For example, 75% full time professional effort could be met by 6 months at 50% effort and 6 months at 100% effort, or by 12 months at 75% effort.

6) The structure, phasing and level of effort devoted to the dental specialty vs PhD research training in each year of the DSPP should be described under the Career Development Program Plan.

As long as these appointment and effort requirements are met, the structure and phasing of the DSPP is developed by the applicant institution. Institutions may plan for an individual to begin or complete specialty training prior to or following the duration K12 support.

An example of a six-year DSPP program with five consecutive K12 appointments supporting PhD research career development at 75% or 50% full time professional effort:

Year in DSPP	Specialty Training Effort	PhD Research Effort	Specialty Training Support	PhD/K12 Support
Year 1	100%	0%	Other source	Not appointed
Year 2	25%	75%	Other source	12 month appt.
Year 3	25%	75%	Other source	12 month appt.
Year 4	25%	75%	Other source	12 month appt.
Year 5	50%	50%	Other source	12 month appt.
Year 6	50%	50%	Other source	12 month appt.

The K12 will provide support for the scholar's PhD research training component of the DSPP. The K12 will not support the clinical specialty training component. To maximize the likelihood of an early-career dentist completing both the dental specialty and the PhD research training, applicant institutions are strongly encouraged to complement the proposed K12 supported PhD research training with support for the development of the scholar's dental specialty skills and knowledge through non-federal or private sources. The complementary activities for dental specialty training would be supported by separate applicant-secured funding and would be independent of the K12 funding for the scholar's research career development.

Note: This Funding Opportunity Announcement (FOA) allows appointment of Scholars proposing to gain research experience in a clinical trial led by a mentor or co-mentor, as part of their research and career development.

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

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

Governments

• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)
• U.S. Territory or Possession

Other

• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations

The sponsoring institution must assure support for the proposed program. Appropriate institutional commitment to the program includes the provision of adequate staff, facilities, and educational resources that can contribute to the planned program.

Applicant institutions are encouraged to develop creative partnerships with organizations that have interests in, and are committed to, developing the dentist-scientist research workforce. The partnerships may extend opportunities, for example, for unique mentorship opportunities, or provide other resources, including non-federal support for the scholar during the dental specialty component of the DSPP.

The applicant institution must have a strong and high-quality research program in the area(s) proposed under this FOA and must have the requisite faculty, staff, potential scholars and facilities on site to conduct the proposed institutional program. In many cases, it is anticipated that the proposed program will complement other ongoing career development programs occurring at the applicant institution and that a substantial number of program faculty will have active research projects in which participating scholars may gain relevant experiences consistent with their research interests and goals.

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.

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 individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research training program as the Training Program Director/Principal Investigator (Training PD/PI) is invited to work with his/her 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.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF 424 (R&R) Application Guide.

The PD/PI should be an established and active investigator in dental, oral and craniofacial research, have experience in research training, and should be capable of providing both administrative and scientific leadership to the development and implementation of the proposed program. The PD/PI is expected to have active peer-reviewed research funding at the time of application and ongoing independent peer-reviewed research support at NIH R01 or R01 equivalent levels in dental, oral and craniofacial research.

Multiple PD(s)/PI(s) are encouraged, such as a PD/PI who is an experienced investigator and has active peer reviewed research funding, and a PD/PI who is a clinician scientist and a director of a dental specialty program recognized by the American Dental Association. If multiple PD(s)/PI(s) are proposed, they must have complementary expertise and the potential to enhance multidisciplinary/interdisciplinary research training opportunities. At least one PD/PI of a multiple PD/PI application must have active peer-reviewed research support at the time of application and be expected to have ongoing peer-reviewed research funding.

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:

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

Program faculty should have strong records as researchers, including recent publications and successful competition for research support in the area of the proposed research training program. Program faculty should also have a record of research training, including successful, former trainees who have established productive careers relevant to the NIH mission. Researchers from diverse backgrounds, including racial and ethnic minorities, persons with disabilities, and women are encouraged to participate as mentors.

Each scholar appointed under the DSPP K12 should have minimum of two mentors: one mentor for the dental specialty training component and a primary mentor for the PhD research training component. Additional mentors are optional. All mentors must be committed to working as a team to ensure each scholar's success in completing the DSPP.

