Part 1. Overview Information

Key Dates

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.

There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

1. Use the NIH ASSIST system to prepare, submit and track your application online.
2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.
   
   
3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.



Table of Contents
Part 1. Overview Information
Key Dates
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

Background

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) and Centers for Disease Control and Prevention (CDC) support small businesses through the SBIR and STTR programs to develop promising technologies and products that align with their 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). CDC similarly encourages applications from organizations that support scientists and trainees with diverse backgrounds, including sexual orientation and gender identify minorities as well as individuals with disabilities.  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 or public health 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 organization to submit applications to other SBIR and STTR Notices of Funding Opportunity.

This Notice of Funding Opportunity (NOFO) utilizes the R43/R44 SBIR 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 or public health 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 SBIR 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 and https://www.cdc.gov/os/technology/innovation/sbir.htm. 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 SBIR Phase I and Fast-Track grant applications. Small business applicants interested in submitting an STTR grant application should submit to PAR-24-133. Applications submitted to this NOFO are not allowed to propose clinical trial(s). SBIR applications that propose clinical trial(s) should be submitted to PAR-24-132. Direct to Phase II applications are not allowed under this funding opportunity and should be submitted to another SBIR 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, clinicians, and public health practitioners, 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.) CDC similarly encourages applications from organizations that are uniquely prepared to address underserved groups, including sexual orientation and gender identity minorities as well as individuals with disabilities. With an interest in expanding the range of institutions training researchers entering the biomedical entrepreneurial workforce, NIH and CDC also strongly encourage 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 and CDC 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 [email protected] 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 Diabetes and Digestive and Kidney Diseases (NIDDK)

The mission of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) is to conduct and support medical research and research training and to disseminate science-based information on diabetes and other endocrine and metabolic diseases; digestive, hepatobiliary, and pancreatic disorders and nutrition and obesity; and kidney, urologic, and hematologic diseases, to improve people’s health and quality of life. For more information about NIDDK small business programs, applicants are encouraged to review the current Program Descriptions and Research Topics document found at the NIH SEED SBIR and STTR Funding Opportunities page: https://seed.nih.gov/small-business-funding/find-funding/sbir-sttr-funding-opportunities.  Potential applicants are strongly encouraged to contact a Program staff in one of NIDDK’s scientific program areas before submitting an application: https://seed.nih.gov/NIDDK/scientific_program_areas.  For this NOFO, NIDDK will only support Phase I applications (not Fast-Track applications).

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.

National Institute for Occupational Safety and Health (NIOSH)

The National Institute for Occupational Safety and Health (NIOSH) is part of the U.S. Centers for Disease Control and Prevention (CDC). It has the mandate to assure “every man and woman in the Nation safe and healthful working conditions and to preserve our human resources.” NIOSH has more than 1,500 employees from a diverse set of fields including epidemiology, medicine, nursing, industrial hygiene, safety, psychology, chemistry, statistics, economics, and many branches of engineering. NIOSH works closely with the Occupational Safety and Health Administration (OSHA) and the Mine Safety and Health Administration in the U.S. Department of Labor to protect American workers.

NIOSH is particularly interested in applications that address personal protective equipment/technologies, exposure assessment, engineering controls, and emergency preparedness and response in occupational environments.

For additional information about NIOSH, please visit their web site at: http://www.cdc.gov/niosh/programs.

Investigator initiated applications that have commercial potential that fall within the research mission of the NIOSH will be considered through this solicitation. Research to address emerging health threats, health disparities, and health equity are strongly encouraged.

CDC does not support/participate SBIR Fast-Track applications.

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 [email protected] 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.

See Section VIII. Other Information for award authorities and regulations.

Section II. Award Information

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

1. Eligible Applicants

Only United States small business concerns (SBCs) are eligible to submit applications for this opportunity. A small business concern is one that, at the time of award of Phase I and Phase II, meets all of the following criteria:
 

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;

3.

1. 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
2. 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
3. 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.

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.

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 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-fiscal year period.

On June 1 of each year, SBA will identify the companies that fail to meet minimum performance requirements. SBA calculates individual company Phase I to Phase II Transition Rates using SBIR and STTR award information across all federal agencies. SBA will notify companies and the relevant officials at the participating agencies. More information on the Phase I to Phase II Transition Rate requirement is available at SBIR.gov.

Phase II to Commercialization Benchmark: In accordance with guidance from the SBA, the HHS SBIR/STTR Programs are implementing the Phase II to Commercialization Rate benchmark for Phase I applicants, as required by the SBIR/STTR Reauthorization Act of 2011 and the SBIR and STTR Extension Act of 2022. The Commercialization Rate Benchmark was published in a Federal Register notice on August 8, 2013 (78 FR 48537), with a reopening of the comment period published on September 26, 2013 (78 FR 59410).

