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 8, 2004

1. Purpose of This Document
   
   This document outlines National Heart, Lung, and Blood Institute (NHLBI) policy and procedures for complying with the NIH policy regarding acceptance of grant applications that request direct costs of $500,000 or more in any year. It is intended to formalize and standardize the process to ensure that all investigator requests for acceptance of such applications are handled in a consistent and timely manner. Obtaining NHLBI agreement to accept an application is only the first step in the process of applying for funding; as with all grant applications, the ultimate decision regarding funding is dependent upon the results of peer review for technical/scientific merit and subsequent action by the National Heart, Lung, and Blood Advisory Council.
   
   
2. The NIH Policy

   In May 1996, the NIH Guide included an announcement of a new NIH-wide policy regarding acceptance of unsolicited grant applications requesting direct costs of $500,000 in any given year. The policy provided that:

   "An applicant planning to submit a new (Type 1) investigator-initiated grant application requesting $500,000 or more in direct costs for any year ... must contact Institute or Center program staff before submitting the application ... The applicant must obtain agreement from Institute/Center staff that the Institute or Center will accept the application for consideration for award ... The applicant must identify, in the cover letter that is sent with the application, the staff member and Institute or Center who agreed to accept assignment of the application."

   The same Guide announcement made clear that the policy applies to "... a group of applications, such as those for clinical trial networks, meeting the threshold in the aggregate even if no single application in the group requests that much."

   A subsequent NIH Guide notice in March 1998 extended the policy to cover all unsolicited grant applications, i.e., "new (Type 1), competing continuation (Type 2), competing supplement and any amended/revised version of the preceding grant application types requesting $500,000 or more in direct costs for any year."

   Applicable Mechanisms

   The NIH policy applies to all unsolicited research or research training grant applications and applications submitted in response to program announcements for any mechanism (e.g., R01, P01, R18, T32) that request $500,000 or more in direct costs for any one year. An Institute may, however, choose to exclude certain classes of applications from this requirement.

   Exclusions

   This policy does not apply to applications submitted in response to Requests For Applications or to the Omnibus Solicitations for Small Business Innovation Research (SBIR) or Small Business Technology Transfer (STTR).

   In addition, the initial application for any renewal of a Program Project Grant and the single allowed amendment for that same application are exempt from this requirement.
   
   

3. Requests from Investigators

   To ensure full and fair consideration of all investigator requests for NHLBI acceptance of applications subject to this policy, the NHLBI requires that requests for acceptance be submitted as a complete package in writing to the Director of the Division most relevant to the proposed research. The request should generally be no longer than 5 pages but must provide sufficient information about the specific aims of the research (including subprojects), the significance and/or potential impact on public health or health care of the research, annual and total direct costs and total costs, and key investigators to enable the Institute to make an informed decision about whether or not to accept a proposed application. The NHLBI does not count Facilities and Administrative (F&A) costs on consortia against the $500,000 direct cost cap.

   If the proposed research has the potential for immediate public health applicability, the Institute requires inclusion of a specific plan for disseminating results of the research to clinical and/or public health practice. The dissemination plan should include a brief description of the audience(s) most suitable for the research results, activities designed to reach that audience, a timeline, and a budget. Although most plans should be finalized and implemented in the last year of requested funding, implementation activities may extend one year beyond the award as a no-additional-cost extension. The quality of the dissemination plan will constitute an important consideration for the NHLBI in making funding decisions.

   The Institute recognizes that a request will often be preceded by informal discussions with NHLBI scientific staff regarding the proposed research; however, no official action will be taken until the request, in the form of a complete package as described above is received by the appropriate Division Director.

   Requests 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. The NHLBI will respond to all such requests by letter. If the decision is positive, the letter must be included as a cover letter with the application upon its submission to the Center for Scientific Review (CSR). Without the letter, the application will be returned to the applicant. The NHLBI will not intercede on behalf of any applicant who does not include the cover letter with an application.

