Part 1. Overview Information

 

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute of Environmental Health Sciences (NIEHS)

Funding Opportunity Title

Superfund Hazardous Substance Research and Training Program (P42 Clinical Trial Optional)

Activity Code

P42 Hazardous Substances Basic Research Grants Program

Announcement Type

Reissue of RFA-ES-18-002

Related Notices
None 
Funding Opportunity Announcement (FOA) Number

RFA-ES-20-014

Companion Funding Opportunity

None

Number of Applications

Only one application per institution is allowed. See Section III. 3. Additional Information on Eligibility.

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.143  

Funding Opportunity Purpose

The National Institute of Environmental Health Sciences (NIEHS) is announcing the continuation of the Superfund Hazardous Substance Research and Training Program, referred to as Superfund Research Program (SRP) Centers. SRP Center grants will support problem-based, solution-oriented research Centers that consist of multiple, integrated projects representing both the biomedical and environmental science and engineering disciplines; as well as cores tasked with administrative (which includes research translation), data management and analysis, community engagement, research experience and training coordination, and research support functions.  The scope of the SRP Centers is taken directly from the Superfund Amendments and Reauthorization Act of 1986, and includes: (1) advanced techniques for the detection, assessment, and evaluation of the effect on human health of hazardous substances; (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.

Key Dates

 

Posted Date

September 2, 2020

Open Date (Earliest Submission Date)

January 15, 2021]

Letter of Intent Due Date(s)

January 15, 2021

Application Due Date(s)

February 15, 2021

All applications are due by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on the listed date(s). Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

July 2021

Advisory Council Review

January 2022

Earliest Start Date

April 1, 2022

Expiration Date

February 16, 2021

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the Multi-Project (M) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.


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

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



  3. Table of Contents

    Part 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


    Part 2. Full Text of Announcement
    Section I. Funding Opportunity Description

    Research Objectives

    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 biomedical research (e.g., toxicology, epidemiology, mechanistic studies) with environmental science and engineering (e.g., remediation, geochemical, ecological sciences). The goal of an NIEHS SRP Center is to improve public health by supporting integrative, multidisciplinary research incorporating the following: responsiveness to mandates; problem-based, solution-oriented research; relevance to SRP and Superfund; innovation; and integration. 

    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 teams with expertise in biomedical science as well as environmental science and engineering to advance knowledge using innovative and integrated approaches. Moreover, the SRP's fourth mandate reinforces the program's problem-solving mission; whereby, the research generated by SRP Centers would lead to strategies to prevent exposure and/or develop intervention strategies to improve public health. As such, Centers are expected to facilitate transfer of research findings through coordinated data management and analysis; engage communities with prevention/intervention strategies; share findings to broader audiences; and train the future generation of scientists.

    Problem-based, Solution-oriented Research Theme: As an integrated research program, SRP Centers can 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 problem (or set of problems) related to SRP’s mandates: health effects, risk, detection, and remediation/mitigation of hazardous substances.  

    Relevance to SRP and Superfund: Given SRP’s broad mandates, it is important for interdisciplinary teams to work together to identify research that addresses relevant exposure pathways. Ultimately, problem-solving research seeks to find answers to inform real-life exposures – both in terms of understanding health implications as well as developing remedies for these exposures. For example, basic research generates mechanistic knowledge upstream of its application, but this research should be contextualized in terms of its relevance to environmental exposures. Furthermore, there is an expectation that interdisciplinary teams have considered multiple vantage points in devising their research approach – showing evidence of crosstalk between health, environmental, and exposure research expertise. For these reasons, applicants should assemble teams to address research challenges within a given mandate area, contaminant, or exposure scenario that may have the greatest potential for supporting the SRP's goal of protecting human health and the environment from the impact of hazardous substances.

    The SRP also considers the diverse research and information needs of its stakeholders as important criteria for determining relevance. SRP stakeholders include the Superfund programs at the U.S. Environmental Protection Agency (EPA, https://www.epa.gov/superfund) and Agency for Toxic Substances and Disease Registry (ATSDR, https://www.atsdr.cdc.gov). In addition, agencies such as the National Oceanic and Atmospheric Administration (https://www.noaa.gov), U.S. Geological Survey (https://www.usgs.gov), U.S. Department of Defense (https://www.defense.gov), and the U.S. Department of Energy (https://www.energy.gov) are important stakeholders and/or end-users of research and technology to manage and mitigate sites impacted by hazardous substances. In addition, the National Science Foundation (https://www.nsf.gov) and other NIH Institutes and Centers (https://www.nih.gov/institutes-nih/list-nih-institutes-centers-offices), may provide valuable opportunities to promote and leverage the findings of SRP research. The SRP also considers, as important stakeholders, state, local, and Tribal governments, and communities impacted by hazardous substances. The 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 minimize risk and remediate sites impacted by hazardous substances. Therefore, investigators should seek input from stakeholders during application development and identify critical issues for which fundamental science is needed. 

    Moreover, Centers are expected to demonstrate the following:

    Innovation: The SRP strives to push the boundaries of science using the newest technologies and challenging current scientific paradigms. The 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 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 or devising more sustainable solutions to address issues associated with hazardous substances.

    Integration: Addressing the complex challenges posed by environmental contamination requires an integrated, multidisciplinary approach. The SRP considers integration of a Center's projects and cores as an important way to target complex problem(s) relevant to the SRP's mandates. A Center should demonstrate evidence of integration between its projects and cores - including interaction between biomedical and environmental science and engineering disciplines. Through effective interactions of its components, the Overall Center demonstrates a systems approach to problem-solving. In addition, the research emanating from the Center and the interaction between the projects and cores should be incorporated into sustainable solutions that consider environmental, social, and economic issues – also referred to as a systems approach.

    To achieve a broad and sustained impact, SRP Centers are expected to include the following:

    Research Projects: Collectively, the Center's research projects (maximum of six) 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 each project should have the necessary biomedical and/or environmental science and engineering expertise to address the central problem.

    Biomedical Research (BMR) Projects: A minimum of two (maximum of four) BMR projects are required and should address biomedical or human health-related implications of hazardous substances. This includes but is not limited to: toxicology studies, epidemiology, mechanistic studies, genetic susceptibility, computational toxicology, biomedical engineering, preclinical/clinical intervention, or efficacy of prevention studies. Each BMR project should clearly contribute to the overall Center objective, providing a clear step towards identifying solutions to the problem. Projects should be hypothesis-driven or product-oriented research.

    Environmental Science and Engineering (ESE) Projects: A minimum of two (maximum of four) ESE projects are required and 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. ESE projects include, but would not be limited to: remediation, geochemical, ecological, civil/environmental engineering, geology, microbiology, fate and transport studies, hydrogeology, and detection sciences. Each ESE project should clearly contribute to the overall Center objective, providing a clear step towards identifying solutions to the problem. Projects should be hypothesis-driven or product-oriented research. The SRP recognizes the importance of new environmental science and engineering approaches to reduce the amount and toxicity of hazardous substances in the environment. Fostering the development of novel remediation approaches – through designing new remediation platforms or assessing the efficacy of these platforms – is an important contribution to accelerating the cleanup of hazardous substances and preventing exposures. For this reason, all applicants are required to include at least one environmental science and engineering project that supports SRP’s fourth mandate “basic biological, chemical, and physical methods to reduce the amount and toxicity of hazardous substances.” 

    (Please see the "Suggested Research and Activities" document for more information about research areas of interest to the SRP: https://www.niehs.nih.gov/research/supported/centers/srp/assets/docs/srp_funding_opps_suggested_research_and_activities_508.pdf)

    Data Management and Analysis: The SRP acknowledges that integration of data from a broad range of scientific disciplines will be critical to understanding and breaking the link between exposures and disease. In addition, proper data stewardship is needed to ensure that data is treated as a valuable research asset. To support NIH data sharing policies (https://grants.nih.gov/policy/sharing.htm) and promote best principles so data is Findable, Assessible, Interoperable, and Reusable (FAIR), all applicants are required to have a Data Management and Analysis Core (DMAC). The primary purpose of the DMAC is to support the management and integration of data assets across the Center.  In addition, the DMAC should support and facilitate the management of data assets, irrespective of dataset size. The DMAC should also establish, coordinate, and monitor processes for data analysis and work closely with project/core leaders to ensure high data quality throughout the entire lifecycle of the data. The DMAC also has a coordinating role to work with project/core leaders to identify opportunities for integrating project/core-generated data with other existing datasets. The DMAC should also foster and enable the interoperability of data between biomedical and environmental science and engineering projects, accelerating the impact of the Center's research.  

    Community Engagement: The SRP views Community Engagement as an effective way to inform and advance science for public health protection. In addition, the 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. Therefore, all applicants are required to include a Community Engagement Core (CEC). The purpose of the CEC is to ensure bidirectional communication between the CEC and the community and to direct best practices and activities 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, CEC activities should address prevention/intervention defined by SRP's fourth mandate 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. The CEC activities should also complement the research strengths and problem-solving goals of the Center. 

    Administrative and Research Translation Functions: The SRP requires an Administrative Core in each SRP Center grant application.  This core leads the Center, maintains the organization of the Center, and ensures that the projects and cores are being supported to achieve the Center’s goals.  In addition, the SRP is committed to fostering translation of scientific accomplishments to support its mandates and 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.” Therefore, all applicants are required to include research translation as part of the Center's Administrative Core to facilitate and coordinate communication of the results, accomplishments, and implications of the Center’s research to stakeholders, including NIEHS SRP staff, to other SRP Centers, and other applicable stakeholders in a context that makes the research applicable to the target audience. Additionally, the SRP Strategic Plan highlights the importance of investigator-initiated research translation (IIRT); therefore, the Administrative Core has the critical role in assisting project/core leaders in translating their research outcomes and activities to appropriate audiences and ensuring the accurate and timely use of products and sharing of findings.   

    Training: The SRP regards research and training as vital components to the development of the next generation of environmental health science professionals. Therefore, the SRP requires applicants to include a Research Experience and Training Coordination Core (RETCC) to coordinate graduate and postdoctoral level cross-disciplinary research experiences and training in fields related to biomedical research and environmental science and engineering research. SRP mandates specify graduate level training (e.g., Masters, PhD., Post doc); therefore, the SRP defines "trainees" within the program as graduate students and post-doctoral researchers that perform research/activities that are supported by the Center. The RETCC 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. (Note: While undergraduates are recognized as a part of the research continuum and allowed to participate in RETCC activities, the RETCC should direct its opportunities for training, integration, and professional development among the graduate and post-doctoral level trainees within the Center.)

