Grants for State governments - Environment

This funding opportunity supports innovative research projects on brain and nervous system disorders, encouraging collaboration between scientists in the U.S. or upper-middle-income countries and those in low- and middle-income countries to improve health outcomes throughout life.

This funding opportunity supports collaborative research projects aimed at addressing brain and nervous system disorders in low- and middle-income countries, focusing on building sustainable research capacity and improving neuro-health outcomes.

This funding opportunity is designed to support small-scale research projects at health professional and graduate schools that have limited NIH funding, helping to enhance research capabilities and engage students in meaningful research experiences.

The purpose of this Funding Opportunity Announcement (FOA) is to support research that will advance the measurement and assessment of complex constructs relevant to minority health and health disparities.Research Objectives This initiative will support research to improve the measures and methods for complex social constructs that capture the lived experience of populations that experience health disparities. The NIH-designated U.S. populations with health disparities are racial and ethnic minority groups, sexual and gender minority groups, underserved rural populations, and socioeconomically disadvantaged populations of any race or ethnicity (https://www.nimhd.nih.gov/about/overview/). The objective of this initiative is to produce knowledge that can inform the field about the types of measurement approaches that may be most suitable for different health disparities-related research questions or specific populations, settings, or contexts. Projects are expected to examine the performance and utility of specific measurement and/or methodological approaches. Projects that simply use new or existing measures or methods to answer health disparities-related research questions, without examining their performance or utility, are not responsive to this FOA. Projects are encouraged to use multiple data sources across different levels and across multiple sectors when appropriate. However, because this initiative emphasizes capturing the lived experiences of individuals and populations, all projects are expected to include self-report measures or data in some way. Projects should also include relevant diversity (e.g., with respect to age, gender, race/ethnicity, socioeconomic status, sexual or gender minority status, and/or geographic region) in sampling, enrollment, and data analysis needed to advance health disparities and health equity research and interventions development. Examples of potential study designs include but are not limited to the following: Testing the validity and reliability of one or more new or existing measures within a single project. Developing and validating new measures of complex social constructs (e.g., structural racism) that are associated with health disparities and health inequities. Examination of psychometric properties and/or patterns of findings with different measures of the same construct across existing studies or datasets. Mixed-methods approaches including the integration of qualitative and quantitative data (e.g., research in which qualitative interviews or focus groups inform the development of quantitative measures) in which participants complete quantitative measures and provide their perspectives on the measures via cognitive interviews, or other qualitative strategies. Examination of measurement of cultural or construct equivalence or invariance across populations with health disparities and subpopulations within these groups such as recent immigrants or persons with disabilities. Examination of utility and feasibility of incorporating novel data sources to assess higher-level determinants of health and health disparities such as structural racism. Examination of ethical issues related to different measurement or analytic strategies, including understanding and mitigating potential risk from individual or group harm from data collection, analysis or dissemination. Examination of alternative methods for collecting data for these measures. Examination of novel analytic methods for exploring the interacting influences of factors associated with health disparities that are measured at different levels, across time, and/or across settings. Areas of Research Interest NATIONAL EYE INSTITUTE The mission of the National Eye Institute (www.nei.nih.gov) is to eliminate vision loss and improve quality of life through vision research. The NEI supports basic and clinical research into diseases and disorders of the visual system and the special needs of people with impaired vision or who are blind. The NEI encourages innovative applications that will advance innovative development of new measures and methods, or testing and adaptation of existing measures and approaches, to address health disparities and health inequities in the prevention, diagnosis, treatment and management of eye and vision conditions. NIMHD’s interests include, but are not limited to, the following: The lived experience of intersectionality, including self-identification, group affiliation, and multidimensional aspects of race and ethnicity as well as intersectional bias, stigma, and discrimination. Composite and cumulative exposure to adversity, including measures that encompass critical developmental periods, magnitude/frequency of exposure over time, and exposure and resilience across multiple levels and life stages. Measurement of protective and resilience factors, at both the individual (e.g., personality traits, psychological resources, behavioral skills) and sociocultureal levels (e.g., interpersonal, community, societal). The relationship between individual and higher-level determinants, including how neighborhood, community, and societal level determinants are associated with individual-level experiences, and in what circumstances higher-level social determinants can and cannot serve as proxies for individual-level determinants and vice versa. Advancing place-based indexes, composite measures and geocoded analysis, including best practices for clustering community and social level factors, level of granularity/area for specific purposes, ability to predict and explain health or health care disparities. Of interest are the extent to which these measures are predictive, and their usefulness in determining how structural racism and discrimination within regional or location specific conditions limit opportunities, resources, and power. Measurement of structural racism and discrimination, such as the facets, magnitude and cumulative effects of inequities in power, access, opportunities, treatment, and policy embedded in structures, institutions, and communities that contribute to inequities in health outcomes. Analytic methods to enable better understanding of the causes of health disparities, including identification of the causal pathways that connect the etiology (i.e., health determinants) with the effect (i.e., health disparities), especially with limited longitudinal data available. Advance analytic methods of small populations and population subgroups, including methods to analyze and interpret studies with large differences in population sample sizes (e.g., 100 vs 10,000). Methods are also needed to identify unique characteristics of population subgroups and within group heterogeneity. Development of culturally appropriate, unbiased health risk factors and outcome measures that are predictive across populations or tailored for populations. Testing and evaluation of accepted behavioral constructs in diverse populations to understand the science of behavior change in these groups. For example, measurement of behavioral intent is generally accepted as having a higher likelihood of actually doing this behavior although evidence in diverse communities is limited. National Cancer Institute The National Cancer Institute seeks applications that advance innovative development of new measures and methods, or testing and adaptation of existing measures and approaches, to address health disparities and health inequities in cancer prevention and control and survivorship. Applications of interest may include: Development, testing or adaptation of organizational, health system, and policy measures of structural racism, discrimination and SDOH. Advancement of measures and methods that facilitate development and testing of theories, models and frameworks that identify mechanisms by which Structural Racism influences cancer prevention and control outcomes at individual, interpersonal, healthcare, organizational and community levels. Advancement of methods and measures that facilitate development and testing of theories, models, and frameworks to identify when SDOH operate as moderators to multilevel or policy interventions and when a SDOH are/should be a target for interventions to reduce cancer health disparities. Approaches may consider the reinforcing and multi-sectoral influences of SDOH that may reinforce inequalities. Research to advance real-time/rapid assessment of SDOH measures and social risks that influence health behavior (e.g., diet, physical activity, sleep & alcohol) in multilevel interventions to reduce cancer health disparities and improve health equity. Research to develop, test, and validate measures to assess social determinants of health and other social factors (e.g., culture, power, trust, stigma, discrimination, intersectional identity) associated with cancer prevention and control outcomes using robust statistical approaches, such as exploratory factor analysis, confirmatory factor analysis, structural equation modeling, and analyses to assess within-group effects. Research to develop and validate pragmatic and actionable measures to identify or influence modifiable individual, social, community, or system factors that can reduce health inequities. Projects may include research to define and measure geographic units for area-based SDOH in diverse populations to improve cancer prevention and control. Research to validate new or existing measures of constructs associated with cancer health disparities (such as SDOH, social risk, community assets, culture, wealth, literacy). Approaches should include (but are not limited to) content, construct, convergent and discriminant reliability across and within populations experiencing disparities. Research to support the development of methods and measures that examine intersecting influences of healthcare access such as treatment costs, insurance coverage and out of pocket costs, geographic proximity to clinics, value of care, access to telehealth (e.g., technology and broadband access), and social topics such as clinician implicit bias. Integration of qualitative and quantitative research methods, in which qualitative methods are used to identify novel and emerging social and structural constructs contributing to health/ health disparities, and such knowledge is used to inform the development and validation of quantitative instruments to assess those constructs Apply stakeholder engaged approaches to identify and develop measures that are based on the interests and primary concerns identified by multiple groups, such as patients, providers, organizations, and communities, particularly for communities that are under resourced and small populations that have historically not been included in research or with whom measures have not been developed or validated in cancer prevention and control. Development of methods to examine individual and co-occurring factors associated with health inequities, such as demographic characteristics of patients and providers, geography, socioeconomic factors, and social constructs including implicit bias, overt and covert racism. Applications that advance the understanding of sleep disparities and how they affect cancer risk and/or cancer survivorship in underserved and marginalized populations, by developing or validating multidimensional sleep metrics, developing measures of cumulative sleep exposure , and integrating individual-level sleep metrics into a multilevel approach incorporating measurements of light, noise, and other personal, neighborhood or environmental intrapersonal and interpersonal influences on sleep behavior. National Institute of Environmental Health Sciences The mission