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| 62 | Information for Investors and Venture Capital Funds | NCATS' SBIR and STTR programs support translational research and technologies developed by small businesses. The Center welcomes collaborations with investors, venture capital funds and other strategic partners interested in contributing to these efforts to advance translational research. Partners may want to: Encourage companies in their pipelines to apply for SBIR or STTR funding. Engage with an NCATS SBIR or STTR awardee to further develop a technology toward commercialization. Benefits of working with NCATS SBIR and STTR awardees include: Awardees have received non-dilutive capital, not loans. All SBIR and STTR projects undergo rigorous NIH peer review. Multiple venture-backed companies that meet eligibility criteria can apply for SBIR and STTR funding. Companies have access to NIH SBIR small business resources to help in the advancement and commercialization of their products. NCATS invites individual investors, venture capital funds and others to collaborate with the Center in supporting the development of technologies, therapies, approaches and interventions designed to advance patient care. Opportunities to partner with NCATS and support small business research and development occur throughout the year. Learn more about the Center and its SBIR and STTR research priorities. Access a list of NCATS' currently funded small business projects on NIH RePORTER. Explore opportunities to mentor current awardees. Join events at which NCATS will be presenting information about translational sciences and small business funding opportunities. Contact the NCATS SBIR & STTR team to learn more and discuss your interests. | ||||||||
| 61 | Small Business Program Eligibility | Eligibility for the SBIR and STTR programs depends on the phase for which the small business is applying. The funding limits available for small business applicants within each phase vary. Phase I demonstrates the technical merit, feasibility and potential for commercialization efforts. Small businesses in Phase II are continuing the research and development efforts initiated during Phase I. Small businesses can apply for a Direct Phase II SBIR award even if they have not received a Phase I award. Small businesses applying for Fast Track consideration submit one application for Phase I and Phase II that receives combined reviews. Primary eligibility criteria for NCATS' SBIR and STTR programs are listed below. Visit the NIH SBIR & STTR website for a more comprehensive list of eligibility criteria. SBIR Only U.S. small business concerns (SBCs) are eligible to participate in the NIH SBIR program. The small business must meet all of the criteria described in the funding opportunity announcement at the time of Phase I and II awards, including: SBC is an organized for-profit with a place of business located and operating primarily in 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. SBC is in the legal form of an individual proprietorship, partnership, limited liability company, corporation, joint venture, association, trust or cooperative. When the SBC is a joint venture, foreign business entities must have less than 50 percent participation in the joint venture, as further explained: SBC is more than 50 percent directly owned and controlled by one or more individuals who are citizens of or permanent resident aliens in the United States, other business concerns (each of which is more than 50 percent directly owned and controlled by individuals who are citizens of or permanent resident aliens in the United States), or any combination of these. OR SBC is more than 50 percent 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 percent of the SBC. OR SBC is a joint venture in which each entity to the joint venture meets the requirements above. Definitions: 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 in 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 ยง 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. STTR The STTR program is similar in structure to SBIR but funds cooperative research and development projects involving an SBC and a research institution (i.e., nonprofit college or university, federally funded research and development center, or domestic nonprofit research organization). The SBC must meet all the criteria specified in the funding opportunity announcement at the time of Phase I and II awards, including: SBC is an organized for-profit, with a place of business located in the United States and with no more than 500 employees. No size limit pertains to the research institution, but it also must be located in the United States. SBC is more than 50 percent U.S.-owned and independently operated. In addition, the SBC must be engaged in a formal cooperative research and development effort with the research institution. The effort must be managed by the SBC, with at least 40 percent SBC effort and at least 30 percent effort by the research institution. The research institution must be a U.S. nonprofit college or university, domestic nonprofit research organization, or federally funded research and development center. The principal investigator may be principally employed at either the small business or the research institution. | ||||||||