    Applicants are encouraged to refer to the SRP’s 2020-2025 Strategic Plan (https://www.niehs.nih.gov/research/supported/centers/srp/about/strat_plan/index.cfm) which describes and defines the objectives and goals of the SRP in order to address its mandates. In addition, the SRP Mandates are provided on the following website: https://www.niehs.nih.gov/research/supported/centers/srp/about/index.cfm. In addition, applicants are encouraged to refer to the NIEHS 2018-2023 Strategic Plan: https://www.niehs.nih.gov/about/strategicplan/2018-2023_theme3/index.cfm.

    Scope of the SRP Center Grant

    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.

    The 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. The SRP encourages biomedical research that dissects the molecular, genetic, epigenetic, and biochemical events that describe the normal physiological processes that contribute to good health and the roles that hazardous substances play in their disruption and the progression of disease. The SRP also encourages biomedical research that examines the cumulative impacts of combined exposures of hazardous substances and how they interplay with biological responses and host factors (e.g., nutrition, co-morbid disease/conditions, lifestyle habits, psychosocial stressors; genetic polymorphisms, epigenetic factors, sex/gender, and age; timing of exposure, resilience, and allostatic load) that impact disease susceptibility. Application of advanced techniques to determine the contribution of genetic and environmental variables (i.e., GxE interaction) and highly innovative approaches such as high-throughput screening techniques, “-omics” approaches, next generation sequencing, humanized models, tissue engineering (including organotypic tissues), in silico modeling systems approaches; and systems biology approaches are also desired. Discovery and validation of technologies useful for exposure assessment, indicators of biological response (e.g., biomarkers of exposure and disease), and disease susceptibility are important research activities with translational opportunities. 

    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 and transport; transformation of contaminants in the environment; contaminant bioavailability in the environment and in biological systems; identifying biomarkers of exposure; and quantifying body burden. The SRP also recognizes the need for developing novel methods/approaches/statistical models to integrate exposure over time, determining windows of susceptibility, 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 stressors (e.g., infectious disease, psychosocial), indirect effects, and mode of action to support more complex exposure assessments in susceptible populations (e.g., medically and economically disadvantaged). The SRP also recognizes the need to study exposure burdens that combine with other social determinants of health, such as age, sex/gender, education, race, and income, to create health disparities. Other methods needed to assess risk to hazardous substances include incorporation of the exposome, alterations of the microbiome, effects of single nucleotide polymorphisms (SNPs), use of Adverse Outcome, causal, and other pathway modeling, and consideration of macromolecular alterations (e.g., epigenetics). 

    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. Because site characterization can often 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., model organisms, passive sampling devices). Applicants are encouraged to develop sensor technologies applicable to complex media (e.g., soil, sediments, and groundwater). Tool designs should also consider 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 biomedical and environmental science and engineering research in the development of prevention and intervention strategies to improve human health by mitigating exposure and reducing toxicity of environmental contaminants. The SRP encourages biomedical research that identifies methods, mechanisms, and opportunities to reduce the health impact of hazardous substances among individuals who may have been exposed. For example, research investigating the mechanisms of nutrition, lifestyle, or other co-factors to mitigate toxicity has the potential to greatly improve public health. The SRP also places a high priority on environmental science and engineering research in technologies/approaches that reduce the amount and toxicity of hazardous substances; accordingly, there is a requirement for at least one environmental science and engineering project to support this mandate. The SRP encourages a continuum of research - from mechanistic to applied - to translate basic environmental science and engineering principles into feasible, efficient, and cost-effective technologies that reduce and/or eliminate contamination in media such as groundwater, sediments, fractured bedrock, soils, and/or drinking water. By devising new methods to clean up environmental toxicants, these remediation strategies reduce exposures and, hence, are a form of primary prevention to improve public health. Studies that validate or confirm risk reduction from these types of prevention or intervention activities also support the goals of understanding how to effectively reduce the amount and toxicity of hazardous substances. These types of studies may, for example, identify unintended toxicological consequences of a remediation technology, serving as a basis to improve such technologies. Furthermore, there are tremendous opportunities to engage and interact with communities by identifying effective intervention and prevention activities to reduce the amount and/or toxic impact of hazardous substances in their communities. Hence, the Community Engagement Core is required to pursue prevention and intervention goals related to this fourth mandate within the context of biomedical and/or environmental science and engineering approaches.

    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 stakeholders (e.g., the agencies responsible for management of sites impacted by hazardous substances, as well as the individuals and communities impacted by these sites). Hence, applicants are encouraged to engage stakeholders as they develop their research projects and cores to identify critical gaps in knowledge for which basic research is needed. For a listing of research areas of interest to the SRP and its stakeholders, please refer to the “Suggested Research and Activities” document on the following website (https://www.niehs.nih.gov/research/supported/centers/srp/funding/rfa/).

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

    Hazardous Substances: The SRP is not a site-specific program; however, in the broadest 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: https://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 to humans or in experimental animal models.

    The applicants should refer to the “Additional Resources” link on the following website (https://www.niehs.nih.gov/research/supported/centers/srp/funding/rfa/) for a list of hazardous substances, including emerging contaminants, that have been suggested for study by SRP stakeholders. 

    Applicants are highly encouraged to consult with SRP 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. The SRP will place priority 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 sites.

    Although the 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 water pollution, the SRP will place a higher priority on research with a clear connection to understanding exposures relevant to populations living near or affected by sites impacted by hazardous substances. Per SARA Mandates, hazardous substances do not include petroleum, natural gas, natural gas liquids, liquefied natural gas, or synthetic gas usable for fuel.

    Activities on 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 “Additional Resources” webpage accessible from the following website: (https://www.niehs.nih.gov/research/supported/centers/srp/funding/rfa/).

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

    NOTE: Applications whose only human subjects/clinical trials are surveys (i.e., conducted as a part of community engagement activities) may meet the definition of "delayed onset".  For more information and the definition of delayed onset, please see https://grants.nih.gov/grants/glossary.htm#DelayedOnsetStudy).

    Annual Meetings

    It is the intent of the NIEHS to hold annual grantee meetings. It is anticipated that the location of the meeting site will rotate among the different grantees and Research Triangle Park, NC. For more information, see Section IV. Application and Submission Information.

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

    Section II. Award Information
    Funding Instrument

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

    Application Types Allowed

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

    Clinical Trial?

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

    Need help determining whether you are doing a clinical trial?

    Funds Available and Anticipated Number of Awards

    NIEHS intends to fund an estimate of up to 12 awards based on programmatic needs and availability of funds, corresponding to a total of up to approximately $25 million, for fiscal year 2022. Future year amounts will depend on annual appropriations

    Award Budget

    Applications may request a budget for direct costs of up to $1.75 million dollars for each year.

    Award Project Period

    Applications may propose a project period of up to 5 years.

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

    Section III. Eligibility Information
    1. Eligible Applicants
    Eligible Organizations

    Higher Education Institutions

    • ·        Public/State Controlled Institutions of Higher Education
    • ·        Private Institutions of Higher Education

    The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

    o   Hispanic-serving Institutions

    o   Historically Black Colleges and Universities (HBCUs)

    o   Tribally Controlled Colleges and Universities (TCCUs)

    o   Alaska Native and Native Hawaiian Serving Institutions

    o   Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

    Per NIEHS legislative authority, ONLY Higher Education Institutions may apply to 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, applicants 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; and/or State and local governments.

    Foreign Institutions

    Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
    Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

    Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

    Required Registrations

    Applicant Organizations

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

    • ·        Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
    • ·        System for Award Management (SAM) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
    • o   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 to register in eRA Commons. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration, but all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
    • ·        Grants.gov – Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

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

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

    Eligible Individuals (Program Director/Principal Investigator)

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

    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."

    2. Cost Sharing

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

    3. Additional Information on Eligibility
    Number of Applications

    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).
    Section IV. Application and Submission Information
    1. Requesting an Application Package

    The application forms package specific to this opportunity must be accessed through ASSIST or an institutional system-to-system solution. A button to apply using ASSIST is available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

    2. Content and Form of Application Submission

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

    Letter of Intent

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

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

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

    The letter of intent should be sent to:

    Laura Thomas, PhD
    Telephone: 984.287.3328
    Fax: 301-480-3705
    Email: laura.thomas@nih.gov  

    Page Limitations

    Available Component Types

    Research Strategy/Program Plan Page Limits

    Overall

    12

    Core (use for Administrative Core, Data Management and Analysis Core, Community Engagement Core, Research Experience and Training Coordination Core, and Research Support Core)

    12 each Core

    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.

    Instructions for the Submission of Multi-Component Applications

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

    The application should consist of the following components:

     Overall: required

     Research Projects: maximum of 6

    • ·    Biomedical Research Projects: required, minimum of 2; maximum of 4
    • ·    Environmental Science and Engineering Research Projects: required, minimum of 2; maximum of 4

     Cores: minimum of 4; maximum of 6

    • ·    Administrative Core: required
    • ·    Data Management and Analysis Core: required
    • ·    Community Engagement Core: required
    • ·    Research Experience and Training Coordination Core: required
    • ·    Research Support Core(s): optional, maximum of 2

    Note: Applications must successfully meet these minimum requirements (4 required projects, 4 required cores (Administrative Core, Data Management and Analysis Core, Community Engagement Core, and Research Experience and Training Coordination Core)) without exceeding a total of 11 projects and cores. At least one of the Environmental Science and Engineering Research Projects must support the SRP's fourth mandate: "Basic biological, chemical, and physical methods to reduce the amount and toxicity of hazardous substances."

    Overall Component

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

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

    SF424 (R&R) Cover (Overall)

    Complete entire form.

    PHS 398 Cover Page Supplement  (Overall)

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

    Research & Related Other Project Information (Overall)

    Follow standard instructions.

    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 and how the Center plans to solve 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 which hazardous substances are being evaluated, study sites, research approaches, model organisms/biological systems, disease pathways, etc. In addition, the summary 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 and reducing disease/dysfunction) should also be included. Note: the project summary should be written in plain language for a diverse set of reviewers while providing a depth of understanding of the science and activities of the Center.

    Project Narrative: It should be clear in the "Project Narrative" (i.e., the "public health relevance" statement) the relevance of the Center’s activities to public health, SRP stakeholders, Superfund, and the Superfund Research Program. 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 stakeholders (e.g., the agencies responsible for management of sites impacted by hazardous substances, as well as the individuals and communities impacted by these sites).

    Other Attachments: The following "Other Attachments" should be included with the overall component 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. In this diagram, applicants should clearly indicate which projects are biomedical and which are environmental science and engineering. Applicants are encouraged to use a systems approach to represent the linkages between projects/cores. The diagram should be provided as a pdf file titled "Center Organizational Structure."  

    ·        Table of Integration with Center. To assist the reviewers in determining the relationship between components, a table should be provided showing interactions between projects and cores and why (e.g. the purpose of the interaction) for the achievement of the Center's overall objectives. Applicants are encouraged to use a systems approach to identify problem-solving leverage points the Center will address. This table should be provided as a pdf file titled "Table of Integration with Center."

