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

Superfund Hazardous Substance Research and Training Program (P42)

Activity Code

P42

Announcement Type

Reissue of RFA-ES-09-012

Related Notices

Funding Opportunity Announcement (FOA) Number

RFA-ES-10-010

Companion FOA

None  

Number of Applications

Only one application per accredited institution of higher education will be accepted.  Section III. 3. Additional Information on Eligibility.

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

 93.113, 93.143

FOA Purpose

The National Institute of Environmental Health Sciences (NIEHS) is announcing the continuation of the Superfund Hazardous Substance Research and Training Program [referred to as Superfund Research Program (SRP) Centers]. SRP Center grants will support problem-based, solution-oriented research Centers that consist of multiple, integrated projects representing both the biomedical and non-biomedical disciplines; as well as cores tasked with administrative, community engagement, research translation, research support, and training functions.  The scope of the SRP Centers is taken directly from the Superfund Amendments and Reauthorization Act of 1986, and include: (1) advanced techniques for the detection, assessment, and evaluation of the effect on human health of hazardous substances; (2) methods to assess the risks to human health presented by hazardous substances; (3) methods and technologies to detect hazardous substances in the environment; and (4) basic biological, chemical, and physical methods to reduce the amount and toxicity of hazardous substances.

Key Dates
Posted Date
Open Date (Earliest Submission Date)

March 15, 2011

Letter of Intent Due Date

March 16, 2011

Application Due Date(s)

April 15, 2011, by 5:00 PM local time of applicant organization.

AIDS Application Due Date(s)

N/A

Scientific Merit Review

October 2011

Advisory Council Review

January 2012

Earliest Start Date(s)

April 2012

Expiration Date

April 16, 2011

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the PHS398 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. While some links are provided, 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 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

Purpose

The National Institute of Environmental Health Sciences (NIEHS) invites qualified investigators from domestic institutions of higher education to submit an application for a Superfund Research Program (SRP) Center grant.  SRP legislation, under the Superfund Amendments and Reauthorization Act (SARA) of 1986, allows NIEHS the flexibility to create university-based Centers for conducting science to address the wide array of scientific uncertainties facing the national Superfund program.  The complex problems related to sites impacted by hazardous substances (e.g. Superfund and related sites) require the expertise of multiple biomedical and non-biomedical disciplines.  Applicants responding to this FOA are expected to design a research Center that integrates environmental health sciences with related environmental science and engineering disciplines (geochemical, ecological sciences, etc.).  The goal of the NIEHS SRP Center is to improve public health by supporting integrative, multidisciplinary research incorporating the following:

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. 

Research and supporting activities from each Center should address at least one or more of these mandates.

Applicants are encouraged to refer to the SRP’s Strategic Plan (http://tools.niehs.nih.gov/srp/about/register.cfm) which describes and defines the objectives and goals of the SRP in order to address its mandates over the next five years.  The three primary objectives of the SRP are to (1) address issues of high relevance, (2) maximize the impact of SRP investments, and (3) foster innovation. 

Scope of the SRP Center Grant

The scope of the SRP Center Grant is defined by the SRP Mandates.  Research and supporting activities under this FOA may utilize a variety of approaches to achieve SRP mandates: 

1) Health Effects Research: Advanced techniques for the detection, assessment, and evaluation of the effect of hazardous substances on human health. 

It is believed that environmental factors contribute to the etiology of most human diseases/dysfunctions (e.g., reproductive, immune competence, pulmonary/cardiovascular, cancer, neurodevelopment, neurobehavioral, congenital defects, renal, etc.).  Therefore, the SRP seeks to support mechanistic and/or mode of action research that includes laboratory-based and population-based studies for unraveling critical biological pathways that contribute to disease when perturbed by environmental contaminants.  Highly innovative approaches such as high-throughput screening techniques, “omics” approaches, tissue engineering, and in silico modeling are desired.  Also, discovery and validation of biomarkers useful for exposure assessment, indicators of biological response, and disease susceptibility are important research activities with translational opportunities for improved risk assessment.  SRP recognizes the important public health impact of research focusing on exposures to consumer product-related chemicals, non point-source air pollution, and non point-source drinking water, but a higher priority will be placed on research with a clear connection to understanding health effects relevant to populations living near or affected by sites impacted by hazardous substances.

2) Risk Assessment Research: Methods to assess the risks to human health presented by hazardous substances.

