Part 1. Overview Information

Key Dates

All applications are due by 5:00 PM local time of applicant organization. 

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide, except where instructed to do otherwise (in this NOFO or in a Notice from 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

Background

The exposome is defined as the totality of exposures to which an individual is subjected from conception to death. The exposome describes all exposures throughout an individual’s entire lifespan (e.g., physical and chemical agents, lifestyle factors, socioeconomic conditions, natural and built environments) and the biochemical and functional changes triggered by those exposures as a reflection of the cumulative burden of chronic stress and life events. Therefore, the study of the exposome (i.e., exposomics) provides a framework for discovery of novel exposure-disease associations through simultaneous examination of multiple environmental factors and their associated biological changes. More importantly, when combined with genetic studies, exposome research provides opportunities for better understanding the role of complex gene environment interplay in the etiology, treatment, and prevention of complex diseases such as cancer, Alzheimer’s, type 2 diabetes, asthma, and cardiovascular disease. Precision environmental health is an emerging concept that seeks to develop precise and effective disease prevention and intervention strategies by understanding risk at the individual level. Operationalizing exposomics and identifying key environmental factors and interactions that impact health and disease is a major step toward fulfilling the promise of precision environmental health.  

The study of the exposome has led to a paradigm shift in environmental health research in the past decade that was evidenced by major investments in exposome research around the world. These include the exposome projects funded under the European Union FP7 Exposome Program (HELIX, EXPOsOMICS, HEALS), the Japan Environment and Children’s Study (JECS), the establishment of Children’s Health Exposure Analysis Resource (CHEAR) and Human Health Exposure Analysis Resource (HHEAR) by NIEHS, and the formation of the European Human Exposome Network (EHEN) funded under Horizon 2020. Additionally, large NIH-supported initiatives are embracing the exposome concept to capture both environmental and genetic contributions in health and disease. With increased recognition and adoption of the exposome concept by the national and international biomedical research community, there is a critical need for global coordination and cooperation to build off ongoing exposomics efforts and capitalize on technological innovations in various disciplines and existing resources, in a manner similar to the highly collaborative international effort that was critical for achieving success of the Human Genome Project.

At the recent NIEHS workshop series entitled “Accelerating Precision Environmental Health: Demonstrating the Value of the Exposome”, a wide range of opportunities and research gaps were identified in various areas of exposome research, including methods standardization and scale-up, geospatial mapping of the exposome, creating interoperable data repositories, using AI/ML for data integration and analysis, and applying exposomics to understand health effects at both individual and community levels especially for addressing health disparity in marginalized communities. Moreover, the workshop series highlighted the critical need of a Community of Practice (CoP) to develop guiding principles, promote best practices in exposomics, and coordinate efforts across disciplines as the field moves forward. Additionally, the European Commission is establishing “Global Coordination of Exposome Research” under 2023-24 Horizon Europe, which calls for 1) Proposal for a commonly agreed conceptual framework for the exposome; 2) Proposal for options for a global governance structure for a Global Human Exposome Network; 3) Agreed upon technologies needed to decipher the exposome, and more. It specifically calls out the importance of leveraging ongoing related activities in the U.S. (e.g., activities supported by the National Institute of Environmental Health Sciences) in global cooperation.

This NOFO is to build upon the effort that is supported by the European Union to further extend, expedite, and coordinate exposome research efforts on a global scale. In particular, this NOFO will promote methods standardization, harmonization and best practices in operationalizing exposomics in the U.S. and around the world. This needs to be achieved by working with existing exposome research initiatives, infrastructures, and resources. The NOFO also emphasizes the importance of supporting diverse perspectives in the exposomics community through methods and resource sharing, education and capacity building, and transdisciplinary collaborations.

Objectives

The Center for Exposome Research Coordination (CERC) will engage various groups and communities that are relevant to better operationalize exposomics and accelerate precision environmental health. The CERC is expected to work with the exposome research community and international partners (including the European Global Coordination of Exposome Research) in the following areas:

• Develop and disseminate a commonly agreed upon framework for exposomics, by collaborating with the European Global Exposome Research Coordination and with input from the broader biomedical research community. The framework should address fundamental questions that include but are not limited to:
  • What are the measurable elements of the exposome in human studies based on the state of science (i.e., what should and can be measured)?
  • What is the role of animal models and in vitro systems in advancing exposomics?
  • What are the essential technologies/methodologies for conducting exposomics?
  • What are the data standards and data infrastructure needs for supporting exposomics?
  • How can exposomics be applied to address health issues at both community and individual levels?
• Create a centralized online resource of methods and tools to support ongoing and future exposome initiatives in the U.S. and potentially for international cooperation. The CERC should hold workshops and consensus meetings to work on relevant issues by engaging and leveraging ongoing efforts and existing resources such as Environmental influences on Child Health Outcomes (ECHO), Multi-Omics for Health and Disease initiative, NIEHS data and metadata standards initiative, HHEAR, the Environmental Health Language Collaborative (EHLC), other relevant programs supported by participating ICs, and EHEN. Activities include but are not limited to:
  • Identifying, cataloguing, and broadly disseminating existing and commonly used methods, technologies, and resources (e.g., geospatial models and databases, wearable sensors, methods for assessing biomarkers of exposure and associated biological changes, omics approaches, multi-omics integration, AI/ML, etc.).
  • Promoting standardization, harmonization, and/or best practices in exposome data collection, reporting, sharing, and analysis.
  • Promoting the development and creation of reference standards and quality control materials that are specific for exposomics analysis to facilitate cross study data harmonization and integration.
  • Organizing round-robin activities to improve inter- and intra-laboratory comparability of commonly used methods.
  • Disseminating methods and best practices to the broad biomedical research community.
  • Identify future needs in technology/methodology for data collection, analysis, and data interpretation.
•  Build a global exposome community supported by diverse perspectives, educate future scientists, and foster transdisciplinary collaborations. Activities include but are not limited to:
  • Developing a governance structure for a Global Human Exposome Network and establishing communications by working with partners of diverse perspectives around the world, taking advantage of and connecting to existing exposome research initiatives and infrastructures.
  • Promoting exposome education and building research capacity across the broad biomedical research community especially in under-resourced communities and low- and middle-income countries (e.g., develop educational materials and short courses, hold workshops and webinars, etc.)
  • Identifying opportunities for incorporating exposome into existing and ongoing health research efforts, including combined analysis across different cohorts and studies, examination of gene-environment interactions using large datasets (e.g., nationwide biobanks), and utilization of existing biospecimens to expand biomarker data collection.
  • Conducting or supporting pilot studies for proof of concept or preliminary data collection for larger collaborative efforts.

National Institute of Aging (NIA) Interests:

The NIA is interested in accelerating exposome-related research in the field of aging and age-associated diseases, promoting the exchange of knowledge and expertise for the advancement of scientific understanding. The NIA anticipates that the CERC will engage with NIA-supported exposome programs, as appropriate, in their proposed activities.

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

The NIAMS is interested in resource development activities as described for the future CERC, to advance exposomics research in rheumatic, skin and musculoskeletal diseases. The NIAMS anticipates that the CERC will engage with NIAMS-supported exposome programs, as appropriate, in their proposed activities.

National Institute of Neurological Disorders and Stroke (NINDS) Interests:

The NINDS is interested in resource development and dissemination activities as described for the future CERC to advance exposomics research that seeks fundamental knowledge about the brain and nervous system, and to use that knowledge to reduce the burden of neurological disease for all people. The NINDS anticipates that the CERC will engage with NINDS-supported exposome programs, as appropriate, in their proposed activities.

Office of Research on Women’s Health (ORWH) Interests:

The ORWH is part of the Office of the Director of NIH and works in partnership with the 27 NIH Institutes and Centers to ensure that women's health research is part of the scientific framework at the NIH and throughout the scientific community. Specific to this NOFO, promoting research that advances our understanding of the role and influence of sex traits and gender domains in health is of particular interest. The Office of Autoimmune Disease Research (OADR), housed within ORWH, is interested in supporting research which investigates the role of the exposome in the development, progression, responses to therapy and outcomes of autoimmune diseases.

Additional information

Applicant institutions should have the infrastructure, teams with diverse perspectives and partnerships, and commitment to support proposed activities. The Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)), are expected to be experienced in leading multi/transdisciplinary teams in the U.S. and globally. To meet the needs of a national and global program, the proposed CERC should consist of broad and diverse domain-specific expertise (chemical, biological, social, and data science) required for exposome research coordination and a strong central leadership.

Due to the unique requirements of this NOFO, applicants are strongly encouraged to consult with the Scientific Program Contacts listed here early in the application planning process. 

