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; 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.

Required Application Instructions

It is critical that applicants follow the 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

The National Institute of Environmental Health Sciences (NIEHS) invites qualified investigators from domestic institutions of higher education to submit an application for a Superfund Research Program (SRP) Center grant. SRP legislation, under the Superfund Amendments and Reauthorization Act (SARA) of 1986, allows NIEHS the flexibility to create university-based Centers to conduct scientific research to address the wide array of scientific uncertainties facing the national Superfund program. The complex problems related to sites impacted by hazardous substances require the expertise of multiple biomedical and environmental science and engineering disciplines. Applicants responding to this Funding Opportunity Announcement (FOA) are expected to design a research Center that integrates environmental health science with environmental science and engineering (e.g., geochemical, ecological sciences). The goal of the NIEHS SRP Center is to improve public health by supporting integrative, multidisciplinary research incorporating the following:

Responsiveness to Mandates: SARA Section 311(a) Hazardous Substances Research and Training, authorizes NIEHS to create a basic research and training program for the development of:

1) advanced techniques for the detection, assessment, and evaluation of the effect of hazardous substances on human health;

2) methods to assess the risks to human health presented by hazardous substances;

3) methods and technologies to detect hazardous substances in the environment; and

4) basic biological, chemical, and physical methods to reduce the amount and toxicity of hazardous substances.

To accomplish these mandates, Centers are expected to assemble interdisciplinary research and training teams with expertise in biomedical science, environmental science and engineering, research translation, and community engagement.

Relevance to Superfund: SRP considers the diverse research and information needs of its stakeholders as important criteria for determining relevance. The SRP’s primary stakeholders are its sister Superfund programs at the U.S. Environmental Protection Agency (EPA, http://www.epa.gov/superfund/index.htm) and Agency for Toxic Substances and Disease Registry (ATSDR, http://www.atsdr.cdc.gov). Additional stakeholders include other Federal agencies, State, local, and Tribal communities impacted by hazardous substances. SRP’s ultimate goal is to protect human health by providing a rigorous scientific basis for effective decision-making by these stakeholders. Consequently, SRP-funded research is expected to provide fundamentally sound science, while providing data, information, and knowledge to inform the risk assessment and remediation management processes. Therefore, investigators should seek input from stakeholders during application development and identify critical issues for which fundamental science is needed.

Problem-based, Solution-oriented Research Theme: As an integrated research program, SRP Centers have the opportunity to tackle complex biomedical and environmental science and engineering issues identified by stakeholders, bringing a mechanistic understanding to solve some of the vexing problems associated with Superfund. Applicants are expected to design Centers that will contribute to solving a particular problem (or set of problems) related to SRP’s mandates: health effects, risk, detection, and/or remediation of hazardous substances. Moreover, Centers are expected to demonstrate the following:

• Innovation: SRP strives to push the boundaries of science using the newest technologies and challenging the current scientific paradigms. SRP firmly supports trans-disciplinary research, through the synthesis and extension of disciplinary boundaries that adapt technologies and approaches from one field and apply them to other fields in order to solve challenging environmental health problems. Forward-looking or anticipatory research is critical to identify and address future stakeholder needs. This may include utilizing cutting-edge research tools, developing new risk frameworks, or devising more sustainable solutions to address issues associated with hazardous substances.
• Integration: SRP considers integration of projects and cores as an important way to target problem(s) within the SRP's mandate areas. Centers should demonstrate evidence that interaction between projects and cores is necessary to resolve a problem that the Center proposes. Furthermore, integration and interaction should be demonstrated between the biomedical with the environmental science and engineering projects as they contribute to the Center goals. The research emanating from the Center and the interaction between the projects and cores should be incorporated into sustainable solutions that take into account environmental, social, and economic issues.

Research Translation: SRP is committed to fostering the translation of the scientific accomplishments emanating from an SRP Center to its stakeholders in order to support its mandates. A required Research Translation Core (RTC) will facilitate and coordinate communication of the results, accomplishments, and implications of the Center’s research to stakeholders, including NIEHS SRP staff and to other SRP Centers, in a context that makes the research applicable to the target audience. In addition, the RTC functions as a resource to assist in identifying and facilitating potential investigator-initiated research translation opportunities. The RTC serves as a conduit to assist in moving project outcomes to end-users and is not meant to be a pilot project/activity program.

Community Engagement: The SRP views Community Engagement as an effective way to inform and advance science for public health protection. All applicants are required to include a Community Engagement Core (CEC). The purpose of the CEC is to direct best practices in community engagement for prevention and/or intervention - thereby providing potential solutions to communities to reduce or mitigate the impact of hazardous substance exposure. For the purposes of this FOA and to be consistent with its mandates, SRP refers to prevention/intervention as basic biological, chemical, and physical methods to reduce the amount and toxicity of hazardous substances. The CEC activities should complement the research strengths and problem-solving goals of the Center.

Training: The SRP requires applicants to include a Training Core to support graduate and postdoctoral level cross-disciplinary training in fields related to environmental health and environmental science and engineering. The SRP regards the Training Core as a vital component to the mentorship, education, and training of the next generation of environmental health and science professionals.

Applicants are encouraged to refer to the SRP’s Strategic Plan (http://www.niehs.nih.gov/research/supported/dert/cris/programs/srp/about/register/index.cfm) which describes and defines the objectives and goals of the SRP in order to address its mandates. The three primary objectives of the SRP are to (1) address issues of high relevance, (2) maximize the impact of SRP investments, and (3) foster innovation. In addition, the SRP Mandates are provided on the following website: http://www.niehs.nih.gov/research/supported/dert/cris/programs/srp/about/program/index.cfm.

The scope of the SRP Center is defined by the SRP Mandates. Research and supporting activities under this FOA may utilize a variety of approaches to achieve SRP mandates, listed here:

1) Advanced techniques for the detection, assessment, and evaluation of the effect of hazardous substances on human health.

SRP seeks to support mechanistic and/or mode of action research that includes laboratory- and population-based studies for unraveling critical biological pathways that contribute to disease when perturbed by environmental contaminants. Highly innovative approaches such as high-throughput screening techniques, systems biology, -omics approaches, tissue engineering, and in silico modeling are desired. Also, discovery and validation of technologies useful for exposure assessment, indicators of biological response, and disease susceptibility are important research activities with translational opportunities for improved risk assessment. Priority will be placed on research with a clear connection to understanding health effects relevant to populations living near or affected by sites impacted by hazardous substances. In addition, applicants are encouraged to pursue toxicological endpoints for chemicals lacking toxicological data that are also found at Superfund (and related) sites.

2) Methods to assess the risks to human health presented by hazardous substances.

Within the interdisciplinary framework of its mandates, the SRP focuses on developing integrated human and ecologic risk models to assist in making cost-effective and protective decisions. As a component of risk, understanding the complex phenomena that impact hazardous substance exposure is an important research focus for the SRP. Exposure science research of interest includes: fate, transport, and transformation of contaminants in the environment; contaminant bioavailability in the environment and in biological systems; identifying biomarkers of exposure; and quantifying body burden. SRP also recognizes the need for developing methods to integrate exposure over time and to characterize the attributable risk from multiple exposures experienced over one’s lifetime. Cumulative risk models could be used to synthesize findings from health effects research, susceptible life stages, the influence of non-chemical and other modifiers of stressors, indirect effects, and mode of action to support more complex exposure assessments in susceptible and underserved populations (e.g., medically and economically disadvantaged). Studies that validate or confirm risk reduction due to prevention or intervention activities (e.g., remediation, nutritional intervention) are also within SRP scope. Although SRP recognizes the important public health impact of research focusing on exposures to consumer product-related chemicals, non point-source air pollution, and non point-source drinking water, a higher priority will be placed on research with a clear connection to understanding exposures relevant to populations living near or affected by sites impacted by hazardous substances.

3) Methods and technologies to detect hazardous substances in the environment.

The SRP seeks to support the development and application of new and advanced technologies for detection and monitoring of hazardous substances. Site characterization can be an expensive and invasive process. The SRP seeks development of novel methods and devices that offer precise and low-cost measuring capabilities of hazardous substances, with relevance to Superfund. This includes bioassays or ecological indicators that assess toxicity to biological systems at sites complicated by multiple contaminant streams or complex environmental media. In addition, innovative tools that allow for real-time, minimally invasive, on-site monitoring are encouraged, including: advanced sensors and probes, biosensors, new imaging modalities (e.g., geophysical imaging), self-contained miniaturized toxicity-screening kits, miniaturized analytical probes, and data analysis tools. The SRP also seeks in situ devices that are capable of multi-analyte readings and/or determination of the degree of bioavailability of a contaminant (e.g., passive sampling devices). Applicants are encouraged to develop sensor technologies applicable to complex media (e.g., soil, sediments, and groundwater). Tool designs should take into account device reuse, waste generation, and utilization of non-toxic components (particularly for in situ devices). Applicants are encouraged to propose technologies and methodologies that confer practical advantages over existing technologies (e.g., low-cost, user-friendly, readily accessible, and easily deployable for environmental disaster response).

4) Basic biological, chemical, and physical methods to reduce the amount and toxicity of hazardous substances.

