Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s)

National Institutes of Health (NIH)

National Science Foundation (NSF)

Components of Participating Organizations

National Institute of Environmental Health Sciences (NIEHS)

Geosciences Directorate, Division of Ocean Sciences (GEO/OCE)

Funding Opportunity Title
Centers for Oceans and Human Health 4: Impacts of Climate Change on Oceans and Great Lakes (COHH4) (P01 Clinal Trial Optional)
Activity Code

P01 Research Program Projects

Announcement Type
Reissue of RFA-ES-16-009
Related Notices

NOT-OD-22-190 - Adjustments to NIH and AHRQ Grant Application Due Dates Between September 22 and September 30, 2022

Funding Opportunity Announcement (FOA) Number
RFA-ES-22-005
Companion Funding Opportunity
None
Assistance Listing Number(s)
93.113; 47.050
Funding Opportunity Purpose

The purpose of this Funding Opportunity Announcement (FOA) is to invite new and renewal applications for Centers for Oceans and Human Health. These multi-component projects will characterize and evaluate the impact of climate change on emerging public health threats associated with marine and Great Lakes Basin environments. Each center will include distinct but integrated research projects on marine or Great Lakes exposures, mechanisms of toxicity or human exposure, and the influence of climate change, using multidisciplinary ocean science, analytical, toxicological and biomedical approaches. Centers will foster strong community partnerships through a Community Engagement Core for impactful communication and translation of research.

Key Dates

Posted Date
August 31, 2022
Open Date (Earliest Submission Date)
October 01, 2022
Letter of Intent Due Date(s)

October 01, 2022

Application Due Dates Review and Award Cycles
New Renewal / Resubmission / Revision (as allowed) AIDS Scientific Merit Review Advisory Council Review Earliest Start Date
November 01, 2022 November 01, 2022 Not Applicable July 2023 October 2023 December 2023

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.

Expiration Date
November 02, 2022
Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the Multi-Project (M) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the 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. Table of Contents

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Purpose

The oceans and Great Lakes continue to withstand the consequences of human activity and pollution, in addition to climate change-related events that further disrupt aquatic ecosystems and give rise to hazardous exposures. Specific impacts of climate change on marine and lacustrine environments, including higher water temperatures, rising sea levels, and increases in the frequency and duration of severe weather events, are already being observed, as are consequences on coastal populations and those surrounding the Great Lakes. Unprecedented and/or unanticipated health problems or health threats from climate change may also be seen in places where they have not previously occurred. The National Science Foundation (NSF) and the National Institute of Environmental Health Sciences (NIEHS) are jointly releasing the fourth Oceans and Human Health FOA (COHH4) to solicit applications for multi-component projects that will develop multidisciplinary research centers focused on human health effects related to events and exposures in marine or Great Lakes environments that are associated with climate change.

The scope of research solicited by this program spans studies involving human health in relation to marine and freshwater environments; for example, (1) understand human exposure to and mechanisms of toxicity underlying health impacts from marine and Great Lakes toxicants, (2) develop methods to detect, quantify and forecast ocean-related health threats, including improved surveillance and monitoring of disease-causing agents in coastal waters, marine organisms (esp. seafood), aerosols, sediments, and exposed human populations, and (3) identify relationships among parameters of climate change and increased human exposure to toxins and waterborne pathogens. Each Center will include a Community Engagement Core (CEC) (described in section B, below) through which they will engage communities in collaborative activities. Community engagement can also be an integral part of research projects that contribute to the Center. Projects and Centers addressing populations in US coastal and Great Lakes regions that will be more vulnerable to human health risks (e.g., those with existing health or social disparities) that are associated with or exacerbated by climate change are particularly encouraged.

COHH4 Goals and Structure

NIEHS and NSF will collaboratively support Centers that include a minimum of three research projects, a Community Engagement Core, and an Administrative Core. COHH4 awards are expected to create an environment conducive to interdisciplinary and reciprocally beneficial collaborations among biomedical scientists (e.g., epidemiologists, pharmacologists, toxicologists, microbiologists, cell and molecular biologists) and ocean scientists or limnologists (e.g., biological and physical oceanographers, geochemists, and ecologists) with the common goal of improving our knowledge of the impacts of the ocean and Great Lakes on human health.

The Center should include at least one project on human health and toxicity, and at least one project that uses oceanographic and marine science approaches to characterize oceans or Great Lakes exposures. A successful Center proposal is thus expected to include research projects collectively comprising fundamental research in each of these two broad categories and a plan for integrating them. Each project should describe distinct goals that are integrated into the overall theme of the Center. At least one of the three required projects should explore the influence of climate change on existing or emerging public health risks. Note, an individual project may include any or all of these elements.

In addition to a required Administrative Core, applicants may include a Facility Core to support relevant Center activities. Community Engagement Core projects should describe partnerships with community stakeholders and a plan for integrating activities with the proposed research projects under a unified theme.

This FOA requires a Plan for Enhancing Diverse Perspectives (PEDP) as part of the application (see further below). Applicants are strongly encouraged to read the FOA instructions carefully and view the available PEDP guidance material.

Program Description and Requirements

A. Research Projects

A Center proposal must include at least three research projects. Examples of possible research project topics are provided below. This list is not intended to be either prescriptive or complete.

Research projects that directly assess human exposures or investigate mechanisms of toxicity of ocean and Great Lakes exposure may include but are not limited to studies that:

  • Develop novel strategies to measure or estimate human exposure to aquatic toxins in the general population and/or particularly susceptible populations.
  • Examine the relationship among routes of exposure for emerging toxins (e.g. dermal, respiratory, ingestion) and health outcomes.
  • Focus on the role of OHH toxin exposure(s) in susceptibility to acute and chronic health outcomes across the lifespan.
  • Identify specific host biological pathways that interact with toxin exposure(s) and play a role in toxicity.
  • Address synergistic effects of chronic low-level exposure to environmental toxicants, including algal toxins, metals, endocrine disruptors, pharmaceuticals, pesticides, persistent organic pollutants, microplastics, and other toxicants that contaminate marine/lacustrine waters and seafood.
  • Develop new tools or models for interrogation of cellular systems relevant to oceans and human health.
  • Pursue the discovery of new toxins and the characterization and prioritization of unknown secondary metabolites.
  • Conduct research to define host absorption, distribution, metabolism, and elimination routes of toxins.

Research projects on ocean and Great Lakes observations and forecasting may include but are not limited to studies that:

  • Compare and correlate current observing systems, and/or evaluate the potential of newly developed sensors and systems for monitoring ocean and Great Lakes properties relevant to human health exposures.
  • Evaluate real-time, in-water observations of physicochemical properties, as well as the detection of HAB species and toxins.
  • Interrogate the relationships between environmental conditions and human exposures.
  • Determine strategies and standards for the incorporation of environmental observations in optimizing modeling and surveillance paradigms.
  • Develop predictive models for conditions that result in and/or enhance exposures.

Research projects on climate change may include but are not limited to studies that:

  • Interrogate how climate change directly and/or indirectly impacts toxic algal blooms, including their initiation, development, termination, toxin production, and other characteristics that influence the occurrence and severity of associated human disease.
  • Interrogate how temperature changes impact synergistic interactions among ocean-related toxins, chemicals, and waterborne pathogens also likely to be impacted by climate change.
  • Query how climate change and expansion in seasonal windows of growth as well as habitat range and migration of freshwater and marine toxin-producing algae will increase the risk of exposure to waterborne toxins.
  • Investigate how climate-driven changes in hydrology or circulation impact the distribution of and exposure to pollutants, toxins, or pathogens.
  • Query how increases in some extreme weather events and storm surge may decrease the efficacy of ecosystem mitigation or remediation efforts.

Community-engaged research projects mayinclude but are not limited to studies where community members collaborate with investigators to conduct research to:

  • Identify and evaluate health risks to specific subpopulations with increased exposure to waterborne toxins and chemical contaminants.
  • Identify situations where combined ocean or lake-related exposures and extreme weather events render subpopulations at a higher risk for disease or poor mental health outcomes.
  • Identify specific historical or traditional cultural practices that influence community members at risk from chemical contamination of seafood and develop risk messages that frame risk and interventions in culturally consonant terms.
  • Develop strategies for improved response to OHH exposure events and/or extreme weather events that threaten public health (e.g. improve training paradigms for first responders and healthcare practitioners, develop warning systems and educational materials, etc.).
  • Identify local impacts of seafood safety on food security and public health concerns.

B. Community Engagement Core (CEC)

Populations proximal to the coastline or Great Lakes may experience increased vulnerability to exposures based on existing health and social disparities, cultural practices, and/or reliance on the oceans or Great Lakes for subsistence, recreation, transportation, and commerce. Those who will face the greatest challenges to health risks from freshwater and marine aquatic sources include: pregnant women and women of child bearing age; children; the elderly, and those with existing co-morbidities or chronic disease(s), as well as populations/communities in low socioeconomic brackets. It is crucial for COHH4 to enact meaningful community engagement to protect public health and build coastal resilience.

The required Community Engagement Core (CEC) will establish and foster active partnerships with community organizations and community members, provide culturally appropriate and targeted translation of research findings to a variety of stakeholders, promote dialogue among investigators, community members and the general public, and build capacity in environmental health literacy and risk prevention.

The CEC is a critical bridge between the COHH4 and the relevant stakeholders that may have concerns about oceans and Great Lakes related environmental injustices. How each CEC is arranged will depend on the overall goals of the OHH Center, the proposed research, and the needs and capabilities of the stakeholders and of the applicant institution.

The goals of the CEC are to develop, implement, and advance: 1) strategies to strengthen the environmental health literacy of relevant stakeholders, the general public, policy-makers, and clinical professionals; 2) approaches to foster and sustain bi-directional dialogue between identified stakeholders and Center members for appropriate dissemination and implementation of scientific findings of the Center; 3) opportunities for community residents to participate in the full research continuum in collaboration with COHH4 research project leads; and 4) strategies to assess the effectiveness and impact of these activities in the community, and their contributions to the overall mission of the Center.

For approaches to plan and evaluate the CEC, see Partnerships for Environmental Public Health Evaluation Metrics Manual published by National Institute of Environmental Health Sciences at http://www.niehs.nih.gov/pephmetrics.

CEC activities must contribute to improvements within the community (broadly defined in collaboration with community representatives) and scientific advancements within the Center. Examples of community improvements include increased environmental health literacy, greater knowledge of environmental contributions to health disparities, and ways to recognize, prevent, reduce or eliminate them. Scientific advancements may include improved interventions based on local knowledge, improved cultural competency of Center members, and strengthened community-engaged research approaches.

Centers will be encouraged to submit all Center-produced community engagement materials to the NIEHS and NSF through the Partnerships for Environmental Public Health (PEPH) Resource Center while also sending them directly to program officers at NSF and NIEHS. The PEPH Resource Center was created by NIEHS to facilitate entry, archiving, management, viewing and downloading of educational and community engagement materials provided by NIEHS-funded public health investigators. The Resource Center fosters the sharing and exchange of materials between grantees, reducing duplication of effort while promoting the advancement of new communications strategies, as well as facilitating broader outreach to the environmental health research community, stakeholders and the public. NIEHS will facilitate access to Resource Center and will be responsible for managing and maintaining the repository and facilitating community engagement efforts.

C. Administrative Core

The administrative structure should include a Center Director, a Co-Director, a business manager, an internal steering committee, and an external advisory committee (EAC). The Director and Co-Director should possess complementary expertise in biomedical and oceanographic sciences. An individual with expertise in either field can be Director or Co-Director. The EAC should consist of a group of three to five scientists with expertise appropriate for the Center's research focus, who are outside the applicant institution. Note, names of potential EAC members should not be solicited or submitted in the application itself.

The administrative core should promote joint planning and evaluation activities as well as collaborations and interactions among different components of the Center. The Center must have appropriate and adequate management capabilities to conduct research and to evaluate the performance of the Center in achieving the goals of the FOA. As a requirement of this FOA, the Administrative Core is responsible for evaluating the impact of the science conducted by each Center in elucidating connections between the oceans and human health.

D. Facility Cores

Centers may support shared core resources common to two or more research projects. Each Center may support facility cores that provide a technique, service, or instrumentation to enhance ongoing research efforts. Examples of such facilities include: biostatistics and/or bioinformatics, genomics and proteomics, exposure assessment, and sensor development. Although the core service will be budgeted for COHH projects, research projects external to the Center may have paid access to facility cores.

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

Applications must include a Plan for Enhancing Diverse Perspectives (PEDP) submitted as Other Project Information as an attachment (see Section IV). The PEDP will be assessed as part of the scientific and technical peer review evaluation, as well as considered among programmatic matters with respect to funding decisions.

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

Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs.

Section II. Award Information

Funding Instrument

Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed
New
Renewal (Applications submitted under RFA-ES-16-009)
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?

Optional: Accepting applications that either propose or do not propose clinical trial(s).

Funds Available and Anticipated Number of Awards

NIEHS and NSF intend to commit up to $8.5 million per year to fund 6 awards.

Award Budget

Application budgets may not exceed $950,000 per year in direct costs.

Award Project Period

The maximum project period for an application submitted in response to this funding opportunity may not exceed 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)

Federal Governments

  • Eligible Agencies of the Federal Government
  • U.S. Territory or Possession
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 not 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.

  • System for Award Management (SAM) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
    • NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
    • Unique Entity Identifier (UEI) - A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
  • eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their full SAM and Grants.gov registrations; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
  • Grants.gov – Applicants must have an active SAM registration in order to complete the Grants.gov registration.

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

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

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

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 or an institutional system-to-system solution. A button to apply using ASSIST is 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 Multi-Project (M) Instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Letter of Intent

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

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

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

The letter of intent should be sent to:

Linda K. Bass, Ph.D.
Telephone: 984-287-3236
Fax: 919-316-4606
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.

Component Component Type for Submission Page Limit Required/Optional Minimum Maximum
Overall Overall 12 Required 1 1
Admin Core Admin Core 12 Required 1 1
Community Engagement Core - CEC CEC 6 Required 1 1
Facility Service Core - FSC FSC 6 Optional 0 1
Research Project Project 12 each Required 3 4

Instructions for the Submission of Multi-Component Applications

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

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

The application should consist of the following components:

  • Overall: required
  • Administrative Core: required
  • Community Engagement Core (CEC): required
  • Facility/Service Core (FSC): optional
  • Research Projects: required: minimum of 3; maximum of 4

Overall Component

When preparing your application, use Component Type ‘Overall’.

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

SF424(R&R) Cover (Overall)

Complete entire form.

PHS 398 Cover Page Supplement (Overall)

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

Research & Related Other Project Information (Overall)

Follow standard instructions.

Other Attachments:

Plan for Enhancing Diverse Perspectives (PEDP)

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

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

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

Project/Performance Site Locations (Overall)

Enter primary site only.

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

Research and Related Senior/Key Person Profile (Overall)

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

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

Budget (Overall)

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

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

PHS 398 Research Plan (Overall)

Specific Aims: Specific aims should be built around serving the goals of the Center.

Research Strategy: Applicants must propose an overall research theme and plan that are responsive to the objectives of the NIEHS and NSF's Centers for Oceans and Human Health Program. The central scientific theme should be related to the role of the oceans or Great Lakes and climate change in the context of adverse human health outcomes.

The program overview section describes the significance, innovation and approach of the overall application and should highlight the program's conceptual unity by describing the scientific problems to be addressed and laying out a broad research strategy to address them. A Center should be viewed as a group of interrelated research projects, each of which is not only individually meritorious scientifically but also complementary to and interrelated with the other projects in the research program that contribute to the integrating theme. The theme of a proposed Center should be established in the first few sentences of this section. It should include a description of the major research objectives and strategic plan. Explain how the proposed projects and shared resource cores (if proposed) will be coordinated and work together to address the overall goals and aims of the program more effectively than if the projects were conducted independently. It should include an explanation of how the goals of the Community Engagement Core and community partnerships complement the scientific goals of the Center.

Letters of Support: Letters of support for the P01 overall should be included with the Overall Component. For program activities to be conducted off site, i.e., at an institution other than the applicant institution, a letter of assurance or comparable documentation, signed by the collaborator as well as the off-site institutional official, must be submitted with the application.

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 Center 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. This includes facilitation of data sharing with other Centers, federal researchers, the public, and community partners.
    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 items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Overall)

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

If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, there must be at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record within the application. The study record(s) must be included in the component(s) where the work is being done, unless the same study spans multiple components. To avoid the creation of duplicate study records, a single study record with sufficient information for all involved components must be included in the Overall component when the same study spans multiple components.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.

PHS Assignment Request Form (Overall)

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

Administrative Core  

When preparing your application, use Component Type ‘Admin Core’.

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

SF424 (R&R) Cover (Administrative Core)

Complete only the following fields:

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

PHS 398 Cover Page Supplement (Administrative Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Administrative Core)

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

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

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

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

List all performance sites that apply to the specific component.

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

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

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

Budget (Administrative Core)

Budget forms appropriate for the specific component will be included in the application package. Each Center must budget to support travel costs to COHH4 Annual Meetings in venues to be determined in collaboration with the Center Investigators and NIEHS and NSF program staff. Travel costs for the annual 1-2 day meetings should support at a minimum the Director(s), Project Investigators and CEC Director. Each COHH4 should expect to host such a meeting once within the project period and may want to set funds aside for the event. Please consult with program staff for details. It is anticipated that a Center will devote no more than 10 percent of its budget to the administrative core.

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

PEDP implementation costs:

PHS 398 Research Plan (Administrative Core)

Specific Aims: State the aims for the Administrative Core.

Research Strategy: The Administrative Core is to provide oversight, coordination, and integration of Center activities. An External Advisory Committee (EAC) to the Center Director should be established and managed as part of the Administrative Core. The function of the EAC is to assist in evaluating the merit, value and ongoing progress of each research project and the relevance and importance of individual organizational elements to accomplish the overall goals of the Center. This group should consist of three to five members with expertise appropriate for the Center's research focus, plus one representative from a community group. Representation from a state or local health department is also encouraged. At least two-thirds (67 percent) of the Committee members should be from outside the grantee institution. The EAC should meet at least twice within the first four years of the grant, and NIEHS and NSF staff should be notified of the meeting and invited to attend. The written recommendations of the EAC should be provided as part of the annual progress report. Names of potential EAC members should not be solicited or submitted in the application. Instead, a description of proposed protocols and planned committee by representation and area of expertise should be submitted. If awarded, the PD/PI will be asked to provide names of EAC members to the funding agencies.

It is expected that organization of the Administrative Core will provide a supportive structure sufficient to ensure accomplishment of the following:

  • Coordination and integration of COHH4 components and activities.
  • Assessment of productivity, effectiveness, and appropriateness of COHH4 activities to fulfill Center goals and promote collaboration among all COHH4 members.
  • Organization of COHH4 activities, invitation of consultants, meetings, and focus groups.
  • Organization and management of the External Advisory Committee.
  • Record keeping of meeting minutes and measures of success including: publications, supplemental research projects, mentoring of new scientists, new grant applications and awards generated from Center results or scientific inquiry.
  • Facilitation of interactions and collaborations with other CECs, NIEHS, NSF, and other appropriate individuals, groups, or organizations that promote and support oceans, Great Lakes, and human health.
  • Compliance of the components according to the expectations outlined in the overall and respective Resource and Data Sharing Plans.
  • Execution of key elements described in the PEDP: processes to include elements, such as recruitment strategies, career development and mentoring opportunities, outreach and partnering with advocacy groups, and other strategies to advance inclusivity in alignment with the program goals.

A successful COHH4 application will include a well-integrated project plan. Within the Administrative Core, the specific administrative and organizational structure that is needed to support the research and the synergies enabled by the Center needs to be clearly articulated. COHH4 projects will be multidisciplinary and interdisciplinary and will draw from a variety of resources. Thus, a well thought out and carefully described organizational structure is encouraged to enable the oversight of fiscal and resource management, including the approach, procedures, and controls for ensuring that awarded grant funds will be expended in a timely and efficient manner.

A narrative description should be provided that includes the planning and coordination of research activities; the integration of cross-disciplinary research; and the tracking of progress towards Center outputs and outcomes.

For guidance on evaluation, applicants are encouraged to review the PEPH Evaluation Metrics Manual at http://www.niehs.nih.gov/pephmetrics.

Details about how Center objectives will be successfully achieved within the project period should be described. A plan for maintenance of ongoing communication with NIEHS and NSF should also be provided. Indicate who will be responsible for each of these activities. Describe the involvement of advisory groups and consultants.

Describe how the Administrative Core will coordinate the research activities with existing resources, activities or programs at the institution, including training opportunities.

Letters of Support: Include letters of support for any collaborative/cooperative arrangements, subcontracts, or consultants.

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

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 Center and any accompanying metadata will be managed, preserved, and shared, taking into account any potential restrictions or limitations. The Data Sharing Plan for the administrative core should outline a strategy to ensure the compliance with the stated objectives for sharing data with the research community, the public, and community partners. 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. This includes facilitation of data sharing with other Centers, federal researchers, the public, and community partners.

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 items are allowed in the Appendix.Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Administrative Core)

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.

Community Engagement Core

When preparing your application, use Component Type ‘CEC.’

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

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

Complete only the following fields:

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

PHS 398 Cover Page Supplement (Community Engagement Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Community Engagement Core)

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

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

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

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

List all performance sites that apply to the specific component.

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

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

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

Budget (Community Engagement Core)

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

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

PHS 398 Research Plan (Community Engagement Core)

Specific Aims:State the aims for the Community Engagement Core.

Research Strategy: The applicant should describe how this Core will help develop and sustain community outreach, engagement, and translation activities at the Center. The CEC promotes multi-directional communication among the Center and its stated target audiences on issues of prevention, environmental health literacy, and environmental public health. To this end, the CEC should develop, demonstrate, and evaluate strategies to translate and apply the scientific findings of the Center into information for community partners, the public, policymakers, and clinical professionals. In addition, the CEC should describe a variety of mechanisms to be used to facilitate and enable community partners to communicate marine, Great Lakes, and climate-related health concerns to Center members. These may include, for example, the creation of translational materials for health professions, development of novel strategies for dissemination of research findings to the broad audience of stakeholders, and assessment of community understanding of research results and plans for action. This section should include description of:

  • A plan to collect, integrate and disseminate research findings and Center activities for the public, community partners, policy makers, and clinical professionals to use to protect the health of at-risk populations.
  • The membership of the CEC and types of expertise to be recruited to enhance effective communication strategies and improve engagement with communities experiencing environmental injustice along the coast or in the Great Lakes Basin.
  • The type of innovative methods that may be used to enhance CEC activities including ways of interacting with stakeholders or identified end-users of materials.
  • How the CEC investigators will be able to assess the effectiveness of their developed products.
  • How the CEC will interact with Center investigators and the Administrative Core to develop materials and assist with the overall goals of the Center.
  • How the CEC will develop, enhance, and ensure a productive working relationship between the community and the Center's researchers.

All proposed activities must include an evaluation plan to assess the effectiveness and/or efficacy of the activities. For approaches to plan and evaluate the CEC, see Partnerships for Environmental Public Health Evaluation Metrics Manual published by National Institute of Environmental Health Sciences at http://www.niehs.nih.gov/research/supported/dert/sphb/programs/peph/metrics/index.cfm.

Letters of Support: Include letters of support where appropriate to demonstrate collaborations, access to resources, institutional commitment, etc.

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

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Community Engagement Core)

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.

Facility/Service Core

’When preparing your application, use Component Type 'FSC'.

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

SF424 (R&R) Cover (Facility/Service Core)

Complete only the following fields:

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

PHS 398 Cover Page Supplement (Facility/Service Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research &Related Other Project Information (Facility/Service Core)

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

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

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

Project /Performance Site Location(s) (Facility/Service Core)

List all performance sites that apply to the specific component.

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

Research & Related Senior/Key Person Profile (Facility/Service Core)

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

Budget (Facility/Service Core)

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

The application should provide a total operational budget for the core together with percentage of support requested by the Center grant.

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

PHS 398 Research Plan (Facility/Service Core)

Specific Aims: State the specific aims of the Facility/Service Core.

Research Strategy: Each Center is encouraged to make use of existing Core services and resources available through their institution. New Cores should be proposed only if they are not available through existing services or facilities. Each new Core proposed must serve at least two research projects and provide a technique, service, or instrumentation that will enhance ongoing research efforts. Describe the function of the core as a resource to the program. This section must clearly present the facilities, techniques, and professional skills that the core will provide. As justification for the core, briefly indicate the specific Research Projects that will use the resources of the core. A Facility/Service Core is principally designed as a service or resource component; it would be highly unusual to include research in a core (a possible exception would be methodology development).

Describe the role of the core as a resource to the Center as a whole. Discuss ways in which these centralized services will produce an economy of effort and/or savings in overall costs compared to their inclusion as part of each research project. To aid in the review of the application, it is recommended that the application include, in tabular form, information concerning the research projects that each facility core unit would serve and the proportion of the cost of the facility core unit associated with each research project involved.

Letters of Support: Include letters of support where appropriate to demonstrate collaborations, access to resources, institutional commitment, etc.

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

Appendix:

Only limited items are allowed in the Appendix.Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Facility/Service Core)

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.

Research Projects

When preparing your application, use Component Type ‘Project.’

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

SF424 (R&R) Cover (Research Projects)

Complete only the following fields:

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

PHS 398 Cover Page Supplement (Research Projects)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Research Projects)

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

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

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

Project /Performance Site Location(s) (Research Projects)

List all performance sites that apply to the specific component.

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

Research & Related Senior/Key Person Profile (Research Projects)

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

Budget (Research Projects)

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

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

PHS 398 Research Plan (Research Projects)

Specific Aims:State the aims for the project. Specific aims should be built around serving the goals of the overall program.

Research Strategy: The Research Project must be pertinent to the central goal of the program.

The Research Project should represent both a separate and an interdependent research effort. The benefits associated with being part of the program project must also be addressed.

Letters of Support: Include letters of support where appropriate to demonstrate collaborations, access to resources, institutional commitment, etc.

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

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. This includes facilitation of data sharing with other Centers, federal researchers, the public, and community partners.

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 items are allowed in the Appendix.Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Research Projects)

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.

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

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

4. Submission Dates and Times

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

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies) using ASSIST or other electronic submission systems. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

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

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

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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

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

7. Other Submission Requirements and Information

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

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

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

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

Important reminders:

All PD(s)/PI(s) and component Project Leads must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile form. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.

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, NIH. Applications that are incomplete or non-compliant will not be reviewed.

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

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

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.

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

Overall Impact - Overall

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the Center 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 Center proposed).

Scored Review Criteria - Overall

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?

To what extent do the efforts described in the Plan for Enhancing Diverse Perspectives further the significance of the project?

In addition, for applications involving clinical trials

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

Investigator(s)

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

To what extent will the efforts described in the Plan for Enhancing Diverse Perspectives strengthen and enhance the expertise required for the project?

In addition, for applications involving clinical trials

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

Innovation

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

To what extent will the efforts described in the Plan for Enhancing Diverse Perspectives meaningfully contribute to innovation?

In addition, for applications involving clinical trials

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

Approach

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

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

Are the timeline and milestones associated with the Plan for Enhancing Diverse Perspectives well-developed and feasible?

In addition, for applications involving clinical trials

Does the application adequately address the following, if applicable

Study Design

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

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

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

Data Management and Statistical Analysis

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

Environment

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

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

In addition, for applications involving clinical trials

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

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

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

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

Additional Review Criteria - Overall

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.

Center

  • Does the Center consist of a cohesive and multidisciplinary focus? Does a coordinated interrelationship exist between the research projects and cores? Are the components of the Center related to the common theme of the Center?
  • What is the scientific gain of combining the component parts into a Center?
  • Will the specific scientific objectives of each project benefit significantly from, or depend upon collaborative interactions with other projects in the program (i.e., objectives that can be uniquely accomplished, specific contributions to the accomplishments of objectives in other projects, objectives that can be accomplished with greater effectiveness and/or economy of effort, etc.)?

Data Sharing Pan

  • Does the plan describe a strategy for oversight of data management and sharing?
  • Does the plan describe the approach and timeline for managing, preserving and sharing data over the course of the projects?

Review Criteria - Administrative Core:

Reviewers will consider each of the review below in the determination of the merit of the Core, and give a score based on the described criteria.

  • Are the objectives of the Administrative Core appropriate to the Center?
  • Do the Administrative Core objectives reflect the interdisciplinary nature of the Center? Are interactions among projects, cores, and external partners/communities evident? Does the Center’s internal plan promote coordination of interdisciplinary research and stimulate collaborations among components, particularly with regard to biomedical or toxicology and ocean science project interactions?
  • Is there evidence that the lines of authority and the administrative structure are designed for effective management and leadership of the Center? Does the senior leadership have appropriate experience, and have they demonstrated effective and responsible leadership in the past?
  • Is there a decision-making process for the management of funds and resources? Is there evidence of an ability to provide administrative support to the project and core leaders?
  • Is there an appropriate plan to establish and use an external advisory committee with appropriate expertise?
  • For the activities proposed, is the percent effort requested adequate? Are the qualifications, duties and time commitments of administrative staff appropriate to contribute to the needs and conduct of the Center’s research activities? Is the institutional commitment adequate? Is there evidence of support or cooperation between multiple institutional departments, as applicable?
  • Is the role of the Co-Director appropriate for the Administrative Core and does their expertise contribute to the Center?
  • Is there a plan to ensure Center compliance with the overall and individual component resource and data sharing plans?

Review Criteria - Facility/Service Core (if applicable):

Reviewers will consider each of the criteria below in the determination of the merit of the Core, and give a score based on the described criteria.

  • Are the objectives of the Facility Core(s) appropriate to the Center? Are the approaches and methods proposed adequate to achieve objectives?
  • Does the Facility Core promote and/or enhance interactions among the Center components? Does the Facility Core provide essential facilities or service for two or more of the research projects? Is the projected use sufficient to warrant establishment of the Facility Core?
  • Are the Facility Core resources contributing to the overall research activities of the Center? Is there evidence of enhanced efficiencies (including cost) afforded by the core?
  • Is the Quality Assurance Statement for cores providing quantitative analyses adequate?
  • Is there a prioritization plan for use of Facility Core services?
  • Does the staff have the appropriate experience and level of commitment? Does the Facility Core contribute scientifically to the proposed Center’s problem-solving goals (i.e., the importance of the ideas or aims, the rationale and originality of the approach, the feasibility of the methods, and the value of the result)?

Review Criteria - Community Engagement Core (CEC):

Reviewers will consider each of the review criteria below in the determination of the merit of the Core, and give a score based on the described criteria.

  • Is the community of interest clearly defined? Is there evidence of the community's acceptance as a partner in the core?
  • Are the community's and academic partners' roles clearly described? Is the community an integral part of the activity?
  • Does the CEC highlight specific and appropriate prevention and/or intervention activities tailored to fit the overall goals of the Center and complement the Center’s research?
  • Is the approach appropriate according to community socioeconomic and cultural factors?
  • Are the objectives of the CEC of high priority to the community?
  • Will the CEC lead to a mutually-beneficial, bidirectional relationship between the academic institution and the community?
  • Does the management plan adequately describe a process for maintaining transparent communications between the community and the academic partners throughout the entire process of the activity?
  • Does the plan address methods of building and sustaining community partnerships and participation?
  • Does the investigator provide previous experience/evidence for conducting community engagement activities?
  • Does the research environment enhance the likelihood of success?

Review Criteria - Individual Research Projects

Scored Review Criteria - Projects

Reviewers will consider each of the criteria below in the determination of scientific merit, and give a separate score for each. A project does not need to be strong in all categories to be judged likely to have major scientific impact.

Significance

Does the project address an important problem or a critical barrier to progress in the field? Is there a strong scientific premise for the project? 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?

Investigator(s)

Are the Project Leads, collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or 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 Project Lead, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

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?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the 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 children, justified in terms of the scientific goals and research strategy proposed?

Environment

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

Additional Review Criteria - Projects

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

A Data Sharing Plan for each project should describe the approach for how scientific data and accompanying metadata generated from the proposed project will be managed, preserved, and shared.

  • Does the plan describe the approach for managing, preserving and sharing data over the course of the project?
  • Does the plan describe tools, software and/or code needed to interpret the data?
  • Does the plan describe standards to be applied to the scientific data and associated metadata?

If the Research Project includes community engaged research, then the following criteria will be included in the evaluation:

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

Study Timeline

Specific to applications involving clinical trials

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

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

Protections for Human Subjects

For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Individuals Across the Lifespan

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate 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 Renewals, the committee will consider the progress made in the last funding period.

  • Has sufficient progress been made in the last funding period relative to the original goals of the Center and objectives of each Research Project and Cores?
  • Does progress made during the previous funding period demonstrate an acceptable level of integration among the Research Projects and Cores?
  • Were the previous specific aims accomplished, and are the proposed research goals logical extensions of work during the current funding period?
  • Has scientific synergy occurred, as indicated by joint publications and new collaborative aims and/or projects?
  • Has the Center demonstrated impactful engagement with community partners?
  • Is there adequate justification for adding or deleting new Research Projects and/or Cores?

Revisions

Not Applicable

Additional Review Considerations - Overall

As applicable for the Centerproposed, 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)  (2) Sharing Model Organisms; and (3) 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, 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:

  • 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 including the PEDP.

3. Anticipated Announcement and Award Dates

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

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

Section VI. Award Administration Information

1. Award Notices

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

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

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

Any application awarded in response to this 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.

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

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

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

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

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

Prior Approval of Pilot Projects

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

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: Generaland 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 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 (including gender identity, sexual orientation, and pregnancy). This includes ensuring programs are accessible to persons with limited English proficiency and persons with disabilities. 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 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.

Recipients of FFA must ensure that their programs are accessible to persons with limited English proficiency. For guidance on meeting the legal obligation to take reasonable steps to ensure meaningful access to programs or activities by limited English proficient individuals see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.htmlandhttps://www.lep.gov.

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

Not Applicable

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 the threshold. See the NIH Grants Policy Statement for additional information on this reporting requirement.

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

Section VII. Agency Contacts

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

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)

Anika L. Dzierlenga, PhD
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 984-287-3125
Email: anika.dzierlenga@nih.gov

Henrietta N. Edmonds, PhD
National Science Foundation (NSF)
Telephone: 703-292-7247
Email: hedmonds@NSF.gov

Peer Review Contact(s)

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

Financial/Grants Management Contact(s)

Michelle Victalino
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 984-287-3336
Email: victalino.@niehs.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 and 45 CFR Part 75 and 2 CFR Part 200.

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