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PA-22-178 - PHS 2022-2 Ominubus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clincial Trial Not Allowed)

PA-22-179 - PHS 2022-2 Ominubus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clincial Trial Required)

Issued by

National Institute of Environmental Health Sciences (NIEHS)

National Eye Institute (NEI)

National Heart, Lung, and Blood Institute (NHLBI)

National Institute on Aging (NIA)

National Institute of Allergy and Infectious Diseases (NIAID)

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

National Institute of Mental Health (NIMH)

National Institute of Nursing Research (NINR)

National Institute on Minority Health and Health Disparities (NIMHD)

National Center for Advancing Translational Sciences (NCATS)

Purpose

The National Institute of Environmental Health Science (NIEHS), in partnership with Fogarty International Center (FIC), National Institute of Minority Health and Health Disparities (NIMHD), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute of Mental Health (NIMH), National Institute of Nursing Research (NINR), National Heart Blood and Lung Institute (NHBLI) and National Institute of Allergy and Infectious Disease (NIAID), is leading an NIH-wide Climate Change and Health Initiative (CCHI) with the goals of: reducing the health threats posed by climate change across the lifespan. improving the health of people who are disproportionately affected by climate change impacts; and building health resilience among individuals, communities, and nations around the world. As a part of this CCHI, this NOSI encourages Phase I (R41), and Direct to Phase II (R42) STTR grant applications from SBCs to develop commercializable tools, resources, and approaches to capture the effects of climate change and the associated impacts of extreme weather events on human health and to support adaptation or mitigation strategies to minimize health hazards and impacts from climate change. Technologies may include new approaches for detecting climate change-associated exposures, including temperature and air quality, training tools on climate change and mitigation strategies for patients with underlying health conditions, intervention approaches for reducing contaminants water or in indoor air, modeling and prediction tools for climate-change-related weather events and related health effects, and technologies for delivery of health care, including mental health services to communities during extreme weather events.

Background

Climate change poses substantial threats to human health across a wide range of illnesses and injuries, including asthma, respiratory allergies and airway diseases, cardiovascular disease and stroke, heat-related illness and deaths, reproductive, birth outcomes and developmental effects, mental illness, and extreme weather-related morbidity and mortality. Strong evidence indicates that climate change also disproportionately adversely affects communities that experience socioeconomic, behavioral, and environmental vulnerabilities. Such communities include underserved and health disparity populations, especially racial and ethnic minority populations , underserved rural populations, less privileged socioeconomic status (SES) populations, sexual and gender minorities (SGM), and those unduly burdened by exposure to environmental pollution. In addition to the need for research on understanding the effects of these emerging threats on human health, there is a significant need for adaptation efforts to reduce the hazards and negative impacts of climate change on human health. Development of innovative tools, technologies, and methodologies on climate change and health will significantly increase the potential for understanding the complex drivers of adverse health outcomes and enable effective and impactful interventions.

Objectives

Areas of interest and examples of applications that are responsive to this NOSI include, but are not limited to, development of technologies from these Institutes and Centers:

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. https://www.niehs.nih.gov/research/supported/translational/sbir/index.cfm

• Water quality measurement technologies e.g., monitoring the release of harmful industrial chemicals in floods or the concentration of toxic metals, pesticides in source water in drought conditions.
• Disaster Response technologies sensors and exposure assessment tools before, during and after extreme weather events. Technologies that assist in the training and education of workers and their communities addressing the hazards associated with climate change. Data sharing platforms to rapidly share disaster response information across local, municipal, state and/or national levels.
• Sampling technologies that collect/preserve samples (air, water, soil) for later analysis to assess extent of climate change-related contamination events.
• Approaches to capture the mental health status of psychiatric conditions in communities affected by extreme weather events and climate changes, including communities that are most vulnerable to these effects impact (multiple ICs).
• Training tools on climate change and mitigation strategies and STEM education related to changing climates.
• Modeling and prediction tools for climate-related extreme weather events to improve our ability to use data-driven technologies to understand the impacts of climate change on human health and disease (multiple ICs).
• Prediction and modeling tools for harmful algal blooms.
• Technologies for purifying household drinking water in response to flooding and extreme weather events and rapid detection technologies for drinking water quality.
• Technologies for purifying indoor air in response to wildfires and other extreme weather events.

