Part 1. Overview Information

Key Dates

All applications are due by 5:00 PM local time of applicant organization. 

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

No late applications will be accepted for this Notice of Funding Opportunity (NOFO).

It is critical that applicants follow the Multi-Project (M) Instructions in the How to Apply - Application Guide, except where instructed to do otherwise (in this NOFO or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the How to Apply - Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the How to Apply - Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the How to Apply - 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.

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

Research Objectives

The NIEHS invites qualified investigators from domestic institutions of higher education to submit an application for an SRP Center grant. SRP legislation, under SARA of 1986, allows NIEHS the flexibility to create university-based Centers to conduct research to address the wide array of scientific uncertainties facing the national Superfund program.  Per 42 USC 9660 (a)(3) eligible applicants are limited to accredited institutes of higher education. Please see Section III. Eligibility for additional information. In accordance with NIH standard peer-review processes, the application(s) will be peer-reviewed, and only meritorious application(s) will be considered for funding. The complex problems related to sites impacted by hazardous substances requires the expertise of both biomedical research (BMR) and environmental science and engineering (ESE) disciplines. Applicants responding to this Notice of Funding Opportunity Announcement (NOFO) are expected to design a research Center that integrates BMR (e.g., toxicology, epidemiology, mechanistic studies) with ESE (e.g., remediation, geosciences, ecological sciences). The goal of a 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.

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 BMR and ESE to advance scientific 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 improve public health. Centers are also expected to facilitate transfer of research findings through coordinated data management and analysis; engage communities, end-users, and stakeholders with prevention/intervention strategies to reduce exposures; share findings to broader audiences; and train the next generation of scientists. (SRP defines stakeholders as those individuals and entities that benefit from SRP research and technologies in improving public health.)

Problem-based, Solution-oriented Research: Applicants are expected to design Centers that will contribute to solving a scientific problem(s) related to SRP’s mandates and with relevance to Superfund. The problem being solved could be a discreet but critical gap in the larger context of a complex issue, or it may answer a specific question, that if left unanswered, would create an impediment to effectively protect public health.

Relevance to SRP Mandates and Superfund: Given SRP’s broad mandates, it is important for interdisciplinary teams to work together to foster research that addresses Superfund 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 these reasons, applicants should assemble teams that consider multiple vantage points 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 end-users as important criteria for determining relevance. SRP end-users include the Superfund programs at the U.S. Environmental Protection Agency (EPA) and Agency for Toxic Substances and Disease Registry (ATSDR). In addition, U.S. Geological Survey (USGS), U.S. Department of Defense (DOD), and the U.S. Department of Energy (DOE) are important end-users of research and technology to manage and mitigate sites impacted by hazardous substances. In addition, the National Science Foundation (NSF) and other NIH Institutes and Centers may provide valuable opportunities to promote and leverage the findings of SRP research.  The SRP also considers other federal, state, local, and Tribal governments, and communities impacted by hazardous substances as important end-users. Other stakeholders to be considered include formal/informal educational groups, hazardous waste practitioners, the general public, and other academic researchers.  Therefore, investigators should seek input from end-users mentioned above during application development and identify critical issues for which fundamental science is needed. 

(Note: Applications lacking clear relevance to SRP Mandates and Superfund will be considered nonresponsive.)

Center Structure

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

Administrative Core: an Administrative Core is required in each SRP Center grant application (which includes Center leadership, data management, and training functions):

• This Core provides leadership to the Center, maintains the organization of the Center, and ensures that the projects and cores are being supported to achieve the Center’s goals.
• To support the NIH data sharing policy, the Administrative Core and its Data Management Coordinator are tasked with leveraging institutional/computing infrastructure to support the management and integration of data assets across the Center.  They are expected to work closely with project/core leaders to ensure high data quality throughout the entire lifecycle of the data and identify opportunities for integrating project/core-generated data with other existing datasets, accelerating the impact of the Center's research.
• The Administrative Core should include a Training Coordinator to promote scientific workforce development and provide opportunities to enhance the Center's graduate and postdoctoral trainees multi-disciplinary research experiences and training. 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 biomedical research and vice versa for biomedical research-focused trainees. (Note: Per its mandates, the SRP defines "trainees" as graduate level training (e.g., Masters, PhD., Post doc).

Translational Research and Engagement Core: a Translational Research and Engagement Core (TREC) is required in each SRP Center grant application. In support of the NIEHS Strategic Plan and its cross-cutting themes, SRP values not only solutions-focused research, but also its translation to enable health promotion, disease prevention, and evidence-based intervention. This is accomplished through two key core activities:

• Translational Research – The TREC will coordinate with each research project to explore translational research opportunities appropriate for the stage and type of science, identifying opportunities to move science across the research continuum, linking with potential stakeholders/end-users of the research results, and tailoring communication strategies for various audiences.
• Stakeholder Engagement – The TREC is also expected to develop plans for the Overall Center’s multi-directional engagement with key partners, with the ultimate goal of enabling impacted communities and other stakeholders to be participants in the reduction of the amount and toxicity of hazardous substances in their environment (i.e., SRP's fourth mandate).

Research Projects: Collectively, the Center's research projects (consisting of biomedical research projects and environmental science and engineering research projects) should represent a range of basic and applied research that contributes to the problem-based, solution-oriented goal of the Center. Projects should be hypothesis-driven or product-oriented research.

• Biomedical Research (BMR) Projects: A minimum of one (maximum of two) 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.
• Environmental Science and Engineering (ESE) Projects: A minimum of one (maximum of two) 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.  At least one ESE project should support SRP’s fourth mandate “basic biological, chemical, and physical methods to reduce the amount and toxicity of hazardous substances.” ESE projects include, but would not be limited to: remediation, geochemistry, ecology, civil/environmental engineering, geology, microbiology, fate and transport, hydrogeology, and detection sciences. 

(Note: Centers should be comprised of a minimum of 3 (maximum of 4) Research Projects and could be a combination of 2 BMR/2 ESE or 2 BMR/1 ESE or 1 BMR/2 ESE.)

Research Support Core (Optional): Applicants may include a Research Support Core (RSC) to provide centralized resources/services in support of the scientific goals of at least two projects. This may include, but would not be limited to, analytical services, biostatistics, bioinformatics, geographical information systems, data visualization, and computational modeling, etc.

Integration: The SRP considers integration of a Center's projects and core as an important way to target complex problem(s) relevant to the SRP's mandates.  A Center should demonstrate evidence of synergy between its projects and core - including interaction between BMR and ESE disciplines.

Scope of the SRP Center Grant

The scope of the SRP Center is defined by the SRP Mandates. Research and supporting activities under this NOFO 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.

• Mechanistic and/or mode of action research that includes laboratory- and population-based (i.e. epidemiology) studies for unraveling critical biological pathways that contribute to disease when perturbed by environmental contaminants. 
• Molecular, genetic, epigenetic, and biochemical research that describe the normal physiological events and processes that contribute to good health and the roles that hazardous substances play in their disruption and progression of disease. 
• Cumulative impacts of combined exposures to hazardous substances and how they interplay with biological responses and host factors (e.g., nutrition, co-morbid disease/conditions, lifestyle habits, psychosocial stressors; genetic variability, epigenetic factors, sex, age, timing of exposure, resilience, and allostatic load) that impact disease susceptibility. 
• Application of novel and advanced tools and methods such as high-throughput screening techniques, “multi-omics” approaches, next generation sequencing, New Approach Methodologies (NAMs), tissue engineering (including organotypic tissues), in silico modeling, multi-scale modeling, artificial intelligence/machine learning, and systems biology approaches to improve predictive capabilities and characterize health effects. 
• Discovery and validation of technologies useful for exposure assessment, indicators of biological response (e.g., biomarkers of exposure and disease), and disease susceptibility.

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

• Integrated human and ecologic risk models to assist in making cost-effective and protective recommendations.  
• Novel methods/approaches/statistical/combinatorial models to integrate exposure over time, determining windows of susceptibility (e.g., early life and childhood exposures), and characterizing the attributable risk from multiple exposures experienced over one’s lifetime that result in chronic disease.   
• Methods that include incorporation of the exposome; microbiome; genetic variations (e.g., somatic mutations); adverse outcome, causal, and other pathway modeling; and macromolecular alterations (e.g., epigenetics) to identify susceptibility or resilience factors. 
• Exposure science research such as: fate and transport; transformation of contaminants in the environment; contaminant bioaccessibility/bioavailability in the environment and in biological systems; biological response indicators (e.g., biomarkers); factors that influence biological susceptibility/resilience (e.g. inflammation status); and quantifying body burden.

