Applications with Direct Costs of
$500,000 or more in any one year

National Heart, Lung, and Blood Institute
National Institutes of Health

Revised: May 8, 2011

A. Purpose

This document describes the National Heart, Lung, and Blood Institute (NHLBI) implementation of the NIH policy requiring all applications that request $500,000 or more in direct costs in any year to be accompanied by a letter from the Institute stating that it will accept the application.

B. Scope

This policy applies to any investigator-initiated new, renewal (competing continuation), resubmission (amended), or revision (competing supplement) application requesting $500,000 or more in direct costs in any year. First-tier consortium or contractual facilities and administrative (F&A) costs do not count against the direct cost limit.

Additional policies apply to program project grant applications. (See http://www.nhlbi.nih.gov/funding/policies/ppg.htm).

Additional policies apply to Phase III clinical trial grant applications. (See http://www.nhlbi.nih.gov/funding/policies/clinical.htm).

Additional policies apply to multiple PI grant applications. (See http://grants.nih.gov/grants/multi_pi/overview.htm#format).

Additional policies apply to resource-related research (R24) grant applications. (See http://www.nhlbi.nih.gov/funding/policies/r24.htm).

Additional policies apply to research training (T32, T35) applications. (See http://www.nhlbi.nih.gov/funding/policies/t32/index.htm).

Additional policies apply to program project grant applications in response to PAR-09-185: "Translational Programs in Lung Diseases (P01)." (See http://grants.nih.gov/grants/guide/pa-files/PAR-09-185.html).

C. Definitions

In the process of submitting an application with direct costs greater than $500,000 in any given year, three letters are generated and are defined below.

The initial letter generated is the letter of request, which is submitted by the Principal Investigator (PI) to the Director of the NHLBI extramural program Division whose research mission is most relevant to the proposed topic. The purpose of this letter is to request permission to submit an application with direct costs greater than $500,000 in any given year.

A letter of acceptance may be received by the PI from the Director of the NHLBI extramural program Division whose research mission is most relevant to the proposed topic. This letter giving the PI permission to submit the application is generated after the PI has had discussions with program and review staff and after a letter of request to submit an application with direct costs greater than $500,000 in any given year has been received by NHLBI. A letter of acceptance must accompany every submission of an application with direct costs greater than $500,000 in any given year. The letter of acceptance is valid for two years from the date approved by NHLBI.

A letter of intent is submitted by the PI to an appropriate Program Officer and the Director, Office of Scientific Review prior to the submission of a resubmission application. The letter conveys basic information regarding the application and allows NHLBI and CSR to plan for receipt, referral, and review of the application.

D. Exclusions

This policy does not apply to:

• Small Business Innovation Research (SBIR) grant applications [R43 or R44]
• Small Business Technology Transfer (STTR) grant applications [R41 or R42]
• program project grant renewal (competing continuation) or resubmission (amended) applications [P01]
• applications submitted in response to a Funding Opportunity Announcement (FOA) that includes specific budgetary limits. [FOAs that do not have budgetary limits will contain language instructing the applicants to follow the procedures for applications greater than $500,000 or more in direct costs in any one year.]

E. Timing of Submission of Requests from Investigators

The timing of letters of request seeking permission to submit grant applications of $500,000 or more in any year varies with the amount of money requested:

• If the amount requested in any year in a new grant application is in excess of the program project grant cap, then requests to submit must be made by two specific deadlines in each calendar year (see paragraph 1 below for more details).
• If the amount requested in any year in a renewal grant application is in excess of the program project grant cap, then requests to submit may be made at any time during the year (see paragraph 2 below for more details).
• If the amount requested in any year in a new grant application is less than or equal to the program project grant cap, then requests to submit may be made at any time during the year (see paragraph 2 below for more details).

It is NHLBI policy that requests to submit new applications with direct costs in excess of the allowable requested direct cost for program project grants in any year (see Allowable Requested Direct Costs For Program Projects for limits) will be considered by the NHLBI twice a year. Full and complete requests, including budgetary information, must be received by the Institute by November 15th to be considered for submission for the following February 5th receipt date or by May 15th to be considered for submission for the following October 5th receipt date. The application receipt dates shown below only apply to regular research project (R01) grant applications. Receipt dates for other grant mechanisms can be found at the “Standard Due Dates for Competing Applications” Web site at the following link: http://grants1.nih.gov/grants/funding/submissionschedule.htm.

