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 Ruth L. Kirschstein National Research Service Award (NRSA) program is to help ensure that a diverse pool of highly trained scientists is available in appropriate scientific disciplines to address the Nation's biomedical, behavioral, and clinical research needs. In order to accomplish this goal, NRSA training programs are designed to train individuals to conduct research and to prepare for research careers. More information about NRSA programs may be found at the Ruth L. Kirschstein National Research Service Award (NRSA) website.

Purpose and Background Information

The NRSA program has been the primary means of supporting predoctoral and postdoctoral research training programs since enactment of the NRSA legislation in 1974. Research training activities can be in basic biomedical or clinical sciences, in behavioral or social sciences, in health services research, or in any other discipline relevant to the NIH mission.

Institutional NRSA programs allow the Training Program Director/Principal Investigator (Training PD/PI) to select the trainees and develop a program of coursework, research experiences, and technical and/or professional skills development appropriate for the selected trainees. Each program should provide high-quality research training and offer opportunities in addition to conducting mentored research. The grant offsets the cost of stipends, tuition and fees, and training related expenses, including health insurance, for the appointed trainees in accordance

with agency-approved support levels.

The objective of the NIDCR Ruth L. Kirschstein National Research Service Award (NRSA) Institutional Research Training Grant (T32) program is to develop and/or enhance the research workforce pipeline dedicated to improving dental, oral and craniofacial health by providing research training opportunities in topics that align with the NIDCR mission and Strategic Plan.

It is expected that the NIDCR training program will provide:

• A strong foundation in the principles of research rigor and reproducibility including research design, methodology, statistical approaches, and analytic techniques appropriate for the proposed research area;
• The enhancement of the trainees ability to conceptualize, think through, and address research problems with increasing independence;
• Experiences conducting research using state-of-the-art methods and approaches including advancements in data science, such as machine learning and artificial intelligence (AI);
• Experiences conducting or furthering research on, or awareness of, new and emerging research tools and technologies, e.g., advanced imaging, cryoelectron microscopy, etc.;
• Trainee experiences in presenting research to a wide range of audiences, and publishing their research findings as lead author;
• Opportunities for trainees to interact with diverse members of the scientific community at relevant scientific meetings and workshops;
• The enhancement of the trainees understanding of the health-related sciences and the relationship of their research to dental, oral and craniofacial health and disease;

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

The duration of training, the transition of trainees to individual support mechanisms, and their transition to the next career stage are important considerations in institutional training programs. Training PDs/PIs should limit appointments to individuals who are committed to a research career and who plan to remain in training for no less than two years, whether that support comes from a training grant or some combination of NRSA and non-NRSA support programs. Past studies have shown that health professionals who train in programs with postdoctoral researchers who have intensive research backgrounds are more likely to apply for and receive subsequent research grant support. Therefore, programs that emphasize research training for individuals with the D.D.S., D.M.D., M.D. or other health-professional degrees are encouraged to develop ties to basic science departments and include trainees with research doctorates when this approach is consistent with the goals of the proposed training program.

Institutional research training grants must be used to support a program of full-time research training. Within the full-time training period, research trainees who are also training as clinicians must devote their time to the proposed research training and must confine clinical duties to those that are an integral part of the research training experience. The program may not be used to support studies leading to the D.D.S., D.M.D. or other clinical, health-professional training except when those studies are part of a formal combined research degree program, such as the D.D.S./D.M.D.-Ph.D. Similarly, trainees may not accept NRSA support for clinical training that is part of residency training leading to clinical certification in a dental or medical specialty or subspecialty. It is permissible and encouraged, however, for clinicians to engage in NRSA-supported, full-time postdoctoral research training even when that experience is creditable toward certification by a clinical specialty or subspecialty board.

Trainees will not be limited to a predetermined maximum number of years on the training grant, other than the years of support specified by NRSA policy. However, it is expected that all trainees will submit applications for their own independent grant support from NIH, such as an individual fellowship (F) award, career development (K) or career transition (K99/R00) award, or from other federal or non-federal agency or organization (e.g., professional society or foundation). Applications for individual support are expected to be submitted after the trainee has selected a lab, a sponsor or mentor, and a research project. NIDCR will consider a waiver of NRSA policy regarding years of support for a trainee only if provided with evidence of the submission of the trainee's application for independent funding. Programs are expected to include training in grant-writing to prepare trainees to apply for independent support, as well as training in other research career activities such as delivering oral presentations and publishing research findings.