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

• Development and application of new and advanced technologies for detection and monitoring of hazardous substances. 
• Development of novel methods and devices that offer precise and low-cost measuring capabilities of hazardous substances (e.g., bioassays or ecological indicators that assess toxicity to biological systems at sites complicated by multiple contaminant streams or complex environmental media).
• Innovative tools that allow for real-time, minimally invasive, on-site monitoring. 
• Devices that are capable of multi-analyte readings and/or determination of the degree of bioaccessibilty/bioavailability of a contaminant (e.g., model organisms, passive sampling devices). 
• 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) as well as device reuse, waste generation, and utilization of non-toxic components (particularly for in-situ devices).

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

• Research investigating the mechanisms of nutrition, lifestyle, or other co-factors to mitigate toxicity and improve public health. 
• Technologies/approaches that reduce the amount and toxicity of hazardous substances. 
• Cost-effective technologies that reduce and/or eliminate contamination in media such as groundwater, sediments, fractured bedrock, soils, and/or drinking water. 
• Studies that validate or confirm risk reduction from prevention or intervention activities.
• Research to understand how to effectively reduce the amount and toxicity of hazardous substances and any unintended toxicological consequences of a remediation technology. 

(Note: There is a requirement for Center applications to include at least one ESE project that supports Mandate #4.)

Examples of Research Topics: For a listing of research areas of interest to the SRP and its end-users, please refer to the Suggested Research and Activities document found on the SRP website.

Applicants are also encouraged to propose research that fills gaps or needs not currently addressed within the SRP. Applicants are also encouraged to review its list of current grant recipients.

Hazardous Substances: The following substances are relevant to SRP:

• 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 these hazardous substances.
• 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.

The applicants should refer to the SRP's website for a list of hazardous substances, including emerging contaminants, that have been suggested for study by SRP end-users/stakeholders.

Applicants are strongly encouraged to consult with SRP staff for specific questions about the relevancy of a hazardous substance for this NOFO, 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, SRP encourages investigations on understudied chemicals found at Superfund sites to gain an understanding their health effects.

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

The SRP is not a site-specific program; research activities proposed by the Center are not required to take place on Superfund or hazardous waste sites.  However, whether through research project or core activity(ies), Centers are strongly encouraged to seek opportunities for interactions at Superfund sites, managed hazardous waste sites, and facilities where hazardous substances are located, which greatly increases the positive impact of SRP research and its utility to end-users. Superfund sites serve as a good conceptual model for research focusing on hazardous substances.  (Note: The SRP is a research program, and activities that propose preliminary site assessment activities may not be considered responsive.) If on-site activities will be conducted, researchers must coordinate with appropriate federal/state/local/Tribal agencies and site officials in the early stages of project development and throughout the process. They should also observe best safety practices and include a process and timeline for reporting results. When applicable, applicants must:

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

Links to end-user points of contact and suggestions for Hazardous Waste Site access are included on the following webpage (under Additional Resources).

Annual Meetings

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

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

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

Section II. Award Information

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

Section III. Eligibility Information

1. Eligible Applicants

Higher Education Institutions - Includes all types

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

Foreign Organizations/International Collaborations

Non-domestic (non-U.S.) Entities (Foreign Organization) are not eligible to apply.

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

Foreign components, as defined in the NIH Grants Policy Statement, are not allowed. 

Applicant organizations

Applicant organizations must complete and maintain the following registrations as described in the How to Apply- 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. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications for additional information.

• 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. Foreign organizations must obtain a NATO Commercial and Government Entity (NCAGE) Code (in lieu of a CAGE code) in order to register in SAM.
  • Unique Entity Identifier (UEI)- A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
• eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.gov registration; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov – Applicants must have an active SAM registration in order to complete the Grants.gov registration.

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

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

All PD(s)/PI(s) must be registered with ORCID. The personal profile associated with the PD(s)/PI(s) eRA Commons account must be linked to a valid ORCID ID. For more information on linking an ORCID ID to an eRA Commons personal profile see the ORCID topic in our eRA Commons online help. 

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. 

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 How to Apply - Application Guide.

2. Cost Sharing

This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement Section 1.2- Definitions of Terms.

3. Additional Information on Eligibility

Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

The NIH will not accept duplicate or highly overlapping applications under review at the same time per NIH Grants Policy Statement Section 2.3.7.4 Submission of Resubmission Application. This means that the NIH will not accept:

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

Based on 42 USC 9660(a)(3) eligible applicants are limited to accredited institutes of higher education. Eligible applicants are permitted under the law, and encouraged by NIEHS, to subcontract as appropriate with other organizations 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. 

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 NOFO. See the administrative office for instructions if planning 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 How to Apply - Application Guide, except where instructed in this notice of funding opportunity to do otherwise (in this NOFO, in a policy notice, or other notice from NIH Guide for Grants and Contracts) and where instructions in the How to Apply - Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. Conformance to the requirements in the How to Apply - Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Page Limitations

All page limitations described in the How to Apply- 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 How to Apply- Application Guide and should be used for preparing a multi-component application.

Note for Research Projects:

• Biomedical Research Projects (BMR): required, minimum of 1; maximum of 2
• Environmental Science and Engineering Research Projects (ESE): required, minimum of 1; maximum of 2

Centers must be comprised of a minimum of 3 (maximum of 4) Research Projects and could be a combination of 2 BMR/2 ESE or 2 BMR/1 ESE or 1 BMR/2 ESE.

Overall Component

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

All instructions in the How to Apply - 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)

Follow standard instructions.

Research & Related Other Project Information (Overall)

Follow standard instructions.

Project Summary/Abstract: For the Overall Component, applicants must include a Project Summary/Abstract that describes:

• The scientific problem(s)/overall hypothesis being addressed by the Overall Center and how the Center plans to solve these target problem(s) related to health effects, risk, detection and/or remediation of hazardous substances (i.e., with relevance to SRP mandates and Superfund).
• An overall indication of the importance of the proposed science and what the Center proposes to accomplish.
• Which hazardous substances are being evaluated, study sites, research approaches, model organisms/biological systems, disease pathways, etc. 
• Aspects of the Center that are particularly innovative or paradigm-shifting.
• How the cores will be integrated into the Center.
• How the Center will reduce disease/dysfunction and improve public health. 

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, end-users/stakeholders, Superfund, and the SRP mandates. 

Other Attachments: The following "Other Attachments" must 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.  List the names of the respective component leads (including the Administrative Core's Data Management and Training Coordinators as well as the TREC Coordinator(s)). Applicants should clearly indicate which projects are BMR and which are ESE.  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 (by project title and project/core leader) and the purpose of the interaction for the achievement of the Center's overall objectives. This table should be provided as a pdf file titled "Table of Integration with Center."
• Table of End-users/Stakeholders and Field Sites. To assist the reviewers in identifying significant project and core interactions with key end-users/stakeholders and field sites, a table should be provided showing which projects and cores interact with which end-users, stakeholders, and field sites as well as the type of interaction/activity. End-users/stakeholders would include federal/state/local/Tribal agencies, community groups, community(ies), and other end-users with significant ongoing and/or planned interactions. Field sites would include Superfund, hazardous waste sites, facilities at which hazardous substances are located, or other study/research sites. This table should be provided as a pdf file titled "Table of End-users and Field Sites."
• For Renewal/Resubmissions:
  • 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/coordinator) 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 (BMR) and which are considered environmental science and engineering (ESE) research.  Indicate which ESE project(s) supports Mandate 4. 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".

Please refer to the following website for example illustrations of the tables.

Project/Performance Site Locations (Overall)

Enter primary site only.

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

Research and Related Senior/Key Person Profile (Overall)

Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this NOFO) 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 and Revision 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 and Superfund. The Specific Aims section should provide greater scientific detail and approaches than the overall Summary/Abstract.  In addition, it should be clear how the components of the Center will interact to solve the target scientific problem(s) proposed by the Center, and the role of each project and core in contributing to resolving the problem(s) stated in the application.

