Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute of Dental and Craniofacial Research (NIDCR)

Funding Opportunity Title
Short-term Mentored Career Enhancement Award in Dental, Oral, and Craniofacial Research for Mid-Career and Senior Investigators (K18- Independent Clinical Trial Not Allowed)
Activity Code
K18 Career Enhancement Award
Announcement Type
Reissue of PAR-19-238
Related Notices

See Notices of Special Interest associated with this funding opportunity

None

Funding Opportunity Announcement (FOA) Number
PAR-22-121
Companion Funding Opportunity
None
Assistance Listing Number(s)
93.121
Funding Opportunity Purpose

The goal of the NIDCR Career Enhancement Award (K18) is to support mentored research experiences for established investigators who either wish to expand or augment their dental, oral, or craniofacial (DOC) research program, or to redirect their research by incorporating DOC research into their research program to advance fundamental knowledge about dental, oral, and craniofacial health and disease.

This Funding Opportunity Announcement (FOA) is designed specifically for candidates proposing research that does not involve leading an independent clinical trial, a clinical trial feasibility study, or an ancillary study to a clinical trial. Applicants to this FOA are permitted to propose research experience in a clinical trial led by a mentor or co-mentor.

Key Dates

Posted Date
May 09, 2022
Open Date (Earliest Submission Date)
May 12, 2022
Letter of Intent Due Date(s)

Not Applicable

The following table includes NIH standard due dates marked with an asterisk.
Application Due Dates Review and Award Cycles
New Renewal / Resubmission / Revision (as allowed) AIDS Scientific Merit Review Advisory Council Review Earliest Start Date
June 12, 2022 * July 12, 2022 * September 07, 2022 * November 2022 January 2023 April 2023
October 12, 2022 * November 12, 2022 * January 07, 2023 * March 2023 May 2023 July 2023
February 12, 2023 * March 12, 2023 * May 07, 2023 * July 2023 October 2023 December 2023
June 12, 2023 * July 12, 2023 * September 07, 2023 * November 2023 January 2024 April 2024
October 12, 2023 * November 12, 2023 * January 07, 2024 * March 2024 May 2024 July 2024
February 12, 2024 * March 12, 2024 * May 07, 2024 * July 2024 October 2024 December 2024
June 12, 2024 * July 12, 2024 * September 07, 2024 * November 2024 January 2025 April 2025
October 12, 2024 * November 12, 2024 * January 07, 2025 * March 2025 May 2025 July 2025
February 12, 2025 * March 12, 2025 * May 07, 2025 * July 2025 October 2025 December 2025

All applications are due by 5:00 PM local time of applicant organization.

Applications are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

Expiration Date
May 08, 2025
Due Dates for E.O. 12372

Not Applicable

Required Application Instructions
It is critical that applicants follow the instructions in the Career Development (K) 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.

There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

  1. Use the NIH ASSIST system to prepare, submit and track your application online.
  2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.

  3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.


  4. Table of Contents

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

The overall goal of the NIH Research Career Development program is to help ensure that a diverse pool of highly trained scientists is available in appropriate scientific disciplines to address the Nation's biomedical, behavioral, and clinical research needs. NIH Institutes and Centers (ICs) support a variety of mentored and non-mentored career development award programs designed to foster the transition of new investigators to research independence and to support established investigators in achieving specific objectives. Candidates should review the different career development (K) award programs to determine the best program to support their goals. More information about Career programs may be found at the NIH Research Training and Career Development website.

The objective of the Career Enhancement Award for Experienced Investigators (K18) is to provide support for experienced scientists who either wish to broaden their scientific capabilities or to make changes in their research careers by acquiring new research skills or knowledge. The purpose of this FOA is to provide such investigators with support for a short-term, yet intensive period of mentored research experience to acquire new research capabilities in research areas supported by the sponsoring NIH Institute(s)/Center(s). Such experiences will afford candidate investigators protected time to: 1) enrich and expand their expertise and research programs through retooling in new techniques, emerging technologies, and/or scientific areas; and/or 2) redirect their research programs in new trajectories; and/or 3) catalyze research collaborations in new research directions.  It is expected that this initiative will lead to new and/or augmented research programs competitive for NIH funding.