| 60 | Open Small Business Funding Opportunities | Grants Contracts NIH HEAL Initiative Funding Opportunities Notices Relevant to Small Businesses Need Help? Grants Industrialization and Translation of Extracellular Vesicles for use in Regenerative Medicine (UT1/UT2) Clinical Trial Not Allowed STTR: PAR-23-268 Posted: April 18, 2023 Next Deadline: June 06, 2023 Industrialization and Translation of Extracellular Vesicles for use in Regenerative Medicine (U43/U44 Clinical Trials Not Allowed) SBIR: PAR-23-267 Posted: April 18, 2023 Next Deadline: June 06, 2023 Innovations for Healthy Living - Improving Minority Health and Eliminating Health Disparities (R43/R44 - Clinical Trial Optional) SBIR: RFA-MD-23-003 Posted: Jan. 30, 2023 Next Deadline: Sept. 6, 2023 Technologies for Improving Minority Health and Eliminating Health Disparities (R41/R42- Clinical Trial Optional) STTR: RFA-MD-23-002 Posted: Jan. 30, 2023 Next Deadline: Sept. 6, 2023 Botulinum Toxin Potency Assay using Tissue Chips (BoT PATCh) SBIR: RFA-TR-22-032 (U43/U44 - Clinical Trail Not Allowed) Posted: Sept. 19, 2022 Next Deadline: Aug. 21, 2023 STTR: RFA-TR-22-031 (UT1, UT2 Clinical Trail Not Allowed) Posted: Sept. 19, 2022 Next Deadline: Aug. 21, 2023 PHS Omnibus Solicitation of the NIH PHS 2022-2 Omnibus Solicitation of the NIH, CDC and FDA (Clinical Trial Not Allowed) SBIR: PA-22-176 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 STTR: PA-22-178 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 Post: June 2, 2022 Next Deadline: Sept. 5, 2023 Funding Information for PHS 2021-22 Omnibus Solicitation: Research Topics Approved Waiver Topics NCATS will not accept SBIR/STTR applications that include clinical trials under the current Omnibus Solicitation. Learn more. Basket Clinical Trials of Drugs Targeting Shared Molecular Etiologies in Multiple Rare Diseases (U44 Clinical Trial Required) SBIR: RFA-TR-22-029 Post: July 13, 2021 Next Deadline: July 12, 2023 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) SBIR: RFA-HL-23-008 Post: Nov. 16, 2021 Next Deadline: Feb. 28, 2024 See About Small Business Opportunities for more information on the Phase IIB. Innovation Corps (I-Corps) at NIH Program for NIH and CDC Translational Research (Admin Supp Clinical Trial NOT Allowed) PAR-22-073 Post: Nov. 19, 2021 Next Deadline: Nov. 15, 2023 Commercialization Readiness Pilot (CRP) Program Technical Assistance SBIR/STTR: PAR-20-128 (SB1, R44 - Clinical Trial Not Allowed) Posted: July 14, 2020 Next Deadline: Sept. 5, 2023 See: Additional Resources: 2020 SBIR/STTR Omnibus Solicitation Resources Administrative Supplements to Promote Diversity in Research and Development Small Businesses-SBIR/STTR PA-21-345: Administrative Supplements to Promote Diversity in Small Businesses-SBIR/STTR (Admin Supp Clinical Trial Not Allowed) Posted: Sept. 10, 2021 Applications are accepted on a rolling basis at any time starting 30 days after the open date until the expiration date. Expires: Sept. 10, 2024 Contracts No Small Business contracts are available at this time. Notices Relevant to Small Businesses Notice of Special Interest (NOSI): Administrative Supplement for Providing Technical and Business Assistance (TABA) Funding to SBIR/STTR Awardees (Admin Supp) NOT-OD-21-062 Technical and Business Assistance (TABA) Needs Assessment Program for NIH SBIR/STTR Awardees (not applicable to grantees who applied for NOT-OD-21-062) SBIR/STTR: NOT-OD-21-023 NIH Offers Assistance to Active Phase I HHS SBIR and STTR Awardees through the Niche Assessment Program 2018-2019 NOT-OD-19-012 Need Help? The NCATS SBIR & STTR team is available to answer questions related to your potential project idea and provide tips for applying. If you have questions about a specific solicitation, connect with the program contact listed in the solicitation. The Small Business Resources page offers tools and tips to help you develop a successful proposal and access other resources. | View NCATS open opportunities for small business grants and contracts. | /sites/default/files/sbir-2017_1260x630.jpg | Open Small Business Opportunities | View NCATS open opportunities for small business grants and contracts. | /sites/default/files/sbir-2017_1260x630.jpg | Open Small Business Opportunities | ||
| 59 | Small Business Funding | The NCATS SBIR and STTR programs provide technical assistance and funding opportunities to help small business and research organizations advance technologies and research concepts that can eventually be commercialized to improve health. There are two primary SBIR and STTR funding mechanisms: grants and contracts. NCATS also supports other programs that work with small businesses to advance technology products. View all open small business funding opportunities from NCATS. SBIR & STTR Grants Omnibus Solicitation Applications due: January 5, April 5 and September 5 The annual SBIR/STTR Omnibus Solicitation encourages investigator-initiated grant applications across a broad range of research areas. Eligible U.S. small businesses should have the capabilities and technological expertise to contribute to the research and development