Description:
The Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs, also known as America's Seed Fund, are one of the largest sources of early-stage capital for technology commercialization in the United States. These programs enable US-owned and operated small businesses to conduct research and development that has a strong potential for commercialization. The National Institutes of Health (NIH) supports small businesses through the SBIR and STTR programs to develop promising technologies and products that align with its mission to improve health and save lives.
Successful small businesses require a breadth of expertise to bring a new technology to market. New companies striving to convert scientific discoveries into healthcare solutions require talented researchers who can also perform duties related to business and product development. While scientists, engineers, and health professionals offer valuable technical skillsets and practical insights required for technology development, academic training and professional experience often do not equip researchers with the skills and knowledge required to successfully navigate the entrepreneurial process, develop and commercialize products, or operate a small business. As a result, mission-driven scientists who are eager to apply their advanced skills through innovative research and development in an entrepreneurial setting may be insufficiently prepared for such roles and face high barriers to transitioning into an entrepreneurial career.
Scientists and trainees from diverse backgrounds and life experiences bring different perspectives, creativity, and individual enterprise to address complex scientific problems. There are many benefits that flow from a diverse NIH-supported scientific workforce, including fostering scientific innovation, enhancing global competitiveness, contributing to robust learning environments, improving the quality of research, advancing the likelihood that underserved or health disparity populations participate in, and benefit from health research, and enhancing public trust. NIH has a commitment to supporting a sustainable and diverse biomedical research workforce (see, e.g., Notice of NIH's Interest in Diversity, NOT-OD-20-031). Fostering and encouraging participation by socially and economically disadvantaged and women-owned small businesses in technological innovation is one of the goals of the SBIR and STTR programs (https://www.sbir.gov/sites/default/files/SBA%20SBIR_STTR_POLICY_DIRECTIVE_May2023.pdf).
Investigators interested in transitioning into an entrepreneurial career path benefit from tailored entrepreneurial training, mentoring, and career development, as well as opportunities to lead innovative research and development programs with strong potential for commercialization. Supplementing the traditional academic experience with training in entrepreneurship and innovation can help provide scientists with both the scientific acumen and business skillset that play a key role in translating innovative ideas into commercial products. By facilitating such training experience, start-ups and other small businesses can recruit and integrate needed domain expertise while at the same time augmenting the entrepreneurial workforce and empowering scientists.
Purpose
The awarding components identified in this NOFO intend to support early-career scientists and health professionals interested in transitioning to a small business to gain industry experience, receive entrepreneurial training and mentorship, and advance biomedical technology with commercial potential as a PD/PI. This NOFO is not intended to support projects led by PDs/PIs with substantial entrepreneurial, business, scientific, or other professional experience. PDs/PIs with significant experience are encouraged to work with their organizations to submit applications to other SBIR and STTR Notices of Funding Opportunity.
This Notice of Funding Opportunity (NOFO) utilizes the R41/R42 STTR Award mechanism to provide small business concerns (SBCs) support for research and development efforts, as well as the opportunity to increase their scientific staff by supporting the employment and salaries of researchers as Program Directors/Principal Investigators (PDs/PIs) overseeing the supported research project. It is expected that each SBC will ensure robust entrepreneurial training and mentorship for the PD/PI, while the PD/PI will bring valuable technical knowledge and/or practical medical expertise to the SBC. This award provides an opportunity for researchers to accelerate growth of their entrepreneurial skills by serving as PDs/PIs while pursuing entrepreneurial training activities. Training activities may include NIH entrepreneurial training programs, locally and/or widely available entrepreneurship- or business-focused courses or workshops, or other options that best serve the PD/PI and SBC needs. Additionally, the SBC is expected to assemble a strong mentoring team that supports the career growth and development of the PD/PI.
SBIR and STTR are phased programs. The main objective in SBIR and STTR Phase I is to establish the technical merit and feasibility of the proposed research and development efforts. An SBIR and STTR Phase II continues the R&D efforts to advance the technology toward ultimate commercialization. An NIH STTR Fast-Track incorporates a submission and review process in which both Phase I and Phase II applications are submitted and reviewed together as one application to reduce or eliminate the funding gap between phases. At the conclusion of an SBIR/STTR Phase II, it is expected that the small business will fully commercialize their product or technology using non-SBIR/STTR funds (either federal or non-federal). Further information about the SBIR and STTR programs can be found at https://seed.nih.gov. Frequently asked questions are available to assist applicants and can answer many basic questions about the program.
