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)
National Center for Research Resources (NCRR)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Funding Opportunity Title

Environmental Influences on Stem Cells in Development, Health, and Disease (R01)

Activity Code

R01 Research Project Grant

Announcement Type

New

Related Notices

Funding Opportunity Announcement (FOA) Number

RFA-ES-11-011

Companion FOA

RFA-ES-11-010, R21 Exploratory/Developmental Research Grant ward

Number of Applications

See Section III. 3. Additional Information on Eligibility.

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

93.113, 93.389

FOA Purpose

The goal of this initiative is to support novel research directions leading to understanding the potential of environmental exposures to alter function, proliferation, survival, and differentiation of stem cells, including embryonic and adult pluripotent and multipotent cells.

Key Dates
Posted Date

September 21, 2011

Open Date (Earliest Submission Date)

October 28, 2011

Letter of Intent Due Date

October 28, 2011

Application Due Date(s)

November 28, 2011, by 5:00 PM local time of applicant organization.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

March  2012

Advisory Council Review

May 2012

Earliest Start Date(s)

July 2012

Expiration Date

November 29, 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.

Table of Contents

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

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Research Objectives

The goal of this FOA is to support novel research directions leading to understanding the potential of environmental exposures to alter function, proliferation, survival, and differentiation of stem cells, including pluripotent and multipotent cells. In June 2010, the NIEHS sponsored the “Workshop on Exploring Environmental Effects on Stem Cells” composed of a panel of experts in environmental health, as well as pioneers in stem cell research to suggest novel research directions in the area. The panel produced a list of prioritized recommendations from which the current FOA is drawn.

Background

The microenvironment directs the behavior of stem and progenitor cells, the fundamental source from which all tissues derive. However, environmental health studies are lacking on stem cells. Specific exposures may trigger protective or apoptotic responses in stem cells in which case the composition and number of surviving cell populations will dictate tissue function. Alternatively, an exposure may alter stem cells in a manner that allows them to survive but results in altered developmental fate and composition of the tissues that could set the stage for disease pathogenesis. The impact of the environment is not limited to in utero exposure. While most organs are formed in the womb, many continue to develop after birth. Reproductive tissues, for example, begin a lengthy maturation process that begins with puberty. Mammary glands notably do not completely mature until pregnancy and the glands degenerate somewhat after lactation ceases, but the tissues continue to include stem and self-renewing cells. The final devolution of the mammary gland in women does not take place until menopause at about age fifty. Thus, such cells and tissues are in proliferative stages sometimes for many decades and would appear to be particularly vulnerable to insults from toxicants or environmental chemicals that can accumulate over many years. Insight is needed into the effects of chemical exposures that can potentially alter the capacity of stem cells to differentiate, function properly, and maintain genetic integrity. On the cellular and molecular levels, changes might occur to epigenetic patterns, DNA or protein adducts, or DNA mutations.

For environmental diseases, a central issue to resolve is the role of stem cells in the genesis of tumors or pre-cursors of degenerative diseases. This requires an understanding of stem and progenitor cells over the lifespan and begs an important question: do adult stem and progenitor cells behave more like somatic cells or embryonic stem cells (with respect, for example, to cell cycle regulatory mechanisms and suppression of mutations)? The mechanisms of action of exposures on stem cells across the lifespan is a key to these issues and, perhaps, to individual and population susceptibility, especially at specific developmental stages.

One direction that was highly prioritized by the Workshop on Exploring Environmental Effects on Stem Cells is investigation of stem cells that elucidate the limits of Windows of Susceptibility (WOS), the concept that individuals are more at risk from exposure at certain points in the lifelong developmental timeline. There is compelling evidence for WOS, for example, from studies of female survivors of the Hiroshima atom bomb who were much more likely to develop breast cancer as adults if they were in pre-pubertal or pubertal periods at the time of the explosion. WOS periods likely exist in both genders and may include in utero, puberty, pregnancy, and menopause, all periods in which stem cells exist and are likely targets for hormonal imbalance and hormone-mimicking substances. Novel studies are needed to address exposures and mechanisms by which stem cell fate and function may become altered and the subsequent role in WOS: why WOS exists, its limits, and the pathways by which environmental chemical exposures might initiate cells and tissues for disorders. Studies of exposure – response in stem cells would be expected to lead to improved definition and understanding of WOS. However, investigations have rarely explored this relationship with regard to fate and lineage, population composition, tissue morphology, epigenetics, or DNA repair. These parameters need to be illuminated in order to produce a comprehensive model of the role of stem cells in WOS that will translate into improved understanding of disease risk over the lifespan of an individual.

