This Notice of Funding Opportunity (NOFO), the National Cancer Institute (NCI), National Human Genome Research Institute (NHGRI), National Institute of Biomedical Imaging and Bioengineering (NIBIB), and National Institute on Drug Abuse (NIDA) intend to support early-career academic scientists interested in transitioning to entrepreneurship while also supporting the transfer of technology from academic laboratories into small businesses.
Donor Name: National Institutes of Health (NIH)
State: All States
County: All Counties
Type of Grant: Grant
Deadline: 07/21/2023
Size of the Grant: $3M
Grant Duration: 2 years
Details:
This NOFO proposes a new and unique Fast-Track only award structure comprised of a Phase I STTR that transitions to a Phase II SBIR. Only small businesses can apply for and receive SBIR or STTR awards. However, this RFA utilizes an STTR in phase I because the STTR program is intended for projects in which the awardee small business is working closely with a university and therefore allows more work to be completed at the university as well as allowing more flexibility in terms of PI employment. Awards made under this NOFO will begin as a Phase I STTR to allow the early career scientist PI, or candidate, complete proof of concept studies at the academic site and prepare the technology to move into the small business. Upon successful completion of the STTR phase I activities, awards that transition to Phase II will convert to an SBIR award, requiring the PI to move their place of employment to the small business and limiting university involvement.
Both small businesses and universities are drivers of technological innovation in the United States (U.S.), often working together to advance innovative ideas into products that can benefit the U.S. population.While most NIH funding supports basic research in university laboratories, the NIH also supports innovative technology development in U.S. small businesses through its SBIR and STTR programs. As technologies transition from academic discovery to small businesses, two common challenges arise, identifying the right team with the right expertise to take the product into a small business, and funding for early-stage technology development. This NOFO seeks to address both challenges simultaneously by having two equally important goals: entrepreneurial mentoring support, and product development support.
To be responsive to this NOFO, proposed projects MUST pertain to the mission space of one of the participating Institutes and propose the development of a technology that fits into the technology categories described below under additional Institute/Center Priorities. Furthermore, all proposals must include clear, quantitative milestones (i.e. a quantitative definition of success) for each aim. In some cases, additional milestones or timelines may be requested as part of the Just In Time process or post-award. For awards made under this NOFO, transition from phase I to phase II will only occur after demonstration that all of the following criteria have been met; the candidate continues to receive mentoring support by both technical and business development (BD) mentors, all necessary IP agreement(s) are updated to reflect the next award phase timeline, a demonstration that all phase I technical milestones have been achieved.
Institute/Center Priorities
- National Cancer Institute (NCI)
- NCI encourages proposals that fall into several technology areas, including; Cancer Therapeutics and Preventative Agents; Cancer Imaging Technologies, Interventional Devices, and In Vivo Diagnostics; In Vitro and Ex Vivo Cancer Diagnostics and Prognostics; or Technologies for Cancer Prevention and Control, Supportive Care, and Survivorship.
- National Institute of Biomedical Imaging and Bioengineering (NIBIB)
- NIBIB funding of clinical trials will be in accordance with NOT-EB-21-005 “NIBIB Guidance for Support of Clinical Trial Applications.” Briefly, NIBIB will only support mission-focused (see NIBIB’s program areas) early-stage clinical trial applications, i.e., feasibility, Phase I, first-in-human, safety, or other small clinical trials, that inform early stage technology development. NIBIB will not support applications proposing pivotal, Phase II, III, IV, or trials in which the primary outcome is efficacy, effectiveness, or a post-market concern. Also, mechanistic trials are not supported unless the primary focus of the project is on technology development.
- National Institute on Drug Abuse (NIDA)
- NIDA encourages proposals that fall into the following categories: Pharmacotherapeutic approaches for prevention and/or treatment; Therapeutic and Diagnostic Devices, including Imaging Technologies, or In Vitro and Ex Vivo Diagnostics.