NIEHS and NHLBI

• Sensors and biomonitoring technologies for climate change-related exposures (e.g., temperature, air pollution, mold and fungal toxins related to lung and cardiovascular diseases).
• Technologies to protect at-risk patients from environmental stressors including extreme heat events and fine particulate matter (e.g., more comfortable masks/respirators, inhalers, etc.).
• Translational in vitro microphysiological science (MPS) tools for evaluating the effects of environmental pollutants (PM2.5, mold and fungal toxins, ozone, etc.) and other climate change-related factors on cardiac and pulmonary function.

NHLBI

The National Heart, Lung, and Blood Institute (NHLBI) provides global leadership for a research, training, and education program to promote the prevention and treatment of heart, lung, and blood diseases and enhance the health of all individuals so that they can live longer and more fulfilling lives.

The NHLBI stimulates basic discoveries about the causes of disease, enables the translation of basic discoveries into clinical practice, fosters training and mentoring of emerging scientists and physicians, and communicates research advances to the public. It creates and supports a robust, collaborative research infrastructure in partnership with private and public organizations, including academic institutions, industry, and other government agencies. The Institute collaborates with patients, families, health care professionals, scientists, professional societies, patient advocacy groups, community organizations, and the media to promote the application of research results and leverage resources to address public health needs. The NHLBI also collaborates with international organizations to help reduce the burden of heart, lung, and blood diseases worldwide. NHLBI Small Business Programs | Seed (nih.gov)

• Apps or tools to provide information to patients on current environmental risks (e.g., high temperatures, air quality alerts, asthma triggers etc.) that might adversely affect heart, lung, blood, and sleep health.
• Technologies for addressing blood shortages that might occur due to increased prevalence of vector-borne diseases (i.e., blood purification technologies).
• Educational tools to improve awareness of the adverse effects of extreme weather events on heart, lung, blood, and sleep health.

NEI

The mission of the National Eye Institute (NEI) is to eliminate vision loss and improve quality of life through vision research. NEI is interested in developing novel tools, therapies, and diagnostics to treat diseases and disorders of the visual system. For additional information on NEI’s SBIR/STTR program, please refer to https://www.nei.nih.gov/grants-and-training/funding-opportunities/programs-and-research-priorities/small-business.

• The development of diagnostics, therapeutics, and disease prevention solutions for eye diseases and disorders exacerbated by climate change and other related environmental factors including toxin exposure, UV radiation, ozone depletion, and other related stress disorders affecting vision. NEI is particularly interested in supporting applications examining the impact of climate change and related environmental factors on dry eye disease, refractive error, photokeratitis, cataract onset and progression, and vector-borne diseases. Applications developing technologies, apps, or tools to enable effective delivery of eye health services impacted by climate events are also requested.

NIA

The mission of the National Institute on Aging (NIA) is to support and conduct genetic, biological, clinical, behavioral, social, and economic research on aging, foster the development of research and clinician scientists in aging, provide research resources, and disseminate information about aging and advances in research to the public, health care professionals, and the scientific community, among a variety of audiences. https://www.nia.nih.gov/research/sbir

• Technology that mitigates the impacts of climate change and extreme weather on health and/or well-being, pace of aging, and aging-related physiological processes (e.g., immune function, circadian rhythm, etc.) across the life span.
• Technology that measures interactions or additive effects on rates of aging due to environmental exposures or changing environmental hazards (e.g., particulates endocrine disrupters, residuals from manufacturing or other toxins, or extreme weather) on molecular, cellular, and physiological perturbations that impact health and/or well-being across the lifespan.
• Technology that measures interactions or additive effects of environmental exposures or changing environmental hazards (e.g., heightened amounts of air pollutants, extreme heat or cold) on affective, social, and cognitive functions over the life course, as well as effects on brain health across the lifespan.
• Tools, devices, or technological applications to support midlife and older adult health promotion, adaptation, and resilience in the face of climate change and in the aftermath of extreme weather events.
• Digital health tools to support functional abilities in midlife and older adult populations (e.g., day-to-day activities, physical limitations, sensory deficits, etc.) in the context of climate change or extreme weather conditions.
• Technology that mitigates the impact of age-related change in affective, social, and cognitive factors on individual responses to climate change, and on how individuals initiate and maintain the behavior changes needed for preparedness and adaptation to extreme weather events.
• Health services delivery technology and digital healthcare infrastructure preparedness in the context of climate change and extreme weather events.
• Technology that facilitates reducing healthcare facilities and systems contribution to climate change.
• Tools that develop, implement, and evaluate the effectiveness of communication or educational resources about health impacts of climate change for specific older adult populations or stakeholders, including individuals living with Alzheimer’s disease and related dementias and individuals and institutions that provide care for these individuals.

