Part 1. Overview Information

Key Dates

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

Applicants 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.

It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide , except where instructed to do otherwise (in this NOFO or in a Notice from NIH Guide for Grants and Contracts).

Conformance to all requirements (both in the Application Guide and the NOFO) 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 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

Purpose

The objective of the NIDCR Award for Sustaining Outstanding Achievement in Research (SOAR) is to provide longer-term support to NIDCR-funded investigators, who are in their mid-career stage, and have outstanding records of research productivity, mentorship, and professional service to the research community. It is expected that the SOAR Award will propel the investigator along this career trajectory and allow them to embark on ambitious longer-term projects of extraordinary potential within the mission of NIDCR. This award supports research projects for up to eight years.

Background

The overall goal of this initiative is to provide sustained and flexible support to NIDCR-funded investigators, who are in their mid-career stage, and have outstanding records of research productivity, to conduct exceptionally innovative research with extraordinary potential for improving dental, oral, and craniofacial health. This award provides longer base of grant support, allowing investigators to have more freedom to perform high-risk, high-reward research that has the potential to break new ground or expand previous discoveries in new directions. It is anticipated that sustained and flexible support will also foster creativity, allow emerging scientific and technological advances to be pursued, maximize research time, enable additional mentoring activities, and provide an opportunity to focus on enhancing career growth. This NOFO requires the investigator to develop a broadly defined research program, including future scientific directions and strategies that build on prior research accomplishments in the area of dental, oral, and craniofacial health and disease.

Features and Requirements

During the SOAR Award, investigators have the freedom, within the broadly defined scope of the research, to move in unanticipated directions, with an emphasis on research of high-risk, high-reward, or of extraordinary potential.

The required minimum level of effort is 6.12 person months.    

Awardees are required to consolidate their NIDCR single PD/PI research grant support, including R01, R21, R03, R56, R15, and DP2 support. The consolidated research program must include the broad scope of work within the grants folded into the SOAR Award. Grant mechanisms excluded from consolidation are NIDCR-supported multiple PD/PI grants, cooperative agreements, contracts, conference grants, institutional training grants, fellowships, career development awards, SBIR/STTR grants, and grants supported from outside of NIDCR. Time and effort on these existing NIDCR grants that are excluded from consolidation will be renegotiated to accommodate the required minimum level of effort for the SOAR Award.   The level of support of the SOAR Award in Year 1 will take into consideration the amount of unobligated balance in grants that are consolidated.

Awardees may apply for additional NIDCR support only during Years 6-8 of the SOAR Award. These new NIDCR awards will not be consolidated into the SOAR Award. If the PD/PI receives new NIDCR awards in Years 6-8 of the SOAR Award, the level of effort for the SOAR Award may be reduced, subject to negotiation and approval from NIDCR. Awardees may apply for support from other NIH Institutes and Centers at any time, as well as from NIDCR only for grant mechanisms excluded from consolidation.

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

Section II. Award Information

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

Section III. Eligibility Information

1. Eligible Applicants

All organizations administering an eligible parent award may apply for a supplement under this NOFO.

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)

Local 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)

Federal Government

• Eligible Agencies of the Federal Government
• U.S. Territory or Possession

Other

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

Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.

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

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted 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. The same UEI must be used for all registrations, as well as on the grant application.
• eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.gov registration; 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.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with their organization to develop an application for support. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women 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.

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Only single PD/PI applications are allowed. Applications with multiple PD(s)/PI(s) will NOT be accepted.

Eligibility is limited to investigators with at least one active NIDCR-supported PD/PI R01 or R01 equivalent (U01, R56, DP2 only), AND at least five years of continuous NIDCR support as PD/PI, on September 30, 2023, excluding fellowships and career development awards. The following funding mechanisms are considered as part of the continuous NIDCR support: R01, R00, R56, DP2, R15, UH3, or U01 only. Only the first no cost extension year of the NIDCR-supported R01 or R01 equivalent award counts as one year of active NIDCR support. All other additional no cost extension years do not count toward continuous support years.

In addition, applicants must have no more than ten years of research career experience following the loss of their Early Stage Investigator (ESI) status at the time of application. Loss of ESI status could be due to receipt of a competitive substantial NIH independent research award, or expiration of status. Not counted toward research time within the ten years following the loss of ESI status is well-justified leave for personal or family situations such as illness, disability, active military service, parental leave or family care responsibilities, or time spent in clinical training or clinical care unrelated to research. Any time away from research within the ten years following the loss of ESI status should be explained in the Biographical Sketch.

This award targets investigators in their mid-career stage, and is NOT intended for supporting new and early stage investigators, or well-established investigators. Applicants are highly encouraged to contact NIDCR staff to assess suitability prior to application submission.

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

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

Section IV. Application and Submission Information

1. Requesting an Application Package

The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this NOFO. 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 Research (R) Instructions in the How to Apply - Application Guide except where instructed in this notice of funding opportunity to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Letter of Intent

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

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

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

The letter of intent should be sent to:

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

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

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

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

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

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

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

Biographical Sketch: Use the Personal Statement to describe track record of mentorship and professional service to the research community, which are review elements under the criterion Investigator. If applicable, include explanation and dates of any time away from research that should not be counted toward the ten years of research career experience following the loss of Early Stage Investigator (ESI) status at the time of application.