• For companies that have received more than 15 Phase II awards from all agencies over the past 10 fiscal years (excluding the two most recently completed fiscal year): Companies that meet this criterion must show an average of at least $100,000 in revenues and/or investments per Phase II award or at least 0.15 (15%) patents per Phase II award resulting from these awards during the past 10- fiscal year period. Applicants that fail this benchmark will not be eligible to apply for New Phase I, Fast-track or Direct Phase II (if applicable) awards for a period of one year. This requirement does not apply to companies that have received 15 or fewer Phase II awards over the 10-fiscal year period, excluding the two most recently completed fiscal years.

• For application deadlines that fall on or after April 5, 2023: For companies that have received more than 50 Phase II awards from all agencies over the past 10-fiscal years (excluding the two most recently completed Fiscal Year): Companies that meet this criterion must show an average of at least $250,000 of aggregated sales and investment per Phase II award over the past 10-fiscal year period. Applicants that fail this benchmark will not be eligible to receive more than 20 total Phase I and Phase II awards for a period of one year from the date on which such determination is made. This requirement does not apply to companies that have received 50 or fewer Phase II awards over the 10-fiscal year period, excluding the two most recently completed fiscal years.

• For application deadlines that fall on or after April 5, 2023: For companies that have received more than 100 Phase II awards from all agencies over the past 10-fiscal years (excluding the two most recently completed Fiscal Year): Companies that meet this criterion must show an average of at least $450,000 of aggregated sales and investment per Phase II award over the past 10-fiscal year period. Applicants that fail this benchmark will not be eligible to receive more than 20 total Phase I and Phase II awards for a period of one year from the date on which such determination is made. This requirement does not apply to companies that have received 100 or fewer Phase II awards over the 10-fiscal year period, excluding the two most recently completed fiscal years.

Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, may be allowed.

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the How to Apply – Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference NIH Grants Policy Statement 2.3.9.2 Electronically Submitted Applications for additional information.

• System for Award Management (SAM) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • Unique Entity Identifier (UEI) – A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
• SBA Company Registry – See How to Apply – Application Guide for instructions on how to register and how to attach proof of registration to your application package. Applicants must have a UEI to complete this registration. SBA Company registration is NOT required before SAM, Grants.gov or eRA Commons registration.
• eRA Commons – Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.gov registration; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov – Applicants must have an active SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account.  PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, 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. 

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

Under the SBIR program, for both Phase I and Phase II, the primary employment of the PD/PI must be with the small business concern at the time of award and during the conduct of the proposed project. For projects with multiple PDs/PIs, at least one must meet the primary employment requirement. Occasionally, deviations from this requirement may occur.
 

The How to Apply – Application Guide should be referenced for specific details on eligibility requirements. For institutions/organizations proposing multiple PDs/PIs, see Multiple Principal Investigators section of the How to Apply – Application Guide.

Individuals are eligible to serve as the PD/PI if they:

• Have never been an independent PD/PI on an NIH or CDC research grant (R series and equivalent cooperative agreement or contract activities), or corresponding non-NIH peer-reviewed research grant, over $100,000 direct costs per year, or Project Lead on a sub-project of a program project (P01) or center (P50) grant; and
• Are a U.S. Citizen or Lawful Permanent Resident.

2. Cost Sharing

This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement Section 1.2 Definition of Terms.

3. Additional Information on Eligibility

Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

NIH and CDC will not accept similar grant applications with essentially the same research focus from the same applicant organization. This includes derivative or multiple applications that propose to develop a single product, process, or service that, with non-substantive modifications, can be applied to a variety of purposes. Applicants may not simultaneously submit identical/essentially identical applications under both this funding opportunity and any other HHS funding opportunity, including the SBIR and STTR Parent announcements.

The NIH and CDC will not accept duplicate or highly overlapping applications under review at the same time, NIH Grants Policy Statement 2.3.7.4 Submission of Resubmission Application. This means that the NIH and CDC will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review. (see NIH Grants Policy Statement 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

A Phase I recipient may submit a Phase II application either before or after expiration of the Phase I budget period, unless the recipient elects to submit a Phase I and Phase II application concurrently under the Fast-Track procedure. To maintain eligibility to seek Phase II or IIB support, a Phase I recipient should submit a Phase II application, and a Phase II recipient should submit a Phase IIB application, within the first six due dates following the expiration of the Phase I or II budget period, respectively.

An individual may serve as the PD/PI for no more than one application.

Mentor(s)

The mentor is expected to have prior experience in mentoring entrepreneurs. Past or present leadership, mentoring, and outreach activities to promote diversity and inclusion is encouraged—including outreach activities to  groups underrepresented in the biomedical research enterprise (e.g., individuals from underrepresented racial and ethnic groups, persons with disabilities, students from disadvantaged backgrounds, and women as described in the Notice of NIH's Interest in Diversity).

The mentor must be committed to the goals of the transition award, namely the career development of the PD/PI as well as the commercial development of the product. The mentor, who must be listed as key personnel but not an MPI, is required to commit at least 5% time or 0.6 calendar months to these obligations; time commitments across other active awards must not preclude this amount of availability.