Requests to submit:

• competing continuation applications with direct costs that are equal to or greater than $500,000 in one or more years
• new applications with direct costs that are equal to or greater than $500,000 in one or more years but do not exceed the allowable requested direct cost for program project grants in any year

will be considered by the NHLBI at any time, subject only to the requirement noted above that a request must be received by the NHLBI no later than 6 weeks prior to the standard NIH receipt date for which a proposed application would be submitted.

F. Procedures

Individuals interested in submitting an application covered by these guidelines are strongly encouraged to begin informal discussions with NHLBI scientific staff as early as possible in the process of planning their research application.

To obtain NHLBI acceptance of an application, an applicant must:

• discuss the proposed research project with NHLBI program and review staff via an in person meeting or a conference call
• submit a letter of request to the NHLBI as described below in “Step 2”

If the NHLBI agrees to accept an application, it will issue an acceptance letter that must accompany the application.

The deadlines for the above steps depend on whether the direct costs requested are either [1] less than or equal to the program project grant (PPG) cap, or greater than the PPG cap:

• ≤ PPG cap. These are applications requesting $500,000 or more in direct costs in any year but less than or equal to the allowable direct costs for a PPG. See http://www.nhlbi.nih.gov/funding/policies/grantcaps.htm.
• > PPG cap. These are applications requesting more than the allowable direct costs for a PPG in any year.

IMPORTANT-- The NHLBI considers requests to submit applications > PPG cap twice each year. The submission schedule may be found at: http://grants.nih.gov/grants/funding/submissionschedule.htm

Step 1: NHLBI Staff Meeting  -- Required

Step 2: Letter of Request – Required

G. Acceptance Criteria

For all letters of request, the NHLBI considers the following criteria in determining whether to accept a proposed application:

• the proposed research is relevant to the NHLBI mission
• the proposed research complements NHLBI programs
• the proposed research will provide a valuable addition to existing knowledge
• the proposed annual costs are reasonable
• the proposed plan for data sharing are appropriate
• and for all proposed research involving human subjects, the following additional criteria:
  • the proposed research is applicable to public health
  • the proposed dissemination plan is adequate
  • the study population complies with:
    • NHLBI Policy for Inclusion of Women and Minorities as Subjects in Clinical Research
    • NIH Policy and Guidelines on the Inclusion of Children as Participants in Research Involving Human Subjects

Additional criteria apply to Phase III clinical trials. (See http://www.nhlbi.nih.gov/funding/policies/clinical.htm).

Additional criteria apply to research training (T32, T35) applications (see http://www.nhlbi.nih.gov/funding/policies/t32/index.htm).

H. Acceptance

Within two to six weeks of receipt of the request letter, NHLBI staff will inform the applicant whether or not to proceed with submission of the proposed application. The acceptance letter from the NHLBI must be included with the cover letter of the application. The NIH Center for Scientific Review will not accept the application without documentation of NHLBI permission to submit an application.

I. NHLBI Extramural Program Division Directors

All written requests for NHLBI agreement to accept applications subject to this policy are to be submitted to one of the following Division Directors:

Division of Lung Diseases

Dr. James Kiley
NHLBI/DLD
Two Rockledge Center, Room 10042
6701 Rockledge Drive, MSC 7952
Bethesda, MD 20892-7952
Phone: 301-435-0233
Fax: 301-480-3547
Email: kileyj@nhlbi.nih.gov

Division of Blood Diseases and Resources

Dr. W. Keith Hoots
NHLBI/DBDR
Two Rockledge Center
6701 Rockledge Drive, MSC 7950
Bethesda, MD 20892-7950
Phone: 301-435-0080
Fax: 301-480-0867
Email: hootswk@nhlbi.nih.gov

Division of Cardiovascular Sciences

Dr. Michael Lauer
NHLBI/DCVS
Two Rockledge Center, Room 8128
6701 Rockledge Drive, MSC 7940
Bethesda, MD 20892-7940
Phone: 301-435-0422
Fax: 301-480-7971
Email: lauerm@nhlbi.nih.gov

I. References

• http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html
• http://grants.nih.gov/grants/guide/notice-files/NOT-OD-05-004.html

Last Updated May 2012