Department of Health
and Human Services (HHS)
and Human Services (HHS)
EXPIRED
National Institutes of Health (NIH)
National Institute of Environmental Health Sciences (NIEHS)
R24 Resource-Related Research Projects
NOT-OD-22-195 - New NIH "FORMS-H" Grant Application Forms and Instructions Coming for Due Dates on or after January 25, 2023
NOT-OD-22-189 - Implementation Details for the NIH Data Management and Sharing Policy
NOT-OD-22-198 - Implementation Changes for Genomic Data Sharing Plans Included with Applications Due on or after January 25, 2023
NOT-OD-23-012 - Reminder: FORMS-H Grant Application Forms & Instructions Must be Used for Due Dates On or After January 25, 2023 - New Grant Application Instructions Now Available
The purpose of this Funding Opportunity Announcement (FOA) is to support resource projects to enable Environmental Health Sciences (EHS) communities to openly develop, extend, adapt, or refine data and metadata standards as well as associated tools to implement standards. The initiative is intended to catalyze community-driven standards development and related implementation in environmental health. Projects can support activities at any point in the data standards lifecycle and should build on existing resources, infrastructure, and partnerships whenever possible. The standards, software, best practices, or other tools developed should be broadly disseminated for adoption by the relevant biomedical communities.
April 10, 2023
| Application Due Dates | Review and Award Cycles | ||||
|---|---|---|---|---|---|
| New | Renewal / Resubmission / Revision (as allowed) | AIDS | Scientific Merit Review | Advisory Council Review | Earliest Start Date |
| May 10, 2023 | Not Applicable | Not Applicable | September 2023 | January 2024 | April 2024 |
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.
Not Applicable
It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from NIH Guide for Grants and Contracts).
Conformance to all requirements (both in the Application Guide and the FOA) 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.
Background
The use of standardized approaches to describe and share scientific data, methods, and knowledge is critical for a variety of needs, including helping researchers to find, procure, and integrate data and knowledge, conduct comparative analysis, and promote common understanding. This is especially important for Environmental Health Sciences (EHS) research due to the volume, diversity, and complexity of the data sources involved, as well as the diverse perspectives involved in the generation, interpretation, integration, and use of these data. Over the past decade, discussions at workshops addressing an array of environmental health-related topic areas, including the 2021 Workshop on Integrating Multiscale Geospatial Environmental Data into Large Population Health Studies (https://www.niehs.nih.gov/news/events/pastmtg/2021/dert_geospatial_2021/index.cfm) and the 2022 Virtual Workshop Series on Accelerating Precision Environmental Health: Demonstrating the Value of the Exposome (https://www.niehs.nih.gov/news/events/pastmtg/2022/exposomics2022/index.cfm), reflect a desire by the exposure science, environmental epidemiology, toxicology, and other EHS domain communities to foster the development of data and metadata standards to improve research workflows, facilitate data harmonization, and increase data reuse.
A sustained focus of NIEHS has been engagement of the community around the development and adoption of harmonized language for environmental health. These efforts include the 2013 EPA-NIEHS Workshop for Advancing Environmental Health Data Sharing and Analysis: Finding a Common Language (https://www.niehs.nih.gov/news/events/pastmtg/2013/epa-niehs-health-data/index.cfm) and the 2014 Workshop for the Development of a Framework for Environmental Health Science Language (https://www.niehs.nih.gov/news/events/pastmtg/2014/language/index.cfm). In 2021, NIEHS launched the Environmental Health Language Collaborative (EHLC) (https://www.niehs.nih.gov/research/programs/ehlc/index.cfm) to coordinate an ongoing community discussion around advancing integrative environmental health research by promoting access, use, and harmonization of data through interoperable terminologies and best practices. EHLC community events are open to anyone interested in advancing environmental health sciences research through the development and adoption of a harmonized language. These ongoing forums include a public webinar series, use case-based working groups, and a workshop series, which launched with the 2021 Virtual Workshop on Catalyzing Knowledge-driven Discovery in Environmental Health Sciences Through a Harmonized Language (https://www.niehs.nih.gov/news/events/pastmtg/2021/ehslanguage/index.cfm). Through these efforts, the EHLC initiative aims to build a community of practice to exchange information, ideas, and expertise around language approaches to enable data querying, sharing, and interoperability.