Plan for Enhancing Diverse Perspectives

The 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, the 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 exposure science, toxicology, epidemiology, social science, 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 FOA 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 material.

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 that fail to include a PEDP will be considered incomplete and will be withdrawn.

See Section VIII. Other Information for award authorities and regulations.

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

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are not 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 Grants Policy Statement Section 2.3.9.2 Electronically Submitted 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 registrations; 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 their 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 NIH Grants Policy Statement Section 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 NIH Grants Policy Statement 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, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this NOFO. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide except where instructed in this notice of funding opportunity to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

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:

Leroy Worth Jr, PhD
Telephone: 984-287-3340
Email: [email protected]

Page Limitations

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

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this NOFO.

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424(R&R) Other Project Information

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

SF424(R&R) Senior/Key Person Profile

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

Describe the knowledge and prior experiences of the PD(s)/PI(s) in leading and managing large, complex programs involving multi-disciplinary teams of scientists. The contact PD/PI must commit and maintain through the life of the award a minimum of 3.0 person-months (25% of full-time professional effort) to this program. For applications with multiple PDs/PIs, a minimum of 2 person-months (17%) effort is required for the Contact PD/PI and 1.2 person-months (10%) for each additional PD/PI.

R&R Budget

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

PEDP implementation costs:

• 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).

R&R Subaward Budget

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

PHS 398 Cover Page Supplement

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

PHS 398 Research Plan

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

Specific Aims: Outline the general objectives of the proposed CERC and the overall approach to achieving these goals. Proposed specific aims must support the objectives of this research program as described in Section I. Funding Opportunity Description.   

Research Strategy: The Research Strategy section must document the applicant’s independent research expertise, experience in national and global exposome research collaboration and communication, and ability for leading multidisciplinary teams. Research Strategy should also clearly outline the organization and leadership structure to best support the various functions and activities of the CERC (provide relevant organizational diagrams). Describe the lines of responsibilities, including, as applicable, the effort distribution across areas of CERC activities.

For developing a commonly agreed upon framework for exposomics, at a minimum, describe:

• Relevant stakeholders in the U.S. and around the globe
• Strategies for outreaching, engagement, and consensus building
• Coordination with the European “Global Coordination of Exposome Research”
• Plans for dissemination in the broad biomedical research community

For promoting methods standardization, harmonization and best practices, at a minimum, describe:

• A plan for developing a community resource for methods and tool sharing and how to sustain the resource after the funding ends
• Commonly used methods and tools for exposomics that the CERC will work on initially (for standardization, harmonization or developing best practices)
• Plans for community engagement, standards and best practice development, and implementation of standards and best practices developed; How to coordinate with partners around the globe   
• A proposed timeline of planned activities

For building a global exposome community, at a minimum, describe:

• A plan for developing a Global Human Exposome Network, working with the European effort, and how it will serve and interact with the broad biomedical research community  
• Plans for promoting exposome education and research capacity building
• Strategies for fostering national and international collaborations
• How to identify research priorities and address challenges as a community  

Additionally, the application must explain how the proposed activities will lead to better coordination and cooperation across various exposome efforts as well as innovation and advancement in exposomics.

Plan for Enhancing Diverse Perspectives (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, including those from underrepresented groups in research.

For further information on the Plan for Enhancing Diverse Perspectives (PEDP), please see https://braininitiative.nih.gov/about/plan-enhancing-diverse-perspectives-pedp.

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.

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.

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 Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

• No publications or other material, with the exception of blank questionnaires or blank surveys, may be included in the Appendix.

PHS Human Subjects and Clinical Trials Information

When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or 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.

PHS Assignment Request Form

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

3. Unique Entity Identifier and System for Award Management (SAM)

See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

4. Submission Dates and Times

Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). 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 Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

7. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply – Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile 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. See Section III of this NOFO for information on registration requirements.

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.

See more tips for avoiding common errors.

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

Prior Consultation with Scientific/Research Staff

Consultation with relevant NIH Scientific/Research staff is strongly encouraged. Staff can advise whether the proposed project meets the goals of this NOFO and discuss responsiveness questions. Staff will not evaluate the technical and scientific merit of the proposed project; technical and scientific merit will be determined during peer review using the review criteria indicated in this NOFO.

To expedite review, applicants are requested to notify NIEHS Referral Office by email at [email protected] 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.

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.

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.

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.

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 National Advisory Environmental Health Sciences Council. 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 2.4.4 Disposition of Applications.

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.

Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that 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.