Historically, risk assessments are focused on developing models for either human health or ecological health; however, within the interdisciplinary framework of the SRP, integrated human and ecologic models may be developed to assist in making cost-effective and protective decisions.  As a component of risk, understanding the complex phenomena that impact exposure is an important research focus for the SRP.  Exposure science research of interest includes: fate, transport, and transformation of contaminants in the environment; contaminant bioavailability in the environment and in biological systems; identifying biomarkers of exposure; and quantifying body burden.  SRP also recognizes the need for developing methods to integrate exposure over time and to characterize the attributable risk from multiple exposures experienced over one’s lifetime. Cumulative risk models should be used to synthesize findings from health effects research, susceptibility, and mode of action to support more complex exposure assessments in susceptible and diverse populations (e.g. medically and economically disadvantaged).  SRP recognizes the important public health impact of research focusing on exposures to consumer product-related chemicals, non point-source air pollution, and non point-source drinking water, but a higher priority will be placed on research with a clear connection to understanding exposures relevant to populations living near or affected by sites impacted by hazardous substances. 

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

The SRP seeks to support basic and applied research on the development and application of new and advanced technologies for detection and monitoring of hazardous substances.  Site characterization can be an expensive and invasive process. The SRP seeks development of methods and devices that offer precise and low-cost readings to increase spatial density of measurements at a hazardous waste site.  This includes bioassays or ecological indicators that assess toxicity to biological systems in sites complicated by multiple contaminant streams or complex environmental media.  In addition, innovative tools that allow for real-time, on-site monitoring, are encouraged, including:  advanced sensors and probes, biosensors, new imaging modalities, self-contained miniaturized toxicity-screening kits, miniaturized analytical probes, and data analysis tools.  The SRP also seeks in situ devices that are capable of multi-analyte readings and/or determination of the degree of bioavailability of a contaminant.  Sensor research should apply to the complex media encountered at hazardous waste sites (soil, sediments, groundwater, etc.) but Centers are also encouraged to consider applications for biomonitoring, in collaboration with biomedical researchers.  Similarly, tools developed and used for site assessment may also inform predictive modeling, and these approaches should integrate the resulting environmental data within a contextual framework of how contaminants affect nearby populations - human or wildlife.  SRP also encourages researchers to consider the sustainability of monitoring tools taking into account device reuse, waste generation, and utilization of non-toxic components (particularly for in situ devices), etc. 

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

The SRP supports the application of relevant non-biomedical research (e.g. engineering, geological, and microbiological sciences) as a prevention strategy to improve human health by mitigating exposure and reducing toxicity of environmental contaminants.  SRP seeks research that is focused on the scientific principles and underlying processes that drive different remediation technologies as methods to clean up persistent toxicants in groundwater, sediments, fractured bedrock, and soils. SRP encourages the continuum of research to focus on the translation of these basic principles into feasible, efficient, and cost-effective chemical, physical, and/or biological technologies that reduce the level of contaminants present in the environment.  Combined remediation approaches are encouraged as a means to maximize the complete degradation of hazardous substances at complex sites.  SRP also encourages development of green and sustainable remediation techniques that improve energy efficiency and reduce waste generation including innovative in situ remediation approaches.  The multidisciplinary framework of SRP encourages health effects researchers to collaborate with remediation scientists to assess and mitigate unintended toxicological implications of the remediation. 

Examples of Research Topics.  As outlined or specified in the Strategic Plan, SRP seeks to improve relevance through encouraging applicants to design problem-based, solution oriented research to address needs of its primary stakeholders (e.g. Superfund-related agencies as well as the individuals and communities living near sites impacted by hazardous substances) in identifying problems.  Hence, applicants are encouraged to engage stakeholders as they develop research projects to identify critical gaps in knowledge for which basic research is needed.  Furthermore, applicants are encouraged to develop community engagement research projects to address any one of the above mandates (see "Research Projects" section below).  For a listing of research areas of interest to the SRP and its stakeholders, please refer to the “Suggested Research Topics” document on the following website (http://www.niehs.nih.gov/research/supported/srp/funding/rfa.cfm).  This webpage also contains links to specific research needs identified by sister Superfund agencies (EPA and ATSDR).

The Strategic Plan also states/requires/directs  that SRP will be proactive in achieving coverage and balance across mandate areas, contaminants, and exposure scenarios placing emphasis on stakeholders’ critical needs.  Therefore, the applicant is strongly encouraged to visit the SRP website’s “Additional Resources” page at http://www.niehs.nih.gov/research/supported/srp/funding/rfa_resources.cfm to determine how research that may be proposed fills research gaps or needs not currently addressed within the SRP (current grantees can be found at the following website: http://tools.niehs.nih.gov/srp/programs/index.cfm).

Hazardous Substances.  SRP Centers present a unique opportunity to address research needs of existing Superfund sites; hence, research on chemical contaminants (such as trichloroethylene) and minerals (such as asbestos or mine tailings) that are the drivers of risk at hazardous waste sites are highly relevant to SRP.  These include:

The applicant should refer to the following CERCLA Priority List website for information on hazardous substances that are relevant to the US Environmental Protection Agency (EPA) Superfund program and to the Agency for Toxic Substances and Disease Registry (ATSDR): (http://www.atsdr.cdc.gov/cercla). 