However, several key limitations remain, and there is a critical need for development of community-driven data and metadata standards across many EHS subdomain areas as well as tools, software, and workflows to implement standards. Gaps in standard terminologies, vocabularies, ontologies, and related tools hamper the capabilities to address large-scale, complex EHS research questions that require the integration of disparate data and knowledge sources. The data and metadata standardization needs within EHS are diverse, and standards gaps persist in EHS focus areas including multi-omics, chemistry, toxicology, epidemiology, exposure science, exposomics, phenotypes, geospatial data, and clinical health records among others. To this end, the focus of this funding opportunity is to advance community-driven data and metadata standards development and implementation efforts in key EHS domains.
Resource Objectives
The purpose of the FOA is to support resource projects to enable EHS domain and/or subdomain communities to openly develop, extend, adapt, or refine data and metadata standards as well as associated tools to implement standards. This program is intended to provide catalytic support for a diverse array of EHS-focused standards development activities that address unmet needs within the NIEHS strategic mission. This initiative is intended to address gap areas related to environmental health-related data sources and is not intended to address gap areas for broader areas of biomedical research.
'Data and metadata standards are broadly defined to be documented agreements on representation, format, definition, structuring, tagging, transmission, manipulation, use, and management of data. A primary focus of this initiative is on EHS language standards and tools to implement those standards. In addition, gaps in data standards related to collection, transmission, and formatting of environmental exposure data are of interest. For instance, standards of interest may specify what types of metadata should be collected for any given dataset or data type, what format the metadata should be in, what units and terminologies should be used, and the file format to be used for the metadata.
Applications may be scoped around one or more science or topic areas relevant to the NIEHS mission. Applications must address standardization challenges at the level of the broad domain or subdomain community rather than at the level of an individual project, program, or institution. Projects must demonstrate a compelling science community interest and need for standards efforts in the specific domain(s) of interest, as well as a plan for meaningful engagement of the relevant contributors and end-user communities in the process.
This FOA is intended to support activities at any point in the data standards lifecycle. The 'data standards lifecycle' includes the (a) development (including initiation, establishment of key collaborators/contributors/user-communities and working groups, establishment of requirements/use cases, design, test, and approval), (b) dissemination and distribution, (c) adoption and use, (d) evaluation, and (e) maintenance (including review, revision, and retirement) of a standard.
Activities in the following three areas can be supported under this FOA: (1) collaborator, contributor, and user-community engagement, (2) open standards for data and metadata, and (3) tools for standards implementation. Responsive applications will include:
It is critical that standards development, tool development, and community engagement be synchronized (rather than sequential) to support timely adoption in the relevant scientific communities. Regardless of the specific activities proposed, all applications should clearly describe the relationships, interactions, and synchronization across the standards, tools, and communities relevant to the proposed resource.
Specific Areas of Interest
Examples of activities within the three categories that can be supported under this FOA include, but are not limited to the following:
1. Collaborator, contributor, and user-community engagement
Activities of interest involve engaging relevant persons, groups, and organizations throughout the data standards lifecycle. Within this context, the community for a given standard encompasses a broad and diverse range of individuals or groups involved at various points throughout the lifecycle including, but not limited to science domain experts, researchers, ontologists, librarians, data scientists, data stewards, data engineers, software developers, vendors, repositories, societies, publishers, advocacy groups, and other end-users. Data scientists, engineers, or related experts in domains outside of environmental health are also important community members to consider.
Examples of activities that may be appropriate for this FOA include, but are not limited to, the following:
2. Open standards for data and metadata
Activities of interest include developing, extending, adapting, or refining data and metadata standards in key gap areas of the environmental health language. The intended scope is to support curation and harmonization for one or more science areas relevant to the NIEHS mission. These standards should promote consistent information sharing, interoperability, and common understanding.
Examples of standards that may be appropriate for this FOA include, but are not limited to, the following:
3. Tools for standards implementation
Activities of interest include developing, extending, adapting, or refining software tools to implement data and metadata standards for the EHS community. The intended scope is to make it easier for people to curate and share high quality data and to facilitate broad adoption of consensus standards.
Examples of tools that may be appropriate for this FOA include, but are not limited to, the following:
Program Expectations
This program intends to support projects that provide open resources to enhance EHS research and data infrastructure. All standards, software tools, and best practices developed, extended, or otherwise enhanced through this program should be openly disseminated for broad adoption by the relevant biomedical communities, following best practices for sharing research software (https://datascience.nih.gov/tools-and-analytics/best-practices-for-sharing-research-software-faq) as well as FAIR (Findable, Accessible, Interoperable, Reusable; https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4792175/) principles for associated data and documentation.
