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NIH Small Business Innovation Research (SBIR) Phase IIB Strategic Breakthrough Award (Parent [R44] Clinical Trial Optional)

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Contract Overview

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The National Institutes of Health (NIH) plans to release a Notice of Funding Opportunity inviting qualified U.S. small business concerns to apply for the Small Business Innovation Research (SBIR) Phase IIB Strategic Breakthrough grants. This program, involving multiple NIH Institutes and Centers, aims to support the continuation of research and development efforts to advance technologies toward commercialization. It specifically targets addressing the funding gap often referred to as the "Valley of Death," which occurs after the conclusion of initial SBIR/STTR Phase II awards but before a technology reaches the market. The Phase IIB Strategic Breakthrough award provides additional funding for projects that require substantial time and effort, including those involving regulatory approvals, complex instrumentation, clinical research tools, or behavioral interventions. Applications are not currently being solicited; this announcement is intended to give potential applicants time to prepare collaborative and responsive proposals. The funding opportunity will utilize the R44 activity code and encourages U.S. small businesses with relevant research capabilities to consider applying. Collaborative efforts that combine different areas of expertise are particularly encouraged. Importantly, applicants must demonstrate at least 100% matching funds to be eligible for this Phase IIB award. The NIH SEED office serves as the point of contact for interested parties seeking additional information.

General Info

NIH invites US small businesses to apply for SBIR Phase IIB grants, requiring 100% matching funds.

Agency

Department Of Health And Human Services → National Institutes Of Health

NAICS

541714 - Research and Development in Biotechnology (except Nanobiotechnology)View NAICS

Place of Performance

Not specified

Set-Aside

NONE

Documents

(0)

No documents available

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Organization & Contact Information

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AgencyDepartment Of Health And Human Services → National Institutes Of Health
Contacts1 person available
OfficeUS
Organization / Agency
Department Of Health And Human Services → National Institutes Of Health
Office AddressUS
Contacts
NIH SEED (Small business Education and Entrepreneurial Development
contact@example.gov
+1 (555) 000-0000

Full Description

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The National Institutes of Health (NIH), including the following NIH Institutes and Centers (ICs): NCI, NEI, NHLBI, NIA, NIAAA, NIAID, NICHD, NIDDK, NIGMS, NIMH, NIMHD, NINDS, NCATS, ORIP, and ORWH, intends to publish a Notice of Funding Opportunity (NOFO) to invite eligible United States small business concerns (SBCs) to submit Small Business Innovation Research (SBIR) Phase IIB Strategic Breakthrough grant applications. The main objective of a SBIR/STTR Phase II award is to continue R&D efforts to advance a technology toward commercialization. If the technology is not available for sale or use by the end of the SBIR/STTR Phase II award, the SBC must use non-SBIR/STTR funds to reach market access. This funding gap, between the end of the SBIR/STTR Phase II award and customer access, which affects most medical biotechnology products, is known as the “Valley of Death.” The NIH Phase IIB Strategic Breakthrough award provides additional support to mitigate this funding gap for projects that require extraordinary time and effort, including those requiring regulatory approval or are developing complex instrumentation, clinical research tools, or behavioral interventions.

Applications are not being solicited at this time. Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects. This NOFO will utilize the R44 activity code. United States small businesses that have the research capabilities and technological expertise to contribute to the R&D mission(s) of the NIH awarding components identified in this NOFO are encouraged to begin to consider applying for this new NOFO. In addition, collaborative investigations combining expertise will be encouraged and these investigators should also begin considering applying for this application. Prospective applicants should keep in mind that they must demonstrate not less than 100 percent matching funds to be considered for a Phase IIB Strategic Breakthrough award.

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