There are a number of contaminants that are of emerging concern to Superfund.  These substances include, but are not limited to:

SRP recognizes the important role of proactive research on emerging contaminants.  Applicants wishing to focus on these compounds should clearly describe how results gained from the studies are relevant to Superfund.  They should also indicate how these studies will lead to better decision making for risk assessors and remediation managers at Superfund sites and/or addressing uncertainties involved in understanding disease/dysfunction for communities impacted by hazardous substances. 

Activities on Hazardous Waste Sites.  Whether through project research or core activity, Centers are strongly encouraged to utilize opportunities for interactions at Superfund and other managed hazardous waste sites.  If on-site activities will be conducted, researchers must coordinate with appropriate federal or state site officials and must observe best safety practices.  When applicable, applicants must:

In addition, engagement of site officials in the early stages of project development and throughout the process is recommended, as this greatly increases the positive impact of SRP research and its utility to stakeholders.  

Center Components

Research Projects (Required): 

The SRP requires a minimum of two biomedical and two non-biomedical research projects.  The biomedical research projects should address biomedical or human health-related implications of hazardous substances.  This includes but is not limited to: mechanistic-based toxicology studies, epidemiology, human risk assessment, genetic susceptibility, computational toxicology, or biomedical engineering.  The non-biomedical research projects should address environmental science or engineering implications of hazardous substances.  These projects are integral to the protection of human health through predicting, detecting, and preventing exposures.  Non-biomedical research projects include but would not be limited to: civil/environmental engineering, geology, ecology, microbiology, fate and transport studies, hydrogeology, remediation and detection sciences.  Research should emphasize a balance of basic and applied research that contributes to the problem-based, solution-oriented goal of the Center.  The collection of projects should, therefore, bring together biomedical and non-biomedical expertise necessary to address the central problem and to orient research such that the Center findings provide a clear step towards identifying solutions to these problems.  Projects should be hypothesis-driven or product-oriented research. 

The SRP Strategic Plan emphasizes the importance of investigator-initiated research translation as a means to achieve SRP impact.  Researchers should, therefore, coordinate with the Research Translation Core to identify an appropriate plan to facilitate translation of the research project outcomes to potential end-users. 

As described in the SRP Strategic Plan, it is important that applicants prioritize and address the most critical research areas to maximize relevancy of SRP.  Maximizing relevancy requires that all SRP mandate areas (health effects, risk, detection and remediation) are covered, and the most critical current and emerging needs are addressed. When preparing applications, applicants should, in turn, assemble teams to address research challenges within a given mandate area, contaminant, or exposure scenario with the greatest potential to support SRP’s goal to protect human health and the environment from hazardous substances.  As such, applications should not overly-emphasize one mandate area (e.g. “health effects”) if another mandate area (e.g. “remediation” or “detection” technology) is the critical gap in knowledge most likely to prevent exposure to hazardous substances. 

NOTE (Community Engagement Research Projects): SRP also encourages applicants to include, as part of their Center, a community engagement research project.  These hypothesis-driven research projects address science-based questions formulated by the community.  Such project would count towards one of the minimum two biomedical or two non-biomedical projects, depending on the theme of the research project.  These projects should utilize community-based participatory processes of planning, implementing, and communicating pertinent scientific results from primary research.  Please see “Community Engagement Core” section below for definition of target communities and for a description of “Community-Based Participatory Processes.”  Community engagement research projects will be reviewed as research projects (see Section V. Application Review Information); however, applicants should include a plan for how community engagement activities will be conducted in partnership with the target community.  The plan must indicate how the participating community (or community group) will be involved in the design and approach of the activity from the onset through to the conclusion of the activity.  Letter(s) of support from the participating community or community group should be included in these applications.  As with all research projects, a tentative sequence or timetable for the project should be included.  Examples of community engagement research project themes may be found in the “Suggested Research Topics” document on the following website (http://www.niehs.nih.gov/research/supported/srp/funding/rfa.cfm).

Community Engagement Core (Required):

SRP requires each Center to establish a Community Engagement Core (CEC) to enhance the exchange of knowledge and to support the needs of the community with regard to the science emanating from the Center.  SRP defines target communities as those impacted by sites contaminated with hazardous substances; therefore, CEC activities should involve partnerships with members of the affected community.  Partnerships may also include community-serving organizations such as: local government groups, Tribal councils, community service groups focused on educating the community about local issues, or non-governmental organizations working closely with a community.  There is particular interest in engagement of economically disadvantaged, environmental justice (EJ), and Tribal communities which are severely impacted by sites contaminated with hazardous substances.

