Grantee Research Project Results
U. S. Environmental Protection Agency
Office of Research and Development
National Center for Environmental Research
Science to Achieve Results (STAR) Program
Closed - for reference purposes only
Computational Toxicology: Environmental Bioinformatics Research Center
This is the initial announcement of this funding opportunity.
Sorting Code Number: 2005-STAR-D1
Catalog of Federal Domestic Assistance (CFDA) Number: 66.509
Solicitation Opening Date: November 3, 2004
Solicitation Closing Date: February 24, 2005
Application receipt deadline date: February 24, 2005, 4:00 p.m. E.S.T.
Thomas Barnwell; Phone: 202-343-9862; email: email@example.com
The U.S. Environmental Protection Agency (EPA), through its Science to Achieve Results (STAR) program, is seeking applications for an Environmental Bioinformatics Research Center to develop and apply innovative computational methods to data from molecular biology and other studies to enhance the field of Computational Toxicology. The Agency has defined Computational Toxicology as the application of mathematical and computer models to better understand the mechanism(s) through which a given chemical or exposure induces harm and to predict adverse effects. The overall goals of the Agency’s Computational Toxicology Research Program are to use the modern tools of computational chemistry, molecular biology and systems biology to: improve the efficiency and effectiveness of the screening and testing programs used to assess potential toxicological hazard; reduce uncertainties in the evaluating the source-to-outcome continuum; and improve quantitative risk assessment. A key consideration is to help research evolve from current, largely empirical approaches, to approaches much more predictive in scope. Information on the Program can be found at http://www.epa.gov/comptox. The Center will be funded to support such efforts for up to five years through a cooperative agreement. The proposals should focus on the first and at least one other strategic objective of the computational toxicology program:
- Improve understanding of the linkages in the continuum between the source of a chemical in the environment and adverse health and ecological outcomes;
- Provide predictive models for screening and testing;
- Improve quantitative risk assessment.
This is the initial announcement for this year’s program. Although not anticipated, should modifications of this announcement be necessary, they will be posted.
Anticipated Type of Award: Cooperative Agreement
Estimated Number of Awards: One
Anticipated Funding Amount: Approximately $5.0 million.
Cost Sharing: None Required.
Potential Funding per Award: $1 million per year for a duration of up to five years and no more than a total of $5.0 million, including direct and indirect costs. Proposals with budgets exceeding the total award limits will not be considered.
Institutions of higher education and not-for-profit institutions located in the U.S., and Tribal, state, and local governments are eligible to apply. See full announcement for more details.
The necessary forms for submitting a STAR application will be found on the NCER web site, http://www.epa.gov/ncer/rfa/forms/. See Application and Submission Information section below.
Thomas Barnwell; Phone: 202-343-9862; email: firstname.lastname@example.org
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” (http://www.epa.gov/nheerl/humanhealth/HHRS_final_web.pdf) (PDF, 67pp., 1.50 MB, about PDF) and “Ecological Research Strategy” ( http://cfpub.epa.gov/si/osp_sciencedisplay.cfm?dirEntryID=17742&ref_site=SI&kwords=Ecological%20Research%20Strategy ) 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.
In 2002, ORD initiated a new research program in “Computational Toxicology” (http://www.epa.gov/comptox/comptox_framework.html) that uses emerging technologies to improve risk assessment and reduce uncertainties in this source-to-adverse outcome continuum. The first strategic objective of the Computational Toxicology Initiative is to 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. The second strategic objective is to 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. The third strategic objective is to apply computational toxicology to enhance quantitative risk assessment in the areas of dose-response assessment, cross-species extrapolation, and chemical mixtures. Meeting these objectives will require the development and application of innovative computational methods across a number of disciplines, which for the purposes of this solicitation are described as follows and include:
- Computational chemistry, which refers to development and application of theoretical methods, mathematical modeling, and computational simulation techniques for the study of molecular structures, interactions, and dynamics. This area includes the study of quantum mechanics, force fields, molecular mechanics, molecular simulation, molecular modeling, molecular design, and physical-chemical property prediction.
- Computational biology or bioinformatics, which refers to the development or application of theoretical methods, mathematical modeling and computational simulation techniques to the study of biological systems.
- Systems biology, which is a sub-discipline of computational biology concerned with the mathematical modeling and simulation of complex biological systems, attempting to explain and predict a system’s behavior in terms of an integrated view of the behaviors and interactions of the lower order components that make up that system.
Furthermore, for the purposes of this solicitation, bioinformatics is defined as the field of science in which biology, computer science, and information technology merge into a single discipline. There are three important sub-disciplines: 1) the development of new algorithms and statistics with which to assess relationships among members of large data sets describing different levels of biological organization and complexity, 2) the analysis and interpretation of various types of data including nucleotide and amino acid sequences, gene and protein expression, metabolite profiles, and protein domains and protein structures linked with more classical toxicological responses such as clinical chemistries, physiological changes and pathologies; and 3) the development and implementation of tools that enable the efficient access, management, and exchange of data from multiple sources.
This solicitation announces an extramural funding competition for the establishment of an Environmental Bioinformatics Research Center by means of a cooperative agreement. This solicitation provides relevant background information, summarizes EPA’s interest in supporting a Center and describes eligibility requirements and application instructions for the program.
EPA’s Computational Toxicology Research Program is a technology-based, hypothesis-driven effort to increase the soundness of risk assessment decisions. It is designed to increase the capacity to prioritize, screen, and evaluate chemicals by enhancing the predictive and overall understanding of toxicities. Success will be measured by the ability to improve risk assessments by understanding the potential of chemicals to affect molecular and biochemical pathways of concern.