This NOFO invites eligible United States small business concerns (SBCs) to submit STTR Phase I and Fast-Track grant applications. Small business applicants interested in submitting an SBIR grant application should submit to PAR-24-131. Applications submitted to this NOFO are not allowed to propose clinical trial(s). STTR applications that propose clinical trial(s) should be submitted to PAR-24-134. Direct to Phase II applications are not allowed under this funding opportunity and should be submitted to another STTR Notice of Funding Opportunity.
Key Components
A. Mentorship
One primary criterion of this NOFO is mentorship. Applications must identify at least one mentor who will facilitate the successful completion of the project, from both the technical and commercial points of view. In doing so, the mentor will also equip the PD/PI with key technical and business acumen. The mentor should have extensive entrepreneurial and prior mentorship experience. The mentor can be a co-founder, owner, or C-level executive in the SBC, though neither holding one of these positions nor being affiliated with the applicant SBC is required. Mentors may not serve as a multiple PD/PI (MPI). Other mentors or mentoring teams that can provide additional focal points of guidance may be included by the applicant.
B. Entrepreneurship Training
Another key component of the program is entrepreneurship training. A career development plan for the PD/PI is required, and may include a combination of coursework, workshops, or other programs. Mentors should play a key role in identifying appropriate training opportunities to bolster the technical and business acumen of the PD/PI, as well as the commercial prospects of the proposed research and capacity of the small business.
C. Eligibility
This NOFO supports the transition of early-career researchers into entrepreneurial roles, and eligibility of the contact PD/PI is limited to scientists, engineers, and health professionals, including certain late-stage students, postdoctoral fellows or associates, and clinicians, who are new to research entrepreneurship and have not independently led significant research programs. (See Section III for eligibility information.) The transitioning researcher should possess research skills and experience in scientific discovery or technology development. All eligible scientists are encouraged to apply; optimal PDs/PIs for this award may be Early Stage Investigators or New Investigators. NIH always encourages individuals from diverse backgrounds, including individuals from underrepresented groups in the biomedical, clinical, behavioral, and social sciences, such as individuals from underrepresented racial and ethnic groups, individuals with disabilities, individuals from other disadvantaged backgrounds, and women to work with their organizations to apply for NIH support. (See Notice of NIH's Interest in Diversity, NOT-OD-20-031; see also Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019.) With an interest in expanding the range of institutions training researchers entering the biomedical entrepreneurial workforce, NIH also strongly encourages applications with eligible PDs/PIs who are graduates or affiliates of institutions in Institutional Development Award (IDeA) states or Resource-Limited Institutions. (See Notice of Special Interest: Encouraging Small Businesses to Partner with Resource-Limited Institutions (RLIs) on Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) Program Applications, NOT-OD-23-179.)
The PD/PI may be a new employee hired for the purpose of leading the program described in the application or may be an existing employee newly elevated to a position of genuine leadership, responsibility, and authority for the purpose of directing the activities proposed in the application. Additional investigators can serve as MPI and provide support to the transition of the scientist to a PD/PI role within the small business. However, applicants utilizing a multi-PD/PI option should ensure the transitioning scientist is listed as the contact PD/PI on the application and has a clearly defined role that allows sufficient autonomy to exercise genuine leadership and independence that enables personal and professional growth.
D. Scientific/Technical Scope
To be responsive to this PAR, proposed projects must pertain to the mission space of one of the participating Institutes and Centers (ICs) and the proposed technology must fall within the scope of the traditional SBIR/STTR grant mechanisms. Applicants are encouraged to contact the Scientific/Research Contacts from pertinent NIH ICs listed in Section VII prior to submission to discuss IC program relevance. Furthermore, all proposals must include clear, quantitative milestones (i.e., a quantitative definition of success) for each aim for both research and development and entrepreneurial development. In some cases, additional milestones or timelines may be requested as part of the Just-in-Time process or post-award.
Institute/Center Priorities
National Center for Advancing Translational Sciences (NCATS)
NCATS is transforming translational science to improve human health; it relies on the power of data, new technologies and teamwork to develop, demonstrate and disseminate innovations that reduce, remove or bypass costly and time-consuming bottlenecks in translational research. NCATS small business funding is designed specifically to transform the translational science process so that new treatments and cures for diseases can be delivered to patients more quickly. The Center supports the development of technologies, assays, drugs, devices, instruments, and methodologies that may have broad application to any stage of the translational process from preclinical development to clinical research and to implementation science in patient care and public health. For additional information, please visit http://www.ncats.nih.gov and https://ncats.nih.gov/funding/small-business-programs.
