Part I Overview Information

Department of Health and Human Services

Participating Organizations
National Institutes of Health (NIH) (http://www.nih.gov)

Components of Participating Organizations
National Institute of Environmental Health Sciences (NIEHS) (http://www.niehs.nih.gov)

Title: Superfund Hazardous Substance Research and Training Program (P42)

Announcement Type
This is a reissue of RFA-ES-08-005

Update: The following update relating to this announcement has been issued:

• October 29, 2010 - This RFA has been reissued as (RFA-ES-10-010).

Request For Applications (RFA) Number: RFA-ES-09-012

Catalog of Federal Domestic Assistance Number(s)
93.113, 93.143

Key Dates
Release Date: October 16, 2009
Letters of Intent Receipt Date: March 16, 2010
Application Receipt Date: April 15, 2010
Peer Review Date: October 2010
Council Review Date(s): January 2011
Earliest Anticipated Start Date: April 1, 2011
Additional Information To Be Available Date (Url Activation Date): Not Applicable
Expiration Date: April 16, 2010

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

• 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 the Superfund Research Program (SRP)]. SRP grants will support coordinated, multi-project, interdisciplinary research programs to address the mandates legislated under the Superfund Amendments and Reauthorization Act of 1986. These mandates include the development of: (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. The objective for the SRP is to develop a holistic research agenda for the protection of human health. This is accomplished by the establishment of interdisciplinary programs that link and integrate biomedical research with related non-biomedical (e.g., engineering, geology, ecology) research within the context of unique scientific themes developed by the applicant.
• Mechanism of Support. This FOA will utilize the NIH P42 multi-project grant mechanism. Applicants must include a minimum of two biomedical projects and two non-biomedical projects.
• Funds Available and Anticipated Number of Awards. The NIEHS intends to commit approximately $11.0 million in FY 2011 to fund four to five SRP grants in response to this Funding Opportunity Announcement (FOA).
• Budget and Project Period. A new applicant may request a budget for direct costs of up to $1.8 million dollars for the first year. Applicants submitting renewal (competing continuation) applications may request up to a three percent increase above the 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
• Research Strategy Page Limitations. For this FOA, the 12-page limit applies to the Program Introduction (part of Section II, the overall program description) and the Research Strategy section of all projects and cores (part of Sections lll-Vlll).
• Eligible Institutions/Organizations. Institutions/organizations listed in Section III, 1.A. are eligible to apply. Eligible organizations include accredited domestic institutions of higher education.
• Eligible Project Directors/Principal Investigators (PDs/PIs). Individuals with the skills, knowledge, and resources necessary to carry out the proposed research are invited to work with their institution/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.
• Number of Applications. Only one application per accredited institution of higher education will be accepted.
• Resubmissions. Resubmission applications will be accepted. Such applications must include an Introduction addressing the previous peer review critique (Summary Statement). See new NIH policy on resubmission (amended) applications (NOT-OD-09-003, NOT-OD-09-016).
• Renewals. Applicants may submit a renewal application.
• Special Date(s). See Receipt, Review and Anticipated Start Dates.
• Application Materials. See Section IV.1 for application materials. All applications, including resubmission, revision and renewal, submitted for due dates January 25, 2010 and beyond, must utilize the most current forms and instructions.
• Hearing Impaired. Telecommunications for the hearing impaired are available at: TTY: (301) 451-5936

Table of Contents

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Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives

Section II. Award Information
1. Mechanism(s) of Support
2. Funds Available

Section III. Eligibility Information
1. Eligible Applicants
A. Eligible Institutions
B. Eligible Individuals
2.Cost Sharing or Matching
3. Other - Special Eligibility Criteria

Section IV. Application and Submission Information
1. Address to Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Receipt, Review and Anticipated Start Dates
1. Letter of Intent
B. Sending an Application to the NIH
C. Application Processing
D. Application Assignment
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review Considerations
C. Resource Sharing Plan(s)
3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
3. Reporting

Section VII. Agency Contact(s)
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/Grants Management Contact(s)

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement

Section I. Funding Opportunity Description

1. 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) multi-project program grant. The SRP was created under the Superfund Amendments and Reauthorization Act (SARA) of 1986, when it was realized that that the strategies and technologies for the cleanup of Superfund sites were inadequate to address the magnitude and complexity of the problem. The legislation under which the SRP operates provides a framework that has allowed NIEHS the flexibility to create a university-based, multi-project research program for conducting science to address the wide array of scientific uncertainties facing the national Superfund program. With the assignment of the SRP to NIEHS, the goal of the Program is to improve public health by supporting integrative research that is multidisciplinary in nature and includes the ability to identify, assess, and evaluate the potential health effects and risks of exposure to hazardous substances; to develop innovative detection and monitoring techniques for site assessment; and to develop innovative remediation technologies for reducing potential exposure to hazardous substances.

Applicants responding to this FOA are expected to develop an over-arching conceptual theme to guide the scientific direction of the Program’s interdisciplinary/multidisciplinary research team. As a guiding principle, applications should have the following components:

