Participating Organization(s)	National Institutes of Health (NIH)
Components of Participating Organizations	National Institute of Environmental Health Sciences (NIEHS) National Cancer Institute (NCI)
Funding Opportunity Title	Dietary Influence on the Human Health Effects of Environmental Exposures (R21)
Activity Code	R21 Exploratory/Developmental Research Grant Award
Announcement Type	New
Related Notices	April 19, 2011 - See Notice NOT-ES-11-008 The purpose of this notice is to inform the scientific community that the Scientific Merit Review, Advisory Council Review, and Earliest Start Dates have been changed. February 9, 2011 - See Notice NOT-CA-11-007 This Notice is to inform potential applicants that the National Cancer Institute (NCI) will participate in this RFA.
Funding Opportunity Announcement (FOA) Number	RFA-ES-11-002
Companion FOA	None
Number of Applications	See Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestics Assistance (CFDA) Number(s)	93.113, 93.393
FOA Purpose	This FOA, issued by National Institute of Environmental Health Sciences (NIEHS), National Institutes of Health (NIH), solicits grant applications from institutions/organizations to develop and test plausible hypotheses that relate dietary factors to the development or progression of toxicant-induced diseases. The ultimate goal of this research program is to produce new research findings that will expand our understanding of how environmental toxicants and diet/nutrition interact to influence human health and enable the development of effective primary prevention and intervention strategies to mitigate environmentally-induced diseases.

Posted Date	January 20, 2011
Open Date (Earliest Submission Date)	March 21, 2011
Letter of Intent Due Date	March 21, 2011
Application Due Date(s)	April 21, 2011, by 5:00 PM local time of applicant organization.
AIDS Application Due Date(s)	Not Applicable
Scientific Merit Review	(New Date October 2011 per NOT-ES-11-008), Original Date: July 2011
Advisory Council Review	(New Date January 2012 per NOT-ES-11-008), Original Date: October 2011
Earliest Start Date(s)	(New Date April 2012 per NOT-ES-11-008), Original Date: December 2011
Expiration Date	April 22, 2011
Due Dates for E.O. 12372	Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF 424 (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.

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

Research conducted over the past several decades indicates clearly that disease risk is multifactorial, influenced by diverse elements that include exposure to environmental agents, diet/nutrition, and genetic susceptibility. From a pathophysiological standpoint, many environmental exposures affect common biological pathways that are linked to disease, such as oxidative stress and inflammation; these same pathways are likely to be influenced by diet and nutritional status. Thus, variability in disease risk in response to environmental exposures within populations may be at least partially attributable to unmeasured variation in nutritional status and/or other components of the diet.

This FOA is intended to support research projects aimed at (1) more clearly identifying those dietary components that influence the trajectory or onset of environmentally-linked disease and (2) increasing our understanding of the mechanisms underlying the interplay between diet/nutrition and exposure to environmental agents and disease risk. It is anticipated that the results of the studies supported under this FOA will be used to identify and inform intervention or prevention strategies to help mitigate the harmful effects of environmental exposures.

Recent evidence from epidemiological and basic research studies suggests that disease onset and trajectory can be influenced both positively and negatively by the interplay between dietary factors and environmental exposures. For example, poor diets related to low consumption of antioxidants and or high consumption of dietary fat and sugar have been shown to increase the negative effects of polluted air we breathe on asthma symptoms. These risks have been shown to be ameliorated with proper supplementation of antioxidants or by vitamin D supplementation. The effects of fish consumption on health outcomes provides another instructive example of the complex relation between toxicants and diet/nutrition. It has long been known that pregnancy outcomes are related to maternal nutrition, and that fish consumption during pregnancy is generally associated with positive effects on birth outcomes and children’s neurodevelopment. The robustness of these beneficial effects are underscored by data demonstrating that they occur even under conditions where fish consumption is a source of exposure to harmful contaminants such as mercury and persistent organochlorine pollutants (POPs). A leading hypothesis to explain this protective effect despite potential increased exposure to harmful toxicants is that fish are also rich in Omega-3 fatty acids, which have been shown to reduce the harmful effects of maternal mercury-contaminated fish consumption on child cognitive and behavioral performances. Other studies have shown that fish consumption during the last trimester mitigates the harmful developmental effects of prenatal exposure to fine air particulate matter. These examples highlight the importance of diet-toxicant interactions in modulating disease risk.

