Notice of Special Interest (NOSI): Small Business Initiatives for Innovative Diagnostic Technology for Improving Outcomes for Maternal Health
Notice Number:
NOT-EB-21-001

Key Dates

Release Date:

February 22, 2021

First Available Due Date:
April 05, 2021
Expiration Date:
April 06, 2023

Related Announcements

NOT-EB-21-007 - Notice of Technical Assistance Webinar for Notice of Special Interest (NOSI): Small Business Initiatives for Innovative Diagnostic Technology for Improving Outcomes for Maternal Health

PA-20-265 - PHS-2020-2 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Not Allowed)

PA-20-261 - PHS 2020-2 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Required)

PA-20-260 – PHS 2020-2 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed)

PA-20-262 – PHS 2020-2 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Required)

PA-20-272 – Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)

NOT-AR-21-019 -Notice of NIAMS Participation in NOT-EB-21-001

Issued by

National Institute of Biomedical Imaging and Bioengineering (NIBIB)

National Heart, Lung, and Blood Institute (NHLBI)

National Human Genome Research Institute (NHGRI)

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 Neurological Disorders and Stroke (NINDS)

National Institute on Minority Health and Health Disparities (NIMHD)

National Center for Advancing Translational Sciences (NCATS)

National Institute of Arthritis and Musculoskeletal and Skin Diseases ( NIAMS )

Office of The Director, National Institutes of Health (OD)

All applications to this funding opportunity announcement should fall within the mission of the Institutes/Centers. The following NIH Offices may co-fund applications assigned to those Institutes/Centers.

Office of Research on Women's Health (ORWH)

Purpose

The purpose of this trans-NIH Notice of Special Interest (NOSI) is to inform potential applicants that the National Institute of Biomedical Imaging and Bioengineering and participating Institutes and Centers (ICs) invite SBIR/STTR applications to develop technologies or tools to quantitatively predict or indicate an increased risk for maternal morbidity and mortality (MMM).This NOSI is part of the Implementing a Maternal health and PRegnancy Outcomes Vision for Everyone (IMPROVE) initiative, which supports research to reduce preventable causes of maternal deaths and improve health for women before, during, and after delivery.

Key Dates

Application Due Date(s)

April 5, 2021, September 5, 2021, January 5, 2022, April 5, 2022, September 5, 2022, January 5, 2023, April 5, 2023, by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on these dates.

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.

Scientific Merit Review

July 2021, November 2021, March 2022, July 2022, November 2022, March 2023, and July 2023

Advisory Council Review

August 2021, February 2022, June 2022, August 2022, February 2023, June 2023, and August 2023

Earliest Start Date

December 2021, March 2022, July 2022, December 2022, March 2023, July 2023, and December 2023

Expiration Date

April 6, 2023

Background

Rising rates of maternal morbidity and mortality constitute a serious health crisis in the U.S., with an estimated 700 maternal deaths each year from conditions related to or associated with pregnancy or childbirth and over 50,000 women experiencing severe maternal morbidity (SMM).To prevent the occurrence or advancement of diseases associated with pregnancy and to improve the health of pregnant and postpartum women, early identification of those who are at risk for MMM is needed. This identification of risk could be done in clinical settings to inform treatment and prevention approaches and/or in-home settings using continuous monitoring to alert clinicians or patients about potential risks and encourage prevention and treatment steps in real time.

Over the past few years, significant advances have been made in the discovery of biomarker signatures to identify risk for MMM, including those for biological and behavioral states related to disease prevention and identification. Many of these advances have been made because of the development of new and improved imaging, genetic, mobile, and machine learning technologies. Additionally, the development of devices that can measure such biomarkers at the point of care (POC) or in wearable fashion have become common place.

It now appears feasible to develop clinical tools that can measure biomarkers or surrogate markers for MMM. Such an objective tool would allow for improved clinical MMM research, prevention, and treatment. Currently, there is an urgent need for personalized treatment options for pregnant women at risk for MMM. However, MMM research and diagnosis are hampered due to the lack of technology to measure these objective predictors of risk for MMM in a POC or wearable continuous monitoring fashion for early detection. Quality research and treatment require quantitative measurement; these tools could improve the prevention and treatment of MMM.