• Relevance to Superfund: The research team should focus on environmental exposures encountered at hazardous waste sites currently or, with proper justification, contaminants of emerging human health concern.
• Responsive to Mandates: As described in SARA Section 311(a) Hazardous Substances Research and Training, NIEHS was authorized to create a basic research and training program for the development of (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. Each research project within the multi-project program should address at least one of these mandates.
• Integration of Disciplines Under a Central Theme: A conceptual theme should be developed that encompasses a holistic approach to protecting human health by incorporating the principles of environmental health sciences and the engineering, geochemical and ecological sciences within the framework of a basic research program. The development of a thematic concept for an SRP application can be focused in many different ways, often driven thematically by a particular chemical or class of chemicals; by a common mechanistic pathway such as oxidative stress; by a particular disease, dysfunction or organ system such as the neurological system; by methodological approaches such as biomarker development or the use of omics technologies; or by a site-based theme. It is expected that the overall theme will foster collaboration, whereby projects are integrated and specific emphasis is placed on interactions between the biomedical and non-biomedical research projects.
• Advancement of Science: The scientific approaches to be undertaken should focus on improving our understanding of the multiple aspects of environmental health sciences and environmental sciences research. Individual projects within a proposed program should be stand-alone and should employ state-of-the-art methods, approaches, and techniques to understand the underlying phenomena under investigation. The innovative aspect of some projects may be the integrative nature of the proposal. For example: using environmental genetics and genomics to discern the contributions of environmental and genetic factors in relation to disease susceptibility in vulnerable populations or in relation to the impact on microbial communities involved in biodegradation; developing novel computational, statistical, and/or mathematical tools to create risk assessment models that incorporate the complex biological data being generated through high-data content approaches; employing fate and transport modeling of contaminants in environmental media as it relates to the development of effective remediation strategies or for predicting exposure risk in humans or ecosystems; or development and application of bioengineered devices to study the exposure response disease paradigm in living cells and tissues.
• Translation of Science: In addition to the strong basic research focus of the Program, there is an equally important commitment to create an environment that fosters the translation of the scientific accomplishments emanating from the Program to its stakeholders -- whether to industry via technology transfer, to the government through partnerships, or to the public through communicating to broad audiences. A proactive approach should be developed through a required Research Translation Core for translating the scientific accomplishments emanating from program projects to its many stakeholders.
• Outreach and Training: Through the Community Outreach Core and Training Core, programs are given the opportunity to build capacity within communities and to mentor the next generation of multi-disciplinary researchers. Although not required, these cores are considered an asset to multi-project programs in achieving a longstanding impact on society’s awareness of environmental risks and methods of prevention.

In an effort to address the programmatic goals of the national Superfund Program activities of the U.S. Environmental Protection Agency (EPA, http://www.epa.gov/superfund/index.htm) and the Agency for Toxic Substances and Disease Registry (ATSDR, http://www.atsdr.cdc.gov), SRP-funded research is expected to provide a fundamentally sound science base that is centered on use-oriented objectives. Accordingly, the goal of each program is to provide data, information, and knowledge to inform the risk assessment and remediation management processes for hazardous waste sites. In doing so, SRP accomplishes its ultimate goal of human health protection through providing a rigorous scientific basis for effective decision-making.

Research Scope

Research supported by the SRP should emphasize basic and applied research, using state-of-the-art techniques to improve the sensitivity and specificity for detecting hazardous substances and the adverse effects in humans or in ecosystems exposed to hazardous substances, as well as for developing a better understanding of the underlying biology responsible for these adverse effects. In addition, the applicant should emphasize research that studies the phenomena affecting transport, fate and transformation of hazardous substances, and develops remediation strategies that attenuate and mitigate exposure as necessary to protect human health and ecosystems. Projects should be hypothesis-driven or product-oriented research. Projects may utilize a variety of approaches to achieve program mandates:

Health Effects Research: Advanced techniques for the detection, assessment, and evaluation of the effect on human health of hazardous substances. 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 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, 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 important translational opportunities for improved risk assessment. Research should focus on environmentally-related diseases and pathways and should have relevancy to populations living near or exposed to contaminants from hazardous waste sites.

Risk Assessment Research: Methods to assess the risks to human health presented by hazardous substances. Research that informs the risk assessment process is a tremendous opportunity for SRP to make an impact on human health through a better understanding of exposure, together with knowledge of health effects (above). 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. Understanding the complex phenomena that impact exposure, a component of risk, is an important research focus for the SRP. Within the context of the SRP, this would include a variety of exposure science research domains: 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, to characterize the attributable risk from multiple exposures experienced over one’s lifetime, and to utilize cumulative risk models to synthesize findings from health effects research, susceptibility, and mode of action to support more complex exposure assessments to more diverse populations, including those with both medical and economic disadvantages. While 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, a higher priority will be placed on research with a clear connection to understanding exposures relevant to populations living near or affected by hazardous waste sites.

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, hence, SRP seeks development of methods and devices that offer precise and low-cost readings for assessing the extent of contamination 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 technologies, such as nanotechnology based sensors and probes, biosensors, new imaging modalities, self-contained miniaturized toxicity-screening kits, miniaturized analytical probes and data analysis tools that allow for real-time, on-site monitoring, are encouraged. Development of passive samplers and monitoring devices that are capable of multi-analyte readings and/or determination of the degree of bioavailability of a contaminant are sought. Sensor research should have applicability in the complex media encountered at hazardous waste sites (soil, sediments, groundwater, etc) but researchers are also encouraged to consider applicability of devices for biomonitoring, in collaboration with biomedical researchers. Similarly, tools developed and used for site assessment may also inform modeling approaches that 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 and utilization of non-toxic components (particularly for in situ devices), etc.

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 at hazardous waste sites. 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 and soils. Also important is research that focuses on the translation of these basic principles into feasible, efficient and cost-effective technologies to reduce the level of contaminants present in the environment. Accordingly, the SRP encourages a continuum of research that ranges from basic mechanistic research to technology development for biological, chemical, and physical means of remediation. Combined remedy approaches are encouraged as a means to maximize the complete degradation of hazardous substances at complex sites. SRP 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 provides an opportunity to collaborate with health effects researchers to assess and mitigate unintended toxicological implications of the remedy. These types of collaborations are encouraged.

Suggested Contaminants

SRP presents a unique opportunity to address research needs of existing Superfund sites; hence, research on 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:

• hazardous substances found with some frequency at Superfund sites;
• hazardous breakdown products of such substances formed in environmental media by physical, chemical or biological (e.g., plants, microorganisms, etc.) processes; and
• hazardous metabolites of the above substances or their breakdown products formed in humans or experimental animals.

The applicant should refer to the following CERCLA Priority List website for information on hazardous substances that are relevant to 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 due to demonstrated toxicological effects, high or increasing production volumes, and potential for human exposure from a point source. In many cases, these compounds are structurally similar to known environmental toxicants, but regulation is not yet in place. These substances include, but are not limited to:

• high production volume agents with demonstrated potential for human health and environmental impact;
• chemicals presumed to be toxic based on structural similarity to CERCLA Priority List hazardous substances and likely to cause exposures from a point source; and
• environmental contaminants of emerging interest due to rapidly increasing production volume combined with suspected toxicological and bioaccumulative characteristics.