    ·        Table of Stakeholders and Field Sites. To assist the reviewers in identifying significant project and core interactions with key stakeholders and field sites, a table should be provided showing which projects and cores interact with which stakeholders/field sites as well as the type of interaction/activity. Stakeholders would include local/state/federal government organizations, non-government organizations, community organizations/groups, other end-users) with significant ongoing and/or planned interactions. Field sites would include Superfund or other hazardous waste sites or other study/research sites. This table should be provided as a pdf file titled "Table of Stakeholders and Field Sites."

    ·        Table of Research Support and Data Management and Analysis Core Utilization. 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. Centers may include the Data Management and Analysis Core in this table. This table should be provided as a pdf file titled "Table of Research Support and Data Management and Analysis Core Utilization."

    ·        Table of Changes to Projects and Cores. To assist review of renewal/resubmission applications, a table should be included that lists projects and core components (by project title and project/core leader) denoting 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, the applicant should indicate which projects are considered biomedical research and which are considered environmental science and engineering research (including which environmental science and engineering project addresses SRP's fourth mandate). ASSIST assigns projects/cores consecutively; therefore, when numbering projects and cores, numbering must 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 provided as a pdf file titled "Table of Changes to Projects and Cores".

    ·        Table of Research Approaches. 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 provided as a pdf file titled "Table of Research Approaches."

    Please refer to the following website for example illustrations of the tables: https://www.niehs.nih.gov/research/supported/centers/srp/funding/rfa/rfa_tips/index.cfm.

    Project/Performance Site Location(s) (Overall)

    Enter primary site only.

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

    Research & Related Senior/Key Person Profile (Overall)

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

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

    Budget (Overall)

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

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

    PHS 398 Research Plan (Overall)

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

    Specific Aims: Applicants must 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 will 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. As part of their Specific Aims, applicants are encouraged to use a systems approach to identify problem-solving leverage points the Center will address. The Specific Aims section should provide greater scientific detail and approaches than the overall Project Summary/Abstract.  For example, 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: The Research Strategy section for the Overall Center should highlight the significance of the Center's overall goals relative to the SRP Mandates, the group expertise of the research team to accomplish the goals (without duplicating information in biosketches), the innovation of the science, and the strengths of the experimental approaches and the research environment. Centers should detail the integration between project and cores, with a focus on how the Overall Center is greater than the sum of its parts (i.e., components). As such, the following subsections are recommended: Significance and Relevance to SRP Mandates and Superfund; Research Team; Innovation, Approach; Environment; and Center Integration.   

    Significance and Relevance to SRP Mandates and Superfund: Applicants should include an overview of the Center that clearly describes 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. Applicants are encouraged to consider a systems approach in outlining the interactions and problem-solving efforts of the Center as a whole, identifying where the SRP research can make a big impact in reducing the burden of disease/dysfunction from exposure to hazardous substances (i.e. leverage points). 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 stakeholders (e.g., the agencies responsible for management of sites impacted by hazardous substances, as well as the individuals and communities impacted by these sites). Applicants should provide a clear description of how the hazardous substance(s) being studied and subsequent results are relevant to the SRP and 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. 

    Research Team: Applicants should introduce the leadership and key personnel of the Center, highlighting the breadth of disciplines interacting among the research projects and cores. In introducing the team, applicants may wish to identify which hazardous substances are being evaluated, study sites, research approaches, model organisms/biological systems, disease pathways, etc. per project and core. Applicants should report how complementary and integrated expertise among research project and core leaders accomplishes the goals of the Center. Applicants should report the successes and accomplishments of the team as a whole in advancing their respective field - particularly with regard to integration between disciplines. Applicants may want to include a brief description of plans for the Administrative Core to facilitate the overall goals of the Center and maintain organization of the Center. Applicants are encouraged to refer to the NIEHS 2018-2023 Strategic Plan highlighting enhancing the professional pipeline as well as promoting diversity in environmental health sciences:  https://www.niehs.nih.gov/about/strategicplan/2018-2023_theme3/index.cfm.

    Innovation, Approach, and Environment: A description of the innovative aspects of the Center should be included. Applicants should highlight novel theoretical concepts, approaches or methodologies, instrumentation, or interventions within the Center including novel adaptations of technologies from one field to another (transdisciplinary). Applicants should describe how the proposed innovative approaches lead toward a novel solution to critical barriers in the understanding of the physical, chemical, and biological properties of hazardous substances in the environment. Applicants should indicate how their strategies ensure a robust, unbiased approach. Also, it is important for applicants to highlight the degree to which the experimental designs recapitulate real world exposures. The applicant should highlight how the university environment supports the Center's problem-solving goals; provides institutional support; and/or enhances interdepartmental/interinstitutional cooperation needed to carry out the multi-disciplinary activities.

    Center Integration: 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 contribute to the Center’s theme; and how the Center will achieve the integration and interaction among biomedical and environmental science and engineering research. Applicants are encouraged to adopt a systems approach as a means to provide evidence of integration of projects with the Administrative, Data Management and Analysis, Community Engagement, and Research Experience and Training Coordination Core (and Research Support Cores, if applicable). The applicant should also cross-reference sections of the application that detail data management activities (i.e., Overall “Summary of Center Data Management and Analysis” in the Overall Resource Sharing Plan; the DMAC component; and Project/Core-Specific Data Sharing Plans) for evidence of integration between projects and cores and how data sharing enhances the impact of the Center’s research and activities.  Furthermore, they should highlight plans for the translation and delivery of the research findings to appropriate audiences, cross-referencing sections of the application that detail research translation (i.e. Administrative Core, and project/core “Investigator-Initiated Research Translation” plans located in the respective “Resource Sharing Plan” sections). Applicants should describe how the combined efforts of the various investigators enhance interactions to achieve meaningful contributions to protecting human health and the environment.  The applicant may wish to cross-reference other sections of the application where more detailed information is found. The Overall "Other Attachments" includes a diagram of the Center Organizational Structure; and tables for “Integration with Center,” “Stakeholder Engagement,” “Research Support Core Utilization,” “Changes to Projects and Cores” (as applicable); and “Research Approaches.” Other sections where interaction may be demonstrated include: the Administrative Core Research Strategy section, which details Center management and research translation activities; and the "Summary of Center Data Management and Analysis" found in the Overall Resource Sharing section.

    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/cores will also provide a “Progress Report” in their respective Research Strategy sections). This is the section where the achievements of the Center can be expressed/demonstrated. Items to be included are the following:

    Brief summary of major accomplishments of the Center in achieving its problem-solving goals.

    Brief highlights of integration and synergy among the projects and cores within the Center. Include references to publications and conferences that demonstrate collaboration between or among projects and cores. Brief report on projects and cores that are not being continued, and the reason for removing them from the Center. Be certain to reference relevant tables (e.g. "Table of Changes to Projects and Cores", described above).

    Timeline: Applicants should provide an Overall Center timeline for the completion of problem-solving goals as well as significant integrated activities between projects/cores. 

    Letters of Support: Applicants may include letters of support pertaining to the Overall Center.  For example, these letters may include collaborative agreements for the entire Center, institutional support (if applicable), etc. Letters of Support for each project and core should be placed in the respective project and core. See the Application Guide for instructions.

    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: For the Data Sharing Plan, applicants should provide a “Summary of Center Data Management and Analysis.” This summary should include a general description of the types of data expected to be generated from the Center, a synopsis of proposed data management/sharing activities. Applicants may wish to highlight anticipated integration opportunities between projects and cores.  Information included in this section should briefly summarize, but not duplicate, the component sections of the application, cross-referencing the DMAC and project/core Resource Sharing Plans for more detailed descriptions about data management, analysis, and sharing. 

    Appendix:

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

    PHS Human Subjects and Clinical Trials Information (Overall)

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

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

    Study Record: PHS Human Subjects and Clinical Trials Information

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

    Delayed Onset Study

    Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).

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

    PHS Assignment Request Form (Overall)

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

    Research Project Components

    The SRP requires a minimum of two Biomedical (BMR) and two Environmental Science and Engineering (ESE) Research Projects (maximum of 6 projects). (Note: at least one ESE project should address the SRP’s fourth mandate “basic biological, chemical, and physical methods to reduce the amount and toxicity of hazardous substances.”) The SRP accepts projects that range from basic to applied science. Applicants are encouraged to frame their research in terms of testable hypotheses. For research that is more applied or hypothesis generating, applicants should delineate tasks, with clearly stated benchmarks of success. Applicants should consider including alternative strategies in the event that the primary approach/methodology is unsuccessful.

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

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

    SF424 (R&R) Cover (Research Project)

    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 Project)

    Enter Human Embryonic Stem Cells in each relevant component.

    Research & Related Other Project Information (Research Project)

    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 Project Summary/Abstract that briefly describes the objectives of the project and how the project will support the problem-solving goals of the Center. Relate the project to the SRP's mandates (health effects, risk, detection and/or remediation of hazardous substances), drawing connections to Superfund, as appropriate. Provide details about the project such as the hazardous substances being evaluated, research approaches, and the exposure context (as appropriate). Include information about the model organisms/biological systems, disease pathways, environmental media, etc., as well as study sites (if applicable). In addition, the project summary should highlight aspects of the application that are innovative, paradigm-shifting, and/or gap-filling. Plans for engaging stakeholders or communities, if applicable, should be included. The project summary should provide 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 project’s activities to public health, SRP stakeholders, Superfund, and the Superfund Research Program. 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 stakeholders (e.g., the agencies responsible for management of sites impacted by hazardous substances, as well as the individuals and communities impacted by these sites).

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

    List all performance sites that apply to the specific component.

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

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

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

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

    PHS 398 Research Plan (Research Project)

    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. As applicable, applicants should denote specific aim(s) that represent a collaborative/shared effort between other projects and cores. The specific aims section should also include a brief statement about how the project integrates with the rest of the Center, describing how the project contributes to other projects and cores.     

    Research Strategy: The Research Strategy section should highlight the significance of the research project, the expertise of the research team, the innovation of the science, the details of their experimental approach (including a rationale for the methodology), the strengths of the research environment, as well as a description of how the project contribute to the Overall SRP Center.  As such, the following subsections are recommended: Significance and Relevance to SRP Mandates and Superfund; Investigators; Innovation; Approach; Environment; and Center Integration.   

    In the Research Strategy, applicants should clearly describe the problem(s) being addressed by the project and provide a timeline for project completion. The problem(s) being solved could be a discreet but critical gap in the larger context of a complex issue, or it may address a discrete question that, if left unanswered, would create an impediment to effectively protecting public health. The applicant should explain how the project advances knowledge or provides resources/technologies that could be utilized to improve human health, risk assessment, or improve the quality of the environment; and how the project provides rigorous scientific data that might be used for effective decision-making by stakeholders.

