Section III. Eligibility Information

1. Eligible Applicants

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.

The applicant institution must offer accredited dental specialty educational programs recognized by the National Commission on Recognition of Dental Specialties and Certifying Boards of the American Dental Association.

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) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.

• NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.

• eRA Commons - Applicants must have an active DUNS number to register in eRA Commons. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration, but all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

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

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

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research career development program as the Program Director/Principal Investigator (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 is expected to be an established and active investigator in a dental, oral, and craniofacial research scientific area, have experience in the research career development and mentoring of postdoctoral dentists, and should be capable of providing both administrative and scientific leadership to the development and implementation of the proposed DSPP. 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. The PD/PI will be responsible for the selection and appointment of scholars to the approved research career development program, and for the overall direction, management, administration, and evaluation of the program. The PD/PI will be expected to monitor and assess the program and submit all documents and reports as required. The PD/PI has responsibility for the day to day administration of the program and is responsible for appointing members of the Advisory Committee (if applicable), using their recommendations to ensure the program is meeting the goals of the DSPP.

Multiple PD(s)/PI(s) (MPIs) are encouraged, especially when each brings a unique perspective and skill set that will enhance the career development program, 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 participating dental specialty program. 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 MPI application must be an established investigator and have active peer-reviewed research support (PHS or non-PHS) over $100,000 direct costs per year at the time of application and be expected to have ongoing peer-reviewed research funding. One of the PD(s)/PI(s) must serve as the contact PD/PI with responsibilities for the day to day administration of the program.

2. Cost Sharing

3. Additional Information on Eligibility

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The NIH will not accept duplicate or highly overlapping applications under review at the same time, per 2.3.7.4 Submission of Resubmission. 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 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

Only one application in response to this RFA per institution (normally identified by having a unique DUNS number or NIH IPF number) is allowed.

Programs are encouraged to build a diverse team of mentors for the DSPP that includes, for example, faculty from underrepresented groups, including women (see Notice of NIH's Interest in Diversity), sexual and gender minorities, and faculty at different career stages (i.e., early-career as well as established faculty). Program faculty are expected to have mentoring experiences and a record of successful, former trainees who have established productive careers relevant to the NIDCR mission. Each scholar should have a mentor for the dental specialty training and a primary mentor for the PhD research training. Additional co-mentors are encouraged, if applicable, to a scholar’s individual DSPP. Mentors are expected to make available their expertise, guidance, and laboratory facilities and resources to support the scholars and their PhD dissertation research projects. All mentors must be committed to working as a team to ensure each scholar's success in completing the DSPP. Mentors for the dental specialty programs must be directly involved in the proposed training, either as a program director or faculty member. Mentors are expected to have the experience and expertise to develop postgraduate students advanced knowledge and skills for competency in the specialty practice, and to develop future leaders in clinical aspects of the specialty and research. The PhD research mentors are expected to be active investigators in dental, oral, and craniofacial research, and have a successful record of mentoring doctoral students. Evidence of successful mentoring includes former students research productivity, such as peer reviewed publications and patents, transition to research intensive or research related positions, and their success in obtaining independent peer reviewed research funding. Proposed mentors are expected to have independent NIH research funding (e.g., R01, R21) or equivalent at the time of the K12 award.

Scholars

Scholars to be supported by the institutional career development program must be at the career level for which the planned program is intended. NIH encourages appointment of individuals from diverse backgrounds including, for example, individuals from groups that are underrepresented in the biomedical, clinical, behavioral and social sciences, such as racial and ethnic groups, individuals with disabilities, and women (see Notice of NIH's Interest in Diversity), and sexual and gender minorities. 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’s appointment is acceptable. Dentists who have completed a PhD or equivalent research degree are not eligible. Scholars who have completed an accredited dental specialty program recognized by the National Commission on Recognition of Dental Specialties and Certifying Boards of the American Dental Association are not eligible.

Candidates may not have had a previous, or have pending, a mentored career development award, including institutional mentored career development support. Current and former 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. 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 training leading to a PhD and postdoctoral research experiences under mentored 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 an individual K award remain eligible for the NIDCR Dual Degree Dentist Scientist Pathway to Independence Award (K99/R00). 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 must be selected with the anticipated ability to complete the proposed DSPP program.