missions of the awarding NIH Institute or Center. Small businesses interested in NCATS funding should review the Center’s research priorities prior to applying. The typical award date is six to nine months after submission of a successful application. Targeted Grant Funding Announcements Applications due: Varies Throughout the year, NCATS may release funding opportunities or participate in other NIH grant funding announcements to advance technologies in a targeted area. Current announcements are listed on the Open Small Business Opportunities page. Administrative Supplements Active SBIR and STTR grantees are eligible for administrative supplement awards, which have varying application periods and deadlines. I-Corps™ at NIH Innovation Corps (I-Corps™) at NIH is an innovative program to develop and nurture a national innovation ecosystem that builds upon biomedical research to develop technologies, products and services that benefit society. Active SBIR and STTR Phase 1 grantees are eligible to participate. For more information, visit I‑Corps™ at NIH. SBIR & STTR Contracts Applications due: Typically in the fall NCATS accepts applications for SBIR contract funding once each year. Contract topics cover a wide range of technology development areas to help successfully finance and advance innovations toward commercialization. Applicants should review the contract topic areas above and submit a proposal related to one of those topics. Applicants are encouraged to contact the NCATS SBIR & STTR team for more information about the Center’s contract topics of interest. Additional Support for Small Businesses NCATS SBIR and STTR awardees may be eligible for support beyond funding, including access to technical assistance programs and other NCATS small business resources. For More Information Contact the NCATS SBIR & STTR team to discuss your idea or to learn more about NCATS support for small businesses. | ||||||||
| 58 | SBIR & STTR Research Priorities | NIH provides grant opportunities for small businesses in any biomedical or behavioral research area that falls within the agency’s mission to improve human health. NCATS small business funding is designed specifically to transform the translational science process so that new treatments and cures for disease can be delivered to patients more efficiently. NCATS seeks to increase small business participation in federally supported research and development as well as private-sector commercialization of technology developed with federal support. The Center also supports the development of clinical technology, instruments, devices and related methodologies that may have broad application to clinical research and better patient care. NCATS will not accept SBIR/STTR applications that include clinical trials under the current Omnibus Solicitation. Learn more. Explore each area of current interest for NCATS: Preclinical Drug Discovery and Development Biomedical, Clinical & Health Research Informatics Clinical, Dissemination & Implementation Research Clinical Trials Download the NCATS SBIR &STTR research priorities (PDF - 324KB) Preclinical Drug Discovery and Development Innovative platforms for identification and prioritization of targets for therapeutic intervention with clear clinical impact, such as those that are: implicated for disease, have genetic variations that have been identified in functional regions of receptor targets and/or have high potential for biased signaling that would promote the beneficial effects of receptor signaling and reduce the unwanted effects Tools and technologies to enable high-throughput screening of compound activity on currently “non-druggable” targets Assays for high-throughput screening of rare diseases-related targets Co-crystallization high-throughput screening techniques Fluorescence probes to replace antibodies for determination of cellular protein translocation Phenotypic assay development, including stem cell technology platforms for human “disease-in-a-dish” applications and the evaluation of toxicity Interventions that target molecular pathways or mechanisms common to multiple diseases Platforms for non-antibody biologics, cell-based therapies and gene therapy discovery Small molecule and biologics analytical characterization Accelerated bioengineering approaches to the development and clinical application of biomedical materials, devices, therapeutics and/or diagnostics Development of novel technologies for enzyme replacement therapies (e.g., new cell culture/expression system) to solve a major bottleneck in rare diseases research Innovative methods to determine alternative uses for existing therapeutic interventions for high priority areas, such as rare diseases and pain Tools and technologies that increase the predictivity or efficiency of medicinal chemistry, biologic or other intervention optimization Technologies to deliver nucleic acid therapeutics to tissues other than the liver Methodologies and technologies to increase efficiencies of manufacturing therapeutics Development of novel high-throughput technologies that focus on making translational research more efficient GMP production of exosome/extracellular vesicles Generation of producer lines for