Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute of Environmental Health Sciences (NIEHS)

Funding Opportunity Title
Maintaining and Enriching Environmental Epidemiology Cohorts to Support Scientific and Workforce Diversity (U24 Clinical Trial Not Allowed)
Activity Code

U24 Resource-Related Research Projects – Cooperative Agreements

Announcement Type
Reissue of RFA-ES-18-009
Related Notices

NOT-OD-22-018 - Reminder: FORMS-G Grant Application Forms & Instructions Must be Used for Due Dates On or After January 25, 2022 - New Grant Application Instructions Now Available

NOT-OD-21-181 - Updates to the Non-Discrimination Legal Requirements for NIH Recipients

NOT-OD-21-169 - New NIH "FORMS-G" Grant Application Forms and Instructions Coming for Due Dates on or after January 25, 2022

NOT-OD-21-170 - Update: Notification of Upcoming Change in Federal-wide Unique Entity Identifier Requirements

NOT-OD-21-109 - Expanding Requirement for eRA Commons IDs to All Senior/Key Personnel

Funding Opportunity Announcement (FOA) Number
RFA-ES-22-001
Companion Funding Opportunity
None
Assistance Listing Number(s)
93.113
Funding Opportunity Purpose

The purpose of this Funding Opportunity Announcement (FOA) is to solicit applications that propose to: (1) support the maintenance and resource infrastructure enrichment of existing Environmental Epidemiology Cohorts (EECs) and to (2) enrich data management and data sharing activities to promote widespread data sharing and scientific collaborations, while strengthening scientific and workforce diversity in environmental health.

Key Dates

Posted Date
January 04, 2022
Open Date (Earliest Submission Date)
February 08, 2022
Letter of Intent Due Date(s)

30 days prior to the application due date

Application Due Dates Review and Award Cycles
New Renewal / Resubmission / Revision (as allowed) AIDS Scientific Merit Review Advisory Council Review Earliest Start Date
March 08, 2022 March 08, 2022 Not Applicable June 2022 October 2022 December 2022
February 10, 2023 February 10, 2023 Not Applicable June 2023 October 2023 December 2023
February 13, 2024 February 13, 2024 Not Applicable June 2024 October 2024 December 2024

All applications are due by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on the listed date(s).

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.

Expiration Date
February 14, 2024
Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

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.

There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

  1. Use the NIH ASSIST system to prepare, submit and track your application online.
  2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.

  3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.


  4. Table of Contents

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Purpose

This Funding Opportunity Announcement solicits applications to provide support for the maintenance of existing environmental epidemiology cohorts (EECs) and their associated biorepositories; for the collection or development of additional measures including social determinants of health and structural racism; to facilitate enrollment of understudied populations in biomedical research and follow-up of study participants especially during key windows of susceptibility; enrichment of community engagement and outreach and to provide a structure to facilitate broader sharing of data and resources with the scientific community to strengthen workforce diversity in environmental health science and epidemiology and promote greater scientific collaboration. The scope of the application must address a critical research need and strategic interest that aligns with the mission of the National Institutes of Environmental Health Sciences (NIEHS). Investigators are encouraged to visit the NIEHS website for additional information about the mission and research priorities of the NIEHS https://www.niehs.nih.gov/about/strategicplan/.

Background

The mission of the NIEHS is to discover how the environment affects people, in order to promote healthier lives. As such, NIEHS makes significant investments in EECs that help scientists better understand how environmental exposures affect human health during different stages of life in various populations. These studies advance our understanding of how exposure to harmful chemicals, modifiable lifestyle factors, and genetics contribute to health and disease. Data from these EECs are a valuable resource to the entire environmental health community.

Still, for biomedical research to achieve scientific advances to improve human health in a diverse U.S. population, increased inclusion is necessary in environmental epidemiology cohorts and the biomedical workforce. Data from the National Science Foundation have shown that African Americans (or Blacks), American Indians and Alaska Natives, Hispanics (or Latinos), Native Hawaiians and other Pacific Islanders are underrepresented at many career stages in health-related sciences on a national basis (National Science Foundation, 2019 https://ncses.nsf.gov/pubs/nsf19304). Scientists from underrepresented populations are less likely to secure federal funding (https://diversity.nih.gov/building-evidence/racial-disparities-nih-funding), and face unique barriers pertaining to access to, and utilization of data sharing resources, especially at under-resourced institutions. Moreover, increased diversity in the environmental epidemiology community is a critical need that must be addressed. The American College of Epidemiology states that the profession needs to achieve racial, ethnic and cultural diversity, at all levels, in order to contribute fully to public health for all populations. See, Epidemiology and Minority Populations: Statement of Principles.