Mentors for the graduate dental specialty program must be directly involved in the proposed clinical specialty training program, either as a Program Director or faculty member, and have the experience and expertise to develop the advanced knowledge and skills for competency in the specialty practice and to develop future leaders in research and clinical aspects of the specialty.

The PhD research mentors are expected to be active investigators in dental, oral and craniofacial research, have a successful record of providing career development and research training activities, and have a successful record of mentoring. Evidence of successful mentoring includes former student's research productivity, such as peer reviewed publications and patents, transition to research intensive or research related positions, and the ability to obtain independent peer reviewed research funding. Proposed mentors should have independent NIH research funding (e.g., R01, R21) or equivalent at the time of the K12 award. Mentors are expected to make available their expertise, guidance, and laboratory facilities and resources to support the scholars and their PhD dissertation research projects, and be committed to mentoring the scholars throughout their total period of career development in the DSPP.

If a Scholar will be proposing to gain experience in a clinical trial as part of his or her research career development, the mentor or a member of the mentoring team must include a statement to document leadership of the clinical trial, and appropriate expertise to guide the Scholar in any proposed clinical trials research experience.

Scholars to be supported by the institutional career development program must be at the postdoctoral or junior faculty level. NIH encourages appointment of individuals from underrepresented racial and ethnic groups as well as individuals with disabilities.

Scholars must be citizens or noncitizen nationals of the United States or have been lawfully admitted for permanent residence at the time of appointment. Additional details on citizenship requirements are available in the NIH Grants Policy Statement.

Scholars must have a DDS, DMD, or equivalent doctoral degree from an accredited domestic or foreign institution. Documentation by an authorized official of the degree-granting institution certifying all degree requirements have been met prior to the beginning date of the scholar appointment is acceptable.

Clinicians who have completed a PhD or equivalent research degree are not eligible. Individuals who have completed advanced clinical knowledge and skills development in an ADA recognized dental specialty are not eligible.

Candidates may not have had a previous mentored career development award, including institutional mentored career development support. Current and former PD/PIs on NIH research project grants or equivalent non-PHS peer-reviewed research grants over $100,000 direct costs per year are ineligible.

During the period of this award, scholars may not accept or hold any other PHS award that duplicates the provisions of this institutional career development award. However, scholars are strongly encouraged to apply for individual mentored career development awards (e.g., K08, K23) during the K12 support, provided they meet the eligibility requirements of those programs. NIDCR supports research training leading to a PhD and postdoctoral research training under these career development awards. If a scholar competes successfully for an individual K award, the K12 appointment would be terminated and funding would be provided by the new individual K, and conform to individual K policies on level of effort. Dentists who earn a PhD under an NIDCR institutional K12 and/or individual K award remain eligible for the NIDCR Pathway to Independence Award K99/R00 award. In addition, DSPP scholars may apply for independent research grant support (e.g., R03, R21, R01) during the K12 appointment period or during an individual K award to further support their research career trajectory.

Scholars should contact NIDCR staff if there are any questions regarding eligibility.

Buttons to access the online ASSIST system or to download application forms are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

It is critical that applicants follow the Training (T) Instructions in the SF424 (R&R) Application Guide i 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.

Letter of Intent

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

• Descriptive title of proposed activity
• Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity

The letter of intent should be sent to:

Yasaman Shirazi, PhD
Telephone: 301-594-5593
Fax: 301-480-8303
Email: [email protected]

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

Instructions for Application Submission

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

Follow all instructions provided in the SF424 (R&R) Application Guide.

Follow all instructions provided in the SF424 (R&R) Application.

Follow all instructions provided in the SF424 (R&R) Application, with the following additional modifications:

Substitute the term scholars for all references to trainees in the SF424 (R&R) Application Guide, and substitute the term career development for all references to training in the SF424 (R&R) Application Guide.

Project Summary/Abstract. Provide an abstract of the entire application. Include the objectives, rationale and design of the research career development program, as well as key activities in the training plan. Indicate the planned duration of appointments, the projected number of scholars including their levels (i.e., postdoctoral, junior faculty), and intended scholar outcomes.