of the National Institute of Environmental Health Sciences (NIEHS) is to discover how the environment affects people to promote healthier lives. The NIEHS seeks applications that advance innovative development of new measures and methods, or validation and adaptation of existing measures and approaches, to address the complex interplay of the physical, chemical, cultural, social, and built environmental factors that contribute to or exacerbate environmental health disparities. Applications of interest may include, but are not limited to: The use of mixed methods approaches that integrate qualitative and quantitative data collection methods and measures of factors that contribute to environmental health disparities, including how qualitative methods can inform the development and validation of quantitative surveys and instruments that evaluate these factors. Application and testing of methods and measures of SDOH, and structural racism and discrimination, to the study of environmental health disparities. Establishment of novel interdisciplinary collaborations (including, but not limited to, methodologists, behavioral scientists, exposure scientists, epidemiologists, bioinformaticians, biostatisticians, data scientists, social scientists) to incorporate concomitant chemical and built environmental factors with existing or developed measures of structural and individual racism into a multilevel assessment of environmental health disparities. Development, testing and adaptation of methods and measures that capture the lived experience of intersectionality to identify structural factors contributing to disproportionate exposures to chemical and non-chemical stressors at the community and individual level. Application of community engaged approaches to identify or develop measures that are based on the interests and primary concerns identified by multiple community stakeholders, such as parents, schools, organizations, and fence-line residents, particularly for communities that are under resourced and populations that have historically been combating environmental injustices and disparate rates of adverse health outcomes. Examination of the ethical issues related to methods and measurement approaches in the study of environmental health disparities, including issues around data harmonization and the collection of common data elements. Enhancement of existing place-based indices, environmental exposures models and geocoded data to account for social level factors, to explain environmental health disparities at the regional or community level. Of interest are the extent to which these measures demonstrate how placed-based structural racism and discrimination exacerbate environmental risk factors and/or limit protective factors. Novel use of SDOH and structural racism and discrimination methods and measures to guide the development of multi-level, evidence-based prevention and intervention strategies to reduce environmental health disparities. National Institute of Dental and Craniofacial Research NIDCR is interested in funding research that will advance measurement, analysis, and monitoring of social determinants of health that contribute to dental, oral, and craniofacial (DOC) health disparities and inequities within the U.S. population over time and across settings. To this end, NIDCR will support research to examine the performance and utility of measures and methodologic approaches to improve the measurement and assessment of social determinants of DOC health. Specific areas of research interest include but are not limited to: Examining approaches to measure, analyze, and/or monitor social and structural determinants of health affecting DOC health disparities and inequities in a population or across populations Elucidating intersectionality of social determinants of DOC health and their independent and synergistic effect on DOC health disparities and inequities within- and between-groups Examining methodologic approaches to analyze protective and resilience factors relating to DOC health disparities and inequities across a population and/or between subpopulations Examining the performance of measures to identify structural racism and discrimination and the impact on DOC health disparities and inequities among racial and ethnic minorities during the life-course Assessing the utility of geographic and area indices and analytical methodologies that inform DOC health care needs and the performance of DOC health systems in rural communities Assessing the utility and feasibility of using electronic health record (EHR) data to monitor DOC health disparities and inequities over time and/or across settings National Institute of Mental Health NIMH encourages research that addresses Institute priorities and is aligned with these recommended areas for domestic and global mental health research. Applicants may consider using the Research Domain Criteria (RDoC; https://www.nimh.nih.gov/research/research-funded-by-nimh/rdoc) approach in their work. Areas of interest include, but are not limited to: Applications on advancing methods for analyzing complex and dynamic systems that impact mental health disparities, including research on methods for estimating non-linear, dynamic, and time-varying relationships between SDOH and disparities in mental health service use, delivery and outcomes. Research on advancing methods for multilevel models examining mutable factors associated with disparities in mental health service use, delivery, and outcomes. Applications developing and/or refining methods for adequately powered analyses of mental health disparities experienced by smaller groups or subpopulations (e.g., when addressing intersectionality, conducting subgroup analyses) and low base rate mental health events (e.g., suicide deaths). Research to develop and validate measures and methods for expanding data capacity to appropriately represent disparities populations, incorporate SDOH, and reduce algorithmic bias in artificial intelligence and machine learning approaches for understanding risk and optimizing mental health care for populations with mental health disparities. Research to develop and validate measures and methods for integration of SDOH in health care decision-making processes and examine the impact of such integration on reducing disparities and achieving equity in mental health services outcomes. Research to develop or refine causal inference methods within quasi-experimental designs (e.g. General Causal Model, Directed Acyclic Graphs, Deterministic Structural Equation Models, Probabilistic Causal Models, Instrumental Variables), to address research questions addressing mental health equity for mental health disparity populations. Research to develop measures of quality of mental health care for mental health disparity populations. Development and validation of mental health measures that can be submitted to and endorsed by the National Quality Forum (https://www.qualityforum.org/map/) for use to advance equity and quality in mental health care as part of the Healthcare Effectiveness Data and Information Set (HEDIS; https://www.cms.gov/Medicare/Health-Plans/SpecialNeedsPlans/SNP-HEDIS) or as a quality indicator for the Centers for Medicare and Medicaid Services (https://www.cms.gov/). Metrics that elucidate mechanisms at the individual, community, and organizational levels that result in disparities in specific adverse mental health outcomes across the lifespan, especially those that can point towards therapeutic targets. Assessments of how structural racism and discrimination impact trajectories of mental health disorders across the lifespan, particularly focusing on sequential and integrative relationships across neural, behavioral, and environmental factors that lead to disparities in mental health outcomes. Measures that systematically and reliably quantify individual exposure to factors that drive mental health disparities, including rigorous, lifestage-appropriate, and repeatable measures of environmental and sociocultural factors like neighborhood effects, access to and quality of healthcare, food and resource security, intersectionality, and cultural beliefs. Research on measures and approaches to be used in basic studies in healthy populations of interest addressing mechanisms of complex social, cognitive, affective and behavioral functioning. National Institute on Aging (NIA) NIA supports research to understand health differences and health inequities associated with race, ethnicity, gender, environment, socioeconomic status (SES), geography, access, and sociocultural factors over the life course and their impact on aging processes, and aging-relevant outcomes including Alzheimer’s disease and Alzheimer’s disease related dementias (AD/ADRD). The goals of this initiative are to (1) identify the environmental, social, cultural, and behavioral factors that drive disparities in health, well-being, healthcare, and mortality; and (2) develop strategies to reduce or eliminate those disparities and promote active life expectancy and improve the health status of diverse midlife and older adults. NIA's Health Disparities Research Framework reflects levels of analysis researchers might consider across each of the four domains, refines the causal pathways, and further refines potentially adaptable targets for interventions. Additionally, the framework reflects priorities and investments made in this important aging research area. The framework could also facilitate researchers identifying relevant expertise needed to expand their team and ultimately accomplish the proposed study’s goals and objectives. NIA’s interests in PAR-22-072, “Measures and Methods to Advance Research on Minority Health and Health Disparities-Related Constructs” include, but are not limited to, development of, or enhancements to, measures or methods for assessing constructs related to minority health and health disparities, such as the following: Methods that capture composite and cumulative exposure to adversity, structural racism, and discrimination. Measurement of protective (and resilience) factors that contribute to (or buffer against) health disparities in AD/ADRD outcomes, at both the individual (e.g., personality traits, psychological resources, behavioral skills) and sociocultural levels (e.g., interpersonal, community, societal). Analytic methods to generate causal evidence from observational and non-clinical studies to inform the prevention and mitigation of health disparities in AD/ADRD and increase confidence in observational results as evidence of treatment efficacy or effectiveness in populations underrepresented in AD/ADRD research. Development of analytical tools to dynamically assess health and exposure to risk and protective factors across multiple timescales, including mobile technology-based measures that capture lived experiences in “real time,” without imposing undue burden, particularly for populations that experience health disparities. Development of analytical tools and methods to promote and support research on the impact of social factors on molecular, cellular, genetic, and physiological mechanisms underlying disparate outcomes in aging and age-related pathologies, particularly for populations that experience health disparities. Development of approaches that integrate qualitative and quantitative data collection methods and measures of diverse environmental factors (chemical, physical, built, etc.) with social and behavioral factors associated with aging and age-related neuro-pathologies, including AD/ADRD. Development and use of methods for integrating social and behavioral data with molecular, cellular, genomic, other -omic and biological data in epidemiological studies of aging and age-related neuro-pathologies, including AD/ADRD. Methods to harmonize measures and conduct analyses using longitudinal cohort studies with heterogenous representation of individuals across different health disparities populations using NIA's Health Disparities Research Framework (i.e., across levels of analysis). Applications Not responsive to the FOA: Projects not conducting measurement and methodologic research, Projects conducting primary data collection outside of the U.S., and Projects that are exclusively qualitative. Non-responsive applications will not be reviewed. Applicants are strongly encouraged to reach out to the relevant scientific contacts to discuss whether their applications are responsive.