The CEC is to be designed to fit within the theme of the Center and to support the needs of the community.  Appropriate objectives include capacity building, developing tools/resources, facilitating bidirectional exchange between Center scientists and the community, etc.  Examples of appropriate CEC activities include:

As an outgrowth of these activities, interactions with the community should enhance the Center’s research agenda, providing a source of information valuable for the Center’s planning purposes or for the development of community engagement projects. 

Each CEC will include a timeline with milestones, measurable outcomes, and a process to guarantee effective bi-directional exchange of needs, recommendations, and results.  (See Section III.3 for budget details).

Community-Based Participatory Processes: Community Engagement Cores, as well as community engagement research projects, should employ community-based participatory processes of planning, implementing, and communicating pertinent results.  Hence, the following information should be included with the application:

NOTE: All Community Engagement Core activities (and, if applicable, community engagement research project activities) should be coordinated with the appropriate offices in EPA, ATSDR, state, local, or Tribal agencies.  This coordination should not compromise the independence of the engagement efforts since the community may value the support of a non-regulatory agency.  All activities will follow effective and sensitive engagement protocols especially as they pertain to communities affected by Superfund sites.  This includes recognition of and sensitivity towards specific cultural identities and characteristics (e.g., language and beliefs; challenges in discussing health effects; or non-English speaking stakeholders).  A plan should be included for coordination with the Center's Research Translation Core for interaction with government agencies and for communicating to other SRP Centers the lessons learned from Center Community Engagement Cores (and, if applicable, from community engagement research projects).

Research Translation Core (Required):

NIEHS requires a Research Translation Core (RTC) in each SRP Center grant application. For the purpose of this FOA, the SRP defines Research Translation as “communicating and facilitating the use of research findings emanating from the Center in the manner most appropriate for their application and the advancement of research objectives.”  The SRP Strategic Plan highlights the importance of investigator-initiated research translation.  Hence, each RTC has a critical role in assisting project leaders in translating research outcomes to appropriate audiences, thereby encouraging the accurate and timely use of these research products.

The RTC will have the following components in support of achieving effective research translation:

1) Communicating within SRP

2) Partnerships with Government Agencies

3) Technology Transfer

4) Information Dissemination to Other End-users 

For all proposed activities, the RTC must describe goals, identify specific projects/cores involved, include a plan for coordinating these activities, delineate a timeline with milestones for achievement of these goals, and a description of the process for outcome-reporting to relevant stakeholders.

1)  Communicating within SRP:  NIEHS requires the RTC to communicate both within its institutional Center as well as the greater SRP community (other SRP Centers and SRP staff at NIEHS).  This role has implications on four important levels:

a).  Project-specific translation: RTC will work with project investigators to identify and coordinate research translation opportunities for each Center project (and cores, as appropriate);

b).  Center-specific translation: pursuing research translation opportunities emanating from the goals of the overall Center (as opposed to an individual research project);

c).  SRP communication: reporting translation activities to SRP staff at NIEHS; and

d).  Cross-Center communication: communicating with RTCs from other SRP Centers.

SRP requires a plan for coordinating activities at all four levels.  Of note, a direct line of communication between the Administrative Core and the RTC is extremely important, given the role of the Administrative Core to ensure an effective research translation strategy for the Center.

2)  Partnerships with Government Agencies:  Establishing ongoing communication with the federal, state, local, and/or Tribal agencies charged with protecting human health and the environment is of high importance.  These partnerships ensure that governmental offices have first-hand access to the valuable resources the Center can provide, and that the investigators have feedback on the real and immediate needs faced by their counterparts in the public sector.  US EPA and ATSDR are directly involved in the National Superfund efforts; therefore, partnerships with these agencies are a high priority to SRP.  It is important that each applicant’s plan delineates bi-directional interactions with the appropriate government agencies, identifying shared interests and outlining how to address these needs/interests.  In addition, the Community Engagement activities may require liaison with government agencies; therefore, RTC plans should indicate lines of communication with CEC, as applicable.

3)  Technology Transfer:  It is important that each Center identifies opportunities and delineates mechanisms for the transfer of biomedical and non-biomedical technologies generated by the grantee into the hands of an end-user.  This may be accomplished through coordinating with formal technology transfer mechanisms (patents, Small Business Innovation Research/Small Business Technology Transfer Research grants, etc.) as well as informally through moving research from bench scale to demonstration, creating web-accessible data sharing systems to host information that may improve upon current risk assessments, or moving biomarker research towards epidemiological, clinical, or population based applications.  As part of technology transfer, grantees are encouraged to provide informal technology support, to document the use of the research product, and to assess its value to public health or environmental management.

4)  Information Dissemination to Other End-users: Another important RTC activity is to transfer the knowledge gained from Center activities (scientific discoveries, research findings, etc.) beyond the government or marketplace, allowing Center outcomes to make a broader impact.  SRP therefore requires a plan to disseminate information from the Center to other important end-users such as formal/informal educational groups, hazardous waste practitioners, the lay public, other academic researchers, etc.  To reach these stakeholders, a variety of mechanisms would be appropriate activities for the RTC including:

For all such activities, best communication practices must be utilized.  As a reference, please see the NIH website on plain language: http://grants.nih.gov/grants/plain_language.htm.  Use of web-broadcasting of these communication activities is particularly encouraged to accommodate stakeholders in remote locations or with limited travel options.  