Research Strategy: The Research Strategy section should highlight the following subsections: Significance and Relevance to SRP Mandates and Superfund; Research Team; Innovation, Approach; Environment; and Center Integration. Descriptions should include:

Significance and Relevance to SRP Mandates and Superfund

• How the hazardous substance(s) being studied, and their subsequent research findings/results, are relevant to the SRP and Superfund.
• The role that each project and core have in contributing to resolving the problem(s) related to health effects, risk, detection and/or remediation of hazardous.
• Identifying where the research can make a big impact in reducing the prevalence and burden of disease/dysfunction from exposure to hazardous substances as well as an understanding of the molecular, cellular, and pathophysiologic parameters associated with these hazardous substances.
• How the Overall Center is relevant to SRP’s end-users (e.g., the agencies responsible for management of sites impacted by hazardous substances, as well as the individuals and communities impacted by these sites) and other Center stakeholders (as applicable).
• Information/data to assist risk assessors and remediation managers at sites impacted by hazardous substances.

Research Team

• An introduction to the leadership and key personnel of the Center, highlighting the complementary and integrated expertise and breadth of disciplines among the project and core leaders/coordinators to accomplish the goals of the Center (without duplicating information in biosketches).
• Outline, on a per project/core basis, the expertise associated with the hazardous substances being evaluated, and the capability of the research team to access study sites, conduct the research approaches, and knowledge of model systems/disease pathways, etc.
• The successes and accomplishments of the team as a whole in advancing their respective field - particularly with regard to integration between disciplines.
• A brief description of plans for the Administrative Core and the TREC (and RSC, if applicable) to facilitate the overall goals of the Center and maintain organization of the Center.

Innovation, Approach, and Environment:

• The importance of the knowledge gap(s) the Center is fulfilling.
• Novel theoretical concepts, approaches or methodologies, instrumentation, or interventions including novel adaptations of technologies from one field to another (i.e., multi-disciplinary approaches).
• How the Center’s strategies ensure a robust, unbiased approach.
• The degree to which the experimental design(s) recapitulate real world exposures.
• How the university environment supports the Center's problem-solving goals (e.g., institutional support; and/or interdepartmental/interinstitutional cooperation).

Center Integration:

• The multidisciplinary and interdisciplinary nature of the Center.
• The integration and interactions between the BMR and ESE projects and between the various projects and the cores (i.e., the Administrative Core, TREC, and the RSC (if applicable)).
• How each project and core contribute to the Center’s theme, and how the Overall Center is greater than the sum of its parts (i.e., components).

(For Center integration, the applicant may also wish to cross-reference other sections of the application where more detailed information is found. For example, the Overall "Other Attachments" includes the “Center Organizational Structure”; “Integration with Center,” “End-users and Field Sites,” and “Changes to Projects and Cores” (as applicable).  Other sections where interaction may be demonstrated include the Relation to Overall Center sections.)

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 progress report 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).  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. 
• 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 also provide an Overall Center timeline for the completion of problem-solving goals. 

Letters of Support: Applicants should include all letters of support pertaining to the Overall Center in this section.  For example, these letters may include collaborative agreements for the entire Center (e.g., from potential end-users/stakeholders), institutional support (if applicable), etc.  However, only those Letters of Support that pertain to a specific project/core should be placed in the respective project/core. Applications that propose work with American Indian or Alaska Native populations, tribes or communities must include letters of support from the appropriate tribal officials and/or tribal organizations as applicable. 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 How to Apply - Application Guide.

Other Plan(s): 

All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions:

• A Data Management and Sharing Plan (DMS Plan) is required for any NIH-funded or conducted research that will generate scientific data. Applicants must submit the DMS Plan at the time of application using the NIH DMS Plan Format Page. The DMS Plan must address the elements in the structured format should not exceed two (2) pages. Where the DMS Plan Format Page requires a “Yes or No” response, no additional narrative is allowed. The Data Management and Sharing (DMS) Plan must be provided in the Overall component.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in How to Apply- Application Guide; any instructions provided here are in addition to the How to Apply - 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 How to Apply - 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 How to Apply - 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 How to Apply- Application Guide must be followed.

PHS Assignment Request Form (Overall)

All instructions in the How to Apply- Application Guide must be followed.

Administrative Core

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

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

SF424 (R&R) Cover (Administrative Core)

Complete only the following fields:

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

PHS 398 Cover Page Supplement (Administrative Core)

Follow standard instructions.

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 provide leadership and oversight to the Center and ensure that the Center’s BMR and ESE projects and TREC and RSC (if applicable) cores are being supported to achieve the Center’s goals.
• Specific activities and innovative plans for supporting data management, which includes key activities that will be conducted by the Data Management Coordinator (e.g., how they will support the management and integration of data assets across the Center and how they will leverage institutional and computing infrastructure).
• Specific activities for coordinating trainee activities for the projects and cores within the Center tailored to fit the overall goals of the Center, including how they will support the trainees' professional and multidisciplinary research experiences.

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, end-users/stakeholders, Superfund, and the SRP mandates.

Other Attachments: Trainee List (For renewal applications only). Renewal applications must 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 Center 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, project number/core name, position during training experience, current position and affiliation, and location of affiliation (i.e., city/state). An illustration of the "Trainee List" can be found here.

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 (e.g., Center Director, Data Management Coordinator, and Training Coordinator).
• 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: The Data Management Coordinator and Training Coordinator (along with their biosketches) should be named in the application. A Deputy Director may also be named, but is not required, within the Administrative Core.  Center Directors 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 BMR, the Deputy Director would have expertise in ESE. The Administrative Core should also designate a point of contact to inform SRP staff of dataset deposition and training activities/accomplishments through the optional SRP Data Collection Tool.

Budget (Administrative Core)

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

• The Center Director must commit a minimum of 1.8 person months per year to the administration of the Center.  (Note: The sum of Direct Costs for the Administrative Core and the TREC cannot exceed 25% of the total Direct Costs of the Center per year.)
• Salaries for the Center Director, Data Management Coordinator, Training Coordinator, Center Administrator, and for individuals responsible for Data Collection Tool entry may be included in the Administrative Core budget, if not already included in other project/core budgets.
• Given the limited core budget, data management and sharing expenses are expected to be provided through their respective project or core components rather than the Administrative Core.
• Training activities that may be supported by the Administrative Core 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, travel of trainees to scientific meetings.
• Compensation for trainees (e.g., graduate students and Post-Docs) is expected to be provided through their respective project or core components. Other related training costs (e.g., research equipment, supplies) should be part of the project or core budgets rather than the Administrative Core budget.
• KC Donnelly Externships: applicants may request up to 2 KC Donnelly externships per year. KC Donnelly externships should be listed as a separate line item under "Other" in the budget section. Each KC Donnelly externship is limited to $10,000 direct costs for support up to three (3) months, consisting of supplies, travel to externship site(s), housing costs, and travel to the Annual SRP Grant Recipient Meeting to present the externship experience. In the budget justification, the KC Donnelly expenses should be clearly detailed (e.g., details on level of effort and salary of core leader/staff, description of other expenses, etc.).
• Annual SRP Grant Recipient Meetings: Funds for travel by required staff (i.e., Center Director, Center Administrator, Data Management Coordinator, Training Coordinator, TREC leader(s), 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. An SRP Center should expect to host the Annual SRP Grant Recipient Meeting once within the project period and may want to set funds aside for the event. Please consult with program staff for details.

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 and Revision 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, in coordination with the Center's projects and cores, about how the Core will provide leadership to the Center; support effective data management for all relevant Center components; and promote interdisciplinary and professional development opportunities for the Centers trainees to achieve the Center's goals.   

Research Strategy: The research strategy should include a detailed description of how the Core will provide leadership to the Center; support effective data management for all relevant Center components and support NIH's data sharing policy; and promote interdisciplinary and professional development opportunities for the Centers trainees to achieve the Center's goals.   