The NIDCR conducts and fosters research and research training on the etiology, pathogenesis, prevention, diagnosis, monitoring, and treatment of dental, oral, and craniofacial diseases and conditions. The objective of the NIDCR Career Enhancement Award in Dental, Oral, and Craniofacial (DOC) Research (K18) is to provide mid-career and senior investigators with protected time for an intensive short-term mentored research experience, from 2.4 to 12 months, to facilitate their continued research career development by acquiring new knowledge and skills in state-of-the-art techniques and technologies, and in applying innovative tools and approaches to advancing DOC research and discovery. Candidates may be either experienced DOC researchers seeking career enhancement in scientific areas outside of their current expertise, or experienced investigators in other research areas who are seeing career enhancement in DOC research.

The proposed career enhancement activities may be conducted in the same or different department/school within the candidate's home institution where the candidate holds a primary appointment, or at a different institution. The host mentoring laboratory/research program must have appropriate research facilities and resources to support the candidate’s research and other career enhancement activities.

Candidates must identify one or more mentors with extensive research experience in an appropriate domain or discipline to guide the candidate. The mentor(s) must be established and well-qualified investigators and agree to support the candidate’s short-term experience. The proposed career enhancement experience is expected to be a novel extension of the candidate’s current research program, must be tailored to the candidate, and have the potential to substantially impact the candidate’s research capabilities, and to provide new research opportunities and benefits that would not be achievable through a collaborative research grant with the mentor(s). The candidate and the proposed mentor(s) should not have an ongoing or existing collaboration at the time of the application. Candidates are expected to establish new collaborations for this program. Diverse multidisciplinary teams are encouraged. The candidate must justify why the proposed career enhancement plan will facilitate the goals of this NIDCR K18 program in a manner that could not be achieved solely through a research grant or current collaborative arrangement.

This NIDCR K18 will support dental, oral, and craniofacial career enhancement experiences in in areas consistent with the research priorities of the NIDCR, including the Behavioral and Social Sciences Research Program, Clinical Research Programs, Translational Genetics and Genomics Programs, and the Integrative Biology and Infectious Disease Research Programs.

Behavioral and Social Sciences Research Priorities for this FOA:

The NIDCR behavioral and social sciences program supports both basic and applied research to promote oral health, to prevent oral/dental diseases and related disabilities, and to improve management of craniofacial conditions, disorders, and injury. Mentored experiences are encouraged that facilitate the application of theories, tools, methods, or approaches from the behavioral or social sciences to oral health challenges.

Clinical Research Program Priorities for this FOA:

The NIDCR clinical research program supports research aimed at improving dental, oral and craniofacial health through clinical trials, practice-based research, epidemiologic studies, clinical technology research, studies of oral health disparities and inequities, and HIV/AIDS and oral health. Mentored experiences are encouraged that provide clinical research experiences or develop measures, tools or methods to be used in future clinical research proposals.

Translational Genetics and Genomics Research Programs Priorities for this FOA:

The NIDCR Translational Genomics Research Program supports studies that identify epi/genetic, environmental, and behavioral factors and biological pathways that underlie the physiology and pathology through DOC development at cellular, tissue, organ, and organismal/individual levels as well as data science projects that develop or apply data science and computational methods and resources to accelerate knowledge discovery and translation of dental, oral, and craniofacial biology to improve health or clinical efficacy. A collaborative partnership can be arranged through an investigator seeking mentorship from another investigator in a complementary area of expertise.

Integrative Biology and Infectious Disease Research Program Priorities for this FOA:

The NIDCR Integrative Biology and Infectious Disease Research Program supports basic and translational research in oral microbiology; salivary gland biology; oral immunology; oral, oropharyngeal, and salivary gland cancers; orofacial pain and temporomandibular joint disorders; mineralized tissue physiology; dental materials and biomaterials; and tissue engineering and regenerative medicine. Mentored experiences are encouraged that provide research experiences in these areas with new collaborations and diverse multidisciplinary teams.