The National Institutes of Health (NIH) hereby notify recipient organizations holding specific types of NIH grants, listed in the full Funding Opportunity Announcement (FOA), that applications for change of recipient organization may be submitted to this FOA. This assumes such a change is programmatically permitted for the particular grant. Applications for change of recipient organization are considered prior approval requests (as described in Section 8.1.2.7 of the NIH Grants Policy Statement) and will be routed for consideration directly to the Grants Management Specialist named in the current award. Although requests for change of recipient organization may be submitted through this FOA, there is no guarantee that an award will be transferred to the new organization. All applicants are encouraged to discuss potential requests with the awarding IC before submission.

The purpose of this Funding Opportunity Announcement (FOA) is to support innovative population-based research that can contribute to identifying and characterizing pathways and mechanisms through which work or occupation influences health outcomes and health status among populations with health and/or health care disparities, and how work functions as a social determinant of health.The main objective of this initiative is to determine the extent and mechanisms by which work as a SDOH both contributes to, and helps ameliorate, health and health care disparities. A recent workshop on September 28-29, 2020 organized by NIMHD (https://www.nimhd.nih.gov/news-events/conferences-events/hd-workshop.html) highlighted key ideas for furthering research on work as a SDOH that include conceptualizing work as a social class marker, as a source of exposures and risk factors, and as a source of beneficial social and economic resources such as income and wealth, neighborhood conditions, health care access, education, and social networks. Some key questions include: What are the specific and modifiable mechanisms by which work explains health disparities? To what extent does work as a social class marker, source of exposures and risk factors and/or source of beneficial social and economic resources explain health disparities? Which health disparities does work as a SDOH explain? Of particular interest are projects designed to examine pathways and mechanisms using conceptual model(s) grounded in minority health and health disparities theories that recognize that health disparities arise by multiple and overlapping contributing factors acting at multiple levels of influence (See the NIMHD Research Framework, https://www.nimhd.nih.gov/about/overview/research-framework.html). Studies must examine NIH-designated U.S. health disparity populations, e.g. racial and ethnic minority populations, sexual and gender minority groups, underserved rural populations, and socioeconomically disadvantaged populations of any race or ethnicity (https://www.nimhd.nih.gov/about/overview/). Studies involving primary data collection with human participants are strongly encouraged to incorporate SDOH measures from the Core and Specialty collections that are available in the Social Determinants of Health Collection of the PhenX Toolkit (www.phenxtoolkit.org). Of interest are intersectional approaches that consider different social identities and the embeddedness of individuals within families, households, and communities. Life course approaches that consider the role of work in shaping cumulative processes and critical transitions including periods of unemployment, under-employment, and unpaid and informal work arrangements, are also encouraged. Also, of interest is considering the role of work at the household level with influences on the health of partners and extended families, and the intergenerational transmission to children and their health. In addition, exploring the role of inequity-generating mechanisms that constrain choices around work and health such as racism and discrimination by sex, age, marital status, immigration status, social class, and other power structures is also encouraged. Additionally, of interest are projects that explore whether work can explain the health or health care disparities seen within diseases or conditions (e.g., COVID-19, opioid use disorder, mental/behavioral health, diabetes, cancer, heart disease, asthma, and maternal and infant health ) as well as disparities in co-morbidities and general indicators of health such as greater global burden of disease, quality of life, and daily functioning. Projects that utilize a syndemics lens (i.e., multiple disease states that are interlinked because of social, environmental, and structural conditions), to examine the role of work in disparities in co-occurring health conditions, are encouraged. Also, of interest are projects that explore how work contributes to health care disparities including but not limited to disparities in access to preventive, specialty, and emergency care, in health insurance coverage, and in quality of health care. Moreover, given the reciprocal relationship between work and health, of interest are projects that examine how health impacts access to different work opportunities, working conditions, and work benefits, and how that varies by different social identities. Projects may involve primary data collection and/or secondary analysis of existing datasets. Projects may utilize observational studies, natural experiments, quasi-experiments, simulation modeling, as well as use of large-scale longitudinal data sets, data mining techniques, registries, surveillance data, and linking to administrative data sets such as the Occupational Information Network (O*NET). Quantitative and mixed methods approaches are encouraged. Investigators are encouraged as appropriate for the research questions posed, to forge research collaborations with community partners and stakeholders in the conceptualization, planning and implementation of the research to generate better-informed hypotheses and enhance the translation of the research results into practice.