Projects funded through this FOA should leverage and build on existing resources. It is expected that the need to develop a standard de novo will be rare and that most projects will adapt, refine, or extend one or more existing standards and/or tools. Furthermore, projects should address long-term maintenance and sustainability of the data standard after the period of the NIH award, including approaches for dissemination, evaluation, and updating/refinement. Applicants should identify organizational partners and support mechanisms that may be available to enable continued development and maintenance of the standard.
Applicants that are funded are expected to participate in a yearly program meeting to report on project goals and milestones, share lessons learned, and make recommendations that will be shared with the NIEHS research community. Awardees will also be expected to participate in program-related teleconferences and/or working groups that align with their projects.
Non-responsive applications
Awards supporting resources differ from typical research (e.g., R01) grants. The following types of applications will be considered non-responsive to this FOA and returned without review:
Applicants are strongly encouraged to contact the NIEHS Scientific/Research staff listed in Section VII prior to submission to ensure their project is responsive to this FOA.
See Section VIII. Other Information for award authorities and regulations.
Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.
The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA.
Not Allowed: Only accepting applications that do not propose clinical trials.
NIEHS intends to commit $4 million in FY 2024 to fund 5-7 awards.
Application budgets are limited to $400,000 direct cost per year and should reflect the actual needs of the proposed project.
The scope of the proposed project should determine the project period. The maximum project period is 5 years.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.
1. Eligible Applicants
Higher Education Institutions
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
Nonprofits Other Than Institutions of Higher Education
For-Profit Organizations
Local Governments
Federal Government
Other
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 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.
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 FOA 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:
1. Requesting an Application Package
The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.
2. Content and Form of Application Submission
It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.
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:
The letter of intent should be sent to:
Alfonso R. Latoni, PhD
Telephone: 984-287-3279
Fax: 301-480-3704
Email: [email protected]
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 FOA.
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.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
R&R Budget
All instructions in the SF424 (R&R) Application Guide must be followed.
The PD/PI and a limited number of key collaborators should allocate travel funds in the budget for participation in a yearly in-person program meeting. Awardees will also be expected to participate in program-related teleconferences and/or working groups that align with their projects.
R&R Subaward Budget
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
Research Strategy:
The goal of this FOA is to support data and metadata standards development and implementation activities to serve the mission of the NIEHS. In support of this goal, investigators should present a compelling justification and action plan for the proposed standards resource(s), tool(s), and implementation activities.
Applicants must address each of the following elements:
Letters of Support:
Applicants are encouraged to provide letters of support from collaborators, contributors, and/or potential users of the proposed resource(s). These letters should provide details on the nature of the proposed interaction/collaboration, and as appropriate, document community interest in participating in development, evaluation, and/or other project activities, document interest in the adoption and use of the proposed standard(s) and/or tool(s), and describe how the proposed resource(s) will benefit their research or related work.
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:
Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
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.
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
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 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.
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.
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 fieldof 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 FOA 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 NIEHS. Applications that are incomplete or non-compliant will not be reviewed.
Applicants are required to follow the instructions for post-submission materials, as described in the policy
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.
Note: Effective for due dates on or after January 25, 2023, the Data Sharing Plan and Genomic Data Sharing Plan (GDS) will not be evaluated at time of review.
For this particular announcement, note the following:
The focus of this R24 funding opportunity is to support projects that will enhance research data infrastructure by providing high-value open data and metadata standards resources to serve Environmental Health Sciences (EHS) domain communities. Emphasis is on supporting activities across the data standards lifecycle that:
Overall Impact
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).
Scored Review Criteria
Reviewers will consider each of the review criteria below in the determination of scientific merit and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.
Significance
Does the proposed resource address the needs of the research community that it will serve?
Is the scope of activities proposed for the resource appropriate to meet those needs?
Will successful completion of the aims bring unique advantages or capabilities to the research community?
Specific to this FOA:
Does the mission statement clearly articulate the scientific areas covered?
Does the proposed resource address a key gap in the Environmental Health Sciences, building on existing resources as appropriate?
Will the resource have a national and international footprint in the appropriate scientific communities?
