Small Business Transition Grant For Early Career Scientists (R41/R42 Clinical Trial Not Allowed)

Small Business Transition Grant For Early Career Scientists (R41/R42 Clinical Trial Not Allowed) is sponsored by National Cancer Institute (NCI), National Institute of Biomedical Imaging and Bioengineering (NIBIB), National Human Genome Research Institute (NHGRI), and National Institute of Mental Health (NIMH) / NIH. This NOFO supports early-career academic scientists (within 10 years of post-graduate experience) interested in transitioning to entrepreneurship and transferring technology from academic labs into small businesses.

Expired RFA-CA-24-023: Small Business Transition Grant For Early Career Scientists (R41/R42 Clinical Trial Not Allowed) This notice has expired. Check the NIH Guide for active opportunities and notices. Department of Health and Human Services Part 1.

Overview Information Participating Organization(s) National Institutes of Health ( NIH ) Components of Participating Organizations National Cancer Institute ( NCI ) National Human Genome Research Institute ( NHGRI ) National Institute of Biomedical Imaging and Bioengineering ( NIBIB ) National Institute of Mental Health ( NIMH ) Funding Opportunity Title Small Business Transition Grant For Early Career Scientists (R41/R42 Clinical Trial Not Allowed) R41 Small Business Technology Transfer (STTR) Grant - Phase I R42 Small Business Technology Transfer (STTR) Grant - Fast-track November 14, 2023 - Clarification of Implementation of the NIH SBIR and STTR Foreign Disclosure Pre-award and Post-Award Requirements.

See Notice NOT-OD-24-029 . June 12, 2023 - Implementation of the NIH SBIR and STTR Foreign Disclosure Pre-award and Post-Award Requirements­­. See NOT-OD-23-139 .

February 23, 2023 - Notice of Change to Minimum Performance Standards for SBIR and STTR Applicants­­. See NOT-OD-23-092 . August 31, 2022 - Implementation Changes for Genomic Data Sharing Plans Included with Applications Due on or after January 25, 2023.

See Notice NOT-OD-22-198 . August 5, 2022 - Implementation Details for the NIH Data Management and Sharing Policy. See Notice NOT-OD-22-189 .

Funding Opportunity Number (FON) Companion Funding Opportunity See Section III. 3. Additional Information on Eligibility.

Assistance Listing Number 93. 394, 93. 172, 93.

286, 93.

242 Notice of Funding Opportunity Purpose Through 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 of Mental Health (NIMH) 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.

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.

Open Date (Earliest Submission Date) Letter of Intent Due Date(s) Renewal / Resubmission / Revision (as allowed) AIDS - New/Renewal/Resubmission/Revision, as allowed All applications are due by 5:00 PM local time of applicant organization. Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

No late applications will be accepted for this Notice of Funding Opportunity (NOFO). Required Application Instructions It is critical that applicants follow the SBIR/STTR (B) Instructions in the How to Apply – Application Guide , except where instructed to do otherwise (in this NOFO or in a Notice from the NIH Guide for Grants and Contracts ).

Conformance to all requirements (both in the How to Apply – Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the How to Apply – Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the How to Apply – Application Guide , follow the program-specific instructions.

Applications that do not comply with these instructions may be delayed or not accepted for review. Part 1. Overview Information Part 2.

Full Text of Announcement Section I. Notice of Funding Opportunity Description Section II. Award Information Section III.

Eligibility Information Section IV. Application and Submission Information Section V. Application Review Information Section VI.

Award Administration Information Section VII. Agency Contacts Section VIII. Other Information Part 2.

Full Text of Announcement Section I.

Notice of Funding Opportunity Description Through this Notice of Funding Opportunity (NOFO), the National Cancer Institute (NCI), National Institute of Biomedical Imaging and Bioengineering (NIBIB), National Human Genome Research Institute (NHGRI), and National Institute of Mental Health (NIMH) 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.

For the purposes of this funding announcement, eligibility as an early career scientist is limited to applicants with 10 years, or less, of post-graduate experience. This NOFO allows for Phase I only STTR applications, and Fast-Track applications that use a unique 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, applications submitted as a fast-track award will transition to Phase II as an SBIR award, requiring the PI to move their place of employment to the small business and limiting university involvement. Mentoring is a key component of Small Business Transition Grant awards.

Traditionally, mentoring has not been a factor in SBIR/STTR funding decisions, however, because mentoring is critical to facilitate the transition from junior academic scientist to entrepreneur, a mentoring plan is required in the application and included in the peer review scoring criteria for this NOFO.

