Key Dates

Related Announcements

This guidance applies to the Notices of Funding Opportunities below and all of their subsequent released equivalents:

• July 12, 2023 - PHS 2023-2 Omnibus Solicitation of the NIH, CDC and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed). See NOFO PA-23-230.
• July 12, 2023 - PHS 2023-2 Omnibus Solicitation of the NIH and CDC for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Required). See NOFO PA-23-231.
• July 12, 2023 - PHS 2023-2 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Not Allowed). See NOFO PA-23-232. 
• July 12, 2023 - PHS 2023-2 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Required). See NOFO PA-23-233.
• December 20, 2022 - NHLBI Announces New Policies Regarding Budget Guidelines for SBIR/STTR Applications – Rescinded. See NOT NOT-HL-22-036.
• December 20, 2022 - NHLBI Announces New Policies Regarding Budget Guidelines for SBIR/STTR Applications – Rescinded. See NOT NOT-HL-22-065.

Issued by

National Heart, Lung, and Blood Institute (NHLBI)

Purpose

The information in this Notice supersedes information contained in NOT-HL-22-036 and NOT-HL-22-065.

The purpose of this notice is to inform potential applicants of the new National Heart, Lung, and Blood Institute (NHLBI) SBIR/STTR programs policies regarding total funding support (i.e., the sum of direct costs, indirect costs, and fee) for grant applications that exceed the NIH-wide budget guidelines set by the U.S. Small Business Administration (SBA). The current NIH-wide budget guidelines for the SBIR and STTR programs may be found at https://seed.nih.gov/small-business-funding/small-business-program-basics/understanding-sbir-sttr#Budget-and-timelines-for-funding.

NIH has received a waiver from the SBA to exceed the above NIH-wide budget guidance for specific topics. The NHLBI will consider funding applications beyond the above-mentioned guidance if they address the SBA-approved waiver topics. The current list of NHLBI SBA-approved topics may be found at:

https://seed.nih.gov/sites/default/files/HHS_Topics_for_Budget_Waivers.pdf. It is strongly recommended for applicants who have a project that falls under one of the SBA-Approved Waiver Topics to reference the corresponding topic in their Budget Justification document.

For most projects falling under one of the SBA-approved waiver topics, the NHLBI does not generally fund applications with budgets that exceed the current SBA-mandated NIH budget guidelines. However, the NHLBI may occasionally consider funding projects above these guidelines for proposals with strong justifications and falling under one of the approved waiver topics. In addition, the proposals should fulfill one or more of the following criteria:

1. The application involves the clinical testing of therapeutics, devices, imaging agents, biologics, diagnostics, clinical and rehabilitation tools, and/or technologies.
2. The application involves the use of a large animal model. For the purpose of this notice, large animal model species include: swine (porcine), sheep (ovine), cattle (bovine), cat (feline), dog (canine), ferret, and nonhuman primates.

Applicants with budget requests exceeding the SBA caps should be prepared to negotiate their budget down if their proposal does not fall into one of the above categories. Furthermore, all applicants with budget questions or considering requesting a budget greater than the current NIH-wide budget guidelines are strongly encouraged to contact the NHLBI SBIR office at nhlbi_sbir@mail.nih.gov at least one month prior to applying.

Inquiries

Please direct all inquiries to:

Stephanie Davis, Ph.D.
National Heart Lung and Blood Institute (NHLBI)
Telephone: 301-496-8412
Email: NHLBI_SBIR@mail.nih.gov