Climate Change and Health Vulnerability and Adaptation Research Program

Climate Change and Health Vulnerability and Adaptation Research Program is sponsored by NIH National Institute of Environmental Health Sciences (NIEHS). Climate Change and Health Vulnerability and Adaptation Research Program is a grant from NIH National Institute of Environmental Health Sciences (NIEHS) that funds research on the health effects of climate change and development of community adaptation strategies.

Expired RFA-ES-23-007: Exploratory Grants for Climate Change and Health Research Center Development (P20 Clinical Trial Optional) This notice has expired. Check the NIH Guide for active opportunities and notices. Department of Health and Human Services Part 1.

Overview Information Participating Organization(s) National Institutes of Health ( NIH ) Components of Participating Organizations National Institute of Environmental Health Sciences ( NIEHS ) National Heart, Lung, and Blood Institute ( NHLBI ) 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 of Nursing Research ( NINR ) National Institute on Minority Health and Health Disparities ( NIMHD ) National Cancer Institute ( NCI ) Fogarty International Center ( FIC ) National Institute on Aging ( NIA ) 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.

Division of Program Coordination, Planning and Strategic Initiatives, Office of Disease Prevention ( ODP ) Funding Opportunity Title Exploratory Grants for Climate Change and Health Research Center Development (P20 Clinical Trial Optional) September 19, 2023 - Notice of Clarification of NIMH Research Priorities for RFA-ES-23-007 "Exploratory Grants for Climate Change and Health Research Center Development (P20 Clinical Trial Optional)".

See Notice NOT-MH-23-385 July 19, 2023 - Notice of Pre-Application Webinar for RFA-ES-23-007 "Exploratory Grants for Climate Change and Health Research Center Development (P20 Clinical Trial Optional)". See Notice NOT-ES-23-014 April 14, 2023 - Notice of NCI's Participation in RFA-ES-23-007. See Notice NOT-CA-23-062 .

March 24, 2023 - Notice of NINDS Participation in RFA-ES-23-007. See Notice NOT-NS-23-078 . March 17, 2023 - Notice of Changes to RFA-ES-23-007 .

See Notice NOT-ES-23-009 . March 9, 2023 - Notice of Participation of the National Institute on Aging (NIA) in RFA-ES-23-007 "Exploratory Grants for Climate Change and Health Research Center Development (P20 Clinical Trial Optional)".

See Notice NOT-AG-23-013 NOT-OD-22-189 - Implementation Details for the NIH Data Management and Sharing Policy NOT-OD-22-195 - New NIH "FORMS-H" Grant Application Forms and Instructions Coming for Due Dates on or after January 25, 2023 NOT-OD-22-198 - Implementation Changes for Genomic Data Sharing Plans Included with Applications Due on or after January 25, 2023 NOT-OD-23-012 - Reminder: FORMS-H Grant Application Forms & Instructions Must be Used for Due Dates On or After January 25, 2023 - New Grant Application Instructions Now Available Notice of Funding Opportunity (NOFO) Number Companion Notice of Funding Opportunity See Section III.

3. Additional Information on Eligibility . Assistance Listing Number(s) 93.

113, 93. 989, 93. 837, 93.

838, 93. 839, 93. 840, 93.

233, 93. 361, 93. 865, 93.

855, 93. 307, 93. 242, 93.

866, 93. 853, 93. 399 Notice of Funding Opportunity Purpose The purpose of this Notice of Funding Opportunity (NOFO) is to solicit P20 planning grant applications for Climate Change and Health Research Centers (CCHRCs).

This program will support the development of a transdisciplinary research environment to sustain a program of fundamental and applied research to examine the impacts of climate change on health and to develop action-oriented solutions to protect the health of individuals, communities, and nations from the hazards posed by climate change.

This opportunity will allow development of new research teams collaborating with communities and other partners to develop projects that generate data that will build or expand research capacity across a range of thematic scientific areas in support of the four core elements of the NIH’s Initiative in climate heath research: health effects research, health equity, intervention research, and training and capacity building ( https://www.

nih. gov/sites/default/files/research-training/initiatives/climate-change/nih-climate-change-framework. pdf ).