The ultimate goal of this Program is to maintain and maximize NIEHS cohort investments within the environmental epidemiology community by supporting the infrastructure needs to prepare for future research opportunities, improving data collection for understudied populations in environmental epidemiology studies, strengthening scientific, environmental epidemiology, and workforce diversity, and promoting greater scientific collaboration in environmental health science.

Scope of the FOA

This Program was initially established to create stable funding to retain trained field personnel who are essential to continued ongoing longitudinal data collection, to follow-up study participants, to continue community engagement activities, and to maintain and enhance sample collection and management of biorepositories. Additionally, a key component of this Program was the support for development of infrastructure within EECs to support data management and broad data sharing. While these components remain, the program has evolved and now requires cohort-relevant activities to support a diverse scientific workforce and enhance the breadth of populations represented in scientific inquiry. These activities may include expanding data collection for understudied populations to address topics related to environmental health equity, adopting data sharing practices that maximize appropriate data sharing with diverse communities, and/or fostering scientific collaborations to include minority-serving institutions and researchers from diverse backgrounds, including those from groups that have been underrepresented in the biomedical sciences.

Funded applicants will work together as a consortium to discuss, develop and/or incorporate common protocols for the integration of measures of upstream (structural racism) or midstream (social determinants of health) factors in existing environmental epidemiology studies, define common strategies for activities that build awareness of NIEHS-supported research data and support broad data sharing to promote greater scientific collaboration and strengthen workforce diversity. Additionally, this consortium is intended to serve as a resource for ancillary studies that will support career and professional development of researchers from diverse backgrounds, including those from populations underrepresented in environmental health science and epidemiology.

Activities to support the maintenance and enrichment of EECs are categorized as : (1) cohort maintenance and resource infrastructure enrichment for existing EECs and (2) enrichment of EEC data management and broad sharing of cohort resources. Each resource application must propose at least one of these two activity categories and additionally include elements that emphasize the inclusion of understudied populations in epidemiology cohorts, , researchers from diverse backgrounds, including those from groups underrepresented in the scientific workforce, and researchers at any career level from minority serving or under-resourced institutions in scientific collaborations. Examples of these elements could include, but are not limited to:

  • Infrastructure support to retain personnel, including community partnerships, essential to continue and expand cohort enrollment of understudied populations (where relevant).
  • Infrastructure support to add or retain personnel essential to the collection or development of additional measures necessary to advance environmental health equity and environmental justice .
  • Infrastructure support and personnel essential to data preparation to facilitate and ensure broader data sharing activities that include, but are not limited to, outreach to promote diversity in scientific collaborations.
  • Enhanced outreach activities to bring greater awareness to the research community of opportunities to pursue new and possibly unlikely collaborations and interdisciplinary partnerships.
  • Enhanced outreach activities to strengthen and sustain community engagement and partnerships.

Applications will be considered non-responsive if they do not include activities to enhance diversity in research study populations or the research workforce.

Examples of activities within these two categories that can be supported under this FOA include, but are not limited to the following:

(1) Cohort maintenance and resource infrastructure enrichment for existing EECs:

For new applications -

  • Ongoing recruitment and retention of the target study population.
  • Expansion of recruitment to enroll understudied populations to enhance the breadth of the science or power of the cohort.
  • Re-consenting of participants for broad data sharing as appropriate and consistent with achieving the goals of the program.
  • Continuation and enhancement of sample collection and management of existing biorepositories and environmental sample repositories to include data for communities disproportionately impacted by environmental exposures, racial and ethnic minorities, individuals from low income communities or other populations for which the data are scarce.
  • Continuation and enhancement of community engagement and outreach activities.
  • Additional data collection to add existing or develop novel measures or indicators of structural or individual racism as factors of exposure-outcome associations.

For renewals -

  • Expansion of data collection on existing participants to add measures of upstream socioeconomic factors to facilitate environmental health research.
  • Continuation and enhancement of community engagement and outreach activities to facilitate the direction of the science.
  • Development or validation of methodology to integrate measures of structural or individual racism data into existing research efforts.