Potential applicants are strongly encouraged to email NCATS program staff at NCATS-SBIRSTTR@mail.nih.gov before applying. For this funding opportunity, only the Phase I applications will be supported by NCATS. NCATS Phase I budget waiver amount is $350K, if applying under one of the NCATS waiver topics ( see PHS 2023-2 SBIR/STTR Program Descriptions and Research Topics for NIH, CDC, and FDA).
National Center for Complementary and Integrative Health (NCCIH)
The NCCIH supports the development and validation of technologies that can facilitate the integration of complementary and integrative health approaches to enhance diagnosis, prevention, or treatment of diseases and/or associated symptoms, or promotion of well-being and whole person health. In addition, the NCCIH supports the integration of the technologies with multisystem studies to understand the connections and interactions across the systems and/or the impact of multi-component interventions on multisystem connections and interactions in pre-clinical models and/or human subjects. NCCIH will not fund clinical efficacy or effectiveness of an intervention at Phase I.
Complementary health approaches include a broad range of practices and interventions that are not typically part of conventional medical care and can be classified by their primary therapeutic input, including nutritional (e.g., special diets, dietary supplements, herbs, probiotics, and microbial-based therapies), psychological (e.g., meditation, hypnosis, music-based interventions, relaxation therapies), physical (e.g., acupuncture, massage, chiropractic manipulation, other force-based manipulations, or devices related to these approaches), or a combination of psychological and physical (e.g., yoga, tai chi, dance therapies, or some forms of art therapies, such as music-based interventions) input.
For detailed description see: https://www.nccih.nih.gov/grants/nccih-sbir-and-sttr-research-priorities.
National Eye Institute (NEI)
The National Eye Institute (NEI) leads the federal government in conducting and supporting research in vision research. The mission of the NEI is to eliminate vision loss and improve quality of life through vision research. The NEI has framed its current strategic plan around this mission which addresses multiple opportunities as challenges in the vision field.
NEI will support milestone-driven, commercialization-oriented applications that address ophthalmology and vision sciences through this NOFO. The overarching goal is to reduce visual impairment and blindness and thus resulting in an improvement in the quality of life for people of all ages. In all these areas and related areas of ophthalmology and vision sciences research, NEI encourages an emphasis on understanding and addressing health disparities that are experienced by underserved populations.
For this funding opportunity, only the Phase I applications will be supported by NEI.
Applicants are encouraged to submit applications that align to the NEI Strategic Plan: NEI Strategic Plan: Vision for the Future (PDF 22.5 MB).
To determine if your research fits within the NEI mission, please contact the appropriate Program Director in the NEI Small Business Research Program (https://www.nei.nih.gov/grants-and-training/funding-opportunities/programs-and-research-priorities/small-business).
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. NHGRI encourages Small Business research and development applications with commercial potential that are comprehensive across the genome or are generalizable across variants, tissues, diseases or functions. NHGRI recognizes the importance of diversity in the genomic workforce, without which the promise of genomics cannot be fully achieved. 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.
For detailed descriptions see: https://www.genome.gov/research-funding/Funding-Opportunities-Overview/contacts-by-research-area
National Heart, Lung, and Blood Institute (NHLBI)
The National Heart, Lung, and Blood Institute (NHLBI) provides global leadership for research, training, and education programs to promote the prevention and treatment of heart, lung, blood, and sleep (HLBS) diseases and conditions. For a full list of the NHLBI’s research priorities, please visit https://www.nhlbi.nih.gov/about/strategic-vision/research-priorities.
Product Development Goals and Entrepreneurial Training for PI. Under this NOFO, the NHLBI is interested in supporting applications that develop innovative technologies with strong commercial potential that are relevant to the scientific priorities of the NHLBI. Simultaneously, investigators are expected to request appropriate training, mentoring, and career development opportunities that facilitate their successful transition to an entrepreneurial career path. The NHLBI will support Phase I and Fast-Track applications from both early-career scientists and investigators with data science, artificial intelligence/machine learning, engineering, clinical care and other biomedical backgrounds who are new to the NIH SBIR/STTR programs. Fast-Track applications should include specific and measurable product development milestones and go/no-go criteria for the Phase I/Phase II transition, a career development plan that logically integrates with and spans both Fast-Track award stages, and a sound commercialization plan.