Other Attachments. An Advisory Committee is not a required component of a K12 Career Development Program. However, if an Advisory Committee is intended, provide a plan for the appointment of an Advisory Committee to monitor progress of the career development program. The composition, roles, responsibilities, and desired expertise of committee members, frequency of committee meetings, and other relevant information should be included. Describe how the Advisory Committee will evaluate the overall effectiveness of the program. Proposed Advisory Committee members should be named in the application if they have been invited to participate at the time the application is submitted. Please name your file Advisory_Committee.pdf .

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

Follow all instructions provided in the SF424 (R&R) Application.

Follow all instructions provided in the SF424 (R&R) Application.

Follow all instructions provided in the SF424 (R&R) Application Guide, with the following additional modifications:

Follow all instructions provided in the SF424 (R&R) Application Guide with the following additional modifications:

• Include all personnel other than the K12 PD(s)/PI(s) in the Other Personnel section, including clerical and administrative staff. Also include proposed salary costs for planned scholars.
• Do not complete the section on Participant/Trainee Support Costs.

The PHS 398 Research Training Program Plan Form is comprised of the following sections:

• Career Development Program
• Faculty, Scholars and Training Record
• Other Career Development Program Sections
• Appendix Note that the Appendix should only be used in circumstances covered in the NIH policy on appendix materials.

Follow all instructions provided in the SF424 (R&R) Application Guide with the following additional modifications:

Particular attention must be given to the required Training Data Tables. Applicants should summarize, in the body of the application, key data from the tables that highlight the characteristics of the applicant pool, faculty mentors, the educational and career outcomes of individuals with similar experiences in pursuing dental specialty training and PhD research training in a combined and integrated program, and other factors that contribute to the overall environment of the program.

Tables 2 and 4 are required. Table 8C Part III Recent Graduates for NEW applications should be included, if applicable. For this FOA, Table 8C Part III should provide the outcomes of dentist scientists completing programs in the past five years who may or may not have been eligible for appointment to this K12 DSPP program (U.S. citizens or permanent residents and non-citizens).

Substitute the term scholars for all references to trainees in the SF424 (R&R) Application Guide, and substitute the term career development for all references to training in the SF424 (R&R) Application Guide.

Career Development Program

Program Plan

Program Administration.

Describe the acknowledged strengths, leadership and administrative skills, mentoring experience, scientific expertise, and active research of the PD(s)/PI(s). If multiple PD(s)/PI(s) are proposed, describe their complementary leadership and expertise in administering the program, and relate these strengths to the proposed management of the K12 career development DSPP. Describe the respective roles of those in leadership positions and the planned strategy and administrative structure to be used to oversee and monitor the program. Include milestones to be used to monitor scholar progress in the dental specialty component and the PhD component, and in the coordination of activities in the overall DSPP. If there are multiple PDs/PIs, then the plan for Program Administration is expected to synergize with the Multiple PD/PI Leadership Plan section of the application.

Institutions must provide evidence of the ability to establish or successfully implement an integrated specialty and PhD training program for dentist scientists, including coordination among participating schools and departments within the dental, medical and other graduate schools.

Describe recruitment plans and criteria for selecting dentists to participate in the DSPP and to be appointed as K12 scholars. A timeline of activities for the DSPP, including recruitment activities, and the selection and appointment of scholars should be included.

Institutions with existing research training or career development programs must explain what distinguishes this K12 program from the others, how their programs will synergize with one another, if applicable, and make it clear that the pool of faculty, potential scholars, and resources are robust enough to support an additional K12 program. When a program administrator position is planned, a description of the scientific expertise, leadership, and administrative capabilities essential to coordinate a program for developing investigators must be included in the application.

Proposed Career Development Program.

Describe the objectives of the proposed DSPP, including the dental specialty training components and the PhD graduate research areas offered under the DSPP. Detail the structure, phasing, and duration of the combined Dental Specialty and PhD program, along with the level of effort devoted to the dental specialty and/or PhD research training in each year of the DSPP.

Clearly identify the PhD research phase supported by the K12, including the 3 to 5 consecutive years of 12 month scholar appointments, and the required minimum of 9 person month (equivalent to 75% full time professional effort) devoted to the PhD component, per year, for no less than three years. Scholars appointed to the K12 for four to five consecutive years may devote a minimum of 6 person months (equivalent to 50% full time professional effort), for one or two of those years, respectively. Note, a minimum of 50% continuous and consistent full time professional effort towards research must be maintained during all PhD research periods.