Open Date (Earliest Submission Date) Letter of Intent Due Date(s) April 1, 2023; October 7, 2023 Renewal / Resubmission / Revision (as allowed) All applications are due by 5:00 PM local time of applicant organization. Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

No late applications will be accepted for this Notice of Funding Opportunity. Required Application Instructions It is critical that applicants follow the Multi-Project (M) Instructions in the SF424 (R&R) Application Guide , except where instructed to do otherwise (in this NOFO or in a Notice from the NIH Guide for Grants and Contracts ).

Conformance to all requirements (both in the Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.

Applications that do not comply with these instructions may be delayed or not accepted for review. Part 1. Overview Information Part 2.

Full Text of Announcement Section I. Notice of Funding Opportunity Description Section II. Award Information Section III.

Eligibility Information Section IV. Application and Submission Information Section V. Application Review Information Section VI.

Award Administration Information Section VII. Agency Contacts Part 2. Full Text of Announcement Section I.

Notice of Funding Opportunity Description A changing climate will adversely impact human health through multiple direct and indirect effects on individuals and their communities. The purpose of this Notice of Funding Opportunity (NOFO) is to solicit P20 planning grant applications for Climate Change and Health Research Centers (CCHRCs).

This program will support the development of an innovative research environment to foster and sustain a transdisciplinary program of fundamental and applied research to explore the complex impacts of climate change on health and to develop action-oriented strategies that protect health and build resiliency at the individual, community, national and global levels.

A major goal for this program is to build research teams as well as collaborations with communities and other key partners. The program seeks innovative research and pilot/feasibility projects that utilize transdisciplinary approaches to address questions relevant to climate change impacts on health.

Applications for these CCHRCs should propose planning and development activities in preparation to build institutional research capacity for future proposals addressing climate and health.

NIH seeks to support a variety of these centers around the world and across a range of thematic scientific areas in support of the four core elements of the NIH’s investment in climate health research: health effects research, health equity, intervention research, and training and capacity building.

Each CCHRC is expected to: (1) plan and develop sustainable research capacity by establishing centralized resources and research infrastructure; (2) develop the Center’s thematic science area through transdisciplinary research activities; (3) enable research that will develop into new programs of science and research applications supporting independent investigators; (4) establish or build upon and maintain authentic partnerships to engage communities most likely to be impacted by climate change in all phases of the research process; and (5) actively participate in the NIH Research Coordinating Center to Support Climate Change and Health Community of Practice activities ( https://grants.

nih. gov/grants/guide/rfa-files/RFA-ES-22-003. html ).

NIH’s broad scientific scope uniquely positions the agency to understand and help address the complex set of factors that interact to create acute and chronic health burdens linked to climate change.

Climate drivers affect health outcomes directly through weather events such as extreme heat or cold, wildfires, droughts, storm surges, and floods, but also indirectly through exposure pathways such as air and water quality, food quality, infectious diseases, and massive population displacement events.

These pathways are themselves influenced by environmental contexts related to land use, geography, infrastructure, and agriculture, as well as social, cultural, behavioral, and economic contexts that create vulnerabilities associated with life stage, gender, poverty, housing quality, discrimination, access to care, and other Social Determinants of Health (SDoH).

Climate change is greatly expanding and modifying the landscape of threats to human health across a wide range of illnesses and injuries, including: asthma, respiratory allergies and airway diseases, cancers, cardiovascular disease and stroke, foodborne diseases and decreased nutrition, heat-related illness and deaths, reproductive and birth outcomes, and developmental effects, mental health conditions and neurological disorders, vector-borne and zoonotic diseases, waterborne diseases, and extreme weather-related morbidity and mortality.

As with many diseases and disorders, populations including children, older adults, women and pregnant women, and persons with disabilities, among others, may be disproportionally at risk. Strong evidence indicates that climate change also disproportionately adversely affects communities that experience socioeconomic, behavioral, and environmental vulnerabilities.

Such communities include populations that experience health disparities, especially racial and ethnic minority communities; high-poverty urban, rural, and Tribal communities; military and veteran populations; and those unduly burdened by exposure to environmental pollution ( www. nimhd. nih.

gov/about/overview ). In the global community, these same populations, as well as those living in extreme poverty and with poor access to health and economic services, are at a higher risk of experiencing health impacts of climate change. Most climate change and health research has been focused on documenting and understanding these emerging threats to populations around the world.