Genetic variation represents another important facet of the diet-toxicant-disease paradigm. A growing number of studies support the concept of genetic susceptibility to the effects of environmental exposures. The most straightforward examples are those where the risk of an environmentally linked disease is associated with genetic variation in the metabolism of toxicants. In other cases, the effects of environmental exposures and genetic variation converge on common biologic pathways and act synergistically to influence disease risk. Likewise, in the area of nutrition, studies are beginning to explore the joint effects of genes and diet on various health outcomes, including diabetes and obesity. Recent findings in the area of epigenetics and epigenomics provide intriguing examples by which environmental chemicals and nutrition can influence gene expression through epigenetic mechanisms.

Adding another layer of complexity to the diet-toxicant-disease paradigm is the role of anthropometric attributes in influencing these relationships. For example, environmental chemicals in the diet or other sources may contribute to obesity through their perturbation of biologic pathways linked to endocrine signaling. Regardless of whether obesity originates from exposure to endocrine-active compounds and/or from a high fat diet, the changes in endocrine and other signaling pathways that accompany obesity may themselves provide a biologic substrate that alters susceptibility to the same or to different environmental exposures. In this manner, obesity can be viewed not only as an outcome of interest linked directly to exposure and/or nutrition, but also as a mediator of the effects of exposure(s) on other disease endpoints.

Studies in model systems are also underway to explore mechanisms underlying the effects of diet and nutrition on biological pathways affected by environmental toxicants. The conservation of model organism genomes and physiological characteristics allows exploration in an in vivo setting where the dietary and/or environmental exposure variables can be accurately controlled. Transgenic models have provided useful tools for dissecting gene by environment and gene by nutrition interactions. A large body of relevant research exists in the disease areas of carcinogenesis and obesity. For example, multiple studies have used targeted disruption or overexpression of specific genes in mice to understand how genetic variation can alter the effects of a high fat diet on obesity and related conditions. Other studies have used animal models to investigate the association of dietary total fat with mammary cancer and to identify genetic modifiers of this association. In light of the well-established role of oxidative stress in the pathobiology of many diseases, many studies have focused on pro and antioxidant properties of various nutritional components, where animal and cellular models have provided an important tool for development and testing antioxidant prevention and intervention strategies. In the area of epigenomics, seminal studies in animals have demonstrated that exposure to folate and other methyl donors supplementation during pregnancy exert profound effects on multiple outcomes in the offspring and these effects are related to methylation-induced changes in the expression of specific genes. More recent data reveal that gestational exposure to the endocrine disruptor bisphenol A alters estrogen sensitivity through altered methylation of estrogen receptor promoter region.

These aforementioned examples attest to the utility of animal and cellular models for exploring environment-disease relationships or nutrition disease relationships. Fewer studies have investigated the joint effects of nutrition and chemical exposures on disease risk in the same model, although available data suggest that this is a fruitful approach. For example, the mechanism of the protective effect of selenium on arsenic-induced carcinogenesis has been investigated in animal models. Other studies in animals have been conducted to address conflicting epidemiological data regarding the role of beta carotene or lycopenes on tobacco-induced lung cancer risk. One of the most striking examples of the interplay between genes, nutrition and environmental chemicals comes from data in mice showing that bisphenol A induced hypomethylation can be counteracted by maternal supplementation with methyl donors or genestein.

Taken together, studies such as these demonstrate the plausibility of complex diet-environment-disease relationships and the potential promise of their further exploration in both human and laboratory based studies.

The main objective of supporting research in this area is to develop and test plausible hypotheses that relate dietary factors to toxicant induced disease risk. A better understanding of mechanisms underlying these complex interactions will enable the development of effective primary prevention and intervention strategies to mitigate environmentally induced diseases.

Types of research and experimental approaches encouraged through this FOA:

Human-based Studies

Epidemiology studies are encouraged that build on existing cohorts, clinical trial populations, or other population-based studies to examine the joint contribution of diet and environment on health outcomes. The development of robust study designs and analytic methods to accommodate and provide insight into such complexities that may exist in diet-toxicant-disease relationships is also encouraged.

Examples of studies that could be considered include:

• Expansion of existing studies to look at the interplay between diet (ie. dietary intake, supplement use, anthropometry) and environmental exposure on health outcomes, including secondary data analysis of previously collected data in on-going studies as well as small ancillary studies to collect new data on diet or environmental exposures.
• Feasibility studies to test or develop tools or protocols for future studies that will look at diet and environment exposures, such as the refinement of nutritional assessment for specific populations under investigation or the addition of a new environmental measure or assay to an existing nutritional study.
• Pilot studies to produce new preliminary data to support and aid in the design of future studies testing diet- environment interplay.