Include information about planned courses, seminars, workshops, mentored research experiences, and any activities that will be incorporated into the career development program. Identify activities that will foster the research career development of the scholars, including instruction and training in laboratory and project management, in oral and written presentations, and skills needed to apply for NIH individual career development (K) awards or research grant support. All scholars should be expected to submit applications for individual career development awards (K) before they complete the DSPP.

Provide a plan and timeline to monitor progress of the scholars in the DSPP, and an administrative structure that facilitates successful adherence to this anticipated timeline, including potential corrective measures if plans and any milestones are not met.

Describe how program activities will foster the career development of clinician scientists and develop the working knowledge needed for scholars to select among and prepare for the next step in research career options available in the biomedical, behavioral and social science research workforce. Consider team science-based research approaches, depending upon the goals of the proposed DSPP.

Program Evaluation.

Describe a plan to review and evaluate the quality and effectiveness of the DSPP and the specialty training and PhD research career development components of the program. This plan should include the metrics to be evaluated, including program activities completed, certificate and/or completion of masters and PhD degrees, publications, fellowships/honors, and subsequent positions and career activities of DSPP trainees, as well as plans to obtain feedback from current and former scholars to help identify weaknesses and to provide suggestions for program improvements.

Institutional Environment and Commitment to the Program.

The sponsoring institution must assure support for the proposed K12 program including assurance that sufficient time will be allowed for the PDs/PIs and other Program Faculty to contribute to the proposed program, and that there will be protected time for scholars appointed to the K12 that matches the structure and phasing of the proposed DSPP.

Appropriate institutional commitment to the program includes the provision of adequate staff, facilities, and educational resources that can contribute to the planned program. This commitment may include features such as PD/PI salary, salary or tuition support for individuals involved in the DSPP, or other commitments essential to a successful career development program. Plans and a description of commitment to support DSPP scholars if continued K12 funding from NIDCR is not available must be included.

Plan for Instruction in the Responsible Conduct of Research

Individuals are required to comply with the instructions for Plan for Instruction in the Responsible Conduct of Research as provided in the SF424 (R&R) Application Guide.

Faculty, Scholars, and Training Record Section

Program Faculty

Provide information about the program faculty who will serve as mentors for the dental specialty training and for the PhD research training components of the DSPP, and who can provide guidance and expertise appropriate to the experiences of the DSPP scholars intended to be supported by the K12. Describe mentor training programs or other resources for mentor development that are available to program faculty to ensure effective mentoring experiences.

Each scholar must have two mentors, one mentor with expertise in the scholar’s dental specialty training and a primary mentor for research career development, who will work together to provide mentored supervision and support of the integrated specialty training and research training. These mentors must be supportive of the scholar's activities and progress in achieving the goals of the DSPP. Additional mentors are optional. The process of selecting mentors, assessing the mentoring relationships with the scholars and among program faculty, and mediating any challenges should be provided.

If a mentor will supervise a scholar proposing to gain research experience in a clinical trial, provide documentation of his/her expertise, experience, and ability to provide appropriate guidance and help the scholar to meet the study timelines.

Scholar Candidates

Describe the size and qualifications of the pool of potential DSPP scholars, including information about their prior clinical and research training experiences. Describe the nomination and selection process for scholars who will be offered admission to the program and appointed to the K12. Include criteria for scholar's evaluation and reappointment to the program. Present any novel strategies for recruiting qualified dentist scholars.

Participating Faculty Biosketches: Highlight the relevant experiences of the proposed program faculty according their role(s) and participation in the DSPP.

Letters of Support: Include letters of support from participating dental specialty program directors, graduate schools, departments or organizations involved in the DSPP, and any Senior/Key Persons. If the applicant institution has negotiated non-federal support from other partner organizations to support clinicians during the dental specialty training phase of the DSPP, letters describing this commitment must be provided.

Data Tables

Particular attention must be given to the required Training Data Tables: Tables 2, 4, and 8C.