The ideal candidate for a Small Business Transition Grant award is a postdoctoral researcher who participated in technology discovery during their academic work and is now ready to move to a small business with the support of an experienced team to advise them.

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 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 (more information under Section IV.

Application Submission Information). Academic laboratories are critical partners for U.S. small businesses that are supported by the NIH SBIR/STTR Programs. These academic laboratories fulfill many roles, including both as the technology originators and collaborators of U.S. small businesses.

This NOFO was developed, with the participation of multiple NIH ICs, to support a changing landscape of entrepreneurship where universities are increasingly encouraging junior scientists to become entrepreneurs. IC Specific Areas of Research Interest Specific Areas of Research Interest from the participating NIH ICs of this NOFO are listed below.

Applicants are strongly encouraged to contact the Scientific/Research Contacts from various NIH ICs listed in Section VII prior to submission to discuss IC program relevance. National Cancer Institute (NCI): The National Cancer Institute (NCI) SBIR/STTR programs support the development, translation, and commercialization of novel therapeutics, devices, diagnostics, and processes that are aimed at reducing the burden of cancer.

A retrospective economic impact analysis of NCI SBIR/STTR Phase II grants from 1998-2010 indicated there was a substantial rate of commercialization, with 247 products commercialized from 690 Phase II grants. Sales of products and services associated with these grants were reported at $9. 1 billion.

Based on the reported sales, economic modeling calculated that over 107,000 jobs were created and $26. 2 billion of economic output was produced.

National Institute of Biomedical Imaging and Bioengineering (NIBIB) : The Small Business program at the National Institute of Biomedical Imaging and Bioengineering (NIBIB) is used to achieve the mission of the institute by supporting innovative technologies through various stages of commercial research and development.

The NIBIB welcomes SBIR and STTR applications from small businesses proposing ideas relevant to its scientific program areas . Please contact program staff if you have questions about which institutes(s) would be the best fit for your technology. National Human Genome Research Institute (NHGRI) : The National Human Genome Research Institute (NHGRI) strives to improve the health of all humans through advances in genomics research.

The NHGRI Small Business Program encourages research and development applications with commercial potential that are comprehensive across the genome or are generalizable across variants, tissues, diseases or functions.

National Institute of Mental Health (NIMH) : The mission of the National Institute of Mental Health (NIMH) is to transform the understanding and treatment of mental illnesses through basic and clinical research, paving the way for prevention, recovery, and cure. The goal of the NIMH SBIR and STTR programs is to support small businesses to develop technologies that can advance the mission of the institute.

Institute/Center Priorities National Cancer Institute (NCI) NCI encourages proposals that fall into several technology areas, including; (1) Cancer Therapeutics and Preventative Agents; (2) Cancer Imaging Technologies, Interventional Devices, and In Vivo Diagnostics; (3) In Vitro and Ex Vivo Cancer Diagnostics and Prognostics; or (4) Technologies for Cancer Prevention and Control, Supportive Care, and Survivorship.

National Institute of Biomedical Imaging and Bioengineering (NIBIB) The NIBIB is interested in the above topics for this NOFO as they pertain to NIBIB mission. NIBIB interests include the development and integration of advanced bioengineering, sensing, imaging, and computational technologies for the improvement of human health and medical care.

An application is not within the NIBIB mission if its principal focus is the development of a technology with the goal of understanding basic biological functions or pathological mechanisms. Additionally, NIBIB only supports projects developing platform technologies that are applicable to a broad spectrum of disorders and diseases.

However, applicants may propose research that utilizes only a single tissue, organ, or physiological condition as a model system to facilitate the development of what is expected to be a more broadly applicable enabling technology. Potential applicants are encouraged to send a draft specific aims page to the NIBIB Small Business Program ( [email protected] ) to determine if their research fits within the NIBIB mission.

National Human Genome Research Institute (NHGRI) NHGRI priority areas are described in the NHGRI 2020 Strategic Vision and generally fall into one or more of the following research areas : 1) Genomic Technology Development; 2) Genome Structure and Function; 3) Computational Genomics; 4) Genomic Variation, Population Genomics and Disease; 5) Clinical Genomics and Sequencing; 6) Genomic Medicine Implementation and Evaluation; 7) Ethical, Legal, and Social Implications of Genomics; and 8) Genomics Training and Education.

National Institute of Mental Health (NIMH) NIMH is interested in projects that fall within our program priorities: https://www. nimh. nih.

gov/funding/sbir/nimh-sbir-sttr-program-priorities . Research Objectives and Requirements This NOFO has two simultaneous objectives; (1) to support the transition of early-career scientists from academia to entrepreneurship, and (2) to support the advancement of technologies out of academic research laboratories into small U.S. businesses. Key Requirements for this NOFO A.