- National Human Genome Research Institute (NHGRI)
- NHGRI encourages proposals that fall into the following research areas: Genomic Technology and Methods Development; Bioinformatics, Computational Genomics, and Data Science; Population Genomics and Genomic Medicine; Ethical, Legal, and Social Implications of Genomics; and Genomics Training and Education.
Research Objectives
This NOFO has two simultaneous objectives; (to support the transition of early-career scientists from academia to entrepreneurship, and to support the advancement of technologies out of academic research laboratories into small U.S. businesses.
Funding Information
- Total funding support (direct costs, indirect costs, fee) normally may not exceed $295,924 for Phase I awards and $1,972,928 for Phase II awards.
The following NIH components intend to commit the following amounts in FY 2023:
- NCI, $3M, five to seven awards;
- NIBIB, $1M, one to two awards;
- NIDA, up to $1M, up to three awards.
- NHGRI, up to $700,000, approximately two awards
Project Period
- NCI will allow applicants to request up to 2 years for phase I and 2 years for phase II.
- NIBIB will allow applicants to request up to 1 year for phase I and 2 years for phase II.
- NIDA will allow applicants to request up to 1 year for phase I and 3 years for phase II.
Eligible Applicants
Only United States small business concerns (SBCs) are eligible to submit applications for this opportunity. A small business concern is one that, at the time of award of Phase I and Phase II, meets all of the following criteria:
- Is organized for profit, with a place of business located in the United States, which operates primarily within the United States or which makes a significant contribution to the United States economy through payment of taxes or use of American products, materials or labor;
- Is in the legal form of an individual proprietorship, partnership, limited liability company, corporation, joint venture, association, trust or cooperative, except that where the form is a joint venture, there must be less than 50 percent participation by foreign business entities in the joint venture;
- SBIR and STTR. Be a concern which is more than 50% directly owned and controlled by one or more individuals (who are citizens or permanent resident aliens of the United States), other business concerns (each of which is more than 50% directly owned and controlled by individuals who are citizens or permanent resident aliens of the United States), an Indian tribe, ANC or NHO (or a wholly owned business entity of such tribe, ANC or NHO), or any combination of these; OR
- SBIR-only. Be a concern which is more than 50% owned by multiple venture capital operating companies, hedge funds, private equity firms, or any combination of these. No single venture capital operating company, hedge fund, or private equity firm may own more than 50% of the concern, unless that single venture capital operating company, hedge fund, or private equity firm qualifies as a small business concern that is more than 50% directly owned and controlled by individuals who are citizens or permanent resident aliens of the United States; OR
- SBIR and STTR. Be a joint venture in which each entity to the joint venture must meet the requirements set forth in paragraph 3 (i) or 3 (ii) of this section. A joint venture that includes one or more concerns that meet the requirements of paragraph (ii) of this section must comply with § 121.705(b) concerning registration and proposal requirements.
- Has, including its affiliates, not more than 500 employees.
Small business concerns that are more than 50% owned by multiple venture capital operating companies, hedge funds, private equity firms, or any combination of these are NOT eligible to apply to the NIH STTR program.
Performance Benchmark Requirements
Phase I to Phase II Transition Rate Benchmark: In accordance with guidance from the SBA, the HHS SBIR/STTR Program is implementing the Phase I to Phase II Transition Rate benchmark required by the SBIR/STTR Reauthorization Act of 2011 and the SBIR and STTR Extension Act of 2022. The benchmark establishes a minimum number of Phase II awards the company must have received relative to a given number of Phase I awards received during the 5-fiscal year time period. The Transition Rate is calculated as the total number of SBIR and STTR Phase II awards a company received during the past 5 fiscal years divided by the total number of SBIR and STTR Phase I awards it received during the past 5 fiscal years excluding the most recently-completed year. The Transition Rate requirement, agreed upon and established by all 11 SBIR agencies, was published for public comment in a Federal Register Notice on October 16, 2012 (77 FR 63410) and amended on May 23, 2013 (78 FR 30951).