The SRP supports the application of relevant research as a prevention strategy to improve human health by mitigating exposure and reducing toxicity of environmental contaminants. SRP seeks research that is focused on the scientific principles and underlying processes that drive different remediation technologies as methods to clean up persistent toxicants in various media such as groundwater, sediments, fractured bedrock, and soils. SRP encourages the continuum of research to focus on the translation of these basic principles into feasible, efficient, and cost-effective chemical, physical, and/or biological technologies that reduce and/or completely eliminate contamination present in the environment. Combined remediation approaches are encouraged as a means to maximize the complete degradation of hazardous substances. SRP also encourages development of greener and more sustainable remediation techniques that improve energy efficiency and reduce waste generation. The multidisciplinary framework of SRP facilitates collaboration between health effects, ecological and remediation scientists to assess and mitigate unintended toxicological implications of the remediation technology as well as assess the efficacy of remediation activities for reducing exposures risk and disease incidence.

Examples of Research Topics: As specified in the SRP Strategic Plan, the SRP seeks to improve relevance through encouraging applicants to design problem-based, solution-oriented research to address the needs of its primary stakeholders (e.g., Superfund-related agencies, as well as the individuals and communities impacted by hazardous substances). Hence, applicants are encouraged to engage stakeholders as they develop research projects in order to identify critical gaps in knowledge for which basic research is needed. Furthermore, applicants are encouraged to develop community engagement research projects to address any one of the above mandates. For a listing of research areas of interest to the SRP, its sister Superfund agencies (i.e., EPA and ATSDR), and its stakeholders, please refer to the Suggested Research and Activities document on the following website (http://www.niehs.nih.gov/research/supported/srp/funding/rfa.cfm).

Applicants are encouraged to propose research that fills gaps or needs not currently addressed within the SRP. A list of current grantees can be found at the following website: http://tools.niehs.nih.gov/srp/programs/index.cfm.

Hazardous Substances: The SRP is not a site-specific program; however, in the most broad sense, hazardous substances found at Superfund sites are relevant to SRP. These substances include:

• Hazardous substances found at Superfund sites. (Applicants may refer to the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) Priority List website for information on hazardous substances associated with Superfund sites: http://www.atsdr.cdc.gov/SPL/index.html).
• Hazardous breakdown products of the above substances formed in environmental media by physical, chemical or biological (e.g., plants, microorganisms) processes.
• Hazardous metabolites of the above substances or their breakdown products formed after exposure in humans or in experimental animal models.

The applicant should refer to the Materials for Applicants link on the following website (http://www.niehs.nih.gov/research/supported/srp/funding/rfa.cfm) for a list of hazardous substances, including emerging contaminants, that have been suggested for study by SRP's sister agencies (i.e., EPA and ATSDR).

Applicants are encouraged to consult with SRP Scientific/Research staff for specific questions about the relevancy of a hazardous substance for this FOA as the presence of a compound on one of the lists mentioned above does not automatically make it relevant to the SRP. Per SARA Mandates, hazardous substances do not include petroleum, natural gas, natural gas liquids, liquefied natural gas, or synthetic gas usable for fuel.

NOTE: SRP is not a site-specific program. Applicants are not required to work on Superfund or hazardous waste sites.

Whether through project research or core activity, Centers are strongly encouraged to seek opportunities for interactions at Superfund and other managed hazardous waste sites. Superfund sites serve as a good conceptual model for research focusing on hazardous substances.

If on-site activities will be conducted, researchers must coordinate with appropriate Federal or State site officials and must observe best safety practices. When applicable, applicants must:

• propose a procedure for coordinating and documenting site activities including record of the research conducted, sample collected, or translation/engagement activities; and
• delineate procedures for bi-directional communication and outcome reporting to appropriate site officials, site managers, and SRP staff at NIEHS.

In addition, engagement of site officials in the early stages of project development and throughout the process is recommended, as this greatly increases the positive impact of SRP research and its utility to stakeholders. Links to stakeholder points of contact and suggestions for Hazardous Waste Site access are included on the Materials for Applicants webpage accessible from the following website: (http://www.niehs.nih.gov/research/supported/srp/funding/rfa.cfm).

It is the intent of the NIEHS to hold annual grantee meetings. The location of the meeting site will rotate among the different grantees and Research Triangle Park, NC. See Section IV. Application and Submission Information .

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)

Per NIEHS legislative authority, ONLY Higher Education Institutions may apply for award of this P42 FOA. Section 311(a)(3) of SARA limits recipients of awards to "accredited institutions of higher education," which are defined in the Higher Education Act, 20 USC (annotated) 3381. However, grantees are permitted under the law, and encouraged by NIEHS, to subcontract as appropriate with organizations, domestic or foreign, public or private (such as universities, colleges, hospitals, laboratories, faith-based organizations, units of State and local governments, and eligible agencies of the Federal Government) as necessary to conduct portions of the research. Examples of other organizations may include generators of hazardous wastes; persons involved in the detection, assessment, evaluation, and treatment of hazardous substances; owners and operators of facilities at which hazardous substances are located; State and local governments and community.

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

Applicant Organizations

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

• 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.

For the purposes of this FOA, the Program Director/Principal Investigator (PD/PI) will be referred to as the "Center Director." All project and core leaders will be referred to as "Project Leader" or "Core Leader."

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

Only one application per institution (normally identified by having a unique DUNS number or NIH IPF number) is allowed.

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).

Applicants can access the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants.gov.

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 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 Bass, PhD
Telephone: 919-541-1307
Fax: 301-480-3722
Email: [email protected]

Component Types Available in ASSIST	Research Strategy/Program Plan Page Limits
Overall	12
Core (use for Administrative Core, Research Translation Core, Community Engagement Core, and Research Support Core)	12 each Core
NRSA Training (use for Training Core)	25*
Project (use for Biomedical Research Projects and Environmental Science and Engineering Research Projects)	12 each Project

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

* The 'NRSA Training' component type will follow the page limits for the Institutional Training activity code as defined in the Table of Page Limits. Note that the limit of 25 pages refers to the combination of Background, Program Plan, and Recruitment and Retention Plan to Enhance Diversity (attachments 2-4 of Research Training Program Plan form).

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
• BiomedicalResearch Projects: required, minimum of 2
• Environmental Science and Engineering Research Projects: required, minimum of 2
• Administrative Core: required
• Research Translation Core: required
• Community Engagement Core: required
• Training Core: required
• Research Support Core: optional

Note: Applications must successfully meet these minimum requirements (4 required projects, 4 required cores (Administrative Core, Research Translation Core, Community Engagement Core, and Training Core)) without exceeding a total of 11 projects and cores.

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..

Project Summary/Abstract: For the Overall Component, applicants must include a Project Summary/Abstract that briefly describes the problem(s) being addressed by the Overall Center, how the Center solves target problem(s) related to health effects, risk, detection and/or remediation of hazardous substances. As opposed to a generic description of the Center components, the Project Summary should provide an overall indication of the proposed science and what the Center proposes to accomplish. For example, the summary should describe the hazardous substances, study sites, research approaches, model organisms/biological systems, disease pathways, etc. In addition, the Center should highlight aspects of the application that are particularly innovative or paradigm-shifting. The primary activities of the cores should be integrated into the summary. The benefits of the Center (in terms of improving public health, risk assessment, and risk management) should also be included. Ideally, the project summary provides a depth of understanding of the science and activities of the Center written in plain language for a diverse set of reviewers.

Project Narrative: It should be clear in the "Project Narrative" (i.e. the "public health relevance" statement) the relevance of the core activities to public health and to SRP stakeholders. SRP’s primary stakeholders are its sister Superfund programs at the U.S. Environmental Protection Agency (EPA) and Agency for Toxic Substances and Disease Registry (ATSDR). Additional stakeholders include other Federal agencies, State, local, and Tribal entities impacted by hazardous substances.

Other Attachments: The following "Other Attachments" should be included with the overall component in order to aid in the review of applications. The filename provided for each attachment will be the name used for the bookmark in the application image.

• Center Organizational Structure. Applicants should include a diagram of the organizational structure of the Center. This diagram should demonstrate how the interactions between the different Center components achieve integration and the mandate-driven goals of the Center. The diagram should be loaded as a pdf file titled "Center Organizational Structure". In this diagram, applicants should clearly indicate which projects are biomedical and which are environmental science and engineering research.
• Table of Research Support Core Utilization. In order to assist the reviewers in determining the relationship between the Research Support Cores and the research projects, a table should be provided that indicates the percentage use of each core relative to the individual projects. This table should be loaded as a pdf file titled "Table of Research Support Core Utilization".
• Table of Changes to Projects and Cores. To assist review of renewal/resubmission applications, include a table listing projects and core components (by project title and project/core leader) that denotes which projects are new, continuing, substantially modified, finished/completed, or discontinued. This table should coincide in order and number with the projects and cores in the current application. Also indicate which projects are considered to be biomedical research and which are considered environmental science and engineering research. ASSIST assigns projects/cores consecutively; therefore when numbering projects and cores, numbering should not be skipped if a project from a previous funding period is discontinued in the renewal application. Please label in the following format: new = N; continuing = C; substantially modified = M; finished/completed = F; or discontinued = D. This table should be loaded as a pdf file titled "Table of Changes to Projects and Cores".
• Table of Research Approaches. In order to facilitate the identification of projects and cores, a table should be included indicating the use of human subjects, vertebrate animals, international collaborations, and stem cells. Please list all research projects and cores. This table should be loaded as a pdf file titled "Table of Research Approaches".