large-scale production of exosomes/extracellular vesicles Extracellular RNA-based biomarkers and therapeutics of human diseases Approaches to targeting the human microbiome for therapeutic or diagnostic purposes Scale up, manufacturing and characterization of IPS cells 3D printing technologies Technologies to substantially improve the efficiency and reduce the cost of clinical-grade gene therapy vector manufacturing Development of in vitro human tissue models (organs, 3D printing) Technologies to allow therapeutic proteins other than lysosomal enzymes to be secreted and taken up by other cells via cross-correction Novel strategies to prevent deleterious immune responses to gene therapy, genome editing and/or enzyme replacement therapy Establishing more robust phenotypic screens that may help prioritize candidate compounds for further testing Innovative technology for non-small molecule delivery High-throughput epigenetics screening/characterization tools and technologies Microphysiological systems (MPS)/Tissue Chips, including MPS/Tissue Chips that incorporate known functional variants, e.g., ACMG 59 or CPIC A alleles, for study comparison using the same derived genetic background across a set of tissue chips with the functional variant Biomedical, Clinical & Health Research Informatics Searchable access to information about research resources, facilities, methods, cells, genetic tests, molecules, biologic reagents, animals, assays and/or technologies with evidence about their use in research studies Cloud-based tools and methods for meaningful sharing, re-use and integration of research data Novel platforms, technologies and tools for: (1) enabling clinical and translational research, particularly those with mechanisms for inclusion of patient-reported data and (2) integration of patient data collected from multiple devices and multiple/diverse clinical studies Development of personalized phenotypic profiling (as well as personalized intervention) based on patient-centered integration of data from multiple data sources, including social media Development of predictive models for translational science Digital applications and tools (including telemedicine platforms) that facilitate/enhance translational research and medicine in rural populations Generic disease registry template platforms that can be reused for multiple diseases Mobile device validation tools to ensure data from different brands or versions have compatible results Tools to assess algorithms developed with artificial intelligence and/or machine learning Tools that allow for persistent identifier and attribution for data contributors that give credit to the data producers while ensuring that shared data has not been altered Patient mobile tool platforms that facilitate tool developers to build “apps” that integrate into their medical records Tools and environments that enable an easy interrogation of publicly available data Clinical, Dissemination and Implementation Research Tools and technologies that increase the efficiency of human subjects research, that facilitate the rapid diagnosis and/or clinical trial recruitment and subject tracking, institutional review board evaluation and/or regulatory processes Increased efficiency of clinical research conduct, including but not limited to regulatory decision support, patient eligibility analysis and recruitment and retention tracking Tools, technologies and other strategies to evaluate and improve the process of informed consent Educational tools for clinical and translational science Computational or web-based health research methods, including: Platforms for generally applicable and scalable multi-disease registries and natural history studies Clinical trial designs and analyses (e.g., for pragmatic clinical trials) Approaches, tools, platforms and environments to integrate data in novel ways for development of new biomarkers that can be tested in translational research paradigms for which there are barriers or bottlenecks Strategies to enhance the quality of and accelerate the conduct of dissemination and implementation research Sustainable solutions for effective tools and environments in translational research Development and validation of patient reported outcomes, clinician-reported outcomes and biomarkers for rare diseases that are not already supported by a disease-specific NIH Institute or Center Tools, technologies and other strategies that address medication adherence in clinical settings Tools, technologies and other strategies that address and improve community engagement Tools and technologies that address the rapid diagnosis and/or clinical management of rare diseases Patient empowerment tools/apps that allow users to compare their treatment and outcomes to normative populations existing treatment guidelines Telemedicine or digital health applications that focus on research in rural populations Tools and technologies that help characterize human disease states and assist in assessing the impact of interventions Clinical Trials NCATS will not accept SBIR/STTR applications that include clinical trials under the current Omnibus Solicitation. NIH defines clinical trial as a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes. See the Revised NIH Definition of “Clinical Trial” and Clinical Research Policy. Other human subjects research may be submitted through the Omnibus Solicitation and NCATS may decline funding of any application that includes human subjects for programmatic or administrative reasons. SBIR applicants considering projects involving human subjects research are strongly encouraged to contact NCATS-SBIRSTTR@mail.nih.gov. In the future, please note that NIH will release funding opportunity announcements (FOAs) with clinical trial specific requirements. | ||||||||