Research Objectives

This NOSI is intended to encourage interest in the small business community to develop various approaches, technologies, and tools to address the health issues of maternal morbidity and mortality by achieving a wide array of outcomes, such as 1) the identification, phenotyping, subtyping, and stratification of patients at a greater risk of MMM, 2) multi-level interventions to address racial disparities in MMM, and 3) clinical decision-making that considers social and cultural biases.

Furthermore, this NOSI focuses on the development and validation of tools, technologies, and approaches, including artificial intelligence (AI) and machine learning, that indicate states of increased risk for and presence of MMM. This includes but is not limited to development of tools and technologies that:

  1. Measure factors associated with increased risk for MMM, including but not limited to blood pressure, heart rate, maternal/fetal physiology, or pupil dilation and facial expression.
  1. Measure biometrics associated with the onset and exacerbation of various diseases of MMM, including but not limited to depression or preeclampsia.
  1. Predict risk from a variety of data sources, for example, medical charts and electronic health records.
  1. Alert patients and clinicians to potential risk factors.
  1. Suggest various prevention and treatment approaches.

Technologies that are affordable, scalable, and easy to implement within a variety of clinical settings, including primary care, will maximize the benefit to the patient population. Moreover, technologies that take social and cultural norms into the design consideration to maximize adoption by the patient population are of critical importance. These devices could be used at the point of care or in-home settings, where these devices could be worn by pre- and post-partum women and/or health-care providers when there is increasing risk. Due to the many recent advances in monitoring devices to predict health conditions by measuring behavioral and biomarkers, this NOSI is particularly interested in the development of new technologies that can combine different behavioral and biomarker measurements.

National Human Genome Research Institute (NHGRI)

NHGRI supports the development of resources, approaches, and technologies that accelerate and support studies focused on the structure and biology of genomes; the genomics of disease; the implementation and effectiveness of genomic medicine; genomic data science and bioinformatics; training, developing, and expanding the diversity of the genomics workforce; and ethical, legal, and social issues related to genomic advances. More details about the institute’s vision and priority areas can be found in the 2020 NHGRI Strategic Vision (https://www.genome.gov/2020SV).

Examples of research relevant to NHGRI’s mission include, but are not limited?to,?the following:?

  • Systems for clinical decision support that integrate genetic testing in clinical care to prevent onset of MMM.??
  • Integration of diverse data types, such as family history, other omics data, environmental data or standard protocols (e.g.?PhenXToolkit) to improve the utility of genomic information for women who are at risk of MMM.?
  • Applications of machinelearning (ML) and artificial intelligence (AI) from electronic health records to identify biomarkers for the presence or risk of developing maternal mortality disease phenotypes.?
  • Methods and systems to lower barriers for access to genetic testing for underrepresented populations.?
  • Advancing genomic technologies that have broad applicability for the unique aspects and challenges of samples containing maternal-fetal biomaterial mixtures. (Advancing Genomic Technology Development for Research and Clinical Application)

Activity Code

FOA

First Available Due Date

R41, R42

PA-20-265- PHS-2020-2 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Not Allowed)

April 5, 2021

R41, R42

PA-20-261- PHS 2020-2 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Required)

April 5, 2021

R43, R44

PA-20-260– PHS 2020-2 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed)

April 5, 2021

R43, R44

PA-20-262– PHS 2020-2 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Required)

April 5, 2021

R41, R42, R43, R44

PA-20-272– Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)

Due dates may vary by awarding IC. See the awarding IC's web site. Applicants may also contact their respective awarding IC.

The National Institute of Biomedical Imaging and Bioengineering (NIBIB)

NIBIB is interested in projects focused on the development, engineering and design of technologies that can monitor pre- and post-partum women for MMM factors.