To meet the mentoring requirement, PDs/PIs may identify a group of mentors (i.e., a mentoring team) if this is deemed advantageous for providing expert advice in all aspects of the research and career development of the PD/PI. In such cases, one individual must be identified as the primary mentor and fulfill the eligibility criteria above; other members of the mentoring team do not need to fulfill the criteria.

In Phase I, normally, two-thirds or 67% of the research or analytical effort is carried out by the small business concern. The total amount of all consultant and contractual arrangements to third parties for portions of the scientific and technical effort is generally not more than 33% of the total amount requested (direct, F&A/indirect, and fee).

In Phase II, normally, one-half or 50% of the research or analytical effort is carried out by the small business concern. The total amount of consultant and contractual arrangements to third parties for portions of the scientific and technical effort is generally not more than 50% of the total Phase II amount requested (direct, F&A/indirect, and fee).

Deviations from these requirements may be considered on a case by case basis. Please contact a program officer for additional information. Deviations must be approved in writing by the Grants Management Officer (GMO) after consultation with the agency SBIR Program Manager/Coordinator.

A small business concern may subcontract a portion of its SBIR or STTR award to a Federal laboratory within the limits above. A Federal laboratory, as defined in 15 U.S.C. § 3703, means any laboratory, any federally funded research and development center, or any center established under 15 U.S.C. §§ 3705 & 3707 that is owned, leased, or otherwise used by a Federal agency and funded by the Federal Government, whether operated by the Government or by a contractor.

The basis for determining the percentage of work to be performed by each of the cooperative parties in Phase I or Phase II will be the total of the requested costs attributable to each party, unless otherwise described and justified in “Consortium/Contractual Arrangements” of the PHS 398 Research Plan component of SF424 (R&R) application forms.

Additional details are contained in the SF424 (R&R) SBIR/STTR Application Guide.

Section IV. Application and Submission Information

1. Requesting an Application Package

The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this NOFO. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the SBIR/STTR (B) Instructions in the How to Apply – Application Guide, except where instructed in this notice of funding opportunity to do otherwise. Conformance to the requirements in the How to Apply – Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Letter of Intent

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

• Descriptive title of proposed activity
• Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity

The letter of intent should be sent to:
NIH SEED (Small business Education and Entrepreneurial Development)
Telephone: 301-827-8595
Fax: 301-480-0146
Email: [email protected]

All page limitations described in the How to Apply – Application Guide and the Table of Page Limits must be followed.

The following section supplements the instructions found in the How to Apply – Application Guide and should be used for preparing an application to this NOFO.

All instructions in the How to Apply – Application Guide must be followed.

All instructions in the How to Apply – Application Guide must be followed.

All instructions in the How to Apply – Application Guide must be followed with the following additional instructions:

Facilities & Other Resources

In addition to describing the scientific environment and the company support, the applicant must describe the business environment and resources, or how the small business concern will obtain access to the appropriate business resources, for completing and commercializing the proposed product or service. This includes any relevant intellectual property associated with the project necessary to facilitate commercialization.

Project Summary/Abstract:

In addition to summarizing the research project to be conducted under the transition award, also summarize the objectives, rationale, and design of the PD/PI's career development and mentoring plans.

Other Attachments:

1. SBIR Application Certification for small business concerns majority-owned by multiple venture capital operating companies, hedge funds, or private equity firms

Applicant small business concerns that are majority-owned by multiple venture capital operating companies, hedge funds, or private equity firms (e.g. majority VCOC-owned) are required to submit a Certification at time of their application submission per the SBIR Policy Directive.  Follow the instructions below. 

Applicants small business concerns who are 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), or any combination of these (i.e. NOT majority VCOC-owned) should NOT fill out this certification and should NOT attach it to their application package.

1. Download the “VCOC Certification.pdf” at the NIH SBIR Forms webpage. 

2. Answer the 3 questions and check the certification boxes.

3. The authorized business official must sign the certification.

4. Save the certification using the original file name.  The file must be named “SBIR Application VCOC Certification.pdf”.  DO NOT CHANGE OR ALTER THE FILE NAME.  Changing the file name may cause delays in the processing of your application.

5. When you are completing the application package, attach this certification as a separate file by clicking "Add Attachments" located to the right of Other Attachments field on the “Research and Related Other Project Information” form.

2. Career Development Plan

A career development plan for the PD/PI is required for all grant applications. The plan cannot exceed three pages, should include clear milestones and success criteria, and should be organized into the following sections:

Section 1: Background and Project Fit

Describe the PD/PI’s relevant scientific, technical, or professional history, including any role the PD/PI played in the discovery or development upon which the proposed research project builds. Explain how the PD/PI's technical and non-technical background is a good fit for the proposed project and positions the project for successful execution.

Discuss how a lack of experience and/or non-technical skills currently impede the PD/PI’s career growth or limit professional opportunities as an entrepreneur. Applicants may also describe any circumstances that make career development and mentorship opportunities particularly valuable or likely to positively impact the career trajectory of the PD/PI. Such circumstances may include personal or professional adversity, such as difficulty in accessing resources, or graduating from an institution offering few opportunities for business experience or connections to businesses or potential mentors, which may include institutions in IDeA states or Resource-Limited Institutions. Please note that the race, ethnicity, or sex of PDs/PIs will not be considered in the application review process or when making funding decisions.