(2) Enrichment of EEC data management and sharing:

Development of infrastructure including the retention or hiring of personnel to support broad sharing of data, including:

For new applications -

  • Implementation of an improved quality assurance and quality control plan across the full data life cycle, including the identification and handling of potentially erroneous or missing values.
  • Formatting and depositing individual-level de-identified data in an existing repository.
  • Development and implementation of a searchable web-based platform for broader data sharing and integration.
  • Linkage and integration of multiple data sets from different sources such as health records and environmental data sources to facilitate research to address social determinants of environmental health.

For renewals –

  • Building awareness of available NIEHS-supported epidemiological cohort data at minority serving institutions, and scientific conferences supporting communities disproportionately impacted by environmental exposures, career development of individuals from diverse backgrounds, including those from racial and ethnic minority populations, and individuals from low income communities.
  • Development and implementation of a searchable web-based platform for broader data sharing and integration.
  • Linkage and integration of multiple data sets from different sources such as health records and environmental data sources to address social determinants of environmental health.
  • The career and professional development of investigators from diverse backgrounds, including those from groups underrepresented in areas of environmental epidemiological assessment, including enhancing biospecimen collection and processing, and data management.
  • The development of relevant scientific collaborations with investigators from minority serving and under-resourced institutions.
  • Enabling data discovery and integration through development and utilization of standard, unambiguous terminology. This includes creation or enhancement of data dictionaries and ontologies. The use of descriptive terms from existing biomedical ontologies (e.g. NCBO BioPortal, https://bioportal.bioontology.org) is highly encouraged.
  • Development and application of methodologies to support interoperability of EEC data with other relevant data sets, including implementation of common data and metadata standards and evaluation of their utility to support data integration.
  • Formatting and depositing individual-level de-identified data in an established data repository.

Scientific Workforce Diversity: The NIH encourages institutions to increase the participation of individuals currently underrepresented in the biomedical, behavioral, clinical and social sciences such as: individuals from racial and ethnic groups that have been shown by the National Science Foundation to be underrepresented in health-related sciences on a national basis, individuals with disabilities, individuals from disadvantaged backgrounds, and women at the faculty level. For more information on NIH's interest in diversity, see NOT-OD-20-031, see also NOT-OD-22-019. To be responsive to this FOA, applicants must include a diversity plan. The plan should describe in sufficient detail how planned cohort enrichment and data sharing activities will strengthen the environmental health science and epidemiology workforce diversity and enhance the diversity of epidemiology cohorts (where relevant).

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

Section II. Award Information

Funding Instrument

Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this FOA.

Application Types Allowed
New
Renewal

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA.

Clinical Trial?

Not Allowed: Only accepting applications that do not propose clinical trials.

Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards

NIEHS intends to commit $2.5 million in FY2023 to fund 5-6 awards.  Future year amounts will depend on annual appropriations.

Award Budget
Application budgets are limited to $250,000 direct costs and need must reflect the actual costs of the proposed project.
Award 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.

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

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)
  • Eligible Agencies of the Federal Government

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
Foreign Institutions

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. 

Required Registrations

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.

  • Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
  • 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.
  • eRA Commons - Applicants must have an active DUNS number to register in eRA Commons. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration, but 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 DUNS number and SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account.  PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support. See, 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:

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

Section IV. Application and Submission Information

1. Requesting an Application Package

The application forms package specific to this opportunity must be accessed through ASSIST, 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.

 

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:

Dr. Linda K. Bass
Telephone: 984-287-3236
Fax: 919-541-2503
Email: bass@niehs.nih.gov

Page Limitations

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

Instructions for Application Submission

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.

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.

R&R Budget

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

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: Provide specific aims for the maintenance and enhancement of the cohort, as well as methods to facilitate broader use of data and sample resources.

Research Strategy: The Research Strategy must consist of the following sections:

Cohort Overview

  • Overall description and summary of the existingEEC.
  • Summary describing the EEC accomplishments related to both the infrastructure and the supported research including clinical and public health significance of the research using this cohort. Include a summary of the population, enrollment over time, data and biological specimen collection, and follow-up of cohort since the past project period. If a data sharing plan was implemented, include a report describing any or all data sharing activities.
  • The application should describe in detail the scientific rationale for the need to continue this cohort and the value and opportunities to the broader research agenda that this cohort will be designed to support in the immediate, intermediate, and long-term time frame.