Change of the primary PI’s mentor. If there is a change in Key Personnel identified as a primary mentor to the PI, Prior Approval will be required regardless of the mentor’s percent level of effort.
Potential applicants are strongly encouraged to contact the NHLBI Program Contacts at least 30 days before the application due date.
National Institute on Aging (NIA)
NIA Small Business Programs are looking for groundbreaking solutions to enhance and extend healthy aging with particular interest in solutions addressing Alzheimer’s disease (AD) and AD-related dementias (ADRD) treatment and care. This includes innovations to support healthy aging and aging in place, interventions to help people with aging-related diseases, solutions for aging-related challenges and needs, tools to efficiently assess and diagnose aging-related diseases, and technologies to reduce burden and improve care and services. With this NOFO, NIA is specifically looking to foster the advancement and accelerate the growth of early-career scientists, and other individuals new to entrepreneurship, in the aging biotech landscape.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
The mission of the National Institute on Alcohol Abuse and Alcoholism is to generate and disseminate fundamental knowledge about the adverse effects of alcohol on health and well-being, and apply that knowledge to improve diagnosis, prevention, and treatment of alcohol-related problems, including alcohol use disorder, across the lifespan. Topics of research, related to this NOFO, should align with the NIAAA Program Descriptions. Potential applicants are strongly encouraged to contact the NIAAA SBIR/STTR team prior to submitting an application.
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
NIAMS supports research into the causes, treatment, and prevention of arthritis and musculoskeletal and skin diseases; the training of basic and clinical scientists to carry out this research; and the dissemination of information on research progress in these diseases (https://www.niams.nih.gov/about).
Please note: It is not the intent of NIAMS to support clinical trials through the SBIR/STTR mechanism. Applicants who wish to submit clinical trial applications to the NIAMS are encouraged to utilize one of the NIAMS funding opportunities listed at https://www.niams.nih.gov/grants-funding/conducting-clinical-research/investigator-clinical-trial-policies.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
The mission of the NICHD is to lead research and training to understand human development, improve reproductive health, enhance the lives of children and adolescents, and optimize abilities for all.
Potential applicants should propose topics that align with NICHD’s research priorities. Please visit https://www.nichd.nih.gov/grants-contracts/research-areas/priorities for information on NICHD’s research themes, objectives, cross-cutting topics, and aspirational goals.
For this NOFO, NICHD will only support Phase I applications. Although it includes Phase I, NICHD will not support Fast-Track applications for this NOFO.
National Institute on Drug Abuse (NIDA)
The National Institute on Drug Abuse (NIDA) is the Federal Government’s lead agency for supporting scientific research on drug abuse and addiction. Through this NOFO, NIDA encourages research that addresses the institute’s mission. NIDA is explicitly interested in scalable products with a clearly defined market need and commercial potential for the substance use disorders (SUD). Specific topics of interest for NIDA include, but are not limited to:
SUD drug discovery and development
FDA-regulated medical therapeutic and diagnostic devices for SUD
Technological approaches to address stigma associated with SUDs
New technological approaches for the investigation, diagnosis, and certification of deaths related to drug overdose
PIs are encouraged to contact NIDA program staff in advance of submitting applications to discuss the fit. NIDA appreciates the value of diversity in seeking the solutions for SUD. NIDA encourages entrepreneurs from diverse backgrounds, including those from underrepresented racial and ethnic groups and women entrepreneurs, to work with their organizations to apply.
National Institute on Deafness and Other Communication Disorders (NIDCD)
The National Institute on Deafness and Other Communication Disorders (NIDCD) supports a wide range of basic, clinical and translational research on communication disorders including those affecting hearing, balance, taste, smell, voice, speech, and language. Applicants are encouraged to submit applications that align to the NIDCD Strategic Plan.
For this funding opportunity, only the Phase I applications will be supported by NIDCD.
National Institute of Dental and Craniofacial Research (NIDCR)
The NIDCR conducts and fosters research on the etiology, pathogenesis, prevention, diagnosis, and treatment of oral, craniofacial and dental diseases and conditions. For more specific information about areas of interest to the NIDCR, please visit the NIDCR webpage and NIDCR Grant Programs. NIDCR’s small business programs are highly focused on maximizing translational science opportunities – moving rapidly and translating basic dental and orofacial preclinical studies into clinically useful products.