In the area of computational biology, current research in genomics, proteomics, and metabonomics is being applied to study toxicological questions. On a parallel track, there have been major advances in computational technologies that enhance the ability to integrate and evaluate the vast amount of data being generated by the “-omics” and other technologies. The various technologies and tools necessary to reach the objectives of the computational toxicology program are at different levels of maturity. It is critical to support programs that will result in the development, application and convergence of the technologies to help meet the objectives of the overall program.
Research supported under EPA’s Computational Toxicology Initiative, as well as work being conducted by other institutions and organizations, is providing/will provide a wealth of information on: 1) environmental chemical transformation, 2) chemical metabolism, 3) cellular and molecular indicators of exposure, 4) dose metrics, 5) indicators of susceptibility, 6) linking exposure to effects of toxicants at multiple levels of biological organization by using genomic, proteomic, and metabonomic techniques, 7) foundation for QSAR and other computational approaches for prioritization of chemicals, 8) pollution prevention strategies, 9) high through-put screens, 10) dose-response relationships, 11) approaches to cross-species extrapolation, and 12) assessment of toxicity of chemical mixtures. In order to be most useful, this information must be analyzed, modeled, and integrated into a coherent picture. To maximally utilize this innovative data-intensive methodology and convert it into useful information, it will be critical to develop and apply innovative computational methods to integrate these biological and chemical data. With this solicitation, EPA is seeking to complement its strong intramural capacity that is developing biological and chemical data by establishing an Environmental Bioinformatics Research Center that would develop and apply novel computational approaches to data generated by EPA, and, to a lesser extent, by other institutions and organizations.
Sound computational methodologies are crucial to many stages of environmental research in order to integrate results in a meaningful way. Computational models and approaches have taken advantage of a wide array of mathematical tools, ranging from the development of complex matrices and network algorithms to advanced statistical correlations. The application of these mathematical tools in areas such as advanced gene ontology mapping, Monte Carlo methods, and the development of algorithms capable of mapping complex Bayesian belief networks, has given researchers the ability to mathematically model large volumes of array data and identify functionally related genes from the resulting expression profiles. Along with these advances in the application of mathematics to biological data sets has been the development of proper nomenclature and measurement units, which will increase the ability of datasets to be evaluated across platforms and the development of large virtual databases. These and other examples motivate modern computational methodologies research and illustrate the need for a cutting edge, cohesive national research capability in environmental computational methods.
This RFA includes a description (below) of the research needs, that the Environmental Bioinformatics Research Center applicants will address. These needs are broad, reflecting the crosscutting objectives of the Computational Toxicology Initiative. The EPA recognizes the difficulties in addressing all of the topics specified in the RFA and, therefore, that applicants will not be able to address all of the topics. However, the most critical needs in this program are multifaceted in nature.
The successful applicant will describe a scientifically sound multidisciplinary approach to the development and application of computational methods that target multiple points along the source-to-outcome continuum. In contrast with an individual grant or cooperative agreement award, the Environmental Bioinformatics Research Center presents the opportunity for investigators with differing expertise in computational approaches to work together on larger issues than could be addressed in a single grant or cooperative agreement proposal. Applicants should focus proposals on the computational area for which they have demonstrated expertise rather than extending beyond core strengths simply to address too many topics. Proposed Centers are encouraged to include arrangements that bring together institutions with strengths in different computational disciplines, provided that they can demonstrate how these collaborations will achieve more effective integrations in planning and implementing research. Centers should also discuss the application and development of bioinformatics standards and nomenclature, which will be utilized in order to increase the portability and usability of resources and tools produced by the Center.
The Center may be funded for up to five years; applications should clearly describe how the program might evolve during that time. A successful application will recognize that bioinformatics research priorities will evolve as new biological and chemical data are generated, new bioinformatics standards are developed, and as new computational methods and platforms are introduced. Applications need to include a detailed description of the process by which the Center will set priorities and phase in new activities, standards, and technologies, as appropriate. Research supported through the EPA’s Computational Toxicology Initiative should be constructed by considering the entire range of computational techniques that apply to environmental toxicology and biomedical issues highlighted in this RFA. Through the Center, all the relevant computational techniques will be embodied in components that are robust, efficient, easy to use, widely disseminated, interoperable, versatile, in conformity with best practices in software engineering, and well tuned to the most appropriate and powerful free-standing hardware and grid computing environments. Through such work, an iterative process might be used, for example, in which integration of new results into reducing the uncertainties along the source-to-outcome continuum may influence subsequent development and application of novel computational approaches.
Through this RFA, the Agency is soliciting proposals to develop an Environmental Bioinformatics Research Center that will develop and apply novel computational methods to data generated through EPA’s intramural research program, and to a lesser extent, from other institutions and organizations. EPA scientists are developing the biological and chemical data from these investigational areas and can serve as research collaborators, sources of problem issues, data, and experience with key issues important in the Computational Toxicology research program. The Center is expected to interact with EPA researchers. However, EPA researchers must be alert for any conflicts of interest associated with the solicitation, review, or decision-making processes related to the application.
Successful applications must address multiple components of the first investigational area and at least one of the other two areas. In doing so, they must also highlight the direct relationship between the mathematical research and the biological applications.
Investigational Area 1 – Improve Linkages in the Source-to-Outcome Paradigm (Note: The main bullets under each of the three investigational areas are consistent with the research areas identified in EPA’s “Computational Toxicology Framework.” The sub-bullets give examples of areas for which EPA scientists and grantees are/will be developing data that can be used by the applicants to this solicitation).