Examples of research of interest to NIBIB include, but are not limited to:

  • Advanced AI algorithms, modeling, and simulation technologies
  • Point-of care technologies for the clinical or hospital setting
  • Clinical decision support technologies
  • Wearable technologies for continuous monitoring

A complete list of programmatic interests in NIBIB can be found at:https://www.nibib.nih.gov/research-funding.

Activity Code

FOA

First Available Due Date

R41, R42

PA-20-265- PHS-2020-2 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Not Allowed)

April 5, 2021

R41, R42

PA-20-261- PHS 2020-2 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Required)

April 5, 2021

R43, R44

PA-20-260– PHS 2020-2 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed)

April 5, 2021

R43, R44

PA-20-262– PHS 2020-2 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Required)

April 5, 2021

R41, R42, R43, R44

PA-20-272– Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)

Due dates may vary by awarding IC. See the awarding IC's web site. Applicants may also contact their respective awarding IC.

NOTE: For projects submitted to NIBIB proposing clinical trials, note that NIBIB will only support 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. This guidance applies to applications submitted using funding opportunity announcements (FOAs) listed in the “Application and Submission Information” section, and their subsequent reissuances. Under these announcements, 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.

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

NICHD is interested in projects focused on detecting, predicting, and/or monitoring conditions or disorders during pregnancy and/or the post-partum period that contribute to MMM. Examples of peri- and postpartum disorders and conditions of interests include, but are not limited to:

  • Hypertensive disorders of pregnancy, including gestational hypertension, pre-eclampsia, and eclampsia
  • Gestational diabetes
  • Obstetric hemorrhage
  • Peripartum infection

In addition to the above pregnancy-related or pregnancy-induced disorders, NICHD is also interested in projects that enhance the monitoring and management of women who enter pregnancy with existing medical conditions and risk factors for adverse pregnancy-related outcomes. Moreover, NICHD is interested in projects that include disadvantaged and underserved racial and ethnic populations, as well as populations with intellectual, developmental, and physical disabilities. The current NICHD Strategic Plan can be found at: https://www.nichd.nih.gov/about/org/strategicplan

NOTE: For applications submitted to this, NICHD will support those that propose clinical trials.

Activity Code

FOA

First Available Due Date

R41, R42

PA-20-265- PHS-2020-2 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Not Allowed)

April 5, 2021

R41, R42

PA-20-261- PHS 2020-2 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Required)

April 5, 2021

R43, R44

PA-20-260– PHS 2020-2 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed)

April 5, 2021

R43, R44

PA-20-262– PHS 2020-2 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Required)

April 5, 2021

R41, R42, R43, R44

PA-20-272– Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)

Due dates may vary by awarding IC. See the awarding IC's web site. Applicants may also contact their respective awarding IC.

National Heart, Lung, and Blood Institute (NHLBI)

NHLBI is interested in projects focused on detecting, predicting, and/or monitoring heart, lung, blood, and sleep-related (HLBS) disorders during pregnancy and/or the post-partum period. Examples of peri- and postpartum disorders and conditions of interest to NHLBI include, but are not limited to:

  • Hypertensive disorders of pregnancy, including chronic hypertension, gestational hypertension, pre-eclampsia, and eclampsia
  • Postpartum cardiomyopathy
  • Venous thromboembolism
  • Postpartum hemorrhage
  • Sleep disordered breathing in pregnancy

In addition to the above pregnancy-related or pregnancy-induced disorders, the NHLBI is also interested in projects that enhance the monitoring and management of women with existing HLBS-specific disorders and risk factors who enter pregnancy or are considering becoming pregnant. Technologies that take social and cultural norms into design consideration to maximize their adoption are also encouraged. NHLBI also encourages dissemination and implementation projects that address barriers to uptake of evidence-based practices for HLBS conditions and disorders. A complete list of scientific focus areas in the NHLBI can be found at: https://www.nhlbi.nih.gov/science.