Section 2: Career Objectives and Plan for Professional Growth

Describe the short-term and long-term career objectives of the PD/PI and the role of entrepreneurial training and a career transition to entrepreneurship in achieving those goals. Present a systematic plan for training and career development of the PD/PI, explaining how the training will contribute to progress of the PD/PI towards the career objectives, furtherance of their entrepreneurial career, and the success of the proposed research project. The career development plan must be specifically tailored to meet the needs and skill or knowledge gaps of the PD/PI and the goal of achieving competence in building biomedical small businesses. Describe specific proposed activities that will lead to new and/or enhanced skills and knowledge, which may relate to, for example, medical product regulation, customer discovery, market assessment, communications, financing, intellectual property, or other topics. Activities should reflect pedagogical best practices and have been demonstrated to be effective; they may include courses, training programs, workshops, as well as one-on-one mentoring.

Applicants should identify specific resources that they intend to utilize to enhance their entrepreneurial skills development. Applicants may, as appropriate, leverage existing entrepreneurial training activities from academic, private-sector, or federal government resources, such as: Economic Development Administration's Build to Scale (B2S); National Science Foundation’s Regional Innovation Engines, Innovation Corps (I-Corps), and National Innovation Network; Small Business Administration's Growth Accelerators and Federal and State Technology (FAST) awardees; National Center for Advancing Translational Sciences' Clinical and Translational Science Awards (CTSA); National Institute of Biomedical Imaging and Bioengineering's Concept to Clinic: Commercializing Innovation (C3i) Program and Point-of-Care Technologies Research Network (POCTRN); National Institute of General Medical Sciences' Regional Technology Transfer Accelerator Hubs for IDeA States, IDeA Regional Entrepreneurship Development Program (I-RED), IDeA Networks of Biomedical Research Excellence (INBRE), IDeA Networks for Clinical and Translational Research (IDeA-CTR), and Centers of Biomedical Research Excellence (COBRE); and NIH's Centers for Accelerated Innovations (NCAI), Research Evaluation and Commercialization Hubs (REACH), and I-Corps at NIH. For example, applicants may propose participation in the structured I-Corps at NIH or C3i program as a central component of their development plan, though they are not required to do so and recipients of the award are not guaranteed admission or access to other NIH resources. Applicants proposing utilization of resources or participation in activities with limited availability are encouraged to identify alternative resources or plans to be implemented if the proposed activities cannot be accessed.

Section 3: Mentor Utilization

Describe how the PD/PI plans to utilize the expertise of the proposed mentor(s) throughout the project to advance both research project and professional development objectives. Explain any formal or informal lines of authority between the PD/PI and proposed mentor, highlighting how the PD/PI will ensure sufficient autonomy to exercise leadership and independence that enables personal and professional growth. If the application identifies a group of mentors (i.e., a mentoring team), describe the relationship between the mentors and how their efforts and contributions will be coordinated. If the plan for professional growth described in Section 2 proposes participation in a program or activity that requires significant mentor involvement, including I-Corps at NIH and C3i, indicate whether the identified mentor(s) will participate; if the mentor(s) will not participate, discuss who will take their place and why they will be a good fit for the program or activity.

3. Mentor Letter of Support

A single letter of support from the mentor(s) highlighting their commitment to the project, as well as to the PD/PI's professional growth, is required. The letter should not exceed two pages, and its content should be tailored to address the needs of the individual PD/PI. The letter should highlight the following:

• Mentor Background and Fit. Describe the mentor's scientific and/or entrepreneurial background, professional history, and relationship with the technology and the SBC (including any formal roles within the SBC). Describe the key areas where the mentor's experience will add value to the PD/PI's professional growth and project advancement; highlight relevance and complementarity to the PD/PI and proposed research project. Additionally, describe any past or present leadership, mentoring, and outreach activities to promote diversity and inclusion—including outreach activities to groups underrepresented in the biomedical research enterprise (e.g., individuals from underrepresented racial and ethnic groups, persons with disabilities, students from disadvantaged backgrounds, and women as described in the Notice of NIH's Interest in Diversity).
• Mentor Goals and Objectives. Describe the goals and objectives of the mentor and how these align with those of the PD/PI.
• Mentoring Plan. Describe the anticipated relationship between the mentor and the PD/PI, including the frequency and type of interactions, and expectations for technical and/or business development progress over the entire period of the proposed project. Also describe how the mentor will monitor the PD/PI’s experience to ensure a work environment that is inclusive and supportive.

If the Career Development Plan identifies a mentor as a participant in any training activities (e.g., I-Corps at NIH or C3i program), the mentor should describe their commitment to participate in the Mentor Letter of Support.

All instructions in the How to Apply – Application Guide must be followed.