Within the framework of the NRSA program’s longstanding commitment to excellence and the projected need for investigators in particular areas of research, attention must be given to recruiting trainees and involving mentors from racial and ethnic groups underrepresented in the biomedical, behavioral and clinical sciences, and individuals with disabilities. See the Training (T) Instructions in the SF424 (R&R) Application Guide for further background and instructions.

NIDCR training programs are expected to implement robust plans and to be flexible in adopting new strategies to enhance diversity and to promote inclusive research environments (i.e., institutional and departmental environments in which trainees from all backgrounds feel integrated into and supported by the research community). Whereas institutional efforts are critical to creation of inclusive environments, including protections against harassment and discriminatory practices, training programs must also strive to create environments that effectively promote diversity and inclusion.

Training grants that will support both predoctoral students and postdoctoral fellows should have program activities in which both groups of trainees participate and interact. The program may include shared and different activities, but all activities must occur in the context of an integrated and collaborative program which benefits all trainees.

NIDCR encourages opportunities that provide interdisciplinary research training and programs that take advantage of clinical research opportunities within nationwide networks and infrastructures such as the NIH Clinical and Translational Science Award (CTSA) Program, as well as programs that value team science, transformative approaches, and diversity at all levels.

Applicant institutions may propose to cooperate or collaborate with other institution(s) and organization(s) in research training activities or in trainee recruitment activities to achieve the goals of their proposed programs.

The career outcomes of individuals supported by NRSA training programs include both research-intensive careers in academia and industry and research-related careers in various sectors, e.g., academic institutions, government agencies, for-profit businesses, and private foundations. Training programs should make available structured career development advising and learning opportunities (e.g., workshops, discussions, Individual Development Plans). Through such opportunities, trainees are expected to be aware of various potential career directions that make strong use of the knowledge and skills gained during research training, and the steps required to transition successfully to the next stage of their chosen career.

Scope of Training

The T32 programs can include one or a combination of any of the following predoctoral and postdoctoral training components:

• Dentist Scientist Training Program (DSTP) to support predoctoral trainees seeking to obtain both the D.D.S./D.M.D. and Ph.D. degrees in an integrated dual degree program. The goal of this component is to produce dentist-scientists who conduct clinically-relevant dental, oral or craniofacial health research;
• Predoctoral Ph.D. research training to support promising doctoral candidates seeking to pursue research careers in health-related fields relevant to the NIDCR mission;
• Postdoctoral training for individuals with a clinical doctoral degree or equivalent (D.D.S., D.M.D., B.D.S., M.D., PharmD, D.V.M.) who are seeking research training which may lead to a Ph.D. or equivalent research degree, a Masters in Clinical Research, or a Masters of Public Health degree;
• Postdoctoral training for individuals with a clinical doctoral degree and a Ph.D. or equivalent degree, and for non-clinician Ph.D. scientists. NIDCR encourages dental, oral, and craniofacial pathophysiology training for non-clinician Ph.D. scientists to provide an understanding of the clinical relevance of their research in improving oral health.

NOTE: The companion NIDCR T90/R90 Institutional Training Program FOA (PAR-20-NNN) includes an R90 education component to provide postdoctoral training for non-citizen dentists who do not meet the T32 or T90 NRSA eligibility requirements. An institution may not submit applications in response to both NIDCR Institutional Training announcements.

This Funding Opportunity Announcement (FOA) does not allow appointed Trainees to lead an independent clinical trial but does allow them to obtain research experience in a clinical trial led by a mentor or co-mentor. NIH strongly supports training towards a career in clinically relevant research and so gaining experience in clinical trials under the guidance of a mentor or co-mentor is encouraged.

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

Eligible applicant institutions include dental schools and other institutions that have strong and high-quality research programs in dental, oral or craniofacial research, and must have the requisite faculty, staff, potential trainees 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 trainees 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 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 investigator in a research area relevant to dental, oral or craniofacial science and 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 independent peer-reviewed research funding at the time of application and is expected to maintain such grant support during the project period.

