Guidelines for
APPLICATIONS WITH DIRECT COSTS OF $500,000 OR MORE IN ANY ONE YEAR

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

Revised: July 2008

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.  Consortium or contractual facilities and administrative (F&A) costs do not count against the direct cost limit.

Amended Applications
NHLBI agreement to accept an application includes a statement that the Institute will automatically accept a single resubmission (amended) application (i.e., an “A1” application) provided that the proposed aims and total direct costs per year remain unchanged. 

The NHLBI will not accept a second resubmission application (i.e., an “A2” application) requesting $500,000 or more in direct costs in any year regardless of the direct costs requested in the previous submissions.

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

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

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

C. 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.]

D. Timing of Submission of Requests from Investigators

Beginning June 1, 2008, requests to submit new applications with direct costs that are greater than 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 January 5th receipt date or May 15th to be considered for submission for the following October 5th receipt date.

Request submitted to NHLBI	Application Receipt Date
November 15th	January 5th
May 15th	October 5th

 

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 continue to 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.

E. 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
≤ PPG cap:	no later than 10 weeks prior to grant submission due date
> PPG cap:	no later than October 18 (for the November 15 request date) or no later than April 17 (for the May 15 request date)
Potential applicants must discuss with NHLBI staff their proposal, either through an in-person meeting in Bethesda, Maryland or a conference call.  After initial discussions with an applicant, NHLBI staff will suggest whether a meeting or conference call is preferable.

 

Step 2: Letter of Request – Required
≤ PPG cap:	no later than 6 weeks prior to grant submission due date
> PPG cap:	no later than November 15 or May 15
Potential applicants must submit a letter requesting permission to submit an application addressed to the Director of the NHLBI extramural program Division whose research mission is most relevant to the proposed topic.  The NHLBI extramural program Divisions and their Directors are listed below. The letter of request enables NHLBI to make an informed decision about whether to accept a proposed application.  The letter of request should be no longer than 5 pages and must: describe the specific aims of the proposed research, including any subprojects indicate the significance of the proposed research list key personnel provide direct, contract F&A, and total costs for each year in one of the two tables provided below, (note that costs provided by third-party contributors must also be included):  500K Budget Tables provide a specific plan for disseminating the results for clinical or public health practice, including a brief description of the intended audience; approaches designed to reach that audience; a timeline, and a budget describe plans for data sharing   The letter of request may be submitted by regular mail, courier delivery, or as a PDF file attached to email.

F. 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 ongoing or new NHLBI programs
• the proposed research will provide a valuable addition to existing knowledge
• the proposed annual costs are reasonable
• the proposed plans for data sharing
• 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:
• NIH Policy and Guidelines on the 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).

For Training Applications (T32, T35) (see http://www.nhlbi.nih.gov/funding/policies/t32/index.htm
for further details):  The NHLBI considers the following criteria in determining whether to accept a proposed training grant application:

• the proposed training is relevant to the NHLBI mission
• the proposed training complements ongoing NHLBI programs
• the proposed annual costs are reasonable given the prior training record of the faculty involved and, for renewal (competing continuation) applications, on how many of the trainee slots for which funds have been provided have been used

G. 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.

H. 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 Cardiovascular Diseases

Dr. Sonia Skarlatos
NHLBI/DCVD
Two Rockledge Center, Room 8124
6701 Rockledge Drive, MSC 7940
Bethesda, MD 20892-7940
Phone: 301-435-0477
Fax: 301-480-7971
Email: skarlats@nhlbi.nih.gov

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. Susan Shurin (Acting)
NHLBI/DBDR
Two Rockledge Center
6701 Rockledge Drive, MSC 7950
Bethesda, MD 20892-7950
Phone: 301-435-0080
Fax: 301-480-0867
Email: petersoc@nhlbi.nih.gov

Division of Prevention and Population Sciences

Dr. Michael Lauer
NHLBI/DPPS
Two Rockledge Center, Room 10122
6701 Rockledge Drive, MSC 7936
Bethesda, MD 20892-7936
Phone: 301-435-0422
Fax: 301-480-1864
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