Part 1. Overview Information

Key Dates

No late applications will be accepted for this Notice of Funding Opportunity.

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 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

Purpose

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).

Background

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

Research Objectives

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

A. Overall Center

(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.

B. The Investigators

(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.

Central Theme Areas

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

Research Project Topics

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

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

1. Eligible Applicants

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

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Local Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)

Federal Governments

• 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

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.

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.

2. Cost Sharing

This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement.

3. Additional Information on Eligibility

Number of Applications

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 will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

Section IV. Application and Submission Information

1. Requesting an Application Package

The application forms package specific to this opportunity must be accessed through ASSIST or an institutional system-to-system solution. A button to apply using ASSIST is available in Part 1 of this NOFO. See the administrative office for instructions if planning to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the Multi-Project (M) Instructions in the SF424 (R&R) Application Guide, except where instructed in this notice of funding opportunity to do otherwise and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. 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.

Letter of Intent

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

• Descriptive title of proposed activity
• Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity

The letter of intent should be sent to:

Linda K. Bass, PhD
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 984-287-3236
Email: bass@nih.gov

Page Limitations

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

Instructions for the Submission of Multi-Component Applications

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing a multi-component application.

The application should consist of the following components:

• Overall: required
• Administrative Core: required, 1 maximum
• Research Project(s)s: required, minimum of 1 maximum of 2
• Community Engagement Core: required, 1 maximum
• Core(s): optional, 2 maximum

Overall Component

When preparing the application, use Component Type Overall .

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

SF424(R&R) Cover (Overall)

Complete entire form.

PHS 398 Cover Page Supplement (Overall)

Note: Human Embryonic Stem Cell lines from other components should be repeated in cell line table in Overall component.

Research & Related Other Project Information (Overall)

Follow standard instructions.

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Other Attachments:

The filename provided for the attachment will be the name used for the bookmark in the application image. There is one Other Attachments that is required. Applications that do not include this attachment will be considered non-responsive and withdrawn.

Plan for Enhancing Diverse Perspectives (PEDP) (use file name: PEDP)

In an "Other Attachment" entitled "Plan for Enhancing Diverse Perspectives," all applicants must include a summary of strategies to advance the scientific and technical merit of the proposed project through expanded inclusivity. The PEDP should provide a holistic and integrated view of how enhancing diverse perspectives is viewed and supported throughout the application and can incorporate elements with relevance to any review criteria (significance, investigator(s), innovation, approach, and environment) as appropriate. Where possible, applicant(s) should align their description with these required elements within the research strategy section. The PEDP will vary depending on the scientific aims, expertise required, the environment and performance site(s), as well as how the project aims are structured. The PEDP may be no more than 1-page in length and should include a timeline and milestones for relevant components that will be considered as part of the review. Examples of items that advance inclusivity in research and may be part of the PEDP can include, but are not limited to:

• Discussion of engagement with different types of institutions and organizations (e.g., research-intensive, undergraduate-focused, minority-serving, community-based).
• Description of any planned partnerships that may enhance geographic and regional diversity.
• Plan to enhance recruiting of women and individuals from groups traditionally underrepresented in the biomedical, behavioral, and clinical research workforce.
• Proposed monitoring activities to identify and measure PEDP progress benchmarks.
• Plan to utilize the project infrastructure (i.e., research and structure) to support career-enhancing research opportunities for diverse junior, early- and mid-career researchers.
• Description of any training and/or mentoring opportunities available to encourage participation of students, postdoctoral researchers, and co-investigators from diverse backgrounds.
• Plan to develop transdisciplinary collaboration(s) that require unique expertise and/or solicit diverse perspectives to address research question(s).
• Publication plan that enumerates planned manuscripts and proposed lead authorship.
• Outreach and planned engagement activities to enhance recruitment of individuals from diverse backgrounds as research participants including those from underrepresented groups.

Applicants are strongly encouraged to read the NOFO instructions carefully and view the available PEDP guidance material https://braininitiative.nih.gov/about/plan-enhancing-diverse-perspectives-pedp.

Project/Performance Site Locations (Overall)

Enter primary site only.

List all performance sites that apply to the specific component.

A summary of Project/Performance Sites in the Overall section of the assembled application image in eRA Commons compiled from data collected in the other components will be generated upon submission.

Research and Related Senior/Key Person Profile (Overall)

Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this NOFO) for the entire application.