The leadership description should include how the Core (and the Center Director) will:

• Provide guidance in ensuring the synthesis of findings and activities from research projects and cores towards addressing the central problem/objective proposed by the Center.
• Create an infrastructure that promotes cross-discipline interactions and integration among all the projects and cores (e.g., lines of communication among the Center Director and the Center's project and core leaders).
• Achieve its administrative functions of leadership and integration.
• Encourage and ensure the integration and interaction of cross-disciplinary research (i.e., between the BMR and ESE projects) within the Center.
• Plan, coordinate, and ensure the success of the Center's core activities (e.g., coordinating activities with TREC and, as applicable, RSC functions)
• How the core will oversee fiscal and resource management; and providing quality management.
• Ensure that updates (e.g., dataset deposition and training activities/accomplishments) are made to the optional SRP Data Collection Tool and designate points of contact responsible for reporting this information, as well as a plan for frequency of reporting.
• Provide a strategy for personnel management changes.
• Describe the role(s) of advisory groups and consultants.

External Advisory Committee. To aid the Center Director in achieving the goals set forth by the Center, the Administrative Core is required to establish an External Advisory Committee (EAC).  The composition of the EAC should reflect the goals of the Center and should include appropriate scientific expertise and appropriate end-users/stakeholders (e.g., representatives from federal/state/local agencies (as applicable), EPA, ATSDR, industry, and/or community organizations). 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 substantial input into the design of the application.  The EAC should provide guidance to the Center 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 SRP Mandates, and Superfund.
• The integration of research across disciplines and components.
• The effectiveness of data management activities in linking projects within the Center and other opportunities for data exchange with external data sources or other end-users.
• The effectiveness of translational research and engagement functions in linking projects to end-users.
• The appropriateness of training activities (especially cross-disciplinary).
• Discussion of projects that should be continued, modified, or discontinued and strategy for making changes to projects.

The Data Management description should include how the Data Management Coordinator will:

• Serve as a resource for facilitating and supporting effective data management, integration, and analysis across the Center.
• Provide relevant expertise in data management, and, as applicable, other expertise relevant to the position (e.g., data visualization, information and knowledge management, software development, semantic engineering, etc.).
• Promote interaction with the Project/Core Leaders over the course of the research projects/cores (e.g., monthly meetings) and leverage institutional and computing infrastructure.
• Encourage project/core leaders and trainees to analyze shared datasets; and create opportunities for exploring new linkages between data and the formation of new hypotheses.
• Provide additional assistance to projects/cores to advance the goals of the Center.
• Seek out data coordination and sharing opportunities within the SRP grant recipient community (e.g., shared virtual platforms, data commons) and participate in the SRP Data Management Coordinator conference calls/webinars, as appropriate (The Administrative Core should also designate a point of contact to inform SRP staff of dataset deposition through the optional SRP Data Collection Tool for when data is deposited).

The Training description may include, but is not limited to, how the Training Coordinator will provide:

• Opportunities for trainees to participate in the Center's training activities and in the Center’s overall research program, projects, and cores (e.g., cross-disciplinary laboratory experiences, seminar series, training in small business / entrepreneurship, certification opportunities (e.g., HAZWOPER training); and travel to scientific meetings, etc).
• Opportunities to enhance trainees’ professional career development and mentoring of other SRP and non-SRP trainees (e.g., undergraduates, high school students,).
• Interactive opportunities with the Data Management Coordinator in training and education on data management and analysis practices and data sharing.
• Trainee participation in the TREC functions, as appropriate.
• Information about the Center's trainees and their activities (e.g., fellowships, awards, employment, other education, product developments, publications, funding received, posters at scientific conferences, and mentoring opportunities) to NIEHS SRP Staff and identifying a point of contact for ensuring that trainee information/activities are entered into the optional SRP Data Collection Tool and a timeline for the frequency of submissions to the tool.
• Encouragement for their trainees to participate in KC Donnelly externships (limited to two (2) per year for a Center’s trainees), which was developed by the SRP as an exchange program for funds to be set-aside for selected trainees to conduct research and/or activities at another SRP Center or at a federal/state/local or Tribal agency. These activities should be in coordination with the Administrative Core and Project/Core leaders and should include:
  • A plan for recruiting and selecting Center trainees for the externships.
  • A description of how the trainees' activities will be guided.
  • How performance will be monitored and evaluated.
• A plan to recruit trainee applicants for the SRP Karen Wetterhahn Memorial Award, which was established by the SRP as an annual award to recognize an outstanding graduate student or post-doctoral researcher that best demonstrates qualities of scientific excellence and leadership.
• Provide points of contact for regular SRP-hosted conference calls/webinars relevant to training (e.g., networking calls for Training Coordinators and representative graduate students and Post-Docs from the Center).

Recommended data management and training coordination activities have been listed in the "Suggested Research and Activities" document found on the SRP website.

(Note: If KC Donnelly Externships will be conducted as part of training activities, the Administrative Core will report, in their annual Research Performance Progress Report (RPPR), the trainees' names, a brief description of the externship activities/objectives, how the externship(s) fits within the scope of the parent grant, anticipated outcomes, timeline, and mentorship plan. The PD/PI is also strongly encouraged to contact their Program Administrator to discuss their proposed externship plans to ensure that it fulfills the description and goals of the KC Donnelly Externship Program.)

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 Coordinator; and Training Coordinator should also be included.  Applicants may refer to their “Table of Integration with Center” attachment (see Overall Section “Other Attachments”) as well as the “TRP” in the Project/Core’s “Resource Sharing Plan” section for points of coordination with the Administrative Core and Center Components.

Renewal Applications: Renewal applications must include, in the Research Strategy, a progress report that describes the achievements of the Administrative Core. This is also the section where the Center's data management (i.e., formerly referred to as the Data Management and Analysis Core) and training (i.e., formerly referred to as the Research Experience and Training Coordination Core) 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, end-users/stakeholders, communities, institutional support, 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 data repository facilities and institutional support (if applicable), when leveraging such resources for the Center's data management and training activities, are strongly encouraged. Applications that propose work with American Indian or Alaska Native populations, tribes or communities must include letters of support from the appropriate tribal officials and/or tribal organizations as applicable. 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, with the following modification: a TRP may be included to describe the Administrative Core's role in working with project (and cores, if applicable) to develop plans for sharing research resources and findings beyond the individual component. This would potentially describe the following:

• Plans for interaction between the project (and/or core, as applicable) and Center’s Data Management Coordinator (e.g., how data sets will be shared with appropriate end-users).
• Plans for interaction between the project (and/or core, as applicable) and the Center’s Training Coordinator (e.g., identifying opportunities for trainee career development and cross-training research experiences).

These plans should cross-reference the components' TRP, and should not duplicate, but provide additional technical details that may not be found in the component TRP.

Other Plan(s):

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

• Do not include a Data Management and Sharing (DMS) Plan within this Component. If a DMS Plan is required for this NOFO, it must be included within the Overall Component. 

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 How to Apply- 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 How to Apply- Application Guide must be followed.

Note: Prevention/Intervention activities involving human subjects may be classed as a clinical trial. Need help determining whether you are doing a clinical trial?

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 How to Apply- Application Guide must be followed.

Translational Research and Engagement Core

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

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

SF424 (R&R) Cover (Translational Research and 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 (Translational Research and Engagement Core)

Follow standard instructions.

Research & Related Other Project Information (Translational Research and 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 TREC will support the Center.
• Activities and innovative plans for the Core and how it will facilitate plans for translational research and communication of the Center’s projects (and cores, if applicable) to end-users/stakeholders.
• Indication about which community or communities and other end-users/stakeholders are planned for partnerships, as well as which hazardous substances are impacting these groups.
• Activities and innovative plans for engaging the community/end-users/stakeholders in appropriate prevention and intervention activities.
• Description of how the objectives and goals of the Core as it relates to the SRP Mandates and Superfund.

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, end-users/stakeholders, Superfund, and the SRP.  

Project /Performance Site Location(s) (Translational Research and 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 (Translational Research and 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 TREC leader/staff should have appropriate expertise to conduct translational and engagement activities and work with communities/end-users affected by hazardous substances.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component (e.g., TREC Coordinator(s)).
• 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: The TREC Coordinator(s) (along with their biosketches) should be named in the application. The TREC should also identify the individual(s) responsible for entering TREC activities into the optional SRP Data Collection Tool.

Budget (Translational Research and Engagement Core)

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

• The sum of Direct Costs for the Administrative Core and TREC cannot exceed 25% of the total Direct Costs of the Center per year.  In addition, given the limited core budget, some translational research activities (e.g., technology transfer expenses) may be included in their respective project or core components rather than the TREC.