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.

Introduction to Application: For Resubmission applications, an Introduction to Application is required in the Overall component.

Specific Aims: Applicants will provide Specific Aims for the Overall Center describing the objectives and goals of the Center, as they relate to the SRP Mandates. It should be clear how the components of the Center interact to solve the target problem(s), and the role of each project and core in contributing to resolving the problem(s) stated in the application. This section should provide greater scientific detail and approaches than the Project Summary/Abstract. In addition, each specific aim should be supported by a brief description of how that aim will be accomplished through interactions of projects and cores.

Research Strategy: Applicants must include an overview of the Center. In this section, applicants should clearly describe the problem(s) being addressed by the Overall Center, how the components of the Center interact to solve the target problem(s), and the role of each project and core in contributing to resolving the problem(s) related to health effects, risk, detection and/or remediation of hazardous substances. The problem being solved could be a discreet but critical gap in the larger context of a complex issue, or it may answer a discrete question that, if left unanswered, would create an impediment to effectively protecting public health. This section should also include background information and a description of how the Center’s research fits into the SRP mandates; and how the Overall Center is relevant to SRP’s primary stakeholders (e.g., U.S. EPA, Agency for Toxic Substances and Disease Registry (ATSDR), other Federal agencies, State, local, and Tribal communities impacted by hazardous substances). Applicants should provide a clear description of how the hazardous substance(s) being studied and subsequent results are relevant to Superfund; lead to better decision making for risk assessors and remediation managers at Superfund sites; and/or address uncertainties involved in understanding the prevalence of disease/dysfunction and/or the effects on molecular, cellular, and pathophysiologic parameters that lead to disease/dysfunction associated with these hazardous substances. A description of the innovative aspects of the Center should be included. This section should also include a description of the multidisciplinary and interdisciplinary nature of the Center, the interactions between the projects and cores, how each project and core contributes to the Center’s theme, and how the Center will achieve the integration and interaction among biomedical and environmental science and engineering research. Applicants should include a brief description of plans for the Administrative Core to facilitate the overall goals of the Center and maintain organization of the Center. (More detailed information on the management of these items should be included in the Administrative Core Research Strategy section.) The applicant should delineate a timeline for the synthesis of key data and findings from the projects and cores as it pertains to approaching a resolution to the stated problem(s). The following subsections are recommended: Overall Goals and Objectives; Background Information; Relevance to SRP Primary Stakeholders; Significance of the Research; Innovation; Integration of Multiple Disciplines; Center Management; Organizational Structure; and Timeline.

For Renewal Applications. Renewal applications must include, in the Research Strategy, a general progress report that describes achievements under the grant since the last competitive review. The Center Director (i.e., Program Director/Principal Investigator) should carefully prepare this section, and it should not be a copy of the material included for the individual projects. (The individual research projects will also provide a Progress Report under the Approach section of the Research Strategy.) This is the section where the benefits of the Center can be expressed/demonstrated. Items to be included are:

• Brief summary of major accomplishments that can be attributed to the SRP Center Grant.
• Brief explanation of how the accomplishments of the Center have contributed to the National Superfund Program (i.e. National Priorities List sites and/or related sites contaminated by hazardous substances).
• Brief report on projects and cores that are not being continued, and the reason for deleting them from the Center. Be certain to reference relevant tables (e.g. "Table of Changes to Projects and Cores," described above).

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:

Note: A Resource Sharing Plan should be included, as appropriate, for the overall Center for data-sharing activities that involve multiple projects and/or cores. This plan for sharing data should describe coordinating efforts of the overall Center regarding sharing of data within and/or beyond the SRP Center. Information included in the overall Center should complement but not duplicate project/core Resource Sharing Plans.

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.

The SRP requires a minimum of two Biomedical and two Environmental Science and Engineering Research Projects (maximum of 6 projects). Collectively, the Center's research projects should emphasize a balance of basic and applied research that contributes to the problem-based, solution-oriented goal of the Center. The Center’s central problem should be addressed by the contributions of these projects and should, therefore, include the biomedical and environmental science and engineering expertise necessary to address the central problem. Each project should contribute to the overall Center objective, providing a clear step towards identifying solutions to these problems. Projects should be hypothesis-driven or product-oriented research.

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.

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 Summary/Abstract: Include a Project Summary/Abstract that briefly describes how the project will solve target problem(s) related to health effects, risk, detection and/or remediation of hazardous substances. For example, the summary should describe the hazardous substances, study sites, research approaches, model organisms/biological systems, disease pathways, etc. In addition, the project should highlight aspects of the application that are particularly innovative or paradigm-shifting. Ideally, the project summary provides a depth of understanding of the science and activities of the project written in plain language for a diverse set of reviewers.

Project Narrative: It should be clear in the "Project Narrative" (i.e. the "public health relevance" statement) the relevance of the core activities to public health and to SRP stakeholders. SRP’s primary stakeholders are its sister Superfund programs at the U.S. Environmental Protection Agency (EPA) and Agency for Toxic Substances and Disease Registry (ATSDR). Additional stakeholders include other Federal agencies, State, local, and Tribal entities impacted by hazardous substances.

List all performance sites that apply to the specific component (e.g., all collaborating organizations and study sites).

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 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 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.

Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for each component.

Specific Aims: Specific Aims should describe the objectives and goals of the project as it relates to the SRP Mandates. The specific aims section should also contain a brief statement about how the project integrates with the rest of the Center.

Research Strategy: The Biomedical Research Projects should address biomedical or human health-related implications of hazardous substances. This includes but is not limited to: mechanistic-based toxicology studies, epidemiology, human risk assessment, genetic susceptibility, computational toxicology, or biomedical engineering.

The Environmental Science and Engineering Research Projects should address environmental science or engineering implications of hazardous substances. These projects are integral to the protection of human health through predicting, detecting, and preventing exposures. Environmental science and engineering research projects include, but would not be limited to: civil/environmental engineering, geology, ecology, microbiology, fate and transport studies, hydrogeology, remediation, and detection sciences.

Relevance to Superfund: Applicants should clearly describe how results gained from the studies are relevant to Superfund. They should also indicate how these studies will lead to better decision making for risk assessors and remediation managers at Superfund sites and/or address uncertainties involved in understanding the prevalence of disease/dysfunction and/or the effects on molecular, cellular, and pathophysiologic parameters that lead to disease/dysfunction associated with these hazardous substances. Applicants should provide a clear explanation of how the hazardous substance(s) being studied are relevant to Superfund, particularly for emerging contaminants or hazardous substances not typically associated with Superfund sites. However, it is noted that the SRP is not a site-specific program. Therefore, projects are not required to work on a Superfund or other hazardous waste site; however, researchers are encouraged to look for opportunities to do so. Suggestions for how establish site-related contacts can be found in the Hazardous Waste Site access document on the Materials for Applicants webpage accessible from the following website: (http://www.niehs.nih.gov/research/supported/srp/funding/rfa.cfm).

Problem-based, Solution-oriented Research: Applicants should clearly describe the problem(s) being addressed by the project. The problem being solved could be a discreet but critical gap in the larger context of a complex issue, or it may answer a discrete question that, if left unanswered, would create an impediment to effectively protecting public health.

In addition to addressing Significance, Innovation, and Approach, the Research Strategy should describe the Project's "Relation to Overall Center", as well as Community Engagement Best Practices (as appropriate).

Relation to Overall Center: In this statement, clearly state the relevance of the project to the goals of the overall Center, how this project integrates with other projects and cores, and how the findings/activities of this project assist in solving the problem(s) that the Center is addressing. Interactions with the Research Translation Core should also be included.

Community Engagement Best Practices: For community engagement research projects and projects that involve significant interactions with communities, a "Community Engagement Best Practices" statement should be included. This may include the following: description of the defined community of interest or community partner and the community's and researchers' roles; how the research activity will lead to improved public understanding of research and long-term, bidirectional relationships between the academic institution and the community for the benefit of both; the community's acceptance of the role as a partner in the project and that the community's engagement is an integral part of the research activity (e.g., letters of support from the community can be attached via Letters of Support); how the participating community (or community group) will be involved in the design and approach of the research from the onset through to the conclusion of the activity; a management plan for maintaining transparent communications between the community and the academic partners throughout the entirety of the activity (the plan should address methods of building and sustaining community partnerships and community participation). Include community engagement activities with the project timeline to provide a tentative sequence for the community engagement aspects of the research.

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. Projects are expected to include within their Data Sharing Plan an Investigator-Initiated Research Translation Plan. The Investigator-Initiated Research Translation Plan (IIRT) should describe a plan for research translation for each project. This plan should be cross-referenced in the Research Translation Core Research Strategy. Examples of IIRT activities are provided for reference in the Suggested Research and Activities document on the following website (http://www.niehs.nih.gov/research/supported/srp/funding/rfa.cfm).

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.

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

When conducting clinical research, follow all instructions for completing Cumulative 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 (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.

Summary/Abstract: Include a Core Summary/Abstract that briefly describes how the Administrative Core will lead the Center and ensure that the projects and cores are being supported to achieve the Center’s goals. The summary should not be a general description of the requirements of the Administrative Core. Rather, applicants should highlight specific activities and innovative plans for meeting the core requirements, tailored to fit the overall goals of the Center.

