Department of Health and Human Services


Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute of Environmental Health Sciences (NIEHS)

Funding Opportunity Title

Biogeochemical Interactions Affecting Bioavailability for in situ Remediation of Hazardous Substances (R01)

Activity Code

R01 Research Project Grant

Announcement Type

New

Related Notices

  • September 19, 2013 - See Notice NOT-ES-13-011. Notice to Clarify Foreign Component Eligibility.
  • September 4, 2013 - See Notice NOT-ES-13-010. Notice to Clarify Placement of the Research Translation Plan.
  • August 21, 2013: Removed reference to ASSIST in section IV.3, since ASSIST is currently only available for multi-project applications.
  • July 26, 2013 - See Notice NOT-ES-13-009. Notice Announcing Informational Webinar and Webpage.

Funding Opportunity Announcement (FOA) Number

RFA-ES-13-010

Companion Funding Opportunity

Not Applicable

Number of Applications

See Section III. 3. Additional Information on Eligibility.

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

93.143

Funding Opportunity Purpose

Contaminants in the environment are affected by complex biological, geological and chemical processes that have implications for both remediation effectiveness as well as exposure risk to humans.  By understanding the mechanisms of these complex interactions, we are better equipped to optimize remediation strategies and, therefore, improve science-based decision making for site management, priority-setting, and remedy selection.  This funding opportunity announcement (FOA) will support problem-solving research on the mechanisms of biogeochemical interactions affecting bioavailability in the context of in situ remediation of contaminated soil, sediment, surface water, or groundwater.   

Key Dates
Posted Date

July 24, 2013

Open Date (Earliest Submission Date)

October 1, 2013

Letter of Intent Due Date(s)

October 1, 2013

Application Due Date(s)

November 1, 2013, 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.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

March 2014

Advisory Council Review

May 2014

Earliest Start Date

July 2014

Expiration Date

November 2, 2013

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

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

Table of Contents

Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Part 2. Full Text of Announcement


Section I. Funding Opportunity Description


Background

The mission of the National Institute of Environmental Health Sciences (NIEHS) is to discover how the environment affects people in order to promote healthier lives. The NIEHS Superfund Research Program (SRP) (http://www.niehs.nih.gov/research/supported/srp/)

was established under the Superfund Amendment Reauthorization Act (SARA) Section 311(a), which authorizes NIEHS to implement a university-based program of basic research 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.

In keeping with the broad research themes of the program mandates, the SRP endorses an interdisciplinary approach to understanding risks and developing solutions for the safe management of hazardous substances with the ultimate goal of improving public health.  The 2010 SRP Strategic Plan places a high value on problem-solving mechanistic research relevant to Nation's Superfund program, largely managed by the US Environmental Protection Agency and the Agency for Toxic Substances and Disease Registry (ATSDR). This Funding Opportunity Announcement (FOA) focuses on mechanistic research that will advance effectiveness of "in situ" remediation, meaning treating contamination in place and on site.  Research funded under this FOA is intended to be broadly applicable and not site-specific.  Consequently, research funded through this FOA is expected to provide fundamental science to inform the risk assessment and remediation management processes for Superfund or other sites impacted by hazardous substances.

Purpose

Sites impacted by hazardous substances often involve complex geological settings, interactions between the contaminants and the chemical properties of the natural environment, and interfacing with living systems (microbiological, vegetative growth, etc.).  Each of these processes - biological, geological, and chemical - can influence the fate and transport of environmental contaminants and therefore may alter human exposure risk.  Therefore, remediation success is limited by biogeochemical properties of the contaminated site and may cease to be effective if optimal conditions are not met. For example, mining has created vast tracts of land impacted by mixed metals dissolved in solutions of varying chemical composition found in complex geological settings.  Hence, remediation efforts to stabilize metals must account for the interactions between metals, microorganisms, vegetative growth, and the buffering capacity of the matrix as well as the metal speciation, source, and particle size.  All of these factors may have critical implications for human bioaccessibility (potential for a substance to be absorbed within the human body). 