In addition, this NIDCR K18 re-issue expands DOC career enhancement experiences for investigators seeking new mentored/collaborative experiences in the following areas:

  • Research activities at any stage along the spectrum of translational science, from basic science to interventions that improve individual health to public health. All stages of the translational spectrum include development of new approaches, demonstration of their usefulness, and dissemination of the findings. All research enhancement experiences must be directed towards improving DOC health. Examples include preclinical research experiences for basic scientists or investigating clinical applications of basic research.
  • Experiences in technology discovery, product development, and related research activities that facilitate the commercialization of academic DOC technologies as supported by NIDCR Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) research programs.
  • Career enhancement experiences that use novel, emerging or cutting-edge technology, multidisciplinary and diverse team approaches with high potential to advance any field of DOC research that aligns with NIDCR grant programs. Strong justification must be provided for the novel or cutting-edge approach and the high potential to advance DOC research.

All research experience must align with research priorities of NIDCR grant programs, which can be found at https://www.nidcr.nih.gov/grants-funding/grant-programs. Prospective applicants are strongly encouraged to contact an NIDCR program official to discuss their research goals, specific programmatic information, and NIDCR research priorities.

Note: This Funding Opportunity Announcement (FOA) is designed specifically for applicants proposing research that does not involve leading an independent clinical trial, a clinical trial feasibility study, or an ancillary clinical trial. Applicants to this FOA are permitted to propose research experience in a clinical trial led by a mentor or co-mentor.

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

Section II. Award Information

Funding Instrument

Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed
New
Resubmission
The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.
Clinical Trial?

Not Allowed: Only accepting applications that do not propose clinical trials.

Note: Applicants may propose to gain experience in a clinical trial led by a mentor/co-mentor as part of their research career development.

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

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

A project period from 2.4 calendar months to 12 calendar months may be requested.

Other Award Budget Information

Salary

NIDCR will contribute a minimum of 2.4 person months up to a maximum of 6 person months of full-time professional effort per year toward the salary of the career award recipient.

The total NIDCR contribution to salary may not exceed the legislatively mandated salary cap.  See: http://grants.nih.gov/grants/policy/salcap_summary.htm

In addition, the candidate may derive additional compensation for effort associated with other Federal sources or awards provided the total salary derived from all Federal sources does not exceed the maximum legislated salary rate and the total percent effort does not exceed 100%.

Other Program-Related Expenses

NIH will contribute $25,000 per year toward the research development costs of the award recipient, which must be justified and consistent with the stage of development of the candidate and the proportion of time to be spent in research or career development activities.

Allowable costs include tuition and fees for short-term courses, travel to scientific meetings or training, consultant fees, and research-related costs, primarily supplies and technical or computational services. Salary for research assistants, laboratory technicians, or equivalent research staff may be appropriate.

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

Indirect Costs
Indirect Costs (also known as Facilities & Administrative [F&A] Costs) are reimbursed at 8% of modified total direct costs.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Governments

  • State Governments
  • County Governments
  • City or Township Governments
  • Special District Governments
  • Indian/Native American Tribal Governments (Federally Recognized)
  • Indian/Native American Tribal Governments (Other than Federally Recognized)
  • U.S. Territory or Possession
Other
  • Independent School Districts
  • Public Housing Authorities/Indian Housing Authorities
  • Native American Tribal Organizations (other than Federally recognized tribal governments)
  • Faith-based or Community-based Organizations
  • Regional Organizations
Foreign Institutions
Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are allowed. 
Required Registrations