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Project Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

A summary of Senior/Key Persons followed by their Biographical Sketches in the Overall section of the assembled application image in eRA Commons will be generated upon submission.

Budget (Overall)

The only budget information included in the Overall component is the Estimated Project Funding section of the SF424 (R&R) Cover.

A budget summary in the Overall section of the assembled application image in eRA Commons compiled from detailed budget data collected in the other components will be generated upon submission.

PHS 398 Research Plan (Overall)

Introduction to Application: For Revision applications, an Introduction to Application is required in the Overall component.

Specific Aims: The specific aims for the CCHRC should describe the theme and goals to be accomplished.

Research Strategy:

Describe the scientific rationale underpinning the theme of this CCHRC, the institutional need for a developmental center grant to build research capacity, and how the Center will provide new knowledge about how climate change impacts health and advance the field towards solutions-oriented adaptation and implementation. The theme may be broad or focused, depending upon the goals of the CCHRC.

Describe the unique contributions or the significant gap in climate change and health research the CCHRC will address and which core elements of the NIH Climate Change and Health Initiative Strategic Framework the CCHRC will support.

Describe the strategy by which the goals of the CCHRC will be met.

Describe the overall structure of the CCHRC and plan for coordination among the Administrative Core, the Development Core, the Community Engagement Core, Research Project(s), and any Facilities or Service Cores.

Provide a justification for each component in terms of the overall goals of the CCHRC.

State how CCHRC resources will provide a unique contribution to the research infrastructure at the institution.

Letters of Support: Overall letters of support should be obtained from individuals and institutions providing resources to the CCHRC. Letters from the Institution and any named External Advisory Committee members must be included. The letter of support from the Institution should include the commitment to continuing support of the CCHRC in the event of a change in Directorship.

Resource Sharing Plan:
Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.

Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.

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 application forms packages. If required, the Data Management and Sharing (DMS) Plan must be provided in the Overall component.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

• 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.

Appendix:

Only 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 (Overall)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials 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, there must be 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 within the application. The study record(s) must be included in the component(s) where the work is being done, unless the same study spans multiple components. To avoid the creation of duplicate study records, a single study record with sufficient information for all involved components must be included in the Overall component when the same study spans multiple components.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the SF424 (R&R) Application Guide must be followed.

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 (Overall)

All instructions in the SF424 (R&R) Application Guide must be followed.

Administrative Core

When preparing your application, use Component Type Administrative Core.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

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 application forms packages. If required, the Data Management and Sharing (DMS) Plan must be provided in the Overall component.

SF424 (R&R) Cover (Administrative Core)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Administrative Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Administrative Core)

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Administrative Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Administrative Core)

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Project Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Administrative Core)

Budget forms appropriate for the specific component will be included in the application package.

Annual RCC for Climate and Health Meetings: Each CCHRC must allocate funds to cover travel expenses for at least 3 center members to attend the annual meeting held by the NIH Research Coordinating Center to Support Climate Change and Health Community of Practice. The CCHRC Director is expected to attend, and junior investigators are especially encouraged to attend.

Applicants may include allowable costs associated with PEDP implementation (as outlined in the Grants Policy Statement section 7: https://grants.nih.gov/grants/policy/nihgps/html5/section_7/7.1_general.htm).

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Administrative Core)

Specific Aims: Clearly state how the Administrative Core will contribute to the goals of the CCHRC and outline interactions of the Administrative Core with each of the other Cores. Provide an overview of how the Administrative Core will set the overall direction of the Center and ensure optimal utilization of Center resources.

Research Strategy:

The Administrative Core plays a key role in the coordination and functioning of the CCHRC. Therefore, it should manage the overall activities of the Center, including developing, promoting, and managing use of Center resources.

The Administrative Core must contain the following:

• A general description of activities and institutional support of the CCHRC.
• A presentation of the administrative structure. Include the role of the Administrative Core in 1) establishing and maintaining all collaborations, and 2) ensuring that the research complies with appropriate regulations and guidelines.
• A description of how the Administrative Core will ensure the synthesis of findings and activities from research projects and cores towards solutions-oriented translation of findings in support of the CCHRC theme and the NIH Climate and Health Initiative.
• A process must be in place, and should be described in the application, that would be used to recommend a successor to the Director, if needed.