    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 by risk assessors and remediation managers at Superfund sites. This may also include addressing 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.

    In addition, there is an expectation that interdisciplinary teams have considered multiple vantage points in devising their research approach, by showing evidence of cross-talk between health, environmental, and exposure research expertise. SRP supports basic to applied research; however, it is important that each project - irrespective of whether it is basic or applied - frames the relevance of the study in the context of SRP’s four mandates. For example, BMR projects should demonstrate that the hazardous substance (and potential metabolites), its dose, exposure pathway, and model organism(s) are considered within the context of timing, prevalence, and detection of exposure and recalcitrance/resilience to remediation. They should justify their testing approaches as an appropriate model for the exposure-disease paradigm under investigation. They should also consider whether the chemical species/form or dose applied accounts for adsorption, distribution, metabolism, and elimination properties. Population studies should justify size, sex/gender, age, demographic group, etc. Project leaders should also clarify the degree to which an experimental study can be generalizable to other exposure scenarios. For ESE studies, the following should be considered: whether the hazardous substances under investigation are found in forms that are toxic and prevalent in the modeled exposure pathways; whether there is evidence that humans are being exposed; whether the media being monitored/remediated is relevant to the exposure pathway for a hazardous substance; whether the concentration levels measured/remediated are relevant to doses of concern (e.g. MCLs, LD50s, etc.); and whether the byproducts of a remediation process are less toxic than the parent compounds; etc. It is anticipated that some projects may be in the early stages of investigation; hence, researchers should articulate how their study may be used as a first step toward understanding unknowns related to an exposure pathway. Note: At least one ESE project must support the SRP mandate “basic biological, chemical, and physical methods to reduce the amount and toxicity of hazardous substances.”

    The expertise of the investigative team should be described (without duplicating information in the biosketches), including records of accomplishments that have advanced their field(s), mentorship for early-stage investigators (as appropriate) and how the organizational structure will help achieve the goals of the project. Innovative aspects of the project should be highlighted including whether the project challenges current research paradigms by utilizing novel theoretical concepts, approaches, methodologies, instrumentation, or interventions. This would include, but not be limited to, research aims that may be considered high risk, high reward research. For any high risk/high reward aims, applicants should provide preliminary data to demonstrate the feasibility of the approaches (methodology, tools, techniques, etc.). Applicants should describe how their proposed methodology and analyses are appropriate to accomplish the specific aims of the project as well as alternative strategies, and benchmarks for success. For projects in the early stages of development, applicants should describe how the research strategy establishes feasibility and manages risky aims. Applicants should describe how the research facility/institution supports the goals of the project, including equipment, physical resources, and other features that facilitate collaborative and multidisciplinary/interdisciplinary research approaches.

    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; 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 its 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 management plan should address methods of building and sustaining community partnerships and community participation including plans for lines of communication in challenging situations, such as disaster or other emergency). Include community engagement activities with the project timeline to provide a tentative sequence for the community engagement aspects of the research. For projects that involve research on hazardous waste sites, applicants should identify a plan involving the appropriate Federal, State, or Tribal agency, including a process and timeline for reporting results.

    Relation to Overall Center: Applicants should include a description that clearly states 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. Coordination and or shared specific aims should be cross-referenced between projects/cores. Interactions with the Administrative Core’s research translation functions and interactions with the Data Management and Analysis Core should also be included. Applicants may refer to their "Table of Integration with Center" attachment (see Overall Section "Other Attachments").

    Renewal Applications: For renewal applications, progress Reports should be included in the individual research projects under the “Approach” section of the Research Strategy. These should include a summary of activities carried out during the preceding performance period.   

    Letters of Support: Applicants may include letters to demonstrate the support of, for example, research collaborators, stakeholders, potential end-users, community stakeholders (if applicable), institutional support (if applicable), and/or entities whose resources may be utilized as part of research project (e.g. sample sharing, access to field site, etc.). See SF424 for details.:

    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 including a 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genomic Data Sharing Plan.

    The Data Sharing Plan should include a “Project-Specific Data Management Plan” and an “Investigator-Initiated Research Translation Plan.”

    • ·    The Project-Specific Data Management Plan should provide details about the project’s protocols and plans for data management, analysis, and sharing. Roles and responsibilities of the Project (versus Data Management and Analysis Core (DMAC)/other Cores/Projects) for achieving NIH-required data sharing requirements / other data activities should be clearly indicated. This section should be consistent with data-related activities described in the DMAC and/or respective Project/Cores (as appropriate). This section may cross-reference other sections of the application where details are provided (e.g. sections of the DMAC component, or other Project/Core Resource Sharing Plans).  
    • ·    The Investigator-Initiated Research Translation (IIRT) plan should be cross-referenced in the Administrative Core’s research translation functions.

    A description/checklist of a Project-Specific Data Management Plan and examples of Investigator Initiated Research Translation activities are provided for reference in the “Suggested Research and Activities” document on the following website (https://www.niehs.nih.gov/research/supported/centers/srp/funding/rfa/).

    Authentication of Key Biological and/or Chemical Resources: As applicable, applicants should describe methods to ensure the identity and validity of resources involved in the study, the authenticity of materials/chemicals used in the application, and methods to assure adequate standards/replicates. This section should be included for any projects working with biological or chemical substances. Applicants may wish to include other aspects of quality assurance and quality control (QA/QC) procedures including, but not limited to: a brief description of existing QA/QC procedures (e.g. at the research institution(s) and/or within the laboratory, etc.) including how staff will be trained to implement quality assurance, and who will be responsible for training; a brief description of calibration procedures and performance evaluation of key analytical instrumentation; references to standard methods (e.g. EPA, National Institute of Standards and Technology (NIST), etc.) utilized as part of the study; 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.

    Biohazards: As applicable, procedures for proper handling and disposal should be included for biological materials, hazardous chemicals/materials, etc. This section should be included for any projects working with hazardous substances.

    Appendix:

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

    PHS Human Subjects and Clinical Trials Information (Research Project)

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

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

    Study Record: PHS Human Subjects and Clinical Trials Information

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

    Delayed Onset Study

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

    Administrative Core

    When preparing your application, 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.

    Project Summary/Abstract: Include a Core Summary/Abstract that briefly describes how the Administrative Core will lead the Center and ensure that the Center’s projects and cores are being supported to achieve the Center’s goals. The summary should also include specific activities and innovative plans for supporting research translation of the projects and cores within the Center. 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 Center’s activities to public health, SRP stakeholders, Superfund, and the Superfund Research Program. 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 stakeholders (e.g., the agencies responsible for management of sites impacted by hazardous substances, as well as the individuals and communities impacted by these sites). 

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

    List all performance sites that apply to the specific component.

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

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

    • ·    In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Project Lead’ and provide a valid eRA Commons ID in the Credential field.
    • ·    In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
    • ·    A Senior/Key person should be named as a Research Translation Coordinator who will oversee the research translation efforts of the Center. This person should have the appropriate background to effectively work within their Center to translate research and effectively work with scientific and public health experts.
    • ·    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, but is not required, 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. Also, the Administrative Core should identify the individual(s) responsible for entering trainee (graduate and postdoctoral) data into the NIH CareerTrac database (

    https://careertrac.niehs.nih.gov/public/home

    ), as well as the individual(s) responsible for entering data into the SRP Data Collection Tool (http://tools.niehs.nih.gov/srp/resources/rtc.cfm.)

    Budget (Administrative Core)

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

    Annual SRP Grantee Meetings: Funds for travel by required staff (i.e., Center Director, Center Administrator, RETCC leader, Research Translation leader, Community Engagement Core leader, Data Management and Analysis Core leader, and at least four trainees) to attend the Superfund Research Program three-day annual meeting shall be included in the Administrative Core’s budget for each year. 

    Salary for individuals responsible for CareerTrac and Data Collection Tool entry may be included in the Administrative Core budget, if not already included in other project/core budgets.

    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 $150,000 Direct Costs for both new and renewal applications. Note: The sum of Direct Costs for the Administrative, Community Engagement, and Research Experience and Training Coordination 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, how it will integrate the Center, and how it will conduct research translation. A description should be provided for a plan for the following research translation objectives: 1) Communicating within SRP and to SRP staff; 2) Partnerships with Government Agencies; 3) Technology Transfer, 4) Information Dissemination to Other End-Users.   

    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 addressing 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 and integration among all the projects and cores and research translation. 

    The Administrative Core's Research Strategy should also demonstrate how the core will achieve its administrative functions of leadership, integration, and research translation. The applicant should designate a Research Translation Coordinator to achieve the research translation goals (provided below). As part of the leadership function, the Administrative Core must include a description of the lines of communication among the Center Administrator, Research Translation Coordinator, and other Center project and core leaders. Applicants should include 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 functions; coordinating data sharing and integration activities; the integration of cross-disciplinary research; overseeing of fiscal and resource management; and providing quality management. In addition, the Administrative Core is also responsible for ensuring that updates are made to the SRP Data Collection Tool (https://tools.niehs.nih.gov/srp/rtc/index.cfm) and to the NIH CareerTrac database (https://careertrac.niehs.nih.gov/auth/login) and should designate points of contact responsible for reporting this information, as well as a plan for frequency of reporting. The Core should describe a strategy for personnel management changes. This section should indicate who will be responsible for each of these activities and should describe the role(s) of advisory groups and consultants.

    External Advisory Committee. To aid the Director in achieving the goals set forth the 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 data sharing and integration activities in linking projects within the Center
    • ·    the effectiveness of research translation functions 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

    The composition of the EAC should reflect the goals of the Center and should include appropriate scientific expertise and appropriate stakeholders, which may include 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 provided input into the design of the application.

    Research Translation. The research strategy should also describe how the Administrative Core will achieve the following objectives to support effective research translation: 1) Communicating within SRP and to SRP staff; 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 the SRP: NIEHS requires the Administrative Core to appoint a Research Translation Coordinator who will communicate both within its institutional Center, as well as the greater SRP network (e.g. other SRP Centers, grantees, and SRP staff at NIEHS). Therefore, there is an expectation to serve in several key communication roles such as:

    a) Providing assistance in developing investigator-initiated research translation (IIRT) plans: The Research Translation Coordinator will work with each project to identify research translation opportunities for their IIRT plan, which is detailed in each projects’ "Resource Sharing Plan" (see Project “Resource Sharing Plan” section 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. For example, the SRP Data Collection Tool (DCT) 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.) Therefore, the RT Coordinator should ensure that project/core activities are reported to the DCT.

    c) Cross-Center communication: communicating with research translation coordinators from other SRP Centers. For example, the RT Coordinator should participate in regular SRP-hosted conference calls/webinars on research translation, and community engagement.