Laboratory-based Studies

Laboratory-based studies using animal models, in vitro cellular and molecular studies that identify and evaluate molecular targets and mechanisms underlying the interactions between diet/nutrition, environmental exposures, and disease outcomes are encouraged. Examples of studies that could be considered include:

• Identify and evaluate nutritional factors (ie. macro and micro-nutrient intake, dietary supplements, anthropometry) that modulate the health effects of environmental chemicals
• Identify critical life stages where the effects of dietary parameters will have the most pronounced effects on health outcomes.
• Use well established animal models of environmentally-induced disease to study the interaction of diet and nutrition with environmental toxicants.
• Identify key molecular targets in relevant biologic pathways that could be useful in prevention/intervention studies

Funding Instrument	Grant
Application Types Allowed	New The OER Glossary and the SF 424 (R&R) Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards	NIEHS intends to commit an estimated total of $2 million toward 10 awards.
Award Budget	Application budgets cannot exceed $150,000 per year in direct cost in any one budget year. The total direct costs allowed over the life of the grant may not exceed $300,000. The requested funds must reflect the actual needs of the proposed project.
Award Project Period	The scope of the proposed project should determine the project period. The maximum period is 3 years.

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

Higher Education Institutions:

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

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

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For profit Organizations

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Governments

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

Other

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

Non-domestic (non-U.S.) Entities (Foreign Organizations) are eligible to apply.
Foreign (non-U.S.) components of U.S. Organizations are allowed.

Applicant organizations must complete the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

• Central Contractor Registration (CCR) must maintain an active registration, to be renewed at least annually
• Grants.gov
• eRA Commons

All Program Directors/Principal Investigators (PD/PIs) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least four (4) weeks prior to the application due date.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Project Director/Principal Investigator (PD/PI) 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 SF 424 (R&R) Application Guide.

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

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

NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.

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.

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.

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

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

Descriptive title of proposed research
Name, address, and telephone number of the PD(s)/PI(s)
Names of other key personnel
Participating institutions
Number and title of this funding opportunity

The letter of intent should be sent to:

Leroy Worth, PHD
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
PO BOX 12233, MD K3-03
Research Triangle Park, NC 27709-2233
Telephone: 919-541-0670
Email: worth@niehs.nih.gov

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

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

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..

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.

Foreign Organizations

Foreign (non-US) organizations must follow policies described in the NIH Grants Policy Statement, and procedures for foreign organizations described throughout the SF424 (R&R) Application Guide.

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in advance of the deadline to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications via 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.

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

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

This initiative is not subject to intergovernmental review.

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

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

Applications must be submitted electronically following the instructions described in the SF 424 (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/PIs must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF 424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the Central Contractor Registration (CCR). 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 NIEHS, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.

In order to expedite review, applicants are requested to notify the NIEHS Referral Office by email at phelps1@niehs.nih.gov when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115..

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.

The R21 exploratory/developmental grant supports investigation of novel scientific ideas or new model systems, tools, or technologies that have the potential for significant impact on biomedical or biobehavioral research. An R21 grant application need not have extensive background material or preliminary information. Accordingly, reviewers will focus their evaluation on the conceptual framework, the level of innovation, and the potential to significantly advance our knowledge or understanding. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or, when available, from investigator-generated data. Preliminary data are not required for R21 applications; however, they may be included if available.

Reviewers will provide an overall impact/priority 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? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Investigator(s)

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

Innovation

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

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?

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

Environment

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

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact/priority 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 Human Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children

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

Vertebrate Animals

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

Biohazards

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

Resubmissions

Not Applicable.

Renewals

Not Applicable.

Revisions

Not Applicable.

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/priority score.

Applications from Foreign Organizations

Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

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).

Budget and Period of Support

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

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the National Institute of Environmental Health Sciences (assignments will be shown in the eRA Commons), in accordance with NIH peer review policy and procedures, using the stated review criteria.

As part of the scientific peer review, all applications:

• May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review), will be discussed and assigned an overall impact/priority score.
• Will receive a written critique.

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

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

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

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

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

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee 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, CCR Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

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

Cooperative Agreement Terms and Conditions of Award

Not Applicable.

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

A final progress report, invention statement, and Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.

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

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

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading or navigating forms)
Contact Center Phone: 800-518-4726
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-710-0267
TTY 301-451-5936
Email: GrantsInfo@nih.gov

eRA Commons Help Desk(Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: commons@od.nih.gov

Kimberly Ann Gray, PhD
Division of Extramural Research and Training
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-541-0293
Email: gray6@niehs.nih.gov

Leroy Worth, PhD
Division of Extramural Research and Training
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-541-0670
Email: worth@niehs.nih.gov

James Williams
Division of Extramural Research and Training
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-541-1403
Email: williamsjr@niehs.nih.gov

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

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