Action Plan for Cohort Maintenance and Resource Infrastructure Enrichment

  • Cohort Maintenance: The application must clearly define catchment area or sampling frame and what activities are necessary to achieve the goals of the resource. The application should include justification for any new study questions, additional recruitment, sample/data enhancement and or enriched community engagement.
  • Resource Infrastructure:The application must describe the research team's plan for resource infrastructure enhancements aimed to support data preparation within cohort and/or data preparation for data linkage with extant data resources or for collaborations with any existing cohorts .

Action Plan for Enrichment of EEC Data Management and Sharing

  • The application should describe how the proposed enhancements will facilitate broader sharing of data with the scientific community.
  • The application must clearly describe the methods used to make data findable, accessible, and reusable. As appropriate, describe efforts for harmonization and alignment with existing (meta) data standards.
  • Description of milestones and timelines for making data publicly available.

Leadership and the Administrative Plan

  • Leadership: The use of the multiple PD/PIs is strongly encouraged. Applicants are encouraged to bring in new expertise in areas including health equity, environmental justice, social epidemiology, social determinants of health, environmental racism.
  • Administrative Plan: Describe the administrative model for the proposed activities, including responsibilities for communication, decision making, and oversight. Please provide a summary of the types and funding sources that were used to establish and maintain EEC to date.

Scientific and Workforce Diversity Plan

  • All applications must include a Scientific and Workforce Diversity Plan. The plan should describe in detail how planned cohort enrichment and data sharing activities will strengthen the environmental health science and epidemiology workforce diversity and enhance the diversity of epidemiology cohorts (where relevant)..

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.

The following modifications also apply.

All applications, regardless of the amount of direct costs requested for any one year, must address a Data Sharing Plan. The Data Sharing Plan should describe the approach for how the scientific data generated from the proposed project and any accompanying metadata will be managed, preserved, and shared, taking into account any potential restrictions or limitations. The plan should not exceed two pages in length. The plan should address each of the following elements:

  • Description of the scientific data to be managed, preserved and shared over the life of the proposed project;
  • Description of the tools, software, and/or code needed to access and/or interpret the data;
  • Description of standards to be applied to the scientific data and associated metadata;
  • Plans and timelines for data preservation and access;
  • Description of factors affecting access, distribution, or reuse of scientific data; and
  • Plans for oversight of data management and sharing.

Additional information on each of the elements to be addressed in the Data Sharing Plan can be found in NOT-OD-21-014. NIH strongly encourages the use of established repositories to the extent possible for preserving and sharing scientific data.

Appendix:
Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
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 Policy on Late Application Submission.

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

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

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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

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

7. Other Submission Requirements and Information

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

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

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

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. 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, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

In order to expedite review, applicants are requested to notify the NIEHS Referral Office by email at bass@niehs.nih.gov when the application has been submitted. Please include the FOA 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. Any instructions provided here are in addition to the instructions 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.

For this particular announcement, note the following:

The U24 mechanism seeks to support research projects contributing to the improvement of the capability of resources to serve biomedical research, allowing for extensive programmatic involvement. Since applications are to focus on resources to support research, the application will contain details about the value of the cohort as it relates to the success of the research conducted using the cohort, the level of innovation, the potential to significantly advance biomedical research, the opportunities to enhance the breadth of populations represented in scientific inquiry, the opportunities to support diversity in the environmental health science and epidemiology workforce that may arise by supporting the continuation of the cohort, and unique contribution to the field.

Reviewers will emphasize the base of science and knowledge created using the extant Environmental Epidemiology Cohort, the opportunity for future collaboration outside the applicant's scientific or local network of collaborators, the quality of the existing data collected and the added value to continue support. Reviewers will look at past progress of grants using cohort, publications, and science translation.

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

 

Specific to this FOA: Will the maintenance of the cohort improve scientific knowledge and improve public health? If applicable, evaluate how the maintenance of the cohort will improve scientific knowledge on understudied populations in epidemiological research. Will the proposed project activities improve access to the cohort data and resources for the broader scientific community? Does the application make a compelling case that the maintenance of the EEC will support diversity in the environmental health science and epidemiology workforce? Does the project support collaborations inclusive of minority serving or under-resourced institutions? Evaluate how the successful completion of the proposed aims will provide knowledge to advance current research concepts, methods, technologies, prevention strategies or diversity in the field of environmental health.

Investigator(s)

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

Specific to this FOA: Does the applicant have experience overseeing selection and management of subawards, if needed?   

Does the proposed leadership plan include a collaborative or multi-PD/PI with appropriate expertise to complement the scientific oversight and leadership to strengthen scientific or workforce diversity?