    Applicants are expected to delineate a plan and timeline for coordinating activities at all three levels listed above.

    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 the SRP. In addition, agencies such as the National Oceanic and Atmospheric Administration (https://www.noaa.gov , U.S. Geological Survey (https://www.usgs.gov), U.S. Department of Defense (https://www.defense.gov), and the U.S. Department of Energy (https://www.energy.gov) are important stakeholders and/or end-users of research and technology to manage and mitigate sites impacted by hazardous substances. It is important that in the Administrative Core 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. Administrative Core leaders and their Research Translation Coordinators may accomplish technology transfer through 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.

    4) Information Dissemination to Other End-users: Another important Administrative Core 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. The SRP therefore requires a plan to share 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 research translation 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). Note: The research translation function is meant to serve as a conduit to move project outcomes to end-users and is not meant to be a pilot project/activity program. 

    For all research translation activities, best communication practices must be utilized. As a reference, please see the NIH website on plain language: https://grants.nih.gov/grants/plain_language.htm.  Use of internet-assisted communication activities is particularly encouraged to accommodate stakeholders in remote locations or with limited travel options. Administrative Cores should also describe how their research translation functions are relevant to Superfund and the Superfund Research Program.

    Note: For survey activities that are considered human subjects research, applicants should describe their protocols in the "PHS Human Subjects and Clinical Trials Information" section of the application. Incentives for participants, if appropriate, should be detailed in the budget justification.

    Relation to Overall Center: 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. Lines of authority and interactions with the Center Administrator; Data Management and Analysis Core Leader; and Research Translation Coordinator should also be included.

    Renewal Applications: Renewal applications must include, in the Research Strategy, a progress report that describes achievements of the Administrative Core. This is also the section where the Center's research translation achievements since the last competitive review should be reported.

    Letters of Support: Applicants may include letters to demonstrate the support of, for example, research collaborators, stakeholders, potential end-users, community stakeholders (if applicable), institutional support (if applicable), and/or entities whose resources may be utilized as part of the Administrative Core (e.g. sample sharing, access to field site, etc.). Letters from stakeholders engaging in research translation activities are strongly encouraged. See SF424 for details.

    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, including a 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genomic Data Sharing Plan. The Data Sharing Plan should include a Core-Specific Data Management Plan to describe details about the core’s protocols and plans for data management, analysis, and sharing (as applicable). Roles and responsibilities of the Admin Core (versus Data Management and Analysis Core (DMAC)/other Cores/Projects) for achieving NIH-required data sharing requirements / other data activities should be clearly indicated. This section may cross-reference other sections of the application where details are provided (e.g. Investigator-Initiated Research Translation (IIRT) plans for respective Projects/Cores and the DMAC Research Strategy or Project/Core Resource Sharing Plans).

    Authentication of Key Biological and/or Chemical Resources: As applicable, applicants should describe methods to ensure the identity and validity of resources involved in the study, the authenticity of materials/chemicals used in the application, and methods to assure adequate standards/replicates. This section should be included for any cores working with biological or chemical substances. Applicants may cross-reference other sections of this component (e.g. “Research Strategy”) or other Project/Core components for additional details on authentication, quality assurance and quality control (QA/QC) procedures, if applicable to this core.

    Biohazards:  As applicable, procedures for proper handling and disposal should be included for biological materials, hazardous chemicals/materials, etc. This section should be included for any cores working with hazardous substances.

    Appendix:

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

    PHS Human Subjects and Clinical Trials Information (Administrative Core)

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

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

    Study Record: PHS Human Subjects and Clinical Trials Information

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

    Delayed Onset Study

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

    Data Management and Analysis Core

    When preparing your application, 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 (Data Management and Analysis 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 (Data Management and Analysis Core)

    Enter Human Embryonic Stem Cells in each relevant component.

    Research & Related Other Project Information (Data Management and Analysis 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 Summary/Abstract that briefly describes how the DMAC will support the management and integration of data assets across the Center.

    Project Narrative: It should be clear in the "Project Narrative" (i.e., the "public health relevance" statement) the relevance of the Core’s activities to public health, SRP stakeholders, Superfund, and the Superfund Research Program. 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 stakeholders (e.g., the agencies responsible for management of sites impacted by hazardous substances, as well as the individuals and communities impacted by these sites).

    Project /Performance Site Location(s) (Data Management and Analysis Core)

    List all performance sites that apply to the specific component.

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

    Research & Related Senior/Key Person Profile (Data Management and Analysis Core)

    • ·    In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Project Lead’ and provide a valid eRA Commons ID in the Credential field.
    • ·    In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
    • ·    The DMAC leader should have relevant experience to lead the data management and analysis core. The core key personnel should have expertise in data management; and, as applicable, may wish to include other expertise relevant to the DMAC's objectives (e.g., biostatistics and/or bioinformatics, and data visualization, information and knowledge management, software development, semantic engineering, etc.). 
    • ·    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 (Data Management and Analysis Core)

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

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

    PHS 398 Research Plan (Data Management and Analysis Core)

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

    Specific Aims: Specific Aims should describe the specific objectives and goals of the DMAC to support effective data management and analysis through development for all Center components.  Specific aims should be developed in the context of a comprehensive data management plan including: 1) coordination with projects and cores; 2) fostering data sharing and interoperability; and 3) data quality assurance and quality control. The specific aims section should also contain a brief statement about how the Core integrates with each of research projects and cores and helps to achieve the Center's goals.    

    Research Strategy: The Research Strategy should describe a Comprehensive Data Management Plan describing how the Core will serve as a resource for facilitating and supporting effective data management and analysis across the Center. For the purposes of this FOA, the DMAC would manage data generated from the Center's research projects and cores. The data would not be limited to "big data" (e.g., '-omics' or geographic information data) but would also include smaller datasets that may have a higher impact if made available for sharing. In addition, this section should include a description of the facilities, techniques, and professional skills/expertise provided by the core.

    The Comprehensive Data Management Plan should include the following: 1) coordination with projects and cores; 2) fostering data sharing and interoperability; 3) data quality assurance and quality control. It is anticipated that this plan would evolve to incorporate new data and any changes in data management policies/practices.

    1) Coordination with Projects and Cores. The DMAC should work closely with project/core leaders to support effective data management and analysis and assist with the development and refinement of individual project/core data management plans (see “Resource Sharing” section of project/core component). DMACs should also include a description of the types of data expected to be generated by the Center's projects/cores. The DMAC would work with project and core leaders in establishing a process for identifying which datasets hold a high priority for sharing versus data that may be more practical for internal curation (e.g., preliminary results from projects, etc.). The DMAC should assist project/core leaders in identifying appropriate data sharing platforms or strategies for sharing of prioritized data sets. This may include plans for how and in which form data will be shared (e.g. raw vs processed, de-identified) within and outside Center, and appropriate timelines for dataset deposition.  It is anticipated that data-rich projects/cores (e.g. -omics, mass spec, epidemiological research) may already have robust data management protocols within their projects/cores. In these cases, the DMAC may incorporate project/core protocols as part of the DMAC’s function. The DMAC should also indicate how it will support the data analytic, integration, and sharing efforts of each research project/core and how these interactions will occur over the course of the research projects/cores (e.g., monthly meetings with research project and core leaders). The DMAC may consider how it can encourage project/core leaders and trainees to analyze shared datasets, creating opportunities for exploring new linkages between data and the formation of new hypotheses. DMACs may also wish to develop a data management template (i.e., develop draft data management plan DMP for the project/core leads) to assist in organizing data assets with the projects/cores. The DMAC may indicate how it will coordinate with each research project/core leader on protection of intellectual property; assurance of and measures (steps taken) for data integrity and quality control; handling of sensitive and restricted data (e.g., human population studies) reporting of statistical analysis; timing for uploading data; and determining the most appropriate associated scientific discipline-endorsed vocabularies (i.e., ontologies). To facilitate these activities the core may wish to create a data management resource (e.g., a laboratory management information system) to capture these on-going interactions. The DMAC is highly encouraged to incorporate the concepts of "Findable, Accessible, Interoperable, and Reusable" (FAIR) as a guiding principle, when working with project/core leaders (Wilkinson MD et al. Sci Data. 2016; 3:160018)). Plans for training and education on data management and analysis practices may also be included. The DMAC should also designate a point of contact to inform SRP staff of dataset deposition through the optional SRP Data Collection Tool (in collaboration with the Center's Administrative Core) for when data is deposited.

    Additional Functionalities: In addition to the responsibilities outlined above, the DMAC may also include additional functionalities to assist projects/cores to advance the goals of data management and analysis. These additional functionalities may include, but would not be limited to: biostatistics, bioinformatics, machine learning, geographical information systems, data visualization, and computational modeling, etc. These additional functionalities would be optional and should not detract from the data management and analysis responsibilities of the DMAC.   

    2) Fostering Data Sharing and Interoperability. The research strategy should address plans for sharing data within and outside the Center, including which data repositories will be used. The DMAC should include discussion of ontology, data structures, standards, data platforms, interfaces, tools, and any data visualization approaches that may be used to facilitate data sharing and integration within the Center. While it is not expected for the DMAC to create a repository for the Center's data, the core should be familiar with databases that can be used to deposit the data (https://fairsharing.org/) and should develop a plan for project and core members to have access and use the data generated from the Center, with appropriate ethical controls in place. Also, the DMAC should provide a plan for interfacing with any larger institutional information technology infrastructure(s) and addressing requirements for database structures and security. In addition, the DMAC may describe how metadata (e.g., data descriptors) and ontologies (or semantic relationships) will be used to harmonize data across the Center to enable interoperability and compatibility and to identify the relationships between data. The DMAC should use common protocols where feasible and should capture experimental conditions (i.e., standardized data documentation) and analysis tools (e.g., codes and scripts). As applicable, the DMAC should highlight how the core activities enhance integration between BMR and ESE projects. The DMAC may look for data coordination and sharing opportunities within the SRP grantee community (e.g., shared virtual platforms, data commons) and should plan to participate in the SRP research translation/community engagement/data management and analysis core conference calls, as appropriate.

    3) Data Quality Assurance and Quality Control: The Research Strategy section should include a "Data Quality Assurance and Quality Control" statement that is applicable to the data types generated by the Center. This section should outline the Center's policy on implementing and assessing the effectiveness of its operations (for an example, see DataONE, https://www.dataone.org/best-practices/develop-quality-assurance-and-quality-control-plan) and include:

    • ·    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.
    • ·    A brief description of data quality assurance and control procedures.
    • ·    How a project/core staff and trainees will be trained to implement quality assurance, and who will be responsible for training.

