Revised: August 27, 2019
This document describes the National Heart, Lung, and Blood Institute (NHLBI) implementation of the NIH policy requiring all investigator-initiated applications that request $500,000 or more in direct costs in any one year to obtain documented approval from the Institute stating that it will accept the application for initial peer review.
This policy applies to all investigator-initiated new, renewal (competing continuation), resubmission (amended), or revision (competing supplement) applications requesting $500,000 or more in direct costs in any one year. First-tier consortium and administrative (F&A) costs do not count against the direct cost limit.
Prospective applicants should always refer to Section IV (Application and Submission Information) of the individual Funding Opportunity Announcement (FOA) to which they are responding for detailed information about applications requesting $500,000 or more in direct costs in any project year. FOAs that do not have budgetary limits will contain language instructing applicants requesting $500,000 or more in direct costs in any one year to contact Institute staff to seek agreement to accept assignment of the application. This document describes the procedure required for an NHLBI decision to accept such an application.
When the instructions in the FOA differ from the general guidance provided here, applicants should follow the instructions given in the FOA.
This policy does not apply to:
Note: The requirements and criteria for acceptance of National Research Service Award (NRSA) Institutional Research Training (T32) applications requesting $500,000 or more in direct costs for any year differ from what is described in this policy; please refer to the NHLBI Supplemental Guidelines for the Ruth L. Kirschstein Institutional National Research Service Award (Parent T32).
To obtain NHLBI acceptance for review of an application requesting direct costs of $500,000 or more in any one year, a potential applicant must:
Important: Please see Table 1. Pre-submission milestones in section D. for the deadlines associated with the staff consultation and letter of request.
The staff consultation is the first step in requesting approval to submit an application with direct costs of $500,000 or more in any one year. It is a discussion between Institute staff members and the Principal Investigator (PI) and key personnel of a proposed research project (to adequately prepare for this discussion, NHLBI staff members may request a draft letter of request prior to the staff consultation). The staff consultation: (1) ensures that the NHLBI 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.
After the staff consultation, the intended applicant(s) submit a letter of request (as a PDF attached to an email) to the Director of the NHLBI extramural Program Division whose research mission is most relevant to the proposed topic (see Section E. below). This letter serves as the formal request seeking permission to submit an application with direct costs of $500,000 or more in any one year.
In order for the NHLBI to make an informed decision about whether to accept a proposed application for initial peer review, the letter of request should be approximately five pages and include:
*Proposed third-party support: A letter notifying the NHLBI about any proposed third-party support, the estimated commitment level, and possible contingency plans in the event that the third-party support is terminated during the research project should be submitted by the PI at the same time as the $500K letter of request. This letter is non-binding and is for planning purposes only. If the NHLBI decides to fund the application, prior to the Notice of Award the NHLBI will request that the grant applicant’s Authorized Organization Representative (AOR) submit a formal Third-Party Contribution Agreement signed by the third-party’s AOR. In addition, NHLBI funding of an application with third-party support may be contingent on securing co-funding from those sources.
The NHLBI considers the following criteria in determining whether to accept a proposed application for initial peer review:
For research involving human subjects, the NHLBI considers the following additional criteria:
Within two to six weeks of receipt of the letter of request, the NHLBI will notify the applicant in writing about its decision to accept or reject an application for peer review.
Please note: Granting permission to submit the application for review does not guarantee the NHLBI will fund the application or that it will fund the application at the requested levels, regardless of the outcome of peer review.
To facilitate the receipt of the application, applicants must include a cover letter with the application that identifies the NHLBI Program staff member(s) with whom they have been in contact regarding the application. If the Subtotal Direct Cost on the cover page of the application exceeds the amount the NHLBI agreed to accept, the application may be withdrawn or not awarded.
The NHLBI’s decision to accept a $500K application for peer review for a specific receipt date automatically allows for the submission a single amended application (i.e., an “A1” application), provided that
Contingent on meeting the three requirements above, an applicant intending to submit an amended (A1) application does not need to participate in another staff consultation or submit another letter of request. However, the NHLBI requests that every applicant intending to submit an A1 application first submit a letter of intent to the NHLBI so the Institute can plan for the receipt, referral, and review of the A1 application. See the “Note” below for specific instructions.
The applicant must initiate a new round of discussions with Institute staff (i.e., a staff consultation) and submit a new letter of request if:
A resubmission (A1) application does not meet all three conditions above, OR
The resubmission (A1) application proposes to add an ESI-led subproject when the initial new (A0) application did not, and the budget increases
If a resubmission (A1) application does not meet all three conditions above, the applicant must initiate a new round of discussions with Institute staff (i.e., a staff consultation) and submit a new letter of request.