The PD/PI will be responsible for the selection and appointment of trainees to the approved research training 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 (when applicable), using their recommendations to determine the appropriate allotment of funds.

For programs that propose to have multiple PDs/PIs, at least one should be an established

investigator in the scientific area in which the application is targeted, have active research funding, and be capable of providing both administrative and scientific leadership to the development and implementation of the proposed program. Additional PDs/PIs may be included to achieve the training goals. If multiple PD/PIs are proposed, they must be from different schools or departments in the applicant institution, they should have complementary expertise, and have the potential to enhance multidisciplinary/interdisciplinary research training opportunities. The multiple PD/PI leadership plan should address the selection of the PD/PIs and delineate the role of each PD/PI in achieving the training program goals.

In keeping with the effort to enhance the involvement of individuals from diverse backgrounds and perspectives in training, and in providing role models that bring diversity to a training environment, inclusion of women and/or individuals from diverse backgrounds when forming the leadership team of the training program is strongly encouraged.

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

Only one application in response to this FOA or the companion FOA PAR-20-NNN per institution (normally identified by having a unique DUNS number or NIH IPF number) is allowed.

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.

The selected faculty mentors should have active peer reviewed research funding and experience mentoring at the level in which they will be participating (e.g., mentoring dual degree students, PhD students, postdoctoral scientists). When building a training team, programs should include faculty who are committed to training, mentoring, and providing supportive, inclusive, and non-discriminatory research environments. Mentors should have research expertise and experience relevant to the proposed program and must be committed to continue their involvement throughout the total period of the award. PD(s)/PI(s) are encouraged to leverage mentors/co-mentors from other institutional programs (e.g., Clinical and Translational Science Awards, CTSA). Program should strive to build a diverse team of mentors that includes, for example, faculty from underrepresented groups (NIH's Interest in Diversity), women, and faculty at different career stages (i.e., junior as well as senior faculty). Programs that include junior faculty with limited experience as primary mentors should ensure that an oversight mechanism in place, such as mentor training for junior faculty, and/or a co-mentoring arrangement with an experienced mentor, to ensure that each trainee receives thoughtful and outstanding mentorship and guidance. Each mentor should be committed to the goals and objectives of the NIDCR T32 and the proposed Institutional program.

The individual to be trained must be a citizen or a noncitizen national of the United States or have been lawfully admitted for permanent residence at the time of appointment. Additional details on citizenship, training period, and aggregate duration of support are available in the NIH Grants Policy Statement.

Dual degree predoctoral trainees must have received a baccalaureate degree by the beginning date of their NRSA appointment and must be enrolled in a combined D.D.S. or D.M.D. degree and Ph.D. degree from accredited programs.

Predoctoral trainees must be enrolled in a program leading to a Ph.D. or in an equivalent research doctoral degree program. Health-professional students who wish to interrupt their studies for one year or more to engage in full-time research training before completing their formal training programs, are also eligible.

Postdoctoral trainees must have received, as of the beginning date of the NRSA appointment, a Ph.D., D.D.S., D.M.D., M.D., or comparable doctoral degree from an accredited domestic or foreign institution. Comparable doctoral degrees include, but are not limited to, the following: D.C., D.O., D.V.M., O.D., D.P.M., Sc.D., Eng.D., Dr.PH., D.N.Sc., D.P.T., Pharm.D., N.D. (Doctor of Naturopathy), D.S.W., Psy.D., as well as a doctoral degree in nursing research. Documentation by an authorized official of the degree-granting institution certifying all degree requirements have been met prior to the beginning date of the training appointment is acceptable.

Eligible postdoctoral trainees include individuals with a dual health professional doctoral degree (e.g., D.D.S., D.M.D., M.D.) and a Ph.D. and individuals with a health professional doctoral degree (e.g., D.D.S., D.M.D.) who may or may not be pursuing a Ph.D. degree or earning master's degree. Individuals in postgraduate clinical training, who wish to interrupt their studies for one year or more to engage in full-time research training before completing their formal training programs, are also eligible.

