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U.S. Environmental Protection Agency
Office of Research and Development
National Center for Environmental Research
Science to Achieve Results (STAR) Program

CLOSED - FOR REFERENCES PURPOSES ONLY

Computational Toxicology Centers: Development Of Predictive Environmental And Biomedical Computer-Based Simulations And Models

This is the initial announcement of this funding opportunity.

Funding Opportunity Number: EPA-G2007-STAR-D1

Catalog of Federal Domestic Assistance (CFDA) Number: 66.509

Solicitation Opening Date: February 7, 2007
Solicitation Closing Date: June 12, 2007 4:00 pm Eastern Time

Eligibility Contact: Tom Barnwell (barnwell.thomas@epa.gov); phone: 202-343-9862
Electronic Submissions: Thomas O'Farrell (o'farrell.thomas@epa.gov); 703-347-8085
Technical Contacts:
Pasky Pascual (pascual.pasky@epa.gov); phone: 703-347-8056
Deborah Segal (segal.deborah@epa.gov); phone: 703-347-8528

Table of Contents:
SUMMARY OF PROGRAM REQUIREMENTS
Synopsis of Program
Award Information
Eligibility Information
Application Materials
Agency Contacts
I. FUNDING OPPORTUNITY DESCRIPTION
A. Introduction
B. Background
C. Authority and Regulations
D. Specific Areas of Interest/Expected Outputs and Outcomes
E. References
F. Special Requirements
II. AWARD INFORMATION
III. ELIGIBILITY INFORMATION
A. Eligible Applicants
B. Cost Sharing
C. Other
IV. APPLICATION AND SUBMISSION INFORMATION
A. Internet Address to Request Application Package
B. Content and Form of Application Submission
C. Submission Dates and Times
D. Funding Restrictions
E. Submission Instructions and Other Submission Requirements
V. APPLICATION REVIEW INFORMATION
A. Peer Review
B. Programmatic Review
C. Funding Decisions
VI. AWARD ADMINISTRATION INFORMATION
A. Award Notices
B. Disputes
C. Administrative and National Policy Requirements
VII. AGENCY CONTACTS

Access Standard STAR Forms (http://www.epa.gov/ncer/rfa/forms/)
View research awarded under previous solicitations (http://www.epa.gov/ncer/rfa/archive/grants/)

SUMMARY OF PROGRAM REQUIREMENTS

Synopsis of Program:
The U.S. Environmental Protection Agency (EPA), as part of its Science to Achieve Results (STAR) program, is seeking applications proposing to develop in silico modeling applications of biological systems in areas as diverse as receptor–ligand interactions in cell signaling, simulated organ dysfunction (e.g., heart, liver, kidney), and systemic response to environmental toxicants and pollutants. The STAR program is issuing this request for applications (RFA) for research that will seek to apply high-performance computing technologies and theoretical mathematical techniques to facilitate the development of a predictive capacity for estimating outcomes or risk associated with particular toxicity processes as a result of environmental exposure to pollutants and toxicants. The development of predictive computational modeling of whole biological systems from cells to organs has the potential to address environmental and human health factors with broad scientific and environmental or economic impacts. The overall goal of the computational research effort supported by the U.S. EPA is to develop the use of computational approaches to provide tools for quantitative risk assessment and more efficient strategies for prioritizing chemicals for screening and testing. Through the support of the computational toxicology initiative, EPA will fund research that addresses data gaps in environmental and human health risk assessment and will strengthen the ability of predictive scientific data to guide sound future scientific policy, decisions, and research. To support the development of predictive mathematical models and simulations, the Computational Toxicology Centers will be funded for up to 4 years. A research Center is operated through a university, non-profit, or governmental entity to conduct complex, long-term, and collaborative research projects using multi-disciplinary approaches. A research Center is a consortium of investigators who will work together to address the investigational areas being solicited. (see eligibility information section for eligible applicants)

To obtain optimal impact from the STAR computational toxicology resources only two Centers that address problems and research needs facing the U.S. in human health and environmental risk assessment will be awarded. The Centers should be comprised of multiple scientists with different backgrounds and capabilities, from a single or a variety of institutions, working collaboratively. The Centers will also be expected to foster the professional development of junior faculty as well as the training of students and postdoctoral fellows in the use of high performance computing.

Award Information:
Anticipated Type of Award: Grant or Cooperative Agreement
Estimated Number of Awards: Approximately 2 awards
Anticipated Funding Amount: Approximately $6.8 million total for all awards
Potential Funding per Award: Up to a total of $3,400,000, including direct and indirect costs, with a maximum duration of 4 years. Cost-sharing is not required. Proposals with budgets exceeding the total award limit will not be considered.

Eligibility Information:
Public nonprofit institutions/organizations (includes public institutions of higher education and hospitals) and private nonprofit institutions/organizations (includes private institutions of higher education and hospitals) located in the U.S., state and local governments, Federally Recognized Indian Tribal Governments, and U.S. territories or possessions are eligible to apply. See full announcement for more details.

Application Materials:
You may submit either a paper application or an electronic application (but not both) for this announcement. The necessary forms for submitting a STAR application will be found on the National Center for Environmental Research (NCER) web site, http://www.epa.gov/ncer/rfa/forms/. To apply electronically, you must use the application package available at Grants.gov (see “Submission Instructions for Electronic Applications” in Section IV). If your organization is not currently registered with Grants.gov, you need to allow approximately one week to complete the registration process to apply electronically. This registration, and electronic submission of your application, must be performed by an authorized representative of your organization.

Agency Contacts:

Eligibility Contact: Tom Barnwell (barnwell.thomas@epa.gov); phone: 202-343-9862
Electronic Submissions: Thomas O'Farrell (o'farrell.thomas@epa.gov); 703-347-8085
Technical Contacts:
Pasky Pascual (pascual.pasky@epa.gov); phone: 703-347-8056
Deborah Segal (segal.deborah@epa.gov); phone: 703-347-8528

I. FUNDING OPPORTUNITY DESCRIPTION

A. Introduction
The U.S. Environmental Protection Agency (EPA) is interested in the development and application of novel technologies, derived from computational chemistry, molecular biology, systems biology, and bioinformatics in toxicological risk assessment. In assessing risk associated with exposure to a chemical or other environmental stressor, a number of scientific uncertainties exist along a “source-to-adverse outcome” continuum, beginning with the presence of the chemical in the environment, the uptake and distribution of the chemical in the organism or environment, the presence of the active chemical at a systemic target site, and the series of biological events that lead to the manifestation of an adverse human health or ecological outcome that can be used for risk assessment. The “Human Health Research Strategy” (PDF) (67 pp, 1.50 MB, about PDF) and “Ecological Research Strategy” (PDF) (130 pp, 1.3 MB) developed by EPA’s Office of Research and Development (ORD) describe the scientific uncertainties and some of the multidisciplinary approaches that are needed to build linkages between exposure, dose and effects.

ORD’s research program in Computational Toxicology seeks to use emerging technologies to improve risk assessment and reduce uncertainties in this source-to-adverse outcome continuum (http://www.epa.gov/comptox/comptox_framework.html). The strategic objectives of the Computational Toxicology Initiative are:

  1. Develop improved linkages across the source-to-outcome continuum, including the areas of chemical transformation and metabolism, better diagnostic/prognostic molecular markers, improved dose metrics, characterization of toxicity pathways, metabonomics, systems biology approaches, modeling frameworks, and uncertainty analysis.
  2. Provide improved predictive models for hazard identification, including the areas of Quantitative Structure Activity Relationships (QSARs) and other computational approaches, improved pollution prevention strategies, and high through-put screening approaches.
  3. Apply computational toxicology to enhance quantitative risk assessment in the areas of dose-response assessment, cross-species extrapolation, and chemical mixtures.

Computational modeling of whole biological systems from cells to organs is gaining momentum in cell biology and disease studies. Advancements in the ability to implement and develop advanced mathematical approaches to modeling biological systems are a key element in facilitating the development of a predictive capacity for estimating outcomes or risk associated with particular disease processes and environmental toxicants or pollutants. Therefore, we seek to fund research in computer science and mathematical research areas that address the environmental problems and research needs facing the U.S. by applying high-performance computing techniques and resources to in silico multi-scale modeling applications at the cellular, organ, and system-wide level.

B. Background
The mission of the U.S. Environmental Protection Agency is to safeguard public health and the environment from harmful effects that may be caused by exposure to pollutants in the air, water, soil, and food. Protecting human health and the environment carries with it the challenge of assessing the risk that is posed by tens of thousands of chemicals. The large number of chemicals that the Agency must evaluate and the many different statutes under which chemicals are regulated has traditionally made it impossible for the Agency to evaluate every chemical with the most rigorous testing strategies. Instead, standard toxicity tests have been conducted on only a small number of chemicals.

In November of 2005 the U.S. EPA funded the STAR Environmental Bioinformatics Research Centers to foster research that involves the design, development, and application of computer systems and software that enable scientists to explore high-throughput data from gene expression microarray experiments, mass spectrometry-based peptide and protein identification experiments, and various quantitative measures of metabolic states and metabolites.

