Innovations for Healthy Living - Improving Minority Health and Eliminating Health Disparities (R43/R44) is a grant from the National Institutes of Health (NIH) that funds small businesses developing products, processes, or services to improve minority health and reduce health disparities.

Administered through NIBHD and participating institutes including NHLBI, NIBIB, NIDDK, and others, the program uses the SBIR R43/R44 mechanism for Phase I, Phase II, and Fast-Track awards. Eligible technologies must be effective, affordable, and culturally acceptable, targeting populations that experience health disparities. Applications are due by December 10, 2026 (with a letter of intent due 30 days prior).

Eligible applicants are U.S.-based small business concerns.

Expired RFA-MD-24-006: Innovations for Healthy Living - Improving Minority Health and Eliminating Health Disparities (R43/R44 - Clinical Trial Optional) This notice has expired. For NIH, in limited situations, applications may be accepted on a case-by-case basis for a short period after expiration to accommodate NIH late or continuous submission policies . Contact the eRA Service Desk for any submission issues.

Check the NIH Guide for active opportunities and notices. Department of Health and Human Services Part 1.

Overview Information Participating Organization(s) National Institutes of Health ( NIH ) Components of Participating Organizations National Institute on Minority Health and Health Disparities ( NIMHD ) National Heart, Lung, and Blood Institute ( NHLBI ) National Institute of Biomedical Imaging and Bioengineering ( NIBIB ) National Institute of Dental and Craniofacial Research ( NIDCR ) National Institute of Diabetes and Digestive and Kidney Diseases ( NIDDK ) National Institute of Neurological Disorders and Stroke ( NINDS ) Participation Added May 30, 2024 ( NOT-NS-24-077 ) National Institute of Nursing Research ( NINR ) National Center for Advancing Translational Sciences ( NCATS ) Funding Opportunity Title Innovations for Healthy Living - Improving Minority Health and Eliminating Health Disparities (R43/R44 - Clinical Trial Optional) R43 / R44 Small Business Innovation Research (SBIR) Grant - Phase I, Phase II, and Fast-Track March 31, 2025 - This funding opportunity was updated to align with agency priorities.

Carefully reread the full funding opportunity and make any needed adjustments to your application prior to submission. April 04, 2024 - Overview of Grant Application and Review Changes for Due Dates on or after January 25, 2025. See Notice NOT-OD-24-084 November 14, 2023 - Clarification of Implementation of the NIH SBIR and STTR Foreign Disclosure Pre-award and Post-Award Requirements.

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

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

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

Funding Opportunity Number (FON) Companion Funding Opportunity Small Business Technology Transfer (STTR) Grants - Phase I/ * Small Business Technology Transfer (STTR) Grants - Phase II See Section III. 3. Additional Information on Eligibility.

Assistance Listing Number 93. 307, 93. 233, 93.

837, 93. 838, 93. 839, 93.

840, 93. 361, 93. 286, 93.

847, 93. 866, 93. 350, 93.

121, 93.

853 Notice of Funding Opportunity Purpose This Notice of Funding Opportunity (NOFO) invites eligible United States small business concerns (SBCs) to submit Small Business Innovation Research (SBIR) grant applications that propose to develop a product, process or service for commercialization with the aim of improving minority health and/or reducing and ultimately eliminating health disparities in one or more populations that experience health disparities.

Appropriate technologies should be effective, affordable, and culturally acceptable. Open Date (Earliest Submission Date) Letter of Intent Due Date(s) 30 days prior to the application due date Renewal / Resubmission / Revision (as allowed) AIDS - New/Renewal/Resubmission/Revision, as allowed All applications are due by 5:00 PM local time of applicant organization.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date. No late applications will be accepted for this Notice of Funding Opportunity (NOFO). New Date November 17, 2025 per issuance of NOT-OD-26-006 .