Additional information on postdoctoral eligibility: postdoctoral trainees are expected to be individuals who have received a doctoral degree (or equivalent) and are engaged in a temporary and defined period of mentored advanced training to enhance the professional skills and research independence needed to pursue his or her chosen career path. (See the NIH-NSF Definition of a Postdoctoral Scholar. (PDF - 85 KB)).

All trainees are required to pursue their research training full time, normally defined as 40 hours per week, or as specified by the sponsoring institution in accordance with its own policies. Appointments are normally made in 12-month increments, and no trainee may be appointed for less than 9 months during the initial period of appointment, except with prior approval of the awarding unit.

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.

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, Ph.D.
Telephone: 301-594-5593
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:

Project Summary/Abstract. Provide an abstract of the entire application. Include the objectives, rationale and design of the research training program, as well as key activities in the training plan. Indicate the planned duration of appointments, the projected number of trainees including their levels (i.e., predoctoral dual degree D.D.S./D.M.D.-Ph.D., predoctoral Ph.D., and postdoctoral trainees), and intended trainee 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 .

Training Plan Letter: If a collaborating institution is involved, written commitment to the training plan signed by the collaborating site PD/PI, and countersigned by the site signing official, must be part of the application. Name the PDF formatted letter "Training_Plan_Ltr.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

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

• Include all personnel other than the Training PD(s)/PI(s) in the Other Personnel section, including clerical and administrative staff.
• Training programs may request a maximum of 10 training slots in any combination of dual degree predoctoral, PhD predoctoral and postdoctoral training slots. The number of slots and the proposed training categories must be strongly supported and justified in the application.

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

• Training Program
• Faculty, Trainees, and Training Record
• Other Training 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 with the following additional modifications:

Particular attention must be given to the required Training Data Tables and ensure the tables are complete and up to date with respect to a new or renewal application.

In the body of the application (PHS398 Research Training Program Plan), applicants should summarize key data from the tables that highlight the characteristics of the applicant pool, faculty mentors and their accomplishments and training records, the educational and career outcomes of participants, and other factors that contribute to the overall environment of the program. Applicants should ensure that summaries accurately reflect the data in the tables, as reviewers pay careful attention to both.

In addition to the instructions in the SF424 (R&R) application guide, include the following:

Program Plan

Program Administration

Describe the acknowledged strengths, leadership and administrative skills, training experience, scientific expertise, and active research of the PD(s)/PI(s). Relate these strengths to the proposed management of the training program. Describe the planned strategy and administrative structure to be used to oversee and monitor the program. If there are multiple PD(s)/PI(s), then the plan for Program Administration is expected to synergize with the Multiple PD/PI Leadership Plan section of the application, if applicable.

Describe how the level of institutional (or school/department) commitment to research and training excellence will promote the success of the trainees and training program.

If the applicant institution proposes to collaborate with another institution/organization in trainee recruitment or research training activities, arrangements must be completed before application submission. Clearly outline the arrangements between the participating institutions/organizations for the recruitment and joint selection of mentors and trainees for research training, and for ongoing cooperation and collaboration between the institutions/organizations in the implementation of the proposed program.

Program Faculty

The application must include information about the program faculty who will be available to serve as preceptors/mentors and provide guidance and expertise appropriate to the level of trainees proposed in the application. Describe the complementary expertise and experiences of the proposed Program Faculty, including active research and other scholarly activities in which the faculty are engaged, as well as experience mentoring and training individuals at the proposed career stage(s). If any proposed Program Faculty lack research training experience or have a modest training record, describe a plan to ensure successful trainee guidance by these individuals, e.g., through faculty training in mentorship, co-mentoring arrangements, or other plans to ensure high quality mentorship to all trainees.

Provide a narrative description of the past research training record of the program faculty including the success of former trainees in establishing productive independent research or research-related careers. Evidence of success can include completion of programs and further career advancement of former trainees, such as receipt of fellowships and/or career development awards, further predoctoral, postdoctoral or other training appointments; successful competition for research science positions in industry, academia, government or other research venues and similar accomplishments. Evidence of a productive scientific career can include a record of successful competition for research grants, receipt of honors, awards or patents, high-impact peer-reviewed publications, promotion to scientific leadership positions, and other measures of success that demonstrate scientific excellence and independence.