The NIH Research Education Program (R25) supports research education activities in the mission areas of the NIH. The over-arching goal of this R25 program is to support educational activities that foster a better understanding of biomedical, behavioral and clinical research and its implications. To accomplish the stated over-arching goal, this FOA will support creative educational activities with a primary focus on research experiences for high school or undergraduate students or science teachers during the summer academic break. The proposed program needs to fit within the mission of the participating IC that the application is being submitted to and should not have a general STEM focus (see below and Table of IC-Specific Information and Points of Contact).

This funding opportunity provides financial support to researchers with active NIH grants to address unexpected costs and enhance their projects without changing the original research scope.

This notice is not a mechanism to fund existing NOAA awards. The purpose of this notice is to request applications for special projects and programs associated with NOAA's strategic plan and mission goals, as well as to provide the general public with information and guidelines on how NOAA will select applications and administer discretionary Federal assistance under this Broad Agency Announcement (BAA).This Broad Agency Announcement is a mechanism to encourage research, education and outreach, innovative projects, or sponsorships that are not addressed through NOAA’s competitive discretionary programs. This announcement is not soliciting goods or services for the direct benefit of NOAA. Funding for activities described in this notice is contingent upon the availability of Fiscal Year 2021, Fiscal Year 2022, and Fiscal Year 2023 appropriations. Applicants are hereby given notice that funds have not yet been appropriated for any activities described in this notice. Publication of this announcement does not oblige NOAA to review an application beyond an initial administrative review, or to award any specific project, or to obligate any available funds. As an agency with responsibilities for maintaining and improving the viability of marine and coastal ecosystems, for delivering valuable weather, climate, and water information and services, for understanding the science and consequences of climate change, and for supporting the global commerce and transportation upon which we all depend, NOAA must remain current and responsive in an ever-changing world. We do this in concert with our partners and stakeholders in Federal, state, and local governments and private organizations, applying a systematic approach that links our strategic goals through multi-year plans to the daily activities of our employees. Every year we are committed to re-evaluate our progress and priorities, look for efficiencies, and take advantage of new opportunities to improve our information, products, and services. In furtherance of this objective, NOAA issues this BAA for extramural research, innovative projects, and sponsorships (e.g., conferences, newsletters, etc.) that address one or more of the following four mission goal descriptions contained in the NOAA Strategic Plan: Climate Adaptation and Mitigation Weather-Ready Nation Healthy Oceans Resilient Coastal Communities and Economies

This funding opportunity supports U.S. researchers and institutions investigating the interactions between plants and various organisms, aiming to enhance agricultural practices through a better understanding of these biotic relationships.

The primary purpose of the NIH Mentored Clinical Scientist Research Career Development Awards (K08) program is to prepare qualified individuals for careers that have a significant impact on the health-related research needs of the Nation. This program represents the continuation of a long-standing NIH program that provides support and "protected time" to individuals with a clinical doctoral degree for an intensive, supervised research career development experience in the fields of biomedical and behavioral research, including translational research.

The primary purpose of the NIH Mentored Clinical Scientist Research Career Development Awards (K08) program is to prepare qualified individuals for careers that have a significant impact on the health-related research needs of the Nation. This program represents the continuation of a long-standing NIH program that provides support and "protected time" to individuals with a clinical doctoral degree for an intensive, supervised research career development experience in the fields of biomedical and behavioral research, including translational research.

The primary purpose of the NIH Mentored Clinical Scientist Research Career Development Awards (K08) program is to prepare qualified individuals for careers that have a significant impact on the health-related research needs of the Nation. This program represents the continuation of a long-standing NIH program that provides support and "protected time" to individuals with a clinical doctoral degree for an intensive, supervised research career development experience in the fields of biomedical and behavioral research, including translational research.

The purpose of the Mentored Quantitative Research Career Development Award (K25) is to attract to NIH-relevant research those investigators whose quantitative science and engineering research has thus far not been focused primarily on questions of health and disease. The K25 award will provide support and "protected time" for a period of supervised study and research for productive professionals with quantitative (e.g., mathematics, statistics, economics, computer science, imaging science, informatics, physics, chemistry) and engineering backgrounds to integrate their expertise with NIH-relevant research. This Funding Opportunity Announcement (FOA) is designed specifically for applicants proposing to serve as the lead investigator of an independent clinical trial, a clinical trial feasibility study, or a separate ancillary clinical trial, as part of their research and career development. Applicants not planning an independent clinical trial, or proposing to gain research experience in a clinical trial led by another investigator, must apply to companion FOA.

The purpose of the Mentored Quantitative Research Career Development Award (K25) is to attract to NIH-relevant research those investigators whose quantitative science and engineering research has thus far not been focused primarily on questions of health and disease. The K25 award will provide support and "protected time" for a period of supervised study and research for productive professionals with quantitative (e.g., mathematics, statistics, economics, computer science, imaging science, informatics, physics, chemistry) and engineering backgrounds to integrate their expertise with NIH-relevant research.