Administrative Core (Required):

Through the required Administrative Core, the Principal Investigator provides leadership and guidance in fulfilling the stated objective of his or her Center.  To accomplish this, the applicant must create within the Administrative Core an infrastructure that promotes cross-discipline interactions among all of the projects and cores and ensures research translation. The structure of this core will provide the Principal Investigator with a mechanism for:

To demonstrate how the core will achieve its administrative functions, the applicant will include a description of the lines of communication among the Center scientists, and a description of the mechanisms to be used to encourage and ensure the integration and interaction between the biomedical and non-biomedical projects within the Center.  In addition, a direct line of communication between the Administrative Core and the Research Translation Core should be delineated, as both cores serve a critical role for Center integration.

To aid the Principal Investigator in achieving the goals set forth for his or her Center, the establishment of an External Advisory Committee is required to provide guidance to the Principal Investigator in the following areas:

The composition of the committee will reflect the goals of the Center and will include appropriate scientific expertise and appropriate stakeholders including representatives from the USEPA, ATSDR, industry, and/or community organizations, as examples.

Research Support Cores (Required):

The SRP requires that a Center has at least one Research Support Core. The intent is that this Core will provide essential, centralized services or resources that will result in an economy of effort and/or savings in the overall costs of a Center.  Well designed cores also serve as a useful tool in promoting interdisciplinary activities. By definition, a Research Support Core must support two or more research projects. Typical core facilities include laboratory facilities, biostatistics and/or bioinformatics support, or analytical equipment and services.  The applicant must include in his/her description of these cores the services to be rendered, the methodological approaches to be used and a plan for prioritizing the use of the facility by Center members.  (See Section IV.6.B. for additional requirements.) 

Training Core (Optional):

SRP strongly encourages applicants to include a Training Core, which supports graduate and postdoctoral level cross-disciplinary training in fields related to environmental health and environmental science/engineering.  The Training Core needs to reflect the interdisciplinary nature of the overall research effort of the Center enhancing cross training of trainees in disciplines not traditionally linked in the university graduate structure. For instance, trainees pursuing degrees in the non-biomedical areas should be encouraged to understand how their research fits into the context of environmental health sciences and vice versa for biomedical trainees. In addition to providing students with unique opportunities in interdisciplinary research, the SRP also encourages the Training Cores to facilitate practical opportunities for coordination or collaboration among other grantees and for communicating research outcomes to diverse audiences.  For example, all researchers need to know how to explain their work in a manner easily understood by the intended audience – whether the audience be the public or professionals in other areas of science.  SRP also encourages the Training Core to formally support trainee participation in the Community Engagement and Research Translation Cores. Opportunities such as this will provide students with valuable insights on the full cycle of the research that they conduct.

NOTE:  The training of pre- and post-doctoral students may be carried on outside the structured Training Core. In these cases, the budgets for these students should be part of the project or core budgets rather than the Training Core budget.  In keeping with the NIH efforts to train members of minority groups, and those with disabilities, applicants are encouraged to consider these candidates in their recruitment efforts. (See Section III.3 for budget details).

Section II. Award Information
Funding Instrument

Grant

Application Types Allowed

New
Renewal
Resubmission

The OER Glossary and the PHS398 Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

The NIEHS intends to commit  $10 million in FY 2012 to fund three to four SRP grants in response to this FOA.

Award Budget

A new applicant may request a budget for direct costs of up to $1.8 million dollars for the first year.  Applicants submitting renewal  applications may request up to a three percent increase above the awarded direct costs of the last year of their continuation project (non-competitive renewal). 

For all applicants, budgets submitted in subsequent years may not exceed an escalation of three percent on recurring direct costs.

Award Project Period

New applicants may propose a project period of up to four years. Renewal applicants may propose a project period of up to five 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:

 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.

Required Registrations

Applicant organizations must complete the following registrations as described in the PHS398 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 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.

Eligible Individuals (Project Director/Principal Investigator)

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.

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

Only one application per accredited institution of higher education (normally identified by having a unique DUNS number or NIH IPF number) is allowed.

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. Resubmission applications may be submitted, according to the NIH Policy on Resubmission Applications from the PHS398 Application Guide.

Other-Special Eligibility Criteria

Applicants must propose a multi-project, multidisciplinary research Center that addresses a problem-based, solution-oriented theme that is related to the goals of the SRP. 