- Environmental chemical transformation
- Models to predict transformation pathways, products and reaction kinetics
- Chemical metabolism
- Metabolism of xenobiotic chemicals as a predictor of toxicity
- Molecular and cellular indicators of exposure
- Gene expression changes in blood and respiratory tissues produced by short-term exposures of laboratory animal models, sentinel species, or humans to environmental agents
- Dose metrics
- Dosimetry models of particulate matter and air toxics
- Characterization of toxicity pathways
- Estrogen, androgen, and thyroid signaling pathways and xenobiotics metabolizing enzyme pathways during development, reproduction, and carcinogenesis
- Identifying the relationship between diesel exhaust particles’ composition and their genotoxic and inflammogenic effects
- NMR-based analysis of metabolic changes in biological fluids and tissues from exposed laboratory rodents and small fish models
- Systems biology
- Identifying chemicals with the potential to disrupt endocrine function through alterations in the hypothalamic-pituitary gonadal and hypothalamic-pituitary-thyroid axes
- Modeling frameworks and uncertainty analysis
- Physiologically-based pharmacokinetic (PBPK) models to evaluate how variations in dose route and delivery rate affect different internal dose metrics
- Predicting toxicity of chemicals before standard signs of toxicity are observable
Investigational area 2 – Predictive Models for Hazard Identification
- Quantitative Structure Activity Relationships (QSAR) and other computational approaches
- Development of databases and QSAR models incorporating historical pharmacology and toxicology data sets for categorizing and prioritizing lists of chemicals for toxicological evaluation/testing
- Pollution prevention strategies
- Microbial Source Tracking (MST) methods of monitoring fecal pollution
- High through-put screens
- Reporter gene assays for chemicals that activate the nuclear receptor pathways as well as inducers of xenobiotic metabolizing enzymes
- Bioluminescence reporter systems (BLYES) in environmental monitoring and risk assessment
- In silico molecular docking models for describing the relative affinity of chemicals to interact with macro molecular targets
- Zebrafish (Danio rerio), medaka fish (Oryzias latipes), and Daphnia magna models for real-time quantitative RT-PCR and cDNA microarray analysis of gene response to endocrine disrupting chemicals
Investigational area 3 – Enhanced Quantitative Risk Assessment
- Dose-response assessment
- Linkage of genomic, proteomic or metabonomic data to the induction of classical indicators of adverse health effects in laboratory animal models
- Utilization of genomic, proteomic and metabonomic information in conjunction with data from higher levels of biological organization in order to understand dose-response patterns at levels below those inducing detectable frank adverse effects in standard laboratory models
- Cross-species extrapolation
- Compare gene expression changes in rodent blood and respiratory tissues with gene expression changes in asthmatic children residing in areas of varying degrees of air pollution
- Homology of toxicity pathway induction between alternative animal species such as C. elegans and zebrafish versus traditional laboratory animals such as rodents and the fathead minnow, and ultimately to human toxicity pathways
- Chemical mixtures
- Theoretical understanding of potential molecular level interactions of chemicals in the modification of toxicity pathways by use of advanced chemical and biological tools
Although the specific directions of EPA’s Computational Toxicology Research Program are still emerging, general areas of interest that represent the types of research that will be supported by the program include:
- Monitoring of exposure to mixtures of stressors using molecular diagnostic indicators of possible adverse human health effects.
- Predicting the outcome of metabolism of xenobiotics at different levels of biological organization, and the pathogenicity of microorganisms
- Developing and applying statistical methodology and computational chemistry tools
- Developing molecular docking models of key toxicity receptors such as the steroid hormone receptors or other transcriptional regulatory proteins
- Understanding and modeling chemical source/stressor formation, transport and transformation, environmental characterization, exposure, dose, early biological effects, altered structure/function, disease
- Modeling of biologically relevant biotransformation processes in the environment and physiologically based pharmacokinetic processes within organisms
- Generating molecular signatures predictive of outcomes for toxicant classes, linking these profiles to biological and pathophysiological processes, and identifying and facilitating the structural characterization of exposure-specific genes
- Integration and interpretation of genomic, proteomic, and metabonomic data
Sources of the numerical, graphic, and text-based data sets that will be made available will include:
- Gene expression data from gene microarray analysis (Affymetrix, Agilent, and custom arrays), Real-Time PCR data, clonal libraries, flow cytometry, rtPCR (mRNA data), and Quantitative PCR
- Protein expression data from protein microarrays, Ciphergen ProteinChips, 2-Dimensional gel electrophoresis (2D SDS-PAGE), immunoassays, mass spectrometry, and Western blotting
- Organism sources will include: bacteria, C. elegans, zebrafish, fathead minnow, medaka, Xenopus laevis, Xenopus tropicalis, rat, and mouse models, and humans
- Data will be generated using physical and biological data collected from various sources, which may include: tissue culture, primary tissue, surrogate tissues, biological fluids, bacteria culture, chemical libraries and environmental surveys
- Databases, models, analysis tools, and other data generated will include: multi-species microbial metagenomic libraries, bacterial 16S rDNA clone libraries, toxicogenomic libraries, metabolism profiles via High-Resolution NMR, dose metrics for multiple exposure routes, PBPK/PD models, DSSTox data files, ToxicoGenomic Tracking Database with integrated transcriptomic, proteomic, and metabonomic data
EPA’s Computational Toxicology Research Program website is updated periodically with more detailed descriptions of the research program and should be monitored frequently (http://www.epa.gov/comptox).
Each application should address the following:
- Center Description - 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 (5 pages).
- Bioinformatic Capabilities - Applications should describe the computational and network resources available as well as the specific types of statistical and bioinformatic approaches that exist within their organizations and how such capabilities can be applied to the selected Investigative Areas. Applications should 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. Each of the Investigative Areas should be completely described according to the Supplemental Instructions section of this RFA. Each Area is permitted a 15-page description. Individual project descriptions must explain how the project fits into the overall Center program and relates to other projects in the proposal.