For instance, the state-of-the-science regarding currently used remediation techniques in aquatic environments and their effects on levels of mercury in fish tissue is incomplete. Understanding the key mechanisms linking source loads, methylation, and bioaccumulation to guide future remediation decisions at mercury sites is necessary in order to protect harmful human exposures through bioaccumulation and fish consumption.  Similarly, assessing vapor intrusion threats in buildings overlying groundwater contaminated with chlorinated solvents, such as trichloroethylene (TCE), is challenging due to difficulties predicting ambient volatilization rates in the context of complex and dynamic subsurface interactions between and among the geological matrix (e.g. profile, structure, and composition), chemical mixture composition (e.g. dense nonaqueous phase liquids (DNAPL) versus light nonaqueous phase liquids (LNAPL), and the survival of specific microbial populations expressing particular genes that degrade chlorinated compounds.  In these scenarios, exposure and toxicity threats are greatly affected by these biogeochemical interacting factors as well as the groundwater status and fate (e.g. surface water recharge or drinking water well presence).

Another critical impetus for understanding biogeochemical interactions is to ensure long-term success of combined remediation approaches. This is particularly true for in situ chemical remediation technologies followed by bioremediation applications for clean-up of various hazardous substances.  Hence, extrapolation of risk and the development of successful exposure prevention strategies (e.g., through remediation activities) depend on understanding the biological, geological and chemical factors that influence movement of contaminants through environmental media, as well as the processes that mediate human exposures. 

This FOA will support problem-solving mechanistic research to elucidate key biological, geological, and chemical mechanisms and interactions that determine the relative bioavailability or toxicity threat levels and thereby allow more reliable remediation efforts to be conducted.  By understanding the mechanisms of these complex interactions, we are better equipped to establish science-based decision making for site management, priority-setting, and remedy selection.  The anticipated outcomes of the research funded under this FOA are to utilize mechanistic knowledge to understand how biogeochemical processes influence remediation effectiveness and, consequently, to identify which biogeochemical processes drive the availability of hazardous substances to living systems. Ultimately, the goal is to bring new solutions for site remediation and to enhance effective decision-making for Superfund-related exposure scenarios.  The intent of this FOA is to generate findings to introduce new and improved approaches to reduce exposures to hazardous substances and thereby reduce the burden of disease in humans.

Scope of Research

Applicants should propose research on critical biogeochemical interactions affecting bioavailability and in situ remediation effectiveness as related to hazardous substances in soils, sediments, surface water, or groundwater.  In response to this FOA, applicants are encouraged to form interdisciplinary teams to adequately address the in situ environment (i.e. relevant biological, geological, and chemical conditions).  In addition to technical expertise, it may be appropriate to include, within the research team, real-world expertise through involvement of in situ remediation and risk assessment practitioners to enhance the relevance of the research and provide assistance in its application.  Teams should target fundamental research areas that may include, but would not be limited to:

SRP encourages applicants to highlight the innovative aspects of their applications.  The use of innovative approaches or methodologies to provide new insight into the biological, geological, and chemical processes that alter contaminant bioavailability and affect remediation outcomes is highly encouraged.  For example, technologies that utilize imaging, advanced analytical techniques, stable isotope assays, innovative bioavailability assays, environmental molecular diagnostics, (etc.) to assess and model biogeochemical interactions may provide new understanding to achieve the goals of this FOA. In addition, SRP welcomes innovation in terms of advancing cutting-edge remediation technologies by ascertaining the mechanisms of biogeochemical interactions that maximize the effectiveness of the technology.  In particular, SRP encourages the development of sustainable, innovative “green technologies” for remediation that offer improved energy/resource-efficiency and reduce waste generation relative to other remediation technologies.  Lastly, SRP encourages innovative approaches to technology development through trans-disciplinary research (synthesis and extension of disciplinary boundaries) as well as utilizing cutting-edge research tools.   