The purpose of the NIH Midcareer Investigator Award in Patient-Oriented Research (K24) is to provide support to mid-career health-professional doctorates for protected time to devote to patient-oriented research (POR) and to act as research mentors primarily for clinical residents, clinical fellows and/or junior clinical faculty. Section I. Funding Opportunity Description The overall goal of the NIH Research Career Development program is to help ensure that a diverse pool of highly trained scientists is available in appropriate scientific disciplines to address the Nation's biomedical, behavioral, and clinical research needs. NIH Institutes and Centers (ICs) support a variety of mentored and non-mentored career development award programs designed to foster the transition of new investigators to research independence and to support established investigators in achieving specific objectives. Candidates should review the different career development (K) award programs to determine the best program to support their goals. More information about Career programs may be found at the NIH Extramural Training Mechanisms website. The NIH Midcareer Investigator Award in Patient-Oriented Research (K24) is designed to enable mid-career clinician-scientists to: Devote more time to augment their capabilities in Patient-Oriented Research (POR); and Provide mentoring to junior clinical investigators in the conduct of POR (see below for definition). The K24 award is intended to provide protected time to mid-career clinical investigators to provide mentoring to junior clinical investigators, particularly K23 grantees, in POR and to stabilize the careers of these investigators. The intent is to allow these investigators to continue to conduct POR and be available as mentors in POR. It is expected that K24 recipients will obtain new or additional independent, peer-reviewed funding for POR as PD/PI and establish and assume leadership roles in collaborative POR programs. In addition, it is expected that there will be an increased effort and commitment to act as a mentor to beginning clinician investigators in POR to enhance the research productivity of both the K24 investigator and increase the pool of well-trained clinical researchers of the future. For the purposes of the K24 award, Patient-Oriented Research is defined as research conducted with human subjects (or on material of human origin such as tissues, specimens and cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects. This area of research includes: (1) mechanisms of human disease; (2) therapeutic interventions; (3) clinical trials, and; (4) the development of new technologies. Excluded from this definition are in vitro studies that utilize human tissues but do not deal directly with patients. In other words, patient-oriented research is research in which it is necessary to know the identity of the patients from whom the cells or tissues under study are derived. Studies falling under Exemption 4 for human subjects research are not included in this definition. See also the NIH Director's Panel on Clinical Research Report. NIH defines a clinical trial as "A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes." (NOT-OD-15-015). NIH not only supports trials of safety and efficacy, it also supports mechanistic exploratory studies that meet the definition of a clinical trial and are designed to explore or understand a biological or behavioral process, the pathophysiology of a disease, or the mechanism of action of an intervention. These studies may focus on basic and/or translational discovery research in healthy human subjects and in human subjects who are affected by the pathophysiology of diseases and disorders. By addressing basic questions and concepts in biology, behavior, and pathophysiology, these studies may provide insight into understanding human diseases and disorders along with potential treatments or preventive strategies. NIH also supports biomarker studies that meet the definition of a clinical trial and that may provide information about physiological function, target engagement of novel therapeutics, and/or the impact of therapeutics on treatment response. NIH thus supports studies that meet the definition of clinical trials (as noted above) but do not seek to establish safety, clinical efficacy, effectiveness, clinical management, and/or implementation of preventive, therapeutic, and services interventions. Note: This Funding Opportunity Announcement (FOA) is designed specifically for applicants proposing to serve as the lead investigator of an independent clinical trial, a clinical trial feasibility study, or a separate ancillary clinical trial, as part of their research and career development. Applicants not planning an independent clinical trial, or proposing to gain research experience in a clinical trial led by another investigator, must apply to companion FOA Special Note: Because of the differences in individual Institute and Center (IC) program requirements for this FOA, prospective candidates are strongly encouraged to consult the Table of IC-Specific Information, Requirements and Staff Contacts, to make sure that their application is appropriate for the requirements of one of the participating NIH ICs. See Section VIII. Other Information for award authorities and regulations. Section II. Award Information Funding Instrument Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity. Application Types Allowed New Resubmission Revision Renewal The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA. Clinical Trial? Required: Only accepting applications that propose an independent clinical trial(s) Need help determining whether you are doing a clinical trial? Funds Available and Anticipated Number of Awards The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications. Award Budget Award budgets are composed of salary and other program-related expenses, as described below. Award Project Period The total project period may not exceed 5 years.

The purpose of the NIH Midcareer Investigator Award in Patient-Oriented Research (K24) is to provide support to mid-career health-professional doctorates for protected time to devote to patient-oriented research (POR) and to act as research mentors primarily for clinical residents, clinical fellows and/or junior clinical faculty. Level of Effort Candidates must be able to demonstrate the need for protected time, 3-6 person months (25-50% of full-time professional effort) for a period of intensive research focus as a means of augmenting their capabilities in POR and ability to act as a mentor to new clinical investigators in the conduct of POR during this period. Candidates for the K24 award may not concurrently apply for any other PHS career award or have another PHS career award pending review. Candidates who have VA appointments may not consider part of the VA effort toward satisfying the full time requirement at the applicant institution. Candidates with VA appointments should contact the staff person in the relevant Institute or Center prior to preparing an application to discuss their eligibility. After the receipt of the award, adjustments to the required level of effort may be made in certain circumstances. See NOT-OD-09-036 for more details. Renewals Depending on the policies of the sponsoring NIH Institute/Center, awardees may apply for a one-time renewal for an additional three to five years of support if the recipient continues to have independent peer-reviewed research support at the time of submission of the renewal application. Candidates should clearly demonstrate their continuing need for protected time to expand their research programs. Peer-Reviewed Research Support Depending on the policies of the sponsoring NIH Institute/Center, candidates are expected to continue to hold independent peer-reviewed research support for the period of this award. Candidates losing this support during the award period must document in their annual Progress Reports efforts to replace this support and demonstrate that they continue to meet all other requirements of the career award. Institutional Environment The applicant institution must have a strong, well-established record of research and career development activities and faculty qualified to serve as mentors in biomedical, behavioral, or clinical research.