Potential scholars are encouraged to contact NIDCR for further information about DSPP programs.

Section IV. Application and Submission Information

1. Requesting an Application Package

The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the Training (T) Instructions in the SF424 (R&R) Application Guide except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

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: yasaman.shirazi@nih.gov

Page Limitations

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

Instructions for Application Submission

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

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424 (R&R) Other Project Information

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

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 career development program, as well as key activities in the career development plan. Indicate the planned duration of appointments, the projected number of scholars including their levels (i.e., postdoctoral), and intended scholar outcomes

Other Attachments. An Advisory Committee is not a required component of a training program. However, if an Advisory Committee is intended, provide a plan for the appointment of an Advisory Committee to monitor progress of the training 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. Renewal applications with Advisory Committees should include the names of all committee members during the past project period. Please name your file Advisory_Committee.pdf .

Sustainability Plan (required, 1-page maximum).

1. The application must provide a plan for supporting scholars whose appointments will be on-going at the end of a K12 DSPP project period. In addition, plans for sustaining support for scholars must be provided if a Renewal application is not competitive for funding.
2. Renewal applications must also include contingency plans for supporting current scholars through the completion of their DSPP activities beyond the funding period.
3. If a sustainablity plan attachment is not included, the application will be considered incomplete and will not be reviewed.
4. Please name your file Sustainability_Plan.pdf (without quotation marks).

Coordination and Interaction Plan (required, 1-page maximum).

1. Provide a clear and agreed upon governance statement for the proposed DSPP ensuring scholars will have protected time for an agreed upon schedule of advanced clinical and PhD graduate research activities over the duration of the scholar’s DSPP.
2. Include planned or anticipated coordination and integration of activities to form a cohesive DSPP program for the scholars. Additionally, a process for potential mediation or dispute resolution between clinical faculty and PhD graduate research mentors, independent of the DSPP scholar, should be described.
3. Please name your file Coordination_Plan.pdf (without quotation marks).

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

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

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

PHS 398 Cover Page Supplement

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

PHS 398 Training Subaward Budget Attachment(s)

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

Research and Related (R&R) Budget

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.

PHS 398 Research Training Program Plan

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 or if the FOA specifically instructs applicants to do so.

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

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.

For this FOA, applicants should use the following Data Tables only (Data for scholars should be entered into the Postdoctoral sections of the Data Tables):

Table 2 (New and Renewal applications)
Table 3 (New and Renewal applications)
Table 4 (New and Renewal applications)
Table 8C Part I for Renewal applications
Table 8C Part III Recent Graduates for NEW applications
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, permanent residents and non-citizens).

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/PI. If multiple PDs/PIs are proposed, describe their complementary leadership and expertise in administering the program, and relate these strengths to the proposed management of the 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.

Provide evidence of the ability of the institution to establish and 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.

Institutions with existing research training or career development programs must explain what distinguishes this K12 program from the others institutional training programs, 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 DSPP.

If a program administrator position is planned, describe the scientific expertise, leadership, and administrative capabilities essential to coordinate a program for developing dentist scientists.

Program Faculty

Provide information about the program faculty who will serve as supervisors and/or mentors for the dental specialty training and for the PhD research training components of the DSPP. Describe their experience and expertise appropriate for the training and development of the 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, at a minimum, two mentors who will work together to provide mentored supervision and support of the integrated specialty training and research training. One mentor must have expertise in the scholar’s dental specialty program, and one must be the primary mentor for the scholar’s dissertation research. The mentors must be supportive of the scholar's activities and progress in achieving the goals of the DSPP. Additional mentors are optional. Describe the process of selecting mentors, of assessing the mentoring relationships with the scholars and among program faculty and mediating any challenges should be provided.

Provide information on the extent the clinical and research faculty have cooperated, interacted, and collaborated in the past, including joint publications and joint sponsorship or mentorship of student and/or postdoctoral research.

Proposed Career Development Program.