The application should include plans to provide training or workshops for program faculty on effective research career mentoring (at the career levels of proposed trainees) to ensure that all mentors in the training program have an opportunity to discuss mentoring challenges and solutions, and ultimately enhance the diversity and success of all trainees in the program in their pursuit of research careers.

Proposed Training

Provide an overview of the proposed program, describe the immediate and long-term objectives of the proposed program, and the program activities that will be used to meet these objectives. Provide rationale for the requested number and types of trainees (e.g., dual degree, predoctoral, postdoctoral). Demonstrate the presence of a sufficient number of potential trainees in appropriate disciplines and program faculty with the appropriate scientific expertise, as well as the resources to achieve the training objectives. Explain how the program's support for courses, seminars, workshops and other activities may benefit other students or postdoctoral scientists at the institution.

For renewal applications, highlight how the training program has evolved in response to changes in relevant scientific and technical knowledge, educational practices, and to past and ongoing evaluation of the training program.

Describe how trainees will be educated in the human health and disease-related aspects of their research training. Include information about planned courses, mentored research experiences, and any activities designed to develop specific technical or quantitative skills or other knowledge or skills essential for the proposed research training.

Describe how trainees appointed to the training program will have the opportunity to carry out state-of-the-art supervised biomedical or behavioral research with the primary objective of developing or extending their research skills and knowledge in preparation for a research career. Describe how the training plan will incorporate interdisciplinary research training, team science approaches, and new and emerging technologies, including data science approaches into the training plan or curricula.

Mentoring plans appropriate for the training and career level(s) of the trainees (e.g., dual degree, predoctoral, postdoctoral) should be described, including the nature of the supervision and mentoring that will occur during a trainee s participation in the program.

Describe program activities intended to develop the working knowledge needed for trainees to select among and prepare for the next step in career options available in the biomedical workforce. For example, programs should provide all trainees with instruction and training in oral and written presentation and in skills needed to apply for individual fellowships (F) career development awards (K), or research project grant (RPG) support. As part of the research training experience, this FOA requires that all trainees apply for independent research support from NIH, another federal agency (e.g., NSF), private foundation, professional society or other organization. This requirement is intended to provide experiences in formulating a research strategy, communicating science, receiving expert feedback on proposed research, and navigating the grant application process.

If providing research training at the postdoctoral level, describe plans to emphasize specialized training to meet national research priorities in the biomedical, behavioral, or clinical sciences that are within the NIDCR mission. Postdoctoral trainees should be provided with instruction in laboratory and project management and career skills necessary for transitions to academic research careers or similar positions.

Proposed DSTP Training

Applications that propose a dentist scientist training program (DSTP), i.e., predoctoral students seeking both a D.D.S./D.M.D. and PhD in an integrated program, must provide evidence that the applicant institution is able to provide programs tailored to meet the unique clinical development and research needs of each DSTP trainee, and ensure that the individuals complete the clinical and research programs with requisite competencies in both areas. Proposed DSTP programs are to include:

• A description and background on the institution's proposed DSTP.
• For renewal applications, include a description of program outcomes, such as the completion rate and the percentage of DSTP program graduates who are in academic research or research-related positions post-training. Highlight how the training program has evolved in response to changes in relevant scientific and technical knowledge or opportunities, educational practices, recruitment challenges, and to any past or ongoing evaluations of the training program.
• For new applications or renewal applications proposing new DSTP programs: include documentation of any recent history (within 10 years) of success in training dual degree dentist-scientists, a description of the quality and quantity of an anticipated applicant pool, and the rationale for the likelihood of success of the proposed new DSTP, highlighting unique features of the program.
• A description of the structure and timing of the dual degree program, including the percentage of time that will be devoted to clinical and research related activities each year of the program, required milestones, and the timing of meeting those milestones during the DSTP (e.g., completion of coursework, teaching and clinical requirements, qualifying exams).
• A description of any clinical tutorials during the graduate research years, a description of any research-associated activities during the clinical years of the dual degree program, and any activities to ease transition between graduate and clinical years of the dual degree program.
• A description of the anticipated funding over the duration of the DSTP and a description of the dental school's commitment to the program.