The Administrative Core must describe how they will meet their responsibilities to:

• Review utilization of funds, including funds for pilot projects and other CCHRC activities, and assure the appropriate expenditure of funds.
• Optimize the utilization of the shared resources of the CCHRC, such as all Core resources.
• Develop and execute a Center evaluation plan that includes ongoing evaluation of all Center activities.

The organization of the Administrative Core must encompass a supportive structure sufficient to accomplish the following:

• Coordinate and integrate the CCHRC components and activities.
• Review the utilization and quality of Core resources.
• Review utilization of funds, including funds for pilot projects and other Core(s) activities, and assure the appropriate expenditure of these funds.
• Plan for the sustainability of the CCHRC after the period of support is completed, including development of collaboration(s) and preparation for seeking NIH R-series (R21, R01) and P series (P30) support as well as support from other federal or private research funding.
• Oversight of the External Advisory Committee (EAC). The EAC should meet in person at least once annually. Each EAC meeting will have an appointed Chair.
• The minutes of the meeting of the EAC, as well as a response from the CCHRC PD/PI concerning EAC meeting recommendations, must be submitted to the NIH Program Officer within 30 calendar days of the EAC meeting.

In addition, the Research Strategy for the Administrative Core should:

• Describe the data infrastructure and management plan.

Letters of Support: Letters of support should be obtained from those providing resources to the administrative core.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

Appendix:

Only 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.

Project

When preparing your application, use Component Type Project.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

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 application forms packages. If required, the Data Management and Sharing (DMS) Plan must be provided in the Overall component.

SF424 (R&R) Cover (Project)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Project)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Project)

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Project)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Project)

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Project Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Project)

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Project)

Specific Aims: State the hypothesis and describe the specific aims for a research project. Projects should be tied to the overall central theme of the CCHRC.

Research Strategy:

• Describe how this research project relates to the overall theme of the CCHRC and will contribute to the development of action-oriented strategies that protect health.
• Include any preliminary data (if available).
• Describe the study design and experimental methods.
• Identify students, post-doctoral fellows, or ESIs involved in the project.

Letters of Support: Letters of support should be obtained for each specific research project.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

Generally, Resource Sharing Plans are expected, but they are not applicable for this NOFO.

Appendix:

Only 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 (Project)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials 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

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.

Community Engagement Core

When preparing your application, use Component Type Community Engagement Core.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

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 application forms packages. If required, the Data Management and Sharing (DMS) Plan must be provided in the Overall component.

SF424 (R&R) Cover (Community Engagement Core)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Community Engagement Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Community Engagement Core)

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Community Engagement Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Community Engagement Core)

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Project Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Community Engagement Core)

Budget forms appropriate for the specific component will be included in the application package.

Applications should devote a minimum of 15% of direct costs annually to the CEC.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Community Engagement Core)

Specific Aims: The Community Engagement Core (CEC) promotes multi-directional communication among the CCHRC and its identified audience(s) on issues of climate change and health. The CEC ensures responsiveness and relevance to community needs through collaborative efforts that foster dialogue and interactions among the identified audience and Center members. While CECs may choose to align their vision and goals to the principles of community-based participatory research (CBPR), the CECs are not required to conduct CBPR. State the specific aims of the CEC and include anticipated impacts for these aims.

Research Strategy: Describe the CEC’s vision, objective, and plans to:

• Translate and disseminate CCHRC research results into climate change and health knowledge for identified audience(s).
• Communicate audience issues, needs, and concerns to CCHRC members to inform and guide the development of appropriate research activities that address the expressed needs of the identified audience(s).
• Establish new partnerships with communities impacted by the CCHRC’s climate and health research
• Advance scientific literacy in climate and health. In this context, CECs may use social science/communication research approaches to examine the impacts and outcomes of their work.
• Describe how the stated objectives, activities, and products are aligned with the central theme of the CCHRC. In addition, explain how objectives, activities, and products are appropriate to the needs of the identified audience.
• Describe CEC plans for evaluating the impact of these activities.

Letters of Support: Letters of support should be provided where appropriate to demonstrate collaboration, access to resources, institutional commitment, etc.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

Generally, Resource Sharing Plans are expected, but they are not applicable for this NOFO.

Appendix:

Only 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 (Community Engagement Core)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials 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

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.

Core

When preparing your application, use Component Type Core.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

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 application forms packages. If required, the Data Management and Sharing (DMS) Plan must be provided in the Overall component.