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

Clearly identify the PhD research phase supported by the K12, including the minimum of 3 years at a minimum of 9 person months (75% full time professional effort) to a maximum of 5 consecutive years of support. Identify if the program will use the additional flexibility in research effort at a minimum of 6 person months (50% full time professional effort) for 1 or 2 year if scholars are appointed to the K12 for 4 or 5 years, respectively.

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.

Describe how the DSPP will be individually tailored to meet the unique research and clinical development needs of each scholar in terms of content and phasing of the scholar's DSPP, and in the selection of mentors for the clinical dental education and the graduate research training. Describe how a scholar’s clinical and research training will form a cohesive program, i.e., how the clinical training will be integrated with, augment, or complement the scholar's graduate research project and future research directions.

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. Describe how the DSPP will provide a foundation for clinically relevant dental, oral, and craniofacial research. Team science-based research approaches should be considered, depending on the goals of the proposed 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.

Program Evaluation

Provide a plan to review and evaluate the quality and effectiveness of the DSPP, including the specialty training and PhD research career development components of the program. The plan should include evaluation metrics, including program activities completed, such as a certificate and/or completion of masters or other degree associated with the dental specialty training, in addition to a PhD or equivalent degrees, publications, other research products, fellowships/honors, and subsequent positions and career activities of DSPP trainees. Include plans to obtain feedback from current and former scholars to help identify weaknesses in the proposed DSPP 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.

Scholar Candidates

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.

Institutional Environment and Commitment to the Program

Document support for the clinical dental specialty and the PhD research components of the DSPP and ensure scholars complete the DSPP program with requisite competencies in both components. The sponsoring institution must demonstrate commitment that sufficient time will be allowed for the PDs/PIs and other Program Faculty to contribute to the proposed program, and that the scholars will have protected time for DSPP activities that matches the structure and phasing of the proposed program. Institutions are encouraged to rigorously enforce this protected time.

?????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.

Particular attention must be given to the required Training Data Tables: Tables 2, 3, 4, and 8C.

Program Faculty.

If any mentors will supervise a Scholar proposing to gain research experience in a clinical trial, provide documentation of his/her expertise, experience, and ability to provide guidance in the organization, management and implementation of the proposed clinical trial, ancillary, or feasibility study and help him/her to meet the study timelines.

.

Appendix:

Limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to theSF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information

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

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).

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.

PHS Assignment Request Form

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

3. Unique Entity Identifier and System for Award Management (SAM)

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

4. Submission Dates and Times

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

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

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

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

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The National Research Service Award (NRSA) policies apply to this program. An NRSA appointment may not be held concurrently with another Federally sponsored fellowship, traineeship, or similar Federal award that provides a stipend or otherwise duplicates provisions of the NRSA.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement. Note, however, that pre-award costs are not allowable charges for stipends or tuition/fees on institutional training grants because these costs may not be charged to the grant until a trainee has actually been appointed and the appropriate paperwork submitted to the NIH awarding component. Any additional costs associated with the decision to allow research elective credit for short-term research training are not allowable charges on an institutional training grant.

7. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

All PD(s)/PI(s) 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 components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in the policy . Any instructions provided here are in addition to the instructions in the policy.

Section V. Application Review Information

Only the review criteria described below will be considered in the review process.

Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

For this particular announcement, note the following:, t. Reviewers should evaluate the likelihood the proposed career development program will prepare dentist scientists with both clinical and research competencies that will provide a foundation for successful, productive, and independent dental, oral, and craniofacial research careers.

Overall Impact

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? Do the program activities foster the development of skill and expertise in transparent, rigorous, and reproducible research methodologies, including relevant areas of data science?
• 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/PI, 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 regard to the provision of input, guidance and oversight of the 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?
• Do 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/PI 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 mentoring and training?
• Are the quality and extent of the mentors roles in providing guidance and scientific advice to the scholars acceptable? Are the mentors currently engaged in relevant research?

• If the program will support clinical trial research experience for the Trainees, do the mentor(s) who will supervise the Trainee(s) have the expertise, experience, resources, and ability to provide appropriate guidance and help the Trainee(s) to meet the timelines?

• 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?

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?
• Does the plan for selection of the scholars include all of the eligibility criteria stated in the FOA?

