Key Dates

• November 16, 2021 - NHLBI SBIR Phase IIB Small Market Awards to Accelerate the Commercialization of Technologies for Heart, Lung, Blood, and Sleep Disorders and Diseases (R44 Clinical Trial Optional). See NOFO RFA-HL-23-008.

National Heart, Lung, and Blood Institute (NHLBI)

National Center for Advancing Translational Sciences (NCATS)

The Small Business Innovation Research (SBIR) Program is an important National Institutes of Health (NIH) funding mechanism used to develop innovative solutions that address public health challenges. A major objective of the SBIR Program is to facilitate the commercialization of technologies developed by small business concerns (SBCs). Yet, the development of biomedical products is often impeded by a significant funding gap between the end of the SBIR Phase II award and the commercialization stage. NHLBI anticipates issuing a notice of funding opportunity (NOFO) that will invite small businesses to submit SBIR grant applications to support later stage research and development (referred to as Phase IIB) for promising projects that were previously funded by SBIR or STTR (Small Business Technology Transfer) Phase II awards and which will require eventual Federal regulatory approval/clearance. The purpose of this anticipated NOFO and the resulting Phase IIB Small Market SBIR awards is to assist applicants in pursuing the milestone(s) necessary to advance a product to regulatory approval and commercialization by promoting partnerships between SBIR Phase II awardees and third-party investors and/or strategic partners. 

Phase IIB Small Market RFAs are specifically designed to support products that address rare diseases or products that are targeted at young pediatric populations. This intended NOFO will specifically be intended to benefit clinical practice by accelerating the commercialization of novel products that require ultimate approval/clearance by the FDA. Competitive preference and funding priority is expected to be given to applications deemed likely to result in a clinically-relevant commercial product, as indicated by the applicant’s ability to­­ secure independent third-party investor funds.

The NHLBI and NCATS intend to publish a NOFO that will utilize the R44 activity code. The reissue of this NOFO is expected to occur in Fall 2024 with an expected application due date of February 25, 2025. This Notice is being provided to allow potential applicants sufficient time to develop responsive proposals and consider the requirements that are integral to this initiative.

Since its inception in 1982, the NIH SBIR program has provided the small business community with seed funding to support the development of a broad array of commercial products to detect, diagnose, treat, and prevent disease. It provides an important funding mechanism for bringing new interventions to patients and clinicians. The SBIR program is structured in three phases. The objective in Phase I is to establish the technical merit and feasibility of a proposed research and development (R&D) effort, while in Phase II it is to continue the R&D effort for successful Phase I projects. The expectation is that in Phase III, an SBC will be able to launch a product commercially with non-SBIR funds. However, many projects initiated with SBIR funding require considerable financing beyond the SBIR Phase II award to complete the validation studies required to obtain regulatory approval and launch a product. In particular, the development of therapeutics, medical devices, and combination products often requires a number of years and substantial capital investments due to costs associated with conducting clinical trials and/or other steps mandated by the Federal regulatory approval process. Thus, despite the extensive R&D performed on such products during Phase II projects, the results are often insufficient to attract the substantial private investment needed for the eventual commercialization of the product. Many small businesses, therefore, become cash-starved before reaching the next critical milestone along the path toward commercialization. Hence, the planned NOFO is designed to address this funding gap between the end of the SBIR or STTR Phase II award and the point at which non-SBIR financing can be secured for the subsequent stages of product development.

Specific objectives for Phase IIB Small Market RFA are expected to be as follows:

Independent Third-Party Investor Funds: The Phase IIB Small Market RFA will specifically encourage business relationships between applicant SBCs and third-party investors/strategic partners who can provide financing to help accelerate the commercialization of promising new products whose development was initiated with SBIR or STTR funding. Applicants will be expected to leverage their previous SBIR or STTR support, as well as the opportunity to compete for additional NHLBI funding under the expected NOFO, to attract and negotiate third-party financing needed to advance their product or technology toward commercialization. The applicant’s ability to secure independent third-party investor funds will help to validate the commercial potential that is essential for the SBIR projects being announced under the NOFO. Applicants through the Phase IIB Small Market RFA will be expected to secure independent third-party funds that equal or exceed one-third of the requested NHLBI funds (direct costs + indirect costs + fee) being requested for the entire project period of the award.

Scientific/Technical Scope: The technical and commercial objectives described in applications to the Small Market Phase IIB RFA MUST represent an extension of the development efforts that were pursued in a previously funded SBIR or STTR Phase II award. It is essential that significant progress was accomplished during the current/preceding SBIR or STTR Phase II project and that the proposed product has significant commercial potential. Applicants will be expected to demonstrate that the proposed product has a clear advantage over existing and/or competing products and to define an appropriate path toward ultimate product commercialization. The anticipated NOFO will be designed to provide additional support for products that require ultimate approval/clearance by the FDA. Projects previously funded by another NIH Institute/Center or another Federal agency are eligible for funding under the anticipated, as long as proposed projects are relevant to the NHLBI mission. Applicants are strongly encouraged to contact the NHLBI to discuss whether their proposed project meets this criterion. The NHLBI supports development of technologies to detect, prevent, or treat cardiovascular, lung, blood, and sleep disorders. It also supports research on the clinical use of blood and all aspects of the management and safety of blood resources. For more information on scientific areas that fall within the NHLBI mission space, please visit https://www.nhlbi.nih.gov/science. The Phase IIB Small Market RFA will be designed to support the development of products that advance the NHLBI mission and meet the following criteria:

• Address a rare disease or young pediatric populations (aged 0-12 years and defined in Section IV, part 7). The primary indication of the product under development would:
  • Address a rare disease as defined in the Orphan Drug Act Amendment of 1984 as any disease or condition that affects less than 200,000 persons in the United States; or
  • Qualify as a Humanitarian Use Device, defined as a medical device intended to benefit patients in the treatment or diagnosis of a disease or condition that affects or is manifested in fewer than 4,000 persons in the United States per year; or
  • Be targeted at a young pediatric population, defined as including neonates (0-28 days), infants (<2 years), and/or children (2-12 years of age), as indicated in the FDA Premarket Assessment of Pediatric Medical Devices.

Additionally, The National Center for Advancing Translational Science (NCATS) intends to co-fund Phase IIB Small Market applications that meet the NCATS mission to develop innovations that reduce, remove or bypass costly and time-consuming bottlenecks in the translational science process; to speed the development and delivery of new drugs; diagnostics, medical devices and behavioral interventions to patients. NCATS is also interested in co-funding applications that address rare diseases, and in particular, that can help speed the development of treatments for multiple rare diseases. As detailed in NOT-TR-18-025, NCATS is limited to direct support of clinical trials through phase IIB with the exception of phase III (21 CFR definition) clinical trials for treatment of a rare disease or condition.For a description of the NCATS SBIR/STTR research priorities, please refer to http://ncats.nih.gov/smallbusiness/priorities.

Funding Information

Applications are not being solicited at this time. 

Inquiries

Please direct all inquiries to:

Stephanie Davis, Ph.D.
Innovation and Commercialization Office (I&C)
Division of Extramural Research Activities (DERA)
National Heart Lung and Blood Institute (NHLBI)
Telephone: 301-496-8412
Email: [email protected]

Meena Rajagopal, Ph.D.
Office of Strategic Alliances (OSA)
National Center for Advancing Translational Sciences (NCATS)
Telephone: 301-827-1921
Email: [email protected]