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 (Translational Research and Engagement Core)

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

Specific Aims:

The specific aims should include how the TREC will facilitate translational research activities for each project and how the TREC will coordinate Center engagement with communities, end-users, and/or stakeholders. The specific aims should also indicate which community or communities, end-users, and/or stakeholders are planned for partnerships, as well as which hazardous substances are of interest to the community or communities, end-users, and/or stakeholders.  Applicants should highlight specific activities and innovative plans for appropriate prevention/intervention activities, tailored to fit in the overall goals of the Center.  The specific aims section should also contain a brief statement about how the Core integrates with the rest of the Center. Specific Aims should also describe the objectives and goals of the core as it relates to the SRP Mandates and Superfund.

Research Strategy: The research strategy should indicate how the TREC will achieve the Center's translational research goals and conduct engagement activities with communities, end-users, and/or stakeholders and cross-reference, as applicable, the Table of End-user/Stakeholders and Field Sites.

The following objectives should be described in the TREC’s Research Strategy:

Translational Research:

• Coordination to explore translational research opportunities appropriate for the stage and type of science for each research project.
• Development of a TRP for each of the Center research projects and cross-reference the project’s TRP (located in the projects’ Resource Sharing Plans), where details should be provided.
• Identify opportunities to move science across the research continuum and linking potential stakeholders/end-users with the Center's research results.
• Work with project leaders on research communication to a variety of audiences using an assortment of strategies (e.g., review articles; websites, videos, newspapers, webinars, social media, fact sheets).
• Offering training in the form of short courses and continuing education for personnel engaged in the handling of hazardous substances (i.e., the substances being evaluated by the Center).
• Disseminating timely information to SRP staff, other SRP Centers, and the public (e.g., high impact publications, press releases).
• Seek opportunities for formal and informal technology transfer mechanisms.
• Plan to share information from the Center to other important end-users such as formal/informal educational groups, hazardous waste practitioners, communities, the public, and other academic researchers.
• Communication within the Center as well as across the greater SRP network (e.g., other SRP Centers, SRP grant recipients; participation in regular SRP-hosted TREC events (networking calls, webinars); and NIH/NIEHS networking communities (e.g., Partnerships for Environmental Public Health (PEPH) or the NIH Disaster Response Research Program (DR2)). (Note: A point of contact should be indicated in the Research Strategy section for regular SRP TREC webinars/conference calls.)
• Plans for working with the Administrative Core to ensure reporting of translational research and other activities to SRP staff at NIEHS (e.g., using the optional SRP Data Collection Tool (DCT) of webinars/meetings, interactions with end-users, trainee/investigator awards, news articles, and publications).
• Interactions with the Administrative Core, such as through data management/sharing and trainee engagement (as applicable).

(For all translational research activities, best communication practices must be utilized (please see the NIH website on plain language).

Stakeholder Engagement:

• Plan(s) for the transfer and utilization of the knowledge gained from Center’s projects’ research findings to government or marketplace entities.
• Multi-directional communication strategies to understand real and immediate needs of relevant federal, state, local, and/or Tribal agencies and communities to ensure the impact of the Center's research.
• Plans for promotion of solution-oriented research and activities that are intervention and prevention-related (and that are consistent with SRP's fourth mandate) that could include:
  • Identifying opportunities for communities to reduce exposures (e.g., promoting nutrition, exercise, and remediation strategies).
  • Conducting an inventory of community-level environmental and health resources/needs to help prioritize prevention of exposures.
  • Applying lessons learned from prevention and intervention activities specific for one community to other communities.
• Plans to engage with communities impacted by sites with hazardous substances (especially those that the Center is focused upon), which may include:
  • Providing scientific expertise in response to a community’s questions.
  • Assisting a community in accessing pertinent information regarding the Center's research.

(Note: TREC activities may include, but are not required, biological or environmental sample collection as part of their core prevention and intervention activities. TRECs 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/end-users are receiving scientifically defensible data. (If a TREC plans to collect biological samples, the TREC must indicate "delayed onset" for human subjects. If the samples are collected by another Project or Core, the TREC must reference the process from the Core or Project’s section of the application. Please visit the NIH Human Subject Research website for more information.   In addition, some activities, including surveys with the intent to evaluate behavior change, may fall under the NIH definition of a clinical trial.  Please visit the NIH Clinical Trial website for more information about determining if the activity should be classified as a clinical trial.)

Examples of activities for the TREC may be found in the Suggested Research and Activities document found on the SRP website.

Relation to Overall Center: The Research Strategy section of the TREC should include a "Relation to Overall Center" statement. In this statement, include how the TREC's activities relate to the research goals of the overall Center; how the TREC will integrate with other projects and cores (applicants may wish to cross-reference TRPs located in the component “Resource Sharing Plan”); Interactions with the Administrative Core should also be included.

Renewal Applications: Progress Reports should be included of the Research Strategy of the TREC (i.e., formerly referred to as Administrative Core's research translation activities and Community Engagement Core activities). 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, end-users/stakeholders, communities, institutional support, and/or entities whose resources may be utilized as part of the TREC (e.g., sample sharing, access to field site, etc.).  Applications that propose work with American Indian or Alaska Native populations, tribes or communities must include letters of support from the appropriate tribal officials and/or tribal organizations as applicable. 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.

Other Plan(s):

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

• Do not include a Data Management and Sharing (DMS) Plan within this Component. If a DMS Plan is required for this NOFO, it must be included within the Overall Component. 

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 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 (Translational Research and 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 How to Apply- 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 How to Apply- Application Guide must be followed.

Note: Prevention/Intervention activities involving human subjects may be classed as a clinical trial. Need help determining whether you are doing a clinical trial?

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 How to Apply- Application Guide must be followed.

Research Project

The SRP accepts research projects that range from fundamental to applied science. Applicants are encouraged to frame their research in terms of testable hypotheses. However, for research that is more applied (i.e., product oriented) or hypothesis generating, applicants should delineate tasks, with clearly stated benchmarks of success.  When proposing product-oriented projects, applicants should consider including the technology readiness level.

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

All instructions in the How to Apply- 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)

Follow standard instructions.

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: The Project Summary/Abstract should briefly describe:

• The objectives of the project and how the project will support the problem-solving goals of the Center.
• How the project relates to the SRP's mandates, drawing connections to Superfund, as appropriate.
• The hazardous substances being evaluated, the exposure context (as appropriate), the model organisms/biological systems, disease pathways, research approaches, environmental media, etc., as well as study sites (if applicable).
• Aspects of the application that are innovative, paradigm-shifting, and/or gap-filling.
• Plans for engaging end-users/stakeholders or communities, if applicable.

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, end-users/stakeholders, Superfund, and the SRP mandates. 

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.

• Include budget information for Data Management and Sharing Costs, if applicable to the Project.

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 and Revision 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 and Superfund. The specific aims section should also include a brief statement about how the project integrates with the rest of the Center and how the project contributes to the other projects and cores.  In addition, applicants are encouraged to identify specific aim(s) that are considered high-risk, high-reward. 

Research Strategy: The following subsections are recommended: Significance and Relevance to SRP Mandates and Superfund; Investigators; Innovation; Approach; Environment; and Center Integration. In addition, the Research Strategy section should highlight:

• The scientific problem(s) being addressed by the project and provide a timeline for project completion. 
• How the project advances knowledge or provides resources/technologies that could be utilized to improve human health, addresses uncertainty of risk, or improve the quality of the environment (i.e., remediation); and how the project provides rigorous scientific data that could be used by end-users/stakeholders.
• The hazardous substance (and potential metabolites) being studied.
• How the proposed methodology and analyses are appropriate to accomplish the specific aims of the project as well as alternative strategies, and benchmarks for success.
• The justification of approaches.  As examples:
  • For BMR: an appropriate model for the exposure-disease paradigm under investigation (if using vertebrate animals, explain why other non-vertebrate approaches are not satisfactory); justification of sample size in population studies through power calculations and justification of dose in mechanistic/toxicological studies.
  • For ESE: appropriateness of model, sample size, environmental media, the conditions in which the technology is being utilized, target detection/sensing goals, value-added of technology relative to existing technologies.
• Innovative aspects of the project including whether the project challenges current research paradigms by utilizing novel theoretical concepts, approaches, methodologies, instrumentation, or interventions.
• A description of how the project contributes to the Overall SRP Center and what will be gained to advance public health.
• For projects that involve significant interactions with communities, include the following:
  • A description of the defined community of interest or community partner and the community's and researchers' roles (e.g., the multi-directional relationship between the researcher(s) and the community).
  • How the research activity will lead to improved public understanding of the research proposed by the Center.
  • What is the generalizability of the research to other communities.
  • 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 (including a timeline) of the activity.
  • A management plan for maintaining transparent communications between the community and the academic partners (e.g., including plans for lines of communication in challenging situations, such as disaster or other emergency).