R&R Budget

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

Level of Effort: The required minimum level of effort is 6.12 person months. PDs/PIs with effort on other grant support will be expected to provide, as part of the Just-in-Time information, a detailed explanation describing how effort on his/her other grants will be adjusted, if necessary, to permit 6.12 person months on the SOAR Award.

R&R Subaward Budget

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

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

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

Specific Aims: DO NOT submit Specific Aims.

Research Strategy : Upload the Research Strategy as a single attachment containing the following sections:

• Background: Describe the general area of dental, oral, and craniofacial research of interest and its state of the science. Identify significant knowledge gaps across the research landscape and challenges to bridge theses gaps. Describe the overall scope and impact of the proposed research program to the field.
• Research Program: Describe the overall vision, conceptual framework, and roadmap to pursue broad and challenging research questions/directions, and general strategies for furthering and sustaining this research program, including plans for building on prior accomplishments to formulate a highly innovative program for advancing and transforming the research field. Describe how the research program could evolve as the work is being performed and how the risks and challenges will be addressed. Experimental details and extensive preliminary data are not required but information may be included if it is critical for assessing the feasibility of research methodologies.
• Predictors of Success: Describe elements that contribute to the strong prediction of success in continuing and maintaining a soaring trajectory in groundbreaking research, such as collaborative network, resources, environment, and relevant technological advances.
• Suitability for the SOAR Program: Applicants are required to justify that their career stage suits the SOAR program, and demonstrate that the scope of research is sufficiently comprehensive, forward-thinking, and innovative to follow a soaring trajectory and benefit from increased flexibility and duration of the SOAR Program.

Letters of Support: A single letter of support is required from the applicant's institution and from a person at the institution who has the authority to evaluate and endorse the outstanding research productivity of the PD/PI and his/her career potential. This letter should also describe institutional commitment, for example, salary support, research space, protected research time, and/or access to cores/facilities, as well as commitment of the institution to the requirements of the application and award. Letters of support from collaborators participating in the PD/PI's SOAR Program are allowed for detailing the nature of the collaboration.

Resource Sharing Plan:

Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide. 

Other Plan(s):

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages.

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

• All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan.

Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

When involving human subjects research, clinical research, and/or NIH-defined 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.

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.

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

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

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

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 Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications.

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.

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.

It is anticipated that the terms of award will include, but not be limited to, the following:

• Carryover of an unobligated balance from one budget period to another budget period will require NIDCR Grants Management Officer prior approval.
• Awards funded under this NOFO will not be provided the authority to extend the final budget period of the previously approved project period one time for up to 12 months beyond the original expiration date shown in the Notice of Award, as outlined in the NIH Standard Award Terms and Conditions. All extensions, including the first extension, will require NIH prior approval.
• A permanent change of PD/PI will not be allowed under the SOAR award. A temporary change of PD/PI or a temporary reduction in effort may be allowed with prior approval under circumstances such as sabbatical leave, medical conditions, disability, or personal or family situations such as care of a family member.
• Change of grantee institution will be allowable if the receiving institution agrees to all of the required SOAR Award terms. Transfer of a SOAR Award to a foreign institution will not be allowed.
• Awardees are required to consolidate their NIDCR single PD/PI research grant support, including R01, R21, R03, R56, R15, and DP2 support. Grant mechanisms excluded from consolidation are NIDCR-supported multi-PI grants, cooperative agreements, contracts, conference grants, institutional training grants, fellowships, career development awards, SBIR/STTR grants, and grants supported from outside of NIDCR. Time and effort on these existing NIDCR grants that are excluded from consolidation will be renegotiated to accommodate the required 6.12 person months minimum level of effort for the SOAR Award.
• Awardees may apply for additional NIDCR support as single PD/PI only during years 6-8 of the SOAR Award. These new NIDCR awards will not be consolidated into the SOAR Award. If the PD/PI receives new NIDCR awards in years 6-8 of the SOAR Award, the level of effort for the SOAR Award may be reduced, subject to negotiation and approval from NIDCR. Awardees may apply for support from other NIH Institutes and/or Centers at any time, as well as from NIDCR only for grant mechanisms excluded from consolidation.

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 form. 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. See Section III of this NOFO for information on registration requirements.

The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier 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 and compliance with application instructions by the Center for Scientific Review and responsiveness by NIDCR, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

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.

For this particular announcement, note the following:

The overall goal of this initiative is to provide sustained and flexible support to NIDCR-funded investigators, who are in their mid-career stage, and have outstanding records of research productivity, mentorship and professional service to the research community, to conduct exceptionally innovative research with extraordinary potential for improving dental, oral, and craniofacial health. Emphasizing on the general scope of the project, not the details of the experimental approach, reviewers should assess the significance, risk/feasibility, innovation, potential impact, and likelihood of success in the context of the investigator's career stage and past productivity. Reviewers will evaluate the suitability for the SOAR program i.e., whether the scope of research is sufficiently comprehensive, forward-thinking, and innovative to follow a soaring trajectory and benefit from increased flexibility and duration of the SOAR Program.

Overall Impact

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

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. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Specific to this NOFO : Is the vision for the program broad in scope and appropriate for long-term pursuit? How will the proposed research break new ground or expand previous discoveries in new directions?