Required Application Instructions It is critical that applicants follow the SBIR/STTR (B) Instructions in the How to Apply – Application Guide , except where instructed to do otherwise (in this NOFO or in a Notice from the NIH Guide for Grants and Contracts ). Conformance to all requirements (both in the Application Guide and the NOFO) is required and strictly enforced.

Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 1. Overview Information Part 2. Full Text of Announcement Section I.

Notice of Funding Opportunity Description Section II. Award Information Section III. Eligibility Information Section IV.

Application and Submission Information Section V. Application Review Information Section VI. Award Administration Information Section VII.

Agency Contacts Section VIII. Other Information Part 2. Full Text of Announcement Section I.

Notice of Funding Opportunity Description Despite continued improvement in the health of the U.S. population with the introduction of medical and scientific advances, there continues to be an alarming disproportionate burden of illness among certain population groups.

The mission of the NIMHD is to lead scientific research aimed at the development of innovative diagnostics, treatments, and prevention strategies to improve minority health and reduce health disparities in NIH-designated populations that experience health disparities in the United States and its territories.

NIMHD focuses on all aspects of health and health care for racial and ethnic minority populations in the U.S. and the full continuum of health disparity causes as well as the interrelation of these causes.

The purpose of the Notice of Funding Opportunity (NOFO ) is to engage and support small businesses in providing seed (i.e., early-stage investment) funding for developing technologies, services, and products that engage, empower, and motivate individuals and communities, including providers and healthcare institutions that focus on African Americans, Hispanics, American Indians and Alaska Natives, Asian Americans, Native Hawaiians and Pacific Islanders, disadvantaged socioeconomic groups, underserved rural populations.

In using this funding recipients will hopefully lay the groundwork for sustainable health promoting activities and interventions that lead to improved health, healthcare delivery, and the elimination of health disparities.

Other considerations relevant to the technology and products and the organization should include: Effectiveness in improving the current quality of care or research access for populations that experience health disparities. Affordability for the population with existing community resources or an organization’s existing infrastructure. Acceptability such as health literacy, language, and cultural competency considerations.

Physical Barriers – Factors such as proximity to healthcare facilities and transportation may limit access to healthcare. Knowledge Barriers - Health literacy and language barriers inhibiting healthcare delivery and patient information.

Infrastructure Barriers - Health providers, such as rural health clinics, federally qualified health centers, and critical access hospitals, may not have the same resources and expertise of large hospitals and health networks. Economic Barriers - Lack of public and private insurance coverage or financial resources Cultural Barriers - Beliefs and practices shared among social and organizational groups.

Specific Areas of Research Interest Technologies, services, and products that might achieve the objectives of this initiative include, but are not limited to: Facilitate or enhance disease self-management, patient-healthcare provider, or system communication, and/or care coordination between primary care providers, family care givers, hospital emergency department staff, specialty physicians, dental health professionals, nurse practitioners, providers of mental health and behavioral health services, patient navigators, etc., in medically underserved communities and regions.

Culturally attuned behavioral or evidenced-based interventions that empower and promote opportunities for individuals, families, social networks, and communities to engage in health-seeking behaviors and health-promoting activities (diet choice, exercise/physical activity, oral hygiene, medication adherence, child immunizations, etc.) and to avoid risky behaviors (smoking, vaping, alcohol/drug misuse, unsafe sex, etc.).

Detecting, measuring, and assessing a broad array of unhealthy social and environmental exposures (discrimination, stress, pollutants, allergens, noise, crime, etc.), and for characterizing cumulative exposures across multiple individuals and communities and linking this information to physiological responses and health indicators at the individual and population levels.

These technologies may include efforts to improve and standardize data collection and the integration of social determinants of health (SDOH) and other data across disparate data sources, including clinical patient data, electronic medical records, public health data, census data, housing data, employment data, and crime statistics.