Examples of potential modeling project topics of interest to environmental and human health scientists are listed below:

  1. Multiscale/multilevel modeling of biological processes and molecular interactions; development of models that combine components with different length and time scales (biochemical networks to cell behavior to tissue morphology). For instance; a "complete" cell model would track the time evolution levels of RNA, protein and other chemical species.
  2. Full system modeling /systems biology modeling; many computational models have been developed to cover a single subsystem or pathway (metabolic, regulatory, signaling...). However, toxic effects may arise downstream of the initial site of action of an input chemical. To recognize this situation more readily, it would be useful to create models that link unit networks into whole system models.
  3. Development of qualitative as well as quantitative system models / computational analysis methods; for systems modeling, research on qualitative models could be envisioned as a stage in model development where the topology of the model is specified but data are not available to parameterize the fully quantitative model. Development efforts could focus on determining the threshold at which the topology of the qualitative model is sufficient by itself to determine quantitative model behavior.
  4. Development of methods that create, validate and use both quantitative and qualitative models as a methodology for determining network or connectivity from experimental data.

The specific Strategic Goal and Objective from EPA’s Strategic Plan that relate to this solicitation are:  Goal 4: Healthy Communities and Ecosystems, Objective 4.4: Enhance Science and Research

The EPA’s Strategic Plan can be found at www.epa.gov/ocfo/plan/2006/entire_report.pdf (184 pp, 11.56 MB, about PDF).

C. Authority and Regulations
The authority for this RFA and resulting awards is contained in the Toxic Substances Control Act, Section 10, 15 U.S.C. 2609; Federal Insecticide, Fungicide, and Rodenticide Act, Section 20, 7 U.S.C. 136r; Clean Air Act, Section 103, 42 U.S.C. 7403; and the Clean Water Act, Section 104, 33 U.S.C.

For research with an international aspect, the above statutes are supplemented, as appropriate, by the National Environmental Policy Act, Section 102 (2)(F).

D. Specific Research Areas of Interest/Expected Outputs and Outcomes
Note to applicant:  The term “output” means an environmental activity or effort, and associated work products, related to a specific environmental goal(s), (e.g., testing a new methodology), that will be produced or developed over a period of time under the agreement. The term “outcome” means the result, effect, or consequence that will occur from the above activit(ies) that is related to an environmental, behavioral, or health-related objective.

The U.S. EPA, as part of its STAR program, is seeking applications proposing to develop in silico simulation and modeling applications of biological systems in areas as diverse as receptor–ligand interactions in cell signaling, simulated organ dysfunction (e.g., heart, liver, kidney), and systemic response to environmental toxicants and pollutants. The STAR program is issuing this Request for Applications (RFA) for research that will seek to apply high-performance computing technologies and theoretical mathematical techniques to facilitate the development of a predictive capacity for estimating outcomes or risk associated with particular toxicity processes as a result of environmental exposure to pollutants and toxicants. Risk assessors need to better understand chemical behavior in natural and chemically-impacted ecosystems and in biological systems to carry out the increasingly complex array of exposure and risk assessments necessary to protect public health. Trends in decision making strategies also require greater reliance on predictive modeling. Therefore the development of mechanistic models for the purpose of building the ability of environmental and human health scientists to better assess and communicate risks to human health, risks to ecological systems, and risks to biological systems is a necessary outcome for this process to move forward.

This STAR Computational Toxicology RFA seeks to fund Computational Modeling Centers to facilitate the understanding of cell behavior by creating sophisticated mathematical- and computer-based models. For the purpose of this RFA, the term Computational Toxicology is defined as the application of mathematical and computer models to predict adverse effects and to better understand the mechanism(s) through which a chemical induces harm. EPA seeks to fund research that will develop complex computational models and simulations that use a broad range of biological information, including high-throughput genomics and proteomics data. Further development of advanced, mechanistic models will allow scientists to create new hypotheses as well as analyze the ever-expanding mass of biological data.

Through its application, computational modeling can provide validation as well as predictive analysis for experiments, which due to research limitations (whether as a result of time, funding, logistics, etc.) cannot otherwise be performed. In biomedicine, simulation models of biological systems now contain sufficient detail, not only to reconstruct normal functions, but also to reconstruct major disease states. As these models become more widely developed, simulation modeling will aid the targeting of current knowledge gaps, reveal insights that will bridge those gaps, and provide a research tool for selecting critical factors from multiple simulated experiments for real experimental design. Through network modeling of biological systems scientists will improve the understanding of how cells sense their environment and respond to environmental stimuli as well as guide scientific decision makers and statutory regulations. Therefore through the application of today's powerful computational platforms to biological research we are now able to begin to identify, analyze, and compare the fundamental biological components and processes that result from exposures to environmental toxicants and pollutants and their predicted impact on the human body and the ecosystem.

The outcome of this model development is the potential to increase the understanding and ability to predict the cumulative risk effects of, for example, the environmental exposure of an organism to multiple chemicals as opposed to a single chemical analysis. The need for multimedia, multistressor, multipathway assessments (from both the human and ecological perspectives) over broad spatial and temporal scales places a high priority both on the further elucidation of chemical behavior and on the development of new modeling tools. Because of the inherent complexity of real biological systems, development and analysis of computational models based directly on experimental data are necessary to achieve this understanding.

The output will include the creation of simulation models for predicting toxicity pathways, mechanisms, and health impacts as a result of environmental exposures. Ultimately, models will have an impact on understanding human health and strategies for environmental health risk management. The overall goal of the computational research effort supported by the U.S. EPA is to develop the use of computational approaches and to provide to the public tools for quantitative risk assessment and more efficient strategies for prioritizing chemicals for screening and testing.

Through this RFA, EPA seeks to fund centers to conduct research that will synthesize mathematical and computational simulations and models of biological systems. Models and simulations that capture knowledge through the explicit representation of dynamic biochemical and biophysical processes are desired. This research will also include the validation and application of these simulations and models in order to further our understanding of complex biological system functions in response to environmental exposures to toxicants. Proposals are expected to include multiple investigators working in collaboration. A proposed center must have a Center Director who will have the responsibility of ensuring that resources are utilized in an optimal way and that efforts of each team are focused on their proposed research project. The Center Director will also be responsible for reports and reviews of the teams’ research progress. Centers are obligated to engage the expertise of multidisciplinary teams focused on the basic and applied research projects needed to solve the Nation's environmental problems. The teams should each have their own unique research focus, for the purpose of this RFA denoted as an Investigational Area, and be balanced in such a manner to make the most effective use of available resources in accomplishing their proposed objectives.

Each Center should encompass multiple research teams, with each team’s Investigational Area focus detailed in a Research Plan (for general guidance see “Research Plan” in section IV.B.7.a.). To be responsive to the requirements of this RFA, a Center must be comprised of a minimum of two Investigational Areas, each with its own research team (2-5 proposed Investigational Areas are expected for each Center). For each Investigational Area proposed, successful applications will address each of the following:

  • Development of Mathematical Models
  • Priorities of Model Development
  • Standard Model Formats and Computational Approaches

Researchers are encouraged to take advantage of existing biological data. However, limited data generation for the purpose of model validation is permissible under this RFA. Successful research grant applications will be those driven by computational and mathematical principle, model design, and validation.

Development of Mathematical Models

For each Investigational Area, a Center should propose research that develops in silico modeling applications for biological processes such as receptor–ligand interactions in cell signaling, downstream signaling networks, developmental processes, and simulated organ dysfunction (e.g., heart, liver, lungs), and be applicable to human and environmental toxicity studies and risk assessments. Such systems should seek to couple models across large ranges of length- and time-scales in describing complex biological systems through the use of hierarchical and hybrid multiscale modeling. Multiscale models that couple behavior at the molecular biological level to that at the cellular level are desired, to inform the process for calculating many unknown parameters as well as investigating the effects of small changes at the biomolecular level (e.g. network analysis of cell signaling, metabolic pathways, or genetic mutations due to the presence of an environmental pollutant or toxicant). Modeling methods proposed are expected to bring benefit to environmental and human health risk assessments.

Priorities of Model Development

Models should address issues of biological importance and be relevant to toxicity pathways or processes activated in response to exposures to environmental toxicants. Computational approaches to building models and simulations of biological systems may include, but are not limited to, the following:

  1. Models of biological networks including: signal transduction; biochemical networks; gene regulatory networks; metabolic networks; intracellular dynamics; cell structural dynamics; cell communication and tissue physiology.
  2. Models including finer scale details such as protein structure and behavior, and electronic effects.
  3. Development of algorithmic methods for specification of Physiologically Based Pharmacokinetic (PBPK) models that take into account the chemical structure of potentially toxic substances or stressors. This could include, for instance, development of algorithms for partition coefficients, metabolism, absorption through skin and from the GI tract, or pulmonary absorption.