    Relation to Overall Center: The DMAC 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 Administrative Core’s research translation functions should also be included. As applicable, applicants may cross-reference the "Summary of Center Data Management and Analysis" (see Resource Sharing Plan of the Overall Component) as well as the Data Management Plan for each project and core (see Resource Sharing Plan for Projects and Cores). A point of contact should be indicated in the Research Strategy section for the regular SRP data management and analysis core conference calls.

    Renewal Applications: Note: For renewal applications, previous FOAs did not have a Data Management and Analysis Core (DMAC) requirement; however, if a Center had a Research Support Core with data management and analysis facilities (and other DMAC-related functionalities) previously, it is permissible to include, as part of the DMAC Research Strategy, a summary of activities carried out during the preceding performance period, including information on core utilization by the individual Projects and/or Cores. For renewal applicants without previous DMAC functions or facilities, this section is not applicable. 

    Letters of Support: Applicants may include letters to demonstrate the support of, for example, research collaborators, stakeholders, potential end-users, community stakeholders (if applicable), institutional support (if applicable), and/or entities whose resources may be utilized as part of the DMAC (e.g. sample sharing, access to field site, etc.). Letters from data repository facilities and institutional support (if applicable), when leveraging such resources for the DMAC, are strongly encouraged. See SF424 for details.

    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 including a 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genomic Data Sharing Plan. Roles and responsibilities of the DMAC (versus other Cores/Projects) for achieving NIH-required data sharing requirements / other data activities should be clearly indicated. This section may cross-reference other sections of the application where details are provided (e.g. DMAC Research Strategy or Project/Core Resource Sharing Plans).

    Authentication of Key Biological and/or Chemical Resources: As applicable, applicants should describe methods to ensure the identity and validity resources involved in the study, the authenticity of materials/chemicals used in the application, and methods to assure adequate standards/replicates. This section should be included for any cores working with biological or chemical substances. Applicants may cross-reference other sections of this component (e.g. “Research Strategy”) or other Project/Core components for additional details on authentication, quality assurance and quality control (QA/QC) procedures, if applicable to this core.

    Biohazards: As applicable, procedures for proper handling and disposal should be included for biological materials, hazardous chemicals/materials, etc. This section should be included for any cores working with hazardous substances.

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

    PHS Human Subjects and Clinical Trials Information (Data Management and Analysis Core)

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

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

    Study Record: PHS Human Subjects and Clinical Trials Information

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

    Delayed Onset Study

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

    Community Engagement Core

    When preparing your application, use Component Type ‘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 (CEC) will support the Center. The summary should not be a general description of the requirements of the CEC. Rather, 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.  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 that complement the Center's research. The prevention/intervention activity/activities should support SRP's fourth mandate which includes "basic biological, chemical, and physical methods to reduce the amount and toxicity of hazardous substances." 

    Project Narrative: It should be clear in the "Project Narrative" (i.e., the "public health relevance" statement) the relevance of the Core's activities to public health, SRP stakeholders, Superfund, and the Superfund Research Program. 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 stakeholders (e.g., the agencies responsible for management of sites impacted by hazardous substances, as well as the individuals and communities impacted by these sites).

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

    List all performance sites that apply to the specific component.

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

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

    • ·    In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Project Lead’ and provide a valid eRA Commons ID in the Credential field.
    • ·    The CEC leader/staff should have appropriate expertise to conduct community engagement activities and work with communities affected by hazardous substances.
    • ·    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 CEC annual budget must not exceed $100,000 Direct Costs. Note: the sum of Direct Costs for the Administrative, Community Engagement, and Research Experience and Training Coordination 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 (Community Engagement Core)

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

    Specific Aims: The specific aims indicate which community or communities are planned for partnerships, as well as which hazardous substances are impacting the community or communities.  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 that complement the Center's research. The prevention/intervention activity/activities should support SRP's fourth mandate which includes "basic biological, chemical, and physical methods to reduce the amount and toxicity of hazardous substances." The specific aims section should also contain a brief statement about how the Core integrates with the rest of the Center. As applicable, applicants should denote aims that are collaborative/shared between other projects/cores.   

    Research Strategy: The CEC should propose intervention and prevention activities with members of affected communities. For the purposes of this FOA and to be consistent with its mandates, the SRP refers to prevention/intervention as "basic biological, chemical, and physical methods to reduce the amount and toxicity of hazardous substances." The 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. In addition, the CEC is encouraged to develop projects with environmental justice (EJ) communities i.e., economically disadvantaged, underserved or vulnerable populations, minority populations, and Tribal communities, as these groups are frequently impacted by hazardous substance exposures. (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, sex/gender, or residency status (permanent vs. transient).

    The CEC should be designed to fit within the theme of the Center. The CEC facilitates bidirectional exchange between Center scientists and the community with the overall intent to prevent and/or intervene to reduce exposure and protect human health, consistent with SRP’s fourth mandate.  A variety of appropriate CEC activities and resources have been listed in the "Suggested Research and Activities" document on the following website (https://www.niehs.nih.gov/research/supported/centers/srp/funding/rfa). Applicants should describe how CEC activities are relevant to Superfund and to the Superfund Research Program.

    In some cases, CECs may choose to, but are not required to, include biological or environmental sample collection as part of their core prevention and intervention activities. CECs proposing to collect biological or environmental samples should include details of sampling methodology, analysis, statistical calculations (e.g., power) to ensure best practices are being adopted and communities are receiving scientifically defensible data. (Note: if a CEC plans to collect biological samples, the CEC must indicate delayed onset human subject. If the samples are collected by another Project or Core, the CEC must reference the process from the Core or Project’s section of the application. For more information and the definition of delayed onset, please see https://grants.nih.gov/policy/clinical-trials.htm)

    In the Research Strategy, the CEC should include a timeline (not to overlap with Study Timeline (section 2.7) of the PHS Human Subjects and Clinical Trials Information Form, as applicable) for activities with milestones; a plan to measure and verify outcomes (e.g., a logic model); and a process to guarantee effective bidirectional exchange between the CEC and the community of their 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. Note: extensive sampling may be more appropriate for a Research Project rather than a Community Engagement Core activity.  

    Also, within the Research Strategy, the CEC should include descriptions of the following:

    • ·    A clearly defined community of interest or community partner and the community's/researchers' roles. 
    • ·    Prevention/intervention opportunities that are of clear interest/priority to the community and are a clear link to SRP’s fourth mandate: basic biological, chemical, and physical methods to reduce the amount and toxicity of hazardous substances.
    • ·    How the prevention/intervention activity will lead to an improved understanding of the research by the community and improved public health in the community.
    • ·    How the activity/activities will lead to bidirectional relationships between the academic institution and the community, and the benefit of the relationship to both.
    • ·    Evidence of the community's acceptance of the role as a partner in the core and that the community views their engagement an integral part of the core prevention/intervention activity (e.g., letters of support from the community can be attached in the Letters of Support section).
    • ·    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. 
    • ·    The approach and methodology for surveys and/or sample collection (e.g., biological monitoring, seafood/plant tissue, environmental media). Coordination with other projects/cores is encouraged to support these efforts; however, it is recommended that sufficient detail is provided within the CEC Research Strategy to give evidence that best practices are being followed and the appropriate expertise is being allocated to the activity.
    • ·    A management plan for maintaining transparent communications between the community and the academic partners throughout the entirety of an activity. The plan should address methods of building and sustaining community partnerships and community participation. It should also include plans for lines of communication in challenging situations (e.g. in the event of a disaster or other emergency).

    Note: Incentives for participants, if appropriate, should be detailed in the budget justification.

    Relation to Overall Center: The Research Strategy section of the CEC should include a "Relation to Overall Center" statement. In this statement, clearly state how the Core's prevention and intervention activities relate 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 Administrative Core's research translation functions should also be included. A point of contact should be indicated in the Research Strategy section for the regular SRP research translation/community engagement/data management and analysis core conference calls.

    Renewal Applications: Progress Reports should be included of the Research Strategy of the CEC. For renewals, summarize activities carried out during the preceding performance period.

    Letters of Support: Applicants may include letters to demonstrate the support of, for example, research collaborators, stakeholders, potential end-users, community stakeholders (if applicable), institutional support (if applicable), and/or entities whose resources may be utilized as part of the CEC (e.g. sample sharing, access to field site, etc.). Letters from community stakeholders are strongly encouraged.  See SF424 for details.

    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 including a 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genomic Data Sharing Plan. The Data Sharing Plan should include a Core-Specific Data Management Plan to describe details about the core’s protocols and plans for data management, analysis, and sharing (as applicable). Roles and responsibilities of the CEC (versus Data Management and Analysis Core (DMAC)/other Cores/Projects) for achieving NIH-required data sharing requirements / other data activities should be clearly indicated. This section may cross-reference other sections of the application where details are provided (e.g. DMAC Research Strategy or Project/Core Resource Sharing Plans).

    Authentication of Key Biological and/or Chemical Resources: As applicable, applicants should describe methods to ensure the identity and validity resources involved in the study, the authenticity of materials/chemicals used in the application, and methods to assure adequate standards/replicates. This section should be included for any cores working with biological or chemical substances. Applicants may cross-reference other sections of this component (e.g. “Research Strategy”) or other Project/Core components for additional details on authentication, quality assurance and quality control (QA/QC) procedures, if applicable to this core.

    Biohazards: As applicable, procedures for proper handling and disposal should be included for biological materials, hazardous chemicals/materials, etc. This section should be included for any cores working with hazardous substances.

    Appendix:

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

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

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

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

    Study Record: PHS Human Subjects and Clinical Trials Information

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

    Delayed Onset Study

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

    Research Experience and Training Coordination Core

    When preparing your application, 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 Experience and Training Coordination 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 Experience and Training Coordination Core)

    Enter Human Embryonic Stem Cells in each relevant component.

    Research & Related Other Project Information (Research Experience and Training Coordination 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: Provide an abstract of the Research Experience and Training Coordination Core (RETCC). Include the objectives, rationale, and design of the RETCC, as well as the key activities that will be conducted by the 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, post-doctoral), the duration of the proposed training, the projected number of participating trainees, and their anticipated levels of experience.

    Project Narrative: Provide a brief description of the public health impacts of this core, as applicable.

    Other Attachments:

    • ·    Trainee List (For renewal applications only). Renewal applications should provide a "Trainee List".  In the "Trainee List", it is important that the application identifies the graduate students and post-doctoral researchers who participated in the RETCC during the previous funding cycle. This list should be in tabular form and 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/public/home. An illustration of the "Trainee List" can be found here: https://www.niehs.nih.gov/research/supported/centers/srp/funding/rfa/rfa_tips/index.cfm

    Project /Performance Site Location(s) (Research Experience and Training Coordination Core)

    List all performance sites that apply to the specific component.

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

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

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

    Budget (Research Experience and Training Coordination Core)

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

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

    Given the limited core budget, compensation for trainees is expected to be provided through their respective project or core components rather than the RETCC. In addition, other related training costs (e.g., research equipment, supplies) should be part of the project or core budgets rather than the RETCC budget. 