The purpose of the NIH Midcareer Investigator Award in Patient-Oriented Research (K24) is to provide support to mid-career health-professional doctorates for protected time to devote to patient-oriented research (POR) and to act as research mentors primarily for clinical residents, clinical fellows and/or junior clinical faculty. Section IV. Application and Submission Information 1. Requesting an Application Package The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution. 2. Content and Form of Application Submission It is critical that applicants follow the Career Development (K) Instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review. Page Limitations All page limitations described in the SF424 (R&R) Application Guide and the Table of Page Limits must be followed. Instructions for Application Submission Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing (DMS) Plan will be attached in the Other Plan(s) attachment in FORMS-H and subsequent application forms packages. For due dates on or before January 24, 2023, the Data Sharing Plan and Genomic Data Sharing Plan GDS) will continue to be attached in the Resource Sharing Plan attachment in FORMS-G application forms packages. The following section supplements the instructions found in the SF 424 (R&R) Application Guide and should be used for preparing an application to this FOA. SF424(R&R) Cover All instructions in the SF424 (R&R) Application Guide must be followed. SF424(R&R) Project/Performance Site Locations All instructions in the SF424 (R&R) Application Guide must be followed. Other Project Information All instructions in the SF424 (R&R) Application Guide must be followed SF424(R&R) Senior/Key Person Profile Expanded All instructions in the SF424 (R&R) Application Guide must be followed. IMPORTANT REMINDER: The personal profile associated with the eRA Commons username entered in the Credential field for the PD/PI (candidate) must include an ORCID ID. For more information on linking an ORCID ID to an eRA Commons personal profile see the ORCID topic in our eRA Commons online help. R&R Budget All instructions in the SF424 (R&R) Application Guide must be followed. PHS 398 Cover Page Supplement All instructions in the SF424 (R&R) Application Guide must be followed. PHS 398 Career Development Award Supplemental Form Other Plan(s): Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H and subsequent application forms packages. For due dates on or before January 24, 2023, the Data Sharing Plan and Genomic Data Sharing Plan GDS) will continue to be attached in the Resource Sharing Plan attachment in FORMS-G application forms packages. All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan. The PHS 398 Career Development Award Supplemental Form is comprised of the following sections: Candidate Research Plan Other Candidate Information Mentor, Co-Mentor, Consultant, Collaborators Environment & Institutional Commitment to the Candidate Other Research Plan Sections Appendix All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions: Candidate Section All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions: Candidate Information and Goals for Career Development Candidate’s Background Provide details of the candidate’s immediate and long-term career objectives in POR and in mentoring new clinician investigators. Include a summary of the research career of the candidate, documenting the ability of the candidate to conduct high quality POR and commitment to a career in POR. Document the ability of the K24 candidate to provide mentoring to new clinician investigators without duplicating information in the biosketch. Provide the number of years of mentoring experience, mentoring role (i.e., research advisor, clinical mentor, etc.), the number of clinicians mentored, the specialties of the individual mentees and the stages in their professional career. In addition, describe the types of research that were conducted by the individuals mentored, and the proportion of mentored individuals currently in academic medicine and/or directly participating in POR. Provide an explanation as to how relief from patient care or administrative responsibilities through the protected time provided by this award will contribute to the development or expansion of the candidate’s POR program and increased level of commitment to mentoring new and early stage clinician investigators. It is important to convey to the reviewers the reasons for needing protected time to continue a vital research program and continue to engage in the mentoring of new scientists. It should be clear that this award will permit the candidate to spend more time on research and mentoring and less time on administrative and clinical responsibilities for the institution. Career Goals and Objectives Describe the candidate's career goals and objectives under this award, including prior experience, and current research support. Candidates are encouraged to provide a timeline for accomplishing these goals and how this award will enhance mentoring or inclusion of mentoring in their career activities. Candidate’s Plan for Career Development/Training Activities During Award Period Describe the professional responsibilities/activities including other research projects beyond the minimum required effort commitment to the career award. Explain how these responsibilities/activities will help ensure career progression to achieve independence as an investigator. The candidate should describe any new or enhanced research skills and knowledge he/she will acquire during the career award period, and how these skills and experiences will significantly enhance his/her ability to continue his/her research programs as an independent scientist. Research Plan Section All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions: Research Strategy Currently supported research: There is no need to provide extensive detail with regard to ongoing, funded research. Enough information should, however, be provided in the areas of Hypotheses and Specific Aims; Background, Significance and Rationale; Preliminary Studies and Results; and Research Design and Methods to permit the peer reviewers to evaluate the extent, special features and general quality of the candidate's research activities and opportunities for mentoring. New research to be specifically supported by this award: Describe how this award will be used to help augment the candidate’s research skills and/or develop new directions in POR. This description should include a Statement of Hypothesis and Specific Aims; Background, Preliminary Studies and Aims; Significance and Rationale; and Research Design and Methods. Although it is not expected that this description would be as detailed as an application for an investigator-initiated research grant (e.g., R01), it is expected that sufficient detail be provided to permit an evaluation of the scientific merit of the research, and to clearly show research opportunities for mentoring. Documentation must be provided that appropriate and adequate resources, both in terms of support and facilities are available to the candidate to conduct the research program(s). This is an important part of the application because it will provide the main rationale and justification for needing protected time for research. The candidate must ensure that the inclusion of women, members of minority groups and their subpopulations, and children, has been addressed in the development of the design for all proposed patient-oriented research. The candidate must provide this information for each new research project proposed. Candidates must provide plans for ensuring continuing support of their POR programs preferably with them as the PD/PI. If the applicant is proposing to gain experience in a clinical trial, ancillary clinical trial or a clinical trial feasibility study as part of his or her research career development, describe the relationship of the proposed research project to the clinical trial. Training in the Responsible Conduct of Research All applications must include a plan to fulfill NIH requirements for instruction in the Responsible Conduct of Research (RCR). See SF424 (R&R) Application Guide for instructions. Other Candidate Information Section Candidate's Plan to Provide Mentoring This required component should include a description of the availability of appropriate junior investigators for mentoring; their previous training and specialization; plans for recruitment, selection and supervision; the types of educational and research experiences that will be provided; and the capacity in which the candidate for the career award will serve as a mentor. If there is an existing (clinical) research curriculum (e.g., through a CTSA), describe how the mentoring plan will be integrated with the curriculum. Candidates must also describe a plan for supporting the research of their mentees during the period of the career award. Candidates must indicate the proposed person months committed to the mentoring plan. Mentor, Co-Mentor, Consultant, Collaborators Section All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions: Plans and Statements of Mentor and Co-mentor(s) Not Applicable Letters of Support from Collaborators, Contributors and Consultants Signed statements must be provided by all collaborators and/or consultants confirming their participation in the project and describing their specific roles. Collaborators and