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 such as leading to better decision making for risk assessors and remediation managers at National Priority List (NPL, i.e. Superfund) sites and/or addressing uncertainties involved in understanding disease/dysfunction for communities living near hazardous waste sites.

Broad Research Areas of Interest to SRP

• Bioavailability. Bioavailability crosses all scientific disciplines relevant to SRP. It is an important factor to consider in understanding the fate and transport of hazardous substances; the ability of hazardous substances to be internalized by microbes, wildlife and humans; and the ability once internalized to be available to tissues and organs. Bioavailability also impacts the degree to which a contaminant may be degraded by biological, chemical, or physical processes. Germane to risk assessment, bioavailability remains a factor for which there is a paucity of data (for many contaminants, media, and receptors) leading to default assumptions of total bioavailability which often result in costly risk reduction strategies that provide no added human health protection. Hence, there is tremendous potential for SRP research to contribute to science-based decisions for risk assessment and remediation management through improved measurement and mechanistic understanding of bioavailability. As such, the SRP seeks innovative research in bioavailability for health, risk, detection, and remediation sciences.
• Ecologic Studies. Utilization of ecologic studies as part of a basic research approach to achieving mandates of detection, risk, effects, and remediation are an important theme to SRP yet not well represented in the current portfolio. This includes understanding processes related to food chain transfer of xenobiotics, validating food chain bioaccumulation modeling for predicting long-term changes in tissue contaminant concentrations, assessing effects of contaminants on populations of sentinel species, or using of ecologically-based bioassays to assess toxicity reduction of remediation activities. The SRP also encourages the application of state-of-the-art methods and approaches to ecological studies such as use of omics tools, new sensor technologies and informatics with the goal of enhancing our understanding of ecological succession and biodiversity as a function of exposure to contaminants.
• Mixtures. Mixtures remain a vexing issue with regard to understanding risks of hazardous substances, limitations to remediation approaches, and interactions involved in a toxic response. While the program has representative research addressing binary mixtures and congener mixtures, SRP would like to encourage research in more complex mixtures utilizing highly innovative statistical approaches, high-throughput techniques, and risk assessment frameworks that accommodate complex mixtures of contaminants. In addition, research that fills data gaps in the effects of multiple stressors (including radionuclide, chemical, and mineral contaminants) on humans or biota in order to identify patterns of synergism, antagonism, or cumulative effects is sought.

Specific Research Needs Identified by EPA and ATSDR

SRP values research that addresses specific research needs identified by sister agencies EPA and ATSDR. The EPA Office of Research and Development (ORD) conducts a multi-year effort to plan the direction of their research program in selected topic areas over five or more years (http://www.epa.gov/OSP/myp.htm). The ATSDR’s congressionally mandated Substance-Specific Applied Research Program (SSARP) consists of a research agenda for priority hazardous substances. In establishing the SSARP, ATSDR first identifies data needs in its Toxicological Profiles for these substances http://www.atsdr.cdc.gov/pdns/unfilled.html). It may be helpful to consider these web sites in preparing the SRP application. In addition, specific research needs have been identified by EPA and ATSDR staff as areas that would benefit from basic research. Although not an exhaustive list, these research needs include:

• Asbestos: the study of asbestos (and related mineral fibers or elongated mineral particles) including determinants of fiber toxicity; studies on non-cancer effects especially pleural changes: fiber size distribution and mineralogy relation to adverse health effects; immunotoxicity; mutagenicity; improving dosimetry of epidemiological studies; effect of variable levels of exposure (shorter term and/or lower levels); risk factors including early life exposures, smoking, lung diseases, and medical intervention; fiber mechanisms leading to disease; and biomarkers of exposure and disease.
• Contaminated Sediments: the study of contaminated sediments including the development, demonstration, and validation of technologies or methods to remediate and/or monitor contaminated sediment exposures and adverse biologic effects, and to assess the effectiveness of contaminated sediment remediation in protecting receptors of concern at Superfund sites. Also needed are new sediment amendments and reactive caps to reduce the toxicity and bioavailability of contaminated sediments.
• Cumulative Risk: methods to integrate risks of all chemical stressors (not just stressors related to nearby hazardous waste site) in communities exposed to contaminants. This type of research is particularly needed for tribal and environmental justice communities.
• Trichloroethylene: the study of the mechanisms and health consequences of exposure to trichloroethylene (TCE), and the development of remediation strategies to mitigate exposure.
• Vapor Intrusion: the development and application of methods to assess processes leading to vapor intrusion and resultant potential health effects and the development of cost-effective methods to detect vapor intrusion.

For more details on these research areas and other possible research topics, please refer to the Suggested Research Topics document on the following website (http://www.niehs.nih.gov/research/supported/srp/funding/rfa.cfm). In addition, 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 Program http://tools.niehs.nih.gov/srp/programs/index267.cfm.

CORES Required and Optional Program Components

Although novel, innovative, cutting-edge research projects are the nucleus of an SRP grant, it is the intent of the SRP that the research activities be integrated into an interdisciplinary program. In support of this goal, NIEHS requires the establishment of cores. Each grant application is required to have an Administrative Core, a Research Translation Core, and at least one Research Support Core. A Community Outreach Core and a Training Core may also be included in support of achieving a truly multidisciplinary approach to hazardous substances research.

Administrative Core (required component). Through the required Administrative Core, the Principal Investigator provides leadership and guidance in fulfilling the stated objective of his or her program. 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:

• planning and coordinating research activities
• integrating cross-discipline research
• overseeing fiscal and resource management.

To demonstrate how the core will achieve its administrative functions, the applicant will include a description of the lines of communication among the program 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 program. 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 program integration.

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

• the scientific merit of the research
• the relevance and importance of the individual components to the goals of the program
• the integration of research across disciplines
• the effectiveness of research translation activities in linking projects and stakeholders
• the appropriateness of outreach and training activities.