| 57 | Small Business Frequently Asked Questions | What are the five systems for which applicants need to register before submitting their applications? What kinds of small business projects does NCATS support? How does NCATS support small businesses? My business may be a good candidate for NCATS support — what should I do next? What advice would you have for first-time applicants? How do we know which part of NIH to apply to if our technology touches multiple disease areas? Would my application be forwarded on to another NIH component if there is a better fit? How long does it take to get funding after submitting your application? What are the advantages of coding your application as a woman-owned small business or a socially and economically disadvantaged small business? Does this affect your chance of success? Can you provide guidance on transitioning from a Phase I award to applying for a Phase II grant? Is it possible to submit a Phase II proposal to NCATS if the Phase I was received from a different institute or agency? If an application is rejected, could you provide guidance on the pros/cons of doing a "resubmission" vs a "new proposal"? Does NCATS fund medical device development? Does NCATS fund clinical research or only preclinical research? Where can I get answers if I have more questions? What are the five systems for which applicants need to register before submitting their applications? Unique Entity Identifier (UEI). All registrations require a UEI before beginning the remaining registrations. This number can be obtained through the SAM.gov system. NOTE: UEI replaces the former Dun and Bradstreet Universal Numbering System (DUNS). Current awardees who are already registered in SAM.gov will have a UEI automatically generated. It will be visitable in both SAM.gov and Grants.gov. All entities currently registered in eRA Commons will see their UEI automatically populated int their Institutional Profile File (IPF) and on Page One of the Notice of Award. No entity action is required. See additional information on transitioning from DUNS to the UEI. System for Award Management (SAM.gov). This government website consolidates all business registrations in a government vendor database so that payments can be made more efficiently. Grants.gov. This portal lists all available federal grants and is used by all 26 federal grant-making agencies, including NIH. Electronic Research Administration (eRA Commons). This NIH system allows applicants, grantees and NIH staff to access, share and transmit their applications and grant information. Visit eRA Commons FAQs and tutorials for help registering with the system. SBA Company Registry. Applicants must attach proof of their SBA Company Registry to their SBIR/STTR applications. What kinds of small business projects does NCATS support? The Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs are one of the largest sources of early-stage capital for technology commercialization in the United States. These programs allow US-owned and operated small businesses to engage in federal research and development that has a strong potential for commercialization. The SBIR program includes the following objectives: using small businesses to stimulate technological innovation; strengthening the role of small business in meeting federal R/R&D needs; increasing private sector commercialization of innovations developed through federal SBIR R&D; increasing small business participation in federal R/R&D; and fostering and encouraging participation by socially and economically disadvantaged small business concerns and women-owned business concerns in the SBIR program. NCATS works to increase small business participation in federally supported research and development as well as in private-sector commercialization of technology through its SBIR and STTR programs. Through these efforts, NCATS supports the development of clinical technology, instruments, devices and related methodologies that may have broad application to translational research and better patient care. Review NCATS' SBIR & STTR research priorities and eligibility criteria. How does NCATS support small businesses? NCATS offers small business funding opportunities and access to resources to support commercialization strategies through two different mechanisms: grants and contracts. Grants include the annual SBIR/STTR Omnibus Solicitations for investigator-initiated applications, as well as targeted announcements designed to advance technologies in specific areas. Contracts are made available annually on specific topics covering a range of technology development. Find open small business funding opportunities. NCATS has several programs that are also open to small businesses. They include the TRND program, which provides support for preclinical development of rare or neglected diseases, and the BrIDGs program, which assists researchers in advancing promising therapeutic agents through late-state preclinical development in preparation for an Investigational New Drug application. My business may be a good candidate for NCATS support — what should I do next? NCATS supports research and development for a range of technologies, instruments, devices and related methodologies. To find out if your small business is the right fit for NCATS support: Ensure that your business or research institution meets the eligibility criteria. Review open funding opportunities for small businesses. Explore NCATS' small business research priorities. Contact NCATS to discuss your project and ask questions by emailing NCATS-SBIRSTTR@mail.nih.gov. What advice would you have for first-time applicants? Talk to an NCATS Program Officer. This is an important first step. Program Officers are subject-matter experts and will offer invaluable information about your application, including the relevance to NCATS’s mission and any technical submission questions you may have. Demonstrate the need and commercialization potential. Common reasons that applications don’t score well are: The proposed project is not significant. The application does not address a critical barrier to progress in the field or fails to make a scientifically convincing case for commercial potential or societal impact. The application has not provided an adequately defined test of feasibility. The proposed technology or therapeutic is not sufficiently innovative compared with available products on the market. Applicants should review published work and show how the project is different and better. The application’s research plan is diffuse, superficial or unfocused. Reviewers look for clear specific aims. The application did not fully demonstrate the expertise of the team, strategy or capacity for success. You can find several examples of successful small business grant applications on a variety of topics on the NIH website. Start early. It can take between one and two months to complete all of the application requirements and registrations. You will need to register in five systems before you can submit your application. You can use NIH ASSIST, a program that will walk you through the entire application. Check out our fact sheet on what you need to do to apply. How do we know which part of NIH to apply to if our technology touches multiple disease areas? Would my application be forwarded on to another NIH component if there is a better fit? We encourage applicants to review NCATS' SBIR & STTR research priorities to talk to us before submitting and application to ensure that it is a good fit. If it’s not within our research interests, we’ll recommend another part of NIH. Sometimes applications do span across various institutes. You can also list another NIH institute or center as a secondary assignment on your application. You can also review the NIH Program Descriptions and Topics document. How long does it take to get funding after submitting your application? It generally takes about seven to nine months between application submission and announcement of the award if you are successful. What are the advantages of coding your application as a woman-owned small business or a socially and economically disadvantaged small business? Does this affect your chance of success? Although this information has no bearing on the success of your application, collecting this information allows us to know which segments of the population are applying and to design programs, resources and seminars to better serve these constituencies. Learn more about special designations. View a webinar on opportunities for women entrepreneurs and the SBIR and STTR Can you provide guidance on transitioning from a Phase I award to applying for a Phase II grant? The grantee may submit a Phase II application either before or after expiration of the Phase I budget period. To maintain eligibility to seek Phase II support, a Phase I grantee should submit a Phase II application within the first six receipt dates following the expiration of the Phase I budget period. If the grantee is outside of the receipt period timeframe, they must contact their Phase I Program Officer to determine if the Program Officer is willing to receive a late application. If so, a waiver may be granted. Is it possible to submit a Phase II proposal to NCATS if the Phase I was received from a different institute or agency? It is certainly possible to switch institutes or agencies when moving from Phase I to Phase II if the project direction warrants it. However, we recommend talking to program officers at NCATS and the other institute or agency before applying to ensure the next phase will still be a good fit. Contact NCATS to discuss your project and ask questions. If an application is rejected, could you provide guidance on the pros/cons of doing a "resubmission" vs a "new proposal"? For all phases, when submitting or re-submitting between an RFA and an