Training Program Evaluation

The application should describe an evaluation process to determine the effectiveness of the Program. The overall evaluation plan should include the metrics to be evaluated, e.g., program activities completed, degree completion (if applicable), publications, fellowships/honors, any awards, including NIH fellowships and awards, subsequent positions including further postdoctoral or clinical training, and plans to obtain feedback from current and former trainees to provide suggestions for program improvement. The program evaluation should include metrics for evaluating the program faculty and for monitoring and evaluating partnerships at the level of institutions, schools, departments and funded programs, such as other Institutional training grants or Clinical and Translational Science Awards. For programs that have an advisory committee, describe the committee's role in the Program evaluation and how it differs from the internal program evaluation.

Trainee Candidates

Through the narrative and summaries of the information presented in the Training Tables (https://grants.nih.gov/grants/forms/data-tables.htm) the following areas relevant to trainees should be addressed:

Describe the characteristics of the applicant pool, applicants eligible for support, new entrants into the program and new entrants eligible for support. Describe the ability of participating department(s) and/or the institution(s) to support trainees for the duration of their training. Describe the plans for a holistic candidate review process that will select a diverse group of trainees who have taken advantage of the research opportunities available to them and are committed to contributing to the biomedical research enterprise.

Define and justify the selection and re-appointment criteria for trainees in the training program. Describe the record of training individuals from diverse backgrounds, including those from groups that have been shown to be underrepresented in the biomedical, behavioral or clinical research workforce, such as underrepresented racial and ethnic groups and those with disabilities (see NOT-OD-18-210 https://grants.nih.gov/grants/guide/notice-files/NOT-OD-18-210.html).

For those institutions that have DSTP programs and intend to support D.D.S./D.M.D.-Ph.D. students with this funding opportunity, the PD/PI should explain the process by which D.D.S./D.M.D.-Ph.D. students will be selected for support (including the anticipated number of DSTP students supported) and how the proposed program will ensure the interaction of dual degree trainees with Ph.D. students and postdoctoral trainees.

Institutional Environment and Commitment to the Program

The application should describe how the level of institutional and departmental commitment to research and training excellence will promote the success of the trainees and training program. Assurances of institutional commitment should be provided in the Letters of Support section of the application.

Appropriate institutional commitment includes the provision of adequate staff, facilities, and resources that can contribute to the planned program. Institutions that propose DSTP programs must provide evidence of the institution's ability to establish or successfully implement an integrated training program for dual degree students, including; coordination among participating clinical, basic, and behavioral science departments within the dental, medical and other graduate schools. Plans and a description of commitment to support DSTP trainees in the event that a DSTP trainee has exceeded NRSA support limits and/or in the event that continued funding from NIDCR is not available must be included.

Institutional commitment to promote diversity and an inclusive research environment should be described, i.e., describe institutional and departmental environments in which trainees from all backgrounds are integrated into, and supported by, the institution, and how diverse faculty representation, including individuals from groups underrepresented in biomedical/behavioral research (NOT-OD-18-210), including women, junior faculty and experienced senior investigators, contribute to the proposed training program.

Applications must include a separate letter on institutional letterhead signed by a key institutional leader that describes the institutional commitment to ensuring that proper policies, procedures, and oversight are in place to prevent discriminatory harassment and other discriminatory practices as described in NOT-OD-19-029 (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-19-029.html).

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.

Plan for Instruction in Methods for Enhancing Reproducibility

Describe the programmatic activities designed to ensure that all trainees gain a thorough understanding of the principles of research reproducibility and how these principles will be integrated into the overall training plan, curricula, and individual trainee research projects. Topics should include, but are not limited to: evaluation of foundational research underlying a project (i.e., scientific premise, rigor of prior research) and rigor of experimental design, i.e., robust and unbiased experimental approaches, methods, analyses, data interpretation, data replication, and transparent reporting of results. Consideration should be given to relevant biological variables such as sex, authentication of key biological and/or chemical resources, data and material sharing, record keeping and transparency in reporting. Resources and tools for rigorous experimental design can be found at the Enhancing Reproducibility through Rigor and Transparency website.