2. Administrative and National Policy Requirements

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 Standard Terms and Conditions for Research Grants
• 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 term and condition of receiving the grant, to administer their 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. Please 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.html and https://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.”

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (HHS) grant administration regulations at 2 CFR Part 200, and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the recipients is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the recipients for the project as a whole, although specific tasks and activities may be shared among the recipients and NIH as defined below.

The PD(s)/PI(s) will have the primary responsibility for:

• Setting project timelines and operations of the CERC.
• Coordinating CERC activities technically, scientifically, and administratively.
• Organizing face-to-face or virtual meetings, conferences, and workshops.
• Adhering to policies regarding data access and intellectual property established by the NIH and CERC.
• Collaborating with CERC investigators and other stakeholders to make the CERC resource available to the broad community.
• Recipients will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies.

NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

NIH Program staff member acting as a Project Scientist will have substantial involvement that is above and beyond the normal stewardship role in awards. The Project Scientist will serve as the contact point for all facets of the scientific interaction with the recipient. As required for the coordinating activities and to expedite progress, NIEHS may designate additional NIH staff to provide advice to the recipient on specific scientific and/or analytic issues. The Project Scientist will:

• Review and comment on critical stages of program implementation.
• Assist in identifying and facilitating interactions with relevant ongoing exposome efforts and relevant NIH programs or recipients to share project information as appropriate.
• Work closely with the CERC recipient to ensure guiding principles and best practices developed will align with relevant NIH efforts and comply with NIH policies.
• Interact with the PD(s)/PI(s) on a regular basis, which may include regular communications with the Program Director/Principal Investigator and staff, periodic site visits, fiscal review, and other relevant matters.
• Serve on the Steering Committee of the program to address issues that arise with planning, operation, assessment, coordination, and dissemination.
• Formally assess CERC progress on an annual basis to advise the Program Official. Additionally, an agency program official or IC program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

  Areas of Joint Responsibility include:

  • None; all responsibilities are divided between recipients and NIH staff as described above.

  Dispute Resolution:

  Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between recipients and NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual recipient. This special dispute resolution procedure does not alter the recipient's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and HHS regulation 45 CFR Part 16.

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.

4. Reporting

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.

Awardees will provide updates at least annually on implementation of the PEDP.

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: [email protected] (preferred method of contact)
Telephone: 301-480-7075

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]

Yuxia Cui, PhD
Program/Scientific Officer
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 984-287-3251
Email: [email protected]

Ricardo Cibotti, Ph.D.                                          
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Telephone: (301) 451-5888
Email:  [email protected]

Richard Kwok, Ph.D.
National Institute on Aging (NIA)
Division of Neuroscience (DN)
Email: [email protected]

Emerald Nguyen, Ph.D.
National Institute on Aging (NIA)
Division of Behavioral and Social Research (DBSR)
Phone: 301-402-7571
Email: [email protected]

Jennifer Fox, Ph.D.
National Institute on Aging (NIA)
Division of Aging Biology (DAB)
Phone: 301-402-4816
Email: [email protected]

David A. Jett, Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)
Phone: (301) 496-6035
Email: [email protected]

Curt DellaValle, Ph.D., MPH
National Cancer Institute (NCI)
Telephone: 240-276-7225
Email: [email protected]

Susan A. Laessig, Ph.D
Environmental influences on Child Health Outcomes (ECHO)
Telephone: 301-435-1045
Email: [email protected]

Sarah M. Temkin, M.D.
Office of Research on Women’s Health (ORWH)
Telephone: 301-402-7630
Email: [email protected]

Karen Wylie, Ph.D.
Office of Research on Women’s Health (ORWH)
Telephone: 301-827-1808
Email: [email protected]
 

Leroy Worth Jr, PhD
Scientific Review Officer (NIEHS)
Telephone: 984-287-3340
Email: [email protected]

James Williams
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 984-287-3338
Email: [email protected]

Erik Edgerton
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Tel:  (301) 594-7760
Email:  [email protected] 

Jeni Smits
National Institute on Aging (NIA)
Email: [email protected]

Jessi Perez
National Institute on Aging (NIA)
Phone: 301-402-7739
Email: [email protected]

Ryan Blakeney
National Institute on Aging (NIA)
Phone: 301-451-9802
Email: [email protected]
 

Chief Grants Management Officer
National Institute of Neurological Disorders and Stroke (NINDS)
Email: [email protected]

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.