SRP encourages applicants to propose problem-solving mechanistic research, meaning that researchers have a clear intended real-world application(s) for their studies. In particular, teams should consider opportunities for their research to inform issues related to human health risk and remediation of hazardous substances.  It is anticipated that the outcomes of the research funded in this FOA would be directly applicable for informing policy on the safe and effective containment of hazardous substances; for developing guidance to use innovative technologies for remediation; or for developing exposure prevention and remediation management strategies for sites; for informing policy related to incorporating bioavailability into risk assessment, etc.  Accordingly, applicants are encouraged to delineate a plan for "research translation", i.e. communicating and facilitating the application of research accomplishments to end-users.  For this FOA, end-users are likely to include federal government agencies, state/local government agencies, non-government organizations (NGOs), commercial sector, and/or impacted communities, etc.  SRP recommends applicants plan to engage end-users during the early stages of project development and throughout the duration of the grant, as this greatly increases the positive impact of SRP research and its utility to stakeholders.  In some cases, it may be appropriate to include end-users as part of the research team.  Applicants may include a "Research Translation Plan" (see Section IV. Application and Submission Information) where applicants describe policy or site management opportunities their mechanistic research addresses as well as the activities (planned and/or underway) to coordinate with end-users to accelerate the application of SRP research findings.  Such activities may include, but not be limited to:

As part of their application, applicants should highlight, when applicable, attributes of their in situ remediation technology that make it a significant improvement on existing technologies: sustainable/green technology (low resource use/energy use), more rapid achievement of clean-up goals, cost-effectiveness, more effective risk reduction outcomes, etc. 

Applicants are strongly encouraged, but not required, to seek opportunities for interactions at Superfund and other managed hazardous waste sites. If on-site activities will be conducted, researchers should coordinate with appropriate Federal or State site officials (e.g. remedial project managers) and must observe best safety practices. When applicable, applicants must:

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

Applicants should propose research on hazardous substances with relevance to Superfund.  Applicants should provide a clear description of how the hazardous substance(s) being studied and subsequent results are relevant to Superfund; lead to better decision making for risk assessors and remediation managers at Superfund sites.  Applicants may refer to the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) Priority List website for information on hazardous substances associated with Superfund sites (http://www.atsdr.cdc.gov/SPL/index.html). Chemical contaminants (e.g., halogenated organics, volatile organic compounds, DNAPLs/LNAPLs) and minerals (e.g., lead in soils, metal mixtures, rare earth elements) that are the drivers of risk at hazardous waste sites are also highly relevant to this FOA.

Applicants are encouraged to consult with SRP staff for specific questions about the relevancy of a hazardous substance for this FOA, particularly with regard to emerging hazardous substances.  In general, SRP is interested in emerging hazardous substances; however, applications proposing work on hazardous substances that are not yet targeted for remediation in soils, sediments, surface water, or groundwater will not be responsive to this FOA. In addition, SARA Section 101(14) excludes petroleum and natural gas for consideration as a "Hazardous Substance": http://www.niehs.nih.gov/research/supported/dert/cris/programs/srp/about/program/index.cfm.  Therefore, research on petroleum or natural gas (including hazardous substances associated with hydraulic fracturing) is not responsive to this FOA. Applications that study pharmaceuticals and personal care products (PPCP) (see: http://www.epa.gov/ppcp/) as the target hazardous substance are not responsive to this FOA.  Applications that study engineered nanoparticles/nanomaterials as a target hazardous substance are not responsive to this FOA.  However, applicants can utilize nanotechnology-based in situ remediation approaches as part of their application. Because this FOA is for in situ remediation approaches, research that focuses on dredging or excavation/removal will not be considered responsive.

Section II. Award Information
Funding Instrument

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

Application Types Allowed

New

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

The NIEHS intends to fund an estimate of 6-8 awards, corresponding to a total of $1.5M, for fiscal year 2014. Future year amounts will depend on annual appropriations.

Award Budget

Application budgets are limited to $150,000 Direct Costs per year.

Award Project Period

Applicants may request up to four years of funding.  

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

Section III. Eligibility Information


1. Eligible Applicants


Eligible Organizations

Higher Education Institutions

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

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

Foreign Institutions

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

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

Required Registrations

Applicant Organizations

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

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

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

Eligible Individuals (Program Director/Principal Investigator)

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

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

2. Cost Sharing

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

3. Additional Information on Eligibility


Number of Applications

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

NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:

Section IV. Application and Submission Information


1. Requesting an Application Package

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

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

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

Letter of Intent

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

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

The letter of intent should be sent (preferably by email) to:

Sally Eckert Tilotta, PhD
Scientific Review Officer
Scientific Review Branch
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
P.O. Box 12233; Mail drop K3-03
Research Triangle Park, NC 27709

For Courier delivery:
530 Davis Drive, Room 3076
Morrisville, NC 27560
Telephone: 919.541.1446
Fax: 301-451-5715
Email: sally.tilotta@nih.gov

Page Limitations

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

Required and Optional Components

The forms package associated with this FOA includes all applicable components, required and optional. Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate “optional” components.

