NIH’s new Application Submission System & Interface for Submission Tracking (ASSIST) is available for the electronic preparation and submission of multi-project applications through Grants.gov to NIH. Applications to this FOA must be submitted electronically using ASSIST or an institutional system-to-system solution; paper applications will not be accepted. ASSIST replaces the Grants.gov downloadable forms currently used with most NIH opportunities and provides many features to enable electronic multi-project application submission and improve data quality, including: pre-population of organization and PD/PI data, pre-submission validation of many agency business rules and the generation of data summaries in the application image used for review.

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) and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. 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.

Part 1. Overview Information
Part 2. Full Text of the Announcement

Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Climate change is recognized as one of the most important emerging public health challenges in the coming decades. The specific impacts of climate change on marine and lacustrine environments, including rising water temperatures, rising sea levels, and possible increases in the frequency and duration of severe weather events, are already being observed, as are the effects of these impacts on coastal populations, in the Great Lakes basin and other lacustrine environments. Unprecedented 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 NIEHS are jointly releasing this FOA 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 NIEHS and NSF previously released three collaborative Funding Opportunity Announcements to support Oceans and Human Health and the Great Lakes and Human Health, (RFA-ES-03-003, RFA-ES-11-012 and RFA-ES-11-013) that fostered collaborations between investigators with expertise in biomedical disciplines and the ocean sciences. RFA-ES-03-003 solicited P50 applications that supported three research focal areas: Harmful Algal Blooms (HABs); vector and water-borne pathogens; and Marine Natural Products. RFA-ES-11-012 supported P01 program projects using multi-disciplinary approaches to study HABs and marine pollution. RFA-ES-11-013 supported both R01 and P01 projects, focused on HAB research and pollution, featured an expanded scope to include Great Lakes Basin environments and considered aspects of climate change impacts on both marine and Great Lakes environments. The current initiative will continue support of these scientific themes with an added focus on how climate change impacts environmental health risks related to water bodies.

The scope and diversity of climate change effects on ocean ecosystems and those in the Great Lakes Basin dictate the focus of this new Centers for Oceans and Human Health collaborative program- to support research on how climate change is impacting public health risks associated with these exposures, especially on the vulnerable populations that are at increased risk. The scope of research solicited by this new program spans studies to (1) identify relationships among parameters of climate change and alterations in sediment and coastal pollutant deposition and increased human exposure to toxins and waterborne pathogens; (2) determine impacts of climate change on increasing incidence of harmful algal bloom (HAB) events; (3) understand mechanisms of toxicity underlying health impacts linked to climate change; (4) 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; (5) address populations in US coastal and Great Lakes regions (e.g., those with existing health or social disparities) that will be more vulnerable to human health risks that are associated with or exacerbated by climate change; and (6) engage communities in collaborative activities with Center investigators.

NIEHS and NSF will collaboratively support centers that include a minimum of three research projects, a community engagement core, and an administrative core. Successful applications will include a focus on climate change impacts that may be addressed by aims within research projects that specifically explore how climate change will exacerbate existing public health risks or address emerging risks solely attributable to climate change. COHH3 awards are expected to create an environment conducive for interdisciplinary and reciprocally beneficial collaborations among biomedical scientists (e.g., epidemiologists, pharmacologists, toxicologists, microbiologists, cell and molecular biologists) and ocean scientists (e.g., biological and physical oceanographers, geochemists, and ecologists) or limnologists with the common goal of improving our knowledge of the impacts of the ocean and Great Lakes on human health. In addition to a required administrative core, applicants may include Facility Cores to support relevant Center activities.

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

• May interrogate how climate change directly and/or indirectly impacts toxic algal blooms, including their initiation, development, termination, and other characteristics that influence the occurrence and severity of associated human disease.
• May interrogate how temperature changes impact synergistic interactions among ocean-related toxins, chemicals, and waterborne pathogens also likely to be impacted by climate change, and how changes in climate impact these relationships.
• May query how climate change and expansion in seasonal windows of growth as well as habitat range for freshwater and marine toxin-producing algae will increase the risk of exposure to waterborne toxins.
• May query how increases in some extreme weather events and storm surge may increase the risk of failure of, or damage to, water infrastructure for drinking water, wastewater, and stormwater. A breakdown in water infrastructure would contribute to increased risk of exposure to water-related pathogens, chemicals, and algal toxins.

Research projects on toxins and mechanisms of toxicity may include but are not limited to studies that:

• May focus on effects of OHH toxin exposure(s) on susceptibility to chronic disease, e.g. heart failure, kidney disease, diabetes, etc.
• May address synergistic effects of chronic low level exposure to multiple environmental toxicants, e.g., algal toxins, metals, endocrine disruptors, pharmaceuticals, Persistent Organic Pollutants, and any OHH related toxicants that contaminate marine/lacustrine waters and seafood.
• May examine relationships between diseases and neurotoxins in fish and those coming from harmful algal blooms. The relationship between incidence of the disease and exposure via ingestion or inhalation to these toxins is an area of currently emerging research.
• May develop new tools for interrogation of cellular systems relevant to oceans and human health.
• May develop clinical tests for algal toxin exposure.
• May pursue the discovery of new toxins as there are several gene clusters in Microcystis that produce unknown secondary metabolites.
• May evaluate the uptake, bioaccumulation and depuration of microplastics by commercially important aquatic species; research should focus on chronic exposure and strive to understand the biological processes that contribute to encounter, ingestion, and elimination.

Research projects on the development of enhanced monitoring/forecasting may include but are not limited to studies that:

• May compare and correlate current observing systems for monitoring ocean and Great Lakes properties including Harmful Algal Blooms.
• May evaluate long term field application potential of newly developing in situ sensors for monitoring ocean and Great Lakes properties.
• May evaluate real-time, in-water observations of physicochemical properties, as well as the detection of HAB species and toxins, to provide data streams for assimilation by predictive models.
• May develop appropriate and efficient monitoring strategies for algal toxins (particularly in drinking water) that are protective of public health.

Research projects on seafood safety may include but are not limited to studies that:

• May identify health effects related to toxic metals in seafood including speciation and exposure to inorganic arsenic.
• May determine how climate change may alter the patterns or magnitude of chemical contamination of seafood, leading to altered effects on human health. Changes in hydrology resulting from climate change are expected to alter releases of chemical contaminants into the nation’s surface waters, with as yet unknown effects on seafood contamination.

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

• May identify and evaluate health risks to specific subpopulations associated with waterborne toxins and climate-change induced increases in the release and mobilization of these chemical contaminants.
• May identify specific subpopulations at highest risk of climate change related exposures, for example based on occupational or recreational activities, and assess the prevalence or change in prevalence of chronic disease such as heart failure, kidney disease, diabetes, in these populations attributable to climate change.
• May 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.
• May assess the scientific and environmental health literacy of coastal communities exposed to HABs, other ocean-related toxins, chemicals, and waterborne pathogens and develop risk messages based on the scientific findings that are geared to specific audiences with varying levels of scientific and health literacy and English language proficiency.
• May participate in monitoring, collection and analysis of seafood and water to determine seafood safety and water quality in their communities. Building the capacity of community partners will foster sustainability of projects beyond the project term.

There are a number of stakeholders involved in oceans/Great Lakes and human health research. Chief among them are the populations at risk due to proximity to the coastline, increased vulnerability 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 SES brackets.

The required Community Engagement Core (CEC) will oversee engagement of community organizations and community members, provide culturally appropriate and targeted translation of research findings to a variety of stakeholders, promote dialogue between 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 COHH and the relevant stakeholders that may have concerns about the increasing environmental impacts on health disparities. 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) provide opportunities for community residents so that they may participate in the full research spectrum, in particular the design, conduct, and communication of community-engaged health disparity interventions; and 4) strategies to assess the effectiveness of these activities 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 NIH and NSF through the Partnerships for Environmental Public Health (PEPH) Resource Center while also sending them directly to program officers at NSF and NIH. 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, stake holders 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.

The administrative structure should include a Center Director, a Co-Director, a business manager, an internal steering committee, and an external advisory committee. 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. Both fields should be covered by the Director and Co-Director team. The external advisory committee (EAC) should consist of a group of three to five scientists, having expertise appropriate for the Center's research focus, who are outside the applicant institution. .

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. 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 are required as part of this core.

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. Budgeted Center projects as well as research projects external to the Center may have access to facility cores.

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

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

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)

Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)
• Eligible Agencies of the Federal Government
• U.S. Territory or Possession

Other

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

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

• Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
• System for Award Management (SAM) (formerly CCR) 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.
• eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

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

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

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

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.

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

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. 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 NOT-OD-11-101).

A button to access the online ASSIST system 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.

Most applicants will use NIH’s ASSIST system to prepare and submit applications through Grants.gov to NIH. Applications prepared and submitted using applicant systems capable of submitting electronic multi-project applications to Grants.gov will also be accepted.

It is critical that applicants follow the Multi-Project (M) Instructions in the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions 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.

For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

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: 919-541-1307
Fax: 919-316-4606
Email: [email protected]

Component Types Available in ASSIST	Research Strategy/Program Plan Page Limits
Overall	12 pages
Admin Core	12 pages
Core [Use for: -Community Engagement Core (CEC)] -Facility/Service Core (FSC)]	6 pages
Project (use for each Research Project)	12 pages

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

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

The application should consist of the following components:

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

When preparing your application in ASSIST, use Component Type Overall .

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

Complete entire form.

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

Follow standard instructions.

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.

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.

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.

Specific Aims: Specific aims should be built around serving the goals of the program project

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.

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, with the following modification:

All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan. The plan should include the following items:

• Statement of the investigator's commitment to share data;
• Description of the data to be produced;
• Standards to be used for collected data and metadata;
• Mechanisms for providing access to/sharing data;
• Description of tools, including software, needed to access and/or interpret the data;
• Milestones and timelines for making the data publicly accessible;
• Provisions for reuse and redistribution of the data.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

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

When preparing your application in ASSIST, use Component Type Admin Core.

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

Complete only the following fields:

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

Enter Human Embryonic Stem Cells in each relevant component.

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.

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.

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Core 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.

Each Center must budget to support travel costs to COHH3 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, Project Investigators and CEC Director (when applicable). Each COHH3 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.

Specific Aims: State the aims for the Administrative Core.

Research Strategy: The Administrative Core is to provide oversight, coordination, and integration of Center activities. Unless otherwise performed by the CEC, the Administrative Core should coordinate community engagement and facilitate meaningful exchange between Center investigators, the community, and stakeholders.

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 having 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 over the life 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 an identifiable list of membership to the EAC 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 COHH3 components and activities.
• Assessment of productivity, effectiveness, and appropriateness of COHH3 activities and determination of COHH3 membership assessment of scientific opportunities and areas for collaboration among all COHH3 members.
• Organization of COHH3 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.
• Interactions and collaborations with other CECs, NIEHS, EPA and other appropriate individuals, groups, or organizations that promote and support children's environmental health.

A successful COHH3 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. COHH3 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.

Details about how project 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. No specific funds should be used to develop new training programs or to directly support existing training programs; however, a listing of available resources to recruit new investigators should be provided. A plan for tracking the impact of CEC on investigator development should be described.

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:

Each Center for Oceans and Human Health 3 application is expected to include a data sharing plan to facilitate data sharing with other Centers, federal researchers, the public and key stake holders. Applicants are expected to provide a plan to make all data resulting from an agreement under this FOA available in a format and with documentation/metadata such that they may be used by others in the scientific community. This includes data first produced under the award, i.e., from observations, analyses, or model development collected or used under the agreement. Applicants who plan to develop or enhance databases containing proprietary or restricted information are expected to provide, within the two pages, a strategy to make the data widely available, while protecting privacy or property rights. In addition, each Center is expected to describe a mechanism for data sharing and technology transfer with other Centers and with potential end users of research results, such as state public health and environment agencies.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

PHS Inclusion Enrollment Report (Administrative Core)

When conducting clinical research, follow all instructions for completing PHS Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

When preparing your application in ASSIST, use Component Type Core.

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 the public, policymakers, and clinical professionals to use to protect the health of children. In addition, the CEC should describe a variety of mechanisms to be used to facilitate and enable the community/stakeholders to communicate environmental 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.

• Describe a plan to collect, integrate and disseminate research findings and Centers activities for the public, policy makers, and clinical professionals to use to protect the health of at risk populations.
• Describe the membership of the CEC and types of expertise to be recruited to enhance effective communication strategies.
• Describe 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.
• Describe plans of how the CEC investigators will be able to access the effectiveness of their developed products and whenever possible.
• Describe how the CEC will interact with Center investigators and the Administrative Core to develop materials and assist with the overall goals of the Center.
• Describe 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.

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: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

PHS Inclusion Enrollment Report (Community Engagement Core)

When conducting clinical research, follow all instructions for completing PHS Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

When preparing your application in ASSIST, use Component Type Core.

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 program 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 project in the program. 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: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

PHS Inclusion Enrollment Report (Facility/Service Core)

Not Applicable

When preparing your application in ASSIST, 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 Projects)

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 program project.

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:

Each COHH3 application is expected to include a data sharing plan to facilitate data sharing with other Centers, federal researchers, the public and key stake holders. Applicants are expected to provide a plan to make all data resulting from an agreement under this FOA available in a format and with documentation/metadata such that they may be used by others in the scientific community. This includes data first produced under the award, i.e., from observations, analyses, or model development collected or used under the agreement. Applicants who plan to develop or enhance databases containing proprietary or restricted information are expected to provide, within the two pages, a strategy to make the data widely available, while protecting privacy or property rights.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

PHS Inclusion Enrollment Report (Research Projects)

When conducting clinical research, follow all instructions for completing PHS Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

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

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

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies) 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.

This initiative is not subject to intergovernmental review.

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

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

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

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 Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. 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 Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

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

See more tips for avoiding common errors.

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

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

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

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

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 Center t that by its nature is not innovative may be essential to advance a field.

Does the Center 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 Center 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?

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the Center ? 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 multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

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?

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the Center? 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 Center 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?

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?

As applicable for the Center 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.)?

Does the project have the potential to benefit society and contribute to the achievement of specific, desired societal outcomes?

Reviewers will consider each of the review 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?

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.

Community-Engaged Research

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

Are the 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?

For research that involves human subjects but does not involve one of the six 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 six 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.

When the proposed Center 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 children 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.

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.

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.

Not Applicable

Not Applicable

Not Applicable

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

Not Applicable

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).

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genomic Data Sharing Plan .

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.

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

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), convened by the National Institute of Environmental Health Sciences 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:

• 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.
• Will receive a written critique.

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

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

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

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.

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.

After negotiation of a budget agreeable to the agencies and to each institution whose application is recommended for funding, NSF and NIEHS will come to agreement on the portion of the total research cost for each institution to be borne by each agency. Each grantee institution will then be required to submit a revised budget to NIEHS for the portion of the cost to be covered by an award from NIEHS according to the NIH Grants Management Policy Statement. The corresponding request to NSF shall be submitted as part of a regular research application that will detail the components of the research program that will be funded by NSF. The applications will conform to all provisions of the NSF Grant Proposal Guide.

NSF and NIEHS will separately issue awards to each grantee. Awards will be approved, monitored, and closed out in accordance with the award terms and conditions of the issuing agency.

NSF and NIEHS program officers will jointly administer scientific and technical aspects of the program. Budgetary and grants management of awards will be administered by each agency consistent with that agency's established policies and procedures.

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 grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

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

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. 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. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and http://www.hhs.gov/ocr/civilrights/understanding/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

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 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

Grantees will be required to prepare and submit to the granting agencies annual progress reports containing a description of accomplishments in the past year, a research plan and (in the case of NIEHS) a detailed budget for the coming year, according to each agency's procedures. Progress reports will be sent simultaneously to each agencies.

When multiple years are involved, awardees 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 progress report, 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.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.

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

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

eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, 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)

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726
Email: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-710-0267

Frederick L. Tyson, PhD
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-541-0176
Email: [email protected]

Henrietta (Hedy) N. Edmonds, PhD
National Science Foundation (NSF)
Telephone: 703-292-7247
Email: [email protected]

Linda K. Bass, PhD
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-541-1307
Email: [email protected]

Michelle Victalino
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-316-4666
Email: [email protected]

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

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