Project Narrative: It should be clear in the "Project Narrative" (i.e. the "public health relevance" statement) the relevance of the core activities to public health and to SRP stakeholders. SRP’s primary stakeholders are its sister Superfund programs at the U.S. Environmental Protection Agency (EPA) and Agency for Toxic Substances and Disease Registry (ATSDR). Additional stakeholders include other Federal agencies, State, local, and Tribal entities impacted by hazardous substances.

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

List all performance sites that apply to the specific component (e.g., all collaborating organizations and study sites).

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)

The application must name the Center Director who will serve as the Program Director/Principal Investigator (PD/PI) of the Center and Core Leader of the Administrative Core.

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

Note: A Deputy Director may also be named within the Administrative Core. Center Director's should consider choosing a Deputy Director with expertise that complements and broadens the overall theme of the Center. For example, if the Center Director has expertise in biomedical research, the Deputy Director would have expertise in environmental science and engineering.

Budget (Administrative Core)

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

Funds for travel by appropriate staff (i.e., Center Director, Center Administrator, Training Core leader, Research Translation Core leader, Community Engagement Core leader, and four trainees) to attend the Superfund Research Program three-day annual meeting shall be included in the Administrative Core’s budget for each year.

The Center Director must commit a minimum of 1.8 person months to the administration of the Center. The Administrative Core annual budget must not exceed $100,000 Direct Costs for both new and renewal applications. Note: The sum of Direct Costs for the Administrative, Research Translation, Community Engagement, and Training Cores cannot exceed 20% of the total Direct Costs of the Center per year.

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 (Administrative Core)

Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for each component.

Specific Aims: Specific Aims should describe the objectives and goals of the Core. The specific aims section should also contain a brief statement about how the Core will lead the Center and how it will integrate the Center.

Research Strategy: The application should describe how the Administrative Core and Center Director will provide leadership and guidance in ensuring the synthesis of findings and activities from research projects and cores towards solving the central problem/objective proposed by the Center. To accomplish this, the applicant must create within the Administrative Core an infrastructure that promotes cross-discipline interactions among all of the projects and cores and ensures research translation.

The Administrative Core's Research Strategy should demonstrate how the core will achieve its administrative functions, as described below. The applicant should include a description of the lines of communication among the Center project and core leaders, and a description of the mechanisms to be used to encourage and ensure the integration and interaction between the biomedical and environmental science and engineering projects within the Center. The plan should also describe their strategy for planning and coordinating research and core activities; coordinating research activities and research translation activities; the integration of cross-disciplinary research; overseeing of fiscal and resource management; and providing quality management. This section should indicate who will be responsible for each of these activities and should describe the role(s) of advisory groups and consultants.

To aid the Center Director in achieving the goals set forth for his or her Center, the Administrative Core is required to establish an External Advisory Committee (EAC) to provide guidance to the Center Director in the following areas:

• the scientific merit of the research and productivity
• the relevance and importance of the individual components to the goals of the Center
• the integration of research across disciplines
• the effectiveness of research translation activities in linking projects to stakeholders
• the appropriateness of community engagement and training activities
• discussion of projects that should be continued, modified, or discontinued and strategy for making changes to projects
• succession plan for the Center Director or project/core leaders if they leave the Center

The composition of the committee will reflect the goals of the Center and will include appropriate scientific expertise and appropriate stakeholders, which will include, for example, representatives from the EPA, ATSDR, industry, and/or community organizations, as examples. All applicants should list the anticipated/target areas of expertise for EAC members. New applicants should not list names of anticipated EAC members, unless they provide input into the design of the application.

The Research Strategy for the Administrative Core should include a "Relation to Overall Center" statement. In this statement, clearly state the relevance of the Core to the goals of the overall Center, how this Core will integrate with other projects and cores, and how the findings/activities of this Core will assist in solving the problem(s) that the Center is addressing. Interactions with the Research Translation Core should also be included. The Administrative Core will be responsible for ensuring that updates are made to the SRP Data Collection Form (http://tools.niehs.nih.gov/srp/resources/rtc.cfm) and to the NIH CareerTrac database (https://careertrac.niehs.nih.gov/) and should designate points of contact responsible for reporting this information, as well as a plan for frequency of reporting.

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.

Planned Enrollment Report (Administrative Core)

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

PHS 398 Cumulative Inclusion Enrollment Report (Administrative Core)

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

The SRP requires a Research Translation Core (RTC) in each SRP Center grant application. For the purpose of this FOA, the SRP defines Research Translation as communicating and facilitating the use of research findings emanating from the Center in the manner most appropriate for their application and the advancement of research objectives. The SRP Strategic Plan highlights the importance of investigator-initiated research translation. Hence, each RTC has a critical role in assisting project/core leaders in translating research outcomes to appropriate audiences, thereby encouraging the accurate and timely use of these research products.

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 (Research Translation 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 (Research Translation Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Research Translation 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.

Summary/Abstract: Include a Core Summary/Abstract that briefly describes how the Research Translation Core will support the Center. The summary should not be a general description of the requirements of the Research Translation Core. Rather, applicants should highlight specific activities and innovative plans for meeting the core requirements, tailored to fit the overall goals of the Center.

Project Narrative: It should be clear in the "Project Narrative" (i.e. the "public health relevance" statement) the relevance of the core activities to public health and to SRP stakeholders. SRP’s primary stakeholders are its sister Superfund programs at the U.S. Environmental Protection Agency (EPA) and Agency for Toxic Substances and Disease Registry (ATSDR). Additional stakeholders include other Federal agencies, State, local, and Tribal entities impacted by hazardous substances.

Project /Performance Site Location(s) (Research Translation Core)

List all performance sites that apply to the specific component (e.g., all collaborating organizations and activity sites).

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 Translation Core)

The RTC leader/staff should have the appropriate scientific and policy background to effectively work within their Center to translate research and effectively work with science and public health experts.

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

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

The Research Translation Core annual budget must not to exceed $100,000 Direct Costs. Note: the sum of Direct Costs for the Administrative, Research Translation, Community Engagement, and Training Cores cannot exceed 20% of the total Direct Costs of the Center per year.

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 Translation Core)

Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for each component.

Specific Aims: Specific Aims should describe the plan for research translation which includes: 1) Communicating within SRP; 2) Partnerships with Government Agencies; 3) Technology Transfer; 4) Information Dissemination to Other End-users. The specific aims section should also contain a brief statement about how the Core integrates with the rest of the Center.

Research Strategy: Within the Research Strategy, the application should describe how the RTC will achieve the following objectives in support of achieving effective research translation: 1) Communicating within SRP; 2) Partnerships with Government Agencies; 3) Technology Transfer; 4) Information Dissemination to Other End-users. The Research Strategy section should provide a plan to achieve all four objectives. These objectives are described below:

1) Communicating within SRP: NIEHS requires the RTC to communicate both within its institutional Center, as well as the greater SRP network (i.e. other SRP Centers, grantees, and SRP staff at NIEHS). Therefore, there is an expectation for the RTC to serve several key communication roles such as:

a) Investigator-initiated research translation (IIRT): RTC will work with each project investigator to identify and coordinate research translation opportunities for each Center project and cores, as appropriate (see Project "Resource Sharing Plan" above). Examples of IIRT activities are provided in the Suggested Research and Activities document on the following website (http://www.niehs.nih.gov/research/supported/srp/funding/rfa.cfm).

b) SRP communication: reporting research translation and other activities to SRP staff at NIEHS

c) Cross-Center communication: communicating with RTCs from other SRP Centers

Applicants are expected to delineate a plan and timeline for coordinating activities at all four levels listed above. Of note, a direct line of communication between the Administrative Core and the RTC is extremely important, given the role of the Administrative Core to ensure an effective research translation strategy for the Center. Points of contact should be indicated in the Research Strategy section, particularly with regard to monthly SRP RTC/CE conference calls and submitting Center materials to the SRP Data Collection Form. (The SRP Data Collection Form allows grantees to inform SRP staff of Center Activities such as webinars/meetings, interactions with stakeholders, trainee/investigator awards, news articles and publications: http://tools.niehs.nih.gov/srp/resources/rtc.cfm.)

2) Partnerships with Government Agencies: Establishing ongoing communication with the Federal, State, local, and/or Tribal agencies charged with protecting human health and the environment is of high importance. These partnerships ensure that governmental offices have first-hand access to the valuable resources the Center’s projects can provide, and that the investigators have feedback on the real and immediate needs faced by their counterparts in the public sector. EPA and ATSDR are directly involved in Superfund efforts (e.g., remediation, risk assessments, exposure studies); therefore, partnerships with these agencies are a high priority to SRP. It is important that in the RTC Research Strategy, each applicant has a plan delineating bi-directional interactions with the appropriate government agencies, identifying shared interests and outlining how to address these needs/interests.