- Administrative Core Unit (15 pages) - Each Center should have an Administrative Core Unit, which provides overall oversight, coordination and integration of the Center’s activities. As part of the Administrative Core description, applications should provide a Center Integration Plan describing how the program will be integrated internally. Center proposals should take a multidisciplinary approach. The Center’s Integration Plan, at a minimum, should indicate how programmatic and funding decisions will be made; how new projects will be solicited, reviewed and selected; how investigators from different computational disciplines within the Center will communicate on a regular basis about the development and progress of Center projects; how investigators will interact and communicate with EPA researchers; 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.
The Center proposal should also address how the Center will disseminate research results and other information. 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.
Additional responsibilities of the Administrative Core include (as described below under “After Cooperative Agreement Award”): organization of Scientific Advisory Committee (SAC) meetings, and development of responses to SAC recommendations.
- In conducting its research, the Center must demonstrate a willingness to use data generated by EPA and other institutions or organizations, as the bases for their development and application of computational methods. 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 by the use of existing databases or data available through collaborators such as EPA NIEHS, or the CDC. The Center is also encouraged to consider the potential to periodically co-locate Center staff for short periods of time in EPA research facilities for the purpose of enhancing the quality of the collaborations and interactions.
- Training - The Center must include a Public Outreach and Translation Activity (POTA), the purpose of which is to develop, implement and evaluate strategies to translate and apply the scientific findings of the Center into information for the public, policy makers, and professionals to use in improving the ability to screen and prioritize environmental agents relative to evaluation of adverse health effects. Examples of activities that could be conducted would be the creation of training materials for risk assessors and toxicologists, development of a database for storage and analysis of toxicogenomic data, enhancing development of public toxicogenomic databases, novel strategies for dissemination of research findings to the broad audience of stakeholders, and focus groups to assess public understanding of various technologies and data interpretation procedures. (It is anticipated that a Center will devote between 5 and 10 percent of its budget to the POTA).
- New Investigators – To attract new investigators into bioinformatics research, 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. The duration of support as a newly recruited scientist is limited to two years. Given a duration of five years for the Center, then a total of two new investigators should be supported, one at a time. Following termination of support as a newly recruited Center scientist, such an individual may, if appropriate, become or continue to be a part of the Center. Recruitment of women and underrepresented minority scientists is specifically 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.
The authority for this RFA and resulting awards is contained in the Clean Air Act, Section 103, as amended, Public Law 95-95, 42 U.S.C. 7401 et seq., the Clean Water Act, Section 104, as amended, Public Law 95-217, 33 U.S.C. 1251 et seq., the Toxic Substances Control Act, Section 10, the Federal Insecticide, Fungicide, and Rodenticide Act, Section 20, and the Comprehensive Environmental Resource Conservation and Liability Act, Section 311(c).
It is anticipated that a total of approximately $5 million will be awarded, depending on the availability of funds. One award in the form of a cooperative agreement will be made under this RFA. The projected award per cooperative agreement is $1 million per year total costs, for up to 5 years. Continued funding will be determined by the results of a formal review of progress during project year 3. The total project period for an application submitted in response to this RFA may not exceed 5 years. Requests for amounts in excess of a total of $5 million, including direct and indirect costs, will not be considered.
Institutions of higher education and not-for-profit institutions located in the U.S., and Tribal, state, and local governments are eligible to apply. Universities and educational institutions must be subject to OMB Circular A-21. Profit-making firms are not eligible to receive cooperative agreements from 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 engage in lobbying activities as defined in Section 3 of the Lobbying Disclosure Act of 1995 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 principal investigator, but may not direct projects on behalf of the applicant organization or principal investigator. The principal investigator's institution, organization, or governance may provide funds through its cooperative agreement from EPA to a 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 a cooperative agreement, and may not receive salaries or in other ways augment their agency's appropriations through awards made by this program. Nonetheless, federal employees may interact with awardees in the form of “cooperation.” Cooperation involves the sharing or comparing of samples, equipment, facilities, data, and/or models during the conduct of the research in which the interaction is substantial and requires the award of a cooperative agreement rather than a grant. Substantial involvement occurs when the collaboration or cooperation of the EPA researcher is necessary to achieving the overall goals of the research supported by a cooperative agreement.
The principal investigator’s 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, along with an assurance from the federal agency involved which commits it to supply the specified service.
Potential applicants who are uncertain of their eligibility should contact Tom Barnwell in NCER, phone 202-343-9862, email: email@example.com
Institutional cost sharing is not required and, therefore, does not have to be included in the budget table. However, if the applicant intends to cost-share, 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.APPLICATION AND SUBMISSION INFORMATION
Application forms and instructions for applying can be found on the NCER web site at:
The initial application is made through submission of the materials described below. It is essential that the application contain all information requested and be submitted in the formats described. Noncompliance with formatting instructions (page limits, font size, etc.) is grounds for administrative dismissal. Please note that if an application is being considered for an award (i.e., after external peer review and internal review), additional forms and other information will be requested by the EPA Project Officer. The application must contain the following:
A. Standard Form 424: The applicant must complete SF424. This form will be the first page of the application. Instructions for completion of the SF424 are included with the form. The form must contain the original signature of an authorized representative of the applying institution. Please note that both the Principal Investigator and an administrative contact are to be identified in Section 5 of the SF424.
Regarding Block 16 of the SF 424: research funded under this program may be eligible under E.O. 12372, “Intergovernmental Review of Federal Programs,” if it affects public health or if an environmental impact statement is required. If applicable, an applicant should consult the office or official designated as the single point of contact in his or her State for more information on the process the State requires to be followed in applying for assistance, if the State has selected the program for review.
B. Key Contacts: The applicant must complete the Key Contacts Form (NCER Form 1) as the second page of the application. The Key Contacts Form and a continuation page are available at http://www.epa.gov/ncer/rfa/forms. A copy of this form should also be completed for major sub-agreements (contacts at the institutions of primary co-investigators). Please make certain that all contact information is accurate. An email will be sent by NCER (from firstname.lastname@example.org; emails to this address are not accepted) to the Principal Investigator (with a copy to the Administrative Contact) to acknowledge receipt of the application and to transmit other important information. If an email acknowledgment has not been received within 30 days of the submission deadline, then immediately contact the project officer listed under "Contacts" in this solicitation. Please note: Due to often-lengthy delays in delivery, it is especially important that you monitor NCER confirmation of receipt of your application when using regular mail.