NIAID

The mission of the National Institute of Allergy and Infectious Diseases (NIAID) is to conduct and support basic and applied research to better understand, treat, and ultimately prevent infectious, immunologic, and allergic diseases. Our small business programs help bridge the gap between basic science and commercialization of new therapies, vaccines, diagnostic tests, and other technologies. Additional information can be found here: https://www.niaid.nih.gov/grants-contracts/small-businesses. Areas of interest include, but are not limited to:

• Novel tools and technologies to assess and quantitate, especially at the level of individual risk, the presence of aeroallergens likely to be affected by climate change.
• Novel tools and technologies to assess the impact of environmental and ecologic factors affected by climate change on the breeding, size, distribution, range and/or spread of populations of insect vectors of human disease or intermediate hosts of pathogens responsible for human disease.
• Novel or improved diagnostic tools and technologies suitable for population surveillance and monitoring for allergic and infectious diseases likely to change in incidence or prevalence due to climate change, and capable of yielding timely results for actionable risk mitigation.
• Tools and technologies to assess water safety at sites (environmental, recreational, or drinking waters) to prevent or reduce transmission of water-borne pathogens, such as Campylobacter jejuni, Cryptosporidium, Cyclospora, Entamoeba histolytica, diarrheagenic Escherichia coli, Giardia, Isospora, microsporidia, Naegleria, diarrhea-associated adenoviruses, rotavirus, caliciviruses, Salmonella, Shigella spp., and Vibrio spp., when extreme weather events (floods, heatwaves, and droughts) increase risk of human disease caused by these pathogens.
• Tools and technologies to assess enteric pathogen burden in wastewaters to develop strategies for management of infectious disease outbreaks.
• Diagnostics (simple, rapid, and point of care (POC) capable of detecting multiple enteric pathogens (e.g., Campylobacter jejuni, Cryptosporidium, enteropathogenic Escherichia coli, Giardia; diarrhea-associated adenoviruses, rotavirus, caliciviruses, Salmonella, Shigella spp., and Vibrio spp.) and associated antimicrobial resistance profiles directly from patient specimens (e.g., stool samples).
• Vaccines for primary prevention of diseases caused by food- and water-borne enteric bacterial and parasitic pathogens (e.g., Campylobacter species, Cryptosporidium, diarrheagenic Escherichia coli, Giardia, diarrhea-associated adenoviruses, rotavirus, caliciviruses, Salmonella, Shigella spp., and Vibrio spp.).

NICHD

The mission of the Eunice Kennedy Shriver National Institute of Child Health and Human Development (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. The NICHD's research portfolio includes research related to conception and pregnancy; typical and atypical development in childhood; childhood trauma and critical illness; the transition from adolescence to adulthood; reproductive health; rehabilitation; intellectual, developmental, and physical disabilities; and population dynamics across the lifespan.

• The development of tools and technologies to understand and address the consequences of climate-induced disasters for pregnant persons, children’s physical and mental health, and wellbeing.
• Development of tools, devices, and technological applications for reunification of children and families in climate-induced disaster events, taking into consideration age and developmental capabilities of children, and linguistic and cultural differences of families and communities.
• Development of tools, technologies, and applications to promote resilience, adaptation and coping in the context of climate change among NICHD priority populations

  , including pregnant women, children, and people with disabilities

  .

• Development of resources, measures, and strategies to identify vulnerable children and families most at risk for being adversely affected by climate change (e.g., homeless families, child welfare engaged families, children, and families in under-resourced rural, urban, tribal communities.

