NICHD Policy Guidelines: Large Grants

To help the Institute manage the average costs of grants and control the impact of costs on paylines, discretionary funding opportunities, and success rates, we have created guidelines for accepting unsolicited applications requesting $500,000 or more in direct costs in any year. These policies apply to all grant mechanisms and all application types (including new, competing continuation, revised, and competing supplement applications), except for SBIR/STTR applications or Funding Opportunity Announcements where a specific budget cap is specified.

NIH Policy

For the purpose of this policy, "large grant applications" are defined as applications requesting $500,000 or more in direct costs in any year. The NIH policy regarding the acceptance of applications for large grants is available at http://grants2.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html. Additional guidance at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-05-004.html clarifies that the $500,000 limit is exclusive of any contract/consortium F&A costs.

NICHD Policy

It is the policy of NICHD that, as a rule, large grant applications will not be accepted for review. This policy applies to all large grant applications, including new, competing continuation, supplemental, and amended applications, except for SBIR/STTR applications or applications submitted in response to Funding Opportunity Announcements where a specific budget cap is specified.  In addition, applications for PAR-23-037 or other announcements soliciting research for the NICHD Multisite Clinical Research Network follow a different process outlined at https://www.nichd.nih.gov/health/clinical-research/clinical-trial-preapplication-process.

A request by Program Staff to accept a large grant application is considered a request for a waiver of this policy. A request for waiver of this policy is required for each submission of an application, even if such a request had been approved in the past for a previous submission.

Applicants who wish to submit a large grant application must contact NICHD staff no later than 6 weeks prior to the appropriate standard application due date. (This deadline for contacting staff also applies to applications eligible for “continuous submission” – i.e., 6 weeks before the application due date not the later date that the application may be submitted.) For projects that are complex or that are requesting very large budgets, applicants are strongly encouraged to contact staff even earlier.

A request to accept a large grant application will be considered by the NICHD, only after NICHD program staff have documented communication with the applicant about the planned application and proposed budget, sufficiently in advance of the targeted application due date. Only under extraordinary circumstances will a waiver be granted after an application for a large grant has been received by CSR.

Investigators planning to submit large grant applications are reminded that there is always an opportunity to contact NICHD very early in the planning process, not waiting until six weeks prior to submission. Program Officers are prepared to provide early feedback about the feasibility of considering such an application and the Institute will be able to make decisions early, allowing you to make adjustments as needed and/or reconsider the request without waiting until shortly before the application due date.

Structure of Decision Making Process

The internal NICHD process for consideration of requests to waive the NICHD policy on acceptance of large grant applications includes the following components:

  • Program Officer discussions of planned large grant application with PI.
  • Branch decision about submitting request to the Institute to accept a large grant application.
  • Submission to NICHD Office of Extramural Policy of a request to waive policy.
  • Notification of the PI of the Institute’s decision by the NICHD Office of Extramural Policy.
  • Submission to CSR of request for application acceptance/assignment by the NICHD Office of Extramural Policy when submission has been approved.

Program Responsibility

Program Officers and Branches will evaluate thoroughly all requests for the submission of a large grant application before deciding to request a waiver. One of the important responsibilities of program staff is program planning. This includes recommending the most effective use of federal funds by allocating research support among competing scientific areas and mechanisms of support. It is program staff's prerogative to determine that the submission of any large grant application is not appropriate and to decline any request for submission of such an application, eliminating unnecessary administrative burden and time-consuming activities by NICHD staff and principal investigators.

When contacted by you as a potential large grant applicant, the Program Officer will:

  • Consider the proposed science.
  • Work with you to determine whether the costs are justified and explore the possibility of reducing the scope of the proposed project and related budget request.
  • Encourage you to consider opportunities for co-funding.
  • Remind you of the NIH Data Sharing Policy requirements (https://grants.nih.gov/grants/policy/data_sharing/).

Decisions to recommend a waiver to accept a large grant application will be made at the Branch level, not by the individual Program Officer, and the decision to grant the waiver will be made at the Institute level.

In deciding to request a waiver to accept an application, the Branch will consider the following:

  • The proposed science in the context of the Branch, its scientific priorities, and the current grant portfolio in the area.
  • The Branch may also consider the level of your other research support, including support from NIH and from other sources, in making decisions about requesting acceptance of a large grant application.

If the Branch decides to request acceptance of an application, the Program Officer will submit a justification and other materials to the NICHD Office of Extramural Policy (OEP). Submission of the justification to the OEP by program staff will be viewed as a request for a waiver of the NICHD policy.

Please remember: Though individual program staff may recommend that the Institute accept the application for review, the actual decision to accept is made by the Institute.

NICHD Process and Requirements for Requesting Acceptance of a Large Grant Application

The justification for a request for a waiver to the policy regarding acceptance of a large grant application must address the factors listed below. As a Principal Investigator (PI), you should expect these issues to be discussed as you work with the Program Officer. These factors are the minimum points to be addressed, and others may also be considered:

  • Scientific justification for accepting the application, within the context of the
    Branch/NICHD scientific priorities and program needs. Degree to which the proposed research represents a unique research opportunity and/or addresses important knowledge gaps.
  • The actual or estimated budget (direct and total costs) that you intend to request for all years of the proposed grant. This information should be presented in a table; the Budget table from the application form is helpful, but not required.
  • Justification for the size of the proposed budget in terms of the actual costs of the research.
  • Documented attempts to contain the budget request and/or obtain co-funding.
  • Availability of (or potential for) collaborative funding.
  • Plans for addressing the NIH Policy on Data Sharing (see https://grants.nih.gov/grants/policy/data_sharing/).
  • Documentation of your understanding as PI that acceptance of the application for review does not guarantee that NICHD will fund the application or will fund it at the requested levels, regardless of the outcome of peer review.

Institute Processing of Program Requests to Accept a Large Grant Application

(1) The justification and supporting documentation must be submitted by Program to the OEP to allow sufficient time for the evaluation of the request and CSR notification prior to submission if acceptance is approved.

(2) The following criteria will be used by program staff to evaluate waivers for acceptance of large grant applications and constitute the basis for Institute decisions regarding acceptance of such applications:

  • There is a strong scientific justification for accepting the application, within the context of the Branch/NICHD scientific priorities and program needs.
  • The proposed research represents a unique research opportunity and/or addresses important knowledge gaps.
  • The projected costs for each year of support for the proposed research are reasonable and clearly justified.
  • The potential impact of the proposed grant on the Institute's ability to maintain reasonable funding of grants across all areas of the NICHD mission.
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