Applicant Organizations

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

  • 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.
    • Unique Entity Identifier (UEI)- A UEI is issued as part of the SAM.gov registration process. SAM registrations prior to fall 2021 were updated to include a UEI. For applications due on or after January 25, 2022, the UEI must be provided on the application forms (e.g., FORMS-G); the same UEI must be used for all registrations, as well as on the grant application.
    • Dun and Bradstreet Universal Numbering System (DUNS) – Organization registrations prior to April 2022 require applicants to obtain a DUNS prior to registering in SAM. By April 2022, the federal government will stop using the DUNS number as an entity identifier and will transition to the Unique Entity Identifier (UEI) issued by SAM. Prior to April 2022, 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.
  • eRA Commons - Once the unique organization identifier (DUNS prior to April 2022; UEI after April 2022) is established, organizations can register with eRA Commons in tandem with completing their full SAM and Grants.gov registrations; 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 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.

All PD(s)/PI(s) must be registered with ORCID. The personal profile associated with the PD(s)/PI(s) eRA Commons account must be linked to a valid ORCID ID. For more information on linking an ORCID ID to an eRA Commons personal profile see the ORCID topic in our eRA Commons online help.

Eligible Individuals (Program Director/Principal Investigator)

Any candidate with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director/Principal Investigator (PD/PI) is invited to work with his/her mentor and organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019. Multiple PDs/PIs are not allowed.

By the time of award, the individual must be a citizen or a non-citizen national of the United States or have been lawfully admitted for permanent residence (i.e., possess a currently valid Permanent Resident Card USCIS Form I-551, or other legal verification of such status).

Candidates for the K18 award must have a research or health-professional doctoral degree. This award is intended for well-established investigators who have established records of independent, peer-reviewed Federal or private research grant funding. Applicants are not required to have active research grant support at the time of application for this award.

3. Additional Information on Eligibility

Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct, and each is from a different candidate.

The NIH will not accept duplicate or highly overlapping applications under review at the same time per 2.3.7.4 Submission of Resubmission Application. An individual may not have two or more competing NIH career development applications pending review concurrently. In addition, NIH will not accept:

  • A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
  • A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
  • An application that has substantial overlap with another application pending appeal of initial peer review. (See 2.3.9.4 Similar, Essentially Identical, or Identical Applications).
Level of Effort

At the time of award, the candidate must have a “full-time” appointment at the academic institution. Candidates are required to commit a minimum of 75% of full-time professional effort (i.e., a minimum of 9 person-months) to their program of career development. Candidates may engage in other duties as part of the remaining 25% of their full-time professional effort not covered by this award, as long as such duties do not interfere with or detract from the proposed career development program. 

Candidates who have VA appointments may not consider part of the VA effort toward satisfying the full time requirement at the applicant institution. Candidates with VA appointments should contact the staff person in the relevant Institute or Center prior to preparing an application to discuss their eligibility.

After the receipt of the award, adjustments to the required level of effort may be made in certain circumstances.  See NOT-OD-18-156  and NIH Grants Policy Statement, Section 12.3.6.4 Temporary Adjustments to the Percent Effort Requirement for more details.

Mentor(s)


Before submitting the application, the candidate must identify a mentor who will supervise the proposed career development and research experience. The mentor should be an active investigator in the area of the proposed research and be committed both to the career development of the candidate and to the direct supervision of the candidate’s research. The mentor must document the availability of sufficient research support and facilities for high-quality research. Candidates are encouraged to identify more than one mentor, i.e., a mentoring team, if this is deemed advantageous for providing expert advice in all aspects of the research career development program. In such cases, one individual must be identified as the primary mentor who will coordinate the candidate’s research. The candidate must work with the mentor(s) in preparing the application. The mentor, or a member of the mentoring team, should have a successful track record of mentoring individuals at the candidate’s career stage. Where feasible, the recruitment of women, individuals from diverse racial and ethnic groups, and individuals with disabilities as potential mentors is encouraged, given their ability to serve as role models.

The mentor(s) or mentoring team must demonstrate appropriate expertise, experience, and ability to guide the applicant in the organization, management and implementation of the proposed research.