C. Table of Contents: Provide a list of the major subdivisions of the application indicating the page number on which each section begins.
D. Abstract: The abstract is a very important document. All abstracts are provided to the peer review panelists, and some of the panelists may read only the abstract. Abstracts also play a critical role in programmatic review (see “Application Review Information”). Therefore, it is critical that the abstract accurately describe the research being proposed and conveys all the essential elements of the research and Center. Also, the abstracts of applications that receive funding will be posted on the NCER web site.
The abstract, limited to two pages, should include the information indicated in the example format (http://www.epa.gov/ncer/rfa/forms) and described below (1-8). Examples of abstracts for current grants may be found on the NCER web site.
- Research Category and Sorting Code: Enter the full name of the solicitation under which your application is submitted and the code that corresponds to the appropriate RFA topic.
- 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 phrases such as “research on.”
- 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.
- Institution: In the same order as the list of investigators, list the name and city/state of each participating university or other applicant institution. The institution applying for assistance must be clearly identified.
- Project Period: Show the proposed project beginning and ending dates.
- Project Cost: Show the total dollar request, including direct and indirect costs, to the EPA for all cooperative agreement years (the entire project period).
- Project Summary: Provide three subsections addressing: (a) the objectives of the study (including any hypotheses that will be tested), (b) the approach to be used (a description of the project proposed), and (c) 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.
- Supplemental Keywords: Supply keywords to assist database searchers in finding your research, without duplicating terms already used in the text of the abstract. A complete set of keywords is very important. A list of suggested keywords will be found at http://www.epa.gov/ncer/rfa/forms.
E. Research Plan, Supplemental Instructions and Quality Management Plan
Applications should be focused on a limited number of research objectives that can be adequately and clearly demonstrated to meet the RFA requirements. Explicitly state the main research issues relevant to the Computational Toxicology Program that you will investigate, the types of data you will, or would like to, use, the bioinformatic/analytical tools you will develop and/or apply to investigate these research issues or analyze these data, and the results you expect to achieve. Research approaches must be clearly stated so that the reviewers can evaluate the appropriateness of your approach and the tools you intend to develop and/or apply. For example, the statement: “we will evaluate the data using the usual statistical methods” is not specific enough for peer reviewers.
The Research Plan should include a description (not to exceed five pages) for the overall Center objectives approach, and expected benefits and a description for each research project proposed (not to exceed fifteen pages per project). The descriptions must be consecutively numbered (bottom center), 8.5x11-inch pages of single-spaced, standard 12-point type with 1-inch margins. The project descriptions must provide the following information:
- Objectives: List the objectives of the proposed research during the project, and briefly state why the intended research is important. This section should also include any background or introductory information that would help explain the objectives of the study. If this application is for continuation of research supported by an existing or former grant awarded under the STAR program, indicate the number of the grant and provide a brief report of progress and results achieved under that grant (one to two pages recommended).
- Approach: Outline the bioinformatic approach, methods, and techniques that you intend to develop and/or apply in meeting the objectives stated above (five to ten pages recommended).
- Expected Results or Benefits: Describe the results you expect to achieve during the project and the benefits of the results. This section should also discuss how the bioinformatic approaches to the various issues 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 understand the merits of the research (one to two pages recommended).
- General Project Information: Discuss other information relevant to the potential success of the project. This should include facilities, personnel, project schedules, proposed management, interactions with other institutions, etc. Applications for multi-investigator projects must identify project management and the functions of each investigator within a team and describe plans for communication and sharing of data (one to two pages recommended).
- Important Attachments:
References cited are in addition to the aforementioned page limits.
Letters of intention that are limited to one brief paragraph merely ensuring commitment of a resource (e.g., use of a person’s time or equipment) not under the control of the applicant institution may be included and are in addition to the aforementioned page limits.
Letters of intention that exceed one brief paragraph will be considered a part of the appendix.
Appendices may be included but must remain within the aforementioned page limits.
After Cooperative Agreement Award
These instructions supplement the section in the Standard Instructions entitled “Expectations and Responsibilities of STAR Grantees.” This research will be funded through a cooperative agreement in order to facilitate collaboration between the award recipient, the bioinformatics community, and EPA. The long-term application of computational tools to integrate biological and chemical data necessitates close linkages across the research to ensure the multiple components are complementary and compatible. Therefore, after award, the recipient should anticipate establishing collaborative relationships with EPA Laboratories/Centers through an initial meeting. For budgeting purposes assume this meeting will be in Research Triangle Park, NC.
After EPA officials develop the recommendation for the award, the applicant will be notified and the EPA Project Officer will begin negotiations with the recommended applicant to develop final cooperative agreement(s) that will form the legal basis for the award of assistance funding. EPA anticipates that these negotiations will occur during July 2005 and that one mandatory meeting in Research Triangle Park will be necessary to successfully complete these negotiations. Issues to be included in the negotiation at this juncture include: formal identification of key personnel, modification to the applicant’s plan that respond to the written peer panel evaluations regarding weaknesses that can be improved, negotiations about the nature of the collaboration by the principal investigator(s) with EPA scientists, engineers, and incorporation of this collaboration into the final cooperative agreement plan, and final budgets and terms of the agreement. The purpose of this final negotiation step is to ensure that all planning, application, and award paperwork – as well as implementation procedures – have been documented properly and are clearly understood by the affected parties. After the cooperative agreement is awarded the Center will work with the EPA Project Officer and Director of the Computational Toxicology Initiative to address the following:
- Integration Between the Center and EPA: Experience from other EPA Centers and recommendations from the Agency’s Science Advisory Board regarding Centers, underscores the notion that integration of activities enhances their scientific and technological understanding and productivity. Integration with ongoing EPA research in Computational Toxicology will require significant commitment, time and effort.