NIDCR does not support clinical trials within SBIR/STTR applications. Small business concerns proposing a clinical trial must use the UG3/UH3 program. Projects seeking to propose technology validation studies within SBIR/STTR applications that involve human subjects research must provide a detailed justification describing that the funds available through these awards can adequately support the proposed human study.
National Institute of Environmental Health Sciences (NIEHS)
The mission of the National Institute of Environmental Health Sciences (NIEHS) is to discover how the environment affects people in order to promote healthier lives, with a vision of providing global leadership for innovative research that improves public health by preventing disease and disability www.niehs.nih.gov. NIEHS achieves its mission and vision through a multidisciplinary biomedical research program, prevention and intervention efforts, and a communication strategy that encompasses training, education, technology transfer and community outreach. NIEHS SBIR grants help small businesses develop innovative and commercially viable products or technologies for environmental health sciences. Small Business Innovation Research & Small Business Technology Transfer Grants (SBIR/STTR, R41, R42, R43, R44) (nih.gov)
NIEHS will only support Phase I applications in response to this NOFO. Phase I budgets for general applications are limited to the current SBA guidelines of $306,872 total cost (direct costs, indirect costs, and fees). Applicants applying to the Superfund Research Program Hazardous Substances Remediation and Site Characterization SBIR Program are limited to total funding support (direct costs, indirect costs, and fees) of $173,075 for Phase I applications.
National Institute of Nursing Research (NINR)
The National Institute of Nursing Research (NINR) supports research to solve pressing health challenges and inform practice and policy – optimizing health and advancing health equity into the future. To achieve our mission, NINR has identified five complementary and synergistic research lenses that best leverage the strengths of nursing research and promote multilevel approaches, cross-disciplinary and -sectoral collaboration, and community engagement in research. NINR supports research aligned with our mission and strategic priorities, conducted by scientists from any discipline. For the purposes of this initiative, NINR is interested in technology that will promote health equity, account for social determinants of health, and advance prevention and health promotion in non-hospital settings (e.g., homes, schools, workplaces, clinics, justice settings, and the community).
To determine if your research fits within the NINR mission, please contact an NINR Program Director.
National Library of Medicine (NLM)
The National Library of Medicine (NLM) offers support for research and development projects in biomedical informatics and data science. Biomedical informatics and data science research applies computer and information sciences to improve the access, storage, retrieval, management, dissemination and use of biomedical information. Grants are made to U.S. small businesses that seek to undertake informatics research and development leading to commercialization. Critical research areas include: representation of medical knowledge in computers; organization and retrieval issues for image databases; enhancement of human intellectual capacities through virtual reality, dynamic modeling, artificial intelligence, and machine learning; medical decision-making; linguistic analyses of medical languages and nomenclatures; investigations of topics relevant to health information or library science; biotechnology informatics issues; and informatics for disaster management. For additional information about areas of interest to NLM and a listing of NLM funded applications, please visit http://www.nlm.nih.gov/ep. Business concerns interested in exploring SBIR/STTR grant opportunities with NLM are encouraged to reach out to the NLM Scientific/Research Contact prior to submitting an application.
Pre-Application Technical Assistance Webinar
NIH will hold a technical assistance webinar on June 11th, 2024 from 3:00 PM to 5:00 PM (Eastern Time) for the following NOFOs:
PAR-24-131, Small Business Transition Grant for New Entrepreneurs (R43/R44 Clinical Trial Not Allowed)
PAR-24-132, Small Business Transition Grant for New Entrepreneurs (R43/R44 Clinical Trial Required)
PAR-24-133, Small Business Transition Grant for New Entrepreneurs (R41/R42 Clinical Trial Not Allowed)
PAR-24-134, Small Business Transition Grant for New Entrepreneurs (R41/R42 Clinical Trial Required)
The purpose of this webinar is to discuss the goals and objectives of the awarding components on the NOFO, highlight unique components of the application content and review criteria, and answer questions from attendees. Potential applicants are encouraged to submit their questions to NIH SEED (Small business Education and Entrepreneurial Development) at SEEDinfo@nih.gov in advance of the webinar.
Information on registration for the webinar and webinar materials can be found at the following link: https://seed.nih.gov/aboutseed/events/20240330/small-business-transition-grant-new-entrepreneurs-webinar.
Participation in this webinar, although encouraged, is optional and is not required for the submission of an application in response to PAR-24-131, PAR-24-132, PAR-24-133, or PAR-24-134.