The applicant must name a Principal Investigator as the designated leader of the SRP multi-project grant to provide scientific and administrative leadership to the Center.  The Principal Investigator must commit a minimum of 1.8 person months to the administration of the Center.

In order to be considered for funding each application must successfully meet the following minimum requirements:

In addition to these required Center components, it is important for the applicant to recognize that the SRP is more than a basic research program and is strongly encouraged to make investments in training through an optional Training Core. 

Section IV. Application and Submission Information

1. Address to Request Application Package

Applicants are required to prepare applications according to the current PHS 398 application forms in accordance with the PHS 398 Application Guide.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the PHS398 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.

Letter of Intent

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

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

Descriptive title of proposed research  (per project/core)
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:

Janice B. Allen, Ph.D.
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 3080
Research Triangle Park, NC 27709
email: Allen9@niehs.nih.gov
office:  919-541-7556
fax:     301-451-5715

Please note that submission of the letter of intent by email is preferred.

Application Submission

Applications must be prepared using the PHS 398 research grant application forms and instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

At the time of submission, two additional paper copies of the application and all copies of the appendix files must be sent to:

Janice B. Allen, Ph.D.
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 3080
Research Triangle Park, NC 27709
email: Allen9@niehs.nih.gov
office:  919-541-7556
fax:      301-451-5715

Page Limitations

For this FOA, a 12-page limit applies to the Center Introduction (part of Section II, the overall center description) and the Research Strategy section of all projects and cores (part of Sections lll-Vlll).  Details are provided in the “Application Guidelines” document, found on http://www.niehs.nih.gov/research/supported/srp/funding/rfa.cfm to supplement the PHS 398 instructions.

Research Plan

All instructions in the PHS398 Application Guide must be followed, with the following additional instructions in the SRP application guidelines:http://www.niehs.nih.gov/research/supported/srp/funding/rfa.cfm.

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 PHS398 Application Guide.

Appendix

Do not use the appendix to circumvent page limits. Follow all instructions for the Appendix (please note all format requirements) as described in the PHS398 Application Guide. 

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. 

Information on the process of receipt and determining if your application is considered “on-time” is described in detail in the PHS398 Application Guide.

Applicants may track the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

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 received on or before the due dates in Part I. Overview Information. If an application is received after that date, it will not be reviewed.

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.

A.  Application Guidelines. 

The applications submitted in response to this FOA are complex, and the scientific and programmatic information needed to adequately assess a grant proposal is not fully accommodated within the instructions accompanying the PHS 398 form.  Therefore, applicants need to follow the detailed guidelines that are provided in the “Application Guidelines” document, found on http://www.niehs.nih.gov/research/supported/srp/funding/rfa.cfm, to supplement the PHS 398 instructions. 

In general an SRP grant proposal will consist of the following categories of information:

Section l.  This section consolidates the budget information, the list of all professional and non-professional personnel, biosketches for all key personnel, institutional environment and resources and tables of core utilization and use of human subjects/vertebrate animals for the entire applicant’s Center.

Section ll.  This section is unique to the multi-project application.  The information requested in this section, for the most part, is not covered in the PHS 398 and includes: an overall “Center Introduction” describing the major theme, goals and objectives; the multidisciplinary nature of the Center and the interactions between the projects and cores; an indication of project designation as biomedical, non-biomedical, and/or community-engagement; a description of the role of the Principal Investigator; a description of the organizational structure of the applicant’s Center including an administrative and a management plan to achieve an integrated coordinated research Center; and for competing renewals, a general progress report.  For resubmission (amended) applications, an additional introduction section is required.  The “Center Introduction” component of “Section II” is limited to 12 pages.

Section lll- Vlll.  These sections contain the research plans for the individual research projects, Research Support Cores, Administrative Core, Research Translation Core, Community Engagement Core and Training Core and follow the guidelines established in the PHS 398.  Note: according to the Restructured Research Plan, as indicated in NOT-OD-09-149, the Research Strategy section should consist of significance, innovation, approach and either preliminary studies (new applications) or progress report (for renewal/revision applications), as applicable.  The Research Strategy section is limited to 12 pages.

Section lX-Xl.  These sections include the Plan for Data Sharing, the Checklist and Appendix materials.

B. Quality Assurance Statement. 

Quality Assurance Statements will be necessary ONLY for Research Support Cores that provide analytical, quantitative services to the applicant’s Center.

EPA regulations as stated in 40CFR30.54 require the inclusion of a Quality Assurance Narrative Statement (QANS, OMB # 2080-0033, approved 8/14/97) for any project application involving data collection or processing, environmental measurements, and/or modeling. The QANS provides information on how quality processes or products will be assured. NIEHS cannot consider applications incomplete without this statement; however, it requests that the QANS be included with all applications that contain analytical and quantitative cores. For awards that involve environmentally related measurements or data generation, a quality system that complies with the requirements of ANSI/ASQC E4, "Specifications and Guidelines for Quality Systems for Environmental Data Collection and Environmental Technology Programs," must be in place. The Quality Assurance Statement should not exceed two pages. This Statement should, for each item listed below, present the required information, reference the specific page and paragraph number of the project description containing the information, or provide a justification as to why the item does not apply to the proposed research.