- Communications – The Center is expected to develop and maintain Center websites, communicate key results at annual scientific conferences, and participate in annual EPA investigator meetings. A portion of the website should be specifically devoted to educating the public on how bioinformatic approaches to data mining and interpretation can be applied to environmental issues. The Center will produce annual progress reports and a final report at the end of the cooperative agreement period.
- Administrative Contact – The Center will identify an individual to be the main point of administrative contact with the EPA Project Officer and Director of the ORD Computational Toxicology Initiative. This person will be responsible for ensuring that information on Center publications, press releases, progress reports, quality assurance, science advisory committees, and other documentations is provided to the Project Officer and Initiative Director in a timely fashion.
- Science Advisory Committees: After award, the Center must establish an external science advisory committee (SAC) that can provide objective, independent, technical advice to the Center to ensure scientific quality and progress. The SAC membership typically consists of 6-10 peer reviewers selected from the academic, private, and public sectors, and an EPA representative(s). The function of the SAC is to assist in evaluating the (1) merit, value and contribution of existing and future research projects, and (2) relevance and importance of the individual research elements to accomplishing the overall goals of the Center. Within 90 days of the award, the Principal Investigator must submit a list of nominees for the SAC to the Project Officer and Director of the Computational Toxicology Initiative for approval by EPA. Potential SAC members must NOT be contacted, identified, or queried prior to receipt of the award.
Within three months of the award, the Environmental Bioinformatics Research Center will form an Environmental Bioinformatics Research Center Committee that will consult monthly with EPA to exchange ideas, research, protocols, and other information. The group will identify areas that would benefit from harmonization, such as joint workshops, and sharing of data, expertise or technologies. EPA anticipates that the Environmental Bioinformatics Research Center Committee will discuss and act on some areas of shared interest, and that subcommittees will be formed as needed to address more specialized topics. EPA scientists will help organize and participate in joint working groups, as appropriate. This level of interaction is critical to a successful outcome for the Environmental Bioinformatics Research Center, and creative plans to ensure this type of interaction and success are encouraged.
The Environmental Bioinformatics Research Center will hold a meeting with its SAC annually. Upon receiving the written recommendations from the SAC, the Center Director shall submit a formal letter to EPA and the SAC chair with its response to the SAC comments and a plan for how the Center will address the comments and implement any suggested improvements.
Quality Management Plan (five pages in addition to Research Plan)
For any project involving data collection or processing, conducting surveys, environmental measurements, modeling, or the development of environmental technology (whether hardware-based or via new techniques) for pollution control, the EPA requires a plan discussing processes that will be used to ensure that results of the research satisfy the intended project objectives. The required plan is described below. This requirement for a brief Quality Management Plan (QMP) replaces the requirement “2.J. Quality Assurance Statement” in the Standard Instructions.
EPA is particularly interested in the quality controls for data generation and acquisition, and how data validation and usability will be verified. The QMP must describe a system that complies with ANSI/ASQC E4, Specifications and Guidelines for Quality Systems for Environmental Data Collection and Environmental Technology Programs, and must not exceed five consecutively numbered, 8.5x11-inch pages of single-spaced, standard 12-point type with 1-inch margins. ANSI/ASQC E4 is available for purchase from the American Society for Quality, phone 1-800-248-1946, item T55. Only in exceptional circumstances should it be necessary to consult this document.
The QMP provided with the application must contain the information below. EPA’s Quality System will likely require an expanded version of this document following award.
1. Summary - A discussion of the overall quality assurance and quality control needs of the Center and the objectives of the Center’s Quality Assurance and Quality Control (QA/QC) policy.
2. Organization and Management - This section should include:
A) Organization chart that identifies:
– all of the components (research project or core activity) of the Center;
– the Principal Investigator or overall manager for each component;
– the person responsible for QA/QC activities for each component and how they report to the QA Manager and Center Director;
B) Description of the specific responsibilities of the QA Manager and any other personnel with QA responsibilities;
C) Description of any delegations of QA responsibility to sub-awardees or contractors (especially QC responsibilities); and
D) Discussion of how the Center will maintain effective communications throughout the management structure.
3. Quality System - This section should include brief discussions of:
A) How the Center’s research activities will be reviewed and evaluated to ensure quality;
B) How staff will be trained, and who is responsible for training;
C) How data will be stored and made available to Center personnel and to the public; and
D) How the Center’s QA/QC procedures will be reviewed and evaluated, including how recommended changes will be implemented.
4. Project or Component Specific - This section should discuss the QA and QC needs for the Center’s components and should describe or reference any standard procedures (such as SOPs) that will be used to address these needs. (Individual project QA plans, expected after award as part of the Center’s QA program, should include descriptions of how the data needs relate to the hypotheses being tested or the objectives.) This section should also address the following:
A) How the sample size(s) will be selected and demonstrated to be sufficient to test the hypotheses or meet a specific objective;
B) How the necessary performance criteria for measured data to test the hypotheses or meet the objective will be identified;
C) How the quality of previously collected data will be determined appropriate for its stated use;
D) How data will be managed (collected, backed-up, collated, transferred, and stored) to ensure that the quality is maintained and documented; and
E) What data analysis methods will be used.
5. Documentation and Records - Describe or reference the procedures the Center will use for identifying and maintaining QA and QC related documents and records.