Institutional Environment

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

Section IV. Application and Submission Information

1. Requesting an Application Package

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

2. Content and Form of Application Submission

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

For information on Application Submission and Receipt, visit Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.

Page Limitations

All page limitations described in the SF424 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.

Other Project Information

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

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

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

R&R Budget

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

PHS 398 Cover Page Supplement

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

PHS 398 Career Development Award Supplemental Form

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

Candidate
Research Plan
Other Candidate Information
Mentor, Co-Mentor, Consultant, Collaborators
Environment & Institutional
Commitment to the Candidate
Other Research Plan Sections
Appendix

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

Candidate Section

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

Candidate Information and Goals for Career Development

Candidate’s Background

  • Describe the candidate's commitment to a career as a health related research scientist. 
  • Describe the candidate's research efforts and accomplishments in health related research to date as an independent investigator, including publications, prior research interests and experience, and history of research support. 
  • Present evidence of the candidate's potential to augment his/her research career and to ultimately advance scientific progress through this career enhancement plan. 
  • Provide evidence of the candidate's ability to interact and collaborate with other scientists, particularly those from other disciplines.
  • For candidates new to dental, oral, and craniofacial research, provide evidence that the candidate has the potential to develop as an independent and productive researcher in dental, oral, and craniofacial research.
  • For candidates established in dental, oral, and craniofacial research, provide evidence that the candidate has the potential to successfully expand their existing research program to incorporate new or novel theories, tools, methods, or approaches, including state-of-the-art and cutting-edge technologies and approaches.

Career Goals and Objectives​

  • Describe the candidate's research career trajectory to date and future career goals and objectives and explain how these relate to the proposed dental, oral, and craniofacial research career development enhancement program.
  • Justify the need for further career enhancement in order to achieve the candidate's future research goals. 
  • Demonstrate how the proposed career enhancement program and the research, educational and mentoring resources of the sponsoring laboratory and institution will further the stated research career goals.

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

  • The candidate and the mentor are jointly responsible for the preparation of the career development plan. The candidate and mentor may propose a mentoring team. 
  • Describe the career development plan, tailoring it to the candidate's goals, prior experience and career level, as well as to the intent of the K18 program. 
  • Provide a systematic plan for progression of career enhancement and research experiences for the period of the award and beyond, including a timeline for the phasing of the career enhancement and research activities. 
  • Explain how the career development plan will enhance the candidate’s independent research career trajectory, including a description of any cutting-edge research skills and conceptual knowledge that will be acquired during the career award period.
  • Describe any clinical, administrative, teaching, mentoring or grant-related research commitments the applicant will maintain during the period of the award, and the arrangements to be made with the applicant institution and/or the host institution to ensure the requisite protected time for this award period.
  • If the candidate proposes to work with a mentor with whom they have had previous research collaboration, include justification as to why this mentored experience will facilitate career development that could not be achieved solely through a research grant or collaborative arrangement.

Research Plan Section

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

Research Strategy

  • A sound research project that is consistent with the candidate’s level of research development and objectives of his/her career development plan must be provided. The research description should demonstrate the quality of the candidate’s research thus far and also the novelty, significance, creativity and approach, as well as the ability of the candidate to carry out the research.
  • The application must also describe the relationship between the mentor’s research and the candidate’s proposed research plan.
  • Although it is not expected that the description of the research would be as detailed as an application for an investigator-initiated research grant (e.g., R01), enough information should be provided to permit an evaluation of the scientific merit of the candidate's research activities and mentored career development.
  • If the applicant is proposing to gain experience in a clinical trial, ancillary clinical trial or a clinical trial feasibility study as part of his or her research career development, describe the relationship of the proposed research project to the clinical trial.