At least one proposed mentor is required to be listed as key personnel with a time commitment of at least 5% or 0.6 calendar months. Proposed mentors should have demonstrated experience and capability in providing technical and/or business-related guidance and project leadership. The profiles of proposed mentors should highlight such experience and complement the profile of the PD/PI.

All instructions in the How to Apply – Application Guide must be followed.

Because mentors are advising the PD/PI on R&D-related activities, mentors are allowed to request salary support. Mentors employed by the applicant small business may request salary support as a senior/key person (Section A); mentors not employed by the small business may request salary support as a consultant (Section F).

The budget may include allowable expenses to be incurred during the performance period for entrepreneurial training of the PD/PI. Applicants may request travel to conferences or career development courses as long as these activities are reasonable for the career development of the PD/PI and the advancement of the research project. A brief rationale and description of how the travel will further the development of the PD/PI and technology must be included in the budget justification.

All instructions in the How to Apply – Application Guide must be followed.

All instructions in the How to Apply – Application Guide must be followed.

SBIR/STTR Information Form

All instructions in the How to Apply – Application Guide must be followed.

Resource Sharing Plans:

Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.

Other Plan(s)

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

• All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) applicants are required to address a Data Management and Sharing Plan, regardless of the amount of direct costs requested for any one year. However, SBIR and STTR recipients may retain the rights to data generated during the performance of an SBIR or STTR award for up to 20 years after the award date, per the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) Program Policy Directive. An acceptable Data Management and Sharing plan can reference and incorporate these data rights. Further information about SBIR and STTR data rights are enumerated in the NIH GPS.

Appendix:

Note that Phase I SBIR/STTR Appendix materials are not permitted.  Only limited items are allowed in the Appendix of other small business applications.  The instructions for the Appendix of the Research Plan are described in the How to Apply - Application Guide; any instructions provided here are in addition to the How to Apply - Application Guide Instructions.

All instructions in the SF424 (R&R) SBIR/STTR Application Guide must be followed.

When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the How to Apply - Application Guide, with the following additional instructions:

If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the How to Apply - Application Guide must be followed.

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the How to Apply - Application Guide must be followed.

All instructions in the How to Apply - Application Guide must be followed.

3. Unique Entity Identifier and System for Award Management (SAM)

See Part 2. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), eRA Commons, and Grants.gov

4. Submission Dates and Times

Part I.  contains information about Key Dates and time. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time.  If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the How to Apply – Application Guide.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

Applicants are encouraged to carefully review Subsection 7.9 Allowability of Costs/Activities to determine which proposed items of cost, such as registration fees and travel, may be included in the cost portion of grants. Note that, under this funding opportunity, project objectives are considered to include research, career development, and mentoring objectives identified in the application. Applicants are also encouraged to review 18.3 Allowable and Unallowable Costs and 18.5.4 Allowable Costs and Fee for information specific to for-profit organizations and SBIR and STTR awards, including the request and use of a profit or fee paid to a SBC receiving an award under the SBIR and STTR programs. Applicants are encouraged to contact the Financial/Grants Management Contacts from pertinent NIH and CDC ICs listed in Section VII prior to submission to discuss allowable and unallowable costs and request and use of a profit or fee.

Applications and awards are only transferable to a new PD/PI in extenuating circumstances following application submission or during the project period. Requests to change to a new PD/PI that does not meet all individual eligibility requirements are expected to provide particularly strong and compelling justification for the change and selection of the specific PD/PI.

7. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF424 (R&R) SBIR/STTR Application Guide.  Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply – Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile form. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the How to Apply - Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review, NIH. Applications that are incomplete or non-compliant will not be reviewed.

Applicants are required to follow the instructions for post-submission materials, as described in the policy.

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

For this particular NOFO, note the following: Reviewers will consider holistically if there are adequate avenues for the PD/PI to receive entrepreneurial training and mentorship, and whether these avenues are appropriate for, and likely to benefit, the PD/PI and the proposed research project. In addition, reviewers will assess the commitment to, and ability to balance, both the professional and technology development aspects of the project.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Reviewers will consider each of the review criteria below in the determination of scientific merit and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

2. Review and Selection Process 

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by Center for Scientific Review (CSR), in accordance with NIH peer review policies and practices, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications will receive a written critique.

Applications may undergo a committee process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH or CDC Institute or Center. Applications will compete for available funds with all other recommended applications. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.
• Security risk as assessed by the HHS Due Diligence Program.

Disclosure Requirements Regarding Ties to Foreign Countries

Upon request applicants are required to disclose all funded and unfunded relationships with foreign countries, using the Required Disclosures of Foreign Affiliations or Relationships to Foreign Countries form (referred to as the “Disclosure Form” hereafter), for all owners and covered individuals. A “covered individual” is defined as all senior key personnel identified by the SBC in the application (i.e., individuals who contribute to the scientific development or execution of a project in a substantive, measurable way).

