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

Key Dates

Release Date:

December 20, 2022

Related Announcements

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)
NOT-OD-23-016 - Notice of Change to Award Budget for PHS 2022-02 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) Grant Applications

NOT-HL-22-036 - NHLBI Announces New Policies Regarding Budget Guidelines for SBIR/STTR Applications - Rescinded

Issued by

National Heart, Lung, and Blood Institute (NHLBI)

Purpose

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

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 ($295,924 for Phase I awards and $1,972,828 for Phase II awards).

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