A more recent area of research explores how climate adaptation efforts can reduce health hazards. Adaptation refers to a diverse array of institutional, environmental, and technological interventions, including urban planning, housing, transportation, air quality management, improved water systems, flood control, vector control, and changes in health services, among others.

Importantly, other research has demonstrated opportunities for health co-benefits from system changes to mitigate climate change, including healthy buildings, improved agricultural practices, and nutritional security.

A complementary field of study is focused on health threats posed by potential unintended side effects of actions by energy, agriculture, transportation, health care, and other sectors to mitigate climate change and protect enterprises from losses due to extreme weather or gradually changing conditions.

These actions create natural experiments that are important in understanding how negative consequences can be avoided and health benefits maximized.

Considering the complexity of the issues to be addressed, including the recognition that many groups of individuals will be disproportionately impacted because of climate change and related events, applications submitted in response to this NOFO should propose innovative transdisciplinary approaches in support of a center structured around two or more of these four core elements. ( https://www. nih.

gov/sites/default/files/research-training/initiatives/climate-change/nih-climate-change-framework. pdf ) Key Definitions for the NOFO: Climate Change: Climate change is a long-term change in the average weather patterns that have come to define Earth’s local, regional, and global climates.

These changes have a broad range of observed effects including, but not limited to, global land and ocean temperature increases; rising sea levels; ice loss at Earth’s poles and in mountain glaciers; frequency and severity changes in extreme weather such as hurricanes, heatwaves, wildfires, droughts, floods, and precipitation; and cloud and vegetation cover changes.

Transdisciplinary: research efforts conducted by investigators from different disciplines working jointly to create new conceptual, theoretical, methodological, and translational innovations that integrate and move beyond discipline-specific approaches to address a common problem.

Health Disparities Populations: Racial and ethnic minorities (Black or African American, Hispanic or Latino, American Indian and Alaska Native, Asian, or Native Hawaiian and Pacific Islander persons), socioeconomically disadvantaged populations, underserved rural populations, and sexual and gender minorities in the U.S. and comparable populations globally. For more information: https://www. nimhd.

nih. gov/about/overview/ Social Determinants of Health (SDoH): Social determinants of health (SDoH) are the conditions in the environments where people are born, live, learn, work, play, worship, and age that affect a wide range of health, functioning, and quality of life outcomes.

SDoH can be grouped into five domains that include: economic stability, education access and quality, health care access and quality, neighborhood and built environment, social and community context. For a complete definition: https://health. gov/healthypeople/objectives-and-data/social-determinants-health .

Additional resource: https://www. phenxtoolkit. org/collections/view/6 The CCHRCs will propose activities to establish the research infrastructure necessary to foster and conduct transdisciplinary science that addresses a specific thematic topic of climate and health research that will advance the field towards solutions-oriented adaptation and implementation that takes into consideration the core elements described above.

Centers may consider exploring areas of research that address gaps in knowledge or feasibility of adaptation approaches for climate change impacts on health from a local, regional, national, or global perspective. The Center team will be led by established investigators and should consist of individuals from other disciplines as appropriate to the research being proposed and must also include community engagement.

Inclusion of at least one Early Stage Investigator as a Co-Investigator is required to include researchers not previously supported by NIH funding. Required Components for CCHR Centers Each CCHRC must address an interrelated set of activities relevant to a central theme that will provide new knowledge about how climate change impacts health.

Applications must contain the following: At least one, but no more than two, hypothesis-driven research Project(s) An Administrative Core including a data infrastructure plan and career development plans for any underrepresented biomedical researchers. A Community Engagement Core describing an engagement plan for research partners such as impacted communities or expected users of any tools or technology developed.

No more than two, additional Core(s) describing plans for research capacity building that could include: the development of pilot or feasibility projects, approaches for building a transdisciplinary research team, facilities or services to be provided on a continuing basis to the research project(s) or pilot studies.

Detailed Description of CCHR Center Components (1) The CCHRC must demonstrate the potential for a high degree of collaboration among investigators and across the research projects. (2) CCHRCs must be composed of linked research project(s) and Cores; however, the Cores are not intended to provide general infrastructure support to research programs.

(3) CCHRCs are expected to engage with the NIH Climate Change and Health Research Coordinating Center and be an active participant in the Community of Practice including attendance at annual recipient meetings and other community building and capacity building activities.