ANSI/ASQC E4, Specifications and Guidelines for Quality Systems for Environmental Data Collection and Environmental Technology Programs, is available for purchase from the American Society for Quality, phone 1-800-248-1946, item T55. Only in exceptional circumstances should it be necessary to consult this document. An EPA guidance document, Guidance on Satisfying EPA Quality System Requirements for STAR Grants (EPA QA/G-1STAR) is available for potential applicants and addresses in detail how to comply with ANSI/ASQC E4 for STAR grants. This may be found on the Internet at http://www.epa.gov/ncer under “Guidance and FAQs.”
Congress, through OMB, has instructed each 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.” EPA’s implementation may be found at http://www.epa.gov/quality/informationguidelines/. These procedures may apply to data generated by cooperative agreement recipients if those data are disseminated as described in the Guidelines.
Page allowances for the following sections are in addition to those allowed for the Research Plan and Quality Management Plan.
F. Budget and Budget Justification
Prepare a budget table using the guidance and format found at http://www.epa.gov/ncer/rfa/forms/, select “All required forms.” If a sub-agreement, such as a subcontract, is included in the application, provide a separate budget for the subcontract in the same format. Include the total amount for the sub-agreement under “Contracts” in the master budget. Any project containing sub-agreements that constitute more than 40% of the total direct cost of the grant will be subject to special review. Additional justification for use of such a subcontract must be provided, discussing the need for this agreement to accomplish the objectives of the research project.
The page limits identified in the table below should not be exceeded.
Please note that institutional cost-sharing is not required. However, if you intend to cost-share, 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.
Describe the basis for calculating the personnel, fringe benefits, travel, equipment, supplies, contractual support, and other costs identified in the itemized budget and explain the basis for their calculation. (Special attention should be given to explaining the “travel,” “equipment,” and “other” categories.) The budget justification should not exceed the limits identified in the table above and should be 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.
- Personnel: List all staff positions by title. Give annual salary, percentage of time assigned to the project, and total cost for the budget period.
- Fringe Benefits: Identify the percentage used and the basis for its computation.
- Travel: Specify the estimated number of trips and locations, and other costs for each type of travel. Explain the need for any travel outside the United States. Include travel funds for annual STAR program progress reviews and a final workshop to report on results.
- Equipment and Specialized Software: Identify computers, specialized software, and each item to be purchased which has an estimated cost of $5,000 or more per unit and a useful life of more than one year. (Items with a unit cost of less than $5,000 are considered supplies, per regulation.)
- Supplies: “Supplies” means all tangible property other than “equipment.” Identify categories of supplies to be procured (e.g., software under $5,000, office supplies).
- Contractual: Identify each proposed sub-agreement (grant or contract) and specify its purpose and estimated cost. Sub-agreements more than $25K should have a separate itemized budget included as part of the application.
- Other: List each item in sufficient detail for the EPA to determine the reasonableness of its cost relative to the research to be undertaken.
- Indirect Charges: If indirect charges are included in the budget, indicate the approved rate and base with an explanation of how indirect costs were calculated.
G. Resumes and Current and Pending Support
Provide the resumes of all principal investigators and important co-workers. 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.
Current and Pending Support
Identify any current and pending financial resources that are intended to support research related to the proposal or which would consume the time of principal investigators. Provide information on current and pending support in the format provided at http://www.epa.gov/ncer/rfa/forms for each investigator and other important co-workers.
The following page limitations supercede those in the Standard Instructions:
The following page limitations may not be exceeded:
|Abstracts||2 page abstract for the Center as a whole|
|Research Plan||5 pages for overall Center objectives, approach, and expected
15 pages for each research project description
|Administrative Core||15 pages|
|Budget||Budget summary pages and project pages should include
both annual budgets for each year, one through five, and
cumulative totals for the entire five year period:
2 page summary for total Center budget
2 pages per project
2 pages for Administrative Core
|Budget Justification||2 pages per project
2 pages for Administrative Core
|Quality Management||5 pages|
H. Guidelines, Limitations, and Additional Requirements
By submitting an application in response to this solicitation, the applicant grants 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.
At various places within the application, applicants are asked to identify the sorting code corresponding to their proposed research topic area in the solicitation. The sorting code must be placed at the top of the abstract (location is shown in the abstract format, http://www.epa.gov/ncer/rfa/forms), in Box 10 of Standard Form 424, and in the address on the package that is sent to the EPA (see below).
The original and eight (8) copies of the complete application (9 in all) and one (1) additional copy of the abstract, must be received by NCER no later than 4:00 P.M. Eastern Time on the closing date assigned to this topic area. The following is the schedule for this RFA. It should be noted that this schedule may be changed without prior notification due to factors that were not anticipated at the time of announcement. In the case of a change in the required receipt date, the new date will be posted on the NCER website.
Application Receipt Date: February 24, 2005, 4:00 p.m. E.S.T.
Earliest Anticipated Start Date: August 2005
To be considered timely, applications and initial proposals must be received by the Agency on or before the deadline date published in the RFA. Applications received after the published deadline or applications that deviate from the prescribed format will be returned to the sender without further consideration. Also, applications exceeding the funding limits described in the RFA will be returned without review.
Research funded under this program may be eligible under E.O. 12372, “Intergovernmental Review of Federal Programs,” if it affects public health or if an environmental impact statement is required. If applicable, an applicant should consult the office or official designated as the single point of contact in his or her State for more information on the process the State requires to be followed in applying for assistance, if the State has selected the program for review. The names and addresses of the State’s single point of contact are listed in the OMB home page at
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 Public Law 95-224, the primary purpose of a cooperative 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 cooperative agreement, the EPA anticipates that there will be the sharing or comparing of samples, equipment, facilities, data, and/or models during the conduct of the research in which the interaction is substantial. Substantial involvement occurs when the collaboration or cooperation of the EPA researcher is necessary to achieving the overall goals of the research supported by a cooperative agreement. In addition, EPA will monitor research progress through annual reports provided by awardees and other contacts, including monthly consultations with the Environmental Bioinformatics Research Center Committee, annual meetings with the SAC, and site visits with the Principal Investigator.