SF424 (R&R) Cover (Development Core)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Core)

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Core)

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Project Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Core)

Budget forms appropriate for the specific component will be included in the application package.

Pilot project funds cannot be used to supplement research that has already been funded, regardless of the source.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Core)

Specific Aims: Describe the specific aims for the each Core tied to the overall central theme of the CCHRC and describe the activities to be included in the Core.

Research Strategy:

Please describe how the stated objectives, activities, and products of the Core are aligned with the central theme of the CCHRC and how the Core will perform its functions. Examples include, but are not limited to:

Administer Pilot Projects: Describe how the CCHRC will prepare and ensure appropriate distribution of announcements of the availability of pilot/feasibility project funding to potential applicants, coordinate the scientific merit review of pilot proposals, maintain oversight and review of progress for ongoing pilot studies, keep appropriate records for all pilot projects with Human Subjects, and guide the development of pilot/feasibility studies into future funding opportunities.

Build research capacity: Provide details on the special talents and resources that will be drawn to and built upon at the CCHRC. Include a plan for bringing investigators into the CCHRC from within and outside the area of environmental health sciences and needed expertise. Describe academic and research partnerships that will be pursued by the CCHRC to advance its goals and missions and promote diversity in the climate research community of practice. Describe plans to develop training materials and opportunities for CCHRC members to develop their research skills and ability to translate findings to facilitate understanding of and adaptation to the growing threat of climate change on health.

Provide a facility or service: The application should explain the organization and proposed mode of operation of the proposed core. Examples include, but are not limited to animal use and transgenic models, imaging, tissue culture, pathology support, biostatistics and statistical support, oligonucleotide synthesis, analytical chemistry, proteomics, bioinformatics, exposure assessment, and handling of human tissue specimens. The facility or service should be unique and not duplicate services or facilities that already exist at the parent or collaborating institutions or can be purchased commercially

Letters of Support: Letters of support should be obtained from consultants and pilot project reviewers who will be providing services to the Core.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

Generally, Resource Sharing Plans are expected, but they are not applicable for this NOFO.

Appendix:

Only 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 (Core)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials 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

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.

Foreign Institutions

Foreign (non-U.S.) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.

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.

For information on how applications will be automatically assembled for review and funding consideration after submission, refer to: http://grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multi-project_Application_Image_Assembly.pdf.

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) and component Project Leads must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile form. 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 unique entity identifier provided on the application is the same identifier used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.

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.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Applications must include a PEDP submitted as Other Project Information as an attachment. Applications that fail to include a PEDP will be considered incomplete and will be withdrawn.

In order to expedite review, applicants are requested to notify the NIEHS Referral Office by email at bass@nih.gov when the application has been submitted. Please include the NOFO number and title, PD/PI name, and title of the application.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in the policy.

Section V. Application Review Information

1. Criteria

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.

A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

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. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Does the CCHRC central theme address a critical gap in knowledge or feasibility of adaptation approaches for climate change impacts on health?

To what extent do the efforts described in the PEDP further the significance of the project?

In addition, for applications involving clinical trials

Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy? For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Specific for this NOFO:

Do the CCHRC Director and Core leaders demonstrate the ability to provide scientific and administrative leadership and direction? Is the Deputy Director qualified to serve in the absence of the Director? Do the named investigators have the qualifications/background to assist in the CCHRC efforts towards implementing the vision of the CCHRC?

Is there an appropriate transdisciplinary team? If the proposed research will be conducted in a community anticipated to be disproportionately impacted by climate change, are members of the community and/or institutions that serve that community included as partners in the research?

To what extent will the efforts described in the PEDP strengthen and enhance the expertise required for the project?

In addition, for applications involving clinical trials

With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Specific for this NOFO:

Is an innovative transdisciplinary approach proposed to address novel questions about the health impact of, or adaption to, climate change?

To what extent will the efforts described in the PEDP meaningfully contribute to innovation?

In addition, for applications involving clinical trials

Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address:

1) the protection of human subjects from research risks, and
2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

Specific for this NOFO:

Will the structure of the CCHRC likely facilitate translational of research towards action-oriented strategies that protect health and build resiliency at the individual, community, national and global levels? Will the plans, as proposed, attract investigators to the CCHRC from within and outside the health sciences?

Is there a solid rationale and conceptual framework to demonstrate the feasibility of the approach? Do the investigators propose at least one hypothesis-driven research project and plans for developing additional pilot/feasibility studies and building research capacity?