(1) The Center Director(s) should be a senior scientist with substantial research and scholarly experience in any of the following disciplines: climate science, exposure science, health effects (e.g., cardiovascular, respiratory, mental health, communicable diseases), bioinformatics and health information sciences, public health, medicine, nursing, epidemiology, toxicology, ecology, behavioral and social sciences (e.g., psychology, sociology, social work, anthropology, political science, economics, communication science), health disparities research, community-engaged research (including citizen science, community science, community-based participatory research), health communication science, dissemination and implementation science.

She/he/they must have a demonstrated ability to organize, administer, and direct the Center. (2) Leaders (PIs) of individual components must be established scientists in relevant fields. C.

Research Projects and Cores (1) Individual Research Project(s): Each project should demonstrate a significant contribution to the overall theme, be transdisciplinary in nature, and may include Adaptation Research, Basic and Mechanistic Research, Behavioral and Social Sciences Research, Data Integration, Disaster Research Response, Dissemination and Implementation Science, Epidemiology and Predictive Modeling, Exposure and Risk Assessment, and Systems Science.

(2) Each CCHRC must include an Administrative Core unit to provide oversight, coordination, and integration of Center activities. Plans must be outlined in the application within the Administrative Core for an external advisory board that will serve as an important source of guidance from experts in the field who do not have a vested interest in the Center or in the research to be conducted by the Center.

The Administrative Core description should also include a data infrastructure plan career development plans for any underrepresented biomedical researchers. (3) Each CCHRC must include a Community Engagement Core to partner with impacted communities or potential users of new tools and technologies to engage them in the research development, execution, and evaluation.

This core should develop, implement, and evaluate strategies to translate and apply the scientific findings of the Center into information for use by the public, policy makers, and clinical professionals. (4) Each CCHRC may include up to two additional cores to support capacity building activities.

These can include, but are not limited to: [TC([1] [TC([2] Pilot/feasibility studies to develop projects of limited scope to generate data needed to demonstrate technical feasibility. Enhancement of the research capabilities of center members, partners, and the broader community (e.g., new curricula, workshops, hands on experiences, etc.).

Techniques, services, or instrumentation that will enhance ongoing research efforts of more than one Research Project(s) or pilot/feasibility studies. Each P20 should be centered around a central theme that will provide new knowledge about how climate change impacts health and informs action-oriented solutions.

There should be a clear logical thread from the aims of each project that advances us toward solutions and interventions to health challenges posed by climate related threats. Examples of central theme areas that would be considered appropriate in response to this NOFO include, but are not limited to (see also, https://www. nih.

gov/sites/default/files/research-training/initiatives/climate-change/nih-climate-change-one-pager-updated.

pdf ): Integrate large-scale climate and health data into a data exploration interface including tools to explore climate and health links in these large datasets Engage transdisciplinary teams of geophysical and health scientists to explore the feasibility of innovative solutions-based approaches to address health impacts of climate change and health disparities Investigate the feasibility, acceptability, uptake and spread of interventions to promote preparedness and adaptation to anticipated health impacts of climate change at individual, community, regional, or national levels Explore co-benefits of interventions that mitigate the drivers of climate change and improve health (e.g., mitigating emissions of coal power plants), as well as identifying potential unintended consequences of these actions Examine changing risks from climate-related disasters and approaches to improve preparedness to protect the health of impacted community members, first responders, post-disaster volunteers, and field researchers Assess effects of climate change on health and population dynamics including fertility, mortality and morbidity, and population movement, distribution, and composition Identify climate-related vulnerabilities in nutritional security in disadvantaged communities to inform culturally sensitive and sustainable solutions Applications should include one or more scientific Project, each with a specific focus and linked together under the center’s theme with the overarching goal of informing action-oriented solutions.

At least one project should be a well-described hypothesis driven research project. Other CCHRC activities in the development core can include plans to develop the feasibility of future research or establish partnerships over the course of this development grant period in support of future research endeavors of the center.

Examples of project topics may include, but are not limited to: Proof of principle experiments to demonstrate the role of climate change-related exposures in disease etiology New methodologies to integrate multiple stressors into health risk assessments, including those exacerbated by climate change Adapt existing evidence-based interventions to promote resiliency in communities disproportionately impacted by climate change Communication science research on climate change-related environmental health literacy of key stakeholders including but not limited to community residents, healthcare/public health professionals, decision makers, and educators.