- For SBIR and STTR Phase I applicants that have received more than 20 Phase I awards over the past 5 fiscal years (excluding the most recently-completed fiscal year): Companies that do not meet or exceed the benchmark minimum Transition Rate of 0.25 will not be eligible to apply for a Phase I, Fast-Track, or Direct Phase II (if available) award for a period of one year from the date of the application submission. This requirement does not apply to companies that have received 20 or fewer Phase I awards over the prior 5-fiscal year period.
- For application deadlines that fall on or after April 5, 2023: For SBIR and STTR Phase I applicants that have received more than 50 Phase I awards over the past 5 fiscal years (excluding the most recently-completed fiscal year): Companies that do not meet or exceed the benchmark minimum Transition Rate of 0.5 will not be eligible to receive more than 20 total Phase I and Phase II awards for a period of one year from the date on which such determination is made. This requirement does not apply to companies that have received 50 or fewer Phase I awards over the 5-fiscal year period.
On June 1 of each year, SBA will identify the companies that fail to meet minimum performance requirements. SBA calculates individual company Phase I to Phase II Transition Rates using SBIR and STTR award information across all federal agencies. SBA will notify companies and the relevant officials at the participating agencies. More information on the Phase I to Phase II Transition Rate requirement is available at SBIR.gov.
Phase II to Commercialization Benchmark: In accordance with guidance from the SBA, the HHS SBIR/STTR Programs are implementing the Phase II to Commercialization Rate benchmark for Phase I applicants, as required by the SBIR/STTR Reauthorization Act of 2011 and the SBIR and STTR Extension Act of 2022. The Commercialization Rate Benchmark was published in a Federal Register notice on August 8, 2013 (78 FR 48537), with a reopening of the comment period published on September 26, 2013 (78 FR 59410).
- For companies that have received more than 15 Phase II awards from all agencies over the past 10 fiscal years (excluding the two most recently completed fiscal year): Companies that meet this criterion must show an average of at least $100,000 in revenues and/or investments per Phase II award or at least 0.15 (15%) patents per Phase II award resulting from these awards during the past 10- fiscal year period. Applicants that fail this benchmark will not be eligible to apply for New Phase I, Fast-track or Direct Phase II (if applicable) awards for a period of one year. This requirement does not apply to companies that have received 15 or fewer Phase II awards over the 10-fiscal year period, excluding the two most recently-completed fiscal years.
- For application deadlines that fall on or after April 5, 2023: For companies that have received more than 50 Phase II awards from all agencies over the past 10-fiscal years (excluding the two most recently completed Fiscal Year): Companies that meet this criterion must show an average of at least $250,000 of aggregated sales and investment per Phase II award over the past 10-fiscal year period. Applicants that fail this benchmark will not be eligible to receive more than 20 total Phase I and Phase II awards for a period of one year from the date on which such determination is made. This requirement does not apply to companies that have received 50 or fewer Phase II awards over the 10-fiscal year period, excluding the two most recently-completed fiscal years.
- For application deadlines that fall on or after April 5, 2023: For companies that have received more than 100 Phase II awards from all agencies over the past 10-fiscal years (excluding the two most recently completed Fiscal Year): Companies that meet this criterion must show an average of at least $450,000 of aggregated sales and investment per Phase II award over the past 10-fiscal year period. Applicants that fail this benchmark will not be eligible to receive more than 20 total Phase I and Phase II awards for a period of one year from the date on which such determination is made. This requirement does not apply to companies that have received 100 or fewer Phase II awards over the 10-fiscal year period, excluding the two most recently-completed fiscal years.
On June 1 of each year, SBA will identify the companies that fail to meet minimum performance requirements. SBA will notify companies and the relevant officials at the participating agencies. More information on the Phase II to Commercialization requirement is available at SBIR.gov.
Foreign Institutions
- Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
- Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
- Foreign components, as defined in the NIH Grants Policy Statement, may be allowed.
For more information, visit Grants.gov.