Does the CCHRC propose approaches that engage the target community/ies? If so, is there evidence of established research collaborations with proposed community partners? How feasible and appropriate are the plans for integrating community partners into the CCHRC research? If applicable, is the plan to report research results to study participants adequate and appropriate?

Are the timeline and milestones associated with the PEDP well-developed and feasible?

In addition, for applications involving clinical trials

Does the application adequately address the following, if applicable

Study Design

Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?

Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?

Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?

Data Management and Statistical Analysis

Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

Specific for this NOFO:

Does the CCHRC demonstrate that it includes the skills, technologies, and capacity to foster interdisciplinary, state-of-the-art, and innovative research to advance its central theme as proposed in the application? Does the proposed CCHRC have a sufficient base of funded research directly relevant to the central theme? Does the CCHRC take advantage of the capability of its research base to maximize scientific productivity, particularly through transdisciplinary coordination and collaboration?

Is the level of institutional commitment appropriate and demonstrative of significant support to the CCHRC? Is the scientific environment appropriate and conducive towards the translational efforts proposed in the CCHRC?

To what extent will features of the environment described in the PEDP (e.g., collaborative arrangements, geographic diversity, institutional support) contribute to the success of the project?

In addition, for applications involving clinical trials

If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?

Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?

If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?

If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?

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.

Study Timeline

Specific to applications involving clinical trials

Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate?

Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?

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 of all ages (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 Animals 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

Not Applicable

Renewals

Not Applicable

Revisions

Not Applicable

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

Applications from Foreign Organizations

Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

Reviewers will comment on whether the Resource Sharing Plan(s) (e.g., Sharing Model Organisms) or the rationale for not sharing the resources, is reasonable.

Authentication of Key Biological and/or Chemical Resources:

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

Additional Review Criteria - Cores

For component types: Admin Core and Core [use for: Community Engagement Core, and other Core(s)] reviewers will consider the following review criteria in assessing and providing a score to each core/project:

Administrative Core

Are the objectives of the Administrative Core appropriate to the CCHRC? Are the approaches and methods proposed adequate to achieve objectives?

Do the Administrative Core objectives reflect the transdisciplinary nature of the CCHRC? Are interactions among projects, cores, and external partners/communities evident? Does the CCHRC’s internal plan promote coordination of transdisciplinary research and stimulate collaborations among components, particularly regarding project interactions? Is there evidence of an internal plan to promote integration and coordination?

Is there evidence that the lines of authority and the administrative structure are designed for effective management and leadership of the Center? Does the senior leadership have appropriate experience, and have they demonstrated effective and responsible leadership in the past?

Is there a decision-making process for the management of funds and resources? Is there evidence of an ability to provide administrative support to the project and core leaders?

Is there an appropriate plan to establish and use an external advisory committee with appropriate expertise? For the activities proposed, is the percent effort requested adequate? Are the qualifications, duties, and time commitments of administrative staff appropriate to contribute to the needs and conduct of the CCHRC&##146;s research activities? Is the institutional commitment adequate? Is there evidence of support or cooperation between multiple institutional departments, as applicable?

Is the role of the Co-Director appropriate for the Administrative Core and does their expertise contribute to the Center?

Is there a plan to ensure Center compliance with the overall and individual component resource and data sharing plans?

Is the data infrastructure and management plan robust and adequate for the proposed activities?

a commitment to diversity, equity and inclusion?

Community Engagement Core

Is the CEC a logical outgrowth of the CCHRC theme?

Will the CEC lead to a mutually beneficial, multi-directional relationship between the academic institution and the identified audience(s)? Are the problems they plan to address aligned to the CCHRC?

Are objectives for CEC clear and measurable? Are evaluation plans defined to measure the impact of core activities? If so, are the evaluation plans appropriate?

Are outreach and educational engagement programs proposed to increase awareness and understanding of climate and health research being conducted at the CCHRC? For the products being proposed, are they relevant to the theme of the CCHRC and to the needs of the identified audience?

With respect to the CEC's defined audience, are the plans, activities, and coordination for the proposed CEC, appropriate?

Is there adequate integration of the CEC into the CCHRC and its proposed activities?

Do the plans adequately describe a process for maintaining transparent communications between the identified audience and the academic partners throughout the entire process of the activity?

Does the CEC investigator provide previous experience/evidence for conducting community engagement activities?