1. Discuss the activities to be performed or hypothesis to be tested and criteria for determining acceptable data quality. (Note: Such criteria may be expressed in terms of precision, accuracy, representativeness, completeness, and comparability or in terms of data quality objectives or acceptance criteria. Furthermore, these criteria must also be applied to determine the acceptability of existing or secondary data to be used in the project. In this context secondary data may be defined as data collected for other purposes or from other sources, including the literature, compilations from computerized data bases, or results from mathematical models of environmental processes and conditions.)

2. Describe the study design, including sample type and location requirements, all statistical analyses that were or will be used to estimate the types and numbers of samples required for physical samples, or equivalent information for studies using survey and interview techniques.

3. Describe the procedures for the handling and custody of samples, including sample collection, identification, preservation, transportation, and storage.

4. Describe the procedures that will be used in the calibration and performance evaluation of all analytical instrumentation and all methods of analysis to be used during the project. Explain how the effectiveness of any new technology will be measured and how it will be benchmarked to improve an existing process, such as those used by industry.

5. Discuss the procedures for data reduction and reporting, including a description of all statistical methods with reference to any statistical software to be used to make inferences and conclusions. Discuss any computer models to be designed or utilized with associated verification and validation techniques.

6. Describe the quantitative and/or qualitative procedures that will be used to evaluate the success of the project, including any plans for peer or other reviews of the study design or analytical methods prior to data collection.

ANSI/ASQC E4, "Specifications and Guidelines for Quality Systems for Environmental Data Collection and Environmental Technology Programs," is available for purchase from the American Society for Quality, phone 1-800-248-1946, item T55. Only in exceptional circumstances should it be necessary to consult this document.

C. Annual Meetings.

It is the intent of the NIEHS to hold annual grantee meetings. Funds for travel by appropriate staff (i.e., Principal Investigator, Business Manager, and four students) to attend a three-day meeting shall be included in the Administrative Core’s budget for each year. It is also anticipated that the Community Engagement, Research Translation, and Training Core Leaders will convene at the annual meeting, and expenses for this travel should be included in their individual budgets. The location of the meeting site will rotate among the different grantees and Research Triangle Park, NC. A report of attendees at the annual meeting is required in the non-competing continuation progress report.    

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.

For this particular announcement, note the following:

The initial review for scientific and technical merit will emphasize two major aspects: (1) Overall Impact - Overall; and (2) Overall Impact - Research Projects and Cores.

1)  Overall Impact - Overall is the review of the Overall SRP Center application, i.e. the multi-project grant as an integrated research effort of projects and support cores focused on a problem-based, solution-oriented theme.  Reviewers will provide an overall impact/priority score in consideration of the five Scored Review Criteria (Significance, Investigator, Innovation, Approach, and Environment) as well as the following additional review criteria: Multidisciplinary and Interdisciplinary Nature of the Center; Review Criteria for Renewal Applications (as applicable).

2)  Overall Impact - Research Projects and Cores is the review of each research project, research support core and other core components independently.  Reviewers will provide an overall impact/priority score in consideration of the five Scored Review Criteria (Significance, Investigator, Innovation, Approach, and Environment), additional review criteria (Protections for Human Subjects, Vertebrate Animals, Inclusion Plans, and Biohazards) and the Project/Core's Contribution to the Overall SRP Center.  There are additional review elements for Community Engagement Cores/Projects and for Renewal Applications.  Some cores (Administrative, Research Support, Research Translation, and Training) have additional review criteria specific to that core (described below).

Overall Impact - Overall

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

Scored Review Criteria - Overall

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

Significance

Does the overall Center address an important problem or a critical barrier to progress in the field? If the aims of the  overall Center are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? 

Does the Overall SRP Center address an important problem or critical barrier to our knowledge of human health effects, risks, detection and mitigation of hazardous substances in the environment?

If successful, would the Overall SRP Center provide data, information, and knowledge to inform the risk assessment and remediation management processes for hazardous waste sites?  Will the Center provide a rigorous scientific basis for effective decision-making?

Is the importance of the proposed Center sufficient to further the knowledge of environmental health sciences to understand the physical, chemical and biological properties of hazardous substances in the environment?

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

Would the expected achievements of the overall program be possible through mechanisms other than this multi-project Center? 

Investigator(s)

Are the PD/PIs, collaborators, and other researchers well suited to the Center? 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)?

Do the experience and scientific leadership of the Center's Overall Principal Investigator allow him/her to effectively direct a large complex multidisciplinary Center?