Upon request, applicants must submit the completed Disclosure Form and any additional agency-specific information electronically in eRA Commons via the Just-In-Time (JIT) process as described in the NIH Grants Policy Statement (GPS) Section 2.5.1 Just-in-Time Procedures. Applicants must continue to comply with NIH Other Support disclosure requirements as provided in NIH GPS Section 2.5.1 and may be required to provide similar information on the Disclosure Form for covered individuals identified in the application. If participating in this NOFO, SBC applicants applying to CDC and FDA will follow each agency’s policies for submitting additional documents during the pre-award process. Applicants that do not submit the completed Disclosure Form during the JIT process will be deemed noncompliant and not be considered for funding.

Denial of Awards

Applicants are encouraged to consider whether their entity’s relationships with foreign countries of concern will pose a security risk.Prior to issuing an award, NIH, CDC, and FDA will determine whether the SBC submitting the application:

• has an owner or covered individual that is party to a malign foreign talent recruitment program;
• has a business entity, parent company, or subsidiary located in the People’s Republic of China or another foreign country of concern; or
• has an owner or covered individual that has a foreign affiliation with a research institution located in the People’s Republic of China or another foreign country of concern.

A finding of foreign involvement with countries of concern will not necessarily disqualify an applicant. Final award determinations will be based on the above finding of foreign involvement and whether the applicant’s involvement falls within any of the following risk criteria, per the Act:

• interfere with the capacity for activities supported by NIH, CDC, or FDA to be carried out;
• create duplication with activities supported by NIH, CDC, or FDA;
• present concerns about conflicts of interest;
• were not appropriately disclosed to NIH, CDC, or FDA;
• violate Federal law or terms and conditions of NIH, CDC, or FDA; or
• pose a risk to national security.

Generally, NIH, CDC, and FDA will not provide SBC applicants the opportunity to address any identified security risks prior to award. NIH, CDC, and FDA will not issue an award under the SBIR/STTR program if the covered relationship with a foreign country of concern identified in this guidance is determined to fall under any of the criteria provided.

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access their Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement Section 2.4.4 Disposition of Applications.

Section VI. Award Administration Information

1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" (JIT) information from the applicant as described in the NIH Grants Policy Statement. This request is not a Notice of Award nor should it be construed to be an indicator of possible funding. SBIR and STTR applicants under consideration for award will be required to submit the SBA-issued Required Disclosures of Foreign Affiliations or Relationships to Foreign Countries form during the JIT process. Applicants that fail to submit a Disclosure Form will not be considered for funding.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the recipient's business official.

Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this NOFO will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.

Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities, including of note, but not limited to:

• Federalwide Standard Terms and Conditions for Research Grants
• Prohibition on Certain Telecommunications and Video Surveillance Services or Equipment
• Acknowledgment of Federal Funding

If a recipient is successful and receives a Notice of Award, in accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

If a recipient receives an award, the recipient must follow all applicable nondiscrimination laws. The recipient agrees to this when registering in SAM.gov. The recipient must also submit an Assurance of Compliance (HHS-690). To learn more, see the Laws and Regulations Enforced by the HHS Office for Civil Rights website.

HHS recognizes that NIH research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this NOFO.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to System for Award Management (SAM.gov) requirements. SAM.gov requires Federal agencies to review and consider information about an applicant in the designated integrity and performance system (currently SAM.gov) prior to making an award. An applicant can review and comment on any information in the responsibility/qualification records available in SAM.gov. NIH will consider any comments by the applicant, in addition to the information available in the responsibility/qualification records in SAM.gov, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 2 CFR Part 200.206 “Federal awarding agency review of risk posed by applicants.” This provision will apply to all NIH grants and cooperative agreements except fellowships.

The Office of Inspector General Hotline accepts tips from all sources about potential fraud, waste, abuse and mismanagement in Department of Health & Human Services programs. The reporting individual should indicate that the fraud, waste and/or abuse concerns an SBIR/STTR grant or contract, if relevant. Report Fraud.

Not Applicable

3. Data Management and Sharing

Consistent with the 2023 NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described. SBIR and STTR recipients may retain the rights to data generated during the performance of an SBIR or STTR award for up to 20 years after the award date, per the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) Program Policy Directive. An acceptable Data Management and Sharing plan can reference and incorporate these data rights. Further information about SBIR and STTR data rights are enumerated in the NIH GPS.

4. Reporting

When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

NIH requires that SBIR/STTR recipients submit the following reports within 120 days of the end of the grant budget period unless the recipient is under an extension.

• Final RPPR (requirements have recently changed - please see the NOT-OD-17-085)
• Final Invention Statement and Certification (HHS 568)
• Annual Invention Utilization Reports
• Federal Financial Report (FFR)
• SBIR.gov

The RPPR should include an annual evaluation statement of the PD/PI’s professional progress from the mentor.

Failure to submit timely final reports may affect future funding to the organization or awards with the same PD/PI. NIH NOFOs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 2 CFR 200.301.

The Federal Funding Accountability and Transparency Act of 2006 as amended (FFATA), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All recipients of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over the threshold. See the NIH Grants Policy Statement for additional information on this reporting requirement.