Is the potential user community sufficiently broad and does the resource’s userbase represent a significant coverage of potential users and appropriate scientific domains to warrant support?
Will this work promote FAIR principles, i.e., to make research data Findable, Accessible, Interoperable, and Reusable?
Investigator(s)
Are the PD(s)/PI(s) and other personnel well suited to their roles in the resource project?
Do they have appropriate experience and training, and have they demonstrated experience and an ongoing record of accomplishments in managing community-driven standards development and/or data standards implementation in environmental health, biomedical, or related research?
Do the investigators demonstrate significant experience with coordinating collaborative multidisciplinary research?
If the project is multi-PD/PI, do the investigators have complementary and integrated expertise and skills; are their leadership approach, governance, plans for conflict resolution, and organizational structure appropriate for the resource?
Does the applicant have experience overseeing selection and management of subawards, if needed?
Specific to this FOA:
Are appropriate relationships/interactions with existing standards organizations, infrastructure, and/or other resources defined?
Are appropriate relationships/interactions with relevant contributors and end-user communities defined?
Innovation
Does the application propose a resource not otherwise available to the broader research community?
Are the concepts, strategies, or instrumentation novel to one type of research program or applicable in a broad sense?
Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?
Specific to this FOA:
Note that for the purposes of this initiative, innovation is defined as applying to the goals, usage, utility, interoperability, and impact of the proposed resource(s) for one or more relevant end-user communities, and not necessarily the development of novel theoretical concepts, approaches, or methodologies. The approaches employed may be based on existing methods, and applicants are encouraged to leverage and build on existing resources (e.g., standards, tools, and other infrastructure) where appropriate.
Approach
Are the overall strategy, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of the resource?
Will the investigators promote strategies to ensure a robust and unbiased scientific approach across the resource, as appropriate for the work proposed?
Are potential problems, alternative strategies, and benchmarks for success presented?
If the resource is in the early stages of operation, does the proposed strategy adequately establish feasibility and manage the risks associated with the activities of the resource?
Is an appropriate plan for work-flow and a well-established timeline proposed?
Have the investigators presented adequate plans to ensure consideration of relevant biological variables, such as sex, for studies of 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 to this FOA:
Does the application clearly justify the science community need and intended userbase for the resource?
Does the application adequately leverage, harmonize, and/or interoperate with existing standards, infrastructure, tools, partnerships, and/or other resources relevant to the proposed work?
Does the approach outline an appropriate plan for distribution and implementation of the resource to the broader community?
Does the approach outline a plan for meaningful engagement of the relevant contributors and end-user communities in the data standards lifecycle?
Is the proposed governance model appropriate, and are the processes that will be used for decision making adequately described?
Are there adequate plans for sustainability of the resource beyond the proposed period of support?
Are appropriate approaches described to evaluate the usage, utility, and impact of the proposed resource?
Environment
Will the institutional environment in which the resource project will operate contribute to the probability of success in facilitating the research community it serves?
Are the institutional support, equipment and other physical resources available to the investigators adequate for the resource proposed?
Will the resource project benefit from unique features of the institutional environment, infrastructure, or personnel? Are resources available within the scientific environment to support electronic information handling?
Specific to this FOA:
Does the application make use of state-of-the-art infrastructure and technologies needed to achieve the goals of the resource?
Additional Review Criteria
As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.
Protections for Human Subjects
For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.
Inclusion of Women, Minorities, and Individuals Across the Lifespan
When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals 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
Not Applicable.
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
Note: Effective for due dates on or after January 25, 2023, the Data Sharing Plan and Genomic Data Sharing Plan (GDS) will not be evaluated at time of review.
Reviewers will comment on whether the Resource Sharing Plan(s) (i.e., Sharing Model Organisms) or the rationale for not sharing the resources, is reasonable.
Authentication of Key Biological and/or Chemical Resources:
For resources 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.
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 FOA.
Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. 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:
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.
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.5. 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 FOA 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:
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 FOA.
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.
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.
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 FOAs 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 $25,000. 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 Appendix XII to 45 CFR Part 75, 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 Award Term and Conditions for Recipient Integrity and Performance Matters.
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]
Christopher G. Duncan, PhD
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 984-287-3256
Email: [email protected]
Alfonso R. Latoni, PhD
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 984-287-3279
Email: [email protected]
Jenny Greer
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 984-287-3332
Email: [email protected]
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.