Also of interest is the role of the environment on cellular re-programming. Reports on laboratory animals indicate that differentiated cells removed from one organ, such as testicular or neural cells, can de-differentiate and re-program into other cell types when implanted into a different tissue, such as mammary gland. Importantly, investigators are able to manipulate these processes – including cell fate, state, and function - using small molecules to target specific signaling pathways. These recent discoveries provide a new opportunity to investigate the fundamental molecular and genetic properties of stem cells. The physiologic consequences of re-programming are unclear, but could provide significant insights into pathogenesis or resistance to disease, as well as into fundamental steps in development, maturation, and aging. Understanding of the biology of re-programmed cells remains limited and additional research is needed to fully understand the role of these events in pathophysiology. Studies are needed on the sequence of molecular events and mechanisms of reprogramming in response to environmental insults. In particular, improved understanding is needed of the epigenetics of the differentiated cells of interest versus proliferative and re-programmed states under native as compared with chemically challenged conditions.

Pluripotent stem cells contain the genetic background of the individual from which they were originally derived. Interaction between genetic background and exposures to environmental stimuli and understanding the mechanisms through which environmental exposure interact with susceptibility genes are critical to disease prevention using stem cell based technologies. Use of animal models, such as genetically modified mice, has provided important insights for understanding human disease etiologies because genetic background and environmental exposures can be controlled. Pluripotent cells and animal models therefore may be useful for understanding the genetic and environmental factors that contribute to individual responses, particularly when combined with genetic and bio-monitoring studies that are being used to estimate exposure levels to environmental chemicals.

Specific Areas of Interest

Support through this FOA is limited to projects concerning the endocrine, reproductive, immune / hematopoietic, and central nervous system as they relate to environmental health and disease. For the purposes of this FOA, environmental exposures refer to chemical and physical agents found in the environment  such as  chemicals, dietary contaminants, or hormone - mimicking substances (such as endocrine disruptors) to which people are commonly in contact. Therapeutic drugs are not considered an environmental exposure. While studies of the role of early exposure of stem cells leading to tumorigenesis are an appropriate response to this FOA, studies of immortalized cells or tumor cells, themselves, are not acceptable as the focus of an application. Applications may include adult human stem cells, comparative studies of embryos or embryonic stem cells in mammalian models, or human embryonic stem cell (hESC) lines that are approved for NIH funding as indicated in the NIH Human Embryonic Stem Cell Registry (http://grants.nih.gov/stem_cells/registry/current.htm). Applications to use hESC lines that are “on hold” will not be considered for support unless the hESC line is fully approved at the time of funding.

Supported investigations are expected to provide insights into how stem cells respond to environmental chemical changes that may lead to altered cell function, fate, or changes to compositions of cell populations that could predispose towards disease, either in the short-term or following extended periods of latency. Alteration to the stem cell populations and their progeny likely sets the stage for tissues that become either pre-disposed or resistant to disease.

Characterization of stem cells often depends critically on the use of animal models. Stem cell biologists face significant challenges in studying stem cells in vivo and a variety of animal models are capable of serving as sources and recipients of their own immature and differentiated cells as well as host systems for xenotypic transplantation of human stem cells. These studies are currently performed predominantly with mice but should include animals with longer life spans and species representing different evolutionary clades. In particular, nonhuman primates (NHP), due to their genetic proximity to humans, could contribute significantly to the field of stem cell biology.

Responsive Applications

Applications need to demonstrate that appropriate expertise is available in the use of stem cells and must document that model system(s), bio-samples, or cell lines are in hand or advanced development. Applicants intending to develop models or to initiate new environmental health studies using stem cells might consider applying for the companion RFA-ES-11-010 (R21 Exploratory / Developmental Research Grant Award) that supports studies to develop models and accumulate preliminary data leading to application for an R01.

Studies that address topics such as the following would be responsive to this FOA. The following examples are not intended to be exhaustive and other environmental health applications may be considered responsive.

Elucidation of the role of stem cells in mechanisms of Windows of Susceptibility in, for example, mammary glands. Aims could include determination of the effects of common environmental exposures such as endocrine disruptors on the timing and other parameters of the “window.”

Determination of the exposure - modifiable characteristics of precursor cells for neurons or glial cells explain different sensitivity of children and adults to pesticides such as chlorpyrifos. Studies could focus on the population distribution of cell receptors or their isoforms or delve into the downstream pathways that mediate toxicity.

Investigation of cellular profiles (e.g. gene expression, epigenetic or proteomic phenotype) that determine lineage and eventual fate and that are altered by specific environmental influences / exposures that might play a role in eventual disease initiation, onset, or progression.

Clarification of the genotoxic or non-genotoxic mechanisms of environmental agents in altering stem cell differentiation and lineage, proliferation, and eventual population composition. Aims could address fundamental qualities of stem cells such as their DNA repair capacity relative to terminally differentiated cells and how the failure of DNA repair following exposure results in altered fate, function, etc.

Study of environmental influence on the molecular events underlying cell re-programming. Aims could address how such events underlie cell initiation for disease susceptibility and eventual progression to environmental cancer or other environmental diseases.