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 support and establishing productive scientific careers?

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 Individuals Across the Lifespan

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.

Career Development in Methods for Enhancing Reproducibility

Does the plan for Instruction in Methods for Enhancing Reproducibility describe how the program will provide career development in scientific reasoning, rigorous research design, relevant experimental methods, consideration of relevant biological variables such as sex, authentication of key biological and/or chemical resources, quantitative approaches, and data analysis and interpretation, appropriate to field of study and the level and prior preparation of the scholars?

Resubmissions

Not Applicable

Renewals

For Renewals, the committee will consider the progress made in the last funding period, including on the Recruitment Plan to Enhance Diversity, and Training in the Responsible Conduct of Research. Does the application describe the program’s accomplishments over the past funding period(s)? Are changes proposed that would improve or strengthen the career development experience? Is there evidence of a successful past training record of the PD/PI and mentors, including the success of former scholars in seeking independent support and establishing productive scientific research careers?

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 prospective 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 career development 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? For renewal applications, are all career development faculty who served as course directors, speakers, lecturers, and/or discussion leaders during the past project period named in the application? 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?

For renewal applications, does the progress report document acceptable RCR instruction in the five components described above? Does the plan describe how participation in RCR instruction is being monitored? Are appropriate changes in the plan for RCR instruction proposed in response to feedback and in response to evolving issues related to responsible conduct of research?

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 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 will receive a written critique.

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.

Appeals for initial peer review will not be accepted for applications submitted in 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.

• 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.

Section VI. Award Administration Information

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 recipient’s business official.

Recipients must comply with any funding restrictions described in Section IV.6. 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, Recipients, and Activities, including of note, but not limited to:

• Federalwide Research Terms and Conditions
• Prohibition on Certain Telecommunications and Video Surveillance Services or Equipment
• Acknowledgment of Federal Funding

If a recipient is successful and receives a Notice of Award, in accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex. This includes ensuring programs are accessible to persons with limited English proficiency. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html.

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.

• Recipients of FFA must ensure that their programs are accessible to persons with limited English proficiency. HHS provides 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/fact-sheet-guidance/index.html and https://www.lep.gov. 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 https://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.
• 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.
• HHS funded health and education programs must be administered in an environment free of sexual harassment. Please see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html; https://www2.ed.gov/about/offices/list/ocr/docs/shguide.html; and https://www.eeoc.gov/eeoc/publications/upload/fs-sex.pdf. For information about NIH's commitment to supporting a safe and respectful work environment, who to contact with questions or concerns, and what NIH's expectations are for institutions and the individuals supported on NIH-funded awards, please see https://grants.nih.gov/grants/policy/harassment.htm.
• Recipients of FFA must also administer their programs in compliance with applicable federal religious nondiscrimination laws and applicable federal conscience protection and associated anti-discrimination laws. Collectively, these laws prohibit exclusion, adverse treatment, coercion, or other discrimination against persons or entities on the basis of their consciences, religious beliefs, or moral convictions. Please see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/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.

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 and 2 CFR Part 200.206 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, recipients 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 recipient 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.

For Research Performance Progress Reports (RPPRs), follow the instructions in section 7.4 Training RPPRs and include the following additional information:

B.4 What opportunities for training and professional development has the project provided?

• Provide information about the scholars (name, degrees), and their primary clinical and research mentors (names, degrees, clinical or research area of expertise).
• Clearly identify activities associated with the dental specialty vs the research training.
• Describe the scholar’s clinical activities (including any research associated with the dental specialty training) and the scholar’s research project and progress
• Provide updated information in Table 8C, reflecting new appointments and other changes over the reporting period

The institution must submit a completed Statement of Appointment (PHS Form 2271) for each scholar appointed or reappointed to the institutional career development award for 8 weeks or more. Recipients 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.

• 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 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.

Section VII. Agency Contacts

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, application errors and warnings, documenting system problems that threaten on-time submission, and post-submission issues)

Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application processes and NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-480-7075

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov

Anissa J. Brown, PhD
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-594-4805
Email: anissa.brown@nih.gov

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

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

Section VIII. Other Information

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 and 2 CFR Part 200.