NIMH

The mission of the National Institute of Mental Health (NIMH) is to transform the understanding and treatment of mental illnesses through basic and clinical research, paving the way for prevention, recovery, and cure. NIMH fulfills its mission by: Supporting and conducting research on mental illnesses and the underlying basic science of the brain and behavior, https://www.nimh.nih.gov/funding/sbir.

• Development of technologies to enable effective delivery of mental health services to communities during extreme weather events as well as in response to climate change.
• Development of technologies to remotely assess mental health status and change in symptoms or clinical function for psychiatric indications, in communities affected by climate change.

NINR

The National Institute of Nursing Research (NINR) supports research that builds the scientific foundation for nursing practice and policy across clinical and community settings, and advances the prevention, detection, and management of disease and disability. Drawing on nursing’s holistic perspective, NINR funds research that integrates factors at multiple levels, including social determinants of health, to identify their role in health, health improvement, and health inequities. NINR promotes research that improves the health of individuals, families, and populations in a variety of settings, translating science in order to maximize the impact of findings on practice and policy. NINR is interested in a wide variety of digital health technologies.

• Digital health technologies that can be used to effectively deliver multi-level interventions in communities that experience socioeconomic, behavioral, and environmental vulnerabilities.
• Digital health technologies that would improve the implementation and dissemination of health protective strategies, especially in communities that experience socioeconomic, behavioral, and environmental vulnerabilities.

NIMHD

The mission of the National Institute on Minority Health and Health Disparities is to lead scientific research to improve minority health and reduce health disparities. To accomplish this, NIMHD plans, coordinates, reviews, and evaluates NIH minority health and health disparities research and activities; conducts and supports research in minority health and health disparities, promotes and supports the training of a diverse research workforce, translates and disseminates research information; and fosters innovative collaborations and partnerships. For information on NIHMD's SBIR/STTR program see Small Business Innovation/Tech Transfer (SBIR/STTR) (nih.gov)

• Tools and technology for predicting and improving access and resiliency to health care services for health disparity populations, including preparedness for natural and accidental disasters and public health emergencies.
• Diagnostics, tools, education, and treatments regarding the interplay of social determinants of health of the interactions or additive effects of combined chemical and non-chemical stressors.
• Tools, apps, education, and services that address health promotion and resilience in the aftermath of disaster events in populations affected by health disparities.
• Health services delivery and education regarding infrastructure, e.g., infrastructure readiness and general infrastructure issues that affect access to healthcare, food, clean water, safe and dry housing.
• Sustainable tools, services and interventional approaches to reduce disproportionate health burdens and build community resilience as a result of environmental changes and disasters (e.g., medical supplies, safe water, shelter, and food).

NCATS

The National Center for Advancing Translational Sciences (NCATS) strives to promote innovations that help mitigate bottlenecks in translational research pipeline that will ultimately result in better management of various human diseases. Global climate change is an unfolding crisis, and it is important to understand the effects it will have on human health. https://ncats.nih.gov/smallbusiness/resources

NCATS Will Not Support Clinical Trials With This NOSI.

• Data interoperability and predictive modeling for health and healthcare with respect to environmental change, public health emergencies or disasters.
• Validation and improved measurement of human health metrics, and subsequent impact(s) to health from climate change, with digital health technologies as well as other ambient sensing tools or methodologies.
• Technologies to shorten time of intervention adoption in the event of environmental changes or disasters.
• Technologies to reduce impact to clinical trials in the event of public health emergencies or disasters (e.g., decentralized clinical trial infrastructure, telemedicine).
• The dissemination and implementation of tools and technologies with respect to environmental change, public health emergencies or disasters to aid in the continuity of clinical research.
• Tools and technologies to train and scale up the healthcare workforce rapidly in the event of environmental change, public health emergencies or disasters.
• Novel approaches utilizing Microphysiological systems (MPS)/Tissue Chips and 3D bioprinting technologies to study and identify physiological changes/biomarkers associated with changes in the environment.

Additional Considerations

In developing technologies and approaches for research, applicants should consider cost, feasibility, and the potential end-users and markets for these technologies. Applicants should also clearly articulate how these technologies can be applied in real-world scenarios to address the impacts of climate change and the associated extreme weather events and to reduce the adverse effects of exposures (e.g., excessive heat, poor air quality, water contamination, chemicals, mold and other toxins, and psychosocial stress) on individuals or communities.