Activity Code

FOA

First Available Due Date

R41, R42

PA-20-265- PHS-2020-2 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Not Allowed)

April 5, 2021

R41, R42

PA-20-261- PHS 2020-2 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Required)

April 5, 2021

R43, R44

PA-20-260– PHS 2020-2 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed)

April 5, 2021

R43, R44

PA-20-262– PHS 2020-2 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Required)

April 5, 2021

R41, R42, R43, R44

PA-20-272– Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)

Due dates may vary by awarding IC. See the awarding IC's web site. Applicants may also contact their respective awarding IC.

National Institute of Mental Health (NIMH)

NIMH’s mission is to transform the understanding and treatment of mental illnesses through basic and clinical research, paving the way for prevention, recovery, and cure. For this NOSI, NIMH is interested in supporting the development of technologies that can predict, detect, monitor, prevent, and/or treat perinatal depression and associated psychiatric morbidity (e.g., bipolar disorder, perinatal psychosis, self-harm and suicide attempts) in individual patients and can alert patients and clinicians in near-real time.

Examples of research of interest to NIMH include, but are not limited to:

  • Development of algorithms that leverage passive mHealth data to predict, detect and monitor symptoms associated with perinatal depression and associated psychiatric morbidity (e.g., bipolar disorder, perinatal psychosis, self-harm, and suicide attempts).
  • Testing of wearable technology to accurately monitor symptoms.
  • Development and testing of real time remote clinical decision support technology.
  • Development of technology that incorporates established prevention and treatment approaches into just in time adaptive interventions to prevent and treat perinatal depression and associated psychiatric morbidity (e.g., bipolar disorder, perinatal psychosis, self-harm and suicide attempts).

Applications submitted to NIMH that involve a clinical trial (CT) should comport with NIMH CT expectations, including utilization of an experimental therapeutics approach for the development and testing of therapeutic, preventive, and services interventions. For more information on mechanistic, treatment, prevention or services CTs at NIMH see: https://www.nimh.nih.gov/funding/opportunities-announcements/clinical-trials-foas/index.shtml. Prospective applicants are strongly encouraged to contact NIMH prior to submission.

Activity Code

FOA

First Available Due Date

R41, R42

PA-20-265- PHS-2020-2 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Not Allowed)

April 5, 2021

R41, R42

PA-20-261- PHS 2020-2 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Required)

April 5, 2021

R43, R44

PA-20-260– PHS 2020-2 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed)

April 5, 2021

R43, R44

PA-20-262– PHS 2020-2 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Required)

April 5, 2021

R41, R42, R43, R44

PA-20-272– Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)

Due dates may vary by awarding IC. See the awarding IC's web site. Applicants may also contact their respective awarding IC.

National Center for Advancing Translational Sciences (NCATS)

NCATS is interested in projects focused on bioinformatics and clinical research management tools and technologies that address pre- and post-partum factors related to MMM.

Examples of research of interest to NCATS include, but are not limited to:

  • Pre-clinical drug discovery and development tools
  • Biomedical, Clinical & Health Research Informatics
  • Clinical Research Management tools

A complete list of programmatic interests can be found at:https://ncats.nih.gov/smallbusiness/priorities

NOTE: For applications submitted to this NOSI that propose clinical trials, NCATS does not support applications proposing any clinical trials in the submitted application. Applicants are encouraged to contact NCATS staff at NCATS-SBIRSTTR@mail.nih.gov prior to submitting their application in order to ensure it is aligned with NCATS’s SBIR/STTR research interests.

Activity Code

FOA

First Available Due Date

R41, R42

PA-20-265- PHS-2020-2 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Not Allowed)

April 5, 2021

R41, R42

PA-20-261- PHS 2020-2 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Required)

April 5, 2021

R43, R44

PA-20-260– PHS 2020-2 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed)

April 5, 2021

R43, R44

PA-20-262– PHS 2020-2 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Required)

April 5, 2021

R41, R42, R43, R44

PA-20-272– Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)

Due dates may vary by awarding IC. See the awarding IC's web site. Applicants may also contact their respective awarding IC.

