Applications with Direct Costs of $500,000 or More in Any One Year

Revised: August 27, 2019

A. Purpose

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.

B. Scope

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:

• Small Business Innovation Research (SBIR) grant applications (R43 or R44)
• Small Business Technology Transfer (STTR) grant applications (R41 or R42)
• Applications submitted in response to Requests for Applications (RFAs) or in response to other Announcements that include specific Budgetary limits.

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).

C. Process

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:

1. Discuss the proposed research project with NHLBI program and review staff via an in-person meeting or a conference call (i.e., staff consultation)
2. Submit a letter of request to the NHLBI

Important: Please see Table 1. Pre-submission milestones in section D. for the deadlines associated with the staff consultation and letter of request.

Staff Consultation

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.

Letter of Request

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:

• The title of the proposed project
• The anticipated Funding Opportunity Announcement
• The anticipated application receipt date
• A description of the specific aims of the proposed project, including any subprojects
• The significance of the proposed research
• The key personnel (the eRA Commons userid must be included for the PI or contact PI)
• The submitting organization or institution
• The direct costs, subcontract F&A (if any), and total costs for each year of the proposed project using one of the two tables provided via the following link (funds and value of goods or services provided by third-party contributors* must also be included): 500K Budget Tables
• 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, and a timeline
• Plans for data sharing

*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.

Criteria for NHLBI Decision

The NHLBI considers the following criteria in determining whether to accept a proposed application for initial peer review:

• Relevance to the NHLBI mission and strategic vision
• Complementary nature of the proposed program to other NHLBI programs
• Potential value of knowledge gained
• Reasonableness of the proposed annual costs
• Appropriateness of the proposed plans for data sharing
• Potential for cost sharing with other federal and non-federal entities

For research involving human subjects, the NHLBI considers the following additional criteria:

• Applicability to public health
• Adequacy of the dissemination plan
• Compliance of the proposed study 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

Notification of NHLBI Decision

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.

Submitting the Application

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.

Instructions for Resubmission (Amended) Applications

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

1. the submission of the A1 application occurs within 37 months of the original receipt date for the initial new (A0) application, in accordance with NOT-OD-10-140,
2. the originally proposed research plan remains unchanged, and
3. the total direct costs per year do not exceed the amount the NHLBI originally agreed to accept (excluding increases in PI salaries due to changes to the NIH salary cap, if the new budget does not exceed the program project grant (PPG) cap of $1.515 million in direct costs in any one year). PPG applications including an Early Stage Investigator (ESI) as a Project Leader may have budget cap of up to $1.765 million per year if at least four projects are included in the application.

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:

• Receipt date and Council round for the intended submission
• Descriptive title of proposed research
• Name, address, and telephone number of the PI
• Names of other key personnel
• Participating institutions (highlight the name of the submitting institution)
• Number and title of the FOA to which the application is responding
• Prior grant application number
• eRA Commons userid of the PI or the contact PI

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).

D. Timing

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:

500K Budget Tables

For new or renewal applications requesting direct costs exceeding the PPG cap any one year:

• the letter of request and staff consultation due dates (stated in Table 1 below) are firm because the NHLBI only considers requests to submit these applications twice per year.

For new or renewal applications requesting direct costs less than the PPG cap (but $500,000 or more) in any one year:

• the letter of request must be received by the NHLBI no later than six weeks prior to the standard NIH due date for which a proposed application would be submitted, and
• the staff consultation should occur at least two months prior to the standard NIH application receipt date so NHLBI staff members can adequately consider the proposed project.

Use the table below to find specific deadlines associated with each receipt date:

Table 1: Pre-submission milestones

** 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).

E. NHLBI Extramural Program Division Directors

Division of Lung Diseases

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
NHLBI/DLD
6705 Rockledge Drive, Room 405-B, 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
6705 Rockledge Drive, Room 408-R, MSC 7950
Bethesda, MD 20892-7950
Phone: 301-435-0080
Fax: 301-480-0867
Email: hootswk@nhlbi.nih.gov

Division of Cardiovascular Sciences

Dr. David Goff
NHLBI/DCVS
6705 Rockledge Drive, Room 309-R
Bethesda, MD 20892-7940
Phone: 301-435-0422
Email: NHLBI_DCVS500k@mail.nih.gov

Center for Translation Research and  Implementation Science

Dr. George Mensah
NHLBI/CTRIS
Rockledge One, Room 402-K
6705 Rockledge Drive
Bethesda, MD 20817
Phone: 301-496-1051
Fax: 301-402-1051
Email: george.mensah@nih.gov

F. Frequently Asked Questions

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:

• Staff consultation: Two months prior to intended submission date
• Letter of request: Six weeks prior to intended submission date
• Letter of Intent for resubmission (A1) applications: Requested six weeks prior to submission date

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.

G. References and Resources

Templates

• 500K Budget Tables: Download (for inclusion in the required letter of request)

Policies and Guidance

• Notice of Intent to Publish a Funding Opportunity Announcement for NHLBI Program Project Applications (P01) (NIH Guide Notice NOT-HL-17-529)
• Revised Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs (NIH Guide Notice NOT-OD-02-004)
• NIH Announces Revised Policy: Applications that Include Consortium/Contractual Facilities and Administrative Costs (NIH Guide Notice NOT-OD-05-004)
• New Time Limit for NIH Resubmission Applications (NIH Guide Notice NOT-OD-10-140)
• NIH and AHRQ Announce Updated Policy for Application Submission (NIH Guide Notice NOT-OD-14-074)
• NIH Standard Due Dates for Competing Applications
• NIH Policy on Late Submission of Grant Applications (NIH Guide Notice NOT-OD-11-035)
• Change in the NIH Continuous Submission Policy (NIH Guide Notice NOT-OD-17-042)
• Frequently Asked Questions – Continuous Submission
• NIH Salary Cap Summary
• NHLBI Allowable Requested Direct Costs for Program Projects
• NHLBI Policy for Data Sharing from Clinical Trials and Epidemiological Studies
• NHLBI Supplemental Guidelines for the Ruth L. Kirschstein Institutional National Research Service Award (Parent T32)