NOT-HL-22-065 - NHLBI Announces New Policies Regarding Budget Guidelines for SBIR/STTR Applications

PA-22-176 - PHS 2022-2 Omnibus Solicitation of the NIH, CDC and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed)
PA-22-177 - PHS 2022-2 Omnibus Solicitation of the NIH and CDC for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Required)
PA-22-178 - PHS 2022-2 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Not Allowed)
PA-22-179 - PHS 2022-2 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Required)

Issued by

National Heart, Lung, and Blood Institute (NHLBI)

Purpose

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 guidance ($275,766 for Phase I awards and $1,838,436 for Phase II awards, respectively).

NIH has received a waiver from the Small Business Administration (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. Applications that address the SBA-approved waiver topics may request budgets up to $300,000 total costs for a Phase I (R41/R43) application or up to $2,000,000 total costs for a Phase II (R42/R44) application. 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

Additionally, the NHLBI may consider Phase I budgets above $300,000 total costs or Phase II budgets above $2,000,000 total costs if they address the NHLBI waiver topics, include strong scientific justification to exceed the NIH-wide budget guidance, and one or more of the following criteria have been fulfilled:

1. The application involves the clinical testing of therapeutics, devices, imaging agents, biologics, diagnostics, clinical and rehabilitation tools, and/or technologies for clinical research.
2. The application involves the use of a large mammalian species as an 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.

All applicants requesting a budget with total costs greater than $300,000 for Phase I (R41/R43) or $2,000,000 for Phase II (R42/R44) should be prepared to negotiate their budget down if needed. Furthermore, all applicants with budget questions or considering requesting a budget greater than the set budget limitation amounts are strongly encouraged to contact the NHLBI SBIR office at http://bit.ly/ContactNHLBIsbir at least one month prior to submitting an application.

Inquiries

Please direct all inquiries regarding this Notice to:

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