Does the Center Principal Investigator demonstrate the appropriate ability and experience to coordinate the interactions of the research projects with effective utilization of cores to achieve programmatic goals?  Are the level of commitment and ability to develop a well-defined central research focus adequate?   

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?  Does the Overall SRP Center address an innovative hypothesis or critical barrier to progress in the understanding of the physical, chemical and biological properties of hazardous substances in the environment? 

Approach

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

If the Center 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?  Are the research projects and cores well integrated, well reasoned, and appropriate to the overall theme and goals of the proposed Center? Is there strong synergy among the combined efforts of the various investigators within the overall Center?

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 Center proposed? Will the Center benefit from unique features of the scientific environment, subject populations, or collaborative arrangements? 

Additional Review Criteria - Overall

As applicable for the Center proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact/priority score, but will not give separate scores for these items.

Multidisciplinary and Interdisciplinary Nature of the Overall SRP Center: 

Review Criteria for Renewal Applications:

Overall Impact - Research Projects and Cores

In addition to the Overall Impact score for the Overall Center, reviewers will provide an overall impact/priority score for each Research Project and Core to reflect their assessment of the likelihood for the project/core 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/core proposed).

Scored Review Criteria - Research Projects and Cores

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? If the study is successful, would it lead to incremental advance, or would it provide a substantial step forward that would likely not be achieved through mechanisms other than this multi-project program?  If successful, will the project result in knowledge or resources that could be utilized to improve human health, risk assessment, or improve the quality of the environment?  If successful, would the project provide data, information, and knowledge to inform the processes of risk assessment or remediation management for hazardous waste sites?  Will the project provide rigorous scientific data that might be used for effective decision-making?

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?    Does the project address an innovative hypothesis or critical barrier to progress in the field?  Does the project address an innovative hypothesis or critical barrier to progress in the understanding of the physical, chemical and biological properties of hazardous substances in the environment?  

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?  If the project involves research on hazardous waste sites or nearby communities, is there a plan proposed to involve the appropriate federal, state, or tribal agency? 

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 - Research Projects and Cores

As applicable for the project/core proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact/priority score, but will not give separate scores for these items.

Contribution to Overall SRP Center:

Review Criteria for Renewal Applications:

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.

Additional Review Criteria - Cores

In addition to the review criteria described above for research projects and cores, the following will be considered by the review panel in evaluating specified cores (and community engagement projects).

Review Criteria for Community Engagement Cores (and Community Engagement Research Projects):

Additional Review Criteria for the Administrative Core:

Additional Review Criteria for the Research Support Cores:

Additional Review Criteria for the Research Translation Core:

Additional Review Criteria for the Training Core:

Resubmissions

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the Center.

Renewals

For Renewals, the committee will consider the progress made in the last funding period.

Revisions

Not Applicable

Additional Review Considerations - Overall

As applicable for the 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

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).

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 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 will:

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center and 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 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 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 NGA. 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 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.

Section VII. Agency Contacts

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

Because of the complexity of the SRP, applicants are strongly encouraged to contact NIEHS staff early in the grant preparation process.  

 
Application Submission Contacts

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)

William Suk, Ph.D.
Director, Center for Risk and Integrated Sciences
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
P.O. Box 12233, K3-04
Research Triangle Park, NC 27709
Telephone: 919-541-0797
FAX:  919-541-4937
Email: suk@niehs.nih.gov

Claudia Thompson, Ph.D.
Center for Risk and Integrated Sciences
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
P.O. Box 12233, K3-04
Research Triangle Park, NC 27709
Telephone:  919-541-4638
FAX:  919-541-4937
Email:  thomps14@niehs.nih.gov

Heather Henry, Ph.D.
Center for Risk and Integrated Sciences
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
P.O. Box 12233, K3-04
Research Triangle Park, NC 27709
Telephone:  919-541-5330
FAX:  919-541-4937
Email:  henryh@niehs.nih.gov

Peer Review Contact(s)

Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).

Janice B. Allen, Ph.D.
Scientific Review Officer
Scientific Review Branch
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
P.O. Box 12233, K3-03
Research Triangle Park, NC 27709
Telephone:  919-541-7556
FAX:  301-451-5715
Email: Allen9@niehs.nih.gov

Financial/Grants Management Contact(s)

Lisa Archer Edwards, M.B.A.
Grants Management Branch
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
111 T.W. Alexander Drive
P.O. Box 12233, K3-11
Research Triangle Park, North Carolina 27709
Telephone:  919-541-0751
FAX: 301-451-5334
E-mail: archer@niehs.nih.gov

Michelle Victalino
Grants Management Branch
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
111 T.W. Alexander Drive
P.O. Box 12233, K3-11
Research Triangle Park, North Carolina 27709
Telephone:  919-316-4666
FAX: 301-451-5334
E-mail: victalinom@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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