   If an initial (i.e., unamended) application with direct costs of $500,000 or more in any one year is accepted but not funded, the NHLBI will accept one amendment to the application for review. Institute acceptance of the single amended application is encompassed in its acceptance of the initial application--no second request need be submitted provided the proposed aims and total direct costs remain unchanged. However, under no circumstances will the NHLBI accept a twice-amended application (i.e., an "A2" application) with direct costs of $500,000 or more in any given year, even if the initial and/or first amended (i.e., "A1") application did not have direct costs greater than $500,000 in any one year.

4. Timing of Submission of Requests from Investigators

   Beginning October 1, 2005, 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 (http://www.nhlbi.nih.gov/funding/policies/grantcaps.htm) for limits) will only be considered by the NHLBI once a year. Full and complete requests, including budgetary Information, must be received by the Institute by November 15 to be considered.

   Requests to submit:

   • competing continuation applications with direct costs that are greater than $500,000 in one or more years
   • new applications with direct costs that are 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.

5. Institute Processing of Requests
   
   
   1. The following criteria will constitute the basis for Institute decisions regarding acceptance of applications other than training grants:
      
      
      1. The proposed research is relevant to the NHLBI mission.
         
         
      2. The proposed research complements ongoing program activities of the Institute and is likely to have a positive impact on program balance.
         
         
      3. The results of the proposed research will provide a valuable addition to the existing knowledge base.
         
         
      4. For all proposed research involving human subjects: (i) the outcome will have public health applicability, and (ii) the investigator's dissemination plan is adequate.
         
         
      5. The annual costs for each year of support for the proposed research are reasonable.
         
         
      6. For clinical research, study population plans comply with the NIH Policy on Inclusion of Women and Minorities as Subjects in Clinical Research and the NIH Policy in Inclusion of Children as Participants in Research Involving Human Subjects.

      For all phase III clinical trials, the following additional criteria will also apply:

      7. Plans exist for a data and safety monitoring board.
         
         
      8. Plans exist for submission of at least two applications, one of which is for the support of a data coordinating center (DCC). The principal investigator for the DCC cannot be involved in (and cannot be a principal investigator on) any other award associated with the trial.
         
         
   2. The following three criteria will constitute the basis for Institute decisions regarding acceptance of applications for training grants:
      1. The proposed research training is relevant to the NHLBI mission.
         
         
      2. The proposed research training complements ongoing program activities of the Institute and is likely to have a positive impact on program balance.
         
         
      3. The annual costs for each year of support for the proposed application are reasonable in terms of the prior training record of the faculty involved and, for competing renewals, the trainee slots for which funds have been provided have been utilized fully or nearly so, and unobligated balances reported have not been large.
         
         
   3. A response will be sent to the requester within 2 to 6 weeks after the receipt of the complete package of information on the proposed application described in paragraph one of Item C, herein. This response, if affirmative, must be submitted with the application upon its submission to the Center for Scientific Review (CSR). If it is not, then CSR will return the application and NHLBI will not intercede with CSR on the applicant's behalf.
      
      
   4. The NHLBI will report in closed session at each meeting of the National Heart, Lung, and Blood Advisory Council the actions taken on all requests submitted in compliance with the NIH policy since the previous meeting of the Council.

6. 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 Heart and Vascular Diseases

Dr. Stephen C. Mockrin
NHLBI/DHVD
Two Rockledge Center, Room 9160
6701 Rockledge Drive, MSC 7940
Bethesda, MD 20892-7940
Phone: 301-435-0466
Fax: 301-480-7971
Email: mockrins@nhlbi.nih.gov

Division of Lung Diseases

Dr. James Kiley
NHLBI/DLD
Two Rockledge Center, Room 10018
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. Charles Peterson
NHLBI/DBDR
Two Rockledge Center, Room 10161
6701 Rockledge Drive, MSC 7950
Bethesda, MD 20892-7950
Phone: 301-435-0080
Fax: 301-480-0867
Email: petersoc@nhlbi.nih.gov

Division of Epidemiology and Clinical Applications

Dr. Peter Savage
NHLBI/DECA
Two Rockledge Center, Room 8100
6701 Rockledge Drive, MSC 7938
Bethesda, MD 20892-7938
Phone: 301-435-0422
Fax: 301-480-1864
Email: savagep@nhlbi.nih.gov