The composition of the committee will reflect the goals of the program 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 component). The SRP requires 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 program. 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 program members.

Research Translation Core (required component). NIEHS requires a Research Translation Core (RTC) in each SRP grant. For the purpose of this FOA, the SRP defines Research Translation as communicating and facilitating the use of research findings emanating from the Program in the manner most appropriate for their application and the advancement of research objectives. Hence, each RTC has a critical role 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) partnering with governmental agencies, (3) conducting technology transfer and (4) communicating to broad audiences. 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 Superfund Research Program: NIEHS requires the RTC to communicate both within its institutional SRP as well as the greater SRP community. This role has implications on four important levels: a) identifying and coordinating research translation opportunities for each program project (and cores, as appropriate), b) pursuing research translation opportunities emanating from the goals of the overall program (as opposed to an individual research project), c) reporting translation activities to SRP staff at NIEHS, and d) communicating with RTCs from other SRP institutions. 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 Administrative Core to ensure an effective research translation strategy for the program.

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 Program 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 Outreach Core requires liaison with government agencies; therefore, RTC plans should indicate lines of communication with COC, as applicable.

3) Technology Transfer: It is important that each program 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) Communicating to Broad Audiences: Another important RTC activity is communication of research findings to stakeholders beyond the government or marketplace, allowing program outcomes to make an impact on broader audiences. Broader audiences may include 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: sponsorship of one-day workshops for regional waste management professionals to tackle issues related to SRP-program research; development of project-relevant factsheets that translate complex research findings for the lay public (including language translation); and development of accessible advanced communication tools (internet or GIS-based technologies) to enhance transparency in environment and health interactions relevant to program research. For all such activities, best communication practices must be utilized. Particularly for stakeholders in remote locations or with limited travel options, there is a tremendous value to web-broadcasting and/or web-posting recorded archives of these communication activities.

Community Outreach Core (optional component). The SRP highly recommends the applicant to include a Community Outreach Core (COC) as an effective way to achieve SRP’s ultimate goal of human health protection. There is a growing interest in community outreach, and SRP anticipates that exchange of knowledge between communities and the research program can truly reduce exposures and improve health. For the purpose of this FOA, the SRP defines community outreach as extending support or guidance to communities, community advocates or community organizations. Appropriate target communities include those that (1) are living in proximity to, or affected by hazardous waste sites or (2) are exposed to hazardous substances via other pathways. Appropriate community groups include local government, 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 outreach to economically disadvantaged, environmental justice (EJ), and tribal communities which are severely impacted by hazardous waste sites.

The COC activities will complement the research strengths of the program and will follow effective and sensitive outreach protocols especially as it pertains to communities affected by Superfund sites. This includes recognition of and sensitivity towards specific cultural identities and characteristics (i.e., the Indian Nation, its language and beliefs; challenges discussing sickness and death with translation of science; using different approaches for different communities; or non-English speaking stakeholders).

Accordingly, at all phases, COC activities should be conducted in full partnership with the target community whereby the community participates in the design and approach of the activity at the onset through to the conclusion of the project. As an outgrowth of these activities, interactions with the community should enhance the program’s research agenda, providing a source of information valuable for program planning purposes. Examples of appropriate COC activities include:

• increasing accessibility to relevant information (assisting community in accessing pertinent information or translating materials into the community s native language)
• serving as a resource (e.g., responding to community’s questions)
• establishing collaborative projects among communities, investigators and other colleagues to address environmental problems (e.g., partnering with tribes in determining exposure pathways specific and relevant to their traditional and cultural practices).

Each COC 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).

Note: All activities should be coordinated with the appropriate offices in EPA, ATSDR, state or tribal agencies. This not only reinforces SRP goals of building partnerships with these agencies, but also ensures COC efforts are complementary to (not duplicative of) other agencies activities. This coordination should not compromise the independence of the outreach efforts since the community may value the support of a non-regulatory agency. In addition, the Research Translation Core requires liaison with government agencies; therefore, COC plans should indicate lines of communication with the RTC along with reporting to SRP at NIEHS.

Training Core (optional component). SRP strongly encourages applicants to include a Training Core, which supports graduate level cross-disciplinary training in fields related to environmental health. The Training Core needs to reflect the interdisciplinary nature of the overall research effort of the program 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 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 Outreach Core. 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).

Activities on Hazardous Waste Sites

Whether through project research or core activity, there are tremendous opportunities for interactions at Superfund or other managed hazardous waste sites. Although not a requirement, this is strongly encouraged. Such site activities must be conducted in coordination with appropriate federal or state site officials and must observe best safety practices. When applicable, applicants must:

• propose a procedure for coordinating and documenting site activities including record of the research conducted, sample collected, or translation/outreach activities and
• delineate procedures for bi-directional communication and outcome reporting to appropriate site officials, site managers, and SRP.

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.

See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.

Section II. Award Information

1. Mechanism of Support

This funding opportunity will use the P42 award mechanism(s). The Project Director/Principal Investigator (PD/PI) will be solely responsible for planning, directing, and executing the proposed project.

This FOA uses Just-in-Time information concepts. It also uses non-modular budget formats described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html).

2. Funds Available

• The estimated amount of funds available for support of four or five projects awarded as a result of this announcement is approximately $11 million for fiscal year 2011. An applicant may request a project period of up to five years. Future year amounts will depend on annual appropriations.
• A new applicant may request a budget for direct costs of up to $1.8 million for the first year. Applicants submitting renewal (competing continuation) applications may request up to a three percent increase above the 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.

Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the IC provides support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.

Facilities and administrative costs requested by consortium participants are not included in the direct cost limitation, see NOT-OD-05-004.

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

1.A. Eligible Institutions

You may submit (an) application(s) if your organization has any of the following characteristic:

• An accredited domestic institution 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.

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research as the PD/PI is invited to work with his/her institution 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 or Matching

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

3. Other-Special Eligibility Criteria

Applicants must propose a multi-project, multi-disciplinary research program that addresses a central theme and that is related to the goals of the SRP. This multidisciplinary effort should bring together investigators from different scientific disciplines to direct discrete Research Projects, each of which is to be related to the central theme developed for the applicant’s program. It is expected that the research team will include the expertise required to perform the research proposed and be comprised of scientists that represent the biomedical and non-biomedical (e.g., engineering, geology, ecology, etc.) fields of study.