Note: for additional information on what to include in Human Subjects research studies, please follow SF424 and NIH Humans Subjects Research guidelines.

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 crossed-referenced between projects/cores.  Interactions with the Administrative Core's (i.e., data management and training) and TREC's functions should also be included.  

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, end-users/stakeholders, communities, institutional support, and/or entities whose resources may be utilized as part of the research project (e.g., sample sharing, access to field site, etc.). Applications that propose work with American Indian or Alaska Native populations, tribes or communities must include letters of support from the appropriate tribal officials and/or tribal organizations as applicable. See SF424 for details.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply- Application Guide, with the following modification: a Translational Research Plan (TRP) should be included for each (project/core) to describe how research resources and findings will be shared beyond the project. This TRP should describe the following:

• Sharing Research Resources and Findings (in coordination with the Administrative Core):
  • Plans for interaction with the Center’s Data Management Coordinator (e.g., how data sets will be shared with appropriate end-users).
  • Plans for interaction with the Center’s Training Coordinator (e.g., identifying opportunities for trainee career development and cross-training research experiences).
• Translational Research (in coordination with the TREC):
  • Identify opportunities to move science across the research continuum.
  • Identify and develop plans to link with potential stakeholders/end-users of the research results including opportunities for technology transfer, facilitating research-related interactions/engagement with other SRP-funded grant recipients, and/or opportunities to engage with impacted communities.
  • Tailor communication strategies for various audiences specific to the project.  

It is recommended to cross-reference the TRP, as appropriate, with the “Table of End-Users/Stakeholders and Field Sites” and with the Administrative Core's data management and training functions and the TREC functions in their respective component sections.  Examples of TRP activities can be found in the Suggested Research and Activities on the following website.

Other Plan(s):

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

• Do not include a Data Management and Sharing (DMS) Plan within this Component. If a DMS Plan is required for this NOFO, it must be included within the Overall Component. 

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 How to Apply- Application Guide; any instructions provided here are in addition to those in the How to Apply- 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 How to Apply- 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 How to Apply- Application Guide must be followed.

Note: Prevention/Intervention activities involving human subjects may be classed as a clinical trial. Need help determining whether you are doing a clinical trial?

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 How to Apply- Application Guide must be followed.

Research Support Core

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

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)

Follow standard instructions.

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 RSC will serve as a resource for the Center.
• Specific activities (e.g., shared laboratory facilities and services), 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, end-users/stakeholders, Superfund, and the SRP.  

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 and Revision applications, an Introduction to Application is allowed for each component.

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

Research Strategy: the applicant should include in the description:

• The services and methodological approaches to be rendered by the Core, why they are not currently available to the Center, and how they are distinct from other facilities at the institution
•  A plan for prioritizing the use of the facility by Center members.
• The role of the core as a resource to the Center as a whole (e.g., how the Core may provide a cost-savings to the Center). 
• How specific Research Projects will use the resources of the core (note: at least 2 research projects must utilize the Core to be responsive to this NOFO. In addition, a RSC is principally designed as a service or resource component; it would be highly unusual to include research in an RSC (a possible exception would be methodology development).
• The ways in which the Core augments interdisciplinary activities and/or integration between projects and cores.
• How the Core will coordinate with the Administrative Core's Data Management Coordinator to facilitate its data management, analysis, and sharing within the Core and the Overall Center and, if applicable, plans to share with the wider research community.
• The professional skills that the core will provide to the Center's trainees (as applicable).

If an RSC provides analytical and quantitative services to the Center, a Quality Assurance Section should be included. The Quality Assurance Section should document a Center's policy on implementing and assessing the effectiveness of its quality assurance and quality control operations. For suggested guidance, please see EPA's Quality Assurance Program.

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 collaborating with the Center's Data Management Coordinator.
• 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.

Relation to Overall Center: The RSC should also include a "Relation to Overall Center" statement. In this statement, include 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 Data Management Coordinator should also be included.  

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, end-users/stakeholders, communities, institutional support, and/or entities whose resources may be utilized as part of the RSC (e.g. sample sharing, access to field site, etc.). Applications that propose work with American Indian or Alaska Native populations, tribes or communities must include letters of support from the appropriate tribal officials and/or tribal organizations as applicable. 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 with the following modification:

An RSC may also provide a TRP (optional) to describe:

• Plans for translational research and sharing of any core-generated research resources and findings (in coordination with the Administrative Core and/or TREC). This may include:
  • Plans for interaction with the Center’s Data Management Coordinator (e.g., how data sets will be shared with appropriate end-users).
  • Plans for interaction with the Center’s Training Coordinator (e.g., identifying opportunities for trainee career development and cross-training research experiences).
  • Opportunities to move science across the research continuum; identify and develop plans to link with potential stakeholders/end-users of the research results including opportunities for technology transfer, facilitating research-related interactions/engagement with other SRP-funded grant recipients, and/or opportunities to engage with impacted communities; tailor communication strategies for various audiences specific to the project.

It is recommended to cross-reference the TRP, as appropriate, with the Administrative Core's data management and training functions and the TREC functions in their respective sections. 

Other Plan(s):

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

• Do not include a Data Management and Sharing (DMS) Plan within this Component. If a DMS Plan is required for this NOFO, it must be included within the Overall Component. 

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 the RSC 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 How to Apply- 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 How to Apply- Application Guide must be followed.

Note: Prevention/Intervention activities involving human subjects may be classed as a clinical trial. Need help determining whether you are doing a clinical trial?

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 How to Apply- Application Guide must be followed.

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

See Part 2. 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. 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 Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications.

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 How to Apply- 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 Section 7.9.1 Selected Items of Cost.

7. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the How to Apply - Application Guide. Paper applications will not be accepted.

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

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

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

Important reminders:

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

The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in How to Apply - 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 components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed. 

Funding Opportunity Webinar

A free informational webinar will be held to provide information about this NOFO. Information about how to register for this webinar can be found on the following website.

Recipients or subrecipients must submit any information related to violations of federal criminal law involving fraud, bribery, or gratuity violations potentially affecting the federal award. See Mandatory Disclosures, 2 CFR 200.113 and NIH Grants Policy Statement Section 4.1.35.

Send written disclosures to the NIH Chief Grants Management Officer listed on the Notice of Award for the IC that funded the award and to the HHS Office of Inspector Grant Self Disclosure Program at grantdisclosures@oig.hhs.gov.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described 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 NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

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

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

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

Significance

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

Specific to this NOFO:

• To what extent does the Center demonstrate strength of relevance to Superfund?
• To what extent does the Center address important gaps in our knowledge of human health effects, risk, detection, and mitigation of hazardous substances (i.e., SRP’s Mandates) in the environment?     
• If successful, how would the Center provide data, information, and knowledge to inform public health and remediation management processes?
• To what extent will the Center further the knowledge and understanding of the physical, chemical, and biological processes of hazardous substances in the environment?
• How will the Center lead to more than incremental advancement, or to what extent 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 project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Specific to this NOFO:

• To what extent do the experience and scientific leadership of the Center's Director (PD/PI) allow them 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? 
• To what degree 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? 

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?

In addition, for applications involving clinical trials

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

Approach

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

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

1) the protection of human subjects from research risks, and
2) inclusion (or exclusion) of individuals on the basis of sex, 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, sex, 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 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?