Utilizing NIH data systems, such as ScHARe ( S cience C ollaborative for H ealth Disparities and A rtificial intelligence bias RE duction ), the All of Us Research Hub or other data services, or other NIH Data repositories.

Utilizing cutting-edge digital health care and research technologies and approaches, such as digital therapeutics, decentralized and digital clinical trials, and remote devices for providing health care and the engagement, recruitment, and retention of a variety of populations.

The development of services and products that strengthens infrastructure and workforce for delivering care and clinical research that increase the participation of patients and participants and expands access. Engage, empower, and motivate individuals, families , and communities to enhance the quality of life and to sustain health gains.

Culturally appropriate survey instruments, tools, modules, and databases to promote community-based research engaging populations that experience health disparities. Culturally appropriate, evidence-based health empowering promotion and disease prevention educational media , such as software, informational videos, and printed materials.

Innovative software, tools and technology for science and health education curriculum materials, interactive teaching aids, serious and applied games, models for classroom instruction for K-12 and undergraduate students , and the public.

Mobile health (mHealth) and telehealth/telemedicine technologies and apps for i mproving communication among health care providers and between patients, families, and physicians and healthcare providers, medication adherence, diagnosis, monitoring, evaluation, medical management, screening, tracking, and treatment in underserved community settings and rural and remote locations.

Promote big data science or enhance data scientist training to address health disparities and/or minority health research, for example software or tools developed to link social determinants of health easily (e.g., years of education, race/ethnicity, etc.) with massive datasets such as electronic medical record (EMR), genomic information, census data, national surveys, and other state or community-level data sources.

Such technology will be instrumental in understanding fundamental causes of health disparities and developing meaningful interventions. Linking family medical histories and family ancestries. Technologies for clinical trials and biobanking, such as the rapid identification in human specimens (e.g., blood, buccal swabs, etc.) of genes and/or genomic variants of known importance to minority health.

Educating prospective social entrepreneurs, and minority and health disparity communities on how to transition technologies from the bench to the bedside. Promoting precision medicine and other precision-based strategies such as utilizing All of Us Research Program research tools.

Leveraging electronic health records and communication technologies to deliver and evaluate interventions that reduce health disparities by removing accessibility and health literacy barriers, facilitating population tailoring and personalization, and decreasing cost. Understanding the causes of health disparities and associated variables such as SDOH for preventing one or more health disparities.

Using systems modeling, artificial intelligence, or other techniques to predict relationships between health disparities and health determinants and to assess health disparities interventions outcomes.

Creating and testing tailored algorithms that identify interventions tailored, target, and optimized for implementation in specific communities for reducing or eliminating disparities in one or more specific health condition, disease, or health outcome. Leveraging robotic and autonomous systems for improving health, and preventing, reducing, and eliminating health disparities.

Preventing and minimizing adverse exposures and health risks (post-traumatic stress) or promoting health, well-being, resilience, and recovery resulting from disasters or the threat of a disaster. Disasters may include public health threats such COVID-19 or a similar pandemic.

Examples may include new tools, apps, education, curricula, or other technologies to detect, screen, treat, or prevent or otherwise mitigate adverse health outcomes or leverage community and or population resilience and prevention efforts IC-Specific Areas of Research Interest Topics of Interest to NHLBI : The NHLBI is interested in funding the development of diagnostic tools, monitoring and informatics devices, wearable technologies, mobile applications, and other digital health and wellness tools to improve heart, lung, blood, and sleep (HLBS) health in historically underserved, low-resource, and remote communities.

The NHLBI also encourages the use of novel technological approaches and business models to improve health in these communities by addressing usability issues that are present with current technological approaches.

Examples of disorders and conditions of interest to NHLBI include, but are not limited to: Hypertension, Congestive Heart Failure, Coronary Artery Disease, Stroke/Cerebrovascular Disease, Asthma, Chronic Obstructive Pulmonary Disease, Pulmonary Fibrosis, Pulmonary Hypertension, Lymphangioleiomyomatosis (LAM), Sarcoidosis, Obstructive Sleep Apnea, Sickle Cell Disease, anemia, thrombosis and coagulopathy, and HLBS-related complications of Acquired Immunodeficiency Syndrome (AIDS).

In addition to these disorders and conditions, NHLBI also seeks applications that address issues that are more common or cause high morbidity and mortality in women throughout the life course including pregnancy and/or the post-partum period such as cardiovascular complications, deep vein thrombosis, and postpartum hemorrhage.

The NHLBI also encourages applications focused on the development of point-of-care and/or low-cost wearable devices that continuously monitor multiple HLBS biomarkers or environmental factors in home-care settings.

In addition to the above conditions, the NHLBI has a strong interest in supporting innovative uses of technology to engage communities in their health, including evidence-based management of HLBS diseases and the prevention of HLBS diseases.

Additionally, the NHLBI is interested in supporting the development of tools and technologies that will address barriers to uptake of the implementation and dissemination of evidence-based interventions for HLBS conditions and disorders in minority and low-income communities.

These tools may include but are not limited to software programs, mobile applications, and services to improve health literacy, promote awareness of lifestyle interventions for HLBS health, increase access and promote adherence to evidence-based interventions. A complete list of NHLBI scientific focus areas is found at: https://www. nhlbi.

nih. gov/science . Topics of interest to NIA: The NIA is interested in the NOFO topics as they pertain to improving the health and wellbeing of aging adults in NIH-defined population groups who experience health disparities.

Applicants should reference the NIA Health Disparities Research Framework to facilitate identifying and proposing tools, technologies, and products that are effective, accessible, and culturally acceptable by the intended health disparity population(s) and which reflect the life course perspective or theory, as well as relevant levels of analysis among the different domains described in the NIA Health Disparities Research Framework.

NIA has a special interest in research and development proposals to: Develop accurate and effective preventive, diagnostic, or therapeutic approaches to identify, predict, and reduce racial and ethnic disparities in clinical outcomes for aging populations. Develop technologies to ameliorate the social, structural, economic, and behavioral determinants of health disparities.

Study biological determinants of health disparities and develop technologies and products that address them. Study social determinants of health disparities and develop technologies and products that mitigate bias and more accurately predict health outcomes of racial and ethnic underrepresented groups of older adults.

For example, creating, testing, and validating unbiased algorithms that can be broadly applied to tools and technologies to improve the health and wellbeing of aging health disparity priority population(s). For a list of health disparity priority populations, please refer to the NIA Health Disparities Research Framework.

Increase participation of racial and ethnic minority populations in AD/ADRD clinical trials to compliment and/or leverage existing efforts such as the NIA’s Alzheimer’s Disease Research Centers , Alzheimer’s Clinical Trials Consortium , and the National Strategy for Recruitment and Participation in Alzheimer's and Related Dementias Clinical Research .

Conduct clinical trial research leveraging mechanism-focused intervention development research at Stages I through V of the NIH Stage Model for Behavioral Intervention Development to address the care needs and promote the health, function, and well-being of racial and ethnic underrepresented groups of older adults.

This includes the development, testing, and validation of scalable solutions that can be designed and delivered for use at the individual, family, dyad, group, community, or health-systems level. For additional information on seeking NIA support and investigative resources for clinical trial research, visit https://www. nia.

nih. gov/research/clinical-trials#investigators . For additional information on NIA SBIR areas of interests, please refer to https://www.

nia. nih. gov/research/sbir/nia-small-business-research-priorities .

Applications must be responsive to this NOFO and explicitly address minority health or health disparities as it pertains to the NIA mission and research interests.

Topics of Interest to NIAAA: The NIAAA is interested in the above topics for this NOFO as they pertain to Alcohol Use Disorder and alcohol-related problems including the development of tools and technologies to address the barriers of the implementation and dissemination of evidence-based interventions in minority or low-income communities.

Applicants are strongly encouraged to contact the NIAAA SBIR Coordinator at [email protected] prior to grant submission. Topics of Interest to NIBIB: The NIBIB is interested in the above topics for this NOFO as they pertain to NIBIB mission. NIBIB interests include the development and integration of advanced bioengineering, sensing, imaging, and computational technologies for the improvement of human health and medical care.

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

However, applicants may propose research that utilizes only a single tissue, organ, or physiological condition as a model system to facilitate the development of what is expected to be a more broadly applicable enabling technology.

Potential applicants are encouraged to send a draft specific aims page to the NIBIB Small Business Program ( [email protected] ) to determine if their research fits within the NIBIB mission and scientific program areas of interest. NIBIB funding of clinical trials will be in accordance with NOT-EB-21-005 "NIBIB Guidance for Support of Clinical Trial Applications."

Briefly, NIBIB will only support mission-focused (see NIBIB's program areas) early-stage clinical trial applications, i.e., feasibility, Phase I, first-in-human, safety, or other small clinical trials, that inform early-stage technology development. NIBIB will not support applications proposing pivotal, Phase II, III, IV, or trials in which the primary outcome is efficacy, effectiveness, or a post-market concern.

Also, mechanistic trials are not supported unless the primary focus of the project is on technology development.

Topics of Interest to NIDCR: The NIDCR is interested in supporting development of use-inspired technologies and products that promote dental, oral, and craniofacial (DOC) health and enhance effectiveness, acceptability, access, affordability, and sustainability of DOC health care and self-management in populations disproportionately affected by DOC diseases and conditions.

NIDCR’s areas interest include, but are not limited to: Enhancing efficiency, quality, and patient-centeredness in team-based DOC health care. Detecting, measuring, assessing, and addressing discriminations in the DOC health system.

Creating and testing statistical models and algorithms to predict DOC health risks taking into account the influence of social determinants to advance personalized DOC health care delivery that improves clinical outcomes. Creating community-level opportunities to address DOC health determinants and enable DOC health promoting lifestyles in underserved communities.

Aiding long-term adherence to DOC health recommendations and self-management capacity. NIDCR does not use the SBIR/STTR mechanism to support clinical trials. Topics of Interest to NIDDK: The NIDDK is interested in the above topics as they pertain to diabetes and other endocrine and metabolic diseases; digestive diseases, nutritional disorders associated with NIDDK diseases, and obesity; and kidney, urologic, and hematologic diseases.

To be assigned to the NIDDK, applications must be directly related to the mission of the NIDDK ( https://www. niddk. nih.

gov/about-niddk/meet-director/mission-vision ) Topics of Interest to NCATS: The NCATS strives to develop innovations to reduce, remove or bypass costly and time-consuming bottlenecks in the translational research pipeline to speed the delivery of new drugs, diagnostics and medical devices to patients.

Projects of most interest to NCATS include those that focus on drug discovery and development, biomedical, clinical and health research informatics and clinical, dissemination and implementation research. Applicants are strongly encouraged to contact the program staff at [email protected] prior to submitting an application. For additional information on NCATS SBIR areas of interest, please refer to https://ncats.

nih. gov/smallbusiness/priorities . Please note that the NCATS SBIR program does not support applications that include clinical trials.

Topics of Interest to NINR: The NINR supports research aligned with our mission and strategic priorities, conducted by scientists from any discipline. NINR discovers solutions to health challenges through the lenses of health disparities, social determinants of health, population and community health, prevention and health promotion, and systems and models of care.

Drawing on the strengths of nursing’s holistic, contextualized perspective, core values, and broad reach, NINR funds multilevel and cross-sectoral research that examines the factors that impact health across the many settings in which nurses practice, including homes, schools, workplaces, clinics, justice settings, and the community.

Applications that do not explicitly address minority health or health disparities will be considered not responsive to the NOFO and will not be peer reviewed. Potential applicants are encouraged to discuss their project with the appropriate IC Scientific Contact. See Section VIII.

Other Information for award authorities and regulations. Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs. Section II.

Award Information Grant: A financial assistance mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity. Application Types Allowed New (Phase I, Fast-Track, Direct Phase II) Resubmission (All Phases) The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for the NOFO.

Optional: Accepting applications that either propose or do not propose clinical trial(s) Need help determining whether you are doing a clinical trial? Funds Available and Anticipated Number of Awards The following NIH components intend to commit the following amounts in FY 2024: NIMHD, up to $1,000,000 total costs, 3-4 awards. NHLBI, up to $2,900,000 total costs, 3 Phase I and one Direct-to-Phase II.

NIA, up to $1,500,000 total costs, 3-4 awards. NIAAA, up to $600,000 total costs, 1-2 awards. NIBIB, up to $600,000 total costs, 1-2 awards.

NIDCR, up to $250,000 total costs, 1 award. NIDDK, up to $1,000,000 total costs, 1-3 awards. NINDS, up to $1,000,000 total costs, 1-3 awards.

NCATS, up to $1,000,000 total costs, 1-3 awards. Total funding support (direct costs, indirect costs, fee) normally may not exceed $306,872 for Phase I awards and $2,045,816 for Phase II awards. NIH has received a waiver from SBA, as authorized by statute, to exceed these total award amount hard caps for specific topics.

The current list of approved topics can be found at https://seed. nih. gov/sites/default/files/HHS_Program_Descriptions.

pdf . For applications that fit the approved waiver topics, the NIA will not fund applications above $500,000 total costs in Phase I and $2. 5M in Phase II.

Applicants are strongly encouraged to contact program officials prior to submitting any application more than the hard caps listed above and early in the application planning process. In all cases, applicants should propose a budget that is reasonable and appropriate for completion of the research project. According to statutory guidelines, award periods normally may not exceed 6 months for Phase I and 2 years for Phase II.

Applicants are encouraged to propose a project duration period that is reasonable and appropriate for completion of the research project. NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this NOFO. Section III.

Eligibility Information Only United States small business concerns (SBCs) are eligible to submit applications for this opportunity. A small business concern is one that, at the time of award of Phase I and Phase II, meets all of the following criteria: 1.

Is organized for profit, with a place of business located in the United States, which operates primarily within the United States or which makes a significant contribution to the United States economy through payment of taxes or use of American products, materials or labor; 2.

Is in the legal form of an individual proprietorship, partnership, limited liability company, corporation, joint venture, association, trust or cooperative, except that where the form is a joint venture, there must be less than 50 percent participation by foreign business entities in the joint venture; SBIR and STTR.

Be a concern which is more than 50% directly owned and controlled by one or more individuals (who are citizens or permanent resident aliens of the United States), other business concerns (each of which is more than 50% directly owned and controlled by individuals who are citizens or permanent resident aliens of the United States), an Indian tribe, ANC or NHO (or a wholly owned business entity of such tribe, ANC or NHO), or any combination of these; OR SBIR-only.

Be a concern which is more than 50% owned by multiple venture capital operating companies, hedge funds, private equity firms, or any combination of these.

No single venture capital operating company, hedge fund, or private equity firm may own more than 50% of the concern, unless that single venture capital operating company, hedge fund , or private equity firm qualifies as a small business concern that is more than 50% directly owned and controlled by individuals who are citizens or permanent resident aliens of the United States; OR SBIR and STTR.

Be a joint venture in which each entity to the joint venture must meet the requirements set forth in paragraph 3 (i) or 3 (ii) of this section. A joint venture that includes one or more concerns that meet the requirements of paragraph (ii) of this section must comply with § 121. 705(b) concerning registration and proposal requirements.

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.

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 SF424 (R&R) SBIR/STTR 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