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 program. The Principal Investigator must commit a minimum of 1.8 person months to the administration of the program.

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

• Two approved Biomedical Research Projects. These projects address biomedical or human health-related implications of hazardous substances. This includes: mechanistic-based toxicology studies, epidemiology, human risk assessment, genetic susceptibility, computational toxicology, etc.
• Two approved Non-Biomedical Research Projects. These projects address non-biomedical implications of hazardous substances that are not directly related to human health. This includes: engineering, geology, ecology, microbiology, fate and transport studies, hydrogeology, remediation and detection sciences, etc.
• An approved Administrative Core. The administrative core must include an external advisory committee which should provide oversight and advice to the Principal Investigator in accomplishing program goals.
• One approved Research Support Core. Research Support Cores must be used by at least two of the research projects.
• An approved Research Translation Core which must include plans for: (1) communicating within SRP, (2) partnerships with government agencies, (3) technology transfer, and (4) communicating to broad audiences.

In addition to these required program 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 other areas crucial to the Program. These include:

• A Community Outreach Core. The Community Outreach Core is limited to $100,000 direct costs in the first year, with subsequent years subject to the standard three percent cost escalations allowed by NIH. Support for appropriate staff positions, consultants, travel and supplies are allowed. The budget must include travel for the Core director or designee to attend the SRP annual meeting as it is expected that the Community Outreach Core Leaders will convene during this time.
• A Training Core. The direct costs for the Training Core are not to exceed six percent of the total direct costs for the total program budget. Individuals in the training positions must be considered employees of the institution and not trainees receiving stipends as in National Research Service Award programs. Salaries and fringe benefits consistent with institutional policies may be requested. Funds may also be requested for tuition, where appropriate, and travel to one scientific meeting per year.

Number of Applications. Applicants may submit only one application. Only one application per accredited institution of higher education will be accepted.

Resubmissions.Applicants may submit a resubmission application, but such application must include an Introduction addressing the previous peer review critique (Summary Statement). Beginning with applications intended for the January 25, 2009 official submission due date, all original new applications (i.e., never submitted) and competing renewal applications are permitted only a single amendment (A1). See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-003.html and NOT-OD-09-016. Original new and competing renewal applications that were submitted prior to January 25, 2009 are permitted two amendments (A1 and A2). For these grandfathered applications, NIH expects that any A2 will be submitted no later than January 7, 2011, and NIH will not accept A2 applications after that date.

Renewals. Applicants may submit a renewal application.

Section IV. Application and Submission Information

1. Address to Request Application Information

The current PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of the PHS 398. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: [email protected].

Telecommunications for the hearing impaired: TTY 301-451-5936.

2. Content and Form of Application Submission

Applications must be prepared using the most current PHS 398 research grant application instructions and forms. Applications must have a D&B Data Universal Numbering System (DUNS) number as the universal identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com/us/. The D&B number should be entered on line 11 of the face page of the PHS 398 form.

The title and number of this funding opportunity must be typed in item (box) 2 only of the face page of the application form and the YES box must be checked.

3. Submission Dates and Times

Applications must be received on or before the receipt date described below (Section IV.3.A). Submission times N/A.

3.A. Receipt, Review and Anticipated Start Dates
Letters of Intent Receipt Date: March 16, 2010
Application Receipt Date: April 15, 2010
Peer Review Date(s): October 2010
Council Review Date: January 2011
Earliest Anticipated Start Date: April 1, 2011

3.A.1. Letter of Intent

Prospective applicants are asked to submit a letter of intent that includes the following information:

• Descriptive title of proposed research
• Name, address, and telephone number of the Principal Investigator
• Names of other key personnel
• Participating institutions
• Number and title of this funding opportunity

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.

The letter of intent is to be sent by the date listed in Section IV.3.A.

The letter of intent should be sent to:

Sally Eckert-Tilotta, Ph.D.
Scientific Review Branch
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
111 T.W. Alexander Drive
P.O. Box 12233, MSC K3-03
Research Triangle Park, NC 27709
Phone: (919) 541-1446
FAX: (919) 316-4606
Email: [email protected]

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

3.B. Sending an Application to the NIH

Applications must be prepared using the forms found in the PHS 398 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)

Personal deliveries of applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).

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

Sally Eckert-Tilotta, Ph.D.
Scientific Review Branch
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
111 T.W. Alexander Drive
P.O. Box 12233, MSC K3-03
Research Triangle Park, NC 27709
Phone: (919) 541-1446
FAX: (919) 316-4606
Email: [email protected]

3.C. Application Processing

Applications must be received on or before the application receipt date described above (Section IV.3.A.). If an application is received after that date, the application may be delayed in the review process or not reviewed. Upon receipt, applications will be evaluated for completeness by the CSR and for responsiveness by the reviewing Institute Incomplete and/or non-responsive applications will not be reviewed.

The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial merit review unless the applicant withdraws the pending application. The NIH will not accept any application that is essentially the same as one already reviewed. However, the NIH will accept a resubmission application, but such application must include an Introduction addressing the critique from the previous review.

Information on the status of an application should be checked by the Principal Investigator in the eRA Commons at: https://commons.era.nih.gov/commons/.

4. Intergovernmental Review

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. The Grants Policy Statement can be found at NIH Grants Policy Statement.

Pre-award costs are allowable. A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new or renewal award if such costs: 1) are necessary to conduct the project, and 2) would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new or renewal award.

The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project (see NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.)

6. Other Submission Requirements

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 program.

Section ll. This section is unique to a multi-project application. The information requested in this section, for the most part, is not covered in the PHS 398 and includes: an overall Program Introduction describing the major theme, goals and objectives, the multi-disciplinary nature of the program and the interactions between the projects and cores; a description of the role of the Principal Investigator; a description of the organizational structure of the applicant’s program including an administrative and a management plan to achieve an integrated coordinated research program; and for competing renewals, a general progress report. For resubmission (amended) applications, an additional introduction section is required. The Program 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 outreach 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 program.

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 Outreach Core and Research Translation 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.

Research Strategy Page Limitations

For this FOA, the 12-page limit applies to the Program Introduction (part of Section II, the overall program description) and the Research Strategy section of all projects and cores (part of Sections lll-Vlll). Additional instructions may be found in the SRP application guidelines: http://www.niehs.nih.gov/research/supported/srp/funding/rfa.cfm.

Appendix Materials

All paper PHS 398 applications submitted must provide appendix material on CDs only. Include five identical CDs in the same package with the application. See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-031.html.

Do not use the Appendix to circumvent the page limitations. An application that does not observe the required page limitations may be delayed in the review process.

Resource Sharing Plan(s)

NIH considers the sharing of unique research resources developed through NIH-sponsored research an important means to enhance the value of, and advance research. When resources have been developed with NIH funds and the associated research findings published or provided to NIH, it is important that they be made readily available for research purposes to qualified individuals within the scientific community. If the final data/resources are not amenable to sharing, this must be explained in Resource Sharing section of the application. See http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm.

(a) Data Sharing Plan: Regardless of the amount requested, investigators are expected to include a brief 1-paragraph description of how final research data will be shared, or explain why data-sharing is not possible. Applicants are encouraged to discuss data-sharing plans with their NIH program contact. See Data-Sharing Policy or http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html.

(b) Sharing Model Organisms: Regardless of the amount requested, all applications where the development of model organisms is anticipated are expected to include a description of a specific plan for sharing and distributing unique model organisms and related resources, or state appropriate reasons why such sharing is restricted or not possible. See Sharing Model Organisms Policy, and NIH Guide NOT-OD-04-042.

(c) Genome-Wide Association Studies (GWAS): Regardless of the amount requested, applicants seeking funding for a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. A genome-wide association study is defined as any study of genetic variation across the entire genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight) or the presence or absence of a disease or condition. For further information see Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088, and http://grants.nih.gov/grants/gwas/.

Specific Instructions for Foreign Applications

All foreign applicants must complete and submit budget requests using the Research & Related Budget component found in the application package for this FOA. See NOT-OD-06-096, August 23, 2006.

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process.

2. Review and Selection Process

Review Process

Applications that are complete and responsive to the FOA will be evaluated for scientific and technical merit by an appropriate peer review group convened by National Institute of Environmental Health Sciences and in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/), using the review criteria stated below.

As part of the scientific peer review, all applications will:

• Undergo a selection process in which only those applications deemed to have the highest scientific and technical merit, generally the top half of applications under review, will be discussed and assigned an impact/priority score.
• Receive a written critique.
• Receive a second level of review by the National Advisory Environmental Health Council.

The mission of the NIH is to support science in pursuit of knowledge about the biology and behavior of living systems and to apply that knowledge to extend healthy life and reduce the burdens of illness and disability. Within this context, the goal of the SRP is to improve public health by supporting integrative research that is multidisciplinary in nature and includes the ability to identify, assess, and evaluate the potential health effects and risks of exposure to hazardous substances, to develop technologies for hazardous substance detection, and to develop innovative chemical, physical and biological technologies for reducing potential exposure to hazardous substances. As part of this mission, applications submitted to the NIH for grants or cooperative agreements to support biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

The initial review for scientific and technical merit will emphasize two major aspects: (1) review for the overall SRP application, i.e. the multi-project grant as an integrated research effort of projects and support cores focused on a central theme; and (2) review of each research project, research support core and other core components independently.

Review Criteria for the Overall SRP Program Application

Overall Impact. Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the

Overall SRP Program to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following five core review criteria, and additional review criteria (Multidisciplinary and Interdisciplinary Nature of the Program, Principal Investigator, and, as applicable, Review Criteria for Renewal Applications)

Significance: Does the Overall SRP Program address an important problem or a critical barrier to progress in the field? If the aims of the program 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 Program 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 Program provide data, information, and knowledge to inform the risk assessment and remediation management processes for hazardous waste sites? Will the program provide a rigorous scientific basis for effective decision-making?
• Is the importance of the proposed program 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 program 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 program?

Investigators: Are the PD/PIs, collaborators, and other researchers well suited to the Overall SRP Program? If Early Stage Investigators or New Investigators, 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 Overall SRP Program challenge and seek to shift current research or clinical research 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 Program 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 SRP Program’s strategy, methodology, and analyses well-reasoned and appropriate to accomplish the aims of the program? 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?

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

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

• Is there evidence of institutional support?

In addition to the above review criteria, the following criteria will be applied to applications in the determination of scientific merit and impact/priority score for the Overall SRP Program Application.

Multidisciplinary and Interdisciplinary Nature of the Overall SRP Program:

• Interdisciplinary Nature of Research Activities. Are the projects integrated around a central theme? Are there plans to effectively pursue interdisciplinary research objectives? Does the program propose a plan for the development of interdisciplinary collaboration among all components of the program?
• Coordination and Cohesiveness. Is there evidence of integration of the Administrative, Research Translation, Community Outreach and Training Cores with the Research Projects and Research Support Cores? Is there evidence for the translation and delivery of the research findings to appropriate audiences?
• Synergy of the Program. Is there evidence of meaningful interdisciplinary/multidisciplinary collaboration and synergistic potential among the research projects and cores? Is the whole greater than the sum of the parts? Is the size of the program sufficient to afford effective interaction focused on a specific central theme, but diverse in scientific disciplines in order to achieve meaningful contributions to protecting human health and the environment?
• Is there evidence of integration and interaction of the non-health related research with the health-based research as it contributes to the central theme of the program?
• For competing renewals, is there evidence that there were integration and synergy among the projects and cores within the program?

Overall SRP Program Principal Investigator:

• Do the experience and scientific leadership of the Principal Investigator allow him/her to effectively direct a large complex multidisciplinary program?
• Does the 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?

Review Criteria for Renewal Applications: In addition, for renewal applications the following will be considered for the Overall SRP Program:

• Is there evidence of progress and achievements specific to this program since the previous competitive review? Is there documentation through publications, conferences, etc. that demonstrates that collaboration between or among projects has occurred?
• Is there evidence that the cores have met their objectives and been well utilized by the individual research projects?
• Is there adequate justification for adding new projects or cores or for deleting components previously supported?
• Is there evidence that the aims of the Research Translation Core for developing approaches for transferring research findings to appropriate audiences such as EPA, EPA Regions, ATSDR, state and local professionals or other professionals working in the field of hazardous waste management have been met? Is there evidence that the transfer of research findings to these audiences has occurred?

Review Criteria for the Research Projects

Review of the individual research projects is similar to the review of investigator-initiated individual project grant applications (R01). The review criteria are as follows:

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 five core review criteria as well as the project’s Contribution to the Overall SRP Program.

Core Review Criteria. Reviewers will consider each of the five review criteria below in the determination of scientific and technical 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, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? Does the investigative team bring complementary and integrated expertise to the project (if applicable)?

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? Is there evidence of institutional support?

Contribution to Overall SRP Program: In addition to the standard criteria listed above, reviewers will evaluate each project for its contribution to the overall goals of the SRP application:

• Does the project contribute scientifically to the overall proposed programmatic theme (i.e., the importance of the ideas or aims, the rationale and originality of the approach, the feasibility of the methods and the value of the result)?
• Will the specific scientific objectives of each project benefit significantly from, or depend upon, collaborative interactions with other projects in the program (i.e., objectives that can be uniquely accomplished, specific contributions to the accomplishments of objectives in other projects, objectives that can be accomplished with greater effectiveness and/or economy of effort, etc.).
• For renewals, reviewers will evaluate whether previous specific aims, as funded, have been accomplished and whether the new research goals are logical extensions of ongoing work.

Review Criteria for Cores

In addition to the review criteria described above for research projects, the following will be considered by the review panel in evaluating the cores.

Review Criteria for the Administrative Core. The Administrative Core will be assessed based on the following criteria:

• Evidence that the lines of authority and the administrative structure are designed for effective management of the program. Is there a decision-making process for the management of funds and resources? Is there evidence of an ability to provide administrative support to the project and core leaders?
• Evidence of an internal plan to promote integration and coordination. Does the program’s internal plan promote coordination of interdisciplinary research and stimulate collaborations among constituent research projects and cores, particularly with regard to biomedical and non-biomedical project interactions?
• External advisory committee. Is there an appropriate plan to establish and use an external advisory committee? Do the members of the committee have the expertise required to evaluate all projects and cores and appropriately represent the applicant’s stakeholders (including US EPA or ATSDR)?
• Qualifications of the senior leaders of the administrative core. Does the senior leadership have appropriate experience and have they demonstrated effective and responsible leadership in the past? Is the percent effort requested adequate?
• Qualifications of the administrative staff. Are the qualifications, duties and time commitments of administrative staff appropriate to contribute to the needs and conduct of the program’s research activities?
• Adequacy of program resources. Are the resources committed to the Administrative Core adequate?

Review Criteria for the Research Support Cores. The Research Support Cores will be assessed based on the following criteria:

• The Core s utility to the program. Does each Research Support Core provide essential facilities or service for two or more of the Research Projects judged to have substantial scientific merit? Is the projected use sufficient to warrant establishment of the core? Are the core facilities contributing to the overall research activities of the program? Is there evidence of enhanced efficiencies (including cost) afforded by the Core?
• The quality of the facility or service provided. Is the Quality Control and Quality Assurance plan for cores providing quantitative analyses adequate?
• Prioritization. Is there a prioritization plan for core usage?
• The qualification of the personnel involved. Does the staff have the appropriate experience and level of commitment?
• For renewals. Is there evidence that the previous aims, as funded, were accomplished?

Review Criteria for the Research Translation Core. The Research Translation Core will be assessed based on the following criteria:

• Qualifications. Are the qualifications of proposed personnel adequate to conduct the activities described for the Core?
• Communication within SRP. Is the proposed plan adequate for identifying research translation opportunities on a project-level as well as a program-level? Is there a plan for communicating with the SRP at NIEHS and with other SRP RTCs? Is there a plan for coordinating with the Administrative core?
• Partnering. Is the proposed plan to partner with governmental agencies adequate? Does the proposed plan specify bi-directional interactions?
• Technology transfer. Is the proposed plan to identify technology transfer opportunities and to assist in the advancement of technologies into application appropriate?
• Communication with broad audiences. Is the proposed plan to communicate to broad audiences adequate? Is there a plan for identifying and engaging target audiences? Are there adequate commitment and support for the approach being developed? Are the communication tools selected appropriate for the intended audience?
• Milestones. Are milestones delineated, realistic and appropriate?
• Adequacy of program resources. Are the resources committed to the Research Translation Core appropriate for the proposed activities?
• For renewals. Is there evidence that the previous aims, as funded, were accomplished?

Review Criteria for the Community Outreach Core. The Community Outreach Core will be assessed based on the following criteria:

• The adequacy of the approach. Does the COC approach complement the research strengths of the program? Is the proposed approach appropriate, adequate and feasible? Is there evidence of community involvement in the development of the core’s goals? Is the approach appropriate according to community socioeconomic and cultural factors?
• Coordination and collaboration. Is there evidence that the coordination and collaboration with appropriate community groups, and state, local and federal agencies are adequate?
• Milestones. Are milestones delineated, realistic and appropriate? Is there evidence of a process for bi-directional exchange of needs, recommendations and results from the COC activity?
• Qualifications. Are the qualifications of proposed personnel to conduct the activities described appropriate?
• For renewals. Is there evidence that the previous aims, as funded, were accomplished?

Review Criteria for the Training Core. The Training Core will be assessed based on the following criteria:

• Objectives. Are the objectives, design, and direction for the research-training program appropriate? Are the approaches and methods proposed adequate to develop training curriculum and courses that provide opportunities to interface with different scientific disciplines? Does the training program reflect the interdisciplinary nature of the program?
• Recruitment and selection. Are plans for the recruitment and selection of individuals appropriate?
• Adequacy of the training environment. Is the institutional commitment adequate? Are the quality of the facilities and the availability of courses appropriate to the SRP? Is there an availability of research support for post-doctoral training?
• For renewals. Is there evidence that the previous aims, as funded, were accomplished?

Additional Review Criteria

As applicable for the project proposed, reviewers will consider the following additional items in the determination of scientific and technical merit, 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.

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.

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.

Resubmission Applications. When reviewing a Resubmission application (formerly called an amended application), the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Renewal Applications. When reviewing a Renewal application (formerly called a competing continuation application), the committee will consider the progress made in the last funding period.

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

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 Considerations

As applicable for the project proposed, reviewers will address 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.

Budget and Period Support. Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research. For Research Support Cores, are the requests for equipment, supplies and other items to support the activity of the core appropriate and justified?

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).

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.

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 (http://grants.nih/gov/grants/policy/data_sharing/data_sharing_guidance.htm); 2) Sharing Model Organisms (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html); and 3) Genome Wide Association Studies (GWAS) (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html).

Selection Process

The following will be considered in making funding decisions:

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

3. Anticipated Announcement and Award Dates

Not Applicable

Section VI. Award Administration Information

1. Award Notices

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.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official.

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. See Also Section IV.5. Funding Restrictions.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the Notice of Award. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm) and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm).

The following Terms and Conditions will be incorporated into the award statement and will be provided to the Principal Investigator as well as to the appropriate institutional official, at the time of award.

• An annual grantee meeting, to be held at one of the grantee s sites or in Research Triangle Park, NC is planned for the exchange of information among investigators. Applicants must budget travel costs associated with this meeting for the Principal Investigator, Business Manager, at least four students, the Research Translation and Community Outreach Core Leaders for each year - this must be reported each year on the non-competitive renewal.
• The multi-project P42 grant mechanism is under expanded authorities. However, carry-over of an unobligated balance into the next budget period requires Grants Management Officer prior approval.

3. Reporting

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.

Section VII. Agency Contacts

We encourage your 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. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues:

1. Scientific/Research Contacts:

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: [email protected]

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: [email protected]

Beth Anderson, M.A.
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: 919-541-4481
FAX: 919-541-4937
Email: [email protected]

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: [email protected]

2. Peer Review Contacts:

Sally Eckert-Tilotta, Ph.D.
Scientific Review Branch
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
111 T.W. Alexander Drive
P.O. Box 12233, MSC K3-03
Research Triangle Park, NC 27709
Phone: 919-541-1446
FAX: 919-316-4606
Email: [email protected]

3. Financial or Grants Management Contacts:

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: [email protected]

Section VIII. Other Information

Required Federal Citations

Use of Animals in Research:
Recipients of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf) as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm) as applicable.

Human Subjects Protection:
Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types of clinical trials, including physiologic toxicity and dose-finding studies (phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative trials (Phase III). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

Sharing Research Data:
Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing).

Investigators should seek guidance from their institutions, on issues related to institutional policies and local IRB rules, as well as local, State and Federal laws and regulations, including the Privacy Rule.

Policy for Genome-Wide Association Studies (GWAS):
NIH is interested in advancing genome-wide association studies (GWAS) to identify common genetic factors that influence health and disease through a centralized GWAS data repository. For the purposes of this policy, a genome-wide association study is defined as any study of genetic variation across the entire human genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight), or the presence or absence of a disease or condition. All applications, regardless of the amount requested, proposing a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. Data repository management (submission and access) is governed by the Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088. For additional information, see http://grants.nih.gov/grants/gwas/

Access to Research Data through the Freedom of Information Act:
The Office of Management and Budget (OMB) Circular A-110 has been revised to provide access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this funding opportunity in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award.

Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm). At the same time the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm). All investigators submitting an NIH application or contract proposal, beginning with the October 1, 2004 receipt date, are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.

Inclusion of Women And Minorities in Clinical Research:
It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.

Inclusion of Children as Participants in Clinical Research:
The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them.

All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).

Required Education on the Protection of Human Subject Participants:
NIH policy requires education on the protection of human subject participants for all investigators submitting NIH applications for research involving human subjects and individuals designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

Human Embryonic Stem Cells (hESC):
Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-116.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s) to be used in the proposed research.

NIH Public Access Policy Requirement:
In accordance with the NIH Public Access Policy (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html) investigators must submit or have submitted for them their final, peer-reviewed manuscripts that arise from NIH funds and are accepted for publication as of April 7, 2008 to PubMed Central (http://www.pubmedcentral.nih.gov/), to be made publicly available no later than 12 months after publication. As of May 27, 2008, investigators must include the PubMed Central reference number when citing an article in NIH applications, proposals, and progress reports that fall under the policy, and was authored or co-authored by the investigator or arose from the investigator’s NIH award. For more information, see the Public Access webpage at http://publicaccess.nih.gov/.

Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule", on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR).

Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. For publications listed in the appendix and/or Progress report, internet addresses (URLs) must be used for publicly accessible on-line journal articles. Unless otherwise specified in this solicitation, Internet addresses (URLs) should not be used to provide any other information necessary for the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.

Healthy People 2010:
The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This FOA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372. Awards are made under authority of the Superfund Amendments and Reauthorization Act of 1986, Title 1, Section III, and Title II, Section 209 (Public Law 99-499); and 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 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

Loan Repayment Programs:
NIH encourages applications for educational loan repayment from qualified health professionals who have made a commitment to pursue a research career involving clinical, pediatric, contraception, infertility, and health disparities related areas. The LRP is an important component of NIH's efforts to recruit and retain the next generation of researchers by providing the means for developing a research career unfettered by the burden of student loan debt. Note that an NIH grant is not required for eligibility and concurrent career award and LRP applications are encouraged. The periods of career award and LRP award may overlap providing the LRP recipient with the required commitment of time and effort, as LRP awardees must commit at least 50% of their time (at least 20 hours per week based on a 40 hour week) for two years to the research. For further information, please see: http://www.lrp.nih.gov.