In accordance with the regulatory requirements provided at 2 CFR Part 200, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (Responsibility/Qualification in SAM.gov, formerly FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in 2 CFR Part 200 – Award Term and Condition for Recipient Integrity and Performance Matters.

Disclosure of Foreign Relationships Reporting Requirements

Recipients are responsible for monitoring their relationships with foreign countries of concern post-award, for any changes that may impact previous disclosures. SBCs receiving an award under the SBIR/STTR program are required to submit an updated Disclosure Form to report any of the following changes to NIH, CDC, and FDA throughout the duration of the award:

• any change to a disclosure on the Disclosure Form;
• any material misstatement that poses a risk to national security; and
• any change of ownership, change to entity structure, or other substantial change in circumstances of the SBC that NIH, CDC, and FDA determine poses a risk to national security.

Regular, annual updates are required at the time of all SBIR/STTR annual, interim, and final Research Performance Progress Reports (RPPRs). For changes that occur between RPPR submissions, recipients must request prior approval from NIH for legal actions such as merger, acquisition, and successor-in-interest or any other change in ownership, entity structure, covered individual, or other substantive changes in circumstances no later than 30 days before the proposed change. See NIH Grants Policy Statement 8.1.3 Requests for Prior Approval and NIH Grants Policy Statement 18.5.2.2 Change in Organization Size & Change of Recipient Institution Actions for more details. Disclosure Forms are required for any changes as described above. Recipients are required to upload these updated disclosures using the Additional Materials (AM) tool in eRA Commons. 

If the recipient reports a covered foreign relationship that meets any of the risk criteria prohibiting funding described in this NOFO, NIH, CDC, and FDA may deem it necessary to terminate the award for material failure to comply with the federal statutes, regulations, or terms and conditions of the federal award. Refer to NIH GPS Section 8.5.2 Remedies for Noncompliance or Enforcement Actions: Suspension, Termination, and Withholding of Support for more information. Recipients are encouraged to monitor their covered foreign relationships post-award and avoid entering into relationships, both funded and unfunded, that may pose a security risk and jeopardize their ability to retain their award.

Agency Recovery Authority and Repayment of Funds

An SBC will be required to repay all amounts received from NIH, CDC, and FDA under the award if either of the following determinations are made upon assessment of a change to their disclosure:

• the SBC makes a material misstatement that NIH, CDC, and FDA determine poses a risk to national security; or
• there is a change in ownership, change in entity structure, or other substantial change in circumstances of the SBC that NIH, CDC, and FDA determine poses a risk to national security.

The repayment requirements and procedures provided in Section 8.5.4 Recovery of Funds of the NIH GPS apply and may also be subject to additional noncompliance and enforcement actions as described in Section 8.5.2 of the GPS. Recipients are required to follow the repayment procedures provided in the Guidance for Repayment of Grant Funds to the NIH.

5. Evaluation

In carrying out its stewardship of human resource-related programs, the NIH or CDC may request information essential to an assessment of the effectiveness of this program from databases and from participants themselves. Participants may be contacted after the completion of this award for periodic updates on various aspects of their employment history, publications, support from research grants or contracts, honors and awards, professional activities, and other information helpful in evaluating the impact of the program.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

Finding Help Online: https://www.era.nih.gov/need-help  (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-637-3015

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]

SBA Company Registry (Questions regarding required registration at the SBA Company Registry and for technical questions or issues)
Website to Email: http://sbir.gov/feedback?type=reg

NIH SEED (Small business Education and Entrepreneurial Development)
Telephone: 301-435-2688
Fax: 301-480-0146
Email: [email protected]

Daniel Shaughnessy, PhD
NIEHS - NATIONAL INSTITUTE OF ENVIRONMENTAL HEALTH SCIENCES
Phone: 984-287-3321
E-mail: [email protected]

Lingamanaidu V Ravichandran, PhD
NIEHS - NATIONAL INSTITUTE OF ENVIRONMENTAL HEALTH SCIENCES
Phone: 984-287-3309
E-mail: [email protected]

Meena Rajagopal, Ph.D.
National Center for Advancing Translational Science (NCATS)
Telephone: 301-827-1921
Email: [email protected]

Eddie Billingslea, Ph.D.