investigator-initiated funding opportunity (PA, including the SBIR/STTR Omnibus solicitations, PAR, PAS) please review the guidance found in https://grants.nih.gov/grants/guide/notice-files/NOT-OD-18-197.html. Does NCATS fund medical device development? NCATS does not generally focus on medical devices. However, we still encourage you to contact the NCATS staff to determine if what you are proposing is an appropriate fit for the Center’s SBIR/STTR priorities. Does NCATS fund clinical research or only preclinical research? NCATS will not accept SBIR/STTR applications that include clinical trials under the current Omnibus Solicitation. NIH defines a clinical trial as a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes. See the Revised NIH Definition of “Clinical Trial” and Clinical Research Policy. SBIR applicants considering projects involving human subjects research are strongly encouraged to contact NCATS-SBIRSTTR@mail.nih.gov before submission. Where can I get answers if I have more questions? If you have more questions about NCATS' SBIR and STTR programs, contact the Center's small business team for assistance. For general questions about SBIR and STTR at NIH, visit the Frequently Asked Questions (link is external) page on the NIH SBIR & STTR website. For more in-depth discussions of these topics, visit our archive of recent webinars. If you have problems with your electronic submission, contact the Helpdesks for grants.gov and/or the eRA Commons: Web: http://www.grants.gov/web/grants/support.html Web: http://grants.nih.gov/grants/ElectronicReceipt/support.htm#desk | ||||||||
| 56 | Other Small Business Programs | In addition to the SBIR and STTR programs, NIH and NCATS offer technical assistance to small businesses through several other programs. NIH Programs for SBIR and STTR Awardees Phase 1 I-Corps™ at NIH: This program is designed to develop and nurture a national innovation ecosystem that builds on biomedical research to help Phase 1 SBIR and STTR awardees create technologies, products and services that benefit society. Niche Assessment Program (NAP): This NIH program offers Phase 1 SBIR and STTR awardees access to market research and data to help refine a commercialization strategy. Phase 2 Commercialization Accelerator Program (CAP): This NIH program helps Phase 2 SBIR and STTR awardees accomplish key commercialization milestones through mentoring, training and access to industry experts. Commercialization Readiness Pilot (CRP) Program: This NIH program helps Phase 2 SBIR and STTR awardees move their projects to the commercialization stage by providing additional support for technical assistance. Collaborative NCATS Programs Therapeutics for Rare and Neglected Diseases (TRND): This program provides selected researchers with in-kind preclinical support services to move promising small molecules and biologics for rare and neglected diseases into clinical testing. Bridging Interventional Development Gaps (BrIDGs): This program makes available critical resources needed for the development of new therapeutic agents for both common and rare diseases through access to in-kind preclinical services. Tools for Researchers: NCATS-supported programs and projects have produced numerous tools to help researchers advance translational science. Find additional resources for small businesses interested in federal research and development. | ||||||||
| 55 | SBIR & STTR Program Differences | The SBIR and STTR programs have the same goal: to help entrepreneurial researchers launch small businesses, engage in research and development, and commercialize new products that will benefit the public. The programs have two key differences, described below. Project Leadership SBIR requires the project’s principal investigator to be employed primarily (more than half-time) by the small business during the award period, unless NIH grants a waiver of this requirement. STTR does not define employment criteria for the project’s principal investigator. Nonprofit Research Institution Partners STTR requires the small business to have a formal collaboration agreement with a nonprofit research institution during Phases I and II. The research institution is responsible for at least 30 percent of the total effort for the project, and the small business is responsible for at least 40 percent. SBIR encourages but does not require nonprofit research institution partnership. A research institution can complete up to 33 percent of the total effort for a Phase I project and up to 50 percent of the total effort for a Phase II project, as applicable. Criteria SBIR STTR Principal Investigator Primary employment (more than half-time) must be with small business Primary employment may be with small business or research partner; must commit to at least 10 percent effort in project Research Institution Partner Permits partnering, but small business must do at least: Phase I: 67 percent Phase II: 50 percent Requires partnering with U.S. research institution: Small business: at least 40 percent Research partner: at least 30 percent More details about these differences are available on the NIH SBIR & STTR website. | ||||||||