National Institute of Neurological Disorders and Stroke (NINDS)

The mission of NINDS is to reduce the burden of neurological disease—a burden borne by every age group, by every segment of society, by people all over the world (https://www.ninds.nih.gov/About-NINDS/Who-We-Are/Mission). To this end, the Institute supports and conducts research on the healthy and diseased brain, spinal cord, and peripheral nerves. For this NOSI, NINDS is interested in the development of technologies that address maternal morbidity and mortality (MMM) within the scope of the NINDS mission space. Potential NINDS areas of interest related to maternal mortality and morbidity include stroke, cerebral venous thrombosis (CVT), migraine, peripheral neuropathies, chorea, and posterior reversible encephalopathy syndrome (PRES).

NOTE: NINDS does not support applications to the omnibus clinical trial PAR-20-261 or PAR-20-262. Small Business concerns proposing clinical trials under the NINDS mission space should consider applying directly to PAR-18-617: NINDS Exploratory Clinical Trials for Small Business (R42), or PAR-18-618 NINDS Exploratory Clinical Trials for Small Business (R44). In addition, applicants are encouraged to consider Small Business U44 Cooperative Agreement mechanisms under the NINDS Translational Neural Devices program https://www.ninds.nih.gov/Current-Research/Research-Funded-NINDS/Translational-Research/Funding-Programs-Researchers/Translational-Devices.

Activity Code

FOA

First Available Due Date

R41, R42

PA-20-265- PHS-2020-2 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Not Allowed)

April 5, 2021

R42

PAR-18-617- NINDS Exploratory Clinical Trials for Small Business (R42 Clinical Trial Required)

April 5, 2021

R43, R44

PA-20-260– PHS 2020-2 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed)

April 5, 2021

R44

PAR-18-618- NINDS Exploratory Clinical Trials for Small Business (R44 Clinical Trial Required)

April 5, 2021

R41, R42, R43, R44

PA-20-272– Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)

Due dates may vary by awarding IC. See the awarding IC's web site. Applicants may also contact their respective awarding IC.

National Institute on Minority Health and Health Disparities (NIMHD)

NIMHD has an ongoing interest in technological innovations to improve health and to reduce, eliminate or prevent disparities in maternal mortality and morbidity experienced by racial and ethnic minority women compared to white women. When developing new technologies, including artificial intelligence and machine learning, the diverse voices of underserved women need to be included to mitigate unintended consequences and prevent exacerbation of disparities. The health of racial and ethnic minority women and the excess burden of maternal mortality and morbidity experienced result from factors operating within and across multiple domains (e.g., biological, behavioral, socio-cultural, environmental, physical environment, healthcare system) and multiple levels (e.g., individual, interpersonal, community, societal) (see the NIMHD Research Framework).

Projects leading to commercially available, affordable, accessible and culturally acceptable technologies disrupting or preventing the interactions and processes responsible for or implicated in the creating, promoting or sustaining these and associated disparities are encouraged. Projects examining social determinants of health and informed by the NIMHD Research Framework are encouraged. Projects that leverage the capabilities of design thinking or similar systems or societal level thinking are encouraged. Projects employing teams with expertise across two or more domains are also encouraged.

Examples of potential topic areas include but are not limited to:

  1. Innovative technologies for identifying racial and ethnic minority women at high risk for pregnancy complications, with American Indian/ Alaska Native and African American women being a priority
  2. Patient-centered technologies for identifying and leveraging racial and ethnic specific sociocultural protective factors and areas of resiliency (e.g., community support)
  3. Disruptive technologies leveraging multiple digital technologies, for example, Fast Healthcare Interoperability Resources, PhenX Toolkit, personalized medicine, and electronic health records for preventing mortality and morbidity disparities
  4. Technology with high success in predicting health care delivery and care strategies for disrupting health disparities outcomes and for racial and ethnic women at high risk for adverse health care delivery outcomes
  5. Technologies disrupting or preventing the impact of discrimination, bias, indifference, on maternal mortality and morbidity outcomes for high risk racial and ethnic women across systems of care and levels of influence (interpersonal, system, and structural)
  6. Technology leading to decision aids for risk assessment (especially to promptly identify onset of chronic diseases or complications during the first year postpartum) and utilizing evidence from multiple levels and domains, including life course, family history, health care systems, and organizational data
  7. Technology interventions that address the role of low levels of health literacy and Limited English Proficiency in underserved minority populations in shared decision-making and informed choice
  8. Technologies for strategic multilevel and multidomain risk assessment and monitoring and integrating patient, provider, life course, clinical, organizational, community, and societal level data for predicting maternal mortality and morbidity risk and preventive interventions, especially during the first year postpartum and beyond
  9. Technology leading to equal access, effective continuity of care, and provision of quality care through disruption of the limitations resulting from factors like insurance coverage, socioeconomic status, access to community resources, and site of care
  10. Technology for eliminating the severe morbidity experienced by racial and ethnic minority women resulting from pregnancy-related complications (e.g., hemorrhage, sepsis, eclampsia, cardiovascular events) To be effective this technology must also consider the higher prevalence of chronic conditions (e.g., hypertension, obesity, cardiovascular disease) that may exacerbate maternal morbidity among women from racial and ethnic minority groups, especially African American, American Indian/Alaska Native and Hispanic/Latinas
  11. Technology exploiting protective factors to decrease rates of maternal morbidity and maternal mortality across SES levels for women from racial and ethnic minority backgrounds
  12. Technology for improvements in quality of obstetric care (including pre-natal, perinatal, and post-natal care) that eliminate racial disparities in maternal outcome

Activity Code

FOA

First Available Due Date

R41, R42

PA-20-265- PHS-2020-2 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Not Allowed)

April 5, 2021

R41, R42

PA-20-261- PHS 2020-2 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Required)

April 5, 2021

R43, R44

PA-20-260– PHS 2020-2 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed)

April 5, 2021

R43, R44

PA-20-262– PHS 2020-2 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Required)

April 5, 2021

R41, R42, R43, R44

PA-20-272– Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)

Due dates may vary by awarding IC. See the awarding IC's web site. Applicants may also contact their respective awarding IC.

National Institute of Allergy and Infectious Diseases (NIAID)

NIAID supports basic and translational research to better understand, diagnose, prevent, and treat, infectious and immune-mediated diseases, including diseases that impact the health of women and girls. NIAID is interested in small business technological innovations that address maternal morbidity and mortality within the scope of the NIAID mission. Examples include, but are not limited to:

  • The development of technologies that detect and monitor normal dynamics of the maternal immune system during pregnancy as well as identifying clinically-relevant immune dysfunction metrics for the prediction of pregnancy complications (e.g. infections, preeclampsia, sepsis) that lead to maternal morbidity and mortality.
  • The development of technologies that detect characteristic immune parameters prior to clinical onset of pregnancy complications with the ability to notify the clinical provider for subsequent intervention.
  • Development of diagnostics for parasitic diseases, notably but not exclusively malaria, that adversely impact maternal health and pregnancy outcomes, and demonstration of performance characteristics.
  • Development of an assay that has the capability to rapidly detect T. pallidum from clinical specimens, including the sample preparation methods, and demonstrate the performance characteristics of the assay.
  • Development and validation of diagnostics for gestational Lyme disease, which can adversely impact maternal health and pregnancy outcome

Activity Code

FOA

First Available Due Date

R41, R42

PA-20-265- PHS-2020-2 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Not Allowed)

April 5, 2021

R41, R42

PA-20-261- PHS 2020-2 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Required)

April 5, 2021

R43, R44

PA-20-260– PHS 2020-2 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed)

April 5, 2021

R43, R44

PA-20-262– PHS 2020-2 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Required)

April 5, 2021

R41, R42, R43, R44

PA-20-272– Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)

Due dates may vary by awarding IC. See the awarding IC's web site. Applicants may also contact their respective awarding IC.