Appendix

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

DO NOT USE. Attempts to submit a full, detailed study record will result in a validation error.

Delayed Onset Study

If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must complete a Delayed Onset Study.

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

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

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

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

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

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

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 and responsiveness by NIDCR, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

In order to expedite review, applicants are requested to notify the NIDCR Chief of the Scientific Review Branch 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 the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.

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.

For this particular announcement, note the following: Reviewers will provide an overall impact score to reflect their assessment of the likelihood that the proposed career development program will prepare individuals for successful, productive dental, oral and craniofacial research careers as dentist scientists with both clinical and research competencies, and thereby exert a sustained influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Reviewers will provide an overall impact score to reflect their assessment of the likelihood that the proposed training program will prepare individuals for successful, productive scientific research careers and thereby exert a sustained influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Reviewers will consider each of the review criteria below in the determination of the merit of the training program, and give a separate score for each. When applicable, the reviewers will consider relevant questions in the context of proposed short-term training. An application does not need to be strong in all categories to be judged likely to have major scientific impact.

Career Development Program and Environment

• Does the proposed program clearly outline a plan to recruit and develop well-qualified junior investigators for successful careers as biomedical or clinical researchers?
• Is there evidence of an adequate pool of potential scholars who could benefit from receiving career development support?
• Are the content and duration of any proposed didactic, training-related, and research-related activities of the program appropriate?
• Are appropriate timelines indicated for career progression and transition to independence?
• Does the institutional environment (e.g., research facilities and other relevant resources) in which the program will be conducted contribute to the probability of success?
• Does the proposed career development program benefit from unique features of the scientific environment, subject populations, or employ useful collaborative arrangements?
• Is the institutional commitment to the proposed program appropriate?
• If multiple sites are participating, is this adequately justified in terms of the career development and research experiences provided?
• Is there sufficient assurance that the required effort of the PD(s)/PI(s), mentors and scholars will be devoted directly to the research training, career development, and related activities?
• When applicable, is there adequate documentation describing the responsibilities of the advisory committee with regards to the provision of input, guidance and oversight of the proposed Career Development Program?
• Are the plans for identifying and recruiting dentists likely to ensure the selection and matriculation of qualified individuals who are committed to completing the DSPP and pursuing independent research careers?
• Does the structure and content of the DSPP incorporate the unique research development and clinical specialty training needs of DSPP scholars that will enable these individuals to complete the dental specialty and PhD research programs with requisite competencies in both areas?
• Are plans for monitoring scholars' progress and meeting milestones in the DSPP likely to ensure timely and successful completion of the program? Are corrective measures included if progress or milestones are not met?
• Is the proposed DSPP likely to ensure scholars will be well prepared for academic research careers?
• Are the program's career development activities likely to enhance the scholars' ability to compete successfully for individual NIH career development awards or other independent research support?
• Is the proposed overall evaluation of the program likely to provide informative metrics and feedback on the institution's DSPP and identify specific strengths and areas to enhance the program?

Program Director(s)/Principal Investigator(s) (PD(s)/PI(s))

• Do the PD(s)/PI(s) and Research Administrator (if applicable) have the experience to develop, direct and administer the proposed program?
• Does the leadership team bring complementary and integrated expertise to the program? Is there evidence that an appropriate level of effort will be devoted by the program leadership to ensure program objectives?
• Are the research qualifications, scientific stature, previous leadership and mentoring experience, and track record(s) appropriate for the proposed career development program?
• Are the PD(s)/PI(s) currently engaged in research relevant to the scientific area of the proposed program?

For applications designating multiple PDs/PIs:

• Is a strong justification provided that the multiple PD/PI leadership approach will benefit the career development program and the scholars?
• Is a strong and compelling leadership approach evident, including the designated roles and responsibilities, governance, and organizational structure consistent with and justified by the aims of the career development program and the complementary expertise of the PDs/PIs?