| 54 | SBIR & STTR Program Benefits | The SBIR and STTR programs are one of the largest sources of funding for early-stage companies in the United States. There are many benefits to securing SBIR or STTR funding, including: Funding is stable, predictable and not a loan. Capital is non-dilutive. Small businesses retain intellectual property rights. NIH’s rigorous peer-review provides recognition, validation and visibility to early-stage companies. Prestige associated with the award can help attract more funding or support (e.g., venture capital, strategic partner). In addition to these benefits, recent changes to the SBIR and STTR programs have expanded eligibility. A few key changes are summarized below; visit the NIH SBIR & STTR website for more comprehensive information. Size Regulations NIH may spend up to 25 percent of SBIR funds on small businesses majority owned by multiple venture capital companies, hedge funds or private equity firms. Cross-Program or -Agency Awards STTR Phase I awardees can receive SBIR Phase II awards and vice versa. In addition, Phase I awardees may receive a Phase II award from a different agency. Expanded Technical Assistance NIH has increased flexibility to fund technical assistance for SBIR and STTR awardees ($5,000 per award) through programs like the NIH Commercialization Accelerator Program (Phase II) as well as by request. Commercialization NIH can provide up to 10 percent of SBIR or STTR funds to support commercialization and Phase III efforts. Applicants must provide information on commercialization of prior SBIR or STTR awards. Direct to Phase II NIH can issue a Phase II SBIR award to a small business that did not receive a Phase I award for the relevant research and/or development. Small businesses can submit a "Direct-to-Phase II" SBIR application if the company has performed the type of research conducted in Phase I using other funding sources. | ||||||||
| 53 | About Small Business Opportunities | The Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs are government set-aside programs for U.S. small businesses and research organizations to engage in research and development that has the potential for commercialization and public benefit. The programs are one of the largest sources of American early-stage technology financing. The SBIR and STTR programs support NCATS’ mission to transform the translational science process so that new treatments and cures for disease can be delivered to patients more efficiently. These programs serve as an engine of innovation, offering grants, contracts and technical assistance to small businesses and research organizations focused on advancing translational research and technologies that will improve disease prevention, detection and treatment. In addition to SBIR and STTR, other NCATS programs collaborate with small businesses to develop new translational research technologies. Learn more about these programs. SBIR & STTR Program Structure The NCATS SBIR and STTR programs are structured in three phases. Review the eligibility criteria for these programs. Phase I The objective of Phase I is to establish the technical merit and feasibility of the proposed research and development efforts and to determine the quality of performance of the small business prior to providing further federal support in Phase II. Phase I support is normally $150,000 provided over a period of six months for both SBIR and STTR programs. However, with proper justification, applicants may propose longer periods of time and greater funding amounts necessary to establish the technical merit and feasibility of the proposed project. SBIR: Support may not exceed $350,000 in total costs for six months. STTR: Support may not exceed $350,000 in total costs for one year. Phase II The objective of Phase II is to continue the research and development efforts initiated in Phase I. Generally, only Phase I awardees are eligible for a Phase II award. Phase II awards are normally $1 million over two years for SBIR and STTR. However, with proper justification, applicants may propose longer periods of time and greater funding amounts necessary for completion of the project. Funding is based on Phase I results and may not exceed $2,150,000 in total costs for a two-year period. In addition, a commercialization plan is required. Occasionally, NCATS may accept Phase IIB SBIR Competing Renewal grant applications of NCATS supported Phase II awards to continue research and development of products that have a potential to address bottlenecks in the translational process, and where additional time and effort is needed to reach a stage where interest and investment by third parties would be likely. Such products are expected to have broad applicability and be consistent with the mission of NCATS. Applicants are strongly encouraged to speak to NCATS Program staff prior to submitting their Phase IIB application. Budgets for Phase IIB grant applications must be approved by NCATS Program staff prior to submission. Phase III The objective of Phase III, where appropriate, is for the small business to pursue with non-SBIR/STTR funds the commercialization objectives resulting from the Phase I/II research and development activities. |
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