Training in the Responsible Conduct of Research

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

Mentor, Co-Mentor, Consultant, Collaborators Section

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

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

  • The candidate must name a primary mentor who, together with the candidate, is responsible for the planning, directing, monitoring, and executing the proposed program.  The candidate may also nominate co-mentors as appropriate to the goals of the program.  
  • The mentor should have sufficient independent research support to cover the costs of the proposed research project in excess of the allowable costs of this award. 
  • Include a statement that the candidate will commit a minimum of 2.4 up to a maximum of 6 person months (20% to 50% of full-time professional effort) to the career development program and related career development activities. 
  • The application must include a statement from the mentor providing: 1) information on his/her research qualifications and previous experience as a research supervisor; 2) a plan that describes the nature of the supervision and mentoring that will occur during the proposed award period; 3) a plan for career progression for the candidate to move from the mentored stage of his/her career to independent research investigator status during the project period of the award; and 4) a plan for monitoring the candidate’s research, publications, and progression towards independence. 
  • Similar information must be provided by any co-mentor.  If more than one co-mentor is proposed, the respective areas of expertise and responsibility of each should be described.  Co-mentors should clearly describe how they will coordinate the mentoring of the candidate. If any co-mentor is not located at the sponsoring institution, a statement should be provided describing the mechanism(s) and frequency of communication with the candidate, including the frequency of face-to-face meetings.
  • If the applicant is proposing to gain experience in a clinical trial as part of his or her research career development, the mentor or a member of the mentoring team must include a statement to document leadership of the clinical trial, and appropriate expertise to guide the applicant in any proposed clinical trials research experience. 
  • The primary mentor must agree to provide annual evaluations of the candidate’s progress as required in the annual progress report.
  • The mentor must be recognized as an accomplished investigator in the proposed research area and have a track record of success in training independent investigators.
  • If the candidate is proposing to gain experience in a clinical trial as part of his or her research career development, the mentor or co-mentor of the mentoring team must include a statement to document leadership of the clinical trial, and appropriate expertise to guide the applicant in any proposed clinical trials research experience.

Letters of Support from Collaborators, Contributors and Consultants

  • Signed statements must be provided by all collaborators and/or consultants confirming their participation in the project and describing their specific roles. Unless also listed as senior/key personnel, collaborators and consultants do not need to provide their biographical sketches. However, information should be provided clearly documenting the appropriate expertise in the proposed areas of consulting/collaboration. 
  • Advisory committee members (if applicable): Signed statements must be provided by each member of the proposed advisory committee.  These statements should confirm their participation, describe their specific roles, and document the expertise they will contribute.  Unless also listed as senior/key personnel, these individuals do not need to provide their biographical sketches. 

Environmental and Institutional Commitment to the Candidate

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

Description of Institutional Environment

  • The sponsoring institution must document a strong, well-established research and career development program related to the candidate's area of interest, including a high-quality research environment with key faculty members and other investigators capable of productive collaboration with the candidate. 
  • Describe how the institutional research environment is particularly suited for the development of the candidate's research career and the pursuit of the proposed research plan.
  • Describe the resources and facilities that will be available to the candidate. 

Institutional Commitment to the Candidate’s Research Career Development

  • The sponsoring institution must provide a statement of commitment to the candidate's development into a productive, independent investigator and to meeting the requirements of this award. It should be clear that the institutional commitment to the candidate is not contingent upon receipt of this career award. 
  • Provide assurances that the candidate will be able to devote the required effort to activities under this award. The remaining effort should be devoted to activities related to the development of the candidate’s career as an independent scientist. 
  • Provide assurances that the candidate will have access to appropriate office and laboratory space, equipment, and other resources and facilities (including access to clinical and/or other research populations, as applicable) to carry out the proposed research plan. 
  • Provide assurance that appropriate time and support will be available for any proposed mentor(s) and/or other staff consistent with the career development plan.

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.

PHS Human Subjects and Clinical Trials Information

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

The following additional instructions apply:
  • For FOAs that do not allow independent clinical trials, do not complete Section 4 – Protocol Synopsis information or Section 5 - Other Clinical Trial-related Attachments.