Develop new or adapt existing implementation strategies to promote the uptake of evidence-based interventions addressing climate change and human health Information Specific to the National Institute on Aging’s Interest The National Institute on Aging (NIA) is interested in understanding the biological, behavioral, and socioecological processes related to climate change and extreme weather that affect the health and wellbeing of older individuals, including those living with Alzheimer’s disease and Alzheimer’s disease related dementias (AD/ADRD), as examined in human and/or other animals.

Applicants are encouraged to consider innovative methods and research designs to facilitate studies within groups (e.g., racial/ethnic, urban/rural, veteran/non-veteran) as well as between groups, recognizing within-group heterogeneity that would be biological and/or contextual (e.g., individuals access to resources and lived experiences). Applicants should reference the NIA Health Disparities Research Framework .

Research topics of interest include, but are not limited to, the following: The impacts of climate change or extreme weather on health and/or well-being, rate of aging, and aging-related physiological processes, and functional abilities in humans or other animals across the life span. Other animals may include domestic, captive, or wild populations.

Physiological processes may include immune function, metabolism, circadian rhythms, etc. The contribution of extreme weather events and related natural disasters on biological processes and rates of aging in studies of domestic or wild animals.

Interactions or additive effects of environmental exposures or changing environmental hazards (e.g., particulates including heightened amounts of air pollutants, endocrine disrupters, residuals from manufacturing or other toxins, changes in pesticide or herbicide application practices, extreme heat or cold, disasters exacerbated by climate change) on molecular, cellular, toxicologic, and physiological perturbations that impact health and/or well-being across the lifespan as well as affective, social, behavioral, and cognitive functions (including brain health) over the life course.

Midlife and older adult health promotion, adaptation, recovery, and resilience in the face of climate change and in the aftermath of extreme weather events.

Effects of extreme weather events or changing environmental hazards on older adults, including those from different racial, ethnic, and sexual and gender minority groups, those living with disabilities, and those from socially disadvantaged backgrounds, effectively managing health conditions (e.g., diabetes, cholesterol, weight management, various types of arthritis, etc.) and financial burdens that may be exacerbated by changes in the environment (e.g. loss of livelihood during periods of extreme heat and drought or other extreme weather events).

The impact of age-related change in affective, social, and cognitive factors on individual responses to climate change, and on how individuals initiate and maintain the behavior changes needed for preparedness and adaptation to extreme weather events.

The contribution of extreme weather events and related natural disasters, to social structure and social adversity, and their effects on aging processes across the life course, in studies of animals in their natural habitats. Health services delivery and healthcare infrastructure preparedness in the context of climate change and extreme weather events.

Health care policies that may promote or sustain adopting preventive measures taken to mitigate overall rates of mortality or morbidity that are associated with, or caused by, extreme weather events or changing environmental hazards. Specifically, rates among older adults, including those from different racial, ethnic, and sexual and gender minority groups, those with disabilities, and those from socially disadvantaged backgrounds.

Cross-national analyses of nationally representative data, particularly analyses that include low- and middle-income countries, including data from the US Health and Retirement Study (HRS), International Family of HRS studies, and the Harmonized Cognitive Assessment Protocol (HCAP) available in the HRS and several international studies to measure cognitive outcomes.

Studies on organizational policies and practices for reducing healthcare facilities and systems emission contribution to climate change. Policy, economic, and systems analysis research towards system changes for preparedness or response to climate change and extreme weather events.

Studies that develop, implement, and evaluate the effectiveness of communication or educational resources about health impacts of climate change for older adult populations or stakeholders, including individuals living with AD/ADRD and individuals and institutions that provide care for these individuals. Plan for Enhancing Diverse Perspectives (PEDP) -NOFO instructions carefully and view the available PEDP guidance material.

NIH recognizes that diverse teams working together and capitalizing on innovative ideas and distinct perspectives outperform homogeneous teams.

There are many benefits that flow from a diverse scientific workforce, including: fostering scientific innovation, enhancing global competitiveness, contributing to robust learning environments, improving the quality of the research, advancing the likelihood that underserved populations participate in, and benefit from research, and enhancing public trust. To support the best science, NIH encourages inclusivity in research.