Mentors

• Do the mentors have appropriate expertise and experience, as well as track records of past successful mentoring and training PhD graduate students or dentists pursuing specialty training?
• Are the quality and extent of the mentors roles in providing guidance and scientific advice and career development to the scholars acceptable?
• Do the clinical mentors have relevant experience as directors of dental specialty programs or as participating faculty of dental specialty programs?
• To what extent are the mentors currently engaged in dental, oral and craniofacial research.?
• Are appropriate plans in place to ensure effective co-mentoring, and mediation if necessary, to ensure a scholar's successful and timely completion of the DSPP?
• If a Schoar is proposing to gain experience in a clinical trial as part of his or her research career development, is there evidence of the appropriate expertise, experience, and ability on the part of the mentor(s) to guide the Scholar during participation in the clinical trial?

Scholars

• Is a recruitment plan proposed with strategies likely to attract high quality scholars?
• Are there well-defined and well justified recruitment and selection strategies?
• Is there evidence of a sufficiently large, competitive scholar pool to warrant the proposed size of the career development program?
• Are the content, phasing, and proposed duration of the career development plan appropriate for achieving scientific independence of the scholars?
• What is the likelihood that the career development plan will contribute significantly to the scientific development of the scholars?

Training Record

• Is there evidence of a successful past training record of the PD/PI and mentors, including the success of former scholars in seeking independent research support and establishing productive scientific careers?
• Does the program have a rigorous evaluation plan to assess the quality and effectiveness of the proposed K12 career development program and objectives?

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

Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.

Inclusion of Women, Minorities, and Children

Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.

Vertebrate Animals

Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.

Biohazards

Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.

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

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.

Recruitment Plan to Enhance Diversity

Peer reviewers will separately evaluate the recruitment plan to enhance diversity after the overall score has been determined. Reviewers will examine the strategies to be used in the recruitment of individuals from underrepresented groups. The plan will be rated as ACCEPTABLE or UNACCEPTABLE, and the consensus of the review committee will be included in an administrative note in the summary statement.

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 specific characteristics of the career development program, the level of scholar experience, and the particular circumstances of the scholars, the reviewers will evaluate the adequacy of the proposed RCR training in relation to the following five required components: 1) Format - Does the plan satisfactorily address the format of instruction, e.g. lectures, coursework and/or real-time discussion groups, including face-to-face interaction? (A plan involving only on-line instruction is not acceptable.); 2) Subject Matter Does the plan include a sufficiently broad selection of subject matter, such as conflict of interest, authorship, data management, human subjects and animal use, laboratory safety, research misconduct, research ethics? 3) Faculty Participation - Does the plan adequately describe how faculty will participate in the instruction? 4) Duration of Instruction - Does the plan meet the minimum requirements for RCR, i.e., at least eight contact hours of instruction? 5) Frequency of Instruction Does the plan meet the minimum requirements for RCR, i.e., at least once during each career stage (undergraduate, post-baccalaureate, predoctoral, postdoctoral, and faculty levels) and at a frequency of no less than 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.

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).

Budget and Period of Support

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

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), 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.

Appeals of initial peer review will not be accepted for applications submitted response to this FOA.

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. 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.

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 http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.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 http://www.hhs.gov/ocr/civilrights/understanding/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 http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.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.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.

Not Applicable

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually. Continuation support will not be provided until the required forms are submitted and accepted.

Failure by the grantee institution to submit required forms in a timely, complete, and accurate manner may result in an expenditure disallowance or a delay in any continuation funding for the award.

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.

• The institution must submit a completed Statement of Appointment (PHS Form 2271) for each scholar appointed or reappointed to the K12 for 8 weeks or more. Grantees must submit the PHS 2271 data electronically using the xTrain system. More information on xTrain is available at xTrain (eRA Commons). An appointment or reappointment may begin any time during the budget period, but not before the budget period start date of the grant year.
• A notarized statement verifying possession of permanent residency documentation must be submitted with the Statement of Appointment (PHS Form 2271). Individuals with a Conditional Permanent Resident status must first meet full (non-conditional) Permanent Residency requirements before receiving support.
• Termination Notice: Within 30 days of the end of the total support period, the institution must submit a Termination Notice (PHS Form 416-7) via xTrain for each scholar appointed for eight weeks or more.

A final RPPR, 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. Evaluation results should be included as part of the final RPPR.

In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 Award Term and Conditions for Recipient Integrity and Performance Matters.

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 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)
Finding Help Online: http://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, Ph.D.
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-594-5006
Email: [email protected]

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

Diana Rutberg, M.B.A.
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 75.