Specific to this NOFO:

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

Integration of the Center

• To what extent does the Center propose to integrate its BMR and ESE projects and cores (i.e., Administrative, TREC, and if applicable, RSC) to address the central focus of the Center?  
• To what extent have the individual projects been considered as highly meritorious to achieve the goals of the proposed work and Center integration?  
• To what extent is there strong synergy among the combined efforts of the various investigators within the overall Center? 
• To what extent are the size and structure of the Center sufficient to afford effective interaction, but diverse enough in scientific disciplines to achieve meaningful contributions to protect 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 Human Subjects Policies

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for inclusion. 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 three points: (1) a complete description of all proposed procedures including the species, strains, ages, sex, and total numbers of animals to be used; (2) justifications that the species is appropriate for the proposed research and why the research goals cannot be accomplished using an alternative non-animal model; and (3) interventions including analgesia, anesthesia, sedation, palliative care, and humane endpoints that will be used to limit any unavoidable discomfort, distress, pain and injury in the conduct of scientifically valuable research. Methods of euthanasia and justification for selected methods, if NOT consistent with the American Veterinary Medicine Association (AVMA) Guidelines for the Euthanasia of Animals, is also required but is found in a separate section of the application. For additional information on review of the Vertebrate Animals Section, please refer to the Worksheet for Review of the Vertebrate Animals 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 (as applicable), 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 (as applicable), the committee will consider the progress made in the last funding period.

Revisions

For Revisions (as applicable), the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

Additional Review Considerations - Overall

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

Applications from Foreign Organizations

Not Applicable

Select Agent Research

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

Resource Sharing Plans

Reviewers will comment on whether the Resource Sharing Plan(s) (e.g., Sharing Model Organisms) or the rationale for not sharing the resources, is 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.

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).  Core will not receive criterion scores, but each core will receive a descriptive score of acceptable (i.e., strengths balance or outweigh weaknesses) or not acceptable (i.e., weaknesses outweigh strengths).

Review Criteria Specific to Administrative Core

• To what extent are the objectives of the Administrative Core appropriate to reflect the theme and interdisciplinary nature of the Center?
• To what extent is there evidence that the lines of authority and structure are designed for effective management/leadership of the Center?
• To what extent are the qualifications, experience, duties, and time commitments of the Administrative Core staff (e.g., Center Director, Data Management Coordinator, Training Coordinator, and Center Administrator) appropriate?
• If applicable, to what extent is the role/expertise of the Deputy Director appropriate for the Administrative Core?
• To what extent is there adequate evidence of plans to promote and oversee integration/coordination among the Center's components?
• To what extent does the core provide evidence of institutional commitment (e.g., for the research projects, core functions, and the trainees); fiscal/resource/quality management oversight; and support from external partners/communities?
• For the Core's data management functions, to what extent is the institutional and computing infrastructure appropriate and are the approaches, methods, and expertise proposed adequate to achieve objectives?
• For the Core's training functions, to what extent is it likely to ensure effective multi-disciplinary training and opportunities (e.g., K.C. Donnelly externships and SRP Karen Wetterhahn Memorial Award nominations) and professional development (e.g., entrepreneurial/small business training, and/or leadership opportunities) for the Center's trainees?
• To what extent is the plan for reporting updates (e.g., SRP Data Collection Tool) adequate?
• How are milestones delineated, realistic, and appropriate?
• To what extent is there an adequate plan to establish/utilize an external advisory committee (EAC)?
• To what extent do EAC members have the expertise (or proposed expertise for new applicants) to evaluate all projects and cores and represent end-users/stakeholders?

Review Criteria Specific to Translational Research and Engagement Core

• To what extent are the objectives of the Core appropriate to reflect the theme and interdisciplinary nature of the Center and relevance to SRP Mandates and Superfund?
• To what extent does/do the TREC coordinator(s) demonstrate adequate experience to lead the core to ensure success for conducting the proposed Core activities? 
• To what extent are the proposed activities for project/core translational research adequate to achieve the Core's objectives?
• To what extent do the proposed activities identify translational research opportunities on a per-project basis (e.g., TRP)? 
• To what extent does the Core provide a plan for technology transfer (e.g. commercialization of products and moving fundamental research findings to practical application) and engaging with end-users/stakeholders)? 
• To what extent does the Core highlight appropriate prevention/intervention activities tailored to fit the goals of the Center and complement the Center's research? 
• To what extent are the main engagement activities clearly linked with SRP’s fourth mandate, “basic biological, chemical, and physical methods to reduce the amount and toxicity of hazardous substances”? 
• To what extent is the community of interest clearly defined and are roles clearly described?
• To what extent are the objectives of the core of high interest and beneficial to the end-users/community(ies) and their health?
• To what extent is appropriate expertise being allocated to activities (including survey/sampling, as applicable)?  
• As applicable, to what extent is there an adequate plan to integrate activities with the Administrative Core’s Data Management Coordinator (to facilitate data management, analysis, and sharing) and the Training Coordinator (for trainee activities)?

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).

Scored Review Criteria/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 Relation to Overall 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)

• How relevant is the project to SRP Mandates and Superfund?
• To what extent does the project address an important problem or a critical barrier to progress in the field? 
• To what extent is the prior research rigorous to support the proposed project? 
• If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? 
• How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions to drive this field of BMR or ESE?
• If successful, how will the project result in knowledge or resources that could be utilized to improve human health, address uncertainty of risk, or improve the quality of the environment? 
• If successful, how would the project provide data, information, and knowledge to inform the processes of risk assessment or remediation management? 

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)

• To what extent 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, to what extent do they have appropriate experience and training? 
• If the project is collaborative or multi-PD/PI, to what extent do the investigators have complementary and integrated expertise; to what degree 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?
• For clinical trials, does the project use innovative designs such as platform trials, real-time adaptive methods, seamless Phase I/II designs, Bayesian designs or decentralized trial elements, as applicable?

Innovation (Research Projects)

• To what extent 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? 
• To what extent is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?
• To what extent 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)

• To what extent are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the Center?
• To what extent have investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? 
• How have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed?  
• To what extent are potential problems, alternative strategies, and benchmarks for success presented? 
• If the project is in the early stages of development, how will the strategy establish feasibility and will particularly high risk aspects be managed? 
• If an aim is deemed high-risk/high-reward, to what extent does the applicant provide adequate preliminary data to demonstrate the feasibility of the approaches (methodology, tools, techniques, etc.)?
• If the project involves research on Superfund sites, hazardous waste sites or nearby communities, to what extent is the proposed plan to involve the appropriate federal, state, local, or Tribal agencies adequate?
• For each project, to what extent does the TRP adequately describe how translational research and engagement (if applicable) of the project will be conducted?  
• To what extent do the Project investigators have an adequate plan to work in conjunction with the Administrative Core's data management and training functions to identify appropriate opportunities and activities?
• To what extent have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

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

• The protection of human subjects from research risks.
• Inclusion (or exclusion) of individuals on the basis of sex, 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, age,), 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?
• 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)

• To what extent will the scientific environment in which the work will be done contribute to the probability of success? 
• To what extent are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? 
• How 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 the Research Support Core

The Research Support 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).  The Core will not receive criterion scores, but will receive a descriptive score of acceptable (i.e., strengths balance or outweigh weaknesses) or not acceptable (i.e., weaknesses outweigh strengths).

• To what extent are the objectives of the RSC appropriate to the Center?
• To what extent are the approaches and methods proposed adequate to achieve objectives?
• To what extent does the RSC provide essential facilities or service for two or more of the Research Projects?
• To what extent is the Quality Assurance Statement for cores providing quantitative analyses adequate?
• To what extent is there a prioritization plan for use of core facilities/services?
• To what extent is there an adequate plan to coordinate with the Administrative Core's Data Management Coordinator to facilitate data management, analysis, and sharing (and if applicable, with the Training Coordinator to facilitate training in RSC functions)?

Additional Review Criteria – Cores and Research Projects

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)

• To what extent 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)? 
• How will the specific scientific objectives of each project/core benefit significantly from, or depend upon, collaborative interactions with other projects in the Center?