Note: NIH policy requires documented Institute permission for every submission of an application with subtotal directs costs equal to or exceeding $500,000 in any one year, and NHLBI staff members need to take administrative actions so the Center for Scientific Review can accept a resubmission (A1) application for peer review. Therefore, applicants must inform NHLBI staff about the intended receipt date to which they plan to submit the resubmission (A1) application. The most effective and preferred method to notify staff about the intended submission of an amended (A1) application is through a letter of intent to the appropriate Program Officer, with a separate copy to the Director, Office of Scientific Review, at least six weeks prior to submitting any resubmission application. This letter should include:
In the event the resubmission (A1) application is not awarded, applicants may submit a new (A0) application with similar science, in accordance with the NIH application submission policy as stated in NIH Guide Notice NOT-OD-14-074. If the new application requests direct costs of $500,000 or more in any one year, then the $500K process for new applications applies and must be re-initiated (even if the subsequent new [A0] application has the same science and budget as an earlier $500K application the NHLBI agreed to accept but that was unsuccessful).
Potential applicants are strongly encouraged to begin informal discussions with NHLBI scientific staff as early as possible in the process of planning their proposed research application (remember that staff consultations are always required before applicants may submit letters of request). The deadlines for the two steps associated with obtaining NHLBI acceptance of an application for review depend on whether the direct costs requested exceed the program project grant (PPG) cap in any one year.
*For proposed applications that include non-NIH support (i.e., cash, goods, services, in-kind contributions, salary support): If the value of the non-NIH support plus the subtotal direct costs requested of the NIH (excluding subcontract F&A) exceeds program project grant (PPG) cap in any one year, the deadlines for applications requesting direct costs exceeding the PPG cap apply. (Calculate this in one of the two tables provided for the letter of request:
For new or renewal applications requesting direct costs exceeding the PPG cap any one year:
For new or renewal applications requesting direct costs less than the PPG cap (but $500,000 or more) in any one year:
Use the table below to find specific deadlines associated with each receipt date:
Table 1: Pre-submission milestones
|NEW or RENEWAL applications requesting direct costs EXCEEDING the PPG budget cap in any one year|| NEW or RENEWAL applications requesting direct costs LESS THAN the PPG budget cap
(but ≥ $500K) in any one year
|Cycle I: October Council||Cycle III: May Council||Cycle I: October Council||Cycle II: January Council||Cycle III: May Council|
|Application Receipt Date**||
Jan. 25 – Feb. 5
|Sept. 25 – Oct. 5
|Jan. 25 - Feb. 5
|May 25 - June 5
|Sept. 25 – Oct. 5
|Letter of Request Deadline||Nov. 15||May 15||Dec 14
|Staff Consultation Completed||Oct. 18||April 17||Nov 25
(earlier contact recommended)
(earlier contact recommended)
(earlier contact recommended)
|Letter of Intent for Resubmission (A1) Applications Requested||Six weeks prior to receipt date|
** The application receipt dates are staggered for various grant mechanisms. In the “Application Receipt Date” row of the table above, the earlier date is for all P01s (where applicable). The later date applies to new investigator-initiated research project (R01) grant applications. Dates in italics are for renewal R01 applications.
Application receipt dates for other grant mechanisms – as well as for renewal, resubmission, and revision submissions – can be found on the “Standard Due Dates for Competing Applications” website at http://grants1.nih.gov/grants/funding/submissionschedule.htm. The deadlines for the milestones dates in the table (e.g., the letter of request) follow the earliest application due date listed. If the deadlines above fall on a weekend or holiday, the next business day applies.
For applications to be submitted for the AIDS receipt dates, the deadlines for the pre-submission milestones follow the standard schedule (i.e., the letter of request deadline is six weeks prior to submission date and the deadline for completing the staff consultation is two months prior to the AIDS receipt date).
All written requests for NHLBI agreement to accept applications subject to this policy should be submitted to one of the following Division Directors:
Dr. James Kiley
6705 Rockledge Drive, Room 405-B, MSC 7952
Bethesda, MD 20892-7952
Dr. W. Keith Hoots
6705 Rockledge Drive, Room 408-R, MSC 7950
Bethesda, MD 20892-7950
Dr. David Goff
6705 Rockledge Drive, Room 309-R
Bethesda, MD 20892-7940
Dr. George Mensah
Rockledge One, Room 402-K
6705 Rockledge Drive
Bethesda, MD 20817
Q1: How are the NHLBI timelines for the staff consultation, letter of request, and (resubmission application) letter of intent affected by applications eligible for submission under the NIH Policy on Late Submission of Grant Applications?
A1: The NHLBI expects applicants to adhere to the deadlines specified in this policy as they apply to the cycle for the Council to which an application is to be submitted. Given extenuating circumstances, staff members may grant latitude on these deadlines--not to exceed two weeks for applications submitted to standard receipt dates or one week for applications submitted to expedited receipt dates (e.g., AIDS receipt dates).
Q2: How are the NHLBI timelines for the staff consultation, letter of request, and (resubmission application) letter of intent affected by applications eligible for submission under the NIH continuous submission policy?
A2: Applications requesting direct costs of $500,000 or more in any year and that are less than PPG cap that are eligible for submission under the NIH continuous submission policy, may have their deadlines adjusted as described here:
It is expected that applications requesting direct costs that exceed the PPG cap in any one year and are eligible for submission under the NIH continuous submission policy will adhere to the pre-submission activity (letter of request and staff consultation) and approval schedule as stated in the pre-submission milestones table (Table 1) above. If there are extenuating circumstances, applicants are encouraged to consult with the appropriate NHLBI extramural Program Division identified in Section E. of this policy.