National Institute of General Medical Sciences (NIGMS)"
Email: [email protected]
 

Steve Dearwent
National Institute for Occupational Safety and Health (NIOSH)
Telephone: 404-498-6832
Email: [email protected]

Daniel Gossett, Ph.D. 
Division of Kidney, Urologic, & Hematologic Diseases
National Institute of Diabetes and Digestive and Kidney Diseases, NIH
Phone: (301) 569-0395
Email: [email protected] 

Julia Berzhanskaya, PhD
National Heart, Lung, and Blood Institute -  NHLBI
Telephone: 301-443-3703
Email: [email protected]

Stephanie Davis, PhD
National Heart, Lung, and Blood Institute -  NHLBI
Telephone: 301-496-8412
Email: [email protected]

Toyin Ajisafe, PhD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-827-9242
Email: [email protected]

Orlando Lopez, PhD
NIDCR - NATIONAL INSTITUTE OF DENTAL & CRANIOFACIAL RESEARCH
Phone: (301) 402-4243
E-mail: [email protected]

Megan Ryan, M.B.A.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-4225
Email: [email protected]

Allison Dennis, PhD

National Library of Medicine 

[email protected]

Phone: 301-827-9721

Paekgyu Lee
NEI - NATIONAL EYE INSTITUTE
Phone: (301) 435-8164
E-mail: [email protected]

Ian Curtis Nova
NHGRI - NATIONAL HUMAN GENOME RESEARCH INSTITUTE
Phone: none
E-mail: [email protected]

Todd Haim, Ph.D. 
Office of Strategic Extramural Programs (OSEP)
National Institute on Aging (NIA)
Phone: 301-480-8964
Email: [email protected]

Roger Miller
NIDCD - NATIONAL INSTITUTE ON DEAFNESS AND OTHER COMMUNICATION DISORDERS
Phone: 301.402.3458
E-mail: [email protected]

Xibin Wang, PhD
NIAMS - NATIONAL INSTITUTE OF ARTHRITIS AND MUSCULOSKELETAL AND SKIN DISEASES
Phone: 301-451-3884
E-mail: [email protected]

Jessica Michelle Lukacs
NIDA - NATIONAL INSTITUTE ON DRUG ABUSE
Phone: none
E-mail: [email protected]

Emrin Horgusluoglu, Ph.D.
National Center for Complementary & Integrative Health (NCCIH)
Phone: 240-383-5302
Email: [email protected] 

Bill Duval, PhD
National Institute of Nursing Research (NINR)
Email: [email protected]
 

Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).

NIH SEED (Small business Education and Entrepreneurial Development)
Telephone: 301-435-2688
Fax: 301-480-0146
Email: [email protected]

Clark Allen Phillips
NIEHS - NATIONAL INSTITUTE OF ENVIRONMENTAL HEALTH SCIENCES
Phone: (984) 287-3364
E-mail: [email protected]

Imoni Williams, J.D.
National Center for Advancing Translational Science (NCATS)
Telephone: 301-435-2939
Email: [email protected]  

Grants Administration Branch National Institute of General Medical Sciences (NIGMS)
Email: [email protected]

Brownie Anderson-Rana
Centers for Disease Control and Prevention
Phone: 770-488-2771
Email: [email protected]

Angie Willard
Centers for Disease Control and Prevention
Phone: 770-488-2863
Email: [email protected]

Christina Coriz
NIDDK - NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES
Phone: 301-594-8848
E-mail: [email protected]

Andre Walker
National Heart, Lung, and Blood Institute -  NHLBI
Telephone: 301-827-8061
Email: [email protected]

Margaret Young
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-642-4552
Email: [email protected]

Diana Rutberg, MBA
NIDCR - NATIONAL INSTITUTE OF DENTAL & CRANIOFACIAL RESEARCH
Phone: (301) 594-4798
E-mail: [email protected]

Judy Fox
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-4704
Email: [email protected]

Andrea Culhane
National Library of Medicine (NLM)
Phone: 301-402-0069
E-mail: [email protected]

Karen Robinson Smith
NEI - NATIONAL EYE INSTITUTE
Phone: 301-435-8178
E-mail: [email protected]

Zephaun Harvey
NHGRI - NATIONAL HUMAN GENOME RESEARCH INSTITUTE
Phone: 301 435-7859
E-mail: [email protected]

Jessi Perez
National Institute on Aging (NIA)
Phone: 301-402-7739
Email: [email protected]

Samantha Tempchin
National Institute on Deafness and Other Communication Disorders (NIDCD)
Telephone: 301-435-1404
Email: [email protected]

Victoria C Matthews
NIAMS - NATIONAL INSTITUTE OF ARTHRITIS AND MUSCULOSKELETAL AND SKIN DISEASES
Phone: 301-594-5032
E-mail: [email protected]

Pamela G Fleming
NIDA - NATIONAL INSTITUTE ON DRUG ABUSE
Phone: 301-480-1159
E-mail: [email protected]

Debbie Chen
National Center for Complementary and Integrative Health (NCCIH)
Phone: 301-594-3788
Email: [email protected]

Randi Freundlich
National Institute of Nursing Research (NINR)
Telephone: 301-594-5974
Email: [email protected]
 

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 2 CFR Part 200.

The SBIR Program is mandated by the Small Business Innovation Development Act of 1982 (P.L. 97-219), reauthorizing legislation (P.L. 99-443) P.L. 102-564, P.L. 112-81 (SBIR/STTR Reauthorization Act of 2011), as reauthorized and extended under P.L. 114-328, Section 1834, P.L. 115-232, and P.L. 117-183. The basic design of the NIH SBIR Program is in accordance with the Small Business Administration (SBA) SBIR Policy Directive.