    Activities that may be supported by the RETCC include cross-disciplinary laboratory experiences, invitational travel for speakers for Center seminar series for trainees, development of a journal club, trainee specific workshops related to professional development, and travel of trainees to scientific meetings. Provide details on level of effort and salary of core leader/staff, description other expenses, etc. in the justification section.

    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 Experience and Training Coordination 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 integrate with the rest of the Center.     

    Research Strategy: The Research Strategy of the RETCC should include how the core will: 1) promote and use interdisciplinary approaches to training; 2) promote trainees from diverse backgrounds to participate in RETCC activities and in the Center’s overall research program, projects, and cores; 3) provide trainees with opportunities to enhance their professional career development and mentoring of SRP and non-SRP trainees (e.g., undergraduates, high school students, elementary students, and trainees of diverse backgrounds); 4) coordinate opportunities for trainee participation in the Community Engagement Core and the Administrative Core's research translation functions; 5) interact with the Data Management and Analysis Core (DMAC) to provide training and education on data management and analysis practices and data sharing opportunities; and 6) provide information about the Center's activities and trainees to the SRP. Note: it is not mandatory for trainees to participate in Community Engagement Core and Administrative Core's research translation functions, but it is highly encouraged.

    The Research Strategy should include a description of the activities and training opportunities for the Center's trainees, which may include tailored curricula development, selected coursework to fulfill degree requirements, cross-disciplinary laboratory experiences, seminar series, journal clubs, workshops/conferences related to professional development, and travel to scientific meetings, etc.  The core should also provide a description of how the trainees' activities will be guided, and how the trainees' performance will be monitored and evaluated. These activities (and those described below) should be in coordination with Administrative Core and Project/Core leaders.

    The Research Strategy should also include a plan for recruiting potential Center trainees to the SRP KC Donnelly Externship Program (https://www.niehs.nih.gov/research/supported/centers/srp/training/donnelly/index.cfm), which has been established to provide current SRP-funded graduate students and postdoctoral researchers with translational/transdisciplinary opportunities and experiences within other SRP-funded grantees, government laboratories (EPA, ATSDR, NIEHS), or other agencies (state, local, Tribal). In addition, the RETCC should also include a plan for how it will recruit trainee applicants for the SRP Karen Wetterhahn Memorial Award (https://www.niehs.nih.gov/research/supported/centers/srp/training/wetterhahn/index.cfm), which was established as an annual award to recognize an outstanding graduate student or post-doctoral researcher that best demonstrates qualities of scientific excellence and leadership.  The core should also develop a plan to identify opportunities to recruit trainees from diverse backgrounds.  The RETCC description should also include a timeline with milestones of the Core's activities. The timeline should also indicate the frequency for trainee information submission/updates to the NIH CareerTrac database (https://careertrac.niehs.nih.gov/public/home). NIH CareerTrac database 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 to help NIH in overall coordination of its various research training programs. In addition, CareerTrac can also be used by a Center to conduct analyses and evaluate the effectiveness of their specific training program (e.g. reporting in Research Performance Progress Reports).  All graduate students and postdoctorates conducting research/activities supported by the Center are considered SRP Trainees and should be entered into the NIH CareerTrac. Applicants should identify the point of contact for entering data into the NIH CareerTrac database. The same point of contact should also be listed in the Administrative Core.  The RETCC should also provide points of contact for regular SRP-hosted Student/Post-Doc/Alumni Network (SPAN) Leadership Committee conference calls/webinars (e.g., RETCC Leaders and representative graduate students and Post-Docs from the Center; see: https://www.niehs.nih.gov/research/supported/centers/srp/training/spa/committee/index.cfm). 

    Relation to Overall Center: The RETCC should also include a "Relation to Overall Center" statement within the Research Strategy. 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.

    Note: Recommended RETCC activities have been listed in the "Suggested Research and Activities" document (see: https://www.niehs.nih.gov/research/supported/centers/srp/funding/rfa/).

    Renewal Applications: Progress Reports for the Training Core should be included in the Research Strategy of the RETCC. For renewals, summarize activities carried out during the preceding performance period.

    Letters of Support: Applicants may include letters to demonstrate the support of, for example, research collaborators, stakeholders, potential end-users, community stakeholders (if applicable), institutional support (if applicable), and/or entities whose resources may be utilized as part of the RETCC (e.g. sample sharing, access to field site, etc.). See SF424 for details.

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

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

    PHS Human Subjects and Clinical Trials Information (Research Experience and Training Coordination Core)

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

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

    Study Record: PHS Human Subjects and Clinical Trials Information

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

    Delayed Onset Study

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

    Research Support Cores

    When preparing your application, 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 (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 Center's activities to public health, SRP stakeholders, Superfund, and the Superfund Research Program. 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 stakeholders (e.g., the agencies responsible for management of sites impacted by hazardous substances, as well as the individuals and communities impacted by these sites). 

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

    List all performance sites that apply to the specific component.

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

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

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

    Budget (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.

    PHS 398 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 and Data Management and Analysis Core Utilization," described in the Overall component). A Research Support Core is principally designed as a service or resource component; it would be highly unusual to include research in a Research Support 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 the Core's 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. Discuss ways in which the Core augments interdisciplinary activities and/or integration between projects and cores.

    In the Research Strategy section, Research Support Cores that provide analytical and quantitative services to the applicant's Center should include a Quality Assurance Section. The Quality Assurance Section should document a Center's policy on implementing and assessing the effectiveness of its quality assurance and quality control operations. General guidance can be found at https://www.epa.gov/quality.

    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 (e.g., data/statistical analysis methods and references to software) and plans for coordinating with Project(s)/DMAC.
    • ·    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) and coordinated with Project(s)/DMAC (note, applicants may wish to cross-reference the Research Support Core’s “Resource Sharing Plan” for additional details).

    Relation to Overall Center: 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 Data Management and Analysis Core should also be included. It is recommended to reference the "Table of Research Support and Data Management and Analysis Core Utilization" (Overall Section) which includes the percentage use of the core relative to the individual projects.

    Renewal Applications: For renewals, in the Research Strategy Section, summarize activities carried out during the preceding performance period. Include core utilization by the individual Research Projects. 

    Letters of Support: Applicants may include letters to demonstrate the support of, for example, research collaborators, stakeholders, potential end-users, community stakeholders (if applicable), institutional support (if applicable), and/or entities whose resources may be utilized as part of the Research Support Core (e.g. sample sharing, access to field site, etc.). See SF424 for details.

    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 including a 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genomic Data Sharing Plan. The Data Sharing Plan should include a Core-Specific Data Management Plan to describe details about the core’s protocols and plans for data management, analysis, and sharing. Roles and responsibilities of the Research Support Core (versus Data Management and Analysis Core (DMAC)/other Cores/Projects) for achieving NIH-required data sharing requirements / other data activities should be clearly indicated. This section should be consistent with data-related activities described in the DMAC and/or respective Projects/Cores. This section may cross-reference other sections of the application where details are provided (e.g. sections of the DMAC component, or other Project/Core Resource Sharing Plans). Research Support Cores may also provide plans for research translation as part of the Data Sharing Plan (optional).

    Authentication of Key Biological and/or Chemical Resources: As applicable, applicants should describe methods to ensure the identity and validity resources involved in the study, the authenticity of materials/chemicals used in the application, and methods to assure adequate standards/replicates. This section should be included for any cores working with biological or chemical substances. Applicants may cross-reference other sections of the Research Support Core component (e.g. “Research Strategy”) or other Project/Core components for additional details on authentication, quality assurance and quality control (QA/QC) procedures, if applicable to this core.

    Biohazards: As applicable, procedures for proper handling and disposal should be included for biological materials, hazardous chemicals/materials, etc. This section should be included for any cores working with hazardous substances.

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

    PHS Human Subjects and Clinical Trials Information (Research Support Core)

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

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

    Study Record: PHS Human Subjects and Clinical Trials Information

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

    Delayed Onset Study

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

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

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

    4. Submission Dates and Times

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

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

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

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

    5. Intergovernmental Review (E.O. 12372)

    This initiative is not subject to intergovernmental review.

    6. Funding Restrictions

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

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

    7. Other Submission Requirements and Information

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

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

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

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

    Important reminders:

    All PD(s)/PI(s) and component Project Leads must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

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

    See more tips for avoiding common errors.

    Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by the National Institute of Environmental Health Sciences, NIH. Applications lacking clear relevance to SRP and Superfund will be considered nonresponsive. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

    Funding Opportunity Webinar

    In October 1, 2020, from 1:30 - 2:30 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: https://www.niehs.nih.gov/research/supported/centers/srp/funding/rfa/index.cfm.

    Post Submission Materials

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

    Section V. Application Review Information
    1. Criteria

    Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

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

    Overall Impact - Overall

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

    Scored Review Criteria - Overall

    Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a Center that by its nature is not innovative may be essential to advance a field.

    Significance

    Does the Center address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous?  If the aims of the 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? 

    For this particular announcement, note the following: Does the Center address important gaps in our knowledge of human health effects, risks, detection, and mitigation of hazardous substances in the environment?  

    If successful, would the Center provide data, information, and knowledge to inform the risk assessment and remediation management processes? If successful, would the 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?

    In addition, for applications involving clinical trials:

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

    Investigator(s)

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

    For this particular announcement, note the following: 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? Is there evidence the Center enhances the professional pipeline and diversity in environmental health sciences? 

    In addition, for applications involving clinical trials

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

    Innovation

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

    For this particular announcement, note the following: Does the Center propose an innovative solution to critical barriers in the understanding of the physical, chemical, and biological properties of hazardous substances in the environment?

    In addition, for applications involving clinical trials

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

    Approach

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

    If the 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 individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?   

    For this particular announcement, note the following: Would the expected achievements of the Center be possible through approaches other than this multi-project Center? Does the Center propose a properly devised strategy for tackling their central research problem? 

    In addition, for applications involving clinical trials

    Does the application adequately address the following, if applicable:

    Study Design

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

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

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

    Data Management and Statistical Analysis

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

    Environment

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

    For this particular announcement, note the following: Is there evidence of interdepartmental cooperation needed to carry out the multi-disciplinary activities of the Center?

    In addition, for applications involving clinical trials

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

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

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

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

    Additional Review Criteria - Overall

    As applicable for the 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.

    Integration of the Center

    Does the Center propose to integrate projects and cores to target problem(s) within the 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 research with the environmental science and engineering research as it contributes to the accomplishment of Center goals? Is there evidence of integration of the Administrative, Data Management and Analysis, Community Engagement and Research Experience and Training Coordination Cores with the Research Projects (and Research Support Cores, if applicable)? Is there evidence that data management/sharing activities will provide integration opportunities between projects and cores and enhance the impact of the Center’s research and activities? 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 to achieve meaningful contributions to protecting human health and the environment?