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 Human Subjects Policies

When the proposed project/core involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for inclusion. 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 three points: (1) a complete description of all proposed procedures including the species, strains, ages, sex, and total numbers of animals to be used; (2) justifications that the species is appropriate for the proposed research and why the research goals cannot be accomplished using an alternative non-animal model; and (3) interventions including analgesia, anesthesia, sedation, palliative care, and humane endpoints that will be used to limit any unavoidable discomfort, distress, pain and injury in the conduct of scientifically valuable research. Methods of euthanasia and justification for selected methods, if NOT consistent with the American Veterinary Medicine Association (AVMA) Guidelines for the Euthanasia of Animals, is also required but is found in a separate section of the application. For additional information on review of the Vertebrate Animals Section, please refer to the Worksheet for Review of the Vertebrate Animals 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 Renewal applications, the committee will consider the progress made in the last funding period. In addition, please note the following:

• Administrative Core: To what extent 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 and evidence that transfer of findings has occurred?  To what extent did the applicant demonstrate effective communication with other SRP Centers and SRP staff and to broad and targeted audiences?
• Administrative Core: If the Center supports clinical trial research experience for the Trainees, to what extent 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 Center for Scientific Review (CSR), in accordance with NIH peer review policies and practices, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications will receive a written critique.

Applications may undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.

Requests for reconsideration of initial peer review of initial peer review will not be accepted for applications submitted in response to this NOFO.

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 NOFO. 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.

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 Section 2.5.1. Just-in-Time Procedures. This request is not a Notice of Award nor should it be construed to be an indicator of possible funding.

Prior to making an award, NIH reviews an applicant’s federal award history in SAM.gov to ensure sound business practices. An applicant can review and comment on any information in the Responsibility/Qualification records available in SAM.gov.  NIH will consider any comments by the applicant in the Responsibility/Qualification records in SAM.gov to ascertain the applicant’s integrity, business ethics, and performance record of managing Federal awards per 2 CFR Part 200.206 “Federal awarding agency review of risk posed by applicants.”  This provision will apply to all NIH grants and cooperative agreements except fellowships.

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access their 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 2.4.4 Disposition of Applications.

Section VI. Award Administration Information

1. Award Notices

A Notice of Award (NoA) is the official authorizing document notifying the applicant that an award has been made and that funds may be requested from the designated HHS payment system or office. The NoA is signed by the Grants Management Officer and emailed to the recipient’s business official.

In accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Any pre-award costs incurred before receipt of the NoA are at the applicant's own risk.  For more information on the Notice of Award, please refer to the NIH Grants Policy Statement Section 5. The Notice of Award and NIH Grants & Funding website, see Award Process.

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: Recipient organizations must ensure that all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

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

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

2. Administrative and National Policy Requirements

The following Federal wide and HHS-specific policy requirements apply to awards funded through NIH:

• The rules listed at 2 CFR Part 200, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards.
• All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the terms and conditions in the Notice of Award (NoA). The NoA includes the requirements of this NOFO. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities.

All federal statutes and regulations relevant to federal financial assistance, including those highlighted in NIH Grants Policy Statement Section 4 Public Policy Requirements, Objectives and Other Appropriation Mandates.

By applying for or accepting federal funds from HHS, recipients certify compliance with all federal antidiscrimination laws and these requirements and that complying with those laws is a material condition of receiving federal funding streams. Recipients are responsible for ensuring subrecipients, contractors, and partners also comply.

Applicants and recipients are strongly encouraged to refer to the NIH Director’s Statement of Priorities, entitled “Advancing NIH’s Mission Through a Unified Strategy.” 

Recipients are responsible for ensuring that their activities comply with all applicable federal regulations. Pursuant to 2 CFR 200.340, by accepting an NIH award, the recipient agrees that continued funding for the award is contingent upon the availability of appropriated funds, recipient satisfactory performance, compliance with the Terms and Conditions of the award, and may also otherwise be terminated, to the extent authorized by law, if the agency determines that the award no longer effectuates the program goals or agency priorities, in line with 2 CFR 200.340(a)(4).

Pursuant to the Cybersecurity Act of 2015, Div. N, § 405, Pub. Law 114-113, 6 USC § 1533(d), the HHS Secretary has established a common set of voluntary, consensus-based, and industry-led guidelines, best practices, methodologies, procedures, and processes.

Successful recipients under this NOFO agree that:

When recipients, subrecipients, or third-party entities have:

• ongoing and consistent access to HHS owned or operated information or operational technology systems; and
• receive, maintain, transmit, store, access, exchange, process, or utilize personal identifiable information (PII) or personal health information (PHI) obtained from the awarding HHS agency for the purposes of executing the award.

Cybersecurity plans and procedures must at minimum include the following:

• Develop cybersecurity plans and procedures, modeled after the NIST Cybersecurity framework, to protect HHS systems and data:
  • Identify:
    • Develop an inventory of all assets and accounts with access to HHS owned and operated information or operational technology systems or which obtain PII or PHI for the purposes of the award.
  • Protect:
    • Limit access to HHS owned and operated systems to only those in need of access to complete reward activities.
    • Require all staff to complete annual cybersecurity and privacy awareness training. Visit 405(d): Knowledge on Demand (hhs.gov) to obtain free trainings, if needed.
    • Enable multifactor authentication for all employees, subrecipients, and third-party entities to access HHS owned and operated information or operational technology systems.
    • Regularly backup sensitive data and test backups.
  • Detect:
    • Install anti-virus or anti-malware software on all devices, servers, and accounts used to connect to HHS owned and operated systems.
  • Respond:
    • Develop an incident response plan. See Incident-Response-Plan-Basics_508c.pdf (cisa.gov) to learn about developing incident response plans.
    • Have cybersecurity incident reporting procedures that ensure the relevant HHS awarding agencies are notified of a cybersecurity incident within 48 hours of discovery. A cybersecurity incident is defined as an unplanned interruption to a technology service or reduction in the quality of a technology service, or an occurrence that actually or potentially jeopardizes the confidentiality, integrity, or availability of an information system or the information the system processes, stores, or transmits.
  • Recover:
    • Investigate incidents and plug any security gaps identified. 

All activities proposed in your application and budget narrative must align with applicable law, including but not limited to statutes, executive orders, federal regulations and applicable judicial holdings.  Accordingly, discretionary awards shall not be used to fund, promote, encourage, subsidize, or facilitate; racial preferences or other forms of racial discrimination by the recipient, including activities where race or intentional proxies for race will be used as a selection criterion for employment or program participation; denial by the recipient of the sex binary in humans, or the belief that sex is a chosen or mutable characteristic; illegal immigration; or any other initiatives that compromise public safety.  If an application does not align, the application will not receive funding to the extent permitted by law and applicable court orders.

For applications involving substance abuse, the application must not support harm reduction. Please see Updated Funding Guidance for Recipients on Supplies and Services.

As of October 1, 2025, HHS has adopted 2 CFR Part 200, with some modifications included in 2 CFR Part 300. These regulations replace those in 45 CFR Part 75. However, for NIH, under the Consolidated Appropriations Act for FY 2026, (P.L. 119-75, Division B, Title II, Sec. 224), the provisions relating to indirect costs in 45 CFR 75 continue to apply to NIH awards. Consistent with the statute, NIH will not apply updated thresholds outlined within 2 CFR Part 200, at this time.

Not Applicable

3. Data Management and Sharing

A Data Management and Sharing Plan (DMS Plan) is required for any NIH-funded or conducted research that will generate scientific data. Applicants must submit the DMS Plan at the time of application using the NIH DMS Plan Format Page. The DMS Plan must address the elements in the structured format should not exceed two (2) pages. Where the DMS Plan Format Page requires a “Yes or No” response, no additional narrative is allowed. The Data Management and Sharing (DMS) Plan must be provided in the Overall component.

• When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement Section 8.4.1 Reporting. To learn more about post-award monitoring and reporting, see the NIH Grants & Funding website, see Post-Award Monitoring and Reporting.

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 Section 8.6 Closeout. NIH NOFOs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 2 CFR Part 200.301.

Section VII. Agency Contacts

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

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

Grants.gov Support Center - Questions regarding Grants.gov registration and services (e.g., Workspace, subscriptions).

NOFO.information@niehs.nih.gov

Center for Scientific Review (CSR)
Email: NOFOReviewContact@csr.nih.gov

NOFO.information@niehs.nih.gov

Section VIII. Other Information

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

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 2 CFR Part 200.

In addition, awards are made under the authorization of the Superfund Amendments and Reauthorization Act of 1986, 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); 42 USC 9660(a).