To help the Institute manage the average costs of research project 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 (or P01 applications requesting $750,000 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 those responding to an RFA.

NIH Policy

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 is provided regarding applications that include Facilities and Administrative (F & A) costs, at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-05-004.html. Applications requesting a budget of $500,000 direct costs or more for any year continue to require prior approval from Institute/Center staff; however this limit is now exclusive of any consortium F&A costs.

The policy requires that "if the Institute or Center is willing to accept assignment of the application for consideration of funding, the staff will notify the Center for Scientific Review (CSR) before the application is submitted." That is, a request to accept the application (ARA form) must be submitted to CSR by the Institute/Center before the application is submitted. To meet this requirement, both the PI and the Institute must address the approval process well in advance of the planned submission date. As indicated in NOT-OD-02-004, the applicant must contact NIH staff no later than 6 weeks prior to the submission date.

NICHD Policy

(1) For the purpose of this policy, "large grant applications" are defined as applications requesting $500,000 or more ($750,000 or more for P01s) in direct costs in any year.

A request by Program Staff to the NICHD Office of Extramural Policy (OEP) 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.

(2) The NIH policy will be adhered to fully by NICHD. A request to accept a large grant application will be considered by the OEP, 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 receipt date. Furthermore, a large grant application will be accepted by NICHD only if: (1) it is submitted to CSR with the required cover letter identifying the staff member and Institute who agreed to accept assignment of the application, and (2) NICHD has approved acceptance of the application and formally notified CSR that NICHD is willing to accept the application for review, prior to application receipt. CSR will return any large grant application not meeting these published requirements. Only under extraordinary circumstances will an ARA be processed after an application for a large grant has been received by CSR.

(3) 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 submission 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 request to waive policy.
  
• Review of request and recommendation by NICHD Large Grants Committee.
  
• Final decision by Director, NICHD Office of Extramural Policy.
  
• Notification of the PI of the decision by the NICHD Office of Extramural Policy.
  
• Submission to CSR of request for application acceptance/assignment 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; the concept of "grant-in-aid" should be remembered.
  
  
• Remind you of the NIH Data Sharing Policy requirements
  (http://grants2.nih.gov/grants/policy/data_sharing/).

Decisions to request acceptance of a large grant application will be made at the Branch level, not by the individual Program Officer.

In deciding to recommend acceptance of an application, the Program 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 Program Officer and Branch decide to request acceptance of an application, the Program Officer will submit a justification and other materials for review by the NICHD Large Grants Committee and the Office of Extramural Policy. Submission of the justification to the OEP by program staff will be viewed as a request for a waiver of the NICHD policy. Decisions to accept large grant applications are made on a case-by-case basis, taking several factors into account.

Please remember: Though 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 to waive the policy regarding acceptance of a large grant application submitted by the Program Officer must address the factors listed below. As a 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 be considered:

• Scientific justification for accepting the application, within the context of the
  Branch/Center/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 http://grants2.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 the submission date if acceptance is approved.

(2) The NICHD Large Grants Committee will convene on a regular basis to consider requests prior to each submission date. The committee will make recommendations regarding acceptance of applications on the basis of the criteria listed below.

(3) The following criteria will be used by the Large Grants Committee 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/Center/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.
  

Final decisions will be made by the Director, Office of Extramural Policy, and communicated to the PI by OEP.