    Study Timeline

    Specific to applications involving clinical trials

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

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

    Protections for Human Subjects

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

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

    Inclusion of Women, Minorities, and Individuals Across the Lifespan  

    When the proposed 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 individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed.  For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

    Vertebrate Animals

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

    Biohazards

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

    Resubmissions

    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.

    Revisions

    Not Applicable

    Additional Review Considerations - Overall

    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.

    Applications from Foreign Organizations

    Not Applicable

    Select Agent Research

    Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

    Resource Sharing Plans

    Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genomic Data Sharing Plan  Is the Data Sharing Plan’s “Summary of Center Data Management and Analysis” reasonable?.


    Authentication of Key Biological and/or Chemical Resources

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

    Budget and Period of Support

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

    Overall Impact – Research Projects

    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).

    Review Criteria Specific to Research Projects

    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. 

    Significance (Research Projects)

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

    If the study is successful, would it lead to incremental advance, or would it provide a substantial step forward? 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? 

    In addition, for projects involving clinical trials:

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

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

    In addition, for projects involving clinical trials:

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

    Innovation (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?

    In addition, for projects involving clinical trials:

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

    Approach (Research Projects)

    Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the Center? Have investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed?  Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects? Does the chemical species/form or dose applied account for adsorption, distribution, metabolism, and elimination properties; and is it justified? For population studies, is there proper justification for size, sex/gender, age, demographic group, etc.? If an aim is high risk high reward, does the applicant provide adequate preliminary data to demonstrate the feasibility of the approaches (methodology, tools, techniques, etc.)?

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

    For each project, does the “Project-Specific Data Management Plan" adequately describe how research data will be managed, analyzed, and shared? For each project, does the “Investigator-Initiated Research Translation Plan" adequately describe how research translation of the project will be conducted?  Do the Project investigators have an adequate plan to work in conjunction with the Administrative Core's research translation functions to identify appropriate research translation opportunities? 

    If the Project  involves human subjects and/or NIH-defined clinical research, are the plans to address:

    1) the protection of human subjects from research risks, and

    2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?   

    In addition, for applications involving clinical trials:

    Does the application adequately address the following, if applicable:

    Study Design

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

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

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

    Data Management and Statistical Analysis

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

    Environment (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?

    In addition, for applications involving clinical trials

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

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

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

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

    Review Criteria Specific to Cores

    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 reflect the theme and interdisciplinary nature of the Center? Is there evidence that the lines of authority and structure are designed for effective management/leadership of the Center? Are the qualifications, duties, and time commitments of administrative staff (e.g., Center Director, Research Translation Coordinator, and Center Administrator) appropriate? Does the Center Director have appropriate experience and have they demonstrated effective and responsible leadership in the past? If applicable, is the role/expertise of the Deputy Director appropriate for the Administrative Core? Is there adequate evidence of: institutional commitment; plans to promote integration/coordination (particularly between biomedical and environmental science and engineering projects) including data analysis/integration/sharing; fiscal/resource/quality management oversight; and interactions between components and external partners/communities? Is the plan for reporting updates (e.g. SRP Data Collection Tool, NIH CareerTrac database) adequate? Is there an adequate plan to establish/utilize an external advisory committee (EAC)? Do EAC members have the expertise to evaluate all projects and cores and represent stakeholders? For new applications, are the appropriate areas of expertise identified for the proposed External Advisory Committee?

    Are the proposed activities for research translation adequate to achieve its objectives: communicating with the SRP, partnerships with government agencies, technology transfer, and information dissemination to other end-users adequate? Is there an adequate plan for coordinating with the CEC, RETCC, DMAC, and Research Support Cores (as applicable)? Does the Core promote and/or enhance interactions among the Center components and identify research translation opportunities on a per-project basis (e.g., investigator-initiated research translation)? Is there evidence of adequate commitment and support for the research translation activities? Are milestones delineated, realistic, and appropriate? As applicable, does the “Core-Specific Data Management Plan" adequately describe how research data will be managed, analyzed, and shared? 

    Review Criteria Specific to Data Management and Analysis Core

    Are the objectives of the Data Management and Analysis Core (DMAC) appropriate to the Center? Is the Center-wide Data Management Plan adequate and does it include plans for coordination with projects and cores; fostering data sharing and interoperability; and data quality assurance and quality control? Are the approaches, methods, and expertise, proposed adequate to achieve objectives? Does the DMAC adequately promote and/or enhance interactions among the Center components? Does the DMAC have an adequate and well-reasoned plan to prioritize datasets to be shared; to identify platforms for sharing; and to establish appropriate timelines for dataset deposition? Are the plans to support the data analytic, integration, and sharing efforts of projects and cores reasonable and adequate? For Centers proposing additional functionality within the DMAC (e.g., biostatistics, bioinformatics, machine learning, data visualization, GIS, etc.), is expertise adequate to support additional functionality? Does the additional functionality enhance or detract from the data management and analysis goals of the DMAC?

    Review Criteria Specific to Community Engagement Core

    Does the Core highlight appropriate prevention/intervention activities tailored to fit the goals of the Center and complement the Center's research?  Are the main Core activities clearly linked with SRP’s fourth mandate, “basic biological, chemical, and physical methods to reduce the amount and toxicity of hazardous substances”?  Is the community of interest clearly defined and are roles clearly described? Is there evidence of the community's acceptance as a partner and that the community is integral  to the proposed activities? Are the objectives of the core of high interest and beneficial to the community? Is there evidence of adequate bidirectional communication plan between the community and the academic partners throughout the entire process of the activity? Are the approach and methodology adequately described and appropriate according to community socioeconomic and cultural factors? Does the investigator demonstrate adequate experience to lead the core to ensure success for conducting the proposed community engagement activities?  Is appropriate expertise being allocated to activities (including survey/sampling, as applicable)?  Does the environment enhance the likelihood of success? As applicable, does the “Core-Specific Data Management Plan" adequately describe how research data will be managed, analyzed, and shared? 

    Review Criteria Specific to Research Experience and Training Coordination Core

    Are the objectives, design, activities, and direction of the RETCC appropriate to the Center and likely to ensure effective training and professional development for the Center's trainees? Does the RETCC provide adequate inter- or multidisciplinary research and training opportunities that are appropriate to the Center? Does the RETCC adequately promote trainees from diverse backgrounds to participate in RETCC activities and in the Center’s projects, and cores?  Is the level of institutional commitment  sufficient to ensure the success of the Center and its trainees?  Is there sufficient assurance that RETCC Leader and mentors (e.g., Project and Core Leaders) will be devoted directly to the research training, career development, and RETCC-related activities?  Does the RETCC Leader demonstrate experience to provide direction and management of the Core? Does the RETCC Leader encourage the trainees to participate in professional development and/or leadership opportunities?  Does the RETCC leader provide an adequate plan to coordinate with the Administrative Core including Research Translation) and Project/Core Leaders (including CEC and DMAC). Is there an adequate plan to promote participation in the SRP KC Donnelly Externship Program, SRP Karen Wetterhahn Memorial Award, and opportunities to promote diversity within the SRP  Center? Does the RETCC provide an adequate plan for communicating with SRP about the Center's trainees and provide an adequate evaluation plan to assess the quality and effectiveness of the training (e.g., use of NIEHS's CareerTrac database)?

    Review Criteria Specific to Research Support Core(s)

    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 (i.e. integration and/or interdisciplinary activities) 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, does the “Core-Specific Data Management Plan" adequately describe how research data will be managed, analyzed, and shared? 

    Additional Review Criteria – Research Projects and Cores

    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 (e.g., 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 (e.g., 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 categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

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

         Inclusion of Women, Minorities, and Individuals Across the Lifespan

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

         Vertebrate Animals

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

         Biohazards

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

         Resubmissions

    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. In addition, please note the following: 

    Administrative Core: For renewal applications, is there evidence that the Center has previously developed approaches for transferring research findings to appropriate audiences working in the field of hazardous waste management? Is there evidence that the transfer of research findings to these audiences has occurred? Did the applicant demonstrate effective communication with other SRP Centers and SRP staff and to broad and targeted audiences? 

    Research Experience and Training Coordination Core: For renewal applications, has the RETCC demonstrated commitment to tracking/reporting trainee accomplishments (e.g.  If the Center supports clinical trial research experience for the Trainees, do the mentor(s) who will supervise the trainee(s) have the expertise, experience, resources, and ability to provide appropriate guidance and help the trainee(s) to meet the timelines of the research?

    2. Review and Selection Process

    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 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.  
    3. Anticipated Announcement and Award Dates

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

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

    Section VI. Award Administration Information
    1. Award Notices

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

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

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

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

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

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

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

    2. Administrative and National Policy Requirements

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

    Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex.  This includes ensuring programs are accessible to persons with limited English proficiency.  The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS.  Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html.

    HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.  For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA.

    Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.    

    In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements.  FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award.  An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS.  The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 “Federal awarding agency review of risk posed by applicants.”  This provision will apply to all NIH grants and cooperative agreements except fellowships.

    Cooperative Agreement Terms and Conditions of Award

    Not Applicable

    3. Reporting

    When multiple years are involved, 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 RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

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

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

    Section VII. Agency Contacts

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

    Application Submission Contacts

    eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

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

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

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

    Scientific/Research Contact(s)

    Heather Henry, PhD
    National Institute of Environmental Health Sciences (NIEHS))
    Telephone: 984-287-3268
    Email: heather.henry@nih.gov

    Danielle Carlin, PhD, DABT
    National Institute of Environmental Health Sciences (NIEHS)
    Telephone: 984-287-3244
    Email: danielle.carlin@nih.gov

    Michelle Heacock, PhD
    National Institute of Environmental Health Sciences (NIEHS)
    Telephone: 984-287-3267
    Email: HeacockM@niehs.nih.gov

    William A. Suk, PhD, MPH
    National Institute of Environmental Health Sciences (NIEHS)
    Telephone: 984-287-3325
    Email: suk@niehs.nih.gov

    Brittany Trottier, MPH
    National Institute of Environmental Health Sciences (NIEHS)
    Telephone: 984-287-3331
    Email: brittany.trottier@nih.gov

    Peer Review Contact(s)

    Laura Thomas, PhD
    National Institute of Environmental Health Sciences (NIEHS)
    Telephone: 984.287.3328
    Email: laura.thomas@nih.gov

    Financial/Grants Management Contact(s)

    Jenny Greer, MA
    National Institute of Environmental Health Sciences (NIEHS)
    Telephone: 984.287.3332
    Email: jenny.greer@nih.gov

    Section VIII. Other Information

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

    Authority and Regulations

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

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