Requirement for strong mentors Mentoring is a key component of this NOFO, and review of the mentors and mentoring plan is included in the scored peer review criteria. While candidates must have independent oversight over the project, each proposal must identify at least two mentors, one mentor who will advise the candidate on technology development, and one mentor who will advise the candidate on business development.

More specifically, the purpose of the technical mentor is to help the candidate devise the best technical path forward by providing feedback on the appropriate assays and models to reach each developmental milestone. The purpose of the business development mentor is to help the candidate maintain a milestone-driven R&D plan and advise the candidate on which R&D milestones are appropriate for commercial development.

Each mentor must provide a letter of support that outlines their commitment to the development of the technology and to the candidate. The identified mentors must meet the following criteria: Technical mentor : The technical mentor should be the head of the academic laboratory from where the technology originated or be recognized as a key opinion leader in the same field as the technology being developed.

This person may also be a co-founder, owner, or a C-level executive in the small business. Business Development (BD) Mentor : The BD mentor could be an experienced BD executive, an experienced entrepreneur, an employee of a university’s technology transfer/innovation office, or an entrepreneur-in-residence (EIR).

The BD mentor must have experience in an appropriate biotech sector relevant to the technology under development and should have experience as an executive in an industry setting or experience mentoring startups. Ideally, a BD mentor would have a track record of mentoring emerging entrepreneurs.

Other mentors : Applicants can include, but are not required to include, additional mentors or mentoring teams that will help them identify appropriate milestones and/or development strategy. The application must describe how each mentor will contribute to the success of the candidate and the success of the technology.

The purpose of the Small Business Transition Grant is to support early-career scientists who are transitioning from an academic research setting to a small business. Therefore, eligibility is limited to early-career scientists. For more information on who qualifies as an early career scientist, see eligibility in section III below.

C. Scientific/Technical Scope Applications will be considered if they are within the mission of one of the participating Organizations/Institutes as described above under "Additional Institute/Center Priorities." Additional Institute/Center Requirements National Institute of Mental Health (NIMH) Potential applicants should reach out to NIMH before submitting an application.

Each grant awarded through NIMH will be required to complete either the C3i Program: https://www. nibib. nih.

gov/research-funding/concept-clinic-commercializing-innovation-c3i-program/c3i-validationexecution or the I-Corps program at NIH: https://sbir. cancer. gov/commercialization/business/icorps ..

National Institute of Biomedical Imaging and Bioengineering (NIBIB) Each grant awarded through NIBIB will be required to completed one of the two C3i programs at NIH ( https://www. nibib. nih.

gov/research-program/c3i-program ). The NIH C3i program is designed to provide medical device innovators with the specialized business frameworks and essential tools for successful translation of biomedical technologies from the lab (concept) to the market (clinic).

There are two versions of this program, the educational C3i (eC3i) program is a 10-week virtual program, which the C3i Validation/Execution program is a 24-week in-depth commercialization course. Both programs require 10 hours of work each week divided by the team members.

In some circumstances when the project team has already completed a non-NIH entrepreneur training program prior to award, the project teams may be given an exemption from the NIH C3i program requirement. An exemption request must be submitted in writing to the NIBIB small business office ( [email protected] ). Exemptions will only be considered for awardees and will not be considered prior to application submission.

Exemptions from NIH C3i program are case by case and are not guaranteed even if the project team has previously completed an entrepreneur training program.

Evaluation of Transitioning from Phase I to Phase II The transition from Phase I to Phase II will only occur after the following criteria are met and documentation approved by a transition committee coordinated by the funding IC; (1) a Phase I final progress report that includes a description of the Phase I success criteria and a demonstration that the success criteria were met, as well as a description of key learnings experiences of the Candidate (see description below); (2) an updated commercialization plan that identifies changes from the original commercialization plan including changes based on learnings from I-Corps at NIH or C3i program as well as other entrepreneurial activities and events; (3) an updated IP agreement and an updated letter of support from the university that describes the current status of the IP, e.g. license option extension or executed license, etc., the metrics that the university used to evaluate the IP and verification that the university continues to support the small businesses efforts to develop and commercialize the technology; (4) updated letters of support from the technology mentor and BD mentor that describe the professional growth of the Candidate during the Phase I project period, and a description of the mentoring relationship in Phase II based on the needs of the Candidate; (5) full participation and completion of I-Corps at NIH or C3i program, unless exempted in writing from their program officer; (6) Verification that all SBIR eligibility requirements are met as all awards must transition to SBIR in Phase II (see below for SBIR eligibility criteria).