consultants do not need to provide their biographical sketches unless also listed as senior/key personnel. However, information should be provided clearly documenting the appropriate expertise in the proposed areas of consulting/collaboration. Environmental and Institutional Commitment to the Candidate All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions: Description of Institutional Environment The sponsoring institution must document a strong, well-established research and career development program related to the candidate's area of interest, including a high-quality research environment with key faculty members and other investigators capable of productive collaboration with the candidate. Describe how the institutional research environment is particularly suited for the development of the candidate's research career and the pursuit of the proposed research plan. Describe the resources and facilities that will be available to the candidate Institutional Commitment to the Candidate’s Research Career Development The sponsoring institution must provide a statement of commitment to the candidate's development into a productive, independent investigator and to meeting the requirements of this award. It should be clear that the institutional commitment to the candidate is not contingent upon receipt of this career award. The letter of commitment from the institution should provide statements concerning the amount of protected time the candidate will receive (3-6 person-months or 25 to 50% full-time professional effort required); the duties from which he/she will be relieved (if clinical duties, the institution should describe specific steps that will be taken to cover these duties, such as hiring clinical staff); and the institutional commitment to enhancing the candidate's ability to be a productive, independent investigator. Appendix Limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions. PHS Human Subjects and Clinical Trials Information When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions: If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record. Study Record: PHS Human Subjects and Clinical Trials Information All instructions in the SF424 (R&R) Application Guide must be followed with the following additional instructions: Do not complete Section 4 – Protocol Synopsis information or Section 5 - Other Clinical Trial-related Attachments. Delayed Onset Study Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the SF424 (R&R) Application Guide must be followed. PHS Assignment Request Form All instructions in the SF424 (R&R) Application Guide must be followed. 3. Unique Entity Identifier and System for Award Management (SAM) See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov. 4. Submission Dates and Times Part I. Overview Information contains information about Key Dates and Times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day. Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies) using ASSIST or other electronic submission systems. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date. and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission. Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission. Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide. 5. Intergovernmental Review (E.O. 12372) This initiative is not subject to intergovernmental review. 6. Funding Restrictions All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. Pre-award costs are allowable only as described in the NIH Grants Policy Statement. 7. Other Submission Requirements and Information Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted. Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration. For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply – Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission contact the Application Submission Contacts in Section VII. Important reminders: All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management (SAM). Additional information may be found in the SF424 (R&R) Application Guide. See more tips for avoiding common errors. Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review, NIH. Applications that are incomplete or non-compliant will not be reviewed. Post Submission Materials Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy. Section V. Application Review Information 1. Criteria Note: Effective for due dates on or after January 25, 2023, the Data Sharing Plan and Genomic Data Sharing Plan (GDS) as part of the Resource Sharing Plan will not be evaluated at time of review. Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system. Overall Impact Reviewers should provide their assessment of the likelihood that the proposed career development and research plan will enhance the candidate’s potential for a productive, independent scientific research career in a health-related field, taking into consideration the criteria below in determining the overall impact score. Scored Review Criteria Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. Candidate Is there evidence of ongoing high quality patient-oriented research, and what is the relationship of that research to this K24 application? Is there evidence of the candidate's capabilities and commitment to serve as a mentor for new clinical investigators in the conduct of patient-oriented research? Does the application demonstrate that the proposed program and protected time will relieve the candidate from non-research patient care and administrative duties and allow him/her to devote additional time and to augment his/her capabilities in patient-oriented research? Does the application demonstrate a record of independent peer-reviewed support for patient-oriented research that is likely to continue during the K24 award? Plan to Provide Mentoring Are the plans to provide mentoring or supervising new clinical investigators in patient oriented research adequate? Are plans to integrate appropriate clinical research curricula, into the mentoring plans adequate? Is an appropriate level of effort proposed for the mentoring component? Research Plan Candidates are expected to have independent, peer reviewed research support at the time the career award is made. In such instances, reviewers should not re-evaluate the research plan. Rather, the reviewers should evaluate how the research and career development plans together further the candidate’s research career. Is the research plan an appropriate vehicle for demonstrating and developing the prospective mentee’s skills and capabilities in patient-oriented research? Are the scientific and technical plans of the proposed research of merit? Is the proposed research relevant to the candidate's career objectives? Are adequate resources available to conduct the research program? This includes adequacy of plans for continued support of the research during the funding period of the grant. If proposed, will the clinical trial experience contribute to the proposed research project? Consultant(s), Collaborator(s) Is adequate information provided that clearly documents expertise in the proposed area(s) of consulting/collaboration? Environment & Institutional Commitment to the Candidate Are the research facilities, resources and training opportunities, including faculty capable of productive collaboration with the candidate adequate and appropriate? Is there assurance that the institution intends the candidate to be an integral part of its research program as an independent investigator? Is the level of the applicant institution’s commitment to the scientific development of the candidate appropriate? Are the size and quality of the pool of clinician investigators to be mentored by the PD/PI adequate? Are the quality and relevance of the environment for continuing the scientific and professional development of the candidate and for others pursuing patient-oriented research appropriate and adequate? Is there adequate commitment from the sponsoring institution to provide protected time for the candidate to conduct the research and mentoring program? Is the level of commitment of the candidate’s institution to the career development in patient-oriented research of new clinical investigators mentored by the candidate adequate? Additional Review Criteria As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items. Protections for Human Subjects For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: (1) risk to subjects, (2) adequacy of protection against risks, (3) potential benefits to the subjects and others, (4) importance of the knowledge to be gained, and (5) data and safety monitoring for clinical trials. For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: (1) the justification for the exemption, (2) human subjects involvement and characteristics, and (3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects. Inclusion of Women, Minorities, and Individuals Across the Lifespan When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals across the lifespan (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research. Vertebrate Animals The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section. Biohazards Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed. Resubmissions For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project. Renewals For Renewals, the committee will consider the progress made in the last funding period. Revisions For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