Applicants should provide clear, measurable (quantitative) milestones, particularly for Phase I applications and Phase I components of Fast-track applications.

NIH’s broad scientific expertise situates it in a unique position to tackle the complex set of factors that coalesce in the problem of climate change impacts on health. Applicants are strongly encouraged to contact program staff at the participating NIH Institutes and Centers prior to submitting an application.

Application and Submission Information

This notice applies to due dates on or after September 5, 2022 and subsequent receipt dates through April 5, 2023.

Submit applications for this initiative using one of the following funding opportunity announcements (FOAs) or any reissues of these announcement through the expiration date of this notice.

• PA-22-178 - PHS 2022-2 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Not Allowed)
• PA-22-179 - PHS 2022-2 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Required

All instructions in the SF424 (R&R) Application Guide and the funding opportunity announcement used for submission must be followed, with the following additions:

• For funding consideration, applicants must include "NOT-ES-22-009" in the Agency Routing Identifier field (box 4B) of the SF424 R&R form. Applications without this information in box 4B will not be considered for this initiative. Applicants must select the IC and associated FOA to use for submission of an application in response to the NOSI. The selection must align with the IC requirements listed in order to be considered responsive to that FOA. Non-responsive applications will be withdrawn from consideration for this initiative.

Although an NIH Institute is not listed as a Participating Organization in all the FOAs listed above, applications for this initiative will be accepted.

Applications nonresponsive to terms of this NOSI will not be considered for the NOSI initiative.

Inquiries

Scientific/Research Contact(s)

Daniel Shaughnessy, PhD
National Institute of Environmental Health Sciences (NIEHS)
Telephone: (984) 287-3321
Email: [email protected]

Stephanie Meyers Davis, PhD
National Heart, Lung, and Blood Institute (NHLBI)
Phone: (301) 496-8412
E-mail: [email protected]

Tony Douglas Gover, PhD
National Eye Institute (NEI)
Phone: 301-529-7370
E-mail: [email protected]

Saroj Regmi,PhD.
National Institute on Aging (NIA)
E-mail: [email protected]

Adriana Costero-Saint Denis, PhD
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-496-2544
E-mail: [email protected]

Regina Bures, PhD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-496-9485
Email: [email protected]

Adam Haim, PhD
National Institute of Mental Health (NIMH)
Telephone: 301-435-3593
Email: [email protected]

Kristopher Bough, PhD
National Institute of Nursing Research (NINR)
Phone: 301-496-2604
Email: [email protected]

LCDR Michael J. Banyas, MPA
National Institute on Minority Health and Health Disparities (NIMHD)
Phone: 301-402-1366
E-mail: [email protected]

Meena Uma Rajagopal, PhD
National Center for Advancing Translational Sciences (NCATS)
Phone: 3018271921
E-mail: [email protected]

Peer Review Contact(s)

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

Financial/Grants Management Contact(s)

Aaron Nicholas

National Institute of Environmental Health Sciences (NIEHS)
Telephone: 984-287-3297
Email: [email protected]

Annmarie Brasilemejac
National Heart, Lung, and Blood Institute (NHLBI)
Phone: (301) 827-8016
E-mail: [email protected]

Karen Robinsonsmith
National Eye Institute (NEI)
Phone: (301) 451-2020
E-mail: [email protected]

Jessi Perez
National Institute on Aging (NIA)
Phone: 301-496-1472
E-mail: [email protected]

Jason Lundgren
National Institute of Allergy and Infectious Diseases (NIAID)
Phone: 240-669-2973
Email: [email protected]

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

Tamara Kees
National Institute of Mental Health (NIMH)
Telephone: 301-443-8811
Email: [email protected]

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

Priscilla Grant, JD
National Institute on Minority Health and Health Disparities (NIMHD)
Phone: 301-594-8412
E-mail: [email protected]

Imoni M. Washington

Grants Management Specialist
National Center for Advancing Translational Sciences (NCATS), NIH, DHHS
Phone: 301-435-2939
E-mail: [email protected]