Research Applications Requesting $500,000 or More in Direct Costs for Any Project Year

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  1. Purpose
  2. Scope
  3. Process
  4. Staff Consultation
  5. Supporting Information
  6. Notification of NIDCR Decision
  7. Submitting the Application
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Purpose

This document describes National Institute of Dental and Craniofacial Research’s (NIDCR) implementation of the NIH policy requiring research applications that request $500,000 or more in direct costs in any one year (excluding consortium facilities and administrative (F&A) costs) to obtain documented approval from the institute stating that it will accept a research application for initial peer review. This policy applies to new, resubmission, renewal, and revision applications. Although applicants can ask for up to $499,999 without prior approval, the system may round up dollar figures to $500,000, which NIDCR will not accept without prior approval.

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Scope

Prospective applicants should refer to Section II (Award Information) and Section IV (Application and Submission Information) of the individual notice of funding opportunity (NOFO) to which they are responding for information about applications requesting $500,000 or more in direct costs in any project year. Below are the procedures and information required for NIDCR’s decision to accept or decline such an application.

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Process

To request that NIDCR accept primary assignment of an application that includes direct costs of $500,000 or more in any one year, a potential applicant must:

  1. Contact an NIDCR Scientific/Research Contact listed in the NOFO of interest and describe the proposed research project via email or a conference call (i.e., Staff Consultation):
    • At least 8 weeks before submitting the application when submitting applications to PAR-25-057, PAR-25-188, or PAR-25-239 or subsequent reissues, as described in Section IV of these NOFOs.
    • At least 6 weeks before submitting the application to other NOFOs in which NIDCR participates.
  2. Submit Supporting Information to NIDCR at least 5 weeks before the due date of the planned application.
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Staff Consultation

Staff Consultation is the first step in requesting approval for NIDCR to accept primary assignment of an application with direct costs of $500,000 or more in any one year. It must occur at least 8 weeks before submitting an application to PAR-25-057, PAR-25-188, or PAR-25-239 and must occur at least 6 weeks before submitting an application to other NOFOs. Staff Consultation is a discussion between the NIDCR Scientific/Research Contact (program official) listed on the NOFO of interest and the potential Principal Investigator (and other potential key personnel, if interested) to describe the proposed research project. The Scientific/Research Contact may request information prior to the discussion, such as the proposed Specific Aims and an overview of the proposed research project. Staff Consultation: (1) ensures that NIDCR receives applications that are scientifically aligned with the institute’s mission and strategic vision, and (2) enables the institute to consider the budgetary impact of supporting such a project.

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Supporting Information

After Staff Consultation, the potential contact Principal Investigator must submit Supporting Information to NIDCR at least 5 weeks before the due date of the planned application. This Supporting Information serves as the formal request for NIDCR to accept primary assignment of an application with direct costs of $500,000 or more in any one year. The formal request may be submitted via one of the following:

  • Submit the request electronically (via email) through the applicant’s business office to the NIDCR Scientific/Research Contact with whom the Staff Consultation took place, or
  • Submit the request through eRA Commons, in the Prior Approval module.

For NIDCR to make an informed decision about whether to accept primary assignment of a proposed application, the Supporting Information must include the following:

  1. Intended NOFO and application due date.
  2. Name, institutional affiliation, email address, and telephone number of Principal Investigator(s). Names of all key personnel and participating institutions.
  3. An overview of the proposed research: Significance, specific aims, study design, sample size, overview of study procedures, and data to be collected/analyzed.
  4. Scientific justification for accepting the application; degree to which the proposed research represents a unique research opportunity; and/or addresses important knowledge gaps; compelling justification for the involvement of any foreign sites or collaborators, if permitted by the NOFO and applicable.
  5. Actual or estimated budget for the primary institution and each consortium (subcontract), including subcontract F&A (if any), for each project year of the proposed application. This information should be presented in tables and should include budget categories (key/senior and other personnel, equipment, travel, other direct costs), F&A (indirect costs), and total costs for each year of the requested application. In addition, budget justification for each budget category must be included.
  6. Justification for the size of the proposed budget in terms of the actual costs of the research.
  7. Documented attempts to contain the budget.
  8. Plans for addressing the NIH policies on data management and sharing and other resource sharing.
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Notification of NIDCR Decision

Within two to five weeks of receipt of the Supporting Information, NIDCR will notify the applicant via email about its decision to accept or decline assignment of an application.

Please note: NIDCR’s approval to accept primary assignment of an application does not guarantee funding. Funding decisions are made based on the outcome of scientific peer review, the scientific and technical merits of the application, programmatic priorities, and availability of funds.

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Submitting the Application

To facilitate receipt of the application, applicants should include a cover letter with the application stating that NIDCR has granted approval to accept primary assignment of the application and identifying the NIDCR program staff member(s) who communicated NIDCR’s approval to accept assignment. The total direct costs, less consortium F&A in the application, must not exceed the amount NIDCR agreed to accept. 

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Last Reviewed
April 2025