3) Technology Transfer: It is important that each Center identifies opportunities and delineates mechanisms for the transfer of biomedical and environmental science and engineering technologies generated by the Center’s projects into the hands of an end-user. RTCs may accomplish technology transfer through coordinating with formal technology transfer mechanisms (patents, Small Business Innovation Research/Small Business Technology Transfer Research grants, coordinating with institutional technology transfer offices), as well as informally through moving research from bench scale to demonstration, creating web-accessible data sharing systems to host information that may improve upon current risk assessments, or moving biomarker research towards epidemiological, clinical, or population based applications. As part of technology transfer, grantees are encouraged to provide informal technology support, to document the use of the research product, and to assess its value to public health or environmental management.

4) Information Dissemination to Other End-users: Another important RTC activity is to transfer the knowledge gained from Center’s projects activities (scientific discoveries, research findings) beyond the government or marketplace, allowing Center outcomes to make a broader impact. The intent is to bring together and provide a forum for investigators and stakeholders to enhance collaboration and utilization of SRP research. SRP therefore requires a plan to disseminate information from the Center to other important end-users such as formal/informal educational groups, hazardous waste practitioners, the lay public, and other academic researchers.

A variety of appropriate RTC activities and resources, including stakeholder contact information, have been listed in the Suggested Research and Activities document on the following website (http://www.niehs.nih.gov/research/supported/srp/funding/rfa.cfm). For all such activities, best communication practices must be utilized. As a reference, please see the NIH website on plain language: http://grants.nih.gov/grants/plain_language.htm. Use of web-broadcasting of these communication activities is particularly encouraged to accommodate stakeholders in remote locations or with limited travel options. Applicants should describe how Research Translation Core activities are relevant to Superfund.

The Research Strategy section of the Research Translation Core should include a "Relation to Overall Center" statement. In this statement, clearly state the relevance of the Core to the goals of the overall Center, how this Core will integrate with other projects and cores, and how the findings/activities of this Core will assist in solving the problem(s) that the Center is addressing.

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.

Planned Enrollment Report (Research Translation Core)

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

PHS 398 Cumulative Inclusion Enrollment Report (Research Translation Core)

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

SRP considers the individuals and communities affected by hazardous substances as key stakeholders and recognizes the opportunity for SRP Center research and activities to achieve positive public health benefits through bidirectional interactions between the Center and impacted communities. The purpose of the SRP Community Engagement Core (CEC) is to direct best practices in community engagement for hazardous substance exposure prevention and intervention. For the purposes of this FOA, SRP refers to prevention and intervention as basic biological, chemical, and physical methods to reduce the amount and toxicity of hazardous substances. Through exposure prevention and intervention, the CEC empowers impacted communities to be full participants in decisions to reduce the amount and toxicity of hazardous substances whether in their homes, their schools, their community, and/or their environment.

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.

Summary/Abstract: Include a Core Summary/Abstract that briefly describes how the Community Engagement Core will support the Center. The summary should not be a general description of the requirements of the Community Engagement Core. Rather, applicants should highlight specific activities and innovative plans for engaging the community in appropriate prevention and intervention activities, tailored to fit the overall goals of the Center and complements the Center s research. The prevention/intervention activity should relate to basic biological, chemical, and physical methods to reduce the amount and toxicity of hazardous substances. The summary should give a clear indication about which community or communities are planned for partnerships, as well as which hazardous substances are impacting the community or communities.

Project Narrative: It should be clear in the "Project Narrative" (i.e. the "public health relevance" statement) the relevance of the core activities to public health and to SRP stakeholders. SRP’s primary stakeholders are its sister Superfund programs at the U.S. Environmental Protection Agency (EPA) and Agency for Toxic Substances and Disease Registry (ATSDR). Additional stakeholders include other Federal agencies, State, local, and Tribal entities impacted by hazardous substances.

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

List all performance sites that apply to the specific component (e.g., all collaborating organizations and activity sites).

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 Core Leader' 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.

The Community Engagement Core annual budget must not to exceed $100,000 Direct Costs. Note: the sum of Direct Costs for the Administrative, Research Translation, Community Engagement, and Training Cores cannot exceed 20% of the total Direct Costs of the Center per year.

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.

PHS398 Research Plan (Community Engagement Core

Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for each component.

Specific Aims: Specific Aims should describe the objectives and goals of the Core. The specific aims section should also contain a brief statement about how the Core integrates with the rest of the Center.

Research Strategy: The SRP defines target communities as those impacted by hazardous substances; therefore, CEC activities should involve intervention and prevention activities with members of the affected community. CEC may work in partnership with the community and/or community-serving organizations such as: local government groups, Tribal councils, community service groups focused on educating the community about local issues, or non-governmental organizations working closely with a community. There is particular interest in engagement of economically disadvantaged, environmental justice (EJ), and Tribal communities which are severely impacted by hazardous substances. It is important to note that communities are often comprised of several distinct subpopulations. Community representation should reflect the various segments within an affected community and translation of research findings should be targeted to the specific needs of these distinct groups. This might include identifying informational needs based on age, ethnicity, race, gender, or residency status (permanent vs. transient).

The CEC is to be designed to fit within the theme of the Center. Appropriate objectives of the CEC include capacity building, developing tools/resources, facilitating bi-directional exchange between Center scientists and the community with the overall intent to prevent and/or intervene in order to reduce exposure and protect health. A variety of appropriate CEC activities and resources have been listed in the Suggested Research and Activities document on the following website (http://www.niehs.nih.gov/research/supported/srp/funding/rfa.cfm). Applicants should describe how CEC activities are relevant to Superfund.

In the Research Strategy, the CEC should include a timeline with milestones; a plan to measure and verify outcomes (e.g., a logic model); and a process to guarantee effective bi-directional exchange of needs, recommendations, and results. Expectations between the community and academic partners should be made transparent, including deliverables, time commitment, as well as plans for future interactions beyond the life of the grant. Also within the Research Strategy, the CEC should include the following:

• A clearly defined community of interest or community partner and the community's and researchers' roles.
• Prevention/intervention opportunities that are of interest/priority to the community.
• How the prevention/intervention activity will lead to improved public understanding of research and long-term, bidirectional relationships between the academic institution and the community for the benefit of both.
• The community's acceptance of the role as a partner in the core and that the community's engagement is an integral part of the core prevention/intervention activity (e.g., letters of support from the community can be attached via Letters of Support).
• How the participating community (or community group) will be involved in the design and approach of the activity from the onset through to the conclusion of the activity.
• A management plan for maintaining transparent communications between the community and the academic partners throughout the entirety of the activity. The plan should address methods of building and sustaining community partnerships and community participation.

The Research Strategy section of the Community Engagement Core should include a "Relation to Overall Center" statement. In this statement, clearly state the relevance of the Core to the research goals of the overall Center, how this Core will integrate with other projects and cores, and how the findings/activities of this Core will assist in solving the problem(s) that the Center is addressing. Interactions with the Research Translation Core should also be included.

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.

Planned Enrollment Report (Community Engagement Core)

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

PHS 398 Cumulative Inclusion Enrollment Report (Community Engagement Core)

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

The SRP requires applicants to include a Training Core to support cross-disciplinary training in fields related to biomedical and environmental science and engineering. SRP mandates specify graduate level training (e.g., Masters, PhD. Post doc); therefore, SRP defines "trainees" within the core as graduate students and post-doctoral researchers as either supported directly by the Center or performing research/activities that are supported by the Center. While undergraduates are recognized as a part of the research continuum and are allowed to participate in Training Core activities, the Training Core should direct its opportunities for integration and professional development among the graduate and post-doctoral level trainees within the Center.

When preparing your application in ASSIST, use Component Type NRSA Training.

Follow all instructions provided in the SF424 (R&R) Application Guide for Preparing Institutional Ruth L. Kirschstein National Research Service Award (NRSA) except where indicated below.

SF424 (R&R) Cover (Training Core)Complete only the following fields:

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

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

Follow "Special Instructions for 4.3 Research & Related Project/Performance Site Locations" provided in the SF424 (R&R) Supplemental Instructions for Preparing Institutional Ruth L. Kirschstein National Research Service Award (NRSA) Application.

Research & Related Other Project Information (Training Core)

Follow "Special Instructions for 4.4 Research & Related Other Project Information Form" provided in the SF424 (R&R) Supplemental Instructions for Preparing Institutional Ruth L. Kirschstein National Research Service Award (NRSA) Application, with the following additional modifications:

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 Summary/Abstract: Summarize the objectives of the Training Core. Provide information regarding the research areas and scientific disciplines encompassed by the Center. Include a brief description of the level(s) (i.e., graduate student, postdoctoral) and duration of the proposed training, the projected number of participating trainees and their anticipated levels of experience.

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.

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

Follow "Special Instructions for 4.5 Senior/Key Person Profile (Expanded) Form" provided in the SF424 (R&R) Supplemental Instructions for Preparing Institutional Ruth L. Kirschstein National Research Service Award (NRSA) Application, with the following additional modifications:

The Training Core Leader and any other individuals whose contributions are critical to the development, management and execution of the Training Core in a substantive, measurable way (whether or not salaries are reimbursed) should be identified as senior/key persons. These would include co-Leader(s), if applicable, and other Training Core staff. Do not include proposed mentors and training faculty members (other than senior/key persons) in this section. Biographical Sketches for mentors and participating faculty will be included in the PHS 398 Research Training Program Plan Form, Participating Faculty Biosketches attachment.

For budget purposes, trainees should be listed in the appropriate project/core budget pages, and should not be listed as key personnel.

• 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 core.
• 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.