Examples of structures that promote diverse perspectives include but are not limited to: Transdisciplinary research projects and collaborations among researchers from fields such as computational biology, physics, engineering, mathematics, computer and data sciences, as well as bioethics Engagement from different types of institutions and organizations (e.g., research-intensive, undergraduate-focused, minority-serving, community-based).

Individual applications and partnerships that enhance geographic and regional heterogeneity. Investigators and teams composed of researchers at different career stages.

Participation of individuals from diverse backgrounds, including groups traditionally underrepresented in the biomedical, behavioral, and clinical research workforce (see NOT-OD-20-031 ), such as underrepresented racial and ethnic groups, those with disabilities, those from disadvantaged backgrounds, and women. Opportunities to enhance the research environment to benefit early- and mid-career investigators.

This NOFO requires a Plan for Enhancing Diverse Perspectives (PEDP) as part of the application (see further below). Applicants are strongly encouraged to read the NOFO instructions carefully and view the available PEDP guidance materials. Applications must include a Plan for Enhancing Diverse Perspectives (PEDP) submitted as Other Project Information as an attachment (see Section IV).

The PEDP will be assessed as part of the scientific and technical peer review evaluation. Applications Not Responsive to the NOFO: Projects that do not examine the actual or potential impacts of climate change on health-related outcomes Applications that do not include a Plan for Enhancing Diverse Perspectives (PEDP) Projects that include prohibited policy lobbying or advocacy activities (see https://grants. nih.

gov/grants/lobbying_guidance. htm for more information) The following link provides resources and partnership information for Climate Change and Health P-20 applicants to assist in developing robust and relevant research projects and core activities: https://www. niehs.

nih. gov/research/programs/climatechange/research_program/p20/ This list is meant to be suggestions only and applicants are encouraged to identify other partnerships. The NIH will hold an informational webinar/Q&A session April 5, from 1:00pm-3:00pm EDT on Zoom (Registration required at: https://nih.

zoomgov. com/webinar/register/WN__5Qj2le4SxqHg9QrCMkcew ). See Section VIII.

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

Award Information Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity. Application Types Allowed 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 NOFO.

Optional: Accepting applications that either propose or do not propose clinical trial(s). Need help determining whether you are doing a clinical trial? Funds Available and Anticipated Number of Awards NIH intends to commit $30 million in FY2023 and FY2024 to fund up to 17 awards.

Application budgets are limited to $850,000 direct costs per year and need to reflect the actual needs of the proposed project. The maximum project period is 3 years. NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this NOFO.

Section III.

Eligibility Information Higher Education Institutions Public/State Controlled Institutions of Higher Education Private Institutions of Higher Education The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education: Hispanic-serving Institutions Historically Black Colleges and Universities (HBCUs) Tribally Controlled Colleges and Universities (TCCUs) Alaska Native and Native Hawaiian Serving Institutions Asian American Native American Pacific Islander Serving Institutions (AANAPISIs) Nonprofits Other Than Institutions of Higher Education Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education) Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education) For-Profit Organizations (Other than Small Businesses) City or Township Governments Special District Governments Indian/Native American Tribal Governments (Federally Recognized) Indian/Native American Tribal Governments (Other than Federally Recognized) Eligible Agencies of the Federal Government U.S. Territory or Possession Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement , are allowed. Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award.

All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

System for Award Management (SAM) Applicants must complete and maintain an active registration, which requires renewal at least annually . The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.

NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM. Unique Entity Identifier (UEI) - A UEI is issued as part of the SAM. gov registration process.

The same UEI must be used for all registrations, as well as on the grant application. eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants. gov registration; all registrations must be in place by time of submission.

eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application. Grants. gov Applicants must have an active SAM registration in order to complete the Grants.

gov registration. Program Directors/Principal Investigators (PD(s)/PI(s)) All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons.

If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Eligible Individuals (Program Director/Principal Investigator) Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support.

Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019 .

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide. This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement . 3.

Additional Information on Eligibility Applicant organizations may submit more than one application, provided that each application is scientifically distinct. The NIH will not accept duplicate or highly overlapping applications under review at the same time, per 2. 3.

7. 4 Submission of Resubmission Application . This means that the NIH