Core (if applicable)

How feasible and practical are the CCHRC plans to review and distribute funds for pilot/feasibility studies?

Does the CCHRC plan to use pilot funds in a manner that encourages innovative ideas of importance to environmental health sciences?

Will the CCHRC use pilot/feasibility studies to fill gaps in research areas relevant to the central theme of the CCHRC?

Are the CCHRC’s plans building research capacity adequate and aligned with the central theme?

Are the objectives of the provided facility or service appropriate to the Center? Are the approaches and methods proposed adequate to achieve objectives?

Does the facility or service core promote and/or enhance interactions among the CCHRC components? Does the core provide essential facilities or service for two or more of the components? Is the projected use sufficient to warrant establishment of the Core?

Are the facility or service core resources contributing to the overall research activities of the CCHRC? Is there evidence of enhanced efficiencies (including cost) afforded by the facility or service core?

Does the facility or service core staff have the appropriate experience and level of commitment?

Does the facility or service core contribute scientifically to the central theme of the CCHRC?

Additional Review Criteria Project(s)

Significance

Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Does the project proposal address a critical gap in knowledge or feasibility of adaptation approaches for climate change impacts on health?

Does the Project contribute scientifically to the central theme of the CCHRC?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance, and organizational structure appropriate for the project?

Is there an appropriate transdisciplinary project team? If the proposed research will be conducted in a community anticipated to be disproportionately impacted by climate change, are members of the community and/or institutions that serve that community included as partners in the research?

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Is an innovative transdisciplinary research approach proposed to address novel questions about the health impact of, or adaption to, climate change?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility, and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

Is there a solid rationale and conceptual framework to demonstrate the feasibility of the approach?

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment, and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

Additional Review Criteria -Projects

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.

Those Projects with a Community-Engaged Research component

If the Research Project includes community engaged research as an aspect of the Project, then the following criteria will be included in the evaluation.

Are the CCHRC’s activities appropriate to the needs of the community involved? Are the partners involved in other aspects of the CCHRC? Does a productive working relationship exist between CCHRC investigators and community members? Will information be adequately disseminated?

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by NIEHS, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications will receive a written critique.

Applications may undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.

Appeals of initial peer review will not be accepted for applications submitted in response to this NOFO

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this NOFO. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

Section VI. Award Administration Information

1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the recipient's business official.

Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this NOFO will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.

Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.

ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain applicable clinical trials on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration and results reporting of all trials whether required under the law or not. For more information, see https://grants.nih.gov/policy/clinical-trials/reporting/index.htm

Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).

Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).

Prior Approval of Pilot Projects

Recipient-selected projects that involve {clinical trials or studies involving greater than minimal risk to human subjects} require prior approval by NIH prior to initiation.

• The recipient institution will comply with the NIH Guidance on Changes That Involve Human Subjects in Active Awards and That Will Require Prior NIH Approval.
• The recipient institution will provide NIH with specific plans for data and safety monitoring, and will notify the IRB and NIH of serious adverse events and unanticipated problems, consistent with NIH DSMP policies.

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities, including of note, but not limited to:

• Federal wide Research Terms and Conditions
• Prohibition on Certain Telecommunications and Video Surveillance Services or Equipment
• Acknowledgment of Federal Funding

If a recipient is successful and receives a Notice of Award, in accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

Should the applicant organization successfully compete for an award, recipients of federal financial assistance (FFA) from HHS will be required to complete an HHS Assurance of Compliance form (HHS 690) in which the recipient agrees, as a condition of receiving the grant, to administer programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, age, sex and disability, and agreeing to comply with federal conscience laws, where applicable. This includes ensuring that entities take meaningful steps to provide meaningful access to persons with limited English proficiency; and ensuring effective communication with persons with disabilities. Where applicable, Title XI and Section 1557 prohibit discrimination on the basis of sexual orientation, and gender identity, The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. See https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html.

HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this NOFO.

• For guidance on meeting the legal obligation to take reasonable steps to ensure meaningful access to programs or activities by limited English proficient individuals see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.htmlandhttps://www.lep.gov.

• For information on an institution’s specific legal obligations for serving qualified individuals with disabilities, including providing program access, reasonable modifications, and to provide effective communication, see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html.

• HHS funded health and education programs must be administered in an environment free of sexual harassment, see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html. For information about NIH's commitment to supporting a safe and respectful work environment, who to contact with questions or concerns, and what NIH's expectations are for institutions and the individuals supported on NIH-funded awards, please see https://grants.nih.gov/grants/policy/harassment.htm.