PHS 398 Cover Page Supplement (Training Core)

Follow "Special Instructions for 4.6 PHS 398 Cover Page Supplement" provided in the SF424 (R&R) Supplemental Instructions for Preparing Institutional Ruth L. Kirschstein National Research Service Award (NRSA) Application.

PHS 398 Training Budget Component (Training Core)

For the Training Core, follow "8.5. PHS 398 Training Budget" provided in the SF424 (R&R) Supplemental Instructions for Preparing Institutional Ruth L. Kirschstein National Research Service Award (NRSA) Application, with the following additional modifications:

The Training Core annual budget must not exceed $100,000 Direct Costs. Note: the sum of Direct Costs for the Administrative, Research Translation, Community Engagement, and Training Cores cannot exceed 20% of the total Direct Costs of the Center per year).

Part A: The application may request stipends for the trainee. Stipend amount should be consistent with NIH policy and is expected to be consistent with trainee salaries listed in Projects and Cores. In addition, "Tuition/Fees" in the training core should be consistent with trainee Tuition/Fees from Project and Core budgets. Note: while NRSA stipend levels do not apply to this FOA, applications may use the current NRSA stipend levels as a guide to determining appropriate compensation for the trainees.

The training of graduate students and post-doctoral researchers may be conducted outside the structured Training Core, and may occur within a project or another core. In these instances, salary and other related training costs (e.g., equipment, supplies) should be part of the project or core budgets rather than the Training Core budget. However, it is recommended to indicate (in the Training Core budget justification) the number of trainees participating in the Training Core whose salary/costs are being covered in their respective research projects/cores.

Part B: Enter the total costs for Trainee Travel. Each trainee may travel to one scientific meeting per year. Include expenses associated with the training core (such as salary support for Training Core Leader and other staff, consultant costs, equipment, research supplies, staff travel, etc.) in the "Training Related Expenses." Provide details on level of effort and salary of core leader/staff, description other expenses, etc. in the justification section.

Parts C, D, E, F, PHS 398 Cumulative Budget, and PHS 398 Subaward Budget Attachment(s): Follow "8.5. PHS 398 Training Budget" provided in the SF424 (R&R) Application Guide to complete these sections. Note: NRSA indirect cost rates do not apply to this FOA.

PHS 398 Research Training Program Plan (Training Core)

Follow "8.7. Research Training Program Plan Form" provided in the SF424 (R&R) Supplemental Instructions for Preparing Institutional Ruth L. Kirschstein National Research Service Award (NRSA) Application, with the following additional modifications:

(Note: NRSA Data Tables are not applicable to this FOA.)

Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for the Training Core component.

Background: Provide the rationale for the Training Core and the need for the cross-training proposed. Indicate how the Training Core will relate to current training activities at the applicant institution.

Program Plan: The Program Plan should be saved as a single pdf file and should consist of the following elements:

Program Administration: Describe the acknowledged strengths, leadership and administrative skills, training experience, scientific expertise, and active research of the Training Core Leader. Relate these strengths to the proposed management of the training core. Describe the planned strategy and administrative structure to be used to oversee and monitor the core.

Program Faculty: The application must include information about the Center faculty who will be available to serve as preceptors/mentors and provide guidance and expertise appropriate to the level of trainees proposed in the application. Describe the complementary expertise and experiences of the proposed Center Faculty, including active research and other scholarly activities in which the faculty are engaged, as well as experience mentoring and training individuals at the proposed career stage(s). For any proposed Center Faculty lacking research training experience, describe a plan to ensure successful trainee guidance by these individuals. Describe the criteria used to appoint and remove faculty as Center Faculty and to evaluate their participation.

Proposed Training: Provide an overview of the proposed Training Core. Outline the objectives of the core and the activities that will be used to meet these objectives. State the training level and proposed number of trainees. For postdoctoral trainees, indicate the proposed distribution by degree (e.g., M.D., Ph.D.). Describe course work and research opportunities, the extent to which trainees will participate directly in research, and the duration of training, i.e., usual period of time required to complete the training offered.

The Training Core should reflect the interdisciplinary nature of the overall research effort of the Center by enhancing cross-training of trainees in disciplines not traditionally linked with the university graduate structure. For instance, trainees pursuing degrees in the environmental science and engineering areas should be encouraged to understand how their research fits into the context of environmental health sciences and vice versa for biomedical trainees. Recommended Training Core activities have been listed in the Suggested Research and Activities document (see: http://www.niehs.nih.gov/research/supported/srp/funding/rfa.cfm). The description of the Training Core should include: 1) how the core will use interdisciplinary approaches to training; 2) how the core will provide trainees (i.e., graduate students and post-doctoral researchers) with opportunities to develop their current research/activities to enhance their own professional career development and to receive training on best practices in Responsible Conduct of Research; 3) how the core will coordinate opportunities for trainee participation in the Community Engagement and Research Translation Cores; and 4) how the core will report information about the Center’s trainees to the SRP. Note: it is not mandatory for trainees to participate in Community Engagement and Research Translation Core activities, but highly encouraged.

Program Evaluation: Describe a plan to review and determine the quality and effectiveness of the Training Core. This plan should include the utilization of NIH CareerTrac; metrics to be evaluated (including Training Core activities completed, degree completion, publications, fellowships/honors, and subsequent post-training positions); as well as plans to obtain feedback from current and former trainees to help identify weaknesses and to provide suggestions for program improvements. Specified evaluation metrics should be tied to the goals of the Center.

NIH CareerTrac database (https://careertrac.niehs.nih.gov/) supports tracking of trainee accomplishments - such as fellowships, awards, employment, other education, product or policy developments, publications, funding received, posters at scientific conferences, and students mentored. CareerTrac is intended to be a tool to enable NIH staff to evaluate the effectiveness and impact of its health research training programs and also to help NIH in overall coordination of its various research training programs. All trainees conducting research/activities supported by the Center (regardless if receiving direct support from the Training Core or other projects/cores) are considered SRP Trainees and should be entered into NIEHS CareerTrac. Applicants should identify the point of contact for entering data into the NIH CareerTrac database.

Trainee Candidates: Describe, in general terms, the size and qualifications of the trainee candidate pool including information about the types of prior research training. Give an indication of the academic disciplines/departments represented among the trainees. As applicable, describe specific plans to recruit candidates from diverse backgrounds and explain how these plans will be implemented (see also section on Recruitment and Retention Plan to Enhance Diversity). Describe the nomination and selection process to be used to select candidates and criteria for trainees reappointment to the Center.

Institutional Environment and Commitment to the Program: The sponsoring institution must assure support for the proposed Training Core including assurance that sufficient time will be allowed for the Training Core Leader and other Center Faculty to contribute to the proposed training. Institutions with ongoing research training, student development, or career development programs that receive external funding should explain what distinguishes the proposed Training Core from existing training programs at the same trainee level, how the programs will synergize, if applicable, whether trainees are expected to transition from one support program to another, and how the training faculty, pool of potential trainees, and resources are sufficiently robust to support the proposed training in addition to existing ones.

Timeline and Milestones: The Training Core description should include a timeline with milestones. This should indicate the frequency for trainee information submission/updates to the NIH CareerTrac database.

Relation to Overall Center: The Training Core should also include a "Relation to Overall Center" statement within the Program Plan. In this statement, clearly state the relevance of the core to the goals of the overall Center, how this core integrates with other projects and cores, and how the findings/activities of this core assist in solving the problem(s) that the Center is addressing.

For all applications, the core should identify a plan for communication with the Research Translation Core and the Administrative Core to provide information about trainee publications, activities, awards, and accomplishments, to ensure that this information is being communicated to SRP staff and to the public.

Recruitment and Retention Plan to Enhance Diversity: Individuals are required to comply with the instructions for Recruitment and Retention Plan to Enhance Diversity as provided in Chapter 8 of the SF424 (R&R) Application Guide. Applications must include a description of plans to recruit a diverse trainee pool and may wish to include data in support of past accomplishments. Information should be included on both successful and unsuccessful recruitment strategies. Applications lacking a diversity recruitment and retention plan may be delayed or not accepted for review, and an award cannot be made if an application lacks this plan.

Plan for Instruction in the Responsible Conduct of Research: Individuals are required to comply with the instructions for Plan for Instruction in the Responsible Conduct of Research as provided in Chapter 8 of the SF424 (R&R) Application Guide.

Progress Report (Renewal Applications Only): Renewal applications should provide a "Trainee List". In the "Trainee List", it is important that the application identifies the students and post-doctoral researchers who participated in the Training Core during the previous funding cycle. This list should be in tabular form and should include the names of the trainees, their SRP Center-associated mentor name, and project/core. Also, please indicate in the application that the trainee information has been entered into NIH CareerTrac database: https://careertrac.niehs.nih.gov/.

Data Tables: Not Applicable.

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.

SRP Centers may choose to include Research Support Core(s) to provide essential, centralized services or resources that will result in an economy of effort and/or savings to the overall costs of a Center. They can also serve as a useful tool in promoting interdisciplinary activities. When proposed by a Center, a Research Support Core must support at least two or more research projects. Typical core facilities include laboratory facilities, biostatistics and/or bioinformatics support, data management, or analytical equipment and services.

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 (Research Support 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 (Research Support Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information Component (Research Support 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.