Faculty, Trainees, and Training Record Section

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

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 the SF424 (R&R) Application Guide instructions.

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. 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.

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, NIH. Applications that are incomplete or non-compliant will not be reviewed.

In order to expedite review, applicants are requested to notify the NIDCR Review Chief 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.

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

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.

Training Program and Environment

• Are the research facilities and research environment conducive to preparing trainees for successful careers as biomedical research scientists who have an understanding of the relationship of their research to dental, oral and craniofacial health and disease?
• Are the objectives, design and direction of the proposed research training program likely to ensure effective training?
• Do the courses, where relevant, mentored research experiences and structured activities provide opportunities for trainees to acquire state-of-the-art scientific knowledge, research methods, and tools and technologies that are relevant to the goals of the training program?
• Does the program provide training in a diversity of research approaches such as team science and inter- or multidisciplinary research training opportunities, training in state-of-the-art approaches in data science, including machine learning and AI, and in new and emerging imaging tools and technologies, as appropriate for the proposed research training?
• Is the proposed training program likely to ensure individualized attention to each trainee's research experience and to ensure that all trainees will be well prepared for research-intensive and research-related careers?
• Does the program provide time and training in grant writing and ensure submission of applications for individual NIH fellowships, career development awards or other independent research training support?
• Does the institutional commitment ensure that proper policies, procedures, and oversight are in place to prevent discriminatory harassment and other discriminatory practices? Is the level of institutional commitment to the training program, including administrative and research training support, sufficient to ensure the success of the program?
• Is it clear how the proposed training program is integrated with, but distinguished from, other externally funded training programs at the institution?

For applications proposing DSTP research training positions:

• Are the plans for identifying and recruiting dual degree trainees likely to ensure the selection and matriculation of qualified individuals who are committed to obtaining both degrees and pursuing independent research careers?
• Are the timeline, phasing and integration of the research and clinical and training experiences well- reasoned, feasible, and likely to provide an effective, integrated research and clinical training experience?
• Do the structure and content of the dual degree program ease the transition between the research and clinical phases of the program, incorporate the unique research and clinical mentored/supervised training needs of each DSTP trainee, enable each individual to complete the clinical and research programs with requisite competencies in both areas, and prepare them for independent careers as dentist scientists?

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

• Does the PD/PI have the scientific background, expertise, and administrative and training experience to provide strong leadership, direction, management, and administration of the proposed research training program?
• Does the PD/PI plan to commit sufficient effort to ensure the program s success?
• Are the administrative structure and planned strategies to oversee and monitor the program likely to ensure appropriate and timely progress of trainees for the duration of each trainee's time in the program?

For applications designating multiple PDs/PIs:

• Is a strong justification provided that the multiple PD/PI leadership approach will benefit the training program and the trainees?
• 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 training program and the complementary expertise of the PD(s)/PI(s)?

Preceptors/Mentors

• Are sufficient numbers of experienced preceptors/mentors with appropriate expertise and funding available to support the number and level of trainees proposed in the application?
• Do the preceptors/mentors have strong records as researchers, including recent publications and successful competition for research support in areas directly related to the proposed research training program?
• Do the preceptors/mentors have strong records of training individuals at the level of trainees, including experience training dual degree dentist-PhDs, proposed in the program?
• Are appropriate plans in place to ensure that preceptors/mentors lacking sufficient research training and/or mentoring experience are provided co-mentoring support and/or mentor training to ensure all trainees in the program are provided with a strong and successful mentoring experience?
• 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?

Trainees

• Is a recruitment plan proposed with strategies likely to attract well-qualified trainees for the training program?
• Is there a competitive applicant pool of sufficient size and quality, at each of the proposed levels (predoctoral, postdoctoral), to ensure a successful training program?
• Are there well-defined and justified selection and re-appointment criteria as well as retention strategies?