Study of neurotoxins, pesticides, phthalates, or arsenic on the cell distribution among stem cells populations that might contribute to chemical sensitivity or pre-dispose one to disorders of the endocrine, reproductive, immune, or central nervous systems.

NIEHS does not intend to support through this FOA development or use of stem cells or stem cell lines as tools for toxicological screening or to develop procedures to expand cultures of stem cells in vitro.

Applications whose main propose is to develop or refine methods to derive induced pluripotent stem cells (iPSC) or specific differentiated lineages from iPSC or hESC will not be considered responsive.

For the purpose of this FOA, the NCRR will accept only those applications that involve investigations using animal stem cells, either alone or in comparison to human stem cells. The NCRR will accept only those applications, the subject of which relates to the interests of two or more of the categorical NIH Institutes and Centers.  Furthermore, the NCRR will not accept applications that are related principally to the interest of one of the NIH categorical ICs and only peripherally to the interests of other ICs. Interests of the NCRR in environmental influences on animal stem cells include, but are not limited to the following:

Understanding the major molecular mechanisms affected by environmental exposures, including similarities and differences between animal and human stem cells.

Addressing major challenges in the use of animal models to study human stem cell biology. e.g., – experimental standardization, body size, immunological barriers, cell survival factors etc.  How problems posed by these challenges can be solved to provide critical information for understanding the effects of environmental exposures on behavior of precursor and differentiated cell in vivo.

Improving technologies related to use of animal stem cells, including cell culture assays, and high-throughput screens to establish standardized and efficient rodent and other animal universal bioassays that can be used to test and characterize the adverse effects of environmental exposures on stem cells.

Section II. Award Information
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

 NIH intends to commit approximately $2.5 million in FY 2012 to this FOA to support 7 - 8 awards.

Award Budget

Application budgets are not limited, but need to reflect actual needs of the proposed project.

Award Project Period

The total project period for an application submitted in response to this funding opportunity may not exceed 5 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.

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:

Nonprofits Other Than Institutions of Higher Education

For-Profit Organizations

Governments

Other

Foreign Institutions

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

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

Required Registrations

Applicant organizations 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.

All Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) 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.

Eligible Individuals (Program Director(s)/Principal Investigator(s))

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(s)/Principal Investigator(s) Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF 424 (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 in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed.

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 to:

Terry Nesbitt, Ph.D.
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 27713
Email:  nesbitt@niehs.nih.gov
Phone:  (919) 541-7571
Fax: (919) 541-2503

For Courier, mail to:

NIEHS
530 Davis Drive
Keystone Building, Third Floor, Room 3082
Research Triangle Park, NC 27713  

Required and Optional Components

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 submission of applications for this FOA. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate “optional” components.

Page Limitations

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

PHS 398 Research Plan Component

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, with the following modification:

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 Institutions

Foreign (non-US) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout 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 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.

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 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(s)/PI(s) 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(s)/PI(s) 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 the National Institute of Environmental Health Sciences, 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 nesbitt@niehs.nih.gov when the application has been submitted.  Please include the FOA number and title, PD(s)/PI(s) name, and title of the application.

Post Submission Materials

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

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.

As the establishment of stem cell lines and technologies is not trivial, the applicants are requested to document the availability of the model system or cells or the plans to develop novel experimental cell systems. The model system, cell line, and/or primary cells should be described in sufficient detail to allow determination of the suitability of the cells to the proposed aims and hypothesis.

Overall Impact

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).

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?  

Investigator(s)    

Are the PD(s)/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(s)/PI(s), do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? The reviewers will evaluate the expertise of the applicants in using stem cells and tissues of interest and whether appropriate expertise is appropriate in using stem cells, culture techniques, and/or establishment of the proposed cells or model systems.  

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?        

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/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

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/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.

2. Review and Selection Process

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

As part of the scientific peer review, all applications:

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   and the Advisory Research Resources Councill. 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, CCR 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 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 the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in theNIH 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

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 301-435-0714
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

Scientific/Research Contact(s)

Leslie Reinlib, PhD
Division of Extramural Research & Training
National Institute of Environmental Health Sciences (NIEHS)
Telephone:  (919) 541-4998
Email:  reinlib@niehs.nih.gov  

Oleg Mirochnitchenko, PhD
Division of Comparative Medicine
National Center for Research Resources (NCRR)
Telephone:  (301) 435-0744
Email:  oleg.mirochnitchenko@nih.gov         

Peer Review Contact(s)

Terry Nesbitt, Ph.D.
Division of Extramural Research and Training
National Institute of Environmental Health Sciences (NIEHS)
Telephone:   (919) 541-7571
Email:   nesbitt@niehs.nih.gov

Financial/Grants Management Contact(s)

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

Irene M Haas
Director, Office of Grants Management
National Center for Research Resources (NCRR)
Telephone:  (301) 435-0836
Email:  grissomi@mail.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.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


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