• For guidance on administering programs in compliance with applicable federal religious nondiscrimination laws and applicable federal conscience protection and associated anti-discrimination laws see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/index.html.

Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 and 2 CFR Part 200.206 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.

Not Applicable

3. Data Management and Sharing

Note: The NIH Policy for Data Management and Sharing is effective for due dates on or after January 25, 2023.

Consistent with the NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.

When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

Progress reports should briefly describe status of pilot projects, including data and safety monitoring, and should notify NIH of serious adverse events and unanticipated problems.

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement. NIH NOFOs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 45 CFR Part 75.301 and 2 CFR Part 200.301.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All recipients of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over the threshold. See the NIH Grants Policy Statement for additional information on this reporting requirement.

In accordance with the regulatory requirements provided at 45 CFR 75.113 and 2 CFR Part 200.113 and Appendix XII to 45 CFR Part 75 and 2 CFR Part 200, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 and 2 CFR Part 200 Award Term and Condition for Recipient Integrity and Performance Matters.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

Finding Help Online: https://www.era.nih.gov/need-help (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-637-3015

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov

Emerald T. Nguyen, Ph.D.
National Institute on Aging (NIA)
Division of Behavioral and Social Research (BSR)
Telephone: 301-496-3136
Email: Emerald.nguyen@mail.nih.gov

Abee Boyles, PhD
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 984-287-3241
Email: abee.boyles@nih.gov

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

Megan Kinnane, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-443-3679
Email: megan.kinnane@nih.gov

Adriana Costero-Saint Denis, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-292-4184
Email: acostero@niaid.nih.gov

B. Fenton Hall, M.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-627-3268
E-mail: lhall@niaid.nih.gov

Flora N Katz
FIC - FOGARTY INTERNATIONAL CENTER
Phone: 301-402-9591
E-mail: katzf@mail.nih.gov

Arielle S. Gillman, PhD, MPH
National Institute on Minority Health and Health Disparities (NIMHD)
Phone: 301-402-1366
E-mail: arielle.gillman@nih.gov

David A. Jett, Ph.D.
National Institute of Neurological Disorder and Stroke (NINDS)
Telephone: 301-496-6035
Email: jettd@ninds.nih.gov

Liz Perruccio, MS, PhD
National Institute of Nursing Research (NINR)
Telephone: 301-402-8084
Email: liz.perruccio@nih.gov

Elizabeth A. Vogt, MPH
Office of Disease Prevention
Phone: (301) 827-5576
E-mail: elizabeth.vogt@nih.gov

Lawrence Fine, PhD
National Heart, Lung and Blood Institute (NHLBI)
Telephone: 301-435-0305
Email: finel@nhlbi.nih.gov

Kara L. Hall, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-6831
Email: hallka@mail.nih.gov

Linda K. Bass, PhD
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 984-287-3236
Email: bass@nih.gov

Ryan Blakeney
National Institute on Aging (NIA)
Phone: 301-451-9802
E-mail: blakeneyr@mail.nih.gov

Jenny L. Greer
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 984-287-3332
Email: jenny.greer@nih.gov

Margaret Young
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-642-4552
Email: margaret.young@nih.gov

Robert Munk
National Institute of Mental Health (NIMH)
National Institute of Neurological Disorders and Stroke (NINDS )
Telephone:301-443-3034
Email: rmunk@mail.nih.gov

Lindsey Freeman
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-761-6799
E-mail: lindsey.freeman@nih.gov

Victoria Quach Tran
FIC - FOGARTY INTERNATIONAL CENTER
Phone: none
E-mail: vicky.tran@nih.gov

Priscilla Grant, JD
National Institute on Minority Health and Health Disparities (NIMHD)
Phone: 301-594-8412
E-mail: pg38h@nih.gov

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

Ron Wertz
National Institute of Nursing Research (NINR)
Telephone: 301-594-2807
Email: wertzr@mail.nih.gov

Tyrone Smith
National Heart, Lung and Blood Institute (NHLBI)
Telephone: 301-827-8053
Email: smithty@nhlbi.nih.gov

Crystal Wolfrey
National Cancer Institute (NCI)
Telephone: 240-276-6277
Email: wolfreyc@mail.nih.gov

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75 and 2 CFR Part 200.