Training Record

• How successful are the trainees (or, for new applications, other past students/postdoctorates in similar training) in completing the program?
• Has the training program ensured that trainees are productive (or, for new applications, other past students/postdoctorates in similar training) in terms of research accomplishments, publication of research conducted during the training period, and subsequent training appointments and fellowship or career development awards?
• How successful are the trainees (or, for new applications, other past dual degree dental degree and PhD predoctoral students, PhD graduate student, and postdoctoral scientists in similar training) in achieving productive scientific careers as evidenced by successful competition for research science positions in industry, academia, government or other research venues; grant support, e.g., individual NIH Fellowships (Fs), career development awards (K), career transition awards (K99/R00), research project grants (R), or other awards; receipt of honors, patents; high-impact publications; promotion in academic rank or tenure, promotion to scientific leadership positions; and/or other such measures of success?
• To what extent do trainees subsequent positions in industrial, academic, government, non-profit, for profit, or other sectors benefit from their NRSA-supported research training and directly benefit the broader biomedical research enterprise?
• Does the program propose a rigorous evaluation plan to assess the quality and effectiveness of the training? Are effective mechanisms in place for obtaining feedback from current and former trainees?

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.

Training in Methods for Enhancing Reproducibility

Does the Instruction in Methods for Enhancing Reproducibility plan describe how trainees will be instructed in principles important for enhancing research reproducibility including, at a minimum, evaluation of foundational research underlying a project (i.e., scientific premise), rigorous experimental design, consideration of relevant biological variables such as sex, authentication of key biological and/or chemical resources, data and material sharing, record keeping, and transparency in reporting? Are the rigor and transparency components sufficiently well integrated into the overall training plan, curricula, and individual trainee research projects?

The plan will be rated as ACCEPTABLE or UNACCEPTABLE, and the summary statement will provide the consensus of the review committee.

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

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)? Is the program achieving its training objectives? Has the program evaluated the quality and effectiveness of the training experience (and when applicable, short-term training experience), and is there evidence that the evaluation outcomes and feedback from trainees have been acted upon? Are changes proposed that are likely to improve or strengthen the research training experience during the next project period (may not be applicable to short-term training)? Does the program continue to evolve and reflect changes in the research area in which the training occurs?

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 training program, the level of trainee experience, and the particular circumstances of the trainees, 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? For renewal applications, are all training 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:

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

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications . Following initial peer review, recommended applications will receive a second level of review by the NIDCR 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 https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-individuals/section-1557/index.html; and https://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

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.

Institutional NRSA training grants must be administered in accordance with the current NRSA section of the NIH Grants Policy Statement - Institutional Research Training Grants.

The taxability of stipends is described in the NIH Grants Policy Statement. Policies regarding the Ruth L. Kirschstein-NRSA payback obligation are explained in the NIH Grants Policy Statement.

As specified in the NIH Revitalization Act of 1993, Ruth L. Kirschstein-NRSA recipients incur a service payback obligation for the first 12 months of postdoctoral support. Policies regarding the Ruth L. Kirschstein-NRSA payback obligation are explained in the NIH Grants Policy Statement; and more details are in the Frequently Asked Questions. Officials at the grantee institution have the responsibility of explaining the terms of the payback requirements to all prospective trainees before appointment to the training grant. Additionally, all trainees recruited into the training program should be provided with information related to the career options that might be available when they complete the program. The suitability of such career options as methods to satisfy the NRSA service payback obligation should be discussed.

Awards made primarily for educational purposes are exempted from the PHS invention requirements and thus invention reporting is not required, as described in the NIH Grants Policy Statement.

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 trainee appointed or reappointed to the training grant 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.
• Additionally, a completed Payback Agreement Form (PHS Form 6031) must be submitted for each postdoctoral trainee in his or her first 12 months of support.
• 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 trainee appointed for eight weeks or more. Trainees with service payback requirements must notify the NIH of any change in address and submit Annual Payback Activities Certification Forms (PHS Form 6031-1) until the payback service obligation is satisfied.

A final RPPR, the expenditure data portion of the Federal Financial Report, and Termination Notices for all Trainees, are required for closeout of an award as described in the NIH Grants Policy Statement.

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 ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, 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 instructions, application processes, and NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-637-3015

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]

Anissa J. Brown, PhD
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: (301) 594-4805
Email: [email protected]

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

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

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

Awards are made under the authorization of Section 487 of the Public Health Service Act as amended (42 USC 288) and under Federal Regulations 42 CFR 66