Delayed Onset Study

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

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

PHS Assignment Request Form

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

Reference Letters

Candidates must carefully follow the SF424 (R&R) Application Guide, including the time period for when reference letters will be accepted. Applications lacking the appropriate required reference letters will not be reviewed. This is a separate process from submitting an application electronically. Reference letters are submitted directly through the eRA Commons Submit Referee Information link and not through Grants.gov. 

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

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

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

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.

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

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

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential fieldof the Senior/Key Person Profile form. Failure to register in the eRA 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 unique entity identifier (DUNS number or UEI as required) provided on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. 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 aby the Center for Scientific Review and will be evaluated for compliance by the NIDCR with application instructions.

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

1. Criteria

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.

Overall Impact

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

Scored Review Criteria

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact.

  Candidate

  • Has the candidate provided evidence of excellence as an independent investigator, including a record of research support and peer-reviewed publications?
  • Does the candidate show evidence of a high level of commitment to meeting the program's career enhancement objectives?
  • Does the candidate have high potential for successfully augmenting his/her research career capabilities and becoming an outstanding contributor to the research field relevant to the proposed research enhancement experience?
  • For candidates new to dental, oral, and craniofacial research, does the candidate have the potential to develop as an independent and productive researcher in dental, oral, and craniofacial research?
  • For candidates established in dental, oral, and craniofacial research, does the candidate have the potential to successfully expand his/her existing research program to incorporate new or novel theories, tools, methods or approaches, including state-of-the-art and cutting edge technologies and approaches?

Career Development Plan/Career Goals and Objectives  

  • Is the career development plan appropriate in its content, scope, duration, and phasing for the candidate's stated career development goals?
  • What is the likelihood that the career enhancement and mentoring plans will contribute substantially to the scientific development of the candidate leading to rigorous dental, oral and craniofacial research?
  • Is an appropriate level of the candidate's professional effort to the career development plan documented in the application?
  • Is there an adequate description of the need for further career enhancement of the candidate as it relates to rigorous dental, oral, and craniofacial research?
  • Is there sufficient justification as to why this program will facilitate career development that could not be achieved solely through a research grant or collaborative effort?

Research Plan

  • Is the prior research that serves as the key support for the proposed project rigorous?
  • Has the candidate included plans to address weaknesses in the rigor of prior research that serves as the key support of the proposed project?
  • Has the candidate presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed?
  • Has the candidate presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?
  • Are the proposed research question(s), design, and methodology of significant scientific and technical merit?
  • Is the proposed research a novel extension of the candidate's research?
  • Is the research plan relevant to the candidate’s research enhancement objectives?
  • Is the research plan appropriate to the stage of research development and as a vehicle for developing the research skills described in the career enhancement plan?
  • Is the research plan appropriate for developing a rigorous research program in dental, oral, and craniofacial research?
  • If proposed, will the clinical trial experience contribute to the research project?

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

  • Are the proposed collaborations with other active investigators and other opportunities for professional growth appropriate and of high quality? 
  • Is adequate information provided that clearly documents expertise in the proposed area(s) of consulting/collaboration?
  • To what extent are the mentor's research qualifications, experience, scientific stature and mentoring track record appropriate for the candidate's career development needs?
  • Is there evidence of the mentor's previous experience in fostering the development of independent investigators?
  • Is there evidence of the mentor's research productivity and peer-reviewed research support?
  • How well do the research activities of the candidate dovetail with the mentor's research funding and ongoing activities?
  • Is the source(s) of funding, beyond what is provided by the K18 award, described and adequate for the proposed research and career enhancement activities?
  • If co-mentors, consultants, and/or collaborators are identified, is there adequate description of roles and how each person will contribute to the career enhancement of the candidate?
  • Is the coordination of mentoring reasonable? Will there be adequate communication and personal meetings with the candidate?
  • Do the statements from consultants/contributors clearly state their role(s) in the career development of the candidate?
  • If the applicant is proposing to gain experience in a clinical trial as part of his or her research career development, is there evidence of the appropriate expertise, experience, and ability on the part of the mentor(s) to guide the applicant during participation in the clinical trial?