Summary/Abstract: Include a Core Summary/Abstract that briefly describes how the Research Support Core will support the Center. The summary should highlight specific activities, innovative plans, and unique capabilities of the core indicating how its objectives have been tailored to fit the overall goals of the Center.

Project Narrative: It should be clear in the "Project Narrative" (i.e. the "public health relevance" statement) the relevance of the core activities to public health and to SRP stakeholders. SRP’s primary stakeholders are its sister Superfund programs at the U.S. Environmental Protection Agency (EPA) and Agency for Toxic Substances and Disease Registry (ATSDR). Additional stakeholders include other Federal agencies, State, local, and Tribal entities impacted by hazardous substances.

Project /Performance Site Location(s) (Research Support Core)

List all performance sites that apply to the specific component (e.g., all collaborating organizations and study sites).

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 Support Core)

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

PHS398 Research Plan (Research Support Core)

Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for each component.

Specific Aims: Specific Aims should describe the objectives and goals of the Core. The specific aims section should also contain a brief statement about how the Core integrates with the rest of the Center.

Research Strategy: In the Research Strategy, the applicant must include the description of the core, the services to be rendered, the methodological approaches to be used, and a plan for prioritizing the use of the facility by Center members. 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. Be certain to reference relevant tables (e.g. "Table of Research Support Core Utilization," described above). A Research Support 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 project in the Center.

In the Research Strategy section, Research Support Cores that provide analytical, quantitative services to the applicant’s Center should include a Quality Assurance Section. The Quality Assurance Section documents a Center's policy on implementing and assessing the effectiveness of its quality assurance and quality control operations. General guidance can be found at http://www.epa.gov/ncer/guidance/guidanceqmps0607.pdf. For more detailed guidance, see EPA Requirements for Quality Management Plans (EPA QA/R-2) on the EPA website at http://www.epa.gov/quality/qs-docs/r2-final.pdf.

The Quality Assurance Section should include the following items such as:

• How the core's activities will be reviewed and evaluated both internally and externally to ensure quality, including any plans for peer or other reviews of the study design or analytical methods prior to data collection and how recommended changes will be implemented.
• How a project's staff will be trained to implement quality assurance, and who will be responsible for training.
• How data will be analyzed (i.e., data/statistical analysis methods and references to software).
• A brief description of calibration procedures and performance evaluation of all analytical instrumentation.
• Discussion of any computer models to be designed or utilized with associated verification and validation techniques.
• Description of procedures for the handling and custody of samples, including sample collection, identification, preservation, transportation, and storage.
• How data will be managed (collected, backed-up, collated, transferred, stored, documented, and shared as appropriate).

Progress Report for Renewal Applications: For renewals, summarize activities carried out during the preceding performance period. Include core utilization by the individual Research Projects.

The Research Support Core should also include a "Relation to Overall Center" statement. In this statement, clearly state the relevance of the core to the goals of the overall Center, how this core integrates with other projects and cores, and how the findings/activities of this core assist in solving the problem(s) that the Center is addressing. Interactions with the Research Translation Core should also be included.

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.

Planned Enrollment Report (Research Support Core)

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

PHS 398 Cumulative Inclusion Enrollment Report (Research Support Core)

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

See Part I. Section III.1 for information regarding the requirements for obtaining a Dun and Bradstreet Universal Numbering System (DUNS) Number and for completing and maintaining an active System for Award Management (SAM) registration. Part I. Overview Information contains information about Key Dates. 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.

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.

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.

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 by the Center for Scientific Review and responsiveness by the National Institute of Environmental Health Sciences, NIH. Applications lacking clear relevance to Superfund will be considered nonresponsive. Applications that are incomplete, noncompliant, and/or nonresponsive will be withdrawn without further consideration.

On December 14, 2015, from 1:00 - 2:00 PM EDT, a free informational webinar will be held to provide information about this FOA. Information about how to register for this web seminar can be found on the following website: http://www.niehs.nih.gov/research/supported/dert/programs/srp/funding/rfa/index.cfm.

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.

Important Update: See NOT-OD-16-006 and NOT-OD-16-011 for updated review language for applications for due dates on or after January 25, 2016.

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.

For this particular announcement, each application will be evaluated both on the basis of the overall impact of the application as a whole and the overall impact of each of the individual components. Projects will receive individual impact scores and will also receive criterion scores on significance, investigators, innovation, approach, and environment. Cores will be evaluated based on the particular review criteria outlined in its section. Finally, the overall application will receive an overall impact score reflecting the reviewers' assessment of the Center's Significance, Investigator(s), Innovation, Approach, Environment, and Integration as well as the likelihood the Center will be successful in accomplishing its goals.

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. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a Center 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? 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?

Does the SRP Center address an important problem or critical barrier to our knowledge of human health effects, risks, detection, and mitigation of hazardous substances in the environment? Does the SRP Center have relevance to Superfund?

If successful, would the SRP Center provide data, information, and knowledge to inform the risk assessment and remediation management processes? If successful, would the SRP Center provide a rigorous scientific basis for effective decision-making? Will the Center further the knowledge of environmental health sciences to understand the physical, chemical and biological properties of hazardous substances in the environment?

If the Center were successful, would it lead to an incremental advance, or would it provide a substantial step forward?

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 Center? Do the experience and scientific leadership of the Center's Director (PD/PI) allow him/her to effectively direct a large complex multidisciplinary Center; and coordinate the interactions of the research projects with effective utilization of Cores to achieve programmatic goals? Is there evidence the Center Director has brought together complementary and integrated expertise, among research project and core leaders, to accomplish the goals of the Center?

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? Does the Overall SRP Center propose an innovative solution to critical barriers in the understanding of the physical, chemical, and biological properties of hazardous substances in the environment? Does the Center utilize novel theoretical concepts, approaches or methodologies, instrumentation, or interventions to solve complex problems associated with hazardous substances?

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

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 proposedWould the expected achievements of the Center be possible through mechanisms other than this multi-project Center?

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? Is there evidence of institutional support for the Center, including evidence of interdepartmental cooperation in order to carry out the multi-disciplinary activities of the Center?

Integration of the SRP Center

Does the Center propose to integrate projects and cores to target problem(s) within SRP's mandate areas? Is there evidence that interaction between projects and cores is necessary or ideal to resolve the problem the Center proposes to address? Is there evidence of integration and interaction of the biomedical related research with the environmental science- and engineering-based research as it contributes to the accomplishment of Center goals? Is there evidence of integration of the Administrative, Research Translation, Community Engagement and Training Cores with the Research Projects (and Research Support Cores, if applicable)? Is there evidence for the translation and delivery of the research findings to appropriate audiences?

Is there strong synergy among the combined efforts of the various investigators within the overall Center? Are the size and structure of the Center sufficient to afford effective interaction focused on a specific central theme, but diverse enough in scientific disciplines in order to achieve meaningful contributions to protecting human health and the environment?

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.

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 five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. 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.

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the Center.

For Renewals, the committee will consider the progress made in the last funding period.

Is there evidence of progress and achievements specific to this Center since the previous competitive review? Is there documentation through publications and conferences that demonstrates that collaboration between or among projects has occurred? Is there evidence of integration and synergy among the projects and cores within the Center? Is there evidence that the cores have met their objectives and been well utilized by the individual research projects? Is there adequate justification for adding new projects or cores or for deleting components previously supported?

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 .

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

In addition to the Overall Impact score for the Center, reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Reviewers will provide an overall impact score to each project in consideration of the five Scored Review Criteria (Significance, Investigator(s), Innovation, Approach, and Environment) and its contribution to Overall SRP Center (see Additional Review Criteria for all Projects and Cores). A separate score will be given for each of the five scored review criteria as part of the determination of scientific merit. A project 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. The Contribution to Overall SRP Center criterion is not scored separately, but is considered in the determination of the overall impact score of the project.

Significance (Research Projects)

Does the project address an important problem or a critical barrier to progress in the field? 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?

If the study is successful, would it lead to incremental advance, or would it provide a substantial step forward that would likely not be achieved through mechanisms other than this multi-project Center? If successful, will the project result in knowledge or resources that could be utilized to improve human health, risk assessment, or improve the quality of the environment? If successful, would the project provide data, information, and knowledge to inform the processes of risk assessment or remediation management? Will the project provide rigorous scientific data that might be used for effective decision-making by stakeholders? Does the project have relevance to Superfund?

Investigator(s) (Research Projects)

Are the project investigators (i.e. lead investigator for the project), 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 multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Innovation (Research Projects)

Does the project 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?

Does the project propose an innovative solution to a critical barrier to progress in the understanding of the physical, chemical and biological properties of hazardous substances in the environment?

Approach (Research Projects)

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

If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?

If the project involves research on hazardous waste sites or nearby communities, is a plan proposed to involve the appropriate Federal, State, or Tribal agency?

For each project, does the Investigator-Initiated Research Translation Plan" describe how research translation will be conducted? Do the Project investigators have a plan to work in conjunction with the Research Translation Core to identify appropriate research translation opportunities?

Environment (Research Projects)

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?

Each Core will be reviewed based on its criteria below and its contribution to the Overall SRP Center (see "Additional Review Criteria - Research Projects and Cores below). Each core will not receive criterion scores.