Because of the dual focus on mentoring and product development, it is expected that the Phase I portion of several applications may propose fairly high-risk activities.

While high-risk activities are allowed in Phase I, transition to Phase II is dependent upon demonstrating adequate technical success in Phase I, projects that fail to meet their success criteria or do not demonstrate adequate technical progress in Phase I as determined by the transition committee, will not transition to Phase II. See Section VIII. Other Information for award authorities and regulations.

Section II. Award Information Grant: A financial assistance mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity. Application Types Allowed New (Phase I, Fast-Track) Resubmission (All Phases) The OER Glossary and the How to Apply – Application Guide provide details on these application types.

Only those application types listed here are allowed for the NOFO. Not Allowed: Only accepting applications that do not propose clinical trials Need help determining whether you are doing a clinical trial? Funds Available and Anticipated Number of Awards The following NIH components intend to commit the following amounts in FY 2024: NCI, $3.

2M, five to eight awards; NIMH up to $1M, up to three awards; NIBIB, $1M, one to two awards; NHGRI, up to $800,000, one to two awards. The number of awards is contingent upon NIH appropriations, reauthorization and extension of the SBIR and STTR programs, and the submission of a sufficient number of meritorious applications.

Total funding support (direct costs, indirect costs, fee) normally may not exceed $306,872 for Phase I awards and $2,045,816 for Phase II awards. For specific topics, NIH may exceed these total award amounts. The current list of approved topics can be found at https://seed.

nih. gov/sites/default/files/NIH_Topics_for_Budget_Waivers. pdf .

Each participating component may also set their own budget limit (higher or lower than the above) in the “Limited Amount of Award Section” of their respective topics section . Applicants are strongly encouraged to contact program officials prior to submitting any application in excess of the total award amounts listed above and early in the application planning process.

In all cases, applicants should propose a budget that is reasonable and appropriate for the completion of the research project. NCI will allow applicants to request up to 2 years for Phase I and 3 years for Phase II. NHGRI will allow applicants to request up to 2 years for Phase I and 2 years for Phase II.

NIMH will allow applicants to request up to 2 years for Phase I and 3 years for Phase II NIBIB will allow applicants to request up to 1 year for Phase I and 2 years for Phase II. NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this NOFO. Section III.

Eligibility Information 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: 1.

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; 2.

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; i. 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 ii.

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 iii. 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.

4. Has, including its affiliates, not more than 500 employees. 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.

If the concern is more than 50% owned by multiple venture capital operating companies, hedge funds, private equity firms, or any combination of these falls under 3 (ii) or 3 (iii) above, see Section IV. Application and Submission Information for additional instructions regarding required application certification.

If an Employee Stock Ownership Plan owns all or part of the concern, each stock trustee and plan member is considered an owner. If a trust owns all or part of the concern, each trustee and trust beneficiary is considered an owner. Hedge fund has the meaning given that term in section 13(h)(2) of the Bank Holding Company Act of 1956 (12 U.S.C.

1851(h)(2)). The hedge fund must have a place of business located in the United States and be created or organized in the United States, or under the law of the United States or of any State. Portfolio company means any company that is owned in whole or part by a venture capital operating company, hedge fund, or private equity firm.

Private equity firm has the meaning given the term “private equity fund” in section 13(h)(2) of the Bank Holding Company Act of 1956 (12 U.S.C. 1851(h)(2)). The private equity firm must have a place of business located in the United States and be created or organized in the United States, or under the law of the United States or of any State.

Venture capital operating company means an entity described in § 121. 103(b)(5)(i), (v), or (vi). The venture capital operating company must have a place of business located in the United States and be created or organized in the United States, or under the law of the United States or of any State.

ANC means Alaska Native Corporation. NHO means Native Hawaiian Organization. SBCs must also meet the other regulatory requirements found in 13 C.

F. R. Part 121.

Business concerns, other than investment companies licensed, or state development companies qualifying under the Small Business Investment Act of 1958, 15 U.S.C. 661, et seq. , are affiliates of one another when either directly or indirectly, (a) one concern controls or has the power to control the other; or (b) a third-party/parties controls or has the power to control both.

Business concerns include, but are not limited to, any individual (sole proprietorship) partnership, corporation, joint venture, association, or cooperative. The How to Apply – Application Guide should be referenced for detailed eligibility information.

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-fiscalyear 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