For each Investigational Area, the proposal should address how each of the three components of model development below will be undertaken.

  1. Model Complexity:
    1. Multiscale/multilevel modeling of biological processes and molecular interactions.
    2. Full system modeling, i.e. the inclusion of multiple processes at the each length scale or level.
    3. Qualitative as well as quantitative system models and computational analysis methods.
    4. Methods that create, validate, and use both quantitative and qualitative models as a methodology for determining network structure or connectivity from experimental data.
  2. Model Parameterization:
    1. Model Parameterization / Validation; a key issue in using predictive models is the problem of determining models parameters such as rate constants, reaction orders, and initial conditions. Development of improved methods for determining these parameters from experimental data or detailed computations is needed.
    2. Model stability; many models can produce the same output behavior. Models may have different or identical topology but different parameters and still yield close to identical dynamic behavior. This is an issue related to model parameterization, and should be investigated because it will impact the ultimate validity and extensibility of a model.
    3. Research on characterization of the uncertainty in biologically based models and of models based on default assumptions. The purpose of this research would be to provide better tools for understanding in a rigorous, reproducible manner how to rank model uncertainty for models incorporating different amounts of biological and toxicological information. For example, given two or more models for the response to a toxicant, the preferred model is the one whose predictions are least uncertain (i.e., the model in whose predictions we have the most confidence).
  3. Validation / Prediction using Experimental Data:
    1. Integration of computational research with experimental data from ongoing experimental work, preferably on pathways/chemicals/endpoints relevant to toxicity risk assessment.
    2. Scripting/applying techniques for the rapid development, adaptation, and validation of the mathematical methods and models against experimental data.
    3. Computational evaluation of predicted pathways (e.g. approaches like sensitivity analysis) against known biological pathways.

In addition, as part of their research goals, for each Investigational Area, applicants are encouraged to address one or both of the following components:

  1. Informatics Issues: Development of informatics tools for integrating, organizing, managing and providing open access to disparate biological experimental and reference biological data (not database development).
  2. Visualization: Development of graphical interfaces to allow the visualization of the output of complex models and simulations.

Proposals should include not only method, simulation, and model development, but also demonstrate the link between proposed models and simulations to areas of interest including, but not limited to: developmental biology, metabolism, neurology, systems biology, and tumor initiation and growth. Proposed models and simulations should address toxicology issues which directly affect human and ecological health.

*Note to applicants: Each center should have, or obtain a commitment for, access to experimental data sets that will be used to parameterize and/or validate the models being developed. In conducting its research, the Center must demonstrate a willingness to use data generated by EPA and other institutions or organizations, as the basis for the development and application of computational models. It is not expected that the Center will be responsible for the generation of new biological data, but rather would be focused on advancing the science of ecological and human health risk assessment through the use of existing databases or data available through collaborators (such as academic institutions, EPA, NIEHS, DOE, CDC, etc.).

[Examples of several published models are given in Section E. (References) of this RFA (Albert and Othmer 2003; Alarcon, Byrne et al. 2004; Friedman 2004; King, Garrett et al. 2005; Bookout, Jeong et al. 2006)]

Standard Model Formats and Computational Approaches

For computational modeling to become more widely used in biological research, researchers must be able to exchange their results. Therefore, for each Investigational Area, the proposal should also address how teams will: (1) define agreed-upon standards for model curation, (2) define agreed-upon vocabularies for annotating models with connections to biological data resources, and (3) provide free publicly-accessible computational models.

  • Data / model exchange: The center should be prepared to exchange data and models in standard (but still evolving) formats, such as SBML.
  • In addition to the use of community developed model exchange formats, a strategy should be outlined for re-using existing public domain software and plans for public release of software modules, e.g. bioconductor, bioperl, biolisp, etc.
  • Modeling and simulation of biomolecular systems is very computationally intensive; therefore the Center should detail allocations of computer time and identification of computational support for each Investigational Area.

E. References

Barbara Di Ventura, Caroline Lemerle, Konstantinos Michalodimitrakis, Luis Serrano (2006). “From in vivo to in silico biology and back.” Nature 443, 527-533. Available at: http://www.nature.com/nature/journal/v443/n7111/full/nature05127.html exit EPA

Alarcon, T., H. M. Byrne, et al. (2004). "Towards whole-organ modelling of tumour growth." Prog Biophys Mol Biol 85(2-3): 451-72.

Albert, R. and H. G. Othmer (2003). "The topology of the regulatory interactions predicts the expression pattern of the segment polarity genes in Drosophila melanogaster." J Theor Biol 223(1): 1-18.

Bookout, A. L., Y. Jeong, et al. (2006). "Anatomical profiling of nuclear receptor expression reveals a hierarchical transcriptional network." Cell 126(4): 789-99.

Friedman, N. (2004). "Inferring cellular networks using probabilistic graphical models." Science 303(5659): 799-805.

King, R. D., S. M. Garrett, et al. (2005). "On the use of qualitative reasoning to simulate and identify metabolic pathways." Bioinformatics 21(9): 2017-26.

F. Special Requirements

Agency policy prevents EPA technical staff and managers from providing individual applicants information that may create an unfair competitive advantage. Consequently, EPA employees will not review, comment, advise, provide technical assistance to applicants preparing applications in response to EPA RFA's, endorse an application or discuss in any manner how the Agency will apply the published evaluation criteria for this competition.

Groups of two or more eligible applicants may choose to form a consortium and submit a single application for this assistance agreement. The application must identify which organization will be the recipient of the assistance agreement and which organizations(s) will be sub-awardees of the recipient.

The application must include a plan (see “Data Plan” in section IV.B.7.c.) to make available to the public all data generated from observations, analyses, or model development (primary data) and any secondary (or existing) data used under an agreement awarded from this RFA. The data must be available in a format and with documentation such that they may be used by others in the scientific community.

II. AWARD INFORMATION

It is anticipated that a total of approximately $6.8 million will be awarded under this announcement, depending on the availability of funds and quality of applications received. The EPA anticipates funding approximately two Grants or Cooperative Agreements under this RFA. Requests for amounts in excess of a total of $3,400,000, including direct and indirect costs, will not be considered. The total project period requested in an application submitted for this RFA may not exceed four years. The EPA reserves the right to reject all applications and make no awards, or make fewer awards than anticipated, under this RFA. The EPA reserves the right, consistent with Agency policy and without further competition, to make additional awards under this RFA if additional funding becomes available. Any additional selections for awards will be made no later than four months after the original selection decisions.

EPA may fund both grants and cooperative agreements under this announcement.

Under a grant, EPA scientists and engineers are not permitted to be substantially involved in the execution of the research. However, EPA encourages interaction between its own laboratory scientists and grant Principal Investigators after the award of an EPA grant for the sole purpose of exchanging information in research areas of common interest that may add value to their respective research activities. This interaction must be incidental to achieving the goals of the research under a grant. Interaction that is “incidental” does not involve resource commitments.

Where appropriate, based on consideration of the nature of the proposed project relative to the EPA’s intramural research program and available resources, the EPA will fund cooperative agreements under this announcement. When addressing a research question/problem of common interest, collaborations between scientists and the institution’s principal investigators are permitted under a cooperative agreement. These collaborations may include data and information exchange, providing technical input to experimental design and theoretical development, coordinating extramural research with in-house activities, the refinement of valuation endpoints, and joint authorship of journal articles on these activities. Proposals should not identify EPA cooperators or interactions; specific interactions between EPA’s investigators and those of the prospective recipient for cooperative agreements will be negotiated at the time of award.

III. ELIGIBILITY INFORMATION

A. Eligible Applicants
Public nonprofit institutions/organizations (includes public institutions of higher education and hospitals) and private nonprofit institutions/organizations (includes private institutions of higher education and hospitals) located in the U.S., state and local governments, Federally Recognized Indian Tribal Governments, and U.S. territories or possessions are eligible to apply. Profit-making firms are not eligible to receive assistance agreements from the EPA under this program.

Eligible nonprofit organizations include any organizations that meet the definition of nonprofit in OMB Circular A-122. However, nonprofit organizations described in Section 501(c) (4) of the Internal Revenue Code that lobby are not eligible to apply.

National laboratories funded by Federal Agencies (Federally-Funded Research and Development Centers, “FFRDCs”) may not apply. FFRDC employees may cooperate or collaborate with eligible applicants within the limits imposed by applicable legislation and regulations. They may participate in planning, conducting, and analyzing the research directed by the applicant, but may not direct projects on behalf of the applicant organization. The institution, organization, or governance receiving the award may provide funds through its assistance agreement from the EPA to an FFRDC for research personnel, supplies, equipment, and other expenses directly related to the research. However, salaries for permanent FFRDC employees may not be provided through this mechanism.

Federal Agencies may not apply. Federal employees are not eligible to serve in a principal leadership role on an assistance agreement, and may not receive salaries or augment their Agency’s appropriations in other ways through awards made under this program.