Environment & Institutional Commitment to the Candidate

  • Are the research facilities, resources and training opportunities, including faculty capable of productive collaboration, available to the candidate?
  • Is there clear commitment from the institution(s) to ensure that the candidate will devote the requisite effort directly to the research career enhancement activities described in the application?
  • Is there strong institutional commitment to fostering the candidate’s advanced research career development? Are there unique features of the scientific environment of the institution(s) that will benefit the proposed research and career development plan (e.g., useful collaborative arrangements, special equipment or analytic methods, unique subject populations)?
  • Is there a strong commitment from the candidate's home institution to ensure that 2.4-6 person-months of the candidate’s full-time professional effort will be dedicated to the research career enhancement plan during the active period of the award?
  • Is there a strong commitment for the success of the mentored experience, including the proposed research project, from the mentor's (host) institution?
  • Are the host laboratory/research program and institution well suited for the advanced development of the candidate’s research career and the pursuit of the proposed career enhancement activities and research plan?
  • Is the environment for scientific and professional development of the candidate of high quality?
Additional Review Criteria
As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

Protections for Human Subjects

For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Individuals Across the Lifespan

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

Vertebrate Animals

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

Biohazards

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

Resubmissions

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

Revisions

Not Applicable

Additional Review Considerations

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

Resource Sharing Plans

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

Training in the Responsible Conduct of Research

All applications for support under this FOA must include a plan to fulfill NIH requirements for instruction in the Responsible Conduct of Research (RCR). Taking into account the level of experience of the candidate, including any prior instruction or participation in RCR as appropriate for the candidate’s career stage, the reviewers will evaluate the adequacy of the proposed RCR training in relation to the following five required components: 1) Format - the required format of instruction, i.e., face-to-face lectures, coursework, and/or real-time discussion groups (a plan with only on-line instruction is not acceptable); 2) Subject Matter - the breadth of subject matter, e.g., conflict of interest, authorship, data management, human subjects and animal use, laboratory safety, research misconduct, research ethics; 3) Faculty Participation - the role of the mentor(s) and other faculty involvement in the fellow’s instruction; 4) Duration of Instruction - the number of contact hours of instruction (at least eight contact hours are required); and 5) Frequency of Instruction –instruction must occur during each career stage and at least once every four years. Plans and past record will be rated as ACCEPTABLE or UNACCEPTABLE, and the summary statement will provide the consensus of the review committee. See also: NOT-OD-10-019.

Select Agent Research

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

Authentication of Key Biological and/or Chemical Resources:

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

Budget and Period of Support

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

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

  • 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 appropriate national Advisory Council or Board.

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

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. 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

1. Award Notices

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

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

Recipients 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.

Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: Generaland 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:

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.

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 theFederal 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.

3. Reporting

When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement. The Supplemental Instructions for Individual Career Development (K) RPPRs must be followed. For mentored awards, the Mentor’s Report must include an annual evaluation statement of the candidate’s progress.

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.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All recipients 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 the threshold.  See the NIH Grants Policy Statement for additional information on this reporting requirement. 

In accordance with the regulatory requirements provided at 45 CFR 75.113 and 2 CFR Part 200.113 and Appendix XII to 45 CFR Part 75 and 2 CFR Part 200, 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 and 2 CFR Part 200 – Award Term and Condition for Recipient Integrity and Performance Matters.

4. Evaluation

In carrying out its stewardship of human resource-related programs, the NIH may request information essential to an assessment of the effectiveness of this program 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.

Application Submission Contacts

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: 301-945-7573

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

Scientific/Research Contact(s)

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

Peer Review Contact(s)

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

Financial/Grants Management Contact(s)

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

Section VIII. Other Information

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

Please note that the NIH Loan Repayment Programs (LRPs) are a set of programs to attract and retain promising early-stage investigators in research careers by helping them to repay their student loans. Recipients of career development awards are encouraged to consider applying for an extramural LRP award.

Authority and Regulations

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75 and 2 CFR Part 200.

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