If you wish to submit applications for more than one STAR RFA, you must ensure that the research proposed in each is significantly different from any other that has been submitted to the EPA or from any other grant you are currently receiving from the EPA or another federal government agency.
Collaborative applications involving more than one institution must be submitted as a single administrative package from one of the institutions involved.
The application and abstract must be prepared in accordance with these instructions. Informal, incomplete, or unsigned applications will be returned without review. The original, signed copy of the application must not be bound or stapled in any way. The other eight (8) required copies of the application should be secured with paper or binder clips or secure staples.
Because of security concerns, 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)
Sorting Code: 200X-STAR-XX (replace the "XX" with the appropriate code)
1200 Pennsylvania Avenue, NW
Washington, D.C. 20460
The following address must be used for express mail and couriers:
U.S. Environmental Protection Agency
Peer Review Division (8725F)
Sorting Code: 200X-STAR-XX (replace the "XX" with the appropriate code)
1025 F Street, NW (Room 3500)
Washington, DC 20004
Phone: (202) 233-0686
Applications will be evaluated in the following areas: (1) the individual research projects and (2) the overall Center plan, including administrative structure and overall research integration plan.
Consideration of an application’s merit is based on the following criteria: All else being equal, proposals that consider multiple environmental benefits will be ranked higher than those that consider only single benefits, and proposals that involve an interdisciplinary team of researchers will be ranked higher than those that include only a single discipline.
- The originality and creativity of the proposed research, the appropriateness and adequacy of the research methods proposed, and of the Quality Management Plan. Is the research approach practical and technically defensible, and can the project be performed within the proposed time period? Will the research contribute to scientific knowledge in the topic area? Will the results be disseminated broadly to enhance scientific and technological understanding? What may be the benefits of the proposed activity to society? Is the proposal well prepared with supportive information that is self-explanatory or understandable?
- 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?
- The responsiveness of the proposal to the research needs identified for the topic area. Does the proposal adequately address the objectives specified by the EPA for this topic area?
- 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?
- 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.
All cooperative agreement applications are reviewed by an appropriate external technical peer review panel. In general, each peer review group is composed of non-EPA scientists, engineers, social scientists, and/or economists who are experts in their respective disciplines and are proficient in the technical subjects they are reviewing. Reviewers are asked to assign a summary score of excellent, very good, good, fair, or poor to each application. This review is designed to evaluate each proposal according to its scientific merit.
Applications that receive scores of excellent and very good from the peer reviewers are subjected to a programmatic review within the EPA to ensure a balanced research portfolio for the Agency. The programmatic review considers the relevance of the proposed science to EPA research priorities, program balance, budget, and available funds. Final funding decisions are made by the NCER Director. Selected applicants will be required to provide additional information and the application will be forwarded to the grants administration office for award in accordance with the EPA’s procedures.
The following is the schedule for this RFA. Please note that this schedule may be changed without notification due to factors that were not anticipated at the time of announcement.
Application Receipt Date: February 24, 2005
Earliest Anticipated Start Date: August 2005
Customarily, applicants are notified about award decisions approximately six months after the application deadline. A summary statement of the scientific review by the peer panel will be provided to each applicant with the award or declination letter. After selection for award, applicants recommended for funding will be required to submit additional certifications and an electronic version of the revised project abstract, and may be requested 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. The official notification of an award will be made by the Agency’s Grants Administration Division. Before or after an award, certain applicants will be expected to provide additional quality assurance documentation.
Expectations and responsibilities of NCER awardees are summarized in this section; see http://www.epa.gov/ncer/guidance for full terms and conditions associated with an award, including what activities require prior approval of the EPA.
A. Meetings: Principal Investigators will be expected to budget for, and participate in, periodic All-Investigators Meetings (also known as progress reviews) approximately once per year with EPA scientists and other awardees to report on research activities and to discuss issues of mutual interest.
B. Approval of Changes after Award: Prior written approval is required from the EPA if there is to be significant change in the research that deviates markedly from work described in the application. Examples of these changes are contained in 40 C.F.R. 30.25. Prior written approval is also required from the EPA for incurring costs greater than 90 calendar days prior to award.
C. Human Subjects: A cooperative agreement recipient 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, referred to as the “Common Rule.” No work involving human subjects, including recruiting, may be initiated before the EPA has received a copy of the applicant’s Institutional Review Board’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.
D. Animal Welfare: A cooperative agreement recipient must agree to comply with the Animal Welfare Act of 1966 (P.L. 89-554), as amended. All projects involving vertebrate animals must have approval from the applying organization’s Institutional Animal Care and Use Committee before issuance of an EPA cooperative agreement.
E. Data Access and Information Release: 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. All data sets, models, and databases developed under STAR cooperative agreements may become accessible to the public and therefore freely available to all researchers. If such data are requested by the public, the EPA must ask for it, and the awardee must submit it, in accordance with A-110 and EPA regulations at 40 C.F.R. 30.36.
A cooperative agreement recipient must agree to provide annual progress reports with associated summaries for posting on NCER’s web site, and a final report with an executive summary for web posting.
A cooperative agreement 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 cooperative agreement that were based on research supported by the cooperative agreement. NCER intends to post references to all publications resulting from the cooperative agreement on the NCER web site.
EPA’s full or partial support should be acknowledged in journal articles, oral or poster presentations, news releases, interviews with reporters and other communications. Any documents developed under the agreement 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 a 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 can 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 . Use of this graphic in oral and poster presentations is expected.
Further information, if needed, may be obtained from the EPA official indicated below. Email inquiries are preferred.
Thomas Barnwell; Phone: 202-343-9862; email: email@example.com