The applicant institution may enter into an agreement with a Federal Agency to purchase or utilize unique supplies or services unavailable in the private sector. Examples are purchase of satellite data, census data tapes, chemical reference standards, analyses, or use of instrumentation or other facilities not available elsewhere. A written justification for federal involvement must be included in the application. In addition, an appropriate form of assurance that documents the commitment, such as a letter of intent from the Federal Agency involved, should be included.

Potential applicants who are uncertain of their eligibility should contact Tom Barnwell (barnwell.thomas@epa.gov) in NCER, phone 202-343-9862.

B. Cost-Sharing
Institutional cost-sharing is not required.

C. Other
Applications must substantially comply with the application submission instructions and requirements set forth in Section IV of this announcement or they will be rejected. In addition, where a page limitation is expressed in Section IV with respect to parts of the application, pages in excess of the page limit will not be reviewed. Applications must be received by the EPA, or Grants.gov, on or before the solicitation closing date and time in Section IV of this announcement or they will be returned to the sender without further consideration. Also, applications exceeding the funding limits or project period term described herein will be returned without review. Further, applications that fail to demonstrate a public purpose of support or stimulation (e.g., by proposing research which primarily benefits a Federal program or provides a service for a Federal agency) will not be funded.

To ensure that proposals address priority areas of research, studies will be considered non-responsive if they propose to conduct extensive molecular biology research or other laboratory-based research or data generation. Researchers are encouraged to form partnerships to take advantage of existing biological data, however limited data generation for the purpose of model validation is permissible under this RFA. Successful research grant applications will be those driven by computational and mathematical principle, model design, and validation.

In addition, each application must address the following:

  1. Computational Capabilities
    1. Describe the computational and network resources available as well as the specific types of statistical and bioinformatic approaches that exist within the organization and how such approaches can be applied to the selected Investigative Areas.
    2. Highlight what new developments in computational toxicology analysis, database development, and other areas of de novo programming are proposed, as well as areas where existing computational and database resources will be utilized.
  2. The Center must be composed of at least two Investigational Areas, each of which must be completely described according to the APPLICATION AND SUBMISSION INFORMATION section of this RFA (see "Research Plan" in section IV.B.7.a.). Each Area is permitted a 15-page description. Individual project descriptions must explain how the Investigational Area fits into the overall Center program and relates to other projects in the proposal.
  3. The Center must have a Center Director.
  4. The Center must have an Administrative Core Unit.
  5. The application must include a "Center Integration Plan."
  6. The Center must submit a Communication and Public Outreach Strategy.
  7. New Investigators - To attract new investigators into the application of computer science and mathematics research to biological systems, the Center must partially support at least one newly recruited Center scientist. Up to $70,000 per year, direct cost, may be used for each newly required Center scientist to provide up to 75 percent salary support, technical support, equipment, and supplies. Recruitment of women, minorities, and persons with disabilities is strongly encouraged. To the extent possible, the types of individuals sought and their expected roles should be described in the application if specific individuals have not been identified.
  8. Postdoctoral training - the Center must support a minimum of two postdoctoral scientists (at least one of whom is to be newly recruited) and provide a research environment in leading-edge informatics/computational tools or approaches, as well as a structured mentoring and career development opportunity (see "Center Description" in section IV.B.5.).

To be eligible for funding consideration, a project's focus must consist of activities within the statutory terms of EPA's financial assistance authorities; specifically, the statute(s) listed in I.C. above. Generally, a project must address the causes, effects, extent, prevention, reduction, and elimination of air pollution, water pollution, solid/hazardous waste pollution; toxic substances control; or pesticide control. These activities should relate to the gathering or transferring of information or advancing the state of knowledge. Proposals should emphasize this "learning" concept, as opposed to "fixing" an environmental problem via a well-established method. Proposals relating to other topics which are sometimes included within the term "environment" such as recreation, conservation, restoration, protection of wildlife habitats, etc., must describe the relationship of these topics to the statutorily required purpose of pollution prevention and/or control.

Applications deemed ineligible for funding consideration will be notified within fifteen calendar days of the ineligibility determination.

IV. APPLICATION AND SUBMISSION INFORMATION

You may submit either a paper application or an electronic application (but not both) for this announcement. Instructions for both types of submission follow. If not otherwise marked, instructions apply to both types of submissions.

A. Internet Address to Request Application Package
For paper applications, forms and instructions can be found on the NCER web site: http://www.epa.gov/ncer/rfa/forms/.

For electronic applications, use the application package available at Grants.gov (see “Submission Instructions for Electronic Applications”). Note: With the exception of the Budget form (available at http://www.epa.gov/ncer/rfa/forms); all necessary forms are included in the electronic application package.

For both paper and electronic applications, an email will be sent by NCER to the Principal Investigator and the Administrative Contact (see below) to acknowledge receipt of the application and transmit other important information. The email will be sent from receipt.application@epa.gov; emails to this address will not be accepted. If you do not receive an email acknowledgment within 30 days of the submission closing date, immediately inform the Eligibility Contact shown in this solicitation. Failure to do so may result in your application not being reviewed.  See “Submission Instructions for Electronic Applications” for additional information regarding acknowledgment of receipt of electronically submitted applications. Please note: Due to often-lengthy delays in delivery, it is especially important that you monitor NCER’s confirmation of receipt of your application when using regular mail.

B. Content and Form of Application Submission
The application is made by submitting the materials described below. It is essential that the application contain all information requested and be submitted in the formats described.

  1. Standard Form 424

    The applicant must complete Standard Form 424. This form will be the first page(s) of the application. Instructions for completion of the SF424 are included with the form. (However, note that EPA requires that the entire requested dollar amount appear on the 424, not simply the proposed first year expenses.) The form must contain the original (or electronic) signature of an authorized representative of the applying institution.

    Applicants are required to provide a "Dun and Bradstreet Data Universal Numbering System" (DUNS) number when applying for federal grants or cooperative agreements. Organizations may receive a DUNS number by calling 1-866-705-5711 or by visiting the web site at http://www.dnb.com exit EPA.

    Executive Order 12372, "Intergovernmental Review of Federal Programs," applies to most EPA programs and assistance agreements, unless the program or assistance agreement supports tribal, training/fellowships (other than Wastewater and Small Water Systems Operator training programs), and research and development (with some exceptions). The SF424 refers to this Executive Order requirement. National research programs are generally exempt from review unless the proposals (a) require an Environmental Impact Statement (EIS), or (b) do not require an EIS but will be newly initiated at a particular site and require unusual measures to limit the possibility of adverse exposure or hazard to the general public, or (c) have a unique geographic focus and are directly relevant to the governmental responsibilities of a State or local government within that geographic area. To determine whether their state participates in this process, and how to comply, applicants should consult http://www.whitehouse.gov/omb/grants/spoc.html.

  2. Key Contacts

    The applicant must complete the "Key Contacts" form as the second page of the application: a Key Contacts continuation page is also available at http://www.epa.gov/ncer/rfa/forms. The Key Contacts form should also be completed for major sub-agreements (i.e., primary co-investigators). Please make certain that all contact information is accurate.

  3. Table of Contents

    Provide a list of the major subdivisions of the application indicating the page number on which each section begins.

  4. Abstract (1 page)

    The abstract is a very important document in the review process. Therefore, it is critical that the abstract accurately describes the research being proposed and conveys all the essential elements of the research. Also, the abstracts of applications that receive funding will be posted on the NCER web site.

    The abstract should include the information described below (a-h). Examples of abstracts for current grants may be found on the NCER web site.

    1. Funding Opportunity Title and Number for this proposal.
    2. Project Title: Use the exact title of your project as it appears in the application. The title must be brief yet represent the major thrust of the project. Because the title will be used by those not familiar with the project, strike a balance between highly technical words and phrases and more commonly understood terminology. Do not use general phrases such as "research on."
    3. Investigators: List the Principal Investigator, then the names and affiliations of each co-investigator who will significantly contribute to the project. Provide a web site URL or an email contact address for additional information.
    4. Institution: In the same order as the list of investigators, list the name, city and state of each participating university or other applicant institution. The institution applying for assistance must be clearly identified.
    5. Project Period and Location: Show the proposed project beginning and ending dates, and the geographical location(s) where the work will be conducted.
    6. Project Cost: Show the total dollars requested from the EPA (include direct and indirect costs for all years).
    7. Project Summary: Provide three subsections addressing: (1) the objectives of the study (including any hypotheses that will be tested), (2) the experimental approach to be used (a description of the proposed project), and (3) the expected results of the project and how it addresses the research needs identified in the solicitation, including the estimated improvement in risk assessment or risk management that will result from successful completion of the proposed work.
    8. Supplemental Keywords: Without duplicating terms already used in the text of the abstract, list keywords to assist database searchers in finding your research. A list of suggested keywords may be found at: http://www.epa.gov/ncer/rfa/forms.
  5. Center Description (5 pages)

    Applications should describe the overall goals, objectives, and approach for the Center, including how the Center will pursue a multidisciplinary and thematic approach to the problems to be investigated. The structure of the Center's proposed postdoctoral training and mentorship programs should be described herein; this must include a description of career development opportunities and training provided to the postdoctoral fellows in addition to their research activities.

    This description must not exceed five (5) consecutively numbered (bottom center), 8.5x11-inch pages of single-spaced, standard 12-point type with 1-inch margins. While these guidelines establish the minimum type size requirements, applicants are advised that readability is of paramount importance and should take precedence in selection of an appropriate font for use in the proposal.

  6. Administrative Core Unit (10 pages)

    Applications must have an Administrative Core Unit, which provides overall oversight, coordination and integration of the Center's activities. A Center Integration Plan describing how the program will be integrated internally must be submitted as part of the Administrative Core description. The Center's Integration Plan, at a minimum, should indicate how programmatic and sub-contracting decisions will be made; how investigators from different computational disciplines and Investigational Areas within the Center will communicate on a regular basis about the development and progress of each of the Areas; how progress will be monitored; who sets priorities, and who is responsible for implementing the Integration Plan, ensuring compliance with the plan, and evaluating its effectiveness in achieving integration within the Center.

    In order to facilitate the dissemination to the scientific community of the computational models and simulations developed by the Center, the Center must develop and submit a Communication and Public Outreach Strategy. Publishing research results in scientific journals is essential; however, it is not sufficient. Plans for Center websites and other means of communicating results should be described. This communication strategy will address how the Center will work to disseminate the products of its research as well as identify envisioned applications of the models and simulations developed and the research community and public will benefit from this work.

    The description of the Administrative Core Unit must not exceed ten (10) consecutively numbered (bottom center), 8.5x11-inch pages of single-spaced, standard 12-point type with 1-inch margins. While these guidelines establish the minimum type size requirements, applicants are advised that readability is of paramount importance and should take precedence in selection of an appropriate font for use in the proposal.

  7. Research Plan, Quality Assurance Statement and References
    1. Research Plan (15 pages per Investigational Area, with a minimum of 2 Areas)

      Applications should focus on a limited number of research objectives that adequately and clearly demonstrate that they meet the RFA requirements. Explicitly state the main hypotheses that you will investigate, the data you will create or use, the analytical tools you will use to investigate these hypotheses or analyze these data, and the results you expect to achieve. Research methods must be clearly stated so that reviewers can evaluate the appropriateness of your approach and the tools you intend to use. A statement such as: "we will evaluate the data using the usual statistical methods" is not specific enough for peer reviewers.

      This description must not exceed fifteen (15) consecutively numbered (bottom center), 8.5x11-inch pages of single-spaced, standard 12-point type with 1-inch margins. While these guidelines establish the minimum type size requirements, applicants are advised that readability is of paramount importance and should take precedence in selection of an appropriate font for use in the proposal.

      The description must provide the following information:

      1. Objectives: List the objectives of the proposed research and the hypotheses being tested during the project, and briefly state why the intended research is important and how it fulfills the requirements of the solicitation. This section should also include any background or introductory information that would help explain the objectives of the study. If this application is to expand upon research supported by an existing or former assistance agreement awarded under the STAR program, indicate the number of the agreement and provide a brief report of progress and results achieved under it (one to two pages recommended).
      2. Approach/Activities: Outline the research design, methods, and techniques that you intend to use in meeting the objectives stated above (five to ten pages recommended).
      3. Expected Results, Benefits, Outputs, and Outcomes: Describe the results you expect to achieve during the project (outputs) and the potential benefits of the results (outcomes). This section should also discuss how the research results will lead to solutions to environmental problems and improve the public's ability to protect the environment and human health. A clear, concise description will help NCER and peer reviewers understand the merits of the research (one to two pages recommended).
      4. General Project Information: Discuss other information relevant to the potential success of the project. This should include facilities, personnel expertise/experience, project schedules, proposed management, interactions with other institutions, etc. Applications for multi-investigator projects must identify project management and the functions of each investigator in each team and describe plans to communicate and share data (one to two pages recommended).
      5. Appendices may be included but must remain within the 15-page limit.

    2. Quality Assurance Statement (1 to 3 pages in addition to the 15-page research plan)

      For projects involving environmental data collection or processing, conducting surveys, modeling, method development, or the development of environmental technology (whether hardware-based or via new techniques), provide a Quality Assurance Statement (QAS) regarding the plans for processes that will be used to ensure that the products of the research satisfy the intended project objectives. Follow the guidelines provided below to ensure that the QAS describes a system that complies with ANSI/ASQC E4, Specifications and Guidelines for Quality Systems for Environmental Data Collection and Environmental Technology Programs. Do not exceed three consecutively numbered, 8.5x11-inch pages of single-spaced, standard 12-point type with 1-inch margins.

      Address each section below by including the required information, referencing the specific location of the information in the Research Plan, or explaining why the section does not apply to the proposed research.

      1. Identify the individual who will be responsible for the quality assurance (QA) and quality control (QC) aspects of the research along with a brief description of this person's functions, experience, and authority within the research organization. Describe the organization's general approach for conducting quality research. (QA is a system of management activities to ensure that a process or item is of the type and quality needed for the project. QC is a system of activities that measures the attributes and performance of a process or item against the standards defined in the project documentation to verify that they meet those stated requirements.)
      2. Discuss project objectives, including quality objectives, any hypotheses to be tested, and the quantitative and/or qualitative procedures that will be used to evaluate the success of the project. Include any plans for peer or other reviews of the study design or analytical methods.
      3. Address each of the following project elements as applicable:
        1. Collection of new/primary data:
          (Note: In this case the word "sample" is intended to mean any finite part of a statistical population whose properties are studied to gain information about the whole. If certain attributes listed below do not apply to the type of samples to be used in your research, simply explain why those attributes are not applicable.)
          1. Discuss the plan for sample collection and analysis. As applicable, include sample type(s), frequency, locations, sample sizes, sampling procedures, and the criteria for determining acceptable data quality (e.g., precision, accuracy, representativeness, completeness, comparability, or data quality objectives).
          2. Describe the procedures for the handling and custody of samples including sample collection, identification, preservation, transportation, and storage, and how the accuracy of test measurements will be verified.
          3. Describe or reference each analytical method to be used, any QA or QC checks or procedures with the associated acceptance criteria, and any procedures that will be used in the calibration and performance evaluation of the analytical instrumentation.
          4. Discuss the procedures for overall data reduction, analysis, and reporting. Include a description of all statistical methods to make inferences and conclusions, acceptable error rates and/or power, and any statistical software to be used.
        2. Use of existing/secondary data (i.e., data previously collected for other purposes or from other sources):
          1. Describe or reference each analytical method to be used, any QA or QC checks or procedures with the associated acceptance criteria, and any procedures that will be used in the calibration and performance evaluation of the analytical instrumentation.
          2. Discuss the procedures for overall data reduction, analysis, and reporting. Include a description of all statistical methods to make inferences and conclusions, acceptable error rates and/or power, and any statistical software to be used.
        3. Method development:
          (Note: The data collected for use in method development or evaluation should be described in the QAS as per the guidance in section 3A and/or 3B above.)

          Describe the scope and application of the method, any tests (and measurements) to be conducted to support the method development, the type of instrumentation that will be used and any required instrument conditions (e.g., calibration frequency), planned QC checks and associated criteria (e.g., spikes, replicates, blanks), and tests to verify the method's performance.

        4. Development or refinement of models:
          (Note: The data collected for use in the development or refinement of models should be described in the QAS as per the guidance in section 3A and/or 3B above.)
          1. Discuss the scope and purpose of the model, key assumptions to be made during development/refinement, requirements for code development, and how the model will be documented.
          2. Discuss verification techniques to ensure the source code implements the model correctly.
          3. Discuss validation techniques to determine that the model (assumptions and algorithms) captures the essential phenomena with adequate fidelity.
          4. Discuss plans for long-term maintenance of the model and associated data.
        5. Development or operation of environmental technology:
          (Note: The data collected for use in the development or evaluation of the technology should be described in the QAS as per the guidance in section 3A and/or 3B above.)
          1. Describe the overall purpose and anticipated impact of the technology.
          2. Describe the technical and quality specifications of each technology component or process that is to be designed, fabricated, constructed, and/or operated.
          3. Discuss the procedure to be used for documenting and controlling design changes.
          4. Discuss the procedure to be used for documenting the acceptability of processes and components, and discuss how the technology will be benchmarked and its effectiveness determined.
          5. Discuss the documentation requirements for operating instructions/guides for maintenance and use of the system(s) and/or process(s).
        6. Conducting surveys:
          (Note: The data to be collected in the survey and any supporting data should be described in the QAS as per the guidance in section 3A and/or 3B above.)

          Discuss the justification for the size of the proposed sample for both the overall project and all subsamples for specific treatments or tests. Identify and explain the rational for the proposed statistical techniques (e.g., evaluation of statistical power).

      4. Discuss data management activities (e.g., record-keeping procedures, data-handling procedures, and the approach used for data storage and retrieval on electronic media). Include any required computer hardware and software and address any specific performance requirements for the hardware/software configuration used.

        Page allowances for the following section(s) are in addition to those allowed for the Research Plan and Quality Assurance Statement.

    3. Data Plan (2 pages in addition to the 15-page research plan)

      The application must include a plan to make all data resulting from an agreement under this RFA available in a format and with documentation/metadata such that they may be used by others in the scientific community. This includes both primary and secondary or existing data, i.e., from observations, analyses, or model development collected or used under the agreement. Applicants who plan to develop or enhance databases containing proprietary or restricted information must provide, within the two pages, a strategy to make the data widely available, while protecting privacy or property rights.

    4. References: References cited are in addition to the 15-page Research Plan limit.
  8. Budget and Budget Justification
    1. Budget

      Prepare a budget table using the guidance and form found at http://www.epa.gov/ncer/rfa/forms/, and select "All required forms." If a subaward, such as a subagreement with an educational institution, is greater than $25,000 and is included in the application, provide a separate budget and budget justification for the subaward. Include the total amount for the subaward under "Other" in the master budget. Any project containing subawards or subcontracts that constitute more than 40% of the total direct cost of the application will be subject to special review. Additional justification for use of these must be provided, discussing the need for the subaward/subcontract to accomplish the objectives of the research project.

      Please note that institutional cost-sharing is not required. However, if cost-sharing is proposed, a brief statement concerning cost-sharing should be added to the budget justification, and estimated dollar amounts must be included in the appropriate categories in the budget table.

    2. Budget Justification [2 pages in addition to the Section 5, 6, and 7 page limitations, not including additions under Nos. (6) and (7) below to support contracts and subawards]

      Describe the basis for calculating the personnel, fringe benefits, travel, equipment, supplies, contractual support, and other costs identified in the itemized budget. The budget justification should not exceed two consecutively numbered (bottom center), 8.5x11-inch pages of single-spaced, standard 12-point type with 1-inch margins.

      Budget information should be supported at the level of detail described below:

      1. Personnel: List all staff positions by title. Give annual salary, percentage of time assigned to the project, and total cost for the budget period.
      2. Fringe Benefits: Identify the percentage used and the basis for its computation.
      3. Travel: Specify the estimated number of trips, locations, and other costs for each type of travel. Explain the need for any travel, paying particular attention to travel outside the United States. Include travel funds for annual STAR program progress reviews (estimate for two days in Washington, D.C.) and a final workshop to report on results.
      4. Equipment: Identify all tangible, non-expendable personal property to be purchased that has an estimated cost of $5,000 or more per unit and a useful life of more than one year. (Personal property items with a unit cost of less than $5,000 are considered supplies.)
      5. Supplies: "Supplies" means tangible property other than "equipment." Identify categories of supplies to be procured (e.g., laboratory supplies or office supplies). Specifically identify computers to be purchased or upgraded.
      6. Contractual: Identify each proposed contract for services/analyses or consultants and specify its purpose and estimated cost. Contracts greater than $25,000 must have a separate itemized budget and budget justification, not to exceed one additional page each, included as part of the application.
      7. Other: List each item in sufficient detail for the EPA to determine the reasonableness of its cost relative to the research to be undertaken. Note that subawards, such as those with other universities for members of the research team, are included in this category. Subawards greater than $25,000 must have a separate itemized budget and budget justification, not to exceed one additional page each, included as part of the application.
      8. Indirect Costs: If indirect costs are included in the budget, indicate the approved rate and base with an explanation of how the indirect costs were calculated.
  9. Resumes

    Provide resumes for each investigator and important co-worker. The resume for each individual must not exceed two consecutively numbered (bottom center), 8.5x11-inch pages of single-spaced, standard 12-point type with 1-inch margins.

  10. Current and Pending Support

    Complete a current and pending support form (provided at http://www.epa.gov/ncer/rfa/forms) for each investigator and important co-worker. Include all supported research.

  11. Guidelines, Limitations, and Additional Requirements
    1. Letters of Intent/Letters of Support

      Letters of intent to provide resources for the proposed research or to document intended interactions are limited to one brief paragraph committing the availability of a resource (e.g., use of a person's time or equipment) or intended interaction (e.g., sharing of data, as-needed consultation) that is described in the Research Plan. Letters of intent are to be included as an addition to the budget justification documents.

      All letters that do not commit a resource vital to success of the proposal are considered letters of support. Letters of support, and letters of intent that exceed one brief paragraph, are considered part of the Research Plan and are included in the 15-page Research Plan limit.

      Note: Letters of intent or support must be part of the application; letters submitted separately will not be accepted.

    2. Funding Opportunity Number (FON)

      At various places in the application, applicants are asked to identify the FON.

      The Funding Opportunity Number for this RFA is:
      Computational Toxicology Centers: Development of Predictive Environmental and Biomedical Computer-Based Simulations and Models, EPA-G2007-STAR-D1

    3. Confidentiality

      By submitting an application in response to this solicitation, the applicant grants the EPA permission to make limited disclosures of the application to technical reviewers both within and outside the Agency for the express purpose of assisting the Agency with evaluating the application. Information from a pending or unsuccessful application will be kept confidential to the fullest extent allowed under law; information from a successful application may be publicly disclosed to the extent permitted by law.

      In accordance with 40 CFR 2.203, applicants may claim all or a portion of the application as confidential business information (for example, hypotheses or methodologies contained in the research narrative that the applicant wishes to protect from possible public disclosure). EPA will evaluate confidentiality claims in accordance with 40 CFR Part 2. Applicants must clearly mark applications or portions of applications they claim as confidential. If no claim of confidentiality is made, the EPA is not required to make an inquiry to the applicant as otherwise required by 40 CFR 2.204(c) (2) prior to disclosure.

C. Submission Dates and Times
For paper copy submissions, the original and two (2) copies of the complete application (3 in all, see E. below) must be received by NCER no later than 4:00 pm Eastern Time on the solicitation closing date. Electronic applications must be transferred to Grants.gov no later than 4:00 pm Eastern Time on the solicitation closing date. Applications received after the closing date and time will be returned to the sender without further consideration.

It should be noted that this schedule may be changed without prior notification because of factors not anticipated at the time of announcement. In the case of a change in the application closing date, a new date will be posted on the NCER web site (http://www.epa.gov/ncer/) and a modification posted on http://www.grants.gov.

Solicitation Closing Date: June 12, 2007, 4:00 pm Eastern Time for paper applications, 4:00 pm Eastern Time for Grants.gov electronic submissions.

D. Funding Restrictions
The funding mechanism for all awards issued under STAR solicitations will consist of assistance agreements from the EPA. All award decisions are subject to the availability of funds. In accordance with the Federal Grant and Cooperative Agreement Act, 31 U.S.C. 6301 et seq., the primary purpose of an assistance agreement is to accomplish a public purpose of support or stimulation authorized by federal statute, rather than acquisition for the direct benefit or use of the Agency. In issuing a grant, the EPA anticipates that there will be no substantial EPA involvement in the design, implementation, or conduct of the research. However, the EPA will monitor research progress through annual reports provided by grantees and other contacts, including site visits, with the Principal Investigator.

If you wish to submit applications for more than one STAR funding opportunity you must ensure that the research proposed in each application is significantly different from any other that has been submitted to the EPA or from any other financial assistance you are currently receiving from the EPA or other federal government agency.

Collaborative applications involving more than one institution must be submitted as a single administrative package from one of the institutions involved.

Any contracts for services or products funded with EPA financial assistance must be awarded under the competitive procurement procedures of 40 CFR Part 30 and/or Part 31. Moreover, naming a specific contractor in the application does not relieve the applicant of its obligations to comply with competitive procurement requirements. Also, the regulations contain limitations on consultant compensation.

Each proposed project must be able to be completed within the project period and with the initial award of funds. Applicants should request the entire amount of money needed to complete the project. Recipients should not anticipate additional funding beyond the initial award of funds for a specific project.

E. Submission Instructions and Other Submission Requirements
You may submit either a paper application or an electronic application (but not both) under this announcement.

  1. Submission Instructions for Paper Applications

    Three (3) copies of the application must be submitted: 1) an original, signed copy; 2) a single-sided copy on plain white paper for scanning (please label this copy); and 3) another photocopy for administrative purposes. Do not permanently bind or staple any of these copies; please use either binder or paper clips to secure them.

    Because of security concerns, paper applications cannot be personally delivered. They must be sent through regular mail, express mail, or a major courier.

    The following address must be used for regular mail:

    U.S. Environmental Protection Agency
    Peer Review Division (8725F)
    Funding Opportunity Number: (applicant: place the appropriate number here)
    1200 Pennsylvania Avenue, NW
    Washington, DC 20460

    The following address must be used for express mail and couriers:

    U.S. Environmental Protection Agency
    Peer Review Division (8725F)
    Funding Opportunity Number: (applicant: place the appropriate number here)
    1025 F Street, NW (Room 3500)
    Washington, DC 20004
    Phone: (202) 233-0686
  2. Submission Instructions for Electronic Applications

    Please read this entire section before attempting an electronic submission through Grants.gov.

    1. Preparing for Submission. The appropriate electronic application package available through the http://www.grants.gov site must be used for electronic submissions. Note: With the exception of the Budget form (available at http://www.epa.gov/ncer/rfa/forms), all necessary forms are included in the electronic application package. In order to view the application package, download the PureEdge viewer (click on "Apply for Grants", then see "Apply Step 1"). The application package may be quickly accessed from https://apply.grants.gov/forms_apps_idx.html using the appropriate FON. Be sure to download the electronic application package for the appropriate FON. Please register for announcement change notification emails.

      The electronic submission of your application package must be made by an official representative of your institution who is registered with Grants.gov and authorized to sign for Federal assistance. For more information, go to http://www.grants.gov and click on "Get Registered". Note that the registration process may take a week or longer to complete. If your organization is not currently registered with Grants.gov, please encourage your office to designate an Authorized Organization Representative (AOR) and begin the registration process as soon as possible. Most submission problems can be avoided by communicating with the AOR well before the solicitation closing date and allowing sufficient time for following the guidance provided below.

    2. Acknowledgement of Receipt. The complete application must be transferred to Grants.gov no later than 4:00 pm Eastern Time on the solicitation closing date (see "Submission Dates and Times"). Grants.gov provides acknowledgements of application receipt that include an on-screen notification of successful initial transfer as well as an e-mail notification of successful transfer from Grants.gov to EPA. While it is advisable to retain copies of these Grants.gov acknowledgements to document submission, the only official documentation that the application has been received by NCER is the e-mail acknowledgement sent by NCER to the Principal Investigator and the Administrative Contact. This email will be sent from receipt.application@epa.gov; email to this address will not be accepted. If an email acknowledgment from NCER (not support@grants.gov) has not been received within 30 days of the solicitation closing date, immediately inform the Eligibility Contact shown in this solicitation. Failure to do so may result in your application not being reviewed.
    3. Application Package Preparation. The application package consists of 1 though 4 below.
      1. On the initial electronic Grant Application Package page, complete the "Application Filing Name" field by entering the Principal Investigator's name, starting with the last name. Note: Applicants do not need to complete the "Competition ID" field.
      2. Application for Federal Assistance (SF 424): Complete the form.
      3. EPA Key Contacts Form 5700-54: Complete the form. If additional pages are needed, see (4) below.
      4. Project Narrative Attachment Form (click on "Add Mandatory Project Narrative"): Attach a single electronic file labeled "Application" that contains the items contained in Section IV.B.4. through IV.B.11.a of this solicitation. This file must be submitted in Adobe Acrobat PDF. Please review the PDF file for conversion errors prior to including it in the electronic application package; requests to rectify conversion errors will not be accepted if made after the solicitation closing date and time. If Key Contacts Continuation pages (see http://www.epa.gov/ncer/rfa/forms) are needed, place them before the Abstract (IV.B.4.).

      Once the application package has been completed, the "Submit" button should be enabled. If the "Submit" button is not active, please contact Grants.gov for assistance (Telephone: 1-800-518-4726). Investigators should save the completed application package with two different file names before providing it to the AOR to avoid having to re-create the package should submission problems be experienced.

    4. Transfer of Files. The application package must be transferred to Grants.gov by an AOR. The AOR should close all other software before attempting to submit the application package. Click the "submit" button of the application package. Your Internet browser will launch and a sign-in page will appear. Note: Minor problems are not uncommon with transfers to Grants.gov. It is essential to allow sufficient time to follow all trouble-shooting instructions before 4:00 pm Eastern Time on the solicitation closing date.

      A successful transfer will end with an on-screen acknowledgement. For documentation purposes, print this acknowledgement using "Print Screen." If you experience submission problems, reboot the computer - turning the power off may be necessary - and re-attempt the submission. If submission problems continue, contact Grants.gov for assistance (Telephone: 1-800-518-4726).

    5. Transmission Difficulties. If transmission difficulties that result in a late transmission, no transmission, or rejection of the transmitted application are experienced, follow the guidance below. NCER may decide to review the application if it is clearly demonstrated that these transmission difficulties were due solely as a result of problems associated with the transfer to Grants.gov. The decision regarding acceptance of the application for review will be made by NCER management and provided to the applicant within ten working days of the request. All e-mails, as described below, are to be sent to Thomas O'Farrell (o'farrell.thomas@epa.gov) with the FON in the subject line.
      1. Late transfer due to electronic submission problems: Should electronic submission problems result in the application being transferred to Grants.gov after 4:00 pm but before 5:00pm Eastern Time on the solicitation closing date, send an e-mail documenting the problem and include the Grants.gov "case number".
      2. Unsuccessful transfer of application package: If a successful transfer of the application cannot be accomplished due to electronic submission issues, send an e-mail before 5:00pm Eastern Time on the solicitation closing date. Document the problem, include the Grants.gov "case number," and attach the entire application.
      3. Grants.gov rejection of application: If a notification is received from Grants.gov stating that the application has been rejected for reasons other than late submittal, immediately send an email which includes any materials provided by Grants.gov with the entire application attached.

V. APPLICATION REVIEW INFORMATION

A. Peer Review
Applications will be evaluated in the following areas: (1) individual research projects, and (2) overall center plan including administrative structure and overall research integration plan.

All eligible grant applications are reviewed by an appropriate external technical peer review panel comprised of individual experts using the criteria below. This review is designed to evaluate each application according to its scientific merit. Each peer review panel includes non-EPA scientists, engineers, social scientists, and/or economists who are accomplished in their respective disciplines and proficient in the technical subjects they are reviewing. Reviewers are asked to individually assign a score of excellent, very good, good, fair, or poor to each application. EPA translates the average of these individual scores into the final panel review score.

Individual external peer review panel members consider an application's merit based on the criteria below. Criteria 1-5 are listed in descending order of importance:

  1. Research Proposal (criteria "1a" through "1f" are essentially equal):
    1. The originality and creativity of the proposed research, the appropriateness and adequacy of the proposed research methods, and the Quality Assurance Statement.
    2. Is the research approach practical and technically defensible, and can the project be performed within the proposed time period?
    3. Will the research contribute to scientific knowledge in the topic area?
    4. What are the projected benefits of the proposed activity to society, such as improving the environment or human health?
    5. Will the results be disseminated broadly to enhance scientific and technological understanding?
    6. Is the proposal well prepared with supportive information that is self-explanatory or understandable?
  2. Investigators: The qualifications of the Principal Investigator(s) and other key personnel, including research training, demonstrated knowledge of pertinent literature, experience, and publication records. Will all key personnel make a significant time commitment to the project?
  3. Responsiveness: The responsiveness of the proposal to the research needs identified for the research area. Does the proposal adequately address the objectives and special considerations specified by the RFA?
  4. Facilities and equipment: The availability and/or adequacy of the facilities and equipment proposed for the project. Are there any deficiencies that may interfere with the successful completion of the research?
  5. Budget: Although budget information does not reflect on the application's scientific merit, the reviewers are asked to provide their view on the appropriateness and/or adequacy of the proposed budget and its implications for the potential success of the proposed research. Input on requested equipment is of particular interest.

Applying the above listed criteria, reviewers will also evaluate the overall Center on the basis of its plan for integration of the research program around an overarching theme focusing on one or more of the research areas outlined in the RFA, the interdisciplinary nature of the proposed research activities, the capacity of the Center to achieve a stronger foundation in computational toxicology, and the ability of the projects to result in a greater contribution to the overall goals of the Center than if each were pursued independently.

In addition, using these criteria, reviewers will evaluate the scientific and organizational structure of the Center, the qualifications, responsibilities, and effectiveness of senior leaders, the duties and percent efforts of administrative staff of the Center in terms of their qualifications and contributions to the specialized needs and conduct of the Center's research activities, and the effectiveness of the Center's internal planning and quality management activities.

B. Programmatic Review
Applications receiving scores of excellent or very good as a result of the peer review process will then undergo an internal programmatic review, as described below, conducted by technical experts from the EPA, including individuals from the Office of Research and Development (ORD) and program and regional offices involved with the science or engineering proposed. All other applications are automatically declined.

After the peer review, those applicants who received scores of excellent or very good as a result of the peer review process will be asked to provide additional information for the programmatic review pertaining to the proposed Lead Principal Investigator's (PI) "Past Performance and Reporting History." The applicant must provide the EPA Project Officer with information on the proposed Lead PI's past performance and reporting history under prior Federal agency assistance agreements in terms of: (i) the level of success in performing each agreement, and (ii) how progress towards achieving the results intended under each agreement was reported. This information is required only for the proposed Lead PI's performance under Federal assistance agreements initiated within the last three years that were similar in size and scope to the proposed project.

The specific information required for each agreement is shown below, and must be provided within two weeks of EPA's request. A maximum of three pages will be permitted for the response; excess pages will not be reviewed. Note: If no prior past performance information and/or reporting history exists, you will be asked to so state.

  1. Name of Granting Agency.
  2. Grant/Cooperative agreement number.
  3. Grant/Cooperative agreement title.
  4. Brief description of the grant/cooperative agreement.
  5. A description of how the agreement is similar in size and scope to the proposed project and whether or not it was successfully performed; if not successfully performed, provide an explanation.
  6. Information relating to the proposed Lead PI's past performance in reporting on progress towards achieving the expected results (outputs/outcomes) under the agreement. Include the history of submitting timely progress/final technical reports, describe how progress towards achieving the expected results was reported/documented, and if such progress was not being made, provide an explanation of whether, and how, this was reported.
  7. Total (all years) grant/cooperative agreement dollar value.
  8. Project period.
  9. Technical contact (project officer), telephone number, and E-mail address (if available).

The purpose of the programmatic review is to assure an integrated research portfolio for the Agency and help determine which applications to recommend for award. In conducting the programmatic review, the EPA will consider information provided by the applicant and may consider information from other sources, including prior and current grantors and agency files.

The internal programmatic review panel will assess:

  1. The relevance of the proposed science to EPA research priorities.
  2. The proposed Lead PI's past performance (under Federal agency assistance agreements initiated within the last three years that were similar in size and scope to the proposed project) in two areas: First, in successfully performing these prior Federal assistance projects, including whether there is a satisfactory explanation for any lack of success. Second, in reporting progress towards achieving results under these agreements, including the proposed Lead PI's history of submitting timely progress/final technical reports that adequately describe the progress toward achieving the expected results (outputs/outcomes) under the agreements. Any explanation of why progress towards achieving the results was not made will also be considered. Applicants whose proposed Lead PI has no relevant past performance and/or reporting history, or for whom this information is not available, will be evaluated neither favorably nor unfavorably on these elements.
  3. The applicant's organizational experience.

C. Funding Decisions
Final funding decisions are made by the NCER Director based on the results of the peer review and internal programmatic review. In addition, in making the final funding decisions, the NCER Director may also consider program balance, available funds, and the Congressionally-mandated Experimental Program to Stimulate Competitive Research (EPSCOR) (see http://www.epa.gov/ncer/other/). Applicants selected for funding will be required to provide additional information listed below under "Award Notices." The application will then be forwarded to EPA's grants administration office for award in accordance with the EPA's procedures.

VI. AWARD ADMINISTRATION INFORMATION

A. Award Notices
Customarily, applicants are notified about evaluation decisions within six months of the application closing date. A summary statement of the scientific review by the peer panel will be provided to each applicant with an award or declination letter.

Applicants to be recommended for funding will be required to submit additional certifications and an electronic version of the revised project abstract. They may also be asked to provide responses to comments or suggestions offered by the peer reviewers, a revised budget, and/or to resubmit their proposal. EPA Project Officers will contact Principal Investigators to obtain these materials. Before or after an award, applicants may be required to provide additional quality assurance documentation.

Nonprofit applicants recommended for funding will be subject to a preaward administrative capability review consistent with sections 8.b, 8.c, and 9.d of EPA Order 5700.8, EPA Policy on Assessing Capabilities of Non-Profit Applicants for Managing Assistance Awards (http://www.epa.gov/ogd/grants/regulations.htm).

The official notification of an award will be made by the Agency’s Grants Administration Division. Applicants are cautioned that only a grants officer is authorized to bind the Government to the expenditure of funds; preliminary selection by the NCER Director in the Office of Research and Development does not guarantee an award will be made.

B. Disputes
Disputes related to this assistance agreement competition will be resolved in accordance with the dispute resolution procedures set forth in 70 FR 3629, 3630 (January 26, 2005) which can be found at http://www.epa.gov/ogd/competition/resolution.htm. Questions regarding disputes may be referred to the Eligibility Contact identified below.

C. Administrative and National Policy Requirements
Expectations and responsibilities of NCER grantees and cooperative agreement holders are summarized in this section, although the terms grant and grantee are used. See http://www.epa.gov/ncer/guidance for the full terms and conditions associated with an award, including which activities require prior approval from the EPA.

  1. Meetings: Centers must budget for, and participate in, annual grantees meetings (also known as progress reviews) that should be attended by the Center director and the appropriate project leads. Meetings will take place approximately once per year the U.S. EPA research facility in RTP, NC and will bring together all researchers currently supported through STAR computational toxicology efforts, as well as U.S. EPA scientists.
  2. Approval of Changes after Award: Prior written approval is required from the EPA if there will be a significant change from the work described in the application. Examples of these changes are contained in 40 C.F.R. 30.25. Note: prior written approval is also required from the EPA for incurring costs more than 90 calendar days prior to award.
  3. Human Subjects: A grant applicant must agree to meet all EPA requirements for studies using human subjects prior to implementing any work with these subjects. These requirements are given in 40 C.F.R. 26. For observational studies involving children or pregnant women or nursing mothers please refer to Subparts B & D of 40 C.F.R. 26. U.S. Department of Health and Human Services regulations at 45 CFR 46.101(e) have long required "... compliance with pertinent Federal laws or regulations which provide additional protection for human subjects." EPA's regulation 40 C.F.R Part 26 is such a pertinent Federal regulation. Therefore, the applicant's Institutional Review Board (IRB) approval must state that the applicant's study meets the EPA's regulations at 40 CFR 26. No work involving human subjects, including recruiting, may be initiated before the EPA has received a copy of the applicant's IRB approval of the project and the EPA has also provided approval. Where human subjects are involved in the research, the recipient must provide evidence of subsequent IRB reviews, including amendments or minor changes of protocol, as part of annual reports.
  4. Animal Welfare: A grant recipient must agree to comply with the Animal Welfare Act of 1966 (P.L. 89-544), as amended, 7 U.S.C. 2131-2156. The recipient must also agree to abide by the "U.S. Government Principles for the Utilization and Care of Vertebrate Animals used in Testing, Research, and Training" (50 Federal Register 20864-20865. May 20, 1985).
  5. Data Access and Information Release: After award, all data (including primary and secondary or existing data) must be made available to the NCER Project Officer without restriction and be accompanied by comprehensive metadata documentation adequate for specialists and non-specialists alike to be able to understand how and where the data were obtained and to evaluate the quality of the data. If requested, the data products and their metadata must be provided to the NCER Project Officer in a standard exchange format no later than the due date of the grant's final report or the publication of the data product's associated results, whichever comes first.

    Congress, through OMB, has instructed each federal agency to implement Information Quality Guidelines designed to "provide policy and procedural guidance...for ensuring and maximizing the quality, objectivity, utility, and integrity of information, including statistical information, disseminated by Federal agencies." The EPA's implementation may be found at http://epa.gov/quality/informationguidelines. These procedures may apply to data generated by grant recipients if those data are disseminated as described in the Guidelines.

    The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public 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. If such data are requested by the public, the EPA must ask for it, and the grantee must submit it, in accordance with A-110 and the EPA regulations at 40 C.F.R. 30.36.

  6. Reporting: A grant recipient must agree to provide annual progress reports, with associated summaries, and a final report with an executive summary. The summaries will be posted on NCER's website.

    A grant recipient must agree to provide copies of any peer reviewed journal article(s) resulting from the research during the project period. In addition, the recipient should notify the EPA Project Officer of any papers published after completion of the grant that were based on research supported by the grant. NCER posts references to all publications resulting from a grant on the NCER web site.

  7. Acknowledgement of EPA Support: EPA's full or partial support must be acknowledged in journal articles, oral or poster presentations, news releases, interviews with reporters and other communications. Any documents developed under this agreement that are intended for distribution to the public or inclusion in a scientific, technical, or other journal shall include the following statement:
    This publication [article] was developed under STAR Research Assistance Agreement No. __________ awarded by the U.S. Environmental Protection Agency. It has not been formally reviewed by the EPA. The views expressed in this document are solely those of [name of recipient] and the EPA does not endorse any products or commercial services mentioned in this publication.

A graphic that may be converted to a slide or used in other ways, such as on a poster, is located at http://www.epa.gov/ncer/guidance/star_images.html. EPA expects recipients to use this graphic in oral and poster presentations.

VII. AGENCY CONTACTS

Further information, if needed, may be obtained from the EPA officials indicated below. Information regarding this RFA obtained from sources other than these Agency Contacts may not be accurate. Email inquiries are preferred.

Eligibility Contact: Tom Barnwell (barnwell.thomas@epa.gov); phone: 202-343-9862
Electronic Submissions: Thomas O'Farrell (o'farrell.thomas@epa.gov); 703-347-8085
Technical Contacts:
Pasky Pascual (pascual.pasky@epa.gov); phone: 703-347-8056
Deborah Segal (segal.deborah@epa.gov); phone: 703-347-8528

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