Innovation

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

Specific to this FOA: Does the proposed EEC infrastructure have the ability to support innovative and yet broad research agenda? Are the applicants proposing to use state-of-the-art tools and technologies to maintain and or enhance cohort recruitment/attainment, collect relevant environmental exposure data and biological samples, and manage cohort data? Have they developed a cogent and operable process, policy and infrastructure to support broad sharing of cohort data and biological specimens?

Approach

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

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

For the Data Sharing Plan, reviewers will evaluate each of the elements of the plan and whether the proposed plan will likely lead to broader sharing of the data.

Environment

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

Are resources available within the scientific environment to support electronic information handling?

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 Animal Section.

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

Not Applicable

Renewals

 For Renewal applications evaluate how the activities carried out during the previous funding period(s) supported broad sharing of cohort data, resources, and biological specimens to the broader scientific community, and assess the degree in which the sharing of data extended beyond the cohort investigators and research team. Evaluate the type of activities conducted, whether they reached their targeted goals of enrollment, and the contributions of these activities to the field.

Revisions

Not Applicable

Additional Review Considerations

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

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Sharing Model Organisms; and (2) Genomic Data Sharing Plan (GDS).

Authentication of Key Biological and/or Chemical Resources:

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

Budget and Period of Support

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

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by NIEHS Scientific Review Branch, 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 (NAEHSC). The following will be considered in making funding decisions:
  • Scientific and technical merit of the proposed project as determined by scientific peer review.
  • Availability of funds.
  • Relevance of the proposed project to program priorities.

3. Anticipated Announcement and Award Dates

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

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

Section VI. Award Administration Information

1. Award Notices

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

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

Recipients must comply with any funding restrictions described in Section IV.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.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex. This includes ensuring programs are accessible to persons with limited English proficiency. 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 http://www.hhs.gov/ocr/civilrights/understanding/section1557/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.

Cooperative Agreement Terms and Conditions of Award

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 (DHHS) grant administration regulations at 45 CFR Part 75, 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 award 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 the NIH as defined below.

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

  • PD(s)/PI(s) will agree to collaborate with NIH staff in regards to the scientific and technical management of the project as described under "NIH Program Staff Responsibilities".
  • 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 DHHS, PHS, and NIH policies.
  • Implementation of planned cohort maintenance and infrastructure enrichment activities.
  • Implementation of planned scientific and workforce diversity activities.
  • Implementation of planned strategies that facilitate broad data sharing.
  • Development, and/or use of common protocols for the integration of structural racism and social determinants of health measures in existing environmental epidemiology studies. Participation in Program meetings, webinars, and opportunities to engage with the scientific community in awareness-building activities.

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

  • 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.
  • Provide assistance to recipients in performing project activities, e.g., assistance with the selection of key project personnel other than principal investigators essential for data science, data sharing activities.
  • Provide ongoing oversight or monitoring of the data sharing activities for the project, including recommending changes or modifications in outreach approaches as appropriate.
  • Identify and coordinate opportunities for grantees to participate in awareness building activities that will support data sharing activities
  • Review pilot projects to ensure that aims are within the scope of the parent award and maximize NIEHS investment in existing environmental epidemiology cohort resources.

Areas of Joint Responsibility include:

  • Participation in the development of common protocols for the integration of structural racism and social determinants of health measures in existing environmental epidemiology studies.
  • Participation in the development of or defining common strategies for activities that build awareness of NIEHS-supported research data and support broad data sharing to promote greater scientific collaboration and strengthen workforce diversity.
  • Identification of expertise and resources to provide strategies/best practices for engaging MSIs, under-resourced institutions, culturally relevant mentorship of investigators, including those from underrepresented groups.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: 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 DHHS regulation 45 CFR Part 16

3. 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.

Section VII. Agency Contacts

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

Application Submission Contacts

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: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-945-7573

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

Scientific/Research Contact(s)

Melissa M. Smarr, PhD
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 984-287-4507
Email: melissa.smarr@nih.gov

Kimberly Ann Gray, PhD
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 984-287-3262
Email: kimberly.gray@nih.gov

Christopher G. Duncan, PhD
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 984-287-3256
Email: duncancg@niehs.nih.gov










Peer Review Contact(s)

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

Financial/Grants Management Contact(s)

Barbara J. Gittleman
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 984-287-3261
Email: barbara.gittleman@nih.gov

Section VIII. Other Information

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

Authority and Regulations

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, 2 CFR Part 200, and 45 CFR Part 75.

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