Instructions for Application Submission

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424(R&R) Other Project Information

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

SF424(R&R) Senior/Key Person Profile

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

Modular or R&R Budget

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

Budgets should include funds for travel of the PD/PI and one graduate student to attend the SRP Annual Meeting.

PHS 398 Cover Page Supplement

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

PHS 398 Research Plan

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

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide  Applicants should include as part of their Data Sharing Plan, a "Research Translation Plan” as part of the Research Strategy. This research translation plan (1-paragraph minimum description recommended) should describe specific plans for translation of findings to end-users as well as any relevant and timely policy or risk assessment applications for their research.

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

Planned Enrollment Report

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

PHS 398 Cumulative Inclusion Enrollment Report

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

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications to Grants.gov, the online portal to find and apply for grants across all Federal agencies. 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.  If a Changed/Corrected application is submitted after the deadline, the application will be considered late.

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

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

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. 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.

6. Other Submission Requirements and Information

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

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

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.

Important reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.

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

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review and responsiveness by National Institute of Environmental Health Science, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.

Post-Submission Materials

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

Section V. Application Review Information


1. Criteria

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

Overall Impact

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

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? 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? 

Is the biogeochemical interaction under investigation a critical barrier to progress in the field? If successful, would the project provide data, information, and knowledge to inform the risk assessment and remediation management processes for contaminated sites?  Will the project provide a rigorous scientific basis for effective decision-making?  If the project were successful, would the findings be site-specific or broadly applicable?

Investigator(s)    

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

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?  Are the methods to assess biogeochemical interactions innovative?  Is the proposed remediation technology innovative?   

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?  Are the remediation approaches sustainable (e.g. green technology) or cost effective?  

Environment

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

Additional Review Criteria

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.

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Children 

When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the 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 five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

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

Resubmissions

Not Applicable

Renewals

Not Applicable

Revisions

Not Applicable

Additional Review Considerations

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 following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS)  Reviewers will comment on the adequacy of the Research Translation Plan.  Reviewers will consider whether the Research Translation plan adequately describes the policy or intervention opportunities their mechanistic research addresses and whether appropriate end-users are identified, and whether activities (planned and/or underway) to coordinate with end-users are likely to be effective..

Budget and Period of Support

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

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the NIEHS, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

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

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Environmental Health Sciences Council. The following will be considered in making funding decisions:

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons

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

Section VI. Award Administration Information


1. Award Notices

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

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

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

Any application awarded in response to this FOA will be subject to the DUNS, SAM Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

2. Administrative and National Policy Requirements

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

Cooperative Agreement Terms and Conditions of Award

Not Applicable

3. Reporting

When multiple years are involved, awardees will be required to submit the annual Non-Competing Progress Report (PHS 2590 or RPPR) and financial statements as required in the NIH Grants Policy Statement.

A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

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

Section VII. Agency Contacts

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

Application Submission Contacts

eRA Commons Help Desk (Questions regarding eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Web ticketing system: https://public.era.nih.gov/commonshelp
TTY: 301-451-5939
Email: commons@od.nih.gov

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

Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone: 301-435-0714
TTY: 301-451-5936
Email: GrantsInfo@nih.gov

Scientific/Research Contact(s)

Heather F. Henry, PhD
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-541-5330
Email: henryh@niehs.nih.gov 

Peer Review Contact(s)

Sally Eckert Tilotta, PhD
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-541-1446
Email: sally.tilotta@nih.gov

Financial/Grants Management Contact(s)

Lisa Archer Edwards, M.B.A.
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-541-0751
Email: archer@niehs.nih.gov

Section VIII. Other Information

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

Authority and Regulations

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.


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