Office of Research on Women’s Health (ORWH)

ORWH focuses on research that is relevant to the health of women and is interested in small business innovations that intersect with the goals, objectives, and guiding principles of the trans-NIH Strategic Plan for Women’s Health Research (https://orwh.od.nih.gov/about/trans-nih-strategic-plan-womens-health-research) and maternal health. Specific examples include, but are not limited to the development of technologies that can improve maternal health in:

  • Understudied, underrepresented, and underreported women such as racial and ethnic minority populations of women or women residing in rural or underserved areas.
  • Women with complex health needs such as the co-occurrence of cardiovascular disease, diabetes, or obesity, along with co-morbid conditions. 
  • Women experiencing homelessness or living in overcrowded congregate housing, or women incarcerated or under community supervision.
  • By identifying risks factors relate to the social determinants of maternal health (i.e. low socioeconomic status, access to care, food security)
  • Health by determining risk factors related to the intersectional dimensions of pregnant women such as race, age, geolocation.

Application and Submission Information

This notice applies to due dates on or after April 5, 2021 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 NOSI.

  • PA-20-265- PHS-2020-2 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Not Allowed) 

  • PA-20-261- PHS 2020-2 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Required) 

  • PA-20-260- PHS 2020 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications ([R43/R44] Clinical Trial Not Allowed) 

  • PA-20-262 – PHS 2020-2 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Required) 

  • PA-20-272– Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional) Applications for this administrative supplement will only be accepted for R41, R42, R43, R44 grant mechanisms.

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-EB-21-001 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 planning to apply in response to this NOSI are strongly encouraged to contact and discuss their proposed research/aims with an NIH Program Officer listed on this NOSI well in advance of the application due date.

 

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

Inquiries

Please direct all inquiries to the contacts in Section VII of the listed funding opportunity announcements with the following additions/substitutions:

 

Scientific/Research Contacts

Ilana Goldberg, Ph.D.
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Telephone: 301-402-3465
Email:ilana.goldberg@nih.gov

Jamie White, M.S.
Office Of Research On Women's Health (ORWH)
Phone:301-402-1770
E-mail: jamie.white@nih.gov

Andrew A. Bremer, M.D., Ph.D.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD
Telephone: 301-402-7886
Email:andrew.bremer@nih.gov

Adam J. Haim, Ph.D.
Division of Services and Intervention Research
National Institute of Mental Health (NIMH)
Phone: (301) 435-3593
Email: haima@mail.nih.gov

Jyoti Dayal, M.S.
National Human Genome Research Institute (NHGRI)
Telephone: 301-480-2307
Email: jyotig@nih.gov

Emily Caporello, Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)
Phone: 301-496-1779
Email: Emily.caporello@nih.gov

Jasmina Varagic, M.D., Ph.D.
National Heart, Lung, and Blood Institute (NHLBI)
Phone: 301-827-5569
Email: jasmina.varagic@nih.gov

Lili Portilla, MPA
National Center for Advancing Translational Sciences (NCATS)
Telephone: 301-827-7170
Email:lilip@nih.gov

Soju Chang, MD, MPH
National Center for Advancing Translational Sciences (NCATS)
Telephone: (301) 827-9206
E-mail: soju.chang@nih.hhs.gov

Deborah Linares
National Institute on Minority and Health and Health Disparities (NIMHD)
Telephone: (301) 402-2516
Email: deborah.linares@nih.gov

Mercy R Prabhudas
National Institute of Allergy and Infectious Diseases (NIAID)
Phone: 240-627-3534
E-mail: mprabhudas@niaid.nih.gov

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)

James Huff
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Telephone: 301-451-4786
Email: james.huff@nih.gov

Monika Christman
National Human Genome Research Institute (NHGRI)
Phone: 301-435-7860

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

Jason A Lundgren
National Institute of Allergy and Infectious Diseases (NIAID)
Phone: 240-669-2973
E-mail:lundgrenj@mail.nih.gov

Melani Ledu
Eunice Kennedy Shriver National Institute Of Child Health & Human Development (NICHD)
Phone: 301-402-4165
E-mail: melani.ledu@nih.gov

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

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

Chief Grants Management Officer
National Institute of Neurological Disorders and Stroke (NINDS)
Email:ChiefGrantsManagementOfficer@ninds.nih.gov


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices