NOT-NS-22-067: Notice of NINDS Participation in RFA-MD-22-004 "Innovations for Healthy Living - Improving Minority Health and Eliminating Health Disparities (R43/R44

Notice of NINDS Participation in RFA-MD-22-004 "Innovations for Healthy Living - Improving Minority Health and Eliminating Health Disparities (R43/R44 - Clinical Trial Optional)".

Notice Number:

NOT-NS-22-067

Key Dates

Release Date:

February 4, 2022

Related Announcements

RFA-MD-22-004 - Innovations for Healthy Living - Improving Minority Health and Eliminating Health Disparities (R43/R44 - Clinical Trial Optional)

Issued by

National Institute of Neurological Disorders and Stroke (NINDS)

Purpose

The purpose of this notice is to inform applicants of NINDS' participation in RFA-MD-22-004 "Innovations for Healthy Living - Improving Minority Health and Eliminating Health Disparities (R43/R44 - Clinical Trial Optional)" effective immediately. Changes to the Funding Opportunity Announcement (FOA) are shown below.

Currently Reads:

Part 1. Overview Information

Components of Participating Organizations

National Institute on Minority Health and Health Disparities (NIMHD)

National Heart, Lung, and Blood Institute (NHLBI)

National Institute on Aging (NIA)

National Institute of Biomedical Imaging and Bioengineering (NIBIB)

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

National Institute on Drug Abuse (NIDA)

National Institute of Mental Health (NIMH)

National Center for Advancing Translational Sciences (NCATS)

Assistance Listing Number:

93.307, 93.847, 93.286, 93.350, 93.837, 93.838, 93.839, 93.840, 93.233, 93.866, 93.279, 93.242

Section I. Funding Opportunity Description

Specific Areas of Research Interest

Technologies 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.
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 general public.
Mobile health (mHealth) and telehealth/telemedicine technologies and apps for improving 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 inequities 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.

Topics of Interest to NCATS: 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 program staff at NCATS-SBIRSTTR@mail.nih.gov 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 accept applications that include clinical trials.

Topics of Interest to NHLBI: The NHLBI is interested in funding the development of disease diagnostics and monitoring devices, wearable technologies, mobile applications, and other tools to improve heart, lung, blood, and sleep (HLBS) health in historically underserved, low-resource, and remote communities. 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, Obstructive Sleep Apnea, Sickle Cell Disease, and HLBS-related complications of Acquired Immunodeficiency Syndrome (AIDS).

In addition to the above conditions, the NHLBI is also interested in funding 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. A complete list of scientific focus areas in the NHLBI can be found at:https://www.nhlbi.nih.gov/science.

Topics of Interest to NIA: The NIA is interested in each of the above topics for this FOA as they pertain to Alzheimer’s Disease and Related Dementias.

Topics of Interest to NIBIB: The NIBIB is interested in the above topics for this FOA 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 function 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 contact the appropriate Program Director in their scientific program area of interest (https://www.nibib.nih.gov/research-funding) to determine if their research fits within the NIBIB mission.

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 NIDA: NIDA is interested in the FOA topics as they pertain to prevention, management, monitoring, diagnosis, and treatment of Substance Use Disorders (e.g., Opioid Use Disorder, Stimulant Use Disorder) and are congruent to NIDA’s mission (https://www.drugabuse.gov/about-nida/strategic-plan/nidas-mission).

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 NIMH: The NIMH is interested in each of the above topics for this FOA as they pertain to the treatment and prevention of serious mental illness.

Applications Not Responsive to the FOA: Applications that do not explicitly address minority health or health disparities will be considered non-responsive and will not be reviewed. Potential applicants are encouraged to discuss responsiveness with the Scientific Contact.

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

Section II. Award Information

Funds Available and Anticipated Number of Awards

The following NIH components intend to commit the following amounts in FY 2022 or 2023:

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 $1,000,000 total costs, 3-4 awards.

NIBIB, up to $1,000,000 total costs, 3-4 awards.

NIDA, up to $1,000,000 total costs, 1-3 awards.

NIMH, up to $250,000 total costs, 1 award.

NIDDK, up to $1,000,000 total costs, 1-3 awards.

Award Budget

Total funding support (direct costs, indirect costs, fee) normally may not exceed $259,613 for Phase I awards and $1,730,751 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://sbir.nih.gov/funding#omni-sbir. Navigate to the “Program Descriptions and Research Topics” document, Appendix A or the current "SBA approved topics list for budget waivers."

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.

For applications that fit approved waiver topics, NIBIB will not fund applications above $275,000.00 total costs in Phase I and $1.8M in Phase II.

Applicants are strongly encouraged to contact program officials prior to submitting any application in excess of 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.

Section VII. Agency Contacts

Scientific/Research Contacts

LCDR Michael Banyas, USPHS, MPA
National Insitute on Minority Health and Health Disparities(NIMHD)
Phone: 301-827-7478
Email: Michael.Banyas@nih.gov

Daniel Gossett, Ph.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Phone: 301-594-7723
E-mail: daniel.gossett@nih.gov

Adam Haim
National Institute of Mental Health (NIMH)
Telephone: 301-435-3593
Email: haima@mail.nih.gov

Lillianne M Portilla
National Center For Advancing Translational Sciences (NCATS)
Phone: 301-827-7170
E-mail: portilll@mail.nih.gov

Julia Berzhanskaya
National Institute On Drug Abuse (NIDA)
Phone: 301-594-6140
E-mail: julia.berzhanskaya@nih.gov

Ilana Grace Goldberg
National Institute Of Biomedical Imaging And Bioengineering (NIBIB)
Phone: 301.402.3465
E-mail: ilana.goldberg@nih.gov

Joy Toliver, M.P.H.
National Institute on Aging (NIA)
Phone: 301-451-6374
Email: joy.toliver@nih.gov

Stephanie Meyers Davis
National Heart, Lung, And Blood Institute (NHLBI)
Phone: none
E-mail: stephanie.davis3@nih.gov

Financial/Grants Management Contact(s)

Priscilla Grant, JD
National Institute on Minority Health and Health Disparities (NIMHD)
Phone: 301-594-8412
Email: grantp@mail.nih.gov

Pamela Love
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Phone: 301-435-6198
E-mail: pamela.love@nih.gov

Jane Lin
National Institute of Mental Health (NIMH)
Telephone: 301-443-2229
Email: linja@mail.nih.gov

Shannon Oden
National Center For Advancing Translational Sciences (NCATS)
Phone: 301.594.3028
E-mail: odens@mail.nih.gov

Amy Connolly
National Institute On Drug Abuse (NIDA)
Phone: (301) 827-4457
E-mail: connolla@mail.nih.gov

James E Huff
National Institute Of Biomedical Imaging And Bioengineering (NIBIB)
Phone: 301-451-4786
E-mail: huffj@mail.nih.gov

Jessi Perez
National Institute on Aging (NIA)
Phone: 301-402-7739
Email: jessi.perez@nih.gov

Annmarie Brasilemejac
National Heart, Lung, And Blood Institute (NHLBI)
Phone: (301) 827-8016
E-mail: brasilea@nhlbi.nih.gov

Modified to Read:

Part 1. Overview Information

Components of Participating Organizations

National Institute on Minority Health and Health Disparities (NIMHD)

National Heart, Lung, and Blood Institute (NHLBI)

National Institute on Aging (NIA)

National Institute of Biomedical Imaging and Bioengineering (NIBIB)

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

National Institute on Drug Abuse (NIDA)

National Institute of Mental Health (NIMH)

National Institute of Neurological Disorders and Stroke (NINDS)

National Center for Advancing Translational Sciences (NCATS)

Assistance Listing Number:

93.307, 93.847, 93.286, 93.350, 93.837, 93.838, 93.839, 93.840, 93.233, 93.866, 93.279, 93.242, 93.853

Section I. Funding Opportunity Description

Specific Areas of Research Interest

Technologies 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.
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 general public.
Mobile health (mHealth) and telehealth/telemedicine technologies and apps for improving 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 inequities 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.

Topics of Interest to NIA: The NIA is interested in each of the above topics for this FOA as they pertain to Alzheimer’s Disease and Related Dementias.

Topics of Interest to NIMH: The NIMH is interested in each of the above topics for this FOA as they pertain to the treatment and prevention of serious mental illness.

Topics of Interest to NINDS: The National Institute for Neurological Disorders and Stroke (NINDS) is interested in topics as they pertain to stroke, vascular contributions to cognitive impairment and dementia (VCID), dementia, epilepsy, Parkinson's Disease, TBI, pain, and other neurological disorders. For proposals focusing on Alzheimer’s Disease and Related Dementias (AD/ADRD), note that NIA and NINDS have shared interest, with NINDS as the lead for VCID, lewy body dementia (LBD), and frontotemporal lobar degeneration (FTLD); and NIA as the lead for applications focused on Alzheimer’s Disease.

The small business program at NINDS is used to achieve the mission of the Institute by supporting innovative ideas at different stages of development, including applied bench research, translational research, and early-stage clinical trials. NINDS is interested in funding exploratory/developmental research applications that propose to study the development, validation, feasibility, and effectiveness of innovative digital health technologies [e.g., mobile health (mhealth), telemedicine and telehealth, health information technology (IT), and remote monitoring devices]. These technologies should have application to address access, reach, delivery, effectiveness, scalability or sustainability of interventions that target health inequity experienced by marginalized populations.

NINDS highly encourages inclusion of community-based participatory research in applications to this RFA. The participatory research process is such that community members, persons affected or impacted, public health and policy professionals, and other key stakeholders in the community’s health have the opportunity to be full participants in each phase of the research. This facilitates the bidirectional transfer of knowledge and skills and the creation of appropriate and effective interventions. For studies involving human subjects, appropriate linguistic and cultural competence strategies should be incorporated to enable recruitment and retention of racial/ethnic minoritized populations. Projects are encouraged to involve community partners collaborators. Applicants are expected to demonstrate their ability to leverage existing partnerships (such as with Tribal governments and organizations, academic and community medical centers or health systems, safety-net health or social service systems, Federally Qualified Health Centers, grassroots organizations, public health departments, community and faith-based organizations, and schools or child-care settings) to complete the study aims. Applicants are encouraged to provide evidence of relationship development or collaboration with community partners with whom they will work, such as through letters of support. The roles of all partners should be clearly articulated, and budgeting should reflect the level of engagement of community partners.

NINDS encourages applications that can demonstrate how the composition of the core leadership team includes diverse representation (e.g. ethnic, racial, gender, career stage, insitution type, geographic location, or persons with disability).

For those applications that propose a clinical trial and use an FDA-regulated intervention, NINDS will give priority to those applications with (a) A protocol submitted under an open IND and the IND is not under full or partial hold. (b) A protocol submitted as an original IDE or as a new study under an open IDE, and FDA has fully approved the IDE or IDE supplement. (c) A protocol submitted under an IND and is on full or partial hold. (d) A protocol submitted as an original IDE or as a new study under an open IDE, and FDA has conditionally approved the IDE or IDE supplement. (e) A protocol is exempt from an IND. (f) A protocol is either exempt from the IDE regulations or does not require IDE approval because it is determined to be nonsignificant risk.

NINDS may decline funding of any application that includes human subjects for programmatic or administrative reasons. SBIR applicants considering projects involving human subjects research are strongly encouraged to contact program staff early in the process of preparing a submission.

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

Section II. Award Information

Funds Available and Anticipated Number of Awards

The following NIH components intend to commit the following amounts in FY 2022 or 2023:

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 $1,000,000 total costs, 3-4 awards.

NIBIB, up to $1,000,000 total costs, 3-4 awards.

NIDA, up to $1,000,000 total costs, 1-3 awards.

NIMH, 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.

Award Budget

Total funding support (direct costs, indirect costs, fee) normally may not exceed $259,613 for Phase I awards and $1,730,751 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 athttps://sbir.nih.gov/funding#omni-sbir. Navigate to the “Program Descriptions and Research Topics” document, Appendix A or the current "SBA approved topics list for budget waivers."

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.

For applications that fit approved waiver topics, NIBIB will not fund applications above $275,000.00 total costs in Phase I and $1.8M in Phase II.

For applications that fit approved waiver topics, NINDS will not fund applications above $700,000 total costs in Phase I and $3M in Phase II.