The purpose of the NIH Pathway to Independence Award (K99/R00) program is to increase and maintain a strong cohort of new and talented, NIH-supported, independent investigators. This program is designed to facilitate a timely transition of outstanding postdoctoral researchers with a research and/or clinical doctorate degree from mentored, postdoctoral research positions to independent, tenure-track or equivalent faculty positions. The program will provide independent NIH research support during this transition in order to help awardees to launch competitive, independent research careers. Frequently Asked Questions for NOT-HL-23-083 General Questions Q: What is the purpose of the Notice of Special Interest (NOSI) NOT-HL-23-083? The NOSI on Assessing Real-World Effectiveness and Implementation of Telehealth-Guided Provider-to-Provider Communication among Rural Communities (NOT-HL-23-083) aims to support research that generates evidence on the real-world effectiveness of telehealth collaboration among healthcare providers for consultation, second opinions, and other purposes, referred to as provider-to-provider telehealth (PPT). The NOSI is intended to support the use of telehealth interventions and tools for the prevention, management and treatment of heart, lung, blood, and sleep conditions, as well as cancer, in rural communities. Q: Are foreign applications allowed under this NOSI? Yes. Non-domestic entities (Foreign Institutions) and Non-domestic components of U.S. Organizations are eligible to apply under the Notice of Funding Opportunities (NOFOs) relevant to this NOSI (PA-20-185; PAR-22-105; PAR-21-035; PAR-21-341) – additional information regarding eligibility is available in Section III. Eligibility Information of each NOFO. Q: How is “rural” defined for the purposes of this NOSI? Different definitions of “rural” are used by various entities for different purposes. Rurality can be conceptualized based on administrative boundaries, land-use patterns, or economic influence; can reflect several different dimensions, such as population density, population size, and degree of remoteness; and can be delineated at different spatial scales (e.g., zip code, county, census district). Applicants should operationalize “rural” in the way that best serves the aims of their study. However, applicants should clearly state how they are defining rural in their application and provide a justification for the criteria they are using. A few widely used classification systems for defining rural and urban areas are provided below. Additionally, the Health Resources and Services Administration (HRSA) provides a tool on their website that enables users to see whether a specified geographic area is considered “rural” for the purposes of HRSA Rural Health Grant eligibility: https://data.hrsa.gov/tools/rural-healthexternal link. This may be a good starting point for assessing whether an area of interest might be considered “rural”. Census Bureau Urban-Rural Classificationsexternal link - The Census Bureau delineates urban areas by applying specified criteria to the decennial census and other data. For the 2020 Census, an urban area comprises a densely settled core of census blocks that meet minimum housing unit density and/or population density requirements of having at least 2,000 housing units or a population of at least 5,000. This includes adjacent territory containing non-residential urban land uses. Rural areas encompass all population, housing, and territory not included within an urban area. National Center for Health Statistics (NCHS) Urban-Rural Classification Scheme for Countiesexternal link – NCHS has developed a six-level urban-rural classification scheme for U.S. counties and county-equivalent entities. The scheme is based on the Office of Management and Budget’s (OMB) delineation of metropolitan statistical areas (MSA) and micropolitan statistical areas, as well as Vintage postcensal estimates of the resident U.S. population. The scheme has two levels nonmetropolitan counties. USDA Rural Urban Continuum Codes (RUCC)external link - Rural-Urban Continuum Codes are a 9-level classification scheme that categorizes metropolitan counties by the population size of their metro area, and nonmetropolitan counties by their degree of urbanization and adjacency to a metro area. USDA Rural Urban Commuting Area (RUCA) Codesexternal link - RUCA codes categorize census tracts based on measures of population density, urbanization, and daily commuting patterns. This classification system consists of 10 levels that delineate metropolitan, micropolitan, small town, and rural commuting areas based on the size and direction of the primary (largest) commuting flows. These 10 codes are further subdivided based on secondary commuting flows. USDA Urban Influence Codesexternal link (UIC) – Urban influence codes are a 12-level classification scheme that distinguishes metropolitan counties by the population size of their metro area, and nonmetropolitan counties by the size of the largest city or town and proximity to metro and micropolitan areas. There are two metro and ten nonmetro categories. Frontier and Remote Area (FAR) Codesexternal link – Developed by the USDA Economic Research Service, Frontier and Remote Area codes are based on ZIP-codes. The term "frontier and remote" is used to describe territory characterized by some combination of low population size and high geographic remoteness. FAR areas are defined in relation to the time it takes to travel by car to the edges of nearby Urban Areas (UAs)external link. Four levels are necessary because rural areas experience degrees of remoteness at higher or lower population levels that affect access to different types of goods and services. Q: My project focuses on “direct-to-consumer/ direct-to-patient” telehealth, would it still be responsive to this NOSI? No. This NOSI focuses on “provider-to-provider” telehealth (PPT), which is a telehealth modality that fosters collaboration among healthcare providers for consultation, second opinions, and other purposes. Please refer to the “Background” section of the NOSI for some examples of PPT in heart, lung blood, sleep and cancer conditions. Q. My university/institution is located in an urban area, would I still qualify for this NOSI? There is no restriction regarding the location of the Principal Investigator’s university, institution, or center and if it is in an urban or rural area. The limiting factor is the population of interest. The focus of this NOSI is the use of provider-to-provider telehealth (PPT) to benefit rural communities. For the definition of rural areas, please refer to the previous questions “How is “rural” defined for the purposes of this NOSI?” Q. One of the components of my research involves a center or hospital located in an urban center/hospital, would I still qualify for this NOSI? It depends. The focus of this NOSI is the use of provider-to-provider telehealth (PPT) to benefit rural communities. As such, considering a hub-and-spoke telehealth model, the healthcare providers who require consultation and their patients (spoke component) must be in a rural area, assuring that the benefited population served by the PPT intervention is rural. Example 1: If both communicating sides of providers (hub and spoke) are in urban areas, it is not responsive to this NOSI. Example 2: If the provider receiving the consultation or training (spoke) is in a rural area, and the consulted team (hub or hub-less provider) is in an urban area, it is responsive to this NOSI, given that the population of interest benefitted by the PPT intervention is still in a rural area. For the definition of rural areas, please refer to the previous questions “How is “rural” defined for the purposes of this NOSI?” Q. Is the NOSI restricted to telemedicine between physicians? No. The focus of the NOSI is not just telemedicine, but telehealth, which goes beyond the communication between physicians, and would include a series of healthcare providers, allied health providers, and their teams. For some examples, please refer to the “ Background” section of the NOSI. Q: What are some of the research examples that might be responsive to this NOSI? There are a series of research projects that might be of interest for this NOSI. For some examples, please refer to the ones listed in the “Selected Research Examples ” section of the NOSI. Please be aware that these are meant to illustrate some of the projects of interest for this NOSI, and other research projects not exemplified here might still be of interest. Investigators are encouraged to reach out to the Scientific and Research Contacts listed in the NOSI to discuss their research ideas and their relevance to the NOSI as well as institute funding priorities. Q. Who do I contact for more information from specific participating Institutes, Centers, and Offices? To whom should I direct my questions regarding this NOSI? To access the complete list of contacts, please refer to the “Inquiries” Section of the NOSI, which includes Scientific and Research Contacts and Financial/Grants Management Contacts. For programmatic questions at NHLBI, please contact Dr. Fernando P. Bruno [email protected]:, for programmatic questions at NCI, please contact Dr. Robin C. Vanderpool [email protected]:. If you have submission questions, please contact the eRA Service Desk. Application Preparation and Submission Questions Q: NHLBI and NCI are collaborating on this NOSI. If an applicant has a proposal that is relevant to both cancer and to heart, lung, blood, and sleep conditions, which institute will the application be assigned to? Applicants are advised to make use of the Assignment Request Form to request the institute they would prefer to act as the “Awarding Component.” These requests are taken into consideration. Applicants are further advised to consider the institute they plan to choose on the Assignment Request Form when framing their specific aims. The Awarding Component Section of the PHS Assignment Request Form * All assignment suggestions will be considered; however, not all assignment suggestions can be honored. Applications are assigned based on relevance of the application to an individual awarding component mission and scientific interests in addition to administrative requirements. * Applicants may enter up to three preferences for primary assignment in the boxes in the "Suggested Awarding Component(s)" row. Note: the application will be assigned based on the most appropriate match between it, the terms of the FOA, and the mission of each possible awarding component, with your preference(s) taken into consideration when possible. Applicants do not need to make entries in all three boxes of the "Awarding Component Assignment Suggestions" section. Q: If a proposal has aims that might be responsive to more than one eligible Notice of Funding Opportunity (NOFO) – should an investigator submit an application that is targeted at two different eligible funding opportunities, or separate those aims into two different applications and submit one to each corresponding NOFO? Each application in response to this NOSI must target only one of the eligible NOFOs. An applicant can elect to submit two different applications to two different NOFOs as long as the specific aims are sufficiently distinct. If the Division of Receipt and Referral determines there is significant overlap between the two applications, the applicant could be asked to withdraw one of them.

The purpose of the NIH Pathway to Independence Award (K99/R00) program is to increase and maintain a strong cohort of new and talented, NIH-supported, independent investigators. This program is designed to facilitate a timely transition of outstanding postdoctoral researchers with a research and/or clinical doctorate degree from mentored, postdoctoral research positions to independent, tenure-track or equivalent faculty positions. The program will provide independent NIH research support during this transition in order to help awardees to launch competitive, independent research careers.