Review Criteria Specific to Administrative Core

Are the objectives of the Administrative Core appropriate to the Center? Are the approaches and methods proposed adequate to achieve objectives? Do the Administrative Core objectives reflect the interdisciplinary nature of the Center? Is there evidence that the lines of authority and the administrative structure are designed for effective management and leadership of the Center? 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? Does the core ensure that updates will be made to the SRP Data Collection Form and to the NIH CareerTrac database, and has the core designated points of contact responsible for reporting this information, as well as a plan for frequency of reporting? Is there evidence of an internal plan to promote integration and coordination? Does the Center’s internal plan promote coordination of interdisciplinary research and stimulate collaborations among constituent research projects and cores, particularly with regard to biomedical and environmental science and engineering project interactions? Are interactions between projects, cores, and external partners/communities evident? Is there an appropriate plan to establish and use an external advisory committee? Do the members of the committee have the expertise required to evaluate all projects and cores and appropriately represent the applicant’s stakeholders including US EPA or ATSDR (as applicable to renewal applicants)? For new applications, are the appropriate areas of expertise identified for the proposed External Advisory Committee? Does the senior leadership have appropriate experience and have they demonstrated effective and responsible leadership in the past? 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? If applicable, is the role of the Deputy Director appropriate for the Administrative Core and does their expertise contribute to the Center?

Review Criteria Specific to Research Translation Core

Are the objectives of the Research Translation Core appropriate to the Center? Are the approaches and methods proposed adequate to achieve objectives? Does the Research Translation Core promote and/or enhance interactions among the Center components and identify research translation opportunities on a per-project basis (i.e., investigator-initiated research translation)? Are the qualifications of proposed personnel adequate to conduct the activities described for the core? Do proposed personnel have the appropriate science and policy background to effectively translate findings from all research projects? Do they have an established track record for effectively working with science and public health experts, as well as communities (as applicable)? Is there a plan for communicating with the SRP at NIEHS and with other SRP RTCs? Is there a plan for coordinating with the Administrative Core, Community Engagement Core, Training Core, and Research Support Cores (as applicable)? Is the proposed plan to partner with governmental agencies adequate? Does the proposed plan specify bi-directional interactions? For renewal applications, is there evidence that the aims of the Research Translation Core have been met for developing approaches for transferring research findings to appropriate audiences (e.g., EPA, EPA Regions, ATSDR, State and local professionals or other professionals) working in the field of hazardous waste management? Is there evidence that the transfer of research findings to these audiences has occurred? Is the proposed plan to identify technology transfer opportunities and to assist in the advancement of technologies into application appropriate? Is the proposed plan to communicate to broad audiences adequate? Is there a plan for identifying and engaging target audiences? Are there adequate commitment and support for the approach being developed? Are the communication tools selected appropriate for the intended audience? Are milestones delineated, realistic, and appropriate?

Review Criteria Specific to Community Engagement Core

Does the Core highlight specific and appropriate prevention and intervention activities tailored to fit the overall goals of the Center and complement the Center’s research? Is the community of interest clearly defined? Are the community's and academic partners' roles clearly described? Is there evidence of the community's acceptance as a partner in the core? Is the community an integral part of the activity? Is the approach appropriate according to community socioeconomic and cultural factors? Are the objectives of the core of high interest/priority to the community? Will the core 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 community participation? Does the investigator provide previous experience/evidence for conducting community engagement activities? Does the research environment enhance the likelihood of success?

The Training Core score will be based on review criteria below and its Contribution to the Overall SRP Center (see "Additional Review Criteria - Research Projects and Cores below). The Training Core will not receive criterion scores.

Training Program and Environment (Training Core)

Are the objectives, design, and direction for the training appropriate to the Center? Are the approaches and methods proposed adequate to develop training curriculum, courses, and collaboration that provide the trainees with opportunities to interface with different disciplines? Does the Training Core reflect the interdisciplinary nature of the Center? Is the institutional commitment adequate? Are the quality of the facilities and the availability of courses appropriate to the Center? Is there an availability of research support for graduate and post-doctoral training?

Training Leadership (Training Core)

Does the Training Core Leader demonstrate experience in the development of training programs? Does the Training Core Leader encourage the trainees to participate in professional development and/or leadership opportunities? Does the Training Core Leader appear to devote adequate time to the trainees while balancing his/her own professional duties as a researcher/administrator? Does the Training Core Leader provide a plan for communicating with SRP about its training activities and providing information about the trainees to the SRP, such as trainees scientific or related fields, their academic and professional careers, and their leadership skills and experiences?

Preceptors/Mentors (Training Core)

Do the Preceptors/Mentors (e.g. Center Project Leaders and Core Leaders involved in Training Core) have strong records as researchers, including recent publications and successful competition for research support in areas directly related to the proposed research training core? Are appropriate plans in place to ensure that preceptors lacking sufficient research training experience are likely to provide strong and successful mentoring?

Trainees (Training Core)

Are plans for the recruitment and selection of graduate students and post-doctoral researchers appropriate? Are all the trainees either directly supported by the Center or performing research/activities supported by the Center listed within the Training Core?

Training Record (Training Core)

How successful are the trainees (or, for new applications, other past students/postdoctorates in similar training) in completing the program? Has the training program ensured that trainees are productive (or, for new applications, other past students/postdoctorates in similar training) in terms of research accomplishments, publication of research conducted during the training period, and subsequent training appointments and fellowship or career development awards? How successful are the trainees (or, for new applications, other past students/postdoctorates in similar training) in achieving productive scientific careers as evidenced by successful competition for research science positions in industry, academia, government or other research venues; grants; receipt of honors, awards, or patents; high-impact publications; promotion to scientific leadership positions; and/or other such measures of success? To what extent do trainees subsequent positions in industrial, academic, government, non-profit, or other sectors benefit from their NRSA-supported research training and directly benefit the broader biomedical research enterprise? Does the program propose a rigorous evaluation plan to assess the quality and effectiveness of the training (e.g., use of NIH CareerTrac)? Are effective mechanisms in place for obtaining feedback from current and former trainees?

Are the objectives of the Research Support Core(s) appropriate to the Center? Are the approaches and methods proposed adequate to achieve objectives? Does the Research Support Core promote and/or enhance interactions among the Center components? Does each Research Support Core provide essential facilities or service for two or more of the Research Projects? Is the projected use sufficient to warrant establishment of the core? Are the core facilities 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 core facilities/services? Does the staff have the appropriate experience and level of commitment?

As applicable for the project/core 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.

Contribution to SRP Center (applies to all Projects and Cores)

Does the project/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)?

Will the specific scientific objectives of each project/core benefit significantly from, or depend upon, collaborative interactions with other projects in the Center (i.e., objectives that can be uniquely accomplished, specific contributions to the accomplishments of objectives in other projects, and objectives that can be accomplished with greater effectiveness and/or economy of effort)?

Protections for Human Subjects

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 Human Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children

When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. 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

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Renewals

For Renewals, the committee will consider the progress made in the last funding period.

Training Cores: For renewal applications with a previously funded "Training Core", is the tracking of trainees (e.g. in CareerTrac) adequate and have they demonstrated commitment to tracking/reporting trainee accomplishments?

As applicable for the project/core 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/priority score.

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) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genomic Data Sharing Plan. For research projects, the reviewers will comment on whether the "Investigator-Initiated Research Translation" plan is reasonable.

Recruitment & Retention Plan to Enhance Diversity (Training Core)

Peer reviewers will separately evaluate the recruitment and retention plan to enhance diversity after the overall score has been determined. Reviewers will examine the strategies to be used in the recruitment and retention of individuals from underrepresented groups. The plan will be rated as ACCEPTABLE or UNACCEPTABLE, and the consensus of the review committee will be included in an administrative note in the summary statement.

Training in the Responsible Conduct of Research (Training Core)

All applications for support under this FOA must include a plan to fulfill NIH requirements for instruction in the Responsible Conduct of Research (RCR). Taking into account the specific characteristics of the training core, the level of trainee experience, and the particular circumstances of the trainees, the reviewers will evaluate the adequacy of the proposed RCR training in relation to the five instructional parts outlined in the NIH Policy on Training in the Responsible Conduct of Research: format, subject matter, faculty participation, duration, and frequency. Plans will be rated as ACCEPTABLE or UNACCEPTABLE, and the summary statement will provide the consensus of the review committee.

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.

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 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 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.

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.

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.

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.

Cooperative Agreement Terms and Conditions of Award

Not Applicable

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.

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

eRA Commons Help Desk (Questions regarding 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
Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
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

Danielle Carlin, Ph.D., DABT
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-541-1409
Email: [email protected]

Michelle Heacock, Ph.D.
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-541-7824
Email: [email protected]

Heather Henry, Ph.D.
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-541-5330
Email: [email protected]

William A. Suk, Ph.D., MPH
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-541-0797
Email: [email protected]

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

Lisa Archer Edwards, M.B.A.
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-541-0751
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 Superfund Amendments and Reauthorization Act of 1986, Title I, Section III, and Title II, Section 209, Public Law 99- 499, as amended; Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) of 1980, as amended, Section 311(a), Public Law 96-510; Public Health Service Act, Section 301, Public Law 78-410, as amended; Public Law 99-500. In addition, 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 Parts 74 and 92; and under the authority in 42 CFR 65.5.